Aseptic protector for skin penetrating devices

Surgery – Means for introducing or removing material from body for... – Treating material applied to or removed from external...

Reexamination Certificate

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Details

C602S011000, C602S022000, C602S030000

Reexamination Certificate

active

06183452

ABSTRACT:

BACKGROUND OF THE INVENTION
The present invention relates to an aseptic protector and, in particular, to an aseptic protector for use with skin penetrating devices that functions: to prevent, inhibit or arrest infection where the skin penetrating device penetrates a patient's skin; as a buffer to prevent injury to a patient or clinician or damage to the skin penetrating device; and to inhibit unwanted movement of the skin penetrating device once it is in place.
Frequently, medical procedures commonly used in plastic, general, orthopedic and oral surgery involve the use of skin penetrating devices, such as but not limited to, pins to maintain bones or sections of fractured bones in a fixed relationship and proper alignment with respect to each other; intravenous lines; plastic drain tubes for draining fluids from within the body after a medical procedure has been performed; and other similar devices. In many instances these skin penetrating devices may have to remain in place for long periods of time, e.g. about three to six weeks in certain orthopedic procedures, and circumstances may prevent washing the skin in the general area of the skin penetrating device. The points of skin penetration by these devices are potential locations where infectious processes can commence and spread into the body. Thus, there has long been a need to provide a sterile, aseptic environment about these skin penetrating devices where the devices pass though the skin of the patient.
Another problem encountered in the use of these skin penetrating devices is the need to keep these devices from being inadvertently damaged and/or moved by external forces, e.g. when a patient or a clinician inadvertently brushes the protruding portion of the skin penetrating device against or rapidly brings the protruding portion of the skin penetrating device into contact with something hard or catches the device on a piece of clothing or other more rigid obstruction. The types of inadvertent movements to be prevented or inhibited include lateral, twisting and rotational movements of the devices as well as movement of the devices further into or out from the body. In addition to the need to keep the devices from being inadvertently moved or damaged, certain of the skin penetrating devices, e.g. the pins used in orthopedic procedures, have sharp or pointed ends which, if contacted, can inflict injury upon the patient or a clinician.
As shown in
FIG. 1
, current practices which include the use of end caps on pins, do not provide an aseptic environment about the skin penetrating device nor do they function effectively as a buffer to protect the patient or clinician or to prevent movement of or damage to the pin. Thus, not only has there been a need to provide a sterile, aseptic environment about these skin penetrating devices where the devices pass though the skin of the patient, there also has been a need to buffer the skin penetrating devices against inadvertent movement and damage and patients and clinicians against accidental injury from the skin penetrating devices.
SUMMARY OF THE INVENTION
An aseptic protector of the present invention for skin penetrating devices includes a body of deformable material for accepting and encapsulating a protruding portion of a skin penetrating device, such as a pin or drain, from a location where the skin penetrating device protrudes from a skin surface to a location spaced outwardly from the skin surface. The body of deformable material functions as a buffer to protect the patient and clinicians from being injured on a skin penetrating device, such as a pin projecting from the patient and to protect the skin penetrating device from damage; and inhibits movement of the skin penetrating device.
In one embodiment of the invention, the body of deformable material has a longitudinally extending slit that permits the body of deformable material to be opened to receive a skin penetrating device and then closed to encapsulate all (such as when used with a pin) or a portion (such as when used with a drain) of the skin penetrating device protruding from the skin surface. In certain other embodiments, the body of deformable material is formed from a material or materials that cure(s), react(s) or solidifies to become a deformable plastic material or deformable resilient material after the aseptic protector has been applied to the skin penetrating device.
The body of deformable material includes an aseptic agent, preferably dispersed throughout the body of material, for contacting the skin surface and the skin penetrating device at the location where the skin penetrating device penetrates the skin surface to prevent, inhibit or arrest infection where the skin penetrating device penetrates the skin surface.
Preferably, the body of deformable material is encased within a tubular casing which may be provided with a skirt of flexible material to form an aseptic veil that surrounds the location where the skin penetrating device penetrates the skin surface. Where the body of deformable material is provided with a longitudinally extending slit, the tubular casing and skirt (if used) are also provided with a slit aligned with the slit in the body of deformable material and, preferably, provided with a means, such as but not limited to, an adhesively coated tab to close and seal the slit.


REFERENCES:
patent: 2069643 (1937-02-01), Burke
patent: 4089066 (1978-05-01), Dethman
patent: 4940046 (1990-07-01), Jacoby
patent: 5181914 (1993-01-01), Zook

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