U.S. patent application number 17/328844 was filed with the patent office on 2021-09-09 for device for driving fixation elements into bone and method of use thereof.
This patent application is currently assigned to A.M. SURGICAL, INC.. The applicant listed for this patent is A.M. SURGICAL, INC.. Invention is credited to Ather Mirza, Romi Mirza.
Application Number | 20210275240 17/328844 |
Document ID | / |
Family ID | 1000005600897 |
Filed Date | 2021-09-09 |
United States Patent
Application |
20210275240 |
Kind Code |
A1 |
Mirza; Ather ; et
al. |
September 9, 2021 |
DEVICE FOR DRIVING FIXATION ELEMENTS INTO BONE AND METHOD OF USE
THEREOF
Abstract
A implanting device for driving a fastener or fixation element
into bone is described. Also described are methods for using a
implanting device for driving a fastener or fixation element into
bone and a kit comprising a pneumatic implanting device for driving
a fastener or fixation element into bone.
Inventors: |
Mirza; Ather; (Saint James,
NY) ; Mirza; Romi; (Henderson, NV) |
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Applicant: |
Name |
City |
State |
Country |
Type |
A.M. SURGICAL, INC. |
Smithtown |
NY |
US |
|
|
Assignee: |
A.M. SURGICAL, INC.
|
Family ID: |
1000005600897 |
Appl. No.: |
17/328844 |
Filed: |
May 24, 2021 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16518540 |
Jul 22, 2019 |
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17328844 |
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15837910 |
Dec 11, 2017 |
10420598 |
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16518540 |
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14644838 |
Mar 11, 2015 |
9867647 |
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15837910 |
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62051094 |
Sep 16, 2014 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/921 20130101;
A61B 2017/924 20130101; A61B 2017/00544 20130101; A61B 17/0401
20130101; A61B 2017/00548 20130101; A61B 17/72 20130101; A61B
2017/564 20130101; A61B 17/92 20130101; A61B 17/848 20130101; A61B
2017/0409 20130101 |
International
Class: |
A61B 17/92 20060101
A61B017/92; A61B 17/04 20060101 A61B017/04; A61B 17/72 20060101
A61B017/72; A61B 17/84 20060101 A61B017/84 |
Claims
1-28. (canceled)
29. An implanting device for driving a fastener or fixation element
into bone, comprising: a chamber for holding a fastener or fixation
element, a barrel having a proximal end and a distal end, wherein
the proximal end is connected to the chamber for propelling the
fastener or fixation element from the chamber, a propulsion source
functionally connected to the chamber, wherein the propulsion
source comprises a compressed or loaded spring, and a triggering
mechanism for releasing the spring from compression or loading,
wherein the released spring propels the fastener or fixation
element from the chamber through the barrel and driving the
fastener or fixation element into bone contacted with the distal
end.
30. The implanting device of claim 29, wherein the fastener or
fixation element is selected from the group consisting of a
Kirschner wire, an intramedullary nail or a suture anchor.
31. The implanting device of claim 29, further comprising a
replaceable cartridge containing one or more fasteners or fixation
elements.
32. The implanting device of claim 29, wherein the trigger
mechanism comprises a safety that prevents releasing the spring
when the distal end of the barrel is not in contact with bone.
33. The implanting device of claim 32, wherein the safety prevents
actuation of the trigger mechanism when the distal end of the
barrel is not in contact with bone.
34. A method for the fixation of a fractured long bone with an
intramedullary nail, comprising: providing an access point to the
medullary canal of the long bone, reducing the bone fragments at
the fracture, contacting the distal end of the barrel of the
implanting device of claim 29 with the access point, aligning the
barrel of the implanting device with the medullary canal at the
access point, and actuating the trigger mechanism of the implanting
device to deliver an intramedullary nail into the medullary canal,
thereby fixing the bone fragments in the reduced state.
35. The method of claim 34, wherein the access point is a hole in
the bone.
36. The method of claim 35, wherein the hole is created with a
drill.
37. The method of claim 35, wherein the hole is created with an
awl.
38. The method of claim 34, wherein the long bone is selected from
the group consisting of metatarsal bones and metacarpal bones.
