Method, system and device for tissue removal

• US 8,574,253 B2
• Filed: 04/04/2008
• Issued: 11/05/2013
• Est. Priority Date: 04/06/2007
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Gruber, William Harwick, Adams, Ronald David, Chin, Albert Chun-Chi, Litscher, Eric Karl, Sullivan, Roy Hewitt, DiCesare, Paul, Radziunas, Jeffrey, Vigliotti, Daniel, Knodel, Bryan Dale, Daniels, Chris Scott, Vititoe, Kevin J., Lorenz, Michael Anthony, Kolada, Paul P., Crisp, Ryan Scott, Cicenas, Chris William, Mora, Ludwin M., Burchfield, Brent Lee
• Primary Examiner(s): Hughes, S. Thomas
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US12/098,250
• Publication Number:
  US 20080249553A1
• Time in Patent Office: 2,041 Days
• Field of Search: 606/170, 606/171, 606 79- 85, 606/159, 606/166, 606/167, 606/169, 606/177, 606/178, 606110-115, 606/127, 606/128, 604/22, 600/564, 600/565, 600/567
• US Class Current: 606/171
• CPC Class Codes: A61B 17/29 Forceps for use in minimally invasive surgery
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• CPC Class Codes: A61B 17/3201 Scissors for biopsy A61B10/02
• CPC Class Codes: A61B 17/32053 Punch like cutting instruments, e.g. using a cylindrical or oval knife A61B17/326 takes precedence; trepans A61B17/1695; for use on the cornea A61F9/007
• 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 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/42 Gynaecological or obstetrical instruments or methods ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708; dilators A61M29/00
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/2905 flexible
• CPC Class Codes: A61B 2017/320004 abrasive
• CPC Class Codes: A61B 2017/320028 with reciprocating movements
• CPC Class Codes: A61B 2017/320064 with tissue or sample retaining means
• CPC Class Codes: A61B 2017/320775 Morcellators, impeller or propeller like means
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2018/1407 Loop
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 1/842 rotating continuously rotating surgical cutting instruments A61B17/32002

Abstract

A method and device for tissue removal. The device may be used to remove uterine fibroids and other abnormal gynecological tissue. According to one embodiment, the device includes a housing, an outer tube, and an inner tube. The outer tube is fixed to the housing and includes a side window proximate to its distal end. The side window may have sloped proximal and distal ends. The inner tube has a distal end positioned within the outer tube, the distal end being adapted to rotate and, at the same time, to move back and forth past the side window, with the rotational and translational movement of the inner tube being independently controllable. The distal end of the inner tube may have an external bevel. Suction is applied to the proximal end of the inner tube to draw tissue into the side window and to remove resected tissue through the inner tube.

Claims

1. A uterine fibroid tissue removal device, comprising:

an elongate outer tubular member having an outside diameter of no more than about 3.5 mm, the outer tubular member including a tissue receiving side window configured to receive uterine fibroid tissue to be severed from a uterus wall;

an inner tubular member positioned within the outer tubular member, the inner tubular member comprising a proximal end, an open distal end, and a tissue aspiration lumen extending therebetween;

a translational drive configured to oscillate the inner tubular member translationally along a longitudinal axis of the inner tubular member, such that the open distal end of the inner tubular member oscillates translationally across the tissue receiving side window of the outer tubular member to thereby sever uterine fibroid tissue extending therethrough; and

a rotational drive that rotates the inner tubular member at a rate of at least 5000 revolutions per minute about the longitudinal axis of the inner tubular member while the inner tubular member oscillates translationally across the tissue receiving side window, such that the device is capable of removing uterine fibroid tissue severed by the inner tubular member at a rate of at least about 1.8 gm/min.

2. The tissue removal device of claim 1, wherein

the rotational drive comprises a rotational driving mechanism mechanically coupling a first drive shaft to the inner tubular member to transfer rotational energy from the first drive shaft to the inner tubular member to thereby rotate the inner tubular member about the longitudinal axis of the inner tubular member;

and wherein

the translational drive comprises an oscillating translational driving mechanism mechanically coupling a second drive shaft to the inner tubular member to transfer translating energy from the second drive shaft to the inner tubular member to thereby oscillate translationally the inner tubular member along the longitudinal axis of the inner tubular member.

3. The tissue removal device of claim 1, further comprising a vacuum source in communication with the tissue aspiration lumen of the inner tubular member.

4. The tissue removal device of claim 1, wherein at least a portion of the outer tubular member is flexible.

5. The tissue removal device of claim 4, wherein at least a portion of the inner tubular member is flexible.

6. The tissue removal device of claim 1, further comprising a housing coupled to the outer tubular member.

7. The tissue removal device of claim 6, wherein the outer tubular member is coupled to the housing in a non-coaxial manner.

8. The tissue removal device of claim 1, wherein the rotational drive rotates the inner tubular member at a rate of approximately 6000 revolutions per minute, and the translational drive is configured to translationally oscillate the inner tubular member at a rate of approximately 240 cycles per minute.

9. The tissue removal device of claim 8, wherein an advance ratio equal to a ratio of the rate of oscillation to the rate of rotation of the inner tubular member is less than 0.25.

10. The tissue removal device of claim 1, wherein the open distal end of the inner tubular member has an external bevel.

11. The tissue removal device of claim 1, wherein the tissue receiving side window on the outer tubular member has sloped or jagged distal and proximal ends.