WO2019185511A1

WO2019185511A1 - Plug and plug system for contacting a cable with an implantable device, and contacting method

Info

Publication number: WO2019185511A1
Application number: PCT/EP2019/057380
Authority: WO
Inventors: Thomas Alexander Schlebusch
Original assignee: Kardion Gmbh
Priority date: 2018-03-27
Filing date: 2019-03-25
Publication date: 2019-10-03
Also published as: DE102018204604A1

Abstract

The invention relates to a plug (100) for contacting a cable (300) with an especially implantable device (500), wherein the plug (100) has a flexible plug part (110), a cavity (120) for receiving a pin (200) for reinforcing the plug part (110). The invention further relates to a plug system comprising such a plug (100) and a pin (200) for reinforcing the plug and to an associated method (600).

Description

description

title

Plug and plug system for contacting a cable with an implantable device and method for contacting

State of the art

From the prior art, the application of four-pin connector standards IS-4 and DF4 according to DIN ISO 27186 for contacting implantable

Pulse generators are known, for example, as proprietary modifications described in US 2014/0107754 Al and US 2014/0135884. In addition, 1- and 2-pin plug variants in accordance with ISO 11318 and ISO 5841-3 1- and 2-pin plug variants for implants can be used. The plug must be made rigid in order to forward the force to the spring contacts when plugging in and thus be able to be successfully introduced into the spring contact socket, in particular without kinking.

Disclosure of the Invention Advantages of the Invention

Against this background, the invention relates to a plug for contacting a cable with a particular implantable device. The plug has a flexible plug part with a cavity for receiving a pin for stiffening the plug part.

The implantable device may in particular be a device which is designed to be operated in the body of a living being, for example a cardiac support system, also called a ventricular assist device (abbreviated to VAD), or an implantable pulse generator, for example a cardiac pacemaker. However, the invention is not limited to implantable devices, but is suitable for all applications in which a particular high-pin connector due to spatial

Requirements during cable routing must be bent, for example, to pass through tight bends.

In particular, the plug can be a plug based on DIN ISO 27186, ie a plug which partially or preferably completely fulfills the requirements of DIN ISO 27186. The plug is preferably connected to a cable or forms part of the cable to electrically connect the cable to the implantable device. Preferably, the plug has at least one electrical contact for electrically contacting the cable with the implantable device. The at least one electrical contact is arranged in particular in the form of a ring, a ring segment, a band or a band segment around the plug, in particular around the plug part. In particular, the plug may have a plurality of electrical contacts, which are arranged along the plug separated by isolation zones around the plug.

Under a plug part is a part of the plug to understand, for example, a portion of the plug. At the pin, in the further also stiffening pin In particular, it may be a rod-shaped object which has a predetermined rigidity, that is to say has a predetermined resistance to bending. For example, the pin can be made of plastics and / or metals. Despite the stiffness of the pin is preferably not brittle to avoid breaking the pin under stress. Under the cavity can be understood a cavity, in particular a shaft-shaped recess in the plug part, for example a cylindrical recess. Pen and cavity are preferably coordinated in their dimensions to one another such that the pin can be inserted by a human user without much effort in the cavity and is held therein due to static friction between the pin and a wall of the cavity. If a wall of the cavity comprises elastic material, the pin may preferably have a larger cross section than the cross section of the cavity, so that the pin is held in the cavity due to a restoring force of the elastic material. Depending on the elasticity of the material and a desired holding force acting on the pin, the relative sizes of the cross sections can be selected relative to each other.

The connector according to the invention has the advantage that it has a high flexibility on the one hand on the flexible connector part and on the other hand can be stiffened if necessary by receiving the pin. This is particularly advantageous when the plug must be moved in an application through narrow and / or curved spaces, in particular when implanted in a body of a living being. In this case, the plug can advantageously be initially introduced in its flexible form to the device and only be stiffened immediately before the connection to the device by the insertion of the pin. The stiffening has the advantage that a power transmission from the user via the connector can be done on the device effectively. Thus, despite its flexibility, the plug can be comfortably contacted with the device.

In a particularly advantageous development of the invention, the cavity has a narrowing area lying opposite an opening in the cavity. In such a region, a tapered part of the stiffening pin can be accommodated, which has the advantage that the effect the stiffening can be reduced depending on the degree of rejuvenation. Preferably, the constriction is a continuous or continuous constriction or rejuvenation.

According to a particularly preferred development, the narrowing region of the cavity extends at least partially into the cable. This has the advantage that the stiffening effect of the stiffening pin can extend into a region of the cable adjacent to the plug. This advantageously prevents unwanted kinking of the cable near the plug.

