Method for Percutaneously Implanting a Medical Implant and Delivery Device for Percutaneously Delivering a Medical Implant

Abstract

The present invention provides a delivery device for percutaneously delivering a medical implant to a patient's tissue. The delivery device comprises a delivery sheath having a lumen configured to hold the medical implant. The delivery sheath can be percutaneously positioned to implant the medical implant into the patient's tissue. The delivery sheath comprises a sidewall having a side opening for discharging at least a portion of the medical implant during use.

Description

Technical Field

[0001] The present invention relates to a method for percutaneously implanting a medical implant and a delivery system for percutaneously delivering a medical implant, such as a neural stimulation implant, to a patient's tissue.

Background Art

[0002] It is known to provide an implantable neural stimulation device including a housing and an electrode. 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 electrode. A delivery system can be used to dispose the implantable neural stimulation device in a patient's body (particularly, near a nerve). In this case, an incision is made in the patient, and the neural stimulation device is disposed by passing the delivery system through the incision.

Summary of the Invention

[0003] According to a first aspect of the present disclosure, there is provided a method for percutaneously implanting a medical implant into a patient's tissue. The medical implant includes a wireless power receiver and an elongated electrode lead wire, and the method includes percutaneously implanting the medical implant such that the wireless power receiver is directed toward the skin surface of the patient at an implantation site.

[0004] Thus, wireless power transmission between the medical implant and an external wireless power transmitter is improved.

[0005] In some examples, the method may include percutaneously implanting the medical implant such that the wireless power receiver is directed at an angle within about 20 degrees (preferably within about 10 degrees, more preferably within about 5 degrees) from a normal to the skin surface of the patient at the implantation site.

[0006] In some examples, the method may include a step of percutaneously implanting the medical implant such that the wireless power receiver is oriented substantially parallel to the normal to the patient's skin surface at the implantation site.

[0007] In some examples, the wireless power receiver may include an antenna power receiving unit for receiving wireless power by wireless power coupling. In such an example, the antenna power receiving unit may have a power receiving direction, and the medical implant may be percutaneously implanted such that the power receiving direction of the antenna power receiving unit is oriented towards the patient's skin surface.

[0008] In some examples, the medical implant may include a housing having an antenna portion configured to function as a wireless power receiver. The antenna power receiving unit may have one power receiving direction, and the medical implant may be percutaneously implanted such that the power receiving direction of the antenna power receiving unit is oriented towards the patient's skin surface.

[0009] In some examples, the medical implant may include an elongated housing portion for holding the wireless power receiver. The wireless power receiver may be oriented substantially perpendicular to the housing portion. The method may include a step of percutaneously implanting the medical implant such that the housing portion is oriented substantially parallel to the patient's skin surface at the implantation site.

[0010] In some examples, the housing portion may include a wall portion having a window for wireless power transmission, and the window for wireless power transmission may be provided for performing wireless power transmission through the wall portion of the housing portion. The method may include a step of percutaneously implanting the medical implant such that the window for wireless power transmission is oriented towards the patient's skin at the implantation site.

[0011] In some examples, the method may comprise the step of simultaneously implanting the housing portion and the electrode lead wire transcutaneously. In some examples, the method may comprise the step of implanting the electrode lead wire transcutaneously at a position deeper than the housing portion and / or at an angle different from that of the housing portion. In some examples, the electrode lead wire may be implanted at an angle with respect to the housing portion. In some examples, the method may comprise the step of transcutaneously implanting the electrode lead wire near the nerve or target tissue of the patient and the step of transcutaneously implanting the housing portion into the subcutaneous tissue of the patient.

[0012] In some examples, the method may comprise the step of transcutaneously implanting the electrode lead wire and then the step of transcutaneously implanting the housing portion of the medical implant. In some examples, the method may comprise the step of transcutaneously implanting the electrode lead wire at a position deeper than the housing portion. In some examples, the housing portion may be implanted at an angle with respect to the electrode lead wire. In some examples, the method may comprise the step of transcutaneously implanting the electrode lead wire near the nerve of the patient and the step of transcutaneously implanting the housing portion into the subcutaneous tissue (e.g., fascia) of the patient. In some examples, the method may comprise the step of transcutaneously implanting the electrode lead wire, the step of rotating the housing portion with respect to the electrode lead wire, and then the step of transcutaneously implanting the housing portion.

[0013] In some examples, the medical implant may comprise an elongated housing portion that holds the wireless power receiver. In such examples, the method may comprise the step of transcutaneously implanting the electrode lead wire at an angle non-parallel to the housing portion. In some examples, the method may comprise the step of transcutaneously implanting the housing portion such that the axial direction of the electrode lead wire is substantially perpendicular to the housing portion. That is, the electrode lead wire may be angled with respect to the housing portion. As a result, the electrode lead wire can be appropriately arranged within the tissue, and the housing portion (and the wireless power receiving unit) can be oriented to receive wireless power.

[0014] In some examples, the method may include the steps of percutaneously implanting the electrode lead wire with the housing portion being substantially parallel to the electrode lead wire, and after the electrode lead wire is implanted, arranging the housing portion such that the wireless power receiving unit is oriented towards the patient's skin at the implantation site.

[0015] In some examples, the method may include the step of rotating the housing portion after implanting the electrode lead wire. Advantageously, the housing portion is rotated without displacing the electrode lead wire. In some examples, the electrode lead wire is fixed to the patient's tissue by, for example, one or more displacement prevention members (migration prevention members, movement prevention members). In some examples, prior to rotation, the housing portion is moved towards the patient to reduce the tension of the electrode lead wire while the housing portion is being rotated. In some examples, while the housing portion is being rotated, a portion of the electrode lead wire passes through the opening of the delivery sheath, thereby preventing the delivery sheath from pulling on the implanted electrode lead.

[0016] In some examples, the method may include the step of percutaneously implanting the medical implant using a delivery device. The delivery device may include a delivery sheath for holding the medical implant, and the method may include the step of percutaneously arranging the delivery sheath to percutaneously implant the medical implant.

[0017] In some examples, the delivery sheath may include a first portion for percutaneously implanting the housing portion of the medical implant that holds the wireless power receiver, and a second portion for percutaneously implanting the electrode lead wire. The second portion of the delivery sheath may be parallel to the first portion of the delivery sheath and may extend beyond the first portion of the delivery sheath.

[0018] In some examples, the second portion of the delivery sheath may be retractable relative to the first portion of the delivery sheath. The method may include percutaneously disposing the first portion of the delivery sheath at a first depth, percutaneously disposing the second portion of the delivery sheath at a second depth, retracting the second portion of the delivery sheath to implant the electrode lead wire, and discharging the housing portion from the first portion of the delivery sheath.

[0019] In some examples, the method may further include rotating the first portion of the delivery sheath to change the angle of the housing portion relative to the electrode lead wire after retracting the second portion of the delivery sheath. In some examples, the first portion of the delivery sheath is not percutaneously disposed when rotated. For example, the first portion of the delivery sheath may be withdrawn from the patient before being rotated.

[0020] In some examples, the first portion of the delivery sheath may have an axial direction, and the housing portion may be discharged from the first portion of the delivery sheath in a direction non-parallel to the axial direction of the first portion of the delivery sheath. For example, the housing portion may be discharged from the first portion of the delivery sheath through a side opening in the first portion of the delivery sheath. In some examples, the housing portion is rotated while being discharged from the first portion of the delivery sheath.

[0021] In some examples, the delivery device may comprise a pusher operable to eject the housing portion from the first portion of the delivery sheath. The method may comprise the step of operating the pusher to eject the housing portion from the first portion of the delivery sheath.

[0022] In some examples, the medical implant may be a nerve stimulation implant operable to stimulate a patient's nerve. In other examples, the medical implant may be a diagnostic implant (particularly, a diagnostic implant operable to detect nerve signals). In other examples, the diagnostic implant may detect one or more patient 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.)).

[0023] In some examples, the medical implant may further comprise a wireless power transmitter. In some examples, the medical implant may be operable as a wireless power relay for wirelessly powering another medical implant.

[0024] According to a second aspect of the present disclosure, there is provided a delivery device for percutaneously delivering a medical implant to a patient's tissue.

[0025] The delivery device comprises a delivery sheath having a lumen configured to hold the medical implant, the delivery sheath being percutaneously deployable to implant the medical implant in the patient's tissue.

[0026] The sidewall of the delivery sheath has a side opening for discharging at least a portion of the medical implant during use.

[0027] Advantageously, the side opening enables at least a part of the medical implant to be discharged in a direction not parallel to the delivery sheath, thereby enabling the wireless power receiving device of the medical implant to be directed towards the patient's skin.

[0028] In some examples, the medical implant comprises a housing portion. The medical implant may consist of only the housing portion (without electrode leads). In such an example, the housing portion may be discharged from the side opening. The housing portion may be rotated, for example, using a pusher and / or a guide that rotates the housing portion during discharge, while being discharged from the side opening.

