Tissue accessing and anchoring device and method

• US 6,679,851 B2
• Filed: 06/12/2001
• Issued: 01/20/2004
• Est. Priority Date: 09/01/1998
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Burbank, Fred H., Quick, Richard L., Wardle, John, Louw, Frank, Lubock, Paul
• Primary Examiner(s): Winakur, Eric F.
• Assistant Examiner(s): McCrosky, David J.
• Application Number:
  US09/880,218
• Publication Number:
  US 20020058884A1
• Time in Patent Office: 952 Days
• Field of Search: 600/562-579
• US Class Current: 600/564
• CPC Class Codes: A61B 10/02 Instruments for taking cell samples or for biopsy A61B10/0038 and A61B10/0045 take precedence; needle locating or guiding means A61B17/3403; samplers for enzymology or microbiology C12M1/26; sampling or preparing biological specimens G01N33/48
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/148 having a short, rigid shaft for accessing the inner body transcutaneously, e.g. for neurosurgery or arthroscopy
• CPC Class Codes: A61B 18/1482 having a long rigid shaft for accessing the inner body transcutaneously in minimal invasive surgery, e.g. laparoscopy
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/1815 using microwaves
• CPC Class Codes: A61B 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/00115 with audible or visual output
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61B 2018/00208 actively driven, e.g. by a motor
• CPC Class Codes: A61B 2018/00273 Anchoring means for temporary attachment of a device to tissue
• CPC Class Codes: A61B 2018/00333 Breast
• CPC Class Codes: A61B 2018/00577 Ablation
• CPC Class Codes: A61B 2018/00601 Cutting
• CPC Class Codes: A61B 2018/00916 with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/00958 for switching between different working modes of the main function
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2018/1425 : Needle
• CPC Class Codes: A61B 2018/1475 : Electrodes retractable in or deployable from a housing
• CPC Class Codes: A61B 2090/378 : using ultrasound
• CPC Class Codes: A61B 2090/3904 : specially adapted for marking specified tissue
• CPC Class Codes: A61B 2090/3908 : Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/392 : Radioactive markers
• CPC Class Codes: A61B 6/4258 : for detecting non x-ray radiation, e.g. gamma radiation A61B6/037 takes precedence
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers

Abstract

The invention provides systems, methods and a node accessing and anchoring device, comprising an elongated shaft, a tissue cutting member, at least one anchoring element extending from a position at or near the distal end of the shaft; and a radiation detector. The radiation detector is effective to locate and identify sentinel lymph nodes following injection of radioactive material into a primary lesion site within a patient. The tissue cutting member, which may be activated with radio frequency energy, is effective to allow access of the elongated shaft to a sentinel lymph node. The anchoring elements are effective to anchor the device to or adjacent a sentinel lymph node accessed by the device. Anchoring elements may assume radially, longitudinally, or mixed radially and longitudinally curved or coiled configurations when deployed.

Claims

1. A tissue accessing and anchoring device, comprising:

a. an elongated shaft having a distal end and a proximal end;

b. a tissue cutting member at the distal end of the shaft to provide access to a target site;

c. at least one movable sheath having a distal end at or near the distal end of the shaft, a port in the distal end of the sheath and an inner bore leading to and in fluid communication with the port in the distal end; and

d. at least one anchoring element which is slidably disposed within the inner bore of the sheath and positioned at or near the distal end of the shaft, which is configured to move within said inner bore, to extend out of the port in the distal end of the movable sheath, beyond the distal end of the shaft and which is configured to extend into tissue at the target site to thereby anchor the device.

2. The accessing and anchoring device of claim 1 wherein the extended anchoring element forms a curved structure as it extends out the port in the distal end of the sheath.

3. The accessing and anchoring device of claim 2 wherein the curved structure comprises a helical coil.

4. The accessing and anchoring device of claim 2 wherein the curved structure of the anchoring element extends through at least 180°

.

5. The accessing and anchoring device of claim 2 wherein the curved structure of the anchoring element extends through at least 360°

.

6. The accessing and anchoring device of claim 2 wherein the curved structure of the anchoring element extends through at least 540°

.

7. The accessing and anchoring device of claim 1 wherein the anchoring element extends radially from the shaft.

8. The accessing and anchoring device of claim 7 wherein the anchoring element comprises a helical coil.

9. The accessing and anchoring device of claim 1 wherein the anchoring element extends longitudinally.

10. The accessing and anchoring device of claim 9 wherein the anchoring element comprises a helical coil.

11. The accessing and anchoring device of claim 1 wherein the elongated shaft has an inner lumen extending to a location at or near the distal end of the shaft.

12. The accessing device of claim 11 wherein a radiation detector is provided on a distal extremity of an elongated member slidably disposed within the inner lumen of the elongated shaft.

13. The accessing and anchoring device of claim 1 wherein the tissue cutting member on the distal end of the shaft is an electrode.

14. The accessing and anchoring device of claim 13 wherein the electrode has an electrically active surface.

15. The accessing and anchoring device of claim 14 wherein the electrically active surface has a sharp edge.

16. The accessing and anchoring device of claim 13 wherein the tissue cutting electrode is configured to be electrically connected to an RF energy source.

17. The accessing and anchoring device of claim 13 wherein an electrosurgical cutting edge of the cutting member is spaced from the distal end of the shaft.

18. The accessing and anchoring device of claim 13 wherein an electrosurgical cutting edge has an arcuate shape.

19. The accessing and anchoring device of claim 1, having at least two radially extending anchoring elements.

20. The accessing and anchoring device of claim 1, having at least three radially extending anchoring elements.

21. The accessing and anchoring device of claim 19 wherein the radially extending anchoring elements extend along a substantial length of the shaft.

22. The accessing and anchoring device of claim 21 wherein the substantial length of the elongate shaft through which the anchoring elements extend has an oblong transverse cross section.

23. A tissue accessing and anchoring device, comprising:

a. an elongated shaft having a distal end, a proximal end and at least a distal portion having an oblong transverse cross section along the length thereof;

b. a tissue cuffing member at or beyond the distal end of the shaft to provide access to a target site;

c. a plurality of movable sheaths each having a distal end at or near the distal end of the shaft, a port in the distal end of the sheath and an inner bore leading to and in fluid communication with the port in the distal end; and

d. a plurality of elongated anchoring elements, each of which is configured to move within the inner bore of a sheath, to extend from the port in the distal end of the movable sheath along the portion of the elongated shaft having an oblong transverse cross section, to extend beyond the distal end of the shaft and which is configured to extend into tissue at the target site to thereby anchor the device.

24. The tissue accessing and anchoring device of claim 23 wherein the plurality of elongated anchoring elements extending along said length of the shaft having an oblong transverse cross section are parallel and extend along a long dimension of the oblong transverse cross section.

25. A node accessing and anchoring device comprising:

an elongated shaft having a longitudinal axis, a distal end and a proximal end;

a tissue cutting member at the distal end of the shaft;

a movable sheath having an inner bore;

at least one radially extending anchoring element which is configured to extend into tissue at a target site and which is disposed within said inner bore of said movable sheath at or near the distal end of the shaft, the at least one radially extending anchoring element having a retracted configuration and a deployed configuration extending from the distal end of the shaft; and

a deployment actuator disposed proximal of the distal end of the elongate shaft and configured to deploy the radially extending anchoring element from a retracted configuration to an extended configuration.

26. The node accessing and anchoring device of claim 25, wherein the anchoring element forms a curved structure as it extends radially.