U.S. patent application number 17/655241 was filed with the patent office on 2022-07-07 for screw fixation method.
The applicant listed for this patent is AZURMEDS INC.. Invention is credited to Jean-Marie BERGER, Christopher R. CHUINARD, Pierric DERANSART, Thomas Bradley EDWARDS, Grant E. GARRIGUES, Armodios M. HATZIDAKIS, Gregory P. NICHOLSON, Felix Buddy SAVOIE.
Application Number | 20220211421 17/655241 |
Document ID | / |
Family ID | 1000006213385 |
Filed Date | 2022-07-07 |
United States Patent
Application |
20220211421 |
Kind Code |
A1 |
BERGER; Jean-Marie ; et
al. |
July 7, 2022 |
SCREW FIXATION METHOD
Abstract
A method for fixing a bone graft on a shoulder bone includes,
before selection and use of a fixation device, a preoperative plan
including collecting a preoperative imaging of a shoulder of a
patient; virtually 3D modeling the shoulder; identifying at least
one anatomical structure; and preoperative planning by one of
sizing the graft, positioning the graft on the host bone,
positioning the fixation device, and/or selecting the fixation
device.
Inventors: |
BERGER; Jean-Marie; (Eden
Prairie, MN) ; DERANSART; Pierric; (Saint martin
d'Uriage, FR) ; CHUINARD; Christopher R.; (Traverse
City, MI) ; EDWARDS; Thomas Bradley; (Houston,
TX) ; GARRIGUES; Grant E.; (Hinsdale, IL) ;
HATZIDAKIS; Armodios M.; (Denver, CO) ; NICHOLSON;
Gregory P.; (Western Spring, IL) ; SAVOIE; Felix
Buddy; (New Orleans, LA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
AZURMEDS INC. |
Dallas |
TX |
US |
|
|
Family ID: |
1000006213385 |
Appl. No.: |
17/655241 |
Filed: |
March 17, 2022 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
16724886 |
Dec 23, 2019 |
11291487 |
|
|
17655241 |
|
|
|
|
62783780 |
Dec 21, 2018 |
|
|
|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 2017/567 20130101;
A61B 17/863 20130101; A61B 2017/681 20130101; A61B 17/8866
20130101; A61B 2017/564 20130101; A61B 2017/568 20130101; A61B
17/8605 20130101; A61B 17/1635 20130101; A61F 2/40 20130101; A61B
17/1684 20130101; A61F 2002/4627 20130101; A61F 2002/2835 20130101;
A61B 17/864 20130101; A61B 34/10 20160201; A61F 2/30749 20130101;
A61B 17/68 20130101; A61B 17/8635 20130101; A61B 2034/105 20160201;
A61B 17/1778 20161101 |
International
Class: |
A61B 17/86 20060101
A61B017/86; A61B 17/17 20060101 A61B017/17; A61B 17/16 20060101
A61B017/16; A61B 17/68 20060101 A61B017/68; A61B 17/88 20060101
A61B017/88; A61B 34/10 20060101 A61B034/10; A61F 2/30 20060101
A61F002/30; A61F 2/40 20060101 A61F002/40 |
Claims
1. A method for fixing a bone graft on a shoulder bone, the method
comprising, before selection and use of a fixation device, a
preoperative plan including the following operations: collecting a
preoperative imaging of a shoulder of a patient by radiography
and/or ultrasound and/or CT image and/or MRI of the shoulder;
virtually 3D modeling the shoulder; identifying at least one
anatomical structure; and preoperative planning of at least one of
the following operations: sizing the graft, positioning the graft
on the host bone, positioning the fixation device, and selecting
the fixation device.
2. The fixation method according to claim 1, wherein the method
further comprises the following operations: displaying during
surgical intervention the preoperative plan on an augmented or
mixed reality device.
3. The fixation method according to claim 2, wherein the operations
of displaying during the surgical intervention the preoperative
plan on an augmented or mixed reality device comprises overlaying
the preoperative plan onto a corresponding patient bone.
4. The fixation method according to claim 2, wherein the operations
of displaying during the surgical intervention the preoperative
plan on an augmented or mixed reality device comprises overlaying
the preoperative plan onto a corresponding patient bone and guiding
at least one of the following operations: sizing the graft,
positioning the graft on the host bone, positioning the fixation
device and selecting the fixation device.
