Neural implant system and method

Abstract

The present invention provides a nerve implant system for transcutaneously delivering a nerve implant (1) to a patient's tissue. The nerve implant system comprises a nerve implant (1) having a housing portion (2) and an elongated electrode lead wire (3), and a delivery device (10) having a handle (11), a first needle (12), and a second needle (13). The first needle (12) is fixed to the handle, and the lumen of the first needle is configured to accommodate the housing portion of the nerve implant. The gauge of the second needle (13) is larger than the gauge of the first needle, and the second needle comprises a holding portion that partially surrounds the electrode lead wire and an open side surface that extends at least partially along the length of the second needle. The second needle is retractable to place the electrode lead wire in the patient's tissue. The electrode lead wire (3) comprises an elastically biased displacement prevention member (32). The displacement prevention member is aligned with the holding portion of the second needle so as to be constrained prior to deployment. The displacement prevention member is configured to move to a deployed position after retraction of the second needle.

Description

Technical Field

[0001] The present invention relates to a nerve implant system for transcutaneously delivering a nerve implant to a patient's tissue, a method for transcutaneously delivering a nerve implant, and a medical implant.

Background Art

[0002] It is known to provide an implantable nerve stimulation device including a housing and electrodes. In this case, a power antenna, a microcontroller, and a communication antenna are disposed in the housing to receive power from an external power source and receive / transmit sensor information regarding the electrodes. A delivery system may be used to dispose the implantable nerve stimulation device in a patient's body (particularly, in the vicinity of a nerve). In this case, an incision is made in the patient, and the nerve stimulation device is disposed by passing the delivery system through the incision.

Summary of the Invention

[0003] According to the present disclosure, a nerve implant system for transcutaneously delivering a nerve implant to a patient's tissue is provided. The nerve implant system includes a nerve implant having a housing portion and an elongated electrode lead wire, and a delivery device having a handle, a first needle, and a second needle. The first needle is fixed to the handle, and the lumen of the first needle is configured to accommodate the housing portion of the nerve implant. The gauge of the second needle is larger than the gauge of the first needle. The second needle includes a holding portion that partially surrounds the electrode lead wire and an open side surface that extends at least partially along the length of the second needle. The second needle is retractably attached to a housing (handle) and is retractable to place the electrode lead wire in the patient's tissue. The electrode lead wire includes an elastically biased displacement prevention member (migration prevention member, movement prevention member). The displacement prevention member is aligned with the holding portion of the second needle so as to be constrained before deployment (before placement). The displacement prevention member is configured to move to a deployed position (placement position) after retraction of the second needle.

[0004] In some examples, the elastically biased displacement prevention member (migration prevention member, movement prevention member) is an elastically deformable member.

[0005] In some examples, the holding portion of the second needle may include a wall portion having a recess configured to receive the displacement prevention member. In some examples, the recess may be an opening that penetrates the wall portion of the holding portion.

[0006] In some examples, the electrode lead wire may include a plurality of the displacement prevention members.

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

[0008] In some examples, the nerve implant may also be provided with one or more elastically biased misalignment prevention members in the housing portion. In some examples, the first needle may include a wall portion having a recess configured to receive the misalignment prevention member of the housing portion.

[0009] In some examples, the electrode lead wire may include an electrode, and the misalignment prevention member of the electrode lead wire may be disposed between the electrode and the housing portion.

[0010] In some examples, the misalignment prevention member may include fins. The fins may be foldable with respect to the nerve implant. The fins may be shaped so as to be angled toward the user's skin when implanted.

[0011] In some examples, the misalignment prevention member may include sharp teeth (tongue-shaped or branched portions). The misalignment prevention member may include a plurality of the teeth. In some examples, a first tooth among the plurality of teeth may be oriented in a direction opposite to that of a second tooth among the plurality of teeth.

[0012] In some examples, the misalignment prevention member may include hooks. In some examples, the hooks may include a shape memory material such as a shape memory alloy or a shape memory polymer such as nitinol. In some examples of implementation, the hooks may be provided so as to face the housing portion.

[0013] In some examples, the misalignment prevention member may include a stent. In some examples, the stent may include a foldable frame elastically biased to an expanded position.

[0014] In some examples, the misalignment prevention member may include one or more coils.

[0015] In some examples, the misalignment prevention member may be disposed at the distal end of the electrode lead wire or around (in the vicinity of) the distal end.

[0016] In some examples, the misalignment prevention member may include a shape memory member embedded in the electrode lead wire. The shape memory member may be elastically biased in a non-linear shape. The second needle may hold the electrode lead wire in a linear shape before retraction of the second needle.

[0017] In some examples, the second needle includes an opening extending longitudinally along one side surface of the second needle. In such an example, the misalignment prevention member may include an elastically biased sharp tooth portion disposed on the electrode lead wire, and the width of the tooth portion may be larger than the width of the opening of the second needle. In other examples, the misalignment prevention member may include an elastically biased sharp tooth portion disposed on the electrode lead wire, and the tooth portion may be disposed so as not to be aligned with the opening of the second needle.

[0018] In some examples, the tooth portion has a first end attached to the electrode lead wire and a second end that is a free end. The width of the tooth portion at the second end may be larger than the width of the tooth portion at the first end. In some examples, the tooth portion is curved.

[0019] In various examples, the misalignment prevention member includes a sleeve portion that surrounds a part of the electrode lead wire so as to fix the misalignment prevention member to the electrode lead wire. The sleeve portion may be attached to the electrode lead wire by, for example, adhesion, welding, crimping, or friction fitting. In some examples, the sleeve portion may be overmolded on the electrode lead wire.

[0020] In some examples, the elastically biased anti-displacement member (anti-migration member, anti-movement member) may have one or more openings for tissue growth after implantation.

[0021] In some examples, the second needle and the electrode lead wire include a rotation prevention mechanism (rotation prevention member). The rotation prevention mechanism cooperates to prevent rotation of the electrode lead wire within the second needle. The rotation prevention mechanism may extend partially or entirely along the second needle and / or may extend partially or entirely along the electrode lead wire. Preferably, the rotation prevention mechanism (rotation prevention member) on the electrode lead wire is aligned with the elastically biased anti-displacement member (anti-migration member, anti-movement member). In some examples, the rotation prevention mechanism includes flat opposing surfaces that abut to prevent rotation. In some examples, the rotation prevention mechanism includes a protrusion and a slot that receives the protrusion to prevent rotation.

[0022] In some examples, the electrode lead wire further includes one or more raised portions.

[0023] According to another aspect of the present invention, a method for percutaneously delivering a nerve implant into a patient's tissue is provided. The method includes providing the nerve implant system described above, percutaneously placing the second needle into the patient's tissue at a desired anatomical location, retracting the second needle to release the electrode lead wire into the tissue, and implanting the anti-displacement member.

[0024] According to another aspect of the present invention, there is provided a medical implant that is percutaneously implanted into a patient's tissue by a delivery device. The medical implant includes an elastically biased displacement prevention member (migration prevention member, movement prevention member), and the displacement prevention member is movable from a retracted position where the medical implant is housed in the delivery device to a deployed position (implantation position) where the medical implant is released from the delivery device.

[0025] In some examples, the medical implant may further include a housing portion and an elongated electrode lead extending from the housing portion. In some examples, the displacement prevention member may be provided (disposed) on the electrode lead and / or the housing portion.

[0026] In various examples, the displacement prevention member includes one or more of a fin protruding from the medical implant, a sharp tooth portion (tongue-shaped portion or branched portion) protruding from the medical implant, a hook protruding from the medical implant, and a stent protruding from the medical implant.

[0027] According to another aspect of the present invention, there is provided a delivery device for percutaneously implanting a nerve implant into a patient's tissue. In the delivery device, the nerve implant has a housing portion and an electrode lead extending from the housing portion. The delivery device includes a handle, a first needle fixed to the handle, the first needle having a lumen configured to accommodate the housing portion of the nerve implant, and a second needle having a larger gauge than the first needle, the second needle having a holding portion that partially surrounds the electrode lead and an open side surface that extends at least partially along the length of the second needle, and the second needle is retractably attached to a housing (handle) and is retractable to implant the electrode lead into the patient's tissue. The holding portion has a recess for accommodating an elastically biased displacement prevention member in the nerve implant within the second needle.

Brief Description of the Drawings

[0028] Embodiments of the present invention will be further described with reference to the following attached drawings.

[0029]

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Embodiments for Carrying Out the Invention

[0030] FIG. 1 schematically shows a medical implant 1. In some examples, the medical implant 1 may be a nerve implant (for example, a nerve stimulation implant or a diagnostic implant). The medical implant 1 includes a housing portion 2 and an elongated electrode lead wire 3. The housing portion 2 houses electronic components (electronic devices) of the medical implant 1 (for example, a printed circuit board, a wireless communication receiver and a wireless communication transmitter, a wireless power receiver, and / or a sensor electronic device) as described later. In some examples, the housing portion 2 is hermetically sealed. The housing portion 2 may be composed of a cylindrical casing with both ends sealed, or may be composed of a packaging material or other enclosure that surrounds the electronic components within the housing portion 2.

