U.S. patent application number 13/351531 was filed with the patent office on 2012-06-07 for replacement or supplementation of a nucleus pulposus using a hydrogel.
This patent application is currently assigned to Synthes USA, LLC. Invention is credited to Alastair J.T. CLEMOW, Michael F. KEANE, Nigel G. SMITH, Edward VRESILOVIC.
Application Number | 20120143338 13/351531 |
Document ID | / |
Family ID | 35149030 |
Filed Date | 2012-06-07 |
United States Patent
Application |
20120143338 |
Kind Code |
A1 |
VRESILOVIC; Edward ; et
al. |
June 7, 2012 |
REPLACEMENT OR SUPPLEMENTATION OF A NUCLEUS PULPOSUS USING A
HYDROGEL
Abstract
A nucleus pulposus of an intervertebral disc is supplemented or
replaced by a physiologically fully hydrated solid hydrogel
intervertebral body comprising a polyvinyl alcohol copolymer,
wherein the solid hydrogel intervertebral body exhibits an osmotic
pressure of from 0.1 to 0.3 megapascals prior to insertion into a
patient, the solid hydrogel intervertebral body having a ratio of
length to principal transverse dimension not less than about
5:1.
Inventors: |
VRESILOVIC; Edward;
(Ardmore, PA) ; KEANE; Michael F.; (Downingtown,
PA) ; CLEMOW; Alastair J.T.; (Princeton, NJ) ;
SMITH; Nigel G.; (Norwich, GB) |
Assignee: |
Synthes USA, LLC
West Chester
PA
|
Family ID: |
35149030 |
Appl. No.: |
13/351531 |
Filed: |
January 17, 2012 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12568577 |
Sep 28, 2009 |
8118874 |
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13351531 |
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11134309 |
May 23, 2005 |
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12568577 |
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60572764 |
May 21, 2004 |
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Current U.S.
Class: |
623/17.16 |
Current CPC
Class: |
A61B 17/3472 20130101;
A61B 17/3468 20130101; A61F 2/442 20130101; A61L 27/00 20130101;
A61F 2/4611 20130101; A61F 2002/4627 20130101; A61F 2250/0098
20130101; A61F 2002/30242 20130101; A61F 2002/4495 20130101; A61F
2002/3008 20130101; A61F 2230/0071 20130101; A61L 27/52 20130101;
A61F 2002/444 20130101 |
Class at
Publication: |
623/17.16 |
International
Class: |
A61F 2/44 20060101
A61F002/44 |
Claims
1. A physiologically fully hydrated solid hydrogel intervertebral
body comprising: a polyvinyl alcohol copolymer, wherein the solid
hydrogel intervertebral body exhibits an osmotic pressure of from
0.1 to 0.3 megapascals prior to insertion into a patient, and
wherein the solid hydrogel intervertebral body has a ratio of
length to principal transverse dimension not less than about
5:1.
2. The solid hydrogel intervertebral body of claim 1, wherein the
body has a ratio of length to principal transverse dimension of
about 350:1.
3. The solid hydrogel intervertebral body of claim 1, wherein the
body has an elastic modulus between about 0.05 megapascals and
about 4.0 megapascals.
4. The solid hydrogel intervertebral body of claim 1, wherein the
body has a generally cylindrical shape.
5. The solid hydrogel intervertebral body of claim 1, wherein the
body has at least one portion with a cross-sectional area greater
than a principal cross-sectional area of said body.
5. The solid hydrogel intervertebral body of claim 1, wherein the
body has at least one end provided with a terminal portion of
transverse cross-sectional area greater than a principal
cross-sectional area of said body.
6. The solid hydrogel intervertebral body of claim 1, wherein the
body has at least one end provided with a flared terminal portion
of transverse cross-sectional area greater than a principal
cross-sectional area of said body.
7. The solid hydrogel intervertebral body of claim 1, wherein the
body has at least one end provided with a generally spherical
terminal portion of transverse cross-sectional area greater than a
principal cross-sectional area of said body.
8. The solid hydrogel intervertebral body of claim 1, wherein the
body has at least one portion between its ends with a transverse
cross-sectional area greater than a principal cross-sectional area
of said body.
