Nerve implant systems and methods

Abstract

The present application provides a nerve implant system for percutaneous delivery of a nerve implant (1) into tissue of a patient, the nerve implant system comprising: a nerve implant (1) having a housing portion (2) and an elongated electrode lead (3); and a delivery device (10) comprising: a handle (11), a first needle (12) fixed to the handle and having a lumen adapted to receive a housing portion of a neural implant, and a second needle (13) having a higher specification number than the first needle, and a second needle comprising a retaining portion partially surrounding the elongated electrode lead and an open side extending at least partially along the length of the second needle, where the second needle is retractably mounted to the housing and retractable to deploy the electrode lead in patient tissue, where the electrode lead comprises a resiliently biased anti-migration member (32), where the anti-migration member (32) is configured to receive the second needle from the housing. And a resiliently biased anti-migration member aligned with the retaining portion of the second needle so as to be constrained prior to deployment, and wherein the resiliently biased anti-migration member is configured to move to a deployed position after retraction of the second needle.

Description

[0001] The present invention relates to a neural implant system for percutaneously delivering a neural implant into a patient's tissue, a method for percutaneously delivering a neural implant, and a medical implant. background

[0002] It is known to provide an implantable neurostimulator including a housing and electrodes. A power antenna, a microcontroller, and a communication antenna are disposed in the housing for receiving power from an external source and receiving / transmitting sensor information associated with the electrodes. The delivery system can be used to position the neurostimulator in the patient, particularly near a nerve, by cutting an opening in the patient and delivering the delivery system into the opening to position the implantable neurostimulator. Public Brief Overview

[0003] According to the present disclosure, a neural implant system for percutaneously delivering a neural implant into a patient's tissue is provided, the neural implant system comprising: A neural implant having a housing portion and an elongated electrode lead, and A conveying device, comprising: - handle, - a first needle fixed to the handle and having an inner lumen adapted to accommodate a housing part of the neural implant, - a second needle having a higher gauge than the first needle, the second needle comprising a retaining portion partially surrounding the elongated electrode lead and an open side extending at least partially along the length of the second needle, wherein the second needle is retractably mounted to the housing and is retractable to deploy the electrode lead in patient tissue, wherein the electrode lead includes a resiliently biased anti-migration member aligned with the retaining portion of the second needle so as to be constrained prior to deployment, and wherein the resiliently biased anti-migration member is configured to move to a deployed position after retraction of the second needle.

[0004] In examples, the resiliently biased anti-migration member is an elastically deformable anti-migration member.

[0005] In an example, the retaining portion of the second needle may include a wall having a recess arranged to accommodate the resiliently biased anti-migration member. In an example, the recess may be an opening extending through the wall of the retaining portion.

[0006] In an example, an electrode lead may include a plurality of resiliently biased anti-migration members.

[0007] In an example, the delivery device may include a pusher operable to push the housing portion out of the first needle.

[0008] In an example, the neural implant may include one or more resiliently biased anti-migration members disposed on the housing portion. In an example, the first needle may include a wall having a recess arranged to accommodate the resiliently biased anti-migration member.

[0009] In an example, an electrode lead may include an electrode, and a resiliently biased anti-migration member may be disposed on the electrode lead between the electrode and the housing portion.

[0010] In an example, the or each resiliently biased anti-migration member may comprise a fin. The fin may be foldable against the neural implant. The fin may be shaped to be angled towards the skin of a user when implanted.

[0011] In an example, the resiliently biased anti-migration member may include a fork. The resiliently biased anti-migration member may include a plurality of forks. In an example, a first fork of the plurality of forks may be oriented in an opposite direction to a second fork of the plurality of forks.

[0012] In an example, the resiliently biased anti-migration member may include a hook. In an example, the hook may include a shape memory material, such as a shape memory metal alloy, such as Nitinol, or a shape memory polymer. In an example, the hook may be oriented toward the housing portion.

[0013] In an example, the resiliently biased anti-migration member may include a stent. In an example, the stent may include a collapsible frame resiliently biased to an expanded position.

[0014] In an example, the resiliently biased anti-migration member may include a coil or multiple coils.

[0015] In an example, a resiliently biased anti-migration member may be disposed at or near the distal tip of the elongated electrode lead.

[0016] In an example, the resiliently biased anti-migration member may include a shape memory member embedded within the electrode lead. The shape memory member may be resiliently biased into a non-linear form. Prior to retraction of the second needle, the second needle may maintain the elongated electrode lead in a substantially linear form.

[0017] In an example, the second needle includes an opening extending longitudinally along a side of the second needle. In such an example, the resiliently biased anti-migration member may include a fork disposed on the electrode lead, and the width of the fork may be greater than the width of the opening in the second needle. In other such examples, the resiliently biased anti-migration member may include a fork disposed on the electrode lead, and the fork may be arranged to not align with the opening of the second needle.

[0018] In an example, the resiliently biased bifurcation has a first end attached to the electrode lead and a second end as a free end. The width of the resiliently biased bifurcation at the second end may be greater than the width of the resiliently biased bifurcation at the first end. In an example, the resiliently biased bifurcation is curved.

[0019] In various examples, the resiliently biased anti-migration member includes a sleeve portion surrounding a portion of the electrode lead to secure the resiliently biased anti-migration member to the electrode lead. The sleeve portion can be attached to the electrode lead, for example, by an adhesive, welding, crimping, or friction fit. In some examples, the sleeve portion can be overmolded onto the electrode lead.

[0020] In an example, the resiliently biased anti-migration member may include one or more openings formed therein for tissue ingrowth following implantation.

[0021] In an example, the second needle and the electrode lead include an anti-rotation feature. The anti-rotation feature cooperates to prevent rotation of the electrode lead within the second needle. The anti-rotation feature may extend partially or completely along the second needle and / or partially or completely along the electrode lead. Preferably, the anti-rotation member on the electrode lead is aligned with the resiliently biased anti-migration member. In an example, the anti-rotation feature includes relatively flat surfaces that abut to prevent rotation. In an example, the anti-rotation feature includes a protrusion and a slot that accommodates the protrusion to prevent rotation.

[0022] In an example, the electrode lead further comprises one or more ridged portions.

[0023] According to another aspect of the present invention, there is also provided a method for percutaneously delivering a neural implant into a patient's tissue, the method comprising: - providing the above-mentioned neural implant system, - percutaneously positioning the second needle in the patient's tissue to a desired anatomical location, - retracting the second needle to release the electrode lead into the tissue, and - deploying the anti-migration member.

[0024] According to another aspect of the present invention, a medical implant for percutaneous implantation into patient tissue via a delivery device is provided, the medical implant comprising an elastically biased anti-migration member adapted to move from a retracted position when the medical implant is accommodated in the delivery device to a deployed position when the medical implant is released from the delivery device.

[0025] In an example, the medical implant may further include a housing portion and an elongated electrode lead extending from the housing portion. In an example, a resiliently biased anti-migration member is disposed on the electrode lead and / or on the housing portion.

[0026] In various examples, the resiliently biased anti-migration member may include one or more of the following: - fins protruding from said medical implant, - a bifurcation protruding from said medical implant, - a hook protruding from said medical implant, - a stent protruding from said medical implant, - a coil protruding from said medical implant, and / or - A shape memory member embedded within said electrode lead.

