U.S. patent application number 13/005654 was filed with the patent office on 2011-07-21 for rotary-rigid orthopaedic rod.
Invention is credited to Michael P. Brenzel, Paul Hindrichs, Kyle Taylor.
Application Number | 20110178520 13/005654 |
Document ID | / |
Family ID | 44278087 |
Filed Date | 2011-07-21 |
United States Patent
Application |
20110178520 |
Kind Code |
A1 |
Taylor; Kyle ; et
al. |
July 21, 2011 |
ROTARY-RIGID ORTHOPAEDIC ROD
Abstract
Apparatus and method for repairing a fractured bone. The
apparatus and methods may involve an intramedullary rod. The rod
may include a first elongated member and a second elongated member.
Each of the first and second elongated members may be configured to
bend in a first direction and to resist bending in a second
direction. The first and second elongated members may be arranged
such that: (1) the rod is bendable when the first direction of the
first elongated member is aligned with the first direction of the
second elongated member; and (2) the rod is rigid when the first
direction of the first elongated member is aligned with the second
direction of the second elongated member. Some embodiments may
include rods that have sections that may be configured to be curved
and rigid.
Inventors: |
Taylor; Kyle; (Brooklyn
Park, MN) ; Hindrichs; Paul; (Plymouth, MN) ;
Brenzel; Michael P.; (St. Paul, MN) |
Family ID: |
44278087 |
Appl. No.: |
13/005654 |
Filed: |
January 13, 2011 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61295244 |
Jan 15, 2010 |
|
|
|
Current U.S.
Class: |
606/62 |
Current CPC
Class: |
A61B 2017/00964
20130101; A61B 17/7208 20130101; A61B 17/7258 20130101; A61B
2017/00862 20130101; A61B 17/7225 20130101; A61B 17/7283 20130101;
A61B 17/7266 20130101 |
Class at
Publication: |
606/62 |
International
Class: |
A61B 17/58 20060101
A61B017/58 |
Claims
1. An intramedullary rod comprising: a first elongated member and a
second elongated member, each of the first and second elongated
members having a first direction and a second direction and being
configured to bend in the first direction and to resist bending in
the second direction; wherein the elongated members are arranged
such that: the rod is bendable when the first direction of the
first elongated member is aligned with the first direction of the
second elongated member; and the rod is rigid when the first
direction of the first elongated member is aligned with the second
direction of the second elongated member.
2. The intramedullary rod of claim 1 wherein the first elongated
member is disposed coaxially within the second elongated
member.
3. The intramedullary rod of claim 1 wherein each of the first
directions corresponds to an arrangement of slots that are
longitudinally spaced from each other.
4. The intramedullary rod of claim 3 wherein the slots are
configured to provide tension relief.
5. The intramedullary rod of claim 3 wherein the slots are
configured to provide compression relief.
6. The intramedullary rod of claim 2 wherein: the first directions
correspond to: a first arrangement of slots that are longitudinally
spaced from each other for tension relief; and a second arrangement
of slots that are longitudinally spaced from each other to provide
compression relief; and the first and second arrangements of slots
are spaced circumferentially apart from each other on one of the
elongated members.
7. The intramedullary rod of claim 1 wherein the first and second
elongated members include, respectively, a first and second anchor
receiving feature.
8. The intramedullary rod of claim 7 wherein the first and second
elongated members are configured to be positioned relative to each
other such that the first and second anchor receiving features are
positioned to receive the same anchor.
9. The intramedullary rod of claim 8 wherein the first and second
anchor receiving features are distal a first and a second
arrangement of slots.
10. The intramedullary rod of claim 9 wherein the first and second
elongated members include, respectively, a third and fourth anchor
receiving feature.
11. The intramedullary rod of claim 10 wherein the third and fourth
anchor receiving features are proximal the first and second
arrangements of slots.
12. The intramedullary rod of claim 1 further comprising, when the
rod includes a longitudinal axis, a locking mechanism that
includes: a first attachment to the first elongated member; a
second attachment to the second elongated member; and a bridging
member that is configured to prevent relative rotation about the
longitudinal axis of the first elongated member with respect to the
second elongated member.
13. The intramedullary rod of claim 12 wherein one of the first and
second attachments is threaded.
14. The intramedullary rod of claim 1 wherein the first elongated
member comprises a fixed-curve portion that includes a fixed curve,
the fixed curve defining a fixed-curve plane, the fixed-curve plane
including the second direction of the first elongated member.
15. The intramedullary rod of claim 14 wherein, when the
fixed-curve portion is a first fixed-curve portion, the second
elongated member comprises a second fixed-curve portion that
includes a second fixed curve, the second fixed curve defining a
second fixed-curve plane, the second fixed curve plane including
the second direction of the second elongated member.
16. The intramedullary rod of claim 14 wherein: the fixed-curve
portion includes a first segment and a second segment, the second
segment being attached to the first segment; the first segment
includes a first rigid bend; the second segment includes a second
rigid bend; and, when the first and second bends lie in the
fixed-curve plane, the fixed-curve portion is resistant to bending
in the fixed-curve plane and the fixed curve portion is not
resistant to bending in a plane that is different from the
fixed-curve plane.
17. The intramedullary rod of claim 14 wherein the first segment is
linked to the second segment by an articulating linkage.
18. The intramedullary rod of claim 14 wherein the first and second
segments are formed from a unitary body.
19. The intramedullary rod of claim 18 wherein the unitary body is
a tube.
20. The intramedullary rod of claim 1 wherein the first elongated
member comprises a segment that includes: a first end that includes
a first linkage that has a first pivot axis, the first linkage
providing a connection to a first neighboring segment; and a second
end that is spaced a distance apart from the first end and includes
a second linkage that has a second pivot axis, the second linkage
providing a connection to a second neighboring segment; wherein:
the distance defines a longitudinal axis; and the second pivot axis
is angularly offset, about the longitudinal axis, from the first
pivot axis.
21. The intramedullary rod of claim 20 wherein the second pivot
axis defines the second direction of the first elongated
member.
22. The intramedullary rod of claim 20 wherein the first pivot axis
defines the first direction of the first elongated member.
23. The intramedullary rod of claim 1 wherein the first elongated
member comprises a segment that includes: a first end that includes
a first linkage that has a first pivot axis, the first linkage
providing a connection to a first neighboring segment; and a second
end that is spaced a distance apart from the first end and includes
a second linkage that has a second pivot axis, the second linkage
providing a connection to a second neighboring segment; wherein:
the distance defines a longitudinal axis; and the first and second
pivot axes define intersecting lines when the segment is viewed
along a direction that is substantially normal to the longitudinal
axis.
