WO2024156839A1

WO2024156839A1 - Medical device for securing a catheter and a method of using a medical device to secure a catheter

Info

Publication number: WO2024156839A1
Application number: PCT/EP2024/051846
Authority: WO
Inventors: Alexander VAN DAMME; Simon CALLAERTS
Original assignee: Bedal International Nv
Priority date: 2023-01-27
Filing date: 2024-01-26
Publication date: 2024-08-02

Abstract

A medical device (10) for securing a catheter, comprising: - a body member (12) having a first side (18); a second side (20) opposite the first side, the second side provided with at least one pair of posts (22); a channel (24) defined in between the at least one pair of posts (22) and being configured to receive the catheter (60); - a retaining strap (14) having an opening (38) adapted to enclose and engage the at least one pair of posts (22) to clamp the catheter in an engaged position of the retaining strap (14), - a partially engaged position fixing mechanism configured to fix the retaining strap (14) in a partially engaged position wherein only one post of one pair of posts is engaged by the retaining strap.

Description

Medical device for securing a catheter and a method of using a medical device to secure a catheter

Field of the invention

The present invention relates to a medical device for fixating different types of catheters, which are used in healthcare and in particular to a medical device for fixating such catheters to a living creature.

Background

In healthcare, a catheter is used to provide an access to the human body for drainage of a bodily fluid or for delivery of medicinal drugs, parenteral nutrition, blood or blood components or other liquids. A catheter is typically used for patients that are ill or during the performance of surgical procedures. Depending on the goal which is desired to be achieved and sometimes also depending on the patient or his/her medical condition, different catheters and different application methods can be selected.

KR20180052327 discloses a medical tube securing clip for securing a drain tube inserted from a drain tube of a medical low-pressure continuous aspirator and inserted into a lesion portion.

Another specific type of catheter is the epidural catheter, which is mainly used for drug administration such as epidural anesthesia or contrast agents. Epidural anesthesia can be injected into the epidural space around the spinal cord. These epidural catheters are than placed into the epidural space, and sometimes have to stay in place for several days. Both a correct introduction of the catheter and a correct fixation of the catheter are matters of utmost importance.

A second type of catheter is the peripheral nerve block catheter, which is a catheter which closely resembles the epidural catheter and being mainly used for local anesthesia.

Another type of catheter is the peripherally inserted central venous catheter for premature babies and neonates being mainly suitable for the delivery of medication and/or parenteral nutrition.

These types of catheters generally have a French size (Fr) or gauge value with a maximum residing around 5 Fr and 16 (G) respectively, which corresponds to an external diameter of about 1.67 millimeters. A disadvantage of the securement of catheters to a patient is that it often is a burden for patients in terms of wearing comfort. For example, excessive movement whilst a catheter or part thereof is applied to the human body may be difficult to nearly impossible as the position of the catheter within the body should under all circumstances remain fixed. Accidental catheter removal, upon the exertion of a pulling force should be avoided. Also, a change in position of the catheter (e.g. catheter dislocation or migration) may prevent proper operation and in some circumstances could even lead to dangerous or life- threatening situations. Therefore, a proper fixation of the catheter is of crucial importance to prevent critical situations and to allow patients to move more freely.

Adequate fixation of these catheters can be achieved using catheter fixation devices. These stabilization devices positively influence the lifetime of the catheter, decrease the number of catheter fixation procedures and the number of complications (e.g. phlebitis, extravasion or infections), all of which have been demonstrated in the scientific literature.

The fixation of epidural catheters is crucial, since only the slightest inward or outward migration of these catheters may have serious consequences on for example the efficacy of epidural analgesia. Known medical devices for securing these types of catheters are commercially available. However, these fixation means are often unwieldy and bulky. A number of known catheter fixation devices fail to adequately prevent small longitudinal movements of the catheter, also known as micro -pistoning, leading to increased risk of infections.

WO 2021/105415 Al discloses a catheter retaining device. The device disclosed in that document is however not entirely satisfactory. One potential problem is that when the retaining strap is in the engaged position, a piece of clothing may be caught in between the opening and one post. This for example is caused by when the opening is made to enclose the pair of posts, the opening not only enclosed the pair of posts but also inadvertently trapped a piece of clothing between the opening and the post. This increases the risk that the retaining strap is moved accidentally from the engaged position to the disengaged position when the patient moves his clothes. The catheter can subsequently be detached from the catheter retaining device.

Another potential problem is that when the catheter retaining device comprises two pairs of posts arranged along the longitudinal direction of the catheter, in the engaged position of the retaining strap a health professional may only enclose one pair of posts but not both pairs of them. This means that instead of two pairs of posts which are arranged along the catheter clamping the latter, only one pair of posts actually clamps the catheter. This decreases the clamping force applied on the catheter. Summary

One of the objectives of the present disclosure is to provide a medical device which can be fixed to a catheter in a better way. Another objective of the present disclosure is to provide a medical device with a reduced risk of unexpected opening, for example due to a piece of clothing being caught between the retaining strap and the pair(s) of posts.