9. The solid hydrogel intervertebral body of claim 1, wherein the
body further comprises poly(vinylpyrrolidone).
10. The solid hydrogel intervertebral body of claim 1, wherein the
body comprises a radiopaque material.
11. The solid hydrogel intervertebral body of claim 10, wherein the
radiopaque material is barium sulfate.
12. The solid hydrogel intervertebral body of claim 1, wherein the
body has a ratio of length to principal transverse dimension of
about 40:1.
13. The solid hydrogel intervertebral body of claim 1, wherein the
body has a ratio of length to principal transverse dimension of
about 100:1.
14. The solid hydrogel intervertebral body of claim 1, wherein the
body has a ratio of length to principal transverse dimension of
about 200:1.
15. The solid hydrogel intervertebral body of claim 1, wherein the
body has a generally cylindrical shape.
16. A physiologically fully hydrated solid hydrogel intervertebral
body comprising a polyvinyl alcohol copolymer, wherein the fully
hydrated solid hydrogel intervertebral body is made by a process
comprising the step of: contacting a hydrogel body comprising a
polyvinyl alcohol copolymer with an aqueous isotonic solution for a
period of time sufficient to achieve physiological full hydration,
wherein the solid hydrogel intervertebral body exhibits an osmotic
pressure of from 0.1 to 0.3 megapascals prior to insertion into a
patient, and wherein the solid hydrogel intervertebral body has a
ratio of length to principal transverse dimension not less than
about 5:1.
17. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the contacting step comprises immersing the hydrogel
body in the aqueous isotonic solution.
18. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the aqueous isotonic solution has an osmotic pressure
of about 0.2 megapascals.
19. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the aqueous isotonic solution further comprises a
polymer.
20. The fully hydrated solid hydrogel intervertebral body of claim
19, wherein the polymer is selected from the group consisting of
poly(ethylene glycol), dextran, and mixtures thereof.
21. The fully hydrated solid hydrogel intervertebral body of claim
20, wherein the polymer is dextran.
22. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body has a ratio of length to principal transverse
dimension of about 350:1.
23. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body has an elastic modulus between about 0.05
megapascals and about 4.0 megapascals.
24. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body has a generally cylindrical shape.
25. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body further comprises poly(vinylpyrrolidone).
26. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body comprises a radiopaque material.
27. The fully hydrated solid hydrogel intervertebral body of claim
26, wherein the radiopaque material is barium sulfate.
28. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body has a ratio of length to principal transverse
dimension of about 40:1.
29. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body has a ratio of length to principal transverse
dimension of about 100:1.
30. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body has a ratio of length to principal transverse
dimension of about 200:1.
31. The fully hydrated solid hydrogel intervertebral body of claim
16, wherein the body is isotonic with respect to surrounding
physiological fluid prior to implantation within the physiological
fluid.
Description
CROSS REFERENCE TO RELATED APPLICATION
[0001] This application is a divisional of U.S. application Ser.
No. 12/568,577, filed Sep. 28, 2009, which is a divisional
application of U.S. application Ser. No. 11/134,309, filed on May
23, 2005, which claims priority under 35 U.S.C. .sctn.119(e) to
U.S. application Ser. No. 60/572,764, filed May 21, 2004, all of
which are incorporated by reference herein in their entirety.
FIELD OF THE INVENTION
[0002] The present invention relates to replacing or supplementing
the natural nucleus pulposus of the intervertebral disc and more
particularly to replacing or supplementing a nucleus pulposus using
an elongated hydrogel implant.
BACKGROUND OF THE INVENTION
[0003] Chronic back pain, typically lower back pain, caused by
injury or age-related degeneration of an intervertebral disc is a
condition experienced by many patients.
[0004] Current treatment options for back pain range from
conservative bed rest to highly invasive surgical procedures
including spinal fusion and total disc replacement.
[0005] The human intervertebral disc is comprised of two major
structures, an outer or peripheral tendinous structure, referred to
as the annulus fibrosus or annulus, and an inner gelatinous nucleus
pulposus located in a generally central region within the annulus
fibrosus. Degeneration of the nucleus t typically associated with
natural ageing, leads to disc degradation and loss of function.
