Apparatus and method to stop bleeding

• US 9,332,994 B2
• Filed: 08/05/2015
• Issued: 05/10/2016
• 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): Aleman, Sarah W
• Assistant Examiner(s): Boutsikaris, Socrates L
• Application Number:
  US14/819,383
• Publication Number:
  US 20150335334A1
• Time in Patent Office: 279 Days
• Field of Search: 606/201, 606/202, 606/203, 601/132, 601/151, 601/33, 601/40
• US Class Current: 1/1
• 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 2017/00889 antimicrobial, disinfectant
• CPC Class Codes: A61B 2017/00893 pharmaceutically effective
• CPC Class Codes: A61B 2017/00907 for light
• CPC Class Codes: A61B 2017/00951 adhesive
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 5/0261 using optical means, e.g. infrared light
• 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
• CPC Class Codes: A61B 90/92 coded with colour
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/10185 Valves

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 first balloon being larger than the second balloon. The bleeding from radial artery is stopped by compressing the radial artery at the puncture site using inflation of the first balloon and radial artery flow is increased by compression of ipsilateral ulnar artery using inflation of the second balloon.

Claims

1. A hemostatic device comprising:

a flexible band adapted to be wrapped around a wrist of a patient at a puncture site on the wrist where bleeding is to be stopped;

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

a curved frame having an inner peripheral side, the curved frame is made of a material such that the curved frame is more rigid than the band, and at least a portion of which is curved toward the inner peripheral side;

the curved frame possessing a first curved portion in a first half of the curved frame located between a center and a first end of the curved frame, a second curved portion in a second half of the curved frame located between the center and a second end of the curved frame, and an axis traversing from the first end of the curved frame, through the center, to the second end of the curved frame;

a first balloon provided on the inner peripheral side in the first half of the curved frame at a position deviated to the center of the curved frame from the first end of the curved frame in a lengthwise direction of the band, the first balloon having a plurality of linear sides and is connected to the band by a first connector only on a first linear side of the first balloon, said first linear side of the first balloon being adjacent the center of the curved frame and perpendicular to the axis of the curved frame, the first balloon having a first surface and at least a second linear side in contact with the band, wherein the first balloon inflates when a fluid is introduced therein and upon inflation the first surface and at least the second linear side of the first balloon are capable of moving out of contact with the band; and

a second balloon provided on the inner peripheral side in the second half of the curved frame at a position deviated to an edge of the curved frame from the center of the curved frame in a widthwise direction of the band, the second balloon having a plurality of linear sides and is connected to the band by a second connector only on a first linear side of the second balloon, the second balloon having a second surface and at least a second linear side in contact with the band, wherein the second balloon inflates when the fluid is introduced therein and upon inflation the second surface and at least the second linear side of the second balloon are capable of moving out of contact with the band.

2. The hemostatic device of claim 1, wherein the width of the first balloon is about the same as the width of the band and the width of the second balloon is less than 70% of the width of the band.

3. The hemostatic device of claim 1, wherein the band, the curved frame, and the first balloon are made of substantially transparent material, which allows the site where bleeding is to be stopped to be viewed through the band, through the curved frame, and through the first balloon.

4. The hemostatic device of claim 3, wherein a radius of curvature of the first curved portion of the curved frame is nearly the same as a radius of curvature of the second curved portion of the curved frame.

5. The hemostatic device of claim 4, further comprising a first sleeve including a double layer construction defining a curved frame holder, and the curved frame is positioned in a gap in the double layer construction such that the curved frame is held in the curved frame holder of the band.

6. The hemostatic device of claim 5, further comprising a marker for positioning the first balloon at the site where bleeding is to be stopped.

7. The hemostatic device of claim 5, further comprising a first tube communicating with an interior of the first balloon, a first adapter connected to the first tube and into which a first syringe is insertable to introduce the fluid in the first syringe into the first balloon by way of the first tube, and a second tube communicating with an interior of the second balloon, a second adapter connected to the second tube and into which a second syringe is insertable to introduce the fluid in the second syringe into the second balloon by way of the second tube.

