SINGLE-INSERTION, MULTIPLE SAMPLING BIOPSY DEVICE USABLE WITH VARIOUS TRANSPORT SYSTEMS AND INTEGRATED MARKERS

• US 20090227893A1
• Filed: 08/10/2006
• Published: 09/10/2009
• Est. Priority Date: 08/10/2005
• Status: Active Grant

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Thompson, Stanley O., Taylor, Jon, Coonahan, Timothy J.
• Granted Patent: US 8,282,574 B2
• Time in Patent Office: Days
• US Class Current: 600/566
• CPC Class Codes: A61B 10/0275 with sample notch, e.g. on the side of inner stylet
• CPC Class Codes: A61B 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2090/3904 specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 2090/3991 having specific anchoring means to fixate the marker to the tissue, e.g. hooks

Abstract

The present invention provides for exemplary embodiments of a single-insertion, multiple sampling biopsy device. Exemplary embodiments of a single-insertion, multiple sampling device with integrated marker release.

Claims

1. A biopsy device comprising:

a stylet having a distal end and a proximal end, the stylet having a sample opening and an interior volume adjacent its distal end, the opening providing access to the interior volume, the stylet having a recovery position proximal of the distal end;

a first shuttle mounted in the stylet and free to travel from the sample opening to the recovery position, the shuttle having at least one bulkhead shaped and positioned to push a sample in the shuttle toward the proximal end of the stylet; and

a transport subassembly coupled to the shuttle at least one bullhead to move a tissue sample from the sample port to the proximal end of the stylet.

2. The device of claim 1, further comprising a second shuttle nested at least partly within the first.

3. The device of claim 2, wherein the transport subassembly moves the first shuttle and the second shuttle consecutively to transport respective samples.

4. The device of claim 1, wherein the shuttle has a distal bulkhead having a surface at least partly normal to a direction of travel thereof.

5. The device of claim 1, further comprising a second shuttle nested at least partly within the first, each shuttle having a distal bulkhead that has a surface at least partly normal to a direction of travel thereof.

6. The device of claim 1, wherein the transport subassembly includes a spooling tape that winds and unwinds to transport the shuffle in proximal and distal directions, respectively.

7. The device of claim 1, wherein the transport subassembly includes a spooling tape that winds and unwinds to transport the shuttle in proximal and distal directions, respectively, the shuttle being defined by a distal portion of the tape.

8. The device of claim 1, wherein the transport subassembly has a loop that runs between the opening and the recovery position, the shuttle being connected to the loop and the transport subassembly winding the loop to transport the shuttle through the stylet.

9. The device of claim 8, wherein the stylet has a recovery port at the recovery position, the device further comprising a recovery member with an engaging surface, the recovery member being movable within the shuttle while at the recovery position so as to cause the engaging surface to move from a position in the shuttle toward the recovery port, whereby a sample in the shuttle may be removed from the shuttle through the recovery port.

10. The device of claim 1, wherein the transport subassembly includes a linear actuator.

11. The device of claim 10, wherein the stylet has an internal surface with internal threads, the linear actuator includes a threaded cylindrical member having external threads that mesh with the stylet internal threads, the threaded cylindrical member being rotatable within the stylet and rotatably coupled to the first shuttle.

12. The device of claim 10, wherein the stylet has an internal surface with internal threads, the linear actuator includes a threaded cylindrical member having external threads that mesh with the stylet internal threads, the threaded cylindrical member being rotatable within the stylet and rotatably coupled to the first shuttle and the first shuttle has a member in engagement with the stylet that prevents the rotation of the first shuttle within the stylet.

13. The device of claim 10, wherein the linear actuator includes threaded cylindrical members having external and internal threads distributed among them such that when the cylindrical members are nested, one within another, mating pairs of the external and internal threads are in mesh, one of the cylindrical members being rotatably coupled to the first shuttle.

14. The device of claim 10, wherein the linear actuator includes threaded cylindrical members having external and internal threads distributed among them such that when the cylindrical members are nested, one within another, mating pairs of the external and internal threads are in mesh, one of the cylindrical members being rotatably coupled to the first shuttle;

and the first shuttle has a member in engagement with the stylet that prevents the rotation of the first shuttle within the stylet.