Consequently, another surgical option for the relief of back pain
is replacement of the nucleus, leaving the annulus intact. The aim
of nucleus replacement is to relieve pain, to restore healthy
physiological function to the disc, and to prevent additional wear
on the annulus.
[0006] In view of the gelatinous nature of the nucleus pulposus,
the use of hydrogels to replace the natural nucleus pulposus has
been proposed and materials and methods for such replacement have
been proposed.
[0007] Hydrogels are typically formed from solid, generally
insoluble hydrophilic polymers and, in their hydrated state, have a
generally water-swollen structure. It has been proposed to design
hydrogel implants that may have mechanical properties which
approximate those of the natural nucleus pulposus, and to implant
such hydrogel prostheses into the central region of an
intervertebral disc, i.e., into the cavity normally occupied by the
nucleus pulposus.
SUMMARY OF THE INVENTION
[0008] According to the invention, a nucleus pulposus of an
intervertebral disc is supplemented or replaced by introducing into
the central region of an annulus fibrosus a quantity of a
biocompatible, physiologically fully hydrated hydrogel in the form
of an elongated solid hydrogel body.
[0009] Accordingly, one aspect of the invention to provide a method
of replacing or supplementing a nucleus pulposus of an
intervertebral disc.
[0010] A further aspect of the invention is to supplement or
replace a nucleus pulposus by introducing a substantially fully
physiologically hydrated hydrogel into the central region of an
intervertebral disc.
[0011] A further aspect of the invention is to introduce such a
hydrogel into the central region of an intervertebral disc, wherein
the hydrogel is introduced in the form of an elongated solid body
having a ratio of length to maximum transverse dimension of not
less than about 5:1.
[0012] A further aspect of the invention is to provide a nucleus
pulposus prosthesis that utilizes a physiologically fully hydrated
hydrogel that is compatible in terms of the equilibrium water
exchange, e.g., isotonic or iso-osmotic" with the local tissues,
i.e., nucleus pulposus and annulus fibrosus.
[0013] A further aspect of the invention is to provide a nucleus
pulposus prosthesis wherein the hydration level is substantially
independent of the applied loads encountered in the normal
physiological load bearing of the intervertebral disc (i.e, about
150N to about 1500N), thereby providing a constant volume of
hydrated hydrogel in situ.
[0014] A further aspect of the invention is to provide a
physiologically substantially fully hydrated hydrogel that provides
the clinician with improved control over implantation intra
operatively.
[0015] Further aspects of the invention will become apparent from
the description of the invention which follows and the accompanying
drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] FIG. 1 is a schematic illustration of a portion of the human
spinal column.
[0017] FIG. 2 schematically illustrates a first stage of
implantation of a hydrogel material into a nucleus pulposus cavity
according to the method of the invention, wherein a cannula through
which the prosthesis is to be implanted has been inserted through
the annulus fibrosus of the intervertebral disc.
[0018] FIG. 3 schematically illustrates a second stage of the
implantation, wherein extrusion of the hydrogel implant through the
cannula into the cavity has begun.
[0019] FIG. 4 schematically illustrates a third stage of the
implantation wherein extrusion of the hydrogel implant
continues.
[0020] FIG. 5 schematically illustrates the final stage of the
implantation wherein the cavity is substantially filled with
hydrogel.
[0021] FIG. 6 illustrates an elongated generally cylindrical
embodiment of the hydrogel implant of the invention.
[0022] FIG. 7 illustrates a flare-ended embodiment of a hydrogel
implant according to the invention.
[0023] FIG. 8 illustrates a ball-ended embodiment of a hydrogel
implant according to the invention.
[0024] FIG. 9 illustrates an embodiment of the hydrogel prosthesis
used in the method of the invention, wherein the prosthesis
comprises an elongated structure having expanded portions in the
form of beads positioned at intervals along the length of the
prosthesis.
[0025] FIG. 10 illustrates an embodiment of the hydrogel implant
according to the invention, wherein the prosthesis has directional
barbs positioned along the length of the prosthesis.
[0026] FIG. 11 illustrates an instrument for inserting an elongated
hydrogel prosthesis according to the invention through an annulus
fibrosus and into the central cavity of an intervertebral disc.
