U.S. patent application number 12/809030 was filed with the patent office on 2011-01-06 for orthopaedic implants.
Invention is credited to Adam S. Hacking, Edward J. Harvey, Corey Richards.
Application Number | 20110004317 12/809030 |
Document ID | / |
Family ID | 40795142 |
Filed Date | 2011-01-06 |
United States Patent
Application |
20110004317 |
Kind Code |
A1 |
Hacking; Adam S. ; et
al. |
January 6, 2011 |
ORTHOPAEDIC IMPLANTS
Abstract
A method for making an orthopaedic implant, the method
comprising: characterizing at least a portion of a bone
corresponding to the bone to be replaced, said corresponding bone
being on the contralateral side of the patient; providing a model
of the orthopaedic implant based on a mirror image of the
contralateral bone; and forming the orthopaedic implant based on
the model.
Inventors: |
Hacking; Adam S.;
(Somerville, MA) ; Harvey; Edward J.; (Montreal,
CA) ; Richards; Corey; (Queensland, AU) |
Correspondence
Address: |
KLARQUIST SPARKMAN, LLP
121 SW SALMON STREET, SUITE 1600
PORTLAND
OR
97204
US
|
Family ID: |
40795142 |
Appl. No.: |
12/809030 |
Filed: |
December 17, 2008 |
PCT Filed: |
December 17, 2008 |
PCT NO: |
PCT/CA08/02179 |
371 Date: |
September 3, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61008173 |
Dec 18, 2007 |
|
|
|
Current U.S.
Class: |
623/21.11 ;
600/416; 606/79 |
Current CPC
Class: |
A61F 2002/30069
20130101; A61F 2310/00179 20130101; A61F 2002/30943 20130101; A61F
2002/30957 20130101; A61B 6/505 20130101; A61B 2034/102 20160201;
A61F 2002/30948 20130101; A61B 17/15 20130101; A61F 2/4261
20130101; A61F 2002/4289 20130101; A61F 2002/2871 20130101; A61F
2240/004 20130101; B33Y 80/00 20141201; B33Y 50/00 20141201; A61F
2310/00011 20130101; A61F 2/28 20130101; Y10T 29/49 20150115; A61F
2/30942 20130101 |
Class at
Publication: |
623/21.11 ;
600/416; 606/79 |
International
Class: |
A61F 2/42 20060101
A61F002/42; A61B 5/05 20060101 A61B005/05; A61B 17/16 20060101
A61B017/16 |
Claims
1-64. (canceled)
65. An implant for replacing a bone in a wrist, hand, ankle or foot
of a patient, said implant having a body which is sized and shaped
to anatomically replicate the bone being replaced and which is
based on a mirror image of a corresponding bone on a contralateral
side of the patient.
66. An implant according to claim 65, wherein the implant body
includes at least one attachment element for attaching the implant
to soft or hard tissue at a site of implantation in use, the
attachment element being an opening formed through the implant body
for receiving a fixing element.
67. An implant according to claim 65, wherein the implant has an
articulating surface which has a topography corresponding to that
of a surface against which the implant will articulate or to a
surface of a corresponding bone on a contralateral side of the
patient.
68. An implant according to claim 65, wherein the bone being
replaced is a scaphoid or a lunate bone of a wrist, the implant
being surgically insertable at an implantation site adjacent a
radius bone, the implant body having an articulating surface for
articulation against at least a portion of an articulating surface
of the radius bone.
69. An implant according to claim 65, further comprising a
component for replacing at least a portion of a surface of a bone
articulating against the implant in use, the component comprising a
component body and a component surface, the component surface
corresponding substantially in topography to the portion of the
surface of the articulating bone which the component is replacing,
to a corresponding contralateral bone, or to an articulating
surface of the implant.
70. An implant according to claim 69, wherein the component body
includes at least one component attachment element for attaching
the component to the articulating bone, wherein the at least one
component attachment element includes at least one opening formed
through the component body for receiving a fixing element.
71. An implant according to claim 69, wherein the component is
sized and shaped to replace at least a portion of a radius bone of
a wrist of the patient.
72. A method for making an implant for replacing a bone in a wrist,
hand, ankle or foot of a patient, the method comprising:
characterizing at least a portion of a bone corresponding to the
bone to be replaced, said corresponding bone being on the
contralateral side of the patient; providing a three-dimensional
digital model of the implant based on a mirror image of the
contralateral bone; and forming the implant based on the
three-dimensional digital model.
73. A method according to claim 72, wherein the characterizing of
the contralateral bone comprises imaging the portion of the
contralateral bone corresponding to the bone to be replaced using
Magnetic Resonance Imaging or Computed Tomography.
74. A method according to claim 72, further comprising
characterizing a surface topography of an articulating bone
intended to articulate with a surface of the bone to be replaced,
and applying the characterized surface topography to the
three-dimensional digital model or to the implant.
75. A method according to claim 72, further comprising adding an
attachment element to the three-dimensional digital model or to the
implant, the attachment element being at least one opening in the
implant for receiving a fixing element to attach the implant to
surrounding soft or hard tissue in use.
76. A method according to claim 72, wherein the implant is for
replacing at least a portion of a scaphoid, a lunate or a radius
bone in the patient.
77. A method according to claim 72, wherein the implant is formed
from the three-dimensional digital model by stereolithography.
78. A device for preparing a bone in a wrist hand, ankle or foot of
a patient prior to resurfacing the bone; the device comprising a
first face arranged to abut a distal end of the bone, and a second
face arranged to abut a side of the distal end of the bone, the
first face comprising a first slot extending to the second face to
define a first cutting edge, and the second face comprising a
second slot extending across the second face to intersect the first
slot to define a second cutting edge.
79. A device according to claim 78, wherein the bone being
resurfaced is a radius bone of a wrist.
80. A device according to claim 78, further comprising at least one
opening formed through the first or the second faces for securing
the device to the bone.
81. A device according to claim 78, further comprising at least one
securing element for being received in the at least one opening to
secure the device to the bone.
82. A device according to claim 78, wherein the first face is at
substantially 90.degree. to the second face.
83. A device according to claim 78, wherein the first and second
faces abut different faces of the distal end of the bone.