24. The intramedullary rod of claim 23 wherein the second pivot
axis defines the second direction of the first elongated
member.
25. The intramedullary rod of claim 23 wherein the first pivot axis
defines the first direction of the first elongated member.
26. The intramedullary rod of claim 23 wherein the second pivot
axis is angularly offset, about the longitudinal axis, from the
first pivot axis.
27. The intramedullary rod of claim 26 wherein the first and second
elongated members include, respectively, a first and second anchor
receiving feature.
28. The intramedullary rod of claim 27 wherein the first and second
elongated members are configured to be positioned relative to each
other such that the first and second anchor receiving features are
positioned to receive the same anchor.
29. The intramedullary rod of claim 1 further comprising a bone
support extending from an end of one of the first and second
elongated members.
30. The intramedullary rod of claim 29 further comprising, when the
bone support is a first bone support and the end is a first end, a
second bone support extending from a second end of one of the first
and second elongated members.
31. An intramedullary rod comprising: an outer tubular member that
is configured to bend about a first axis; and an inner member
disposed inside the outer tubular member, the inner member
including a segment that is configured to move: relative to a first
attached neighboring segment, about a second axis; and relative to
a second attached neighboring segment opposite the first attached
neighboring segment, about a third axis; wherein: the second axis
is substantially parallel to the first axis; and the third axis is
substantially perpendicular to the first axis.
32. The intramedullary rod of claim 31 wherein the inner member is
configured to rotate, relative to the outer tubular member, from a
first position in which the second axis is parallel to the first
axis, and the rod is bendable, to a second position in which the
third axis is substantially perpendicular to the first axis, and
the rod is resistant to bending.
33. The intramedullary rod of claim 31 wherein the segment is
configured to move relative to the first and second neighboring
segments by respective operation of first and second articulating
linkages.
34. The intramedullary rod of claim 33 wherein the segment, the
first neighboring segment and the second neighboring segment are
formed from a unitary body.
35. The intramedullary rod of claim 34 wherein the unitary body is
a tube.
36. A method for delivering an intramedullary rod to a bone, the
method comprising: inserting a flexible intramedullary rod through
an angled access hole into an intramedullary channel; and
configuring the intramedullary rod in a rigid configuration by
aligning a bending feature of a first sleeve with a non-bending
feature of a second sleeve.
37. The method of claim 36 further comprising, when the bone has a
longitudinal axis, drilling the angled access hole at angle to the
bone axis.
38. The method of claim 36 further comprising, when the bone
includes an intramedullary space, preparing the intramedullary
space to receive the rod.
39. The method of claim 36 further comprising aligning the first
and second sleeves.
40. The method of claim 36 further comprising inserting the rod
into the intramedullary space.
41. The method of claim 36 further comprising rotating the first
sleeve relative to the second sleeve.
42. The method of claim 36 further comprising fixing a rotational
offset between the first sleeve and the second sleeve.
43. The method of claim 36 further comprising anchoring a distal
end of the rod to the bone.
44. The method of claim 36 further comprising applying a tension to
the rod.
45. The method of claim 36 further comprising anchoring a proximal
end of the rod to the bone.
46. The method of claim 36 further comprising expanding a bone
support at one end of the rod.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a nonprovisional of U.S. Provisional
Applications No. 61/295,244, filed on Jan. 15, 2010, which is
hereby incorporated by reference in its entirety.
FIELD OF TECHNOLOGY
[0002] Aspects of the disclosure relate to providing apparatus and
methods for repairing bone fractures. In particular, the disclosure
relates to apparatus and methods for repairing and/or stabilizing
bone fractures utilizing a device that is inserted into a bone.
BACKGROUND OF THE INVENTION
[0003] Currently, there are many known ways to treat long bone
fractures. Common fracture treatments include: (1) nonsurgical
immobilization; (2) osteosuture and tension band technologies; (3)
percutaneous fixation (e.g., using pins, wires, screws etc.); (4)
rigid intramedullary nailing (e.g., using a large rod and external
screws); (5) flexible plate osteosynthesis (e.g., a "load sharing"
suture); (6) arthroplasty (e.g., using a prosthesis); (7) plating
and other indication specific techniques. Severe fractures that
meet certain clinical criteria may require surgical repair rather
than non-surgical immobilization.
[0004] The midshaft of an elongated or long bone is typically
classified as the diaphysis.
[0005] In general, fracture fixation may provide longitudinal
(along the long axis of the bone), transverse (across the long axis
of the bone), and rotational (about the long axis of the bone)
stability. Fracture fixation may also preserve normal biologic and
healing function.
[0006] There are two primary categories for surgical fixation: a
device that is within the skin (internal fixation); and a device
that extends out of the skin (external fixation). There are two
common types of internal fixation approaches for long bone surgery
(a) a plate that is screwed to the outside of the bone; or (b) a
rod that goes down the center of the bone.
[0007] Plates are characterized by relatively invasive surgery,
support of fractured bone segments from one side outside of bone,
and screws that anchor into the plate and through the entire bone.
Successful repair is dependent on fracture pattern, bone quality,
and patient tolerance of a foreign body, among other factors.
Plates may not properly address the alignment and stability
requirements for periarticular and intrarticular fractures.
[0008] Intramedullary rods or nails, such as those used in mid
shaft treatments, are often used instead of plates and screws to
reduce soft-tissue trauma and complications. Typically, an
intramedullary rod or nail is fixed in diameter and is introduced
into the medullary canal through an incision in the articular
surface.
[0009] Flexible intramedullary rod-like solutions utilize
structures that can be flexed for insertion into the medullary
cavity through a diaphyseal or metaphyseal access site. The
structures may then be made rigid inside the intramedullary cavity.
The structures are often reinforced with polymers or cements.
Making the structures rigid is important for surgical fixation.
[0010] It would be desirable, therefore, to provide apparatus and
methods for bone fracture alignment and stabilization.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The objects and advantages of the invention will be apparent
upon consideration of the following detailed description, taken in
conjunction with the accompanying drawings, in which like reference
characters refer to like parts throughout, and in which:
[0012] FIG. 1 shows illustrative apparatus in accordance with
principles of the invention;
[0013] FIG. 2 shows a partial cross-section taken along lines 2-2
(shown in FIG. 1)
[0014] FIG. 3 shows a perspective view, taken approximately along
lines 3-3, of a portion of the apparatus shown in FIG. 1, when the
apparatus is in a first configuration;
[0015] FIG. 4 shows a partial cross-section taken along the lines
4-4 (shown in FIG. 3).
