U.S. patent application number 14/295225 was filed with the patent office on 2015-01-29 for flexible space holder.
This patent application is currently assigned to Biedermann Technologies GmbH & Co. KG. The applicant listed for this patent is Biedermann Technologies GmbH & Co. KG. Invention is credited to Lutz Biedermann, Jurgen Harms, Wilfried Matthis.
Application Number | 20150032211 14/295225 |
Document ID | / |
Family ID | 35219995 |
Filed Date | 2015-01-29 |
United States Patent
Application |
20150032211 |
Kind Code |
A1 |
Biedermann; Lutz ; et
al. |
January 29, 2015 |
FLEXIBLE SPACE HOLDER
Abstract
A flexible space holder made of at least one biocompatible,
rigid material having a tube-like body, with one or more flexible
areas is described. The flexible space holder can be temporarily or
permanently inserted into a human or animal. Furthermore, the
flexible space holder can be surrounded by an elastomeric sleeve.
Alternatively, an elastic core can be inserted into the center of
the flexible space holder.
Inventors: |
Biedermann; Lutz;
(VS-Villingen, DE) ; Harms; Jurgen; (Karlsruhe,
DE) ; Matthis; Wilfried; (Weisweil, DE) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Biedermann Technologies GmbH & Co. KG |
Donaueschingen |
|
DE |
|
|
Assignee: |
Biedermann Technologies GmbH &
Co. KG
Donaueschingen
DE
|
Family ID: |
35219995 |
Appl. No.: |
14/295225 |
Filed: |
June 3, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
11121888 |
May 4, 2005 |
8771357 |
|
|
14295225 |
|
|
|
|
60567989 |
May 4, 2004 |
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Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61F 2002/30148
20130101; A61F 2002/30566 20130101; A61F 2/442 20130101; A61F
2310/00023 20130101; A61F 2/44 20130101; A61F 2/30767 20130101;
A61F 2230/0017 20130101; A61F 2002/30818 20130101; A61F 2002/30563
20130101; A61F 2002/30841 20130101; A61F 2/4465 20130101 |
Class at
Publication: |
623/17.16 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Foreign Application Data
Date |
Code |
Application Number |
May 4, 2004 |
DE |
102004021861.7 |
Claims
1. A space holder for vertebrae and/or intervertebral discs with
space-holder and weight-transfer function for temporary or
permanent introduction into a human or animal body of at least one
biocompatible material having a tube-like body and, on the ends of
the tube-like body, means for connecting to adjacent body parts,
wherein the tube-like body has a recess to locally reduce the
rigidity of the space holder.
2. The space holder according to claim 1, wherein the tube-like
body and the means for connecting to adjacent body parts are
interconnected.
3. The space holder according to claim 1, wherein the biocompatible
material is rigid.
4. The space holder according to claim 3, wherein the biocompatible
material is selected from the group comprising titanium, titanium
alloys and plastics.
5. The space holder according to claim 1, wherein the recess is a
groove-like recess formed in the wall of said tube-like body.
6. The space holder according to claim 5, wherein the recess is an
open aperture in the wall of said tube-like body.
7. A space holder according to claim 1, wherein two recesses are
formed in the tube-like body of said space holder.
8. A space holder according to claim 7, wherein said two recesses
are groove-like recesses.
9. (canceled)
10. A space holder of claim 1, wherein said space holder includes a
flexible part which acts together with the recesses to achieve the
desired flexibility and mobility.
11. A space holder of claim 10, wherein flexible part comprises an
elastomeric sleeve.
12. A space holder of claim 1, wherein said space holder is
compressible and extendable in the axial direction and, with
reference to the means for connecting provided on the ends and is
bendable about a radial turning axis and torsionable about an axial
rotating axis.
13. A space holder according to claim 1, wherein means for
connecting the tube-like body part to adjacent body parts comprise
projections.
14. A space holder according to claim 13, wherein said projections
have serrations in the axial directions for engagement with
adjacent body parts.