Description
FIELD OF THE INVENTION
[0001] The invention relates generally to orthopaedic implants,
methods of making the orthopaedic implants, methods of implanting
the orthopaedic implants, devices for implanting the orthopaedic
implants and devices for assisting cutting bone.
BACKGROUND OF THE INVENTION
[0002] Damaged or diseased bones and joints in human and animal
patients give rise to pain and decreased joint mobility. It is
known to totally or partially replace these bones and joints with
artificial implants to alleviate the painful symptoms and restore
some degree of mobility.
[0003] The replacement of bones in the wrist has had limited
success because of the complexity and multitude of bones, tendons
and ligaments in the wrist. As can be seen in FIG. 1, there is a
first row of wrist bones, known as a first carpal row or proximal
carpal row, adjacent a radius bone and an ulnar bone. The proximal
carpal row includes a scaphoid bone, a lunate bone, a triquetrum
bone and a pisiform bone. A second row of bones, known as a distal
carpal row, includes a trapezium bone, a trapezoid bone, a capitate
bone and a hamate bone. The scaphoid bone is surrounded by the
trapezium, trapezoid, capitate and lunate bones and articulates at
the proximal side with a radius bone of the arm, at the distal side
with the trapezium and trapezoid of the proximal carpal row, and
medially about the lunate and capitate bones. The distal end of the
radius bone has a scaphoid fossa, which faces the scaphoid, and a
lunate fossa which faces the lunate bone. A ridge separates the
scaphoid and the lunate fossas.
[0004] The ligaments of the wrist are illustrated in FIGS. 2A and
2B for two different patients demonstrating the complexity of the
wrist anatomy and the variability of the wrist anatomy between
different patients. These ligaments include the radial collateral
ligament (RC), the radioscaphocapitate ligament (RSC), the
radiolunate ligament (RL), the ulnolunate ligament (UL), the
ulnocarpal meniscus homologue (M), the lunotriquetral ligament
(LT), the deltoid ligament (V), dorsal scapholunate ligament (SL),
dorsal interior circular muscle unit (DIC), ulnar collateral (UC),
radioscapholunate ligament (RSL), trapezoid-trapezium (TT),
trapezoid-capitate (TC), capitohamate (CH), radioscaphoid (RS),
radiotriquetral (RT). The Volar FCR tendon and the volar capsule
also form part of the wrist anatomy but are not shown in FIGS. 2A
and 2B.
[0005] Replacement of some of the bones of the wrist may be
required to treat bone fractures, or diseases such as arthritis
which affects the radius joint of the wrist. Arthritis more
commonly affects elderly patients and results in painful joints,
and may be so severe that the pain cannot be managed with pain
medication and the arthritic hand cannot be used to lift weight.
Wrist bone fractures, seen typically in younger patients, occur
most often in the scaphoid bone. Damage or degeneration to the
scaphoid bone can also occur through conditions other than
fracture. The scaphoid bone is particularly difficult to heal since
blood supply to the scaphoid bone is provided only by vessels on
the distal side. If not treated properly or detected early, a
scaphoid bone fracture can lead to bone necrosis.
[0006] Total or partial wrist replacements are known to treat
arthritis in the wrist and involve the replacement of several bones
in the wrist using a total wrist replacement prosthesis formed from
biomaterials such as metal, polypropylene or silicone elastomers.
In one known total wrist replacement system, the bones of the first
carpal row are removed and replaced by an implant which fuses
together the bones above the first carpal row and which has an
articulating surface for articulating against the radius or a
surface implant replacing the surface of the radius. With this type
of replacement, the pain may be somewhat alleviated although
patients can not retain full functional flexibility and use of
their hand. These types of replacements can also loosen through
trauma or injury sustained through a fall, for example, or through
wear, and therefore require replacement. Partial wrist replacements
are a less severe type of replacement. A known partial wrist
replacement technique involves the replacement of the scaphoid and
lunate bones of the proximal carpal row with an implant which
functions as a spacer to maintain the relationship of adjacent
carpal bones after excision of the scaphate or lunar bones.
[0007] The known early treatment for scaphoid bone fracture is
anatomic reduction with internal fixation. Known fixation devices
include Herbert's screw, the Acutrack Acumed.TM. screw, as well as
other screw types. Typically, the fractured scaphoid bone and/or
its fragments are removed and some of the remaining bones are fixed
to one another using one or more screws. Clearly, this can restrict
the range of movement of the patient's wrist and is not ideal. Late
treatment involves the treatment of resultant arthritis with a
partial or total wrist replacement. Ligament injury between the
scaphoid and lunate is often missed and the most common treatment
is partial or total wrist replacement.
[0008] The bones of the human or animal foot can suffer from
similar damage or diseases as the wrist. As for the wrist, there is
a lack of effective treatment for damaged or diseased foot bones
and ligaments.
[0009] Therefore, it is desired to overcome or reduce at least some
of the above-described problems.
SUMMARY OF THE INVENTION
[0010] The present invention reduces the difficulties and
disadvantages of the aforesaid designs and treatments.
[0011] From one aspect, there is provided a method for making an
orthopaedic implant, the method comprising characterizing at least
a portion of a bone corresponding to the bone to be replaced, said
corresponding bone being on the contralateral side of the patient;
providing a model of the orthopaedic implant based on a mirror
image of the contralateral bone; and forming the orthopaedic
implant based on the model. The dimensions of the body of the
implant can correspond substantially with the contralateral bone of
the bone being replaced as it has been found that for some bones of
the human or animal body, the contralateral bones are mirror images
of one another.
[0012] Advantageously, the model is a three-dimensional image, and
the characterizing comprises imaging the at least a portion of the
bone corresponding to the bone to be replaced using Magnetic
Resonance Imaging or Computed Tomography, or the like.
[0013] Optionally, the model may be processed before forming the
orthopaedic implant. The processing may include modifying a surface
feature such as applying a surface topography. The surface
topography to be applied can be based on an articulating surface
topography of an articulating bone intended to articulate with a
surface of the bone to be replaced, the method further comprising
characterizing the articulating surface topography of the adjacent
bone and applying the characterized surface topography to the
model.
[0014] The processing may also include adding an attachment element
to the model, the attachment element being at least one opening in
the orthopaedic implant for attaching the orthopaedic implant to
surrounding soft or hard tissue in use. Alternatively, the
attachment element, such as at least one opening, may be formed on
the orthopaedic implant.
