U.S. patent application number 13/553051 was filed with the patent office on 2013-01-24 for combination photodynamic devices.
This patent application is currently assigned to IlluminOss Medical, Inc.. The applicant listed for this patent is Robert A. Rabiner, Richard Scott Rader. Invention is credited to Robert A. Rabiner, Richard Scott Rader.
Application Number | 20130023876 13/553051 |
Document ID | / |
Family ID | 46881644 |
Filed Date | 2013-01-24 |
United States Patent
Application |
20130023876 |
Kind Code |
A1 |
Rabiner; Robert A. ; et
al. |
January 24, 2013 |
Combination Photodynamic Devices
Abstract
Combination photodynamic devices for repair and stabilization of
a fractured or a weakened bone are disclosed herein. In an
embodiment, a combination photodynamic device includes a load
bearing member and one or more conformable members connected to the
load bearing member, the conformable member expandable from a
deflated state to an inflated state. The load bearing member is
designed to reside inside a cavity of fractured or weakened bone
and act as internal bone fixation and stabilization device. The
conformable member is designed to anchor the load bearing member
inside a bone cavity, transform the load bearing member from a
flexible state to a rigid state, contribute to fixating and
stabilizing a fractured or a weakened bone, and provide
longitudinal and rotational stability to a fractured or a weakened
bone during the healing process or combinations thereof.
Inventors: |
Rabiner; Robert A.;
(Tiverton, RI) ; Rader; Richard Scott; (Wayland,
MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Rabiner; Robert A.
Rader; Richard Scott |
Tiverton
Wayland |
RI
MA |
US
US |
|
|
Assignee: |
IlluminOss Medical, Inc.
|
Family ID: |
46881644 |
Appl. No.: |
13/553051 |
Filed: |
July 19, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61509314 |
Jul 19, 2011 |
|
|
|
61509391 |
Jul 19, 2011 |
|
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|
61509459 |
Jul 19, 2011 |
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Current U.S.
Class: |
606/63 |
Current CPC
Class: |
A61B 17/7097 20130101;
A61N 2005/0612 20130101; A61F 2002/4631 20130101; A61N 5/062
20130101; A61B 17/7258 20130101; A61B 17/7283 20130101; A61B
17/8855 20130101; A61F 2/30749 20130101; A61B 17/74 20130101; A61B
17/8836 20130101; A61B 17/7233 20130101; A61B 17/7275 20130101;
A61F 2002/30934 20130101; A61F 2/3804 20130101; A61B 17/8858
20130101; A61B 17/72 20130101; A61N 5/06 20130101 |
Class at
Publication: |
606/63 |
International
Class: |
A61B 17/72 20060101
A61B017/72 |
Claims
1. A combination photodynamic device comprising: at least one load
bearing member designed to reside in a cavity of a fractured or
weakened bone, the at least one load bearing member acting as an
internal bone fixation and stabilization device; at least one
conformable member connected to the at least one load bearing
member, the at least one conformable member configured to be
expandable from a deflated state to an inflated state to anchor the
at least one load bearing member inside the cavity.
2. The device of claim 1, wherein the at least one conformable
member is expandable from a deflated state to an inflated state
using an expansion fluid.
3. The device of claim 1, wherein the at least one conformable
member is a balloon.
4. The device of claim 1, wherein the at least one conformable
member is designed to transform the at least one load bearing
member from a flexible state for delivery to or removal from the
cavity of the bone to a rigid state for implantation within the
cavity of the bone.
5. The device of claim 1, wherein the at least one conformable
member is detachably or removably attached to the at least one load
bearing member.
6. The device of claim 1, wherein the at least one load bearing
member has a threaded end so that the at least one load bearing
member can be screwed into the bone.
7. The device of claim 1, wherein the at least one load bearing
member is an elongated rod or an intramedullary nail.
8. The device of claim 1, wherein the at least one load bearing
member is made of a flexible material.
9. The device of claim 1, wherein the at least one load bearing
member includes a plurality of nested tubes telescopically slidable
relative to one another.
10. The device of claim 1, wherein the at least one load bearing
member has a compressible body that can be transformed from a
flexible state to a rigid state by a compressive force.
11. The device of claim 1, wherein the at least one load bearing
member is transformable between a flexible state and a rigid state
by radially expanding the at least one load bearing member using
the conformable member placed inside the load bearing member.
12. The device of claim 1, wherein the at least one load bearing
member is as at least partially enclosed by the at least one
conformable member.
13. The device of claim 1, wherein the at least one load bearing
member is adjacent to the at least one conformable member.
14. The device of claim 1, wherein the at least one load bearing
member is a flexible patterned tube or a flexible helical spring,
and the at least one conformable member is configured to be
inserted in the at least one load bearing member and expanded to
transform the at least one load bearing member to a rigid
state.
15. The device of claim 1, further comprising one or more holes in
the at least one load bearing member and/or at least one
conformable member for receiving one or more fasteners to secure
the device to the bone.
16. The device of claim 1, further comprising a cam structure
attached to the at least one load bearing member and configured to
act upon the at least one conformable member to increase pressure
between the at least one load bearing member containing the cam
structure, the at least one conformable member, and/or the weakened
or fractured bone to stabilize the load bearing member in the
cavity of the bone.
17. The device of claim 1, wherein the at least one load bearing
member includes one or more segments.
18. A combination photodynamic device kit comprising: at least one
expansion fluid; a delivery catheter having an elongated shaft with
a proximal end, a distal end, and a longitudinal axis therebetween;
a conformable member releasably engaged to the distal end of the
delivery catheter and wherein the delivery catheter has an inner
void for passing the at least one expansion fluid into the
conformable member; and a load bearing member, wherein the load
bearing member can be engaged with the conformable member.
19. The kit of claim 18, further comprising a plurality of
conformable members of different sizes or shapes.
20. A method for bone repair and stabilization comprising:
inserting a load bearing member into a cavity of a fractured or
weakened bone; inserting one or more conformable members into the
cavity; engaging the one or more conformable members with the load
bearing member; and expanding the conformable member with an
expansion fluid, thereby anchoring the load bearing member inside
the cavity and providing longitudinal and rotational stability to
the load bearing member during the healing process.
21. The method of claim 20, wherein the load bearing member is
flexible when inserted into the cavity, and becomes rigid upon
expanding the conformable member with an expansion fluid.
Description
RELATED APPLICATIONS
[0001] This application claims the benefit of and priority to U.S.
Provisional Patent Application No. 61/509,314, filed on Jul. 19,
2011, U.S. Provisional Patent Application No. 61/509,391, filed on
Jul. 19, 2011, and U.S. Provisional Patent Application No.
61/509,459, filed on Jul. 19, 2011, the entirety of these
applications are hereby incorporated herein by reference.
FIELD
[0002] The embodiments disclosed herein relate to bone implants,
and more particularly to combination photodynamic devices for bone
repair and stabilization.
BACKGROUND
[0003] Bones form the skeleton of the body and allow the body to be
supported against gravity and to move and function in the world.
Bone fractures can occur, for example, from an outside force or
from a controlled surgical cut (an osteotomy). A fracture's
alignment is described as to whether the fracture fragments are
displaced or in their normal anatomic position. In some instances,
surgery may be required to re-align and stabilize the fractured
bone. It is often difficult to properly position and stabilize
fractured or weakened bones. It would be desirable to have an
improved device for repairing and stabilizing a fractured or
weakened bone.
SUMMARY
[0004] Combination photodynamic devices for repair and
stabilization of a fractured or a weakened bone are disclosed
herein. In one aspect, there is a provided a combination
photodynamic device that includes at least one load bearing member
designed to reside in a cavity of a fractured or weakened bone, and
at least one conformable member connected to the at least one load
bearing member. The at least one load bearing member acts as an
internal bone fixation and stabilization device. The at least one
conformable member is configured to be expandable from a deflated
state to an inflated state to anchor the at least one load bearing
member inside the cavity.
[0005] In one embodiment, the at least one conformable member is
expandable from a deflated state to an inflated state using an
expansion fluid. In an embodiment, the at least one conformable
member is a balloon. In an embodiment, the at least one conformable
member is designed to transform the at least one load bearing
member from a flexible state for delivery to or removal from the
cavity of the bone to a rigid state for implantation within the
cavity of the bone. In an embodiment, the at least one conformable
member is detachably or removably attached to the at least one load
bearing member.
