Delivery devices and methods for percutaneous implantation of medical implants

Abstract

A delivery device (10) for percutaneous implantation of a medical implant (1) into tissue of a patient is provided. The delivery device comprises a delivery sheath (12, 13, 53, 61, 62, 65, 66) adapted to at least partially surround the medical implant and carry the medical implant for percutaneous delivery into the patient tissue. The delivery device further comprises a power delivery system (37) adapted to provide electrical power to the medical implant within the delivery sheath.

Description

[0001] The present invention relates to a delivery device and method for percutaneously implanting a medical implant, such as a neuromodulation implant, into tissue of a patient, a medical implant, and a method of percutaneously implanting a medical implant. background

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

[0003] According to a first aspect of the present disclosure, there is provided a delivery device for percutaneously implanting a medical implant into a patient's tissue, the delivery device comprising: a delivery sheath adapted to at least partially surround the medical implant and carry the medical implant for percutaneous delivery in a patient's tissue, and A power delivery system adapted to provide electrical power to a medical implant within a delivery sheath.

[0004] The power delivery system advantageously allows the medical implant to be powered during implantation to test the position of the medical implant before the medical implant is fully deployed.

[0005] In an example, the medical implant may include a power terminal. In such an example, the power delivery system may include an electrical contact disposed in the delivery sheath for forming an electrical connection with the power terminal of the medical implant.

[0006] In an example, the medical implant may include a wireless power receiver. In such an example, the power delivery system may include a wireless power transmitter arranged to transmit wireless power to the wireless power receiver of the medical implant. The wireless power transmitter may be disposed in a delivery sheath.

[0007] In an example, the delivery device may further include a guide adapted to constrain the position and orientation of the delivery sheath relative to the patient during use, and wherein the power delivery system is disposed in the guide. The guide may be removable from the delivery sheath. The guide may be against or attached to the patient. The guide may include a guide channel through which the delivery sheath passes and which constrains the position and orientation of the delivery sheath. The guide may be configured to target a specific target location within the patient's tissue, such as a target nerve. The guide, in particular the guide channel and / or a portion of the guide that engages the patient may be adjustable to allow adjustment of the position and orientation of the delivery sheath.

[0008] In an example, the delivery device may also include a power source, such as a battery. In other examples, the delivery device may also include a connector for an external power source, such as mains power or an external battery. In other examples, the delivery device may also include a wireless power receiver for coupling with an external wireless power transmitter. The external wireless power transmitter may be a device used with the medical implant after implantation, such as a wearable device.

[0009] In an example, the delivery device may include a handle, and the delivery sheath extends from the handle. In some examples, at least a portion of the delivery sheath may be retractable relative to the handle to partially expose the medical implant during percutaneous delivery in the patient's tissue. In an example, at least a portion of the delivery sheath may be retractable to release the medical implant in the patient's tissue. In an example, the delivery sheath may include a needle or a cannula.

[0010] In an example, a medical implant may include a housing portion and an elongated electrode lead extending from the housing portion. A delivery sheath may be adapted to carry the housing portion for percutaneous delivery in patient tissue. In an example, the delivery sheath may also be adapted to carry the elongated electrode lead for percutaneous delivery in patient tissue. In an example, the delivery sheath may include a retractable portion adapted to carry the elongated electrode lead for percutaneous delivery in patient tissue.

[0011] In an example, the medical implant is a neurostimulator implant. In such an example, the delivery device may also include a sensor operable to detect a patient's response when the power delivery system provides power to the neurostimulator implant during percutaneous delivery. In particular, the medical implant may include one or more electrodes operable to stimulate a patient's nerves, and the sensor may detect the patient's response to such stimulation. In an example, the sensor may be configured to detect a motor response of the patient. In an example, the sensor is configured to detect a neural signal.

[0012] In an example, the delivery device may also include a graphical user interface (GUI) operable to display information received from the sensor. The GUI may also display operating characteristics of the medical (neurostimulator) implant, such as operating frequency or amplitude. The GUI may also provide user input for controlling the delivery device (e.g., power delivery system).

[0013] According to a second aspect of the present disclosure, there is also provided a medical implant for implantation into a patient's tissue, the neurostimulator implant comprising: a wireless power receiver, and A power terminal is used to establish an electrical connection with an electrical connector of a delivery device during implantation of the medical implant.

[0014] Advantageously, the power terminals allow the medical implant to be powered in the delivery device during implantation, so the implantation site of the medical implant can be tested before the medical implant is fully deployed. This direct powering via the power terminals can be more reliable and efficient than using a wireless power receiver to power the medical implant while it remains in the delivery device.

[0015] In an example, the medical implant may further include a housing portion, and a power terminal may be provided on the housing portion. The power terminal may be located at one end of the housing portion. The power terminal may be located on one side of the housing portion, for example, the power terminal may be an annular electrode extending circumferentially around the housing portion. The housing portion may additionally house electronic components of the medical implant, including a wireless power receiver. In an example, when the medical implant has been implanted, the power terminal on the housing portion may additionally be an electrode for stimulation and / or sensing. For example, the power terminal may further be configured as a bioimpedance sensor.

[0016] In an example, 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 stimulation electrode and / or a sensing electrode.

[0017] According to a third aspect of the present disclosure, there is also provided a medical implant for implantation into a patient's tissue, the medical implant comprising: a first wireless power receiver for wireless power coupling with an external wireless power transmitter when implanted in a patient, and A second wireless power receiver is used for wireless power coupling with the wireless power transmitter of the delivery device during implantation of the medical implant.

[0018] In an example, a medical implant for implantation in patient tissue is also provided, the medical implant comprising a wireless power receiver capable of selectively tuning to receive wireless power transmission from an external wireless power transmitter when implanted in the patient, and to receive wireless power transmission from a wireless power transmitter of a delivery device during implantation of the medical implant.

[0019] In an example, the medical implant may be a neurostimulator implant operable to stimulate a nerve or target tissue of a patient. In other examples, the medical implant may be a diagnostic implant, particularly a diagnostic implant operable to detect neural signals. In other examples, the diagnostic implant may detect one or more patient vital signs, such as body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentration (e.g., oxygen, carbon dioxide, carbon monoxide).

[0020] According to a fourth aspect of the present disclosure, there is also provided a method for percutaneously implanting a medical implant into a patient's tissue, the method comprising: providing a delivery device having a power delivery system and a delivery sheath carrying a medical implant, percutaneously positioning the delivery sheath within the patient's tissue, and The position of the medical implant is tested by supplying power to the medical implant within the delivery sheath via a power delivery system of the delivery device.

[0021] Advantageously, the medical implant may thereby be powered during implantation to test the position of the medical implant prior to fully deploying the medical implant.

[0022] In an example, the method may further include exposing electrodes of the medical implant while testing the position of the medical implant.

[0023] In an example, the method may further include repositioning the delivery sheath based on feedback from the position of the test medical implant. The feedback may be provided by the patient (e.g., pain or tingling sensation), or by visual feedback from an operator (e.g., movement or other change), or by a sensor.

[0024] In an example, the method may include using a guide to constrain the position and orientation of the delivery sheath relative to the patient while percutaneously positioning the delivery sheath in the patient's tissue.

[0025] In an example, the medical implant may include a neurostimulator implant. In such an example, the method may further include detecting a patient's response when testing the position of the neurostimulator implant. In an example, detecting the patient's response may include detecting a motor response of the patient. In an example, detecting the patient's response may include detecting a neural signal of the patient.

[0026] In an example, the method may further include displaying information received from the sensor on a graphical user interface. In an example, the method may further include displaying information about the operation of the medical implant on the graphical user interface. For example, the method may include displaying an operating characteristic of the medical implant.

[0027] In an example, a medical implant may include a housing portion and an elongated electrode lead, the elongated electrode lead including an electrode. The method may include implanting the housing portion at a first depth in the patient's tissue, and implanting the electrode lead at a second depth in the patient's tissue. The second depth may be greater than the first depth. In an example, the method may include implanting the electrode lead at different angles relative to the housing portion. In an example, the housing portion includes a wireless power receiver and is implanted so that the wireless power receiver is oriented toward a skin surface of the patient (e.g., the housing portion is substantially parallel to the skin surface). In an example, the electrode lead may be implanted in a nonlinear arrangement, such as where a first element is substantially parallel to the housing portion and a second element is angled relative to the housing portion and extends toward a nerve of the patient.

[0028] According to a fifth aspect of the present disclosure, there is also provided a delivery device for percutaneously implanting a medical implant into a patient's tissue, the delivery device comprising: a delivery sheath adapted to at least partially surround the medical implant and carry the medical implant for percutaneous delivery in a patient's tissue, and an impedance sensor comprising a first electrode and a second electrode, the first electrode and the second electrode being arranged at spaced-apart positions, Therein, the impedance sensor is operable to detect electrical impedance between the first electrode and the second electrode to detect changes in tissue at the delivery sheath during percutaneous delivery of the medical implant.

[0029] Advantageously, the detected electrical impedance can inform the operator when the delivery sheath approaches or enters a different tissue type. This can aid in positioning the delivery sheath and medical implant during implantation.

[0030] In an example, the first electrode and / or the second electrode can be disposed on a delivery sheath, for example at or near the top of the delivery sheath. In other examples, the first electrode and / or the second electrode can be on a medical implant. The first and / or the second electrode can be a sensing or stimulation electrode of the medical implant. In some examples, the medical implant includes a housing portion and an electrode lead extending from the housing portion, and the first and / or the second electrode can be formed on the housing portion or on the electrode lead. In some examples, the second electrode can be positioned against the patient's skin (e.g., adhered or tied to the skin) near the transcutaneous delivery site.

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

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

[0033] In an example, the delivery device may further comprise a power delivery system adapted to provide electrical power to the medical implant within the delivery sheath.The power delivery system may comprise any of the features described above with respect to the first to fourth aspects of the present disclosure.

[0034] According to a sixth aspect of the present disclosure, there is also provided a method for percutaneously implanting a medical implant into a patient's tissue, the method comprising: A delivery sheath for a percutaneously positioned delivery device carrying a medical implant, detecting electrical impedance between a first electrode and a second electrode, the first electrode and the second electrode being in contact with the patient at spaced-apart locations, and The detected electrical impedance is analyzed to detect changes in tissue at the delivery sheath during percutaneous delivery of the medical implant.

[0035] Advantageously, the detected electrical impedance can inform the operator when the delivery sheath approaches or enters a different tissue type. This can aid in positioning the delivery sheath and medical implant during implantation.

[0036] In an example, the method may further include comparing the detected electrical impedance to a threshold value. In an example, the method may include comparing the detected electrical impedance to a database or other comparable data, for example to determine tissue type or anatomical features. In an example, the database or comparable data may be provided in a distributed location, and the impedance analyzer may communicate via a wireless communication channel.

[0037] In an example, the method may further include displaying information related to the detected electrical impedance on a graphical user interface.

[0038] In an example, the method may further include powering the medical implant within the delivery sheath to test the position of the medical implant before fully releasing the medical implant from the delivery sheath.The method may further include any of the features described above with respect to the first to fourth aspects of the present disclosure.

[0039] According to a seventh aspect of the present disclosure, there is also provided a method for percutaneously delivering a neurostimulator implant into a patient's tissue, the method comprising: percutaneously positioning a delivery sheath carrying the neurostimulator implant; detecting a change in electrical impedance between a first electrode and a second electrode in contact with the patient at spaced-apart locations, the change in electrical impedance indicative of a change in patient tissue at the delivery sheath; and Power is supplied to the neurostimulator implant within the delivery sheath to test the position of the neurostimulator implant relative to the patient's nerve.

[0040] In an example, the method may further include positioning the delivery sheath proximate to the nerve based on the detected electrical impedance, and then testing the position of the neurostimulator implant relative to the nerve by powering the neurostimulator implant within the delivery sheath.

[0041] Advantageously, the detected electrical impedance change can notify the operator that the delivery sheath is proximate to a nerve or other target anatomical site, while simultaneously powering the neurostimulator implant within the delivery device allows the operator to test the implant site prior to fully deploying the neurostimulator implant. Thus, implant placement can be improved, and any difficult or disruptive removal or repositioning of the neurostimulator implant can be avoided.

[0042] In an example, the method may further include partially retracting the delivery sheath to expose electrodes of the neurostimulator implant prior to powering the neurostimulator implant within the delivery sheath.