[0027] FIG. 12 illustrates the results of a representative test of
the tensile properties of the hydrogel of the invention.
[0028] FIG. 13 illustrates the results of a representative test of
the compression properties of the hydrogel of the invention.
[0029] FIG. 14 illustrates the results of a representative test of
the stress relaxation properties of the hydrogel of the
invention.
[0030] FIG. 15 illustrates the fatigue testing conditions for the
hydrogel of the invention.
[0031] FIG. 16 illustrates the results of mechanical measurements
on a spinal motion segment having a hydrogel implant according to
the invention.
DETAILED DESCRIPTION OF THE INVENTION
[0032] It is generally recognized that the volume of the normal
human nucleus pulposus is about 5 cubic centimeters (cc). However,
exact measurement is difficult, since the interface between the
nucleus and surrounding annulus is frequently indistinct,
particularly in more elderly patients. Although not normally
measured, a typical nuclectomy procedure (often called a
discectomy) involves the removal of between 0.1 and 2 cc of
nucleus. The concept of nucleus replacement therefore contemplates
insertion of a similar quantity of polymeric material in order to
fully restore the normal function of the disc.
[0033] The present invention provides for replacing the amount of
nucleus removed in a nuclectomy procedure, or for supplementing a
nucleus pulposus that has become degenerated by reason of age,
injury, or the like, with a relatively low-modulus hydrogel
polymer. According to the invention, an implant which is relatively
long and thin is inserted into the central cavity of an
intervertebral disc through a narrow cannula. The prosthesis may be
inserted through the annulus fibrosus or through the adjacent
vertebral body and vertebral endplate. After entering the nucleus
cavity, the thin implant may bend, fold upon itself, and become
entangled so that it becomes compacted and acts like a single
monolithic structure. While this method is suitable for most
hydrogel materials, the present invention is primarily intended to
employ high water content, low modulus (<4 MPa) polymers, since
such polymers tend to conform readily to surrounding containing
structures and therefore provide for an efficient and conforming
filling of a nucleus cavity.
[0034] The present invention makes use of a hydrogel, preferably
osmotically balanced (isotonic) with respect to the tissues in the
intervertebral disc with which it comes into contact. Such a
hydrogel will not take up water from nor release water into the
surrounding tissue in any substantial amount and shall thus be
referred to herein as a "physiologically fully hydrated hydrogel".
Such a hydrogel will retain the degree of hydration that it had
when implanted, and a prosthesis made from such a hydrogel will not
experience any substantial change in its mechanical properties due
to a change in degree of hydration after it has been implanted.
Consequently, when a such a hydrogel in the form of an elongated
relatively narrow body or string according to the invention is
implanted by the procedure described herein, it will incrementally
fill the available space in the nucleus pulposus cavity of an
intervertebral disc until an amount has been implanted that will
restore as much as possible the original natural function of the
intervertebral disc, and, will not thereafter experience changes in
mechanical properties. Such a hydrogel is typically relatively
soft, i.e. has a relatively low modulus, and is therefore well
adapted to conform to the cavity into which it is inserted and
thereby pack and fill the cavity. Thus, complete filling of the
cavity is achieved through essentially mechanical procedures at the
time of implantation.
[0035] Additionally, the present invention reduces the risk of
subsequent expulsion of the implant through either the hole in the
annulus fibrosus or another hole or defect in the annulus fibrosus
by providing certain embodiments of the implant provided with
terminal portions having a cross-sectional area substantially
larger than that of the main body of the implant. Alternatively or
additionally, the implant may have such expanded portions located
between the ends of the implant. Such a design provides additional
security against expulsion of the implant out of the nucleus
pulposus cavity.
[0036] The hydrated hydrogel may be inserted into a cavity formed
within the central region of the annulus fibrosus by total or
partial removal of the natural nucleus pulposus. Alternatively, the
hydrogel material may be inserted into the nuclear cavity of an
annulus fibrosus wherein no natural or artificial cavity has been
created in order to supplement the natural nucleus pulposus in a
patient whose natural nucleus pulposus has become degenerated or
has at least partially escaped through a herniation or rupture in
the annulus fibrosus. It is also according to the invention to
introduce into the nuclear cavity of the annulus fibrosus, prior to
insertion of the hydrogel material, a flexible containment vessel,
bag, envelope, container, or the like, into which the hydrogel
material is subsequently inserted. In this embodiment, the bag or
container serves as an additional means for containing the hydrogel
material within the nuclear cavity of the annulus fibrosus and
preventing subsequent expulsion.
