Method for percutaneously implanting medical implant and delivery device for percutaneously delivering medical implant

Abstract

A delivery device for percutaneous delivery of a medical implant into tissue of a patient is provided. The delivery device includes a delivery sheath having a lumen adapted to retain a medical implant. The delivery sheath is percutaneously positionable for implanting the medical implant into tissue of a patient. The delivery sheath includes a sidewall having a side opening through which at least a portion of the medical implant is expelled during use.

Description

[0001] The present invention relates to a method of percutaneously implanting a medical implant, and a delivery system for percutaneously delivering a medical implant, such as a neuromodulation implant, into tissue of a patient. 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 method of percutaneously implanting a medical implant into patient tissue, the medical implant comprising a wireless power receiver and an elongated electrode lead, wherein the method comprises percutaneously implanting the medical implant such that the wireless power receiver is oriented toward a skin surface of the patient at the implantation site.

[0004] Therefore, wireless power transmission between a medical implant and a transmitted external wireless power may be improved.

[0005] In an example, the method may include percutaneously implanting a medical implant such that the wireless power receiver is oriented within approximately 20 degrees of normal to the patient's skin surface at the implant site, preferably within approximately 10 degrees of normal to the patient's skin surface at the implant site, and more preferably within approximately 5 degrees of normal to the patient's skin surface at the implant site.

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

[0007] In an example, the wireless power receiver may include an antenna receiver for receiving wireless power through wireless power coupling. In such an example, the antenna receiver may have a power receiving direction, and the medical implant may be implanted percutaneously so that the power receiving direction of the antenna receiver is oriented toward the skin surface of the patient.

[0008] In an example, a medical implant may include a housing having an antenna portion configured to act as a wireless power receiver. The antenna portion may have a power receiving direction, and the medical implant may be implanted percutaneously such that the power receiving direction of the antenna portion of the housing is oriented toward a skin surface of the patient.

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

[0010] In an example, the housing portion may include a wall having a wireless power transmission window for transmitting wireless power through the wall of the housing portion. The method may include percutaneously implanting the medical implant such that the wireless power transmission window is directed toward the patient's skin at the implantation site.

[0011] In an example, the method may include simultaneously percutaneously implanting a housing portion and an electrode lead of a medical implant. In an example, the method may include percutaneously implanting the electrode lead at a greater depth than the housing portion and / or at a different angle. In an example, the electrode lead may be implanted at an angle relative to the housing portion. In an example, the method may include percutaneously implanting the electrode lead near a nerve or target tissue of a patient, and percutaneously implanting the housing portion into subcutaneous tissue of the patient.

[0012] In an example, the method may include sequentially percutaneously implanting an electrode lead and then percutaneously implanting a housing portion of the medical implant. In an example, the method may include percutaneously implanting the electrode lead at a depth greater than the housing portion. In an example, the housing portion may be implanted at an angle relative to the electrode lead. In an example, the method may include percutaneously implanting the electrode lead near a nerve of the patient, and percutaneously implanting the housing portion into subcutaneous tissue of the patient, such as fascia. In an example, the method may include percutaneously implanting the electrode lead, rotating the housing portion relative to the electrode lead, and then percutaneously implanting the housing portion.

[0013] In an example, the medical implant may include an elongated housing portion that holds a wireless power receiver. In such an example, the method may include percutaneously implanting an electrode lead at a non-parallel angle relative to the elongated housing portion. In an example, the method may include percutaneously implanting the elongated housing portion such that the axial direction of the electrode lead is substantially perpendicular to the elongated housing portion. That is, the electrode lead may be angled relative to the housing portion. Thus, the electrode lead may be appropriately positioned in the tissue, and the housing portion (and the wireless power receiver) may be oriented to receive wireless power.

[0014] In an example, the method may include percutaneously implanting the electrode lead while the elongated housing portion is substantially parallel to the electrode lead, and once the electrode lead is implanted, positioning the elongated housing portion so that the wireless power receiver is oriented toward the patient's skin at the implantation site.

[0015] In an example, the method may include rotating the housing portion after implanting the electrode lead. Advantageously, the housing portion rotates without displacing the electrode lead. In an example, the electrode lead is anchored in the patient's tissue, for example, by one or more anti-migration members. In an example, the housing portion is moved toward the patient before rotating to reduce tension in the electrode lead as the housing portion rotates. In an example, during the rotation of the housing portion, a portion of the electrode lead passes through an opening in the delivery sheath, which can prevent the delivery sheath from pulling on the implanted electrode lead as it rotates.

[0016] In an example, the method may include using a delivery device to percutaneously implant a medical implant. The delivery device may include a delivery sheath that holds the medical implant, and the method may include percutaneously positioning the delivery sheath to percutaneously implant the medical implant.

[0017] In an example, a delivery sheath may include a first element for percutaneously implanting a housing portion of a medical implant holding a wireless power receiver, and a second element for percutaneously implanting an electrode lead. The second element of the delivery sheath may be parallel to and extend beyond the first element of the delivery sheath.

[0018] In an example, the second element of the delivery sheath can be retractable relative to the first element of the delivery sheath. The method can include percutaneously positioning the first element of the delivery sheath at a first depth, percutaneously positioning the second element of the delivery sheath at a second depth, retracting the second element of the delivery sheath to implant the electrode lead, and ejecting the housing portion from the first element of the delivery sheath.

[0019] In an example, the method may further include rotating the first element of the delivery sheath to change the angle of the housing portion relative to the electrode lead after retracting the second element of the delivery sheath. In an example, the first element of the delivery sheath is not percutaneously positioned when it is rotated. For example, the first element of the delivery sheath can be withdrawn from the patient's body before rotating.

[0020] In an example, the first element of the delivery sheath can have an axial direction, and the housing portion can be ejected from the first element of the delivery sheath in a direction that is not parallel to the axial direction of the first element of the delivery sheath. For example, the housing portion can be ejected from the first element of the delivery sheath through a side opening in the first element of the delivery sheath. In an example, the housing portion rotates as it is ejected from the first element of the delivery sheath.

[0021] In an example, the delivery device may include a pusher operable to eject the housing portion from the first element of the delivery sheath. The method may include operating the pusher to eject the housing portion from the first element of the delivery sheath.

[0022] In an example, the medical implant may be a neurostimulator implant operable to stimulate a patient's nerves. 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).

[0023] In an example, the medical implant may also include a wireless power transmitter. In an example, the medical implant may be operable as a wireless power repeater for providing wireless power to another medical implant.

[0024] According to a second aspect of the present disclosure, there is also provided a delivery device for percutaneously delivering a medical implant into a patient's tissue, the delivery device comprising: a delivery sheath having an inner lumen adapted to retain a medical implant, the delivery sheath being positionable percutaneously for implanting the medical implant into patient tissue; And wherein the delivery sheath comprises a side wall having a side opening through which at least a portion of the medical implant is expelled during use.

[0025] Advantageously, the side opening allows at least a portion of the medical implant to be expelled in a direction that is not parallel to the delivery sheath, thereby allowing a wireless power receiver of the medical implant to be directed toward the patient's skin.

[0026] In an example, the medical implant includes a housing portion. The medical implant may include only the housing portion (i.e., without electrode leads). In such an example, the housing portion may be ejected through the side opening. The housing portion may be rotated as it is ejected through the side opening, for example using a pusher and / or guide that rotates the housing portion as it is ejected.

[0027] In an example, a medical implant may include a housing portion and an elongated electrode lead extending from the housing portion. In an example, a delivery sheath may include a first element adapted to hold the housing portion and a second element adapted to carry the elongated electrode lead. In some examples, the first element of the delivery sheath may include a side opening. The size of the side opening may be designed to discharge the housing portion during implantation. Thus, the housing portion may be implanted without being parallel to the electrode lead. In other examples, the size of the side opening may be designed to hold the housing portion in the first element of the delivery device and allow a portion of the electrode lead to pass through the side opening. In this way, when the delivery device is rotated during implantation, the electrode lead may pass through the side opening, thereby preventing the electrode lead from being pulled. Thus, this may allow the electrode lead and the housing portion to be implanted at different angles.

[0028] Advantageously, the side opening allows the housing portion to be implanted non-parallel to the electrode lead. In this way, the electrode lead can be implanted to target the patient's nerves or target tissue, and the housing portion can be implanted in an orientation that is conducive to wireless power transmission, wireless communication, and / or in a position that is convenient or comfortable for the patient.

[0029] In an example, the side opening can extend to a tip of the first element of the delivery sheath.In an example, the first element of the delivery sheath includes a slot along one side, the slot including the side opening.

[0030] In an example, the second element of the delivery sheath may be retractable relative to the first element of the delivery sheath for implantation of the elongated electrode lead. In an example, the second element of the delivery sheath may include a slot extending along a side of the second element of the delivery sheath.