[0015] Preferably, the orthopaedic implant is formed from the model
by stereolithography. Therefore, the orthopaedic implant can be
easily and relatively inexpensively manufactured from suitable
biocompatible materials.
[0016] In one embodiment, the bone being replaced is the scaphoid
bone.
[0017] In another embodiment, the method further comprises making a
replacement articulating component for articulating against a
portion of the orthopaedic implant in use, the method comprising:
providing a model of an articulating bone to be replaced; and
forming the replacement articulating component from the model.
[0018] Advantageously, providing the model of the articulating bone
includes imaging the articulating bone or the patient's
contralateral articulating bone. The model can be a 3D digital
model.
[0019] The method can further comprise processing the model before
forming the replacement articulating component. The processing can
include modifying a surface to apply a surface topography by
characterizing a surface topography of the articulating bone or the
patient's contralateral articulating bone and applying it to the
model.
[0020] Optionally, at least one attachment element can be formed on
the model or on the replacement articulating component. Preferably,
the at least one attachment element is an opening formed through
the replacement articulating component for receiving a fixation
device, such as a nail or a screw.
[0021] The model can also be processed to adjust the outer
dimensions of the model to minimize the amount of bone being
replaced. In this way, trauma to the surrounding is minimized.
[0022] From another aspect, there is provided an implant for
replacing bone, said implant having a body which is sized and
shaped to anatomically replicate the bone being replaced and which
is based on a mirror image of a corresponding bone on a
contralateral side of a patient. Advantageously, the implant body
includes at least one attachment element for attaching the implant
to soft or hard tissue at a site of implantation in use. The at
least one attachment element can be an opening formed through the
implant body.
[0023] In one embodiment, the bone being replaced is a scaphoid
bone of a wrist, the implant being surgically insertable at an
implantation site adjacent trapezium, trapezoid, lunate, capitate
and radius bones, the implant body having a capitate articulating
surface, a radius articulating surface and a lunate articulating
surface. The outer dimensions of the implant are based on outer
dimensions of a scaphoid bone on the contralateral side of the
patient. The surface topography of the radius articulating surface
of the scaphoid implant is based on a surface topography of a
corresponding articulating surface of the radius bone or a
corresponding articulating surface of a contralateral radius
bone.
[0024] The implant may further comprise a component for replacing
at least a portion of a surface of a bone articulating against the
implant in use, the component comprising a component body and a
component surface, the component surface corresponding
substantially in topography to the portion of the surface of the
articulating bone which the component is replacing, to a
corresponding contralateral bone, or to an articulating surface of
the implant. Preferably, the component body includes at least one
component attachment element, such as an opening formed through the
component body, for attaching the component to the articulating
bone.
[0025] In one embodiment, the component is arranged to replace at
least a portion of the radius bone which articulates against the
radius articulating surface of the implant in use.
[0026] From a yet further aspect, there is provided an implant for
replacing at least a portion of a radius bone of a patient, the
implant comprising a radius implant body and a radius implant
surface, the radius implant surface corresponding substantially in
topography to the portion of the radius bone which the implant is
replacing, or to a corresponding articulating surface in use.
Preferably, the radius implant body includes at least one radius
implant attachment element, such as an opening formed through the
radius body, for attaching the implant to the radius bone.
[0027] From yet another aspect, there is provided a method for
replacing a scaphoid bone of a patient with an implant as described
above, the method comprising: removing the scaphoid bone to be
replaced at a site of implantation; placing the implant at the site
of implantation; and stabilizing the implant in position.
Preferably, the implant comprises at least one opening formed in a
body of the implant, the method further comprising stabilizing the
implant by securing a ligament, tendon or other soft tissue element
at the implantation site through the opening. In one embodiment,
the method further comprises attaching a dorsal interior circular
muscle unit (DIC) ligament to a flexor carpi radialis (FCR) tendon
through a first implant opening, and attaching a scapholunate
ligament (SL) to a volar capsule through a second implant opening.
The implant can be surgically positioned through relatively simple
surgical procedures which minimizes surgery time to the benefit to
the patient and to the hospital.
[0028] From another aspect, there is provided a device for guiding
the excision of a portion of an end of a bone; the device
comprising a first face arranged to abut an end of the bone, and a
second face arranged to abut a side of the end of the bone, the
first face comprising a first slot extending to the second face to
define a first cutting edge, and the second face comprising a
second slot extending across the second face to intersect the first
slot to define a second cutting edge. The device can also include
at least one attachment element, such as an opening formed through
either the first or the second faces, for securing the device to
the bone. In one embodiment, the first face is at substantially
90.degree. to the second face. This is suited for excising the
distal end of a radius bone. However, different angles are possible
according to the shape of the end of the bone being excised.
[0029] There is also provided a method for excising a portion of an
end of a bone, the method comprising: placing a device as described
above over the end of the bone; securing the device in position on
the bone; inserting a cutting device into the first or second slot
of the device and guiding the cutting device along an edge of the
slot to cut the bone along the first and second slots.
[0030] From yet another aspect, there is provided a device for
guiding the cutting of slices of bone, the device comprising a
first face for abutting an end of a bone, and a second face for
abutting a side of the end of the bone, a slot for receiving and
guiding a cutting device extending across the second face, the slot
being spaced from the first face for cutting a slice of the bone
from the end of the bone. The device preferably comprises at least
one attachment element for securing the device to the bone. The
attachment element can be an opening formed through either the
first or the second faces for receiving a fixation device such as a
wire, nail or screw. In one embodiment, for slicing bone from a
distal end of a radius bone, the first face is at substantially
90.degree. to the second face. However, this angle may vary
depending on the application.
[0031] There is also provided a method for excising a sliver of a
bone from an end of the bone, the method comprising placing a
device as described above over the end of the bone; securing the
device in position on the bone; and inserting a cutting device into
the slot and guiding the cutting device along an edge of the slot
to cut the bone along the slot.
