Implant delivery devices

Abstract

The present application provides an implant delivery device (10) for implanting a medical implant (1) in a patient. The medical implant (1) includes an implant housing (2) and an elongated electrode lead (3) extending from the implant housing. The implant delivery device (10) includes a handle (11), a first needle (12), and a second needle (13). The first needle (12) is fixed relative to the handle (11) and extends longitudinally. The first needle (12) includes a lumen configured to receive the implant housing (2) of the medical implant (1). The second needle (13) has a larger gauge than the first needle (12) and is configured to carry the elongated electrode lead (3) of the medical implant (1). The second needle (13) is retractably mounted relative to the handle (11) so as to be movable between an extended position in which the second needle (13) extends longitudinally beyond the first needle (12) so that during use the first needle (12) and the second needle (13) can simultaneously position the implant housing (2) at a first depth and the electrode lead wire (3) at a second depth deeper than the first depth, and a retracted position in which the second needle (13) is retracted toward the handle (11) to release the electrode lead wire (3) from the second needle (13).

Description

Technical Field

[0001] The present invention relates to an implant delivery device for implanting a medical implant, such as a neuromodulation implant, into a patient.

Background Art

[0002] The provision of an implantable nerve stimulation device having a housing and electrodes is known. A power antenna, a microcontroller, and a communication antenna are disposed within the housing for receiving power from an external source and transmitting and receiving sensor information related to the electrodes. A delivery system can be used to position a nerve stimulation device, among other things, in the vicinity of a nerve within a patient by cutting and forming an opening in the patient and feeding the delivery system into this opening to position the implantable nerve stimulation device.

Summary of the Invention

Means for Solving the Problems

[0003] According to the present disclosure, there is provided an implant delivery device for implanting a medical implant comprising an implant housing and an elongate electrode lead extending from the implant housing into a patient. The implant delivery device includes a handle, a first needle fixed to the handle and extending in a longitudinal direction, the first needle comprising a lumen configured to receive the implant housing of the medical implant, a second needle having a larger gauge than the first needle, the second needle being configured to carry the elongate electrode lead of the medical implant, the second needle being in an extended position, in which the second needle extends beyond the first needle in the longitudinal direction such that during use the first needle and the second needle can simultaneously position the implant housing at a first depth and the electrode lead at a second depth deeper than the first depth, The second needle is retracted toward the handle to release the electrode lead wire from the second needle, in a retracted position, A second needle is mounted retractably relative to the handle so as to be movable between the two, It is equipped with.

[0004] In some examples, the first and second needles each have a sharp tip, such as a beveled tip, configured to puncture the skin and penetrate the patient's tissue during use in order to position the first and second needles for electrode release. In some examples, the first needle is configured solely for the purpose of penetrating the skin and underlying adipose tissue during use. Thus, a relatively large first needle will only penetrate the patient to the minimum required depth, reducing tissue damage.

[0005] In some examples, the second needle has a lumen configured to receive an elongated electrode lead wire of a medical implant. In some examples, the second needle has a slot that extends along one side and extends into the lumen. This slot may extend to the tip of the second needle. This slot may extend from the tip of the second needle into the lumen of the first needle when the second needle is in the extended position. In some examples, the first and second needles are arranged non-concentrically so that a portion of the electrode lead wire extends from the lumen of the second needle through the slot to the implant housing during use.

[0006] In some examples, the second needle has a mounting point located at or near its distal end, which is configured to mount an elongated electrode lead wire so that the elongated electrode lead wire is carried along one side of the second needle. For example, the mounting point may have a hole configured to receive the end of the elongated electrode lead wire. This hole may be formed in the distal end of the second needle or in the side of the second needle near this distal end.

[0007] In some examples, the second needle is at least partially located within the lumen of the first needle. For example, the second needle extends parallel to the implant housing within the lumen of the first needle. In some examples, the lumen of the first needle may comprise a primary portion configured to receive the implant housing and a secondary portion configured to receive the second needle, each of which may have a partially circular cross-section. The first needle may have a teardrop-shaped cross-sectional profile, and the cross-sectional areas of the primary and secondary portions are substantially circular and configured to partially overlap.

[0008] In some cases, the implant housing is positioned within the lumen of the first needle so that it can be pulled out of the lumen of the first needle. Therefore, the retaining force generated between the electrode lead and the patient's tissue after the electrode lead is released will pull the implant housing out of the lumen of the first needle when the implant delivery device is removed from the patient.

[0009] In some examples, the implant delivery device further comprises a retaining member configured to releasably secure the implant housing within the lumen of a first needle. This retaining member may be operable by an operator to release the implant housing and allow it to exit the first needle and move into a deployed position in the patient.

[0010] In some examples, the retaining member may include retaining tabs, which are formed in the wall of the first needle and configured to engage the implant housing within the lumen of the first needle. The retaining tabs may be formed by a U-shaped notch in the first needle that is partially deformed into the lumen of the first needle. The implant housing may include recesses configured to correspond to the retaining tabs. The first needle may have a plurality of retaining tabs, which are distributed longitudinally and / or circumferentially around the first needle and configured to engage with the implant housing.

[0011] In some examples, the implant housing may have mounting points, such as holes. The retaining member may extend from a portion of the handle to the mounting point of the implant housing, and the retaining member may be removable to release the implant housing.

[0012] In some examples, the retaining member may include a thread that penetrates the mounting point of the implant housing and forms a loop, which can be separated by the operator, for example, by being cut or unraveled to release the implant housing. In some examples, the thread may consist of sutures made of, for example, nylon, Monocryl, Vicryl, silk, or Prolene, or metal wire such as steel wire, or other materials such as Kevlar.

[0013] In some examples, the retaining member may consist of a shape memory member, which may have a hook end configured to engage with a mounting point on the implant housing. The opposing end of the shape memory member may be configured to move to deform the hook end in order to release the implant housing. The opposing end of the shape memory member may be mounted on a sliding tab configured to be slid by an operator to deform the hook end.

[0014] In some examples, the retaining member includes a clamping cap configured to press-fit onto the end of the implant housing. The implant delivery device may further include a spring-loaded release mechanism that can operate to separate the clamping cap from the implant housing.

[0015] In some examples, the implant delivery device may further include an actuation tab positioned adjacent to the handle. This actuation tab may be attached to or part of the second needle. Alternatively, the actuation tab may be operably coupled to the second needle. The actuation tab may be configured to be actuated by the user to move the second needle to a retracted position. In some examples, the actuation tab may be movable away from the handle and away from the patient to move the second needle to a retracted position. In other examples, the actuation tab may be movable towards the handle and towards the patient to move the second needle to a retracted position.

[0016] In some examples, the implant delivery device may further include a locking mechanism configured to lock a second needle in an extended position. The locking mechanism may directly lock the second needle in an extended position, or it may lock an actuation tab so that the second needle is locked in an extended position.

[0017] In some examples, the implant delivery device includes a locking slot within the handle. The second needle may be configured to engage with the locking slot such that, in one rotational position of the second needle relative to the handle, the second needle is axially locked relative to the handle, and in another rotational position of the second needle relative to the handle, the second needle is axially movable relative to the handle. In some examples, the locking slot may consist of an L-shaped or J-shaped slot. In some examples, the handle may include a locking ring, and the locking slot may be formed within the locking ring.

[0018] In some examples, the actuating tab is movable in a first direction, thereby moving the second needle in a second direction opposite to the first direction. The implant delivery device may further include a rack and pinion mechanism operably coupled between the actuating tab and the second needle.

[0019] In some examples, the handle may include a guide member, and the actuating tab may be movable along the guide member. A locking mechanism may be configured to lock the actuating tab in a certain position along the guide member. This locking mechanism may include a button configured to release the locking mechanism in order to move the actuating tab along the guide member.

[0020] In some examples, the implant delivery device may further include a retaining member configured to releasably secure the implant housing within the lumen of a first needle, the retaining member being actuated by an actuating tab to release the implant housing. In some examples, the second needle is moved to a retracted position by the actuating tab moving in a first direction over a first distance, and the retaining member is actuated to release the implant housing by the actuating tab moving further in the first direction over a second distance. In some examples, the retaining member includes a clamping cap configured to press-fit onto the implant housing, and the implant delivery device may further include a spring-loaded release mechanism that is actuated by the actuating tab to separate the clamping cap from the implant housing. Specifically, the spring-loaded release mechanism may be actuated by the actuating tab moving over a second distance to separate the clamping cap from the implant housing. For example, a catch on the spring-loaded release mechanism may be released by the actuating tab moving over a second distance.

