Assembly of implantable accessories and flexible implantable stimulation probes
By designing a flexible implantable stimulation probe assembly, the problems of high invasiveness and low electrical performance during epicardial probe implantation are solved, achieving stable implantation and efficient stimulation, and reducing tissue damage and infection risks.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- SORIN CRM
- Filing Date
- 2021-10-15
- Publication Date
- 2026-06-12
AI Technical Summary
Existing epicardial probes have problems with high invasiveness and low electrical performance during implantation, which affect the stimulation effect.
By employing implantable attachments and a flexible implantable stimulation probe assembly, a retention device is formed on the heart wall through the first branch and the second part of the probe body. Combined with the electrode design, this achieves stable implantation of the probe and improves its electrical performance.
It reduces the invasiveness of the implantation process, improves the stimulation effect, and achieves lower energy stimulation through direct contact between the electrode and the heart wall, reducing the risk of tissue damage and infection.
Smart Images
Figure CN116367884B_ABST
Abstract
Description
Technical Field
[0001] This invention relates to an implantable accessory and a flexible implantable stimulation probe for an active implantable medical device.
[0002] The present invention also relates to a method for implanting such a probe through the heart wall, specifically through the free wall of the right ventricle. Background Technology
[0003] It is known to stimulate the right ventricle by placing a so-called endocardial probe in the right ventricle of the heart, which is inserted into the right ventricle via a network of veins, or by using a so-called intracavitary probe implanted into the cavity via a venous access.
[0004] It is also known to use so-called epicardial probes, which are directly attached to the outer wall of the myocardium. However, epicardial probes generally produce worse results than endocardial probes, especially in terms of electrical performance.
[0005] In addition, it is known to hold the epicardial probe to the epicardial wall by suturing or tightening the helical anchoring screws of the probe, but these mechanical fasteners have the disadvantages of being invasive and relatively traumatic to the tissue.
[0006] Therefore, the biggest drawback of known epicardial probes is their invasiveness compared to intracardiac probes.
[0007] In addition to their invasiveness, another common drawback of these known epicardial probes is their low electrical properties, which are detrimental to the effectiveness of stimulation. Summary of the Invention
[0008] This invention attempts to overcome the aforementioned limitations by proposing a stimulation probe that allows for improved stimulation effectiveness while reducing the invasiveness of its implantation.
[0009] The present invention achieves its objectives using an implantable accessory and a flexible implantable stimulation probe. The probe includes a probe body and is capable of being combined with an active implantable medical device via its proximal end, and is configured for implantation via its distal end through the heart wall, specifically through the free wall of the right ventricle. The implantable accessory includes a needle with a pointed, free puncture end, at least a distal portion of which is a hollow needle including a lumen leading to the pointed, free puncture end, into which at least a first portion of the probe is insertable distally. With the first portion of the probe inserted into the lumen of the needle, the first portion of the probe includes at least a first branch extending from the probe body in a direction oriented toward the free end of the needle tip. This first branch extends from the probe body from a connection point located at a predetermined distance distally, thereby forming a second portion of the probe body between the connection point of the first branch and the distal end of the probe.
[0010] Therefore, the needle allows for puncture of the right ventricular wall of the heart and the insertion of a probe therein. Because the probe includes a first branch and a second portion of its distal body, it is equipped with a retention device when implanted through the free wall of the right ventricle. This retention device can be inserted into the needle, enabling the probe to be implanted into the heart tissue.
[0011] Because the probe can be implanted through the free wall of the right ventricle, the first branch and the second part of the probe body can be arranged in the right ventricle, specifically against the inner wall.
[0012] The present invention relates to components for implantable attachments and flexible implantable stimulation probes, which can be further improved through the following embodiments.
[0013] According to one embodiment, the probe body may further include a third portion that is less rigid than the first branch and the second portion, the third portion extending from the junction of the first branch toward the proximal end of the probe, such that the first branch and the second portion are configured to pivot firmly relative to the junction.
