Surgery – Blood drawn and replaced or treated and returned to body – Constituent removed from blood and remainder returned to body
Reexamination Certificate
2001-03-16
2004-04-13
Basichas, Alfred (Department: 3749)
Surgery
Blood drawn and replaced or treated and returned to body
Constituent removed from blood and remainder returned to body
C604S250000
Reexamination Certificate
active
06719715
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to an apparatus for the treatment of a organic fluid wherein the apparatus provides a sealed system thereby reducing the possibility of contamination.
BACKGROUND OF THE INVENTION
Various treatments have been proposed for the treatment of mammalian blood ex vivo to condition the blood in some way before injecting the blood into a patient. Some procedures take blood from a patient, condition the blood, and then return the blood to the same patient continuously. These procedures contrast with procedures which require that the blood be taken from the, patient to be treated as a batch and then returned to the patient. In batch processes there is the possibility that the blood will be given to the wrong patient as well as the dangers inherent in transferring blood from one location to another. Also, batch treatments are potentially hazardous because of the risk of blood contamination during the process of conditioning the blood, because of the risk for cross contamination between batches, and also because of the potential for infecting the operator accidentally.
A blood treatment process using batch treatment techniques involves three main steps. Firstly, the blood is sourced either from a donor or from a patient, who will also be the patient receiving the conditioned blood. The blood may be mixed with an anticoagulant and the blood charge must then be transferred to apparatus used to condition the charge. In a second step, the blood is conditioned. Finally, in a third step, the conditioned charge has to be collected and prepared for injection into the patient. These steps may involve the use of needles (sharps), tubing, valves, syringes and ancillary parts and connectors. At every stage it is important to minimize risk so that the charge is moved and treated without contamination, and so that none of the charge comes into contact with the operator running the procedure and so that none of the charge comes into contact with non-disposable parts of the apparatus.
Accordingly, it is among the objects of the present invention to provide a process and apparatus for receiving a blood charge, conditioning the charge, and preparing the conditioned charge for injecting into a patient while minimizing the risk of contamination and spillage.
It is another object of the present invention to provide a needle assembly wherein a first end of a needle may be inserted intramuscularly while a second end in fluid communication with the first end projects beyond the patient's tissue for connection to a fluid delivery or removal assembly and the second end being shielded.
It is another object of the present invention to provide a heat sealing for a thermoplastic medical tubing, thereby providing a sealed system and thus reducing the risk of contamination of the blood charge, reducing the risk of cross contamination between blood charges, and reducing the risk of the charge contacting the operator.
SUMMARY OF THE INVENTION
In accordance with one aspect of the present invention, a closed system for removing a organic fluid from a patient, conditioning the organic fluid, and returning the organic fluid to the patient is described. The system includes an apparatus for removing the organic fluid from the patient, a container for receiving the removed organic fluid, a cabinet for conditioning the organic fluid in the container, and an apparatus for delivering the conditioned organic fluid to the patient, wherein the system prevents contamination between removal of the organic fluid from the patient and delivery of the organic fluid back to the patient.
In accordance with another aspect of the present invention, an apparatus for conditioning of a organic fluid includes a cabinet for conditioning the organic fluid, an input system, and an output system. The cabinet includes a removable container for receiving the organic fluid for conditioning treatment thereof. The container includes an input port and an output port. The input system for transporting said organic fluid through an input tube from a source to said input port of said container, wherein said input tube provides sealed transportation from said fluid source to said input port of said container. The output system including a syringe for receiving said organic fluid from said output port of said container, wherein an output tube connects said output port to said syringe, the output system further including a heat sealing device disposed between said output port and said syringe for substantially severing and sealing said tubing.
In accordance with a further aspect of the present invention, a method for removing a organic fluid from a patient, conditioning the organic fluid, and returning the organic fluid to the patient without contamination includes the steps of:
removing the organic fluid from the patient;
receiving the removed organic fluid in a container;
conditioning the organic fluid in the container; and
delivering the conditioned organic fluid to the patient, wherein contamination of the organic fluid, contamination of the conditioning apparatus, and contamination of the operator are prevented between removal of the organic fluid from the patient and delivery of the organic fluid back to the patient.
In yet another embodiment there is provided a method and device for heat sealing medical tubing, thereby preventing contamination of the fluid within the tubing, potential contamination to an operator, or contamination of reusable parts of the device. In addition, there is provided a device for shielding the non-sterilized heat sealed tubing ends thereby protecting the operator from contamination from the non-sterile surfaces.
In accordance with another aspect of the present invention, a needle assembly for delivering or removing multiple fluids includes a needle device and a first fluid delivery or removal assembly. The needle device includes a first body having a needle with a first tissue penetrating end, a second fluid receiving end in fluid communication with the first tissue penetrating end, and a chamber which surrounds the second end. The first fluid delivery or removal assembly has a fluid chamber and is configured to be received in the chamber of the needle device with the second end penetrating into the fluid chamber.
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Dayman Jeffrey George
Moore Paul George Andrew
Newman Duncan Arthur
Worona Taras
Basichas Alfred
Burns Doane , Swecker, Mathis LLP
Vasogen Ireland Limited
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