Tissue removal devices, systems and methods

• US 9,561,129 B2
• Filed: 09/04/2012
• Issued: 02/07/2017
• Est. Priority Date: 01/07/2009
• Status: Active Grant

• Current Assignee: Liquet Technologies Incorporated
• Original Assignee: Medlogics, Inc.
• Inventors: Ross, Rodney L., Dennewill, James, Hughes, Gregg
• Primary Examiner(s): Kayman, Imani
• Application Number:
  US13/602,925
• Publication Number:
  US 20130060210A1
• Time in Patent Office: 1,617 Days
• US Class Current: 1/1
• 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 1/743 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
• 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 2205/3653 by Joule effect, i.e. electric resistance
• CPC Class Codes: A61M 2210/0612 Eyes

Abstract

A tissue removal device includes a rigid aspiration cannula, a valve communicating with the aspiration cannula in a fluid-sealed manner, and a pneumatically-driven actuator configured for moving the valve between an open position and a closed position, wherein at the open position the valve defines an aspiration path through the aspiration cannula and the valve, and at the closed position the valve prevents vacuum from being applied at the distal tip.

Claims

1. A tissue removal device, comprising:

a housing;

a rigid aspiration cannula extending from the housing to a distal tip outside the housing;

a valve disposed in the housing and configured for communicating with a vacuum source, the valve comprising a valve port communicating with the aspiration cannula in a fluid-sealed manner, wherein an inside diameter of the valve port is equal to or greater than an inside diameter of the distal tip; and

a pneumatically-driven actuator configured for moving the valve between an open position and a closed position, wherein;

at the open position, the valve port is open wherein the valve defines an aspiration path through the aspiration cannula and the valve;

at the closed position, the valve port is closed wherein the valve prevents vacuum from being applied at the distal tip;

the valve comprises an inner cannula and an outer cannula coaxially disposed about at least a portion of the inner cannula;

the inner cannula is configured for communicating with the vacuum source and is linearly movable by the actuator between the open position and the closed position;

the valve port is formed in the outer cannula;

at the open position the aspiration path passes through the outer cannula via the valve port and into the inner cannula; and

at the closed position the inner cannula blocks the valve port.

2. The tissue removal device of claim 1, comprising a transition adjoining the outer cannula at the valve port in a fluid-sealed manner, wherein the aspiration cannula extends along a first cannula axis from the transition to the distal tip, and the inner cannula extends along a second cannula axis offset from the first cannula axis.

3. The tissue removal device of claim 2, wherein the valve port is oriented at ninety degrees relative to the second cannula axis, and the transition turns at an angle of less than 90 degrees relative to the first cannula axis.

4. The tissue removal device of claim 1, 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.

5. The tissue removal device of claim 1, wherein the inside diameter of the valve port ranges from 0.05 mm to 5 mm, and the inside diameter of the distal tip ranges from 0.2 mm to 2 mm.

6. The tissue removal device of claim 1, comprising a gas conduit and a diaphragm, wherein the housing comprises a chamber wall, the diaphragm and the chamber wall cooperatively define a gas chamber with which the gas conduit communicates, the diaphragm is expandable in response to gas flowing from the gas conduit into the gas chamber, and the actuator is reciprocable in response to alternating expansion and contraction of the diaphragm.

7. The tissue removal device of claim 6, wherein the diaphragm comprises a diaphragm opening and the gas conduit passes through the diaphragm opening in a fluid-sealed manner.

8. The tissue removal device of claim 6, wherein the diaphragm comprises a first diaphragm opening and a second diaphragm opening, the gas conduit passes through the first diaphragm opening in a fluid-sealed manner, and the inner cannula passes through the second diaphragm opening and the gas chamber in a fluid-sealed manner.

9. The tissue removal device of claim 6, wherein the actuator comprises a piston mechanically communicating with the inner cannula and positioned to contact the diaphragm.

10. The tissue removal device of claim 9, wherein the piston mechanically communicates with the gas conduit, and the inner cannula and the gas conduit are linearly movable together with the piston.

11. The tissue removal device of claim 9, comprising a spring positioned to impart a biasing force against movement of the piston in a direction toward the open position, wherein the inner cannula is biased toward the closed position.

12. The tissue removal device of claim 9, wherein the piston comprises a piston head positioned to contact the diaphragm, and a sleeve surrounding the inner conduit.

13. The tissue removal device of claim 1, wherein the actuator is configured for communicating with a valve control device such that the inner cannula is reciprocable between the open position and the closed position to induce vacuum pulses in the aspiration cannula at a controllable pulse rate.

14. The tissue removal device of claim 1, comprising a cylindrical cannula seal composed of a resilient material, the cylindrical cannula seal circumscribing at least a portion of the aspiration cannula in fluid-sealing contact therewith, the cylindrical cannula seal comprising a distal seal end, a proximal seal end of greater inside diameter than the distal seal end, and a tapered section between the distal seal end and the proximal seal end.

15. 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 the valve is biased toward the closed position.

