Apparatus and method to stop bleeding

• US 10,335,161 B2
• Filed: 05/05/2017
• Issued: 07/02/2019
• 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): Yabut, Diane D
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US15/588,586
• Publication Number:
  US 20170238939A1
• Time in Patent Office: 788 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 17/3215 Packages or dispensers for scalpel blades for sharps A61B50/3001
• CPC Class Codes: A61B 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00902 transparent or translucent
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• 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

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 bleeding from a first artery is stopped by compressing the first artery at the puncture site using inflation of the first balloon and the blood flow in the first artery is increased by compression of a second artery using inflation of the second balloon.

Claims

1. A method directed at attaining hemostasis of a radial artery of a patient after performing a catheterization procedure at an access site of the radial artery, comprising performing the following steps:

(a) applying a first pressure on an ulnar artery at an ulnar pressure site by inflating at least a first balloon for a purpose of reducing risk of post-instrumentation radial artery occlusion;

(b) applying a second pressure on the radial artery by inflating at least a second balloon at the access site to stop bleeding at the access site;

(c) continuing to apply the second pressure on the radial artery to attain hemostasis of the radial artery;

(d) continuing to apply the first pressure simultaneously on the ulnar artery for the purpose of reducing risk of post-instrumentation radial artery occlusion;

(e) reducing the first pressure on the ulnar artery to zero before attaining hemostasis of the radial artery, whereby the first pressure is not applied up until and including the moment in which hemostasis of the radial artery is attained;

(f) attaining hemostasis of the radial artery.

2. The method of claim 1, wherein at least the first balloon and at least the second balloon are connected to a band.

3. The method of claim 2, wherein the band is flexible and comprises:

a curved portion possessing an inner side that faces towards a wrist of the patient wherein the band is applied to the wrist of the patient, the curved portion being curved by virtue of the inner side of the curved portion being a curved inner side;

a flat portion possessing an inner side that faces towards the wrist of the patient when the band is applied to the wrist of the patient, the flat portion being flat by virtue of the inner side of the flat portion being a flat inner side;

the curved portion and the flat portion being provided on the band so that, when the band is applied to the wrist of the patient the curved inner side of the curved portion and the flat inner side of the flat portion face the wrist of the patient; and

the second balloon applying a compressive force to the access site on a surface of patient'"'"'s wrist, the compressive force in totality being in an oblique direction with respect to the surface of the wrist.

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

5. The method of claim 1, wherein the step of reducing the first pressure to zero comprises gradually reducing the first pressure to zero.

6. The method of claim 1, further comprising 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.

7. The method of claim 6, wherein the step of monitoring patency is performed while the ulnar artery is fully compressed or partially compressed.

8. The method of claim 6, further comprising confirming patency of the radial artery while applying pressure on the radial artery to attain hemostasis at the access site.

9. The method of claim 1, wherein steps (c) and (d) comprise adjusting the first pressure on the ulnar artery and the second pressure on the radial artery, thereby optimizing the second pressure at which bleeding from the radial artery stops while simultaneously applying the first pressure on the ulnar artery to reduce incidence of occlusion of the radial artery.

10. The method of claim 1, wherein the step of applying the first pressure on the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery fully thereby allowing no flow through the ulnar artery.

11. The method of claim 1, wherein the step of applying the first pressure on the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery partially thereby allowing less flow through the ulnar artery than when the ulnar artery is not compressed.

12. A method directed at attaining hemostasis of a radial artery of a patient after performing a catheterization procedure at an access site of the radial artery, comprising the steps of:

(i) placing at least a first balloon on an ulnar artery at an ulnar pressure site;

(ii) placing at least a second balloon at the access site on the radial artery where bleeding is to be stopped;

(iii) applying a radial pressure on the radial artery at the access site by inflating at least the second balloon;

(iv) applying an ulnar pressure on the ulnar artery at the ulnar pressure site by inflating at least the first balloon for a purpose of reducing risk of post-instrumentation radial artery occlusion;

(v) continuing to apply the radial pressure on the radial artery at the access site for a duration of time to attain hemostasis of the radial artery;

(vi) continuing to apply the ulnar pressure simultaneously on the ulnar artery at the ulnar pressure site for the purpose of reducing risk of post-instrumentation radial artery occlusion;

(vii) attaining hemostasis of the radial artery, wherein step (iii) precedes step (iv) and the radial pressure is applied while a sheath or a catheter remains inserted in the radial artery or after the sheath or the catheter is removed from the radial artery; and

wherein step (vi) comprises reducing the ulnar pressure on the ulnar artery to zero before attaining hemostasis of the radial artery, whereby the ulnar pressure is not applied up until and including the moment in which hemostasis of the radial artery is attained.

