US20160050995A1

US20160050995A1 - Medical garment

Info

Publication number: US20160050995A1
Application number: US14/689,593
Authority: US
Inventors: Rhonda M. Bentley; Elsa Chi Abruzzo; Scott D. Wampler; Jose A. Perdomo, Jr.
Original assignee: Ben Gear LLC
Current assignee: Ben Gear LLC
Priority date: 2014-08-19
Filing date: 2015-04-17
Publication date: 2016-02-25

Abstract

A medical garment adapted to be worn by a patient, including: a body portion adapted to be worn on at least the upper torso of a patient, wherein the body portion includes at least one front panel having an outward-facing surface and an inward-facing, skin-contacting surface; an access opening extending across at least a portion of the body portion of the garment, wherein the access opening provides communicates between the outward- and inward-facing surfaces of the front panel; a pocket-forming outer panel affixed to the body portion of the garment such that a selectively-closeable pocket is provided between at least a portion of the front panel and the pocket-forming panel; and a medical device anchor secured within the pocket, wherein the anchor is adapted for releasable securement of a portion of a medical device (e.g., catheter tubing) within the pocket.

Description

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims priority to U.S. Provisional Patent Application No. 62/039,360, filed on Aug. 19, 2014, entitled “Medical Garment.” The entire disclosure of the foregoing provisional patent application is incorporated by reference herein.

BACKGROUND

A variety of medical devices are commonly attached to patients for extended periods of time, for a variety of reasons and in a variety of ways (e.g., adhesively, implanted, inserted into, attached via straps or other attachment members, etc.). For example, venous catheters, peritoneal catheters and pumps (such as those used for dialysis), gastric feeding tubes (“G-tubes”), various types of drainage tubes, various other types of vascular catheters, and various other medical devices are commonly implanted or otherwise attached to patients. In many such instances, a portion of the medical device (e.g., one or more conduits such as catheter tubes and/or electrical leads) extends out of or otherwise away from the patient's body. As a result, the patient often will have a portion of the medical device which must be secured in some manner, particularly when the device is not being used. If not secured in some manner, a loose portion of the medical device may get in the way of normal activities or may even be inadvertently pulled or become entangled to the point that the device itself is compromised and/or the patient suffers adverse consequences (e.g., irritation, pain, inflammation, or worse). In addition, a visible exterior portion of the medical device (e.g., catheter tubing or electrical leads) may also cause embarrassment for the patient, particularly children.
By way of example, venous catheters are commonly used in a variety of medical procedures for a variety of reasons. In many instances, venous catheters must remain in place for an extended period of time, such as for intravenous (“IV”) therapy, the frequent drawing of blood samples from a patient and/or other therapeutic or diagnostic medical procedures such as dialysis or apheresis. For example, IV therapy involves the administration of medications directly into a patient's vein through an inserted catheter. In some cases, IV therapy over an extended period of time is necessary, such as for administrating chemotherapy regimens, administering antibiotic regimens, or parenteral nutrition. Such extended duration IV therapy is typically accomplished through a peripherally inserted central catheter line (“PICC line”), or through a more central location with a central venous catheter (such as a Broviac catheter, Hickman line or a Groshong line).
A central venous catheter is typically a soft, flexible tube, with one or more internal lumens that has a larger diameter than a PICC line. A Broviac catheter is a central venous catheter with a smaller lumen as compared to a Hickman line, and is commonly used for small children. The central venous catheter is placed directly into a large vein in the neck, chest, or groin, and can remain in situ for extended periods of time. On the other hand, PICC lines and central venous catheters are more patient-friendly since they necessitate only one tube insertion rather than repeated ones.
Once inserted, a small length of the central venous catheter remains external to the patient, extending outwardly from, for example, the patient's chest (at a variety of possible locations), adjacent the patient's clavicle, or other region of the upper torso. In the case of multi-lumen catheters, while a single tube with multiple internal lumens extends outwardly from the patient's body, the multiple lumens branch into individual tubes from an external hub assembly and connectors (e.g., luer fittings) are typically provided at the ends of the individual tubes for connection to an infusion pump or other medical device. The external ends of the tube(s) of the central venous catheter are also typically capped in order to prevent contamination.
The external portion of a central venous catheter often dangles, unsupported, near the point of entry. There is a constant danger of pulling, dislodgement or other interference with the central venous catheter during normal daily activities or even during sleep. This movement or dislodgment may prevent the administered liquids from reaching the desired veins, or cause significant inflammation to the insertion point, air embolisms, arterial punctures, internal bruising, and/or blood clots. The problem of movement of the external portion of the catheter assembly is especially pronounced in young children undergoing long-term therapy with a central venous catheter.
Previous solutions to prevent movement of central venous catheters and other medical devices having dangling conduits (e.g., tubes and/or electrical leads) have included taping the external small length of the lines to the patient's skin with medical tape. These tapes often leave adhesive residues that are irritating to the skin. These irritations can lead patients to inadvertently scratch the insertion points, thereby moving the small length of the external catheter. While newer medical tapes reduce or virtually eliminate adhesive residue, such tapes are not as strong and still can irritate the skin surrounding the insertion point. The tape can also lead to pain, inflammation, infections, and/or reduced efficacy of the medical device. Furthermore, the medical tape often must be partially removed in order to access the catheter and then re-taped once the IV therapy or other medical treatment is completed. This removal of the tape and re-taping to the skin can result in significant irritation. Moreover, when the end of the central venous catheter is taped visibly from the outside of the patient's clothing, it presents an unsightly and disturbing appearance that can produce mental distress.
It is also desirable to protect catheter tubing or other portions of medical devices from being pierced or otherwise punctured or damaged due to movement. A pierced or punctured central venous catheter, for example, not only prevents administered liquids from reaching the desired vein, it may also allow bacteria or other contaminants to enter, causing internal infections in the patient.
By way of further example, various electrical medical devices are also commonly attached to patients, such as portable electrocardiography devices (also known as Holter monitors) and transcutaneous electrical nerve stimulation devices (also known as TENS devices). Holter monitors and TENS devices have a plurality of electrodes attached to the patient (e.g., adhesively), electrical leads extending from those electrodes, and a portable unit to which the electrical leads are connected. The portable unit generally should be secured in some manner so that the electrical leads remain connected thereto. This may be accomplished, for example, by hanging the portable unit from the patient's neck or clipping the unit to the patient's belt. While Holter monitors and portable TENS devices are designed to allow the patient to be mobile and engage in everyday activities, the patient still must be careful to not allow the electrical leads to become entangled or otherwise pulled (e.g., by becoming caught or snagged by something during normal activities) else the electrodes may become detached from the patient or even damaged.
While a variety of devices and techniques may exist for protecting, retaining and/or concealing various medical devices such as catheters or electrical leads, it is believed that no one prior to the inventors has made or used an invention as described herein.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings.

FIG. 1 depicts an elevation view of a portion of one embodiment of a medical garment including a tubing anchor and a pocket with a cover flap, worn on a patient.

FIG. 2 depicts a sectional view of the medical garment of FIG. 1, through line 2-2 thereof.

FIG. 3 depicts an elevation view of the reverse side of the portion of the medical garment shown in FIG. 1, viewed through line 3-3 of FIG. 2.

FIG. 4 depicts a sectional view of the medical garment of FIGS. 1-3 as worn on a patient with the cover flap folded over the tubing anchor.

FIG. 5A depicts a plan view of one embodiment of a tubing anchor used in the medical garment of FIGS. 1-4.

FIG. 5B depicts a sectional view of the tubing anchor of FIG. 5A, viewed through line 5B-5B thereof.

FIG. 6A depicts a plan view of an alternative embodiment of a tubing anchor.

FIG. 6B depicts a sectional view of the tubing anchor of FIG. 6A viewed through line 6B-6B of FIG. 6A.

FIG. 7A depicts a longitudinal sectional view of another alternative embodiment of a tubing anchor which includes a closure member.

FIG. 7B depicts a longitudinal sectional view of the tubing anchor of FIG. 7A, with the anchor in a closed position securing a catheter tube.

FIG. 7C depicts a transverse sectional view of the tubing anchor of FIG. 7B, viewed through line 7C-7C thereof.

FIG. 8A depicts a longitudinal sectional view of yet another alternative embodiment of a tubing anchor which includes a closure member.

FIG. 8B depicts a longitudinal sectional view of the tubing anchor of FIG. 8A with the anchor in a closed position securing a catheter tube.

FIG. 8C depicts a transverse sectional view of the tubing anchor of FIG. 8B, viewed through line 8C-8C thereof.

FIG. 9A depicts a perspective view of a further embodiment of a tubing anchor.

FIG. 9B depicts a sectional view of the tubing anchor of FIG. 9A, through line 9B-9B thereof.

FIG. 9C depicts a perspective view of the tubing anchor of FIG. 9A with three secured lines of tubing.

FIG. 9D depicts a sectional view of the tubing anchor of FIG. 9C, through line 9D-9D thereof.

FIG. 10 depicts a front view of an alternative embodiment of a medical garment worn by a patient, with the pocket closed and catheter tubing extending out of the pocket and secured over the patient's shoulder, and the fabric stitching omitted for purposes of clarity.

FIG. 11 depicts the same garment and patient as in FIG. 10, with the catheter tubing stored in the garment pocket.

FIG. 12 depicts a rear view of the garment and patient of FIG. 10.

FIG. 13 depicts the same garment and patient of FIG. 10, with the outer panel (and pocket) opened.

FIG. 14 depicts a front view of the garment shown in FIG. 10, with the pocket in the closed position.

FIG. 15 depicts a front view of the garment shown in FIG. 10, with the outer panel (and pocket) opened.

FIG. 16 depicts a front view of the garment shown in FIG. 10, with the outer panel and upper front panel opened.

FIG. 17 depicts a front view of the garment shown in FIG. 10, with the outer panel and upper and lower front panels opened.

FIG. 18 is an enlarged view of the left shoulder area of the garment shown in FIG. 10, with the shoulder strap opened.

FIG. 19 depicts an enlarged view of the pocket region so the garment shown in FIG. 10, with catheter tubing secured by an anchor mounted in the pocket.

FIG. 20A depicts the anchor used in the garment of FIG. 10.

FIG. 20B depicts a cross-sectional view of the anchor of FIG. 20A, taken along the line 20A-20A thereof.

FIG. 21 depicts a front view of an alternative embodiment of a medical garment.

FIG. 22 depicts a front view of another alternative embodiment of a medical garment, configured for use by an infant or toddler.

FIG. 23 depicts a front view of the garment shown in FIG. 22, with the outer panel (and pocket) opened.

FIG. 24 depicts a rear view of the garment shown in FIG. 22.

FIG. 25 depicts a front view of a medical garment system comprising an alternative embodiment of a medical garment with the outer panel (and pocket) opened, and a fabric bag.

