Devices and methods for ocular surgery

• US 10,603,213 B2
• Filed: 01/04/2019
• Issued: 03/31/2020
• Est. Priority Date: 05/04/2017
• Status: Active Grant

• Current Assignee: Carl Zeiss Meditec Cataract Technology Inc. (Carl-Zeiss-Stiftung)
• Original Assignee: Carl Zeiss Meditec Cataract Technology Inc. (Carl-Zeiss-Stiftung)
• Inventors: Clauson, Luke W., Schaller, Michael P., Chamness, Scott, Reese, Brendan
• Primary Examiner(s): David, Shaun L
• Assistant Examiner(s): Lauer, Christina C
• Application Number:
  US16/240,186
• Publication Number:
  US 20190133825A1
• Time in Patent Office: 452 Days
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320024 Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue
• CPC Class Codes: A61B 2017/32006 with a cutting strip, band or chain, e.g. like a chainsaw
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61F 2009/00887 Cataract
• CPC Class Codes: A61F 9/00754 for cutting or perforating the anterior lens capsule, e.g. capsulotomes
• CPC Class Codes: A61F 9/00763 with rotating or reciprocating cutting elements, e.g. concentric cutting needles atherectomy cutting instruments A61B17/3207; endoscopic cutting instruments A61B17/320016

Abstract

Devices, systems, and methods for performing an ophthalmic procedure in an eye are disclosed. The devices include a hand-held portion and a distal, elongate member coupled to the hand-held portion having a lumen operatively coupled to a vacuum source. A drive mechanism operatively coupled to the elongate member is configured to oscillate the elongate member. When in use, the device is configured to aspirate ocular material from the eye through the lumen. The drive mechanism retracts the elongate member with a retraction speed profile and advances the elongate member with an extension speed profile. The retraction speed profile is different from the extension speed profile.

Claims

1. A device for extracting lens material from an eye, the device comprising:

a hand-held portion comprising a proximal, reusable portion releasably coupleable to a distal, disposable portion;

said proximal, reusable portion comprising;

a motor, and

a rotatable coupler for releasably operatively coupling the motor to the distal, disposable portion,

said proximal, reusable portion configured to remain outside of the eye;

said distal, disposable portion comprising;

an elongate member comprising a distal cutting tip and an inner lumen having an open distal end, said elongate member sized and configured to extend through an anterior chamber of the eye and to a capsular bag of the eye, and further wherein in use, the device is configured to aspirate the lens material from the capsular bag of the eye into the inner lumen,

an irrigation lumen coupleable to a source of irrigation fluid,

a plurality of pistons and an equal number of a plurality of cylinders, each of said plurality of pistons housed within a dedicated one of said plurality of cylinders, each of said plurality of cylinders housed within the disposable portion of the hand-held portion and operatively coupled to said inner lumen, and

a rotational cam assembly capable of being rotated by the motor via said rotatable coupler, wherein rotation of said rotational cam assembly causes said plurality of pistons to generate pulses of discontinuous negative pressure within the inner lumen.

2. The device of claim 1, wherein the irrigation lumen comprises an annular space at least in part surrounding said elongate member.

3. The device of claim 2, wherein the distal, disposable portion further comprises an outer tubular portion and at least one outlet opening, said elongate member extending through and beyond a distal portion of said outer tubular portion, said annular space consisting of a space between the outer tubular portion and said elongate member.

4. The device of claim 1, wherein said proximal, reusable portion further comprises a throttle mechanism for varying a speed of the motor, said throttle mechanism operatively coupled to an actuator.

5. The device of claim 1, wherein said rotation of said rotational cam assembly additionally causes reciprocation of said distal cutting tip of said elongate member.

6. The device of claim 5, wherein said reciprocation comprises movement of said distal cutting tip in a distal direction and movement of said distal cutting tip in a proximal direction, and wherein a first speed profile of said movement of said distal cutting tip in said distal direction is different than a second speed profile of said movement of said distal cutting tip in said proximal direction.

7. The device of claim 5, wherein said reciprocation comprises a maximum extension speed and a maximum retraction speed, and further wherein said maximum extension speed of said distal cutting tip is different than said maximum retraction speed.

8. The device of claim 7, wherein said maximum extension speed of said distal cutting tip is greater than said maximum retraction speed.

9. The device of claim 7, wherein said maximum retraction speed is preselected so as to avoid cavitation within the anterior chamber of the eye.

10. The device of claim 5, wherein a frequency of oscillation of said reciprocation is between about 0.5 Hz to 5000 Hz.

11. The device of claim 5, wherein a frequency of oscillation of said reciprocation is ultrasonic.

12. The device of claim 1, wherein said distal, disposable portion further comprises a plurality of one-way inlet valves and a plurality of one-way outlet valves, wherein each of said plurality of cylinders is both downstream of at least one of said plurality of one-way inlet valves with respect to a flow of lens material aspirated into said inner lumen, and upstream of at least one of said plurality of one-way outlet valves with respect to said flow of lens material.

13. The device of claim 12, wherein said one-way inlet valves are duckbill valves, and wherein said one-way outlet valves are ball valves.

14. The device of claim 12, wherein said one-way inlet valves comprise a non-rigid material and said one-way outlet valves comprise a rigid material.

15. The device of claim 14, wherein said non-rigid material is one of semi-compliant or compliant.

16. The device of claim 15, wherein at least one of said proximal, reusable portion and said distal, disposable portion is operatively releasably coupleable to an external vacuum source for providing a level of continuous negative pressure within said lumen.

17. The device of claim 16, wherein said level of continuous negative pressure is less than a level of said discontinuous negative pressure generated by said plurality of pistons.

18. The device of claim 14, wherein said rigid material comprises a metal.

19. The device of claim 1, wherein a first cross-sectional dimension of the open distal end is smaller than a second cross-sectional dimension of the inner lumen.

20. The device of claim 1, wherein the pulses of discontinuous negative pressure have a cycling frequency of between about 1 Hz and about 100 Hz.

21. The device of claim 1, wherein movement of one of said plurality of pistons in a first direction within one of said plurality of cylinders creates a first pulse of negative pressure, and wherein movement of a second of said plurality of pistons of pistons in the first direction within a second of said plurality of cylinders creates a second pulse of negative pressure.

22. The device of claim 21, wherein movement of said one of said plurality of pistons in a second, opposite direction within said one of said plurality of cylinders creates a first pulse of positive pressure.

23. The device of claim 22, wherein said first pulse of positive pressure seals a one-way, non-rigid inlet valve and transmits an amount of the first pulse of positive pressure through the non-rigid inlet valve to the inner lumen of the elongate member.

24. The device of claim 23, wherein said first pulse of positive pressure results in an amount of fluid being expelled from the distal opening of the elongate member.

25. The device of claim 1, wherein the cam assembly is operatively coupled to at least one spring configured to be compressible by the cam mechanism, wherein a first amount of rotation of the cam assembly causes a compression of the spring and a second amount of rotation of the cam assembly causes a reduction in said compression of the spring.

26. The device of claim 25, wherein said reduction in said compression causes the distal cutting tip to move in a distal direction relative to the proximal, reusable portion.

27. The device of claim 1, wherein a first cross-sectional area of the open distal end is smaller than a second cross-sectional area of the inner lumen.

28. The device of claim 1, wherein the elongate member is repeatedly advanced and retracted along a non-linear pathway.

29. The device of claim 28, wherein the non-linear pathway is curvilinear.

30. The device of claim 28, wherein the non-linear pathway is elliptical.