[0016] FIG. 5 shows a partial cross-section taken along the lines
5-5 (shown in FIG. 3).
[0017] FIG. 6 shows the view of FIG. 3 when the apparatus is in a
second configuration.
[0018] FIG. 7 shows a perspective view of a portion of the
apparatus shown in FIG. 1.
[0019] FIG. 8 shows the apparatus of FIG. 1, along with other
apparatus and a bone;
[0020] FIG. 9 shows a partial cross-sectional view of a portion of
the apparatus shown in FIG. 1 taken along lines 9-9 (shown in FIG.
1).
[0021] FIG. 10 shows a partial cross-sectional view of a portion of
the apparatus shown in FIG. 1 taken along lines 10-10 (shown in
FIG. 1).
[0022] FIG. 11 shows a partial cross-sectional view taken along
lines 11-11 (shown in FIG. 1) when the apparatus is in a
configuration that is different from that shown in FIG. 1.
[0023] FIG. 12 shows the apparatus of FIG. 1, along with other
apparatus and a different bone.
[0024] FIG. 13 shows a flat model representation of features of
apparatus such as that shown in FIG. 1.
[0025] FIG. 14 shows schematic apparatus in accordance with the
principles of the invention.
[0026] FIG. 15 shows other schematic apparatus in accordance with
the principles of the invention.
[0027] FIG. 16 shows other apparatus in accordance with the
principles of the invention.
[0028] FIG. 17 shows yet other apparatus in accordance with the
principles of the invention.
[0029] FIG. 18 shows still other apparatus in accordance with the
principles of the invention.
[0030] FIG. 19 shows a portion of the apparatus shown in FIG.
18.
[0031] FIG. 20 shows a partial cross-sectional view, taken along
lines 20-20 (shown in FIG. 19), of the apparatus shown in FIG.
19.
[0032] FIG. 21 shows a pattern that may be used to manufacture
apparatus in accordance with the principles of the invention.
[0033] FIG. 22 shows illustrative steps of a process in accordance
with the principles of the invention.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0034] Apparatus and method for repairing a fractured bone are
provided. The apparatus and methods may involve an intramedullary
rod. The rod may include a first elongated member and a second
elongated member. An elongated member may be referred to herein as
a sleeve. Each of the first and second elongated members may be
configured to bend in a first direction and to resist bending in a
second direction. The first and second elongated members may be
arranged such that: (1) the rod is bendable when the first
direction of the first elongated member is aligned with the first
direction of the second elongated member; and (2) the rod is rigid
when the first direction of the first elongated member is aligned
with the second direction of the second elongated member.
[0035] An elongated member may be an elongated tubular member. The
first elongated member may be disposed coaxially within the second
elongated member. The inner member may have a length that is
longer, shorter or substantially the same as the length of outer
member. The inner elongated member may include a central
longitudinal void or may be solid, essentially solid or porous. The
inner elongated member may rotate freely within an outer elongated
member.
[0036] The elongated member may include implantable materials such
as metals, polymers, composites and any other suitable
materials.
[0037] The first direction may correspond to an arrangement of
stress-relief features. The stress-relief features may include
slots that are longitudinally spaced from each other. The slots may
be stress-relief slots. The slots may be configured to provide
tension relief. The slots may be configured to provide compression
relief. Slots may be longitudinally separated by ribs. The ribs
and/or slots may be circumferentially separated by one or more
longitudinal members.
[0038] Slots may be formed by different cut patterns/arrangements
in an elongated member. The different patterns/arrangements may
provide different bending properties. Slots, holes or other void
features may be provided by laser cutting or any other suitable
method.
[0039] Different materials may be used to construct an elongated
member, and different materials may provide different bending
properties. Properties of features of an elongated member such as
angular separation, thickness, height, separation, ratio of height
to separation, composition or material, structure or microstructure
or other suitable properties may provide different bending
properties. The properties of an elongated member may vary along
the longitudinal axis of the elongated member.
[0040] The stress-relief features may include any suitable
microstructure, such as one or more of the following: sinters,
kerfs, cuts, cells, perforations, holes, patterns, helical paths,
cells, slots, tapers, angled cuts and any other suitable structure
or microstructure.
[0041] The first direction of an elongated member may correspond
to: (a) a first arrangement of slots that are longitudinally spaced
from each other for tension relief; and (b) a second arrangement of
slots that are longitudinally spaced from each other to provide
compression relief. The first and second arrangements of slots may
be spaced circumferentially apart from each other on one of the
elongated members.
[0042] The apparatus may include a delivery cannula. The delivery
cannula may provide a curved entry path into an intramedullary
channel through an access hole in a bone.
[0043] The apparatus may include a control shaft. The control shaft
may extend through the delivery cannula. The control shaft may
manipulate one or more elongated members. The control shaft may be
removed after elongated members are rotationally locked or rod is
locked to bone. Anchors may lock an elongated member and attach rod
to bone.
[0044] The intramedullary rod may include adjustment flanges. The
adjustments flanges may be used to adjust the first and second
elongated members relative to each other in a circumferential
direction.
[0045] An elongated member may include an anchor-receiving feature.
The anchor-receiving feature may include holes or voids in the
elongated member. The anchor-receiving feature may be tapered, may
include mesh-like cells that are configured to engage an anchoring
device or may have different sizes, parameters or features. The
spacing between the anchor-receiving features and the size and
shape of the anchor-receiving features may be configured to
cooperate with one or more types of different anchors. The
anchor-receiving features may be may be sized as to
interact/cooperate with each other. The anchor-receiving features
may be sized or shaped differently to reduce or relieve angular
stress between an inner and outer elongated member.
[0046] The first and second elongated members may include,
respectively, a first anchor-receiving feature and a second
anchor-receiving feature. The first and second elongated members
may be configured to be positioned relative to each other such that
the first anchor-receiving feature and the second anchor-receiving
feature are positioned to receive the same anchor. The first and
second anchor-receiving features may be distal the first and second
arrangements of slots.
[0047] The first and second elongated members may include,
respectively, a third anchor-receiving feature and a fourth
anchor-receiving feature. The first and second elongated members
may be configured to be positioned relative to each other such that
the third anchor-receiving feature and the fourth anchor-receiving
feature are positioned to receive the same anchor. The third and
fourth anchor receiving features may be proximal the first and
second arrangements of slots.
[0048] Anchors may penetrate one or more of the anchor-receiving
features and secure one elongated member relative to another
elongated member. Anchors may prevent the elongated members from
rotating out of alignment. Anchors may penetrate bone and may used
to apply tension across a bone fracture.
