U.S. patent application number 11/470810 was filed with the patent office on 2008-04-10 for intercostal spacer device and method for use in correcting a spinal deformity.
This patent application is currently assigned to WARSAW ORTHOPEDIC, INC.. Invention is credited to Kent M. ANDERSON, Ole STOKLUND.
Application Number | 20080086115 11/470810 |
Document ID | / |
Family ID | 38917444 |
Filed Date | 2008-04-10 |
United States Patent
Application |
20080086115 |
Kind Code |
A1 |
STOKLUND; Ole ; et
al. |
April 10, 2008 |
INTERCOSTAL SPACER DEVICE AND METHOD FOR USE IN CORRECTING A SPINAL
DEFORMITY
Abstract
An intercostal spacer device for placement between two adjacent
ribs, includes a spacer member and at least one pair of arms that
extend from a first end of the spacer member and at least one pair
of arms that extend from a second end of the spacer member. The
intercostal spacer device may also include a flexible, fillable
container for containing an injectable material that is
compressible following implantation. The container is impermeable
to the material it will be filled with. A structural mesh, for
example, made of PET fabric and interwoven shape-memory alloy wire,
provides structure for and containment of the container, as well as
shape control of the intercostal spacer device. The material can be
injected into the container through a conduit. The intercostal
spacer device is sized and configured to allow for placement into
the intercostal space to produce a force for correcting a spinal
deformity.
Inventors: |
STOKLUND; Ole; (Germantown,
TN) ; ANDERSON; Kent M.; (Memphis, TN) |
Correspondence
Address: |
HESLIN ROTHENBERG FARLEY & MESITI P.C.
5 COLUMBIA CIRCLE
ALBANY
NY
12203
US
|
Assignee: |
WARSAW ORTHOPEDIC, INC.
Warsaw
IN
|
Family ID: |
38917444 |
Appl. No.: |
11/470810 |
Filed: |
September 7, 2006 |
Current U.S.
Class: |
606/1 |
Current CPC
Class: |
A61B 17/7062 20130101;
A61B 17/707 20130101; A61B 2017/00867 20130101; A61B 17/8076
20130101 |
Class at
Publication: |
606/1 |
International
Class: |
A61B 17/00 20060101
A61B017/00 |
Claims
1. An intercostal spacer device for use in correcting a spinal
deformity comprising: a spacer member comprising a first end and a
second end; a first pair of arms extending from the first end of
the spacer member and a second pair of arms extending from the
second end of the spacer member; and wherein the spacer member,
first pair of arms and second pair of arms are sized and configured
to allow for placement of the intercostal spacer device between two
adjacent ribs of a patient to dynamically produce a force for
correcting a spinal deformity of the patient.
2. The intercostal spacer device of claim 1, wherein the first pair
of arms includes a first anterior arm and a first posterior arm,
the first anterior arm and the first posterior arm being
substantially parallel to each other and forming a first channel
therebetween, and wherein the first channel is sized to receive a
first rib of the two adjacent ribs, and wherein the second pair of
arms includes a second anterior arm and a second posterior arm,
with the second anterior arm and the second posterior arm extending
substantially parallel to each other and forming a second channel
therebetween, wherein the second channel is sized to receive a
second rib of the two adjacent ribs of the patient.
3. The intercostal spacer device of claim 2, wherein the first and
second posterior arms are configured for positioning along a
posterior side of the first and second ribs and the first and
second anterior arms are configured for positioning along an
anterior side of the first and second ribs.
4. The intercostal spacer device of claim 1, wherein the spacer
member comprises a central axis extending between the first end and
the second end thereof, with the first pair of arms disposed at the
first end and the second pair of arms disposed at the second end
each being centered about the central axis.
5. The intercostal spacer device of claim 1, wherein at least one
of the first pair of arms and the second pair of arms is offset in
a lateral direction relative to the central axis of the spacer
member, and wherein at least one of the first pair of arms and the
second pair of arms is offset in a medial direction relative to the
central axis of the spacer member.
6. The intercostal spacer device of claim 1, further comprising at
least one additional pair of arms extending from the first end of
the spacer member.
7. The intercostal spacer device of claim 6, wherein the at least
one additional pair of arms disposed at the first end of the spacer
member is offset in the lateral direction relative to the central
axis and the first pair of arms disposed at the first end of the
spacer member is offset in the medial direction relative to the
central axis, and wherein the second pair of arms at the second end
of the spacer member is centered about the central axis.
8. The intercostal spacer device of claim 1, further comprising at
least one connector, wherein the at least one connector is
configured to secure the intercostal spacer device between the
first and second ribs of the patient.
9. The intercostal spacer device of claim 8, wherein the spacer
member includes at least one bore extending therethrough between an
anteriorly oriented side and a posteriorly oriented side of the
spacer member when positioned between the first and second ribs and
the at least one connector extends through the at least one bore
when employed to couple the intercostal spacer device to the first
and second ribs.
10. The intercostal spacer device of claim 8, wherein the first
pair of arms and the second pair of arms each include at least one
bore extending therethrough between an anteriorly oriented side and
a posteriorly oriented side thereof, with the at least one bore
disposed within the first pair of arms extending in a direction
substantially parallel to a direction of the at least one bore
disposed within the second pair of arms, wherein the at least one
connector is multiple connectors, and wherein a first connector of
the multiple connectors extends through the at least one bore in
the first pair of arms and a second connector of the multiple
connectors extends through the at least one bore in the second pair
of arms when employed to couple the intercostal spacer device to
the first and second ribs.
11. The intercostal spacer device of claim 8, wherein the at least
one connector comprises at least one of a tether, cable, wire,
band, screw, lock pin, rivet, staple and press-fit pin.
12. The intercostal spacer device of claim 1, wherein the
intercostal spacer device is fabricated from a flexible
material.
13. The intercostal spacer device of claim 1, wherein the
intercostal spacer device is capable of resisting a compressive
load with a stiffness of about 10 N/mm to about 300 N/mm.
14. An intercostal spacer device for use in correcting a spinal
deformity comprising: a flexible container for containing an
injectable material, the flexible container being substantially
impermeable to the injectable material and being compressible
following implantation between two adjacent ribs of a patient; a
conduit coupled to the flexible container for injecting the
injectable material into the flexible container; a structure for at
least part of the flexible container; and wherein the structure
controls at least part of a shape of the intercostal spacer device,
and wherein the structure is sized and configured for placement of
the intercostal spacer device between two adjacent ribs of a
patient to produce a force for correcting a spinal deformity of the
patient.
15. The intercostal spacer device of claim 14, wherein the
injectable material is flowable during filling of the flexible
container.
16. The intercostal spacer device of claim 14, wherein the conduit
comprises a one-way valve.
17. The intercostal spacer device of claim 14, wherein the flexible
container is situated inside the structure.
18. The intercostal spacer device of claim 14, wherein the flexible
container is situated outside the structure.
19. The intercostal spacer device of claim 14, wherein the flexible
container is integral with the structure.
20. The intercostal spacer device of claim 14, wherein the
structure comprises a shape memory alloy.
21. The intercostal spacer device of claim 20, wherein the shape
memory alloy is body temperature activated.
22. The intercostal spacer device of claim 20, wherein the shape
memory alloy is elastic.
23. The intercostal spacer device of claim 20, wherein the shape
memory alloy is coupled to an inside of the structure.
24. The intercostal spacer device of claim 20, wherein the shape
memory alloy is coupled to an outside of the structure.
