Set of an implantation accessory and an implantable flexible stimulation probe

Abstract

The present invention relates to an assembly of an implantation accessory comprising a needle (13) and an implantable flexible stimulation probe. In a state where a first portion (24) of the probe (14) is inserted into the lumen (17) of the needle (13), said first portion (24) of the probe (14) comprises at least a first branch (26) which extends from the probe body (26) in a direction (D) oriented towards the pointed free end (15) of the needle (13), the first branch (26) extending from the probe body (16) from a predetermined distance (L1) from the distal end (22) forming a second portion (28) of the probe body (16) between the first branch (26) and the distal end (22) of the probe (14). Figure for abstract: Fig. 1a

Description

Title of the invention: Set of an implantation accessory and an implantable flexible stimulation probe

[0001] The present invention relates to an assembly of an implantation accessory and an implantable flexible stimulation probe for an active implantable medical device.

[0002] The present invention also relates to a method for implanting such a probe through a wall of the heart, in particular through the free wall of the right ventricle.

[0003] It is known to stimulate the right ventricle by placing a so-called endocardial probe in the right ventricle of the heart where it is introduced via the venous network, or by means of a so-called endocavitary probe implanted in the cavities via venous access.

[0004] It is also known to use so-called epicardial probes which are directly fixed to the outer wall of the myocardium. However, an epicardial probe often provides poorer results than those obtained using an endocardial probe, particularly in terms of electrical performance.

[0005] Furthermore, it is known to hold the epicardial probes to the wall of the epicardium by suturing or screwing a helical screw to anchor the probe, but these mechanical fixations have the disadvantage of being invasive and relatively traumatic for the tissues.

[0006] Thus, the most significant disadvantage of known epicardial probes is the invasive side of the intervention compared to endocavitary probes.

[0007] Furthermore, in addition to the invasive nature of their implantation, another drawback common to these known epicardial probes is their low electrical performance, which is detrimental to the effectiveness of the stimulation.

[0008] The invention aims to overcome the various limitations set out above, by proposing a stimulation probe making it possible to improve the effectiveness of the stimulation while reducing the invasive nature of its implantation.

[0009] The object of the present invention is achieved by means of a set of an implantation accessory and an implantable flexible stimulation probe. Said probe comprises a probe body, and is capable of being combined with an active implantable medical device via its proximal end and is configured to be implanted through a wall of the heart, in particular through the free wall of the right ventricle, via its distal end. The implantation accessory comprises a needle with a sharp free puncture end, the needle being at least in its distal portion a hollow needle comprising an internal lumen opening onto the free end pointed puncture, at least a first portion of the probe being capable of being inserted via its distal end into the internal lumen of the needle. In a state where the first portion of the probe is inserted into the lumen of the needle, said first portion of the probe comprises at least a first branch which extends from the probe body in a direction oriented towards the pointed free end of the needle, the first branch extending from the probe body from a junction point arranged at a predetermined distance from the distal end forming a second portion of the probe body between the junction point of the first branch and the distal end of the probe.

[0010] Thus, the needle makes it possible to puncture the wall of the right ventricle of the heart and to introduce the probe therein. The probe comprising at its distal end a first branch and a second portion of the probe body, said probe is thus provided with a retaining means when the probe is implanted through the free wall of the right ventricle. This means for retaining the probe is insertable into the needle by means of which it can be implanted in the cardiac tissue.

[0011] The probe being implantable through the free wall of the right ventricle, the first branch and the second portion of the probe body can be arranged in the right ventricle, in particular against the internal wall.

[0012] The present invention, relating to an assembly of an implantation accessory and an implantable flexible stimulation probe, can be further improved by the following embodiments.

[0013] According to one embodiment, the probe body may further comprise a third portion less rigid than said first branch and the second portion, the third portion extending towards the proximal end of the probe from the junction point of the first branch, so that the first branch and the second portion are configured to pivot integrally with each other relative to said junction point.

[0014] Thus, the first branch and the second portion are made integral with each other during a pivoting movement around the junction point. This pivoting makes it possible to position the means for retaining the probe against the internal wall of the right ventricle in an implanted state of the probe.