[0031] In an example, the delivery device may further include a pusher operable to push a portion of the medical implant through the side opening during use.

[0032] In an example, the delivery device may further include a guide disposed in the delivery sheath and arranged to guide a portion of the medical implant discharged through the side opening during use. In an example, the guide is shaped to rotate the portion of the medical implant as it is discharged through the side opening.

[0033] In examples, the side opening is sized to retain the housing portion within the first element of the delivery sheath and to allow a portion of the elongated electrode lead to pass through the side opening. In examples, the first element of the delivery sheath is sized so that, in use, a portion of the elongated electrode lead can be placed on the housing portion within the first element of the delivery sheath. In examples, a portion of the elongated electrode lead placed on the housing portion within the first element of the delivery sheath is aligned with the side opening in the first element of the delivery sheath.

[0034] In an example, the delivery device further comprises a pusher operable to push the housing portion out of the first element of the delivery device.

[0035] In an example, the delivery sheath may include a needle and / or a cannula.

[0036] According to a third 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 device is provided, the delivery device comprising a delivery sheath, the delivery sheath comprising an inner lumen and a side wall having a side opening, providing a medical implant within the lumen of the delivery sheath, percutaneously positioning the delivery sheath within the patient's tissue, and At least a portion of the medical implant is expelled through the side opening of the delivery sheath.

[0037] Advantageously, the side opening allows at least a portion of the medical implant to be expelled in a direction that is not parallel to the delivery sheath, thereby allowing a wireless power receiver of the medical implant to be directed toward the patient's skin.

[0038] In an example, a medical implant may include a housing portion having a wireless power receiver. The method may include ejecting the housing portion of the medical implant through a side opening of a delivery sheath such that the wireless power receiver is oriented toward the patient's skin at the implantation site.

[0039] In an example, a guide can be used to constrain the position and orientation of a delivery sheath when the delivery sheath is percutaneously positioned. The guide can be adjustable to allow adjustment of the position and orientation of the delivery sheath. In an example, the guide can be part of a delivery device. The guide can be removed from the delivery sheath. The guide can be abutted against or attached to a patient. The guide can include a guide channel through which the delivery sheath passes and which constrains the position and orientation of the delivery sheath. The guide can be configured to target a specific target location within patient tissue, such as a target nerve. The guide, in particular the guide channel and / or a portion of the guide that engages the patient can be adjustable to allow adjustment of the position and orientation of the delivery sheath.

[0040] In an example, the method may include rotating a housing portion of the medical implant as the housing portion of the medical implant is expelled through a side opening in the delivery sheath. In an example, the method may include pushing a housing portion of the medical implant through a side opening in the delivery sheath.

[0041] In an example, the medical implant further comprises an elongated electrode lead. The method may include percutaneously implanting the electrode lead and discharging the housing portion through a side opening of the delivery sheath. Thus, the electrode lead and the housing portion may be implanted non-parallel to each other.

[0042] In an example, a delivery sheath may include a first element having a lumen adapted to hold a housing portion, and a second element extending beyond the first element of the delivery sheath and adapted to carry an elongated electrode lead. The method may include retracting the second element of the delivery sheath to implant the elongated electrode lead.

[0043] In an example, a medical implant may include a housing portion and an elongated electrode lead extending from the housing portion and covering the housing portion within a delivery sheath. In this example, the method may include implanting the electrode lead, rotating the delivery device so that a portion of the electrode lead passes through the side opening, and implanting the housing portion at a different angle than the elongated electrode lead.

[0044] In an example, a delivery sheath can include a first element having an inner cavity adapted to hold a housing portion, and a second element extending beyond the first element of the delivery sheath and adapted to carry an elongated electrode lead. The first element can include a side opening. In this example, the electrode lead can pass through the side opening when the delivery device is rotated. This can help prevent the first element of the delivery sheath from pulling on the electrode lead when it is rotated.

[0045] In an example, the method may include retracting a second element of the delivery sheath to implant an electrode lead, rotating the delivery device, and implanting the housing portion at a different angle to the electrode lead and / or at a different depth in patient tissue.

[0046] In an example, the method may further include pushing the housing portion out of the delivery sheath after rotating the delivery device such that the housing portion is implanted in a different orientation than the electrode lead.

[0047] In an example, the medical implant may be a neurostimulator implant operable to stimulate a patient's nerves. 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). In an example, the medical implant may include a motion sensor or accelerometer to detect patient movement.

[0048] In an example, a medical implant may include a wireless power receiver and a wireless power transmitter.The medical implant may be operable as a wireless power repeater for providing wireless power to another medical implant.

[0049] According to a fourth aspect of the present disclosure, there is provided a medical implant, such as a neurostimulator implant or a diagnostic implant, comprising a housing portion, an electrode lead extending from the housing portion and having one or more electrodes, and an antenna extending from the housing portion.

[0050] In an example, the antenna is flexible. The antenna may include a helical or coil antenna extending within a flexible material or sheath. In an example, the tip of the antenna may be sharp. The antenna may cut through patient tissue when it is deployed. In an example, the antenna is a wireless power receiver antenna and / or a wireless communication antenna. Thus, the antenna may be implanted at different angles or orientations relative to the housing portion of the medical implant. This may allow the antenna to be implanted at a favorable orientation for wireless communication and / or wireless power transfer with an external device.

[0051] In an example, the antenna is one arm of a multipole antenna, such as a dipole antenna. The other arm of the dipole antenna may be arranged in the housing part and / or in the electrode lead.

[0052] According to a fifth aspect of the present disclosure, there is provided a delivery device for percutaneously delivering a medical implant into a patient's tissue, the medical implant comprising an elongated housing portion and a flexible antenna extending from one side of the elongated housing portion, wherein the delivery device comprises: A delivery sheath for percutaneously implanting a medical implant into a patient's tissue, the delivery sheath comprising: an inner cavity adapted to hold said housing portion of said medical implant, a guide channel formed along one side of the delivery sheath for holding the flexible antenna, and A groove extends from the guide passage to the inner cavity.

[0053] In an example, the delivery device may further include a pusher operable to push the housing portion through the lumen of the delivery sheath.

[0054] In an example, the guide channel may include a deflector arranged to deflect the flexible antenna away from the delivery sheath when the medical implant is pushed through the lumen of the delivery sheath.

[0055] In an example, the delivery device may further include a flexible sheath slidably disposed in the guide channel and operable to carry the flexible antenna into lateral deployment. The flexible sheath may partially surround the antenna. The flexible sheath may be deflected by a deflector in the guide channel, or it may have shape memory. The flexible sheath may have a sharp tip for cutting through the patient's tissue when deploying the antenna.

[0056] According to another aspect of the present invention, there is also provided a method for percutaneously implanting a medical implant into a patient's tissue, wherein the medical implant comprises a housing portion and a flexible elongated electrode lead extending from the housing portion, the method comprising: providing a delivery device having a delivery sheath holding a medical implant, The delivery sheath is percutaneously positioned near the patient's target nerve. The long electrode lead is implanted from the delivery sheath so that the long electrode lead is close to the target nerve. rotating the delivery sheath so that the housing portion is not parallel to the elongated electrode lead, and The housing portion is implanted from the delivery sheath such that the housing portion is percutaneously implanted at a different angle than the elongated electrode lead.

[0057] In an example, rotating the delivery sheath can include rotating the delivery sheath toward the patient's skin so that the housing portion is implanted at a smaller angle relative to the skin than the electrode lead. In some examples, the housing portion can be implanted parallel to or substantially parallel to the patient's skin. In some examples, at least a portion of the electrode lead can extend into the patient's tissue away from the skin toward the target nerve, for example at an angle of up to about 45 degrees from a normal on the skin surface.

[0058] In an example, the delivery sheath may include a first needle holding a housing portion and a second needle holding an elongated electrode lead. In such an example, the second needle may be retractable relative to the first needle. The method may include retracting the second needle to implant the electrode lead.

[0059] In an example, the first needle may include a side opening. In such an example, during use, when the delivery sheath is rotated, a portion of the elongated electrode lead may pass through the side opening. This may reduce the pulling force or tension in the electrode lead, helping to prevent the electrode lead from moving from its implanted position.

[0060] In an example, the first needle can be positioned percutaneously when the delivery sheath is rotated. That is, the tip of the first needle can be positioned below the skin when the delivery sheath is rotated. For example, the tip of the first needle can be positioned in subcutaneous tissue, such as fascia, when the delivery sheath is rotated. Advantageously, only one puncture wound is created in the patient's skin.

