Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
1999-06-16
2001-08-07
Seidel, Richard K. (Department: 3763)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C604S131000
Reexamination Certificate
active
06270481
ABSTRACT:
TECHNICAL FIELD
The present invention relates generally to a system for delivering medicine to a patient, and more particularly, to a system having a patient-controlled infusion pump which delivers medicine to an internal treatment site.
BACKGROUND OF THE INVENTION
Pain management is an important aspect of post-operative recovery from surgery. Pain management usually begins immediately following the surgical procedure with the administration of narcotics or other pain control medications to the patient while the patient is under the direct supervision of the health care provider. The pain control medications are most commonly administered either orally or by injection.
The proliferation of less-invasive arthroscopic techniques for the surgical repair of many joint or soft tissue injuries and ailments has significantly reduced post-operative recovery times and the attendant pain experienced by the patient. The current trend toward arthroscopic techniques frequently enables surgical procedures to be performed on an outpatient basis or with shortened post-operative hospital stays. As a result, the bulk of the post-operative recovery time is spent in the home or even in the workplace. One goal of home recovery is to phase the patient back into routine physical activities relatively quickly as a means of shortening the post-operative recovery time.
Since the patient is generally not under the direct supervision of the health care provider when in the home or workplace, the responsibility for administering pain control medications falls on the patient in these environments. Nearly all self-administered pain control medications are oral medications because most individuals lack the requisite knowledge, skill, and experience to self-administer pain control medications by injection. Unfortunately, however, pain control medications administered orally are transported throughout the body and correspondingly affect the entire body, often causing undesirable side effects such as drowsiness, disorientation, nausea, constipation or vomiting. In contrast, injected pain control medications can be administered more locally than orally administered medications, thereby frequently avoiding the undesirable side effects of oral medications. In addition, injected pain control medications reach the treatment site more rapidly and in greater concentrations than oral medications, rendering injected pain control medications a more effective pain control therapy. Although advantageous, injected pain care medications are nevertheless not feasible for most individuals not under the direct supervision of health care providers for the reasons set forth above.
The present invention recognizes a need for a device which enables the patient to effectively self-administer medication by injection even when the patient lacks the requisite knowledge, skill or experience to perform injections. Accordingly, it is an object of the present invention to provide a medication delivery system, wherein operation of the system is controlled by the patient. More particularly, it is an object of the present invention to provide such a medication delivery system, wherein the patient controls the injection of the medication directly into a treatment site of the patient. It is another object of the present invention to provide such a medication delivery system, wherein the system can be effectively operated by a patient lacking any specific medical knowledge, skill or experience in performing injections. It is still another object of the present invention to provide such a medication delivery system, wherein the system is fully self-contained and portable so that the system can be worn by the patient during routine physical activity. It is yet another object of the present invention to provide such a medication delivery system, wherein the system may be cost-effectively disposed after a single patient use.
These objects and others are accomplished in accordance with the invention described hereafter.
SUMMARY OF THE INVENTION
The present invention is a portable, patient-controlled medication delivery system which enables a patient to self-administer a treatment fluid, preferably in the form of a liquid medicine. The medication delivery system includes an infusion pump, a catheter assembly and an extension tubing set. The infusion pump retains the total charge of the treatment fluid comprising a plurality of full dosages and provides a drive mechanism for delivering one or more dosages of the treatment fluid to a treatment site in the patient. The catheter assembly includes a medicine catheter having one free end which penetrates directly through an opening formed in the skin into the internal treatment site of the patient. The extension tubing set includes an extension tube having one end which is coupled to the opposite free end of the medicine catheter by means of a catheter connector. The extension tube has an opposite end which is coupled to the infusion pump to provide fluid communication between the infusion pump and the treatment site. The extension tube preferably has a substantially larger flow cross-section and an equal or substantially longer length than the medicine catheter.
The infusion pump is a manually powered pump which is fully enclosed within a housing. The housing is provided with a mount which enables a patient to wear the infusion pump as a portable, self-contained unit. The infusion pump includes a fluid reservoir, a dosage chamber, a displacement piston displacable within the dosage chamber and a flowpath providing fluid communication between the fluid reservoir and the dosage chamber. An elastic member is also positioned in the infusion pump to exert a displacement force on the displacement piston. The elastic member is alternately transitionable between a more stressed position and a less stressed position. The elastic member elastically displaces the displacement piston in a first elastic displacement direction to expand the dosage chamber and draw the treatment fluid from the fluid reservoir into the dosage chamber through the flowpath when the elastic member transitions from the more stressed position to the less stressed position. The displacement piston is manually displaced in a second manual displacement direction substantially opposite the first elastic displacement direction to contract the dosage chamber and discharge the treatment fluid from the dosage chamber to the treatment site when the elastic member transitions from the less stressed position to the more stressed position.
The fluid reservoir is preferably a fluid-tight bladder having a fluid capacity substantially greater than the fluid capacity of the dosage chamber. In particular, the fluid reservoir preferably has a capacity for a plurality of dosages of the treatment fluid, whereas the dosage chamber preferably has a capacity for only one dosage of the treatment fluid. The elastic member is preferably a coiled spring connected to the displacement piston by engagement with a manually displacable actuator button which in turn engages the displacement piston. The infusion pump is also provided with a valve positioned in the flowpath which enables treatment fluid flow from the fluid reservoir to the dosage chamber while substantially preventing treatment fluid flow from the dosage chamber to the fluid reservoir.
In operation, the medicine catheter is place in the internal treatment site. The fluid reservoir of the infusion pump is filled with the total charge of the treatment fluid which comprises a plurality of full treatment fluid dosages. The infusion pump is mounted on the body of the patient and the medicine catheter is placed in fluid communication with the infusion pump by means of the extension tube and the catheter connector. A suction force is then created in the dosage chamber of the infusion pump by means of the elastic member to draw a single full dosage of the treatment fluid into the dosage chamber from the fluid reservoir via the flowpath. In particular, the suction force is created when the elastic member transitions fr
Mason Bradley R.
Mason Jeffrey T.
Breg, Inc.
Brown Rodney F.
Maynard Jennifer
Seidel Richard K.
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