Method, surgical kit and device for treating glaucoma

• US 9,101,444 B2
• Filed: 01/12/2012
• Issued: 08/11/2015
• Est. Priority Date: 01/12/2012
• Status: Active Grant

• Current Assignee: InnFocus, Inc. (Santen Pharmaceutical Company Limited)
• Original Assignee: InnFocus, Inc. (Santen Pharmaceutical Company Limited)
• Inventors: Pinchuk, Leonard
• Primary Examiner(s): Deak, Leslie
• Assistant Examiner(s): WENG, KAI H
• Application Number:
  US13/348,931
• Publication Number:
  US 20130184631A1
• Time in Patent Office: 1,307 Days
• Field of Search: 604/8
• US Class Current: 1/1
• CPC Class Codes: A61F 2009/00891 Glaucoma
• CPC Class Codes: A61F 9/0017 implantable in, or in contact with, the eye, e.g. ocular inserts
• CPC Class Codes: A61F 9/007 Methods or devices for eye surgery
• CPC Class Codes: A61F 9/00736 Instruments for removal of intra-ocular material or intra-ocular injection, e.g. cataract instruments A61F9/008 takes precedence
• 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 2210/0612 Eyes
• 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

Abstract

A surgical kit includes at least one instrument and at least one implant device. The instrument has a needle body used to form a surgical passage through ocular tissue. The device includes a flexible tube that defines a duct for diverting aqueous humor with an outer surface having a maximal cross-sectional dimension that is less than the maximal cross-sectional dimension of the needle body. The device incorporates sealing means including at least one element that define a maximal cross-sectional dimension that is greater that the maximal cross-sectional dimension of the needle body and that are operably disposed within the surgical passage and form a seal between the surrounding ocular tissue and the element(s) as well as fixate the device in the surgical passage. The kit (and devices thereof) can be used as part of a surgical method to divert aqueous humor to a space formed in ocular tissue.

Claims

1. A kit for surgical treatment of elevated ocular pressure within the anterior chamber of the eye, the kit comprising:

an instrument having a needle body for insertion through tissue to define a tissue passage connecting to the anterior chamber, wherein said needle body has a first maximal cross-sectional dimension along its length; and

an aqueous humor drainage device consisting of a flexible tube and first and second tabs,

wherein said tube defines a duct for diverting aqueous humor from the anterior chamber, said tube having a proximal portion defining a cylindrical outer surface and a distal portion defining a cylindrical outer surface, the cylindrical outer surfaces of the proximal portion and the distal portion having a second maximal cross-sectional dimension that is less than said first maximal cross-sectional dimension, and

wherein said first and second tabs are spaced apart from and intermediate the cylindrical outer surfaces of said proximal and distal portions of said tube, said tabs extending in a common plane radially outward beyond the cylindrical outer surfaces of said proximal and distal portions of said tube with a proximal surface and a distal surface, said distal surface having a tapered profile that extends away from the distal portion of said tube toward the proximal portion of said tube, and said tabs having a third maximal cross-sectional dimension that is greater than said first maximal cross-sectional dimension and structured in order to form a seal between the tissue passage and said tabs, said third maximal cross-sectional dimension of said tabs defined by at least one blunt surface formed between the proximal and distal surfaces of each tab.

2. A kit according to claim 1, wherein:

said first and second tabs are mirror images of one another reflected about the central axis of said tube.

3. A kit according to claim 1, wherein:

said first and second tabs are generally planar and extend transverse to the central axis of the tube.

4. A kit according to claim 3, wherein:

said first and second tabs have a maximal thickness no more than the second maximal cross-sectional diameter of the tube.

5. A kit according to claim 1, wherein:

said first maximal cross-sectional dimension is in the range between 0.4 mm and 0.7 mm.

6. A kit according to claim 5, wherein:

said second maximal cross-sectional dimension is no more than 0.4 mm.

7. A kit according to claim 6, wherein:

said third maximal cross-sectional dimension is at least 0.9 mm.

8. A kit according to claim 1, wherein:

said tube is realized from a homogenous polymeric material.

9. A kit according to claim 1, wherein:

said aqueous humor drainage device is a unitary molded part realized from polymeric material.

10. A kit according to claim 9, wherein:

said polymeric material is selected from the group consisting of SIBS material, silicone rubber, a polyolefin polymer, a polyurethane polymer, an acrylic polymer, a fluoropolymer, a polyamide polymer, a hydrogel polymer, a biological based structure, a soft polymer foam material, a porous polymer material, and combinations thereof.

