U.S. patent application number 10/861865 was filed with the patent office on 2005-04-14 for minimally invasive bone manipulation device and method of use.
Invention is credited to Bhatnagar, Mohit, Cripe, Robert A., Jones, Scott A., Major, Eric D., Mathur, Sanjog Kumar, Woods, Richard W..
Application Number | 20050080425 10/861865 |
Document ID | / |
Family ID | 29553329 |
Filed Date | 2005-04-14 |
United States Patent
Application |
20050080425 |
Kind Code |
A1 |
Bhatnagar, Mohit ; et
al. |
April 14, 2005 |
Minimally invasive bone manipulation device and method of use
Abstract
A novel surgical apparatus for use in orthopedic surgery
procedures and a method for use is provided. The present invention
includes a protective sheath which prevents fouling of the moving
parts of the device by unwanted contact with surround tissue and
bone. The device relates primarily to the treatment of traumatic,
pathogenic, or osteoporotic bone conditions of human and other
animal body systems and, more particularly, to a novel apparatus
and method for manipulating the vertebral body through a less
invasive, percutaneous, surgical approach.
Inventors: |
Bhatnagar, Mohit; (Potomac,
MD) ; Major, Eric D.; (Ashburn, VA) ; Woods,
Richard W.; (Catonsville, MD) ; Jones, Scott A.;
(McMurray, PA) ; Cripe, Robert A.; (Costa Mesa,
CA) ; Mathur, Sanjog Kumar; (Columbia, MD) |
Correspondence
Address: |
Supervisor, Patent Prosecution Services
PIPER RUDNICK LLP
1200 Nineteenth Street, N.W.
Washington
DC
20036-2412
US
|
Family ID: |
29553329 |
Appl. No.: |
10/861865 |
Filed: |
June 7, 2004 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10861865 |
Jun 7, 2004 |
|
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10389818 |
Mar 18, 2003 |
|
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60365026 |
Mar 18, 2002 |
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Current U.S.
Class: |
606/90 |
Current CPC
Class: |
A61B 17/025 20130101;
A61B 17/00234 20130101; A61B 17/0218 20130101; A61B 2017/0256
20130101; A61B 17/0206 20130101; A61B 17/8858 20130101; A61B 17/02
20130101 |
Class at
Publication: |
606/090 |
International
Class: |
A61B 017/56 |
Claims
What is claimed is:
1. A surgical apparatus for use in manipulating tissue of a
subject, comprising: an elongated shaft assembly having a proximal
end and a distal end, said elongated shaft comprising an actuating
arm and an outer sleeve, said outer sleeve slidably circumscribing
at least a portion of said actuating arm, a handle assembly
attached to said proximal end of said shaft assembly, said handle
member being attached to said shaft assembly and configured such
that actuation of said handle assembly is capable of effecting
movement of actuating arm within said outer sleeve, and a spreading
assembly attached to said distal end of said shaft assembly, said
spreading assembly comprising at least one bracing member and at
least one extending arm and being at least partially surrounded by
a protective sheath, said bracing member having a first end and a
second end, said first end being rotationally attached to said
actuating arm and said second end being rotationally attached to
said extending arm, such that upon movement of said actuating arm,
said bracing member is capable of radially displacing at least a
portion of said extending arm, wherein said radially displaced
extending arm when displaced is capable of contacting and
manipulating said tissue.
2. The surgical apparatus of claim 1, wherein said tissue is within
the vertebral body of said subject.
3. The surgical apparatus of claim 1, further comprising a base
plate attached to said extending arm.
4. The surgical apparatus of claim 3, wherein said extending arm
has a proximally disposed arm first end and a distally disposed arm
second end, said base plate being attached at said arm second
end.
5. The surgical apparatus of claim 4, wherein said base plate is
rotationally attached to said extending arm.
6. The surgical apparatus of claim 1, wherein said spreading
assembly is releasably attached to said shaft assembly such that
when said spreading assembly is selectively released from said
shaft assembly, said sheath remains in place with said spreading
assembly.
7. The surgical apparatus of claim 5, wherein said spreading
assembly can be locked in a position such that said base plate is
radially displaced from said shaft assembly.
8. The surgical apparatus of claim 1, wherein said bracing member
is manufactured of rigid material.
9. The surgical apparatus of claim 1, wherein said handle assembly
comprises a first handle member and a second handle member.
