Minimally invasive leadless neurostimulation device

Abstract

A leadless nerve stimulation device includes a head unit having at least one primary electrode having a contact surface defining an outer surface on one side of the device, an outer housing forming a side of the head unit opposite the contact surface of the primary electrode, and a dielectric base receiving at least a portion of the primary electrode and at least partially surrounding the primary electrode, the dielectric base configured to electrically insulate the primary electrode from the outer housing, the dielectric base received and secured within a recessed portion of the outer housing, the housing having a secondary electrode positioned on the same side of the leadless nerve stimulation device as the primary electrode, the primary electrode and the secondary electrode configured to transmit an electrical stimulation signal between the primary electrode and the secondary electrode to provide electrical stimulation therapy to a tibial nerve of a patient.

Description

[0001] Cross-references to related applications

[0002] This application claims the benefit of U.S. Provisional Application Serial No. 63 / 198,053, filed September 25, 2020, the disclosure of which is hereby incorporated by reference in its entirety. This application relates to, but does not claim the benefits of U.S. Provisional Application Serial Nos. 63 / 198,054, filed September 25, 2020, and 63 / 199,274, filed December 17, 2020, the disclosures of which are hereby incorporated by reference in their entirety. Technical Field

[0003] This application relates to implantable medical devices, and more specifically to minimally invasive implantable neurostimulation devices. Background Technology

[0004] Implantable medical devices can be configured to deliver electrical stimulation therapy or monitor physiological signals. For example, electrical stimulation of nerve tissue can provide relief for a variety of conditions, thereby improving the quality of life for many patients.

[0005] Some implantable medical devices (IMDs) may employ electrical leads carrying electrodes. For example, the electrodes may be positioned at the distal portion of an elongated lead. Other examples of electrical leads may be relatively short, having one or more electrodes positioned along the lead body. Such electrical leads are provided separately from the housing or body of the IMD and are coupled to the IMD during implantation to provide stimulation via electrodes located separately from the housing of the IMD.

[0006] The simulation of different nerve branches and nerve clusters has been explored for the treatment of various diseases. One promising approach has been the stimulation of the tibial nerve to treat certain conditions, such as incontinence or overactive bladder. Summary of the Invention

[0007] The embodiments disclosed herein relate to a minimally invasive, leadless neurostimulation device. The leadless device eliminates the need for separate leads, instead providing a more robust and less invasive integrated structured device than its lead-based counterpart.

[0008] The disclosed device includes a housing and an attached head unit, the housing housing components configured for delivering neurostimulation therapy. The head unit includes one or more main electrodes forming part of the exterior and sides of the head unit. The one or more main electrodes are electrically insulated from other portions of the outer surface of the neurostimulation device. The housing of the neurostimulation device includes a secondary electrode that operates in conjunction with the one or more main electrodes to provide electrical analog therapy or neurosensory capabilities. The secondary electrode is positioned on the same side of the device as the one or more main electrodes positioned in the head unit.

[0009] In one embodiment, this disclosure describes a system comprising a leadless nerve stimulation device including a head unit and a housing, the head unit having at least one main electrode having a contact surface defining an outer surface on one side of the leadless nerve stimulation device; a housing forming a side of the head unit opposite to the contact surface of the main electrode; and a dielectric base receiving at least a portion of the at least one main electrode and at least partially surrounding the at least one main electrode, the dielectric base being configured to electrically insulate the at least one main electrode from the housing, the dielectric base being received and secured within a recess of the housing, the housing having a secondary electrode positioned on the same side of the leadless nerve stimulation device as the at least one main electrode, the at least one main electrode and the secondary electrode being configured to transmit an electrical stimulation signal between the at least one main electrode and the secondary electrode to provide electrical stimulation therapy to the tibial nerve of a patient.

[0010] In one embodiment, this disclosure describes a leadless nerve stimulation device comprising a head unit including at least one main electrode that contacts a contact surface having an outer surface defining one side of the wireless nerve stimulation device; a housing forming one side of the head unit opposite the contact surface of the main electrode; and a dielectric base receiving at least a portion of the at least one main electrode and at least partially surrounding the at least one main electrode, the dielectric base being configured to electrically insulate the at least one main electrode from the housing, the dielectric base being received and secured within a recess of the housing, wherein the dielectric base defines a channel between the housing and the dielectric base, the channel being configured to receive a medical adhesive therein to secure the housing to the dielectric base, and wherein the main electrode includes an inner surface that defines an interlocking structure with the dielectric base. The leadless nerve stimulation device also includes a housing and a lead pin. The housing includes a secondary electrode positioned on the same side of the at least one primary electrode as the at least one primary electrode. The at least one primary electrode and the secondary electrode are configured to transmit an electrical stimulation signal between the at least one primary electrode and the secondary electrode to provide electrical stimulation therapy to the patient's tibial nerve. The lead pin is configured to pass through a mounting plate and connect to a processing circuitry and components housed in the housing. The processing circuitry and components are configured to transmit the electrical stimulation signal between one or more primary electrodes or secondary electrodes to provide electrical stimulation therapy to the tibial nerve, wherein the primary electrode is electrically coupled to the lead pin. The leadless nerve stimulation device also includes a mounting plate, wherein the housing is coupled to a first side of the mounting plate, and the head unit is coupled to a second side of the mounting plate. The at least one primary electrode and the secondary electrode define a separation distance of about 10 mm to about 20 mm, and the leadless nerve stimulation device defines a total volume of about 1.5 cubic centimeters (cc) to about 3.5 cc.