In an advantageous embodiment, a circumference of the plug continuously merges into a circumference of the cable. In this case, a circumference is to be understood in particular as an outer surface or lateral surface of the plug or of the cable. This has the particular advantage that the plug with cable can be passed through a narrow location, without that in the

Feed the connectors or catch the cable. In particular, the plug and the cable have an equal width of the cross section. Alternatively, an outer surface of the plug is connected via a chamfer to an outer surface of the cable. In other words, an outer surface or a circumference of the plug transitions over the chamfer continuously into an outer surface or a circumference of the plug.

The invention also relates to the pin for receiving in the cavity of the plug according to the invention. Preferably, as described above, the pin comprises a tapered end. The tapered end can serve in particular as kink protection for the cable connected to the plug.

The invention furthermore relates to a plug system comprising a plug according to the invention and a pin according to the invention.

According to a particularly preferred development, the plug system comprises a further pin, in particular a plug, as a placeholder in the

Cavity of the plug part, wherein the further pin has a higher flexibility than the stiffening pin. This has the advantage that before introduction of the Stiffening pin the cavity is protected by the further pin from contamination.

Preferably, the pin and / or the further pin comprise at one end a handle, in particular an eyelet. This advantageously facilitates the removal of the pin or the other pin from the plug. According to an advantageous embodiment, the handle comprises a magnet for

Interaction with a magnetic iron.

In a particularly advantageous development, the pin and / or the further pin on a projection or a recess for a positive connection with the plug part. This has the advantage that the pin or the other pin can be temporarily fixed with the plug. This fixation is also advantageously immediately recognizable to the user, as a force application to pull out the pin is many times higher than the force to insert the pin. The projection may for example have the form of a latching nose or a barb. If the cavity has such a projection, the recess of the pin may preferably comprise a complementary form for the positive connection, in particular a latching nose or a barb.

The invention also provides a method for connecting the

plug according to the invention with a device, in particular with an implantable device. In a first step of the process, the

Stiffening pin inserted into the cavity of the flexible connector part of the connector for stiffening the connector part. In a second step, the plug is connected to the device for contacting the cable with the device. Preferably, the plug may be passed through a sluice prior to insertion of the stiffening pin, for example through a sluice of a device or a blood vessel. If the plug comprises the further pin or plug, the further pin or the plug is removed from the plug before inserting the stiffening pin.

For the advantages of the method according to the invention reference is made to the above-mentioned corresponding advantages. Brief description of the drawings

Embodiments of the invention are shown schematically in the drawings and explained in more detail in the following description. The same reference numerals are used for the elements shown in the various figures and similarly acting, wherein a repeated description of the elements is dispensed with.

Show it

Figure 1 shows an embodiment of the invention

Plug system comprising an embodiment of the plug according to the invention,

Figure 2 shows another embodiment of the invention

Plug with a placeholder pin and

Figures 3 to 4 an embodiment of the method according to the invention. Embodiments of the invention

FIG. 1 shows an exemplary embodiment of a system 1000 according to the invention comprising an exemplary embodiment of a plug 100 according to the invention and an exemplary embodiment of a pin 200 according to the invention.

Figure la shows schematically the embodiment of

plug 100 according to the invention in a perspective view. The plug is connected to a cable 300 or forms part of the cable 300, in particular an end piece 301 of the cable 300. The plug 100 comprises electrical contacts 170 for electrically contacting the cable 300 with the device, in particular an implantable device such as an implantable part a heart support system. The electrical contacts 170 can thereby, as shown in the form of rings or ring segments be arranged alternately with isolation zones 180 around the plug part 100. As shown in FIG. 1c, a connection to the electrical contacts 170 can take place via electrically conductive wires 171 in a lumen 310 of the cable 300. Preferably, in this case, there is a barrier 320 between the cavity 120 and the lumen 310 of the cable 300 as corrosion protection to prevent liquid from entering the lumen 310 from the cavity 120. This can be achieved, for example, by first guiding the lumen 310 from the cable 300 into the plug 100, then filling the lumen 310 and, via an embossing tool, the cavity 120 for the lumen 310

Stiffening pin 200 is impressed in the plug 100.

As shown in FIG. 1 a, the outer surface 102, in other words the circumference, of the plug 100 continuously merges into an outer surface 302 or circumference of the cable 300, in the present example even without changing the width of the cross section. Alternatively, with a different cross-sectional width, a chamfer may be provided for the continuous transition. For example, the plug 100 has a cross-sectional width 103, in other words a diameter 103, between 1 and 10 millimeters, preferably between 2 and 4 millimeters.

The plug 100 comprises a flexible plug part 110 with a cavity 120 for receiving a pin for stiffening the plug part. As shown in Figure 1, the cavity 120 is accessible via a front side 101 of the plug. The cavity 120 preferably forms a cavity

for example, round or oval cross section 123, wherein the cross section 123 may have a diameter of 0.1 to 8 millimeters, preferably between 0.3 and 1 millimeter. The plug 100 may be at least partially made of the same material as the cable 300 and include, for example, a silicone material.

