U.S. patent application number 11/462728 was filed with the patent office on 2008-02-07 for medical device for repair of tissue and method for implantation and fixation.
This patent application is currently assigned to BioDuct, LLC. Invention is credited to Francis S. Proch, Herbert E. Schwartz.
Application Number | 20080033487 11/462728 |
Document ID | / |
Family ID | 39030227 |
Filed Date | 2008-02-07 |
United States Patent
Application |
20080033487 |
Kind Code |
A1 |
Schwartz; Herbert E. ; et
al. |
February 7, 2008 |
MEDICAL DEVICE FOR REPAIR OF TISSUE AND METHOD FOR IMPLANTATION AND
FIXATION
Abstract
The present invention relates to medical devices for repairing
tissue and more specifically to devices which facilitate tissue
regeneration and to surgical methods for the implantation and
fixation of such devices. In one embodiment, the medical device is
an elongate conduit that includes a longitudinal bore extending
therethrough to facilitate the transfer of blood from a vascular
region of tissue to a tear or damaged area located in an avascular
and/or semi-vascular region of tissue. A filament and/or filaments
are attached to the conduit and are positioned to secure the
conduit and fixate the adjacent tear walls in mutual engagement. In
another embodiment, a series of conduits are connected via a
filament and/or filaments to facilitate the implantation of
multiple conduits.
Inventors: |
Schwartz; Herbert E.; (Fort
Wayne, IN) ; Proch; Francis S.; (Huntertown,
IN) |
Correspondence
Address: |
BAKER & DANIELS LLP;111 E. WAYNE STREET
SUITE 800
FORT WAYNE
IN
46802
US
|
Assignee: |
BioDuct, LLC
Fort Wayne
IN
|
Family ID: |
39030227 |
Appl. No.: |
11/462728 |
Filed: |
August 7, 2006 |
Current U.S.
Class: |
606/232 |
Current CPC
Class: |
A61B 2017/044 20130101;
A61B 2017/0648 20130101; A61B 17/0401 20130101; A61B 17/064
20130101; A61B 17/0487 20130101; A61B 2017/0496 20130101; A61B
2017/0403 20130101; A61B 2017/0475 20130101; A61B 2017/0445
20130101; A61B 2017/0464 20130101; A61B 2017/0458 20130101; A61B
2017/0459 20130101; A61B 2017/0646 20130101; A61B 17/0469 20130101;
A61B 2017/0404 20130101 |
Class at
Publication: |
606/232 |
International
Class: |
A61B 17/04 20060101
A61B017/04 |
Claims
1. A medical device comprising: an elongate conduit formed of
biocompatible material, said device body having an exterior, a
first end, a second end, and a longitudinal bore; and a filament
attached to said device body, whereby said filament can be
positioned to fixate tissue in a desired position.
2. The medical device of claim 1 wherein said longitudinal bore of
said conduit extends from said first end to said second end.
3. The medical device of claim 1, wherein said conduit further
comprises an aperture.
4. The medical device of claim 3 wherein said filament is attached
to said conduit via said aperture.
5. The medical device of claim 3 wherein said apertures are in
communication with said longitudinal bore.
6. The medical device of claim 1 wherein said conduit further
comprises a surface feature extending from said exterior of said
body selected from the group consisting of ribs and threading.
7. The medical device of claim 1 wherein said conduit further
includes a slot.
8. The medical device of claim 1 wherein said conduit further
comprises a buckle.
9. A method for implanting a medical device in tissue, the tissue
having a first area of vascularity and a second area of
vascularity, the vascularity of the second area being less than the
vascularity of the first area, the method comprising the steps of:
inserting a device into tissue, said device including a conduit and
a filament attached to said conduit, said conduit having a first
end, a second end, and a bore therethrough; positioning said first
end of said conduit adjacent the outside wall of a torn or damaged
area of tissue; positioning said filament through said tissue to
secure said conduit and fixate the tissue in a desired position;
and securing said filament.
10. The method of claim 9 wherein the first said positioning step
further comprises locating said first end in a second area of
vascularity.
11. The method of claim 10 wherein the first said positioning step
further comprises positioning said second end of said device body
in a first area of vascularity.
12. The method of claim 9 wherein said securing step further
comprises looping said filament over said outside wall of a torn or
damaged area of tissue.
13. A method for implanting a medical device in tissue, the method
comprising the steps of: inserting a device into tissue, said
device including a plurality of conduits and a filament attached to
said conduits, said conduits having a first end, a second end, and
a bore therethrough; positioning said first end of each said
conduits adjacent the outside wall of a torn or damaged area of
tissue; positioning said filament through said tissue to secure
said conduit and fixate said tissue in a desired position; and
securing said filament.