[0011] In one embodiment, this disclosure describes a method of manufacturing a leadless neurostimulation device, the method comprising: forming a head unit including a main electrode having a contact surface defining an outer surface on one side of the leadless neurostimulation device; forming the head unit comprising: forming a housing as a side of the head unit opposite to the contact surface of the main electrode; forming a dielectric base to receive at least a portion of the main electrode and at least partially surround the at least one main electrode, the dielectric base being configured to electrically insulate the at least one main electrode from the housing; and securing the dielectric base within a recess in the housing. The manufacturing method further comprises forming a casing including a secondary electrode positioned on the same side of the leadless neurostimulation device as the main electrode.

[0012] The above description is not intended to depict every illustrated embodiment or every embodiment of the subject matter of this invention. The following figures and detailed description illustrate various embodiments in more detail. Attached Figure Description

[0013] This disclosure can be more fully understood in conjunction with the accompanying drawings and the following detailed description of various embodiments thereof, wherein:

[0014] Figure 1 This is a schematic diagram illustrating an exemplary leadless nerve stimulation device as described herein.

[0015] Figures 2A to 2C yes Figure 1 A schematic diagram of an exemplary head unit and mounting plate for an implantable leadless nerve stimulation device.

[0016] Figure 3A This is a side view of the patient's leg, showing the area near the tibial nerve that was implanted in the patient's leg. Figure 1 A leadless nerve stimulation device.

[0017] Figure 3B This is a cross-sectional view of the patient's leg, showing the area near the tibial nerve that was implanted. Figure 1 A leadless nerve stimulation device.

[0018] While various embodiments may take various modifications and alternatives, the details of which have been shown by way of example in the accompanying drawings and will be described in detail. However, it should be understood that the intention is not to limit the claimed invention to the specific embodiments described. Rather, the intention is to cover all modifications, equivalents, and alternatives that fall within the spirit and scope of the subject matter as defined by the claims. Detailed Implementation

[0019] The leadless nerve stimulation device described herein can be used in various types of nerve stimulation therapy, such as for pain control, autonomic nervous system modulation, functional electrical stimulation, tremor, etc. In a preferred embodiment, the leadless nerve stimulation device described herein can be used to stimulate one or more nerves to control symptoms of overactive bladder, urinary frequency, nocturia, bladder pain syndrome, chronic pelvic pain, incontinence, or other pelvic health conditions. For example, these embodiments can also be used to stimulate one or more peripheral nerves to control pain in one or more areas of the body, such as the foot, ankle, leg, groin, shoulder, arm, wrist, or back. In one example, the disclosed leadless nerve stimulation device embodiment can be used to stimulate the tibial nerve in a patient.

[0020] Figure 1This is a schematic diagram illustrating an exemplary leadless nerve stimulation device 10. The leadless nerve stimulation device 10 includes a housing 12, a head unit 14, and a mounting plate 16. The housing houses components configured for delivering nerve stimulation therapy. The head unit includes one or more main electrodes 18. The mounting plate couples the housing 12 to the head unit 14. The head unit 14 includes at least one main electrode 18 forming a portion of the outer surface of the head unit 14. The housing 12 includes a secondary electrode 20 forming a portion of the outer surface of the housing 12 and positioned on the same side of the device 10 as the main electrode 18. In an alternative embodiment not depicted, the main electrode 18 and the secondary electrode 20 may be arranged on opposite sides of the device 10.

[0021] The main electrode 18 and the secondary electrode 20 operate together to deliver stimulation therapy to the target treatment site (e.g., the tibial nerve).

[0022] The secondary electrode 20 may also be referred to as a shell electrode, can electrode, or reference electrode. In one embodiment, the main electrode 18 may include a cathode, and the secondary electrode 20 may include an anode. In some embodiments, the main electrode 18 and the secondary electrode 20 may be characterized as a bipolar pair or a system.

[0023] The terms “primary” and “secondary” are used to distinguish between two or more electrodes configured to transmit electrical signals between them. These terms are not used to imply a hierarchy between electrodes, positive and negative terminals, the total number of electrodes, or the directionality of signal transmission between electrodes.

[0024] Figures 2A to 2C Various schematic diagrams are provided of the mounting plate 16 and the head unit 14, as well as the components housed therein. In particular, Figure 2A This is a schematic diagram of the head unit 14 partially assembled and coupled to the mounting plate 16. Figure 2B It is an exploded view showing how to assemble the head unit 14 and the mounting plate 16. Figure 2C yes Figure 2A The cross-sectional view along line AA shows a portion of the head unit 14.

[0025] The head unit 14 includes a housing 24, a main electrode 18, and a dielectric base 26. The housing 24 is coupled to a mounting plate 16 and may define a partially recessed cavity for receiving the dielectric base 26 and the main electrode 18. The housing 24 and the mounting plate 16 may be made of metal or metal alloy (e.g., titanium or titanium alloy) to allow for easy coupling between them (e.g., laser welding) and to allow the mounting plate 16 to be coupled to the housing 12. Alternatively, the housing 24 or the mounting plate 16 may be made of ceramic material or non-conductive plastic.

