U.S. patent application number 14/825545 was filed with the patent office on 2016-03-10 for implantable prostheses.
The applicant listed for this patent is Topsfield Medical GmbH. Invention is credited to Paul V. Fenton, J. Christopher Flaherty, Amory Adrian Gregory Martin.
Application Number | 20160067049 14/825545 |
Document ID | / |
Family ID | 45004808 |
Filed Date | 2016-03-10 |
United States Patent
Application |
20160067049 |
Kind Code |
A1 |
Flaherty; J. Christopher ;
et al. |
March 10, 2016 |
IMPLANTABLE PROSTHESES
Abstract
Prosthesis, tools and surgical methods treat joint instability
by avoiding loosening over time. A shoulder prosthesis includes a
humeral member with a humeral joint surface and a humeral fixation
member and a glenoid member comprising a glenoid body with a
glenoid joint surface, and a glenoid fixation member attaching the
glenoid body to a scapula. The glenoid fixation member may be
attached orthogonally to the scapula. A dampener may be included to
absorb loads that may loosen one or more components of the
prosthesis.
Inventors: |
Flaherty; J. Christopher;
(US, FL) ; Fenton; Paul V.; (Marblehead, MA)
; Martin; Amory Adrian Gregory; (Paris, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Topsfield Medical GmbH |
Berlin |
|
DE |
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|
Family ID: |
45004808 |
Appl. No.: |
14/825545 |
Filed: |
August 13, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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13699029 |
Nov 20, 2012 |
9132016 |
|
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PCT/US2011/038096 |
May 26, 2011 |
|
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14825545 |
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61348465 |
May 26, 2010 |
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Current U.S.
Class: |
623/19.13 |
Current CPC
Class: |
A61F 2002/30565
20130101; A61F 2002/4085 20130101; A61F 2/40 20130101; A61F 2/4014
20130101; A61F 2002/3067 20130101; A61F 2002/30062 20130101; A61F
2002/30736 20130101; A61F 2002/30092 20130101; A61F 2310/00359
20130101; A61F 2002/30433 20130101; A61F 2/30942 20130101; A61F
2/30749 20130101; A61F 2002/30578 20130101; A61F 2002/30635
20130101; A61F 2002/4666 20130101; A61F 2002/3007 20130101; A61F
2/4612 20130101; A61F 2002/4631 20130101; A61F 2002/30672 20130101;
A61F 2/30742 20130101; A61F 2002/30884 20130101; A61F 2002/484
20130101; A61F 2002/30878 20130101; A61F 2002/30563 20130101; A61F
2002/30471 20130101; A61F 2002/4022 20130101; A61F 2/4081 20130101;
A61F 2002/30579 20130101 |
International
Class: |
A61F 2/40 20060101
A61F002/40 |
Claims
1-20. (canceled)
21. An implantable shoulder prosthesis, comprising: a glenoid
member comprising: a glenoid joint surface; and at least one
glenoid fixation member attached to the glenoid member, the at
least one glenoid fixation member comprising an elongated arm
extending from the glenoid member to a location on a scapular
surface, said scapular surface comprising an anterior, posterior or
both anterior and posterior surface of the scapula.
22. The implantable shoulder prosthesis of claim 21, wherein the
glenoid member further comprises a medial surface opposite the
glenoid joint surface, the medial surface constructed and arranged
to contact a glenoid cavity of a mammalian scapula.
23. The implantable shoulder prosthesis of claim 22, wherein the
glenoid member comprises at least one projection from the medial
surface, the at least one projection comprising one or more
projections selected from the group consisting of: a fin; a pin; a
peg; and combinations thereof.
24. The implantable shoulder prosthesis of claim 21, wherein the
glenoid member comprises a material selected from the group of
materials consisting of: cobalt-chrome; titanium; stainless steel;
tantalum; polyethylene; silicon; nylon; and combinations
thereof.
25. The implantable shoulder prosthesis of claim 21, wherein the
glenoid member comprises a first portion and a second portion
connected together via a hinge.
26. The implantable shoulder prosthesis of claim 25, wherein the
hinge is constructed and arranged to prevent fracture of the
scapula.
27. The implantable shoulder prosthesis of claim 21, wherein the
glenoid joint surface of the glenoid member is constructed and
arranged to provide a bearing surface for a head portion of a
humerus.
28. The implantable shoulder prosthesis of claim 27, wherein the
head portion of the humerus is an artificial implant.
29. The implantable shoulder prosthesis of claim 21, wherein the
glenoid joint surface of the glenoid member is concave.
30. The implantable shoulder prosthesis of claim 21, wherein the
glenoid joint surface of the glenoid member is convex.
31. The implantable shoulder prosthesis of claim 21, further
comprising at least one attachment mechanism, the at least one
attachment mechanism constructed and arranged to secure the at
least one glenoid fixation member to the scapular surface.
32. The implantable shoulder prosthesis of claim 31, wherein the at
least one attachment mechanism comprises one or more attachment
mechanisms selected from the group consisting of: bone screw; molly
bolt; a screw; a machine screw; a nut; a lock nut; a rivet; a bolt;
a washer; and combinations thereof.
33. The implantable shoulder prosthesis of claim 21, wherein the at
least one glenoid fixation member is removably attached to the
glenoid member.
34. The implantable shoulder prosthesis of claim 21, wherein the at
least one glenoid fixation member comprises a first fixation member
and a second fixation member.
35. The implantable shoulder prosthesis of claim 34, wherein the
first fixation member is secured to the anterior surface of the
scapula and the second fixation member is secured to the posterior
surface of the scapula.
36. The implantable shoulder prosthesis of claim 35, wherein the
first and second fixation members each comprise at least one
attachment orifice constructed and arranged to receive an
attachment mechanism.
37. The implantable shoulder prosthesis of claim 36, wherein the at
least one attachment orifice of each of the first and second
fixation members is aligned with each other.
38. The implantable shoulder prosthesis of claim 37, further
comprising an attachment mechanism, wherein the attachment
mechanism is constructed and arranged to engage the at least one
attachment orifice of each of the first and second stabilizing
members to secure the first and second stabilizing members to the
opposing anterior and posterior surfaces of the scapula.
39. The implantable shoulder prosthesis of claim 21, wherein the at
least one glenoid fixation member comprises at least a rigid
portion and a non-rigid portion.
40. The implantable shoulder prosthesis of claim 21, wherein the
elongated arm of the at least one glenoid fixation member is
constructed and arranged to conform to the scapular surface.
41. The implantable shoulder prosthesis of claim 40, wherein the at
least one glenoid fixation member comprises a surface that
approximates the contour of the scapula.
42. The implantable shoulder prosthesis of claim 41, wherein
glenoid fixation surface is produced based on a patient image
produced by an imaging device selected from the group consisting
of: X-Ray; CT Scan; MRI, Nuclear Image; Ultrasound Image;
Electromagnetic Image; and combinations thereof.
43. The implantable shoulder prosthesis of claim 21, further
comprising at least one attachment element protruding from the at
least one glenoid fixation member.
44. The implantable shoulder prosthesis of claim 21, wherein the at
least one glenoid fixation member comprises at least one attachment
orifice constructed and arranged to receive an attachment
mechanism.
45. The implantable shoulder prosthesis of claim 44, further
comprising at least one attachment mechanism, wherein the at least
one attachment mechanism is constructed and arranged to engage the
at least one attachment orifice to secure the at least one glenoid
fixation member to the scapular surface.
46. The implantable shoulder prosthesis of claim 44, wherein the at
least one attachment orifice comprises a first attachment orifice
and a second attachment orifice.
47. The implantable shoulder prosthesis of claim 21, further
comprising glenoid bulking material for positioning between the
glenoid joint surface of the glenoid member and a mammalian glenoid
joint surface.
48. The implantable shoulder prosthesis of claim 21, further
comprising an attachment tool.
49. The implantable shoulder prosthesis of claim 48, wherein the
attachment tool comprises a tool selected from the group consisting
of: right angle screwdriver; powered tool; wrench; a tool with a
curvilinear handle; a tool with a malleable handle; and
combinations thereof.
50. The implantable shoulder prosthesis of claim 21, further
comprising a humeral implant.
51. The implantable shoulder prosthesis of claim 50, wherein the
humeral implant comprises a convex mating surface.
52. The implantable shoulder prosthesis of claim 50, wherein the
humeral implant comprises a concave surface.
53. The implantable shoulder prosthesis of claim 21, further
comprising a securing assembly constructed and arranged to attach
tissue to at least one glenoid fixation member.
54. The implantable shoulder prosthesis of claim 53, wherein the
tissue comprises rotator cuff tissue.
55. The implantable shoulder prosthesis of claim 53, wherein the
securing assembly is constructed and arranged to allow suture to
pass therethrough.
56. The implantable shoulder prosthesis of claim 53, wherein the
securing assembly comprises an element selected from the group
consisting of: a loop; a mesh; a Dacron mesh; and combinations
thereof.
Description
RELATED APPLICATION
[0001] This application is a continuation application of U.S.
patent application Ser. No. 13/699,029, filed on Nov. 20, 2012,
which is a US national-phase application under 35 USC 371 of PCT
Application No. PCT/US11/38096, filed on May 26, 2011, which claims
the benefit of U.S. Ser. No. 61/348,465, filed May 26, 2010, the
content of each being incorporated herein by reference in its
entirety.
FIELD OF THE APPLICATION
[0002] Embodiments of the present application relate generally to
implantable prostheses, and more particularly, to implantable
shoulder prostheses, methods of implanting shoulder prostheses and
surgical tools for implanting shoulder prostheses.
BACKGROUND
[0003] Many joints of the human body naturally articulate relative
to one another. Generally, the articulation surfaces of these
joints are substantially smooth and without abrasion. However,
joints, such as shoulder joints, undergo degenerative changes due
to a variety of causes, such as, disease, injury, exercise and
other strenuous activities, and various other issues. When these
degenerative changes become advanced, to the point of becoming
irreversible, such joints or portions thereof may need to be
replaced with one or more prosthetics.
[0004] In light of the degenerative changes found in shoulder
joints, various shoulder prosthetics of conventional design have
been proposed. However, conventional shoulder prosthetics and their
associated surgical components suffer from many disadvantages. For
example, glenoid components of conventional design are subject to
various types of load forces, such as, shear forces,
anterior/posterior forces, lateral/medial forces, and rotational
forces, which may cause notching and chipping of bone and/or
loosening of the implanted components, thereby reducing the
lifespan of the prosthetic. In addition, such load forces may
create a rocking moment causing glenoid components to cantilever,
which can further result in notching and chipping of bone and/or
separation of the glenoid component from the scapula. Furthermore,
the loosening of conventional shoulder prosthetics may pulverize,
grind, crush and deform portions of a scapula, for example, a
glenoid cavity of a scapula, which as a result, can prohibit the
replacement of a worn, damaged or non-functional shoulder
prosthetic. For these and other reasons, there is a need for
improved shoulder prosthetics.
SUMMARY
[0005] Embodiments of the present application are directed toward
implantable shoulder prostheses, methods of implanting shoulder
prostheses and surgical tools for implanting shoulder prostheses
that further address and reduce notching and chipping of bone and
component loosening associated with implantable shoulder
prosthetics. In particular, embodiments provide implantable
shoulder prostheses and methods of implantation that realize, among
other features, a dampening characteristic that reduces an applied
load force through the absorption and dissipation of said force.
Further embodiments provide, among other features, multiple
fixation members for attaching implantable shoulder prosthesis and
capabilities for attaching implantable shoulder prostheses to
multiple surfaces of a scapula. Still further embodiments provide
methods of manufacturing shoulder prosthesis including obtaining an
image of a patient, such as an image including the contours of a
patient's scapula, and manufacturing fixation members based on
these contours. Although embodiments may be described with
reference to shoulder prosthesis, joint components and methods for
implantation described herein are applicable to other joints, such
as hips, knees, elbows, wrists, digits and other joints. Patients
applicable to these prosthetics include humans and other mammals,
as well as other animalia.
[0006] In one aspect an implantable shoulder prosthesis comprises:
a humeral member comprising: a humeral body comprising a humeral
joint surface; and at least one humeral fixation member constructed
and arranged to attach the humeral body to a humeral bone; a
glenoid member comprising: a glenoid body comprising a glenoid
joint surface; and at least one glenoid fixation member constructed
and arranged to attach the glenoid body to a scapula; and a
dampener; wherein the humeral joint surface and the glenoid joint
surface are constructed and arranged to rotatably interface; and
wherein the dampener is constructed and arranged to absorb a load
force transferred to the at least one glenoid fixation member.
