IP Library Granted Patent US 10,925,639
Granted Patent B2
US 10,925,639 · App. 15/172,132 · Granted Feb 23, 2021

Implant placement and removal systems

Inventors: Jay S. Smith (Wellesley Hills, MA); Michael R. Cole (Stratham, NH); James M. Sellers (Eliot, ME); Scott D. Lautenbach (San Mateo, CA); Amy K. Whitson (Columbus, OH); Matthew Weber (Berkley, MA)
Assignee: Intarcia Therapeutics, Inc.
A61B17/3468A61B17/3403A61B17/3494A61B17/50A61B17/28A61B17/282A61B17/2833A61B2017/2808A61B2017/2837A61B2017/2845A61B2017/3407A61B2090/0811A61M5/425A61M19/00A61M37/0069
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Quick Facts
Patent No.
US 10,925,639
App. No.
15/172,132
Granted
Feb 23, 2021
Kind
B2
Abstract

Devices, methods, and systems are provided for placing an implant into a patient and removing it therefrom.

Claims (55)

1. A system for placing an implant, comprising:

a placement tool comprising

a handle portion, and

a placement cannula having a length, a proximal end arranged near the handle portion and a distal end opposite the proximal end, the placement cannula configured to deliver the implant within a tissue of a patient via an incision in the skin of the patient at an implantation site; and

a placement guide comprising

a first surface having a contact face and an opposite non-contact face, the first surface contact face configured to be disposed in contact with a surface of the skin of the patient at the implantation site, and

a pilot-tube member projecting from the contact face of the first surface and configured to be disposed in contact with the surface of the skin of the patient at the implantation site, the pilot-tube member defining a tube therethrough, the tube comprising a proximal end configured to receive the distal end of the placement cannula, a distal end spaced apart from the proximal end of the tube at a first distance, and a longitudinal central axis arranged relative to the first surface at either or both of a second distance and an angle;

wherein the placement guide is configured to guide the placement cannula within the tissue of the patient at the implantation site to effect implantation of the implant at a predetermined placement depth beneath an outer surface of the skin of the patient at the implantation site beneath the first surface contact face such that opposite ends of the implant are placed at equal depths, and

wherein the placement cannula is movable relative to the placement guide, and wherein the placement cannula is movable either within or adjacent to the pilot-tube member.

2. The system of claim 1 , wherein at least one of the first distance, the second distance, and the angle of the longitudinal central axis of the tube relative to the first surface of the placement guide are configured to orient the longitudinal axis in order to guide the placement cannula for the delivery of the implant at the predetermined placement depth.

3. The system of claim 1 , wherein the predetermined placement depth is 0.5 mm to 4.5 mm beneath the outer surface of the skin of the patient.

4. The system of claim 1 , wherein the placement guide further comprises a visualization window or opening, wherein the visualization window or opening extends along a length and a width of the placement guide and is configured to allow visual observation and/or palpation or touch of an area of an outer surface of skin around the implantation site.

5. The system of claim 1 , wherein the placement guide further comprises a visualization opening, wherein the visualization opening extends along a length and a width of the placement guide and is configured to allow visual observation and palpation or touch of an area of an outer surface of skin around the implantation site.

6. The system of claim 1 , wherein the implant is an osmotic pump.

7. The system of claim 1 , configured to permit clockwise and counterclockwise rotation of the placement cannula within the tube and relative to the longitudinal central axis of the tube.

8. A method for placing an implant, comprising:

providing a placement system according to claim 1 .

9. The method of claim 8 , further comprising at least one of:

loading the implant into the distal end of the placement cannula;

creating an incision in the skin at an implantation site;

arranging the placement guide at the implantation site, such that the distal end of the tube is aligned with the incision;

inserting the distal end of the loaded placement cannula in the proximal end of the tube;

moving the placement cannula relative to the pilot-tube member until at least a part of the handle portion is proximate the proximal end of the tube such that the distal end of the placement cannula is guided farther into the incision and into the tissue beneath and/or adjacent the incision;

releasing the implant from the placement cannula;

removing the placement cannula from the skin of the patient; and

removing the placement guide from the skin of the patient.

10. The method of claim 9 , wherein the placement cannula is guided into the incision and into the tissue with rotation of the handle portion, thereby resulting in rotation of the placement cannula within the pilot-tube member.

11. The method of claim 9 , wherein prior to creating the incision, the method further comprises at least one of:

cleaning the skin at the implantation site;

marking the skin for making the incision; and

injecting a local anesthetic in a vicinity of the marked skin.