[0029] In some examples, the medical implant may comprise a housing portion and an elongated electrode lead extending from the housing portion. In some examples, the delivery sheath may comprise a first portion configured to hold the housing portion and a second portion configured to hold (carry) the electrode lead. In some examples, the first portion of the delivery sheath may comprise the side opening. The side opening has a size that enables the housing portion to be discharged during implantation. Thus, the housing portion can be implanted non-parallel to the electrode lead. In other examples, the side opening may be dimensioned such that the housing portion can be held in the first portion of the delivery device and a part of the electrode lead can pass through the side opening. This enables the electrode lead to pass through the side opening when the delivery device is rotated during implantation, thereby preventing the electrode lead from being pulled. Thus, this enables the electrode lead and the housing portion to be implanted at different angles (tilts) with respect to each other.

[0030] Advantageously, the side opening enables the housing portion to be embedded non-parallel to the electrode lead wire. In this way, the electrode lead wire can be embedded targeting the patient's nerve or target tissue, and the housing portion can be embedded in an orientation advantageous for wireless power transmission and wireless communication and / or in a position convenient or comfortable for the patient.

[0031] In some examples, the side opening may extend to the tip of the first portion of the delivery sheath. In some examples, the first portion of the delivery sheath includes a slot along one side surface, and the slot constitutes the side opening.

[0032] In some examples, the second portion of the delivery sheath may be retractable relative to the first portion of the delivery sheath for embedding the electrode lead wire. In some examples, the second portion of the delivery sheath may include a slot extending along the side surface of the second portion of the delivery sheath.

[0033] In some examples, the delivery device may further include a pusher operable to push out a part of the medical implant (e.g., the housing portion) through the side opening during use.

[0034] In some examples, the delivery device may further include a guide portion disposed within the delivery sheath, and the guide portion may be configured to guide a part of the medical implant (e.g., the housing portion) discharged from the side opening during use. In some examples, the guide portion has a shape that rotates the housing portion when a part of the medical implant (e.g., the housing portion) is being discharged from the side opening.

[0035] In some examples, the side opening has a size that can hold the housing part in the first part of the delivery sheath and through which a part of the electrode lead wire can pass. In some examples, the first part of the delivery sheath has a shape and size such that, during use, a part of the electrode lead wire can overlap the housing part within the first part of the delivery sheath. In some examples, in the electrode lead wire, the part that overlaps the housing part within the first part of the delivery sheath is aligned with the side opening in the first part of the delivery sheath.

[0036] In some examples, it further comprises a pusher operable to push out the housing part from the first part of the delivery sheath.

[0037] In some examples, the delivery sheath may include a needle and / or a cannula.

[0038] According to a third aspect of the present disclosure, there is provided a method for percutaneously implanting a medical implant into a patient's tissue, the method comprising the steps of providing a delivery device comprising a delivery sheath having a lumen and a side wall in which a side opening is formed; percutaneously disposing the delivery sheath in the patient's tissue; and discharging at least a part of the medical implant through the side opening of the delivery sheath.

[0039] Advantageously, the side opening enables at least a part of the medical implant to be discharged in a direction not parallel to the delivery sheath, and enables the wireless power receiving device of the medical implant to be directed towards the patient's skin.

[0040] In some examples, the medical implant may comprise a housing portion having a wireless power receiver. The method may comprise the step of discharging the housing portion of the medical implant through the side opening of the delivery sheath such that the wireless power receiver is directed towards the patient's skin at the implantation site.

[0041] In some examples, a guide may be used to constrain (limit) the position and orientation of the delivery sheath when the delivery sheath is placed percutaneously. The guide may be adjustable so as to be able to adjust the position and orientation of the delivery sheath. In some examples, the guide may be part of the delivery device. The guide may be removable from the delivery sheath. The guide may lean on or be attached to the patient. The guide may comprise a guide channel through which the delivery sheath passes, the guide channel being configured to constrain (limit) the position and orientation of the delivery sheath. The guide may be configured to target a specific target location (e.g., a target nerve) within the patient's tissue. The guide (particularly, the guide channel and / or a part of the guide engaging with the patient) may be adjustable so as to be able to adjust the position and orientation of the delivery sheath.

[0042] In some examples, the method may comprise the step of rotating the housing portion of the medical implant when the housing portion is being discharged through the side opening of the delivery sheath. In some examples, the method may comprise the step of pushing out the housing portion of the medical implant through the side opening of the delivery sheath.

[0043] In some examples, the medical implant further comprises an elongated electrode lead wire. The method may comprise the steps of percutaneously implanting the electrode lead wire and discharging the housing portion through the side opening of the delivery sheath. Thus, the electrode lead wire and the housing portion can be implanted non-parallel to each other.

[0044] In some examples, the delivery sheath may comprise a first portion having a lumen configured to hold the housing portion and a second portion extending beyond the first portion of the delivery sheath and configured to hold (carry) the electrode lead wire. The method may comprise the step of retracting the second portion of the delivery sheath to implant the electrode lead wire.

[0045] In some examples, the medical implant may comprise a housing portion and an elongated electrode lead wire extending from the housing portion and overlapping the housing portion within the delivery sheath. The method may comprise the steps of implanting the electrode lead wire, rotating the delivery device so that a part of the electrode lead wire passes through the side opening, and implanting the housing portion at an angle different from that of the electrode lead wire.

[0046] In some examples, the delivery sheath may comprise a first portion having a lumen configured to hold the housing portion and a second portion extending beyond the first portion of the delivery sheath and configured to hold (carry) the electrode lead wire. The first portion may comprise the side opening. In this example, when the delivery device is rotated, the electrode lead wire can pass through the side opening. Thereby, it becomes easier to prevent the first portion of the delivery sheath from pulling the electrode lead wire when the delivery sheath is rotated.

[0047] In some examples, the method may include pulling the second portion of the delivery sheath to embed the electrode lead wire, rotating the delivery device, and embedding the housing portion such that an angle and / or a different depth within the patient's tissue is different from the electrode lead wire.

[0048] In some examples, the method may further include pushing the housing portion out of the delivery sheath after rotating the delivery device such that the housing portion is embedded in a direction different from the electrode lead wire.

[0049] In some examples, the medical implant may be a nerve stimulation implant configured to stimulate a patient's nerve. In other examples, the medical implant may be a diagnostic implant (particularly, a diagnostic implant operable to detect nerve signals). In other examples, the diagnostic implant may detect one or more patient 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.)). In some examples, the medical implant may include a motion sensor or accelerometer for detecting a patient's movement.

[0050] In some examples, the medical implant may include a wireless power receiver and a wireless power transmitter. The medical implant may be operable as a wireless power relay for wirelessly powering another medical implant.

[0051] According to a fourth aspect of the present disclosure, there is provided a medical implant (e.g., a nerve stimulation implant or a diagnostic implant), the medical implant including a housing portion, an electrode lead wire extending from the housing portion and having one or more electrodes, and an antenna extending from the housing portion.

[0052] In some examples, the antenna is a flexible antenna having flexibility. The antenna may be composed of a helical antenna extending within a flexible material or a flexible sheath, or a coil antenna. In some examples, the tip of the antenna may be pointed. When deployed, the antenna can pass through the patient's tissue while cutting it. In some examples, the antenna is an antenna for wireless power reception (for a wireless power receiver) and / or an antenna for wireless communication. Therefore, the antenna can be implanted at an angle (inclination) or orientation different from that of the housing portion of the medical implant. This makes it possible to implant the antenna in an orientation advantageous for wireless power transmission and / or wireless communication with an external device.

[0053] In some examples, the antenna is one arm of a multi-pole antenna (e.g., a dipole antenna). The other arm of the dipole antenna may be housed within the housing portion and / or within the electrode lead wire.

[0054] According to a fifth aspect of the present disclosure, there is provided a delivery device for percutaneously delivering a medical implant to a patient's tissue, the medical implant comprising an elongated housing portion and a flexible antenna extending from a side surface of the housing portion, the delivery device comprising: a delivery sheath for percutaneously implanting the medical implant into the patient's tissue, the delivery sheath comprising a lumen configured to hold the housing portion of the medical implant, a guide channel formed along a side surface of the delivery sheath to hold the flexible antenna, and a slot extending from the guide channel to the lumen.

[0055] In some examples, the delivery device may further comprise a pusher operable to push the housing portion through the lumen of the delivery sheath.

[0056] In some examples, the guide channel may include a deflector configured to deflect the flexible antenna in a direction away from the delivery sheath when the medical implant is pushed through the lumen of the delivery sheath.

[0057] In some examples, the delivery device may further include a flexible sheath slidably disposed within the guide channel and operable to deploy laterally while holding the flexible antenna. The flexible sheath may be configured to partially surround the antenna. The flexible sheath may be deflected by a deflector within the guide channel or may have a shape memory function. The flexible sheath may have a sharp tip for cutting into the patient's tissue when the antenna is deployed.

