U.S. patent application number 16/551471 was filed with the patent office on 2019-12-19 for tissue fixation system and method.
The applicant listed for this patent is P Tech, LLC. Invention is credited to Hank Bonutti, Peter M. Bonutti, Glen A. Phillips, Kevin Ruholl.
Application Number | 20190380703 16/551471 |
Document ID | / |
Family ID | 39686516 |
Filed Date | 2019-12-19 |
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United States Patent
Application |
20190380703 |
Kind Code |
A1 |
Bonutti; Peter M. ; et
al. |
December 19, 2019 |
TISSUE FIXATION SYSTEM AND METHOD
Abstract
A tissue fixation system is provided for dynamic and rigid
fixation of tissue. A fastener connected with an elongate fastening
member, such as a cable, wire, suture, rod, or tube, is moved
through a passage between opposite sides of tissue. A medical
device is used to secure the fastener to the elongate fastening
member. The medical device includes a tensioning mechanism for
tensioning the elongate fastening member. As crimping mechanism is
used to secure the fastener to the elongated member, where a
cutting mechanism cut the excess portion of the elongated
member.
Inventors: |
Bonutti; Peter M.;
(Manalapan, CA) ; Bonutti; Hank; (Bloomfield
Hills, MI) ; Ruholl; Kevin; (Teutopolis, IL) ;
Phillips; Glen A.; (Effingham, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
P Tech, LLC |
Effingham |
IL |
US |
|
|
Family ID: |
39686516 |
Appl. No.: |
16/551471 |
Filed: |
August 26, 2019 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15198151 |
Jun 30, 2016 |
10390817 |
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16551471 |
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14096859 |
Dec 4, 2013 |
9402668 |
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15198151 |
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12030728 |
Feb 13, 2008 |
8617185 |
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14096859 |
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60889605 |
Feb 13, 2007 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 17/8869 20130101;
A61B 2017/0462 20130101; A61B 17/82 20130101; A61B 17/683 20130101;
A61B 17/0401 20130101; A61B 2017/0496 20130101; A61B 2017/0417
20130101; A61B 2017/00893 20130101; A61B 17/0469 20130101; A61B
2090/064 20160201; A61B 17/8863 20130101; A61F 2002/0882
20130101 |
International
Class: |
A61B 17/04 20060101
A61B017/04; A61B 17/82 20060101 A61B017/82; A61B 17/88 20060101
A61B017/88; A61B 17/68 20060101 A61B017/68 |
Claims
1-9. (canceled)
10. A method of tensioning an elongate member, the method
comprising: looping the elongate member through a graft, wherein
the graft is configured to be secured to at least one of a first
tissue and a bone; passing at least one end of the elongate member
through at least one of a second tissue and bone; providing a
cannulated tensioning device comprising: a cannulated tube, having
a proximal end and a distal end, and defining a longitudinal
passage along a central longitudinal axis; a handle attached to the
proximal end of the cannulated tube, wherein the handle is
configured to allow the elongate member to pass through at least a
portion of the cannulated tube and the handle; and a tensioning
mechanism disposed on the handle of the tensioning device, the
tensioning mechanism comprising: a rotation assembly; at least one
biasing member configured to apply a tension force to the elongate
member; and a rotatable shaft positioned along an axis
perpendicular to and intersecting the axis defined by the
longitudinal passage of the cannulated tube, the rotatable shaft
having an open end slotted aperture; advancing the at least one end
of the elongate member through the cannulated suture tensioning
device; capturing and securing the elongate member in the slotted
aperture of the rotatable shaft of the tensioning mechanism; and
rotating the rotation assembly of the tensioning mechanism to apply
tension to the elongate member as the rotation assembly wraps the
elongate member around the rotatable shaft, thereby tightening the
elongate member and tensioning the graft.
11. The method of claim 10, further comprising the tensioning
mechanism having a locking assembly, wherein the locking assembly
of the tensioning mechanism is configured to at least one of
maintain tension in the elongate member and prevent reversing of
the rotation assembly.
12. The method of claim 10, wherein the elongate member is at least
one of a suture, thread, and cable.
13. The method of claim 12, wherein the elongate member is at least
one of threadlike, multifilament, braided, and interlaced and
comprised at least in part of polyethylene
14. The method of claim 10, further comprising tensioning the
elongate member with a surgical robotic mechanism.
15. The method of claim 10, further comprising a tension limiting
mechanism configured to restrict tensioning of the elongate member
beyond a desired tension limit.
16. The method of claim 10, wherein the system is configured to
secure a graft during anterior cruciate ligament surgery.
17. The method of claim 10, wherein the tensioning mechanism
further includes a torque controller.
18. The method of claim 10, wherein the rotation assembly includes
a knob.
19. The method of claim 10, further comprising measuring the
tension applied to the elongate member.
20. The method of claim 10, further comprising a crimping mechanism
positionable in the proximal end of the cannulated tube, the
crimping mechanism having at least one force application member
configured to apply at least one external compressive force to
reduce the aperture of a malleable fastener positionable in the
crimping mechanism to crimp the fastener to the elongate
member.
21. A method of tensioning an elongate member, the method
comprising: securing the elongate member to at least one of a
tissue, bone, graft, anchor, and implant; providing a cannulated
tensioning device comprising: a cannulated tube, having a proximal
end and a distal end, and defining a longitudinal passage along a
central longitudinal axis; a handle attached to the proximal end of
the cannulated tube, wherein the handle is configured to allow the
elongate member to pass through at least a portion of the
cannulated tube and the handle; and a tensioning mechanism disposed
on the handle of the tensioning device, the tensioning mechanism
comprising: a rotation assembly; at least one biasing member
configured to apply a tension force to the elongate member; and a
rotatable shaft positioned along an axis perpendicular to and
intersecting the axis defined by the longitudinal passage of the
cannulated tube, the rotatable shaft having an open end slotted
aperture; advancing the at least one end of the elongate member
through the cannulated suture tensioning device; capturing and
securing the elongate member in the slotted aperture of the
rotatable shaft of the tensioning mechanism; and rotating the
rotation assembly of the tensioning mechanism to apply tension to
the elongate member as the rotation assembly wraps the elongate
member around the rotatable shaft, thereby tightening the elongate
member against the at least one of a tissue, bone, graft, anchor,
and implant.
22. The method of claim 21, further comprising the tensioning
mechanism having a locking assembly, wherein the locking assembly
of the tensioning mechanism is configured to at least one of
maintain tension in the elongate member and prevent reversing of
the rotation assembly.
23. The method of claim 21, wherein the elongate member is at least
one of a suture, thread, and cable.
24. The method of claim 23, wherein the elongate member is at least
one of threadlike, multifilament, braided, and interlaced and
comprised at least in part of polyethylene
25. The method of claim 21, further comprising tensioning the
elongate member with a surgical robotic mechanism.
26. The method of claim 21, further comprising a tension limiting
mechanism configured to restrict tensioning of the elongate member
beyond a desired tension limit.
27. The method of claim 21, wherein the system is configured to
secure the at least one tissue, bone, graft, and implant during
anterior cruciate ligament surgery.
28. The method of claim 21, wherein the tensioning mechanism
further includes a torque controller.
29. The method of claim 21, wherein the rotation assembly includes
a knob.
30. The method of claim 21, further comprising measuring the
tension applied to the elongate member.
31. The method of claim 21, wherein the implant is at least one of
a plate, anchor, and button.
