Biopsy instrument having irrigation and aspiration capabilities

• US 6,331,165 B1
• Filed: 05/15/1998
• Issued: 12/18/2001
• Est. Priority Date: 11/25/1996
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Kortenbach, Juergen, Francese, Jose L., Turturro, Vincent, Gottlieb, Saul
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/079,168
• Time in Patent Office: 1,313 Days
• Field of Search: 600/565, 600/562, 600/581, 606/205, 606/206, 606/207, 606/110, 606/121, 606/122, 606/123, 606/124
• US Class Current: 600/562
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/06 Biopsy forceps , e.g. with cup-shaped jaws
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2017/2939 Details of linkages or pivot points
• CPC Class Codes: A61B 2017/294 Connection of actuating rod to jaw, e.g. releasable
• CPC Class Codes: A61B 2090/035 preventing further rotation
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: G01N 1/31 Apparatus therefor

Abstract

A biopsy instrument and method of using such are provided wherein the biopsy instrument includes a proximal actuation handle, an elongate flexible member, and a distal assembly. The flexible member, connected to and extending from the actuation handle, includes an aspiration conduit for fluid connection with a vacuum source and for permitting the flow of fluid from the distal end to the proximal end of the biopsy instrument. The flexible member may include an irrigation conduit for supplying irrigation fluid to the distal end. The actuation handle includes a stationary member and an actuation device, and may include a sample chamber, a sample collector, valves for regulating the vacuum in the aspiration conduit and the fluid flow in the irrigation conduit, and a pressure increasing device for selectively increasing the pressure of the fluid supplied to the distal end. The distal assembly, coupled to the distal end of the flexible member, may be comprised of a movable jaw and a stationary jaw, or of first and second movable jaws. With the jaws in a closed position, the distal assembly may provide a substantially fluidtight passageway at the distal end of the aspiration conduit. The movable jaws are coupled to the actuation device, such that actuation of the actuation handle moves the movable jaws relative to the flexible member, thereby opening and closing the distal assembly.

Claims

1. A sample collector for use with a biopsy instrument having a suction passageway at least partially defined by a wall extending laterally to the suction passageway and an access opening located in the wall, the sample collector comprising:

a catcher handle having a securing end; and

a catcher body having a screen, the catcher body configured for insertion into the access opening, the catcher body being attached to the securing end of the catcher handle, and being positionable within the suction passageway upon insertion into the access opening.

2. The sample collector of claim 1 further including a cover positionable between an open position displaced from the screen and a closed position overlaying the screen.

3. The sample collector of claim 1 wherein the securing end is configured for insertion into the access opening and configured for complementing the access opening to provide a seal therewith.

4. The sample collector of claim 1 wherein the catcher body is removably attached to the catcher handle.

5. The sample collector of claim 2 wherein the catcher handle, the catcher body, the cover and a cover hinge are integrally molded.

20. The sample collector of claim 2 wherein the cover is slidably attached to one of the catcher body or catcher handle.

21. The sample collector of claim 2 wherein the cover is rotatably attached to one of the catcher body or catcher handle.

22. The sample collector of claim 2 wherein the catcher body with the cover in a closed position overlaying the screen fits a pathology processing cartridge.

23. The sample collector of claim 1 wherein the screen includes a plurality of perforations.

25. The sample collector of claim 1 wherein a portion of the catcher body complements the access opening to provide a seal therewith.

26. The sample collector of claim 5 wherein deformation of the material of the cover hinge permits the cover to rotate from an open position to a closed position.

27. The sample collector of claim 5 wherein at least one flexible ring encircles one of the catcher handle or catcher body for providing a seal with the access opening.

6. A biopsy instrument having a distal end and a proximal end, the biopsy instrument comprising:

a distal assembly for use in a surgical operation;

an elongate flexible member connected to and extending from the distal assembly to the proximal end, the flexible member having an aspiration conduit for fluid connection with a vacuum source and for permitting the passage of matter from the distal end to the proximal end;

a proximal actuation handle with a suction passageway having an access opening, the suction passageway in fluid connection with the aspiration conduit and for fluid connection with a vacuum source; and

a sample collector including a catcher handle with a securing end, and a catcher body with a screen, the catcher body for insertion into the access opening, being attached to the securing end of the catcher handle, and being positionable within the suction passageway upon insertion into the access opening.

7. The biopsy instrument of claim 6 wherein the elongate flexible member further includes an irrigation conduit extending from the proximal end to the distal end and for fluid connection with a fluid source.