According to the first aspect of the present disclosure is a medical device for securing a catheter to a living creature, comprising: a body member having a first side adapted to be removably attached to the living creature; a second side opposite the first side, the second side provided with at least one pair of posts; a channel defined in between the at least one pair of posts and being configured to receive the catheter; a retaining strap having an opening adapted to enclose and engage said at least one pair of posts to clamp the catheter in an engaged position of said retaining strap.

The medical device further comprises a partially engaged position fixing mechanism configured to fix the retaining strap in a partially engaged position wherein only one post of one pair of posts is engaged by the retaining strap, the retaining strap being moveable between the partially engaged position and the engaged position for clamping said catheter.

Thanks to these features it is easier for a health professional to move the retaining strap from the partially engaged position to the engaged position, since at least one post of at least one of the pair(s) of posts already engages the retaining strap.

The medical device according to the first aspect can also have one or several following features, according to all the technically possible combinations:

In the partially engaged position the retaining strap is connected to the body member at a coupling location, wherein at least one post of at least one of the pair(s) of posts comprises an abutment for fixing the retaining strap in the engaged position, each pair of posts comprising a proximal post and a distal post farther to the coupling location compared to the proximal post, wherein in the partially engaged position, the abutment of at least one proximal post engages the retaining strap and none of the distal post(s) engages the retaining strap. Thanks to these features, in the partially engaged position the retaining strap is already fixed between the coupling location and at least one proximal post. When moving the retaining strap from the partially engaged position to the engaged position it is only necessary to move the part of the retaining strap which is between the proximal post and the distal post. In this way, moving the retaining strap to the engaged position is made easier.

The body member preferably comprises a plurality of pairs of posts, wherein in the partially engaged position the retaining strap only engages with one of the posts of the pairs of posts, more preferably only at least two proximal posts as mentioned above, most preferably all the proximal posts. With the retainer strap engages at least two proximal posts in the partially engaged position the retailer strap can be maintained in the partially engaged position more solidly.

The coupling location fixes a fixing length of the retaining strap to the body member, the fixing length being at least 30%, preferably at least 50% of the maximal width of the retaining strap measured in the longitudinal direction of the catheter.

With a substantial length of the retaining strap fixed to the body member the partial engaged position fixing mechanism can effectively keep the retaining strap in the partially engaged position, in particular keep the retaining strap engaged with the proximal post of at least two pairs of posts. Consequently when a health professional moves the retaining strap from the partially engaged position to the engaged position the retaining strap is more likely to enclose and engage at least two pairs of posts, in some cases to enclose and engage all the pairs of posts.

The partially engaged position fixing mechanism comprises an aperture on the retaining strap and a protrusion on the body member configured to be inserted into the aperture to fix the retaining strap in the partially engaged position.

According to the second aspect of the present disclosure the body member further comprises an engaged position fixing mechanism configured to fix the retaining strap in the engaged position.

With the engaged position fixing mechanism the risk that the retaining strap ceases to engage the at least one pair of posts is decreased. Indeed if the retaining strap were to move away from the engaged position it would need not only to overcome the fixing force between the retaining strap and the at least one pair of posts, but also to overcome the fixing force applied by the engaged position fixing mechanism. In this way the retaining strap will remain in its engaged position, and the catheter can be fixed in the channel in a more secure manner.

Although it is preferred to provide a medical device with both a partially engaged position fixing mechanism as described above and an engaged position fixing mechanism, thereby improving the reliability of the connection of the catheter to the patient, it also envisaged to provide a medical device without a partially engaged position fixing mechanism and only an engaged position fixing mechanism.

The medical device according to the second aspect can also have one or several following features, according to all the technically possible combinations:

In the partially engaged position the retaining strap is connected to the body member at a coupling location, wherein the engaged position fixing mechanism is located farther to the coupling location compared to the at least one pair of posts.

The engaged position fixing mechanism may therefore apply a greater fixing torque on the retaining strap than the fixing torque applied by the pair(s) of posts on the retaining strap. This acts as an additional and more effective fixing mechanism to keep the retaining strap in the engaged position.

The engaged position fixing mechanism comprises a distal loop on the body member, the retaining strap being configured to be inserted into the distal loop to fix the retaining strap in the engaged position.

Inserting the retaining strap into the distant loop is a simple yet effective way of fixing the retaining strap in the engaged position.

The engaged position fixing mechanism is configured to apply a fixing force on the retaining strap greater than the fixing force applied by the at least one pair of posts on the retaining strap.

This ensures a more secure fixation of the retaining strap by the engaged position fixing mechanism compared to the at least one pair of posts.

