Delivery device and method for percutaneously implanting a medical implant

Abstract

The present invention provides a delivery device (10) for percutaneously implanting a medical implant (1) into a patient's tissue. The delivery device comprises a delivery sheath (12, 13, 53, 61, 62, 65, 66) configured to at least partially surround the medical implant and hold the medical implant for percutaneous delivery into the patient's tissue. The delivery device also comprises a power supply system (37) configured to supply power to the medical implant within the delivery sheath.

Description

Technical Field

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

Background Art

[0002] It is known to provide an implantable nerve stimulation device comprising a housing and an electrode. In this case, a power antenna, a microcontroller, and a communication antenna are arranged 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 place an implantable nerve stimulation device in a patient's body (particularly in the vicinity of a nerve). In this case, an incision is made in the patient, and the nerve stimulation device is placed by passing the delivery system through the incision.

Summary of the Invention

[0003] According to a first aspect of the present invention, there is provided a delivery device for percutaneously implanting a medical implant into a patient's tissue, the delivery device comprising a delivery sheath configured to at least partially surround the medical implant and hold (carry) the medical implant for percutaneous delivery into the patient's tissue, and a power supply system configured to supply power to the medical implant within the delivery sheath.

[0004] An advantage of the power supply system is that power can be supplied to the medical implant during implantation to inspect its position before the medical implant is fully implanted (deployed).

[0005] In some examples, the medical implant may include a power supply terminal. In such an example, the power supply system may include an electrical contact disposed within the delivery sheath to form an electrical connection with the power supply terminal of the medical implant.

[0006] In some examples, the medical implant may include a wireless power receiver. In such an example, the power supply system may include a wireless power transmitter configured to perform wireless power transmission to the wireless power receiver of the medical implant. The wireless power transmitter may be disposed within the delivery sheath.

[0007] In some examples, the delivery device may further include a guide configured to constrain the position and orientation of the delivery sheath relative to the patient during use, and the power supply system may be provided within the guide. The guide may be removable from the delivery sheath. The guide may be leaned against the patient or attached to the patient. The guide may include a guide channel through which the delivery sheath passes, and the guide channel constrains 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 the portion of the guide that engages the patient) may be adjustable to be able to adjust the position and orientation of the delivery sheath.

[0008] In some examples, the delivery device may further include a power source (e.g., a battery). In other examples, the delivery device may further include a connector for an external power source (e.g., a main power source or an external battery). In other examples, the delivery device may further include a wireless power receiver for wireless power coupling with an external wireless power transmitter. The external wireless power transmitter may be a device (e.g., a wearable device) used with the medical implant after implantation.

[0009] In some examples, the delivery device comprises a handle, and the delivery sheath extends from the handle. In some examples, at least a portion of the delivery sheath is retractable (storable) relative to the handle to partially expose the medical implant during percutaneous delivery into the patient's tissue. In some examples, at least a portion of the delivery sheath may be retractable (storable) to release (deliver) the medical implant within the patient's tissue. In some examples, the delivery sheath may include a needle or a cannula.

[0010] In some examples, the medical implant may comprise a housing portion and an elongated electrode lead extending from the housing portion. The delivery sheath may be configured to hold (carry) the housing portion for percutaneous delivery into the patient's tissue. In some examples, the delivery sheath may also be configured to hold (carry) the electrode lead for percutaneous delivery into the patient's tissue. In some examples, the delivery sheath may be configured to hold (carry) an elongated electrode lead for percutaneous delivery into the patient's tissue and may include a retractable portion (storage portion).

[0011] In some examples, the medical implant is a nerve stimulation implant. In such examples, the delivery device may further comprise a sensor operable to detect a patient's response when the power supply system supplies power to the nerve stimulation implant during percutaneous delivery. In particular, the medical implant may comprise one or more electrodes operable to stimulate a patient's nerve, and the sensor may be one that detects the patient's response to the stimulation. In some examples, the sensor may be configured to detect a response to the patient's movement (action). In some examples, the sensor is configured to detect nerve signals.

[0012] In some examples, the delivery device may further include a graphical user interface (GUI) operable to display the information received from the sensor. The graphical user interface (GUI) may also be configured to display the operating characteristics of the medical (nerve stimulation) implant, such as the frequency or amplitude of the operation. The graphical user interface (GUI) may also be provided with a user input section for controlling the delivery device (e.g., the power supply system).

[0013] According to a second aspect of the present invention, there is provided a medical implant for embedding in a patient's tissue, comprising a wireless power receiver and a power supply terminal for forming an electrical connection between the wireless power receiver and an electrical connector of a delivery device during implantation of the medical implant.

[0014] Advantageously, the power supply terminal enables power to be supplied to the medical implant within the delivery device during implantation, so that the implantation site of the medical implant can be inspected before the medical implant is fully implanted (deployed). Such direct power supply via the power supply terminal can be more reliable and efficient than power supply using the wireless power receiver while the medical implant is held within the delivery device.

[0015] In some examples, the medical implant may further include a housing portion, and the power supply terminal may be disposed on the housing portion. The power supply terminal may be disposed at an end of the housing portion. The power supply terminal may be disposed on a side surface of the housing portion. For example, the power supply terminal may be a ring electrode extending circumferentially around the housing portion. The housing portion may further house electronic components of the medical implant, including the wireless power receiver. In some examples, the power supply terminal on the housing portion may also function as an electrode for stimulation and / or detection when the medical implant is implanted. For example, the power supply terminal may be configured as a bioimpedance sensor.

[0016] In some examples, the medical implant may further include an elongated electrode lead extending from the housing portion, and the elongated electrode lead may include an electrode. The electrode may be a stimulating electrode and / or a detecting electrode.

[0017] According to a third aspect of the present invention, there is provided a medical implant for embedding in a patient's tissue, comprising a first wireless power receiving unit for wireless power coupling with an external wireless power transmitting unit when implanted in the patient's body, and a second wireless power receiving unit for wireless power coupling with a wireless power transmitting unit of a delivery device during implantation of the medical implant.

[0018] In some examples, there is provided a medical implant for embedding in a patient's tissue, comprising a wireless power receiving unit that is selectively adjustable to receive wireless power transmission from an external wireless power transmitting unit when implanted in the patient's body and to receive wireless power transmission from a wireless power transmitting unit of a delivery device during implantation of the medical implant.

[0019] In some examples, the medical implant may be a nerve stimulation implant configured to stimulate a patient's nerve or target tissue. 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 (e.g., oxygen, carbon dioxide, carbon monoxide), etc.).

[0020] According to a fourth aspect of the present invention, 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 having a power supply system and a delivery sheath for holding the medical implant, percutaneously placing the delivery sheath into the patient's tissue, and inspecting the position of the medical implant by supplying power to the medical implant within the delivery sheath by the power supply system of the delivery device.

[0021] Advantageously, the medical implant can be powered during implantation to inspect its position before being fully implanted (deployed).

[0022] In some examples, the method may further comprise the step of exposing the electrodes of the medical implant while inspecting the position of the medical implant.

[0023] In some examples, the method may further comprise the step of repositioning the delivery sheath based on feedback obtained from the inspection of the position of the medical implant. Here, the feedback may be provided by the patient (e.g., pain, tingling sensation, etc.), visual feedback from the operator (e.g., movement, other changes, etc.), or provided by a sensor.

[0024] In some examples, the method may comprise the step of using a guide portion that restricts (limits) the position and orientation of delivery to the patient while percutaneously placing the delivery sheath into the patient's tissue.

[0025] In some examples, the medical implant may be composed of a nerve stimulation implant. In such an example, the method may further comprise the step of detecting a patient's reaction while examining the position of the nerve stimulation implant. In some examples, the step of detecting a patient's reaction may include detecting a reaction to the patient's movement (action). In some examples, the step of detecting a patient's reaction may include detecting the patient's nerve signal.

[0026] In some examples, the method may further comprise the step of displaying information received from a sensor on a graphical user interface. In some examples, the method may further comprise the step of displaying information regarding the operation of the medical implant on a graphical user interface. For example, the method may comprise the step of displaying the operating characteristics of the medical implant.

[0027] In some examples, the medical implant may comprise a housing portion and an elongated electrode lead wire having an electrode. The method may comprise the step of implanting the housing portion at a first depth in the patient's tissue and the step of implanting the electrode lead wire at a second depth in the patient's tissue. The second depth may be greater than the first depth. In some examples, the method may comprise the step of implanting the electrode lead wire at an angle different from the housing portion. In some examples, the housing portion comprises a wireless power receiver and is implanted such that the wireless power receiver faces the patient's skin surface (e.g., such that the housing portion is substantially parallel to the skin surface). In some examples, the electrode lead wire may be implanted in a non-linear arrangement (e.g., an arrangement in which a first portion is substantially parallel to the housing portion and a second portion extends at an angle with respect to the housing portion toward the patient's nerve).

[0028] According to a fifth aspect of the present invention, there is provided a delivery device for percutaneously implanting a medical implant into a patient's tissue, the delivery device comprising: a delivery sheath configured to at least partially surround the medical implant and hold (carry) the medical implant for percutaneous delivery to the patient's tissue; and an impedance sensor having a first electrode and a second electrode disposed to contact the patient at spaced-apart positions, the impedance sensor being operable to detect an electrical impedance between the first electrode and the second electrode to detect a change in the tissue at the delivery sheath during percutaneous delivery of the medical implant.

[0029] Advantageously, the detected electrical impedance can notify the operator when the delivery sheath approaches or passes through different tissue types. This helps to place the delivery sheath and the medical implant in the appropriate location during implantation.

[0030] In some examples, the first electrode and / or the second electrode may be disposed on the delivery sheath (e.g., at or near the tip of the delivery sheath). In other examples, the first electrode and / or the second electrode may be provided on the medical implant. The first electrode and / or the second electrode may be a detection electrode or a stimulation electrode of the medical implant. In some examples, the medical implant comprises a housing portion and an electrode lead extending from the housing portion, and the first electrode and / or the second electrode may be formed on the housing portion or the electrode lead. In some examples, the second electrode may be disposed relative to the patient's skin in the vicinity (periphery) of the percutaneous delivery site, and may be, for example, adhered to the skin or fixed (bandage-fixed).

[0031] In some examples, the delivery device may further comprise an impedance analyzer configured to analyze the detected electrical impedance. In some examples, the impedance analyzer is configured to compare the detected electrical impedance to a threshold value. In some examples, the impedance analyzer may be configured to compare the detected electrical impedance to a database or other comparable data to determine, for example, tissue type or anatomical features. In some examples, the database or comparable data may be provided at a distributed location and the impedance analyzer may communicate via a wireless communication channel.

[0032] In some examples, the delivery device may further comprise a graphical user interface (GUI) configured to display information received from the impedance analyzer. The graphical user interface (GUI) may also display operating characteristics of the medical implant (e.g., frequency or amplitude of operation). The graphical user interface (GUI) may also provide a user input for controlling the delivery device (e.g., an impedance sensor system).

[0033] In some examples, the delivery device may further comprise a power supply system configured to supply power to the medical implant within the delivery sheath. The power supply system may comprise any of the features described above in connection with the first to fourth aspects of the present invention.

[0034] According to a sixth aspect of the present invention, there is provided a method of percutaneously implanting a medical implant into a patient's tissue, the method comprising: percutaneously positioning a delivery sheath of a delivery device holding the medical implant; detecting an electrical impedance between a first electrode and a second electrode in contact with the patient at spaced apart positions; and analyzing the detected electrical impedance to detect tissue changes at the delivery sheath during percutaneous delivery of the medical implant.

[0035] Advantageously, the detected electrical impedance can notify the operator when the delivery sheath approaches or passes through different tissue types. This helps to properly position the delivery sheath and the medical implant during implantation.

[0036] In some examples, the method may further comprise comparing the detected electrical impedance to a threshold value. In some examples, the method may comprise comparing the detected electrical impedance to a database or other comparable data, for example, to determine a tissue type or anatomical feature. In some examples, the database or comparable data is provided at a distributed location and the impedance analyzer can communicate via a wireless communication channel.

[0037] In some examples, the method may further comprise displaying information regarding the detected electrical impedance on a graphical user interface.

