U.S. patent application number 15/621313 was filed with the patent office on 2017-09-28 for expandable tissue spacer implant and method of use.
This patent application is currently assigned to MEDIVEST, LLC. The applicant listed for this patent is MEDIVEST, LLC. Invention is credited to Brian G. EMERICK, Jeffrey A. FARRIS, Heidi STAMETS, Brent WALTER.
Application Number | 20170273804 15/621313 |
Document ID | / |
Family ID | 49712646 |
Filed Date | 2017-09-28 |
United States Patent
Application |
20170273804 |
Kind Code |
A1 |
EMERICK; Brian G. ; et
al. |
September 28, 2017 |
EXPANDABLE TISSUE SPACER IMPLANT AND METHOD OF USE
Abstract
A horizontal and vertical expandable tissue spacer implants,
insertion tools, assembly methods and surgical methods are
disclosed. The horizontal expandable tissue spacer implant includes
a first lateral member with a first side, a second lateral member
with a first side, and an intermediate spacer member. The
intermediate spacer member is adapted to cooperatively engage and
hold the first side of the first lateral member and the first side
of the second lateral member. A vertical expandable tissue spacer
implant includes a top member with a bottom surface, a bottom
member with a top surface, and an intermediate spacer member with a
coupling mechanism. The coupling mechanism cooperatively engages
the bottom surface of the top member to the intermediate spacer
member and the top surface of the bottom member to the intermediate
spacer member.
Inventors: |
EMERICK; Brian G.; (Columbia
City, IN) ; FARRIS; Jeffrey A.; (Berne, IN) ;
WALTER; Brent; (Huntington, IN) ; STAMETS; Heidi;
(Monroeville, IN) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
MEDIVEST, LLC |
Columbia City |
IN |
US |
|
|
Assignee: |
MEDIVEST, LLC
Columbia City
IN
|
Family ID: |
49712646 |
Appl. No.: |
15/621313 |
Filed: |
June 13, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
14406013 |
Dec 5, 2014 |
9693877 |
|
|
PCT/US2013/044563 |
Jun 6, 2013 |
|
|
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15621313 |
|
|
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|
61656283 |
Jun 6, 2012 |
|
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|
Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F 2002/30398
20130101; A61F 2002/30593 20130101; A61F 2002/30387 20130101; A61F
2002/4629 20130101; A61F 2/4684 20130101; A61F 2310/00023 20130101;
A61F 2/4611 20130101; A61F 2002/3084 20130101; A61F 2002/30892
20130101; A61F 2/4465 20130101; A61F 2002/30481 20130101; A61F
2002/30616 20130101; A61F 2002/2835 20130101; A61F 2002/30579
20130101; A61F 2002/30507 20130101; A61F 2310/00011 20130101; A61F
2002/30011 20130101; Y10T 29/49947 20150115; A61F 2002/4661
20130101; A61F 2002/30505 20130101; A61F 2002/305 20130101; A61F
2002/30828 20130101; A61F 2/3094 20130101; A61F 2310/00017
20130101; A61F 2/447 20130101; A61F 2002/30607 20130101; A61F
2002/4628 20130101 |
International
Class: |
A61F 2/44 20060101
A61F002/44; A61F 2/46 20060101 A61F002/46 |
Claims
1. A horizontal expandable tissue spacer implant, the implant
comprising: a first lateral member with a first side; a second
lateral member with a first side; an intermediate spacer member
being adapted to cooperatively engage and hold the first side of
the first lateral member and the first side of the second lateral
member, wherein the intermediate spacer member includes an inner
cavity defined by a top side opposite a bottom side and a front
side opposite a rear side, wherein the rear side includes a tapered
opening extending across the entire rear side; and a spacer insert
for insertion into the inner cavity of the intermediate spacer
member, wherein the spacer insert engages at least a portion of the
front side of the inner cavity and at least a portion of the rear
side of the inner cavity.
2. The implant of claim 1, wherein the intermediate spacer member,
the first lateral member, and the second lateral member each have a
generally rectangular outside perimeter.
3. The implant of claim 2, wherein the spacer insert has a
generally rectangular outside perimeter.
4. The implant of claim 3, further comprising: a threaded rod for
engaging the intermediate spacer member and the spacer insert to
activate a coupling mechanism.
5. The implant of claim 1, further comprising: a coupling
mechanism, wherein the coupling mechanism, comprises: two pairs of
projections on the intermediate spacer member; a pair of
projections on the first side of the first lateral member; and a
pair of projections on the first side of the second lateral
member.
6. The implant of claim 5, wherein the two pairs of projections
include a first pair of projections on a first side of the
intermediate spacer member and a second pair of projections on a
second side of the intermediate spacer member.
7. The implant of claim 6, wherein the first pair of projections of
the intermediate spacer member engages the corresponding pair of
projections on the first side of the first lateral member and the
second pair of projections of the intermediate spacer member
engages the corresponding pair of projections on the first side of
the second lateral member.
8. The implant of claim 1, wherein the spacer insert comprises: a
first end with an opening configured to engage the threaded rod;
and a second end configured with at least two angled portions for
contacting the tapered opening of the intermediate spacer member,
wherein the second end of the spacer insert extends into the
tapered opening of the intermediate spacer member.
9. The implant of claim 7, wherein the two pairs of projections of
the intermediate spacer member, the pair of projections on the
first side of the first lateral member, and the pair of projections
on the second lateral member comprise dovetails.
10. An expandable tissue spacer implant, the implant comprising: a
top member with a bottom surface; a bottom member with a top
surface; a lateral member with a first side; and an intermediate
spacer member having coupling members, wherein the coupling members
cooperatively engage the bottom surface of the top member to the
intermediate spacer member, the top surface of the bottom member to
the intermediate spacer member, and the first side of the lateral
member to the intermediate spacer member.
11. The implant of claim 10, wherein the coupling members,
comprises: two pairs of projections disposed on the intermediate
spacer member; a pair of projections disposed on the bottom surface
of the top member; a pair of projections disposed on the top
surface of the bottom member; and a pair of projections disposed on
the first side of the lateral member.
12. The implant of claim 11, wherein the two pairs of projections
include a first pair of projections on a top side of the
intermediate spacer member and a second pair of projections on a
bottom side of the intermediate spacer member.
13. The implant of claim 12, wherein the first pair of projections
of the intermediate spacer member engage at least a portion of the
pair of projections on the bottom surface of the top member and the
second pair of projections of the intermediate spacer member engage
at least a portion of the pair of projections on the top surface of
the bottom member.
14. The implant of claim 13, wherein the pair of projections of the
lateral member engage at least a portion of one of the projections
on the bottom surface of the top member and at least a portion of
one of the projections on the top surface of the bottom member.
15. The implant of claim 13, wherein the intermediate spacer member
further comprises a passageway on a front wall and the lateral
member further comprises an opening on a front wall.
16. The implant of claim 15, further comprising: a locking
mechanism with a head portion for engaging the front wall of the
lateral member and an extension portion for insertion into the
passageway of the intermediate spacer member.
17. The implant of claim 16, wherein the locking mechanism further
comprises two legs each with a protrusion for engaging the top
member and the bottom member.
18. The implant of claim 10, wherein the lateral member further
comprises an engagement member extending from the inner side and
forming a front wall of the lateral member, wherein an interior
surface of the engagement member engages a portion of the front
wall of the intermediate spacer member.
19. The implant of claim 11, wherein the projections comprise
dovetails.
20. A surgical method for maintaining a space between two tissue
bodies in a living being, comprising: obtaining a medical device
comprising: a first member; a second member; and an intermediate
spacer member having a coupling mechanism, wherein the coupling
mechanism slidingly couples the first member to the intermediate
spacer member and the second member to the intermediate spacer
member; coupling the first and second members to an insertion
instrument; positioning and inserting the insertion instrument with
the coupled first and second members into a space between the two
tissue bodies to maintain or increase the space therebetween;
slidingly inserting the intermediate spacer member within the
insertion instrument and into the space between the first and
second members; and securing the intermediate spacer member to the
two first and second members.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application is a continuation of U.S. application Ser.
No. 14/406,013 filed Dec. 5, 2014, which is a national stage
application based on International Application PCT/US2013/044563
filed on Jun. 6, 2013, published as WO 2013/184649 on Dec. 12,
2013, which claims priority benefit under 35 U.S.C. .sctn.119(e) of
U.S. provisional application No. 61/656,283 filed Jun. 6, 2012,
which are incorporated herein by reference in their entireties.
TECHNICAL FIELD
[0002] The present invention relates generally to general surgery,
orthopaedic and neurosurgical implants used for insertion within a
space between hard and soft tissue structures, and more
specifically, but not exclusively, concerns devices implanted
within a bone to replace a resected, fractured or diseased portion
and to maintain or reestablish proper spacing between the bone
fragments.
BACKGROUND OF THE INVENTION
[0003] Damage or disease that affects the integral structure of a
bone or other structures, may lead to neurologic impairment or loss
of structural support integrity with possible permanent damage to
the surrounding soft tissue and adjacent neurologic, vascular and
systemic structures. Maintaining or reestablishing anatomic spacing
within a bone structure or other structural tissue is critical to
ensuring continued functionality and mobility of the patient and
avoidance of long-term serious neurological, vascular or other
systemic impairments. Please note that the terms "implant" and
"device" may be used interchangeably and have the same meaning
herein.
