Insertion and removal methods and apparatus for therapeutic devices

• US 10,603,209 B2
• Filed: 06/08/2018
• Issued: 03/31/2020
• Est. Priority Date: 02/03/2012
• Status: Active Grant

• Current Assignee: Forsight Vsion4, Inc., Forsight Vision4, Inc. (Roche Holding AG)
• Original Assignee: Forsight Vision4, Inc. (Roche Holding AG)
• Inventors: de Juan, Jr., Eugene, Campbell, Randolph E., Erickson, Signe, Barrett, Michael S., Skieller, Christina, Batten, David, Doud, Darren
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): Bui, Anh
• Application Number:
  US16/004,085
• Publication Number:
  US 20180289542A1
• Time in Patent Office: 662 Days
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0033 made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/00772 Apparatus for restoration of tear ducts
• CPC Class Codes: A61K 9/0051 Ocular inserts, ocular implants
• CPC Class Codes: A61M 37/0069 Devices for implanting pellets, e.g. markers or solid medicaments for introducing of radioactive sources for interstitial radiation therapy, i.e. brachytherapy A61N5/1027

Abstract

Described herein is an apparatus to insert an implantable therapeutic device into a patient. The apparatus includes a proximal handle and a distal placement portion coupled to the proximal handle and configured to hold the implantable therapeutic device. The distal placement portion includes a first side having a first engagement structure at a distal end of the first side, the first engagement structure configured to surround at least a first portion of a proximal end region of the implantable therapeutic device. The distal placement portion includes a second, opposite side having a second engagement structure at a distal end of the second side, the second engagement structure configured to surround at least a second, opposite portion of the proximal end region of the implantable therapeutic device.

Claims

1. An apparatus to insert an implantable therapeutic device into a patient, the apparatus extending along a longitudinal axis from a proximal end of the apparatus to a distal end of the apparatus, the apparatus comprising:

a proximal handle; and

a distal placement portion coupled to the proximal handle and configured to hold the implantable therapeutic device, the distal placement portion comprising;

a first side having a first engagement structure at a distal end of the first side, the first engagement structure being substantially c-shaped and configured to surround at least a first portion of a proximal end region of the implantable therapeutic device; and

a second, opposite side having a second engagement structure at a distal end of the second side, the second engagement structure being substantially c-shaped and configured to surround at least a second, opposite portion of the proximal end region of the implantable therapeutic device,

wherein each of the first and second engagement structures comprises;

a distal-facing surface;

a proximal-facing surface opposite the distal-facing surface that extends substantially orthogonal to the longitudinal axis of the apparatus; and

an inward-facing protrusion tapering distally towards the distal-facing surface.

2. The apparatus of claim 1, further comprising the implantable therapeutic device, wherein the implantable therapeutic device includes a retention structure at the proximal end region comprising a narrow portion, a shoulder and a proximal extension.

3. The apparatus of claim 2, wherein the inward-facing protrusion and the proximal-facing surface of the first and second engagement structures are shaped and sized to engage a portion of the retention structure.

4. The apparatus of claim 3, wherein each of the inward-facing protrusions is configured to extend into the narrow portion.

5. The apparatus of claim 4, wherein when the inward-facing protrusions extend into the narrow portion, the proximal-facing surface extending substantially orthogonal engages a distal surface of the proximal extension and a distal surface of each protrusion engages the shoulder.

6. The apparatus of claim 2, wherein the distal placement portion further comprises a recess through which a proximal surface of the proximal extension is accessible.

7. The apparatus of claim 6, further comprising at least one guide surface located proximal to the first and second engagement structures and angled obliquely relative to the longitudinal axis from the proximal end towards the distal end of the apparatus.

8. The apparatus of claim 7, wherein the at least one guide surface is configured to support and maintain alignment of a needle extending at an angle oblique to a longitudinal axis of the implantable device prior to penetration of the implantable device by the needle, wherein the longitudinal axis of the implantable device and the longitudinal axis of the apparatus are coaxially aligned.

9. The apparatus of claim 8, wherein the needle includes a connector and wherein the at least one guide surface has a concave shape complimentary to a convex shape of the connector to mate with the connector and maintain alignment of the needle relative to the implantable device.

10. The apparatus of claim 7, wherein the at least one guide surface comprises a plurality of recessed surfaces, each of the plurality of recessed surfaces angled obliquely relative to the longitudinal axis from the proximal end towards the distal end of the apparatus.

11. The apparatus of claim 10, wherein the plurality of recessed surfaces comprises a first proximal guide surface, a first intermediate guide surface and a first distal guide surface on the first side of the distal placement portion and a second proximal guide surface, a second intermediate guide surface and a second distal guide surface on the second side, opposite side of the distal placement portion.

12. The apparatus of claim 10, wherein when the first and second engagement structures are surrounding the proximal end region of the implantable therapeutic device, an upper surface of the implantable therapeutic device remains exposed and external to the apparatus.

13. The apparatus of claim 12, wherein the plurality of recessed surfaces are arranged to provide a visual reference to a user advancing a needle and guide the needle toward the upper surface of the implantable therapeutic device.

14. The apparatus of claim 7, wherein the distal placement portion further comprises a front side and a back side located opposite the front side, wherein the at least one guide surface is located on the front side of the distal placement portion.

15. The apparatus of claim 14, wherein the first engagement structure and the second engagement structure each extends upwards away from the longitudinal axis and away from the at least one guide surface on the front side of the distal placement portion.

16. The apparatus of claim 14, wherein the at least one guide surface on the front side tapers from the proximal end towards the distal end of the apparatus forming a first angle relative to the longitudinal axis, and wherein the back side of the distal placement portion tapers from the proximal end towards the distal end of the apparatus forming a second angle relative to the longitudinal axis, wherein the first angle is different than the second angle.

17. The apparatus of claim 14, wherein the at least one guide surface on the front side has a concave shape and the back side has a substantially convex shape.

18. The apparatus of claim 7, wherein the at least one guide surface has a concave shape to complement a convex shape of a needle connector.

19. The apparatus of claim 1, wherein the proximal handle includes first and second opposing handles extending on opposite sides of the longitudinal axis, wherein the first opposing handle is coupled to a proximal end of the first side and the second opposing handle is coupled to a proximal end of the second side.

20. The apparatus of claim 19, wherein the first and second opposing handles are configured to urge the first side and the second side toward each other to engage the implantable device when the first and second opposing handles move away from the axis and to urge the first side and the second side away from each other to release the implantable device when the first and second opposing handles move toward the axis.

21. The apparatus of claim 19, wherein the first and second opposing handles are configured to urge the first side and the second side toward each other to engage the implantable device when the first and second opposing handles move toward the axis and to urge the first side and the second side away from each other to release the implantable device when the first and second opposing handles move away from the axis.

22. A kit to treat a patient, the kit comprising:

an insertion apparatus of claim 1;

an implantable therapeutic device; and

packaging to contain the insertion apparatus and the implantable therapeutic device.