The body member comprises a gap arranged at the height of the transition between the pair(s) of posts and the second side of the body member for partially disconnecting the pair(s) of posts and the body member to enable the pair(s) of posts to be tilted towards each other in the engaged position independently from the body member.

This enables the tight securement of the catheter within the channel of the medical device even when the medical device is secured to a curved surface (e.g. arm of a patient).

The pair(s) of posts inhibits at least a longitudinal movement of the catheter along the channel in the engaged position.

Any feature of the first aspect may be combined with any feature of the second aspect.

The present disclosure also concerns the use of the medical device as described above for securing a catheter to a living creature.

The present disclosure also concerns a kit comprising the medical device as described above, a catheter and optionally an adhesive foil configured to fix the medical device to a living creature.

The present disclosure also concerns a method of using a medical device to secure a catheter to a living creature, the medical device comprising a body member and a retaining strap, the body member comprising at least one pair of posts, the catheter being located in a channel defined in between the at least one pair of posts while the retaining strap is in a partially engaged position wherein only one post of one pair of posts is engaged by the retaining strap, the method comprising the step of: moving the retaining strap to an engaged position where an opening of the retaining strap encloses and engages the at least one pair of posts to clamp the catheter.

The method can also have one or several following features, according to all the technically possible combinations:

Preferably, the method excludes a step of inserting the catheter into the living creature. The catheter is preferably already located in said channel.

The method further comprises, after moving the retaining strap to the engaged position, the step of fixing the retaining strap in the engaged position by an engaged position fixing mechanism, wherein preferably the engaged position fixing mechanism applies a fixing force on the retaining strap greater than the fixing force applied by the at least one pair of posts on the retaining strap. After moving the retaining strap to the engaged position and before fixing the retaining strap in the engaging position by the engaged position fixing mechanism, the method further comprises the step of attaching the body member to the living creature.

Brief description of the Figures

The accompanying drawings are used to illustrate presently preferred non-limiting exemplary embodiments of the medical device and the method of the present invention. The above and other advantages of the features and objects of the invention will become more apparent and the invention will be better understood from the following detailed description when read in conjunction with the accompanying drawings, in which:

Fig. 1 shows the perspective view of the first exemplary embodiment of the medical device according to the present disclosure, the retaining strap being in its disengaged position;

Figs. 2 and 3 show the side and top views of the medical device in Fig. 1;

Fig. 4 shows the perspective view of a second exemplary embodiment of the medical device according to the present disclosure, the retaining strap being in its disengaged position;

Figs. 5 and 6 show the side and top views of the medical device in Fig. 4;

Fig, 7 shows the perspective view of the medical device in Fig. 1, the retaining strap being in its partially engaged position;

Figs. 8 and 9 show the side and top views of the medical device in Fig. 7 with the retaining strap in its partially engaged position;

Fig. 10 shows the perspective view of the medical device in Fig. 1, the retaining strap being in its engaged position;

Figs. 11 and 12 show the side and top views of the medical device in Fig. 10 with the retaining strap in its engaged position;

Fig. 13 shows another embodiment of the present disclosure. Detailed description of the embodiments

A medical device 10 according to the first embodiment is shown in Figs. 1 - 3. The medical device 10 is configured for securing a catheter 60 to a living creature. The medical device 10 comprises a body member 12 and a retaining strap 14. The body member 12 comprises a first side 18 and a second side 20 opposite to the first side 18. The first aside 18 is adapted to be removably attached to the living creature, for example to the skin of a patient. The second side 20 is provided with at least one pair of posts 22. According to the embodiments in the Figures the second side 20 is provided with two pairs of posts 22 along the longitudinal direction of the catheter 60. Alternatively the second side 20 may be provided with only one pair of posts 22 such as shown in Fig. 13, or be provided with more than two pairs of posts 22.

The at least one pair of posts 22 defines a channel 24 in between them. The channel 24 is configured to receive the catheter 60. The channel 24 extends in the longitudinal direction of the catheter 60. The diameter of the catheters intended to be received by the channel 24 of the first embodiment is typically comprised between 11 Fr and 18 Fr. According to some embodiments such as those shown in Fig. 1 - 3 the channel 24 is U-shaped narrowing towards the second side 20.

Each pair of posts 22 comprises a proximal post 28 and a distal post 30, as will be described in more detail below.

Preferably, the connection between at least one of the posts of the pair of posts 22 and the body member 12 will be cut at the transition area between both parts, thereby for example resulting in an incision (hereinafter also referred to as ‘gap’).