[0026] The housing or mounting plate is made of a material (e.g., polypropylene) and includes appropriate mechanisms (e.g., metal inserts) for coupling the housing 24 to the mounting plate 16.

[0027] In some embodiments, the seam between the mounting plate 16 and the housing 26 can form at least a partially hermetically sealed connection. As discussed further below, while the mounting plate 16 and housing 24 define the external shape and body of the leadless nerve stimulation device 10, the external surfaces of these components can be coated with a dielectric material to prevent the bodies of such components from interfering with the electrical pathways of the main electrode 18 and the secondary electrode 20, and to contribute to the hermetically sealed connection of the device 10. In alternative embodiments not depicted, the head unit 14 can be configured to be directly coupled to the housing 12 without requiring a separate mounting plate element.

[0028] The main electrode 18 defines an external contact surface 30 configured to make direct contact with the patient's tissue. The contact surface 30 may also form a portion of one side of the head unit 14, preferably on the same side of the device 10 as the secondary electrode 20. The outer perimeter of the contact surface 30 is bounded by a dielectric base 26, which also forms part of the outer surface of the head unit 14 and electrically insulates and physically separates the main electrode 18 from the housing 24 and the mounting plate 16.

[0029] The main electrode 18 can be of any suitable size and shape to deliver electrical stimulation to the tibial nerve through the patient's fascia layer. In some embodiments, the main electrode 18 can be defined as approximately 15 mm. 2 Approximately 90mm 2 The contact surface area. In a preferred embodiment including only a single main electrode 18, the contact surface area can be greater than about 15 mm². 2 Greater than approximately 18mm 2 Greater than approximately 20mm 2 Less than 35mm 2 Less than 30mm 2 and less than 25mm 2 As further discussed in the following provisional application serial numbers: 63 / 198,054 filed on 25 September 2020 and 63 / 199,274 filed on 17 December 2020, both entitled “Minimally Invasive Leadless Nerve Stimulation Device”, which is incorporated herein by reference, the surface areas of the main electrode 18 and the secondary electrode 20, as well as the separation distance between them, can be optimized to provide adequate penetration and stimulation of the tibial nerve through the fascia layer of the patient’s leg.

[0030] In some embodiments, the size, shape, and physical separation distance between the main electrode 18 and the secondary electrode 20 can be configured to produce an impedance of less than 2,000 ohms (e.g., between about 250 ohms and 1,000 ohms). Alternatively,

[0031] Alternatively, the main electrode 18 and the secondary electrode 20 can be arranged in a non-concentric manner, such that one electrode does not substantially surround the other electrode.

[0032] In some implementation schemes, such as Figure 1 As shown, the contact surface 30 of the main electrode can be substantially flat (e.g., flat or nearly flat). Alternatively, the main electrode 18 can define a curved surface (e.g., a semi-cylindrical shape or other 2D or 3D curved plane) that helps the main electrode 18 follow the curvature of the patient's fascia layer during implantation to provide better contact and focusing of electrical signals directed to the tibial nerve. The curved surface can extend across the entire contact surface 30 or only over a portion of the surface. Additionally or alternatively, the curvature can be limited to the contact surface 30 of the main electrode 18 or can extend over other parts of the device 10, such as the head 14, mounting plate 16, or other parts of the housing 12. By including curvature on other parts of the device 10, the device can provide a more ergonomic fit during implantation while also helping to direct stimulation signals to the tibial nerve.

[0033] In some embodiments, the contact surface 30 of the main electrode 18 may also protrude from the plane defined by the housing 12. Such protrusion can help apply additional pressure to the patient's fascia and help guide the electrical stimulation signal deeper into the patient's tissues. The main electrode 18 may also define one or more interlocking features, cuts, recesses, or other structures below the contact surface 30, which reduce the overall volume of the main electrode 18 without interfering with the contact surface 30. The reduced volume and interlocking features can also help reduce manufacturing costs and help secure the main electrode 18 relative to the dielectric base 26. In some embodiments, the contact surface 30 may have a textured finish, such as a laser-textured finish. Textured finishes can be added to the general shape described above. For example, the contact surface 30 may be flat or curved, with a laser texture added to the contact surface 30. In some examples, the contact surface 30 may include a titanium, titanium alloy, or platinum-iridium textured surface.

[0034] The main electrode 18 can be formed from any suitable material that, once implanted, can deliver electrical stimulation therapy to the patient and has the desired long-term biocompatibility with surrounding tissues. Such materials may include, but are not limited to, titanium, titanium alloys, platinum-iridium, etc. In a preferred embodiment, at least the contact surface 30 is formed of platinum-iridium, titanium, or a titanium alloy, while the body of the main electrode 18 may be made of the same or different materials.