[0049] An elongated member may include one or more elastic
sections. An elastic section may apply a compressive or a tensile
force between proximal and distal anchors of the elongated member.
The tensile force may be applied across the bone fracture by
anchoring the elongated member such that the elastic section is in
compression. The compressive force may be applied across the bone
fracture by anchoring the elongated member such that the elastic
section in tension.
[0050] The rod may include a locking mechanism. The locking
mechanism may include: (a) a first attachment to the first
elongated member; (b) a second attachment to the second elongated
member; and (c) a bridging member that is configured to prevent
relative rotation about the longitudinal axis of the first
elongated member with respect to the second elongated member. One
or both of the first and second attachments may be threaded.
[0051] The locking mechanism may include one or more of a threaded
nut, a sect screw, a cotter pin, a crimp, a swage, a morse taper
and any other suitable mechanical interface or mechanism.
[0052] In some embodiments, the first elongated member may include
a fixed-curve portion. The fixed-curve portion may have a fixed
curve. The fixed curve may define a fixed-curve plane. The fixed
curve plane may include the second direction of the first elongated
member.
[0053] In some embodiments, the first elongated member may include
a first fixed-curve portion and the second elongated member may
include a second fixed-curve portion. The second fixed-curve
portion may have a second fixed curve. The second fixed curve may
define a second fixed-curve plane. The second fixed curve plane may
include the second direction of the second elongated member.
[0054] In some embodiments, the intermedullary rod may be fixed in
a rigid state that includes one or more straight sections and one
or more curved sections. In some embodiments, rotation of a first
elongated member relative to a second elongated member may cause
rod to become rigid in a curved or bent configuration to provide
mechanical support to different portions of a bone.
[0055] A fixed-curve portion may include a first segment and a
second segment. A segment may be a compound segment. The second
segment may be directly attached to the first segment. The first
segment may include a first rigid bend. The second segment may
include a second rigid bend. When the first and second bends lie in
the fixed-curve plane: (a) the fixed-curve portion may be resistant
to bending in the fixed-curve plane; and (b) the fixed curve
portion may be non-resistant to bending in a plane that is
different from the fixed-curve plane.
[0056] The first segment may be linked to the second segment by an
articulating linkage. The articulating linkage may include a female
linkage member and/or a male linkage member. The first and second
segments may be formed from a unitary body. The unitary body may be
a tube.
[0057] The first elongated member may include a segment that has a
first end that includes a first linkage that has a first pivot
axis. The first linkage may provide a connection to a first
neighboring segment. The segment may have a second end that is
spaced a distance apart from the first end. The second end may
include a second linkage. The second linkage may include a second
pivot axis. The second linkage may provide a connection to a second
neighboring segment. The distance may define a longitudinal axis.
The distance may define a direction that may be referred to as a
longitudinal axis. The second pivot axis may be angularly offset,
about the longitudinal axis, from the first pivot axis.
[0058] The first pivot axis may define the first direction of the
first elongated member.
[0059] The second pivot axis may define the second direction of the
first elongated member.
[0060] The segment may include a first end that includes a first
linkage. The first linkage may have a first pivot axis. The first
linkage may provide a connection to a first neighboring segment.
The segment may include a second end. The second end may be spaced
a distance apart from the first end. The second end may include a
second linkage. The second linkage may have a second pivot axis.
The second pivot axis may provide a connection to a second
neighboring segment.
[0061] The distance may define a longitudinal axis. The distance
may define a direction that may be referred to a longitudinal axis.
The first and second pivot axes may define intersecting lines when
the segment is viewed along a direction that is substantially
normal to the longitudinal axis.
[0062] The first pivot axis may define the first direction of the
first elongated member.
[0063] The second pivot axis may define the second direction of the
first elongated member.
[0064] The second pivot axis may be angularly offset, about the
longitudinal axis, from the first pivot axis.
[0065] A segment may include a segment body. The segment body may
include one or more implantable material such as metal, polymer,
composite and any other suitable material. The segment body may
include one or more forms such as a cylinder, a prism, a curve and
any other suitable shape.
[0066] The segment may be one of a chain of segments. The chain of
segments may form all or a portion of the elongated member of the
intermedullary rod. The segment chain may be placed inside an outer
elongated member. The outer member may be provided with stress
relief features that are distributed along the length and
circumference of the member. A relative orientation of the chain
and the outer elongated member may allow the rod to be oriented in
a bendable or rigid orientation.
[0067] The rod may include a bone support extending from an end of
the first and/or second elongated members. The end may be a
proximal or a distal end. The rod may include two bone supports.
One of the bone supports may extend from the first elongated
member. The other may extend from the second elongated member.
[0068] The bone support may be fixed to one or more bone fragments.
Fixation to bone may include using any suitable anchoring
device.
[0069] In some embodiments, the rod may include an outer tubular
member that is configured to bend about a first axis and an inner
member disposed inside the outer tubular member. The inner member
may include a segment that is configured to move: (a) relative to a
first attached neighboring segment, about a second axis; and (b)
relative to a second attached neighboring segment opposite the
first attached neighboring segment, about a third axis.
[0070] The second axis may be substantially parallel to the first
axis. The third axis may be substantially perpendicular to the
first axis.
[0071] The inner member may be configured to rotate, relative to
the outer tubular member, from a first position in which the second
axis is parallel to the first axis, and the rod is bendable, to a
second position in which the third axis is substantially
perpendicular to the first axis, and the rod is resistant to
bending.
[0072] The segment may be configured to move relative to the first
and second neighboring segments by respective operation of first
and second articulating linkages.
[0073] The segment, the first neighboring segment and the second
neighboring segment may be formed from a unitary body. The unitary
body may be a tube.
[0074] The methods may include a method for delivering an
intramedullary rod to a bone. The method may include inserting a
flexible intramedullary rod through an angled access hole into an
intramedullary channel; and configuring the intramedullary rod in a
rigid configuration by aligning a bending feature of a first sleeve
with a non-bending feature of a second sleeve.
[0075] The method may include drilling the angled access hole at an
angle to a longitudinal axis of the bone. The method may include
preparing an intramedullary space to receive the rod. The method
may include aligning the first and second sleeves to make the rod
flexible. The method may include inserting the rod into the
intramedullary space. The method may include rotating the first
sleeve relative to the second sleeve to make the rod inflexible.
The method may include fixing a rotational offset between the first
sleeve and the second sleeve.
[0076] The method may include anchoring a distal end of the rod to
the bone. The method may include applying a tension to the rod. The
method may include anchoring a proximal end of the rod to the
bone.
[0077] The method may include expanding a bone support at one end
of the rod.