32. The method of claim 21, wherein the tissue is at least one of a
graft, bone, cartilage, ligament and tendon.
33. The method of claim 21, further comprising a crimping mechanism
positionable in the proximal end of the cannulated tube, the
crimping mechanism having at least one force application member
configured to apply at least one external compressive force to
reduce the aperture of a malleable fastener positionable in the
crimping mechanism to crimp the fastener to the elongate member.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims priority to U.S. Provisional Patent
Application No. 60/889,605, entitled Tissue Fixation System and
Method, filed on Feb. 13, 2007, the contents of which are
incorporated herein by reference in their entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a system and method for fixation
and stabilization of tissue. In particular, the invention relates
to minimally invasive bone fracture fixation and stabilization.
BACKGROUND OF THE INVENTION
[0003] It is well-known in the medical arts that applying pressure
to tissue helps during the healing process. Incised or torn soft
tissue, for example, may be approximated with bandages, sutures, or
staples. Proper and more rapid healing of broken or fractured bones
likewise may be facilitated by applying constant pressure to the
bone. For instance. physicians may insert pins, screws, or bolts in
the area of the fracture in order to apply pressure to the
fracture.
[0004] However, inserting screws through or around fractures can be
complex and time-consuming. For example, the process of inserting a
screw typically involves multiple steps conducted from multiple
incisions or openings that provide access to the treated bone or
tissue, including the steps of drilling holes, measuring the
relevant distances to determine the appropriate screw selection,
tapping the hole to establish threads, and screwing the screw into
the hole.
[0005] In addition to the length and complexity of the process,
bone screws also may lose their grip and strip out of the bone. In
addition, currently available lag screws also typically provide
only one side of cortex fixation and are generally not suited for
percutaneous surgery. Moreover, when placing the screws in the
bone, the physician may not accurately set the screw into the
distal hole or may miss the distal hole completely, thereby
resulting in the screw stripping the threads or breaking the
bone.
[0006] Many devices and instruments have been disclosed to fasten
soft and hard tissue for enhanced healing or tissue reconstruction.
Examples of such devices include bone plates, bone wraps, external
bone supports, and the like.
[0007] For example, U.S. Pat. No. 5,921,986, the contents of which
are incorporated herein by reference, discloses a bone suture and
associated methods for implantation and fracture fixation. The '986
patent describes fasteners and anchors used in conjunction with an
elongate fixation element, such as a suture. In some cases, it may
be advantageous to use more rigid fixation elements.
[0008] Accordingly, a need exists for a tissue fixation instrument
which can provide flexible or rigid fixation of tissue while
accessing the tissue from a small skin portal.
SUMMARY OF THE INVENTION
[0009] The present invention relates to a tissue fixation system.
The system comprises an elongate fastening member and a fastener
moveable with respect to the elongate fastening member from a first
orientation to a second orientation, the fastener having a body
with a tissue contacting surface that includes a groove configured
and dimensioned to receive a portion of the elongate member in the
first orientation. The system can also include a second fastener or
other means for maintaining tension in the elongate fastening
member.
[0010] A biasing means can be provided to maintain the fastener in
the first orientation. The biasing means can be an adhesive between
the groove and the portion of the elongate fastening member
received in the groove. The biasing means could also be a frangible
connection between the groove and the portion of the elongate
fastening member received in the groove.
[0011] The fastener body can have a free surface opposite the
tissue contacting surface, with the free surface including a
channel configured and dimensioned to receive a portion of the
elongate member in the first orientation. The fastener body can
also include a through bore extending from the tissue contacting
surface through the free surface.
[0012] In one embodiment, the fastener body includes leading and
trailing ends. The leading end can be tapered or otherwise shaped
to facilitate insertion. The groove terminates at the through bore
and extends toward one of the leading and trailing ends and the
channel terminates at the through bore and extends toward the other
of the leading and trailing ends. In an exemplary embodiment, the
groove extends toward the leading end and the channel extends
toward the trailing end.
[0013] The free surface of the fastener body can be provided with a
well surrounding the through bore. The well can be configured and
dimensioned to receive at least a portion of the stop. A distal end
of the elongate fastening member can include a stop larger than the
through bore.
[0014] The present invention also relates to a medical instrument
or device for securing the fastener with respect to the elongate
fastening member. The medical device tensions the elongate
fastening member and crimps either the fastener or a bushing.
Another aspect of the invention relates to methods of tissue
fixation using the disclosed tissue fixation systems.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] A more complete understanding of the present invention, and
the attendant advantages and features thereof, will be more readily
understood by reference to the following detailed description when
considered in conjunction with the accompanying drawings
wherein:
[0016] FIG. 1 shows a schematic illustration of a tissue fixation
system according to the present invention utilized for fracture
fixation;
[0017] FIG. 2 shows a perspective view of a fastener according to
the present invention;
[0018] FIG. 3 shows a side view of the fastener of FIG. 2;
[0019] FIG. 4 shows a bottom view of the fastener of FIG. 2;
[0020] FIG. 5 shows a top view of the fastener of FIG. 2;
[0021] FIG. 6 shows a fastener and elongate fastening member with
the fastener in a first orientation with respect to the elongate
fastening member.
[0022] FIG. 7 shows a front view of a fastener in the first
orientation with respect to the elongate fastening member with the
fastener rotated 180.degree. compared to FIG. 6;
[0023] FIG. 8 shows a back view of the fastener and elongate
fastening member of FIG. 7;
[0024] FIG. 9A shows an elongate fastening member according to the
present invention;
[0025] FIG. 9B shows an elongate fastening member including
expandable members;
[0026] FIG. 10 shows a fastener in a second orientation with
respect to an elongate fastening member;
[0027] FIG. 11 shows a cannulated drill system used to create a
passage through the tissue to be fixed;
[0028] FIG. 12 shows a sleeve having a lumen through which the
fixation system can be passed;
[0029] FIG. 13 shows a distal fastener being inserted into the
sleeve;
[0030] FIG. 14 shows a pushrod used to move the distal fastener
through the sleeve;
[0031] FIG. 15 shows the distal fastener in the second
orientation;
[0032] FIG. 16 shows a proximal fastener being used to maintain the
tension in the elongate fastening member;
[0033] FIG. 17 depicts a front isometric view of a medical device
in accordance with the present invention;
[0034] FIG. 18 depicts a sectional view showing the tensioning
mechanism of the medical device of FIG. 17;
[0035] FIG. 19 depicts a side isometric view showing the tensioner
housing of the medical device of FIG. 17;
[0036] FIG. 20 depicts an exploded view of the locking assembly of
the medical device of FIG. 17;
[0037] FIG. 21 depicts a rear isometric view of the locking
assembly of the medical device of FIG. 17;
[0038] FIG. 22 depicts an exploded view of the rotation assembly of
the medical device of FIG. 17;
[0039] FIG. 23 depicts partial isometric view of the connection of
the rotation assembly of FIG. 22 to the locking assembly of FIG.
