Surgical and pharmaceutical site access guide and methods

• US 6,228,049 B1
• Filed: 09/02/1998
• Issued: 05/08/2001
• Est. Priority Date: 02/09/1996
• Status: Expired due to Term

• Current Assignee: Promex Technologies LLC
• Original Assignee: Promex SA (Uzinsider SA)
• Inventors: Mark, Joseph L., Ireland, Dan C., Schroeder, David L.
• Primary Examiner(s): Nguyen, Dinh X.
• Application Number:
  US09/145,419
• Time in Patent Office: 979 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 10/0283 with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe A61B10/025, A61B10/0266 take precedence
• CPC Class Codes: A61B 17/3417 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: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter

Abstract

An introducer guide 15 for introducing medical items into an internal tissue of a patient is provided. The guide 15 includes a cannula 20 defining a lumen sized to receive the item and a lateral opening 24. A ramp is disposed within the lumen adjacent and inclined toward the lateral opening 24. A hub 40′ is attached to the second end 22 of the cannula 20. The hub 40′ includes a gripping portion 41′ configured to be held when inserting and positioning the introducer 15. The gripping portion 41′ has a length l_gp sufficient for gripping and a tactile indicator 44 disposed along substantially the entire length l_gp of the gripping portion 41 on the hub 40′. The indicator 44 has a fixed angular relationship with the lateral opening 24. The invention also includes methods for obtaining a biopsy sample and methods for treating lesions.

Claims

1. An introducer guide for introducing medical items into an internal tissue of a patient, comprising:

a cannula having a first end and a second end and defining a lumen therebetween opening at an aperture at said second end, said lumen sized to receive the item, said cannula defining a lateral opening in communication with said lumen adjacent said first end, said lumen sized and configured to allow exit of the item;

a ramp disposed within said lumen adjacent and inclined toward said lateral opening; and

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 gripping portion having a length sufficient for gripping, 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 the item to said lumen; and

a tactile indicator disposed along substantially the entire length of said gripping portion on said hub, said indicator having a fixed angular relationship with said lateral opening.

2. The introducer guide of claim 1 wherein said tactile indicator is a raised rib.

3. The guide introducer of claim 2 wherein said tactile indicator is rounded.

4. The guide introducer of claim 2 wherein said rib has a width less than a third of a diameter of said gripping portion of said hub and a height greater than said width.

5. The guide introducer of claim 1 wherein said tactile indicator is aligned with said lateral opening.

6. The guide introducer of claim 1 further comprising a flange projecting from said hub at a location anatomically distal from said gripping portion.

7. The guide introducer of claim 1, further comprising 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 said ramp adjacent and inclined toward said lateral opening.

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

providing a biopsy introducer, the 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;

a ramp disposed within the 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; and

a hub attached to the second end of the cannula, the hub including a gripping portion configured to be held when inserting and positioning the introducer, the gripping portion having a length sufficient for gripping, the 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 the item to the lumen; and

a tactile indicator disposed along the length of the gripping portion on the hub, the indicator having a fixed angular relationship with the lateral opening;

inserting the first end of the cannula into the patient at the biopsy site;

tactically sensing the tactile indicator while gripping the hub when the first end of the cannula is inserted into the patient;

after tactically sensing the tactile indicator, rotating the cannula to orient the lateral opening in a desired direction;

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.

9. The method of claim 8, further comprising:

removing the biopsy needle from the introducer after withdrawing the biopsy needle from the biopsy site and while leaving the introducer inserted into the tissue;

clearing the sample from the biopsy needle;

tactically sensing the tactile indicator while gripping the hub;

rotating the introducer to orient the lateral opening in a second desired direction;

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 though 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.

10. The method of claim 8, further comprising:

tactically sensing the tactile indicator and 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.

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

providing a guide introducer, the 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;

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;

a hub attached to the second end of the cannula, the hub including a gripping portion configured to be held when inserting and positioning the introducer, the gripping portion having a length sufficient for gripping, the 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 the item to the lumen; and

a tactile indicator disposed along substantially the entire length of the gripping portion on the hub, the indicator having a fixed angular relationship with the lateral opening;

inserting the first end of the cannula into the patient at the site;

tactically sensing the tactile indicator while gripping the hub and while the first end of the cannula is inserted into the patient;

manipulating the cannula while tactically sensing the tactile indicator to place the lateral opening adjacent the site; and

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 to contact the site with the item.

12. The method of claim 11 wherein the item is an ablating chemical composition.

13. The method of claim 11 wherein the item is a radiopharmaceutical composition.

14. The method of claim 11 wherein the item is a contrast agent.

15. The method of claim 11, further comprising:

tactically sensing the indicator while rotating the cannula;

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.

16. An introducer guide for introducing medical items into an internal tissue of a patient, comprising:

a cannula having a first end and a second end and defining a lumen therebetween opening at a first aperture at said first end and a second aperture at said second end, said lumen sized to receive the item, said cannula defining a lateral aperture through a side of said cannula, said aperture sized to and configured to allow exit of the item;

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 gripping portion having a length sufficient for gripping, said hub defining a channel having a first end and a second end, the first end of the channel in communication with said second aperture for delivering the item to said lumen; and

positive tactile indicator means for positively indicating the direction of said aperture.

17. The introducer guide of claim 16 wherein said positive tactile indicator means includes a raised rib disposed along said length of said hub, said rib having a fixed angular relationship with said lateral aperture.

18. The introducer guide of claim 17 wherein said rib has a width less than a third of a diameter of said gripping portion of said hub and a height greater than said width.

19. The introducer guide of claim 18 wherein said lateral aperture is in communication with said first aperture of said cannula to form an oblong aperture.

20. The introducer guide of claim 19 wherein said cannula is a prostate seeding needle.

21. A hub for a needle device, the needle device having a cannula having a sidewall with a first end and a second end, the cannula defining a first aperture and a second aperture at the second end, the needle defining a lumen therethrough in communication with the first and second apertures, said hub comprising:

a hub body defining a channel having a first end and a second end, said first end of said channel communicable with the second aperture of the needle for delivering an item to the lumen of the needle;

a gripping portion on an outer surface of said hub body configured to be grasped, said gripping portion having a length sufficient for gripping;

a positive tactile indicator disposed along said length of said gripping portion on said hub, said indicator having a width less than a third of a diameter of said gripping portion of said hub and a height greater than said width; and

means for fixing said hub to the needle device with said indicator in a fixed angular relationship to a feature laterally disposed on the cannula.

22. The hub of claim 21 wherein the feature is the first aperture of the needle and the first aperture is defined in the sidewall of the cannula.

23. The hub of claim 21 wherein the feature is the first aperture of the needle and the first aperture is oblong and defined at the first end and extending into the sidewall of the cannula.

24. The hub of claim 21 wherein said positive tactile indicator means includes a raised rib disposed along said length of said hub.

25. The hub of claim 24 wherein said rib has a width less than a third of a diameter of said gripping portion of said hub and a height greater than said width.