FORM 2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENT RULES, 2003
COMPLETE SPECIFICATION
(See Section 10 and Rule 13)
A SURGICAL INSTRUMENT TO ALIGN AND LOCK A POLYINSERT WITH A TIBIAL COMPONENT
BIORAD MEDISYS PRIVATE LIMITED
AN INDIAN COMPANY REGISTERED UNDER THE COMPANIES ACT
WITH ADDRESS: SURVEY NO. 48, 3 & 48 7, PASHAN – SUS ROAD, SUS,
PUNE, MAHARASHTRA 411021
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE AND INVENTION THE MANNER IN WHICH IT IS TO BE PERFORMED.

FIELD OF THE INVENTION
[0001] The present invention relates to orthopedic surgical prosthetic devices used in knee replacement surgery. More particularly, the invention relates to instrumentation for proper alignment of a polyinsert of a prosthesis used in total knee replacement surgery.
BACKGROUND
[0002] Knee joint replacement surgery involves replacing a knee joint with an artificial knee joint, referred to sometimes herein as a “prosthesis” or “implant.” It often requires the surgical implantation of both femoral and tibial components. A typical knee prosthesis includes a patella prosthetic component, a tibial tray, a femoral component, and a tibial polyinsert positioned between the tibial tray and the femoral component. Femoral components are designed to be attached to a surgically-prepared distal end of a patient’s femur. Tibial trays are designed to be attached to a surgically-prepared proximal end of a patient’s tibia defining a recess that receives the tibial polyinsert. The tibial polyinsert provides a surface against which condyle surfaces of the femoral component articulate during use.
[0003] Forces applied to the tibial polyinsert by the femoral component during
articulation are complex, and adequate retention of the tibial polyinsert by the
tibial component must therefore be provided to avoid undesirable
displacement. It is often desirable to place a number of thicknesses of tibial
trial prostheses in sequence on the proximal tibia after a distal femoral
component has been positioned. This allows the surgeon to optimize fit. The
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surgeon tries each of the plurality of different tibial trial prostheses of different articular geometries and thicknesses. Once a tibial polyinsert that has a size and shape corresponding to the size and shape of the recess in which it is received is selected, next step is to ensure a secure fit between the two components.
[0004] Now a day, a surgeon uses several surgical instruments that involves a waste of time and lengthening of the duration of the operation which can involve a risk of infection of the knee. One such method known in the art is to push and seat the tibial polyinsert into the tibial base using a tibial plastic inserter instrument. This inserter is hammered or tapped distally to lock the tibial polyinsert into position. The surgeon then makes a carefully inspection of the anterior surface of the locking mechanism to ensure that the polyinsert has fully locked into place in the tibial base. Several shortcomings exist for the available method. This may cause indent on tibial polyinsert if not placed properly as well as may cause difficulty in locking polyinsert if not oriented properly.
SUMMARY
[0005] This summary is provided to introduce concepts related to a surgical instrument to align and lock a polyinsert with a tibial component. This summary is neither intended to identify essential features of the present invention nor intended to determine or limit the scope of the present invention.

[0006] The present invention discloses a surgical instrument to align and lock a polyinsert with a tibial component. The surgical instrument to align and lock a polyinsert with a tibial component comprises a body. The body comprises a hollow frame, a handle bar, a pusher, a fixed lever, a locking lever and a locking tongue. The hollow frame comprises a locking tab at a posterior end. The handle bar is disposed at a proximal end of the hollow frame. The handle bar is configured for screw adjustment. The handle bar comprises a cylinder, a compression spring and a screw. The cylinder is a hollow square structure. The cylinder is coupled at a proximal surface of the hollow frame. The cylinder comprises threads on inner surface. The compression spring is disposed on the cylinder. The screw is inserted inside the cylinder. The pusher is a square cylindrical structure. The pusher is disposed on cylinder. A proximal surface of the pusher is in a contact with the handle. The pusher is configured to push a polyinsert by moving linearly on the hollow square structure. The fixed lever and locking lever are coupled at the posterior side of the hollow frame. The locking tongue is disposed inside the body. One end of the locking tongue is coupled to the locking lever. The locking tongue is configured to slide linearly with the help of locking lever. The recess is disposed on an anterior surface of the tibial component.