15. (canceled)
16. (canceled)
17. A space holder according to claim 1, wherein means for
connecting the tube-like body part to adjacent body parts are
formed as an extension of the tube-like body part.
18. A space holder according to claim 17, wherein the extension is
integral with the tube-like body part.
19. A space holder according to claim 17, wherein the means for
connecting the tube-like body part to adjacent body parts are
disposed at an end plate detachably arranged at an end of the
tube-like body part.
20. A space holder according to claim 1, wherein the tube-like body
is surrounded by an elastic biocompatible sleeve.
21. A space holder according to claim 1, wherein said space holder
includes an elastic biocompatible core.
22. A space holder according to claim 21, wherein said elastic
biocompatible core is made from an elastomer.
23. A space holder according to claim 20, wherein the sleeve is
held by end plates arranged on the tube-like body.
24-35. (canceled)
Description
REFERENCE TO EARLIER FILED APPLICATIONS
[0001] The present invention claims the, benefit of the filing date
under 35 U.S.C. .sctn.119(e) of Provisional U.S. patent application
Ser. No. 60/567,989, filed May 4, 2004, which is hereby
incorporated by reference. The present application also claims
foreign priority benefits pursuant to 35 U.S.C. .sctn.119(a-d) for
German Patent Application No. 10 2004 02I 861.7 filed May 4, 2004
in Germany.
BACKGROUND
[0002] The invention relates to a flexible space holder. The
flexible space holder can be inserted into a human or animal on a
temporary or permanent basis.
[0003] In modern medicine, many defects in the human or animal body
can be compensated or minimized by the use of implants. For
example, space holders for vertebrae or intervertebral discs are
known to be used as replacements for a vertebral body or an
intervertebral disc.
[0004] It is important to use materials which are compatible with
the human or animal organism, so that the implant is not rejected
or does not disintegrate upon being implanted. Accordingly, the
choice of materials for implants is important and somewhat
restricted.
[0005] In addition, it is advantageous to form simple space holders
from as few parts as possible. The more parts the space holder is
made from, the harder to implant and the greater the possibility of
malfunction at the connection site. Therefore, preferably implants
are formed from as few parts as possible.
[0006] Despite these issues, space holders must fulfill several
different functions, making it desirable to use different materials
and/or several parts in forming the space holders. For example, it
is desirable for spacer holders not only to fill the space and hold
the vertebrae at a certain distance from each other, but also to
facilitate a certain degree of movement of the vertebrae towards
each other, i.e. enabling movement and articulation within certain
narrow limits.
[0007] DE 10056977 C2 describes a space holder with a
bellows-shaped piece of tubing extending in the longitudinal
direction of the implant between support elements which abut the
vertebral bodies. The bellows-shaped piece of tubing is made from a
tightly woven or knit textile material. This space holder, however,
has the disadvantage described above, in that several different
types of materials are used and are then connected to each other.
In view of the materials and construction, there is an increased
risk of possible malfunction of the space holder.
[0008] The object of the present invention is therefore to provide
flexible space holders which are made of the fewest possible parts,
yet which provide a certain degree of flexibility and mobility
within the implant or region wherein the implant is implanted.
Preferably, the space holder is made of one piece of material or a
few pieces that are easily interconnected, so that the flexible
space holder can provide the desired degree of flexibility and
mobility. In addition, the flexible space holders of the instant
invention are easy to manufacture and implant, are safe in
operation, and have a long lifetime and diverse application
possibilities.
[0009] In the prior art, space holders with the desired mobility or
elasticity are obtained using various parts connected together. In
addition, the individual parts of these prior art space holders
generally are made of different materials that are connected
together to form the space holder. This invention, however, in one
embodiment, provides for a flexible space holder made from one type
of material which imparts the desired flexibility and mobility to
the flexible space holder, by placing recesses in the actual
flexible space holder itself.