25. The intercostal spacer device of claim 24, wherein the
structure comprises a plurality of interlocking links, and wherein
the plurality of interlocking links comprise the shape memory
alloy.
26. The intercostal spacer device of claim 20, wherein the
structure comprises a structural mesh, and wherein the shape memory
alloy comprises at least one shape memory alloy wire within the
structural mesh.
27. The intercostal spacer device of claim 14, wherein the
structure has at least a partially preformed shape.
28. The intercostal spacer device of claim 14, wherein the
container and the structure together comprise a layer of rubber
thick enough to roughly maintain a desired shape.
29. The intercostal spacer device of claim 14, wherein the
container comprises at least one of silicone, rubber, polyurethane,
polyethylene terephthalate (PET), polyolefin, polycarbonate
urethane, and silicone copolymer.
30. The intercostal spacer device of claim 14, wherein the
injectable material comprises at least one of a curable polymer and
an adhesive.
31. The intercostal spacer device of claim 14, wherein the
structure comprises at least one of PET fabric, polypropylene
fabric, polyethylene fabric and metal wire.
32. The intercostal spacer device of claim 14, wherein the
intercostal spacer device is capable of resisting a compressive
load with a stiffness of about 10 N/mm to about 300 N/mm.
33. The intercostal spacer device of claim 14, wherein the
structure is at least partially permeable.
34. A method of controlling at least part of a shape of an
intercostal spacer device, the intercostal spacer device comprising
a flexible container for containing an injectable material, the
container being substantially impermeable to the injectable
material, and a structure for at least part of the flexible
container, the method comprising creating the structure with at
least one material for controlling at least part of a shape of the
intercostal spacer device with the intercostal spacer device being
sized and configured for placement between two adjacent ribs of a
patient to dynamically produce a force for correcting a spinal
deformity of the patient, and with the flexible container being
compressible following implantation between the two adjacent ribs
of the patient.
35. The method of claim 34, wherein the creating comprises adding a
shape memory alloy to the structure.
36. The method of claim 35, wherein the structure comprises a
structural mesh, and wherein the creating comprises adding at least
one shape-memory alloy wire to the structural mesh.
37. The method of claim 35, wherein the creating comprises coupling
the at least one shape memory alloy to the structure.
38. The method of claim 34, wherein the creating comprises adding a
layer of rubber thick enough to roughly maintain a desired
shape.
39. An intercostal spacer system, the intercostal spacer system
comprising: a plurality of intercostal spacer devices, the
plurality of intercostal spacers including: a first intercostal
spacer device comprising a spacer member including a first end and
a second end, and a first pair of arms extending from the first end
and a second pair of arms extending from the second end, wherein
the spacer member, first pair of arms and second pair of arms of
the first intercostal spacer device are sized and configured for
placement between a first rib and an adjacent second rib of a
patient; a second intercostal spacer device, comprising a spacer
member including a first end and a second end, and a first pair of
arms extending from the first end and a second pair of arms
extending from the second end, wherein the spacer member, first
pair of arms and second pair of arms of the second intercostal
spacer device are sized and configured for placement between
adjacent second rib and a third rib of the patient; and wherein the
first intercostal spacer and the second intercostal spacer
cooperate to dynamically produce a force for correcting a spinal
deformity of the patient.
40. The intercostal spacer system of claim 39, wherein for each of
the intercostal spacer devices, the first pair of arms includes a
first anterior arm and a first posterior arm, with the first
anterior arm and the first posterior arm being substantially
parallel to each other and forming a first channel therebetween,
and wherein the first channel is sized to receive a first rib of
the patient, and wherein the second pair of arms includes a second
anterior arm and a second posterior arm, with the second anterior
arm and the second posterior arm extending substantially parallel
to each other and forming a second channel therebetween, wherein
the channel is sized to receive an adjacent second rib of the
patient.
41. The intercostal spacer system of claim 40, wherein for each of
the intercostal spacer devices, the first and second posterior arms
of the first pair of arms and the second pair of arms are each
positionable along a posterior side of the first and second ribs
and the first and second anterior arms in the first pair of arms
and the second pair of arms is positionable along an anterior side
of the first and second ribs.
42. The intercostal spacer system of claim 39, wherein for each of
the intercostal spacer devices, the spacer member comprises a
central axis extending between the first end and the second end
thereof, with the first pair of arms disposed at the first end and
the second pair of arms disposed at the second end each being
centered about the central axis.
43. The intercostal spacer system of claim 39, wherein the first
intercostal spacer device is positioned between the first rib and
the second rib and the second intercostal spacer device is
positioned between the second rib and the third rib, wherein the
first intercostal spacer device is positioned offset relative to
the second intercostal spacer device.
44. The intercostal spacer system of claim 42, wherein for each of
the intercostal spacer devices, at least one of the first pair of
arms and the second pair of arms is offset in a lateral direction
relative to the central axis of the spacer member, and wherein at
least one of the first pair of arms and the second pair of arms is
offset in a medial direction relative to the central axis of the
spacer member.
45. The intercostal spacer system of claim 44, wherein the first
intercostal spacer device is positioned between the first rib and
the second rib of the patient and the second intercostal spacer
device is positioned between the second rib and the third rib of
the patient, wherein when implanted, the first intercostal spacer
device is positioned for close approximation relative to the second
intercostal spacer device to produce a force for correcting a
spinal deformity of the patient.
46. The intercostal spacer system of claim 39, wherein for each of
the intercostal spacer devices, the intercostal spacer device
further comprising at least one additional pair of arms extending
from the first end of the spacer member.
47. The intercostal spacer system of claim 46, wherein for each of
the intercostal spacer devices, the additional pair of arms
disposed at the first end of the spacer member is offset in the
lateral direction relative to the central axis and the first pair
of arms disposed at the first end of the spacer member is offset in
the medial direction relative to the central axis, and wherein the
second pair of arms extending from the second end of the spacer
member is centered about the central axis.
48. The intercostal spacer system of claim 47, wherein the
plurality intercostal spacer devices are shaped and dimensioned to
allow for close association in use between adjacent ribs of a
patient, wherein the positioning of the plurality of intercostal
spacer devices facilitate the correction of a spinal deformity in
the patient.
49. The intercostal spacer system of claim 39, for each of the
intercostal spacer devices, the intercostal spacer device further
comprises at least one connector, wherein the at least one
connector is configured to secure the intercostal spacer device
between the first and second ribs of the patient.
50. The intercostal spacer system of claim 39, wherein the
intercostal spacer system further comprising at least one
connector, wherein the at least one connector is configured to
couple each of the plurality of intercostal spacer devices
together.
51. The intercostal spacer system of claim 49, wherein for each of
the intercostal spacer devices, the spacer member includes at least
one bore extending therethrough between an anteriorly oriented side
and a posteriorly oriented side of the spacer member when
positioned between the first and second ribs and the at least one
connector extends through the at least one bore when employed to
couple the intercostal spacer device to the first and second
ribs.
52. The intercostal spacer system of claim 49, wherein for each of
the intercostal spacer devices, the first pair of arms and the
second pair of arms each include at least one bore extending
therethrough between an anteriorly oriented side and a posteriorly
oriented side thereof, with the at least one bore disposed within
the first pair of arms extending in a direction substantially
parallel to a direction of the at least one bore disposed within
the second pair of arms, wherein the at least one connector is
multiple connectors, and wherein a first connector of the multiple
connectors extends through the at least one bore in the first pair
of arms and a second connector of the multiple connectors extends
through the at least one bore in the second pair of arms when
employed to couple the intercostal spacer device to the first and
second ribs.