10. The surgical apparatus of claim 9, wherein said handle assembly
further comprises a biasing member, said biasing member being
configured to keep said first handle member apart from said second
handle member.
11. The surgical apparatus of claim 9, wherein said handle assembly
further comprises a controlled compression assembly, which is
capable of fine-tuned control of the compression of the two handle
members.
12. The surgical apparatus of claim 9, wherein said first handle
member comprises a actuating arm anchor, said actuating arm being
movably connected to said arm anchor.
13. The surgical apparatus of claim 12, wherein said second handle
member comprises an actuating arm portal, said arm portal being
connected to said outer sleeve; such that when said first handle
member and said second handle member are moved in relation one to
the other, said actuating arm slidably moved within said outer
sleeve through said actuating arm portal.
14. The surgical apparatus of claim 1, wherein said spreading
assembly comprises multiple extending arms and multiple bracing
members.
15. The surgical apparatus of claim 14, wherein said extending arms
are rotationally connected to a base plate.
16. The surgical apparatus of claim 15, wherein said base plate has
two extending arms rotationally connected thereto at a single
rotation point.
17. The surgical apparatus of claim 15, wherein said base plate has
two extending arms rotationally connected at separate respective
rotation points.
18. The surgical apparatus of claim 14, wherein said extending arms
and said bracing members are aligned one to another in a
scissor-jack configuration.
19. The apparatus of claim 1, wherein at least two of the following
are releasably connected one to the other, said shaft assembly,
said handle assembly and said spreading assembly.
20. The apparatus of claim 1, wherein said handle assembly is a
knob-type assembly.
21. The apparatus of claim 1, wherein said handle assembly further
comprises a handle position lock.
22. The apparatus of claim 1, wherein at least a portion of said
device is radiopaque.
23. The apparatus of claim 1, wherein said sleeve is so configured
as to be capable of acting as a conduit for bone cement being
injected into a space formed by said spreading assembly after
removal of said actuating arm from said sleeve.
24. A method of forming a space within a vertebral body of a
subject, the method comprising: providing an apparatus according to
claim 1, inserting said apparatus into the vertebral body of said
subject, actuating the handle assembly so as to cause the spreading
assembly to open and contact the interior bone material of the
vertebral body, whereby said vertebral body has a space formed.
25. The method of claim 24, wherein said inserting step is
accomplished using minimally invasive surgical technique.
26. The method of claim 24, where said spreader assembly of said
apparatus according to claim 1 is disconnected and left within said
vertebral body after said space is formed.
27. The method of claim 24, wherein said spreading assembly is
removed from said vertebral body after said space is formed.
28. The method of claim 26, further comprising the step of filling
said space formed with supporting material.
29. The method of claim 27, further comprising the step of filling
said space formed with supporting material.
Description
[0001] This application is a Continuation-in-Part of U.S.
application Ser. No. 10/389,818, filed Mar. 18, 2003 which claims
priority to U.S. Provisional Application Serial No. 60/365,026
filed Mar. 18, 2002. The entirety of which are incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] This invention relates to a novel surgical apparatus for use
in orthopedic surgery procedures. Particularly, the present
invention relates to the treatment of traumatic, pathogenic, or
osteoporotic bone conditions of human and other animal body systems
and, more particularly, to a novel apparatus and method for
manipulating the vertebral body through a less invasive,
percutaneous, surgical approach.
[0004] 2. Background of the Technology
[0005] Surgical procedures frequently require that after surgical
entry has been made the tissues within the patient's body must be
expanded away from the surgical point of interest in order to
provide better access and visibility for the surgeon. Various
surgical devices have been developed to assist the surgeon to
displace tissue and expand the interior cavities of the body during
both open surgical procedures and less invasive surgical
procedures.
[0006] Surgical procedures vary dramatically depending upon the
region of the body involved and the purpose of the surgery. The
design and the use of surgical instruments are equally specialized
and instruments which seemingly are intended for similar purposes
can be significantly different from one another depending upon the
exact nature of the surgery. The use of retractors to expand an
opening or create a space to facilitate access for the surgeon
during the performance of a surgical procedure is well known in the
art. It is, however, often the case that one tissue retractor
designed for use in a particular surgical procedure will be
completely unsuitable for retraction of tissue in a different type
of surgery.
[0007] Conventional surgical procedures, which have been employed
to alleviate vertebral compression failures, involve major invasive
surgical techniques with all of the possible negative consequences.