[0007] In some embodiments the implantable shoulder prosthesis is
constructed and arranged to be implanted in a two legged
mammal.
[0008] In some embodiments the humeral member comprises at least a
portion of the dampener.
[0009] In some embodiments the dampener comprises a first portion
and a second portion.
[0010] In some embodiments the at least one glenoid fixation member
comprises the dampener second portion.
[0011] In some embodiments the humeral joint surface surrounds the
glenoid joint surface such that movement of the humeral bone is at
least partially constrained in two directions.
[0012] In some embodiments the humeral joint surface is rotatably
connected to the glenoid joint surface such that the movement of
the humeral bone is fully constrained in one direction and at least
partially constrained along two axes.
[0013] In some embodiments the at least one humeral fixation member
comprises a projecting stem.
[0014] In some embodiments the at least one humeral fixation member
comprises a threaded projection.
[0015] In some embodiments the at least one humeral fixation member
comprises a finned projection.
[0016] In some embodiments the at least one humeral fixation member
is constructed and arranged to be secured within a humeral bone
[0017] In some embodiments the glenoid member comprises the
dampener.
[0018] In some embodiments the dampener comprises a first portion
and a second portion.
[0019] In some embodiments the humeral member comprises the
dampener second portion.
[0020] In some embodiments the glenoid joint surface surrounds the
humeral joint surface such that movement of the humeral bone is at
least partially constrained in two directions.
[0021] In some embodiments the glenoid joint surface is
concave.
[0022] In some embodiments the humeral joint surface is convex.
[0023] In some embodiments the glenoid joint surface is convex.
[0024] In some embodiments the humeral joint surface is
concave.
[0025] In some embodiments the at least one glenoid fixation member
extends into the scapula in a medial direction.
[0026] In some embodiments the at least one glenoid fixation member
comprises at least one rigid portion.
[0027] In some embodiments the at least one glenoid fixation member
comprises at least one flexible portion.
[0028] In some embodiments the at least one glenoid fixation member
comprises at least one rigid portion and at least one flexible
portion.
[0029] In some embodiments the at least one glenoid fixation member
is selected from the group consisting of: a fin, a pin, a peg and a
screw.
[0030] In some embodiments the at least one glenoid fixation member
extends medially along one or more of: the anterior surface of the
scapula and the posterior surface of the scapula.
[0031] In some embodiments the at least one glenoid fixation member
comprises at least one attachment orifice.
[0032] In some embodiments at least one attachment device
constructed and arranged to pass through the attachment orifice and
into the scapula.
[0033] In some embodiments the at least one attachment device is
selected from the group consisting of: a screw; a pin, a peg; a
fin; and combinations thereof.
[0034] In some embodiments at least one attachment mechanism, the
at least one attachment mechanism constructed and arranged to
secure the at least one glenoid fixation member to the scapula.
[0035] In some embodiments the at least one attachment mechanism
comprises a bone screw.
[0036] In some embodiments the at least one attachment mechanism
comprises a molly bolt.
[0037] In some embodiments the at least one attachment mechanism
comprises an attachment device selected from the group consisting
of: a screw; a machine screw; a nut; a lock nut; a rivet; a bolt; a
washer; and combinations thereof.
[0038] In some embodiments the dampener is positioned between the
glenoid joint surface and the scapula.
[0039] In some embodiments the dampener is positioned between the
at least one glenoid fixation member and the scapula.
[0040] In some embodiments the at least one glenoid fixation member
comprises one or more of a pin, a peg, a screw and a fin, and
wherein the dampener surrounds the at least one glenoid fixation
member.
[0041] In some embodiments the dampener is positioned between the
glenoid joint surface and the glenoid fixation member.
[0042] In some embodiments the glenoid member comprises a rigid
section, and the dampener is positioned between the glenoid joint
surface and the rigid section.
[0043] In some embodiments the at least one glenoid fixation member
comprises at least two glenoid fixation members and the dampener is
positioned between the glenoid joint surface and the at least two
glenoid fixation members.
[0044] In some embodiments the at least one glenoid fixation member
comprises a first rigid portion and a second rigid portion, and
wherein the dampener is positioned between the first rigid portion
and the second rigid portion.
[0045] In some embodiments the dampener is positioned between the
humeral joint surface and the at least one humeral fixation
member.
[0046] In some embodiments the dampener is positioned between the
at least one humeral fixation member and the humeral bone.
[0047] In some embodiments the dampener surrounds at least a
portion of the humeral fixation member.
[0048] In some embodiments the at least one humeral fixation member
comprises a first rigid portion and a second rigid portion, wherein
the dampener is positioned between the first rigid portion and the
second rigid portion.
[0049] In some embodiments the dampener comprises a compressible
material.
[0050] In some embodiments the dampener comprises a compressible
assembly.
[0051] In some embodiments the compressible assembly comprises a
pneumatic or hydraulic assembly.
[0052] In some embodiments the compressible assembly comprises a
fluid filled reservoir.
[0053] In some embodiments the dampener comprises a spring.
[0054] In some embodiments the spring is selected from the group of
springs consisting of: torsional, compression, constant force,
Belleville, and combinations thereof.
[0055] In some embodiments the dampener comprises bone bonding
material.
[0056] In some embodiments the bond bonding material is constructed
and arranged to secure the humeral member to the humeral bone.
[0057] In some embodiments the bone bonding material surrounds at
least a portion of the at least one humeral fixation member.
[0058] In some embodiments the bone bonding material secures the
glenoid member to the glenoid cavity of the scapula.
[0059] In some embodiments the bone bonding material surrounds at
least a portion of the at least one glenoid fixation member.
[0060] In some embodiments the bone bonding material comprises
elastomeric material.
[0061] In some embodiments the bone bonding material comprises
flexible bone cement.
[0062] In some embodiments the dampener comprises fill
material.
[0063] In some embodiments the fill material is positioned in a
space previously occupied by bone tissue.
[0064] In some embodiments the fill material comprises bone
cement.
[0065] In some embodiments the fill material comprises flexible
adhesive.
[0066] In some embodiments the flexible adhesive comprises
elastomeric adhesive.
[0067] In some embodiments the dampener is further constructed and
arranged to absorb a load force transferred to the at least one
humeral fixation member.
[0068] In some embodiments the load comprises a compressive
load.
[0069] In some embodiments the load comprises a torsional load.
[0070] In some embodiments the load comprises a relatively
continuous load.
[0071] In some embodiments the load comprises a dynamic load.
[0072] In some embodiments the dampener comprises a first dampening
portion and a second dampening portion.
[0073] In some embodiments the glenoid member comprises the first
dampening portion and the humeral member comprises the second
dampening portion.
[0074] In some embodiments the at least one glenoid fixation member
comprises a first glenoid fixation member and a second glenoid
fixation member and wherein the first dampening portion absorbs a
load transferred to the first glenoid fixation member, and the
second dampening portion absorbs a load transferred to the second
glenoid fixation member.
[0075] In some embodiments the first dampening portion has a
compression ratio greater than a compression ratio of the second
dampening portion.
[0076] In some embodiments first dampening portion has a
compression ratio equal to a compression ratio of the second
dampening portion.
[0077] In some embodiments the first dampening portion is
constructed and arranged to absorb a force applied in a first
direction and the second dampening portion is constructed and
arranged to absorb or reduce a force applied in a second
direction.
[0078] In some embodiments the first direction and the second
direction are different.
[0079] In another aspect an implantable shoulder prosthesis
comprises: a glenoid member comprising: a glenoid body comprising a
glenoid joint surface constructed and arranged to provide a bearing
surface for a head portion of a humerus; a first glenoid fixation
member constructed and arranged to attach the glenoid member to a
scapula; and a second glenoid fixation member comprising an
engageable attachment element constructed and arranged to further
attach the glenoid member to the scapula; wherein said second
glenoid fixation member attachment element is constructed and
arranged to be engaged at least twenty fours hours after
implantation of the shoulder prosthesis.
[0080] In some embodiments the implantable shoulder prosthesis is
constructed and arranged to be implanted in a two legged
mammal.
[0081] In some embodiments the first glenoid fixation member is
constructed and arranged to be engaged in a first internal portion
of the scapula.
[0082] In some embodiments the second glenoid fixation member is
constructed and arranged to be engaged in a second internal portion
of the scapula.
[0083] In some embodiments the first glenoid fixation member is
constructed and arranged to be engaged with the glenoid cavity of
the scapula.
[0084] In some embodiments the second glenoid fixation member is
constructed and arranged to be engaged with the glenoid cavity of
the scapula.
[0085] In some embodiments the second glenoid fixation member is
constructed and arranged to be engaged with one or more of: the
anterior surface of the scapula and the posterior surface of the
scapula.
[0086] In some embodiments the first glenoid fixation member is
constructed and arranged to be engaged with one or more of: the
anterior surface of the scapula and the posterior surface of the
scapula.
[0087] In some embodiments the second glenoid fixation member is
constructed and arranged to be engaged with the glenoid cavity of
the scapula.
[0088] In some embodiments the second glenoid fixation member is
constructed and arranged to be engaged with one or more of: the
anterior surface of the scapula and the posterior surface of the
scapula.
[0089] In some embodiments the first glenoid fixation member
comprises the second glenoid fixation member.
[0090] In some embodiments the attachment element comprises an
expandable member constructed and arranged to expand into bone.
[0091] In some embodiments the attachment element comprises an
expandable member constructed and arranged to expand at least a
portion of the first glenoid fixation member into bone.
[0092] In some embodiments the attachment element comprises an
extendable member constructed and arranged to extend into bone.
[0093] In some embodiments the attachment element is positioned
proximate the first glenoid fixation member.
[0094] In some embodiments the attachment element comprises an
expandable member constructed and arranged to expand into bone.
[0095] In some embodiments the attachment element comprises an
expandable member constructed and arranged to expand at least a
portion of the first glenoid fixation member into bone.
[0096] In some embodiments the attachment element comprises an
extendable member constructed and arranged to extend into bone.
[0097] In some embodiments the attachment element is positioned
within the first glenoid fixation member.
[0098] In some embodiments the attachment element comprises an
expandable member constructed and arranged to expand at least a
portion of the first glenoid fixation member.
[0099] In some embodiments the attachment element comprises an
extendable member constructed and arranged to extend beyond the
first glenoid fixation member and into bone.
[0100] In some embodiments the attachment element is an attachment
device selected from the group consisting of: a fin; a pin; a peg;
a screw; and combinations thereof.
[0101] In some embodiments the attachment element is constructed
and arranged to rotate to attach the glenoid member to the
scapula.
[0102] In some embodiments the attachment element is selected from
the group consisting of: a pin, a peg, a screw, a fin and
combinations thereof.
[0103] In some embodiments the attachment element comprises a
sharpened distal end.
[0104] In some embodiments the attachment element comprises a
proximal end constructed and arranged to removably engage with a
tool.
[0105] In some embodiments said proximal end comprises one or more
of a hexagonal shaped cavity, a slot, or two slots positioned
approximately ninety degrees from each other.
[0106] In some embodiments the attachment element comprises an
expandable portion.
[0107] In some embodiments an expansion tool construct and arranged
to operably expand said expandable portion.
[0108] In some embodiments the expansion tool comprises an
expandable balloon or an expandable cage.
[0109] In some embodiments the attachment element comprises a shape
modifiable portion constructed and arranged to change shape to
further attach the glenoid member to the scapula.
[0110] In some embodiments the shape modifiable portion comprises a
least a plastically deformable material.
[0111] In some embodiments the shape modifiable portion comprises
at least a shaped memory material.
[0112] In some embodiments the shape modifiable portion further
comprises at least a plastically deformable material, and wherein
the shaped memory material is constructed and arranged to deform
the plastically deformable material at least twenty four hours
after implantation of the shoulder prosthesis.
[0113] In some embodiments the attachment element is constructed
and arranged to further attach the glenoid member to the scapula in
the presence of a magnetic field.
[0114] In some embodiments the attachment element is constructed
and arranged to further attach the glenoid member to the scapula in
the presence of a temperature above body temperature.
[0115] In some embodiments the attachment element is constructed
and arranged to automatically further attach the glenoid member to
the scapula.
[0116] In some embodiments the attachment element is constructed
and arranged to continuously further attach the glenoid member to
the scapula.
[0117] In some embodiments the attachment element is constructed
and arranged to further attach the glenoid member to the scapula
based on a condition of the patient receiving the shoulder
prosthesis.