[0007] During operation, in the first stage, the locking tab is inserted in
between polyinsert and tibial tray base through the recess. In the second stage,
locking lever is pressed in upward direction to push the locking tongue
towards tibial tray base. The locking tongue and the locking tab constrain the
anterior and posterior motion of the tibial component respectively. In the third
stage, the handle is rotated. The rotation of the handle is configured to provide
linear motion of pusher. In the fourth stage, the pusher rest on the polyinsert.
The pusher is configured to constrain movement of the polyinsert. The pusher
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is configured to hold and lock the polyinsert on tibial tray base.It will be appreciated that features of the present disclosure are susceptible to being combined in various combinations without departing from the scope of the present disclosure as defined by the below mentioned detailed description and drawings.
BRIEF DESCRIPTION OF ACCOMPANYING DRAWINGS
[0008] The summary above, as well as the following detailed description of illustrative embodiment, is better understood when read in conjunction with the appended drawings. For the purpose of illustrating the present disclosure, example constructions of the disclosure are shown in the drawings. However, the present disclosure is not limited to specific methods and instrumentalities disclosed herein. Moreover, those in the art will understand that the drawings are not to scale. Wherever possible, like elements have been indicated by identical numbers.
[0009] Embodiment of the present disclosure will now be described, by way of example only, with reference to the following diagrams wherein:
[0010] Fig 1. illustrates a perspective view of a surgical instrument in accordance with an exemplary embodiment of the present disclosure.
[0011] Fig 2. illustrates an exploded view in accordance with an exemplary embodiment of the present disclosure;

[0012] Fig. 3(a) and 3(b) illustrates a surgical instrument in attached and detached state with the tibial component with an exemplary embodiment of the present disclosure;
[0013] In the above accompanying drawings, a number relates to an item identified by a line linking the number to the item. When a number is accompanied by an associated arrow, the number is used to identify a general item at which the arrow is pointing.
[0014] Further the figures depict various embodiment of the present subject matter for purposes of illustration only. One skilled in the art will readily recognize from the following discussion that alternative embodiment of the structures and methods illustrated herein may be employed without departing from the principles of the present subject matter described herein.
DETAILED DESCRIPTION OF EMBODIMENTS
[0015] The following detailed description illustrates embodiment of the
present disclosure and manners by which they can be implemented. The
words "comprising," "having," "containing," and "including," and other forms
thereof, are intended to be equivalent in meaning and be open ended in that
an item or items following any one of these words is not meant to be an
exhaustive listing of such item or items, or meant to be limited to only the
listed item or items. It must also be noted that as used herein and in the
appended claims, the singular forms "a," "an," and "the" include plural
references unless the context clearly dictates otherwise. As used herein, a
“plurality” refers to two or more, for example, three or more, four or more,
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five or more, six or more. Each possibility represents a separate embodiment of the invention.
[0016] For purposes of the present specification and claims, as used herein, the term “anterior” may refer the front plane of the human body, e.g., a patient. Parts of prostheses labeled as “anterior” or “extending anteriorly” means that after implantation, those parts face or extend towards the anterior of the patient. As used herein, the term “posterior” may refer the back plane of the human body, e.g., a patient. Parts of prostheses labeled as “posterior” or “extending posteriorly” means that after implantation, those parts face or extend towards the posterior of the patient. It is to be understood that, by altering the orientation of the invention, certain relational terms may need to be adjusted accordingly.