5. The fixation method according to claim 1, wherein the fixation
device is comprised of two screws and only two screws.
6. The fixation method according to claim 5, wherein at least one
of the two screws comprises a cannula, where the at least one of
the two screws is provided with a longitudinal through hole.
7. The fixation method according to claim 1, wherein the fixation
device is comprised of two screws and only two screws, comprising:
a first screw provided at a proximal end with a head for
compressing a bone by an end-abutment; and a second screw provided
at a distal end with a bone threading having a first helix pitch
and at a proximal end with a bone threading having a helix with a
pitch smaller than the first helix pitch, the second screw being
headless.
8. The fixation method according to claim 7, wherein the method
further comprises, after the preoperative planning step, using the
first and second screws to position the bone graft on the host bone
and fix the bone graft on the shoulder.
9. The fixation method according to claim 1, wherein the method
further comprises, after the preoperative planning step, using the
fixation device to position the bone graft on the host bone and fix
the bone graft on the shoulder.
10. The fixation method according to claim 9, wherein the method
further comprises the following operations: displaying during
surgical intervention the preoperative plan on an augmented or
mixed reality device.
11. The fixation method according to claim 10, wherein the
operations of displaying during the surgical intervention the
preoperative plan on an augmented or mixed reality device comprises
overlaying the preoperative plan onto a corresponding patient
bone.
12. The fixation method according to claim 10, wherein the
operations of displaying during the surgical intervention the
preoperative plan on an augmented or mixed reality device comprises
overlaying the preoperative plan onto a corresponding patient bone
and guiding at least one of the following operations: sizing the
graft, positioning the graft on the host bone, positioning the
fixation device and selecting the fixation device.
13. The fixation method according to claim 9, wherein the fixation
device is comprised of two screws and only two screws.
14. The fixation method according to claim 13, wherein at least one
of the two screws comprises a cannula, where the at least one of
the two screws is provided with a longitudinal through hole.
15. The fixation method according to claim 9, wherein the fixation
device is comprised of two screws and only two screws, comprising:
a first screw provided at a proximal end with a head for
compressing a bone by an end-abutment; and a second screw provided
at a distal end with a bone threading having a first helix pitch
and at a proximal end with a bone threading having a helix with a
pitch smaller than the first helix pitch, the second screw being
headless.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 16/724,886 filed Dec. 23, 2019, which claims priority from
Provisional Application No. 62/783,780 filed Dec. 21, 2018. Each of
the previously noted applications is hereby incorporated by
reference herein in their entirety.
FIELD OF APPLICATION OF THE INVENTION
[0002] The invention relates to the fixation by screws in bones and
in particular to the adaptations allowing to optimize this
fixation.
DESCRIPTION OF THE PRIOR ART
[0003] There is a plurality of situations where screws are
introduced for purposes of fixation of one portion of bone to
another portion of bone. For example, as part of an abutment
procedure for the treatment of shoulder instabilities, there is a
fixation device composed of two screws ensuring the fixation of a
bone graft (from the cutting of the coracoid, operation called
Latarjet operation, or other sample--outer quarter of the clavicle,
iliac crest- or -distal tibia-allograft or formed by a block of
bone substitute) forming an abutment on the injured edge of the
glenoid surface of the scapula.
[0004] Among the screws proposed for this type of fixation, there
are headless screws and head screws. To differentiate them, a head
screw is considered to be pre-formed with a protruding proximal
portion, relative to the shaft, which is smooth blocking the
advancement of the screw in the bone whereas a headless screw does
not have this smooth blocking protruding portion. The rear portion
of the screw located at one end of the screw and pre-formed with a
means for cooperation with the setting tool is called proximal
portion. The distal portion is the front portion of the screw
located at the other end and coming into contact first with the
part to be fixed.
[0005] These screws are conventionally used for this type of
application by pair of screws with the same features.
[0006] Among the headless screws, there are those described in
documents U.S. Pat. Nos. 4,175,555, 4,463,753, 5,403,136, 6,306,140
and 10,130,407.