[0021] In some examples, the implant delivery device may further include an implant deployment member comprising a pusher extending from near the handle into the lumen of the first needle. The implant deployment member may be slidable relative to the first needle to push the implant housing out of the first needle. The implant deployment member may be hollow, and an implant housing retainer may extend through the implant deployment member. The implant deployment member may have a tab for an operator to activate the implant deployment member. The implant housing retainer may be detachable from the tab of the implant deployment member.

[0022] In some examples, the implant delivery device may further comprise a medical implant comprising an implant housing disposed within the lumen of a first needle, and an electrode lead wire extending from the implant housing and carried by a second needle. The electrode lead wire may be carried within the lumen of the second needle, or it may be attached to the second needle at an attachment point located at or near its distal end and extending along one side of the second needle.

[0023] The combination of the implant delivery device and the medical implant may be packaged for single use.

[0024] In some examples, the medical implant is an implantable nerve stimulation device. The medical implant can be configured to stimulate a patient's nerve, such as the greater occipital nerve. In other examples, the medical implant may be a non-stimulating implant, such as a diagnostic implant. The diagnostic implant can include an implant housing and an antenna for wireless communication with an external device. The stimulating implant may be implanted such that the implant housing is positioned at a first depth by a first needle, and the antenna is implanted at a substantially identical depth, such as at a substantially uniform distance from the outer surface of the skin, by a second needle. To achieve this, the first needle and the second needle can be pushed into the patient substantially parallel to the skin.

[0025] Hereinafter, embodiments of the present invention will be further described with reference to the accompanying drawings.

Brief Description of the Drawings

[0026] [Figure 1] It is a diagram showing a medical implant. [Figure 2] It is a diagram showing a medical implant located at a fixed position within a patient, specifically a subcutaneous position. [Figure 3] It is a schematic cross-sectional view of a part of a delivery device for implanting a medical implant into a patient, specifically the first needle and the second needle of the delivery device. [Figure 4] It is a schematic cross-sectional view of a delivery device with a handle in the configuration before implanting the medical implant. [Figure 5] It is a schematic cross-sectional view of the delivery device after the electrode lead wire of the medical implant is released. [Figure 6] It is a schematic cross-sectional view of the delivery device after the medical implant is released. [Figure 7] It is a perspective view showing the ends of the first needle and the second needle and the medical implant held by the first needle and the second needle. [Figure 8A] This is a diagram of the second needle. [Figure 8B] This is a diagram of the first needle. [Figure 9] This figure shows an example of a delivery device for implanting a medical implant into a patient. [Figure 10] This figure shows the second needle of the delivery device shown in Figure 9, which has an operating tab. [Figure 11] This is an alternative diagram of the delivery device shown in Figure 9. [Figure 12] Figure 9 shows the locking mechanism for the second needle and actuation tab of the delivery device. [Figure 13A] This figure shows an example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 13B] This figure shows an example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 14A] This figure shows another example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 14B] This figure shows another example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 14C] This figure shows another example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 15A] This figure shows another example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 15B] This figure shows another example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 15C] This figure shows another example of a retaining mechanism for releasably holding the implant housing of a medical implant within a first needle. [Figure 16] This figure shows an example of an implant delivery device in which the second needle is initially positioned in the retracted position. [Figure 17A] This figure shows the operation of a delivery device for implanting medical implants into a patient. [Figure 17B] This figure shows the operation of a delivery device for implanting medical implants into a patient. [Figure 17C] This figure shows the operation of a delivery device for implanting medical implants into a patient. [Figure 17D] This figure shows the operation of a delivery device for implanting medical implants into a patient. [Figure 17E] This figure shows the operation of a delivery device for implanting medical implants into a patient. [Figure 18A] This is a schematic cross-sectional view of part of a delivery device, another example for implanting a medical implant within a patient, with the operating tab moved toward the handle during use. [Figure 18B] This is a schematic cross-sectional view of part of a delivery device, another example for implanting a medical implant within a patient, with the operating tab moved toward the handle during use. [Figure 19] Figures 18A and 18B show perspective views of the delivery devices in the example. [Figure 20] Figure 19 is a partial cross-sectional view of the delivery device, showing a rack and pinion mechanism. [Figure 21A] This is a schematic cross-sectional view of part of a delivery device for implanting a medical implant within a patient, in another example, with the second needle initially positioned in a retracted position. [Figure 21B] This is a schematic cross-sectional view of part of a delivery device for implanting a medical implant within a patient, in another example, with the second needle initially positioned in a retracted position. [Figure 22A] Figures 18A and 18B show the release mechanism of the delivery device in the example for releasing the implant housing from the first needle during use. [Figure 22B]Figures 18A and 18B show the release mechanism of the delivery device in the example for releasing the implant housing from the first needle during use. [Figure 23A] Figures 18A to 22B show the operation of the delivery devices used to implant medical implants into a patient. [Figure 23B] Figures 18A to 22B show the operation of the delivery devices used to implant medical implants into a patient. [Figure 23C] Figures 18A to 22B show the operation of the delivery devices used to implant medical implants into a patient. [Figure 23D] Figures 18A to 22B show the operation of the delivery devices used to implant medical implants into a patient. [Figure 23E] Figures 18A to 22B show the operation of the delivery devices used to implant medical implants into a patient. [Figure 24] This figure shows a second needle, an alternative example, which has mounting points for attaching electrode lead wires. [Figure 25] This figure shows a first needle, an alternative example having a sharp projection. [Figure 26] This figure shows an alternative example of the first needle having a window corresponding to the implant housing within the first needle. [Modes for carrying out the invention]

[0027] Figures 1 and 2 show medical implant 1 and its use in a patient. As will be further described below, medical implant 1 is implantable in a patient and capable of acting to sense and / or stimulate nerves. In some examples, medical implant 1 is implantable to sense and / or stimulate the greater occipital nerve, but the same or similar implant may be implantable to sense and / or stimulate other nerves, specifically other peripheral nerves of the peripheral nervous system. For example, medical implant 1 may be implantable to sense and / or stimulate the tibial nerve, the sacral nerve (e.g., for the treatment of urinary incontinence), or the vagus nerve (e.g., for the normalization of pancreatic juice secretion).

[0028] As shown in Figure 1, the medical implant 1 comprises an implant housing 2 and elongated electrode lead wires 3. The implant housing 2 may house electronic components of the medical implant 1, such as a printed circuit board, transceiver, wireless power receiver, and / or sensor electronics. For example, the implant housing is hermetically sealed.

[0029] The electrode lead wire 3 extends from the implant housing 2 and is flexible. The electrode lead wire 3 comprises at least one electrode 4, and in some examples comprises multiple electrodes 4 spaced apart along the length of the electrode lead wire 3. These electrodes 4 are connected to electronic equipment within the implant housing 2.

[0030] In some cases, the implant housing 2 has a diameter between approximately 0.5 mm and 5 mm, for example, between approximately 1 mm and 3 mm. The implant housing 2 has a maximum length of approximately 10 mm, for example, between approximately 5 mm. In some cases, the electrode lead wire 3 has a diameter between approximately 0.3 mm and 1.5 mm, for example, between approximately 0.5 mm and 1.3 mm. The electrode lead wire 3 has a maximum length of approximately 100 mm, for example, between approximately 50 mm. However, it will be understood that the diameter of the implant housing 2 corresponds to the size of the electrode housed within the implant housing 2, and the length of the electrode lead wire 3 corresponds to the anatomical structure surrounding the target nerve; therefore, depending on the depth of the nerve within the muscle tissue, a shorter or longer electrode lead wire 3 may be appropriate.

[0031] As shown in Figure 2, when the medical implant 1 is implanted in the patient, it is positioned below the surface of the skin, specifically below the epidermis 5. The implant housing 2 may be positioned in the dermis 6 or in the subcutaneous tissue 7. Positioning the implant housing 2 in the subcutaneous tissue 7 may be advantageous in that it results in less damage and / or irritation to the patient.

[0032] As shown in the figure, the electrode lead wire 3 extends from the implant housing 2 through the underlying tissue, specifically through the muscle 8, to a location near the target nerve 9. The electrode lead wire 3 is positioned so that the electrode (4, see Figure 1) is in contact with or near the nerve 9, thereby allowing the electrode 4 to be used to sense and / or stimulate the nerve 9.