[0035] For example, the body of the main electrode 18 can be formed of titanium or a titanium alloy, with the contact surface 30 formed of platinum-iridium. Using platinum-iridium can help reduce or eliminate the possibility of charge buildup on the outer surface of the device 10 during operation. Platinum-iridium also provides low impedance to surrounding body tissue, good biocompatibility, and works well as a contact surface for implantable electrodes. However, platinum-iridium can be expensive or may have reduced compatibility with other metals or alloys (e.g., metallurgical bonding).

[0036] In some implementations, the main electrode 18 may be made entirely of platinum-iridium, titanium, or a titanium alloy. Titanium or titanium alloys offer significant cost advantages compared to platinum-iridium or other specialty metals. However, titanium-based electrodes are generally discouraged in implantable devices that deliver chronic or long-term stimulation therapy. It is believed that such titanium-based electrodes can develop an oxide surface layer over time. This oxide layer along the electrode surface can increase the impedance between the electrode and body tissue and lead to charge buildup along the outer surface. Therefore, when using titanium-based electrodes that require increased voltage or current to deliver therapeutic stimulation levels, the efficacy of the stimulation therapy may decrease over time.

[0037] Due to the relatively large surface area of ​​the main electrode 18 (e.g., approximately 21 mm²), 2 It has been observed that when using titanium-based electrodes, the reduction in efficacy is negligible or completely avoidable. Therefore, titanium-based electrodes can be used for the main electrode 18 (including contact surface 30) without experiencing a reduction in efficacy during stimulation therapy over the lifetime of the device 10. In some embodiments, the main electrode 18 can be made of commercially pure titanium (e.g., a metal containing >99% Ti or Grade 2 titanium). Commercially pure titanium, particularly Grade 2 titanium, offers certain manufacturing advantages, including, for example, the ability to produce the main electrode 18 by machine stamping rather than casting or other expensive manufacturing processes. Titanium and selected titanium alloys are also generally accepted as biocompatible and suitable for constructing implantable medical devices.

[0038] Compared to platinum-iridium, titanium and titanium alloys also offer good compatibility with other metals and alloys (e.g., metallurgical bonding). For example, lead pin 42, which will be discussed further below, is used to couple the main electrode 18 to the device circuitry housed within the housing 12. Lead pin 42 may be made of niobium or niobium alloys.

[0039] Alloy composition. Brazing or welding between niobium and platinum-iridium has been found to have reduced metallurgical compatibility, leading to the introduction of microcracks and other signs of poor bonding through the otherwise good joint between the niobium and platinum-iridium metals. These microcracks can reduce the reliability and impedance of the device. In contrast, titanium has high compatibility with niobium and can be efficiently coupled to lead pin 42 by laser welding.

[0040] In some embodiments, the bonding between niobium and platinum-iridium is improved by using an intermediate or by constructing the body of the main electrode 18 with a material different from platinum-iridium. For example, the body of the main electrode 18 can be made of titanium, and the surface 30 can be coated with platinum-iridium (e.g., by sputtering or other deposition methods), thus providing the advantage of having a contact surface 30 formed of platinum-iridium while also achieving good bonding by using titanium. Alternatively, a titanium sleeve can be introduced between the niobium-based lead pin 42 and the platinum-iridium body of the main electrode 18 to achieve a similar effect. Titanium improves the electrical coupling between the lead pin 42 and the main electrode 18 because titanium can be effectively welded or friction-bonded to both niobium and platinum-iridium. The titanium body or sleeve acts as an intermediate between niobium and platinum-iridium to eliminate the presence of microcracks and other signs of poor bonding, thereby improving the conductivity transfer and reliability of the device 10 during its lifespan.

[0041] The dielectric base 26 is configured to conform to at least some of the inner surfaces of the main electrode 18 to help physically retain the main electrode 18 and electrically insulate it from the head unit 14 and other portions of the mounting plate 16. In some embodiments, the main electrode 18 and the dielectric base 26 define interlocking inner surfaces 32 that allow the main electrode 18 to remain within the dielectric base 26 and help prevent physical separation (e.g., removal of the main electrode 18 from the device 10). For example, the main electrode 18 may define at least a portion of the perimeter forming the inner surface of the main electrode and provide retaining channels, protrusions, or other physical structures for the interlocking surfaces 32. Additionally, the presence of structures providing the interlocking surfaces 32 can help reduce the total amount of material used to form the main electrode 18, which can reduce manufacturing costs and help secure the main electrode 18 relative to the dielectric base 26 and the head 14.

[0042] The dielectric base 26 can be formed of any suitable material that electrically insulates the main electrode 18 from the head unit 14 and other portions of the mounting plate 16. In some embodiments, the dielectric base 26 can be formed of liquid silicone rubber (LSR), silicone, or similar materials. For example, LSR, silicone, or other suitable dielectric materials can be cast or molded around the main electrode 18 to create a strong fit with the main electrode 18, preventing physical separation therefrom, and providing desired physical and electrical separation from portions of the housing 26 and the mounting plate 16. In some embodiments, the dielectric base 26 can be integrally formed with the housing 24, provided that these components are formed of a non-conductive material.