16. The tissue removal device of claim 1, comprising a gas conduit disposed in the housing and communicating with the actuator, the gas conduit configured for communicating with a pressurized gas source.

17. The tissue removal device of claim 16, comprising a diaphragm, wherein the housing comprises a chamber wall, the diaphragm and the chamber wall cooperatively define a gas chamber with which the gas conduit communicates, the diaphragm is expandable in response to gas flowing from the gas conduit into the gas chamber, and the valve is reciprocable in response to alternating expansion and contraction of the diaphragm.

18. The tissue removal device of claim 1, wherein the actuator comprises a piston communicating with the valve.

19. The tissue removal device of claim 18, 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 the valve and the gas conduit are movable together with the piston.

20. The tissue removal device of claim 1, wherein at least a portion of the aspiration cannula is tapered such that an inside diameter of the distal tip is smaller than an inside diameter of a proximal end of the aspiration cannula.

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

22. A tissue removal system, comprising:

a tissue removal device comprising;

a housing;

a rigid aspiration cannula extending from the housing to a distal tip outside the housing;

a valve disposed in the housing and configured for communicating with a vacuum source, the valve comprising a valve port communicating with the aspiration cannula in a fluid-sealed manner, wherein an inside diameter of the valve port is equal to or greater than an inside diameter of the distal tip; and

a pneumatically-driven actuator configured for moving the valve between an open position and a closed position, wherein;

at the open position, the valve port is open wherein the valve defines an aspiration path through the aspiration cannula and the valve; and

at the closed position, the valve port is closed wherein the valve prevents vacuum from being applied at the distal tip;

an aspiration line communicating with the valve and passing through the housing of the tissue removal device; and

a cassette comprising a cassette interior, an aspiration inlet communicating with the aspiration line and the cassette interior, 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,

wherein the aspiration path runs from the inner cannula, through the aspiration line and into the cassette interior.

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

the cassette comprises a fluid-routing chamber, a collection chamber communicating with the vacuum outlet, an interior structure fluidly isolating the fluid-routing chamber from the collection chamber, and a cassette inlet leading from outside the cassette into the fluid-routing chamber;

the interior structure comprises a transfer passage between the fluid-routing chamber and the collection chamber;

the aspiration inlet communicates with the transfer passage; and

the aspiration line passes through the cassette inlet and into communication with the aspiration inlet, wherein the aspiration path runs through the transfer passage and into the collection chamber.

24. The tissue removal system of claim 23, wherein the aspiration inlet is disposed in the fluid-routing chamber, and the cassette is configured such that the fluid-routing chamber and the aspiration inlet are inaccessible by a user, and such that the tissue removal device and the cassette comprise a permanently assembled single unit.

25. The tissue removal system of claim 23, comprising a gas conduit disposed in the housing of the tissue removal device and communicating with the actuator, the gas conduit configured for communicating with a pressurized gas source, wherein the cassette comprises a gas port leading from outside the cassette into the fluid-routing chamber, the gas conduit passes through the housing of the tissue removal device, through the cassette inlet and into communication with the gas port, and at the installed position the gas port communicates with the pressurized gas source.

26. The tissue removal system of claim 22, wherein the cassette comprises a hydrophobic filter disposed in the cassette interior and configured for preventing liquid in the cassette interior from passing through the vacuum outlet.

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

the cassette comprises a first collection chamber communicating with the aspiration inlet, 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.

28. The tissue removal system of claim 27, wherein the cassette comprises a fluid level indicator configured for indicating a level of fluid in the first collection chamber.

29. The tissue removal system of claim 28, wherein the fluid level indicator is configured for generating an output signal in response to fluid reaching a threshold level in the first collection chamber, and the console is configured for adjusting vacuum applied to the cassette based on the output signal.

30. The tissue removal system of claim 28, wherein the console is configured for adjusting by applying a vacuum to the second collection chamber sufficient to open the cassette valve, or ceasing application of vacuum to the cassette.

31. The tissue removal system of claim 27, 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.

32. The tissue removal system of claim 22, comprising the console, 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 the valve of the tissue removal device between the open position and the closed position to induce vacuum pulses in the aspiration cannula at a controllable pulse rate.

33. The tissue removal system of claim 32, comprising a gas conduit disposed in the housing of the tissue removal device and communicating with the actuator, wherein:

the cassette comprises a collection chamber communicating with the aspiration inlet and the vacuum outlet, a fluid-routing chamber fluidly isolated from the collection chamber, a cassette inlet leading from outside the cassette into the fluid-routing chamber, and a gas port leading from outside the cassette into the fluid-routing chamber;

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 the cassette inlet and into communication with the gas port, wherein at the installed position the gas conduit communicates with the valve control device.

34. The tissue removal system of claim 22, wherein the aspiration line is permanently installed in the housing of the tissue removal device and in the cassette, the tissue removal device is configured such that an interior thereof is inaccessible by a user, and the cassette is configured such that the cassette interior is inaccessible by the user, and such that the tissue removal device and the cassette comprise a permanently assembled single unit.