15. A biopsy device comprising:

a stylet having a distal end and a proximal end, the stylet having a sample opening and an interior volume adjacent its distal end, the opening providing access to the interior volume, the stylet having a recovery position proximal of the distal end;

a resilient tape with a distal end, the tape distal end being guided by the stylet and movable therealong in proximal and distal directions;

the stylet having an edge guide that receives the tape distal end and which, when the tape distal is moved in the distal direction, the edge guide shapes the tape distal end into an open shape that defines a recess to allow a sample to be received in the recess; and

the tape distal end returning to a closed shape when moved proximal of the edge guide thereby securing the sample for transport.

16. A biopsy device comprising:

a stylet having a distal end and a proximal end, the stylet having a sample opening near the distal end and a recovery position near the proximal end;

the stylet having an interior volume adjacent the stylet distal end, the opening providing access to the interior volume;

a cassette with multiple recesses each having an access and a fluid-permeable blind end, the cassette positioned at the recovery position to align a selected one of the cassette recesses with the recovery position such that the selected cassette recess is in fluid communication with the interior volume of the stylet; and

a transport mechanism that forces a fluid from the stylet distal end toward the stylet proximal end such that fluid exits the blind end of the selected cassette recess, whereby a specimen is flushed into the selected cassette recess and is caught by it.

17. The device of claim 16, wherein the transport mechanism includes a storage container and transports fluid from the storage container to the stylet distal end.

18. The device of claim 16, wherein the transport mechanism includes:

a reservoir, a pump, and a multi-way valve;

the stylet including a fluid lumen adjacent the interior volume;

the three way valve connecting the fluid lumen, the reservoir, and the pump;

the transport mechanism operating the pump and the multi-way valve to transport fluid from the reservoir to the stylet distal end during a transport cycle and to recover fluid remaining in the fluid lumen by returning the fluid to the reservoir, during a reset cycle.

19. The device of claim 16, wherein the cassette recesses are linked together by flexible connections to form a bandolier.

20. The device of claim 16, further comprising a vacuum source, the transport mechanism including a vacuum connection from the vacuum source to the selected recess blind end to aid in drawing a specimen into the selected recess.

21. The device of claim 16, wherein the further comprising a vacuum source, the transport mechanism including a vacuum connection from the vacuum source to the selected recess blind end, the vacuum source and the transport mechanism being housed in a self-contained handheld unit with a volume of less than 500 cubic centimeters.

22. The device of claim 16, wherein the stylet has two parallel lumens, a primary lumen for transporting specimens and a secondary lumen for conveying fluid a proximal end of the stylet to the distal end of the stylet where the fluid returns through the primary lumen.

23. The device of claim 22, wherein the stylet has a sample opening for receiving specimens from a host at its distal end and the stylet carries a cutting cannula that surrounds the stylet and selectively covers the sample opening, the drive mechanism conveying fluid to transport specimens only when the cutting cannula covers the sample opening.

24. A biopsy device, comprising:

a biopsy sample extraction needle with a sample extraction end, recovery end, and a transport channel linking the extraction and recovery ends;

a pump with a multi-way valve; and

a fluid reservoir linked to the transport channel and pump such that the pump;

draws a vacuum at least the transport end with the multi-way valve in a first setting;

draws fluid from the reservoir with the multi-way valve in a second setting, and

flushes the transport channel from the extraction end to the recovery end to transport a sample through the transport channel with the multi-way valve in a third setting.

25. The device of claim 24, where the first and third multi-way valve settings are identical.

26. The device of claim 24, where the pump is a syringe.

27. The device of claim 24, where the pump can recover residual saline from the transport channel and deliver it to the reservoir.

28. The device of claim 24, further comprising a volume-reducing valve that selectively reduces a total sealed volume in fluid with the recovery end such that a vacuum drawn by the pump is greater when the volume-reducing valve is engaged.

29. A biopsy device, comprising:

a biopsy needle with a tissue extraction portion and a recovery portion, remote from the tissue extraction portion, with a channel connecting the tissue extraction portion and the recovery portion;

the tissue extraction portion having a receiving lumen and a cutting blade;

a syringe and a flow controller having a first configuration in which the syringe draws a vacuum at the tissue extraction portion which draws tissue from a host into the receiving portion; and

the syringe and flow controller having a second configuration in which the syringe flushes fluid from the tissue extraction portion to the recovery portion to transport tissue samples thereto.

30. The device of claim 29, further comprising a disposable component that is provided as a sterilized single-use component which includes the syringe and a durable component that houses a motor to drive the syringe.

