Single-Insertion, Multiple Sampling Biopsy Device With Linear Drive

• US 20080306406A1
• Filed: 08/10/2006
• Published: 12/11/2008
• 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 8,262,585 B2
• Time in Patent Office: Days
• US Class Current: 600/567
• 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 2090/3987 Applicators for implanting markers
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers

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 single-insertion, multiple sampling biopsy device, comprising:

an outer cannula extending along a longitudinal axis from a proximal end to a distal end, the outer cannula having a first port;

a stylet disposed in the outer cannula and configured to translate along the longitudinal axis towards the distal and proximal ends in the outer cannula, the stylet having a second port;

a sheath disposed between the outer cannula and the stylet, the sheath configured to translate along the longitudinal axis towards the distal and proximal ends;

a bulkhead disposed in the stylet and configured to translate with the stylet along the longitudinal axis towards the distal and proximal ends; and

a drive unit coupled to at least one of the outer cannula, stylet, and sheath to transmit motive force to at least one of the outer cannula, stylet, and sheath to move at least the stylet relative to the outer cannula.

2. The device of claim 1, where the bulkhead includes one or both of vacuum and pressurized fluid supply in fluid communication with a passage formed through the bulkhead.

3. The device of claim 1, further comprising a fluid passage defined by the inner surface of the stylet and the outer surface of bulkhead, the fluid passage in fluid communication with one or more of a pressurized fluid supply and vacuum supply.

4. The device of claim 2, where the sheath comprises a plurality of lands and openings that define a rack to engage with a pinion of the drive unit.

5. The device of claim 4, where the sheath comprises a selection mechanism to select between a first configuration where the sheath is coupled to the stylet to move as a single unit and a second configuration where the stylet is uncoupled from the sheath so that the sheath is movable independently of the stylet

6. The device of claim 5, where the sheath encloses the second port of the stylet to define a volume bounded by a rear bulkhead of the tip, the inner surface of the tip and the bulkhead.

7. The device of claim 6, where the stylet tip includes a marker disposed in the tip, the marker being ejected from the tip in an operative condition of the device.

8. The device of claim 1, where the stylet tip includes a marker mounted on the outer surface of the tip, the marker being separated from the tip in an operative condition of the device.

9. The device of claim 1, where the marker can be one or more of a hooked marker, helical marker and serrated edge marker.

10. The device of claim 1, where the marker can be an annular marker or a split-ring marker.

11. A method of sampling biological tissue with a biopsy device having three elongated members at least two of which translate along a longitudinal axis between a distal end and a proximal end, the method comprising:

capturing a biological sample in a chamber defined by two of the elongated members; and

translating the two elongated members as a single unit through the interior of a third elongated member to deliver the biological sample from the distal end to the proximal end.

12. A single-insertion, multiple sampling biopsy device, comprising:

a sheath extending along a longitudinal axis from a proximal end to a distal end, the sheath having a sample recess space therewithin;

the sheath being selectively configurable to open and close the sample recess space;

the sheath carrying a movable first bulkhead therewithin and located at a distal end of the sample recess;

the sheath having a sample recovery port located proximal of the sample acquisition port; and

a drive unit coupled to the first bulkhead to move it from the distal end of the sheath to the sample recovery port such that a sample received in the sample recess is transported to the sample recovery port.

13. The device of claim 12, further comprising a second bulkhead, located on a side of the sample recess opposite the first bulkhead, the second bulkhead having a port connected to a source of vacuum and/or pressurized fluid.

14. The device of claim 13, wherein the second bulkhead is connected to the drive unit to move with the first bulkhead.

15. The device of claim 12, wherein the sheath contains first and second elements that move independently in distal and proximal directions relative to the sheath, the directions being collinear with an axis of the sheath, and wherein the first and second elements form respective parts of a cylindrical conduit connected at a proximal end to a vacuum source and connected at a distal end to the sample recess.

16. The device of claim 15, wherein the sheath is directly adjacent the first and second independently movable elements wherein the sheath holds the first and second independently movable elements in alignment.

17. The device of claim 15, wherein the first and second independently movable elements are hemicylinders.

18. The device of claim 12, further comprising a selective engagement device and wherein the sheath contains first and second elements that move independently in distal and proximal directions, the directions being collinear with an axis of the sheath, and wherein selective engagement device interconnects the first and second elements, the drive unit being connected to move one of the first and second elements and to move the other of the first and second elements selectively depending on whether the engagement device is engaged to interconnect the first and second elements.

