Dual blade ophthalmologic surgery device

• US 10,888,460 B2
• Filed: 09/25/2017
• Issued: 01/12/2021
• Est. Priority Date: 06/10/2003
• Status: Active Grant

• Current Assignee: Microsurgical Technology Incorporated (Halma PLC)
• Original Assignee: Microsurgical Technology Incorporated (Halma PLC)
• Inventors: Sorensen, John T., Mittelstein, Michael, Mirhashemi, Soheila
• Primary Examiner(s): Weisberg, Amy R
• Application Number:
  US15/714,909
• Publication Number:
  US 20180125712A1
• Time in Patent Office: 1,205 Days
• Field of Search: 606107, 606166, 606170, 606184, 606185, 600566-567, 30304-305, 30287
• CPC Class Codes: A61B 17/320016 Endoscopic cutting instruments, e.g. arthroscopes, resectoscopes A61B10/0233, A61B17/29, A61B17/3207 take precedence
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2018/00083 low, i.e. electrically insulating
• CPC Class Codes: A61B 2018/1497 Electrodes covering only part of the probe circumference
• 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: A61F 9/0079 using non-laser electromagnetic radiation, e.g. non-coherent light or microwaves

Abstract

A dual blade device and method useable for performing an ab interno procedure within a human eye to remove a strip of trabecular meshwork tissue.

Claims

1. A dual blade device useable for performing an ab interno procedure within a human eye to remove a strip of trabecular meshwork tissue, said device comprising:

a handle configured to be grasped by an operator'"'"'s hand;

an elongate probe shaft that extends from the handle along a longitudinal axis to a distal end;

a tip portion that extends along a second longitudinal axis from the distal end of the probe shaft to form an angle of approximately 30 degrees to approximately 90 degrees relative to the longitudinal axis of the shaft, the tip portion being configured to penetrate through the trabecular meshwork tissue and having a transverse width, a top surface, a bottom surface and a terminal end, the transverse width of the tip portion being narrowest at its terminal end;

first and second spaced apart cutting edges configured to simultaneously cut tissue that passes over the top surface of the protruding tip and into contact with the first and second spaced apart cutting edges; and

a top edge that traverses above an area between the first and second spaced apart cutting edges;

wherein;

a) the top surface of the tip portion extends from the terminal end of the tip portion to the first and second spaced apart cutting edges;

b) a distal portion of the probe, inclusive of the tip portion, is sized to pass through an incision formed in the eye;

c) the tip portion is sized to fit within Schlemm'"'"'s Canal of the human eye and, when so positioned, is advanceable through Schlemm'"'"'s Canal with trabecular meshwork tissue passing over its top surface and into contact with the first and second spaced apart cutting edges;

d) the first and second spaced apart cutting edges are formed on generally opposite edges of the distal end of the elongate probe shaft and are separated by a distance D; and

e) the first and second spaced apart cutting edges face towards the second longitudinal axis of the tip portion.

2. A device according to claim 1 wherein the first and second spaced apart cutting edges cut a strip of trabecular meshwork tissue having a width W that is substantially equal to the distance D.

3. A device according to claim 1 useable for cutting a sector of trabecular meshwork tissue having a length of 2 to 10 millimeters.

4. A device according to claim 1 wherein the bottom surface of the blunt protruding tip extends at an angle of approximately 90 degrees relative to the adjacent longitudinal axis of the shaft.

5. A system comprising a device according to claim 1 in combination with a 1.5 mm slit knife for forming said incision in the human eye.

6. A device according to claim 1 wherein the device is manually operable to remove a strip of trabecular meshwork tissue.

7. A device according claim 1 wherein the shaft comprises a tube having at least one lumen.

8. A method for using a device according to claim 1, said method comprising the steps of:

forming an incision in an eye of a patient;

inserting the device through the incision and into an anterior chamber of the eye;

advancing the device across the anterior chamber until the tip portion is positioned within the anterior chamber adjacent to trabecular meshwork tissue;

causing the tip portion to penetrate through the trabecular meshwork and to become positioned within a Schlemm'"'"'s canal of the eye such that the trabecular meshwork tissue is in contact with the top surface of the tip portion;

moving the device to cause the tip portion to advance through the Schlemm'"'"'s Canal such that the trabecular meshwork tissue moves along the top surface of the tip portion and into contact with the first and second spaced apart cutting edges, thereby cutting a strip of the trabecular meshwork tissue.

9. A method according to claim 8 further comprising the step of keeping the anterior chamber filled.

10. A method according to claim 9 wherein the device further comprises an infusion lumen and wherein fluid is infused through the infusion lumen to keep the anterior chamber filled.

11. A method according to claim 8 wherein the eye is a left eye and the incision is formed at approximately a 3 o'"'"'clock position of the eye.

12. A method according to claim 8 wherein the eye is a right eye and the incision is formed at approximately a 9 o'"'"'clock position on the eye.

13. A method according to claim 8 wherein the incision is a corneal incision.

14. A method according to claim 8 wherein the strip of trabecular meshwork tissue that is cut has a length of about 2 to 10 millimeters.

15. A method according to claim 8 further comprising pressurizing the anterior chamber to cause the anterior chamber to deepen.

16. A method according to claim 15 wherein the step of pressurizing the anterior chamber comprises introducing a fluid into the anterior chamber.

17. A method according to claim 16 wherein the device further comprises an infusion lumen and wherein the fluid is introduced through the infusion lumen and into the anterior chamber.

18. A method according to claim 8 further comprising placing a lens on the eye and using the lens to directly visualize the step of advancing the device across the anterior chamber until the tip portion is positioned within the anterior chamber adjacent to trabecular meshwork tissue.