[0006] In an embodiment, the at least one load bearing member has a
threaded end so that the at least one load bearing member can be
screwed into the bone. In an embodiment, the at least one load
bearing member is an elongated rod or an intramedullary nail. In an
embodiment, the at least one load bearing member is made of a
flexible material. In an embodiment, the at least one load bearing
member includes a plurality of nested tubes telescopically slidable
relative to one another. In an embodiment, the at least one load
bearing member has a compressible body that can be transformed from
a flexible state to a rigid state by a compressive force. In an
embodiment, the at least one load bearing member is transformable
between a flexible state and a rigid state by radially expanding
the at least one load bearing member using the conformable member
placed inside the load bearing member. In an embodiment, the at
least one load bearing member is as at least partially enclosed by
the at least one conformable member. In an embodiment, the at least
one load bearing member is adjacent to the at least one conformable
member. In an embodiment, the at least one load bearing member is a
flexible patterned tube or a flexible helical spring, and the at
least one conformable member is configured to be inserted in the at
least one load bearing member and expanded to transform the at
least one load bearing member to a rigid state.
[0007] In an embodiment, the device includes one or more holes in
the at least one load bearing member and/or at least one
conformable member for receiving one or more fasteners to secure
the device to the bone. In an embodiment, the device includes a cam
structure attached to the at least one load bearing member and
configured to act upon the at least one conformable member to
increase pressure between the at least one load bearing member
containing the cam structure, the at least one conformable member,
and/or the weakened or fractured bone to stabilize the load bearing
member in the cavity of the bone. In an embodiment, the at least
one load bearing member includes one or more segments.
[0008] In one aspect, a combination photodynamic device kit
includes: at least one expansion fluid; a delivery catheter having
an elongated shaft with a proximal end, a distal end, and a
longitudinal axis therebetween; a conformable member releasably
engaged to the distal end of the delivery catheter and wherein the
delivery catheter has an inner void for passing the at least one
expansion fluid into the conformable member; and a load bearing
member, wherein the load bearing member can be engaged with the
conformable member. In an embodiment, the kit also includes a
plurality of conformable members of different sizes or shapes.
[0009] In one aspect, a method for bone repair and stabilization
includes: inserting a load bearing member into a cavity of a
fractured or weakened bone; inserting one or more conformable
members into the cavity; engaging the one or more conformable
members with the load bearing member; and expanding the conformable
member with an expansion fluid, thereby anchoring the load bearing
member inside the cavity and providing longitudinal and rotational
stability to the load bearing member during the healing process. In
an embodiment, the load bearing member is flexible when inserted
into the cavity, and becomes rigid upon expanding the conformable
member with an expansion fluid.
BRIEF DESCRIPTION OF THE DRAWINGS
[0010] The presently disclosed embodiments will be further
explained with reference to the attached drawings, wherein like
structures are referred to by like numerals throughout the several
views. The drawings shown are not necessarily to scale, with
emphasis instead generally being placed upon illustrating the
principles of the presently disclosed embodiments.
[0011] FIG. 1A shows a schematic illustration of an embodiment of a
combination photodynamic implant including a load bearing member
and a conformable member.
[0012] FIG. 1B shows a schematic illustration of an embodiment of a
combination photodynamic implant including multiple load bearing
members.
[0013] FIG. 1C shows a schematic illustration of an embodiment of a
combination photodynamic implant having a threaded end.
[0014] FIG. 2 shows a schematic illustration of an embodiment of a
bone implant system. The system includes a light source, a light
pipe, an attachment system, a light-conducting fiber, a
light-sensitive liquid, a delivery catheter and a conformable
member.
[0015] FIG. 3A and FIG. 3B show close-up cross-sectional views of
the region circled in FIG. 2. FIG. 3A shows a cross-sectional view
of a distal end of the delivery catheter and the conformable member
prior to the device being infused with light-sensitive liquid. FIG.
3B shows a cross-sectional view of the distal end of the delivery
catheter and the conformable member after the device has been
infused with light-sensitive liquid and light energy from the
light-conducting fiber is introduced into the delivery catheter and
an inner lumen of the conformable member to cure the
light-sensitive liquid.
[0016] FIG. 4A and FIG. 4B illustrate an embodiment of a
combination photodynamic implant having a single-piece load bearing
member.
[0017] FIG. 5A illustrates an embodiment of a combination
photodynamic implant in which a load bearing member is made of a
series of telescoping tubes.
[0018] FIG. 5B illustrates an embodiment of a combination
photodynamic implant in which a load bearing member is a
compressible body.
[0019] FIG. 5C and FIG. 5D illustrate an embodiment of a
combination photodynamic implant in which a conformable member
engages a load bearing member and provides interference in
compression or tension to features of the load bearing member.
[0020] FIGS. 6A-6D illustrate an embodiment of a combination
photodynamic implant in which a load bearing member is
transformable from a flexible state to a rigid state by a
conformable member or a portion thereof.
[0021] FIG. 7A and FIG. 7B illustrate an embodiment of a
combination photodynamic implant in which a load bearing member is
enclosed within a conformable member.
[0022] FIG. 8A and FIG. 8B illustrate an embodiment of a
combination photodynamic implant including one or more conformable
members.
[0023] FIG. 8C-8F illustrate embodiments of a combination
photodynamic implant including an internal cam structure.
[0024] FIG. 8G and FIG. 8H illustrate an embodiment of a
combination photodynamic implant including one or more conformable
members.
[0025] FIG. 9A and FIG. 9B illustrate an embodiment of a
combination photodynamic implant having a modular load bearing
member.
[0026] FIGS. 10A-10F show an embodiment of method steps for using
the systems and device.
[0027] While the above-identified drawings set forth presently
disclosed embodiments, other embodiments are also contemplated, as
noted in the discussion. This disclosure presents illustrative
embodiments by way of representation and not limitation. Numerous
other modifications and embodiments can be devised by those skilled
in the art which fall within the scope and spirit of the principles
of the presently disclosed embodiments.
DETAILED DESCRIPTION
[0028] Medical devices and methods for repairing and stabilizing a
weakened or fractured bone are disclosed herein. As shown in FIG.
1A, a combination photodynamic device 100 of the present disclosure
includes a load bearing member 115 and one or more conformable
members 170 associated with the load bearing member 115. The term
"associated with" as used herein means, either fixedly or
removably, connected to, affixed to, incorporated into, linked
with, attached to, wrapped around, inserted into, mounted over,
received in, or any other physical connection. In an embodiment,
the combination photodynamic device 100 can include multiple load
bearing members 115a, 115b, as shown in FIG. 1B. The load bearing
member 115 is designed to reside inside of a cavity 101 of a bone
105 and act as an internal bone fixation and stabilization device
during the healing of a bone fracture 104. The terms "cavity within
a bone" and "bone cavity" as used herein is intended to include
both natural cavities within a bone, such as the intramedullary
cavity, physician-created cavities, and also cavities created due
to bone diseases. The conformable member 170 is designed to anchor
the load bearing member 115 inside the bone cavity 101 and to
provide longitudinal and rotational stability to the load bearing
member 115 during the healing of the bone fracture 104.
Additionally or alternatively, the conformable member 170 is
designed to transform the load bearing member 115 from a flexible
state for delivery to a bone cavity to a rigid state once inside
the bone cavity inside the bone cavity 101. It should be noted that
in some combination photodynamic implants of the present
disclosure, the conformable member can also function to fixate and
stabilize a fractured or weakened bone or to provide longitudinal
and rotational stability to a fractured or weakened bone, either in
combination with or independently of the load bearing member
115.
[0029] A combination photodynamic device may be used to treat a
fractured or weakened bone. The combination photodynamic devices of
the present disclosure are suitable to treat a fractured or
weakened tibia, fibula, humerus, ulna, femur, radius, metatarsals,
metacarpals, phalanx, phalanges, ribs, spine, vertebrae, clavicle,
pelvis, wrist, mandible, and other bones and still be within the
scope and spirit of the disclosed embodiments. In an embodiment, a
combination photodynamic devices of the present disclosure is used
to stabilize, reinforce or support a weakened bone. In an
embodiment, a combination photodynamic devices of the present
disclosure is used to stabilize a fractured bone in conjunction
with anatomic reduction (i.e., proper reorientation of fractured
elements to their original position, both relative to one another
and relative to other adjacent anatomical features).
