Multi-axial uterine artery identification, characterization, and occlusion pivoting devices and methods

• US 6,905,506 B2
• Filed: 03/28/2002
• Issued: 06/14/2005
• Est. Priority Date: 03/28/2001
• Status: Expired due to Fees

• Current Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Original Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Inventors: Jones, Michael L., Burbank, Fred H., Altieri, Greig E.
• Primary Examiner(s): Woo, Julian W.
• Application Number:
  US10/107,810
• Publication Number:
  US 20020188306A1
• Time in Patent Office: 1,174 Days
• Field of Search: 606/119, 606/157, 606/158, 606205-207, 606/210, 606/211, 600454-456, 600/462, 600/504, 128/898
• US Class Current: 606/205
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61B 17/12 for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord specially adapted for vas deferens or fallopian tubes A61F6/20; materials for ligaturing blood vessels A61L17/00
• CPC Class Codes: A61B 17/122 Clamps or clips , e.g. for the umbilical cord for the vas deferens A61F6/206
• CPC Class Codes: A61B 17/128 for applying or removing clamps or clips
• CPC Class Codes: A61B 17/1285 for minimally invasive surgery
• CPC Class Codes: A61B 17/2812 with a single pivotal connection A61B17/29 takes precedence
• 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 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/4216 Operations on uterus, e.g. endometrium
• CPC Class Codes: A61B 5/026 Measuring blood flow A61B3/1233, A61B3/1241 take precedence
• CPC Class Codes: A61B 5/415 the glands, e.g. tonsils, adenoids or thymus
• CPC Class Codes: A61B 5/418 lymph vessels, ducts or nodes
• CPC Class Codes: A61B 8/06 Measuring blood flow measuring volume flow in general G01F, e.g. G01F1/66, G01F1/72; measuring speed of fluids in general G01P5/00
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00

Abstract

A system is provided for compressing one or both of the uterine arteries of a patient which is at least in part shaped to complement the shape of the exterior of the cervix, which allows the system to be self-positioning. One or more Doppler chips can be mounted or incorporated into the system which permit the practitioner to better identify the uterine artery and monitor blood flow therein. The system includes a pair of pivotally joined elements which can be moved toward and away from the cervix to compress a uterine artery.

Claims

1. Elongated intravaginal device for treating a female patient'"'"'s uterine disorder by occluding uterine arteries thereof, comprising:

a first tong having an enlarged distal end, a pressure applying surface on the enlarged distal end, an elongated shaft and an operable proximal end configured to extend out of the patient to facilitate extracorporeal manipulation of the enlarged distal end of the first tong;

a second tong having an enlarged distal end, a pressure applying surface on the enlarged distal end and an elongated shaft and an operable proximal end configured to extend out of the patient to facilitate extracorporeal manipulation of the enlarged distal end of the second tong;

a pivotal connection between the first and second tongs at a location on their shafts proximally spaced from the enlarged distal ends of the first and second tongs; and

a blood flow sensing element on the enlarged distal ends of the first and second tongs configured to non-invasively locate the patient'"'"'s uterine arteries or to monitor blood flow therethrough.

2. The intravaginal device in accordance with claim 1, wherein at least one of the blood flow sensors is a Doppler crystal.

3. The intravaginal device in accordance with claim 2, wherein the Doppler crystal is releasably mounted in the enlarged distal end of the first or second tongs.

4. The intravaginal device in accordance with claim 2, wherein the Doppler crystal is integrally formed in the enlarged distal end of the first or second tong.

5. The intravaginal device in accordance with claim 2, wherein an enlarged distal end of the first or second tong has a plurality of Doppler crystals mounted in the pressure applying surface thereof.

6. The intravaginal device in accordance with claim 5, wherein a plurality of Doppler crystals have a parallel direction of view.

7. The intravaginal device in accordance with claim 5, wherein each of the tongs of has a longitudinal axis, and the Doppler crystals on the enlarged distal end of the first or second tong have a direction of view parallel to the longitudinal axis thereof.

8. The intravaginal device in accordance with claim 5, wherein a plurality of Doppler crystals in the enlarged distal end of the first or second tongs have diverging directions of view.

9. The intravaginal device in accordance with claim 5, wherein a first plurality of Doppler crystals in the enlarged distal end of the first or second tongs have a first direction of view perpendicular to the pressure applying surface of the enlarged distal end, and a second plurality of Doppler crystals have a second direction of view which is at an angle to the first direction of view.

10. The intravaginal device in accordance with claim 5, wherein the Doppler crystals are equally spaced from each other.

11. The intravaginal device in accordance with claim 1 wherein at least one Doppler crystal is mounted in the pressure applying surface of the enlarged distal end of the first or second tong and has a direction of view away from the pressure applying surface.

12. The intravaginal device in accordance with claim 1, wherein the enlarged distal end of the first tong has a side surface which is concave.

13. The intravaginal device in accordance with claim 12, wherein the concave side surface has an inner diameter between about 2 cm and about 4 cm.

14. The intravaginal device in accordance with claim 12, wherein the concave side surface has an inner diameter of about 3 cm.

15. The intravaginal device in accordance with claim 1, wherein both of the first and the second tongs have pressure applying surfaces which are concave and are oriented toward each other.

16. The intravaginal device in accordance with claim 1, wherein at least one of the first and second tongs comprises a loop.

17. The intravaginal device in accordance with claim 16, wherein the loop has an inner length greater than an inner width thereof.