According to some embodiments the body member 12 comprises a gap 32 arranged at the height of the transition between the pair(s) of posts 22 and the second side 20 of the body member 12. The gap 32 is configured for partially disconnecting the pair(s) of posts 22 and the body member 12 to enable the pair(s) of posts 22 to be tilted towards each other in an engaged position independently from the body member 12. The tilting motion of the pair of posts 22 happens independently from the body member 12 since said pair of posts 22 and the body member 12 are partially disconnected. This partially disconnecting is arranged by the gap 32. According to some embodiments the first side 18 of the body member 12 comprises two gaps 32, one besides each post of the pair of posts 22, which makes that the pair of posts 22 are only partially connected to the body member 12. The pair of posts 22, the gap 32, and the transition between the pair of posts 22 and the second side 20 of the body member 12 are described in more detail in the application WO 2021/105415 Al which is incorporated in this application in entirety.

The retaining strap 14 comprises a connecting segment 34. The retaining strap 14 also comprises an engaging segment 36. The engaging segment 36 comprises an opening 38. The retaining strap 14 also comprises a handling segment 40. The connecting segment 34 is located on one side of the engaging segment 36. The handling segment 40 is located on the other side of the engaging segment 36 opposite the connecting segment 34.

The opening 38 is adapted to enclose and engage the at least one pair of posts 22 to clamp the catheter 60 (not shown in the Figures) in an engaged position of the retaining strap 14. Figs. 9 - 12 show the retaining strap 14 in its engaged position. The pair(s) of posts 22 inhibits at least a longitudinal movement of the catheter 60 along the channel 24 in the engaged position.

When no force is applied to the retaining strap 14 the opening 38 for example has a width measured in a transverse direction (perpendicular to the longitudinal direction) lower than the width of the pair of posts 22 measured in the transverse direction. According to some embodiments the retaining strap 14 comprises an opening 38 for each pair of posts 22. Alternatively the retaining strap 14 comprises one single opening 38 for at least two pairs of posts 22, for example for all the pairs of posts 22. This alternative simplifies moving the retaining strap 14 from its partially engaged position to the engaged position, as it is not necessary to insert each pair of posts 22 into its respective opening 38.

Preferably at least one post of at least one of the pair(s) of posts 22, for example the distal post 30, comprises an abutment 42 for fixing the retaining strap 14 in the engaged position. In an embodiment, the abutment 42 lies at the outer side of the at least one post, the outer side being opposite to the channel side. In preferred embodiments, the abutments 42 are made of the same material as the pair of posts 22, so that each abutment 42 is integrally formed with the corresponding post. The abutments 42 are generally present in order to immobilize the retaining strap 14. More specifically, the edges of the opening 38 are secured underneath the abutments 42 in such a way that at least the engaging segment 36 of the retaining strap 14 tightly encloses the pair of posts 22 in the engaged position. According to some embodiments the pair of posts 22 comprise abutments 42 which are in this example part of the pair of posts 42. The abutments 42 are present at the outer side of the pair of posts 42 and will allow the opening 38 of the retaining strap 14 to be secured underneath these abutments 42. The retaining strap 14 is slightly deformable. Hence, when the retaining strap 14 is gripped and pulled at to be moved to the engaged position, the opening 38 of the retaining strap 14 slightly enlarges and encloses the pair of posts 22. When the retaining strap 14 is released, the opening 38 slightly decreases in size and causes the pair of posts 22 to be tilted towards each other to tightly secure the catheter 60 (not shown). The abutments 42 prevent the engaging segment 36 of the retaining strap 14 to return to the disengaged position. This way, the retaining strap 14 is tightly held into place by the abutments 42. According to some embodiments the abutments 42 are secured over the edges of the opening 38, holding the retaining strap 14 in the engaged position. The abutment 42 is described in more detail in the application WO 2021/105415 Al.

According to the first aspect of the present disclosure the medical device 10 further comprises a partially engaged position fixing mechanism 44 configured to fix the retaining strap 14 in a partially engaged position, visible in Figs. 7 - 9. When the retaining strap 14 is in the partially engaged position, only one post of at least one of the pair(s) of posts 22 is engaged by the retaining strap 14. The other post is not engaged by the retaining strap 14. As a part of at least one pair of posts 22 is already engaged by the retaining strap 14, after a catheter 60 is placed in the channel 24 it is easier for a health professional to move the retaining strap 14 from the partially engaged position to the engaged position as only one further post of a pair needs to be engaged to move to the engaged position.

According to some embodiments the retaining strap 14 engages one post of only one pair of posts 22 in its partially engaged position. According to some embodiments where the second side 20 comprises two pairs of posts 22 the retaining strap 14 engages one post of only one pair of posts 22 in its partially engaged position. According to a preferred embodiment where the second side 20 comprises at least two pairs of posts 22 the retaining strap 14 engages one post of each of the at least two pairs of posts 22 in its partially engaged position (i.e. only one post of the first pair of posts 22 is engaged by the retaining strap 14, only one post of the second pair of posts 22 is engaged by the retaining strap 14, and only one post of the third pair of posts 22 if present is engaged by the retaining strap 14, etc). According to some embodiments where the second side 20 comprises at least two pairs of posts 22 the retaining strap 14 engages one post of some but not all of the pairs of posts 22 in its partially engaged position (For example, when the second side 20 comprises three pairs of posts 22 the retaining strap 14 may engage one post of one pair of posts 22 or one post of each of two pairs of posts 22 in its partially engaged position). The retaining strap 14 is moveable between the partially engaged position and the engaged position for clamping the catheter 60.

