Tissue removal devices, systems and methods

• US 10,441,460 B2
• Filed: 04/18/2014
• Issued: 10/15/2019
• Est. Priority Date: 04/26/2013
• Status: Active Grant

• Current Assignee: Liquet Technologies Incorporated
• Original Assignee: Med-Logics Incorporated
• Inventors: Ross, Rodney L., Dennewill, James
• Primary Examiner(s): Mehta, Bhisma
• Assistant Examiner(s): Shah, Nilay J
• Application Number:
  US14/786,316
• Publication Number:
  US 20160058614A1
• Time in Patent Office: 2,006 Days
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00176 Two pulses, e.g. second pulse having an effect different from the first one
• CPC Class Codes: A61B 2217/005 with suction drainage system
• 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 9/00745 using mechanical vibrations, e.g. ultrasonic
• CPC Class Codes: A61M 1/743 by changing the cross-section of the line, e.g. flow regulating valves A61M1/7413 takes precedence
• CPC Class Codes: A61M 1/75 Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence

Abstract

A tissue removal device includes a hollow needle, an ultrasonic transducer for mechanically vibrating the needle, an aspiration line communicating with the needle, and a vacuum pulsing device for generating vacuum pulses in the needle. The device may be utilized for breaking up tissue by phacoemulsification, vacuum pulsing, or both.

Claims

1. A tissue removal device, comprising:

a housing;

a hollow needle extending from the housing and comprising an open distal tip outside the housing;

an ultrasonic transducer positioned in the housing and configured for mechanically vibrating the needle;

an aspiration line communicating with the needle and configured for communicating with a vacuum source outside the housing, wherein the needle and the aspiration line define an aspiration path from the distal tip, through the housing, and out from the housing to the vacuum source; and

a vacuum pulsing device positioned outside the housing and configured for operator control of vacuum pulses at an open end of the distal tip, the vacuum pulsing device comprising an actuator and a movable member, wherein the actuator is configured for moving the movable member alternately between a closed position that obstructs the aspiration path and an open position.

2. The tissue removal device of claim 1, wherein the housing comprises a first coupling member, and the vacuum pulsing device comprises a second coupling member configured for coupling to the first coupling member such that the aspiration path passes into the vacuum pulsing device via the first coupling member and the second coupling member.

3. The tissue removal device of claim 1, wherein the actuator is pneumatically driven, mechanically driven, electrically driven, electromechanically driven, magnetically driven, or electromagnetically driven, and

at least one of a vacuum pulse duration, a vacuum level, and a vacuum pulse frequency is set by the operator control.

4. The tissue removal device of claim 1, wherein the movable member is configured for pinching the aspiration line at the closed position.

5. The tissue removal device of claim 1, wherein the vacuum pulsing device comprises a valve port through which the aspiration path passes, at the open position the valve port is open such that a vacuum applied at the distal tip, and at the closed position the valve port is closed such that the vacuum is prevent from being applied at the distal tip, and the valve port is configured to be adjustable between either totally closed or partially closed.

6. The tissue removal device of claim 5, wherein the movable member comprises an inner cannula, the vacuum pulsing device comprises an outer cannula coaxially disposed about at least a portion of the inner cannula, the valve port is formed in the outer cannula, at the open position the aspiration path passes from the valve port into the inner cannula, at the closed position the inner cannula blocks the valve port.

7. The tissue removal device of claim 6, wherein the vacuum pulsing device comprises an aspiration inlet communicating with the aspiration line in the housing, and a transition communicating with the aspiration inlet and adjoining the outer cannula at the valve port in a fluid-sealed manner, wherein the aspiration inlet extends along a first axis to the transition and the inner cannula extends along a second axis offset from the first axis.

8. The tissue removal device of claim 7, wherein the valve port is oriented at ninety degrees relative to the second axis, and the transition turns at an angle of less than 90 degrees relative to the first axis.

9. The tissue removal device of claim 6, wherein the outer cannula comprises a distal outer cannula end and a resilient seal closing the distal outer cannula end in a fluid-sealed manner, and at the closed position the inner cannula contacts the resilient seal in a fluid-sealed manner.