12. The method of claim 9 , wherein after release and/or removal of the placement cannula, and/or removal of the placement guide, the method further comprises at least one of:

cleaning the incision;

applying pressure to the incision;

applying an adhesive to at least one side of the incision; and

closing the incision.

13. The method of claim 9 , wherein the implant is released from the placement cannula at the predetermined depth.

14. The method of claim 13 , wherein the predetermined depth is between 0.5 mm to 4.5 mm beneath the outer surface of the skin of the patient.

15. The method of claim 14 , wherein opposite ends of the implant are placed at equal depths, resulting in a level placement of the implant with respect to the outer surface of the skin of the patient.

16. The method of claim 15 , wherein opposite ends of the implant are placed at a predetermined depth that is within 0.3 mm of one another.

17. The system of claim 1 , wherein the placement cannula is movable within and relative to the handle portion.

18. A placement guide for use with a placement tool, the placement guide comprising:

a first surface having a contact face and an opposite non-contact face, the first surface contact face configured to be disposed in contact with a surface of the skin of a patient at the implantation site; and

a pilot-tube member projecting from the contact face of the first surface and configured to be disposed in contact with the surface of the skin of the patient at the implantation site, the pilot-tube member defining a tube therethrough, the tube comprising a proximal end configured to receive a distal end of a placement cannula of the placement tool for delivering an implant to tissue, a distal end spaced apart from the proximal end of the tube at a first distance, and a longitudinal axis therethrough from the proximal end to the distal end,

wherein the longitudinal axis is arranged relative to the first surface at either or both of a second distance and an angle,

wherein at least one of the second distance or the angle of the placement guide is configured to orient the longitudinal axis in order to guide the placement cannula of the placement tool within the tissue of the patient at the implantation site to effect implantation of the implant beneath an outer surface of the skin of the patient at the implantation site beneath the first surface contact face such that opposite ends of the implant are placed at equal depths, and

wherein the pilot-tube member is configured to permit rotation of the placement cannula within the pilot-tube member.

19. The placement guide of claim 18 , further comprising a visualization window or opening that extends along a length and a width of the first surface and configured to enable visual observation and/or palpation or touch of an area of the outer surface of skin around the implantation site.

20. The placement guide of claim 19 , wherein the visualization window or opening has a length that extends beyond a tip of the cannula when the cannula is inserted into, and fully extended through, the tube.

21. The placement guide of claim 18 , wherein the predetermined placement depth is from 0.5 mm to 4.5 mm beneath the outer surface of the skin of the patient.

22. The placement guide of claim 18 , wherein the pilot-tube member is configured to receive and guide the placement cannula into tissue.

23. The placement guide of claim 18 , wherein the placement guide is made from a material that is translucent or clear.

24. The placement guide of claim 18 , wherein the tube is configured at an incline relative to a level underside of the placement guide.

25. The placement guide of claim 18 , wherein the placement guide cannot readily be flexed or bent, length-wise or width-wise, by a user.

26. The placement guide of claim 18 , configured to permit clockwise and counterclockwise rotation of the placement cannula within the tube and relative to the longitudinal central axis of the tube.

Assignments (5)
RELEASE OF SECURITY INTEREST Recorded Apr 17, 2020
From: MIDCAP FINANCIAL TRUST, AS AGENT
To: INTARCIA THERAPEUTICS, INC.; INTARCIA IRELAND LIMITED
Reel/Frame 052433/0001 →
RELEASE OF SECURITY INTEREST Recorded Jan 29, 2020
From: BAUPOST PRIVATE INVESTMENTS BVIV-3, L.L.C. AS COLLATERAL AGENT
To: INTARCIA THERAPEUTICS, INC.
Reel/Frame 051739/0453 →
SECURITY INTEREST Recorded Oct 23, 2019
From: INTARCIA THERAPEUTICS, INC.
To: BAUPOST PRIVATE INVESTMENTS BVIV-3, L.L.C., AS COLLATERAL AGENT
Reel/Frame 050801/0267 →
SECURITY INTEREST Recorded Oct 9, 2019
From: INTARCIA THERAPEUTICS, INC.; INTARCIA IRELAND LIMITED
To: MIDCAP FINANCIAL TRUST, AS AGENT
Reel/Frame 050673/0020 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 22, 2016
From: SMITH, JAY S.; COLE, MICHAEL R.; SELLERS, JAMES M.; LAUTENBACH, SCOTT D.; WHITSON, AMY K.; WEBER, MATTHEW
To: INTARCIA THERAPEUTICS INC.
Reel/Frame 039494/0892 →
Continuity (3)
Provisional Application 62170561 · Jun 3, 2015
Provisional Application 62170994 · Jun 4, 2015
Related Publication 20160354115A1 · Dec 8, 2016