SUMMARY OF THE INVENTION
[0004] The present invention provides in one aspect, a horizontal
expandable tissue spacer implant that includes a first lateral
member with a first side, a second lateral member with a first
side, and an intermediate spacer member. The intermediate spacer
member is adapted to cooperatively engage and hold the first side
of the first lateral member and the first side of the second
lateral member.
[0005] The present invention provides in another aspect, a vertical
expandable tissue spacer implant that includes a top member with a
bottom surface, a bottom member with a top surface, and an
intermediate spacer member with a coupling mechanism. The coupling
mechanism cooperatively engages the bottom surface of the top
member to the intermediate spacer member and the top surface of the
bottom member to the intermediate spacer member.
[0006] The present invention provides in a further aspect, a method
of assembling an implant, including obtaining an intermediate
spacer member having a coupling mechanism, selecting a first member
with a first pair of projections and selecting a second member with
a second pair of projections. The method may also include engaging
the first pair of projections of the first member to the coupling
mechanism of the intermediate spacer member and engaging the second
pair of projections of the second member to the coupling mechanism
of the intermediate spacer member and inserting a locking mechanism
into the intermediate spacer member to actuate the coupling
mechanism and secure the first member and second member to the
intermediate spacer member.
[0007] The present invention provides in yet another aspect, a
surgical method for maintaining a space between two tissue bodies
in a living being, including obtaining a medical device with a
first member, a second member, and an intermediate spacer member.
The intermediate spacer member includes a coupling mechanism which
slidingly couples the first member to the intermediate spacer
member and the second member to the intermediate spacer member. The
method may also include coupling the first and second members to a
distraction or insertion instrument and positioning and inserting
the distraction instrument with the coupled first and second
members into a space between the two tissue bodies to maintain or
increase the space therebetween. Further, the method may also
include slidingly inserting the intermediate spacer member within
the insertion instrument and into the space between the first and
second members and securing the intermediate spacer member to the
two first and second members.
[0008] Further, additional features and advantages are realized
through the techniques of the present invention. Other embodiments
and aspects of the invention are described in detail herein and are
considered a part of the claimed invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] The subject matter which is regarded as the invention is
particularly pointed out and distinctly claimed in the claims at
the conclusion of the specification. The foregoing and other
objects, features and advantages of the invention are apparent from
the following detailed description taken in conjunction with the
accompanying drawings in which:
[0010] FIG. 1 is a front, elevational view of one embodiment of a
horizontal expandable tissue spacer device, in accordance with an
aspect of the present invention;
[0011] FIG. 2 is an exploded front, elevational view of the tissue
spacer device of FIG. 1, in accordance with an aspect of the
present invention;
[0012] FIG. 3 is a side, elevational view of the insert for the
tissue spacer device of FIG. 1, in accordance with an aspect of the
present invention;
[0013] FIG. 4 is a front, perspective view of the insert for the
tissue spacer device of FIG. 1, in accordance with an aspect of the
present invention;
[0014] FIG. 5 is a front, perspective view of an intermediate
spacer member with the insert in position for the tissue spacer
device of FIG. 1, in accordance with an aspect of the present
invention;
[0015] FIG. 6 is a front, perspective view of an intermediate
spacer member without the insert in position for the tissue spacer
device of FIG. 1, in accordance with an aspect of the present
invention;
[0016] FIG. 7 is a rear, perspective view of the intermediate
spacer member without the insert in position for the tissue spacer
device of FIG. 1, in accordance with an aspect of the present
invention;
[0017] FIG. 8 is a side, elevational view of the intermediate
spacer member without the insert in position for the tissue spacer
device of FIG. 1, in accordance with an aspect of the present
invention;
[0018] FIG. 9 is a top view of the intermediate spacer member for
the tissue spacer device of FIG. 1, in accordance with an aspect of
the present invention;
[0019] FIG. 10 is a medial side, perspective view of one embodiment
of a lateral member of the tissue spacer device of FIG. 1, in
accordance with an aspect of the present invention;
[0020] FIG. 11 is a top view of the lateral member of the tissue
spacer device of FIG. 1, in accordance with an aspect of the
present invention;
[0021] FIG. 12 is a front, elevational view of the lateral member
of the tissue spacer device of FIG. 1, in accordance with an aspect
of the present invention;
[0022] FIG. 13 is a side, perspective view of a threaded rod of the
coupling mechanism of the tissue spacer device of FIG. 1, in
accordance with an aspect of the present invention;
[0023] FIG. 14 is a side, elevational view of the threaded rod of
the coupling mechanism of the tissue spacer device of FIG. 1, in
accordance with an aspect of the present invention;
[0024] FIG. 15 is a rear, perspective view of an insertion tool for
the tissue spacer device of FIG. 1, in accordance with an aspect of
the present invention;
[0025] FIG. 16 is an exploded view of the insertion tool of FIG.
15, in accordance with an aspect of the present invention;
[0026] FIG. 17 is an rear, perspective view of another insertion
tool for the tissue spacer device of FIG. 1, in accordance with an
aspect of the present invention;
[0027] FIG. 18 is a front, perspective view of one embodiment of a
vertical expandable tissue spacer device, in accordance with an
aspect of the present invention;
[0028] FIG. 19 is an exploded front, perspective view of the tissue
spacer device of FIG. 18, in accordance with an aspect of the
present invention;
[0029] FIG. 20 is a front, perspective view of an intermediate
spacer member for the tissue spacer device of FIG. 18, in
accordance with an aspect of the present invention;
[0030] FIG. 21 is a front, perspective view of a locking mechanism
for the tissue spacer device of FIG. 18, in accordance with an
aspect of the present invention;
[0031] FIG. 22 is a front perspective view of the intermediate
spacer member with the locking mechanism in position for the tissue
spacer device of FIG. 18, in accordance with an aspect of the
present invention;
[0032] FIG. 23 is a side, elevational view of the intermediate
spacer member without the locking mechanism in position for the
tissue spacer device of FIG. 18, in accordance with an aspect of
the present invention;
[0033] FIG. 24 is a front, perspective view of one embodiment of a
bottom member of the tissue spacer device of FIG. 18, in accordance
with an aspect of the present invention;
[0034] FIG. 25 is a top view of the bottom member of the tissue
spacer device of FIG. 18, in accordance with an aspect of the
present invention;
[0035] FIG. 26 is a front, elevational view of the bottom member
for the tissue spacer device of FIG. 18, in accordance with an
aspect of the present invention;
[0036] FIG. 27 is a front, elevational view of the top member for
the tissue spacer device of FIG. 18, in accordance with an aspect
of the present invention;
[0037] FIG. 28 is a rear, perspective view of an insertion tool for
the tissue spacer device of FIG. 18, in accordance with an aspect
of the present invention;
[0038] FIG. 29 is an exploded view of the insertion tool of FIG.
28, in accordance with an aspect of the present invention;
[0039] FIG. 30 is a front, perspective view of one embodiment of a
vertical and horizontal expandable tissue spacer device, in
accordance with an aspect of the present invention;
[0040] FIG. 31 is an exploded front, perspective view of the tissue
spacer device of FIG. 30, in accordance with an aspect of the
present invention;
[0041] FIG. 32 is a front, perspective view of the intermediate
spacer member for the tissue spacer device of FIG. 30, in
accordance with an aspect of the present invention;
[0042] FIG. 33 is a front, perspective view of a lateral member of
the tissue spacer device of FIG. 30, in accordance with an aspect
of the present invention;
[0043] FIG. 34 is a front, perspective view of one embodiment of a
top member of the tissue spacer device of FIG. 30, in accordance
with an aspect of the present invention;
[0044] FIG. 35 is a front, perspective view of one embodiment of a
bottom member of the tissue spacer device of FIG. 30, in accordance
with an aspect of the present invention;
[0045] FIG. 36 is a side view of a locking mechanism for the tissue
spacer device of FIG. 30, in accordance with an aspect of the
present invention;
[0046] FIG. 37 is a front, perspective view of a locking mechanism
for the tissue spacer device of FIG. 30, in accordance with an
aspect of the present invention;
[0047] FIG. 38 is a perspective view of disassembly tool for the
tissue spacer devices of FIGS. 18 and 30, in accordance with an
aspect of the present invention;
[0048] FIG. 39 is a perspective view of a bone block, in accordance
with an aspect of the present invention;
[0049] FIG. 40 is a perspective view of a bone tamp, in accordance
with an aspect of the present invention;
[0050] FIG. 41 is a perspective view of a foot print trial, in
accordance with an aspect of the present invention;
[0051] FIG. 42 is a perspective view of a spacer trial, in
accordance with an aspect of the present invention;
[0052] FIG. 43 is a perspective view of a trial handle, in
accordance with an aspect of the present invention;
[0053] FIG. 44 is a perspective view of an alternative shaped
(TLIF) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0054] FIG. 45 is a perspective view of an alternative shaped
(PLIF) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0055] FIG. 46 is a perspective view of an alternative shaped
(cervical) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0056] FIG. 47 is a perspective view of an alternative shaped
(ALIF) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0057] FIG. 48 is a perspective view of an alternative shaped
(TLIF) horizontal expandable tissue spacer, in accordance with an
aspect of the present invention;
[0058] FIG. 49 is a perspective view of an alternative shaped
(PLIF) horizontal expandable tissue spacer, in accordance with an
aspect of the present invention;
[0059] FIG. 50 is a perspective view of an alternative shaped
(cervical) horizontal expandable tissue spacer, in accordance with
an aspect of the present invention;
[0060] FIG. 51 is a perspective view of an alternative shaped
(ALIF) horizontal expandable tissue spacer, in accordance with an
aspect of the present invention;
[0061] FIG. 52 is a perspective view of an alternative shaped
(TLIF) horizontal expandable tissue spacer, in accordance with an
aspect of the present invention;
[0062] FIG. 53 is a perspective view of an alternative shaped
(PLIF) horizontal expandable tissue spacer, in accordance with an
aspect of the present invention;
[0063] FIG. 54 is a perspective view of an alternative shaped
(Cervical) horizontal expandable tissue spacer, in accordance with
an aspect of the present invention;
[0064] FIG. 55 is a perspective view of an alternative shaped
(ALIF) horizontal expandable tissue spacer, in accordance with an
aspect of the present invention;
[0065] FIG. 56 is a perspective view of an alternative shaped
(TLIF) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0066] FIG. 57 is a perspective view of an alternative shaped
(PLIF) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0067] FIG. 58 is a perspective view of an alternative shaped
(Cervical) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0068] FIG. 59 is a perspective view of an alternative shaped
(ALIF) vertical expandable tissue spacer, in accordance with an
aspect of the present invention;
[0069] FIG. 60 is a flow chart of the surgical method for inserting
an expandable tissue spacer, in accordance with an aspect of the
present invention; and
[0070] FIG. 61 is a flow chart of the method of assembly an
expandable tissue spacer, in accordance with an aspect of the
present invention.
