Connector assembly for implantable devices

Abstract

A connector assembly (100) for connecting external power sources to an implanted medical device has a distal driveline portion (102) and a proximal driveline portion (101), each comprising a plurality of isolated electricity wires (103) and at least one load carrying wire (104). An intermediate driveline assembly (300) is provided and adapted to arrange the electricity wires (103) and the load carrying wire(s) (104) in a flat plane (13) for a predetermined distance (11) in the longitudinal direction (10) of these wires (103, 104), wherein the electricity wires (103) and the load carrying wire(s) (104) are positioned in a spacing from each other over at least a part of this predetermined distance (11') in that plane (13).

Description

[0001] 2022-153

[0002] 1

[0003] TITLE

[0004] CONNECTOR ASSEMBLY FOR IMPLANTABLE DEVICES

[0005] TECHNICAL FIELD

[0006] The present invention relates to a connector assembly for implantable devices, especially for connecting external power sources to an implanted medical device with a distal driveline portion and a proximal driveline portion. A method of positioning a connector assembly for connecting implantable devices through the skin of a patient is also disclosed.

[0007] PRIOR ART

[0008] Ventricular Assist Devices (VAD) need electrical power. Power transfer to VADs involves thick percutaneous drivelines that create a chronic wound on the human skin. This clinical challenge endangers the outcome of VAD therapy due to the life-threatening risk of driveline infection (DLls). Two articles from de By et al in “The European Registry for Patients with Mechanical Circulatory Support of the European Association for Cardio-Thoracic Surgery: third report” in Eur J Cardiothorac Surg, 2022. 62(1) as well as Mehra et al in “Five-Year Outcomes in Patients With Fully Magnetically Levitated vs Axial-Flow Left Ventricular Assist Devices in the MOMENTUM 3 Randomized Trial” in the Journal of American Medical Association (JAMA, 2022. 328(12):1233-1242) note that DLls is a leading postsurgical complication in VAD therapy, causing frequent readmission and patient death. Moreover, competitive experimental protocols with fully implantable VADs using wireless power transfer have not been adopted by clinicians due to safety risks associated with thermal injury, loss of device communication, short battery lifetime, and low biocompatibility as explained by Robert J.H. Miller et al. in "Innovations in Ventricular Assist Devices for End- Stage Heart Failure" in Annu.Rev.Med. 2019. 70:33-44.

[0009] Such drivelines can also be used for different implantable devices as diagnostic implants and even batteries or accumulators could be attached to such a driveline or being the terminal part of it. On the outside of the patient, it does not have to be only a power source 2022-153

[0010] 2 as connected device but can also be an external medical device or diagnostic device.

[0011] WO 2014 / 179391 A2 discloses a connector assembly for connecting an external electrical device to an implanted device. The connector assembly comprises a first electronic supply line coming from the heart and having an extracardiac portion ending in a connector. A second electronic supply line connects directly a control apparatus outside the body of a patient with this first electronic supply line. This second electronic supply line thus comprises a first portion guided in the subcutaneous tissue and a second extracorporal portion. Nothing specific in these portions is provided at the transition from inside to outside the body.

[0012] WO 2011 / 156391 A1 discloses a connector assembly for connecting an external electrical device to an implanted device. The connector assembly comprises two first electronic supply lines coming from the heart and having each an extracardiac portion ending in a connector. A Y-shaped connector connects to the connectors of the two first electronic supply lines and combines them into one single line providing an end of this combined first supply line. A second electronic supply line connects directly a control apparatus outside the body of a patient with this combined end of the first electronic supply line. This second electronic supply line thus comprises a first portion guided in the subcutaneous tissue and a second extracorporal portion. Nothing specific in these portions is provided at the transition from inside to outside the body.

[0013] US 2017 / 324185 A1 discloses a connector assembly for connecting an external electrical device to an implanted device. The implanted device comprises a controller assembly connected to a blood pump in the vicinity of a heart of a patient and has a connector in its case body. There is only one electronic supply line connecting directly a control apparatus outside the body of the patient with this connector in the case body. This electronic supply line thus comprises a first portion guided in the subcutaneous tissue and a second extracorporal portion. Nothing specific in these portions is provided at the transition from inside to outside the body.

[0014] The last three mentioned prior art documents all describe connector assemblies between distal and proximal driveline portions establishing connections under the skin. The connection points and the driveline portions comprise a plurality of cables arranged in the longitudinal direction. From these connector assemblies, a portion of a single driveline exit the skin percutaneously, establishing a single exit site on skin to connect with external 2022-153

[0015] 3 devices.