[0017] The present disclosure provides technical solutions to the technical problems identified in the prior art. In the prior art, a surgeon uses several surgical instruments that involves a waste of time and lengthening of the duration of the operation which can involve a risk of infection of the knee. One such method known in the art is to push and seat the tibial polyinsert into the tibial base using a tibial plastic inserter instrument. This inserter is hammered or tapped distally to lock the tibial polyinsert into position. The surgeon then makes a carefully inspection of the anterior surface of the locking mechanism to ensure that the polyinsert has fully locked into place in the tibial base. Several shortcomings exist for the available method. This may cause indent on tibial polyinsert if not placed properly as well as may cause difficulty in locking polyinsert if not oriented properly.

[0018] The prior art is thus characterized by several disadvantages that are addressed by the present disclosure. The present disclosure is therefore directed towards minimizing, and in some aspects eliminating the above-mentioned failures, and other problems, by utilizing the methods and structural features described herein.
[0019] Embodiment of the present disclosure present technological improvements as solutions to one or more of the above-mentioned technical problems recognized by the inventor(s) in conventional systems.
[0020] The present invention discloses a surgical instrument to align and lock a polyinsert with a tibial component. The surgical instrument to align and lock a polyinsert with a tibial component comprises a body. The body comprises a hollow frame, a handle bar, a pusher, a fixed lever, a locking lever and a locking tongue. The hollow frame comprises a locking tab at a posterior end. The locking tab comprises a hook at the end. The handle bar is disposed at a proximal end of the hollow frame. The handle bar is configured for screw adjustment. The handle bar comprises a cylinder, a compression spring and a screw. The cylinder is a hollow square structure. The cylinder is coupled at a proximal surface of the hollow frame. The cylinder comprises threads on inner surface. The compression spring is disposed on the square structure. The screw is inserted inside the square structure. The pusher is a square cylindrical structure. The pusher is disposed on the square structure. A proximal surface of the pusher is in a contact with the handle. The rotation of handle in clockwise direction is configured to provide downward motion to ployinsert pusher, wherein during operation spring get compressed. Rotating the screw in anti-clockwise direction is configured to provide upward motion of the
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pusher, wherein during operation the compressed spring is configured to push the pusher in upward direction The pusher is configured to push a polyinsert by moving linearly on the hollow square structure. The fixed lever and locking lever are coupled at the posterior side of the hollow frame. The locking lever is configured to rotate in vertical direction around the pivot point. The one end of the locking lever is coupled with the locking tongue. The rotational motion of the locking lever is get converted into translatory motion of the locking tongue with the help of a sliding mechanism. The locking tongue is disposed inside the body. One end of the locking tongue is coupled to the locking lever. The locking tongue is configured to slide linearly with the help of locking lever. The hook along with locking tongue is configured to constrain a horizontal and a vertical movement of the tibial tray base. The locking tongue comprises curved surface at the one end to increases contact area with the tibial tray base. The curved surface is configured to provide grip during operation. The tibial component comprises a recess. The recess is disposed on an anterior surface of the tibial component. The recess is configured to provide opening to insert locking tab inside the gap between polyinsert and tibial tray base.
[0021] During operation, in the first stage, the locking tab is inserted in
between polyinsert and tibial tray base through the recess. In the second stage,
locking lever is pressed in upward direction to push the locking tongue
towards tibial tray base. The locking tongue and the locking tab constrain the
anterior and posterior motion of the tibial component respectively. In the third
stage, handle is rotated. The rotation of the handle is configured to provide
linear motion of pusher. In the fourth stage, the pusher rest on the polyinsert.
The pusher is configured to constrain movement of the polyinsert. The pusher
is configured to hold and lock the polyinsert on tibial tray base.
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[0022] The present invention discloses a surgical instrument to accurately position components of prosthetic joints without overly complicating the procedures.
[0023] The present invention discloses a surgical instrument which eliminates multiple impact on polyinsert eventually avoiding any damage to polyinsert and bone.
[0024] The present invention discloses a surgical instrument which does not present the disadvantages of the former art and which in particular is easy to handle eventually saving time of surgeon.
