US20170055967A1 - Scope-Mounted iNod Handle - Google Patents
Scope-Mounted iNod Handle Download PDFInfo
- Publication number
- US20170055967A1 US20170055967A1 US15/250,478 US201615250478A US2017055967A1 US 20170055967 A1 US20170055967 A1 US 20170055967A1 US 201615250478 A US201615250478 A US 201615250478A US 2017055967 A1 US2017055967 A1 US 2017055967A1
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- Prior art keywords
- distal
- proximal
- needle
- sheath
- central portion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
- 239000000523 sample Substances 0.000 claims description 28
- 238000002604 ultrasonography Methods 0.000 claims description 26
- 238000000034 method Methods 0.000 claims description 12
- 210000003813 thumb Anatomy 0.000 claims description 12
- 238000003780 insertion Methods 0.000 claims description 10
- 230000037431 insertion Effects 0.000 claims description 10
- 238000005070 sampling Methods 0.000 claims description 8
- 230000007246 mechanism Effects 0.000 claims description 4
- 238000012800 visualization Methods 0.000 claims description 4
- 238000001574 biopsy Methods 0.000 description 4
- 210000004072 lung Anatomy 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 210000000481 breast Anatomy 0.000 description 1
- 238000004891 communication Methods 0.000 description 1
- 238000003745 diagnosis Methods 0.000 description 1
- 238000009558 endoscopic ultrasound Methods 0.000 description 1
- 238000001839 endoscopy Methods 0.000 description 1
- 210000004185 liver Anatomy 0.000 description 1
- 210000003437 trachea Anatomy 0.000 description 1
Images
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/04—Endoscopic instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00064—Constructional details of the endoscope body
- A61B1/00066—Proximal part of endoscope body, e.g. handles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/00112—Connection or coupling means
- A61B1/00121—Connectors, fasteners and adapters, e.g. on the endoscope handle
- A61B1/00128—Connectors, fasteners and adapters, e.g. on the endoscope handle mechanical, e.g. for tubes or pipes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B1/00—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor
- A61B1/012—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor
- A61B1/018—Instruments for performing medical examinations of the interior of cavities or tubes of the body by visual or photographical inspection, e.g. endoscopes; Illuminating arrangements therefor characterised by internal passages or accessories therefor for receiving instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0266—Pointed or sharp biopsy instruments means for severing sample
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/0233—Pointed or sharp biopsy instruments
- A61B10/0283—Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B2010/0208—Biopsy devices with actuators, e.g. with triggered spring mechanisms
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
- A61B10/02—Instruments for taking cell samples or for biopsy
- A61B10/04—Endoscopic instruments
- A61B2010/045—Needles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3405—Needle locating or guiding means using mechanical guide means
- A61B2017/3409—Needle locating or guiding means using mechanical guide means including needle or instrument drives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/34—Trocars; Puncturing needles
- A61B17/3403—Needle locating or guiding means
- A61B2017/3413—Needle locating or guiding means guided by ultrasound
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
- A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
- A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
- A61B8/445—Details of catheter construction
Definitions
- Biopsies may be performed with Endoscopic Ultrasound Fine Needle Aspiration (“EUS-FNA”) devices to obtain cells or small samples of tissue from, for example, the breast, liver or lung for cytology studies, endoscopy, oncology or bronchology.
- EUS-FNA Endoscopic Ultrasound Fine Needle Aspiration
- biopsy needles enable the capture of samples to facilitate diagnosis and treatment.
- These biopsy needles are generally connected at their proximal ends to handles to facilitate their insertion into target tissue.
- handles are typically formed as two or more overlapping substantially cylindrical elements with a first element attached to an endoscope and a second larger diameter element overlapping a proximal portion of the first element being used to advance the needle into a target site in a living body.
- the present disclosure is directed to a handle for a medical device, comprising a distal portion, a central portion and a proximal portion.
- the distal portion extending longitudinally from a proximal end to a distal end and including a distal channel extending therethrough, the distal end of the distal portion including a connector configured to connect to a proximal end of an endoscope.
- the central portion is sized and shaped to be slidably connected to the proximal end of the distal portion, the central portion extending longitudinally from a proximal end to a distal end and including a central channel (i.e., a channel located in the central portion) extending therethrough, the distal end of the central portion being configured to be connected to a sheath, the central portion including an introducer port extending laterally therefrom so that an auxiliary tool inserted through the introducer port is directed through a lumen of the sheath.
- a central channel i.e., a channel located in the central portion
- the proximal portion sized and shaped to be slidably connected to the proximal end of the central portion, the proximal portion extending longitudinally from a proximal end to a distal end and including a proximal channel extending therethrough, the distal end of the proximal portion being configured to be connected to a needle so that the needle is passed through the lumen of the sheath, the distal, central and proximal portions are longitudinally movable relative to one another to adjust a relative positioning between the endoscope, sheath and needle.
- the distal portion may include a longitudinal slot extending longitudinally from the proximal end thereof, the longitudinal slot sized and shaped to slidably receive the introducer port of the central portion therein.