[0033] An external device (not shown) can wirelessly power and communicate with the medical implant 1, specifically with the electronic equipment within the implant housing 2. This external device may be positioned on the skin near the medical implant 1. The external device may be fixed to the skin near the medical implant 1.

[0034] In some examples, medical implant 1 is a nerve stimulation implant that is implanted to target the greater occipital nerve of the patient, and electrode 4 supplies an electrical signal, such as an electric current, to stimulate the greater occipital nerve. In some examples, the electrical signal may be a voltage-regulated stimulus. Such stimulation may result in relief of chronic pain, such as occipital neuralgia and intractable migraines, and / or other therapeutic benefits.

[0035] Figures 3 to 22E show examples of implant delivery devices 10 for implanting the medical implant 1 shown in Figure 1 at the location shown in Figure 2.

[0036] Figures 3 to 16D show an implant delivery device 10 of a first example. As shown in Figure 3, the implant delivery device 10 comprises a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 are parallel and both extend longitudinally. The second needle 13 extends further than the first needle 12. Specifically, the first needle 12 has a tip 14, such as a beveled tip, and the second needle 13 extends beyond the tip 14 of the second needle. The second needle 13 also has a tip 15, specifically a beveled tip. The second needle 13 has a larger gauge than the first needle 12, specifically a smaller diameter than the first needle 12.

[0037] During use, the implant housing 2 is received within the first needle 12, specifically within the lumen of the first needle 12. During use, the electrode lead wire 3 is received within the second needle 13, specifically within the lumen of the second needle 13. As shown in the figure, the electrode lead wire 3 extends along most of the second needle 13 toward the tip 15. As further explained with reference to Figure 7, a portion of the electrode lead wire 3 adjacent to the implant housing 2 extends through the opening of the second needle 13. Thus, during use, the medical implant 1 is housed between the first needle 12 and the second needle 13 of the delivery device 10.

[0038] As shown in Figure 3, the first needle 12 and the second needle 13 are offset in the axial direction. Specifically, 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 within the first needle 12 (specifically, within the lumen of the first needle) so as to be partially housed within the first needle 12 alongside the implant housing 2.

[0039] Referring to Figure 7, the second needle 13 includes a slot 18, as shown in Figure 3, which allows a portion of the electrode lead wire 3 to extend outside the second needle 13 and connect to the implant housing 2. As will be further described below, the slot 18 may extend to the tip 15 of the second needle 13.

[0040] In some examples, the second needle 13 may comprise a sheath having an opening that extends entirely or substantially along one side.

[0041] As will be described in more detail below, during use, the first needle 12 and the second needle 13 together penetrate the patient's skin to simultaneously position the implant housing 2 at a first depth and the electrode lead wire 3 at a second depth within the patient. The implant delivery device 10 then releases and deploys the medical implant 1 to place the medical implant 1 in the position shown in Figure 2. The tip 14 of the first needle 12 and the tip 15 of the second needle 13 are sharp tips, respectively, and are adapted to puncture the patient's skin and penetrate tissue to position the first needle 12 and the second needle 13 at the appropriate depths. The tips 14 and 15 may be beveled tips as known to those skilled in the art.

[0042] In some examples, the first needle 12 may have a gauge number between 6 gauge and 15 gauge, for example, 10 gauge. In some examples, the second needle 13 may have a gauge number between 15 gauge and 25 gauge, for example, 20 gauge.

[0043] In the various examples described below, the second needle 13 is retractable relative to the first needle 12 in order to deploy the electrode lead wire 3. A slot 18 along the second needle 13 (see Figure 7) allows for the deployment of the electrode lead wire 3.

[0044] In some examples, the implant housing 2 is removably attached to the first needle 12 (or another part of the implant delivery device 10) and is released before deployment.

[0045] In some examples, the implant housing 2 can be deployed from the first needle 12 by simply pulling the implant delivery device away from the patient and holding the medical implant in place by the frictional force between the electrode lead wire 3 and the patient's tissue. In other examples, the implant delivery device 10 may include a deployment member configured to deploy the implant housing 2 to the appropriate anatomical site by pushing the implant housing 2 away from the first needle 12.

[0046] Figures 4 to 6 show further parts of the implant delivery device 10 in this example and illustrate the operation of the implant delivery device 10 for deploying the medical implant 1 into the patient.

[0047] As shown in the illustration, the implant delivery device 10 in this example further comprises a handle 11. The handle 11 is configured to be held by an operator. The first needle 12 is fixed to the handle 11.

[0048] 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 the tip 15. Specifically, the actuation tab 16 may be a grip handle or similar that will be grasped by the operator.

[0049] The second needle 13 is retractable relative to the first needle 12. Specifically, the second needle 13 can slide through the first needle 12 and handle 11 from the positions shown in Figure 4 and Figure 5. In this example, the second needle 13 is retractable by pulling the actuation tab 16 away from the patient. This retraction of the second needle 13 deploys the electrode lead wire 3. A slot 18 along the second needle 13 (see Figure 7) is provided for the portion of the electrode lead wire 3 that connects to the implant housing 2. The slot 18 extends to the tip 15 of the second needle 13.

[0050] 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 figure, the locking device 17 may be located at or near the position of the actuation tab 16, and in some examples locks the actuation tab 16 to the handle 11. The locking device 17 locks the second needle 13 to the extended position shown in Figure 4.

[0051] In the position shown in Figure 4, the operator can insert the implant delivery device 10 into the patient. The position of the second needle 13 is locked relative to the handle 11, so that the operator can push the implant delivery device 10 into the patient using the handle 11.

[0052] Referring to Figures 4 and 2, when the implant delivery device 10 is pushed into the patient, the second needle 13 first penetrates the skin 5, and as the implant delivery device 10 is pushed further, the first needle 12 then penetrates the skin 5. This positions the first needle 12 and the second needle 13 at the appropriate depth within the patient, and simultaneously positions the implant housing 2 and electrode lead wires 3 at the appropriate depth.

[0053] In some cases, the operator may use an ultrasound imaging device to monitor the position of the first needle and, in particular, the second needle 13, and guide the second needle 13 toward the target nerve 9.

[0054] Once the implant delivery device 10 is in position, the tip 15 of the second needle 13 (and the electrode lead wire 3 located within the second needle 13) is positioned adjacent to the nerve, and the tip 14 of the first needle 12 (and the implant housing 2 within the first needle 12) is positioned within the subcutaneous tissue, the second needle 13 may retract to the position shown in Figure 5.

[0055] The second needle 13 is retracted by unlocking the locking mechanism 17 and pulling the actuation tab 16 against the handle 11, which causes the second needle 13 to slide to the retracted position shown in Figure 5. The actuation tab 16 is pulled away from the patient. While the second needle 13 is retracting, the handle 11 and the first needle 12 remain in place. As shown, when the second needle 13 is retracted, the electrode lead wire 3 is deployed and exposed to the surrounding tissue (and nerves).

[0056] Next, as shown in Figure 6, the implant delivery device 10 is withdrawn from the patient, and the implant housing 2 is deployed from the first needle 12. In this example, the frictional force between the electrode lead wire 3 and the tissue (see muscle 8 in Figure 2) is sufficient to hold the medical implant 1 in place when the implant delivery device 10 is withdrawn, thereby deploying the implant housing 2 from the first needle 12 when the implant delivery device 10 is withdrawn from the patient.

[0057] In other examples detailed thereafter, the implant delivery device 10 may include a deployment member configured to push the implant housing 2 out of the first needle 12. In some examples detailed thereafter, the implant delivery device 10 may also have a retaining member configured to releasably attach the implant housing 2 to the first needle 12 and / or handle 11, the retaining member being able to release the implant housing 2 after the second needle 13 has retracted and before the first needle 12 has been removed from the patient.

[0058] Figures 7, 8A, and 8B show the first needle 12 and the second needle 13. As shown, the electrode lead wire 3 is received in the second needle 13, which has a slot 18 for connecting to the implant housing 2 in the first needle 12. The slot 18 extends partially from the tip 15 along the second needle 13. The slot 18 may extend along the entire length of the second needle 13. The second needle 13 may be in the form of a sheath. The first needle 12 receives the implant housing 2.

[0059] The first needle 12 is equipped with a beveled tip 14, and the second needle 13 is equipped with a beveled tip 15. The beveled tips 14 and 15 are sharp to puncture the patient's skin and penetrate tissue during use.