[0016] SUMMARY OF THE INVENTION

[0017] It is an object of the invention to relieve the pressing clinical challenge of driveline infections (DLls) when implantable medical devices are to be connected through the skin of a human or animal patient. Such DLLs can e.g. happen when Ventricular assist devices (VADs) are implanted which lead to rehospitalization and reduced survival rate in patients with advanced heart failure (HF).

[0018] The object is achieved with the assembly with the features of claim 1 . It combines a solution to translate wire technology into a procedural package of device components and surgical tools for safe power transfer to VADs.

[0019] Advantages of the inventions are - inter alia - providing a minimum number, length, size of wires to satisfy the required power for VADs. Furthermore, the invention allows to use materials and surgical tools to enable the safe implantation of thin conductive wires by straightforward, minimally invasive options. This can be realized in preferred embodiments i) by a surgical tunneler that acts through the open chest of the patient in the operating room and ii) a guide system that directs the implantation of the energy transfer device through a skin scission that facilitates positioning and quick wound closure by suturing.

[0020] This can be combined with a) features to secure an electrical connection of the implanted wires in single-step click manner, and b) a protective cap with skin-compatible materials for the mechanical protection of the electrical connection and the antibacterial protection of the underlying skin wound.

[0021] The type of conductive wires is open to use of different metallic materials and alloys with the only limitation of a maximum diameter to minimize adverse tissue reactions. Likewise, different type of silicone or other chemistry coatings for mechanical protection and biocompatibility can be used. Materials for the design of an implantation tunneler, the electrical connection, and a complementary protective cap should be biocompatible or FDA approved materials to limit the risk of infection or injury.

[0022] The present invention is not based on wireless methods for power transfer negating the 2022-153

[0023] 4 problem of inconsistency and tissue injury associated with the wireless transfer of large amounts of power through the human body.

[0024] A connector assembly for connecting an external electrical device with a distal driveline portion to an implanted device with a proximal driveline portion is configured to connect a plurality of cables in these portions. The connector assembly comprises an intermediate driveline assembly providing this connection. The intermediate driveline assembly is adapted to arrange the cables for a predetermined distance in the longitudinal direction of these cables. The cables are positioned in a spacing from each other over at least a part of this predetermined distance.

[0025] It is noted that the term "a cable" comprises isolated electricity wires or load bearing cables. One cable can also comprise more than one e.g. two or three isolated electricity wire, optionally intertwined with a load bearing wire. It is an object of the invention to separate a "thick" driveline into a plurality of spaced apart cables for the passage of the skin. It is not mandatory that each passage for a cable only comprises one isolated electricity wire or one load bearing wire. It can also comprise several wires. In other words, each of the cables comprises at least one isolated electricity wire or at least one isolated electricity wire with a load bearing reinforcement or a load carrying wire. The advantage of small holes is even present if two wires in contact are bundled together. They can have a total diameter of ~1 mm, three wires in contact give ~1.5 mm. This is much smaller than today’s VAD drivelines, especially area wise, since it changes with the square of the radius. If they are electrical wires and attached to one common needle, they can still be connected one-by-one after having passed the skin through manual contacting.

[0026] The spacing between two of the wires for said part of the predetermined distance is the distance of the outer surface of one wire to the outer surface of the adjacent wire. This distance is preferably at least equal to the diameter of the thinner of these wires. Wires can have different diameters for various reasons as i.) electricity wire vs. thicker load bearing wire or vice versa, ii.) isolated electricity wire vs. isolated electricity wire with reinforcement or iii.) group of two or three zero-spaced wires vs. an adjacent single isolated electricity wire or load bearing wire. With an electricity wire having a diameter of e.g. 0.5 mm to 1 mm, it is nevertheless preferred to have a spacing of at least 1 mm, preferably 2 mm to 5 mm or if larger distances are possible up to 2 cm. With a spacing of 2 mm and seven wires with an average diameter of 1 mm, the total width of the unfolded wires of such an embodiment is about 19 mm. 2022-153

[0027] 5

[0028] The intermediate assembly can be disconnected from the connected parts proximally and distally, i.e. with the implantable or implanted devices, batteries or accumulators or with an external power source or an external medical device or diagnostic device. They can then be replaced or substituted by dedicated surgical action.

[0029] The cables, i.e. wires or grouped wires can be arranged in the longitudinal direction in a flat plane. This enables to pass them through the skin with one opening in the skin and then the cables are sutured side by side, closing the gaps in between.

