Cataract surgery devices and methods for using same

• US 7,172,601 B2
• Filed: 05/20/2001
• Issued: 02/06/2007
• Est. Priority Date: 05/22/2000
• Status: Expired due to Fees

• Current Assignee: Itos International Ltd.
• Original Assignee: Itos International Ltd.
• Inventors: Ben-Nun, Joshua
• Primary Examiner(s): McDermott; Corrine
• Assistant Examiner(s): Prone; Christopher D.
• Application Number:
  US10/296,005
• Publication Number:
  US 20030158567A1
• Time in Patent Office: 2,088 Days
• Field of Search: 606 20- 31, 606/166, 606/170, 606/172, 606/107, 607/104, 607/141, 607 96- 99, 607/113, 604/22, 604/521, 408/57, 408/59, 175/321, 166/244.1
• US Class Current: 606/107
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2017/00977 the depression depth determining the power rate
• CPC Class Codes: A61B 2018/00041 Heating, e.g. defrosting
• CPC Class Codes: A61B 2018/0262 using a circulating cryogenic fluid
• CPC Class Codes: A61B 2090/036 abutting on tissue or skin
• CPC Class Codes: A61B 2090/0817 Spatulas or spatula like extensions
• 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

A surgical apparatus having a surgical tip, comprising: cooling means for freeze-sealing mammalian tissue, and control means, which control and induce coolant flow from coolant supply means, through a coolant outflow tube into an expansion chamber at the surgical tip. The temperature at the tip is thus lowered to a temperature at which mammalian tissue contacting the expansion chamber would adhere to the apparatus. The apparatus additionally comprises electrically powered heating means acting to raise and regulate the temperature of the apparatus; control means for activating the heating means, and power supply means. The apparatus is especially useful for surgery of tissue within a capsule, such as cataract surgery. In a preferred embodiment, the apparatus additionally comprises: a drill member coupled with a motor, an irrigation tube and an aspiration tube.

Claims

1. A surgical apparatus comprising:

a housing, said apparatus having a proximal end and a surgical tip at its distal end, said housing containing therewithin;

cooling means for freeze-sealing mammalian tissue, said cooling means extending from said housing to the surgical tip, said cooling means comprising;

a) a coolant outflow tube having a lumen in communication with coolant supply means, said coolant outflow tube providing flow of coolant through said lumen from said proximal end towards said surgical distal end of said apparatus;

b) a coolant return tube providing return of coolant from said surgical distal end towards said proximal end of the apparatus;

at least one communicating bore present in the distal end of the apparatus allows passage of coolant from the coolant outflow tube to the coolant return tube;

an expansion chamber having a cross-section larger than that of the coolant return tube, said expansion chamber located on the extreme distal end of said coolant return tube,

said coolant outflow tube being concentrically disposed within said coolant return tube;

electrically-powered heating means, said heating means raising and regulating the temperature of said apparatus; and

a thermostat for determining the temperature of the surgical tip;

wherein said coolant outflow tube further allows introduction of tissue-emulsifying surgical implements so as to extend out through said surgical distal end of said apparatus;

and said apparatus being electrically connected to;

a control unit activating said cooling means, and said control unit activating said heating means, such that upon activation of said control unit, coolant flow is induced from said coolant supply means, through said coolant outflow tube towards the distal end of said coolant outflow tube, through said communicating bore into said expansion chamber resulting in lowering the temperature at the expansion chamber to a temperature at which mammalian tissue contacting the expansion chamber would adhere to the apparatus.

2. The apparatus of claim 1, additionally comprising a drill member coupled with a motor, said drill member including a shaft having a distal end and a drill bit at said distal end, said drill member protruding from the center of the surgical tip of said apparatus.

3. The apparatus of claim 2, wherein said drill member is rotatable to a speed of approximately 80,000 RPM.

4. The apparatus of claim 2, wherein said drill member comprises a drill bit having balanced blades with oppositely tapered ends, said blades connected to a crossbar.

5. The apparatus of claim 2, wherein said drill bit and drill shaft are formed of a metal selected from titanium and stainless steel.

6. The apparatus of claim 1, wherein said electrically powered heating means comprise a heat-conductive element included in an electrical circuit, at least a portion of said element located at said surgical tip;

wherein activation of electrical current to said circuit results in generation of heat from said element.

7. The apparatus of claim 1, additionally comprising a carrier tube present within the lumen of said coolant outflow tube, and additionally comprising an irrigation fluid source, said carrier tube configured for transport of irrigation fluid to said surgical tip from said irrigation fluid source.

8. The apparatus of claim 7, further comprising a plurality of valves for regulating the flow of irrigation fluid in said apparatus.

