LEAD FOR NEUROMODULATION

Abstract

The present disclosure relates to a lead for neuromodulation and/or neurosensing, more in particular for neurostimulation and/or neurorecording, comprising at least one lead cable, at least one electrode section and at least one electrode placed in the electrode section, wherein the lead comprises an anchor, which are pre-attached to the lead (and configured to engage with tissue fixation instrument and/or hold a tissue fixation.

Claims

1. A lead for neuromodulation and/or neurosensing comprising at least one lead cable, at least one electrode section and at least one electrode placed in the electrode section, wherein the lead comprises an anchor, which is pre-attached to the lead and configured to engage with a tissue fixation apparatus and/or hold a tissue fixation.

2. The lead according to claim 1, wherein the anchor is a sleeve or sleeve-like section on an outer part of the lead cable, where the sleeve or sleeve-like section forms an outermost part of the lead cable.

3. The lead according to claim 2, wherein the anchor is overmolded over and/or is part of the outer part of the lead cable.

4. The lead according to claim 1, wherein the anchor is at least partially made of a thermoplastic material.

5. The lead according to claim 1, wherein the anchor is at least partially made of an elastomeric material.

6. The lead according to claim 1, wherein the anchor has an uneven outer side.

7. The lead according to claim 6, wherein the uneven outer side of the anchor is at least partially pearly and/or comprises recesses and ridges.

8. The lead according to claim 1, wherein the lead includes at least two anchors.

9. The lead according to claim 8, wherein under conditions where the lead includes the at least two anchors, a first anchor is closest to the electrode section is at a distal part of the lead cable.

10. The lead according to claim 8, wherein at least one of the at least two anchors is at a proximal part of the lead cable.

11. The lead according to claim 9, wherein between the first anchor closest to the electrode section and the electrode section is a free lead cable section without any anchor.

12. The lead according to claim 11, wherein the free lead cable section has a minimum length selected out of a range of approximately 5 mm, approximately 10 mm to 60 mm and/or that the anchor has a length of at least approximately 10 mm or more, or approximately 60 mm or more.

13. The lead according to claim 1, wherein the lead comprises a strain relief loop.

14. The lead according to claim 1, wherein the lead is a spinal cord neurostimulation lead, wherein the electrode section is an electrode paddle with an array of electrodes, and wherein lead is configured to be implanted in vicinity of the cervical or thoracic or lumbar or sacral section of the spinal cord.

15. The lead according to claim 1, wherein the electrode section of the lead comprises at least one anchor and/or is directly connected to at least one anchor.

16. A method of fixing a lead for neuromodulation and/or neurosensing, wherein the lead comprises at least one lead cable, at least one electrode section, and at least one electrode placed in the electrode section, and wherein the lead further comprises at least one anchoring section, wherein the method comprises the steps of: placing the lead at an implantation site of a subject; fixing the lead at the implantation site by means of a fixation instrument being engaged with a surrounding tissue of the subject and engaged with the at least one anchoring section.

17. The method of claim 16, wherein the at least one anchoring section comprises a sleeve or sleeve-like section on an outer part of the at least one lead cable, where the sleeve or sleeve-like section forms an outermost part of the lead cable; and wherein the at least one anchoring section is overmolded over and/or is part of the outer part of the lead cable.

18. The method of claim 16, wherein the at least one anchoring section is at least partially made of one or more of a thermoplastic material and/or an elastomeric material.

19. The method of claim 16, wherein the at least one anchoring section has an uneven outer side, and wherein the uneven outer side is at least partially pearly and/or comprises recesses and ridges, and wherein the method includes engaging the fixation instrument with the surrounding tissue and the at least one anchoring section via winding the fixation instrument around the ridges and where the fixation instrument is held in the recesses.

20. The method of claim 16, wherein the at least one electrode section of the lead is directly connected to the at least one anchoring section.

Description

BRIEF DESCRIPTIONS OF THE FIGURES

[0051] FIG. 1 shows a perspective view of a first embodiment of a lead according to the present disclosure.

[0052] FIG. 2 shows a perspective view of a second embodiment of a lead according to the present disclosure.