19. The device of claim 12, wherein the sheath contains first and second elements that move independently in distal and proximal directions relative to the sheath and wherein the first bulkhead is connected to one of the first and second elements.

20. The device of claim 12, where the sheath comprises a selection mechanism to select between a first configuration where the sheath is coupled to the stylet to move as a single unit and a second configuration where the stylet is uncoupled from the sheath so that the sheath is movable independently of the stylet.

21. The device of claim 12, where the bulkhead carries a cutting tip.

22. The device of claim 12, further comprising a selective engagement device and wherein the sheath contains first and second elements that move independently in distal and proximal directions, the directions being collinear with an axis of the sheath, and further comprising a cutting tip extending distally of a distal terminus of the sheath, the cutting tip being connected to one of the first and second elements.

23. The device of claim 12, further comprising a selective engagement device and wherein the sheath contains first, second, and third elements, the first and second of which move independently in distal and proximal directions, the directions being collinear with an axis of the sheath, the third element being parallel and substantially coextensive with the first and second elements along an axis of the sheath, the third element having a cutting tip extending distally of a distal terminus of the sheath.

24. The device of claim 23, where the tip includes a marker mounted on the outer surface of the tip, the marker being separated from the tip in an operative condition of the device.

25. The device of claim 24, where the marker is one or more of a hooked marker, helical marker and serrated edge marker.

26. The device of claim 24, where the marker is an annular marker or a split-ring marker.

27. The device of claim 12, wherein the sheath includes a cutting blade a distal end thereof.

28. The device of claim 27, wherein the sheath is connected to the drive unit which drives the cutting blade over the sample recess.

29. A method of sampling biological tissue with a biopsy device having first and second elongate members that translate within a third elongate along a longitudinal axis between a distal end and a proximal end, the method comprising:

capturing a biological sample in a chamber defined between the first and second elongated members; and

translating the first and second elongate members as a single unit through the interior of the third elongate member to deliver the biological sample from the distal end of the third elongate member to the proximal end of the third elongate member.

30. The method of claim 29, further comprising translating the first and second elongated members through the third elongated member in a reverse direction to repeat the capture and translation of another sample.

31. The method of claim 29, further comprising cutting the sample from a host by translating the third elongate member relative to the first and second elongate members, the third elongate member having a cutting edge at a distal end thereof that effects the cutting.

32. A method of transporting a tissue-containing chamber with a biopsy device having four elongated members that extends along a longitudinal axis between a distal end and a proximal end, the method comprising:

exposing a first aperture of a first sheath and a second aperture of a second sheath, the second sheath having a chamber defined by a first bulkhead, a second bulkhead and a floor portion of the second sheath;

providing a vacuum proximate the second aperture;

enclosing the second aperture of the second sheath with a third sheath; and

translating the chamber defined by the second and third sheaths through a substantial portion of a fourth sheath to expose the chamber in a third aperture formed through the fourth sheath.

33. A single-insertion, multiple sampling biopsy device, comprising:

an outer cannula extending along a longitudinal axis from a proximal end to a distal end, the outer cannula having a cutting distal end and a side port arranged proximal of the distal end;

a cutting tip supported by twin longitudinal members that remains stationary relative to the outer cannula, and the two internal retracting longitudinal members;

a first sheath within the outer cannula, with a distal beveled end, that translates in the distal and proximal directions;

a second sheath within the outer cannula configured to translate along a longitudinal axis between the distal and proximal ends, and said sheath having distal and proximal bulkheads that form a tissue accepting recess, the proximal bulkhead also forming a fluid passage in communication with the proximal end;

a drive unit to translate and revolve the outer cannula relative to the three inner members; and

a drive unit to translate the first and second sheaths relative to the cutting tip and outer cannula where the two sheaths can translate relative to each other in a predetermined relationship.

34. A single-insertion, biopsy device, comprising:

a cannula having a proximal end, a distal end, an extraction position at the distal end and a recovery opening at the proximal end;

first and second elongate elements having distal ends;

the first and second elongate element distal ends being movable between the extraction position of the cannula and the recovery opening of the cannula;

the first and second elongate elements further being movable with respect to each other to define extraction and closed configurations, in the extraction configuration, the first and second elongate element distal ends defining a recess at the extraction position, the recess having an access and in the closed configuration, the first and second elongate element distal ends being mutually opposite to surround a volume; and

a drive unit coupled to the first and second elongate elements to configure them between the open configuration and the closed configuration and to move the first and second elongate element distal ends from the extraction position to the recovery opening.