FIG. 26 depicts a front view of yet another alternative embodiment of a medical garment, with the outer panel (and pocket) opened.

FIG. 27 depicts a sectional view of the tubing anchor used with the garment of FIG. 26.

FIG. 28 depicts a front view of another alternative embodiment of a medical garment, with the outer panel upper front panel opened.

The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples should not be used to limit the scope of the present invention. Other features, aspects, and advantages of the versions disclosed herein will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the versions described herein are capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
For example, although various embodiments of medical garments will be described for use by a patient having a central venous catheter in place, embodiments of the medical garments described herein can be used for a wide variety of medical devices attached to a patient, by implantation or otherwise, for any length of time. Medical garments described herein may be used with any of a variety of medical devices which include or comprise one more conduits used for medical treatment or diagnosis, including conduits which comprise catheters as well as electrical conduits such as electrical leads. For example, medical garments according to some embodiments of the present invention can be adapted for use with peritoneal catheters and pumps (such as those used for dialysis), gastric feeding tubes (“G-tubes”), various types of drainage tubes, various other types of vascular catheters, electrical leads, including medical devices which include or require electrical leads (e.g., Holter monitors or portable TENS devices), airway tubes, and various other medical devices. Thus, the present invention is not limited to medical garments specifically adapted for or intended to be used by patients having a central venous catheter in place.
Embodiments described herein provide a medical garment which facilitates a patient's engaging in normal daily activities while a medical device such as a central venous catheter remains attached to the patient. Garments described herein not only conceal the medical device when it is not being used (and in some cases while it is being used), but also prevent portions of the medical device becoming entangled or pulled during normal activities of the patient.
Embodiments of the medical garment described herein include a storage pocket, and an access opening located within the pocket through which a portion of a medical device attached to a patient (e.g., a portion of catheter tubing and/or a component of a medical device such as electrical leads) may pass from the interior of the garment into the pocket. In some embodiments, the access opening may also be used to access the patient adjacent the garment's access opening in order to, for example, examine and/or clean a catheter exit site in the patient's skin without having to remove the garment and, in some instances, without having to open the garment (other than the pocket).
Some embodiments further include an anchor secured (permanently or removably) within the pocket, wherein the anchor is adapted to retain a portion of a medical device (e.g., catheter tubing or other conduit such as electrical leads) in order to limit movement of the retained portion. In these embodiments, the anchor is load bearing with respect to the portion of the medical device extending from the patient through the access opening into the pocket and provides strain relief. The load bearing and strain relief features of the anchor help to prevent or reduce the transfer of a pulling force on the medical device to the location where the device is attached to or otherwise enters the patient. For example, when a catheter tube is retained by the anchor, the anchor (and the garment itself) will resist any pulling force applied to the catheter tube (by gravity or otherwise), thereby reducing or eliminating force applied to the catheter at the site of insertion into the patient. In other words, the anchor helps to prevent the catheter (or other medical device portion retained by the anchor) from tugging on the catheter exit wound (or other location where the medical device is attached to or enters a patient).
Some embodiments are also configured to allow the medical garment to be donned or removed by a patient (or positioned on or removed from a patient) without the need to remove or disconnect the medical device attached to the patient, even if that medical device is being used at the time. For example, embodiments allow the garment to be donned or removed by a patient having a central venous catheter extending from their chest, even while the catheter is being used to infuse medication into the patient.
In one particular embodiment, for example, a medical garment comprises a body portion adapted to be worn on at least the upper torso of a patient, wherein the body portion includes at least one front panel having an outward-facing surface and an inward-facing, skin-contacting surface, as well as back panel having an outward-facing surface and an inward-facing, skin-contacting surface. At least one access opening communicates between the outward- and inward-facing surfaces of the front panel, and in one embodiment extends across at least a portion of the width of the front panel. The access opening may be provided in a unitary front panel (e.g., a slit formed in, and extending across a portion of the width of the front panel). Alternatively, the front panel comprises upper and lower front panels (e.g., FIGS. 10-20), with the access opening provided between the lower edge of the upper front panel and upper edge of the lower front panel. In still other embodiments, the front panel may comprise three or more panels arranged in vertical alignment, such that an access opening is provided between each pair of adjacent panel edges.
A pocket-forming outer panel is affixed to the front panel such that a selectively-closeable pocket is provided between the outer panel and at least a portion of the front panel, with the access opening located within the pocket (at least when the pocket is closed) and the extending downwardly beneath the access opening. (In some embodiments, the pocket also extends upwardly from the access opening.)
An anchor is secured to the outward-facing surface of the front panel within the pocket (at least when the pocket is in the closed position), such that the anchor is concealed behind the outer panel when the pocket is in its closed position. The anchor is adapted to releasably secure a portion of a medical device (e.g., catheter tubing or other conduit) within the pocket. By way of one specific example, the anchor comprises a clamp which securely holds a portion of a medical device without interfering with its normal use (e.g., securely clamps a catheter tube but without compressing the catheter tube such that the internal lumen is closed or reduced in diameter).
Any of a variety of conduit anchors may be employed on the medical garment. For example, a clamping-type anchor comprising a clamshell assembly adapted for clamping securement of a catheter or other conduit between adjacent portions (e.g., opposing faces) of the clamshell assembly can be employed. The clamshell assembly is configured to clampingly secure the catheter tubing between a base portion and a clamping portion without exerting so much clamping pressure that the internal lumen of the catheter tubing is closed or reduced in diameter. The clamshell assembly anchor may be configured as a single, unitary structure comprising a base member and a clamping member which are hingedly connected at one end (e.g., FIG. 9), or may be a two-piece construction such as that depicted in U.S. Pat. No. Des. 630,317, which issued on Jan. 4, 2011 (which patent is incorporated by reference herein).
For a unitary clamshell arrangement, the clamp may be normally biased to an open position whereby the base and clamping members are spaced apart from one another to facilitate the placement of catheter tubing or other conduit between the base and clamping members (e.g., FIG. 9 herein). With such an anchor, the free ends of the base and clamping members (i.e., the end opposite the hinged end) may be adapted for selective engagement with one another in order to retain the anchor in its closed position (e.g., FIGS. 9C and 9D). Alternatively, a unitary clamshell-type clamp may be resiliently biased to a closed position (e.g., FIG. 20A herein), and opened by urging the free ends of the base and clamping members away from one another to allow catheter tubing and the like to be placed therebetween. Upon release of the free ends of the base and clamping members, the clamshell-type clamp with return to its closed position, thereby clampingly securing the catheter tubing therein. As further described herein, in some embodiments one or more surfaces of the anchor may be lined with a compressible material such as foam in order to control the clamping force applied to the conduit and to facilitate conduit retention within the anchor.
FIGS. 1-4 depict one embodiment of a medical garment (10), as worn by a patient who has a venous access catheter (100) in place. Catheter tubing (101) from the venous access catheter (100) extends from the entry site in the patient's chest, beneath the garment. Medical garment (10), like the other medical garments described herein, can be generally shaped and styled as any type of garment worn over at least the upper torso of a patient, including, without limitation, shirts, jerseys, smocks, vests, parkas, coats, t-shirts, blouses, and bodysuits, including infant and toddler bodysuits which cover the upper torso and at least a portion of the lower torso (sometimes referred to as a “sleeper” when portions or all of the child's legs are covered).
Medical garment (10) includes a body portion comprising a front panel (12) having an outward-facing surface (14), an access opening (16) extending through the front panel (12), and an anchor (40) that is attached to the front panel (12). The anchor will typically be attached to the outward-facing surface (14) beneath the access opening (16). As used herein, “beneath” means lower or below, when the garment is worn by a patient standing erect.
The medical garment (10) also includes an outer panel (20) attached to the outward-facing surface (14) of the front panel (12), such that a pocket (P) extends downwardly from anchor (40). The pocket is generally configured to retain a distal length (102) of the tubing (101) that extends below the tubing anchor (40). It will be understood, however, that the pocket may be used to retain any of a variety of items, as further described herein. FIG. 3 shows a view from inside the garment (10), facing the inside surface (13) of the front panel (12).
The anchor (40) in the embodiment of FIGS. 1-4 is adapted to receive and retain a portion of catheter tubing (101), and generally includes a base (42) which serves as a surface for attachment of the anchor (40) to the front panel (12) of the garment. Extending from the base (42) are a pair of opposed, parallel ridges (44A, 44B) forming or defining an elongated channel (48) therebetween. The channel (48) is configured to accept a relatively-short portion of the length of tubing (101), and to retain releasably the portion of tubing (101) within the channel (48). The length of the channel need only be sufficiently long to retain the tubing; for example, from about 1 cm to about 4 cm. Anchor (40) may be attached to the front panel of the garment in a variety of ways, such as using adhesive (43) (see FIG. 5B).
The tubing (101) can be retained by anchor (40) in a variety of ways, such as the shape or other feature of one or both of ridges (44), and/or a fastener attached to the base (42) of the anchor (40). The medical garment itself, including outer panel (20), may also be adapted to retain the tubing (101) on or in the anchor (40). The anchor is configured to retain the tubing to anchor (40) during normal daily activities which might otherwise pull the catheter away from the patient causing discomfort, irritation and the like.
As an alternative, the anchor (40) may be configured to include a plurality of channels (48) in order to provide for the releasable retention of a plurality of catheter tubes. In particular, anchor (40) may include a plurality of pairs of opposing, parallel ridges (44A, 44B), which may, for example, extend parallel to one another so as to provide a plurality of parallel, tube-receiving channels (48). As yet another alternative, a plurality of separate anchors (40) may be provided on the medical garment, adjacent to one another in order to provide releasable retention of a plurality of catheter tubes and/or at different locations within the garment pocket in order to provide more than one location for securing one or more catheter tubes within the garment pocket.
In the embodiment shown in FIGS. 5A and 5B, the ridges (44A, 44B) of the tubing anchor (40) define a channel (48) having a concave channel cross-section that defines a semicircular or slightly more closed circular opening. The tubing is pressed into channel (48), where it is held in place by the resilient nature of the ridges (44A, 44B) of the anchor (40). In some embodiments, the tubing anchor (40) is made of a material (e.g., silicone) that tends to adhere to the tubing (e.g., silicone tubing), thereby further helping to retain the tubing (101) under most daily activities. Alternatively, or in addition thereto, the tubing anchor can include a channel liner (similar to liner (255) in FIG. 7A, described below) that lines at least a portion of the interior surface of the channel in order to aid in retaining the tubing within the channel (48). The channel liner can comprise, for example, a silicone or similar material that aids in retaining the tubing within the channel or even an adhesive. The channel liner can also comprise or include a compressible material (e.g., a foam) that can be easily compressed by the outer surface of the tubing (101). This will improve the grip of the tubing anchor on the length of tubing, and permit the retention of tubing of a variety of diameters, depending upon the thickness of the channel liner material and its range of compression.
In addition, a separate retainer member can be positioned over the ridges (44) of the tubing anchor (40) after the tubing (101) has been positioned within the channel (48) in order to prevent the tubing from escaping channel (48). For example, a retaining patch (26) can be positioned on an inner surface of a flap (24) that extends from the top edge (22) of outer panel (20). When the flap (24) is folded upwardly to cover the access opening (16) (and the tubing anchor) and thereby close the pocket provided between the outer panel (20) and the front panel (12), as shown in FIG. 4, the retaining patch (26) registers with and covers the ridges (44A, 44B) and channel (48) of the tubing anchor (40), aiding in the retaining of the tubing (101) within the channel.
