Pipes and tubular conduits – Plural duct – Longitudinally extending common wall
Reexamination Certificate
1997-08-14
2001-06-05
Ruhl, Dennis (Department: 3761)
Pipes and tubular conduits
Plural duct
Longitudinally extending common wall
C138S128000, C602S042000, C277S946000
Reexamination Certificate
active
06240968
ABSTRACT:
FIELD OF THE INVENTION
The present invention generally relates to a membrane material useful in connection with a variety of medical applications, and more particularly to materials useful in making medical articles, such as, bandages, membrane barriers, pouches, tubing and/or device coverings or coatings.
BACKGROUND OF THE INVENTION
There exists a long-felt need for an improved construction material useful in making and/or forming medical articles or covers for such articles. Specifically, presently known materials are generally not thin enough, strong enough, soft enough or pliable enough to be useful in connection with a wide variety of applications. For example, known tissue replacement devices including porous polytetrafluoroethylene (PTFE) or natural mammal (e.g. bovine) materials, while soft, often require significant volume, thus causing more pressure on the damaged tissue than is necessary. Moreover, currently available materials useful in constructing bandages, covers, tissue replacement devices, etc. suffer from a variety of other drawbacks.
In addition, many currently known medical articles could be improved with enhanced performance characteristics through coating of the devices and/or articles with a medically-acceptable membrane material. In accordance with the present invention, the term “coating” refers to materials which are applied to the article by application, dipping or other methodologies.
In addition, devices formed from materials which exhibit sufficient pliability, strength and minimal thickness and dimensions, such as, tubing for or medical or other use, would be desirable.
In general, there exists a long-felt and unresolved need for a thinner, softer, more slippery, non-porous material for medical and other applications.
SUMMARY OF THE INVENTION
While the present invention, in accordance with its various aspects, has a multitude of applications, in general, a specially formulated membrane material is provided which, utilized alone or with other devices, provides an enhanced product. In general, such enhanced products are suitable for medical uses, however, other industrial or commercial applications for such products as are now known or hereafter devised by those skilled in the art are contemplated by the disclosure and claims set forth herein.
One aspect of the present invention is a membrane constructed from a modified polytetrafluoroethylene (“PTFE”) resin. The membrane is capable of being heat sealed to produce articles such as bags, sleeves, pouches, bandages and other articles having medical use.
In accordance with various other aspects of the present invention, the membrane may also be formed and shaped to suit a wide variety of medical applications. For example, the membrane can be heat sealed into structures such as pockets or sacks for cradling or isolating medical implant devices, organs or even other structures to contain bleeding. A variety of shapes and structures in various sizes can be fabricated from the membrane materials of the present invention.
In accordance with still other aspects of the invention, a preferred embodiment of the present membrane may function as a non-porous barrier between body fluids, tissues and/or organs. The non-porous property of the membrane may prevent bacteria from contacting and infecting tissue. Fluid and airborne bacterial contact may also be prevented by the membrane barrier.
Another beneficial property of a membrane in accordance with various aspects of the present invention is enhanced slip release. High slip release between the membrane and a contacting surface minimizes disturbance of healing tissues, thereby permitting faster recovery and reduced risk of infection. Stated another way, the membranes useful in the context of the present invention generally exhibit a non-stick property, such that they do not stick to weeping, healing wounds. Further, the membranes of the present invention may be used in sheet or fabricated form to cover and shield burns from ambient contaminants.
In accordance with various other aspects of the present invention, the membranes disclosed herein arc suitably non-porous and non-occluding, thereby tending to inhibit thrombotic/clotting conditions in a patient. The non-occluding feature is further enhanced and distanced from currently available PTFE extrusion tubing through tensilization, which the aforementioned inventors have discovered greatly enhances slip performance.
In accordance with further aspects of the present invention, a membrane film constructed from a modified polytetrafluoroethylene resin has two ends, which are sealed producing a generally tubular body. The membrane is preferably formed from a sintered, tensilized, modified polytetrafluoroethylene resin. The resin may comprise a homopolymer which is modified with less than five percent of pertluoro propyl vinyl ether (PPVE).
Tensilizing stretches and densifies the polymer film such that the tensilized film has enhanced slip properties which reduces the friction co-efficient. Tensilizing also enhances the suppleness and softness properties of the film, while simultaneously increasing the linear strength.
In accordance with still further aspects of the invention, the membrane materials suitably formed into tubular bodies can include sections which are tensilized; for example, some sections may be less tensilized or non-tensilized. The present invention encompasses thin-walled, large and small diameter tubing which covers a broader range of diameters and thicknesses than current paste extruded PTFE, FEP PFA (fluorocarbon) tubing. Moreover, such tubes may be formed with single or double heat seals in a wide range of seal widths.
In accordance with yet further aspects of the present invention, such tubular bodies can be combined with other devices, such as one or more tubes (e.g., PVC tubes) to form other useful devices. In such cases, the present invention relates further to the method and apparatus for loading such devices into such tubes.
In accordance with various other aspects of the present invention, multiple membranes may be combined to form multi-layer and/or multi-lumen structures. Such structures may be useful alone or after further manipulation in accordance with the various methods set forth herein.
In accordance with yet other aspects of the present invention, membrane tubes formed in accordance with the present invention may be manipulated and/or combined with one another to form useful devices. Such manipulations may include further singular or multiple sealing operations and/or use with other devices.
In accordance with still further aspects of the present invention, the membrane materials useful in the context of the present invention can be used as coverings and/or coatings for other devices, such as stents, tubes, etc. As a stent covering, in accordance with various aspects of the present invention, the membrane materials disclosed herein may be used singularly or in conjunction with other membrane materials covering all or a portion of the stent or other devices.
Alternatively, and in accordance with yet further embodiments of the present invention, the stents or other devices useable in connection with the membrane materials disclosed herein, such as tubes or other devices, may be variously coated with the membrane materials to provide still further useful medical articles.
As will be described in detail in the following detailed description of preferred embodiments of the present invention, the methods, apparatus and devices of the present invention thus facilitate creation of useful articles suitable for a variety of medical applications. Such devices may be used in connection with surgical and/or non-surgical procedures, for insertion into body orifices, canals, wounds and/or other anatomical openings natural or man-made, Such devices as will be appreciated by the skilled artisan offer significant advantages over presently known devices made from presently known materials.
REFERENCES:
patent: 4701291 (1987-10-01), Wissman
patent: 5088483 (1992-02-01), Heinecke
patent: 5194335 (19
Bigonzi-Jaker Anna Maria
Jaker Marc L.
Mager Carie
RTC, Inc.
Ruhl Dennis
Snell & Wilmer LLP
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