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

• US 9,949,738 B2
• Filed: 02/07/2017
• Issued: 04/24/2018
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: Pancholy, Samir Bipin
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US15/426,056
• Publication Number:
  US 20170143346A1
• Time in Patent Office: 441 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 17/12009 Implements for ligaturing other than by clamps or clips, e.g. using a loop with a slip knot
• 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. The method further comprises administering an anticoagulant to a patient at a dose ranging from about 20 units per kg of body weight to about 30 units per kg of body weight.

Claims

1. A method of obtaining hemostasis of a radial artery of a patient when performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:

(a) administering a dose of anticoagulant to the patient during the catheterization procedure;

(b) applying an ulnar pressure to an ulnar artery at an ulnar pressure site, thereby providing an increased flow of blood in the radial artery;

(c) applying a hemostatic pressure to the radial artery at the access site for a duration of time at least until hemostasis of the radial artery;

(d) maintaining simultaneously the hemostatic pressure and the increased flow of blood in the radial artery; and

(e) attaining hemostasis of the radial artery;

wherein step (a) precedes all other steps, step (b) precedes step (c), and the ulnar pressure is applied for only a part of the duration of time.

2. The method of claim 1, wherein the dose of anticoagulant in step (a) 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 anticoagulant in step (a) 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 anticoagulant in step (a) is an equivalent of about 25 units of unfractionated heparin per kg of body weight.

5. The method of claim 1, wherein the dose of anticoagulant in step (a) is less than an equivalent of 25 units of unfractionated heparin per kg of body weight.

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

7. The method of claim 1, wherein the duration of time in step (c) is less than 60 minutes.

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

9. The method of claim 1, wherein the hemostatic pressure and the ulnar pressure are applied using a band wherein at least a first inflatable bladder applies the hemostatic pressure and at least a second inflatable bladder applies the ulnar pressure.

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

11. The method of claim 1, wherein applying the ulnar pressure to the ulnar artery comprises:

providing a band having an inflatable bladder, securing the band over a wrist such that the bladder contacts the ulnar pressure site, and inflating the bladder to compress the ulnar artery at the ulnar pressure site.

12. The method of claim 1, wherein the hemostatic pressure is applied using a first band comprising at least a first inflatable bladder, the first inflatable bladder applying the hemostatic pressure, and the ulnar pressure is applied using a technique selected from a group consisting of (i) a second band comprising at least a second inflatable bladder, wherein the second bladder applies the ulnar pressure, (ii) a mechanical device applies a compressing force at the ulnar pressure site;

(iii) manual pressure is applied at the ulnar pressure site.

13. The method of claim 1, wherein step (a) comprises administering anticoagulant at any time after introduction of a catheter or an introducer sheath and before removal of the catheter or the introducer sheath.

14. The method of claim 1, wherein step (a) comprises administering unfractionated heparin anticoagulant at any time before introduction of a catheter and/or an introducer sheath.

15. The method of claim 1, where 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.

25. The method of claim 13, wherein step (a) comprises administering unfractionated heparin at any time after introduction of a catheter or an introducer sheath and before removal of the catheter or the introducer sheath.

16. A method of obtaining hemostasis of a radial artery of a patient when performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:

(a) administering a dose of unfractionated heparin to the patient during the catheterization procedure, wherein the dose of unfractionated heparin is less than 50 units per kg of body weight;

(b) applying an ulnar pressure to an ulnar artery at an ulnar pressure site;

(c) applying a hemostatic pressure to the radial artery at the access site for a duration of time at least until hemostasis of the radial artery;

(d) attaining hemostasis of the radial artery; and

wherein step (a) precedes all other steps;

step (b) precedes step (c); and

the ulnar pressure is applied for only a part of the duration of time.

17. The method of claim 16, wherein the dose of unfractionated heparin in step (a) is in a range from about 15 units per kg of body weight to about 30 units per kg of body weight.

18. The method of claim 16, wherein the dose of unfractionated heparin in step (a) is in a range from about 20 units per kg of body weight to about 40 units per kg of body weight.

19. The method of claim 16, wherein the dose of unfractionated heparin in step (a) is about 25 units per kg of body weight.

20. The method of claim 16, wherein the dose of unfractionated heparin in step (a) is less than 25 units per kg of body weight.

21. The method of claim 16, wherein the duration of time in step (c) is less than 60 minutes.

22. The method of claim 16, wherein the duration of time in step (c) is about 60 minutes.

23. The method of claim 16, wherein the hemostatic pressure is applied using a band comprising at least one inflatable bladder, wherein the bladder applies the hemostatic pressure.

24. The method of claim 23, wherein the ulnar pressure in step (b) is applied using a technique selected from a group consisting of (i) a second band comprising at least a second inflatable bladder, wherein the second bladder applies the ulnar pressure, (ii) a mechanical device applies a compressing force at the ulnar pressure site;

(iii) manual pressure is applied at the ulnar pressure site.

26. The method of claim 16, wherein step (a) comprises administering unfractionated heparin at any time before introduction of a catheter and/or an introducer sheath.

27. The method of claim 16, wherein the duration of time in step (c) is less than 120 minutes.

28. The method of claim 16, wherein applying the ulnar pressure to the ulnar artery in step (b) compresses the ulnar artery partially or fully.

29. The method of claim 16, wherein the ulnar pressure in step (b) is applied intermittently.

30. The method of claim 16, wherein the ulnar pressure in step (b) is applied continuously.