[0060] As shown in Figure 7, the second needle 13 extends through the lumen of the first needle 12. Specifically, as shown in Figure 8B, the first needle 12 comprises a primary portion 19A and a secondary portion 19B. The primary portion 19A and the secondary portion 19B are merged so that the first needle 12 has a single lumen. The primary portion 19A and the secondary portion 19B are shaped to define two identifiable portions 19A and 19B.

[0061] The primary portion 19A is shaped to receive the implant housing 2. Specifically, the primary portion 19A is sized to receive the implant housing 2 and has a substantially circular cross-section that holds the implant housing 2 in an axially aligned state within the primary portion 19A.

[0062] The secondary portion 19B is shaped to receive the second needle 13. Specifically, the secondary portion 19B is sized to receive the second needle 13 and has a substantially circular cross-section that holds the second needle 13 in an axially aligned state within the secondary portion 19B.

[0063] In some examples, the secondary portion 19B and the primary portion 19A each have substantially circular cross-sections, and these cross-sections overlap at least partially. In such examples, the implant housing can be pushed into one side of the primary portion 19A by the presence of a second needle 13 within the secondary portion 19B.

[0064] Therefore, the first needle 12 is shaped to receive the implant housing 2 and the second needle 13, and to allow the second needle 13 to slide toward a retracted position. The positioning of the second needle 13 within the lumen of the first needle 12 in this manner is advantageous because, although the puncture wound formed by the second needle 13 during use is expanded by the first needle 12, only one puncture wound is formed in the patient's skin.

[0065] In an alternative example, the second needle 13 does not pass into or through the lumen of the first needle 12. Instead, the second needle 13 may extend through another part of the handle 11.

[0066] Figures 9 to 11 show an example of an implant delivery device 10. As shown, the implant delivery device 10 comprises a handle 11, a first needle 12, and a second needle 13 in the configuration described above with reference to Figures 3 to 8B. Specifically, the first needle 12 is fixed to the handle 11, and the second needle 13 is retractable from an extended position (shown in Figure 9) that extends beyond the end of the first needle 12 to a retracted position (see Figure 16D) that releases an electrode lead wire (3, see Figure 3) by retracting toward the handle 11.

[0067] As shown in Figures 9 and 10, the second needle 13 extends through the handle 11, and portion 13a of the second needle 13 is mounted against the actuation tab 16.

[0068] Figure 9 also shows the implant deployment member 20. This implant deployment member 20 is equipped with a gripping tab 21. As will be further described later, the implant deployment member 20 may be in the form of a tube or plunger configured to slide into the first needle 12 and push the implant housing 2 out of the first needle 12.

[0069] As shown in Figure 11, the handle 11 has an opening 22 through which the first needle 12 is mounted and through which the second needle 13 and the implant deployment member 20 pass.

[0070] Figure 12 shows an example of a locking mechanism 17 described with reference to Figures 4 to 6. This locking mechanism is configured to releasely lock the position of the second needle 13 relative to the handle 11 and the first needle 12. In this example, the locking mechanism includes a locking slot 23 formed in a locking ring 24 on the handle 11. The locking ring 24 may be an integral part of the handle 11 or mounted on the handle 11. The locking slot 23 may be an L-shaped or J-shaped slot shaped to receive a portion of the second needle 13, specifically a portion 13a of the second needle 13 to which an actuation tab 16 is mounted. This portion 13a is capable of entering the slot, and rotation of the second needle 13 (by the actuation tab 16) moves the portion 13a into the end of the locking slot 23 that restricts the axial movement of the second needle 13. Therefore, the second needle 13 can be moved between a locked position and an unlocked position by rotating the actuation tab 16, thereby moving portion 13a in and out of the locking slot 23.

[0071] Figures 13A and 13B show an example of a retaining member configured to releasably secure the implant housing 2 within the first needle 12. As shown, in this example, the first needle 12 includes a retaining member in the form of a retaining tab 25, which contacts the implant housing (2, see Figure 7) and is configured to hold the implant housing within the first needle 12. The retaining tab 25 is formed by a U-shaped notch in the first needle 12 that forms the retaining tab 25, and is partially bent inward, thereby narrowing the inner diameter of the first needle 12 at the position of the retaining tab 25.

[0072] In some examples, the implant housing 2 may have a recess configured to accommodate the retaining tab 25. In other examples, the retaining tab 25 contacts the side wall of the implant housing 2.

[0073] The retaining tab 25 may be configured such that the implant housing 2 can be deployed from the first needle 12 by being pulled from the first needle 12 with a relatively small force. Thus, the frictional force between the electrode lead wire 3 and the patient's tissue may provide sufficient retaining force to overcome the retaining force of the retaining tab 25 by pulling the implant delivery device 10 from the patient after the retraction of the second needle 13 as described above.

[0074] In another example, the implant delivery device 10 further comprises an implant deployment member 20, as shown in Figure 13B. The implant deployment member 20 penetrates an opening 22 in the handle and extends into the first needle 12. From this position, the implant deployment member 20 can function as a plunger for pushing the implant housing 2 out of the first needle 12. The implant deployment member 20 is provided with a gripping tab 21 for operating the implant deployment member 20.

[0075] In some examples, the implant deployment member 20 may be equipped with a locking tab, which is configured to prevent the implant deployment member 20 from moving axially toward the implant housing 2 until the locking tab is released, for example, by rotation of the implant deployment member 20 or the gripping tab 21.

[0076] Figures 14A to 14C show another example of a retaining member configured to releasably secure the implant housing 2 within the first needle 12. In this example, the retaining member consists of a shape memory member 26 which extends between the gripping tab 21 and the implant housing 2, through the handle 11 and in particular through the implant deployment member 20.

[0077] As shown in Figure 14B, the implant housing 2 is provided with mounting points 27, such as holes or hooks. The end of the shape memory member 26 hooks onto these mounting points 27, thereby holding the implant housing 2 within the first needle 12.

[0078] As shown in Figure 14C, the opposing end 26a of the shape memory member 26, located on the opposite side of the hook 27, is attached to an actuating tab 28 that is slidably mounted relative to the gripping tab 21. Therefore, by moving the actuating tab 28 relative to the gripping tab 21, the shape memory member 26 is pulled. Consequently, by pulling the actuating tab 28, the hook located at the end of the shape memory member 26 is deformed, disengaging from the mounting point 27, and the implant housing 2 can be released.

[0079] In some examples, the shape memory member 26 is made of a shape memory polymer or a shape memory alloy such as a nitinol bar. In other examples, the shape memory member 26 may be made of a bimetallic strip, a spring wire, or a piano wire. The shape memory member 26 has a retaining end that engages with a mounting point 27 on the implant housing 2. This retaining end is formed as a shape memory portion and can prevent the implant housing 2 from moving away from the first needle 12 until the retaining end is disengaged from the mounting point 27 by pulling the actuation tab 28.

[0080] The operating tab 28 can be releasably locked against the gripping tab 21 to prevent unintended release of the implant housing 2 from the first needle 12.

[0081] When the shape memory member 26 is disengaged from the attachment point 27, the implant housing 2 can be pulled out from the first needle 12 by the frictional force between the electrode lead wire 3 and the patient's tissue, and / or the implant deployment member 20 can function as a plunger as described above.

[0082] Figures 15A to 15C show another example of a retaining member configured to releasably secure the implant housing 2 within a first needle 12. In this example, the retaining member consists of a thread 29 extending from a gripping tab 21 to the implant housing 2 within the first needle 12. The thread 29 forms a loop through a mounting point 27 on the implant housing 2, with both ends 29a and 29b secured by the gripping tab 21. For example, these ends 29a and 29b may be tied to each other or to a portion of the gripping tab 21. Preferably, the ends 29a and 29b are secured to the gripping tab 21 so that they can be easily untangled or a portion of the thread 29 can be easily accessed.

[0083] Therefore, the thread 29 serves to hold the implant housing 2 within the first needle 12 until it can be removed by cutting or unraveling.

[0084] When the implant housing 2 is released, the implant housing 2 may be pulled out of the first needle 12 by the frictional force between the electrode lead wire 3 and the patient's tissue, and / or the implant deployment member 20 may act as a plunger as described above.

[0085] This thread can also be made of Kevlar thread.

[0086] In the example described above, the second needle 13 is initially in the extended position, and the first needle 12 and the second needle 13 can be positioned simultaneously within the patient. Figure 16 shows an alternative example in which the second needle 13 is initially in the retracted position. In this example, the actuation tab 4 extends from the handle 11, as shown. In the retracted position, the second needle 13 may be located within the first needle 12, as shown, or it may be located within the handle 11 alongside the first needle 12. The electrode lead wire 3 is partially located within the second needle 13, forming a loop between the implant housing 2 and the second needle 13.

