CA2546341A1 - Uterine artery occlusion device with cervical receptacle - Google Patents

Uterine artery occlusion device with cervical receptacle Download PDF

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Publication number
CA2546341A1
CA2546341A1 CA002546341A CA2546341A CA2546341A1 CA 2546341 A1 CA2546341 A1 CA 2546341A1 CA 002546341 A CA002546341 A CA 002546341A CA 2546341 A CA2546341 A CA 2546341A CA 2546341 A1 CA2546341 A1 CA 2546341A1
Authority
CA
Canada
Prior art keywords
receptacle
patient
uterine
cervical
distal end
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CA002546341A
Other languages
French (fr)
Other versions
CA2546341C (en
Inventor
Fred H. Burbank
Michael L. Jones
Greig E. Altieri
Guillermo Elizondo-Riojas
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Vascular Control Systems Inc
Original Assignee
Vascular Control Systems, Inc.
Fred H. Burbank
Michael L. Jones
Greig E. Altieri
Guillermo Elizondo-Riojas
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Vascular Control Systems, Inc., Fred H. Burbank, Michael L. Jones, Greig E. Altieri, Guillermo Elizondo-Riojas filed Critical Vascular Control Systems, Inc.
Publication of CA2546341A1 publication Critical patent/CA2546341A1/en
Application granted granted Critical
Publication of CA2546341C publication Critical patent/CA2546341C/en
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
    • A61B5/6834—Means for maintaining contact with the body using vacuum
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/02—Detecting, measuring or recording pulse, heart rate, blood pressure or blood flow; Combined pulse/heart-rate/blood pressure determination; Evaluating a cardiovascular condition not otherwise provided for, e.g. using combinations of techniques provided for in this group with electrocardiography or electroauscultation; Heart catheters for measuring blood pressure
    • A61B5/026—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/48—Other medical applications
    • A61B5/4887—Locating particular structures in or on the body
    • A61B5/489—Blood vessels
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/06—Measuring blood flow
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/42—Gynaecological or obstetrical instruments or methods
    • A61B2017/4216—Operations on uterus, e.g. endometrium

Abstract

An intravaginal uterine artery occlusion device is used for treating uterine disorders such as fibroids, dysfunctional uterine bleeding, postpartum hemorrhage and the like. A occlusion device has a cervical receptacle with an open distal end for receiving the patients uterine cervix, an elongated shaft having a distal end secured to the closed proximal end of the cervical receptacle, and an inner lumen extending to the distal end of the shaft. The patient's uterine cervix is held within the interior of the receptacle by the application of a vacuum to the interior of the receptacle through the inner lumen of the shaft while the leading edge(s) of the cervical receptacle press against the patient's vaginal fornix to occlude the uterine artery. A blood flow sensor may be provided on the leading edge of the receptacle to aid in locating a uterine artery and to monitor blood flow through the uterine artery.

Claims (42)

