Prosthesis (i.e. – artificial body members) – parts thereof – or ai – Ear or nose prosthesis
Reexamination Certificate
2000-05-23
2002-09-24
Isabella, David J. (Department: 3738)
Prosthesis (i.e., artificial body members), parts thereof, or ai
Ear or nose prosthesis
Reexamination Certificate
active
06454803
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention is an implant utilized in nasal reconstructive surgeries. In the primary mode, the device is intended to provide support for the external nasal valve when natural cartilage is insufficient due to prior poorly-performed rhinoplasty, trauma, defects, or age. In this preferred mode, the device is an elongated, concave, oval-shaped member, preferably constructed of a porous polyethylene. A unique method of the implantation thereof is also provided, wherein the implant is placed through an external rhinoplasty approach. More particularly, residual lower lateral cartilage is removed, the implant is inserted into an external valve pocket formed by the same, staying in place due to soft tissue therearound, and the nasal tip is re-draped. In total, usage of the foregoing allows patients to experience significant improvement in breathing and airway management following the external nasal valve reconstruction procedure.
2. Description of the Prior Art
Many innovations for nasal implants and polyethylene devices are provided in the prior art, described as follows. Although these inventions are suitable for the purposes they address, they differ from the present invention as contrasted herein. Following is a summary of patents most relevant to the invention at hand, including description of differences between features of the invention and those of the prior art.
1. U.S. Pat. No. 4,938,234, Invented by Capriotti, Entitled “Method Of Surgically Implanting A Contour Nasal Implant”
In the patent to Capriotti, a method is disclosed for surgically implanting a contour nasal implant into a nose of a patient to elevate the nasal tip and to augment and to improve the frontal and profile views of the patient's nose. The method comprises the steps of drawing, onto the nose of a patient into which a contour nasal implant is to be surgically implanted, a line connecting the highest points of the superior palpebral sulci such that the line crosses the nasal dorsum at a point representing the nasion and the highest point of implant insertion; placing two pledgets in each nostril in the nose of the patient; performing an open rhinoplasty incision into the skin located between the nostrils of the patient; retracting superiorly the columella skin off of the lower lateral cartilages on each side of the nostril up to the highest point of the natural dome of the nose of the patient; dissecting the skin off of the dorsum of the nose to the line previously drawn across the nasal dorsum; inserting a contour nasal implant having an elongated central member having a dorsal section, a predetermined shaped tip and a keel having a selected width and length which is located under the predetermined shaped tip with the keel thereof extending downward between the lower lateral cartilage until the desired implantation position is obtained; and suturing the rhinoplasty incision in the skin between the nostrils.
2. U.S. Pat. No. 5,030,232, Invented by Pham, Entitled “Nasal Implant Device With Improved Contour”
The nasal implant of the Pham invention is characterized by a composition of hard-grade silicone fashioned into a special shape. One variation in the composition material is to use soft silicone only for the tip in order to overcome the fear of some surgeons to use hard silicone in this particular area. A special and improved shape of the implant, in the form of a modified hourglass, provides a well rounded and larger tip portion thanb that of the prior art. The supra-tip of this improved implant shows a depression dorsally, is less wide than the rest of the implant and has a pronounced slope laterally. These features, particularly at the supra-tip region avoid the unnatural effects of the prior art devices. Moreover this implant has a variable thickness form upper end to tip—that is it starts thin, increases in thickness and then goes thinner again—whereas the prior art starts thin and continually increases throughout.
3. U.S. Pat. No. 5,112,353, Invented by Johansson et al., Entitled “Contour Nasal Implant”
In the patent to Johansson et al., a contour nasal implant adapted to be used in rhinoplasty surgery is shown. The contour nasal implant includes an elongated, central member having a first end and a second end wherein the second end is spaced a predetermined distance from the first end. The first end of the elongated central member is flared to define a dorsal support end or dorsal section which is adapted to be positioned over the nasal dorsum in the nose of a patient to augment the frontal and profile views of the nose along the nasal dorsum. The second end includes a tip having a predetermined shape which is located on the same side of the elongated central member as the dorsal support end. A second end includes a keel having a selected width and length and the keel is located on the second end under the predetermined shaped tip. The keel is positioned substantially perpendicular to the elongated central member and is positioned such that the length of the keel is generally parallel to the elongated central member. The tip is operative, when implanted into the nose of a patient, to reshape and elevate the nasal tip of the nose of a patient. The tip and the dorsal support end contour and shape the frontal and profile views of the nose of a patient.
4. U.S. Pat. No. 4,994,084, Invented by Brennan, Entitled “Reconstructive Surgery Method And Implant”
The Brennan invention describes a homograft implant made from prepackaged, processed homograft material. The homograft material is taken in its purchased dehydrated form and cut into strips of varying shapes and sized. The strips are then adhesively secured together in a laminar manner by a tissue adhesive to form the desired shape and density of the implant. Once the implant has been made, it may then be surgically implanted in a desired location, immediately beneath the patient's dermis so as to alter the exterior appearance of the patient at the implant site. Since the implant is formed of dehydrated homograft material, endogenous tissue readily attaches to the implant after a short period of time, so that the implant becomes integral with the body.
5. U.S. Pat. No. 5,876,435, Invented by Swords et al., Entitled “Coupling for Porous Resin Orbital Implant and Ocular Prosthesis”
In the patent to Swords et al. an improved coupling method and device for an ocular prosthesis to a porous polyethylene implant is provided. According to the invention, a small surgical screws having a domed head is inserted into a porous plastic implant after the implant has been implanted into an enucleated orbit allowed to vascularize. The domed head projects from the anterior surface of the implant which is covered by conjunctive tissue and is received by a complementary cavity on the rear surface of the ocular prosthesis.
6. U.S. Pat. No. 5,053,050, Invented Itay, Entitled “Compositions for Repair of Cartilage and Bone”
In the patent to Itay, a defect is provided in cartilage or bone, or both, to excize damaged or pathological tissue, and it is filled with an implant having capability for complete regeneration of the skeletal tissue as a chondrogenic or osteogenic phenotype. The implant comprises cells expressing a chondrocyte phenotype (80×10
6
cells/ml) embedded in a biocompatible matrix having about 20% serum, which provides a permissive environment for maturation and transformation of the implant to a fully integrated state with the surrounding tissue. A portion of the implant may comprise a bone segment or a bone substitute.
7. U.S. Pat. No. 5,786,217 Invented by Tubo et al., Entitled “Methods and Compositions for the Repair of Articular Cartilage Defects in Mammals”
Provided in the patent to Tubo et al. are methods and compositions for the repair of articular cartilage defects in a mammal. Denuded chondrogenic cells are proliferated ex vivo as monolayer cultures in order to expand the pool of available chondrogenic cells. During proliferation the chondrogenic cells stop secreting the ext
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