[0038] In some examples, the method may further comprise powering the medical implant within the delivery sheath to inspect the position of the medical implant before fully releasing the medical implant from the delivery sheath. The method may further comprise any of the features described above in relation to the first to fourth aspects of the present invention.

[0039] According to a seventh aspect of the present invention, there is provided a method for transcutaneously delivering a nerve stimulation implant to a patient's tissue, the method comprising the steps of: transcutaneously placing a delivery sheath holding the nerve stimulation implant; detecting a change in electrical impedance between a first electrode and a second electrode in contact with the patient at spaced-apart positions, the change in electrical impedance indicating a change in the patient's tissue in the delivery sheath; and powering the nerve stimulation implant within the delivery sheath to examine the relative position of the nerve stimulation implant with respect to the patient's nerve.

[0040] In some examples, the method may further comprise the steps of: placing the delivery sheath in the vicinity (periphery) of the nerve based on the detected electrical impedance; and after that step, powering the nerve stimulation implant within the delivery sheath to examine the relative position of the nerve stimulation implant with respect to the nerve.

[0041] Advantageously, the detected change in electrical impedance can inform the operator that the delivery sheath is approaching a nerve or other target anatomical site, and by powering the nerve stimulation implant within the delivery device, the operator can examine the implantation site before fully implanting (deploying) the nerve stimulation implant. Thus, the implantation position can be improved, and removal or repositioning that could cause difficulties or damage to the nerve stimulation implant can be avoided.

[0042] In some examples, the method may further comprise the step of partially retracting (storing) the delivery sheath so as to expose the electrodes of the nerve stimulation implant prior to powering the nerve stimulation implant within the delivery sheath.

[0043] According to a further aspect of the present invention, there is provided a delivery device for percutaneously implanting a medical implant into a patient's tissue, the delivery device comprising a delivery sheath configured to be percutaneously disposed, the delivery sheath having a lumen configured to hold (carry) a medical implant for percutaneous implantation.

[0044] In some examples, the delivery sheath comprises a cannula or a needle for percutaneously implanting a medical implant. The cannula or the needle is percutaneously deployable, and the medical implant can be discharged from the cannula or the needle, for example, by a pusher. The needle may comprise a sharp tip (e.g., a beveled tip). The needle or the cannula may be configured to pierce the patient's skin or may be inserted through an incision in the patient's skin.

[0045] In some examples, the delivery sheath may comprise a first portion for holding a first portion of the medical implant (e.g., a housing portion) and a second portion protruding from the first portion for holding a second portion of the medical implant (e.g., an electrode lead wire). The first portion and the second portion may be fixed to each other and may have different diameters from each other (e.g., the diameter of the second portion may be smaller than the diameter of the first portion). The second portion may have a slot extending along its entire length (from the first portion to the tip of the second portion). The first portion may have a slot or an opening on its side surface that is aligned with the slot of the second portion. In this way, the medical implant can be implanted (deployed) by pushing the medical implant out of the first and second portions of the delivery sheath by a pusher. For example, the housing portion may be pushed out from the first portion through the slot or the opening, and then the delivery device may be pulled back (retracted) to completely implant the medical implant.

[0046] In some examples, a medical implant may include a housing portion (e.g., for housing an electronic device of the medical implant such as a wireless power receiver), and an elongated electrode lead wire extending from the housing portion. In some examples, the delivery sheath may include a first needle or a first cannula configured to hold the medical implant such that the electrode lead wire is directed away from the tip of the needle. A second needle may hold the electrode lead wire within the first needle or the first cannula, and the second needle may be extendable beyond the tip of the first needle or the first cannula for embedding the electrode lead wire.

[0047] In some examples, the delivery device may further include a power supply system for supplying power to a medical implant within the delivery device.

[0048] In some examples, the delivery device may further include an impedance sensor system for detecting changes in tissue in the delivery sheath during percutaneous delivery of the medical implant.

[0049] In some examples, the delivery device may further include other features of the delivery device described above with reference to Aspects 1-7 of the present invention.

[0050] According to a further aspect of the present invention, there is also provided a medical implant comprising a wireless power receiver configured to wirelessly connect (wirelessly couple) to an external device to receive wireless power, and a wireless power transmitter configured to wirelessly connect (wirelessly couple) to another medical implant to transmit wireless power to the another medical implant.

[0051] The medical implant may include a first portion that holds a wireless power receiver and a second portion that holds a wireless power transmitter. The second portion may be implanted at a depth greater than the depth of the first portion (with respect to the skin). Thereby, the medical implant can function as a power relay for improving wireless power transmission to another medical implant. In some examples, the another medical implant may be a deep tissue medical implant (e.g., a nerve stimulation implant, a diagnostic implant, a pacemaker implant, etc.).

Brief Description of the Drawings

[0052] Embodiments of the present invention are further described with reference to the following attached drawings.

[0053]

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DETAILED DESCRIPTION OF THE INVENTION

[0054] FIG. 1 schematically shows a medical implant 1. In some examples, the medical implant 1 may be a nerve stimulation implant or a diagnostic implant. The medical implant 1 includes a housing portion 2 and an elongated electrode lead wire 3. The housing portion 2 houses electronic components (electronic devices) of the medical implant 1 (for example, a printed circuit board, a wireless communication receiver and a wireless communication transmitter, a wireless power receiver, and / or sensor electronic devices) 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 surrounding the electronic components within the housing portion 2.

[0055] In some examples, the electrode lead wire 3 extends from the housing portion 2 and has flexibility (flexibility). The electrode lead wire 3 includes at least one electrode 4. In some examples, the electrode lead wire 3 includes a plurality of electrodes 4 arranged at intervals in the length direction of the electrode lead wire 3. The electrode 4 is connected to the electronic components within the housing portion 2.

[0056] 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, since the dimensions of the housing portion 2 correspond to the size of the electronic component housed in the housing portion 2 and the length of the electrode lead wire 3 corresponds to the anatomical structure around the target nerve, it will be understood that a shorter or longer electrode lead wire 3 may be appropriate depending on the depth of the nerve in the muscle tissue.

[0057] 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 (in particular, the medial and / or distal branches of the hypoglossal nerve). In one example, the medical implant 1 is implantable within a patient's body and operable to detect and / or stimulate the hypoglossal nerve branches within the genioglossus muscle. In some examples, the medical implant 1 is implantable to detect and / or stimulate the tibial nerve. Treatments for sleep apnea may be provided by stimulating the hypoglossal nerve (genioglossus nerve branches) and / or the phrenic nerve. 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 (in particular, 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).

[0058] Figure 2 shows the medical implant 1 implanted in a patient. The medical implant 1 is disposed beneath the surface of the skin 5 (in particular, 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 and also improve wireless power transmission between the external device and the medical implant.

[0059] As shown in the figure, the electrode lead wire 3 extends from the housing portion 2 through the lower tissue (particularly, the muscle 8) to the position of the adjacent portion (periphery) of the target nerve 9. The electrode lead wire 3 is arranged such that the electrode 4 (see FIG. 1) contacts or is close to the nerve 9. Thereby, it becomes possible to detect and / or stimulate the nerve 9 using the electrode 4. In some examples, the electrode lead wire 3 may be embedded so as to be substantially parallel to the nerve 9 at least in the region of the electrode 4.

[0060] The medical implant 1 may include one or more displacement prevention members (migration prevention members, movement prevention members). The displacement prevention member may be provided on the housing portion 2 and / or the electrode lead wire 3, and functions to hold the medical implant 1 at a predetermined position within the patient's tissue.

[0061] In some examples, the medical implant 1 is battery - less and does not have an integrated power source. The external device 32 can wirelessly supply power to the medical implant 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 arranged on the skin of the adjacent portion (peripheral portion) of the medical implant 1. The external device 32 may be attached to the skin of the adjacent portion (peripheral portion) of the medical implant 1. The external device 32 may be a wearable device.

[0062] 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 (for example, the hypoglossal nerve (distal branch and / or medial branch) (for example, the genioglossus nerve branch), or the greater occipital nerve, etc.).

[0063] During operation, an electrical signal such as a current is supplied to the electrode 4 of the implant for nerve stimulation to stimulate the nerve or target tissue. In some examples, the electrical signal may be a voltage-controlled stimulation. Such stimulation can bring about relief of various symptoms, such as sleep disorders (hypoglossal nerve and / or cervical nerve trap), chronic pain (e.g., occipital neuralgia, intractable migraine, etc.), and / or other therapeutic effects.

[0064] 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 examples, 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).

[0065] In other examples, the medical implant 1 may be a diagnostic implant operable to detect one or more vital signs of a patient (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.)).

[0066] Figures 3A to 3E show alternative examples of the medical implant 1. In each alternative example, the medical implant 1 has a housing portion 2 and one or more electrodes 4. In the examples of Figures 3A to 3D, the medical implant 1 includes an electrode lead wire 3 and an electrode 4 formed on the electrode lead wire 3. In the example of Figure 3E, the medical implant 1 does not include an electrode lead wire 3, and the electrode 4 is formed on the housing portion 2. The example of Figure 3E may be a nerve stimulation implant or a diagnostic implant that can be implanted in the vicinity (peripheral part) of a nerve in the same manner as described above.

[0067] In the examples of FIGS. 3A to 3E, the housing unit 2 includes a casing 2a. The casing 2a may be cylindrical and can accommodate electronic components therein. The casing 2a is preferably made of ceramic (e.g., zirconia). The housing unit 2 includes wireless power receivers 35, 35b for receiving wireless power supply from an external device 32 (see FIG. 2) after being implanted in a patient. In some examples, the wireless power receivers 35, 35b may also be used for wireless data communication with the external device 32 (see FIG. 2). In the examples of FIGS. 3A to 3D, the medical implant 1 also includes an electrode lead wire 3 extending from the housing unit 2, and the electrode 4 may be provided on the electrode lead wire 3.

[0068] As shown in FIG. 3A, the housing unit 2 includes a first power terminal 33a and a second power terminal 33b formed in the casing 2a of the housing unit 2. In particular, the first power terminal 33a and the second power terminal 33b are conductive regions of the casing 2a and are separated from each other by an insulating portion 34. The first power terminal 33a and the second power terminal 33b may be point contacts. Alternatively, the first power terminal 33a and the second power terminal 33b are conductive regions of the casing 2a and may extend over a partial length range of the casing 2a. As will be further described below, the first power terminal 33a and the second power terminal 33b may be connected to a power supply system in the delivery device to supply power to the medical implant 1 in the delivery device during implantation. The wireless power receiver 35 may be disposed within the housing unit 2 and may be spaced apart from the first power terminal 33a and the second power terminal 33b.

[0069] In the example of FIG. 3B, the housing part 2 includes a first power supply terminal 36a and a second power supply terminal 36b formed at the end of the housing part 2 (particularly, the end of the casing 2a on the side opposite to the electrode lead wire 3). As will be further described below, the first power supply terminal 36a and the second power supply terminal 36b may be connected to the power supply system in the delivery device to supply power to the medical implant 1 in the delivery device during implantation. The wireless power receiver 35 may be disposed within the housing part 2 and may be spaced apart from the first power supply terminal 36a and the second power supply terminal 36b.

[0070] In the example of FIG. 3C, the housing part 2 includes a first wireless power receiver 35a and a second wireless power receiver 35b. As will be further described below, the first wireless power receiver 35a is configured (arranged) to receive wireless power while the medical implant 1 is within the delivery device during implantation. The second wireless power receiver 35b is configured (arranged) to receive wireless power from an external device 32 (see FIG. 2) when the medical implant 1 is implanted in the patient's body. In this example, as shown, the housing part 2 optionally includes a first power supply terminal 36a and a second power supply terminal 36b similar to those described with reference to FIG. 3B. In another example, the housing part 2 may include a first power supply terminal 33a and a second power supply terminal 33b similar to those described with reference to FIG. 3A.

[0071] In another example, the medical implant 1 may include a single wireless power receiving unit 35. As will be described later, the single wireless power receiving unit 35 can receive wireless power from the wireless power transmitter of the delivery device during implantation, and can also receive wireless power from an external device 32 (see FIG. 2) after the medical implant 1 is implanted into the patient's body. In this example, the wireless power receiving unit 35 may be configured to be adjustable, for example, to operate at a plurality of different frequencies to receive power during and after implantation. Advantageously, this enables the wireless power receiving unit 35 (and thus the medical implant 1) to be inspected during implantation.

