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

• US 10,245,041 B2
• Filed: 09/20/2018
• Issued: 04/02/2019
• 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:
  US16/136,913
• Publication Number:
  US 20190015111A1
• Time in Patent Office: 194 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
• CPC Class Codes: A61K 31/727 Heparin; Heparan

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 attaining 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 an anticoagulant to the patient during the catheterization procedure;

(b) applying an ulnar pressure on an ulnar artery at an ulnar pressure site by inflating at least a first bladder to fully compress the ulnar artery;

(c) 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;

(d) 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;

(e) 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;

(f) continuing to apply the ulnar pressure on the ulnar artery at the ulnar pressure site to compress the ulnar artery partially for a second period of time;

(g) attaining hemostasis of the radial artery;

wherein step (a) precedes all other steps, step (e) precedes step (f), and 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, whereby the ulnar pressure is not applied on the ulnar artery for a third period of time up until and including the moment in which hemostasis of the radial artery is attained.

2. The method of claim 1, wherein the dose of the 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 the 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 the 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 the 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 (d) is less than 120 minutes.

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

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

9. 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.

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

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

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

13. 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.

14. The method of claim 1, wherein step (b) precedes step (c).

15. The method of claim 1, wherein an introducer sheath used in the catheterization procedure is removed after step (b).

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

17. A method of attaining 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 an anticoagulant to the patient during the catheterization procedure;

(b) applying an ulnar pressure on an ulnar artery at an ulnar pressure site by inflating at least a first bladder to compress the ulnar artery fully;

(c) 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;

(d) 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;

(e) 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;

(f) attaining hemostasis of the radial artery;

wherein step (a) precedes all other steps, and wherein the ulnar pressure is not applied on the ulnar artery for a second period of time up until and including the moment in which hemostasis of the radial artery is attained.

18. The method of claim 17, wherein the dose of the 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.

19. The method of claim 17, wherein the dose of the 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.

20. The method of claim 17, wherein the dose of the anticoagulant in step (a) is an equivalent of about 25 units of unfractionated heparin per kg of body weight.

21. The method of claim 17, wherein the dose of the anticoagulant in step (a) is less than an equivalent of 25 units of unfractionated heparin per kg of body weight.

22. The method of claim 17, wherein the duration of time in step (d) is less than 120 minutes.

23. The method of claim 17, wherein the duration of time in step (d) is about 60 minutes.

24. The method of claim 17, 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.

25. The method of claim 17, wherein the ulnar pressure site is a Guyon'"'"'s canal.

26. The method of claim 17, wherein step (a) comprises administering the anticoagulant at any time after introduction of a catheter or an introducer sheath and before removal of the catheter or the introducer sheath.

27. The method of claim 17, wherein step (a) comprises administering the anticoagulant at any time before introduction of a catheter or an introducer sheath.

28. The method of claim 17, 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.

29. The method of claim 17, wherein step (b) precedes step (c).

30. A method of attaining 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 an anticoagulant to the patient during the catheterization procedure;

(b) applying an ulnar pressure on an ulnar artery at an ulnar pressure site by inflating at least a first bladder to compress the ulnar artery fully;

(c) 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;

(d) 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;

(e) 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;

(f) continuing to apply the ulnar pressure on the ulnar artery at the ulnar pressure site to compress the ulnar artery partially for a second period of time;

(g) attaining hemostasis of the radial artery;

wherein;

(i) step (a) precedes all other steps;

(ii) step (b) precedes step (c);

(iii) 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, whereby the ulnar pressure is not applied on the ulnar artery for a third period of time before hemostasis of the radial artery;

(iv) the dose of the 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; and

(v) the ulnar pressure site is a Guyon'"'"'s canal.