Implant accessory and flexible implantable stimulation lead assembly - Patents.com

Abstract

The present invention relates to an assembly of an implant accessory and a flexible implantable stimulation lead including a needle 13. When a first portion 24 of the lead 14 is inserted into a lumen 17 of the needle 13, the first portion 24 of the lead 14 has at least a first branch 26 extending from the lead body 16 in a direction D toward the sharp free end 15 of the needle 13. The first branch 26 extends from the lead body 16 a predetermined distance L1 from the distal end 22, and a portion of the first branch 26 corresponding to the distance L1 forms a second portion 28 of the lead body 16 between the first branch 26 and the distal end 22 of the lead 14.

Description

[Technical Field]

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

[0002] The present invention also relates to a method for implanting such a lead through the heart wall, particularly the right ventricular free wall. [Background technology]

[0003] It is known to stimulate the right ventricle of the heart by inserting and receiving a so-called endocardial lead through the venous network into the chamber, or by using a so-called intracavitary lead that is implanted within the chamber by venous access.

[0004] It is also known to use so-called epicardial leads, which are attached directly to the outer wall of the myocardium, but epicardial leads often have inferior performance, especially in terms of electrical performance, compared to endocardial leads.

[0005] Additionally, while it is known to maintain epicardial leads in the epicardial wall by suturing or screwing in the lead's helical fixation screw, these mechanical fixators have the disadvantage of being invasive and relatively traumatic to the tissue.

[0006] Thus, the greatest drawback of known epicardial leads is the invasiveness of the procedure compared to intracavitary leads.

[0007] Furthermore, another drawback common to these known epicardial leads, besides being invasive to implant, is their poor electrical performance, which impairs the effectiveness of stimulation.

[0008] The present invention aims to overcome the various limitations mentioned above by proposing a stimulation lead that allows for improved stimulation efficacy while reducing the invasiveness of lead implantation.

[0009] The object of the present invention is achieved by using an assembly of an implant accessory and a flexible implantable stimulation lead. Flexible Implantable Stimulator The lead comprises a lead body, which can be connected to an active implantable medical device through its proximal end, and a distal end but The implant accessory is configured to be implanted through the heart wall, particularly through the right ventricular free wall. The implant accessory comprises a needle having a sharp puncture free end, at least a distal portion of the needle being hollow with a lumen opening at the sharp puncture free end. Flexible Implantable Stimulator At least a first portion of a lead extends from its distal end into the lumen of the needle. From the sharp puncture free end It is possible to insert Flexible Implantable Stimulator With the first portion of the lead inserted into the lumen of the needle, Flexible Implantable Stimulator The first portion of the lead extends from the lead body to the pointed end of the needle. puncture The lead body includes at least a first branch extending in a direction toward the free end, the first branch extending from a junction point disposed a predetermined distance from the distal end, and the portion corresponding to the distance is a portion of the first branch. The aforementioned Junction and Flexible Implantable Stimulator A second portion of the lead body is formed between the distal end of the lead and the distal end of the lead. The length of the second portion and the length of the first branch are substantially equal to each other.

[0010] The needle can then be used to puncture the right ventricular wall of the heart and introduce a lead therein. The lead comprises, at its distal end, a first branch and a second portion of the lead body, so that when the lead is implanted through the free wall of the right ventricle, the lead is provided with a retention means. The retention means of the lead can be inserted into the needle, thereby allowing it to be implanted in the tissue of the heart.

[0011] The lead is implantable through the right ventricular free wall so that the first branch and second portion of the lead body can be positioned within the right ventricle, particularly against the inner wall.

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

[0013] According to one embodiment, the lead body may further include a third portion having a lower stiffness than the first branch and the second portion, the third portion being less stiff than the first branch. The aforementioned From the junction Flexible Implantable Stimulator a first prong extending toward the proximal end of the lead, the first prong and the second prong extending toward the proximal end of the lead; , perpendicular to a plane including the first branch portion and the second portion The junction point Around the axis The rotating shaft is configured to rotate in a clockwise direction.