[0043] In some embodiments, the dielectric base 26 may also include one or more recesses or strategically positioned gaps that can accommodate medical adhesives to aid in the assembly of the head unit 14. For example, as Figures 2A to 2CAs shown, the dielectric base 26 can typically be formed to be received within a recessed region 34 defined by the housing 24. Along a portion of the adjacent surfaces between the dielectric base 26 and the housing 24, the dielectric base 26 may define a channel 36 configured to receive, after assembly, a suitable adhesive (e.g., non-conductive medical adhesive, epoxy volcanic silicone, etc.) to secure the dielectric base 24 and the housing 24 together. Figure 1 and Figure 2C As best seen in the middle, the housing may define a filling port 38, which is in fluid communication with the channel 36 and allows for the injection of adhesive after assembly.

[0044] The dielectric base 26 may also be shaped to provide a gap 40 between the mounting plate 16 and the main electrode 18. During assembly, the gap 40 provides pathways for coupling the one or more main electrodes 18 to corresponding lead pins 42 for electrically connecting the main electrodes 18 to a device circuitry housed within the housing 12. After the main electrodes 18 are coupled to the lead pins 42 (e.g., by soldering), the gap 40 may be filled with a dielectric material 44, such as medical adhesive, LSR, silicone, or other suitable materials injected through the fill port 38.

[0045] The housing 24 may form the majority of the body of the head unit 14. Specifically, the housing 24 forms a portion of the side of the head unit 14 opposite the contact surface 30, the peripheral edge (other than the contact surface where the mounting plate 16 is disposed), and the side of the head unit 14 that is the same as the contact surface 30 of the main electrode 18. In some embodiments, the housing 24 may have a circular, semi-circular, or D-shaped peripheral edge, providing a relatively smooth surface without any steep or sharp edges or lines that could cause irritation to the patient after implantation. In some embodiments, the housing 24 is configured to receive and form a partial shell surrounding the dielectric base 26. Thus, the housing 24 may define a concave inner surface (not shown) that receives a portion of the dielectric base 26. The dielectric base 26 may be secured to the housing 26 using a suitable medical adhesive.

[0046] The head unit 14 is coupled to the mounting plate 16, and the mounting plate 16 is similarly coupled to the housing 12. The housing 12 includes a secondary electrode 20. In some embodiments, the secondary electrode 20 may be defined by a region of the body of the housing 12. For example, the housing 12 may be formed of a metallic material (e.g., titanium) and electrically coupled to the processing circuitry of the leadless neurostimulation device 10. In addition to defining the surface regions defining the secondary electrode 20 and the main electrode 18, the outer surface of the housing 12 (including portions of the mounting plate 16 and the head unit 14) may be coated with a dielectric material. The dielectric material may at least partially encapsulate the device 10 such that the boundary created by the dielectric material defines the region of the secondary electrode 20, the contact surface 30, or both.

[0047] Any suitable technique can be used to apply the dielectric coating. In some such examples, the area defining the contact surface 30 and the sub-electrode 20 can be masked with a suitable material such as a strip. The leadless neurostimulation device 10 can then be coated with an adhesive dielectric material using similar techniques such as vapor deposition, dip coating, or spraying, followed by removal of the masking material to expose the surfaces of the contact surface 30 and the sub-electrode 20.

[0048] Suitable dielectric materials for coating the leadless neurostimulation device 10 may include, but are not limited to, parylene, LSR, or silicone. Alternatively or additionally, the outer surface or portions thereof of the neurostimulation device 10 may include surface treatments, such as anodizing, to alter portions of the surface to make it non-conductive. For example, portions of the housing 12, the outer shell 24, or both (if made of a metal (e.g., titanium)) may be anodized to make selected surfaces non-conductive. In such examples, for the purposes of this disclosure, the outer surface of the component may still be characterized as metallic (e.g., titanium) despite the component having undergone such surface treatment.

[0049] In a preferred example, the outer surface of the leadless nerve stimulation device 10 may be formed primarily of parylene. The desired electrode profile may be formed using dielectric blocking methods (e.g., using a masking material during manufacturing) or dielectric removal methods (e.g., removal via laser or soda blasting) without damaging the dielectric coating.

[0050] In some embodiments, a dielectric coating can also help create a hermetically sealed environment around the leadless neurostimulation device 10. A general configuration in which the head 14 and housing 12 are respectively attached to the mounting plate 16 can also create a hermetically sealed environment within the device 10. Coating the device 10 with a dielectric material having sealing properties (such as parylene, LSR, or silicone) can provide additional robustness to the hermetically sealed environment of the device 10. Providing the leadless neurostimulation device 10 in a hermetically sealed form can contribute to the long-term functionality of the device, thus offering advantages over other non-hermetically sealed devices.

[0051] The secondary electrode 20 can be defined as approximately 40 mm. 2 Approximately 120mm 2 The contact surface area. However, a device with a larger secondary electrode can increase the minimum current required to generate a therapeutic response. The separation distance between the main electrode 18 and the secondary electrode 20 can be from about 5 mm to about 15 mm.

[0052] The processing circuitry and components of the neurostimulation device 10 are housed within the housing 12. Examples of such processing components may include one or more electronic circuits for delivering electrical stimulation therapy, telemetry hardware, a power supply, memory, and a processor. The housing 12 may also include a communication circuitry system disposed therein for receiving programming communications from an external programmer or providing feedback to a programmer or other external device.

