Surgical and pharmaceutical site access guide and methods

• US 6,203,524 B1
• Filed: 08/04/1998
• Issued: 03/20/2001
• Est. Priority Date: 02/10/1997
• Status: Expired due to Term

• Current Assignee: Hsvit, LLC
• Original Assignee: EMC Corporation (Dell Technologies Inc.)
• Inventors: Miller, Michael E., Schroeder, David L., Burney, Bryan T.
• Primary Examiner(s): Nguyen, Dinh X.
• Application Number:
  US09/117,755
• Time in Patent Office: 959 Days
• Field of Search: 604/93.01, 604/164.01, 604/164.04, 604/264, 604/158, 604/159, 604/162, 604/163, 128/898
• 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 a first 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 anatomical distal end secured to the first end of said cannula and a proximal end configured to pierce tissue, said distal end of said tip sloped to form a ramp adjacent and inclined toward said lateral opening; and

ablation means for ablating said lesion through said cannula, said means disposed in said lumen for transport through said lateral opening to the lesion.

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 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.

9. The system of claim 1 further comprising a plurality of depth markings located in spaced relation on said cannula.

10. The system of claim 9 wherein said markings are radiographic.

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

an introducer having

a cannula having a first end and a second end and defining a lumen therebetween opening at a first 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 anatomical distal end secured to the first end of said cannula and a proximal end configured to pierce tissue, said distal end of said tip sloped to form a ramp adjacent and inclined toward said lateral opening; and

a radiopharmaceutical composition disposed within said lumen for transport through said lateral opening to the lesion.

12. The system of claim 11 wherein said composition includes Iodine-125.

13. The system of claim 12 wherein said composition includes Palladium-103.

14. The system of claim 12 wherein said composition includes radioactive seeds.

15. 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.

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 visualization agent disposed within said cannula.

17. The system of claim 16 wherein said agent is a contrast agent.

18. The system of claim 17 wherein said agent is methylene blue.

19. 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.

20. The method of claim 19 wherein the second site is located in a plane defined by the first site and the introducer.

21. 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.

22. 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.

23. The method of claim 22 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.

24. The method of claim 23, 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.

25. The introducer of claim 24 further comprising a plurality of depth markings located in spaced relation on said cannula.

26. The introducer of claim 25 wherein said markings are radiographic.

27. The introducer of claim 24, further comprising:

a closed tip disposed at the first end of the cannula, said tip having a distal end disposed within said lumen and sloped to form said ramp.