[0037] The hydro gels suitable for use in the method of the
invention include any biocompatible hydrogel having an appropriate
modulus as indicated above. Such hydrogels are well-known to those
skilled in the art, and an appropriate hydrogel may be readily
selected from among known hydrogels. Typical hydrogels suitable for
use in the invention include copolymers of polyvinyl alcohol (PVA)
and poly (vinylpyrrolidone) (PVP), copolymers of methyl
methacrylate and vinyl pyrrolidone, poly (N-isopropylacrylamide)
(PNIPAArn), and the like. Certain hydrogels are disclosed in U.S.
Pat. No. 5,976,186 (Bao); U.S. Pat. No. 6,280,475 (Bao); U.S. Pat.
No. 6,264,695 (Stoy); U.S. Pat. No. 6,620,196 (Trieu); European
Patent EP1229873, and U.S. Patent Application No. among others, the
entire disclosure of each of which is incorporated herein by
reference.
[0038] The solid, physiologically fully hydrated hydrogel is, as
indicated above, preferably osmotically balanced with respect to
the surrounding tissues in the intervertebral disc. Such tissues
are generally in osmotic equilibrium with the surrounding
physiological fluids and may therefore be described as generally
exhibiting an osmotic pressure equivalent to that of ordinary
physiological fluids, i.e., being isotonic with respect to the
surrounding physiological fluid. The hydrogel prosthesis is
equilibrated with an isotonic solution before implantation, thereby
achieving physiological full hydration as described above.
Typically, the physiological fluids in the intervertebral space
exhibit an osmotic pressure in the range of 0.1 to 0.3 megapascals
under normal, moderate physical activity. The prosthesis is
therefore preferably equilibrated with a solution having an osmotic
pressure substantially within that range, e.g., about 0.2
megapascals. Any conventional biocompatible solution can be used. A
preferable equilibrating medium is a substantially isotonic aqueous
solution. Such solutions are well-known to those skilled in the
art, and have an osmotic pressure substantially equal to that of
the physiological fluids of the human body. Such an isotonic
aqueous solution may contain any conventional solute that is
compatible with the subsequent implantation of the prosthesis. A
preferred solute is a relatively high molecular weight polymer that
will not itself penetrate into the prosthesis in any substantial
amount. Such water-soluble polymers as poly(ethylene glycol),
dextran, and the like, are suitable solutes for preparation of the
substantially isotonic aqueous solution used to equilibrate the
hydrogel prosthesis. The formulation and preparation of isotonic
aqueous solutions is well-known to those skilled in the art.
[0039] Accordingly, the invention contemplates a method of
hydrating a hydrogel, comprising contacting said hydrogel with a
substantially isotonic solution for a period of time sufficient to
achieve a desired level of hydration, in particular an equilibrium
level of hydration. The contact is preferably accomplished by
immersing the hydrogel in the substantially isotonic solution. In a
preferred method of hydrating a hydrogel according to the invention
the substantially isotonic solution is an isotonic aqueous solution
of dextran. Thus, the invention contemplates making as prosthesis
by providing a biocompatible hydrogel in a form suitable for use as
a prosthesis, and hydrating the hydrogel in accordance with the
method of the invention described above, as well as a prosthesis so
prepared.
[0040] The solid, substantially fully hydrated hydrogel is
introduced into the central cavity of an annulus fibrosus in the
form of a generally elongated solid body having a dimensional ratio
of its length to its principal diameter or transverse dimension,
i.e., a dimension generally at right angles to the length or
longest dimension, of at least about 5:1. Preferably the
dimensional ratio of length to principal transverse dimension is at
least about 10:1, more preferably about 50:1, still more preferably
at least about 100:1, and still more preferably at least about
500:1. The dimensional ratio of longest dimension to principal
transverse dimension may be as great as 1000:1 or greater. A
particularly preferred dimensional ratio of length to principal
transverse dimension is about 350:1.