[0007] The fixation device comprising such screws has several
disadvantages, among these disadvantages: [0008] The complexity of
the revision (that is to say of removing the fixation) due to the
difficulty of identifying the proximal portion of the screw and the
difficulty of inserting the setting tool in the cooperation means
(burial of the cooperation means in the bone); [0009] To obtain
adequate compression, there is a risk of incorrect positioning of
the screw (protrusion of the screw forward of the graft or rearward
of the scapula), with consequently: [0010] Risk of injuring
anatomical structures (muscle, nerve); [0011] Risk of loss of the
graft fixation if one of the screws passes through the graft;
[0012] To obtain an adequate positioning of the screw, a risk of
insufficient or excessive compression (because it depends on the
bone quality and the driving of the screw) with consequently:
[0013] Risk of loss of the graft fixation and mobilization of the
graft in case of insufficient compression; [0014] Risk of graft
fracture in the event of over-compression.
[0015] Among the head screws, there are those described in the
following documents: U.S. Pat. Nos. 4,537,185, 5,334,204,
5,925,048, 6,565,573, 7,637,929 and 8,900,279.
[0016] The device comprising such screws has disadvantages, among
these disadvantages: [0017] With heads that are partially or
totally buried in the graft (hemispherical head): [0018] A risk of
graft fracture (too small bone section between the two screw heads
or too small bone section between the screw head and the end of the
graft); [0019] The complexity of the revision due to the difficulty
of identifying the screw head and the difficulty of inserting the
setting tool in the cooperation means (burial of the cooperation
means in the bone). [0020] With heads that are partially or totally
protruding from the graft (flat or domed head): [0021] A risk of
irritation of the soft tissues (muscles, ligaments, nerves, etc.)
by friction on the screw head. [0022] A risk of conflict between
the two screw heads (indeed the diameter of the screw heads
dictates the center distance which can prove to be too large
relative to the size of the bone graft, especially in the case of a
small graft) with consequently: [0023] Risk of graft fracture (too
small bone section between the head of the second screw and the end
of the graft); [0024] Risk of insufficient compression at the
second screw (overlapping of the screw heads); [0025] Risk of
malpositioning the first screw (during compression of the second
screw, displacement of the first screw which can generate a loss of
the screw fixation and/or a damage to the graft);
BRIEF DESCRIPTION OF THE INVENTION
[0026] Noticing this, the applicant has conducted research aiming
at proposing an alternative fixation device solving the
disadvantages of the prior art.
[0027] These research resulted in the design of a bone screw
fixation device comprising two screws and only two, remarkable in
that it comprises: [0028] A first screw provided at its proximal
end with a head for compressing the bone by an end-abutment; [0029]
A second screw provided at its distal end with a bone threading
having a first helix pitch and at its proximal end with a bone
threading having a helix with a pitch smaller than the first helix
pitch.
[0030] The difference in pitch between the distal and proximal
threadings of the second screw allows having the desired
compression.
[0031] This device is intended for fixing without a plate a bone
graft in the shoulder for the purposes of treating pathologies
related to the shoulder instability.
[0032] This device is more particularly intended for fixing the
bone graft in the context of a Lartajet procedure.
[0033] This feature is particularly advantageous in that the
combined use of a head screw and a headless screw guarantees:
[0034] The optimal position of the two screws independent of the
size and the shape of the graft; [0035] An optimal compression of
the graft obtained by the bearing of the head screw on the graft
and by the difference in pitch between the distal thread and the
proximal thread of the headless screw; [0036] The absence of risk
of conflict between the two proximal portions of the screws, one
being buried in the graft and the other being protruding from the
graft; [0037] A control of the risk of graft fracture since the
first compression is given by the head screw. The risk of exerting
an excessive compression with the headless screw is therefore
reduced.
[0038] The head screw is generally placed first, in particular for
the reasons mentioned above. In addition, it is generally the screw
located in the lowest position that is installed first.
[0039] According to another particularly advantageous feature of
the invention, at least one of the screws comprises a cannula, that
is to say that the screw is provided with a longitudinal through
hole,
[0040] According to another particularly advantageous feature of
the invention, the head screw comprises: [0041] a distal threaded
portion (at a distance from the head) threaded according to a first
pitch, [0042] a proximal threaded portion (close to the head)
threaded according to a second pitch smaller than the first
pitch.
[0043] According to another particularly advantageous feature, at
least one of the screws comprises a conical proximal threaded
portion.