Figure lb shows schematically the embodiment of the pin 200 according to the invention in a longitudinal sectional view. The pen 200 includes three areas. A preferred grip region 201 adjoins a stiffening region 202, wherein the stiffening region 202 adjoins a preferred kink protection region 203 adjoins. The kink protection region 203 is preferably a tapered extension of the stiffening region 202.

Figure lc shows how the pin 200 is already partially in the cavity 120 of the plug 100. The cavity 120 has at the opening 102 of the cavity 120 on the front side 101 opposite side 102 a narrowing in the form of a taper 122, which is preferably adapted to the taper of the kink protection area 203. The cavity 120, in particular the taper 122 of the cavity 120, may preferably extend beyond the plug 100 into the cable 300 so that the cable 300 is also partially protected against kinking. Depending on how strong the transition region between plug and cable should be bendable, the degree of taper of the cavity 120 and / or the degree of taper of the kink protection region 203 may be formed. In other words, a bending radius for bending the cable 300 downwards may be limited by the degree or thickness of the taper. Preferably, the dimensions of the cavity 120 and the pin 200 may be selected so that the kink protection area 203 is no longer in the plug 100 but completely in the cable 300 adjacent thereto when the pin 200 is fully inserted into the cavity 120. Furthermore, it is shown in FIG

Diameter 204 of the handle portion 201 is preferably adapted to the cross-sectional width 103 of the plug and preferably the same size, so that along the outer surface 102 at the junction between the plug 100 and plugged pin 200 is no jump in cross-section, resulting in insertion of the plug 100 with recorded pin 200th would complicate in a socket. In an advantageous embodiment, at least one wall 124 bounding the cavity 120 comprises elastic material, for example an elastomer, so that a frictional connection with the received pin 200 is possible. For such a frictional connection, the diameter 205 of the pin can be chosen to be slightly larger than the diameter 123 of the cavity 120, depending on the elasticity of the elastic material and depending on the desired strength of the frictional connection.

The stiffening pin 200 preferably comprises flexurally elastic material, so that in particular movements in the kink protection area 203 without breakage can be included. For example, the pin 200 may include polymers such as polyethylene, ethylene tetrafluoroethylene, fluoroethylene propylene,

Polyhydroxyalkanoate, polyhydroxybutyrate, polyurethane or even polycarbonate and epoxy resins. Alternatively or additionally, the pin 203

Nickel-titanium shape memory alloy, short NiTiNol, include, which is characterized by high flexibility. Other alternatives include stainless steel and titanium. The length and stiffness of the stiffening pin 200 should be selected in accordance with the stiffness of the material of the plug 100 and the cable 300 so that when grasping the transition between the plug 100 and the cable 300 a force up to 4.5 Newton, preferably up to 16 Newton, on the

Transition can be exercised without a kinking of the cable 300 takes place (DIN ISO 27186). The grip area 201 of the pin 200 preferably has a length that makes it possible to hold the stiffening pin 200 thereon, for example between 1 and 10 millimeters, in particular between 2 and 4 millimeters. The kink protection region 203 has, for example, a length of between 1 and 30 millimeters. Preferably, the total length of the stiffening region 202 and kink protection region 203 corresponds to the length of the cavity, so that the stiffening region 202 and kink protection region 203 can be completely accommodated in the cavity 120 and completely fill the cavity 120 lengthwise. More preferably, this overall length is somewhat, for example 1 to 2 millimeters, longer than the length of the cavity 120. This has the advantage of allowing a user to easily feel the resulting gap between pin 200 and plug 100 and thus more easily remove the pin 200 from the plug 100 can solve. The gap may be partially, almost completely or completely filled with a material, in particular a particular tearable adhesive to allow blood to penetrate into the gap or a

Hooking in a passage through a bottleneck, such as a lock to prevent.

FIG. 2 shows an example of an embodiment of the invention

Inventive system 1000 comprising a further pin 400. The further pin 400 can advantageously be used as a placeholder in the cavity 120 of the connector part 100. The further pin 400 has a higher flexibility than the pin 200 for stiffening. Preferably, the portion 401 of the pin 400, which received in the cavity 120 of the plug is to be the same or a very similar shape as the stiffening pin 200 on. As a result, the further pin 400 preferably also completely fills the cavity 120 lengthwise, and preferably forms the above-described gap 50 to the plug 100 when fully received, as shown in FIG. The further pin 400 may likewise have a grip region 410 in the form of a handle 410, in particular an eyelet. Alternatively, the handle portion 410 may include a magnet 411 for interaction with a magnetic hinge. As shown in Figure 2, the further pin may have a projection 405 or a recess for a positive connection with the plug part 100. Preferably, the form-fitting, so in particular a projection and an associated recess, between the plug part 100 and the further pin 400 is designed so that the further pin 400 can be separated from the plug part when a predetermined force, for example between 10 and 20 Newton is exceeded. The pin 200 for stiffening may also have such a projection 405 or recess for a positive connection with the plug 100. Alternatively or additionally, a temporary connection between the pins 200, 400 and the plug 100 can be made by gluing.

