U.S. patent application number 13/521747 was filed with the patent office on 2015-04-23 for locking between levels of a multi-level helix device.
This patent application is currently assigned to NLT-SPINE LTD.. The applicant listed for this patent is Dvir Keren, Tzony Siegal. Invention is credited to Dvir Keren, Tzony Siegal.
Application Number | 20150112436 13/521747 |
Document ID | / |
Family ID | 43919605 |
Filed Date | 2015-04-23 |
United States Patent
Application |
20150112436 |
Kind Code |
A1 |
Siegal; Tzony ; et
al. |
April 23, 2015 |
LOCKING BETWEEN LEVELS OF A MULTI-LEVEL HELIX DEVICE
Abstract
An inter-level locking mechanism of a multi- level medical
device is disclosed. The locking mechanism includes (a) an
elongated element (100) having a plurality of flexing regions,
wherein the elongated element assumes a straightened configuration
for introduction into the body, and wherein the elongated element
assumes a closed helix configuration with a first portion of the
elongated element coming in overlapping contact with a second
portion of the elongated element in the closed helix configuration,
and (b) at least one locking element deployable so as to
interconnect the first and second portions of the elongated element
so as to tighten together the overlapping portions of the elongated
element, thereby stabilizing the closed helix configuration.
Inventors: |
Siegal; Tzony; (Moshav
Shoeva, IL) ; Keren; Dvir; (Tel Aviv, IL) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Siegal; Tzony
Keren; Dvir |
Moshav Shoeva
Tel Aviv |
|
IL
IL |
|
|
Assignee: |
NLT-SPINE LTD.
Kifar Saba
IL
|
Family ID: |
43919605 |
Appl. No.: |
13/521747 |
Filed: |
February 16, 2011 |
PCT Filed: |
February 16, 2011 |
PCT NO: |
PCT/IB2011/050647 |
371 Date: |
July 12, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
61304857 |
Feb 16, 2010 |
|
|
|
Current U.S.
Class: |
623/11.11 |
Current CPC
Class: |
A61F 2/44 20130101; A61F
2002/4415 20130101; A61F 2220/0025 20130101; A61F 2002/3052
20130101; A61F 2002/30624 20130101; A61F 2002/4635 20130101; A61F
2002/2835 20130101; A61F 2002/30462 20130101; A61B 17/8852
20130101; A61F 2220/0033 20130101; A61F 2/02 20130101; A61F
2002/30469 20130101; A61F 2002/30331 20130101; A61F 2/4455
20130101; A61F 2220/0075 20130101; A61F 2002/448 20130101; A61F
2002/30522 20130101; A61B 17/7094 20130101; A61F 2002/30632
20130101; A61F 2002/30367 20130101 |
Class at
Publication: |
623/11.11 |
International
Class: |
A61F 2/02 20060101
A61F002/02 |
Claims
1. An inter-level locking mechanism of a multi-level medical
device, comprising: (a) an elongated element having a plurality of
flexing regions, wherein said elongated element assumes a
straightened configuration for introduction into the body, and
wherein said elongated element assumes a closed helix configuration
with a first portion of said elongated element coming in
overlapping contact with a second portion of said elongated element
in said closed helix configuration; and (b) at least one locking
element deployable so as to interconnect said first and second
portions of said elongated element so as to tighten together said
overlapping portions of said elongated element, thereby stabilizing
the closed helix configuration.
2. The locking mechanism of claim 1, wherein said at least one
locking element comprises a flexible tensioning element anchored to
said first portion of said elongated element and passing directly
between levels of said closed helix configuration so as to tighten
together said overlapping portions of said elongated element.
3. The locking mechanism of claim 2, wherein said second portion of
said elongated element comes in overlapping contact with a third
portion of said elongated element in said closed helix
configuration, thereby defining three levels of said closed helix
configuration, and wherein said flexible tensioning element
additionally engages said third region of said elongated element,
thereby tightening together said three levels of said closed helix
configuration.
4. The locking mechanism of claim 1, wherein said second portion of
said elongated element comes in overlapping contact with a third
portion of said elongated element in said closed helix
configuration, thereby defining three levels of said closed helix
configuration, and wherein said at least one locking element
additionally engages said third region of said elongated element,
thereby tightening together said three levels of said closed helix
configuration.