28. The biopsy instrument of claim 6 further including a cover positionable between an open position displaced from the screen and a closed position overlaying the screen.

29. The biopsy instrument of claim 28 wherein the cover is slidably attached to one of the catcher body or catcher handle.

30. The biopsy instrument of claim 28 wherein the cover is rotatably attached to one of the catcher body or catcher handle.

31. The biopsy instrument of claim 28 wherein the catcher body with the cover in a closed position overlaying the screen fits a pathology processing cartridge.

32. The biopsy instrument of claim 6 wherein the screen includes a plurality of perforations.

33. The biopsy instrument of claim 6 wherein the securing end is for insertion into the access opening and complements the access opening to provide a seal therewith.

34. The biopsy instrument of claim 33 wherein at least one flexible ring encircles the securing end for providing a seal with the access opening.

35. The biopsy instrument of claim 6 wherein a portion of the catcher body complements the access opening to provide a seal therewith.

36. The biopsy instrument of claim 6 wherein the catcher body is removably attached to the catcher handle.

37. The biopsy instrument of claim 28 wherein the catcher handle, the catcher body, the cover and a cover hinge are integrally molded.

38. The biopsy instrument of claim 37 wherein deformation of the material of the cover hinge permits the cover to rotate from an open position to a closed position.

39. The biopsy instrument of claim 37 wherein at least one flexible ring encircles one of the catcher handle or catcher body for providing a seal with the access opening.

46. The method of claim 35 wherein the step of displacing the actuator in a first direction relative to the actuation handle causes the second jaw to rotate relative to the flexible member and away from the first jaw, and the step of displacing the actuator in a second direction relative to the actuation handle causes the second jaw to rotate relative to the flexible member and towards the first jaw.

47. The method of claim 36 wherein the flexible member includes an irrigation conduit in fluid connection with a fluid source and further including providing irrigation fluid from a distal end of the irrigation conduit to a tissue sample site, wherein the initiated vacuum effect draws irrigation fluid and the tissue sample through the aspiration conduit and suction passageway to the screen of the sample collector.

48. The method of claim 37 wherein the step of displacing the actuator in a second direction relative to the actuation handle further includes forming a substantially fluidtight passageway in the distal assembly.

8. A method of retrieving a biopsy sample using a biopsy instrument having a distal end, a proximal end, a distal assembly, an elongate flexible member extending from the distal end to the proximal end and including an aspiration conduit, a proximal actuation handle with a suction passageway in fluid connection with the aspiration conduit, the suction passageway at least partially defined by a wall extending laterally to the suction passageway and having an access opening located in the wall, the suction passageway for fluid connection with a vacuum source, and a sample collector having a catcher handle and a catcher body with a screen, the method comprising the steps of:

engaging the sample collector into the access opening;

inserting the distal end of the biopsy instrument into a patient;

positioning the distal assembly proximate the tissue to be sampled;

obtaining a tissue sample using the distal assembly;

initiating a vacuum effect in the suction passageway and the aspiration conduit to draw the tissue sample into the catcher body; and

disengaging the sample collector from the access opening.

9. The method of claim 8 wherein the step of obtaining further includes the substep of establishing a temporary vacuum effect in the aspiration conduit to pull the tissue to be severed into the distal assembly.

10. The method of claim 8 wherein the step of inserting further includes the substep of introducing a remote end of an irrigation endoscope into the patient, and the step of obtaining further includes the substep of providing irrigation fluid from the remote end of the irrigation endoscope to a tissue sample site, wherein the initiated vacuum effect draws irrigation fluid and the tissue sample through the aspiration conduit and suction passageway to the screen of the sample collector.

11. The method of claim 8 wherein the step of obtaining further includes the substeps of:

displacing an actuator in a first direction relative to the actuation handle, thereby causing a control member connected to the actuator to move relative to the flexible member, thereby causing a first jaw of the distal assembly connected to the control member to rotate relative to the flexible member and away from a second jaw of the distal assembly;

siting the first and second jaws on opposite sides of the tissue to be sampled; and

displacing the actuator in a second direction relative to the actuation handle, thereby causing the control member connected to the actuator to move relative to the flexible member, thereby causing the first jaw of the distal assembly connected to the control member to rotate relative to the flexible member and towards the second jaw of the distal assembly.