DETAILED DESCRIPTION OF THE INVENTION
[0071] Disclosed herein are several embodiments of a tissue spacer
implant and corresponding insertion and measurement
instrumentation. Also disclosed herein are surgical implantation
methods for implanting the tissue spacer implants using the
insertion and measurement instrumentation.
[0072] In this detailed description and the following claims, the
words proximal, distal, anterior, posterior, medial, lateral,
superior and inferior are defined by their standard usage for
indicating a particular part of a bone, prosthesis or surgical
instrument according to the relative disposition of the surgical
instrument or directional terms of reference. For example,
"proximal" means the portion of an instrument positioned nearest
the torso, while "distal" indicates the part of the instrument
farthest from the torso. As for directional terms, "anterior" is a
direction towards the front side of the body, "posterior" means a
direction towards the back side of the body, "medial" means towards
the midline of the body, "lateral" is a direction towards the sides
or away from the midline of the body, "superior" means a direction
above and "inferior" means a direction below another object or
structure. Also, the terms "implant" and "device" may be used
interchangeably and have the same meaning herein.
[0073] FIG. 1 is a front perspective view of a horizontal tissue
spacer implant 100 according to one aspect of the invention. As
shown in FIG. 2, the tissue spacer 100 includes a first lateral
member 130 and a mirror image, second lateral member 131. Each
lateral member 130, 131 includes an outer (lateral directed) side
132 and an inner (medial directed) side 133. The outer side 132
being opposite the inner side 133. The lateral members 130, 131
also include top and bottom sides 134 with bone contacting surfaces
135 disposed one each of the top and bottom sides 134. Each bone
contacting surface 135 being configured to engage tissue, for
example, bone, such as, vertebrae.
[0074] According to aspects of the invention, implant 100 also
includes an intermediate spacer member 120 positioned between the
first lateral member 130 and the second lateral member 131. The
intermediate spacer member 120 includes a first lateral side 121
and a second lateral side 122 opposite the first lateral side 121.
The intermediate spacer member 120 typically includes at least two
dovetails 146 adapted to couple the inner sides 133 of the two
lateral members 130, 131 with the first and second lateral sides
121, 122 of the intermediate spacer member 120. The terms
"dovetails," "projections" and "extensions" may be used herein
interchangeably as they essentially describe the same component.
The two lateral members 130, 131 may be modular and allow the
surgeon to mix and match various shaped and configured lateral
members 130, 131 with the intermediate spacer member 120.
[0075] FIG. 1 also shows the implant construct to have angled top
and bottom surfaces when the intermediate spacer 120 is coupled to
the two lateral members 130, 131. As seen in FIG. 1 for this
example of the implant 100, the left side lateral member 130 has a
greater height than the intermediate spacer member 120 and the bone
surfaces 135 of the lateral member 130 are angled towards the
intermediate spacer member 120. The intermediate spacer member 120
has parallel top and bottom surfaces 129, 181. The intermediate
spacer member 130 is coupled to the right side lateral member 131.
The lateral member 131 has bone contacting surfaces 135 which are
angled away from the intermediate spacer member 120. The lateral
side 131 has an overall height that is less than the opposing
lateral member 130 to create overall implant angled bone contacting
surfaces (top and bottom) that may be used to correct deformities
in vivo.
[0076] FIG. 2 also shows the other elements that comprise the
horizontal tissue spacer implant 100. These include a spacer insert
110 that is positioned within an inner cavity 126 of the
intermediate spacer member 120. Coupled to the intermediate spacer
member 120 and the spacer insert 110 is a threaded rod or screw
140. The threaded rod 140 is threaded through a first threaded hole
127 in the intermediate spacer member 120 and then projects into
the second hole 113 that passes through the front wall 111 of the
spacer insert 110. As will become clear when discussing the aspects
of the invention, in one aspect, the lateral members 130, 131 may
be positioned within a space between two tissue parts (not shown),
for example, bone, whereby the intermediate spacer member 120 may
be inserted between the lateral members 130, 131. During or after
insertion of the intermediate spacer member 120 between the lateral
members 130, 131, the coupling mechanism 150 is actuated to attach
the three components: the first lateral member 130, the
intermediate spacer member 120, and the second lateral member 131.
According to aspects of the invention, the coupled members 120,
130, and 131 provide a substantially rigid implant between adjacent
tissues, for example, vertebrae. In one aspect of the invention,
intermediate spacer member 120 may be provided in a kit that
includes a plurality of widths or heights and thicknesses, whereby
the intermediate spacer member 120 may be selected from one of
these various sizes of intermediate spacer members 120 depending
upon the spacing needed between the lateral members 130, 131.
[0077] Referring now to FIGS. 3 and 4, with continued reference to
FIGS. 1-2, the spacer insert 110 is shown with a planar front wall
111 and the bullet nose end 112 that is comprised of two angle
segments 115. A through hole 113 is seen in the middle portion of
the front wall 111. The hole 113 is sized to receive the tip or
extension of the threaded rod 140. The spacer insert 110 also
includes an opening 118 that passes through the center of the
spacer insert 110. The opening 118 is sized to allow the surgeon to
pack bone grafting material into and through the entire implant
100. Side through openings 119 are also seen within the lateral
sides 114, for facilitating bone graft placement. As seen in FIGS.
3-7, the top and bottom surfaces 116, 117 of the spacer insert 110
are substantially parallel to each other and establish a thickness
that supports the top wall 129 and bottom wall 181 of the
intermediate spacer member 120 when the spacer insert 110 is within
the cavity 126.
[0078] As seen in FIG. 5, the spacer insert 110 is in place in the
inner cavity 126 of the intermediate spacer member 120. The top and
bottom surfaces 116, 117 of the spacer insert 110 are adjacent to
the top and bottom surfaces of the cavity 126. The front hole 113
of the insert 110 is also aligned with the threaded hole 127 of the
intermediate spacer member 120. Further, the angled segments 115 of
the bullet nose end 112 are positioned to contact the corresponding
angled portions 182 of the rear tapered opening 128 of the
intermediate spacer member 120. The relationship of the angled
segments 115 of the spacer insert 110 and the angled portions 182
of the intermediate spacer member 120 will function to actuate the
coupling mechanism 150 (see FIG. 1) when the threaded rod 140 is
rotated within the front hole 127.
[0079] FIGS. 6 and 7 show the intermediate spacer member 120
without the spacer insert 110 within the cavity 126. As seen in
both figures the cavity 126 has a threaded hole 127 at one end and
a tapered opening or slot 128 at the opposing end. The cavity 126
also has two opposing side slots 125 through which the spacer
insert 110 is inserted. The top and bottom walls 129, 181 are
generally parallel (see FIG. 8), but may be angled in an anterior
to posterior or medial to lateral directions, depending on the
orientation of the implant 100 in the body. Also seen in FIGS. 6
and 7 are longitudinal male dovetails 146 of the coupling mechanism
150 which are positioned on the outer sides of the intermediate
spacer member 120. The coupling mechanism 150 also includes female
dovetails 148 of the lateral members 130, 131, the spacer insert
110 and the threaded rod 140. Each pair of dovetails 146 has a top
element and a bottom element that is generally parallel to each
other when the spacer insert 110 is in a first position. When the
spacer insert 110 is moved to a second position, wherein the bullet
nose 112 makes contact with the angled portions 182 and moves in a
rearward direction (towards rear side 124) causing the gap between
the angled portions 182 of the rear tapered opening 128 to widen,
the top and bottom elements of the dovetails 146 move from a
parallel position to an angled or sloped position resulting in the
pressing contact with the lateral member female dovetails 148 and
the securement of the lateral member 130 to the intermediate spacer
member 120. Positioned at the rear side of the dovetails is a stop
or notch 184 that is sized to receive a corresponding post (not
shown) which may be inserted into openings 136 of the lateral
members 130, 131. The stop 184 facilitates holding the lateral
members 130, 131 in a constant position relative to the dovetails
146, 148.