39. The method of claim 38, wherein the metatarsal bones and
metacarpal bones include the phalanges.
40. A method for the fixation a fractured bone using at least one
Kirschner wire, comprising: reducing at least one bone fragment
with at least one adjacent fragment or the main body of the bone;
contacting the distal end of the barrel of the implanting device of
claim 29 with the at least one bone fragment, the at least one
adjacent fragment or the main body of the bone; aligning the
implanting device with the at least one bone fragment and the at
least one adjacent fragment or the main body of the bone; and
actuating the trigger mechanism of the implanting device to deliver
a Kirschner wire affixing the at least one bone fragment to the at
least one adjacent fragment or the main body of the bone, thereby
fixing the at least one bone fragment in the reduced state.
41. The method of claim 40, wherein the bone is the humerus.
42. The method of claim 41, wherein the at least one bone fragment
is from the proximal end of the humerus.
43. The method of claim 40, wherein the bone is the femur.
44. The method of claim 43, wherein the at least one bone fragment
is from the head of the femur.
45. The method of claim 40, wherein the bone is a carpal bone or a
tarsal bone.
46. A kit comprising the implantation device of claim 29 and a
fastener or fixation element.
47. The kit of claim 46, wherein the fastener or fixation element
is selected from the group consisting of a Kirschner wire, an
intramedullary nail and a suture anchor.
48. The kit of claim 46, further comprising a replaceable cartridge
containing one or more fasteners or fixation elements.
Description
[0001] This application is a continuation application of U.S.
patent application Ser. No. 15/837,910, filed Dec. 11, 2017, which
is a continuation application of U.S. patent application Ser. No.
14/644,838, filed Mar. 11, 2015, now U.S. Pat. No. 9,867,647, which
claims the priority of U.S. Provisional Application Ser. No.
62/051,094, filed Sep. 16, 2014. The entirety of the aforementioned
application is incorporated herein by reference.
FIELD
[0002] This application generally relates to medical devices. In
particular, the application relates to a device for implanting
fixtures into bone.
BACKGROUND
[0003] Complex and simple fractures of bones have been found to
heal more quickly and efficiently when the fragments are held
together with fixation elements such as Kirschner wires (k-wires)
or intramedullary nails (IM nails). However, at times it can be
difficult to insert fixation elements into the bone quickly enough
or with sufficient force in order to make effective contact between
the bone fragments in a reduced fracture.
[0004] The present application provides a device for effectively
and rapidly driving fasteners and fixation elements into bone
tissue using pneumatic pressure.
SUMMARY
[0005] One aspect of the present application relates to an
implanting device for driving a fastener or fixation element into
bone, comprising: a chamber for holding at least one fastener or
fixation element, a barrel having a proximal end and a distal end,
wherein said proximal end is connected to said chamber for
propelling said fastener or fixation element from said chamber, a
propulsion source functionally connected to said chamber, and a
triggering mechanism for releasing propellant from said propulsion
source into said chamber and charging said chamber in order to
propel said fastener or fixation element from said chamber through
said barrel and driving said fastener or fixation element into bone
contacted with said distal end.
[0006] Another aspect of the present application relates to a
pneumatic implanting device for driving a fastener or fixation
element into bone, comprising: a chamber for holding at least one
fastener or fixation element, a barrel having a proximal end and a
distal end, wherein said proximal end is connected to said chamber
for propelling said fastener or fixation element from said chamber,
a gas source functionally connected to said chamber, and a
triggering mechanism for releasing propellant gas from said gas
source into said chamber and charging said chamber in order to
propel said fastener or fixation element from said chamber through
said barrel and driving said fastener or fixation element into bone
contacted with said distal end.
