Short term treatment for uterine disorder

• US 20060106109A1
• Filed: 10/24/2005
• Published: 05/18/2006
• Est. Priority Date: 10/27/2004
• Status: Active Grant

• Current Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Original Assignee: Vascular Control Systems, Inc. (Johnson & Johnson)
• Inventors: Jones, Michael L., Burbank, Fred H., Olson, Ed, Altieri, Greig E.
• Granted Patent: US 7,875,036 B2
• Time in Patent Office: Days
• US Class Current: 514/561
• 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 17/282 Jaws
• 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

Abstract

This invention is directed to a method and device for treating a female patient'"'"'s uterine disorder by occluding one or both of the patient'"'"'s uterine artery. The treatment embodying features of the invention basically involves occluding one or both of the patient'"'"'s uterine arteries with an intravaginal device to form a thrombus within the occluded artery or arteries and administering an agent which will prolong the occlusion of the artery or arteries after removal of the occluding device or initiate or accelerate fibroid cell apoptosis (programmed cell death). The intravaginal device has a pair of pivotally connected occluding members, with at least one of the occluding member having a movable occluding element on a distal shaft section of the occluding member.

Claims

1. A method of treating a female patient with a uterine disorder, comprising:

a. occluding at least one of the patients uterine arteries; and

b. administering to the patient effective amounts of an agent to the patient'"'"'s blood which retards lysis of thrombus formed from the uterine artery occlusion.

2. The method of claim 1 wherein the agent is a plasminogen binding agent.

3. The method of claim 2 wherein the plasminogen binding agent is selected from the group of binding agents consisting of tranexamic acid, ethamsylate, acexamic acid, aminocaproic acid, aprotinin, and combinations thereof.

4. The method of claim 1 wherein a blood flow detector is used to locate the patient'"'"'s uterine artery to be occluded.

5. The method of claim 4 wherein the blood flow detector is utilized to detect the occlusion of the uterine artery by detecting reduction or termination of blood flow through the uterine artery.

6. The method of claim 1 wherein the pressure of the uterine artery occlusion is terminated after a period of not more than three hours.

7. The method of claim 1 wherein the uterine artery occlusion is terminated after a period of about 1 to about 2 hours.

8. A method of treating a female patient with at least one uterine fibroid, comprising:

a. occluding at least one of the patients uterine arteries; and

b. generating within or administering to the patient effective amounts of at least one agent selected from the group consisting of an agent to retard lysis of thrombus formed from the uterine artery occlusion, an agent to retard blood flow, an agent to stimulate Bax and/or Bak activity and an agent to reduce Bcl-2 activity.

9. A method of treating a female patient with a uterine disorder by occluding at least one of the patients uterine arteries, comprising:

a. providing an occluding device having a pair of occluding members wherein at least one of the occluding members has a distal shaft section with an occluding element which is configured to move with respect to the distal shaft section;

b. advancing the occluding device through the patient'"'"'s vaginal canal until a pressure applying surface on a distal tip of the occluding element of the occluding device is adjacent to the patient'"'"'s vagina fornix;

c. pressing the pressure applying surface of the occluding device against the patient'"'"'s vaginal fornix to distend the vaginal wall to at least partially occlude an underlying uterine artery; and

d. maintaining the pressure applying surface of the distal tip of the occluding member pressed against the patient'"'"'s vaginal fornix to occlude the uterine artery for a time sufficient to form occlusive thrombus within the occluded uterine artery; and

e. maintaining effective amounts an agent in the patient'"'"'s blood which enhances the effects of the occlusion of the patient'"'"'s uterine artery.

10. The method of claim 9 wherein the agent is an anti-fibrinolytic agent which at least retard lysis of the occlusive thrombus formed in the occluded uterine artery.

11. The method of claim 10 wherein the anti-fibrinolytic agent is a plasminogen binding agent.

12. The method of claim 11 wherein the plasminogen binding agent is selected from the group consisting of tranexamic acid, acexamic acid and ethanamsylate.

