Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Implantable prosthesis
Reexamination Certificate
1994-09-06
2001-01-09
Isabella, David (Department: 3308)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Implantable prosthesis
C623S001210
Reexamination Certificate
active
06171338
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to biodegradable surgical implants and/or devices.
BACKGROUND OF THE INVENTION
In surgery, it is known to employ at least partially biodegradable, elongated (typically tubular) surgical implants for supporting, connecting or separating elongated organs, tissues or parts thereof, such as canals, ducts, tubes, intestines, blood vessels, nerves, among others. In this context, a biodegradable, absorbable and/or resorbable, material refers to a material whose decomposition and/or dissolution products leave the system through metabolic ducts, kidneys, lungs, intestines and/or skin by secretion.
Examples of at least partially biodegradable implants include U.S. Pat. No. 3,108,357 to Liebig which suggests a tubular device to be implanted in animals and humans, comprising a resilient woven tube which contains biologically absorbable oxidized cellulose.
Additionally, U.S. Pat. No. 3,155,095 to Brown suggests hollow cylindrical anastomosis joints which are made of an absorbable material.
Further, U.S. Pat. No. 3,272,204 to Artandi and Bechtol suggests collagen-made flexible tubes which can be externally reinforced with a plastic coil or plastic rings.
Other examples of at least partially biodegradable implants include U.S. Pat. No. 3,463,158 to Schmitt and Polistina which suggests fiber-made tubular surgical devices which are at least partially made of absorbable polyglycolic acid (PGA).
U.S. Pat. No. 3,620,218 to Schmitt and Polistina also suggests PGA-made surgical devices, such as tubes.
Still further examples of at least partially biodegradable implants include WO 84/03034 to Barrows which suggests longitudinally openable, porous, coarse-surfaced biodegradable tubes used as a remedy for the nerves.
Additionally, the publication Plast. Rec. Surg. 74 (1984) 329, Dabiel and Olding, suggests an absorbable anastomosis device which comprises cylindrical, tubular, complementary parts.
However, known tubular, at least partially biodegradable surgical implants and devices involve several drawbacks and limitations. As for the implants including biostable parts, such as polymeric, and the like fibers, plastic or metallic coils or rings, or the like, such biostable parts or components remain in a patient's system even after a tissue or an organ has healed. Such components can later be harmful to a patient by causing infections, inflammatory reactions and like foreign matter reactions, and/or they might release particles, corrosion products, or the like which can wander in the system and/or cause harmful cellular level reactions.
Known tubular biodegradable implants manufactured by melt working technique or a like method are often massive and stiff and create, in resilient tissues, such as ducts, tubes, blood vessels, among others, an undesirable stiff, non-physiological bracing effect which can lead to harmful alterations in the properties of a tissue braced. In addition, the massive, tubular implants create a heavy local foreign matter loading the system at the installation site thereof and such loading can also contribute to harmful alterations in an operated tissue, such as canal, tube, duct, blood vessel, or the like.
On the other hand, the tubular structures constructed from biodegradable fibers by braiding, knitting, weaving or some other similar technique do not posses the structural rigidity and/or resilience often required of a support implant to be fitted inside or outside a tubular tissue.
SUMMARY OF THE INVENTION
It has been surprisingly discovered in the present invention that the deficiencies and drawbacks of known, at least partially biodegradable surgical implants and devices used for supporting, connecting or separating organs, tissues or parts thereof can be substantially eliminated with an implant, device or part thereof which is mainly characterized by comprising an at least partially biodegradable elongated member which is at least partially wound at least once around a center of rotation into a helical configuration and which is at least partially reinforced with biodegradable reinforcing elements.
An implant, device or part thereof (hereinbelow “device”) according to the present invention can be conceived, having been formed in a manner that around a certain center point is wound some elongated member at a distance of a certain winding radius from the center point. If the winding center is stationary and the winding radius increases as the winding angle increases, the configuration of an obtained device is a spiral configuration, especially if the winding radius remains in the same plane. Provided that the winding radius is constant and the winding center travels during the turning of an elongated member along a certain, for example, linear path, the device obtained has a circle-cylindrical screw-threaded configuration, or helix. On the other hand, if the winding radius changes while the winding center travels along a certain path, there will be produced a spiral configuration whose external surface is in conical shape. It is obvious that the implant, device or part thereof can include the above shapes and configurations as a combination and, for example, a combination of a spiral and a cylindrical screw-threaded configuration. The implant, device or part thereof can also be provided with members of other shapes in addition to a screw-threaded configuration, such as, for example, plates or sleeves.
The present invention relates also to a method for manufacturing an implant, device or part thereof (“device”) including at least partially winding at least once an elongated blank formed by a biodegradable polymer matrix and biodegradable reinforcement elements.
The invention relates also to the use of an implant, a device and part thereof.
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Williams, CRC Series in Biocompatibility, Biocompatibility of Clinical Implant Materials (vol. II), 1981, CRC Press, Inc., Boca Raton, Florida, pp. 60-66.
Pohjonen Timo
Rokkanen Pentti
Talja Martti
Törm{umlaut over (a)}l{umlaut over (a)} Pertti
Vainionp{umlaut over (aa)} Seppo
Biocon Oy
Isabella David
Kenyon & Kenyon
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