[0118] In some embodiments the patient condition is loosening of
the glenoid member.
[0119] In some embodiments the patient condition is the presence of
a void in a bone of the patient.
[0120] In some embodiments the patient condition is suspected
presence of a void in a bone of the patient.
[0121] In some embodiments the attachment element is biased with a
constant force.
[0122] In some embodiments the implantable shoulder prosthesis
further comprises an access port constructed and arranged for a
tool to pass therethrough,
[0123] In some embodiments the access port is constructed and
arranged to be accessed percutaneously.
[0124] In some embodiments the access port is constructed and
arranged to be accessed in a minimally invasive procedure.
[0125] In some embodiments the access port is constructed and
arranged to be accessed in an open surgical procedure.
[0126] In some embodiments the access port provides access to a
portion of the first glenoid fixation member.
[0127] In some embodiments the access port provides access to a
portion of the second glenoid fixation member.
[0128] In some embodiments the access port provides access to the
attachment element.
[0129] In some embodiments the access port comprises a mechanical
valve.
[0130] In some embodiments the mechanical valve is constructed and
arranged to removably engage with the tool.
[0131] In some embodiments the access port comprises a resealable
septum.
[0132] In some embodiments the septum is constructed and arranged
to be penetrated by the tool avoiding removal of septum
material.
[0133] In some embodiments the access port prevents biological or
other contamination from passing through said access port.
[0134] In some embodiments the access port further comprises a
transport tube wherein the tool can inject material through said
transport tube.
[0135] In some embodiments the transport tube is constructed and
arranged to have material delivered to a location between the
glenoid member and the scapula.
[0136] In some embodiments the transport tube is constructed and
arranged to have material delivered to a location selected from the
group consisting of: within the glenoid member; proximate the
glenoid member; and combinations thereof.
[0137] In some embodiments the transport tube is constructed and
arranged to have material delivered to one or more of the first
glenoid fixation member; the second glenoid fixation member; and
the attachment element.
[0138] In some embodiments the material is selected from the group
consisting of: adhesive; cement; saline; an agent such as a drug;
and combinations thereof.
[0139] In some embodiments the material is fill material.
[0140] In some embodiments the fill material is constructed and
arranged to expand at least a port of the glenoid member.
[0141] In some embodiments the fill material is constructed and
arranged to expand the attachment element.
[0142] In some embodiments the fill material is constructed and
arranged to fill a void in a bone.
[0143] In some embodiments the material is below body
temperature.
[0144] In some embodiments the material is above body
temperature.
[0145] In some embodiments the fill material transport tube of the
resealable septum provides an access port through which fill
material can be injected.
[0146] In some embodiments the implantable shoulder prosthesis
further comprises an access port constructed and arranged for a
tool to pass therethrough,
[0147] In some embodiments the access port comprises a resealable
septum.
[0148] In some embodiments the access port comprises a mechanical
valve.
[0149] In some embodiments the access port is constructed and
arranged to be accessed percutaneously.
[0150] In some embodiments the fill material comprises a material
selected from the group consisting of: adhesive, cement; and
combinations thereof.
[0151] In some embodiments the fill material is flexible.
[0152] In some embodiments the fill material is rigid.
[0153] In some embodiments the tool comprises fill material
constructed and arranged to fill a void in bone.
[0154] In some embodiments the first glenoid portion or the second
glenoid portion comprise an expandable member and the fill material
is constructed and arranged to expand the expandable member into
bone.
[0155] In some embodiments the fill material is selected from the
group consisting of: adhesive, cement, water, saline, antibiotics,
and combinations thereof.
[0156] In some embodiments a tool.
[0157] In some embodiments the tool comprises a sharpened tip.
[0158] In some embodiments the tip is a needle tip.
[0159] In some embodiments the tip is a screwdriver tip.
[0160] In some embodiments the tool is constructed and arranged to
inject material into or proximate the glenoid member.
[0161] In some embodiments said injected material is constructed
and arranged to fill a space.
[0162] In some embodiments the space is space previously occupied
by bone.
[0163] In some embodiments the injected material is selected form
the group consisting of: adhesive; cement; saline; an agent such as
a drug; and combinations thereof.
[0164] In some embodiments the material is delivered above body
temperature.
[0165] In some embodiments the material is delivered below body
temperature.
[0166] In some embodiments the tool is constructed and arranged to
engage the attachment element.
[0167] In some embodiments the tool is further constructed and
arranged to expand the attachment element.
[0168] In some embodiments the tool is further constructed and
arranged to modify the shape of the attachment element.
[0169] In some embodiments the tool is further constructed and
arranged to deliver energy to the attachment element.
[0170] In some embodiments the energy is selected from the group
consisting of: magnetic energy; thermal energy; and combinations
thereof.
[0171] In some embodiments the tool comprises a screwdriver.
[0172] In some embodiments the tool comprises a tip selected from
the group consisting of: hex head; slotted head; Phillips head; and
torque head.
[0173] In some embodiments the tip is sharp.
[0174] In some embodiments of the inventive concepts are directed
to a method of implanting a shoulder prosthesis configured in
accordance with embodiments described herein.
[0175] In another aspect an implantable shoulder prosthesis
comprises: a glenoid member comprising: a glenoid joint surface
that is constructed and arranged to provide a bearing surface for a
head portion of a humerus; and a glenoid fixation member
constructed and arranged to attach a scapula; a pressure sensing
system configured to measure a pressure between the glenoid member
and the scapula.
[0176] In some embodiments the scapula is within a two legged
mammal.
[0177] In some embodiments a dampener.
[0178] In some embodiments the glenoid joint surface is
concave.
[0179] In some embodiments the glenoid joint surface is convex.
[0180] In some embodiments the pressure sensing assembly comprises
a sensor.
[0181] In some embodiments the sensor is selected from the group
consisting of: a strain gauge; a force sensing resistor; a piezo
crystal; and combinations thereof.
[0182] In some embodiments the sensor is positioned between the
glenoid fixation member and the scapula.
[0183] In some embodiments the sensor is positioned on the surface
of the scapula.
[0184] In some embodiments the sensor is positioned on the glenoid
cavity.
[0185] In some embodiments the sensor is positioned on the anterior
and/or posterior surface of the scapula.
[0186] In some embodiments the sensor is positioned on an internal
portion of the scapula.
[0187] In some embodiments the pressure sensing system comprises a
communication subsystem, wherein the communication subsystem is
configured to generate a pressure sensor signal corresponding to
the pressure measured between the glenoid facing surface of the
glenoid member and a glenoid cavity of a scapula.
[0188] In some embodiments the communication subsystem comprises a
wireless communication element.
[0189] In some embodiments the wireless communication element
comprises a wireless transceiver operating on a frequency band
selected from the group consisting of: 30-300 kHz, 300-3000 kHz,
3-30 MHz, 30-300 MHz, 300-3000 MHz, 3-30 GHz and 30-300 GHz.
[0190] In some embodiments the at least one attachment member
comprises a pressure sensor, wherein the pressure sensor is
operationally coupled to the pressure sensing system.
[0191] In some embodiments a biasing mechanism, wherein the biasing
mechanism biases the pressure sensor in an outward direction from
the glenoid facing surface.
[0192] In some embodiments the outward direction is a medial
direction.
[0193] In some embodiments the biasing mechanism is a spring.
[0194] In some embodiments the biasing mechanism is selected from
the group consisting of: a rubber plug, a foam plug and a plastic
plug.
[0195] In another aspect an implantable shoulder prosthesis,
comprises: a glenoid member comprising: a glenoid joint surface;
and at least one glenoid fixation member attached to the glenoid
member, the at least one glenoid fixation member comprising an
elongated arm extending from the glenoid member to a location on a
scapular surface, said scapular surface comprising an anterior,
posterior or both anterior and posterior surface of the
scapula.
[0196] In some embodiments the implantable shoulder prosthesis is
constructed and arranged to prevent the scapula from fracture.
[0197] In some embodiments the implantable shoulder prosthesis is
implantable in a two legged mammal.
[0198] In some embodiments the implantable shoulder prosthesis is
implantable in a human being.
[0199] In some embodiments the implantable shoulder prosthesis is
constructed and arranged to be of a size for being implantable in a
human being.
[0200] In some embodiments the glenoid member further comprises a
medial surface opposite the glenoid joint surface.
[0201] In some embodiments the medial surface is constructed and
arranged to contact a glenoid cavity of a mammalian scapula.
[0202] In some embodiments the glenoid member comprises at least
one fin projecting from the medial surface.
[0203] In some embodiments the glenoid member comprises at least
one peg projecting from the medial surface.
[0204] In some embodiments the glenoid member comprises at least
one peg projecting from the medial surface.
[0205] In some embodiments the glenoid member comprises a material
selected from the group of materials consisting of: cobalt-chrome;
titanium; stainless steel; tantalum; polyethylene; silicon; nylon;
and combinations thereof.
[0206] In some embodiments the glenoid member comprises a laminated
construction.
[0207] In some embodiments said laminated construction comprises at
least two materials selected from the group of materials consisting
of: cobalt-chrome; titanium; stainless steel; tantalum;
polyethylene; silicon; nylon; plastic; elastomer; silicone; and
combinations thereof.
[0208] In some embodiments said laminated construction comprises at
least a compressible material and an incompressible material.
[0209] In some embodiments the glenoid member comprises a first
portion and a second portion, the first portion comprising the
glenoid joint surface and the second portion comprising a surface
opposite the glenoid joint surface.
[0210] In some embodiments the first portion is fixedly attached to
the second portion.
[0211] In some embodiments the first portion of the glenoid member
is a replaceable element.
[0212] In some embodiments the glenoid member comprises a first
portion and a second portion connected together via a hinge.
[0213] In some embodiments the hinge extends in a superior-inferior
direction.
[0214] In some embodiments the hinge extends in an
anterior-posterior direction.
[0215] In some embodiments the hinge is constructed and arranged to
allow a head of a humerus to dislocate prior to causing a fracture
in the implantable shoulder prosthesis or the scapula.
[0216] In some embodiments the first portion and the second portion
flex about a longitudinal axis of the hinge.
[0217] In some embodiments the hinge is positioned at a central
portion of the glenoid member.
[0218] In some embodiments the hinge comprises a rubber
material.
[0219] In some embodiments the hinge is constructed and arranged to
prevent fracture of the scapula.
[0220] In some embodiments the glenoid member comprises a first
portion, a second portion, a third portion and a fourth portion,
wherein each of the first through fourth portions are connected
together via a hinge.
[0221] In some embodiments the hinge comprises a first hinge
portion that extends in a superior-inferior direction and a second
hinge portion that extends in an anterior-posterior direction.
[0222] In some embodiments a torsional stiffness of the first hinge
portion is greater than a torsional stiffness of the second hinge
portion.
[0223] In some embodiments the glenoid joint surface of the glenoid
member is constructed and arranged to provide a bearing surface for
a head portion of a humerus.
[0224] In some embodiments the head portion of the humerus is an
artificial implant.
[0225] In some embodiments the glenoid joint surface of the glenoid
member is concave.
[0226] In some embodiments the glenoid joint surface of the glenoid
member is convex.
[0227] In some embodiments the glenoid joint surface of the glenoid
member comprises a concave cross section relative to a
superior-inferior direction of extension.
[0228] In some embodiments the humeral head surface of the glenoid
member comprises a concave cross section relative to an
anterior-posterior direction of extension.
[0229] In some embodiments the humeral head surface of the glenoid
member comprises a concave cross section relative to a
superior-inferior direction of extension and an anterior-posterior
direction of extension.
[0230] In some embodiments the at least one glenoid fixation member
is constructed and arranged to prevent the scapula from
fracture.
[0231] In some embodiments the at least one glenoid fixation member
is constructed and arranged to hold fractured portions of the
scapula together.
[0232] In some embodiments the at least one glenoid fixation member
is less than about 10 cm in length.
[0233] In some embodiments the at least one glenoid fixation member
is less than about 15 cm in length.
[0234] In some embodiments the at least one glenoid fixation member
is less than about 20 cm in length.
[0235] In some embodiments the at least one glenoid fixation member
comprises a material selected from the group of materials
consisting of: cobalt-chrome; titanium; stainless steel; tantalum;
polyethylene; silicon; nylon; and combinations thereof.
[0236] In some embodiments the glenoid member and the at least one
glenoid fixation member comprise materials each having a different
stiffness.
[0237] In some embodiments the implantable shoulder prosthesis is
at least one attachment mechanism, the at least one attachment
mechanism constructed and arranged to secure the at least one
glenoid fixation member to the scapular surface.