[0027] According to another aspect of the present invention, there is also provided a delivery device for percutaneously implanting a neural implant into a patient's tissue, wherein the neural implant has a housing portion and an elongated electrode lead extending from the housing portion, and wherein the delivery device comprises: -handle, - a first needle fixed to the handle and having an inner lumen adapted to accommodate a housing part of the neural implant, a second needle having a higher gauge than the first needle, the second needle comprising a retaining portion partially surrounding the elongated electrode lead and an open side extending at least partially along the length of the second needle, wherein the second needle is retractably mounted to the housing and is retractable to deploy the electrode lead in patient tissue, and Wherein, the retaining portion includes a recess to accommodate the resiliently biased anti-migration member of the neural implant within the second needle. BRIEF DESCRIPTION OF THE DRAWINGS

[0028] Embodiments of the present invention are further described below with reference to the accompanying drawings, in which: Figure 1 A medical implant is shown; Figure 2 The location of a medical implant within a patient's body, particularly in a subcutaneous location, is shown; FIG. 3A to FIG. 3C An alternative medical implant is shown; Figure 4 shows a schematic cross-section of a delivery device including a handle in a configuration prior to implantation of a medical implant; FIG. 5A to FIG. 5C The operation of implanting a delivery device into a medical implant is shown; Figure 6 showing a perspective view of the ends of a first needle and a second needle and a medical implant held by the first needle and the second needle; Fig. 7A The second stitch is shown; Figure 7B The first stitch is shown; Figure 8 An example implant delivery device is shown wherein the second needle is initially in a retracted position; Fig. 9 An example implant delivery device is shown wherein the tab is moved toward the handle to retract the second needle; Figures 10 to 31 Various example anti-migration members of medical implants are shown; Fig.32 and Fig.33 Examples of needles and medical implants having anti-rotation features are shown; and Fig.34 and Fig.35 An example electrode lead of a medical implant including a ridged portion is shown. Detailed Description

[0029] Figure 1 A medical implant 1 is schematically shown. In an example, the medical implant 1 can be a neural implant, such as a neurostimulator implant or a diagnostic implant. The medical implant 1 includes a housing portion 2 and an elongated electrode lead 3. The housing portion 2 can house electronic components of the medical implant 1, including, for example, a printed circuit board, a wireless communication receiver / transmitter, a wireless power receiver and / or sensor electronics, as further described below. In an example, the housing portion is hermetically sealed. The housing portion 2 can include a cylindrical housing with sealed ends, or can include a wrap or other enclosure of components within the housing portion 2.

[0030] In examples, the electrode lead 3 extends from the housing portion 2 and is flexible. The electrode lead 3 includes at least one electrode 4, and in some examples, a plurality of electrodes 4 spaced along the length of the electrode lead 3. The electrode 4 is connected to electronics within the housing portion 2.

[0031] In an example, the housing portion 2 can have a diameter between about 0.5 mm and about 5 mm, such as a diameter between about 1 mm and about 3 mm. The housing portion 2 can have a length of up to about 10 mm, such as a length of up to about 5 mm. In an example, the electrode lead 3 can have a diameter between about 0.3 mm and about 1.5 mm, such as a diameter between about 0.5 mm and 1.3 mm. The electrode lead 3 can have a length of up to about 100 mm, such as a length of up to about 50 mm, such as a length of about 50 mm. However, it will be appreciated that the size of the housing portion 2 will correspond to the size of the electronic device housed in the housing portion 2, and the length of the electrode lead 3 will correspond to the anatomical structure surrounding the target nerve, so a shorter or longer electrode lead 3 may be appropriate depending on the depth of the nerve within the muscle tissue.

[0032] As further described below, the medical implant 1 is implantable in a patient and operable to sense and / or stimulate nerves. In some examples, the medical implant 1 is implantable to sense and / or stimulate the greater occipital nerve, but the same or similar implants may be implantable to sense and / or stimulate other nerves, particularly other peripheral nerves of the peripheral nervous system. In examples, the medical implant 1 may be implantable to sense and / or stimulate the tibial nerve, the sacral nerve (e.g., for treating urinary incontinence), or the vagus nerve (e.g., for regulating pancreatic secretions).

[0033] Figure 2 The medical implant 1 is shown when implanted in a patient. The medical implant 1 is positioned below the skin surface, in particular below the epidermis 5. The housing portion 2 may be positioned in the dermis 6 or in the subcutaneous tissue 7. Positioning the housing portion 2 in the subcutaneous tissue 7 may be advantageous in causing less damage and / or irritation to the patient.

[0034] As shown, the electrode lead 3 extends from the housing portion 2, passes through the underlying tissue (particularly muscle 8), and reaches a position close to the target nerve 9. The electrode lead 3 is positioned so that the electrode (4, see Figure 1 ) is in contact with or close to nerve 9, and thus electrode 4 can be used to sense and / or stimulate nerve 9.

[0035] The medical implant 1 may further comprise one or more anti-migration members. The anti-migration members may be provided on the housing portion 2 and / or on the electrode lead 3 and are used to maintain the medical implant 1 in place in the patient's tissue.

[0036] In the example, the medical implant 2 is battery-free and does not have an integrated power source. The external device 52 can wirelessly power the medical implant 1. The external device 52 can also wirelessly communicate with the medical implant 1, in particular the electronic devices in the housing portion 2. The medical implant 1 can include a wireless communication receiver / transmitter for communicating with the external device 52. The medical implant 1 can also have a processor or controller configured to operate the medical implant 1. The external device 52 can be positioned on the skin near the medical implant 1. The external device 52 can be adhered to the skin near the medical implant 1. The external device 52 can be a wearable device.

[0037] In an example, the medical implant 1 is a neural implant. The medical implant 1 may be implanted to target a specific nerve or group of nerves, such as the greater occipital nerve.

[0038] In operation, the electrodes 4 of the neurostimulator implant are provided with an electrical signal, such as an electric current, to stimulate the nerve. In an example, the electrical signal may be a voltage-regulated stimulation. Such stimulation may provide relief from chronic pain (e.g., occipital neuralgia, intractable migraine) and / or other therapeutic benefits.

[0039] In other examples, the medical implant 1 can be a diagnostic implant, such as a neurodiagnostic implant, which is operable to detect one or more neural signals in a nerve. In such an example, the electrode 4 is operable to detect the neural signal. The neural signal can be analyzed for the purpose of detecting, monitoring and / or diagnosing a condition.

[0040] In other examples, the diagnostic implant may additionally or alternatively detect one or more patient vital signs, such as temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentrations (e.g., oxygen, carbon dioxide, carbon monoxide).

[0041] FIG. 3A to FIG. 3C An alternative example of a medical implant 1 is shown.

[0042] exist Figure 3A In the example of FIG. 1 , the medical implant 1 includes a housing portion 2 and an electrode lead 3, wherein the electrode lead 3 is formed with an electrode 4. The housing portion 2 includes a shell 2a. The shell 2a may be cylindrical and houses electronic components therein. The housing portion 2 includes a wireless power receiver 35 for receiving power from an external device (52, see FIG. 5 ) when implanted in a patient. Figure 2 ) receives wireless power.

[0043] exist Figure 3B In the example of FIG. 4 , the medical implant 1 does not include the electrode lead 3 , and the electrode 4 is formed on the housing part 2 . Figure 3B An example of a device may be a neural implant, such as a neurostimulator implant or a diagnostic implant that is implantable near a nerve in the same manner as described above. In this example, the housing 2a of the housing portion 2 includes electrodes 4 separated by an insulating region 34. In some examples, as shown, the housing portion 2 also holds a wireless power receiver 35. The wireless power receiver 35 is disposed in the housing portion 2 and may be spaced apart from the electrode 4.

[0044] exist Figure 3CIn examples of, the medical implant 1 is used in conjunction with another medical implant 73. The other medical implant 73 may be a deep tissue implant, such as a pacemaker. In these examples, the medical implant 1 may act as a wireless power receiver or wireless power relay for the other medical implant 73. The medical implant includes a wireless power receiver 35 and a wireless power transmitter 75, and is arranged to relay power to a wireless power receiver 76 of the other medical implant 73. The wireless power transmitter 75 of the medical implant 1 may be connected to the housing portion 2 via a wire 77, as shown, or it may be within the housing portion 2 and the wire 77 may be omitted. The medical implant 1 may be implanted at a lower depth in the tissue than the other medical implant 73, thereby providing improved wireless power coupling.

[0045] Figure 4 An example delivery device 10 for implanting a medical implant 1 into a patient's tissue is shown. In particular, the delivery device 10 is used to implant the medical implant 1 percutaneously into a Figure 2 The conveying device 10 has a position as shown. Figure 3A 2 and electrode leads 3 shown in the example medical implant 1 (particularly a neurostimulator implant). However, it will be appreciated that the delivery device 10 may be adapted for implantation in a reference FIG. 3A to FIG. 3C Other medical implants described 1.

[0046] exist Figure 4 In the example of the delivery device 10, the delivery sheath includes a first portion and a second portion, specifically a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 are parallel and both extend in the longitudinal direction. The second needle 13 extends further than the first needle 12. In particular, the first needle 12 has a top 14, such as a beveled top, and the second needle 13 extends beyond the top 14 of the first needle 12. The second needle 13 also has a top 15, in particular a beveled top. The second needle 13 has a higher gauge than the first needle 12 (i.e., the second needle 13 has a smaller diameter than the first needle 12).