[0014] Therefore, during the pivoting motion around the connecting node, the first branch and the second part are fixed to each other. This pivoting allows the probe holding device to be positioned against the right ventricular wall while the probe is implanted.
[0015] According to one embodiment, with the first part of the probe inserted into the inner cavity of the needle, the first branch and the second part can form an obtuse angle, and the first branch and the third part can form an acute angle.
[0016] Therefore, the first branch is arranged to provide a holding device after the first and second branches have been firmly pivoted relative to each other with respect to the connection point while the probe is implanted.
[0017] According to one embodiment, the first branch and / or the second portion may include at least one electrode.
[0018] Therefore, with the probe implanted, at least one electrode, particularly the anode, can be positioned on the inner wall of the right ventricle. As a result, stimulation can be improved due to the direct contact between the anode and the heart wall.
[0019] According to one embodiment, the probe body may include at least one electrode spaced from the connection point of the probe by a length between 2 and 50 millimeters, specifically between 2 and 30 millimeters.
[0020] Therefore, these dimensions allow for the placement of at least one electrode, particularly a cathode, within the thickness of the heart wall, especially the free wall of the right ventricle, while the probe is implanted. This significantly improves stimulation and detection. Stimulation can also be performed at lower energies compared to when the electrode is not in direct contact with the heart wall.
[0021] According to one embodiment, the first branch and the second part may each have a length between 2 and 20 millimeters.
[0022] These dimensions allow for improved contact surface retention of the device against the right ventricular wall, thus increasing the retention of the probe through the right ventricular wall, while allowing for simple and non-destructive removal of the device by continuous traction.
[0023] According to one embodiment, the probe body may include a region that is reinforced and elastic relative to the rest of the probe body, the region being different from the first portion and corresponding to the bending region of the probe.
[0024] Therefore, even if the probe bends at this location, it can increase the probe's robustness and thus extend its lifespan.
[0025] Furthermore, the elasticity of the bending region allows for automatic elastic unfolding, thus making it easy to achieve once the first part of the probe is removed from the inner cavity of the needle and is no longer held against the inner wall of the needle's inner cavity.
[0026] According to one embodiment, the first portion of the probe may further include a support device formed by a second branch extending from the probe body in a direction oriented toward the distal end of the probe, the second branch extending from a junction of the probe body that is different from the second portion and the first branch.
[0027] The support device improves the maintenance of the probe's contact with the heart wall by preventing unnecessary migration of the probe into the ventricle after implantation. With the probe implanted, the support device effectively supports and abuts against the free wall of the right ventricle.
[0028] According to one embodiment, the connection point between the second branch and the probe body can be spaced 1 to 30 millimeters apart from the connection point of the first branch.
[0029] These dimensions essentially correspond to the thickness of the heart wall at the right ventricle. Therefore, the probe is structurally configured such that, in the implanted state, the first and second branches protrude from the probe body on either side of the free wall of the right ventricle, each branch enabling the probe to be held into the myocardium.
[0030] According to one embodiment, the probe body may include at least one electrode disposed between the connection point of the first branch and the connection point of the second branch.
[0031] Therefore, at least one electrode can be advantageously positioned within 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 microfilament comprising a conductive core coated with an electrically insulating layer, and at least one electrode formed by a stripped region of the microfilament, and the diameter of the microfilament is not greater than 1 Fr (0.33 mm).
[0033] Therefore, due to the size of the microfilaments, probe implantation can be less invasive. In fact, the diameter of the puncture for introducing microfilaments through cardiac tissue can be reduced to approximately 1 Fr. As a result, it is possible to cause less tissue damage during probe implantation and removal.