[0025] The invention discloses a simple surgical instrument that allows the surgeon to insert polyinsert with conjunction of the tibial base locking mechanism and eliminates orientation problem of polyinsert on the tibial base plate.
[0026] Additional aspects, advantages, features and objects of the present disclosure would be made apparent from the drawings and the detailed description of the illustrative embodiment.
[0027] It should be noted that the above advantages and other advantages will be better evident in the subsequent description. Further, in the subsequent section, the present subject is better explained with reference to the figures. In order to maintain consistency and brevity of reading, the all the figures from 1, 2, 3a and 3b are explained jointly. Further, the following table lists of
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nomenclature and numberings are used in the figure to illustrate the invention and the nomenclature is further used to describe in the invention the subsequent paragraph.
Nomenclature Number Nomenclature Number
surgical 100 cylinder 202
instrument
body 102 screw 206
handle bar 104 handle 208
pusher 106 pivot point 210
compression 108 curved surface 212
spring
fixed lever 110 hook 214
locking lever 112 tibial component 302
locking tab 114 polyinsert 304
locking 116 tibial tray base 306
tongue
hollow frame 118 recess 308
[0028] The person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure. It should be understood that this invention is not limited to the particular methodology, protocols, and the like, described herein and as such may vary. The terminology used herein is for the purpose of describing particular embodiment only and is not intended to limit the scope of the present invention, which is defined solely by the claims.
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[0029] Referring now to the drawings, Figures. 1-3 illustrates a surgical instrument having a mechanism to align a polyinsert perfectly on a tibial tray base in a more efficient and quick manner aaccording to present invention. It should be noted that Figure 1-3 are merely examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiments of the present disclosure.
[0030] Referring now to the drawings, Fig. 1 discloses a surgical instrument 100 to align and lock a polyinsert with a tibial component. The surgical instrument 100 to align and lock a polyinsert with a tibial component comprises a body 102. The body comprises a hollow frame 118, a handle bar 104, a pusher 106, a fixed lever 110, a locking lever 112 and a locking tongue 116. The hollow frame 118 comprises a locking tab 114 at a posterior end. The handle bar 104 is disposed at a proximal end of the hollow frame 118. The handle bar 104 is configured for screw adjustment. The fixed lever 110 and locking lever 112 are coupled at the posterior side of the hollow frame 118. The one end of the locking lever 112 is coupled with the locking tongue 116. The rotational motion of the locking lever 112 is get converted into translatory motion of the locking tongue 116 with the help of a sliding mechanism. The locking tongue 116 is disposed inside the body 118. One end of the locking tongue 116 is coupled to the locking lever 112. The locking tongue 116 is configured to slide linearly with the help of locking lever 112.
[0031] Fig. 2 discloses an exploded view of the polyinsert instrument. Fig. 2 discloses a surgical instrument 100 to align and lock a polyinsert with a tibial component. The hollow frame 118 comprises a locking tab 114 at a posterior end. The locking tab 114 comprises a hook 214 at the end. The handle bar 104
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is disposed at a proximal end of the hollow frame 118. The handle bar 104 is configured for screw adjustment. The handle bar 104 comprises a cylinder 202, a compression spring 108 and a screw 206. The cylinder 202 is a hollow square structure. The cylinder 202 is coupled at a proximal surface of the hollow frame 118. The cylinder 202 comprises threads on inner surface. The compression spring 108 is disposed on the cylinder 202. The screw 206 is inserted inside the square structure 202. The pusher 106 is a square cylindrical structure. The pusher 106 is disposed on the hollow square structure 202. A proximal surface of the pusher 106 is in a contact with the handle 208. The polyinsert pusher 106 is configured to push a polyinsert by moving linearly on the square structure 202. The rotation of handle 208 in clockwise direction is configured to provide downward motion to ployinsert pusher 106, wherein during operation spring 108 get compressed. The rotating the screw mechanism in anti-clockwise direction configured to provide upward motion of the pusher 106, wherein during operation the compressed spring is configured to push the pusher 106 in upward direction. The fixed lever 110 and locking lever 112 are coupled at the posterior side of the hollow frame 118. The locking lever 112 is configured to rotate in vertical direction around the pivot point 210. The one end of the locking lever 112 is coupled with the locking tongue 116. The rotational motion of the locking lever 112 is get converted into translatory motion of the locking tongue 116 with the help of a sliding mechanism. The locking tongue 116 is disposed inside the body 118. One end of the locking tongue 116 is coupled to the locking lever 112. The locking tongue 116 is configured to slide linearly with the help of locking lever 112.