14. The method of claim 13 wherein said tissue has a first area of
vascularity and a second area of vascularity, said first area
having greater vascularity than said second area, the first said
positioning step further comprising positioning said first end in
said second area of vascularity.
15. The method of claim 14 wherein the first said positioning step
further comprises positioning said second end of said conduit in
said second area of vascularity.
Description
BACKGROUND OF THE INVENTION
[0001] 1. Field of the Invention
[0002] The present invention relates to medical devices for
repairing tissue and more specifically to devices which facilitate
tissue regeneration and to surgical methods for the implantation
and fixation thereof.
[0003] 2. Description of the Related Art
[0004] Various parts of the human body are comprised of
fibrocartilage. Fibrocartilage forms the disc, meniscus, and
labrums, located in the spine and temporo-mandibular joint, knee,
and shoulder and hip, respectively. Additionally, fibrocartilage is
present in other parts of the human body, such as fingers, wrists,
and ankles. Fibrocartilage is a resilient, compressive tissue
capable of accepting and withstanding high loads imparted during
bodily movement. Generally, fibrocartilage is found between two
adjacent bones, such as the locations set forth hereinabove.
[0005] The fibrocartilage of the knee forms menisci 10, 11, shown
in FIG. 1. Menisci 10, 11 are semi-lunar, wedge-shaped portions of
tissue that sit atop the tibia and articulate with the tibia and
femur during movement of the tibia and/or femur relative to one
another. Menisci 10, 11 have top articulating surfaces 12 which
interface with the femoral condyle and bottom articulating surfaces
(not shown) which interface with tibia plateau 14. Menisci 10, 11
function as shock absorbers between the femur and the tibia to
distribute compressive and shear loads from the curved condyles of
the femur to the relatively flat plateau of the tibia. While much
of menisci 10, 11 can be classified as avascular and aneural, each
menisci 10, 11 has three distinct zones of vascularity, shown in
FIG. 2, a red zone 16, a red/white zone 18, and a white zone 20.
Red zone 16, comprised of approximately the outer peripheral third
of each meniscus, is rich in blood supply and is highly vascular.
White zone 20, comprised of approximately the inner peripheral
third of each meniscus, is completely void of blood supply and is
avascular. Red/white zone 18, comprised of the area between the red
zone and white zone, has some limited vascularity with limited
blood supply. As a patient ages, the size of the white zone 20 will
increase and the size of red zone 16 and red/white zone 18 will
correspondingly decrease.
[0006] Due to the high stress imparted on fibrocartilage, injuries
and pathologies can occur in the fibrocartilage which are
manifested in the form of tears, such as tear 22 shown in FIG. 3,
defects, and/or degeneration. Tears may occur due to the existence
of prior defects in the fibrocartilage, shear loading of the
fibrocartilage, and/or compounded loading resulting from repetitive
compressive loading occurring over a period of time. Additionally,
fibrocartilage can deteriorate as a result of aging, resulting in
hard and/or soft areas which further facilitate the creation of
tears therein.
[0007] One common procedure for treating fibrocartilage tears is to
surgically remove part or all of the fibrocartilage surrounding the
tear, such as removing a portion of the meniscus. These procedures,
known as meniscectomies or partial meniscectomies when performed on
the meniscus, are commonly utilized in the case of "unrepairable"
or complex tears such as radial tears, horizontal tears, and
vertical longitudinal tears occurring outside the vascular zone.
Additionally, these procedures may be performed when there is
fibrillation and/or degeneration caused by defects in an avascular
or limited vascular area, since these injuries are unlikely to
heal. As shown in FIG. 4, a partial meniscectomy may be performed
in which the meniscus is removed along lines extending inwardly
toward the inner meniscus from the peripheral ends of tear 22. In
some cases, implants may be inserted to replace the portion of the
meniscus removed during the procedure. Meniscectomies, and similar
fibrocartilage procedures, typically provide immediate pain relief
and restoration of knee function to a patient. However, cartilage
wear on the condylar or tibial plateau surfaces and the eventual
development of osteoarthritis may occur as a result of the
meniscectomy. Additionally, the onset of osteoarthritis may lead to
more chronic conditions resulting in the need for a total knee
replacement procedure.
[0008] Another method for treating fibrocartilage tears, including
tears of the meniscus, is to attempt to surgically repair the torn
tissue. This technique is most commonly performed when the tear is
a longitudinal vertical tear located in the vascular area of the
fibrocartilage, such as red zone 16 of meniscus 10, shown in FIG.
