Surgery – Means for introducing or removing material from body for... – Material introduced into and removed from body through...
Reexamination Certificate
2000-09-13
2003-06-03
Tanner, Harry B. (Department: 3744)
Surgery
Means for introducing or removing material from body for...
Material introduced into and removed from body through...
C604S033000
Reexamination Certificate
active
06572579
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
It has long been common practice for practitioners using a medical device to customize it on site. For example, practitioners may take a straight-ended catheter from stock and reshape it with the fingers, to achieve greater efficacy in a particular task. The present invention relates to a class of devices supplemented by computer supported designed-in variability, so that the user can make choices more accurately aimed at successfully accomplishing particular results.
The present invention relates to the field of delivery of materials into a patient, particularly at local sites within a patient using externally delivered devices to carry the materials to the desired site. The invention also relates to systems and processes for material delivery (especially pharmacologically active, view enhancing active or treatment active materials) to patients under Magnetic Resonance Imaging procedures.
2. Background of the Art
It is increasingly common and even necessary to administer a drug or other desired material to a carefully targeted part of the body. Currently such material is most often a solution or suspension of molecules, but in the future may include a suspension of nanoscopic devices. This targeted delivery is in contrast to conventional delivery methods where a drug is inserted into the bloodstream and treatment relies upon some of the drug finding the appropriate target. Targeted delivery has multiple advantages, when it can be done effectively. Much less of the drug is needed, which represents a double gain. Many drugs are costly, so the delivery of drugs in amounts greater than are needed for treating a specific area of a patient is wasteful and expensive. It is rare that any drug is wholly without negative effects (e.g., side effects, with reference to the desired result of the primary drug). In some instances, these adverse side effects arise only where the drug reaches a specific tissue. Therefore, restricting the drug to a target that does not include tissue that can be damaged avoids side effects completely. Even where that degree of precision in delivery is not possible, the side effects may be far more acceptable if limited to a small region around the target, with reduced impact on the body at large, while delivering the desired result on the target tissue at full strength. Even where the side effects are not directly life-threatening, it can be important to avoid them. For example, it is desirable to keep cancer chemotherapy drugs from the sites where they cause nausea and hair loss. That practice would be good both for patient morale and for patient persistence in taking the drug.
Some drug therapies use very strong or even toxic materials in the treatment, and even cryogenic treatments can cause collateral damage as the cryogenic material contacts non-targeted tissue. Hormonal treatments, where picogram delivery volumes are used because of the strength or activity of the material delivered and/or the limited area of treatment desired, can cause significant collateral damage when inappropriately delivered. This is particularly true in intraparenchymal procedures and other intracranial procedures where collateral damage, even on a small physical scale, can be very serious.
The majority of directed drug delivery systems tend to be essentially universal systems (intravenous or oral), indiscriminate local application (transdermnal), or indiscriminate quasi-local (infusion from a catheter). Even the most advanced designs for MRI observable drug delivery as disclosed in U.S. Pat. Nos. 6,026,316; and 5,964,705 can only properly position the catheter, but do not provide specific structures that can adjust the rate and position of drug delivery from the catheter other than by standard fluid pressure control. Many different functions and controls are desirable in drug delivery systems, particularly with respect to the rate and direction of drug delivery. It would be a poor operational protocol to require essentially random direction positioning on a catheter of delivery outlets for a drug, cell culture, nanoscopic devices or other material, or require increased volumetric delivery, solely because the catheter could not be positioned with the outlets in an optimized position for desired delivery.
There are many different forms of drug delivery rate controls used in the medical field, both with intravenous, transdermal, and other forms of delivery. For example, U.S. Pat. No. 6,029,083 describes a “fail-safe” iontophoretic drug delivery apparatus and a corresponding method is provided. The apparatus includes a current generating circuit for sending a current through a patch, error detection circuitry, and a control circuit. The control circuit controls the current generating circuit. When errors are detected in the apparatus, the control circuit stops the current and disables itself.
U.S. Pat. No. 6,017,318 describes a feedback controlled drug delivery system that includes the automated sampling and analysis of a patient sample and dosing the patient based on the analysis. Automated sampling may be performed by direct analysis of the patient sample, such as for the measurement of a blood sample coagulation state or a glucose level. The drug delivery system includes a sample set that has a bi-directional patient tube that allows for delivery of the patient sample to an analyzer, and at another time, the infusion of a therapeutic drug. A controller receives a measurement from the analyzer, and based on that measurement, adjusts the delivery of the therapeutic fluid. The sample set has a quick-clear Leur fitting that allows for more effectively clearing a first fluid from a Leur fitting when starting a second fluid. The system also has a reagent cassette holder that protects, using a foam gasket, a reagent on a sample slide. Further, the system provides an interlock apparatus that assures a sample tube is occluded by either or both a slide clamp and by a platen arm compressing the sample tube to a peristaltic pump.
U.S. Pat. No. 6,007,518 describes a fluid delivery apparatus comprising:
(a) a fluid delivery assembly having an outlet for delivering fluid from the apparatus, said fluid delivery assembly including:
(i) a base;
(ii) means defining a conformable ullage overlaying said base for forming in conjunction therewith a reservoir having an outlet in communication with said outlet of said fluid delivery assembly;
(iii) a cover assembly connected to said base, one of said cover assembly and said base having a receiving chamber interconnected with said reservoir; and
(iv) a stored energy means for exerting forces on said means defining a conformable ullage, said stored energy means comprising at least one distensible membrane superimposed over said means defining a conformable ullage, said membrane being distensible by forces imparted thereon by said means defining a conformable ullage in response to fluids introduced into said reservoir, said forces establishing internal stresses within said distensible membrane, said stresses tending to return said distensible membrane toward a less distended configuration, said distensible membrane being generally conformable to the shape of said means defining a conformable ullage as said membrane is being distended thereby and also being generally conformable to the shape of said means defining a conformable ullage as said distensible membrane tends to return to said less distended configuration; and
(b) a fill assembly interconnected with said fluid delivery assembly for filling said reservoir.
U.S. Pat. No. 5,997,527 describes a delivery device having a first chamber containing an osmotic agent, a membrane forming a wall of the first chamber through which fluid is imbibed by osmosis, a second chamber containing a beneficial agent to be delivered, and a moveable piston separating the two chambers. In fluid communication with the second chamber is an orifice which comprises a slit valve. In the presence of pressure, the beneficial agent pushes through the slit, opening up a channel for
Poston Timothy
Raghavan Raghu
Viswanathan Raju R.
Image-Guided Neurologics Inc.
Mark A. Litman & Assoc. P.A.
Tanner Harry B.
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