[0053] In one example, housing 12 may include an energy source enclosed therein, such as a rechargeable or non-rechargeable battery. In another example, leadless neurostimulator 10 may also be configured to receive energy signals from an external device and convert the received energy signals into electrical power for recharging the device's battery, energy source (e.g., battery), processing circuitry, and other necessary components enclosed therein. In some embodiments, device 10 may be configured to receive energy signals from an external device and convert the received energy signals into electrical power for recharging the battery of device 10. Alternatively or additionally, device 10 may include a non-rechargeable main cell battery.

[0054] In some embodiments, the housing 12 and its various processing components of the leadless neurostimulation device 10 can be substantially similar to the housing portion of the InterStim microneurostimulator available from Medtronic. The InterStim microneurostimulator can be modified to accommodate the head unit 14 described herein, as well as...

[0055] Modifications to the secondary electrode 20 are provided. The overall volume of the neurostimulation device 10 can also be relatively small. In some embodiments, the device 10 can have an overall volume of about 0.5 cubic centimeters (cc) to about 6 cc, about 1.5 cc to about 3.5 cc, or about 2 cc to about 3 cc.

[0056] Now, referring to implantation, Figure 3A This is a side view of the patient's leg at angle 100, showing the implanted... Figure 1 The leadless nerve stimulation device 10, and Figure 3BA schematic cross-sectional view of a leadless nerve stimulation device 10 implanted in the patient's leg 100 near the ankle, adjacent to the tibial nerve 102. The cross-section of the leg 100 shows the tibia 104, fibula 106, peroneus tertiary muscle 108, flexor digitorum longus 110, flexor hallucis longus 112, peroneus brevis 114, soleus muscle 116, posterior tibial artery 118, posterior tibial vein 120, skin 122, subcutaneous fat layer 124, and fascia layer 126. The device 10 can be implanted through the skin 122 and subcutaneous fat layer 124 via a small incision 101 above the tibial nerve on the medial side of the patient's ankle. Device 10 can be positioned adjacent to the region defined by flexor digitorum longus 110, flexor hallucis longus 112 and soleus 116, wherein tibial nerve 102 is accommodated and implanted near and proximal to fascia layer 128, wherein main electrode 18 and secondary electrode 20 face tibial nerve 102.

[0057] In one embodiment, the incision 101 does not penetrate the fascia layer 128, thereby reducing the risk of complications from the surgical procedure. Although the incision 101 is shown as being approximately horizontal to the length of the tibial nerve, other incisions or implantation techniques may be used depending on the physician's preference. In one embodiment, a leadless nerve stimulation device 10 may be implanted such that the main electrode 18 is oriented downward relative to the secondary electrode 20.

[0058] Optional tests can be performed on the leadless nerve stimulation device 10 to determine whether the device 10 is properly positioned near the tibial nerve 102 to elicit a desired response from applied electrical stimulation. In one example, the device 10 is controlled by an external programmer to deliver test stimuli and monitor one or more indicative responses, such as simulated toe flexion or tingling in the heel or sole of the foot, other than the medial arch, from tibial motor neurons controlling the flexor hallucis brevis or flexor digitorum brevis muscles. If such tests do not elicit an appropriate motor or sensory response, the physician can reposition the device 10 and repeat the test.

[0059] Once the physician has determined that the device 10 is properly positioned to provide an appropriate patient response to the delivered stimulation therapy, the housing 12 can be secured in place if necessary. This anchoring device may be optional due to the natural shape of the area where the device 10 is implanted, and the shape of the device 10 itself has shown good compatibility with the surrounding tissue, thus preventing displacement or rolling of the device 10 after implantation. In some embodiments, the filamentless nerve stimulation device 10 may also include one or more suture points to help secure the device 10 to the fascia 102 or other parts of the leg 100. In some embodiments, suture anchors 130 may be included at the distal end of the housing 12 opposite the end attached to the mounting plate 16.

[0060] The advantages of the device and method described herein can improve patient safety and satisfaction after implantation. Compared with other methods, the leadless nerve stimulation device 10 does not require interference with the fascia layer 126, which can reduce the risks associated with replacement procedures. Furthermore, because the device 10 is a monolithic structure and can be hermetically sealed, it is more robust than other lead-based stimulation units.

[0061] During operation, an electrical stimulation signal can be transmitted between the main electrode 18 and the secondary electrode 20 through the fascia layer 126. This electrical signal can be used to stimulate the tibial nerve 102, which can be used to treat symptoms of overactive bladder (OAB) such as urinary urgency, urinary frequency, and / or urge incontinence or fecal incontinence.

[0062] Various embodiments of the systems, apparatus, and methods have been described herein. These embodiments are given by way of example only and are not intended to limit the scope of the claimed invention. Furthermore, it should be understood that various features of the described embodiments can be combined in various ways to produce many other embodiments. Moreover, while various materials, sizes, shapes, configurations, and positions, etc., used with the disclosed embodiments have been described, other materials, sizes, shapes, configurations, and positions, etc., may be utilized without exceeding the scope of the claimed invention.