- the distal portion may be a C-shaped tube.
- the proximal end of the proximal portion may include a connection mechanism configured to connect the needle to an aspirating source.
- the introducer port may include a locking feature for locking the auxiliary tool relative thereto.
- the locking feature may include one of a slot sized and shaped to wedge a portion of the auxiliary tool therein and a clamp configured to clamp the auxiliary tool to the introducer port.
- the handle may further comprise a locking element for locking the distal and central portions relative to one another.
- the locking element may include a thumb screw threadedly engaging a hole extending laterally through the distal portion so that, when in a locked configuration, an end of the thumb screw engages an exterior surface of the central portion.
- the handle may further comprise an adjustable needle stop configured to limit advancement of the needle relative to the sheath.
- the adjustable needle stop may include a collar slidably mounted over the proximal portion and a thumb screw threadedly engaging a hole extending laterally through the collar so that, when the thumb screw is tightened within the hole, the adjustable needle stop is fixed in a desired position along the proximal portion, a cross-sectional area of the collar being larger than a cross-sectional area of the central portion.
- the present disclosure is also directed to a tissue sampling device, comprising a handle member including a distal portion extending longitudinally from a proximal end to a distal end and including a distal channel extending therethrough, a central portion sized and shaped to be slidably connected to the proximal end of the distal portion, the central portion extending longitudinally from a proximal end to a distal end and including a central channel (i.e., a channel located in the central portion) extending therethrough along with an introducer port extending laterally therefrom, and a proximal portion sized and shaped to be slidably connected to the proximal end of the central portion, the proximal portion extending longitudinally from a proximal end to a distal end and including a proximal channel extending therethrough.
- a handle member including a distal portion extending longitudinally from a proximal end to a distal end and including a distal channel extending therethrough
- the device also comprises an endoscope connected to the distal portion via a connector at the distal end thereof, a sheath extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough, the proximal end of the sheath connected to a distal end of the central portion, and a needle extending longitudinally from a proximal end to a distal, the proximal end of the needle mounted within the proximal channel so that the needle passes through the lumen of the sheath.
- the device may further comprise an auxiliary tool sized and shaped to be inserted through the introducer port, the auxiliary tool directed through the lumen of the sheath when inserted through the introducer port.
- the distal portion may include a longitudinal slot extending longitudinally from the proximal end thereof, the longitudinal slot sized and shaped to slidably receive the introducer port of the central portion therein.
- the introducer port may include a slot sized and shaped to wedge a portion of the auxiliary tool therein to lock the auxiliary tool relative thereto.
- the present disclosure is also directed to a method for tissue sampling, comprising connecting an endoscope to a distal end of a distal portion of a handle member via a connector at the distal end of the distal portion, the handle member including the distal portion, a central portion and a proximal portion slidable with respect to one another, a distal end of the central portion connected to a sheath, which passes through the endoscope, and the proximal portion connected to a needle so that the needle passes through a lumen of the sheath, adjusting the distal portion, the central portion and proximal portion relative to one another so that the endoscope, sheath and needle are in a desired insertion configuration relative to one another, inserting the endoscope to a target area within a living body, advancing the sheath distally out of the endoscope such that a distal end thereof is proximate a target tissue to be sampled, inserting an auxiliary tool into the introducer port and through the sheath,
- the auxiliary tool may be an ultrasound probe providing visualization of the target tissue to be sampled.
- the method may further comprise connecting an aspirating source to a proximal end of the proximal portion to provide aspiration to the needle.
- the method may further comprise locking the auxiliary tool relative to the sheath by wedging the auxiliary tool within a slot along the introducer port.
- the method may further comprise adjusting a needle stop mounted over the proximal portion of the handle member to limit a maximum advancement of the needle relative to the sheath
- FIG. 1 shows a perspective view of a device according to an exemplary embodiment of the present invention
- FIG. 2 shows a longitudinal cross-sectional view of the device of FIG. 1 ;
- FIG. 3 shows a lateral cross-sectional view of an introducer port and auxiliary tool of the device of FIG. 1 , in a first configuration
- FIG. 4 shows a lateral cross-sectional view of the introducer port and auxiliary tool of the device of FIG. 1 , in a second configuration.
- the present invention relates to a handle for an apparatus for obtaining a tissue sample and, in particular, relates to FNA devices.
- Exemplary embodiments of the handle permit relative movement between a needle and an endoscope through which it is inserted, while also permitting insertion of an auxiliary tool such as, for example, an ultrasound probe.
- an auxiliary tool such as, for example, an ultrasound probe.
- the exemplary embodiments specifically describe use of the device during a bronchoscopic procedure, the device of the present invention may be used for any of a variety of endoscopic procedures.
- distal and proximal are intended to refer to a direction away from (distal) and toward (proximal) a user of the device.
- a handle device 100 comprises a distal portion 102 , a central portion 104 and a proximal portion 106 slidably coupled to one another in a telescoping fashion so that a sheath 108 and a needle 110 coupled thereto may be moved relative to one another and relative to an endoscope (not shown) to which the handle is coupled via movement of the distal portion 102 , central portion 104 and proximal portion 106 relative to one another.