FIG. 3 shows by way of example a use of the system 1000 according to the invention in connection with a cardiac assist system. FIG. 3 a shows how the plug 100 with cable 300 is located in a blood vessel 10, in particular in the aorta, and is to be pulled out of the blood vessel through a sluice 11 in the blood vessel 10. In this case, the plug 100 includes, for example, the further pin 400 described above, which can be pulled through the lock 11 with a tang 30, for example a magnetangel, as shown in FIG. 3b. Before that, the plug 100 can be advanced, for example, with the aid of a femoral access catheter to close to the lock 11, which facilitates the use of the tang 30. After the plug 100 has been passed through the lock 11, the further pin 400 can be removed and replaced by the stiffening pin 200, as indicated in Figure 3c. Subsequently, the stiffened by the pin 200 plug 100 in a contact socket 510 of another part 500 or device 500 of

Cardiac support system can be inserted, as shown schematically in Figure 4d. In the same way, the flexible connector 100 can also by a Passed lock 11 of a device and then stiffened over the stiffening pin 200.

FIG. 3 thus also shows an exemplary embodiment of the method 600 according to the invention for connecting the plug 100 to a device 500, in particular to an implantable device 500. FIG. 4 shows a flow chart for this purpose. In a first step 601 of the method 600, the pin 200 is inserted into the cavity 120 of the flexible plug part 110 of the connector 100 for stiffening the plug part. In a second step 602, the plug 100 with the device 500 for contacting the cable 300 with the

Device 500 connected. As described above, prior to insertion 601 of the pin 200, the plug 100 may be passed through a sluice 30 in a preparation step 601a.

Claims

claims

1. plug (100) for contacting a cable (300) with a particular

implantable device (500), characterized in that the plug (100) has a flexible plug part (110), with a cavity (120) for receiving a pin (200) for stiffening the plug part (110).

2. Plug (100) according to claim 1, wherein the plug (100), in particular the

Plug part (110), at least one electrical contact (170) for electrically contacting the cable (300) with the implantable device (500), wherein the at least one electrical contact (170) preferably in the form of a ring (170) or a ring segment ( 170) is arranged around the plug (100).

3. Plug (100) according to one of the preceding claims, wherein a cavity (120) delimiting wall (100) comprises elastic material, in particular for a frictional connection with the male pin (200).

4. Plug (100) according to any one of the preceding claims, wherein the cavity (120) opposite to an opening (121) in the cavity (120) lying, narrowing region (122).

5. plug (100) according to claim 4, wherein the narrowing region (122)

extends at least partially into the cable (300).

6. Plug (100) according to one of the preceding claims, wherein the plug (100) is connected to a cable (300) or forms a part (301) of a cable (300).

7. plug (100) according to claim 6, wherein a circumference (102) of the plug (100)

continuously merges into a periphery (302) of the cable (300), for example via a chamfer.

8. pin (200) for accommodating in the cavity (120) of a plug (100) according to one of the preceding claims for a stiffening of the plug (100)

The pin (200) of claim 8, wherein the pin (200) has a tapered end (203).

10. plug system (1000) comprising a plug (100) according to any one of claims 1 to 7 and a pin (200) according to claim 8 or 9.

11. Plug system (1000) according to claim 10, further comprising a further pin (400), in particular a plug, as a placeholder in the cavity (120) of the plug part, wherein the further pin (400) has a higher flexibility than the pin (200). for stiffening.

12. Plug system (1000) according to claim 10 or 11, wherein the pin (200) and / or the further pin (400) at one end a handle (201, 410), in particular an eye, or a magnet (411) for interaction having a magnetangel

13. Plug system (1000) according to one of claims 10 to 12, wherein the pin (200)

and / or the further pin (400) has a projection (405) or a recess (405) for a positive connection with the plug part (110).

14. Method (600) for connecting a plug (100) to a device (500),

in particular with an implantable device (500), comprising the steps:

• inserting (601) a pin (200) into a cavity (120) of a flexible plug part (110) of the plug (100) for stiffening the plug part (110).

• connecting (602) the plug (100) to the device (500) for a

Contacting a cable (300) with the device (500).

15. The method of claim 14, wherein prior to insertion of the pin, the plug is guided through a lock.