U.S. patent application number 14/640667 was filed with the patent office on 2015-09-10 for delivery system for articular surface implant.
The applicant listed for this patent is Arthrosurface Incorporated. Invention is credited to Timothy Brightman, Steven W. Ek, George Sikora.
Application Number | 20150250472 14/640667 |
Document ID | / |
Family ID | 54016216 |
Filed Date | 2015-09-10 |
United States Patent
Application |
20150250472 |
Kind Code |
A1 |
Ek; Steven W. ; et
al. |
September 10, 2015 |
Delivery System for Articular Surface Implant
Abstract
A implant delivery system for securing an implant to an anchor.
The implant delivery system includes a driver including a shaft, a
biasing body having a first end region configured to engage said
driver and a second end region configured to engage a portion of an
implant, and a suture extending between the anchor and the shaft of
the driver. The driver may be rotated to reduce the length of the
suture between the driver and the anchor and generate a biasing
force urging the implant into engagement with the anchor. The
biasing force is substantially not transmitted to the bone.
Inventors: |
Ek; Steven W.; (Bolton,
MA) ; Sikora; George; (Bridgewater, MA) ;
Brightman; Timothy; (Franklin, MA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Arthrosurface Incorporated |
Franklin |
MA |
US |
|
|
Family ID: |
54016216 |
Appl. No.: |
14/640667 |
Filed: |
March 6, 2015 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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61949774 |
Mar 7, 2014 |
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61949789 |
Mar 7, 2014 |
|
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61949824 |
Mar 7, 2014 |
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61950762 |
Mar 10, 2014 |
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Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61F 2/4606 20130101;
A61F 2002/4628 20130101; A61F 2002/30331 20130101; A61F 2/4081
20130101; A61F 2002/30405 20130101; A61F 2002/305 20130101; A61F
2310/00011 20130101; A61B 2017/0409 20130101; A61B 2017/044
20130101; A61F 2002/30649 20130101; A61F 2/30756 20130101; A61F
2/40 20130101; A61B 17/0642 20130101; A61B 2017/0648 20130101; A61F
2/30 20130101; A61F 2002/3085 20130101; A61F 2002/30364 20130101;
A61F 2/4637 20130101; A61F 2002/4627 20130101; A61F 2002/30462
20130101; A61F 2/28 20130101; A61F 2/4618 20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A delivery system for securing an implant with an anchor, the
delivery system comprising: a driver including a shaft, said driver
configured to wind a portion of a suture, said suture configured to
extend around a contact portion of said anchor disposed within a
bone; and a biasing body having a first end region including a
driver cradle configured to generally retain a portion of said
shaft as said driver is rotated relative to said biasing body, and
a second end region configured to engage a portion of said implant;
wherein rotation of said driver applies a biasing force against
said implant and said anchor to secure said implant with said
anchor, and wherein said biasing force is substantially not
transmitted to said bone.
2. The delivery system of claim 1, further comprising said suture,
wherein said suture includes a first region configured to be
generally secured to said shaft and a second region configured to
be disposed about said contact portion of said anchor.
3. The delivery system of claim 2, wherein said second region of
said suture includes a first and a second portion defining a cradle
configured to engage said contact portion of said anchor.
4. The delivery system of claim 3, wherein said biasing body is
configured to maintain a separation angle of said first and second
portions of said cradle.
5. The delivery system of claim 1, wherein said driver cradle
includes an enlarged opening configured to allow said suture to
wind about said shaft as said shaft is rotated.
6. A system comprising: an implant system including: an anchor
configured to be secured in bone beneath a patient's articular
surface; and an implant configured to be secured to said anchor,
said implant replacing a portion of said patient's articular
surface; at least one suture having a first portion configured to
be disposed about a portion of said anchor; and an implant delivery
system comprising: a driver including a shaft; and a biasing body
having a first end region configured to engage said driver and a
second end region configured to engage a portion of an implant;
wherein said driver is configured to wind a second portion of said
suture while engaged against said first end region to reduce a
length of said suture between said driver and said anchor and
generate a biasing force urging said implant into engagement with
said anchor, and wherein said biasing force is substantially not
transmitted to said bone.
7. The system of claim 6, wherein said first end region includes a
driver cradle configured to generally retain a portion of said
shaft as said driver is rotated relative to said biasing body.
8. The system of claim 6, wherein the suture includes a cradle
configured to engage a contact portion of said anchor.
9. The system of claim 8, wherein said biasing body is configured
to maintain a separation angle of said cradle.
10. The system of claim 9, wherein the biasing body includes at
least one suture alignment guide configured to guide maintain said
separation angle of said cradle.
11. The system of claim 6, wherein the driver and said anchor
include engagement portions configured to transmit torque.
12. The system of claim 6, wherein the biasing body is
self-aligning with respect to said implant as said biasing force is
applied.
13. A method of installing an articular surface implant in an
excision site formed in a patient's bone, said method comprising:
securing an anchor in said patient's bone within said excision
site; and applying a biasing force against an implant to urge said
implant into engagement with said anchor, wherein said biasing
force is substantially not transmitted to said bone.
14. The method of claim 13, wherein the applying said biasing force
comprises: applying a downward force on the implant assembly and an
upward force on the fixation element.
15. The method of claim 14, wherein a suture is coupled around a
portion of said anchor and a portion of a driver, and wherein said
biasing force is transmitted by through suture.