[0032] Fig. 3(a) and 3(b), discloses the polyinsert instrument 100 with a tibial component 302 in the detached and attached state respectively. A tibial component 302 includes an articulating surface/polyinsert 304 and a tibial tray base 306. The articulating surface/polyinsert 304 of the tibial component 302 may be configured for receiving a head of a femoral component or the head of a natural femur (not shown). In operation, the locking tongue 116 of the polyinsert instrument 100 secures the polyinsert 304 on the tibial tray base 306 when the surgeon inserts the locking tab 114 into the recess 308 of the polyinsert 304 by pressing the pair of levers 110 and 112. As the surgeon rotates the screw 104, the polypusher 106 presses the polyinsert 304 eventually securing it on the tibial tray base 306. Once the polyinsert 304 is secured, the locking tab 114 can be removed from the recess of the polyinsert 304 by pressing the pair of levers 110 and 112. The hook 214 along with locking tongue 212 is configured to constrain a horizontal and a vertical movement of the tibial tray base 306. The locking tongue 116 comprises curved surface 212 at the one end to increases contact area with the tibial tray base 306. The curved surface 212 is configured to provide grip during operation 306. The tibial component comprises a recess 308. The recess is disposed on an anterior surface of the tibial component. The recess 308 is configured to provide opening to insert locking tab 114 inside the gap between polyinsert 304 and tibial tray base 306.
[0033] During operation, in the first stage, the locking tab (114) is inserted in
between polyinsert (304) and tibial tray base (306) through the recess (308). In
the second stage, locking lever (112) is pressed in upward direction to push
the locking tongue (116) towards tibial tray base (306). The locking tongue
(116) and the locking tab (114) constrain the anterior and posterior motion of
the tibial component (302) respectively. In the third stage, handle (208) is
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rotated. The rotation of the handle is configured to provide linear motion of pusher (106). In the fourth stage, the pusher (106) rest on the polyinsert (304). The pusher (106) is configured to constrain movement of the polyinsert (304). The pusher is configured to hold and lock the polyinsert (304) on tibial tray base.
[0034] Fig. 3(a) and 3(b) are mere examples. A person skilled in the art will recognize many variations, alternatives, and modifications of the embodiment of the present disclosure.
[0035] It is observed that the polyinsert is mounted on the tibia plate in an exactly matching position with the help of polyinsert instrument. It is further observed that along with the orientation of the polyinsert on the tibial tray base, the surgical instrument has provided the much needed advantage of elimination of multiple impact on polyinsert which eventually avoids any damage to polyinsert and bone.
[0036] The present invention has both technical as well as economic significance with respect to the conventional instruments use to align polyinsert on the tibial tray base.
[0037] While a particular embodiment of the invention has been illustrated and
described, modifications thereof will readily occur to those skilled in the art. It
is understood that the various embodiment, details and constructions of the
polyinsert instrument and its features described above and illustrated in the
attached figures may be interchanged among the various embodiment while
remaining within the scope of the invention. Additionally, it is understood
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that various modifications could be made to any of the polyinsert instrument and/or elements described herein above while remaining within the scope of the invention.

