Resilient double pad hemostasis devices

• US 20080015482A1
• Filed: 07/13/2006
• Published: 01/17/2008
• Est. Priority Date: 07/13/2006
• Status: Abandoned Application

• Current Assignee: Medisystems Corporation (Fresenius Medical Care AG)
• Original Assignee: Medisystems Corporation (Fresenius Medical Care AG)
• Inventors: Schnell, William J., Utterberg, David S., Bell, David
• Application Number:
  US11/485,910
• Publication Number:
  US 20080015482A1
• Time in Patent Office: Days
• US Class Current: 602/48
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae

Abstract

A soft hemostasis pad of elastomeric material having a hardness of no more than about 50 Shore 00 and an upper surface of raised profile, such as a dome. The pad may be connected by a hinge with another, generally flat-bottom pad of similar elastomeric material and hardness of no more than about 50 Shore 00. The pad may rest on the skin and be penetrated by a needle or other cannula. The pad with the raised profile may then be placed over on top of the needle, for improved hemostasis and sealing when the cannula is removed and before, facilitated by the application of gentle pressure, such as by tape that holds the pads in place.

Claims

1. The method which comprises:

applying a first, soft pad to the skin of a patient, said pad consisting essentially of an elastomer having a hardness of no more than about durometer 50 Shore 00;

passing a medical cannula through the pad into the tissue of the patient;

overlying the first, soft pad and medical needle with a second, soft pad of elastomeric material having a hardness of no more than about 50 Shore 00, said second pad having a raised-profile upper surface and a generally flat bottom; and

securing the second, soft pad in place on said first, soft pad and said medical needle cannula with pressure against the skin.

2. The method of claim 1 comprising the step of withdrawing the cannula from the patient without removing the first and second, soft pads from their positions, whereby bleeding is suppressed.

3. The method of claim 1 in which the first and second, soft pads are peripherally connected by a hinge.

4. The method of claim 1 in which said first and second, soft pads are integrally formed from a transparent, substantially pore-free material.

5. The method of claim 1 in which the hardness of each of said first and second soft pads is no more than about durometer 35 Shore 00.

6. The method of claim 1 in which the first pad is thin enough to allow palpitation of a blood vessel of the patient through the pad, and including the steps of palpitating the blood vessel prior to passing the medical cannula through the first pad and into the blood vessel.

22. The method of claim 1 in which the first pad is thin enough to allow palpitation of a blood vessel of the patient through the pad, and including the step of palpitating the blood vessel through the pad prior to passing the medical cannula through the first pad and into the blood vessel.

7. A first, soft, hemostasis pad of elastomeric material having a hardness of no more than about 50 Shore 00, said first pad having a generally flat and non-absorbent lower surface and a second, soft pad peripherally connected by a hinge to said first, soft pad, said second, soft pad comprising an elastomeric material having a hardness of no more than about durometer 50 Shore 00, said second soft pad having a raised profile upper surface and a generally flat, lower surface, said second, soft pad being capable of folding by said hinge to abut the flat, solid bottom of the second, soft pad against a major face of said first, soft pad.

8. The first and second soft pads of claim 7 in which each pad has a hardness of no more than about durometer 35 Shore 00.

9. The first and second soft pads of claim 7 in which said first and second pads are integrally molded.

10. The first and second soft pads of claim 9 in which the second, soft pad has a dome-shaped upper surface.

11. The first and second soft pads of claim 7 in which the elastomeric material of at least said first soft pad contains a liquid plasticizer, whereby said first, soft pad does not significantly adhere to a scab formed by bleeding under the first soft pad as the first, soft pad rests on the skin of a patient.

12. The first and second soft pads of claim 7 in which said raised profile upper surface is a dome.

13. The first and second soft pads of claim 12 in which said first and second pads are integrally molded from a transparent, substantially pore-free material.

14. The first and second soft pads of claim 13 in which the elastomeric material of at least said first soft pad contains a liquid plasticizer, whereby said first soft pad does not significantly adhere to a scab formed by bleeding under the first soft pad as the first soft pad rests on the skin of a patient.

15. The first and second soft pads of claim 14 in which of each of said soft pads has a hardness of no more than about 35 Shore 00.

16. The first and second pads of claim 7 which are of porous construction, except for at least said first pad'"'"'s lower surface, which is non-absorbent.

17. The method which comprises:

applying a first, soft pad to the skin of a patient, said pad consisting of essentially of elastomer having a hardness of no more than about durometer 50 Shore 00;

passing a medical needle through the first pad into the tissue of the patient;

overlying the first, soft pad with medical cannula with a second, soft pad of elastomeric material having a hardness of no more than about 50 Shore 00, said overlying taking place by folding said second, soft pad about a hinge connected to the first, soft pad, to place said second, soft pad on top of said first, soft pad and needle, said second soft pad having a raised profile upper surface and a generally flat bottom;

securing the second, soft pad in place on said first, soft pad and said medical needle with pressure against the skin;

and thereafter withdrawing the cannula from the patient without removing the first and second, soft pads from their positions, whereby bleeding is suppressed.

18. The method of claim 17 in which said first and second soft pads are integrally formed from a transparent, substantially pore free material.

19. The method of claim 18 in which the hardness of each of said first and second soft pads is no more than about 35 Shore 00.

20. The method of claim 17 in which at least said first, soft pad contains a liquid plasticizer, whereby the first, soft pad does not significantly adhere to a scab formed by bleeding under the first, soft pad as the first, soft pad rests on the skin of the patient.

21. The method of claim 17 in which the first pad is thin enough to allow palpitation of a blood vessel of the patient through the pad, and including the step of palpitating the blood vessel through the pad prior to passing the medical cannula through the first pad and into the blood vessel.