[0087] During use, as will be further described below, the first needle 12 is inserted into the patient with the implant delivery device 10 in the configuration shown in Figure 16, and the actuation tab 16 is then pushed toward the handle 11, thereby extending the second needle 13 beyond the first needle 12 and bringing the electrode lead wire 3 into position. In this position, the locking mechanism 17 may be engaged to lock the actuation tab 16 and the second needle 13 into position.

[0088] In some examples, the implant delivery device 10 can be removed from the patient with the second needle 13 in the extended position. A pusher (as described above) may be provided to push the medical implant 1 out of the first needle 12 and the second needle 13. In other examples, the second needle 13, after being extended, can be retracted by pulling the actuation tab 16 away from the handle 11 in the manner described above, thereby releasing the electrode lead wire 3.

[0089] Figures 17A to 17E show how to operate the implant deployment device 10 to deploy the medical implant 1 within the patient.

[0090] In these examples, as described above, the implant delivery device 10 comprises a handle 11, a first needle 12 having an implant housing 2, and a second needle having an electrode lead wire 3. Also as described above, the implant delivery device 10 further comprises an actuation tab 16 for retracting the second needle 13 and an implant deployment member 20 for pushing the implant housing 2 out of the first needle 12.

[0091] The implant delivery devices 10 shown in Figures 17A to 17E may include retaining members as described in any of Figures 13A to 15C. As will become apparent later, Figure 17A relates to the example in Figure 16 where the second needle 13 is initially in the retracted position, and Figures 17B to 17E relate to all of the examples in Figures 3 to 16.

[0092] Figure 17A shows the implant delivery device 10 in its initial state with the second needle 13 retracted as described with reference to Figure 16. In this state, the operator pushes the first needle 12 through the patient's skin 5 into the deployment position of the medical implant 1.

[0093] The implant delivery device 10 and the medical implant 1 are pre-assembled and packaged as a disposable unit. Therefore, the operator is supplied with the implant delivery device 10 with the medical implant 1 pre-loaded into the first needle 12 and the second needle 13.

[0094] Next, as shown in Figure 17B, the actuation tab 16 is pushed toward the handle 11, extending the second needle 13 beyond the first needle 12 to a second depth. The second needle 13 carries the electrode lead wire 3. The operator may use an ultrasound imaging device to assist in guiding the second needle 13 toward the nerve 9. In this state, the first needle 12 positions the implant housing 2 at the appropriate depth in the patient's tissue, while the second needle 13 simultaneously positions the electrode lead wire 3 at the appropriate depth in the patient's tissue.

[0095] Furthermore, Figure 17B shows the implant delivery device 10 from Figures 3 to 9 in its initial state, with the second needle 13 in its extended position covering the electrode lead wire (not shown in Figure 17B). The second needle 13 is locked to the handle 11 by a locking mechanism, such as the locking slot 23 described with reference to Figure 12.

[0096] The implant delivery device 10 and the medical implant 1 are pre-assembled and packaged as a disposable unit. Therefore, the operator is supplied with the implant delivery device 10 with the medical implant 1 pre-loaded into the first needle 12 and the second needle 13.

[0097] In this state, the operator pushes the first needle 12 and the second needle 13 through the patient's skin 5 into the deployment position of the medical implant 1. The operator may use an ultrasound imaging device to assist in guiding the second needle 13 toward the nerve 9.

[0098] In the appropriate position shown in Figure 17B, the second needle 13 is located within the muscle tissue 8 near the nerve 9, and the end of the first needle 12, which houses the implant housing 2, is positioned in the subcutaneous tissue 7. Both the first needle 12 and the second needle 13 penetrate the epidermis 5 and the dermis 6. Since the second needle 13 is positioned within the lumen of the first needle 12, there is only one perforation in the epidermis 5 and dermis 6.

[0099] In one example, the second needle 13 may have one or more lateral openings corresponding to electrodes (4, see Figure 1) on the electrode lead wire, which allow the position of the electrode lead wire to be checked before the second needle 13 is retracted. If such check reveals that the electrode lead wire is not in the correct position relative to the nerve 9, the implant delivery device 10 may then be removed at least partially, and the second needle 13 may be repositioned.

[0100] In some examples, as further explained with reference to Figure 26, the first needle 12 may be made of a metal such as stainless steel or aluminum. In such examples, the first needle 12 may be provided with a non-conductive window formed by, for example, a plastic insert, which may enable wireless communication between an external device and the implant housing 2 when the implant housing 2 is positioned within the first needle 12. This makes it possible to inspect the position of the electrode lead wires and to inspect the electronic equipment installed in the implant housing 2 before the implant is deployed.

[0101] As shown in Figure 17C, the operator then unlocks the second needle 13 (for example, by rotating the second needle 13 to disengage the locking mechanism in Figure 12) and retracts the actuation tab 16 away from the patient. This moves the second needle 13 into a retracted position within the first needle 12, and the electrode lead wire 3 is released.

[0102] In one example, the second needle 13 is partially retracted to expose only the end of the electrode lead wire 3 where the electrode (4, see Figure 1) is located. This partial retraction allows for inspection of the position of the electrode lead wire 3 relative to the nerve 9. If such inspection reveals that the electrode lead wire is not precisely positioned relative to the nerve 9, the second needle 13 is then pushed back in, thereby re-covering the electrode lead wire 3, allowing the implant delivery device 10 to be at least partially removed, and the second needle 13 to be repositioned.

[0103] If the electrode lead wire 3 is in the correct position, the second needle 13 is fully retracted to release the electrode lead wire 3.

[0104] Next, as shown in Figure 17D, the implant housing 2 is released and deployed from the first needle 12. Specifically, if the implant delivery device 10 includes a retaining member as described in any of Figures 13A to 15C, this retaining member is released to release the implant housing 2.

[0105] In some cases, the frictional force between the electrode lead wire 3 and the tissue, specifically the muscle 8, provides sufficient retention force to pull the implant housing 2 out of the first needle 12 when the implant delivery device 10 is withdrawn from the patient.

[0106] In another example, as shown in Figure 17D, the implant deployment member 20 (and gripping tab 21) is pushed toward the handle 11 to push the implant housing 2 away from the first needle 12. The implant deployment member 20 is pushed toward the handle 11, and at the same time the handle 11 is moved away from the skin 5, thereby allowing the implant housing 2 to be deployed without pushing or pulling the electrode lead wires 3.

[0107] Therefore, the medical implant 1 is deployed as shown in Figure 17E, and the implant delivery device 10 can be removed from the patient.

[0108] Figures 18A to 21B show an alternative example of an implant delivery device 10. In this example, the implant delivery device 10 comprises a handle 11, a first needle 12 for holding the implant housing 2, and a second needle 13 for holding the electrode lead wire 3, as previously described. In this example, the actuation tab 16 is configured to be pushed toward the handle 11 and the patient to retract the second needle 13.

[0109] Specifically, as illustrated, the implant delivery device 10 has a rack and pinion mechanism for converting the movement of the actuating tab 16 toward the patient into the retraction of the second needle 13 toward the patient. As illustrated, this rack and pinion mechanism includes a first rack portion 30A mounted on or formed as part of the second needle 13. The rack and pinion mechanism also includes a second rack portion 30B mounted on or formed as part of the actuating tab 16. A pinion gear 31 is rotatably mounted within the handle 11 and engages 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 illustrated, behind the end of the first needle 12 within the handle 11. Therefore, as shown in Figure 18B, when the actuation tab 16 is pushed toward the patient, the rack and pinion mechanism retracts the second needle 13 toward the patient, releasing the electrode lead wire 3.

[0110] Advantageously, by pushing the actuation tab 16 rather than pulling it, one-handed operation of the implant delivery device 10 may be possible.

[0111] Furthermore, by pressing the actuation tab 16 toward the patient, the implant housing 2 can be released from the first needle 12, as will be described in more detail thereafter with reference to Figures 22A and 22B.

[0112] Figures 19–21B show an example of an implant delivery device 10 having a push-actuated tab 16 and a rack-and-pinion mechanism, which will be described with reference to Figures 18A and 18B. As shown, this implant delivery device 10 is similar to the example in Figure 9 and has a handle 11, a first needle 12, and a second needle 13. In this example, as is more clearly shown in Figure 20, a guide member 32 extends from the handle 11 in the direction away from the patient (opposite to the needles 12 and 13). The guide member 32 is fixed to the handle 11. The actuated tab 16 and the second rack portion 30B are slidable along the guide member 32 toward the handle 11 in order to retract the second needle 13 as described above.

