METHOD TO STOP BLEEDING, WITH SHORT HEMOSTASIS DURATION USING A LOW DOSE OF ANTICOAGULANT

• US 20180206847A1
• Filed: 03/18/2018
• Published: 07/26/2018
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: PANCHOLY, SAMIR BIPIN
• Granted Patent: US 10,639,042 B2
• Time in Patent Office: Days
• 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 a hemostatic pressure to the radial artery at the access site for a duration of time at least until hemostasis of the radial artery;

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

(d) maintaining simultaneously the hemostatic pressure to the radial artery and the ulnar pressure to the ulnar artery;

(e) monitoring and/or confirming patency of the radial artery; and

(f) attaining hemostasis of the radial artery;

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

2. The method of claim 1, wherein the step of monitoring and/or confirming patency of the radial artery is performed by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site.

3. The method of claim 2, wherein the sensing is performed while the ulnar artery is fully compressed or partially compressed.

4. The method of claim 1, wherein the step of confirming patency includes the use of digital plethysmography.

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

6. 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.

7. The method of claim 1, wherein performing the catheterization procedure comprises using a sheath to access the radial artery and applying the ulnar pressure to the ulnar artery while the sheath remains inserted in the radial artery.

8. 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.

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

10. The method of claim 1, wherein applying the ulnar pressure to the ulnar artery in step (c) compresses the ulnar artery partially or fully.

11. The method of claim 1, wherein the ulnar pressure in step (c) is applied intermittently.

12. The method of claim 1, wherein the ulnar pressure in step (c) is applied continuously.

13. 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.

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

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

16. The method of claim 1, wherein the dose of anticoagulant in step (a) is less than an equivalent of 50 units of unfractionated heparin per kg of body weight.

17. 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.

18. 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.

19. 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.

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

21. 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 a hemostatic pressure to the radial artery at the access site for a duration of time at least until hemostasis of the radial artery;

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

(d) maintaining simultaneously the hemostatic pressure to the radial artery and the ulnar pressure to the ulnar artery;

(e) monitoring and/or confirming patency of the radial artery; and

(f) attaining hemostasis of the radial artery;

wherein step (a) precedes all other steps, the ulnar pressure is applied for only a part of the duration of time, and the hemostatic pressure is gradually reduced and weaned off from the access site.

22. 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 a hemostatic pressure to the radial artery at the access site for a duration of time at least until hemostasis of the radial artery;

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

(d) maintaining simultaneously the hemostatic pressure to the radial artery and the ulnar pressure to the ulnar artery;

(e) monitoring and/or confirming patency of the radial artery; and

(f) attaining hemostasis of the radial artery;

wherein

step (a) precedes all other steps;

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

the dose of anticoagulant in step (a) is less than an equivalent of 50 units of unfractionated heparin per kg of body weight;

the duration of time in step (b) is less than 120 minutes;

the step of monitoring and/or confirming patency of the radial artery is performed by sensing skin blood flow and/or pulsation at a finger-tip or other location downstream of the access site; and

the sensing is performed while the ulnar artery is fully compressed or partially compressed.