U.S. patent application number 11/325775 was filed with the patent office on 2006-05-25 for device and method for determining parameters of blind voids.
Invention is credited to Lehmann K. Li.
Application Number | 20060111651 11/325775 |
Document ID | / |
Family ID | 26910082 |
Filed Date | 2006-05-25 |
United States Patent
Application |
20060111651 |
Kind Code |
A1 |
Li; Lehmann K. |
May 25, 2006 |
Device and method for determining parameters of blind voids
Abstract
Device for determining the size of a blind void comprises an
elongated rigid rod, an actuator slidably movable relative to the
rod, the actuator having a distal end for insertion into the void,
a distal flexible element fixed at one end thereof to the rod, a
second flexible element fixed at one end thereof to the rod and
proximally removed from the distal flexible element. Movement of
the actuator is operative to cause equal movements of the distal
end portions of the distal and proximal elements, to cause the
distal element to bulge outwardly from the rod to engage interior
walls of the void and to cause the proximal element to bulge
outwardly in a configuration duplicative of the distal element
bulge, the proximal element being outside of the void and subject
to observation.
Inventors: |
Li; Lehmann K.; (Milford,
CT) |
Correspondence
Address: |
WOODARD, EMHARDT, MORIARTY, MCNETT & HENRY LLP
111 MONUMENT CIRCLE
SUITE 3700
INDIANAPOLIS
IN
46204-5137
US
|
Family ID: |
26910082 |
Appl. No.: |
11/325775 |
Filed: |
January 5, 2006 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10827100 |
Apr 19, 2004 |
6983546 |
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11325775 |
Jan 5, 2006 |
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10330699 |
Dec 27, 2002 |
6723058 |
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10827100 |
Apr 19, 2004 |
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09894727 |
Jun 28, 2001 |
6500132 |
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10330699 |
Dec 27, 2002 |
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60215486 |
Jun 30, 2000 |
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Current U.S.
Class: |
600/594 |
Current CPC
Class: |
A61B 5/1076 20130101;
A61B 5/4514 20130101 |
Class at
Publication: |
600/594 |
International
Class: |
A61B 5/107 20060101
A61B005/107 |
Claims
1-22. (canceled)
23. An apparatus, comprising: a first element insertable within a
blind void and transitionable to a first configuration
corresponding to a parameter of the blind void; and a second
element coupled to said first element, said second element assuming
a second configuration in response to said first configuration of
said first element.
24. The device of claim 23, wherein at least one of said first and
second elements are at least partially formed of a flexible
material.
25. The device of claim 24, wherein said second element is at least
partially formed of a flexible material, and wherein said
configuration of said second element is defined by an outward
deformation of said flexible material.
26. The device of claim 24, wherein said first element is at least
partially formed of a flexible material, and wherein said
expandability of said first element includes outward deformation of
said flexible material.
27. The device of claim 24, wherein at least one of said first and
second elements comprises a pair of said flexible strips of
material arranged generally opposite one another.
28. The device of claim 23, wherein said first element is adapted
to engage an interior wall surrounding the blind void.
29. The device of claim 23, wherein said first element is adapted
to approach an interior wall surrounding the blind void.
30. The device of claim 23, wherein said first element has an
initial configuration adapted for insertion into the blind void in
a minimally invasive manner.
31. The device of claim 23, wherein said second configuration of
said second element is substantially identical to said first
configuration of said first element.
32. The device of claim 23, wherein said second configuration of
said second element is subject to direct visualization.
33. The device of claim 23, wherein said second configuration of
said second element is subject to at least one of electronic and
mechanical measurement.
34. The device of claim 23, further comprising an actuator coupled
to said first element, wherein actuation of said actuator expands
said firs element to at least approximate said parameter.
35. A method, comprising: providing an apparatus including a first
element adapted for insertion within a blind void and a second
element; inserting the first element into the blind void in a first
configuration; transitioning the first element to a second
configuration; and transitioning the second element to a third
configuration relating to the second configuration of the first
element.
36. The method of claim 35, wherein at least a portion of at least
one of the first and second elements is formed of a flexible
material; and wherein the transitioning of at least one of said
elements having flexible material comprises flexibly deforming the
flexible portion.
37. The method of claim 35, further comprising inserting the first
element into the blind void in a minimally invasive manner while in
the first configuration.
38. The method of claim 37, further comprising: transitioning the
first element back toward the first configuration; and removing the
first element from the blind void.