[0061] In other examples, the first needle is not percutaneously positioned when the delivery sheath is rotated. In an example, in the method, the first needle is percutaneously positioned when the second needle is retracted, and the method further includes withdrawing the first needle to a non-percutaneous position before rotating the delivery sheath, and reinserting the first needle into the patient's tissue before implanting the housing portion. BRIEF DESCRIPTION OF THE DRAWINGS

[0062] Embodiments of the present invention are further described below with reference to the accompanying drawings, in which: Figure 1 A medical implant is shown; Figure 2 The location of a medical implant within a patient's body, particularly in a subcutaneous location, is shown; Figure 3A and Figure 3B Another example medical implant used as a wireless power repeater for another medical implant is shown; Figure 4 shows a schematic cross-section of a delivery sheath of a delivery device for implanting a medical implant into a patient, in particular a first needle and a second needle of the delivery device; FIG. 5A to FIG. 5C shows a schematic cross-section of a delivery device including a handle during implantation of a medical implant; Figure 6 showing a perspective view of the ends of a first needle and a second needle and a medical implant held by the first needle and the second needle; Fig. 7A The second stitch is shown; Figure 7B The first stitch is shown; FIG. 8A to FIG. 8C An exemplary cross section through a second needle and an electrode lead is shown; Fig. 9 An example delivery device is shown wherein the second needle is initially in a retracted position; Fig.10 An example delivery device is shown wherein the tab is moved toward the handle to retract the second needle; Fig.11A showing a medical implant deployed in a first configuration relative to a skin surface; Fig. 11B showing a medical implant deployed in a second configuration relative to a skin surface; Fig.12 A first example of an implant delivery device having a side opening through which a portion of a medical implant may be expelled is shown; Fig.13 showing a housing of a medical implant rotated to a second position; Fig.14 A second example of a delivery device having a side opening is shown; Fig.15 A third example of a delivery device having a side opening is shown; Fig.16 A fourth example of a delivery device having a side opening is shown; Fig.17 A fifth example of a delivery device having a side opening is shown; Fig.18A and Fig.18B Another example of a delivery device having a side opening is shown; FIG. 19A to FIG. 19E Shows the use Fig.18A and Fig.18B delivery devices to implant medical implants; Fig. 20 Example medical implant locations are shown; Fig.21 An alternative medical implant with an external antenna is shown; and FIG. 22A to FIG. 22D Shown for implantation Fig.21 An example delivery device for a medical implant. Detailed Description

[0063] 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, 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.

[0064] As shown, the housing portion includes a wireless power receiver 35. The wireless power receiver 35 may include an antenna receiver (e.g., a coil), or it may include a conductive portion of the housing portion 2. The wireless power receiver 35 is adapted to wirelessly couple with an external device to receive wireless power, as further described below.

[0065] 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.

[0066] 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.

[0067] As further described below, the medical implant 1 can be implanted in a patient, for example, 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 some examples, the medical implant 1 is implantable to sense and / or stimulate the cervical nerve. Stimulating the hypoglossal nerve and / or the cervical 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).

[0068] Figure 2 The medical implant 1 is shown when implanted in a patient. The medical implant 1 is positioned below the skin surface, 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 damage and / or irritation to the patient.

[0069] 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 nerve 9, and thus electrode 4 can be used to sense and / or stimulate nerve 9.

[0070] 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.

[0071] In the example, the medical implant 2 is battery-free and has no integrated power source. The external device 32 may be connected via Figure 1 The wireless power receiver 35 shown in the figure wirelessly powers the medical implant 1. The external device 32 can also wirelessly communicate with the electronic devices in the medical implant 1, especially 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.

[0072] 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 greater occipital nerve.

[0073] In operation, the electrodes 4 of the neurostimulator implant are provided with an electrical signal, such as an electric current, to stimulate the nerves. In an example, the electrical signal may be a voltage-regulated stimulation. This stimulation may provide relief from chronic pain (e.g., occipital neuralgia, intractable migraines) and / or other therapeutic benefits. In various examples, the neurostimulator implant may target specific deep subcortical, cortical, spinal, cranial, and peripheral nerve structures to treat the patient's pain. Neurostimulation is an alternative to painkillers and nerve block injections. It has fewer side effects than many medications and may reduce the likelihood of drug dependence.

[0074] 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 signals. The neural signals can be analyzed for the purpose of detecting, monitoring and / or diagnosing a condition. The neurodiagnostic implant 1 can target the same nerves as described above for the neurostimulator implant 1.

[0075] In other examples, the diagnostic implant may additionally or alternatively detect one or more patient vital signs, such as temperature, heart rate, electromyogram (EMG), electrocardiogram (ECG), respiratory rate, blood pressure, and / or blood gas concentrations (e.g., oxygen, carbon dioxide, carbon monoxide).

[0076] Figure 3A and Figure 3B 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 3A 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 3BIn 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, providing improved wireless power coupling.

[0077] As described above, the medical implant 1 is powered by wireless power transfer (WPT) from the external device 32. The efficiency of WPT depends on the proximity of the medical implant 1 to the wireless power transmitter in the external device 32. The efficiency of WPT is also affected by the orientation of the medical implant relative to the wireless power transmitter, and even slight movement can result in a loss of WPT or a reduction in WPT efficiency.

[0078] In some examples, the medical implant 1 may include an internal battery, and the battery may be recharged by wireless power transfer in the same manner as described above. In this case, the external device 32 may be used to charge the medical implant 1 periodically.

[0079] The description of the wireless power receiver 35 of the medical implant 1 relates to an electrically small antenna, which means that the antenna in this article has a physical size that is smaller than the wavelength of the operating frequency. In view of this, the terms near-field, mid-field and far-field can be considered to be different operating regions depending on the operating frequency and the distance between the transmitter antenna and the receiver antenna. When the distance between the transmitter antenna and the receiver antenna is less than one wavelength of the operating frequency, it can be considered as near-field, when the distance between the transmitter antenna and the receiver antenna is close to or on the boundary of one wavelength of the operating frequency, it can be considered as mid-field, and when the distance between the transmitter antenna and the receiver antenna is greater than one wavelength of the operating frequency, it can be considered as far-field.

[0080] Examples disclosed herein relate to wireless power transfer systems, transmitters, receivers, transmitter antennas, and receiver antennas configured to enable wireless power transfer to power a medical implant and / or recharge a battery forming part of a medical implant.

[0081] The medical implant comprises a wireless power receiver 35 arranged to be wirelessly coupled with a wireless power transmitter of an external device 32. The wireless power transmitter of the external device 32 and the wireless power receiver 35 can be configured to operate in the following frequency bands: Ultra High Frequency Band (UHF), L-Band, S-Band, C-Band and X-Band. This means that the system is adaptable and can operate in the range of 30 MHz to 12 GHz, making the wireless power transmission flexible with respect to the distance between the receiver and the transmitter.

[0082] In one example, the wireless power receiver 35 is configured to receive the transmitted wireless power transmission from the wireless power transmitter at a distance of 1 cm to 10 cm. The system enables wireless power transmission to be performed at this distance, and thus the system can operate in near field, mid field, and far field.

[0083] Figures 4 to 7B A first example implant delivery device 10 is shown. Figure 4 As shown, the implant delivery device 10 includes a delivery sheath. In this example, the delivery sheath includes a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 are parallel 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 bevel tip, and the second needle 13 extends beyond the top 14 of the second needle. The second needle 13 also has a top 15, in particular a bevel tip. The second needle 13 has a higher gauge than the first needle 12, and in particular the second needle 13 has a smaller diameter than the first needle 12.

[0084] During use, the implant housing 2 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 most of the second needle 13 toward the tip 15. A portion of the electrode lead 3 adjacent to the implant housing 2 extends through the opening in the second needle 13, as shown in FIG. Figure 6 Thus, during use, the medical implant 1 is positioned within the first needle 12 and the second needle 13 of the delivery device 10 .

[0085] like Figure 4 As shown, the first needle 12 and the second needle 13 are axially offset. In particular, the center axis of the first needle 12 deviates 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), so that the second needle 13 is partially received in the first needle 12, side by side with the implant housing 2.

[0086] Reference Figure 6The second needle 13 includes a slot 18 to allow a portion of the electrode lead 3 to extend from the second needle 13 and connect to the implant housing 2, as shown in FIG. Figure 4 The slot 18 may extend to the tip 15 of the second needle 13, as further described below.

[0087] In some examples, the second needle 13 may include a sheath having an opening extending completely or substantially along one side.

[0088] As described in further detail below, during use, the first needle 12 and the second needle 13 both penetrate the patient's skin to simultaneously position the implant housing 2 at a first depth and the electrode lead 3 at a second depth within the patient's body. The implant delivery device 10 then releases and deploys the medical implant 1 to leave the medical implant 1 within the patient's body. Figure 2 The top 14 of the first needle 12 and the top 15 of the second needle 13 are sharp tips suitable for piercing the patient's skin and penetrating tissue to 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 and 15 can be beveled tips.

