Resilient hemostasis devices

Abstract

A soft hemostasis pad of elastomeric material typically having a hardness of no more than about 50 Shore 00 and an upper wall having a raised profile, such as a convex shape. The pad has a central aperture extending therethrough, and a slit that extends through the pad thickness between the central aperture and the periphery of the pad.

Description

DESCRIPTION OF THE DRAWINGS

In the drawings, FIG. 1 is a perspective view of the pad of this invention.

FIG. 2 is a plan view of the pad of FIG. 1.

FIG. 3 is an elevational view of the pad of FIGS. 1 and 2.

FIG. 4 is a perspective view, showing how the pad of FIGS. 1-3 may be applied to the skin and placed to surround a catheter that is implanted therein, extending through the skin.

FIG. 5 is a perspective view showing how the pad of this invention can be reclosed in surrounding relationship of the implanted catheter of FIG. 4.

FIG. 6 is a plan view of another design of the pad of this invention.

FIG. 7 is a side elevational view of the pad of FIG. 6, viewed along its longest dimension.

FIG. 8 is an end elevational view of the pad of FIG. 6.

DESCRIPTION OF SPECIFIC EMBODIMENTS

Referring to FIGS. 1-5, a soft, hemostasis pad of elastomeric material 10 is shown. Pad 10 has a periphery 12, and is made, typically by molding, of an elastomeric material having a hardness on the order of 30 Shore 00. Specifically, Gel Concepts oil-plasticized thermoplastic elastomer is a desirable candidate, as described above.

Pad 10 defines an raised profile upper wall 14 of convex, domed shape, and also defines a substantially flat, non-porous bottom 16. Pad 10 is solid and transparent, having a central aperture 18, open at both the top and the bottom 20. Additionally, slit 22 extends through the pad thickness between central aperture 18 and periphery 12 so that the entire length of central aperture 18 is opened at slit inner end 24 for access by a catheter 26.

This is illustrated in FIG. 4, in which percutaneous catheter 26, implanted in a patient, and extending through the patient's skin 28 (so that a portion 26a of catheter 26 is under the skin 28 as is well known). The aperture in the skin where a catheter 26 joins the skin and extends therethrough is an area where blood can seep out onto the skin, and it becomes a site for infection, particularly with a long-term indwelling catheter. By this invention, pad 10 can be placed to surround an indwelling catheter 26 by opening of slit 22 as shown, which opens inner slit line 24 running the length of central aperture 18, to permit central aperture 18 to laterally receive catheter 26 and to surround it, as shown in FIG. 5. Slit 22 can be reclosed, being held together by the natural tack of the soft, resilient material of which pad 10 is made, as pad 10 rests with its bottom surface 16 resting on the skin 28. Thus, slit 22 is opened to laterally insert catheter 26 into central aperture 18. Then slit 22 is reclosed, and remains in reclosed position by natural tack adhesion. Also, pad 10 may be taped onto the skin to provide additional retention of the pad on the skin, and to assist in the maintenance of the reclosed condition of slit 22.

In this embodiment, the outer diameter of catheter 26 may be about 3 mm to 12 mm and greater than the unstressed diameter of the central aperture 18, which may be about 0.5 times to 0.95 times the catheter diameter. Thus, a compression seal is provided around catheter 26 within central aperture 18. The seepage of fluids from the catheter entrance site through the skin is sealed off and suppressed.

A medicament may be present on the flat, solid bottom surface 16, such as an antimicrobial agent, or another healing aid. If desired, this may be accomplished by placing the antimicrobial agent in the formulation of the entire pad material, so that it is present on all surfaces and in the interior of pad 10. For example, an effective amount (such as 0.001 to 0.1 weight percent) of colloidal silver may be added to the pad formulation, providing antimicrobial conditions on all surfaces of pad 10 including bottom surface 16, and the inner lumen surface of central aperture 18. The outer, circular periphery of bottom surface 16 may have a diameter of about 4 to 10 times the outer diameter of the catheter at the annular seal point, and the maximum thickness of pad 10 may be about 1 to 5 times the outer diameter of the catheter at the annular seal point, in this embodiment.

In the embodiment of FIGS. 1-5, central aperture 18 extends through pad 10 at a perpendicular angle to flat bottom 16. If desired, this angle may be varied, as described above, to accommodate different angles of indwelling catheters as they enter the skin.

As stated before, because of the presence of an oil plasticizer in the preferred formulation used to make pad 10, the oil plasticizer suppresses adherence of pad 10 to any scab that is formed by bleeding under bottom surface 16, as pad 10 rests on skin 28.

Referring to FIGS. 6-8, another embodiment of the pad of this invention is provided.

Pad 10a may be made from a similar oil-plasticized, soft, transparent, elastomer material as in the previous embodiment, comprising a flat, bottom wall 16a and a solid, transparent body, also comprising a convex, upper wall 14a. However, in this circumstance, contrary to the previous embodiment in which the convex upper wall is a dome shape, curving in two dimensions, the curvature of convex, upper wall 14a is a curvature in one dimension, so that upper wall 14a is of the shape of an inverted trough, having substantially similar cross sections along its length, contrary to the previous embodiment. As one advantage of this structure, the basic body of pad 10a can be extruded through a die aperture which is typically of D shape, for simplicity of manufacture.