13. The method of claim 12, wherein at least the first balloon and at least the second balloon are connected to a band.

14. The method of claim 13, wherein the band is flexible and comprises:

a curved portion possessing an inner side that faces towards a wrist of the patient wherein the band is applied to the wrist of the patient, the curved portion being curved by virtue of the inner side of the curved portion being a curved inner side;

a flat portion possessing an inner side that faces towards the wrist of the patient when the band is applied to the wrist of the patient, the flat portion being flat by virtue of the inner side of the flat portion being a flat inner side;

the curved portion and the flat portion being provided on the band so that when the band is applied to the wrist of the patient the curved inner side of the curved portion and the flat inner side of the flat portion face the wrist of the patient; and

the second balloon applying a compressive force to the access site on a surface of patient'"'"'s wrist, the compressive force in totality being in an oblique direction with respect to the surface of the wrist.

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

16. The method of claim 12, further comprising 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 16, wherein the step of monitoring patency is performed while the ulnar artery is fully compressed or partially compressed.

18. The method of claim 16, further comprising confirming patency of the radial artery while applying pressure on the radial artery to attain hemostasis at the access site.

19. The method of claim 12, wherein reducing the ulnar pressure on the ulnar artery to zero comprises gradually reducing the ulnar pressure to zero.

20. A method directed at attaining hemostasis of a radial artery after performing a catheterization procedure using a sheath at an access site of the radial artery on a wrist of a patient, comprising performing the following steps:

(a) applying a first pressure on an ulnar artery at an ulnar pressure site by inflating at least a first balloon to compress the ulnar artery while the sheath remains inserted in the radial artery for a purpose of reducing risk of post-instrumentation radial artery occlusion;

(b) removing the sheath from the radial artery while maintaining the first pressure on the ulnar artery;

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

(d) continuing to apply the first pressure on the ulnar artery for the purpose of reducing risk of post-instrumentation radial artery occlusion;

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

(f) reducing the first pressure on the ulnar artery to zero before attaining hemostasis of the radial artery, whereby the first pressure is not applied up until and including the moment in which hemostasis of the radial artery is attained;

(g) attaining hemostasis of the radial artery, wherein step (a) precedes step (c).

21. The method of claim 20, wherein the step (d) of continuing to apply the first pressure on the ulnar artery comprises applying the first pressure to fully and/or partially compress the ulnar artery.

22. The method of claim 20, further comprising at least a vasodilator medication being disposed on at least a portion of a skin-contacting surface of the second balloon pressing on the access site.

23. The method of claim 20, wherein reducing the first pressure to zero comprises gradually reducing the first pressure to zero.

24. The method of claim 20, wherein the step (c) of applying the second pressure on the radial artery is accomplished while maintaining the first pressure on the ulnar artery.

25. The method of claim 20, wherein the ulnar pressure site is a Guyon'"'"'s canal.

26. The method of claim 20, further comprising 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.

27. The method of claim 26, further comprising confirming patency of the radial artery while applying pressure on the radial artery to attain hemostasis at the access site.

28. The method of claim 20, wherein at least the first balloon and at least the second balloon are connected to a band.

29. The method of claim 28, wherein the band is flexible and comprises:

a curved portion possessing an inner side that faces towards the wrist of the patient wherein the band is applied to the wrist of the patient, the curved portion being curved by virtue of the inner side of the curved portion being a curved inner side;

a flat portion possessing an inner side that faces towards the wrist of the patient when the band is applied to the wrist of the patient, the flat portion being flat by virtue of the inner side of the flat portion being a flat inner side;

the curved portion and the flat portion being provided on the band so that when the band is applied to the wrist of the patient the curved inner side of the curved portion and the flat inner side of the flat portion face the wrist of the patient; and

the second balloon applying a compressive force to the access site on a surface of patient'"'"'s wrist, the compressive force in totality being in an oblique direction with respect to the surface of the wrist.

30. The method of claim 20, wherein steps (d) and (e) comprise adjusting the first pressure on the ulnar artery and the second pressure on the radial artery, thereby optimizing the second pressure at which bleeding from the radial artery stops while simultaneously applying the first pressure on the ulnar artery to reduce incidence of occlusion of the radial artery.