[0031] In some examples, the electrode lead wire 3 extends from the housing portion 2 and has flexibility (flexibility). The electrode lead wire 3 includes at least one electrode 4. In some examples, the electrode lead wire 3 includes a plurality of electrodes 4 arranged at intervals in the length direction of the electrode lead wire 3. The electrode 4 is connected to the electronic components within the housing portion 2.

[0032] In some examples, the diameter of the housing portion 2 may be from about 0.5 millimeter to about 5 millimeters, for example, from about 1 millimeter to about 3 millimeters. The length of the housing portion 2 may be about 10 millimeters or less (for example, about 5 millimeters or less). In some examples, the diameter of the electrode lead wire 3 may be from about 0.3 millimeter to about 1.5 millimeters, for example, from about 0.5 millimeter to 1.3 millimeters. The length of the electrode lead wire 3 may be about 100 millimeters or less (for example, about 50 millimeters or less), for example, about 50 millimeters. However, since the dimensions of the housing portion 2 correspond to the size of the electronic component housed in the housing portion 2, and the length of the electrode lead wire 3 corresponds to the anatomical structure around the target nerve, it will be understood that a shorter or longer electrode lead wire 3 may be appropriate depending on the depth of the nerve in the muscle tissue.

[0033] As further described below, the medical implant 1 is implantable in a patient's body and operable to detect and / or stimulate a nerve. In some examples, the medical implant 1 is implantable to detect and / or stimulate the greater occipital nerve, but the same or a similar implant may be implantable to detect and / or stimulate other nerves (particularly, other peripheral nerves of the peripheral nervous system). In some examples, the medical implant 1 may be implantable to detect and / or stimulate the tibial nerve, the sacral nerve (for example, for the treatment of urinary incontinence), or the vagus nerve (for example, for the regulation of pancreatic juice secretion).

[0034] FIG. 2 shows the medical implant 1 implanted in a patient. The medical implant 1 is disposed under the surface of the skin 5 (particularly, under the epidermis). The housing portion 2 may be disposed in the dermis 6 or the subcutaneous tissue 7. By disposing the housing portion 2 in the subcutaneous tissue 7, damage and irritation to the patient can be reduced.

[0035] As shown in the figure, the electrode lead wire 3 extends from the housing part 2 through the lower tissue (especially, the muscle 8) to the position of the adjacent part (periphery) of the target nerve 9. The electrode lead wire 3 is arranged such that the electrode 4 (see FIG. 1) contacts or is close to the nerve 9. Thereby, it becomes possible to detect and / or stimulate the nerve 9 using the electrode 4. In some examples, the electrode lead wire 3 may be embedded so as to be substantially parallel to the nerve 9 at least in the region of the electrode 4.

[0036] The medical implant 1 may include one or more displacement prevention members (migration prevention members, movement prevention members). The displacement prevention members (migration prevention members, movement prevention members) may be provided on the housing part 2 and / or the electrode lead wire 3, and function to hold the medical implant 1 at a predetermined position within the patient's tissue.

[0037] In some examples, the medical implant 1 is battery - less and does not have an integrated power source. The external device 52 can wirelessly supply power to the medical implant 1. The external device 52 can further wirelessly communicate with the medical implant 1 (especially, the electronic components within the housing part 2). The medical implant 1 may include a wireless communication receiver / wireless communication transmitter for communicating with the external device 52. The medical implant 1 may have a processor or a controller configured to operate the medical implant 1. The external device 52 may be arranged on the skin of the adjacent part (peripheral part) of the medical implant 1. The external device 52 may be attached to the skin of the adjacent part (peripheral part) of the medical implant 1. The external device 52 may be a wearable device.

[0038] In some examples, the medical implant 1 is a nerve implant. The medical implant 1 can be implanted targeting a specific nerve or nerve group (for example, the greater occipital nerve, etc.).

[0039] During operation, an electrical signal such as a current is supplied to electrode 4 of the implant for nerve stimulation to stimulate a nerve or target tissue. In some examples, the electrical signal may be a voltage-controlled stimulation. Such stimulation can bring about the alleviation of various symptoms, such as sleep disorders (hypoglossal nerve and / or cervical nerve trap), chronic pain (e.g., occipital neuralgia, intractable migraine, etc.), and / or other therapeutic effects.

[0040] In other examples, medical implant 1 may be a diagnostic implant (e.g., a nerve diagnostic implant) operable to detect one or more nerve signals within a nerve. In such examples, electrode 4 is operable to detect nerve signals. The nerve signals may be analyzed for the purpose of detecting, monitoring, and / or diagnosing a condition (disease).

[0041] In other examples, the diagnostic implant (medical implant 1) may operate to additionally or alternatively detect one or more patients' vital signs (e.g., body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentration (oxygen, carbon dioxide, carbon monoxide, etc.)).

[0042] Figures 3A to 3C show alternative examples of medical implant 1.

[0043] In the example of Figure 3A, medical implant 1 includes a housing portion 2, an electrode lead wire 3, and an electrode 4 formed on the electrode lead wire 3. The housing portion 2 includes a casing 2a. The casing 2a may be cylindrical and can accommodate electronic components therein. The housing portion 2 includes a wireless power receiver 35 for receiving wireless power from an external device 52 (see Figure 2) after being implanted in the patient's body.

[0044] In the example of FIG. 3B, the medical implant 1 does not include the electrode lead wire 3, and the electrode 4 is formed on the housing portion 2. The example of FIG. 3B may be a nerve implant (for example, a nerve stimulation implant or a diagnostic implant that can be implanted in the vicinity of a nerve in the same manner as described above). In this example, the casing 2a of the housing portion 2 includes the electrode 4 separated (isolated) by the insulating region 34. In some examples, as shown, the housing portion 2 also holds the wireless power supply receiver 35. The wireless power supply receiver 35 is disposed within the housing portion 2 and may be spaced apart from the electrode 4.

[0045] In the example of FIG. 3C, the medical implant 1 is used in combination with another medical implant 73. The other medical implant 73 may be a deep tissue implant (for example, a pacemaker). In these examples, the medical implant 1 may function as a wireless power supply receiver or a wireless power supply relay of another medical implant 73. In the example of FIG. 4A, the medical implant 1 may be connected to another medical implant 73 by the wire 74. The medical implant 1 includes the wireless power supply receiver 35 as described above and transmits power to another medical implant 73 via the wire 74. The medical implant 1 may be implanted at a shallower position in the tissue than another medical implant 73. Thereby, the wireless power supply coupling is improved by shortening the distance from the external wireless power supply transmitter. In the example of FIG. 4B, the medical implant 1 includes the wireless power supply receiver 35 and the wireless power supply transmitter 75, and is arranged (configured) to relay power to the wireless power supply receiver 76 of another medical implant 73. The wireless power supply transmitter 75 of the medical implant 1 may be connected to the housing portion 2 by the wire 77 as shown, or the wireless power supply transmitter 75hs may be provided within the housing portion 2 and the wire 77 may be omitted. The medical implant 1 may be implanted at a shallower position in the tissue than another medical implant 73. Thereby, the wireless power supply coupling is improved.

[0046] Figure 4 shows an example of a delivery device 10 for implanting a medical implant 1 into a patient's tissue. In particular, the delivery device 10 is used to implant the medical implant 1 percutaneously at the position shown in FIG. 2. The delivery device 10 is illustrated with reference to an exemplary medical implant 1 (specifically, a nerve stimulation implant) having a housing portion 2 and an electrode lead wire 3 as shown in FIG. 3A. However, it will be understood that the delivery device 10 may also be adapted for the implantation of other medical implants 1 described above with reference to FIGS. 3A-3C.

[0047] In the example of FIG. 4, the delivery device 10 has a delivery sheath that 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 to each other 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 tip 14 (e.g., a beveled tip), and the second needle 13 extends beyond the tip 14 of the first needle 12. The second needle 13 also has a tip 15 (in particular, a beveled tip). The gauge of the second needle 13 is larger than the gauge of the first needle 12 (i.e., the diameter of the second needle 13 is smaller than the diameter of the first needle 12).

[0048] In use, the housing portion 2 of the medical implant 1 is received within the first needle 12 (specifically, the lumen of the first needle 12). In use, the electrode lead wire 3 is received within the second needle 13 (specifically, the lumen of the second needle 13). The electrode lead wire 3 extends along most of the second needle 13 towards the tip 15 as shown. As further described with reference to FIG. 6, a portion of the electrode lead wire 3 adjacent to the housing portion 2 extends through the opening of the second needle 13. Thus, in use, the medical implant 1 is received within the first needle 12 and the second needle 13 of the delivery device 10.

[0049] As shown in the illustration, the first needle 12 and the second needle 13 are offset when viewed from the axial direction. In particular, the central axis of the first needle 12 is offset from the central axis of the second needle 13. In the illustrated example, the second needle 13 extends into the first needle 12 (in particular, the lumen of the first needle 12), and the second needle 13 is partially accommodated within the first needle 12 along the housing portion 2.