[0047] During use, the housing portion 2 of the medical implant 1 is received in the first needle 12, in particular in the lumen of the first needle 12. During use, the electrode lead 3 is received in the second needle 13, in particular in the lumen of the second needle 13. As shown, the electrode lead 3 extends along a majority of the second needle 13 toward the tip 15. A portion of the electrode lead 3 adjacent to the housing portion 2 extends through an opening in the second needle 13, as shown in FIG. Figure 6 Thus, during use, the medical implant 1 is positioned within the first needle 12 and the second needle 13 of the delivery device 10 .

[0048] As shown, the first needle 12 and the second needle 13 are axially offset. In particular, the center axis of the first needle 12 is offset from the center axis of the second needle 13. In the example shown, the second needle 13 extends into the first needle 12 (in particular, into the inner cavity of the first needle 12), so that the second needle 13 is partially received in the first needle 12, side by side with the housing part 2.

[0049] refer to Figure 6 , the second needle 13 includes an opening 18 or a slot to allow a portion of the electrode lead 3 to extend out of the second needle 13 and connect to the housing portion 2. The opening 18 may extend to the top end 15 of the second needle 13. The opening 18 may extend along most of the second needle 13 or all of the second needle 13.

[0050] Reference again Figure 4 During use, the first needle 12 percutaneously penetrates the patient's tissue to position the housing portion 2 at a first depth, and the second needle 13 percutaneously penetrates the patient's tissue to position the electrode lead 3 at a second depth. Once the electrode lead 3 is correctly positioned, the delivery device 10 releases and deploys the medical implant 1 to leave the medical implant 1 in the patient's body. Figure 2 The tip 14 of the first needle 12 and the tip 15 of the second needle 13 are sharp tips respectively adapted to pierce the patient's skin and penetrate tissue to position the first needle 12 and the second needle 13 percutaneously at an appropriate depth. As known to those skilled in the art, the tips 14, 15 may be bevel tips. In some examples, during use, the first needle 12 and the second needle 13 are used to pierce the patient's skin and underlying tissue, and in some examples an incision is first formed and the first needle 12 and the second needle 13 are inserted into the patient's tissue through the incision.

[0051] In an example, the first needle 12 may have a gauge number between 6 and 15, such as 10. In an example, the second needle 13 may have a gauge number between 15 and 25, such as 20.

[0052] In various examples, the second needle 13 can be retracted relative to the first needle 12 to deploy the electrode lead 3. When the second needle 13 is retracted, the opening 18 (see FIG. 1 ) of the second needle 13 is Figure 6 ) allows deployment of electrode lead 3.

[0053] In an example, the housing portion 2 is releasably attached to the first needle 12 (or another portion of the delivery device 10 ) and is released prior to deployment.

[0054] In an example, the housing portion 2 may be deployed from the first needle 12 simply by pulling the implant delivery device away from the patient and relying on friction between the electrode lead 3 and the patient's tissue to hold the medical implant in place and pulling the housing portion 2 from the first needle 12. In other examples, the delivery device 10 may include a deployment member, such as a pusher, adapted to push the housing portion 2 out of the first needle 12 to deploy the housing portion 2 at the appropriate anatomical site. In some examples, the implant delivery device may include a retaining member that is arranged to retain the housing portion 2 in the first needle 12 prior to deployment and may be operable to release the housing portion 2 before the delivery device 10 is removed.

[0055] FIG. 5A to FIG. 5C Shows Figure 4 Operation of the conveying device 10.

[0056] As shown in the figure, the exemplary delivery device 10 further includes a handle 11. The handle 11 is suitable for being held by an operator. A first needle 12 is fixed to the handle 11.

[0057] The second needle 13 extends through the first needle 12 and through the handle 11. An actuation tab 16 is provided on the end of the second needle 13 opposite to the tip 15. In particular, the actuation tab 16 may be a gripping handle or the like for an operator to grip.

[0058] The second needle 13 can be retracted relative to the first needle 12. In particular, the second needle 13 can pass through the first needle 12 and the handle 11 from Figure 5A Slide to the position shown Figure 5B In this example, the second needle 13 can be retracted by pulling the actuation tab 16 in a direction away from the patient. Retracting the second needle 13 in this manner deploys the electrode lead 3. Figure 6 ) is provided for the portion of the electrode lead 3 connected to the housing portion 2. The opening 18 extends to the tip 15 of the second needle 13.

[0059] A locking device 17 is provided to lock the second needle 13 to the handle 11 and / or the first needle 12. As shown, the locking device 17 can be arranged at or near the actuation tab 16 and in the example locks the actuation tab 16 and / or the second needle 13 to the handle 11. The locking device 17 locks the second needle 13 in Figure 5B in the extended position shown in .

[0060] exist Figure 5A In the position shown, the operator can percutaneously position the implant delivery device 10 in the patient's tissue. The position of the second needle 13 is locked relative to the handle 11, so the operator can push the implant delivery device 10 into the patient's body through the handle 11.

[0061] Reference Figure 5A and Figure 2 , when the implant delivery device 10 is pushed into the patient's body, the second needle 13 first penetrates the skin 5, and when the implant delivery device 10 is further pushed, the first needle 12 then penetrates the skin 5. The first needle 12 and the second needle 13 are thereby positioned at an appropriate depth in the patient's body, and the housing portion 2 and the electrode lead 3 are also positioned at an appropriate depth at the same time. Therefore, the implant delivery device 10 provides percutaneous delivery of the medical implant 1 into the patient's tissue.

[0062] In an example, the operator may use an ultrasound imaging device to monitor the position of the second needle 13 (and the first needle 12 ) to guide the second needle 13 toward the target nerve 9 .

[0063] When the implant delivery device 10 is in a proper position with the tip 15 of the second needle 13 (and the electrode lead 3 within the second needle 13) positioned near the nerve and the tip 14 of the first needle 12 (and the housing portion 2 within the first needle 12) positioned in the subcutaneous tissue, the second needle 13 can be partially retracted. Figure 5A and Figure 5B In particular, the second needle 13 can be partially retracted to expose the electrode (4, see Figure 3A ). In this position, the electrode can be tested (4, see Figure 3A If necessary, the second needle 13 can be extended to Figure 6 Position as shown in A and reposition.

[0064] Once the electrode lead 3 is properly positioned, the second needle 13 is retracted Figure 5B The position shown is for deploying electrode lead 3.

[0065] The second needle 13 is retracted by unlocking the locking mechanism 17 and pulling the actuation tab 16 relative to the handle 11 to slide the second needle 13 to Figure 5B The retracted position shown. The actuation tab 16 is pulled in a direction away from the patient. During the retraction of the second needle 13, the handle 11 and the first needle 12 remain stationary. As shown, once the second needle 13 is retracted, the electrode lead 3 is deployed and exposed to the surrounding tissue (and nerves).

[0066] Next, if Figure 5C As shown, the implant delivery device 10 is withdrawn from the patient's body and the housing portion 2 is deployed from the first needle 12. In this example, the electrode lead 3 and tissue (see Figure 2The friction between the muscles 8 in the patient's body is sufficient to hold the medical implant 1 in place when the implant delivery device 10 is withdrawn, thereby deploying the housing portion 2 away from the first needle 12 when the implant delivery device 10 is withdrawn from the patient's body.

[0067] In other examples, the delivery device 10 may include a deployment member (e.g., a pusher in the first needle 12) configured to push the housing portion 2 out of the first needle 12. In some examples, the implant delivery device 10 may have a retaining member arranged to releasably attach the housing portion 2 to the first needle 12 and / or the handle 11, and the retaining member may release the housing portion 2 after the second needle 13 is retracted and before the first needle 12 is removed from the patient.

[0068] Figure 6 , Fig. 7A and Figure 7B The first needle 12 and the second needle 13 of the above-mentioned delivery device 10 are shown. As shown, the electrode lead 3 is received in the second needle 13, and the second needle 13 includes a slot 18, which allows the electrode lead 3 to be connected to the housing portion 2 in the first needle 12. The slot 18 extends partially along the second needle 13 from the top 15 and can extend most of the length of the second needle 13 or the entire length of the second needle 13. The second needle 13 can be in the form of a sheath. The first needle 12 receives the housing portion 2.

[0069] The first needle 12 includes a beveled tip 14. The second needle 13 includes a beveled tip 15. The beveled tips 14, 15 are sharp for piercing the patient's skin and penetrating tissue during use.

[0070] like Figure 6 As shown, the second needle 13 extends through the inner cavity of the first needle 12. In particular, as Figure 7B As shown, the first needle 12 includes a main portion 19A and a secondary portion 19B. The main portion 19A and the secondary portion 19B are merged so that the first needle 12 has a single lumen. The main portion 19A and the secondary portion 19B are shaped to define two distinct portions 19A and 19B.

