Apparatus and method to stop bleeding

• US 10,117,672 B2
• Filed: 02/18/2018
• Issued: 11/06/2018
• 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:
  US15/898,591
• Publication Number:
  US 20180168662A1
• Time in Patent Office: 261 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 hemostatic device configured to be applied to a wrist of a patient, the hemostatic device comprising:

a flexible band to be applied to the wrist of the patient in a wrapped state in which the flexible band is wrapped around at least a portion of the wrist of the patient to apply the hemostatic device to the wrist of the patient at a site where bleeding is to be stopped;

a compression member made of a material more rigid than the flexible band, the compression member and the flexible band being connected to each other so that when the flexible band is in the wrapped state the compression member is positioned on the wrist of the patient at the site on the wrist where bleeding is to be stopped, the compression member possessing an inner peripheral side which faces toward the wrist of the patient when the flexible band is in the wrapped state, a portion of the inner peripheral side of the compression member being a first curved portion that is curved toward the inner peripheral side;

a fastener for securing the flexible band in the wrapped state to the patient'"'"'s wrist;

an inflatable first balloon that is inflatable upon introducing a fluid into the first balloon, the first balloon being located on the inner peripheral side of the compression member at a location deviated to a center of the compression member from a first end of the compression member in a lengthwise direction of the flexible band;

the first balloon being connected to the flexible band only by a first connector on a first linear side of the first balloon, the first linear side of the first balloon being adjacent the center of the compression member and perpendicular to an axis of the compression member, the first connector being directly attached to the flexible band at about the center of the compression member, said axis traversing from the first end of the compression member, through the center, to a second end of the compression member; and

the portion of the inner peripheral side of the compression member that is curved being between the first end of the compression member and the center of the compression member.

2. The hemostatic device of claim 1, wherein upon inflation the first balloon assumes an orientation whereby a compressive force is applied directly to the site, the compressive force in totality being in an oblique direction pointing outwards away from the center of the wrist and not towards the center of the wrist, and wherein the site is on a radial artery.

3. The hemostatic device of claim 1, wherein a first portion of the first balloon is located under a center portion of the compression member that is flat, and a second portion of the first balloon is located under the first curved portion of the compression member.

4. The hemostatic device of claim 1, wherein the compression member is selected from a group consisting of:

(i) a curved plate and (ii) a curved frame comprising of rungs.

5. The hemostatic device of claim 4, wherein the flexible band, the compression member, and the first balloon are made of substantially transparent material, such that the site where bleeding is to be stopped may be viewed through the flexible band, through the compression member, and through the first balloon.

6. The hemostatic device of claim 5, wherein the compression member possesses the first curved portion in a first half of the compression member located between the center and the first end of the compression member, and a second curved portion in a second half of the compression member located between the center and the second end of the compression member.

7. The hemostatic device of claim 6, further comprising an inflatable second balloon that is inflatable upon introducing the fluid in the second balloon, the second balloon located in the inner peripheral side of the compression member in the second half of the compression member.

8. The hemostatic device of claim 7, wherein the second balloon is connected to the flexible band by a second connector on a first linear side of the second balloon.

9. The hemostatic device of claim 8, wherein the second balloon is at a location offset to an edge of the compression member from the center of the compression member and wherein the first linear side of the second balloon is adjacent the edge of the compression member and parallel to the axis of the compression member.

10. The hemostatic device of claim 1, further comprising at least a sleeve including a double layer construction defining a compression member holder, and the compression member is positioned in a gap in the double layer construction such that the compression member is held in the compression member holder of the flexible band.

11. The hemostatic device of claim 1, wherein the fastener comprises a hook material and a loop material, wherein the hook material is placed at a first end of the flexible band and the loop material is placed at a second end of the flexible band.

12. A hemostatic device comprising:

a flexible band configured to be wrapped around at least a portion of a wrist of a patient to apply the hemostatic device to the wrist of the patient at a site on a surface of the patients wrist at which bleeding is to be stopped, said site being at a radial artery;

a fastener for securing the flexible band in a wrapped state to the patient'"'"'s wrist;

a curved portion possessing an inner side that faces towards the wrist of the patient when the hemostatic device 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 hemostatic device 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 made of a material more rigid than the flexible band;

the curved portion and the flat portion being provided on the flexible band so that when the hemostatic device 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

an inflatable first balloon that inflates when a fluid is introduced into the first balloon, the first balloon being located at the flat inner side of the flat portion, the first balloon applying a compressive force to the site on the surface of patients wrist, the compressive force in totality being in an oblique direction with respect to the surface of the wrist and originating from the flat inner side of the flat portion, wherein the flat inner side of the flat portion is in congruence with a substantially flat outer side of the wrist,

wherein the curved portion and the flat portion are parts of a compression member, the first balloon being located on an inner peripheral side of the compression member at a location deviated to a center of the compression member from a first end of the compression member in a lengthwise direction of the flat portion, the first balloon being connected to the flexible band only by a first connector on a first linear side of the first balloon, the first linear side of the first balloon being adjacent the center of the compression member and perpendicular to an axis of the compression member, the first connector being directly attached to the flexible band at about the center of the compression member, said axis traversing from the first end of the compression member, through the center, to a second end of the compression member.

