WO2022069493A1

WO2022069493A1 - Atraumatic lug for fixing a neurostimulation electrode to a nerve

Info

Publication number: WO2022069493A1
Application number: PCT/EP2021/076700
Authority: WO
Inventors: Serge Renaux
Original assignee: Atrotech
Priority date: 2020-09-29
Filing date: 2021-09-28
Publication date: 2022-04-07
Also published as: FR3114491B1; FR3114491A1

Abstract

The invention relates to an atraumatic lug (10) for fixing a neurostimulation electrode (30) to or against a nerve (100), which has: - a longitudinal grommet for a wire, and - two holes passing all the way through the longitudinal grommet, and the lug surrounds and keeps the nerve and the electrode together by means of a wire attached to itself in a loop passing along the surface of the lug on the opposite side from the surface facing the nerve through the two through-holes and passing through the longitudinal grommet.

Description

ATRAUMATIC TAB FOR FIXING ON A NERVE OF A NEUROSTIMULATION ELECTRODE

TECHNICAL FIELD OF THE INVENTION

The invention belongs to the field of temporary or permanent implantable neurostimulation electrodes. The invention relates more particularly to an atraumatic tab for fixing such an implantable electrode to the nerve that it stimulates.

STATE OF THE ART

The neurostimulation electrodes concerned by the invention are electrodes surgically implanted around a nerve bundle to ensure its stimulation by means of a pulse generator.

These electrodes require a fixing means in order to be held in place so as to prevent any movement apart from the nerve or sliding which would be liable to induce a modification of the stimulation parameters.

The use of gutter-shaped electrodes that surround the nerve is known, but it requires additional operating time for dissection and a significant risk of irreparable damage to the nerve.

The use of a wire forming a loop close to the nerve and the electrode to fix the electrode against the nerve is also known. However, this technique requires sufficient surface around the nerve to secure the wire and is not possible if the nerve is free.

American patent application US2009/210042 is known, which discloses an electrode in which the fixing means functions similarly to a belt, the ends of which are connected by a wire.

We also know the American patent application US 2003/040785 which discloses a longitudinal sheath tied by a thread like a lace, starting from one end and going to the other end by means of eyelets.

In these two patent applications, the wire can come into contact with the nerve and damage it.

PRESENTATION OF THE INVENTION

The present invention aims to remedy this drawback. To this end, according to a first aspect, the present invention relates to an atraumatic tab for fixing a neurostimulation electrode on or against a nerve, the tab enveloping and holding the nerve and the electrode together, which comprises:

- a longitudinal thread loop, on the surface of the tongue opposite the surface facing the nerve, and

- two through holes on either side of the longitudinal loop the tab further comprising a wire attached to itself in a loop passing along the surface of the tab opposite to the surface facing the nerve, in the two through holes and in the longitudinal loop.

Thanks to these provisions, the wire does not exert direct pressure on the nerve, thus reducing the risk of trauma to the nerve and its inflammation and postoperative problems. The wire exerts pressure on the outer surface of the tongue and on the tubular electrode which in turn exerts pressure on the nerve and the electrode, allowing the nerve to be enclosed without causing injury.

In embodiments, the longitudinal wire loop has an elongated through-hole.

Thanks to these arrangements, the wire positioned in the oblong through-hole of the loop is held in place transversely by the longest edges of the oblong hole, on either side of the wire.

According to these embodiments, the longitudinal loop of the tongue surrounding the assembly formed by the nerve and by the neurostimulation electrode is preferably positioned facing the electrode.

Thanks to these arrangements, the wire positioned in the through-hole is in direct contact with the electrode, exerting pressure directly on the electrode. Maintaining the tab on the electrode is thus improved without damaging the nerve by direct contact between the wire and the nerve.

In embodiments, the length of the longitudinal loop is between 10% and 90% of the perimeter of the electrode.

In embodiments, the length of the longitudinal loop is between 20% and 80% of the perimeter of the electrode.

In embodiments, the length of the longitudinal loop is between 40% and 60% of the perimeter of the electrode.

Thanks to these provisions, the wire positioned in the through hole in direct contact with the electrode is constrained, by the dimensions of the through hole, to exert a direct pressure only on the electrode and thus prevents any direct pressure on the nerve which could cause injury.

In embodiments, the longitudinal wire loop includes a gutter.

Thanks to these provisions, the wire positioned in the gutter of the loop is held in place transversely by the edges of the gutter, on either side of the wire.

In some embodiments, the longitudinal yarn loop comprises at least two reliefs configured to constrain the lateral movement of the yarn disposed between the two said reliefs.

Thanks to these provisions, the wire positioned between the two reliefs is held in place transversely by said reliefs.

In some embodiments, the tab includes means for attaching its two ends together.

Thanks to these arrangements, the holding of the assembly formed by the nerve and by the neurostimulation electrode by the tab is improved.

In some embodiments, the means for attaching the two ends of the tab to each other comprises at least one through hole drilled on each end of the tab, linked together by a second wire.

In embodiments, the tab is a flexible tab.

Thanks to these arrangements, the tab can be rolled up easily around the periphery of the assembly formed by an electrode and a nerve to be stimulated.

In embodiments, the tab comprises a bioabsorbable material. Preferably, the tab consists entirely of bioresorbable materials.

Thanks to these provisions, a new operation to remove the tab is not necessary. This embodiment is particularly suitable when the neurostimulation electrode must be kept in place for a long time.

According to a second aspect, the present invention relates to a neurostimulation electrode comprising an atraumatic fixing tab described in the present application.

The aims, advantages and particular characteristics of the neurostimulation electrode which is the subject of the present invention being similar to those of the tongue which is the subject of the present invention, they are not repeated here. BRIEF DESCRIPTION OF FIGURES

Other advantages, aims and particular characteristics of the invention will emerge from the non-limiting description which follows of at least one particular embodiment of the tongue and of the neurostimulation electrode which are the subject of the present invention, with reference to the drawings. annexes, in which:

- Figure 1 shows, schematically and in perspective view, a particular embodiment of a tongue object of the present invention, attaching the assembly formed by a neurostimulation electrode and a nerve,

- Figure 2 shows, schematically and in perspective view, a particular embodiment of the tongue object of the present invention, illustrated in isolation with suture son positioned according to a particular mode of implementation and

FIG. 3 represents, schematically and in sectional view, a particular embodiment of the tongue which is the subject of the present invention.

DESCRIPTION OF EMBODIMENTS

This description is given on a non-limiting basis, each characteristic of an embodiment being able to be combined with any other characteristic of any other embodiment in an advantageous manner.

We note, from now on, that the figures are each to scale, but that between them, the scales can vary.

It is noted that, within the meaning of the invention, the wire is a biocompatible elongated link. Preferably, the thread is a suture thread of the type usually used in surgical practice.

The outer surface of the tongue is defined as the surface opposite the surface in contact with the nerve. The internal surface of the tongue is defined as the surface facing or in contact with the nerve.

It should be noted that the atraumatic tab that is the subject of the invention may also be called “atraumatic fixing clip”.

The term gutter designates a blind hole, for example of oblong shape, drilled in the outer face of the tongue.

A flexible object is defined as an object which can be deformed by the application of a force of less than ten newtons, preferably less than one newton. In the context of the invention, the tab is configured to be deformed in order to be passed around the assembly formed by an electrode and a nerve to be stimulated.

FIG. 1 shows a schematic perspective view of a particular embodiment of the tab 10 which is the subject of the present invention, attaching together a neurostimulation electrode 30 and a bundle of nerves 100. The bundle of nerve fibers 100 will be also referred to as nerve 100 in this specification.

In other words, FIG. 1 illustrates a neurostimulation electrode 30 comprising a particular embodiment of the tab 10 for atraumatic fixation, according to the invention.

The neurostimulation electrode 30 is a tubular electrode comprising a plurality of contactors 35, 36, 37 and 38 configured to deliver electrical impulses to the nerve 100. The electrode 30 is described by way of example, any type of electrode can be implemented without deviating from the scope of the invention.

The placement of the tongue around the assembly formed by the electrode 30 and the nerve to be stimulated 100 is carried out by surgical methods comprising the drilling of small windows in the tissues (pleura, fatty tissue) around the nerve and the insertion of the tab 10 and a wire in the pierced windows. Once the tongue is positioned, the wire 20 is attached to itself in a loop passing along the surface of the tongue opposite the surface facing the nerve, in two through holes, 24 and 26, and in a longitudinal loop 22. The wire 20 is then gradually tightened until the tab is satisfactorily tightened around the assembly formed by the electrode 30 and the nerve to be stimulated 100. In some cases, the tab may be positioned directly against the nerve.

It is also emphasized that a plurality of tabs 10 could be used together at different locations of nerve 100 and electrode 30 to attach nerve 100 and electrode 30 together. In particular, the number of tabs can be adapted according to the number of contactors present on the neurostimulation electrode.

The characteristics of the tongue will be better understood with regard to Figures 2 and 3, which schematically represent, respectively in perspective and in section view, a particular embodiment of the tongue 10.

The tongue 10 comprises a longitudinal loop 22 for wire and two through holes 24, 26 on either side of the longitudinal loop 22. Thus, the tongue wrapped around the assembly formed by an electrode 30 and a nerve 100 makes it possible to bind this assembly by means of a wire 20 attached to the circumference of the tongue.

The wire 20 is positioned along the outer face of the tongue 10 and positioned in the longitudinal loop 22. The longitudinal loop makes it possible to avoid a transverse movement of the wire 20 and to reinforce the attachment of the electrode 30 with the nerve 100. The thread 20 is then passed through two through holes, 24 and 26, drilled in the tongue 10 on either side of the longitudinal loop 22. The thread 20 thus positioned is attached to itself by a knot of so as to form a loop around the tongue 10 which envelops the assembly formed by the neurostimulation electrode and the nerve.

In other words, tab 10 wraps and holds together nerve 100 and electrode 30 by means of a wire 20 attached to itself in a loop passing along the surface of the tab opposite the surface in facing or in contact with the nerve 100, in the two through holes, 24 and 26, and in the longitudinal loop 22.

Preferably the tongue 10 is a flexible tongue, it will however be possible to implement a rigid tongue without departing from the scope of the invention.

In the particular embodiment illustrated in Figures 1 to 3, the longitudinal loop 22 for wire has a through hole drilled in a central part 12 of the tongue 20. The through hole is oblong in shape and the great length of said through hole does not not exceed 60% of the circumference of the electrode 30 which in this particular case has a round section. Preferably, the central part 12, or in any case the pierced part of the oblong hole is positioned at the level of the electrode 30 during its installation.

In other embodiments (not shown), the longitudinal thread loop 22 includes a gutter.

In other embodiments (not shown), the longitudinal loop 22 for thread comprises at least two reliefs configured to constrain the lateral movement of the thread placed between the two said reliefs.

In some embodiments, the tab further comprises means for attaching its two ends together. In the embodiment illustrated in FIG. 1 to 3, the means for attaching the two ends of the tab together comprises four through holes two by two drilled on each end, 14 and 16, of the tab 10. A second wire 28 and passed successively through said four holes and then attached to itself by a knot, so as to bind the ends, 14 and 16, of the tongue 10 together. In embodiments, the length of the longitudinal loop 22 is between 10% and 90% of the perimeter of the electrode 30, more preferably the length of the longitudinal loop 22 is between 20% and 80% of the perimeter of the electrode 30 and even more preferably, the length of the longitudinal loop 22 is between 40% and 60% of the perimeter of the electrode 30.

In embodiments, tab 10 is formed at least in part from a bioabsorbable material. For some embodiments, it is preferable to use a tab and a wire made entirely of bioabsorbable material. For example, a bioresorbable material used is a derivative of polyglycolic acid, polylactic acid or polydioxanone.

Preferably, the tongue 10 is flexible.

Claims

8 CLAIMS

1 . Atraumatic tab (10) for fixing a neurostimulation electrode (30) on or against a nerve (100), the tab enveloping and holding together the nerve and the electrode, which comprises:

- a longitudinal loop (22) for thread, on the surface of the tongue opposite the surface facing the nerve, and

- two through holes (24, 26) on either side of the longitudinal loop, characterized in that it further comprises: a wire (20) attached to itself in a loop passing along the surface of the tab opposite the surface facing the nerve, in the two through holes and in the longitudinal loop (22).

2. Tab (10) according to claim 1, wherein the longitudinal loop (22) for wire has an oblong through hole.

3. Tongue (10) according to claim 2, in which the longitudinal loop (22) of the tongue surrounding the assembly formed by the nerve and by the neurostimulation electrode is preferably positioned facing the electrode.

4. Tongue (10) according to one of claims 1 to 3, wherein the longitudinal loop (22) for wire comprises a gutter.

5. Tongue (10) according to one of claims 1 to 4, wherein the longitudinal loop (22) for wire comprises at least two reliefs configured to constrain the lateral movement of the wire disposed between the two said reliefs.

6. Tongue (10), according to one of claims 1 to 5, wherein the length of the longitudinal loop (22) is between 10% and 90% of the perimeter of the electrode (30).

7. Tongue (10), according to claim 6, in which the length of the longitudinal loop (22) is between 20% and 80% of the perimeter of the electrode. 9

8. Tongue (10), according to claim 7, in which the length of the longitudinal loop (22) is between 40% and 60% of the perimeter of the electrode.

9. Tongue (10) according to one of claims 1 to 8, which further comprises means for attaching its two ends together.

10. Tongue (10) according to claim 9, wherein the means for attaching its two ends together comprises at least one through hole drilled on each end of the tongue, linked together by a second wire (28).

11. Tongue (10) according to one of claims 1 to 10, wherein the tongue is flexible.

12. Tongue (10) according to one of claims 1 to 11, comprising a bioresorbable material.

13. Tongue (10) according to claim 12, made entirely of bioresorbable material.

14. Neurostimulation electrode (30) comprising an atraumatic fixing tongue (10) according to one of claims 1 to 13.