[0071] The main portion 19A is shaped to accommodate the housing portion 2. In particular, the main portion 19A is sized to accommodate the housing portion 2 and has a substantially circular cross-section that maintains the housing portion 2 in axial alignment within the main portion 19A.

[0072] The secondary portion 19B is shaped to accommodate the second needle 13. In particular, the secondary portion 19B is sized to accommodate the second needle 13 and has a substantially circular cross-section that maintains the second needle 13 in axial alignment within the secondary portion 19B.

[0073] In the example, the secondary part 19B and the main part 19A each have a substantially circular cross section, and the cross sections at least partially overlap. In such an example, the housing part may be pushed to one side of the main part 19A due to the presence of the second needle 13 in the secondary part 19B.

[0074] The slot 18 in the second needle 13 is oriented toward the center of the first needle 12, thereby allowing the electrode lead 3 to be connected to the housing portion 2, such as Figure 6 shown.

[0075] Thus, the first needle 12 is shaped to accommodate the housing part 2 and the second needle 13 and allow the second needle 13 to slide towards the retracted position. The positioning of the second needle 13 within the cavity of the first needle 12 advantageously means that only one puncture wound is formed in the patient's skin, because during use the first needle 12 will enlarge the puncture wound formed by the second needle 13.

[0076] In an alternative example, the second needle 13 does not enter or pass through the lumen of the first needle 12. Instead, the second needle 13 can extend through another portion of the handle 11, such as adjacent to the first needle 12.

[0077] In the above example, the second needle 13 is initially in the extended position, and the first needle 12 and the second needle 13 may be positioned in the patient's body at the same time. Figure 8 An alternative example is shown in which the second needle 13 is initially in a retracted position. In this example, as shown, the actuation tab 4 extends from the handle 11. In the retracted position, the second needle 13 can be within the first needle 12, as shown, or side by side with the first needle 12 within the handle 11. The electrode lead 3 is partially located within the second needle 13 and is looped between the housing portion 2 and the second needle 13.

[0078] During implantation, the first needle 12 is inserted into the patient's body, wherein the implant delivery device 10 is in Figure 8 In the illustrated configuration, the actuation tab 16 is then pushed toward the handle 11 to extend the second needle 13 beyond the first needle 12 and bring the electrode lead 3 into position. In this position, the locking mechanism 17 can be engaged so that the actuation tab 16 and the second needle 13 are locked in place.

[0079] In some examples, the implant delivery device 10 can be removed from the patient with the second needle 13 in the extended position, and a deployment member (e.g., a pusher) can be provided to push the medical implant 1 out of the first needle 12 and the second needle 13. In other examples, after being extended, the second needle 13 can then be deployed as described above. FIG. 5A to FIG. 5C The described manner pulls the actuation tab 16 away from the handle 11 to be retracted to release the electrode lead 3 and the housing portion 2 .

[0080] Fig. 9An alternative example delivery device 10 is shown. In this example, as previously described, the delivery device 10 includes a handle 11, a first needle 12 holding a housing portion 2, and a second needle 13 holding an electrode lead 3. In this example, an actuation tab 16 is arranged to be pushed toward the handle 11 (and the patient) in order to retract the second needle 13.

[0081] Specifically, as shown, the implant delivery device 10 has a rack and pinion mechanism for converting movement of the actuation tab 16 toward the handle 11 into retraction of the second needle 13 (ie, the second needle 13 moves in a direction opposite to the actuation tab 16 ).

[0082] like Fig. 9 As shown, the rack and pinion transmission mechanism includes a first rack portion 30A, which is attached to the second needle 13 or forms a part of the second needle 13. The rack and pinion transmission mechanism also includes a second rack portion 30B, which is attached to the actuation tab 16 or forms a part of the actuation tab 16. The gear 31 is rotatably mounted in the handle 11 and meshes with both the first rack portion 30A and the second rack portion 30B. The gear 31 can be mounted in the first needle 12, or, as shown, behind the end of the first needle 12 in the handle 11. Therefore, when the actuation tab 16 is pushed toward the patient, the rack and pinion transmission mechanism retracts the second needle 13 away from the patient to release the electrode lead 3.

[0083] Advantageously, pushing the actuation tab 16 rather than pulling the actuation tab 16 may allow for single-handed operation of the implant delivery device 10 .

[0084] It will be appreciated that in some examples, the delivery device 10 described above may be adapted for implantation. Figure 3B In these examples, the second needle 13 can be omitted so that the delivery sheath only includes the first needle 12 that holds the medical implant 1. In such examples, implantation is achieved by percutaneously positioning the first needle 12 and then expelling (e.g., pushing out) the medical implant 1 from the first needle 12.

[0085] It will be appreciated that in some examples, the delivery device 10 described above may be adapted for implantation. Figure 3C In these examples, the second needle 13 can hold the wire 77 and the wireless power transmitter 75, and the first needle 12 can hold the housing portion 2. As described above, the second needle 13 can be retractable to implant the wire 77 and the wireless power transmitter 75.

[0086] The medical implant 1 comprises one or more anti-migration members 32 adapted to be attached to the medical implant 1 when the medical implant 1 is delivered to the Figure 2 Keep it in place while it is in the position shown. Figures 10 to 23 Various example anti-migration members 32 are shown. Figures 10 to 23 Reference Figure 3A The medical implant 1 of FIG. 1 shows different anti-migration members 32, which includes a housing portion 2 and an elongated electrode lead 3 having an electrode 4. Each of the anti-migration members 32 can be disposed on the electrode lead 3 and / or on the housing portion 2. However, it will be appreciated that the anti-migration members 32 described below can be disposed on the reference Figure 3B In the medical implant 1 described above, in this case, the anti-migration member 32 is arranged on the housing part 2. In addition, the anti-migration member 32 described below can be arranged on the housing part 2. Figure 3C On the described medical implant 1 , in this case the anti-migration member 32 may be arranged on the housing part 2 and / or on the lead 77 and / or on the wireless power transmitter 75 .

[0087] exist Figure 10 to Figure 2 2, the anti-migration member 32 is resiliently biased and received within the delivery sheath prior to deployment of the medical implant 1. When the medical implant 1 is released from the delivery device 10, the resiliently biased anti-migration member 32 moves to a deployed position where it is used to maintain the medical implant 1 in place within the patient's tissue.

[0088] exist Fig.10 In the example of the invention, the medical implant 3, in particular the electrode lead 3, comprises one or more (three in this example) anti-migration members 32. In this example, the anti-migration member 32 is a resiliently biased fin 33 protruding from one side of the electrode lead 3. The fin 33 is angled toward the distal tip 35 of the electrode lead 3. The fin 33 is made of an elastically deformable material, such as metal (stainless steel), aluminum or nitinol, or a biocompatible polymer. The fin 33 may be a thin sheet-like protrusion. The fin 33 may be integrated into the electrode lead 3, in particular the housing or the electrode lead 3, or may be attached by a collar or a clamp.

[0089] The angled shape of the fins 33 provides for deformation of the fins 33 towards the electrode lead 3 as the electrode lead 3 moves into the patient's tissue and when the electrode lead 3 is received in a delivery sheath of a delivery device. The fins 33 also serve to prevent the electrode lead 3 from being pulled out of the patient.

[0090] In an example, the fins 33 may be folded against one side of the electrode lead 3 within the delivery sheath. In this way, when the electrode lead 3 is moved out of the delivery sheath (e.g., when the second needle 13 is retracted), the fins 33 (due to their elasticity) are unfolded to Fig.10 Position shown.

[0091] In other examples, the fins 33 can be housed in recesses or openings 34 formed in a delivery sheath (e.g., second needle 13, as shown). The recesses 34 can receive the fins 33, and the fins 33 can deform as they move out of the recesses 34 during retraction of the second needle 13. Similarly, the openings 34 can receive the fins 33 so that the fins 33 protrude through the second needle 13, and the fins 33 can deform as they move out of the openings 34 during implantation.