39. The method of claim 35, wherein the transitioning of the first
element to the first configuration comprises engaging the first
element against an interior wall of the blind void.
40. The method of claim 35 wherein the transitioning of the first
element to the first configuration comprises expanding the first
element to approach an interior wall of the blind void.
41. The method of claim 35, wherein the third configuration of the
second element is substantially identical to the second
configuration of the first element.
42. The method of claim 35, further comprising observing the second
configuration of the second element to at least approximate at
least one parameter of the blind void.
43. The method of claim 42, further comprising: selecting an
artificial implant having a parameter substantially corresponding
to the parameter of the blind void; and inserting the artificial
implant into the blind void.
44. The method of claim 42, wherein the observing comprises at
least one of direct visual observation and electronic
observation.
45. The method of claim 35, wherein said apparatus further
comprises an actuator element coupled to at least said first
element; and further comprising actuating said actuator element to
transition said first elements to the second configuration.
46. The method of claim 45, wherein said actuator element is
coupled to said second element, and wherein said actuating
transitions said second element to the third configuration.
47. An apparatus for measuring a blind void comprising: a first
flexible member adapted for insertion into a blind void; a second
flexible member responsive to said first flexible member so that a
change in configuration of said first flexible member results in a
change to said second flexible member; and an actuator for changing
the configuration of said first flexible member.
48. The device of claim 47, wherein at least one of said first and
second elements are at least partially formed of a flexible
material.
49. The device of claim 48, wherein said second element is at least
partially formed of a flexible material, and wherein said
configuration of said second element is defined by an outward
deformation of said flexible material.
50. The device of claim 48, wherein said first element is at least
partially formed of a flexible material, and wherein said
expandability of said first element includes outward deformation of
said flexible material.
51. The device of claim 48, wherein at least one of said first and
second elements comprises a pair of said flexible strips of
material arranged generally opposite one another.
52. The device of claim 47, wherein said first element is adapted
to engage an interior wall surrounding the blind void.
53. The device of claim 47, wherein said first element is adapted
to approach an interior wall surrounding the blind void.
54. The device of claim 47, wherein said first element has an
initial configuration adapted for insertion into the blind void in
a minimally invasive manner.
55. The device of claim 47, wherein said second configuration of
said second element is substantially identical to said first
configuration of said first element.
56. The device of claim 47, wherein said second configuration of
said second element is subject to direct visualization.
57. The device of claim 47, wherein said second configuration of
said second element is subject to at least one of electronic and
mechanical measurement.
58. The device of claim 47, further comprising an actuator coupled
to said first element, wherein actuation of said actuator expands
said firs element to at least approximate said parameter.
Description
REFERENCE TO PENDING PRIOR PATENT APPLICATION
[0001] This patent application claims benefit of pending prior U.S.
Provisional Patent Application Ser. No. 60/215,486, filed Jun. 30,
2000 by Lehmann K. Li for REMOTE MEASURING APPARATUS AND METHOD,
which patent application is hereby incorporated herein by
reference.
FIELD OF THE INVENTION
[0002] This invention relates to the field of surgical devices used
primarily for the repair or replacement of human tissue, including,
but not limited to, the nucleus pulposus of the spine. The
invention further relates to the method of using such devices.
BACKGROUND OF THE INVENTION
[0003] The spinal column is a flexible chain of closely linked
vertebral bodies. In a normal human spine there are seven cervical,
twelve thoracic and five lumbar vertebral bodies. Below the lumbar
vertebrae are the sacrum and coccyx. Each individual vertebra has
an outer shell of hard, dense bone. Inside the vertebra is a
honeycomb of cancellous bone containing red bone marrow. All of the
red blood cells and many of the white blood cells are generated
inside this cancellous bone, where the blood cells mature before
being released into the blood circulation.
[0004] The spinal disc serves as a cushion between the vertebral
bodies to permit controlled motion. A healthy disc consists of
three components: a gelatinous inner core called the nucleus
pulposus; a series of overlapping and laminated plies of tough
fibrous rings called the annulus fibrosus; and two superior and
inferior thin cartilage layers, connecting the disc to the thin
cortical bone of the vertebral bodies, called the endplates.
[0005] The spinal disc may be displaced or damaged due to trauma or
disease, such as a herniation or degenerative disc disease.
[0006] A herniated disc may bulge out and compress itself onto a
nerve, resulting in lower leg pain, loss of muscle control, or
paralysis. To treat a herniated disc, the offending nucleus
portions are generally removed surgically.
