Core sampling biopsy device with short coupled MRI-compatible driver

• US 7,611,474 B2
• Filed: 12/29/2004
• Issued: 11/03/2009
• Est. Priority Date: 12/29/2004
• Status: Active Grant

• Current Assignee: Devicor Medical Products Incorporated (Danaher Corporation)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Hibner, John A., Navin, Eric R., Contini, Vincent J., Bullen, Lawrence, Predmore, Kevin D., Dvorsky, James E.
• Primary Examiner(s): Hindenburg; Max
• Assistant Examiner(s): Foreman; Jonathan M.
• Application Number:
  US11/025,556
• Publication Number:
  US 20060149163A1
• Time in Patent Office: 1,770 Days
• Field of Search: 600/562, 600564-568, 606/167, 606/171, 606/180
• US Class Current: 600/566
• CPC Class Codes: A61B 10/0266 means for severing sample
• 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 2017/00535 pneumatically or hydraulically operated A61B2017/22051, A61B2090/401 take precedence
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00544 pneumatically

Abstract

A core sampling biopsy device is compatible with use in a Magnetic Resonance Imaging (MRI) environment by being driven by either a pneumatic rotary motor or a piezoelectric drive motor. The core sampling biopsy device obtains a tissue sample, such as a breast tissue biopsy sample, for diagnostic or therapeutic purposes. The biopsy device may include an outer cannula having a distal piercing tip, a cutter lumen, a side tissue port communicating with the cutter lumen, and at least one fluid passageway disposed distally of the side tissue port. The inner cutter may be advanced in the cutter lumen past the side tissue port to sever a tissue sample. A cutter drive assembly maintains a fixed gear ratio relationship between a cutter rotation speed and translation speed of the inner cutter regardless of the density of the tissue encountered to yield consistent sample size.

Claims

1. A biopsy device, comprising:

a. an outer piercing tube having an aperture proximate to a distal end thereof for receiving prolapsed tissue, wherein the outer piercing tube has a sharpened closed tip configured to penetrate a patient'"'"'s skin;

b. a cutter tube longitudinally translatable within the piercing tube;

c. a cutter drive assembly comprising;

(i) a translation drive shaft operable to translate the cutter tube,

(ii) a rotation drive shaft operable to rotate the cutter tube, and

(iii) a single-input to dual-output gearbox assembly coupled with the translation drive shaft and the rotation drive shaft, wherein the single-input to dual-output gearbox assembly comprises a translation gear coupled with the translation drive shaft, a rotation gear coupled with the rotation drive shaft, and a common input gear coupled with both the translation gear and the rotation gear, wherein the gearbox assembly is configured to rotate the translation gear and the rotation gear simultaneously in response to rotation of the common input gear;

wherein the cutter drive assembly is operatively configured to;

(v) distally translate the cutter tube at a rate of translation and rotate the cutter tube at a rate of rotation, wherein the rate of translation is in constant proportion to the rate of rotation,

(vi) rotate the cutter tube through a predetermined number of rotations of the cutter tube across the aperture severing received prolapsed tissue,

(vii) maintain the predetermined number of rotations despite axial resistance encountered by the cutter tube from tissues of varying density, and

(viii) translate the cutter tube at a variable rate, wherein the predetermined number of rotations remains constant despite variations in the cutter tube rate of translation; and

d. a rotary motor coupled to the common input gear, such that the rotary motor is operable to rotate the common input gear of the cutter drive assembly.

2. The biopsy device of claim 1, wherein the rotary motor comprises a hydraulic rotary motor.

3. The biopsy device of claim 2, wherein the hydraulic rotary motor comprises a pneumatic rotary motor.

4. The biopsy device of claim 1, further comprising a vacuum assist assembly selectively communicated to the cutter tube to effect prolapse of tissue.

5. The biopsy device of claim 4, further comprising a vacuum lumen communicating between a distal end of the cutter tube and the vacuum assist assembly.

6. The biopsy device of claim 1, wherein the rotary motor comprises a piezoelectric rotary motor.

7. The biopsy device of claim 6, further comprising a flexible drive shaft coupling the piezoelectric rotary motor to the cutter drive assembly.

8. The biopsy device of claim 1, wherein the rotary motor coupled to the common input gear of the cutter drive assembly comprises a nonferrous rotary motor.

9. A biopsy device, comprising:

a. a piercing tube having an aperture proximate to a distal end thereof for receiving prolapsed tissue;

b. a cutter tube longitudinally translatable within the piercing tube;

c. a cutter drive assembly comprising;

(i) a first rotatable drive shaft configured to cause the cutter tube to translate, wherein the first rotatable drive shaft is coupled with a first gear,

(ii) a second rotatable drive shaft configured to cause the cutter tube to rotate, wherein the second rotatable drive shaft is coupled with a second gear, and

(iii) a common input gear, wherein the first gear and the second gear are coupled with the common input gear,

wherein the cutter drive assembly is operatively configured to;

(iv) distally translate the cutter tube at a rate of translation and rotate the cutter tube at a rate of rotation, wherein the rate of translation is in constant proportion to the rate of rotation,

(v) rotate the cutter tube through a predetermined number of rotations of the cutter tube across the aperture to sever prolapsed tissue,

(vi) maintain the predetermined number of rotations despite axial resistance encountered by the cutter tube from tissues of varying density,

(vii) translate the cutter tube at a variable rate; and

d. a rotary motor coupled with the common input gear of the cutter drive assembly.

10. The biopsy device of claim 9, further comprising a vacuum assist assembly selectively communicated to the cutter tube to effect prolapse of tissue.

11. The biopsy device of claim 10, further comprising a vacuum lumen communicating between a distal end of the cutter tube and the vacuum assist assembly.

12. The biopsy device of claim 9, wherein the cutter drive assembly further comprises a single-input to dual-output gearbox housing the first gear, the second gear, and the common input gear.

13. A biopsy device, comprising:

a. a piercing tube having an aperture proximate to a distal end thereof for receiving prolapsed tissue;

b. a cutter tube longitudinally translatable within the piercing tube;

c. a cutter drive assembly comprising;

(i) a threaded drive member operable to translate the cutter tube, wherein the threaded drive member comprises a first thread region having a non-zero pitch, wherein the threaded drive member further comprises a distal thread region having a zero pitch, wherein the zero pitch of the distal thread region permits the cutter tube to rotate through at least one full revolution without translating,

(ii) a rotational drive member operable to rotate the cutter tube,

(iii) a rotary motor, and

(iv) a single-input to dual-output gearbox assembly coupling the rotary motor with the threaded drive member and the rotational drive member, wherein the gearbox assembly comprises;

(A) a translation gear coupled with the threaded drive member,

(B) a rotation gear coupled with the rotational drive member,

(C) a common input gear, wherein the translation gear and rotation gear are coupled with the common input gear, wherein the common input gear is in further communication with the rotary motor,

wherein the cutter drive assembly is operably configured to;

(v) distally translate the cutter tube at a rate of translation and rotate the cutter tube at a rate of rotation, wherein the rate of translation is in constant proportion to the rate of rotation, and

(vi) rotate the cutter tube through a predetermined number of rotations of the cutter tube across the aperture severing prolapsed tissue.

14. The biopsy device of claim 13, further comprising a vacuum assist assembly selectively communicated to the cutter tube to effect prolapse of tissue.

15. The biopsy device of claim 14, further comprising a vacuum lumen communicating between a distal end of the cutter tube and the vacuum assist assembly.

16. The biopsy device of claim 14, further comprising a flexible drive shaft coupling the rotary motor to the common input gear.