[0030] As used herein, the terms "fracture" or "fractured bone"
refer to a partial or complete break in the continuity of a bone.
The fracture can occur, for example, from an outside force or from
a controlled surgical cut (osteotomy). A combination photodynamic
implant can be used to treat any type of bone fracture, including,
but not limited to, a displaced fracture, a non-displaced fracture,
an open fracture, a closed fracture, a hairline fracture, a
compound fracture, a simple fracture, a multi-fragment fracture, a
comminuted fracture, an avulsion fracture, a buckle fracture, a
compacted fracture, a stress fracture, a compression fracture,
multiple fractures in a bone, spiral fracture, butterfly fracture,
other fractures as described by AO Foundation coding, and other
types of fractures.
[0031] As used herein, the term "weakened bone" refers to a bone
with a propensity toward a fracture due to a decreased strength or
stability due to a disease or trauma. Some bone diseases that
weaken the bones include, but are not limited to, osteoporosis,
achondroplasia, bone cancer, fibrodysplasia ossificans progressiva,
fibrous dysplasia, legg calve perthes disease, myeloma,
osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis,
Paget's disease, and scoliosis. Weakened bones are more susceptible
to fracture, and treatment to prevent bone fractures may be
desirable.
[0032] In an embodiment, the combination photodynamic implant may
be used to stabilizing fractured or weakened load bearing bones
including, but not limited to, the femur and tibia bones of the
leg. The use of the combination implant, in an embodiment, allows
for strength of the load bearing member to be imparted through the
use of metal or structural plastics like those listed above and
other suitable materials. In an embodiment, use of the combination
implant allows for minimally invasive placement since the load
bearing member can be a small diameter but filling the internal
cavity can be accomplished with the conformable member(s). In an
embodiment, the combination implant can provide the required
stability with potentially significant load carrying capacity
increase due to the use of particular metal load bearing and
photodynamic conformable members.
[0033] In an embodiment, the load bearing member 115 is
sufficiently designed for implantation into a bone cavity via a
minimally invasive method. The load bearing member 115 may be
flexible or rigid. In an embodiment, the load bearing member 115 is
in a flexible state for delivery to a bone cavity and is
transformed to a rigid state once inside the bone cavity. In an
embodiment, the load bearing member 115 is transformable from a
flexible state to a rigid state by the conformable member 170. The
load bearing member 115 can comprise a single piece or multiple
pieces.
[0034] The load bearing member 115 can be made from a variety of
biocompatible materials including, but not limited to, metal,
composite, plastic or amorphous materials, which include, but are
not limited to, steel, stainless steel, cobalt chromium plated
steel, titanium, nickel titanium alloy (nitinol), superelastic
alloy, and polymethylmethacrylate (PMMA), poly-ether ether ketone
(PEEK), composite materials of polymers and minerals, composite
materials of polymers and glass or polymeric fibers, composite
materials of metal, polymer, and minerals and any other engineering
materials.
[0035] Referring to FIG. 1B, when implanted within a bone cavity,
in addition to being held in place with the one or more conformable
members 170, the photodynamic implant 100 may further be held in
place by any suitable fasteners 102, including, but not limited to,
screws, pins, wires, nails, and bolts. In an embodiment, the load
bearing member 115 may include one or more holes 104 for receiving
fasteners 102 that can be inserted through the bone to secure the
combination photodynamic implant 100 in place. In an embodiment,
the holes 104 are located at the proximal and distal ends of the
load bearing member 115. In an embodiment, the load bearing member
115 are made of a material into which fasteners 102 can be inserted
without providing pre-drilled holes in the load bearing member 115,
such as polyether ether ketone (PEEK). In such an embodiment,
fasteners 102 can be inserted into the load bearing member 115 at a
user selected location anywhere along a length of the load bearing
member 115, at any angle and to any desired depth. A combination
implant of a load bearing member 115 made of a material, such as
PEEK, combined with a conformable member 170, allows user-selected
insertion of fasteners 102 at any location along the implant, at
any angle or desired depth, transiting any combination of bone,
conformable member 170, and/or load bearing member 115 as desired
by the user. Additionally or alternatively, in an embodiment,
fasteners 102 can also be inserted into the conformable member 170
at a user selected location, at any angle and to any desired depth.
Because the fasteners can be inserted at user-selected locations,
the user is able to determine the optimal placement for fasteners
based on each patient's specific situation rather than on the
predrilled holes. In addition, flexible fastener placements
simplifies the procedure by enabling the user to have a
cross-locking screw without targeting to "find" pre-drilled
holes.
[0036] In an embodiment, as shown in FIG. 1C, one end of the load
bearing member 115 is adapted for insertion into a cortical bone.
In an embodiment, the load bearing member includes a threaded end
103 such that the load bearing member 115 can be securely screwed
into cortical bone. In an embodiment, the threaded end 103 of the
load bearing member is tapered to facilitate insertion of the
threaded end 103 into cortical bone.
[0037] In an embodiment, the conformable member 170 is a balloon
expandable from a deflated state to an inflated state by the
addition of at least one expansion fluid. Modification of expansion
fluid infusion allows a user to adjust the size and shape of the
conformable member 170 in its inflated state, as is described
above. Because the shape and size of the conformable members 170
are easily configurable by the user, the conformable member 170 can
be adjusted to achieve a conformal fit with the cavity into which
the combination photodynamic implant 100 is implanted, thereby
ensuring that the implanted combination photodynamic implant 100 is
longitudinally and rotationally secured inside the bone cavity. In
an embodiment, the conformable member 170 can be adjusted to
conform to the internal diameter of the bone cavity into which the
combination photodynamic implant 100 is implanted as well as the
curvature of the bone cavity. In an embodiment, the conformable
member 170 is adjusted to transform the load bearing member 115
from a flexible state to a rigid state. In an embodiment, the
conformable member 170 is adjusted to facilitate fixation,
stabilization, or both of the fractured or weakened bone into which
it is inserted.
[0038] In an embodiment, the expansion fluid is a curable liquid,
that is a liquid that can progress from a flowable form for
delivery to the conformable member 170, such as, for example,
through a catheter, to a non-flowable (e.g., cured) form for final
use in vivo. A cure may refer to any chemical, physical, and/or
mechanical transformation. In an embodiment, the expansion fluid is
a light-sensitive liquid 165, which can be cured inside the
conformable member 170 by exposing it to light energy, as is
described in more detail below. The term "curable" may refer to
uncured liquid, having the potential to be cured in vivo (as by
catalysis or the application of a suitable energy source), as well
as to a liquid in the process of curing (e.g., a composition formed
at the time of delivery by the concurrent mixing of a plurality of
composition components). Curing the curable expansion fluid inside
the conformable member 170 affixes the conformable member 170 in an
expanded shape to form a photodynamic implant. It should be
understood that a photodynamic implant will have the size and shape
substantially similar to a conformable member from which the
photodynamic implant is formed. Although a combination photodynamic
implant with the conformable member 170 containing a cured curable
liquid can be removed from the bone cavity, to simplify the removal
of a combination photodynamic implant, the conformable member 170
can be expanded with a fluid that remains flowable inside the
conformable member 170 so that the conformable member 170 can be
easily deflated and removed, if necessary, thereby facilitating the
removal of the load bearing member. Suitable examples of
non-curable fluids include, but are not limited to, air, water or
buffer solution or any other fluid that is non-curable. It should
be noted that in an embodiment, the conformable member 170 can be
formed by a cured light sensitive liquid, without a balloon.
[0039] In an embodiment, the expansion fluid may be provided as a
unit dose. As used herein, the term "unit dose" is intended to mean
an effective amount of light sensitive liquid adequate for a single
session. By way of a non-limiting example, a unit dose of a light
sensitive liquid of the present disclosure for expanding the
conformable member 170 may be defined as enough expansion fluid to
expand the conformable member 170 to a desired shape and size. The
desired shape and size of the conformable member 170 may vary
somewhat from patient to patient. Thus, a user using a unit dose
may have excess expansion fluid left over. It is desirable to
provide sufficient amount of expansion fluid to accommodate even
the above-average patient. In an embodiment, a unit dose of a
expansion fluid of the present disclosure is contained within a
container. In an embodiment, a unit dose of a expansion fluid of
the present disclosure is contained in an ampoule. In an
embodiment, the conformable member 170 is sufficiently shaped and
sized to fit within a space or a gap in a fractured bone. In an
embodiment, the expansion fluid can be delivered under low pressure
via a standard syringe attached to the port.