[0014] Thus, the first branch and the second section are fixed to each other during pivotal movement about the junction, which allows the retention means of the lead to be positioned against the right ventricle wall when the lead is implanted.

[0015] According to one embodiment, the Flexible Implantable Stimulator When the first portion of the lead 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] In this manner, the first branch is positioned to provide a retention means in the implanted state of the lead after the first branch and the second branch have been securely pivoted relative to one another about the junction point.

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

[0018] Thus, in an implanted state of the lead, at least one electrode, particularly the anode, may be positioned on the interior wall of the right ventricle, so that the anode is in direct contact with the heart wall, thereby improving stimulation.

[0019] According to one embodiment, the lead body comprises Flexible Implantable Stimulator Lead The aforementioned At least one electrode may be provided that is spaced from the junction by a length of 2 to 50 mm, particularly 2 to 30 mm.

[0020] This dimension therefore allows at least one electrode, particularly the cathode, to be positioned within the thickness of the heart wall, particularly the right ventricular free wall, during implantation of the lead, thereby improving both stimulation and sensing, and allowing stimulation to be delivered at lower energies than if the electrode were not in direct contact with the heart wall.

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

[0022] This dimension increases the contact surface of the retention means with the right ventricle wall, increasing retention of the lead through the right ventricle wall while allowing for easy and atraumatic removal of the device by continuous traction.

[0023] According to one embodiment, the lead body may include a resilient portion that is reinforced and resilient relative to the remainder of the lead body, the resilient portion being different from the first portion and having a resilient surface relative to the first portion. Flexible Implantable Stimulator This corresponds to the bent part of the lead. The flexible implantable stimulation lead is bent via the bending portion when the first portion is inserted into the needle lumen, and is straightened out by the elasticity of the bending portion when the first portion exits the needle lumen.

[0024] This improves the robustness of the lead even if the lead is bent at this location, thereby extending its lifespan.

[0025] Additionally, the resilience of the bend allows for easy automatic resilient deployment once the first portion of the lead moves out of the needle lumen and is no longer held against the inner wall of the needle lumen.

[0026] According to one embodiment, the Flexible Implantable Stimulator The first portion of the lead extends from the lead body to the Flexible Implantable StimulatorThe lead may further include abutment means formed by a second branch extending in a direction toward the distal end of the lead, the second branch extending from the lead body starting at a junction with the lead body that is different from the second portion and the first branch.

[0027] The abutting means prevents unwanted movement of the lead into the ventricle after implantation, thereby improving the retention of the lead against the heart wall. The abutting means actually abuts against the outer free wall of the right ventricle when the lead is implanted.

[0028] According to one embodiment, the joining point of the second branch to the lead body may be 1 to 30 mm away from the joining point of the first branch.

[0029] This dimension substantially corresponds to the thickness of the right ventricular heart wall. Thus, the lead is structurally configured such that, in the implanted state of the lead, the first and second branches protrude from the lead body on either side of the right ventricular free wall, and each branch can hold the lead in the myocardium.

[0030] According to one embodiment, the lead body may include at least one electrode disposed between a junction of the first branch and a junction of the second branch.

[0031] Thus, at least one electrode may be advantageously positioned within the thickness of the right ventricular free wall, thereby improving stimulation to the right ventricle.

[0032] According to one embodiment, the Flexible Implantable Stimulator The lead may be a flexible microwire having a conductive core coated with an electrically insulating layer, and the at least one electrode may be flexibility formed by the exfoliation of the microwire, flexibility The microwire diameter is 1 French (0.33 mm) or less.

[0033] Thus, the size of the microwires allows for minimally invasive lead implantation. In fact, the puncture through the cardiac tissue to introduce the microwires can be reduced to a diameter of approximately 1 French. This results in less tissue trauma during lead implantation and removal.