[0007] Another aspect of the present application relates to a
method for the fixation of a fractured long bone with an
intramedullary nail, comprising: providing an access point to the
medullary canal of said long bone, reducing the bone fragments at
the fracture, contacting the distal end of the barrel of an
implanting device for driving a fastener or fixation element into
bone with said access point, aligning the barrel of said device
with said medullary canal at said access point, and actuating the
trigger mechanism of said implanting device to deliver an IM nail
into said medullary canal, thereby fixing said bone fragments in
said reduced state, wherein said implanting device for driving a
fastener or fixation element into bone comprises: a chamber for
holding at least one fastener or fixation element, a barrel having
a proximal end and a distal end, wherein said proximal end is
connected to said chamber for propelling said fastener or fixation
element from said chamber, a propellant source functionally
connected to said chamber, and a triggering mechanism for releasing
propellant from said propellant source into said chamber and
charging said chamber in order to propel said fastener or fixation
element from said chamber through said barrel and driving said
fastener or fixation element into bone contacted with said distal
end.
[0008] Still another aspect of the present application relates to a
method for the fixation a fractured bone using at least one k-wire,
comprising: reducing at least one bone fragment with at least one
adjacent fragment or the main body of the bone, contacting the
distal end of the barrel of an implanting device for driving a
fastener or fixation element into bone with said at least one bone
fragment, said at least one adjacent fragment or said main body of
the bone, aligning the implanting device with said at least one
bone fragment and said at least one adjacent fragment or said main
body of the bone, and actuating the trigger mechanism of said
implanting device to deliver a k-wire affixing said at least one
bone fragment to said at least one adjacent fragment or the main
body of the bone, thereby fixing said at least one bone fragment in
said reduced state, wherein said implanting device for driving a
fastener or fixation element into bone comprises: a chamber for
holding at least one fastener or fixation element, a barrel having
a proximal end and a distal end, wherein said proximal end is
connected to said chamber for propelling said fastener or fixation
element from said chamber, a propulsion source functionally
connected to said chamber, and a triggering mechanism for releasing
propellant from said propulsion source into said chamber and
charging said chamber in order to propel said fastener or fixation
element from said chamber through said barrel and driving said
fastener or fixation element into bone contacted with said distal
end.
[0009] Yet another aspect of the present application relates to a
kit comprising an implanting device for driving a fastener or
fixation element into bone and a fastener or fixation element,
wherein said implanting device for driving a fastener or fixation
element into bone comprises: a chamber for holding at least one
fastener or fixation element, a barrel having a proximal end and a
distal end, wherein said proximal end is connected to said chamber
for propelling said fastener or fixation element from said chamber,
a propellant source functionally connected to said chamber, and a
triggering mechanism for releasing propellant from said propellant
source into said chamber and charging said chamber in order to
propel said fastener or fixation element from said chamber through
said barrel and driving said fastener or fixation element into bone
contacted with said distal end.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The accompanying drawings illustrate one or more embodiments
of the present application and, together with the written
description, serve to explain the principles of exemplary
embodiments of the present application.
[0011] FIG. 1 shows an embodiment of the device of the present
application.
DETAILED DESCRIPTION
[0012] The following detailed description is presented to enable
any person skilled in the art to make and use the device. For
purposes of explanation, specific nomenclature is set forth to
provide a thorough understanding of the present device and methods.
However, it will be apparent to one skilled in the art that these
specific details are not required to practice the making or use of
the device. Descriptions of specific applications are provided only
as representative examples. The present device and methods are not
intended to be limited to the embodiments shown, but is to be
accorded the widest possible scope consistent with the principles
and features disclosed herein.
[0013] One aspect of the present application relates to an
implanting device for inserting fasteners and fixation elements
into a bone. The present device propels a projectile in order to
introduce a fixation implant into a bone, either in a percutaneous
or in an open (exposed bone) manner.
[0014] As used herein, "reduction," "reduced" and "reducing" refer
to a medical procedure to restore a fracture to the correct
alignment by moving the fragments into contact with one another in
the correct position for bone healing.
[0015] A "fastener," as used herein, refers to an element that
partially embeds into bone or hard tissue to fasten or anchor
ligament, tendon or suture material to the bone. Examples of
fasteners include, but are not limited to suture anchors, pins,
screws and staples. Fasteners of the present application can be
composed of metal, plastic, bioabsorbable material, ceramic, other
suitable material or combinations thereof.