[0113] Furthermore, as shown in Figure 20, a locking mechanism 17 is provided to lock the operating tab 16 against the guide member 32. The locking mechanism 17 locks the operating tab 16 (and the second rack portion 30B) against the guide member 32 and therefore further against the handle 11 so that the first needle 12 and the second needle 13 can be inserted into the patient while locked together.

[0114] Once the first needle 12 and the second needle 13 are positioned within the patient, the locking mechanism 17 is disengaged, releasing the operating tab 16 and the second rack portion 30B, which slide along the guide member 32 toward the handle 11, thereby allowing the second needle 13 to retract.

[0115] As shown in Figure 20, in this example, the locking mechanism 17 includes a spring-loaded pin 33 that is attached to the actuation tab 16 and configured to engage with a corresponding hole 34 on a guide member 32. A spring 38 is positioned to push the pin 33 into the hole 34. A button 35, when operated by the user, disengages the pin 33 from the hole 34, thereby releasing the actuation tab 16 and allowing it to move along the guide member 32. As shown, the button 35 and the pin 33 have opposing angled surfaces 37a, 37b, which move the pin 33 out of the hole 34 when the button 35 is pressed down. The button 35 is configured to be pressed down toward the patient in the same direction in which the actuation tab 16 is moved to retract the second needle 13. In this way, the user can retract the second needle 13 in a single motion by pressing down the button 35 and pushing the actuation tab 16 toward the handle 11.

[0116] As shown in the figure, the guide member 32 may have one or more intermediate holes 36a, 36b, which are positioned between the hole 34 and the handle 11, allowing the actuation tab 16 to be locked to the guide member 32 in various positions. In some examples, the first intermediate hole 36a may correspond to the position of the actuation tab 16 when the second needle 13 is withdrawn to release the electrode lead wire. In some examples, as will be further described later, the second intermediate hole 36b may correspond to the position of the actuation tab 16 when the release mechanism releases the implant housing.

[0117] Figures 21A and 21B show an example of an implant delivery device 10 similar to those shown in Figures 18A to 20. In this example, the implant delivery device 10 comprises a handle 11, a first needle 12 for holding the implant housing 2, a second needle 13 for holding the electrode lead wire 3, and an actuation tab 16 configured to be pushed toward the handle 11 and the patient in order to retract the second needle 13. The implant delivery device 10 has a rack and pinion mechanism for converting the movement of the actuation tab 16 into the movement of the second needle 13 in the same manner as described with reference to Figures 18A to 20.

[0118] As shown in Figure 21A, in this example, the second needle 13 is initially in the retracted position. This retracted position may be located within the first needle 12 as shown, or alongside the first needle 12 in the handle 11. The electrode lead wire 3 is partially located within the second needle 13, forming a loop between the implant housing 2 and the second needle 13. In this position, the locking mechanism is engaged such that the pin (33, see Figure 20) is located within the first intermediate hole (36a, see Figure 20).

[0119] As will be further described below, during use, the first needle 12 is inserted into the patient with the implant delivery device 10 in the configuration shown in Figure 21A, and the actuating tab 16 is retracted away from the handle 11 so as to extend the second needle 13 beyond the first needle 12 and bring the electrode lead wire 3 into position. In this position, the locking mechanism is engaged so that the pin (33, see Figure 20) is positioned within the hole (34, see Figure 20). The second needle 13 is then retracted by pushing the actuating tab 16 toward the handle 11 in the manner described above, thereby releasing the electrode lead wire 3.

[0120] Similar to the examples in Figures 18A to 20, the implant delivery devices in Figures 21A and 21B may have a release mechanism for releasing the implant housing 2 from the first needle 12.

[0121] Figures 22A and 22B show a release mechanism 39 of an example of the implant delivery device 10 shown in Figures 18 to 21B. The release mechanism 39 holds the implant housing 2 within a first needle (not shown in Figures 21A and 21B) and is operable to release the implant housing 2 so that the delivery device can be removed and the implant 1 can be left in place. Figure 22A shows the release mechanism 39 engaged with the implant housing 2 and holding the implant housing 2 within the first needle, and Figure 22B shows the release mechanism 39 after the operation in which the implant housing 2 has been released. The release mechanism 39 is at least partially housed within the first needle.

[0122] As shown in the figure, the release mechanism 39 comprises a retaining member, which in this example comprises a clamping cap 40. The clamping cap 40 has a tapered recess 41 that can be pressed onto the end of the implant housing 2 to clamp it onto the implant housing 2. In the position shown in Figure 22A, the implant housing 2 is mounted against the clamping cap 40, thereby holding the implant housing 2 within the first needle and delivery device.

[0123] The clamping cap 40 is movable to the release position shown in Figure 22B, in which position the clamping cap 40 separates from the implant housing 2, releasing the implant housing 2, thereby allowing the delivery device 10 to be removed and the implant to remain in place. As previously described, the release mechanism 39 is operated by moving the actuation tab (16, see Figures 18 to 21B).

[0124] As shown in Figures 22A and 22B, the clamping cap 40 further comprises a projection 42, which extends away from the tapered recess 41 and is mounted on the actuator member 43 via a pin 44. The actuator member 43 is operable to pull the clamping cap 40 away from the implant housing 2 by moving axially away from the implant housing 2. The movement of the actuator member 43 is constrained by a pin 45 extending from the actuator member 43 through a slot 46 formed in part of the handle 11 of the delivery device. The slot 46 has a notch 46a in which the pin 45 is positioned before the release mechanism 39 is operated. A spring 47 acts between the actuator member 43 and an anchor 50 fixed in the first needle, thereby biasing the actuator member 43 axially away from the implant housing 2. The notch 46a holds the actuator member 43 axially against the force of the spring 47. As shown in Figure 22A, in this position, the release mechanism 39 is spring-loaded.

[0125] As the actuation tab (16, see Figure 20) is moved into the handle 11, the distal end 48 of the actuation tab passes through and approaches the release mechanism 39 and engages with the pin 45. Specifically, the distal end 48 of the actuation tab 16 may be formed on the second rack portion 30B shown in Figures 18A, 18B, 20, 21A, and 21B. As shown in Figure 22B, the distal end 48 is angled such that the engagement between the distal end 48 and the pin 45 causes the pin 45 to exit laterally from the notch 46a and be pushed into the axially extended portion 46b of the slot 46. This releases the actuator member 43 and the clamping member 40, which are moved away from the implant housing 2 under spring force, thereby disengaging the tapered recess 41 from the implant housing 2 as shown in Figure 22B.

[0126] As shown in Figures 22A and 22B, a pusher 49 is provided to prevent the implant housing 2 from moving when the clamping member 40 is moved. Specifically, the pusher 49 extends from the anchor 50, passes through the opening in the clamping member 40, and engages with the end of the implant housing 2. Thus, when the clamping member 40 is moved by the spring 47, the implant housing 2 is held in place.

[0127] As described above, the release mechanism 39 can be operated by moving the actuation tab (16, see Figure 20) into the handle 11 until the distal end 48 moves the pin 45 out of the slot 46, thereby allowing the spring 47 to move the actuator member 43 and the clamping member 40, and to release the implant housing 2. It will be understood that the release mechanism 39 operates in this manner at some point after the second needle has been withdrawn.

[0128] Accordingly, embodiments in Figures 18A to 20 and Figures 22A and 22B provide an implant delivery device 10 having an actuation tab 16 that is pushed toward a handle 11 during use. In the first stage of movement of the actuation tab 16, the second needle 13 is retracted to release the electrode lead wire 3. In the second stage of subsequent movement of the actuation tab 16, a release mechanism is operable to release the implant housing 2 from the first needle 12. Thus, the user can operate the implant delivery device 10 with one hand by pushing the actuation tab 16 toward the handle 11, which first releases the electrode lead wire 3 and then releases the implant housing 2. Once the implant housing 2 is released, the implant delivery device 10 can be removed from the patient.

[0129] Similarly, Figures 21A to 22B present an implant delivery device 10. In this implant delivery device 10, the actuating tab 16 extends the second needle 13 by being pulled away from the handle 11, and the actuating tab 16 is then pushed toward the handle 11 through a first and second stage in the same manner as described above with respect to the examples in Figures 18A to 20 and Figures 22A and 22B.