53. The intercostal spacer system of claim 49, wherein for each of
the intercostal spacer devices, the at least one connector
comprises at least one of a tether, cable, wire, band, screw, lock
pin, rivet, staple and press-fit pin.
54. The intercostal spacer system of claim 39, wherein for each of
the intercostal spacer devices, the intercostal spacer device is
fabricated from a flexible material.
55. The intercostal spacer system of claim 39, wherein each of the
intercostal spacer devices are capable of resisting a compressive
load with a stiffness of about 10 N/mm to about 300 N/mm.
56. A method for correcting a spinal deformity, the method
comprising: providing at least one intercostal spacer device
comprising a spacer member having a first end and a second end, and
at least one first pair of arms extending from the first end and a
second pair of arms extending from the second end, wherein the
spacer member, the at least one first pair of arms and the second
pair of arms of the at least one intercostal spacer device are
sized and configured for placement between a first rib and an
adjacent second rib of a patient; and positioning the at least one
intercostal spacer device between the first rib and the adjacent
second rib of the patient, with the first rib disposed between the
at least one first pair of arms and the second rib disposed between
the second pair of arms, thereby facilitating securing the at least
one intercostal spacer device between the first rib and adjacent
second rib and producing a force for correcting a spinal deformity
of the patient.
57. A method for correcting a spinal deformity, the method
comprising: providing an intercostal spacer device, the intercostal
spacer device comprising: a flexible container for containing an
injectable material, the flexible container being substantially
impermeable to the injectable material and being compressible
following implantation between two adjacent ribs of a patient; a
conduit coupled to the flexible container for injecting the
injectable material into the flexible container; and a structure
for at least part of the flexible container, the structure has a
shape of the intercostal spacer device, with the intercostal spacer
device being sized and configured for placement between two
adjacent ribs of a patient; implanting the intercostal spacer
device between the two adjacent ribs of the patient; and injecting
the injectable material into the flexible container through the
conduit so that the shape of the structure is achieved, thereby
producing a force for correcting a spinal deformity of the patient.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS/PATENTS
[0001] This application contains subject matter which is related to
the subject matter of the following applications, which are hereby
incorporated herein by reference in their entirety:
[0002] "Surgical Spacer," by Lange et al., U.S. Ser. No.
11/438,940, filed May 23, 2006;
[0003] "Surgical Spacer with Shape Control," by Lange et al., U.S.
Ser. No. 11/438,891, filed May 23, 2006; and
[0004] "Implants and Methods for Inter-Transverse Process Dynamic
Stabilization of a Spinal Segment," by Bruneau et al., U.S. Ser.
No. 11/104,267, filed Apr. 12, 2005.
TECHNICAL FIELD
[0005] The present invention relates generally to orthopaedic
implants used for the correction of spinal deformities, and more
specifically, but not exclusively, concerns apparatuses placed
within the intercostal space of two ribs to allow for deformity
correction or healing of the spinal column.
BACKGROUND OF THE INVENTION
[0006] To secure and treat spinal deformities, including scoliosis,
it is a generally accepted practice to place implants adjacent to
or into the vertebrae to produce loads for correcting an abnormal
curvature of the spine and to maintain appropriate vertebral
support for the healing of the implanted bone fusion material.
[0007] Typical spinal implant systems are implanted through a
posterior approach to the spinal column and utilize a rod as the
support and stabilizing element connected to a series of two or
more bone fasteners that have been inserted into two or more
vertebrae. The connections between these components are then
secured, thereby fixing a supporting construct to multiple levels
in the spinal column.
SUMMARY OF THE INVENTION
[0008] Advancement of the state of orthopaedic implants and the
treatment of pediatric and adolescent scoliosis is believed to be
desirable. The present invention satisfies the need for
improvements to the surgical treatment by providing a more
mechanically efficient intercostal spacer device for implantation
into multiple intercostal spaces of a patient's rib cage. The
intercostal spacer device is a one piece construct fabricated from
a biocompatible material. Alternatively, the intercostal spacer
device may be a multiple piece construct that includes a flexible
container that is fillable in situ to a desired amount, with a
structure for at least part of the container providing shape
control of the intercostal spacer device. An optional conduit
coupled to the container allows for filling of the container, for
example, by injecting a material into the container.
[0009] The present invention provides in one aspect, an intercostal
spacer device. The intercostal spacer device includes a spacer
member that has a superior end and an inferior end. Extending from
both the superior end and inferior end are at least one pair of
arms with a channel defined between each pair of arms. The spacer
member is sized and configured to enable placement of the spacer
member within an intercostal space, with each channel being sized
to receive a rib allowing the intercostal spacer device to resist
dislodgement from the ribs and produce a force for correcting a
spinal deformity.
[0010] The present invention provides in another aspect, an
intercostal spacer device that includes a flexible container for
receiving an injectable material that is compressible following
implantation between two adjacent ribs, wherein the flexible
container is substantially impermeable to the injectable material.
The intercostal spacer device further includes a conduit coupled to
the flexible container for accepting the injectable material, and a
structure for at least part of the flexible container when
containing the material, wherein the structure has a shape to fit
between two adjacent ribs.
[0011] Another aspect of the present invention provides a method of
controlling at least part of the shape of the intercostal spacer
device. The intercostal spacer device has a flexible container for
containing an injectable material that is compressible following
implantation, wherein the container is substantially impermeable to
the injectable material. The intercostal spacer device further
includes a structure for at least part of the flexible container.
The method provides for creating the structure with at least one
material for controlling at least part of the shape of the
intercostal spacer device following implantation into the
intercostal space.
[0012] The present invention provides in yet another aspect, an
intercostal spacer system. The intercostal spacer system includes a
plurality of intercostal spacer devices, with each of the
intercostal spacer devices having a spacer member that has a
superior end and an inferior end. Extending from both the superior
end and inferior end are at least one pair of arms with a channel
being defined between each pair of arms. The spacer member is sized
and configured to enable placement of the member within an
intercostal space, with each channel being sized to receive a rib,
allowing the intercostal spacer device to resist dislodgement from
the ribs when implanted. Following implantation, the plurality of
intercostal spacer devices cooperate to dynamically produce a force
for correcting a spinal deformity within a patient.
[0013] The present invention provides another aspect, a method of
correcting a spinal deformity. The method includes the step of
providing at least one intercostal spacer device, the intercostal
spacer device includes a spacer member having first and second ends
with at least one pair of arms extending from each of the first and
second ends. The spacer member, the first pair of arms extending
from the first end and the second pair of arms extending from the
second end of the at least one intercostal spacer are sized for
placement between a first rib and an adjacent second rib of a
patient. The method further includes the positioning of the at
least one intercostal spacer device into the intercostal space
between the two adjacent ribs of the patient with the first rib
disposed between the first pair of arms and the adjacent second rib
disposed between the second pair of arms and thus securing the
intercostal spacer device within the intercostal space and
producing a force to correct the spinal deformity of the
patient.