16. The method of claim 15, wherein the applying a biasing force
comprises: rotating the driver to increase a tension of the suture
between the driver and the anchor.
17. The method of claim 16, further comprising a biasing body
disposed between said drive and said implant.
18. The method of claim 17, wherein the suture includes a cradle
configured to engage a contact portion of said anchor, and wherein
said biasing body is configured to guide maintain a separation
angle of said cradle.
19. The method of claim 18, wherein a first end region of the
biasing body includes a driver cradle configured to generally
retain a portion of a shaft of said driver as said driver is
rotated relative to said biasing body.
20. The method of claim 13, wherein a suture is coupled around a
portion of said anchor and a portion of a driver, and wherein
applying said biasing force includes reducing a length of said
suture between said driver and said anchor.
21. An implant system comprising: an implant body comprising: a
load bearing surface having a contour substantially corresponding
to a removed portion of a patient's articular surface; a bone
facing surface; and a first fixation element; and an anchor
configured to be secured in bone beneath said removed portion of
said patient's articular surface, said anchor comprising a second
fixation element; wherein said first and said second fixation
element are configured to form a snap-fit connection
therebetween.
22. The implant system of claim 21, wherein said anchor defines an
implant cavity configured to receive at least a portion of said
bone facing surface of said implant.
23. The implant system of claim 22, wherein at least a portion of a
periphery of said cavity includes said second fixation element and
wherein at least a portion of said bone facing surface includes
said first fixation element.
24. The implant system of claim 23, wherein said second fixation
element extends along the entire periphery of said cavity.
25. The implant system of claim 23, wherein said first fixation
element extends along a periphery of said implant body.
26. The implant system of claim 21, wherein said first and said
second fixation elements are configured to prevent rotation of said
implant body relative to said anchor.
27. The implant system of claim 21, wherein first and said second
fixation elements are selected from a protrusion and a groove.
28. The implant system of claim 21, wherein at least a portion of
said anchor includes a threaded region configured to secure said
anchor to said bone.
29. The implant system of claim 21, wherein at least a portion of
said anchor includes at least one external protrusion configured to
secure said anchor to said bone.
30. The implant system of claim 21, wherein at least a portion of
said anchor includes at least one external groove configured to
secure said anchor to said bone.
31. The implant system of claim 21, wherein anchor includes a
longitudinal passageway.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application claims the benefit of U.S. Provisional
Application Ser. No. 61/949,774, filed Mar. 7, 2014; U.S.
Provisional Application Ser. No. 61/949,789, filed Mar. 7, 2014;
U.S. Provisional Application Ser. No. 61/949,824, filed Mar. 7,
2014; and U.S. Provisional Application Ser. No. 61/950,762, filed
Mar. 10, 2014, the entire disclosures of which are fully
incorporated herein by reference.
FIELD
[0002] The present disclosure relates to delivery systems for bone
implants, and more particularly, to delivery systems for articular
surface implants.
BACKGROUND
[0003] Articular cartilage, found at the ends of articulating bone
in the body, is typically composed of hyaline cartilage, which has
many unique properties that allow it to function effectively as a
smooth and lubricious load-bearing surface. When injured, however,
hyaline cartilage cells are not typically replaced by new hyaline
cartilage cells. Healing is dependent upon the occurrence of
bleeding from the underlying bone and formation of scar or
reparative cartilage called fibrocartilage. While similar,
fibrocartilage does not possess the same unique aspects of native
hyaline cartilage and tends to be far less durable.
[0004] In some cases, it may be necessary or desirable to repair
the damaged articular cartilage using an implant. One method of
installing an implant involves applying a blunt force, e.g., a
hammer/mallet or the like, to the implant. Unfortunately, some of
the blunt force is transmitted from the implant into the
surrounding bone and/or tissue and can cause damage to the
bone/tissue. This is particularly problematic in small bones (such
as, but not limited to, bones in the hand and/or foot) as well as
patients who suffer from reduced bone mass and density that can
lead to fracture (such as, but not limited to, osteoporosis or the
like).
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] Features and advantages of the claimed subject matter will
be apparent from the following detailed description of some example
embodiments consistent therewith, which description should be
considered with reference to the accompanying drawings,
wherein:
[0006] FIG. 1 generally illustrates a cross-sectional view of one
embodiment of an implant system consistent with the present
disclosure secured within an excision site in a bone;
[0007] FIG. 2 generally illustrates a cross-sectional view of one
embodiment of an assembled implant system consistent with the
present disclosure;
[0008] FIG. 3 generally illustrates a cross-sectional view of one
embodiment of an unassembled implant system consistent with the
present disclosure;
[0009] FIG. 4A generally illustrates an exploded, cross-sectional
view of one embodiment of an implant delivery system consistent
with the present disclosure;
[0010] FIG. 4B generally illustrates a partial view of another
embodiment of an implant delivery system consistent with the
present disclosure;
[0011] FIG. 5 generally illustrates an assembled, cross-sectional
view of one embodiment of an implant delivery system consistent
with the present disclosure;
[0012] FIG. 6 generally illustrates an assembled, perspective view
of one embodiment of an implant delivery system consistent with the
present disclosure;
[0013] FIG. 7 generally illustrates a cross-sectional view of one
embodiment of an implant delivery system securing an anchor within
an excision site in a bone consistent with the present
disclosure;
[0014] FIG. 8 generally illustrates a cross-sectional view of an
anchor secured within an excision site in a bone consistent with
the present disclosure;
[0015] FIG. 9 generally illustrates a cross-sectional view of an
implant delivery system securing an implant to an anchor consistent
with the present disclosure;
[0016] FIG. 10 generally illustrates a perspective view of an
implant delivery system for securing an implant to an anchor
consistent with the present disclosure;
[0017] FIG. 11 generally illustrates another cross-sectional view
of an implant delivery system securing an implant to an anchor
consistent with the present disclosure; and
[0018] FIG. 12 generally illustrates another perspective view of an
implant delivery system for securing an implant to an anchor
consistent with the present disclosure.