[0063] It should be understood that the various aspects disclosed herein can be combined in combinations different from those specifically given in the specification and drawings. It should also be understood that, depending on the example, certain actions or events of any of the processes or methods described herein may be performed in a different order, or may be completely added, combined, or omitted (e.g., performing these techniques may not require all the described actions or events). Furthermore, although for clarity some aspects of this disclosure are described as being performed by a single module or unit, it should be understood that the techniques of this disclosure can be performed by combinations of units or modules associated with, for example, a medical device.

[0064] In one or more examples, the described techniques can be implemented in hardware, software, firmware, or any combination thereof. If implemented in software, the functionality can be stored as one or more instructions or code on a computer-readable medium and executed by a hardware-based processing unit. Computer-readable media can include non-transitory computer-readable media, which corresponds to tangible media such as data storage media (e.g., RAM, ROM, EEPROM, flash memory, or any other medium that can be used to store desired program code in the form of instructions or data structures and is accessible by a computer). The instructions can be executed by one or more processors, such as one or more digital signal processors (DSPs), general-purpose microprocessors, application-specific integrated circuits (ASICs), field-programmable arrays (FPGAs), or other equivalent integrated or discrete logic circuit systems. Therefore, the term "processor" as used herein can refer to any of the foregoing structures or any other physical structures suitable for implementing the described techniques. Furthermore, the techniques can be fully implemented in one or more circuit or logic elements.

[0065] Those skilled in the art will recognize that the subject matter of this invention may include fewer features than those shown in any of the individual embodiments described above. The embodiments described herein are not intended to be an exhaustive representation of the various ways in which the subject matter of this invention can be combined.

[0066] Therefore, these embodiments are not mutually exclusive combinations of features; rather, as those skilled in the art will understand, each embodiment may include combinations of different individual features selected from different individual embodiments. Furthermore, unless otherwise specified, elements described with respect to one embodiment may be implemented in other embodiments, even if such elements are not described in such embodiments.

[0067] Although a dependent claim may refer in the claims statement to a specific combination with one or more other claims, other embodiments may also include combinations of a dependent claim with the subject matter of each of the other dependent claims, or combinations of one or more features with other dependent claims or independent claims. Such combinations are presented herein unless stated otherwise.

Claims

1. A leadless nerve stimulation device, the leadless nerve stimulation device comprising: Header unit, the head unit comprising: The main electrode has a contact surface that defines an outer surface on one side of the leadless nerve stimulation device; A housing, the housing forming one side of the head unit opposite the contact surface of the main electrode; and A dielectric base receiving at least a portion of the main electrode and at least partially surrounding the main electrode, the dielectric base being configured to electrically insulate the main electrode from the housing, the dielectric base being received and secured within a recess of the housing; and The housing includes a secondary electrode positioned on the same side as the main electrode of the leadless nerve stimulation device, the main electrode and the secondary electrode being configured to transmit electrical stimulation signals between the main electrode and the secondary electrode to provide electrical stimulation therapy to the patient's tibial nerve.

2. The leadless nerve stimulation device according to claim 1, wherein the main electrode includes an inner surface, and the inner surface and the dielectric base define an interlocking structure.

3. The leadless nerve stimulation device of claim 1, further comprising a lead pin configured to pass through a mounting plate and connect to a processing circuit system and components housed in the housing, the processing circuit system and components being configured to transmit the electrical stimulation signal between a main electrode and a secondary electrode to provide electrical stimulation therapy to the tibial nerve, wherein the main electrode is electrically coupled to the lead pin.

4. The leadless nerve stimulation device according to claim 3, wherein the main electrode may comprise one or more of grade 2 titanium, titanium alloy, or platinum-iridium alloy.

5. The leadless nerve stimulation device of claim 1, wherein the dielectric base defines a channel between the housing and the dielectric base, the channel being configured to receive a medical adhesive deposited therein to secure the housing to the dielectric base.

6. The leadless nerve stimulation device of claim 5, wherein the housing defines a filling port in fluid communication with the channel to allow the medical adhesive to be injected into the channel.

7. The leadless nerve stimulation device according to claim 1, wherein the contact surface of the main electrode is 15 mm. 2 Up to 35mm 2 .

8. The leadless nerve stimulation device according to claim 1, wherein the contact surface of the main electrode is 20 mm. 2 Up to 25mm 2 .

9. The leadless nerve stimulation device according to claim 1, wherein the main electrode and the secondary electrode are separated by a distance of 10 mm to 20 mm.

10. The leadless nerve stimulation device according to claim 1, wherein the secondary electrode is defined as 40 mm. 2 Up to 120mm 2 The contact surface area.

11. The leadless nerve stimulation device according to claim 1, wherein the leadless nerve stimulation device further comprises a dielectric coating that at least partially encapsulates the leadless nerve stimulation device.

12. The leadless nerve stimulation device of claim 11, wherein the secondary electrode is defined by the boundary defined by the dielectric coating.

13. The leadless nerve stimulation device according to claim 1, wherein the device is defined as having a total volume of 1.5 cubic centimeters to 3.5 cubic centimeters.

14. The leadless nerve stimulation device according to claim 1, further comprising a mounting plate, wherein the housing is coupled to a first side of the mounting plate, and the head unit is coupled to a second side of the mounting plate.

