Title of Invention

INTERLOCKING INTRAMEDULLARY NAIL FOR UNION OF FRACTURE OF TIBIA

Abstract An interlocking intramedullary nail for tibial fractures defined by a hollow shaft having an axis and having a clover leaf cross section and a slit running throughout the length of the shaft, a platform at the operative proximal head end of the shaft; the shaft body having operative upper [proximal] and lower [distal] portions, an eye in the upper portion below the said platform, at least one interlocking hole defined in the said eye, a tapering end at the lower distal end with at least one interlocking hole; the upper end of the upper portion of the shaft being bent at and angle of 5 to 15 degrees with respect to the axis.
Full Text
FORM - 2
THE PATENTS ACT, 1970
(39 of 1970)

29/06/07

COMPLETE
Specification
(Section 10, rule 13)
INTERLOCKING INTRAMEDULLARY NAIL FOR UNION OF
FRACTURE OF TIBIA
DR. KANTILAL PANNALAL DAGA
of 131, Murarji Peth, Saraswati Chowk, Solapur 413 001, Maharashtra, India, an Indian National




Granted
THE FOLLOWING SPECIFICATION PARTICULARLY DESCRIBES THE NATURE OF THIS INVENTION AND THE MANNER IN WHICH IT IS TO BE PERFORMED:-

The invention relates to interlocking intramedullary nails used for union of fractures of tibia
The main purpose of this invention is to provide an interlocking intramedullary nail for union of fracture of tibia without use of any external plaster.
The conventional use of plaster for joining fracture of tibia since ages has the following disadvantages-
1) The average time taken of healing of fracture of tibia in plaster is 12-16
weeks which is longer and even more expensive than the proposed nail.
2)The patient can not work or walk freely without removal of plaster from
leg.
3)There is joint stiffness of knee and/or ankle in plaster as there are no
movements in plaster at all.
4) At times there are vascular complications in plaster which may lead to
muscle contracture in turn leading to deformities of foot or so.
Therefore the purpose and object of this invention is to avoid and overcome the above disadvantages by using an interlocking intramedullary nail which will reduce the time of union of fracture of tibia considerably. The anticipated union is more safe smooth, with use of this proposed nail, used intramedullary, which is optimum rigid, stable with less chances of malunion than in plaster (the percentage of unacceptable malunion with plaster is apprx.15%).


It takes less time for union of fracture of tibia as compared to plaster as no plaster is used after this operation & the patients are made to stand on the day of surgery only, (say 6 hrs after operation) without any plaster. So no more time is wasted in recovery of joint movements of knee and ankle, by physiotherapy which is needed after plaster removal and joint stiffness of these two joints is avoided.
Intramedullar nails for the tibia are known in the prior art. See for instance US Patent No.5,041,115 (no Indian equivalent application available) which has a circular cross section and no load bearing platform. A patient who is implanted with the prior art nail cannot walk erect without the help of crutches for a significant period.
This invention proposes an intramedullar nail for joining tibia fractures which enables a person having the nail implanted within him to be come mobile without the help of crutches within a few hours after the completion of the operation.
According to this invention there is provided an interlocking intramedullary nail for tibial fractures defined by a hollow shaft and an axis and having a clover leaf cross section and a slit running throughout the length of the shaft, a platform at the operative proximal head end of the shaft; the shaft body having operative upper [proximal] and lower [distal] portions, an eye in the upper portion below the said platform, at least one interlocking hole defined in the said eye, and a tapering end at the lower distal end with at least one interlocking hole; the upper end of the said upper portion being bent at an angle of 5 to 15 degrees with respect to the said axis.


The invention will now be described with reference to the accompanying
drawings, in which
Figure 1 is the side view of the intramedullar tibial nail in accordance with
this invention;
Figure 2 is the front view of the nail of figure 1;
Figure 3 is the rear of the nail of figure 1;
Figure 4 is the top plan view [proximal end view] of the nail of figure 1;
Figure 5 is the distal end view of the nail figure 1;
Figures 6 and 7 show the alternative of locations for the hole in the eye at
the proximal portion of the nail of figure 1;
Figure 8 shows the position of the hole in the distal portion of the nail of
figure 1; and
Figures 9a and 9b show the nail of figure 1 in its operative configuration.
Referring to the drawings, the nail in accordance with this invention consists of a shaft 3 having a slit 4, having a proximal portion A and a distal portion B. The shaft has posterior slit hollow body with a clover leaf cross section. The proximal portion includes a D shaped platform 1, extending from the shaft 3 and an eye 2 having a hole. The thick D shaped platform 1 at the top acts like a beam over two walls of the nail, which bears the blows of hammer during insertion and weight of body during early weight bearing. A part aa typically 6 to 7 cms of the proximal portion A is bent with respect to the rest of the shaft 3 at an angle of from 5 to 15 degrees in relation to the axis of the shaft 3. The D- shaped platform 1 at the end of the proximal portion is flat on one side & curved in the front) with overhanging edges. The eye 2 is in the anterior wall of the proximal portion A. The hole in the


