Prosthesis press and method of using the same

United States Patent [19]

Kimsev et al.

llllllJI'IIHIIillllllNIIHI [III II

US005176683A

Patent Number: 5,176,683 [45] Date of Patent: Jan. 5, 1993

[54] PROSTHESIS PRESS AND METHOD OF USING THE SAME

[76] Inventors: Timothy P. Kimsey, 14801 E. 44th St., Independence. Mo. 64055: William VV. Bohn, 6720 Willow La., Mission Hills, Kans. 66208

[21] Appl. No.: 688,683

[22] Filed: Apr. 22, 1991

[51] Int. CI.' A61F2/46

[52] U.S. CI 606/86; 606/99;

606/105; 128/677

[58] Field of Search 128/677, DIG. 20;

446/197, 198; 606/86. 90, 99, 105; 92/34

[56] References Cited

U.S. PATENT DOCUMENTS

2.823.668 2/1958 Van Court et al 128/DIG. 20 X

3.279.459 10/1966 Schenker 128/DIG. 20 X

3.319.532 5/1967 Pridham, Jr 92/34

4.102.339 7/1978 Weber et al 606/105

4.372,297 2/1983 Perlin 128/DIG. 20 X

4.378.009 3/1983 Rowley et al 128/DIG. 20 X

4.467.801 8/1984 Whiteside .

4.474.177 10/1984 Whiteside .

4.685.447 8/1987 Iversen et al 128/DIG. 20 X

4.772.287 9/1988 Rav et al 128/DIG. 20 X

4,898.161 2/1990 Grundei 606/90 X

4,907.574 3/1990 Hollerbach 128/DIG. 20 X

FOREIGN PATENT DOCUMENTS

1395352 5/1988 U.S.S.R 446/197

OTHER PUBLICATIONS

"Baumanometer @ quality" brochure by W. A. Baum
Co.. Inc. showing Baum Air-Flo ® Control.
"The P.C.A. Primary Total Knee System" from How-
medica. copyright 1984.

"The Miller/Galante Porous Tivanium Total Knee
Because No Two Knees Are Exactly Alike Sizing &
Instrumentation Charts" brochure, copyright 1984.
"Dow Corning Wright Whiteside Total Hip System"
brochure, copyright 1985 Dow Corning Wright.
"Whiteside Total Hip System Surgical Technique"
brochure, copyright 1985 Dow Corning Wright.
"Dow Corning Wright Brief Surgical Procedure for the

Whiteside Ortholoc II Total Condylar Knee System" brochure.

"Dow Corning Wright Whiteside Ortholoc II Posterior Stabilized Knee System" brochure, copyright 1987. "Dow Corning Wright Whiteside Ortholoc II Total Knee System Surgical Technique Total Condylar" brochure, copyright 1987.

"Dow Corning Wright Innovations in Total Knee Design Whiteside Ortholoc II Total Knee Systems" brochure.

"Dow Corning Wright Whiteside Ortholoc II Total

Condylar Knee System" brochure.

"Dow Corning Wright Whiteside Ortholoc II-C Total

Condylar Knee System": brochure.

"Dow Corning Wright Whiteside Ortholoc II Total

Knee System Surgical Techniques Posterior Stabilized"

brochure.

(List continued on next page.)

Primary Examiner—Robert A. Hafer

Assistant Examiner—Sam Rimell

Attorney, Agent, or Firm—Hovey, Williams, Timmons &

Collins

[57] ABSTRACT

A prosthesis press is provided which broadly includes an expandable force imparting member and an actuating member for expanding the force' imparting member between a joint and against at least one prosthetic member. The prosthesis press serves to hold the prosthetic member in place during curing of cement placed between the prosthetic member and the patient's bone, thereby freeing the surgeon to perform other tasks. The force imparting member preferably includes a bellows of resilient plastic material which is expandable upon receipt of fluid pressure therewithin and can at least partially conform to the exposed surfaces of various prosthetic members. The actuating member preferably includes a hand-operated air pump which is connected to the bellows by a conduit, and includes a relief valve for deflating and thus compressing the bellows to enable removal of the same.

3 Claims, 1 Drawing Sheet

OTHER PUBLICATIONS "Dow Corning Wright Brief Surgical Procedure for the Whiteside Ortholoc II Posterior Stabilized Knee System": copyright 1987.

"Insall/Burstein ® II Modular Knee System" folder containing: Insall/Burstein @ Posterior Stabilized II Modular Knee System Surgical Technique brochure,

copyright 1989 Zimmer, Inc.

"Zimmer® Intramedullary Knee Instrumentation for the Insall/Burstein ® Posterior Stabilized II Knee Surgical Technique" brochure, copyright 1989 Zimmer, Inc.

"Insall/Bursteein ® II Modular Knee System" brochure, copyright 1989 Zimmer, Inc.