[0078] The apparatus and methods of the invention will be described
in connection with embodiments and features of an illustrative bone
repair device and associated hardware and instrumentation. The
device and associated hardware and instruments will be described
now with reference to the FIGS. It is to be understood that other
embodiments may be utilized and structural, functional and
procedural modifications may be made without departing from the
scope and spirit of the present invention. It will be understood
that features shown in connection with one or more of the
embodiments may be practiced in accordance with the principles of
the invention along with features shown in connection with other
embodiments.
[0079] FIG. 1 shows illustrative rotary-rigid rod 100. Rod 100 may
include outer sleeve 140 and inner sleeve 150. Inner sleeve 150 may
have a length that is longer, shorter or substantially the same as
the length of outer sleeve 140. The sleeves may be constructed of
metal, polymer, composite or other suitable material. In some
embodiments, the sleeves may be constructed from Nitinol tube. Void
features, such as holes and slots, some of which are shown and
described herein, may be provided by laser cutting or any other
suitable method.
[0080] Outer sleeve 140 may include proximal end 142 and distal end
144. Inner sleeve 150 may include proximal end 152 and distal end
154. Outer sleeve 140 may include center section 146. Inner sleeve
150 may have corresponding center section 156 (shown in FIG. 2).
Rotary-rigid rod 100, in the configuration shown in FIG. 1, may
have longitudinal axis L.sub.1. In some embodiments, rotary-rigid
rod 100 may have an essentially annular cross section that is
substantially perpendicular to axis L.sub.1. Proximal end 142 and
proximal end 152 may include, respectively, adjustment flanges 160
and 170. Adjustment flanges 160 and 170 may be used to adjust
sleeves 140 and 150 relative to each other in circumferential
direction C or -C about axis L.sub.1.
[0081] FIG. 2 shows a proximal portion of rotary-rigid rod 100.
Inner sleeve 150 is shown substantially flush and coaxially aligned
with outer sleeve 140. Inner sleeve 150 may include a central
longitudinal void or may be solid, essentially solid or porous.
Inner sleeve 150 may rotate freely within outer sleeve 140.
[0082] Outer sleeve 140 may include outer holes 241a, 241b and
241c, collectively referred to henceforth as outer holes 241. Inner
sleeve 150 may include inner holes 251a, 251b and 251c,
collectively referred to henceforth as inner holes 251. Outer holes
240 and inner holes 250 may be aligned or partially aligned when
inner sleeve 150 is in one or more rotational positions with
respect to outer sleeve 140.
[0083] While only a few of holes shown in FIG. 2 are labeled, it
should be apparent that numerous holes of this type may be a part
of rod 100. The holes may include mesh-like cells that are
configured to engage an anchoring device.
[0084] In some embodiments, rod 100 may include corresponding holes
in distal ends of sleeves 140 and 150.
[0085] Outer sleeve center section 146 may include outer ribs 242a,
242b and 242c, collectively referred to henceforth as outer ribs
242. Inner sleeve center section 156 may include inner ribs 252a,
252b and 252c, collectively referred to henceforth as inner ribs
252.
[0086] FIG. 3 shows outer sleeve 140 and inner sleeve 150 in an
aligned configuration. In the aligned configuration, outer ribs 242
are aligned in circumferential direction C with inner ribs 252.
Inner ribs 254, opposite inner ribs 252, are aligned with outer
ribs 244, opposite outer ribs 242. Outer ribs 242 and 244 may be
circumferentially separated from each other by longitudinal members
246 and 248. Inner ribs 252 and 254 may be circumferentially
separated from each other by longitudinal members 256 and 258.
[0087] Angle .alpha. defines the circumferential extent of member
256. Angle .alpha. may have any suitable magnitude. For example,
angle .alpha. may range from a fraction of a degree to almost 180
degrees. In some embodiments, angle .alpha. may be about 90
degrees. Corresponding angles define the circumferential extent of
members 246, 248 and 258. In some embodiments, one or more of the
angles corresponding to angle .alpha. may have a magnitude that is
different from that of angle .alpha..
[0088] Angle .beta. defines the circumferential separation between
members 256 and 258. Angle .beta. may have any suitable magnitude.
For example, angle .beta. may range from a fraction of a degree to
almost 180 degrees. In some embodiments, angle .beta. may be about
90 degrees. A corresponding angle defines the circumferential
separation between members 246 and 248. In some embodiments, one or
more of the angles corresponding to angle .beta. may have a
magnitude that is different from that of angle .beta..
[0089] Different magnitudes of angles .alpha. and .beta., and the
corresponding angles, may produce in each of sleeves 140 and 150
different bending properties along axis L.sub.1. When the sleeves
are rotated about axis L.sub.1 relative to each other, rod 100 may
exhibit different bending properties based on the different angular
magnitudes.
[0090] For example, outer ribs 242 and 244 permit outer sleeve 140
to bend along axis L.sub.1 (about axis L.sub.2) in the direction of
either outer rib portion. Inner ribs 252 and 254 permit inner
sleeve 150 to bend along axis L.sub.1 (about axis L.sub.2) in the
direction of either inner rib portion.
[0091] To the extent that inner ribs and outer ribs are non-aligned
with each other, rod 100 may exhibit resistance to bending along
axis L.sub.1.
[0092] Increased thickness t.sub.0 of longitudinal members 246 and
248 may increase the bending resistance of outer member 140 along
axis L.sub.1 about axis L.sub.2. Increased thickness t.sub.i of
longitudinal members 256 and 258 may increase the bending
resistance of inner member 150 along axis L.sub.1 about axis
L.sub.2.
[0093] FIGS. 4 and 5 show heights h.sub.0 and h.sub.i of ribs 242
and 252, respectively. Ribs 242 and 252 may be spaced apart by
spacings s.sub.o and s.sub.i, respectively. Relatively greater or
lesser ratios h.sub.o:S.sub.o and h.sub.i:s.sub.i may decrease or
increase, respectively, the bending resistances of sleeves 140 and
150.
[0094] One or more of longitudinal members 246, 248, 256 and 258
may include a composition or material that provides a relatively
greater or lesser degree of bending resistance along axis L.sub.1
about axis L.sub.2. Suitable compositions or materials may include
implantable materials such as metals, polymers, composites and any
other suitable materials.
[0095] One or more of longitudinal members 246, 248, 256 and 258
may include a structure or microstructure that provides a
relatively greater or lesser degree of bending resistance along
axis L.sub.1 about axis L.sub.2. Suitable structure or
microstructure may include: sinter, kerfs, cuts, cells,
perforations, holes, patterns, helical paths, cells, slots, tapers,
angled cuts and any other suitable structure or microstructure.