[0034] The object of the present invention is to With lead body Also achieved with flexible implantable stimulation leads . before Note Flexible Implantable Stimulator The lead can be connected to an active implantable medical device through its proximal end and to an active implantable medical device through its distal end. but It is configured to be implanted through the heart wall, particularly through the right ventricular free wall. Flexible Implantable Stimulator The lead is A lumen opening at the sharp puncture free end The needle includes a first portion configured to be inserted into the needle. from the distal end to the needle The lumen of to From the sharp puncture free end When inserted, Flexible Implantable Stimulator The needle is pointed toward the proximal end of the lead. puncture The lead body includes at least a first branch extending from the lead body in a direction toward the free end, the first branch extending from the lead body a predetermined distance from the distal end, the distance being a distance between the first branch and the Flexible Implantable Stimulator A second portion of the lead body is formed between the distal end of the lead and the distal end of the lead. The length of the second portion and the length of the first branch are substantially equal to each other.

[0035] The lead comprises a first branch and a second portion of the lead body at its distal end, so that when the lead is implanted through the right ventricular free wall, the lead is provided with a retention means that can be inserted into the needle and thereby implanted into cardiac tissue.

[0036] The lead can be implanted through the free wall of the right ventricle so that the first branch and second portion of the lead body are positioned within the right ventricle against the inner wall, thereby increasing the contact area between the lead and the myocardial wall and improving the electrical performance of the lead.

[0037] According to one embodiment, the Flexible Implantable Stimulator The first portion of the lead extends from the lead body to the Flexible Implantable Stimulator The lead may further include abutment means formed by a second branch extending in a direction toward the distal end of the lead, the second branch extending from the lead body starting at a junction with the lead body that is different from both the second portion and the first branch.

[0038] The abutting means prevents unwanted movement of the lead into the ventricle after implantation, thereby improving the retention of the lead against the heart wall. The abutting means actually abuts against the outer free wall of the right ventricle when the lead is implanted.

[0039] The invention and its advantages will be explained in more detail below using preferred embodiments, particularly on the basis of the drawings.

[0040] 1a is a partial schematic diagram of an assembly 10 of an implant accessory 11 and a flexible implantable stimulation lead 14 according to the present invention, with the lead in an unimplanted state. For clarity, components associated with the implant accessory 11 will be described using odd-numbered reference numerals, and components associated with the lead 14 will be described using even-numbered reference numerals.

[0041] Figure 1b is a partial schematic view of the flexible implantable stimulation lead 14 shown in Figure 1a, with the lead in an unimplanted state. Figures 1a and 1b will now be described in parallel.

[0042] The lead 14 includes a lead body 16 .

[0043] The lead 14 may be connected to an active implantable medical device 18 via a proximal end 20 of the lead 14 .

[0044] The lead 14 is configured to be implanted through the heart wall, particularly through the right ventricular free wall, from its distal end 22. The distal end 22 is opposite the proximal end 20 of the lead 14.

[0045] FIG. 1c is a schematic diagram of a flexible implantable stimulation lead 14 in the implanted state of the lead.

[0046] Components having the same reference numerals used to describe Figures 1a, 1b, and 1c refer to the same components, and redundant detailed descriptions for each of Figures 1a, 1b, and 1c will be omitted.

[0047] FIG. 1a shows a partial view of a needle 13 included in an implant accessory 11 according to the invention.

[0048] The needle 13 is provided with a sharp puncture free end 15. The sharp puncture free end 15 corresponds to the distal end of the needle 13.

[0049] The needle 13 is a hollow needle with a lumen 17 that opens into a sharp, piercing free end 15 at least in its distal part, ie at least in the part of the needle 13 shown in FIG. 1 a.

[0050] The implant accessory 11 according to the invention comprises plunger means (not shown in Figures 1a to 1c) which is received in and slidable within the lumen 17 of the needle 13. This plunger means is shown in Figures 2c and 2d and will be described in more detail below.

[0051] In accordance with the present invention, a first portion 24 of the lead 14 is insertable from its distal end 22 into the lumen 17 of the needle 13 .

[0052] FIG. 1 a shows the lead 14 with a first portion 24 of the lead 14 inserted into the lumen 17 of the needle 13 .