The flap (24) and/or the front panel (12) may also include one or more fasteners for maintaining the flap in the closed position. A variety of fasteners may be used for the releasable attachment of flap (24) to front panel (12), including conventional buttons (and corresponding button holes or loops), hook and bar fasteners, hook and loop fasteners (e.g., Velcro® brand), and mating snaps. In the embodiment shown, fasteners (28) comprise male (or female) snaps which are located to align with corresponding female (or male) snaps (30) located on the front panel (12) above the access opening (16). The retaining function of the retaining patch (26) can be augmented by including magnetically-attracting elements within the anchor (40) and the retaining patch, or by including a pair of mating fasteners (not shown) on each of the retaining patch (26) and anchor (40).
An alternative embodiment of a snap-fit tubing anchor (140) is depicted in FIGS. 6A and 6B, wherein the ridges (144A, 144B) include inwardly-extending distal edges (149A, 149B), which define a channel (148) having a substantially circular cross section, with a narrow gap (150) between the distal edges (149A, 149B). The material of the tubing anchor (140) may be a resilient material capable of flexing or bending under modest force. The gap (150) between the opposed distal edges is configured to be less than the diameter of the tubing (101). Thus, the tubing (101) can be inserted into the channel (148) by pressing and rolling the length of the tubing through the narrow gap (150) and down into the channel (148), until the distal edges (149A, 149B) snap over the top surface of the tubing (101) and retain the tubing within the channel (148).
Like anchor (40), anchor (140) may be configured to include a plurality of channels (148) in order to provide for the releasable retention of a plurality of catheter tubes. Thus, anchor (140) may include a plurality of pairs of opposing, parallel ridges (144A, 144B), which may, for example, extend parallel to one another so as to provide a plurality of parallel, tube-receiving channels (148). Alternatively, a plurality of separate anchors (140) may be provided on the medical garment, adjacent to one another in order to provide releasable retention of a plurality of catheter tubes and/or at different locations within the garment pocket in order to provide more than one location for securing one or more catheter tubes within the garment pocket. Also, the tubing anchor (140) can include a channel liner (similar to liner (255) in FIG. 7A, described below) that lines at least a portion of the interior surface of the channel (148) in order to aid in retaining the tubing within the channel.
One suitable material for the anchor (140) is silicone or another resilient material, particularly a resilient material that is MRI-, X-Ray- and/or CT-compatible (transparent) material. As further discussed herein, embodiments of the medical garments described herein are substantially or entirely non-metallic, including the various fasteners and fastening arrangements such as snaps used to close various portions of the garment. In this manner, such medical garments are MRI-compatible and will not pose a risk to the patient during MRI imaging.
FIGS. 7A-7C depict yet another alternative embodiment of a tubing anchor (240). Tubing anchor (240) combines a snap-fit channel (248) similar to that of anchor (140), as well as a clamshell arrangement for locking retention of the catheter tubing within the channel (248). Anchor (240) includes a closure member (260) which is hingedly connected at one end thereof to an end portion (245) of a base member (242). The base member (242) has a garment attaching surface (243) through which the tubing anchor (240) is attached to the garment (e.g., by and adhesive or other suitable fastening means). The tubing anchor (240) includes at least one tube-receiving channel (248) having a channel liner (255).
The closure member (260) is configured to pivot closed (FIG. 7B) over the channel (248) through the hinged connection with the base member (242). While the hinged connection may be provided by a single resilient fold or bend such as in the embodiment of FIG. 9, anchor (240) includes a first hinge (262) at one end (245) of the base (242) member, a second hinge (263) at one end of the closure member (260), and a hinge segment (264) provided between the first and second hinges. The first hinge (262) is hingedly attached to one end of a hinge segment (264), which in turn is hingedly attached at its other end to the second hinge (263). As seen in FIG. 7B, the hinge segment (264) spaces the closure member (260) away from the base (242) of the anchor (240), allowing the retaining surface (265) of the closure member (250) to register with the gap (250) of channel (248). The retaining surface (265) has a concave profile in the longitudinal direction of the channel (248) to provide a substantially completely-cylindrical channel (248) for the tubing (101) when the anchor is closed (as shown in FIG. 7B).
In the illustrated embodiment, the retaining surface (265) and the channel liner (255) comprise a compressible material such as a compressible foam material, particularly a soft foam material, that can be easily compressed by the outer surface of the tubing (101). The compressible material improves the grip of the tubing anchor on the length of tubing, and can also permit the retaining of tubing of different diameters depending upon the thickness of the compressible material and its range of compression. The length of the anchor (240) in the closed position shown in FIG. 7B is about 1.5-3 inches, or about 2.0-2.5 inches, and the width (the transverse direction shown in FIG. 7C) is about 0.3-1.0 inches, or about 0.5 inches.
The end of anchor (240) opposite that of the hinge is configured to releasably lock the anchor in its closed position using mating fasteners provided at the ends of the closure and base members. Thus, distal end (267) of the closure member (260) includes a first lip (268) at the end of a resilient arm that is configured to fasten to a mating second lip (278) provided at the end of a similar resilient arm extending upwardly from the opposed end (246) of the base member (242). In the illustrated embodiment, the mating first and second lips comprise a latch and a catch arrangement. However, other mating fastener arrangements can be used, including mating magnetically-attracting materials, hook-and-loop mechanical fasteners (also known as Velcro®), and the like.
With tubing 101 is positioned within channel (248), the closure member (260) is pivoted over the base member (242) so that the retaining surface (265) closes over the tubing (101). A force (F1) applied near the end of the closure member (260) causes first lip (268) slide past second lip (278) until the lips engage one another (as shown in FIG. 7B). To release the closure member from the base member, a force (F2) is applied to the closure member intermediate the fastener (268) and the retaining surface (265), causing the first lip (268) to pivot outwardly away from and out of engagement with the second lipe (278), thereby opening the anchor (240) and allowing the tubing (101) to be removed from the anchor.
FIGS. 8A and 8B depict another alternative embodiment of a clamshell-type tubing anchor (340) that includes a closure member (360) extending pivotally from one end (345) of a base member (342). The tubing anchor (340) includes a pair of opposed tubing retainers (370, 380) that provide a means for retaining the tubing (101). The tubing retainers (370, 380) may comprise, for example, a resiliently compressible foam. The first tubing retainer (370) is affixed to an upper surface of the base (342) (e.g., using adhesive), and the second tubing retainer (380) is affixed to an upper surface of the closure member (360). The closure member (360) is configured to pivot over the base (342) through hinge segment (364). The base (342) has a garment attaching surface (343) through which the tubing anchor (340) may be attached to the garment, such as using an adhesive or other fastening means.
The end of anchor (340) opposite that of the hinge is configured to releasably lock the anchor in its closed position using mating fasteners provided at the ends of the closure and base members. Thus, distal end (367) of the closure member (360) includes a first fastener (368) (e.g., a lip) that is configured to fasten to a mating second fastener (378) (e.g., a lip) at an opposed end (346) of the base (342). In the illustrated embodiment, the mating first and second fasteners are a latch and a catch mechanism, although other mating fasteners can be used, including mating magnetically-attracting materials, hook-and-loop mechanical fasteners (also known as Velcro®), and the like. A first hinge (362) at the end (345) of the base (342) is hingedly attached to one end of a hinge segment (364), which is hingedly attached at its other end to a second hinge (363) at the end of the closure member (360). A force applied near the end (367) of the closure member (360) will secure the mating fasteners (368, 378) to one another in the manner described above for anchor (240). To release the closure member of anchor (340), a force F3 is applied to the closure member intermediate the centerpoint and the end (367), which causes the first fastener (368) to pivot outwardly away from and out of engagement with the second fastener (378). A push button (380) can be positioned at a suitable position for application of the releasing force (F3).
As seen in FIG. 8B, the hinge segment (364) spaces the closure member (360) away from the base (342) when in the closed position, allowing the first and second tubing retainers (370, 380) to register and confront one another, typically separated by a small space or gap. The tubing retainers (370, 380) are typically a rectangular shape, and made of a compressible foam material that conforms to the shape of the diameter of the tubing (101) that is laid across the base (342) and secured with the closure member (360). The first and second compressible foam members provide a means for securing the tubing in position from both lateral and longitudinal movement when the closure member is disposed in its pivot position over the base. The closure member is secured in its pivoted position over the base by the mating fasteners.
FIGS. 9A-9D depict a further embodiment of a clamshell-type tubing anchor (440) that includes a closure member (460) extending pivotally away from a base member (442) via a hinge segment (464). The tubing anchor (440) includes a tubing retainer (470) that lines the inner surfaces of the tubing anchor (440), including a base retainer member (471) and a closure retainer member (472), which provide a means for retaining the tubing (101). The closure member (460) is configured to pivot over the base (442) through the hinge segment (464). The base (442) has a garment attaching surface (443) through which the tubing anchor (440) is attached to the garment.
FIGS. 9A and 9B depict the tubing anchor (440) in an unconstrained, open state with the closure member (460) angled over and away from the base (442). Unlike the previous clamshell anchors, closure member (460) is normally biased to a partially open position, wherein the closure member (460) extends upwardly away from the base member (442) at an angle of less than 90 degrees, or even less than 45 degrees.
The closure member (460) includes a first fastener element comprising distal edge (468). The base (442) includes a mating second fastener (478) that includes an inner ledge (479) for releasably engaging the edge (468) of the closure member (460), and restraining the closure member (460) against the biasing, resilient force of the hinge (464) which biases the anchor to the partially open position of FIGS. 9A and 9B. The second fastener (478) also includes an outwardly extending release arm (480) which, when compressed by a force F (of a finger, for example) urges the inner ledge (479) upwardly and outwardly so as to allow for the release of edge (468) of the closure member.
As shown in FIGS. 9C and 9D, the hinge segment (464) spaces the closure member (460) away from the base (442) in the closed position, allowing the first and second tubing retainers (471, 472) to register and confront one another, either in direct contact or separated by a small space or gap. The tubing retainers (471, 472) are typically made of a compressible foam material that conforms to the shape of the tubing (101), including for example three separate tubing sections (101A, 101B and 101C) of the same of different sizes, laid across the base (442) and secured by the closure member (460). The first and second compressible foam members provide a means for securing the tubing in position from both lateral and longitudinal movement when the closure member is disposed in its closed position over the base (FIGS. 9C and 9D). The closure member is secured in its pivot position over the base by the mating fasteners. The length and width dimension of the anchor (340) can be similar to those of anchor (240).
As noted above, embodiments of anchors (40, 140, 240, 340, 440) include one or more tubing retainers (or liners) comprising a resiliently compressible material such as a polymeric foam in order to not only aid in retaining the tubing (or other conduit such as electrical leads) within the anchor, but also to prevent too much force being applied to the conduit such that a tubing, for example, is pinched closed and/or the conduit is damaged. Any of a variety of materials and thicknesses of material may be used. In one specific embodiment, for example, the tubing retainer(s) is about ⅛th inch thick.
An example of a suitable retaining material is a compressible foamed polymeric material that can be easily compressed by the outer surface of the tubing (101), and having a resiliency sufficient to recover to the full rectangular block shape when the tubing is released. The retaining material improves the grip of the tubing anchor on the length of tubing, and can permit the retaining of tubing of different diameters, depending upon the thickness of the retaining material and its range of compression. Any flexible polymeric material which can be foamed having sufficient compressibility and recovery/resiliency can be employed, including polymers of ethylene, propylene, urethane, vinyl chloride, vinyl acetate, diisocyanate, cellulose acetate and isobutylene, and including homopolymers and copolymers thereof. Other monomers can include vinylidene chloride, vinyl esters of carboxylic acids, e.g., vinyl acetate, vinyl propionate, vinyl butyrate and vinyl benzoate, esters of unsaturated acids, e.g., alkyl acrylates such as methyl acrylate, ethyl acrylate, propyl acrylate, butyl acrylate, allyl acrylate, and the corresponding esters of methacrylic acid; vinyl aromatic compounds, e.g., styrene, ortho-chlorostyrene, parachlorostyrene, 2,5-dichlorostyrene, 2,4-dichlorostyrene, paraethylstyrene, vinyl naphthalene and a-methyl tyrene, dienes such as butadiene and chlorobutadiene, unsaturated amides such as acrylic acid amide and acrylic acid anilide; unsaturated nitriles such as acrylic acid nitrile; and esters of a,P-unsaturated carboxylic acids, e.g., the methyl, ethyl, propyl, butyl, amyl, hexyl, heptyl, octyl, allyl, methallyl, and phenyl esters of maleic, crotonic and fumaric acids and the like. Such polymers can normally be compounded into plastisol form with a blowing agent and a high concentration of a suitable organic plasticizer so as to result in stabilized foams having the suitable recovery and compression characteristics.