[0238] In some embodiments the at least one attachment mechanism
comprises a bone screw.
[0239] In some embodiments the at least one attachment mechanism
comprises a molly bolt.
[0240] In some embodiments the at least one attachment mechanism
comprises an attachment mechanism selected from the group
consisting of: a screw; a machine screw; a nut; a lock nut; a
rivet; a bolt; a washer; and combinations thereof.
[0241] In some embodiments the at least one attachment mechanism
comprises a material selected from the group of materials
consisting of: cobalt-chrome; titanium; stainless steel; tantalum;
polyethylene; silicone; nylon; and combinations thereof.
[0242] In some embodiments the at least one glenoid fixation member
is removably attached to the glenoid member.
[0243] In some embodiments the at least one glenoid fixation member
is attached to a central region of the glenoid side surface of the
glenoid member.
[0244] In some embodiments the at least one glenoid fixation member
is attached to an off-central region of the glenoid surface of the
glenoid member.
[0245] In some embodiments the at least one glenoid fixation member
is attached to an outer side surface of the glenoid member.
[0246] In some embodiments a side surface of the at least one
glenoid fixation member is aligned with an outer side surface of
the glenoid member.
[0247] In some embodiments the at least one glenoid fixation member
comprises a first fixation member and a second fixation member.
[0248] In some embodiments the first fixation member is secured to
the anterior surface of the scapula and the second fixation member
is secured to the posterior surface of the scapula.
[0249] In some embodiments the first and second fixation members
each comprise at least one attachment orifice constructed and
arranged to receive an attachment mechanism.
[0250] In some embodiments the at least one attachment orifice of
each of the first and second fixation members is aligned with each
other.
[0251] In some embodiments the implantable shoulder prosthesis is
an attachment mechanism, wherein the attachment mechanism is
constructed and arranged to engage the at least one attachment
orifice of each of the first and second stabilizing members to
secure the first and second stabilizing members to the opposing
anterior and posterior surfaces of the scapula.
[0252] In some embodiments the at least one glenoid fixation member
comprises at least a rigid portion.
[0253] In some embodiments the at least one glenoid fixation member
comprises at least a semi-rigid portion.
[0254] In some embodiments the at least one glenoid fixation member
comprises at least a flexible portion.
[0255] In some embodiments the at least one glenoid fixation member
comprises at least a rigid portion and a non-rigid portion.
[0256] In some embodiments the elongated arm of the at least one
glenoid fixation member is constructed and arranged to conform to
the scapular surface.
[0257] In some embodiments the scapula is a human scapula.
[0258] In some embodiments the at least one glenoid fixation member
is machined to approximate the contour of the scapula.
[0259] In some embodiments the at least one glenoid fixation member
is machined based on a patient image.
[0260] In some embodiments the patient image is selected from the
group consisting of: X-Ray; CtScan; MRI, Nuclear Image; Ultrasound
Image; Electromagnetic Image; and combinations thereof.
[0261] In some embodiments the at least one glenoid fixation member
comprises at least a rigid portion.
[0262] In some embodiments the at least one glenoid fixation member
comprises at least a flexible portion.
[0263] In some embodiments the at least one glenoid fixation member
comprises at least a malleable portion.
[0264] In some embodiments the at least a malleable portion is
constructed and arranged to be plastically deformed prior to
attaching the at least one glenoid fixation member to the
scapula.
[0265] In some embodiments the at least one glenoid fixation member
comprises a rubber coating.
[0266] In some embodiments the at least one glenoid fixation member
comprises a laminated construction.
[0267] In some embodiments said laminated construction comprises at
least two materials selected from the group of materials consisting
of: cobalt-chrome; titanium; stainless steel; tantalum;
polyethylene; silicon; nylon; plastic; elastomer; silicone; and
combinations thereof.
[0268] In some embodiments said laminated construction comprises at
least a compressible material and an incompressible material.
[0269] In some embodiments the implantable shoulder prosthesis has
at least one attachment element protruding from the at least one
glenoid fixation member.
[0270] In some embodiments the attachment element is integral with
the at least one glenoid fixation member.
[0271] In some embodiments the at least one glenoid fixation member
comprises at least one attachment orifice constructed and arranged
to receive an attachment mechanism.
[0272] In some embodiments the implantable shoulder prosthesis has
at least one attachment mechanism, wherein the at least one
attachment mechanism is constructed and arranged to engage the at
least one attachment orifice to secure the at least one glenoid
fixation member to the scapular surface.
[0273] In some embodiments the at least one attachment orifice
comprises a first attachment orifice and a second attachment
orifice.
[0274] In some embodiments the first attachment orifice and the
second attachment orifice are spaced apart from each other.
[0275] In some embodiments the at least one attachment orifice
comprises a screw hole.
[0276] In some embodiments the at least one attachment orifice
comprises a first attachment orifice and a second attachment
orifice, and wherein the elongated arm comprises first and second
arm portions that each extend from the elongated arm.
[0277] In some embodiments the first attachment orifice is
positioned along the first arm portion and the second attachment
orifice is positioned along the second arm portion.
[0278] In some embodiments a planar surface of the first arm
portion is offset from a planar surface of the second arm
portion.
[0279] In some embodiments the implantable shoulder prosthesis is
an adhesive material.
[0280] In some embodiments the adhesive material secures the at
least one fixation member to the scapular surface.
[0281] In some embodiments the implantable shoulder prosthesis is
at least one attachment mechanism, the at least one attachment
mechanism constructed and arranged to further secure the at least
one glenoid fixation member to the scapular surface.
[0282] In some embodiments the adhesive material secures the
glenoid member to a glenoid cavity of the scapula.
[0283] In some embodiments the adhesive resides between the second
surface and the glenoid cavity.
[0284] In some embodiments the glenoid member comprises at least
one projection extending from the second surface, and wherein the
adhesive surrounds the projection.
[0285] In some embodiments the adhesive material is a glue
material.
[0286] In some embodiments the adhesive material is a cement
material.
[0287] In some embodiments the implantable shoulder prosthesis is
at least one cushion member connected to the at least one glenoid
fixation member.
[0288] In some embodiments the at least one cushion member
comprises a material selected from the group consisting of: a foam
material; a rubber material; a plastic material; and combinations
thereof.
[0289] In some embodiments the glenoid member has an anterior end
and a posterior end, said prosthesis further comprising a
bioabsorbable constraint member extending from said glenoid member
anterior end or said glenoid member posterior end, wherein the
bioabsorbable constraint member bioabsorbs when present in a human
body.
[0290] In some embodiments the bioabsorbable constraint member
limits rotation of a humerus bone.
[0291] In some embodiments the bioabsorbable constraint member
increases rotational movement of the humerus bone in proportion to
the bioabsorption of the bioabsorbable constraint member.
[0292] In some embodiments the bioabsorbable constraint member
increases rotational movement of the humerus bone when the
bioabsorbable constraint member is bioabsorbed.
[0293] In some embodiments the bioabsorbable constraint member
bioabsorbed over a period of at least one week.
[0294] In some embodiments the bioabsorbable constraint member
bioabsorbs over a period of at least one month.
[0295] In some embodiments the bioabsorbable constraint member
bioabsorbs over a period of at least six months.
[0296] In some embodiments the bioabsorbable constraint member
comprises a first bioabsorbable portion and a second bioabsorbable
portion.
[0297] In some embodiments the first bioabsorbable portion and the
second bioabsorbable portion have different rates of
bioabsorption.
[0298] In some embodiments the implantable shoulder prosthesis is a
coating.
[0299] In some embodiments the coating is constructed and arranged
to promote tissue ingrowth and/or prevent wear.
[0300] In some embodiments the implantable shoulder prosthesis is
glenoid bulking material.
[0301] In some embodiments the bulking material is selected from
the group consisting of: bone; foam; plastic; cement; metal; and
combinations thereof.
[0302] In some embodiments the implantable shoulder prosthesis is a
support member attached on and/or near the glenoid cavity.
[0303] In some embodiments the implantable shoulder prosthesis is
an attachment tool.
[0304] In some embodiments the attachment tool comprises a right
angle screwdriver.
[0305] In some embodiments the attachment tool is powered.
[0306] In some embodiments the attachment tool comprises a
wrench.
[0307] In some embodiments the handle is a curvilinear handle.
[0308] In some embodiments the handle is malleable.
[0309] In some embodiments the implantable shoulder prosthesis is a
humeral implant.
[0310] In some embodiments the humeral implant comprises a convex
mating surface.
[0311] In some embodiments the humeral implant comprises a concave
surface.
[0312] In some embodiments the implantable shoulder prosthesis is a
securing assembly constructed and arranged to attach tissue to at
least one glenoid fixation member.
[0313] In some embodiments the tissue comprises rotator cuff
tissue.
[0314] In some embodiments the securing assembly is constructed and
arranged to allow suture to pass therethrough.
[0315] In some embodiments the securing assembly comprises a
loop.
[0316] In some embodiments the securing assembly comprises
mesh.
[0317] In some embodiments the mesh is Dacron mesh.
[0318] In another aspect a method of manufacturing an implantable
shoulder prosthesis comprises: providing a glenoid member having a
lateral facing surface and a medial facing surface; imaging a
topography of a scapula; and forming at least one stabilizing
member based on the topography of a scapula, wherein the at least
one stabilizing member is attached to the glenoid member.
[0319] In some embodiments the at least one stabilizing member
comprises an elongated arm extending from the glenoid member in a
direction transverse to the medial facing surface.
[0320] In some embodiments the imaging of the topography of a
scapula is performed by a magnetic resonance imaging system.
[0321] In some embodiments the imaging of the topography of a
scapula is performed by a computed tomography imaging system.
[0322] In some embodiments the imaging of the topography of a
scapula is performed by an imaging system selected from the group
consisting of: computed tomography; X-ray; NMR; MRI; ultrasound
imaging device; infrared imaging device; and combinations
thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
[0323] The foregoing and other objects, features and advantages of
the invention will be apparent from the more particular description
of preferred embodiments, as illustrated in the accompanying
drawings in which like reference characters refer to the same parts
throughout the different views. The drawings are not necessarily to
scale, emphasis instead being placed upon illustrating the
principles of the preferred embodiments.