[0041] The hydrogel used in the method of the present invention
will typically have an elastic modulus not greater than about 4
MPa. Typically, the elastic modulus of the fully saturated hydrogel
will be between about 0.05 MPa and 4.0 MPa. Preferably, the elastic
modulus and transverse dimension will be chosen such that the
hydrogel body can fold easily upon insertion into the central
cavity of the annulus in order to fill substantially the entire
volume of the cavity. Accordingly, the elongated hydrogel body will
typically have a principal transverse dimension not greater than
about 10 mm, preferably not greater than about 5 mm and more
preferably not greater than about 2.5 mm. The principal transverse
dimension of the elongated body is not subject to any strict
minimum. It may be chosen, for example, to provide a suitable
folding pattern within the central cavity of the annulus fibrosus,
to provide a suitable amount of hydrogel material within a
convenient length, or for other reasons relevant to the
implantation method of the invention. Typically, the principal
transverse dimension of the hydrogel body will be at least about
0.5 mm or greater.
[0042] The length and transverse dimensions of the hydrogel body to
be inserted into the nucleus pulposus cavity of the annulus
fibrosus will be determined by the total volume of hydrogel
material to be inserted into the cavity. Accordingly, the skilled
practitioner can readily determine an appropriate length and
transverse dimensions in a particular situation.
[0043] The transverse cross-section of the elongated hydrogel body
may be any convenient shape. For example, the elongated hydrogel
body may have a generally circular, elliptical, square,
rectangular, crescent-shaped, or other transverse cross-sectional
shape as may be convenient for insertion through a given aperture
or required by the need to fold within a cavity of a particular
size or shape.
[0044] The hydrogel body to be inserted into the nucleus pulposus
cavity of the intervertebral disc may also be provided with a
portion of larger transverse cross-section at one or both ends
thereof, in order to prevent expulsion of the hydrogel body through
the insertion aperture in the annulus fibrosus or adjacent
vertebral endplate. For example, either or both ends of the
elongated hydrogel body may be provided with a generally spherical
termination having a diameter somewhat greater than the principal
diameter, i.e. the diameter of the central or nonterminal portion
of the elongated hydrogel body. Alternatively, one or both of the
ends of the elongated hydrogel body may be provided with a flared
shape or one or more transverse or angulated cross-members, forming
aT-shape, Y-shape, X-shape, or the like. Examples of such
prostheses are illustrated in the drawings and described below. The
hydrogel body, and/or the terminal portion of greater transverse
cross-sectional area may be deformed, constricted, compressed, or
the like before insertion through the insertion cannula. After
insertion, such a deformed or compressed hydrogel body will expand
to provide a shape designed to prevent expulsion through the
insertion hole in the annulus fibrosus. The prosthesis may be
manufactured by extrusion or conventional molding procedures, such
as compression molding, injection molding, and the like.
[0045] According to the invention, a hydrogel polymer prosthesis is
provided having a generally elongated shape, preferably having a
relatively low modulus and a transverse cross-sectional profile
such that it can be compressed to be extruded through a cannula
having an inside diameter not greater than about 5 millimeters. In
certain embodiments, the insertion cannula may have an inside
diameter of 3.5 millimeters. In a preferred embodiment of the
invention, a relatively soft polymer hydrogel is provided in a long
cylindrical shape such that its diameter is not greater than about
5 mm and its length is sufficient to provide a volume of hydrogel
sufficient for replacing or supplementing a nucleus pulposus. Such
a prosthesis may have a length as long as about 300-500 mm. If the
implant is not too long for convenient manipulation, it may be
provided to surgery within a generally rigid cannula (metal or
plastic) with an outer diameter slightly larger than the diameter
of the implant. Once the nucleus cavity has been prepared to the
surgeon's satisfaction, the end of the cannula is gently inserted
through the annulus into the disc cavity. Using a rod of diameter
similar to that of the hydrogel implant, the implant is pushed out
of the cannula and fills the cavity. This is continued until either
the pressure required to continue is too high or the surgeon is
satisfied that sufficient hydrogel has been inserted. At this
point, the implant is cut to length and the cut end pushed into the
nucleus cavity. Alternatively, the implant may be provided in a
separate storage tube, which can be somewhat flexible for
convenient manipulation. Such a storage tube may then be coupled to
a rigid cannula that is inserted or to be inserted through the
annulus fibrosus as described above. In this embodiment a source of
fluid pressure may be coupled to the distal end of the storage tube
in order to extrude the implant thorough the insertion cannula and
into the nucleus pulposus region of the intervertebral disc. When a
sufficient amount of the implant has been inserted, the implant may
be cut to length and the remainder pushed into the nucleus cavity
as described above. In either procedure, the implant may also be
severed within the nucleus pulposus region using an insertion
cannula provided with an appropriate cutter. An example of such an
insertion cannula is described below.