[0089] 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.

[0090] In various examples described below, the second needle 13 can be retracted relative to the first needle 12 to deploy the electrode lead 3. Figure 6 ) allows deployment of electrode lead 3.

[0091] In an example, the implant housing 2 is releasably attached to the first needle 12 (or another portion of the implant delivery device 10) and released prior to deployment.

[0092] In an example, the implant housing 2 may be deployed from the first needle 12 simply 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 implant housing 2 from the first needle 12. In other examples, the implant delivery device 10 may include a deployment member adapted to push the implant housing 2 out of the first needle 12 to deploy the implant housing 2 at an appropriate anatomical site.

[0093] FIG. 5A to FIG. 5C The operation of the delivery device 10 is shown.

[0094] 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.

[0095] 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.

[0096] The second needle 13 can be retracted relative to the first needle 12. In particular, the second needle 13 can slide through the first needle 12 and the handle 11, from Figure 5A The location shown to Figure 5B 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 6 ) is provided for the portion of the electrode lead 3 connected to the housing portion 2. The opening 18 extends to the tip 15 of the second needle 13.

[0097] 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 5B in the extended position shown in .

[0098] exist Figure 5A 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.

[0099] Reference Figure 5A and Figure 2 As the implant delivery device 10 is pushed into the patient's body, the second needle 13 first penetrates the skin 5, and as 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.

[0100] In an example, the operator may use an ultrasound imaging device to monitor the position of the second needle 13 (and the first needle 12 ) to guide the second needle 13 toward the target nerve 9 .

[0101] 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. Figure 5A and Figure 5B In particular, the second needle 13 can be partially retracted to expose the electrode (4, see Figure 1 ) and the position of the electrode can be tested. If necessary, the second needle 13 can be re-extended to Figure 5A position as shown and reposition.

[0102] Once the electrode lead 3 is properly positioned, the second needle 13 is retracted. Figure 5B The position shown is for deploying electrode lead 3.

[0103] 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 5B 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).

[0104] Next, if Figure 5C 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 is sufficient to hold the medical implant 1 in place when the implant delivery device 10 is withdrawn, thereby deploying the housing portion 2 away from the first needle 12 when the implant delivery device 10 is withdrawn from the patient's body.

[0105] In other examples, the implant delivery device 10 may include a deployment member configured to push the housing portion 2 out of the first needle 12 (e.g., a pusher in the first needle 12). In some examples, the implant delivery device 10 may have a retaining member that is 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. In an example, the retaining member may also be electrically coupled to the medical implant 1, in particular the housing portion 2. The electrical coupling may allow the medical implant 1 to be powered while within the delivery device 10.

[0106] In other examples, the medical implant 1 may include one or more anti-migration features. For example, the electrode lead 3 may include one or more anti-migration features adapted to anchor the electrode lead (and the medical implant 1 ) when the second needle 13 is retracted.

[0107] Figure 6 , Fig. 7A and Figure 7B 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.

[0108] 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.

[0109] like Figure 6 As shown, the second needle 13 extends through the inner cavity of the first needle 12. In particular, as Figure 7B 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.

[0110] 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.

[0111] 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.

[0112] 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.

[0113] 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 6 shown.

[0114] 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 in the lumen of the first needle 1 advantageously means that only one puncture wound is formed in the patient's skin, because the first needle 12 will enlarge the puncture wound formed by the second needle 13 during use.

[0115] 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.

[0116] FIG. 8A to FIG. 8C An example of the second needle 13 and the electrode lead 3 is shown, and in particular how the electrode lead 3 is held in the second needle 13 . Second needle 13 . FIG. 8A to FIG. 8C Shown is a cross section through the electrode lead 3 and the second needle 13. As mentioned above, the second needle 13 includes a slot 18 that allows the second needle 13 to be retracted relative to the first needle.

[0117] like Fig. 8A As shown, in the first example, the second needle 13 surrounds more than half of the electrode lead 3. That is, the groove 18 in the second needle 13 extends less than 180 degrees around the circumference of the second needle 13, preferably less than about 160 degrees, preferably between about, less than about 140 degrees. In the example, the groove 18 extends at least 90 degrees around the circumference of the second needle 13. In the example, the groove 18 extends between about 100 degrees and about 150 degrees around the circumference of the second needle 13. Therefore, the electrode lead 3 is maintained in the inner cavity of the second needle 13.

[0118] Preferably, the electrode lead 3 can pass through the slot 18 when being pushed or pulled. The size of the slot 18 is designed to allow the electrode lead 3 to be assembled into the second needle 13 by pressing the electrode lead 3 through the slot 18 relative to the electrode lead 3. The electrode lead 3 and / or the second needle 13 can be deformed to allow the electrode lead 3 to pass through the slot 18.

[0119] like Figure 8B As shown, in some examples, the second needle 13 may include recesses or grooves 308a, 308b in opposite sides of the inner surface of the second needle 13. The electrode lead 3 may include corresponding protrusions or ridges 309a, 309b that engage the grooves 308a, 308b to hold the electrode lead 3 in the second needle 13. The grooves 308a, 308b may extend along the length of the second needle 13 to allow the second needle 13 to slide relative to the electrode lead 3. The ridges 309a, 309b may extend at least partially along the length of the electrode lead 3.

[0120] like Figure 8CAs shown, in some examples, the electrode lead 3 includes protrusions or ridges 310a, 310b extending from the side of the electrode lead 3 and received within the inner diameter of the second needle 13. The ridges 310a, 310b can extend at least partially along the length of the electrode lead 3. The ridges 310a, 310b are thereby used to hold the electrode lead 3 in the inner cavity of the second needle 13. The electrode lead 3 can be removed from the second needle 13 by rotating the electrode lead 3 in the inner cavity of the second needle 13 until one of the ridges 310a, 310b is aligned with the groove 18, thereby allowing the electrode lead 3 to be removed via the groove 18 (e.g., by pulling it out). Similarly, the electrode lead 3 can be inserted into the second needle 13 by aligning one of the ridges 310a, 310b with the groove 18 and pressing the electrode lead 3 through the groove 18.

[0121] In some examples, the electrode lead 3 may include Figure 8B and Figure 8C The ridges 309a, 309b, 310a, 310b shown in FIG. 1 and the second needle may include ridges 309a, 309b, 310a, 310b as shown in FIG. Figure 8B The grooves 308a, 308b of those shown, and the groove 18 can extend about 180 degrees around the circumference of the second needle 13. In this way, the ridges 309a, 309b, 310a, 310b can be used to hold the electrode lead 3 in the second needle 13, and the electrode lead 3 can be easily inserted into / removed from the second needle 13 via the groove 18. In the above example, the second needle 13 is initially in the extended position, and the first needle 12 and the second needle 13 can be positioned in the patient's body at the same time.

[0122] 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.

[0123] 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 configuration shown, 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.

[0124] 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. 5A to FIG. 5C 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 .

[0125] 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.

[0126] 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 ).

[0127] like Fig.10 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. When the actuation tab 16 is pushed toward the handle 11, one end of the second rack portion 30B can engage the housing portion 2 and push it out of the first needle 13. Therefore, the second rack portion 30B can be a deployment member.

[0128] 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 .

[0129] Fig.11A and Fig. 11B The medical implant 1 is shown deployed in respective first and second configurations, wherein the housing is oriented such that the power receiving direction is directed towards the skin surface (ie, epidermis 5 ) and the electrode 3 extends towards the nerve 9 in a direction different from the longitudinal axis 48 of the housing portion 2 .

[0130] For example, if an external device having a wireless power transmitter (32, see Figure 2 ) is placed on the skin at the implantation site, it can most effectively transmit power in a power transmission direction 50, which can be in a direction perpendicular to the skin surface. Fig.11A and Fig. 11B As shown, the electrode lead 3 is typically deployed at a greater depth than the housing portion 2 because the electrode lead 3 needs to be in close proximity to the nerve 9 to be stimulated and the housing portion 2 needs to be closer to the surface for wireless power coupling and is therefore typically implanted in the patient's subcutaneous tissue 7.

[0131] The first configuration shows the housing portion 2 deployed with the longitudinal axis 48 substantially parallel to the external device (32, see Figure 2 ), which is typically a normal axis relative to the skin surface at the implantation site. The second configuration shows the housing portion 2 deployed with the longitudinal axis 48 at an acute angle relative to the power transmission direction 50 (e.g., the normal axis) at the implantation site.