[0324] FIG. 1A is an anterior facing environmental view of a left
shoulder joint;
[0325] FIG. 1B is a posterior facing environmental view of a left
shoulder joint;
[0326] FIG. 1C is a lateral/medial facing view of a scapula;
[0327] FIG. 2 is an anterior facing environmental view of an
implantable shoulder prosthesis comprising a dampener in accordance
with embodiments of the present invention;
[0328] FIG. 3A is a side view of an implantable shoulder prosthesis
comprising a dampener in accordance with embodiments of the present
invention, and FIG. 3B is an exploded side view of the implantable
shoulder prosthesis of FIG. 3A in accordance with embodiments of
the present invention;
[0329] FIG. 3C is a side view of an implantable shoulder prosthesis
comprising a replaceable glenoid joint surface in accordance with
embodiments of the present invention;
[0330] FIG. 4 is a side view of an implantable shoulder prosthesis
comprising a humeral prosthetic having a dampener in accordance
with embodiments of the present invention;
[0331] FIG. 5 is a side view of an implantable shoulder prosthesis
comprising a plurality of fixation members in accordance with
embodiments of the present invention;
[0332] FIG. 6a is a side view of an implantable shoulder prosthesis
comprising an articulating glenoid joint member in accordance with
embodiments of the present invention, and FIG. 6b is a side view of
the implantable shoulder prosthesis of FIG. 6a illustrating an
applied load force;
[0333] FIG. 7 is a top perspective view of an implantable shoulder
prosthesis comprising a dampening system in accordance with
embodiments of the present invention;
[0334] FIG. 8 is an anterior facing environmental view of an
implantable shoulder prosthesis comprising a dampener and an
extending glenoid fixation member, in accordance with embodiments
of the present invention;
[0335] FIGS. 9a and 9b are 3-dimensional views of an implantable
shoulder prosthesis in accordance with embodiments of the present
invention;
[0336] FIGS. 10a and 10b are top perspective views of an
implantable shoulder prosthesis in accordance with embodiments of
the present invention;
[0337] FIG. 11 is top perspective view of an implantable shoulder
prosthesis comprising a hinge in accordance with embodiments of the
present invention;
[0338] FIGS. 12a, 12b and 12c illustrate a plurality of hinge
configurations of the glenoid joint surface of the implantable
shoulder prosthesis of FIG. 11 in accordance with embodiments of
the present invention;
[0339] FIGS. 13a and 13b are top perspective views of an
implantable shoulder prosthesis in accordance with embodiments of
the present invention;
[0340] FIG. 14 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present
invention;
[0341] FIG. 15 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present
invention;
[0342] FIG. 16 is an anterior facing environmental view of an
implantable shoulder prosthesis in accordance with embodiments of
the present invention;
[0343] FIG. 17 is an anterior facing environmental view of a
constrained implantable shoulder prosthesis comprising a dampener
in accordance with embodiments of the present invention;
[0344] FIG. 18 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present
invention;
[0345] FIG. 19 is a top perspective view of an implantable shoulder
prosthesis and surgical tools for implanting the shoulder
prosthesis in accordance with embodiments of the present
invention;
[0346] FIG. 20 is a top perspective view of a constrained
implantable shoulder prosthesis in accordance with embodiments of
the present invention;
[0347] FIG. 21 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present
invention;
[0348] FIGS. 22a and 22b are cross-sectional views of a glenoid
member having expandable glenoid fixation members in accordance
with embodiments of the present invention;
[0349] FIGS. 23a, 23b, 23c and 23d are cross-sectional views of a
glenoid member having expandable glenoid fixation members in
accordance with embodiments of the present invention;
[0350] FIG. 24 is a top perspective view of an implantable shoulder
prosthesis comprising a plurality of glenoid fixation members each
having an access port through which an adhesive material can be
added in accordance with embodiments of the present invention;
[0351] FIGS. 25a, 25b and 25c are top perspective views of an
implantable shoulder prosthesis comprising a plurality of glenoid
fixation members in which subsets of the plurality of glenoid
fixation members are engaged during separate procedures in
accordance with embodiments of the present invention;
[0352] FIG. 26 is a block diagram of a pressure sensing system in
accordance with embodiments of the present invention;
[0353] FIG. 27 is a flow diagram illustrating a method of operating
a pressure sensing system in accordance with embodiments of the
present invention;
[0354] FIG. 28 is a top perspective view of an implantable shoulder
prosthesis comprising a pressure sensing system in accordance with
embodiments of the present invention;
[0355] FIG. 29 is a lateral/medial facing view of a scapula
illustrating pressure sensor locations in accordance with
embodiments of the present invention;
[0356] FIG. 30 is a top perspective view of an implantable shoulder
prosthesis comprising a plurality of access ports through which an
adhesive material can be added in accordance with embodiments of
the present invention.
DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS
[0357] Embodiments of the invention are described more fully
hereinafter with reference to the accompanying drawings, in which
exemplary embodiments of the invention are shown. The present
invention may, however, be embodied in many different forms and
should not be construed as limited to the example embodiments set
forth herein. Rather, these exemplary embodiments are provided so
that this disclosure will be thorough and complete. In the
drawings, the sizes and relative sizes of objects may be
exaggerated for clarity.
[0358] It will be understood that when an element or object is
referred to as being "on," "connected to" or "coupled to" another
element or object, it can be directly on, connected or coupled to
the other element or object, or intervening elements or objects may
be present. In contrast, when an element is referred to as being
"directly on," "directly connected to" or "directly coupled to"
another element or object, there are no intervening elements or
objects present. As used herein, the term "and/or" includes any and
all combinations of one or more of the associated listed items.
[0359] It will be understood that, although the terms first,
second, etc. are used herein to describe various elements, these
elements should not be limited by these terms. These terms are used
to distinguish one element from another. For example, a first
element could be termed a second element, and, similarly, a second
element could be termed a first element, without departing from the
scope of the present invention. As used herein, the term "and/or"
includes any and all combinations of one or more of the associated
listed items.
[0360] The terminology used herein is for the purpose of describing
particular embodiments only and is not intended to be limiting of
the present invention. As used herein, the singular forms "a," "an"
and "the" are intended to include the plural forms as well, unless
the context clearly indicates otherwise. It will be further
understood that the terms "comprises" and/or "comprising," when
used in this specification, specifically the presence of stated
features, integers, steps, operations, elements, and/or components,
but do not preclude the presence or addition of one or more other
features, integers, steps, operations, elements, components, and/or
groups thereof.
[0361] FIG. 1a is an anterior facing environmental view of a
shoulder joint, FIG. 1b is a posterior facing environmental view of
a shoulder joint, and FIG. 1c is a lateral/medial facing view of a
scapula. In human anatomy, a shoulder joint comprises the part of
the body where a humeral bone (i.e., humerus) attaches to a
shoulder blade (i.e., scapula). The humerus comprises a humeral
head portion that interfaces with a glenoid cavity of a scapula,
such that the humerus articulates with respect to the glenoid
cavity of the scapula. The scapula forms the posterior located part
of the shoulder girdle.
[0362] For purposes of the present disclosure, the terms "sagittal
plane" and the like, when referring to portions of the human body,
refers to an imaginary plane that travels vertically from the top
to the bottom of the body, dividing the body into left and right
portions.
[0363] For purposes of the present disclosure, the terms "coronal
plane", "frontal plane" and the like, when referring to portions of
the human body, refers to an imaginary plane that travels
vertically from the top to the bottom of the body, dividing the
body into anterior and posterior (e.g., belly and back)
portions.
[0364] For purposes of the present disclosure, the terms "medial",
"medial direction" and the like, when referring to anatomical terms
of direction, refers to a direction that is transverse to the
sagittal plane of a human body, and that extends in a direction
toward the sagittal plane of a human body.
[0365] For purposes of the present disclosure, the terms "lateral",
"lateral direction" and the like, when referring to anatomical
terms of direction, refers to a direction that is transverse to the
sagittal plane of a human body, and that extends in a direction
away from the sagittal plane of a human body.
[0366] For purposes of the present disclosure, the terms
"superior/inferior", "superior/inferior direction" and the like,
when referring to anatomical terms of direction, refers to a
direction that extends in upward and downward directions, through a
superior angle of a scapula and an inferior angle of a scapula.
[0367] For purposes of the present disclosure, the terms
"superior", "superior direction" and the like, when referring to
anatomical terms of direction, refers to a direction that extends
upward, through a superior angle of a scapula.
[0368] For purposes of the present disclosure, the terms
"inferior", "inferior direction" and the like, when referring to
anatomical terms of direction, refers to a direction that extends
downward, through an inferior angle of a scapula.
[0369] FIG. 2 is an anterior facing environmental view of an
implantable shoulder prosthesis comprising a dampener in accordance
with embodiments of the present invention. A shoulder prosthesis
100 can comprise a glenoid member 101 having a glenoid joint member
103 and at least one glenoid fixation member 106.
[0370] The glenoid fixation member 106 can be constructed and
arranged to attach the glenoid member 101 to a glenoid cavity of a
scapula 110. For example, the glenoid fixation member 106 can
extend from a medial face 122 of the glenoid member 101 in a medial
direction MD, and may comprise a fin, a pin, a peg or a screw.
Further, the glenoid fixation member 106 can be integral with the
glenoid member 101, or may be a separate piece connected thereto.
The glenoid fixation member 106 or portions thereof can be
surrounded by a dampening material 108, which can absorb and
dissipate an applied load force, thus reducing notching and
chipping of bone and component loosening associated with the
implantable shoulder prosthesis 100. in some embodiments, glenoid
fixation member 106 is 10 cm, 15 cm, or 20 cm in length.
[0371] In one embodiment, a fin, such as a glenoid fin known to
those of skill in the art, can be used to attach the glenoid member
101 to a scapula 110. In another embodiment, a pin, such as a
glenoid pin known to those of skill in the art, can be used to
attach the glenoid member 101 to a scapula 110. In another
embodiment, a peg, such as a glenoid peg known to those of skill in
the art, can be used to attach the glenoid member 101 to a scapula
110. In another embodiment, a screw, such as a glenoid screw known
to those of skill in the art, can be used to attach the glenoid
member 101 to a scapula 110.
[0372] The glenoid member 101 can further comprise a dampener 104,
which is constructed and arranged to absorb a load force 116
transferred to the glenoid fixation members 106. In one embodiment,
the dampener 104 absorbs a load force 116 applied to a glenoid
joint surface 102 of the glenoid joint member 103, such that, a
reduced load force is transferred to the glenoid fixation members
106. As a result of the dampening of the load force 116, notching
and chipping of bone and component loosening associated with the
implantable shoulder prosthesis 100 is reduced.
[0373] The dampener 104 may comprise a compressible material, for
example, a rubber compound, plastic compound, a foam material, a
silicon material and the like. The dampener 104 can further
comprise a bone bonding material, which can be used to secure the
glenoid joint member 103 to a glenoid cavity of a scapula 110. In
one embodiment, the bone bonding material can comprise an
elastomeric material. In another embodiment, the bone bonding
material can comprise a flexible cement, such as the flexible bone
composite disclosed in U.S. Ser. No. 11/148,193, filed on Jun. 9,
2005, by Kerr, et al., the content of which is incorporated herein
by reference. In addition, the bone bonding material can be used to
attach various components of a shoulder prosthesis to a humeral
bone or a scapula 110.
[0374] The glenoid joint surface 102 of the glenoid joint member
103 can be constructed and arranged provide a bearing surface for a
head portion 120 of a humeral member 118. The head portion 120 can
comprise an artificial humeral head prosthetic or a humeral head of
a human humeral bone.
[0375] In one embodiment, the glenoid joint surface 102 of the
glenoid joint member 103 is concave, such that, the glenoid joint
surface 102 is constructed and arranged to interface with a convex
humeral joint surface of a head portion 120 of a humeral member
118. In another embodiment, the glenoid joint surface 102 of the
glenoid joint member is convex, such that, the glenoid joint
surface 102 is constructed and arranged to interface with a concave
humeral joint surface of a head portion 120 of a humeral member 118
(e.g., reverse shoulder prosthetic). In these embodiments, the
humeral member 118 can comprise a humeral bone of a human being or
an artificial humeral prosthetic, or combination thereof.
[0376] In some embodiments, prosthesis 100 can include a coating,
not shown but typically on one or more portions of prosthesis 100
outer surface. The coating can be selected from the group
consisting of: a lubricous, an anti-rejection agent, an
anti-inflammatory agent, an anti-bacterial coating; and
combinations of these. Additionally, one or more coatings can be
included to promote bone ingrowth and/or prevent wear.
[0377] FIG. 3a is a side view of an implantable shoulder prosthesis
comprising a dampener in accordance with embodiments of the present
invention, and FIG. 3b is an exploded side view of the implantable
shoulder prosthesis of FIG. 3a in accordance with embodiments of
the present invention. In one embodiment, a glenoid member 101 of a
shoulder prosthesis 100 comprises a glenoid joint member 103 and a
dampener 104 having a first dampening portion 124 and a second
dampening portion 126.
[0378] In one embodiment, the first dampening portion 124 comprises
a compression ratio greater than a compression ratio of the second
dampening portion 126. In another embodiment, the first dampening
portion 124 comprises a compression ratio less than a compression
ratio of the second dampening portion 126. In another embodiment,
the first dampening portion 124 comprises a compression ratio equal
to a compression ratio of the second dampening portion 126.
[0379] The first dampening portion 124 and the second dampening
portion 126 may comprise a compressible material, for example, a
rubber compound, plastic compound, a foam material, a silicon
material and the like. In one embodiment, the first dampening
portion 124 comprises a compressible material different from a
material of the second dampening portion 126.
[0380] The shoulder prosthesis 100 may further comprise a glenoid
fixation member 106 that is constructed and arranged to attach the
glenoid member 101 to a scapula 110. In this embodiment, the
glenoid fixation member 106 comprises a rotatable anchor; however,
other types glenoid fixation members 106 may be used to attach the
glenoid member 101 to a scapula 110.
[0381] FIG. 3c is a side view of an implantable shoulder prosthesis
comprising a replaceable glenoid joint surface in accordance with
embodiments of the present invention. In this embodiment, a glenoid
member 101 of a shoulder prosthesis 100 comprises a glenoid joint
member 103 that is removably attached to a rigid glenoid component
128. The glenoid joint member 103 can be attached to the rigid
glenoid component 128 by a screw 130. Other means for attaching the
glenoid joint member 103 to the rigid glenoid component can be
used, for example, hooks, clips, adhesives, engaging surfaces, and
the like. The glenoid member 101 may further comprise a dampener
104 positioned between the glenoid joint member 103 and the rigid
glenoid component 128. In this embodiment, the glenoid fixation
member 106 comprises a fin; however, other types glenoid fixation
members 106 may be used to attach the glenoid member 101 to a
scapula 110.