[0019] Although the following Detailed Description will proceed
with reference being made to some illustrative example embodiments,
many alternatives, modifications, and variations thereof will be
apparent to those skilled in the art.
DETAILED DESCRIPTION
[0020] Generally, the present disclosure may feature systems,
devices and/or methods for installing an implant anchor and/or
delivering and attaching an implant to the anchor. By way of a
general overview, one embodiment of the present disclosure may
feature an implant delivery system for use with an implant system
having an anchor and an implant (e.g., implant body) configured to
be secured thereto. The implant delivery system may be used to
facilitate delivering (e.g., securing) the anchor to the bone
beneath a patient's articular surface and/or to couple, mount, or
otherwise secure the implant body to the anchor. For example, the
implant delivery system may be configured to generate sufficient
force to allow the implant body to be secured to the anchor without
applying any force to the surrounding bone or tissue. More
specifically, the implant delivery system may generate and apply a
biasing force against the implant and the anchor which urges the
implant body into engagement with the anchor, thereby securing the
implant body to the anchor without applying any force to the
surrounding bone. The biasing force generated by the implant
delivery system may therefore be applied only to the implant
system, and not the surrounding bone or tissue.
[0021] Because the biasing force is not transmitted/applied into
the surrounding bone or tissue, the implant delivery system may
reduce, minimize, and/or eliminate damage to the surrounding bone
while securing the implant body to the anchor, thereby allowing the
implant delivery system to be used with small bones (such as, but
not limited to, phalange bones and/or metatarsal bones in the foot
and/or hands) as well with patients who suffer from reduced bone
mass and density that can lead to fracture (such as, but not
limited to, osteoporosis or the like). Additionally, because the
implant delivery system is capable of generating high biasing
forces without transmitting/applying the biasing force to the
surrounding bone or tissue, the connection between the implant body
and the anchor may be stronger and more robust, thereby increasing
the life expectancy of the implant system.
[0022] Turning now to FIGS. 1-3, one embodiment of an implant
system 10 which may be used with an implant delivery system
consistent with the present disclosure is generally illustrated. In
particular, FIG. 1 generally illustrates the implant system 10
installed in the articular surface 12 of a patient's bone 14, FIG.
2 generally illustrates an assembled implant system 10, and FIG. 3
generally illustrates an exploded, unassembled implant system 10
consistent with the present disclosure. The implant system 10 may
generally include an implant (e.g., implant body) 16 configured to
be secured to an anchor 18. The anchor 18 is configured to be
secured to the bone 14 within an excision site 20 formed beneath
the patient's articular surface 12 such that a load bearing surface
22 of the implant 16 is generally flush with the patient's
surrounding articular surface 12 as generally illustrated in FIG.
1. The excision site 20 may be formed using any method and system
known to those skilled in the art, such as, but not limited to, as
the systems and methods as described in U.S. Pat. Nos. 6,520,964,
6,610,067, 6,679,917, 7,678,151, 7,896,883, 8,177,841, and
8,388,624, as well as U.S. Publication No. 2010/0368238, all of
which are fully incorporated herein by reference. According to one
embodiment, the anchor 18 may be secured to the bone 14, for
example, using one or more external threads, ribs, protrusions,
bone cement, barbs, grooves or any other structure 21 that enables
the anchor 18 to be secured to the bone 14. The use of threads 21
as generally illustrated may advantageously allow the height of the
implant 12 to be adjusted by rotating the anchor 18 within the bone
14 such that the implant 16 is flush with the surrounding articular
surface 12.
[0023] It should be appreciated that the implant system 10
illustrated is provided for illustrative purposes, and that the
implant delivery system may be used with any multi-piece implant
having an anchor that is coupled (either directly or indirectly) to
an implant/implant body. For example, the implant delivery system
may be used with implant systems for replacing any articular
surface such as, but not limited to, shoulder joints (e.g., but not
limited to, the glenohumeral joint), hip joint (e.g., but not
limited to, the acetabulofemoral joint), foot and/or hand joints
(e.g., but not limited to, metacarpophalangeal joints,
metatarsophalangeal joints, and/or interphalangeal joints), or the
like. The implant systems may include total joint implants (wherein
all or substantially all of the articular surface of at least one
bone is replaced with the artificial surface of the implant) and/or
partial implants (wherein substantially only the damaged portion(s)
of the articular surface of a bone is replaced with the artificial
surface of the implant). The implant delivery system may also be
used to secure together a multi-piece pin or rod in a bone to
facilitate healing of a fracture or broken bone.