[0132] The wireless power receiver of the medical implant 1 can have a power receiving direction that is the direction of the wireless power receiver in which wireless power is most efficiently transmitted. Assuming that the power receiving direction is perpendicular to the longitudinal axis 48 of the housing portion 2, the second configuration will exhibit less power loss than the first configuration because the angle between the power receiving direction and the power transmitting direction 50 in the second configuration is less than the angle in the first configuration (where the power receiving direction will be approximately 90 degrees relative to the power transmitting direction). The smaller angle between the power receiving direction and the power transmitting direction 50 in the second configuration corresponds to more efficient power coupling between the wireless power receiver and the wireless power transmitter in the second configuration compared to the first configuration.

[0133] In the illustrated example, where the housing part 2 is arranged such that the longitudinal axis 48 of the housing part 2 is parallel to the skin surface, ie the power receiving direction is parallel to the power transmitting direction, this will provide particularly efficient power coupling.

[0134] In various examples, such as Figure 2 , Fig.11A and Fig. 11B As shown, the electrode lead 3 is implanted at a certain angle relative to the skin 5, which may be necessary to avoid anatomical features or simply to reach the desired implantation site. However, this angle of the electrode lead 3 may not correspond to the housing portion 2 (and the wireless power receiver 35, see Figure 1 ) relative to the external device (32, see Figure 2) and the effective orientation of the wireless power transmitter. Therefore, as described in various ways below, the operator can implant the electrode lead 3 and the housing portion 2 at different angles and make the wireless power receiver (35, see Figure 1 ) is directed towards the skin 5 and thus also towards the external device (32, see Figure 2 ).

[0135] Use the above Figures 1 to 10 With the delivery device shown, an operator is able to deploy the medical implant 1 with the shell portion 2 angled relative to the electrode lead 3 by retracting the second needle 13 (which initially contains the electrode lead 3), rotating the delivery device 10 so that the shell portion 2 is oriented in a desired orientation relative to the skin surface, and deploying the shell portion 2 from the delivery device 10, for example using a pusher 40 as described above.

[0136] In some examples, the electrode lead 3 is implanted so that it extends into the patient's tissue and is particularly close to the target nerve. The housing portion 2 can be implanted at different angles relative to the electrode lead 3. Figures 1 to 3B As shown, the housing portion 2 can be elongated, and the housing portion 2 can be implanted so that it extends generally parallel to the surface of the patient's skin 5. In other examples, the elongated housing portion 2 can be generally perpendicular to the surface of the skin 5.

[0137] Figures 12 to 19E Another example delivery device 100, 200 is shown that is capable of deploying a medical implant 1 such that the housing portion 2 is oriented at an angle relative to the electrode lead 3. Figures 1 to 10 One or more of the structural components described in the delivery device 10 shown in FIG. Figures 12 to 19E In any of the delivery devices 100, 200 shown in .

[0138] Fig.12 An example of a delivery device 100 is shown, which can be used as described above with respect to Figures 1 to 10 The delivery device 10 shown in FIG. 1 is an alternative way of deploying the medical implant 1 to the way described.

[0139] Fig.12 The delivery device 100 includes a handle 11 and a delivery sheath. In this example, the delivery sheath has a first element and a second element, in particular a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 in the delivery device 100 are constructed in substantially the same manner as described above, and the specific features of the first needle 12 and the second needle 13 will not be repeated here. Fig.12The first needle 12 shown includes a side wall 42 having a side opening 44 formed therein. The side opening 44 can extend to the top of the first needle 12 and, in some examples, can extend along the length of the first needle 12. The side opening 44 allows a portion or all of the medical implant 1 to be ejected through the side opening 44 in a direction that is not parallel to the axial direction of the needle 12, as described below. Obviously, similar side openings 44 can be provided above with respect to Figures 1 to 10 An example implant delivery device 10 is described.

[0140] exist Fig.12 In the example shown, the delivery device 100 includes a deployment member (e.g., including a pusher 40) arranged to push the housing portion 2 of the medical implant 1 out of the first needle 12 through the side opening 44 in the side wall 42. The deployment member can be deployed in the manner described above. When the pusher 40 initially contacts the housing portion 2, the housing portion 2 is arranged along the axial direction of the first needle 12. When the pusher 40 pushes against the housing portion 2, the housing portion 2 rotates relative to the first needle 12, for example, rotates to a perpendicular angle relative to the first needle 12, such as Fig.12 and Fig.13 The first needle 12 may include one or more guides 46 or pivot points to facilitate rotation of the housing portion 2 .

[0141] Additionally or alternatively, the pusher 40 itself may be adapted to facilitate rotation of the housing part 2, for example by including an end with a tapered cross section. This allows the pusher 40 to also act as a wedge to rotate the housing part 2 in a predetermined direction (eg, towards the side opening 44).

[0142] As the pusher 40 continues to push against the housing portion 2, eventually, the housing portion 2 is ejected from the first needle 12. The second needle 12 can then be retracted to deploy the electrode lead 3 as described above. Obviously, the physician can rotate the delivery device 100 after the second needle 13 is retracted but before the housing portion 2 is ejected from the first needle 12 to orient the housing portion 2 in the desired orientation. Therefore, the delivery device itself does not need to rotate the housing portion 2 to the final orientation before it is ejected from the first needle 12.

[0143] Fig.13The housing portion 2 is shown in a rotated position relative to the axial direction of the first needle 12. In some examples, the housing portion 2 includes a wireless power receiver having an antenna receiver configured to receive power in a power receiving direction. The power receiving direction can be perpendicular to the longitudinal axis 48 of the housing portion 2. A separate antenna receiver is not required because, in some cases, the housing portion 2 itself can be formed as a power receiver with a power receiving direction. In particular, the housing of the housing portion 2 can be conductive and arranged to function as a power antenna receiver. In some examples, power can be wirelessly transmitted to components within the housing portion 2 through a wireless power transmission window formed in the housing portion 2. When the wireless power transmission window is present, the housing portion 2 is preferably deployed so that the wireless power transmission window is directed toward the patient's skin at the implantation site.

[0144] Since when the power receiving direction is aligned with the external device (32, see Figure 2 ) in order to reduce power losses associated with wireless power coupling when the power transmission direction of the housing 2 is misaligned, it is desirable to be able to deploy the medical implant 1 with the shell portion 2 oriented in a direction different from that of the electrode lead 3.

[0145] Fig.14 A second example of a delivery device 100 having a side opening 44 is shown. Fig.14 The delivery device 100 shown is Fig.12 The delivery device 100 shown is different because the delivery sheath includes a cannula 50 instead of the first needle 12 and the second needle 13. The medical implants 2, 3 are housed in the cannula 50, which is percutaneously positioned during implantation. Once the cannula 50 has been percutaneously positioned, the pusher 40 pushes the medical implants 2, 3 out of the cannula 50. As the pusher 40 pushes the medical implants 2, 3 out of the cannula 50, the cannula 50 can be withdrawn simultaneously.

[0146] The sleeve 50 includes a side wall 52 having a side opening 44 formed therein to allow the housing portion 2 to be opened with reference to the top. Fig.12 and Fig.13The side opening 44 preferably extends to the top of the sleeve 50 and allows the electrode lead 3 to pass therethrough. In some examples, the side opening 44 may extend along the length of the sleeve 50. It will be apparent that the side opening 44 may have different widths along the length of the sleeve 50. For example, the width of the side opening 44 may be larger at the proximal section of the sleeve 50 where the housing portion 2 is required to be received, while the opening may be smaller at the distal section where the electrode lead 3 is required to be received. Therefore, when the sleeve 50 is retracted, the electrode lead 3 can be deployed, and when the pusher 40 is pushed, the housing portion 2 can be discharged through the side opening 44, with the power receiving direction oriented toward the skin surface. The illustrated sleeve 50 includes one or more guides 46 or pivot points that facilitate rotation of the housing portion 2. Fig.12 As in the example of FIG. 1 , the pusher 40 is also shaped to facilitate the rotation of the housing portion 2, and the above description of the pusher 40 is also applicable to the Fig.14 .

[0147] Fig.15 A third example of a delivery device 100 having a side opening 44 is shown. Fig.15 The delivery device 100 shown is Fig.12 The delivery device 100 shown is different in that the delivery sheath includes a single needle 12. The needle 12 has a Fig.13 The cannula 50 of the delivery device 100 shown has substantially the same features, and the description provided above regarding those features also applies to the Fig.15 The delivery device 100 is shown. Fig.15 The example needle 12 may have a beveled tip, allowing the needle 12 to penetrate the patient's skin and tissue without requiring an incision.