[0092] In some examples, the fins 33 may be provided additionally or alternatively on the housing portion 2 of the medical implant. In some examples, the fins 33 may be provided Figure 3B In some examples, the fins 33 may be disposed on the housing portion of the medical implant 1. Figure 3C On the housing part 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0093] exist Fig.11 In the example of , the medical implant 3 (particularly the electrode lead 3) includes one or more (three in this example) anti-migration members 32. In this example, the anti-migration member 32 is a resiliently biased fork 36 protruding from one side of the electrode lead 3. In this example, the forks 36 are arranged in pairs, positioned on opposite sides of the electrode lead 3. The forks 36 are attached to the electrode lead 3 at one end and protrude longitudinally along the electrode lead 3 away from the distal tip 35 of the electrode lead 3. The forks 36 are made of an elastically deformable material, such as metal (stainless steel), aluminum or nitinol, or a biocompatible polymer. The forks 36 are thin sheet-like protrusions. The forks 36 are resiliently biased to Fig.11 The position shown is one in which the fork 36 projects from the electrode lead 3 at an angle.

[0094] The forks 36 may be integrated into the electrode lead 3, in particular into the housing or the electrode lead 3. In other examples, the forks 36 may extend from a collar attached to the electrode lead 3, or they may be clamped to the electrode lead 3.

[0095] As the electrode lead 3 is moved into the patient's tissue, the orientation of the forks 36 provides for deformation of the forks 36 towards the electrode lead 3. The forks 36 also serve to prevent the electrode lead 3 from being pulled out of the patient.

[0096] In an example, the forks 36 can be folded against the sides of the electrode lead 3 within the delivery sheath (e.g., second needle 13) prior to deployment. In this way, the forks 36 move outward (due to their elasticity) during implantation. Fig.11 Position shown.

[0097] In an example, the fork 36 may be connected to the reference Fig.10The fins 33 are similarly described as being received in recesses or openings formed in a delivery sheath (eg, second needle).

[0098] In some examples, the fork 36 may be provided additionally or alternatively on the housing portion 2 of the medical implant. Figure 3B In some examples, the fork 36 may be disposed on the housing portion of the medical implant 1. Figure 3C On the housing part 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0099] Fig.12 An example similar to Fig.11 An example in which the forks 36 are arranged on the electrode lead 3, the housing portion 2, the wire 77 or the wireless power transmitter 75 of the medical implant 1. In this example, the second set of forks 37 are arranged in an orientation opposite to the forks 36 to prevent the movement of the medical implant 1 in two directions.

[0100] exist Fig.13 In the example of the invention, the medical implant 1, in particular the electrode lead 3, includes an anti-migration member 32. In this example, the anti-migration member 32 is a resiliently biased hook 38 protruding from one side of the electrode lead 3. The hook 38 is attached to the electrode lead 3 at one end and initially protrudes toward the distal tip 35 and then in a substantially opposite direction, thereby forming a hook. The hook 38 is made of an elastically deformable material, preferably a shape memory material, such as spring stainless steel or nitinol. The hook 38 is resiliently biased to Fig.13 The position shown is one in which the hook 38 protrudes from the electrode lead 3 at a certain angle.

[0101] The hook 38 may be integrated into the electrode lead 3, in particular into the housing or the electrode lead 3. In other examples, the hook 38 may extend from a collar attached to the electrode lead 3, or may be clamped to the electrode lead 3.

[0102] As the electrode lead 3 moves into the patient's tissue, the orientation of the hook 38 provides for deformation of the hook 38 toward the electrode lead 3. When deforming inward, the hook 38 lies flat on one side of the electrode lead 3. Fig.13 When deployed as shown, the hook 38 serves to prevent the electrode lead 3 from being pulled out of the patient.

[0103] In an example, the hook 38 can be folded against the side of the electrode lead 3 within the delivery sheath (e.g., second needle 13 as shown) prior to deployment. In this way, the hook 38 moves outward (due to its elasticity) during implantation. Fig.13 Position shown.

[0104] In an example, the hook 38 may be received in a recess or opening 39 formed in the delivery sheath (eg, within the second needle 13).

[0105] In some examples, the hook 38 may be additionally or alternatively disposed on the housing portion 2 of the medical implant. In some examples, the hook 38 may be disposed on the housing portion 2 of the medical implant. Figure 3B In some examples, the hook 38 may be disposed on the housing portion of the medical implant 1. Figure 3C On the housing part 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0106] Fig.14 An example similar to Fig.13 , but the hook 40 is disposed at the distal tip 35 of the electrode lead 3. The hook 40 may be folded against the side of the electrode lead 3 within the delivery sheath (e.g., the second needle 13), and / or it may be accommodated in a recess or opening 41 formed in the delivery sheath (e.g., the second needle 13).

[0107] Fig.15 An example similar to Fig.13 , wherein the anti-migration member 32 comprises a resiliently biased hook 44 attached to the electrode lead 3. In this example, the anti-migration member 32 comprises two resiliently biased hooks 44 attached to the electrode lead 3 via a collar 45. As shown, the anti-migration member 32 is received in a recess or opening 46 formed in a delivery sheath (e.g., the second needle 13).

[0108] In some examples, the elastically biased hook 44 may be additionally or alternatively disposed on the housing portion 2 of the medical implant 1. In some examples, the elastically biased hook 44 may be disposed on the housing portion 2 of the medical implant 1. Figure 3B In some examples, the elastically biased hook 44 may be disposed on the housing portion of the medical implant 1. Figure 3C On the housing part 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0109] exist Fig.16 In the example of the invention, the medical implant 1, in particular the electrode lead 3, includes an anti-migration member 32. In this example, the anti-migration member 32 is a resiliently biased fork 42 formed by the outer layer of the electrode lead 3. In particular, the electrode lead 3 includes an outer layer, and the resiliently biased fork 42 is formed by a U-shaped cutout in the outer layer, which allows the fork 42 to elastically deform outward. As shown in the figure, when the resiliently biased fork 42 is deployed, a recess 43 is left in the outer layer of the electrode lead 3. Therefore, when the electrode lead 3 is accommodated in the delivery sheath (e.g., the second needle 13, see Figure 4), the resiliently biased forks 42 are held in the recess 43. In the example shown, there are a plurality of resiliently biased forks 42, in particular four resiliently biased forks 42. The resiliently biased forks 42 are spaced along the length of the electrode lead 3 and may additionally or alternatively be spaced radially around the electrode 3. Thus, the resiliently biased forks 42 move outwardly and serve to prevent movement of the electrode lead 3 during implantation.

[0110] In examples, the outer layer of the electrode lead 3 (and the resiliently biased prongs 42 ) may be made of a metal such as steel or of a biocompatible polymer.

[0111] In some examples, the elastically biased fork 42 may be additionally or alternatively disposed on the housing portion 2 of the medical implant 1. In some examples, the elastically biased fork 42 may be disposed on the housing portion 2 of the medical implant 1. Figure 3B In some examples, the elastically biased fork 42 may be disposed on a housing portion of the medical implant 1. Figure 3C On the housing part 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0112] exist Fig.17A and Fig. 17B In the example of , the medical implant 1 comprises one or more anti-migration members 32. In this example, the anti-migration member 32 comprises a plurality of resiliently biased hooks 44 formed at one end of the electrode lead 3 and / or at an end of the housing portion 2 opposite to the electrode lead 3. Fig.17A and Fig. 17B Two options are shown. As shown, a plurality of resiliently biased hooks 44 are formed at one end of the medical implant 1 and have different orientations to be radially spaced relative to the medical implant 1. The plurality of resiliently biased hooks 44 are resilient and biased toward a bent position, such as Fig.17A , where they are used to anchor a medical implant 1 in the tissue of a patient.

[0113] like Fig. 17B As shown, before deployment, a plurality of elastically biased hooks 44 are arranged in a deflected state (ie, straight) within the delivery sheath (eg, second needle 13). When the medical implant 1 is deployed, the plurality of elastically biased hooks 44 return to their biased positions, also as shown in FIG. Fig. 17B shown.

[0114] Advantageously, positioning the anti-migration member 32 at one end of the medical implant 1 can avoid any increase in the diameter of the medical implant 1 and the accompanying delivery device. In addition, providing the anti-migration member 32 on both the electrode lead 3 and the housing portion 2 can improve anchorage when both ends of the medical implant 1 are anchored.

[0115] In some examples, the anti-migration member 32 may be disposed in Figure 3B The anti-migration member 32 may be disposed on the housing portion 2 of the medical implant 1, for example, on both ends of the housing portion 2. In some examples, the anti-migration member 32 may be disposed on the housing portion 2 of the medical implant 1. Figure 3C On one or more of the housing portion 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0116] exist Fig.18 In the example of the invention, the medical implant 1, in particular the electrode lead 3, comprises an anti-migration member 32. In this example, the anti-migration member 32 is a resiliently biased frame 45 having a collapsed configuration and an expanded configuration, in which the resiliently biased frame 45 can be placed in a delivery sheath (e.g., a second needle 13, see Figure 4 ), the expansion configuration is as follows Fig.18 As shown. The elastically biased frame 45 is biased toward the expanded configuration. The elastically biased frame 45 can be made of a polymer or a metal, and is preferably made of a memory material such as Nitinol.

