Methods and implantable devices and systems for long term delivery of a pharmaceutical agent

Abstract

Implantable devices and osmotic pump and catheter systems for delivering a pharmaceutical agent to a patient at selectable rates include an impermeable pump housing and a moveable partition disposed within the housing, the partition dividing the housing into an osmotic driving compartment having an open end and a pharmaceutical agent compartment having a delivery orifice. A plurality of semi permeable membranes may be disposed in the open end of the osmotic driving compartment and a number of impermeable barriers may seal selected ones of the plurality of semi permeable membranes from the patient until breached. Breaching one or more of the impermeable barriers increases the surface area of semi permeable membrane exposed to the patient and controllably increases the delivery rate of the pharmaceutical agent through the delivery orifice and catheter. Each of the plurality of semi permeable membranes may have a selected surface area, composition and / or thickness, to allow a fine-grained control over the infusion rate while the pump is implanted in the patient.

Description

[0001] 1. Field of the Invention[0002] This invention relates to the field of drug delivery. In particular, the present invention relates to methods, devices and systems adapted to sub-chronic implantation (less than or equal to 12 months and typically less or equal to about 6 months) in the patient's body to deliver a drug or other pharmaceutical agent at a sustained rate.[0003] 2. Description of the Related Art[0004] Since the beginning of modem medicine, drugs have been administered orally. Patients have taken pills as recommended by their physician. The pills must pass through the digestive system and then the liver before they reach their intended delivery site (e.g., the vascular system). The actions of the digestive tract and the liver often reduce the efficacy of medication; furthermore, medications delivered systemically sometimes cause undesirable side effects. Over the course of the past few decades, drug delivery technology and administration has evolved from oral delive...

AI Technical Summary

Benefits of technology

[0010] In accordance with the above-described objects and those that will be mentioned and will become apparent below, an implantable osmotic pump for delivering a pharmaceutical agent to a patient comprises a pump housing; a moveable partition disposed within the housing, the partition dividing the housing into an osmotic driving compartment having an open end and a pharmaceutical agent compartment having a delivery orifice; a first semi permeable membrane disposed in the open end of the osmotic driving compartment, the first semi permeable membrane being exposed to the patient; a second semi permeable membrane disposed in the open end of the osmotic driving compartment, and a first impermeable barrier disposed over the second semi permeable membrane, the second semi permeable membrane being sealed from the patient until the first barrier is breached, wherein breaching the first barrier increases the surface area of semi permeable membrane exposed to the patient and increases a delivery rate of the pharmaceutical agent through the delivery orifice.

[0011] According to further embodiments, the first impermeable barrier may include titanium and / or stainless steel. A saturated solution including NaCl may be present between the first impermeable barrier and the second semi permeable membrane. The first and second semi permeable membranes may the same composition and / or may have the same thickness. Alternatively, the first and second semi permeable membranes may have mutually different compositions and / or mutually different thickness. The pump may further include a third semi permeable member, and a second impermeable barrier may be nested within the first impermeable barrier. The second impermeable barrier may be disposed over the third semi permeable membrane and may seal the third semi permeable membrane from the patient until the second impermeable barrier is breached. Breaching the second barrier increases the surface area of semi permeable membrane exposed to the patient and increases the delivery rate of the pharmaceutical agent through the delivery orifice.

Problems solved by technology

The actions of the digestive tract and the liver often reduce the efficacy of medication; furthermore, medications delivered systemically sometimes cause undesirable side effects.

Unfortunately, IV administration requires the use of a percutaneous catheter or needle to deliver the drug to the vein.

Infection is such a significant risk that IV administration is often limited to a number of weeks, at most.

Two problems associated with such 1970s and 1980s vintage constant rate and programmable rate infusion pumps relate to their size and their cost.

The current implantable pumps must be implanted in the Operating Room under general anesthesia, which further increases costs, as well as the risk, and discomfort to the patient.

The size and cost of such pumps has proven to be a substantial barrier to their use, and they are rarely used to deliver medication.

An added drawback of phase-change and peristaltic pumps is that they must be refilled with drug every 3-8 weeks.

Refills constitute an added burden to the caregiver, and add further costs to an already overburdened healthcare system.

The burden associated with such refills, therefore, further limits the use of phase-change and peristaltic pumps.

A limitation of the osmotic pump disclosed in the above-identified patent, however, is that its infusion rate cannot be adjusted once it is implanted.

The system disclosed in the above-identified patent does not allow a rate increase after implantation, so the physician must either replace the current implant or implant an additional pump to replace or supplement the system.

However, the prospect of yet another surgical procedure may cause many patients to forego the potential benefits of the larger dose and may also cause their physicians to advise against the initial procedure altogether.

For such patients for whom the implantable pump no longer delivers an adequate dosage of medication, the physician may opt to supplement the dosage delivered by the implantable device by other means, such as by intravenous delivery, in which case the same side effects discussed above may again occur.

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