[0007] Disc degeneration gradually reduces disc height, forcing the
annulus to buckle, tear or separate radially or circumferentially,
and causing persistent and disabling back pain. Degenerative disc
disease is generally treated presently by surgically removing the
nucleus and fusing the adjacent vertebral bodies to stabilize the
joint.
[0008] In either case, whether removing a portion of the nucleus or
all of the nucleus, these procedures ultimately place greater
stress on adjacent discs to compensate for the lack of motion,
which may cause premature degeneration of those adjacent discs.
[0009] Modern trends in surgery include the restoration of bodily
function and form (i.e., repair) of anatomical structures through
the use of minimally invasive surgical techniques. The ability to
surgically repair damaged tissues or joints, creating as few and as
small incisions as possible, produces less trauma, less pain and
better clinical outcomes in general.
[0010] An emerging technique to treat degenerative disc disease is
to replace the degenerated nucleus with a prosthetic nucleus in an
attempt to restore function, versus fusion which severely limits
the function of the spine. Since a degenerated nucleus can be
removed using relatively small diameter instruments (e.g. 5 mm or
less), this approach is more conducive to minimally invasive
techniques.
[0011] A deficiency of current minimally invasive surgical
techniques to replace the nucleus is the difficulty in determining
whether enough space in the disc has been created to properly fit
an implant. Creating the proper dimension cavity may be
particularly important when implanting a device that expands, such
as with a hydrogel implant. If the cavity created is larger than
the implant, unintended implant movement or instability can occur.
If the cavity created is smaller than the implant, an implant
either may not fit, may not be positioned correctly or an
expandable device may not achieve its proper functional shape.
SUMMARY OF THE INVENTION
[0012] It is, therefore, one object of the present invention to
provide a device and method for determining how much space is
created in human tissue, particularly when the space is in a
visually impaired location.
[0013] A further object of the invention is to provide a device and
method for determining how much space is created in the inner
portion of the intervertebral disc space to facilitate the
implantation of an artificial nucleus pulposus. The present
invention is adapted to be placed through a small opening created
in the annulus to minimize trauma to surrounding tissue.
[0014] With the above and other objects in view, a feature of the
invention is the provision of a device for determining parameters
of a blind void. The device comprises an elongated rigid rod, and
an actuator extending lengthwise of the rod and slidably movable
relative to the rod, the actuator having a distal end for insertion
into the void. A first flexible element is fixed at one end thereof
to the rod proximate the distal end of the rod. A second flexible
element is fixed at one end thereof to the rod and proximally
removed from the distal end of the rod and from the first element.
Movement of the actuator is operative to cause equal movements of
the distal end portions of the first and second elements, to cause
the first element to bulge outwardly from the rod to engage
interior walls of the void and to cause the second element to bulge
outwardly in a configuration substantially duplicative of the first
element bulge, the second element being outside of the void and
subject to observation.
[0015] In accordance with a further feature of the invention, there
is provided a method for determining parameters of a blind void,
the method comprising the steps of providing a device comprising an
elongated rigid rod, a first flexible element fixed at one end
thereof to the rod proximate a distal end of the rod, a second
flexible element fixed at one end thereof to the rod and proximally
removed from the distal end of the rod and from the first element,
and an actuator extending lengthwise of the rod and engageable with
distal end portions of the first and second elements. The method
further includes the steps of inserting the distal end of the
actuator and the first element into the void, moving the actuator
to cause movements of the distal end portions of the first and
second elements, to cause the first element to bulge outwardly to
engage interior walls of the void, and to cause the second element
to bulge outwardly in a configuration duplicative of the first
element bulge, the second element being outside of the void, and
determining from the size of the second element the size of the
first element and thereby the void.
[0016] The above and other features of the invention, including
various novel details of construction and combinations of parts and
method steps, will now be more particularly described with
reference to the accompanying drawings and pointed out in the
claims. It will be understood that the particular device and method
embodying the invention are described by way of illustration only
and not as limitations of the invention. The principles and
features of this invention may be employed in various and numerous
embodiments without departing from the scope of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
[0017] Reference is made to the accompanying drawings in which is
shown an illustrative embodiment of the invention, from which its
novel features and advantages will be apparent.