BRIEF SUMMARY
[0010] A flexible space holder for vertebrae and/or intervertebral
discs with space-holder and weight-transfer function for temporary
or permanent introduction into a human or animal body of at least
one biocompatible material comprising a tube-like body with a
recess extending along its circumference in order to locally reduce
the rigidity of the tube-like body, said tube-like body having a
first end and a second end and means for connecting said flexible
space holder to adjacent body parts at said first end and second
end of said tube-like body.
[0011] A flexible space holder for vertebrae and/or intervertebral
discs with space-holder and weight-transfer function of at least
one biocompatible material having a tube-like body, comprising at
least one recess to locally reduce the rigidity of the space holder
and means for connecting said flexible space holder to adjacent
body parts.
[0012] A flexible space holder for vertebrae and/or intervertebral
discs with space-holder and weight-transfer function comprising a
tube-like body which is elastically extendable or compressible by
about 0.5 to about 20%.
[0013] A flexible space holder for vertebrae and/or intervertebral
discs with space-holder and weight-transfer function comprising a
tube-like body with a recess surrounded by an elastic sleeve.
[0014] A space holder for vertebrae and/or intervertebral discs
with space-holder and weight-transfer function comprising a
tube-like body with a recess with an replaceable elastic core
inserted into the tube-like body.
[0015] The foregoing paragraphs have been provided by way of
general introduction, and are not intended to limit the scope of
the following claims. The presently preferred embodiments, together
with further advantages, will be best understood by reference to
the following detailed description taken in conjunction with the
accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a three-dimensional view of a space holder for
vertebrae or intervertebral discs;
[0017] FIG. 2 is a lateral view of the space holder shown in FIG.
1;
[0018] FIG. 3 is a detailed lateral view of the space holder shown
in FIGS. 1 and 2;.
[0019] FIG. 4 (a) and (c) are exploded three-dimensional views of a
second embodiment of the flexible space holder;
[0020] FIG. 4 (b) is a three-dimensional sectional view of the
second embodiment of the flexible space holder;
[0021] FIG. 5 (a)-(c) are three-dimensional views of a third
embodiment of the flexible space holder.
DETAILED DESCRIPTION OF THE DRAWINGS AND PRESENTLY PREFERRED
EMBODIMENTS
[0022] Various embodiments of the invention are illustrated in
FIGS. 1 to 5 and described herein. Elements of the various
embodiments that are substantially identical will be referred to
with the reference numerals.
[0023] The flexible space holders according to this invention have
a cylindrical tube-like body. The tube-like body has connection
elements provided on each end of said tube-like body. In addition,
the tube-like body has recess(es) along the circumference of the
tube-like body which are responsible for the flexibility of the
flexible space holder. The recess(es) can be placed anywhere along
the tube-like body provided that the recess reduces the rigidity of
the body. Preferably, the recess(es) are centered along the length
of the tube-like body. Alternatively, the recess(es) can be
off-centered.
[0024] The connection elements of the flexible space holders
preferably have corresponding means of connecting the flexible
space holder to adjacent body parts, such as vertebrae or bone.
These connection elements can be in any form provided that they are
able to connect to the adjacent body part. The exact composition
and configuration of the connection elements are well within the
purview of one of ordinary skill in the art. For example, the
connection elements can be in the form of hook-like projections on
the ends and/or recesses, grooves and openings on the surface of
the connection element so that the flexible space holder may grow
into, knit with and become part of the tissue into which it is
implanted. Because the connection elements knit or mesh completely
with the adjacent body parts, such as the vertebrae, they do not
contribute to the flexibility or mobility of the flexible space
holder. However, the grooves or recesses of the connection elements
must not be confused with the recesses (which will be described in
further detail below) found on the tube-like body which impart
flexibility and mobility to the flexible space holder in the
tube-like body part.