[0117] Thus, when the medical implant 1 is deployed, the elastically biased frame 45 will expand into the expanded configuration and anchor the medical implant 1. As shown, the elastically biased frame 45 is disposed on the electrode lead 3 and may be attached to the electrode lead 3 by a collar, a clamp, or the like. The elastically biased frame 45 is positioned between the housing portion 2 and the electrode 4 so that when the elastically biased frame 45 is not deployed, the delivery sheath (e.g., the second needle 13, see Figure 4 ) can be partially retracted to expose the electrode 4. Therefore, the position of the electrode 4 can be tested before deploying the anti-migration member 32. In an alternative example, the anti-migration member 32 is provided on the housing portion 2 in addition to or in conjunction with being provided on the electrode lead 3.

[0118] In some examples, the anti-migration member 32 may be disposed in Figure 3B In some examples, the anti-migration member 32 may be disposed on the housing portion 2 of the medical implant 1. Figure 3C On one or more of the housing portion 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0119] exist Fig.19 In the example of the invention, the medical implant 1, in particular the electrode lead 3, comprises an anti-migration member 32. In this example, the anti-migration member 32 is a resiliently biased stent 46 having a collapsed configuration and an expanded configuration, in which the resiliently biased stent 46 can be placed in a delivery sheath (e.g., a second needle 13, see Figure 4 ), the expansion configuration is as follows Fig.19As shown. The elastically biased stent 46 is biased toward the expanded configuration. The elastically biased stent 46 may include one or more struts and / or rings in a conventional manner, such as a vascular stent. The elastically biased stent 46 may be made of a biocompatible polymer or metal, and is preferably made of a memory material such as nitinol.

[0120] Thus, when the medical implant 1 is deployed, the elastically biased stent 46 will expand into the expanded configuration and anchor the medical implant 1. As shown, the elastically biased stent 46 is disposed on the electrode lead 3 and may be attached to the electrode lead 3 by a collar or the like. The elastically biased stent 46 is positioned between the housing portion 2 and the electrode 4 so that when the elastically biased stent 46 is not deployed, the delivery sheath (e.g., the second needle 13, see Figure 4 ) can be partially retracted to expose the electrode 4. Therefore, the position of the electrode 4 can be tested before deploying the anti-migration member 32. In an alternative example, the anti-migration member 32 is provided on the housing portion 2 in addition to or in conjunction with being provided on the electrode lead 3.

[0121] In some examples, the anti-migration member 32 may be disposed in Figure 3B In some examples, the anti-migration member 32 may be disposed on the housing portion 2 of the medical implant 1. Figure 3C On one or more of the housing portion 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0122] exist Fig. 20 In the example of the invention, the medical implant 1, in particular the electrode lead 3, comprises an anti-migration member 32. In this example, the anti-migration member 32 is a resiliently biased coil 47 having a collapsed configuration and an expanded configuration, in which the resiliently biased coil 47 can be placed in a delivery sheath (e.g., a second needle 13, see Figure 4 ), the expansion configuration is as follows Fig. 20 As shown. The elastically biased coil 47 is biased toward the expanded configuration. The elastically biased coil 47 may be made of a biocompatible polymer or metal, and is preferably made of a memory material such as Nitinol.

[0123] Thus, when the medical implant 1 is deployed, the resiliently biased coil 47 will expand into the expanded configuration and anchor the medical implant 1. As shown, the resiliently biased coil 47 is disposed on the electrode lead 3 and may be attached to the electrode lead 3 by a collar, clamp or the like.

[0124] In the example shown, the spring-biased coil 47 is located at one end of the electrode lead 3. In other examples, the spring-biased coil 47 can be positioned between the housing portion 2 and the electrode 4 so that the delivery sheath (e.g., the second needle 13, see FIG. 1 ) is not deployed. Figure 4 ) can be partially retracted to expose the electrode 4. Therefore, the position of the electrode 4 can be tested before deploying the anti-migration member 32. In an alternative example, the anti-migration member 32 is provided on the housing portion 2 in addition to or in conjunction with being provided on the electrode lead 3.

[0125] In some examples, the anti-migration member 32 may be disposed in Figure 3B The anti-migration member 32 may be disposed on the housing portion 2 of the medical implant 1, for example, on both ends of the housing portion 2. In some examples, the anti-migration member 32 may be disposed on the housing portion 2 of the medical implant 1. Figure 3C On one or more of the housing portion 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0126] Fig.21 An example similar to Fig. 20 , wherein the anti-migration member 32 comprises a resiliently biased coil 47. However, in Fig.21 In the example of , the anti-migration member 32 further comprises a second elastically biased coil 48 attached to the elastically biased coil 47. The second elastically biased coil 48 is formed in the same manner as the elastically biased coil 47 described above and is connected by a straight portion. The second elastically biased coil 48 improves the anchoring of the medical implant 1.

[0127] In the example of FIG. 22 , the medical implant 1, in particular the electrode lead 3, includes an anti-migration member 32. In this example, the anti-migration member 32 is a shape memory member 49 extending through the electrode lead 3. Specifically, as shown in FIG. Fig. 22B As shown, a shape memory member 49 is embedded in the electrode lead 3. The shape memory member 49 can be disposed next to or between a conductor (wire) 50 in the electrode lead 3. The shape memory member 49 can extend the entire length of the electrode lead 3, or extend partially along the electrode lead 3, or include multiple portions spaced apart along the electrode lead 3. The shape memory member 49 can be a polymer or a metal, in particular a shape memory material such as Nitinol. The shape memory member 49 has a nonlinear form, such as a wavy shape as shown. Thus, when unconstrained, the electrode lead 3 will adopt a nonlinear form, which is used to anchor the electrode lead 3 in the patient's tissue. When the electrode lead 3 is constrained in a delivery sheath (e.g., a second needle 13, see Figure 4), the shape memory member 49 is deformed to be straight. Therefore, when the medical implant 1 is deployed, the shape memory member 49 will deform the electrode lead 3 into a nonlinear form and anchor the medical implant 1. The shape memory member 47 also allows the delivery sheath (e.g., the second needle 13, see Figure 4 ) is partially retracted to expose the electrode 4. The delivery sheath (eg, second needle 13, see Figure 4 ) can also be re-extended for repositioning the electrode lead 3. Thus, the position of the electrode 4 can be tested before the electrode lead 3 is fully deployed.

[0128] In some examples, the shape memory member 47 may be disposed in Figure 3C The guide wire 77 of the medical implant 1 .

[0129] As mentioned above, the medical implant 1 includes one or more anti-migration members 32, which are used to reduce the movement of the medical implant 1 after implantation. Figures 4 to 9 In some examples, the medical implant 1 is housed in the delivery device 10, and the electrode lead 3 includes one or more anti-migration members 32. In such an example, the anti-migration member 32 may not be aligned with the slot 18 formed in the second needle 13. In particular, the second needle 13 may have a holding portion for holding the electrode lead 3 and holding the anti-migration member 32.

[0130] exist Fig.23 In the example of , the medical implant 1, in particular the electrode lead 3, includes an anti-migration member 32. In this example, the anti-migration member 32 is a high friction area 51 formed on the surface of the electrode lead 3. The high friction area 51 may include a coating or a collar. The high friction area 51 may have a relatively high surface roughness, such as formed by grooves. Therefore, once the medical implant 1 has been implanted, the high friction area 51 can help prevent the movement of the electrode lead 3 relative to the patient's tissue. The electrode lead 3 may include more than one high friction area 51 spaced apart along the electrode lead 3, such as two as shown.

[0131] In the example shown, the high friction region 51 is located between the housing portion 2 and the electrode 4, so that the delivery sheath (eg, the second needle 13, see Figure 4 ) can be partially retracted to expose the electrode 4 without exposing the high friction area 51. Therefore, the position of the electrode 4 can be tested before the electrode lead 3 is fully deployed. In an alternative example, the anti-migration member 32 is provided on the housing portion 2 in addition to or in conjunction with being provided on the electrode lead 3.

