U.S. patent application number 13/731849 was filed with the patent office on 2013-05-16 for bone fixation pin.
This patent application is currently assigned to TOBY ORTHOPAEDICS, INC.. The applicant listed for this patent is Toby Orthopaedics, Inc.. Invention is credited to Eduardo Gonzalez-Hernandez.
Application Number | 20130123864 13/731849 |
Document ID | / |
Family ID | 43428066 |
Filed Date | 2013-05-16 |
United States Patent
Application |
20130123864 |
Kind Code |
A1 |
Gonzalez-Hernandez;
Eduardo |
May 16, 2013 |
BONE FIXATION PIN
Abstract
A bone fixation system and method are provided. The system
includes a dual prong pin and a bone screw. The pin is especially
configured and contoured to fixate fractures of the proximal
phalanx, especially hyperextension fractures. Fracture of other
long bones of the hand, foot or elsewhere may be managed with this
bone fixation system.
Inventors: |
Gonzalez-Hernandez; Eduardo;
(Coconut Grove, FL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Toby Orthopaedics, Inc.; |
Coral Gables |
FL |
US |
|
|
Assignee: |
TOBY ORTHOPAEDICS, INC.
Coral Gables
FL
|
Family ID: |
43428066 |
Appl. No.: |
13/731849 |
Filed: |
December 31, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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13439734 |
Apr 4, 2012 |
8343152 |
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13731849 |
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12537596 |
Aug 7, 2009 |
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13439734 |
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61086822 |
Aug 7, 2008 |
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Current U.S.
Class: |
606/329 |
Current CPC
Class: |
A61B 17/846 20130101;
A61B 17/8605 20130101; A61B 17/7233 20130101; A61B 17/7291
20130101; A61B 17/7208 20130101 |
Class at
Publication: |
606/329 |
International
Class: |
A61B 17/84 20060101
A61B017/84 |
Claims
1. A bone fixation pin for aiding reduction of a fractured bone and
for engagement to at least one bone screw, said bone fixation pin
comprising a first prong, a second prong, a central portion, and a
mid-longitudinal axis extending through said central portion and
between said first and second prongs, at least said first and
second prongs being adapted to support portions of the fractured
bone, said central portion including a first end, a second end, and
defining a first opening and a second opening, each of said first
and second openings defined by portions of two of a first arcuate
portion, a second arcuate portion, and a third arcuate portion,
said first opening adapted to receive a first bone screw of the at
least one bone screw and said second opening adapted to receive a
second bone screw of the at least one bone screw, said first and
second openings each having a center, said centers of said first
and second openings being provided on opposite sides of the
mid-longitudinal axis of said bone fixation pin, said first prong
extending outwardly from said first end of said central portion and
said second prong extending outwardly from said second end of said
central portion, said first and second prongs being symmetrical
about a first plane extending through the mid-longitudinal axis and
bisecting said central portion, said first and second prongs each
including at least one portion adapted contact the fractured
bone.
2. The bone fixation pin of claim 1, wherein said centers of said
first and second openings are offset from one another along a line
transverse to the mid-longitudinal axis of said bone fixation
pin.
3. The bone fixation pin of claim 1, wherein said first arcuate
portion extends around said center of said first opening more than
180 degrees.
4. The bone fixation pin of claim 3, wherein said third arcuate
portion extends around said center of said second opening more than
180 degrees.
5. The bone fixation pin of claim 4, wherein said second arcuate
portion is positioned between said first and third arcuate
portions.
6. The bone fixation pin of claim 1, wherein said first prong
extends in a second plane and said second prong extends in a third
plane, said second and third planes being substantially parallel to
one another.
7. The bone fixation pin of claim 6, wherein each of said at least
one portion of said first and second prongs include a first portion
and a second portion, said first portions and second portions
having angled relationships with one another.
8. The bone fixation pin of claim 7, wherein a fourth plane passes
through said first, second, and third arcuate portions, and said
first portions of first and second prongs each extend from said
central portion at angles substantially perpendicular to the fourth
plane.
9. The bone fixation pin of claim 1, wherein said first and second
arcuate portions define a first lobe of said central portion on one
side of the mid-longitudinal axis.
10. The bone fixation pin of claim 9, wherein said second and third
arcuate portions define a second lobe of said central portion on
the other side of the mid-longitudinal axis.
