Methods and apparatus for securing medical instruments to desired locations in a patient's body

• US 6,958,044 B2
• Filed: 12/04/2001
• Issued: 10/25/2005
• Est. Priority Date: 03/03/1998
• Status: Expired due to Term

• Current Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Original Assignee: Senorx Incorporated (Becton, Dickinson & Co)
• Inventors: Jones, Michael L., Burbank, Fred H., Quick, Richard L., Lubock, Paul
• Primary Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US10/004,987
• Publication Number:
  US 20020087095A1
• Time in Patent Office: 1,421 Days
• Field of Search: 600562-567, 606/167, 606/170, 606/41, 606 45- 50
• 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 10/0241 for prostate
• CPC Class Codes: A61B 10/0266 means for severing sample
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes 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 18/12 by passing a current through the tissue to be heated, e.g. high-frequency current
• CPC Class Codes: A61B 18/14 Probes or electrodes therefor
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 18/1487 Trocar-like, i.e. devices producing an enlarged transcutaneous opening
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• 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 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00267 having a basket shaped structure
• 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 2018/00898 : Alarms or notifications created in response to an abnormal condition
• CPC Class Codes: A61B 2018/0091 : Handpieces of the surgical instrument or device
• CPC Class Codes: A61B 2018/00916 : with means for switching or controlling the main function of the instrument or device
• CPC Class Codes: A61B 2018/1253 : monopolar
• CPC Class Codes: A61B 2018/126 : bipolar
• 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 2018/162 : located on the probe body
• CPC Class Codes: A61B 2090/3908 : Soft tissue, e.g. breast tissue
• CPC Class Codes: A61B 2090/3987 : Applicators for implanting markers
• CPC Class Codes: A61B 2090/3991 : having specific anchoring means to fixate the marker to the tissue, e.g. hooks
• CPC Class Codes: A61B 90/17 : for soft tissue, e.g. breast-holding devices
• CPC Class Codes: A61B 90/37 : Surgical systems with images on a monitor during operation
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers

Abstract

Devices and methods are provided for securely affixing a medical instrument to desired tissue in a patient'"'"'s body, using a fixation agent. Such medical instruments may comprise localization wires or tissue acquisition instruments, such as biopsy instruments, for example. In the case of tissue acquisition instruments, the inventors have discovered significant advantages for securely affixing the distal end of the tissue acquisition instrument to a particular tissue target area. For example, such an approach permits the imaging environment to be uncoupled from the procedural environment so that expensive and often unavailable imaging equipment, such as stereotactic imaging equipment, need not be used. In a preferred embodiment, a bonding agent, such as adhesive, surgical glue, or a solvent, is used as the fixation agent.

Claims

1. A medical device for localization of tissue at a target site within a patient'"'"'s body, comprising:

a shaft having a distal shaft portion with a distal tip, and being configured for placement within the patient'"'"'s body at target site;

a radially expandable side-cutting element which has an expanded configuration for cutting a tissue sample from target tissue and which is disposed on said shaft proximal of said distal tip;

a first fixation element which extends away from the distal shaft portion in a proximal direction, which has a free end, which has another end secured to the distal shaft portion proximal of said distal tip and which is configured for securing the distal shaft portion of said medical device within tissue at said target site; and

a second fixation element which extends away from the distal shaft portion in a distal direction, which has a free end, which has another end secured to the distal shaft portion proximal of said distal tip and which is configured for securing the distal shaft portion of said medical device within tissue at said target site.

2. The medical device of claim 1, wherein said radially expandable side-cutting element is an electrosurgical cutting element.

3. The medical device of claim 1, wherein the free ends of said fixation elements are configured for penetrating tissue at the target site.

4. The medical device of claim 1, wherein said fixation element have a radially retracted configuration for delivery and a radially extended configuration for deploying the free end into tissue at the target site.

5. The medical device of claim 4, wherein a plurality of radially extendable and retractable first and second fixation elements are provided.

6. A method for acquiring a tissue specimen from a target site, comprising:

a) providing a tissue acquisition device having a shaft with a distal end with a distal tip, a proximal end, a distal cutting element disposed on said distal tip, a distal shaft portion, at least one first fixation element which extends away from the distal shaft portion in a proximal direction, which has a free end configured to engage target tissue, which has another end secured to the distal shaft portion at a location spaced proximally from the distal tip and which has a radially retracted configuration for delivery and a radially extended configuration for deploying the free end into tissue at the target site and at least one second fixation element which extends away from the distal shaft portion in a distal direction, which has a free end configured to engage target tissue, which has another end secured to the distal shaft portion at a location spaced proximally from the distal tip and which has a radially retracted configuration for delivery and a radially extended configuration for deploying the free end into tissue at the target site,

b) placing the distal end of the shaft within a patient'"'"'s body, so that the distal tip is disposed distally adjacent the target site;

c) securing the distal end of the shaft within the target site by extending into tissue at the target site the free ends of first and second fixation elements; and

d) separating a tissue specimen at the target site.