eye 2 can be at preferred locations as seen in figures 6 and 7. The hole at times is in the center of eye or at lower portion of an eye. The breadth of the eye 2 is typically 3-4mm and length is 7-8mm and the hole in the eye 20 is provided for a cortical screw.
The distal portion B terminates in a tapering end for facilitation of insertion of nail in distal fragment of fracture without causing any problem, and at least one hole 5 is provided adjacent to the tip typically at a distance of 25mm from the lower tip. The cross section of nail is cloverleaf as seen in figure 5 and throughout its length a slit 4 of 3-4 mm is provided i.e. posteriorly for compressibility in transverse axis esp. in distal fragment of the fracture and eases the entry in distal fragment of fracture.
The distal interlocking hole 5 antero-posterior in the anterior wall of nail is provided for accommodation of cortical screw of 4.5 mm for inter locking purpose, for prevention of rotation of fragments of fracture of tibia. The hole in the eye 2 is provided for accommodation of upper interlocking screw for providing a static interlocking system.
The D-shaped platform 1 at the top of proximal end of nail has overhanging edges without any slit at the back, and is usually 100mm in diameter with flattened surface at the back and the rounded portion of D is at the front. This D shaped platform works as a beam over two walls of nail during weight bearing and bears the gentle blows of hammer during insertion.
Distal hole -5- provided in the distal portion of nail, for passing of interlocking screw for prevention of rotation. The body of the nail is


typically of stainless steel 316/316L which is biocompatible and the body
tolerates it well without any reaction to the body after insertion. The
diameter, length and weight depends upon the respective patient and his/her
configuration. Typical diameters used are 8mm, 9mm and 10mm and the
lengths used are 26cm, 27cm to 37cm, 38cm etc. (with one cm
difference)and the weight of nail variable in each and every patient


I Claim:
1) An interlocking intramedullary nail for tibial fractures defined by a hollow shaft having an axis and having a clover leaf cross section and a slit running throughout the length of the shaft, a platform at the operative proximal head end of the shaft; the shaft body having operative upper [proximal] and lower [distal] portions, an eye in the upper portion below the said platform, at least one interlocking hole defined in the said eye, a tapering end at the lower distal end with at least one interlocking hole; the upper end of the upper portion of the shaft being bent at and angle of 5 to 15 degrees with respect to the axis.
2) An interlocking intramedullary nail for tibial fractures as claimed in claim 1, in which the interlocking hole in the said eye is in the middle of the
eye.
3) An interlocking intramedullary nail for tibial fractures as claimed in claim
1, in which interlocking hole in the said eye is at the lower end of the eye.
4) An interlocking intramedullary nail for fracture of tibia substantially as
herein described and illustrated.
Dated this 5th day of December 2003.
MOHAN DEWAN
OF R.K.DEWAN & COMPANY
APPLICANT'S PATENT ATTORNEY


Documents:

1245-mum-2003-abstract.doc

1245-mum-2003-abstract.pdf

1245-mum-2003-cancelled pages(25-01-2005).pdf

1245-mum-2003-claims(granted)-(25-01-2005).doc

1245-mum-2003-claims(granted)-(25-01-2005).pdf

1245-mum-2003-claims.doc

1245-mum-2003-claims.pdf

1245-mum-2003-correspondence(07-02-2005).pdf

1245-mum-2003-correspondence(ipo)-(13-01-2005).pdf

1245-mum-2003-correspondence.pdf

1245-mum-2003-description(granted).doc

1245-mum-2003-description(granted).pdf

1245-mum-2003-drawing(25-01-2005).pdf

1245-mum-2003-drawing.pdf

1245-mum-2003-form 1(05-12-2003).pdf

1245-mum-2003-form 1.pdf

1245-mum-2003-form 19(08-12-2003).pdf

1245-mum-2003-form 19.pdf

1245-mum-2003-form 2(granted)-(25-01-2005).doc

1245-mum-2003-form 2(granted)-(25-01-2005).pdf

1245-mum-2003-form 2(granted).pdf

1245-mum-2003-form 2(title page).pdf

1245-mum-2003-form 26(05-12-2003).pdf

1245-mum-2003-form 26.pdf

1245-mum-2003-form 3(05-12-2003).pdf

1245-mum-2003-form 3.pdf

1245-mum-2003-form-2(granted).doc

1245-mum-2003-form-pct-isa-210.pdf

1245-mum-2003-u.s.patent.pdf

1245-mum-2003-wo international publication report a1.pdf

abstract1.jpg


Patent Number 205363
Indian Patent Application Number 1245/MUM/2003
PG Journal Number 30/2008
Publication Date 25-Jul-2008
Grant Date 29-Mar-2007
Date of Filing 05-Dec-2003
Name of Patentee KANTIAL PANNALAL DAGA
Applicant Address 131, MURARJI PETH, SARASWATI CHOWK, SOLAPUR,
Inventors:
# Inventor's Name Inventor's Address
1 KANTIAL PANNALAL DAGA 131, MURARJI PETH, SARASWATI CHOWK, SOLAPUR - 413 001,
PCT International Classification Number A 61 B
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA