Surgical and pharmaceutical site access guide and methods

• US 20010001811A1
• Filed: 01/11/2001
• Published: 05/24/2001
• Est. Priority Date: 02/09/1996
• Status: Active Grant

• Current Assignee: Hsvit, LLC
• Original Assignee: Bryan T. Burney, David L. Schroeder, Michael E. Miller
• Inventors: Burney, Bryan T., Miller, Michael E., Schroeder, David L.
• Granted Patent: US 6,447,477 B2
• Time in Patent Office: Days
• US Class Current: 604/93.01
• CPC Class Codes: A61B 10/0233 Pointed or sharp biopsy instruments
• CPC Class Codes: A61B 10/0266 means for severing sample
• 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 17/3401 Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia local anaesthesia A61M19/00
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 2010/0225 for taking multiple samples
• CPC Class Codes: A61B 2090/3908 Soft tissue, e.g. breast tissue
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter

Abstract

A guide (100) is provided for biopsy and microtherapy which includes an introducer cannula (120) defining a lumen (125) sized to receive a diagnostic or therapeutic item therethrough and a lateral opening (124) in communication with the lumen (125) adjacent the first end (121) of the cannula (120). The invention also includes a solid tip (130) having an anatomically distal end (131) secured to the first end (121) of the cannula (120) and a proximal end (132) configured to pierce tissue. A ramp (135) is disposed within the cannula (120) at an end (136) of the lateral opening (124) adjacent the first end (121) of the cannula (120). The ramp (135) is inclined toward the lateral opening (124), whereby the item will be deflected through the lateral opening (124) as it advances within the lumen (125) and exits the cannula (120). In some embodiments, the item is a biopsy needle, ablation means or a radiopharmaceutical seed. The invention also includes methods of obtaining a biopsy sample and methods for treating lesions.

Claims

1. A system for diagnosing and treating a lesion inside a patient, comprising:

a guide having

a cannula having a first end and a second end and defining a lumen therebetween opening at an aperture at said second end,

said cannula defining a lateral opening in communication with the lumen adjacent said first end, and

a solid tip having an anatomically distal end secured to the first end of said cannula and a proximal end configured to pierce tissue; and

ablation means for ablating said lesion through said cannula.

2. The system of

claim 1

wherein said ablation means includes an ablation chemical.

3. The system of

claim 2

wherein said composition is an alcohol.

4. The system of

claim 3

wherein said composition is ethanol.

5. The system of

claim 2

wherein said composition is cyanoacrylate.

6. The system of

claim 1

further comprising biopsy means for obtaining a biopsy sample of the lesion, said biopsy means insertable through said aperture, said lumen and said lateral opening;

7. The system of

claim 6

wherein said biopsy means comprises a hollow biopsy needle having an anatomically proximal end and a distal end, said needle sized and configured to be movably and rotatably received within said lumen, said proximal end sized and configured to exit from said lumen through said lateral opening and having an edge to pierce tissue to obtain a biopsy sample when said biopsy needle is advanced into the tissue.

8. The system of

claim 7

wherein said distal end of said tip is sloped to form a ramp adjacent and inclined toward said lateral opening, whereby the biopsy needle will be deflected through said lateral opening as it exits said cannula.

9. The system of

claim 1

, further comprising:

an introducer stylet sized to be received within said lumen, said introducer stylet having a length sufficient to block said lateral opening when said introducer stylet is received within said lumen.

10. The system of

claim 1

further comprising a plurality of depth markings located in spaced relation on said cannula.

11. The system of

claim 10

wherein said markings are radiographic.

12. A system for treating a lesion within a patient'"'"'s body, comprising:

an introducer having

a cannula having a first end and a second end and defining a lumen therebetween,

the second end of the cannula defining an aperture,

said cannula defining a lateral opening in communication with the lumen adjacent said first end, and

a solid tip having an anatomically distal end secured to the first end of said cannula and a proximal end configured to pierce tissue; and

a radiopharmaceutical composition disposed within said cannula.

13. The system of

claim 12

wherein said composition includes Iodine-125.