[0015] According to one embodiment, in a state where the first portion of the probe is inserted into the lumen of the needle, the first branch and the second portion may form an obtuse angle and the first branch and the third portion may form an acute angle.

[0016] Thus, the first branch is arranged so as to be able to provide a retaining means in an implanted state of the probe following the integral pivoting of the first branch and the second portion relative to the junction point.

[0017] According to one embodiment, the first branch and / or the second portion may comprise at least one electrode.

[0018] Thus, in an implanted state of the probe, the at least one electrode, in particular the anode, can be arranged on the inner wall of the right ventricle. As a result, thanks to the direct contact of the anode with the heart wall, stimulation can be improved.

[0019] According to one embodiment, the probe body may comprise at least one electrode which is spaced from the junction point of the probe by a length of between 2 and 50 mm, in particular between 2 and 30 mm.

[0020] Thus, these dimensions make it possible, in an implanted state of the probe, to arrange at least one electrode, in particular the cathode, in the thickness of the cardiac wall, in particular the free wall of the right ventricle. Thus, stimulation and detection are all the more improved. It is also made possible to stimulate at lower energies than when the electrodes are not in direct contact with the cardiac wall.

[0021] According to one embodiment, the first branch and the second portion may each have a length of between 2 and 20 mm.

[0022] These dimensions make it possible to improve the contact surface of the retaining means against the internal wall of the right ventricle and thus to increase the retention of the probe through the internal wall of the right ventricle, while allowing simple and damage-free removal of the device by sustained traction.

[0023] According to one embodiment, the probe body may comprise a zone that is reinforced and elastic relative to the rest of the probe body, said zone being distinct from the first portion and corresponding to a folding zone of the probe.

[0024] Thus, the robustness, and therefore the lifetime of the probe, can be increased despite the bending of the probe at this location.

[0025] In addition, the elasticity of this folding zone allows automatic elastic deployment and is therefore simple to implement, as soon as the first portion of the probe is moved out of the lumen of the needle and is no longer retained against the internal wall of the lumen of the needle.

[0026] According to one embodiment, the first portion of the probe may further comprise a support means formed by a second branch which extends from the probe body in a direction oriented towards the distal end of the probe, the second branch extending from the probe body from a junction point of the probe body distinct from said second portion and the first branch.

[0027] The support means makes it possible to improve the retention of the probe on the wall of the heart by preventing involuntary migration of the probe into the ventricle after implantation of said probe. The support means in fact bears against the free external wall of the right ventricle in the implanted state of said probe.

[0028] According to one embodiment, the junction point of the second branch with the probe body can be spaced between 1 and 30 mm from the junction point of the first branch.

[0029] These dimensions essentially correspond to the thickness of the heart wall at the level of the right ventricle. Thus, the probe is structurally configured so that the first branch and the second branch protrude from the probe body on either side of the free wall of the right ventricle in an implanted state of the probe, each of the branches making it possible to retain the probe to the heart muscle.

[0030] According to one embodiment, the probe body may comprise at least one electrode arranged between the junction point of the first branch and the junction point of the second branch.

[0031] Thus, the at least one electrode can be advantageously arranged in the thickness of the free wall of the right ventricle, which improves the stimulation of the right ventricle.

[0032] According to one embodiment, the probe may be a flexible microcable comprising an electrically conductive core coated with an electrically insulating layer, and the at least one electrode being formed by a stripped area of ​​the microcable and the diameter of the microcable being at most 1 French (0.33 mm).

[0033] Thus, thanks to the dimensions of the microcable, it is possible to make the implantation of the probe less invasive. Indeed, the puncture through the cardiac tissues to introduce the microcable can be reduced to a diameter of approximately 1 French. As a result, it is possible to cause less damage to the tissues during implantation and removal of the probe.

[0034] The object of the invention is also achieved by means of an implantable flexible stimulation probe for an assembly as described above. Said probe comprises a probe body. Said probe is capable of being combined with an active implantable medical device via its proximal end and being configured to be implanted through a wall of the heart, in particular through the free wall of the right ventricle, via its distal end. Said probe comprises a first portion configured to be inserted into a needle.The first portion includes at least a first leg extending from the probe body in a direction toward the proximal end of the probe and toward the sharp free end of the needle when the first portion is inserted into the needle, the first leg extending from the probe body a predetermined distance from the distal end forming a second portion of the probe body between the first leg and the distal end of the probe.