[0034] The object of the present invention is also achieved by means of a flexible implantable stimulation probe for the aforementioned components. The probe includes a probe body. The probe is capable of being combined with an active implantable medical device via its proximal end and configured to be implanted via its distal end through the heart wall, specifically through the free wall of the right ventricle. The probe includes a first portion configured to be inserted into a needle. This first portion includes at least a first branch that, when inserted into the needle, extends from the probe body in a direction oriented toward the proximal end of the probe and toward the free end of the needle tip, the first branch extending from the probe body at a predetermined distance from the distal end, thereby forming a second portion of the probe body between the first branch and the distal end of the probe.
[0035] Because the probe comprises a first branch and a second part of the probe body at its distal end, it is equipped with a retention device when implanted through the free wall of the right ventricle. This retention device can be inserted into a needle, by means of which the probe can be implanted into the heart tissue.
[0036] Because the probe can be implanted through the free wall of the right ventricle, the first branch and the second part of the probe body are arranged against the inner wall in the right ventricle, increasing the contact area between the probe and the myocardial wall, which allows for improved electrical properties of the probe.
[0037] According to one embodiment, the first portion of the probe may further include a support device formed by a second branch extending from the probe body in a direction oriented toward the distal end of the probe, the second branch extending from a junction of the probe body that is different from the second portion and the first branch.
[0038] This support device allows for improved maintenance of the probe's contact with the heart wall by preventing unnecessary migration of the probe into the ventricle after implantation. With the probe implanted, the support device effectively supports against the free wall of the right ventricle. Attached Figure Description
[0039] The invention and its advantages will be explained in more detail below using preferred embodiments and particularly based on the following drawings, in which:
[0040] Figure 1a A partial schematic diagram of the components of the implantable accessory and flexible implantable stimulation probe according to the present invention is shown in the non-implanted state of the probe.
[0041] Figure 1b It shows Figure 1a The diagram shows a partial view of the flexible implantable stimulation probe in its non-implanted state.
[0042] Figure 1c It shows Figure 1a and Figure 1b The diagram shows a partial view of the flexible implantable stimulation probe in its non-implanted state.
[0043] Figure 1d It shows the first variant Figures 1a to 1c A partial schematic diagram of the flexible implantable stimulation probe shown.
[0044] Figure 1e It shows the second variant Figures 1a to 1c A partial schematic diagram of the flexible implantable stimulation probe is shown.
[0045] Figure 1f It shows the third variant Figures 1a to 1c A partial schematic diagram of the flexible implantable stimulation probe is shown.
[0046] Figure 2a A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0047] Figure 2b A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0048] Figure 2c A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0049] Figure 2d A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0050] Figure 2e A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0051] Figure 2f A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0052] Figure 2g A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0053] Figure 2h A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0054] Figure 2i A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0055] Figure 2j A schematic diagram of the steps for implanting the probe according to the present invention is shown.
[0056] Figure 2k A schematic diagram of the steps for implanting the probe according to the present invention is shown. Detailed Implementation
[0057] Figure 1a A partial schematic diagram of the assembly 10 of the implantable accessory 11 and the flexible implantable stimulation probe 14 according to the present invention is shown in the probe-free state. For clarity, odd-numbered reference numerals are used hereinafter to describe elements related to the implantable accessory 11, and even-numbered reference numerals are used to describe elements related to the probe 14.
[0058] because Figure 1b It shows Figure 1a The diagram shows a partial schematic of the flexible implantable stimulation probe 14 in its non-implanted state, and therefore will be described in conjunction with it below. Figure 1a and Figure 1b .
[0059] The probe 14 includes a probe body 16.
[0060] The probe 14 can be combined with the active implantable medical device 18 via the proximal end 20 of the probe 14.
[0061] The probe 14 is configured to penetrate the heart wall, specifically the free wall of the right ventricle, via its distal end 22. The distal end 22 is opposite to the proximal end 20 of the probe 14.
[0062] Figure 1c A schematic diagram of the flexible implantable stimulation probe 14 in its implanted state is shown.
[0063] Used to describe Figure 1a , Figure 1b and Figure 1c Elements with the same reference numerals refer to the same element and will no longer be considered as such. Figure 1a , Figure 1b and Figure 1c Each of them is described in detail.