The close proximity of the spinal cord to damaged sections of a
vertebra, which are in need of surgical repair, presents a
particularly hazardous situation for the patient and increases the
challenge for the surgeon tremendously. Recent surgical innovations
have been made that provide a means of reinforcing damaged vertebra
by the injection of bone cement into the vertebral body. However,
in patients suffering from crippling effects of osteoporosis and
the possibility of compression fractures of multiple vertebra,
there remains a need for an effective and safe way to distract the
vertebral endplates so as to alleviate the compressed disposition
of the vertebral body. Such a specialized requirement dictates the
need for a specialized tissue expansion device. Numerous tissue
expansion devices have been developed for different surgical
procedures but at present none are suitable or capable of
adaptation so as to safely manipulate the endplates of a patient's
vertebra.
[0008] U.S. Pat. No. 6,309,349 issued to Bertolero et al. discloses
a typical tissue retractor used to expand a body wall entry
incision. For nearly a century such retractors with one or more
specialized modifications have been used to meet the particular
requirements for body wall incision expansion in different surgical
procedures. Examples of other retractor-type tissue manipulators or
expanders are disclosed in U.S. Pat. No. 6,354,994 issued to Rullo
et al. and U.S. Pat. No. 6,322,500 issued to Sikora et al.
Retractors representative of this type are commonly used for open
surgical procedures and would be unsuited to less invasive surgical
procedures such as, for example, endoscopic surgery.
[0009] U.S. Pat. No. 6,319,252 issued to McDevitt et al. discloses
an apparatus designed to attach a patient's soft tissue to bone
material. The design of the apparatus permits the user to
manipulate an expander pin through soft tissue and into a position
in the bone to which the tissue is to be anchored. A screw-type
expander mechanism allows the diameter of the circumferentially
disposed expander pin to be increased so as to press into the
surrounding bone. A small portion of bone is equilaterally
displaced around the circumference of the expander pin. A very
similar device designed for a slightly different surgical procedure
is disclosed in U.S. Pat. No. 6,221,107 issued to Steiner et al.
The device of Steiner et al. also employs a screw-type expander
provided with special features, which facilitate the attachment of
the ligament of a patient to a passage or channel created in a bone
by the surgeon. Such devices have vary specialized uses and are
incapable of selectively directing the expansion of the surrounding
tissue. Further with a screw-type expander the amount of expansion
of the surrounding tissue is very limited; as such this type of
expansion device is typically suited only for anchoring the device
into the surrounding tissue.
[0010] U.S. Pat. No. 5,888,196 issued to Bonutti discloses a
mechanically expandable retractor for use in arthroscopic surgery.
This surgical device is a dual sleeve-type expander, which is
designed for creating a void in subsurface tissues using
arthroscopic surgical procedures. This type of device is designed
for movement of tissue in the repair of carpal tunnel syndrome. The
dual sleeve expansion device of Bonutti can be configured to have
one or more expandable portions of the flexible outer sleeve
located near the tip of the device. The jointed expandable portions
present an acute outermost contact surface that could easily damage
tissue with which it comes in contact and further would provide a
limited point of expansion rather than a uniform area of expansion.
While the expanding sleeve of Bonutti provides an expansion device
that can be used in less invasive surgical procedures such as
treatments for carpal tunnel syndrome, it would be wholly unsuited
for safe use in the manipulation of bone, particularly when
employed within a vertebral body, where the point-oriented
expansion device might seriously damage already weakened bone. U.S.
Pat. No. 6,139,508 issued to Simpson et al. discloses a similar
sleeve expansion device for displacing tissue in the vicinity of a
biopsy site. The sleeve expansion design devices have limited and
specialized use for the temporary dislocation of soft tissue in the
vicinity of a surgical site or a biopsy site. WO 02/13700 A2
discloses a flexible sleeve expansion device having a deformable
flexible distal portion of the sleeve for use in treatment of the
spine. This device, much like balloon technology relies upon the
radial displacement of a soft flexible sleeve, however, it does not
have the benefit of the compressed air or fluid that provides a
more consistent outward force in balloon type devices.
[0011] U.S. Pat. No. 6,358,266 issued to Bonutti discloses an
active cannula or sleeve, which can be used to enlarge a channel so
as to enable the positioning of a scope or instrument or to move or
relocate tissue. Bonutti '266 employs an inflatable balloon as the
mechanical device to expand the skin around a surgical entry site.