[0050] Referring to FIG. 6, the second needle 13 has an opening 18 (i.e., a slot) as an open side surface. Thereby, a part of the electrode lead wire 3 can extend from the second needle 13 and be connected to the housing portion 2. The opening 18 may extend to the tip 15 of the second needle 13. The opening 18 may extend along most of the second needle 13, or may extend along the entire length of the second needle 13.

[0051] Referring to FIG. 4, during use, the first needle 12 penetrates the patient's tissue percutaneously and positions the housing portion 2 at a first depth, and the second needle 13 penetrates the patient's tissue percutaneously and positions the electrode lead wire 3 at a second depth. When the electrode lead wire 3 is correctly positioned, the delivery device 10 releases (ejects) the medical implant 1 and implants (deploys) it, leaving the medical implant 1 in the position shown in FIG. 2. In some examples, after the electrode lead wire 3 is implanted, the delivery device 10 may be rotated so that the housing portion 2 is angled and implanted with respect to the electrode lead wire 3. The delivery device 10 may be rotated while the first needle 12 is outside the patient's body (i.e., while it is not percutaneously positioned). The tip 14 of the first needle 12 and the tip 15 of the second needle 13 are each sharp tips configured to puncture the patient's skin and penetrate the tissue to percutaneously position the first needle 12 and the second needle 13 at an appropriate depth. The tip 14 of the first needle 12 and the tip 15 of the second needle 13 may be beveled tips, as is well known to those skilled in the art. In some examples, during use, the first needle 12 and the second needle 13 are used to puncture the patient's skin and underlying tissue, and in some examples, after an incision is first made, the first needle 12 and the second needle 13 are inserted into the patient's tissue through the incision.

[0052] In some examples, the gauge of the first needle 12 may be from 6 gauge to 15 gauge, for example, it may be 10 gauge. In some examples, the gauge of the second needle 13 may be from 15 gauge to 25 gauge, for example, it may be 20 gauge.

[0053] In some examples, the second needle 13 is retractable (storable) relative to the first needle 12 for placing (deploying) the electrode lead wire 3. The opening 18 (see FIG. 6) along the second needle 13 enables the placement (deployment) of the electrode lead wire 3 when the second needle 13 is retracted.

[0054] In some examples, the housing part 2 is detachably attached to the first needle 12 (or another part of the delivery device 10) and is released before placement (deployment).

[0055] In some examples, by pulling the delivery device 10 (implant delivery device) away from the patient, utilizing the friction between the electrode lead wire 3 and the patient's tissue to hold the medical implant in place, and simply pulling the housing part 2 away from the first needle 12, the housing part 2 can be placed (deployed) from the first needle 12. In other examples, the delivery device 10 may include a placement member (deployment member) (for example, a pusher) configured to push the housing part 2 out of the first needle 12 and place (deploy) the housing part 2 at an appropriate anatomical site. In some examples, the delivery device 10 (implant delivery device) may include a holding member configured to hold the housing part 2 within the first needle 12 before placement, and may be operable to release (unlock) the housing part 2 before the delivery device 10 is removed.

[0056] FIGS. 5A - 5C show the operation of the delivery device 10 of FIG. 4.

[0057] As shown in the illustration, the exemplary delivery device 10 further includes a handle 11. The handle 11 is configured to be graspable by an operator. The first needle 12 is fixed to the handle 11.

[0058] The second needle 13 extends through the first needle 12 and the handle 11. An actuating tab (grip portion) 16 is provided at an end of the second needle 13 opposite to the tip 15. In particular, the actuating tab 16 may be a grip handle or the like for an operator to hold.

[0059] The second needle 13 is a retractable portion (storage portion) that can be retracted (stored) with respect to the first needle 12. In particular, the second needle 13 can slide through the first needle 12 and the handle 11 from the position shown in FIG. 5A to the position shown in FIG. 5B. In this example, by pulling the actuating tab 16 in a direction away from the patient, the second needle 13 can be retracted (stored). When the second needle 13 is retracted in this way, the electrode lead 3 is placed. The opening 18 (see FIG. 6) along the second needle 13 provides a connection portion between the electrode lead 3 and the housing portion 2. The opening 18 extends to the tip 15 of the second needle 13.

[0060] A locking device 17 is provided to lock the second needle 13 to the handle 11 and / or the first needle 12. As shown in the illustration, the locking device 17 may be provided on the actuating tab 16 or in its vicinity (adjacent portion), and in some examples, locks the actuating tab 16 and / or the second needle 13 to the handle 11. The locking device 17 locks the second needle 13 in the position shown in FIG. 5B (retracted position).

[0061] At the position shown in FIG. 5A, the operator can percutaneously place the implant delivery device (delivery device 10) into the patient's tissue. Since the position of the second needle 13 is locked with respect to the handle 11, the operator can push the delivery device 10 into the patient's body by the handle 11.

[0062] Referring to FIGS. 5A and 2, when the delivery device 10 is pushed into the patient's body, first the second needle 13 penetrates the skin 5, and when the delivery device 10 is pushed further, the first needle 12 penetrates the skin 5. As a result, the first needle 12 and the second needle 13 are arranged at an appropriate depth within the patient's body, and at the same time, the housing portion 2 and the electrode lead wire 3 are also arranged at an appropriate depth. Therefore, the delivery device 10 enables the percutaneous delivery of the medical implant 1 into the patient's tissue.

[0063] In some examples, the operator may use an ultrasonic imaging device to monitor the position of the second needle 13 (and the first needle 12) and guide the second needle 13 towards the target nerve 9.

[0064] When the delivery device 10 is arranged at a predetermined position, the tip 15 of the second needle 13 (and the electrode lead wire 3 within the second needle 13) is arranged in the vicinity of the nerve, and the tip 14 of the first needle 12 (and the housing portion 2 within the first needle 12) is arranged within the subcutaneous tissue 7, the second needle 13 can be partially retracted (stored) to a position between the position shown in FIG. 5A and the position shown in FIG. 5B. In particular, the second needle 13 can be partially retracted to expose the electrode 4 (see FIG. 3A). At this position (retracted position), the position of the electrode 4 (see FIG. 3A) can be inspected. If necessary, the second needle 13 can be extended again to the position shown in FIG. 5A and repositioned.

[0065] When the electrode lead wire 3 is appropriately arranged, the second needle 13 is retracted to the position shown in FIG. 5B, and the electrode lead wire 3 is left in place.

[0066] Release the lock of the locking device 17 (locking mechanism) and pull the operating tab 16 with respect to the handle 11 so as to slide the second needle 13 to the retracted position (storage position) shown in FIG. 5B, whereby the second needle 13 is retracted. The operating tab 16 is pulled in a direction away from the patient. While the second needle 13 is being retracted, the handle 11 and the first needle 12 remain stationary. As shown in the figure, when the second needle 13 is retracted, the electrode lead wire 3 is left in place and exposed to the surrounding tissue (and nerve).

[0067] Next, as shown in FIG. 5C, the delivery device 10 is withdrawn from the patient's body, and the housing portion 2 is left on the first needle 12. In this example, the friction between the electrode lead wire 3 and the tissue (see the muscle 8 in FIG. 2) is sufficient to hold the medical implant 1 in place when the delivery device 10 is withdrawn. Thereby, when the delivery device 10 is withdrawn from the patient's body, the housing portion 2 is left on the first needle 12.

[0068] In other examples, the delivery device 10 may include a retention member (e.g., a pusher within the first needle 12) configured to push the housing portion 2 off the first needle 12. In some examples, the delivery device 10 may have a retention member configured to removably attach the housing portion 2 to the first needle 12 and / or the handle 11. The retention member may release the housing portion 2 after the second needle 13 has been retracted and before the first needle 12 is removed from the patient's body.

[0069] Figures 6, 7A, and 7B show the first needle 12 and the second needle 13 in the delivery device 10 described above. As shown, the electrode lead wire 3 is housed in the second needle 13, and the second needle 13 has a slot (opening 18) for connecting the electrode lead wire 3 to the housing portion 2 within the first needle 12. The slot (opening 18) extends partially along the second needle 13 from the tip 15 and may extend over most or the entire length of the second needle 13. The second needle 13 may have a sheath shape. The first needle 12 houses the housing portion 2.

[0070] The first needle 12 has a beveled tip 14. The second needle 13 has a beveled tip 15. The beveled tips 14, 15 are sharpened so as to be able to pierce the patient's skin and penetrate the tissue during use.

[0071] As shown in Figure 6, the second needle 13 extends through the lumen of the first needle 12. In particular, as shown in Figure 7B, the first needle 12 has a first portion (main portion) 19A and a second portion (sub portion) 19B. The first portion 19A and the second portion 19B are joined (integrated) such that the first needle 12 has a single lumen. The first portion 19A and the second portion 19B are shaped to define two distinguishable portions 19A, 19B.