[0024] As discussed above, the implant 16 may be secured to the
anchor 18 by way of a connection. For example, the implant 16 may
include at least one first fixation element 24 configured to engage
with at least one second fixation element 26 of the anchor 18 to
secure the implant 16 to the anchor 18. According to one
embodiment, the first and the second fixation elements 24, 26 may
include one or more recesses, groves, slots or the like configured
to corresponding to one or more protrusions, ribs, barbs, or the
like, for example, in a snap-fit arrangement in which the first
and/or second fixation elements resiliently deflect. The first and
second fixation elements 24, 26 may be disposed about the entire
perimeter/periphery of the implant 16 and anchor 18, and/or about
one or more regions of the perimeter/periphery. The first and
second fixation elements 24, 26 may prevent the implant 16 from
becoming free relative to the anchor 18 (for example, to prevent
axial and/or rotational movement of the implant 16 relative to the
anchor 18). Optionally, the implant 16 may be at least partially
received in an implant cavity 28 formed in the anchor 18 such that
a bone facing surface 30 of the implant 16 engages against at least
a portion of the implant cavity 28, thereby preventing the implant
16 from moving distally when a force is applied to the load bearing
surface 22.
[0025] It should be appreciated that while the first and second
fixation elements 24, 26 are generally illustrated as a recess and
a protrusion, respectively, the implant system 10 consistent with
the present disclosure is not limited to this arrangement unless
specifically claimed as such. For example, the first and second
fixation elements 24, 26 may include a protrusion and a recess,
respectively, as well as other embodiments. Additionally, the
anchor 18 may optionally include a passageway 32, for example, a
longitudinal passageway, configured to be advanced over a guide
wire (not shown) as generally described in U.S. Pat. Nos.
6,520,964, 6,610,067, 6,679,917, 7,678,151, 7,896,883, 8,177,841,
and 8,388,624, as well as U.S. Publication No. 2010/0368238, all of
which are fully incorporated herein by reference. For example, the
anchor 18 may be inserted into bone 14 or may be inserted into a
shaft drilled in the bone 14 to reduce risks or complications
arising from the insertion of the anchor 18. Without limitation, a
pilot hole may be formed in the bone 14 for receiving the anchor 18
prior to installing the anchor 18. A diameter of the pilot hole may
be smaller than the anchor 18, although example embodiments may
vary and are not limited thereto.
[0026] It may be appreciated that the strength or ruggedness of the
snap-fit connection between the implant 16 and the anchor 18 may
depend on the selected materials (e.g., the rigidity) and
size/dimensions. In general, more rigid (i.e., less deformable)
materials and/or larger sizes/dimensions will result in a stronger,
more robust connection between the implant 16 and the anchor 18.
While a stronger and more robust connection between the implant 16
and the anchor 18 is generally desirable, the resulting force
necessary to make the snap-fit connection increases.
[0027] Traditionally, the force necessary to secure the implant 16
to the anchor 18 has been generated using a blunt force, e.g., a
hammer/mallet or the like. More specifically, with the anchor 18
secured in the bone 14, the surgeon attempts to align the implant
16 relative to the anchor 18 and impacts the implant 16 with the
hammer/mallet to force the implant 16 into engagement with the
anchor 18. As may be appreciated, however, a substantial amount of
force is also applied to the surrounding bone 14, and if the force
applied to the bone 14 is too great, the bone 14 may be damaged.
Consequently, the strength of the connection between the implant 16
and the anchor 18 may be limited in many applications (e.g., but
not limited to, small bones in the hand and foot as well as implant
system 10 installed proximate to the perimeter of a bone) by the
strength of the surrounding bone 14. Additionally, it may be very
difficult for the surgeon to properly align the implant 16 with
respect to the anchor 18.
[0028] As discussed herein, the implant delivery system consistent
with one embodiment of the present disclosure solves this problem
by generating a biasing force to secure the implant 16 to the
anchor 18 wherein the biasing force is only applied against the
implant 16 and the anchor 18. The biasing force generated by the
implant delivery system may therefore be applied only to the
implant system 10, and not the surrounding bone or tissue 14. An
implant delivery system consistent with the present disclosure may
also be used to facilitate securing the anchor 18 into the bone 14.
Features and aspects of an implant delivery system consistent with
the present disclosure will generally be described.
[0029] Turning now to FIGS. 4-12, systems and methods for securing
an anchor 18 into the bone and securing the implant 16 to the
anchor 18 using an implant delivery system 100 consistent with the
present disclosure are generally illustrated. In a first mode (as
generally illustrated in FIGS. 4-8), the implant delivery system
100 may be used to secure the anchor 18 into an excision site
formed in the bone. In a second mode (FIGS. 9-12), the delivery
system 100 may be used to secure the implant 16 to the anchor 18 to
assemble the implant system 10 within the excision site. As may be
appreciated, the implant delivery system 100 may be used with any
implant system 10 described herein and is not limited to the
illustrated implant system 10 unless specifically claimed as
such.
[0030] With reference to FIGS. 4-8, one embodiment of system and
method for using the implant delivery system 100 to secure the
anchor 18 to bone within an excision site is generally illustrated.
The implant delivery system 100 may include a driver 110, a biasing
body 112, and at least one suture 114. As explained herein, the
implant delivery system 100 may be configured to retain the anchor
18 into engagement with the driver 110 and to secure the anchor 18
to bone 14 within an excision site 20 (as generally illustrated in
FIGS. 7 and 8). For example, the driver 110 may be received through
the biasing body 112, and the suture 114 may be disposed around a
portion of the anchor 18 to provide increased control and/or
maintain contact between the driver 110 and the anchor 18 while
securing the anchor 18 into the bone 14 within the excision site
20. The excision site 20 may be formed using any method and system
known to those skilled in the art.