[0016] A "fixation element," as used herein, refers to an element
that completely partially embeds into bone, bone fragments or hard
tissue to fasten in order to immobilize reduced bone fragments in a
position where the fragments can grow together. Examples of
fixation elements include, but are not limited to k-wires and IM
nails. Fixation elements of the present application can be composed
of any suitable bicompatible material including, but not limited
to, metal alloys, plastic, bioabsorbable material, ceramic, or
combinations thereof.
[0017] The device of the present application can be used to drive
fasteners or fixation elements into and immobilize fragments of any
fractured bone in a mammalian body. In a particular embodiment,
said mammal is a human.
[0018] In particular embodiments, the bone is a long bone, having a
shaft and two extremities. Long bones are found in the limbs and
include the clavicle, humerus, radius, ulna, femur, tibia, fibula,
metacarpal and metatarsal bones, including the phalanges.
[0019] As used herein, the "proximal" end of a long bone refers to
the extremity of the bone closest to the center of the body when
the limb is extended. As used herein, the "distal" end of a long
bone refers to the extremity of the bone farthest from the center
of the body when the limb is extended. The device of the present
application may be used to immobilize the fragments of a fracture
at the proximal end of a long bone, the distal end of a long bone,
or the shaft of a long bone, or a combination thereof.
[0020] As used herein, the "proximal" end of a device, or a part of
a device, is the end that is towards the practitioner holding or
operating the device. As used herein, the "distal" end of a device,
or a part of a device, is the end that is towards the subject into
whom a fastener is to be delivered.
[0021] As used herein, the "distal" end of a fastener is the end of
the fastener that is oriented towards the subject into whom the
fastener is to be delivered, i.e., the end of the fastener that
makes the initial contact with the bodily tissue of the subject. As
used herein, the "proximal" end of a fastener is the end of the
fastener that is opposite the "distal" end of the fastener.
[0022] In other particular embodiments, the device of the present
application can be used to immobilize the fragments of a fractured
short bone, including the patella, sesamoid, carpal and tarsal
bones.
[0023] In further particular embodiments, the device of the present
application can be used to immobilize the fragments of a fractured
flat bone, including the skull, cranium, occipital, parietal,
frontal, nasal, lachrymal, vomer, scapula, os innominatum, sternum,
and rib bones.
[0024] In additional particular embodiments, the device of the
present application can be used to immobilize the fragments of a
fractured irregular bone, including the vertebrae, sacrum, coccyx,
temporal, sphenoid, ethmoid, malar, superior maxillary, inferior
maxillary, palate, inferior turbinated, and hyoid bones.
[0025] One aspect of the present application relates to a pneumatic
implanting device for driving a fastener or fixation element into
bone. The device comprises a chamber for holding at least one
fastener or fixation element, a barrel having a proximal end and a
distal end, wherein said barrel is for the delivery of the fastener
or fixation element into bone, and a triggering mechanism for
releasing a propulsion source.
[0026] In some embodiments, said fastener or fixation element is
selected from the group consisting of a Kirschner wire (k-wire), an
intramedullary nail (IM nail) or a suture anchor.
[0027] In one embodiment of the device, said proximal end of the
barrel is connected to said chamber for propelling said fastener or
fixation element from said chamber, a propulsion source
functionally connected to said chamber, and a triggering mechanism
for releasing propellant from said propulsion source into said
chamber and charging said chamber in order to propel said fastener
or fixation element from said chamber through said barrel and
driving said fastener or fixation element into bone contacted with
said distal end.
[0028] In another embodiment, the device further comprises a
replaceable cartridge for containing said at least one fastener or
fixation element in said chamber. In a further embodiment, said
cartridge is disposable. In another further embodiment, said
cartridge contains more than one fastener or fixation element.
[0029] In another embodiment, said propellant is a gas and said
propulsion source is a gas source. In some further embodiments,
said gas source is a tube that connects to an external gas supply.
In yet another further embodiment, said gas source is a replaceable
canister of compressed gas. In a related embodiment, said
compressed gas is medical grade air.
[0030] In still another embodiment, said propulsion source is an
explosive material and said propellant is the explosion of said
explosive material.
[0031] In particular embodiments, the device comprises a piston for
propelling a fastener or fixation element from the chamber, through
the barrel from the proximal to the distal end and into the bone.