[0043] According to another aspect of the present invention, a delivery device for percutaneously implanting a medical implant into a patient's tissue is provided. The delivery device comprises a delivery sheath adapted for percutaneous positioning and having an inner cavity adapted for carrying the medical implant for percutaneous implantation.

[0044] In an example, the delivery sheath includes a cannula or needle for percutaneous implantation of a medical implant. The cannula or needle can be positioned percutaneously, and the medical implant can be ejected from the cannula or needle, for example, by a pusher. The needle can include a sharp tip, such as a beveled tip. The needle or cannula can be adapted to pierce the patient's skin and / or can be inserted through an incision in the patient's skin.

[0045] In an example, a delivery sheath may include a first portion and a second portion, the first portion holding a first element of a medical implant (e.g., a housing portion), the second portion protruding from the first portion for holding a second element of the medical implant (e.g., an electrode lead). The first portion and the second portion may be fixed to each other and have different diameters (e.g., the second portion may have a smaller diameter than the first portion). The second portion may include a groove extending from the first portion to its top along its length. The first portion may also have a groove or opening in a side that is aligned with the groove of the second portion. In this way, the medical implant may be deployed by pushing the medical implant out of the first portion and the second portion by a pusher. For example, the housing portion may be pushed out of the first portion via the groove or opening, and then the delivery device may be retracted to fully implant the medical implant.

[0046] In an example, a medical implant may include a housing portion (e.g., housing electronic devices of the medical implant, such as a wireless power receiver) and an elongated electrode lead extending from the housing portion. In an example, a delivery sheath may include a first needle or cannula adapted to hold the medical implant such that the electrode lead is directed away from the tip of the needle. A second needle may hold the electrode lead within the first needle or cannula and may extend beyond the tip of the first needle or cannula to implant the electrode lead.

[0047] In an example, the delivery device may further include a power delivery system for powering a medical implant within the delivery device.

[0048] In an example, the delivery device may further include an impedance sensor system to detect changes in tissue at the delivery sheath during percutaneous delivery of the medical implant.

[0049] In an example, the delivery device may further include other features of the delivery device described above with reference to the first to seventh aspects of the present disclosure.

[0050] According to another aspect of the present invention, a medical implant is provided, which includes a wireless power receiver adapted to wirelessly couple with an external device to receive wireless power, and a wireless power transmitter adapted to wirelessly couple with another medical implant to transmit wireless power to the other medical implant.

[0051] The medical implant may include a first portion holding a wireless power receiver and a second portion holding the wireless power transmitter. The second portion may be implanted at a greater depth (relative to the skin) than the first portion. The medical implant may thereby act as a power repeater for improving wireless power transmission to the other medical implant. In an example, the other medical implant may be a deep tissue medical implant, such as a neurostimulator implant, or a diagnostic implant, or a pacemaker implant, etc. BRIEF DESCRIPTION OF THE DRAWINGS

[0052] Embodiments of the present invention are further described below with reference to the accompanying drawings, in which: Figure 1 An example medical implant is shown; Figure 2 The location of a medical implant within a patient's body, particularly in a subcutaneous location, is shown; FIG. 3A to FIG. 3E Alternative example medical implants are shown; Figure 4A and Figure 4B An alternative medical implant for relaying wireless power to another medical implant is shown; FIG. 5A to FIG. 5F A different delivery device having a first needle and a second needle and a power delivery system is shown; FIG. 6A to FIG. 6C Operation of an example delivery device having a first needle and a second needle is shown; Figure 7 Shows FIG. 5A to FIG. 6C a first needle and a second needle of a delivery device; Fig. 8A Shows FIG. 5A to FIG. 6C a second needle of a delivery device; Figure 8B Shows FIG. 5A to FIG. 6C a first needle of a delivery device; Fig. 9 An alternative delivery device is shown with the second needle in an initial retracted position; Fig.10 An alternative conveyor arrangement with a rack and pinion drive arrangement is shown; FIG. 11A to FIG. 11C An alternative delivery device is shown having a rack and pinion arrangement and wherein the electrode lead extends from an end of the housing portion facing the handle; FIG. 12A to FIG. 12D An example delivery device having a cannula and a power delivery system is shown; FIG. 13A to FIG. 13C An example delivery device having a delivery sheath and a power delivery system is shown, the delivery sheath having a first portion and a second portion; Fig.14A and Fig. 14B An example delivery device operable to deliver a medical implant in a reverse orientation and having a power delivery system is shown; Fig.15 Operation of a delivery device to test the position of a medical implant during implantation is shown; Fig.16 An example delivery device having a first needle and a second needle and an impedance sensor system is shown; Fig.17An example delivery device having a cannula and an impedance sensor system is shown; Fig.18 An example delivery device having a delivery sheath and an impedance sensor system is shown, the delivery sheath having a first portion and a second portion; Fig.19 An example delivery device operable to deliver a medical implant in a reverse orientation and having an impedance sensor system is shown; and Fig. 20 A method of implanting a medical implant is schematically shown. Detailed Description

[0053] Figure 1 A medical implant 1 is schematically shown. In an example, the medical implant 1 can be a neurostimulator implant or a diagnostic implant. The medical implant 1 includes a housing portion 2 and an elongated electrode lead 3. The housing portion 2 can house electronic device components of the medical implant 1, including, for example, a printed circuit board, a wireless communication receiver / transmitter, a wireless power receiver and / or sensor electronics, as further described below. In an example, the housing portion is hermetically sealed. The housing portion 2 can include a cylindrical housing with sealed ends, or can include a wrap or other enclosure of components within the housing portion 2.

[0054] In examples, the electrode lead 3 extends from the housing portion 2 and is flexible. The electrode lead 3 includes at least one electrode 4, and in some examples, a plurality of electrodes 4 spaced along the length of the electrode lead 3. The electrode 4 is connected to electronics within the housing portion 2.

[0055] In an example, the housing portion 2 may have a diameter between about 0.5 mm and about 5 mm, such as a diameter between about 1 mm and about 3 mm. The housing portion 2 may have a length of at most about 30 mm, such as at most about 20 mm, such as at most about 10 mm, such as at most about 5 mm. In an example, the electrode lead 3 may have a diameter between about 0.3 mm and about 1.5 mm, such as a diameter between about 0.5 mm and 1.3 mm. The electrode lead 3 may have a length of at most about 200 mm, such as at most about 150 mm, such as at most about 100 mm, such as at most about 50 mm, such as about 50 mm. In an example, the electrode lead 3 may have a length between about 100 mm and about 200 mm. However, it will be appreciated that the size of the housing portion 2 will correspond to the size of the electronic device to be placed in the housing portion 2, and the length of the electrode lead 3 will correspond to the anatomical structure around the target nerve, so a shorter or longer electrode lead 3 may be appropriate depending on the depth of the nerve in the muscle tissue.

[0056] As further described below, the medical implant 1 can be implanted in a patient and can be operated to sense and / or stimulate nerves or patient tissue. In some examples, the medical implant 1 can be implanted to sense and / or stimulate the hypoglossal nerve, in particular the medial branch and / or distal branch of the hypoglossal nerve. In one example, the medical implant 1 can be implanted in a patient and can be operated to sense and / or stimulate the genioglossal nerve branches within the genioglossus muscle. In some examples, the medical implant 1 can be implanted to sense and / or stimulate the cervical loop nerve. Stimulating the hypoglossal nerve (genioglossal nerve branches) and / or the cervical loop nerve can provide treatment for sleep apnea. In other examples, the medical implant 1 is implantable to sense and / or stimulate the greater occipital nerve, but the same or similar implant can be implantable to sense and / or stimulate other nerves, in particular other peripheral nerves of the peripheral nervous system. In an example, the medical implant 1 can be implantable to sense and / or stimulate the tibial nerve, the sacral nerve (e.g., for treating urinary incontinence) or the vagus nerve (e.g., for regulating pancreatic secretion).

[0057] Figure 2 The medical implant 1 is shown when implanted in a patient. The medical implant 1 is positioned below the surface of the skin, in particular below the epidermis 5. The housing portion 2 may be positioned in the dermis 6 or in the subcutaneous tissue 7. Positioning the housing portion 2 in the subcutaneous tissue 7 may be advantageous in causing less trauma and / or irritation to the patient, and may also improve wireless power transmission between an external device and the medical implant.

[0058] As shown, the electrode lead 3 extends from the housing portion 2, passes through the underlying tissue (particularly muscle 8), and reaches a position close to the target nerve 9. The electrode lead 3 is positioned so that the electrode (4, see Figure 1 ) is in contact with or close to the nerve 9, and thus the electrode 4 can be used to sense and / or stimulate the nerve 9. In an example, the electrode lead 3 can be implanted so that it is approximately parallel to the nerve 9 at least in the area with the electrode 4.

[0059] The medical implant 1 may further comprise one or more anti-migration members. The anti-migration members may be provided on the housing portion 2 and / or on the electrode lead 3 and are used to maintain the medical implant 1 in place in the patient's tissue.

[0060] In an example, the medical implant 2 is battery-free and does not have an integrated power source. The external device 32 can wirelessly power the medical implant 1. The external device 32 can also wirelessly communicate with the medical implant 1, in particular the electronic devices in the housing portion 2. The medical implant 1 can include a wireless communication receiver / transmitter for communicating with the external device 32. The medical implant 1 can also have a processor or controller configured to operate the medical implant 1. The external device 32 can be positioned on the skin near the medical implant 1. The external device 32 can be adhered to the skin near the medical implant 1. The external device 32 can be a wearable device.

[0061] In an example, the medical implant 1 is a neurostimulator implant.The medical implant 1 may be implanted to target a specific nerve or group of nerves, such as the hypoglossal nerve (distal and / or medial branches, eg genioglossal nerve branches) or the greater occipital nerve.

[0062] In operation, the electrodes 4 of the neurostimulator implant are provided with an electrical signal, such as an electric current, to stimulate the nerve or target tissue. In an example, the electrical signal may be a voltage-regulated stimulation. Such stimulation may provide relief for various conditions, such as sleep disorders (hypoglossal and / or cervical nerves), and / or chronic pain, such as occipital neuralgia, refractory migraine, and / or other therapeutic benefits.

[0063] In other examples, the medical implant 1 can be a diagnostic implant, such as a neurodiagnostic implant, which is operable to detect one or more neural signals in a nerve. In such an example, the electrode 4 is operable to detect the neural signal. The neural signal can be analyzed for the purpose of detecting, monitoring and / or diagnosing a condition.

[0064] In other examples, the medical implant 1 may be a diagnostic implant operable to detect one or more patient vital signs, such as body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentrations (e.g., oxygen, carbon dioxide, carbon monoxide).

[0065] FIG. 3A to FIG. 3E Alternative examples of medical implants 1 are shown. In each example, the medical implant 1 has a housing part 2 and one or more electrodes 4. FIG. 3A to FIG. 3D In the example of FIG. 1 , the medical implant 1 includes an electrode lead 3 and an electrode 4 formed on the electrode lead 3. Figure 3E In the example of FIG. 4 , the medical implant 1 does not include the electrode lead 3 , and the electrode 4 is formed on the housing part 2 . Figure 3E Examples of may be a neurostimulator implant or a diagnostic implant implantable near a nerve in the same manner as described above.

[0066] exist FIG. 3A to FIG. 3EIn the example of FIG. 1 , the housing portion 2 includes a housing 2a. The housing 2a may be cylindrical and houses electronic components therein. The housing 2a is preferably ceramic, such as zirconium oxide. The housing portion 2 includes a wireless power receiver 35, 35b for receiving power from an external device (32, see FIG. 1 ) when implanted in a patient. Figure 2 ) receives wireless power. In an example, the wireless power receiver 35, 35b can also be used to communicate with an external device (32, see Figure 2 ) for wireless data communication. FIG. 3A to FIG. 3D In the example of FIG. 1 , the medical implant 1 further comprises an electrode lead 3 extending from the housing portion 2 , and the electrode 4 may be disposed on the electrode lead 3 .