[0064] Figure 1a A partial view is shown of the needle 13 included in the implantation accessory 11 according to the invention.
[0065] The needle 13 has a pointed free puncture end 15. The pointed free puncture end 15 corresponds to the distal end of the needle 13.
[0066] At least the distal portion of needle 13, that is, at least in Figure 1a The portion of needle 13 shown is a hollow needle, which includes an inner cavity 17 leading to a free puncture end 15 at the tip.
[0067] The implant accessory 11 according to the invention further includes a plunger device capable of being received in and sliding within the lumen 17 of the needle 13. Figures 1a to 1c (Not shown in the image). This plunger device is in Figure 2c and Figure 2d As can be seen, this will be described in more detail below.
[0068] According to the present invention, the first portion 24 of the probe 14 can be inserted into the cavity 17 of the needle 13 via its distal end 22.
[0069] Figure 1a The state of probe 14 is shown, wherein the first portion 24 of probe 14 is inserted into the lumen 17 of needle 13.
[0070] It should be noted that Figure 1a The height h between the needle 13 and the probe body 16 not inserted into the cavity 17 of the needle 13 is shown as non-zero only for clarity of illustration. Those skilled in the art will understand that, for the purposes of this invention, with the first portion 24 of the probe 14 inserted into the cavity 17 of the needle 13, the remaining portion of the probe body 16 extends along the outer wall 19 of the needle 13, making contact between the probe body 16 and the outer wall 19 of the needle 13 possible, but not necessary.
[0071] The first portion 24 of the probe 14 includes at least a first branch 26 that extends from the probe body 16 in a direction D oriented toward the free end 15 of the needle tip.
[0072] The first branch 26 extends from the probe body 16 at a predetermined distance L1 from the distal end 22 of the probe 14. The portion of the probe body 16 at a distance L1 from the distal end 22 forms the second portion 28 of the probe body 16 disposed between the first branch 26 and the distal end 22 of the probe 14.
[0073] like Figure 1c As shown, the first branch 26 and the second portion 28 of probe 14 serve as a holding device to hold probe 14 through the free wall VD' of the right ventricle VD. Figure 1c In the implanted state of the probe 14 shown, the first branch 26 and the second part 28 of the probe 14 are arranged to extend longitudinally along the inner wall VD'' of the right ventricle VD.
[0074] like Figure 1b As shown, the length of the first branch 26 between the connection point 32 of the probe body 16 of the first branch 26 and the free end 26a of the first branch is l1. The length l1 is between 2 and 20 mm.
[0075] The length L1 of the second part 28 and the length l1 of the first branch 26 can be substantially equal to each other.
[0076] These dimensions allow for improved contact surface between the retaining device and the inner wall VD'' of the right ventricle VD, thereby further increasing the retention of the probe 14 through the inner wall VD'' of the right ventricle VD''. Furthermore, the rigidity of the retaining device immediately adjacent to the connection point 32 enables retention.
[0077] In embodiments of the present invention, such as Figures 1a to 1c In the illustrated embodiment, the probe body 16 may further include a third portion 30 with less rigidity than the first branch 26 and the second portion 28. The third portion 30 extends toward the proximal end 20 of the probe 14, i.e., toward... Figure 1a The free end 15 of the needle tip extends as shown. A third portion 30 extends from the connection 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 firmly relative to the connection point 32 of the probe body 16 (in... Figure 1a and Figure 1b (The figure is marked with R in the attached diagram). The length of the third part 30 can be adjusted based on the thickness of the myocardium in the target region.
[0078] Therefore, during the pivoting motion R around the connecting point 32, the first branch 26 and the second part 28 are fixed to each other. Figure 1c As shown, the pivot R enables the retaining device of the probe 14 to be positioned against the inner wall VD'' of the right ventricle VD when the probe 14 is implanted.