- the central portion 104 additionally includes an introducer port 112 extending laterally therefrom, through which an auxiliary tool such as, for example, a narrow radial ultrasound probe 114 may be inserted through the sheath 108 alongside the needle 110 to visualize sampling of target tissue via the needle 110 .
- an auxiliary tool such as, for example, a narrow radial ultrasound probe 114 may be inserted through the sheath 108 alongside the needle 110 to visualize sampling of target tissue via the needle 110 .
- the endoscope is inserted through a trachea of the patient to a target area within the lungs.
- target tissue to be sampled may be located within secondary or tertiary bronchial passageways, through which the endoscope cannot be inserted.
- the sheath 108 and the needle 110 may be moved distally out of the distal end of the endoscope to enter the secondary and/or tertiary passageways. In such situations, it may not be possible to visualize the actual sampling of the target tissue via the endoscope vision system. As the introducer port 112 permits insertion of the ultrasound probe 114 , which is sized to be inserted through even narrow passageways of the body, through the sheath 108 alongside the needle 110 , the ultrasound probe 114 may be used to visualize the sampling. This helps ensure that a proper sample of tissue has been obtained by the needle 110 from the target tissue mass.
- the distal portion 102 extends longitudinally from a proximal end 116 to a distal end 118 and includes a distal channel 120 extending therethrough.
- the distal portion 102 also includes a longitudinal slot 122 extending from the proximal end 116 along a portion of a length thereof.
- the distal portion 102 may be configured as a C-shaped tube.
- the distal end 118 includes a connector 124 configured to be connected to an endoscope.
- the connector 124 may be rotatably mounted over the distal end 118 and include an internal threading 126 therein so that the connector 124 may receive a proximal end of the endoscope therein and be rotated relative thereto to threadedly engage the endoscope.
- the connector 124 may be non-movably mounted to the distal portion 102 so that the entire distal portion 102 must be rotated relative to the endoscope to threadedly engage the endoscope thereto.
- Other engagement mechanisms between the endoscope and the connector 124 are also possible.
- the connector 124 may be configured to permit a luer lock connection with the endoscope.
- the central portion 104 extends longitudinally from a proximal end 128 to a distal end 130 and includes a central channel 132 extending therethrough.
- the central channel 132 is tapered at a distal end 134 to fix a proximal end 136 of the sheath 108 within the distal end 134 so that the sheath 108 extends along, for example, a central axis of the central portion 104 .
- the central portion 104 is positioned within the distal portion 102 so that the introducer port 112 is longitudinally slidable within the longitudinal slot 122 and the proximal end 128 of the central portion 104 extends proximally of the proximal end 116 of the distal portion 102 .
- the introducer port 112 may include a locking feature 148 for locking the ultrasound probe 114 relative thereto.
- the opening 138 of the introducer port 112 may be sized and shaped to include the locking feature 148 , which may be configured as a slot 150 sized to engage the ultrasound probe 114 therein via a friction fit.
- the ultrasound probe 114 may be wedged into the slot 150 , as shown in FIG. 4 , to lock the ultrasound probe 114 relative thereto.
- the locking feature 148 may include any of a variety of locking mechanisms.
- the locking feature 148 may be configured as a clamp clampable over the ultrasound probe 114 .
- the central portion 104 may be locked relative to the distal portion 102 via a locking element 140 .
- the locking element 140 may be configured as, for example, a thumb screw threadedly engaging a hole 142 extending laterally through the distal portion 102 .
- the locking element is movable between a locking configuration, in which an end 144 thereof extends into the distal channel 120 to engage an exterior surface 146 of the central portion 104 to lock the central portion 104 relative to the distal portion, and an unlocked configuration, in which the end 144 does not extend into the distal channel 120 so that the central portion 104 is movable relative thereto.
- the locking element 144 may be rotated within the hole 142 to move the locking element 144 between the locked and unlocked configurations.
- the proximal portion 106 extends longitudinally from a proximal end 152 to a distal end 154 and includes a proximal channel 156 extending therethrough. A proximal end 158 of the needle 110 is fixed within the proximal channel 156 .
- the proximal portion 106 is slidably connected to the proximal end 128 of the central portion 104 and may, for example, be received within the central channel 132 so that the needle 110 extends distally from the proximal portion 106 into the sheath 108 and the proximal end 152 of the proximal portion 106 extends proximally of the proximal end 128 of the central portion 104 .
- proximal portion 106 longitudinal movement of the proximal portion 106 relative to the central portion 104 moves the needle 110 proximally and distally with respect to the sheath 108 .
- a length of the proximal portion 106 may be selected so that, even in a distal-most position relative to the central portion 104 , the proximal portion 106 does not interfere with the insertion of auxiliary tools through the insertion port 112 .