[0072] The first portion 19A is formed in a shape capable of housing the housing portion 2. In particular, the first portion 19A has a size capable of housing the housing portion 2 and has a substantially circular cross section for holding the housing portion 2 in an axially aligned state within the first portion 19A.

[0073] The second portion 19B is formed in a shape capable of housing the second needle 13. In particular, the second portion 19B has a size capable of housing the second needle 13 and has a substantially circular cross section for holding the second needle 13 in an axially aligned state within the second portion 19B.

[0074] In some examples, the second part 19B and the first part 19A each have a substantially circular cross-section that at least partially overlaps. In such an example, the presence of the second needle 13 within the second part 19B can cause the housing portion 2 to be pushed out to one side of the first part 19A.

[0075] The slot (opening 18) of the second needle 13 is open towards the center of the first needle 12. This enables the electrode lead wire 3 to be connectable to the housing portion 2 as shown in FIG. 6.

[0076] Accordingly, the first needle 12 has a shape that can accommodate the housing portion 2 and the second needle 13, and that enables the second needle 13 to slide towards the retracted position. When the second needle 13 is positioned within the lumen of the first needle 12, during use, the puncture wound formed by the second needle 13 will be enlarged by the first needle 12, which is advantageous in that only one puncture wound is formed in the patient's skin.

[0077] In another example, the second needle 13 does not pass through or into the lumen of the first needle 12. Instead, the second needle 13 may extend through another portion of the handle 11 (e.g., adjacent to the first needle 12).

[0078] In the above examples, the second needle 13 is initially in the extended or retracted position, and the first needle 12 and the second needle 13 may be simultaneously placed within the patient. FIG. 8 shows another example where the second needle 13 is initially in the retracted position. In this example, as shown, the actuating tab 16 extends from the handle 11. In the retracted position, the second needle 13 is either within the first needle 12 as shown, or alongside the first needle 12 within the handle 11. The electrode lead wire 3 is partially within the second needle 13 and is looped between the housing portion 2 and the second needle 13.

[0079] During implantation, when the first needle 12 is inserted into the patient's body using the delivery device 10 in the form shown in FIG. 8, next, by pushing the activation tab 16 towards the handle 11, the second needle 13 is extended beyond the first needle 12 to carry the electrode lead 3 to a predetermined position. At this position, by engaging the lock device 17 (locking mechanism), the activation tab 16 and the second needle 13 can be locked in place.

[0080] In some examples, the delivery device 10 may be removed from the patient with the second needle 13 in the extended position, and a retention member (e.g., a pusher) may be provided to extrude the medical implant 1 from the first needle 12 and the second needle 13. In other examples, after the second needle 13 is extended, by pulling the activation tab 16 away from the handle 11 in the manner described above with reference to FIGS. 5A - 5C, the second needle 13 is retracted, thereby releasing the electrode lead 3 and the housing portion 2.

[0081] FIG. 9 shows an alternative delivery device 10. In this example, the delivery device 10 includes, as described above, a handle 11, a first needle 12 that holds the housing portion 2, and a second needle 13 that holds the electrode lead 3. In this example, the activation tab 16 is configured to be pushed towards the handle 11 (and the patient) to retract the second needle 13.

[0082] In particular, as shown, the delivery device 10 includes a rack and pinion mechanism. The rack and pinion mechanism converts the movement of the activation tab 16 towards the handle 11 into the retraction of the second needle 13 (i.e., moves the second needle 13 in a direction opposite to the activation tab 16).

[0083] As shown in FIG. 9, the rack and pinion mechanism includes a first rack portion 30A. The first rack portion 30A is attached to the second needle 13 or is formed as part of the second needle 13. The rack and pinion mechanism also includes a second rack portion 30B. The second rack portion 30B is attached to the actuating tab 16 or is formed as part of the actuating tab 16. The pinion gear 31 is rotatably mounted within the handle 11 and meshes with both the first rack portion 30A and the second rack portion 30B. The pinion gear 31 may be mounted within the first needle 12 or, as shown, behind the end of the first needle 12 within the handle 11. Thus, when the actuating tab 16 is pushed toward the patient, the rack and pinion mechanism pulls the second needle 13 away from the patient, releasing the electrode lead 3.

[0084] Advantageously, the delivery device 10 can be operated with one hand by pushing the actuating tab 16 rather than pulling it.

[0085] In some examples, it will be understood that the delivery device 10 described above may be configured to implant the medical implant shown in FIG. 3B. In these examples, the second needle 13 is omitted and the delivery sheath is composed of only the first needle 12, and the first needle 12 may be configured to hold the medical implant 1. In such an example, after the first needle 12 is placed percutaneously, the medical implant 1 is discharged (e.g., pushed out) from the first needle 12 to achieve implantation (insertion of the medical implant 1).

[0086] In some examples, it will be understood that the delivery device 10 described above can be configured to implant the medical implant shown in FIG. 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 part 2. The second needle 13 can be retracted as described above to implant the wire 77 and the wireless power transmitter 75.

[0087] After the medical implant 1 is delivered to the position shown in FIG. 2, it includes one or more displacement prevention members (migration prevention members, movement prevention members) 32 configured to hold the medical implant 1 in a predetermined position. FIGS. 10 to 23 show various examples of the displacement prevention member 32. FIGS. 10 to 23 show various displacement prevention members 32 with reference to the medical implant 1 of FIG. 3A including the housing part 2 and the elongated electrode lead wire 3. Each displacement prevention member 32 may be provided on the electrode lead wire 3 and / or on the housing part 2. However, it will be understood that the displacement prevention member 32 described below may be provided on the medical implant 1 described with reference to FIG. 3B. In that case, the displacement prevention member 32 is provided on the housing part 2. Further, the displacement prevention member 32 described below may be provided on the medical implant 1 described with reference to FIG. 3C. In that case, the displacement prevention member 32 may be provided on the housing part 2 and / or on the wire 77 and / or on the wireless power transmitter 75.

[0088] In each of the examples of FIGS. 10 to 22, the displacement prevention member 32 is elastically biased and housed in the delivery sheath before the implantation (deployment) of the medical implant 1. When the medical implant 1 is released from the delivery device 10, the elastically biased displacement prevention member 32 moves to the deployment position (implantation position), and at this position, the displacement prevention member 32 functions to hold the medical implant 1 in a predetermined position within the patient's tissue.

[0089] In the example of FIG. 10, the medical implant 1 (particularly, the electrode lead 3) includes one or more (in this example, three) misalignment prevention members 32. In this example, the misalignment prevention member 32 is an elastically biased fin 33 that protrudes from the side surface of the electrode lead 3. The fin 33 is inclined (towards the proximal side) towards the distal end 35 of the electrode lead 3. The fin 33 is made of an elastically deformable material (e.g., metal (stainless steel), aluminum, nitinol, or a biocompatible polymer). The fin 33 may be a thin sheet-like protrusion. The fin 33 may be integrated with the electrode lead 3 (particularly, the casing or the electrode lead 3), or may be attached by a collar or a clamp.

[0090] Due to the inclined shape (angled shape) of the fin 33, when the electrode lead 3 moves within the patient's tissue and when the electrode lead 3 is accommodated within the delivery sheath of the delivery device 10, the fin 33 deforms towards the electrode lead 3. The fin 33 also serves to prevent the electrode lead 3 from being pulled out from the patient.

[0091] In some examples, the fin 33 can be folded (folded over) against the side surface of the electrode lead 3 within the delivery sheath. In this way, when the electrode lead 3 moves out of the delivery sheath (e.g., when the second needle 13 is retracted), the fin 33 unfolds (due to its elasticity) to the position shown in FIG. 10.

[0092] In other examples, the fin 33 may be received in a recess 34 (or an opening 34) formed in the delivery sheath (e.g., the second needle 13 shown in the figure). The recess 34 can accommodate the fin 33, and the fin 33 deforms so as to move out of the recess 34 when the second needle 13 is retracted. Similarly, the opening 34 can accommodate the fin 33 such that the fin 33 protrudes from the second needle 13, and the fin 33 is deformable so as to move out of the opening 34 during implantation.

[0093] In some examples, the fin 33 may be provided additionally or alternatively on the housing portion 2 of the medical implant. In some examples, the fin 33 may be provided on the housing portion 2 of the medical implant 1 in FIG. 3B. In some examples, the fin 33 may be provided on the housing portion 2, the wire 77, or the wireless power transmission transmitter 75 of the medical implant 1 in FIG. 3C.

[0094] In the example of FIG. 11, the medical implant 1 (particularly, the electrode lead wire 3) includes one or more (three in this example) misalignment prevention members 32. In this example, the misalignment prevention member 32 is an elastically biased sharp tooth portion (tongue-shaped portion or branch-shaped portion) 36 protruding from the side surface of the electrode lead wire 3. In this example, the tooth portions 36 are arranged in pairs on the side surfaces on both sides of the electrode lead wire 3. The tooth portion 36 is attached to the electrode lead wire 3 at one end and protrudes longitudinally along the electrode lead wire 3 in a direction away from the distal end 35 of the electrode lead wire 3. The tooth portion 36 is made of an elastically deformable material (e.g., metal (stainless steel), aluminum, nitinol, or a biocompatible polymer). The tooth portion 36 is a thin sheet-like protrusion. The tooth portion 36 is elastically biased to the position shown in FIG. 11, and at this position, it protrudes obliquely (at an angle) from the electrode lead wire 3.