[0053] FIG. 3 show a perspective view of a third embodiment of a lead according to the present disclosure.

[0054] FIG. 4 shows a perspective view of a fourth embodiment of a lead according to the present disclosure.

[0055] FIG. 5 shows a perspective view of a fifth embodiment of a lead according to the present disclosure.

[0056] FIG. 6 shows a further view of a sixth embodiment of a lead according to the present disclosure.

[0057] FIG. 7 shows a further view of the embodiment of FIG. 6.

[0058] FIG. 8 shows a further view of a seventh embodiment of a lead according to the present disclosure.

[0059] FIG. 9 shows a flow chart of an example procedure of fixation of the lead.

DETAILED DESCRIPTION

[0060] FIG. 1 shows a perspective view of first embodiment of a lead 10 according to the present disclosure.

[0061] The lead 10 is a lead for neuromodulation and neurosensing, more in particular for neurostimulation and neurorecording.

[0062] The lead 10 comprises two lead cables 12, 14 and an electrode section 16 arranged on an electrode paddle 18.

[0063] Specifically, the lead 10 is a spinal cord neurostimulation lead.

[0064] The electrode paddle 18 is made of flexible material, for example comprising a silicone based material.

[0065] The electrode section 16 comprises three rows of electrodes 20, having an inner electrode row 22 in the middle of the electrode paddle 18 and two outer electrode rows 24, 26.

[0066] The electrode paddle 18 with the array of electrodes 20 is configured to be implanted in a vicinity of a lumbar section of a spinal cord, for example to be placed in a spinal canal.

[0067] In another example, such an electrode array or a similar electrode array may be used to be implanted in a cervical, thoracic, or sacral section of the spinal cord

[0068] Furthermore, the lead 10 comprises an anchoring means 28, which is pre-attached to the lead 10 and which is configured to engage with tissue fixation means (not shown) and hold a tissue fixation.

[0069] The tissue fixation with the tissue fixation means are selected from at least one of suture, suture fiber, clamp, bracket, staples or the like.

[0070] The anchoring means 28 is here a sleeve-like section on the outer part of the lead cable 14, here forming an outermost part of the lead cable 14.

[0071] Moreover, the anchoring means 28 are overmolded over and part of the outermost part of the lead cable 14.

[0072] The anchoring means 28 may at least partially be made of a thermoplastic material, especially a medical grade thermoplastic material, for example poly amide or poly ethylene polyurethane.

[0073] In another example, the anchoring means 28 is at least partially made of an elastomeric material, namely a medical grade elastomeric thermoplastic material, for example medical grade silicone.

[0074] Furthermore, the anchoring means 28 has a length 21. As an example, anchoring means 28 may have a length of approx. 100 mm or more, in some examples approx. 60 mm or more.

[0075] As can be seen in FIG. 1, the anchoring means 28 comprises an uneven outer side, i.e. it is pearly and comprises recesses 28a and ridges 28b. Also, it may be described as having a plurality of bumps, here identically shaped bumps 28b.

[0076] Between the anchoring means 28 (close to the electrode section 16 and the electrode paddle 18) and the electrode section is a free lead cable section 30 without anchoring means.

[0077] The free lead cable section 30 has a length of approx. 20 mm. As examples, the free lead cable section may have a minimum length selected from a range of approx. 5 mm, more in particular a length selected from a range of approx. 10 mm to 60 mm.

[0078] FIG. 2 shows a perspective view of a second embodiment of a lead 110 according to the present disclosure.

[0079] The lead 110 comprises each and every structural and functional feature as shown in FIG. 1 and as described above.

[0080] Similar or identical features have the same reference number, however increased by the value 100.

[0081] As an additional feature, the lead 110 comprises a second anchoring means or section 140.

[0082] The second anchoring section 140 is spaced apart from the first anchoring means 128 on the same lead cable 114.

[0083] The second anchoring means 140 is at the proximal part 150 of the lead cable 114 while anchoring means 128 is at the distal part 151 of the lead cable, so that the lead cable 114 may be anchored in a section close to a connection to an implantable pulse generator (IPG). Discussed herein, it may be understood that distal refers a part of the lead cable closer to the electrode section, while proximal refers to a part of the lead cable closer to the IPG.