11. The bone fixation pin of claim 10, wherein said first and
second lobes are symmetrical about the mid-longitudinal axis.
Description
[0001] The present application is a continuation of U.S.
application Ser. No. 13/439,734, filed Apr. 4, 2012 (U.S. Pat. No.
8,343,152); which is a continuation of U.S. application Ser. No.
12/537,596, filed Aug. 7, 2009; which claims the benefit of U.S.
Provisional Application No. 61/086,822, filed on Aug. 7, 2008; all
of which are incorporated by reference herein.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] A bone fixation system and method suitable, for example, for
fracture fixation of the proximal phalanx of the hand or foot,
especially of the hyperextension type, are provided. The system is
also suitable for fixating fractures of other long bones of the
hand, such as the middle phalanx or the metacarpals, and of the
metatarsals in the foot. The system is also suitable for fixating
fractures in other bones outside of the hand or foot.
[0004] 2. Description of the Prior Art
[0005] Hyperextension fractures of the proximal phalanx are
typically problematic, especially in the elderly, because such
fractures are very difficult to stabilize. Current techniques and
devices can often lead to very significant functional impairment
and disability. These hyperextension fractures of the proximal
phalanx usually result in less optimal outcomes than fractures of
larger bones such as the distal radius.
[0006] One of the most common methods for fracture fixation is
pinning. In general, a pin has a sharp cutting tip. The pin is
driven into bone with the aide of a drill or an equivalent
mechanical device. Despite their versatility, pins have limitations
especially with fractures that have a significant amount of
fragmentation (comminution) of the bone at the fracture site or
when the fractured bone is too soft resulting in premature
loosening of the pins.
[0007] Another common method for fracture fixation of the small
bones of the hand utilizes plate fixation. However, use of plates
usually results in scaring which frequently limits the proper
gliding motion of the surrounding tendons, especially the extensor
tendon. A second surgery is usually necessary to remove the plate
and release the extensor tendon. This approach often results in a
large scar in the most visible part of the hand (not readily
received by most female patients). In the presence of significant
comminution and osteoporosis, as is often the case scenario in the
elderly female population with these fractures, plate fixation of
hyperextension fractures of the proximal phalanx is usually not
able to hold the alignment of the fracture because the plate has
limited mechanical ability to buttress these fractures and loss of
reduction is often frequent after plate fixation.
[0008] In addition, conventional plating of the long bones of the
hand frequently results in malalignment of the involved bone after
the plate is applied; the operated finger will tend to abnormally
scissor or overlap onto an adjacent finger. Thus, plating requires
absolute precision because even a small amount of angular
malalignment is not well tolerated.
[0009] Yet another fixation method utilizes a flexible nail/pin
mated to a locking sleeve. This method offers some advantages over
plating and pinning of the long bones of the hand. However, the
nail and sleeve configuration is not much different from pins and
has limited ability to control hyperextension fractures of the
proximal phalanx which frequently results in loss of fracture
reduction. In addition, a significant portion of the hardware is
prominent outside of the bone, irritating the tendons. Some relief
is provided by use of a protective plastic cap. In most cases, a
second surgery is needed to remove the nail and the prominent
locking sleeve.
SUMMARY OF THE INVENTION
[0010] In accordance with the principles embodying the invention, a
system and method for bone fixation are provided in the form of a
two prong buttress pin system. In its basic form, the system has
two components--a two prong or dual prong pin and one or more bone
screws, e.g., locking screws. The threads of the screw are designed
to mate with the dimensions of a locking domain of the two prong
pin.
[0011] The two prong pin is suitably contoured to work as a
buttress. Such contouring is especially suitable in fixating
hyperextension fractures of the proximal phalanx, but may also be
used for fixating other bones of the hand, foot or elsewhere. The
dual prong pin is also advantageous in addressing the most common
flexion deformity of metacarpal fractures. Because of the contoured
nature of the pin in accordance with principles embodying the
invention, four points of fixation are achieved, two in the
proximal fracture fragment and two in the distal fracture
fragment.
[0012] The two prong pin can be used by itself or with its one or
more bone screws. The bone screw, e.g., locking screw, is
constructed and configured to mate to the locking domain of the
pin. To facilitate insertion, a drill guide can be mated to the
locking domain of the two prong device to drill the precise
direction for the locking screw. A drill guide may be desirable but
is not necessary because the system is very accommodating.