14. The system of

claim 13

wherein said composition includes Palladium-103.

15. The system of

claim 13

wherein said composition includes radioactive seeds.

16. A system for diagnosing a lesion within a patient'"'"'s body, comprising:

an introducer having

a cannula having a first end and a second end and defining a lumen therebetween,

the second end of the cannula defining an aperture,

said cannula defining a lateral opening in communication with the lumen adjacent said first end, and

a solid tip having an anatomically distal end secured to the first end of said cannula and a proximal end configured to pierce tissue; and

a localization wire disposed within said cannula, said localization wire having a diameter that is smaller than a dimension of said lateral opening.

17. A system for diagnosing a lesion within a patient'"'"'s body, comprising:

an introducer having

a cannula having a first end and a second end and defining a lumen therebetween,

the second end of the cannula defining an aperture,

said cannula defining a lateral opening in communication with the lumen adjacent said first end, and

a solid tip having an anatomically distal end secured to the first end of said cannula and a proximal end configured to pierce tissue; and

a visualization agent disposed within said cannula.

18. The system of

claim 17

wherein said agent is a contrast agent.

19. The system of

claim 18

wherein said agent is methylene blue.

20. A method of delivering therapeutic items to a pathological site inside a patient'"'"'s body, comprising:

providing a guide introducer, said introducer having

a cannula having a first end and a second end and defining a lumen therebetween;

a tip disposed at the first end of the cannula and closing the lumen at the first end;

the lumen having an aperture at the second end of the cannula, the aperture sized and configured to receive an item; and

the cannula defining a lateral opening in communication with the lumen, the lateral opening sized and configured to allow exit of the item from the lumen;

inserting the introducer into the patient at the site;

inserting a first item through the aperture and into the lumen;

advancing the first item through the lumen and out through the lateral opening at an angle relative to the introducer and into the site; and

rotating the introducer after advancing the first item through the lumen;

inserting a second item through the aperture and into the lumen; and

advancing the second item through the lumen and out through the lateral opening at the same angle relative to the introducer to place the item at a location eccentric from the first site.

21. The method of

claim 20

wherein the second site is located in a plane defined by the first site and the introducer.

22. A method for treating a lesion inside a patient'"'"'s body, comprising:

providing an access guide introducer, the introducer having

a cannula having a first end and a second end and defining a lumen therebetween the lumen opening at an aperture at the second end,

a tip disposed at the first end of the cannula and closing the lumen at the first end, and

the cannula defining a lateral opening in communication with the lumen,

inserting the introducer into the patient near the lesion;

manipulating the introducer to place the lateral opening adjacent the lesion; and

advancing an ablating chemical composition through the lumen and out through the lateral opening to contact the lesion with the composition.

23. A method for diagnosing and treating a lesion inside a patient'"'"'s body, comprising:

providing an access guide introducer, the introducer having

a cannula having a first end and a second end and defining a lumen therebetween, the lumen opening at an aperture at the second end,

a tip disposed at the first end of the cannula and closing the lumen at the first end, and

the cannula defining a lateral opening in communication with the lumen;

inserting the introducer into the patient near the lesion;

manipulating the introducer to place the lateral opening adjacent the lesion;

inserting a biopsy needle having an anatomically proximal end and a distal end through the aperture and into the lumen;

advancing the biopsy needle through the lumen so that the proximal end of the biopsy needle projects through the lateral opening at an angle relative to the introducer and into a first lesion site to obtain a first biopsy sample;

withdrawing the proximal end of the biopsy needle from the first site and into the lumen of the introducer; and

advancing an ablating chemical composition through the lumen and out through the lateral opening to contact the lesion with the composition.

24. The method of

claim 23

further comprising:

rotating the introducer with the proximal end of the biopsy needle contained within the lumen and further advancing the biopsy device to eject the proximal end of the biopsy needle from the lumen through the lateral opening at the same angle relative to the introducer to a second lesion site to obtain a second sample from a location eccentric from the first site; and

withdrawing the proximal end of the biopsy needle from the second site into the lumen of the introducer.

25. The method of

claim 24

, further comprising:

withdrawing the biopsy needle from the lumen;

providing a second biopsy needle having a bend adjacent an anatomically proximal end of the needle, the bend deflecting the proximal end of the second needle at an angle away from a longitudinal axis of the second needle;

inserting the second needle through the aperture and into the lumen;

advancing the second needle so that the proximal end projects through the lateral opening at a different angle relative to the introducer to obtain a second sample.

26. A biopsy needle introducer, comprising:

a cannula having a first end and a second end and defining a lumen therebetween, the lumen sized to receive a biopsy needle therethrough;

the second end of the cannula defining an aperture, the aperture sized and configured to receive a biopsy needle for passage into the lumen;

said cannula defining a lateral opening in communication with the lumen adjacent said first end, the lateral opening sized and configured to allow exit of an anatomically proximal end of the biopsy needle from the lumen; and

a solid tip having an anatomically distal end secured to the first end of said cannula and a proximal end configured to pierce tissue.

27. The biopsy needle introducer of

claim 26

wherein the distal end of the tip is sloped to form a ramp adjacent and inclined toward the lateral opening, whereby a biopsy needle will be deflected through the lateral opening as it exits the cannula.

28. The biopsy needle introducer of

claim 27

wherein the distal end of the tip blocks a portion of the lateral opening.

29. The biopsy needle introducer of

claim 27

wherein the distal end of said tip has an outer diameter smaller than an inner diameter of the first end of the cannula and the distal end of said tip is at least partially disposed within said lumen at the first end of the cannula.

30. The biopsy needle introducer of

claim 29

wherein the tip is secured to the cannula by an interference fit.

31. The biopsy needle introducer of

claim 30

, wherein said said cannula is crimped onto said solid tip.

32. The biopsy needle introducer of

claim 29

wherein the tip is secured to the cannula by welding.

33. The biopsy needle device of

claim 29

wherein the tip is secured to the cannula with an adhesive.

34. The biopsy needle introducer of

claim 27

, further comprising:

an introducer stylet sized to be received within the lumen, the introducer stylet having a length sufficient to block the lateral opening when the introducer stylet is received within the lumen.

35. The biopsy needle introducer of

claim 34

, wherein the introducer stylet has an angled end configured to mate with the ramp when the introducer stylet is received in the cannula.

36. The biopsy needle introducer of

claim 26

, further comprising a hub attached to the second end of the cannula, said hub defining a channel having a first end and a second end, the first end in communication with the aperture for delivering a biopsy needle to the lumen.

37. The introducer of

claim 36

wherein said hub is funnel shaped, the first end of the channel having an interior radius that is smaller than an interior radius of the second end of the channel, the channel tapering from the second end of the channel to the first end of the channel to guide a biopsy needle from the hub to the lumen.

38. A biopsy device, comprising:

an introducer including

a cannula having a first end and a second end and defining a lumen therebetween,

a tip disposed at the first end of the cannula and closing the lumen,

the cannula defining an aperture at the second end of the cannula, the aperture sized and configured to receive a biopsy needle, and

said cannula defining a lateral opening in communication with the lumen adjacent said first end, the lateral opening sized and configured to allow exit of a biopsy needle from the lumen; and

a hollow biopsy needle having an anatomically proximal end and a distal end, said needle sized and configured to be movably and rotatably received within the lumen, the proximal end sized and configured to exit from said lumen through the lateral opening and having an edge to pierce tissue to obtain a biopsy sample when the biopsy needle is advanced into the tissue.

39. The biopsy device of

claim 38

, further comprising a ramp disposed within said cannula at an end of the lateral opening adjacent the first end of the cannula, said ramp being inclined toward the lateral opening, whereby said biopsy needle will be deflected through the lateral opening as it advances within the lumen and exits the cannula.

40. The biopsy device of

claim 39

, further comprising a hub attached to said second end, said hub defining a channel having a first end and a second end, the first end in communication with the aperture for delivering a biopsy needle to the lumen.

