Surgery – Instruments – Orthopedic instrumentation
Reexamination Certificate
2001-07-26
2003-06-10
Truong, Kevin T. (Department: 3731)
Surgery
Instruments
Orthopedic instrumentation
C606S075000
Reexamination Certificate
active
06575974
ABSTRACT:
FIELD OF THE INVENTION
The present invention is a surgical device for setting fractured bones, such as connecting the fractured neck of a femur bone to its shaft with screws by means of a pre-drilled connector plate, without requiring a large incision to be made in the overlying skin and tissue. In particular, a new screwdriver is provided, together with a technique for its use, that improve the ease and reliability with which the screws are inserted and the fractured bone set.
BACKGROUND OF THE INVENTION
The present invention is an improvement of my U.S. Pat. Nos. 4,465,065 and 5,429,641. The subject matter of both patents is hereby incorporated by reference. Only those features of both patents are summarized below as are deemed helpful in explaining the structure, operation, need for and advantages of the present invention. A complete and thorough explanation of all the features of those patents can be gained, of course, from a direct reading thereof.
In U.S. Pat. No. 4,465,065 the connector plate has a sharp lower edge by which it penetrates through a small incision in the trochanter region into close contact with the shaft. During the operation the plate is temporarily attached to the horizontal portion of a connector arm, while the vertical portion of the connector arm extends parallel to the connector plate and is provided with holes which are coaxial with the holes in the plate. Concentric inner and outer guide tubes are inserted through the holes in the vertical portion of the connector arm, are pushed through the soft tissue up to the plate and serve as guides for pre-drilling of the bone parts in the correct position as viewed by X-ray equipment. After such pre-drilling, the inner guide tubes are removed and the outer tubes serve for guiding the insertion of long screws, and are afterwards removed. The long screws are tightened so as to compress the fracture. The plate is secured to the femur shaft with short screws, and the connector arm is then detached from the plate, and the wound is closed.
The device disclosed in U.S. Pat. No. 5,429,641 serves the same purpose as and has many features in common with the above-described device, but is designed to avoid certain of its drawbacks which came to light during its use in surgical operations (“operations” hereinafter) of the kind referred to.
In particular, U.S. Pat. No. 5,429,641 discloses a screw-and-sleeve assembly in which each long screw is axially movable within an associated sleeve that has a screw-threaded end that is firmly connected to a threaded bore in the connector plate. This feature permits active compression of the fracture by the surgeon and avoids a drawback of the above-described invention involving a gradual protrusion of the screw heads into the soft tissue causing subsequent irritation and pain to the patient.
Before going into its constructional details, it should be noted that the following directional expressions will be employed in respect of the femur bone, the connector plate, the screws and the related components of the surgical device. The expressions “top” and “upper portion” of any part will refer to the femur top, and the “bottom” or “lower portion” will refer to the direction towards the knee joint. The expression “inside” or “inner” will refer to parts close to the bone or pointing towards it, while the expression “outside” or “outer” will refer to those parts which are outside the human body being operated on, or pointing away from the bone.
The surgical device of U.S. Pat. No. 5,429,641 includes the following components.
Components Which are to Remain in the Body After the Operation is Completed:
1. A connector plate I.
2. Two long screws II used for connecting the fractured parts to the connector plate.
3. Two or more short screws 
33
 securing the lower plate portion to the femur shaft.
B. Auxiliary Equipment for Insertion and Fixation of the Permanent Components:
1. An angular connector arm IV.
2. Two long inner and outer guide tubes of a length sufficient to extend from the bores in the connector arm to the corresponding oblique bores in the connector plate. Outer guide tube 
31
 has an inner diameter corresponding to the diameter of the screw to be inserted and to be screwed into the fractured bone. Two inner, removable and alternately insertable guide tubes, are provided. Tube 
32
 is used first. It is concentrically bored to the diameter of a guide wire 
30
 to be pushed therethrough into the bone. After tube 
32
 has served its purpose and is removed, second tube 
32
a 
is used. It is concentrically bored to the diameter of a drill bit 
35
 adapted to pre-drill the femur bone for reception of the two screw-and-sleeve assemblies which include the long screws. The diameter of the pre-drilled bore in the femur accommodates the sleeve therein.
3. Two or more shorter guide tubes (not shown) for pre-drilling bone before final insertion of the short screws for firm attachment of the connector plate to the femur shaft.
4. A special screwdriver V adapted for manipulating the long screws and their sleeves to fix the sleeves to the connector plate, to insert the screws into the fractured bone, and to compress the fracture.
The auxiliary equipment is removed from the body after the connector plate has been firmly connected to the femur shaft with the short screws and long screws, and the fracture has been connected and duly compressed by means of the long screws, whereafter the wounds are to be dressed.
The connector plate I of substantially rectangular cross section illustrated in 
FIG. 1
 includes a straight lower, main portion 
1
 and a head portion 
2
 outwardly bent in respect of the main portion, to conform to the contour of the bone. Next to the head portion, two obliquely-directed, screw-threaded bores 
5
 penetrate the main portion at an angle of about 130°, the outer surface of the main portion being thickened by two lugs 
6
 permitting a greater length of the bores 
5
. The lower end 
8
 of the main portion is sharpened for the purpose of penetrating through the soft tissue and muscles close to the femur shaft during insertion of the connector plate through a small cut in the skin into its final position where it is attached to the bone with short screws.
An assembly of a long screw II and its relatively short sleeve III is illustrated in 
FIG. 2
, and details of both are shown in 
FIGS. 3 and 4
. The screw includes a relatively long shaft 
10
, an inner end 
10
a 
provided with screw thread 
11
 similar to that provided on wood screws, and an outer end 
10
b 
having a coaxial recess 
12
 formed therein in the shape of a hexagon that is axially extended with a screw-threaded bore 
13
 of a smaller diameter. The outer end 
10
b 
of the screw is slidably, but firmly, movable lengthwise and rotatably within the inner bore of sleeve body 
14
, which has its outer end 
14
b 
provided with outside screw thread 
15
 and slotted by two or four slots 
16
 serving to engage the screwdriver V. The inner end 
14
a 
of the sleeve III is inwardly crimped slightly, thereby preventing the screw II from sliding out of the sleeve by contact with a step 
17
 on the screw shaft.
FIGS. 5-10
 illustrate the auxiliary equipment serving for inserting and tightening long screws II and for compressing the fracture by bringing the bone parts toward each other after insertion of the screws is completed. The main component is an L-shaped connector arm IV which includes a horizontal portion 
20
 and a vertical portion 
21
 firmly connected to each other at right angles. The vertical portion 
21
 contains two large, obliquely-directed bores 
26
 which are coaxially aligned with the bores 
5
 in the connector plate, but are of a larger diameter for permitting the passage and fixation of the guide tubes.
FIG. 5
 illustrates an early stage of a surgical operation performed with the above-described device. After the connector plate I has been manually inserted by the surgeon into the thigh through a small cut and has been slid into an approximate position while being viewed by means of X-ray equipment, its cor
Nguyen Victor X
Truong Kevin T.
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