9. The apparatus of claim 1, wherein said surgical tip is disposable.

10. The apparatus of claim 1, wherein said coolant outflow tube and said coolant return tube are closed at said respective distal ends, closing said passageway.

11. The apparatus of claim 10, wherein said closed distal ends of said coolant outflow tube and said coolant return tube define a shoulder, extending outward from said apparatus.

12. The apparatus of claim 11, wherein said distal end of said surgical tip extends a distance beyond said shoulder, said distance corresponding to a maximum surgical penetration depth into the human body, for the surgical tip of said apparatus.

13. The apparatus of claim 1, wherein said apparatus further comprises a suction tube present within the lumen of said coolant outflow tube, for providing suction of fluids from said surgical tip;

said suction tube being in communication with a suction unit.

14. The apparatus of claim 1, wherein said coolant supply means provides a coolant selected from:

compressed carbon dioxide and compressed nitrous oxide.

15. The apparatus of claim 1, further comprising a plurality of valves for regulating the flow of coolant in said apparatus.

16. The apparatus of claim 1, further comprising a coolant outflow line, from which coolant is discharged to the ambient environment after passage through the expansion chamber.

17. The apparatus of claim 1, wherein the surgical tip is formed from a head portion and a core.

18. The apparatus of claim 17, wherein said core is separated from the head portion by an electrically insulating ring and an air gap, such that the head portion and the core can maintain opposing electrical potentials to form an electrical circuit and said head portion and said core are each connected to an opposing terminal on an electrical power supply;

wherein said circuit is electrically connected to said heating means.

19. The apparatus of claim 17, wherein said head portion is formed of two members, separated by an O-ring therebetween.

20. The apparatus of claim 19, wherein said O-ring is formed of a polymer, for providing shock absorbance from vibrations.

21. The apparatus of claim 17, wherein said head portion is formed of surgical grade steel, or from plastic having electrically conducting wires therein.

22. The apparatus of claim 1, wherein the temperature at the expansion chamber can reach approximately −

5°

C. to −

10°

C. upon flow of coolant flow into said expansion chamber.

23. The apparatus of claim 1, wherein said heating means heat to a temperature of approximately 25°

C. to 35°

C.

24. A method of use of the apparatus of claim 1 for surgery of tissue within a capsule comprising:

a) creating a minimal size opening in said capsule using a surgical knife followed by activation of a thermal electrical pulsed burning tool;

b) providing the apparatus of claim 1,

c) inserting at least a portion of a drill bit or at least a portion of a phacoemulsification transducer through said opening into said capsule;

d) contacting the opening in said capsule with the expansion chamber of said apparatus;

e) cooling said expansion chanter such that sufficient cooling transfers to said capsule allowing for freeze-sealing the opening of said capsule by said apparatus around said drill bit or around said transducer;

f) activating said heating means, to limit conduction of said cooling toward at least said proximal handle end of said apparatus;

g) irrigating said capsule with irrigation fluid to hydrodissect said capsule;

h) rotating said drill bit or activating said transducer so as to emulsify at least a portion of said tissue in said capsule;

further irrigating said capsule and providing suction to flush away said emulsified tissue;

i) deactivating said cooling means to allow the temperature of said expansion chamber to rise and said freeze-seal to break;

j) retracting the apparatus from the capsule.

25. The method of claim 24, wherein the encapsulated tissue in said capsule includes a cataract and said capsule is a lens capsule.

26. The method of claim 25, wherein said creating an opening in said capsule includes creating an opening in said lens capsule proximate to said cataract, and wherein said opening has a maximal length or diameter of 1–

3.5 mm in the cornea, and a maximal length or diameter of 2 mm in the lens.

27. The method of claim 24 wherein said contacting the capsule includes positioning said expansion chamber to surround at least a substantial portion of said opening.

28. The method of claim 27, wherein said positioning includes surrounding all of said opening and the periphery surrounding the opening.

29. The method of claim 24, wherein in said step of cooling and freeze-sealing, the temperature at the expansion chamber is lowered to approximately −

5°

C. to −

10°

C. upon flow of coolant flow into said expansion chamber.

30. The method of claim 24, wherein in said step of activating said heating means, the temperature of said heating means is raised to approximately 25°

C. to 35°

C.

31. The method of claim 24, wherein said freeze-sealing of said capsule maintains the integrity of the capsule opening, preventing shearing forces from damaging the capsule and preventing leakage of bodily material from within the capsule.

32. The method of claim 24, additionally comprising pressurizing said surgical site.

33. The method of claim 24, wherein the capsule comprises one of the following pathologies:

an encapsulated tumor, a meniscus and an encapsulated parasite.