The illustrated tubing anchor can be permanently affixed to the garment, using, for example, a permanent adhesive, stitching, or other well-known methods of securing material to a garment.
Alternatively, the tubing anchor can be temporarily and selectively attached to any surface of the garment, as needed or desired. Temporary attachment of the device to a garment means that the device is fixed to the garment and remains affixed during normal daily routines, but can be readily removed from the garment without damaging the garment. An example of temporary affixing means includes an adhesive material, including a pressure sensitive adhesive (PSA) or equivalent adhesive material. The adhesive material is typically applied to the back surface of the base of the anchor. A plastic release film can be attached to the surface of the adhesive to prevent dust, dirt, and premature attachment until the location of attachment is determined. Other examples of temporary attachment means include a safety pin built into the bottom surface of the garment attaching surface of the anchor, or a mechanical hook-and-loop fastener element, one of the hook or loop elements attached to the garment attaching surface, and the other attached to the garment.
In some embodiments, the anchor may be designed as a replaceable component of the garment. For example, the anchor may include an adhesive (e.g., PSA) on its garment attaching surface (e.g., the bottom surface of the anchor), covered by a release film. When the anchor is needed, the release film is removed and the garment is affixed to a surface of the garment (e.g., to the front panel of the garment, within the pocket). Should the anchor need to be replaced (e.g., no longer clamps tubing sufficiently or the adhesive wears off) or moved to a new location, the old anchor is removed and a new one attached to the garment in the same manner. More than one anchor may also be attached to the garment in order to, for example, provide multiple anchoring locations for tubing or other portions of a medical device.
FIGS. 10-20 depict another alternative embodiment of a garment (510) having a pocket (P) for retaining a medical device (or a portion of a medical device) such as catheter tubing (T) therein (see FIG. 11). Like the other medical garment embodiments described herein, garment (510) is not limited for use with catheter tubing. For example, garment (510) is suitable for use in conjunction with a wide variety of medical devices including, for example, peritoneal catheters and pumps (such as those used for dialysis), gastric feeding tubes (“G-tubes”), various types of drainage tubes, various other types of vascular catheters, electrical leads, including medical devices which include or require electrical leads (e.g., Holter monitors or portable TENS devices), airway tubes, etc. The pocket (P) may be used to store a portion of the medical device such as catheter tubing (either excess tubing or when the catheter is not being used), a portable pump, or a portable monitor or other electronic device having electrical leads connected to the patient (e.g., a Holter monitor or TENS device). In addition, the pocket (P) can also be used for storing or holding a wide variety of other things besides a medical device connected to the patient, such as hot or cold packs for patient comfort, the patient's cell phone, or other personal items.
When access or use of the medical device is needed, the pocket may be easily opened without removing the garment. In addition, as seen in FIGS. 10 and 13, when the medical device is, for example, a catheter, the garment (510) and pocket (P) are configured such that the catheter tubing (T) may extend from the pocket (P) for use (e.g., medication infusion). An anchor (586) (e.g., a clip) is also provided inside the pocket for securing the catheter tubing within the pocket while still allowing the catheter tubing to be used for its intended purpose. An access opening (570) is also provided, adjacent anchor (586), and the garment (510) is also configured to allow full access to a wearer's torso without having to remove the garment. This allows, for example, a catheter port in the wearer's chest to be cleaned, new tubing to be connected to a catheter port, and other medical procedures performed without removing the garment. Similarly, the garment (510) may be donned or removed by a patient or caregiver, even if the patient is in a supine or reclining position, without the need to remove the catheter tubing (or other medical device) or even disconnect the catheter tubing from an external device (e.g., an infusion pump).
Garment (510) generally comprises a neck opening (512) adapted to receive a wearer's (e.g., a patient's) neck therethrough, as well as right and left arm openings (514) adapted to receive a wearer's arms therethrough. Neck opening (512) and arm openings (514) may be formed in a variety of ways, such as by affixing (e.g., by stitching) binding strips to the garment panels, as shown. The bottom end (513) of the garment (510) may be finished with a stitched hem, as shown, or in other ways known to those skilled in the art. It should also be pointed out that FIG. 10, for purposes of clarity, does not depict the various stitching used to attach the fabric panels and form various hems and other conventional garment reinforcing structures (e.g., hems). Such stitching is shown, however, in FIGS. 11-20.
Although garment (510) is depicted as being sleeveless, alternative embodiments include short or long sleeves affixed at arm openings (514) in a variety of manners known to those skilled in the art. For example, sleeves may be conventionally attached via stitching, or removably attached using, for example, snaps or other suitable fasteners. Even with sleeves, however, garment (510) can be fully opened and donned or removed without having to remove or disconnect catheter tubing (or other medical devices attached to the patient).
The access opening in garment (510) may be provided by a slit formed in the front panel of the garment, at any of a variety of desired locations. Alternatively, in the embodiment depicted in FIGS. 10-20, garment (510) includes an upper front panel (520) and a lower front panel (540), with the access opening that communicates between the interior of the garment and the pocket located between the upper and lower front panels, as described below. Right and left side panels (560A, 560B), as well as a back panel (580) are also provided.
As used herein, right and left are defined from a wearer's perspective. Of course one skilled in the art will recognize that the various features described herein with reference to the right and left of the garment can be reversed without departing from the present disclosure. For example, while the pocket and front panels of the medical garment (510) depicted in FIGS. 10-20 open on the left, the arrangement of panels and other components of garment (510) can be reversed such that the pocket and front panels open on the right.
In the specific embodiment depicted, and as best seen in FIG. 14, upper front panel (520) is adapted to generally cover the wearer's chest and lower front panel (540) to generally cover the wearer's abdomen. Back panel (580) is configured to not only form the entire back portion of the garment, but also to extend over the shoulders of the garment between neck opening (512) and the right and left arm openings (514). Thus, left and right shoulder portions (581A, 581B) are provided on back panel (580). It will be understood, however, that the arrangement and configuration of the upper and lower front panels may be modified, as desired, particularly to adjust the height of the access opening (570) (described below). Similarly, garment (510) may be further modified to provide a variety of additional features or structures, such as a strapped arrangement wherein the shoulder portions (581A, 581B) are replaced by straps connecting the front and back portions of the garment, as well as bust support features for female patients (e.g., similar to a sports bra construction).
As mentioned above, the access opening in the exemplary embodiment shown in FIGS. 10-20, is located between the upper and lower front panels (520, 540). However, in this particular arrangement, upper and lower front panels (520, 540) do not overlap one another. Instead, the lower edge (522) of upper front panel (520) is located adjacent to, but does not overlap, the upper edge (542) of lower front panel (540), such that an access opening (570) is provided between lower edge (522) and upper edge (542). In some embodiments, the space between lower edge (522) and upper edge (542) is less than about 0.25 inches, while in other embodiments the space is less than about 0.125 inches. In still further embodiments, the space between lower edge (522) and upper edge (542) is about 0 inches.
It is also contemplated that the lower edge of the upper front panel and the upper edge of the lower front panel may overlap, with the access opening provided therebetween, such as depicted in FIG. 28. The overlap may be, for example, a distance of about 2 inches or less, about 1 inch or less, or about 0.5 inches or less.
In the embodiment shown in FIGS. 10-20, upper front panel (520) and lower front panel (540) not only comprise separate fabric panels, they are not directly affixed to one another. Instead, upper and lower front panels (520, 540) are affixed to right side panel (560A) along their right-most sides (524A, 544A), such as by stitching. Thus access opening (570) extends across the entire width of the upper and lower front panels (i.e., except where the front panels are stitched to right side panel (560A)), as shown. Alternatively, particularly when the upper and lower front panels overlap to any extent, the upper and lower front panels may be stitched (or otherwise affixed) to one another at their right edges.
The left-most sides (524B, 544B) of the upper and lower front panels (520, 540) are not permanently affixed to left side panel (560B). Instead, as further described below, mating fasteners are provided for releasably attaching left-most sides (524B, 544B) of upper and lower front panels (520, 540) to left side panel (560B).
Upper front panel (520) extends upwardly to neck opening (512), and to right and left upper ends (525A, 525B) along either side of neck opening (512). Right upper end (525A) is affixed (e.g., by stitching) to the corresponding lower edge of right shoulder portion (581A) of back panel (580) (i.e., the portion of back panel (580) which extends over the right shoulder). The left upper end (525B) is not permanently affixed to the left shoulder portion (581B) of back panel (580). Instead, as further described below, mating fasteners are provided for releasably attaching (directly or indirectly) left upper end (525B) of upper front panel (520) to the left shoulder portion (581B) of back panel (580).
Right and left side panels (560A, 560B) extend downwardly from the right and left shoulder portions (581A, 581B) of back panel (580), spaced laterally outward with respect to the upper and lower front panels, and are affixed to the shoulder panels (581A, 581B) at their upper ends (e.g., by stitching). Along the sides of garment (510), right and left side panels (560A, 560B) extend from arm openings (514) (i.e., beneath a wearer's armpit) to the lower edge (513) of the garment. Thus, the outermost sides (562A, 562B) of right and left side panels (560A, 560B) are affixed to the outermost sides (582A, 582B) of back panel (580) (e.g., by stitching, which is not shown in the figures). As mentioned previously, the innermost right side (563A) of right side panel (560A) is affixed to the right-most sides (524A, 544A) of the upper and lower front panels (520, 540), such as by stitching. As further described herein, the innermost side portion (563B) of left side panel (560B), on the other hand, is adapted for releasable attachment to the left-most sides (524B, 544B) of upper and lower front panels (520, 540).
In the exemplary embodiment shown in FIGS. 10-20, side panels (560A, 560B) are tapered in width. At their upper ends, the innermost sides (563A, 563B) extend inwardly to a point intermediate neck opening (512) and arm openings (514) (in the exemplary embodiment shown, nearer to the arm openings). Side panels (560A, 560B) are curvingly tapered along their lengths such that the side panels are widest at their lowermost ends. Accordingly, at bottom edge (513) of garment (510), the innermost sides (563A, 563B) of side panels (560A, 560B) extend inwardly to a point which is approximately vertically aligned with the outermost periphery of neck opening (512). Upper and lower front panels (520, 540) are similarly tapered in the same manner, as is outer panel (552) (hence, the width of the pocket (P) tapers as well, being narrowest at the bottom of the pocket). Of course this arrangement is merely exemplary, as the side and front panels may be non tapered, or provided in a myriad of alternative styles (e.g., garment (710) in FIGS. 22-24, wherein the front panels, and hence the garment pocket, are generally of constant width along their length).
Outer panel (552) is provided on the front of garment (510), generally centered across the front width of the garment, and provides the pocket (P) between the inner surface of outer panel (552) and the outer surface of upper and lower front panels (520, 540). Outer panel (552) is affixed (e.g., by stitching) to upper and lower front panels (520, 540) along at least a portion of the right side (553A) of outer panel (552), and to lower front panel (540) along the lower end (554) of outer panel (552). In the particular embodiment shown, and as best seen in FIG. 14, outer panel (552), upper and lower front panels (520, 540) and right side panel (560A) are affixed to one another along a common seam (564) which extends from the bottom edge (513) to the upper ends of right side panel (560A) and upper front panel (520). Of course alternative arrangements are contemplated.
