SYSTEMS FOR PERFORMING GYNECOLOGICAL PROCEDURES WITH MECHANICAL DISTENSION

• US 20080097470A1
• Filed: 09/07/2007
• Published: 04/24/2008
• Est. Priority Date: 10/18/2006
• Status: Active Grant

• Current Assignee: Hologic Incorporated
• Original Assignee: Hologic Incorporated
• Inventors: Connors, Kevin G., Adams, Ronald D., Gruber, William H., Cole, James Daniel, Pardo, Geoffrey B., Flaherty, J. Christopher
• Granted Patent: US 8,647,349 B2
• Time in Patent Office: Days
• US Class Current: 606/119
• CPC Class Codes: A61B 17/0218 for minimally invasive surgery A61B17/0281, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/32002 with continuously rotating, oscillating or reciprocating cutting instruments
• 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 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 18/1485 having a short rigid shaft for accessing the inner body through natural openings
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61B 2017/00026 Conductivity or impedance, e.g. of tissue
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014
• CPC Class Codes: A61B 2017/320024 Morcellators, e.g. having a hollow cutting tube with an annular cutter for morcellating and removing tissue
• CPC Class Codes: A61B 2017/320028 with reciprocating movements
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 2017/4225 Cervix uteri
• CPC Class Codes: A61B 2017/4233 Operations on Fallopian tubes, e.g. sterilization A61B2017/1125 takes precedence
• CPC Class Codes: A61B 2090/3614 using optical fibre
• CPC Class Codes: A61B 2090/378 using ultrasound
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/02 : Devices for expanding tissue, e.g. skin tissue implements for holding wounds open, surgical tractors A61B17/02; implantable mammary prosthesis A61F2/12; dilators A61M29/00
• CPC Class Codes: A61N 5/1016 : Gynaecological radiation therapy

Abstract

Systems, methods, apparatus and devices for performing improved gynecologic and urologic procedures are disclosed. The system and devices provide simplified use and reduced risk of adverse events. Patient benefit is achieved through improved outcomes, reduced pain, especially peri-procedural pain, and reduced recovery times. The various embodiments enable procedures to be performed outside the hospital setting, such as in a doctor'"'"'s office or clinic. An intrauterine access end procedure system includes a mechanical distension element, to eliminate the need for liquid distension media at pressure sufficient to create a risk of intravasation.

Claims

1. An intrauterine access and procedure system, comprising:

an elongate, tubular sheath having a proximal end, a distal end and at least one lumen extending therethrough, the sheath adapted for transcervical access to the uterus;

a visualization element adapted to extend through the sheath for visualizing a site within the uterus;

a tissue removal element adapted to extend through the sheath for removing tissue from the site; and

a distension element adapted to achieve an equivalent distension to that achieved by introduction of a liquid distension media at a pressure of at least 40 mm Hg.

2. An intrauterine access and procedure system as in claim 1, wherein the outside diameter of the sheath is less than about 9 mm.

3. An intrauterine access and procedure system as in claim 1, wherein the outside diameter of the sheath is less than about 7 mm.

4. An intrauterine access and procedure system as in claim 1, wherein the outside diameter of the sheath is less than about 6 mm.

5. An intrauterine access and procedure system as in claim 1, wherein the visualization element comprises a lens.

6. An intrauterine access and procedure system as in claim 1, wherein the visualization element comprises an ultrasound transducer.

7. An intrauterine access and procedure system as in claim 1, wherein the sheath comprises at least one radiopaque marker.

8. An intrauterine access and procedure system as in claim 1, wherein the tissue removal element comprises a tissue cutter.

9. An intrauterine access and procedure system as in claim 1, wherein the tissue cutter comprises an oscillating cutter.

10. An intrauterine access and procedure system as in claim 1, wherein the tissue cutter comprises a rotating cutter.

11. An intrauterine access and procedure system as in claim 1, wherein the tissue removal element comprises an acoustic generator.

12. An intrauterine access and procedure system as in claim 1, wherein the tissue removal element comprises a tissue morcellator.

13. An intrauterine access and procedure system as in claim 1, wherein the tissue removal element comprises an ablation element.

14. An intrauterine access and procedure system as in claim 1, further comprising a pull wire for deflecting the distal end of the sheath.

15. An intrauterine access and procedure system as in claim 1, further comprising an inflatable balloon carried by the sheath.

16. An intrauterine access and procedure system as in claim 1, further comprising a tissue penetrating assembly.

17. An intrauterine access and procedure system as in claim 1, further comprising a stabilization device.

18. An intrauterine access and procedure system as in claim 1, further comprising a drug delivery assembly.

19. An intrauterine access and procedure system as in claim 1, wherein the distension element comprises an expandable basket.

20. An intrauterine access and procedure system as in claim 1, further comprising a volume occupying device.