21;
[0040] FIG. 24 depicts a partial front exploded view of the torque
controller of the tensioning mechanism;
[0041] FIG. 25 depicts a partial rear exploded view of the torque
controller of the tensioning mechanism;
[0042] FIG. 26 depicts a partial front isometric view of the
rotation assembly of FIG. 22;
[0043] FIG. 27 depicts a front isometric view of the collet of the
medical device of FIG. 17;
[0044] FIG. 28 depicts a partial sectional view of the crimping
mechanism of the medical device of FIG. 17;
[0045] FIG. 29 depicts an partial sectional view of the crimping
mechanism of the medical device of FIG. 17;
[0046] FIG. 30 depicts a partial isometric view showing the cutting
mechanism of the medical device of FIG. 17;
[0047] FIG. 31 depicts a partial sectional view showing the cutting
mechanism of FIG. 30;
[0048] FIG. 32 depicts the locking mechanism of the medical device
of FIG. 17;
[0049] FIG. 33 depicts a partial isometric view showing the handle
portion of the cutting mechanism;
[0050] FIG. 34 depicts a safety lock of the medical device of FIG.
17; and
[0051] FIG. 35 depicts a stroke limiter of the cutting
mechanism.
DETAILED DESCRIPTION OF THE INVENTION
[0052] The present invention provides a tissue fixation system for
dynamic and rigid fixation of tissue. The system can be utilized
for the fixation and stabilization of body tissue, including soft
tissue to soft tissue, soft tissue to bone, and bone to bone. The
surgical system can additionally be used to affix implants and
grafts to body tissue. The system can access and treat fractured,
incised or torn tissue, or the like, from one access area (i.e.,
from only one opening to the tissue to be fastened) instead of
requiring two or more openings. That is, the system is a linear
fixation system that can be used with a single, small incision or
portal in the skin or other soft tissue to gain access to the
fractured bone. The fixation system may be an all-in-one system,
packaged as a system kit, for creating a passage in tissue,
positioning fasteners, and tensioning an elongate fastening member,
like a suture, thread, cable, wire, rod, or pin. The individual
components of the system can either be reusable or single use
components.
[0053] Referring now to the drawing figures in which like reference
designators refer to like elements, FIG. 1 shows an exemplary
embodiment of a tissue fixation system 100 according to the present
invention. A fractured portion 102 of a bone 104 is approximated by
system 100. Use of system 100 is not limited to any particular type
of fracture. Furthermore, use of system 100 is not limited to
fracture fixation. In other words, system 100 can be utilized for
other tissue fixation applications (such as soft tissue) or similar
clinical indications. Examples of such tissue includes, are not
limited to, muscle, cartilage, ligament, tendon, skin, etc. Also,
the tissue may be stomach tissue, and the system may be used during
bariatric surgery, as in stomach stapling. Additionally, the system
100 can be used for the fixation of implants to tissue.
[0054] In this regard, the present invention may be used in
conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured following intervertebral disc
surgery, knee surgery, hip surgery, organ transplant surgery,
bariatric surgery, spinal surgery, anterior cruciate ligament (ACL)
surgery, tendon-ligament surgery, rotator cuff surgery, capsule
repair surgery, fractured bone surgery, pelvic fracture surgery,
avulsion fragment surgery, hernia repair surgery, and surgery of an
intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor
tendons, etc. In one particular application, an anastomosis is
performed over a balloon and the methods and devices of the present
invention are used to repair the vessel.
[0055] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sacpouch, collagen, or
gelatin, or a rigid implant made of metal, polymer, composite, or
ceramic. Other implants include breast implants, biodegradable
plates, porcine or bovine patches, metallic fasteners, compliant
bearing for medial compartment of the knee, nucleus pulposus
prosthetic, stent, tissue graft, tissue scaffold, biodegradable
collagen scaffold, and polymeric or other biocompatible scaffold.
The scaffold may include fetal cells, stem cells, embryonal cells,
enzymes, and proteins.
[0056] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0057] Although the invention is described primarily on a
macroscopic level, it is also envisioned that the present invention
can be used for microscopic applications. For example, in the
repair of nerve tissue, individual cells or fibers may need to be
repaired. Similarly, muscle repair may require tightening of
individual muscle fibers.
[0058] System 100 includes a distal fastener 106 contacting
fracture portion 102, a proximal fastener 108 contacting bone 104,
and an elongate fastening member 110 extending through the fracture
and coupling distal and proximal fasteners 106, 108. Tension is
maintained in elongate fastening member 110 to press fasteners 106,
108 against opposite sides of bone 104 with a desired force. This
force presses fracture portion 102 against bone 104 firmly together
to promote healing of the fracture. If desired, buttons or other
force distributing members could be provided between fasteners 106,
108 and the bone. Although FIG. 1 shows distal and proximal
fasteners 106, 108 as having the same construction, they could have
differing construction. However, for convenience and practical
purposes, it may be beneficial if distal and proximal fasteners 106
and 108 have substantially the same construction.
[0059] FIGS. 2-5 show an exemplary embodiment of a fastener 112
that can be used as part of system 100, i.e. as either or both of
distal and proximal fasteners 106, 108. Fastener 112 has a body 114
that is configured and dimensioned to facilitate implantation
through minimally invasive procedures, e.g. through a cannula or
sleeve. In particular, body 114 includes a tissue contacting
surface 116 that is provided with groove 118 that receives a
portion of elongate fastening member 110 when fastener 112 is in a
first orientation with respect to elongate fastening member 110.
This is seen in FIG. 6. The accommodation of elongate fastening
member 110 within groove 118 helps to minimize the profile of the
assembly of fastener 112 and elongate fastening member 110. The
reduced profile can be more readily passed through a cannula or
sleeve. If desired, an adhesive can be provided within groove 118
to bias fastener 112 in the first orientation. Alternatively, a
frangible connection can be provided between groove 118 and a
portion of elongate fastening member 110, operative to keep
fastener 112 in the first orientation with respect to elongate
fastening member 110, until the frangible connection is broken,
when desired.
[0060] Fastener 112 is provided with first and second ends 120,
122. As shown in FIG. 6, first end 120 is the leading end and
second end 122 is the trailing end. In this position, when fastener
112 is pivoted to a second orientation, like distal fastener 106 of
FIG. 1, tissue contacting surface 116 is in contact with the
tissue. As shown in FIGS. 7 and 8, second end 122 is the leading
end and first end 120 is the trailing end. In this position, when
fastener 112 is pivoted to the second orientation, like proximal
fastener 108 of FIG. 1, tissue contacting surface 116 is in contact
with the tissue.
[0061] Fastener body 114 has a free surface 124 opposite tissue
contacting surface 116. Free surface 124 is provided with a channel
126 that receives a portion of elongate fastening member 110 when
fastener 112 is in a first orientation with respect to elongate
fastening member 110. As shown in FIGS. 7 and 8, fastener 112 is
being slid along elongate fastening member 110. In particular, a
through bore 128 extends from tissue contacting surface 116 through
free surface 124. Through bore 128 is larger in diameter than
elongate fastening member 110 so that fastener 112 freely slides
along elongate fastening member 110. A portion of elongate
fastening member 110 fits within channel 126 on free surface 124
and a portion of elongate fastening member 110 fits within groove
118 on tissue contacting surface 116.
[0062] Fastener body 114 is shown with first end 120 having a
substantially flat profile and second end 122 having a tapered
profile. In general, any suitable external configuration can be
used for fastener 112. Examples of fasteners may be found in U.S.
Pat. Nos. 5,163,960; 5,403,348; 5,464,426; 5,549,630; 5,593,425;
5,713,921; 5,718,717; 5,782,862; 5,814,072; 5,814,073; 5,845,645;
5,921,986; 5,948,002; 6,010,525; 6,045,551; 6,159,234; 6,368,343;
6,447,516; 6,475,230; 6,592,609; 6,635,073; and 6,719,765. Other
fastener types are disclosed in U.S. patent application Ser. Nos.