[0032] According to another aspect, there is provided a device for
cutting a sliver of a bone, said device comprising: a body portion
having two open ends and a bore extending between the two open ends
for receiving a piece of the bone from which the sliver is to be
cut, the body portion comprising a slot for receiving and guiding a
cutting device for cutting the piece of bone in the bore; an end
portion for closing one open end of the bore and for supporting the
piece of bone when received in the bore; and a plunger portion
receivable in the other open end of the bore for keeping the piece
of bone in position whilst the sliver is cut from the piece of
bone. Using this device, if too much bone has been excised, a
sliver of bone can be cut from a piece of cut bone and re-attached
to the cut surface of the bone.
[0033] Also provided is a method for cutting a sliver from a piece
of bone, said method comprising: inserting the piece of bone in the
bore of the body portion of the device as described above whilst
the end portion closes one of the ends of the body portion;
inserting the plunger portion through the other end of the body
portion to secure the bone piece in position; and inserting a
cutting edge of a cutting device in the slot and guiding the
cutting edge along the slot to cut a sliver of the bone.
[0034] From yet another aspect, there is provided a method for
replacing at least a portion of a radius bone of a patient with an
implant as described above, the method comprising excising the
portion of the radius bone to be replaced using a device or a
method as described above; placing the implant at the site of
implantation; and stabilizing the implant in position. Preferably,
the implant is stabilized by at least one fixation element, such as
screws or nails received through openings in a body of the implant,
to secure the implant to the surrounding radius bone. In one
embodiment, the scaphoid bone is removed prior to excising the
radius bone portion, and the scaphoid bone is replaced with an
implant as described above after the portion of the radius bone has
been replaced. This provides more space around the distal end of
the radius bone for the excision and surface replacement of the
radius bone.
[0035] From a yet further aspect, there is provided a method for
replacing at least a portion of a radius bone of a patient with an
implant as described above, the method comprising excising the
portion of the radius bone to be replaced; placing the implant at
the site of implantation; and stabilizing the implant in position.
Advantageously, the implant is stabilized by fixation elements
engaging with the implant to secure the implant to the surrounding
radius bone. The fixation elements can be screws or nails received
through openings in a body of the implant. In one embodiment, a
scaphoid bone is removed prior to excising the radius bone portion.
The scaphoid bone can then be replaced with an implant as described
above after the portion of the radius bone has been replaced.
[0036] Yet further aspects of the invention are the use of an
implant as described above for replacing damaged bones such as a
scaphoid bone and/or a radius bone of a wrist of a patient, and the
use of a device as described above for preparing a radius bone for
implantation of a radius implant.
[0037] Inventors have found that custom scaphoid arthroplasties
based on images of the scaphoid bone of the contralateral wrist
(mirror image) using computed tomography or magnetic resonance
scans produce an anatomical replica of the bone being replaced.
Replacing the scaphoid bone alone eliminates the need for surgery
with a Herbert screw or a wrist fusion or replacement. Therefore,
the damaged scaphoid bone can be replaced immediately or soon after
an accident, rather than at a later date, which would limit the
risk of developing arthritis later on. The invention could also
apply to other damaged bones in the wrist and foot to avoid
performing a total wrist replacement or other treatments to the
hand and foot.
[0038] The feature of the attachment element on the implant
provides a way of stabilizing the implant at the implantation site
and attaching the implant to nearby soft or hard tissue.
Specifically, sutures or other attachment devices can be used to
secure ligaments and tendons to the implant, and in turn secure
these to the capsular tissue.
[0039] Replacing the scaphoid bone alone is new and opens the
possibility of treating younger patients with arthritis. By means
of the invention, the treatment of damaged bone such as fractured
bone and bone defects will be easier and cheaper to carry out. The
implant of the embodiments of the invention has the potential for
permitting improved wrist motion with increased stability, mobility
and freedom from pain compared to prior art implants. By implanting
an anatomical replica of the scaphoid bone of the patient being
replaced, arthritis or other diseases or mechanical problems of the
wrist are avoided. It is believed that the scaphoid implant does
not alter the natural healthy biomechanics of the patient's
wrist.
[0040] Benefits might be very important for young patients that do
not have any option at the moment as well as for elderly patients
that could avoid a total wrist arthroplasty. The present invention
is in line with a new trend of ambulatory/less invasive surgery. An
implant is provided that will fit the patient's anatomy based on
the mirror image of the contralateral wrist. The implant also has
specific regions to fix ligaments. It is unlike existing
replacements which are non-anatomic and involve the removal of
healthy bones. The embodiments of the invention are envisaged to
have application in various orthopaedic procedures, such as wrist
and ankle surgery.
BRIEF DESCRIPTION OF THE DRAWINGS
[0041] Further aspects and advantages of the present invention will
become better understood with reference to the description in
association with the accompanying drawings in which:
[0042] FIG. 1 is a schematic illustration of the principal bones of
a wrist of a human right hand when viewed from the palm side of the
right hand;
[0043] FIGS. 2A and 2B illustrate the tendons and ligaments of the
human wrist for two different patients;
[0044] FIGS. 3A to 3F illustrate (A) an anterior view, (B) a distal
view, (C) another anterior view, (D) a lateral view, (E) a medial
view and (F) a posterior view, of an implant according to one
embodiment of the present invention;
[0045] FIG. 4 illustrates a method of making the implant of FIGS.
3A to 3F according to an embodiment of the present invention;
[0046] FIGS. 5A, 5B and 5C are x-rays of a human wrist with
indications of location of the volar FCR tendon and capsule, the
dorsal DIC and SL ligaments, and the ends of the dorsal DIC and SL
ligaments which are attachable to the implant of FIGS. 3A to
3F;
[0047] FIG. 6 illustrates the implant of FIGS. 3A to 3F in use;
[0048] FIGS. 7A and 7B illustrate an orthopaedic implant according
to another embodiment of the present invention when viewed from (A)
an articulating surface, and (B) a non-articulating surface;
[0049] FIG. 8 illustrates a method of making the orthopaedic
implant of FIGS. 7A and 7B according to an embodiment of the
present invention;
[0050] FIG. 9 illustrates an MRI of a patient's radius to be
partially replaced by the orthopaedic implant of FIGS. 7A and 7B
according to the method of FIG. 8;
[0051] FIG. 10 illustrates a model of the patient's radius based on
the MM of FIG. 9;
[0052] FIGS. 11A and 11B illustrate processed images of the model
of FIG. 10;
[0053] FIGS. 12A to 12I illustrate further processing of the model
of FIG. 10 to arrive at the final model of the orthopaedic implant
of FIGS. 7A and 7B;
[0054] FIGS. 13A to 13D illustrate (A) an anterior, (B) a lateral,
(C) a posterior and (D) a perspective view of the orthopaedic
implant of FIGS. 7A and 7B in use;
[0055] FIG. 14 illustrates a perspective view of a first device
according to an embodiment of the present invention for preparing a
bone for implantation of the orthopaedic implant of FIGS. 7A and
7B;
[0056] FIG. 15 illustrates a plan view of a plate portion of the
first device of FIG. 14;
[0057] FIG. 16 illustrates a first end view of the first device of
FIG. 14;
[0058] FIG. 17 illustrates a second end view of the first device of
FIG. 14;
[0059] FIGS. 18A to 18F illustrate use of the first device of FIG.