[0067] like Figure 3A As shown, the housing portion 2 includes a first power terminal 33a and a second power terminal 33b formed on the housing 2a of the housing portion 2. In particular, the first power terminal 33a and the second power terminal 33b are conductive areas of the housing 2a and are separated by an insulating portion 34. The first power terminal 33a and the second power terminal 33b can be point contacts. Alternatively, the first power terminal 33a and the second power terminal 33b can be conductive areas of the housing 2a and thus extend over a portion of the length of the housing 2a. As further described below, the first power terminal 33a and the second power terminal 33b can be connected to a power delivery system within the delivery device to power the medical implant 1 within the delivery device during implantation. The wireless power receiver 35 is disposed in the housing portion 2 and can be spaced apart from the first power terminal 33a and the second power terminal 33b.

[0068] exist Figure 3B In the example of , the housing portion 2 includes a first power terminal 36a and a second power terminal 36b formed at one end of the housing portion 2, in particular at an end of the housing 2a opposite to the electrode lead 3. As further described below, the first power terminal 36a and the second power terminal 36b can be connected to a power delivery system within the delivery device to power the medical implant 1 within the delivery device during implantation. The wireless power receiver 35 is disposed in the housing portion 2 and can be spaced apart from the first power terminal 33a and the second power terminal 33b.

[0069] exist Figure 3C In the example of FIG. 1 , the housing portion 2 includes a first wireless power receiver 35a and a second wireless power receiver 35b. As further described below, the first wireless power receiver 35a is arranged to receive wireless power when the medical implant 1 is in the delivery device during implantation. The second wireless power receiver 35b is arranged to receive wireless power from an external device (32, see FIG. 1 ) once the medical implant 1 has been implanted in the patient. Figure 2) receives wireless power. In this example, as shown in the figure, the housing portion 2 optionally also includes a similar Figure 3B The first power terminal 36a and the second power terminal 36b of those described above. In another example, the housing portion 2 may include a first power terminal 36a and a second power terminal 36b similar to those described above. Figure 3A and Figure 3D The first power terminal 33a and the second power terminal 33b of those described.

[0070] In another example, the medical implant 1 may include a single wireless power receiver 35 that can receive wireless power from a wireless power transmitter of a delivery device during implantation (described further below) and from an external device (32, see Figure 2 ) to receive wireless power. In this example, the wireless power receiver 35 may be configurable, e.g., tunable, to operate at different frequencies for receiving power during and after implantation. Advantageously, this allows testing of the wireless power receiver 35 (and the medical implant 1) during implantation.

[0071] exist Figure 3D In the example of , the housing portion 2 includes a first power terminal 36a and a second power terminal 36b formed as ring electrodes on the housing 2a. As further described below, the first power terminal 33a and the second power terminal 33b can be connected to a power delivery system within the delivery device to power the medical implant 1 within the delivery device during implantation. The wireless power receiver 35 is disposed in the housing portion 2 and can be spaced apart from the first power terminal 33a and the second power terminal 33b.

[0072] In some examples, the housing portion 2 may include more than two annular electrodes 36a, 36b, for example four annular electrodes 36a-36d. Figure 3D As shown. After implantation of the medical implant 1, one or more of the ring electrodes 36a-36d can be used as a sensor, such as an impedance sensor. In some examples, the same ring electrodes 36a-36d can be used as power terminals for powering the medical implant 1 within the delivery device and as sensor electrodes after implantation. In some examples, at least two of the ring electrodes 36a-36d are made of different materials, in particular different metals, to allow differential impedance sensing.

[0073] exist Figure 3E In the example of the present invention, the medical implant 1 comprises a housing part 2 and has no FIG. 3A to FIG. 3DThe example of an electrode lead 3. In this example, the housing 2a of the housing portion 2 has a first power terminal 33a and a second power terminal 33b separated by an insulating portion 34 for connecting to a power delivery system of a delivery device during implantation. The housing 2a also includes electrodes 4 separated by other insulating regions 34. In some examples, as shown, the housing portion 2 also holds a wireless power receiver 35. The wireless power receiver 35 is disposed in the housing portion 2 and can be spaced apart from the first power terminal 33a and the second power terminal 33b and from the electrode 4.

[0074] exist FIG. 3A to FIG. 3E In the example of the medical implant 1, a plurality of electrodes 4 and power terminals 33a, 33b, 36a, 36b for connecting to a power delivery system of a delivery device during implantation. It will be appreciated that after implantation, the power terminals 33a, 33b, 36a, 36b can act as further electrodes 4 (i.e., they can be operated to sense neural signals and / or provide neural stimulation).

[0075] Figure 4A and Figure 4B An alternative medical implant 1 is shown for use in conjunction with another medical implant 73. The other medical implant 73 may be a deep tissue implant, such as a pacemaker. In these examples, the medical implant 1 may act as a wireless power receiver or wireless power repeater for the other medical implant 73. Figure 4A In the example of , the medical implant 1 can be connected to another medical implant 73 via a wire 74. The medical implant 1 includes a 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 lower depth in the tissue than the other medical implant 73, providing improved wireless power coupling due to the reduced distance to the external wireless power transmitter. Figure 4B In the example of , the medical implant includes a wireless power receiver 35 and a wireless power transmitter 75, and is arranged to relay power to a wireless power receiver 76 of another medical implant 73. The wireless power transmitter 75 of the medical implant 1 can be connected to the housing portion 2 by a wire 77, as shown, or it can be within the housing portion 2 and the wire 77 can be omitted. The medical implant 1 can be implanted at a lower depth in the tissue than the other medical implant 73, thereby providing improved wireless power coupling. Figure 4A and Figure 4B In the example of FIG. 1 , the medical implant 1 may include power terminals 33a, 33b, 36a, 36b and / or a wireless power receiver 35a (and reference FIG. 3A to FIG. 3E ), which allows the medical implant 1 to receive power within the delivery device during implantation, as further described below.

[0076] FIG. 5A to FIG. 5E Shows the FIG. 3A to FIG. 4B An example of a delivery device 10 for implanting a medical implant 1 into a patient's tissue is shown in FIG. In particular, the delivery device 10 is used to implant the medical implant 1 percutaneously into a Figure 2 Referring to an example medical implant 1 (particularly a neurostimulator implant) having a housing portion 2 and an electrode lead 3, FIG. 5A to FIG. 5E However, it will be appreciated that the delivery device 10 may be adapted to implant a reference FIG. 3A to FIG. 3E Other medical implants described 1.

[0077] exist FIG. 5A to FIG. 5E In the example of the delivery device 10, the delivery sheath includes a first element and a second element, specifically a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 are parallel and both extend in the longitudinal direction. The second needle 13 extends further than the first needle 12. In particular, the first needle 12 has a top 14, such as a beveled top, and the second needle 13 extends beyond the top 14 of the first needle 12. The second needle 13 also has a top 15, in particular a beveled top. The second needle 13 has a higher gauge than the first needle 12 (i.e., the second needle 13 has a smaller diameter than the first needle 12).

[0078] During use, the housing portion 2 of the medical implant 1 is received in the first needle 12, in particular in the lumen of the first needle 12. During use, the electrode lead 3 is received in the second needle 13, in particular in the lumen of the second needle 13. As shown, the electrode lead 3 extends along a majority of the second needle 13 toward the tip 15. A portion of the electrode lead 3 adjacent to the housing portion 2 extends through an opening in the second needle 13, as shown in FIG. Figure 7 Thus, during use, the medical implant 1 is positioned within the first needle 12 and the second needle 13 of the delivery device 10 .

[0079] As shown, the first needle 12 and the second needle 13 are axially offset. In particular, the center axis of the first needle 12 is offset from the center axis of the second needle 13. In the example shown, the second needle 13 extends into the first needle 12 (in particular, into the inner cavity of the first needle 12), so that the second needle 13 is partially received in the first needle 12, side by side with the housing part 2.

[0080] refer to Figure 7 , the second needle 13 includes an opening 18 or slot to allow a portion of the electrode lead 3 to extend out of the second needle 13 and connect to the housing portion 2. The opening 18 may extend to the top end 15 of the second needle 13. The opening 18 may extend along most of the second needle 13 or all of the second needle 13.

[0081] Reference again FIG. 5A to FIG. 5E During use, the first needle 12 percutaneously penetrates the patient's tissue to position the housing portion 2 at a first depth, and the second needle 13 percutaneously penetrates the patient's tissue to position the electrode lead 3 at a second depth. Once the electrode lead 3 is correctly positioned, the delivery device 10 releases and deploys the medical implant 1 to leave the medical implant 1 in the patient's body. Figure 2 The delivery device 10 is in the position shown. In some examples, the delivery device 10 can be rotated after the electrode lead 3 is implanted so that the housing portion 2 is implanted at a certain angle relative to the electrode lead 3. The delivery device 10 can be rotated when the first needle 12 is outside the patient (i.e., positioned percutaneously). The top 14 of the first needle 12 and the top 15 of the second needle 13 are sharp tops suitable for piercing the patient's skin and penetrating tissue to percutaneously position the first needle 12 and the second needle 13 at an appropriate depth. As known to those skilled in the art, the tops 14, 15 can be beveled tops. In some examples, during use, the first needle 12 and the second needle 13 are used to pierce the patient's skin and underlying tissue, and in some examples an incision is first formed and the first needle 12 and the second needle 13 are inserted into the patient's tissue through the incision.

[0082] In an example, the first needle 12 may have a gauge number between 6 and 15, such as 10. In an example, the second needle 13 may have a gauge number between 15 and 25, such as 20.

[0083] In various examples, the second needle 13 can be retracted relative to the first needle 12 to deploy the electrode lead 3. When the second needle 13 is retracted, the opening 18 (see FIG. 1 ) of the second needle 13 is Figure 7 ) allows deployment of electrode lead 3.

[0084] In an example, the housing portion 2 is releasably attached to the first needle 12 (or another portion of the delivery device 10 ) and is released prior to deployment.

[0085] In an example, the housing portion 2 may be simply deployed from the first needle 12 by pulling the implant delivery device away from the patient and relying on friction between the electrode lead 3 and the patient's tissue to hold the medical implant in place and pull the housing portion 2 from the first needle 12. In other examples, the delivery device 10 may include a deployment member, such as a pusher, adapted to push the housing portion 2 out of the first needle 12 to deploy the housing portion 2 at the appropriate anatomical site. In some examples, the implant delivery device may include a retaining member that is arranged to retain the housing portion 2 in the first needle 12 prior to deployment and may be operable to release the housing portion 2 prior to the delivery device 10 being removed.

[0086] like FIG. 5A to FIG. 5EAs shown, the delivery device 10 includes a power delivery system 37. The power delivery system 37 is arranged to provide power to the medical implant 1 within the delivery device 10, particularly when the housing portion 2 is received in the first needle 12 and the electrode lead 3 is received in the second needle 13. In this arrangement, the wireless power receiver (35, 35B, see FIG. 3A to FIG. 3E ) will not be reliably available from external devices (32, see Figure 2 ) receives wireless power, so the power delivery system 37 is provided in the delivery device 10 to power the medical implant 1 within the delivery device 10. Before the medical implant 1 is fully deployed from the delivery device 10, it may be advantageous to power the medical implant 1 within the delivery device 10 in order to test the position of the electrode 4 during implantation. In an example, in order to test the position of the electrode 4, the second needle 13 is partially retracted to expose the electrode 4, and the power delivery system 37 is operated to power the medical implant 1.

[0087] exist Figure 5A In the example, the conveying device 10 maintains Figure 3A The medical implant 1 is shown in which the first power terminal 33a and the second power terminal 33b are formed on the housing part 2. It will be appreciated that Fig.13A The conveying device 10 can also be used with Figure 3D . In this example, the power delivery system 37 includes a first connector 39a and a second connector 39b, which are arranged in the first pin 12 and are arranged to be connected to the first power terminal 33a and the second power terminal 33b on the housing part 2. A power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) is connected to the first connector 39a and the second connector 39b. Therefore, the medical implant 1 can be powered by the power source 38 when it is located within the delivery device 10. In the example, the first power terminal 33a and the second power terminal 33b are conductive areas of the housing 2a, which extend over a portion of the length of the housing 2a, and therefore the housing part 2 can move along the first pin 12 while maintaining contact with the first connector 39a and the second connector 39b on the first pin 12.

[0088] Alternatively, Figure 5A The delivery device 10 shown in FIG. 1 may be adapted to be implanted without the electrode lead 3. Figure 3E . In this example, the second needle 13 can be omitted, or only provided for piercing the patient's tissue. As described above, the first connector 39a and the second connector 39b of the power delivery system 37 are connected to the first power terminal 33a and the second power terminal 33b on the housing part 2 of the medical implant 1 to power the medical implant during implantation.