5. The locking mechanism of claim 1, wherein at least part of said
elongated element is provided with protrusions and at least part of
said elongated element is provided with complementary recesses,
said projections and recesses being configured and deployed such
that, when said elongated element assumes said closed helix
configuration, said protrusions and complementary recesses
inter-engage so as to further stabilize and reinforce said closed
helix configuration.
6. The locking mechanism of claim 1, comprising further a second
locking element locking said element in a second position along
said element in addition to said at least distal portion to said
proximal portion locking element.
7. The locking mechanism of claim 1, wherein said elongated element
is formed from a plurality of links interconnected at said
plurality of flexing regions.
8. A method for locking a multi-level medical device within a body,
the method comprising the steps of: (a) inserting an elongated
element having a plurality of flexing regions, wherein said element
assumes a straightened configuration for introduction into the
body, and wherein said elongated element assumes a closed helix
configuration with a first portion of said elongated element coming
in overlapping contact with a second portion of said elongated
element in said closed helix configuration when deployed; and (b)
deploying a locking element so as to interconnect said first and
second portions of said elongated element so as to tighten together
said overlapping portions of said elongated element, thereby
stabilizing the closed helix configuration.
9. The method according to claim 8, wherein said locking element
comprises a flexible tensioning element anchored at said first
portion of said elongated element and passing directly between
levels of said closed helix configuration so as to tighten together
said overlapping portions of said elongated element.
10. The method according to claim 8, wherein at least part of an
upper or lower overlap surface of said elongated clement is
provided with protrusions and at least part of an upper or lower
overlap surface of said elongated element is provided with
complementary recesses, said projections and recesses being
configured and deployed such that, when said locking element is
deployed, said projections and recesses are locked in engagement,
thereby further stabilizing said closed helix configuration.
11. The method according to claim 8, further comprising the step of
deploying a second locking element locking between levels of said
closed helix configuration in an additional region of overlap.
12. The method according to claim 8, further comprising the step of
introducing a stabilizing substance into the inner space of said
multi-level closed helix configuration.
13. The method according to claim 8, further comprising the step of
introducing a biocompatible material into the inner space of said
multi-level closed helix configuration.
Description
FIELD OF THE INVENTION
[0001] The invention relates generally to medical devices, and more
particularly to a locking mechanism between levels of a medical
device with a multi-level helix configuration.
BACKGROUND OF THE INVENTION
[0002] A device for introduction into a body in a straight
configuration and assuming within the body a predefined curved
configuration has been disclosed in international patent
application WO 2006/072941. The device included an elongated
element formed from a number of segments interconnected so as to
form effective hinges therebetween. The elongated element is
introduced in a straight configuration within a conduit and assumes
a curved configuration when deployed. The device curved
configuration might be an in-plane one level closed loop
configuration implant or an out-of-plane closed helix with two or
more helix levels. Both devices, and more severely the out-of-plane
closed helix device, are required to maintain their configuration
in the patient body under significant deforming forces.
[0003] Thus, it would be highly advantageous to provide a locking
mechanism between levels of a medical device with a multi-level
helix configuration that would stabile and reinforce the
multi-level helix devices.
SUMMARY OF THE INVENTION
[0004] According to an embodiment of the present invention, there
is provided an inter-level locking mechanism of a multi-level
medical device including (a) an elongated element having a
plurality of flexing regions, wherein the elongated element assumes
a straightened configuration for introduction into the body, and
wherein the elongated element assumes a closed helix configuration
with a first portion of the elongated element coming in overlapping
contact with a second portion of the elongated element in the
closed helix configuration, and (b) at least one locking element
deployable so as to interconnect the first and second portions of
the elongated element so as to tighten together the overlapping
portions of the elongated element, thereby stabilizing the closed
helix configuration.
[0005] According to a further feature of an embodiment of the
present invention, at least one locking element includes a flexible
tensioning element anchored to the first portion of the medical
device and passing directly between levels of the closed helix
configuration so as to tighten together the overlapping portions of
the elongated element.
