# US 12,214,210 B2 · Minimally invasive leadless neurostimulation device > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 12,214,210 B2 - Document ID: US12214210B2 - Status: Granted - Kind: B2 - Application number: 17/485,303 - Filed: 2021-09-24 - Published: 2022-03-31 - Granted: 2025-02-04 - Earliest claimed: 2020-09-25 - Assignees: Medtronic, Inc. - Applicants: Medtronic, Inc. - Inventors: Steven T. Deininger; Jerel K. Mueller; Todd V. Smith; Jeffrey Clayton; Thomas M. Hillebrand; Phillip C. Falkner; Jenna N. George; Sarah J. Offutt - Web page: https://patentgrep.com/patent/US12214210B2 ## CPC - A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators} - A61N 1/0551: {Spinal or peripheral nerve electrodes} - A61N 1/36007: {of urogenital or gastrointestinal organs, e.g. for incontinence control} - A61N 1/37518: {Anchoring of the implants, e.g. fixation} - A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B) ## Abstract A leadless neurostimulation device having a header unit including at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device, a housing including a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, and a anchor device including at least one suture point for securing the leadless neurostimulation device to patient tissue or at least one protrusion nub configured to create mechanical resistance that impedes relative movement between wherein the leadless neurostimulation device and the patient tissue when implanted, where the at least one primary electrode and the secondary electrode are configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a target nerve of a patient. ## Claims ### Claim 1 A leadless neurostimulation device comprising: a header unit comprising: at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device, the at least one primary electrode comprising a cathode; a housing comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, the secondary electrode comprising an anode; and processing circuitry within the housing configured to deliver electrical stimulation therapy, the processing circuitry electrically coupled to the at least one primary electrode and secondary electrode and are configured to transmit an electrical stimulation signal between the cathode in the header unit and the anode on the housing to provide the electrical stimulation therapy to a target nerve of a patient. ### Claim 2 (depends on 1) The leadless neurostimulation device of claim 1, wherein the header unit further comprises an outer housing that forms a side of the header unit opposite of the contact surface of the primary electrode; and a dielectric mount that receives at least a portion of the at least one primary electrode and at least partially surrounds the at least one primary electrode. ### Claim 3 (depends on 2) The leadless neurostimulation device of claim 2, wherein the dielectric mount is configured to electrically insulate the at least one primary electrode from the outer housing, the dielectric mount being received and fixed within a recessed portion of the outer housing. ### Claim 4 (depends on 1) The leadless neurostimulation device of claim 1, wherein the header unit comprises two to four primary electrodes each having a contact surface that forms an exterior surface of the header unit. ### Claim 5 (depends on 4) The leadless neurostimulation device of claim 4, wherein at least one of the two to four primary electrodes is configured to sense a relative location of a tibial nerve prior to delivery of stimulation therapy. ### Claim 6 (depends on 1) The leadless neurostimulation device of claim 1, wherein the contact surface of the at least one primary electrode is about 20 mm2 to about 25 mm2. ### Claim 7 (depends on 1) The leadless neurostimulation device of claim 1, wherein the at least one primary electrode and the secondary electrode define a separation distance of about 10 mm to about 20 mm. ### Claim 8 (depends on 1) The leadless neurostimulation device of claim 1, wherein the secondary electrode defines a contact surface area of about 40 mm2 to about 120 mm2. ### Claim 9 (depends on 1) The leadless neurostimulation device of claim 1, further comprising a dielectric coating or a dielectric surface treatment that electrically insulates at least one primary electrode from the secondary electrode along an exterior surface of the device. ### Claim 10 (depends on 9) The leadless neurostimulation device claim 9, wherein a boundary defined by the dielectric coating or the dielectric surface treatment defines the secondary electrode. ### Claim 11 (depends on 1) The leadless neurostimulation device of claim 1, wherein the device defines a total volume of about 0.5 cubic centimeters (cc) to about 5 cc. ### Claim 12 (depends on 1) The leadless neurostimulation device of claim 1, further comprising a mounting plate, wherein the housing is coupled to a first side of the mounting plate and the header unit is coupled to a second side of the mounting plate. ### Claim 13 (depends on 1) The leadless neurostimulation device of claim 1, wherein the at least one primary electrode is sized and shaped to have an impedance of about 200 ohms to about 2,000 ohms when the leadless neurostimulation