Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-08-16
2002-12-24
Esquivel, Denise L. (Department: 3744)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S179000, C128SDIG008
Reexamination Certificate
active
06497683
ABSTRACT:
BACKGROUND
People with medical conditions which require indwelling catheters (usually venous), chronic or acute, for the delivery of drugs find that these catheters are uncomfortable and difficult to maintain. Indwelling catheters allow medical professionals to deliver intravenous medications continuously or repeatedly without repeatedly puncturing a vein. For example, cancer patients who require continuous infusions of chemotherapeutic agents receive their medications through indwelling catheters. For the medical professional, these indwelling catheters are a necessary convenience. For the patient, these catheters are uncomfortable, difficult to keep clean and sterile, and easy to pull out. They also represent a significant risk of life-threatening systemic infection.
Chronic indwelling catheters are surgically inserted into a vein through the patient's chest wall and are sutured to the patient's skin to prevent the insertion end from slipping out. These catheters can be in place for months or even years at a time. Typically, the external port end of the catheter is looped and secured to the skin with tape or is pinned to the patient's shirt, undergarment or bra. Movement and exercise are made difficult and uncomfortable if the clothing that the catheter is pinned to moves in relation to the insertion point of the catheter. Sometimes, the catheter is accidentally pulled out because the patient forgets to detach it from their clothing when undressing. Such problems occur even in acute such catheter use for a brief time.
Patients find that sleeping is especially uncomfortable with one of these catheters in place. These catheters are often pulled out during sleep. For example, if the catheter is pinned to a garment and the garment is not carefully adjusted when the patient rolls over during sleep, the catheter can easily be pulled out. Patients have difficulty sleeping because of worry over losing their catheters, soiling the bed sheets with blood, and risking infection. Patients who secure their catheters with tape may develop rashes or allergic reactions to the adhesive from the tape. Hirsute patients may be forced to either shave their chests or experience the pain of taped hair. Tape with less adhesive may lose its strength in hot weather when the patient perspires. Strongly adhesive surgical tape is uncomfortable to remove for daily treatments, especially after months of using tape in the same location.
The insertion point of these catheters is often the site of infection. Infection at the site of an indwelling catheter can follow the catheter directly into the bloodstream, creating life-threatening systemic infection. To prevent this serious infection, patients are charged with the responsibility of keeping the insertion point clean and sterile. The catheter itself must also be kept clean and the patient is often required to flush the catheter with saline. To further complicate the maintenance of these catheters, if the port end of the catheter falls below the insertion site or the level of the patient's heart, venous backflow or siphon effect can occur. This backflow seriously increases the risk of infection and clotting.
Often, whether these catheters are taped to the patient's chest or pinned to clothing, they are visible through shirts and clothing worn by the patient. The catheters are especially visible when taped to the most prominent area of the patient's pectoral muscle or pinned to the undergarment, shirt or bra. Patients find these catheters to be unsightly and embarrassing, a visible reminder of their illness.
OBJECTS
It is an object and feature of this invention, preferred forms of which are described in detail hereinafter, to overcome these disadvantages and drawbacks and to provide significant improvements in the care and maintenance of indwelling catheters not previously available.
It is an object and feature of this holding system to allow the external port end of the catheter to be suspended from the patient's neck. This holding system allows patients to wear their catheters like jewelry. Using this holding system, patients can wear their catheters discretely so that they hang midline on the chest, like jewelry, instead of being pinned prominently on the patient's undergarment, shirt or bra or taped prominently on the patient's pectoral muscle.
It is an object and feature of this invention to keep the port end from dropping below the level of the insertion end and the level of the patient's heart, and therefore reduce the risk of infection and clot-causing backflow or siphon effect. It is an object and feature of this invention to maintain the port end in a position carefully maintained by the length of the suspending element. It is also an object and feature of this invention to provide a sterile and sterilizable contact point between the catheter and holding system to help the patient fight infection.
This holding system, in a preferred form, also provides a holding system which does not require the use of uncomfortable, painful or rash-causing tape. It is an object and feature of this invention, to provide a holding system which allows patients to sleep without worrying so much that changing sleeping positions might rip the catheters from their chests. This holding system, in a preferred form, provides a holding system which allows patients to disrobe without worrying that changing clothes might rip the catheters from their chests.
It is an object and feature of this invention to provide a holding system which allows patients a greater range of motion. It is also an object and feature of this invention to reduce the patient's worry that exercise or movement will cause their catheter to be pulled out. It is a further object and feature of this invention to provide that advertising or decorative materials can be attached to the holding system. For example, children can affix stickers or other decorative materials to a preferred form of this holding system.
SUMMARY
According to a preferred embodiment of the present invention, this invention provides a holder system for comfortably and flexibly holding a port end of an indwelling catheter above a heart of a patient comprising: catheter cap means for releasably holding the port end of the indwelling catheter; hanging means for being suspended by a neck cord; wherein such hanging means comprises such catheter cap means and connection means for connecting with the neck cord. And it provides such system wherein such connector means comprises extension means, extending from a main body of such hanging means, for assisting connection with an eyeglass-holder neck cord. It also provides such a system wherein said connection means comprises an aperture and such system further comprises an adapter means for attaching with the neck cord and passing through such aperture means. Further it provides such system wherein such adapter means comprises a rigid bar portion suitable to pass through such aperture.
It further provides such system wherein such hanging means further comprises a divider means, between such aperture means and such catheter cap means, for assisting maintaining the sterility of the port end of the indwelling catheter. Further, it provides such system comprising suspending means for suspending such hanging means above the heart of the patient. It also provides such system wherein such suspending means comprises the neck cord. It also provides such system comprising a second such hanging means, wherein each such hanging means is suspended by the same such suspending means.
According to a preferred embodiment of the present invention, this invention provides a holder system for comfortably and flexibly holding a port end of an indwelling catheter above a heart of a patient comprising a catheter cap structured and arranged to releasably hold the port end of the indwelling catheter; a hanger structured and arranged to be suspended by a neck cord; wherein such hanger comprises: such catheter cap; and, at least one aperture structured and arranged to ho
Esquivel Denise L.
Norman Marc
Stoneman Martin L.
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