[0040] The conformable member 170 may be provided with a shape
demanded by, for example, the anatomy of the implantation site,
characteristics of the load bearing member 115 or both. Suitable
shapes include, but not limited to, round, flat, cylindrical, dog
bone, barbell, tapered, oval, conical, spherical, square,
rectangular, toroidal and combinations thereof. The conformable
member 170 can be manufactured from a non-compliant
(non-stretch/non-expansion) conformable material including, but not
limited to urethane, polyethylene terephthalate (PET), nylon
elastomer and other similar polymers. In an embodiment, the
conformable member 170 is manufactured from a polyethylene
terephthalate (PET). In an embodiment, the conformable member 170
is manufactured from a radiolucent material, which permit x-rays to
pass through the conformable member 170. In an embodiment, the
conformable member 170 is manufactured from a radiolucent
polyethylene terephthalate (PET). In an embodiment, the conformable
member 170 is manufactured from a conformable compliant material
that is limited in dimensional change by embedded fibers. In an
embodiment, at least a portion of the external surface of the
conformable member 170 is substantially even and smooth.
[0041] In an embodiment, at least a portion of the external surface
of the conformable member 170 includes at least one textured
element such as a bump, a ridge, a rib, an indentation or any other
shape. In an embodiment, at least a portion of the external surface
of the conformable member 170 protrudes out to form a textured
element. In an embodiment, at least a portion of the external
surface of the conformable member 170 invaginates to form a
textured element. In an embodiment, the textured element increases
the friction and improves the grip and stability of the conformable
member 170 after the conformable member 170 is inserted into the
fracture location. In an embodiment, the textured element results
in increased interdigitation of bone-device interface as compared
to an conformable member without textured elements. In an
embodiment, the textured element can be convex in shape. In an
embodiment, the textured element can be concave in shape. In an
embodiment, the textured element can be circumferential around the
width of the conformable member 170, either completely or
partially.
[0042] In general, bone graft or bone graft substitute can be used
in conjunction with an conformable member 170 of the present
disclosure. In an embodiment, the bone graft is an allogeneic bone
graft. In an embodiment, the bone graft is an autologous bone
graft. In an embodiment, the bone graft substitute is a
hydroxyapatite bone substitute. In an embodiment, a bone graft or
bone graft substitute is used to fill in any gaps that may exist,
for example, between the external surface of the conformable member
170 and the surfaces of the bone fragments. In an embodiment, a
bone graft or bone graft substitute is used to fill any gaps that
may exist, for example, between the textured element of the
conformable member 170 and the surfaces of the bone fragments.
[0043] In general, the conformable member 170 can include an
external surface that may be coated with materials including, but
not limited to, drugs (for example, antibiotics), proteins (for
example, growth factors) or other natural or synthetic additives
(for example, radiopaque or ultrasonically active materials). For
example, after a minimally invasive surgical procedure an infection
may develop in a patient, requiring the patient to undergo
antibiotic treatment. An antibiotic drug may be added to the
external surface of the conformable member 170 to prevent or combat
a possible infection. Proteins, such as, for example, bone
morphogenic protein or other growth factors have been shown to
induce the formation of cartilage and bone. A growth factor may be
added to the external surface of the conformable member 170 to help
induce the formation of new bone. Due to the lack of thermal egress
of the light-sensitive liquid 165 in the conformable member 170,
the effectiveness and stability of the coating is maintained.
[0044] In general, the conformable member 170 typically does not
have any valves. One benefit of having no valves is that the
conformable member 170 may be expanded or reduced in size as many
times as necessary to assist in the fracture reduction and
placement. Another benefit of the conformable member 170 having no
valves is the efficacy and safety of the system 100. Since there is
no communication passage of light-sensitive liquid 165 to the body
there cannot be any leakage of liquid 165 because all the liquid
165 is contained within the conformable member 170. In an
embodiment, a permanent seal is created between the conformable
member 170 and the delivery catheter 150 that is both hardened and
affixed prior to the delivery catheter 150 being removed.
[0045] In an embodiment, abrasively treating the external surface
of the conformable member 170, for example, by chemical etching or
air propelled abrasive media, improves the connection and adhesion
between the external surface of the conformable member 170 and a
bone surface. The surfacing significantly increases the amount of
surface area that comes in contact with the bone which can result
in a stronger grip.
[0046] FIG. 2 in conjunction with FIG. 3A and FIG. 3B show
schematic illustrations of an embodiment of a system 200 that can
be used to implant the conformable member 170 and infuse the
expansion fluid into the conformable member 170. In the embodiment
where the expansion fluid is a light-sensitive liquid 165, the
system 200 can also be used to cure the light-sensitive liquid 165
inside the conformable member 170. System 200 includes a light
source 110, a light pipe 120, an attachment system 130 and a
light-conducting fiber 140. The attachment system 130 communicates
light energy from the light source 110 to the light-conducting
fiber 140. In an embodiment, the light source 110 emits frequency
that corresponds to a band in the vicinity of 390 nm to 770 nm, the
visible spectrum. In an embodiment, the light source 110 emits
frequency that corresponds to a band in the vicinity of 410 nm to
500 nm. In an embodiment, the light source 110 emits frequency that
corresponds to a band in the vicinity of 430 nm to 450 nm. The
system 200 further includes a flexible delivery catheter 150 having
a proximal end that includes at least two ports and a distal end
terminating in an conformable member 170. In an embodiment, the
conformable member 170 is sufficiently shaped to fit within a space
or a gap in a fractured bone. In an embodiment, the conformable
member 170 is manufactured from a non-compliant
(non-stretch/non-expansion) conformable material. In an embodiment,
the conformable member 170 is manufactured from a conformable
compliant material that is limited in dimensional change by
embedded fibers. One or more radiopaque markers, bands or beads may
be placed at various locations along the conformable member 170
and/or the flexible delivery catheter 150 so that components of the
system 200 may be viewed using fluoroscopy.
[0047] In the embodiment shown in FIG. 2, the proximal end includes
two ports. One of the ports can accept, for example, the
light-conducting fiber 140. The other port can accept, for example,
a syringe 160 housing a light-sensitive liquid 165. In an
embodiment, the syringe 160 maintains a low pressure during the
infusion and aspiration of the light-sensitive liquid 165. In an
embodiment, the syringe 160 maintains a low pressure of about 10
atmospheres or less during the infusion and aspiration of the
light-sensitive liquid 165. In an embodiment, the light-sensitive
liquid 165 is a photodynamic (light-curable) monomer. In an
embodiment, the photodynamic (light-curable) monomer is exposed to
an appropriate frequency of light and intensity to cure the monomer
inside the conformable member 170 and form a rigid structure. In an
embodiment, the photodynamic (light-curable) monomer 165 is exposed
to electromagnetic spectrum that is visible (frequency that
corresponds to a band in the vicinity of 390 nm to 770 nm). In an
embodiment, the photodynamic (light-curable) monomer 165 is
radiolucent, which permit x-rays to pass through the photodynamic
(light-curable) monomer 165.
[0048] As illustrated in FIG. 3A and FIG. 3B, the flexible delivery
catheter 150 includes an inner void 152 for passage of the
light-sensitive liquid 165, and an inner lumen 154 for passage of
the light-conducting fiber 140. In the embodiment illustrated, the
inner lumen 154 and the inner void 152 are concentric to one
another. The light-sensitive liquid 165 has a low viscosity or low
resistance to flow, to facilitate the delivery of the
light-sensitive liquid 165 through the inner void 152. In an
embodiment, the light-sensitive liquid 165 has a viscosity of about
1000 cP or less. In an embodiment, the light-sensitive liquid 165
has a viscosity ranging from about 650 cP to about 450 cP. The
conformable member 170 may be inflated, trial fit and adjusted as
many times as a user wants with the light-sensitive liquid 165, up
until the light source 110 is activated, when the polymerization
process is initiated. Because the light-sensitive liquid 165 has a
liquid consistency and is viscous, the light-sensitive liquid 165
may be delivered using low pressure delivery and high pressure
delivery is not required, but may be used.
[0049] In an embodiment, a contrast material may be added to the
light-sensitive liquid 165 without significantly increasing the
viscosity. Contrast materials include, but are not limited to,
barium sulfate, tantalum, or any other suitable contrast materials.