41. The biopsy device of

claim 40

wherein said hub is funnel shaped, the first end of the channel having an interior radius that is smaller than an interior radius of the second end of the channel, the channel tapering from the second end of the channel to the first end of the channel to guide a biopsy needle from the hub to the lumen.

42. The biopsy device of

claim 39

, further comprising an introducer stylet sized to be received within the lumen, the introducer stylet having a length sufficient to block the lateral opening when the introducer stylet is received within the lumen.

43. The biopsy device of

claim 42

, wherein said introducer stylet has an angled end configured to mate with said ramp when said introducer stylet is received in the cannula.

44. The biopsy device of

claim 39

wherein said needle includes a bend adjacent the proximal end of said needle, the bend deflecting the proximal end of said needle at an angle away from a longitudinal axis of said needle when said bend extends outside said cannula.

45. The biopsy device of

claim 39

, further comprising a biopsy needle stylet sized and configured to be received within said biopsy needle.

46. The biopsy device of

claim 45

wherein the biopsy needle stylet has a penetrating point that extends from the proximal end of the biopsy needle when the biopsy stylet is inserted into said biopsy needle.

47. The biopsy device of

claim 46

wherein the penetrating point is rounded.

48. The biopsy device of

claim 46

wherein the penetrating point has a trocar geometry.

49. A biopsy needle introducer, comprising:

a cannula having a first end and a second end and defining a lumen therebetween, the lumen sized to receive a biopsy needle therethrough;

the second end of the cannula defining an aperture, the aperture sized and configured to receive a biopsy needle;

a hub attached to the second end of the cannula, said hub including a gripping portion configured to be held when inserting and positioning the introducer, said hub defining a channel having a first end and a second end, the first end of the channel in communication with the aperture for delivering a biopsy needle to the cannula; and

a flange projecting from said hub at a location anatomically distal from the gripping portion, said flange configured to prevent inadvertent needle sticks when a biopsy needle is inserted into the introducer.

50. The introducer of

claim 49

wherein said hub is funnel shaped, the first end of the channel having an interior radius that is smaller than an interior radius of the second end of the channel, the channel tapering from the second end of the channel to the first end of the channel to guide a biopsy needle from the hub to the lumen.

51. The biopsy needle of

claim 49

further comprising a plurality of depth markings located in spaced relation on said cannula.

52. The biopsy needle of

claim 51

wherein said markings are radiographic.

53. The introducer of

claim 49

, further comprising:

a closed tip disposed at the first end of the cannula; and

said cannula defining a lateral opening in communication with the lumen, the lateral opening sized and configured to allow exit of an anatomically proximal end of the biopsy needle from the lumen.

54. The biopsy needle introducer of

claim 53

, further comprising a ramp disposed within said cannula at an end of the lateral opening adjacent said first end of said cannula, the ramp being inclined toward the lateral opening, whereby a biopsy needle will be deflected through the lateral opening as it exits the cannula.

55. The introducer of

claim 54

wherein said hub is funnel shaped, the first end of the channel having an interior radius that is smaller than an interior radius of the second end of the channel, the channel tapering from the second end of the channel to the first end of the channel to guide a biopsy needle from the hub to the lumen.

56. The biopsy needle of

claim 55

further comprising a plurality of depth markings located in spaced relation on said cannula.

57. The biopsy needle of

claim 56

wherein said markings are radiographic.

58. A method of obtaining a biopsy sample, comprising:

providing a biopsy introducer, said introducer having

a cannula having a first end and a second end and defining a lumen therebetween;

a tip disposed at the first end of the cannula and closing the lumen at the first end;

the lumen having an aperture at the second end of the cannula, the aperture sized and configured to receive a biopsy needle;

the cannula defining a lateral opening in communication with the lumen, the lateral opening-sized and configured to allow exit of a biopsy needle from the lumen; and

a ramp disposed within said cannula at an end of the lateral opening adjacent the first end of the cannula, the ramp being inclined toward the lateral opening, whereby a biopsy needle will be deflected through the lateral opening as it exits the cannula;

inserting the introducer into the patient at the biopsy site;

inserting a biopsy needle having an anatomically proximal end and a distal end through the aperture and into the lumen;

advancing the biopsy needle through the lumen so that the proximal end of the biopsy needle projects through the lateral opening at an angle relative to the introducer and into a first biopsy sample site to obtain a first biopsy sample; and

withdrawing the proximal end of the biopsy needle from the first biopsy sample site and into the lumen of the introducer.