1. An intravaginal uterine artery occlusion device, comprising:
a. an elongated shaft which has a distal end, an inner lumen configured to be interconnected to a vacuum source and extending to the distal end; and b. a cervical receptacle which is secured to the distal end of the elongated shaft, which has an interior configured to receive at least part of a female patient's uterine cervix and which has at least one pressure applying surface to facilitate occlusion of the patient's uterine artery.
2. The device of claim 1 wherein the interior of the cervical receptacle in configured to be in fluid communication with the inner lumen in the shaft
3. The device of claim 1 wherein cervical receptacle is disposed about the patient's uterine cervix when the pressure applying surface is distally extendable to apply pressure to the patient's vaginal fornix.
4. The device of claim 3 wherein the pressure applying surface is part of a distally extendable curtain which has a proximal end secured to the cervical receptacle and a distal end secured to the pressure applying surface.
5. The device of claim 4 wherein the at least one extendable curtain comprises inflatable members.
6. The device of claim 4 wherein the at least one extendable curtain is cylindrically shaped.
7. The device of claim 4 including a pair of opposed extendable curtains, with each curtain having a proximal end secured to the cervical receptacle and a distal end secured to a pressure applying surface.
8. The device of claim 6 wherein the at least one extendable curtain comprise inflatable members.
9. The device of claim 1 wherein the leading edge has a blood flow sensor to facilitate location of the patient's uterine artery
10. The device of claim 3, wherein the blood flow sensor is a Doppler ultrasound sensor.
11. The device of claim 10, wherein the Doppler sensor is configured to sense ultrasound energy having a frequency of between about 5 MHz and about 19 MHz.
12. The device of claim 10, wherein the Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of between about 6 MHz and about 10 MHz.
13. The device of claim 4, wherein the Doppler ultrasound sensor is configured to sense ultrasound energy having a frequency of about 8 MHz.
14. The device of claim 1, wherein at least one blood flow sensor is disposed on the leading edge of the cervical receptacle and has a sensing direction distally away from the leading edge of the cervical receptacle to facilitate detection of the patient's uterine artery.
15. The device of claim 1 wherein at least one sensor is disposed on the leading edge of the cervical receptacle and has a forward looking sensing direction.
16. The device of claim 1 wherein the cervical receptacle has an elongated cervical sound within the interior thereof configured to be guided into a female patient's cervical canal to thereby position the receptacle about the exterior of the patient's cervix.
17. The device of claim 16 wherein the elongated cervical sound is provided with a rounded non-traumatic distal tip.
18. The device of claim 1 wherein the cervical receptacle has at least one groove in an inner surface.
19. The device of claim 17 wherein the at least one groove is parallel to a central axis of the receptacle.
20. The device of claim 1 wherein the interior of the receptacle is configured to receive the patient's cervix and part of the patient's vaginal fornix so that the leading edge of the receptacle applies sufficient pressure to the vaginal fornix to occlude the patient's uterine artery.
21. The device of claim 1 wherein the cervical receptacle has a lowered anterior lip which facilitates deploying the receptacle about the patient's uterine cervix.
22. The device of claim 1 wherein the pressure applying surface is part of an occlusion bar.
23. An intravaginal system for occluding a female patient's uterine artery, comprising:
a. a cervical receptacle which has an open distal end with at least one leading edge, a closed proximal end, an interior chamber configured to receive at least part of a female patient's uterine cervix through the open distal end, which has an opening in the closed proximal end;
b. at least one blood flow sensor in or on a leading edge of the cervical receptacle to facilitate location of the patient's uterine artery to be occluded; and c. an elongated shaft which has a proximal end and a distal end secured to the proximal end of the cervical receptacle, which has an inner lumen interconnected with a vacuum source at one end and in fluid communication with the opening in the closed proximal end of the receptacle at the other end.
24. The non-invasive blood vessel occlusion device of claim 22, comprising a plurality of sensors.
25. An intravaginal system for treating a female patient's uterine disorder by occluding at least one of the female patient's uterine arteries, comprising:
a. a uterine artery occlusion device having a cervical receptacle with an open distal end and a closed distal end, an interior chamber configured to receive at least part of the patient's uterine cervix through the open distal end, and an elongated shaft having an inner lumen which has a distal end in fluid communication with the interior of the receptacle and a proximal end configured for interconnection with a vacuum source;
b. means for inserting the uterine artery occlusion device within the patient's vaginal canal and advancing the device therein until the receptacle is adjacent to the patient's uterine cervix.
c. means for positioning the receptacle to receive at least part of the patient's uterine cervix within the interior chamber;
d. means for holding at least part of the patient's uterine cervix in the interior chamber; and e. means for pressing a leading edge of the receptacle against the female patient's vaginal fornix to occlude a uterine artery adjacent to the vaginal fornix.
26. The system of claim 25 wherein the uterine cervix in the interior chamber is a vacuum means.
27. The system of claim 25, wherein a blood flow sensor is provided on a leading edge of the cervical receptacle.
28. The system of claim 25, wherein said blood flow sensor comprises a Doppler ultrasound blood flow sensor.
29. The system of claim 25, further comprising detecting a change in blood flow in the uterine artery.
30. The system of claim 24, wherein the uterine artery remains occluded by pressure applied by the leading edge of the cervical receptacle for a limited time.
31. The system of claim 30, wherein the limited time ranges from about 0.2 to about 24 hours.
32. The system of claim 30, wherein the limited time ranges from about 0.5 to about 16 hours.
33. An intravaginal uterine artery occlusion device, comprising:
a. an elongated shaft which has a distal end, an inner lumen configured to be interconnected to a vacuum source and extending to the distal end;
b. a cervical receptacle which is secured to the distal end of the elongated shaft, which has an interior chamber configured to receive at least part of a female patient's uterine cervix, which is in configured to be in fluid communication with the inner lumen in the shaft and which has at least one pressure applying surface to facilitate occlusion of the patient's uterine artery; and c. at least one extendable pressure application member secured to the cervical receptacle having.
34. The intravaginal uterine artery occlusion device of claim 33 wherein the pressure application member includes an occlusion bar with a pressure applying surface.
35. The intravaginal uterine artery occlusion device of claim 34 wherein the occlusion bar is hydraulically operated to extend distal to the leading edge of the uterine cervix receptacle.
36. The intravaginal uterine artery occlusion device of claim 35 wherein the occlusion bar has a pair of legs which extend from a surface of the occlusion bar opposite to the pressure applying surface thereof.
37. The intravaginal occlusion device of claim 36 wherein the pressure application member has a pair of arms with recesses therein configured to receive the legs extending from the occlusion bar.
38. The intravaginal occlusion device of claim 37 wherein at least one of the arm receiving recesses is a bore and is provided with a drive shaft slidably disposed therein configured to drive the received leg.
39. The intravaginal occlusion device of claim 38 wherein the drive shaft is driven by a first cylindrical member with one closed end secured to the proximal end of the drive shaft and one open end and a second cylindrical member with one open end which interfits with the open end of the first cylindrical member and one closed end with an aperture through which the drive shaft is slidably disposed.
40. The intravaginal occlusion device of claim 39 wherein the open ends of the first and second cylindrical members are threadably engaged.
41. The intravaginal occlusion device of claim 40 wherein the open end of the first cylindrical member has a threaded exterior and the open end of the second cylindrical member has a threaded interior, whereby rotation of one of the cylindrical member with respect to the other cylindrical member adjusts the capacity of the fluid chamber.
42. The intravaginal occlusion device of claim 39 wherein drive shaft is slidably disposed within an elongated tubular member secured at a distal end to the pressure applying head and at a proximal end to the closed end of the second cylindrical member.
CA2546341A 2003-11-20 2004-11-15 Uterine artery occlusion device with cervical receptacle Expired - Fee Related CA2546341C (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US10/718,222 US7325546B2 (en) 2003-11-20 2003-11-20 Uterine artery occlusion device with cervical receptacle
US10/718,222 2003-11-20
PCT/US2004/038111 WO2005051211A1 (en) 2003-11-20 2004-11-15 Uterine artery occlusion device with cervical receptacle