[0031] The driver 110, FIG. 4A, includes a longitudinally disposed
shaft 116 having an engagement portion 118 disposed about a distal
end 120. The engagement portion 118 is configured to be coupled
with a corresponding engagement portion 122 of the anchor 18 and to
transmit torque as generally illustrated in FIGS. 5-7. For example,
the engagement portion 118 may be a male-shaped coupling unit (such
as, but not limited to, a splined or hex-shaped driver) configured
to couple with a female-shaped coupling unit 122 (such as, but not
limited to, a splined or hex-shaped recession formed in the anchor
18) in order to rotate or drive the anchor 18 into the bone.
However, the engagement portions 118, 122 may vary and are not
limited thereto. For example, the driver 110 may be configured to
accept interchangeable bits having a different engagement portion
118 configurations, thereby allowing the engagement portion 118 of
the driver 110 to be coupled to the engaging portion 122 of the
anchor 18 using several different bits as necessary. Alternatively
(or additionally), the engagement portion 118 may have a
female-shaped coupling unit and the anchor 18 may have a
male-shaped coupling unit. The shape of the engaging portions 118,
122 may be other than splined or hexagonal, and those in the art
will recognize that one of any number of shapes or configuration
for such components may be employed in a device or method
consistent with example embodiments. Optionally, the engagement
portion 118 may be magnetized or otherwise configured to maintain
contact or control over the anchor 18.
[0032] While the engaging portion 122 of the anchor 18 is shown
located on an inner wall of the narrow portion of the anchor 18,
example embodiments may vary and are not limited thereto. For
example, the engaging portion 122 of the anchor 18 may be located
on an inner wall of the wide portion of the anchor 18 and/or on an
outer wall of either the narrow portion or the wide portion of the
anchor 18. Optionally, an intermediate or adapting portion (not
shown) may be used to connect the driver 110 to the anchor 18.
[0033] The driver 110 may optionally include a handle 124. The
handle 124 may facilitate grasping of the driver 110 and may be
configured to cause a rotational force or a torque on the shaft
116, which may ultimately impart a rotational force or torque on
the anchor 18 to secure the anchor 18 into the bone. The handle 124
may be separate from the shaft 116 (either permanently or removably
coupled thereto), or may be a unitary, single piece with the shaft
116. While the handle 124 is illustrated as having a larger width
than the shaft 116, example embodiments may vary and are not
limited thereto. For example, the handle 124 may include a lever
arm or may be configured to couple to a lever arm that is used to
create the rotational force or torque.
[0034] The handle 124 and/or the shaft 116 may be cannulated to
define a longitudinal passageway 126. The longitudinal passageway
126 may include proximal and distal openings 128a, 128b configured
to be advanced over a guide wire (not shown for clarity), for
example, when securing the anchor 18 into the bone within the
excision site.
[0035] The biasing body 112 defines a shaft passageway 132
extending between a first and a second end region 130a, 130b having
a first and second opening 134a, 134b. The shaft passageway 132 is
configured to receive at least a portion of the shaft 116 of the
driver 110, for example, as generally illustrated in FIGS. 5 and 6.
The shaft 116 and the shaft passageway 132 may be configured such
that the distal end 120 of the shaft 116 extends beyond the second
end 134b of the shaft passageway 132 to allow the engagement
portion 118 of the driver 110 to engage the corresponding
engagement portion 122 of the anchor 18, for example, as generally
illustrated in FIGS. 5 and 6. Optionally, the biasing body 112 may
include a driver cradle 121, discussed in greater detail herein,
which may be used to secure the implant 16 (not shown) with the
anchor 18.
[0036] Additionally, the second end region 130b may include a
fixation element 25 (FIG. 4B) which substantially corresponds to
the first fixation element 24 of the implant 16. In this manner,
the fixation element 25 of the second end region 130b of the
biasing body 112 may be coupled to the second fixation element 26
of the anchor 18 to generally secure the anchor 18 to the biasing
body 112. The connection between the biasing body 112 and the
anchor 18 may facilitate placement of the anchor 18 within the
excision site by creating a generally secure connection
therebetween. It may be appreciated, however, that the connection
between the fixation element 25 of the second end region 130b and
the second fixation element 26 of the anchor 18 does not need to be
as strong as the connection between the first and second fixation
elements 24, 26 since it is only generally intended to help advance
the anchor 18 to and align the anchor 18 within the excision
site.
[0037] Alternatively (or in addition to), the biasing body 112,
FIG. 4A, may be configured to receive a suture 114 disposed around
(e.g., wrap around) a portion of the anchor 18. Tension may be
applied to the suture 114 to generally urge the anchor 18 into
contact with the driver 110 and/or the biasing body 112 to provide
more control over and/or maintain contact between the driver 110
and the anchor 18. The suture 114 may be configured to extend
through and/or around the biasing body 112 in any manner known to
those skilled in the art. For example, the suture 114 may extend
through the first opening 134a of the shaft passageway 132 of the
biasing body 112, out through one or more suture
apertures/openings/passageways 136a, 136b, through one or more
suture alignment guides 138a, 138b and around a contact portion 140
of the anchor 18. The suture passageways 136a, 136b may allow the
suture 114 to pass from the exterior of the biasing body 112 to the
interior of the shaft passageway 132. While the suture passageways
136a, 136b are illustrated in the middle of the biasing body 112,
example embodiments may vary and are not limited thereto. It should
also be appreciated that the suture 114 does not have to pass
through the shaft passageway 132, and instead the biasing body 112
may include one or more separate passageways (not shown) for the
suture 114.