[0030] In a different embodiment, it is also possible to push a plurality of needles through the skin with a cable attached to each needle, wherein each cable can also comprise two or more wires which are individually connected to the distal driveline outside (or inside; see below) the skin.

[0031] In a further different embodiment, the cables are arranged in the longitudinal direction in a circular or elliptical plane with one or two optional central cables which modifies the above embodiment by a different arrangement of the needles in a circular or elliptical disposition. The above mentioned spacing is then applied to each of the adjacent wires in the circle and / or from the wires on the circle to the central wire.

[0032] In such a case, it is also possible to provide the needles and as such the passages in one or more parallel, especially flat planes.

[0033] When the cables are to be individually sutured at the passage of the skin, the intermediate driveline assembly can comprise a sheath enveloping the folded cables as well as an unfolding unit at both ends of the sheath adapted to unfold the cables folded within the sheath. The sheath can be a wrapping, especially a helicoidal wrapping, which can be removed when the connector is used or the wrapping or sheath remains attached and is positioned near the passage of the skin under the skin. A folded structure can be a helical structure where cables are rotated in one single direction, or only the middle part of the plurality of cables are rotated in one direction while the ends of the plurality of cables is maintained in its initial position.

[0034] Another embodiment of the intermediate driveline assembly avoids the use of a sheath enveloping the cables and just provides continuously running cables one beside the other. 2022-153

[0035] 6

[0036] The cables can also be folded cables, i.e. folded together.

[0037] The intermediate drive assembly can comprise an unfolding or spreading unit at both of its ends adapted to separate and spread the cables into the separated condition.

[0038] The unfolding unit can comprise at each of its ends an essentially triangular flexible flap with the smaller portion directed to the distal driveline portion and the proximal driveline portion, respectively, at which smaller portion the cables, i.e. the isolated electricity wires and load carrying wire(s), enter the triangular flexible flap, wherein the cables are guided in the flexible silicone flap towards the larger portion where the cables are positioned in said required spacing from each other over the part of this predetermined distance in that plane.

[0039] The flexible flap has a smaller end portion and a larger end portion. The tapered section between the smaller end portion and the larger end portion of the flexible flap has not necessarily the above mentioned triangular shape. The shape can be trapezoid, following a polygon or be a curved shape. It has the shape to spread the bundled cables from the small end into separated cables at the larger end. Inside the flexible flap can be provided cavities to store portions of the cables, e.g. in loops.

[0040] The flexible flap can also have the property of initially being compressed (optionally with the sheath) and then expanding symmetrically or non-symmetrically in the radial direction. This more three-dimensional representation enables the flap to be a spot for cable storage / strain relief / on top of just spacing the cables in the lateral and longitudinal direction.

[0041] The flexible or elastic flaps can be made of silicone or other resilient materials allowing for unfolding into their original flat triangular shape.

[0042] A further embodiment is characterized by claim 12, wherein a tunneler adapted to maintain the needles inside a guide and upon pushing a pushing unit of an activation rod they are pushed outside the tunneler through the skin. Connecting units are within the proximal side part of a distal connection block to fixate and contact the electricity wires. Load carrying wires are connected with fixating units.

[0043] The tunneler can also be used to push the needles from outside the skin under the skin; the distal connection block is then to be positioned under the skin.

[0044] In the embodiment using a tunneler as shown in the drawings the activation rod comprises 2022-153

[0045] 7 a pulling unit which allows to raise the proximal connection block against the plane of the tunneler to activate the pulling unit afterwards to push the needles through the skin. This embodiment is adapted to be used from under the skin of a human or animal patient to be pushed through the skin to the outside.

[0046] The needles are catched by a distal connection block, which can comprise connecting units to connect the electricity wires with electrical contacts and load bearing / carringy wires wit fixating units to immobilise the connection.

[0047] The percutaneous drivelines as disclosed in the prior art all establish a single exit site from the skin. The connector assembly according to the invention establishes multiple exit sites equal to the number of isolated wires in the driveline through the skin. Furthermore, none of the percutaneous drivelines as disclosed in the prior art describe the use of a load bearing wire as part of their cable plurality.

[0048] Further embodiments of the invention are laid down in the dependent claims.

