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

• US 10,342,551 B2
• Filed: 09/18/2017
• Issued: 07/09/2019
• 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:
  US15/708,123
• Publication Number:
  US 20180000495A1
• Time in Patent Office: 659 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 patent 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) applying an ulnar pressure on an ulnar artery at an ulnar pressure site by compressing the ulnar artery at least partially for a purpose of attaining patent hemostasis of the radial artery;

(b) applying a radial pressure on the radial artery at the access site to stop bleeding at the access site;

(c) continuing to apply the radial pressure on the radial artery for a duration of time to attain patent hemostasis of the radial artery;

(d) continuing to apply the ulnar pressure on the ulnar artery at the ulnar pressure site to compress the ulnar artery at least partially for a first period of time for the purpose of attaining patent hemostasis of the radial artery, wherein the first period of time is at least several minutes;

(e) attaining patent hemostasis of the radial artery;

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 patent hemostasis of the radial artery is attained.

2. The method of claim 1, wherein the ulnar pressure is applied by inflating at least a first bladder and the radial pressure is applied by inflating at least a second bladder.

3. The method of claim 2, wherein the first bladder and the second bladder are connected to a band.

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

5. The method of claim 1, further comprising a step of monitoring patency of the radial artery by sensing skin blood flow and/or pulsation at a fingertip and/or pulsation at a location downstream of the access site.

6. The method of claim 1, wherein the step (a) of applying the ulnar pressure to the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery fully, thereby allowing no flow through the ulnar artery.

7. The method of claim 1, wherein step (b) precedes step (a).

8. The method of claim 1, wherein the duration of time is less than 120 minutes.

9. The method of claim 1, further comprising administering a dose of an anticoagulant to the patient during the catheterization procedure wherein the dose of the anticoagulant is in a range from an equivalent of about 15 units of unfractionated heparin per kg of body weight to an equivalent of about 40 units of unfractionated heparin per kg of body weight.

10. The method of claim 9, wherein the anticoagulant is selected from the 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.

11. The method of claim 1, wherein the radial pressure is applied using a first band comprising at least one inflatable bladder and the ulnar pressure is applied using a technique selected from a group consisting of (i) a second band comprising at least one inflatable bladder, wherein the inflatable bladder of the second band applies the ulnar pressure at the 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.

12. A method of attaining patent 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) applying an ulnar pressure on an ulnar artery at an ulnar pressure site by compressing the ulnar artery at least partially for a purpose of attaining patent hemostasis of the radial artery;

(b) applying a radial pressure on the radial artery at the access site to stop bleeding at the access site;

(c) continuing to apply the radial pressure on the radial artery for a duration of time to attain patent hemostasis of the radial artery;

(d) continuing to apply the ulnar pressure on the ulnar artery at the ulnar pressure site to compress the ulnar artery at least partially for a first period of time for the purpose of attaining patent hemostasis of the radial artery, wherein the first period of time is at least several minutes;

(e) reducing the ulnar pressure to zero during a second period of time before attaining patent hemostasis of the radial artery;

(f) attaining patent hemostasis of the radial artery;

wherein the ulnar pressure is not applied on the ulnar artery for a third period of time up until and including the moment in which patent hemostasis of the radial artery is attained.

13. The method of claim 12, wherein the ulnar pressure is applied by inflating at least a first bladder and the radial pressure is applied by inflating at least a second bladder.

14. The method of claim 13, wherein the first bladder and the second bladder are connected to a band.

15. The method of claim 12, wherein the ulnar pressure site is a Guyon'"'"'s canal.

16. The method of claim 12, further comprising a step of monitoring patency of the radial artery by sensing skin blood flow and/or pulsation at a fingertip and/or pulsation at a location downstream of the access site.

17. The method of claim 12, wherein the step (a) of applying the ulnar pressure to the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery fully thereby allowing no flow through the ulnar artery.

18. The method of claim 12, wherein step (b) precedes step (a).

19. The method of claim 12, wherein the duration of time is less than 120 minutes.

20. The method of claim 12, further comprising administering a dose of an anticoagulant to the patient during the catheterization procedure wherein the dose of the anticoagulant is in a range from an equivalent of about 15 units of unfractionated heparin per kg of body weight to an equivalent of about 40 units of unfractionated heparin per kg of body weight.

21. The method of claim 20, 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.

22. The method of claim 12, wherein the radial pressure is applied using a first band comprising at least one inflatable bladder and the ulnar pressure is applied using a technique selected from a group consisting of (i) a second band comprising at least one inflatable bladder, wherein the inflatable bladder of the second band applies the ulnar pressure at the 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.