[0072] In the example of FIG. 3D, the housing portion 2 includes a first power supply terminal 36a and a second power supply terminal 36b formed as ring electrodes on the casing 2a. As will be further described below, the first power supply terminal 36a and the second power supply terminal 36b may be connected to a power supply system in the delivery device to supply power to the medical implant 1 in the delivery device during implantation. The wireless power receiving unit 35 may be disposed within the housing portion 2 and may be spaced apart from the first power supply terminal 36a and the second power supply terminal 36b.

[0073] In some examples, the housing portion 2 may include two or more ring electrodes 36a, 36b (for example, four ring electrodes 36a to 36d as shown in FIG. 3D). One or more of the ring electrodes 36a to 36d may be used as sensors (for example, impedance sensors) after the medical implant 1 is implanted. In some examples, the same ring electrodes 36a to 36d may be used as power supply terminals for supplying power to the medical implant 1 in the delivery device and as sensor electrodes after implantation. In some examples, at least two of the ring electrodes 36a to 36d are made of different materials (in particular, different metals from each other), thereby enabling differential impedance detection.

[0074] In the example of FIG. 3E, the medical implant 1 includes a housing portion 2 and does not include the electrode lead wires 3 as in the examples of FIGS. 3A-3D. In this example, the casing 2a of the housing portion 2 is provided with a first power supply terminal 33a and a second power supply terminal 33b for connecting to the power supply system of the delivery device during implantation. The first power supply terminal 33a and the second power supply terminal 33b are separated from each other by an insulating portion (insulating region) 34. The casing 2a also includes electrodes 4 separated by other insulating portions 34. In some examples, as shown, the housing portion 2 holds a wireless power receiver 35. The wireless power receiver 35 may be disposed within the housing portion 2 and spaced apart from the first power supply terminal 33a, the second power supply terminal 33b, and the electrodes 4.

[0075] In the examples of FIGS. 3A-3E, the medical implant 1 includes a plurality of electrodes 4 and power supply terminals 33a, 33b, 36a, 36b for connecting to the power supply system of the delivery device during implantation. It will be understood that after implantation, the power supply terminals 33a, 33b, 36a, 36b may function as additional electrodes 4 (i.e., may be operated to detect nerve signals and / or to provide nerve stimulation).

[0076] Figures 4A and 4B 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 Figure 4A, the medical implant 1 may be connected to the other medical implant 73 by a wire 74. The medical implant 1 includes the wireless power receiver 35 as described above and transmits power to the other 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. This shortens the distance from an external wireless power transmitter, thereby improving the wireless power coupling. In the example of Figure 4B, the medical implant 1 includes a wireless power receiver 35 and a wireless power transmitter 75 and is arranged (configured) to relay power to a wireless power receiver 76 of the other medical implant 73. The wireless power transmitter 75 of the medical implant 1 may be connected to the housing portion 2 by a wire 77 as shown, or a wireless power transmitter 75hs may be provided within the housing portion 2 and the wire 77 may be omitted. The medical implant 1 can be implanted at a shallower position within the tissue than the other medical implant 73. This improves the wireless power coupling. In the examples of Figures 4A and 4B, the medical implant 1 may include power terminals 33a, 33b, 36a, 36b that allow the medical implant 1 to receive power within the delivery device during implantation, as will be described later, and / or a wireless power receiver 35a (and other features described with reference to Figures 3A - 3E).

[0077] Figures 5A - 5E show an example of a delivery device 10 for implanting the medical implant 1 shown in Figures 3A - 4B into a patient's tissue. In particular, the delivery device 10 is used to implant the medical implant 1 percutaneously at the position shown in Figure 2. The delivery device 10 of Figures 5A - 5E is illustrated with reference to an exemplary medical implant 1 (specifically, a nerve stimulation implant) having a housing portion 2 and an electrode lead wire 3, but it will be understood that the delivery device 10 may also be adapted for the implantation of other medical implants 1 described above with reference to Figures 3A - 3E.

[0078] In the example of Figures 5A - 5E, the delivery device 10 has a delivery sheath that includes a first portion and a second portion (specifically, a first needle 12 and a second needle 13). The first needle 12 and the second needle 13 are parallel to each other and both extend in the longitudinal direction. The second needle 13 extends further than the first needle 12. In particular, the first needle 12 has a tip 14 (e.g., a beveled tip), and the second needle 13 extends beyond the tip 14 of the first needle 12. The second needle 13 also has a tip 15 (specifically, a beveled tip). The gauge of the second needle 13 is larger than that of the first needle 12 (i.e., the diameter of the second needle 13 is smaller than the diameter of the first needle 12).

[0079] In use, the housing portion 2 of the medical implant 1 is received within the first needle 12 (specifically, the lumen of the first needle 12). In use, the electrode lead wire 3 is received within the second needle 13 (specifically, the lumen of the second needle 13). The electrode lead wire 3 extends along most of the second needle 13 towards the tip 15 as shown. As will be further described with reference to Figure 7, a portion of the electrode lead wire 3 adjacent to the housing portion 2 extends through the opening of the second needle 13. Thus, in use, the medical implant 1 is received within the first needle 12 and the second needle 13 of the delivery device 10.

[0080] As shown in the illustration, 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 accommodated within the first needle 12 along the housing portion 2.

[0081] Referring to FIG. 7, the second needle 13 has an opening 18 (i.e., a slot). Thereby, a part of the electrode lead wire 3 can extend from the second needle 13 and be connected to the housing portion 2. The opening 18 may extend to the tip 15 of the second needle 13. The opening 18 may extend along most of the second needle 13, or may extend along the entire length of the second needle 13.

[0082] Referring again to FIGS. 5A - 5E, during use, the first needle 12 penetrates the patient's tissue percutaneously and positions the housing portion 2 at a first depth, and the second needle 13 penetrates the patient's tissue percutaneously and positions the electrode lead wire 3 at a second depth. When the electrode lead wire 3 is properly positioned, the delivery device 10 releases (ejects) and deploys (deploy) the medical implant 1, leaving the medical implant 1 in the position shown in FIG. 2. In some examples, after the electrode lead wire 3 is implanted, the delivery device 10 may be rotated so that the housing portion 2 is angled and implanted with respect to the electrode lead wire 3. The delivery device 10 may be rotated while the first needle 12 is outside the patient's body (i.e., while it is not percutaneously positioned). The tip 14 of the first needle 12 and the tip 15 of the second needle 13 are each sharp tips configured to puncture the patient's skin and penetrate the tissue to percutaneously position the first needle 12 and the second needle 13 at an appropriate depth. The tip 14 of the first needle 12 and the tip 15 of the second needle 13 may be beveled tips, as is well known to those skilled in the art. In some examples, during use, the first needle 12 and the second needle 13 are used to puncture the patient's skin and underlying tissue, and in some examples, after an incision is first made, the first needle 12 and the second needle 13 are inserted into the patient's tissue through the incision.

[0083] In some examples, the gauge of the first needle 12 may be from 6 gauge to 15 gauge, for example, it may be 10 gauge. In some examples, the gauge of the second needle 13 may be from 15 gauge to 25 gauge, for example, it may be 20 gauge.

[0084] In some examples, the second needle 13 is retractable (storable) with respect to the first needle 12 to accommodate (deploy) the electrode lead wire 3. The opening 18 (see FIG. 7) along the second needle 13 enables the accommodation (deployment) of the electrode lead wire 3 when the second needle 13 is retracted.

[0085] In some examples, the housing part 2 is detachably attached to the first needle 12 (or another part of the delivery device 10) and is released before accommodation (deployment).

[0086] In some examples, by separating the delivery device 10 (implant delivery device) from the patient, using the friction between the electrode lead wire 3 and the patient's tissue to hold the medical implant in place, and simply separating the housing part 2 from the first needle 12, the housing part 2 can be accommodated (deployed) from the first needle 12. In other examples, the delivery device 10 may include a deployment member (e.g., a pusher) configured to push the housing part 2 out of the first needle 12 to accommodate (deploy) the housing part 2 at an appropriate anatomical site. In some examples, the delivery device 10 (implant delivery device) may include a holding member configured to hold the housing part 2 within the first needle 12 before deployment and may be operable to release (unlock) the housing part 2 before the delivery device 10 is removed.

[0087] As shown in FIGS. 5A to 5E, the delivery device 10 includes a power supply system 37. Specifically, the power supply system 37 is configured to supply power to the medical implant 1 within the delivery device 10 when the housing portion 2 is housed in the first needle 12 and the electrode lead wire 3 is housed in the second needle 13. In the above configuration, since the wireless power receivers 35, 35B (see FIGS. 3A to 3E) do not always reliably receive wireless power from the external device 32 (see FIG. 2), a power supply system 37 is provided within the delivery device 10 so that power is supplied to the medical implant 1 within the delivery device 10. It may be advantageous to supply power to the medical implant 1 within the delivery device 10 in order to inspect the position of the electrode 4 during implantation before completely implanting the medical implant 1 from the delivery device 10. In some examples, to inspect the position of the electrode 4, the second needle 13 is partially retracted to expose the electrode 4, and the power supply system 37 is operated to supply power to the medical implant 1.

[0088] In the example of FIG. 5A, the delivery device 10 holds the medical implant 1 shown in FIG. 3A, and the first power terminal 33a and the second power terminal 33b are formed on the housing portion 2. It will be understood that the delivery device 10 of FIG. 13A can also be used for the medical implant shown in FIG. 3D. In the example of FIG. 5A, the power supply system 37 includes a first connector 39a and a second connector 39b disposed within the first needle 12. The first connector 39a is arranged to connect to the first power terminal 33a on the housing portion 2, and the second connector 39b is arranged to connect to the second power terminal 33b on the housing portion 2. The power source 38 (e.g., a battery or a connection to an external power source (external battery or main power source)) is connected to the first connector 39a and the second connector 39b. Thus, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10. In some examples, the first power terminal 33a and the second power terminal 33b are conductive regions of the casing 2a that extend over a portion of the entire length of the casing 2a. Thereby, the housing portion 2 can move along the first needle 12 while maintaining contact with the first connector 39a and the second connector 39b on the first needle 12.

[0089] Alternatively, the delivery device 10 shown in FIG. 5A may be configured to implant the medical implant 1 shown in FIG. 3E that does not include the electrode lead wire 3. In this case, the second needle 13 may be omitted or provided only for puncturing the patient's tissue. Also in this case, as described above, the first connector 39a and the second connector 39b of the power supply system 37 are connected to the first power terminal 33a and the second power terminal 33b on the housing portion 2 of the medical implant 1, and power can be supplied to the medical implant 1 during implantation.

[0090] In the example of FIG. 5B, the delivery device 10 holds the medical implant 1 shown in FIG. 3B, and a first power terminal 36a and a second power terminal 36b are formed at one end of the housing portion 2. In this example, the power supply system 37 includes a first connector 40a and a second connector 40b disposed within the first needle 12. The first connector 40a is disposed to connect to the first power terminal 36a at the end of the housing portion 2, and the second connector 40b is disposed to connect to the second power terminal 36b at the end of the housing portion 2. The first connector 40a and the second connector 40b of the power supply system 37 may be provided on a contact block 41 fixed to the first needle 12. The power source 38 (for example, a battery or a connection portion to an external power source (external battery or main power source)) is connected to the first connector 40a and the second connector 40b. Thus, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10.

[0091] In another example similar to FIG. 5B, the contact block 41 may be clamped and fixed on the housing portion 2. In this case, the contact block 41 may be clamped and fixed on the housing portion 2 so as to form an electrical connection in the same manner as in the example of FIG. 5B and also to function to hold the housing portion 2 within the first needle 12. The contact block 41 may be unclamped from the housing portion 2 to allow retention of the housing portion 2 during implantation.

[0092] In the example of FIG. 5C, the delivery device 10 holds the medical implant 1 shown in any of FIGS. 3A - 3E. In these examples, the medical implant includes a wireless power receiver 35. In the specific example of FIG. 3C, the medical implant 1 also includes an additional (another) wireless power receiver 35a. In this example, the power supply system 37 includes a wireless power transmitter 42 disposed within the first needle 12 behind the housing portion 2. The power source 38 (e.g., a battery or a connection to an external power source (external battery or main power supply)) is connected to the wireless power transmitter 42, and during operation, power is wirelessly transmitted to the wireless power receivers 35, 35a within the medical implant 1. Thus, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10.

