Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form
Reexamination Certificate
1999-04-12
2002-01-22
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
C424S422000, C514S772300, C514S772400
Reexamination Certificate
active
06340465
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to simple-to-manufacture and simple-to-use coatings for use on a wide variety of substrates. In one embodiment, the coatings are especially useful in conjunction with medical devices, particularly devices that may come into contact with a subject's tissues or bodily fluids. The coatings of the present invention are thus useful in implantable or indwelling devices, as well as with devices that come into contact with a subject for a shorter period of time.
BACKGROUND OF THE INVENTION
During recent years, there has been a growing emphasis in the medical field on the use of a variety of materials, including synthetic materials, in devices and apparatus that may come into contact with the body and/or bodily fluids. Examples of synthetics used in medical devices and implants include polyethylene (PE), polytetrafluoroethylene (PTFE), silicone, silicone rubber, polyurethane, Dacron, gelatin-impregnated fluoropassivated Dacron (GIF), stainless steel, polyvinylchloride (PVC), nylon, latex, polystyrene, and fluorinated ethylene-propylene copolymer, to name a few.
Many applications have been developed for the use of synthetic materials in the manufacture of devices for use in all areas of medical treatment. Devices as structurally simple as artificial ocular lenses, as well as devices as complex as dialysis machines, can all be improved or enhanced by use of the within-described coating compositions.
While the use of synthetic materials in medical devices has certain attractive structural, chemical and manufacturing advantages, the use of such materials has created several problems which have plagued medical practitioners, however. For example, while synthetic materials tend to be mechanically stable and chemically inert, they are generally not biocompatible or lubricious, especially when directly exposed to bodily fluids, particularly blood. Moreover, undesirable physiological reactions such as thrombosis or bacterial infection may result because the synthetic surfaces attract proteins and other physiological fluid components which may cause the activation of humoral and cellular components of blood. The problem tends to become more acute as storage time (or implantation time) of the device is increased.
It is well known that the insertion or implantation of medical devices such as catheters and tubing into a patient often results in irritation of the area in immediate contact with the device. The surfaces of these devices are generally not lubricious and are not readily accommodated or tolerated when inserted past or through the mucous membranes or the vascular surfaces of a patient. Thus, surgical or prophylactic application of such a device may cause bleeding, discomfort, and subsequent infection. Moreover, the insertion of devices such as chest tubes or urinary catheters tends to cause an appreciable amount of discomfort to a patient as a result of the frictional resistance encountered during insertion of the device, as well as during any subsequent movement by the patient. Therefore, a coating that enhances the ease of insertion of a medical device, thereby decreasing the risk of injury to a patient, represents an important advancement in the art as well.
Although lubricants may be used to minimize initial friction, they are difficult to keep in place and may complicate handling of the devices. Further, there may be a risk of interaction between the lubricant and the patient. Lubricants that are applied immediately before use still require additional handling by medical personnel. Moreover, some lubricants may react with a previously heparinized surface decreasing the bioactivity of the heparin and reducing its ability to prevent the formation of clots. Similarly, prelubricated surfaces may render it difficult, if not impossible, to incorporate other biocompatible substances into—or coat such substances onto—medical devices and apparatus, as many substances may not adhere to a lubricant-coated surface. Further, the effectiveness of a pre-applied lubricant may diminish over an extended period of time during storage. Thus, a workable solution which does not require the use of additional compounds (e.g. pre-applied lubricants) is most desirable.
Accordingly, it is an object of the present invention to overcome the problems associated with the use of existing devices by providing novel lubricious coatings as well as new methods for producing medical devices, implants, and the like that enhance patient comfort. The present invention is also readily adapted to provide coatings that reduce the risk of infection and/or thrombosis.
The present invention also provides methods for producing coated medical devices, implants, and surfaces whose coatings include bound, yet bioreactive, molecules such as lubricity-enhancing agents, antimicrobial agents, anticoagulants, antibacterials, hormones, and the like. Methods for producing multi-functional surfaces in a simple, economical manner that can be utilized in conjunction with the assembly of single- and multi-component devices are also disclosed herein.
SUMMARY OF THE INVENTION
Coatings which have enhanced lubricious qualities—as well as methods of preparing, applying and using the coatings, and the devices to which the coatings have been applied—are disclosed herein. In addition, coatings which possess antimicrobial properties, antithrombotic properties, or both, are also disclosed, as are methods of preparing, applying and using such coatings.
The coatings of the present invention are sterilizable, stable, biocompatible and non-toxic, particularly during use. In addition, the coatings are durable and are able to maintain their lubricity and stability even after storage, sterilization, or both.
In a preferred aspect, this invention relates to coatings which include coupling agents and polyfunctional polymers which are able to form a crosslinked (or latticed) coating and are capable of entrapping hydrophilic and/or lubricious compounds. This capacity confers or enhances the lubricious quality of the coatings. In another aspect, this invention relates to lubricious coatings that include one or more biocompatible compounds that are capable of being coated upon or entrapped within the lattice of the coating.
In general, the present invention accomplishes these and other objectives by providing novel methods for producing devices which have stable, lubricious biocompatible surfaces. These surfaces may additionally contain other biologically active substances that make the surface even more multi-functional—for example, the coatings or surfaces of the present invention may include antimicrobial and/or anti-thrombogenic compositions.
Such surfaces are produced by coating medical devices—regardless of the composition of the device—with unique transitional coatings formed of compositions that are wettable. As a result, the biocompatible surfaces of the present invention are lubricious and may also be designed to be antimicrobial, protein-repelling and antithrombogenic at the earliest phases of the protein cascade effect.
Thus, in one embodiment, the invention discloses a stable, lubricious, biocompatible coating composition comprising a coupling agent, a polyfunctional polymer and at least one biocompatible agent, wherein the coupling agent and the polymer interact to form a three-dimensional crosslinking network which is capable of entrapping the biocompatible agent. The coatings of the present invention are particularly useful when applied to the surface of an apparatus or device, wherein the coupling agent component of the coating is capable of chemically linking the polyfunctional polymer to the surface of a device. In various preferred embodiments, the device or apparatus is a medical device.
The invention also discloses coating compositions wherein the polyfunctional polymer has two or more functionalities, as well as compositions in which the polyfunctional polymer has an equivalent weight of 100 or less. In variations of the invention, the polyfunctional polymer is selected from the group
Hsu Li-Chien
Hu Can B.
Chen Andrew
Condino Debra D.
Edwards Lifesciences Corp.
Fubara Blessing
James John Christopher
LandOfFree
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