- the proximal portion 106 may be rotatable relative to the central portion 104 , and thereby the distal portion 102 , so that the needle 110 may be rotated relative to the sheath 108 and endoscope 102 through which the needle 110 is inserted, without rotating the entire device 100 .
- the proximal portion 106 may include an elongated slot extending laterally through a distal portion thereof so that, in a distal-most position relative to the central portion 104 , the elongated slot is aligned with the introducer port 112 so that the proximal portion 106 does not interfere with the use thereof.
- the proximal end 152 of the proximal portion 106 is configured so that, where desired, a stylet may be inserted through the proximal end 152 into the proximal channel 156 so that the stylet may be passed through the needle 110 .
- the proximal end 152 may also include a connection 180 such as, for example, a luer fitting, configured to couple a syringe or other aspirating source to the needle 110 .
- This desired position determines a maximum depth of insertion of the needle 110 relative to the sheath 108 .
- the collar 162 abuts the proximal end 128 of the central portion 104 , the proximal portion 106 is prevented from moving any farther distally relative thereto.
- the sheath 108 and the needle 110 may be passed through an endoscope coupled to the distal portion 102 via the connector 124 .
- Each of the proximal, central and distal portions 106 , 104 , 102 may be moved longitudinally relative to one another to move the needle 110 , sheath 108 relative to one another and to the endoscope.
- the sheath 108 extends longitudinally from the proximal end 136 fixed within the distal end 134 of the central channel 132 to a distal end 170 .
- the sheath 108 includes a lumen 172 extending therethrough, the lumen 172 sized and shaped to slidably accommodate both the needle 110 and an auxiliary tool such as the ultrasound probe 114 .
- the sheath 108 may be a double lumen sheath, a first lumen configured to receive the needle 110 and a second lumen configured to receive the auxiliary tool.
- a length of the sheath 108 may be selected so that, when the central portion 104 is moved distally relative to the distal portion 102 , the distal end 170 of the sheath 108 extends distally past a distal end of the endoscope.
- the needle 110 may be a standard FNA needle extending from the proximal end 158 to a distal end 174 and including a lumen (not shown) extending therethrough.
- a length of the needle 110 may be selected so that, when the proximal portion 106 is moved distally with respect to the central portion 104 , the distal end 174 of the needle 110 extends distally past the distal end 170 of the sheath 108 to be inserted into the target tissue to be sampled.
- a length of the ultrasound probe 114 may be selected so that, when inserted through the insertion port 112 and into the sheath 108 alongside the needle 110 , a distal end 176 of the ultrasound probe 114 is positioned proximate the distal end 174 of the needle 110 to visualize the sampling of the target tissue.
- an endoscope may be coupled to the device 100 via the connector 124 at the distal end 118 of the distal portion 102 .
- the distal portion 102 , central portion 104 and proximal portion 106 may be moved relative to one another to achieve a desired position and/or orientation of the endoscope, sheath 108 and the needle 110 relative to one another.
- the sheath 108 and needle 110 may be positioned so that the distal ends 170 , 174 , respectively, do not extend distally past the distal end of the endoscope. More particularly, the distal end 174 of the needle 110 also does not extend distally past the distal end 170 of the sheath 108 .
- the endoscope, sheath 108 and needle 110 have been positioned relative to one another, as desired, the endoscope, with the sheath 108 and the needle 110 received therein is passed through a body passage until a distal end of the endoscope is proximate a target area within a living body.
- the endoscope may be inserted through, for example, a bronchial passageway, but may be prevented from passing further into secondary and/or tertiary bronchial passageways.
- the sheath 108 , with the needle 110 extending therein is extended distally from the endoscope into the secondary and/or tertiary passageways by moving the central portion 104 distally relative to the distal portion 102 .
- an auxiliary tool such as the ultrasound probe 114 may be inserted into the introducer port 112 and through the lumen 172 of the sheath 108 so that the distal end 176 extends distally past the distal end 170 of the sheath 108 to provide visualization of the tissue to be sampled.
- the ultrasound probe 114 may be fixed in the desired position via the locking feature 148 . In one embodiment, the ultrasound probe 114 may be wedged into the slot 150 .
- the needle 110 may then be moved distally relative to the sheath 108 by moving the proximal portion 106 distally relative to the central portion 104 so that the distal end 174 of the needle 110 extends distally past the distal end 170 of the sheath 108 .
- the visualization provided by the ultrasound probe 114 ensures that the target tissue is being correctly sampled via the needle 110 .
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Abstract
Description
- This application claims priority to U.S. Provisional Patent Application Ser. No. 62/212,866 filed Sep. 1, 2015; the disclosure of which is incorporated herewith by reference.
- Biopsies may be performed with Endoscopic Ultrasound Fine Needle Aspiration (“EUS-FNA”) devices to obtain cells or small samples of tissue from, for example, the breast, liver or lung for cytology studies, endoscopy, oncology or bronchology. As understood by those skilled in the art, biopsy needles enable the capture of samples to facilitate diagnosis and treatment. These biopsy needles are generally connected at their proximal ends to handles to facilitate their insertion into target tissue. Currently available handles are typically formed as two or more overlapping substantially cylindrical elements with a first element attached to an endoscope and a second larger diameter element overlapping a proximal portion of the first element being used to advance the needle into a target site in a living body.