The light-sensitive liquid 165 can be introduced into the proximal
end of the flexible delivery catheter 150 and passes within the
inner void 152 of the flexible delivery catheter 150 up into an
inner cavity 172 of the conformable member 170 to change a
thickness of the conformable member 170 without changing a width or
depth of the conformable member 170. In an embodiment, the
light-sensitive liquid 165 is delivered under low pressure via the
syringe 160 attached to the port. The light-sensitive liquid 165
can be aspirated and reinfused as necessary, allowing for thickness
adjustments to the conformable member 170 prior to activating the
light source 110 and converting the liquid monomer 165 into a hard
polymer.
[0050] As illustrated in FIG. 2 in conjunction with FIG. 3B, the
light-conducting fiber 140 can be introduced into the proximal end
of the flexible delivery catheter 150 and passes within the inner
lumen 154 of the flexible delivery catheter 150 up into the
conformable member 170. The light-conducting fiber 140 is used in
accordance to communicate energy in the form of light from the
light source to the remote location. The light-sensitive liquid 165
remains a liquid monomer until activated by the light-conducting
fiber 140 (cures on demand). Radiant energy from the light source
110 is absorbed and converted to chemical energy to polymerize the
monomer. The light-sensitive liquid 165, once exposed to the
correct frequency light and intensity, is converted into a hard
polymer, resulting in a rigid structure or photodynamic implant. In
an embodiment, the monomer 165 cures in about five seconds to about
five minutes. This cure affixes the conformable member 170 in an
expanded shape to form a photodynamic implant.
[0051] Light-conducting fibers use a construction of concentric
layers for optical and mechanical advantages. The light-conducting
fiber can be made from any material including, but not limited to,
glass, silicon, silica glass, quartz, sapphire, plastic,
combinations of materials, or any other material, and may have any
diameter. In an embodiment, the light-conducting fiber is made from
a polymethyl methacrylate core with a transparent polymer cladding.
The light-conducting fiber can have a diameter between
approximately 0.75 mm and approximately 2.0 mm. In some
embodiments, the light-conducting fiber can have a diameter of
about 0.75 mm, about 1 mm, about 1.5 mm, about 2 mm, less than
about 0.75 mm or greater than about 2 mm. In an embodiment, the
light-conducting fiber may be made from a polymethyl methacrylate
core with a transparent polymer cladding. It should be appreciated
that the above-described characteristics and properties of the
light-conducting fibers are exemplary and not all embodiments of
the present disclosure are intended to be limited in these
respects. Light energy from a visible emitting light source can be
transmitted by the light-conducting fiber. In an embodiment,
visible light having a wavelength spectrum of between about 380 nm
to about 780 nm, between about 400 nm to about 600 nm, between
about 420 nm to about 500 nm, between about 430 nm to about 440 nm,
is used to cure the light-sensitive liquid.
[0052] The most basic function of a fiber is to guide light, i.e.,
to keep light concentrated over longer propagation
distances--despite the natural tendency of light beams to diverge,
and possibly even under conditions of strong bending. In the simple
case of a step-index fiber, this guidance is achieved by creating a
region with increased refractive index around the fiber axis,
called the fiber core, which is surrounded by the cladding. The
cladding may be protected with a polymer coating. Light is kept in
the "core" of the light-conducting fiber by total internal
reflection. Cladding keeps light traveling down the length of the
fiber to a destination. In some instances, it is desirable to
conduct electromagnetic waves along a single guide and extract
light along a given length of the guide's distal end rather than
only at the guide's terminating face.
[0053] In some embodiments of the present disclosure, at least a
portion of a length of an light-conducting fiber is modified, e.g.,
by removing the cladding, in order to alter the profile of light
exuded from the light-conducting fiber. The term "profile of light"
refers to, without limitation, direction, propagation, amount,
intensity, angle of incidence, uniformity, distribution of light
and combinations thereof. In an embodiment, the light-conducting
fiber emits light radially in a uniform manner, such as, for
example, with uniform intensity, along a length of the
light-conducting fiber in addition to or instead of emitting light
from its terminal end/tip. To that end, all or part of the cladding
along the length of the light-conducting fiber may be removed. It
should be noted that the term "removing cladding" includes taking
away the cladding entirely to expose the light-conducting fiber as
well as reducing the thickness of the cladding. In addition, the
term "removing cladding" includes forming an opening, such as a
cut, a notch, or a hole, through the cladding. In an embodiment,
removing all or part of the cladding may alter the propagation of
light along the light-conducting fiber. In another embodiment,
removing all or part of the cladding may alter the direction and
angle of incidence of light exuded from the light-conducting
fiber.
[0054] In an embodiment, the cladding is removed by making a
plurality of cuts in the cladding to expose the core of the
light-conducting fiber. In an embodiment, the cladding is removed
in a spiral fashion. In an embodiment, the cladding is removed in
such a way that a similar amount of light is exuded along the
length of the modified section of the light-conducting fiber. In
another embodiment, the cladding is removed in such a way that the
amount of light exuded along the length of the modified section of
the light-conducting fiber changes from the distal end to the
proximal end of the modified section. In another embodiment, the
cladding is removed in such a way that the amount of light exuded
along the modified section of the light-conducting fiber decreases
from the distal end of the modified section of the light-conducting
fiber toward the proximal end thereof. In an embodiment, to alter
the profile of the light exuded from the modified section, the cuts
in the cladding are located along the length of the fiber in a
spiral. In an embodiment, the pitch or spacing between the cuts is
varied along the length of the modified section of the
light-conducting fiber. In an embodiment, the spacing between the
cuts increases from the proximal end of the modified section of the
light-conducting fiber 165 to the distal end thereof such that the
amount of light exuded from the modified section of the
light-conducting fiber progressively increases toward the distal
end of the modified section of the light-conducting fiber.
[0055] Once the light-sensitive liquid 165 is cured within the
conformable member 170 to form a photodynamic implant, the light
conducting fiber 165 is withdrawn from the system 200 and the
conformable member 170 is separated from the delivery catheter 150.
In an embodiment, a separation area is located at the junction
between the distal end of the conformable member 170 and the
delivery catheter 150 to facilitate the release of the photodynamic
implant 510 from the delivery catheter 150. The separation area
ensures that there are no leaks of reinforcing material from the
elongated shaft of the delivery catheter and/or the conformable
member 170. The separation area seals the photodynamic implant and
removes the elongated shaft of the delivery catheter by making a
break at a known or predetermined site (e.g., a separation area).
The separation area may be various lengths and up to about an inch
long. The separation area may also a stress concentrator, such as a
notch, groove, channel or similar structure that concentrates
stress in the separation area. The stress concentrator is designed
to ensure that the conformable member 170 is separated from the
delivery catheter 150 at the separation area. When torque
(twisting) is applied to the delivery catheter 150, the conformable
member 170 separates from the shaft of the delivery catheter 150.
The twisting creates a sufficient shear to break the residual
reinforcing material and create a clean separation of the
conformable member 170/shaft interface. It should of course be
understood that the conformable member 170 may be separated from
the delivery catheter 150 by any other means known and used in the
art.
[0056] FIGS. 4-9 show various non-limiting embodiments of
combination photodynamic implants of the present disclosure. It
should be noted that the load bearing member and the conformable
member in each embodiment described below are not limited to
features specifically described in connection with the particular
embodiment, but may also can include features of the load bearing
members and conformable members described above and features of the
load bearing members and conformable members described in
connection with other embodiments.
[0057] Referring to FIG. 4A and FIG. 4B, in an embodiment, a
combination photodynamic implant 400 includes a load bearing member
115 and one or more conformable members 170 associated with the
bearing member 115. In an embodiment, the load bearing member 115
is a rigid elongated rod designed for implantation into a bone
cavity. In an embodiment, the load bearing member 115 is a rigid
intramedullary nail, made of a metallic material such as stainless
steel or titanium. In an embodiment, the load bearing member 115 is
made of a flexible or semi-rigid material, such as PEEK, fiber
reinforced composite polymers, or another engineering
thermoplastic. The one or more conformable members 170 may be
disposed at the ends of the load bearing member 115, as shown in
FIG. 4A, or a distance away from the ends of the load bearing
member 115, as shown in FIG. 4B. Although the combination
photodynamic implant 400 in FIG. 4A and FIG. 4B is illustrated as
having two conformable members 170, the combination photodynamic
implant 400 can include any number of conformable members 170. The
conformable member 170 can be positioned and engage the load
bearing member 115 to provide longitudinal placement stability of
the load bearing member 115, rotational placement stability of the
load bearing member 115, or both. In an embodiment, these
stabilizing actions impart both positional stability of the
combination photodynamic implant 400, as well as provide stability
to the intended use of the bone and implant combination.