35. The device of claim 34, wherein the drive unit moves the first and second elongate element distal ends to the recovery opening after placing the first and second elongate elements in the closed configuration.

36. The device of claim 35, wherein the drive unit configures the first and second elongate elements into the open configuration after moving their distal ends to the recovery opening.

37. The device of claim 34, wherein the cannula has a cutting edge at a distal end thereof, the drive unit moving the cannula to place the cutting edge over the recess at the extraction position.

38. A method of taking a biopsy tissue sample, comprising:

receiving a sample in a stylet, held within a cutting cannula, while the stylet and cutting cannula are inserted in a host; and

moving the stylet, relative to the cutting cannula, repeatedly from a sample receiving position to a sample recovery position, while maintaining the cutting cannula in place within the host.

39. The method of claim 38, wherein the stylet has a cutting tip affixed thereto such that the cutting tip is moved with the stylet.

40. The method of claim 38, wherein the receiving includes receiving the sample adjacent a bulkhead affixed to the stylet, the bulkhead pushing the sample as the stylet is moved.

41. The method of claim 38, further comprising applying a vacuum to the stylet where the sample is received and cutting the sample free of the host.

42. The method of claim 38, further comprising extending a cover over the sample before moving the stylet relative to the cutting cannula.

43. The method of claim 42, wherein the extending includes axially moving an elongate member relative to the stylet and the cutting cannula, the elongate member forming a portion of a cylinder with a major portion of the stylet, the cylinder being coaxially arranged within the cutting cannula.

44. The method of claim 38, further comprising deploying a tissue marker from a tip of the stylet.

45. A method of taking a biopsy tissue sample, comprising:

receiving a sample in a stylet, held within a cutting cannula, while the stylet and cutting cannula are inserted in a host;

extending a cover over the sample; and

moving the stylet relative to the cutting cannula from a sample receiving position to a sample recovery position, while maintaining the cutting cannula in place within the host.

46. The method of claim 45, further comprising repeating receiving another sample and extending a cover and moving the stylet.

47. The method of claim 45, wherein the stylet has a cutting tip affixed thereto such that the cutting tip is moved with the stylet.

48. The method of claim 45, wherein the receiving includes receiving the sample adjacent a bulkhead affixed to the stylet, the bulkhead pushing the sample as the stylet is moved.

49. The method of claim 45, further comprising suctioning the sample into a recess in the stylet and cutting the sample free of the host.

50. The method of claim 45, wherein the extending includes axially moving an elongate member relative to the stylet and the cutting cannula, the elongate member forming a portion of a cylinder with a major portion of the stylet, the cylinder being coaxially arranged within the cutting cannula.

51. The method of claim 45, further comprising deploying a tissue marker from a tip of the stylet.

52. The method of claim 45, further comprising partially retracting the cover to partially expose the sample while forcing a quantity of pressurized fluid into a space below the cover to eject the sample from the stylet.

53. A biopsy device, comprising:

a stylet having a sample recess at a distal end and a cannula having sample acquisition port and a sample recovery port;

the stylet being movable within the cannula to move its sample recess from the sample acquisition port to the sample recovery port;

a cover member, movable relative to the stylet, to cover the sample recess selectively;

a transport mechanism connected to move the stylet and cover, the transport mechanism covering the sample recess when a sample is received thereat and moving the sample recess such that a sample in the sample recess is prevented from rubbing against the cannula; and

the transport mechanism moving the cover to uncover the sample recess to recover the sample when the sample is moved to the recovery port.

54. The device of claim 53, wherein the sample recess is only partially uncovered at the recovery port while the transport mechanism conveys fluid under pressure to the sample recess to eject the sample.

55. The device of claim 53, wherein the stylet has a cutting tip affixed thereto such that the cutting tip is moved with the stylet.

56. The device of claim 53, wherein the transport mechanism creates a vacuum in the stylet sample recess to urge tissue into it and moves the cannula relative to the sample recess to cut a sample.

57. The device of claim 53, further comprising a housing enclosing the transport mechanism and at least portions of the stylet and cannula, the housing having a total volume of no more than 500 cubic centimeters.

58. A method of taking a biopsy tissue sample, comprising:

covering a sample with a cover member in a sample recess while moving the recess within a cannula, to prevent the sample from frictionally engaging the cannula;

and partially uncovering the sample recess at a sample recovery position while injecting fluid under pressure to remove the sample from the sample recess.