[0053] It should be noted that the height h shown in FIG. 1a between the needle 13 and the lead body 16 that is not inserted into the lumen 17 of the needle 13 is shown as non-zero for clarity of illustration only. To practice the present invention, one skilled in the art should understand that with the first portion 24 of the lead 14 inserted into the lumen 17 of the needle 13, the remainder of the lead body 16 extends along the outer wall 19 of the needle 13, and contact between the lead body 16 and the outer wall 19 of the needle 13 is possible, but not necessary.

[0054] The first portion 24 of the lead 14 includes at least a first branch 26 extending from the lead body 16 in a direction D toward the sharp free end 15 of the needle.

[0055] The first branch 26 extends from the lead body 16 a predetermined distance L1 from the distal end 22 of the lead 14. The portion of the lead body 16 that extends from the distal end 22 and has the length L1 forms a second portion 28 of the lead body 16 that is disposed between the first branch 26 and the distal end 22 of the lead 14.

[0056] As shown in Figure 1c, the first branch 26 and second portion 28 of the lead 14 function as a retention means for maintaining the lead 14 through the free wall VD' of the right ventricle VD. In the implanted state of the lead 14 shown in Figure 1c, the first branch 26 and second portion 28 of the lead 14 are positioned to extend longitudinally along the inner wall VD'' of the right ventricle VD.

[0057] 1b, the first branch 26 has a length l1 between the junction 32 of the first branch 26 with the lead body 16 and the free end 26a of the first branch 26. The length l1 is 2 to 20 mm.

[0058] The length L1 of the second portion 28 and the length l1 of the first branch 26 may be substantially equal to each other.

[0059] These dimensions allow for a larger contact surface of the retention means against the interior wall VD'' of the right ventricle VD, further improving retention of the lead 14 through the interior wall VD'' of the right ventricle VD. Additionally, the retention force can be generated by the stiffness of the retention means immediately adjacent the junction 32.

[0060] In one embodiment of the present invention, as shown in FIGS. 1a-1c, the lead body 16 may further comprise a third section 30 that is less rigid than the first branch 26 and the second section 28. The third section 30 extends toward the proximal end 20 of the lead 14, i.e., toward the needle-pointed free end 15 shown in FIG. 1a. The third section 30 extends from a junction 32 of the lead body 16 between the first branch 26 and the second section 28, and the first branch 26 and the second section 28 are configured to positively rotate (indicated by reference character R in FIGS. 1a and 1b) relative to each other about the junction 32 of the lead body 16. The length of the third section 30 can be adjusted based on the thickness of the myocardium at the target site.

[0061] Thus, the first branch 26 and the second portion 28 are fixed to one another during a rotational movement R about the junction 32. This rotational movement R allows the retention means of the lead 14 to be positioned against the interior wall VD″ of the right ventricle VD when the lead 14 is implanted, as shown in FIG. 1c.

[0062] As shown in FIG. 1a, which shows first portion 24 of lead 14 inserted into lumen 17 of needle 13, first prong 26 and second portion 28 form an obtuse angle O, and first prong 26 and third portion 30 form an acute angle A. An obtuse angle is an angle between 90° and 180°. In particular, obtuse angle O formed between first prong 26 and second portion 28 has a degree of approximately 135°.

[0063] As described above, the first branch 26 and second portion 28 of the lead 14 are configured to reliably rotate relative to one another about the junction point 32 of the lead body 16, so that an obtuse angle O between the first branch 26 and second portion 28 of the lead 14 is maintained when the lead 14 is implanted, as shown in FIG. 1c.

[0064] The obtuse angle O between the first branch 26 and the second portion 28 of the lead 14 allows the first branch 26 and the second portion 28 to be positioned along the inner wall VD'' of the right ventricle VD and provides a means for retaining the lead 14.

[0065] 1a-1c, the first portion 24 of the lead 14 may further comprise an abutment formed by a second branch 34 extending from the lead body 16 in a direction d toward the distal end 22 of the lead 14. The second branch 34 extends from the lead body 16 starting at a junction 36. The junction 36 is included in a portion of the lead body 16 that is distinct from both the second portion 28 and the first branch 26.

[0066] 1a, the junction point 36 is included in the third portion 30 of the lead 14. In variations, the junction point 36 is located on the lead body 16 beyond the third portion 30.