[0025] Preferably, the flexible space holder is stable and stiff,
especially in view of the conditions in which it is used. A rigid,
preferably flexible rigid material, is used for the flexible space
holder. Materials such as titanium, titanium alloys, plastics and
the like can be used to form the flexible space holder. Generally,
all biocompatible materials are candidates so long as they do not
cause rejection reactions or show any disintegration when placed in
the body. Other examples of biocompatible materials to form said
flexible space holder include stainless steel, nickel-titanium
alloys, nitinol, chrome alloy, cobalt chrome alloys, shape memory
alloys, materials with super elastic properties, carbon reinforced
composites, silicone, polyurethane, polyester, polyether,
polyalkene, polyethylene, polyamide, poly(vinyl) fluoride,
polyetheretherketone (PEEK), polytetrafluoroethylene (PTFE) and
shape memory materials or alloys, such as nickel titanium or
nitinol.
[0026] The recesses in the tube-like body can preferably be
provided in the form of groove-shaped recesses or open apertures in
the walls of the tube-like body as described above. The shape,
number and arrangement of the recesses can be adjusted from case to
case depending upon the load requirements as will be appreciated by
those of ordinary skill in the art.
[0027] In order to satisfy the diverse functions of the flexible
space holder, including weight transfer, the recess(es) can be
provided in the form of a helix running around the wall of the
tube-like body. The use of the helical shaped recess is especially
advantageous in this case because free spaces are present between
adjacent fillets of the helical shaped recess. Aside from being
easier to manufacture and the associated larger choice of material
that could be used, this embodiment also has the advantage of
achieving greater flexibility than the prior art space holders.
Although a helix is described, it will be appreciated by those
skilled in the art that other shaped recesses can be used to
achieve the desired flexibility and mobility in the tube-like
body.
[0028] In another embodiment, two recesses can be provided in the
wall of the tube-like body in the form of a twin-track or a
two-flight helix. In this way, two helical shaped recesses can be
arranged inside each other. If the area of the helix-shaped recess
has the same height, two helix-shaped recesses of double pitch can
be provided instead of one helix-shaped recess of a low pitch.
[0029] In order to further refine the mobility and flexibility of
the flexible space holder, an elastic sleeve can be placed around
the tube-like body. Alternatively, an elastic core can be inserted
into the tube-like body. Such an elastic core or elastic sleeve,
comprising, preferably of an elastomer, offers the advantage that
it allows the elasticity or rigidity of the tube-like body or space
holder to be precisely adjusted by choosing the material of the
elastic core or elastic sleeve so that the elastic core or elastic
sleeve has the desired elasticity. In addition to elastomers, other
engineered polymers can be used to form the elastic sleeve or
elastic core provided that they have the desired properties.
[0030] The connection elements or the means for connecting the
tube-like body to adjacent body parts may be arranged either
integrally with the tube-like body or detachably on the ends of the
tube-like body. An example of a detachable connector includes end
plates that can be screwed onto the ends of the tube-like body. It
will be appreciated by those of ordinary skill in the art that
other types of connections can be used.
[0031] Detachable end plates or end plates connected integrally
with the tube-like body are preferably used when at least one
sleeve of elastic material is arranged around the tube-like body
with the recesses, or at least one elastic core is provided within
the tube-like body for the purpose of achieving the desired
elasticity'or mobility.
[0032] Through the use of modular-like arrangement of tube-like
body with corresponding recesses, and core and/or sleeve, and the
use of different components of different rigidity, the damping
ability of the flexible space holder can be defined. The
combination of a flexible space holder with recesses as well as a
space holder having parts made of a flexible material, enables the
flexible space holder of the instant invention to have the desired
flexibility and mobility and the specification of each particular
element of the flexible space holder is well within the skill of
one in the art. With this construction, it is possible to realize
compression, torsion and/or expansion zones in a simple and
reliable manner, especially in an integral flexible space
holder.
[0033] To alter the characteristics of the flexible space holder,
the composition of the components can simply be changed. For
example, a core of different rigidity or a different sleeve can be
used in conjunction with the flexible space holder comprising a
tube-like body with recesses. Although it is conceivable that a
sleeve and a core can be used simultaneously together with a
flexible tube-like body, for the sake of simplicity it will usually
only be a combination of tube-like body and core or tube-like body
and sleeve. In this regard, the sleeve also offers the further
advantage of protecting the tube-like body with the preferably
helix-shaped recesses against external influences, whereas, the
tube-like body actually protects the core when the core is
used.