[0014] Another aspect of the present invention provides a method of
correcting a spinal deformity. The method includes providing an
intercostal spacer device, the intercostal spacer devices includes
a flexible container for containing an injectable material that is
compressible following implantation, wherein the flexible container
is substantially impermeable to the injectable material. The
intercostal spacer device further includes a conduit coupled to the
flexible container for accepting the injectable material, and a
structure for at least part of the flexible container when
containing the material, wherein the structure has a shape of the
intercostal spacer device that is sized and configured to fit
between adjacent ribs in a patient. The method further includes
implanting the intercostal spacer device between two adjacent ribs.
The injectable material is then injected into the flexible
container through the conduit such that the shape of the structure
is achieved, thus producing a force to correct the spinal deformity
of the patient.
[0015] 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
[0016] 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:
[0017] FIG. 1A is a side elevational view of one embodiment of an
intercostal spacer device shown disposed between the cross-section
of two adjacent ribs, in accordance with an aspect of the present
invention;
[0018] FIG. 1B is a side elevational view of one embodiment of an
intercostal spacer device with two single connectors shown disposed
between the cross-section of two adjacent ribs, in accordance with
an aspect of the present invention;
[0019] FIG. 1C is a side elevational view of one embodiment of an
intercostal spacer device shown disposed between the cross-section
of two adjacent ribs, with a single connector surrounding the
entire intercostal spacer device, in accordance with an aspect of
the present invention;
[0020] FIG. 1D is a side elevational view of one embodiment of an
intercostal spacer device, shown disposed between the cross-section
of two adjacent ribs, with a single connector utilizing an
alternative securing configuration, in accordance with an aspect of
the present invention;
[0021] FIG. 1E is a side elevational view of one embodiment of an
intercostal spacer device shown disposed between the cross-section
of two adjacent ribs, with two alternative single connectors
inserted through two bore holes, in accordance with an aspect of
the present invention;
[0022] FIG. 1F is a perspective view of the intercostal spacer
device embodiment of FIG. 1E with the two alternative single
connectors extracted from the two bore holes, in accordance with an
aspect of the present invention;
[0023] FIG. 2 is a posterior elevational view of one embodiment of
an intercostal spacer system implanted in the posterior aspect of
the rib cage, in accordance with an aspect of the present
invention;
[0024] FIG. 3 is a perspective view of one embodiment of an
intercostal spacer device, in accordance with an aspect of the
present invention;
[0025] FIG. 4A is a posterior elevational view of one embodiment of
an intercostal spacer system shown disposed between three ribs, in
accordance with an aspect of the present invention;
[0026] FIG. 4B is a cross-section side elevational view of the
intercostal spacer device system of FIG. 4A taken along line 4B-4B
shown disposed between the cross-section of four adjacent ribs, in
accordance with an aspect of the present invention;
[0027] FIG. 4C is a posterior perspective view of one embodiment of
an intercostal spacer system shown disposed between four adjacent
ribs, in accordance with an aspect of the present invention;
[0028] FIG. 5 is a perspective view of one embodiment of an
intercostal spacer device, in accordance with an aspect of the
present invention;
[0029] FIG. 6 is a posterior elevational view of one embodiment of
an intercostal spacer system implanted in the posterior aspect of
the rib cage, in accordance with an aspect of the present
invention;
[0030] FIG. 7 is a posterior elevational view of one embodiment of
an intercostal spacer device system shown disposed between four
adjacent ribs, in accordance with an aspect of the present
invention;
[0031] FIG. 8 is a perspective partial cut-away view of one
embodiment of an unfilled intercostal spacer device with the
container in the structure, in accordance with an aspect of the
present invention;
[0032] FIG. 9 is a posterior elevational view of one embodiment of
an intercostal spacer device with an integrated container and
structure, in accordance with an aspect of the present
invention;
[0033] FIG. 10 is a cross-sectional elevational view of one
embodiment of an intercostal spacer device with an external
container, in accordance with an aspect of the present invention;
and
[0034] FIG. 11 depicts another embodiment of an intercostal spacer
device with an integrated container and structure, in accordance
with another aspect of the present invention.
BEST MODE FOR CARRYING OUT THE INVENTION
[0035] As depicted in FIG. 1A, the general arrangement of an
intercostal spacer device 10, in accordance with an aspect of the
present invention, includes a spacer member 11 comprising a
superior end 12 and an inferior end 13 with a central axis (not
shown) extending between superior end 12 and inferior end 13.
Extending in an upward direction from superior end 12 is preferably
one pair of arms 14 that may include an anterior arm 15 and a
posterior arm 16. Further, extending in a downward direction from
inferior end 13 is preferably one pair of arms 17 that may include
an anterior arm 18 and a posterior arm 19. Each pair of arms 14, 17
are integral to spacer member 11 and are sized to resist
dislodgement of intercostal spacer device 10 following placement
within the intercostal space. Further, each pair of arms 14, 17 are
centered about the central axis of spacer member 11 resulting in a
roughly H-shaped overall structure. An upper channel 20 is
typically defined by a seat 22, anterior arm 15 and posterior arm
16. Additionally, a lower channel 21 is defined by a seat 23,
anterior arm 18 and posterior arm 19. Anterior arm 15 and posterior
arm 16 are disposed relatively parallel to each other and project
in an upward manner from seat 22. Anterior arm 18 and posterior arm
19 project in a downward manner from seat 23 and are substantially
parallel to each other. Each pair of arms 14, 17, together with
seats 22, 23 form U-shaped channels 20, 21 respectively, which are
each appropriately sized to receive a rib 30. When in use in the
rib cage, intercostal spacer device 10 is placed within an
intercostal space. Preferably, intercostal spacer device 10 is
maneuvered in a manner allowing two adjacent ribs 30 to be
positioned within channels 20, 21, causing the anterior aspect of
the two adjacent ribs 30 to contact anterior arms 15, 18 and the
posterior aspect of the two adjacent ribs 30 to contact posterior
arms 16, 19.
[0036] With reference to FIGS. 1B, 1C, 1D, 1E and 1F, intercostal
spacer device 10 includes a spacer member 11 comprising a superior
end 12 and an inferior end 13. Extending in an upward direction
from superior end 12 is preferably one pair of arms 14 that may
include an anterior arm 15 and a posterior arm 16. Further,
extending in a downward direction from inferior end 13 is
preferably one pair of arms 17 that may include an anterior arm 18
and a posterior arm 19. An upper channel 20 is typically defined by
a seat 22, anterior arm 15 and posterior arm 16. Additionally, a
lower channel 21 is defined by a seat 23, anterior arm 18 and
posterior arm 19. Each pair of arms 14, 17 together with seats 22,
23 form U-shaped channels 20, 21 respectively, which are each
appropriately sized to receive a rib 30. Typically, at least one
through hole 24 is directed in the anterior to posterior direction
and located within spacer member 11 in the intercostal spacer
device 10. In one approach, connector 40 (see FIG. 1B) is inserted
into hole 24 following the placement of intercostal spacer device
10 between adjacent ribs 30. As depicted in FIG. 1B, a first
connector 40 may be inserted through passage or hole 24 that
extends from an anterior surface 31 of spacer member 11 to a
posterior surface 32 of spacer member and then wraps over the
superior surface of rib 30 which is positioned within upper channel
20. A second connector 40 may be inserted through a second passage
or hole 24 that extends from anterior surface 31 of spacer member
11 to posterior surface 32 of spacer member 11 and then wraps over
the inferior surface of a second adjacent rib 30 which is
positioned within lower channel 21. The ends of connectors 40 may
be secured using crimps, knots, ties or other suitable fasteners.
