Apparatus and method to stop bleeding

• US 10,349,951 B2
• Filed: 06/22/2017
• Issued: 07/16/2019
• 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:
  US15/630,920
• Publication Number:
  US 20170281195A1
• Time in Patent Office: 754 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 frame comprising:

(i) a plurality of rungs;

(ii) at least two beams holding said plurality of rungs;

said frame being a compression member in a hemostasis device comprising at least one radial balloon attached to a band, a portion of the band defining a frame holder, the frame holder holding the frame, the at least one radial balloon configured to compress a radial artery at a puncture site on a wrist to attain hemostasis, the at least one radial balloon positioned underneath a first half of the frame holder, wherein during operation, when the at least one radial balloon expands and compresses the puncture site to stop bleeding, the frame performs by keeping at least a portion of the band defining a second half of the frame holder pressing on at least a portion of a base of a palm of the wrist, thereby facilitating compression of an ulnar artery.

2. The frame of claim 1, further comprising curved solid pieces at proximal and distal ends of the frame, with the plurality of rungs being in a center portion of the frame.

3. The frame of claim 1, wherein the frame in operation does not maintain a substantially fixed shape and flexes with the at least one radial balloon as the at least one radial balloon expands and contracts with pressure.

4. The frame of claim 1, wherein the plurality of rungs are equidistant from each other along a length of the frame and have a spacing between the plurality of rungs of about 2 mm.

5. The frame of claim 1, wherein the plurality of rungs are staggered whereby some rungs are close to each other and some rungs are spread out.

6. The frame of claim 5, wherein a spacing between the plurality of rungs in a center portion of the frame is greater than a spacing between the plurality of rungs at proximal and distal ends of the frame.

7. The frame of claim 1, wherein at least a portion of the frame is curved toward an inner peripheral side of the frame.

8. The frame of claim 1, wherein the plurality of rungs and the at least two beams have shapes selected from a group consisting of circular, square, rectangular and elliptical shapes.

9. The frame of claim 1, wherein the plurality of rungs are circular and have a diameter of about 2 mm.

10. The frame of claim 1, wherein the at least two beams are circular and have a diameter of about 3 mm.

11. A frame comprising:

(i) a plurality of rungs;

(ii) at least two beams holding said plurality of rungs;

(iii) curved solid pieces at proximal and distal ends of the frame, with the plurality of rungs being in a center portion of the frame; and

said frame being configured for placement in a frame holder of a hemostasis device, the hemostasis device comprising at least one radial balloon to compress a radial artery at a puncture site on a wrist to attain hemostasis, the at least one radial balloon positioned underneath a first half of the frame holder, wherein during operation, when the at least one radial balloon expands and compresses the puncture site to stop bleeding, the frame performs by flexing whereby at least a portion of the band defining a second half of the frame holder remains pressing on at least a portion of a base of a palm of the wrist.

12. The frame of claim 11, wherein the frame in operation does not maintain a substantially fixed shape and flexes with the at least one radial balloon as the at least one radial balloon expands and contracts with pressure.

13. The frame of claim 11, wherein the frame is flexible and said plurality of rungs have a spacing, and increasing the spacing between the plurality of rungs makes the frame more flexible and decreasing the spacing makes the frame less flexible.

14. The frame of claim 11, wherein the plurality of rungs are equidistant from each other along a length of the frame and a spacing between the plurality of rungs is about 2 mm.

15. The frame of claim 11, wherein the plurality of rungs are staggered whereby some rungs are close to each other and some rungs are spread out.

16. The frame of claim 11, wherein the plurality of rungs and the at least two beams have shapes selected from a group consisting of circular, square, rectangular and elliptical shapes.

17. The frame of claim 11, wherein the plurality of rungs are circular and have a diameter of about 2 mm.

18. The frame of claim 11, wherein the at least two beams are circular and have a diameter of about 3 mm.

19. The frame of claim 11, wherein the curved solid pieces have a thickness of about 2 mm.

20. The frame of claim 11, wherein the proximal end of the frame has a radius of curvature identical to a radius of curvature at the distal end of the frame.

21. A curved frame compression member configured for placement in a curved frame holder of a flexible band, a portion of the flexible band defining the curved frame holder, the flexible band adapted to be wrapped around a wrist of a patient at a puncture site where bleeding is to be stopped using at least a radial balloon to compress on the puncture site, comprising:

(i) a plurality of rungs;

(ii) two beams holding said plurality of rungs;

(iii) curved solid pieces at proximal and distal ends of the curved frame, with the plurality of rungs being in a center portion of the curved frame; and

the radial balloon positioned underneath a first half of the curved frame holder, wherein during operation, when the radial balloon expands and compresses the puncture site to stop bleeding, the curved frame performs by flexing whereby at least a portion of the flexible band defining a second half of the curved frame holder remains in contact with at least a portion of the wrist, thereby facilitating compression of an ulnar artery.

22. The curved frame of claim 21, wherein the plurality of rungs are equidistant from each other along a length of the curved frame.

23. The curved frame of claim 22, wherein said plurality of rungs are circular and have a diameter of about 2 mm.

24. The curved frame of claim 23, wherein said plurality of rungs have a spacing between them of about 2 mm.

25. The curved frame of claim 24, wherein said beams are circular and have a diameter of about 3 mm.

26. The curved frame of claim 25, wherein the curved solid pieces have a thickness of about 2 mm.

27. The curved frame of claim 26, wherein the proximal end of the curved frame has a radius of curvature identical to a radius of curvature at the distal end of the curved frame.

28. The curved frame of claim 21, wherein the plurality of rungs are staggered whereby some rungs are close to each other and some rungs are spread out.

29. The curved frame of claim 21, wherein the plurality of rungs and the beams have shapes selected from a group consisting of circular, square, rectangular and elliptical shapes.

30. The curved frame of claim 21, wherein the curved frame is flexible and said plurality of rungs have a spacing, and increasing the spacing between the plurality of rungs makes the curved frame more flexible and decreasing the spacing makes the curved frame less flexible.