31. The device of claim 29, wherein the syringe and flow controller have a third configuration in which the syringe draws fluid from a reservoir before flushing the fluid from the tissue extraction portion to the recovery portion.

32. The device of claim 29, further comprising a housing containing the syringe, the flow controller and at least a portion of the biopsy needle, the housing having a total volume of no more than 500 cubic centimeters.

33. A biopsy device comprising:

a stylet having distal and proximal ends, a harvest position, at the distal end, where tissue samples are received, and a delivery position proximal of the harvest position;

the stylet having a marker held at the stylet distal end;

a transport member within the stylet, the transport member being movable in an axial direction between the harvest and delivery positions to receive samples at the harvest end and deliver samples at the delivery end; and

the transport member being further movable beyond the harvest position, or further movable in a direction other than the axial direction, to push at least a portion of the marker to a position that causes the marker to be deployed.

34. The device of claim 33, where the transport member is further movable beyond the harvest position to push at least a portion of the marker to a position that causes the marker to be deployed.

35. The device of claim 33, where the transport member is further movable in a direction other than the axial direction to push at least a portion of the marker to a position that causes the marker to be deployed.

36. The device of claim 33, where the marker includes a wire coil which is housed by the stylet prior to deployment and which is deployed by rotating the transport member around the axial direction.

37. The device of claim 33, where the transport member has a distal edge having a recess, the marker includes a hook which is housed by the stylet prior to deployment and which is deployed by rotating the transport member around the axial direction to move the recess away from the marker such that when the transport member is advanced distally, the marker is pushed by the distal edge.

38. The device of claim 33, where the stylet has a tip and the marker includes a deformable member that is elastically secured to the tip, the marker being deployable by moving the transport member beyond the harvest position to push the marker from the tip.

39. The device of claim 33, where the stylet has a tip and the marker includes a split ring that is elastically secured to the tip, the marker being deployable by moving the transport member beyond the harvest position to push the marker from the tip.

40. The device of claim 33, where the stylet has a tip and the marker includes a flexible member that is elastically secured to the tip, the marker being deployable by moving the transport member beyond the harvest position to push the marker from the tip.

41. The device of claim 33, where the transport member has a distal tip with a ramp and the marker has a deformable part that is proximal of the ramp, the transport member causing the deformable part to deform when the transport member is moved proximally of the harvest position.

42. The device of claim 33, where the transport member has a distal tip with a ramp and the marker has a blooming part that is proximal of the ramp, the transport member causing the deformable part to bloom when the transport member is moved proximally of the harvest position.

43. A method of performing a tissue biopsy, comprising:

severing a tissue sample from a host within a shuttle located inside a biopsy needle, the shuttle being movable within the biopsy needle;

holding the tissue sample in the shuttle while moving the shuttle from a distal end of the biopsy needle to a proximal end to transport the tissue sample; and

repeating the severing and holding steps without removing the biopsy needle from the host.

44. The method of claim 43, wherein the shuttle is connected to a loop and the moving includes revolving the loop around endpoints located at the distal and proximal ends.

45. The method of claim 43, further comprising extending a removal member into the shuttle at the proximal end and removing it from the shuttle.

46. The method of claim 43, further comprising applying a vacuum to the biopsy needle prior to severing the tissue sample.

47. The method of claim 43, wherein the moving of the shuttle includes retracting a linear actuator.

48. The method of claim 43, wherein the moving of the shuttle includes rotating a threaded lumen to which the shuttle is threaded.

49. The method of claim 43, wherein a first instance of the severing and holding steps to transport a first sample is done with a different shuttle from a second instance.

50. The method of claim 43, wherein moving the shuttle includes separating it from a nested set of shuttles.

51. A method of performing a tissue biopsy, comprising:

transporting an excised tissue sample to the end of a flat elongate member held within a biopsy needle; and

the transporting including wrapping the end of the elongate member over the sample to prevent it from rubbing against the biopsy needle.

52. The method of claim 51, wherein the elongate member is elastic at its end and the wrapping is a result of the release of a deformation of the elongate member end.

53. The method of claim 51, wherein the transporting includes wrapping the elongate member about a spool.

54. A method of performing a tissue biopsy, comprising:

drawing a vacuum in a biopsy needle with a pump to move a portion of a host to be sampled into the biopsy needle for excision; and

transporting an excised sample of the host through the needle by flushing fluid from the pump.

