Clamping device for connection to an implantable lead

Abstract

The invention is directed to a clamping device (20) configured for connection to a proximal portion of an implantable lead having a number of N ring contacts (N ≥ 1) and a terminal pin. The clamping device provides a low-cost and reliable mechanical and electrical connection between the terminal end of different types of implantable leads and different pacing system analyzer types with different alligator pins and comprises - a main body comprising an outer surface and an inner lumen extending through the main body into a longitudinal direction, - a number of M electrically conductive wires, where M ≥ N, extending along the outer surface, through the main body and within the inner lumen of the main body and extending transversely to the longitudinal direction.

Description

[0001] Applicant: BIOTRONIK SE & Co. KG

[0002] Date: 14.05.2025

[0003] Our Reference: 23.143P-WO

[0004] Clamping Device for Connection to an Implantable Lead

[0005] The invention refers to a clamping device configured for connection to a proximal portion of an implantable lead having at least one ring contact and a terminal pin.

[0006] Various types of medical electrical leads for use in cardiac rhythm management (CRM) and neurostimulation applications are known. In CRM applications, for example, such leads are frequently delivered intravascularly to an implantation location on or within a patient’s heart, typically under the aid of fluoroscopy. Once implanted, the lead is coupled to a pulse generator or other implantable device for sensing cardiac electrical activity, delivering therapeutic stimuli, and / or for performing some other desired function within the body. Such leads often include one or more ring electrodes for sensing and delivering electrical stimuli at their distal end and a proximal, terminal end which is connected to the pulse generator or a measuring device. The terminal end of the lead usually includes one or more electrical ring contacts and a terminal pin that are electrically connected to the electrodes at the distal end of the lead via a number of conductors. In certain applications, the leads are tested for proper positioning and function as part of the implantation process and prior to being connected to the pulse generator or other implantable device, allowing the implanting health care practitioner (HCP) to evaluate pacing, stimulating and / or sensing performance prior to concluding that the particular lead position is suitable. During the testing process, for example, a Pacing System Analyzer (PSA) or another analyzer may be connected to the terminal end of the lead to test the connection of the distal end of the lead to the heart or other target position within the patient’s body and / or to evaluate the performance of the lead. To facilitate connection of the PSA or another analyzer to the lead, a number of alligator clips can be temporarily coupled to the terminal end of the lead, allowing the conductors of the PSA to be connected to the electrical contacts and the terminal pin at the terminal end of the lead.

[0007] When using different types of leads and / or different types PSA with different alligator clips there is the desire to provide reliable mechanical and electrical connection between the contact rings of the terminal end of the lead and the alligator clips.

[0008] Accordingly, it is an object of the present invention to provide a simple, low-cost and reliable mechanical and electrical connection between a terminal end of different types of implantable leads with at least one ring contact and different PSA or other analyzer types having different alligator clip types.

[0009] The above object is solved by the clamping device of claim 1.

[0010] In particular, the above object is solved by a clamping device configured for connection to a proximal portion of an implantable lead having a number of N ring contacts (N > 1) and a terminal pin, the clamping device comprising

[0011] - a main body comprising an outer surface and an inner lumen extending through the main body into a longitudinal direction, wherein the inner lumen is configured to accommodate the proximal portion of the implantable lead, wherein the main body is manufactured from electrically insulating material,

[0012] - a number of M electrically conductive wires, where M > N, extending along the outer surface, through the main body and within the inner lumen of the main body and extending transversely to the longitudinal direction, wherein the main body and / or the M wires is / are configured to adopt a clamping state in which a clamping connection to the proximal portion of the implantable lead is provided and in which each one of a pre-defined number of wires of the M wires provides an electrically conducting connection to one ring contact of the N ring contacts depending on the type of lead.

[0013] The clamping device as defined above and described in more detail below forms an intermediate device to be connected with the proximal end of the lead and with alligator clips of different type for different PSA. The clamping device may be a single-piece or consist of two or more than two elements which may be coupled. In the clamping state of the main body, the clamping device can adapt to the type of lead (e.g. its outer diameter and its number N of ring contacts). Further, the outer surface of the clamping device may be configured such that different types of alligator pins may be used. Additionally, when using the clamping device the alligator pins do not directly contact the contact rings of the lead so that they cannot scratch the ring contacts.

[0014] The main body of the clamping device comprises an outer surface and an inner lumen. The inner lumen has, for example, a cylindrical shape for accommodating the proximal portion of the implantable lead. The main body is manufactured from electrically insulating material, for example, a plastic material such as POM, PET, or similar materials. The main body protects the proximal portion of the implantable lead and functions as a support for the alligator pin(s) when they are clamped to the electrically conductive wires for electrical connection of the lead to the PSA. The inner diameter of the inner lumen may be at least 3.2 mm. The clamping device further comprises a number of M electrically conductive wires, where M > N. Each wire extends along the outer surface, through the main body and within the inner lumen of the main body. Each wire extends transversely to the longitudinal direction. Further, the main body and / or the M wires is / are configured to adopt a clamping state in which the wire provides a clamping connection to the proximal portion of the implantable lead and an electrically conducting connection to one ring contact of the N ring contacts depending on the type of lead. In the clamping state, each conductive wire and / or the main body mechanically clamps the proximal section of the implantable lead, for example, by reduction of the inner diameter of the inner lumen at the position of proximal section of the implantable lead. The clamping connection may comprise a fixed or a sliding connection between the proximal section of the implantable lead and the wires and / or the main body. Additionally, each wire position is configured such that it corresponds to the position of one ring contact, so that the mechanical connection to the proximal portion of the implantable lead at the same time functions as an electrical connection to the respective ring contact. Each wire may comprise electrically conductive material such as metal material, for example MP35N. The diameter of such a wire may be, for example at least 0.1 mm, e.g. at least 0.3 mm. In the case where M > N, there is at least one wire not connected to one ring contact. In the case where M = N each wire is connected to one (different) ring contact of the proximal section of the implantable lead. The wire may comprise any cross section, for example a circular cross section, or the wire may be a flat wire.