14 to implant the orthopaedic implant of FIGS. 7A and 7B;
[0060] FIG. 19 illustrates a perspective view of a second device
according to an embodiment of the present invention for preparing a
bone for implantation of the orthopaedic implant of FIGS. 7A and
7B;
[0061] FIG. 20 illustrates a plan view of a plate portion of the
second device of FIG. 19;
[0062] FIG. 21 illustrates a first end view of the second device of
FIG. 19;
[0063] FIG. 22 illustrates a second end view of the second device
of FIG. 19;
[0064] FIG. 23 is a perspective view of a third device according to
an embodiment of the present invention for preparing a bone for
implantation of the orthopaedic device of FIGS. 7A and 7B;
[0065] FIG. 24 is a close-up view of a portion of one side of the
device of FIG. 23;
[0066] FIG. 25 is a close-up view of a portion of another side of
the device of FIG. 23;
[0067] FIGS. 26 to 28 are x-rays of (A) a contralateral human
wrist, and (B) the corresponding wrist having an implanted
orthopaedic implant according to an embodiment of the present
invention according to FIGS. 3A to 3F and 7A and 7B, and as
described in Example 1; and
[0068] FIG. 29 illustrates the geometry of a scaphoid bone and its
mirror image with its contralateral scaphoid bone according to
Example 2.
DETAILED DESCRIPTION OF THE INVENTION
[0069] This invention is not limited in its application to the
details of construction and the arrangement of components set forth
in the following description or illustrated in the drawings. The
invention is capable of other embodiments and of being practiced or
of being carried out in various ways. Also, 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", "containing", "involving" and variations
thereof herein, is meant to encompass the items listed thereafter
as well as, optionally, additional items. In the following
description, the same numerical references refer to similar
elements.
[0070] The present invention is described with respect to replacing
a scaphoid bone of a wrist of a human patient. However, the
invention can apply equally to other bones in other mammalian
patients. For example, the invention can apply to any other bone in
a mammalian wrist, hand, ankle or foot. Therefore, the description
below should not be taken to restrict the scope of the invention to
the replacement of scaphoid bones only.
[0071] In accordance with one embodiment of the present invention,
there is provided an orthopaedic implant 10 (hereinafter referred
to as "implant") for replacing a scaphoid bone of a patient. As
best seen in FIGS. 3A to 3F, the implant 10 is one-piece and
replicates in overall size and shape the scaphoid bone being
replaced based on characterization of the patient's contralateral
scaphoid bone. By virtue of the inventors' surprising discovery
that the left and right scaphoid bones of a human patient are
substantially identical mirror images of each other, the size and
shape of the implant based on the patient's other scaphoid bone is
an anatomical replica or imitation of the scaphoid bone being
replaced.
[0072] The implant 10, as with a scaphoid bone of a human,
comprises a body 12 having a number of articulating surfaces,
specifically a capitate articulating surface 14, a trapezium
articulating surface 15, a radius articulating surface 16 and a
lunate articulating surface 17. By articulating surface it is meant
a surface having at least one contact surface portion on which an
articulating piece such as a bone may articulate such as by
rubbing, sliding or rolling.
[0073] Unlike the scaphoid bone which the implant 10 is replacing,
the implant 10 has at least one attachment element which can be in
the form of an opening or a hole formed on or through its body. In
a preferred embodiment, the attachment element is two openings 18,
20 formed through the implant body 12 for securing the implant 10
to ligaments, tendons or other soft tissue of the wrist or hand of
the patient by sutures or other means. The openings 18, 20 are
positioned so that they do not substantially compromise the
physical properties of the implant 10, such as its strength.
Preferably, the openings are positioning distally and proximally to
one another. Instead of openings, the implant 10 can be provided
with other means of securing the implant to soft tissue such as
protrusions (not shown) or other openings formed on its surface
(not shown). Preferably, the implant 10 is a single piece but can
also be made of a number of pieces, made of the same or different
materials for example, which are formed or joined together.
[0074] The implant 10 can be made of any suitable biocompatible
material such as biocompatible metals, polymers, ceramics and
composites. The implant 10 can be porous or coated. By "suitable
biocompatible material" is meant a biocompatible material which has
adequate physical properties to withstand the biomechanical forces
applied to it once it is implanted into the patient and adequate
wear properties for its intended use. Preferably, the implant 10 is
made of a metal such as a titanium alloy, a cobalt chromium alloy
or a vitallium alloy, according to known biocompatible metal alloy
compositions.
[0075] In an embodiment where the implant is not a single piece
(not shown), the pieces of the implant may be made of different
materials. For example, the body and the attachment element can be
made of different materials. If the attachment element is an
opening or openings, the opening(s) can be partially or fully lined
or covered by a bioactive material to encourage bone or soft tissue
growth for enhanced attachment. Similarly, if the attachment
element is a protrusion, the parts of the protrusion intended for
attachment to the adjacent tissue can be formed of, or covered by,
a material suitable for enhancing or encouraging soft or hard
tissue growth.