[0035] The probe comprising at its distal end a first branch and a second portion of the probe body, said probe is thus provided with a retaining means when the probe is implanted through the free wall of the right ventricle. This means for retaining the probe is insertable into the needle by means of which it can be implanted into heart tissue.

[0036] The probe being implantable through the free wall of the right ventricle, so that the first branch and the second portion of the probe body are arranged in the right ventricle, against the internal wall, the contact areas between the probe and the wall of the myocardium are increased, which makes it possible to improve the electrical performance of the probe.

[0037] According to one embodiment, the first portion of the probe may further comprise a support means formed by a second branch which extends from the probe body in a direction oriented towards the distal end of the probe, the second branch extending from the probe body from a junction point of the probe body which is both distinct from said second portion and from the first branch.

[0038] The support means makes it possible to improve the retention of the probe on the wall of the heart by preventing involuntary migration of the probe into the ventricle after implantation of said probe. The support means in fact bears against the free external wall of the right ventricle in the implanted state of said probe.

[0039] The invention and its advantages will be explained in more detail in the following by means of preferred embodiments and with particular reference to the following accompanying figures, in which:

[0040] [fig.la] [fig.la] represents a schematic and partial view of the assembly of an implantation accessory and an implantable flexible stimulation probe according to the present invention in a non-implanted state of the probe.

[0041] [fig.lb] [fig.lb] represents a schematic and partial view of the flexible implantable stimulation probe illustrated in [fig.la] in a non-implanted state of the probe.

[0042] [fig.lc] [fig.lc] represents a schematic view of the flexible implantable stimulation probe illustrated in Figures 1a and 1b in an implanted state of the probe.

[0043] [fig.ld] [fig.ld] represents a schematic and partial view of the flexible implantable stimulation probe illustrated in Figures la to le according to a first variant.

[0044] [fig.11] [fig.11] represents a schematic and partial view of the flexible implantable stimulation probe illustrated in Figures 1a to 1c according to a second variant.

[0045] [fig. If] [fig.lf] represents a schematic and partial view of the flexible probe implantable stimulation illustrated in Figures 1a to 1c according to a third variant.

[0046] [fig.2a] [fig.2a] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0047] [fig.2b] [fig.2b] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0048] [fig.2c] [fig.2c] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0049] [fig.2d] [fig.2d] represents a schematic view of a stage of the implantation of the probe according to the present invention.

[0050] [fig.2e] [fig.2e] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0051] [fig.2f] [fig.2f] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0052] [fig.2g] [fig.2g] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0053] [fig.2h] [fig.2h] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0054] [fig.2i] [fig.2i] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0055] [fig.2j] [fig.2j] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0056] [fig.2k] [fig.2k] represents a schematic view of a step in the implantation of the probe according to the present invention.

[0057] [Fig.1a] represents a schematic and partial view of the assembly 10 of an implantation accessory 11 and a flexible implantable stimulation probe 14 according to the present invention in a non-implanted state of the probe. For the sake of clarity, in the following, the elements relating to the implantation accessory 11 are described by odd references while the elements relating to the probe 14 are described with even references.

[0058] [Fig.lb] representing a schematic and partial view of the flexible implantable stimulation probe 14 illustrated in [Fig.la] in a non-implanted state of the probe, [Fig.la] and [Fig.lb] are described jointly below.

[0059] The probe 14 comprises a probe body 16.

[0060] The probe 14 is capable of being combined with an active implantable medical device 18 via the proximal end 20 of the probe 14.

[0061] The probe 14 is configured to be implanted via the distal end 22 of the probe 14 through a wall of the heart, in particular through the free wall of the right ventricle. The distal end 22 is opposite the proximal end 20 of the probe 14.

[0062] [Fig.lc] illustrates a schematic view of the flexible implantable stimulation probe 14 in an implanted state of the probe.