8. The hemostatic device of claim 5, wherein the curved frame is made of a material that is bendable such that the curved frame does not maintain a substantially fixed shape.

9. The hemostatic device of claim 7, further comprising a second sleeve including a double layer construction defining an adapter holder for the first adapter and the second adapter, and the first adapter and the second adapter are positioned in a gap in the double layer construction such that the first and the second adapter are held in the adapter holder of the band.

10. The hemostatic device of claim 7, wherein the first adapter is identifiably different from the second adapter, wherein the identifiable difference comprises color, shape, texture or combination thereof.

11. The hemostatic device of claim 7, wherein a surface of the first balloon that will contact skin at the puncture site is disposed with vasodilator medication.

12. The hemostatic device of claim 7, wherein surfaces of the first and the second balloon that will contact skin are coated with medical grade adhesive.

13. The hemostatic device of claim 7, wherein the fastener comprises a hook material and a loop material, wherein the hook material is placed at a first end of the band and the loop material is placed at a second end of the band.

14. The hemostatic device of claim 1, wherein the width of the band is greater than 40 mm.

15. The hemostatic device of claim 2, wherein the width of the band is about 55 mm.

16. A hemostatic device comprising:

a flexible band adapted to be wrapped around a wrist of a patient at a puncture site on the wrist where bleeding is to be stopped;

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

a curved plate having an inner peripheral side, the curved plate is made of a material such that the curved plate is more rigid than the band, and at least a portion of which is curved toward the inner peripheral side;

the curved plate possessing a first curved portion in a first half of the curved plate located between a center and a first end of the curved plate, a second curved portion in a second half of the curved plate located between the center and a second end of the curved plate, and an axis traversing from the first end of the curved plate, through the center, to the second end of the curved plate;

a first balloon provided on the inner peripheral side in the first half of the curved plate at a position deviated to the center of the curved plate from the first end of the curved plate in a lengthwise direction of the band, the first balloon having a plurality of linear aides and is connected to the band by a first connector only on a first linear side of the first balloon, said first linear side of the first balloon being adjacent the center of the curved plate and perpendicular to the axis of the curved plate, the first balloon having a first surface and at least a second linear side in contact with the band, wherein the first balloon inflates when a fluid is introduced therein and upon inflation the first surface and at least the second linear side of the first balloon are capable of moving out of contact with the band; and

a second balloon provided on the inner peripheral side in the second half of the curved plate at a position deviated to an edge of the curved plate from the center of the curved plate in a widthwise direction of the band, the second balloon having a plurality of linear sides and is connected to the band by a second connector only on a first linear side of the second balloon, the second balloon having a second surface and at least a second linear side in contact with the band, wherein the second balloon inflates when the fluid is introduced therein and upon inflation the second surface and at least the second linear side of the second balloon are capable of moving out of contact with the band.

17. The hemostatic device of claim 16, wherein the band, the curved plate, and the first balloon are made of substantially transparent material, which allows the site where bleeding is to be stopped to be viewed through the band, through the curved plate, and through the first balloon.

18. The hemostatic device of claim 17, wherein a radius of curvature of the first curved portion of the curved plate is nearly the same as a radius of curvature of the second curved portion of the curved plate, and the curved plate is made of material such that the plate maintains a substantially fixed shape.

19. A hemostatic device, comprising:

a substantially transparent, flexible band adapted to be wrapped around a wrist of a patient at a puncture site on the wrist where bleeding is to be stopped;