PROSTHESIS PRESS AND METHOD OF USING
THE SAME

BACKGROUND OF THE INVENTION 5

1. Field of the Invention

This invention relates to a press used in retaining a prosthetic member in the bone of a patient during surgery, and more particularly to a device and method for exerting force against the prosthetic member, or a pair of prosthetic members, during curing of cement applied to one of the bone or prosthetic member. The press hereof employs an expandable member which enables the surgeon to conduct other tasks once the press is extended until the cement is sufficiently cured.

2. Description of the Prior Art

The use of prosthetic implants in the bone of a patient are well known in the field of orthopedic surgery. In many instances, the bone or cartilage of the patient has 20 been so damaged by injury or disease as to require that the natural joint be replaced by prosthetic implants. For example, in knee arthroplasty, the joint between the femur and the tibia may require that the proximal tibia and the distal femur are cut transversely and the por- 7<; tions of the removed bone are replaced by prosthetic members and the cartilage replaced with a tibia plastic insert. The components and procedures for this surgical technique are illustrated by a booklet, INSALL/BURSTEIN ® Posterior Stabilized II Modular Knee Sys- 30 tem Surgical Technique and further shown in U.S. Pat. Nos. 4.474,177 and 4.467,801, the contents of which are incorporated herein by reference.

Unfortunately, such surgical procedures are performed with an open incision in the leg or other body 35 member and can be very time consuming. One area which has proven particularly time-consuming is the need to cement the prosthetic members, such as for example, a tibial base or fixation plate and a femoral prosthesis or component, to the bone and allow the cement to sufficiently harden prior to concluding the procedure. The prosthetic members are conventionally of a stainless steel or titanium alloy, and the cement used to secure the prosthetic member to the bone typically requires about twenty minutes to dry or cure. Because the prosthetic member must maintain a good contact with the bone and cement and any voids therebetween reduce the strength of the reconstructed joint, the surgeon typically must manually exert a force of about forty to sixty pounds against the prosthetic member for the entire twenty minutes. In the case of knee replacement surgery, two such twenty minute periods are required—one for the femoral component and one for the tibial base.

As a result, joint replacement operations and knee arthroplasty in particular have been prolonged by the need for the surgeon to personally occupy him or herself with the simple task of holding the prosthetic member in place. During this period, the knee remains open and subject to infection, and the patient is anesthetized. In addition, the surgeon may become fatigued and the contact between the prosthetic member, bone and cement deteriorate if the force applied by the surgeon is substantially lessened. For all these reasons, a need has arisen for a simple, effective tool for limiting the time and effort necessary to ensure a positive contact between the prosthetic member, cement and bone during drying or curing of the cement.

SUMMARY OF THE INVENTION

This need has been largely met by the present invention which frees the surgeon from the mundane task of holding the prosthetic member in place during curing of the cement in surgery. The prosthesis press hereof not only enables the surgeon to perform other critical tasks while the cement cures, but in certain applications virtually halves the total amount of time spent in curing the bone cement with the prosthetic member in place. The prosthesis press includes an expandable member which is held in place by the prosthetic member or members to be cemented, and by expanding against the prosthetic member serves to exert the necessary force to maintain contact between the bone, cement and prosthetic member while the patient's muscles and ligaments provide the required opposing force when the joint is in an extended orientation.

The prosthesis press hereof broadly includes a force imparting member such as an expandable member which is preferably expandable responsive to internal fluid pressure, although other purely mechanical means could be employed. Means for expanding the force imparting member are provided and operably coupled to the force imparting member, including by way of example a fluid pressure generating device. While a variety of such pressure generating devices might be employed, one which is manually actuatable is preferable to provide the necessary control and "feel" for the surgeon. The pressure generating device is fluidically coupled to the expandable member preferably by a conduit, whereby the pressure may be generated from a remote location and applied at the joint by the expandable member.

In preferable forms, the prosthesis press includes a bellows which is made of resilient material and expands in response to air pressure introduced therein. The resilient material allows the bellows to contract when the source of pressure is removed. The pressure generating device is preferably provided with a manually actuatable relief valve to enable the surgeon to bleed off fluid, such as air, when the cement has sufficiently cured. The use of air as a fluid medium is preferable in that leakage poses less of a problem with air than water, and will continue to apply force to the prosthetic members for any extended period notwithstanding small leaks.

The bellows may be provided with a connector to the conduit which is complementarily configured to a recess in one of the prosthetic members. This configuration advantageously serves to locate the bellows in the space to be occupied by the plastic tibial insert. Lateral movement of the bellows during inflation and curing of the cement is avoided as the connector lodges in the recess and is held in position by the expanded bellows and the prosthetic member.

The apparatus hereof advantageously enables the surgeon to apply force to the prosthetic members in a novel procedure. When the surgeon has fully prepared the bone (when only one prosthetic member is to be inserted) or bones, cement is applied to one or both of the prosthetic member and the bone and the prosthetic members are then pressed into position with the joint in flexion. The prosthesis press is then inserted into the area normally occupied by the plastic insert and the joint is extended so that, for example, the femur and tibia are substantially aligned. The force applying member of the press is then expanded so that it exerts force against at least one of the prosthetic members, and pref