55. The method of claim 54, wherein the pump is a syringe.

56. The method of claim 54, wherein the pump has a chamber and the vacuum is drawn by expanding the chamber and the fluid is flushed by compressing the chamber.

57. The method of claim 54, wherein the pump has a chamber and the vacuum is drawn by expanding the chamber and the flushing includes filling the chamber by expanding it while in fluid communication with a fluid reservoir and subsequently compressing the chamber to expel the fluid.

58. A method of performing a tissue biopsy, comprising:

cutting a tissue sample by axially moving a cutting cannula of a biopsy needle relative a stylet that holds a sample within the cutting cannula in a first direction;

deploying a marker by moving the at least a portion of the stylet in a second direction relative to the cutting cannula.

59. The method of claim 58, wherein marker is a split ring held on the stylet until pushed off by the cutting cannula.

60. The method of claim 58, wherein the marker is a hook and the deploying is performed by rotating a shuttle held by the stylet.

61. A multiple sample biopsy device, comprising:

a sampling mechanism that cuts tissue samples;

a flexible sock wrapped over a support so as to define a recess holding open an access to the sock; and

a transport mechanism that conveys a first tissue sample into the recess of the sock and partially everts by pulling a blind end thereof thereby extending a length of the recess to provide room for another sample and simultaneously transporting the first tissue sample along a direction of the pulling.

62. The device of claim 61, wherein the sampling mechanism includes a hollow cannula having an interior, the sock being located in the interior.

63. The device of claim 61 in which the sock is of a mesh.

64. The device of claim 61 wherein the sock is porous and the transport mechanism conveys tissue samples into the recess by flushing against the sample pushing it into the recess and wherein the fluid flows out of the sock.

65. A multiple sample biopsy device, comprising:

a sampling mechanism that cuts tissue samples;

a flexible sock with an access to the sock interior, the sock being an elongate member having a longitudinal axis; and

a transport mechanism that conveys a first tissue sample into the recess of the sock after a first tissue sample is cut and conveys a second tissue sample into the recess of the sock after the second tissue sample is cut such that the tissue samples are arranged in a row along the longitudinal axis.

66. The device of claim 65, wherein the sampling mechanism includes a hollow cannula having an interior, the sock being located in the interior.

67. The device of claim 65, wherein the sock is of a mesh.

68. The device of claim 65, wherein the sock is porous and the transport mechanism conveys tissue samples into the recess by flushing against the sample pushing it into the recess and wherein the fluid flows out of the sock.

69. The device of claim 65, wherein when the transport mechanism conveys a first tissue sample into the recess of the sock, it partially everts the sock by pulling a blind end thereof thereby extending a length of the recess to provide room for the second sample and simultaneously transports the first tissue sample along a direction of the pulling.

70. The device of claim 65, wherein when the transport mechanism conveys a first tissue sample into the recess of the sock, it partially everts the sock by pulling a blind end of the sock along the longitudinal axis thereof, thereby extending a length of the recess to provide room for the second sample and simultaneously transports the first tissue sample along the longitudinal axis.

71. A method of performing a tissue biopsy, comprising:

in a biopsy needle, cutting a succession of tissue samples and forcing each in turn into a sock, aligning them along the length of the sock; and

removing the biopsy needle and recovering the tissue samples by removing the sock.

72. The method of claim 71, wherein the order of the samples in the sock at the end of the method corresponds to the order in which the samples were cut.

73. A multiple sample biopsy device, comprising:

a sampling mechanism that cuts tissue samples;

a chain of paddles connected together such that they can be nested together and pulled as a chain by expanding the chain by pulling only one of the paddles;

the sampling mechanism conveying a first tissue sample adjacent a first one of the paddles on a proximal side thereof;

a drive that moves the first one in the proximal direction less than a distance required for the first one to engage a second adjacent one of the paddles such that the first paddle moves the first tissue sample proximally without causing the second paddle to move;

the sampling mechanism conveying a second tissue sample adjacent a second one of the paddles on a proximal side thereof; and

the drive moving the second one in the proximal direction less than a distance required for the second one to engage a third adjacent one of the paddles such that the first and second paddles move the first and second tissue samples, respectively, without causing a third of the paddles to move.

74. The device of claim 73, wherein the sampling mechanism includes a hollow cannula having an interior, the chain of paddles being arranged in a series within and along the interior.