[0089] exist Figure 5B In the example, the conveying device 10 maintains Figure 3B The medical implant 1 shown, wherein the first power terminal 36a and the second power terminal 36b are formed at one end of the housing part 2. In this example, the power delivery system 37 includes a first connector 40a and a second connector 40b, which are arranged in the first pin 12 and are arranged to be connected to the first power terminal 36a and the second power terminal 36b on one end of the housing part 2. The first connector 40a and the second connector 40b of the power delivery system 37 can be arranged on a contact block 41 fixed in the first pin 12. A power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) is connected to the first connector 40a and the second connector 40b. Therefore, the medical implant 1 can be powered by the power source 38 when it is located in the delivery device 10.

[0090] In with Figure 5B In another similar example, the contact block 41 can be clamped onto the housing portion 2. The contact block 41 can be clamped onto the housing portion 2 to create an electrical connection, such as Figure 5B and is additionally used to retain the housing part 2 in the first needle 12. The contact block 41 can be released from the housing part 2 to allow the housing part 2 to be deployed during implantation.

[0091] exist Figure 5C In the example, the conveying device 10 maintains FIG. 3A to FIG. 3E In any of the examples shown in FIG. 1 , the medical implant includes a wireless power receiver 35. Figure 3C In a specific example of the medical implant 2, the medical implant 2 includes an additional wireless power receiver 35a. In this example, the power delivery system 37 includes a wireless power transmitter 42, which is arranged in the first needle 12, behind the housing part 2. A power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) is connected to the wireless power transmitter 42, and during operation, power is wirelessly transmitted to the wireless power receiver 35, 35a in the medical implant 1. Therefore, the medical implant 1 can be powered by the power source 38 when it is located in the delivery device 10.

[0092] In a similar Figure 5C In another example, the wireless power transmitter 42 can be clamped onto the housing portion 2. The wireless power transmitter 42 can be clamped onto the housing portion 2 to hold the housing portion 2 in the first needle 12 while also aligning the wireless power transmitter 42 to power the medical implant 1. The wireless power transmitter 42 can be released from the housing portion 2 to allow the housing portion 2 to be deployed during implantation.

[0093] Figure 5DShows something like Figure 5C In another example delivery device 10. In this example, the wireless power transmitter 42 is disposed in the second needle 13, adjacent to the housing portion 2 in the first needle 12. The wireless power transmitter 42 can be connected to the opening (18, see Figure 7 ) is aligned with the housing portion 2 to provide wireless power transmission to the housing portion 2. The wireless power transmitter 42 is preferably slidably received in the second needle 13. The wireless power transmitter 42 is preferably fixed relative to the handle 11. In this way, when the second needle 13 is retracted during implantation, the wireless power transmitter 42 does not move. The wireless power transmitter 42 may include an antenna formed by a coaxial cable, wherein the shielding is removed from one end to create a transmitting antenna aligned with the housing portion 2. The wireless power transmitter 42 is positioned adjacent to the wireless power receiver 35 / additional wireless power receiver 35a in the housing portion 2, thereby allowing the medical implant 1 to be powered when it is received in the delivery device 10, so that the medical implant 1 can be tested in situ before being deployed from the delivery device 10.

[0094] Figure 5E Another example delivery device 10 having a wireless power transmitter is shown. In this example, the wireless power transmitter includes a wireless power transmission antenna 43, which is positioned on the outside of the first needle 12, overlying the housing portion 2 within the first needle 12. The wireless power transmission antenna 43 is coupled to a power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) and is operable to transmit wireless power to the wireless power receiver 35 / additional wireless power receiver 35a in the housing portion 2. The first needle 12 may include an opening or (non-metallic) transmission window to facilitate wireless power transmission. Figure 5E As shown, the wireless power transmitting antenna 43 can slide over the first needle 12. In particular, the wireless power transmitting antenna 43 can slide from its shown position overlying the housing portion 2 to a retracted position toward the handle 11. In this way, the wireless power transmitting antenna 43 can be positioned to power the medical implant 1 when the electrode lead 3 is in place, and then retracted to allow the first needle 12 to be inserted into the patient's tissue. Figure 5E In some examples, the wireless power transmission antenna 43 can be detachable from the first needle 13. In these examples, instead of sliding the wireless power transmission antenna 43, the wireless power transmission antenna 43 can be a flexible or foldable sheet that can be attached to the first needle 12 to power the medical implant 1 and removed from the first needle 12 when powering the medical implant 1 is not needed.

[0095] Fig. 5FAnother example delivery device 10 is shown. In this example, the delivery device 10 includes a guide 90 adapted to constrain the position and orientation of the delivery sheath relative to the patient, in particular the position and orientation of the second needle 13 during insertion into the patient's tissue. As shown, the guide 90 includes a positioning portion 91 adapted to be shaped, for example, to be placed at a specific location on the patient and / or attached to a specific location on the patient. The specific location on the patient will depend on what the target implant site is, and can be any anatomical location, such as a bone, a joint, etc. The guide 90 also includes a guide channel 92, through which at least a portion of the delivery device 10 passes to constrain the position and orientation of the delivery sheath (the first needle 12 and the second needle 13) relative to the patient. The delivery sheath (the first needle 12 and the second needle 13) can slide along the guide channel 92 for inserting the second needle 13 and then the first needle 12 into the patient's body. In this example, the first needle 12 is constrained in the guide channel 92, but it will be appreciated that the second needle 13 may additionally or alternatively be constrained in the guide channel 92 or another portion of the delivery device 90, such as the handle 11. The guide 90 advantageously assists the operator in percutaneously positioning the electrode lead 4 at or proximal to the target implantation site, such as adjacent to a target nerve. The guide 90 may be separated from the delivery device 10 during implantation and may be removed after the electrode lead 3 has been implanted.

[0096] As shown, a power delivery system 37 is included in the guide 90, which is arranged to supply power to the medical implant 1 within the delivery device 10. In this example, the power delivery system 37 includes a power source 38 and a wireless power transmitter 42, which is positioned adjacent to the housing portion 1 of the medical implant 1 during use. In this way, as described above, the medical implant 1 can be powered within the delivery device 10 by the power delivery system 37 in the guide of the delivery device 10.

[0097] FIG. 6A to FIG. 6C Shows FIG. 5A to FIG. 5F The operation of the delivery device 10 of any one of the above.

[0098] As shown in the figure, the exemplary implant delivery device 10 further includes a handle 11. The handle 11 is suitable for being held by an operator. A first needle 12 is fixed to the handle 11.

[0099] The second needle 13 extends through the first needle 12 and through the handle 11. An actuation tab 16 is provided on the end of the second needle 13 opposite to the tip 15. In particular, the actuation tab 16 may be a gripping handle or the like for an operator to grip.

[0100] The second needle 13 can be retracted relative to the first needle 12. In particular, the second needle 13 can be retracted from Fig. 6A The location shown to Figure 6B The position shown is slid through the first needle 12 and the handle 11. In this example, the second needle 13 can be retracted by pulling the actuation tab 16 in a direction away from the patient. Retracting the second needle 13 in this manner deploys the electrode lead 3. Figure 7 ) is provided for the portion of the electrode lead 3 connected to the housing portion 2. The opening 18 extends to the top end 15 of the second needle 13.

[0101] A locking device 17 is provided to lock the second needle 13 to the handle 11 and / or the first needle 12. As shown, the locking device 17 can be arranged at or near the actuation tab 16 and in the example locks the actuation tab 16 and / or the second needle 13 to the handle 11. The locking device 17 locks the second needle 13 in Figure 6B in the extended position shown in .

[0102] exist Fig. 6A In the position shown, the operator can percutaneously position the implant delivery device 10 in the patient's tissue. The position of the second needle 13 is locked relative to the handle 11, so the operator can push the implant delivery device 10 into the patient's body through the handle 11. Fig. 6A and Figure 2 , when the implant delivery device 10 is pushed into the patient's body, the second needle 13 first penetrates the skin 5, and when the implant delivery device 10 is further pushed, the first needle 12 then penetrates the skin 5. The first needle 12 and the second needle 13 are thereby positioned at an appropriate depth in the patient's body, and the housing portion 2 and the electrode lead 3 are also positioned at an appropriate depth at the same time. Therefore, the implant delivery device 10 provides percutaneous delivery of the medical implant 1 into the patient's tissue. In an example, the operator can use an ultrasonic imaging device to monitor the position of the second needle 13 (and the first needle 12) to guide the second needle 13 to the target nerve 9. As further described below, the bioimpedance of the tissue at the electrode lead 3 can also be detected to assist in the positioning of the electrode lead 3.

[0103] In some examples, the delivery device 10 may include a guide, such as Fig. 5F The guide 90 shown in FIG. The guide can constrain the position and orientation of the second needle 13 and / or the first needle 12 during insertion.

[0104] When the implant delivery device 10 is in a proper position with the tip 15 of the second needle 13 (and the electrode lead 3 within the second needle 13) positioned near the nerve and the tip 14 of the first needle 12 (and the housing portion 2 within the first needle 12) positioned in the subcutaneous tissue, the second needle 13 can be partially retracted. Fig. 6A and Figure 6B In particular, the second needle 13 can be partially retracted to expose the electrode (4, see FIG. 3A to FIG. 3E ). In this position, the power delivery system (37, see FIG. 5A to FIG. 5E ) can power the medical implant 1 to test the electrodes (4, see FIG. 3A to FIG. 3E If necessary, the second needle 13 can be extended to Fig. 6A position as shown and reposition.

[0105] Once the electrode lead 3 is properly positioned, the second needle 13 is retracted. Figure 6B The electrode lead 3 is deployed in the position shown. In some examples, the electrode lead 3 may include one or more anti-migration features that are deployed when the second needle 13 is retracted to hold the electrode lead 3 in place.

[0106] The second needle 13 is retracted by unlocking the locking mechanism 17 and pulling the actuation tab 16 relative to the handle 11 to slide the second needle 13 to Figure 6B The retracted position shown. The actuation tab 16 is pulled in a direction away from the patient. During the retraction of the second needle 13, the handle 11 and the first needle 12 remain stationary. As shown, once the second needle 13 is retracted, the electrode lead 3 is deployed and exposed to the surrounding tissue (and nerves).

[0107] In some examples of using guides (see Fig. 5F ), the guide may be removed before or after the second needle 13 is retracted.

[0108] Next, if Figure 6C As shown, the implant delivery device 10 is withdrawn from the patient's body and the housing portion 2 is deployed from the first needle 12. In this example, the electrode lead 3 and tissue (see Figure 2 The friction between the muscles 8 in the patient's body and the electrode lead 3 is sufficient to hold the medical implant 1 in place when the implant delivery device 10 is withdrawn, thereby deploying the housing portion 2 out of the first needle 12 when the implant delivery device 10 is withdrawn from the patient's body. In some examples, the electrode lead 3 includes one or more anti-migration features, which are also used to hold the electrode lead 3 in place and pull the housing portion 2 out of the first needle 12.

[0109] In other examples, the implant delivery device 10 may include a deployment member (e.g., a pusher in the first needle 12) configured to push the housing portion 2 out of the first needle 12. In some examples, the implant delivery device 10 may have a retaining member arranged to releasably attach the housing portion 2 to the first needle 12 and / or the handle 11, and the retaining member may release the housing portion 2 after the second needle 13 is retracted and before the first needle 12 is removed from the patient.

[0110] Figure 7 , Fig. 8A and Figure 8B The first needle 12 and the second needle 13 of the above-mentioned delivery device 10 are shown. As shown, the electrode lead 3 is housed in the second needle 13, and the second needle 13 includes a groove 18 that allows the electrode lead 3 to be connected to the housing portion 2 in the first needle 12. The groove 18 extends partially along the second needle 13 from the top 15 and can extend most of the length of the second needle 13 or the entire length of the second needle 13. The second needle 13 can be in the form of a sheath. The first needle 12 houses the housing portion 2.

[0111] The first needle 12 includes a beveled tip 14. The second needle 13 includes a beveled tip 15. The beveled tips 14, 15 are sharp for piercing the patient's skin and penetrating tissue during use.