[0080] FIG. 9 is a top view of the intermediate spacer member 120
and shows the generally rectangular outside perimeter shape of the
intermediate spacer member 120. The opposing sided dovetails 146
appear to be parallel to each other, however, each dovetail (right
and left sided) may have a slight inward draft angle when moving
from the rear side 124 to the front side 123 of the intermediate
spacer member 120. An example embodiment of this configuration may
include dovetails 146 that are wider at the rear side 124 relative
to the front side 123, alternatively this draft configuration may
be reversed.
[0081] FIGS. 10-12 show the lateral member 131, which may be a
mirror image of lateral member 130, and the lateral members 130,
131 may be movingly attached to both sides of the intermediate
spacer member 120. The lateral members 130, 131 may be mirror
images of each other when the two are positioned on either side of
the intermediate spacer member 120. The lateral members 130, 131
may have the same height and have parallel and planar bone
contacting surfaces 135. However, if the implant 100 is used to
correct angular deformities, the bone contacting surfaces 135 of
the two lateral members 130, 131 may be angled and the overall
heights of each of the two lateral members 130, 131 may be
different. An example of this configuration is shown in FIG. 1. As
seen in FIG. 11, the outer profile of the lateral members 130, 131
is generally rectangular, although it is contemplated that other
shapes and configurations may be used depending on the clinical
situation.
[0082] Generally, as seen in FIG. 10, the lateral members 130, 131
include top and bottom bone contacting surfaces 135. As also seen
in FIG. 10, similar to the top and bottom bone contacting surfaces
187 of the intermediate spacer member 120, the bone contacting
surfaces 135 for the lateral members 130, 131 are generally
parallel to each other (see FIG. 12). Further as seen in FIGS. 5-10
and 11, the bone contacting surfaces 135 and 187 may have a
roughened surface that includes teeth-like or tine structures
projecting away from the superior and inferior surfaces. One
skilled in the art would recognize that other surface treatments
may be applied to the bone contacting surfaces 135, 187 to enhance
fixation with the opposing bone surface, but not limited to sharp
tines, porous coatings, nano-coatings, bio-active/ingrowth
surfaces, ridge structures, and the like. Further, it is
contemplated that angled bone contacting surfaces, caps or plates
may be attachable to the lateral members 130, 131 to address
various skeletal deformities that are encountered clinically. It is
also understood that the bone contacting surfaces of such modular
surfaces, caps or plates may include various bioactive or bone
ingrowth coatings or have a range of surface topography
configurations.
[0083] As shown in FIGS. 10-12, the lateral members 130, 131 also
may include a central cavity 137 that is defined by the top and
bottom sides 134, an inner side 133, an outer side 132, a front
side 138, and a rear side 139. The cavity 137 may be divided by one
or more walls to create multiple cavities 137, for example, as
shown in FIG. 11 there are two cavities 137. The front side 138
also includes numerous openings 185 including a threaded hole 186.
The numerous openings 185 are also disposed on the rear side 139,
the outer side 132 and the inner side 133. Further, as seen in FIG.
11, several openings 185 are disposed on the top and bottom sides
134 to allow for the packing of bone graft material within the
cavity 137.
[0084] As shown in FIGS. 10 and 12, the inner side 133 includes a
pair of female dovetails 148 that are configured to slide onto the
male dovetails 146 of the intermediate spacer member 120. The
dovetails 146, 148, in combination, slidingly attach the lateral
members 130, 131 to the intermediate spacer member 120. Located
adjacent to the rear side 139 are two openings 136 which may
include two posts or projections (not shown) which slide into a
corresponding notch 184 in the intermediate spacer member 120 as
the intermediate spacer member 120 is moved in a front to rear
direction. For example purposes, two openings 136 are shown in
FIGS. 10 and 12, although it is understood that fewer or more
openings 136 for posts and other configured stopping projections
may be used. The posts may function to securely position the
lateral members 130, 131 relative to the intermediate spacer member
120 prior to actuation of the coupling mechanism 150.
[0085] A threaded rod or screw 140 is shown in FIGS. 13 and 14. The
rod 140 includes a head portion 141, threads 143 and a projection
or extension 142. The head portion 141 may be, for example, a hex
head, as shown, although other multi-lobed configurations may be
used depending on the tightening tool that is used. Alternatively,
it is contemplated that a hex opening or other shaped orifice may
be disposed on the head portion 141 for attaching to a drive tool
that is used to thread the rod 140 into the front hole 127 of the
intermediate spacer member 120. On the opposite end of the threaded
rod 140 from the head portion 141 is a projection 142, which may
be, for example, circular, and that extends away from a bearing end
145 along the longitudinal axis of the threaded shaft 144. The
projection 142 has a smaller diameter than the threaded shaft 144
and has, for example, a circular cross-sectional geometry although
other shapes may be used. The projection 142 is also sized to fit
into the front hole 113 of the spacer insert 110.
[0086] The implant 100 and its modular members may be fabricated
from metal, for example, stainless steel, or titanium, among other
metals, or non-metallic, for example, high molecular weight
(UHMWPE) polyethylene, or its equivalent, polymers or composites,
for example PEEK.
[0087] For example purposes, when the implant 100 is in use,
typically the operating surgeon will use an insertion tool or
instrument 300 to which the two lateral members 130, 131 are
attached, as shown in FIGS. 15-16 and discussed in greater detail
below. The tool 300 will be inserted into the space between two
pieces of tissue and adjusted to ensure the proper spacing required
between the two lateral members 130, 131 to address the clinical
need of the patient. Once the spacing is finalized, the appropriate
sized intermediate spacer member 120 is movably attached to a
second tool 400, as seen in FIG. 17 and discussed in greater detail
below, and placed between the two lateral members 130, 131. As
discussed above, the two sets of dovetails 146 on the intermediate
spacer member 120 are aligned with the corresponding dovetails 148
of the two lateral members 130, 131 and then the intermediate
spacer member 120 is moved in a front to rear direction until the
notches 184 come in contact and nest with the corresponding posts
inserted into openings 136.
[0088] Once the lateral members 130, 131 and the intermediate
spacer member 120 are slid together, the coupling mechanism 150 may
be actuated. The coupling mechanism 150, as shown in FIGS. 1 and 2,
may include the dovetails 146, 148, the spacer insert 110 with the
bullet end 112 including the angle segments 115, the intermediate
spacer member 120 including the rear opening 128 with the angled
portions 182, and the threaded rod 140. The coupling mechanism 150
is actuated by inserting or threading the threaded rod 140 into the
threaded hole 127. The projection 142 aligns and slides into the
front hole 113 of the spacer insert 110 with the bearing end 145
making contact with the planar wall 111 and causing the spacer
insert 110 to move in a rearward direction. As the spacer insert
110 moves, the angled segments 115 of the bullet end 112 make
contact with the corresponding angle portions 182 of the tapered
opening 128 of the intermediate spacer member 120. As the spacer
insert 100 continues to move in a rearward direction, the two
angled segments 115 of the bullet end 112 slide along and up the
angled incline of the angled portions 182 causing the side slots
125 to open, increase, or widen, the top and bottom walls 129, 181
to move away from each other, and the two sets of integral
dovetails 146 of the intermediate spacer member 120 to come in
pressing contact with the stationary dovetails 148 of the two
lateral members 130, 131 to lock the three members 130, 120, 131
together. The tool 300 may also be used as a distraction instrument
to remove the implant 100 from a patient by reversing the above
noted insertion method.
[0089] As shown in FIGS. 15 and 16, the tool 300 includes a body
302 with a handle portion 304 coupled to the body 302 by a
securement mechanism 306. The body 302 may also be moveably coupled
to a trigger 308 which may be positioned proximal the handle
portion 304 on a bottom side of the body 302. The handle portion
304 and the trigger 308 may be coupled to the body 302 using one or
more fasteners 303, for example, screws, pins, rivets and the like.
The body 302 may also include a distal opening 310 for receiving a
rod 312 which includes an opening 314. The rod 312 may also include
a spring 316 inserted over a portion of the proximal end of the rod
312 and a knob 318 attached to the distal end of the rod 312. The
assembled rod 312, spring 316, and knob 318 may be inserted into
the distal opening 310 enabling the trigger 308 to couple to the
rod 312 through the opening 314. In addition, the proximal end of
the rod 312 may engage the actuation mechanism 322 which is
inserted through the proximal opening 320 of the body 302.