[0034] Both core and sleeve can advantageously be held by the
arrangement of end plates on the ends of the tube-like body, with,
in the case of the arrangement of a sleeve, the end plates
projecting preferably beyond the tube-like body and thus having a
larger diameter than the tube-like body. The end plates can at
least partly, that is on one side, be connected integrally with the
tube-like body, such that a beaker-like shape is obtained. In
addition, the end plates can be connected detachably either on one
side or on two sides to the tube-like body, for example via a screw
or thread connection. In this regard, the outer thread can be
provided both on the end plate and on the tube-like body.
[0035] Preferably, the flexible space holder or the tube-like body
with the material recesses for obtaining flexibility and mobility
is extensible or compressible in its longitudinal direction along
the space holder longitudinal axis by 0.5 to 20%, especially 1 to
15%, and bendable about a radial axis perpendicular to the
longitudinal axis of the space holder, so that tube-like body can
be pivoted by approximately 0.5 to 10, especially 1 to 6 degrees
with reference to the longitudinal axis. In addition, in a
preferred embodiment, a torsional movement of 0.5.degree. to
2.5.degree. about the longitudinal axis is possible.
[0036] FIG. 1 is a three-dimensional view of a first embodiment of
the flexible space holder, in accordance with the invention.
Flexible space holder 10 has a tube-like body 1 and two connection
elements 2 provided at each end of the tube-like body 1 for
connecting the space holder 10 to the adjacent body parts, e.g.
bones or cartilage in, for example, the human body.
[0037] Connection elements 2, which are arranged at the ends of the
tube-like body 1, have identical shapes in the embodiment shown,
but each may also have a different shape. In the embodiment shown,
the connection elements 2 are integral to the tube-like body have
serrations 3 on each free end of their ends that can engage with
the adjacent body tissue at the site of implantation. Serrations 3
are formed by triangular recesses 5 on both ends of space holder
10, such that trapezoidal serrations 3 are formed that can engage
with and cling on to adjacent body tissue.
[0038] In addition, connection elements 2 may have diamond-shaped
cavities 4 as shown in FIG. 2, that are adjacent to each other
around the entire circumference of cylinder jacket surface of
connection elements 2. As a result, the respective connection
element is formed by a large number of diamond-shaped
interconnected fillets 6, with the tips of the diamonds formed by
fillets 6 cut-off so that trapezoidal serrations 3 are formed.
[0039] Tube-like body 1 between connection elements 2 on each end
of the tube-like body includes, in the embodiment shown, a
helix-shaped recess 7 in the cylinder itself, around the
circumference of the tube-like body. With this construction, the
wall 11 of the flexible space holder as seen in FIG. 3 itself
assumes a helix shape.
[0040] Flexible space holder 10 is formed overall as a hollow
cylinder, tube-like body 1 with recesses 7 formed in the material
of the tube-like body, around the circumference of the body between
the connection elements 2. This design provides for a moveable
elastic area, even if the flexible space holder 10, itself is
formed from an essentially stiff or rigid material, such as
titanium or a titanium alloy. Through the use of recesses 7 in the
tube-like body itself, the flexible space holder 10 receives a
design-related elasticity in the region of the tube-like body 1,
which makes it possible to dispense with provision of a separate
elastic material in this area to obtain elasticity or mobility of
the device. With this design, a flexible space holder can be made
from a single piece of material.
[0041] Moreover, by using the helix-shaped recesses 7, the
tube-like body 1 is extendable and compressible along longitudinal
axis 9 of flexible space holder 10 arid bendable about a rotary
axis perpendicular to longitudinal axis 9, which for example is
illustrated by axis 8 in FIG. 2. In this particular embodiment, the
helix shape of the recess 7 enables balanced elasticity or mobility
in the most directions that the vertebrae would move. Naturally,
however, it will be appreciated by those skilled in the art that
other shapes of recesses and a different number and arrangement of
these recesses are possible. Furthermore, various different shapes
can be used to adapt to individual cases or load profiles.
