Methods of high rate, low profile tissue removal

• US 8,951,274 B2
• Filed: 04/29/2009
• Issued: 02/10/2015
• Est. Priority Date: 04/06/2007
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Adams, Ronald David, Chin, Albert Chun-Chi, Sullivan, Roy Hewitt, Litscher, Eric Karl, Churchill, William Lucas, Gruber, William Harwick
• Primary Examiner(s): HOLWERDA, KATHLEEN SONNETT
• Application Number:
  US12/432,691
• Publication Number:
  US 20090270897A1
• Time in Patent Office: 2,113 Days
• Field of Search: 606/177, 606/178, 606 79- 85, 606/159, 606/166, 606/167, 606/15, 606/41, 606119-123, 606169-172, 606/180, 604/22, 600/564, 600/565, 600/567
• US Class Current: 606/171
• CPC Class Codes: A61B 1/303 for the vagina, i.e. vaginoscopes
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 17/320783 through side-hole, e.g. sliding or rotating cutter inside catheter
• CPC Class Codes: A61B 17/3421 Cannulas
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3496 Protecting sleeves or inner probes; Retractable tips for protecting body piercing guide needles A61M25/0612
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• 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 2010/0208 Biopsy devices with actuators, e.g. with triggered spring mechanisms
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/00685 Archimedes screw
• CPC Class Codes: A61B 2017/00738 part of the tool being offset with respect to a main axis, e.g. for better view for the surgeon
• CPC Class Codes: A61B 2017/00973 pedal-operated
• 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 2017/3445 : used as instrument channel for multiple instruments
• CPC Class Codes: A61B 2017/3447 : Linked multiple cannulas
• CPC Class Codes: A61B 2017/3466 : for simultaneous sealing of multiple instruments
• 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: A61B 2217/007 : with irrigation system
• CPC Class Codes: A61B 8/12 : in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61B 90/30 : Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61M 1/842 : rotating continuously rotating surgical cutting instruments A61B17/32002

Abstract

Disclosed are methods and devices for removing tissue from a site in a hollow organ, where the device has a low crossing profile and is capable of removing tissue at a high rate of speed. The device includes an elongate outer tube with a side opening and an inner tube moveably coaxially positioned within the outer tube. Tissue drawn into the side opening can be severed by moving the inner tube across the opening. Tissue may be removed through the device at a rate of at least about 1.4 cc per minute, through a lumen having a cross-sectional area of no greater than about 12.0² mm. Cutting may be accomplished by rotating the inner tube at a speed of at least about 4000 rpm, and axially reciprocating the inner tube at a rate of at least about 1.5 cycles per second. The window may have a rho value of no more than about 1, and the outside diameter of the device may be no more than about 3 mm.

Claims

1. A method of removing tissue from a treatment site in a uterus, comprising the steps of:

accessing the uterus transcervically with an elongate tubular surgical device;

introducing fluid into the uterus;

applying a vacuum to remove fluid from the uterus through a lumen in the tubular surgical device;

severing tissue from the treatment site using the elongate tubular surgical device; and

removing the severed tissue from the treatment site through the lumen in the tubular surgical device at a removal rate of at least about 1.4 grams per minute,

wherein an outside diameter of a portion of the tubular surgical device accessing the uterus is no more than about 3 mm.

2. The method as in claim 1, wherein the tissue is removed at a rate of at least about 1.5 grams per minute.

3. The method as in claim 1, wherein the tissue is removed at a rate of at least about 1.8 grams per minute.

4. The method as in claim 1, wherein the tissue is removed at a rate of at least about 2.0 grams per minute.

5. The method as in claim 1, wherein the tissue comprises uterine fibroid tissue.

6. The method as in claim 1, wherein the tissue is removed at a rate of at least about 2.2 grams per minute.

14. The method as in claim 1, wherein the tubular surgical device accesses the uterus through a lumen of an introducer sheath transcervically positioned in the uterus, a distal portion of the introducer sheath accessing the uterus having an outer diameter of about 5.5 mm.

15. The method as in claim 1, wherein introducing the fluid into the uterus comprises introducing a quantity of fluid that is sufficient to distend the uterus.

7. A method of removing tissue from a treatment site in a uterus, comprising the steps of:

distending the uterus;

transcervically introducing a tissue removal device into the uterus, wherein the tissue removal device comprises an elongate tubular device having an outer tube with a side opening and an inner tube coaxially positioned within the outer tube;

positioning the tissue removal device at the treatment site so that tissue extends into the side opening;

moving the inner tube with respect to the outer tube to sever tissue extending into the side opening; and

applying a vacuum to remove severed tissue through a lumen of the inner tube at a removal rate of at least about 1.5 grams per minute,

wherein the moving step comprises rotating the inner tube, while simultaneously causing the inner tube to oscillate translationally relative to the outer tube with an advance ratio of no more than about 0.25, the advance ratio being a ratio of the speed at which the inner tube oscillates translationally to the speed at which the inner tube rotates.

8. The method of removing tissue as in claim 7, wherein the moving step comprises causing the inner tube to oscillate translationally at a rate of at least about 1.5 cycles per second.

9. The method of removing tissue as in claim 7, wherein the side opening has a rho value of no more than about 1.

10. The method of removing tissue as in claim 9, wherein the advance ratio is no more than about 0.15.

11. The method of removing tissue as in claim 9, wherein the moving step comprises rotating the inner tube at a speed of at least 5000 rotations per minute.

12. The method of removing tissue as in claim 9, wherein the moving step comprises rotating the inner tube at a speed of at least 6000 rotations per minute.

13. The method of removing tissue as in claim 9, wherein the tissue removal device is introduced into the uterus through a lumen of an introducer sheath transcervically positioned in the uterus, a distal portion of the introducer sheath accessing the uterus having an outer diameter of about 5.5 mm.

16. The method of removing tissue as in claim 9, wherein distending the uterus comprises introducing fluid into the uterus.

17. A method of removing tissue from a uterus, comprising:

distending the uterus;

transcervically introducing a tissue removal device into the uterus, the tissue removal device comprising an elongate tubular device having an outer tube with a side opening in a distal portion thereof, and an inner tube coaxially positioned within the outer tube;

positioning a distal portion of the tissue removal device at the treatment site so that tissue extends into the side opening of the outer tube;

moving the inner tube with respect to the outer tube to sever tissue extending into the side opening; and

applying a vacuum to remove severed tissue through a lumen of the inner tube at a removal rate of at least about 1.5 grams per minute,

wherein moving the inner tube with respect to the outer tube comprises rotating the inner tube at a speed of at least 5,000 rotations per minute, while simultaneously causing the inner tube to oscillate translationally relative to the outer tube at about 2.5 to 4 cycles per second.

18. The method of claim 17, wherein the tissue removal device is introduced into the uterus through a lumen of an introducer sheath transcervically positioned in the uterus, a distal portion of the introducer sheath accessing the uterus having an outer diameter of about 5.5 mm.

19. The method of claim 17, wherein the tissue comprises uterine fibroid tissue.

20. The method of claim 17, wherein distending the uterus comprises introducing fluid into the uterus.