[0058] According to another aspect of the present invention, there is provided a method for percutaneously implanting a medical implant into a patient's tissue, the medical implant comprising a housing portion and a flexible elongated electrode lead extending from the housing portion, the method comprising the steps of providing a delivery device having a delivery sheath for holding the medical implant, percutaneously disposing the delivery sheath in the vicinity of a target nerve of the patient, implanting the electrode lead from the delivery sheath such that the electrode lead is positioned in the vicinity of the target nerve, rotating the delivery sheath such that the housing portion is non-parallel to the electrode lead, and implanting the housing portion from the delivery sheath so as to implant the housing portion at an angle different from that of the electrode lead.

[0059] In some examples, the step of rotating the delivery sheath may include rotating the delivery sheath toward the patient's skin at an angle such that the angle of the housing portion with respect to the patient's skin is smaller than that of the electrode lead wire, so that the housing portion is implanted. In some examples, the housing portion may be implanted parallel or substantially parallel to the patient's skin. In some examples, at least a portion of the electrode lead wire may extend away from the skin at an angle, for example, up to about 45 degrees from the normal of the skin surface, toward the target nerve in the patient's tissue.

[0060] In some examples, the delivery sheath may include a first needle that holds the housing portion and a second needle that holds the electrode lead wire. In such an example, the second needle may be retractable relative to the first needle. The method may include the step of retracting the second needle to implant the electrode lead wire.

[0061] In some examples, the first needle may include a side opening. In such an example, when the delivery sheath is rotated during use, a portion of the electrode lead wire may pass through the side opening. Thereby, the electrode lead wire can be prevented from being pulled and the tension of the electrode lead wire can be reduced, and the electrode lead wire can be prevented from moving from the implantation position.

[0062] In some examples, when the delivery sheath is rotated, the first needle can be percutaneously positioned. That is, while the delivery sheath is rotated, the tip of the first needle can be positioned under the skin. For example, while the delivery sheath is rotated, the tip of the first needle can be positioned within the subcutaneous tissue (e.g., fascia). Advantageously, only one puncture wound is formed in the patient's skin.

[0063] In other examples, even if the delivery sheath is rotated, the first needle is not placed percutaneously. In some examples, in the method, when the second needle is retracted, the first needle is placed percutaneously, and the method further includes pulling out the first needle from a non-percutaneous position before rotation of the delivery sheath, and reinserting the first needle into the patient's tissue before implantation of the housing portion.

Brief Description of the Drawings

[0064] Embodiments of the present invention are further described with reference to the following attached drawings.

[0065]

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DETAILED DESCRIPTION OF THE INVENTION

[0066] FIG. 1 schematically shows a medical implant 1. In some examples, the medical implant 1 may be a nerve implant (e.g., a nerve stimulation implant or a diagnostic implant). The medical implant 1 includes a housing portion 2 and an elongated electrode lead 3. The housing portion 2 houses electronic components (electronic devices) of the medical implant 1 (e.g., a printed circuit board, a wireless communication receiver and a wireless communication transmitter, and / or sensor electronic devices) as described below. 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.

[0067] As shown in the figure, a wireless power receiver 35 is provided in the housing portion 2. The wireless power receiver 35 may be composed of an antenna receiver (power receiving unit) (for example, a coil), or may be composed of a conductive portion of the housing portion 2. The wireless power receiver 35 is configured to be wirelessly connected to an external device so as to receive wireless power, as will be further described below.

[0068] 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 an electronic component within the housing portion 2.

[0069] 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 30 millimeters or less (for example, 20 millimeters or less, for example, 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 200 millimeters or less (for example, 150 millimeters or less, 100 millimeters or less, 50 millimeters or less), for example, about 50 millimeters. In some examples, the length of the electrode lead wire 3 may be from about 100 millimeters to about 200 millimeters. However, it will be understood that the dimensions of the housing portion 2 correspond to the size of the electronic components housed in the housing portion 2, and the length of the electrode lead wire 3 corresponds to the anatomical structure around the target nerve, so that a shorter or longer electrode lead wire 3 may be appropriate depending on the depth of the nerve in the muscle tissue.

[0070] As further described below, the medical implant 1 is implantable within a patient's body and operable to detect and / or stimulate nerves or the patient's tissue. In some examples, the medical implant 1 is implantable to detect and / or stimulate the hypoglossal nerve (particularly, the medial and / or distal branches of the hypoglossal nerve). In some examples, the medical implant 1 is implantable to detect and / or stimulate cervical nerves. By stimulating the hypoglossal nerve and / or cervical nerve snares, treatment of sleep apnea may be provided. In other examples, the medical implant 1 is implantable to detect and / or stimulate the greater occipital nerve, although the same or similar implants may be implantable to detect and / or stimulate other nerves (particularly, other peripheral nerves in 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 (e.g., to treat urinary incontinence), or the vagus nerve (e.g., to regulate pancreatic juice secretion).

[0071] Figure 2 shows the medical implant 1 implanted in a patient. The medical implant 1 is disposed beneath the surface of the skin 5 (particularly, beneath the epidermis). The housing portion 2 may be disposed in the dermis 6 or the subcutaneous tissue 7. Disposing the housing portion 2 in the subcutaneous tissue 7 can reduce damage and irritation to the patient.

[0072] As shown, the electrode lead 3 extends from the housing portion 2 through the underlying tissue (particularly, the muscle 8) to a position adjacent (peripheral) to the target nerve 9. The electrode lead 3 is arranged such that the electrode 4 (see Figure 1) contacts or is in proximity to the nerve 9. This enables the nerve 9 to be detected and / or stimulated using the electrode 4.

[0073] The medical implant 1 may include one or more anti-displacement members. The anti-displacement members may be provided on the housing portion 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.

[0074] In some examples, the medical implant 1 is battery-less and does not have an integrated power source. The external device 32 can wirelessly power the medical implant 1 via the wireless power receiver 35 shown in FIG. 1. The external device 32 can further wirelessly communicate with the medical implant 1 (particularly, the electronic components within the housing portion 2). The medical implant 1 may include a wireless communication receiver / wireless communication transmitter for communicating with the external device 32. The medical implant 1 may have a processor or a controller configured to operate the medical implant 1. The external device 32 may be disposed on the skin adjacent to (the periphery of) the medical implant 1. The external device 32 may be attached to the skin adjacent to (the periphery of) the medical implant 1. The external device 32 may be a wearable device.

[0075] In some examples, the medical implant 1 is a nerve stimulation implant. The medical implant 1 can be implanted targeting a specific nerve or nerve group (e.g., the greater occipital nerve).

[0076] During operation, an electrical signal such as a current is supplied to the electrode 4 of the nerve stimulation implant to stimulate the nerve. In some examples, the electrical signal may be a voltage-controlled stimulation. Such stimulation can bring about the alleviation of chronic pain (e.g., occipital neuralgia, intractable migraine, etc.) and / or other therapeutic effects. In various examples, the nerve stimulation implant may target specific deep subcortical cortex, spinal cord, skull, and peripheral nerve structures to treat the patient's pain. Nerve stimulation therapy is an alternative to analgesics and nerve block injections. It has fewer side effects than many drugs and can reduce the possibility of drug dependence.

[0077] In other examples, the 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 an example, the 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). The nerve diagnostic implant 1 may target the same nerve as described above for the nerve stimulation implant 1.

[0078] In other examples, the diagnostic implant 1 may additionally or alternatively detect one or more patient 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.)).

[0079] Figures 3A and 3B show an alternative medical implant 1 for use in combination with another medical implant 73. The other medical implant 73 may be a deep tissue implant (e.g., a pacemaker). In these examples, the medical implant 1 can function as a wireless power receiver or a wireless power relay for the other medical implant 73. In the example of FIG. 3A, the medical implant 1 can be connected to another medical implant 73 by a wire 74. The medical implant 1 includes a wireless power receiver 35 as described above and transmits power to another medical implant 73 via the wire 74. The medical implant 1 can be implanted at a shallower position within the tissue than the other medical implant 73. Therefore, the wireless power coupling is improved by reducing the distance from an external wireless power transmitter. In the example of FIG. 3B, the medical implant 1 includes a wireless power receiver 35 and a wireless power transmitter 75 and is configured to relay power to a wireless power receiver 76 of another medical implant 73. The wireless power transmitter 75 of the medical implant 1 may be connected to the housing portion 2 by a wire 77 as shown, or may be provided within the housing portion 2 so that the wire 77 is omitted. Since the medical implant 1 can be implanted at a shallower position within the tissue than the other medical implant 73, the wireless power coupling is improved.

[0080] As described above, the medical implant 1 is powered by wireless power transmission (WPT) from an external device 32. The efficiency of wireless power transmission (WPT) depends on the proximity of the medical implant 1 to the wireless power transmitter of the external device 32. Also, the efficiency of wireless power transmission (WPT) is affected by the orientation of the medical implant with respect to the wireless power transmitter, and even a slight movement can impair the wireless power transmission (WPT) or reduce its efficiency.

