Transcervical uterine access and sealing device

• US 5,540,658 A
• Filed: 06/27/1994
• Issued: 07/30/1996
• Est. Priority Date: 06/27/1994
• Status: Expired due to Term

• Current Assignee: Tyco Healthcare Group LP (Medtronic Plc)
• Original Assignee: InnerDyne, Inc. (Medtronic Plc)
• Inventors: Lao, Hen, Evans, Michael A., Dubrul, William R.
• Primary Examiner(s): MCDERMOTT, CORRINE MARIE
• Application Number:
  US08/266,036
• Time in Patent Office: 764 Days
• Field of Search: 604/49, 604/54, 604/55, 604/96, 604/101, 604/104-107, 604/271
• US Class Current: 604/101.04
• 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 18/00 Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body eye surgery A61F9/007; ear surgery A61F11/00
• CPC Class Codes: A61B 2017/3486 Balloon
• CPC Class Codes: A61B 2017/3492 against the outside of the body
• CPC Class Codes: A61B 2018/00101 low, i.e. thermally insulating
• CPC Class Codes: A61B 2018/00166 Multiple lumina

Abstract

A cervical access device includes a tubular body having a proximal end, a distal end, and a lumen extending therebetween. A first expansible occlusion member is disposed near the distal end of the tubular body, and a second occlusion member is proximally spaced apart from the first occlusion member. Together, the first and second occlusion members define a reduced diameter neck for receiving the cervical os. In an exemplary aspect, the first occlusion member includes an evertible cylindrical surface which assumes a conical configuration which diverges in the distal direction when actually compressed. The second occlusion member can also be provided with a conical configuration which diverges in the proximal direction so that the first and second occlusion members when brought together define a neck having opposed tapered walls. A catheter for providing thermal treatment to the uterus can be introduced through the cervical access device to perform thermal treatment on the uterus. The cervical access device provides a seal with the cervical os to help prevent heated thermally conductive medium introduced by the catheter from leaking around the cervical access device outwardly into the vagina.

Claims

1. A transcervical uterine access device comprising:

a tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body;

a second occlusion member proximally spaced-apart from the first occlusion member and sized to be received in the vagina and against the external os of the cervix, the second occlusion member being axially translatable relative to the first occlusion member, wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os; and

wherein the first occlusion member is expansible from a collapsed configuration closely conforming to the exterior surface of the tubular body to a conical configuration which diverges in the distal direction, and wherein the second occlusion member has a conical configuration which diverges in the proximal direction so that the first and second occlusion members when brought together define a neck having opposed tapered walls.

2. A transcervical uterine access device as in claim 1, wherein the tubular body has a length in the range from 15 cm to 30 cm and an outside diameter in the range from 5 mm to 10 mm.

3. A transcervical uterine access device as in claim 1, wherein the first occlusion member comprises an evertible cylindrical surface connected to the distal end of the tubular body which assumes a conical configuration which diverges in the radial direction upon axial translation of the tubular body which axially compresses and radially expands the evertible cylindrical surface.

4. A transcervical uterine access device as in claim 3, further comprising a tubular shaft having a proximal end, a distal end, and a lumen extending therebetween, wherein the tubular shaft is slidably disposed within the lumen of the tubular body with the distal end of the tubular shaft attached to a distal end of the evertible cylindrical surface, wherein the distal end of the tubular body is attached to a proximal end of the evertible cylindrical surface, wherein distal translation of the body relative to the shaft will axially compress and radially expand the evertible cylindrical surface.

5. A transcervical uterine access device as in claim 4, wherein the tubular shaft is constructed of a thermally insulative material.

6. A transcervical uterine access device as in claim 4, further comprising an insulative material within the lumen of the tubular shaft.

7. A transcervical uterine access device as in claim 6, wherein the insulative material includes an extruded polymer having voids.

8. A transcervical uterine access device as in claim 6, wherein the insulative material is constructed of urethane.

9. A transcervical uterine access device as in claim 1, wherein the first occlusion member radially extends from the tubular body to a diameter in the range from about 10 mm to 25 mm.

10. A transcervical uterine access device as in claim 1, wherein the first occlusion member radially extends from the tubular body to a diameter in the range from about 10 mm to 15 mm.

