Subretinal access device

• US 8,425,473 B2
• Filed: 01/23/2009
• Issued: 04/23/2013
• Est. Priority Date: 01/23/2009
• Status: Expired due to Fees

• Current Assignee: iScience Interventional Corporation
• Original Assignee: iScience Interventional Corporation
• Inventors: Ho, Friedrich, Conston, Stanley R., Yamamoto, Ronald K.
• Primary Examiner(s): Mehta, Bhisma
• Application Number:
  US12/359,157
• Publication Number:
  US 20100191176A1
• Time in Patent Office: 1,551 Days
• Field of Search: 604/22, 604/521, 604/118, 604/264, 604/266, 604/267, 604/268, 604/272, 604/276, 604/294, 604/296, 606/107, 606/108, 606/109
• US Class Current: 604/264
• CPC Class Codes: A61B 1/313 for introducing through surgical openings, e.g. laparoscopes
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 3/102 for optical coherence tomography [OCT]
• CPC Class Codes: A61B 3/12 for looking at the eye fundus, e.g. ophthalmoscopes A61B3/13 takes precedence
• CPC Class Codes: A61B 5/0066 Optical coherence imaging
• CPC Class Codes: A61F 2009/00863 Retina
• CPC Class Codes: A61F 2009/00874 Vitreous
• 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 9/008 using laser

Abstract

The invention provides surgical devices that provide access to the sub-retinal space using delicate traction to hold the sensory retina to create and maintain a patent sub-retinal space of sufficient size to introduce and perform treatments on the eye. Such treatments may include the introduction of illumination or imaging agents or tools, surgical tools, the infusion of pharmaceutical or biological agents, and the placement of grafts, transplants or implants and the closure of the site through the delivery of a sealant.

Claims

1. An apparatus for use with an eye comprising:

a first elongated tubular member having a proximal and a distal end and a lumen passing from said proximal end to said distal end wherein said distal end is shaped and dimensioned for access to the tissue of the retina;

a second elongated tubular member having a proximal end and a distal end, disposed within said lumen of said first tubular member, said second tubular member having a passage therethrough from said proximal end to said distal end;

an annular space within the lumen of said first elongated tubular member, annularly surrounding said second elongated tubular member; and

a blocking member disposed within said annular space, said blocking member having a configuration to allow passage of gases and fluids, and to block entry of tissues into said first elongated tubular member through said annular space with a blocking member distal end that extends beyond said annular space at the distal end of said first elongated tubular member to prevent injury to tissue within the eye by being caused to compress and retract into the distal end of said first elongated tubular member upon reduction of pressure within said annular space;

the distal end of said second elongated tubular member having a pointed tip;

said distal end of said first elongated tubular member being open-ended and adapted to seal upon placement from within the eye in contact of said distal end of said first elongated tubular member with the surface of a tissue layer and upon reduction of pressure within said annular space to allow said pointed tip of said second elongated tubular member to pierce said tissue layer, whereby upon withdrawal of said first elongated tubular member sealed to said tissue layer, said tissue layer detaches from other tissues underlying said tissue layer to form a pocket under said tissue layer accessible to penetration into said pocket by the pointed tip of said second elongated tubular member through said tissue layer without damage to said underlying other tissues.

3. The apparatus according to claim 1 or 2 wherein said passage in said second elongated tubular member is in communication with a device for introducing fluids, suspensions, sealants, adhesives, viscous solids or gases, or aspirating fluids, suspensions, viscous solids or gases, through said passage.

4. The apparatus according to claim 3 wherein said second elongated tubular member comprises a polymer.

5. The apparatus according to claim 4 wherein said polymer comprises a polyimide.

6. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering a sealant in the form of autologous blood.

7. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering a sealant in the form of fibrin glue.

8. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering a biocompatible synthetic adhesive.

9. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering liquids through said passage.

10. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering tissues through said passage.

11. The apparatus according to claim 10 wherein said tissues comprise cellular grafts.

12. The apparatus according to claim 10 wherein said tissues comprise retinal pigment epithelial tissues.

13. The apparatus according to claim 10 wherein said tissues comprise sensory retina tissues.

14. The apparatus according to claim 10 wherein said tissues comprise stem cells.

15. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering pharmaceutical agents through said passage.

16. The apparatus according to claim 3 wherein said device in communication with said passage is capable of a delivering biologic agent through said passage.