[0093] In another example similar to FIG. 5C, the wireless power transmitter 42 may be clamped and fixed on the housing portion 2. In this case, the wireless power transmitter 42 may be clamped and fixed on the housing portion 2 to align the wireless power transmitter 42 for power supply to the medical implant 1 while holding the housing portion 2 within the first needle 12. The wireless power transmitter 42 can be unclamped from the housing portion 2 to allow the housing portion 2 to remain in place during implantation.

[0094] FIG. 5D shows another example of a delivery device 10 similar to that of FIG. 5C. In this example, the wireless power transmitter 42 is housed within the second needle 13 at a position adjacent to the housing portion 2 within the first needle 12. The wireless power transmitter 42 may be aligned with the opening 18 (see FIG. 7) of the second needle 13, thereby enabling wireless power transmission to the housing portion 2. The wireless power transmitter 42 is preferably slidably housed within the second needle 13. The wireless power transmitter 42 is preferably fixed to the handle 11. Thereby, even if the second needle 13 is pulled back during implantation, the wireless power transmitter 42 will not move. The wireless power transmitter 42 may comprise an antenna formed of a coaxial cable with the shield removed from one end so as to form a transmission antenna aligned with the housing portion 2. The wireless power transmitter 42 is disposed adjacent to the wireless power receiver 35 and an additional wireless power receiver 35a within the housing portion 2. Thereby, the medical implant 1 can be powered while being housed within the delivery device 10. Therefore, the medical implant 1 can be inspected in situ prior to implantation from the delivery device 10.

[0095] Figure 5E shows another example of a delivery device 10 equipped with a wireless power transmitter. In this example, the wireless power transmitter includes a wireless power transmission antenna 43 disposed outside the first needle 12. The wireless power transmission antenna 43 covers the housing portion 2 within the first needle 12. The wireless power transmission antenna 43 is connected to a power source 38 (e.g., a battery or a connection to an external power source (external battery or main power supply)) and is operable to perform wireless power transmission to the wireless power receiver 35 and the additional wireless power receiver 35a within the housing portion 2. The first needle 12 may include an opening or a (non-metallic) transmission window to facilitate wireless power transmission. As shown in Figure 5E, the wireless power transmission antenna 43 may be slidable on the first needle 12. In particular, the wireless power transmission antenna 43 may be slidable from the illustrated position covering the housing portion 2 to a position retracted (stored position) towards the handle 11. Thereby, the wireless power transmission antenna 43 is arranged to supply power to the medical implant 1 when the electrode lead wire 3 is in a predetermined position, and then can be retracted (stored) to enable insertion of the first needle 12 into the patient's tissue. In some examples similar to Figure 5E, the wireless power transmission antenna 43 is made removable from the first needle 12. In these examples, instead of sliding the wireless power transmission antenna 43, the wireless power transmission antenna 43 may be a flexible (pliable) sheet or a foldable sheet. In this case, the sheet may be attachable to the first needle 12 to supply power to the medical implant 1 and may be removable from the first needle 12 when power supply to the medical implant 1 is not required.

[0096] Figure 5F shows a delivery device 10 of another example. In this example, the delivery device 10 includes a guide portion 90 configured to constrain (limit) the position and orientation of the delivery sheath with respect to the patient (in particular, the position and orientation of the second needle 13 during insertion into the patient's tissue). As shown in the figure, the guide portion 90 has a positioning portion 91. The positioning portion 91 is configured (e.g., shaped) to be disposed and / or attached at a specific position of the patient. The specific position of the patient varies depending on the target implantation site and can be any anatomical position (bone, joint, etc.). The guide portion 90 has a guide channel 92 through which at least a part of the delivery device 10 passes to constrain (limit) the position and orientation of the delivery sheath (the first needle 12 and the second needle 13) with respect to the patient. The delivery sheath (the first needle 12 and the second needle 13) is slidable along the guide channel 92 such that the second needle 13 and the first needle 12 are inserted into the patient's body in this order. In this example, it will be understood that the first needle 12 is constrained within the guide channel 92, but the second needle 13 may be additionally or alternatively constrained within the guide channel 92 or in another part of the delivery device 10 (e.g., the handle 11). With the assistance of the guide portion 90, advantageously, the operator can more easily place the electrode lead 3 percutaneously at the target implantation site (e.g., adjacent to the target nerve) or in its vicinity (periphery). The guide portion 90 is separable from the delivery device 10 during implantation and removable after the electrode lead 3 has been implanted.

[0097] As shown in the figure, the guide portion 90 includes a power supply system 37 configured (arranged) to supply power to the medical implant 1 within the delivery device 10. In this example, the power supply system 37 includes a power source 38 and a wireless power transmission transmitter 42 arranged to be adjacent to the housing portion 2 of the medical implant 1 during use. Thereby, as described above, the medical implant 1 can be powered within the delivery device 10 by the power supply system 37 within the guide portion 90 of the delivery device 10.

[0098] Figures 6A - 6C show the operation of any of the delivery devices 10 of Figures 5A - 5F.

[0099] As shown, an exemplary implant delivery device (delivery device 10) further includes a handle 11. The handle 11 is configured to be grippable by an operator. A first needle 12 is fixed to the handle 11.

[0100] A second needle 13 extends through the first needle 12 and the handle 11. An actuation tab (grip portion) 16 is provided at an end of the second needle 13 opposite the tip 15. In particular, the actuation tab 16 may be a grip handle or the like for the operator to grasp.

[0101] The second needle 13 is a retractable portion (storage portion) retractable (storable) with respect to the first needle 12. In particular, the second needle 13 is slidable through the first needle 12 and the handle 11 from the position shown in Figure 6A to the position shown in Figure 6B. In this example, by pulling the actuation 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 3 is placed. An opening 18 (see Figure 7) along the second needle 13 provides a connection portion of the electrode lead 3 with the housing portion 2. The opening 18 extends to the tip 15 of the second needle 13.

[0102] A locking device 17 is provided to lock the second needle 13 to the handle 11 and / or the first needle 12. As shown, the locking device 17 may be provided on the actuation tab 16 or in its vicinity (adjacent portion), and in some examples, locks the actuation tab 16 and / or the second needle 13 to the handle 11. The locking device 17 locks the second needle 13 in the position shown in Figure 6B (retracted position).

[0103] At the position shown in FIG. 6A, 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. Referring to FIGS. 6A 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, the first needle 12 penetrates the skin 5. Thereby, 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 the percutaneous delivery of the medical implant 1 into the patient's tissue. In some examples, the operator may use an ultrasonic imaging device to monitor the position of the second needle 13 (and the first needle 12) and guide the second needle 13 toward the target nerve 9. As will be further described below, the tissue bioimpedance at the electrode lead wire 3 may be detected to assist in positioning the electrode lead wire 3.

[0104] In some examples, the delivery device 10 may include a guide portion (for example, the guide portion 90 shown in FIG. 5F). The guide portion may be able to constrain (limit) the position and orientation of the second needle 13 and / or the first needle 12 during insertion.

[0105] When the delivery device 10 is placed at a predetermined position, the tip 15 of the second needle 13 (and the electrode lead wire 3 within the second needle 13) is placed near the nerve, and the tip 14 of the first needle 12 (and the housing portion 2 within the first needle 12) is placed within the subcutaneous tissue 7, the second needle 13 can be partially retracted (stored) to a position between the position shown in FIG. 6A and the position shown in FIG. 6B. In particular, the second needle 13 can be partially retracted to expose the electrode 4 (see FIGS. 3A - 3E). At this position (retracted position), the power supply system 37 (see FIGS. 5A - 5E) can supply power to the medical implant 1 so as to be able to inspect the position of the electrode 4 (see FIGS. 3A - 3E). If necessary, the second needle 13 can be extended again to the position shown in FIG. 6A and repositioned.

[0106] When the electrode lead wire 3 is properly positioned, the second needle 13 is retracted to the position shown in FIG. 6B and the electrode lead wire 3 is left in place. In some examples, the electrode lead wire 3 may include one or more anti - displacement parts (anti - migration parts, anti - movement parts). The anti - displacement part is left in place when the second needle 13 is retracted and functions to hold the electrode lead wire 3 in a predetermined position.

[0107] 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 lock device 17 (locking mechanism) and slide the second needle 13 to the retracted position (stored position) shown in FIG. 6B. 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 in the figure, when the second needle 13 is retracted, the electrode lead wire 3 is left in place and exposed to the surrounding tissue (and nerve).

[0108] In some examples where a guide part is used (see FIG. 5F), the guide part may be removed before or after the retraction of the second needle 13.

[0109] Next, as shown in FIG. 6C, the delivery device 10 is withdrawn from the patient's body, and the housing portion 2 is left on the first needle 12. In this example, the friction between the electrode lead wire 3 and the tissue (see the muscle 8 in FIG. 2) is sufficient to hold the medical implant 1 in place when the delivery device 10 is withdrawn. Thereby, when the delivery device 10 is withdrawn from the patient's body, the housing portion 2 is left on the first needle 12. In some examples, the electrode lead wire 3 includes one or more anti-displacement portions. The anti-displacement portion functions to hold the electrode lead wire 3 in place and to pull the housing portion 2 off the first needle 12.

[0110] In other examples, the delivery device 10 may include a retention member (e.g., a pusher within the first needle 12) configured to push the housing portion 2 off the first needle 12. In some examples, the delivery device 10 may have a retention member configured to removably attach the housing portion 2 to the first needle 12 and / or the handle 11. The retention member may release the housing portion 2 after the second needle 13 is retracted and before the first needle 12 is removed from the patient's body.

[0111] FIGS. 7, 8A, and 8B show the first needle 12 and the second needle 13 in the above-described delivery device 10. As shown, the electrode lead wire 3 is received within the second needle 13, and the second needle 13 has a slot (opening 18) for connecting the electrode lead wire 3 to the housing portion 2 within the first needle 12. The slot (opening 18) extends partially along the second needle 13 from the tip 15 and may extend over most or the entire length of the second needle 13. The second needle 13 may have a sheath shape. The first needle 12 houses the housing portion 2.

[0112] The first needle 12 has a beveled tip 14. The second needle 13 has a beveled tip 15. The beveled tips 14, 15 are sharpened so as to be able to pierce the patient's skin and penetrate the tissue during use.

[0113] As shown in FIG. 7, the second needle 13 extends through the lumen of the first needle 12. In particular, as shown in FIG. 8B, 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.

[0114] 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.

[0115] 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 13 and has a substantially circular cross-section that holds the second needle 13 in an axially aligned state within the second portion 19B.

[0116] 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 examples, 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.

[0117] The slot (opening 18) of the second needle 13 opens toward the center of the first needle 12. Thereby, as shown in FIG. 7, the electrode lead wire 3 can be connected to the housing portion 2.

[0118] 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. When the second needle 13 is positioned within the lumen of the first needle 12, during use, the puncture wound formed by the second needle 13 will be enlarged by the first needle 12, which is advantageous in that only one puncture wound is formed on the patient's skin.

[0119] In another example, the second needle 13 does not pass through or through 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).

[0120] In the above example, the second needle 13 is initially in the extended or retracted position, and the first needle 12 and the second needle 13 may be simultaneously placed within the patient. FIG. 9 shows another example where the second needle 13 is initially in the retracted position. In this example, as shown, the actuating tab 16 extends from the handle 11. In the retracted position, the second needle 13 is either within the first needle 12 as shown, or alongside the first needle 12 within the handle 11. The electrode lead wire 3 is partially within the second needle 13 and is arranged in a loop between the housing portion 2 and the second needle 13.

[0121] During implantation, when the first needle 12 is inserted into the patient's body using the delivery device 10 in the form shown in FIG. 9, next, by pushing the actuating tab 16 toward the handle 11, the second needle 13 is extended beyond the first needle 12 to carry the electrode lead wire 3 to a predetermined position. At this position, by engaging the locking device 17 (locking mechanism), the actuating tab 16 and the second needle 13 can be locked in place.