[0095] The tooth portion 36 may be integrated with the electrode lead wire 3 (particularly, the casing or the electrode lead wire 3). In other examples, the tooth portion 36 may extend from a collar attached to the electrode lead wire 3 or may be clamped and fixed to the electrode lead wire 3.

[0096] Due to the orientation of the tooth portion 36, as the electrode lead wire 3 moves into the patient's tissue, the tooth portion 36 is deformable toward the electrode lead wire 3. The tooth portion 36 also serves to prevent the electrode lead wire 3 from being pulled out of the patient.

[0097] In some examples, prior to implantation (deployment), the tooth portion 36 may be folded against the side surface of the electrode lead 3 within the delivery sheath (e.g., the second needle 13). In this way, the tooth portion 36 moves outward to the position shown in FIG. 11 during implantation (due to its elasticity).

[0098] In some examples, the tooth portion 36 may be received in a recess or opening formed in the delivery sheath (e.g., the second needle), similar to the fin 33 described with reference to FIG. 10.

[0099] In some examples, the tooth portion 36 may be provided additionally or alternatively on the housing portion 2 of the medical implant. In some examples, the tooth portion 36 may be provided on the housing portion of the medical implant 1 in FIG. 3B. In some examples, the tooth portion 36 may be provided on the housing portion 2, wire 77, or wireless power transmitter 75 of the medical implant 1 in FIG. 3C.

[0100] In the example of FIG. 12, similar to the example of FIG. 11, the tooth portion 36 is provided on the electrode lead 3, housing portion 2, wire 77, or wireless power transmitter 75 in the medical implant 1. In this example, a second set of tooth portions 37 is provided in a direction opposite to the above-described tooth portion 36, thereby preventing the medical implant 1 from moving in both directions.

[0101] In the example of FIG. 13, the medical implant 1 (in particular, the electrode lead 3) comprises a misalignment prevention member 32. In this example, the misalignment prevention member 32 is an elastically biased hook 38 that protrudes from the side surface of the electrode lead 3. One end of the hook 38 is attached to the electrode lead 3. The hook 38 protrudes towards the distal end 35 from its proximal end to the intermediate bent portion, and protrudes in a substantially opposite direction from the intermediate bent portion to the tip, thereby forming the hook. The hook 38 is made of an elastically deformable material (preferably, a shape memory material (e.g., stainless steel for springs, or nitinol)). The hook 38 is elastically biased to the position shown in FIG. 13, and at this position, the hook 38 protrudes obliquely (at an angle) from the electrode lead 3.

[0102] The hook 38 may be integrated with the electrode lead 3 (in particular, the casing 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 and fixed to the electrode lead 3.

[0103] Due to the orientation of the hook 38, when the electrode lead 3 moves within the patient's tissue, the hook 38 is deformable towards the electrode lead 3. When deformed radially inward, the hook 38 lies flat against the side surface of the electrode lead 3. When deployed as shown in FIG. 13, the hook 38 acts to prevent the electrode lead 3 from being pulled out of the patient.

[0104] In some examples, the hook 38 may be folded against the side surface of the electrode lead 3 within the delivery sheath (e.g., the second needle 13 shown) prior to implantation (deployment). In this way, the hook 38 moves outward to the position shown in FIG. 13 (due to its elasticity) during implantation.

[0105] In some examples, the hook 38 may be received in a recess 39 (or an opening 39) formed in the delivery sheath (e.g., the second needle 13).

[0106] In some examples, the hook 38 may be provided additionally or alternatively on the housing portion 2 of the medical implant. In some examples, the hook 38 may be provided on the housing portion of the medical implant 1 in FIG. 3B. In some examples, the hook 38 may be provided on the housing portion 2, the wire 77, or the wireless power transmitter 75 of the medical implant 1 in FIG. 3C.

[0107] The example in FIG. 14 is similar to the example in FIG. 13, but a hook 40 is provided at the distal end 35 of the electrode lead wire 3. The hook 40 may be folded against the side surface of the electrode lead wire 3 within the delivery sheath (e.g., the second needle 13), or may be received in a recess 41 (or opening 41) formed in the delivery sheath (e.g., the second needle 13).

[0108] The example in FIG. 15 is similar to the example in FIG. 13, and the misalignment prevention member 32 includes an elastically biased hook 44 attached to the electrode lead wire 3. In this example, the misalignment prevention member 32 includes two elastically biased hooks 44 attached to the electrode lead wire 3 by a collar 45. The misalignment prevention member 32 is received in a recess 46 (or opening 46) formed in the delivery sheath (e.g., the second needle 13) as shown.

[0109] In some examples, the elastically biased hook 44 may be provided additionally or alternatively on the housing portion 2 of the medical implant 1. In some examples, the elastically biased hook 44 may be provided on the housing portion of the medical implant 1 in FIG. 3B. In some examples, the elastically biased hook 44 may be provided on the housing portion 2, the wire 77, or the wireless power transmitter 75 of the medical implant 1 in FIG. 3C.

[0110] In the example of FIG. 16, the medical implant 1 (in particular, the electrode lead wire 3) is provided with a misalignment prevention member 32. In this example, the misalignment prevention member 32 is an elastically biased sharp tooth portion (tongue-like portion or branch-like portion) 42 formed from the outer layer of the electrode lead wire 3. In particular, the electrode lead wire 3 has an outer layer, and the elastically biased tooth portion 42 is formed by making a U-shaped cut in the outer layer. Thereby, the tooth portion 42 can be elastically deformed outward. As shown in the figure, when the elastically biased tooth portion 42 is deployed, a recess 43 remains in the outer layer of the electrode lead wire 3. Therefore, when the electrode lead wire 3 is accommodated in a delivery sheath (for example, the second needle 13 shown in FIG. 4), the elastically biased tooth portion 42 is held within the recess 43. In the illustrated example, a plurality (for example, four) of elastically biased tooth portions 42 are provided. The plurality of elastically biased tooth portions 42 are arranged at intervals along the length of the electrode lead wire 3, but additionally or alternatively, they may be arranged radially at intervals in the circumferential direction of the electrode lead wire 3. Therefore, during implantation, the elastically biased tooth portion 42 moves outward and functions to prevent the electrode lead wire 3 from moving.

[0111] In some examples, the outer layer of the electrode lead wire 3 (and the elastically biased tooth portion 42) may be made of metal (for example, steel) or a biocompatible polymer.

[0112] In some examples, the elastically biased tooth portion 42 may be provided additionally or alternatively on the housing portion 2 of the medical implant 1. In some examples, the elastically biased tooth portion 42 may be provided on the housing portion of the medical implant 1 in FIG. 3B. In some examples, the elastically biased tooth portion 42 may be provided on the housing portion 2, the wire 77, or the wireless power supply transmitter 75 of the medical implant 1 in FIG. 3C.

[0113] In the examples of FIGS. 17A and 17B, the medical implant 1 includes one or more anti-displacement members 32. In this example, the anti-displacement member 32 includes a plurality of elastically biased hooks 44 formed at the end of the electrode lead wire 3 and / or at the end of the housing portion 2 on the side opposite to the electrode lead wire 3. Examples in which hooks 44 are formed at both of these ends are shown in FIGS. 17A and 17B. As shown in the figure, a plurality of elastically biased hooks 44 are formed at the end of the medical implant 1. The plurality of hooks 44 have different directions from each other so as to extend radially at intervals with respect to the medical implant 1. The plurality of elastically biased hooks 44 have elasticity (restoring force) and are biased toward the curved position (bent position) as shown in FIG. 17A, and at this position, they act to fix the medical implant 1 to the patient's tissue.

[0114] As shown in the upper figure of FIG. 17B, before implantation (deployment), the plurality of elastically biased hooks 44 are accommodated in a deformed state (i.e., a straight state) within a delivery sheath (e.g., the second needle 13). When the medical implant 1 is implanted (deployed), as shown in the lower figure of FIG. 17B, the plurality of elastically biased hooks 44 return to the biased position.

[0115] Advantageously, by disposing the anti-displacement member 32 at the end of the medical implant 1, an increase in the diameter of the medical implant 1 and the associated delivery device can be avoided. Furthermore, by providing the anti-displacement member 32 on both the electrode lead wire 3 and the housing portion 2, both ends of the medical implant 1 are fixed, so that the fixity can be improved.

[0116] In some examples, the anti-displacement member 32 may be provided on the housing portion 2 (e.g., both ends of the housing portion 2) of the medical implant 1 in FIG. 3B. In some examples, the anti-displacement member 32 may be provided on one or more of the housing portion 2, the wire 77, or the wireless power supply transmitter 75 of the medical implant 1 in FIG. 3C.