[0148] Fig.16 A fourth example of a delivery device 100 having a side opening 44 is shown. Fig.16 The delivery device 100 shown has a delivery sheath formed by a first portion 47 and a second portion 48. The first portion 47 is sized to accommodate the housing portion 2, and the second portion 48 extends from and is secured to the first portion 47. The first portion 47 includes a side opening 44. The side opening 44 can extend to the junction of the first portion 47 and the second portion 48, and in some examples can extend along the length of the first portion 47. The side opening 44 can extend into the second segment 48 and optionally to the top of the second segment 48. The second portion 48 has a smaller diameter than the first portion 47 and holds the electrode lead 3. A tapered segment 49 connects the first portion 47 and the second portion 48. The tapered segment 49 can be shaped to guide the housing portion 2 out of the side opening 44 in the first portion 47. The tapered segment 49 in the delivery sheath advantageously causes the housing 2 to rotate as it slides out of the side opening 44 when the housing 2 is pressed by the pusher 40. As described in reference Fig.13 and Fig.14 The guide 46 described may additionally be provided to guide and rotate the housing portion 2 as previously described. In some cases, the guide 46 may be omitted.

[0149] Fig.17 A fifth example of a delivery device 100 having a side opening 44 is shown. In this example, the delivery device 100 has a delivery sheath having a first needle 12 and a second needle 13, the second needle 13 being arranged in a manner similar to that of the reference Figures 4 to 10 The same manner is movable relative to the first needle 12, in particular, extendable and retractable. In this example, the second needle 13 is initially retracted relative to the first needle 12 so that the first needle pierces the skin to deploy the housing portion 2 before the electrode 3 is deployed. As described above, the housing 2 is deployed via the pusher 40. Once the housing portion 2 is deployed in the desired orientation, the second needle 13 can be extended to position the electrode lead 3 near the nerve 9. The opening formed in the second needle 13 as described above allows the electrode lead 3 to pass through the second needle 13 when the second needle 13 extends deeper into the tissue toward the nerve 9. The side opening 44 in the side wall of the first needle 12 can also extend to the distal tip of the first needle 12, although this is not required. The side opening 44 can extend along the length of the first needle 12. Once the electrode lead 3 is in place, the second needle 13 can be withdrawn to deploy the electrode lead 3.

[0150] Fig.18A and Fig.18B Another example of a delivery device 200 is shown. In this example, the delivery device 200 has a handle 11 and a delivery sheath. In this example, the delivery sheath has a first element and a second element, in particular a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 in the delivery device 200 are similar to those described above. Fig.10 Constructed in essentially the same manner as described.

[0151] In particular, the delivery device 200 includes a device similar to that of reference Fig.10The rack and pinion transmission mechanism described herein 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. When the actuation tab 16 is pushed toward the handle 11, one end of the second rack portion 30B can engage the housing portion 2 and push it out of the first needle 13. Therefore, the second rack portion 30B can be a deployment member.

[0152] Advantageously, pushing the actuation tab 16 rather than pulling the actuation tab 16 may allow for single-handed operation of the implant delivery device 200 .

[0153] like Fig.18A and Fig.18B 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.

[0154] The first needle 12 includes a side opening 12a. Fig.18B The side opening 12a extends from the top end 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. In this example, the side opening 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, and the electrode lead 3 can pass through the side opening 12a, as described below.

[0155] FIG. 19A to FIG. 19E Shows Fig.18A and Fig.18B The operation of implanting the medical implant 1 into the patient's tissue is performed by the delivery device 200.

[0156] Prior to use, the delivery device 200 is Fig.18A and Fig.18B1, wherein the housing portion 2 is positioned in the first needle 12, and the electrode lead 3 extends from the housing portion 2 toward the handle 11, over the housing portion 2 within the first needle 12, and then into the second needle 13. The second needle 13 is in an extended position. In this configuration, the second needle 13 is positioned in a manner similar to the reference needle 11. Figure 5A The same manner as described above is used to position the electrode lead 3 percutaneously so that the electrode lead 3 is appropriately positioned relative to the patient's target nerve. For example, the second needle 13 (and the electrode lead 3) can be close to the target nerve or in contact with the target nerve. An ultrasound imaging device can be used to help guide the second needle 13 to the correct position.

[0157] In some examples, a guide (not shown) may be used to constrain the position and orientation of the second needle 13 during insertion into the patient. The guide may abut or be attached to the patient and have a guide channel through which the second needle 13 passes.

[0158] like Fig.19A As shown, once the second needle 13 is properly positioned, the actuation tab 16 can be pushed to retract the second needle 13 relative to the first needle 12. This exposes and implants the electrode lead 3.

[0159] In some examples, the second needle 13 can be partially retracted to expose the electrode on the electrode lead 3 (4, see Figure 1 ). The position of the electrode can then be tested to verify that the electrode lead 3 is correctly positioned. If necessary, the second needle 13 can be re-extended and repositioned. During such testing, the medical implant 1 can be powered while it is within the delivery device 10, for example by providing a power delivery system in the delivery device 10. The power delivery system can include one or more contacts electrically coupled to the medical implant 1, and / or a wireless power transmitter within the delivery device 10 for powering the medical implant 1.

[0160] Alternatively, if Fig.19B As shown, once the second needle 13 has been retracted, the delivery device 200 is partially retracted from the patient's body. As shown, this partially extends the electrode lead 3. This partial retraction can make it easier to move (i.e., rotate) the first needle 12, as described below.

[0161] from Fig.19B In the position shown, the delivery device 200 can be rotated relative to the patient to change the orientation of the first needle 12 and the housing portion 2 relative to the implanted portion of the electrode lead 3, such as Fig.19C and Fig.19D As shown. Fig.19C and Fig.19D As shown, when the delivery device 200 rotates, the electrode lead 3 passes through the side opening 12a in the first needle 12. The electrode lead 3 can be bent when the first needle 12 rotates, as shown in FIG. Fig.19DThe side opening 12a can thereby reduce the tension in the electrode lead 3, or reduce the pulling of the electrode lead 3 by the first needle 12 when the first needle 12 rotates, which helps to ensure that the electrode lead 3 remains in the implanted position.

[0162] If a guide is used as described above, it may be removed prior to rotating the conveyor 200 .

[0163] like Fig.19D As shown, the electrode lead 3 may include one or more anti-migration features 60, such as spring barbs. The anti-migration feature can be deployed when the second needle 13 is retracted, and is used to keep one end of the electrode lead 3 in a proper position relative to the nerve. Therefore, the end of the electrode lead 3 with the electrode 4 is relatively fixed in the tissue, and the rest of the electrode lead 3 (and the housing portion 2) can be moved (e.g., rotated) as described above without changing the position of the electrode 4 relative to the nerve.

[0164] from Fig.19C and Fig.19D In the position shown, the housing portion 2 can be deployed into the patient's tissue from the first needle 13 at a different angle than one end of the electrode lead 3. Thus, when implanted, the orientation of the housing portion 2 can be different from the orientation of the electrode lead 3. 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 within the anatomy of the implant site.

[0165] Reference below Fig. 20 In one example further described, the housing portion 2 can be implanted (or primarily implanted) in subcutaneous tissue, particularly fascia. The housing portion 2 can be implanted so that it is roughly parallel to the skin surface, while the electrode lead 3 extends deeper into the tissue to a position close to the target nerve. The housing portion 2 can be elongated, such as cylindrical, and its longitudinal axis can be parallel to the surface of the skin when implanted.

[0166] To deploy the housing portion 2 from the first needle 13, the actuation tab 16 may be pushed fully toward the handle 11 so that the second rack portion 30B pushes the housing portion 2 out of the first needle 13. Alternatively, a different deployment member may be used.

[0167] like Fig.19EAs shown, before deploying the housing portion 2, the second needle 13 can optionally be at least partially redeployed (pushed outward) to form an opening in the tissue to accommodate the housing portion 2, or to facilitate placement of the housing portion 2 in the patient's tissue. This can be achieved by pulling the actuation tab 16 away from the handle 11. With or without redeploying the second needle 13, the delivery device 200 and in particular the first needle 12 can be further pushed into the patient's tissue before deploying the housing portion 2, for example to achieve a desired implantation depth or position of the housing portion 2, such as in the subcutaneous tissue (e.g., fascia). The delivery device 200 is preferably rotated so that the first needle 12 is as parallel to the skin surface as possible, thereby allowing the housing portion 2 to be implanted as parallel to the skin surface as possible.

[0168] To deploy and implant the housing portion 2, the actuation tab 16 may be pushed toward the handle 11 so that the second needle 13 is fully retracted and the second rack portion 30B pushes the housing portion 2 out of the first needle 12. The delivery device 200 may then be removed from the patient.

[0169] Fig. 20 An example implant location of a medical implant in a patient's tissue to target a nerve 9 is shown. FIG. 18A to FIG. 19E The implant device and process described in detail in Fig. 20 The implantation position shown in . As shown, the electrode lead 3 is implanted proximal to the nerve 9, and the housing portion 2 is implanted in the subcutaneous tissue 7. The housing portion 2 is implanted approximately parallel to the skin 5, and the electrode lead 3 is bent to extend at different angles relative to the housing portion 2. In this way, the electrode lead 3 is implanted proximal to the nerve 9, and the housing portion 2 is implanted in the subcutaneous tissue in an orientation that may be conducive to wireless power transmission, wireless communication, and / or comfortably mounting the medical implant in the patient's body.