[0130] Figures 23A to 23E illustrate how to operate the implant delivery device 10 from Figures 18A to 22B to deploy the medical implant 1 within a patient. As will become apparent later, Figure 23A relates to the examples in Figures 22A and 22B, and Figures 23B to 23E relate to all embodiments of Figures 18A to 22B.

[0131] Figure 23A shows the implant delivery device 10 in its initial state as shown in Figures 22A and 22B, with the second needle 13 in a retracted position as also shown in Figure 22A. In this state, the operator pushes the first needle 12 through the patient's skin 5 into position for deploying the medical implant 1.

[0132] Next, as shown in Figure 23B, the operating tab 16 is retracted away from the handle 11, extending the second needle 13 beyond the first needle 12 to a second depth. The second needle 13 carries the electrode lead wire 3, as shown in Figure 22B. In this state, the first needle 12 positions the implant housing 2 at the appropriate depth in the patient's tissue, while the second needle 13 simultaneously positions the electrode lead wire 3 at the appropriate depth in the patient's tissue.

[0133] Furthermore, Figure 23B shows the initial state of the implant delivery device shown in Figures 18A to 20, where the second needle 13 is in an extended position covering the electrode lead wire (not shown in Figure 23B). The second needle 13 is locked to the handle 11 by the locking mechanism shown in Figure 20.

[0134] In this state, the operator pushes the first needle 12 and the second needle 13 through the patient's skin 5 into position for deploying the medical implant 1. The operator may use an ultrasound imaging device to assist in guiding the second needle 13 toward the nerve 9.

[0135] In the position shown in Figure 23, the second needle 13 is located near the nerve 9 within the muscle tissue 8, and the end of the first needle 12, which houses the implant housing 2, is positioned in the subcutaneous tissue 7. Both the first needle 12 and the second needle 13 penetrate the epidermis 5 and the dermis 6. Since the second needle 13 is positioned within the lumen of the first needle 12, there is only one perforation in the epidermis 5 and dermis 6.

[0136] In one example, the second needle 13 may have one or more lateral openings corresponding to electrodes (4, see Figure 1) on the electrode lead wire, which allow the position of the electrode lead wire to be checked before the second needle 13 is retracted. If such check reveals that the electrode lead wire is not in the correct position relative to the nerve 9, the implant delivery device 10 may then be removed at least partially, and the second needle 13 may be repositioned.

[0137] In some examples, the first needle 12 may be made of a metal such as stainless steel or aluminum. As further illustrated with reference to Figure 26, in such examples, the first needle 12 may be provided with a non-conductive window formed by, for example, a plastic insert, which may enable wireless communication between an external device and the implant housing 2 when the implant housing 2 is positioned within the first needle 12. This makes it possible to inspect the position of the electrode lead wires and to inspect the electronic equipment located within the implant housing 2 before the implant is deployed.

[0138] As shown in Figure 23C, the operator then retracts the second needle 13 by pressing the button 35 and the actuation tab 16, which move them along the guide member 32 toward the handle 11. As the actuation tab 16 moves along the guide member 32, the rack and pinion mechanism retracts the second needle 13 and releases the electrode lead wire 3.

[0139] In one example, the second needle 13 is partially retracted to expose only the end of the electrode lead wire 3 where the electrode (4, see Figure 1) is located. This partial retraction allows for inspection of the position of the electrode lead wire 3 relative to the nerve 9. If such inspection reveals that the electrode lead wire is not precisely positioned relative to the nerve 9, the second needle 13 is then pushed back in, thereby re-covering the electrode lead wire 3, allowing the implant delivery device 10 to be at least partially removed, and the second needle 13 to be repositioned.

[0140] If the electrode lead wire 3 is in the correct position, the second needle 13 is fully retracted to release the electrode lead wire 3.

[0141] Next, as shown in Figure 23D, the implant housing 2 is released and deployed from the first needle 12. In some examples, as described with reference to Figures 22A and 22B, a release mechanism 39 is operated to release the implant housing 2.

[0142] In some cases, the frictional force between the electrode lead wire 3 and the tissue, specifically the muscle 8, provides sufficient retention force to pull the implant housing 2 out of the first needle 12 when the implant delivery device 10 is withdrawn from the patient.

[0143] Therefore, the medical implant 1 is deployed as shown in Figure 23E, and the implant delivery device 10 can be removed from the patient.

[0144] Figure 24 shows a second needle 13 in an alternative example. In the example described above, the second needle 13 has a lumen, and the electrode lead wire 3 is received within this lumen so as to extend through this lumen of the second needle 13. This lumen may open through a side of the second needle 13, similar to a sheath. In the example of Figure 24, the second needle 13 has a mounting point at the distal end 52 of the second needle 13. In this example, the mounting point has a hole 51 that extends at least partially into the second needle 13 at the distal end 52. As shown, one end of the electrode lead wire 3 is received within the hole 51, thereby carrying the electrode lead wire 3 along one side of the second needle 13. The distal end 52 of the second needle 13 also has a beveled tip 15. One end of the electrode lead wire 3 is received in the hole 51, extends through the bent portion 53, and then extends along the protruding side of the second needle 13 to the implant housing received in the first needle (12, see Figure 3). The bevel tip 15 serves to puncture the patient's skin and tissue, carrying the end of the electrode lead wire 3 to the appropriate depth in the tissue, as shown in Figure 2. The second needle 13 is then retracted as described above with reference to Figures 2 to 23E, leaving the electrode lead wire 3 in place.

[0145] In the example shown in Figure 24, the bend in the electrode lead wire 3 holds the end of the electrode lead wire 3 within the hole 51 when the second needle 13 is pushed into the patient. When the second needle 13 is retracted, the end of the electrode lead wire 3 is able to slide out of the hole 51 and remain in place.

[0146] In some other examples, the hole 51 extends to the opposite end of the second needle 13, and a pusher or fluid pressure may be applied to push the electrode lead wire 3 out of the hole 51.

[0147] In the illustrated example, the distal end 52 of the second needle 13 further comprises a notch 54, which is configured to receive a bend 53 so that the bevel tip 15 is more fully exposed for puncturing the patient's skin and tissue.

[0148] In some examples, alternatively, the second needle 13 has a hole on its side near the distal end 52. The end of the electrode lead wire 3 can be received in the hole on the side of the second needle 13 and function similarly to the configuration described above. In other similar examples, the second needle 13 may have a socket shaped to receive a matching feature on the electrode lead wire 3, such as a ball. This socket and the matching feature on the electrode lead wire allow the electrode lead wire to be attached to the second needle 13 at the attachment point.

[0149] It will be understood that the second needle 13 in the example in Figure 24 may be used in place of the second needle 13 in any of the aforementioned examples.

[0150] In some examples, as shown in Figure 25, the tip 14 of the first needle 12 is provided with a sharp projection 56 for puncturing the patient's skin and tissue. The first needle 12 having the sharp projection 56 may be used in any of the implant delivery devices 10 of the examples described herein.

[0151] As shown in Figure 26, in some examples, the first needle 12 may have a window 55 corresponding to the position of the implant housing 2 within the first needle 12. Preferably, the first needle 12 is made of a metal such as steel or aluminum. The window 55 may be an opening formed, for example, by removing a portion of the first needle 12. Alternatively, the window 55 may have an insert, such as a plastic insert. The window 55 enables wireless communication and wireless power supply between the implant housing 2 and an external device, allowing for in-situ inspection of the medical implant during deployment into the patient.

[0152] In summary, an implant delivery device is provided for implanting a medical implant into a patient. The medical implant comprises an implant housing and an elongated electrode lead wire extending from the implant housing. The implant delivery device comprises a handle and a first needle fixed to the handle and extending longitudinally, and a second needle having a larger gauge than the first needle. The first needle has a lumen adapted to receive the implant housing of the medical implant, and the second needle is adapted to carry the elongated electrode lead wire of the medical implant. The second needle is retractably mounted to the handle so that the second needle is movable between an extended position and a retracted position. In the extended position, the second needle extends longitudinally beyond the first needle so that during use, the first and second needles can simultaneously position the implant housing to a first depth and the electrode lead wire to a second depth deeper than the first depth. In the retracted position, the second needle is retracted toward the handle to release the electrode lead wire from the second needle.

[0153] Furthermore, a method for implanting a medical implant 1 using an implant delivery device 10 is provided. This method includes positioning a first needle 12 and a second needle 13 within the patient to position the medical implant 1 relative to a nerve 9, retracting the second needle 13 to release the electrode lead wire 3, and then optionally simultaneously deploying the implant housing 2 and removing the implant delivery device 10.