[0038] The suture alignment guides 138a, 138b are configured to
retain the suture 114 about the distal end of the biasing body 112.
According to one embodiment, the suture 114 may include a first and
a second portion 142a, 142b (best seen in FIG. 6) which form a
basket, cradle, or frame 144 extending about the contact portion of
the anchor 18. The first and second portions 142a, 142b may be
formed from two or more pieces of suture, or may be formed from a
single piece of suture. The suture alignment guides 138a, 138b may
be configured to prevent the first and second portions 142a, 142b
of the cradle 144 from slipping off the anchor 18 by restricting
the separation angle S of the first and second portions 142a, 142b
of the cradle 144.
[0039] While the suture alignment guides 138a, 138b are shown at
the distal end of the biasing body 112 nearest the anchor 18,
example embodiments may vary and are not limited thereto. For
example, the suture alignment guides 138a, 138b may be located
anywhere along the biasing body 112 provided the suture alignment
guides 138a, 138b may prevent the suture 114 from slipping off the
anchor 18. Additionally, while the suture alignment guides 138a,
138b are shown as an exterior protrusion of the biasing body 112
with holes to allow the suture 114 to pass through, example
embodiments may vary and are not limited thereto. For example, the
suture alignment guides 138a, 138b may be flush with the biasing
body 112 or may protrude in an arc shape, with a gap between one
edge of the suture alignment guides 138a, 138b and the biasing body
112 to allow the suture 114 to enter. It may also be appreciated
that the length of the suture alignment guides 138a, 138b may vary
and the suture alignment guides 138a, 138b may be integrated into
the suture passageways 136a, 136b.
[0040] While the contact portion 140 of the anchor 18 is shown on
the bottom edge of the anchor 18, example embodiments may vary and
the contact portion 140 may be situated anywhere along the anchor
18. For example, the contact portion 140 may also be disposed about
the top portion of anchor 18. The contact portion 140 of the anchor
18 may include a flat edge or may include guides, grooves, slots,
or channels configured to receive the suture 114. For example, the
suture 114 may extend through a passageway formed in the anchor 18
such that a portion of the anchor 18 generally surrounds the suture
114, and the cradle 144 may be eliminated.
[0041] To secure the anchor 18 to the bone 14 within the excision
site 20, the suture 114 may be received through the biasing body
112 (e.g., through the first opening 134a of the shaft passageway
132, out through the suture passageways 136a, 136b, and through the
suture alignment guides 138a, 138b) such that the cradle 144 is
disposed about the contact portion 140 of the anchor 18 as
generally illustrated in FIG. 4A. The driver 110 may be advanced
through shaft passageway 132 until the engagement portion 118
contacts the corresponding engagement portion 122 of the anchor 18.
The suture 114 may then be tensioned to retain the engagement
between the driver 110 and the anchor 18, for example, by applying
a force against the suture 114 in a direction generally away from
the anchor 18 as generally illustrated in FIGS. 5 and 6.
Alternatively (or in addition), the fixation element 25 (FIG. 4B)
of the biasing body 112 may be secured to the fixation element 26
of the anchor 18, and the driver 110 may engage the anchor 18 as
described herein.
[0042] With the anchor 18 securely engaged with the driver 110, the
anchor 18 may be advanced to and aligned with the excision site 20
(as generally illustrated in FIG. 7) formed in the patient's
articular surface 12 and bone 14. Optionally, the anchor 18 may be
aligned with the excision site 20 using a guide wire 146 extending
outwardly from the bone 14 within the excision site 20. Because the
anchor 18 is retained against the driver 110, it is easier for the
surgeon to align the anchor 18 relative to the excision site 20. As
discussed herein, the anchor 18 may optionally include a cannulated
passageway 32 (best seen in FIG. 4A) that is generally aligned with
(e.g., generally co-axial) the longitudinal passageway 126 of the
driver 110 (as best illustrated in FIG. 7) such that the anchor 18
and the driver 110 (and optionally the biasing device 112) may be
advanced over the guide wire 146. The optionally use of the
cannulated passageway 32 and the guide wire 146 may further aid in
aligning the anchor 18 at the desired angle with respect to the
excision site 20 and the surrounding articular surface 12.
[0043] Once the anchor 18 is aligned with respect to the excision
site 20, the driver 110 may then be used to secure the anchor 18
into the bone 14, for example, by rotating the driver 110, thereby
causing the anchor 18 to rotate. The height of the anchor 18 may be
verified using a trial gauge (not shown) which may be easily
inserted/placed into the anchor 18 to ensure that the implant 16
(e.g., FIG. 1) is substantially flush with the surrounding
articular surface 21. Once the height of the anchor 18 is verified,
the driver 110 (and optionally the biasing device 112 and/or the
guide wire 146) may be removed, leaving the anchor 18 (and
optionally the suture 114) remaining in the bone 14, as generally
illustrated in FIG. 8. While the anchor 18 is illustrated having
threads 21, it may be appreciated that the anchor 18 may be secured
to the bone 14 using any device(s) known to those skill in the art
including, but not limited to, ribs, barbs, bone cement, porous
structures, and the like.