[0132] In some examples, the high friction area 51 can be provided at Figure 3BOn the housing portion 2 of the medical implant 1. In some examples, the high friction area 51 can be arranged Figure 3C On one or more of the housing portion 2 of the medical implant 1, the wire 77 or the wireless power transmitter 75.

[0133] exist Fig.24 In the example of FIG. 1 , the medical implant 1 , in particular the electrode lead 3 , comprises an anti-migration member 32 . In this example, the anti-migration member 32 is similar to Fig.12 The invention relates to an anti-migration member of the present invention, wherein the first group of forks 36 and the second group of forks 37 are arranged on the electrode lead 4 in opposite orientations. The forks 36, 37 are elastically biased. In this example, as described above, the anti-migration member 32 is arranged so that the electrode 4 is arranged between the anti-migration member 32 and the top 35. In this example, the fork 37 has a width greater than the opening (slot) 18 in the second needle 13. Therefore, the forks 36, 37 are kept against the electrode lead 3 in the second needle 13, and cannot be deployed even if they are aligned with the opening 19. As described above, when the second needle 13 is retracted, the forks 36, 37 pop outward to anchor the electrode lead 3 in the patient's tissue. The electrode 4 is arranged between the top 35 of the electrode lead 3 and the anti-migration member 32, so that as in the above example, the second needle 13 can be partially retracted to expose the electrode 4, for example, to test the implantation position of the electrode 4, without deploying the anti-migration member 32, so that if necessary, the second needle 13 can be redeployed and the electrode lead 4 can be repositioned.

[0134] Fig.26 Shows Fig.25 FIG. 1 is an end view of an example medical implant 1. In this example, the medical implant 1, in particular the electrode lead 3, includes an anti-migration member 32. In this example, the anti-migration member 32 includes a plurality of resiliently biased forks 53 arranged on one side of the electrode lead 3. When the electrode lead 3 is held in the second needle 13, the resiliently biased forks 53 are arranged not to align with the opening 18 in the second needle 13. In particular, as shown in FIG. Fig.26As shown, the elastically biased bifurcations 53 are all arranged to extend from the electrode lead 3 within about 180 degrees of each other. When the electrode lead 3 is held in the second needle 13, none of the bifurcations 53 is aligned with the opening 18, so all the bifurcations 53 are kept against the electrode lead 3 in the retracted state. In some examples, the bifurcations 53 can be attached to the electrode lead 3 at an angle greater than or less than about 180 degrees, and in particular, the bifurcations 53 can be attached to the electrode lead 3 at an angle less than the size of the opening 18. As described above, when the second needle 13 is retracted, the bifurcations 53 pop outward to anchor the electrode lead 3 in the patient's tissue. As with the above example, the second needle 13 can be partially retracted to expose the electrode 4, for example to test the implantation position of the electrode 4, without deploying the anti-migration member 32. Therefore, if necessary, the second needle 13 can be redeployed and the electrode lead 4 can be repositioned.

[0135] exist Fig. 27 In the example of Fig.25 and Fig.26 The invention relates to an anti-migration member in which the resiliently biased forks 53 are arranged not to align with the opening 18 in the second needle 13 when the electrode lead 3 is held in the second needle 13. In this example, the forks 53 are arranged in groups 54a-54d disposed between adjacent electrodes 4.

[0136] Fig.28 An example is Fig.24 and Fig. 27 In particular, the electrode lead 3 of the medical implant 1 includes an anti-migration member formed by a first set of forks 36 and a second set of forks 37 arranged in opposite orientations on the electrode lead 4 and a group 54a-54d of forks 53 inserted between the electrodes 4.

[0137] Figure 29 to Figure 31 An example of an anti-migration member 32 is shown, which can be attached to the electrode lead 3 of the medical implant 1, such as by sliding over the electrode lead 3 and attaching to the electrode lead 3 by friction fit, adhesive or welding. In other examples, the anti-migration member 32 can be overmolded onto the electrode lead 3.

[0138] exist Fig.29 In the example of , the anti-migration member 32 includes a sleeve portion 55 that is slid over or overmolded on the electrode lead. A plurality of elastically biased forks 56 extend from the sleeve portion 55, in particular from one end of the sleeve portion 55. The forks 56 extend from one end of the sleeve portion 55. The elastically biased forks 56 have a wavy (non-linear) shape to improve anchoring.

[0139] Fig.30 An example similar to Fig.29, except that the elastically biased bifurcation 57 has an opening 58. The opening 58 can help long-term anchoring of the electrode lead 3 by allowing tissue to grow inward through the opening 58. In some examples, each elastically biased bifurcation 57 can have a single opening 58 or multiple openings 58. The opening 58 can be circular, square, rectangular, or other shapes.

[0140] In addition, Fig.30 In the example of , the elastically biased bifurcation 57 is narrower where they are attached to the sleeve portion 55 and wider at the free end. The maximum width of the elastically biased bifurcation 57 (at the free end) is greater than the width of the opening to prevent the elastically biased bifurcation 57 from being deployed before the second needle is retracted. The edge of the bifurcation 57 between the two ends can be straight, as shown, or can be non-linear, such as curved or wavy. Therefore, the width of the bifurcation 57 can change at a non-constant rate between the two ends of the bifurcation 57. The elastically biased bifurcation 57 is spaced apart from each other at the sleeve portion 55 so that there is space between the elastically biased bifurcation 57 for them to fold inward when they are accommodated in the second needle. In this example, the elastically biased bifurcation 57 is curved. The curvature can match the outer diameter of the electrode lead so that when the bifurcation 57 is held against the electrode lead 3, they form a tight fit with the electrode lead 3.

[0141] Fig.31 An example similar to Fig.29 , except that the resiliently biased prongs 59 extend from a side surface of the sleeve portion 55 rather than an end of the sleeve portion 55 .

[0142] In any of the above examples, the anti-migration member 32 may include Fig.30 The openings shown may alternatively be porous to allow tissue ingrowth which would improve the anchoring of the electrode lead 3 .

[0143] It will be appreciated that in various examples, a method similar to Figure 29 to Figure 31 The sleeve portion 55 shown in the figure attaches any of the above-mentioned anti-migration members 32 to the electrode lead 3. The sleeve portion 55 can be slid on the electrode lead 3. The sleeve portion 55 can be fixed to the electrode lead 3 by adhesive, welding, crimping or by friction fit. In some examples, the sleeve portion 55 (and one or more anti-migration members 32) can be overmolded on the electrode lead 3.

[0144] In the above Figures 10 to 29 In the example of FIG. 5 , it may be advantageous to prevent the electrode lead 3 from rotating within the second needle 13 , such as by preventing the anti-migration member 32 from aligning with the opening 18 in the second needle 13 before the second needle 13 is retracted. Fig.32 and Fig.33An example of a second needle 13 and electrode lead 3 having anti-rotation features to achieve this is shown.

[0145] exist Fig.32 In the example of , the electrode lead 3 has two flat portions 61 arranged to abut against two flat surfaces 60 of the second needle 13. In this example, the flat surfaces 60 are arranged on either side of the opening 18 in the second needle 13. The abutment of the flat surfaces 60 and the flat portions 61 prevents the rotation of the electrode lead 3 within the second needle 13, and thus can prevent the anti-migration member from being aligned with the opening 18. The flat portions 61 and the flat surfaces 60 can extend completely along the electrode lead 3 and the second needle 13, or only along a portion of the electrode lead 3 and the second needle 13. In the example, the flat portions 61 extend only partially along the electrode lead 3 in the region corresponding to the anti-migration member.

[0146] exist Fig.33 In the example of , the second needle 13 includes protrusions 63a, 63b extending from one side of the electrode lead 3. The protrusions 63a, 63b can be elongated, extending partially or completely along the length of the electrode lead 3, or they can be non-elongated and can be, for example, in the form of a boss. Preferably, the protrusions 63a, 63b are aligned with (at least) the anti-migration member on the electrode lead 3. The protrusions 63a, 63b are accommodated in the narrow grooves 62a, 62b formed on the inner surface of the second needle 13. The narrow grooves 62a, 62b and the protrusions 63a, 63b cooperate to prevent the rotation of the electrode lead 3 in the second needle 13.

[0147] Fig.34 and Fig.35 Additional example electrode leads 3 including anti-migration members 32 are shown. In these examples, the anti-migration member 32 is formed at the top end 35 of the electrode lead 3. The anti-migration member 32 includes a ridge portion 64 having a plurality of circumferential ridges. The circumferential ridges may be different or may form a spiral. As shown, the circumferential ridges of the ridge portion 64 may be angled or tapered, with a tapered surface facing the top end 35 and a flat surface facing another direction. This may improve the anchoring effect of the anti-migration member 32.

