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Implantable system with drug-eluting cells for on-demand local drug delivery

a technology of drug-eluting cells and implantable systems, which is applied in the field of implantable systems, can solve problems such as systemic administration and systemic administration can be deleterious, and reduce the potency of drugs

Inactive Publication Date: 2005-06-30
MEDTRONIC INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0013] Thus, an object of the present invention is to provide a system and method for the treatment (including prevention) of coronary artery disease, for example, by producing and delivering locally a therapeutic agent, such as an anticoagulant. Significantly, the local dosage can be controlled and provided on demand without worrying about the systemic effects. Furthermore, the local dosage can be administered prior to significant physiological damage occurs to the patient.

Problems solved by technology

Systemically administered drugs (e.g., anticoagulants) are also commonly used, however, such drugs become diluted, which can reduce their potency by the time they reach the remote site.
Furthermore, systemic administration can be deleterious because it can lead to complications as a result of the high dosages required upon administration to allow for dilution that occurs during transport to the remote site.

Method used

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  • Implantable system with drug-eluting cells for on-demand local drug delivery

Examples

Experimental program
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Effect test

— example 1

Cell Culture Studies—Example 1

[0092] Human coronary artery endothelial cells (Clonetics, San Diego, Calif.) were seeded in 24 well tissue culture plates at 1×104 cells / cm2 (1.5 mL total volume) and grown in defined media as supplied by Clonetics. The cells were incubated at 37° C., 5% CO2 for up to four days. The media was not changed on the cells during the course of the experiment. Supernatants from duplicate wells were withdrawn on days 2, 3, and 4 post-seeding. In addition, cells plus supernatants from a second set of samples were harvested from duplicate wells on days 2, 3, and 4 post-seeding. Samples were stored at −85° C. until assayed. The ELISA assay was performed on the test samples and on controls following the procedure outlined by the manufacturer (American Diagnostica, Inc.) The standard curve was generated using control plasma A, t-PA antigen control plasma set 2 (Product #275, American Diagnostica, Inc.). The test samples were assayed undiluted (20 μL assay volume). ...

— example 2

Cell Culture Studies—Example 2

[0093] This experiment was performed similarly to the first experiment with the following changes. In the first part of the experiment, cells were seeded at three different densities (1×104, 2×104, 4×104) in 0.5 mL total volume per well, and the cell supernatants were collected on day 2 and day 3 post seeding. In the second part of the experiment, cells were seeded at 2×104 cells / cm2 and one group was stimulated once (on day 2 post seeding) and a second group was stimulated two times (once on day 2 and once on day 3 post seeding). The stimulation level was 55V (350-440 mA) for 5 minutes and supernatants were collected 15 minutes after stimulation. The following tables contain the data that was obtained from this experiment. The data confirms what was observed in the first experiment—that t-PA production / release is correlated with cell number and with cell growth. Although this data from the stimulated samples suggests that electrical stimulation at 55 v...

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Abstract

An implantable system that includes a carrier and eukaryotic cells, which produce and release a therapeutic agent, and a stimulating element for stimulating the release of the therapeutic agent. The system can also include a sensing element for monitoring a physiological condition and triggering the stimulating element to stimulate the delivery device to release the therapeutic agent. Alternatively, the patient in which the system is implanted can activate the stimulating element to release the therapeutic agent.

Description

[0001] This application is a Continuation-In-Part of U.S. patent application Ser. No. 09 / 070,480 filed 30 Apr. 1998, which is incorporated by reference.FIELD OF THE INVENTION [0002] The present invention relates to implantable systems that include medical devices (e.g., stents, vascular grafts, stent grafts) that function as a carrier for eukaryotic cells (e.g., genetically engineered endothelial cells). Such cells are capable of producing and releasing a therapeutic agent (e.g., tissue-type Plasminogen Activator) for on-demand localized treatment of conditions such as coronary artery disease. The cells or the device carrying them release the therapeutic agent upon the application of a stimulus (e.g., electrical stimulus). BACKGROUND OF THE INVENTION [0003] Coronary Artery Disease (CAD) affects 1.5 million people in the USA annually. About 10% of these patients die within the first year and the rest suffer from myocardial infarction and develop related symptoms, such as arrhythmias,...

Claims

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Application Information

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IPC IPC(8): A61F2/00A61F2/02A61F2/06A61F2/82A61F2/88A61K9/00A61K35/12A61K38/00A61K38/48A61K38/49A61K48/00A61L27/38A61L27/54A61L29/00A61L29/16A61L31/00A61L31/10A61L31/16A61N1/365C12N5/071
CPCA61F2/02C12N5/069A61F2/82A61F2/88A61F2250/0001A61F2250/0067A61K9/0009A61K9/0024A61K38/4866A61K38/49A61K48/00A61K2035/126A61L27/3804A61L27/3808A61L27/3843A61L27/54A61L29/005A61L29/16A61L31/005A61L31/10A61L31/16A61L2300/00A61L2300/22A61L2300/252A61L2300/254A61L2300/414A61L2300/416A61L2300/42A61L2300/602A61L2300/64A61N1/36542A61F2/06
Inventor SOYKAN, ORHANDONOVAN, MAURA G.
Owner MEDTRONIC INC
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