TISSUE REMOVAL DEVICES, SYSTEMS AND METHODS

• US 20100191178A1
• Filed: 01/07/2010
• Published: 07/29/2010
• Est. Priority Date: 01/07/2009
• Status: Active Grant

• Current Assignee: Liquet Technologies Incorporated
• Original Assignee: Enlighten Technologies, Inc.
• Inventors: Ross, Rodney L., Hughes, Gregg
• Granted Patent: US 9,370,611 B2
• Time in Patent Office: Days
• US Class Current: 604/22
• CPC Class Codes: A61B 18/082 Probes or electrodes therefor
• 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: A61M 1/7415 by deformation of the fluid passage
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• CPC Class Codes: A61M 1/84 Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2039/2473 Valve comprising a non-deformable, movable element, e.g. ball-valve, valve with movable stopper or reciprocating element
• CPC Class Codes: A61M 2039/2486 Guided stem, e.g. reciprocating stopper
• CPC Class Codes: A61M 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2210/0612 Eyes

Abstract

A tissue removal device includes a cannula that can aspirate tissue, and a thermal element located at a tip of the cannula that can apply localized heat to the tissue to be aspirated. The tissue removal device may also include a device for applying a vacuum in the cannula, which may be configured for applying vacuum pulses according to a controlled pulse rate and vacuum level. The tissue removal device may also include a device for applying the heat at the tip according to a controllable pulse rate and power level.

Claims

1. A tissue removal device, comprising:

a cannula that for aspirating tissue; and

a thermal element located at a tip of the cannula for applying localized heat at the tip to the tissue to be aspirated.

2. The tissue removal device of claim 1, further comprising a device for applying a vacuum in the cannula.

3. The tissue removal device of claim 2, wherein the device for applying the vacuum is configured to apply vacuum pulses according to a controllable pulse rate and vacuum level.

4. The tissue removal device of claim 1, further comprising a device for applying the heat at the tip according to a controllable pulse rate and power level.

5. A method for removing tissue, comprising:

applying localized heat to the tissue from a tip of a cannula; and

aspirating the heated tissue through the cannula.

6. The method of claim 5, wherein the heat is applied in pulses.

7. The method of claim 5, wherein the tissue is aspirated by applying vacuum pulses.

8. A tissue denaturing device, comprising:

a cannula including an open distal end and an inner passage terminating at the distal end, the inner passage configured to fluidly communicate with a vacuum source; and

a heat-generating distal element including an annular tip portion constructed from a thermally and electrically conductive material, and a first electrical contact area and a second electrical contact area configured to electrically communicate with an electrical energy source for running electrical current through the annular tip portion, the annular tip portion disposed at the distal end and fluidly communicating with the inner passage,

wherein the tissue denaturing device establishes a tissue aspiration path from an environment outside the tissue denaturing device and through the annular tip portion and the inner passage.

9. A method for denaturing tissue, comprising:

moving a distal section of a tissue denaturing device toward a target tissue to be removed from surrounding tissue, the distal section including a cannula and a heat-generating distal element, the cannula including an open distal end and an inner passage terminating at the distal end, the distal element including an annular tip portion disposed at the distal end and defining a tip opening fluidly communicating with the inner passage;

causing the target tissue to move into and occlude the tip opening by generating a vacuum in the inner passage;

causing the distal element to generate heat to transfer heat to the target tissue; and

utilizing the vacuum generated in the inner passage to aspirate the heated tissue through the tip opening and the inner passage.

10. A tissue removal device, comprising:

a handpiece enclosing a handpiece interior and having a proximal handpiece opening and a distal handpiece opening;

a vacuum conduit extending from the proximal handpiece opening and through the handpiece interior and the distal handpiece opening, and terminating at an open distal conduit end disposed outside the handpiece at a distance from the distal handpiece opening; and

a valve mechanism communicating with the vacuum conduit and configured to control vacuum pressure in the vacuum conduit,

wherein the vacuum conduit includes a rigid conduit section extending from the valve mechanism to the distal conduit end.

11. The tissue removal device of claim 10, further including a vacuum control device electrically communicating with the valve mechanism and including pulse rate control circuitry configured to actuate the valve mechanism between an open state and a closed state to induce vacuum pulses in the vacuum conduit at a controllable pulse rate.

12. The tissue removal device of claim 11, wherein the pulse rate control circuitry includes a pulse rate controller disposed remotely from the handpiece and selected from the group consisting of a user-operated console input and a user-operated foot switch.

13. The tissue removal device of claim 11, wherein the vacuum control device further includes vacuum-mode switching circuitry configured to switch the valve mechanism between a continuous-vacuum mode and a pulsed vacuum mode.