[0122] In some examples, the delivery device 10 may be removed from the patient with the second needle 13 in the extended position, and a retention member (e.g., a pusher) may be provided to extrude the medical implant 1 from the first needle 12 and the second needle 13. In other examples, after the second needle 13 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. 6A-6C, whereby the electrode lead 3 and the housing portion 2 are released.

[0123] 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.

[0124] 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 the retraction of the second needle 13 (i.e., moves the second needle 13 in a direction opposite to the actuation tab 16).

[0125] 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 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, may be mounted 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, releasing the electrode lead wire 3. Further, when the operating tab 16 is pushed toward the patient, the second rack portion 30B engages the housing portion 2 and pushes the housing portion 2, whereby the housing portion 2 can be retained from the first needle 12.

[0126] In some examples, the delivery device 10 may include a locking mechanism operable to lock the first rack portion 30A to the second rack portion 30B. When locked, the second needle 13 can be pushed into the patient's tissue without rotating the rack and pinion mechanism. Next, the locking mechanism can be unlocked and the second needle 13 can be retracted. The locking mechanism may be operable to lock the first rack portion 30A and / or the second rack portion 30B to the handle 11 or may be operable to lock the rotation of the pinion gear 31. The locking mechanism may be operable at different positions of the second needle 13, whereby the position of the second needle 13 can be locked at various positions between the fully extended position and the fully retracted position. In some examples, the locking mechanism may be configured to lock the second needle 13 in the fully extended position. In other examples, the locking mechanism may further be operable to lock the second needle 13 in a partially retracted position.

[0127] Advantageously, the delivery device 10 may be operable with one hand by pushing the actuating tab 16 rather than pulling it.

[0128] Figs. 11A - 11C show an alternative delivery device 10. In this example, the delivery device 10 comprises a handle 11, a first needle 12 holding the housing part 2, and a second needle 13 holding the electrode lead wire 3, as described above.

[0129] As shown in Figs. 11A and 11B, in this example, prior to use, the electrode lead wire 3 extends from the end of the housing part 2 facing the handle 11. The electrode lead wire 3 is routed into the second needle 13 via above the housing part 2 within the first needle 12. A part of the electrode lead wire 3 is arranged along the housing part 2 within the first needle 12.

[0130] The first needle 12 has a notch 12a as most clearly shown in Figs. 11B and 11C. The notch 12a extends from the tip 14 of the first needle 12 above the housing part 2 and accommodates the portion of the electrode lead wire 3 adjacent to the housing part 2 within the first needle 12 prior to use. The width of the notch 12a is wider than the width of the electrode lead wire 3 and narrower than the width of the housing part 2. Therefore, the housing part 2 is held within the first needle 12.

[0131] As shown in FIG. 11C, during use, after the second needle 13 is retracted into the first needle 12 and the tip of the electrode lead wire 3 is retained (as described above with reference to FIG. 6B), before the housing portion 2 is retained from the first needle 12 (as described above with reference to FIG. 6C), the angle of the delivery device 10 (including the first needle 12) can be changed. As shown in FIG. 11C, when the angle is changed, a portion of the electrode lead wire 3 exits the first needle 12 through the notch 12a. Thereby, the end of the electrode lead wire 3 can be implanted at a first angle, and the housing portion 2 can be implanted at a second angle different from the first angle. 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), or may be advantageous for making the medical implant better conform to the anatomical structure of the implantation site.

[0132] Similar to the example of FIG. 10, in the examples of FIGS. 11A - 11C, the actuating tab 16 is configured (arranged) to be pushed toward the handle 11 (and the patient) to retract the second needle 13. The delivery device 10 includes a rack and pinion mechanism that converts the movement of the actuating tab 16 in the direction toward the handle 11 into the retraction of the second needle 13. That is, by the rack and pinion mechanism, the second needle 13 moves in a direction opposite to the actuating tab 16.

[0133] As shown in Fig. 11A, the rack and pinion mechanism includes a first rack portion 30A 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 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 draws the second needle 13 away from the patient, releasing the electrode lead wire 3. Further, when the actuating tab 16 is pushed toward the patient, the second rack portion 30B engages the housing portion 2 and pushes the housing portion 2 in, allowing the housing portion 2 to be retained from the first needle 12.

[0134] Advantageously, by pushing the actuating tab 16 rather than pulling it, the delivery device 10 can be operated with one hand.

[0135] The exemplary delivery device described above with reference to FIGS. 9 to 11C includes a power supply system 37 as described above with reference to FIGS. 5A to 5E. In particular, the power supply system 37 includes a power source 38. In some examples, as described above with reference to FIGS. 5A and 5B, the power supply system 37 includes connectors 39a, 39b, 40a, 40b arranged to connect to corresponding power supply terminals 33a, 33b, 36a, 36b on the housing part 2. In other examples, the power supply system 37 includes a wireless power supply transmitter 42 configured (arranged) to provide wireless power supply to wireless power supply receivers 35, 35a within the housing part 2 as described above with reference to FIGS. 5C to 5E. In one example, the wireless power supply transmitter 42 is attached to the second rack part 30B so as to be moved to the vicinity (adjacent part) of the housing part 2 when the second needle 13 is retracted. Thereby, it becomes possible to supply power to the medical implant 1 and inspect the position of the electrode lead wire 3.

[0136] FIGS. 12A to 12D show another example of a delivery device 10 including the same power supply system 37 as described above. In particular, FIGS. 12A to 12D show a delivery device 10 (delivery system) including a delivery sheath, and the delivery sheath is composed of a cannula 53 that holds the medical implant 1 before and during implantation. The entire medical implant 1 may be any of the medical implants 1 described above with reference to FIGS. 3A to 3E and is held within the cannula 53. The cannula 53 can be disposed percutaneously. The medical implant 1 can be implanted from the cannula 53 by a pusher 54, for example, as shown.

[0137] In the example of FIG. 12A, the delivery device 10 (delivery system) is configured to be able to implant the medical implant 1 described above with reference to FIG. 3A, and the housing portion 2 includes a first power supply terminal 33a and a second power supply terminal 33b formed on the side wall. It will be understood that the delivery device 10 of FIG. 12A can also be used for the medical implant 1 shown in FIG. 3D. As shown in the figure, the power supply system 37 includes a first connector 55a and a second connector 55b disposed within the cannula 53. The first connector 55a is configured (arranged) to be connectable to the first power supply terminal 33a on the housing portion 2, and the second connector 55b is configured (arranged) to be connectable to the second power supply terminal 33b on the housing portion 2. By the first connector 55a and the second connector 55b, the medical implant 1 can slide a small distance within the cannula 53 while maintaining electrical contact. Thus, the medical implant 1 can be partially pushed out of the cannula 53 to expose the electrode 4 before the power supply system 37 is operated to inspect the position of the electrode lead wire 3 as described above. In particular, since the first power supply terminal 33a and the second power supply terminal 33b on the housing portion 2 of the medical implant 1 extend along a part of the length of the housing portion 2, the housing portion 2 can move along the cannula 53 and electrical contact is maintained. A power source 38 (for example, a battery or a connection portion to an external power source (external battery or main power source)) is connected to the first connector 55a and the second connector 55b. Therefore, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10.

[0138] Alternatively, the delivery device 10 shown in FIG. 12A may be configured to be able to implant the medical implant 1 shown in FIG. 3E that does not include the electrode lead wire 3. In this case, by connecting the first connector 55a and the second connector 55b of the power supply system 37 to the first power supply terminal 33a and the second power supply terminal 33b on the housing portion 2 of the medical implant 1, it becomes possible to supply power to the medical implant 1 during implantation as described above.

[0139] In the example of FIG. 12B, the delivery device 10 (delivery system) is configured to be able to implant the medical implant 1 described above with reference to FIG. 3B, and the housing portion 2 includes a first power supply terminal 36a and a second power supply terminal 36b formed at one end thereof. As shown in the figure, the power supply system 37 includes a first connector 56a and a second connector 56b disposed within the cannula 53. The first connector 56a is configured (arranged) to be connectable to the first power supply terminal 36a on the housing portion 2, and the second connector 56b is configured (arranged) to be connectable to the second power supply terminal 36b on the housing portion 2. A power supply 38 (for example, a battery or a connection portion to an external power supply (external battery or main power supply)) is connected to the first connector 56a and the second connector 56b. Therefore, the medical implant 1 can be powered by the power supply 38 while it is within the delivery device 10. In this example, the power supply 38, the first connector 56a, and the second connector 56b are formed on a mount (pedestal portion) 57 that is slidable within the cannula 53. Thereby, the pusher 54 can push the mount 57 and the medical implant 1 toward the outlet of the cannula 53, and the power connection between the first power supply terminal 36a and the second power supply terminal 36b and the first connector 56a and the second connector 56b is maintained. Alternatively, the mount 57 may be fixed within the cannula 53, and the pusher 54 may pass through the mount 57 or its surroundings so as to contact the housing portion 2 of the medical implant 1.

[0140] In the example of FIG. 12C, the delivery device 10 (delivery system) is configured to be able to implant the medical implant 1 described above with reference to FIG. 3C, and the housing portion 2 includes a wireless power receiving device 35a. Additionally or alternatively, the delivery device 10 of FIG. 12C may be used with a medical implant 1 having a single wireless power receiving device 35 and does not require additional connectors or the like.

[0141] As shown in FIG. 12C, the power supply system 37 includes a wireless power supply transmitter 58 disposed within the cannula 53 so as to be wirelessly connected (wirelessly coupled) to the wireless power supply receivers 35, 35a of the medical implant 1. The wireless power supply transmitter 58 is connected to a power source 38. The power source 38 may be disposed outside the cannula 53 (e.g., within the handle 11). In some examples, the wireless power supply transmitter 58 may be connected to the power source 38 by electrical connectors 59a, 59b. The electrical connectors 59a, 59b allow the wireless power supply transmitter 58 to slide a small distance within the cannula 53. Thereby, the medical implant 1 can be partially pushed out of the cannula 53 so as to expose the electrode 4 before the power supply system 37 is operated to inspect the position of the electrode lead 3 as described above. Alternatively, the wireless power supply transmitter 58 may be fixed within the cannula 53, and the pusher 54 may pass through the wireless power supply transmitter 58 or its surroundings so as to contact the housing portion 2 of the medical implant 1. The power source 38 may be a battery or a connection to an external power source (external battery or main power source). Thus, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10.

[0142] In the example of FIG. 12D, the delivery device 10 (delivery system) is configured to be able to implant the medical implant 1 described above with reference to FIG. 3C, and the housing portion 2 includes a wireless power supply receiver 35a. Additionally or alternatively, the delivery device 10 of FIG. 12D may be used with a medical implant having a single wireless power supply receiver 35 and does not require additional connectors or the like.

[0143] As shown in FIG. 12D, the power supply system 37 includes a wireless power supply transmitter 58 disposed in the cannula 53 so as to be wirelessly connected (wirelessly coupled) to the wireless power supply receivers 35, 35a of the medical implant 1. The wireless power supply transmitter 58 is connected to a power source 38. The power source 38 may be a battery or a connection to an external power source (external battery or main power source). In this example, the power source 38 and the wireless power supply transmitter 58 are formed on a slide-type mount (pedestal portion) 59 that is slidable within the cannula 53. Thereby, the pusher 54 can push the slide-type mount 59 and the medical implant 1 toward the outlet of the cannula 53, and the wireless power supply connection can be maintained. In this way, the electrode 4 is exposed, and power can be supplied to the medical implant 1 to inspect the position of the electrode lead 3 before implantation.

[0144] In some examples, the cannula 53 described above with reference to FIGS. 12A-12D may be, for example, a needle having an angled tip.

[0145] Figs. 13A to 13C show another example of the delivery device 10 including the above-described power supply system 37. In particular, Figs. 13A to 13D show a delivery device 10 (delivery system) including a delivery sheath including a wedge-shaped needle. The wedge-shaped needle has a first portion 61 that holds the housing portion 2 of the medical implant 1 and a second portion 62 that protrudes from the first portion 61 and holds the electrode lead wire 3. The first portion 61 and the second portion 62 are fixed to each other and have different diameters (the diameter of the second portion 62 is smaller than the diameter of the first portion 61). The second portion 62 has a slot extending over its entire length. The slot of the second portion 62 extends from the first portion 61 to the tip of the second portion 62. The first portion 61 also has a slot or opening on the side that is aligned (lined up in a straight line) with the slot of the second portion 62. Thereby, when the pusher 54 pushes out the housing portion 2 from the first portion 61 through the slot or opening, the medical implant 1 can be implanted, and the delivery device 10 can be retracted so as to completely embed the medical implant 1.