[0042] FIG. 4, in sub-figures (a) and (c), shows two different
exploded three-dimensional views of a second embodiment of a
flexible space holder 100 with a tube-like body 101. A sectional
view of a second embodiment is shown in FIG. 4(b). In this second
embodiment, the tube-like body is sealed on the lower side by an
end plate 125 connected integrally with the tube-like body 101, so
that a beaker-like shape results.
[0043] As illustrated in this second embodiment, tube-like body 101
has in its walls 111 a helix-shaped recess 107 that imparts desired
flexibility in accordance with the invention to the tube-like body
101. To be able to further adjust the stiffness of the flexible
space holder 100, 101 a replaceable core element 130 of an
elastomeric material is inserted into the tube-like body. The
replaceable core element 130 is held on the lower side by end plate
125 and on the upper-side by end plate 126 in tube-like body 101.
It will be appreciated by those skilled in the art that the
rigidity and material used for the replaceable core element will
impact the elasticity and rigidity of the flexible space holder.
End plate 126 on the upper side of the flexible space holder has an
external thread 127, so that it can be screwed into internal thread
128 of tube-like body 101 located on the upper end in the inside of
tube-like body 101 in this embodiment. End plate 126 also has a
shoulder which lies tightly against wall 111. Serrations 103 are
Provided all around the end of wall 111 and project over end plates
125 and 126 and can engage with adjacent tissue in order to hold
the space holder firmly in position.
[0044] End plate 126 also has engagement openings 129 so that end
plate 126 can be screwed into the tube-like body 101. End plates
125 and 126 may additionally be roughened or coated by a bio-active
material to assist with engagement to adjacent body tissue.
Examples of suitable bio-active materials include, but are not
limited to, ceramics such as hydroxypatite coatings, biopolymers
such as chitosan, and bio-active glass. The choice of a bio-active
materials is well within the purview of one of ordinary skill in
the art.
[0045] A third embodiment of a flexible space holder is shown in
FIG. 5, sub-figures (a)-(c). Sub-figures (a) and (c) represent an
exploded three-dimensional view of the flexible space holder, while
sub-figure (b) shows a three-dimensional sectional view of the
flexible space holder.
[0046] The embodiment of FIG. 5 includes a helix-shaped recess 207
in body wall 211 of tube-like body 201. The lower side of the
tube-like body 201 is closed by an integrally arranged end plate
225, so that a beaker-like shape described above results. The end
plate 225 is formed so that it has a larger outer diameter than
tube-like body 201, in which the helix-shaped recess 207 is
arranged in the material of the tube-like body 201, so a shoulder
is created that forms a receptacle for a tube-like sleeve 230 of
elastomeric material. Elastic sleeve 230 is pushed over tube-like
body 201 so that the tube-like body is completely surrounded by the
sleeve. An end plate 226 is screwed onto tube-like body 201 at its
upper end by means of a thread connection. In this regard, the
outer thread 227 of end plate 226 engages with internal thread 228
of tube-like body 201, so that sleeve 230 is held firm between end
plates 225 and 226. Sleeve 230 also serves to adjust the overall
rigidity of the flexible sleeve device, in that simply exchanging
sleeve 230, in a manner similar to exchanging core 130, described
with respect to the embodiment of FIG. 4, makes it possible to
simply vary the rigidity of the implant 100 and 200, as well as the
flexibility and mobility.
[0047] Pyramid-shaped serrations 203, which serve to engage the
flexible space holder with the adjacent tissue to firmly anchor the
space holder; are provided on end plates 226 and 225. Lid 226 also
has engagement openings 229, so that end plate 226 can be screwed
onto tube-like body 201.
[0048] The embodiments described above and shown herein are
illustrative and not restrictive. The scope of the invention is
indicated by the claims, including all equivalents, rather than by
the foregoing description and attached drawings. The invention may
be embodied in other specific forms without departing from the
spirit and scope of the invention.
* * * * *