[0063] Elements with the same numerical references used for the description of [fig.1a], [fig.1b] and [fig.1c] refer to the same elements and will not be described again in detail for each of Figures 1a, 1b and 1c.

[0064] [Fig.1a] illustrates a partial view of a needle 13 included in the implantation accessory 11 according to the present invention.

[0065] The needle 13 is provided with a free pointed puncture end 15. The end 15 free pointed puncture corresponds to the distal end of the needle 13.

[0066] The needle 13 is at least in its distal part, that is to say at least the part of the needle 13 which is illustrated in [fig.1a], a hollow needle comprising an internal lumen 17 opening onto the free pointed puncture end 15.

[0067] The implantation accessory 11 according to the present invention also comprises a pusher means capable of being housed and sliding in the lumen 17 of the needle 13 (this pusher means is not shown in Figures 1a to 1c). This pusher means is visible in Figures 2c and 2d, which will be described in more detail below.

[0068] According to the present invention, a first portion 24 of the probe 14 is capable of being inserted via its distal end 22 into the internal lumen 17 of the needle 13.

[0069] [Fig. 1a] illustrates a state of the probe 14 in which the first portion 24 of the probe 14 is inserted into the lumen 17 of the needle 13.

[0070] Note that the height h illustrated in [fig.1a] between the needle 13 and the probe body 16 which is not inserted into the lumen 17 of the needle 13 is shown as being non-zero only for the sake of clarity for the illustration. It should be understood by those skilled in the art that for the implementation of the present invention, in the state in which the first portion 24 of the probe 14 is inserted into the lumen 17 of the needle 13, the remainder of the probe body 16 extends along the outer wall 19 of the needle 13, so that there is possible, but not necessary, contact between the probe body 16 and the outer wall 19 of the needle 13.

[0071] The first portion 24 of the probe 14 comprises at least one first branch 26 which extends from the probe body 16 in a direction D oriented towards the free pointed end 15 of the needle.

[0072] The first branch 26 extends from the probe body 16 from a predetermined distance L1 from the distal end 22 of the probe 14. The portion of the probe body 16 of length L1 from the distal end 22 forms a second portion 28 of the probe body 16 disposed between the first branch 26 and the distal end 22 of the probe 14.

[0073] As illustrated in Fig. 1c, the first branch 26 and the second portion 28 of the probe 14 serve as a retaining means for holding the probe 14 across a free wall RV' of the right ventricle RV. In the implanted state of the probe 14 shown in [Fig. 1c], the first branch 26 and the second portion 28 of the probe 14 are arranged to extend longitudinally along the inner wall RV” of the right ventricle RV.

[0074] As illustrated in [fig.lb], the first branch 26 has a length 11 between a junction point 32 of the probe body 16 of the first branch 26 and the free end 26a of the first branch. The length 11 is between 2 and 20 mm.

[0075] The length L1 of the second portion 28 and the length 11 of the first branch 26 can be substantially equal to each other.

[0076] These dimensions make it possible to improve the contact surface of the retaining means against the internal wall RV” of the right ventricle RV and thus to further increase the retention of the probe 14 through the internal wall RV' of the right ventricle RV”. In addition, the rigidity of the retaining means in the immediate vicinity of the junction point 32 makes it possible to generate retention.

[0077] In an embodiment of the present invention such as that illustrated in Figures 1a to 1c, the probe body 16 may further comprise a third portion 30 which is less rigid than the first branch 26 and the second portion 28. The third portion 30 extends towards the proximal end 20 of the probe 14, i.e. towards the free pointed end 15 of the needle in the representation of [fig.1a]. The third portion 30 extends from a junction point 32 of the probe body 16 between the first branch 26 and the second portion 28, such that the first branch 26 and the second portion 28 are configured to pivot (annotated by the reference R in Figures 1a and 1b) integrally with each other relative to the junction point 32 of the probe body 16. The length of the third portion 30 can be adapted according to the thickness of the cardiac muscle of the targeted region.

[0078] Thus, the first branch 26 and the second portion 28 are made integral with each other during a pivoting movement R around the junction point 32. This pivoting R makes it possible to position the means for retaining the probe 14 against the internal wall VD of the right ventricle VD in an implanted state of the probe 14, as illustrated in [fig.lc].