It is understood to those skilled in the art that other securement
techniques and configurations are contemplated and will depend on
the type of connector 40 used within intercostal spacer device
10.
[0037] As shown in FIG. 1C, an alternative method of securing
intercostal spacer device 10 within the intercostal space may
include extending at least one connector 40 around the
circumference of the exterior surface of intercostal spacer device
10 and the two adjacent ribs 30. The ends of connector 40 may be
then be secured using crimps, knots, ties or other suitable
fasteners, although it is understood to those skilled in the art
that other securement techniques and configurations are
contemplated and will depend on the type of connector 40 used in
securing intercostal spacer device 10 within the intercostal
space.
[0038] As seen in FIG. 1D, another alternative method of securing
intercostal spacer device 10 within the intercostal space is
contemplated. FIG. 1D depicts the use of at least one connector 40
typically utilizing a figure-8 configuration. A single or multiple
connector 40 may be inserted through an angled passage or hole 25
that extends from anterior surface 31 of spacer member 11 to
posterior surface 32 of spacer member 11 and then looped over the
superior surface of rib 30 which is positioned within upper channel
20. Connector 40 is further passed through a second angled passage
or hole 25 that extends from anterior surface 31 of spacer member
11 to posterior surface 32 of spacer member allowing connector 40
to also loop over the inferior surface of a second adjacent rib 30
which is positioned within lower channel 21. The two ends of
connector 40 may be secured using crimps, knots, ties or other
suitable fastener. It is understood to those skilled in the art
that other securement techniques and configurations are
contemplated and will depend on the type of connector 40 used
within intercostal spacer device 10. Connector 40 may be in the
form of a wire, cable, tether, belt, band, cord or other suitable
structure for securement within the intercostal space and may be
fabricated from a material selected from the group consisting of
carbon fiber composite polymers, bio-compatible metals, resorbable
polymers, bio-inert polymeric materials, and any combinations of
these materials.
[0039] Another alternative method for securing intercostal spacer
device 10 within the intercostal space is seen at FIGS. 1E and 1F.
As shown, intercostal spacer device 10 includes a spacer member 11
comprising a superior end 12 and an inferior end 13. Extending in
an upward direction from superior end 12 is preferably one pair of
arms 14, including anterior arm 15 and posterior arm 16. Further,
extending in a downward direction from inferior end 13 is
preferably one pair of arms 17 that may include anterior arm 18 and
posterior arm 19. As provided above, upper channel 20 is typically
defined by seat 22, anterior arm 15 and posterior arm 16.
Additionally, lower channel 21 is defined by seat 23, anterior arm
18 and posterior arm 19. Each pair of arms 14, 17 together with
seats 22, 23 form U-shaped channels 20, 21 respectively, which are
each appropriately sized to receive a rib 30. Preferably, at least
one through hole 26 is directed in an anterior to posterior
direction and passes through anterior arms 15, 18 and posterior
arms 16, 19 located within superior pair of arms 14 and inferior
pair of arms 17, respectively. As seen in FIG. 1E, at least one
hole 26 extends through superior pair of arms 14 and is
substantially parallel to a second hole 26 extending through
inferior pair of arms 17. In use, intercostal spacer device 10 is
placed within an intercostal space and typically is maneuvered in a
manner to allow two adjacent ribs 30 to be positioned within upper
and lower channels 20, 21, causing the anterior aspect of two
adjacent ribs 30 to contact anterior arms 15, 18 and the posterior
aspect of two adjacent ribs 30 to contact posterior arms 16, 19.
Following final placement of intercostal spacer device 10, a
connector 41 (see FIG. 1F) is inserted into hole 26 following the
placement of intercostal spacer device 10 between adjacent ribs 30.
As depicted in FIG. 1E, one connector 41 may be inserted through
hole 26 that is located in the most upper portion of superior pair
of arms 14 and span upper channel 20 and across the superior margin
of rib 30. Preferably, a second connector 41 is inserted through a
second hole 26 located in the most downward portion of inferior set
of arms 17 and span lower channel 21 and across the inferior margin
of rib 30. The ends of the two connectors 41 may be secured using
crimps, caps, nuts, rivets, or other suitable fastener device. It
is understood to those skilled in the art that other securement
techniques and configurations are contemplated and will depend on
the type of connector 41 used within intercostal spacer device 10.
Connector 41 may be in the form of a bolt, screw, lock pin, rivet,
staple, press-fit pin or other suitable structure for securement
within the intercostal space and may be fabricated from a material
selected from the group consisting of carbon fiber composite
polymers, bio-compatible metals, resorbable polymers, bio-inert
polymeric materials, and any combinations of these materials.
[0040] FIG. 2 depicts an intercostal spacer system that includes a
plurality of intercostal spacer devices 10 placed within the rib
cage to correct a spinal deformity of a patient. Multiple
intercostal spacer devices 10 are inserted into the intercostal
spaces of several adjacent ribs 30 at corresponding deformed spinal
levels. Adjacent intercostal spacer devices 10 are preferably
implanted in an offset manner relative to each other, resulting in
an overall generally staggered arrangement. As described
previously, each of the plurality of intercostal spacer devices 10
may be secured within the intercostal space with at least one
connector 40, 41 (not shown). Alternatively, at least one connector
40 may link or couple each of the plurality of intercostal spacer
devices 10 to each other (not shown). Typically, the number of
intercostal spacer devices 10 implanted may be dependent upon the
severity of the spinal deformity and the affected levels of the
spinal column. By way of example only, in FIG. 2, three intercostal
spacer devices 10 are placed on the concave side of a
medial-lateral deformity that spans four levels of the spinal
column.
[0041] FIG. 3 depicts an alternative embodiment of an intercostal
spacer device 100. Intercostal spacer device 100 includes a spacer
member 110 comprising of a superior end 112 and an inferior end 113
with a central axis (not shown) extending between superior end 112
and inferior end 113. Extending in an upward direction from
superior end 112 is preferably two pair of arms 114, with each pair
of arms including an anterior arm 115 and a posterior arm 116.
Further, extending from inferior end 113 in a downward direction is
preferably one pair of arms 117 that may include an anterior arm
118 and a posterior arm 119. Each pair of arms 114, 117 are
integral to spacer member 110 usually with one of the two superior
pair of arms 114 being offset laterally relative to the central
axis and the second of the two superior pair of arms 114 being
offset medially relative to the central axis. The inferior pair of
arms 117 are preferably centered about the central axis resulting
in a roughly Y-shaped overall structure defining intercostal spacer
device 100. For each of superior pair of arms 114, an upper channel
120 is typically defined by a seat 122, anterior arm 115 and
posterior arm 116. Additionally, for inferior pair of arms 117, a
lower channel 121 is defined by a seat 123, anterior arm 118 and
posterior arm 119. For both superior pair of arms 114, anterior arm
115 and posterior arm 116 are disposed relatively parallel to each
other and project in a generally upward manner from seat 122. For
inferior pair of arms 117, anterior arm 118 and posterior arm 119
project in a generally downward manner from seat 123 and are
substantially parallel to each other. Each pair of arms 114, 117,
together with seats 122, 123 form U-shaped channels 120, 121
respectively, which are each appropriately sized to receive a rib
30 and allow intercostal spacer device 100 to resist dislodgement
following implantation within the rib cage.