[0049] BRIEF DESCRIPTION OF THE DRAWINGS

[0050] Preferred embodiments of the invention are described in the following with reference to the drawings, which are for the purpose of illustrating the present preferred embodiments of the invention and not for the purpose of limiting the same. In the drawings,

[0051] Fig. 1 shows a schematical perspective and partial exploded view of an assembly according to a first embodiment of the invention;

[0052] Fig. 2 shows a schematical perspective view of the unfolded wires of the embodiment of Fig. 1 and at the same time it shows an independent modification of this embodiment;

[0053] Fig. 3 shows the schematical perspective view of Fig. 2 in connection with the implanting situation with a patient;

[0054] Fig. 4 shows a partial detailed view relating to suturing the wound as shown in Fig. 3;

[0055] Fig. 5 shows a schematical and partial transparent perspective view of the proximal portion of an assembly according to a second embodiment of the invention;

[0056] Fig. 6 shows a schematical and partial transparent perspective detail view of Fig. 5 with the pivotable front part raised; 2022-153

[0057] 8

[0058] Fig. 7 shows the view of Fig. 6 when the needles are pushed out of the pivotable front part;

[0059] Fig. 8 shows a schematical and partial transparent perspective detail view of the slidable glide with pushed-out needles as in Fig. 7;

[0060] Fig. 9 shows a schematical and partial transparent cross-section detail view of the slidable glide with pushed-out needles as in Fig. 8;

[0061] Fig. 10 shows a schematical and partial transparent cross-section view of the positioned tunneler after raising the glide and before pushing the needles out;

[0062] Fig. 11 shows a schematical perspective view of the distal connection block of the intermediate drive assembly according to the second embodiment;

[0063] Fig. 12 shows a schematical and partial transparent cross-section detail view from above on the proximal side part of the distal connection block of Fig. 11 ;

[0064] Fig. 13 shows a schematical cross-section detail view from the side on the proximal side part from Fig. 11 and Fig. 12 at a plane cutting through one of the electricity wires;

[0065] Fig. 14 shows a schematical cross-section detail view from the side on the proximal side part from Fig. 11 and Fig. 12 at a plane cutting through one of the load bearing wires;

[0066] Fig. 15 shows a schematical perspective view of the distal connector of the intermediate drive assembly according to the second embodiment; and

[0067] Fig. 16 shows a schematical and partial transparent perspective view of the proximal portions of the intermediate drive assembly according to the second embodiment with the needles pushed out, traversing the distal connection block and pulling the additional length out by moving the distal side silicone part away from the skin and needle crossing area.

[0068] DESCRIPTION OF PREFERRED EMBODIMENTS

[0069] Fig. 1 to Fig. 4 shows a first embodiment of a connector assembly 100 as well as a modification of this first embodiment; and Fig. 5 to Fig. 16 shows a second embodiment of a connector assembly 200. The connector assembly 100 for connecting external power sources to an implanted medical device (not shown) has a distal driveline portion 102 and a proximal driveline portion 101. Both driveline portions comprise isolated electrical wires 103 and load carrying wires 104 which are preferably intertwined. In the embodiment as shown in the Figs, each cable of the plurality of cables of the driveline comprises a single 2022-153

[0070] 9 isolated electrical wire 103 and load carrying wire 104. Fig. 1 shows the intermediate driveline assembly 300 comprising the twisted and folded wires 103 and 104 extending between the distal driveline portion 102 and the proximal driveline portion in the longitudinal direction 10 of the driveline. The intermediate driveline assembly 300 comprises an unfolding unit 302 at both ends of the intermediate driveline assembly 300. The wires 103 and 104 as well as the folding unit 302 are encompassed by a sheath or wrapping 301. Here, it is an helicoidal wrapping with a separation line 306 of the wrapping. The wires 103 and 104 are shown in Fig. 2 after unfolding.

[0071] At the same time, Fig. 2 also shows a modification of the first embodiment where the The unfolding unit 302 comprises at each of its ends an essentially triangular silicone flap 303 with the smallest 304 portion directed to the distal driveline portion 102 and the proximal driveline portion 101 , respectively, at which smallest portion the isolated electricity wires and load carrying wire(s) enter the triangular silicone flap 303, wherein the isolated electricity wires 103 and load carrying wire(s) 104 are guided in the triangular silicone flap 303 towards the larger portion 305 where the electricity wires 103 and the load carrying wire(s) 104 are positioned in said required spacing 12 from each other over this predetermined distance 11 in that plane.

[0072] Fig. 3 shows the schematical perspective view of Fig. 2 in connection with the implanting situation with a patient. Fig. 4 shows a partial detailed view relating to suturing the wound of the opening 20 as shown in Fig. 3. The skin 15 is essentially flat in a plane as shown by plane 13. The distal driveline portion 102 is connected to the implanted device under the skin of the patent and is guided through an opening 20 in the skin and continues outside the body of the patient in the proximal driveline portion 101 connected to a battery or power source. The electric wire portion with the reference numeral 103 is outside the body of the patient and the electric wire portion with the reference numeral 103' is under the skin.