The application of balloon technology as a tissue expander has also
been employed in U.S. Pat. No. 6,241,734 issued to Scribner et al.,
which teaches the use of a balloon expansion device employed within
a vertebra for the purpose of creating a space with the tissue. The
Scribner et al. device, like other balloon-type expansion devices
are uncontrolled and multi-directional, which can lead to
undesirable expansion of the bone or bone fragments being displaced
in unwanted directions.
[0012] Conventionally used tissue expansion devices are each
configured to precisely meet the specific needs for particular
surgical procedures and, as such, are not readily (if at all)
adaptable to meet the needs of a different surgical procedure.
[0013] In addition to the deficiencies of the conventionally used
mechanical expansion devices discussed above, each such device
shares the common problem of possibly suffering mechanical
interference or fouling of the mechanism when tissue or bone come
into contact with the internal mechanism of the devices. Such
fouling of the mechanism by involvement with tissue or bone during
the insertion process, expansion process, or the retraction process
can severely limit the effectiveness of such a device. Each
possibility presents a unique problem for the surgeon using an
unprotected manipulating device, such as, for example, if the
mechanism becomes fouled or occluded during the insertion process,
it may fail to operate once it is properly in place. Similarly, it
is possible that during operation of the expansion mechanism, the
exposed mechanism can become occluded and thus limit or fully stop
the expansion process. Finally, if the unprotected mechanism is
fouled or hung-up on tissue or bone during the retraction or
removal process, the removal may be impeded so as to require
additional surgical procedures to successfully extract the
device.
[0014] There is therefore a need for a less invasive surgical
device, which can be precisely controlled by the surgeon to expand
tissue and transmit sufficient force to manipulate bone in a
selected direction or, if desired, in multiple directions. Further,
the need exists for such a device to have protection of the
mechanism from unwanted contact with surrounding tissues, where
such contact might result in occlusion or fouling of the mechanism
such that the function of the device is compromised. None of the
tissue expansion devices currently used to assist a surgeon in
creating a void in tissue can fulfill this requirement.
SUMMARY OF THE INVENTION
[0015] The present invention provides a device and method, which
can be used by a surgeon to meet the above identified need for
specialized surgical procedures. In particular, the device of the
present invention is designed for use as a less invasive means of
controllably manipulating a damaged bone, and in particular a
patient's vertebra to create a void therein so as to enable a
surgeon to accomplish a surgical procedure while providing a
protective member on the mechanism to avoid undesirable contact
with surrounding tissue and bone.
[0016] It is therefore an object of the present invention to
provide a tissue expansion device, which can be used in open or
minimally invasive surgical procedures to selectively, in a
measured manner, directionally expand tissue to create a void
within a tissue mass, particularly within the interior of the bone,
all the while having the mechanism of the device protected from
contact with surrounding tissue and bone so as to ensure smooth
unimpeded operation.
[0017] It is a further object of the present invention to provide a
tissue expansion device that is capable of endoscopic or
arthroscopic use by a surgeon to controllably create with
specificity a void within the vertebral body of a subject's
vertebra.
[0018] It is another object of the present invention to provide a
tissue expansion device that is capable of selectively exerting
sufficient force in one or more directions to manipulate a tissue
mass, particularly bone tissue.
[0019] Another object of the present invention is to provide a
tissue expansion device that is capable of the controlled, measured
and predictable distracting of the vertebral endplates of a
patient's vertebra from within the vertebral body.
[0020] Another object of the present invention is to provide a
tissue expansion device, which incorporates a selectively
releaseable spreading assembly or modular expansion member for
correcting the positioning of tissue or bone. After the tissue or
bone correction has been effected the spreading assembly can be
released and left implanted in the patient to maintain the
correction.
[0021] Another object of the present invention is to provide a
method for forming a space within tissue while employing a
minimally invasive surgical procedure.
[0022] Another object of the present invention is to provide a
method for manipulating bone tissue in a directionally controlled
and measured manner.
[0023] Another object of the present invention is to provide a
method for distracting the vertebral endplates of a patient's
vertebra from with the vertebral body.
[0024] Another object of the present invention is to provide a
method for correcting the positioning of tissue or bone with a
patient and implanting a spreading assembly into the patient to
maintain the tissue position correction.
[0025] Another object of the present invention is to provide a
method for providing additional long term support for the vertebral
body by inserting supporting material, such as bone cement or the
like, into the space formed by the device of the present invention.