10/102,413; 10/228,855; 10/779,978; 10/780,444; 10/797,685, and
11/358,331. The above cited patents and patent applications are
hereby incorporated by reference.
[0063] Fastener 112 can be made of any biocompatible material
suitable for a given application. For example, the fasteners may
be, but are not limited to, degradable, biodegradable, bioerodible,
bioabsorbable, mechanically expandable, hydrophilic, bendable,
deformable, malleable, riveting, threaded, toggling, barbed,
bubbled, laminated, coated, blocking, pneumatic, one-piece,
multi-component, solid, hollow, polygon-shaped, pointed,
self-introducing, and combinations thereof. Also, the fasteners may
include metallic material, polymeric material, ceramic material,
composite material, body tissue, synthetic tissue, hydrophilic
material, expandable material, compressible material, heat bondable
material, and combinations thereof. Examples of body tissue include
bone, collagen, cartilage, ligaments, or tissue graft material like
xenograft, allograft, and autograft. The fasteners may also be made
from a porous matrix or mesh of biocompatible and bioresorbable
fibers acting as a scaffold to regenerate tissue.
[0064] The fasteners may further be made of or have a coating made
of an expandable material. The material could be compressed then
allowed to expand. Alternatively, the material could be hydrophilic
and expand when it comes in contact with liquid. Examples of such
expandable materials are ePTFE and desiccated body tissue.
[0065] Moreover, the fasteners described herein and incorporated by
reference may include therapeutic substances to promote healing.
These substances could include antibiotics, hydroxyapatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein (BMP),
demineralized bone matrix, collagen, growth factors, autogenetic
bone marrow, progenitor cells, calcium sulfate, immo suppressants,
fibrin, osteoinductive materials, apatite compositions, germicides,
fetal cells, stem cells, enzymes, proteins, hormones, cell therapy
substances, gene therapy substances, and combinations thereof.
These therapeutic substances may be combined with the materials
used to make the fasteners to produce a composite fastener.
Alternatively, the therapeutic substances may be impregnated or
coated on the fastener. Time-released therapeutic substances and
drugs may also be incorporated into or coated on the surtface of
the fastener. The therapeutic substances may also be placed in a
bioabsorbable, degradable, or biodegradable polymer layer or
layers.
[0066] FIG. 9A shows an exemplary embodiment of an elongate
fastening member 130. Elongate fastening member 130 includes a body
132 and has a stop 134 at a distal end. Body 132 can be selected
for a given application. For example, if a rigid elongate fastening
member 130 is needed, body 132 can be a rod or a tube. If a more
flexible elongate fastening member 130 is needed, body 132 can be a
suture. In general, a wire analogous to those used for cerclage of
bone fractures is believed to provide a suitable combination of
strength and flexibility. Although body 132 is shown as a single
strand wire, the invention can be used with any type of surgical
cable, such as a multi-strand cable.
[0067] Stop 134 can be made integral with body 132 or separate and
then attached. Stop 134 is larger in diameter than through bore 128
in body 114 of fastener 112. Thus, once stop 134 reaches through
bore 128, fastener 112 cannot be slid any further along elongate
fastening member 130. As shown in FIG. 5, free surface 124 of
fastener 112 is provided with a well 136 surrounding through bore
128. Well 136 is configured and dimensioned to receive at least a
portion of stop 134. As shown in FIG. 10, this helps reduce the
profile of the assembly when fastener 112 is in a second
orientation with respect to elongate fastening member 130.
[0068] Referring to FIG. 9B, in another embodiment, the elongated
fastener member 130 includes expandable members 131, positioned
along the body 132. Upon insertion into the tissue, the expandable
members 131 expand to engage the surrounding tissue. For examples,
the expandable members 131 can be barbs. The barbs 131 engage the
surrounding tissue, maintaining elongated fastener member's 130
position within the tissue.
[0069] The elongate fastening members of the present invention may
be made of metallic material, non-metallic material, composite
material, ceramic material, polymeric material, co polymeric
material, or combinations thereof. The members may be degradable,
biodegradable, bioabsorbable, or nonbiodegradable. Examples of
suture materials that can be used for the elongate fastening
members are polyethylene, polyester, cat gut, silk, nylon,
polypropylene, linen, cotton, and copolymers of glycolic and lactic
acid. Preferably, the members are flexible or bendable. They may be
threadlike, monofilament, multifilament, braided, or interlaced.
The members may have a coating of therapeutic substances or drugs.
For example, the members may include antibiotics, hydroxyapatite,
anti-inflammatory agents, steroids, antibiotics, analgesic agents,
chemotherapeutic agents, bone morphogenetic protein, demineralized
bone matrix, collagen, growth factors, autogenetic bone marrow,
progenitor cells, calcium sulfate, immo suppressants, fibrin,
osteoinductive materials, apatite compositions, fetal cells, stem
cells, enzymes, proteins, hormones, and germicides.
[0070] The use of the tissue fixation system according to the
present invention will now be described using fracture fixation as
an example. If necessary, the fracture is reduced bringing fracture
portion 102 into contact with bone 104 (FIG. 11). The reduction can
be achieved using any number of techniques.
[0071] As also shown in FIG. 11, a drill system 138 is used to
drill across the fracture, thereby creating a passage completely
through bone 104. Drill system 138 includes a drill bit 140 with a
headpiece configured for attachment to a drill. A drill stop can be
placed on the headpiece and prevents drill bit 140 from penetrating
too far beyond the tissue to be drilled. Drill system 138 may be a
cannulated drill system that fits over a k-wire or other similar
guide wire. A cannula or sleeve 142 may encircle drill bit 140 or
at least the shaft portion of drill bit 140. As drill bit 140
creates a passage through bone 104, sleeve 142 is positioned in the
passage. Drill system 138 is used to create a passage in bone 104
from the proximal side of bone 104 to the distal side of bone 104,
then the drill and drill bit 140 are removed from sleeve 142 (FIG.
12).
[0072] As shown in FIG. 13, a distal fastener 112a is inserted into
sleeve 142. Distal fastener 112a is inserted in the first
orientation with respect to elongate fastening member 130 with
first end 120 as the leading end. In this configuration, tissue
contacting surface 116 will be in contact with fracture portion 102
when distal fastener 112a is pivoted into the second orientation.
This is best seen in FIGS. 14 and 15, in which a pushrod 144 is
used to advance distal fastener 112a and elongate fastening member
130 through sleeve 142. Pushrod 144 also facilitates the pivoting
of distal fastener 112a from the first orientation to the second
orientation. This pivoting is not possible until distal fastener
112a has exited through sleeve 142. Also, because the length of
distal fastener 112a is larger than the passage created in bone
104, pulling back on elongate fastening member 130 helps to ensure
distal fastener 112a is in the second orientation and flush against
fracture portion 102.
[0073] As illustrated in FIG. 16, sleeve 142 is removed from bone
104. Fastener 112a is located on the distal side of bone 104.
Elongate fastening member 130 extends from fastener 112a through
the bone passage and out the proximal opening of the bone or tissue
passage. Any suitable means can be used to keep distal fastener
112a against fracture portion 102 with tension, where the tension
can be measure and controlled in accordance with use. For example,
elongate fastening member 130 can be deformed at the proximal end
of the passage such that the deformed section rests against bone
104. The deformation would depend on the nature of elongate
fastening member 130. If elongate fastening member 130 is a
relatively flexible element, such as a suture, cable, or wire, then
simply tying a knot in fastening member 130 could be sufficient to
maintain the tension. If elongate fastening member 130 does not
allow a knot, such as would be the case with a rod or tube, then
mechanical deformation of elongate fastening member 130 to create
an enlarged head could be sufficient to maintain the tension. U.S.