[0013] In an illustrated embodiment, the two prong device has a
single locking domain to which a single bone screw may be mated. In
another embodiment, the dual prong pin may have two locking domains
to which two bones screw may be mated. More complex configurations
can be devised for accommodating more than one screw or to provide
an additional buttress in between the locking domains to provide
additional fixation and buttress support.
[0014] In another embodiment, the two prong pin has a retaining
feature configuration located on the distal portion of the prongs.
This retaining configuration can take the form of raised rings or
protrusions or barbs on the shank of the prongs. These
configuration variations help increase the gripping power of the
prongs, thus preventing separation of the fracture.
[0015] Specifically, a bone pin in accordance with the principles
embodying the invention includes a substantially U-shaped member
having a central region, a first prong extending from the central
region and a second prong extending from the central region, spaced
apart and opposite and parallel from the first prong. The central
region is configured to receive and mate with one or more bone
screws.
[0016] A bone fixation system in accordance with embodiments of the
invention includes a bone pin and one or more bone screws. The pin
is substantially U-shaped and has a central region, a first prong
extending from the central region and a second prong extending from
the central region, opposite and parallel to the first prong. The
central region is configured to receive and mate with the bone
screws. The central region lies in a transverse plane. The one or
more screws each have an elongate shaft, and when mated within the
central region, the shaft is substantially perpendicular to the
plane of the central region.
[0017] A method and kit for fixating bone fractures are also
provided. Other advantages and a better appreciation of the
specific adaptations, variations, and physical attributes of the
invention will be gained upon an examination of the following
detailed description of the invention, taken in conjunction with
the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] FIG. 1 illustrates a perspective view of a bone pin in
accordance with the invention having a dual prong configuration and
a single locking domain;
[0019] FIG. 2 illustrates a side plan view of a bone pin having a
single locking domain dual prong configuration;
[0020] FIG. 3 illustrates a top plan view of a bone pin having a
single locking domain dual prong configuration;
[0021] FIG. 4 illustrates a perspective view of a bone pin of FIG.
1 with a locking cortical screw engagingly mating the locking
domain;
[0022] FIG. 5 illustrates a perspective view of an embodiment of a
bone pin having dual lateral locking domains and a dual prong
configuration;
[0023] FIG. 6 illustrates a perspective view of an embodiment of a
bone pin of FIG. 5 with dual locking cortical screws engagingly
mating the locking domains;
[0024] FIG. 7 illustrates a perspective view of an embodiment of a
bone pin having a dual prong configuration with dual linear locking
domains;
[0025] FIG. 8 illustrates a perspective view of a bone pin of FIG.
7 with dual locking cortical screws engagingly mating the locking
domains with the mating feature of the screw;
[0026] FIGS. 9A and 9B illustrates front and rear perspective views
of a locking cortical screw, showing the self-cutting tip, the loop
mating groove, and the drive socket;
[0027] FIG. 10 illustrates a perspective view of a bone pin having
a single locking domain and dual prong configuration with varying
prong length;
[0028] FIG. 11 illustrates a perspective view of a bone pin having
dual prong configuration and single locking domain with a series of
barbs along the shank portion of the prongs;
[0029] FIG. 12 illustrates a perspective view of a bone pin having
a dual prong configuration and a single locking domain a series of
ringed protrusions along the shank portion of the prongs; and
[0030] FIGS. 13A, 13B, 13C and 13D illustrate the placement of a
bone pin system in accordance with the invention at a fracture
site.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0031] A bone fixation system embodying the principles of the
invention is provided. The system includes a fixed angle dual prong
bone pin and one or more bone screws, e.g., locking screws. The
system acts as a buttress to resist against the main deforming
forces acting on fractures, especially, for example, of the
proximal phalanx, such as those acting on hyperextension fractures.
The system is also well-suited for fixating fractures of other long
bones in the hand, such as the metacarpals and phalanges, and long
bones in the foot, such as metatarsals. Fractures of other bones of
the body may also be fixated with device and method described
herein.
[0032] Before any embodiments of the invention are explained in
detail, it is to be understood that the invention is not limited in
its application to the details of the structure and function set
forth in the following description or illustrated in the appended
drawings. The invention is capable of other embodiments and of
being practiced or of being carried out in various ways. Also, it
is to be understood that the phraseology and terminology used
herein is for the purpose of description and should not be regarded
as limiting. The use of "including," "comprising," or "having" and
variations thereof herein is meant to encompass the items listed
thereafter and equivalents thereof as well as additional items.