This object can be achieved after the device of the present
invention has been used to create a space within the veterbral body
and the spreading assembly has been removed. Alternatively, this
object can be achieved by inserting the bone cement into the space
within the vertebral body after the spreading assembly has been
selectively detached from the shaft assembly of the device. In this
embodiment, the spreading assembly is left in place within the
vertebral body so as to provide additional support along with the
bone cement for the vertebra. In every case, the sleeve portion of
the present invention can serve as a conduit for introduction of
the bone cement.
[0026] All of these objects are achieved by the use of the device
and method of the present invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0027] The invention will now be described, by way of illustration
only, with reference to the accompanying drawings.
[0028] FIG. 1 is a cross-sectional plan view of a first embodiment
of the device of the present invention, which shows the mechanism
configured in an expanded position.
[0029] FIG. 2 is a cross-sectional plan view of a first embodiment
of the device of the present invention, which shows the mechanism
configured in a closed position.
[0030] FIG. 3 is an isometric view of the mechanical detail of the
modular spreading assembly of a second embodiment of the present
invention in the expanded position.
[0031] FIG. 4 is an isometric view of the mechanical detail of the
modular spreading assembly of the embodiment of the present
invention of FIG. 3 shown in the closed position.
[0032] FIGS. 5A-C show plan, top and end views of the modular
spreading assembly of the embodiment of the present invention shown
in FIGS. 3-4.
[0033] FIG. 6 is an isometric view of an alternative handle
assembly of the present invention.
[0034] FIGS. 7A-B show a side and end view of a third embodiment of
the device of the present invention in a closed (A) and open (B)
position.
[0035] FIGS. 8A-B show a side and end view of a fourth embodiment
of the device of the present invention in a closed (A) and open (B)
position.
[0036] FIG. 9 shows a protective sheath enclosing another
alternative embodiment of the spreading assembly of the present
invention.
[0037] FIG. 10 shows another alternative embodiment of the handle
assembly of the present invention.
[0038] FIGS. 11A-11C show three non-limiting, alternative examples
of a knob-type handle assembly for use with the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0039] The apparatus and method of the present invention can be
adapted for use in a variety of surgical procedures which require
precise tissue manipulation by a surgeon. The following description
and associated FIGS. 1-11C are provided as non-limiting examples of
the invention, which is defined with particularity only by the
claims of the present invention.
[0040] As shown in FIGS. 1-10, a tissue manipulation device (10) is
provided. A preferred embodiment of the present invention is
configured to be particularly well-suited to the manipulation of
bone in a subject. By way of example, the device (10), as best
shown in FIGS. 1-9, includes three portions or assemblies which can
be integrally formed or separately fabricated prior to being joined
to form the device (10).
[0041] The three assemblies, which together form the device (10),
include a handle assembly (12), a shaft assembly (14) and a
spreading assembly (16). A proximal end (18) of the shaft assembly
(14) is connected to the handle assembly (12) and a distal end (20)
of the shaft assembly (14) is connected to the spreader assembly
(16).
[0042] As earlier indicated, these three assemblies (12, 14, 16)
can be integrally formed or, alternatively, can be individually
formed and then connected to form the whole device (10). It is also
within the concept of the present invention for the one or more of
the assemblies to be releasably connected one to the other.
[0043] In an embodiment where the three assemblies (12, 14, 16) are
formed and subsequently permanently connected one to the other, the
connections may be of any character known for connecting parts of a
whole into one unit, to include, for example: gluing, soldering,
welding, mechanically joining by rivets or screws or the like or
any other means for permanently connecting parts one to the
other.
[0044] If the three assemblies (12, 14,16) are releasably attached
one to the other, any releasable attachment means known can be
used, to include, for example: snap fittings, bayonet fittings,
luer lock fittin0gs, threaded fittings, cotter-pin connections,
plug and socket connections, or any other releasable attachment
means. If the device (10) is integrally formed, any manufacturing
process known can be employed, to include extrusion molding,
die-casting, tooling, or any other means of fabricating such a
device.
[0045] When the device (10) is configured to permit releasable
attachment of the three assemblies (12, 14, 16) to each other, it
is possible for the user to attach alternative embodiments of any
of the three individual assemblies (12, 14, 16). This feature of
the invention permits each of the three assemblies (12, 14, 16) to
separately have specifically designed embodiments that are
configured for very specific uses or for individual preferences of
the using surgeon. Thus, one embodiment of the device (10) enables
the user to customize the combination of the three assemblies (12,
14, 16) to meet the particular requirements for a specific surgical
procedure.