[0079] As illustrated in [fig.1a], which represents a state where the first portion 24 of the probe 14 is inserted into the lumen 17 of the needle 13, the first branch 26 and the second portion 28 form an obtuse angle O while the first branch 26 and the third portion 30 form an acute angle A. An obtuse angle is an angle whose measurement in degrees is between 90° and 180°. In particular, the obtuse angle O formed between the first branch 26 and the second portion 28 has a measurement in degrees of approximately 135°.

[0080] As described above, the first branch 26 and the second portion 28 of the probe 14 being configured to pivot integrally with one another relative to the junction point 32 of the probe body 16, the obtuse angle O between the first branch 26 and the second portion 28 of the probe 14 is preserved in the implanted state of the probe 14, as illustrated in [fig.lc].

[0081] The obtuse angle O between the first branch 26 and the second portion 28 of the probe 14 makes it possible to arrange the first branch 26 and the second portion 28 along the internal wall RV of the right ventricle RV and thus to provide a means of retaining the probe 14.

[0082] In an embodiment of the present invention such as that illustrated in Figures 1a to 1c, the first portion 26 of the probe 14 may further comprise a support means formed by a second branch 34 which extends from the probe body 16 in a direction d oriented towards the distal end 22 of the probe 14. The second branch 34 extends from the probe body 16 from a junction point 36. The junction point 36 is included in a portion of the probe body 16 which is both distinct from the second portion 28 and from the first branch 26.

[0083] In the embodiment illustrated in [fig.1a], the junction point 36 is included in the third portion 30 of the probe 14. In a variant, the junction point 36 is located on the probe body 16 beyond the third portion 30.

[0084] The second branch 34 of the probe 14 provides a support means which makes it possible to improve the retention of the probe 14 on the wall VD' of the right ventricle VD by preventing involuntary migration of the probe 14 into the right ventricle VD after implantation of the probe 14 (see [fig.lc]). The support means 34 in fact bears against the free external wall VD* of the right ventricle VD in the implanted state of the probe 14, as illustrated in [fig.lc].

[0085] As illustrated in [fig.lb], the second branch 34 has a length 12 between a junction point 36 of the probe body 16 of the second branch 34 and the free end 34a of the second branch 34. The length 12 is between 2 and 20 mm.

[0086] The length 11 of the first branch 26 and the length 12 of the second branch 34 may be substantially equal to each other.

[0087] The junction point 36 of the second branch 34 with the probe body 14 is spaced by a length L2 of between 1 and 30 mm from the junction point 32 of the first branch 26.

[0088] These dimensions essentially correspond to the thickness of the cardiac wall RV' at the level of the right ventricle RV. Thus, the probe 14 is structurally configured so that the first branch 26 and the second branch 34 project from the probe body 16 on either side of the wall RV' of the right ventricle RV in the implanted state of the probe 14, each of the branches 26, 34 making it possible to retain the probe 14 to the cardiac muscle.

[0089] The probe 14 being a stimulation probe, it comprises at least one stimulation electrode.

[0090] In a variant, the probe 14 may also comprise at least one detection electrode.

[0091] Figures 1d to 1f illustrate alternative embodiments of the first portion 24 of the probe 14 comprising at least one electrode. These alternative embodiments can be combined with each other. The present invention is not limited to the alternative embodiments illustrated in Figures 1d to 1f.

[0092] Elements with the same reference numerals already used for the description of Figures 1a to 1c will not be described again in detail, and reference is made to their descriptions above.

[0093] [Fig. 1d] illustrates a first portion 24 which comprises only one branch 26. In this variant, the first branch 26 and the distal end 22 of the second portion 28 each comprise an electrode E1, E2.

[0094] Like [fig.ld], [fig.le] illustrates a first portion 24 which comprises only a single branch 26. In this variant, the distal end 22 of the second portion 28 comprises an electrode E2 and the probe body 16 further comprises an electrode E3 spaced by a length L3 from the junction point 32 of the probe 14. The length L3 is between 2 and 50 mm, in particular between 2 and 30 mm.