[0148] Once the electrode lead 3 is implanted, the ridged portion 64 can be used to prevent the electrode lead 3 from being pulled out of the patient's tissue. After implantation, tissue can grow / heal between the ridges to further anchor the electrode lead 3 in the patient's tissue. Fig.34 In the example of FIG. 5 , the ridge portion 64 is generally cylindrical and is Fig.35 In the example shown in FIG. 5 , the ridge portion 64 tapers toward the top 35 .

[0149] In the example shown, the ridge portion 64 is arranged at the top end 35 of the electrode lead 3. In other examples, one or more ridge portions 64 may be provided, and they may additionally or alternatively be located between the electrodes 4 on the electrode lead 3.

[0150] It will be appreciated that the ridge portion or portions 64 may be combined with any of the other example anti-migration members described above.

[0151] Throughout the description and claims of this specification, the words "comprise" and "contain" and their variations mean "including but not limited to", and they are not intended to (and do not) exclude other components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural, unless the context requires otherwise. In particular, where the indefinite article is used, this specification should be understood to contemplate the plural as well as the singular, unless the context requires otherwise.

[0152] Features, integers, characteristics or groups described in conjunction with a particular aspect, embodiment or example of the invention will be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The invention is not limited to the details of any foregoing embodiments. The invention extends to any novel one or any novel combination of features of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one or any novel combination of steps of any method or process so disclosed.

Claims

1. A neural implant system for percutaneously delivering a neural implant into a patient's tissue, the neural implant system comprising: A neural implant having a housing portion and an elongated electrode lead, and A conveying device, comprising: - handle, - a first needle fixed to the handle and having an inner lumen adapted to accommodate the housing part of the neural implant, - a second needle having a higher gauge number than the first needle, the second needle comprising a retaining portion partially surrounding the elongated electrode lead and an open side extending at least partially along the length of the second needle, wherein the second needle is retractably mounted to the housing and is retractable to deploy the electrode lead in patient tissue, wherein the electrode lead includes a resiliently biased anti-migration member aligned with the retaining portion of the second needle so as to be constrained prior to deployment, and wherein the resiliently biased anti-migration member is configured to move to a deployed position after retraction of the second needle.

2. The neural implant system according to claim 1, wherein: The retaining portion of the second needle comprises a wall having a recess arranged to accommodate the resiliently biased anti-migration member.

3. The neural implant system according to claim 2, wherein: The recess is an opening extending through the wall of the retaining portion.

4. The neural implant system according to any one of claims 1 to 3, wherein: The electrode lead includes a plurality of resiliently biased anti-migration members.

5. The neural implant system according to any one of claims 1 to 4, wherein: The delivery device includes a pusher operable to push the housing portion out of the first needle.

6. The neural implant system according to any one of claims 1 to 5, wherein: The neural implant includes one or more resiliently biased anti-migration members disposed on the housing portion.

7. The neural implant system according to claim 6, wherein: The first needle comprises a wall having a recess arranged to accommodate the resiliently biased anti-migration member.

8. The neural implant system according to any one of claims 1 to 7, wherein: The electrode lead includes an electrode, and wherein the resiliently biased anti-migration member is disposed on the electrode lead between the electrode and the housing portion.

9. The neural implant system according to any one of claims 1 to 8, wherein: The or each resiliently biased anti-migration member may comprise a fin.

10. The neural implant system according to claim 9, wherein: The fins are foldable against the neural implant.

11. The neural implant system according to claim 8 or claim 9, wherein: The fins are shaped to be angled towards the user's skin when implanted.

12. The neural implant system according to any one of claims 1 to 8, wherein: The resiliently biased anti-migration member includes a bifurcation.

13. The neural implant system of claim 12, wherein: The resiliently biased anti-migration member includes a plurality of prongs.

14. The neural implant system of claim 13, wherein: A first fork of the plurality of forks is oriented in an opposite direction from a second fork of the plurality of forks.

15. The neural implant system according to any one of claims 1 to 8, wherein: The resiliently biased anti-migration member includes a hook.

16. The neural implant system of claim 15, wherein: The hooks include a shape memory material, for example a shape memory metal alloy, such as Nitinol, or a shape memory polymer.

17. A neural implant system according to claim 15 or claim 16, wherein: The hook is oriented toward the housing portion.

18. The neural implant system according to any one of claims 1 to 8, wherein: The resiliently biased anti-migration member comprises a stent.

19. The neural implant system of claim 18, wherein: The stent includes a collapsible frame that is resiliently biased to an expanded position.

20. The neural implant system according to any one of claims 1 to 8, wherein: The resiliently biased anti-migration member comprises a coil.

21. The neural implant system according to any one of claims 9 to 20, wherein: The resiliently biased anti-migration member is disposed at or near a distal tip of the elongated electrode lead.

22. The neural implant system according to any one of claims 1 to 21, wherein: The resiliently biased anti-migration member includes a shape memory member embedded within the electrode lead.

23. The neural implant system of claim 22, wherein: The shape memory member is resiliently biased into a non-linear form, and wherein the second needle maintains the elongated electrode lead in a substantially linear form prior to retraction of the second needle.

24. The neural implant system according to any one of claims 1 to 8, wherein: The second needle includes an opening extending longitudinally along a side of the second needle, wherein the resiliently biased anti-migration member includes a resiliently biased fork disposed on the electrode lead, and wherein a width of the resiliently biased fork is greater than a width of the opening in the second needle.

25. The neural implant system of claim 24, wherein: The spring-biased prong has a first end attached to the electrode lead and a second end that is a free end, and wherein a width of the spring-biased prong at the second end is greater than a width of the spring-biased prong at the first end.

26. A neural implant system according to claim 24 or claim 25, wherein: The resiliently biased tines are curved.

27. A neural implant system according to any one of claims 1 to 8 or claims 24 to 26, wherein: The second needle includes an opening extending longitudinally along a side of the second needle, wherein the resiliently biased anti-migration member includes a resiliently biased prong disposed on the electrode lead, and wherein the resiliently biased prong is arranged not to be aligned with the opening of the second needle.

28. A neural implant system according to any preceding claim, wherein: The resiliently biased anti-migration member includes a sleeve portion that surrounds a portion of the electrode lead to secure the resiliently biased anti-migration member to the electrode lead.

29. A neural implant system according to any preceding claim, wherein: The second needle and the electrode lead include anti-rotation features.

30. A neural implant system according to any preceding claim, wherein: The electrode lead also includes one or more ridge portions.

31. A method of percutaneously delivering a neural implant into tissue of a patient, the method comprising: A neural implant system according to any one of claims 1 to 30 is provided, positioning the second needle percutaneously in the patient's tissue at a desired anatomical location, retracting the second needle to release the electrode lead into tissue, and The anti-migration member is deployed.

32. A medical implant for percutaneous implantation into patient tissue via a delivery device, the medical implant comprising a resiliently biased anti-migration member adapted to move from a retracted position when the medical implant is received in the delivery device to a deployed position when the medical implant is released from the delivery device.

33. The medical implant of claim 32, further comprising a housing portion and an elongated electrode lead extending from the housing portion.

34. The medical implant of claim 33, wherein: The resiliently biased anti-migration member is disposed on the electrode lead and / or on the housing portion.

35. The medical implant according to any one of claims 32 to 34, wherein The resiliently biased anti-migration member comprises one or more of the following: a fin protruding from the medical implant, a bifurcation protruding from the medical implant, a hook protruding from the medical implant, a stent protruding from said medical implant, a coil protruding from the medical implant, and / or A shape memory member is embedded in the electrode lead.

36. A delivery device for percutaneously implanting a neural implant into a patient's tissue, wherein: The neural implant has a housing portion and an elongated electrode lead extending from the housing portion, and wherein the delivery device comprises: handle, a first needle secured to the handle and having an inner lumen adapted to receive the housing portion of the neural implant, a second needle having a higher gauge number than the first needle, the second needle comprising a retaining portion partially surrounding the elongated electrode lead and an open side extending at least partially along the length of the second needle, wherein the second needle is retractably mounted to the housing and is retractable to deploy the electrode lead in patient tissue, and Wherein, the retaining portion includes a recess to accommodate the resiliently biased anti-migration member of the neural implant within the second needle.

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