"Comprising" also encompasses the terms "consisting of" and
"consisting essentially of." The use of "consisting essentially of"
means, e.g., that a method may include additional steps, but only
if the additional steps do not materially alter the basic and novel
characteristics of the claimed method. Unless specified or limited
otherwise, the terms "mounted," "connected," "supported," and
"coupled" and variations thereof are used broadly and encompass
both direct and indirect mountings, connections, supports, and
couplings. Further, "connected" and "coupled" are not restricted to
physical or mechanical connections or couplings.
[0033] No admission is made that any reference, including any
patent or patent document, citied in this specification constitutes
prior art. In particular, it will be understood that unless
otherwise stated, reference to any document herein does not
constitute an admission that any of these documents forms part of
the common general knowledge in the art in the United States or in
any other country. Any discussion of the references states what the
author asserts and the applicant reserves the right to challenge
the accuracy and pertinence of any of the documents cited
herein.
[0034] As used in this specification and the appended claims, the
singular forms "a," "an," and "the" include plural referents unless
the content clearly dictates otherwise. As used in this
specification and the appended claims, the term "or" is generally
employed in its sense including "and/or" unless the content clearly
dictates otherwise.
[0035] Unless otherwise noted, technical terms are used according
to conventional usage. However, as used herein, the following
definitions may be useful in aiding the skilled practitioner in
understanding the invention. Such definitions shall be applied,
unless a different definition is given in the claims or elsewhere
in this specification.
[0036] As used herein, the term "substantially" in reference to a
shape or direction, for example, "substantially U-shaped," is meant
to refer to a general or overall shape or direction. For
"substantially U-shaped," it is understood, for example, that the
legs of the U may vary, e.g., the legs of a U may be equal in
length or unequal. The legs may also be curved or angled.
[0037] The terms "transverse plane" and "sagittal plane" are meant
to refer to the conventional planes used in describing a human
body, i.e., the sagittal plane travels along the Y-axis and the
transverse plane is in the horizontal plane perpendicular to the
sagittal plane.
[0038] The term "arcuate" is meant to describe a structure or a
portion of a structure as being curved or rounded. It is understood
that more than one arcuate portion may be present in a
structure.
[0039] In view of the foregoing disadvantages inherent in
conventional bone fixation systems, the invention provides a novel
system and method for fixating bone fractures, for example,
proximal phalanx fractures. Given that many fractures have not only
transverse fracture components but also oblique or even rather
frequently long fracture lines along the bone, it has been found
advantageous for pin placement with a dual shaft/prong pin in
accordance with principles of the invention.
[0040] In one aspect, the invention provides a bone pin with a
fixed angle dual prong or dual shaft configuration, and having
screw locking domains. Specifically, the pin is substantially
U-shaped, as seen in FIG. 3, having a central region, a first prong
extending from the central region and a second prong extending from
the central region, opposite and parallel to the first prong. The
prongs of the pin are pre-contoured, the exact shape of which
depends on the particular application. The central region lies in a
transverse plane which is perpendicular to the sagittal planes of
the contoured prongs.
[0041] The central region may have one or more screw locking
domains to receive and mate with a bone screw, e.g., a locking
screw. The locking domains of the pin are suitably one or more
arcuate portions, e.g., a loop or looped portion. In use, for
example, a locking bone screw is suitably mated in the locking
domain. The one or more screws each have an elongate shaft, and
when positioned and mated in the central region, i.e., the locking
domain, e.g., the loop, the shaft is generally perpendicular to the
(transverse) plane of the central region, i.e., the shaft lies in
the sagittal plane.
[0042] The direction of the screw placement in the looped portion
depends on the optimal configuration for individual fracture
fixation and is not limited as in the existing prior art devices.
In some embodiments, the bone pin according to principles of the
invention may have more than one screw locking domain. The domains
may be suitably positioned side by side, laterally or linearly. The
locking screw has bone threads that are designed to match and mate
with the features in the locking domain of the two pronged
pre-contoured pin.