[0015] As one can derive from the following more detailed explanation, the clamping device provides a simple, low-cost and reliable mechanical and electrical connection between a terminal end of different types of implantable leads with at least one ring contact and different PSA or other analyzer types having different alligator clip types. Exemplary implantable leads (also referred to as lead connectors) that can be used in conjunction with the clamping device may include, but are not limited to, cardiac re synchronization therapy (CRT) or pacing leads (e.g., including a quadripolar (e.g., IS-4 or similar) connector, or a dual-pole (e.g., IS-1 or similar) connector), implantable cardioverter defibrillator (ICD) leads (e.g., including a quadripolar (DF-4 or similar) connector, or a lead with multiple IS-I and / or DF- I type connectors), and leads including additional sensing capabilities (e.g., a pressure sensing / pacing lead with a quadripolar type connector). Other types of leads and / or lead connector types can also be used in conjunction with clamping device, as desired.

[0016] In one embodiment, each main body and / or wire is configured to adopt an open state in which the proximal portion of the implantable lead is free to slide within the inner lumen of the main body. The open state is used in order to introduce the proximal portion of the implantable lead into the inner lumen of the main body. In the open state, the inner diameter of the inner lumen is, for example, greater than the outer diameter of the proximal portion of the implantable lead and the inner diameter of the inner lumen is not reduced by the M electrically conducting wires and / or by the mains body such far that no clamping effect occurs. The state of the M electrically conducting wires and / or the main body can be changed between the open state and the clamping state in one embodiment at least once and in another embodiment several times.

[0017] In one embodiment, the main body comprises a first section and a second section accommodated adjacently to the first section in longitudinal direction and coupled to the first section, wherein the first section comprises the M wires, wherein the second section is sized to frictionally engage a sealing section of the implantable lead, wherein the second section is rotatable with respect to the first section about the longitudinal axis. This includes that either the whole first or second section is rotatable relative to the other one of the first or the second section and that a part of the first section is rotatable relative the second section. Usually, the sealing section of the implantable lead is accommodated directly distally from the proximal section comprising the ring contacts. In the sealing section, the outer diameter of the implantable lead is greater than in the proximal section. Distal from the sealing section, the implantable lead comprises a cable section having an insulating layer at its outer surface forming the electrically insulated connection to the distal end of the implantable lead. The implantable lead may be accommodated within the first section and the second section of the main body. Both, the first section and the second section comprise an inner lumen, wherein the inner lumen of the second section is continued by the inner lumen of the first section. When the proximal section of the implantable lead is introduced into the main body, it is first introduced into the inner lumen of the second section and then into the inner lumen of the first section. Since the second section is sized to frictionally engage a sealing section of the implantable lead that it is directly distally from the proximal section of the implantable lead, the implantable lead is fixed within the inner lumen of the second section if the implantable lead is introduced such far into the inner lumen that the sealing section is engaged with the inner lumen of the second section. However, in this state, since the second section is rotatable relative to the first section about the longitudinal axis, the first section or a part of the first section can be rotated relative to the proximal section of the implantable lead. This embodiment is advantageous for implantable leads which are implanted using a catheter or which are fixed using a screw fixation. By using the second section of the main body which is connected torque-proof to the sealing section of the implantable lead, a torque can be provided to the implantable lead by the HCP using the second section in order to fix the electrode at the target position within the patient’s body. In one embodiment, an intermediate element may be used and located between the first section and the second section. The intermediate element may be coupled to the first section and the second section.

[0018] With regard to above explained embodiments, the rotation of the second section of the main body relative to the first section of the main body (or part of the first section) may be realized by, for example, respective coupling elements, wherein one of the coupling elements may be flexible for providing the rotatable coupling of the first and the second section. For example, the coupling elements may comprise a ring-like protrusion at one of the first section and the second section and a respective circumferential recess at the other one of the first section and the second section. The ring-like protrusion is dimensioned such that the inner diameter of the recess corresponds to the outer diameter of the protrusion so that the protrusion can be rotated within the recess and a displacement of the first section and the second section relative to each other in longitudinal direction is prevented. In one embodiment, the leading edge of the protrusion may be sloped in order to ease establishing the coupling of the protrusion and the recess. Further, the portion of the first or second section comprising the protrusion may be flexible, for example due to a longitudinal slit at this portion. In one embodiment, the at least one wire of the first section of the main body may form a sliding contact so that the electrical connection of the ring contact via the wire and the alligator clip is kept when the second section rotates relative to the first section.

