System for transmitting electrical current to a bodily tissue

• US 9,757,554 B2
• Filed: 02/24/2015
• Issued: 09/12/2017
• Est. Priority Date: 08/23/2007
• Status: Active Grant

• Current Assignee: Bioness Inc. (Smith & Nephew PLC)
• Original Assignee: Bioness Inc. (Smith & Nephew PLC)
• Inventors: Dar, Amit, Feldman, Shai, Glukhovsky, Arkady, Springer, Shmuel, Regev, Einan
• Primary Examiner(s): Holmes, Rex R
• Application Number:
  US14/630,329
• Publication Number:
  US 20150165186A1
• Time in Patent Office: 931 Days
• CPC Class Codes: A61N 1/0456 Specially adapted for transcutaneous electrical nerve stimulation [TENS]
• CPC Class Codes: A61N 1/0472 Structure-related aspects
• CPC Class Codes: A61N 1/048 Electrodes characterised by a specific connection between lead and electrode
• CPC Class Codes: A61N 1/0492 Patch electrodes A61N1/0412, A61N1/0428 take precedence
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/36021 for treatment of pain
• CPC Class Codes: A61N 1/3625 External stimulators
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators
• CPC Class Codes: A61N 1/3758 Packaging of the components within the casing
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

In some embodiments, an apparatus includes a substantially rigid base and a flexible substrate. The substantially rigid base has a first protrusion and a second protrusion, and is configured to be coupled to an electronic device. The flexible substrate has a first surface and a second surface, and includes an electrical circuit configured to electronically couple the electronic device to at least one of an electrode a battery, or an antenna. The flexible substrate is coupled to the base such that a first portion of the second surface is in contact with the first protrusion. A second portion of the second surface is non-parallel to the first portion.

Claims

1. An apparatus, comprising:

a stimulator assembly including a stimulus generator, a power source, and a housing disposed about at least a portion of the stimulus generator and the power source, the stimulus generator being electrically coupled to the power source; and

an electrode assembly removably coupleable to the stimulator assembly, the electrode assembly including a flexible substrate, a plurality of electrodes, and a connector assembly, the connector assembly including at least a first snap-fit connector and a second snap-fit connector coupled to a first surface of the flexible substrate, the first snap-fit connector configured to removably (1) electrically couple the stimulator assembly to the electrode assembly such that a first electrical connection is formed between the stimulator assembly and the electrode assembly, and (2) mechanically couple the stimulator assembly to the electrode assembly such that the stimulator assembly is supported by the electrode assembly, the second snap-fit connector configured to removably (1) electrically couple the stimulator assembly to the electrode assembly such that a second electrical connection different from the first electrical connection is formed between the stimulator assembly and the electrode assembly, and (2) mechanically couple the stimulator assembly to the electrode assembly such that the stimulator assembly is supported by the electrode assembly, the plurality of electrodes being disposed on a second surface of the flexible substrate different from the first surface, the plurality of electrodes configured to adhere to a bodily tissue and to convey an electric current produced by the stimulus generator to at least a portion of the bodily tissue.

2. The apparatus of claim 1, wherein the housing includes a receiving portion configured to receive the at least the portion of the stimulus generator, a portion of the housing is configured to form a substantially fluid-tight seal proximate to the receiving portion when at least the portion of the stimulus generator is received in the receiving portion.

3. The apparatus of claim 1, wherein the stimulator assembly includes a connector assembly configured to be removably coupled to the connector assembly of the electrode assembly, the connector assembly of the stimulator assembly including at least a first connector and a second connector configured to receive at least a portion of the first snap-fit connector and the second snap-fit connector, respectively, of the electrode assembly.

4. The apparatus of claim 1, wherein the housing is configured to substantially maintain the stimulus generator in electrical communication with an electrical pathway coupled to a substrate of the stimulator assembly, the electrical pathway electrically couples the stimulus generator to each of the electrode and the battery.

5. The apparatus of claim 1, wherein the electrode assembly is configured to support the stimulator assembly with respect to the bodily tissue when the stimulator assembly is removably coupled to the electrode assembly and the electrode assembly is adhered to the bodily tissue.