[0073] Therefore, the surgeon is tunnelling the distal driveline portion 102 and at least a portion of the intermediate driveline assembly 300 through the skin 15 of a patient; then unwraps the sheath 301 ; and sutures each of the isolated electricity wires 103 and load carrying wire(s) 104 next to each other in a spacing 12 on the skin 15 (not directly shown in Fig. 4) with an interstice. The suturing step comprises here eight deep sutures 111 parallel to and between and outside of the seven wires 103 and 104 and one running superficial suture 112 covering the wires 103 and 104. 2022-153

[0074] 10

[0075] This embodiment shows six electrical wires 103 and a central load carrying wire 104.

[0076] Fig. 5 shows a schematical and partial transparent perspective view of the proximal portion 400A of a connection assembly 200 according to a second embodiment of the invention. More details can be seen in Fig. 6 showing a schematical and partial transparent perspective detail view of Fig. 5 with the pivotable front part 411 of the activation rod 420 raised; as well as in Fig. 7 showing the view of Fig. 6 when the needles 403 are pushed out of the pivotable front part 411.

[0077] The proximal connection block 411 comprises an activation rod 420 and a pivotable front part, comprising a prism shaped gliding surface with an upper transverse embossment 407.

[0078] The activation rod 420 comprises a pulling unit 421 which is shown in Fig. 6 and Fig. 7 in the pulled position raising the pivotable front part 411 of the activation rod 420. Inside the pivotable front part 411 is provided a slidable guide 405 which is adapted to be displaced by the action of the pushing rod 422 opposite to the activation rod 420 of proximal connection block 401. It can be seen in Fig. 7 that portions of the pushing rod 422 are displacing the slidable guide 405. At the same time, the needles 403 are all pushed out through a front opening in the pivoted front part 411 .

[0079] Fig. 8 shows a schematical and partial transparent perspective detail view of the slidable glide 405 with pushed-out needles 403 as in Fig. 7. Behind the needles 403 are through holes 402 for all wires 103 and 104. Additionally, the through holes 402 are large enough to ensure that a predetermined length of wires 103, 104 is stored in these through holes 402 until the end of the pushing out step of the needles 403.

[0080] Fig. 9 shows a schematical and partial transparent cross-section detail view of the slidable glide 405 with pushed-out needles 403 as in Fig. 8, wherein the slidable glide 405 is displaced towards and below the skin 15, since the raised pivotable part 411 is raised. The pivoted part 411 is gliding on the upper transverse embossment 407.

[0081] Fig. 10 shows a schematical and partial transparent cross-section view of the positioned tunneler 410 after raising the glide 405 and before pushing the needles 403 out. The activation of the activation rod 420 is done by two switches at the area 21 of the tunneler 410. The reference numeral 21 is related to opening in the skin 15 for implanting the medical device. 2022-153

[0082] 11

[0083] The isolated electricity wires 103 and here two load carrying wire(s) 104 as outside positioned wires are positioned side by side in longitudinal through holes 402 in the proximal connection block 401 , wherein each wire 103 and 104 is connected to an associated piercing needle 403 on the opposite side of the proximal driveline portion 101. As said before, each wire 103, 104 has a predetermined additional length 404 stored in the proximal connection block 401.

[0084] The tunneler 410 is integrated with the proximal driveline portion 101 and comprises an activation rod 420 connected to the proximal connection block 401. The activation rod 420 comprises a pulling unit 421 and a pushing unit 422, wherein, upon a pulling of the pulling unit 421 , the proximal connection block 401 is adapted to raise up against the plane of the tunneler 410, wherein, upon pushing the pushing unit 422, the activation rod 420 and proximal connection block 401 are adapted to push the needles 403 out of the proximal connection block (as shown in Fig. 8). The activation elements for the pulling and pushing actions are switches integrated within the pulling and pushing rods 421 and 422, respectively. The tunneler 410 can be positioned between tissue 16 of the patient and skin 15 of the patient. The bulge 17 of the raised skin portion is clearly seen, positioning the direction of the needles 403 essentially perpendicularly to the covering skin portion.