According to some embodiments the retaining strap 14 is moveable between a disengaged position where none of the pair(s) of posts 22 is enclosed by the opening 38, preferably no post is engaged by the opening 38, and the engaged position. Figs. 1 - 6 show some examples when the retaining strap 14 is in the disengaged position. According to some embodiments, as those shown in the Figures, when the retaining strap 14 is in the disengaged position it is connected to the body member 12 by a spine 46. The connecting segment 34 according to some embodiments connects the retaining strap 14 to the body member 12. The engaging segment 36 is farther from the spine 46 compared to the connecting segment 34. The handling segment 40 is farther from the spine 46 compared to the engaging segment 36. The handling segment 40 is for example for manipulating the retaining strap 14 from the partially engaged position and/or from the disengaged position to the engaged position. According to some other embodiments of the medical device, such as the one shown in Fig. 13, when the retaining strap 14 is in the disengaged position it is disconnected from the body member 12. In these embodiments the second side 20 is preferably provided with one pair of posts 22. Alternatively the second side 20 is provided with at least two pairs of posts 22.

Preferably in the partially engaged position the retaining strap 14 is connected to the body member 12 at a coupling location 48. The coupling location 48 is located on the connecting segment 34 of the retaining strap 14. The distal post 30 is farther from the coupling location 48 compared to the proximal post 28. When the retaining strap 14 is in the partially engaged position, the abutment 42 of at least one proximal post 28 engages the retaining strap 14 and none of the distal post(s) 30 engages the retaining strap 14. According to some embodiments the position of the connecting segment 34 remains the same when the retaining strap 14 moves from its partially engaged position to its engaged position. According to some embodiment when the retaining strap 14 moves from its partially engaged position to its engaged position it is not necessary for the health professional to move the entire retaining strap 14: he only needs to move part of the retaining strap 14, for example only needs to move the handling segment 40 of the retaining strap 14, optionally also a part of the engaging segment 36. According to some embodiments, such as the one in Fig. 13, the coupling location 48 is arranged close to at least one of the proximal posts 28. According to one embodiment the coupling location 48 is at least one of the proximal posts 28, for example is all the proximal posts 28. Under these embodiments the retaining strap 14 may be detached from the protrusion 52 when the retaining strap 14 is in the partially engaged position. According to some embodiments the coupling location 48 extends from the protrusion 52 to at least one of the proximal posts 28.

According to the embodiments where the second side 20 comprises one pair of posts 22, as seen in Fig. 13 when the retaining strap 14 is in the partially engaged position the abutment 42 of the proximal post 28 engages the retaining strap 14, and the distal post 30 does not engage the retaining strap 14. According to the preferred embodiments where the second side 20 comprises two pairs of posts 22, the abutment 42 of the proximal post 28 of each pair of posts 22 engages the retaining strap 14 when the latter is in the partially engaged position, and none of the distal post 30 engages the retaining strap 14. Thanks to these features, when a health professional moves the retaining strap 14 to the engaged position, he necessarily has to enclose both pairs of posts 22 with the retaining strap 14. Consequently a potential problem with the medical device in the prior art where in the engaged position the retaining strap sometimes only encloses one pair of posts but not another pair of posts is avoided. More generally when the body member 12 comprises a plurality of pairs of posts 22, when the retaining strap 14 is in the partially engaged position it engages with the abutment 42 of at least two proximal posts 28, preferably the abutment of all the proximal posts 28. With the retainer strap 14 engages at least two proximal posts 28 in the partially engaged position the retailer strap 14 can be maintained in the partially engaged position more solidly. For example, if the retaining strap 14 in its partially engaged position accidentally disengages from a proximal post 28, the retaining strap 14 can still be maintained in the partially engaged position by its engagement with another proximal post 28. Alternatively where the second side 20 comprises two pairs of posts 22, the abutment 42 of the proximal post 28 of only one pair of posts 22 engages the retaining strap 14 when the latter is in the partially engaged position, and the abutment 42 of the proximal post 28 of another pair of posts 22 does not engage the retaining strap 14 and the distal post 30 of the pairs of posts 22 does not engage the retaining strap 14 when the latter is in the partially engaged position.

The handling segment 40 is farther from the coupling location 48 compared to the engaging segment 36.

According to some embodiments the coupling location 48 fixes a fixing length of the retaining strap 14 to the body member, the fixing length being at least 30%, preferably at least 40%, more preferably at least 50%, even more preferably at least 60%, even more preferably at least 70% of the maximal width of the retaining strap 14 measured in the longitudinal direction of the catheter 60.