In some embodiments, the piston has a proximal and a distal end and
the distal end comprises a concave depression, cup, slot or other
female-type feature into which the proximal end of the fastener or
fixation element inserts or locates in order to secure and/or
center the fastener or fixation element against the piston. In some
embodiments, the pressure of the propellant builds up proximal to
the piston in order to propel said piston in a distal direction
when the triggering mechanism is actuated.
[0032] In further embodiments, the piston comprises a retainer
mechanism that prevents the piston from exiting the distal end of
the barrel. In other embodiments, the piston is shaped such that
the distal-most portion thereof protrudes from the barrel upon
delivery of the fastener or fixation element into bone.
[0033] In other particular embodiments, the device lacks a piston,
wherein the fastener or fixation element fits into the barrel in
such a manner that the propellant is contained in contact with and
proximal to the fastener or fixation element. Upon actuation of the
triggering mechanism, said propellant drives said fastener or
fixation element in a proximal to distal direction down the barrel
into bone.
[0034] In another embodiment of the device, the device comprises a
compressed or loaded spring located proximal to said chamber as a
propulsion source and the release of the spring from compression or
loading is the propellant for driving said at least one fastener or
fixation element through said barrel into bone. In particular
embodiments, the device comprising a compressed or loaded spring
further comprises a piston for propelling a fastener or fixation
element from the chamber, through the barrel from the proximal to
the distal end and into the bone. In some embodiments, the piston
has a proximal and a distal end and the distal end comprises a
concave depression, cup, slot or other female-type feature into
which the proximal end of the fastener or fixation element inserts
or locates in order to secure and/or center the fastener or
fixation element against the piston. In some embodiments, the
tension of the compressed or loaded spring builds up proximal to
the piston in order to propel said piston in a distal direction
when the triggering mechanism is actuated. In further embodiments,
the piston comprises a retainer mechanism that prevents the piston
from exiting the distal end of the barrel. In other embodiments,
the piston is shaped such that the distal-most portion thereof
protrudes from the barrel upon delivery of the fastener or fixation
element into bone. In other particular embodiments, the device
comprising a compressed or loaded spring lacks a piston, wherein
the fastener or fixation element fits into the barrel in such a
manner that the compressed or loaded spring is in contact with and
proximal to the fastener or fixation element. Upon actuation of the
triggering mechanism releasing the spring, said compressed or
loaded spring drives said fastener or fixation element in a
proximal to distal direction down the barrel into bone.
[0035] In another embodiment of the device, the device comprises a
stretched elastic element and the contraction of said elastic
element is the propellant for driving said at least one fastener or
fixation element through said barrel into bone. In particular
embodiments, the device comprising a stretched elastic element
further comprises a piston for propelling a fastener or fixation
element from the chamber, through the barrel from the proximal to
the distal end and into the bone. In some embodiments, the piston
has a proximal and a distal end and the distal end comprises a
concave depression, cup, slot or other female-type feature into
which the proximal end of the fastener or fixation element inserts
or locates in order to secure and/or center the fastener or
fixation element against the piston. In some embodiments, the
tension of the stretched elastic element builds up proximal to the
piston in order to propel said piston in a distal direction when
the triggering mechanism is actuated. In further embodiments, the
piston comprises a retainer mechanism that prevents the piston from
exiting the distal end of the barrel. In other embodiments, the
piston is shaped such that the distal-most portion thereof
protrudes from the barrel upon delivery of the fastener or fixation
element into bone. In other particular embodiments, the device
comprising stretched elastic element lacks a piston, wherein the
fastener or fixation element fits into the barrel in such a manner
that the stretched elastic element is in contact with and proximal
to the fastener or fixation element. Upon actuation of the
triggering mechanism, said stretched elastic element drives said
fastener or fixation element in a proximal to distal direction down
the barrel into bone.