2. To facilitate tissue regeneration, the tear walls may be rasped
or trephined to induce bleeding. Additionally, the tear walls may
be stabilized with sutures or other retention devices.
[0009] A further method for treating fibrocartilage tears is the
subject of U.S. patent application Ser. No. 10/558,926 to Schwartz
("Schwartz '926"). The stent of Schwartz '926 is designed with an
interior, longitudinally-extending bore and external threads or
ribs. Stent 24, shown in FIG. 6, is inserted through fibrocartilage
tissue and positioned to extend across walls 26, 28 of
fibrocartilage tear 22, shown in FIG. 5, to secure the sides of the
tear together. The threads or ribbing of stent 24, denoted by
slanted, dashed lines in FIG. 6, effectively retain the stent, and
corresponding tear walls 26, 28, in position. Additionally, the
outer wall of stent 24 includes a plurality of apertures, not
shown, extending from the interior of the longitudinal bore to the
exterior surface of stent 24. These apertures allow for the
dissemination of blood, biological factors, and cells from stent
24, as blood, biological factors, and cells flow through stent 24
from a vascular region of the fibrocartilage to a semi-vascular or
avascular tear region of the fibrocartilage. The dissemination of
blood, biological factors, and cells via stent 24 stimulates tissue
regeneration. While the device disclosed in Schwartz '926 is
effective, the walls of the fibrocartilage tear may actually be
pushed apart during implantation of the stent and prevent effective
healing of the tear. Additionally, even when the sides of the tear
are properly aligned, the tear walls may loosen or migrate over
time. Further, the blood dissemination apertures in the stent may
not be as effective in providing maximum blood flow to the area of
interest as desired to effect healing.
[0010] What is needed is a device that is an improvement over the
prior art.
SUMMARY OF THE INVENTION
[0011] The present invention relates to medical devices for
repairing tissue and more specifically to devices which facilitate
tissue regeneration and to surgical methods for the implantation
and fixation of such devices. In one embodiment, the medical device
is an elongate conduit that includes a longitudinal bore extending
therethrough to facilitate the transfer of blood, biological
factors, and cells from a vascular region of tissue to a tear or
damaged area located in an avascular and/or semi-vascular region of
tissue. A filament and/or filaments are attached to the conduit and
are positioned to fixate the adjacent tear walls in mutual
engagement. In another embodiment, a series of conduits are
connected via a filament and/or filaments to facilitate the
implantation of multiple conduits while fixating the adjacent tear
walls.
[0012] Advantageously, the present medical device allows for the
provision of blood, biological factors, and cells from a vascular
region of tissue to a torn or damaged area located in an avascular
and/or semi-vascular region of tissue and provides for fixation of
the tear walls or damaged area and the securement of a conduit in a
desired position. Additionally, because the conduit itself anchors
one side of the primary tear fixation, the conduit can be located
with one end adjacent the plane of a tear, damaged area, or
implant, allowing the conduit to efficiently deliver blood,
biological factors, and cells thereto and increase the rapidity of
the healing process. Moreover, in addition to facilitating the
transfer of blood, biological factors, and cells from a vascular
region to an avascular and/or semi-vascular region, the conduit can
also provide for delivery of biological treatments, drugs, and
other substances, such as blood, platelet rich plasma, growth
factors, or cells, to the tear or defect area through the bore of
the conduit. The desired substance can be delivered before, during,
or after the conduit is inserted and positioned.
[0013] In one form thereof, the present invention provides a
medical device including an elongate conduit formed of
biocompatible material, the device body having an exterior, a first
end, a second end, and a longitudinal bore; and a filament attached
to the device body, whereby the filament can be positioned to
fixate tissue in a desired position.
[0014] In another form thereof, the present invention provides a
method for implanting a medical device in tissue, the tissue having
a first area of vascularity and a second area of vascularity, the
vascularity of the second area being less than the vascularity of
the first area, the method including the steps of: inserting a
device into tissue, the device including a conduit and a filament
attached to the conduit, the conduit having a first end, a second
end, and a bore therethrough; positioning the first end of the
conduit adjacent the outside wall of a torn or damaged area of
tissue; positioning the filament through the tissue to secure the
conduit and fixate the tissue in a desired position; and securing
the filament.
