Inhibition of implant migration

• US 10,449,374 B2
• Filed: 04/28/2017
• Issued: 10/22/2019
• Est. Priority Date: 11/12/2015
• Status: Active Grant

• Current Assignee: BlueWind Medical Ltd.
• Original Assignee: BlueWind Medical Ltd.
• Inventors: Oron, Gur, Benjamin, Eran, Eytan, Bar, Armoni, Nir, Gross, Yossi
• Primary Examiner(s): Porter, Allen
• Application Number:
  US15/581,390
• Publication Number:
  US 20170224996A1
• Time in Patent Office: 907 Days
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2002/0068 having a special mesh pattern
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2210/0071 thermoplastic
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/0504 Subcutaneous electrodes
• CPC Class Codes: A61N 1/0539 Anchoring of brain electrode systems, e.g. within burr hole
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36057 adapted for stimulating afferent nerves
• CPC Class Codes: A61N 1/36071 Pain
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula
• CPC Class Codes: A61N 1/3756 Casings with electrodes thereon, e.g. leadless stimulators

Abstract

An electrostimulator implant comprises (i) an implant body, the implant being injectable into tissue of a subject along a longitudinal axis of the implant body, (ii) first and second electrodes, disposed on respective first and second portions of the implant body; (iii) circuitry, disposed inside the implant body, and configured to drive the electrodes to apply current to the tissue; and (iv) a mesh. The mesh is configured to serve as an anchor of the implant, is disposed over a third portion of the implant body that is longitudinally between the first and second portions of the implant body, and has a first end and a second end. Each of the ends is fixedly attached to respective first and second sites of the implant body, the respective sites being longitudinally between the first and second electrodes.

Claims

1. Apparatus, comprising:

an electrostimulator implant, comprising;

an implant body, the implant body having a longitudinal axis,

first and second electrodes, disposed on respective first and second portions of the implant body;

circuitry, disposed inside the implant body; and

a mesh;

configured to serve as an anchor of the implant,

disposed circumscribing entirely around a third portion of the implant body that is longitudinally between the first and second portions of the implant body, and

having a first end and a second end, each of the ends being fixedly attached to respective first and second sites of the implant body, the respective sites being longitudinally between the first and second electrodes, and

a percutaneously-advanceable delivery tool comprising a needle,

wherein;

the implant is disposed within the needle;

the needle is configured for intramuscular injection;

the tool is configured to inject the electrostimulator implant by applying a longitudinal force, within the needle, to the implant, causing the implant to become exposed from the needle, and to become implanted within solid tissue of a subject such that the mesh is in circumferential contact with solid tissue surrounding the third portion;

the mesh is configured to inhibit movement of the implant within the solid tissue by;

(i) initially providing mechanical anchoring, and

(ii) promoting tissue growth thereupon; and

the circuitry is configured to neurostimulate the subject by driving the electrodes to apply stimulatory current to the solid tissue.

2. The apparatus according to claim 1, wherein the mesh comprises a tissue-growth scaffold.

3. The apparatus according to claim 1, wherein the mesh is disposed over at least 50 percent of the implant body.

4. The apparatus according to claim 1, wherein the mesh is disposed over at least 70 percent of the implant body.

5. The apparatus according to claim 1, wherein the mesh is disposed over less than 90 percent of the implant body.

6. The apparatus according to claim 1, wherein the mesh comprises polyethylene terephthalate.

7. The apparatus according to claim 1, wherein the mesh comprises a graft material.

8. The apparatus according to claim 1, wherein the mesh comprises braided strands.

9. The apparatus according to claim 1, wherein the mesh is metallic.

10. The apparatus according to claim 1, wherein the mesh comprises a polymer.

11. The apparatus according to claim 1, wherein the mesh is a fabric.

12. The apparatus according to claim 1, wherein the mesh has shape memory.

13. The apparatus according to claim 1, wherein the mesh comprises a plurality of strand segments that each helically curve at least partway around the implant body and the longitudinal axis.

14. The apparatus according to claim 13, wherein the strand segments overlap each other.

15. The apparatus according to claim 13, wherein each strand segment has a first end fixedly attached to the first site of the implant body, and a second end fixedly attached to the second site of the implant body.

16. The apparatus according to claim 13, wherein the implant further comprises a fabric disposed over the plurality of strand segments.

17. The apparatus according to claim 1, wherein the mesh has (i) a delivery state in which the mesh defines a first maximum transverse diameter, and (ii) an implanted state in which the mesh defines a second maximum transverse diameter that is greater than the first transverse diameter.

18. The apparatus according to claim 17, wherein the mesh has shape memory, and is biased to assume the implanted state.

19. The apparatus according to claim 17, wherein the implant body has a body diameter transverse to the longitudinal axis, and the first maximum transverse diameter is 0.1-0.6 mm greater than the body diameter.

20. The apparatus according to claim 17, wherein the second maximum transverse diameter is 0.2-2 mm greater than the first maximum transverse diameter.

21. The apparatus according to claim 20, wherein the second maximum transverse diameter is 0.5-2 mm greater than the first maximum transverse diameter.

22. The apparatus according to claim 17, wherein the tool is configured to apply a force to the mesh, the force driving the mesh toward the implanted state.

23. The apparatus according to claim 17, wherein, while the implant is disposed within the tool, the tool retains the mesh in the delivery state, and when the implant is deployed from the tool, the mesh automatically moves toward the implanted state.

24. The apparatus according to claim 1, wherein the mesh is disposed over at least 50 percent and less than 90 percent of the implant body.