- The present disclosure is directed to a handle for a medical device, comprising a distal portion, a central portion and a proximal portion. The distal portion extending longitudinally from a proximal end to a distal end and including a distal channel extending therethrough, the distal end of the distal portion including a connector configured to connect to a proximal end of an endoscope. The central portion is sized and shaped to be slidably connected to the proximal end of the distal portion, the central portion extending longitudinally from a proximal end to a distal end and including a central channel (i.e., a channel located in the central portion) extending therethrough, the distal end of the central portion being configured to be connected to a sheath, the central portion including an introducer port extending laterally therefrom so that an auxiliary tool inserted through the introducer port is directed through a lumen of the sheath. The proximal portion sized and shaped to be slidably connected to the proximal end of the central portion, the proximal portion extending longitudinally from a proximal end to a distal end and including a proximal channel extending therethrough, the distal end of the proximal portion being configured to be connected to a needle so that the needle is passed through the lumen of the sheath, the distal, central and proximal portions are longitudinally movable relative to one another to adjust a relative positioning between the endoscope, sheath and needle.
- In an exemplary embodiment, the distal portion may include a longitudinal slot extending longitudinally from the proximal end thereof, the longitudinal slot sized and shaped to slidably receive the introducer port of the central portion therein.
- In an exemplary embodiment, the distal portion may be a C-shaped tube.
- In an exemplary embodiment, the proximal end of the proximal portion may include a connection mechanism configured to connect the needle to an aspirating source.
- In an exemplary embodiment, the introducer port may include a locking feature for locking the auxiliary tool relative thereto.
- In an exemplary embodiment, the locking feature may include one of a slot sized and shaped to wedge a portion of the auxiliary tool therein and a clamp configured to clamp the auxiliary tool to the introducer port.
- In an exemplary embodiment, the handle may further comprise a locking element for locking the distal and central portions relative to one another.
- In an exemplary embodiment, the locking element may include a thumb screw threadedly engaging a hole extending laterally through the distal portion so that, when in a locked configuration, an end of the thumb screw engages an exterior surface of the central portion.
- In an exemplary embodiment, the handle may further comprise an adjustable needle stop configured to limit advancement of the needle relative to the sheath.
- In an exemplary embodiment, the adjustable needle stop may include a collar slidably mounted over the proximal portion and a thumb screw threadedly engaging a hole extending laterally through the collar so that, when the thumb screw is tightened within the hole, the adjustable needle stop is fixed in a desired position along the proximal portion, a cross-sectional area of the collar being larger than a cross-sectional area of the central portion.
- The present disclosure is also directed to a tissue sampling device, comprising a handle member including a distal portion extending longitudinally from a proximal end to a distal end and including a distal channel extending therethrough, a central portion sized and shaped to be slidably connected to the proximal end of the distal portion, the central portion extending longitudinally from a proximal end to a distal end and including a central channel (i.e., a channel located in the central portion) extending therethrough along with an introducer port extending laterally therefrom, and a proximal portion sized and shaped to be slidably connected to the proximal end of the central portion, the proximal portion extending longitudinally from a proximal end to a distal end and including a proximal channel extending therethrough. The device also comprises an endoscope connected to the distal portion via a connector at the distal end thereof, a sheath extending longitudinally from a proximal end to a distal end and including a lumen extending therethrough, the proximal end of the sheath connected to a distal end of the central portion, and a needle extending longitudinally from a proximal end to a distal, the proximal end of the needle mounted within the proximal channel so that the needle passes through the lumen of the sheath.
- In an exemplary embodiment, the device may further comprise an auxiliary tool sized and shaped to be inserted through the introducer port, the auxiliary tool directed through the lumen of the sheath when inserted through the introducer port.
- In an exemplary embodiment, the auxiliary tool may be an ultrasound probe.
- In an exemplary embodiment, the distal portion may include a longitudinal slot extending longitudinally from the proximal end thereof, the longitudinal slot sized and shaped to slidably receive the introducer port of the central portion therein.
- In an exemplary embodiment, the introducer port may include a slot sized and shaped to wedge a portion of the auxiliary tool therein to lock the auxiliary tool relative thereto.
- The present disclosure is also directed to a method for tissue sampling, comprising connecting an endoscope to a distal end of a distal portion of a handle member via a connector at the distal end of the distal portion, the handle member including the distal portion, a central portion and a proximal portion slidable with respect to one another, a distal end of the central portion connected to a sheath, which passes through the endoscope, and the proximal portion connected to a needle so that the needle passes through a lumen of the sheath, adjusting the distal portion, the central portion and proximal portion relative to one another so that the endoscope, sheath and needle are in a desired insertion configuration relative to one another, inserting the endoscope to a target area within a living body, advancing the sheath distally out of the endoscope such that a distal end thereof is proximate a target tissue to be sampled, inserting an auxiliary tool into the introducer port and through the sheath, and advancing the needle distally out of the sheath so that a distal end of the needle is inserted into the target tissue to be sampled.
