Transcervical uterine access and sealing device

Claim 2

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.

Claim 3

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.

Claim 4

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.

Claim 5

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.

Claim 6

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

Claim 7

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

Claim 8

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

Claim 9

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

Claim 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 25 mm.

Claim 11

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.

Claim 12

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.

Claim 13

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.

Claim 14

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

Claim 15

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

Claim 16

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.

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

Claim 18

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.

Claim 19

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

Claim 20

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.

Claim 21

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.

Claim 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; 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.

Claim 23

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.

Claim 24

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.

Claim 25

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.

Claim 26

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.

Claim 27

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.

Claim 28

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.

Claim 29

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.

Claim 30

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.

Claim 33

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.

Claim 34

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.

Claim 35

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

Claim 36

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.

Claim 37

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.

Claim 44

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.