[0018] In the drawings:
[0019] FIG. 1 is a perspective view of one form of device
illustrative of an embodiment of the invention;
[0020] FIG. 2 is a diagrammatic top view of the device of FIG. 1
deployed in a spinal disc;
[0021] FIG. 3 is similar to FIG. 1, but shows the device in another
operative configuration; and
[0022] FIG. 4 is similar to FIG. 2, but shows the device in a
parameter determining configuration.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0023] Referring to FIG. 1, it will be seen that an illustrative
inventive device 10 includes an elongated rigid rod 20, in the form
of at least one, and preferably two, plates 22. When the device
includes two plates, the plates extend parallel to each other.
[0024] An actuator 24 extends lengthwise of the rod 20 and is
slidably movable relative to the rod 20. When the rod 20 includes
two plates 22, the actuator 24 is slidably disposed between the two
plates.
[0025] A first flexible element, such as a strip 26, is fixed at a
proximal end portion 28 thereof to the rod 20 proximate the distal
end 30 of the rod. The element 26 may be a bendable strip of metal
having a distal free end 32. A first flexible element 26 is fixed
to each of the plates 22.
[0026] Mounted on a distal end 34 of the actuator 24 is a first
engagement member 36 which is engageable with the distal end 32 of
each of the first elements 26. The first engagement member 36 may
be an end-piece 38 fixed to the distal end 34 of the actuator
24.
[0027] A second flexible element, such as a strip 40, is fixed to
each of the plates 22 at a proximal end portion 42 of the element.
The element 40 is of the same configuration, size and material as
the element 26 and is provided with a distal free end 44. A
flexible second element 40 is fixed to each of the plates 22
proximally of the distal end 30 of the rod 20 and proximally of the
first flexible element 26.
[0028] Mounted on each of the plates 22 on a side opposite from the
actuator 24 is a second engagement member 50 connected to the
actuator 24 by a connecting pin 52. The second engagement member 50
may be a block 54.
[0029] The rod 20 is provided with a grip portion 46 at the
proximal end 47 of the rod by which the rod may be gripped by an
operator (not shown). The actuator 24 is provided with a
manipulable portion, such as a cross-bar 48, such that an operator
may hold the device 10 in one hand by gripping the rod grip portion
46 and the actuator cross-bar 48, and by squeezing the cross-bar
toward the grip portion, cause the actuator to move proximally
relative to the plates 22. The plates are each provided with a slot
56 through which extends a cross-bar portion, such that the
cross-bar 48 may readily move relative to plates 22. Similarly, the
plates 22 are each provided with a slot 58 through which extends
the connecting pin 52, permitting movement of the engagement block
54 relative to the plates 22.
[0030] In operation, the device 10, as shown in FIG. 1, is inserted
into a void, such as a spinal disc cavity 60 from which the nucleus
pulposus has been removed (FIG. 2). By manipulation of the rod grip
portion 46 and actuator cross-bar 48, the actuator 24 is made to
move proximally relative to the rod 20. Proximal movement of the
actuator 24 carries with it proximal movement of the end piece 38
and engagement block 54 which, contacting the element free distal
ends 32,44, respectively, cause proximal movement of the flexible
element free ends 32,44, while the flexible element proximal ends
28,42 remain fast to their respective plates 22. The elements are
thus caused to bulge outwardly (FIGS. 3 and 4) until the first
element 26 engages interior walls 62 of the cavity 60, stopping
movement of the actuator 24.
[0031] At this point, the first element 26 is hidden from view and
the extent of the bulge is not ordinarily observable. However,
because the second flexible element 40 is of the same
configuration, size and material as the first element and expands
in a manner duplicating the expansion of the first element, and is
in an observable disposition, the size of the spinal disc cavity
may be determined by observation of the second element. While it is
intended that "observation" includes visual observation and
mechanical measurement, it is apparent that "observation" can be
undertaken by optical or automatic data gathering instruments in
combination with computers and/or read-out devices.
[0032] It should also be appreciated that device 10 may be used to
determine cavity sizes in a variety of different directions. Thus,
for example, in FIGS. 2-4, device 10 is shown oriented so as to
measure cavity size in a substantially horizontal direction.
However, it should also be appreciated that device 10 may be
oriented, or modified, so as to measure cavity size in a
substantially vertical direction, or in some other direction.
[0033] There is thus provided a device and method for determining
the space available in a blind void, and particularly in a spinal
disc cavity vacated by extraction of the nucleus pulposus
therefrom.
[0034] It is to be understood that the present invention is by no
means limited to the particular construction herein disclosed
and/or shown in the drawings, but also comprises any modification
or equivalent within the scope of the claims.
* * * * *