[0067] The second branch 34 of the lead 14 provides an abutment means (see FIG. 1c) that allows for improved retention of the lead 14 against the wall VD' of the right ventricle VD while preventing unwanted migration of the lead 14 into the right ventricle VD after implantation. The abutment means 34 actually abuts against the outer free wall VD* of the right ventricle VD in the implanted state of the lead 14, as shown in FIG. 1c.

[0068] 1b, the second branch 34 has a length l2 between the junction 36 of the second branch 34 with the lead body 16 and the free end 34a of the second branch 34. The length l2 is 2 to 20 mm.

[0069] The length l1 of the first branch 26 and the length l2 of the second branch 34 may be substantially equal to each other.

[0070] The junction point 36 of the second branch 34 with the lead body 16 is spaced from the junction point 32 of the first branch 26 by a length L2 of 1 to 30 mm.

[0071] This dimension substantially corresponds to the thickness of the heart wall VD' in the right ventricle VD. Thus, the lead 14 is structurally configured such that, when the lead 14 is implanted, the first branch 26 and the second branch 34 protrude from the lead body 16 on either side of the wall VD' of the right ventricle VD, and each branch 26, 34 can hold the lead 14 in the myocardium.

[0072] Lead 14 is a stimulation lead and therefore includes at least one stimulation electrode.

[0073] Alternatively, the lead 14 may include at least one sensing electrode.

[0074] Figures 1d to 1f show alternative embodiments of the first portion 24 of the lead 14, which comprises at least one electrode. These alternatives may be combined with one another. However, the present invention is not limited to the alternatives shown in Figures 1d to 1f.

[0075] For components having the same reference numerals as those already used to describe Figures 1a to 1c, a detailed description will be omitted, see the above description thereof.

[0076] Figure 1d shows a first portion 24 with only one branch 26. In this variation, the first branch 26 carries an electrode E1 and the distal end 22 of the second portion 28 carries an electrode E2.

[0077] Similar to Figure 1d, Figure 1e shows a first portion 24 with only one branch 26. In this variation, the distal end 22 of the second portion 28 includes an electrode E2, and the lead body 16 further includes an electrode E3 spaced a length L3 from the junction 32 of the lead 14. The length L3 is between 2 and 50 mm, and in particular between 2 and 30 mm.

[0078] The electrode E3 may be a cathode E3 preferably positioned proximal to the junction 32 on the lead 14 so as to position the cathode E3 within the thickness of the myocardium. Thus, the cathode E3 is in contact with the right ventricular wall within the thickness of the wall VD', rather than on the surface of the inner wall VD''.

[0079] Therefore, length L3 is defined as the distance between junction 32 and electrode E3 that maintains cathode E3 within the myocardium, i.e., within the thickness of wall VD'. In fact, it is preferable to position cathode E3 within the thickness of the right ventricle wall VD', since surface contact is susceptible to micromotion caused by heartbeat.

[0080] This dimension therefore makes it possible, in the implanted state of the lead, to position the electrode E3 within the thickness of the heart wall, in particular the right ventricular free wall, resulting in a further improved stimulation.

[0081] 1f shows the first portion 24 comprising the first branch 26 and the second branch 34. In this variation, the lead body 16 comprises an electrode E4 disposed between the junction 32 of the first branch 26 and the junction 36 of the second branch 34.

[0082] Thus, electrode E4 may be advantageously placed within the thickness of the right ventricular free wall, thereby improving stimulation to the right ventricle.

[0083] In a modified example, the retention function of the second branch 34 may be achieved by an elastic structure that follows the curved radius (radius 3 to 30 mm) of the lead body 16 starting from the electrode E4. The advantages of this modified example are that it reduces impact on the pericardial cavity and that the lead body 16 is oriented tangentially to the outer wall of the myocardium, thereby reducing stress on the lead body 16 (mechanical fatigue resistance). This curved structure may replace or complement the retention function of the second branch 34.

[0084] In another variation, the lead 14 may be provided with four electrically independent electrodes to optimize the stimulation / sensing system for a given implant site.