18. The intravaginal device in accordance with claim 17, wherein the loop has an inner length greater than about 1.5 inches, and an inner width between about 0.75 inches and about 1.25 inches.

19. The intravaginal device in accordance with claim 17, wherein the loop has an inner length about 2 inches, and an inner width about 0.8 inches.

20. A method of treating a female patient'"'"'s uterine disorder by bilaterally occluding both uterine arteries thereof, comprising:

providing an intravaginal instrument comprising a first tong with an enlarged head on a distal end, a pressure applying surface on the enlarged head, an elongated shaft and an operable proximal end configured to extend out of the patient and a second tong having an enlarged head on a distal end, a pressure applying surface on the enlarged head, an elongated shaft and an operable proximal end configured to extend out of the patient and a pivotal connection between the first and second tongs at a location between the enlarged heads and the proximal end of the tongs;

advancing the intravaginal instrument through a vaginal canal toward a cervix of the patient'"'"'s uterus until the enlarged heads of the tongs are pressing against vaginal fornices on opposite sides of the patients uterine cervix;

adjusting the positions of the enlarged heads of the intravaginal instrument to press the pressure applying surfaces of the enlarged heads against the vaginal fornices on opposite sides of the patient'"'"'s uterine cervix to compress both of the underlying uterine arteries to at least partially occlude the uterine arteries.

21. A method in accordance with claim 20, wherein blood flow through the uterine arteries are detected with Doppler crystals disposed on the enlarged heads.

22. A method in accordance with claim 20, wherein the application of pressure by the enlarged heads against the vaginal fornices on opposite sides of the uterine cervix are reduced after at least one blood flow sensor indicates that blood flow through one of the uterine arteries has ceased for a predetermined period.

23. A method in accordance with claim 22, wherein the female patient has at least one fibroid and the predetermine time period is selected to reduce the blood supply to the at least one fibroid sufficiently to cause necrosis of fibroid tissue of the at least one fibroid.

24. A method in accordance with claim 22, wherein the female patient has DUB;

and the predetermined time period is selected to reduce bleeding from the patient'"'"'s uterus.

25. A method in accordance with claim 22, wherein the female patient is bleeding from a Caesarian incision;

and the predetermined period is selected to reduce bleeding from the Caesarian incision.

26. A method in accordance with claim 22, wherein the female patient has PPH;

and the predetermined period is selected to reduce bleeding from the patient'"'"'s uterus.

27. A method in accordance with claim 20, wherein the instrument is removed from the female patient after the predetermined time period.

28. A method in accordance with claim 20, wherein the uterine arteries are located with Doppler crystals disposed on the enlarged heads.

29. A method of treating a female human patient with a dysfunctional uterine condition by occluding the patient'"'"'s uterine arteries comprising:

a. providing an intravaginal instrument having a first tong with an enlarged head on a distal end thereof, a pressure applying surface on the enlarged head, an elongated handle secured to the enlarged head and an operable proximal end configured to extend out of the patient'"'"'s vaginal opening and a second tong with an enlarged head on a distal end thereof, a pressure applying surface on the enlarged head and an elongated handle secured to the enlarged head and an operable proximal end configured to extend out of the patient'"'"'s vaginal opening and a pivotal connection between the handles of the first and second tongs at a location between the enlarged heads and the proximal end thereof;

b. advancing the intravaginal instrument through the patient'"'"'s vaginal canal toward the patients uterine cervix until the enlarged heads of the tongs are located on opposite sides of the patient'"'"'s uterine cervix and pressure applying surfaces of the enlarged heads are pressing against the vaginal fornix; and

c. adjusting the positions of the heads of the intravaginal instrument to press the pressure applying surfaces of the enlarged heads against the vaginal fornix in contact therewith on both sides of the uterine cervix to compress the underlying uterine arteries against the uterus to at least partially occlude the underlying uterine arteries.

30. An intravaginal occlusive device for treating a female patient'"'"'s dysfunctional uterus by bilaterally occluding both uterine arteries thereof, comprising:

a) a first elongated clamping member which has a first proximal section with a manipulative handle configured to extend out of the patient'"'"'s vaginal canal when the device is in position to occlude the patient'"'"'s uterine arteries and which has a first enlarged distal section having a damping surface configured to engage the patient'"'"'s vaginal fornix on one side of the patient'"'"'s uterine cervix and apply pressure thereto to occlude a first underlying uterine artery;

b) a second elongated clamping member which has a second proximal section with a manipulative handle configured to extend out of the patient'"'"'s vagina when the device is in position to occlude the patient'"'"'s uterine artery and which has a second enlarged distal section having a damping surface configured to engage the patient'"'"'s vaginal fornix on a second side of the patient'"'"'s uterine cervix and apply pressure thereto to occlude a second underlying uterine artery;

c) a pivotal connection between the first and second elongated clamping members at a location proximally spaced from the enlarged distal sections thereof; and

d) at least one blood flow sensor on the first and second enlarged distal sections having an inwardly directed view when the clamping members are in a closed configuration.

31. The intravaginal occlusive device of claim 30 wherein at least one of the clamping members has a tissue receiving recess between the tissue contacting surface and the pivotal connection thereof.

32. The intravaginal device of claim 30 wherein the blood flow sensors are on both pressure applying surfaces of the enlarged heads.

33. The intravaginal device of claim 32 wherein at least one blood flow sensor is a Doppler ultrasound sensor.

34. The intravaginal device of claim 30 wherein the handles of the first and second pressure applying members are provided with finger grips to facilitate the extracorporeal manipulation of the pressure applying members.