[0382] FIG. 4 is a side view of an implantable shoulder prosthesis
comprising a humeral prosthetic having a dampener in accordance
with embodiments of the present invention. A shoulder prosthesis
100 can comprise an implantable humeral head 402 adapted to
interface with a glenoid joint of a scapula. The glenoid joint can
comprise an implantable glenoid component or a glenoid cavity of a
human scapula.
[0383] In one embodiment, the humeral head 402 comprises a first
head portion 404 and a second head portion 406. The humeral head
402 can further comprise a dampener 104a connected between the
first head portion 404 and the second head portion 406 of the
humeral head 402. The humeral head 402 can be further connected to
a humeral stem 412 at a connection rod 414. In one embodiment, the
connection rod 414 comprises a dampener 104b.
[0384] The humeral stem 412 can be implanted in a humerus 118, and
secured therein with an adhesive material 410. In one embodiment,
the adhesive material 410 comprises a flexible dampening material,
an adhesive cement, an adhesive glue and the like.
[0385] In these embodiments, the dampeners 104a and 104b and the
dampening material 410 can reduce a load force transferred to a
glenoid joint of a scapula, thus reducing notching and chipping of
bone and component loosening associated with the implantable
shoulder prosthesis 100.
[0386] FIG. 5 is a side view of an implantable shoulder prosthesis
comprising a plurality of fixation members in accordance with
embodiments of the present invention. An implantable shoulder
prosthesis 100 can further comprise a glenoid member 101 and a
plurality of glenoid fixation members 106. The glenoid fixation
members can extend into a scapula 110 in a medial direction MD.
[0387] In this embodiment, the glenoid fixation member 106
comprises a spring 500, which is capable of absorbing and
dissipating an applied load force 116. In one embodiment, the
spring 500 is integral with the glenoid fixation member 106;
however, in other embodiments, the spring 500 can be separate from
the glenoid fixation member 106. As a result, the glenoid fixation
member 106 can comprise a rigid portion and a flexible portion.
[0388] FIG. 6a is a side view of an implantable shoulder prosthesis
comprising an articulating glenoid joint member in accordance with
embodiments of the present invention, and FIG. 6b is a side view of
the implantable shoulder prosthesis of FIG. 6a illustrating an
applied load force. An implantable shoulder prosthesis 100 can
comprise a glenoid joint member 103, a dampener 104 and a glenoid
fixation member 106. In this embodiment, the glenoid fixation
member 106 is a fin; however, other types glenoid fixation members
106 may be used to attach the glenoid member 101 to a scapula
110.
[0389] The glenoid joint member 103 can comprise a hinge arm 600
that is connected to the glenoid fixation member 106 at hinged pin
joint 602. In this embodiment, the dampener 104 is positioned
between the glenoid joint member 103 and the glenoid fixation
member 106 so as to absorb and dissipate an applied load force 116.
For example, referring to FIG. 6b, when a load force is applied
off-center to a glenoid joint surface 102 of the glenoid joint
member 103, a portion of the dampener 104 absorbs the applied load
force 116, allowing the glenoid joint member 103 to articulate with
respect to the hinged pin joint 602. As a result, a reduced load
force is transferred from the glenoid joint member 103 to the
glenoid fixation member 106.
[0390] FIG. 7 is a top perspective view (a view in an inferior
direction from a location superior to the patient's shoulder joint)
of an implantable shoulder prosthesis comprising a dampening system
in accordance with embodiments of the present invention. An
implantable shoulder prosthesis 100 can comprise a glenoid member
101 and a dampening system 701.
[0391] The dampening system 701 may comprise at least one piston
702 connected to a hydraulic or pneumatic assembly 704, which is
positioned between a medial face 122 of the glenoid member 101 and
a scapula 110. The dampening system 701 is constructed and arranged
to absorb and dissipate a load force 116, such as to the load force
shown in FIG. 6b, applied to a glenoid joint surface 102 of the
glenoid member 101.
[0392] In this embodiment, the dampening system 701 is surrounded
by a protective membrane 700. The protective membrane 700 can
comprise a compressible material, for example, a rubber compound,
plastic compound, a foam material, a silicon material and the like.
In some embodiments, the protective membrane 700 is further
constructed and arranged to absorb and dissipate a load force 116
that is applied to the glenoid joint surface 102 of the glenoid
member 101. In an alternative embodiment, a fluid filled reservoir
can be used as a shock absorbing assembly. In another alternative
embodiment, a spring can be used as a shock absorbing assembly,
such as a spring selected from the group consisting of: torsional,
compression, constant force, and/or Belleville springs.
[0393] FIG. 8 is an anterior facing environmental view of an
implantable shoulder prosthesis comprising a dampener in accordance
with embodiments of the present invention. A shoulder prosthesis
100 can further comprise a glenoid member 101 having at least one
stabilizing member 800 extending from the glenoid member 101 in a
medial direction MD. In another embodiment, the stabilizing member
800 extends from the glenoid member 101 in a direction that is
transverse to the medial face 122 of the glenoid member 101.
[0394] The stabilizing member 800 can comprise at least one
attachment orifice constructed and arranged to receive an
attachment mechanism 804, such as, a screw, bolt and washer, or
molly bolt. For example, the attachment mechanism 804 can pass
through the attachment orifice and into a scapula 110. When
engaged, the attachment mechanism 804 operates to secure the
stabilizing member. 800 to a lateral surface of a scapula 110. In
one embodiment, the lateral surface is an anterior surface of a
scapula 110. Alternatively or additionally, the lateral surface is
a posterior surface of a scapula 110.
[0395] In another embodiment, the stabilizing member 800 can
further comprise a Dacron or other biocompatible mesh material 806
for attaching rotator cuff muscles and tendons thereto. In another
embodiment, the stabilizing member 800 can further comprise a
suture clasp 802 or a plurality thereof for attaching rotator cuff
muscles and tendons thereto.
[0396] FIGS. 9a and 9b are 3-dimensional views of an implantable
shoulder prosthesis in accordance with embodiments of the present
invention. A shoulder prosthesis 100 can further comprise a glenoid
member 101 and at least one stabilizing member 800 attached
thereto. In this embodiment, the stabilizing member 800 is attached
to a central region of the medial face of the glenoid member 101. A
dampener, 104, may be positioned between glenoid member 101 and
stabilizing member 800 such as to absorb shock and/or allow flexing
of glenoid member 101 relative to stabilizing member 800.
[0397] The stabilizing member 800 can comprise an elongated arm
having at least one attachment orifice, such as at least one of
attachment orifice 812a or 812b positioned thereon, which is
constructed and arranged to receive an attachment mechanism, such
as a screw, bolt, rivet or other element for passing through
attachment orifice 812a or 812b and into scapula 110. When engaged,
the attachment mechanism operates to secure the stabilizing member
800 to a lateral surface of a scapula 110. In one embodiment, the
elongated arm of the stabilizing member 800 comprises both first
and second attachment orifices 812a and 812b, which are spaced
apart from each other as shown.
[0398] In one embodiment, attachment orifices 812a or 812b
comprises a non-threaded screw hole. In another embodiment,
attachment orifices 812a or 812b comprises a threaded screw
hole.
[0399] The elongated arm of the stabilizing member 800 can further
comprise a first arm portion 808 and a second arm portion 810. In
one embodiment, a first attachment orifice 812a is positioned along
the first arm portion 808 and a second attachment orifice 812b is
positioned along the second arm portion 810. In this embodiment, a
planar surface of the first arm portion 808 can be offset from a
planar surface of the second arm portion 810.
[0400] The implantable shoulder prosthesis 100 can further comprise
an adhesive material that secures the stabilizing member 800 to a
lateral surface of a scapula 110. The implantable shoulder
prosthesis 100 can further comprise an adhesive material that
secures the glenoid member 101 to a glenoid cavity of a scapula
110. The adhesive material can comprise a glue material, a cement
material, a bone bonding material or a combination thereof.
[0401] In one embodiment, the glenoid joint surface 102 of the
glenoid member 101 is concave, such that, the glenoid joint surface
102 is constructed and arranged to interface with a convex humeral
head portion of a humeral member. In another embodiment, the
glenoid joint surface 102 of the glenoid member 101 comprises a
concave cross section relative to a superior-inferior direction of
extension. In another embodiment, the glenoid joint surface 102 of
the glenoid member 101 comprises a concave cross section relative
to an anterior-posterior direction of extension. In another
embodiment, the glenoid joint surface 102 of the glenoid member 101
comprises a concave cross section relative to a superior-inferior
direction of extension and an anterior-posterior direction of
extension.
[0402] The stabilizing member 800 and the glenoid member 101 can
each comprise a material such as cobalt-chrome, titanium, stainless
steel, tantalum, polyethylene, silicon, nylon, polyester polymers
or a combination thereof. In one embodiment, the glenoid member 101
comprises a different material than the stabilizing member 800, and
in another embodiment, the glenoid member 101 and the stabilizing
member 800 comprise the same material. In another embodiment, the
glenoid member 101 and the stabilizing member 800 each comprise a
material having a different stiffness. Further, the stabilizing
member 800 can comprise a malleable material.
[0403] The stabilizing member 800 and the glenoid member 101 can
further comprise a laminated material. The laminated material can
comprise at least two materials, such as cobalt-chrome, titanium,
stainless steel, tantalum, polyethylene, silicon, nylon and
polyester polymers.
[0404] In another embodiment, the glenoid member 101 can comprise
autologous bone harvested from intra-oral sources of a human
patient. For example, the autologous bone can be harvested from an
iliac crest of a pelvis.
[0405] In another embodiment, the glenoid member 101 can comprise
allograft bone harvested from intra-oral sources of a different
human patient. For example, the allograft bone can be harvested
from an iliac crest of a pelvis.
[0406] In another embodiment, the glenoid member 101 can comprise
xenograft bone harvested from intra-oral sources of a bovine
species or a porcine species.
[0407] In addition, the stabilizing member 800 can be constructed
and arranged to conform to an anterior or posterior surface of a
scapula 110. In one embodiment, the stabilizing member 800 is
machined to conform to the contour of a patient's scapula 110. The
stabilizing member 800 can be machined according to an X-ray image,
CT scan, MRI, Nuclear image, Ultra sound image or combinations
thereof.
[0408] In an alternative embodiment, one or more extending members,
protrude from first arm portion 808 and/or second arm portion 810,
such as at the locations of attachment orifices 812a and 812b
respectively. These protrusions may be configured to attach to
scapula 110 and/or protrude into scapula 110.
[0409] FIGS. 10a and 10b are top perspective views of an
implantable shoulder prosthesis in accordance with embodiments of
the present invention. A shoulder prosthesis 100 can further
comprise a glenoid member 101 and first and second stabilizing
members 906, 908 attached thereto. In one embodiment, the first and
second stabilizing members 906, 908 are attached to an off-center
region of the medial face 122 of the glenoid member 101. In another
embodiment, the first and second stabilizing members 906, 908 are
attached to the medial face 122 of the glenoid member 101 such that
a side surface of each of the first and second stabilizing members
906, 908 is aligned with an outer side surface of the glenoid
member 101. Further, embodiments can comprise first and second
stabilizing members 906, 908 that can be removably attached to the
glenoid member 101.
[0410] The first and second stabilizing members 906, 908 can
comprise a material such as cobalt-chrome, titanium, stainless
steel, tantalum, polyethylene, silicon, nylon, polyester polymers,
other biocompatible materials, or a combination thereof.
[0411] The first and second stabilizing members 906, 908 can
further comprise at least one attachment orifice positioned
thereon, which is constructed and arranged to receive attachment
mechanisms 910a and 910b. When engaged, the attachment mechanisms
910a and 910b operate to secure the first and second stabilizing
members 906, 908 to lateral surfaces of a scapula 110.
[0412] The attachment mechanisms 910a and 910b can comprise a bone
screw, a molly bolt, a machine screw, a rivet or a bolt. The
attachment mechanisms 910a and 910b can be further secured by nuts
912a and 912b.
[0413] In addition, the attachment mechanisms 910a and 910b and
nuts 912a and 912b can comprise a material such as cobalt-chrome,
titanium, stainless steel, tantalum, polyethylene, silicone, nylon,
polyester polymers, other biocompatible materials, or a combination
thereof.