According to some embodiments such as those shown in the Figures, the partially engaged position fixing mechanism 44 comprises an aperture 50 on the retaining strap 14 and a protrusion 52 on the body member 12 configured to be inserted into the aperture 50 to fix the retaining strap 14 in the partially engaged position. Alternatively the partially engaged position fixing mechanism 44 may comprise an aperture 50 on the body member 12 and a protrusion 52 on the retaining strap 14 configured to be inserted into the aperture 50 to fix the retaining strap 14 in the partially engaged position. The skilled person understands that there are other embodiments for the partially engaged position fixing mechanism 44, such as via a Velcro fastener.

According to a second aspect of the present disclosure the body member 12 comprises an engaged position fixing mechanism 56 configured to fix the retaining strap 14 in the engaged position. The second aspect may be present on the medical device independently from the first aspect. This is to say that a medical device may comprise an engaged position fixing mechanism but does not comprise any partially engaged position fixing mechanism. Such a medical device 10 comprises:

- a body member 12 having a first side 18 adapted to be removably attached to the living creature; a second side 20 opposite the first side 18, the second side 20 provided with at least one pair of posts 22; a channel 24 defined in between the at least one pair of posts 22 and being configured to receive the catheter 60;

- a retaining strap 14 having an opening 38 adapted to enclose and engage said at least one pair of posts 22 to clamp the catheter 60 in an engaged position of said retaining strap 60.

The body member 12 further comprises an engaged position fixing mechanism 56 configured to fix the retaining strap 14 in the engaged position.

According to some embodiments the engaged position fixing mechanism 56 is located farther to the coupling location 48 compared to the at least one pair of posts 22.

The engaged position fixing mechanism 56 is for example located on the handling segment 40 of the retaining strap 14.

According to some embodiments such as those shown in the Figures, the engaged position fixing mechanism 56 comprises a distal loop 58 on the body member 12, for example on the second side 20 of the body member 12. The retaining strap 14 is configured to be inserted into the distal loop 58 to fix the retaining strap 14 in the engaged position. Preferably the handling segment 40 is configured to be inserted into the distal loop 58 to fix the retaining strap 14 in the engaged position, as shown in Figs. 10 - 12.

According to some embodiments the engaged position fixing mechanism 56 is configured to apply a fixing force on the retaining strap 14 greater than the fixing force applied by the at least one pair of posts 22 on the retaining strap 14. Alternatively, the engaged position fixing mechanism 56 is configured to apply an approximately equal or even lower fixing force on the retaining strap 14 compared to the fixing force applied by the at least one pair of posts 22 on the retaining strap 14.

The medical device 10 according to the second embodiment of the present disclosure is shown in Figs. 4 - 6. The diameter of the catheters 60 intended to be received by the channel 24 in the second embodiment is typically comprised between 5 Fr and 11 Fr. The channel 24 is for example V-shaped narrowing towards the second side 20. Other elements of the second embodiment are similar to those of the first embodiment and are not explained here again.

A method of using the medical device 10 as disclosed above to secure a catheter 60 to a living creature will now be described in detail.

First, the retaining strap 14 is in its partially engaged position wherein only one post, for example the proximal post 28, of at least one of the pair(s) of posts 22 is engaged by the retaining strap 14.

Next, a catheter 60 is placed in the channel 24 defined in between the at least one pair of posts 22. Preferably the channel 24 already at least partially immobilises the catheter 60 when the retaining strap 14 is in its partially engaged position and/or disengaged position. Preferably before the catheter 60 is placed in the channel 24 the medical device 10 is moved relative to the catheter 60 to adjust the fixing location of the medical device 10 relative to the living creature.

Then the retaining strap 14 is moved to the engaged position. Optionally a health professional applies a force on the retaining strap 14 in the transverse direction to increase the width of the opening 38 so that the opening 38 slightly enlarges and at least the one distal post 30 can be inserted into the opening 38.

The opening 38 of the retaining strap 14 now encloses and engages the at least one pair of posts 22 to clamp the catheter 60 (not shown in the Figures). The catheter 60 is thus immobilised in the channel 24. It is no longer possible to move the medical device 10 relative to the catheter 60. According to some embodiments the health professional then stops applying the force in the transverse direction, for example he releases the retaining strap 14, so that the opening 38 tightly encloses and engages the at least one pair of posts 22. According to some embodiments when the retaining strap 14 is released the opening 38 slightly decreases in size and causes the pair of posts 22 to be tilted towards each other to secure the catheter 60 tightly in the channel 24.

The body member 12 is then attached to the living creature for example by using an adhesive foil 62. This is carried out for example according to the method disclosed in WO 2021/105415 Al. Alternatively, the body member 12 is attached to the living creature before the retaining strap 14 is moved to the engaged position.

