Method to stop bleeding, with short hemostasis duration using a low dose of anticoagulant

• US 10,213,214 B2
• Filed: 09/21/2018
• Issued: 02/26/2019
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: Pancholy, Samir Bipin
• Primary Examiner(s): Yabut, Diane D
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US16/138,958
• Publication Number:
  US 20190021743A1
• Time in Patent Office: 158 Days
• Field of Search: 606201-203, 601132, 601151, 601 33, 601 40
• 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 17/1325 with means for applying local pressure pressure pads A61F5/30
• CPC Class Codes: A61B 17/135 inflatable for measuring blood pressure A61B5/022; inflatable pressure pads A61F5/34
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding

Abstract

Disclosed are methods and devices for obtaining patent hemostasis of the radial artery by compressing the uninstrumented ulnar artery to increase radial artery flow. The device comprises a band having an inflatable bladder for applying blunt pressure to the ulnar artery. The method comprises applying a pressure to the homolateral ulnar artery and applying a pressure to the radial artery at the access site to obtain hemostasis at the access site.

Claims

1. A method of reducing a dosage of an anticoagulant when performing a catheterization procedure at an access site of a radial artery, comprising:

(a) administering the anticoagulant at a dose less than a conventional dose of an equivalent of 50 units of unfractionated heparin per kg of body weight;

(b) reducing a contact time of blood at the access site of the radial artery by increasing a velocity of blood in the radial artery, said velocity of blood being increased by increasing a flow of blood in the radial artery, wherein the flow of blood in the radial artery is increased by applying an ulnar pressure on an ipsilateral ulnar artery at an ulnar pressure site by inflating at least a first bladder to compress the ulnar artery fully;

(c) maintaining the contact time of blood at a reduced level for a period of time during the catheterization procedure;

(d) applying a radial pressure on the radial artery by inflating at least a second bladder at the access site to stop bleeding at the access site;

(e) continuing to apply the radial pressure on the radial artery for a duration of time at least until hemostasis of the radial artery is attained;

(f) continuing to apply the ulnar pressure on the ulnar artery at the ulnar pressure site to compress the ulnar artery fully for a first period of time, wherein the first period of time is either about 15 minutes or about 30 minutes; and

(g) attaining hemostasis of the radial artery.

2. The method of claim 1, wherein the dose of the anticoagulant is in a range from an equivalent of about 15 units of unfractionated heparin per kg of body weight to an equivalent of about 30 units of unfractionated heparin per kg of body weight.

3. The method of claim 1, wherein the dose of the anticoagulant is in a range from an equivalent of about 20 units of unfractionated heparin per kg of body weight to an equivalent of about 40 units of unfractionated heparin per kg of body weight.

4. The method of claim 1, wherein the dose of the anticoagulant is less than an equivalent of 25 units of unfractionated heparin per kg of body weight.

5. The method of claim 1, wherein the duration of time in step (e) is less than 120 minutes.

6. The method of claim 1, wherein the duration of time in step (e) is about 60 minutes.

7. The method of claim 1, wherein the radial pressure and the ulnar pressure are applied using a band comprising at least two inflatable bladders, said bladders being the first bladder and the second bladder.

8. The method of claim 1, wherein the ulnar pressure site is a Guyon'"'"'s canal.

9. The method of claim 1, wherein the anticoagulant is selected from a group consisting of:

heparin, dalteparin, danaparoid, enoxaparin, unfractionated heparin, low molecular weight heparin, direct thrombin inhibitors including hirudin, argatroban, bivalirudin, and combinations or derivatives thereof.

10. The method of claim 1, wherein step (b) precedes step (d).

11. The method of claim 1, wherein step (d) precedes step (b).

12. The method of claim 1, further comprising a step of confirming patency of the radial artery.

13. The method of claim 1, wherein the first period of time in step (f) is about 30 minutes.

14. The method of claim 1, wherein the first period of time in step (f) is about 15 minutes.

15. The method of claim 1, wherein the ulnar pressure is reduced to zero after the first period of time.

16. The method of claim 1, wherein the ulnar pressure is reduced to compress the ulnar artery partially for a second period of time following the first period of time.

17. The method of claim 16, wherein the ulnar pressure is applied to compress the ulnar artery partially at least until hemostasis of the radial artery is attained.

18. The method of claim 16, wherein a sum of the first and the second periods of time for compressing the ulnar artery is less than the duration of time for hemostasis of the radial artery.

19. A method of reducing a dosage of an anticoagulant when performing a catheterization procedure at an access site of a radial artery, comprising:

(a) administering the anticoagulant at a dose less than a conventional dose of an equivalent of 50 units of unfractionated heparin per kg of body weight;

(b) reducing a contact time of blood at the access site of the radial artery by increasing a velocity of blood in the radial artery, said velocity of blood being increased by increasing a flow of blood in the radial artery;

(c) maintaining the contact time of blood at a reduced level for a first period of time during the catheterization procedure;

(d) compressing the radial artery at the access site for a duration of time to attain hemostasis of the radial artery; and

(e) confirming patency of the radial artery;

wherein;

(i) step (c) is performed simultaneously with step (d) and the period of time in step (c) is less than the duration of time in step (d); and

(ii) the flow of blood in the radial artery is increased by fully compressing the ulnar artery;

(iii) wherein the period of time in step (c) is either 15 minutes or 30 minutes.

20. The method of claim 19, wherein the dose of the anticoagulant is in a range from an equivalent of about 15 units of unfractionated heparin per kg of body weight to an equivalent of about 30 units of unfractionated heparin per kg of body weight.

21. The method of claim 19, wherein the dose of the anticoagulant is in a range from an equivalent of about 20 units of unfractionated heparin per kg of body weight to an equivalent of about 40 units of unfractionated heparin per kg of body weight.

22. The method of claim 19, wherein the dose of the anticoagulant is less than an equivalent of 25 units of unfractionated heparin per kg of body weight.

23. The method of claim 19, wherein the duration of time in step (d) is less than 120 minutes.

24. The method of claim 19, wherein the duration of time in step (d) is about 60 minutes.

25. The method of claim 19, wherein the radial pressure and the ulnar pressure are applied using a band comprising at least two inflatable bladders.

26. The method of claim 19, wherein the ulnar pressure is applied at a Guyon'"'"'s canal.

27. The method of claim 19, wherein the anticoagulant is selected from a group consisting of:

heparin, dalteparin, danaparoid, enoxaparin, unfractionated heparin, low molecular weight heparin, direct thrombin inhibitors including hirudin, argatroban, bivalirudin, and combinations or derivatives thereof.

28. The method of claim 19, wherein the first period of time in step (c) is about 30 minutes.

29. The method of claim 19, wherein the first period of time in step (c) is about 15 minutes.

30. The method of claim 19, wherein the ulnar pressure is reduced to zero after the first period of time.