Publications (2)

Publication Number Publication Date
CA2546341A1 true CA2546341A1 (en) 2005-06-09
CA2546341C CA2546341C (en) 2010-10-26

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Family Applications (1)

Application Number Title Priority Date Filing Date
CA2546341A Expired - Fee Related CA2546341C (en) 2003-11-20 2004-11-15 Uterine artery occlusion device with cervical receptacle

Country Status (8)

Country Link
US (1) US7325546B2 (en)
EP (1) EP1691697B1 (en)
JP (1) JP4699380B2 (en)
AT (1) ATE508697T1 (en)
AU (1) AU2004292421B2 (en)
CA (1) CA2546341C (en)
ES (1) ES2363433T3 (en)
WO (1) WO2005051211A1 (en)

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ES2363433T3 (en) 2011-08-04
US7325546B2 (en) 2008-02-05
EP1691697B1 (en) 2011-05-11
US20050113852A1 (en) 2005-05-26
AU2004292421A2 (en) 2005-06-09
AU2004292421A1 (en) 2005-06-09
CA2546341C (en) 2010-10-26
AU2004292421B2 (en) 2010-05-27
ATE508697T1 (en) 2011-05-15
WO2005051211A1 (en) 2005-06-09
JP4699380B2 (en) 2011-06-08
EP1691697A1 (en) 2006-08-23

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