Finally the retaining strap 14 is fixed in the engaged position by the engaged position fixing mechanism 56. Preferably the engaged position fixing mechanism 56 applies a fixing force on the retaining strap 14 greater than the fixing force applied by the at least one pair of posts 22 on the retaining strap 14. The retaining strap 14 is for example inserted into the distal loop 58 of the body member 12 to fix the retaining strap 14 in the engaged position. The catheter 60 is now securely fixed to the living creature.

The present invention is described with respect to particular embodiments and with reference to certain drawings, but the invention is not limited thereto. The drawings, as further described, are only schematic and non-limiting. In the drawings, some of the elements may not be drawn to scale for illustrative purposes. The dimensions and the relative dimensions do not correspond to the actual reductions to practice of the invention.

Furthermore, the terms first, second, further and the like in the description and in the claims are used for distinguishing between similar elements and not necessarily for describing a sequence, either temporally, spatially, in ranking or in any other manner. It is to be understood that the terms so used are interchangeable under appropriate circumstances and that the embodiments of the invention described herein are capable of operation in other sequences than described or illustrated herein.

It is to be noticed that the term “comprising”, used in the claims, should not be interpreted as being restricted to the means listed thereafter; it does not exclude other elements or steps. It is thus to be interpreted as specifying the presence of the stated features, integers, steps or components as referred to, but does not preclude the presence or addition of one or more other features, integers, steps or components, or groups thereof. Thus, the scope of the expression “a product comprising A and B” should not be limited to devices consisting only of components A and B. It means that with respect to the present invention, the relevant components of the product are A and B, and that further components such as C may be present.

Reference throughout this specification to “one embodiment” or “an embodiment” or “some embodiments” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” or “some embodiments” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to one of ordinary skill in the art from this disclosure, in one or more embodiments. Similarly, it should be appreciated that in the description of exemplary embodiments of the invention, various features of the invention are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure and aiding in the understanding of one or more of the various inventive aspects. This method of disclosure, however, is not to be interpreted as reflecting an intention that the claimed invention requires more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive aspects lie in less than all features of a single foregoing disclosed embodiment. Thus, the claims following the detailed description are hereby expressly incorporated into this detailed description, with each claim standing on its own as a separate embodiment of this invention.

Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the following claims, any of the claimed embodiments can be used in any combination.

In the description provided herein, numerous specific details are set forth. However, it is understood that embodiments of the invention may be practised without these specific details.

In other instances, well-known methods, structures and techniques have not been shown in detail in order not to obscure an understanding of this description.

Besides that, when a part of the medical device is said to “inhibit” movement and unless defined otherwise, the term “inhibit” should be interpreted as partially or completely reducing movement. This term may alternatively be referred to as for example: “minimize”, “constrain” or “impede”. Similarly, it is to be noticed that the term “removably attached”, also used in the claims, should not be interpreted as being restricted to direct connections only. The terms “removably attached” and “connected”, along with their derivatives, may be used. It should be understood that these terms are not intended as synonyms for each other. Thus, the scope of the expression “an element A removably attached to an element B” should not be interpreted as elements (e.g. medical device, skin of a patient) being preferably inseparably attached to each other, but rather as an attachment which can be breached by means of a particular pulling force. The term “connected” on the other hand, should be interpreted as describing a coupling between two elements (e.g. base element, body member) which is preferably inseparable. Thus, the scope of the expression “an element A connected to an element B” should be interpreted as an element A being preferably inseparably coupled to element B. The following terms are provided solely to aid in the understanding of the invention. As used herein and unless otherwise specified, when a medical device is said to “secure a medical article to a support”, it is meant that at least a portion of the medical article is fixed to and/or stabilized to and/or positioned onto the support. Securing the medical article typically hinders, or even completely prevents, both translational and rotational movement of at least a portion of the medical article. In the context of the present invention, the term “support” is preferably understood as being a living creature.

As used herein and unless otherwise specified, the term “living creature” is to be understood as the body of a living being, more in particular of human beings or animals. Securing the medical article to the living body advantageously reduces the risk of the medical article moving with respect to the body or even being accidentally removed therefrom.

As used herein and unless otherwise specified, the term “enclose” should be interpreted as to surround or close off an element within a two-dimensional space.

As used herein and unless otherwise specified, the term “tilted” should be interpreted as causing something to move into a sloping or uneven position or to be in this position.

As used herein and unless otherwise specified, the term “engaged position” (may hereinafter also be referred to as “closed position” or “activated position”) should be interpreted as the position which enables an object to exercise its utility, with the opposite of the engaged position being the disengaged position. For example, if the retaining strap is brought into the engaged position while holding a catheter, it is meant that the medical device is clamping the catheter in order to inhibit movement thereof.

As used herein and unless otherwise specified, the term “recess” should be interpreted as a space located further back compared to the surrounding space.