[0146] In the example of FIG. 13A, the delivery device 10 (delivery system) is configured to be able to embed the medical implant 1 described above with reference to FIG. 3A, and the housing portion 2 includes a first power supply terminal 33a and a second power supply terminal 33b formed on the side wall. It will be understood that the delivery device 10 of FIG. 13A can also be used for the medical implant shown in FIG. 3D. As shown in the figure, the power supply system 37 includes a first connector 60a and a second connector 60b disposed in the first portion 61 of the delivery device 10. The first connector 60a is configured (arranged) to be connectable to the first power supply terminal 33a on the housing portion 2, and the second connector 60b is configured (arranged) to be connectable to the second power supply terminal 33b on the housing portion 2. By the first connector 60a and the second connector 60b, the medical implant 1 can slide a small distance within the first portion 61 while maintaining electrical contact. Thus, the electrode lead wire 3 can be partially pushed out from the second portion 62 so as to expose the electrode 4 before the power supply system 37 is operated to inspect the position of the electrode lead wire 3 as described above. In particular, since the first power supply terminal 33a and the second power supply terminal 33b on the housing portion 2 of the medical implant 1 extend along a part of the length of the housing portion 2, the housing portion 2 can move along the first portion 61 and electrical contact is maintained. The power supply 38 (for example, a battery or a connection to an external power supply (external battery or main power supply)) is connected to the first connector 60a and the second connector 60b. Therefore, the medical implant 1 can be powered by the power supply 38 while it is within the delivery device 10.

[0147] Alternatively, the delivery device 10 shown in FIG. 13A may be configured to be capable of implanting the medical implant 1 shown in FIG. 3E without the electrode lead wires 3. In this case, the second portion 62 may be omitted or provided only for puncturing the patient's tissue. The first connector 60a and the second connector 60b of the power supply system 37 are connected to the first power supply terminal 33a and the second power supply terminal 33b on the housing portion 2 of the medical implant 1, whereby, as described above, power can be supplied to the medical implant 1 during implantation.

[0148] In the example of FIG. 13B, the delivery device 10 (delivery system) is configured to be capable of implanting the medical implant 1 described above with reference to FIG. 3B, and the housing portion 2 includes the first power supply terminal 36a and the second power supply terminal 36b formed at one end thereof. As shown in the figure, the power supply system 37 includes the first connector 60a and the second connector 60b disposed in the first portion 61. The first connector 60a is configured (arranged) to be connectable to the first power supply terminal 36a on the housing portion 2, and the second connector 60b is configured (arranged) to be connectable to the second power supply terminal 36b on the housing portion 2. A power source 38 (for example, a battery or a connection portion to an external power source (external battery or main power source)) is connected to the first connector 63a and the second connector 63b. Therefore, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10. In this example, the first connector 63a and the second connector 63b are formed on a mount (pedestal portion) that is slidable within the first portion 61. Thereby, the pusher 54 can push the mount and the medical implant 1 toward the opening of the first portion 61, and the power connection between the first power supply terminal 36a and the second power supply terminal 36b and the first connector 63a and the second connector 63b is maintained. Alternatively, the mount may be fixed within the first portion 61, and the pusher 54 may pass through the mount or its surroundings so as to contact the housing portion 2 of the medical implant 1.

[0149] In the example of FIG. 13C, the delivery device 10 (delivery system) is configured to be able to implant the medical implant 1 described above with reference to FIG. 3C, and the housing portion 2 includes a wireless power receiver 35a. Additionally or alternatively, the delivery device 10 of FIG. 13C may be used with a medical implant 1 having a single wireless power receiver 35 and does not require additional connectors or the like.

[0150] As shown in FIG. 13C, the power supply system 37 includes a wireless power transmitter 64 disposed in the first portion 61 so as to wirelessly connect (wirelessly couple) with the wireless power receivers 35, 35a of the medical implant 1. The wireless power transmitter 64 is connected to a power source 38. In this example, the power source 38 is disposed within the handle 11. The power source 38 may be a battery or a connection to an external power source (external battery or main power source). Thus, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10. The wireless power transmitter 64 may be moved by the pusher 54 during the implantation of the medical implant 1, or may have a shape that allows the pusher 54 to pass through or around the wireless power transmitter 64 within the first portion 61 so that the pusher 54 contacts the housing portion 2 of the medical implant 1.

[0151] Figures 14A and 14B show a delivery device 10 of another example including the power supply system 37 described above. In particular, FIGS. 14A-14B show a delivery device 10 (delivery system) used to implant the electrode lead 3 after first implanting the housing portion 2 of the medical implant 1. As shown, this delivery device 10 includes a delivery sheath having a first needle 65 that holds the housing portion 2 of the medical implant 1 and a second needle 66 that holds the electrode lead 3. The second needle 66 is extendable and retractable relative to the first needle 65 as described above with reference to FIGS. 6A-6C. The housing portion 2 is disposed within the first needle 65 such that the electrode lead 3 is directed away from the tip 67 of the first needle 65. The electrode lead 3 is bent in a loop and received in the second needle 66 having a slot (opening 18) as shown in FIG. 7. During use, the first needle 65 is positioned percutaneously to implant the housing portion 2, and a pusher (not shown) or the second needle 66 is used to at least partially implant (deploy) the housing portion 2 through the tip 67. Once the housing portion 2 is at least partially implanted (deployed), the second needle 66 can be extended to implant the electrode lead 3. Next, the second needle 66 can be retracted to leave the electrode lead 3 in a predetermined position. During implantation, to inspect the position of the electrode lead 3, the second needle 66 is partially retracted to expose the electrode 4, and the power supply system 37 can be operated to supply power to the medical implant 1.

[0152] In the example of FIG. 14A, the delivery device 10 (delivery system), which was described above with reference to FIG. 3A and is configured to be able to implant the medical implant 1, has a housing part 2 provided with a first power supply terminal 33a and a second power supply terminal 33b formed on the casing of the housing part 2. It will be understood that the delivery device 10 of FIG. 13A can also be used for the medical implant shown in FIG. 3D. As shown in the figure, the power supply system 37 includes a first connector 68a and a second connector 68b disposed within the first needle 65 of the delivery device 10. The first connector 68a is configured (arranged) to be connectable to the first power supply terminal 33a on the housing part 2, and the second connector 68b is configured (arranged) to be connectable to the second power supply terminal 33b on the housing part 2. By means of the first connector 68a and the second connector 68b, the medical implant 1 can slide a small distance within the first needle 65 while maintaining electrical contact. Thus, before the power supply system 37 is operated to inspect the position of the electrode lead wire 3 as described above, the housing part 2 can be partially pushed out from the first needle 65. In particular, since the first power supply terminal 33a and the second power supply terminal 33b on the housing part 2 of the medical implant 1 extend along a part of the length of the housing part 2, the housing part 2 can move along the first needle 65 and electrical contact is maintained. A power source 38 (for example, a battery or a connection part to an external power source (external battery or main power source)) is connected to the first connector 68a and the second connector 68b. Therefore, the medical implant 1 can be powered by the power source 38 during implantation.

[0153] Alternatively, the delivery device 10 shown in FIG. 14A may be configured to implant the medical implant 1 shown in FIG. 3E without the electrode lead wire 3. In this case, the second needle 66 may be omitted or provided only for puncturing the patient's tissue. The first connector 68a and the second connector 68b of the power supply system 37 are connected to the first power supply terminal 33a and the second power supply terminal 33b on the housing portion 2 of the medical implant 1. Thereby, as described above, power can be supplied to the medical implant 1 during implantation.

[0154] In the example of FIG. 14B, the delivery device 10 (delivery system) is configured to implant the medical implant 1 described above with reference to FIG. 3C, and the housing portion 2 includes a wireless power receiving unit 35a. Additionally or alternatively, the delivery device 10 of FIG. 14B may be used with a medical implant having a single wireless power receiving unit 35 and does not require additional connectors or the like.

[0155] As shown in FIG. 14B, the power supply system 37 includes a wireless power transmitter 69 disposed within the handle 11 for wireless connection (wireless coupling) with the wireless power receiving units 35, 35a of the medical implant 1. The wireless power transmitter 69 is connected to a power source 38. In this example, the power source 38 is disposed within the handle 11. The power source 38 may be a battery or a connection to an external power source (external battery or main power source). Thus, the medical implant 1 can be powered by the power source 38 while it is within the delivery device 10.

[0156] FIG. 15 shows the operation of inspecting the medical implant 1 during implantation using any of the delivery devices 10 described above with reference to FIGS. 5A-14B. Each example delivery device 10 includes a delivery sheath that holds the medical implant 1 and a power supply system 37 that supplies power to the medical implant 1 within the delivery sheath. FIG. 15 shows a particular exemplary delivery device 10 of FIGS. 3A-9, but it will be understood that the same inspection process can be used for any of the delivery devices 10 described herein.

[0157] As shown in FIG. 15, the delivery sheath (in this example, the first needle 12 and the second needle 13) is percutaneously placed within the tissue (muscle 8) through the patient's skin 5. The electrode 4 (in this example, the electrode 4 on the electrode lead 3) is guided in the vicinity of the nerve 9, for example, using an ultrasonic scanner. In this example, the electrode 4 is exposed by partially retracting the second needle 13. At this position, by operating the power supply system 37, it becomes possible to supply power to the medical implant 1 and inspect the position of the electrode 4 relative to the nerve 9.

[0158] In some examples, the medical implant 1 is a nerve stimulation implant operable to stimulate the nerve 9 by providing an electrical signal through the electrode 4. In this example, by inspecting the position of the nerve stimulation implant, it becomes possible to confirm that the electrical signal provided by the electrode 4 brings about the desired effect on the nerve 9.

[0159] In some examples, an operator may use visual feedback or feedback from a patient to determine whether the medical implant 1 is achieving the desired effect. For example, if the medical implant 1 is being used to treat sleep apnea, visual feedback may include the position of the tongue (e.g., the degree of tongue protrusion). Other visual feedback or feedback from the patient may include a tactile examination of the patient (for testing sensation) or feedback from the patient regarding the severity of pain or a tingling sensation. In one example, the medical implant 1 may be implanted to address signs of urination, in which case visual feedback may be provided by urination.

[0160] As shown in FIG. 15, the delivery device 10 may include a sensor 45. In the illustrated example, the sensor 45 is attachable to a patient (specifically, the patient's skin 5). The sensor may be adhered to the skin 5 or held in place by, for example, straps or wearables. In other examples, the sensor 45 may be provided within the delivery device 10 itself (e.g., within the handle 11). In other examples, the sensor 45 may be provided in a wearable device associated with the nerve stimulation implant (e.g., a wearable device that provides wireless power and control after implantation is complete). In some examples, the sensor 45 may be provided in the medical implant 1.

[0161] Sensor 45 is provided to detect the patient's reaction when power is supplied to the nerve stimulation implant 1 during implantation. In some examples, sensor 45 may detect the patient's movement (motion) response to the inspection of nerve stimulation implant 1. The movement response may be detected by an accelerometer (e.g., a microelectromechanical system (MEMS) sensor), an electromyogram (EMG) sensor, or an ultrasonic sensor. In other examples, sensor 45 may detect changes in the patient's blood flow, for example, using an ultrasonic sensor or other blood flow sensors. In some examples, sensor 45 may be a bioimpedance type impedance blood pressure sensor and may be integrated with electrode 4 of medical implant 1. In some examples, sensor 45 may be a blood pressure sensor using radar. In some examples, sensor 45 may detect the position of a body part. For example, when treating sleep apnea, sensor 45 may detect the position of the tongue.

[0162] In some examples, the medical implant is a diagnostic implant 1 operable to detect nerve signals within a nerve. In other examples, diagnostic implant 1 may detect one or more patients' vital signs (e.g., body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentration (oxygen, carbon dioxide, carbon monoxide, etc.)). In this case, to detect nerve signals, the position of diagnostic implant 1 may be inspected to confirm that electrode 4 is correctly positioned relative to nerve 9.