[0019] In one embodiment, the second section may comprise at least one slit, for example at least two slits, in the wall of the second section extending in longitudinal direction. Such slit / slits provide a predefined flexibility of the second section so that HCP grasping the second section for application of a torque to the implantable lead may fix the second section torque-proof to the implantable lead.

[0020] In one embodiment, the clamping state may be configured such that the first section of the main body is fixed torque-proof to the proximal portion of the implantable lead. In this embodiment, when atorque may be applied to the implantable lead as explained above, a protruding flap having a contact pad for each wire (i.e. M contact pads) may be provided, wherein the protruding flap forms a support section for the alligator clip. This protruding flap may be fixedly or rotatably coupled to the first section of the main body. The protruding flap may comprise M sliding contacts (one for each wire) extending to the outer surface of the first section of the main body for rotatable coupling. The rotatable coupling may be realized similar to the rotatable coupling of the first and second section of the main body using a circumferential recess and a corresponding ring-like protrusion.

[0021] In one embodiment, each wire is connected to a contact pad accommodated at a protruding flap of the main body. The protruding flap may be fixed to the outer surface of the main body (or its first section) or, as explained above, may be rotatably coupled to the outer surface of the main body (or its first section).

[0022] In one embodiment, the wire is configured such that it extends fully around the inner lumen, i.e. around its inner circumference. This embodiment provides a very secure electrical connection between the ring contact and the electrically conducting wire. In an alternate embodiment, the wire is configured such that it extends around a part of the circumference of the inner lumen, for example, covering an angle of at least 180° of the circumference. In one embodiment, the main body (or its first section) or the protruding flap of the main body is configured to accommodate an alligator clip. Accordingly, for example, the thickness of the main body (or its first section) or the protruding flap is adapted to the dimensions of different types of alligator clips.

[0023] In one embodiment, the main body comprises an inner sleeve and an outer sleeve where one of the inner and the outer sleeves are concentrically rotatable with respect to the other sleeve of the inner and the outer sleeve, wherein the open state is realized in a first rotation state and the clamping state is realized in a second rotation state different from the first rotation state. The inner lumen of the main body is formed by the inner sleeve. In this embodiment, the main body comprises two sleeves, wherein the inner sleeve rotatably extends within the outer sleeve. The rotation of the outer sleeve relative to the inner sleeve stretches the M wires extending transversely to the longitudinal direction which is identical or parallel to the rotation axis. Accordingly, by the rotation the stretching of the M wires reduces the inner diameter of the inner lumen of the main body provided by the inner sleeve. For that, each wire is at one end portion fixed to the outer sleeve and at its opposite end portion fixed to the inner sleeve. Accordingly, the relative rotation of the inner sleeve and the outer sleeve either further separates the attachment (fixing) positions of the respective wire on the inner sleeve and the outer sleeve thereby reducing the inner diameter of the inner lumen or, when rotation is provided in the opposite direction, brings the attachment positions at the inner sleeve and the outer sleeve of each wire closer together.

[0024] This may be realized in a simple embodiment, in which the inner sleeve comprises at least one slit-like opening configured to accommodate one wire of the M wires. The respective wire extends from the outer surface of the main body through an opening in the outer sleeve, through the slit-like opening within the inner sleeve to the inner lumen. The slit-like opening gives the wire enough space to move. In the open state, the wire is not stretched and forms a curve since the attachment positions of the respective wire on the inner sleeve and the outer sleeve are located close together. In the clamping state, the respective wire is stretched and is driven to form the shortest connection between the attachment positions at the inner sleeve and the outer sleeve by the relative rotation of the inner and the outer sleeve. Accordingly, it does not form any curve but a straight line. When the respective wire is stretched, the attachment positions at the inner sleeve and the outer sleeve are configured such that the wire reduces the inner diameter of the inner lumen and thereby forms a mechanically clamping connection and an electrically conducting connection to the respective ring contact. Accordingly, at least two slit-like openings are configured such that their distance corresponds to the distance of two adjacent ring contacts of the proximal portion of the implantable lead. A slit-like opening may comprise a thickness (length in longitudinal direction) of at least 0.2 mm, for example of at least 1 mm, wherein the thickness of the slit-like opening is adapted to the thickness of the respective wire. The slit of the slit-like opening may span an angle of at least 10°, for example at least 40° of a full circle, wherein the circle is considered transverse, for example, perpendicular to the longitudinal direction. Using the same principle, electrically insulating threats can also be stretched between the electrically conducting wires to prevent a short circuit caused by body fluids. In another embodiment, the M wires are not fully flexible but partly and comprise a buckle extending into the direction of the longitudinal axis thereby increasing the reliability of the electrical connection between the wire and the ring contact.

