Apparatus and method to stop bleeding

• US 9,642,628 B2
• Filed: 04/15/2016
• Issued: 05/09/2017
• Est. Priority Date: 07/12/2013
• Status: Active Grant

• Current Assignee: VasoInnovations, Inc.
• Original Assignee: VasoInnovations, Inc.
• Inventors: Pancholy, Samir Bipin, Sardesai, Nolan Rajendra, Panse, Milind Padmakar, Sardesai, Rajendra Gurudas
• Primary Examiner(s): Holwerda, Kathleen
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US15/099,603
• Publication Number:
  US 20170035438A1
• Time in Patent Office: 389 Days
• Field of Search: 606201-203, 601132, 601151, 601 33, 601 40
• 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 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/00951 adhesive
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• CPC Class Codes: A61B 5/0295 using plethysmography, i.e. measuring the variations in the volume of a body part as modified by the circulation of blood therethrough, e.g. impedance plethysmography
• CPC Class Codes: A61B 90/92 coded with colour
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10185 Valves

Abstract

A hemostatic device is provided to stop bleeding at a puncture site on the wrist of a patient, the device comprising a transparent flexible band to be wrapped at the site where the bleeding is to be stopped, a curved frame having an inner peripheral side and possessing a first curved portion in its first half and a second curved portion in its second half, a first balloon provided on the inner peripheral side in the first half of the curved frame and a second balloon provided on the inner peripheral side in the second half of the curved frame, the first balloon being larger than the second balloon. The bleeding from radial artery is stopped by compressing the radial artery at the puncture site using inflation of the first balloon and radial artery flow is increased by compression of ipsilateral ulnar artery using inflation of the second balloon.

Claims

1. A method directed at minimizing occurrences of occlusion of a radial artery after performing a catheterization procedure on a hand of a patient at an access site of the radial artery, comprising performing the following steps:

(a) wrapping and securing a band around the hand of the patient at the access site where bleeding is to be stopped, said band comprising a first balloon and a second balloon;

(b) continuously applying a first pressure to an ulnar artery at an ulnar pressure site by inflating the first balloon, wherein the first pressure only partially compresses the ulnar artery;

(c) applying a second pressure to the radial artery by inflating the second balloon at the access site;

(d) maintaining simultaneously the first pressure to the ulnar artery and the second pressure to the radial artery at least until hemostasis of the radial artery is achieved, wherein steps (b) and (c) precede step (d).

2. The method of claim 1 wherein step (d) further comprises manipulating simultaneously and independently the first pressure to the ulnar artery and the second pressure to the radial artery, thereby optimizing the second pressure at which bleeding from the radial artery stops while simultaneously applying the first pressure to the ulnar artery to minimize occlusion of the radial artery.

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

4. The method of claim 1, further comprising monitoring patency of the radial artery by sensing.

5. The method of claim 4, wherein the step of monitoring patency comprises performing sensing while the ulnar artery is partially compressed.

6. The method of claim 5, wherein the sensing is performed downstream of the access site.

7. The method of claim 5, wherein the sensing is performed upstream of the access site.

8. The method of claim 4, further comprising confirming patency of the radial artery while applying pressure to the radial artery to obtain hemostasis at the access site.

9. The method of claim 4, wherein the step of monitoring patency further comprises using digital plethysmography.

10. The method of claim 1 wherein applying the first pressure to the ulnar artery at the ulnar pressure site comprises the first pressure having a component in a vertical cross-sectional plane of the wrist.

11. The method of claim 1 wherein applying the second pressure to the radial artery comprises the second pressure acting in an outward direction away from a center portion of the wrist.

12. A method of catheterization of a radial artery of a patient, directed at minimizing occurrences of radial artery occlusion, comprising the steps of:

(i) inserting a sheath into the radial artery at an access site;

(ii) performing a catheterization procedure using the sheath to access the radial artery;

(iii) placing a radial balloon at the access site where bleeding is to be stopped;

(iv) placing an ulnar balloon on an ulnar artery at an ulnar pressure site;

(v) applying a radial pressure to the radial artery at the access site by inflating the radial balloon while continuously applying an ulnar pressure to the ulnar artery at the ulnar pressure site by inflating the ulnar balloon, wherein the ulnar pressure only partially compresses the ulnar artery;

(vi) continuing to simultaneously apply the ulnar pressure to the ulnar artery at the ulnar pressure site and the radial pressure to the radial artery at the access site at least until hemostasis of the radial artery is achieved.

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

14. The method of claim 12, further comprising monitoring patency of the radial artery by sensing.

15. The method of claim 14, wherein the step of monitoring patency comprises performing sensing while the ulnar artery is partially compressed.

16. The method of claim 15, wherein the sensing is performed downstream of the access site.

17. The method of claim 15, wherein the sensing is performed upstream of the access site.

18. The method of claim 14, further comprising confirming patency of the radial artery while applying pressure to the radial artery to obtain hemostasis at the access site.

19. The method of claim 14, wherein the step of monitoring patency further comprises using digital plethysmography.

20. The method of claim 12, wherein partially applying the ulnar pressure to the ulnar artery at the ulnar pressure site thereby allows less flow through the ulnar artery than when the ulnar artery is not compressed at all.

21. The method of claim 12 wherein applying the radial pressure comprises the radial pressure not impacting the ulnar artery.

22. The method of claim 12 wherein applying the ulnar pressure comprises the ulnar pressure having a negligible component in a direction towards the radial artery.