[0163] In an example such as the above, the delivery device 10 (delivery system) for the diagnostic implant 1 may include a sensor 45 as shown in FIG. 15. In the illustrated example, the sensor 45 is attachable to a patient (particularly, the patient's skin 5). The sensor 45 may be attached to the skin 5 or may be held in a predetermined position by, for example, a strap or a wearable. In other examples, the sensor 45 may be provided within the delivery device 10 itself (e.g., within the handle 11). In other examples, the sensor 45 may be provided in a wearable device associated with the nerve stimulation implant (e.g., a wearable device that provides wireless power supply and control after implantation is complete).

[0164] In some examples, the sensor 45 may detect the same nerve signals as the diagnostic implant 1 in order to examine the diagnostic implant 1. For example, the sensor 45 may be configured to detect one or more nerve signals (e.g., action potentials (nerve impulses), electrical impedance within tissue, nerve responses (e.g., nerve response amplitude), electrical interference, motor neuron responses (e.g., using electromyogram (EMG)), electro-dermal activity (EDA), and / or signals including heart rate characteristics (e.g., using electrocardiogram (ECG))). In other examples, the diagnostic implant may detect one or more patient vital signs (e.g., body temperature, heart rate, respiratory rate, blood pressure, and / or blood gas concentrations (oxygen, carbon dioxide, carbon monoxide, etc.)).

[0165] As shown in FIG. 15, the delivery device 10 may also include a controller 46. The controller 46 may be embedded within the handle 11 or may be provided separately, for example, in another device. The controller 46 is communicable with the sensor 45 and the power supply system 37. The communication is provided by a communication channel 44 (a wired connection or a wireless communication channel).

[0166] The controller 46 may be configured to control the power supply system 37. For example, the power supply system 37 may be controlled to supply power to the medical implant 1 according to an instruction to the controller 46 by user input. The user input may be provided via a button or switch on the delivery device 10, or may be provided via a graphical user interface (GUI) 43 as shown in the figure.

[0167] In some examples, the controller 46 may be configured to control the power supply system 37 to supply power to the medical implant 1 based on (in response to) the characteristics detected by the sensor 45. In particular, the controller 46 may be configured to supply power to the medical implant via the power supply system 37 and to inspect the position of the medical implant 1 by evaluating the position of the medical implant 1 using data from the sensor 45. The controller 46 may be configured to increase or decrease the power supplied to the medical implant 1 according to the characteristics detected by the sensor 45. The controller 46 may further perform direct wireless communication with the medical implant 1 to control the medical implant 1 during inspection.

[0168] As shown in FIG. 15, the delivery device 10 may further include a graphical user interface (GUI) 43. The graphical user interface (GUI) 43 may be attached to the handle 11 or may be provided separately. The graphical user interface (GUI) 43 may be communicable with the controller 46 and may be controlled by the controller 46. The controller 46 may display one or more of the following information on the graphical user interface (GUI) 43. Characteristics of the power supplied to the medical implant (e.g., frequency, voltage, current) Operating characteristics of the medical implant (e.g., frequency, amplitude) One or more characteristics detected by the sensor 45 One or more thresholds of the characteristics detected by the sensor 45

[0169] In some examples, the controller 46 causes an overlay or comparison of the operating characteristics of the medical implant 1 and the data received from the sensor 45 to be displayed on the graphical user interface (GUI) 43. Such an overlay or comparison indicates the effectiveness of the placement and operation of the medical implant 1.

[0170] In some examples, the delivery device 10 may include a user input device (e.g., a button or switch). In one example, the graphical user interface (GUI) 43 is a touch screen device operable as a user input device. In response to user input via the user input device, the controller 46 may be configured to execute an inspection program, for example, by supplying power to the medical implant 1 and detecting the patient's characteristics by the sensor 45.

[0171] In some examples, the graphical user interface (GUI) 43 may include an input section for patient feedback and / or an input section for visual feedback. For example, the graphical user interface (GUI) 43 may include an input section for the user to input an assessment of the patient's pain or tingling sensation. In some examples, the graphical user interface (GUI) 43 may include a user input section for inputting information regarding feedback, for example, to evaluate or confirm the effectiveness of the position of the medical implant 1. In other examples, the graphical user interface (GUI) 43 may include a user input section for confirming that feedback has been observed.

[0172] Figures 16 to 19 show a delivery device 10 of another example. In these examples, the delivery device 10 is provided with an impedance sensor system 47 configured to detect a change in tissue type at or near the tip of the delivery sheath by measuring the electrical impedance, as described below.

[0173] Figure 16 shows an example based on the delivery device 10 described above with reference to FIGS. 5A to 11B. In this example, the delivery device 10 includes a delivery sheath that holds a first needle 12 for holding the housing portion 2 of the medical implant 1 and a second needle 13 for holding the electrode lead wire 3. It will be understood that the impedance sensor system 47 described below may be used in combination with the power supply system 37 described above with reference to FIGS. 5A to 5E, or the power supply system 37 may be omitted.

[0174] As shown in FIG. 16, the impedance sensor system 47 includes a first electrode 48 disposed at or near the tip 15 of the second needle 13. The first electrode 48 is connected to an impedance analyzer 50 disposed, for example, within the handle 11. The first electrode 48 may be a separate component attached to the second needle 13, or the second needle 13 may include an electrically insulating coating having an opening that exposes a part of the second needle 13 to define the first electrode 48.

[0175] The impedance sensor system 47 also includes a second electrode 49 disposed to contact the patient at a position away from the first electrode 48. In the illustrated example, the second electrode 49 can be disposed (e.g., adhesively) with respect to the patient's skin 5. However, the second electrode 49 may protrude from the handle 11, may be provided on the first needle 12, or may be provided on the second needle 13 in an electrically insulated state spaced apart from the first electrode 48.

[0176] Both the first electrode 48 and the second electrode 49 are connected to an impedance analyzer 50 that detects the electrical impedance between the first electrode 48 and the second electrode 49. The electrical impedance may indicate the tissue type in the vicinity (periphery) of the first electrode 48, i.e., at the tip 15 of the second needle 13. For example, the detected electrical impedance may be a first value when the first electrode 48 is in the subcutaneous tissue 7, a second value when the first electrode 48 is in the muscle 8, and a third value when the first electrode 48 is in the vicinity (periphery) of the nerve 9. Therefore, the detected electrical impedance can indicate the position of the first electrode 48 (and the tip 15 of the second needle 13) within the patient's tissue.

[0177] Since the tissue boundary is particularly prominent when detecting the electrical impedance, the change in the detected electrical impedance can be used to determine the position of the tip 15 of the second needle 13 relative to the tissue boundary. In some examples, the detected electrical impedance may be used to determine that the tip 15 of the second needle 13 is approaching the nerve 9.

[0178] In some examples, the detected electrical impedance may be used in combination with ultrasound to guide the second needle 13 to an appropriate implantation position. In particular, using ultrasound makes it possible to guide the second needle 13 through the skin 5 and muscle 8 towards the nerve 9, and using the detected electrical impedance makes it possible to determine whether the tip 15 of the second needle 13 is at an appropriate distance from the nerve 9. The detected electrical impedance can help prevent the second needle 13 from puncturing the nerve 9.

[0179] As shown in FIG. 16, impedance analyzer 50 is communicable with controller 51. Controller 51 can analyze the detected electrical impedance determined by impedance analyzer 50. Controller 51 and impedance analyzer 50 may be a single component. Delivery device 10 may include a graphical user interface (GUI) 52 that communicates with controller 51. Controller 51 may display the detected electrical impedance on graphical user interface (GUI) 52. Controller 51 may display one or more thresholds of the electrical impedance on graphical user interface (GUI) 52. Controller 51 may display the history of the detected electrical impedance on graphical user interface (GUI) 52 when the first electrode 48 passes through the patient's skin 5 and tissue. Controller 51 may compare the detected electrical impedance with a database or other comparable (comparable) data, whereby, for example, it becomes possible to determine tissue type or anatomical features based on the detected electrical impedance (specifically, changes in the detected electrical impedance). The database or comparable data may be provided at a distributed location (e.g., a server, etc.), and impedance analyzer 50 may communicate via a wireless communication channel (e.g., the Internet, etc.).

[0180] FIG. 17 shows another example of delivery device 10 (delivery system) including impedance sensor system 47. This example is based on delivery device 10 described above with reference to FIGS. 12A-12D, and delivery device 10 includes a delivery sheath that includes cannula 53 that holds medical implant 1. It will be understood that the impedance sensor system 47 described below may be used in combination with the power supply system 37 described above with reference to FIGS. 12A-12D, or the power supply system 37 may be omitted.

[0181] As shown in FIG. 17, the cannula 53 includes a first electrode 48 formed at the tip 70 of the cannula 53 or in its vicinity (periphery). The first electrode 48 may be a separate component attached to the cannula 53, or the cannula 53 may include an electrically insulating coating having an opening that exposes a part of the cannula 53 to define the first electrode 48.

[0182] The impedance sensor system 47 also includes a second electrode 49 disposed to contact the patient at a position remote from the first electrode 48. In the illustrated example, the second electrode 49 is disposable (e.g., adhesively attachable) to the patient's skin 5. However, the second electrode 49 may protrude from the handle 11 or may be provided on the cannula 53 in an electrically insulated state spaced apart from the first electrode 48.

[0183] The impedance sensor system 47 of FIG. 17 operates in the same manner as described above with reference to FIG. 16.

[0184] In some examples, the cannula 53 shown in FIG. 17 may be a needle having a beveled tip.

[0185] FIG. 18 shows another example of a delivery device 10 (delivery system) including an impedance sensor system 47. This example is based on the delivery device 10 described above with reference to FIGS. 13A - 13C, and the delivery device 10 has a delivery sheath including a first portion 61 and a second portion 62 fixed to each other. The first portion 61 holds the housing portion 2 of the medical implant 1, and the second portion 62 holds the electrode lead wire 3. The diameter of the first portion 61 is larger than the diameter of the second portion 62. It will be understood that the impedance sensor system 47 described below may be used in combination with the power supply system 37 described above with reference to FIGS. 13A - 13C, or the power supply system 37 may be omitted.

[0186] As shown in FIG. 18, the second portion 62 includes a first electrode 48 formed at or near (in the vicinity of) the tip 71 of the second portion 62. The first electrode 48 may be a separate component attached to the second portion 62, or the second portion 62 may include an electrically insulating coating having an opening that exposes a part of the second portion 62 to define the first electrode 48.

[0187] The impedance sensor system 47 also includes a second electrode 49 disposed to contact the patient at a position remote from the first electrode 48. In the illustrated example, the second electrode 49 can be disposed (e.g., adhesively) with respect to the skin 5 of the patient. However, the second electrode 49 may protrude from the handle 11 or may be provided on the first portion 61 or the second portion 62 in an electrically insulated state spaced apart from the first electrode 48.

[0188] The impedance sensor system 47 of FIG. 18 operates in the same manner as described above with reference to FIG. 16.

[0189] FIG. 19 shows another example of a delivery device 10 (delivery system) including the impedance sensor system 47. This example is based on the delivery device 10 described above with reference to FIGS. 14A and 14B, and the delivery device 10 includes a delivery sheath including a first needle 65 and a second needle 66 configured (arranged) to deliver the medical implant 1 in the reverse direction. It will be understood that the impedance sensor system 47 described below may be used in combination with the power supply system 37 described above with reference to FIGS. 14A and 14B, or the power supply system 37 may be omitted.

[0190] As shown in FIG. 19, the second needle 66 includes a first electrode 48 formed at or near (in the vicinity of) the tip 72 of the second needle 66. The first electrode 48 may be a separate component attached to the second needle 66, or the second needle 66 may include an electrically insulating coating having an opening that exposes a part of the second needle 66 to define the first electrode 48.

[0191] The impedance sensor system 47 also includes a second electrode 49 arranged to contact the patient at a position remote from the first electrode 48. In the illustrated example, the second electrode 49 is positionable (e.g., adhesively attachable) relative to the patient's skin 5. However, the second electrode 49 may project from the handle 11 or may be provided on the first needle 65 or the second needle 66 in an electrically insulated state spaced apart from the first electrode 48.

