|Publication number||US3545008 A|
|Publication date||Dec 8, 1970|
|Filing date||May 27, 1968|
|Priority date||May 27, 1968|
|Publication number||US 3545008 A, US 3545008A, US-A-3545008, US3545008 A, US3545008A|
|Inventors||Karl F Bader Jr|
|Original Assignee||Karl F Bader Jr|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (2), Referenced by (59), Classifications (6)|
|External Links: USPTO, USPTO Assignment, Espacenet|
Dec. 8, 1970 UER; JR 3,545,008-
TENDON PRQSTHESIS Filed May 27, 1968 i .v awn roe.
iw/ F 491; /l:
United States Patent O 3,545,008 TENDON PROSTHESIS Karl F. Bader, In, Chicago, Ill. (2300 N. Rockton Ave., Rockford, Ill. 61101) Filed May 27, 1968, Ser. No. 732,404 Int. Cl. A61f 1/24 US. Cl. 3-1 6 Claims ABSTRACT OF THE DISCLOSURE A tendon prosthesis for use in tendon surgery particularly where there is complete or extensive loss of the tendon, structurally including an elongated member made from a flexible, chemically inert material having at least one flap at each end adapted to overlap the tendon and means for firmly anchoring the prosthesis to the tendon providing a strong, functional anastamotic union.
SUMMARY OF THE INVENTION 14 at each end adapted to overlap a repaired or reconstructed tendon 16. In addition a suture material 18 is incorporated within the elongated member 12 and each flap 14 has a mesh or netting 20 on its inner surface as shown in FIGS. 1 and 2.
As shown in the figures the tendon prothesis 10 is preferably an elongated member 12, however, it may be fabricated to any desired size and shape. The elongated member 12 is preferably fabricated from a sheeting material and may be reinforced as shown in FIG. 2 by a Dacron mesh 15 or similar material. The reinforcing increases the strength of the elongated member and prevents stretching during suture attachment. In addition, the elongated member 12 may be modified by the doctor sculpturing it to any desired size and shape at the time of surgery.
It is extremely important that the material used to form the elongated member 12 be substantially inert to prevent foreign body reactions. In addition the material must be compatible with the physiological processes of the human body and preferably has nonwetting surfaces which minimize sticking or encrustation. Further the material A further object is a full-function tendon prosthesis which is able' to withstand full Weight bearing capacity without separation or deformity.
Another object is a tendon prosthesis which is chemically inert and demonstrates a very low order of reactivity eliminating any incapacitating foreign body reactions.
Another object is a versatile tendon prosthesis which is adaptable to a variety ofclinical situations including instances of soft tissue avulsion, severe infection, electrical burn and surgical resection.
Another object is an improved tendon prosthesis which substantially eliminates adhesions and allows the patient to regain full range of motion including the ability for full active extension and flexion.
Another object is a tendon prosthesis which may be easily positioned and one positioned moves through the surrounding tissue with little resistance.
Another object is an improved method of constructing a strong and durable tendon prosthesis which necessitates no further surgical operations.
Other objects and advantages will be apparent from the ensuring specification and drawing for this invention.
BRIEF DESCRIPTION OF THE DRAWINGS DESCRIPTION OF THE PREFERRED EMBODIMENTS Referring to the drawing in more detail it will be seen that this invention basically includes an elongated member 12 made from a substantially inert material having flaps should contain the quality of nonadherence to tissue and is preferably resistant to adsorption, hardening and degeneration. A flexible silicone elastomer manufactured by Dow Corning sold under the trademark Silastic has been found to substantially meet the above mentioned qualifications. In addition other medical-grade silicone elastomers, or material similar to Silastic or equivalents thereof have been found as satisfactory material for the elongated member 12.
As best shown in FIGS. 1 and 2 a suture material 18 may be fabricated within the elongated member 12 by bonding two or more layers of sheeting material around the suture material. The ends of the prosthesis 10 are then spread apart to form a pair of flaps 14 for overlapping the repaired or reconstructed tendon. On the inside surface of each flap 14 there is secured a mesh or netting 20 formingsuitable end plates for tendon anastamosis. The flaps 14 with the mesh or netting 20 are devised to facilitate rapid and accurate areas of anastamosis with minimal exposure.