Patent Application Publication No. US 2002/0016593, the contents of
which are incorporated herein by reference, discloses mechanisms to
mechanically deform an extension member and could be used to deform
elongate fastening member 130.
[0074] Alternatively, the elongated fastening member 130 can be
deformed by an energy source, such as thermal energy, to deform
elongate fastening member 130 to create an enlarged head sufficient
to maintain the tension.
[0075] In an exemplary embodiment, a proximal fastener 112b is used
to secure distal fastener 112a and elongate fastening member 130.
In this embodiment, proximal fastener 112b is identical to distal
fastener 112a. If not already pre-loaded, proximal fastener 112b is
loaded onto elongate fastening member 130. Proximal fastener 112b
is loaded as shown in FIGS. 7 and 8, i.e. with second end 122 as
the leading end so that after proximal fastener 112b is slid down
against bone 104 and pivoted into the second orientation, tissue
contacting surface 116 is in contact with bone 104.
[0076] Elongate fastening member 130 is tensioned, and proximal
fastener 112b is secured to elongate fastening member 130 to
thereby approximate the fracture and stabilize bone 104. The
tension of elongate fastening member 130 pulls on distal and
proximal fasteners 112a, 112b generally toward each other, thereby
applying pressure to the fractured bone or tissue. In this regard,
a bushing 146 can be used to secure proximal fastener 112b with the
desired tension. Single or multiple elongated members 130 can be
used to secure the fractured bone or tissue.
[0077] Although a number of mechanisms can be used to secure
bushing 146, an instrument or medical device particularly useful
for this will now be described.
[0078] In this regard, the present invention also provides a
medical device for securing a fastener against relative movement
with respect to a cable. As previously disclosed, a cable and pair
of oppositely spaced fasteners can be used to secure a bone
fracture. The cable is passed through the bone and fracture; a
first fastener secures the cable on a first side (fracture side) of
the bone; and a second fastener is positioned about the cable on a
second side of the bone, opposite the first fastener. A bushing is
positioned onto the cable to secure the second fastener against the
second side of the bone. A force is applied to the bushing,
compressing the second fastener against the second side of the bone
and providing a tension to the cable. The tension in the cable can
be measured and controlled, for example, with the use of a sensor
and spring element. The spring can apply the force to tension the
cable, and the sensor can be used to measure the resulting tension.
Alternatively, the sensor can measure the compression of the tissue
to determine the tension. The bushing is crimped about the cable,
securing the second fastener against the second side of the bone,
such that a tension is provided through the cable between the first
and second fasteners.
[0079] Referring now to FIG. 17, a medical device 200 in accordance
with an embodiment of the invention is provided for securing the
bushing to the cable. Medical device 200 includes handle portion
202 having a tensioning mechanism 204, operative to tension cable
110/132 and apply a force to bushing 146, and a crimping mechanism
206 operative to securing bushing 146 to cable 110 or 132 of system
100 or member 130.
[0080] With additional reference to FIG. 18, tensioning mechanism
204 includes collet holder 208 defining a longitudinal passage
along a central longitudinal axis A-A. Collet holder 208 is fixedly
positioned through top portion 212 of handle portion 202, secured
by collet holder pin 214. A cable tensioner 216 is positioned
proximal to a first end 218 of the collet holder 208. Cable
tensioner 216 includes rotatable shaft 220 aligned with the
longitudinal passage of the collet holder 208. Rotatable shaft 220
includes a cable aperture 222 (visible in FIGS. 20,21) for
threading the cable therethrough, wherein cable 132 is wrapped
about rotatable shaft 220 to thereby prevent relative movement
between cable 132 and cable tensioner 216.
[0081] Referring to FIG. 19, tensioner housing 226 is affixed to
first portion 228 of handle portion 202. Tensioner housing 226
includes recess 230, configured for receiving tensioning assembly
232 of cable tensioner 216, wherein rotatable shaft 220 extends
through center hole 231 in tensioner housing 226.
[0082] Referring to FIGS. 20 and 21, tensioning assembly 232
includes locking assembly 234. Locking assembly 234 includes inner
housing 238, which is press fit into recess 230 of tensioner
housing 226 when assembled. Inner housing 238 is sized and
dimensioned to prevent rotation of inner housing 238 with respect
to tensioner housing 226. Output shaft 240 is positioned partly
within inner housing 238, and includes rotatable shaft 220 and
shaft head 242. Output shaft 240 is positioned such that rotatable
shaft 220 is extended through center hole 231 in tensioner housing
226, and shaft head 224 is positioned within inner housing 238.
[0083] Roller bearings 246 are positioned between an outer raised
surface 248 of shaft head 242 and inner surface 250 of the inner
housing 238. The roller bearings 246 are fitted between shaft head
242 and inner housing 238, to allow rotation of output shaft 240
with respect to inner housing 238.
[0084] Outer raised surface 248 of shaft head 242 is provided in a
substantially triangular configuration, having, in the embodiment
shown, three sets of pairs of oppositely inclined surfaces, as
represented by surfaces 247,249. Roller bearings 246 are
positioned, one each, between inclined surfaces 247,249 and inner
surface 250 of inner housing 238, such that a rotation of shaft
head 250 will pinch or compress roller bearings 246 between
inclined surfaces 247,249 and inner surface 250. In this manner,
shaft head 242 and output shaft 240 become rotationally locked
together, and are mutually prevented from rotating with respect to
inner housing 238. As such, no external torsional force is required
to produce a locking coupling. In either direction of rotation,
clockwise or counter clockwise, at least three roller bearings 246
will be pinched, locking shaft head 242 and output shaft 240 from
rotational movement.
[0085] Inner extensions 254 of cam plate 252 are positioned between
inner surface 250 of inner housing 238 and shaft head 242. Inner
extensions 254 include raised portions 256 configured to engage
notched sections 258 of shaft head 242, locking the cam plate 252
to output shaft 240, such that rotation of cam plate 252 will
rotate output shaft 240. In this manner, cam plate 252 is
rotationally coupled to output shaft 240.
[0086] Inner extensions 254 are further operative to unlock shaft
head 242 and output shaft 240. Specifically, when cam plate 252 is
rotated, inner extensions 254 dislodge and prevent pinching of
roller bearings 246, thus allowing rotation of shaft head 242 and
output shaft 240. When rotation of cam plate 252 in discontinued,
roller bearings 246 will again be allowed to be pinched, locking
shaft head 242 and output shaft 240.
[0087] Cam plate 252 further includes radial flange 260 disposed
about an outer circumference. Retaining ring 262 is positioned over
cam plate 252, engaging flange 260 and affixed to tensioner housing
226. In this manner, cam plate 252, output shaft 240, roller
bearings 246, and inner housing 238 are secured within recess 231
of tensioner housing 226 by retaining ring 262. Engagement of
flange 260 and retaining ring 262 secures cam plate 252 in
position, yet allows for rotation of cam plate 252 with respect to
tensioner housing 226.
