Flow regulating implant, method of manufacture, and delivery device

• US 20010000527A1
• Filed: 12/04/2000
• Published: 04/26/2001
• Est. Priority Date: 11/20/1997
• Status: Active Grant

• Current Assignee: Optonol, Ltd. (Alcon Incorporated)
• Original Assignee: Optonol, Ltd. (Alcon Incorporated)
• Inventors: Yaron, Ira, Yarden, Orit
• Granted Patent: US 6,510,600 B2
• Time in Patent Office: Days
• US Class Current: 604/9
• CPC Class Codes: A61F 9/00781 Apparatus for modifying intraocular pressure, e.g. for glaucoma treatment drainage implants in general A61M27/002
• CPC Class Codes: A61M 27/002 Implant devices for drainage of body fluids from one part of the body to another intraocular A61F9/00781; middle ear A61F11/202
• CPC Class Codes: Y10T 29/49826 Assembling or joining
• CPC Class Codes: Y10T 29/49861 Sizing mating parts during final positional association

Abstract

An implant includes a tube for permitting fluid flow. A flow controlling rod may be inserted within the tube passage. One or more holes around the circumference of the tube may be selectively permanently or temporarily occluded to give desired flow characteristics.

A delivery device for implanting the implant may include a central bore in which a retractable wire is located. The retractable wire penetrates a tube passage of the implant when the implant is attached to the delivery device. A hook on the delivery device prevents the implant from moving down the wire. After the implant is in position in the eye, the retention wire is retracted out of the implant. With the retention wire retracted, the implant is then free to slide away from the hook, allowing the delivery device to be withdrawn, leaving the implant in place.

In a method for manufacturing an implant, two tubes of different diameters are utilized. The smaller tube fits inside the longitudinal bore of the larger tube. When the tubes are cut, the smaller tube forms the tube of the implant and the remaining portions of the larger tube form the retention projection and/or disk of the implant.

Claims

1. A method for manufacturing an implant comprising the steps of:

selecting a first tube having a longitudinal bore and a second tube having a longitudinal bore and dimensioned to fit inside the longitudinal bore of the first tube;

placing the second tube inside the longitudinal bore of the outer tube;

cutting the first tube and the second tube to form the implant.

2. A method for manufacturing an implant as described in

claim 1

wherein at least some of the cutting of the first tube is performed before the second tube is placed inside the longitudinal bore of the first tube.

3. A method for manufacturing an implant as described in

claim 1

wherein at least some of the cutting of the first tube is performed after the second tube is placed inside the longitudinal bore of the first tube.

4. A method for manufacturing an implant as described in

claim 3

wherein the cutting includes simultaneously cutting the outer tube and inner tube along an angled plane at the outlet end of the implant.

5. A method for manufacturing an implant as described in

claim 1

further comprising the step of welding the second tube to the first tube after it is placed in the longitudinal bore of the first tube.

6. A method for manufacturing an implant as described in

claim 1

wherein the portion of the inner tube that remains after completion of the cutting forms an implant shaft and the portions of the outer tube that remain after completion of the cutting form a retention projection and a disk of the implant.

7. An implant for regulating fluid flow comprising:

a tube comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting fluid to flow through the tube passage;

wherein the implant has a flow controlling rod located in the tube passage.

8. An implant according to

claim 7

wherein the flow controlling rod has a circular cross-section.

9. An implant according to

claim 7

wherein the flow controlling rod has a noncircular cross-section.

10. An implant according to

claim 7

wherein the flow controlling rod has an external groove on its outer surface.

11. An implant according to

claim 10

wherein the external groove is helical.

12. An implant according to

claim 7

wherein the flow controlling rod is tapered.

13. An implant according to

claim 7

wherein one of the location or angular orientation of the flow controlling rod within the tube passage is adjustable.

14. An implant according to

claim 7

wherein the flow controlling rod is bendable within the tube passage to regulate flow in accordance with the fluid pressure.

15. An implant according to

claim 7

wherein the flow controlling rod is movable within the tube passage to regulate flow in accordance with the fluid pressure.

16. An implant according to

claim 15

wherein the flow controlling rod is biased by a spring within the tube passage.

17. An implant for regulating fluid flow comprising:

a tube comprising an inlet end, an outlet end, and a tube passage extending between the inlet end and the outlet end for permitting fluid to flow through the tube passage;

wherein the tube has at least one circumferential hole which opens into the tube passage and one or more of the circumferential holes is occluded.

18. An implant according to

claim 17

wherein the occlusion of at least one of the circumferential holes is temporary.

19. An implant according to

claim 18

wherein the temporary occlusion is caused by material in the hole which is later removed.

20. An implant according to

claim 19

wherein the temporary occlusion is caused by an absorbable material located in the hole.

21. An implant according to

claim 19

wherein the temporary occlusion is caused by a material located in the hole which is later removed by one of a tool or laser.

22. An implant according to

claim 17

comprising at least two circumferential holes which opens into the tube passage, wherein at least two of the circumferential holes are located at different distances from the inlet end of the implant and wherein the circumferential holes may be occluded or open to provide the implant with different flow characteristics.

23. A delivery device for implanting an implant, the delivery device comprising:

a handle;

a rodlike instrument having a bore;

a retractable wire located in the bore of the rodlike instrument; and

a retention mechanism including an abutment surface for preventing the implant from moving up the delivery device during implantation and a hook for preventing the implant from moving down the wire during implantation.

24. A delivery device according to

claim 23

wherein the hook prevents movement of the implant in a direction parallel to the wire but permits movement in a direction transverse to the wire, such that when the wire is retracted from a tube passage of the implant, the implant is permitted to slide away from the hook to separate the implant from the delivery device.

25. A delivery device according to

claim 23

wherein the abutment surface has an angle generally corresponding to that of a disk of the implant.