[0046] As best shown in FIGS. 1-2, the handle assembly (12) can be
configured to operate as a scissor-like embodiment so as to provide
ease of handling by a user during operation of the device (10).
FIG. 1 provides a depiction of the scissor-like embodiment of the
handle assembly (12) in the device-open configuration while FIG. 2
depicts this embodiment in a device-closed configuration. It is
within the concept of the invention to reverse the operable effect
of the handle positions shown in FIGS. 1 and 2 without departing
from the concept of the invention. The scissor-like embodiment of
the handle assembly (12) depicted in FIGS. 1 and 2 can include a
first handle member (22) and a second handle member (24), each
handle member (22, 24) having respectively a connecting end (26,
28) and a gripping end (30, 32).
[0047] Each of the connecting ends (26, 28) are movably connected
one to the other by a handle member connector (34). In a preferred
embodiment, the handle member connector (34) is configured as a
handle member pivot pin (36) although the handle member connector
(34) can be configured as rotationally engaged portions of the
first and second handle members (22, 24). Thus, the handle member
connector (34) can be configured to include a pivot pin (36), a
rotating ball-and-socket joint, a rotating rim-and-groove joint, or
any other connection design which permits the connecting ends (26,
28) of the first and second handle members (22, 24) to be connected
in a moveable relationship one to the other. The first and second
handle members (22, 24) can be biased into a closed or open
relationship one to the other by a biasing member (38), which can
be releasably attached to facilitate repair and replacement.
[0048] The handle members (22,24) can define an actuating arm
portal (40) which provides for an arm anchor (42) defined within
the second handle member (24). The portion of the portal (40)
defined through the first handle member (24) can be sized and
configured to hold and restrict the movement of an actuating arm
sleeve (44). The shaft assembly (14) includes the actuating arm
sleeve (44) and the actuating arm (46). The actuating arm sleeve
(44) can be sized and configured to permit sliding passage of the
actuating arm (46). The actuating arm (46) at its proximal end (48)
can be releasable attached to the actuating arm anchor (42). Both
the actuating arm (46) and the actuating arm sleeve (44) are
configured to be in a sliding relationship, one within the other,
and to be of a respective fixed length such that the actuating arm
(46) can slide to a position which extends beyond the distal end
(50) of the sleeve (44).
[0049] Attached at the distal end of the actuating arm (52) is a
spreading assembly (16). The spreading assembly (16) can be sized
and configure to fit within the sleeve (44) when the actuating arm
(46) is fully withdrawn into the sleeve (44). The spreading
assembly (16) can be releasable from the actuating arm to permit
the surgeon to insert the spreading assembly into a bone, actuate
the spreading assembly into an expanded position, and, if desired,
disconnect the spreading assembly so as to permit it to be left
within the bone. This optional releasable feature of the spreading
assembly (16) also permits the device to be configured with
different sizes and configurations of spreading assembly prior to
use.
[0050] The spreading assembly (16), as best seen in FIGS. 3, 4, and
5A-C, can be configured to include at least one extending arm (56)
that can be in pivotal relationship at one end with the actuating
sleeve (44). Any sufficiently strong material compatible for use in
surgical instruments can be used in the manufacture of the device.
The extending arm (56) is preferably manufactured of a rigid
material to provide strength and reliable, consistent performance
during operation. Conventional spreaders, which can include
flexible sleeves are incapable of providing the even, consistent
force during operation that is essential for safely manipulating
bone material. This especially important when manipulating the end
plates of a vertebral body. At least one bracing member (58) is
rotationally attached at one end to the actuating arm (46) and
rotationally attached at the other end to the proximal end of the
extending arm (56). Due to the operational requirement of
manipulating bone, it is preferable that the bracing member be
manufactured of rigid material, however any material suitable for
use in surgical instruments can be used if sufficiently strong. In
operation, when the actuating arm (46) is extended distally beyond
the confines of the sleeve (44), the bracing member (58) serves to
exert a force on the extending arm (56) so as to force the
spreading assembly into an open position. A locking mechanism can
be provided so as to releasably lock the spreading assembly into
position. This locking mechanism can be configured as a notch,
slot, or other like means to fix the spreading assembly into an
open position. The locking mechanism can be selectively locked or
unlocked.