[0076] A method 30 of making the implant 10 is summarized in FIG. 4
and includes characterizing the bone which is contralateral to the
one to be replaced, providing a model based on a mirror image of
the characterized contralateral bone. Preferably, the bone being
replaced by the implant 10 is characterized by imaging or any other
non-invasive method. In this embodiment, the bone being replaced by
the implant 10 is the scaphoid bone. By imaging it is meant
characterizing the overall size and shape of the bone which may
include methods other than imaging. Of course, in cases where the
scaphoid bone to be replaced is sufficiently intact, the implant
can be based on the scaphoid bone to be replaced. The implant could
also be used to replace a portion of the scaphoid bone rather than
the entire scaphoid bone. In this way, a customized implant for the
patient can be made. This means that the implant will imitate or
replicate the anatomical shape and size of the bone being
replaced.
[0077] In a preferred embodiment, the patient's scaphoid bone which
is contralateral to the scaphoid bone being replaced by the implant
is characterized using imaging techniques such as Magnetic
Resonance Imaging (MRI), Computed Tomography (CT), positron
emission tomographic (PET) or ultrasound scanning and appropriate
software, such as 3D Doctor.TM. or AutoCAD.TM., to produce
three-dimensional (3D) images of the contralateral bone which can
be processed and converted to a 3D solid implant. Preferably, MRI
is used to capture tomographic image or measurement data of the
bone and three-dimensional image data of the bone is produced based
on this data. Alternatively two-dimensional images of the
contralateral bone can be captured and converted to
three-dimensional images by other means. In another alternative,
the corresponding contralateral bone can be characterized using
techniques other than imaging which are then converted to
three-dimensional images before making the implant. What is
important is that the outer dimensions and shape of the bone to be
replaced are characterized to a reasonable degree of accuracy
before being modeled. The surface topography need not be
characterized to such an extent. Identifying and imaging the larger
surface features may suffice.
[0078] The actual or mirror 3D images of the corresponding
contralateral bone can be processed before making a model or
implant based on them. The processing can include modifying the
surface features or topography to accentuate or smooth the surface
features, for example to reduce facets to approximate a smooth
surface on the implant. The processing can also include forming the
attachment elements, such as the openings through the body of the
imaged bone. The processing is preferably performed digitally but
can also be carried out in other known ways. Alternatively, the
attachment elements, such as the openings 18, 20, can be formed on
the implant 10 itself after the three-dimensional model of the
implant is made from the images, such as by drilling or other known
techniques.
[0079] A preferred method of forming the implant 10 from the images
is using stereolithography using Cobalt Chrome printing.
Alternatively, any other method of making the implant 10 from the
imaged or otherwise characterized bone can be used, such as
moulding or related techniques. The implant can be made
pre-operatively or intra-operatively.
[0080] Advantageously, by virtue of the inventors' discovery that
the scaphoid bones of the left and right hands of humans are
substantially identical mirror images of one another, the undamaged
scaphoid bone of a patient can be used to model a scaphoid implant
to replace the damaged scaphoid bone. By using imaging techniques
such as MRI, CT or any other non-invasive imaging technique, trauma
to the patient is minimized. In this way, an implant which is
anatomically substantially identical or similar to the scaphoid
bone which it is replacing can be produced. Implantation of such a
customized implant in the patient ensures that the biomechanics of
the patient's wrist and hand movement is optimized and wear and
trauma to the wrist and hand is minimized.
[0081] In use, the implant 10 replaces the scaphoid bone when the
scaphoid bone is damaged, such as by disease or fracture. The
scaphoid bone and/or the scaphoid bone fragments are first removed
from the patient before being replaced with the implant 10. The
implant 10 is secured in position by attaching it to some of the
soft tissue structures in the wrist by means of the attachment
element, such as the openings 18, of the implant 10. The inventors
have identified that attachment of the holes 18, 20 of the implant
10 to the SL ligament, the DIC ligament, the capsule and the FCR
provides a balanced and stable positioning of the implant 10 to
avoid dislocation, provide biologic ingrowth and provide an
anatomic replacement of the scaphoid bone. Also, as the scaphoid is
not fixed to the radius, flexibility of movement of the wrist is
obtained. The positions of these soft tissue structures are
identified in FIG. 5B, FIG. 5B and FIG. 5C. FIG. 6 shows the
implant in position.
[0082] A surgical procedure for implantation of the scaphoid
implant involves either a Dorsal or a Volar (Henry's) incision.
Firstly, the scaphoid bone being replaced is exposed taking care to
protect the SL ligament proximally. The DIC is then exposed and
protected distally. The scaphoid bone to be replaced is cut at the
waist and the DIC is sharply dissected from the scaphoid bone
distally. The scaphoid bone is then excised leaving intact the four
soft tissue structures: the dorsal SL ligament with its bony block,
the dorsal DIC ligament, the volar capsule and the volar FCR with
its bony block. The scaphoid implant is then placed into position
and a Bunnel suture in the DIC ligament is passed through the
distal hole of the implant and then sutured to the FCR tendon. A
Bunnel suture in the SL ligament is passed through the proximal
hole of the implant and then sutured to the volar capsule. The
stability of the implant 10, once in place, is checked by flexing
the patient's wrist. The surgical and post-operative techniques
then continue in conventional manner.
[0083] From another aspect, there is provided an orthopaedic
implant 40 (hereinafter referred to as "radius component 40")
(FIGS. 7A and 7B) for resurfacing or replacing a portion of the
distal end of the radius bone and for providing an articulating
surface against which the scaphoid implant 10 can articulate.
Accordingly, the radius component 40 comprises a body 42 attachable
to the radius at the distal end of the radius and an articulating
surface 44. At least a portion of the articulating surface 44 is
shaped and sized to articulate against at least a portion of the
radius articulating surface 16 of the scaphoid implant 10. The body
42 of the radius component 40 has an attachment element, preferably
in the form of openings (holes) 46 formed therethrough for screws,
nails or other fixation devices, to fix the radius component 40 to
the radius bone. Preferably, the radius component 40 replaces only
the portion of the radius surface which would articulate against
the scaphoid implant. In this way, preservation of the radius bone
mass can be maximized.
[0084] The articulating surface 44 of the radius component 40
corresponds substantially in topography or surface features to the
radius articulating surface 16 of the scaphoid implant 10. This
helps to minimize wear and subsequent trauma due to articulation of
the scaphoid implant 10 against the radius component 40.
