Methods and apparatus for securing medical instruments to desired locations in a patients body

• US 6,540,693 B2
• Filed: 09/01/1998
• Issued: 04/01/2003
• 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): Hindenburg, Max F.
• Assistant Examiner(s): WINGOOD, PAMELA LYNN
• Application Number:
  US09/146,185
• Publication Number:
  US 20020007130A1
• Time in Patent Office: 1,673 Days
• Field of Search: 600/562, 600/564-567, 600/585
• 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 target tissue comprising:

a shaft having a distal end with a distal tip and having a cutting element; and

at least one radially extendable fixation member which has a free end, which is spaced proximal from the distal tip and which is radially extendable from a side of the distal end of the shaft to secure the distal end of the shaft within target tissue.

2. The medical device as recited in claim 1, wherein said medical device comprises a surgical instrument.

3. The medical device as recited in claim 1, wherein the radially extendable and retractable member comprises a radially extendable and retractable wire.

7. The tissue acquisition instrument as recited in claim 1, wherein said mechanical fixation agent comprises a tube and plurality of radially expandable flaps extending from said tube.

4. A tissue acquisition device for retrieving target tissue from a patient'"'"'s body comprising:

a shaft having a distal end configured for entry into the patient'"'"'s body;

a cutting element disposed on the distal end of the shaft configured for cutting target tissue surrounding the shaft; and

a fixation agent disposed on the distal end of the shaft for securing the shaft adjacent target tissue, said fixation agent being configured for penetrating tissue.

5. The tissue acquisition instrument as recited in claim 4, wherein the fixation agent comprises a mechanical fixation agent extendable outwardly into the target tissue.

6. The tissue acquisition instrument as recited in claim 5, wherein said mechanical fixation agent comprises a plurality of radially extendable and retractable wires.

8. The tissue acquisition instrument as recited in claim 4 wherein said instrument comprises a biopsy instrument.

9. The tissue acquisition instrument as recited in claim 4, wherein the cutting element disposed on the distal end of the shaft comprises an electrosurgical cutting element.

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

a) providing a medical device comprising a shaft having a distal end with a distal tip configured for entry into a patient'"'"'s body within target tissue, a radially extendable fixation member which has a free end and which is spaced proximal from the distal tip and a cutting element;

b) placing the distal end of the shaft within the patient'"'"'s body, so that the distal end is disposed within target tissue; and

c) extending into the target tissue the free end of at least one radially extendable fixation member from a side of the shaft so that the distal end of the shaft becomes secured within the target tissue.

11. A method for performing a tissue acquisition procedure using a tissue acquisition device having a shaft with a distal end, a proximal end, a longitudinal axis, and a cutting element, comprising:

a) placing the distal end of the instrument in a patient'"'"'s body, so that the distal end is disposed adjacent the target tissue;

b) securing the distal end of the shaft adjacent the target tissue by extending into the target tissue at least one radially extendable and retractable member from a side of the shaft spaced proximal to the distal end, said member having a free end configured for engaging tissue; and

c) actuating the cutting element to acquire one or more tissue samples of target tissue.

12. The method as recited in claim 11, wherein securing the distal end of the shaft comprises securing the distal end of the shaft effective that the device does not move relative to the target tissue during the tissue acquisition procedure.

13. The method as recited in claim 11, wherein the tissue acquisition procedure is a biopsy procedure.

14. The method as recited in claim 11, wherein the patient is transported from one location to another between steps b) and c).