Delivery of implantable neurostimulators

• US 9,861,812 B2
• Filed: 12/03/2013
• Issued: 01/09/2018
• Est. Priority Date: 12/06/2012
• Status: Active Grant

• Current Assignee: BlueWind Medical Ltd.
• Original Assignee: BlueWind Medical Ltd.
• Inventors: Gross, Yossi, Oron, Gur, Ronen, Shlomi, Eytan, Bar, Sohn, Zev, Lore, Rami, Neeman, Danny
• Primary Examiner(s): Koharski, Christopher D
• Assistant Examiner(s): Patel, Natasha
• Application Number:
  US14/649,873
• Publication Number:
  US 20150335882A1
• Time in Patent Office: 1,498 Days
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: A61N 1/0551 Spinal or peripheral nerve electrodes
• CPC Class Codes: A61N 1/0556 Cuff electrodes
• CPC Class Codes: A61N 1/0558 Anchoring or fixation means therefor
• CPC Class Codes: A61N 1/36017 with leads or electrodes penetrating the skin
• CPC Class Codes: A61N 1/37205 Microstimulators, e.g. implantable through a cannula

Abstract

Apparatus is provided, comprising an implant-storage member (24), configured to be percutaneously advanced to a tissue (10) of a subject, and shaped to define (a) a space (26) that is configured to house an implant (22) configured to apply a current to at least the tissue, (b) an opening (28) through which the implant is deliverable to the tissue, and (c) at least one window (30), configured such that, while the implant is disposed within the space and the implant-storage member is disposed in the tissue, the window facilitates flow of the current therethrough from the implant to the tissue; and a delivery manipulator (34), reversibly couplable to the implant, and configured to facilitate delivery of the implant through the opening. Other embodiments are also described.

Claims

1. Apparatus, comprising:

an implant, comprising an implant body and at least one electrode disposed on the implant body; and

a hollow needle, shaped to define a space that is dimensioned to house the implant, and configured to be percutaneously advanceable into tissue of a subject while the implant is disposed within the space,

wherein;

the apparatus is configured, while (a) the at least one electrode is disposed within the space, and (b) the hollow needle is disposed within the tissue, (i) to place the at least one electrode in electrical contact with the tissue, and (ii) to apply an application of current via the at least one electrode to the tissue,

the implant is deployable from the space, via an opening defined by the hollow needle, subsequently to the application of current by the implant to the tissue, and

the hollow needle is percutaneously withdrawable from the tissue (i) subsequently to deployment of the implant from the space, and (ii) such that the implant remains in the tissue.

2. The apparatus according to claim 1, wherein the hollow needle is shaped to define at least one window, configured such that, while the implant is disposed within the space and the hollow needle is disposed in the tissue, the electrical contact is via the window, and the window facilitates flow of the current therethrough between the at least one electrode and the tissue.

3. The apparatus according to claim 2, further comprising a delivery manipulator, reversibly couplable to the implant, and configured to facilitate deployment of the implant through the opening by remaining stationary with respect to the tissue while the hollow needle is withdrawn proximally with respect to the tissue.

4. The apparatus according to claim 3, wherein the hollow needle:

has a proximal end,

has a distal end that defines the opening, and

has a lateral wall that defines the window between the proximal end and the distal end.

5. The apparatus according to claim 1, further comprising a longitudinal member:

having a distal end configured to be percutaneously advanced into the subject while coupled to the implant,

having a proximal end configured to be secured to a skin surface of the subject (1) while the distal end of the longitudinal member remains coupled to the implant within the subject, and (2) for a duration of at least 1 day, and

being configured to move the implant within the subject by being moved.

6. The apparatus according to claim 1, wherein:

the implant comprises at least two electrodes,

the hollow needle is shaped to define at least two windows, and

the implant is configured to be disposed within the space such that each of the electrodes is aligned with a respective window of the at least two windows.

7. The apparatus according to claim 1, wherein:

the implant body has a proximal end and a distal end, and a longitudinal axis between the proximal end and the distal end;

the implant comprises at least one distal anchor, coupled to the implant body, and configured to inhibit movement of the implant body through the tissue in a distal direction more than in a proximal direction; and

at least one proximal anchor, coupled to the implant body, disposed proximally from the distal anchor, and configured to inhibit movement of the implant body through the tissue in the proximal direction more than in the distal direction.