[0095] The electrode E3 may be a cathode E3 which is preferentially located on the proximal side of the junction point 32 of the probe 14 in order to position the cathode E3 in the thickness of the cardiac muscle. Thus, there is contact of the cathode E3 with the right ventricle wall in the thickness of the RV wall rather than on the surface of the RV internal wall”.

[0096] The length L3 is thus defined as the distance between the junction point 32 and the electrode E3, so as to maintain the cathode E3 in the cardiac muscle, i.e. in the thickness of the RV' wall. Indeed, the surface contacts being more subject to micro movements due to the heartbeat, it is preferable to position the cathode E3 in the thickness of the wall of the right ventricle RV'.

[0097] Thus, these dimensions allow, in an implanted state of the probe, to arrange the electrode E3 in the thickness of the cardiac wall, in particular the free wall of the right ventricle. As a result, the stimulation is all the more improved.

[0098] [Fig. 1 f] illustrates a first portion 24 which comprises a first branch 26 and a second branch 34. In this variant, the probe body 16 comprises an electrode E4 arranged between the junction point 32 of the first branch 26 and the junction point 36 of the second branch 34.

[0099] Thus, the electrode E4 can be advantageously arranged in the thickness of the free wall of the right ventricle, which improves the stimulation of the right ventricle.

[0100] In a variant, the retaining function of the second branch 34 can be obtained via an elastic conformation according to a radius of curvature (3 to 30 mm radius) of the lead body 14 starting at the level of the electrode E4. The advantages of this variant lie in the fact of less impact on the pericardial sac and of orienting the lead body tangentially to the external wall of the muscle, a configuration less stressful for the lead body 14 (resistance to mechanical fatigue). This curvature can replace or supplement the retaining function of the second branch 34.

[0101] In another variant, the probe 14 can be provided with four electrical electrodes trically independent in order to optimize the stimulation / detection system for a given implantation area.

[0102] Since the stimulation electrodes are in direct contact with the heart wall, it is also possible to stimulate at lower energies.

[0103] The present invention also makes it possible to avoid having to introduce a probe into the cavity of the right ventricle for stimulation of the right ventricle. Implantation of the probe is thus made less invasive. The vasculature of the implanted patient is thus not altered.

[0104] Additionally, according to one embodiment, the probe may be a flexible microcable comprising an electrically conductive core coated with an electrically insulating layer, and the at least one electrode may be formed by a stripped area of ​​the microcable. In this embodiment, the diameter of the microcable is at most 1 French (0.33mm).

[0105] Thus, thanks to the dimensions of the microcable, it is possible to make the implantation of the probe even less invasive.

[0106] The main advantage of this technique lies in the micro-invasive aspect. Given the very small diameter of the probe, it is possible to use 18 to 24 gauge puncture needles allowing placement by subxiphoid puncture (without the need to perform a surgical opening requiring closure means such as the placement of one or more sutures). In addition to faster patient recovery, the advantage of this approach is a reduction in the risk of infection.

[0107] Furthermore, the probe body 16 according to the present invention may comprise a zone 36 that is reinforced and elastic relative to the rest of the probe body 16. This zone 36 is distinct from the first portion 24 and corresponds to a folding zone of the probe 14, as illustrated in [fig.1a]. Thus, the robustness, and therefore the lifespan of the probe 14, may be increased despite the folding of the probe at this location 36.

[0108] The implantation of the probe 14 is further described with reference to the description of the method for implanting such a probe through a wall of the heart, in particular through the free wall of the right ventricle by means of Figures 2a to 2k.

[0109] Elements with the same reference numerals already used for the description of Figures 1a to 1c will not be described again in detail, and reference is made to their descriptions above.

[0110] In the first step of the implantation method according to the present invention as illustrated in [fig.2a], a first portion 24 of the probe 14 is inserted into the lumen 17 of the needle 13. The probe 14 is folded at the level of the folding zone 36 as in [fig.1a] previously described.

[0111] Needle 13 is punctured from the thoracic surface and then brought close to the wall of the right ventricle RV' in direction A.

