Adhesion promoting temporary mask for coated surfaces

a technology of adhesive and surface, applied in the field of tissue-supporting medical devices, can solve the problems of increasing trauma and risk to patients, reducing the mechanical expansion properties of the stent, and increasing the risk of restenosis, and achieving the effect of reducing the effective wall thickness of the sten

Inactive Publication Date: 2010-06-24
CORDIS CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0019]In view of the drawbacks of the prior art, it would be advantageous to provide a stent capable of delivering a relatively large volume of a beneficial agent to a traumatized site in a vessel lumen while avoiding the numerous potential problems associated with surface coatings containing beneficial agents, without increasing the effective wall thickness of the stent, and without adversely impacting the mechanical expansion properties of the stent.
[0020]It would further be advantageous to provide a tissue supporting device with different beneficial agents provided in different holes

Problems solved by technology

Restenosis is a major complication that may arise following vascular interventions such as angioplasty and the implantation of stents.
To treat this condition, additional revascularization procedures are frequently required, thereby increasing trauma and risk to the patient.
The patent offers detailed descriptions of methods for coating stent surfaces, such as spraying and dipping, as well as the desired character of the coating itself: it should “coat the stent smoothly and evenly” and “provide a uniform, predictable, prolonged release of the anti-angiogenic factor.” Surface coatings, however, may provide little actual control over the release kinetics of beneficial agents.
However, the increased coating thickness results in an increased overall thickness of the stent wall.
This is undesirable for a number of reasons, including potential increased trauma to the vessel lumen during implantation, reduced flow cross-section of the lumen after implantation, and increased vulnerability of the coating to mechanical failure or damage during expansion and implantation.
Coating thickness is one of several factors that affect the release kinetics of the beneficial agent, and limitations on thickness thereby limit the range of release rates, durations, and the like that may be achieved.
Surface coatings may also limit the delivery of multiple drugs from a stent.
For example, if multiple drugs were to be released from a surface coating, the release rates, delive

Method used

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  • Adhesion promoting temporary mask for coated surfaces
  • Adhesion promoting temporary mask for coated surfaces
  • Adhesion promoting temporary mask for coated surfaces

Examples

Experimental program
Comparison scheme
Effect test

example 1

[0079]FIG. 7 illustrates a dual drug stent 700 having an anti-inflammatory agent and an antiproliferative agent delivered from different holes in the stent to provide independent release kinetics of the two drugs which are specifically programmed to match the biological processes of restenosis. According to this example, the dual drug stent includes an anti-inflammatory agent pimecrolimus in a first set of openings 710 in combination with the antiproliferative agent paclitaxel in a second set of openings 720. Each agent is provided in a matrix material within the holes of the stent in a specific inlay arrangement designed to achieve the release kinetics illustrated in FIG. 8. Each of the drugs are delivered primarily murally for treatment of restenosis.

[0080]As illustrated in FIG. 7, pimecrolimus is provided in the stent for directional delivery to the mural side of the stent by the use of a barrier 712 at the luminal side of the hole. The barrier 712 is formed by a biodegradable po...

example 2

[0085]According to this example, the dual drug stent includes the Gleevec in the first set of openings 710 in combination with the antiproliferative agent paclitaxel in the second set of openings 720. Each agent is provided in a matrix material within the holes of the stent in a specific inlay arrangement designed to achieve the release kinetics illustrated in FIG. 8.

[0086]The Gleevec is delivered with a two phase release including a high initial release in the first day and then a slow release for one to two weeks. The first phase of the Gleevec release delivers about fifty percent of the loaded drug in about the first twenty-four hours. The second phase of the release delivers the remaining fifty percent over about one-two weeks. The paclitaxel is loaded within the openings 720 in a manner which creates a release kinetics having a substantially linear release after the first approximately twenty-four hours, as illustrated in FIG. 8 and as described above in Example 1.

[0087]The amo...

example 3

[0088]According to this example, the dual drug stent includes the PKC-412 (a cell growth regulator) in the first set of openings in combination with the antiproliferative agent paclitaxel in the second set of openings. Each agent is provided in a matrix material within the holes of the stent in a specific inlay arrangement designed to achieve the release kinetics discussed below.

[0089]The PKC-412 is delivered at a substantially constant release rate after the first approximately twenty-four hours, with the release over a period of about four to sixteen weeks, preferably about six to twelve weeks. The paclitaxel is loaded within the openings in a manner which creates a release kinetic having a substantially linear release after the first approximately twenty-four hours, with the release over a period of about four to sixteen weeks, preferably about six to twelve weeks.

[0090]The amount of the drugs delivered varies depending on the size of the stent. For a three mm by six mm stent the...

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Abstract

An expandable medical device includes a plurality of elongated struts, forming a substantially cylindrical device which is expandable from a first diameter to a second diameter. A plurality of different beneficial agents may be loaded into different openings within the struts for delivery to the tissue. For treatment of conditions such as restenosis, different agents are loaded into different openings in the device to address different biological processes involved in restenosis and are delivered at different release kinetics matched to the biological process treated. The different agents may also be used to address different diseases from the same drug delivery device. In addition, anti-thrombotic agents may be affixed to at least a portion of the surfaces of the medical device for the prevention of sub-acute thrombosis. To ensure that the different agents remain affixed to the device as well as to each other, masking and de-masking processes may be utilized.

Description

BACKGROUND OF THE INVENTION[0001]1. Field of the Invention[0002]The present invention relates to tissue-supporting medical devices, and more particularly to expandable, non-removable devices that are implanted within a bodily lumen of a living animal or human to support the organ and maintain patency, and that have openings for delivery of a plurality of beneficial agents to the intervention site as well as a surface coating of an antithrombotic agent. The present invention also relates to a masking and de-masking process for promoting the adhesion of therapeutic agent / polymer matrices to the walls defining the openings in the medical device.[0003]2. Discussion of the Related Art[0004]In the past, permanent or biodegradable devices have been developed for implantation within a body passageway to maintain patency of the passageway. These devices are typically introduced percutaneously, and transported transluminally until positioned at a desired location. These devices are then expan...

Claims

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Application Information

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IPC IPC(8): A61F2/06
CPCA61F2/91A61F2250/0068A61L2300/00A61L31/16A61L33/0011A61L31/10
Inventor DAVE, VIPULFAIOTICO, ROBERTLI, CHENGXUENGUYEN, THAI M.PARKER, THEODORE L.ZHAO, JONATHON Z.
Owner CORDIS CORP
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