[0090] The actuation mechanism 322 may include a first portion 324
and a second portion 326, as seen in FIG. 16. The first portion 324
is slidingly inserted into the opening 320 to couple to the rod 312
and the second portion 326 couples to the translation or scissor
mechanism 328. The second portion 326 of the actuation mechanism
322 may also slidingly engage an opening 336 in a first housing 334
prior to engaging the scissor mechanism 328. The first housing 334
may be coupled to the body 302 on the proximal end. The translation
or scissor mechanism 328 includes a first hinged pair of top
supports 330 and a second hinged pair of bottom supports 332. The
second portion 326 of the actuation mechanism 322 may couple to one
end of one of the top supports 330 and the corresponding end of one
of the bottom supports 332. The side of the scissor mechanism 328
which is coupled to the actuation mechanism 322 may also be coupled
to the first housing 334. As shown in the depicted embodiment, the
proximal end of the left side of the scissor mechanism 328 may be
rotatably coupled to the first housing 334 using at least one
fastener 338, for example, a screw, pin, or the like. The proximal
end of the right side of the scissor mechanism 328 may be rotatably
coupled to a second housing 340 using at least one fastener 338. In
addition, the distal end of the right side of the scissor mechanism
328 may be slidingly coupled to the second housing 340 through
opening 342 using, for example, a pin member. As shown in FIG. 15,
the trigger 308 is coupled to the actuation mechanism 322 which is
in turn coupled to the scissor mechanism 328 and the scissor
mechanism 328 is coupled to the first and second positioning
mechanisms 344, 352. The scissor mechanism 328 is used to convert
the proximal-distal translation of the actuation mechanism 322 into
horizontal expansion or translation of the housings 334, 340 which
are coupled to the lateral members 130, 131.
[0091] With continued reference to FIGS. 15 and 16, a measuring
device 342 may be coupled to the second housing 340 at the distal
end to measure the distance between the first housing 334 and the
second housing 340, which in turn provides the measurement of the
distance between the lateral members 130, 131. A first positioning
mechanism 344 may couple with a spring 346 for insertion into the
first housing 334. The proximal end 348 of the first positioning
mechanism 344 is configured to engage a lateral member 130 and may
extend out of the proximal end of the first housing 334 to couple
to the lateral member 130. The first housing 334 may also include
an alignment protrusion 350 for engaging the lateral member 130 for
attachment of the first positioning mechanism 344 prior to
insertion of the implant 100 into the patient. Similarly, a second
positioning mechanism 352 may couple with a spring 354 for
insertion into the second housing 340. The proximal end 356 of the
second positioning mechanism 352 is configured to engage a lateral
member 131 and may extend out of the proximal end of the second
housing 340 to couple to the lateral member 131. The second housing
340 may also include an alignment protrusion 358 for engaging the
lateral member 131 for attachment of the second positioning
mechanism 352 prior to insertion of the lateral members 130, 131
into the patient.
[0092] The second insertion tool 400 for the implant 100 is shown
in FIG. 17. The second tool 400 includes a handle 402 with an
actuation mechanism 404. The actuation mechanism 404 is configured
to enable the engagement shaft 406 to be secured in a first
position wherein the implant 100 is secured to the proximal end 408
of the engagement shaft 406 for insertion into a patient and then
upon actuation of the actuation mechanism 404 the engagement shaft
406 may be moved to a second position in order to remove the tool
400 leaving a intermediate spacer member 120 of the implant 100 in
the patient. The tool 400 may also include an alignment head 410
for alignment of the intermediate spacer member 120 on the tool 400
for insertion into the patient. The tool 400 may further include a
moveable housing 412 coupled to a tab 414 to assist in the
alignment and insertion of the intermediate spacer member 120
between two lateral members 130, 131.
[0093] FIGS. 18 and 19 show another embodiment of a tissue spacer
implant. According to aspects of the invention, a vertical tissue
spacer implant 200 includes an intermediate spacer member 220
positioned between a top member 230 and a bottom member 260. The
intermediate spacer member 220 includes a top side 221 and a bottom
side 285 opposite the top side 221. The intermediate spacer member
220 typically includes at least two pairs of dovetails 224 disposed
on the top side 221 and the bottom side 285 adapted to couple the
bottom surface 232 of the top member 230 and the top surface 261 of
the bottom member 260, respectively. The top member 230 and the
bottom member 260 may be modular and allow the surgeon to mix and
match various shaped, sized, and configured members 230, 260 chosen
from a kit with the intermediate spacer member 220. The kit may
include a plurality of different sized members 220, 230, 260
enabling the surgeon to select the necessary components for
insertion into each specific patient.
[0094] For example purposes, FIG. 18 shows the implant construct to
have planar top and bottom surfaces, although these surfaces for
some embodiments may be angled. As seen in FIG. 18 for this example
of the implant 200, the top surface 231 of the top member 230 is
planar and the bottom surface 262 of the bottom member 260 is also
planar. In alternative embodiments, the top surface 231 may be, for
example, angled from left to right and the bottom surface 262 may
be, for example, angled from left to right. It is understood that
the angulations of the top and bottom surfaces 231, 262 may also be
reversed or, alternatively, both the top surface 231 and the bottom
surface 262 could be straight. If the bone contacting surfaces 234,
264 of the implant 200 are angled, the implant 200 may be used to
correct deformities in vivo.
[0095] FIG. 19 is an exploded view showing the other elements that
comprise the vertical tissue spacer implant 200. The implant 200
may include the intermediate spacer member 220 and a locking
mechanism 240 which may couple to the intermediate spacer member
220. The locking mechanism 240 may be inserted through an opening
213 in the intermediate spacer member 220. As will become clear
when discussing the aspects of the invention, in one aspect, the
top member 230 and the bottom member 260 may be positioned adjacent
to the top and bottom margins of a space that exists between two
tissue parts (not shown), for example, bone, whereby the
intermediate spacer member 220 may be inserted between the top
member 230 and the bottom member 260. During or after insertion of
the intermediate spacer member 220 between the top member 230 and
the bottom member 260, a coupling mechanism 250 may be actuated to
attach the three components 220, 230 and 260 together as the
implant 200. According to aspects of the invention, the coupled
members 220, 230 and 260 provide a substantially rigid implant
between adjacent tissues, for example, vertebrae. In one aspect of
the invention, the intermediate spacer member 220 may be provided
in a kit that includes a plurality of widths or heights, whereby
the intermediate spacer member 220 may be selected from the kit
which includes one of these various sizes of intermediate spacer
members 220 depending upon the spacing needed between the top
member 230 and the bottom member 260. Various sizes of the top
member 230 and the bottom member 260 may also be components of the
kit.
[0096] Seen in FIG. 20 is the intermediate spacer member 220. The
intermediate spacer member 220 includes two openings 226 that
extend through the center and are separated by a central wall 214.
The openings 218 are sized to allow the surgeon to pack bone
grafting material into and through the entire implant 200. The
intermediate spacer member 220 also includes a threaded hole 227
and an opening 213. The threaded hole 227 is located at one end and
offset from the midline of the front wall 222 and the opening 213
is located at the same end as and offset from the midline on a side
opposite the threaded hole 227 on the front wall 222. The opening
213 is sized to receive the tip or extension 242 of the locking
mechanism 240, as seen in FIG. 21. A rear wall 223 is opposite the
front wall 222. The openings 226 also have two side walls 225 that
define the length of the implant 200. The generally rectangular
outside perimeter shape of the intermediate spacer member 220 is
seen in FIG. 20.
[0097] A locking mechanism 240 is seen in FIG. 21. The locking
mechanism 240 includes a head portion 241 and an extension portion
242. The head portion 241 may engage a portion of the front wall
222 when inserted into the opening 213. The extension portion 242
may include at least one leg 243 and a protrusion 244 on each leg
242. In the illustrated embodiment there are, for example, two legs
243 each including a protrusion 244. The legs 243 expand after
insertion into the opening 213 to engage the top member 230 and the
bottom member 260.
[0098] Also seen in FIGS. 20 and 22 are part of the elements of the
coupling mechanism 250, specifically, the longitudinal female
dovetails 224 positioned on the outer sides of the side walls 225
of the intermediate spacer member 220. The opening 213 is also an
element of the coupling mechanism 250. The two sets of dovetails
224 that are located on the outer surfaces of the two opposing side
walls 225 are generally parallel to each prior to insertion of the
locking mechanism 240. When the locking mechanism 240 is inserted
into opening 213, the locking mechanism 240 is moved in a rearward
direction (towards rear wall 223) causing the protrusions 244 to
flex toward each other. As the locking mechanism 240 is moved
rearward, the protrusions 244 enter the central cavities 237, 267
of the top and bottom members 230, 260. The protrusions 244 are
able to snap outward, resulting in the capturing and securement of
the top and bottom members 230, 260 to the intermediate spacer
member 220. The locking mechanism 240 may be made of a deformable
or elastic material to enable deformation for insertion and
removal. In an alternative embodiment, the top aspect and bottom
aspect of the rear wall 223 may include, for example, four notches
(not shown) that are sized to receive corresponding posts (not
shown) of the top member 230 and bottom member 260 respectively.
The notches may facilitate holding the top and bottom members 230,
260 in a constant position relative to the dovetails 224 when the
intermediate spacer member 220 is slid between them.
[0099] FIG. 23 is a side view of the intermediate spacer member
220. This view shows one pair of the dovetails 224 and the parallel
relationship between the upper element of the dovetail 224 relative
to the lower element of the dovetail 224. The planar configuration
of the top and bottom sides 221, 285 is also seen.