[0084] FIG. 3 shows a perspective view of a third embodiment of a lead 210 according to the present disclosure.

[0085] The lead 210 comprises each and every structural and functional feature as shown in FIG. 1 and as described above.

[0086] Similar or identical features have the same reference number, however increased by the value 200.

[0087] As an additional feature, the lead 110 comprises an elongated anchoring means 228, which covers more than of the length of the lead cable 214. Thus, the same anchoring means 228 may be used for a fixation close to the proximal part and the distal part of the lead cable 214.

[0088] FIG. 4 shows a perspective view of a fourth embodiment of a lead 310 according to the present disclosure.

[0089] The lead 310 comprises each and every structural and functional feature as shown in FIG. 1 and as described above.

[0090] Similar or identical features have the same reference number, however increased by the value 300.

[0091] As an additional feature, the lead 310 comprises anchoring means 328 at each lead cable in the distal area of lead cables 312 and 314.

[0092] It is also possible, that there is on both lead cables a second proximal anchoring means likewise the second anchoring means 140.

[0093] FIG. 5 shows a perspective view of a fifth embodiment of a lead 410 according to the present disclosure.

[0094] The lead 410 comprises each and every structural and functional feature as shown in FIG. 1 and as described above.

[0095] Similar or identical features have the same reference number, however increased by the value 400.

[0096] As an additional feature, the lead 410 comprises a strain relief loop 440.

[0097] The whole strain relief loop 440 is covered with the anchoring means 428.

[0098] The function of the strain relief loop is to allow application of strain and tension in the lead cable 414 distal of the strain relief loop 440, so that strain and tension are not forwarded to the electrode paddle 418.

[0099] The electrode paddle 418 is here shown in FIG. 5 as being placed in the spinal canal 450 close to the lumbar spinal cord 452.

[0100] As can be also seen, the strain relief loop 440 is outside of the spinal canal 450 and also outside of the vertebrae 431. So, a fixation can be done with the tissue surrounding the vertebrae at this location.

[0101] FIG. 6 and FIG. 7 show a sixth embodiment of a lead 510 according to the present disclosure.

[0102] FIG. 7 shows the implanted lead 510 in an implantation site of a human vertebrae and spinal cord at a lumbar part of the spinal cord.

[0103] The lead 510 comprises each and every structural and functional feature as shown in FIG. 1 and as described above.

[0104] Similar or identical features have the same reference number, however increased by the value 500.

[0105] As additional features, the lead 510 comprises instead of anchoring means attached to the lead cable(s) two paddle anchoring means 528, which are directly attached and connected to the electrode section 516, here being formed on and arranged on the electrode paddle 518.

[0106] The two paddle anchoring means 528 are arranged here on both sides of the lead cable 514 or lead cables 514 (as shown in FIG. 7) at the proximal end or proximal part of the electrode paddle 518.

[0107] Moreover, the paddle anchoring means 528 is not attached to the lead cables 514 but only and directly connected to the electrode paddle 518.

[0108] Thus, the paddle anchoring means 528 are not linked (attached to) current-carrying parts such as lead bodies or the lead cable(s) in order to minimize applied constraint on electrical parts.

[0109] The attachment of the anchoring means to the electrode section may be done by molding, overmolding, gluing, or by forming a further integral part of the electrode section, for example by means of providing an extension or finger-like, wing-like, or outgrowing part or paddle-like part, which serves as anchoring means.

[0110] Here, at FIG. 7 anchoring means 528 are formed sleeve-like on a paddle-extension cable 528a as having a sleeve 528b with two wings 528c.

[0111] In each wing 528c there is a hole 528d to be attached with a suture fiber or a screw or a pin or clamp or any other suitable fixation means.

[0112] The paddle anchoring means 528 may be made of semi-rigid materials (non-metallic except for the screw or the fixation means) such as a thermoplastic and/or elastomeric material and may be additionally or alternatively in a sleeve like or half sleeve form with wings for any suitable fixation means.

[0113] FIG. 8 shows a seventh embodiment of a lead 610 according to the present disclosure.