59. The method of

claim 58

further comprising performing an imaging study to determine an appropriate needle path to the biopsy sample site.

60. The method of

claim 58

, further comprising:

inserting an introducer stylet into the cannula before inserting the introducer into the patient, the introducer stylet sized to be received within the lumen, the introducer stylet having a length such that it will block the lateral opening when the introducer stylet is received within the lumen to prevent tissue from entering the lateral opening when the cannula is introduced into the patient; and

removing the introducer stylet before inserting the biopsy needle into the introducer.

61. The method of

claim 58

further comprising:

applying suction to the biopsy needle to draw a first biopsy sample into the biopsy needle before withdrawing the biopsy needle from the first sample site.

62. The method of

claim 61

further comprising reciprocating the biopsy needle within the lumen while applying suction.

63. The method of

claim 61

further comprising:

inserting a biopsy needle stylet into the biopsy needle before inserting the biopsy needle into the lumen; and

removing the biopsy needle stylet before applying suction to the biopsy needle.

64. The method of

claim 58

, further comprising:

removing the biopsy needle from the introducer after withdrawing the biopsy needle from the biopsy site;

clearing the sample from the biopsy needle;

rotating the introducer;

reinserting the biopsy needle through the aperture and into the lumen after clearing the sample;

further advancing the biopsy device to eject the proximal end of the biopsy needle from the lumen through the lateral opening at the same angle relative to the introducer to obtain a second biopsy sample from a location eccentric from the first biopsy sample; and

withdrawing the proximal end of the biopsy needle from the biopsy sample site into the lumen of the introducer.

65. The method of

claim 58

, further comprising:

rotating the introducer with the proximal end of the biopsy needle contained within the lumen and further advancing the biopsy device to eject the proximal end of the biopsy needle from the lumen through the lateral opening at the same angle relative to the introducer to obtain a second biopsy sample from a location eccentric from the first biopsy sample; and

withdrawing the proximal end of the biopsy needle from the biopsy sample site into the lumen of the introducer.

66. The method of

claim 58

, further comprising:

withdrawing the biopsy needle from the lumen;

providing a second biopsy needle having a bend adjacent an anatomically proximal end of the needle, the bend deflecting the proximal end of the second needle at an angle away from a longitudinal axis of the second needle;

inserting the second needle through the aperture and into the lumen;

advancing the second needle so that the proximal end projects through the lateral opening at a different angle relative to the introducer to obtain a second biopsy sample.

67. The method of

claim 66

wherein the second biopsy sample site is located in a plane defined by the first biopsy sample site and the introducer.

68. A method of making a biopsy device, comprising:

providing a hollow cannula defining a lumen sized to receive a biopsy needle and a lateral opening at a first end of the cannula, the lateral opening in communication with the lumen, the lateral opening sized and configured to allow exit of an anatomically proximal end of the biopsy needle from the lumen;

attaching a hub to the second end of the cannula, the hub defining a channel in communication with the lumen; and

securing an anatomically distal end of a solid tip to the first end of the cannula, the tip having a proximal end configured to pierce tissue, the distal end of the tip being sloped to form a ramp adjacent to and inclined proximally toward said lateral opening, whereby a biopsy needle will be deflected as it advances through the lumen and exits the cannula through the lateral opening.

69. The method of

claim 68

wherein the distal end of the tip has an outer diameter smaller than an inner diameter of the first end of the cannula and the securing includes inserting the distal end of said tip into the first end of the cannula.

70. The method of

claim 69

wherein the securing includes employing an interference fit.

71. The method of

claim 69

wherein the securing includes welding.

72. The method of

claim 69

wherein the securing includes applying an adhesive.