[0100] FIGS. 24-26 show the bottom member 260 that is movingly
attached to the bottom side 285 of the intermediate spacer member
220. For brevity sake, only the bottom member 260 will be described
as the top member 230 is a mirror image and has the same structural
elements. These can be seen in comparing FIGS. 26 (bottom member
260) to FIG. 27 (top member 230).
[0101] Generally, as seen in FIG. 18, the top and bottom members
230, 260 include a bone contacting surface 234, 264. As seen in
FIG. 18, the bone contacting surfaces 234, 264 for the top and
bottom members 230, 260 are generally parallel to each other and
are either angled or straight. Further, the bone contacting
surfaces 234, 264 may have a roughened surface that includes
teeth-like or tine structures projecting away from the superior and
inferior surfaces. One skilled in the art would recognize that
other surface treatments may be applied to the bone contacting
surfaces 234, 264 to enhance fixation with the opposing bone
surface, but not limited to sharp tines, porous coatings,
nano-coatings, bio-active/ingrowth surfaces and ridge structures.
Further, it is contemplated that the bone contacting surfaces, caps
or plates may be attachable to the top and bottom members 230, 260
to allow for modular components to address various skeletal
deformities that are encountered clinically. It is also understood
that the bone contacting surfaces of such modular surfaces, caps or
plates may include various bioactive or bone ingrowth coatings or
have a range of surface topography configurations.
[0102] As seen in FIGS. 24 and 25, the bottom member 260 also may
include at least one central cavity 267 that is defined by the
front wall 268 and the back wall 269. A middle wall 281 may divide
the cavity 267 into two separate cavities. The cavity 267 allows
the surgeon to pack bone graft material through the implant
200.
[0103] As shown in FIGS. 24 and 26, the top surface 261 includes a
pair of male dovetails 265 that are configured to be aligned and
slid into the corresponding female dovetails 224 of the
intermediate spacer member 220. The dovetails 265, 235, and 224, in
combination, couple the bottom member 260, the top member 235
respectively, to the intermediate spacer member 220.
[0104] As seen in FIGS. 24-27, located on the bottom surface 232,
top surface 261 of the back wall 239, 269 is a projection 236, 266
that engages the rear wall 223 of the intermediate spacer member
220 as the intermediate spacer member 220 is moved in a front to
rear direction when the implant 200 is assembled in situ. For
example purposes, the two projections 236, 266 are shown in FIGS.
24 and 27, although it is understood that there could be multiple
projections or other configured stopping projections may be used.
The projections 236, 266 function to securely position the top
member 230 and the bottom member 260 relative to the intermediate
spacer member 220 prior to actuation of the coupling mechanism 250.
The projections 236, 266 may also assist in preventing the
intermediate spacer member 220 from sliding out the rear end of the
top and bottom members 230, 260 during insertion of the
intermediate spacer member 220. In addition, the top and bottom
members 230, 260 may also include front projections 233, 263 which
may assist in positioning the top and bottom members 230, 260
relative to the intermediate spacer member 220.
[0105] Each of the edges of the dovetails 235, 265 appear to be
straight, however, each dovetail (right and left sided) may have a
slight inward draft angle when moving from the rear wall 223 to the
front wall 222 of the intermediate spacer member 220. An example
embodiment of this configuration may be that the dovetails 235, 265
may be wider at the back wall 239, 269 relative to the front wall
238, 268 or this draft configuration could be reversed. The angled
draft may be integrated into the dovetails 235, 265 to ensure
maximum contact with the female dovetails 224 of the intermediate
spacer member 220 prior to actuation of the coupling mechanism
250.
[0106] As seen in FIG. 25, the outer profile of the bottom member
260 (this is the same for the top member 230) is generally
rectangular, although it is contemplated that other shapes and
configurations may be used depending on the clinical situation.
[0107] FIGS. 26 and 27 are front elevational views of the top
member 230 (FIG. 27) and the bottom member (FIG. 26). As shown, the
bone contacting surfaces 234, 264 are straight. Although not shown,
it is contemplated that the bone contacting surfaces 234, 264 may
be for example, angled from left to right or in the reverse
orientation. Angling the bone contacting surfaces 234, 264 allows
the user to utilize the implant 200 to address angular deformities.
Also seen is that the bottom surface 232 for the top member 230 and
the top surface 261 for the bottom member 260 are flat. This is
done to ensure easy assembly with the mating dovetails and maximum
load transfer between the three joined components.
[0108] For example purposes, when the implant 200 is in use,
typically the operating surgeon will use an insertion tool or
instrument 500 (See FIGS. 28 and 29) to which top and bottom
members 230, 260 are attached. The tool end to which the members
are attached will be inserted into the space between the two pieces
of tissue and adjusted to ensure the proper spacing required
between the two members 230, 260 to address the clinical need is
achieved. Once the spacing is finalized, the appropriate sized
intermediate spacer member 220 is movably attached to a second
insertion tool and slid between the top and bottom members 230,
260. The second insertion tool may be of the type described above
with reference to tool 400, although the alignment head 410 may be
replaced with an alternative alignment head configured to mate with
the intermediate spacer member 220. As discussed above, the two
pairs of dovetails 224 on the intermediate spacer member 220 are
aligned with the corresponding pair of dovetails 235 for the top
member 230 and the corresponding pair of dovetails 265 for the
bottom member 260 and then the intermediate spacer 220 is slid in a
front to rear direction until the rear wall 223 comes into contact
with the protrusions 236, 266.
[0109] Once the intermediate spacer member 220 is slid to join
together with the top member 230 and the bottom member 260, the
coupling mechanism 250 may be actuated. The coupling mechanism 250
as shown in FIGS. 18 and 19 likely includes the male and female
dovetail pairs 224, 235, 265, the intermediate spacer member 220,
and the locking mechanism 240. The coupling mechanism 250 is
actuated by inserting the locking mechanism 240 into the opening
213. To insert the locking mechanism 240 into the opening 213, the
legs 243 of the extension portion 242 are depressed and slide into
the opening 213 of the intermediate spacer member 220 until the
head portion 241 makes contact with the front wall 211. As the
locking mechanism 240 is inserted into the opening 213 the legs 243
and protrusions 244 flex toward each other and once the protrusions
extend into the central cavities 237, 267 they snap outward
resulting in the capturing and securement of the top and bottom
members 230, 260 to the intermediate spacer member 220. When the
top and bottom members 230, 260 engage the intermediate spacer
member 220 the two pairs of dovetails 235 and 265 of the top and
bottom members 230, 260 engage the pair of dovetails 224 of the
intermediate spacer member 220. The tool 500 may also be used as a
disassembly instrument to remove the implant 200 from a patient by
reversing the above noted insertion method.
[0110] The implant 200 and its modular members may be fabricated
from metal, for example, stainless steel, or titanium, among other
metals, or non-metallic, for example, high molecular weight
(UHMWPE) polyethylene, or its equivalent, polymers or composites,
for example PEEK.
[0111] FIGS. 28 and 29 show the tool 500, which is similar to the
tool 300, as shown in FIGS. 15 and 16, although the tool 500
expands in a vertical direction. The tool 500 includes a body 502,
with a handle portion 504 coupled to the body 502 by a securement
mechanism 506. The body 502 may also be moveably coupled to a
trigger 508 which may be positioned proximal the handle portion 504
on a bottom side of the body 502. The handle portion 504 and the
trigger 508 may be coupled to the body 502 using one or more
fasteners 503, for example, screws, pins, rivets and the like. The
body 502 may also include a distal opening 510 for receiving a rod
512 which includes an opening 514. The rod 512 may also include a
spring 516 inserted over a portion of the proximal end of the rod
512 and a knob 518 attached to the distal end of the rod 512. The
assembled rod 512, spring 516, and knob 518 may be inserted into
the distal opening 510 enabling the trigger 508 to couple to the
rod 512 through the opening 514. In addition, the proximal end of
the rod 512 may engage the actuation mechanism 522 which is
inserted through the proximal opening 520 of the body 502.
[0112] The actuation mechanism 522 may include a first portion 524
and a second portion 526, as seen in FIG. 29. The first portion 524
is slidingly inserted into the opening 520 to couple to the rod 512
and the second portion 526 couples to the translation or scissor
mechanism 528. The second portion 526 of the actuation mechanism
522 may also slidingly engage an opening 536 in a first housing 534
prior to engaging the scissor mechanism 528. The first housing 534
may be coupled to a proximal end of the body 502. The translation
or scissor mechanism 528 includes a first hinged pair of supports
530 and a second hinged pair of supports 532. The second portion
526 of the actuation mechanism 522 may couple to one end of one of
the supports 530 and the corresponding end of one of the supports
532. The bottom of the scissor mechanism 528 which is coupled to
the actuation mechanism 522 may also be coupled to the first
housing 534. As shown in the depicted embodiment, the proximal end
of the bottom of the scissor mechanism 528 may be rotatably coupled
to the first housing 534 using at least one fastener 538, for
example, a screw, pin, or the like. The proximal end of the top of
the scissor mechanism 528 may be rotatably coupled to a second
housing 540 using at least one fastener 538. In addition, the
distal end of the top of the scissor mechanism 528 may be slidingly
coupled to the second housing 540 through opening 542 using, for
example, a pin member. In the depicted embodiment, the trigger 508
is coupled to the actuation mechanism 522 which is in turn coupled
to the scissor mechanism 528 and the scissor mechanism 528 is
coupled to the first and second housings 534, 540. The scissor
mechanism 528 is used to convert the proximal-distal translation of
the actuation mechanism 522 into vertical expansion or translation
of the housings 534, 540 which are coupled to the top and bottom
members 230, 260.