[0044] According to another particularly advantageous feature, the
two screws comprise a conical proximal threaded portion.
[0045] According to another particularly advantageous feature of
the invention, the conicity of the proximal portion of the two
screws has a half angle of about 10 degrees.
[0046] According to another particularly advantageous feature of
the invention, the proximal portion of at least one screw includes
a smooth portion.
[0047] According to another particularly advantageous feature of
the invention, the smooth portion is pre-formed on the head screw
between the head and the threaded proximal portion and has a
diameter less than the largest diameter of the threaded proximal
portion.
[0048] According to another particularly advantageous feature of
the invention, the device comprises the two following screws:
[0049] A first head screw
[0050] including
[0051] a cannula, that is to say that the screw is provided with a
longitudinal through hole of a diameter comprised between 1 and 2
millimeters,
[0052] a head of a diameter comprised between 6 and 9 millimeters
and a thickness at the center comprised between 1 and 3
millimeters,
[0053] a distal threaded portion (at a distance from the head)
threaded according to a first pitch and of an outer diameter
comprised between 3 and 5 millimeters;
[0054] a conical proximal threaded portion (close to the head)
threaded according to a second pitch smaller than the first pitch;
[0055] a second headless screw
[0056] including
[0057] a distal threaded portion threaded according to a first
pitch and of an outer diameter comprised between 3 and 5
millimeters,
[0058] a conical proximal threaded portion threaded according to a
second pitch smaller than the first pitch.
[0059] According to a preferred but non-limiting embodiment, the
threadings of the distal portions of the screws are multiple
threadings and the threadings of the proximal portions are single
threadings.
[0060] According to another particularly advantageous feature of
the invention, the two screws have a smooth middle portion
separating the proximal portion from the distal portion.
[0061] According to another particularly advantageous feature of
the invention, the length of the distal threaded portion forms
between 46 and 56 percent of the total length of the head screw and
forms between 48 and 58 percent of the total length of the headless
screw.
[0062] This proportion is defined so that the distal threaded
portion is engaged only and solely in the host bone and in no case
in the graft, this to allow the compression.
[0063] According to another particularly advantageous feature of
the invention, the length of the proximal threaded portion of the
two screws has a length of 5 to 10 millimeters.
[0064] This length is defined so that the proximal threaded portion
is engaged only and solely in the graft and in no case in the host
bone, this to allow the compression.
[0065] The invention also relates to a fixation kit formed of the
device described above, namely that the two screws of different
designs are packaged in a same package. Thus, according to another
particularly advantageous feature, the device is remarkable in that
it comprises two screws of different designs which are packaged in
a same package for purposes of creating a ready-to-use fixation
kit.
[0066] According to a particularly advantageous embodiment of the
invention, the kit consists of two screws with a length difference
comprised between 0.5 and 5.5 millimeters.
[0067] According to one embodiment, the kits are delivered
non-sterile in a packaging adapted to the sterilization by the care
facility.
[0068] According to another embodiment, the kits are delivered
sterile in a packaging adapted to the sterilization by gamma ray or
x-ray and adapted to an aseptic transfer of the device.
[0069] According to another particularly advantageous feature, the
fixation kit contains screws which have been selected and/or sized
specifically for one patient according to a preoperative planning
established based on the preoperative imaging of the patient.
[0070] The invention also relates to a bone screw provided at its
proximal end with a head for compressing the bone by an
end-abutment, at its distal end with a bone threading according to
a first pitch, remarkable in that it comprises under the head a
proximal smooth portion and that it comprises under the proximal
smooth portion a proximal threaded portion threaded according to a
second pitch smaller than the first pitch.
[0071] According to another feature, the proximal threaded portion
of said screw is conical.
[0072] According to another feature, the distal threaded portion of
said screw includes a multiple thread.
[0073] According to another feature the proximal smooth portion of
said screw has a diameter less than the largest diameter of the
proximal threaded portion.
[0074] The invention also relates to a method for fixing a bone
graft on a shoulder bone remarkable in that it uses two screws and
only two adopting the features described above taken together or
separately.
[0075] Thus, this method applies to a fixation procedure called
"Latarjet" procedure.