[0058] FIG. 5A and FIG. 5B illustrate embodiments of a combination
photodynamic implant 500 in which a load bearing member 115 may be
transformable between a flexible state and a rigid state. The load
bearing member 115 can be transformed between a flexible state for
delivery to or removal from a bone cavity to a rigid state for
implantation within the bone cavity. In an embodiment, the load
bearing member 115 comprises a plurality of nested tubes 502, 504,
506 telescopically slidable one within another, as shown in FIG.
5A. In an embodiment, the telescopic tubes 502, 504, 506 may
include a locking mechanism (not shown) such that the telescopic
tubes 502, 504, 506 are slidable relative to one another when
unlocked and fixed in position relative to one another when locked.
In an embodiment, locking the telescopic tubes 502, 504, 506
relative to one another also transforms the load bearing member 115
from a flexible state to a rigid state. The locking mechanism can
be any mechanism suitable for locking telescopic tubes.
[0059] In an embodiment, as shown in FIG. 5B, the load bearing
member 115 has a compressible body 515 that can be transformed from
a flexible state to a rigid state by a compressive force. In an
embodiment, the conformable member 170 is passed through the
compressible body 515 and, when expanded, compresses the
compressible body 515 to transform the compressible body 515 from a
flexible state to a rigid state. In an embodiment, the compressible
body 515 may include an actuator to apply and remove a compressive
force on the compressible body 515, thereby transforming the
compressible body between a flexible state and a rigid state.
Examples of suitable compressive bodies include, but are not
limited to, a tubular spring or coil, a segmented or patterned
tube, a chain of ball bearings, a chain of cylinders, a bellow-like
structure, and similar. Such compressible bodies are known and are
disclosed, for example, in U.S. Pat. No. 7,909,825.
[0060] In reference to FIG. 5C and FIG. 5D, in an embodiment, the
load bearing member 520 has a transformable body that can be
transitioned from a flexible to a rigid state when the conformable
member 170 engages the load bearing member 520 and provides
interference in compression or tension to features of the load
bearing member 520. FIG. 5C illustrates the conformable member 170
in a deflated state positioned inside the load bearing member 520.
When the conformable member 170 is moved from the deflated state to
an inflated state, as shown in FIG. 5D, the conformable member 170
can extend radially out of the openings 540 between struts 542 of
the transformable load bearing member 520 to transform the load
bearing member 520 from a flexible state to a rigid state. In an
embodiment, because the conformable member 170 fills in the
openings 540, the conformable member 170 prevents the translation
or compression of the load bearing member 520 back to a flexible
state.
[0061] In some embodiments of a combination photodynamic implant,
the load bearing member is transformable between a flexible state
and a rigid state by radially expanding the load bearing member 115
by the conformable member 170 placed inside the load bearing member
115. Various suitable designs for the load bearing member 115 of
the combination photodynamic implant 600 are disclosed, for
example, in U.S. Pat. No. 7,909,825. In an embodiment, the
conformable member 170 is inserted inside the load bearing member
and is expanded to transform the load bearing member 115 from a
flexible state to a rigid state. In an embodiment, the design of
the load bearing member 115 is such that a light-sensitive liquid
can be contained inside the load bearing member 115 without a
conformable member 170, such that the light-sensitive liquid can be
infused directly into the load bearing member 115 to expand the
load bearing member 115.
[0062] FIG. 6A and FIG. 6B illustrate embodiments of a combination
photodynamic implant in which the load bearing member is
transformable between a flexible state and a rigid state by
radially expanding the load bearing member by the conformable
member 170 placed inside the load bearing member.
[0063] As shown in FIG. 6A, in an embodiment, the load bearing
member may be a patterned tube 620. The patterned tube 620 may be
flexible during the delivery of the patterned tube 620 to a bone
cavity. Once the patterned tube 620 is inside the bone cavity, the
conformable member 170 can be inserted into the patterned tube 620
and expanded to transform the patterned tube 620 to a rigid
state.
[0064] As shown in FIG. 6B, in an embodiment, the load bearing
member is a helical spring 630. The helical spring 630 is flexible
during the delivery of the helical spring 630 to a bone cavity.
Once the helical spring 630 is inside the bone cavity, the
conformable member 170 can be inserted into the helical spring 630
and expanded to transform the patterned tube 620 to a rigid
state.
[0065] In an embodiment, as shown in FIG. 6A, in addition to the
conformable member 170 inside the load bearing member, one or more
distinct conformable members 170 can be placed over the load
bearing member or patterned tube 620 placed inside the load bearing
member 620 to stiffen the load bearing member 620.
[0066] In an embodiment, as shown in FIG. 6B, the conformable
member 170 is longer than the load bearing member 640 such that the
conformable member 170 extends outside the load bearing member 640
and achieves a conformal fit with the bone cavity into which the
photodynamic implant 600 is implanted to lock the load bearing
member 640 in place inside the bone cavity. In embodiment, as shown
in FIG. 6B, the conformable member 170 can also be configured to
extend radially out of the openings 640 in the body of the load
bearing member 640 to contact the wall of the bone cavity in which
the implant 600 is implanted. In an embodiment, the load bearing
member can also be made of a tubular spring or coil, a chain of
ball bearings, a chain of cylinders, a bellow-like structure, and
similar.
[0067] In an embodiment, the load bearing member of the combination
photodynamic implant 600 can have a diameter similar to the inner
diameter of the bone cavity into which the implant 600 is implanted
such that the load bearing member undergoes no, or only a minimal
amount of, radial expansion by the conformable member.
[0068] In reference to FIG. 6C and FIG. 6D, in an embodiment, to
facilitate less invasive delivery of the combination photodynamic
implant 600 to a bone cavity, the load bearing member 620 can be
provided with a diameter smaller than the inner diameter of the
bone cavity. In an embodiment, when the conformable member 170
expands inside the load bearing member 115, the load bearing member
115 is also expanded radially to approximate the inner diameter of
the bone cavity. In an embodiment, as shown in FIG. 6C and FIG. 6D,
expanding the load bearing member 115 can cause the load bearing
member to contract in the longitudinal direction, thereby
stiffening the load bearing member 115 and locking the load bearing
115 in place within the cavity. In an embodiment, the load bearing
member 115 has a design such that there is no foreshortening in the
longitudinal direction when the load bearing member 115 is
expanded.
[0069] FIG. 7A illustrates an embodiment of a combination
photodynamic implant 700 in which a load bearing member 620 is at
least partially enclosed by a conformable member 170. FIG. 7B is a
cross-sectional side view of the combination photodynamic implant
700 of FIG. 7A.
[0070] In an embodiment, the load bearing member is transformable
between a flexible state and a rigid state. The load bearing member
may have any design as described in regard to combination
photodynamic implants 500 and 600. Upon delivering the combination
photodynamic implant 700 to a bone cavity, the conformable member
170 can be expanded, thereby expanding and stiffening the load
bearing member 620 and, at the same time, locking the load bearing
member 620 in place within the bone cavity. In an embodiment, the
load bearing member may be rigid, such as described above in
reference to combination photodynamic implant 400. Curing a
light-sensitive liquid inside the conformable member can further
stiffen the load bearing member and assist the load bearing member
in stabilizing the bone.
[0071] FIG. 8A and FIG. 8B illustrate an embodiment of a
combination photodynamic implant 800 in which one or more
conformable members 170 may act as cams to stabilize the load
bearing member 115 in a bone cavity 802 of a bone 804 into which
the load bearing member 115 is implanted. FIG. 8A shows a
combination photodynamic implant 800 having one or more conformable
members 170 acting as cams to stabilize the load bearing member
115. FIG. 8B shows such combination photodynamic implant 800 in a
bone cavity 802 of a bone 804. In an embodiment, the one or more
conformable members are placed about a load bearing member 115
between the load bearing member 115 and the walls of the bone
cavity 802. In an embodiment, the one or more conformable members
170 can be permanently attached to the load bearing member 115. In
an embodiment, the one or more conformable members 170 are
detachably attached to the load bearing member 115.