[0015] In another form thereof, the present invention provides a
method for implanting a medical device in tissue, the method
including the steps of: inserting a device into tissue, the device
including a plurality of conduits and a filament attached to the
conduits, the conduits having a first end, a second end, and a bore
therethrough; positioning the first end of each of the conduits
adjacent the outside wall of a torn or damaged area of tissue;
positioning the filament through the tissue to secure the conduit
and fixate the tissue in a desired position; and securing the
filament.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The above-mentioned and other features and advantages of
this invention, and the manner of attaining them, will become more
apparent and the invention itself will be better understood by
reference to the following descriptions of embodiments of the
invention taken in conjunction with the accompanying drawings,
wherein:
[0017] FIG. 1 is a perspective view of the menisci and other knee
anatomy;
[0018] FIG. 2 is a partial cross-sectional view along line 2-2 of
FIG. 1;
[0019] FIG. 3 is a perspective view of the menisci, including a
tear in the lateral meniscus and other knee anatomy;
[0020] FIG. 4 is a perspective view of the menisci and other knee
anatomy following a partial meniscectomy of the lateral
meniscus;
[0021] FIG. 5 is a partial cross-sectional view along line 5-5 of
FIG. 3;
[0022] FIG. 6 is a partial cross-sectional view of the lateral
meniscus of FIG. 3 including a prior art stent;
[0023] FIG. 7 is a plan view of an embodiment of the conduit of the
present invention;
[0024] FIG. 7A is a plan view of a conduit according to another
embodiment;
[0025] FIG. 7B is a cross-sectional view along line 7B-7B of FIG.
7A;
[0026] FIG. 7C is a plan view of a conduit according to another
embodiment;
[0027] FIG. 8 is a plan view of a conduit according to another
embodiment;
[0028] FIG. 9 is a plan view of a conduit according to another
embodiment;
[0029] FIG. 10 is a perspective view of an embodiment of the
present invention incorporating a conduit according to another
embodiment;
[0030] FIG. 11 is a perspective view of the device of FIG. 10
implanted in a meniscus;
[0031] FIG. 12 is a cross-sectional view along line 12-12 of FIG.
11;
[0032] FIG. 13 is a perspective view of a device according to
another embodiment;
[0033] FIG. 14 is a perspective view of the device of FIG. 13
implanted in a meniscus;
[0034] FIG. 15 is a perspective view of a device according to
another embodiment;
[0035] FIG. 16 is a elevational view along line 16-16 of the device
of FIG. 15
[0036] FIG. 17 is a perspective view of the device of FIG. 10
implanted in a meniscus and secured according to another
embodiment;
[0037] FIG. 18 is a perspective view of the device of FIG. 10
implanted in a meniscus according to another embodiment;
[0038] FIG. 19 is a perspective view of the device of FIG. 10
implanted in a meniscus and secured according to another
embodiment;
[0039] FIG. 19A is a perspective view of the device of FIG. 10
implanted in a meniscus and secured according to another
embodiment;
[0040] FIG. 20 is a perspective view of the device of FIG. 10
implanted in a meniscus and secured according to another
embodiment;
[0041] FIG. 21 is a perspective view of the device of FIG. 10
implanted in a meniscus including a scaffold replacement; and
[0042] FIG. 22 is a perspective view of a device according to
another embodiment.
[0043] Corresponding reference characters indicate corresponding
parts throughout the several views. The exemplifications set out
herein illustrate preferred embodiments of the invention and such
exemplifications are not to be construed as limiting the scope of
the invention any manner.
DETAILED DESCRIPTION
[0044] FIG. 7 shows conduit 30 according to one embodiment of the
present invention. Conduit, as used herein, means only an elongate
body and does not define any other structural features. Conduit 30
includes a first end 32, a second end 34, and through bore 36
extending from first end 32 to second end 34. In one embodiment,
bore 36 has a non-circular cross-section. Body 30 can be
manufactured from any biocompatible material. Body 30 has a length
from first end 32 to second end 34 as small as 2 mm, 3 mm, or 4 mm
and as large as 10 mm, 12 mm, or 15 mm. Additionally, conduit 30
may be coated with biocompatible substances to facilitate tissue
regeneration, improve circulation, or achieve any other
biologically desirable responses. For example, interior 38 of
through bore 36 may be coated with an anti-coagulant to prevent
coagulation of blood within through bore 36, thereby promoting the
delivery of blood to a torn or damaged tissue area. Alternatively,
bore 36 may contain a scaffold material to promote tissue
regeneration or to improve healing outcomes.