device is implanted. ### Claim 14 A leadless neurostimulation device comprising: a header unit comprising: at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device, the at least one primary electrode comprising a cathode; a housing comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, the secondary electrode comprising an anode; and a suture anchor device comprising at least one suture point for securing the leadless neurostimulation device to patient tissue, wherein the leadless neurostimulation device includes processing circuitry electrically coupled to the at least one primary electrode and the secondary electrode and are configured to transmit and receive, respectively, an electrical stimulation signal between the cathode and the anode to provide electrical stimulation therapy to a target nerve of a patient. ### Claim 15 (depends on 14) The leadless neurostimulation device of claim 14, wherein the housing comprises a tubular body and an endcap coupled together, wherein the endcap comprises the suture anchor device. ### Claim 16 (depends on 14) The leadless neurostimulation device of claim 14, wherein the suture anchor device comprises a flexible endcap configured to receive a portion of the housing. ### Claim 17 (depends on 14) The leadless neurostimulation device of claim 14, wherein the suture anchor device comprises at least one suture point arranged flush with a side of the suture anchor device that is on the same side of the leadless neurostimulation device as the secondary electrode. ### Claim 18 (depends on 14) The leadless neurostimulation device of claim 14, wherein the leadless neurostimulation device or the suture anchor device further comprises at least one protrusion nub configured to create mechanical resistance that impedes relative movement between wherein the leadless neurostimulation device and the patient tissue when implanted. ### Claim 19 A leadless neurostimulation device comprising: a header unit comprising: at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device; an outer housing that forms a side of the header unit opposite of the contact surface of the primary electrode; and a dielectric mount that receives at least a portion of the at least one primary electrode and at least partially surrounds the at least one primary electrode, the dielectric mount being configured to electrically insulate the at least one primary electrode from the outer housing, the dielectric mount being received and fixed within a recessed portion of the outer housing; a housing comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, the at least one primary electrode and the secondary electrode being configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a tibial nerve of a patient, a dielectric coating or a dielectric surface treatment that electrically insulates at least one primary electrode from the secondary electrode along an exterior surface of the device, wherein a boundary defined by the dielectric coating or the dielectric surface treatment defines the secondary electrode; and a suture anchor device comprising at least one suture point for securing the leadless neurostimulation device to patient tissue, wherein the at least one primary electrode and the secondary electrode define a separation distance of about 10 mm to about 20 mm, and wherein the leadless neurostimulation device defines a total volume of about 1.5 cubic centimeters (cc) to about 3.5 cc. ### Claim 20 (depends on 19) The leadless neurostimulation device of claim 19, wherein the housing comprises a tubular body and an endcap coupled together, wherein the endcap comprises the suture anchor device. ### Claim 21 (depends on 19) The leadless neurostimulation device of claim 19, wherein the suture anchor device comprises a flexible endcap configured to receive a portion of the housing. ### Claim 22 (depends on 19) The leadless neurostimulation device of claim 19, wherein the contact surface of the at least one primary electrode is about 20 mm2 to about 25 mm2, and further wherein the secondary electrode defines a contact surface area of about 40 mm2 to about 120 mm2. ### Claim 23 A leadless neurostimulation device comprising: a header unit comprising: at least one primary electrode having a contact surface that defines an external surface of the leadless neurostimulation device; an outer housing that forms a side of the header unit opposite of the contact surface of the primary electrode; and a dielectric mount that receives at least a portion of the at least one primary electrode and at least partially surrounds the at least one primary electrode, wherein the dielectric mount is configured to electrically insulate the at least one primary electrode from the outer housing, the dielectric mount being received and fixed within a recessed portion of the outer housing; and a housing comprising a secondary electrode positioned on the same side of the leadless neurostimulation device as the at least one primary electrode, wherein the at least one primary electrode and the secondary electrode are configured to transmit an electrical stimulation signal therebetween to provide electrical stimulation therapy to a target nerve of a patient.