13. The hemostatic device of claim 12, wherein the first balloon located at the flat inner side of the flat portion, the first balloon having a protrusion into the curved inner side of the curved portion, the first balloon not applying a compressive force originating from the curved inner side of the curved portion to the site on the surface of the patient'"'"'s wrist in an oblique direction with respect to the surface of the wrist.

14. The hemostatic device of claim 12, wherein the compression member is selected from a group consisting of:

(i) a curved plate and (ii) a curved frame comprising plurality of rungs.

15. The hemostatic device of claim 12, wherein the flexible band, the compression member, and the first balloon are made of substantially transparent material, such that the site where bleeding is to be stopped may be viewed through the flexible band, through the compression member, and through the first balloon.

16. The hemostatic device of claim 12, further comprising a sleeve including a double layer construction defining a compression member holder, and the compression member is positioned in a gap in the double layer construction such that the compression member is held in the compression member holder of the flexible band.

17. The hemostatic device of claim 12, wherein the fastener comprises a hook material and a loop material, wherein the hook material is placed at a first end of the flexible band and the loop material is placed at a second end of the flexible band.

18. The hemostatic device of claim 12, wherein the curved portion comprises a first curved portion and a second curved portion, wherein the compression member possesses the first curved portion in a first half of the compression member located between the center and the first end of the compression member, and the second curved portion in a second half of the compression member located between the center and the second end of the compression member.

19. The hemostatic device of claim 18, further comprising an inflatable second balloon that is inflatable upon introducing the fluid in the second balloon, the second balloon located in the inner peripheral side of the compression member in the second half of the compression member.

20. The hemostatic device of claim 19, wherein the second balloon is connected to the flexible band by a second connector on a first linear side of the second balloon.

21. The hemostatic device of claim 20, wherein the second balloon is at a location offset to an edge of the compression member from the center of the compression member and wherein the first linear side of the second balloon is adjacent the edge of the compression member and parallel to the axis of the compression member.

22. A hemostatic device configured to be applied to a wrist of a patient, the hemostatic device comprising:

a flexible band to be applied to the wrist of the patient in a wrapped state in which the flexible band is wrapped around at least a portion of the wrist of the patient to apply the hemostatic device to the wrist of the patient at a site on a radial artery where bleeding is to be stopped;

a fastener for securing the flexible band in the wrapped state to the patients wrist;

a compression member more rigid than the flexible band, the compression member and the flexible band being connected to each other so that when the flexible band is in the wrapped state the compression member is positioned on the wrist of the patient at the site on the wrist where bleeding is to be stopped, the compression member possessing an inner peripheral side which faces toward a surface of the wrist of the patient when the flexible band is in the wrapped state;

one portion of the inner peripheral side of the compression member being a curved portion that is curved toward the inner peripheral side, another portion of the inner peripheral side of the compression member being a flat portion;

an inflatable first balloon that is inflatable upon introducing fluid into the first balloon, the first balloon being on the inner peripheral side of the compression member at a location deviated to a center of the compression member from a first end of the compression member in a lengthwise direction of the flexible band; and

a first portion of the first balloon being positioned at the flat portion of the inner peripheral side of the compression member so that when the flexible band is in the wrapped state and the first balloon is inflated, the first balloon applies a compressive force to the site on the radial artery, said compressive force in totality being in an oblique direction with respect to the surface of the wrist and pointing in an outward direction away from a center portion of the wrist, with no component of the compressive force directed towards an ipsilateral ulnar artery,

wherein the first balloon is connected to the flexible band only by a first connector on a first linear side of the first balloon, the first linear side of the first balloon being adjacent the center of the compression member and perpendicular to an axis of the compression member, the first connector being directly attached to the flexible band at about the center of the compression member, said axis traversing from the first end of the compression member, through the center, to a second end of the compression member.

23. The hemostatic device of claim 22, further comprising a second portion of the first balloon, the second portion of the first balloon being smaller than the first portion of the first balloon, the second portion of the first balloon being positioned at the curved portion of the inner peripheral side of the compression member so that when the flexible band is in the wrapped state and the first balloon is inflated, the compressive force applied to the site in the oblique direction is not pointing inwards towards the center portion of the wrist.

24. The hemostatic device of claim 22, wherein the curved portion comprises a first curved portion and a second curved portion, wherein the compression member comprises the first curved portion in a first half of the compression member located between the center and the first end of the compression member, and the second curved portion in a second half of the compression member located between the center and the second end of the compression member, and the hemostatic device further comprises an inflatable second balloon that is inflatable upon introducing the fluid in the second balloon, the second balloon being positioned in the inner peripheral side of the compression member in the second half of the compression member, wherein the second balloon is connected to the flexible band by a second connector on a first linear side of the second balloon.

25. The hemostatic device of claim 24, wherein the second balloon is at a location offset to an edge of the compression member from the center of the compression member and wherein the first linear side of the second balloon is adjacent the edge of the compression member and parallel to the axis of the compression member.

26. The hemostatic device of claim 23, wherein the curved portion of the compression member is made of a solid plastic curved piece.