[0113] With continued reference to FIGS. 28 and 29, a measuring
device 542 may be coupled to the second housing 540 at the distal
end to measure the distance between the first housing 534 and the
second housing 540, which in turn provides the measurement of the
distance between the top and bottom members 230, 260. The first
housing 534 may also include a coupling protrusion 550 for engaging
the bottom member 260 prior to insertion of the implant 100 into
the patient. Similarly, the second housing 540 may also include a
coupling protrusion 558 for engaging the top member 230 for
attachment to the second housing 540 for insertion of the top and
bottom members 230, 260 into the patient.
[0114] An alternative embodiment tissue spacer implant is shown in
FIGS. 30 and 31. According to aspects of the invention, the tissue
spacer implant 600 is a vertical and horizontal expandable implant.
The tissue spacer implant 600, in one embodiment, includes an
intermediate spacer member 620 which engages a lateral member 610
and the coupled intermediate spacer member 620 and the lateral
member 610 are positioned between and couple to a top member 630
and a bottom member 660. For example purposes, FIG. 30 shows the
implant construct to have planar top and bottom surfaces, although
these surfaces for some embodiments may be angled as described
above with reference to implants 100, 200. If the bone contacting
surfaces 634, 664 of the implant 600 are angled, the implant 600
may be used to correct deformities in vivo.
[0115] As shown in FIG. 32, the intermediate spacer member 620
includes a top side 621 and a bottom side 685 opposite the top side
621, as well as a first lateral side 680 and a second lateral side
681 opposite the first lateral side 680. The intermediate spacer
member 620 typically includes at least two pairs of dovetails 624
disposed on the top side 621 and the bottom side 685 adapted to
couple the bottom surface 632 of the top member 630, the top
surface 661 of the bottom member 660, respectively, and the inner
side 613 of the lateral member 610 with the intermediate spacer
member 620. The top member 630, bottom member 660, and lateral
member 610 may be modular and allow the surgeon to mix and match
various shaped, sized, and configured members 610, 630, and 660
chosen from a kit with the intermediate spacer member 620. The kit
may include a plurality of differently sized and shaped members
610, 620, 630, 660 so that the surgeon can select the desired
components at the time of surgery. The intermediate spacer member
620 may also include two openings 626 that extend through the
center and are separated by a central wall 625. The openings 626
are configured for packing bone grafting material into and through
the entire implant 600. The intermediate spacer member 620 also has
a front wall 622 and a rear wall 623. The front wall 622 may
include a cutout 686 with a passageway 628 extending into the
opening 626. The intermediate spacer member 620 also includes a
threaded hole 627 located in the front wall 622 and offset to one
side and the passageway 628 is offset to the side opposite the hole
627. The passageway 628 is configured to receive the tip or
extension 642 of the locking mechanism 640, as shown in FIG. 30.
The hole 627 is configured to engage an insertion device (not
shown) for inserting the intermediate spacer member 620 between the
members 610, 630, 660. The spacer member 620 also includes a rear
wall 623 opposite the front wall 622 and the rear wall 623 may
include a notch 629. The openings 626 are positioned between the
front and rear walls 622, 623 and the lateral sides 680, 681 which
define the length of the implant 600. The intermediate spacer
member 620 may also include longitudinal female dovetails 624
positioned on the outer sides of the lateral sides 680, 681, as
shown in FIG. 32. The two sets of dovetails 624 that are located on
the outer surfaces of the two opposing lateral sides 680, 681 are
generally parallel to each other prior to insertion of a locking
mechanism 640.
[0116] As shown in FIG. 33, the lateral member 610 includes an
outer (lateral directed) side 611 and an inner (medial directed)
side 612 opposite the outer side 611. The lateral member 610 also
includes top and bottom sides 613 with bone contacting surfaces 614
disposed on each of the top and bottom sides 613. Each bone
contacting surface 614 being configured to engage tissue, for
example, bone, such as, vertebrae, as discussed above in greater
detail with respect to the bone contacting surfaces 135 of implant
100 and which for brevity sake will not be discussed again here.
The lateral member 610 may also include a central cavity 615 that
is defined by the outer side 611, inner side 612, a front side 616
and a rear side 617. The cavity 615 may be divided by one or more
walls 618 to create multiple cavities 615, for example, as shown in
FIG. 33, there are two cavities 615. The cavities 615 are
configured to enable the packing of bone graft material within the
cavities 615.
[0117] Also shown in FIG. 33, the front side 616 of the lateral
member 610 also includes a threaded hole 619 and an engagement
member 602. The threaded hole 619 may be used for insertion of the
lateral member 610 into the patient. The engagement member 602 may
be configured to mate with the cutout portion 686 of the front wall
622 of the spacer member 620 and may include an opening 604 which
aligns with the passageway 628 for insertion of a locking mechanism
640. The inner side 612 of the lateral member 610 also includes a
pair of female dovetails 606 that are configured to slide onto
engage the dovetails 636, 666 of the top and bottom members 630,
660, respectively.
[0118] As seen in FIGS. 34 and 35, the top member 630 and bottom
member 660 are mirror images of each other and have the same
structural elements. The top member 630 is movingly attached to the
top side 621 of the spacer member 620 and the bottom member 660 is
movingly attached to the bottom side 685 of the spacer member 620.
The top and bottom members 630, 660 include bone contacting
surfaces 634, 664, which are generally parallel to each other and
are either angled or straight. The bone contacting surfaces 634,
664 are of the type described above with reference to bone
contacting surfaces 234, 264 and for brevity sake will not be
described again here. In addition, the top and bottom members 630,
660 also include a notch 683 on the front wall 638, 668 configured
to engage the locking mechanism when inserted into the implant 600.
The top and bottom members 630, 660 may also include an opening 684
near the back wall 639, 669 for receiving one or more projections
(not shown). The projections may be designed to engage the notch
629 of the spacer member 620 to securely position the spacer member
620 relative to the top and bottom members 630, 660 prior to
insertion of the locking mechanism 640. The projections may also
assist in preventing the spacer member 620 from sliding out the
rear end of the top and bottom members 630, 660 during insertion of
the spacer member 620.
[0119] FIGS. 34 and 35 also show the top and bottom members 630,
660 which may include at least one central cavity 637, 667 that is
defined by the front wall 638, 668 and the back wall 639, 669,
respectively. A middle wall 682 may divide the cavity 637, 667 into
two separate cavities. The cavities 637, 667 enable a surgeon to
pack bone growth material through the implant 600. The top and
bottom members 630, 660 also each include a pair of male dovetails
or angled slots 635, 665. One skilled in the art would understand
that corresponding dovetails, angled slots and other
correspondingly shaped configurations may be used interchangeably
to align and secure the members 610, 630, 660 together. The male
dovetails 635, 665 are configured to be aligned and slid into the
corresponding female dovetails 624 of the spacer member 620. The
dovetails 624, 635, 665, in combination, couple the top and bottom
members 630, 660 to the spacer member 620. The top and bottom
members 630, 660 may also each include a third, female dovetail
636, 666 on the medial side 633, 663. The female dovetails 636, 666
are configured to align and engage with the corresponding pair
female dovetails 606 of the lateral member 610. The dovetails 606,
636, 666 in combination, couple the lateral member 610 to the top
and bottom members 630, 660. Thus, the dovetails 624, 635, 665,
606, 636, 666 are configured to couple the top and bottom members
630, 660 to the spacer member 620 and the lateral member 610. As
described above with reference to implants 100, 200, the dovetails
624, 635, 665, 606, 636, 666 may be straight or include a draft
angle and for brevity sake will not be described again here.
[0120] Once the four components 610, 620, 630, and 660 are coupled
by the dovetails 624, 635, 665, 606, 636, 666, a locking mechanism
640 may be inserted through the opening 604 and the passageway 628
to engage the lateral member, intermediate spacer, top and bottom
members 610, 620, 630, 660. As shown in FIGS. 36 and 37, the
locking mechanism 640 includes a head portion 641 and an extension
portion 642. The head portion 641 may engage a portion of the
engagement member 602 as well as the notches 683 in the top and
bottom members 630, 660. The extension portion 642 may include at
least one leg 643, a protrusion 644 on each leg 643, and an opening
645. In the illustrated embodiment, there are, for example, two
legs 643 each including a protrusion 644 for engaging the top and
bottom members 630, 660. The legs 643 of the locking mechanism 640
are depressed in order to be inserted through opening 604 and
passageway 628. After the locking mechanism 640 passes through the
opening 604 in the lateral member 610, the legs 643 may expand or
spring out to engage the walls of the central cavities 637, 667 of
the top and bottom members 630, 660. The opening 645 may be used to
remove the locking mechanism 640 from the implant 600. The locking
mechanism 640 may be made of a deformable or elastic material to
enable deformation for insertion and removal. A tool 700, as shown
in FIG. 38, may be used to remove the locking mechanism 640 by
engaging the opening 645.