[0170] Fig.21 Another example medical implant 1 is shown. In an example, the medical implant 1 can be a neurostimulator implant or a diagnostic implant. As described above, 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 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.

[0171] As shown, in this example, the medical implant 1 also includes an external antenna 300 extending from the housing portion 2. The external antenna 300 extends from one side of the housing portion 2, in this example near one end from which the electrode lead 3 extends. The external antenna 300 can be a wireless communication antenna and / or a wireless power receiving antenna. The external antenna 300 is flexible and is formed by a flexible body with a coiled antenna member inside the flexible body. As shown, the flexible antenna 300 is attached to the housing portion 2 by an axis 301 extending perpendicular to the housing portion 2.

[0172] when Fig.21 When the medical implant 1 is implanted in a patient, the external antenna 300 can be at different angles and orientations relative to the housing portion 2 and the electrode lead 3. This can advantageously improve wireless communication and / or wireless power transmission using the external antenna 300, because the external antenna 300 can be better oriented to enable an external (e.g., wearable) device to communicate wirelessly with the medical implant 1 and / or provide wireless power transmission for the medical implant 1. For example, the external antenna 300 can be positioned approximately parallel to the patient's skin surface, and thereby can be approximately parallel to a wireless communication and / or wireless power device (e.g., as a wearable device) disposed on the skin surface.

[0173] FIG. 22A to FIG. 22D Shown for implantation Fig.21 The delivery device 302 of the medical implant 1 shown in FIG. In this example, the delivery device 302 has a handle 11 and a delivery sheath. In this example, the delivery sheath has a first element and a second element, in particular a first needle 12 and a second needle 13. The first needle 12 and the second needle 13 in the delivery device 302 are similar to those described above. FIG. 18A to FIG. 1 8E is constructed in a substantially similar manner. In particular, the conveyor 302 includes a rack and pinion transmission mechanism. In other examples, the conveyor 302 can be similar to the reference Figures 4 to 10 or Fig.12 and Fig.13 The conveying devices 1 described are essentially identical.

[0174] like Fig.22A and Fig. 22B As shown, the first needle 12 of the delivery device 302 includes a groove 303 to receive Fig.21 The shaft 301 of the medical implant 1 is shown. The groove 303 extends from the distal tip 16 of the first needle 12 toward the handle 11. Fig. 22B As best shown in FIG. 3 , the shaft 301 extends from the housing part 2 through the slot 303 into the interior of the first needle 12. The external antenna 300 extends from one end of the shaft 301.

[0175] As shown, the first pin 12 includes a guide channel 304 extending along one side of the first pin 12, and the slot 303 is within the guide channel 304. The guide channel 304 is provided by two protrusions 305a, 305b extending from the first pin 12. Therefore, the guide channel 304 can accommodate the external antenna 300 and hold it in a position extending side by side with the first pin 12.

[0176] like Fig. 22C As shown, one or more deflectors 306 are provided in the guide channel 304. Thus, when the housing portion 2 is pushed along the first needle 12 to deploy it, the outer antenna 300, which is initially parallel to the first needle 12, is deflected by the deflector 306. Fig.22A and Fig. 22B As shown, the outer antenna 300 is deflected out of the guide channel 304 substantially perpendicularly to the direction of the first needle 12 .

[0177] One end of the external antenna 300 can be a sharp tip for cutting a path through tissue when the external antenna is pushed outward. In this way, when the housing portion 2 is deployed in a first orientation parallel to the first needle 12, the external antenna 300 is deployed laterally from the housing portion 2.

[0178] In another example, if Fig.22D As shown, the delivery device 302 may include a flexible sheath 307 located within the guide channel 304. The flexible sheath 307 partially surrounds the external antenna 300 and is movable relative to the first needle 12, for example, slidable within the guide channel 304, so that it carries the external antenna 300 to the first needle 12. Fig.22D In the lateral deployment shown. In examples, the flexible sheath 307 can be deflected by the deflector 306 as described above. In other examples, the flexible sheath 307 can include a Fig.22D The shape memory material is biased in the deployed position shown in FIG. 304 so that when the flexible sheath is pushed forwardly out of one end of the guide channel 304 , the flexible sheath moves laterally and carries the external antenna 300 into the lateral deployed position shown.

[0179] 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.

[0180] 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 delivering a medical implant into a patient's tissue, the delivery device comprising: - a delivery sheath having an inner lumen adapted to hold the medical implant, the delivery sheath being positionable percutaneously for implanting the medical implant into patient tissue; And wherein the delivery sheath comprises a side wall having a side opening through which at least a portion of the medical implant is expelled during use.

2. The conveying device according to claim 1, wherein: The medical implant comprises a shell portion and an elongated electrode lead extending from the shell portion, and wherein the delivery sheath comprises a first element adapted to retain the shell portion and a second element adapted to carry the elongated electrode lead, and wherein the first element of the delivery sheath comprises the side opening.

3. The conveying device according to claim 2, wherein: The side opening is sized for expelling the housing portion during implantation.

4. The delivery device of claim 3, further comprising a pusher operable to push the housing portion through the side opening during use.

5. A delivery device according to claim 3 or claim 4, further comprising a guide disposed in the delivery sheath and arranged to guide the housing portion of the medical implant that is expelled through the side opening during use.

6. The conveying device according to claim 5, wherein: The guide is shaped to rotate the housing portion as the housing portion is ejected through the side opening.

7. The conveying device according to claim 2, wherein: The side opening is sized to retain the housing portion within the first element of the delivery sheath and to allow a portion of the elongated electrode lead to pass through the side opening.

8. The conveying device according to claim 7, wherein: The first element of the delivery sheath is shaped so that, in use, a portion of the elongate electrode lead can be placed on the housing portion within the first element of the delivery sheath.

9. The conveying device according to claim 8, wherein: The portion of the elongated electrode lead on the housing portion that is placed within the first element of the delivery sheath is aligned with the side opening in the first element of the delivery sheath.

10. A delivery device according to any one of claims 7 to 9, further comprising a pusher operable to push the housing portion out of the first element of the delivery device.

11. The delivery device according to any one of claims 2 to 10, wherein: The second element of the delivery sheath is retractable relative to the first element of the delivery sheath for implantation of the elongated electrode lead.

12. The delivery device according to any one of claims 2 to 11, wherein: The second element of the delivery sheath includes a groove extending along a side of the second element of the delivery sheath.

13. A delivery device according to any preceding claim, wherein: The delivery sheath includes a needle and / or a cannula.

14. A medical implant, such as a neurostimulator implant or a diagnostic implant, comprising a housing portion, an electrode lead extending from the housing portion and having one or more electrodes, and an antenna extending from the housing portion.

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

16. The medical implant of claim 14 or claim 15, wherein: The top of the antenna is sharp.

17. The medical implant according to any one of claims 14 to 16, wherein The antenna is a wireless power receiver antenna and / or a wireless communication antenna.

18. A delivery device for percutaneously delivering a medical implant into a patient's tissue, the medical implant comprising an elongated housing portion and a flexible antenna extending from one side of the elongated housing portion, wherein the delivery device comprises: - a delivery sheath for percutaneously implanting the medical implant into a patient's tissue, the delivery sheath comprising: - an inner cavity adapted to hold the housing part of the medical implant, - a guide channel formed along one side of the delivery sheath for holding the flexible antenna, and - a groove extending from the guide channel to the inner cavity.

19. The delivery device of claim 18, further comprising a pusher operable to push the housing portion through the lumen of the delivery sheath.

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

21. The delivery device of any one of claims 18 to 20, further comprising a flexible sheath slidably disposed in the guide channel and operable to carry the flexible antenna into a lateral deployment.

22. A method of percutaneously implanting a medical implant into patient tissue, the medical implant comprising a wireless power receiver and an elongated electrode lead, wherein the method comprises percutaneously implanting the medical implant such that the wireless power receiver is oriented toward the patient's skin surface at the implantation site.

23. The method according to claim 22 includes percutaneously implanting the medical implant so that the wireless power receiver is oriented within approximately 20 degrees of the normal to the patient's skin surface at the implantation site, preferably within approximately 10 degrees of the normal to the patient's skin surface at the implantation site, and more preferably within approximately 5 degrees of the normal to the patient's skin surface at the implantation site.

24. The method of claim 22, comprising percutaneously implanting the medical implant such that the wireless power receiver is oriented substantially parallel to a normal to a patient's skin surface at the implantation site.