[0043] The full mechanical advantage of the fixed angle dual prong
pin configuration in accordance with embodiments of the invention
is realized when the bone screw is mated to the arcuate locking
domain. For example, in embodiments in which the locking domain is
a loop, the head of the screw to be mated to the loop suitably has
a head to allow the diameter of the loop to mate with the minor
diameter of the threaded portion of the screw proximal end. Having
two fixed angle dual prongs oriented in identical directions into
the substance of the bone enhances the separation strength of the
pin from the bone far beyond that of a single shaft pin oriented in
a similar direction.
[0044] The bone pin in accordance with principles of the invention
is desirable in multiple fracture scenarios, and especially in
fractures of the bones of the hand or foot, for example, the
metacarpals and the phalanges. The bone fixation system is simple
to insert, has a very low profile, and minimizes tendon
irritation.
[0045] The dual prong configuration offers multiple mechanical
advantages over a single flexible nail. For example, the bone pin
according to principles of the invention has better rotational
control, lower profile, improved buttressing effect, and there is
no need for a secondary surgery. The system also has many
advantages over plating systems. For example, embodiments of the
bone pin improve buttressing of hyperextension fractures of the
proximal phalanx, a lower profile, and, unlike the plate, there is
no need for a secondary surgery to remove the device or to free the
scarred tendon resulting in no large scar. In addition, any
malrotation is easily corrected with the present two prong
device.
[0046] Reference is now made to FIGS. 1-4 in which a bone fixation
system, generally designated by reference numeral 10, in accordance
with embodiments of the invention is shown. System 10 includes a
dual prong pin 20 and a screw system 21 (e.g., as seen in FIG. 4)
for stabilizing bone segments. In an illustrated embodiment, dual
prong pin 20 is generally overall U-shaped (as shown in FIG. 3),
defined by a central region 23, a first prong 22 extending from
central region 23, and a second prong 24, extending from central
region 23, that is spaced apart and generally parallel to first
prong 22. Central region 23 includes one or more screw locking
domains 26 to receive and hold bone screws. Domains 26 are suitably
one or more arcuate portions, e.g., suitably, a loop 28, as shown,
e.g., in FIG. 1. Loop 28 has a predefined shape and size. Dual
prong pin 20 may be provided with any size of loop 28 as may be
suitable for a specific surgical application.
[0047] Dual prong pin 20 in accordance with the principles
embodying the invention may have many shapes. As shown in the
embodiment of FIG. 1, prongs 22, 24 are pre-contoured and suitably
have a generally arched shape 25 with, e.g., an arched section
aiding to grip the bone inner surface. In the embodiments
illustrated in FIGS. 1-4, generally arched shape 25 of prongs 22
and 24 includes, in the sagittal plane, a first bend or arcuate
portion 30 connected to a first linear portion 32 connected to a
second bend or arcuate portion 34. Bend 34 is connected to a second
linear portion 36 which is at an acute angle .alpha. to linear
portion 32. Linear portion 36 is connected to a third bend or
arcuate portion 38 connected to a third linear portion 40. Linear
portion 40 is at an oblique angle .beta. to linear portion 36.
Linear portion 40 is connected to a fourth bend or arcuate portion
42 and ending in a fourth linear portion 44 angled with respect to
linear portion 40 at an angle .gamma. and has a terminus 46. As
seen in FIG. 3, the overall configuration of pin 20 is U-shaped. As
described, the arched shape coupled with the fixed angle
combination enables a buttress pin configuration.
[0048] However, pin 20 can be configured in many different shapes
and sizes to accommodate any situation. For example, FIG. 1
illustrates a single loop dual prong configuration with prongs 22
and 24 of equal length and shape. FIG. 4 illustrates the embodiment
of FIG. 1 showing a locking cortical screw 21 engagingly mating the
locking domain. FIGS. 5 and 6 show perspective view of a lateral
dual loop configuration 64 with FIG. 6 illustrating screws 21
engagingly mating with the lateral loop 64. FIGS. 7 and 8 show
perspective view of a linear dual loop configuration 66, with FIG.
8 illustrating screws 21 engaging mating lateral loop 66. FIG. 10
further illustrates the prong configuration variation with two
varying prong lengths-one short and straight 30 and the other prong
with an arch 31.
[0049] In some embodiments, the prongs have a cylindrical shape,
i.e., a round cross-section. The pin profile is not limited to a
round cross-section and may also be constructed using any profile
e.g. square, hexagon, and triangle. In addition, the contour of the
prongs may also take any form pertaining to its particular
application. The inner surface of the cylindrical shape in the dual
linear loop area would be positioned against the bone surface.