[0045] Conduit 30 may also be made of any porous material which
would allow for the transfer of blood from a vascular to an
avascular area as a result of physiological processes in the
patient's body. Moreover, such a porous construct may be two-piece,
shown in FIG. 7A and 7B, wherein end 32' of conduit 30' is closed
and constructed of a porous material, while the remainder of
conduit 30' is made of a substantially solid, biocompatible
material. This allows for blood or other fluid to enter 34 via bore
36 and exit through the porous material at end 32'. Alternatively,
conduit 30 may be constructed entirely of porous material and lack
bore 36, as shown in FIG. 7C. Fluid would enter conduit 30 from end
34 and travel, due to the interconnected porosity of the porous
material, through conduit 36, exiting at end 32. The flow of fluid
may be directed by altering the material properties of the porous
material along the length of conduit 30.
[0046] As shown in FIG. 7, conduit 30 further includes a plurality
of apertures 42, 44 at end 32 of body 30. Apertures 42, 44 extend
from interior 38 of through bore 36 to exterior surface 46.
Apertures 42, 44 may receive filament 48, as shown in FIG. 10 and
described in detail hereinbelow, for securing conduit 30 within
tissue and fixating a tear, damaged tissue, or an implant in a
desired position. As used herein, filament is inclusive of single
or multiple strands, threads, fibers, strings, wires or sutures. In
another exemplary embodiment, apertures 42, 44 are positioned
adjacent one another on the same side of conduit 30, i.e., along
the axial length of conduit 30, and receive filament 48 in the same
manner described in detail herein below. Location of apertures 42,
44 on the same side of conduit 30 provides for eccentric loading of
conduit 30 when filament 48 is fully secured, which impedes pull
out of conduit 30. Additionally, conduit 30 may include slot 47,
shown in FIG. 7, in end 32 of conduit 30 which allow for the exit
of blood or other substances therethrough. Slot 47 aid the surgeon
in positioning conduit 30 within tissue by eliminating the need for
the surgeon to precisely align end 32 of body 30 with the plane of
a tear, damaged area, or implant to provide blood thereto. As long
as the surgeon positions a portion of slot 47 in or adjacent the
plane of the tear, damaged area, or implant, blood or other
substances will be delivered to the tear, damaged area, or implant.
In effect, slot 47 provides an increased length, only a portion of
which the surgeon must locate adjacent the tear, damaged tissue, or
implant, thereby increasing the likelihood of a successful
implantation.
[0047] In an exemplary embodiment, end 32 is perforated with a
plurality of apertures of sufficient size and spacing to provide a
substantially similar benefit as slot 47, described above. In
another exemplary embodiment, shown in FIGS. 7A-7B, conduit 30'
includes closed end 32' perforated by a plurality of apertures 49
of sufficient size to allow for the dissemination of blood
therethrough. In another embodiment, the entire length of conduit
30 is perforated by a plurality of apertures 49 of sufficient size
to allow for the dissemination of blood therethrough. Additionally,
in another exemplary embodiment, the entire length of conduit 30 is
porous, allow the release of fluid along the entire length of
conduit 30.
[0048] FIGS. 8-10 show conduits 50, 60, 70, respectively, according
to additional embodiments of the present invention. Conduits 50,
60, 70 include several features which are identical to the
embodiment of FIG. 7 discussed above and identical reference
numerals have been used to indicate identical or substantially
identical features therebetween. Conduits 50, 60, shown in FIGS. 8
and 9, respectively, include surface features, such as outwardly
extending ribs 52 and outwardly extending thread 62, respectively,
on external surface 46 of conduits 50, 60. Ribs 52 and threads 62
provide an additional mechanism for fixation of conduits 50, 60
within tissue. As shown in FIG. 10, conduit 70 further includes
nose 72. Nose 72 is separated from main body portion 74 via
tapering section 76. During implantation, nose 72 facilitates
insertion of conduit 70 into the tissue and can be positioned such
that nose 72 is in a vascular tissue, such as the synovium, while
ribs 52 and/or threads 62 provide fixation. Additionally, nose 72
may itself be tapered to further ease insertion.