[0088] Referring to FIG. 22, tensioning assembly 232 further
includes rotation assembly 236. Rotation assembly 236 includes
winding knob 270 defining knob recess 272. Biasing member 274 is
positioned in knob recess 272, where compression plate 276 is
positioned over biasing member 274. Locking collar 278 is
positioned through the bottom of winding knob 270, extending
through biasing member 274 such that extensions 280 of locking
collar 278 are positioned in alignment holes 282 of compression
plate 276.
[0089] Referring also to FIG. 23, rotation assembly 236 is affixed
to locking assembly 234 by attachment of locking collar 278 to cam
plate 252. Locking collar 278 is positioned to overlap upper collar
portion 284 of cam plate 252, wherein upper collar portion 284
extends through locking collar 278. Flanged portion 286 of locking
collar 278 is affixed to top surface 287 of cam plate 252. Locking
collar 278 can be affixed to cam plate 252 with screws, rivets,
welding, or other mechanical or chemical means.
[0090] The combined locking collar 278 and upper collar portion 284
of cam plate 252 extend through the bottom of winding knob 270,
extending through biasing member 274 and engaging alignment holes
282 of compression plate 276. An adjustment bolt 288 is positioned
through compression plate 276, threadably engaging threaded hole
289 (not visible) in cam plate 252, securing rotation assembly 236
to locking assembly 234.
[0091] Connection of rotation assembly 236 to locking assembly 234
includes an automatic torque control, Referring to FIGS. 24 and 25,
top surface 287 of cam plate 252 includes a plurality of raised
radial sections 292. Bottom surface 294 of winding knob 270
includes a plurality of mating notched sections 296 (not visible),
one for each of the raised radial sections 292 of cam plate 252.
Raised radial sections 292 and notched section 296 are configured
to engage each other, whereby rotation of winding knob 270 will
cause engagement of sections 292,296 to cause rotation of cam plate
252.
[0092] Winding knob 270 is urged into engagement with cam plate 252
by biasing member 274. Force applied by biasing member 274 can be
controlled by rotating adjustment bolt 288. Tightening of
adjustment bolt 288 urges compression plate 276 onto biasing member
274, increasing force applied between them. Loosening of adjustment
bolt 288 raises compression plate 276 away from biasing member 274,
decreasing applied force.
[0093] In use, biasing member 274 applies force to winding knob
270, forcing winding knob 270 into engagement with cam plate 252.
Applied force is translated to a desired tension in cable 132.
Torsional force is applied to winding knob 270 during rotation of
winding knob 270, wrapping cable 132 about rotatable shaft 220,
increasing tension in cable 132. At tensions less than a desired
tension, applied force is sufficient to maintain engagement between
winding knob 270 and cam plate 252.
[0094] However, at tensions greater then a desired tension, applied
force is insufficient to maintain engagement between winding knob
270 and cam plate 252. As such, as an increased torque is applied
to winding knob 270, winding knob 270 and cam plate 252 will lose
engagement, wherein notched sections 296 of winding knob 270 will
skip over raised radial sections 292 of cam plate 252. In this
manner, tension greater then a desired tension cannot be applied to
cable 132. Furthermore, locking assembly 234 prevents reversing, or
backing off of cam plate 252, thus maintaining tension in cable
132.
[0095] Referring to FIG. 26, cover plate 297 can be positioned over
and affixed to compression plate 276, cover plate 297 can include
limit stop 298, for limiting maximum allowable tension on cable.
Thumb cap 300 can be attached to the head of adjustment bolt 288 to
facilitate adjustment. Thumb cap 300 is designed to engage limit
stop 298, thus preventing an over adjust of adjustment bolt
288.
[0096] Cover plate 297 can include tension indicating markings to
indicate desired tension to be applied to cable 132. Thumb cap 300
is rotated to a desired tension, as indicated by the markings,
enabling a user to select a desired tension based on cable
strength, or may be used to prevent over tensioning or snapping of
cable 132.
[0097] Referring to FIGS. 18 and 27, collet 310 is affixed to
second end portion 312 of collet holder 208, opposite cable
tensioner 216. Collet 310 defines a collet passage longitudinally
aligned with the longitudinal passage of collet holder 208, along
central longitudinal axis A-A. An end portion of collet 310 is
bisected, forming first and second collet arms 314 and 316. Gap
portion 318 is provided between first and second collet arms 314
and 316. Each of first and second collet arms 314 and 316 include
force application end portions 320 and 322, force application end
portions 320 and 322, combine to form bushing aperture 324
configured to received bushing 146 therein. Collet 310 is made of a
semi-rigid material, such that first and second collet arms 314 and
316 can be moved from an open to closed position, closing gap 318
and bushing aperture 324 between force application end portions 320
and 322.
[0098] In use, tensioning mechanism 204 is used to tension cable
132. As discussed above, cable 132 can include single or multiple
filaments. Cable 132 is inserted through medical device 200 along
central longitudinal axis A-A, through collet 310, collet holder
208, and cable tensioner 216, positioning bushing in bushing
aperture 324 and extending cable through cable aperture 222. To
tension cable, winding knob 270 is rotated until a desired tension
is achieved. Desired tension can be selected by setting thumb cap
300 to the desired tension marking.
[0099] Referring again to FIGS. 17 and 28, crimping mechanism 206
includes an outer tube 330 slideably positioned over collet holder
208. Outer tube 330 includes first end 332 operably connected to
trigger 334 and second end 336 connected to collet closer 338.
Trigger 334 is pivotally mounted in handle portion 202, such that
trigger 334 can be actuated from first trigger position TR1 to
second trigger position TR2. With additional reference to FIG. 32,
locking mechanism 370 can be included, in accordance with one
embodiment of the invention, which prevents trigger 334 from being
accidentally actuated. Locking mechanism 370 is disengaged by
rotating it away from handle, where locking mechanism 370 is
secured to trigger with locking pawl 371.
[0100] With reference to FIG. 28, operable connection between first
end of outer tube 332 and trigger 334 includes an outer tube
ferrule engagement member 342 slidably positioned about collet
holder 208 and engaging first end 332 of outer tube 330. Tube bias
member 344 is interposed between handle portion 202 and outer tube
ferrule 332, such that tube bias member 344 biases outer tube
ferrule 332 and outer tube 330 into a first tube position P1 (FIG.
29). An upper trigger portion 346 includes first edge 348, where
first edge 348 engages outer tube ferrule engagement member 342
when trigger 334 is actuated from first trigger position TR1 to
second trigger position TR2.
[0101] First edge 348 engagement of outer tube ferrule 332 moves
outer tube ferrule 332 and outer tube 330 along collet holder 208
from a first tube position P1 to a second tube position P2. As
trigger 334 is released, tube bias member 344 biases outer tube
ferrule 332 and outer tube 33 from second tube position P2 to first
tube position P1. Simultaneously, trigger 334 is moved to first
trigger position TR1.
[0102] Referring to FIGS. 17 and 29, collet closer 338 is
positioned on outer tube 330 proximal to the force application end
portions 320 and 322 of first and second collet arms 314 and 316.
As outer tube 330 is moved from first tube position P1 to second
tube position P2, collet closer 338 is moved over force application
end portions 320 and 322. Collet closer 338 includes inner tapered
surfaces 350, such that inner tapered surfaces 350 applies
compressive force to force application end portions 320 and 322
together as collet closer 338 is moved over force application end
portions 320 and 322, thus closing gap 318 therebetween.