[0081] In some examples, the medical implant 1 includes an internal battery. The internal battery can be recharged by wireless power transfer in the same manner as described above. In such cases, the external device 32 may be used periodically to charge the medical implant 1.

[0082] The description of the wireless power receiver 35 of the medical implant 1 relates to an electrically small antenna, where the physical size of the antenna here means that it is smaller than the wavelength of the operating frequency. Considering this, the terms near-field, mid-field, and far-field can be considered as different operating regions depending on the operating frequency and the distance between the transmitter antenna and the receiver antenna. When the distance between the transmitter antenna and the receiver antenna is less than one wavelength of the operating frequency, it is considered a near-field. When the distance between the transmitter antenna and the receiver antenna approximates or is at the boundary of one wavelength of the operating frequency, it is considered a mid-field. When the distance between the transmitter antenna and the receiver antenna exceeds one wavelength of the operating frequency, it is considered a far-field.

[0083] The examples disclosed herein relate to a wireless power supply system, a transmitter, a receiver, a power transmission antenna, and a power reception antenna configured to enable wireless power transfer for the purpose of supplying power to a medical implant and / or recharging a battery forming part of the medical implant.

[0084] The medical implant 1 includes a wireless power receiver 35 configured to wirelessly couple with a wireless power transmitter of the external device 32. The wireless power transmitter of the external device 32 and the wireless power receiver 35 may be configured to operate in each frequency band of the ultra-high frequency band (UHF), L-band, S-band, C-band, and X-band. This means that the system is adaptable and operable over a range of 30 MHz to 12 GHz, which makes wireless power transfer more adaptable with respect to the distance between the receiver and the transmitter.

[0085] In one example, the wireless power receiver 35 is configured to receive wireless power transmitted from a wireless power transmitter over a distance of 1 cm to 10 cm. The wireless power system enables wireless power transmission over this distance, thereby enabling the wireless power system to operate in a near-field, mid-field, and far-field.

[0086] Figures 4 to 7B show the delivery device 10 (implant delivery device) of the first example. As shown in Figure 4, the delivery device 10 includes a delivery sheath. In this example, the delivery sheath includes 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. In particular, the diameter of the second needle 13 is smaller than the diameter of the first needle 12.

[0087] During use, the housing portion 2 is received within the first needle 12 (in particular, the lumen of the first needle 12). During use, the electrode lead wire 3 is received within the second needle 13 (in particular, 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 Figure 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, during use, the medical implant 1 is received within the first needle 12 and the second needle 13 of the delivery device 10.

[0088] As shown in FIG. 4, the first needle 12 and the second needle 13 are offset when viewed axially. 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 (specifically, the lumen of the first needle 12), and the second needle 13 is partially housed within the first needle 12 along the housing portion 2.

[0089] Referring to FIG. 6, the second needle 13 has a slot 18 (opening). Thereby, as shown in FIG. 4, a part of the electrode lead wire 3 can extend from the second needle 13 and be connected to the housing portion 2. As will be further described later, the slot 18 may extend to the tip 15 of the second needle 13.

[0090] In some examples, the second needle 13 may include a sheath having an opening that extends along one side surface over the entire length or substantially the entire length.

[0091] As will be described in more detail below, during use, both the first needle 12 and the second needle 13 penetrate the patient's skin, whereby the housing portion 2 of the medical implant 1 is disposed at a first depth within the patient, and the electrode lead wire 3 is disposed at a second depth. Subsequently, the delivery device 10 releases the medical implant 1 and implants (deploys) the medical implant 1 so as to leave it in the position shown in FIG. 2. The tip 14 of the first needle 12 and the tip 15 of the second needle 13 are each sharp tips configured to pierce the patient's skin and penetrate the tissue to percutaneously dispose 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.

[0092] In some examples, the gauge of the first needle 12 may be between 6 gauge and 15 gauge, for example, 10 gauge. In some examples, the gauge of the second needle 13 may be between 15 gauge and 25 gauge, for example, 20 gauge.

[0093] In some examples, the second needle 13 is retractable (storable) relative to the first needle 12 for deploying (unfolding) the electrode lead wire 3. A slot 18 (see FIG. 6) along the second needle 13 enables the deployment (unfolding) of the electrode lead wire 3 when the second needle 13 is retracted.

[0094] In some examples, the housing portion 2 is detachably attached to the first needle 12 (or another part of the delivery device 10) and is released (set free) before deployment (unfolding).

[0095] 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 portion 2 away from the first needle 12, the housing portion 2 can be deployed (unfolded) from the first needle 12. In other examples, the delivery device 10 may include a deployment member (implantation member) (e.g., a pusher) configured to push the housing portion 2 out of the first needle 12 to deploy (unfold) the housing portion 2 at an appropriate anatomical site.

[0096] FIGS. 5A - 5C illustrate the operation of the delivery device 10.

[0097] As shown, the exemplary implant delivery device (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.

[0098] 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 the tip 15. In particular, the actuating tab 16 may be a grip handle or the like for an operator to grip.

[0099] The second needle 13 is a retractable part (storage part) that can be retracted (stored) with respect to the first needle 12. In particular, the second needle 13 can slide from the position shown in FIG. 5A to the position shown in FIG. 5B through the first needle 12 and the handle 11. In this example, by pulling the actuating tab 16 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 wire 3 is placed. The opening (slot 18) (see FIG. 6) along the second needle 13 provides a connection portion between the electrode lead wire 3 and the housing portion 2. The opening (slot 18) extends to the tip 15 of the second needle 13.

[0100] 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 provided on the actuating tab 16 or in the vicinity (adjacent portion) thereof, 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).

[0101] 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.

[0102] 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 further pushed in, 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 in 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 percutaneous delivery of the medical implant 1 into the patient's tissue.

[0103] In some instances, 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.

[0104] Once the delivery device 10 is positioned at a predetermined location, the tip 15 of the second needle 13 (and the electrode lead wire 3 within the second needle 13) is positioned near the nerve, and the tip 14 of the first needle 12 (and the housing portion 2 within the first needle 12) is positioned 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. 1). Thereby, the position of the electrode 4 can be inspected. If necessary, the second needle 13 can be extended again to the position shown in FIG. 5A and repositioned.

[0105] Once the electrode lead wire 3 is properly positioned, the second needle 13 is retracted to the position shown in FIG. 5B and the electrode lead wire 3 is left in place.

[0106] The second needle 13 is retracted by pulling the actuating tab 16 with respect to the handle 11 so as to release the lock of the locking device 17 (locking mechanism) and slide the second needle 13 to the retracted position (stored position) shown in FIG. 5B. The actuating 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, when the second needle 13 is retracted, the electrode lead wire 3 is left in place and is exposed to the surrounding tissue (and nerve).

[0107] Next, as shown in FIG. 5C, the delivery device 10 is withdrawn from the patient's body and the housing portion 2 is left in 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 a predetermined position 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 in the first needle 12.

[0108] In other examples, the delivery device 10 may include a deployment member (e.g., a pusher within the first needle 12) configured to push the housing portion 2 out of the first needle 12. In some examples, the delivery device 10 may have a retaining member configured to removably attach the housing portion 2 to the first needle 12 and / or the handle 11. The retaining member may release the housing portion 2 after the second needle 13 is retracted and before the first needle 12 is removed from the patient's body. In some examples, the retaining member may be electrically coupled to the medical implant 1 (particularly, the housing portion 2). The electrical coupling may supply power to the medical implant 1 when the medical implant 1 is within the delivery device 10.

[0109] In other examples, the medical implant 1 may include one or more anti-displacement mechanisms (anti-migration mechanisms, anti-movement mechanisms). For example, the electrode lead wire 3 may include one or more anti-displacement mechanisms configured to fix the electrode lead wire 3 (and the medical implant 1) when the second needle 13 is retracted.

[0110] 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 received within the second needle 13, and the second needle 13 has a slot 18 for connecting the electrode lead wire 3 to the housing portion 2 within the first needle 12. The slot 18 extends partially along the second needle 13 from the tip 15 and may extend over most or all of the length of the second needle 13. The second needle 13 may have a sheath shape. The first needle 12 houses the housing portion 2.

[0111] 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 to penetrate the patient's skin and tissue during use.

[0112] As shown in FIG. 6, the second needle 13 extends through the lumen of the first needle 12. In particular, as shown in FIG. 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.

[0113] The first portion 19A is formed in a shape capable of accommodating the housing portion 2. In particular, the first portion 19A has a size capable of accommodating the housing portion 2 and has a substantially circular cross-section that holds the housing portion 2 in an axially aligned state within the first portion 19A.

[0114] The second portion 19B is formed in a shape capable of accommodating the second needle 13. In particular, the second portion 19B has a size capable of accommodating the second needle , and has a substantially circular cross-section that holds the second needle 13 in an axially aligned state within the second portion 19B.

[0115] In some examples, the second portion 19B and the first portion 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 portion 19B can cause the housing portion 2 to be pushed out to one side of the first portion 19A.