[0051] To facilitate smooth operation of the spreading assembly
(16), a guide bar (60) sized and configured to slidably move with
the confines of a guide slot (62) can be provided. The guide slot
(62) can define the forward most and reward most movement of the
guide bar (60) and in so doing control the degree of extension of
the spreading assembly in operation. The guide slot (62) can thus
be sized to control the amount of extension possible for the
spreading assembly (16). The distal most portion of the extending
arm (56) can be provided with a base plate (64), which can be
pivotally attached thereto. The base plate (64) is sized and
configured to provide a contact surface (66) that in operation is
brought into contact with the bone to be manipulated. This contact
surface (66) can provide a protective element to distribute the
pressure exerted by spreading assembly across a broader surface of
the bone being manipulated.
[0052] To provide visual feedback to the surgeon, the device (10)
can be manufactured such that at least a portion of the device is
radiopaque. It is within the concept of the invention that only
select portions of the device (10), such as, for example, the
contact surface (66) or the base plate (64) are manufactured or
treated to include radiopaque material. Any method known in the art
to manufacture or treat the device (10) so as to have a radiopaque
quality can be employed without departing from the general concept
of the present invention.
[0053] The first embodiment of the present invention described
above illustrates the concept of the invention. It is, however,
within the scope of the invention to configure the device (10) with
a wide variety of handle assemblies (12) that would serve to
actuate the device by movement of the actuating arm (46) with the
actuating arm sleeve (44). Another non-limiting example of an
alternative handle assembly (12) is shown in FIG. 6. This
alternative handle assembly (12) can be configured similar to the
scissor-like embodiment shown in FIGS. 1-2 with the additional
feature of a handle locking assembly, generally shown at (68). The
handle locking assembly (68) can be provided with a locking catch
(70) similar to that typically found on a hemostat instrument. The
locking catch (70) can be employed with a handle locking arm (72)
that is configured for releasably locking the handle assembly (12)
to a desired open, partially open, or closed position as desired by
the using surgeon.
[0054] Another embodiment of the invention can include an
alternative handle assembly as shown in FIG. 10, which generally
includes the basic features of the handle assemblies discusses
above, that is, opposing first and second handle members (22, 23),
a handle member connector (34) and pivot pin (36), an actuating arm
anchor (42) for securing the distal end of the actuating arm (46),
and at least one biasing member (38). The alternative handle
assembly shown in FIG. 10 also includes the additional feature of a
grip stabilizing member (77), against which the users' first thumb
joint can rest during operation, and a controlled compression
assembly, generally shown at (78), which provides a means for the
user to fine-tune control the compression of the two handle
members. The controlled compression assembly (78) includes a
threaded compression shaft (79) that is rotatably connected to the
second handle member (23) by a shaft securing member(80). The
threaded compression shaft (79) slidably extends through a
compression shaft bore (81) defined in the first handle member 22
and terminates in a manual controller stop (82). The manual
controller stop (82) acts to limit the extreme movement of the
manual controller (83), which is correspondingly-threaded and
disposed around the threaded compression shaft (79). In a preferred
embodiment of this handle assembly, the manual controller (83) is
configured as a thumb wheel for ease of operation. In operation,
the user can manually compress the handle members (22, 23) together
and, if desired, move or thread the manual controller (83) along
the threaded compression shaft (79) to a position that holds the
two handle members (22, 23) in the selected position relative one
to the other. Alternatively, the handle members can be moved toward
or away from each other by simply manually turning the manual
controller (83) so as to tighten or loosen the control member
against the outward bias of the first handle member (22), the bias
being provided by the at least one biasing member (38).
[0055] Without departing from the general concept of the invention,
the handle assembly (12) can be provided as a simple grip and
control mechanism, such as a knob, in place of a multi-membered
squeeze-actuated handle. As best shown in FIGS. 11A-11C, This
alternative knob configuration can be provided as a simply
configured control knob (88), which can be provided in any form as
is known in the art, to include, for example a rotationally
attached, longitudinally aligned knurled knob (88) employing a
screw-type actuator (89) to advance or retract the actuating arm
(46) within the sleeve (44); the knob being knurled (90) or
equipped with one or more radially extending side grips (91), or
equipped with a circumferentially disposed gripping ring (92), as
is commonly used in the art, for example as a common handle for a
water faucet valve. Regardless of the configuration selected, the
knob (88) embodiment of the handle assembly provides for the user a
gripping element with a manual device actuator to selectively
expand or retract the spreading assembly (16) of the present
invention in much the same way as the other embodiments of the
handle assembly (12).