11. A transcervical uterine access device comprising:

a tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body;

a second occlusion member proximally spaced-apart from the first occlusion member and sized to be received in the vagina and against the external os of the cervix, the second occlusion member being axially translatable relative to the first occlusion member, wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os, wherein the first occlusion member comprises an evertible cylindrical surface connected to the distal end of the tubular body which assumes a conical configuration which diverges in the radial direction upon axial translation of the tubular body which axially compresses and radially expands the evertible cylindrical surface;

a tubular shaft having a proximal end, a distal end, and a lumen extending therebetween, wherein the tubular shaft is slidably disposed within the lumen of the tubular body with the distal end of the tubular shaft attached to a distal end of the evertible cylindrical surface, wherein the distal end of the tubular body is attached to a proximal end of the evertible cylindrical surface, wherein distal translation of the body relative to the shaft will axially compress and radially expand the evertible cylindrical surface; and

an insulative material within the lumen of the tubular shaft.

12. A transcervical uterine access device as in claim 11, wherein the insulative material includes an extruded polymer having voids.

13. A transcervical uterine access device as in claim 11, wherein the insulative material is constructed of urethane.

14. A transcervical uterine access device as in claim 11, further comprising a handle assembly which is removable from the body and the shaft, and wherein the handle includes a first lever, means for coupling the first lever to the tubular shaft, a second lever, and means for coupling the second lever to the tubular body, wherein manual actuation of the levers expands the first occlusion member.

15. A transcervical uterine access device comprising:

a tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body;

a second occlusion member proximally spaced-apart from the first occlusion member and sized to be received in the vagina and against the external os of the cervix, the second occlusion member being axially translatable relative to the first occlusion member, wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os; and

wherein the first occlusion member comprises an evertible surface constructed of an elastomeric sheet covering a mesh.

16. A transcervical uterine access device as in claim 15, wherein the tubular body is insulated.

17. A transcervical uterine access device comprising:

a tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body;

a second occlusion member proximally spaced-apart from the first occlusion member and sized to be received in the vagina and against the external os of the cervix, the second occlusion member being axially translatable relative to the first occlusion member, wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os, wherein the first occlusion member comprises an evertible cylindrical surface connected to the distal end of the tubular body which assumes a conical configuration which diverges in the radial direction upon axial translation of the tubular body which axially compresses and radially expands the evertible cylindrical surface;

a tubular shaft having a proximal end, a distal end, and a lumen extending therebetween, wherein the tubular shaft is slidably disposed within the lumen of the tubular body with the distal end of the tubular shaft attached to a distal end of the evertible cylindrical surface, wherein the distal end of the tubular body is attached to a proximal end of the evertible cylindrical surface, wherein distal translation of the body relative to the shaft will axially compress and radially expand the evertible cylindrical surface; and

a handle assembly which is removable from the body and the shaft, and wherein the handle includes a first lever, means for coupling the first lever to the tubular shaft, a second lever, and means for coupling the second lever to the tubular body, wherein manual actuation of the levers expands the first occlusion member.

18. A transcervical uterine access device comprising:

an insulated tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body;

a second occlusion member proximally spaced-apart from the first occlusion member and sized to be received in the vagina and against the external os of the cervix, the second occlusion member being axially translatable relative to the first occlusion member, wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os.

19. A transcervical uterine access device as in claim 18, wherein the first occlusion member is expansible from a collapsed configuration closely conforming to the exterior surface of the tubular body to a conical configuration which diverges in the distal direction.

20. A transcervical uterine access device as in claim 19, wherein the second occlusion member has a conical configuration which diverges in the proximal direction so that the first and second occlusion members when brought together define a neck having opposed tapered walls.

21. A transcervical uterine access device as in claim 18, wherein the first occlusion member comprises an evertible surface constructed of an elastomeric sheet covering a mesh.

22. A transcervical uterine access device comprising:

an insulated tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body; and

a second occlusion member proximally spaced-apart from the first occlusion member, wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os.