[0085] Furthermore, since the stimulation electrodes are in direct contact with the heart wall, stimulation with lower energy is possible.

[0086] The present invention also eliminates the need to introduce a lead into the right ventricular cavity to stimulate the right ventricle, making lead implantation minimally invasive and therefore avoiding alterations to the patient's vascular system.

[0087] Furthermore, according to one embodiment, the lead may be a flexible microwire having a conductive core coated with an electrically insulating layer, and at least one electrode may be formed by a peeled portion of the microwire. In this embodiment, the microwire has a diameter of up to 1 French (0.33 mm).

[0088] The dimensions of this microwire allow for even less invasive lead implantation.

[0089] The overwhelming advantage of this technology is, in fact, its minimally invasive nature. The very small diameter of the lead allows for the use of an 18- to 24-gauge needle, allowing placement via a subxiphoid puncture (a surgical opening requiring one or more sutures or other closure methods). This approach not only allows for a faster recovery for the patient, but also reduces the risk of infection.

[0090] Furthermore, the lead body 16 according to the present invention may include an elastic portion 3 that is reinforced and has elasticity relative to the remaining portion of the lead body 16. This elastic portion 3 is different from the first portion 24 and corresponds to the bending portion of the lead 14, as shown in Fig. 1a. Therefore, even if the lead is bent at this elastic portion 3, the robustness of the lead 14 can be improved, and thus the lifespan can be extended.

[0091] Implantation of lead 14 is further explained with reference to Figures 2a through 2k, which illustrate a method for implanting such a lead through the heart wall, and in particular through the right ventricular free wall.

[0092] For components having the same reference numerals as those already used to describe Figures 1a to 1c, a detailed description will be omitted, see above.

[0093] As shown in Figure 2a, in the first step of the implantation method according to the present invention, a first portion 24 of the lead 14 is inserted into the lumen 17 of the needle 13. The lead 14 is bent at the bend 3 as previously described in Figure 1a.

[0094] The needle 13 is inserted through the surface of the chest, and then the needle 13 is moved in the direction A to approach the wall VD' of the right ventricle.

[0095] The needle 13 is moved until the free puncture end 15 of the needle 13 punctures the wall VD' of the right ventricle, as shown in FIG. 2b.

[0096] Many guidance / identification systems can be used, including but not limited to, surface or transesophageal ultrasound, stimulation, identification of anatomical surfaces, and injection of contrast agent under image enhancement.

[0097] While the puncture free end 15 of the needle 13 is positioned inside the right ventricle VD, the plunger means 21 of the implant accessory according to the present invention pushes the first portion 24 of the lead 14 outwardly of the lumen 17 of the needle 13 in the direction A, as shown in FIG. 2c.

[0098] FIG. 2 d shows the next step where the first portion 24 of the lead 14 is substantially completely outside the lumen 17 of the needle 13 .

[0099] Thereafter, the plunger means 21 is retracted in a direction B opposite to the direction A, and the needle 13 is removed in the direction B from the wall VD'.

[0100] Thus, in the step of Figure 2e, the first portion 24 of the lead 14 is outside the needle 13 and within the right ventricle VD. The flexibility and resilience of the bending portion 3 causes the lead 14 to deploy until it reaches the configuration shown in Figure 2f, which corresponds to the configuration of Figure 1b described above.

[0101] Next, as shown in Figures 2g and 2h, the lead 14 is pulled slightly in direction B, which extends from inside the right ventricle towards the outside of the heart.

[0102] In the step of Figure 2i, the second branch 34 slides through the right ventricular wall VD' toward the outside of the heart in direction B. The orientation of the second branch 34, with its free end 34a pointing toward the distal end 22 of the lead 14, allows for easy removal of the second branch 34 in direction B.

[0103] The free end 26a of the first branch 26 abuts against the inner wall VD'' of the right ventricle VD. This abutment drives a rotation R of the lead 14 about the junction 32 of the first branch 26 and the second portion 28, as shown in FIG. 2i.

[0104] As shown in FIG. 2j, rotation R continues to rotate first branch 26 and second portion 28 of lead 14 approximately 90° relative to the initial position of needle 13 (FIG. 2a).