[0025] In one embodiment, the main body comprises two jaw-like sections extending like cantilevers from a, for example, bar-like central section, wherein the inner lumen is formed between the jaw-like sections. This is a very simple embodiment, wherein the two jaw-like sections adopt an initial state in which there is no restoring force between the two opposite jaw-like sections (force-free state). This state is a state prior introducing the proximal section of the implantable lead into the inner lumen. The jaw-like sections may be separated from each other against a restoring force thereby providing the open state. Hence, in one embodiment, the two jaw-like sections are configured such that by pushing them apart against the restoring force they thereby transition the main body to the open state. For introducing the proximal portion of the implantable lead into the inner lumen between the jaw-like sections, they must be slightly separated from each other against the restoring force so that the proximal portion of the implantable lead can be clamped between the opposite jaw-like sections. To securely clamp the proximal section of the implantable lead by the main body, each jaw-like section comprises a protrusion, formed, for example by a silicone cylinder. Each protrusion is accommodated at the end of the jaw-like section opposite the central section and forms a counter bearing or stop surface for the proximal portion of the implantable lead that prevents the proximal portion from slipping out of the inner lumen. In an alternative embodiment, the jaw-like sections may be pressed against each other against a restoring force thereby providing the open state. The open state is realized by pressing the jaw-like sections against each other because they are connected by the at least one wire. By pressing the jaw-like sections, each wire is slightly bent such that the diameter of the inner lumen formed between the jaw-like sections and the wires is increased such that the proximal section of the implantable device can be introduced between the opposite jaw-like sections. If the HCP lets the jawlike sections go, they return to their initial state so that the at least one wire and / or the main body clamps the proximal section of the implantable lead and provides the respective electrical connection of the ring contacts and the wires.

[0026] In one embodiment, the main body is configured such that a compressive force applied to the outer surface of the main body in the direction of the inner lumen and transversely or radially with respect to the longitudinal direction against a restoring force transitions the main body to the open state. This embodiment may comprise an inner diameter of the inner lumen of the main body which is smaller in one radial direction than in a perpendicular radial direction. For example, the inner lumen of the main body may be 0.1 mm smaller than the outer diameter of the proximal section of the implantable lead and in the perpendicular regular direction 0.1 mm greater than the outer diameter of the proximal section of the implantable lead. Accordingly, if the main body can be elastically deformed by a compressive force applied to the outer surface of the main body in the first radial direction having the greater inner diameter, this inner diameter is reduced and, at the same time, the inner diameter of the second radial direction perpendicular to the first radial direction is increased such that the main body transitions to the open state in which the proximal portion of the implantable lead can be introduced into the inner lumen of the main body. For easy deformation of the main body by the compressive force, the main body may comprise wing-like extensions protruding from the outer surface of the main body. These wing-like extensions are accommodated at a position that is to be compressed in order to transition the main body to the open state. These wing -like extensions can be easily grasped by an HCP and they form a visual indication to the HCP with regard to the compression direction for transition of the main body to the open state. Additionally, the wing -like extensions may be used to attach the alligator clips in an easy way. In one embodiment, each wire extends from the inner lumen through the main body and along the outer surface one of the wing -like extensions.

[0027] The present invention will now be described in further detail with reference to the accompanying schematic drawing, wherein

[0028] Fig. 1 shows a terminal end of an implantable lead in a perspective side view,

[0029] Fig. 2 a first embodiment of a clamping device in a partial cutaway perspective side view,

[0030] Fig. 3 a cross section of the first embodiment of Fig. 2 of a clamping device with an implantable lead in a first state,

[0031] Fig. 4 a cross section of the first embodiment of Fig. 2 of a clamping device with an implantable lead in a second state,

[0032] Fig. 5 the embodiment of a clamping device of Fig. 2 in a partial cutaway perspective side view with fixed alligator clips in perspective side view,

[0033] Fig. 6 a cross section of a second embodiment of a clamping device with an implantable lead in a first state,

[0034] Fig. 7 a cross section of a third embodiment of a clamping device with an implantable lead in a first state, Fig. 8 a fourth embodiment of a clamping device in a partial cutaway perspective side view with a fixed alligator clip in a perspective side view,

[0035] Fig. 9 a fifth embodiment of a clamping device in a partial cutaway perspective side view in a first state,

[0036] Fig. 10 the embodiment of Fig. 9 of a clamping device in a partial cutaway perspective side view in a second state,

[0037] Fig. 11 a first section of the embodiment of Fig. 9 of a clamping device in a partial cutaway perspective side view in the first state,

[0038] Fig. 12 the embodiment of Fig. 9 of a clamping device in a partial cutaway perspective side view in a second state with a proximal section of an implantable lead in a perspective side view,

[0039] Fig. 13 a sixth embodiment of a clamping device in a partial cutaway perspective side view in a second state,

[0040] Fig. 14 a cross section of a seventh embodiment of a clamping device with an implantable lead,

[0041] Fig. 15 the cross section of the embodiment of Fig. 14 of a clamping device with an implantable lead and a fixed alligator clip in a perspective side view,

[0042] Fig. 16 an eighth embodiment of a clamping device in a top view,

[0043] Fig. 17 a ninth embodiment of a clamping device in a partial cutaway perspective side view in a first state,

[0044] Fig. 18 a cross section of a tenth embodiment of a clamping device in a first state,

[0045] Fig. 19 a cross section of the embodiment of Fig. 18 of a clamping device in a second state with an implantable lead,