[0056] Each of the alternative handle assembly embodiments
discussed herein when manually operated by a user results in the
movement of the actuating arm (46) within the sleeve (44) such that
the spreading assembly (16) is expanded so as to manipulate
tissue.
[0057] As best shown in FIGS. 7A-B and 8A-B, additional alternative
embodiments of the present invention can be provided which employ
the same concept of the earlier described embodiment with the
modification of providing a dual-scissor assembly, generally shown
at (74), that permits the use of two bracing members (58) pivotally
attached to the actuating arm (46) at the proximal end and
pivotally attached at a base plate pivot point (76). In FIGS. 8A-B,
an alternative embodiment using two bracing members (58) attached
at a single base plate pivot point is shown in both the closed (A)
and open (B) positions. In FIGS. 7-A-B, the alternative embodiment
is shown using two bracing members (58) attached at two distinct
pivot points (alternative embodiments provide a configuration with
the potential for increased leverage strength during the opening of
the spreading assembly (16) as well as, in the case of FIGS. 7A-B,
a broader base of support for the base plate (64).
[0058] The present invention preferably includes a means of
protecting the mechanism of the spreading assembly (16) from
unwanted contact, entanglement, and interference with the tissue of
a subject. On ingress, during operation, and on egress from the
tissue-manipulation site within a subject, it is possible for
surrounding tissue or bone to become so involved with the internal
mechanism of the spreading assembly (16) that the device might be
operationally impaired or rendered inoperable altogether. As shown
in FIG. 9, the present invention provides a protective sheath (84)
constructed of a highly flexible, high memory material that tightly
and closely overlays the entirety of the spreading assembly (16) so
as to provide a protective layer capable of keeping all unwanted
tissue contact from the working mechanism of the spreading
assembly.
[0059] The sheath (84) can be constructed of any
medically/surgically acceptable elastic formulation that can be
easily stretched during full expansion of the spreading assembly
(16) without losing its integrity and without causing extreme
resistance to spreading and back pressure on the spreading
assembly. Further, the material used to fabricate the sheath (84)
will have extremely good memory, that is shape-recovery character,
and as the spreading assembly is returned to its compact,
non-spread configuration, the sheath will return to its tight,
close relationship to the more compact configuration of the
spreading assembly (16). Thus, the sheath (84) will upon spreading
of the spreading assembly (16) provide protection of the mechanism
and, upon return to the non-spread configuration the sheath (84)
will provide a smooth tight surface around the spreading assembly
so as to facilitate the easy passage of the spreading assembly from
the subject when the user chooses to retract the device. The sheath
(84) is preferably manufactured of a polyurethane material and will
be circumferentially bonded to the sleeve (44) of the device at a
bonding point (85) just before the spreading assembly (16) exit
from the sleeve (44). In either embodiment, the sheath (84) bonded
to the sleeve (44) or bonded to the actuating arm (46), the
mechanism of bonding can be by any secure and permanent means known
in the art to include, but not limited to using adhesives, heat
sealing, shrink film adhesion, or mechanical connection, such as,
for example a groove and circumferentially inserted securing ring
(86). Alternatively, the sheath (84) can be bonded to the spreading
assembly at a point just before the spreading mechanism of the
spreading assembly (16). For those embodiments of the present
invention, where the spreading assembly can be released from the
actuating arm and left within the subject as a structural support
for the bone that that has been manipulated, the device can be
configured to have a quick disconnect (87) point between the
actuating arm (46) and the spreading assembly (16). Such a quick
disconnnect can be provided by mechanical disconnect means,
manufacture of a programmed break-away or shear point for a given
torque, or any method of providing such a disconnection as is known
in the art. The sheath (84) for such an embodiment remains intact
and in place around the spreading assembly (16).
[0060] The alternative configuration of the spreading assembly (16)
shown in FIG. 9 is similar in design and assembly to that earlier
described in FIGS. 7A and 7B with the adjustment that the two
extending arms (56) and the two bracing members (58) cross over
each other respectively in a scissor-jack configuration. Each of
the ends of the extending arms (56) and bracing members (58)
terminate on two attachment points on the butt plate (64) in the
same manner as the spreading assembly (16) embodiment shown in
FIGS. 7A and 7B.
[0061] Each of the embodiments described above are provided for
illustrative purposes only and it is within the concept of the
present invention to include modifications and varying
configurations without departing from the scope of the invention
that is limited only by the claims included herewith.
* * * * *