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

a substantially transparent curved frame having an inner peripheral side, the curved frame is made of a material such that the curved frame is more rigid than the band, and at least a portion of which is curved toward the inner peripheral side;

the curved frame possessing a first curved portion in a first half of the curved frame located between a center and a first end of the curved frame, a second curved portion in a second half of the curved frame located between the center and a second end of the curved frame, and an axis traversing from the first end of the curved frame, through the center, to the second end of the curved frame;

a substantially transparent first balloon provided on the inner peripheral side in the first half of the curved frame at a position deviated to the center of the curved frame from the first end of the curved frame in a lengthwise direction of the band, the first balloon having a plurality of linear sides and is-connected to the band by a first connector only on a first linear side of the first balloon, said first linear side of the first balloon being adjacent the center of the curved frame and perpendicular to the axis of the curved frame, the first balloon having a first surface and at least a second linear side in contact with the band, wherein the first balloon inflates when a fluid is introduced therein and upon inflation the first surface and at least the second linear side of the first balloon are capable of moving out of contact with the band; and

a substantially transparent second balloon provided on the inner peripheral side in the second half of the curved frame at a position deviated to an edge of the curved frame from the center of the curved frame in a widthwise direction of the band, the second balloon having a plurality of linear sides and is connected to the band by a second connector only on a first linear side of the second balloon, the second balloon having a second surface and at least a second linear side in contact with the band, wherein the second balloon inflates when the fluid is introduced therein and upon the second surface and at least the second linear side of the second balloon are capable of moving out of contact with the band.

20. The hemostatic device of claim 19, wherein a radius of curvature of the first curved portion of the curved frame is nearly the same as a radius of curvature of the second curved portion of the curved frame, and the curved frame is made of a material that is bendable such that the curved frame does not maintain a substantially fixed shape.

21. A hemostatic device comprising:

a flexible band adapted to be wrapped around a wrist of a patient at a puncture site on the wrist where bleeding is to be stopped;

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

a curved frame having an inner peripheral side, the curved frame is made of a material such that the curved frame is more rigid than the band, and at least a portion of which is curved toward the inner peripheral side;

the curved frame possessing a first curved portion in a first half of the curved frame located between a center and a first end of the curved frame, a second curved portion in a second half of the curved frame located between the center and a second end of the curved frame, and an axis traversing from the first end of the curved frame, through the center, to the second end of the curved frame;

a first balloon provided on the inner peripheral side in the first half of the curved frame at a position deviated to the center of the curved frame from the first end of the curved frame in a lengthwise direction of the band, the first balloon having a plurality of linear sides and is connected to the band by a first connector only on a first linear side of the first balloon, said first linear side of the first balloon being adjacent the center of the curved frame and perpendicular to the axis of the curved frame, the first balloon having a first surface and at least a second linear side in contact with the band, wherein the first balloon inflates when a fluid is introduced therein and upon inflation the first surface and at least the second linear side of the first balloon are capable of moving out of contact with the band;

a second balloon provided on the inner peripheral side in the second half of the curved frame at a position deviated to an edge of the curved frame from the center of the curved frame in a widthwise direction of the band, the second balloon having a plurality of linear sides and is connected to the band by a second connector only on a first linear side of the second balloon, the second balloon having a second surface and at least a second linear side in contact with the band, wherein the second balloon inflates when the fluid is introduced therein and upon inflation the second surface and at least the second linear side of the second balloon are capable of moving out of contact with the band;

a first tube communicating with an interior of the first balloon, a first adapter connected to the first tube and into which a first syringe is insertable to introduce the fluid in the first syringe into the first balloon by way of the first tube, and a second tube communicating with an interior of the second balloon, a second adapter connected to the second tube and into which a second syringe is insertable to introduce the fluid in the second syringe into the second balloon by way of the second tube;

a first sleeve including a double layer construction defining a curved frame holder, and the curved frame is positioned in a gap in the double layer construction such that the curved frame is held in the curved frame holder of the band;

a second sleeve including a double layer construction defining an adapter holder for the first adapter and the second adapter; and

the first adapter and the second adapter are positioned in a gap in the double layer construction such that the first and the second adapter are held in the adapter holder;

wherein the band, the curved frame, and the first balloon are made of substantially transparent material which allows the site where bleeding is to be stopped to be viewed through the band, through the curved frame; and

through the first balloon; and

wherein a radius of curvature of the first curved portion is nearly the same as a radius of curvature of the second curved portion.