12. The method of claim 11 wherein the step of displacing the actuator in a first direction relative to the actuation handle causes the second jaw to rotate relative to the flexible member and away from the first jaw, and the step of displacing the actuator in a second direction relative to the actuation handle causes the second jaw to rotate relative to the flexible member and towards the first jaw.

40. The method of claim 8, further including establishing a temporary vacuum effect in the aspiration conduit to pull the tissue to be severed into the distal assembly.

41. The method of claim 8 further including placing a cover over the screen to entrap a tissue sample.

42. The method of claim 41 further including disconnecting the catcher body from the catcher handle.

43. The method of claim 8 further including introducing a remote end of an irrigation endoscope into the patient, and providing irrigation fluid from the remote end of the irrigation endoscope to a tissue sample site, wherein the initiated vacuum effect draws irrigation fluid and the tissue sample through the aspiration conduit and suction passageway to the screen of the sample collector.

44. The method of claim 8 further including the step of engaging a second sample collector into the access opening of the proximal actuation handle, and the step of repeating the inserting, obtaining, initiating, and disengaging steps for retrieving subsequent tissue samples without removing the biopsy instrument from the patient.

45. The method of claim 8 further including:

displacing an actuator in a first direction relative to the actuation handle, thereby causing a control member connected to the actuator to move relative to the flexible member, thereby causing a first jaw of the distal assembly connected to the control member to rotate relative to the flexible member and away from a second jaw of the distal assembly;

siting the first and second jaws on opposite sides of the tissue to be sampled; and

displacing the actuator in a second direction relative to the actuation handle, thereby causing the control member connected to the actuator to move relative to the flexible member, thereby causing the first jaw of the distal assembly connected to the control member to rotate relative to the flexible member and towards the second jaw of the distal assembly.

13. A biopsy instrument having a distal end and a proximal end, the biopsy instrument comprising:

a distal assembly for use in a surgical operation, the distal assembly including a movable jaw pivotably coupled to a distal end conduit, the distal assembly forming a fluid passageway in a closed configuration;

an elongate flexible member connected to and extending from the distal assembly toward the proximal end, the flexible member having an aspiration conduit in fluid connection with the distal end conduit for permitting the passage of matter from the distal end toward the proximal end;

a proximal actuation handle including an actuation device, the actuation handle being connected to the proximal end of the flexible member and having a suction passageway in fluid connection with the aspiration conduit, the suction passageway for fluid connection with a vacuum source and having a lateral access opening for receiving a sample collector;

a control member coupled to the actuation device and to the movable jaw of the distal assembly such that actuation of the actuation device pivots the movable jaw relative to the flexible member, thereby opening and closing the distal assembly.

14. The biopsy instrument of claim 13 wherein the distal assembly further includes a second movable jaw pivotably coupled to the distal end conduit, and the control member is further coupled to the second movable jaw such that actuation of the actuation device pivots the first and second movable jaws relative to the flexible member, thereby opening and closing the distal assembly.

15. The biopsy instrument of claim 13 further including a sample collector positionable within the lateral access opening of the suction passageway.

49. The biopsy instrument of claim 13 wherein the distal assembly provides a substantially fluidtight passageway coupled over the distal end of the aspiration conduit when the distal assembly is in a closed configuration.

50. The biopsy instrument of claim 13 wherein the flexible member further includes an irrigation conduit in fluid connection with the distal end conduit and for fluid connection with a fluid source, and wherein the distal assembly provides a substantially fluidtight passageway coupled over the distal end of the aspiration conduit and the distal end of the irrigation conduit when the distal assembly is in a closed configuration.

51. The biopsy instrument of claim 13 wherein the control member includes a pair of pull wires.

52. The biopsy instrument of claim 14 wherein the first and second movable jaws are hermaphroditic.

53. The biopsy instrument of claim 52 wherein the first and second movable jaws have sharp cutting edges.

54. The biopsy instrument of claim 52 wherein the first and second movable jaws have teeth for grasping.

55. The biopsy instrument of claim 52 wherein the first and second movable jaws have mating edges with complementary profiles.

56. The biopsy instrument of claim 15 wherein the sample collector includes a catcher handle with a securing end, a catcher body with a screen, the catcher body for insertion into the access opening, being attached to the securing end of the catcher handle, and being positionable within the suction passageway upon insertion into the access opening.

57. The biopsy instrument of claim 56 wherein the sample collector further includes a cover positionable between an open position displaced from the screen and a closed position overlaying the screen.