[0112] like Figure 7 As shown, the second needle 13 extends through the inner cavity of the first needle 12. In particular, as Figure 8B As shown, the first needle 12 includes a main portion 19A and a secondary portion 19B. The main portion 19A and the secondary portion 19B are merged so that the first needle 12 has a single lumen. The main portion 19A and the secondary portion 19B are shaped to define two distinct portions 19A and 19B.

[0113] The main portion 19A is shaped to accommodate the housing portion 2. In particular, the main portion 19A is sized to accommodate the housing portion 2 and has a substantially circular cross-section that maintains the housing portion 2 in axial alignment within the main portion 19A.

[0114] The secondary portion 19B is shaped to accommodate the second needle 13. In particular, the secondary portion 19B is sized to accommodate the second needle 13 and has a substantially circular cross-section that maintains the second needle 13 in axial alignment within the secondary portion 19B.

[0115] In the example, the secondary part 19B and the main part 19A each have a substantially circular cross section, and the cross sections at least partially overlap. In such an example, the housing part may be pushed to one side of the main part 19A due to the presence of the second needle 13 in the secondary part 19B.

[0116] The groove 18 in the second needle 13 is guided toward the center of the first needle 12, thereby allowing the electrode lead 3 to be connected to the housing portion 2, such as Figure 7 shown.

[0117] Thus, the first needle 12 is shaped to accommodate the housing part 2 and the second needle 13 and allow the second needle 13 to slide towards the retracted position. The positioning of the second needle 13 within the cavity of the first needle 1 advantageously means that only one puncture wound is formed in the patient's skin, because during use the first needle 12 will enlarge the puncture wound formed by the second needle 13.

[0118] In an alternative example, the second needle 13 does not enter or pass through the lumen of the first needle 12. Instead, the second needle 13 can extend through another portion of the handle 11, such as adjacent to the first needle 12.

[0119] In the above example, the second needle 13 is initially in the extended position, and the first needle 12 and the second needle 13 may be positioned in the patient's body at the same time. Fig. 9 An alternative example is shown in which the second needle 13 is initially in a retracted position. In this example, as shown, the actuation tab 4 extends from the handle 11. In the retracted position, the second needle 13 can be within the first needle 12, as shown, or side by side with the first needle 12 within the handle 11. The electrode lead 3 is partially located within the second needle 13 and is looped between the housing portion 2 and the second needle 13.

[0120] During implantation, the first needle 12 is inserted into the patient's body, wherein the implant delivery device 10 is in Fig. 9 In the illustrated configuration, the actuation tab 16 is then pushed toward the handle 11 to extend the second needle 13 beyond the first needle 12 and bring the electrode lead 3 into position. In this position, the locking mechanism 17 can be engaged so that the actuation tab 16 and the second needle 13 are locked in place.

[0121] In some examples, the implant delivery device 10 can be removed from the patient with the second needle 13 in the extended position, and a deployment member (e.g., a pusher) can be provided to push the medical implant 1 out of the first needle 12 and the second needle 13. In other examples, after being extended, the second needle 13 can then be deployed as described above. FIG. 6A to FIG. 6C The described manner pulls the actuation tab 16 away from the handle 11 to be retracted to release the electrode lead 3 and the housing portion 2 .

[0122] Fig.10 An alternative example delivery device 10 is shown. In this example, as previously described, the delivery device 10 includes a handle 11, a first needle 12 holding a housing portion 2, and a second needle 13 holding an electrode lead 3. In this example, an actuation tab 16 is arranged to be pushed toward the handle 11 (and the patient) in order to retract the second needle 13.

[0123] Specifically, as shown, the implant delivery device 10 has a rack and pinion mechanism for converting movement of the actuation tab 16 toward the handle 11 into retraction of the second needle 13 (ie, the second needle 13 moves in a direction opposite to the actuation tab 16 ).

[0124] like Fig.10As shown, the rack and pinion transmission mechanism includes a first rack portion 30A, which is attached to the second needle 13 or formed as a part of the second needle 13. The rack and pinion transmission mechanism also includes a second rack portion 30B, which is attached to the actuation tab 16 or formed as a part of the actuation tab 16. The gear 31 is rotatably mounted in the handle 11 and meshes with both the first rack portion 30A and the second rack portion 30B. The gear 31 can be mounted in the first needle 12, or, as shown, mounted behind the end of the first needle 12 in the handle 11. Therefore, when the actuation tab 16 is pushed toward the patient, the rack and pinion transmission mechanism retracts the second needle 13 away from the patient to release the electrode lead 3. In addition, when the actuation tab 16 is pushed toward the patient, the second rack portion 30B can engage and push the housing portion 2 to deploy the housing portion 2 from the first needle 12.

[0125] In some examples, the delivery device 10 may include a locking mechanism that is operable to lock the first rack portion 30A to the second rack portion 30B. When locked, this can allow the second needle 13 to be pushed into the patient's tissue without rotating the rack and gear transmission mechanism. The locking mechanism can then be unlocked to retract the second needle 13. The locking mechanism is operable to lock the first rack portion 30A and / or the second rack portion 30B to the handle 11, or it is operable to lock the rotation of the gear 31. The locking mechanism can operate at different positions of the second needle 13, so that the position of the second needle 13 can be locked at different positions between the fully extended position and the fully retracted position. In some examples, the locking mechanism can be arranged to lock the second needle 13 in the fully extended position. In other examples, the locking mechanism can additionally operate to lock the second needle 13 in the partially retracted position.

[0126] Advantageously, pushing the actuation tab 16 rather than pulling the actuation tab 16 may allow for single-handed operation of the implant delivery device 10 .

[0127] Fig.11A and Fig. 11C An alternative example delivery device 10 is shown. In this example, the delivery device 10 includes a handle 11, a first needle 12 holding a housing portion 2, and a second needle 13 holding an electrode lead 3, as previously described.

[0128] like Fig.11A and Fig. 11B As shown, in this example, before use, the electrode lead 3 extends from the end of the housing portion 2 facing the handle 11. The electrode lead 3 routes over the housing portion 2 in the first needle 12 and then enters the second needle 13. A portion of the electrode lead 3 is positioned beside the housing portion 2 in the first needle 12.

[0129] The first needle 12 includes a cutout 12a. Fig. 11B and Fig. 11C The cutout 12a extends from the tip 14 of the first needle 12 to the housing portion 2 to receive the portion of the electrode lead 3 adjacent to the housing portion 2 in the first needle 12 before use. The cutout 12a is wider than the electrode lead 3 but narrower than the housing portion 2, so the housing portion 2 is retained in the first needle 12.

[0130] like Fig. 11C As shown, during use, the second needle 13 has been retracted into the first needle 12 to deploy the top end of the electrode lead 3 (as shown in reference Figure 6B After the housing portion 2 is deployed from the first needle 12 (as described in reference Figure 6C The angle of the delivery device 13 (including the first needle 13) is changed before the above step. Fig. 11C As shown, when the angle is changed, a portion of the electrode lead 3 exits the first needle 12 through the incision 12a. In this way, one end of the electrode lead 3 can be implanted at a first angle, and the housing portion 2 can be implanted at a different second angle. This may be advantageous for providing alignment of the housing portion 2 (and any wireless power received therein) with an external (wearable) device or for making the medical implant better fit in the anatomical structure of the implantation site.

[0131] and Fig.10 As in the example, FIG. 11A to FIG. 11C In the example of , the actuation tab 16 is arranged to be pushed toward the handle 11 (and the patient) to retract the second needle 13. The implant delivery device 10 has a rack and pinion transmission mechanism for converting the movement of the actuation tab 16 toward the handle 11 into the retraction of the second needle 13 (i.e., the second needle 13 moves in the opposite direction to the actuation tab 16).

[0132] like Fig.11A As shown, the rack and pinion transmission mechanism includes a first rack portion 30A, which is attached to the second needle 13 or formed as a part of the second needle 13. The rack and pinion transmission mechanism also includes a second rack portion 30B, which is attached to the actuation tab 16 or formed as a part of the actuation tab 16. The gear 31 is rotatably mounted in the handle 11 and meshes with both the first rack portion 30A and the second rack portion 30B. The gear 31 can be mounted in the first needle 12, or, as shown, mounted behind the end of the first needle 12 in the handle 11. Therefore, when the actuation tab 16 is pushed toward the patient, the rack and pinion transmission mechanism retracts the second needle 13 away from the patient to release the electrode lead 3. In addition, when the actuation tab 16 is pushed toward the patient, the second rack portion 30B can engage and push the housing portion 2 to deploy the housing portion 2 from the first needle 12.

[0133] Advantageously, pushing the actuation tab 16 rather than pulling the actuation tab 16 may allow for single-handed operation of the implant delivery device 10 .

[0134] refer to Figures 9 to 11C The example delivery devices described include those described in reference FIG. 5A to FIG. 5E The power delivery system 37 described above. In particular, the power delivery system 37 includes a power supply 38. In some examples, as shown in FIG. Figure 5A and Figure 5B As described, the power delivery system 37 includes connectors 39a, 39b, 40a, 40b, which are arranged to connect to corresponding power terminals 33a, 33b, 36a, 36b on the housing portion 2. In other examples, the power delivery system 37 includes a wireless power transmitter 42, which is arranged to provide wireless power to the wireless power receivers 35, 35a in the housing portion 2, as shown in reference FIG. 5C to FIG. 5E In one example, the wireless power transmitter 42 is mounted to the second gear portion 30B so that when the second needle 13 is retracted, the wireless power transmitter moves closer to the housing portion 2 , thereby allowing the medical implant 1 to be powered to test the position of the electrode lead 3 .

[0135] FIG. 12A to FIG. 12D Another example of a delivery device 10 is shown that includes a power delivery system 37 similar to that described above. Specifically, FIG. 12A to FIG. 12D A delivery system 10 is shown having a delivery sheath including a cannula 53 that holds the medical implant 1 prior to and during implantation. The entire medical implant 1 (which may be a reference FIG. 3A to FIG. 3E Any medical implant 1) described is held within a cannula 53. The cannula 53 may be positioned percutaneously and the medical implant 1 may be deployed from the cannula 53, for example by a pusher 54 as shown.

[0136] exist Fig. 12A In the example of the delivery system 10, a reference Figure 3A The medical implant 1 described herein, wherein the housing portion 2 comprises a first power terminal 33a and a second power terminal 33b formed on a side wall. It will be appreciated that Fig. 12A The delivery system 10 can also be used with Figure 3D. As shown, the power delivery system 37 includes a first connector 55a and a second connector 55b, which are arranged in the sleeve 53 and are arranged to connect with the first power terminal 33a and the second power terminal 33b on the housing portion 2. The first connector 55a and the second connector 55b allow the medical implant 1 to slide a short distance in the sleeve 53 while maintaining electrical contact, thereby allowing the medical implant 1 to be partially pushed out of the sleeve 53 to expose the electrode 4 before operating the power delivery system 37 to test the position of the electrode lead 3 as described above. In particular, when the first power terminal 33a and the second power terminal 33b on the housing portion 2 of the medical implant 1 extend along a portion of the length of the housing portion 2, the housing portion 2 can move along the sleeve 53 and will maintain electrical contact. The power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) 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 when it is located in the delivery device 10.

[0137] Alternatively, Fig. 12A The delivery device 10 shown in FIG. 1 may be adapted to be implanted without the electrode lead 3. Figure 3E The medical implant 1 shown in . In this example, the first connector 55a and the second connector 55b of the power delivery system 37 are connected to the first power terminal 33a and the second power terminal 33b on the housing part 2 of the medical implant 1 to power the medical implant 1 during implantation as described above.

[0138] exist Fig. 12B In the example of the delivery system 10, a reference Figure 3BThe medical implant 1 described, wherein the housing portion 2 includes a first power terminal 36a and a second power terminal 36b formed at one end. As shown, the power delivery system 37 includes a first connector 56a and a second connector 56b, which are arranged in the sleeve 53 and arranged to be connected to the first power terminal 36a and the second power terminal 36b on the housing portion 2. A power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) is connected to the first connector 56a and the second connector 56b. Therefore, the medical implant 1 can be powered by the power source 38 when it is located in the delivery device 10. In this example, the power source 38 and the first connector 56a and the second connector 56b are formed on a mounting member 57 that can be slidably moved in the sleeve 53. In this way, the pusher 54 can push the mounting member 57 and the medical implant 1 toward the outlet of the sleeve 53, and the power connection between the first power terminal 36a and the second power terminal 36b and the first connector 56a and the second connector 56b will be maintained. Alternatively, the mounting member 57 may be fixed within the sleeve 53 , and the pusher 54 may pass through or around the mounting member 57 to contact the housing portion 2 of the medical implant 1 .

