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

• US 10,639,042 B2
• Filed: 03/18/2018
• Issued: 05/05/2020
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: Pancholy, Samir Bipin
• Primary Examiner(s): Severson, Ryan J.
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US15/924,273
• Publication Number:
  US 20180206847A1
• Time in Patent Office: 779 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 to attain patent hemostasis of a radial artery during a catheterization procedure involving the radial artery that is punctured at an access site, comprising:

(a) increasing a flow of blood in the radial artery;

(b) administering an anticoagulant, wherein a dosage of the anticoagulant is less than an equivalent of 50 units of unfractionated heparin per kg of body weight;

(c) applying hemostatic pressure to the access site; and

(d) attaining patent hemostasis of the radial artery.

2. The method of claim 1, further comprising administering the anticoagulant at any time before introduction of a catheter or an introducer sheath.

3. The method of claim 1, wherein the anticoagulant is selected from a group consisting of heparin, dalteparin, danaparoid, enoxaparin, unfractionated heparin, other low molecular weight heparin, direct thrombin inhibitors including hirudin, argatroban, bivalirudin and all substances derived from and/or related to the foregoing substances.

4. The method of claim 1, further comprising 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.

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

6. The method of claim 1, wherein the dosage of the anticoagulant is an equivalent of about 25 units of unfractionated heparin per kg of body weight.

7. The method of claim 1, wherein the dosage of the anticoagulant is in a range equivalent of 20-40 units of unfractionated heparin per kg of body weight.

8. The method of claim 1, wherein the dosage of the anticoagulant is in a range equivalent of 15-30 units of unfractionated heparin per kg of body weight.

9. The method of claim 1, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site for a duration of time less than 120 minutes.

10. The method of claim 1, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site for a duration of time of about 60 minutes.

11. The method of claim 1, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site for a duration of time less than 60 minutes.

12. The method of claim 1, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site for a hemostatic compression time of less than 120 minutes, and by increasing the flow of blood in the radial artery by simultaneously compressing an ipsilateral ulnar artery (a) continuously for entirety of the hemostatic compression time, (b) continuously for a part of the hemostatic compression time, or (c) intermittently during the hemostatic compression time.

13. The method of claim 12, wherein the ipsilateral ulnar artery is compressed fully or partially.

14. The method of claim 1, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site by using a band having at least two inflatable bladders, wherein at least a first inflatable bladder is used to apply the hemostatic pressure to the access site and at least a second inflatable bladder is used to increase the flow of blood in the radial artery by applying an ulnar pressure at an ulnar pressure site.

15. The method of claim 1, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site by using a first band comprising at least one inflatable bladder, wherein the at least one inflatable bladder of the first band applies the hemostatic pressure to the access site, and by increasing the flow of blood in the radial artery by applying an ulnar pressure using a technique selected from a group consisting of (i) a second band comprising at least one inflatable bladder, wherein the at least one inflatable bladder of the second band applies a pressure at an ulnar pressure site, (ii) a mechanical device applies a compressing force at the ulnar pressure site;

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

16. A method to attain patent hemostasis of a radial artery during a catheterization procedure involving the radial artery that is punctured at an access site, comprising:

(a) increasing a flow of blood in the radial artery;

(b) administering an anticoagulant at a dosage that is less than an equivalent of 50 units of unfractionated heparin per kg of body weight, wherein the anticoagulant is selected from a group consisting of heparin, dalteparin, danaparoid, enoxaparin, unfractionated heparin, other low molecular weight heparin, direct thrombin inhibitors including hirudin, argatroban, bivalirudin and all substances derived from and/or related to the foregoing substances;

(c) applying hemostatic pressure to the access site; and

(d) attaining patent hemostasis of the radial artery.

17. The method of claim 16, wherein patent hemostasis of the radial artery is attained at the access site by applying the hemostatic pressure to the access site by using a band having at least two inflatable bladders wherein at least a first inflatable bladder is used to apply the hemostatic pressure to the access site for a duration of time and at least a second inflatable bladder is used to increase the flow of blood in the radial artery by applying a compressive pressure on an ipsilateral ulnar artery at an ulnar pressure site.

18. The method of claim 17, wherein the duration of time is less than 120 minutes.

19. The method of claim 17, wherein the compressive pressure on the ipsilateral ulnar artery is applied (a) continuously for the entirety of the duration of time, (b) continuously for a part of the duration of time, or (c) intermittently during the duration of time.

20. A method to attain patent hemostasis of a radial artery during a catheterization procedure involving the radial artery that is punctured at an access site, comprising:

(a) increasing a flow of blood in the radial artery;

(b) administering an anticoagulant at a dosage that is an equivalent of about 25 units of unfractionated heparin per kg of body weight;

(c) applying hemostatic pressure to the access site; and

(d) attaining patent hemostasis of the radial artery.

21. The method of claim 20, wherein the step of applying the hemostatic pressure to the access site is performed for a duration of time less than 120 minutes.