[0042] Although not shown, it is contemplated that either connector
40, 41 may be utilized with intercostal spacer device 100 to secure
intercostal spacer device 100 within an intercostal space. As
described above, it is contemplated that connector 40 may pass
through anterior to posterior directed, single or multiple,
straight or angled holes or passages (not shown) within spacer
member 110, thereby allowing connector 40 to wrap or loop around or
over both superior pair of arms 114 and inferior pair of arms 117
allowing for securement of intercostal spacer device 100 within the
intercostal space in the same or similar manner as described above
for intercostal spacer device 10. Further, as discussed above, it
is understood that connector 41 may be inserted through anterior to
posterior directed, single or multiple straight holes or passages
(not shown) within both superior pair of arms 114 and inferior pair
of arms 117. The holes located in both superior pair of arms 114
being substantially parallel to the hole or passage located in
inferior pair of arms 117. When in use, connector 41 preferably
will be inserted through the holes that are located in the upper
most portion of both superior pair of arms 114 and span each upper
channel 120 and across the superior margin of rib 30. Additionally,
a second connector 41 may be inserted through a hole or passage
located in the downward most portion of inferior set of arms 117
and span lower channel 121 crossing over the inferior margin of rib
30.
[0043] As shown in FIGS. 4A, 4B and 4C, when used in the rib cage,
intercostal spacer device 100 is typically placed within an
intercostal space. Preferably, intercostal spacer device 100 is
maneuvered in a manner allowing two adjacent ribs 30 to be
positioned within two upper channels 120 and lower channel 121,
causing the anterior aspect of two adjacent ribs 30 to contact
anterior arms 115, 118 and the posterior aspect of two adjacent
ribs 30 to contact posterior arms 116, 119.
[0044] FIGS. 4A and 4B further depict an alternative embodiment of
an intercostal spacer system that includes a plurality of
intercostal spacer devices 100 in use within the rib cage to
correct a spinal deformity of a patient. Multiple intercostal
spacer devices 100 are inserted into the intercostal spaces of
adjacent ribs 30 at corresponding affected spinal levels. Adjacent
intercostal spacer devices 100 are preferably implanted in close
association relative to each other, resulting in an overall
generally linear arrangement of the system as shown in FIG. 4A.
Preferably, when implanted, the shape and size of intercostal
spacer device 100 allows for inferior pair of arms 117 of an upper
placed intercostal spacer device 100 to be positioned proximate or
within the space defined between the two superior pair of arms 114
of an adjacent lower placed intercostal spacer device 100. As
described previously, each of the plurality of intercostal spacer
devices 100 may be secured within the intercostal space with at
least one connector 40, 41 (not shown). Alternatively, at least one
connector 40 may link or couple each of the plurality of
intercostal spacer devices 100 to each other (not shown).
Typically, the number of intercostal spacer devices 100 implanted
is dependent upon the severity of the spinal deformity and the
affected levels of the spinal column. By way of example only, in
FIG. 4C, three intercostal spacer devices 100 are shown to be used
to correct a spinal deformity that spans four levels of the spinal
column.
[0045] FIG. 5 depicts still another alternative embodiment of an
intercostal spacer device 200. Intercostal spacer device 200
includes a spacer member 210 comprising a superior end 212 and an
inferior end 213 with a central axis (not shown) extending between
superior end 212 and inferior end 213. Extending in an upward
direction from superior end 212 is preferably one pair of arms 214
including an anterior arm 215 and a posterior arm 216. Further,
extending in a downward direction from inferior end 213 is
preferably one pair of arms 217 that may include an anterior arm
218 and a posterior arm 219. Each pair of arms 214, 217 are
integral to spacer member 210 usually with superior pair of arms
214 being offset laterally relative to the central axis and
inferior pair of arms 217 being preferably offset medially relative
to the central axis. It is contemplated, that an alternative
configuration of intercostal spacer device 200 may include each
pair of arms 214, 217 to be opposite as described previously, in
that superior pair of arms 214 being offset medially relative to
the central axis and inferior pair of arms 217 being offset
laterally relative to the central axis. An upper channel 220 is
typically defined by a seat 222, anterior arm 215 and posterior arm
216. Additionally, for inferior pair of arms 217, a lower channel
221 is defined by a seat 223, anterior arm 218 and posterior arm
219. Anterior arm 215 and posterior arm 216 are disposed relatively
parallel to each other and project in a generally upward direction
from seat 222. Inferior pair of arms 217, anterior arm 218 and
posterior arm 219 project in a generally downward direction from
seat 223 and are substantially parallel to each other. Each pair of
arms 214, 217, together with seats 222, 223 form U-shaped channels
220, 221 respectively, which are each appropriately sized to
receive a rib 30.
[0046] Although not shown, as discussed above, it is contemplated
that either connector 40, 41 may be utilized with intercostal
spacer device 200 to secure intercostal spacer device 200 within an
intercostal space. As described previously, it is contemplated that
connector 40 may be positioned through anterior to posterior
directed, single or multiple, straight or angled holes (not shown)
within spacer member 210, thereby allowing connector 40 to wrap or
loop around or over superior pair of arms 214 and inferior pair of
arms 217 allowing for securement of intercostal spacer device 200
within the intercostal space in the same or similar manner as
described for intercostal spacer device 10. Further, as discussed
above, it is understood that connector 41 may be inserted through
anterior to posterior directed, single or multiple straight holes
or passages (not shown) within superior pair of arms 214 and
inferior pair of arms 217. The hole or passage located in superior
pair of arms 214 being substantially parallel to the hole located
in inferior pair of arms 217. When in use, connector 41 preferably
will be inserted through the hole or passage that is located in the
upper most portion of superior pair of arms 214 and span upper
channel 220 and across the superior margin of rib 30. Additionally,
a second connector 41 may be inserted through a hole or passage
located in the downward most portion of inferior set of arms 217
and span lower channel 221 and across the inferior margin of rib
30.
[0047] As shown in FIGS. 6 and 7, when used in the rib cage,
intercostal spacer device 200 is placed within an intercostal
space. Preferably, intercostal spacer device 200 is maneuvered in a
manner allowing two adjacent ribs 30 to be positioned within each
of the upper channel 220 and lower channel 221, causing the
anterior aspect of two adjacent ribs 30 to contact anterior arms
215, 218 and the posterior aspect of two adjacent ribs 30 to
contact posterior arms 216, 219. Upper channel 220 and lower
channel 221 are sized and configured to provide resistance to any
in vivo forces that may dislodge intercostal spacer device 200 from
its position within the intercostal space.
[0048] FIGS. 6 and 7 further depict an alternative embodiment of an
intercostal spacer system which includes a plurality of intercostal
spacer devices 200 in use within the rib cage to correct a spinal
deformity of a patient. Multiple intercostal spacer devices 200 are
inserted into the intercostal spaces of adjacent ribs 30 at
corresponding affected spinal levels. Adjacent intercostal spacer
devices 200 are preferably implanted in close approximation
relative to each other, resulting in an overall generally linear
arrangement of the system. Preferably, when implanted, the shape
and size of intercostal spacer device 200 allows for inferior pair
of arms 217 of an upper intercostal spacer device 200 to either
contact or be proximate to spacer member 210 of the adjacent and
lower intercostal spacer device 200. Additionally, when implanted,
typically, superior pair of arms 214 of lower intercostal spacer
device 200 will contact or be in close approximation to spacer
member 210 of adjacent upper intercostal spacer device 200. As
shown in FIG. 7, following implantation, rib 30 may be
simultaneously located within lower channel 221 of a superior
placed intercostal spacer device 200 and upper channel 220 of an
inferior placed intercostal spacer device 200. As described
previously, each of the plurality of intercostal spacer devices 200
may be secured within the intercostal space with at least one
connector 40, 41 (not shown). Alternatively, at least one connector
40 may link or couple each of the plurality of intercostal spacer
devices 200 to each other (not shown). Usually, the number of
intercostal spacer devices 200 implanted is dependent upon the
severity of the spinal deformity and the affected levels of the
spinal column. By way of example only, in FIG. 6, three intercostal
spacer devices 200 are used to correct a spinal deformity that
spans four levels of the spinal column.