[0085] Fig. 11 shows a schematical perspective view of the distal connection block 430 of the intermediate drive assembly portion 400B according to the second embodiment. The distal connection block 430 comprises a proximal side part 431 having the same number of through holes 433 as the number of isolated electricity wires 103 and load carrying wire(s) 104 as well as a distal side silicone part 432 adapted for catching the needles 403 when exiting the proximal side part 431 entering it 432. It is possible that the proximal side part 431 has different cavities and especially a lower number of holes for receiving the needles 403. In other words, the number of holes isnot necessarily equal to the number of wires. This can be the case (not shown in the drawings) if one of the load carrying wires do not enter the holes. Instead, they could be anchored i) on the skin, ii) on a side spot of the electrical connection, iii) or a sacrificial protective cap. Another example could be when two wires are ejected by the tunneler (not shown in the drawings). In this case, the final wound size could still be small (~1 mm) compared to larger drivelines of 4-6 mm in diameter. In this case, the ejected electric and load bearing wires could a) enter the holes together, b) manually separated by the surgeon so only the electricity wires stay in the holes, or c) surgeons guide the single electric wires manually in the holes. It is also possible that two 2022-153

[0086] 12 electricity wires 103 are attached together to a needle and are thus guided without any space between them.

[0087] The previous drawings of the connector assembly 200 for connecting external power sources to an implanted medical device through the skin of a patient shows the tunneler 410 which is to be positioned through the surgical opening 21 in the skin 15 for implanting the medical device below the skin. Then, the proximal connection block 401 is positioned near the predetermined exit site of the driveline elements and the proximal connection block 401 is raised against the skin 15 by pulling the pulling unit 421 of the activation rod 420. Then, by pushing the pushing unit 422 of the activation rod 420, the needles 403 traverse one beside another in a spacing 12 through the skin of the patient. The distal connection block 430 is positioned near the traversing area so that the needles 403 can be caught by the distal side silicone part 432 after having passed the proximal side part 431 of the distal connection block 430. The distal connection block 430 is positioned near (or far) or appropriately so the length of the needles protruding outside the skin suffices to get through the proximal side part 431 and enter the distal side silicone part 432. As soon as the needles enter the distal side silicone part 432, the distal side silicone part 432 with the needles 403 could be pulled out.

[0088] With reference to Fig. 16, with the needles 403 pushed out and having traversed the distal connection block 430 and entering with the distal side silicone part pulling the additional length out by moving the distal side silicone part away from the skin and needle crossing area. When pulling the distal side silicone part 432 for a length up to the predetermined additional length 404 stored in the proximal connection block, the proximal side part 431 of the distal connection block 430 is positioned in a predetermined distance from the distal connection block 430.

[0089] Fig. 12 shows a schematical and partial transparent cross-section detail view from above on the proximal side part 431 of the distal connection block 430 of Fig. 11 . The ends of the needles 403 are shown before entering the holes 433. The opening of the holes 433 are tapered to allow an easier introduction in these holes.

[0090] The proximal side part 431 has a fixating unit 436 for attaching the load carrying wire(s) 104 to the proximal side part 431. These are switches on both sides of the part 431 and the action of the fixating unit 436 can be seen in Fig. 14. Fig. 14 shows a schematical crosssection detail view from the side on the proximal side part from Fig. 11 and Fig. 12 at a 2022-153

[0091] 13 plane cutting through one of the load bearing wires 104.

[0092] A similar procedure is then executed using the connecting unit 435 for attaching the isolated electricity wires 103 to the proximal side part 431 and for connecting each of the electricity wires 103 electrically to his associated exit contact inside the proximal side part 431. Fig. 13 shows a schematical cross-section detail view from the side on the proximal side part from Fig. 11 and Fig. 12 at a plane cutting through one of the electricity wires 103.

[0093] Both units 435 and 436 comprise a cutting blade 437 to cut through the wire 103 or 104. The fixating unit 436 has a long pressing portion on the load carrying wire 104 in the hole

[0094] 433. The connecting unit 435 has an isolation piercing connecting contact 438 for connecting the electrical wire 103 with a connecting element opposite the tapered entry

[0095] 434.

[0096] Fig. 15 shows a schematical perspective view of the distal connector 440 of the intermediate drive assembly 400B according to the second embodiment connected to the distal driveline 102. It comprises electrical contacts 441 adapted to enter the holes 433 of the proximal side part 431 to electrically contact the electrical wires 103 as well as latching lugs 442 for amovibly attaching the distal connector 440 to the proximal side part 431. On that end, as soon as the electrical contacts 441 enter the holes 433, the electrical connection shall be functional. Latching lugs 442 add extra security to pull out forces. The distal connector can have additional unlocking means for cleaning or maintenance of the distal device. These can be e.g. two complementary circular pins that connect and then lock and unlock the driveline to the distal device by being properly aligned.