[0036] In still another embodiment of the device, the device
comprises a friction mechanism for driving a fastener or fixation
device in a proximal to distal direction down the barrel and into
bone. In some embodiments, said friction mechanism comprises at
least one wheel that contacts the side of said fastener or fixation
device, wherein rotation of said at least one wheel drives said
fastener or fixation device in a proximal to distal direction down
the barrel and into bone. In some embodiments, the device comprises
two wheels that are opposite one another, gripping said fastener or
fixation device between them. In some embodiments, the at least one
wheel is made from a flexible material including, but not limited
to, silicon, rubber, latex, plastic or a combination thereof,
including embodiments wherein one material is layered upon another
material. In some embodiments, the at least one wheel is made of a
rigid material, such as, but not limited to metal alloys, plastic
or ceramic. In some embodiments, the at least one wheel is made
from a rigid material coated with a flexible material. In other
embodiments, the at least one wheel is made of a rigid material and
is toothed, wherein the teeth grip notches in the sides of a
fastener or fixation device.
[0037] In yet another embodiment of the device, the device
comprises a cam and lever system for propelling at least one
fastener or fixation element from the device into bone.
[0038] In some embodiments, said triggering mechanism comprises a
means for regulating the propulsion source. For example, in some
embodiments thereof, regulating the pressure of the gas charging
said chamber. In other embodiments thereof, the triggering
mechanism regulates the amount of compression of the spring. In
still other embodiments thereof, the triggering mechanism regulates
the amount of contraction of the elastic element.
[0039] In yet another embodiment, said trigger mechanism comprises
a safety. In some further embodiments, said safety prevents
charging said chamber with gas when the distal end of said barrel
is not in contact with bone. In some further embodiments, said
safety mechanism prevents actuation of the trigger mechanism when
the distal end of said barrel is not in contact with bone.
[0040] In some embodiments, the barrel is interchangeable. For
example, in some procedures, several different diameters, sizes or
types of fasteners or fixation elements may be needed. In order to
facilitate delivery of said different fasteners or fixation
elements, barrels specific for a particular type of fastener or
fixation element can be inserted into or removed from the device.
For example, a barrel specific for the delivery of a K-wire may be
initially installed in the device, such that a K-wire can be driven
into bone. Subsequently, suture anchors may be needed for the
attachment of tendon. Accordingly, the practitioner can remove the
K-wire specific barrel from the device and replace it with a barrel
specific for a suture anchor of the desired size. In some
embodiments, the interchangeable barrels for the device are
disposable.
[0041] In some embodiments, the device comprises an openable breach
proximal to the barrel. Said openable breach allows the direct
loading of at least one fastener or fixation element into the
chamber or barrel. In some embodiments, the interchangeable barrel
is installed into or removed from the device through the openable
breach.
[0042] In some embodiments, an implanting device of the present
application is sterilizable. In other embodiments, an implanting
device of the present application is disposable.
[0043] Another aspect of the present application relates to a
method for the fixation of a fractured bone using the implanting
device of the application.
[0044] In one embodiment, the method comprises fixation of bone
fragments of a long bone using an IM nail. The method comprises the
steps of: providing an access point to the medullary canal of said
long bone, reducing the bone fragments at the fracture, aligning
the implanting device with said medullary canal at said access
point, and actuating the trigger mechanism of said implanting
device to deliver an IM nail into said medullary canal, thereby
fixing said bone fragments in said reduced state. In some
embodiments, said access point is percutaneous. In other
embodiments, said access point is open.
[0045] In a further embodiment, said access point is a hole in the
bone. In a still further embodiment, said hole is created with a
drill. In another still further embodiment, said hole is created
with an awl.
[0046] In another further embodiment, said long bone is selected
from the group consisting of metatarsal bones and metacarpal bones,
wherein said metatarsal bones and metacarpal bones include the
phalanges.
[0047] In another embodiment, the method comprises fixation of bone
fragments of a bone using at least one k-wire. The method comprises
the steps of reducing at least one bone fragment with at least one
adjacent fragment or the main body of the bone, aligning the
implanting device with said at least one bone fragment and said at
least one adjacent fragment or the main body of the bone, and
actuating the trigger mechanism of said implanting device to
deliver a k-wire affixing said at least one bone fragment to said
at least one adjacent fragment or the main body of the bone,
thereby fixing said at least one bone fragment in said reduced
state.