13. The method of claim 10 wherein the anti-fibrinolytic agent is selected from the group consisting of aminocaproic acid and aprotinin.

14. The method of claim 9 wherein the agent is misoprostol to decrease uterine artery blood flow.

15. The method of claim 9, wherein a blood flow detector is provided on the occluding element to locate the patient'"'"'s uterine artery to be occluded.

16. The method of claim 15, wherein the blood flow detector is utilized to detect the occlusion of the uterine artery by detecting reduction or termination of blood flow through the uterine artery.

17. The method of claim 9 wherein the pressure of the pressure applying surface against the patient'"'"'s vaginal fornix is released after a period of not more than three hours.

18. The method of claim 9 wherein the pressure of the pressure applying surface against the patient'"'"'s vaginal fornix is released after a period of about 1 to about 2 hours.

19. The method of claim 9 wherein the position of the occluding element is adjusted by rotating the occluding element about a point in a plane in-line with the distal shaft section.

20. The method of claim 9 wherein the position of the occluding element is adjusted by extending at least part of the occluding element radially away from the distal shaft section of the occluding device.

21. An intravaginal device for treating a female patient'"'"'s uterine disorder by occluding at least one of the patient'"'"'s uterine arteries, comprising:

a. a first clamping member which has

i. an elongated handle with a proximal handle portion configured to extend out of the patient during treatment and be manipulated by an operator, which has a distal handle portion having a pivot point and which is configured to rotate in a plane about the pivot point, and

ii. a paddle-shaped jaw which is secured to the distal handle portion, which has a distal tip with a pressure applying surface, which has an inside tissue receiving recess proximal to the pressure applying surface with upper and lower longitudinally oriented sides proximal to the distal tip defining in part the tissue receiving recess, with the upper longitudinally oriented side in line with the distal handle portion and the lower longitudinally oriented side spaced away from the upper longitudinally oriented side; and

b. a second clamping member which has

i. an elongated handle with a proximal handle portion configured to extend out of the patient during treatment and be manipulated by an operator along with the proximal handle portion of the first clamping member, which has a distal handle portion having a pivot point pivotally secured to the pivot point of the handle of the first clamping member, and

ii. which has a distal shaft section with an open paddle-shaped jaw having a distal tip with a pressure applying surface opposed to the pressure applying surface of the first clamping member, a tissue receiving recess proximal to the pressure applying surface extending away from the tissue receiving recess of the first clamping member, a pair of longitudinally oriented sides, with one of the sides in the rotational plane of the intermediate shaft section and one in a rotational plane spaced from the rotational plane of the intermediate shaft section.

22. The intravaginal device of claim 21 wherein each of the proximal shaft sections of the clamping members include a grip configured to receive an operator'"'"'s finger.

23. The intravaginal device of claim 21 wherein at least one of the clamping members has a blood flow sensor on its distal tip for detecting the location of the patient'"'"'s uterine artery.

24. The intravaginal device of claim 21 wherein the blood flow sensor is a Doppler crystal.

25. The intravaginal device of claim 24 wherein the Doppler crystal is mounted in the pressure applying surface of the distal tip.

26. The intravaginal device of claim 25 wherein the Doppler crystal has a direction of view away from the pressure applying surface.

27. The intravaginal device of claim 21 wherein the pair of longitudinally oriented sides of the clamping members are spaced apart a distance of about 1 to about 20 mm.

28. The intravaginal device of claim 27 wherein the pair of longitudinally oriented sides of the clamping members are spaced apart a distance of about 5 to about 10 mm.

29. The intravaginal device of claim 21 wherein the distal end of the paddle-shaped jaw of the first clamping member and the distal end of the paddle-shaped jaw of the second clamping member are configured to engage a patient'"'"'s vaginal fornix on opposite sides of the patient'"'"'s uterine cervix.

30. The intravaginal device of claim 21 wherein the device is mounted to a tenaculum like device to guide the device to the patient'"'"'s uterine cervix.

31. The intravaginal device of claim 21 wherein the device has a shoe slider on the underside of the device for mounting the device to the tenaculum like device.