[0079] like Figure 1a As shown, the first portion 24 of the probe 14 is inserted into the cavity 17 of the needle 13, with the first branch 26 and the second portion 28 forming 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 measured in degrees, between 90° and 180°. Specifically, the obtuse angle O formed between the first branch 26 and the second portion 28 has a measured value of approximately 135°.
[0080] As described above, since the first branch 26 and the second part 28 of the probe 14 are configured to pivot firmly relative to each other relative to the connection point 32 of the probe body 16, the obtuse angle O between the first branch 26 and the second part 28 of the probe 14 is maintained in the implanted state of the probe 14, such as Figure 1c As shown.
[0081] The obtuse angle O between the first branch 26 and the second part 28 of the probe 14 allows the first branch 26 and the second part 28 to be arranged along the inner wall VD'' of the right ventricle VD, and thus provides a holding device for the probe 14.
[0082] In embodiments of the present invention, such as Figures 1a to 1c In the illustrated embodiment, the first portion 24 of the probe 14 may further include a support device formed by a second branch 34 extending from the probe body 16 in a direction d oriented toward the distal end 22 of the probe 14. The second branch 34 extends from a connection point 36 of the probe body 16. The connection point 36 is included in a portion of the probe body 16 that is different from the second portion 28 and the first branch 26.
[0083] exist Figure 1a In the illustrated embodiment, the connection point 36 is included in the third portion 30 of the probe 14. In a variant, the connection point 36 is located on the probe body 16 passing through the third portion 30.
[0084] The second branch 34 of probe 14 provides a support device that improves the retention of probe 14 to the wall VD' of the right ventricular VD, while preventing undesirable migration of probe 14 to the right ventricular VD after implantation (see...). Figure 1c With probe 14 implanted, the support device 34 actually supports and abuts against the outer free wall VD of the right ventricle. * ,like Figure 1c As shown.
[0085] like Figure 1b As shown, the length of the second branch 34 between the connection point 36 of the probe body 16 of the second branch 34 and the free end 34a of the second branch 34 is l2. The length l2 is between 2 and 20 mm.
[0086] The length l1 of the first branch 26 and the length l2 of the second branch 34 can be substantially equal to each other.
[0087] The connection point 36 between the second branch 34 and the probe body 16 is spaced 1 to 30 millimeters apart from the connection point 32 between the first branch 26 and the probe body 16.
[0088] These dimensions substantially correspond to the thickness of the cardiac wall VD' at the right ventricular VD. Therefore, the probe 14 is structurally configured such that, in the implanted state of the probe 14, the first branch 26 and the second branch 34 protrude from the probe body 16 on either side of the wall VD' of the right ventricular VD, each branch 26, 34 enabling the probe 14 to be held in the myocardium.
[0089] Because probe 14 is a stimulation probe, it includes at least one stimulation electrode.
[0090] In a variant, probe 14 may also include at least one detection electrode.
[0091] Figures 1d to 1f A variant embodiment of the first portion 24 of a probe 14 including at least one electrode is shown. These variants can be combined with each other. The invention is not limited to this. Figures 1d to 1f The variant shown.
[0092] The descriptions already used will no longer be described in detail. Figures 1a to 1c Elements having the same reference numerals are referred to above in the description of them.
[0093] Figure 1d The first portion 24, comprising only one branch 26, is shown. In this variant, the distal ends 22 of the first branch 26 and the second portion 28 each include electrodes E1 and E2.
[0094] like Figure 1d As shown, Figure 1e The diagram shows a first portion 24 comprising only one branch 26. In this variant, the distal end 22 of the second portion 28 includes an electrode E2, and the probe body 16 also includes an electrode E3 spaced apart from the connection point 32 of the probe 14 by a length L3. The length L3 is between 2 and 50 mm, specifically between 2 and 30 mm.
