Apparatus and method to stop bleeding

• US 10,357,254 B2
• Filed: 08/06/2018
• Issued: 07/23/2019
• 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:
  US16/056,261
• Publication Number:
  US 20180344325A1
• Time in Patent Office: 351 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 curved frame configured for placement in a double layer construction defining a curved frame holder of a flexible band, said flexible band adapted to be wrapped around a wrist of a patient at a puncture site on a radial artery where bleeding is to be stopped using a first balloon to compress on the puncture site and a second balloon to compress on an ipsilateral ulnar artery, a first part of the curved frame overlapping the first balloon and a second part of the curved frame overlapping the second balloon, wherein the curved frame does not maintain a substantially fixed shape while a device comprising the flexible band and the curved frame is in operation applying ulnar and/or radial compression to a wrist during a hemostasis procedure, and wherein during operation the curved frame flexes with the balloons as the balloons expand and contract with pressure.

2. The curved frame of claim 1 further comprising:

(i) a plurality of rungs; and

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

3. The curved frame of claim 2, further comprising 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.

4. The curved frame of claim 3, wherein the plurality of rungs are equidistant from each other along a length of the curved frame and have a spacing between the plurality of rungs of about 2 mm.

5. The curved frame of claim 4, wherein the plurality of rungs are circular and have a diameter of about 2 mm.

6. The curved frame of claim 4, wherein the at least two beams are circular and have a diameter of about 3 mm.

7. The curved frame of claim 3, wherein at least a portion of the curved frame is curved toward an inner peripheral side of the curved frame.

8. The curved frame of claim 2, wherein the plurality of rungs are staggered whereby some rungs are close to each other and some rungs are spread out.

9. The curved frame of claim 8, wherein a spacing between the plurality of rungs in a center portion of the curved frame is greater than a spacing between the plurality of rungs at proximal and distal ends of the curved frame.

10. The curved frame of claim 2, 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.

11. A curved frame configured for placement in a double layer construction defining a curved frame holder of a flexible band, said flexible band adapted to be wrapped around a wrist of a patient at a puncture site on a radial artery where bleeding is to be stopped using at least a first balloon to compress on the puncture site and at least a second balloon to compress on an ipsilateral ulnar artery, a first part of the curved frame overlapping the at least first balloon and a second part of the curved frame overlapping the at least second balloon, comprising:

the curved frame being made of a material more rigid than the flexible band;

the curved frame not maintaining a substantially fixed shape while a device comprising the flexible band and the curved frame is in operation applying ulnar and/or radial compression to a wrist during a hemostasis procedure; and

the curved frame flexing with the at least first balloon and/or the at least second balloon during operation as the at least first balloon and the at least second balloon expand and contract with pressure, whereby in operation when the at least first balloon expands and compresses the puncture site on the radial artery to stop bleeding, the curved frame performs by keeping the flexible band pressing the wrist thereby facilitating compression of the ulnar artery while the at least second balloon expands.

12. The curved frame of claim 11 further comprising:

(i) a plurality of rungs; and

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

13. The curved frame of claim 12, further comprising 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.

14. The curved frame of claim 12, wherein the plurality of rungs are equidistant from each other along a length of the curved frame and have a spacing between the plurality of rungs of about 2 mm.

15. The curved frame of claim 12, wherein the plurality of rungs are staggered whereby some rungs are close to each other and some rungs are spread out.

16. The curved frame of claim 15, wherein a spacing between the plurality of rungs in a center portion of the curved frame is greater than a spacing between the plurality of rungs at proximal and distal ends of the curved frame.

17. The curved frame of claim 12, 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.

18. The curved frame of claim 12, wherein the plurality of rungs are circular and have a diameter of about 2 mm.

19. The curved frame of claim 12, wherein the at least two beams are circular and have a diameter of about 3 mm.

20. The curved frame of claim 11, wherein at least a portion of the curved frame is curved toward an inner peripheral side of the curved frame.

21. A curved frame configured for placement in a double layer construction defining a curved frame holder of a flexible band, said flexible band adapted to be wrapped around a wrist of a patient at a puncture site on a radial artery where bleeding is to be stopped using at least a first balloon to compress on the puncture site, the at least first balloon positioned underneath a first half of the curved frame holder, comprising:

the curved frame being made of a material more rigid than the flexible band;

the curved frame flexing with the at least first balloon as the at least first balloon expands and contracts with pressure; and

wherein in operation when the at least first balloon expands and compresses the puncture site to stop bleeding, the curved frame performs by keeping at least a portion of the flexible band defining a second half of the curved frame holder pressing on at least a portion of a base of a palm of the wrist, thereby facilitating compression of an ulnar artery.

22. The curved frame of claim 21 further comprising:

(i) a plurality of rungs; and

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

23. The curved frame of claim 22, further comprising 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.

24. The curved frame of claim 22, wherein the plurality of rungs are equidistant from each other along a length of the curved frame and have a spacing between the plurality of rungs of about 2 mm.

25. The curved frame of claim 22, wherein the plurality of rungs are staggered whereby some rungs are close to each other and some rungs are spread out.

26. The curved frame of claim 25, wherein a spacing between the plurality of rungs in a center portion of the curved frame is greater than a spacing between the plurality of rungs at proximal and distal ends of the curved frame.

27. The curved frame of claim 22, 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.

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

29. The curved frame of claim 22, wherein the at least two beams are circular and have a diameter of about 3 mm.

30. The curved frame of claim 21, wherein at least a portion of the curved frame is curved toward an inner peripheral side of the curved frame.