[0139] exist Fig. 12C In the example of the delivery system 10, a reference Figure 3C The medical implant 1 described above, wherein the housing part 2 comprises a wireless power receiver 35a. Additionally or alternatively, Fig. 12C The delivery system 10 may be used with a medical implant having a single wireless power receiver 35 without any additional connectors or the like.

[0140] like Fig. 12C As shown, the power delivery system 37 includes a wireless power transmitter 58 arranged in the sleeve 53 to wirelessly couple with the wireless power receiver 35, 35a of the medical implant 1. The wireless power transmitter 58 is connected to the power source 38, which can be located outside the sleeve 53, such as in the handle 11. In an example, the wireless power transmitter 58 can be coupled to the power source 38 through electrical connectors 59a, 59b, which allow the wireless power transmitter 58 to slide a short distance in the sleeve 53 so that the medical implant 1 can be partially pushed out of the sleeve 53 to expose the electrode 4 before operating the power delivery system 37 to test the position of the electrode lead 3 as described above. Alternatively, the wireless power transmitter 58 can be fixed in the sleeve 53, and the pusher 5 can pass through or bypass the wireless power transmitter 58 to contact the housing portion 2 of the medical implant 1. The power source 38 can be a battery or a connection to an external power source (external battery or mains). Thus, the medical implant 1 may be powered by the power source 38 while located within the delivery device 10 .

[0141] exist Fig.12D In the example of the delivery system 10, a reference Figure 3C The medical implant 1 described above, wherein the housing part 2 comprises a wireless power receiver 35a. Additionally or alternatively, Fig.12D The delivery system 10 may be used with a medical implant having a single wireless power receiver 35 without any additional connectors or the like.

[0142] like Fig.12D As shown, the power delivery system 37 includes a wireless power transmitter 58 arranged in the sleeve 53 to wirelessly couple with the wireless power receiver 35, 35a of the medical implant 1. The wireless power transmitter 58 is connected to the power source 38. The power source 38 can be a battery or a connection to an external power source (external battery or mains). In this example, the power source 38 and the wireless power transmitter 58 are formed on a slidable mount 59, which is slidably movable in the sleeve 53. In this way, the pusher 54 can push the slidable mount 59 and the medical implant 1 toward the outlet of the sleeve 53, and the wireless power connection can be maintained. In this way, the electrode 4 can be exposed and the medical implant 1 can be powered before deployment to test the position of the electrode lead 3.

[0143] In some examples, such as reference FIG. 12A to FIG. 12D The cannula 53 may be a needle, for example having a bevel tip.

[0144] FIG. 13A to FIG. 13C Another example of a delivery device 10 including a power delivery system 37 as described above is shown. Specifically, FIG. 13A to FIG. 1 3D shows a delivery system 10 with 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 3. The first portion 61 and the second portion 62 are fixed to each other and have different diameters (the second portion 62 is smaller than the first portion 61). The second portion 62 includes a groove extending from the first portion 61 to its top along its length. The first portion 61 also has a groove or opening in the side that is aligned with the groove of the second portion 62. In this way, the medical implant 1 can be deployed by pushing the housing portion 2 out of the first portion 61 via the groove or opening by the pusher 54, and the delivery device 10 can be retracted to fully implant the medical implant 1.

[0145] exist Fig.13A In the example of the delivery system 10, a reference Figure 3A The medical implant 1 described herein, wherein the housing portion 2 comprises a first power terminal 33a and a second power terminal 33b formed on a side wall. It will be appreciated that Fig.13A The delivery system 10 can also be used with Figure 3D . As shown, the power delivery system 37 includes a first connector 60a and a second connector 60b, which are arranged in a first portion 61 of the delivery system 10 and are arranged to connect with a first power terminal 33a and a second power terminal 33b on the housing portion 2. The first connector 60a and the second connector 60b allow the medical implant 1 to slide a short distance within the first portion 61 while maintaining electrical contact, thereby allowing the electrode lead 3 to be partially pushed out of the second portion 62 to expose the electrode 4 before operating the power delivery system 37 as described above to test the position of the electrode lead 3. In particular, when the first power terminal 33a and the second power terminal 33b on the housing portion 2 of the medical implant 1 extend along a portion of the length of the housing portion 2, the housing portion 2 can move along the first portion 61 and will maintain electrical contact. A power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) is connected to the first connector 60a and the second connector 60b. Therefore, the medical implant 1 can be powered by the power source 38 when it is located within the delivery device 10.

[0146] Alternatively, Fig.13A The delivery device 10 shown in FIG. 1 may be adapted to be implanted without the electrode lead 3. Figure 3E . In this example, the second portion 62 may be omitted or provided only for piercing the patient's tissue. As described above, the first connector 60a and the second connector 60b of the power delivery 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 to power the medical implant 1 during implantation.

[0147] exist Fig. 13B In the example of the delivery system 10, a reference Figure 3BThe medical implant 1 described, wherein the housing portion 2 includes a first power terminal 36a and a second power terminal 36b formed at the end. As shown, the power delivery system 37 includes a first connector 63a and a second connector 63b, which are arranged in the first portion 61 and arranged to be connected to the first power terminal 36a and the second power terminal 36b on the housing portion 2. A power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) 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 when it is located in the delivery device 10. In this example, the first connector 63a and the second connector 63b are formed on a mounting member that is slidably movable in the first portion 61. In this way, the pusher 54 can push the mounting member and the medical implant 1 toward the opening in the first portion, and the power connection between the first power terminal 36a and the second power terminal 36b and the first connector 63a and the second connector 63b will be maintained. Alternatively, the mounting may be fixed within the first portion 61 and the pusher 54 may pass through or around the mounting to contact the housing portion 2 of the medical implant 1 .

[0148] exist Fig. 13C In the example of the delivery system 10, a reference Figure 3C The medical implant 1 described above, wherein the housing part 2 comprises a wireless power receiver 35a. Additionally or alternatively, Fig. 13C The delivery system 10 may be used with a medical implant 1 having a single wireless power receiver 35 without any additional connectors or the like.

[0149] like Fig. 13C As shown, the power delivery system 37 includes a wireless power transmitter 64 arranged in the first part 61 to wirelessly couple with the wireless power receiver 35, 35a of the medical implant 1. The wireless power transmitter 64 is connected to the power source 38. In this example, the power source 38 is located in the handle 11. The power source 38 can be a battery or a connection to an external power source (external battery or mains). Therefore, the medical implant 1 can be powered by the power source 38 when it is located in the delivery device 10. The wireless power transmitter 64 can be moved by the pusher 54 during the deployment of the medical implant 1, or it can be shaped to allow the pusher 54 to pass through or bypass the wireless power transmitter 64 in the first part 61 to contact the housing part 2 of the medical implant 1.

[0150] Fig.14A and Fig. 14B Another example of a delivery device 10 including a power delivery system 37 as described above is shown. Specifically, FIG. 14A to FIG. 14BA delivery system 10 is shown for first implanting the housing portion 2 of a medical implant 1 and then implanting the electrode lead 3. As shown, the delivery system 10 has a delivery sheath including a first needle 65 holding the housing portion 2 of the medical implant 1 and a second needle 66 holding the electrode lead 3. The second needle 66 is referred to as FIG. 6A to FIG. 6C The housing portion 2 is oriented within the first needle 65 so that the electrode lead 3 is guided away from the tip 67 of the first needle 65. The electrode lead 3 is annular and is received in the second needle 66, which has a shape similar to Figure 7 18 shown in the figure. During use, the first needle 65 is percutaneously positioned to deploy the housing portion 2, and a pusher (not shown) or a second needle 66 is used to at least partially deploy the housing portion 2 through the top end 67. Once the housing portion 2 has been at least partially deployed, the second needle 66 can be extended to deploy the electrode lead 3. The second needle 66 can then be retracted to leave the electrode lead 3 in place. During implantation, in order to test the position of the electrode lead 3, the second needle 66 can be partially retracted to expose the electrode 4, and the power delivery system 37 can be operated to power the medical implant 1.

[0151] exist Fig.14A In the example of the delivery system 10, a reference Figure 3A The medical implant 1 described herein, wherein the housing part 2 comprises a first power terminal 33a and a second power terminal 33b formed on the outer shell of the housing part 2. It will be appreciated that Fig.13A The delivery system 10 can also be used with Figure 3D . As shown, the power delivery system 37 includes a first connector 68a and a second connector 68b, which are arranged in the first needle 65 of the delivery system 10 and are arranged to be connected to the first power terminal 33a and the second power terminal 33b on the housing portion 2. The first connector 68a and the second connector 68b allow the medical implant 1 to slide a short distance in the first needle 66 while maintaining electrical contact, thereby allowing the housing portion 2 to be partially pushed out of the first needle 65 before operating the power delivery system 37 to test the position of the electrode lead 3 as described above. In particular, when the first power terminal 33a and the second power terminal 33b on the housing portion 2 of the medical implant 1 extend along a portion of the length of the housing portion 2, the housing portion 2 can move along the first needle 65 and will maintain electrical contact. The power source 38 (e.g., a battery or a connection to an external power source (external battery or mains)) 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.

[0152] Alternatively, Fig.14AThe delivery device 10 shown in FIG. 1 may be adapted to be implanted without the electrode lead 3. Figure 3E . In this example, the second needle 66 may be omitted or provided only for piercing the patient's tissue. As described above, the first connector 68a and the second connector 68b of the power delivery 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 to power the medical implant 1 during implantation.

[0153] exist Fig. 14B In the example of the delivery system 10, a reference Figure 3C The medical implant 1 described above, wherein the housing part 2 comprises a wireless power receiver 35a. Additionally or alternatively, Fig. 14B The delivery system 10 may be used with a medical implant having a single wireless power receiver 35 without any additional connectors or the like.

[0154] like Fig. 14B As shown, the power delivery system 37 includes a wireless power transmitter 69 arranged in the handle 11 to wirelessly couple with the wireless power receiver 35, 35a of the medical implant 1. The wireless power transmitter 69 is connected to the power source 38. In this example, the power source 38 is located in the handle 11. The power source 38 can be a battery or a connection to an external power source (external battery or mains). Therefore, the medical implant 1 can be powered by the power source 38 when it is located in the delivery device 10.

[0155] Fig.15 The use of the above reference during implantation is shown FIG. 5A to FIG. 14B Testing of a medical implant 1 by any of the described delivery devices 10. Each example delivery device 10 comprises a delivery sheath holding a medical implant 1 and a power delivery system 37 for powering the medical implant 1 within the delivery sheath. Fig.15 Shows Figures 3A to 9 The specific example delivery device 10 of FIG. 1 is described herein, but it will be appreciated that the same testing process can be used for any delivery device 10 described herein.

[0156] like Fig.15 As shown, the delivery sheath (in this example, the first needle 12 and the second needle 13) have been percutaneously positioned through the patient's skin 5 and into the tissue 8. The electrode 4 (in this example, the electrode 4 on the electrode lead 3) has been guided to the vicinity of the nerve 9, for example, using an ultrasound scanner. In this example, by partially retracting the second needle 13, the electrode 4 has been exposed. In this position, the power delivery system 37 can be operated to power the medical implant 1 and test the position of the electrode 4 relative to the nerve 9.

[0157] In some examples, the medical implant 1 is a neurostimulator implant operable to stimulate a nerve 9 by providing an electrical signal via the electrode 4. In this example, the position of the neurostimulator implant may be tested to ensure that the electrical signal provided by the electrode 4 has the desired effect on the nerve 9.

[0158] In some examples, an operator may use visual or patient feedback to determine whether the medical implant 1 is having the desired effect. For example, if the medical implant 1 is used to address sleep apnea, the visual feedback may include tongue position (e.g., the degree to which the tongue protrudes). Other forms of visual or patient feedback may include patient touch testing (to test sensation) or patient feedback on pain severity / tingling sensation. In one example, the medical implant 1 may be implanted to address a urinary indication, in which case visual feedback may be provided by the passage of urine.