It should be noted that any of a variety of stitching patterns and techniques may be used for not only affixing the fabric panels to one another, but also to provide reinforcement of fabric edges and other commonly employed garment features and a cosmetically pleasing appearance. For example, as best seen in FIG. 17, edges of fabric panels such as the lower edge (522) of upper front panel (520) and the upper edge (542) of lower front panel (540) may be formed using a stitched turn back facing (or cuff) in order to not only provide a more aesthetically pleasing appearance but also to prevent fraying of the fabric. In the embodiment shown in FIGS. 10-20, the lowermost end of left side (553B) of outer panel (552) is affixed to lower front panel (540) using a box X stitch (555) in order to prevent detachment of outer panel (552) from lower front panel (540) from repeated opening and/or stress from opening of the garment pocket. Of course other techniques known to those skilled in the art may be used for the same purpose, such as various stitching patterns or the addition of other reinforcement (or this feature may be omitted entirely).
The upper end (556) and the majority of the length of left side (553B) of outer panel (552) are not affixed to the front panels (520, 540) or the side panels (560A, 560B). Instead, and as further described herein, the upper end (556) is adapted for releasable attachment to the upper front panel (520), and the left side (553B) of outer panel (552) is similarly adapted for releasable attachment to the upper and lower front panels (520, 540). In this manner, and as best seen in FIGS. 13 and 15, the upper left corner of outer panel (552) may be pulled downwardly away from the front of the garment (510) in order to open and allow access to the interior of the pocket (P) as well as to access opening (570) and anchor (586).
FIGS. 13 and 15 depict garment (510) with the pocket (P) opened. The pocket (P) is opened by simply pulling the upper left corner of outer panel (552) downwardly so as to detach the upper end portion (552) and left side portion (553B) of outer panel (552) from the upper and lower front panels (520, 540). A variety of fasteners may be used for the releasable attachment of outer panel (552), including conventional buttons (and corresponding button holes or loops), hook and bar fasteners, hook and loop fasteners (e.g., Velcro® brand), mating snaps and in other ways known to those skilled in the art. In some embodiments, the fasteners are of non-metallic construction (e.g., plastic) so that the garment is MRI-compatible. In the embodiment shown, male and female snaps are used for releasable attachment of the outer panel (552) to the upper and lower front panels (520, 540).
Male snaps (557) are provided on the inner surface of outer panel (552), along the upper and left side edges (552, 553B) thereof. While snaps (557) may be secured to outer panel (552) in a variety of ways, in the depicted embodiment male snaps (557) are provided on strips of snap tape (558) which are secured (e.g., stitched) to the inner surface of outer panel (552). Mating female snaps (530) are provided on upper and lower front panels (520, 540), provided on strips of snap tape (531, 545) secured (e.g., stitched) to the upper and lower front panels (520, 540), respectively. A first strip of snap tape (531A) extends across the width of upper front panel (520), spaced upwardly away from the lower edge (522) of upper front panel (520). A second strip of snap tape (531B) extends downwardly from first strip (531A), generally parallel to, but spaced inwardly from the left side edge (524B) of upper front panel (520). In the embodiment shown, second strip of snap tape (531B) is spaced inwardly from the left side edge (524B) by a distance slightly greater than the width of the snap tape. A third strip of snap tape (545) extends downwardly from the upper edge (542) of lower front panel (540), generally parallel to, but spaced inwardly from the left side edge (544B) of lower front panel (540). Once again the third strip of snap tape (545) is spaced inwardly from the left side edge (544B) by a distance slightly greater than the width of the snap tape. As before, snap tape (531, 545) may be affixed to the front panels in a variety of ways, such as by stitching. In addition, the snap tape, and hence the female snaps (530) thereon, are arranged to align with the male snaps (557) on outer panel (552) such that the outer panel may be releasably attached to the front panels (520, 540) by the mating engagement of the male and female slaps.
One benefit of embodiments wherein the outer panel (552) is releasably attached to the upper and lower front panels by mating snaps is that the spacing between snaps may be selected such that, when the pocket (P) is closed, sufficient space is provided between adjacent pairs of snaps to allow catheter tubing (or other medical device conduits such as electrical leads) to exit the pocket between adjacent pairs of engaged snaps. This feature is best seen, for example, in FIGS. 10 and 13. In this manner, garment (510) can be worn by a patient, with the pocket closed, even while the catheter tubing is being used to, for example, deliver medication to the patient (as shown in FIG. 10). Thus, in some embodiments at least two adjacent pairs of snaps used to close the pocket have a spacing (center of snap to center of adjacent snap) of at least about 1 inch, or at least about 1.5 inches. In some embodiments, the same snap spacing is used between all adjacent pairs of snaps on the outer panel (552) in order to provide a plurality of locations at which catheter tubing can be exit the pocket when the pocket is closed such as in FIG. 10.
FIGS. 16 and 17 depict garment (510) with the upper front panel (520) opened (FIG. 16) and both the upper and lower front panels (520, 540) opened (FIG. 17). As long as the pocket (P) is first opened in the manner depicted in FIG. 15, upper and lower front panels (520, 540) may be selectively and individually opened as desired. Thus, while access opening (570) can be used to, for example, access and visualize the exit wound of a central venous catheter, the upper and lower front panels may be opened to provide greater access to the chest region of a wearer (by opening upper front panel (520)) or to provide access to the abdominal region of a wearer (by opening lower front panel (540)), without the need to remove the garment or detach catheter tubing or other underlying medical devices. For example, a patient wearing garment (510) may continue to receive medication through a central venous catheter while one or both of the upper and lower front panel (520, 540) are opened to provide access to the patient's chest or abdomen, or even to remove the garment entirely.
Upper and lower front panels (520, 540) are opened by simply pulling the panel from left to right across the front of a wearer. Once again, a variety of fasteners may be used for the releasable attachment of front panels (520, 540) to left side panel (560A) and the left shoulder portion of back panel (580), including conventional buttons (and corresponding button holes or loops), hook and bar fasteners, hook and loop fasteners (e.g., Velcro® brand), and mating snaps. In the embodiment shown, male and female snaps are once again used for releasable attachment of the front panels (520, 540), particularly non-metallic snaps so that the garment is MRI-compatible.
In the exemplary embodiment shown, male snaps (557) are provided on the inner surface of upper and lower front panels (520, 540), immediately adjacent the left side edges (524B, 544B) thereof. In the depicted embodiment male snaps (557) are provided on strips of snap tape (532) which are secured (e.g., stitched) to the inner surfaces of upper and lower front panels (520, 540), along the left sides thereof.
Mating female snaps (530) are provided on the outer surface of left side panel (560B), adjacent inner side edge (563B) thereof. Female snaps (530) are once again depicted as being provided on strips of snap tape (561) secured (e.g., stitched) to the left side panel (560B). A first strip of snap tape (561A) extends downwardly from the upper end of left side panel (560B), generally along the inner side edge (563B) to a point adjacent the vertical location of the access opening (i.e., the location of the lower edge (522) of upper front panel (520) when the upper front panel is in the closed position, e.g., FIG. 15). A second strip of snap tape (561B) extends upwardly from the lower end of left side panel (560B), generally along the inner side edge (563B) to a point adjacent the vertical location of the access opening (i.e., the location of the upper edge (542) of lower front panel (540) when the lower front panel is in the closed position, e.g., FIG. 15). Two separate strips of snap tape (561A, 561B) are employed in the embodiment shown so that the spacing between the lowermost snap of upper snap tape (561A) and the uppermost snap of lower snap tape (561B) is smaller than the spacing between adjacent snaps on the same strip of snap tape (e.g., less than one half the distance) in order to allow a corresponding mating snap to be provided at the lower and upper ends of the upper and lower front panels (520, 540). As before, snap tape (561) may be affixed to the left side panel in a variety of ways, such as by stitching. In addition, the snap tape, and hence the female snaps (530) thereon, are arranged to align with the male snaps (557) on upper and lower front panels (520, 540) such that the front panels may be releasably attached to the left side panel (560B).
A pair of rearwardly-facing male snaps (534) are also provided along the left upper end (525B) of upper front panel (520), as shown. A fabric strip (575) is affixed to the left shoulder portion (581B) of back panel (580) which extends over the left shoulder area of the garment. In the example shown, fabric strip (575) also includes a small piece of binding at neck opening (512). Forward-facing female snaps (574) are provided on fabric strip (575), as shown, and are arranged to align with the male snaps (534) such that left upper end (525B) of upper front panel (520) may be releasably attached to the left shoulder portion (581B) of back panel (580).
It will be understood that, not only may alternative fasteners besides male and female snaps be used for releasably attaching certain fabric panels to one another, the arrangement of male and female snaps may be changed, such as by providing male snaps on left side panel (560B) and mating female snaps on the rear surface of upper and lower front panels (520, 540).
One or more retention members are provided on the garment (510) for releasably retaining a portion of the medical device (e.g., catheter tubing or other conduit such as electrical leads) at a selected location on the outside of the garment. A variety of retention members may be employed, depending in part on the nature of the medical device desired to be retained as well as the configuration of the garment. For garments configured to be worn by infants and toddlers, for example, it may be desirable to provide one or more retention members on the back of the garment, out of reach of the child. For older children and adults, on the other hand, one or more retention members may be provided elsewhere on the garment for retaining a portion of a medical device extending from the garment pocket so that the portion of the medical device is less likely to interfere with daily activities of the wearer and/or to facilitate use of the medical device.
For example, in the case of a central venous catheter wherein the catheter tubing extends out of the garment pocket (P) between adjacent pairs of snaps (or other fasteners), not only is it desirable to retain the catheter tubing in a convenient, out-of-the-way location for attachment to an infusion pump, but also to locate the catheter tubing so that it is less likely to interfere with daily activities and less likely to be tugged upon or otherwise pulled (e.g., by snagging on something).
In the example garment (510) shown in FIGS. 10-20, a pair of retention members are provided on each shoulder of the garment. In particular, a retention member comprising a shoulder strap (583) is provided on each shoulder of garment (510), located over left and right shoulder portions (581A, 581B) of back panel (580). Shoulder straps (583) are affixed at their inner ends at neck opening (512), while their outer ends have a snap (584) which is matingly engageable with a snap (585) provided on the right and left shoulder portions (581A, 581B) of back panel (580), as shown. As best seen in FIG. 18, snap (585) is provided on a strip of snap tape affixed (e.g., stitched) to the shoulder portion (581A, 581B) of the back panel (580). The use of snap tape provides additional reinforcement, particularly when the back panel (580) comprises a mesh material or other breathable fabric which may be more prone to fail after prolonged use (as compared to the material used for the front and/or side panels).
As best seen in FIG. 18, the outer end portion of shoulder strap (583) is selectively detachable from the shoulder portion (581A, 581B) of back panel (580). This allows the retention member provided by shoulder strap (583) to be opened so that catheter tubing (T) (or other conduit or portion of a medical device) may be draped over the wearer's shoulder. Thereafter, the shoulder strap (583) is snapped back in place such that the tubing (T) is retained beneath the shoulder strap (see FIG. 10). As discussed further herein, a similar retention member may be provided on the back of the garment for retaining a portion of a medical device (e.g., catheter tubing) against the back surface of the garment.
Shoulder straps (583) may be made of a variety of materials, particularly elastic (i.e., stretchable) fabrics such as woven, braided or knitted natural and synthetic fibers combined with an elastic material such as latex or rubber. In the example, shown shoulder straps (583) comprise braided polyester with latex or rubber for elasticity. By using an elastic material, shoulder straps (583) more securely retain catheter tubing (or other portions of a medical device) against the patient's shoulder in order to provide strain relief which, for example, prevents tugging or pulling on the exit wound of the catheter or which might otherwise cause a medical device conduit (e.g., electrical leads) to be disconnected from the patient or medical device unit. Shoulder straps (583) are also useful in maintaining the catheter tubing out of the way, particularly when the patient is in a supine or inclined position (e.g., for overnight infusion).