[0097] In other words, the proximal side part 431 has a connecting unit 435 adapted for immobilizing the electricity wires 103 in the proximal side part 431 and is further adapted for connecting the electricity wires 103 one by one with an exit contact upon closing it, wherein the proximal side part 431 has a fixating unit 436 adapted for immobilizing the load carrying wire(s) 104 upon closing it. The distal connector 440 is applied to the proximal side part 431 after having removed the distal side silicone part 432. It is noted that the tunneler 410 is also removed from the patient. After penetration of the needles 403 through the skin and external anchorage by the surgeons either by 431 and 432 or 431 or otherwise, the tunneler can simply slide backwards letting 400A free for connection. Note that 400A could have a different end such as a circular driveline / cable. 2022-153

[0098] 14

[0099] LIST OF REFERENCE SIGNS

[0100] 10 longitudinal direction

[0101] 11 predetermined distance (flat plane)

[0102] 1 T portion of predetermined distance (parallel cables)

[0103] 12 spacing

[0104] 13 plane parallel to skin

[0105] 15 skin

[0106] 16 tissue

[0107] 17 lifted skin portion

[0108] 20 opening in skin

[0109] 21 opening in skin for implanting the medical device

[0110] 100 connector assembly

[0111] 101 proximal driveline portion

[0112] 102 distal driveline portion

[0113] 103 isolated electricity wire as cable

[0114] 103' wire below the skin

[0115] 104 load carrying wire as cable

[0116] 111 suture

[0117] 112 suture

[0118] 200 connector assembly

[0119] 300 intermediate drive assembly

[0120] 301 sheath

[0121] 302 unfolding unit

[0122] 303 silicone flap

[0123] 304 smallest portion

[0124] 305 larger portion

[0125] 306 separation of wrapping

[0126] 400A / B intermediate drive assembly

[0127] 401 proximal connection block

[0128] 402 longitudinal through hole

[0129] 403 piercing needle

[0130] 404 additional length

[0131] 405 slidable glide

[0132] 406 prism-shaped gliding surface

[0133] 407 embossment 2022-153

[0134] 15

[0135] 410 tunneler

[0136] 411 pivotable front part

[0137] 420 activation rod

[0138] 421 pulling unit 422 pushing unit

[0139] 430 distal connection block

[0140] 431 proximal side part

[0141] 432 distal side silicone part

[0142] 433 through hole 434 tapered entry

[0143] 435 connecting unit

[0144] 436 fixating unit

[0145] 437 cutting blade

[0146] 438 connecting contact 440 distal connector

[0147] 441 electrical contact

[0148] 442 latching lug

Claims

2022-15316CLAIMS1. A connector assembly (100, 200) for connecting an external electrical device to an implanted device with a distal driveline portion (102) and a proximal driveline portion (101), characterized in that the distal driveline portion (102) and the proximal driveline portion (101) comprise a plurality of cables (103, 104), in that the connector assembly (100, 200) further comprises an intermediate driveline assembly (300, 400A, 400B) adapted to arrange the cables (103, 104) for a predetermined distance (11) in the longitudinal direction (10) of these cables (103, 104), wherein the cables (103, 104) are positioned in a spacing (12) from each other over at least a part of this predetermined distance (1 T).

2. The connector assembly according to claim 1 , wherein each of the cables (103. 104) comprises at least one isolated electricity wire (103) or at least one isolated electricity wire (103) with a load bearing reinforcement or a load carrying wire (104).

3. The connector assembly according to claim 1 or 2, wherein the cables (103, 104) are arranged in the longitudinal direction (10) in a flat plane (13).

4. The connector assembly according to claim 1 or 2, wherein the cables (103, 104) are arranged in the longitudinal direction (10) in a circular or elliptical plane with one or two optional central cables or in two or more parallel flat planes.

5. The connector assembly according to any one of claims 1 to 3, wherein the intermediate driveline assembly (300) comprises the cables as continuously running cables (103, 104).

6. The connector assembly according to claim 5, wherein the cables are folded cables (103, 104).

7. The connector assembly according to claim 5 or 6, wherein the intermediate driveline assembly comprising a cable separating unit (302) at both of its ends adapted to separate the cables (103, 104).

8. The connector assembly according to any one of claims 5 to 7, wherein the intermediate driveline assembly comprises a sheath (301) surrounding the cables (103.2022-15317104) and - where present - the cable separating unit (302).