10. The tissue removal device of claim 5, wherein a valve port inside diameter is greater than a distal tip inside diameter.

11. The tissue removal device of claim 1, comprising a spring positioned to impart a biasing force against movement of the actuator in a direction toward the open position, wherein a valve of the vacuum pulsing device is biased toward the closed position.

12. The tissue removal device of claim 1, wherein the vacuum pulsing device comprises a gas conduit configured for communicating with a pressurized gas source, a diaphragm, and a chamber wall, the diaphragm and the chamber wall cooperatively defining a gas chamber with which the gas conduit communicates, and wherein the diaphragm is expandable in response to gas flowing from the gas conduit into the gas chamber, and the movable member is movable between the open position and the closed position in response to alternating expansion and contraction of the diaphragm.

13. The tissue removal device of claim 1, wherein the actuator comprises a piston communicating with the movable member.

14. The tissue removal device of claim 13, comprising a gas conduit disposed in the housing and communicating with the piston, the gas conduit configured for communicating with a pressurized gas source, wherein a valve of the vacuum pulsing device and the gas conduit are movable together with the piston.

15. The tissue removal device of claim 1, wherein the actuator is configured for communicating with a valve control device such that the movable member is movable between the open position and the closed position to induce the vacuum pulses in an aspiration cannula of the vacuum pulsing device according to a controllable pulse parameter.

16. The tissue removal device of claim 1, wherein the ultrasonic transducer and the vacuum pulsing device are configured for communicating with a control console, and the control console is configured for switching the tissue removal device among a plurality of operating modes, the plurality of operating modes comprising a phacoemulsification-only mode in which the ultrasonic transducer is active while the vacuum pulsing device is inactive, a vacuum pulsing-only mode in which the ultrasonic transducer is inactive while the vacuum pulsing device is active, and a phacoemulsification-vacuum pulsing mode in which the ultrasonic transducer and the vacuum pulsing device are active sequentially or simultaneously.

17. A tissue removal system, comprising:

the tissue removal device of claim 1;

a tissue collection receptacle; and

an external aspiration line running from the vacuum pulsing device to the tissue collection receptacle,

wherein the aspiration path runs from the needle, through the housing, through the vacuum pulsing device, through the external aspiration line, and into the tissue collection receptacle.

18. The tissue removal system of claim 17, comprising a control console, the control console comprising a controller configured for controlling the ultrasonic transducer and the vacuum pulsing device.

19. The tissue removal system of claim 18, wherein the controller is configured for switching the system to a plurality of operating modes, the plurality of operating modes comprising a phacoemulsification-only mode in which the ultrasonic transducer is active while the vacuum pulsing device is inactive, a vacuum pulsing-only mode in which the ultrasonic transducer is inactive while the vacuum pulsing device is active, and a phacoemulsification-vacuum pulsing mode in which the ultrasonic transducer and the vacuum pulsing device are active sequentially or simultaneously.

20. The tissue removal system of claim 18, wherein the control console comprises a component selected from the group consisting of:

a power source communicating with the ultrasonic transducer;

a valve control device communicating with the actuator of the vacuum pulsing device;

a pressurized gas source communicating with the actuator of the vacuum pulsing device;

a vacuum source communicating with the vacuum pulsing device;

a receptacle for receiving the tissue collection receptacle; and

a combination of two or more of the foregoing.

21. The tissue removal system of claim 17, wherein the tissue collection receptacle comprises a cassette, and the cassette comprises a cassette interior communicating with the external aspiration line, and a vacuum outlet communicating with the cassette interior and configured for communication with the vacuum source, wherein the cassette is configured for being operated in an installed position at which the cassette is removably inserted into a console, and at the installed position the vacuum outlet communicates with the vacuum source.