[0095] Electrode E3 may be a cathode E3, which is preferably located proximal to the connection point 32 of probe 14, so as to position the cathode E3 within the thickness of the myocardium. Thus, the cathode E3 contacts the right ventricular wall within the thickness of the wall VD' rather than on the surface of the inner wall VD''.
[0096] Therefore, length L3 is defined as the distance between connection point 32 and electrode E3, so as to maintain cathode E3 within the myocardium, i.e., within the thickness of wall VD'. In fact, since surface contact is more susceptible to the effects of micro-movements caused by heartbeat, cathode E3 is preferably positioned within the thickness of the wall of right ventricle VD'.
[0097] Therefore, these dimensions allow the electrode E3 to be positioned within the thickness of the heart wall, specifically within the thickness of the free wall of the right ventricle, while the probe is implanted. This results in further improved stimulation.
[0098] Figure 1f A first portion 24, including a first branch 26 and a second branch 34, is shown. In this variant, the probe body 16 includes an electrode E4 disposed between the connection point 32 of the first branch 26 and the connection point 36 of the second branch 34.
[0099] Therefore, electrode E4 can be advantageously positioned within the thickness of the free wall of the right ventricle, which improves stimulation of the right ventricle.
[0100] In a variation, the retaining function of the second branch 34 can be achieved via an elastic configuration along a curve radius (3 to 30 mm) of the probe body 16 originating from electrode E4. This variation offers the advantage of lower impact on the pericardial sac and tangential orientation of the probe body 16 to the outer wall of the muscle, resulting in less stress on the probe body 16 (resistance to mechanical fatigue). This curve can replace or supplement the retaining function of the second branch 34.
[0101] In another variant, probe 14 may be provided with four electrically independent electrodes in order to optimize the stimulation / detection system for a given implantation area.
[0102] Because the stimulating electrodes are in direct contact with the heart wall, lower energy stimulation can also be applied.
[0103] This invention also avoids the need to introduce a probe into the right ventricular cavity to stimulate the right ventricle. Therefore, probe implantation is less invasive. Consequently, the vascular system of the patient receiving the implant is not altered.
[0104] Furthermore, according to one embodiment, the probe may be a flexible microfilament comprising a conductive core coated with an electrically insulating layer, and at least one electrode may be formed from a stripped region of the microfilament. In this embodiment, the diameter of the microfilament is at most 1 Fr (0.33 mm).
[0105] Therefore, the size of the microfilaments makes it possible to implant probes with minimal invasiveness.
[0106] The overwhelming advantage of this technique lies primarily in its minimally invasive nature. Given the very small diameter of the probe, 18-gauge to 24-gauge needles can be used, allowing placement via subxiphoid puncture (without the need to create a surgical opening requiring closure devices, such as one or more sutures). In addition to faster patient recovery, this method also offers the advantage of a reduced risk of infection.
[0107] Furthermore, the probe body 16 according to the invention may include a region 3 that is reinforced and elastic relative to the rest of the probe body 16. This region 3 differs from the first portion 24 and corresponds to the bending region of the probe 14, such as... Figure 1a As shown. Therefore, even if the probe bends in this region 3, the robustness of the probe 14 can be increased and thus the lifespan of the probe 14 can be extended.
[0108] pass Figures 2a to 2k The implantation of probe 14 is further described with reference to the description of the method for implanting such a probe through the heart wall, specifically through the free wall of the right ventricle.
[0109] The descriptions already used will no longer be described in detail. Figures 1a to 1c The elements have the same reference numerals as those in the accompanying drawings, and refer to the description above.
[0110] In such Figure 2a In the first step of the implantation method according to the present invention, the first portion 24 of the probe 14 is inserted into the lumen 17 of the needle 13. The probe 14 bends at the bending region 3, as shown... Figure 1a As stated above.
[0111] The needle 13 is inserted through the surface of the chest and then close to the wall of the right ventricle VD' in direction A.
[0112] like Figure 2b As shown, move the needle 13 until the free puncture end 15 of the needle 13 punctures the wall of the right ventricle VD'.