14. The tissue removal device of claim 13, wherein the vacuum-mode switching circuitry includes a switch disposed remotely from the handpiece and selected from the group consisting of a user-operated console switch and a user-operated foot switch.

15. The tissue removal device of claim 11, wherein the vacuum control device further includes vacuum-mode switching circuitry configured to switch the valve mechanism between a single-pulse vacuum mode and a pulse-train vacuum mode.

16. The tissue removal device of claim 15, wherein the vacuum-mode switching circuitry includes a switch disposed remotely from the handpiece and selected from the group consisting of a user-operated console switch and a user-operated foot switch.

17. The tissue removal device of claim 10, wherein at least a portion of the valve mechanism is enclosed in the handpiece.

18. The tissue removal device of claim 10, further including a vacuum transducer configured to measure a vacuum level in the vacuum conduit and vacuum control circuitry communicating with the vacuum transducer, vacuum control circuitry being configured to switch the valve mechanism between a plurality of different vacuum control modes in response to a vacuum-level measurement signal received from the vacuum transducer.

19. The tissue removal device of claim 10, further including a vacuum control device communicating with the valve mechanism and configured to control a level of vacuum in the vacuum conduit and a rate of vacuum pulsing in the vacuum conduit, and configured to be switched between a first control mode in which vacuum level and pulse rate are adjusted together and a second control mode in which vacuum level and pulse rate are adjusted independently.

20. A method for removing tissue from an eye, the method comprising:

inserting a distal tip of a vacuum conduit of a tissue removal device through an incision formed in the eye and into an interior of the eye;

breaking up tissue in the interior by applying a series of vacuum pulses to the tissue via the vacuum conduit, wherein applying the vacuum pulses includes actuating a valve mechanism communicating with a rigid section of the vacuum conduit alternately between an open state and a closed state, the rigid section extending from the valve mechanism to the distal tip; and

aspirating the broken-up tissue through the vacuum conduit to a receiving site disposed remotely from the tissue removal device.

21. The method of claim 20 further including, prior to breaking up tissue, placing the distal tip against a structure of the eye while applying a continuous vacuum pressure in the vacuum conduit, switching from applying the continuous vacuum pressure to applying a single vacuum pulse to the structure to form an incision through the structure, and inserting the distal tip through the structure.

22. The method of claim 20, further including adjusting a pulse rate of the vacuum pulses by operating a control communicating with the valve mechanism and disposed remotely therefrom, wherein the control is selected from the group consisting of a user-operated console input and a user-operated foot switch.

23. The method of claim 20, further including switching operation of the tissue removal device between a pulsed-vacuum mode and a continuous-vacuum mode by operating a control communicating with the valve mechanism and disposed remotely therefrom, wherein the control is selected from selected from the group consisting of a user-operated console input and a user-operated foot switch.

24. The method of claim 20, further including controlling a rate of flow of broken-up tissue through the vacuum conduit by adjusting a frequency of the vacuum pulses.

25. A tissue removal device, comprising:

a handpiece having a distal handpiece opening;

a vacuum conduit disposed in the handpiece;

a cannula extending from the vacuum conduit and terminating at an open distal tip disposed outside the handpiece at a distance from the distal handpiece opening, the cannula including a first cannula wall, a second cannula wall opposite to the first cannula wall, a first seal interposed between the first cannula wall and the second cannula wall, and a second seal interposed between the first cannula wall and the second cannula wall in opposition to the first seal, wherein the first cannula wall and the second cannula wall are constructed from an electrically conductive material, the first seal and the second seal are constructed from an electrically insulative material, and the cannula is attached to the vacuum conduit so as to establish a vacuum-tight fluid path from the distal tip to the vacuum conduit; and

a resistive heating element attached to the first cannula wall and the second cannula wall so as to establish an electrical conduction path from the first cannula wall, through the heating element and to the second cannula wall.

26. The tissue removal device of claim 25, wherein the distal tip of the cannula is coaxially disposed about a longitudinal axis, the resistive heating element includes a loop section coaxially disposed about the longitudinal axis and at least partially circumscribing the longitudinal axis, and the fluid path passes through the loop section and the distal tip to the vacuum conduit.

27. The tissue removal device of claim 26, wherein the loop section terminates at a sharp edge.

28. The tissue removal device of claim 25, wherein the cannula includes a tapered section terminating at the distal tip, and the distal tip has an inside cross-sectional area less than an inside cross-sectional area of a portion of the cannula adjacent to the tapered section.

29. The tissue removal device of claim 25, further including a plunger movable through the cannula and a flexible sealing element attached to a distal plunger end of the plunger.