[0049] As shown in FIG. 10, conduit 70 includes filament 48
attached thereto, forming completed medical device 78. The devices
of the present invention are an improvement over the stent
disclosed in U.S. patent application Ser. No. 10/558,926 to
Schwartz, which is assigned to the assignee of the present
invention, the entire disclose of which is incorporated by
reference herein. Filament 48 may be manufactured from any
flexible, biocompatible material, such as polyglactin,
polydioaxanone, surgical gut, nylon, polypropeylyene, polyglycolic
acid, polylactic acid, co-polymers, Vicryl.RTM., and Ethibond
Excel.RTM.. Vicryl.RTM. and Ethibond Excel.RTM. are registered
trademarks of Johnson & Johnson Corporation, One Johnson &
Johnson Plaza, New Brunswick, N.J. 08933. Filament 48 and conduit
70 may be preassembled or may be assembled by the surgeon before or
during surgery. Filament 48 and conduit 70 may be connected
together by inserting a first end (not shown) of filament 48 into
interior 38 of through bore 36. The first end of filament 48 is
then threaded through aperture 42 and wrapped half-way around
exterior surface 46 until the first end reaches aperture 44. In
another embodiment, filament 48 is wrapped substantially entirely
around exterior surface 46. The first end of filament 48 is then
inserted through aperture 44 into interior 38 of through bore 36.
First end of filament 48 is then pulled out of through bore 36
through end 32. In another embodiment, exterior surface 46 includes
a groove (not shown) on at least a portion of exterior surface 46
transverse to the longitudinal axis of body 70. As filament 48 is
pulled from end 32 of body 70, filament 48 tightens, seating
filament 48 within the groove. Once device 78 is assembled, device
78 may be inserted into the meniscus as described in detail
hereinbelow.
[0050] In another embodiment, the first end of filament 48 is
inserted through aperture 42 into interior 38 of through bore 36
and pulled out of through bore 36 through aperture 44. In this
embodiment, a portion of filament 48 extends through interior 38 of
through bore 36 in a direction transverse to the longitudinal axis
of body 70. In another embodiment, device 80, as shown in FIGS.
15-16, includes conduit 82 having nose 72, through bore 36, and
overmolded end 84. Device 80 include several features which are
identical to the embodiment of FIG. 10 discussed above and
identical reference numerals have been used to indicate identical
or substantially identical features therebetween. As best seen in
FIG. 16, overmolded end 84 includes apertures 86, 88 extending from
rim 90 of end 32 toward opposing end 34 along a portion of conduit
82. Bores 86, 88 may be formed to be slightly larger than filaments
92, 94 and, during manufacturing, shrink around the ends of
filaments 92, 94 to retain the ends therein. Utilizing overmolded
end 84 prevents filaments 92, 94 from extending into through bore
36 and provides an uninterrupted path for the flow of blood and
other substances therethrough. In another embodiment, a
biocompatible adhesive is used to secure the ends of filaments 92,
94 within bores 86, 88. Once device 80 is assembled, device 80 may
be inserted into the meniscus as described in detail
hereinbelow.
[0051] The method for inserting the devices will now be described
in detail with reference to medical device 78, shown in FIG. 10.
Device 78 may be inserted into meniscus 10 as shown in FIGS. 11 and
12. In one embodiment, the entire procedure is performed
arthroscopically using standard techniques, procedures, and
devices. Device 78 is inserted from the interior side of tear 98 at
insertion point 100, located between inner rim 102 of meniscus 10
and the interior side of tear 98. In another exemplary embodiment,
the insertion point is the face of tear 98. Device 78 is inserted
along a plane substantially parallel to bottom articulation surface
14 of meniscus 10. While device 78 may be inserted at any angle
relative to bottom articulation surface 14, insertion along a plane
substantially parallel to bottom articulation surface 14 provides
the optimal purchase for conduit 70. In one embodiment, insertion
of device 78 is performed using a compatible insertion tool, such
as those disclosed in U.S. patent application Ser. No. 10/558,926
to Schwartz. The insertion tool (not shown) may be inserted into
the interior of through bore 36 to retain device 78 thereon and
advance device 78 through meniscus 10. In one embodiment, the
insertion device is cannulated. The use of a cannulated insertion
tool allows for the delivery of biological substances through the
insertion device and conduit 70 directly to the torn or damaged
area of meniscus 10. In another exemplary embodiment, device 78 is
inserted utilizing any technique known technique, including an
all-inside technique, inside-out technique, and/or an outside-in
technique.
[0052] Device 78 is advanced via the insertion tool until end 32 of
conduit 70 is substantially aligned with the plane of tear 98,
damaged area, or regenerative or replacement meniscus implant 134.
Additionally, when inserted to align with a damaged area of tissue,
the deterioration of the damaged tissue may provide tactile
feedback to the surgeon that the outer plane of the damaged area
has been encountered. As shown in FIG. 18, conduit 70 may be
positioned adjacent a tear, damaged area, or regenerative or
replacement meniscus implant 134 with nose 72 extending from outer
wall 106 of meniscus 10. In this position, nose 72 extends into the
synovium and/or other tissue surrounding the knee joint, which is a
highly vascular membrane surrounding the knee. In the same manner
as set forth above with reference to red zone 16 of meniscus 10,
blood, biological factors, cells, and fluid from the synovium
and/or other tissue surrounding the knee joint can be delivered to
a torn or damaged area of meniscus 10 via conduit 70.