[0085] The radius component 40 can be made of any suitable
biocompatible material such as biocompatible metals, polymers,
ceramics and composites. Preferably, the radius component 40 is
made of ultra-high molecular weight polyethylene (UHMWPE) which has
suitable wear properties. Alternatively, just the articulating
surface 44 of the radius component 40 can be made of UHMWPE or
other suitable biomaterial.
[0086] In an alternative embodiment, the radius component 40 may be
adapted to replace any other surface which articulates against the
scaphoid implant 10.
[0087] A method 50 of making the radius component 40 is summarized
in FIG. 8. Briefly, the method 50 includes forming a model of the
radius component 40 before making the radius component 40 itself.
The outer dimensions of the model of the radius component are based
on the outer dimensions of a corresponding portion of the patient's
radius (actual or contralateral). The dimensions and
macro-topography of the 3D model of the articulating surface 44 of
the radius component 40 are based on the radius articulating
surface 16 of the scaphoid implant 10.
[0088] The modelling of the outer dimensions of the radius
component 40 is achieved by imaging the radius component which is
to be resurfaced (FIG. 9) to preferably obtain a 3D imaged model 52
of the distal radius (FIG. 10) in the same way as described above
for the scaphoid bone. If the radius component to be resurfaced has
an abnormal morphology or is also diseased or damaged, the
patient's contralateral radius component may be imaged. The
features of the radius articulating surface 16 of the scaphoid
implant 10 are then applied to the 3D imaged model 52 of the distal
radius. In this way, imaging of the radius component can be avoided
which may be inconvenient or problematic due to cartilage of the
radius surface not being visible by CT. Alternatively, the
articulating surface of the radius component 40 may be based on an
image of the radius articulating surface of the radius itself
rather than the implant. It will be appreciated that the either the
scaphoid implant 10 or the radius component 40 may be formed first
with a surface topography based on the actual scaphoid bone or the
radius bone being replaced, or their contralateral counterparts.
What is important is that the surface topography of the
articulating surfaces of the scaphoid implant 10 and the radius
component 40 correspond such that they can matingly engage with one
another in order to minimize wear between these surfaces.
[0089] The 3D imaged model including surface features of the distal
radius can then be processed, if necessary, to smooth and/or reduce
facets (FIGS. 11A and 11B). The processing can include trimming the
model 52 of the outer dimensions of the radius component 40 until
it is the required size and shape (FIGS. 12A to 12G). Preferably,
the imaged model 52 is trimmed to retain only the terminal distal
radius without the styloid. The processing can also include the
addition of attachment elements, such as openings, for receiving
fixation elements 54, such as screws or nails, to the imaged model
52 for fixing the radius component to the radius (FIG. 12H) in
order to determine the positioning of the openings or screw holes.
The resultant imaged model 56 is illustrated in FIG. 12I. The
radius component is then formed from the final imaged model 56
using conventional methods such as stereolithography or molding.
Alternatively, the attachment elements may be formed on the radius
component 40 after the radius component 40 is formed rather than
first modeled on the 3D model 52.
[0090] Advantageously, the articulating surfaces of the scaphoid
implant 10 and the radius component 40 will match which will
minimize wear between them. This will also avoid misalignment which
may affect the other bones of the wrist and lead to bone disease,
such as arthritis, or other damage.
[0091] In use, the radius component 40 is implanted into the distal
portion of the radius bone (FIGS. 13A to 13D). The articulating
surface 44 of the radius component 40 is flush with the intact
adjacent distal surface of the radius. Fixation elements 54 such as
screws and nails hold the radius component 40 in place.
[0092] The distal portion of the radius must be prepared prior to
implantation of the radius component 40 by excising material from
the area in which the radius component 40 is to be implanted.
[0093] Accordingly, according to another aspect of the invention
there is provided a guiding device 60 or jig for assisting in the
preparation, e.g. the cutting, of the distal portion of the radius
prior to implantation of the radius component 40 (FIGS. 14 to 17).
The guiding device 60 comprises a truncated orthogonal-shaped plate
62 which is shaped and sized to be positioned adjacent the distal
end of the radius bone. The plate 62 has an upper edge 64, a lower
edge 66, a scaphoid side edge 68 and a lunate side edge 70. One
corner of the upper edge 64 is truncated (between the scaphoid side
edge 68 and the upper edge 64). From the other corner of the upper
edge 64 (at the lunate side edge) extends an arm 70 with a free end
at substantially right angles to the plate 62. There is a first
slot 72 extending along the arm 70 and having an arm end which
stops short of the free end of the arm 70. The first slot 72 also
extends in the other direction, from the arm 70 to substantially
halfway across the plate 62, between the plate upper and lower
edges 64, 66. There is a substantially circular opening 74 at this
plate end of the first slot 72. There is a second slot 76 extending
from the circular opening towards the scaphoid side edge 68 and
parallel to the upper and lower edges 64, 66. The first and second
slots 72, 76 define cutting guides. There are two openings 78, 80
along the lower edge 66 of the plate 62 one at or near each of the
lower edge corners, for receiving fixing means such as wire, screws
or nails.
[0094] In use, the guiding device 60 is positioned over the distal
end of the bone such that the arm 70 abuts the radius surface at
the distal end of the bone and the plate 62 abuts the adjacent
radius surface. A first k-wire 82, preferably 0.7 mm diameter, or
other fixation device, is inserted through the radius bone parallel
to the ridge between the scaphoid and lunate fossas leaving a free
end protruding from the radius bone (FIG. 18A). The guiding device
60 is positioned adjacent the distal end of the radius with the
guiding device arm 70 being placed over the radius distal end
between the scaphoid fossa and the lunate fossa. The circular
opening 74 at the plate end of the first slot 72 receives the free
end of the first k-wire 82 (FIG. 18B). The guiding device 60 is
further secured in this position using a second and a third k-wire
84, 86, preferably each having a 1 mm diameter, or other fixation
devices, one at each opening 78, 80 at the lower edge corners of
the plate (FIG. 18C). The first k-wire is removed (FIG. 18D) before
cutting the radius along the first and second slots 72, 76,
preferably using a reciprocating device such as a micro-oscillating
saw, to excise the scaphoid fossa (FIG. 18E). The distal radius is
now ready for implantation of the radius component 40.