[0414] FIG. 11 is top perspective view of an implantable shoulder
prosthesis comprising a hinge in accordance with embodiments of the
present invention. Shoulder prosthesis 100 can further comprise a
glenoid member 101 having a hinge 904, which allows a head portion
of a humeral member to dislocate prior to stressing the glenoid
member 101 of the implantable shoulder prosthesis 100. The hinge
904 can comprise a material such as rubber, plastic, silicon and
the like.
[0415] FIGS. 12a, 12b and 12c illustrate a plurality of hinge
configurations of the glenoid joint surface of the implantable
shoulder prosthesis of FIG. 11 in accordance with embodiments of
the present invention.
[0416] Referring to FIG. 12a, the glenoid member 101 can comprise a
first-fourth portions connected together via a hinge 904. In this
embodiment, the hinge 904 comprises a first hinge portion, 904a,
that extends in a superior/inferior direction and a second hinge
portion 904b that extends in an anterior/posterior direction.
[0417] In one embodiment, a torsional stiffness of the first hinge
portion is greater than a torsional stiffness of the second hinge
portion. In another embodiment, a torsional stiffness of the first
hinge portion is less than or equal to a torsional stiffness of the
second hinge portion.
[0418] Referring to FIG. 12b, the glenoid member 101 can comprise
first and second portions connected together via hinge 904b. In
this embodiment, the hinge 904b extends in an anterior/posterior
direction, allowing the first and second portions of the glenoid
member to flex about a longitudinal axis of the hinge 904b.
[0419] Referring to FIG. 12c, the glenoid member 101 can comprise
first and second portions connected together via a hinge 904a. In
this embodiment, the hinge 904a extends in an superior/inferior
direction, allowing the first and second portions of the glenoid
member to flex about a longitudinal axis of the hinge 904a.
[0420] FIGS. 13a and 13b are top perspective views of an
implantable shoulder prosthesis in accordance with embodiments of
the present invention. A shoulder prosthesis 100 can further
comprise a glenoid member 101 and a stabilizing member 800, 906
having a dampener 104. In this embodiment, the dampener 104
positioned along the stabilizing member 800, 906, and is
constructed and arranged to absorb a load force 116 applied to the
glenoid joint surface 102 of the glenoid member 101 such that a
reduced load force is transferred to the attachment mechanisms 910a
and 910b and/or the glenoid cavity of a scapula 110. As a result of
the dampening of the load force 116, notching and chipping of bone
and component loosening associated with the implantable shoulder
prosthesis 100 is reduced.
[0421] FIG. 14 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present invention.
A shoulder prosthesis 100 can further comprise a glenoid member
101, at least one glenoid fixation member 106 and at least one
stabilizing member 906, 908. In this embodiment, the glenoid
fixation member 106 can be constructed and arranged to attach the
glenoid member 101 to a glenoid cavity of a scapula 110 and the
attachment mechanisms 910a and/or 910b operate to secure the at
least one stabilizing member 906, 908 to a lateral surface of a
scapula 110. Glenoid fixation members 106 may comprise pins,
screws, fins, keels or other scapular engagement elements.
[0422] FIG. 15 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present invention.
A shoulder prosthesis 100 can further comprise a glenoid member
101, a dampener 104 and first and second stabilizing members 906,
908.
[0423] FIG. 16 is an anterior facing environmental view of an
implantable shoulder prosthesis in accordance with embodiments of
the present invention. A shoulder prosthesis 100 can further
comprise a glenoid member 402 with a convex geometry, an optional
dampener 104 and a stabilizing member 800 having an enlarged
surface 800a. The enlarged surface 800a of the stabilizing member
800 can distribute applied forces such as to prevent the fracture
of a scapula bone 110.
[0424] Glenoid member 402 can comprise a material such as
cobalt-chrome, titanium, stainless steel, tantalum, polyethylene,
silicon, nylon, polyester polymers or a combination thereof. In
another embodiment, glenoid member 402 can comprise a dampening
portion and/or material.
[0425] The shoulder prosthesis 100 can further comprise a cushion
material 1000 connected to the stabilizing member 800, and
positioned between the stabilizing member 800 and a surface of a
scapula 110. The cushion material 1000 can comprise a material such
as foam, rubber, plastic, silicon and the like.
[0426] FIG. 17 is an anterior facing environmental view of a
constrained implantable shoulder prosthesis comprising a dampener
in accordance with embodiments of the present invention. A shoulder
prosthesis 100 can further comprise a glenoid member 101, an
optional dampener 104 and a stabilizing member 800 having an
enlarged surface 800a. The enlarged surface 800a of the stabilizing
member 800 can distribute applied forces such as to prevent the
fracture of a scapula bone 110.
[0427] Glenoid member 101 can comprise a material such as
cobalt-chrome, titanium, stainless steel, tantalum, polyethylene,
silicon, nylon, polyester polymers or a combination thereof. In
another embodiment, glenoid member 101 can comprise a dampening
portion and/or material.
[0428] Glenoid member 101 is fixedly attached to a first end 3000a
of universal joint 3000. Universal joint 3000 is fixedly attached
at a second end 3000b to prosthetic humeral head and stem 3001.
[0429] The shoulder prosthesis 100 can further comprise a cushion
material 1000 connected to the stabilizing member 800, and
positioned between the stabilizing member 800 and a surface of a
scapula 110. The cushion material 1000 can comprise a material such
as foam, rubber, plastic, silicon and the like.
[0430] FIG. 18 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present invention.
A shoulder prosthesis 100 can further comprise a glenoid member
101, a dampener 104 and a continuous scapular fixation member
950.
[0431] In this embodiment, the dampener 104 is positioned between
the glenoid member 101 and the scapular fixation member 950.
Dampener 104 may comprise a foam or other cellular material with a
rigidity constructed and arranged to allow glenoid member 101 to
deflect under high loads, such as to prevent dislocation of a
natural or artificial humeral head, and or prevent damage to
scapula 110. The scapular fixation member 950 is constructed and
arranged to conform to surfaces of a scapula 110. Such surfaces can
include an anterior surface, a posterior surface and a glenoid
surface of a scapula 110.
[0432] FIG. 19 is a top perspective view of an implantable shoulder
prosthesis and surgical tools for implanting the shoulder
prosthesis in accordance with embodiments of the present invention.
A shoulder prosthesis 100 can further comprise a glenoid assembly
951 comprising a glenoid member 101, a scapular fixation member 950
and a cushion material 1000.
[0433] The cushion material 1000 is positioned between the scapula
fixation member 950 and surfaces of a scapula 110, such that the
shoulder prosthesis 100 conforms to the contour of the scapula
110.
[0434] Also shown in FIG. 19 is tool 2500 comprising handle 2501,
ratchet assembly 2502 and engaging tip 2503. Tool 2500 is
constructed and arranged such that rotation of handle 2501 causes
ratchet assembly 2502 and tip 2503 to rotate. Tip 2503, such as a
Phillips, torx, hex or other fastener engaging tip is configured to
engage the head of attachment mechanism 910a and/or 910b.
[0435] Also shown in FIG. 19 is tool 2600 comprising handle 2601,
shaft 2602 and wrench end 2603. In a preferred embodiment, shaft
2602 is malleable such as to be shaped by a clinician during a
surgical implantation procedure. Wrench end 2603 is configured to
engage nut 912a and/or 912b such that rotation of attachment
mechanism 910a and/or 910b, respectively, prevents rotation of nut
912a and/or 912b. In an alternative embodiment, wrench end 2603 may
be constructed and arranged to rotate, such as via rotation of
handle 2601. In another alternative embodiment, tool 2500 and/or
tool 2600 may include torque or other force measurement feedback
such as to tighten attachment mechanisms 910a and/or 910b to nuts
912a and/or 912b, respectively, at a desired level of
compression.
[0436] FIG. 20 is a top perspective view of a constrained
implantable shoulder prosthesis in accordance with embodiments of
the present invention. A shoulder prosthesis 100 can further
comprise a constrained humeral cup 1308 that is constructed and
arranged to interface with an convex glenoid portion 1306.
[0437] Glenoid portion 1306 is attached to a scapular fixation
member 950 by a screw 1302 and a flexible membrane 1304. The
flexible membrane 1304 can comprise a compressible material, for
example, a rubber compound, plastic compound, a foam material, a
silicon material and the like, and is constructed and arranged to
absorb and dissipate a load force 116 that is applied to the
artificial humeral head 1306. In addition, the screw 1302 can
comprise a spring 1300 to further absorb and dissipate a load force
116 that is applied to the artificial humeral head 1306.
[0438] The constrained humeral cup 1308 is constructed and arranged
to limit movement of a humeral member. For example, the humeral cup
1308 can limit movement of humeral member in at least two
directions. In one embodiment, humeral cup 1308 surrounds greater
than 180 degrees of the glenoid portion 1306. In an alternative
embodiment, one or both ends of cup 1308 are constructed of
bioabsorbable material such that the constraint is time limited.
Duration of constraint may be selected to allow healing or other
physiologic processes to occur prior to full motion enabling of the
patient's shoulder joint. Typical duration times include periods
greater than one week, greater than one month, greater than 3
months and greater than 6 months.
[0439] FIG. 21 is a top perspective view of an implantable shoulder
prosthesis in accordance with embodiments of the present invention.
A shoulder prosthesis 100 can further comprise a concave humeral
cup 1402 that is constructed and arranged to interface with an
convex glenoid portion 1400. In this embodiment, glenoid portion
1400 is integral with the scapular fixation member 950.
[0440] FIGS. 22a and 22b are cross-sectional views of a glenoid
member 101 having expandable glenoid fixation members in accordance
with embodiments of the present invention. A shoulder prosthesis
100 can further comprise a glenoid member 101 having a plurality of
glenoid fixation members 106 that are expandable. An expandable
glenoid fixation member 106 comprises an outer screw portion 1500
and an inner expanding post 1502. The outer screw portion 1500
comprises threads 1501 for penetrating human bone, such as, a
scapula 110. The inner screw portion 1502 comprises threads 1503,
such that rotational movement of the inner screw portion 1502
operates to advance or retract the inner screw portion 1502 within
the outer screw portion 1500.
[0441] Referring to FIG. 22b, the advancement of the inner screw
portion 1502 within the outer screw portion 1500 controls the
expansion of the outer screw portion 1500. For example, when the
inner screw portion 1502 is advanced within the outer screw portion
1500, an expanded portion 1504 of the outer screw portion 1500 is
formed.
[0442] In this embodiment, the expansion of the outer screw portion
1500, as shown in the middle fixation member 106, can tighten a
glenoid fixation member 106 that has become loose and/or prevent
initial loosening.
[0443] FIGS. 23a, 23b, 23c and 23d are cross-sectional views of a
glenoid member having expandable glenoid fixation members in
accordance with embodiments of the present invention. A shoulder
prosthesis can further comprise a glenoid member 101 and an
expandable glenoid fixation member 106.
[0444] Referring to FIG. 23b, an expandable glenoid fixation member
106 can comprise a fin-type member 1602 having an expandable
portion 1603. A balloon tool 1604 can be used to expand the
fin-type member 1602, such as by expansion of a balloon portion
with a fluid. Alternatively or additionally, tool 1604 may comprise
an expandable cage, such as a nitinol cage expanded with heat, or
an assembly that expands due to applied magnetic forces.
[0445] Referring to FIG. 23c, an expandable glenoid fixation member
106 can comprise a fin-type member 1605 having a Nitinol coil 1606
positioned within an expandable portion 1603. A heated tip 1607 of
a heating tool 1608 can be used to expand the Nitinol coil 1606
which in turn expands portion 1603.
[0446] Referring to FIG. 23d, an expandable glenoid fixation member
106 can comprise a fin-type member 1609 having a sharp pin 1610. A
tool 1611, such as a rigid shaft, can be used to extend the sharp
pin 1610 outwardly from the fin-type member 1609.
[0447] FIG. 24 is a top perspective view of an implantable shoulder
prosthesis comprising a plurality of glenoid fixation members each
having an access port through which material such as an adhesive
material can be added in accordance with embodiments of the present
invention. A shoulder prosthesis 100 can comprise a glenoid member
101 and a plurality of glenoid fixation members 106 each having an
access port or adhesive inlet through which an adhesive material
can be added. The access port or adhesive inlet of the glenoid
fixation members 106 can comprise a resealable septum 1706, which
can be connected inline with a chamber 1708 and a transport tube
1712.
[0448] After implantation of the shoulder prosthesis 100, a cavity
1716 can form in the glenoid region of a scapula 110 as a result of
various types of load forces exerted on glenoid member 101. As a
result of one or more cavities 1716, notching and chipping of
scapula bone and/or loosening of the glenoid member 101 may occur.