It is important that the mesh or netting 20 be made from a material or materials that cause fibroblastic infiltration to occur between the severed ends of the tendon 16 and the mesh 20 therebyfirmly anchoring the prothesis 10 With a strong, functional anastamotic union. One such material is polyester, however, similar materials or equivalents thereof have been found as a satisfactory mesh materal.
FIGS. 3 and 4 show how the suture attachment is performed in more detail. The flaps 14 overlap the tendon 16 with the mesh material resting against the outer surface of the tendon while the suture material 18 may be attached to each end of the tendon as shown in these figures. It should again be noted that the suture material 18 runs the full-length of the prosthesis 10 providing a strong durable means for attaching the prosthesis. The fibroblastic infiltration which occurs between the severed tendon 16 and the mesh 20 of each flap insures a strong, functional anastamotic union.
The use, operation and function of this invention are as follows:
The results from experiments and clinical use of this invention have been very favorable. The tendon prosthesis 10 allows the patient to regain essentially full range of motion within a short time after cast removal. In addition the prosthesis does not cause restrictive adhesions, infections or extrusions. Further, the tendon prosthesis can withstand full weight bearing capacity with no gross deformity including the ability for full active extension and flexion.
On reexploration of experimental uses of this inven tion each of the tendon prostheses were in good position and completely covered with a layered fibroblastic membrane. This delicate membrane was vascularized and substantially resembled normal synovial tissue. In fact the appearance of the entire tendon prosthesis is very similar to a normal tendon.
Functionally, the tendon prosthesis, and to a lesser degree its fibroblastic membrane, were found to move through the surrounding tissue with very little resistance. When the membrane was dissected, the respected tendon ends were noted to be firmly anchored to the prosthesis by the mesh material of the end flaps 14. In addition the membrane encasing, caused by the material of the elongated member, extended distally and around the normal tendon to reinforce the anastamosis.
It should be emphasized that the tendon prosthesis 10 was designed primarly as a full-function tendon after only one surgical procedure. Further surgical operations such as revision or replacement are not contemplated with this invention. However, it may be noted that if separation of an anastamosis did occur, it could be removed easily and the reactive membrane formed around the prosthesis could be utilized as a sheath for an autologous graft.
1. A tendon prosthesis for replacement of the damaged portion of a tendon as a full-function tendon including:
an elongated member made from a flexible substantially inert material that is compatible with the physiological processes of the human body;
a pair of flaps in opposed relationship at each end of the elongated member, said flaps being integral withv the elongated member and having an inside surface for enveloping the severed ends of the tendon and an outside surface designed for movement in the surrounding body tissue;
a mesh material secured to the inside surface of each flap adapted to contact only the severed ends of the tendon to form .a strong, functional anastamotic union, said mesh material being separated from the surrounding body tissue by the flaps; and
suture means running longitudinally the full-length of the prosthesis and extending beyond the end flaps for initially attaching the prosthesis to the tendon.
2. The structure of claim 1 further characterized in that the elongated member including the end flaps is made from a nonwetting, nonreactive material.
3. The structure of claim 1 further characterized in that the elongated member including the end flaps is made from a medical-grade silicone elastomer.
4. The structure of claim 1 further characterized in that the elongated member including the end flaps is reinforced with a mesh material to increase its strength.
5. The structure of claim 1 further characterized in that the mesh material is made from a polyester adapted to cause fibroblastic infiltration therethrough, thereby anchoring the prosthesis to the severed ends of the tendon.
6. In a tendon prosthesis for use in repairing a damaged tendon, the process of making the prothesis including the steps of:
bonding together a plurality of layers of medical-grade silicone elastomer sheeting over a suture material ex tending length-wise therein;
fabricating an elongated member from the medicalgrade silicone elastomer sheeting;
separating the distal ends of the prosthesis to a desired length to form end flaps having an inner surface and an outer surface, said inner surface being adapted to overlap the severed tendon;
placing a polyester mesh on the inner surface of each end flap for contacting only the severed ends of the tendon and thereby being separated from the surrounding body tissue by the end flap; and
bonding the polyester mesh to the inner surface of each end flap.
References Cited UNITED STATES PATENTS 3,176,316 4/1965 Bodell 3-1 3,197,788 8/1965 Segger 31 OTHER REFERENCES RICHARD A. GAUDET, Primary Examiner R. L. FRINKS, Assistant Examiner US. Cl. X.R.
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|U.S. Classification||623/13.15, 128/DIG.210|
|Cooperative Classification||A61F2/08, Y10S128/21|