[0046] Fig. 20 a cross section of the embodiment of Fig. 18 of a clamping device in the third state with an implantable lead and a fixed alligator clip in a perspective side view, Fig. 21 an eleventh embodiment of a clamping device in a partial cutaway perspective side view in a first state,

[0047] Fig. 22 the embodiment of Fig. 21 of a clamping device in a partial cutaway perspective side view in a second state,

[0048] Fig. 23 a cross section of the embodiment of Fig. 21 of a clamping device in the second state,

[0049] Fig. 24 a cross section of a twelfth embodiment of a clamping device in a first state,

[0050] Fig. 25 a cross section of the embodiment of Fig. 24 of a clamping device in a second state with shaded implantable lead,

[0051] Fig. 26 a cross section of the embodiment of Fig. 24 of a clamping device in a third state with implantable lead, and

[0052] Fig. 27 a thirteenth embodiment of a clamping device in a top view.

[0053] In the following thirteen embodiments of a clamping device are explained in more detail with regard to an implantable lead having three ring contacts (N = 3) as shown in Fig. 1. The embodiments of the clamping device have three wires (M = 3), as well. Of course, other numbers of ring contacts and wires are possible and are included herewith. With regard to all embodiments of a clamping device, the wire may be realized as a wire with a circular cross section or as a flat wire. Such wire may have a thickness that is between 0. 1 mm and 0.4 mm. the wire material may be, for example MP35N.

[0054] The terminal end of the implantable lead shown in Fig. 1 comprises a proximal portion 10 having three ring contacts 11 and electrically insulating sections 12 therebetween. At the proximal end of the proximal portion 10 there is a terminal pin 13. Each one of the three ring contacts 11 and the terminal pin 13 are electrically connected to one electrode at the distal end of the implantable lead via a respective conductor. The outer diameter of the proximal portion 10 with the three ring contacts 11 may be, for example, 3.2 mm as defined for a DF4 terminal end. Directly distally from the proximal portion 10 a sealing section 14 is provided. Distally and adjacently from the sealing section 14 the implantable lead comprises a cable section 15, wherein the outer layer of the cable section 15 is an electrically insulating layer protecting and electrically insulating the conductors to the environment and with regard to each other. The sealing section 14 has the greatest diameter compared to the cable section 15 and the proximal portion 10. The sealing section 14 provides a sealing function when the implantable lead is connected to the pulse generator or a measuring device (both not shown). The first embodiment of a clamping device 20 is shown in fig. 2 to 4. The clamping device 20 comprises an outer sleeve 21 and an inner sleeve 23, wherein the outer sleeve 21 and the inner sleeve

[0055] 23 are rotatable about their longitudinal axis relative to each other. The inner sleeve 23 comprises an inner lumen 24 in which the proximal section 10 of the implantable lead is accommodated. The diameter of the inner lumen 24 is, for example, 3.6 mm. Further, the inner sleeve 23 comprises three slit-like openings 25. Each slit-like opening 25 extends through the whole wall of the inner sleeve 23 as one can derive from fig. 3. For example, the slit-like opening 25 covers an angle of, for example, 45° of a full circumference. The length of such slit-like opening 25 (a longitudinal direction) may be between 0.2 mm and 2 mm. At the outer surface of the inner sleeve 23 and the outer surface of the outer sleeve 21 an attachment position 27a, 27b is provided at which a wire 27 is attached. Accordingly, the wire 27 it extends from the attachment position 27a at one end of the slit-like opening 25, through the slit-like opening 25 to a corresponding through hole of the outer sleeve 21 to the attachment position 27b at the outer surface of the outer sleeve 21. As the slit-like opening 25 extends to the inner lumen

[0056] 24 of the inner sleeve 23, the wire 27 extends to the inner lumen 24, as well. The position of the wire 27 within the inner lumen 24 dependents on the rotating state of the inner sleeve 23 and the outer sleeve 21. In one or rotating state (i.e. the open state), the attachment positions 27a and 27b close together so that the wire 27 it is bent within the slit-like opening 25 as shown in fig. 3. In this state the proximal portion 10 of the implantable lead can easily be introduced into the inner lumen 24. When rotating, for example of the outer sleeve 21 relative to the inner sleeve 23 as shown by arrow 30 in fig. 3 the attachment positions 27a and 27b are moved apart from each other so that finally a second state is realized in which the wire 27 is stretched such that it touches the surface of a ring contact 11 (see fig. 4) thereby clamping the proximal portion 10 of the implantable lead and providing an electrical connection to the respective ring contact 11 (i.e. the clamping state). As one can derive from fig. 5, the three wires 27 ending at the outer surface of the outer sleeve 21 can be mechanically and an electrically coupled to three alligator clips 40 of a PSA, wherein each alligator clip 40 is connected to the PSA via a cable 42. The clamping device 20 allows a secure electrical connection of the ring contacts 11 to the PSA and provides a sliding contact, since the proximal portion 10 of the implantable lead is rotatable within the inner lumen 24 of the clamping device 20.