[0117] In the example of FIG. 18, the medical implant 1 (particularly, the electrode lead wire 3) includes a misalignment prevention member 32. In this example, the misalignment prevention member 32 is an elastically biased frame 45. The elastically biased frame 45 has a folded form that can be accommodated within a delivery sheath (e.g., a second needle 13 as shown in FIG. 4) and a deployed form (expanded form) shown in FIG. 18. The elastically biased frame 45 is biased toward the deployed form (expanded form). The elastically biased frame 45 may be made of a polymer or metal, and preferably may be made of a memory material such as nitinol.

[0118] Therefore, when the medical implant 1 is implanted (deployed), the elastically biased frame 45 deploys (expands) into the deployed form (expanded form) to fix the medical implant 1. As shown in the figure, the elastically biased frame 45 is provided on the electrode lead wire 3 and may be attached to the electrode lead wire 3 by a collar or clamp or the like. The elastically biased frame 45 is disposed between the housing portion 2 and the electrode 4. Thereby, the delivery sheath (e.g., a second needle 13 as shown in FIG. 4) can be partially retracted to expose the electrode 4 without the elastically biased frame 45 being deployed. Therefore, the position of the electrode 4 can be inspected before the misalignment prevention member 32 is deployed (expanded). In an alternative example, the misalignment prevention member 32 may be provided on the housing portion 2 instead of or in addition to the electrode lead wire 3.

[0119] In some examples, the misalignment prevention member 32 may be provided on the housing portion 2 of the medical implant 1 of FIG. 3B. In some examples, the misalignment prevention member 32 may be provided on one or more of the housing portion 2, the wire 77, or the wireless power supply transmitter 75 of the medical implant 1 of FIG. 3C.

[0120] In the example of FIG. 19, the medical implant 1 (particularly, the electrode lead wire 3) includes a displacement prevention member 32. In this example, the displacement prevention member 32 is an elastically biased stent 46. The elastically biased stent 46 has a contracted form that can be accommodated within a delivery sheath (e.g., a second needle 13 as shown in FIG. 4) and an expanded form as shown in FIG. 19. The elastically biased stent 46 is biased toward the expanded form. The elastically biased stent 46 may include one or more struts and / or rings in a conventional manner (e.g., a vascular stent). The elastically biased stent 46 may be made of a biocompatible polymer or metal, and preferably may be made of a memory material such as nitinol.

[0121] Accordingly, when the medical implant 1 is implanted (deployed), the elastically biased stent 46 expands to the expanded form to fix the medical implant 1. As shown, the elastically biased stent 46 is provided on the electrode lead wire 3 and may be attached to the electrode lead wire 3 by a collar or the like. The elastically biased stent 46 is disposed between the housing portion 2 and the electrode 4. Thereby, the delivery sheath (e.g., a second needle 13 as shown in FIG. 4) can be partially retracted to expose the electrode 4 without the elastically biased stent 46 being deployed (expanded). Accordingly, the position of the electrode 4 can be inspected before the displacement prevention member 32 is deployed (expanded). In an alternative example, the displacement prevention member 32 may be provided on the housing portion 2 instead of or in addition to the electrode lead wire 3.

[0122] In some examples, the displacement prevention member 32 may be provided on the housing portion 2 of the medical implant 1 of FIG. 3B. In some examples, the displacement prevention member 32 may be provided on one or more of the housing portion 2, the wire 77, or the wireless power supply transmitter 75 of the medical implant 1 of FIG. 3C.

[0123] In the example of FIG. 20, the medical implant 1 (particularly, the electrode lead wire 3) includes a displacement prevention member 32. In this example, the displacement prevention member 32 is an elastically biased coil 47. The elastically biased coil 47 has a contracted form that can be accommodated within a delivery sheath (e.g., a second needle 13 as shown in FIG. 4) and an expanded form as shown in FIG. 20. The elastically biased coil 47 is biased toward the expanded form. The elastically biased coil 47 may be made of a biocompatible polymer or metal, and preferably may also be made of a memory material such as nitinol.

[0124] Therefore, when the medical implant 1 is implanted (deployed), the elastically biased coil 47 expands to the expanded form to fix the medical implant 1. As shown in the figure, the elastically biased coil 47 is provided on the electrode lead wire 3 and may be attached to the electrode lead wire 3 by a collar or a clamp or the like.

[0125] In the illustrated example, the elastically biased coil 47 is disposed at the end of the electrode lead wire 3. In other examples, the elastically biased coil 47 may be disposed between the housing portion 2 and the electrode 4. Thereby, without the elastically biased coil 47 being deployed, the delivery sheath (e.g., a second needle 13 as shown in FIG. 4) can be partially retracted to expose the electrode 4. Therefore, the position of the electrode 4 can be inspected before the displacement prevention member 32 is deployed (expanded). In an alternative example, the displacement prevention member 32 may be provided on the housing portion 2 instead of or in addition to the electrode lead wire 3.

[0126] In some examples, the displacement prevention member 32 may be provided on the housing portion 2 of the medical implant 1 in FIG. 3B (e.g., both ends of the housing portion 2). In some examples, the displacement prevention member 32 may be provided on one or more of the housing portion 2, the wire 77, or the wireless power supply transmitter 75 of the medical implant 1 in FIG. 3C.

[0127] The example of FIG. 21 is similar to the example of FIG. 20, and the misalignment prevention member 32 includes an elastically biased coil 47. However, in the example of FIG. 21, the misalignment prevention member 32 further includes an elastically biased second coil 48 attached to the elastically biased coil 47. The elastically biased second coil 48 is formed in the same manner as the coil 47 and is connected to the coil 47 via a straight portion. The elastically biased second coil 48 enhances the fixity of the medical implant 1.

[0128] In the example of FIG. 22, the medical implant 1 (particularly, the electrode lead wire 3) includes a displacement prevention member 32. In this example, the displacement prevention member 32 is a shape memory member 49 that extends through the electrode lead wire 3. Specifically, as shown in FIG. 22B, the shape memory member 49 is embedded in the electrode lead wire 3. The shape memory member 49 may be provided along a conductor (wire) 50 in the electrode lead wire 3 or between a plurality of conductors (wires) 50. The shape memory member 49 may extend over the entire length of the electrode lead wire 3, may partially extend along the electrode lead wire 3, or may be provided in a plurality of portions spaced apart along the electrode lead wire 3 (intermittently). The shape memory member 49 may be made of a polymer or metal, and particularly may be made of a shape memory material such as nitinol. The shape memory member 49 has a non-linear (e.g., wavy as shown) shape. Thus, when not constrained, the electrode lead wire 3 assumes a non-linear shape and acts to fix the electrode lead wire 3 within the patient's tissue. When the electrode lead wire 3 is constrained within a delivery sheath (e.g., a second needle 13 as shown in FIG. 4), the shape memory member 49 is deformed to be linear. Thus, when the medical implant 1 is implanted (deployed), the shape memory member 49 deforms the electrode lead wire 3 into a non-linear shape to fix the medical implant 1. The shape memory member 49 allows the delivery sheath (e.g., a second needle 13 as shown in FIG. 4) to be partially withdrawn so as to expose the electrode 4. Also, the delivery sheath (e.g., a second needle 13 as shown in FIG. 4) can be extended again to reposition the electrode lead wire 3. Thus, the position of the electrode 4 can be inspected before the electrode lead wire 3 is fully implanted (deployed).

[0129] In some examples, the shape memory member 49 may be provided within the wire 77 of the medical implant 1 of FIG. 3C.

[0130] As described above, the medical implant 1 includes one or more anti-displacement members 32 that act to reduce the movement of the medical implant 1 after implantation. Referring to FIGS. 4-9, in some examples, the medical implant 1 is housed within the delivery device 10, and the electrode lead wire 3 includes one or more anti-displacement members 32. In such examples, the anti-displacement member 32 may be misaligned with respect to a slot (opening 18) formed in the second needle 13. In particular, the second needle 13 may have a holding portion that acts to hold the electrode lead wire 3 and hold the anti-displacement member 32.

[0131] In the example of FIG. 23, the medical implant 1 (particularly, the electrode lead wire 3) includes an anti-displacement member 32. In this example, the anti-displacement member 32 is a high-friction region 51 formed on the surface of the electrode lead wire 3. The high-friction region 51 may include a coating or a color. The high-friction region 51 may have a relatively high surface roughness formed, for example, by grooves. Thereby, the high-friction region 51 can help prevent the movement of the electrode lead wire 3 relative to the patient's tissue after the medical implant 1 is implanted. The electrode lead wire 3 may include a plurality (e.g., two as shown in the figure) of high-friction regions 51 spaced along the length of the electrode lead wire 3.

[0132] In the illustrated example, the high-friction region 51 is disposed between the housing portion 2 and the electrode 4. Thereby, the delivery sheath (e.g., the second needle 13 as shown in FIG. 4) can be partially retracted to expose the electrode 4 without exposing the high-friction region 51. Thus, the position of the electrode 4 can be inspected before the electrode lead wire 3 is fully implanted (deployed). In an alternative example, the anti-displacement member 32 may be provided on the housing portion 2 instead of or in addition to the electrode lead wire 3.