Claims

1. A medical device (10) for securing a catheter (60) to a living creature, comprising:

- a body member (12) having a first side (18) adapted to be removably attached to the living creature; a second side (20) opposite the first side (18), the second side (20) provided with at least one pair of posts (22); a channel (24) defined in between the at least one pair of posts (22) and being configured to receive the catheter (60);

- a retaining strap (14) having an opening (38) adapted to enclose and engage the at least one pair of posts (22) to clamp the catheter (60) in an engaged position of the retaining strap (14), the medical device (10) further comprising a partially engaged position fixing mechanism (44) configured to fix the retaining strap (14) in a partially engaged position wherein only one post of one pair of posts (22) is engaged by the retaining strap (14), the retaining strap (14) being moveable between the partially engaged position and the engaged position for clamping the catheter (60).

2. The medical device (10) according to claim 1, wherein in the partially engaged position the retaining strap (14) is connected to the body member (12) at a coupling location (48), wherein at least one post of at least one of the pair(s) of posts (22) comprises an abutment (42) for fixing the retaining strap (14) in the engaged position, each pair of posts (22) comprising a proximal post (28) and a distal post (30) farther to the coupling location (48) compared to the proximal post (28), wherein in the partially engaged position, the abutment (42) of at least one proximal post (28) engages the retaining strap (14) and none of the distal post(s) (30) engages the retaining strap (14).

3. The medical device (10) according to claim 2, wherein the body member (12) comprises a plurality of pairs of posts (22), wherein in the partially engaged position the retaining strap (14) only engages with at least two proximal posts (28), preferably all the proximal posts (28).

4. The medical device (10) according to claim 2 or 3, wherein the coupling location (48) fixes a fixing length of the retaining strap (14) to the body member, the fixing length being at least 30%, preferably at least 50% of the maximal width of the retaining strap (14) measured in the longitudinal direction of the catheter (60).

5. The medical device (10) according to any of the previous claims, wherein the partially engaged position fixing mechanism (44) comprises an aperture (50) on the retaining strap (14) and a protrusion (52) on the body member (12) configured to be inserted into the aperture (50) to fix the retaining strap (14) in the partially engaged position.

6. The medical device (10) according to any of the previous claims, wherein the body member (12) further comprises an engaged position fixing mechanism (56) configured to fix the retaining strap (14) in the engaged position.

7. The medical device (10) according to claim 6, wherein in the partially engaged position the retaining strap (14) is connected to the body member (12) at a coupling location (48), wherein the engaged position fixing mechanism (56) is located farther to the coupling location (48) compared to the at least one pair of posts (22).

8. The medical device (10) according to claim 6 or 7, wherein the engaged position fixing mechanism (56) comprises a distal loop (58) on the body member (12), the retaining strap (14) being configured to be inserted into the distal loop (58) to fix the retaining strap (14) in the engaged position.

9. The medical device (10) according to any of claims 6 to 8, wherein the engaged position fixing mechanism (56) is configured to apply a fixing force on the retaining strap (14) greater than the fixing force applied by the at least one pair of posts (22) on the retaining strap (14).

10. The medical device (10) according to any of the previous claims, wherein the body member (12) comprises a gap (32) arranged at the height of the transition between the pair(s) of posts (22) and the second side (20) of the body member (12) for partially disconnecting the pair(s) of posts (22) and the body member (12) to enable the pair(s) of posts (22) to be tilted towards each other in the engaged position independently from the body member (12).

11. The medical device (10) according to any of the previous claims, wherein the pair(s) of posts (22) inhibits at least a longitudinal movement of the catheter (60) along the channel (24) in the engaged position.

12. A kit comprising the medical device (10) of any of the previous claims, a catheter (60) and optionally an adhesive foil (62).

13. A method of using a medical device ( 10) to secure a catheter (60) to a living creature, the medical device (10) comprising a body member (12) and a retaining strap (14), the body member (12) comprising at least one pair of posts (22), the catheter (60) being located in a channel (24) defined in between the at least one pair of posts (22) while the retaining strap ( 14) is in a partially engaged position wherein only one post of one pair of posts (22) is engaged by the retaining strap (14), the method comprising the step of: - moving the retaining strap (14) to an engaged position where an opening (38) of the retaining strap (14) encloses and engages the at least one pair of posts (22) to clamp the catheter (60).

14. The method according to claim 13, further comprising, after moving the retaining strap (14) to the engaged position, the step of fixing the retaining strap (14) in the engaged position by an engaged position fixing mechanism (56), wherein preferably the engaged position fixing mechanism (56) applies a fixing force on the retaining strap (14) greater than the fixing force applied by the at least one pair of posts (22) on the retaining strap (14).

15. The method according to claim 14, wherein after moving the retaining strap (14) to the engaged position and before fixing the retaining strap (14) in the engaging position by the engaged position fixing mechanism (56), the method further comprises the step of attaching the body member (12) to the living creature.