Apparatus and method to stop bleeding

• US 10,507,026 B2
• Filed: 09/13/2018
• Issued: 12/17/2019
• 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): Woo, Julian W
• Application Number:
  US16/130,959
• Publication Number:
  US 20190008523A1
• Time in Patent Office: 460 Days
• Field of Search: 606201-203, 606204, 601132, 601151, 601 33, 601 40, 602 57
• 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 obtaining hemostasis at a puncture site of a radial artery on a wrist of a patient comprising:

a) applying a hemostatic device to the wrist of the patient so that a flexible band of the hemostatic device is wrapped around at least a portion of the wrist, wherein a member of the hemostatic device being more rigid than the flexible band possesses an inner peripheral surface facing the wrist, at least a first balloon of the hemostatic device is positioned between the wrist and the member, and wherein applying the hemostatic device to the wrist of the patient occurs while the at least first balloon is in an uninflated state;

b) positioning the at least first balloon relative to the puncture site such that the at least first balloon overlies the puncture site and is deviated to a center portion of the member from an end of the member in a lengthwise direction of the flexible band;

c) inflating the at least first balloon while the at least first balloon overlies the puncture site of the radial artery so that the at least first balloon, while inflated, applies a radial compressive force directly against the puncture site, whereby when a palmar aspect of the wrist is substantially parallel to a horizontal plane, the radial compressive force in totality has a direction oblique to the horizontal plane pointing away from a center portion of the wrist and pointing in an outward direction, whereby a component of the radial compressive force will not affect an ulnar artery for a purpose of avoiding an impact at a location of the ulnar artery; and

d) maintaining inflation of the at least first balloon and the compressive force against the puncture site for a duration of time at least until hemostasis of the radial artery.

2. The method of claim 1, further comprising positioning at least a second balloon of the hemostatic device at an ulnar pressure site on an ipsilateral ulnar artery and inflating the at least second balloon so that the at least second balloon, while inflated, applies an ulnar compressive force on the ulnar artery.

3. The method of claim 2, wherein applying the ulnar compressive force to the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery fully.

4. The method of claim 2, wherein applying the ulnar compressive force to the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery partially.

5. The method of claim 2, wherein the ulnar pressure site is a Guyon'"'"'s canal.

6. The method of claim 2, further comprising monitoring patency of the radial artery.

7. The method of claim 2, further comprising adjusting simultaneously and independently the ulnar compressive force on the ulnar artery and the radial compressive force on the radial artery, thereby optimizing the radial compressive force by which bleeding from the radial artery stops while simultaneously applying the ulnar compressive force on the ulnar artery to reduce incidence of occlusion of the radial artery.

8. The method of claim 2, wherein the member is a curved frame, said curved frame being bendable whereby the curved frame does not maintain a substantially fixed shape.

9. The method of claim 2, further comprising maintaining the ulnar compressive force on the ulnar artery at least until hemostasis of the radial artery is obtained.

10. The method of claim 2, further comprising maintaining the ulnar compressive force on the ulnar artery for a period of time less than the duration of time for hemostasis, wherein the ulnar compressive force is reduced to zero before hemostasis of the radial artery is obtained.

11. A method directed at obtaining hemostasis at a puncture site of a radial artery on a wrist of a patient comprising:

i. applying a hemostatic device to the wrist of the patient so that a flexible band of the hemostatic device is wrapped around at least a portion of the wrist, a curved portion and a flat portion being provided on the flexible band so that when the hemostatic device is applied to the wrist of the patient a curved inner side of the curved portion and a flat inner side of the flat portion face the wrist of the patient;

ii. placing the flat inner side of the flat portion in congruence with a substantially flat outer side of the wrist and placing the curved inner side of the curved portion in congruence with a substantially curved outer side of the wrist, and positioning at least a first balloon of the hemostatic device to overlie the puncture site, wherein the at least first balloon is deviated to a center portion of the flat inner side from the curved inner side in a lengthwise direction of the flexible band;

iii. inflating the at least first balloon while the at least first balloon overlies the puncture site so that the at least first balloon, while inflated, applies a radial compressive force directly to the puncture site on a surface of the patient'"'"'s wrist, whereby when a palmar aspect of the wrist is substantially parallel to a horizontal plane, the radial compressive force in totality has a direction oblique to the horizontal plane pointing away from a center portion of the wrist and pointing in an outward direction, whereby a component of the radial compressive force will not affect an ulnar artery for a purpose of avoiding an impact at a location of the ulnar artery; and

iv. maintaining inflation of the at least first balloon and the radial compressive force against the puncture site to obtain hemostasis of the radial artery.

12. The method of claim 11, further comprising positioning at least a second balloon of the hemostatic device at an ulnar pressure site on an ipsilateral ulnar artery and inflating the at least second balloon so that the at least second balloon, while inflated, applies an ulnar compressive force on the ulnar artery.

13. The method of claim 12, wherein applying the ulnar compressive force to the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery fully.

14. The method of claim 12, wherein applying the ulnar compressive force to the ulnar artery at the ulnar pressure site comprises compressing the ulnar artery partially.

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.

17. The method of claim 12, further comprising adjusting simultaneously and independently the ulnar compressive force to the ulnar artery and the radial compressive force to the radial artery, thereby optimizing the radial compressive force by which bleeding from the radial artery stops while simultaneously applying the ulnar compressive force to the ulnar artery to reduce incidence of occlusion of the radial artery.

18. The method of claim 12, wherein a surface of the at least first balloon comprises a coating and a peel-off laminate, said coating comprising an oil, the peel-off laminate being removed before placing the at least first balloon on the puncture site.

19. The method of claim 12, further comprising maintaining the ulnar compressive force on the ulnar artery at least until hemostasis of the radial artery is obtained.

20. The method of claim 12, further comprising maintaining the ulnar compressive force on the ulnar artery for a period of time less than a duration of time for hemostasis, wherein the ulnar compressive force is reduced to zero before hemostasis of the radial artery is obtained.