[0049] With respect to the various embodiments of the intercostal
spacer device 10, 100, 200 described herein, the intercostal spacer
device 10, 100, 200 can be fabricated from materials that are
flexible or exhibit at least some flexibility. Additionally, the
intercostal spacer device 10, 100, 200 may be fabricated from
materials that are resilient and/or elastic, so it can assume
various shapes during and after insertion and securement within the
intercostal space.
[0050] The intercostal spacer device 10, 100, 200 can be made from
any biocompatible material, material of synthetic or natural
origin, and material of a resorbable or non-resorbable nature.
Suitable examples of construct material include resorbable
materials including polylactide, polyglycolide, tyrosine-derived
polycarbonate, polyanhydride, polyorthoester, polyphosphazene,
calcium phosphate, hydroxyapatite, bioactive glass, collagen,
albumin, fibrinogen and combinations thereof; and non-resorbable
materials including polyethylene, polyester, polyvinyl alcohol,
polyacrylonitrile, polyamide, polytetrafluorethylene,
poly-paraphenylene terephthalamide, polyetheretherketone, poly
urethane, and combinations thereof. Further non-resorbable
materials may include carbon-reinforced polymer composites,
shape-memory alloys, titanium, titanium alloys, cobalt chrome
alloys, stainless steel, and combinations thereof. The intercostal
spacer device 10, 100, 200 is preferably fabricated from material
capable of resisting compressive motion (or loads) with a stiffness
of about 10 to about 300 N/mm (newtons per millimeter).
[0051] The method for correcting a spinal deformity includes,
providing at least one intercostal spacer device 10, intercostal
spacer device 10 includes spacer member 11 comprising superior end
12 and inferior end 13 with a central axis (not shown) extending
between superior end 12 and inferior end 13. Extending outward from
superior end 12 is preferably at least one superior pair of arms 14
that may include anterior arm 15 and posterior arm 16. Further,
extending outward from inferior end 13 is preferably one superior
pair of arms 17 that may include anterior arm 18 and posterior arm
19. Each pair of arms 14, 17 are integral to spacer member 11. An
upper channel 20 is typically defined by seat 22, anterior arm 15
and posterior arm 16. Additionally, a lower channel 21 is defined
by seat 23, anterior arm 18 and posterior arm 19. Each pair of arms
14, 17, together with seats 22, 23 form U-shaped channels 20, 21
which are each appropriately sized to receive a rib 30. The method
further includes preferably positioning intercostal spacer device
10 within the intercostal space between two adjacent ribs 30.
Preferably, the intercostal spacer device 10 is maneuvered in a
manner that typically results in the positioning of a first rib 30
into upper channel 20 between superior pair of arms 14 and a second
rib 30 into lower channel 21 between inferior pair of arms 17.
Placement of ribs 30 within upper and lower channels 20, 21 secures
intercostal spacer device 10 within the patient's rib cage and
produces a compressive or distraction force, depending on the
spinal curvature geometry, for correcting a spinal deformity. It is
further understood that the method may include inserting connectors
40, 41 into each of the intercostal spacer devices 10 following
implantation into the intercostal space. Preferably, at least one
connector 40 may be utilized with each individual intercostal
spacer device 10 or alternatively, at least one connector 40 may
link or couple the plurality of intercostal spacer devices to each
other. It is contemplated herein that the steps of the method for
connecting a spinal deformity are analogous to those that may be
used with intercostal spacer device 100 and intercostal spacer
device 200 described herein.
[0052] FIGS. 8, 9, 10 and 11 show a further alternative embodiment
of the intercostal spacer device 400 that can be formed in situ
during a surgical procedure. Intercostal spacer device 400 includes
the following basic aspects: a flexible container 402 and a
structure 404 for at least part of flexible container 402 that
controls at least part of the shape of intercostal spacer device
400. Flexible container 402 can be filled or injected through
optional conduit 406 after placement. Further, structure 404 may be
folded or otherwise reduced in size prior to use in some aspects.
Together with an unfilled container 402, in some aspects,
intercostal spacer device 400 can create a smaller footprint during
implantation. Once filled, structure 404 provides support and
containment for the flexible container 402, as well as providing
shape control for at least part of intercostal spacer device
400.
[0053] FIG. 8 depicts a partially cut-away view of intercostal
spacer device 400. As shown in FIG. 8, intercostal spacer device
400 comprises an unfilled flexible container 402 inside structure
404. Preferably, flexible container 402 is in an evacuated state
during implantation and prior to being filled. Where a valve (e.g.,
a one-way valve) is coupled to flexible container 402, with
flexible container 402 preferably being evacuated prior to or
during the process of coupling the valve thereto. In this
embodiment, structure 404 is outside flexible container 402.
However, as will be described in more detail below, flexible
container 402 can be outside structure 404, or flexible container
402 and structure 404 can be integrated. In addition, although
structure 404 is shown to be roughly H-shaped to fit between
adjacent ribs 30, structure 404 may have any shape necessary for
the particular surgical application. For example, structure 404
could instead have a roughly cylindrical shape to replace an
intervertebral disc. As another example, structure 404 could be
spherically or elliptically shaped to replace part of the
intervertebral disc, for example, the nucleus pulpous, leaving the
rest of the disc intact. Further, although structure 404 is shown
enveloping the flexible container 402, structure 404 could be for
only a portion of flexible container 402, depending on the
particular application. For example, it may be desired to prevent
bulging of flexible container 402 only in a particular area.
Coupled to flexible container 402 is optional conduit 406 for
accepting a material that is compressible following implantation.
Structure 404 provides support for and containment of flexible
container 402, when filled.
[0054] Flexible container 402 is flexible and substantially
impermeable to the material it will be filled with. However,
depending on the application, flexible container 402 may be
permeable to other materials, for example, it may be air and/or
water permeable. In the present example, flexible container 402
takes the form of a bag or balloon, but can take other forms, so
long as flexible and substantially impermeable to the material it
will be filled with. Thus, flexible container 402 must be
substantially impermeable to the injectable material, for example,
in a liquid state during filling and prior to curing. Examples of
container materials include silicone, rubber, polyurethane,
polyethylene terephthalate (PET), polyolefin, polycarbonate
urethane, and silicone copolymers.
[0055] Conduit 406 accepts the injectable material being used to
fill flexible container 402. Preferably, conduit 406 comprises a
one-way valve, however, a two-way valve is also contemplated, as
another example. Conduit 406 can comprise any material suitable for
implanting, for example, various plastics. Also preferably, conduit
406 is constructed to be used with a delivery system for filling
flexible container 402, such as, for example, a pressurized
syringe-type delivery system. However, the delivery system itself
forms no part of the present invention. It is contemplated that,
conduit 406 may be optional. Other examples of how to fill flexible
container 402 comprise the use of a self-sealing material for
flexible container 402, or leaving an opening in flexible container
402 that is closed (e.g., sewn shut) intraoperatively after
filling. Using a curable material to fill flexible container 402
may also serve to self-seal flexible container 402.