We claim-1. A surgical instrument (100) to align and lock a polyinsert (304) with a tibial component (302) comprises:
a body (102), wherein the body comprises:
a hollow frame (118), wherein the hollow frame (118) comprises a locking tab (114) at a posterior end;
a handle bar (104), wherein the handle bar (104) is disposed at a proximal end of the hollow frame (118), wherein the handle bar (104) is configured for screw adjustment, wherein the handle bar (104) comprises:
a cylinder (202), wherein the cylinder (202) is a hollow square structure, wherein the cylinder (202) is coupled at a proximal surface of the hollow frame (118), wherein the cylinder (202) comprises threads on an inner surface; a compression spring (108), wherein the compression spring (108) is disposed on the cylinder (202); a screw (206), wherein the screw (206) is inserted inside the cylinder (202); a pusher (106), wherein the pusher (106) is a square cylindrical structure, wherein the pusher (106) is disposed on the cylinder (202), wherein a proximal surface of the pusher (106) is in a contact with the handle (208), wherein the pusher (106) is configured to push a polyinsert by moving linearly on the hollow square structure (202);
a fixed lever (110) and a locking lever (112), wherein the fixed lever (110) and the locking lever (112) are coupled at the posterior side of the hollow frame (118);
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a locking tongue (116), wherein the locking tongue (116) is
disposed inside the body (118), wherein one end of the locking
tongue (116) is coupled to the locking lever (112), wherein the
locking tongue (116) is configured to slide linearly with the help
of locking lever (112);
a recess (308), wherein the recess is disposed on an anterior surface of
the tibial component (302); and
wherein during operation, in the first stage, the locking tab (114) is inserted
in between polyinsert (304) and the tibial tray base (306) through the recess
(308), wherein in the second stage, locking lever (112) is pressed in upward
direction to push the locking tongue (116) towards tibial tray base (306),
wherein locking tongue (116) and locking tab (114) constrain the anterior
and posterior motion of the tibial component (302) respectively, wherein
in the third stage the handle (208) is rotated, wherein the rotation of the
handle is configured to provide linear motion of the pusher (106), wherein
in the fourth stage, the pusher (106) rests on the polyinsert (304), wherein
the pusher (106) is configured to constrain movement of the polyinsert
(304), wherein the pusher is configured to hold and lock the polyinsert
(304) on the tibial tray base (306).
2. The surgical instrument (100) to align and lock the poly insert (304) as claimed in claim 1, wherein the locking lever (112) is configured to rotate in a vertical direction around a pivot point (210), wherein the one end of the locking lever (112) is coupled with the locking tongue (116), wherein the rotational motion of the locking lever (112) is get converted into a translatory motion of the locking tongue (116) with the help of a sliding mechanism.

3. The surgical instrument (100) to align and lock the polyinsert (304) as claimed in claim 1, wherein the recess (308) is configured to provide opening to insert locking tab (114) inside the gap between polyinsert (304) and tibial tray base (306).
4. The surgical instrument to align and lock the polyinsert as claimed in claim 1, wherein rotating the handle (208) in clockwise direction is configured to provide downward motion to the pusher (106), wherein during operation spring (108) get compressed.
5. The surgical instrument to align and lock the polyinsert as claimed in claim 1, wherein rotating the screw in an anti-clockwise direction isconfigured to provide an upward motion of the pusher (106), wherein during operation the compressed spring is configured to push the pusher (106) in upward direction.
6. The surgical instrument to align and lock the polyinsert as claimed in claim 1, wherein the locking tab (114) comprises a hook (214) at the end, wherein the hook (214) along with the locking tongue (212) is configured to constrain a horizontal and a vertical movement of the tibial tray base (306).
7. The surgical instrument to align and lock the polyinsert as claimed in claim 1, wherein the locking tongue (116) comprises a curved surface (212) at the one end to increases contact area with the tibial tray base (306), wherein the curved surface (212) is configured to provide grip during operation.

Dated this on,
22nd day of February, 2024
For, BIORAD MEDISYS PRIVATE LIMITED

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