[0006] According to a further feature of an embodiment of the
present invention, the second portion of the elongated element
comes in overlapping contact with a third portion of the elongated
element in the closed helix configuration, thereby defining three
levels of the closed helix configuration, and wherein at least one
locking element additionally engages the third region of the
elongated element, thereby tightening together the three levels of
the closed helix configuration.
[0007] According to a further feature of an embodiment of the
present invention, the second portion of the elongated element
comes in overlapping contact with a third portion of the elongated
element in the closed helix configuration, thereby defining three
levels of the closed helix configuration, and wherein the flexible
tensioning element additionally engages the third region of the
elongated element, thereby tightening together the three levels of
the closed helix configuration.
[0008] According to a further feature of an embodiment of the
present invention, at least part of the elongated element may be
provided with protrusions and at least part of the elongated
element may be provided with complementary recesses, the
protrusions and recesses being configured and deployed such that,
when the elongated element assumes the closed helix configuration,
the protrusions and complementary recesses inter-engage so as to
further stabilize and reinforce the closed helix configuration.
[0009] According to a further feature of an embodiment of the
present invention, a second locking element locking the element in
a second position along the element in addition to the at least
distal portion to the proximal portion locking element may be
provided.
[0010] According to a further feature of an embodiment of the
present invention, the elongated element may be formed from a
plurality of links interconnected at the plurality of flexing
regions.
[0011] According to an embodiment of the present invention, there
is provided a method for locking a multi-level medical device
within a body comprising the steps of: (a) inserting an elongated
element having a plurality of flexing regions, wherein the clement
assumes a straightened configuration for introduction into the
body, and wherein the elongated element assumes a closed helix
configuration with a first portion of the elongated element coming
in overlapping contact with a second portion of the elongated
element in the closed helix configuration when deployed, and (b)
deploying a locking element so as to interconnect the first and
second portions of the elongated element so as to tighten together
the overlapping portions of the elongated element, thereby
stabilizing the closed helix configuration.
[0012] According to a further feature of an embodiment of the
present invention, the locking element includes a flexible
tensioning element anchored at the first portion of the elongated
element and passing directly between levels of the closed helix
configuration so as to tighten together the overlapping portions of
the elongated element.
[0013] According to a further feature of an embodiment of the
present invention, at least part of an upper or lower overlap
surface of the elongated element may be provided with protrusions
and at least part of an upper or lower overlap surface of the
elongated element may be provided with complementary recesses, the
protrusions and recesses being configured and deployed such that,
when the locking element is deployed, the protrusions and recesses
are locked in engagement, thereby further stabilizing the closed
helix configuration.
[0014] According to a further feature of an embodiment of the
present invention, a second locking element, locking between levels
of the closed helix configuration in an additional region of
overlap, may be deployed.
[0015] Additional features and advantages of the invention will
become apparent from the following drawings and description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] For a better understanding of the invention and to show how
the same may be carried into effect, reference will now be made,
purely by way of example, to the accompanying drawings in which
like numerals designate corresponding elements or sections
throughout.
[0017] With specific reference now to the drawings in detail, it is
stressed that the particulars shown are by way of example and for
purposes of illustrative discussion of the preferred embodiments of
the present invention only, and are presented in the cause of
providing what is believed to be the most useful and readily
understood description of the principles and conceptual aspects of
the invention. In this regard, no attempt is made to show
structural details of the invention in more detail than is
necessary for a fundamental understanding of the invention, the
description taken with the drawings making apparent to those
skilled in the art how the several forms of the invention may be
embodied in practice. In the accompanying drawings:
[0018] FIG. 1 illustrates a multi-level medical device in its
elongated straightened configuration , according to embodiments of
the present invention;
[0019] FIG. 2 illustrates the multi-level medical device in its
closed helix configuration, according to embodiments of the present
invention;
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0020] Certain embodiments of the present invention provide an
inter-level locking mechanism of a multi-level medical device, such
as a medical tool or an implant, wherein an elongated element
having a plurality of flexing regions assumes a straightened
configuration for introduction into the body. The elongated element
assumes a closed helix configuration with a first portion of the
elongated element coming in overlapping contact with a second
portion of the elongated element in the closed helix
configuration.