[0133] In some examples, the high friction region 51 may be provided on the housing portion 2 of the medical implant 1 of FIG. 3B. In some examples, the high friction region 51 may be provided on one or more of the housing portion 2, the wire 77, or the wireless power transmitter 75 of the medical implant 1 of FIG. 3C.

[0134] In the example of FIG. 24, the medical implant 1 (particularly, the electrode lead wire 3) includes a misalignment prevention member 32. In this example, the misalignment prevention member 32 is similar to that of FIG. 12 and is disposed on the electrode lead wire 3 such that the first set of teeth 36 and the second set of teeth 37 face in opposite directions. The teeth 36, 37 are elastically biased. In this example, as described above, the misalignment prevention member 32 is disposed such that the electrode 4 is disposed between the misalignment prevention member 32 and the distal end 35. In this example, the width of the teeth 36, 37 is wider than the opening (slot) 18 of the second needle 13. Thus, the teeth 36, 37 are held against the electrode lead wire 3 within the second needle 13 and will not be deployed even if aligned with the opening 18. When the second needle 13 is retracted as described above, the teeth 36, 37 spring outward to fix the electrode lead wire 3 to the patient's tissue. Since the electrode 4 is disposed between the distal end 35 of the electrode lead wire 3 and the misalignment prevention member 32, the second needle 13 can be partially retracted to expose the electrode 4, similar to the above example. This enables, for example, inspection of the implantation position of the electrode 4 without deploying the misalignment prevention member 32. Thus, if necessary, the second needle 13 can be deployed again and the electrode lead wire 3 can be repositioned.

[0135] FIG. 26 shows an end view of the medical implant 1 of the example of FIG. 25. In this example, the medical implant 1 (particularly, the electrode lead wire 3) includes a misalignment prevention member 32. In this example, the misalignment prevention member 32 includes a plurality of elastically biased teeth 53 disposed on one side of the electrode lead wire 3. The plurality of elastically biased teeth 53 are arranged so as not to be aligned with the opening 18 of the second needle 13 when the electrode lead wire 3 is held within the second needle 13. In particular, as shown in FIG. 26, the plurality of elastically biased teeth 53 are arranged so as to all fit within an angular range of about 180 degrees or less and extend from the electrode lead wire 3. When the electrode lead wire 3 is held by the second needle 13, none of the teeth 53 are aligned with the opening 18, whereby in the retracted state, all of the teeth 53 are held with respect to the electrode lead wire 3. In some examples, the plurality of teeth 53 may be attached to the electrode lead wire 3 in an angular range greater than or less than about 180 degrees. In particular, the plurality of teeth 53 may be attached to the electrode lead wire 3 in an angular range smaller than the size of the opening 18. When the second needle 13 is retracted as described above, the teeth 53 bounce outward to fix the electrode lead wire 3 to the patient's tissue. Similar to the above example, the second needle 13 may be partially retracted to expose the electrode 4 without deploying the misalignment prevention member 32, for example, to inspect the implantation position of the electrode 4. Thus, if necessary, the second needle 13 may be redeployed and the electrode lead wire 3 may be repositioned.

[0136] In the example of FIG. 27, the misalignment prevention member 32 is similar to those of FIGS. 25 and 26, and the plurality of elastically biased teeth 53 are arranged so as not to be aligned with the opening 18 of the second needle 13 when the electrode lead wire 3 is held within the second needle 13. In this example, the plurality of teeth 53 are divided into a plurality of groups 54a - 54d and each group 54a - 54d is disposed between adjacent electrodes 4.

[0137] The example of FIG. 28 combines the examples of FIGS. 24 and 27. In particular, the electrode lead wire 3 of the medical implant 1 includes a misalignment prevention member 32, and the misalignment prevention member 32 includes a first set of teeth 36 and a second set of teeth 37 arranged on the electrode lead wire 3 so as to face in opposite directions, and a group 54a to 54d of teeth 53 interposed between adjacent electrodes 4.

[0138] FIGS. 29 to 31 show respective examples of the misalignment prevention member 32 that can be attached to the electrode lead wire 3 of the medical implant 1. The misalignment prevention member 32 can be attached to the electrode lead wire 3, for example, slidably, by friction fitting, adhesion, or welding. In other examples, the misalignment prevention member 32 may be overmolded on the electrode lead wire 3.

[0139] In the example of FIG. 29, the misalignment prevention member 32 includes a sleeve portion 55 slidable on the electrode lead wire 3, or a sleeve portion 55 overmolded on the electrode lead wire 3. A plurality of elastically biased teeth 56 extend from the sleeve portion 55 (particularly, the end of the sleeve portion 55). The elastically biased teeth 56 have a wavy (non-linear) shape to improve anchor fixation.

[0140] The example of FIG. 30 is the same as the example of FIG. 29 except that the elastically biased teeth 57 have openings 58. The openings 58 can help in the long-term fixation of the electrode lead wire 3 by allowing tissue growth to pass through the openings 58. In some examples, each elastically biased tooth 57 may have a single opening 58 or a plurality of openings 58. The openings 58 may be circular, square, rectangular, or other shapes.

[0141] Furthermore, in the example of FIG. 30, the width of the elastically biased tooth portion 57 is narrow at the portion attached to the sleeve portion 55 and wide at the free end. The maximum width of the elastically biased tooth portion 57 (at the free end) is larger than the width of the opening 18, thereby preventing the tooth portion 57 from being deployed before the second needle is retracted. The edge of the tooth portion 57 extending between both ends of the tooth portion 57 may be linear as shown in the figure, or may be non-linear (for example, curved or wavy). Therefore, the width of the tooth portion 57 may change at a non-constant rate between both ends of the tooth portion 57. The plurality of elastically biased tooth portions 57 are spaced apart from each other in the sleeve portion 55. Thereby, there is a space between the plurality of elastically biased tooth portions 57 for the tooth portion 57 to be folded inward when the tooth portion 57 is received in the second needle 13. In this example, the elastically biased tooth portion 57 is curved so as to bulge radially outward. The curvature of the tooth portion 57 matches the outer diameter of the electrode lead wire 3. Thereby, when the tooth portion 57 is pressed against the electrode lead wire 3, the tooth portion 57 can be fitted so as to be in close contact with the electrode lead wire 3.

[0142] The example of FIG. 31 is the same as the example of FIG. 29 except that the elastically biased tooth portion 59 extends from the side surface of the sleeve portion 55 instead of the end portion of the sleeve portion 55.

[0143] In any of the above examples, the displacement prevention member 32 includes an opening 58 as shown in FIG. 30 or is porous, whereby the growth of tissue is allowed, improving the fixity of the electrode lead wire 3.

[0144] It will be understood that in various examples, any of the above displacement prevention members 32 may be attached to the electrode lead wire 3 using a sleeve portion 55 as shown in FIGS. 29 to 31. The sleeve portion 55 may be provided slidably on the electrode lead wire 3. The sleeve portion 55 may be fixed to the electrode lead wire 3 by adhesion, welding, crimping, or friction fitting. In some examples, the sleeve portion 55 (and the displacement prevention member 32) may be overmolded on the electrode lead wire 3.

[0145] In the examples of FIGS. 10 to 29 above, it may be advantageous to prevent rotation of the electrode lead wire 3 within the second needle 13 before retraction of the second needle 13 (for example, preventing the alignment prevention member 32 from being aligned with the opening 18 of the second needle 13). FIGS. 32 and 33 show examples of the second needle 13 and the electrode lead wire 3 provided with a rotation prevention mechanism for realizing this.

[0146] In the example of FIG. 32, the electrode lead wire 3 has two flat portions 61, and the two flat portions 61 of the electrode lead wire 3 are arranged so as to contact the two flat surfaces 60 of the second needle 13. In this example, the flat surfaces 60 of the second needle 13 are arranged at the edge portions on both sides of the opening 18. By the contact between the flat surface 60 and the flat portion 61, rotation of the electrode lead wire 3 within the second needle 13 is prevented, thereby preventing the alignment between the alignment prevention member 32 and the opening 18. The flat portion 61 and the flat surface 60 may extend along the entire length along the electrode lead wire 3 and the second needle 13, or may extend only along a part of the electrode lead wire 3 and the second needle 13. In some examples, the flat portion 61 extends only partially along the electrode lead wire 3 in the region corresponding to the alignment prevention member 32.

[0147] In the example of FIG. 33, the second needle 13 includes protrusions 63a and 63b extending from the side surface of the electrode lead wire 3. The protrusions 63a and 63b may have an elongated shape extending partially or along the entire length along the length of the electrode lead wire 3, or may not be in an elongated shape, for example, may be in a boss shape. Preferably, the protrusions 63a and 63b are aligned with the alignment prevention member 32 (at least) on the electrode lead wire 3. The protrusions 63a and 63b are received in slots 62a and 62b formed on the inner surface of the second needle 13. The slots 62a and 62b and the protrusions 63a and 63b cooperate to prevent rotation of the electrode lead wire 3 within the second needle 13.

