DESCRIPTION OF THE DRAWINGS
Referring to the drawings, FIG. 1 is a perspective view of the connected first and second pads of this invention, shown to be lying on the skin of a patient in open position.
FIG. 2 is a perspective view illustrating how a fistula, vein, or other blood vessel of a patient can be palpitated through the first pad of the device of this invention to locate the blood vessel.
FIG. 3 is a side view showing how a medical cannula can penetrate through the first pad of the device as shown in FIGS. 1-2, and may also penetrate through tissue of the patient, to reach a blood vessel underneath the skin.
FIG. 4 shows how the second pad may then be folded over after penetration of the cannula, to cover the cannula entry site and portions of the cannula.
FIG. 5 is a perspective view showing the configuration of FIG. 4, in reversed direction, after the cannula and device of this invention are taped together and onto the skin of the patient.
DESCRIPTION OF SPECIFIC EMBODIMENTS
Referring to the drawings, the hemostasis pad device 10 of this invention may comprise a first pad 12 and a second pad 14, connected together by a hinge 16 so that second pad 14 may be placed on top of first pad 12 by folding. This assembly of pads may be integrally molded together as a single, unitary item, if desired or, alternatively, separate first and second pads may be provided and used.
Each of pads 12, 14 are made, in this embodiment, of an elastomeric material having a Shore 00 durometer hardness on the order of 10, for example being a soft, transparent, oil plasticized elastomer such as the material made by Gel Concepts LLC, of Whippany, N.J., or other materials as described in the previously cited patent application publication.
First, soft pad 12 has a generally flat top and bottom, and a thickness on the order of 0.1 to 0.5 cm, so that it is possible to palpitate a blood vessel (FIG. 2) such as a fistula or a vein 18 under the skin 20 of the patient with a finger 22. It can be seen that FIG. 2 is significantly enlarged, when comparing the size of finger 22 to a normal finger. The diameter of each of first and second circular pads 12, 14 may be similar, in some embodiments, and may be on the order of 1-5 centimeters, for example. The pads may also be oval, rectangular, triangular, or the like.
As shown in FIGS. 1-3, both pads 12, 14 of the pad device 10 are shown to be lying on the patient's skin 20.
Second pad 14 is inverted from its normal position of use in FIG. 1, but is folded over as in FIG. 4, for use, so that its lower surface, 15, in use, is generally flat, and it has a raised-profile upper surface 17, which surfaces are inverted in FIGS. 1-3. Raised profile upper surface 17 of second pad 14 may be of a dome shape, but, as previously described, may be of another, desired, typically raised-profile shape, one such alternate shape being as shown in FIG. 5 of the previously cited U.S. patent application publication. Surface 17 may alternatively comprise a cubic structure or the like, to provide a raised profile where, typically, central portions of surface 17 are higher than peripheral portions of surface 17. The purpose of the raised profile is to facilitate the distribution of gentle, downward pressure of second pad 14 onto the surface of first pad 12 when folded on it as in FIG. 4, to achieve the advantages that can be achieved with the gentle pressure, applied to effectively stop bleedings while being gentle enough to not close off blood vessel 18, this being described in the previously cited patent application publication.
As shown in FIG. 2, blood vessel 18 is palpitated to determine its location within skin 20 by finger 22 in a conventional manner. Because of the thinness and softness of first pad 12, it is possible to palpitate blood vessels through the pad, as shown.
Then, when blood vessel 18 is so located by palpitation through first pad 12, a sharpened cannula such as a conventional winged needle set 25, having a conventional needle 24, is placed through pad 12 and skin 20 into blood vessel 18. Needle set 26 may also comprise a conventional hub 26, and wings 28, attached in conventional manner to flexible set tubing 31 for example, so that needle set 25 and tubing 31 may comprise a conventional fistula set. Needle 24 is conventionally inserted into blood vessel 18, which has been located by palpitation through pad 12, so that the needle hole 32 through skin 20 is located underneath first pad 12, and the needle extends through first pad 12.
Then, second pad 14 is folded about hinge 16 to overlie pad 12 and needle hole 32 in the skin, also overlying at least a portion of the needle 24 and hub 26, as shown in FIG. 4. Because of the high softness of second pad 14, its lower, flat surface 15 flexes to receive and accommodate for the presence of needle 24 and hub 26, to provide a structure that overlies needle hole 32, providing sealing for blood that seeps through needle hole 32 and the corresponding needle hole in first pad 12. Also, first pad 12, itself, by its soft nature and non-absorbent lower surface, as described in the cited patent application publication, provides sealing and prevention of the leakage of blood from skin hole 32.
Then, as shown in FIG. 5, winged needle assembly 25 may be secured to the skin 20 of the patient by strips of tape 30, conventionally applied in a desired, typically conventional pattern to retain needle assembly 25 and the folded pads 12, 14 of this invention in its desired position for the desired duration. This may be a period of hours, for example in the event of a conventional hemodialysis treatment, or even days in other circumstances, such as with an i.v. catheter. Bleeding is suppressed by the presence of the pad device of this invention.
Then, when needle assembly 25 is desired to be removed, it may be simply done by removing tape portions that cover said needle assembly, and withdrawing needle 24, without removal of the folded pads 14, 16. Because of the high softness and resilience of pads 12, 14, they simply close up the space that is vacated by needle hub 26 and needle 24, spontaneously providing an added seal against bleeding. Remaining tape portions that hold folded pads 14, 16 onto the skin may be reinforced with added tape at this point, if desired, for better retention.
The tape portions 30 that pass over the raised profile of upper surface 17 of pad 14 may convey downward pressure to central portions of pad 12 surrounding needle hole 32, to provide a gentle sealing pressure, typically of less pressure than was conventionally used to stop bleeding previously in the prior art, for improved maintenance of blood vessels, particularly fistulas and the like.
In some embodiments, the pads 14, 16 are both transparent and substantially pore free. Also, because of the presence of liquid oil plasticizer in preferred formulations that make the respective pads 14, 16, first pad 12 does not tend to adhere to a scab formed by bleeding under the pad as it rests on the patient, so that it can be more easily removed without damaging the scab.
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.
Patent Application
20080015482
