Method, Surgical Kit and Device for Treating Glaucoma

• US 20130184631A1
• Filed: 01/12/2012
• Published: 07/18/2013
• 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
• Granted Patent: US 9,101,444 B2
• Time in Patent Office: Days
• US Class Current: 604/8
• 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 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 including a flexible tube and tissue sealing means, wherein said tube defines a duct for diverting aqueous humor from the anterior chamber, said tube having a proximal end and distal end opposite one another and a second outer surface having a second maximal cross-sectional dimension that is less than said first maximal cross-sectional dimension, and wherein said tissue sealing means includes at least one element that is spaced apart from said proximal and distal ends of said tube, said at least one element extending radially outward beyond said second outer surface of said tube and having a third maximal cross-sectional dimension that is greater than said first maximal cross-sectional dimension in order to form a seal between the tissue and said at least one element.

2. A kit according to claim 1, wherein:

said second maximal cross-sectional dimension of said at least one element is defined by at least one blunt surface.

3. A kit according to claim 1, wherein:

said at least one element has a tapered distal portion.

4. A kit according to claim 1, 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.

5. A kit according to claim 4, wherein:

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

6. A kit according to claim 4, wherein:

said first and second tabs are generally planar in form and lie in a common plane that extends transverse to the central axis of the tube.

7. A kit according to claim 6, wherein:

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

8. A kit according to claim 4, wherein:

said first and second tabs each have a respective tapered distal portion.

9. 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.

10. A kit according to claim 9, wherein:

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

11. A kit according to claim 10, wherein:

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

12. A kit according to claim 1, wherein:

said tube is realized from a homogenous polymeric material.

13. A kit according to claim 1, wherein:

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

14. A kit according to claim 13, 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.

15. 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.

16. A kit according to claim 15, 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.

17. 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.

18. A kit according to claim 1, wherein:

said needle body has a bent configuration.

19. 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.

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

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

providing an aqueous humor drainage device including a flexible tube and tissue sealing means, wherein said tube defines a duct for diverting aqueous humor from the anterior chamber, said tube having a proximal end and distal end opposite one another and a second outer surface having a second maximal cross-sectional dimension that is less than said first maximal cross-sectional dimension, and wherein said tissue sealing means includes at least one element that is spaced apart from said proximal and distal ends of said tube, said at least one element extending radially outward beyond said second outer surface of said tube and having a third maximal cross-sectional dimension that is greater than said first maximal cross-sectional dimension; and

inserting the aqueous humor drainage device into the passage such that the distal end of the tube lies in the anterior chamber of the eye and the tissue sealing means is disposed in the passage and forms a seal between the tissue and the device and aqueous humor drains from the anterior chamber.

21. A method according to claim 20, wherein:

said second maximal cross-sectional dimension of said at least one element is defined by at least one blunt surface.

22. A method according to claim 20, wherein:

said at least one element has a tapered distal portion that facilitates insertion of the tissue sealing means into the passage.

23. 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.

24. A method according to claim 23, wherein:

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

25. A method according to claim 23, wherein:

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

26. A method according to claim 23, wherein:

said first and second tabs each have a respective tapered distal portion.

27. A method according to claim 23, wherein:

said first and second tabs are generally planar in form and lie in a common plane that extends transverse to the central axis of the tube.

28. 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.

29. A method according to claim 28, wherein:

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

30. A method according to claim 29, wherein:

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

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

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

32. A method according to claim 31, wherein:

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

33. 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.

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

inserting a device into the 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.

35. A method according to claim 34, wherein:

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

36. A method according to claim 34, 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 passage defined by the needle body, and said device is cut distally from the tab while positioned within the passage to leave behind the distal portion of the conduit within to the passage.

37. An implantable device for treatment of elevated ocular pressure within the anterior chamber of the eye, the device comprising:

a flexible tube and tissue sealing means, wherein said tube defines a duct for diverting aqueous humor from the anterior chamber, said tube having a proximal end and distal end opposite one another and an outer surface having a first maximal cross-sectional dimension, and wherein said tissue sealing means includes at least one element that is spaced apart from said proximal and distal ends of said tube, said at least one element extending radially outward beyond said outer surface of said tube and having a second maximal cross-sectional dimension greater than said first maximal cross-sectional dimension, wherein said second maximal cross-sectional dimension is defined by at least one blunt surface.

38. A device according to claim 37, wherein:

said at least one blunt surface has a cross-sectional oblong profile.

39. A device according to claim 37, wherein:

said at least one blunt surface has a cross-sectional profile of an ellipse or a circle.

40. A device according to claim 37, wherein:

said at least one element has a tapered distal portion.

41. A device according to claim 37, 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 second maximal cross-sectional dimension is defined by maximal distance between said first outer edge and said second outer edge.

42. A device according to claim 37, wherein:

said first maximal cross-sectional dimension is no more than 0.4 mm; and

.

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

43. A device according to claim 37, wherein:

said device is a unitary molded part realized from polymeric material 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

44. A device according to claim 43, wherein:

the polymeric material for at least a portion of said device is loaded with at least one therapeutic agent.