US 3722003 A
An L-shaped lenticular prosthesis molded from FEP or medical grade silicone rubber to its final size, ready for inspection, packaging and sterilization, said prosthesis being entirely free of residual stresses.
Claims available in
Description (OCR text may contain errors)
ilnited States Patent 91 Walchle [451 Mar. 27, 1973 MOLDED L-SHAPED LENTICULAR PROSTHESIS  Inventor: David L. Wal chle, Cincinnati, Ohio [73 Assignee: Xomox Ohio 22' Filed: May 18, 1971  Appl. No.: 144,538
 US. Cl 3/1, l28/DIG. l4, l28/DIG. 21  Int. Cl ..A61f 1/2A,A6lf'1/18  Field of Search ..3/l; 128/350 R, DIG. Z1, 14,
 References Cited I UNITED STATES PATENTS 3,454,006 7/1969 Langdon ..128/214.4
FOREIGN PATENTS OR APPLICATIONS 4/1903 France ..128/349R OTHER PUBLICATIONS New Artificial Eardrums are Made from Soft Plastic" Science Illustraded, March I948, pp. 30-31.
Micro-Surgery Instruments 84 Implants Catalog, Richards Mfg. Co., I966, page (fonn 2866), Teflon Lindeman-Silverstein Arrow Drain Tube Relied Upon.
Silastic Artificial Eustachian Tube, by J. A. Donaldson, The Bulletin of the Dow Corning Center for Aid to Medical Research, Vol. 7, No. 1, Jan. 1965, page 2. Experiences with the Ossicular Chain, by B. W; Armstrong, Annals of Otology, Rhinology, and Laryngology, Vol. -78, N0. 5, Oct. 1969, pages 939-949.
Primary Examiner-Richard A. Gaudet Assistant Examiner-Ronald L. Frinks Attorney-J. Warren Kinney, Jr.
 ABSTRACT An L-shaped lenticular prosthesis molded from PE? or medical grade silicone rubber to its final size, ready for inspection, packaging and sterilization, saidprosthesis being entirely free of residualstresses.
4 Claims, 6 Drawing Figures PATENTEUHARZYISYS 3,722,003
INVENTOR DAVID L. WALCHLE er I FIG- 3 FIG- 4 78 4 M i MOLDED L-SHAPED LEN'IICULAR PROSTHESIS BACKGROUND OF THE INVENTION 1. Field of the Invention This invention relates to otology prosthesis and particularly to an L-type lenticular prosthesis which is fabricated by molding to exact dimensions and final size.
2. Description of the Prior Art The prior art insofar as it relates to L-type lenticular prostheses for lenticular and long process replacement utilized a hollow cylindrical tube of Teflon which was substantially severed to provide a pair of hollow, cylindrical portions of unequal length interconnected by a thin, unsevered, hinge forming web. The outer ends of the hollow cylindrical portions were then provided with a V-shaped cut which imparted a certain resilience to the cylindrical portions which enabled their outer ends to be fitted over the long process of the incus and the lenticular process of the stapes for replacing the lenticular and long process of an ear.
SUMMARY OF THE INVENTION An object of the present invention is to provide an L- shaped prosthesis which is fabricated as a single operation from molded FEP or medical grade silicone rubber. By molding the parts to their final size the difficulties and microscopically machining the parts is eliminated and the residual stresses ever present in the prior art devices is eliminated. Such residual stresses, in the case of an L-shaped prosthesis tend to straighten out the prostheses either before or after it is implanted in the ear.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a view partly in section of a human ear wherein the lenticular and long process have been replaced with an L-shaped prosthesis of the invention.
FIG. 2 is an enlarged perspective view of the prosthesis per se of FIG. 1.
FIG. 3 is a sectional view taken on line 33 of FIG. 2.
FIG. 4 is a sectional view taken on line 44 of FIG. 2.
FIG. 5 is an enlarged view illustrating a diseased condition of the lenticular and long process which are to be replaced by the prosthesis of FIG. 2.
FIG. 6 is a view similar to FIG. 5 illustrating the subject' prosthesis having been secured to the long processes of the incus and the lenticular processes of the stapes for replacing the diseased bones of FIG. 5.
DESCRIPTION OF THE PREFERRED EMBODIMENT With particular reference to FIGS. l-6, a human ear includes a tympanic membrane 40, a middle ear 44, and an external auditory canal 46. The numerals 70 and 72 denote a pair of substantially cylindrical, elongate tubular members which are interconnected as at 74, and wherein each of said members are provided with an elongate slit 76 and 78, respectively, which extend throughout the entire length of their respective cylindrical portions. Adjacent end surfaces 80 and 82 of members 70 and 72 are disposed at substantial right angles, and each of members 70 and 72 terminate in outer, axial end surfaces 84 and 86, respectively.
' that the elongate slits 76 and 78 enable the cylindrical It should be understood that the prostheses illustrated in FIGS. 1-6 are greatly enlarged for clarity of detail and understanding, since in actual practice they have the following dimensions: cylindrical members 70 and 72 have an CD. of 0.065 inch, an ID. of 0044-0045 inch, and slits 76 and 78 are the width of a razor cut. The overall length of 70 is three-sixteenths inch, the length of 72 is but three thirty-secondths inch, and the interconnection at 74 is about 0.010 inch. When molded from medical gradesilicone rubber excellent results have been obtained when the prosthesis has a durome ter factor of 60 to 70. The molded parts may be either air or thermal cured.
When used the otologist will carefully excise the diseased portion of the ossicular chain denoted generally by the letter D of FIG. 5 for providing and exposing a free outer end of the long process of the incus and the lenticular process of the stapes after which portion 70 of the prosthesis is slipped over and attached to the end of the long process of the incus and portion 72 is slipped over and attached to the lenticular process of the stapes, as in FIGS. 1 and 6, for thereby creating an efficient and effective replacement for the aforesaid diseasedportions of the ossicular chain. j
With particular reference to Flg. 6, it will be noted members 70 and 72 to firmly engage the lenticular and long process by reason of the inherent resilience of said tubular members which are adapted to be opened incident to their attachment, as illustrated.
The aforesaid L-shaped prosthesis is adaptedto be used by otologists such as, by way of example, is more fully described in the article by B. W. Armstrong, M- D., of Charlotte, NC, appearing in the Annals of Otology, Rhinology and Laryngology, Oct. 1969, Volume 78, No. 5, pages 939-949.
The prostheses of the present invention are all fabricated entirely from FEP or from medical grade silicone rubber and uniformly satisfactory results have been obtained wherein the prostheses have been molded to final size in a multicavity mold. The present ,use, upon removal from their individual package,
without requiring resterilization before use, by the otologist.
What is claimed is:
l. A one-piece, moulded, resilient L-shaped lenticular prosthesis for placement in the ossicular chain of a human ear to replace a damaged or diseased section of the ossicular chain which has been removed exposing a free outer end of the long process of the incus and the lenticular process of the stapes, comprising a pair of elongate, hollow tubes each having inner and outer ends, said tubes interconnected at a right angle to one another at an adjacent edge portion of their inner ends by an integral web at one side of the inner ends, one of said tubes being longer than the other of said tubes, and each tube slit longitudinally the entire length thereof on the side thereof opposite said web so that said tubes may be flexed open and their outer ends placed over the lenticular and long process and then allowed to close and firmly engage the lenticular and long process comprises PEP.
3. A prosthesis as in claim 1 in which the prosthesis comprises medicalgrade silicone rubber.
4. A prosthesis as in claim 3, wherein the silicone rubber has a durometer value offrom 60-70.