[0113] Many guidance / identification systems can be used: surface or transesophageal ultrasound, stimulation, anatomical surface identification, and contrast agent injection under image intensifier. This list is not exhaustive.
[0114] When the free puncture end 15 of the needle 13 is located inside the right ventricle (VD), the plunger device 21 of the implantable accessory according to the present invention pushes the first portion 24 of the probe 14 outside the lumen 17 of the needle 13 in direction A, as... Figure 2c As shown.
[0115] Figure 2d The following steps are shown, wherein the first portion 24 of the probe 14 is actually completely outside the cavity 17 of the needle 13.
[0116] Then, the plunger device 21 retracts in direction B, which is opposite to direction A, and the needle 13 is removed from the wall VD' in direction B.
[0117] Therefore, in Figure 2e In this step, the first portion 24 of probe 14 is outside needle 13 and within the right ventricular VD. The flexibility and elasticity of the curved region 3 cause probe 14 to unfold until it reaches... Figure 2f The structure shown so far corresponds to the one described earlier. Figure 2b The structure.
[0118] Next, as Figure 2g As shown, then as Figure 2h As shown, probe 14 is slightly pulled in direction B. Direction B extends from the inside of the right ventricle to the outside of the heart.
[0119] exist Figure 2iIn this step, the second branch 34 slides outward toward the heart in direction B through the wall of the right ventricle VD'. The orientation of the free end 34a of the second branch 34 toward the distal end 22 of the probe 14 facilitates the removal motion of the second branch 34 in direction B.
[0120] The free end 26a of the first branch 26 abuts against the inner wall VD'' of the right ventricle VD. This abutment drives the first branch 26 and the second part 28 of the probe 14 to pivot R relative to the connection point 32, as shown. Figure 2i As shown.
[0121] like Figure 2j As shown, the pivot R continues to pivot the first branch 26 and the second portion 28 of the probe 14 approximately 90° relative to their initial positions in the needle 13, as... Figure 2a As shown.
[0122] As the first branch 26 and the second part 28 pivot, the probe 14 continues to be pulled in direction B until the first branch 26 and the second part 28 of the probe 14 support and abut against the inner wall VD'' of the right ventricular CD. Figure 2k As shown, this limits the pivoting angle to approximately 90°.
[0123] The obtuse angle O formed between the first branch 26 and the second portion 28 prevents unintended removal of the probe 14 in direction B by positioning the first branch 26 and the second portion 28 of the probe 14 against the inner wall VD'' of the right ventricular CD. In fact, when the probe 14 is pulled in direction B, the first branch 26 and the second portion 28 of the probe 14 are abutted against the inner wall VD'' of the right ventricular CD. This abutment prevents any unintended removal of the probe 14 from the right ventricle.
[0124] The correct positioning of probe 14 can be confirmed by electrical performance, proving the correct positioning of the electrode, or by ultrasound examination or image enhancement.
[0125] The second branch 34 serves as a support device, and the free end 34a of the second branch 34 abuts against the outer wall VD of the heart. * .
[0126] The support device 34 can improve the retention of the probe 14 to the heart wall VD by preventing the probe 14 from undesirably migrating into the ventricular VD in direction A after the probe is implanted.