[0154] In some examples, this method may include releasing a retaining member to release the implant housing 2 from the first needle 12. In some examples, this method may include unlocking the second needle 13 from the handle 11 before retracting the second needle 13. In some examples, this method may include partially retracting the second needle 13, checking the position of the electrode lead wire 3 relative to the nerve 9, then re-covering the electrode lead wire 3, and, if necessary, repositioning the second needle 13 before deploying the medical implant 1.

[0155] Throughout the text and claims of this specification, the words “equipment” and “include” and their variations mean “include, but not limited to,” and are not intended (or not intended) to exclude other components, completes, or steps. Throughout the text and claims of this specification, singular words encompass plural words unless otherwise required by the context. Specifically, where an indefinite article is used, what is stated therein should be understood to expect both plural and singular unless otherwise required by the context.

[0156] It should be understood that any features, wholes, characteristics, or groups described in conjunction with specific aspects, embodiments, or examples of the present invention are applicable to any other aspects, embodiments, or examples described herein, to the extent that they do not contradict each other. Any features disclosed herein (including any appended claims, abstract, and drawings) and / or any steps of any similarly disclosed methods or processes may be combined in any combination, except for any combination in which at least some of such features and / or steps are mutually exclusive. The present invention is not limited to any of the details of any of the embodiments described herein. The present invention extends to any novel single feature or any combination of novel features disclosed herein (including any appended claims, abstract, and drawings), or to any novel single step or any combination of novel steps of any similarly disclosed methods or processes. [Explanation of Symbols]

[0157] 1. Medical implants 2. Implant Housing 3. Long, thin electrode lead wires 4 electrodes, working tab 5 Epidermis, skin 6 Dermis 7 Subcutaneous tissue 8. Muscles, muscle tissue 9 Target nerve 10. Implant delivery devices, implant deployment devices 11 handles 12. First Needle 13. Second Needle 13a part 14 Tip, bevel tip 15 Tip, bevel tip 16 Actuating tab, Rotating actuating tab, Push actuating tab 17. Locking devices, locking mechanisms 18 slots 19A Primary part 19B Secondary part 20 Implant deployment member 21 Gripping tab 22 Aperture 23 locking slots 24 Locking Rings 25 Retaining tabs 26 Shape memory member 26a Opposite end 27 mounting points, hooks 28 Operation Tab 29 threads 29a End 29b End 30A First rack section 30B Second rack section 31 Pinion Gear 32 Guide member 33 Spring-loaded pins 34 holes 35 buttons 36a Intermediate hole, first intermediate hole 36b Intermediate hole, second intermediate hole 37a Angled surface 37b Angled surface 38 springs 39 Release mechanism 40 Clamping caps, clamping members 41 Tapered recess 42 Protrusion 43 Actuator component 44 pins 45 pins 46 slots 46a Notch 46b Axial extension 47 springs 48 Distal end 49 Pusher 50 Anchors 51 holes 52 Distal end 53. Bending section 54 Notch 55 windows 56. Sharp projection

Claims

1. An implant delivery device for implanting a medical implant, comprising an implant housing and an elongated electrode lead wire extending from the implant housing, into a patient, The handlebars and A first needle fixed to the handle and extending in the longitudinal direction, comprising a lumen configured to receive the implant housing of the medical implant, A second needle having a larger gauge than the first needle, comprising a lumen configured to receive the elongated electrode lead wire of the medical implant, wherein the second needle is An extended position in which the second needle extends beyond the first needle in the longitudinal direction so that the first needle and the second needle can simultaneously position the implant housing at a first depth and the electrode lead wire at a second depth deeper than the first depth during use, The second needle is retracted toward the handle to release the electrode lead wire from the second needle, A second needle is mounted retractably relative to the handle so as to be movable between the two, An implant delivery device equipped with the following features.

2. The implant delivery device according to claim 1, wherein the second needle has a slot extending along one side and extending into the lumen.

3. The implant delivery device according to claim 2, wherein the first needle and the second needle are arranged non-concentrically such that a portion of the electrode lead wire extends from the lumen of the second needle through the slot to the implant housing during use.

4. The implant delivery device according to claim 1, wherein the second needle has a mounting point at or near the distal end of the second needle, and the mounting point is configured to be mounted on the elongated electrode lead wire such that the elongated electrode lead wire is carried along one side of the second needle.

5. The implant delivery device according to claim 4, wherein the mounting point has a hole configured to receive the end of the elongated electrode lead wire.

6. The implant delivery device according to any one of claims 1 to 5, wherein the second needle is at least partially disposed within the lumen of the first needle.

7. The implant delivery device according to claim 6, wherein the lumen of the first needle comprises a primary portion configured to receive the implant housing and a secondary portion configured to receive the second needle, and the primary portion and the secondary portion each have a partially circular cross-section.

8. The implant delivery device according to any one of claims 1 to 7, further comprising a retaining member configured to releasably secure the implant housing within the lumen of the first needle.

9. The implant delivery device according to claim 8, wherein the retaining member comprises a retaining tab, the retaining tab being formed in the wall of the first needle and configured to engage the implant housing within the lumen of the first needle.

10. The implant delivery device according to claim 8, wherein the implant housing has a mounting point, the retaining member extends from a portion of the handle to the mounting point of the implant housing, and the retaining member is removable to release the implant housing.

11. The implant delivery device according to claim 10, wherein the retaining member comprises a thread that penetrates the mounting point of the implant housing and forms a loop, and the thread can be separated to release the implant housing.

12. The implant delivery device according to claim 10, wherein the retaining member is made of a shape memory member, the shape memory member has a hook end configured to engage with the mounting point of the implant housing, and the opposing end of the shape memory member is configured to move so as to deform the hook end in order to release the implant housing.

13. The implant delivery device according to claim 10, wherein the retaining member comprises a clamping cap configured to be pressed and fitted onto the end of the implant housing.

14. The implant delivery device according to claim 13, further comprising a spring-loaded release mechanism capable of separating the clamping cap from the implant housing.

15. The implant delivery device according to any one of claims 1 to 14, further comprising an actuation tab positioned adjacent to the handle, the actuation tab being configured to be actuated by a user to move the second needle to the retracted position.

16. The implant delivery device according to claim 15, further comprising a locking mechanism configured to lock the second needle in the extended position.

17. The implant delivery device according to claim 16, wherein the locking mechanism comprises a locking slot in the handle, and the second needle is configured to engage with the locking slot such that the second needle is axially locked relative to the handle at one rotational position of the second needle relative to the handle, and the second needle is axially movable relative to the handle at another rotational position of the second needle relative to the handle.

18. The implant delivery device according to any one of claims 15 to 17, wherein the actuation tab is movable in a first direction, thereby moving the second needle in a second direction opposite to the first direction.

19. The implant delivery device according to claim 18, further comprising a rack and pinion mechanism operably coupled between the actuation tab and the second needle.

20. The implant delivery device according to any one of claims 15 to 19, wherein the handle comprises a guide member, and the operating tab is movable along the guide member.

21. The implant delivery device according to claim 20, further comprising a locking mechanism configured to lock the operating tab at a position along the guide member.

22. The implant delivery device according to claim 21, wherein the locking mechanism comprises a button configured to release the locking mechanism in order to move the operating tab along the guide member.

23. The implant delivery device according to any one of claims 15 to 22, further comprising a retaining member configured to releasably secure the implant housing within the lumen of the first needle, wherein the retaining member is actuated by the actuation tab to release the implant housing.

24. The implant delivery device according to claim 23, wherein the actuation tab moves in a first direction over a first distance, thereby moving the second needle to the retracted position, and the actuation tab moves further in the first direction over a second distance, thereby acting the retaining member to release the implant housing.

25. The implant delivery device according to claim 23 or 24, wherein the retaining member comprises a clamping cap configured to be pressed into the implant housing, and the implant delivery device further comprises a spring-loaded release mechanism that is operable to separate the clamping cap from the implant housing when actuated by the actuating tab.

26. The implant delivery device according to any one of claims 1 to 25, further comprising an implant deployment member having a pusher extending from the vicinity of the handle into the lumen of the first needle, wherein the implant deployment member is slidable relative to the first needle to push the implant housing out of the first needle.

27. The implant delivery device according to any one of claims 1 to 26, further comprising a medical implant comprising an implant housing disposed within the lumen of the first needle, and an electrode lead wire extending from the implant housing and carried by the second needle.

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