[0076] According to another particularly advantageous feature, the
method comprises before the selection and the use of the screws, a
preoperative planning including the following operations: [0077]
Collection of a preoperative imaging of the shoulder of the patient
by radiography and/or ultrasound and/or CT image and/or MRI of the
shoulder, [0078] Modeling of the joint, [0079] Identification of at
least one anatomical structure, [0080] Preoperative planning of at
least one of the following elements: sizing the graft, positioning
the graft, positioning the screws,
[0081] According to another particularly advantageous feature, the
preoperative planning method includes, between the identification
and planning operation, an operation of measuring at least one
specific feature of the joint of the patient.
[0082] The fundamental concepts of the invention having just been
exposed above in their most elementary form, other details and
features will emerge more clearly upon reading the description that
follows and with reference to the appended drawings, giving by way
of a non-limiting example, an embodiment of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0083] FIG. 1 is an external side view of an embodiment of a first
one of the two screws of the device of the invention;
[0084] FIG. 2 is a sectional side view of the screw of FIG. 1;
[0085] FIG. 3 is an external side view of an embodiment of the
second one of the two screws of the device of the invention;
[0086] FIG. 4 is a sectional side view of the screw of FIG. 3;
[0087] FIG. 5 is a sectional view of an assembly of a bone graft to
another bone.
[0088] FIG. 6 is a diagram of the main phases of the process
leading to the selection and/or the creation of a kit and/or screws
according to the invention specific to a patient.
DESCRIPTION OF A PREFERRED EMBODIMENT
[0089] An embodiment of the device of the invention consists of the
two illustrated screws.
[0090] The first screw 100 of FIGS. 1 and 2 comprises a head 110
and a rod 120. The head 110 comprises a recess 111 to cooperate
with a setting tool (not illustrated) allowing the insertion of the
screw into the bone. This first screw is pre-formed by a cannula
130.
[0091] The rod 120 is divided into several portions: [0092] A
smooth proximal portion 121 disposed under the head 110, [0093] A
conical proximal threaded portion 122 having a given pitch (single
thread and disposed under the smooth proximal portion 121), [0094]
A smooth middle portion 123, [0095] A distal threaded portion 124
having a pitch larger (double thread) than the pitch of the
proximal portion 122.
[0096] The second screw 200 of FIGS. 3 and 4 is formed of a solid
headless body which comprises [0097] A conical proximal threaded
portion 210 having a given pitch (single thread) and a recess 211
to cooperate with a setting tool, [0098] A smooth middle portion
220, [0099] A distal threaded portion 230 having a pitch larger
(double thread) than the pitch of the proximal portion 210.
[0100] As illustrated in the drawing of FIG. 5, the device is used
for fixing the bone graft G to a host bone O. As illustrated, the
screws are sized so that: [0101] the proximal threaded portions 122
and 210 cooperate only with the graft G; [0102] the distal threaded
portions 124 and 230 cooperate only with the host bone O.
[0103] In addition, the length of the screws 100 and 200 is defined
so that the distal threaded portions 124 and 230 of the screws pass
through the cortical wall, of the host bone O, opposite the bone
graft G.
[0104] Prior to the surgical intervention, during the phase of
collecting data 310, the preoperative imaging of the patient to be
operated is acquired in various ways. For example, radiographies
and/or ultrasounds and/or CT images and/or MRI of the shoulder are
used.
[0105] Based on the preoperative imaging of the patient to be
operated, during a modeling and identification phase 320, at least
one segmentation and treatment algorithm allows modeling the joint
of the patient, identifying at least one anatomical structure. This
phase may include the measurement of at least one specific feature
of the joint of the patient.
[0106] During the planning phase 330, the surgeon performs a
preoperative planning by means of a computer interface allowing to
view the modeling of the joint and to perform at least one of the
following operations: sizing the graft, positioning the graft on
the host bone and positioning and selecting the screws constituting
the fixation device according to the invention.
[0107] This method may further include the constitution,
manufacture and provision for the surgical intervention of a
patient-specific fixation kit produced based on the previously
collected data and, particularly, on the planning output data.
[0108] It is understood that the device which has just been
described and represented above, has been for the purpose of
disclosure rather than limitation. Of course, various arrangements,
modifications and improvements can be made to the example above,
without departing from the scope of the invention.
* * * * *