58. The biopsy instrument of claim 13 wherein the actuation device includes an actuator spool formed from two hermaphroditic halves.

59. The biopsy instrument of claim 58 wherein the actuation device further includes a swash plate for coupling the control member to the actuation device.

60. The biopsy instrument of claim 13 wherein the proximal actuation handle further includes a valve for selectively opening and closing the suction passageway, thereby selectively providing a vacuum effect within the aspiration conduit.

61. The biopsy instrument of claim 59 wherein the proximal actuation handle further includes a spring biased lever for operating the valve.

16. A method of retrieving a biopsy sample using a biopsy instrument having a distal end, a proximal end, a distal assembly, an elongate flexible member extending from the distal end to the proximal end and including an aspiration conduit, a proximal actuation handle with a suction passageway in fluid connection with the aspiration conduit, the suction passageway having an access opening and for fluid connection with a vacuum source, and a sample collector having a catcher handle and a catcher body with a screen, the method comprising the steps of:

engaging the sample collector into the access opening of the proximal actuation handle;

inserting the distal end of the biopsy instrument into a patient;

positioning the distal assembly proximate the tissue to be sampled;

obtaining a tissue sample using the distal assembly;

initiating a vacuum effect in the suction passageway and the aspiration conduit to draw the tissue sample into the catcher body; and

disengaging the sample collector from the proximal actuation handle, wherein the step of obtaining further includes establishing a temporary vacuum effect in the aspiration conduit to pull the tissue to be severed into the distal assembly.

17. A method of retrieving a biopsy sample using a biopsy instrument having a distal end, a proximal end, a distal assembly, an elongate flexible member extending from the distal end to the proximal end and including an aspiration conduit, a proximal actuation handle with a suction passageway in fluid connection with the aspiration conduit, the suction passageway having an access opening and for fluid connection with a vacuum source, and a sample collector having a catcher handle and a catcher body with a screen, the method comprising the steps of:

engaging the sample collector into the access opening of the proximal actuation handle;

inserting the distal end of the biopsy instrument into a patient;

positioning the distal assembly proximate the tissue to be sampled;

obtaining a tissue sample using the distal assembly;

initiating a vacuum effect in the suction passageway and the aspiration conduit to draw the tissue sample into the catcher body; and

disengaging the sample collector from the proximal actuation handle, wherein the step of inserting further includes introducing a remote end of an irrigation endoscope into the patient, and the step of obtaining further includes providing irrigation fluid from the remote end of the irrigation endoscope to a tissue sample site, wherein the initiated vacuum effect draws irrigation fluid and the tissue sample through the aspiration conduit and suction passageway to the screen of the sample collector.

18. A method of retrieving a biopsy sample using a biopsy instrument having a distal end, a proximal end, a distal assembly, an elongate flexible member extending from the distal end to the proximal end and including an aspiration conduit, a proximal actuation handle with a suction passageway in fluid connection with the aspiration conduit, the suction passageway having an access opening and for fluid connection with a vacuum source, and a sample collector having a catcher handle and a catcher body with a screen, the method comprising the steps of:

engaging the sample collector into the access opening of the proximal actuation handle;

inserting the distal end of the biopsy instrument into a patient;

positioning the distal assembly proximate the tissue to be sampled;

obtaining a tissue sample using the distal assembly;

initiating a vacuum effect in the suction passageway and the aspiration conduit to draw the tissue sample into the catcher body; and

disengaging the sample collector from the proximal actuation handle, wherein the step of obtaining further includes;

displacing an actuator in a first direction relative to the actuation handle, thereby causing a control member connected to the actuator to move relative to the flexible member, thereby causing a first jaw of the distal assembly connected to the control member to rotate relative to the flexible member and away from a second jaw of the distal assembly;

siting the first and second jaws on opposite sides of the tissue to be sampled; and

displacing the actuator in a second direction relative to the actuation handle, thereby causing the control member connected to the actuator to move relative to the flexible member, thereby causing the first jaw of the distal assembly connected to the control member to rotate relative to the flexible member and towards the second jaw of the distal assembly.

19. The method of claim 18 wherein the step of displacing the actuator in a first direction relative to the actuation handle causes the second jaw to rotate relative to the flexible member and away from the first jaw, and the step of displacing the actuator in a second direction relative to the actuation handle causes the second jaw to rotate relative to the flexible member and towards the first jaw.

24. The sample collector of claim wherein at least one flexible ring encircles the securing end for providing a seal with the access opening.