Like previously described embodiments, medical garment (510) of FIGS. 10-20 also includes a tubing anchor (586) located within the pocket (P). Tubing anchor (586) may be configured like any of the previously-described anchor embodiments, and secured within the pocket by any of the variety of ways described previously (e.g., using an adhesive). In the embodiment shown in FIGS. 10-20, anchor (586) is removably secured within the garment pocket such that the anchor may be removed when not needed and/or replaced with a new or different tubing anchor, as necessary. For example, anchor (586) may be replaced if worn or dirty, or may be replaced with a different type or size of anchor to accommodate, for example, different sizes of catheter tubing or a different type of conduit (e.g., an anchor sized with a smaller opening and/or greater clamping force for purposes of securing electrical leads rather than catheter tubing).
Securement of anchor (586) within the pocket may be provided in a variety of ways, such as by using an adhesive, or using a hook and loop fastener arrangement wherein one of the hook or loop elements is affixed to the surface of one of the fabric panels within the pocket and the other is affixed to the tubing anchor (e.g., in place of adhesive (43) on anchor (40) in FIG. 5). As yet another alternative, mechanical fasteners such as hook and bar fasteners or mating snaps may be employed (e.g., as shown in FIGS. 26 and 27). In the latter embodiment, one or more male or female snaps are provided on a surface of one of the fabric panels within the pocket, and one or more mating female or male snaps are provided on the tubing anchor such that the tubing anchor may be snapped in place within the pocket (P) and easily removed therefrom, as desired.
The garment may also be configured to allow the tubing anchor to be removably secured within pocket (P) at more than one location. For example, when a snap fastening system is employed, snaps may be provided at two or more locations within the pocket (P), such as a snap (or set of snaps) located on upper front panel (520) above access opening (570) and a snap (or set of snaps) located on lower front panel (540) below access opening (570). Such an arrangement is shown in FIGS. 26 and 27, and further described herein.
In the embodiment of FIGS. 10-20, and as best seen in FIGS. 19, 20A and 20B, anchor (586) is similar to anchor (440) described previously herein, and comprises a clamshell assembly adapted for clamping securement of a catheter or other conduit between adjacent portions of the clamshell assembly. Anchor (586) is configured to clampingly secure the catheter tubing between a base portion (587) and a clamping portion (588) without exerting so much clamping pressure that the internal lumen of the catheter tubing is closed or reduced in diameter. Thus, as seen in FIGS. 20A and 20B, tubing anchor (586) includes a base member (587) and a closure (or clamping) member (588) which pivotally extends from the base member through a hinge segment (589). A compressible lining (or tubing retainer) (592) lines the interior of the tubing anchor between base member (587) and closure member (588), with an upper layer (592A) of compressible lining positioned against closure member (588) and a lower layer (592B) positioned against base member (587), such that tubing may be received between the upper and lower layers of the compressible lining (592) and held therebetween. Alternatively, only one layer of compressible lining may be provided in the anchor.
Tubing anchor (586) may be configured like tubing anchor (440) described previously so as to include mating fastening features for selectively maintaining the tubing anchor in a closed position (e.g., FIGS. 9C and 9D). Alternatively, and as shown in FIGS. 20A and 20B, hinge segment (589) of tubing anchor (586) is sufficiently rigid and biased to the closed position shown in FIG. 20A such that the fastening features used on anchor (440) are not necessary. Instead, an upturned end wall (590) is provided opposite hinge segment (589), as shown, merely to aid in retaining catheter tubing within anchor (586). In order to insert catheter tubing (or other medical device conduit) into tubing anchor (586), the end of closure member (588) adjacent end wall (590) is urged upwardly such that closure member (588) pivots away from base member (587) (similar to the depiction in FIG. 9A for tubing anchor (440)). With the tubing anchor (586) held in the open position, catheter tubing is slid between the upper and lower layers (592A, 592B) of the compressible lining. Once in position, the end of closure member (588) is released, allowing the tubing anchor to return to its closed position shown in FIG. 20A, with the catheter tubing secured within tubing anchor (586) by biasing of the based and clamping members towards one another, as shown in FIG. 19. The various anchors described herein can be provided in a variety of sizes in order to accommodate, for example, various sizes and number of catheter tubing. Also, the anchor can be designed to have a low profile with rounded edges for patient comfort.
Anchor (586) is secured within the pocket (P) by an anchor retainer. The anchor retainer in the exemplary embodiment comprises a sleeve (594) into which a portion of anchor (586) is inserted. In particular, sleeve (594) comprises a fabric loop (e.g., an elastic fabric such as that used for the shoulder straps) which is affixed to a panel of the garment within the pocket (P). In the exemplary embodiment, as best seen in FIGS. 19 and 20, sleeve (594) is affixed to lower front panel (540) adjacent the upper edge (542) of lower front panel (540) (i.e., slightly below access opening (570)). An anchor receiving chamber (595) is provided by the fabric loop of sleeve (594) (see FIG. 20B), and the anchor receiving chamber (595) extends across a portion of the lower front panel (540) generally parallel to the outer surface of the lower front panel. As noted below, this arrangement, as well as the height at which sleeve (594) is secured within the pocket (P), properly orients the anchor with respect to the access opening.
In order to secure tubing anchor (586) using the anchor retaining sleeve (594), the base member (587) of tubing anchor (586) is inserted into the anchor receiving chamber (595) such that the upper end portion of retaining sleeve (594) is positioned between the lower layer (592B) of the compressible lining and base member (587), as shown. The fit of base member (587) within anchor receiving chamber (595) is snug, with little or no vertical movement of the anchor and permitting only so much horizontal movement of the anchor as necessary for anchor installation and alignment. The snug fit helps to ensure that the anchor (586) will remain in its desired position and orientation, with the snug fit aided by using an elastic fabric for retaining sleeve (594).
Because anchor receiving chamber (595) extends generally parallel to the access opening (570) and is configured to locate the tubing anchor (586) adjacent the access opening (570), catheter tubing is able to pass through the access opening (570) directly into tubing anchor (586) between upper and lower layers (592A, 592B) of the compressible lining without the need for abrupt changes in direction of the tubing which might pinch or otherwise close off the tubing. In the exemplary embodiment shown, tubing anchor (586) and retaining sleeve (594) are configured such that the tubing-receiving region between the upper and lower layers (592A, 592B) of the compressible lining is positioned at or slightly below the vertical height of the access opening (570), such as less than 2 inches, or less than 1 inch below access opening (570). In addition, the entrance (E) (see FIG. 20B) to the tubing-receiving region between the base and clamping members (between the compressible lining layers, when used) is positioned immediately adjacent to the access opening (570), with the width of the tubing-receiving region extending orthogonal to the front surface of the garment. This arrangement further facilitates insertion of the catheter tubing into the anchor.
Of course it will be understood that retaining sleeve (594) (or other anchor retainer) may be located at a variety of other locations within the pocket (P), such as being affixed to upper front panel (520) (see FIG. 28) or to lower front panel (540) at a location further below access opening (570). In some alternative embodiments, more than one anchor retainer may be provided within the pocket, such as one retaining sleeve affixed to the upper front panel above access opening (570), and a second retaining sleeve affixed to the lower front panel below access opening (570), as shown in the alternative embodiment of FIG. 25. It is also contemplated that the anchor (586) may be modified so as to have only a single upper layers of compressible lining (592A) such that catheter tubing positioned within the anchor will be held between the upper lining layer (592A) and the upper outer surface of the retaining sleeve (594).
The use of garment (510) will now be described, with specific reference to a patient who already has a central venous catheter (C) in place in their upper chest region along with a plurality of catheter tubes (T) extending away from the external hub of the catheter (see FIGS. 11 and 13). Of course a similar procedure is followed when the garment is to be used with other medical devices, such as a Holter monitor wherein the electrical leads are positioned similar to the catheter tubing and the Holter unit itself stored within the pocket of the garment.
With the garment (510) opened as in FIG. 17, the patient's arms are inserted into right and left arm openings (514), with the inner surface of back panel (580) against the patient's back. Lower front panel (540) is then snapped closed, as shown in FIG. 16. Next, the catheter tubing is positioned such that it extends downwardly past the lower edge (522) of upper front panel (520), and either draped over lower front panel (540) or inserted into the lower portion of pocket (P). The upper front panel (520) is then snapped closed (e.g., FIG. 15). Because the lower edge (522) of upper front panel (520) and upper edge (542) of lower front panel (540) are not affixed to one another, the catheter tubing will extend through access opening (570) provided between lower edge (522) and upper edge (542).
Next, the catheter tubing is positioned within the tubing anchor (586) in the manner described previously. If use of the catheter tubing is not necessary at that time, the catheter tubing extending from tubing anchor (586) is merely inserted into the pocket (P) such as by coiling the tubing in the manner depicted in FIG. 11. The outer panel (522) is then snapped closed with the catheter tubing stowed within the pocket (P). The garment itself (i.e., the rear, skin-facing surface of upper front panel (520)) helps to limit movement of the external portion of the central venous catheter by applying a gentle compressive force against the catheter. Similarly, the tubing anchor will also hold the catheter tubing in place, with the pocket further protecting the catheter tubing and preventing any pulling force from being applied to the tubing (whether inadvertently or from an infant or toddler pulling on the catheter tubing). The pocket also bears the weight of any catheter tubing (or other portion of a medical device) stored therein, thus providing additional strain relief. In this manner, the garment (510) prevents pulling, dislodgement, breakage or other interference with the central venous catheter and tubing during normal daily activities or during sleep, thereby helping to reduce pain, inflammation, infection, and/or reduced catheter performance due to damaged tubing, breakage, catheter dislodgement and the like. Storing the catheter tubing out of sight, within the pocket (P), not only aids in keeping the catheter tubing clean and safe, but also provide psychological benefit for some patients, since many, particularly children, can be embarrassed or otherwise uncomfortable if the catheter tubing is visible.
If use of the catheter tubing is necessary such as for the infusion of medication through the central venous catheter, the pocket is opened and the catheter tubing removed from the pocket (or at least as much as is necessary for infusion purposes). If desired, the tubing may be draped over one shoulder, beneath a shoulder strap (583), in order to maintain the tubing in a desired, out-of-the-way position, so as to minimize interference with, for example, other activities of the patient during infusion. Holding the tubing in a desired position using a shoulder strap (583) is also advantageous for infusion while the patient is sleeping, helping to avoid the tubing becoming entangled with the patient or other apparatus should the patient move.
FIG. 21 depicts an alternative embodiment of a medical garment (610). Garment (610) is constructed similar to garment (510), with the only difference being the length and depth of the pocket. In the embodiment shown in FIGS. 10-20, outer panel (552) extends downwardly from a point at or slightly above the lowermost end of arm openings (514) to approximately the middle of lower front panel (540) (i.e., the distance from access opening (570) to the bottom edge of outer panel (552) is about one half of the length of lower front panel (540)). In the embodiment shown in FIG. 21, on the other hand, outer panel (652) extends downwardly to nearly the bottom edge (613) of the garment (610) (e.g., less than 2 inches, or even less than one inch from bottom edge (613)). In this manner, a significantly deeper (and larger) pocket is provided. In the example shown, box X stitch (655), like the previous embodiment, indicates the extent of the releasable attachment of outer panel (652) to lower front panel (640), such that outer panel (652) is permanently affixed (e.g., by stitching) to lower front panel (640) below box X stitch (655), along the left side of the outer panel.
Of course the length, depth and width of the pocket may be altered, as desired. For example, the garment may be configured such that the pocket extends from adjacent the neck opening all the way to the bottom edge of the garment (i.e., the waist opening of the garment). Similarly, the relative lengths of the upper and lower front panels (e.g., 520, 540) may be varied in order to alter the vertical location of the access opening.
For example, in some embodiments the pocket extends at least about 25% of the length of the garment (measured from shoulder, at neck opening (512), to bottom edge (513)), in other embodiments about 30-70% of the length of the garment, and in still other embodiments about 35-60% of the length of the garment. The vertical location of the access opening in some embodiments is below the arm openings (514), and in some embodiments within the upper half of the pocket. In still further embodiments, the vertical location of the access opening is between the lowermost extent of the arm openings (514) and the vertical center of the garment.