17. The apparatus according to claim 16 wherein said biologic agent comprises a radionuclide.

18. The apparatus according to claim 16 wherein said biologic agent comprises a gene therapy product.

19. The apparatus according to claim 3 wherein said device in communication with said passage is capable of delivering gases through said passage.

20. The apparatus according to claim 3 wherein said device in communication with said passage is capable of aspirating liquids through said passage.

21. The apparatus according to claim 3 wherein said device in communication with said passage is capable of aspirating gases through said passage.

22. The apparatus according to claim 1 or 2 wherein said annular space in said first elongated tubular member is in communication with a device for introducing fluids, suspensions, viscous solids or gases, or aspirating fluids, suspensions, viscous solids or gases, through said passage.

23. The apparatus according to claim 1 or 2 wherein the distal end of said second elongated tubular member is adapted to extend beyond the open distal end of said first elongated tubular member.

24. The apparatus according to claim 23 wherein said second elongated tubular member is adapted to extend beyond the open distal end of said first elongated tubular member by about 0.0015 inch to about 0.125 inch.

25. The apparatus according to claim 1 or 2 wherein said second elongated tubular member is slidably disposed within said first elongated tubular member.

26. The apparatus according to claim 25 wherein said second elongated tubular member is retractable into the lumen of said first elongated tubular member.

27. The apparatus according to claim 1 or 2 wherein said first or second elongated tubular member comprises a metal.

28. The apparatus according to claim 27 wherein said metal comprises stainless steel.

29. The apparatus according to claim 27 wherein said second elongated tubular member comprises a nickel-titanium alloy.

30. The apparatus according to claim 1 or 2 wherein said passage accommodates a surgical instrument or tool.

31. The apparatus according to claim 30 wherein said tool comprises an imaging instrument.

32. The apparatus according to claim 31 wherein said imaging instrument comprises an endoscope.

33. The apparatus according to claim 30 wherein said instrument comprises a microsurgical instrument.

34. The apparatus according to claim 30 wherein said instrument or tool is used for removal of blood clots from tissues or vessels.

35. The apparatus according to claim 30 wherein said instrument comprises a fiber optic instrument.

36. The apparatus according to claim 35 wherein said fiber optic instrument is an imaging instrument.

37. The apparatus according to claim 35 wherein said fiber optic instrument is adapted to deliver energy at a target site.

38. The apparatus according to claim 37 wherein said fiber optic instrument is adapted to deliver laser energy for ablation of tissues or vessels.

39. The apparatus according to claim 37 wherein said fiber optic instrument is adapted to deliver radio frequency energy for ablation of tissues or vessels.

40. The apparatus according to claim 1 or 2 wherein said first elongated tubular member is suitably sized to pass through a sclerostomy port.

41. The apparatus according to claim 1 or 2 wherein the distal end of said second elongated tubular member is shaped and dimensioned for access to the tissue of the retinal pigment epithelium.

42. The apparatus according to claim 1 or 2 wherein the distal end of said second elongated tubular member is shaped and dimensioned for access to the tissue of the sub-retinal space.

2. An apparatus for use with an eye comprising:

a first elongated tubular member having a proximal and a distal end and a lumen passing from said proximal end to said distal end wherein said distal end is shaped and dimensioned for access to the tissue of the retina;

a second elongated tubular member having a proximal end and a distal end, disposed within said lumen of said first tubular member, said second tubular member having a passage therethrough from said proximal end to said distal end;

an annular space within the lumen of said first elongated tubular member, annularly surrounding said second elongated tubular member; and

a blocking member disposed within said annular space, said blocking member having a configuration to allow passage of gases and fluids, and to block entry of tissues into said first elongated tubular member through said annular space upon reduction of pressure within said annular space with a blocking member distal end that is disposed flush to the distal end of said first elongated tubular member;

the distal end of said second elongated tubular member having a pointed tip;

said distal end of said first elongated tubular member being open-ended and adapted to seal upon placement from within the eye in contact of said distal end of said first elongated tubular member with the surface of a tissue layer and upon reduction of pressure within said annular space to allow said pointed tip of said second elongated tubular member to pierce said tissue layer, whereby upon withdrawal of said first elongated tubular member sealed to said tissue layer, said tissue layer detaches from other tissues underlying said tissue layer to form a pocket under said tissue layer accessible to penetration into said pocket by the pointed tip of said second elongated tubular member through said tissue layer without damage to said underlying other tissues.