15. The leadless nerve stimulation device according to claim 3, wherein the lead pin comprises niobium.

16. A leadless nerve stimulation device, the leadless nerve stimulation device comprising: Header unit, the head unit comprising: The main electrode has a contact surface that defines an outer surface on one side of the leadless nerve stimulation device; A housing, the housing forming one side of the head unit opposite the contact surface of the main electrode; and A dielectric base receiving at least a portion of the main electrode and at least partially surrounding the main electrode, the dielectric base being configured to electrically insulate the main electrode from the housing, the dielectric base being received and secured within a recess of the housing. The dielectric base defines a channel between the housing and the dielectric base, the channel being configured to receive medical adhesive therein to secure the housing to the dielectric base. The housing includes a secondary electrode positioned on the same side as the main electrode of the leadless nerve stimulation device, the main electrode and the secondary electrode being configured to transmit an electrical stimulation signal between the main electrode and the secondary electrode to provide electrical stimulation therapy to the patient's tibial nerve; At least one lead pin configured to pass through a mounting plate and connect to a processing circuitry and components housed in the housing, the processing circuitry and components being configured to transmit the electrical stimulation signal between a main electrode and a secondary electrode to provide electrical stimulation therapy to the tibial nerve, wherein the main electrode is electrically coupled to the lead pin; and Mounting plate, wherein the housing is coupled to a first side of the mounting plate, and the head unit is coupled to a second side of the mounting plate. The main electrode and the secondary electrode are defined with a separation distance of 5 mm to 20 mm, and The leadless nerve stimulation device is defined as having a total volume of 1.5 cubic centimeters to 3.5 cubic centimeters.

17. The leadless nerve stimulation device according to claim 16, wherein the separation distance between the main electrode and the secondary electrode is 5 mm to 15 mm.

18. The leadless nerve stimulation device according to claim 16, wherein the separation distance between the main electrode and the secondary electrode is 10 mm to 20 mm.

19. The leadless nerve stimulation device of claim 16, wherein the main electrode includes an inner surface, the inner surface defining an interlocking structure with the dielectric base.

20. The leadless nerve stimulation device of claim 16, further comprising a dielectric coating that at least partially encapsulates the leadless nerve stimulation device.

21. The leadless nerve stimulation device of claim 20, wherein the secondary electrode is defined by the boundary defined by the dielectric coating.

22. The leadless nerve stimulation device of claim 16, wherein the main electrode may comprise one or more of grade 2 titanium, titanium alloy, or platinum-iridium alloy.

23. The leadless nerve stimulation device of claim 16, wherein the lead pin comprises niobium.

24. The leadless nerve stimulation device according to claim 16, wherein the contact surface of the main electrode is 20 mm. 2 Up to 25mm 2 .

25. The leadless nerve stimulation device of claim 16, wherein the secondary electrode is defined as 40 mm. 2 Up to 120mm 2 The contact surface area.

26. The leadless nerve stimulation device of claim 16, wherein the housing defines a filling port in fluid communication with the channel to allow the medical adhesive to be injected into the channel.

27. A method for manufacturing a leadless nerve stimulation device, the method comprising: Forming a head unit, the head unit including a main electrode having a contact surface defining an outer surface on one side of the leadless nerve stimulation device, the formation of the head unit comprising: The outer shell is formed as the side of the head unit opposite to the contact surface of the main electrode; A dielectric base is formed to receive at least a portion of the main electrode and at least partially surround the main electrode, the dielectric base being configured to electrically insulate the main electrode from the housing; and The dielectric base is fixed within the recessed portion of the outer casing; and A housing is formed, the housing including a secondary electrode positioned on the same side as the primary electrode of the leadless nerve stimulation device.

28. The method of manufacturing a leadless nerve stimulation device according to claim 27, wherein the step of forming the head unit further comprises forming the main electrode having an inner surface, the inner surface defining an interlocking structure with the dielectric base.

29. The method of manufacturing a leadless nerve stimulation device according to claim 27, the method further comprising: Form at least one lead pin; Pass the lead pin through the mounting plate; The lead pin is connected to a processing circuit system and components housed in the housing, the processing circuit system and components being configured to transmit an electrical stimulation signal between the main electrode and the sub-electrode; and The lead pin is electrically coupled to the main electrode.

30. The method of manufacturing a leadless nerve stimulation device according to claim 29, wherein electrically coupling the lead pin to the main electrode comprises: The main electrode is directly coupled to the lead pin, wherein the main electrode comprises titanium or platinum-iridium; or A titanium sleeve is coupled to the lead pin as an intermediate body between the lead pin and the main electrode.

31. The method of manufacturing a leadless nerve stimulation device according to claim 27, wherein the dielectric base defines a channel between the housing and the dielectric base, the method further comprising: Medical adhesive is deposited in the channel to secure the housing to the dielectric base.

32. The method of manufacturing a leadless nerve stimulation device according to claim 31, wherein the housing defines a filling port in fluid communication with the channel, and the step of depositing the medical adhesive in the channel further comprises: Medical adhesive is injected into the filling port.

33. The method of manufacturing a leadless nerve stimulation device according to claim 28, the method further comprising: At least a portion of the leadless nerve stimulation device is coated with a dielectric material; as well as The secondary electrode is defined by the boundary of the dielectric material.

Images