METHODS, SYSTEMS AND DEVICES FOR PERFORMING GYNECOLOGICAL PROCEDURES

• US 20080135053A1
• Filed: 11/06/2007
• Published: 06/12/2008
• Est. Priority Date: 11/07/2006
• Status: Active Grant

• Current Assignee: Gen-Probe Incorporated (Hologic Incorporated)
• Original Assignee: Hologic Incorporated
• Inventors: Flaherty, J. Chirstopher, GRUBER, WILLIAM HARWICK, Adams, Ronald David
• Granted Patent: US 8,025,656 B2
• Time in Patent Office: Days
• US Class Current: 128/831
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 17/12131 characterised by the type of occluding device
• CPC Class Codes: A61B 17/12159 Solid plugs; being solid before insertion
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/00986 Malecots, e.g. slotted tubes, of which the distal end is pulled to deflect side struts
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61F 6/208 Implements for ligaturing
• CPC Class Codes: A61F 6/225 transcervical

Abstract

Methods, systems and devices for performing gynecological procedures. According to one embodiment, there is provided a device for occluding a fallopian tube, the device including an outer member and an inner member. The outer member may be a hollow, frusto-conical structure shaped to include an open proximal end, an open distal end, and a side wall. The outer member may be self-expandable such that the distal end is biased radially outwardly. In addition, the side wall may have a porous structure to permit the ingrowth of tissue therethrough. Tines may be provided on the outer surface of the side wall to promote the anchoring of the outer member in a fallopian tube. The inner member, which may be structured to induce scarring, may comprise an elongated fibrous body fixed at its proximal end to the proximal end of the outer member. A bore may extend distally from the proximal end of the inner member to receive a delivery rod. The inner member, which may have pores or interstices to permit the ingrowth of tissue thereinto, is coated or impregnated with a sclerosing agent.

Claims

1. A device for use in occluding a fallopian tube, the device comprising:

a) a self-expandable structure, the self-expandable structure being insertable into the fallopian tube and, once expanded, being engageable with the inner wall of the fallopian tube; and

b) a sclerosing agent, the sclerosing agent being delivered to the fallopian tube by the self-expandable structure.

2. The device as claimed in claim 1 wherein the self-expandable structure comprises a frusto-conical member.

3. The device as claimed in claim 2 wherein the frusto-conical member is shaped to include an open proximal end, an open distal end and a side wall, the open distal end being outwardly biasing, the side wall being porous to permit the ingrowth of tissue therethrough.

4. The device as claimed in claim 3 wherein the device further comprises a scar-inducing structure, the scar-inducing structure being fixed within the frusto-conical member and bearing the sclerosing agent.

5. The device as claimed in claim 4 wherein the scar-inducing structure comprises a fibrous polyester member.

6. The device as claimed in claim 4 wherein the sclerosing agent is coated on the surface of the scar-inducing structure.

7. The device as claimed in claim 4 wherein the scar-inducing structure is impregnated with the sclerosing agent.

8. The device as claimed in claim 1 wherein the sclerosing agent is selected from the group consisting of quinacrine, talc, and doxycycline.

9. The device as claimed in claim 4 wherein the scar-inducing structure has an open distal end for receiving an insertion rod.

10. The device as claimed in claim 3 wherein the side wall is shaped to include at least one anchoring member.

11. The device as claimed in claim 1 wherein the self-expandable structure comprises at least one malecot structure.

12. The device as claimed in claim 11 wherein the self-expandable structure comprises a plurality of malecot structures.

13. The device as claimed in claim 1 wherein the self-expandable structure comprises a Z-shaped stent.

14. The device as claimed in claim 1 wherein the self-expandable structure comprises a spider filter.

15. The device as claimed in claim 1 wherein the self-expandable structure comprises a wall-stent that has been twisted in opposite directions at its two ends and then heat-set in the twisted state.

16. A system for use in occluding a fallopian tube, the system comprising:

a) the device as claimed in claim 1;

b) a protective delivery sheath, the device being slidably disposed within the protective delivery sheath; and

c) means for translationally positioning the device relative to the protective delivery sheath.

17. The system as claimed in claim 16 wherein said positioning means is detachably engageable with the device.

18. A device for use in occluding a fallopian tube, the device comprising:

a) a tubular member, the tubular member comprising a proximal end, a distal end and a longitudinal bore;

b) an elongated member, the elongated member comprising a proximal end, a distal end, a bore extending distally from the proximal end, and a port located intermediate to the proximal end and the distal end, the port being in fluid communication with the bore, the distal end being enlarged, the proximal end of the elongated member being slidable within the longitudinal bore of the tubular member.

19. The device as claimed in claim 18 wherein the distal end bears a sclerosing agent.

20. The device as claimed in claim 18 further comprising means for providing suction to the bore of the elongated member.

21. The device as claimed in claim 18 further comprising means for impeding the elongated member from sliding distally relative to the tubular member.

22. A device for occluding a tube, the device comprising:

a) a tubular member, the tubular member comprising a proximal end, a distal end and a longitudinal bore;

b) a balloon, the balloon being reversibly inflatable and being slidably disposed within the longitudinal bore of the tubular member;

c) a ligating band, the ligating band being mounted around the tubular member; and

d) means for ejecting the ligating band distally from the tubular member.

23. A method for accessing the peritoneal cavity of a patient, the method comprising the steps of:

a) inserting the distal end of a guidewire through the vagina, the cervix, the uterus, and a fallopian tube and into the peritoneal cavity; and

b) inserting the distal end of a scope distally over the guidewire until the distal end of the scope is positioned in the peritoneal cavity.

24. A method for performing a gynecological procedure in the peritoneal cavity of a patient, the method comprising the steps of:

a) inserting the distal end of a guidewire through the vagina, the cervix, the uterus, and a fallopian tube and into the peritoneal cavity;

b) inserting the distal end of a scope distally over the guidewire until the distal end of the scope is positioned in the peritoneal cavity;

c) removing the guidewire from the patient and from the scope, thereby leaving the guidewire lumen unoccupied;

d) delivering a tool to the peritoneal cavity through the unoccupied lumen of the scope, the tool having at least one of a diagnostic utility and a therapeutic utility; and

e) using the tool to perform at least one of a diagnostic procedure and a therapeutic procedure in the peritoneal cavity.

25. A method for performing a gynecological procedure in the peritoneal cavity of a patient, the method comprising the steps of:

a) inserting the distal end of a guidewire through the vagina, the cervix, the uterus, and a fallopian tube and into the peritoneal cavity;

b) inserting the distal end of a scope distally over the guidewire until the distal end of the scope is positioned in the peritoneal cavity;

c) inserting the distal end of the guidewire through one of the uterus and the fomix;

d) withdrawing the distal end of the guidewire from the patient through the vagina;

e) delivering a tool to the peritoneal cavity by passing the tool over one of the proximal end of the guidewire and the distal end of the guidewire until the tool is positioned in the peritoneal cavity, the tool having at least one of a diagnostic utility and a therapeutic utility; and

f) using the tool to perform at least one of a diagnostic procedure and a therapeutic procedure.