[0050] Loop 28 is configured to receive above screw 21
therethrough. Screw 21 is used to anchor dual prong pin 20 to the
particular bone segments that require fixation. As shown in FIG. 9,
screw 21 has a head region 50 respectively at a proximal end 52.
Screw 21, which includes a threaded portion 54, extends from the
head region 50 to a distal end 56 of the screw. The locking
cortical screw engages the loop with the mating feature of the
screw.
[0051] To facilitate insertion, the threaded screws can be
self-tapping screws. The screw can also be self-drilling screw or
pre-drilled with the aide of a drill guide. Additionally, the
screws can be cannulated for insertion of a guide wire to guide
screw placement. The length of the individual screw shaft can be
selected for the particular application. FIG. 13 illustrates the
placement of pin 20 in accordance with the invention at a fracture
site.
[0052] That two prongs can be mated to the screw provides
additional fixation to bone because a screw, oriented into the
bone, will offer much more resistance to pull out than any existing
configuration. Torsional resistance is also theoretically greatly
increased.
[0053] Prongs 22, 24 may have a shank portion 60. In an embodiment,
prongs 22, 24 have barbs 62 disposed along shank 60, as shown in
FIG. 11. In another embodiment, as shown in FIG. 12, two prong pin
20 in accordance with embodiments of the invention has a retaining
feature configuration located on the distal portion of the prongs.
This retaining configuration can take the form of raised ring or
protrusions 64 on the underside of the prongs. These configuration
variations help increase the gripping power of the prongs thus
preventing separation of the fracture.
[0054] As described herein, the dual prong pin may be sized and
configured for particular application, thus allowing the pin to be
applied to the tibia, femur, humerus, forearm bone, and other bones
with which the invention may be used.
[0055] One of ordinary skill in the art will know and appreciate
that dual prong pin 20 may be provided with other types and
configurations of prongs in addition to the dual prongs as
illustrated. For example, dual prong pin 20 may be provided with
substantially varied configurations to its prongs and mounting,
with prongs consisting of varied shapes, configurations, and
mountings on a single device as shown in the drawings, or any other
type of configuration known to one of ordinary skill in the art,
e.g., one of the two prongs could be smooth with the other having a
barbed feature.
[0056] In practice, the two prong device is designed to "snap" in
place at the fracture site. In various embodiments, the second bend
of the prongs after the locking loop in the sagittal plane is
intended to secure the dorsal cortex of the bone at the fracture
site, thus providing a first point of fixation. The third bend of
the device in the sagittal plane works to provide the second point
of support for the device in the proximal fracture end. The third
and gentler bend in the sagittal plane works to provide the first
point of fixation to the distal fracture fragment across the
fracture site. A second point of support to the fragment across the
fracture site is provided by the two long prongs of the device.
Basically four points of fixation are achieved, two in the proximal
fracture fragment and two in the distal fracture fragment.
[0057] The invention also provides a method of fixating bone
fractures. The method includes positioning a dual prong pin having,
e.g., a loop, at the site of a fracture, and inserting bone screw
through the loop of the dual prong pin, thus locking the pin and
fragments to fixate the fracture. FIG. 13 illustrates the placement
of the bone fixation system at the site of the fracture.
[0058] The foregoing description is considered as illustrative only
of the principles of the invention. Further, since numerous
modifications and changes may readily occur to those skilled in the
art, it is not desired to limit the invention to the exact
construction and operation shown and described, and accordingly,
all suitable modifications and equivalents are considered to fall
within the scope of the invention. Various features and advantages
of the invention are set forth in the following claims.
[0059] All publications, patents and patent applications referenced
in this specification are indicative of the level of ordinary skill
in the art to which this invention pertains. All publications,
patents and patent applications are herein expressly incorporated
by reference to the same extent as if each individual publication
or patent application was specifically and individually indicated
by reference. In case of conflict between the present disclosure
and the incorporated patents, publications and references, the
present disclosure should control.
[0060] Other embodiments of the invention will be apparent to those
skilled in the art from consideration of the specification and
practice of the invention disclosed herein. It is intended that the
specification and examples be considered as exemplary only, with a
true scope and spirit of the invention being indicated by the
following claims.
* * * * *