[0112] The needle 13 is moved until the free puncture end 15 of the needle 13 punctures the wall of the right ventricle VD' as illustrated in [fig.2b].

[0113] Many guidance / tracking systems can be used: surface or transesophageal ultrasound, stimulation, anatomical surface tracking, injection of contrast agent under image intensifier. This list is not exhaustive.

[0114] While the free puncture end 15 of the needle 13 is located inside the right ventricle RV, a pusher means 21 of the implantation accessory according to the present invention pushes the first portion 24 of the probe 14 in the direction A out of the lumen 17 of the needle 13, as illustrated in [fig.2c].

[0115] [fig.2d] represents a following step in which the first portion 24 of the probe 14 is almost entirely outside the lumen 17 of the needle 13.

[0116] The pusher means 21 is then retracted in a direction B opposite to the direction A and the needle 13 is withdrawn from the wall VD' in the direction B.

[0117] Thus, at the step of [fig.2e], the first portion 24 of the probe 14 is outside the needle 13 and is in the right ventricle RV. The flexibility and elasticity of the folding zone 36 causes the probe 14 to be deployed to the configuration illustrated in [fig.2f], which also corresponds to that of [fig.2b] previously described.

[0118] Next, as illustrated in Figures 2g and 2h, the probe 14 is lightly pulled in direction B. Direction B extends from the inside of the right ventricle to the outside of the heart.

[0119] At the step of [fig.2i], the second branch 34 slides through the wall of the right ventricle VD' towards the outside of the heart in the direction B. The orientation of the second branch 24, the free end 34a of which points towards the distal end 22 of the probe 14 makes it possible to facilitate the withdrawal movement in the direction B of the second branch 24.

[0120] The free end 26a of the first branch 26 comes to abut against the internal wall VD” of the right ventricle VD. This stop causes the pivoting R of the first branch 26 and of the second portion 28 of the probe 14 relative to the junction point 32 as illustrated in [fig.2i].

[0121] As illustrated in [fig.2j], the pivoting R continues so as to pivot the first branch 26 and the second portion 28 of the probe 14 by approximately 90° relative to the initial position in the needle 13 as illustrated in [fig.2a].

[0122] At the same time as the pivoting of the first branch 26 and the second portion 28, the probe 14 continues to be pulled in the direction B until the first branch 26 and the second portion 28 of the probe 14 come to bear against the internal wall VD” of the right ventricle CD as illustrated in [fig.2k], thus limiting the pivoting to an angle of essentially 90°.

[0123] The obtuse angle O formed between the first branch 26 and the second portion 28 makes it possible to prevent involuntary withdrawal of the probe 14 in the direction B by positioning the first branch 26 and the second portion 28 of the probe 14 in abutment against the internal wall RV” of the right ventricle CD. Indeed, when the probe 14 is pulled in the direction B, the first branch 26 and the second portion 28 of the probe 14 abut against the internal wall RV” of the right ventricle CD. This abutment prevents involuntary withdrawal of the probe 14 from the right ventricle.

[0124] The correct positioning of the probe 14 can be confirmed by the electrical performances attesting to the correct positioning of the electrodes or by an ultrasound check or under a brightness amplifier.

[0125] The second branch 34 serves as a support means, the free end 34a of the second branch 24 coming to abut against the external wall VD* of the heart.

[0126] The support means 34 makes it possible to improve the retention of the probe 14 on the RV wall of the heart by preventing involuntary migration of the probe 14 in the direction A into the RV ventricle after implantation of said probe.

Claims

Claims

1. Assembly of an implantation accessory and an implantable flexible stimulation probe, said probe (14) comprising a probe body (16), and said probe (14) being suitable for being combined with an active implantable medical device via its proximal end (20) and being configured to be implanted through a wall of the heart, in particular through the free wall of the right ventricle, via its distal end (22), the implantation accessory comprising a needle (13) with a free pointed puncture end (15), the needle (13) being at least in its distal part a hollow needle comprising an internal lumen (17) opening onto the free pointed puncture end (15), at least a first portion (24) of the probe (14) being suitable for being inserted via its distal end (22) into the internal lumen (17) of the needle (13),characterized in that in a state where the first portion (24) of the probe (14) is inserted into the lumen (17) of the needle (13), said first portion (24) of the probe (14) comprises at least a first branch (26) which extends from the probe body (16) in a direction (D) oriented towards the pointed free end (15) of the needle (13), the first branch (26) extending from the probe body (16) from a junction point (32) arranged at a predetermined distance (L1) from the distal end (22) forming a second portion (28) of the probe body (16) between the junction point (32) of the first branch (26) and the distal end (22) of the probe (14).,