[0103] In use, trigger 334 is actuated from first trigger position
TR1 to second trigger position TR2. Actuation of trigger 334 slides
outer tube 330 along collet holder 208 from first tube position P1
to second tube position P2, moving collet closer 338 along force
application end portions 320 and 322 of first and second collet
arms 314 and 316. Inner tapered surfaces 350 of collet closer 330
apply compressive forces to first and second force application end
portions 320 and 320, closing gap 318 and reducing bushing aperture
324 therebetween. Trigger 334 is released, allowing tube bias
member 344 to bias outer tube 330 from second tube position P2 to
first tube position P1, moving collet closer 338 away from force
application end portions 320 and 322.
[0104] Collet aperture 324 is configured to receive a cable 110/132
as described herein. In general, collet aperture 324 can be
configured to receive any fastener body. Examples of alternative
collet aperture configurations may be found U.S. patent application
Ser. No. 11/358,331, contents of which are hereby incorporated by
reference
[0105] Referring to FIGS. 30-31, crimping mechanism 206 can, in
accordance with the invention, further include a cutting mechanism.
In one embodiment, a cutting mechanism includes a pair of cut off
cams 352 positioned in collet gap 318. Cut of cams 352 each include
pin hole 351 such that a pin is inserted through collet 310 and
each of cut of cams 352, pivotally connecting cut off cams 352 to
collet 310. Cut off cams 352 each include cutting edges 353 for
cutting cable. A pair of wedges 354 are slidingly positioned along
and on opposite sides of collet 310 and collet holder 208. Each of
wedges 354 include tapered ends 356 positioned proximal to cut off
cams 352, such that when wedges are moved from first wedge position
W1 to second wedge position W2, tapered ends 356 compress cut off
cams 350 together, cutting cable 132. Biasing member 355 is
positioned about the end of cut-off cams 357, biasing cutting edges
353 in an open position. End portions 357 can include notched,
section 359 for retaining biasing member 355 thereon. Biasing
member 355 can be a circular nitinol spring, however any elastic
member will due.
[0106] With reference to FIG. 33, handle 202 further includes wedge
pusher 358 slidingly positioned about collet holder 208, adjacent
to second ends of wedges 354. Wedge pusher 358 is slidable from a
first position to a second position, such that wedges 354 are moved
from a first wedge position W1 to a second wedge position W2.
[0107] Rocker 360 is pivotally connected to handle 202, such that
an actuation of rocker 360 from first rocker position R1 to second
rocker position R2, slides wedge pusher 358 from first position to
second position, moving wedges 354 from first wedge position W1 to
second wedge position W2.
[0108] Referring to FIGS. 32-34, locking mechanism 370 includes
rocker kicker 372 pivotally affixed therein. Rocker kicker 372 is
biasedly connected to locking mechanism 370, being held in a closed
position by pin 374. When trigger 334 is actuated from first
trigger position TR1 to second trigger position TR2, release 376
engages pin 374, releasing rocker kicker 372.
[0109] When trigger 334 is released, trigger 334 is allowed to move
from second trigger position TR2 to first trigger position TR1. To
actuate cutting cams 352, trigger 334 is again moved from first
trigger position TR1 to second trigger position TR2, such that
rocker kicker 372 engages rocker 360, pivoting rocker 360 from
first rocker position R1 to second rocker position R2. Rocker 360
slides wedge pusher 358 from first position to second position,
moving wedges 354 from first wedge position W1 to second wedge
position W2, such that, tapered ends 356 urge cut off cams 352
together, whereupon a cable 132 may be cut. Trigger 334 can then be
released, releasing the crimped fastener 100.
[0110] Referring to FIG. 35, a cutting mechanism in accordance with
an embodiment of the invention further includes a stroke limiter to
prevent overdriving of the cut of cams 352. The stroke limiter
includes set screw 380 threadably positioned in threaded hole 382
through lower portion of rocker 360, set screw 380 is positioned
such that back end of set screw 380 extends from rocker 360. When
rocker 360 is actuated, the back end 384 of set screw contacts
contacting surface 386 in handle 20, thus limiting travel of rocker
360 and wedges 354, to thereby limit compression of cutting edges
353. Set screw 380 can be adjusted to adjust maximal compression of
cutting edges 353, thereby prevent overdriving of cut off cams
352.
[0111] In a method of use in accordance with the invention, cable
132 is passed through bone 104 and fracture 102, where first
fastener 112a secures cable 132 on first side (fracture side) of
bone and second fastener 112b is positioned about cable on second
side of bone, opposite first fastener 112a. Bushing 146 is
positioned onto cable 132 to secure second fastener 112a against
second side of bone 104.
[0112] Cable 132 is inserted through medical device 200 along
central longitudinal axis "A-A", through collet 310, collet holder
208, and cable tensioner 216, positioning bushing in bushing
aperture 324 and extending cable through cable aperture 222. To
tension cable, winding knob 270 is rotated until desired tension is
reached. Prior to use, desired tension can be set by rotating thumb
cap 300 to a tension indicated on cover plate 297.
[0113] Trigger 334 is actuated from first trigger position TR1 to
second trigger position TR2. Actuation of trigger 334 slides outer
tube 330 along collet holder 208 from first tube position P1 to
second tube position P2, moving collet closer 338 about force
application end portions 320 and 322 of first and second collet
arms 314 and 316. Inner tapered surfaces 356 of collet closer 338
apply compressive forces to first and second force application end
portions 320 and 322, compressing first and second force
application end portions 320 and 322 about bushing 146 positioned
in bushing aperture 324. Compressive forces crimp bushing about
cable 132, securing bushing 146 to cable 132.
[0114] Simultaneously, actuation of trigger 334 results in rocker
360 engaging wedge pusher 358, sliding wedge pusher 358 and wedges
354 along collet holder 208. Tapered ends 356 of wedges 354 engage
cut off cams 352, forcing cutting edge 353 into cable 132, cutting
cable 132.
[0115] The components of the medical device 200 of the present
invention are rigid members made of, for example, aluminum,
stainless steel, polymeric, composite materials, or combinations
thereof. The components are sufficiently rigid to transmit the
necessary forces. It should be understood that any material of
sufficient rigidity might be used. For example, some components can
be made by injection molding. Generally, for injection molding,
tool and die metal molds of the components am prepared. Hot, melted
plastic material is injected into the molds. The plastic is allowed
to cool, forming components. The components are removed from the
molds and assembled.
[0116] Furthermore, it is contemplated that the components can be
made of polymeric or composite materials such that the device can
be disposable. For example, at least some or all of the components
can be made of a biodegradable material such as a biodegradable
polymer. Among the important properties of these polymers are their
tendency to depolymerize relatively easily and their ability to
form environmentally benign byproducts when degraded or
depolymerized. One such biodegradable material is poly
(hydroxyacids) ("PHA's") such as polyactic acid ("PLA") and
polyglycolic acid ("PGA").
[0117] Additionally, the device can be made of a nonmagnetic
material. In such an instance, the device can be used as a
positioning device for use in imaging devices, such as an MRI
device. It is also contemplated that the system and medical device
of the present invention may be disposable or may be sterilized
after use and reused.