[0192] The impedance sensor system 47 of FIG. 19 operates in the same manner as described above with reference to FIG. 16.

[0193] In some examples, one or more electrodes 4 on the electrode lead wire 3 of the medical implant 1 may be used as one of the electrodes for detecting impedance. For example, the first electrode 4 on the electrode lead wire 3 may be the first electrode of the impedance sensor, and the second electrode 4 on the electrode lead wire 3 may be the second electrode of the impedance sensor. Alternatively, one electrode 4 (see FIG. 1) on the electrode lead wire 3 may be the first electrode of the impedance sensor, and the second electrode may be the second electrode 49 shown in FIGS. 16 - 19. Alternatively, one electrode 4 (see FIG. 1) on the electrode lead wire 3 may be the first electrode of the impedance sensor, and the second electrode may be formed on a delivery sheath (e.g., the second needle 13 as shown in FIG. 16, the cannula 53 as shown in FIG. 17, the second portion 62 as shown in FIG. 18, or the first needle 65 as shown in FIG. 19). In each example, the first electrode and the second electrode are spaced apart from each other and are used to detect impedance to detect the tissue boundary proximate to the electrode lead wire 3.

[0194] FIG. 20 schematically illustrates the operation of various delivery devices 10 for implanting the medical implant 1. The illustrated method is applicable to any of the medical implants 1 described herein and to any of the delivery devices 10 described herein. This method uses the delivery device 10 that holds the medical implant 1 as described above.

[0195] As shown in FIG. 20, this method comprises a step 78 of percutaneously placing the delivery sheath of the delivery device into the patient's tissue. The delivery sheath penetrates the skin and is inserted into the patient's subcutaneous tissue. An ultrasonic scanner may be used to visualize the position of the delivery sheath, whereby the operator can direct the delivery sheath towards the nerve.

[0196] This method further comprises a step 79 of detecting the electrical impedance between the tip of the delivery sheath and another location of the patient. The electrical impedance can be detected using the impedance sensor system 47 described above with reference to FIGS. 16-19. As described above, the detected electrical impedance can indicate how close the delivery sheath is to the boundary of the nerve tissue. Thus, the detected electrical impedance can be used by the operator to confirm how close the delivery sheath is to the nerve without damaging the nerve.

[0197] In some examples, the above method can be used to properly position the delivery sheath relative to the nerve and implant a medical implant. In examples such as the above, this method may comprise a step 84 of releasing the medical implant from the delivery device and withdrawing the delivery sheath from the patient.

[0198] Optionally, this method may comprise a step 80 of partially exposing the electrodes of the medical implant. This step may include retracting a portion of the delivery sheath or partially extruding the medical implant from the delivery sheath in various examples as described above.

[0199] This method may further comprise a step 81 of supplying power to the medical implant within the delivery device. In particular, as described in detail above, the power supply system of the delivery device can be operated to supply power to the medical implant within the delivery device.

[0200] This method may further comprise step 82 of evaluating the position of the electrode. In particular, when the medical implant includes a nerve stimulation implant, this method may further comprise a step of detecting the patient's response and evaluating the position of the electrode. Alternatively, when the medical implant is a diagnostic implant, this method may comprise step 82 of examining diagnostic measurements (readings) to evaluate the position of the electrode.

[0201] Based on the evaluated position of the electrode, this method may comprise step 83 of repositioning the delivery sheath and the electrode. When the electrode is repositioned, the position of the electrode is evaluated again (step 82), and this is repeated until the position of the electrode is within the acceptable range.

[0202] Finally, this method may comprise step 84 of implanting the medical implant and withdrawing the delivery sheath from the patient.

[0203] Throughout the description and claims of this specification, terms such as "comprise", "have", "include" are intended to be "comprise (have, include) 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.

[0204] Features, integer values, characteristics, or groups described in connection with a particular aspect, embodiment, or example of the present invention are to be understood as applicable to other aspects, embodiments, or examples described herein, unless 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, are combinable 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 or novel combination of features disclosed in this specification (including the appended claims, abstract, and drawings), or any novel or novel combination of steps of any methods or processes.

Claims

1. A delivery device for percutaneously implanting medical implants into a patient's tissue, A delivery sheath configured to at least partially surround the medical implant and to hold the medical implant for percutaneous delivery into the patient's tissue, The system comprises a power supply system configured to supply power to the medical implant within the delivery sheath, Delivery device.

2. The aforementioned medical implant is equipped with a power terminal, The power supply system includes electrical contacts arranged within the delivery sheath to form an electrical connection with the power terminal of the medical implant. The delivery device according to claim 1.

3. The aforementioned medical implant is equipped with a wireless power receiver, The power supply system includes a wireless power transmitter configured to wirelessly transmit power to the wireless power receiver of the medical implant. The delivery device according to claim 1.

4. The wireless power transmission transmitter is located within the delivery sheath. The delivery device according to claim 3.

5. The system further includes a guide section configured to restrain the position and orientation of the delivery sheath relative to the patient during use, The power supply system is provided within the guide section. The delivery device according to claim 3.

6. For example, it further includes a power source such as a battery, or a connector for an external power source such as a main power supply or an external battery, or a wireless power receiver for connecting to an external wireless power transmitter. A delivery device according to any one of claims 1 to 5.

7. The delivery device is equipped with a handle, The delivery sheath extends from the handle, A delivery device according to any one of claims 1 to 5.

8. At least a portion of the delivery sheath is retractable relative to the handle to partially expose the medical implant during percutaneous delivery into the patient's tissue. The delivery device according to claim 7.

9. At least a portion of the delivery sheath is retractable to release the medical implant within the patient's tissue. The delivery device according to claim 8.

10. The delivery sheath comprises a needle or cannula. The delivery device according to claim 7.

11. The aforementioned medical implant comprises a housing portion and an elongated electrode lead wire extending from the housing portion. The delivery sheath is configured to hold the housing portion for percutaneous delivery into the patient's tissue. A delivery device according to any one of claims 1 to 5.

12. The delivery sheath is also configured to hold the electrode lead wires for percutaneous delivery into the patient's tissue. The delivery device according to claim 11.

13. The delivery sheath is configured to hold the electrode lead wires for percutaneous delivery into the patient's tissue and includes a retractable portion. The delivery device according to claim 12.

14. The aforementioned medical implant is a nerve stimulation implant, The delivery device further comprises a sensor capable of detecting the patient's response when the power supply system supplies power to the nerve stimulation implant during transcutaneous delivery. A delivery device according to any one of claims 1 to 5.

15. The sensor is configured to detect the patient's movement response. The delivery device according to claim 14.

16. The sensor is configured to detect nerve signals. The delivery device according to claim 14.

17. The system further includes a graphical user interface capable of displaying information received from the aforementioned sensor. The delivery device according to claim 14.

18. A medical implant for embedding in the patient's tissue, Wireless power receiver and The medical implant comprises a power terminal for forming an electrical connection with the electrical connector of the delivery device during implantation of the medical implant, Medical implants.

19. It also features a housing section, The power terminals are located in the housing portion. A medical implant according to claim 18.

20. The housing portion further comprises elongated electrode lead wires, The electrode lead wire is equipped with an electrode. A medical implant according to claim 19.

21. A medical implant for embedding in the patient's tissue, A first wireless power receiver for wirelessly coupling with an external wireless power transmitter when implanted in the patient's tissue, The system comprises a second wireless power receiver for wirelessly coupling a wireless power transmitter of a delivery device with a wireless power transmitter during the implantation of the medical implant, Medical implants.

22. A medical implant for embedding in the patient's tissue, The device includes a selectively adjustable wireless power receiver that receives wireless power transmission from an external wireless power transmitter when implanted in the patient's tissue, and receives wireless power transmission from a wireless power transmitter of the delivery device during the implantation of the medical implant. Medical implants.

23. The aforementioned medical implant is either a nerve stimulation implant or a diagnostic implant. A medical implant according to any one of claims 18 to 22.

24. A method of percutaneously implanting medical implants into the patient's tissue, The steps include preparing a delivery device having a power supply system and a delivery sheath for holding the medical implant, The steps include: percutaneously placing the delivery sheath within the patient's tissue; The procedure includes the step of inspecting the position of the medical implant by supplying power to the medical implant in the delivery sheath using the power supply system of the delivery device, method.

25. The method further includes the step of exposing the electrodes of the medical implant while inspecting the position of the medical implant. The method according to claim 24.

26. The further step involves repositioning the delivery sheath based on feedback obtained from the examination of the position of the medical implant. The method according to claim 24 or claim 25.

27. The aforementioned medical implant consists of a nerve stimulation implant. The method further comprises the step of detecting the patient's response while examining the position of the nerve stimulation implant. The method according to claim 24 or 25.

28. The step of detecting the patient's response includes detecting the patient's movement response. The method according to claim 27.

29. The step of detecting the patient's response includes detecting the patient's nerve signals. The method according to claim 27.

30. The system further includes the step of displaying information received from a sensor on a graphical user interface. The method according to claim 27.

31. The further step includes displaying information regarding the operation of the medical implant on a graphical user interface. The method according to claim 27.

32. A delivery device for percutaneously implanting medical implants into a patient's tissue, A delivery sheath configured to at least partially surround the medical implant and to hold the medical implant for percutaneous delivery to the patient's tissue, An impedance sensor having a first electrode and a second electrode positioned to contact the patient at mutually separated positions, The impedance sensor is operable to detect the electrical impedance between the first electrode and the second electrode in order to detect changes in the tissue in the delivery sheath during the percutaneous delivery of the medical implant. Delivery device.

33. The first electrode and / or the second electrode are arranged in the delivery sheath, for example, at or near the tip of the delivery sheath. The delivery device according to claim 32.

34. The first electrode and / or the second electrode are provided on the medical implant. A delivery device according to claim 32 or claim 33.

35. The second electrode can be positioned in the vicinity of the transcutaneous delivery site on the patient's skin. The delivery device according to claim 32 or 33.

36. It further comprises an impedance analyzer configured to analyze the detected electrical impedance, The delivery device according to claim 32 or 33.

37. The impedance analyzer is configured to compare the detected electrical impedance with a threshold value. The delivery device according to claim 36.

38. The system further includes a graphical user interface for displaying information received from the impedance analyzer. The delivery device according to claim 36.

39. The system further comprises a power supply system configured to supply power to the medical implant within the delivery sheath. The delivery device according to claim 32 or 33.

40. A method of percutaneously implanting medical implants into the patient's tissue, The steps include percutaneously positioning a delivery sheath of a delivery device that holds the aforementioned medical implant, The steps include detecting the electrical impedance between a first electrode and a second electrode that are in contact with the patient at positions spaced apart from each other, The method comprises the step of analyzing the detected electrical impedance to detect tissue changes in the delivery sheath during percutaneous delivery of the medical implant, method.

41. The method further comprises the step of comparing the detected electrical impedance with a threshold value. The method according to claim 40.

42. The further step includes displaying the detected electrical impedance information on a graphical user interface. The method according to claim 40 or claim 41.

43. The procedure further comprises the step of supplying power to the medical implant within the delivery sheath in order to inspect the position of the medical implant before completely releasing it from the delivery sheath. The method according to claim 40 or 41.

44. A method for percutaneously delivering nerve stimulation implants to a patient's tissue, The steps include percutaneously positioning a delivery sheath that holds the nerve stimulation implant, A step of detecting a change in electrical impedance between a first electrode and a second electrode that are in contact with the patient at positions spaced apart from each other, which indicates a change in electrical impedance in the patient's tissue in the delivery sheath, The method comprises the step of supplying power to the nerve stimulator implant within the delivery sheath in order to examine the relative position of the nerve stimulator implant with respect to the patient's nerve, method.

45. The steps include positioning the delivery sheath near the nerve based on the detected electrical impedance, The procedure further comprises the step of checking the relative position of the nerve stimulator implant with respect to the nerve by supplying power to the nerve stimulator implant within the delivery sheath, The method according to claim 44.

46. The method further comprises the step of partially retracting the delivery sheath so as to expose the electrodes of the nerve stimulating implant before power is supplied to the nerve stimulating implant within the delivery sheath. The method according to claim 44 or claim 45.

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