Claims
1. An assembly for an implantable accessory and a flexible implantable stimulation probe, The probe (14) includes a probe body (16), and The probe (14) can be combined with an active implantable medical device via its proximal end (20) and is configured to be implanted via its distal end (22) through the free wall of the right ventricle. The implantable accessory includes a needle (13) with a pointed free puncture end (15). At least the distal portion of the needle (13) is a hollow needle, the hollow needle including an inner cavity (17) leading to a free puncture end (15) of the tip. At least a first portion (24) of the probe (14) is capable of being inserted into the lumen (17) of the needle (13) via its distal end (22). Its features are, With the first portion (24) of the probe (14) inserted into the lumen (17) of the needle (13), the first portion (24) of the probe (14) includes at least a first branch (26) that extends from the probe body (16) in a direction (D) oriented toward the free puncture end (15) of the tip of the needle (13). The first branch (26) extends from the probe body (16) from a connection point (32) located at a predetermined distance (L1) from the distal end (22), thereby forming a second part (28) of the probe body (16) between the connection point (32) of the first branch (26) and the distal end (22) of the probe (14), wherein the probe body (16) further includes a third part (30) with less rigidity than the first branch (26) and the second part (28). The third portion (30) extends from the junction (32) of the first branch (26) toward the proximal end (20) of the probe (14). The first branch (26) and the second portion (28) are configured to pivot securely relative to the connection point (32), wherein, with the first portion (24) of the probe (14) 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 (A). During the pivoting motion about the connection point (32), the first branch (26) and the second portion (28) are fixed to each other, and the pivoting allows the first branch (26) and the second portion (28) of the probe (14) to be arranged against the right ventricular wall in the implanted state of the probe (14).
2. The component according to claim 1, characterized in that, The first branch (26) and / or the second part (28) includes at least one electrode (E1, E2).
3. The component according to claim 1, characterized in that, The probe body (16) includes at least one electrode (E3), which is spaced 2 to 50 millimeters (L3) from the connection point (32) of the probe (14). The electrode (E3) is located on the proximal side of the connection point (32) of the probe (14).
4. The component according to claim 1, characterized in that, The first branch (26) and the second part (28) each have a length between 2 and 20 millimeters.
5. The component according to claim 1, characterized in that, The probe body (16) includes a region (3) that is reinforced and elastic relative to the rest of the probe body (16), the region (3) being different from the first part (24) and corresponding to the curved region (3) of the probe (14).
6. The component according to claim 1, characterized in that, The first portion of the probe (14) further includes a support device formed by a second branch (34), the second branch extending from the probe body (16) in a direction (d) oriented toward the distal end (22) of the probe (14). The second branch (34) extends from the probe body (16) at a connection point (36) different from the second part (28) and the first branch (26).
7. The component according to claim 6, characterized in that, The connection point (36) between the second branch (34) and the probe body (16) is spaced 1 to 30 mm apart from the connection point (32) between the first branch (26) and the probe body (16).
8. The component according to claim 6, characterized in that, The probe body (16) includes at least one electrode (E4) arranged between the connection point (32) of the first branch (26) and the connection point (36) of the second branch (34).
9. The component according to any one of claims 2, 3 or 8, characterized in that, The probe (14) is a flexible microfilament comprising a conductive core coated with an electrically insulating layer, and at least one of the electrodes (E1, E2, E3, E4) is formed by a stripped region of the microfilament, and the diameter of the microfilament is not greater than 1 Fr (0.33 mm).
10. A flexible implantable stimulation probe for a component according to any one of claims 1-9, said probe (14) comprising a probe body (16), and The probe (14) can be combined with an active implantable medical device via its proximal end (20) and is configured to be implanted via its distal end (22) through the free wall of the right ventricle. The probe (14) includes a first portion (24) configured to be inserted into a needle of the assembly according to any one of claims 1-9, the first portion (24) including at least a first branch (26) that, when the first portion (24) is inserted into the needle, extends from the probe body (16) in a direction (D) oriented toward the proximal end (20) of the probe (14) and toward the free puncture end (15) of the tip of the needle. The first branch (26) extends from the probe body (16) at a predetermined distance (L1) from the distal end (22), thereby forming a second part (28) of the probe body (16) between the first branch (26) and the distal end (22) of the probe (14).
11. The flexible implantable stimulation probe according to claim 10, characterized in that, The first portion of the probe (14) further includes a support device formed by a second branch (34) extending from the probe body (16) in a direction (d) oriented toward the distal end (22) of the probe (14). The second branch (34) extends from the probe body (16) at a connection point (36) that is different from the second part (28) and different from the first branch (26).