[0116] The slot 18 of the second needle 13 is open toward the center of the first needle 12. Thereby, as shown in FIG. 6, the electrode lead wire 3 can be connected to the housing portion 2.

[0117] Therefore, the first needle 12 has a shape that can accommodate the housing portion 2 and the second needle 13, and has a shape that allows the second needle 13 to slide toward the retracted position. The positioning of the second needle 13 within the lumen of the first needle 12 is advantageous in that, during use, the puncture wound formed by the second needle 13 is enlarged by the first needle 12, and only one puncture wound is formed on the patient's skin.

[0118] 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).

[0119] Figures 8A - 8C show an example of the second needle 13 and the electrode lead wire 3, and in particular, show a configuration in which the electrode lead wire 3 is held within the second needle 13. Figures 8A - 8C show cross - sections of the electrode lead wire 3 and the second needle 13. As described above, the second needle 13 includes a slot 18 that allows the second needle 13 to be retracted relative to the first needle 12.

[0120] As shown in Figure 8A, in the first example, the second needle 13 surrounds more than half of the electrode lead wire 3. That is, the slot 18 of the second needle 13 extends circumferentially over an angular range of less than 180 degrees (preferably less than about 160 degrees, more preferably less than about 140 degrees) around the second needle 13. In some examples, the slot 18 extends circumferentially around the second needle 13 over an angular range of at least 90 degrees. In some examples, the slot 18 extends circumferentially around the second needle 13 over an angular range of about 100 degrees to about 150 degrees. Thereby, the electrode lead wire 3 is held within the lumen of the second needle 13.

[0121] Preferably, the electrode lead wire 3 can pass through the slot 18 by being pushed or pulled. The dimensions of the slot 18 with respect to the electrode lead wire 3 are set so that the electrode lead wire 3 can be incorporated into the second needle 13 by pushing the electrode lead wire 3 through the slot 18. The electrode lead wire 3 and / or the second needle 13 may be deformed so that the electrode lead wire 3 can pass through the slot 18.

[0122] As shown in FIG. 8B, in some examples, the second needle 13 may include recesses or grooves 308a, 308b on both side portions on the inner surface of the second needle 13. The electrode lead wire 3 may include protrusions or ridges 309a, 309b corresponding to the recesses or grooves 308a, 308b. The protrusions or ridges 309a, 309b engage with the grooves 308a, 308b to hold the electrode lead wire 3 within the second needle 13. The recesses or grooves 308a, 308b extend along the length of the second needle 13, and the second needle 13 is slidable relative to the electrode lead wire 3. The protrusions or ridges 309a, 309b may extend at least partially along the length of the electrode lead wire 3.

[0123] As shown in FIG. 8C, in some examples, the electrode lead wire 3 includes protrusions or ridges 310a, 310b that extend (project) from the side surface of the electrode lead wire 3 and are received inside the inner diameter (inner surface) of the second needle 13. The protrusions or ridges 310a, 310b may extend at least partially along the length of the electrode lead wire 3. Thereby, the protrusions or ridges 310a, 310b function to hold the electrode lead wire 3 within the lumen of the second needle 13. The electrode lead wire 3 can be removed from the second needle 13 by rotating the electrode lead wire 3 within the lumen of the second needle 13 until one of the protrusions or ridges 310a, 310b is aligned with the slot 18. Thereby, the electrode lead wire 3 can be removed through the slot 18 (e.g., by pulling out the electrode lead wire 3). Similarly, the electrode lead wire 3 can be inserted into the second needle 13 by aligning one of the protrusions or ridges 310a, 310b with the slot 18 and pushing the electrode lead wire 3 through the slot 18.

[0124] In some examples, the electrode lead 3 may include raised portions 309a, 309b, 310a, 310b as shown in FIGS. 8B and 8C, the second needle may include grooves 308a, 308b as shown in FIG. 8B, and the slot 18 may extend circumferentially around the second needle 13 over an angular range of about 180 degrees. Thereby, the raised portions 309a, 309b, 310a, 310b function to hold the electrode lead 3 within the second needle 13, and the electrode lead 3 can be easily inserted into and removed from the second needle 13 via the slot 18. In the above example, the second needle 13 is initially in the extended position (elongated position), and the first needle 12 and the second needle 13 can be simultaneously placed within the patient's body.

[0125] FIG. 9 shows another example where the second needle 13 is initially in the retracted position. In this example, as shown, the actuation 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 3 is partially within the second needle 13 and is looped between the housing portion 2 and the second needle 13.

[0126] During implantation, when the first needle 12 is inserted into the patient's body using the delivery device 10 in the configuration shown in FIG. 9, the actuation tab 16 is then pushed towards the handle 11, causing the second needle 13 to extend beyond the first needle 12 and carry the electrode lead 3 to a predetermined position. At this position, the lock device 17 (locking mechanism) can be engaged to lock the actuation tab 16 and the second needle 13 in place.

[0127] In some examples, the delivery device 10 may be removed from the patient with the second needle 13 in the extended position, and a deployment 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 extends, the second needle 13 is retracted by pulling the actuation tab 16 away from the handle 11 in the manner described above with reference to FIGS. 5A-5C, whereby the electrode lead 3 and the housing portion 2 are released.

[0128] FIG. 10 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 actuation tab 16 is configured to be pushed toward the handle 11 (and the patient) to retract the second needle 13.

[0129] In particular, as shown, the delivery device 10 includes a rack and pinion mechanism. The rack and pinion mechanism converts the movement of the actuation tab 16 toward the handle 11 into retraction of the second needle 13 (i.e., moves the second needle 13 in a direction opposite to the actuation tab 16).

[0130] As shown in FIG. 10, 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 a 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 operating tab 16 or is formed as a part of the operating tab 16. The pinion gear 31 is rotatably attached 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 attached within the first needle 12 or, as shown, may be attached behind the end of the first needle 12 within the handle 11. Thus, when the operating tab 16 is pushed toward the patient, the rack and pinion mechanism pulls the second needle 13 away from the patient to release the electrode lead wire 3. When the operating tab 16 is pushed toward the handle 11, the end of the second rack portion 30B engages the housing portion 2 and can push the housing portion 2 out of the first needle 12. Thus, the second rack portion 30B may be a deployment member (retention member).

[0131] Advantageously, the delivery device 10 can be operated with one hand by pushing the operating tab 16 rather than pulling it.

[0132] FIGS. 11A and 11B show a medical implant 1 implanted (deployed) in a first configuration and a second configuration, respectively. In these configurations, the housing portion 2 is oriented such that the power receiving direction is toward the surface of the skin 5 (i.e., the epidermis), and the electrode lead wire 3 extends along a direction different from the longitudinal axis 48 of the housing portion 2 toward the nerve 9.

[0133] For example, when an external device 32 (see FIG. 20) equipped with a wireless power supply transmitter is placed on the skin at the implantation site, the wireless power supply transmitter can transmit power most efficiently in the power transmission direction 50, which is the direction perpendicular to the skin surface. As shown in FIGS. 11A and 11B, since the electrode lead wire 3 needs to be close to the nerve 9 to be stimulated, it is generally placed (deployed) at a position deeper than the housing portion 2, and the housing portion 2 needs to be close to the skin surface for wireless power supply coupling, so it is usually implanted in the subcutaneous tissue 7 of the patient.

[0134] In the first form shown in FIG. 11A, the housing portion 2 is placed (deployed) such that its longitudinal axis 48 is substantially parallel to the power transmission direction 50 (usually the normal axis to the skin surface at the implantation site) of the wireless power supply transmitter of the external device 32 (see FIG. 20). In the second form shown in FIG. 11B, the housing portion 2 is placed (deployed) such that its longitudinal axis 48 is inclined at an acute angle with respect to the power transmission direction 50 (for example, the normal axis) at the implantation site.

[0135] The wireless power supply receiver of the medical implant 1 may have a power receiving direction (the direction of the wireless power supply receiver in which wireless power supply is transmitted most efficiently). If the power receiving direction is perpendicular to the longitudinal axis 48 of the housing portion 2 (the power receiving direction is about 90 degrees with respect to the power transmission direction), compared with the first form, in the second form, since the angle between the power receiving direction and the power transmission direction 50 becomes smaller, the power loss becomes smaller compared with the first form. In the second form, compared with the first form, since the angle between the power receiving direction and the power transmission direction 50 becomes smaller, in the second form, the power coupling between the wireless power supply receiver and the wireless power supply transmitter becomes more efficient.

[0136] In the embodiment, since the housing portion 2 is placed (deployed) such that the longitudinal axis 48 of the housing portion 2 is parallel to the skin surface (that is, the power receiving direction is parallel to the power transmission direction), particularly efficient power coupling is provided.