8. The apparatus according to claim 7, wherein:

the distal anchor comprises at least one barb that protrudes, in the distal direction, at a nonzero angle with respect to the longitudinal axis of the implant body, and

the proximal anchor comprises at least one barb that protrudes, in the proximal direction, at a nonzero angle with respect to the longitudinal axis of the implant body.

9. The apparatus according to claim 8, wherein:

each of the anchors has a constrained state and an unconstrained state,

each of the anchors is configured such that the nonzero angle of the barb of each anchor is smaller in the constrained state of the anchor than in the unconstrained state of the anchor.

10. The apparatus according to claim 9, wherein:

the implant is bidirectionally movable through the opening,

the hollow needle is configured (i) to constrain each of the anchors in the respective constrained state thereof while the respective anchor is disposed within the space, and (ii) to move the distal anchor into the constrained state thereof when the distal anchor is moved through the opening into the space; and

the apparatus further comprises a delivery manipulator, reversibly couplable to the implant, and configured to facilitate bidirectional movement of the implant through the opening.

11. A method, comprising:

percutaneously placing an implant within tissue of a subject while the implant is disposed within a lumen of a hollow needle, the implant including at least one electrode;

while the electrode remains disposed within the lumen, activating the implant to apply current to the tissue; and

subsequently to the application of current by the implant, deploying the implant from the hollow needle; and

subsequently, withdrawing the hollow needle from the subject while the implant remains within the tissue.

12. The method according to claim 11, wherein:

the application of current is a first application of current,

the method further comprises;

measuring a physiological response of the subject to the first application;

in response to the measured physiological response to the first application, repositioning the implant in the tissue while the implant remains disposed within the lumen; and

measuring a physiological response of the subject to a second application of current applied, while the implant is disposed within the lumen, by the implant to the tissue, and

deploying the implant from the hollow needle comprises deploying the from the hollow needle in response to the measured physiological response to the second application.

13. The method according to claim 11, wherein the hollow needle is shaped to define a window in a lateral wall of the hollow needle, the lateral wall circumscribing the lumen, and wherein placing the implant comprises placing the implant such that the implant is aligned, within the lumen, with the window, such that the application of current is applied by the implant to the tissue via the window.

14. The method according to claim 13, wherein the window is a first window, the implant includes a first electrode and a second electrode on an outer surface of the implant, the hollow needle is shaped to define a second window in the lateral wall, and wherein placing the implant comprises placing the such that the first and second electrodes are aligned, within the lumen, with the first and second windows, respectively, such that the application of current is applied by the first and second electrodes to the tissue via the first and second windows.

15. The method according to claim 11, wherein the implant includes (i) an implant body having a distal end and a proximal end, (ii) an expandable distal anchor, (iii) at least two electrodes disposed on the implant body, and (iv) an expandable proximal anchor disposed proximally to the distal anchor and to the electrodes, and wherein the method further comprises:

subsequently to the step of placing, putting the implant into a partially-exposed state (a) in which (i) the distal anchor is exposed from the lumen, and is expanded;

(ii) the at least two electrodes are exposed from the lumen, and (iii) the proximal anchor remains disposed within the lumen, and (b) such that the application of current is applied while the implant is in the partially-exposed state.

16. The method according to claim 15, wherein putting the implant into the partially-exposed state comprises putting the implant into the partially-exposed state in which the distal anchor (i) is expanded, and (ii) inhibits movement of the body through the tissue in a distal direction more than in a proximal direction.

17. The method according to claim 15, wherein:

the application of current is a first application of current,

the method further comprises;

measuring a physiological response of the subject to the first application;

in response to the measured physiological response to the first application, repositioning the implant in the tissue; and

measuring a physiological response of the subject to a second application of current applied by the repositioned implant, and

deploying the implant from the hollow needle comprises deploying the from the hollow needle (i) in response to the measured physiological response to the second application, and (ii) such that the proximal anchor expands.

18. The method according to claim 17, wherein deploying the implant comprises exposing the proximal anchor from the lumen such that the proximal anchor (i) expands, and (ii) inhibits movement of the implant body through the tissue in a proximal direction more than in a distal direction.

19. The method according to claim 17, wherein repositioning the implant comprises (i) returning the electrodes and the distal anchor into the lumen (ii) subsequently repositioning the implant and the hollow needle, and (iii) subsequently returning the implant to the partially-exposed state.

20. The method according to claim 17, wherein repositioning the implant comprises moving the hollow needle and the implant proximally while the implant remains in the partially-exposed state.