[0057] The second embodiment of a clamping device 120 is shown in fig. 6 is very similar to the first embodiment shown in fig. 2 to 4. In this embodiment, the wire 127 extends within the slit-like opening

[0058] 25 and at the outer surface of the inner sleeve 23 so that it covers a full circle. It is attached to the outer surface of the inner sleeve 23 at the attachment position 127a and at the outer surface of the outer sleeve 21 at the attachment position 127b. The third embodiment of a clamping device 220 as shown in fig. 7 is very similar to the first embodiment shown in fig. 2 to 4. In this embodiment, the wire is stiffer than in the first or the second embodiment and comprises a buckle 227c extending into the direction of the longitudinal axis. This buckle 227c comes first into contact with the ring contact 11 of the proximal portion 10 of the implantable lead when the outer sleeve 21 is rotated against the inner sleeve 23 to provide an electrical connection between the wire 227 and the ring contact 11. This increases reliability of the electrical connection between the wire 227 and the ring contact 11.

[0059] The fourth embodiment of the clamping device 320 as shown in fig. 8 is very similar to the first embodiment shown in fig. 2 to 4. In this embodiment, the outer sleeve 321 comprises at its outer surface a protruding flap 328 which comprises three contact pads 329 at its surface. The attachment position 27b of each wire 27 at the surface of the outer sleeve 321 is connected to the corresponding contact pad 329 at the surface of the protruding flap 328 via an electrically conducting connection as shown in fig. 8. As an example, an alligator clip 40 is attached to the central contact pad 329 at the surface of the protruding flap 328 forming an electrical connection to the PSA via the cable 42. The protruding flap 328 provides a well-defined mechanical and electrical connection with a contact pad 329 which has a larger surface than the wire 27 ends at the outer surface of the outer sleeve 21 of the first embodiment of a clamping device 20.

[0060] Fig. 9 to 12 show a fifth embodiment of a two-piece clamping device 420 comprising a first section and a second section. The first section of the clamping device 420 is very similar to the first embodiment of a clamping device as shown in fig. 2 to 4 comprising the three wires 27 for connection with the ring contacts 11. However, in this embodiment, the inner sleeve 423 extends from one end of the outer sleeve 21 by a protruding section 423a. This protruding section 423a comprises two opposite slits 423b extending in longitudinal direction. Additionally, the protruding section 423a comprises a ring-like protrusion 423c being a coupling element for coupling the first section to the second section. In particular, the ring-like protrusion 423c couples to a corresponding recess 422c of a hollow cylindrical second section 422. The hollow cylindrical second section 422 of the clamping device 420 comprises slits 422a extending in longitudinal direction and, within the same area of this second section 422, a riffle 422b is provided to ease grabbing of this second section 422 for the HCP. Fig. 9 shows the first state, in which the first section and the second section 422 are still decoupled. For coupling the first section is moved longitudinally into the direction of the second section 422 (see arrow 31). Due to the slits 423b the protruding section 423a of the inner sleeve 423 is slightly flexible and, as shown in fig. 13, the ringlike protrusion 423c is sloped at its the front edge relative to the direction of motion during coupling (see detail A in fig 11). Accordingly, the first section and the second section 422 can easily be coupled as shown in fig. 10. One can derive from fig. 10, that the coupling of the first section and the second section 422 of the clamping device 420 hinders relative longitudinal movement of these sections. However, in the coupled state the second section 422 can be rotated relative to the first section as indicated by arrow 32 in fig. 12. As shown in fig. 12, the inner diameter of the second section 422 is slightly smaller than the outer diameter of the sealing section 14 of the implantable lead. Accordingly, the implantable lead, when introduced into the in the lumen of the second section 422, it is fixed torque-proof relative to the second section 422. The HCP may rotate the second section 422 grabbing the riffles 422b thereby slightly pressing the sealing section 14 of the implantable lead. Accordingly, a torque may be applied to the implantable lead by rotating the second section 422 of the clamping device 420. When rotating the implantable lead in such way, the electrical connection of the ring contacts 11 to the wires 27 it is permanently assured because the wires 27 form sliding electrical contacts to the ring contacts 11.

[0061] Alternatively, the first section and the second section 422 may be fixedly coupled as shown in the sixth embodiment depicted in fig. 13. In this embodiment, a protruding flap 528 of the outer sleeve 521 is rotatable relative to the outer sleeve 521. Forthat, the protruding flap 528 comprises ring -like elements 528a which may slide within corresponding recesses 521a at the outer surface of the outer sleeve 521 (refer to fig. 13).