[0137] As shown in FIGS. 2, 11A, and 11B, in various examples, the electrode lead wire 3 is embedded at an angle (tilted) with respect to the skin 5 (skin surface). This may be necessary to avoid anatomical features or simply to reach a desired implantation site. However, such an angle of the electrode lead wire 3 may not correspond to an efficient orientation of the housing portion 2 with respect to the external device 32 (see FIG. 20) and the wireless power supply transmitter and the wireless power supply receiver 35 as shown in FIG. 1. Thus, as will be described variously below, the operator can embed the electrode lead wire 3 and the housing portion 2 at different angles, whereby the wireless power supply receiver 35 (see FIG. 1) is directed towards the skin 5 and thus also towards the external device 32 (see FIG. 20).

[0138] By using the delivery device described above in connection with FIGS. 1-10, the operator can retract the second needle 13 (which initially houses the electrode lead wire 3), rotate the delivery device 10 so that the housing portion 2 is oriented in a desired direction with respect to the skin surface, and implant (deploy) the medical implant 1 with the housing portion 2 angled (tilted) with respect to the electrode lead wire 3, for example, by using the pusher 40 as described above to deploy the housing portion 2 from the delivery device 10.

[0139] In some examples, the electrode lead wire 3 is embedded so as to extend into the patient's tissue (particularly, in the vicinity of the target nerve). The housing portion 2 can be embedded at an angle (tilt) different from that of the electrode lead wire 3. As shown in FIGS. 1-3B, the housing portion 2 is formed in an elongated shape and can be embedded so as to extend substantially parallel to the surface of the patient's skin 5. In other examples, the elongated housing portion 2 may be substantially perpendicular to the surface of the skin 5.

[0140] Figures 12 to 19E show delivery devices 100, 200 of another example in which the medical implant 1 can be implanted (deployed) such that the housing portion 2 is angled (tilted) with respect to the electrode lead wire 3. One or more of the components (parts) described above in connection with the delivery device 10 shown in FIGS. 1 to 10 can be used in any of the delivery devices 100, 200 shown in FIGS. 12 to 19E.

[0141] FIG. 12 shows a delivery device 100 of an example in which the medical implant 1 can be implanted (deployed) in a manner different from the manner described above in connection with the delivery device 10 shown in FIGS. 1 to 10.

[0142] The delivery device 100 of FIG. 12 includes a handle 11 and a delivery sheath. In this example, the delivery sheath has 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 in the delivery device 100 have substantially the same configuration as those described above, and the specific features of the first needle 12 and the second needle 13 will not be repeatedly described here. The first needle 12 shown in FIG. 12 includes a side wall 42 in which a side opening 44 is formed. The side opening 44 may extend to the tip of the first needle 12, and in some examples, may extend along the length of the first needle 12. The side opening 44 enables a part or all of the medical implant 1 to be discharged from the side opening 44 in a direction not parallel to the axial direction of the first needle 12, as will be described below. It is obvious that a similar side opening 44 may be provided in the exemplary delivery device 10 described above in connection with FIGS. 1 to 10.

[0143] In the example shown in FIG. 12 , the delivery device 100 includes a deployment member (e.g., including a pusher 40). The deployment member is configured to push the housing portion 2 of the medical implant 1 out of the first needle 12 through a side opening 44 in the side wall 42. The deployment member may be deployed in the manner described above. When the pusher 40 first contacts the housing portion 2, the housing portion 2 is aligned with the axial direction of the first needle 12. As the pusher 40 presses against the housing portion 2, the housing portion 2 is rotated relative to the first needle 12, for example, to an angle perpendicular to the first needle 12, as shown in FIGS. 12 and 13 . The first needle 12 may include one or more guides 46 or pivot points (pivot axes) to facilitate rotation of the housing portion 2.

[0144] Additionally or alternatively, the pusher 40 itself may be configured to facilitate rotation of the housing portion 2, for example, by having an end portion with a tapered cross section, so that the pusher 40 can also act as a wedge, forcing the housing portion 2 to rotate in a predetermined direction (e.g., towards the side opening 44).

[0145] As the pusher 40 continues to push the housing portion 2, it will eventually be ejected from the first needle 12. The second needle 13 may then be retracted to deploy the electrode lead 3 as described above. It will be apparent that the physician may rotate the delivery device 100 to orient the housing portion 2 in a desired direction after the second needle 13 is retracted and before the housing portion 2 is ejected from the first needle 12. In this manner, the delivery device itself does not need to rotate the housing portion 2 to its final orientation before the housing portion 2 is ejected from the first needle 12.

[0146] FIG. 13 shows the housing portion 2 in a position rotated with respect to the axial direction of the first needle 12. In some examples, the housing portion 2 includes a wireless power receiving device (power receiving unit) configured to receive power in the power receiving direction. The power receiving direction may be perpendicular to the longitudinal axis 48 of the housing portion 2. A separate antenna receiver is not essential, and in some cases, the housing portion 2 itself may be formed as a power receiving unit having a power receiving direction. In particular, the casing (housing) of the housing portion 2 may have conductivity and may be configured to function as an antenna receiver (power receiving unit). In some examples, wireless power supply to components within the housing portion 2 may be performed through a wireless power transmission window formed in the housing portion 2. When there is a wireless power transmission window, it is preferable to place (deploy) the housing portion 2 such that the wireless power transmission window is directed toward the patient's skin at the implantation site.

[0147] When the power receiving direction does not coincide with the power transmission direction of the external device 32 (see FIG. 20), power loss due to wireless power supply coupling occurs. Therefore, it is desirable that the medical implant 1 can be placed (deployed) such that the housing portion 2 is directed in a direction different from the electrode lead wire 3.

[0148] FIG. 14 shows a second example of a delivery device 100 having a side opening 44. The delivery device 100 shown in FIG. 14 is different from the delivery device 100 shown in FIG. 12 in that the delivery sheath includes a cannula 50 instead of the first needle 12 and the second needle 13. The medical implant 1 (2, 3) is housed within the cannula 50 that is percutaneously placed during implantation. When the cannula 50 is percutaneously placed, the pusher 40 pushes the medical implant 1 (2, 3) out of the cannula 50. While the pusher 40 is pushing the medical implant 1 (2, 3) out of the cannula 50, the cannula 50 can be simultaneously withdrawn.

[0149] The cannula 50 includes a side wall 52 formed with a side opening 44 so as to be able to discharge the housing portion 2 in the manner described above with reference to FIGS. 12 and 13. The side opening 44 preferably extends to the tip of the cannula 50 so that the electrode lead wire 3 can pass through the side opening 44. In some examples, the side opening 44 may extend along the length of the cannula 50. It is obvious that the side opening 44 may have different widths along the length of the cannula 50 (depending on the longitudinal position). For example, the width of the side opening 44 may be wider at the proximal portion of the cannula 50 where it is necessary to accommodate the housing portion 2, but may be narrower at the distal portion where it is necessary to accommodate the electrode lead wire 3. Thereby, when the cannula 50 is retracted, the electrode lead wire 3 can be deployed, and when the pusher 40 is pushed in, the housing portion 2 can be discharged from the side opening 44 so that the power receiving direction is directed toward the skin surface. The illustrated cannula 50 includes one or more guides 46 or pivot points (pivot axes) that facilitate rotation of the housing portion 2. Similar to the example of FIG. 12, the pusher 40 is also shaped to facilitate rotation of the housing portion 2, and the above description regarding the pusher 40 also applies to FIG. 14 in the same manner.

[0150] FIG. 15 shows a third example of a delivery device 100 provided with a side opening 44. The delivery device 100 shown in FIG. 15 is different from the delivery device 100 shown in FIG. 12 in that the delivery sheath includes a single needle 12. The needle 12 has substantially the same features as the cannula 50 of the delivery device 100 shown in FIG. 13, and the above description regarding the same features also applies to the delivery device 100 shown in FIG. 15 in the same manner. The needle 12 of the example of FIG. 15 may have a beveled tip, which enables the needle 12 to pierce the patient's skin and tissue without the need for an incision.

[0151] FIG. 16 shows a fourth example of a delivery device 100 with a side opening 44. The delivery device 100 shown in FIG. 16 has a delivery sheath formed from a first portion 47 and a second portion 48. The first portion 47 is sized to accommodate the housing portion 2, and the second portion 48 extends from and is fixed to the first portion 47. The first portion 47 includes a side opening 44. The side opening 44 may extend to the junction of the first portion 47 and the second portion 48, and in some examples, may extend along the length of the first portion 47. The side opening 44 may extend into the second portion 48 and optionally may extend to the tip of the second portion 48. The second portion 48 has a smaller diameter than the first portion 47 and holds the electrode lead wire 3. A tapered portion 49 joins the first portion 47 and the second portion 48. The tapered portion 49 may have a shape that guides the housing portion 2 to be discharged from the side opening 44 in the first portion 47. When the housing portion 2 is pushed in by the pusher 40, the tapered portion 49 of the delivery sheath advantageously rotates the housing portion 2 so that the housing portion 2 slides outwards from the side opening 44. The guide 46 described with reference to FIGS. 13 and 14 may be additionally provided to guide and rotate the housing portion 2 as described above. In some cases, the guide 46 may be omitted.