[0114] The lead 610 comprises each and every structural and functional feature as shown in FIG. 6 and FIG. 7 and as described above.

[0115] Similar or identical features have the same reference number, however increased by the value 100 compared to the reference number of FIG. 6 and FIG. 7.

[0116] The only difference is the fact that the paddle anchoring means 628 are arranged in a middle section at the sides of the electrode paddle 618.

[0117] FIG. 9 shows a flow chart of an example procedure of fixation of the lead, here the lead 10.

[0118] The fixation of the lead 10 comprises the following steps:

[0119] Firstly, in step S1, the lead 10 is placed at the implantation site by a surgeon. Here, the surgeon positions the lead 10 with the electrode paddle 18 in the spinal canal, for example in a vicinity of a lumbar section of the spinal cord.

[0120] In the second step S2 the electrodes 22, 24, 26 and thus the placement of the electrode section 16 is controlled, for example, by several testings. For example, test stimulation patterns can be used and the response thereto checked. There may be iterations of this step. If the test confirms correct placement, then it is continued with third step S3.

[0121] By performing some tests in step S2 the correct and intended placement and position of the lead 10 with the electrode paddle 18 is confirmed.

[0122] Then, in the third step S3, the lead 10 is fixed at the implantation site by means of a fixation means being engaged with the surrounding tissue of the patient and engaged with the anchoring means 28.

[0123] For example, this can be done by engaging a suture with the anchoring means 28 and surrounding tissue. The suture fiber may then be wound around the bumps 28b and may be held in the recesses 28a.

[0124] In the fourth step S4 then the surgery is completed, i.e. by continuing with the implantation of other elements of an implantable medical system and/or finalization of the surgical intervention.

REFERENCES

[0125] 10 lead [0126] 12 lead cable [0127] 14 lead cable [0128] 16 electrode section [0129] 18 electrode paddle [0130] 20 electrode [0131] 22 inner electrode row [0132] 24 outer electrode row [0133] 26 outer electrode row [0134] 28 anchoring means [0135] 28a recess [0136] 28b ridge, bump [0137] 30 free lead cable section [0138] 110 lead [0139] 112 lead cable [0140] 114 lead cable [0141] 116 electrode section [0142] 118 electrode paddle [0143] 120 electrode [0144] 122 inner electrode row [0145] 124 outer electrode row [0146] 126 outer electrode row [0147] 128 anchoring means [0148] 128a recess [0149] 128b ridge, bump [0150] 130 free lead cable section [0151] 140 second anchoring means [0152] 210 lead [0153] 212 lead cable [0154] 214 lead cable [0155] 216 electrode section [0156] 218 electrode paddle [0157] 220 electrode [0158] 222 inner electrode row [0159] 224 outer electrode row [0160] 226 outer electrode row [0161] 228 anchoring means [0162] 228a recess [0163] 228b ridge, bump [0164] 230 free lead cable section [0165] 310 lead [0166] 312 lead cable [0167] 314 lead cable [0168] 316 electrode section [0169] 318 electrode paddle [0170] 320 electrode [0171] 322 inner electrode row [0172] 324 outer electrode row [0173] 326 outer electrode row [0174] 328 anchoring means [0175] 328a recess [0176] 328b ridge, bump [0177] 330 free lead cable section [0178] 410 lead [0179] 412 lead cable [0180] 414 lead cable [0181] 416 electrode section [0182] 418 electrode paddle [0183] 420 electrode [0184] 422 inner electrode row [0185] 424 outer electrode row [0186] 426 outer electrode row [0187] 428 anchoring means [0188] 428a recess [0189] 428b ridge, bump [0190] 430 free lead cable section [0191] 440 strain relief loop [0192] 510 lead [0193] 514 lead cable [0194] 516 electrode section [0195] 518 electrode paddle [0196] 528 anchoring means [0197] 528a paddle-extension cable [0198] 528b sleeve [0199] 528c wing [0200] 528d hole [0201] S1 step 1 of fixation method [0202] S2 step 2 of fixation method [0203] S3 step 3 of fixation method [0204] S4 step 4 of fixation method