[0021] Hereinafter the term "first portion" will be used to refer
to a portion of the elongated clement which closes into overlapping
relation with another part of the elongated element. According to
certain preferred implementations, the "first portion" is at or
near the tip which is deployed first, referred to also as the
"distal" portion. The term "second portion" will be used to refer
to a portion of the elongated element upon which the first portion
is deployed in overlapping relation when formed into a closed
helical structure. The second portion is clearly "proximal"
relative to the first portion, but may be at an intermediate
position along the elongated element. The term "third portion" will
be used to refer to a portion of the elongated element upon which
the second portion is deployed in overlapping relation when formed
into a closed helical structure. Here too, the third portion is
proximal to the second portion, but may be at an intermediate
position along the elongated element, where the deployed
configuration includes additional turns of the helical
structure.
[0022] The present invention relates to "multi-level implants",
i.e., implants which have a deployed state in which at least part
of the implant is deployed in a second level or layer relative to
another part of the implant, making an out-of-plane or
three-dimensional (3D) structure. This is in contrast to an
"in-plane one level closed loop configuration implant" in which all
the elongated element plurality of links are in one plane.
[0023] The plurality of flexing regions are slightly inclined
upwards out-of-plane relative to an in-plane one level closed loop
configuration implant such that the elongated element assumes a
closed helix configuration with at least a bottom part of the
distal portion of the elongated element coming in contact with an
upper part of the elongated element when deployed in its closed
helix configuration.
[0024] The inter-level locking mechanism includes at least one
locking element deployable so as to interconnect the first and
second portions of the elongated element so as to tighten together
the overlapping portions of the elongated element, thereby
stabilizing the closed helix configuration when deployed.
[0025] FIG. 1 illustrates a multi-level implant in its elongated
straightened configuration, according to embodiments of the present
invention. Elongated element 100 assumes a straightened
configuration for insertion through into the body with a low cross
sectional profile. In certain non-limiting cases, insertion may be
performed via a delivery conduit (not shown). Elongated element 100
may be formed from links 120 interconnected at the flexing regions,
including distal link 124, mid link 126, second link 130 and
proximal link 134. The links may be made of any suitable material.
Typically preferred but non-limiting examples include plastic (e.g.
PEEK, UHMWPE, etc.), metal (e.g. Titanium, Stainless Steel, etc.),
or a combination of metal and plastic. Elongated element 100 may be
formed from plurality of links interconnected at the flexing
regions. The links described herein above are non limiting examples
of such links and furthermore other structures that may be used to
form elongated element 100 are within the scope of the present
invention. By way of example, the links described herein may be
replaced by intrinsic, or integral and/or elastic joints or by any
other structures permitting flexion.
[0026] The links may be interconnected by effective hinge axes 115
which are slightly inclined out-of-plane relative to the plane of
an in-plane one level closed loop configuration implant, resulting
in a helix-like deflected configuration when deployed within the
body. The effective hinge axes may be formed by conventional hinge
mechanisms of any type, by integrally formed hinges or by any other
structure which provides well defined flexing properties between
adjacent segments of the structure.
[0027] According to certain embodiments of the present invention,
at least one locking element that includes a flexible tensioning
element may be anchored to the first portion of the implant and
passing directly between levels of the implant so as to tighten
together said overlapping portions of said elongated element into a
closed helix configuration when deployed. The locking element may
additionally engage a third region of the elongated element,
thereby tightening together the three levels of the implant. The
locking element may engage any number of regions beyond the third
region of the elongated element described herein above, thereby
tightening together any number of levels of the multi-level helix
device according to embodiments of the present invention.
[0028] Elongated element 100 includes a flexible tensioning element
110, typically implemented as either a plastic or metal thread, and
a tightener, such as a proximal roller 140 (which may be also
typically formed either from plastic or metal. Flexible tensioning
element 110 is preferably fixedly attached to distal link 124, or
at some other location along the elongated element, and is threaded
through at least one additional link, such as mid link 126 and
proximal link 134. The other end of the tensioning element may be
connected to proximal roller 140. Proximal roller 140 is a
non-limiting example of a mechanism for tightening flexible
tensioning element 110. Other non-limiting possibilities for
tightening flexible tensioning element 110 include a direct pulling
by hand or by use of any other dedicated tool. Proximal roller 140
and tensioning element 110 prevent the device from loosening.