2. An assembly according to claim 1, wherein the probe body (16) further comprises a third portion (30) less rigid than said first branch (26) and the second portion (28), the third portion (30) extending towards the proximal end (20) of the probe (14) from the junction point (32) of the first branch (26), such that the first branch (26) and the second portion (28) are configured to pivot integrally with each other relative to said junction point (32).

3. An assembly according to claim 2, wherein, in a state where the first portion (24) of the probe (14) is inserted into the lumen (17) of the needle (13), the first branch (26) and the second portion (28) form an obtuse angle (0) and the first branch (26) and the third portion (30) form an acute angle (A).

4. Assembly according to one of the preceding claims, in which the first branch (26) and / or the second portion (28) comprises at least one electrode (El, E2).

5. Assembly according to one of the preceding claims, in which the probe body (16) comprises at least one electrode (E3) which is spaced from the junction point (32) of the probe (14) by a length (L3) of between 2 and 50 mm, in particular between 2 and 30 mm.

6. Assembly according to one of the preceding claims, in which the first branch (26) and the second portion (28) each have a length (11, L1) of between 2 and 20 mm.

7. Assembly according to one of the preceding claims, in which the probe body (16) comprises a zone reinforced and elastic relative to the rest of the probe body, said zone being distinct from the first portion (28) and corresponding to a folding zone of the probe (14).

8. Assembly according to one of the preceding claims, in which the first portion of the probe (24) further comprises a support means formed by a second branch (34) which extends from the probe body (16) in a direction (d) oriented towards the distal end (22) of the probe (14), the second branch (34) extending from the probe body (16) from a junction point (36) of the probe body (16) which is both distinct from said second portion (28) and from the first branch (26).

9. An assembly according to claim 8, wherein the junction point (36) of the second branch (34) with the probe body (16) is spaced by a distance (L2) of between 1 and 30 mm from the junction point (32) of the first branch (26).

10. An assembly according to claim 8 or 9, wherein the probe body (16) comprises at least one electrode (E4) disposed between the junction point (32) of the first branch (26) and the junction point (36) of the second branch (34).

11. Assembly according to one of the preceding claims, in which the probe (14) is a flexible microcable comprising an electrically conductive core coated with an electrically insulating layer, and the at least one electrode (El, E2, E3, E4) being formed by a zone stripped of the microcable and the diameter of the microcable being at most 1 French (0.33mm).

12. An implantable flexible stimulation probe for an assembly according to one of the preceding claims, the probe (14) comprising a probe body (16), and said probe (14) being suitable for being combined with an active implantable medical device via its proximal end (20) and being configured to be implanted through a wall of the heart, in particular through the free wall of the right ventricle, via its distal end (22), the probe (14) comprising a first portion (24) configured to be inserted into a needle of the assembly according to one of the preceding claims, the first portion (24) comprising at least one first branch (26) which extends from the probe body (16) in a direction (D) oriented towards the proximal end (20) of the probe (14) and towards the pointed free end (15) of the needle when the first portion (24) is inserted into the needle,the first branch (26) extending from the probe body (16) from a predetermined distance (L1) from the distal end (22) forming a second portion (28) of the probe body (16) between the first branch (26) and the distal end (22) of the probe (14).,

13. An implantable flexible stimulation probe according to claim 12, wherein the first portion of the probe (24) further comprises a support means formed by a second branch (34) which extends from the probe body (16) in a direction (d) oriented towards the distal end (22) of the probe (14), the second branch (34) extending from the probe body (16) from a junction point (36) of the probe body (16) which is both distinct from said second portion (28) and from the first branch (26).

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