Pad 10a also defines central aperture 18a, as in the previous embodiment, extending through the thickness of pad 10a and open at both ends. If desired, as indicated in FIGS. 6 and 7, central aperture 18a is not perpendicular to flat bottom 16a, but defines a desired angle thereto, to accommodate and receive catheters that are implanted through the skin of a patient at a similar angle. Alternatively, central aperture 18a may be perpendicular to surface 16a, if that is desired.

Slit 22a then is placed through the thickness of pad 10a in a direction parallel to the direction of central aperture 18a, so at the inner surface 24a of slit 22a extends along the length of central aperture 18a to open it, so that a catheter may be placed laterally through slit 22a to occupy central aperture 18a, and be sealed and supported by pad 10a resting on the skin and surrounding the catheter.

If desired, pad 10a (or pad 10) may be placed around the catheter (or needle) before the catheter is inserted into the body and the pad bottom is then mated to the skin, as may be preferable in certain surgical procedures. Also pad 10a (or pad 10) may be placed around the catheter and onto the skin after the catheter is inserted into the patient as may be preferable in long dwelling catheters such as dialysis catheter.

As before, it is preferred for the catheter used to have an outer diameter slightly larger than the diameter of central aperture 18a, so that a compression seal is provided around the catheter, but slit 22a is capable of being reclosed and sealed together by tack adhesion, although this seal can be reinforced by taping of pad 10a on the skin, as in the previous embodiment.

It is also possible to provide a medicament such as colloidal silver to the formulation of pad 10a, if desired.

Thus, a pad for catheters and the like provides support and sealing at the skin entry site. The pads provide hemostasis and sealing against body fluid seepage, while the catheter remains in implanted condition. Also, the pad may be modified to have an antimicrobial characteristic, or any other medicament may be applied to the pad to serve its desired purpose.

The above has been offered for illustrative purposes only, and is not intended to limit the scope of the invention of this application, which is as defined in the claims below.

Claims

1. A soft hemostasis pad of elastomeric material having a periphery and a hardness of no more than about 50 Shore 00, said pad having an upper wall of raised profile with a generally flat, non-porous bottom, said pad having a central aperture extending therethrough and a slit that extends through the pad thickness between said central aperture and said periphery.

2. The pad of claim 1 in which the pad is made of a tacky material, whereby said slit may be opened to laterally insert a canteter into said central aperture and then to reclose the slit by tack adhesion.

3. The pad of claim 2 that has a catheter occupying said central aperture, the inner diameter of the pad being 0.5 to 0.95 times, the unstressed diameter of the catheter to effect a seal around the catheter in the central aperture, while at least most of the slit is reclosed by said tack adhesion.

4. The pad of claim 1 which at least the bottom of which is made of a solid, transparent, pore-free material.

5. The pad of claim 2 in which the hardness is no more than about 35 Shore 00.

6. The pad of claim 1 in which a medicament is present on the flat, solid bottom.

7. The pad of claim 6 in which said medicament comprises silver nanoparticles distributed throughout the pad, said pad being transparent.

8. The paid of claim 1 in which the upper wall has a generally convex, raised profile.

9. The pad of claim 1 in which the upper wall has a generally convex, raised profile, said pad being transparent, and at least the bottom of said pad being pore-free.

10. The pad of claim 1 in which the central aperture has an axis that defines an angle to the substantially flat bottom of 20° to 900.

11. The pad of claim 1 in which the upper wall raised profile is a dome shape.

12. The pad of claim 1 in which said elastomeric material contains a liquid plasticizer, whereby the material does not significantly adhere to a scab formed by bleeding under the solid bottom as the pad rests on the skin of a patient.

13. The method which comprises: placing a soft, resilient, pore-free hemostasis pad having a periphery, a central aperture, and a slit extending between the periphery and the aperture on the skin of a patient with a catheter extending through the patient's skin and occupying the central aperture, and substantially closing the slit by tack adhesion, to suppress bleeding around the catheter.

14. The method of claim 13 in which said pad comprises an elastomer having a hardness of no more than about 50 Shore 00, said pad having an upper wall of raised profile with a flat bottom.

15. The method of claim 14 in which the hardness is no more than about 35 Shore 00.

16. The method of claim 14 in which said upper wall is of convex shape, and said central aperture is positioned at substantially the thickest part of said pad.

17. The method of claim 13 in which said central aperture has an inner diameter which, in unstressed condition, is from 50 to 95 percent of the catheter outer diameter.

18. The method of claim 13 in which said pad is substantially transparent.

19. The method of claim 14 in which an antiseptic is present on the flat bottom.

20. A soft, solid, transparent, pore-free pad of elastomeric material having a periphery and a hardness of no more than about 50 Shore 00, said pad having an upper wall of convex shape with a substantially flat, solid bottom, said pad having a central aperture extending therethrough, and a slit that extends through the pad thickness between said central aperture and the periphery to permit the lateral installation of a catheter or the like in said central aperture, said pad comprising an elastomeric material that contains a liquid plasticizer, whereby the material does not significantly adhere to a scab formed by bleeding under the solid bottom as the pad rests on the skin of a patient.

21. The pad of claim 20 in which the hardness is no more than about 35 Shore 00.

22. The pad of claim 21 in which said pad contains an antimicrobial concentration of silver nanoparticles distributed at least within the bottom of the pad, said pad being substantially transparent.

23. The pad of claim 20 in which the upper wall convex shape is a dome shape.

24. The pad of claim 20 in which a catheter occupies said central aperture, the outer diameter of the catheter being slightly greater than the unstressed diameter of the central aperture, to effect a seal around the catheter in the central aperture while permitting at least most of the slit to be reclosed by said tack adhesion.