FIGS. 22-24 depict yet another alternative embodiment of a medical garment (710), in this case configured to be worn by an infant. Garment (710) is constructed similar to garment (510), and includes upper and lower front panels (720, 740), side panels (760A, 760B), a back panel (780), an outer panel (752), and a neck opening (712). Garment (710) also includes right and left sleeves (714). As with medical garment (510), an access opening (720) is provided between the adjacent lower edge of upper front panel (720) and the upper edge of lower front panel (740). A pocket (P2) is provided between outer panel (752) and the front panels (720, 740), and an anchor (786) is located within the pocket.
Instead of being configured as a shirt, however, garment (710) is configured as an infant or toddler bodysuit which covers the upper torso and at least a portion of the lower torso. In the embodiment shown in FIGS. 22-24, the garment (710) is configured such that right and left leg cuffs (715A, 715B) encircle an infant's legs adjacent the crotch area such that the garment has no pant legs. Garment (710) includes right and left leg cuffs (715A, 715B) formed by the lower front panel (740) and the back panel (780). In particular, lower front panel (740) includes a lower portion (741) which, when the garment (710) is placed on an infant, extends over the front crotch area. Lower portion (741) of lower front panel (740) terminates at right and left leg cuffs (715A, 715B), and center cuff located therebetween (not shown). The back panel (780) includes a center flap (716) arranged to extend over the buttocks area of an infant and over a portion of the front crotch area over a part of lower portion (741) of lower front panel (740). Snaps (717) (or other suitable fasteners) are provided on center flap (716) and are arranged to mate with, and fasten to, corresponding snaps (not shown) on the lower portion (741) of lower front panel (740).
Like garment (510), garment (710) also includes a pair of retention members on each shoulder of the garment, wherein the retention members comprise shoulder straps (783) which are constructed similar to shoulder straps (583) previously described. As seen in FIG. 24, garment (710) further includes a rear retention strap (778) on the back panel (780). Retention strap (778) is constructed similar to shoulder straps (583, 783), and thus comprises a strip of elastic fabric that is affixed at one end to the back panel (780), while the other end has a snap (779) which is matingly engageable with a snap (not shown) provided on back panel (780). Thus, the snap end of rear retention strap (778) is selectively detachable from the back panel (780) so that rear retention strap (778) can be used to retain catheter tubing against the wearer's back in the same manner that shoulder straps (583, 783) may be used to retain catheter tubing and the like over a wearer's shoulder. Rear retention strap (778) thus not only maintains the catheter tubing (or other conduit) out of the way, it also makes it difficult to an infant or toddler to grab and pull the tubing.
FIG. 25 depicts another alternative embodiment, in this instance a medical garment system comprising a garment (810) in combination with a fabric bag (811). Garment (810) is constructed similar to medical garment (510), and thus includes upper and lower front panels, with an access opening (870) provided therebetween. A pocket is also provided, along with an anchor (886) secured within the pocket using an anchor retainer (894). The anchor retainer (894) comprises a sleeve similar to sleeve (594) described previously. In this embodiment, however, a pair of anchor retainers (894) are provided in the pocket—one secured to the upper front panel (820), and the other secured to the lower front panel (840). This provides two locations for positioning anchor (886). Of course any number of anchor retainers (894) may be provided within the pocket, as desired, such as three (or more) anchor retainers at various heights or other locations.
In addition to access opening (870) provided between the lower edge of upper front panel (820) and the upper edge of lower front panel (840), a second access opening is provided in order to provide an additional location for a portion of a medical device (e.g., catheter tubing or electrical leads) to pass from beneath the garment and into the pocket (P3). In this example, the second access opening comprises a slot (871) provided in lower front panel (840), spaced below access opening (870) and lowermost anchor retainer (894). Slot (871) is simply an opening cut in lower front panel (840), reinforced around its periphery by stitching. Unlike access opening (870), second access opening (871) does not extend across the full width of the pocket (P3), and may be located at any height within the pocket, or even on upper front panel (820) instead of lower front panel. Also, two or more second access openings (i.e., in addition to access opening (870)) may be provided, as desired.
Fabric bag (811) is also included in the medical garment system shown in FIG. 25, and is used in conjunction with the pocket (P3). Thus, fabric bag (811) is sized so as to fit into the pocket (P3), and may be used for providing a separate, removable compartment within the pocket (P3) for various portions of medical devices, cold or hot packs, or even personal items such as a phone. In some embodiments, bag (811) is made of an antimicrobial fabric—i.e., a fabric that is constructed of a material which inhibits, and/or treated so as to inhibit, microbial growth (e.g., bacteria and/or fungus). Thus, fabric bag (811) may be used to provide a more sanitary environment within the pocket (P3) for catheter tubing and the like, or to house personal items such as a phone within the pocket (P3) while helping to prevent the contents of bag (811) from contaminating catheter tubing or other medical devices also located within the pocket (P3). In addition, fabric bag (811) even provides a convenient way to carry items outside of the pocket (P3) when it is not necessary or desirable to store those items within the pocket of the garment.
FIGS. 26 and 27 depict yet another alternative embodiment of a medical garment (910) constructed similar to garment (510) of FIGS. 10-20. The principle difference between garment (910) and garment (510) is with respect to the anchor (986) and the manner in which the anchor is secured within the pocket (P4). Anchor (986) is a clamshell arrangement, and is constructed similar to anchor (440) shown in FIGS. 9A-C. Thus, anchor (986) includes a closure (or clamping) member (988) pivotally attached at one end to an end of a base member (987).
In the embodiment of FIGS. 26 and 27, the anchor retainers comprise mating male and female snaps provided within the pocket (P4) and on the anchor (986). The bottom surface of the base member (987) (i.e., corresponding to the garment attaching surface (443) of anchor (440) in FIG. 9B) is adapted for selectively and releasably securing the anchor (986) within the pocket (P4) of garment (910). In the particular embodiment shown in FIG. 27, a pair of male snaps (991) are located on the bottom surface of base member (987), spaced apart by a predetermined distance. First and second pairs of mating female snaps (994, 995) are provided on the upper and lower front panels (920, 940), respectively, with the snaps in each pair spaced apart by the same predetermined distance. Anchor (986) is selectively and releasably secured within the pocket (P4) by attaching the bottom surface of the anchor to one of the pairs of female snaps (994, 995). Thus, anchor (986) may be secured either to upper front panel (920) above access opening (970), or to lower front panel (940) below access opening (970). Alternatively, two anchors (986) may be simultaneously secured within pocket (P4) by using both pairs of anchors.
In addition, additional pairs of mating snaps may be provided at one or more further locations within the pocket (P4), particularly when the pocket includes one or more second access openings like that in garment (810). Also, like all of the other snap attachments described herein, the male/female snap locations can be reversed (e.g., male snaps on front panels and female snaps on anchor (986)).
FIG. 28 depicts another embodiment of a medical garment (1010) similar to garment (510), which includes not only a pocket (P5), but also at least one anchor (1086) located within the pocket (P5). In this instance, anchor (1086) is secured to upper front panel (1020) such as by using an anchor retainer comprising a sleeve similar to sleeve (594) described previously.
In the embodiment of FIG. 28, an access opening is once again provided between the upper and lower front panels (1020, 1040), with the upper and lower front panels not affixed directly to one another (other than, perhaps, their far right edges along the seam connecting the right side panel, outer panel and front panels). In the embodiment of FIG. 28, however, the upper and lower front panels (1020, 1040) overlap one another such that the lower edge (1022) of upper front panel (1020) is located below the upper edge (1042) of lower front panel (1040) (when the front panels are closed), with the access opening provided between the overlapping portions of the upper and lower front panels. In some embodiments, the overlap is about 2 inches or less, in other embodiments about 1 inch or less, and in still further embodiments about 0.5 inches or less.
Because of the overlap of upper and lower front panels (1020, 1040), an additional snap (1033) is provided on the outer surface of lower front panel (1040), at the upper left corner thereof. Snap (1033) is located and configured for mating engagement with the lowermost snap (1057) on the rear surface of upper front panel (1020). Of course it will be understood that the overlap of the front panels can be reversed such that lower front panel (1040) overlaps upper front panel (1020), with an additional snap provided on the outer surface of the upper front panel for mating engagement with the uppermost snap on the rear surface of the lower front panel.
The various garments described and depicted herein can be made from any of a variety of fabrics, including those made from synthetic and/or natural fibers. Also, the same or different materials may be used for the various fabric panels. For example, in garment (510), back panel (580) comprises a mesh fabric, while the other panels (e.g., front, side and outer panels) comprise a jersey knit fabric. The mesh and jersey knit fabrics are moisture wicking, and are optionally antimicrobial (by choice of material and/or by treatment process). Alternatively, garment may be configured such that only selected portions are antimicrobial. For example, the fabric within the pocket (e.g., the upper and lower front panels and the outer panel) are antimicrobial, while other fabric panels are not.
While several devices and components thereof have been discussed in detail above, it should be understood that the components, features, configurations, and methods of using the devices discussed are not limited to the contexts provided above. In particular, components, features, configurations, and methods of use described in the context of one of the devices may be incorporated into any of the other devices. Furthermore, not limited to the further description provided below, additional and alternative suitable components, features, configurations, and methods of using the devices, as well as various ways in which the teachings herein may be combined and interchanged, will be apparent to those of ordinary skill in the art in view of the teachings herein.
By way of example, one modification of the garment shown in FIGS. 10-20 is to alter the location of the access opening (570) in order to better accommodate alternative catheter entry locations. For example, multi-lumen catheters typically used for therapeutic apheresis typically enter the patient higher than is shown in FIG. 11, adjacent the clavicle. Thus, it is contemplated that garment (510) can be modified such that the access opening (570) is located higher than is depicted in FIGS. 10-20. That can be accomplished, for example, by shortening the length of the upper front panel (520) and lengthening lower front panel (540) such that the access opening (570) will be located adjacent the patient's clavicle. Accordingly, the pocket will similarly be located higher on garment (510), such that, when the pocket is closed, the upper end (556) of outer panel (552) is located just below neck opening (512) (e.g., less than 3 inches from the neck opening).
Alternatively, the garment may be modified such that the access opening for an apheresis catheter comprises a slot (also referred to herein as a slit, particularly when formed by a single cut in a panel) formed in one of the front panels (520, 540) similar to slot (871) in FIG. 25. Such a slot may be in addition to an access opening provided between upper and lower front panels (similar to FIG. 25), or may be in place of such an access opening (in which case a unitary front panel can be used, with the slot formed in, and extending across a portion of the width of the front panel). Like the previously described embodiments, an anchor is once again provided in the pocket adjacent the slot.
As yet another alternative, the outer panel, and hence the pocket and internal slit and anchor, can be located elsewhere on the garment besides being centered across the front width of the garment. For example, the outer panel forming the pocket may comprise a rectangular panel similar to that found on a conventional shirt, located adjacent the right and/or left clavicle region (e.g., less than about 5, or even 4, inches in height and less than about 4, or even 3, inches in width, positioned lateral to the front centerline of the garment). As yet another alternative, the outer panel forming the pocket may even be located on one or both sleeves of the garment in order to accommodate, for example, a PICC line.
Having shown and described various versions in the present disclosure, further adaptations of the methods and systems described herein may be accomplished by appropriate modifications by one of ordinary skill in the art without departing from the scope of the present invention. Several of such potential modifications have been mentioned, and others will be apparent to those skilled in the art. For instance, the examples, versions, geometrics, materials, dimensions, ratios, steps, and the like discussed above are illustrative and are not required. Accordingly, the scope of the present invention should be considered in terms of the following claims and is understood not to be limited to the details of structure and operation shown and described in the specification and drawings.