[0159] like Fig.15 As shown, the delivery device 10 may include a sensor 45. In the example shown, the sensor 45 may be attached to the patient, in particular the patient's skin 5. The sensor may be adhered to the skin 5, or otherwise held in place, such as by a band or as a wearable. In other examples, the sensor 45 may be provided in the delivery device 10 itself, such as in the handle 11. In other examples, the sensor 45 may be provided in a wearable device that accompanies the neurostimulator implant, such as a wearable device that provides wireless power and control after the implant is complete. In some examples, the sensor 45 may be provided in the medical implant 1.

[0160] The sensor 45 is configured to detect the patient's response when power is provided to the neurostimulator implant 1 during implantation. In some examples, the sensor 45 can detect the patient's motor response in response to testing of the neurostimulator implant 1. The motor response can be detected by an accelerometer (e.g., a microelectromechanical system, MEMS, sensor), or by an electromyogram, EMG, sensor, or by an ultrasonic sensor. In other examples, the sensor 45 can detect changes in the patient's blood flow, for example using an ultrasonic sensor or other blood flow sensor. In some examples, the sensor 45 can be a bioimpedance-impedance blood pressure sensor and can be integrated into the electrode 4 of the medical implant 1. In some examples, the sensor 45 can be a radar-based blood pressure sensor. In some examples, the sensor 45 can detect the position of a body part. For example, if sleep apnea is being treated, the sensor 45 can detect the position of the tongue.

[0161] In some examples, the medical implant is a diagnostic implant 1 operable to detect neural signals in a nerve. In other examples, the diagnostic implant 1 can detect one or more patient vital signs, such as body temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentration (e.g., oxygen, carbon dioxide, carbon monoxide). In this example, the position of the diagnostic implant 1 can be tested to ensure that the electrode 4 is properly positioned relative to the nerve 9 in order to detect the neural signal.

[0162] In such an example, the delivery system 10 for the diagnostic implant 1 may include a device similar to Fig.15 45. In the example shown, the sensor 45 is attachable to the patient, in particular the patient's skin 5. The sensor 45 may be adhered to the skin 5, or otherwise held in place, such as by a band or as a wearable. In other examples, the sensor 45 may be disposed in the delivery device 10 itself, such as in the handle 11. In other examples, the sensor 45 may be disposed in a wearable device that accompanies the neurostimulator implant, such as a wearable device that provides wireless power and control after the implant is complete.

[0163] In an example, the sensor 45 can detect the same neural signals as the diagnostic implant 1 in order to test the diagnostic implant 1. For example, the sensor 45 can be arranged to detect one or more neural signals, including action potentials (nerve impulses), electrical impedance in tissue, neural responses (e.g., neural response amplitudes), electrical interference, motor neuron responses (e.g., using electromyography (EMG)), electrical skin activity (EDA), and / or heart rate characteristics (e.g., using electrocardiography (ECG)). In other examples, the diagnostic implant can detect one or more patient vital signs, such as body temperature, heart rate, respiratory rate, blood pressure, and / or blood gas concentrations (e.g., oxygen, carbon dioxide, carbon monoxide).

[0164] like Fig.15 As shown, the delivery device 10 may also include a controller 46. The controller 46 may be embedded in the handle 11, or provided separately, such as in a separate device. The controller 46 communicates with the sensor 45 and the power delivery system 37. The communication is provided by a communication channel 44, which may be a wired connection or a wireless communication channel.

[0165] The controller 46 may be configured to control the power delivery system 37. For example, a user input may instruct the controller 46 to control the power delivery system 37 to provide power to the medical implant 1. The user input may be provided via a button or switch on the delivery device 10, or via a graphical user interface GUI 43 as shown.

[0166] In an example, the controller 46 may be adapted to control the power delivery system 37 to power the medical implant 1 based on (i.e., in response to) the characteristic detected by the sensor 45. In particular, the controller 46 may be configured to test the position of the medical implant 1 by powering the medical implant through the power delivery system 37 and using data from the sensor 45 to assess the positioning of the medical implant 1. The controller 46 may be configured to increase or decrease the power provided to the medical implant 1 in response to the characteristic detected by the sensor 45. The controller 46 may additionally communicate directly and wirelessly with the medical implant 1 to control the medical implant 1 during testing.

[0167] like Fig.15 As shown, the delivery device 10 may further include a graphical user interface GUI 43. The GUI 43 may be mounted to the handle 11 or provided separately. The GUI 43 communicates with the controller 46 and may be controlled by the controller 46. The controller 46 may display one or more of the following on the GUI 43:

[0168] the characteristics of the power supplied to the medical implant (e.g., frequency, voltage, current); the operating characteristics of medical implants (e.g., frequency, amplitude); one or more characteristics detected by sensor 45; and / or One or more threshold values ​​for a characteristic detected by sensor 45 .

[0169] In some examples, the controller 46 displays an overlay or comparison of the operating characteristics of the medical implant 1 with the data received from the sensor 45 on the GUI 43. Such an overlay or comparison may illustrate the effectiveness of the positioning and operation of the medical implant 1.

[0170] In some examples, the delivery device 10 may include a user input device, such as a button or switch. In an example, the GUI 43 is a touch screen device operable as a user input device. In response to user input through the user input device, the controller 46 may be configured to perform a test procedure, for example, by powering the medical implant 1 and detecting a characteristic of the patient through the sensor 45.

[0171] In an example, the GUI 43 may include an input for patient / visual feedback. For example, the GUI 43 may include an input for a user to input a rating of a patient's pain or tingling sensation. In an example, the GUI 43 may include a user input for inputting information about the feedback, such as to evaluate or confirm the effectiveness of the position of the medical implant 1. In other examples, the GUI 43 may include a user input for confirming that the feedback has been observed.

[0172] Figures 16 to 19A further example of a delivery device 10 is shown in which the delivery device 10 includes an impedance sensor system 47 arranged to detect changes in tissue type at or near the tip of the delivery sheath by measuring electrical impedance, as described below.

[0173] Fig.16 Shows the reference FIG. 5A to FIG. 11B An example of a delivery device 10 is described, wherein the delivery device 10 has a delivery sheath including a first needle 12 holding a housing portion 2 of a medical implant 1 and a second needle 13 holding an electrode lead 3. It will be appreciated that the impedance sensor system 47 described below can be used with reference to FIG. 5A to FIG. 5E The power delivery system 37 described may be used in combination, or the power delivery system 37 may be omitted.

[0174] like Fig.16 As shown, the impedance sensor system 47 includes a first electrode 48 positioned at or near the tip 15 of the second needle 13. The first electrode 48 is connected to an impedance analyzer 50, which in this example is located in the handle 11. The first electrode 48 can be a separate component attached to the second needle 13, or the second needle 13 can include an electrically insulating coating with an opening that exposes a portion of the second needle 13 and defines the first electrode 48.

[0175] The impedance sensor system 47 also includes a second electrode 49, which is arranged to contact the patient at a position spaced apart from the first electrode 48. In the example shown, the second electrode 49 is positionable (e.g., adhered) against the patient's skin 5. However, the second electrode 49 may alternatively protrude from the handle 11, or the second electrode 49 may be provided on the first needle 12, or the second electrode 49 may be provided on the second needle 13, spaced apart from the first electrode 48 and electrically insulated.

[0176] Both the first electrode 48 and the second electrode 49 are connected to an impedance analyzer 50, which detects an electrical impedance across the first electrode 48 and the second electrode 49. The electrical impedance may indicate the type of tissue near the first electrode 48 (i.e., at the tip 15 of the second needle 13). For example, when the first electrode 48 is within the subcutaneous tissue 6, the detected electrical impedance may have a first value, when the first electrode 48 is within the muscle 8, the detected electrical impedance may have a second value, and when the first electrode 48 is near the nerve 9, the detected electrical impedance may have a third value. Therefore, the detected electrical impedance may indicate the location of the first electrode 48 (and the tip 15 of the second needle 13) in the patient's tissue.

[0177] When detecting electrical impedance, tissue boundaries are particularly evident, so changes 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 an example, the detected electrical impedance can be used to determine when the tip 15 of the second needle 13 approaches the nerve 9.

[0178] In an example, the detected electrical impedance can be used in conjunction with ultrasound to guide the second needle 13 to an appropriate implantation location. In particular, ultrasound can be used to guide the second needle 13 through the skin 5 and muscle 8 toward the nerve 9, and the detected electrical impedance can be used to determine when 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 nerve 9 from being pierced by the second needle 13.

[0179] like Fig.16 As shown, the impedance analyzer 50 communicates with the controller 51. The controller 51 can analyze the detected electrical impedance determined by the impedance analyzer. The controller 51 and the impedance analyzer 50 can be a single component. The delivery device 10 can also include a graphical user interface GUI 52 in communication with the controller 51. The controller 51 can display the detected electrical impedance on the GUI 52. The controller 51 can also display one or more thresholds of the electrical impedance on the GUI 52. When the first electrode 48 has passed through the patient's skin 5 and tissue, the controller 51 can display the historical track of the detected electrical impedance on the GUI 52. The controller 51 can compare the detected electrical impedance with a database or other comparable data, for example, to determine the tissue type or anatomical feature based on the detected electrical impedance and in particular based on the change in the detected electrical impedance. The database or comparable data can be provided at a distributed location (e.g., on a server), and the impedance analyzer can communicate via a wireless communication channel (e.g., via the Internet).

[0180] Fig.17 Another example delivery system 10 is shown with an impedance sensor system 47. This example is based on reference FIG. 12A to FIG. 12D The delivery device 10 described herein has a delivery sheath including a cannula 53 that holds the medical implant 1. It will be appreciated that the impedance sensor system 47 described below may be used in conjunction with the delivery device 10 of the present invention. FIG. 12A to FIG. 12D The power delivery system 37 described may be used in combination, or the power delivery system 37 may be omitted.

[0181] like Fig.17 As shown, the sleeve 53 includes a first electrode 48 formed at or near a top end 70 of the sleeve 53. The first electrode 48 may be a separate component attached to the sleeve 53, or the sleeve 53 may include an electrically insulating coating having an opening that exposes a portion of the sleeve 53 and defines the first electrode 48.

[0182] The impedance sensor system 47 also includes a second electrode 49 that is arranged to contact the patient at a location spaced apart from the first electrode 48. In the example shown, the second electrode 49 is positionable (e.g., adhered) against the patient's skin 5. However, the second electrode 49 may alternatively protrude from the handle 11, or the second electrode 49 may be disposed on the sleeve 53, spaced apart from the first electrode 48 and electrically insulated.

[0183] Fig.17 The impedance sensor system 47 is similar to the above reference Fig.16 Works the same way as described.

[0184] In some examples, Fig.17 The cannula 53 shown in FIG. 5 may be a needle having a beveled tip.

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

[0186] like Fig.18 As shown, the second portion 62 includes a first electrode 48 formed at or near a top end 71 of the second portion 62. The first electrode 48 can be a separate component attached to the second portion 62, or the second portion 62 can include an electrically insulating coating having an opening that exposes a portion of the second portion 62 and defines the first electrode 48.

[0187] The impedance sensor system 47 also includes a second electrode 49 that is arranged to contact the patient at a location spaced apart from the first electrode 48. In the example shown, the second electrode 49 is positionable (e.g., adhered) against the patient's skin 5. However, the second electrode 49 may alternatively protrude from the handle 11, or the second electrode 49 may be provided on the first portion 61 or on the second portion 62, spaced apart from the first electrode 48 and electrically insulated.

[0188] Fig.18 The impedance sensor system 47 is similar to the above reference Fig.16 Works the same way as described.

[0189] Fig.19 Another example delivery system 10 is shown with an impedance sensor system 47. This example is based on reference Fig.14A and Fig. 14B The delivery device 10 described herein has a delivery sheath including a first needle 65 and a second needle 66 arranged to deliver the medical implant 1 in opposite orientations. It will be appreciated that the impedance sensor system 47 described below may be used in conjunction with the reference Fig.14A and Fig. 14B The power delivery system 37 described may be used in combination, or the power delivery system 37 may be omitted.

[0190] like Fig.19 As shown, the second needle 66 includes a first electrode 48 formed at or near a 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 portion of the second needle 66 and defines the first electrode 48.