[0053] Once positioned, the insertion tool is removed, leaving
conduit 70 in position and filament 48 extending from insertion
point 100. Ends (not shown) of filament 48 are then looped over
tear 98 and inserted in meniscus 10 at second insertion points 103,
104, shown in FIG. 11, located between outer wall 106 of meniscus
10 and tear 98 or between inner rim 102 of meniscus 10 and tear 98,
using, for example, a needle. The ends of filament 48 are advanced
through meniscus 10 at diverging angles until the ends exit outer
wall 106 at points 108, 110. The ends of filament 48 are then
tightened by pulling the ends away from outer wall 106. In addition
to the stitching method set out above, filament 48 can be
positioned via any method known to one of ordinary skill in the
art, including any horizontal or vertical mattress suture
technique.
[0054] With filament 48 taut, fixating inner and outer walls of
tear 98 in mutual engagement, the ends of filament 48 are secured
to one another. Once secured, device 78 is secured and the walls of
tear 98 are fixed in their relative positions. In one exemplary
embodiment, the ends of filament 48 are secured by tying the ends
together to form knot 112, shown in FIG. 11. Excess portions of
filament 48 may then be trimmed and discarded.
[0055] As shown in FIG. 17, in another exemplary embodiment, first
end 114 of filament 48 is secured to a retention device, such as
buckle 116, by inserting first end 114 through an aperture in end
118 of buckle 116 and tying end 114 to form knot 120. Second end
122 of filament 48 may then be secured to buckle 116 by inserting
second end 122 through opening 124 in buckle 116, looping end 122
around bar 126, and threading end 122 through second opening 128.
In this manner, filament 48 is looped back onto itself and retained
by friction within buckle 116. For large tears or damaged areas,
multiple devices may be implanted in accordance with the method
described hereinabove.
[0056] As shown in FIG. 19, in another exemplary embodiment, first
end 114 and second end 122 of filament 48 are secured, via knots
for example, to hooks 130. Hooks 130 are curved and terminate at
sharpened tips 132. At any time during the procedure, tips 132 are
inserted through the upper articulation surface 12 of meniscus 10.
Once conduit 70 is properly positioned and hooks 130 attached to
meniscus 10 via tips 132, filament 48 acts to fixate tear 22 and
secure conduit 70 in position, as described hereinabove.
[0057] In another exemplary embodiment, shown in FIG. 19A, first
end 114 and second end 122 of filament 48 are pulled tight through
top articulating surface 12 of meniscus 10. Knot 115 is tied using
first end 114 and knot 117 is tied using second end 122 to secure
the walls of tear 98 in mutual engagement. Due to the physical
properties of meniscus 10, knots 115, 117 will sink into top
articulating surface 12, preventing any damage to or pain in the
patient's knee. Similarly, any other securement method or device
disclosed herein may potentially be used atop top articulating
surface 12 to secure ends 114, 122 of filament 48 together and
fixate tissue in the desired position.
[0058] Additionally, in another exemplary embodiment shown in FIGS.
20-21, conduit 70 is positioned within meniscus 10 in a similar
manner as described hereinabove. To secure conduit 70 in position
within meniscus 10 and fixate tear 22 or regenerative or
replacement meniscus implant 134, shown in FIG. 21, slide 136 is
used. Slide 136 has a body with a bore extending therethrough and
flange 138 projecting from an end of the body of slide 136. First
end 114 of filament 48 is threaded through the bore of slide 136
toward flange 138. Second end 122 of filament 48 is then secured to
first end 114 of filament 48 via slipknot 140. By pulling first end
114 of filament 48 away from outer wall 106 of meniscus 10,
slipknot 140 moves toward outer wall 106 and pushes slide 136 into
meniscus 10. Once filament 48 is taught, flange 138 will contact
outer wall 106 of meniscus 10, preventing slipknot 140 from sliding
further. Slipknot 140 can then be tightened to secure ends 114, 122
of filament 48 together. Once secured, ends 114, 122 of filament 48
may be trimmed and the removed portion discarded.