[0072] In an embodiment, use of multiple conformable members 170
facilitates both tightening to slightly increase radial tension of
conformable member 170 structures on cortical wall, as well as
reversibility to decrease tension to simplify the removal of the
combination photodynamic implant 800. In an embodiment, the one or
more conformable members 170 may be filled with a non-curable
fluid, that is a fluid that will remain flowable (i.e. non-cured)
inside the one or more conformable members 170, such as air or
water or buffer solution, to ensure the ease of removal of the one
or more conformable members 170.
[0073] In an embodiment, the conformable members 170 that at least
partially enclose or encircle the load bearing member, as shown in
FIG. 8B, stabilize the load bearing member, and through contact
with the cancellous or cortical wall of the bone, fixate and
stabilize the fractured bone. In an embodiment, this method of
stabilization may not require the use of cross-locking screws used
in load bearing intramedullary rods to facilitate longitudinal and
rotational stability to allow the bone to heal. The placement of
cross-locking screws into intramedullary rods is often time
consuming, require the use of targeting jigs and/or fluoroscopy to
ensure that the cross-locking screw enters into pre-defined holes
in metallic implants in particular. In an embodiment, by not
requiring the use of cross-locking screws, the combination implant
illustrated in FIG. 8B can securely stabilize a fractured or
weakened bone, while simultaneously eliminating or limiting the
time and tissue dissection necessary to place cross-locking screws
at exact locations in particular in metallic intramedullary
nails.
[0074] Referring to FIG. 8C, FIG. 8D, and FIG. 8E, in an
embodiment, the combination photodynamic implant 800 includes an
internal cam structure 810. The one or more conformable members 170
are acted upon by the cam structure 810 to enable user-adjustable
tension or compression to increase pressure between the load
bearing member 115 containing the cam structure 810, the one or
more conformable members 170 and/or the cortical bone to stabilize
the load bearing member 115 in the bone cavity 802 of the bone 804.
In an embodiment, use of multiple conformable members 170
facilitates both tightening via the action of the cam structure 810
contained in or a part of the load bearing member 115 to slightly
increase radial tension of the multiple conformable members 170 on
cortical wall, as well as reversibility to decrease tension to
simplify the removal of the combination photodynamic implant 800.
Once the conformable members 170 are expanded with the expansion
fluid, and, in the instance when the expansion fluid comprises the
curable liquid, the curable liquid is hardened, rotating the
internal cam structure 810 into a locking position, as shown in
FIG. 8C, pushes the conformable members into the wall of the bone
cavity 802, thereby increasing radial pressure on the cortical
wall, securely locking the combination photodynamic implant 800
inside the bone cavity 802. Rotating the internal cam structure 810
into a release position, as shown in FIG. 8D, releases the pressure
on the conformable member 170, thereby enabling the repositioning
or removal of the conformable members 170 and, consequently, the
repositioning or removal of the load bearing member 115, as shown
in FIG. 8E.
[0075] FIG. 8F shows another embodiment of the cam structure shown
in FIG. 8C, FIG. 8D, and FIG. 8E where the conformable members 170
are moved in and away from the bone 804. In an embodiment, a
process known as dynamization is used to spur healing of bones,
including, but not limited to, the femur and tibia. With
traditional intramedullary nails that are locked to the bone via
cross-locking screws, if the bone does not begin healing quickly,
the surgeon may remove one to many screws, thereby loosening the
implant. Fully rigid fixation almost eliminates micro-motion at the
fracture, and when this is not present the normal stress on the
bone is gone which can slow or interrupt the healing process which
responds positively to small motions and stress. In an embodiment,
the process of dynamization can be used to loosen an implant so
that the two ends of the bone move towards each other, creating
compression across the fracture line, which also can help stimulate
the healing response particularly in the femur and tibia. In an
embodiment, the cam structure shown in FIG. 8F could also be used
as a dynamization step where the implant is slightly loosened
within the bone, allowing either the force of standing (or just
putting pressure on the leg without full standing weight) to
provide compression across the fracture line, or enough loosening
such that low stress and micromotion is imparted to stimulate the
bone healing response.
[0076] In another embodiment, as shown in FIG. 8G, at least one or
more bone fixation devices 820 including, but not limited to, cross
locking screws, can be placed across the cortical bone 804 anywhere
into the cured conformable member 170 to provide addition
longitudinal or rotational stability. Simple targeting may
represent a significant time and fluoroscopy dose savings as exact
match to pre-existing holes will not be required. In an embodiment,
the surgeon can place the bone fixation device 820 such as a cross
locking screw anywhere along the length of the conformable
member(s) 170, thereby securing the whole combination implant 800
and bone construct to facilitate healing or reinforcement of
weakened bone.
[0077] FIG. 8H shows an embodiment of a bone implant 800 where the
load bearing member 115 is adjacent to at least one conformable
member 170. In an embodiment, a load bearing member 114 is
entrained by the conformable member(s) 170 that are adjacent to the
load bearing member 115 longitudinally. In addition to having the
conformable member 170 positioned radially outward from the load
bearing member 115, as shown in FIG. 8C, for example, and partially
enclosing the load bearing member 115 rotationally, in an
embodiment, a conformable member 170 is placed at each end of the
load bearing member 115 along the longitudinal axis of the load
bearing member 115 holding the load bearing member 115 in place and
thereby limiting the axial movement of the load bearing member
115.
[0078] FIG. 9A and FIG. 9B illustrate an embodiment of a
combination photodynamic implant 900 of the present disclosure in
which the load bearing member 115 is modular. In an embodiment, the
load bearing member can be made up of multiple segments 902, 904
attachable to one another in an end to end fashion. Each segment
has a first end 902a, 904a and a second end 902b, 904b, wherein the
second end 902b of a first segment 902 can be attached to the first
end 904a of a second segment 904 adjacent to the first segment 902.
In an embodiment, the second end 902b of the first segment 902 can
be in the form of a male fitting and the first end 904a of the
second segment 904 can be in the form of a female coupling such
that the first segment 902 and the second segment 904 can be joined
together, as shown in FIG. 9B. Any other suitable means for
connection of the first and second segments 902, 904 can also be
employed. In operation, the first segment 902 and the second
segment 904 can be delivered to a bone cavity separately and
assembled inside the bone cavity. In an embodiment, to help ensure
that the first segment 902 and the second segment 904 are aligned,
the load bearing member can be assembled over an obturator. Once
the modular load bearing member 115 is assembled inside the bone
cavity, the conformable member 170 can be inserted into the
assembled load bearing member 115 and expanded to increase the
strength and rigidity of the load bearing member 115. In an
embodiment, the conformable member 170 can expand outside of the
load bearing member 115, as shown in FIG. 9B. In this manner, the
conformable member 170 can bias the segments of the load bearing
member 115 toward one another, thereby ensuring that the load
bearing member 115 does not come apart. Moreover, in this manner,
the conformable member may be used to add rotational and
longitudinal stability to the load bearing member 115. In an
embodiment, the inner void of the modular load bearing member may
sealed so that a light-sensitive liquid can be infused into the
inner void of the modular load bearing member 115 without a
balloon.
[0079] FIGS. 10A-10F illustrate an embodiment of method steps for
implanting an expandable portion of an intramedullary implant of
the present disclosure within the intramedullary space of a
weakened or fractured bone. A minimally invasive incision (not
shown) is made through the skin of the patient's body to expose a
fractured bone 1002. The incision may be made at the proximal end
or the distal end of the fractured bone 1002 to expose the bone
surface. Once the bone 1002 is exposed, it may be necessary to
retract some muscles and tissues that may be in view of the bone
1002. As shown in FIG. 10A, an access hole 1010 is formed in the
bone by drilling or any other suitable methods. The access hole
1010 may have any suitable diameter. In an embodiment, the access
hole 1010 has a diameter of about 3 mm to about 10 mm. In an
embodiment, the access hole 1010 has a diameter of about 3 mm.