[0191] The impedance sensor system 47 also includes a second electrode 49 that is arranged to contact the patient at a location spaced apart from the first electrode 48. In the example shown, the second electrode 49 is positionable (e.g., adhered) against the patient's skin 5. However, the second electrode 49 may alternatively protrude from the handle 11, or the second electrode 49 may be provided on the first needle 65 or on the second needle 66, spaced apart from the first electrode 48 and electrically insulated.

[0192] Fig.19 The impedance sensor system 47 is similar to the above reference Fig.16 Works the same way as described.

[0193] In some examples, one or more of the electrodes 4 on the electrode lead 3 of the medical implant can be used as one of the electrodes for detecting impedance. For example, the first electrode 4 on the electrode lead 3 can be the first electrode of the impedance sensor, and the second electrode 4 on the electrode lead 3 can be the second electrode of the impedance sensor. Alternatively, one electrode (4, see Figure 1 ) may be the first electrode of the impedance sensor, and the second electrode may be Figures 16 to 19 Alternatively, an electrode (4, see Figure 1 ) may be a first electrode of an impedance sensor, and a second electrode may be formed on a delivery sheath, e.g., as Fig.16 On the second needle 13 shown, or as Fig.17 On the sleeve 53 shown, or as Fig.18 On the second portion 62 shown, or as Fig.19 On the first needle 65 shown. In each example, there are first and second electrodes separated from each other and used to detect impedance to detect tissue boundaries near the electrode lead 3.

[0194] Fig. 20 The operation of various delivery devices 10 for implanting a medical implant 1 is schematically shown. The method shown can be used with any medical implant 1 described herein, and with any delivery device 10 described herein. The method uses a delivery device 10 holding a medical implant 1 as previously described.

[0195] like Fig. 20 As shown, the method includes percutaneously positioning a delivery sheath of a delivery device in the patient's tissue 78. The delivery sheath passes through the skin and into the underlying tissue of the patient. An ultrasound scanner can be used to visualize the position of the delivery sheath, allowing the operator to guide the delivery sheath toward the nerve.

[0196] The method also includes detecting an electrical impedance 79 between the tip of the delivery sheath and another location on the patient. Figures 16 to 19 The impedance sensor system 47 described above detects electrical impedance. As described above, the detected electrical impedance can indicate the proximity of the delivery sheath to the nerve tissue boundary, and thus the operator can use the detected electrical impedance to ensure close proximity of the delivery sheath to the nerve without damaging the nerve.

[0197] In some examples, the above method can be used to properly position a delivery sheath relative to a nerve to implant a medical implant. In such an example, the method can include releasing the medical implant from the delivery device and withdrawing the delivery sheath 84 from the patient.

[0198] Optionally, the method may include partially exposing the electrode 80 of the medical implant. In various examples as described above, this may include retracting a portion of the delivery sheath, or partially pushing the medical implant out of the delivery sheath.

[0199] The method may further include powering a medical implant within the delivery device 81. In particular, as described in detail above, a power delivery system of the delivery device may be operated to power a medical implant within the delivery device.

[0200] The method may also include evaluating the position of the electrode 82. In particular, if the medical implant comprises a neurostimulator implant, the method may also include detecting the patient's response to evaluate the position of the electrode. Alternatively, if the medical implant is a diagnostic implant, the method may include testing diagnostic readings 82 to evaluate the position of the electrode.

[0201] Based on the assessed position of the electrode, the method may include repositioning the delivery sheath and electrode 83. Once the electrode has been repositioned, the position of the electrode may be assessed again 82, and so on, until the position of the electrode is acceptable.

[0202] Finally, the method may include deploying the medical implant and withdrawing the delivery sheath 84 from the patient.

[0203] Throughout the description and claims of this specification, the words "comprise" and "contain" and their variations mean "including but not limited to", and they are not intended to (and do not) exclude other components, integers or steps. Throughout the description and claims of this specification, the singular encompasses the plural, unless the context requires otherwise. In particular, where the indefinite article is used, this specification should be understood to contemplate the plural as well as the singular, unless the context requires otherwise.

[0204] Features, integers, characteristics or groups described in conjunction with a particular aspect, embodiment or example of the invention will be understood to be applicable to any other aspect, embodiment or example described herein unless incompatible therewith. All features disclosed in this specification (including any accompanying claims, abstract and drawings) and / or all steps of any method or process so disclosed may be combined in any combination, except combinations where at least some of such features and / or steps are mutually exclusive. The invention is not limited to the details of any foregoing embodiments. The invention extends to any novel one or any novel combination of features of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one or any novel combination of steps of any method or process so disclosed.

Claims

1. A delivery device for percutaneously implanting a medical implant into a patient's tissue, the delivery device comprising: a delivery sheath adapted to at least partially surround the medical implant and carry the medical implant for percutaneous delivery into patient tissue, and A power delivery system is adapted to provide electrical power to the medical implant within the delivery sheath.

2. The conveying device according to claim 1, wherein: The medical implant includes a power terminal, and wherein the power delivery system includes an electrical contact disposed in the delivery sheath for making an electrical connection with the power terminal of the medical implant.

3. The conveying device according to claim 1, wherein: The medical implant comprises a wireless power receiver, and wherein the power transfer system comprises a wireless power transmitter arranged to transmit wireless power to the wireless power receiver of the medical implant.

4. The conveying device according to claim 3, wherein: The wireless power transmitter is disposed in the delivery sheath.

5. The delivery device of claim 3, further comprising a guide adapted to constrain the position and orientation of the delivery sheath relative to a patient during use, and wherein the power delivery system is disposed in the guide.

6. The delivery device according to any one of claims 1 to 5, further comprising a power source such as a battery, or a connector for an external power source such as mains or an external battery, or a wireless power receiver for coupling with an external wireless power transmitter.

7. The conveying device according to any one of claims 1 to 6, wherein: The delivery device includes a handle, and the delivery sheath extends from the handle.

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

9. The conveying device according to claim 8, wherein: At least a portion of the delivery sheath is retractable to release the medical implant into patient tissue.

10. The conveying device according to any one of claims 7 to 9, wherein: The delivery sheath comprises a needle or a cannula.

11. The delivery device according to any one of claims 1 to 10, wherein: The medical implant includes a housing portion and an elongated electrode lead extending from the housing portion, and wherein the delivery sheath is adapted to carry the housing portion for percutaneous delivery in patient tissue.

12. The delivery device according to claim 11, wherein: The delivery sheath is adapted to also carry the elongated electrode lead for percutaneous delivery in patient tissue.

13. The delivery device according to claim 12, wherein: The delivery sheath includes a retractable portion adapted to carry the elongated electrode lead for percutaneous delivery in patient tissue.

14. The delivery device according to any one of claims 1 to 13, wherein: The medical implant is a neurostimulator implant, and wherein the delivery device further comprises a sensor operable to detect a response of the patient when the power delivery system provides power to the neurostimulator implant during transcutaneous delivery.

15. The delivery device according to claim 14, wherein: The sensor is configured to detect a movement response of the patient.

16. A delivery device according to claim 14 or claim 15, wherein: The sensor is configured to detect neural signals.

17. The delivery device of any one of claims 14 to 15, further comprising a graphical user interface operable to display information received from the sensor.

18. A medical implant for implantation into tissue of a patient, the medical implant comprising: a wireless power receiver, and A power terminal is used to establish an electrical connection with an electrical connector of a delivery device during implantation of the medical implant.

19. The medical implant of claim 18, further comprising a housing portion, and wherein the power terminals are disposed on the housing portion.

20. The medical implant of claim 19, further comprising an elongated electrode lead extending from the housing portion, the elongated electrode lead comprising an electrode.

21. A medical implant for implantation into tissue of a patient, the neurostimulator implant comprising: a first wireless power receiver for wireless power coupling with an external wireless power transmitter when implanted in a patient, and A second wireless power receiver is configured to wirelessly power couple with a wireless power transmitter of a delivery device during implantation of the medical implant.

22. A medical implant for implantation in patient tissue, the medical implant comprising a wireless power receiver, the wireless power receiver being selectively tuned to receive wireless power transmissions from an external wireless power transmitter when implanted in the patient, and to receive wireless power transmissions from a wireless power transmitter of a delivery device during implantation of the medical implant.

23. The medical implant according to any one of claims 18 to 22, wherein The medical implant is a neurostimulator implant or a diagnostic implant.

24. A method of percutaneously implanting a medical implant into tissue of a patient, the method comprising: providing a delivery device having a power delivery system and a delivery sheath carrying the medical implant, percutaneously positioning the delivery sheath in tissue of a patient, and The position of the medical implant is tested by supplying power to the medical implant within the delivery sheath via the power delivery system of the delivery device.

25. The method of claim 24, further comprising exposing electrodes of the medical implant while testing the position of the medical implant.

26. The method of claim 24 or claim 25, further comprising repositioning the delivery sheath based on feedback from testing the position of the medical implant.

27. The method according to any one of claims 24 to 26, wherein: The medical implant comprises a neurostimulator implant, and wherein the method further comprises detecting a patient's response while testing the position of the neurostimulator implant.

28. The method according to claim 27, wherein: Monitoring the patient's response includes monitoring the patient's movement response.

29. The method according to claim 27, wherein: Monitoring the patient's response includes monitoring the patient's neural signals.

30. The method of any one of claims 27 to 29, further comprising displaying information received from the sensor on a graphical user interface.

31. The method of any one of claims 27 to 30, further comprising displaying information regarding the operation of the medical implant on a graphical user interface.

32. A delivery device for percutaneously implanting a medical implant into tissue of a patient, the delivery device comprising: a delivery sheath adapted to at least partially surround the medical implant and carry the medical implant for percutaneous delivery into patient tissue, and an impedance sensor comprising a first electrode and a second electrode, the first electrode and the second electrode being arranged to contact the patient at spaced-apart locations, Wherein the impedance sensor is operable to detect electrical impedance between the first electrode and the second electrode to detect changes in tissue at the delivery sheath during percutaneous delivery of the medical implant.

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

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

35. A delivery device according to any one of claims 32 to 34, wherein: The second electrode can be positioned against the patient's skin proximate to the transcutaneous delivery site.

36. The delivery device of any one of claims 32 to 35, further comprising an impedance analyzer configured to analyze the detected electrical impedance.

37. The delivery device of claim 36, wherein: The impedance analyzer is configured to compare the detected electrical impedance to a threshold value.

38. A delivery device according to claim 36 or claim 37, further comprising a graphical user interface for displaying information received from the impedance analyser.

39. The delivery device of any one of claims 32 to 38, further comprising a power delivery system adapted to provide electrical power to the medical implant within the delivery sheath.

40. A method of percutaneously implanting a medical implant into tissue of a patient, the method comprising: a delivery sheath of a percutaneous positioning delivery device, said delivery sheath carrying said medical implant, detecting electrical impedance between a first electrode and a second electrode, the first electrode and the second electrode being in contact with a patient at spaced-apart locations, and The detected electrical impedance is analyzed to detect changes in tissue at the delivery sheath during percutaneous delivery of the medical implant.

41. The method of claim 40, further comprising comparing the detected electrical impedance to a threshold value.

42. The method of claim 40 or claim 41 further comprising displaying information related to the detected electrical impedance on a graphical user interface.

43. The method of any one of claims 40 to 42, further comprising powering the medical implant within the delivery sheath to test the position of the medical implant prior to fully releasing the medical implant from the delivery sheath.

44. A method of percutaneously delivering a neurostimulator implant into tissue of a patient, the method comprising: percutaneously positioning a delivery sheath carrying the neurostimulator implant; detecting a change in electrical impedance between a first electrode and a second electrode, the first electrode and the second electrode being in contact with a patient at spaced-apart locations, the change in electrical impedance being indicative of a change in patient tissue at the delivery sheath; and Power is supplied to the neurostimulator implant within the delivery sheath to test the position of the neurostimulator implant relative to a nerve of a patient.

45. The method of claim 44, comprising positioning the delivery sheath proximate the nerve based on the detected electrical impedance, and subsequently testing the position of the neurostimulator implant relative to the nerve by powering the neurostimulator implant within the delivery sheath.

46. ​​The method of claim 44 or claim 45, further comprising partially retracting the delivery sheath to expose electrodes of the neurostimulator implant prior to powering the neurostimulator implant within the delivery sheath.

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