[0152] FIG. 17 shows a fifth example of a delivery device 100 having a side opening 44. In this example, the delivery device 100 has a delivery sheath with a first needle 12 and a second needle 13 that is movable relative to the first needle 12 (specifically, extendable and retractable), in the same manner as described with reference to FIGS. 4-10. In this example, the second needle 13 is initially retracted relative to the first needle 12. Thereby, before the electrode lead 3 is deployed (extended), the first needle 12 can puncture the skin to deploy the housing portion 2. The housing portion 2 is deployed (extended) via the pusher 40 as described above. When the housing portion 2 is deployed in a desired direction, the second needle 13 can be extended so as to place the electrode lead 3 near the nerve 9. When the second needle 13 extends deeper into the tissue toward the nerve 9, the opening formed in the second needle 13 as described above allows the electrode lead 3 to pass through the second needle 13. The side opening 44 in the side wall of the first needle 12 may extend to the distal end of the first needle 12, but this is not essential. The side opening 44 may extend along the length of the first needle 12. When the electrode lead 3 is placed in a predetermined position, the second needle 13 can be withdrawn to deploy (extend) the electrode lead 3.

[0153] FIGS. 18A and 18B show another example of a delivery device 200. In this example, the delivery device 200 has a handle 11 and a delivery sheath. In this example, the delivery sheath has 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 in the delivery device 200 have substantially the same configuration as that described above with reference to FIG. 10.

[0154] In particular, the delivery device 200 includes a rack and pinion mechanism similar to that described with reference to FIG. 10. The rack and pinion mechanism includes a first rack portion 30A that is attached to the second needle 13 or formed as part of the second needle 13. The rack and pinion mechanism also includes a second rack portion 30B that is attached to the actuating tab 16 or 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 wire 3. When the actuating tab 16 is pushed toward the handle 11, the end of the second rack portion 30B engages the housing portion 2 and can push the housing portion 2 out of the first needle 12. Thus, the second rack portion 30B can be a deployment member (retention member).

[0155] Advantageously, the delivery device 200 can be operated with one hand by pushing the actuating tab 16 rather than pulling it.

[0156] As shown in FIGS. 18A and 18B, in this example, prior to use, the electrode lead wire 3 extends from the end of the housing portion 2 facing the handle 11. The electrode lead wire 3 is routed within the first needle 12 over the housing portion 2 and into the second needle 13. A portion of the electrode lead wire 3 is disposed within the first needle 12 parallel to the housing portion 2.

[0157] The first needle 12 has a side opening 12a, which is most clearly shown in FIG. 18B. The side opening 12a extends from the tip 14 of the first needle 12 to above the housing portion 2. This allows the side opening 12a to accommodate a portion of the electrode lead wire 3 (the portion adjacent to the housing portion 2 within the first needle 12) before use. In this example, the width of the side opening 12a is wider than the electrode lead wire 3 but narrower than the housing portion 2. This allows the housing portion 2 to be held within the first needle 12, and the electrode lead wire 3 to pass through the side opening 12a, as described below.

[0158] 19A-19E illustrate operation of the delivery device 200 of FIGS. 18A and 18B to implant the medical implant 1 into the tissue of a patient.

[0159] Before use, the delivery device 200 has the housing portion 2 disposed within the first needle 12, as shown in FIGS. 18A and 18B . The electrode lead 3 extends from the housing portion 2 toward the handle 11, then extends within the first needle 12, past the housing portion 2, and into the second needle 13. The second needle 13 is in an extended position. In this configuration, the second needle 13 is percutaneously positioned in the same manner as described with reference to FIG. 5A , thereby properly positioning the electrode lead 3 relative to the patient's target nerve. For example, the second needle 13 (and electrode lead 3) may be located near or in contact with the target nerve. An ultrasound imaging device may be used to assist in guiding the second needle 13 to the correct position.

[0160] In some examples, a guide (not shown) may be used to constrain the position and orientation of the second needle 13 during insertion into the patient. The guide is applied to or attached to the patient and has a guide channel through which the second needle 13 is threaded.

[0161] 19A, once the second needle 13 is properly positioned, the actuation tab 16 can be depressed to retract the second needle 13 relative to the first needle 12, thereby exposing and implanting the electrode lead wire 3.

[0162] In some examples, the second needle 13 may be partially retracted so as to expose the electrode 4 (see FIG. 1) on the electrode lead 3. Next, the position of the electrode 4 may be inspected to confirm that the electrode lead 3 is properly positioned. If necessary, the second needle 13 may be extended (elongated) again and repositioned. During the above inspection, the medical implant 1 may be powered when it is within the delivery device 10, for example, by providing a power supply system within the delivery device 10. The power supply system may include one or more contacts that electrically connect to the medical implant 1 and / or a wireless power transmitter within the delivery device 10 for supplying power to the medical implant 1.

[0163] If necessary, as shown in FIG. 19B, after the second needle 13 is retracted, the delivery device 200 is partially withdrawn from the patient. Thereby, the electrode lead 3 extends partially as shown. This partial retraction facilitates moving (i.e., rotating) the first needle 12 as described below.

[0164] From the position shown in FIG. 19B, by rotating the delivery device 200 relative to the patient, the orientation of the first needle 12 and the housing portion 2 with respect to the embedded portion of the electrode lead 3 can be changed as shown in FIGS. 19C and 19D. As shown in FIGS. 19C and 19D, when the delivery device 200 is rotated, the electrode lead 3 passes through the side opening 12a of the first needle 12. As shown in FIG. 19D, when the first needle 12 is rotated, the electrode lead 3 can bend. Thereby, the side opening 12a reduces the tension of the electrode lead 3 and reduces the pulling of the electrode lead 3 when the first needle 12 is rotated, making it easier for the electrode lead 3 to remain in the embedded position.

[0165] When a guide is used as described above, the guide may be removed before rotating the delivery device 200.

[0166] As shown in FIG. 19D, the electrode lead wire 3 may be provided with one or more misalignment prevention mechanisms 60 (for example, elastic barbs or hooks, etc.). The misalignment prevention mechanism 60 expands when the second needle 13 is retracted and functions to hold the end of the electrode lead wire 3 at a predetermined position with respect to the nerve. Therefore, the end of the electrode lead wire 3 having the electrode 4 is relatively fixed within the tissue, and the remaining portion of the electrode lead wire 3 (and the housing portion 2) can be moved (for example, rotated) as described above without changing the position of the electrode 4 with respect to the nerve.

[0167] From the positions shown in FIGS. 19C and 19D, the housing portion 2 can be deployed into the patient's tissue from the first needle 12 at an angle (inclination) different from that of the end of the electrode lead wire 3. Therefore, the orientation of the housing portion 2 may be different from the orientation of the electrode lead wire 3 when implanted. This is advantageous for aligning the housing portion 2 (and the wireless power supply received within the housing portion 2) with an external device (wearable device), and can help the medical implant better conform to the anatomical structure of the implantation site.

[0168] In an example to be further described below with reference to FIG. 20, the housing portion 2 can be implanted (mainly) within subcutaneous tissue (especially fascia). The housing portion 2 is implanted so as to be substantially parallel to the surface of the skin, while the electrode lead wire 3 extends to a deeper position within the tissue, close to the target nerve. The housing portion 2 has an elongated shape (for example, cylindrical), and the longitudinal axis of the housing portion 2 is parallel to the surface of the skin when implanted.

[0169] To deploy the housing portion 2 from the first needle 12, the activation tab 16 may be fully pushed toward the handle 11, whereby the second rack portion 30B pushes the housing portion 2 out of the first needle 12. Alternatively, another deployment member (retention member) may be used.

[0170] As shown in FIG. 19E, before deploying the housing portion 2, if necessary, the second needle 13 may be at least partially redeployed (pushed outward), thereby forming an opening in the tissue for receiving the housing portion 2 or facilitating the placement of the housing portion 2 within the patient's tissue. This can be achieved by pulling the actuation tab 16 away from the handle 11. Regardless of whether the second needle 13 is repositioned, the delivery device 200 (particularly, the first needle 12) may be further pushed into the patient's tissue before deploying the housing portion 2, thereby achieving, for example, a desired implantation depth or position of the housing portion 2 within the subcutaneous tissue (e.g., fascia). The delivery device 200 is preferably rotated so that the first needle 12 is as parallel as possible to the surface of the skin, whereby the housing portion 2 can be implanted as parallel as possible to the surface of the skin.

[0171] To deploy and implant the housing portion 2, the actuation tab 16 is pushed toward the handle 11. This fully retracts the second needle 13 and the second rack portion 30B pushes the housing portion 2 out of the first needle 12. Thereafter, the delivery device 200 can be removed from the patient.

[0172] FIG. 20 shows an example of the implantation position of a medical implant in a patient's tissue targeting the nerve 9. The implantation position shown in FIG. 20 can be achieved using the delivery device and procedure detailed with reference to FIGS. 18A - 19E. As shown, the electrode lead 3 is implanted in the vicinity of the nerve 9 and the housing portion 2 is implanted in the subcutaneous tissue 7. The housing portion 2 is implanted substantially parallel to the skin 5 and the electrode lead 3 is bent to extend at an angle different from that of the housing portion 2. In this way, the electrode lead 3 is implanted in the vicinity of the nerve 9 and the housing portion 2 is implanted in the subcutaneous tissue in an advantageous orientation for wireless power transmission, wireless communication, and / or comfortable wearing of the medical implant by the patient.