[0096] Properties such as angle .alpha., angle .beta., thickness
t.sub.o, thickness t.sub.i, height h.sub.o, height h.sub.i,
separation s.sub.o, separation s.sub.i, ratio h.sub.o:s.sub.o,
ratio h.sub.i:s.sub.i, composition or material, structure or
microstructure and other suitable properties may vary along axis
L.sub.1.
[0097] FIG. 6 shows inner sleeve 150 rotated by angle .gamma.
relative to outer sleeve 140. Inner ribs 252 are now aligned with
longitudinal member 246. Outer member 246 may thus provide
resistance to a bending moment about axis L.sub.3. Longitudinal
member 248 may provide corresponding resistance on the opposite
side of rod 100. Longitudinal members 256 and 258 may similarly
provide resistance to bending about axis L.sub.2. When .gamma. is
at or near 0.degree., bending resistance of rod 100 along L.sub.1
about L.sub.2 will be relatively greater. When .gamma. is at or
near 90.degree., bending resistance of rod 100 will be relatively
lesser.
[0098] FIG. 7 shows portions of outer sleeve 140 and inner sleeve
150 in perspective view when .gamma. is slightly greater than
0.degree..
[0099] FIG. 8 shows rod 100 when .gamma. is at or near 0.degree.,
bending upon delivery to intramedullary space IS in bone B. Bone B
includes mid-shaft fracture F. Angled delivery tube 800 is present
in angled access hole H in bone B. Outer sleeve 150 and inner
sleeve 140 are aligned so that rod 100 can bend about axis L.sub.2.
(It will be appreciated that axes L.sub.2 and L.sub.3 are not fixed
longitudinally along axis L.sub.1.)
[0100] After placement in intramedullary space IS, outer sleeve 140
and inner sleeve 150 may be rotated such that .gamma. is at or near
90.degree. to provide rod 100 with bending resistance. In some
embodiments, the rotation may provide rod 100 with rigidity.
[0101] In some embodiments, rod 100 may be anchored after setting
.gamma. at a desired value. Rod 100 may anchor distal fracture F by
fastening anchors in holes 802 at distal ends 144 and 154 of rods
140 and 150, respectively. Rod 100 may anchor proximal fracture F
by fastening anchors in holes such as 240 and 250 (shown in FIG. 2)
in proximal ends 142 and 152 of outer and inner sleeves 140 and
150, respectively.
[0102] Anchors such as screws that penetrate an outer and an inner
hole secure outer sleeve 140 relative to inner sleeve 150 and
prevent the sleeves from rotating out of alignment. Any suitable
type of anchor may be used.
[0103] Compression or tension may be applied across fracture F
between the distal and proximal fastenings. The tension may be
applied by a practitioner after the distal anchors are placed. Rod
100 may include one or more elastic sections. An elastic section
may apply a compressive or a tensile force between proximal and
distal anchors of rod 100. The tensile force may be applied across
fracture F by anchoring rod 100 such that the elastic section is in
compression. The compressive force may be applied across fracture F
by anchoring rod 100 such that the elastic section in tension.
[0104] In some embodiments, adjustment flanges 160 and 170 may be
set relative to each other to prevent sleeves 140 and 150 from
rotating out of alignment. The setting may be based on
inter-threading, cooperating keyed members, a keyed or mating outer
sleeve, a pin or any other suitable mechanism.
[0105] Setting elements may be integrated into rod 100 at proximal
or distal ends of rod 100 or anywhere along the length of rod 100.
The setting elements may be separate from rod 100. The setting
elements may include one or more of a threaded nut, a sect screw, a
cotter pin, a crimp, a swage, a morse taper and any other suitable
mechanical interface or mechanism.
[0106] FIG. 8 shows holes 802 in distal end 144 of outer sleeve
140.
[0107] FIG. 9 shows that holes 802 may pass through wall thickness
w.sub.o of distal end 144. One or more of holes 802 may be tapered
at angle .delta..sub.o relative to normal direction N.sub.o. One or
more of holes 802 may have a radius r.sub.o. Two or more holes 802
may be longitudinally spaced apart by distance d.sub.o. Two or more
of holes 802 may be circumferentially spaced apart by arc length
c.sub.o. Two or more of holes 802 may be offset from longitudinal
member 246 centerline CL.sub.o by arc length .eta..sub.o. One or
more of parameters w.sub.o, .delta..sub.o, r.sub.o, d.sub.o,
c.sub.o, .eta..sub.o, and any other suitable parameters, may be
configured to cooperate with one or more types of anchors. One or
more of parameters w.sub.o, .delta..sub.o, r.sub.o, d.sub.o,
c.sub.o, .eta..sub.o, and any other suitable parameters, may be
configured to cooperate with one or more types of anchors and one
or more of corresponding parameters w.sub.i, .delta..sub.o,
r.sub.i, d.sub.i, c.sub.i, .eta..sub.i (shown in FIG. 10).
[0108] FIG. 10 shows holes 1002 in wall thickness w.sub.i of distal
end 154. One or more of holes 1002 may be tapered at angle
.delta..sub.i relative to normal direction N.sub.i. One or more of
holes 1002 may have a radius r.sub.i. Two or more holes 802 may be
longitudinally spaced apart by distance d.sub.i. Two or more of
holes 1002 may be circumferentially spaced apart by arc length
c.sub.i. Two or more of holes 1002 may be offset from longitudinal
member 256 centerline CL.sub.i by arc length .eta..sub.i. One or
more of parameters w.sub.i, .delta..sub.i, r.sub.i, d.sub.i,
c.sub.i, .eta..sub.i, and any other suitable parameters, may be
configured to cooperate with one or more types of anchors. One or
more of parameters w.sub.i, .delta..sub.i, r.sub.i, d.sub.i,
c.sub.i, .eta..sub.i, and any other suitable parameters, may be
configured to cooperate with one or more types of anchors and one
or more of corresponding parameters w.sub.o, .delta..sub.o,
r.sub.o, d.sub.o, c.sub.o, .eta..sub.o (shown in FIG. 9).
[0109] One or more of holes 240 and 250 (shown in FIG. 2) may have
one or more parameter or feature that is similar to one or more of
the parameters and features discussed in connection with holes 802
and 1002.
[0110] FIG. 11 shows outer sleeve 140 and inner sleeve 150 with
angle .gamma. (shown in FIG. 6) at approximately 0.degree.. Outer
holes 802 are offset from longitudinal member 246 (shown in FIG. 3)
centerline CL.sub.o by arc length .eta..sub.o. Inner holes 1002 are
offset from longitudinal member 256 (shown in FIG. 3) centerline
CL.sub.i by arc length .eta..sub.i.