- In an embodiment, the auxiliary tool may be an ultrasound probe providing visualization of the target tissue to be sampled.
- In an embodiment, the method may further comprise connecting an aspirating source to a proximal end of the proximal portion to provide aspiration to the needle.
- In an embodiment, the method may further comprise locking the auxiliary tool relative to the sheath by wedging the auxiliary tool within a slot along the introducer port.
- In an embodiment, the method may further comprise adjusting a needle stop mounted over the proximal portion of the handle member to limit a maximum advancement of the needle relative to the sheath
-
FIG. 1 shows a perspective view of a device according to an exemplary embodiment of the present invention; -
FIG. 2 shows a longitudinal cross-sectional view of the device ofFIG. 1 ; -
FIG. 3 shows a lateral cross-sectional view of an introducer port and auxiliary tool of the device ofFIG. 1 , in a first configuration; and -
FIG. 4 shows a lateral cross-sectional view of the introducer port and auxiliary tool of the device ofFIG. 1 , in a second configuration. - The present invention may be further understood with reference to the following description and the appended drawings, wherein like elements are referred to with the same reference numerals. The present invention relates to a handle for an apparatus for obtaining a tissue sample and, in particular, relates to FNA devices. Exemplary embodiments of the handle permit relative movement between a needle and an endoscope through which it is inserted, while also permitting insertion of an auxiliary tool such as, for example, an ultrasound probe. Although the exemplary embodiments specifically describe use of the device during a bronchoscopic procedure, the device of the present invention may be used for any of a variety of endoscopic procedures. It should be noted that the terms “distal” and “proximal,” as used herein, are intended to refer to a direction away from (distal) and toward (proximal) a user of the device.
- As shown in
FIGS. 1-4 , ahandle device 100 according to an exemplary embodiment of the present invention comprises adistal portion 102, acentral portion 104 and aproximal portion 106 slidably coupled to one another in a telescoping fashion so that asheath 108 and aneedle 110 coupled thereto may be moved relative to one another and relative to an endoscope (not shown) to which the handle is coupled via movement of thedistal portion 102,central portion 104 andproximal portion 106 relative to one another. Thecentral portion 104 additionally includes anintroducer port 112 extending laterally therefrom, through which an auxiliary tool such as, for example, a narrowradial ultrasound probe 114 may be inserted through thesheath 108 alongside theneedle 110 to visualize sampling of target tissue via theneedle 110. For example, during a bronchoscopic biopsy, the endoscope is inserted through a trachea of the patient to a target area within the lungs. In some cases, however, target tissue to be sampled may be located within secondary or tertiary bronchial passageways, through which the endoscope cannot be inserted. In these cases, thesheath 108 and theneedle 110 may be moved distally out of the distal end of the endoscope to enter the secondary and/or tertiary passageways. In such situations, it may not be possible to visualize the actual sampling of the target tissue via the endoscope vision system. As theintroducer port 112 permits insertion of theultrasound probe 114, which is sized to be inserted through even narrow passageways of the body, through thesheath 108 alongside theneedle 110, theultrasound probe 114 may be used to visualize the sampling. This helps ensure that a proper sample of tissue has been obtained by theneedle 110 from the target tissue mass. - In particular, the
distal portion 102 extends longitudinally from aproximal end 116 to adistal end 118 and includes adistal channel 120 extending therethrough. Thedistal portion 102 also includes alongitudinal slot 122 extending from theproximal end 116 along a portion of a length thereof. In one embodiment, thedistal portion 102 may be configured as a C-shaped tube. Thedistal end 118 includes aconnector 124 configured to be connected to an endoscope. In one embodiment, theconnector 124 may be rotatably mounted over thedistal end 118 and include aninternal threading 126 therein so that theconnector 124 may receive a proximal end of the endoscope therein and be rotated relative thereto to threadedly engage the endoscope. In another embodiment, theconnector 124 may be non-movably mounted to thedistal portion 102 so that the entiredistal portion 102 must be rotated relative to the endoscope to threadedly engage the endoscope thereto. Other engagement mechanisms between the endoscope and theconnector 124 are also possible. For example, in another embodiment, theconnector 124 may be configured to permit a luer lock connection with the endoscope. - The
central portion 104 extends longitudinally from aproximal end 128 to adistal end 130 and includes acentral channel 132 extending therethrough. Thecentral channel 132 is tapered at adistal end 134 to fix aproximal end 136 of thesheath 108 within thedistal end 134 so that thesheath 108 extends along, for example, a central axis of thecentral portion 104. Thecentral portion 104 may be slidably received through theproximal end 116 of thedistal portion 102 within thedistal channel 120 so that thecentral portion 104 and thedistal portion 102 may be moved longitudinally relative to one another to move thesheath 108 proximally and distally relative to an endoscope to which thedistal portion 102 has been coupled. - Proximally of the