[0044] It should also be appreciated that the biasing device 112
does not have to be used when advancing and/or aligning the anchor
18 with respect the excision site 20. For example, the biasing
device 112 may be eliminated and tension may be applied to the
suture 114 to keep the anchor 18 engaged with the driver 110.
Alternatively, the anchor 18 may be advanced to and aligned with
the excision site 20 without using the driver 110. For example, the
suture 114 may be secured about a portion of the anchor 18, and
once the anchor 18 is aligned within the excision site 20, the
driver 110 may engage the anchor 18 and used to secure the anchor
18 within the excision site 20 in the bone 14.
[0045] Turning now to FIGS. 9-12, systems and methods for securing
an implant 16 to the anchor 18 using an implant delivery system 100
consistent with the present disclosure are generally illustrated.
As discussed herein, the implant delivery system 100 may be
configured to generate a biasing force to secure the implant 16 to
the anchor 18 wherein the biasing force is only applied against the
implant 16 and the anchor 18, and not the surrounding bone or
tissue 14.
[0046] With the anchor 18 secured to the bone 14 and the suture 114
disposed about the contact portion 140 of the anchor 18 as
described herein, the implant 16 may be arranged (i.e., placed)
between the anchor 18 and the second end region 130b of the biasing
device 112 as generally illustrated in FIGS. 9 and 10. The suture
114 may extend around the contact portion 140 of the anchor 18,
through suture alignment guides 138a, 138b and suture passageways
136a, 136b, and exit through the first opening 134a of the shaft
passageway 132 of the biasing body 112. The suture 114 may also be
generally coupled or secured to a portion of the driver 110, for
example, a portion of the shaft 116. For example, the driver 110
may include a suture engagement 148 configured to allow the suture
114 to be generally fixed or retained by the driver 110.
[0047] According to one embodiment, the suture engagement 148 may
include a hole or aperture through the shaft 116. At least a
portion of the suture 114 may pass through the hole 148, and the
suture 114 may be secured within the suture engagement 148 as the
driver 110 is rotated to reduce the length L of the suture 114
between the driver 110 and the anchor 18 as explained herein. It
should be appreciated that the suture engagement 148 may include
any device for generally securing the suture 114 to the driver 110.
For example, the suture engagement 148 may include an external
protrusion, a groove, non-cylindrical region, and/or a slot
configured to secure the suture 114. Alternatively, the suture 114
may be wrapped around the shaft 116, and the tension generated by
the rotation of the driver 110 may secure the suture 114 thereto.
The length of the biasing body 112 may be selected to allow the
surgeon sufficient room to rotate the driver 110, and therefore may
depend on the intended application.
[0048] With the suture 114 generally secured to the driver 110, the
driver 110 may be rotated about its longitudinal axis A as it is
received within the driver cradle 121. The driver cradle 121 may be
configured to receive the driver 110 (e.g., the shaft 116) and
generally retain the shaft 116 as the shaft 116 is rotated relative
to the biasing body 112. For example, the driver cradle 121 may
include one or ore recesses, grooves, or lips formed in the first
end region 134a of the biasing body 112. The driver cradle 121 may
also include one or more holes or passageways formed through the
biasing body 112 configured to receive and generally retain the
shaft 116.
[0049] Optionally, the driver cradle 121 may include an enlarged
opening 150 (best seen in FIG. 9). As the driver 110 is rotated,
the suture 114 begins to wrap around the shaft 116, thereby
increasing the diameter of the shaft 116. The enlarged opening 150
provides a void space that the suture 114 can pass through as the
driver 110 is rotated and the suture 114 builds up around the shaft
116. As a result, the suture 114 may generally avoid contact with
the driver cradle 121, and the torque necessary to rotate the
driver 110 may be reduced.
[0050] Turning now to FIGS. 11 and 12, with the implant 16 disposed
between the anchor 18 and the second end region 132b of the biasing
body 112, and the driver 110 (along with the suture 114 generally
secured thereto) disposed within the driver cradle 121, the surgeon
may rotate the driver 110 about longitudinal axis A to reduce the
length L of the suture 114 extending between the driver 110 and the
contact portion 120 of the anchor 118. The reduction in the length
L of the suture 114 generates a biasing force which urges the
implant 16 into engagement with the anchor 18. As may be
appreciated, the implant delivery system 100 generates a biasing
force which is applied against the implant 16 and anchor 18 through
the suture 114 only (i.e., substantially no force is applied to the
surrounding bone 14 or tissue).
[0051] More specifically, because the suture 114 supports the
anchor 18, rotation of the driver 110 about longitudinal axis A
increases the tension on the suture 114 (and therefore the biasing
force between the implant 16 and the anchor 18) in an opposite
direction of the downward force being placed upon the implant 16 by
the biasing body 112. Continued rotation of the driver 110
increases the biasing force between the implant 16 and the anchor
18 and, once the biasing force exceeds the required threshold to
install the implant 16, the implant 16 may be successfully
installed (e.g., secured) in the anchor 18. Thus, as a result of
the suture 114 applying a relatively equal and opposite force to
the anchor 18 and the biasing device 110 (and therefore the implant
16), the underlying bone 14 and other structures are not affected,
preventing or reducing potential injury from securing the implant
16 into the anchor 18. The implant delivery system 100 therefore
avoids and/or reduces any impact to the bone 14 (e.g., eliminates
blunt force due to a hammer/mallet or the like), and therefore
avoids and/or reduces damage to the bone 16.