Tensioning element 110 may be a string, a multi-strand string,
beads or other tensioning mechanism. Proximal roller 140 may be
replaced by knobs or another drawstring mechanism.
[0029] In an alternative implementation, the tensioning element may
be anchored at or near the proximal end of the elongated element,
and then pass through one or more relatively distal segments, then
being doubled-over and passing back to the provide an end to be
tightened.
[0030] During deployment, the tightener (proximal roller 140) is
operated to draw in excess length of flexible tensioning element
110. According to certain embodiment illustrated here, roller 140
may be implemented as a simple bolt which is both rotated and
advances backwards relatively to proximal link 134.
[0031] Returning now to FIG. 1, second link 130 has an internal
hole (along its longitudinal axes) which enables proximal roller
140 to protrude into the body of second link 130 in the straight
configuration of the elongated element 100 as proximal roller 140
advanced backwards during the deployment of elongated element 100
and its folding within the patient body. In its closed helix
configuration, the proximal roller 140 is pulled back out of second
link 130 enabling attachment in between second link 130 and
proximal link 134.
[0032] FIG. 2 illustrates the multi-level implant 100 in its closed
helix configuration, according to embodiments of the present
invention. As elongated element 100 assumes a curved configuration,
proximal roller 140 is rotated (e.g. is screwed outwardly), thereby
winding flexible tensioning element 110 around proximal roller 140,
and sequentially attaching the links of elongated element 100 to
each other. As shown in FIG. 2, proximal link 134 bottom part is
connected to mid link 126 upper part and mid link upper part 126 is
connected further to distal link upper part 124. Flexible
tensioning element 110 is shown winded around proximal roller 140
and its other end 144 is anchored to distal link 124 through a hole
122 shown in FIG. 1. Flexing tensioning element 110 may be anchored
to the proximal link and the flexing tensioning element 110 may be
a string threaded through the distal link back to the proximal
link.
[0033] According to certain embodiments of the present invention,
elongated clement 100 may be provided with protrusions and at least
part of the elongated element may be provided with complementary
recesses, the projections and recesses being configured and
deployed such that, when the elongated element assumes the closed
helix configuration shown for example in FIG. 2, the protrusions
and complementary recesses inter-engage so as to further stabilize
and reinforce the closed helix configuration multi-level
implant.
[0034] As shown in FIG. 2 the flexible tensioning element may be a
string 110 and pulling the string may be done by a draw-string
roller 140 connected to the proximal link 134 of implant 100,
wherein the string 110 may be winded around the proximal roller 140
gradually attaching the distal link 124 bottom part to the proximal
portion upper part 134 through mid link 126.
[0035] According to embodiments of the present invention, a second
locking element may be used for multi-level locking the elongated
element 100 in a second position along the element in addition to
the distal link to the proximal link locking element shown in FIG.
2.
[0036] Although an exemplary embodiment of the tightener 140 is
illustrated here as a bolt, other roller arrangements, or
tighteners which are implemented as part of a delivery system
separate from the implant, may be employed.
[0037] In the closed helix configuration, multi-level implant 100
is strongly fastened, stabilized and reinforced by the inter-level
locking between distal link 124 and proximal link 134.
[0038] As shown in FIG. 2, flexible tensioning element 110 is
connected to distal link 124, passing through mid link 126
(potentially through additional links as well), and is wound over
proximal roller 140 (which is connected to proximal link 134). It
is noted that in other (not shown) embodiments, flexible tensioning
element 110 may be anchored to a link other than distal, and may be
connected to other link than the proximal one. Optionally, roller
140 may be secured to proximal link 134 using a one directional
rotation ratchet arrangement (not shown). Roller 140 may be
replaced by any other mechanism preventing tensioning element 110
from loosening.
[0039] Tightener 140 may be rolled back in order to loosen
tensioning element 110 and to allow multi-level helix implant 100
to be straightened to its initial elongated straightened
configuration, for example, for repositioning of the implant, or
removal from the body.