proximal end 136 of thesheath 108, thecentral portion 104 includes theintroducer port 112 extending laterally therefrom, in communication with thecentral channel 132. Anopening 138 of theintroducer port 112 extends toward theproximal end 128 of thecentral portion 104 so that an auxiliary tool such as theultrasound probe 114 may be inserted through theopening 138 of theintroducer port 112 into thecentral channel 132 permitting theultrasound probe 114 to be inserted through thesheath 108. The tapering of thedistal end 134 of thecentral channel 132 directs theultrasound probe 114 into thesheath 108 as theultrasound probe 114 is moved distally relative thereto. Thecentral portion 104 is positioned within thedistal portion 102 so that theintroducer port 112 is longitudinally slidable within thelongitudinal slot 122 and theproximal end 128 of thecentral portion 104 extends proximally of theproximal end 116 of thedistal portion 102. - The
introducer port 112 may include alocking feature 148 for locking theultrasound probe 114 relative thereto. In one exemplary embodiment, as shown inFIGS. 3 and 4 , theopening 138 of theintroducer port 112 may be sized and shaped to include thelocking feature 148, which may be configured as aslot 150 sized to engage theultrasound probe 114 therein via a friction fit. In particular, once theultrasound probe 114 has been inserted through thesheath 108 as desired, theultrasound probe 114 may be wedged into theslot 150, as shown inFIG. 4 , to lock theultrasound probe 114 relative thereto. Although the exemplary embodiments show and describe thelocking feature 148 as a slotted wedge, other wedge configurations may also be possible. Thelocking feature 148 may include any of a variety of locking mechanisms. For example, in another embodiment, thelocking feature 148 may be configured as a clamp clampable over theultrasound probe 114. - The
central portion 104 may be locked relative to thedistal portion 102 via alocking element 140. The lockingelement 140 may be configured as, for example, a thumb screw threadedly engaging ahole 142 extending laterally through thedistal portion 102. The locking element is movable between a locking configuration, in which anend 144 thereof extends into thedistal channel 120 to engage anexterior surface 146 of thecentral portion 104 to lock thecentral portion 104 relative to the distal portion, and an unlocked configuration, in which theend 144 does not extend into thedistal channel 120 so that thecentral portion 104 is movable relative thereto. The lockingelement 144 may be rotated within thehole 142 to move thelocking element 144 between the locked and unlocked configurations. - The
proximal portion 106 extends longitudinally from aproximal end 152 to adistal end 154 and includes aproximal channel 156 extending therethrough. Aproximal end 158 of theneedle 110 is fixed within theproximal channel 156. Theproximal portion 106 is slidably connected to theproximal end 128 of thecentral portion 104 and may, for example, be received within thecentral channel 132 so that theneedle 110 extends distally from theproximal portion 106 into thesheath 108 and theproximal end 152 of theproximal portion 106 extends proximally of theproximal end 128 of thecentral portion 104. Thus, longitudinal movement of theproximal portion 106 relative to thecentral portion 104 moves theneedle 110 proximally and distally with respect to thesheath 108. In one embodiment, a length of theproximal portion 106 may be selected so that, even in a distal-most position relative to thecentral portion 104, theproximal portion 106 does not interfere with the insertion of auxiliary tools through theinsertion port 112. In this embodiment, theproximal portion 106 may be rotatable relative to thecentral portion 104, and thereby thedistal portion 102, so that theneedle 110 may be rotated relative to thesheath 108 andendoscope 102 through which theneedle 110 is inserted, without rotating theentire device 100. In another embodiment, however, theproximal portion 106 may include an elongated slot extending laterally through a distal portion thereof so that, in a distal-most position relative to thecentral portion 104, the elongated slot is aligned with theintroducer port 112 so that theproximal portion 106 does not interfere with the use thereof. - The
proximal end 152 of theproximal portion 106 is configured so that, where desired, a stylet may be inserted through theproximal end 152 into theproximal channel 156 so that the stylet may be passed through theneedle 110. Theproximal end 152 may also include aconnection 180 such as, for example, a luer fitting, configured to couple a syringe or other aspirating source to theneedle 110. - The
proximal portion 106 may also include anadjustable needle stop 160. In one embodiment, theneedle stop 160 may include acollar 162 and athumb screw 164. Thecollar 162 is slidably mounted over a portion of theproximal portion 106, proximally of theproximal end 128 of thecentral portion 104. Thecollar 162 may be moved to a desired position along theproximal portion 106 and fixed in the desired position via thethumb screw 164. In particular, thethumb screw 164 extends through a correspondingly threadedhole 166 extending laterally through thecollar 162 to engage anexterior surface 168 of theproximal portion 106, when thecollar 162 is in the desired position. This desired position determines a maximum depth of insertion of theneedle 110 relative to thesheath 108. For example, when thecollar 162 abuts theproximal end 128 of thecentral portion 104, theproximal portion 106 is prevented from moving any farther distally relative thereto. - As described above, the