[0105] Simultaneously with the rotation of the first branch 26 and the second portion 28, the lead 14 continues to be pulled in direction B until the first branch 26 and the second portion 28 of the lead 14 abut against the inner wall VD'' of the right ventricle VD, as shown in FIG. 2k, thereby limiting the rotation to substantially 90°.

[0106] The obtuse angle O formed between the first branch 26 and the second portion 28 positions the first branch 26 and the second portion 28 of the lead 14 against the inner wall VD″ of the right ventricle VD, thereby preventing unwanted removal of the lead 14 in direction B. In fact, when the lead 14 is pulled in direction B, the first branch 26 and the second portion 28 of the lead 14 abut against the inner wall VD″ of the right ventricle VD. This abutment prevents unwanted removal of the lead 14 from the right ventricle.

[0107] Proper positioning of the lead 14 can be confirmed by electrical performance verifying proper positioning of the electrodes, or under ultrasound or image enhancement.

[0108] The second branch 34 functions as an abutting means, and the free end 34a of the second branch 34 abuts against the outer wall VD* of the heart.

[0109] The abutting means 34 prevents unwanted movement of the lead 14 in the direction A into the ventricle VD after implantation, thereby improving the state in which the lead 14 is maintained against the heart wall VD'. [Brief explanation of the drawings]

[0110] [Figure 1a] 1 is a partial schematic diagram of an assembly of an implant accessory and a flexible implantable stimulation lead according to the present invention in an unimplanted state of the lead; [Figure 1b] FIG. 1b is a partial schematic diagram of the flexible implantable stimulation lead shown in FIG. 1a in an unimplanted state of the lead. [Figure 1c]FIG. 1B is a schematic diagram of the flexible implantable stimulation lead shown in FIGS. 1a and 1b in an implanted state of the lead. [Figure 1d] 1A-1C are partial schematic views of the flexible implantable stimulation lead according to a first variant, respectively; [Figure 1e] 1A-1C are partial schematic views of the flexible implantable stimulation lead according to a second variant, respectively, of FIGS. 1A-1C. [Figure 1f] 1A-1C are partial schematic views of the flexible implantable stimulation lead according to a third variant, respectively, of FIGS. 1A-1C. [Figures 2a-2e] 1A-1C are schematic diagrams illustrating steps for implanting a lead according to the present invention. [Figures 2f-2k] 1A-1C are schematic diagrams illustrating steps for implanting a lead according to the present invention.

Claims

1. An assembly of an implant accessory and a flexible implantable stimulation lead (14), comprising: The flexible implantable stimulation lead (14) comprises a lead body (16); the flexible implantable stimulation lead (14) is connectable via its proximal end (20) to an active implantable medical device and configured at its distal end (22) to be implanted through the cardiac wall; The implant accessory comprises a needle (13) having a sharp piercing free end (15), At least the distal portion of the needle (13) is a hollow needle having a lumen (17) opening at the sharp puncture free end (15); At least a first portion (24) of the flexible implantable stimulation lead (14) is insertable from its distal end (22) into the lumen (17) of the needle (13) through the sharp piercing free end (15); When the first portion (24) of the flexible implantable stimulation lead (14) is inserted into the lumen (17) of the needle (13), the first portion (24) of the flexible implantable stimulation lead (14) comprises at least a first branch (26) extending from the lead body (16) in a direction toward the sharp puncture free end (15) of the needle (13); The first branch (26) is positioned at a predetermined distance (L １ ) extending from the lead body (16) at a junction (32) located at the distance (L １ ) forms a second portion (28) of the lead body (16) between the junction (32) of the first branch (26) and the distal end (22) of the flexible implantable stimulation lead (14); The length of the second portion (28) and the length of the first branch (26) are further characterized by being substantially equal to each other. assembly.

2. The lead body (16) further comprises a third portion (30) having a lower stiffness than the first branch (26) and the second portion (28); the third portion (30) extends from the junction (32) of the first branch (26) toward the proximal end (20) of the flexible implantable stimulation lead (14); 2. The assembly of claim 1, wherein the first branch (26) and the second portion (28) are configured to rotate about an axis passing through the junction (32) perpendicular to a plane containing the first branch (26) and the second portion (28).