11. A kit according to claim 1, further comprising:

a device including a conduit sized to receive the tube of the aqueous humor drainage device, said conduit having a slot that allows passage of the tube of the aqueous humor drainage device therethrough.

12. A kit according to claim 11, wherein:

said slot extends along a portion of the conduit, wherein a tab is disposed adjacent a proximal end of said slot for positioning of said conduit.

13. A kit according to claim 1, further comprising:

a stylet sized for insertion into the tube of the aqueous humor drainage device in order to position the aqueous humor drainage device.

14. A kit according to claim 1, wherein:

said needle body has a bent configuration.

15. A kit according to claim 1, wherein:

said instrument has a flat blade portion disposed proximally from the needle body, said flat blade portion having two cutting surfaces disposed on opposite sides of the flat blade portion.

16. A kit according to claim 3, wherein:

said first and second tabs decrease in thickness as they radially extend from the central axis of the tube.

17. A kit according to claim 16, wherein:

said first and second tabs have rounded surfaces within the common plane.

18. A kit according to claim 3, wherein:

said first and second tabs have rounded surfaces within the common plane.

19. A kit according to claim 1, wherein:

said first and second tabs are dimensioned to fit simultaneously entirely within the scleral tissue.

20. A method for surgical treatment of elevated ocular pressure of the eye, the method comprising:

providing the instrument having the needle body and the aqueous humor drainage device of the kit of claim 1;

inserting the needle body through tissue to define a tissue passage connected to the anterior chamber of the eye, wherein said needle body has a first maximal cross-sectional dimension along its length; and

inserting the aqueous humor drainage device into the tissue passage such that the distal end of the tube lies in the anterior chamber of the eye and the tabs are disposed in the tissue passage and form a seal between the tissue passage and the device and aqueous humor drains from the anterior chamber through the drainage device.

21. A method according to claim 20, wherein:

said at least one element includes first and second tabs that extend radially from said tube on opposite sides of said tube, said first tab defining a first outer edge, said second tab defining a second outer edge, wherein said third maximal cross-sectional dimension is defined by maximal distance between said first outer edge and said second outer edge.

22. A method according to claim 21, wherein:

said first and second tabs are mirror images of one another reflected about the central axis of the tube.

23. A method according to claim 21, wherein:

said first and second tabs have a maximal thickness no more than the second maximal cross-sectional diameter of the tube.

24. A method according to claim 21, wherein:

said first and second tabs are generally planar and extend transverse to the central axis of the tube.

25. A method according to claim 20, wherein:

said first maximal cross-sectional dimension is in the range between 0.4 mm and 0.7 mm.

26. A method according to claim 25, wherein:

said second maximal cross-sectional dimension is no more than 0.4 mm.

27. A method according to claim 26, wherein:

said third maximal cross-sectional dimension is at least 0.9 mm.

28. A method according to claim 20, further comprising:

using a flat knife to widen a portion of the tissue passage defined by the needle body.

29. A method according to claim 28, wherein:

the needle body and the flat knife are parts of a unitary surgical instrument.

30. A method according to claim 20, wherein:

the aqueous humor drainage device is inserted into the passage defined by the needle using a stylet that is inserted into the tube of the aqueous humor drainage device.

31. A method according to claim 20, further comprising:

inserting a device into the tissue passage defined by the needle body, the device including a conduit sized to receive the tube of the aqueous humor drainage device, said conduit having a slot that allows for passage of the tube of the aqueous humor drainage device therethrough;

inserting the aqueous humor drainage device into the conduit; and

removing the conduit from the passage defined by the needle body while leaving behind the aqueous humor drainage device, whereby the slot of the conduit allows for passage of the tube of the aqueous humor drainage device therethrough during the removing.

32. A method according to claim 31, wherein:

the conduit is placed around a proximal part of the needle body and inserted into the tissue passage defined by the needle body as the tissue passage in formed by a distal part of the needle body.

33. A method according to claim 31, wherein:

said slot extends along a distal portion of the conduit and a tab is disposed adjacent a proximal end of said slot for positioning of the conduit within the tissue passage defined by the needle body, and said device is cut distally from the tab while positioned within the tissue passage to leave behind the distal portion of the conduit within the tissue passage.

34. A method according to claim 21, wherein:

said first and second tabs decrease in thickness as they radially extend from the central axis of the tube.

35. A method according to claim 34, wherein:

said first and second tabs have rounded surfaces within the common plane.

36. A method according to claim 21, wherein:

said first and second tabs have rounded surfaces within the common plane.

37. A method according to claim 20, wherein:

said first and second tabs are positioned simultaneously entirely within the scleral tissue.