23. A transcervical uterine access device comprising:

a tubular body having a proximal end, a distal end, and a lumen extending therebetween;

a first expansible occlusion member disposed near the distal end of the tubular body;

a second occlusion member proximally spaced-apart from the first occlusion member and sized to be received in the vagina and against the external os of the cervix;

wherein the first and second occlusion members define a reduced-diameter neck therebetween for receiving the cervical os; and

a sealing sub-assembly slidably held over the tubular body, the sealing sub-assembly comprising a locking member and a biasing member, the biasing member connecting the locking member and the second occlusion member, wherein the locking member may be secured to the tubular body with the biasing member biasing the second occlusion member against the external os of the cervix.

24. A method for providing an access lumen to a patient'"'"'s uterus said method comprising:

introducing a tubular body through the cervical canal into the uterus;

expanding a first occlusion member over an exterior surface of the tubular body against the internal surface of the cervical os;

axially translating a second occlusion member relative to the first occlusion member to engage the second occlusion member against a surface of the external cervical os, wherein sufficient sealing force is provided to substantially inhibit loss of pressurized fluid from the uterus into the vagina; and

directing a heated fluid through the tubular body and providing insulation to the tubular body to substantially inhibit heat from the fluid from transferring through the tubular body to the cervix, vagina, or surrounding tissue.

25. A method as in claim 24, wherein the first occlusion member is in a collapsed configuration which closely conforms the exterior surface when the tubular body is introduced through the cervical canal and is expanded to a conical configuration with a surface that engages the internal surface of the internal cervical os.

26. A method as in claim 25, wherein the first occlusion member comprises an evertible cylindrical surface which is expanded by axially compressing the cylindrical surface to cause the distal end to expand radially.

27. A method as in claim 26, wherein the evertible cylindrical surface comprises an elastomeric sheet covering a mesh.

28. A method as in claim 24, further comprising engaging a second occlusion member on the tubular body against a surface of the external cervical os to enhance anchoring and sealing.

29. A method as in claim 28, wherein the second occlusion member has a conical surface which is engaged against the surface of the external cervical os by axially translating the second occlusion member over the tubular body.

30. A method for providing an access lumen to a patient'"'"'s uterus said method comprising:

introducing a tubular body through the cervical canal into the uterus;

expanding a first occlusion member over an exterior surface of the tubular body against the internal surface of the cervical os, wherein sufficient sealing force is provided to substantially inhibit loss of pressurized fluid from the uterus into the vagina; and

directing a heated fluid through the tubular body and providing insulation to the tubular body to substantially inhibit heat from the fluid from transferring through the tubular body to the cervix, vagina, or surrounding tissue.

31. A method for providing an access lumen to a patient'"'"'s uterus said method comprising:

introducing a tubular body through the cervical canal into the uterus;

expanding a first occlusion member over an exterior surface of the tubular body against the internal surface of the cervical os, wherein sufficient sealing force is provided to substantially inhibit loss of pressurized fluid from the uterus into the vagina;

wherein the first occlusion member is in a collapsed configuration which closely conforms the exterior surface when the tubular body is introduced through the cervical canal and is expanded to a conical configuration with a surface that engages the internal surface of the internal cervical os; and

wherein the first occlusion member comprises an evertible cylindrical surface which is expanded by axially compressing the cylindrical surface to cause the distal end to expand radially.

32. A method for providing an access lumen to a patient'"'"'s uterus said method comprising:

introducing a tubular body through the cervical canal into the uterus;

expanding a first occlusion member over an exterior surface of the tubular body against the internal surface of the cervical os;

axially translating a second occlusion member relative to the first occlusion member to engage the second occlusion member against a surface of the external cervical os, wherein sufficient sealing force is provided to substantially inhibit loss of pressurized fluid from the uterus into the vagina;

wherein the first occlusion member is in a collapsed configuration which closely conforms the exterior surface when the tubular body is introduced through the cervical canal and is expanded to a conical configuration with a surface that engages the internal surface of the internal cervical os; and

wherein the first occlusion member comprises an evertible cylindrical surface which is expanded by axially compressing the cylindrical surface to cause the distal end to expand radially.

33. A method as in claim 32, further comprising directing a heated fluid through the tubular body and providing insulation to the tubular body to substantially inhibit heat from the fluid from transferring through the tubular body to the cervix, vagina, or surrounding tissue.