Electrosurgical biopsy device and method

• US 6,261,241 B1
• Filed: 09/23/1998
• Issued: 07/17/2001
• 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): O'Connor, Cary
• Assistant Examiner(s): MARMOR II, CHARLES ALAN
• Application Number:
  US09/159,467
• Time in Patent Office: 1,028 Days
• Field of Search: 600/373, 600/393, 600/562, 600/564, 600/567, 600/568, 606/37, 606/39, 606/41, 606/45, 606/167, 606/170, 606/46, 606/47, 606/48, 606/49, 606/50, 606/51, 606/52, 604/22, 604/114, 607/115, 607/116
• 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 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 18/14 Probes or electrodes therefor
• 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 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• 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 2018/00898 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 2018/1475 : 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 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

Abstract

An electrosurgical biopsy device includes a stylet and a cannula movably mounted on a base. The stylet has a shaft with a head at its distal end and a stylet ablation element extending distally from the head. The stylet shaft is disposed through the cannula for axial translation therein between withdrawn and extended positions. The cannula has an opening at its distal end and a cannula ablation element adjacent the opening. Both ablation elements are activatable with energy that ablates adjacent tissue. A translation mechanism controllably moves (a) the stylet between the withdrawn and extended positions and (b) the cannula between a proximal position and a distal position relative to the base. In use, with the stylet in the withdrawn position against the distal end of the cannula, and with the stylet ablation element activated, the stylet and the cannula are pushed through the skin and the underlying tissue until the stylet head is adjacent a targeted tissue mass. Next, the stylet is extended distally from the distal end of the cannula so that its head penetrates the tissue mass. The cannula ablation element is then activated, and the cannula is pushed through the tissue mass toward the stylet head, thereby cutting a “core” through the tissue mass that is captured as a tissue specimen within the distal end of the cannula. The cannula and the stylet are then removed from the patient'"'"'s body.

Claims

1. A biopsy device, comprising:

an elongate cannula having an open distal end and a proximal end;

a first tissue ablation element disposed on the open distal end of the cannula;

an elongate stylet slidably disposed within the cannula configured for axial translation between an extended position and a withdrawn position; and

a second tissue ablation element disposed on a distal end of the stylet.

2. The biopsy device of claim 1, wherein the stylet comprises:

a shaft having a proximal end and a distal end; and

a substantially hemispherical stylet head disposed on the distal end of the shaft, the second tissue ablation element extending over a distal end surface of the stylet head.

3. The biopsy device of claim 2, wherein the first and second tissue ablation elements are activated by radio frequency electrical current.

4. The biopsy device of claim 3, wherein the second ablation element comprises an arcuate length of electrical conductor having a radius of curvature that is substantially coplanar with a longitudinal axis of the shaft.

5. The biopsy device of claim 1, wherein the stylet comprises:

a shaft having a proximal end and a distal end; and

a conical head terminating in an apex portion, wherein the second tissue ablation element includes the apex portion.

6. The biopsy device of claim 1, further comprising a stylet translation mechanism coupled to the stylet for translating the stylet within the cannula between the withdrawn and extended positions.

7. The biopsy device of claim 6, wherein the biopsy device includes a base, wherein the stylet has a proximal end extending proximally from the proximal end of the cannula, and wherein the translation mechanism comprises:

a carrier connected to the proximal end of the stylet and movably mounted on the base, the carrier being movable on the base between a first position in which the stylet is in the withdrawn position and a second position in which the stylet is in the extended position; and

a carrier drive, coupled to the carrier, for moving the carrier between the first and second positions.

8. The biopsy device of claim 7, wherein the carrier drive is driven by a motor.

9. The biopsy device of claim 8, wherein the motor has a drive shaft, and wherein the carrier drive comprises:

a drive screw coupled for rotation with the drive shaft;

a screw-driven mechanism coupled between the drive screw and the carrier, whereby rotation of the drive screw in a first direction moves the carrier from the first position to the second position.

10. An electrosurgical stylet, comprising:

a shaft having a proximal end and a distal end;

a stylet head disposed on the distal end of the shaft; and

a tissue ablation electrode formed of an arcuate length of electrical conductor which extends over a distal end surface of the stylet head spaced distally from the distal end surface.

11. The electrosurgical stylet of claim 10, wherein the stylet head has a substantially hemispherical distal end surface.

12. The electrosurgical stylet of claim 10, wherein the tissue ablation electrode comprises an arcuate length of electrical conductor having a radius of curvature that is substantially coplanar with a longitudinal axis of the shaft.

13. The electrosurgical stylet of claim 10, wherein the tissue ablation electrode is formed from a length of electrical conductor which protrudes from diametrically opposed sides of the stylet head and extends over the distal end surface of the stylet head spaced distally from the distal end surface.

14. A biopsy device, comprising:

a base having a proximal end and a distal end;

an elongate cannula having an open distal end and an open proximal end mounted on the base for axial translation thereon between a proximal position and a distal position;

an elongate stylet slidably disposed within the cannula, the stylet having a proximal end that extends proximally from the proximal end of the cannula and that is mounted on the base for axial translation between a withdrawn position and an extended position with respect to the cannula;

a first tissue ablation element disposed on the open distal end of the cannula;

a second tissue ablation element disposed on a distal end of the stylet; and

a translation mechanism for sequentially moving the stylet from its withdrawn position to its extended position, and then moving the cannula from its proximal position to its distal position.