[0059] While the devices of the present invention may be implanted
as an alternative to a meniscectomy, the devices may also be
implanted in native meniscus tissue or a regenerative or
replacement meniscus implant following a meniscectomy to encourage
and/or promote tissue regeneration and, when a regenerative or
replacement meniscus implant is used, the device may further fixate
the implant to the natural meniscus tissue, as shown in FIG. 21. As
shown in FIG. 21, regenerative or replacement meniscus implant 134
is fixated via filament 48 in position against natural meniscus 10.
Implant 134 further receives blood, biological factors, cells, and
other fluids from the red zone 16 of meniscus or, in another
embodiment shown in FIG. 18, from the synovium via conduit 70.
[0060] As shown in FIG. 13, two conduits 70, 70' are connected
together via filament 130. In connecting the conduits, a first end
of filament 142 is inserted through interior 38 of through bore 36
of conduit 70, pulled from aperture 42, and wrapped half way around
conduit 70. The end is then inserted through aperture 44, shown in
hidden lines in FIG. 10, and pulled from interior 38 of through
bore 36, as discussed in detail hereinabove. Filament 130 is then
inserted through interior 38' of through bore 36' of conduit 70',
pulled from aperture 42', and wrapped half way around conduit 70'.
The end is then inserted through aperture 44' and pulled from
interior 38' of through bore 36', as discussed in detail
hereinabove. The ends of filament 130 are then connected together
via slipknot 144, forming device 146. While two conduits are
depicted in FIG. 13, any number of conduits needed to facilitate
tissue regeneration and healing may be connected together.
Generally, as the size of the tear or damaged area increases, the
number of conduits needed to facilitate tissue regeneration and
healing will correspondingly increase.
[0061] By using multiple conduits, blood and/or other substances
can be delivered to multiple points along the plane of a tear or
damaged area of tissue and fixated by the tightening of only a
single filament. The insertion of device 146 will now be described
in detail. Conduits 70, 70' are inserted individually relative to
tear 148 using the same procedure discussed hereinabove with
respect to conduit 70 and tear 98. Once each conduit 70, 70' is
properly inserted, as shown in FIG. 14, filament 142 remains
partially exposed along top articulating surface 12 of meniscus 10.
Filament 142 is then tightened, by pulling end 150 of filament 142
away from top articulating surface 12 until the inner and outer
walls of tear 148 are in mutual engagement. The interference of top
articulating surface 12 of meniscus 10 with the tightening of
filament 142 secures conduits 70, 70' in their desired
positions.
[0062] In one exemplary embodiment, a knot (not shown) is used to
fix filament 142, and correspondingly secure device 146, in
position. In one exemplary embodiment, slip knot 144 is used to
retain filament 142 in the tightened position. To tighten filament
142, end 150 is pulled away from top articulating surface 12 of
meniscus 10 and, at the same time, slip knot 144 slides downwardly
toward top articulating surface 12. Once slip knot 144 is
tightened, excess filament 142 can be trimmed and discarded. Due to
the resilient nature of fibrocartilage tissue, filament 142 and
slipknot 144 will become integrated with meniscus preventing any
adverse effects, such pain or discomfort during articulation of the
condyles of the femur against top articulation surface 12 and
filament 142. In one embodiment, a series of devices 78, shown in
FIG. 10, may be utilized with a single tear. Each device 78 can
then be fixated in the manner discussed hereinabove providing
additional tension on tear 98, shown in FIG. 11, and placing knot
112 outside of the contact area of meniscus 10 and against outer
wall 106.
[0063] In another exemplary embodiment, conduit 160, shown in FIG.
22, includes filament 162 secured through apertures in projection
164. Projection 164 may be overmolded, as described in detail
above, or may allow for sliding movement of filament 162 within
projection 164. If sliding movement of filament 162 is allowed, end
166 of filament 162 could be pulled away from projection 164
drawing end 168 toward projection 164. In another embodiment,
projection 164 is replaced by apertures located adjacent one
another on the same side of conduit 160, i.e., along the axial
length of conduit 160. These apertures accept filament 162 in the
same manner as apertures 42, 44, described in detail above with
reference to FIGS. 7-10. The use of either projection 164 or the
apertures located on the same side of conduit 160 provides for
eccentric loading of conduit 160 when filament 162 finally secured,
which impedes pull out of conduit 160.
[0064] While this invention has been described as having a
preferred design, the present invention can be further modified
within the spirit and scope of this disclosure. This application is
therefore intended to cover any variations, uses, or adaptations of
the invention using its general principles. Further, this
application is intended to cover such departures from the present
disclosure as come within known or customary practice in the art to
which this invention pertains and which fall within the limits of
the appended claims.
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