30. The tissue removal device of claim 25, wherein the resistive heating element is coated with a non-stick material.

31. The tissue removal device of claim 25, further including a current control device electrically communicating with the resistive heating element via the cannula and switchable between a first setting at which current runs through the resistive heating element in a continuous manner and a second setting at which current runs through the resistive heating element in a pulsed manner.

32. The tissue removal device of claim 31, wherein the current control device includes a user-operated switching device configured to switch the current control device between the first setting and the second setting, and the user-operated switching device is selected from the group consisting of a console input and a foot switch.

33. The tissue removal device of claim 25, further including a valve mechanism communicating with the vacuum conduit and configured to control vacuum pressure in the vacuum conduit.

34. The tissue removal device of claim 33, further including a control device communicating with the resistive heating element and the valve mechanism and configured to control current level through the resistive heating element and vacuum pulsing in the vacuum conduit, and configured to be switched between a first control mode in which current level and vacuum pulsing are adjusted together and a second control mode in which current level and vacuum pulsing are adjusted independently.

35. A method for removing tissue from an eye, the method comprising:

inserting a hollow distal tip of a tissue removal device through an incision formed in the eye and into an interior of the eye;

transmitting heat energy to tissue in the eye interior proximate to the distal tip to break up the tissue, by running electrical current through an interior of the handpiece, through a conductive first cannula wall to a resistive heating element located at the distal tip, through the resistive heating element to a conductive second cannula wall, and from the second cannula wall back through the handpiece interior, wherein the first cannula wall and the second cannula wall form a cannula extending from the handpiece and terminating at the distal tip, and wherein most of the heat energy generated by running the electrical current is generated at the resistive heating element; and

aspirating the broken-up tissue through the cannula, through a vacuum conduit connected to the cannula and disposed in the handpiece, and to a receiving site disposed remotely from the handpiece, by applying vacuum at the distal tip.

36. The method of claim 35, wherein applying vacuum includes applying vacuum pulses.

37. A method for removing tissue from an eye, the method comprising:

inserting a distal tip of a vacuum conduit of a tissue removal device through an incision formed in the eye and into an interior of the eye;

breaking up tissue in the interior by applying a series of vacuum pulses to the tissue via the vacuum conduit, wherein applying the vacuum pulses includes actuating a valve mechanism communicating with a rigid section of the vacuum conduit alternately between an open state and a closed state, the rigid section extending from the valve mechanism to the distal tip; and

aspirating the broken-up tissue through the vacuum conduit to a receiving site disposed remotely from the tissue removal device.

38. The method of claim 37, wherein the vacuum conduit includes a cannula terminating at the distal tip, and breaking up tissue further includes transmitting heat energy to the tissue in the eye interior by running electrical current through an interior of the handpiece, through a conductive first cannula wall of the cannula to a resistive heating element located at the distal tip, through the resistive heating element to a conductive second cannula wall of the cannula, and from the second cannula wall back through the handpiece interior, wherein most of the heat energy dissipated by running the electrical current is dissipated from the resistive heating element.

39. A method for performing eye surgery, the method comprising:

inserting a distal tip of a cannula of a handheld surgical device through an incision formed in the eye and into an anterior capsule of the eye;

breaking up cataract material in the anterior capsule by applying a series of vacuum pulses to the cataract material via the cannula, wherein applying the vacuum pulses includes actuating a valve mechanism communicating with a vacuum conduit alternately between an open state and a closed state, while the vacuum conduit fluidly communicates with the cannula;

aspirating the broken-up tissue through the cannula and the vacuum conduit to a receiving site disposed remotely from the handheld surgical device;

moving a selector of the handheld surgical device from a first position at which the cannula communicates with the vacuum conduit to a second position at which the cannula fluidly communicates with a material injection bore; and

injecting a material into the anterior capsule via the injection bore and the cannula.

40. The method of claim 39, wherein injected material is selected from the group consisting of a material effective for denaturing cataract material and a refractive material utilized for lens prosthesis.

41. The method of claim 39, further comprising sealing the incision by inserting an incision seal through the incision, wherein an expandable portion of the incision seal expands on an inner side of the anterior capsule.

42. A handheld surgical instrument, comprising:

a housing including a distal end and a proximal end;

a cannula extending from the distal end; and

a rotatable hub disposed at the proximal end and including a plurality of user-selectable ports, wherein the rotatable hub is rotatable to a plurality of hub positions, and at each hub position one of the ports is in fluid communication with the cannula.

43. An incision seal, comprising:

a shaft including a distal end, and a proximal end configured for removable attachment to a surgical instrument; and

an expandable portion attached to the distal end and including a plurality of segments extending in radial directions from the distal end, wherein the expandable portion is movable from a retracted position at which the segments are oriented at a first angle relative to the shaft to an expanded position at which the segments are disposed at a second angle relative to the shaft greater than the first angle.