IP Library Granted Patent US 11,350,943
Granted Patent B2
US 11,350,943 · App. 16/829,317 · Granted Jun 7, 2022

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

Inventor: Samir Bipin Pancholy (Clarks Summit, PA)
Assignee: Vasoinnovations Inc.
A61B17/12A61B17/12009A61B17/135A61B17/1325A61B2017/12004
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Quick Facts
Patent No.
US 11,350,943
App. No.
16/829,317
Granted
Jun 7, 2022
Kind
B2
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 (26)

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, and maintaining simultaneously the hemostatic pressure to the radial artery and the ulnar pressure to the ulnar artery;

(d) releasing the ulnar pressure whereby the ulnar pressure is applied for only a part of the duration of time; and

(e) attaining hemostasis of the radial artery;

wherein step (a) precedes all other steps, step (d) precedes step (e), the hemostatic pressure to the radial artery in step (b) is gradually reduced after about 60 minutes of hemostatic compression of the radial artery at the access site.

2. The method of claim 1 , further comprising a step of monitoring and/or confirming patency of the radial artery, the step of monitoring and/or confirming patency of the radial artery being 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 2 , 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 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 ulnar pressure site is a Guyon's canal.

7. 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.

8. 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.

9. 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.

10. 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.

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

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

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

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

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.

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

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

18. 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.

19. 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.

20. 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.

Assignments (1)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Oct 12, 2020
From: PANCHOLY, SAMIR BIPIN, DR
To: VASOINNOVATIONS INC
Reel/Frame 054031/0498 →
Continuity (7)
Continuation 15924273 · Mar 18, 2018
Continuation 15426056 · Feb 7, 2017
Continuation In Part 15340023 · Nov 1, 2016
Continuation 15062150 · Mar 6, 2016
Continuation 13941219 · Jul 12, 2013
Provisional Application 62405951 · Oct 9, 2016
Related Publication 20200222052A1 · Jul 16, 2020
Cited By (1)
US 12,733,935