[0056] In use, flexible container 402 is filled with an injectable
material that is compressible following implantation between two
adjacent ribs of a patient. The compressibility characteristic
ensures that the injected material exhibits viscoelastic behavior
and that, along with structure 404, the intercostal spacer device
400 can accept compressive loads. Preferably, intercostal spacer
device 400 may be capable of resisting compressive motion (or
loads) with a stiffness of about 10 to about 300 N/mm (newtons per
millimeter). The material is preferably injectable, and may be
compressible immediately or after a time, for example, after
curing. For purposes of the invention, the compressibility
characteristic is necessary during end use, i.e., after
implantation. Materials that could be used include, for example, a
plurality of beads (e.g., polymer beads) that in the aggregate are
compressible, or materials that change state from exhibiting fluid
properties to exhibiting properties of a solid or semi-solid.
Examples of such state-changing materials include two-part curing
polymers and adhesive, for example, platinum-catalyzed silicone,
epoxy or polyurethane.
[0057] As noted above, structure 404 provides support for and
containment of container 402 when filled, as well as at least
partial shape control of intercostal spacer device 400. Structure
404 comprises, for example, a structural mesh comprising a
plurality of fibers and/or wires 408. Within the structural mesh
are shape-control fibers and/or wires 410. In one example, shape
control is provided by wires of a shape-memory alloy (e.g.,
Nitinol). Shape-memory alloy wire(s) 410 can be coupled to the
structural mesh (inside or outside), or weaved into the mesh (i.e.,
integrated). Coupling can be achieved, for example, by stitching,
twisting, or closing the wire on itself. Alternatively, shape
control can be provided by other wires or fibers that do not "give"
in a particular direction, for example, metal or metal alloys
(e.g., tantalum, titanium or steel, and non-metals, for example,
carbon fiber, PET, polyethylene, polypropylene, etc.). The
shape-memory alloy can be passive (e.g., elastic) or active (e.g.,
body-temperature activated). The use of metal, metal alloy or
barium coated wires or fibers can also improve radiopacity for
imaging. The remainder of structure 404 can take the form of, for
example, a fabric jacket, as shown in FIG. 8. Although the
shape-memory alloy wires 410 make up only a portion of the
structural mesh of FIG. 8, it will be understood that there could
be more such wires, up to and including comprising the entirety of
the mesh. The fabric jacket in this example contains and helps
protect flexible container 402 from bulging and damage from forces
external to flexible container 402, while the shape-memory alloy
provides shape control of intercostal spacer device 400 in a center
region 412. The fibers of the jacket comprise, for example, PET
fabric, polypropylene fabric, polyethylene fabric and/or steel,
titanium or other metal wire. Depending on the application,
structure 404 may be permeable to a desired degree. For example, if
bone or tissue growth is desired to attach to structure 404,
permeability to the tissue or bone of interest would be
appropriate. As another example, permeability of structure 404 may
be desired to allow the material used to fill flexible container
402 to evacuate air or water, for example, from flexible container
402, in order to prevent bubbles from forming inside. Where a mesh
is used, for example, the degree of permeability desired can be
achieved by loosening or tightening the weave.
[0058] Although structure 404 is shown in a roughly H-shape in the
example of FIG. 8, it will be understood that in practice,
structure 404 can be made to be folded, unexpanded, or otherwise
compacted. This is particularly true where, for example, structure
404 comprises a fabric or other easily folded material. A folded or
unexpanded state facilitates implantation, allowing for a smaller
surgical opening, and unfolding or expansion in situ upon filling
of flexible container 402. Further, structure 404 can have a
different final shape, depending on the shape-control material
used. For example, the shape-memory wires in FIG. 8 may be in their
inactive state, whereupon activation by body temperature causes
contraction thereof, making the spacer of FIG. 8 "thinner" than
shown in center region 412.
[0059] FIG. 9 depicts an outer view of another example of an
intercostal spacer device 500 in accordance with an aspect of the
present invention. A flexible container conduit 501 is shown
pointing outward from an opening 503. As shown, the structure 502
delimits the final shape of intercostal spacer device 500.
Structure 502 comprises a mesh 504 of shape-memory alloy wire, that
is soaked through with a dispersion polymer 506 (e.g., silicone).
The dispersion polymer (after curing) acts as the flexible
container and is shown filled in FIG. 9. This is one example of the
flexible container and structure 502 being integral. Although mesh
504 of FIG. 9 is described as being all shape-memory alloy wire, it
will be understood that, like FIG. 8, the shape-memory alloy could
only form a part of structure 502.
[0060] FIG. 10 is a cross-sectional view of another example of an
intercostal spacer device 600 in accordance with the present
invention. Intercostal spacer device 600 is similar to intercostal
spacer device 500 of FIG. 9, except that instead of being soaked in
a dispersion polymer, a structural mesh 602 of a shape-memory alloy
wire is coated with a dispersion polymer (e.g., silicone) 604 or
other curable liquid appropriate for the container material,
creating an outer flexible container. The coating can be done in a
conventional manner, for example, by dip molding on the outside of
the mesh.
[0061] FIG. 11 depicts yet another example of an intercostal spacer
device 800 with an integrated flexible container and structure, in
accordance with another aspect of the present invention. The
flexible container and structure in the example of FIG. 11 both
comprise a single layer 802 of rubber that is thick enough for a
given application to perform the functions of both the flexible
container and structure (including shape control). Such a rubber
shell would be able to return to its original shape when
unconstrained. In addition, intercostal spacer device 800
preferably includes a conduit 804 (preferably, a one-way valve) for
filling the internal space 806. The injectable material can be any
of the filling materials described above, for example,
silicone.
[0062] In an alternate aspect, the rubber shell 802 of FIG. 11 can
be augmented with internal, external, or integrated features to
further control shape. Examples of such features include thread,
wires (e.g., metal, including shape-memory alloys), cables,
tethers, rings or a mesh.
[0063] The method for correcting a spinal deformity utilizing an
alternative embodiment of the intercostal spacer device includes,
providing at least one intercostal spacer device 400, the
intercostal device 400 includes a flexible container 402 used to
contain an injectable material, with flexible container 402 being
preferably impermeable to the injectable material, a conduit 406
coupled to flexible container 402 for receiving the injectable
material and a structure 404, that controls at least part of
flexible container 402 after injectable material is injected
through conduit 406 and into flexible container 402. Structure 404
has a shape that is sized and configured for placement between two
adjacent ribs of a patient. The method preferably provides for
intercostal spacer device 400 to be implanted into the intercostal
space between two adjacent ribs. The method would also typically
include injecting the injectable material preferably through
conduit 406 into flexible container 402, the injectable material
being compressible following intercostal spacer device 400
implantation between two adjacent ribs. The compressibility
characteristic ensures that the injectable material exhibits
viscoelastic behavior and that, along with structure 404, the
intercostal spacer device 400 can accept compressive loads and
produce distraction forces for correcting a spinal deformity within
a patient.
[0064] Although the preferred embodiments have been depicted and
described in detail herein, it will be apparent to those skilled in
the relevant art that various modifications, additions and
substitutions can be made without departing from its essence and
therefore these are to be considered to be within the scope of the
following claims.
* * * * *