Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-05-08
2002-10-08
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C514S035000
Reexamination Certificate
active
06461331
ABSTRACT:
FIELD OF THE INVENTION
This invention relates to infusion of small molecule insulin mimetic materials, and in particular embodiments, to continuous, near continuous, intermittent and or basal/bolus infusion of the small molecule mimetic materials for the control of diabetes.
BACKGROUND OF THE INVENTION
Currently, insulin must be provided to people with Type 1 and many with Type 2 diabetes (approximately 40% of patients with Type 2 diabetes use insulin). Traditionally, since it cannot be taken orally, insulin has been injected with a syringe. More recently, use of external infusion pump therapy has been increasing, especially for delivering insulin for diabetics using devices worn on a belt, in a pocket, or the like, with the insulin delivered via a catheter with a percutaneous needle or cannula placed in the subcutaneous tissue. For example, as of 1995, less than 5% of Type I diabetics in the United States were using pump therapy. There are now about 7% of the currently over 900,000 Type I diabetics in the U.S. using insulin pump therapy, and the percentage is now growing at an absolute rate of over 2% each year. Moreover, the number of Type I diabetics is growing at 3% or more per year. In addition, growing numbers of insulin using Type II diabetics are also using external insulin infusion pumps. Physicians have recognized that continuous infusion provides greater control of a diabetic's condition, and are also increasingly prescribing it for patients.
However, administration of insulin by continuous infusion may not resolve all of the individual's needs and could be ineffective for treating some individuals, for example those individuals who are insulin resistant with Type II diabetes. Thus, alternatives to insulin therapy have been sought. Traditionally, oral medications have been used to treat some of the symptoms, but there have been many reports of adverse side-effects and even death. Also, delivery of medication orally suffers from several drawbacks, including, but not limited to, destruction of the medication and delay times until the medication reaches the blood stream of the individual. Therefore, there is the need for alternative treatment regimens that overcome the drawbacks of oral medications and the resistance of some individuals to insulin treatment.
SUMMARY OF THE DISCLOSURE
It is an object of an embodiment of the present invention to provide an a device and method of infusing small molecule insulin mimetic materials using continuous, near continuous, intermittent and or basal/bolus infusion, which obviates for practical purposes, the above mentioned limitations.
According to an embodiment of the invention, a medication delivery device for delivering a small molecule insulin mimetic material to a body of an individual includes a housing, a reservoir and a controller. The housing contains a driving mechanism, and the reservoir is coupled to the driving mechanism in the housing for holding the small molecule insulin mimetic material to be infused into the body of the individual. The controller controls the driving mechanism to expel the small molecule insulin mimetic material from the reservoir into the body of the individual. In preferred embodiments, the medication delivery device is an infusion pump. In particular embodiments, the driving mechanism is a syringe type drive actuator, while in other embodiments it is a gas generator. Alternatively, the small molecule insulin mimetic material is electrically charged and delivered by iontophoresis or passive diffusion through the skin. Preferred embodiments control the driving mechanism to infuse the small molecule insulin mimetic material in a continuous, near-continuous, intermittent and pulsatile manner. Further embodiments control the driving mechanism to deliver discrete, user settable boluses.
In preferred embodiments, the small molecule insulin mimetic material is L-783,281. In other embodiments, the small molecule insulin mimetic material is an analog of L-783,281. The small molecule insulin mimetic material may be infused with at least one additional component such as insulin, insulin analogs and insulin related peptides. In preferred embodiments, the small molecule insulin mimetic material binds to &bgr; sub-units of an insulin receptor site. In other embodiments, the small molecule insulin mimetic material binds to &agr; sub-units of an insulin receptor site. Alternatively, the small molecule insulin mimetic material is a trans-membrane insulin mimetic material that binds to at least one &bgr; sub-unit and at least one &agr; sub-unit of an insulin receptor site.
In still other embodiments, the medication delivery device further includes a display and a processor. The processor is connected to the controller and the display, and the processor tracks the infusion and displays information about the infusion the display. In further embodiments, the medication delivery device includes an input from a sensor sensitive to glucose levels in the body, and the input from the sensor is used to control the controller of the medication delivery device. In alternative embodiments, the medication delivery device further includes an input from a sensor sensitive to small molecule insulin mimetic material levels in the body, and the input from the sensor is used to control the controller of the medication delivery device.
In yet other embodiments, the medication delivery device further includes a memory device for storing information about the infusion of the small molecule insulin mimetic material for later recall. In other embodiments, the controller is programmable and/or remotely programmable by a remote programmer.
Other embodiments are directed to methods of infusing a small molecule insulin mimetic material into the body of an individual.
Other features and advantages of the invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings which illustrate, by way of example, various features of embodiments of the invention.
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Zhang, Bei et al., “Discovery of a Small Molecule Insulin Mimetic with Antidiabetic Activity in Mice”, Science, vol. 284, pp. 974-977, XP-002145727, (May 1999).
Fastovsky Leonid M
Gates & Cooper LLP
MiniMed Inc.
Walberg Teresa
LandOfFree
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