6. The apparatus of claim 1, wherein the electrode assembly is shaped to conform to a predetermined anatomical location, the predetermined anatomical location including a joint.

7. The apparatus of claim 1, wherein the electrode assembly includes a first portion having a curvature configured to be disposed about at least a first portion of a predetermined anatomical location, the electrode assembly includes a second portion having a curvature configured to be disposed about at least a second portion of the predetermined anatomical location.

8. The apparatus of claim 1, wherein at least a portion of the electrode assembly has at least one of a C-shaped curvature or an L-shaped curvature configured to be disposed about a predetermined anatomical location.

9. The apparatus of claim 1, wherein the electrode assembly has an outer perimeter profile in the shape of one of an X, T, or C.

10. The apparatus of claim 1, wherein the electrode assembly is shaped to conform to a predetermined anatomical location, the predetermined anatomical location including a lower back of a user.

11. The apparatus of claim 1, wherein at least one electrode of the plurality of electrodes is a hydrogel electrode, the flexible substrate of the electrode assembly further including a conductive region configured to be electrically coupled to the electrical circuit and a plurality of nonconductive regions configured to facilitate retention of the hydrogel electrode with respect to the second surface of the substrate.

12. The apparatus of claim 1, wherein the stimulator assembly includes a connector assembly configured to be removably coupled to the connector assembly of the electrode assembly such that the stimulator assembly is coupled to the electrode assembly in a predetermined orientation.

13. An apparatus, comprising:

a stimulator assembly including a stimulus generator and a power source at least partially disposed in a housing, the stimulator assembly including a connector assembly; and

an electrode assembly removably coupleable to the stimulator assembly, the electrode assembly including a flexible substrate, a plurality of electrodes, and a plurality of connectors, the plurality of connectors of the electrode assembly including at least two snap-fit connectors extended from a first surface of the flexible substrate, the at least two snap-fit connectors of the plurality of connectors configured to be received by respective complementary connectors of the connector assembly of the stimulator assembly when the electrode assembly is removably coupled to the stimulator assembly such that the stimulator assembly is retained to and supported by the electrode assembly by the coupling of the first connector assembly and the second connector assembly and such that the stimulator assembly is electrically coupled with the electrode assembly via the at least two snap-fit connectors, a first snap-fit connector of the at least two snap-fit connectors configured to form a first electrical connection with the stimulator assembly when the first snap-fit connector is received by a first complementary connector of the connector assembly of the stimulator assembly, a second snap-fit connector of the at least two snap-fit connectors configured to form a second electrical connection, different from the first electrical connection, with the stimulator assembly when the second snap-fit connector is received by a second complementary connector of the connector assembly of the stimulator assembly, the plurality of electrodes being disposed on a second surface of the flexible substrate different from the first surface, the plurality of electrodes configured to adhere to a bodily tissue and to convey an electric current produced by the stimulus generator to at least a portion of the bodily tissue.

14. The apparatus of claim 13, wherein the electrode assembly is shaped to conform to a predetermined anatomical location, the predetermined anatomical location including a joint.

15. The apparatus of claim 13, wherein the electrode assembly includes a first portion having a curvature configured to be disposed about at least a first portion of a predetermined anatomical location, the electrode assembly includes a second portion having a curvature configured to be disposed about at least a second portion of the predetermined anatomical location.

16. The apparatus of claim 13 wherein at least a portion of the electrode assembly has a C-shaped curvature or an L-shaped curvature configured to be disposed about a predetermined anatomical location.

17. The apparatus of claim 13, wherein the electrode assembly is shaped to conform to a predetermined anatomical location, the predetermined anatomical location including a lower back of a user.

18. The apparatus of claim 13, wherein the plurality of electrodes includes a hydrogel electrode, the flexible substrate of the electrode assembly further including a conductive region configured to be electrically coupled to the electrical circuit and a plurality of nonconductive regions configured to facilitate retention of the hydrogel electrode with respect to the second surface of the substrate.

19. The apparatus of claim 13, wherein the electrode assembly includes a tab configured to facilitate removal of the electrode assembly from the bodily tissue.