[0048] In a further embodiment, said bone is the humerus. In a
still further embodiment, said at least one bone fragment is from
the proximal end of the humerus.
[0049] In another further embodiment, said bone is the femur. In a
still further embodiment, said at least one bone fragment is from
the head of the femur.
[0050] In yet another further embodiment, said bone is a carpal
bone or a tarsal bone.
[0051] In some further embodiments, the method comprises fixing two
or more bones together to facilitate healing of ligaments. In some
embodiments, the two or more bones are carpal bones or tarsal
bones.
[0052] In some embodiments, the proximal end of the K-wire is left
protruding from the bone. In a further embodiment, a cross-pin
fixation device is attached to the protruding proximal ends of the
K-wires for further reduction or stabilization of the fracture.
[0053] Another aspect of the present application relates to a kit
comprising an implantation device of the present application and a
fastener or fixation element.
[0054] In one embodiment, the fastener or fixation element is
selected from the group consisting of a k-wire, an IM nail, bone
screw and a suture anchor. In some embodiments, the kit further
comprises a biocompatible filler or adhesive material.
[0055] In another embodiment, the kit further comprises a
replaceable cartridge for containing said at least one fastener or
fixation element in said chamber. In a further embodiment, said
cartridge is disposable. In another further embodiment, said
cartridge contains more than one fastener or fixation element.
[0056] In another embodiment, said implantation device is
pneumatic. In a further embodiment, said kit further comprises a
propellant cartridge. In some embodiments, the propellant is
compressed air.
[0057] FIG. 1 is a schematic view of one embodiment of the
implanting device 100. In some embodiments, the implanting device
100 is sterilizable. In other embodiments, the implanting device
100 is disposable.
[0058] The implanting device 100 comprises a barrel 110 for
propelling the fastener or fixation element into the bone, which is
placed in contact with, or in proximity to, the distal end 115 of
the barrel 110. The device further comprises a chamber 120 which
holds the fastener or fixation element.
[0059] In some embodiments, the fastener or fixation element is
held within a replaceable cartridge 180 that is inserted into the
chamber 120. In some embodiments, the cartridge holds a single
fastener or fixation element. In other embodiments, the cartridge
holds multiple fasteners or fixation elements 185. In particular
embodiments, the cartridge is disposable.
[0060] In some embodiments, the device is adapted to be used with a
single type of fastener or fixation device. In other embodiments,
the device is usable with multiple types fasteners or fixation
devices. In further embodiments, the fasteners or fixation devices
include, but are not limited to k-wires, IM nails, screws and
suture anchors.
[0061] In particular embodiments, the fasteners or fixation
elements, or the cartridge that holds fasteners or fixation
elements, is inserted into the implanting device 100 through an
access panel 130 at the proximal end 135 of the implanting device
100.
[0062] Pressure for propelling a fastener or fixation element down
the barrel 110 of the implanting device 100 is provided through a
fitting 140 that is affixed to the chamber 120. In some
embodiments, the fitting 140 comprises a tube. In other
embodiments, the fitting 140 comprises a coupling for attaching to
a gas source that provides a medically acceptable propellant gas.
In still other embodiments, the fitting 140 comprises both a tube
and a coupling.
[0063] In some embodiments, the gas source is an external source.
In other embodiments, the gas source is a replaceable gas cartridge
150. In some embodiments, the replaceable gas cartridge 150 is
insertable into the handle 160 of the implanting device 100. In
some embodiments, the replaceable gas cartridge 150 is insertable
through a port in the end 165 of the handle 160. In other
embodiments, the replaceable gas cartridge 150 is insertable into a
socket in the side or back of the handle 160.
[0064] In some embodiments, the medically acceptable propellant gas
is medical grade compressed air. In still other embodiments, the
medically acceptable propellant gas comprises nitrogen, oxygen or
carbon dioxide. In some embodiments the replaceable gas cartridge
150 is reusable. In other embodiments, the replaceable gas
cartridge 150 is disposable.
[0065] The chamber 120 is charged with propellant gas from the
fitting 140 by actuation of a trigger mechanism 170. Actuation of
the trigger mechanism 170 allows the propellant gas to propel a
fastener or fixation element down the barrel 110 and into the bone
that is in contact with, or in proximity to, the distal end 115 of
the barrel 110.