sheath 108 and theneedle 110 may be passed through an endoscope coupled to thedistal portion 102 via theconnector 124. Each of the proximal, central anddistal portions needle 110,sheath 108 relative to one another and to the endoscope. Thesheath 108 extends longitudinally from theproximal end 136 fixed within thedistal end 134 of thecentral channel 132 to adistal end 170. Thesheath 108 includes alumen 172 extending therethrough, thelumen 172 sized and shaped to slidably accommodate both theneedle 110 and an auxiliary tool such as theultrasound probe 114. In another embodiment, thesheath 108 may be a double lumen sheath, a first lumen configured to receive theneedle 110 and a second lumen configured to receive the auxiliary tool. A length of thesheath 108 may be selected so that, when thecentral portion 104 is moved distally relative to thedistal portion 102, thedistal end 170 of thesheath 108 extends distally past a distal end of the endoscope. - The
needle 110 may be a standard FNA needle extending from theproximal end 158 to adistal end 174 and including a lumen (not shown) extending therethrough. A length of theneedle 110 may be selected so that, when theproximal portion 106 is moved distally with respect to thecentral portion 104, thedistal end 174 of theneedle 110 extends distally past thedistal end 170 of thesheath 108 to be inserted into the target tissue to be sampled. Similarly, a length of theultrasound probe 114 may be selected so that, when inserted through theinsertion port 112 and into thesheath 108 alongside theneedle 110, adistal end 176 of theultrasound probe 114 is positioned proximate thedistal end 174 of theneedle 110 to visualize the sampling of the target tissue. - According to an exemplary method using the
device 100, an endoscope may be coupled to thedevice 100 via theconnector 124 at thedistal end 118 of thedistal portion 102. Thedistal portion 102,central portion 104 andproximal portion 106 may be moved relative to one another to achieve a desired position and/or orientation of the endoscope,sheath 108 and theneedle 110 relative to one another. For example, during insertion, thesheath 108 andneedle 110 may be positioned so that the distal ends 170, 174, respectively, do not extend distally past the distal end of the endoscope. More particularly, thedistal end 174 of theneedle 110 also does not extend distally past thedistal end 170 of thesheath 108. Once the endoscope,sheath 108 andneedle 110 have been positioned relative to one another, as desired, the endoscope, with thesheath 108 and theneedle 110 received therein is passed through a body passage until a distal end of the endoscope is proximate a target area within a living body. The endoscope may be inserted through, for example, a bronchial passageway, but may be prevented from passing further into secondary and/or tertiary bronchial passageways. In this case, thesheath 108, with theneedle 110 extending therein, is extended distally from the endoscope into the secondary and/or tertiary passageways by moving thecentral portion 104 distally relative to thedistal portion 102. - Once the
distal end 170 of thesheath 108 is proximate the target tissue to be sampled, an auxiliary tool such as theultrasound probe 114 may be inserted into theintroducer port 112 and through thelumen 172 of thesheath 108 so that thedistal end 176 extends distally past thedistal end 170 of thesheath 108 to provide visualization of the tissue to be sampled. Upon positioning theultrasound probe 114 in a desired position relative to thesheath 108, theultrasound probe 114 may be fixed in the desired position via thelocking feature 148. In one embodiment, theultrasound probe 114 may be wedged into theslot 150. Theneedle 110 may then be moved distally relative to thesheath 108 by moving theproximal portion 106 distally relative to thecentral portion 104 so that thedistal end 174 of theneedle 110 extends distally past thedistal end 170 of thesheath 108. The visualization provided by theultrasound probe 114 ensures that the target tissue is being correctly sampled via theneedle 110. - While embodiments have been described above, a number of modifications and changes may be made without departing from the scope of the disclosure. Thus, it is intended that the present disclosure cover modifications and variations provided that they come within the scope of the appended claims and their equivalents.
Claims (21)
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US20210106317A1 (en) * | 2019-10-09 | 2021-04-15 | Praxis Holding Llc | Telescoping needle assembly with rotating needle |
CN113710305A (en) * | 2019-05-24 | 2021-11-26 | 贝克顿·迪金森公司 | Needle track assist device including components and method thereof |
AU2020278580B2 (en) * | 2019-05-17 | 2023-03-09 | Boston Scientific Scimed, Inc. | Devices to access peripheral regions of the lung for direct visualization with tool attachment |
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DE102019003965A1 (en) * | 2019-06-05 | 2020-12-10 | Joimax Gmbh | Surgical needle set and method for determining the position of a surgical instrument |
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Also Published As
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JP2018529403A (en) | 2018-10-11 |
JP2020096858A (en) | 2020-06-25 |
CN107920811A (en) | 2018-04-17 |
JP6906073B2 (en) | 2021-07-21 |
US20210000457A1 (en) | 2021-01-07 |
WO2017040414A1 (en) | 2017-03-09 |
EP3344154B1 (en) | 2021-01-13 |
EP3909517A1 (en) | 2021-11-17 |
CN116942216A (en) | 2023-10-27 |
EP3344154A1 (en) | 2018-07-11 |
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