9. The connector assembly according to claim 8, wherein the sheath (301) is a helicoidal wrapping.

10. The connector assembly according to any one of claims 7 to 9, wherein the separating unit (302) comprises at each of its ends a flexible flap (303) with a smaller end portion (304) and a larger end portion (305), wherein the smaller end portion (304) is directed to the distal driveline portion (102) and the proximal driveline portion (101), respectively, at which smaller end portion (304) the cables (103, 104) enter the flexible flap (303), wherein the cables (103, 104) are guided in the flexible flap (303) towards the larger end portion (305) where the cables (103, 104) are positioned in said required spacing (12) from each other over the part of this predetermined distance (1 T) in that plane.

11. The connector assembly according to claim 10, wherein the tapered section between the smaller end portion (304) and the larger end portion (305) of the flexible flap (303) has a triangular, trapezoid, polygon or curved shape.

12. The connector assembly (200) according to any one of claims 1 to 4, wherein the intermediate driveline assembly (400A, 400B) comprises a proximal connection block (401) with piercing needles (403) positioned side by side in their longitudinal direction on the opposite side of the proximal driveline portion (101), wherein each piercing needle (403) is connected to one or more cables (103, 104) and wherein each cable (103, 104) has a predetermined additional length (404) stored in the proximal connection block (401), and wherein the intermediate driveline assembly (400A, 400B) further comprises a tunneler (410) integrated with the proximal driveline portion (101), wherein the tunneler (410) comprises an activation rod (420) connected to the proximal connection block (401) and comprising a pushing unit (422), wherein the activation rod (420) and proximal connection block (401) are adapted to push the needles (403) out of the proximal connection block upon pushing the pushing unit (422); wherein the intermediate driveline assembly (400A, 400B) further comprises a distal connection block (430) comprising a proximal side part (431) having a number of through holes (433), especially equal to the number of cables, as well as a distal side flexible part (432) adapted for catching the needles (403) when exiting the proximal side part (431) entering it (432), wherein, when the cables have electricity wires (103), the proximal side part (431) has one or more connecting units (435) adapted for immobilising the electricity wires (103) and further adapted for connecting the electricity2022-15318 wires (103) one by one with an exit contact upon closing it (435), and wherein the intermediate driveline assembly (400A / 400B) comprises a distal connector (440) adapted to amovibly connect with the proximal side part (431) of the distal connection block (430), when the distal side flexible part (432) is removed from the proximal side part (431).

13. The connector assembly according to claim 12, wherein the proximal connection block (401) comprises a slidable glide (405) in which the needles (403) are positioned extending beyond the front surface of the slidable glide (405).

14. The connector assembly according to claim 12 or 13, wherein the activation rod(420) comprises a pulling unit (421) and wherein the proximal connection block (401) is adapted to raise up against the plane of the tunneler (410) upon a pulling of the pulling unit(421).

15. The connector assembly according to any one of claims 12to 14, wherein, when the cables comprise load carrying wires (104), the proximal side part (431) has one or more fixating units (436) adapted for immobilising the load carrying wire(s) (104) upon closing it (436).

16. A method of positioning a connector assembly according to any one of claims 1 to3 or 5 to 11 for connecting external devices to an implanted device through the skin of a patient, comprising tunnelling the proximal driveline portion and at least a portion of the intermediate driveline assembly through the skin of a patient; unwrapping the sheath; suturing each of the cables next to each other on the skin with an interstice.

17. The method according to claim 16, wherein the sheath is removed from the surgical area or pushed under the skin of the patient.

18. A method of positioning a connector assembly according to any one of claims 1 to4 or 12 to 15 for connecting external devices to an implanted device through the skin of a patient comprising positioning the tunneler through the surgical opening in the skin for implanting the medical device below the skin, positioning the connection block near the predetermined exit site of the driveline elements, raising the connection block against the skin by pulling the pulling unit of the activation rod; pushing the needles through the skin of the patient by pushing the pushing unit of the activation rod; catching the needles by the distal side flexible part after having passed the proximal side part of the distal connection2022-15319 block; pulling the distal side flexible part for a length up to the predetermined additional length stored in the proximal connection block and positioning the proximal side part of the distal connection block in a predetermined distance from the distal connection block; activating, if present, the fixating unit for attaching the load carrying wire(s) of the cables to the proximal side part; activating the connecting unit for attaching the isolated electricity wires of the cables to the proximal side part and for connecting each of the electricity wires electrically to his associated exit contact inside the proximal side part; removing the distal side flexible part; and removing the tunneler from the patient.

Images