15. The biopsy device of claim 14, wherein the translation mechanism comprises:

a first carrier, connected to the proximal end of the stylet and slidably mounted on the base for translation thereon between a first position corresponding to the withdrawn position of the stylet and a second position corresponding to the extended position of the stylet;

a second carrier, connected to the proximal end of the cannula and slidably mounted on the base between the first carrier and the distal end of the base, for translation thereon between a proximal position corresponding to the proximal position of the cannula and a distal position corresponding to the distal position of the cannula; and

a carrier drive engageable with the first and second carriers, for sequentially driving the first carrier from its first position to its second position and then driving the second carrier from its proximal position to its distal position.

16. The biopsy device of claim 15, wherein the carrier drive comprises:

a motor having a drive shaft;

a drive screw coupled for rotation with the drive shaft;

a screw driven mechanism coupled between the drive screw and the first carrier, whereby rotation of the drive screw in a first direction moves the first carrier from the first position to the second position.

17. The biopsy device of claim 15, wherein the stylet is removably mounted in the first carrier and the cannula is removably mounted in the second carrier.

18. The biopsy device of claim 14, wherein the first and second tissue ablation elements are activated by radio frequency electrical current.

19. The biopsy device of claim 18, wherein the first ablation element is an ablation electrode, and wherein the cannula includes a return electrode spaced from the ablation electrode.

20. The biopsy device of claim 19, wherein the cannula includes an elongate aperture along a portion of its length, and wherein the return electrode comprises a length of conductor contained within the cannula, at least a portion of the conductor being exposed through the elongate aperture.

21. The biopsy device of claim 14, wherein the stylet comprises:

a shaft having a proximal end and a distal end and defining a longitudinal axis therebetween; and

a substantially hemispherical stylet head disposed on the distal end of the shaft with the second tissue ablation element extending distally from the head.

22. The biopsy device of claim 21, wherein the first and second ablation elements are energized by radio frequency electrical current, and wherein the second ablation element comprises an arcuate length of electrical conductor having a radius of curvature that is substantially coplanar with the longitudinal axis of the shaft.

23. A method of taking a tissue sample from a targeted subcutaneous tissue mass within the body of a patient, comprising:

a) providing a probe comprising;

a cannula having an open distal end,

a stylet disposed within the probe for axial movement therein between a withdrawn position and an extended position relative to the distal end of the cannula,

a first tissue ablation element disposed on the open distal end of the cannula, and

a second tissue ablation element disposed on a distal end of the stylet;

b) while activating the second ablation element with energy of a type and quantity that causes tissue ablation, advancing the probe by tissue ablation, with the stylet in the withdrawn position, into the patient'"'"'s body toward the targeted tissue mass;

c) with the second ablation element activated, moving the stylet to its extended position so that it penetrates the targeted tissue mass by ablation, while creating a gap between the second ablation element and the distal end of the cannula that fills with a portion of the tissue from the targeted tissue mass;

d) while activating the first ablation element with energy of a type and quantity that causes tissue ablation, moving the cannula distally relative to the stylet so as to close the gap, thereby capturing the portion of the tissue mass within the cannula; and

e) withdrawing the probe from the body with the portion of the tissue mass captured within the cannula.

24. The method of claim 23, wherein the first and second ablation elements are activated with radio frequency electrical current.

25. The method of claim 23, wherein the stylet and the cannula are movably mounted on a base, wherein the cannula is movable between a proximal position and a distal position relative to the base, wherein the cannula is in the proximal position during advancing the probe and of moving the stylet, and wherein moving the cannula includes moving the cannula from its proximal position to its distal position.

26. The method of claim 23, wherein moving the stylet and moving the cannula are performed by an electrically powered driving mechanism.

27. The method of claim 23, wherein moving the stylet creates a narrow slice through the targeted tissue mass.

28. An elongated device for accessing a tissue site within a patient, comprising:

a. an elongated shaft which has proximal and distal ends;

b. a thin, tissue cutting electrode which is secured to the distal end of the shaft and which has an activatable arcuate portion spaced distally from the distal end of the shaft; and

c. an elongated electrical conductor which has one end electrically connected to the thin, tissue cutting electrode secured to the distal end of the elongated shaft and one end configured to be electrically connected to a high frequency electrical power source.

29. The elongated accessing device of claim 28 wherein the thin, tissue cutting electrode secured to the distal end of the elongated shaft is formed of conductive metallic material.

30. The elongated accessing device of claim 28 wherein the elongated shaft is provided with an arcuate cutting member at a location spaced proximally from the distal end of the elongated shaft.

31. The elongated accessing device of claim 30 wherein the arcuate proximal cutting member is an electrode.

32. The elongated accessing device of claim 30 wherein an electrical conductor is provided having one end electrically connected to the arcuate cutting member and open end configured to be electrically connected to a high frequency electrical power source.

33. The elongated accessing device of claim 30 wherein the arcuate cutting member is rotatable about a longitudinal axis of the elongated shaft.

34. The elongated accessing device of claim 28, wherein the distal end of the elongated shaft has a substantially hemispherical surface.

35. The accessing device of claim 28, further comprising a translation mechanism coupled to the elongated shaft for translating the accessing device between the withdrawn and extended positions.

36. The accessing device of claim 28, wherein the tissue cutting electrode comprises an arcuate length of electrical conductor having a radius of curvature that is substantially coplanar with a longitudinal axis of the shaft.

37. The accessing device of claim 28, wherein the tissue cutting electrode is formed from a length of electrical conductor which protrudes from diametrically opposed sides of the distal end of the elongated shaft and extends over the surface of the distal end.