[0121] As shown in FIG. 38, the tool 700 may include a handle 702
with a shaft 704 extending out from the handle 702. The shaft 704
may include a hook 706 on the end opposite the handle 702. The hook
706 may be configured to engage the opening 645 in the locking
mechanism 640 to remove the locking mechanism 640 from the implant
600.
[0122] Further, it is contemplated that angled bone contacting
surfaces, caps, or plates may be attached to the lateral member
610, the top member 630, and the bottom member 660 to address
various skeletal deformities that are encountered clinically. It is
also understood that the bone contacting surfaces of such modular
surfaces, caps, or plates may include various bioactive or bone
ingrowth coatings or have a range of surface topography
configurations. In addition, the inner surfaces of the lateral
member 610, top member 630, and bottom member 660 and the outer
surfaces of the spacer member 620 may be flat to ensure easy
assembly with the mating dovetails and maximum load transfer
between the four joined components.
[0123] The implant 600 may be inserted into a patient using
multiple insertion tools. For example, a first insertion tool of
the type described above with reference to tool 500 may couple to
the top and bottom members 630, 660 for implantation. In addition,
a second insertion tool may couple to the lateral member 610 and be
configured to travel along first and second housings, similar to
the first and second housings 534, 540 of the tool 500. A third
tool, for example, a tool similar to tool 400 with an alignment
head configured to mate with the intermediate spacer member 620,
may then be coupled to the intermediate spacer member 620 for
insertion between the lateral member 610 and the top and bottom
members 630, 660.
[0124] Additional figures of various sizing instruments have also
been attached hereto. FIG. 39 shows a bone block 700 that is used
for implant component selection and verification. FIG. 40 shows a
bone tamp 710 that may be used to pack bone grafting material
within the implants 100, 200, 600. A foot print trial 720 as seen
in FIG. 41 may be used for in situ sizing purposes. FIG. 42 shows a
spacer trial 730 that may used to ensure that the proper gap is
achieve in situ or to determine what sized intermediate spacer
block should be used to assemble the implants 100, 200, 600. A
trial handle 740 that connects to the foot print trial 720 or other
implant trials is seen in FIG. 43.
[0125] As shown in FIG. 60, the example surgical method for using
the tissue spacer implants 100, 200, 600 is well known in the art,
including the appropriate surgical exposure and dissection
techniques. The method includes, obtaining the properly sized and
configured medical device 800, for example, lateral members 130,
131, top and bottom members 230, 260 or 630, 660 and attaching
these elements to a distraction/insertion tool 810, for example,
tools 300, 500. Following the attachment of the lateral members
130, 131, top and bottom members 230, 260, or 630, 660 to the
distraction tool, the lateral members 130, 131, top and bottom
members 230, 260 or 630, 660 are placed between two tissue bodies
820. For example purposes only, we shall describe herein the
technique as used in maintaining the space between two vertebral
bodies. The ends of the distraction tool with the coupled and
aligned lateral members 130, 131, top and bottom members 230, 260
or 630, 660 are positioned within a space within a spinal column
with the lateral members 130, 131, top and bottom members 230, 260
or 630, 660 engaging the respective adjacent vertebral bodies. Upon
completion of the distraction, spacing, or maintenance of the
existing space with the instrument 300, 500 and calculation of the
necessary thickness or width of the intermediate spacer member 120,
220, 620 the appropriate sized intermediate spacer member 120, 220,
620 is attached to an insertion tool, for example, tool 400. The
intermediate spacer member 120, 220, 620 is slidingly engaged with
the distraction instrument and the spacer member 120, 220, 620 is
oriented and tracked into the space between at least a first and
second member 830, for example, the two lateral members 130, 131,
top and bottom members 230, 260 or 630, 660 allowing the pairs of
dovetails 124, 224, 624 for the intermediate spacer member 120,
220, 620 to mate with the dovetails for the corresponding lateral
members 130, 131, top and bottom members 230, 260, or top and
bottom members 630, 660. Thus, finalizing the assembly of the
implant 100, 200 into a single construct. For the implant 600, the
properly sized and configured lateral member 610 is attached to an
insertion tool, for example, a tool similar to tool 400 and
slidingly engaged with the distraction instrument and the lateral
member 610 is oriented and tracked into the space beside the top
and bottom members 630, 660. Thus, finalizing the assembly of the
implant 600 into a single construct.
[0126] The method may further include actuating the coupling
mechanism 150 by inserting the threaded rod 140 into the hole 127
of the intermediate spacer members 120 causing the spacer insert
110 to translate and securing the intermediate spacer member 120 to
the two lateral members 130, 131 via the coupling mechanism 150,
thus fixing the implant 100 between two vertebral bodies within a
patient's spinal column 840. Alternatively, the method may further
include actuating the coupling mechanism 250, 650 by inserting the
locking mechanism 240, 640 into the opening 213, 613 of the
intermediate spacer members 220, 620 causing the locking mechanism
240, 640 to engage the top and bottom members 230, 260 and the
coupling mechanisms 150, 250 to couple the dovetails together, thus
fixing the implant 200, 600 between two vertebral bodies within a
patient's spinal column 840.
[0127] The method may further include detaching the
distraction/insertion instrument from the two lateral members 130,
top and bottom members 230, 260 or 630, 660 and removing the
instrument from inside the living body. Instruments may be removed
from intermediate spacer members 120, 220, 620 and lateral member
610 and removed from inside the living body.
[0128] It should be understood by those skilled in the art that the
surgical method described herein may also include alternatively,
using a modular footplate that has been coupled to an alternative
embodiment of the lateral members 130, 131, the top and bottom
members 230, 260, or lateral, top and bottom members 610, 630, 660
to accommodate various clinical deformities or bone growth
coatings.
[0129] Alternative shaped embodiments of the vertical and
horizontal tissue spacers are also shown in FIGS. 44-59. For
example, these include a vertical transforaminal lumbar interbody
fusion ("TLIF") spacer (FIG. 44), a vertical posterior lumbar
interbody fusion ("PLIF") spacer (FIG. 45), a vertical cervical
spacer (FIG. 46), a vertical anterior lumbar interbody fusion
("ALIF") spacer (FIG. 47), a horizontal TLIF spacer (FIG. 48), a
horizontal PLIF spacer (FIG. 49), a horizontal cervical spacer
(FIG. 50), and a horizontal ALIF spacer (FIG. 51), a horizontal
TLIF spacer (FIG. 52), a horizontal PLIF spacer (FIG. 53), a
horizontal cervical spacer (FIG. 54), and a horizontal ALIF spacer
(FIG. 55), a vertical TLIF spacer (FIG. 56), a vertical PLIF spacer
(FIG. 57), a vertical cervical spacer (FIG. 58), a vertical ALIF
spacer (FIG. 59). The vertical and horizontal tissue spacers shown
in FIGS. 44-51 may include a threaded rod or screw of the type
described above with reference to threaded rod or screw 140 for
implant 100. The horizontal and vertical tissue spacers shown in
FIGS. 52-59 may include a locking mechanism of the type described
above with reference to the locking mechanism 240 of implant
200.
[0130] As shown in FIG. 61, a method for assembling an expandable
tissue spacer implant is shown. The method may include obtaining an
intermediate spacer member with a coupling mechanism 900, selecting
a first member with a first pair of projections 910, selecting a
second member with a second pair of projections 920, engaging the
first pair of projections of the first member with the coupling
mechanism of the intermediate spacer member and engaging the second
pair of projections of the second member with the coupling
mechanism of the intermediate spacer member 930, and inserting a
locking mechanism into the intermediate spacer member to actuate
the coupling mechanism and secure the first member and second
member to the intermediate spacer member 940.
[0131] The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the invention. As used herein, the singular forms "a", "an" and
"the" are intended to include the plural forms as well, unless the
context clearly indicates otherwise. It will be further understood
that the terms "comprise" (and any form of comprise, such as
"comprises" and "comprising"), "have" (and any form of have, such
as "has", and "having"), "include" (and any form of include, such
as "includes" and "including"), and "contain" (and any form of
contain, such as "contains" and "containing") are open-ended
linking verbs. As a result, a method or device that "comprises,"
"has," "includes," or "contains" one or more steps or elements
possesses those one or more steps or elements, but is not limited
to possessing only those one or more steps or elements. Likewise, a
step of a method or an element of a device that "comprises," "has,"
"includes," or "contains" one or more features possesses those one
or more features, but is not limited to possessing only those one
or more features. Furthermore, a device or structure that is
configured in a certain way is configured in at least that way, but
may also be configured in ways that are not listed.
[0132] The invention has been depicted and described with reference
to example embodiments. It will be understood that the
architectural and operational embodiments described herein are
exemplary of a plurality of possible arrangements to provide the
same general features, characteristics, and general system
operation. Modifications, substitutions, and alterations will occur
to others upon a reading and understanding of the preceding
detailed description. It is intended that the invention be
construed as including all such modifications and alterations and
therefore these changes be considered to be within the scope of the
following claims.
* * * * *