[0148] Figures 34 and 35 show another example of the electrode lead wire 3 including the misalignment prevention member 32. In these examples, the misalignment prevention member 32 is formed at the distal end 35 of the electrode lead wire 3. The misalignment prevention member 32 includes a raised portion 64 having a plurality of circumferential protrusions. The circumferential protrusions may be a plurality of ridges separated from each other or may be spiral. The circumferential protrusions of the raised portion 64 may be inclined (angled) or tapered as shown in the figure, for example, may have a tapered surface facing the distal end 35 and a flat surface facing another direction. Thereby, the anchor effect of the misalignment prevention member 32 can be improved.

[0149] When the electrode lead wire 3 is embedded, the raised portion 64 can function to prevent the electrode lead wire 3 from being pulled out from the patient's tissue. After embedding, as tissue grows (heals) between the raised portions 64, the electrode lead wire 3 can be further fixed in the patient's tissue. In the example of FIG. 34, the raised portion 64 is generally cylindrical, and in the example of FIG. 35, the raised portion 64 tapers toward the distal end 35.

[0150] In the illustrated example, the raised portion 64 is disposed at the distal end 35 of the electrode lead wire 3. In other examples, one or more raised portions 64 may be provided, and the raised portions 64 may be additionally or alternatively disposed between the plurality of electrodes 4 on the electrode lead wire 3.

[0151] It will be understood that the raised portion 64 can be combined with any of the misalignment prevention members in the other examples described above.

[0152] Throughout the description and claims of this specification, terms such as "comprising," "having," "including" are intended to mean "comprising (having, including) without limitation," and are not intended to exclude other components, integer values, or steps. Throughout the description and claims of this specification, unless specifically required by the context, the singular form shall include the plural. In particular, when an indefinite article is used, unless otherwise specified by the context, this specification is understood to assume not only the singular but also the plural.

[0153] Features, integer values, characteristics, or groups described in connection with a particular aspect, embodiment, or example of the present invention are to be understood as applicable to other aspects, embodiments, or examples described herein, unless inconsistent therewith. All features disclosed in this specification (including the appended claims, abstract, and drawings), and / or all steps of any methods or processes, may be combined in any combination, except combinations where at least some of the features and / or steps are mutually exclusive. The invention is not limited to the details of the above-described embodiments. The invention extends to any novel and inventive feature or combination of features disclosed in this specification (including the appended claims, abstract, and drawings), or any novel and inventive step or combination of steps of any methods or processes.

Claims

1. A nerve implant system for the percutaneous delivery of a nerve implant to a patient's tissue, comprising a nerve implant having a housing portion and an elongated electrode lead wire, a delivery device having a handle, a first needle, and a second needle, wherein the first needle is fixed to the handle, the lumen of the first needle is configured to accommodate the housing portion of the nerve implant, the gauge of the second needle is larger than the gauge of the first needle, the second needle comprises a holding portion that partially surrounds the electrode lead wire and an open side surface that extends at least partially along the length of the second needle, the second needle is retractable to place the electrode lead wire in the patient's tissue, the electrode lead wire comprises an elastically biased misalignment prevention member, the misalignment prevention member is aligned with the holding portion of the second needle so as to be constrained prior to deployment, the misalignment prevention member is configured to move to a deployed position after retraction of the second needle, A nerve implant system.

2. The holding portion of the second needle comprises a wall portion having a recess configured to receive the misalignment prevention member, The nerve implant system according to claim 1.

3. The recess is an opening that penetrates the wall portion of the holding portion, The nerve implant system according to claim 2.

4. The electrode lead wire comprises a plurality of the misalignment prevention members, The nerve implant system according to any one of claims 1 to 3.

5. The delivery device comprises a pusher operable to extrude the housing portion from the first needle, The nerve implant system according to any one of claims 1 to 4.

6. One or more elastically biased misalignment prevention members are also provided on the housing portion of the nerve implant, The nerve implant system according to any one of claims 1 to 5.

7. The first needle comprises a wall portion having a recess configured to receive the misalignment prevention member of the housing portion, The nerve implant system according to claim 6.

8. The electrode lead wire comprises an electrode, The misalignment prevention member of the electrode lead wire is disposed between the electrode and the housing portion, The nerve implant system according to any one of claims 1 to 7.

9. The misalignment prevention member includes fins. The nerve implant system according to any one of claims 1 to 8.

10. The fins can be folded with respect to the nerve implant. The nerve implant system according to claim 9.

11. The fins are shaped so as to be angled toward the user's skin when implanted. The nerve implant system according to claim 9 or claim 10.

12. The misalignment prevention member includes sharp teeth. The nerve implant system according to any one of claims 1 to 8.

13. The misalignment prevention member includes a plurality of the teeth. The nerve implant system according to claim 12.

14. The plurality of teeth includes a first tooth portion and a second tooth portion. The first tooth portion is directed in a direction opposite to that of the second tooth portion. The nerve implant system according to claim 13.

15. The misalignment prevention member includes a hook. The nerve implant system according to any one of claims 1 to 8.

16. The hook includes a shape memory material such as a shape memory alloy like nitinol or a shape memory polymer. The nerve implant system according to claim 15.

17. The hook is provided so as to be directed toward the housing portion. The nerve implant system according to claim 15 or claim 16.

18. The misalignment prevention member includes a stent. The nerve implant system according to any one of claims 1 to 8.

19. The stent includes a foldable frame elastically biased to an expanded position. The nerve implant system according to claim 18.

20. The misalignment prevention member includes a coil. The nerve implant system according to any one of claims 1 to 8.

21. The misalignment prevention member is disposed at or around the distal end of the electrode lead wire. The nerve implant system according to any one of claims 9 to 20.

22. The misalignment prevention member includes a shape memory member embedded in the electrode lead wire. The nerve implant system according to any one of claims 1 to 21.

23. The shape memory member is elastically biased in a non-linear shape, the second needle holds the electrode lead wire in a linear shape before retraction of the second needle, The nerve implant system according to claim 22.

24. The second needle includes an opening extending longitudinally along one side surface of the second needle, the misalignment prevention member includes an elastically biased sharp tooth portion disposed on the electrode lead wire, the width of the tooth portion is larger than the width of the opening of the second needle, The nerve implant system according to any one of claims 1 to 8.

25. The tooth portion has a first end attached to the electrode lead wire and a second end that is a free end, the width of the tooth portion at the second end is larger than the width of the tooth portion at the first end, The nerve implant system according to claim 24.

26. The tooth portion is curved, The nerve implant system according to claim 24 or claim 25.

27. The second needle includes an opening extending longitudinally along one side surface of the second needle, the misalignment prevention member includes an elastically biased sharp tooth portion disposed on the electrode lead wire, the tooth portion is arranged so as not to be aligned with the opening of the second needle, The nerve implant system according to any one of claims 1 to 8 and any one of claims 24 to 26.

28. The misalignment prevention member includes a sleeve portion surrounding a part of the electrode lead wire so as to fix the misalignment prevention member to the electrode lead wire, The nerve implant system according to any one of claims 1 to 27.

29. The second needle and the electrode lead wire are provided with an anti-rotation mechanism, The nerve implant system according to any one of claims 1 to 28.

30. The electrode lead wire further includes one or more raised portions, The nerve implant system according to any one of claims 1 to 29.

31. A method for percutaneously delivering a nerve implant into a patient's tissue, comprising: providing the nerve implant system according to any one of claims 1 to 30; percutaneously placing the second needle into the patient's tissue at a desired anatomical location; The step of retracting the second needle so as to release the electrode lead wire into the tissue; The step of placing the displacement prevention member; A method comprising the above.

32. A medical implant that is percutaneously implanted into a patient's tissue by a delivery device, Comprising an elastically biased displacement prevention member, The displacement prevention member is configured to be movable from a retracted position in which the medical implant is accommodated in the delivery device to a deployed position in which the medical implant is released from the delivery device. Medical implant.

33. Further comprising a housing portion and an elongated electrode lead wire extending from the housing portion, The medical implant according to claim 32.

34. The displacement prevention member is provided on the electrode lead wire and / or the housing portion, The medical implant according to claim 33.

35. The displacement prevention member is, Fins protruding from the medical implant, Sharp teeth protruding from the medical implant, Hooks protruding from the medical implant, A stent protruding from the medical implant, Including one or more of the above, The medical implant according to any one of claims 32 to 34.

36. A delivery device for percutaneously implanting a nerve implant into a patient's tissue, The nerve implant has a housing portion and an electrode lead wire extending from the housing portion, The delivery device is, A handle, A first needle fixed to the handle, the first needle having a lumen configured to accommodate the housing portion of the nerve implant, A second needle having a larger gauge than the first needle, the second needle having a holding portion that partially surrounds the electrode lead wire and an open side surface that extends at least partially along the length of the second needle, and the second needle being retractable so as to place the electrode lead wire in the patient's tissue. The holding portion has a recess for accommodating an elastically biased displacement prevention member in the nerve implant within the second needle. Delivery device.

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