[0080] The access hole 1010 extends through a hard compact outer
layer 1020 of the bone into the relatively porous inner or
cancellous tissue 1025. For bones with marrow, the medullary
material should be cleared from the medullary cavity prior to
insertion of the inventive device. Marrow is found mainly in the
flat bones such as hip bone, breast bone, skull, ribs, vertebrae
and shoulder blades, and in the cancellous material at the proximal
ends of the long bones like the femur and humerus. Once the
medullary cavity is reached, the medullary material including air,
blood, fluids, fat, marrow, tissue and bone debris should be
removed to form a void. The void is defined as a hollowed out
space, wherein a first position defines the most distal edge of the
void with relation to the penetration point on the bone, and a
second position defines the most proximal edge of the void with
relation to the penetration site on the bone. The bone may be
hollowed out sufficiently to have the medullary material of the
medullary cavity up to the cortical bone removed. Any suitable
method for removing the medullary material may be used. Suitable
methods include, but are not limited to, those described in U.S.
Pat. No. 4,294,251 entitled "Method of Suction Lavage," U.S. Pat.
No. 5,554,111 entitled "Bone Cleaning and Drying system," U.S. Pat.
No. 5,707,374 entitled "Apparatus for Preparing the Medullary
Cavity," U.S. Pat. No. 6,478,751 entitled "Bone Marrow Aspiration
Needle," and U.S. Pat. No. 6,358,252 entitled "Apparatus for
Extracting Bone Marrow."
[0081] As shown in FIG. 10B, a guidewire 1028 may be introduced
into a bone cavity 1003 the bone 1002 via the access hole 1010 and
placed between bone fragments 1004 and 1006 of the bone 1002 to
cross the location of a fracture 1005. The guidewire 1028 may be
delivered into the bone cavity 1003 and positioned across the
location of the break 1005 so that the guidewire 1028 spans
multiple sections of bone fragments.
[0082] Next, as shown in FIG. 10B and FIG. 10C, a combination
photodynamic implant of the present disclosure can be delivered
over the guidewire 1028 into the bone cavity 1003. The combination
photodynamic implant is placed to cross the fracture 1005 and spans
the bone fragments 1004 and 1006 of the bone 1002. In an
embodiment, the load bearing member 115 is delivered to the bone
cavity 1003 first and then the conformable member 170 is delivered
to the bone cavity and is associated with the load bearing member
115. It should be noted that although as illustrated the delivery
of the load bearing member 115 precedes the delivery of the
conformable member 170, the sequence of delivery will depend on the
design of the combination photodynamic implant utilized in the
procedure, design of the combination photodynamic implant, user's
preference or combination thereof.
[0083] Once the conformable member 170 and the load bearing member
115 are in the desired position, the guidewire 1028 may be removed.
The location of the conformable member 170 and the load bearing
member 115 is determined using at least one radiopaque marker 1030
which may be detectable from the outside or the inside of the bone
1002. Next, the conformable member 170 is expanded by adding the
expansion fluid to the conformable member 170 through the inner
void of the delivery catheter 150, as shown in FIG. 10D. As the
conformable member 170 expands, the conformable member 170 stiffens
the load bearing member 115, lock the load bearing member 115 in
place, or both, depending on the design of the combination
photodynamic implant utilized in the procedure.
[0084] In the embodiment where a light-sensitive liquid is used to
expand the conformable member 170, a delivery system which contains
a light-sensitive liquid is attached to the port of the delivery
catheter 150 in communication with the inner void of the delivery
catheter 150. The light-sensitive liquid is then infused through
the inner void in the delivery catheter 150 into the conformable
member 170. This addition of the light-sensitive liquid within the
conformable member 170 causes the conformable member 170 to expand,
as shown in FIG. 10D. FIG. 2, FIG. 3A and FIG. 3B also show an
example of a system for expanding the conformable member 170 with a
light-sensitive liquid 165. Once orientation of the bone fragments
1004 and 1006 as well as the position of the load bearing member
115 and conformable member 170 are confirmed to be in a desired
position, the light-sensitive liquid may be hardened within the
conformable member 170, as shown in FIG. 10E, such as by
illumination with a visible emitting light source. In an
embodiment, during the curing step, a syringe housing a cooling
media may be attached to the proximal end of the insertion catheter
and continuously delivered to the conformable member 170. The
cooling media can be collected by connecting tubing to the distal
end of the inner lumen and collecting the cooling media via the
second distal access hole. After the light-sensitive liquid has
been hardened, the light source may be removed from the device.
Alternatively, the light source may remain in the conformable
member 170 to provide increased rigidity.
[0085] Referring to FIG. 10F, the expanded conformable member 170
may be released from the delivery catheter 150 by any suitable
method, thereby forming a combination photodynamic implant 1030. In
an embodiment, the expanded conformable member 170 achieves a
conformal fit with the bone cavity 1025 to provide longitudinal and
rotational stability to the combination photodynamic implant 1030.
Additionally or alternatively, one or more fasteners 102 may be
inserted through the bone into the photodynamic implant 1030 to
further stabilize the photodynamic implant within the bone cavity
1025 of the fractured bone 1002. In an embodiment, an external bone
plate 1130 may be attached to the combination photodynamic implant
1030, as shown in FIG. 10F.
[0086] In one aspect, a combination photodynamic device includes at
least one load bearing member designed to reside in a cavity of a
fractured or weakened bone, and at least one conformable member
connected to the at least one load bearing member. The at least one
load bearing member acts as an internal bone fixation and
stabilization device. The at least one conformable member is
configured to be expandable from a deflated state to an inflated
state to anchor the at least one load bearing member inside the
cavity.
[0087] In an embodiment, a combination photodynamic device of the
present disclosure includes a load bearing member and one or more
conformable members associated with the load bearing member, the
conformable member expandable from a deflated state to an inflated
state with an expansion fluid. The load bearing member is designed
to reside inside of a cavity within a bone and act as internal bone
fixation and stabilization device, while the conformable member is
designed to anchor the load bearing member inside the
intramedullary cavity to provide longitudinal and rotational
stability to the load bearing member. In an embodiment, expanding
the conformable member from a deflated state to an expanded state
locks the load bearing member in place within a bone cavity into
which its implanted as well as transforms the load bearing member
from a flexible state to a rigid state.
[0088] In one aspect, a method for bone repair and stabilization
includes: inserting a load bearing member into a cavity of a
fractured or weakened bone; inserting one or more conformable
members into the cavity; engaging the one or more conformable
members with the load bearing member; and expanding the conformable
member with an expansion fluid, thereby anchoring the load bearing
member inside the cavity and providing longitudinal and rotational
stability to the load bearing member during the healing
process.
[0089] In an embodiment, a method for bone repair and stabilization
that includes inserting a load bearing member into a cavity of a
fractured or weakened bone, inserting one or more conformable
members into the cavity, associating the one or more conformable
members with the load bearing member, and expanding the conformable
member with an expansion fluid, thereby anchoring the load bearing
member inside the intramedullary cavity, providing longitudinal and
rotational stability to the load bearing member during the healing
process, transforming the load bearing member from a flexible state
to a rigid state, contributing to fixating and stabilizing a
fractured or a weakened bone, providing longitudinal and rotational
stability to a fractured or a weakened bone during the healing
process or combinations thereof.
[0090] In one aspect, a combination photodynamic device kit
includes: at least one expansion fluid; a delivery catheter having
an elongated shaft with a proximal end, a distal end, and a
longitudinal axis therebetween; a conformable member releasably
engaged to the distal end of the delivery catheter and wherein the
delivery catheter has an inner void for passing the at least one
expansion fluid into the conformable member; and a load bearing
member, wherein the load bearing member can be engaged with the
conformable member.
[0091] In an embodiment, there is provided a combination
photodynamic device kit that includes a unit dose of at least one
expansion fluid, a delivery catheter having an elongated shaft with
a proximal end, a distal end, and a longitudinal axis therebetween,
wherein a conformable member is releasably engaged to the distal
end of the delivery catheter and wherein the delivery catheter has
an inner void for passing the at least one expansion fluid into the
conformable member, and a load bearing member, wherein the load
bearing member can be associated with the conformable member. In an
embodiment, the kit includes a plurality of conformable members of
different sizes or shapes. In an embodiment, the kit includes a
light source.
[0092] All patents, patent applications, and published references
cited herein are hereby incorporated by reference in their
entirety. It will be appreciated that several of the
above-disclosed and other features and functions, or alternatives
thereof, may be desirably combined into many other different
systems or application. Various presently unforeseen or
unanticipated alternatives, modifications, variations, or
improvements therein may be subsequently made by those skilled in
the art.
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