[0111] One or more of holes 240, 340, 802 and 1002 may have any
suitable shape. Each of proximal and distal ends of outer sleeve
140 and inner sleeve 150 may include holes of different sizes,
parameters and features.
[0112] Inner and outer holes may be sized or shaped differently to
reduce or relieve angular stress between sleeve 140 and sleeve 150
when sleeves 140 and 150 are angularly locked relative to each
other.
[0113] FIG. 12 shows rod 100 in intramedullary cavity IS' within
bone B', which may be a femur or other long bone. Bone B' is
fractured at fracture F'. Delivery cannula 1200 may provide a
curved entry path into cavity IS' through hole H' in bone B'.
[0114] Delivery cannula 1200 may be used to rotate outer sleeve 140
relative to inner sleeve 150 to make rod 100 rigid or partially
rigid. For example, cannula 1200 may engage the proximal end of
outer sleeve 140. A control shaft (not shown) may extend through
cannula 1200 and engage inner sleeve 150. The control shaft may
rotate inner sleeve 150 relative to outer sleeve 140. The control
shaft and cannula 1200 may then be disengaged from rod 100.
[0115] Anchors 1202 lock outer sleeve 140 and inner sleeve 150
rotationally with respect to each other. Anchors 1202 also secure
rod 100 to bone B'.
[0116] In some embodiments, cannula 1200 may be disengaged after
the inner and outer sleeves are rotationally locked. In some
embodiments, cannula 1200 may be disengaged after the inner and
outer sleeves are anchored to bone B'.
[0117] In some embodiments, the rod inner or outer sleeves may
include more than one pair of longitudinal members. For example, an
inner or outer sleeve may include two pairs of longitudinal
members.
[0118] FIG. 13 shows illustrative cut-pattern 1300 for a sleeve
such as outer sleeve 140 (shown in FIG. 1). Pattern 1300 may be a
laser-cut pattern. Pattern 1300, which is shown flat for
illustration, may be cut in a cylindrical tube to provide
compression relief on one side of the tube and relief on the other
side of the tube. Pattern 1300 may include cut arrangement 1302
having length L.sub.1. Pattern 1300 may include cut arrangement
1304 having length L.sub.2. Lengths L.sub.1 and L.sub.2 may be any
suitable length and may be the same as each other or different from
each other. Regions 1306 and 1308 may correspond to longitudinal
members such as 246 and 248 (shown in FIG. 3), respectively.
[0119] FIGS. 14 and 15 illustrate principles of an intramedullary
rod that includes an inner elongated member and an outer tubular
member. The rod may be fixed in a rigid state that includes one or
more straight sections and one or more curved sections.
[0120] FIG. 14 shows schematically illustrative segment 1400 that
may be one of a chain of segments (not shown) in an inner elongated
member of an intramedullary rod. Segment 1400 may have proximal end
1402 that is spaced apart from distal end 1404. Longitudinal axis
Ls may extend at least from proximal end 1402 through distal end
1404. Pivot axis 1406 at proximal end 1402 and pivot axis 1408 at
distal end 1404 are axes about which segment 1400 may move relative
to a proximal neighboring segment and a distal neighboring segment,
respectively.
[0121] Projection P.sub.dp is the projection of distal pivot axis
1408 onto proximal end 1402. Distal pivot axis 1408 is offset,
about axis Ls, from proximal pivot axis 1406, by angle .phi.. .phi.
may be any suitable angle from about 0.degree. to about
90.degree..
[0122] An intramedullary rod may include the segment chain and an
outer sleeve. The segment chain may be placed inside the outer
sleeve. The outer sleeve may be provided with stress relief
features that are distributed along the length and circumference of
the sleeve. In a first relative orientation of the chain and the
outer sleeve, the stress relief features may align with one or both
of the pivot axes and the rod may be bendable about the aligned
axes.
[0123] In a second relative orientation of the chain and the outer
sleeve, the stress relief features may be nonaligned with respect
to one or both of the pivot axes and the rod may be rigid about the
nonaligned axes and curved based on curvature (not shown) within
segment 1402 along axis Ls. The curvature may be any suitable
curvature.
[0124] FIG. 15 shows schematically illustrative segment 1500 that
may be one of a chain of segments (not shown) in an inner elongated
member of an intramedullary rod. Segment 1500 may have proximal end
1502 that is spaced apart from distal end 1504. Longitudinal axis
L.sub.t may extend at least from proximal end 1502 through distal
end 1504. Pivot axis 1506 at proximal end 1502 and pivot axis 1508
at distal end 1504 are axes about which segment 1500 may move
relative to a proximal neighboring segment and a distal neighboring
segment, respectively.
[0125] Distal pivot axis 1508 is offset, about transverse axis
L.sub.tt, from proximal pivot axis 1506, by angle .rho.. .rho. may
be any suitable angle from about 0.degree. to about 90.degree.. A
chain of segments such as 1500, along with an outer sleeve with
suitable stress relief, may be used to provide an intramedullary
rod that is flexible in a first configuration, but rigid--and
curved--in a second configuration. The rod may be rigid and curved
by angle .rho. in conjunction with any curvature that may be
present in segment 1500 along axis L.sub.t.
[0126] Compound segments may have proximal and distal pivot axes
that are offset contemporaneously by an angle such as .phi. (shown
in FIG. 14) and an angle such as .rho..
[0127] An inner elongated member of an intramedullary rod may
include segments such as 1400, 1500, compound segments, and any
suitable combination that are embodied as separate articulating
chain links. An inner elongated member of an intramedullary rod may
include segments such as 1502, 1504 and compound segments that are
embodied as adjacent portions of a unitary member, such as one
formed from a laser-cut tube. The segments may be distributed along
the rod to provide flexibility for insertion into a bone and
straight or curved rigid sections to distribute stiffness in
conformance with bone anatomy. One or more of the segments that
provide curved rigid support may be used in conjunction with
apparatus for providing straight rigid support.
[0128] FIGS. 16-21 show illustrative features of embodiments that
may include rod sections that may have flexible and rigid curved or
bent states.
[0129] FIG. 16 shows illustrative rod 1600 in collarbone B.sub.c.
Rod 1600 may have one or features in common with rod 100. Rod 1600
may include one or more straight sections, such as section 1602.
Rod 1600 may include one or more curved sections, such as sections
1604, 1606 and 1608. Bone support 1610 may extend from distal end
1612 of rod 1600. Bone support 1610 may be fixed to one or more
bone fragments (not shown) in metaphysieal region M or epiphyseal
region E of bone Bc using any suitable anchors (not shown).