[0173] FIG. 21 shows a medical implant 1 of another example. In some examples, the medical implant 1 may be a nerve stimulation implant or a diagnostic implant. As described above, the medical implant 1 includes a housing portion 2 and an elongated electrode lead wire 3. The housing portion 2 houses electronic components (e.g., a printed circuit board, a receiver and a transmitter for wireless communication, and / or sensor electronics) of the medical implant 1 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.

[0174] As shown in the figure, in this example, the medical implant 1 further includes an external antenna 300 extending from the housing portion 2. The external antenna 300 extends from the side surface of the housing portion 2. In this example, the external antenna 300 extends from the vicinity of the end portion where the electrode lead wire 3 extends on the side surface of the housing portion 2. The external antenna 300 may be a wireless communication antenna and / or an antenna for wireless power reception. The external antenna 300 has flexibility (flexibility). The external antenna 300 includes a flexible body and a coiled antenna member provided within the flexible body. As shown in the figure, the external antenna 300 is attached to the housing portion 2 by a shaft 301 that extends perpendicular to the housing portion 2.

[0175] 21 is implanted in a patient, the external antenna 300 may be at a different angle and orientation than the housing portion 2 and the electrode lead 3. This may advantageously improve wireless communication and / or wireless power transmission using the external antenna 300 by facilitating better orientation of the external antenna 300 relative to an external device (e.g., a wearable device) that wirelessly communicates with or provides wireless power transmission to the medical implant 1. For example, the external antenna 300 may be positioned approximately parallel to the patient's skin surface, thereby making it approximately parallel to a wireless communication device and / or a wireless power supply device (e.g., a wearable device) provided on the skin surface.

[0176] 22A-22D show a delivery device 302 for implanting the medical implant 1 shown in FIG. 21. In this example, the delivery device 302 has a handle 11 and a delivery sheath. In this example, the delivery sheath has 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 in the delivery device 302 are configured in substantially the same manner as those described above with reference to FIGS. 18A-18E. In particular, the delivery device 302 includes a rack and pinion mechanism. In other examples, the delivery device 302 may be substantially the same as the delivery device 10 described above with reference to FIGS. 4-10 or 12 and 13.

[0177] As shown in Figures 22A and 22B, the first needle 12 of the delivery device 302 includes a slot 303 for receiving the shaft 301 of the medical implant 1 shown in Figure 21. The slot 303 extends from the distal end 16 of the first needle 12 toward the handle 11. As shown most clearly in Figure 22B, the shaft 301 extends from the housing portion 2 within the first needle 12 through the slot 303. An external antenna 300 extends from the end of the shaft 301.

[0178] As shown in the figure, the first needle 12 is provided with a guide channel 304 extending along the side surface of the first needle 12, and the slot 303 is present within the guide channel 304. The guide channel 304 is formed by two protrusions 305a, 305b extending from the first needle 12. Thereby, the guide channel 304 can accommodate the external antenna 300 and hold the external antenna 300 at a position extending along the first needle 12.

[0179] As shown in FIG. 22C, the guide channel 304 is provided with one or more deflectors 306. Therefore, when the housing portion 2 is pushed along the first needle 12 and deployed, the external antenna 300, which was initially parallel to the first needle 12, is deflected by the deflector 306. The external antenna 300 is deflected outward of the guide channel 304 substantially perpendicular to the longitudinal direction of the first needle 12, as shown in FIGS. 22A and 22B.

[0180] The end of the external antenna 300 may be a sharp tip for cutting a path through the tissue when pushed outward. In this way, when the housing portion 2 is deployed in a first direction parallel to the first needle 12, the external antenna 300 is deployed laterally (in the lateral direction of the housing portion 2) from the housing portion 2.

[0181] In the example of FIG. 22D, the delivery device 302 may include a flexible sheath (flexible sheath) 307 disposed within the guide channel 304. The flexible sheath 307 partially surrounds the external antenna 300 and is movable relative to the first needle 12 (e.g., slidable within the guide channel 304). Thereby, the sheath 307 can hold the external antenna 300 to be deployed laterally as shown in FIG. 22D. In some examples, the flexible sheath 307 can be deflected by the deflector 306 as described above. In other examples, the flexible sheath 307 may include a shape memory material biased toward the deployed position shown in FIG. 22D. Thereby, as the sheath 307 is pushed forward from the end of the guide channel 304, it moves laterally and guides (transports) the external antenna 300 to the lateral deployment position as shown.

[0182] Throughout the description and claims of this specification, terms such as "comprising," "having," "including," are intended to be "comprising (having, including) non - restrictively" 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 form. 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.

[0183] 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 being applicable to other aspects, embodiments, or examples described herein, unless they are 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 present invention is not limited to the details of the above-described embodiments. The present invention extends to any novel and / or novel combination of features disclosed in this specification (including the appended claims, abstract, and drawings), or any novel and / or novel combination of steps of any methods or processes.

Claims

1. A delivery device for percutaneously delivering medical implants to a patient's tissue, The delivery sheath comprises a lumen configured to hold the aforementioned medical implant, The delivery sheath is percutaneously positioned to implant the medical implant into the patient's tissue. The side wall of the delivery sheath has a lateral opening for the discharge of at least a portion of the medical implant during use. Delivery device.

2. The aforementioned medical implant comprises a housing portion and an elongated electrode lead wire extending from the housing portion. The delivery sheath comprises a first portion configured to hold the housing portion and a second portion configured to hold the electrode lead wires. The first portion of the delivery sheath is provided with the side opening, The delivery device according to claim 1.

3. The side opening is sized to allow the housing portion to be discharged during embedding. The delivery device according to claim 2.

4. The system further includes a pusher that is operable to push the housing through the side opening during use. The delivery device according to claim 3.

5. The delivery sheath further comprises a guide portion positioned within the delivery sheath, The guide portion is configured to guide the housing portion of the medical implant as it is discharged from the side opening during use. The delivery device according to claim 3.

6. The guide portion is shaped to rotate the housing portion when the housing portion is being discharged from the side opening. The delivery device according to claim 5.

7. The side opening is sized to hold the housing portion in the first portion of the delivery sheath, and to allow a portion of the electrode lead wire to pass through the side opening. The delivery device according to claim 2.

8. The first portion of the delivery sheath is shaped such that, during use, a portion of the electrode lead wire can overlap the housing portion within the first portion of the delivery sheath. The delivery device according to claim 7.

9. In the electrode lead wire, the portion of the first portion of the delivery sheath that overlaps with the housing portion is aligned with the side opening in the first portion of the delivery sheath. The delivery device according to claim 8.

10. The delivery sheath further comprises a pusher that is operable to push the housing out from the first portion of the delivery sheath. A delivery device according to any one of claims 7 to 9.

11. The second portion of the delivery sheath is retractable into the first portion of the delivery sheath for embedding the electrode lead wires. A delivery device according to any one of claims 2 to 9.

12. The second portion of the delivery sheath comprises a slot extending along the side surface of the second portion of the delivery sheath. A delivery device according to any one of claims 2 to 9.

13. The delivery sheath includes a needle and / or cannula. A delivery device according to any one of claims 1 to 9.

14. For example, medical implants such as nerve stimulation implants or diagnostic implants, Housing section, An electrode lead wire extending from the housing portion and having one or more electrodes, An antenna extending from the aforementioned housing section, A medical implant equipped with [a specific feature / feature].

15. The antenna is flexible, A medical implant according to claim 14.

16. The tip of the aforementioned antenna is pointed. A medical implant according to claim 14 or claim 15.

17. The aforementioned antenna is an antenna for wireless power reception and / or wireless communication. A medical implant according to claim 14 or claim 15.

18. A delivery device for percutaneously delivering medical implants to a patient's tissue, The aforementioned medical implant comprises an elongated housing portion and a flexible antenna extending from the side of the housing portion. The delivery device comprises a delivery sheath for percutaneously implanting the medical implant into the patient's tissue. The aforementioned delivery sheath is A lumen configured to hold the housing portion of the medical implant, A guide channel formed along the side surface of the delivery sheath to hold the flexible antenna, A slot extending from the guide channel to the lumen, Delivery device.

19. The system further comprises a pusher that is operable to push the housing portion through the lumen of the delivery sheath. The delivery device according to claim 18.

20. The guide channel includes a deflector configured to deflect the flexible antenna away from the delivery sheath when the medical implant is pushed through the lumen of the delivery sheath. The delivery device according to claim 19.

21. The system further comprises a flexible sheath slidably positioned within the guide channel and operable to extend laterally while holding the flexible antenna. A delivery device according to any one of claims 18 to 20.

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