To prevent further damage to or loosening of the shoulder
prosthesis 100 and surrounding glenoid area of the scapula 110, a
fill material 1702 can be injected , via a syringe 1700 into the
cavity 1716 formed in the scapula 110. Fill material 1702 may
comprise a cement such as orthopedic bone cement, a glue material,
an elastomeric material , a gel foam, a suture material, a nitinol
filament, and/or other biocompatible, injectable material. In one
embodiment, a needle 1704 of the syringe 1700 is used to pierce the
resealable septum 1706. Once pierced, the adhesive material 1702
can be injected into the chamber 1708, through a transport tube
1712 of the glenoid fixation member 106, and out of an output port
1714 into the cavity 1716. As a result, the notching and chipping
of scapula bone and/or loosening of the glenoid member 101 can be
prevented.
[0449] In one embodiment, the resealable septum 1706 is constructed
and arranged to be accessed percutaneously. In another embodiment,
the resealable septum 1706 is constructed and arranged to be
accessed in a minimally invasive procedure. In another embodiment,
the resealable septum 1706 is constructed and arranged to be
accessed in an open surgical procedure.
[0450] Glenoid fixation members 106 may comprise a rotatable anchor
107 configured to engage the scapula 110 when fixation member 106
is rotated; however, other types glenoid fixation members 106 may
be used to attach the glenoid member 101 to a scapula 110. For
example, a screw, pin, keel or other projection may include an
access port or adhesive inlet through which an adhesive or other
fill material can be injected.
[0451] FIGS. 25a, 25b and 25c are top perspective views of an
implantable shoulder prosthesis comprising a plurality of glenoid
fixation members in which subsets of the plurality of glenoid
fixation members are engaged during separate procedures in
accordance with embodiments of the present invention. A shoulder
prosthesis 100 can comprise a glenoid member 101 and a plurality of
glenoid fixation members 106. For example, the shoulder prosthesis
can comprise a first glenoid fixation member 106a, a second glenoid
fixation member 106b, and third glenoid fixation member 106c, and a
fourth glenoid fixation member 106d. In this embodiment, the
glenoid fixation members 106 (e.g., first-fourth glenoid fixation
members 106a/106b/106c/106d) comprise rotatable engagement anchors;
however, other glenoid types of glenoid fixation members 106 can be
used to attach the glenoid member 101 to a scapula 110.
[0452] In one embodiment, the rotatable engagement anchors can
comprise engageable (e.g. comprising a slot for rotation with a
screwdriver) securing portions 109 for attaching the glenoid member
101 to a glenoid cavity of a scapula 110. Further, the engageable
securing portions can be engaged in response to a magnetic
field.
[0453] Referring to FIG. 25a, the glenoid member 101 is shown
having a complete set of glenoid fixation members
106a/106b/106c/106d implanted in a scapula 110. In this embodiment,
the complete set glenoid fixation members 106a/106b/106c/106d are
shown un-engaged.
[0454] Referring to FIG. 25b, a first subset of glenoid fixation
members 106b and 106c are shown engaged, securing the glenoid
member 101 to a glenoid cavity of a scapula 110.
[0455] Referring to FIG. 25c, the remaining glenoid fixation
members 106a and 106d are shown engaged, further securing the
glenoid member 101 to a glenoid cavity of a scapula 110. The
complete set of engaged glenoid fixation members
106a/106b/106c/106d is shown.
[0456] In one embodiment, the first subset of glenoid fixation
members 106b and 106c or a portion thereof is engaged, securing the
glenoid member 101 to a glenoid cavity of a scapula 110 via
securing portion 109 in a first operation or procedure.
Subsequently, if the glenoid member 101 becomes loose subsequent to
the first operation or procedure, the remaining glenoid fixation
members 106a and 106d or a portion thereof, can be engaged via
securing portion 109, thus re-securing the glenoid member 101 to a
glenoid cavity of a scapula 110. For example, in a second operation
or procedure, at least 24 hours after the engagement of the first
subset of glenoid fixation members 106b and 106c or a portion
thereof, the remaining glenoid fixation members 106a and 106d or a
portion thereof is engaged.
[0457] In one embodiment, the remaining glenoid fixation members
106a and 106d or a portion thereof can be accessed and engaged
percutaneously. In another embodiment, the remaining glenoid
fixation members 106a and 106d or a portion thereof can be accessed
and engaged in a minimally invasive procedure. In another
embodiment, the remaining glenoid fixation members 106a and 106d or
a portion thereof can be accessed and engaged in an open surgical
procedure.
[0458] FIG. 26 is a block diagram of a pressure sensing system in
accordance with embodiments of the present invention. A pressure
sensing system 2001 can comprise signal processor 2000, such as, a
microprocessor, a digital signal processor, and the like, at least
one pressure sensor 2002, an optional biasing element (such as
biasing element 2004 of FIG. 28), a communication device 2006 and a
power supply 2008.
[0459] In some embodiments, the signal processor 2000 comprises
data storage elements, such as, non-volatile and volatile memory.
In addition, in other embodiments, the pressure sensing system 2001
can further comprises external data storage elements (not shown),
such as, non-volatile and volatile memory, which are connected to
the signal processor 2000.
[0460] The pressure sensor 2002, or a plurality thereof, are
electrically connected to the signal processor 2000. The signal
processor 2000 receives pressure information in the form of analog
or digital signals from the pressure sensor 2002, and as a result,
determines if the measured pressure is above, below or equal to a
predetermined threshold value stored in system memory.
[0461] The power supply 2008 is electrically connected to the
pressure sensing system 2001, and supplies electrical energy
thereto. In one embodiment, the power supply 2008 comprises one or
more rechargeable batteries of the following types or a combination
thereof: Lead-acid, Alkaline, Ni-iron, Ni-cadmium, NIH2, NIMH,
Ni-zinc, Li ion, Li polymer, Li sulfur[8], Li titanate, Thin film
Li, ZnBr, or Silver zinc. In other embodiments, the power supply
comprises one or more single-use type batteries.
[0462] The communication device 2006 is electrically connected to
the signal processor 2000. The communication device 2006 can be
used to program, initialized, reset, or adjust the pressure sensing
system 2001. In one operating mode, the communication device 2006
receives program data and initialization data from an external
device.
[0463] In another operating mode, the communication device 2006
transmits stored pressure information (e.g., data). For example,
the communication device can be configured to generate a pressure
sensor signal corresponding to a pressure measured between the
medial face 122 of the glenoid member 101 and a glenoid cavity of a
scapula 110. Sensing system 2001 may comprise wireless telemetry,
such as information transferred via electromagnetic waves such as
radiofrequency waves, light such as infrared light, or other
wireless means which transmit information to an external receiver,
such as a computer, cellular telephone or the like.
[0464] The communication device 2006 can comprise a wireless
communication device for transmitting the pressure information or
pressure sensor signal. The wireless communication device can
operate on a frequency band selected from the group consisting of:
30-300 kHz, 300-3000 kHz, 3-30 MHz, 30-300 MHz, 300-3000 MHz, 3-30
GHz and 30-300 GHz.
[0465] FIG. 28 is a top perspective view of an implantable shoulder
prosthesis comprising a pressure sensing system in accordance with
embodiments of the present invention. An implantable shoulder
prosthesis 100 can comprise a glenoid member 101 and pressure
sensing system 2001.
[0466] In one embodiment, the signal processor 2000, the
communication device 2006 and the power supply 2008 are
encapsulated within the glenoid member 101. In other embodiments,
the signal processor 2000, the communication device 2006 and the
power supply 2008 of the pressure sensing system 2001 are partially
formed in the glenoid member 101.
[0467] The pressure sensing system 2001 optionally comprises
biasing elements 2004a and 2004b that bias the pressure sensors
2002a and 2002b in an outward direction, away from the medial face
122 of the glenoid member 101. The biasing element 2004 can
comprise a spring, a rubber plug, a foam plug, a silicon plug, a
plastic plug or a combination thereof.
[0468] In the case of a deformed scapula 110, a bulker 2012 can be
secured to a deformed portion of a scapula 110 by a fill material,
such that an implantable prosthesis 100 can be securely attached to
the scapula, such as to prevent rocking.
[0469] In one embodiment, fill material 1702 is selected from the
group consisting of: glue or other adhesive material; cement such
as orthopedic bone cement, gel foam, fill material including one or
more bone grafts, elastomeric material; and combinations of
these.
[0470] The methods disclosed herein can be implemented by the
pressure sensing systems 2001 of FIGS. 26 and 28, or equivalent
systems, executing a unique set of instructions stored in system
memory. As will be appreciated by those skilled in the art, a
unique set of instructions can be implemented or embodied in
software, firmware, or a combination thereof.
[0471] FIG. 27 is a flow diagram illustrating a method of operating
a pressure sensing system in accordance with embodiments of the
present invention. A pressure sensing system, such as the pressure
sensor system 2001 of FIG. 26 or 28, is powered on and initialized
to execute a unique set of instructions. In one embodiment, the
unique set of instructions correspond to the method of operation
disclosed in FIG. 27.
[0472] The signal processor 2000 of the pressure sensing system
2001 receives pressure information in the form of analog or digital
signals from the pressure sensor 2002 (10). The signal processor
2002 converts/processes the received signal to digital form if
necessary (20), and determines if the measured pressure is above,
below or equal to a predetermined threshold value stored in system
memory (30). If the measured pressure is above the predetermined
threshold, the pressure sensing system continues to receive and
process pressure information from the pressure sensor 2002 (10/20).
If the measured pressure is equal to or below the predetermined
threshold, a modification signal is generated by the signal
processor 2000 indicating that the glenoid member 101 may be
loose.
[0473] Furthermore, the pressure sensing system 2001 may store the
received pressure information received from the pressure sensor
2002 for each iteration in system memory. This stored information,
can be later accessed via the communication device 2006.
[0474] FIG. 29 is a lateral/medial facing view of a scapula
illustrating pressure sensor locations in accordance with
embodiments of the present invention. The implantable shoulder
prosthesis 100 comprising the pressure sensing system 2001 as
illustrated in FIG. 26 can be constructed and arranged so that one
or more pressure sensors 2002 monitor the pressure at least one of
four glenoid cavity locations, which correspond to an upper glenoid
cavity location 2100, a right glenoid cavity location 2102, and
lower glenoid cavity location 2104 and a left glenoid cavity
location 2106.
[0475] FIG. 30 is a top perspective view of an implantable shoulder
prosthesis comprising a plurality of access ports through which an
adhesive material can be added in accordance with embodiments of
the present invention. A shoulder prosthesis 100 can comprise a
glenoid member 101 having at least one access port or adhesive
inlet disposed therein through which an adhesive material can be
added.
[0476] The access port or adhesive inlet of the glenoid member 101
can comprise a resealable septum 1706, which can be connected
inline with a chamber 1708 and an outlet port 1714.
[0477] After implantation of the glenoid member 101, a notch 2200a
and/or 2200b can form in the glenoid region of a scapula 110 as a
result of various types of load forces exerted on glenoid member
101. As a result of the notch 2200a and/or 2200b, loosening of the
glenoid member 101 may occur, such as due to rocking. To prevent
further damage to or loosening of the shoulder prosthesis 100 and
surrounding glenoid area of the scapula 110, an adhesive or other
fill material 1702, such as orthopedic bone cement or other fill
material described above, can be injected via a syringe 1700 into
notch 2200a and/or 2200b formed in the scapula 110.
[0478] In one embodiment, a needle 1704 of the syringe 1700 is used
to pierce the resealable septum 1706. Once pierced, the adhesive
material 1702 can be injected into the chamber 1708 and out of an
output port 1714 into the notch 2200a and/or 2200b. As a result,
loosening of the glenoid member 101 can be prevented.
[0479] One or more of the components described hereabove may be
bioabsorbable or comprise a bioabsorbable portion, as has been
described in reference to FIG. 20 hereabove. Bioabsorption of these
portions is typically chosen to be at least one week, at least one
month, at least three months, and at least six months. Single
components or multiple components may be bioabsorbable, such as
bioabsorbable portions which absorb at similar or dissimilar
rates.
[0480] While the preferred embodiments of the devices and methods
have been described in reference to the environment in which they
were developed, they are merely illustrative of the principles of
the inventions. Modification or combinations of the above-described
assemblies, other embodiments, configurations, and methods for
carrying out the invention, and variations of aspects of the
invention that are obvious to those of skill in the art are
intended to be within the scope of the claims.
* * * * *