[0130] Rod 1600 may include outer tubular member 1614. Rod 1600 may
include an inner elongated member (not shown) that is disposed
inside outer tubular member 1614. The inner elongated member may
include segments that are configured to bend relative to
neighboring segments along one or more pivot axes.
[0131] Outer tubular member 1614 may have stress relief features
(not shown) that are distributed to cooperate with one or more of
the pivot axes to allow rod 1600 to flex during insertion through a
bone access hole (not shown) in bone B.sub.c. The bone access hole
may be at an angle with respect to axis LBC of bone B.sub.c. Outer
tubular member 1614 may have rigid features (not shown) that are
distributed to interfere with one or more of the pivot axes.
Rotation of outer tubular member 1614 relative to the inner
elongated member may cause rod 1600 to become rigid in a curved or
bent configuration to provide mechanical support to different
portions of bone B.sub.c.
[0132] FIG. 17 shows illustrative rod 1700, which may have one or
more features in common with rod 1600. Rod 1700 may include bone
support 1710 for supporting one or more bone fragments at a distal
end of bone B.sub.c. Rod 1700 may include bone support 1710 for
supporting one or more bone fragments at a proximal end of bone
B.sub.c. One or more of bone supports 1710 and 1720 may have one or
more features in common with bone support 1610 (shown in FIG.
16).
[0133] Rod 1700 may include outer tubular member 1714. Rod 1700 may
include an inner elongated member (not shown) that is disposed
inside outer tubular member 1714. The inner elongated member may
include segments that are configured to bend relative to
neighboring segments along one or more pivot axes.
[0134] Rod 1700 may include one or more straight sections such as
section 1702. Rod 1700 may include one or more curved or bent
sections such as sections 1704, 1706 and 1708.
[0135] FIG. 18 shows illustrative inner elongated member 1800.
Inner elongated member 1800 may include segments 1802. Segments
1802 may be connected by linkages 1804. Exemplary segment 1806 will
be discussed in connection with FIG. 19.
[0136] FIG. 19 shows exemplary segment 1806. Segment 1806 may
include body 1808. Segment 1806 may include male linkage member
1808 and female linkage member 1810 for linkage to neighboring
segments 1802 (shown in FIG. 18). Body 1808 may include clearances,
such as clearances 1814, 1816 and 1818, to reduce interference
between segment 1806 and neighboring segments 1802.
[0137] Male linkage member 1808 may define pivot axis L.sub.m for
articulation with neighboring segment 1801 (shown in FIG. 18).
Female linkage member 1812 may define pivot axis L.sub.f for
articulation with neighboring segment 1803. Pivot axes L.sub.m and
L.sub.f are oblique and define two different bending axes for inner
elongated member 1800. The corresponding outer tubular sleeve may
be configured, at a first angular position relative to inner
elongated member 1800, to permit bending about one or both of pivot
axes L.sub.m and L.sub.f. The outer tubular sleeve may be
configured, at a second angular position relative to inner
elongated member 1800, to prevent bending about one or both of
pivot axes L.sub.m and L.sub.f.
[0138] FIG. 20 shows angle .rho.', which corresponds to angle .rho.
(shown in FIG. 15). Angle .rho.', along with any curvature in the
body of segment 1806, may be the basis for rigid curvature when the
rod is in its rigid state.
[0139] FIG. 21 shows illustrative cut-pattern 2100 for an outer
tubular member such as 1614 (shown in FIG. 16). Pattern 2100 may be
a laser-cut pattern. Pattern 2100, which is shown flat for
illustration, may be cut in a cylindrical tube to provide stress
relief in different directions that is distributed along axis
L.sub.MD (shown projected onto cut-pattern 2100) of the outer
tubular member.
[0140] Patterns 2102 and 2104, which may be similar to patterns
1302 and 1304 (shown in FIG. 13), may allow bending about a first
axis that is normal to axis L.sub.MD (as shown, prior to
deformation). Patterns 2102 and 2104 may be separated by rigid
section 2106. Patterns 2108 and 2110 may allow helical bending
about axis L.sub.MD (as shown, prior to deformation). The helix
allowed by pattern 2108 may have an opposite sense of rotation from
that of pattern 2110.
[0141] Pattern 2112 may allow a high degree of bending about a
second axis that is normal to axis L.sub.MD (as shown, prior to
deformation). Pattern 2114 may allow a high degree of bending about
a third axis that is normal to axis L.sub.MD (as shown, prior to
deformation).
[0142] Patterns 2116 and 2118, which may be similar to cut patterns
2102 and 2104, may allow bending about a fourth axis that is normal
to axis LMD (as shown, prior to deformation). The fourth axis may
be angularly offset, about axis LMD, with respect to the first axis
(defined by cut patterns 2102 and 2104).
[0143] Processes in accordance with the principles of the invention
may include one or more features of the processes illustrated in
FIG. 22. The processes may involve the use of one or more of the
apparatus shown and described herein. Some steps of the processes
may be performed in an inpatient setting. Some steps of the
processes may be performed in an outpatient setting.
[0144] The steps of the processes may be performed in an order
other than the order shown and described herein. Some embodiments
of the invention may omit steps shown and described in connection
with the illustrative methods. Some embodiments of the invention
may include steps that are not shown and described in connection
with the illustrative methods.
[0145] FIG. 22 shows illustrative steps of process 2200 for
repairing a fracture. At step 2202, a practitioner may drill an
access hole at angle to a bone axis. At step 2204, the practitioner
may prepare an intramedullary space in the bone to receive a rod.
At step 2206, the practitioner may align inner and outer sleeves of
rod to make the rod flexible. At step 2208, the practitioner may
insert rod into the intramedullary space. At step 2210, the
practitioner may rotate the inner sleeve relative to the outer
sleeve or rotate the outer sleeve relative to the inner sleeve to
reduce or eliminate flexibility of the rod. At step 2212, the
practitioner may fix a rotational offset between sleeves. The
practitioner may fix the rotational offset by actuating a mechanism
that locks the sleeves with respect to each other, but does not
necessarily lock the rod to the bone. At step 2214, the
practitioner may anchor the rod distal end to the bone. At step
2216, the practitioner may apply tension to the rod. At step 2218,
the practitioner may anchor the rod proximal end to the bone.
[0146] Thus, apparatus and methods for fracture repair have been
provided. Persons skilled in the art will appreciate that the
present invention can be practiced by other than the described
embodiments, which are presented for purposes of illustration
rather than of limitation. The present invention is limited only by
the claims that follow.
* * * * *