Methods and devices for conduit occlusion

• US 9,308,023 B2
• Filed: 05/06/2015
• Issued: 04/12/2016
• Est. Priority Date: 02/25/2004
• Status: Active Grant

• Current Assignee: Femasys, Inc.
• Original Assignee: Femasys, Inc.
• Inventors: Lee-Sepsick, Kathy, Paxton, Lani L. L., Marcus, Jeffrey A., Williams, Stephen N.
• Primary Examiner(s): Tran, Susan
• Assistant Examiner(s): CRAIGO, WILLIAM A
• Application Number:
  US14/705,390
• Publication Number:
  US 20150282839A1
• Time in Patent Office: 342 Days
• Field of Search: None
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• 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 2017/1205 Introduction devices
• 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: A61F 2/954 for placing stents or stent-grafts in a bifurcation
• CPC Class Codes: A61F 6/225 transcervical
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence

Abstract

The present invention comprises systems, methods and devices for the delivery of compositions for occluding or of means for opening conduits. The implantable occlusive material may be delivered pre-formed or in situ cured and, may be a resorbable material that supports tissue ingrowth that eventually replaces the material leaving little or no original material in place. The delivery system is positioned to allow for placement of the occlusive material into the body conduit. Use of delivery systems, methods and devices for re-opening an occluded body conduit are also included.

Claims

1. A method for occluding one fallopian tube in a mammal, comprising,

a) providing a delivery system that delivers an effective amount of an occlusive material composition, the delivery system comprising a delivery device comprising at least a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed closed tip, the introducer shaft defining a catheter channel along the interior length of the introducer shaft and defining a respective catheter channel opening spaced proximally from the closed tip of the introducer shaft, wherein the catheter channel is configured for providing a respective catheter;

one catheter having a delivery end comprising an end structure, wherein the catheter is configured to be received therein the catheter channel of the introducer shaft; and

means for providing an occlusive material composition into and through the catheter;

b) inserting the introducer shaft therethrough a cervix of the mammal until the closed tip contacts a uterine fundus of the mammal, and the catheter channel opening is directed toward a uterine cornua of the mammal;

c) moving the catheter therethrough the catheter channel until the delivery end of the catheter exits the catheter channel opening and the delivery end of the catheter is located within the uterine cornua and the end structure is at or near a tubal ostium, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the occlusive material composition; and

d) delivering an effective amount of an occlusive material composition through and out the delivery end of the catheter so that a fallopian tube is occluded.

2. The method of claim 1, wherein the delivery system further comprises a delivery device stabilizer movably positioned thereon the introducer shaft, the method further comprising, after inserting the introducer shaft therethrough the cervix of the mammal, moving the delivery device stabilizer to a selected position along the introducer shaft to maintain the position of the closed tip on the uterine fundus.

3. The method of claim 1, further comprising,

e) moving the catheter delivery end toward the catheter opening;

and

f) withdrawing the introducer shaft from the cervix of the mammal, thereby removing the delivery system from the mammal.

4. A method for occluding two fallopian tubes in a mammal, comprising,

a) providing a delivery system that delivers an effective amount of an occlusive material composition, the delivery system comprising a delivery device comprising at least a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed closed tip, the introducer shaft defining two catheter channels along the interior length of the introducer shaft and defining two respective catheter channel openings spaced proximally from the closed tip of the introducer shaft, wherein each catheter channel is configured for providing a respective catheter;

two catheters each having a delivery end, wherein each delivery end comprises an end structure, and wherein each catheter is configured to be received therein each catheter channel of the introducer shaft; and

means for providing the occlusive material composition into and through each catheter;

b) inserting the introducer shaft therethrough a cervix of the mammal until the closed tip contacts a uterine fundus of the mammal, and each catheter channel opening is directed toward a uterine cornua of the mammal;

c) moving each catheter therethrough the respective catheter channel until the delivery end of each catheter exits the respective catheter channel opening and the delivery end of each catheter is located within the uterine cornua and the end structure is at or near a tubal ostium, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the occlusive material composition; and

d) delivering an effective amount of an occlusive material composition through and out the delivery end of each catheter so that a fallopian tube is occluded.

5. The method of claim 4, wherein the delivery system further comprises a delivery device stabilizer movably positioned thereon the introducer shaft, the method further comprising, after inserting the introducer shaft therethrough the cervix of the mammal, moving the delivery device stabilizer to a selected position along the introducer shaft to maintain the position of the closed tip on the uterine fundus.

6. The method of claim 4, further comprising,

e) moving the catheter delivery end toward the catheter opening;

and

f) withdrawing the introducer shaft from the cervix of the mammal, thereby removing the delivery system from the mammal.

7. A method for delivering a fluid composition to one or two fallopian tubes in a mammal, comprising,

a) providing a delivery system that delivers an effective amount of a fluid composition the delivery system comprising a delivery device comprising at least a handle;

an introducer shaft having a proximal end operatively connected to the handle and an opposed closed tip, the introducer shaft defining one or two catheter channels along the interior length of the introducer shaft and defining one or two respective catheter channel openings spaced proximally from the closed tip of the introducer shaft, wherein one or two catheter channels are configured for providing a respective catheter;

one or two dual lumen balloon catheters having a delivery end and an end structure, wherein one or two catheters are configured to be received therein a respective catheter channel of the introducer shaft; and

means for providing the fluid composition into and through the one or two catheters;

b) inserting the introducer shaft therethrough a cervix of the mammal until the closed tip contacts a uterine fundus of the mammal, wherein when the closed tip contacts the uterine fundus, the one or two catheter channel openings are directed toward a uterine cornua of the mammal;

c) moving one or two catheters therethrough one or two catheter channels until the delivery end of one or two catheters exits the catheter channel opening and the delivery end of one or two catheters is located at or near at least one uterine cornua, wherein the end structure maintains the delivery end in the uterine cornua and aids in localized delivery of the fluid composition;

d) delivering from one or two catheters to one or two tubal ostia and a portion of its fallopian tube an effective amount of a fluid composition.

8. The method of claim 7, wherein the delivery system further comprises a delivery device stabilizer movably positioned thereon the introducer shaft, the method further comprising, after inserting the introducer shaft therethrough the cervix of the mammal, moving the delivery device stabilizer to a selected position along the introducer shaft to maintain the position of the closed tip on the uterine fundus.