[0062] The seventh embodiment of a clamping device 620 is drawn in fig. 14 and 15. The main body of the clamping device 620 comprises a first jaw-like section 621 and a second, opposite jaw-like section 623 which are connected by a bar-like central section 621a at one of their ends. Three wires 6 1 are accommodated at the surface of the central section 621a encircling the surface as shown in fig. 14 each wire extends through the first jaw -like section 621 and a second jaw-like section 623 so that it protrudes into the inner lumen 624 between both jaw-like sections 621, 623. Another silicone element 626 may be located between the central section 621a and the wire 627 section extending within the inner lumen 624. At each one of the jaw-like sections 621, 623 a protrusion 625 is located at its inner surface, wherein each protrusion 625 may have a cylindrical shape and may be formed of silicone material. For accommodation of the proximal portion 10 of the implantable lead within the inner lumen 624, the jaw-like sections 621, 623 are pressed apart from each other against a restoring force to provide the open state. Then, the proximal portion 10 of the implantable lead can be introduced into the inner lumen 624 such that the protruding section of the wire 627 mechanically an electrically couples to a respective ring contact 11 of the proximal portion 10 of the implantable lead. By the restoring force, the proximal portion 10 of the implantable lead is clamped between the jaw-like sections 621, 623 when the pressing force is removed (clamping state). As shown in fig. 15, the alligator clip 40 can easily be fixed to the wire 627 section that is accommodated at the outer surface of the central section 621a and thereby electrically coupling the ring contact 11 to the PSA via wire 627. The eighth embodiment of a clamping device 720 depicted in fig. 16 is similar to the seventh embodiment but in this case the central section 721a comprises a protruding flap 728 having three contact pads 729 at its surface. Each contact pad 729 is connected to a respective wire 727 extending at the surface of the central section 721a. This embodiment allows a very convenient way to attach the alligator clip 40 to the clamping device 720 and provides a reliable electrical connection due to the size of the contact pad 729.

[0063] The ninth embodiment of a three-piece clamping device 820 shown in fig. 17 is derived from the eighth embodiment of fig. 16. The embodiment of fig. 17 comprises a protruding section 821a extending to one side of the jaw-like sections 621, 623. The protruding section 821a has the shape of a hollow cylinder for accommodation of the proximal portion 10 of the implantable lead. Further, the clamping device 820 comprises an intermediate element for coupling to the hollow cylindrical second section 422 which was already described with regard to the fifth embodiment of the clamping device 420 above. For coupling of the first section having the wires 727 to the second section 422, the intermediate element 823a is introduced into the inner lumen of the protruding section 82 la. The ring -like protrusion 823c is then coupled to the corresponding recess 422c of the second section 422 as described above. For ease of coupling step the intermediate element 823a comprises longitudinal slits 823c.

[0064] With regard to fig. 18 to 20 a 10th embodiment of a clamping device 920 is explained. In this embodiment, the clamping device 920 has the shape of a flattened hollow cylinder with an upper section 921 and a lower section 923 extending in longitudinal direction and forming wings 928 protruding from the portion where the upper section 921 and the lower section 923 connected. When pressing the wings 928 in a direction perpendicular to the longitudinal direction and against each other (see arrows 32 in Fig. 19), the inner lumen 924 between the upper section 921 and the lower section 923 is increased against a restoring force and with regard to a direction perpendicular to the pressing directions and perpendicular to the longitudinal direction. Fig. 19 shows the open state. In this state the proximal section 10 of the implantable lead may be introduced into the inner lumen 924 as shown in fig. 19. The initial state without pressing the wings 928 as shown in fig. 18. After introduction of the proximal section 10 of the implantable lead into the inner lumen 924, the upper and lower sections 921, 923 return to their initial state thereby clamping the proximal section 10 of the implantable lead (clamping state). The embodiment of a clamping device 920 comprises three wires 927, wherein each wire 927 extends from the outer surface of the lower section 923 through the wall of the lower section 923 into the inner lumen 924, where it runs along the inner surface of the lower section 923. Then, the wire 927 further extends through the wall of the upper section 921 to the outer surface of the upper section 921 and further to the outer surface of one wing 928. At wire 927 end section located at the wing 928 surface the alligator clip 40 may be fixed as shown in Fig. 20 establishing an electrical connection of the ring contact 11 to the PSA via wire 927. The eleventh embodiment of a three-piece clamping device 1020 depicted in fig. 21 to 23 is based on the 10th embodiment, wherein the first section of the clamping device 1020 corresponds to the 10th embodiment with an additional opening 1021b at one longitudinal end portion of the upper section 1021 and similarly an additional opening at one longitudinal end portion of the lower section 1023. The clamping device 1020 further comprises a second section 422 which is identical to the one explained with regard to the fifth embodiment 420. The clamping device 1020 further comprises an intermediate element 1023a comprising a protruding ring 1023c. For use with a terminal end section of an implantable lead the intermediate section 1023a is fixedly attached to the second section 422, in particular within the inner lumen of the second section 422. Then, this system is coupled with the first section, wherein the protruding ring 1023c is introduced into the openings 1021b and the corresponding opening of the lower section 1023 as shown in fig. 21 by arrow 31. The final state is shown in Fig. 22. The second section 422 is coupled wire the intermediate section 1023a to the first section such that the second section 423 is rotatable relative to the first section as shown by means of arrow 32 in fig. 22.

