Body access system

Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...

Reexamination Certificate

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Details

C604S164090, C604S272000

Reexamination Certificate

active

06296624

ABSTRACT:

FIELD OF THE INVENTION
The present invention relates to an improved body access system for the safe collection of samples and administration of fluids.
BACKGROUND OF THE INVENTION
The need for protection from exposure to needle sticks has been the impetus to the development of needle guards and needle protectors. Furthermore, an increased awareness of transmission of infections from exposure to body fluids or other samples has led to the development of improved means to limit exposure to samples collected.
An example of both a risk of sustaining a needle stick and also exposure to collected samples is the current procedure for the drawing of spinal fluid during a spinal tap. Typically, a needle with a stylet is inserted between the appropriate vertebrae, the stylet is removed and multiple vials are handled during the procedure. There is risk of breakage and leakage and consequent exposure of personnel to the samples collected. Also, when the needle or stylet is withdrawn during and after the procedure, there is risk of being stuck by either the needle or the stylet.
A number of systems have been devised to protect individuals from needle sticks while using syringes and angiocatheters. However, users of needles for other purposes, such as spinal taps, still have no protective devices suitable for their needs.
In U.S. Pat. No. 5,396,899, Strittmatter disclosed an apparatus to limit leakage when spinal fluid is collected.
In application Ser. No. 08/795,342 means were introduced to limit exposure to needle sticks, stylet sticks, and spinal fluid samples during the performance of a spinal tap.
The means introduced in application Ser. No. 08/795,342 for spinal taps are applicable for the collection of other body samples.
SUMMARY OF THE INVENTION
This application introduces means for the safe collection of spinal fluid and other body samples. The means introduced in application Ser. No. 08/795,342 are illustrated with additional examples in the figures. Furthermore, modifications to the means introduced in application Ser. No. 08/795,342 are introduced to demonstrate the utility of the invention in the collection of other body samples, such as, for example, blood samples and tissue biopsies.
The invention relates to the introduction of a system that decreases exposure to needle sticks and stylet sticks by capturing the needle and stylet within a cylinder as they are withdrawn from the body. The needle unit of the invention comprises a needle and a hub and, optionallly, may also comprise a stylet. The needle may be a solid needle, such as ones used in an angiocatheter, or a hollow needle, such as those used for spinal taps and tissue biopsies. A hollow needle may also contain a stylet, such as, for example, a conventional spinal tap stylet or a tissue biopsy stylet. Furthermore, as is the case in currently used means for tissue biopsies, the needle may be a cutting needle and the stylet a device to passively retain the cut tissue, or the stylet itself may be a cutting stylet.
It is an object of the present invention to provide means for limiting exposure to needle sticks from spinal tap needles during and after the performance of a spinal tap. It is another object of the present invention to provide means for limiting exposure to sticks from spinal tap stylets during and after the performance of a spinal tap.
It is a further object of the present invention to provide means for limiting exposure to spinal fluid samples during and after the performance of a spinal tap.
It is a further object of the invention to introduce means to limit exposure to needles used in obtaining body fluid and tissue samples.
It is yet another object of the invention to introduce means to limit user exposure to stylets used in body access procedures.
It is still another object of the invention to limit exposure to body fluid and tissue samples.
A body access system is disclosed which provides for the safe collection of samples and the safe administration of fluids. The system provides protection from inadvertent needle sticks in the collection of samples. The system can be utilized not only for the collection of blood but also for the collection of other body fluids and biopsies, such as, for example, spinal taps, liver biopsies, renal biopsies, pleural biopsies, pericardiocentesis, thoracocentesis, paracentesis, and dialysis. The system also provides protection from inadvertent exposure to the samples themselves, such as, for example, blood and spinal fluid.
This invention proposes the use of a protective cylinder into which a needle can be withdrawn. The needle hub is engaged and the needle is then withdrawn into the cylinder or the cylinder is pulled over the needle.
It is an object of this invention to introduce a body access system to protect a user from both inadvertent needle sticks and from inadvertent exposure to body samples.
It is another object of this invention to introduce a protective cylinder into which a needle can be withdrawn.
It is a further object of this invention to introduce needle hub engagement means that are engaged for the subsequent withdrawal of said needles into protective cylinders.
It is an object of this invention to introduce a protective sample collection device to prevent a user from being exposed to the sample collected.
It is another object of this invention to introduce a protective sample collection device to prevent a user from being exposed to the sample collected by gravity flow.
It is a further object of this invention to introduce a protective sample collection device to prevent a user from being exposed to the sample collected by a vacuum.


REFERENCES:
patent: 5466225 (1995-11-01), Davis et al.

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