7. The method of claim 6, wherein the tissue acquisition device has a plurality of fixation elements which extend from a location on the distal shaft portion spaced proximal to the distal end into tissue at the target site.

8. A method of performing a medical procedure at a target site within a patient'"'"'s body, comprising:

a) providing a medical device comprising a shaft having a distal shaft portion with a distal tip, a first fixation element which extends away from the distal shaft portion in a proximal direction, which has a free end and another end secured to the distal shaft portion proximal to the distal tip, a second fixation element which extends away from the distal shaft portion in a distal direction, which has a free end and another end secured to the distal shaft portion proximal to the distal tip and a radially expandable side-cutting element configured for cutting a tissue sample and disposed on said distal shaft portion proximal of said distal tip;

b) advancing the distal shaft portion within a patient'"'"'s body, so that the distal shaft portion is disposed within the target site; and

c) extending into the target tissue the free ends of the first and second fixation elements so that the distal shaft portion becomes secured within tissue at the target site.

9. The method of claim 8, wherein said fixation elements have radially retracted configurations for delivery and radially extended configurations for deploying the free ends thereof into tissue at the target site.

10. The method of claim 8, wherein said medical device comprises a plurality of radially extendable and retractable first and second fixation elements.

11. A method for acquiring a specimen of tissue from a target site, comprising:

a) providing a tissue acquisition device comprising a shaft having a distal end with a distal tip, a fixation element which has a free end and which is spaced proximal to the distal tip, and a radially expandable side-cutting element configured for cutting a tissue specimen and disposed on said shaft proximal of said distal tip;

b) advancing the distal end of the shaft within a patient'"'"'s body, so that the distal end is disposed within tissue at the target site;

c) securing the distal end of the shaft within the tissue at the target site by extending into the tissue the free end of the fixation element; and

d) cutting tissue with said radially expandable side-cutting element effective to separate one or more tissue specimens from the target site.

12. The method of claim 11, wherein the distal end of the shaft is secured within tissue at the target site by extending a plurality of radially extendable and retractable fixation elements from a side of a distal shaft portion spaced proximal to the distal end.

13. A medical device for localization of tissue at a target site comprising:

a shaft having a distal portion with a distal tip, and being configured for placement of said distal portion into a patient'"'"'s body at a desired location;

a distal cutting element disposed on said distal tip;

a radially expandable side-cutting element configured for cutting a tissue sample from target tissue and disposed on said shaft proximal of said distal tip; and

a fixation element which has a free end, which is disposed on said distal portion proximal of said distal tip and which is configured for securing the distal portion of said medical device within tissue at the target site.

14. The medical device of claim 13, wherein said radially expandable side-cutting element is an electrosurgical cutting element.

15. The medical device of claim 13, wherein said distal cutting element is an electrosurgical cutting element.

16. The medical device of claim 13, wherein said fixation element is configured for penetrating tissue.

17. The medical device of claim 13, including a plurality of radially extendable and retractable fixation elements.

18. The medical device of claim 13, wherein said fixation element comprises a plurality of radially extendable and retractable members which are radially extendable and retractable from a side of the distal portion of the shaft, and which have free ends configured for securing the distal portion of the shaft adjacent target tissue.

19. A method of performing a medical procedure, comprising:

a) providing a medical device comprising a shaft having a distal end with a distal tip, a distal cutting element on the distal tip, a radially expandable side-cutting element which is configured for cutting a tissue sample and which is disposed on said shaft proximal of said distal tip, and a fixation element which has a free end, which is spaced proximal to the distal tip and which is configured for engaging tissue,

b) advancing the medical device within a patient'"'"'s body while cutting through tissue with said distal cutting element until the distal end of the shaft is disposed within target tissue; and

c) extending into the target tissue the free end of the fixation element so that the distal end of the shaft becomes secured within the target tissue.

20. The method of claim 19, wherein said fixation element comprises at least one radially extendable and retractable member.

21. The method of claim 20, wherein said fixation element comprises a plurality of radially extendable and retractable members.

22. The method of claim 19, wherein said distal cutting element is an electrosurgical cutting element.

23. The method of claim 19, wherein said cutting step comprises cutting target tissue.

24. The method of claim 19, wherein said cutting step comprises cutting through target tissue.

25. The method of claim 24, wherein the distal end of the shaft is placed within a patient'"'"'s body so that the distal tip of the distal end is disposed adjacent and distal to target tissue.