[0065] A twelfth embodiment of a clamping device 1120 is depicted in fig. 24 to 26. This embodiment comprises a first jaw-like section 1121 and a second, opposite jaw-like section 1123. Both jaw-like sections 1121 and 1123 connected by a bar-like central section 1121a. Further, the clamping device 1120 comprises three wires 1127 extending at the outer surface of the first jaw-like section 1121, over its end portion located opposite to the bar-like central section 112 la and to the end portion of the second jaw-like sections 1123 opposite the bar -like central section 1121a. The first and second jaw-like sections 1121 and 1123 are configured such that there is a force that drives them apart in their initial state. Their distance is determined by the length of the wires 1127 connecting the first and second jawlike sections 1121 and 1123. The inner lumen 1124 is located between the first jaw -like section 1121 and the second jaw-like section 1123. For introduction of the proximal section 10 of the implantable lead into the inner lumen 1124 the HCP presses the first and second jaw-like sections 1121 and 1123 against each other (see arrows 33 in fig. 25). The movement of the first jaw-like section 1121 into the direction of the second jaw-like section 1123 is limited by a protrusion 1123 a extending into the inner lumen and forming a stop surface for the opposite jaw-like section (here: the first jaw-like section 1121). Thereby, the wire 1127 is bent as shown in fig. 25 such that the proximal portion 10 of the implantable lead can be introduced into the inner lumen 1124 (open state). After introduction of the proximal portion 10 of the implantable lead into the inner lumen 1124 and the first and second jawlike sections 1121, 1123 are released, the implantable lead is clamped between the inner surfaces of the first and second jaw-like sections 1121, 1123 and the inner surface of each wire 1127 and an electrical connection is established between the ring contact 11 and the respective wire 1127 (see fig. 26, clamping state). The thirteenth embodiment of the clamping device 1220 is depicted in fig. 27 and is based on the twelfth embodiment of the clamping device 1120. With regard to the clamping device 1120 the thirteenth embodiment has an additional protruding flap 1228 located at the bar-like central section 1121a of the twelfth embodiment. The protruding flap 1228 comprises three contact pads 1229 wherein each of these pads 1229 is connected to one wire 1127 extending at the opposite surface of the first jaw-like section 1121. As indicated with regard to the embodiments explained above and having such protruding flap with contact pads, such pads provide a good electrical connection to an alligator clip due to its size.

Claims

1. Claims1. A clamping device (20, 120, 220, 320, 420, 520, 620, 720, 820, 920, 1020, 1120, 1220) configured for connection to a proximal portion (10) of an implantable lead having a number of N ring contacts (N > 1) (11) and a terminal pin (13), the clamping device comprising- a main body (21, 23, 328, 422, 423, 521, 523, 528, 621, 621a, 623, 721a, 728, 823a, 921, 923, 928, 1021, 1023a, 1121, 1121a, 1123, 1128) comprising an outer surface and an inner lumen (24, 624, 924, 1124) extending through the main body into a longitudinal direction, wherein the inner lumen is configured to accommodate the proximal portion of the implantable lead, wherein the main body is manufactured from electrically insulating material,- a number of M electrically conductive wires (27, 127, 227, 627, 727, 927, 1127), where M > N, extending along the outer surface, through the main body and within the inner lumen of the main body and extending transversely to the longitudinal direction, wherein the main body and / or the M wires is / are configured to adopt a clamping state in which a clamping connection to the proximal portion of the implantable lead is provided and in which each one of a pre-defined number of wires of the M wires provides an electrically conducting connection to one ring contact of the N ring contacts depending on the type of lead.

2. The clamping device of claim 1, wherein the main body and / or each wire is configured to adopt an open state in which the proximal portion of the implantable lead is free to slide within the inner lumen of the main body.

3. The clamping device of any one of the previous claims, wherein the main body comprises a first section and a second section (422) accommodated adjacently to the first section in longitudinal direction, wherein the first section comprises the M wires, wherein the second section is sized to frictionally engage a sealing section (14) of the implantable lead, wherein the second section is rotatable with respect to the first section about the longitudinal axis.

4. The clamping device of any one of the previous claims, wherein each wire is connected to a contact pad (329, 729, 1229) accommodated at a protruding flap (328, 728, 1228) of the main body.

5. The clamping device of any one of the previous claims, wherein the wire (127) is configured such that it extends fully around the inner lumen.

6. The clamping device of any one of the previous claims, wherein the main body is configured to accommodate an alligator clip (40).

7. The clamping device of any one of claim 4, wherein the protruding flap of the main body is configured to accommodate an alligator clip (40).

8. The clamping device of any one of the previous claims, wherein the main body comprises an inner sleeve (23, 423, 523) and an outer sleeve (21, 321, 521) where one of the inner and the outer sleeves are concentrically rotatable with respect to the other sleeve of the inner and the outer sleeve.

9. The clamping device of claims 2 and 8, wherein the open state is realized in a first rotation state and the clamping state is realized in a second rotation state different from the first rotation state.

10. The clamping device of claim 9, wherein the inner sleeve (23, 423, 523) comprises a slit-like opening (25) configured to accommodate one wire of the M wires.

11. The clamping device of any one of the claims 1 to 8, wherein the main body comprises two jawlike sections (621, 623), wherein the inner lumen is formed between the jaw-like sections.

12. The clamping device of claim 11 and any of claims 2, 9 or 10, wherein the two jaw-like sections (621, 623) are configured such that by pushing them apart against a restoring force transitions the main body to the open state.

13. The clamping device of claim 2 and any one of the claims 3 to 12, wherein the main body (921, 923, 1121, 1121a, 1123) is configured such that a compressive force applied to the outer surface of the main body in the direction of the inner lumen and transversely or radially with respect to the longitudinal direction against a restoring force transitions the main body to the open state.

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