[0118] The methods and devices of the present invention may be used
in conjunction with any surgical procedure of the body. The repair,
reconstruction, augmentation, and securing of tissue or an implant
may be performed in connection with surgery of a joint, bone,
muscle, ligament, tendon, cartilage, capsule, organ, skin, nerve,
vessel, or other body part. For example, tissue may be repaired,
reconstructed, augmented, and secured following intervertebral disc
surgery, knee surgery, hip surgery, organ transplant surgery,
bariatric surgery, spinal surgery, anterior cruciate ligament (ACL)
surgery, tendon-ligament surgery, rotator cuff surgery, capsule
repair surgery, fractured bone surgery, pelvic fracture surgery,
avulsion fragment surgery, hernia repair surgery, and surgery of an
intrasubstance ligament tear, annulus fibrosis, fascia lata, flexor
tendons, etc. In one particular application, an anastomosis is
performed over a balloon and the methods and devices of the present
invention are used to repair the vessel.
[0119] Also, tissue may be repaired after an implant has been
inserted within the body. Such implant insertion procedures
include, but are not limited to, partial or total knee replacement
surgery, hip replacement surgery, bone fixation surgery, etc. The
implant may be an organ, partial organ grafts, tissue graft
material (autogenic, allogenic, xenogenic, or synthetic), collagen,
a malleable implant like a sponge, mesh, bag/sac/pouch, collagen,
or gelatin, or a rigid implant made of metal, polymer, composite,
or ceramic. Other implants include biodegradable plates, porcine or
bovine patches, metallic fasteners, compliant bearings for one or
more compartments of the knee, nucleus pulposus prosthetic, stent,
tissue graft, tissue scaffold, biodegradable collagen scaffold, and
polymeric or other biocompatible scaffold. The scaffold may include
fetal cells, stem cells, embryonal cells, enzymes, and
proteins.
[0120] The present invention further provides flexible and rigid
fixation of tissue. Both rigid and flexible fixation of tissue
and/or an implant provides compression to enhance the healing
process of the tissue. A fractured bone, for example, requires the
bone to be realigned and rigidly stabilized over a period time for
proper healing. Also, bones may be flexibly secured to provide
flexible stabilization between two or more bones. Soft tissue, like
muscles, ligaments, tendons, skin, etc., may be flexibly or rigidly
fastened for proper healing. Flexible fixation and compression of
tissue may function as a temporary strut to allow motion as the
tissue heals. Furthermore, joints which include hard and soft
tissue may require both rigid and flexible fixation to enhance
healing and stabilize the range of motion of the joint. Flexible
fixation and compression of tissue near a joint may provide motion
in one or more desired planes. The fasteners described herein and
incorporated by reference provide for both rigid and flexible
fixation.
[0121] It is contemplated that the devices and methods of the
present invention be applied using minimally invasive incisions and
techniques to preserve muscles, tendons, ligaments, bones, nerves,
and blood vessels. A small incision(s) may be made adjacent the
damaged tissue area to be repaired, and a tube, delivery catheter,
sheath, cannula, or expandable cannula may be used to perform the
methods of the present invention. U.S. Pat. No. 5,320,611 entitled,
Expandable Cannula Having Longitudinal Wire and Method of Use,
discloses cannulas for surgical and medical use expandable along
their entire lengths. The cannulas are inserted through tissue when
in an unexpanded condition and with a small diameter. The cannulas
are then expanded radially outwardly to give a full-size instrument
passage. Expansion of the cannulas occurs against the viscoelastic
resistance of the surrounding tissue. The expandable cannulas do
not require a full depth incision, or at most require only a
needle-size entrance opening.
[0122] Also, U.S. Pat. Nos. 5,674,240; 5,961,499; and 6,338,730
disclose cannulas for surgical and medical use expandable along
their entire lengths. The cannula has a pointed end portion and
includes wires having cores which are enclosed by jackets. The
jackets are integrally formed as one piece with a sheath of the
cannula. The cannula may be expanded by inserting members or by
fluid pressure. The cannula is advantageously utilized to expand a
vessel, such as a blood vessel. An expandable chamber may be
provided at the distal end of the cannula. The above mentioned
patents are hereby incorporated by reference.
[0123] In addition to using a cannula with the methods of the
present invention, an introducer may be utilized to position
fasteners at a specific location within the body. U.S. Pat. No.
5,948,002 entitled Apparatus and Method for Use in Positioning a
Suture Anchor, discloses devices for controlling the placement
depth of a fastener. Also, U.S. patent application Ser. No.
10/102,413 discloses methods of securing body tissue with a robotic
mechanism. The above-mentioned patent and application are hereby
incorporated by reference. Another introducer or cannula which may
be used with the present invention is the VERSASTEP.RTM. System by
TYCO.RTM. Healthcare.
[0124] The present invention may also be utilized with minimally
invasive surgery techniques disclosed in U.S. patent application
Ser. No. 10/191,751 and U.S. Pat. Nos. 6,702,821 and 6,770,078.
These patent documents disclose, inter alia, apparatus and methods
for minimally invasive joint replacement. The femoral, tibial,
and/or patellar components of a knee replacement may be fastened or
locked to each other and to adjacent tissue using fasteners
disclosed herein and incorporated by reference. Furthermore, the
methods and devices of the present invention may be utilized for
repairing, reconstructing, augmenting, and securing tissue or
implants during and "on the way out" of a knee replacement
procedure. For example, the anterior cruciate ligament and other
ligaments may be repaired or reconstructed; quadriceps mechanisms
and other muscles may be repaired. The patent documents mentioned
above are hereby incorporated by reference.
[0125] In addition, intramedullary fracture fixation and comminuted
fracture fixation may be achieved with the devices and methods of
the present invention. For example, a plate or rod may be
positioned within or against the fractured bone. A fastener may be
driven through or about the bone and locked onto the plate, rod, or
another fastener.
[0126] It is further contemplated that the present invention may be
used in conjunction with the devices and methods disclosed in U.S.
Pat. No. 5,329,846 entitled, Tissue Press and System, and U.S. Pat.
No. 5,269,785 entitled, Apparatus and Method for Tissue Removal.
For example, an implant secured within the body using the present
invention may include tissue harvested, configured, and implanted
as described in the patents. The above-mentioned patents are hereby
incorporated by reference.
[0127] Furthermore, it is contemplated that the methods of the
present invention may be performed under indirect visualization,
such as endoscopic guidance, computer assisted navigation, magnetic
resonance imaging. CT scan, ultrasound, fluoroscopy, X-ray, or
other suitable visualization technique. The implants, fasteners,
fastener assemblies, and sutures of the present invention may
include a radiopaque material for enhancing indirect visualization.
The use of these visualization means along with minimally invasive
surgery techniques permits physicians to accurately and rapidly
repair, reconstruct, augment, and secure tissue or an implant
within the body. U.S. Pat. Nos. 5,329,924; 5,349,956; and 5,542,423
disclose apparatus and methods for use in medical imaging. Also,
the present invention may be performed using robotics, such as
haptic arms or similar apparatus. The above-mentioned patents are
hereby incorporated by reference.
[0128] All references cited herein are expressly incorporated by
reference in their entirety.
[0129] It will be appreciated by persons skilled in the art that
the present invention is not limited to what has been particularly
shown and described herein above. In addition, unless mention was
made above to the contrary, it should be noted that all of the
accompanying drawings are not to scale. A variety of modifications
and variations are possible in light of the above teachings without
departing from the scope and spirit of the invention. Therefore, it
will be understood that the appended claims are intended to cover
all such modifications and embodiments which come within the spirit
and scope of the present invention.
* * * * *