[0095] The radius component 40 can be positioned on and fixed to
the prepared distal radius in the following way. The radius
component 40 is placed into position on the excised position of the
radius with the scaphoid articulating surface 44 facing outwardly.
A screw, nail 54 or other fixing device, preferably a 2.4 cortical
screw, is inserted percutaneously, radially. Three further screws,
preferably locking screws, are then inserted: 2 volar and 1 dorsal.
The radial cortical screw is then replaced with a further locking
screw (FIG. 18F).
[0096] In practice, the excision or preparation of the distal
radius may be performed before the scaphoid bone is replaced by the
scaphoid implant 10 to take advantage of the space provided by the
excision of the radius bone.
[0097] FIGS. 19 to 22 illustrate a further guiding device 90 which
is for guiding the controlled removal of additional bone, if
required, from the distal radius. This further guiding device 90
will be referred to as a trimming guide device. The trimming guide
device 90 comprises an orthogonal plate 92 having an inner face 94,
an outer face 96, an upper edge 98, a lower edge 100, and two
oppositely facing side edges 102, 104. An arm 106 extends from the
upper edge 98 at substantially right angles from the plate inner
and outer faces 94, 96 so the plate 92 and the arm 106 form an `L`
shape. A slot 108 extends across the plate 92 between its two side
edges 102, 104 near its upper edge 98. The ends of the slot 108 end
short of the side edges 102, 104. Two openings 110, 112 are
provided in the plate 92, one near each side edge and closer to the
lower edge than the slot. The slot 108 defines a cutting guide.
[0098] In use, the trimming guide device 90 is positioned adjacent
the cut portion of the distal radius with the arm 106 overlying the
cut radius portion. The trimming guide device 90 is arranged so
that the height of the slot 108 is aligned with the required cut to
the bone. The device 90 is held in this desired position by placing
k-wires or other fixation devices (not shown) through the plate
openings 110, 112. The k-wires are at the points in the jig in
order to ensure that the trimming guide device 90 does not weaken
the radius by notching. The radius bone is cut along the slot 108
by inserting a cutting edge of a cutting device, such as a
micro-oscillating saw, in the slot 108 which is then guided by the
slot 108.
[0099] FIG. 23 illustrates a correcting device 120 for correcting
the excision of too much bone from the distal radius, for example
in the case of surgeon error. The correcting device allows for the
cutting of a sliver of bone from the excised bone which can then be
grafted onto the radius distal end. The correcting device 120
comprises three components: a tubular portion 122 having a bore 123
running through, an end portion 124 for closing one open end of the
bore 123, and a plunger portion 126 having a plunger 127 which can
be received in the other open end of the bore 123. The end portion
124 and the corresponding open end of the bore 123 are illustrated
in FIGS. 24 and 25. It can be seen that the end portion 124 slides
over runners 128 in the tubular portion 122 to engage with the
tubular portion 122 to close the open end of the bore 123. In use,
the end portion 124 is engaged with the tubular portion 122 to
close the open bore end. The excised bone piece removed from the
distal radius is inserted into the bore 123 of the tubular portion
122, flat side down, from the other open end. The plunger 127 is
placed into the open end of the bore 123 and pressed downwardly to
engage with the bone piece and hold the bone piece in place to
enable slivers of bone to be cut from the bone piece. Once cut, the
bone sliver is retrieved by removing the end portion from the
tubular portion 122. Accordingly, a slot 128 is provided through a
wall of the tubular portion corresponding to the position of the
bone sliver when in position in the tubular portion (FIG. 25). The
slot can receive a blade or a cutting edge of a cutting device. The
cutting device can be any device suitable for cutting bone such as
a reciprocating device e.g. an oscillating saw. The correcting
device 120 is provided with different sizes/depths to enable the
cutting of different thicknesses of bone slivers from the excised
bone piece. The bone slivers will then be placed back onto the cut
surface of the distal radius.
[0100] The guiding device 60, trimming guide device 90 and the
correcting device 120 can be made from any suitable material in
conventional manner. Preferably, they are made from metal. They may
be provided in kit form either individually or altogether.
[0101] It should be appreciated that the invention is not limited
to the particular embodiments described and illustrated but
includes all modifications and variations falling within the scope
of the invention as defined in the appended claims. For example,
instead of screws, nails, k-wires or other wires used for securing,
other fixation devices can equally be used. The aspects of the
present invention can be applied to bones other than the scaphoid
bone as will be clear to a person skilled in the art, e.g. the
talus, calcaneus, navicular, and cuneiforms bones as well as all
small bones of the hand and foot.
EXAMPLES
[0102] The following examples are illustrative of the applicability
of the present invention and are not intended to limit its scope.
Modifications and variations can be made therein without departing
from the spirit and scope of the invention. Although any method and
material similar or equivalent to those described herein can be
used in the practice for testing of the present invention, the
preferred methods and materials are described.
Example 1
[0103] The scaphoid implant 10 of the present invention was made
and implanted in the manner as described above into the wrist of a
cadaver, including use of the cutting guide jigs. FIGS. 26A and
26B, 27A and 27B, and 28A and 28B show x-rays taken of the
cadaver's wrist after implantation and during maximum flexion and
extension.
Example 2
[0104] The inventors performed a cadaveric study using MRI and CT
on the symmetry of contralateral scaphoid bones. Surprisingly, they
found that the contralateral scaphoid bones are mirror images of
one another, as determined by four geometrical features: 1) long
axis, 2) waist length, 3) distal pole and 4) proximal pole (FIG.
29A).
[0105] A CT and MR investigation of 12 pairs of cadaveric wrists
was made in neutral position. After imaging, each wrist was
dissected and the bones were cleaned of any connective tissue. The
bones were measured along their longest axis and the volume of each
bone was determined by water displacement measurements.
Lunate Measurements
[0106] Antero-dorsal diameter (16.96 mm.+-.1.6) [0107]
Medio-lateral diameter (12.8 mm.+-.1.37) [0108] Height/max length
[0109] Volume [0110] Surface Area.
Scaphoid Measurements
[0110] [0111] Height/Max length [0112] Volume [0113] Surface
Area.
[0114] A statistical analysis was carried using the Pearson
correlation coefficient comparing CT/MRI and anatomical
measurements of the right and left bones.
* * * * *