[0066] In some embodiments, the trigger mechanism 170 further
comprises a control element for adjusting the pressure of the
propellant gas that is released into the chamber 120.
[0067] Also, in some embodiments, the implanting device 100
comprises a safety mechanism 190 such that the distal end of the
barrel 115 must be in contact with tissue in order for the
implanting device 100 to operate. In some embodiments, unless the
distal end of the barrel 115 is in contact with tissue, the trigger
mechanism 170 cannot be actuated. In other embodiments, unless the
distal end of the barrel 115 is in contact with tissue, the trigger
mechanism 170 can be actuated, but the chamber 120 is not charged
with propellant gas from the fitting 140.
[0068] In some other embodiments, the power for propelling a
fastener or fixation element down the barrel of the implanting
device 100 is provided by a mechanical device such as a spring, an
electrical device such as a battery powered piston, or through a
controlled explosion like in a firearm.
[0069] The present application is further illustrated by the
following examples which should not be construed as limiting. The
contents of all references, patents and published patent
applications cited throughout this application, as well as the
Figures and Tables, are incorporated herein by reference.
EXAMPLE 1
Reduction and Fixation of Fractured Metacarpal Bone
[0070] A male subject presents with a fracture near the distal end
of the second metacarpal bone on the left hand. The hand is x-rayed
and the nature of the fracture indicates implantation of a
bioabsorbable IM nail as the desired therapeutic approach.
[0071] The metacarpophalangeal joint is flexed 90 degrees exposing
the metacarpal head, allowing direct access by the fixation device.
The fracture is reduced and held in place and the trigger mechanism
of the fixation device is actuated, firing the IM nail through the
metacarpal head into the medullary canal of the phalanx,
immobilizing the reduced fragments of the metacarpal in the correct
position to allow union of the fragments at the fracture. The
excess wire protruding is pulled out 4 mm proximally and trimmed
and then tapped in all the way underneath the subcohondral
bone.
EXAMPLE 2
Reduction and Fixation of Fractured Patella
[0072] A male subject presents with a fractured left patella. The
knee is x-rayed and it is found that the patella is broken
transversely into upper and lower fragments. The decision is made
to reduce the fracture and immobilize the fragments with k-wires
using a tension band procedure.
[0073] Briefly, a longitudinal incision is made over the patella
and the patella is exposed. The fracture is reduced and held in
place with a tenaculum having the pincers contacting the top and
bottom of the patella along the centerline.
[0074] The implanting device, loaded with a cartridge comprising 2
mm diameter k-wires is contacted with the top of the patella and to
one side of the tenaculum pincer. The implanting device is aimed to
fire through both fragments of the patella such that the distal end
of a first k-wire will protrude through the bottom of the patella.
The trigger mechanism is actuated, forcing the first k-wire through
the patella. The implanting device is moved to the top edge of the
patella on the other side of the tenaculum pincer and a second
k-wire is driven through the patella, parallel to the first.
[0075] A thin k-wire is passed behind the proximal ends of the 2
mmk-wires protruding from the top of the patella. The two ends of
the thin k-wire are crossed over one another in front of the
patella and one end is passed behind the distal ends of the 2 mm
k-wires protruding from the bottom of the patella. The two ends of
the thin wire are brought together in front of the patella and
twisted together until completely taut. The distal ends of the 2 mm
k-wires are trimmed and bent over the thin k-wire to secure it. The
proximal ends of the 2 mm k-wires are also trimmed and soft tissue
caps are placed over them. The incision over the patella is sutured
closed.
[0076] The above description is for the purpose of teaching the
person of ordinary skill in the art how to practice the present
application, and it is not intended to detail all those obvious
modifications and variations of it which will become apparent to
the skilled worker upon reading the description. It is intended,
however, that all such obvious modifications and variations be
included within the scope of the present application, which is
defined by the following claims. The claims are intended to cover
the components and steps in any sequence which is effective to meet
the objectives there intended, unless the context specifically
indicates the contrary.
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