3. 3. The assembly of claim 2, wherein when the first portion (24) of the flexible implantable stimulation lead (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), and the first branch (26) and the third portion (30) form an acute angle.

4. The first branch (26) and / or the second branch (28) are connected to at least one electrode (E １ , E ２ 4. The assembly of claim 1, further comprising:

5. The lead body (16) has a length (L) of 2 to 50 mm from the junction point (32) of the flexible implantable stimulation lead (14). ３ At least one electrode (E ３ 5. The assembly of claim 1, further comprising:

6. The first branch (26) and the second branch (28) each have a length (l) of 2 to 20 mm. １ , L １ 6. The assembly according to claim 1, further comprising:

7. the lead body (16) comprises a resilient portion (3) that is reinforced and resilient relative to the remainder of the lead body (16), the resilient portion (3) being different from the first portion (24) and corresponding to the bending portion (3) of the flexible implantable stimulation lead (14); 7. An assembly as described in any one of claims 1 to 6, wherein the flexible implantable stimulation lead (14) is bent via the bending portion (3) when the first portion (24) is inserted into the lumen (17) of the needle (13), and is straightened out by the elasticity of the bending portion (3) when the first portion (24) exits the lumen (17) of the needle (13).

8. the first portion (24) of the flexible implantable stimulation lead (14) further comprises abutment means formed by a second branch (34) extending from the lead body (16) in a direction (d) toward the distal end (22) of the flexible implantable stimulation lead (14); 8. The assembly of claim 1, wherein the second branch extends from the lead body starting at a junction point on the lead body, the junction point being distinct from both the second portion and the first branch.

9. The junction (36) of the second branch (34) with the lead body (16) is located at a length (L) of 1 to 30 mm from the junction (32) of the first branch (26). ２ 9. The assembly of claim 8, wherein the first and second electrodes are spaced apart by a distance of 1.5 mm.

10. The lead body (16) includes at least one electrode (E) disposed between the junction (32) of the first branch (26) and the junction (36) of the second branch (34). ４ 10. The assembly of claim 8 or 9, comprising:

11. 11. The assembly of claim 4, 5 or 10, wherein the flexible implantable stimulation lead (14) is a flexible microwire having a conductive core coated with an electrically insulating layer, the at least one electrode being formed by a peeled portion of the flexible microwire, and the flexible microwire having a diameter of 1 French (0.33 mm) or less.

12. A flexible implantable stimulation lead (14) having a lead body (16), the flexible implantable stimulation lead (14) is connectable via its proximal end (20) to an active implantable medical device and configured at its distal end (22) to be implanted through the cardiac wall; The flexible implantable stimulation lead (14) comprises a first portion (24) configured to be inserted into a needle having a lumen (17) opening into a sharp puncture free end (15), the first portion (24) comprising at least a first branch (26) extending from the lead body (16) in a direction (D) directed toward the proximal end (20) of the flexible implantable stimulation lead (14) and toward the sharp puncture free end (15) of the needle when the first portion (24) is inserted from the distal end (22) into the lumen (17) of the needle through the sharp puncture free end (15); The first branch (26) is positioned at a predetermined distance (L １ ) from the lead body (16) at the distance (L １ ) forms a second portion (28) of the lead body (16) between the first branch (26) and the distal end (22) of the flexible implantable stimulation lead (14); The length of the second portion (28) and the length of the first branch (26) are further characterized by being substantially equal to each other. Flexible implantable stimulation leads.

13. the first portion (24) of the flexible implantable stimulation lead (14) further comprises abutment means formed by a second branch (34) extending from the lead body (16) in a direction (d) toward the distal end (22) of the flexible implantable stimulation lead (14); 13. The flexible implantable stimulation lead of claim 12, wherein the second branch (34) extends from the lead body (16) starting at a junction (36) of the lead body (16), the junction (36) being different from both the second portion (28) and the first branch (26).

Images