22. The tissue removal system of claim 21, wherein:

the cassette comprises a first collection chamber communicating with the external aspiration line, a second collection chamber of larger volume than the first collection chamber, an interior structure separating the first collection chamber from the second collection chamber and comprising a bore leading from the first collection chamber to the second collection chamber;

the cassette comprises a cassette valve alternately opening and closing the bore and configured to be closed when pressure in the first collection chamber is lower than pressure in the second collection chamber; and

the vacuum outlet comprises a first vacuum port communicating with the first collection chamber and a second vacuum port communicating with the second collection chamber.

23. The tissue removal system of claim 22, wherein the console is configured for adjusting a vacuum applied to the cassette by applying the vacuum to the second collection chamber sufficient to open the cassette valve, or ceasing application of the vacuum to the cassette.

24. The tissue removal system of claim 22, comprising a vacuum regulator communicating with the vacuum source and configured for controlling vacuum levels respectively applied to the first vacuum port and the second vacuum port.

25. The tissue removal system of claim 21, wherein the vacuum source is located in the console, and the console comprises:

a receptacle for removably receiving the cassette at the installed position;

a vacuum coupling configured for detachably coupling with the vacuum outlet at the installed position; and

a valve control device configured for communicating with the actuator at the installed position to control movement of a valve of the tissue removal device between the open position and the closed position to induce the vacuum pulses in the aspiration cannula at a controllable pulse rate.

26. The tissue removal system of claim 25, comprising a gas conduit communicating with the actuator, wherein:

the cassette comprises a collection chamber communicating with the external aspiration line and the vacuum outlet, and a gas port leading from outside the cassette into the cassette;

the console comprises a pressurized gas source communicating with the valve control device, and a gas coupling configured for detachably coupling with the gas port at the installed position; and

the gas conduit passes through the housing of the tissue removal device, through a cassette inlet and into communication with the gas port, wherein at the installed position the gas conduit communicates with the valve control device.

27. The tissue removal system of claim 17, comprising a controller configured for providing a pulsed vacuum as a series of the vacuum pulses having a vacuum on period followed by a vacuum off period to form a pulse period, the vacuum pulses being generated at a frequency determined by the pulse period.

28. The tissue removal system of claim 17, comprising a controller configured for providing a pulsed vacuum as a series of the vacuum pulses having a vacuum on period followed by a vacuum off period to form a pulse period, the vacuum pulses being generated with a duty cycle determined by adjusting the vacuum on period for a given pulse period.

29. The tissue removal system of claim 17, comprising a controller configured for controlling the extent to which a valve port through which the aspiration path passes is open, and providing a pulsed vacuum as a series of the vacuum pulses defined by a maximum vacuum level and a minimum vacuum level, wherein the maximum vacuum level and the minimum vacuum level correspond to the extent to which the valve port is opened, the maximum vacuum level corresponds to the valve port being up to 100% open, and the minimum vacuum level corresponds to the valve port being 0% open or greater.

30. The tissue removal device of claim 17, comprising a control console configured for receiving user input to determine a flow rate in the aspiration path, and controlling the flow rate based on the user input by controlling a base vacuum provided by the vacuum source.

31. A method for removing tissue from a surgical site, the method comprising:

inserting the distal tip of the needle of the tissue removal device of claim 1 into the surgical site, wherein the ultrasonic transducer of the tissue removal device is coupled to the needle, and the needle is in fluid communication with the vacuum pulsing device;

breaking up the tissue in the surgical site by operating the tissue removal device according to a mode selected from the group consisting of;

a phacoemulsification-only mode in which the ultrasonic transducer vibrates the needle while the vacuum pulsing device is inactive;

a vacuum pulsing-only mode in which the ultrasonic transducer is inactive while the vacuum pulsing device applies the vacuum pulses to the tissue via the distal tip; and

a phacoemulsification-vacuum pulsing mode in which the ultrasonic transducer vibrates the needle and the vacuum pulsing device is active, sequentially or simultaneously with vibrating the needle, to apply the vacuum pulses to the tissue via the distal tip; and

aspirating the broken up tissue through the needle, through the vacuum pulsing device, and to a tissue collection site.