Claims

What is claimed is:

1. A medical garment adapted to be worn by a patient, comprising:

(a) a body portion adapted to be worn on at least the upper torso of a patient, said body portion comprising at least one front panel having an outward-facing surface and an inward-facing, skin-contacting surface;

(b) an access opening extending across at least a portion of the body portion of the garment, wherein the access opening provides communicates between the outward- and inward-facing surfaces of the front panel;

(c) a pocket-forming outer panel affixed to the body portion of the garment such that a selectively-closeable pocket is provided between at least a portion of the front panel and the pocket-forming panel, the pocket extending downwardly from said access opening; and

(d) a medical device anchor secured within said pocket, said anchor adapted for releasable securement of a portion of a medical device within said pocket.

2. The medical garment of claim 1, wherein said anchor is removably secured within said pocket.

3. The medical garment of claim 2, wherein said anchor comprises a clamshell assembly adapted for clamping securement of a conduit of a medical device between adjacent portions of the clamshell assembly.

4. The medical garment of claim 3, further comprising at least one retention member adapted for releasably retaining a portion of a medical device at a predetermined location on an outer surface of the garment.

5. The medical garment of claim 4, wherein said at least one retention member comprises a retention strap secured to a shoulder portion of rear surface of the garment.

6. The medical garment of claim 1, wherein said at least one front panel comprises an upper front panel having a lower edge and a lower front panel having an upper edge adjacent the lower edge of the upper front panel, each of said upper and lower front panels having an outward-facing surface and an inward-facing skin-contacting surface, wherein said access opening is located between the upper and lower front panels.

7. The medical garment of claim 6, wherein said access opening is provided between the lower edge of the upper front panel and the upper edge of the lower front panel.

8. The medical garment of claim 6, wherein said anchor is removably secured to the outward-facing surface one of said upper and lower front panels, within said pocket.

9. The medical garment of claim 8, wherein said access opening extends horizontally across the entire width of said pocket.

10. The medical garment of claim 9, wherein said outer panel comprises upper and lower ends and first and second sides extending along either side of the outer panel, said outer panel affixed to the body portion of the garment along at least a first side and the lower end of the outer panel, and releasably attached along its upper end and at least a portion of its second side such that said pocket is selectively closeable.

11. The medical garment of claim 10, wherein said outer panel is releasably attached along its upper end to said upper front panel, and is releasably attached along a portion of its second side to said upper front panel and said lower front panel.

12. The medical garment of claim 8, wherein said anchor is removably secured within said pocket by an anchor retaining sleeve adapted to receive a portion of said anchor.

13. A medical garment adapted to be worn by a patient, comprising:

(b) an access opening extending horizontally across at least a portion of the body portion of the garment, wherein the access opening provides communicates between the outward- and inward-facing surfaces of the front panel;

(c) a pocket-forming outer panel affixed to the body portion of the garment such that a selectively-closeable pocket is provided between at least a portion of the front panel and the outer panel, the pocket extending downwardly from said access opening; and

(d) at least one medical device anchor adapted for removable securement to the outward-facing surface of said at least one front panel such that the anchor is concealed behind said outer panel when the pocket is closed, said anchor adapted for releasable securement of a conduit of a medical device within said pocket.

14. The medical garment of claim 13, wherein said front panel and said anchor are configured such that the anchor is removably securable to the outward-facing surface of said front panel at a plurality of predetermined locations.

15. The medical garment of claim 13, further comprising a second access opening communicating between the interior and exterior of the garment.

16. The medical garment of claim 13, wherein said anchor comprises a clamshell assembly having a base portion and a clamping portion, the anchor adapted for clampingly securing a conduit of a medical device between said base portion and said clamping portion.

17. The medical garment of claim 13, wherein said at least one front panel comprises an upper front panel having a lower edge and a lower front panel having an upper edge adjacent, but not affixed to the lower edge of the upper front panel, wherein said access opening is located between the upper and lower front panels.

18. The medical garment of claim 17, wherein said upper and lower front panels are selectively and separately openable along one side thereof such that the opening of one of said front panels also opens said access opening, thereby allowing the garment to be removed from a patient without disconnecting a conduit of a medical device which extends from the patient through said access opening.

19. The medical garment of claim 18, wherein said outer panel comprises upper and lower ends and first and second sides extending along either side of the outer panel, said outer panel affixed to the body portion of the garment along at least a portion of a first side and the lower end of the outer panel, and releasably attached along at least a portion of its upper end and at least a portion of its second side such that said pocket is selectively closeable, wherein said outer panel is releasably attached along its upper end to said upper front panel, and is releasably attached along a portion of its second side to said upper front panel and said lower front panel.

20. The medical garment of claim 19, wherein the entirety of said garment is non-metallic.