Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Arterial prosthesis – Having marker
Reexamination Certificate
1998-12-31
2001-03-13
Willse, David H. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Arterial prosthesis
Having marker
C623S023580, C428S036900
Reexamination Certificate
active
06200338
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to medical implants and more particularly to medical implants including medical tubing for catheters, stents, and other devices.
2. Background of the Invention
In certain medical procedures, medical implants are placed into the body. These implants include catheters inserted into body passages, vessels, or cavities for passing fluids, draining fluids, making examinations, etc. A stent is a second type of medical implant used to maintain a body orifice or cavity during skin grafting or to provide support for tubular structures, for example, during or after anastomosis.
It is generally desirable that medical implants, such as catheters and stents, be radiographically opaque such that their precise location within the host body can be detected by X-ray examination. In addition, it is advantageous that such medical implant be optically or visually transparent so that a flow of fluid therethrough may be observed.
Many tubular-shaped medical implants, such as catheters and stents are made from a polymer base. Suitable polymers are those that can be formed into tubular shapes that are, particularly in the case of catheters, flexible enough to be routed or snaked to a location in the body. In the case of a peripherally inserted central catheter (PICC), for example, the tubing of the catheter is routed or snaked, in one instance, through a vein in a patient's arm or neck to the superior vena cava of the patient's heart. The tubing should be flexible enough to be routed in this manner without causing trauma to the patient. The polymer chosen as the medical implant should also have sufficient strength when formed into a tubing so that the lumen does not collapse in a passageway or orifice. Still further, the tubing should be resistant to crimping or kinking so that a continuous passageway is assured. Polyurethane-based polymers are a popular choice for medical implant polymers, because certain polyurethanes possess the noted beneficial properties.
In general, polyurethanes are condensation products of reactions between diisocyanate (isocyanate compounds having a functionality of two) and soft-block polyols. Typically, polyurethanes are combined with low molecular weight aliphatic or aromatic diols or diamines as chain extenders to impart the useful properties of flexibility, strength, and kink resistance. Low molecular weight diols include butane diol, pentane diol, hexane diol, heptane diol, benzene dimethanol, hydraquinone diethanol and ethylene glycol. The addition of diamine chain extenders form a class of polyurethanes commonly referred to as polyurethaneureas. Suitable diamines include ethylene diamine, butanediamine, propane diamine and pentanediamine. An added feature of the polyurethanes with the diol or diamine chain extenders is that catheters or stents formed from these materials are typically optically or visually transparent making these polymer matrices excellent compounds for medical implants. Unfortunately, however, these polyurethanes are generally not radiopaque.
Radiopaque medical implants such as catheters, including radiopaque polyurethanes, have been developed. These radiopaque polymer structures are generally of two forms. A first form of radiopaque polymer incorporates a radiopaque filler or pigment. Typical filler materials include barium sulfate (BaSO4), bismuth subcarbonate, or certain metals such as tungsten (W). Other radiopaque fillers are pigments for incorporation into a polymer tube including bismuth oxychloride and other bismuth salts such as bismuth subnitrate and bismuthoxide (See U.S. Pat. No. 3,618,614). A drawback of the filler incorporated polymers is, although such polymers are radiopaque, the filler tends to make the polymer non-transparent.
A second form of radiopaque polymer useful in medical implants incorporates a halogenated-chain extender into the polymer matrix. Examples of these types of polymers are described in U.S. Pat. Nos. 4,722,344; 5,177,170; and 5,346,981. The preferred halogen in these patents is bromine (Br). Polymers incorporating a brominated-chain extender into the polymer matrix generally yield a tubing that is radiopaque and optically or visually transparent.
In order to impart useful radiopaque properties, the halogenated-chain extended polymer, such as a bromine-chain extended polymer, must have a minimum amount of halogen (e.g., bromine) to impart radiopacity to the polymer. Experimental studies show that the minimum amount of bromine, for example, in a polyurethane-based polymer useful as a catheter, is approximately 15 percent. Amounts less than this tend to make the tubing difficult to detect by X-ray.
A second problem with halogenated-chain extended polymers is the maximum amount of halogen that can be incorporated into the polymer is limited. Experimental studies have shown that polymers having, for example, a bromine concentration greater than 30 percent are too stiff for use as a medical implant, such as a catheter tubing. Accordingly, the radiopacity of the tubing is limited by the amount of bromine that may be incorporated in the polymer matrix without degrading the properties of the tubing made from such a polymer.
As noted above, certain halogenated-chain extended polymers offer both radiopacity and optical transparency. However, in order to maintain the superior properties demonstrated by conventional thermoplastic polyurethane elastomer with non-halogenated-chain extenders, the amounts of halogen must be strictly limited. It would be desirable, in certain instances, to have a halogenated-chain extended polymer with a radiopaque property that is not limited by the amount of bromine that is incorporated into the polymer matrix. What is needed is a combination that can maximize the radiopacity of the implant without increasing the halogen concentration of the polymer beyond that which would negatively effect the physical characteristics of the medical implant.
BRIEF SUMMARY OF THE INVENTION
A method and apparatus to provide enhanced radiopacity for a polymer while retaining its desirable flexibility or stiffness. In one embodiment, a medical implant such as a tubing is produced comprising a visually transparent radiopaque polymer and a radiopacifying filler material having a radiopaque component.
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Onwumere Fidelis C.
Solomon Donald D.
Blakey Sokoloff Taylor & Zafman
Ethicon Inc.
Koh Choon P.
Willse David H.
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