25. The method according to any one of claims 22 to 24, wherein: The wireless power receiver comprises an antenna receiver for receiving wireless power by wireless power coupling, the antenna receiver having a power receiving direction, and wherein the medical implant is percutaneously implanted such that the power receiving direction of the antenna receiver is oriented toward a skin surface of the patient.

26. The method according to any one of claims 22 to 25, wherein: The medical implant includes an elongated housing portion holding the wireless power receiver, and wherein the wireless power receiver is oriented substantially perpendicular to the elongated housing portion.

27. The method of claim 26, comprising percutaneously implanting the medical implant such that the housing portion is substantially parallel to a patient's skin surface at the implantation site.

28. A method according to claim 26 or claim 27, wherein: The shell portion includes a wall having a wireless power transmission window for transmitting wireless power through the wall of the shell portion, and wherein the method includes percutaneously implanting the medical implant so that the wireless power transmission window is directed toward the patient's skin at the implantation site.

29. A method according to any one of claims 26 to 28, comprising simultaneously percutaneously implanting the housing portion and the electrode lead.

30. A method according to any one of claims 26 to 29, comprising percutaneously implanting the electrode lead at a greater depth than the housing portion and / or at a different angle to the housing portion.

31. The method of any one of claims 26 to 30, comprising percutaneously implanting the electrode lead in the vicinity of a nerve or target tissue of a patient, and percutaneously implanting the housing portion into subcutaneous tissue of the patient.

32. The method according to any one of claims 22 to 31, wherein: The medical implant includes an elongated housing portion holding the wireless power receiver, and wherein the method includes percutaneously implanting the electrode lead at a non-parallel angle relative to the elongated housing portion.

33. The method of claim 32, comprising percutaneously implanting the elongated housing portion such that an axial direction of the electrode lead is generally perpendicular to the elongated housing portion.

34. The method of claim 32 or claim 33, comprising percutaneously implanting the electrode lead while the elongated shell portion is substantially parallel to the electrode lead, and once the electrode lead is implanted, positioning the elongated shell portion so that the wireless power receiver is oriented toward the patient's skin at the implantation site.

35. The method of claim 34, comprising rotating the housing portion after implanting the electrode lead.

36. The method of any one of claims 22 to 35, comprising using a delivery device to percutaneously implant the medical implant, wherein the delivery device comprises a delivery sheath retaining the medical implant, the method comprising percutaneously positioning the delivery sheath to percutaneously implant the medical implant.

37. The method of claim 36, wherein: The delivery sheath comprises a first element and a second element, wherein the first element is used for percutaneously implanting a shell portion of the medical implant holding the wireless power receiver, the second element is used for percutaneously implanting the electrode lead, and wherein the second element of the delivery sheath is parallel to the first element of the delivery sheath and extends beyond the first element of the delivery sheath.

38. The method of claim 37, wherein: The second element of the delivery sheath is retractable relative to the first element of the delivery sheath, and wherein the method includes percutaneously positioning the first element of the delivery sheath at a first depth, percutaneously positioning the second element of the delivery sheath at a second depth, retracting the second element of the delivery sheath to implant the electrode lead, and ejecting the shell portion from the first element of the delivery sheath.

39. The method of claim 38, further comprising rotating the first element of the delivery sheath to change an angle of the housing portion relative to the electrode lead after retracting the second element of the delivery sheath.

40. The method of claim 38 or claim 39, wherein: The first element of the delivery sheath has an axial direction, and wherein the housing portion is ejected from the first element of the delivery sheath in a direction that is non-parallel to the axial direction of the first element of the delivery sheath.

41. The method of claim 40, wherein: The housing portion is ejected from the first element of the delivery sheath through a side opening in the first element of the delivery sheath.

42. The method according to any one of claims 38 to 41, wherein: The housing portion rotates as it is ejected from the first element of the delivery sheath.

43. A method according to any one of claims 38 to 42, wherein: The delivery device comprises a pusher operable to eject the housing portion from the first element of the delivery sheath, and wherein the method comprises operating the pusher to eject the housing portion from the first element of the delivery sheath.

44. The method according to any one of claims 22 to 43, wherein: The medical implant comprises a neurostimulator implant or a diagnostic implant.

45. The method according to any one of claims 22 to 44, wherein: The medical implant further comprises a wireless power transmitter, and wherein the medical implant is operable as a wireless power repeater for providing wireless power to another medical implant.

46. ​​A method of percutaneously implanting a medical implant into tissue of a patient, the method comprising: - providing a delivery device comprising a delivery sheath comprising an inner lumen and a side wall having a side opening, - providing a medical implant into the lumen of the delivery sheath, - percutaneously positioning the delivery sheath in the patient's tissue, and - Expelling at least a portion of the medical implant through the side opening of the delivery sheath.

47. The method of claim 46, wherein: The medical implant includes a housing portion having a wireless power receiver, and wherein the method includes expelling the housing portion of the medical implant through the side opening of the delivery sheath such that the wireless power receiver is oriented toward the patient's skin at the implantation site.

48. The method of claim 46, comprising rotating the housing portion of the medical implant as the housing portion of the medical implant is expelled through the side opening in the delivery sheath.

49. The method of claim 47 or claim 48, comprising pushing the housing portion of the medical implant through the side opening in the delivery sheath.

50. The method according to any one of claims 47 to 49, wherein: The medical implant also includes an elongated electrode lead, and wherein the method includes percutaneously implanting the electrode lead and expelling the housing portion through the side opening of the delivery sheath.

51. The method of claim 50, wherein: The delivery sheath comprises a first element and a second element, the first element having an inner cavity adapted to hold the shell portion, the second element extending beyond the first element of the delivery sheath and adapted to carry the elongated electrode lead, and wherein the method comprises retracting the second element of the delivery sheath to implant the elongated electrode lead.

52. The method of claim 46, wherein: The medical implant includes a shell portion and an elongated electrode lead, wherein the elongated electrode lead extends from the shell portion and is placed on the shell portion within the delivery sheath, and wherein the method includes implanting the electrode lead, rotating the delivery device so that a portion of the electrode lead passes through the side opening, and implanting the shell portion at a different angle than the elongated electrode lead.

53. The method of claim 52, wherein: The delivery sheath comprises a first element and a second element, wherein the first element has an inner cavity suitable for holding the shell portion, the second element extends beyond the first element of the delivery sheath and is suitable for carrying the elongated electrode lead, the first element includes the side opening, and wherein the electrode lead passes through the side opening as the delivery device rotates.

54. The method of claim 53, comprising retracting the second element of the delivery sheath to implant the electrode lead.

55. The method according to any one of claims 52 to 54, wherein: The method further includes pushing the housing portion out of the delivery sheath after rotating the delivery device.

56. The method according to any one of claims 46 to 55, wherein: The medical implant comprises a neurostimulator implant or a diagnostic implant.

57. The method according to any one of claims 46 to 56, wherein: The medical implant comprises a wireless power receiver and a wireless power transmitter, and wherein the medical implant is operable as a wireless power repeater for providing wireless power to another medical implant.

58. A method of percutaneously implanting a medical implant into tissue of a patient, wherein the medical implant comprises a housing portion and a flexible elongated electrode lead extending from the housing portion, the method comprising: providing a delivery device having a delivery sheath holding the medical implant, percutaneously positioning the delivery sheath proximate a target nerve in a patient, implanting the elongated electrode lead from the delivery sheath so that the elongated electrode lead is close to a target nerve, rotating the delivery sheath so that the housing portion is not parallel to the elongated electrode lead, and The housing portion is implanted from the delivery sheath such that the housing portion is percutaneously implanted at a different angle than the elongated electrode lead.

59. The method of claim 58, wherein: Rotating the delivery sheath includes rotating the delivery sheath toward the patient's skin such that the housing portion is implanted at a smaller angle relative to the skin than the electrode lead.

60. The method of claim 59, wherein: The delivery sheath includes a first needle holding the housing portion and a second needle holding the elongated electrode lead, wherein the second needle is retractable relative to the first needle, and wherein the method includes retracting the second needle to implant the electrode lead.

61. The method of claim 60, wherein: The first needle includes a side opening, and wherein a portion of the elongated electrode lead passes through the side opening when the delivery sheath is rotated.

62. The method of claim 60 or claim 61, wherein: As the delivery sheath is rotated, the first needle is percutaneously positioned.

63. The method of claim 60 or claim 61, wherein: The first needle is not percutaneously positioned when the delivery sheath is rotated.

64. The method of claim 63, wherein: The first needle is percutaneously positioned when the second needle is retracted, and the method further includes withdrawing the first needle to a non-percutaneous position before rotating the delivery sheath, and reinserting the first needle into patient tissue before implanting the housing portion.

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