[0040] FIG. 2 illustrates a closed helix configuration where the
proximal link is on top of the multi-level implant and where the
distal link is at the bottom of the multi-level implant. However,
according to embodiments of the present invention, an opposite
helix configuration may be implemented where the distal link is on
top of the multi-level implant and where the proximal link is at
the bottom of the multi-level implant and both closed helix
configurations are in the scope of the present invention.
[0041] Furthermore as shown in FIG. 2, multi-level implant 100 may
have a helix configuration with 2, 3 or more levels due to the
elongated element flexing regions (links for example) that are
slightly inclined out-of-plane relative to the plane assumed by an
in-plane one level closed loop configuration elongated element.
Flexible tensioning element 110 may connect the distal link to the
proximal link through multiple helix levels and through multiple
mid links.
[0042] According to certain embodiments of the present invention, a
first tensioning clement may be used for deployment of the implant
and a second tensioning element for locking between levels of the
multi-level implant. Particularly in such cases, the element
employed for locking need not extend to the distal-most or
proximal-most segments, and may instead lock between levels at some
other position in the helical structure, or only lock between a
subset of the levels. Similarly, the locking element may be
actuated to lock the helical structure as a separate operation
after complete deployment of the structure.
[0043] Furthermore, in certain embodiments, the locking element may
not be pre-attached to the elongated element prior to deployment,
but may instead be separately introduced and deployed after
deployment of the helical structure.
[0044] Although described herein in a preferred implementation as a
tensioning clement, it should be noted that other types of locking
elements also fall within the scope of the present invention.
Examples include, but are not limited to, various forms of clip,
clamp or fastener which engage corresponding features in the
elongated element.
[0045] According to certain embodiments of the present invention,
biocompatible material may be introduced into an inner space of the
multi-level implant 100 in its closed helix configuration to
achieve various mechanical or therapeutic functions. By way of one
non-limiting set of examples, during inter-vertebral fusion, a
stabilizing substance, such as bone particles, may be injected into
the inner space of the multi-level implant 100 to promote bone
growth.
[0046] Advantageously, multi-level helix implants described above
may be locked, stabilized and reinforced by embodiments of the
present invention multi-level locking mechanism.
[0047] Another advantage of certain embodiments of the multi-level
helix implants described above is that an elongated clement
introduced in a straightened configuration through a conduit with
relatively small cross section, folds within the body into a
multi-level helix configuration with significantly larger cross
section and height comparing to the cross section and height of its
delivery conduit and where the multi-level helix implants maintain
their multi-level helix configuration due to their locking
mechanism.
[0048] Another advantage of certain embodiments of the multi-level
helix implants described above is that the elongated element is
provided with protrusions and at least part of the elongated
clement is provided with complementary recesses, the projections
and recesses being configured and deployed such that, when the
elongated element assumes the closed helix configuration the
protrusions and complementary recesses inter-engage so as to
further stabilize and reinforce the closed helix configuration
multi-level implant.
[0049] In summary, multi-level helix implants described above may
be locked, stabilized and reinforced by embodiments of the present
invention multi-level helix implants locking mechanism. After
deployment the locked multi-level helix implants assume and
maintain a significantly larger cross section and height comparing
to the cross section and height of their delivery conduit.
[0050] It is appreciated that certain features of the invention,
which are, for clarity, described in the context of separate
embodiments, may also be provided in combination in a single
embodiment. Conversely, various features of the invention which
are, for brevity, described in the context of a single embodiment,
may also be provided separately or in any suitable
sub-combination.
[0051] Unless otherwise defined, all technical and scientific terms
used herein have the same meanings as are commonly understood by
one of ordinary skill in the art to which this invention belongs.
Although methods similar or equivalent to those described herein
can be used in the practice or testing of the present invention,
suitable methods are described herein.
[0052] All publications, patent applications, patents, and other
references mentioned herein are incorporated by reference in their
entirety. In case of conflict, the patent specification, including
definitions, will prevail. In addition, the materials, methods, and
examples are illustrative only and not intended to be limiting.
[0053] 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 hereinabove. Rather the scope of the present
invention is defined by the appended claims and includes both
combinations and sub-combinations of the various features described
hereinabove as well as variations and modifications thereof, which
would occur to persons skilled in the art upon reading the
foregoing description.
* * * * *