[0052] Because the biasing force is not transmitted/applied into
the surrounding bone 14 or tissue, the implant delivery system 100
may be used with small bones (such as, but not limited to, phalange
bones and/or metatarsal bones in the foot and/or hands.
Additionally, because the implant delivery system 100 is capable of
generating high biasing forces without transmitting/applying the
biasing force to the surrounding bone 14 or tissue, the connection
between the implant body 16 and the anchor 18 (e.g., first and
second fixation elements 24, 26 as discussed herein) may be
stronger and more robust, thereby increasing the life expectancy of
the implant system 10. Moreover, the implant delivery system 100
may deliver the biasing force uniformly to the implant 16 and be
self-leveling or self-aligning, thereby reducing and/or eliminating
the difficulties associated with aligning the implant 16 with
respect to the anchor 18.
[0053] Once the implant 16 is secured to the anchor 18, the suture
114 may be removed from the implant system 10. For example, one or
more portions of the suture 114 may be cut and the resulting pieces
may be removed (e.g., pulled out) from the excision site 20.
Alternatively, a first end of the suture 114 may be released and
the suture 114 may be pulled through the biasing body 120 by a
second end of the suture 114, resulting in the first end traveling
through the shaft passageway 132c, through one of the suture
passageways 136a, 136b, out one of the alignment guides 138a, 138b,
around the anchor 18 and through the second of the alignment guides
138a, 138b and suture passageways 136a, 136b, and the shaft
passageway 132. However, example embodiments may vary and are not
limited thereto.
[0054] If the suture 114 is cut prior to removal, example
embodiments may vary and may include the suture 114 having various
shapes or loops. For example, the suture 114 may form a basket or
loop to wrap around the anchor 18. This shape may help support the
anchor 18 and may increase control over the anchor 18 prior to the
suture 114 being wrapped around the driver 110. In this
configuration, the loop may extend so that the loop can be severed
after installation of the implant system 10.
[0055] According to one aspect, the present disclosure may feature
a delivery system for securing an implant with an anchor. The
delivery system may include a driver including a shaft and a
biasing body. The driver may be configured to wind a portion of a
suture, wherein the suture is configured to extend around a contact
portion of the anchor disposed within a bone. The biasing body may
have a first end region and a second end region. The first end
region may include a driver cradle configured to generally retain a
portion of the shaft as the driver is rotated relative to the
biasing body. The second end region may be configured to engage a
portion of the implant. Rotation of the driver applies a biasing
force against the implant and the anchor to secure the implant with
the anchor, wherein the biasing force is substantially not
transmitted to the bone.
[0056] According to another aspect, the present disclosure may
feature a system comprising an implant system, at least one suture,
and an implant delivery system. The implant system includes an
anchor configured to be secured in bone beneath a patient's
articular surface, and an implant configured to be secured to the
anchor. The implant is configured to replace a portion of the
patient's articular surface. The suture has a first portion
configured to be disposed about a portion of the anchor. The
implant delivery system includes a driver including a shaft, and a
biasing body having a first end region configured to engage the
driver and a second end region configured to engage a portion of an
implant. The driver is configured to wind a second portion of the
suture while engaged against the first end region to reduce a
length of the suture between the driver and the anchor and generate
a biasing force urging the implant into engagement with the anchor,
wherein the biasing force is substantially not transmitted to the
bone.
[0057] According to yet another aspect, the present disclosure may
feature a method of installing an articular surface implant in an
excision site formed in a patient's bone. The method includes
securing an anchor in the patient's bone within the excision site,
and applying a biasing force against an implant to urge the implant
into engagement with the anchor, wherein the biasing force is
substantially not transmitted to the bone.
[0058] According to a further aspect, the present disclosure may
feature an implant system. The implant system may include an
implant body and an anchor. The implant body may include a load
bearing surface having a contour substantially corresponding to a
removed portion of a patient's articular surface, a bone facing
surface, and a first fixation element. The anchor may be configured
to be secured in bone beneath the removed portion of the patient's
articular surface, and may include a second fixation element. The
first and the second fixation element may be are configured to form
a snap-fit connection therebetween.
[0059] The terms and expressions which have been employed herein
are used as terms of description and not of limitation, and there
is no intention, in the use of such terms and expressions, of
excluding any equivalents of the features shown and described (or
portions thereof), and it is recognized that various modifications
are possible within the scope of the claims. Accordingly, the
claims are intended to cover all such equivalents. Various
features, aspects, and embodiments have been described herein. The
features, aspects, and embodiments are susceptible to combination
with one another as well as to variation and modification, as will
be understood by those having skill in the art. The present
disclosure should, therefore, be considered to encompass such
combinations, variations, and modifications.
[0060] All definitions, as defined and used herein, should be
understood to control over dictionary definitions, definitions in
documents incorporated by reference, and/or ordinary meanings of
the defined terms.
[0061] The indefinite articles "a" and "an," as used herein in the
specification and in the claims, unless clearly indicated to the
contrary, should be understood to mean "at least one."
[0062] The phrase "and/or," as used herein in the specification and
in the claims, should be understood to mean "either or both" of the
elements so conjoined, i.e., elements that are conjunctively
present in some cases and disjunctively present in other cases.
Other elements may optionally be present other than the elements
specifically identified by the "and/or" clause, whether related or
unrelated to those elements specifically identified, unless clearly
indicated to the contrary.
[0063] All references, patents and patent applications and
publications that are cited or referred to in this application are
incorporated in their entirety herein by reference.
* * * * *