[0046] An exemplary method of implantation of a physiologically
fully hydrated hydrogel according to the invention is illustrated
schematically in FIGS. 1-5.
[0047] FIG. 1 illustrates a left lateral schematic view of the
lumbar portion of a human spine 100, showing the general
configuration of the vertebrae 102 and intervertebral discs 104.
Although the invention will be described with respect to a lumbar
intervertebral disc, a skilled practitioner will understand that it
may be practiced with respect to any of the intervertebral discs
that have a similar structure, with appropriate modifications as
may be required.
[0048] The implantation of a hydrogel prosthesis of the invention
is illustrated in FIGS. 2-5, wherein the procedure is viewed from a
superior view of a typical intervertebral disc as indicated by the
line 2-2 in FIG. 1.
[0049] FIG. 2 shows the initial step in the implantation of a
hydrogel prosthesis of the invention wherein a cannula 202 has been
inserted though the annulus fibrosus 106 of an intervertebral disc
104 and into the nucleus pulposus cavity 108. The nucleus pulposus
cavity 108 may be in need of a prosthesis by reason of natural
degeneration or leakage of the nucleus pulposus or after partial or
total removal of the natural nucleus pulposus. The cannula 102 may
be any type of conventional cannula, including a cannula having a
sharp point as illustrated or a blunt point, inserted through the
annulus fibrosus 106 by any conventional surgical technique. The
cannula 202 is shown partly cut away to show a prosthesis of the
invention 302 loaded within the cannula 202.
[0050] The length of the prosthesis will depend on the amount of
hydrogel to be implanted, which in turn is dictated by the vacant
volume in the nucleus pulpous cavity as may be determined by
conventional means. The length may be readily calculated from the
cylindrical or other geometry of the prosthesis once the amount
needed to fill the void space in the nucleus pulposus cavity, or to
supplement the nucleus pulposus, has been determined.
Alternatively, the prosthesis may be extruded into the cavity of
the nucleus pulposus until the internal pressure reaches a value
sufficient to restore, at least partially, the function of the
intact nucleus pulposus.
[0051] The force required to extrude the hydrogel prosthesis in to
the nucleus pulposus cavity may be supplied by any conventional
means. If the amount of hydrogel to be implanted is relatively
small, it may be contained in the rigid extrusion cannula and
forced into the nucleus pulpous cavity with a stiff rod.
Alternatively, a syringe or pump connected directly or indirectly
to the external end of the implantation cannula may be used. If the
amount of hydrogel to be implanted exceeds that which can be
conveniently contained in a rigid implantation cannula, it may be
supplied in a tube of appropriate size that is coupled to the
external end of the implantation cannula and forced from the supply
tube through the implantation cannula by any conventional means,
such as described above.
[0052] FIG. 3 shows an initial stage of the implantation wherein
the extrusion of the implant from the cannula into the nucleus
pulposus cavity has begun. FIG. 4 illustrates an intermediate stage
in the implantation of the prosthesis wherein the prosthesis has
begun to fill any vacant volume within the nucleus pulposus cavity
and is folded upon itself as required to fit into the cavity. FIG.
5 illustrates the final stage of implantation wherein the
prosthesis has substantially filled any vacant volume in the
nucleus pulposus cavity and is preferably packed therein with
sufficient pressure to approximate the pressure of the natural
nucleus pulposus.
[0053] After the requisite amount of the hydrogel prosthesis has
been extruded into the nucleus pulposus cavity, the terminal end is
pushed into the cavity, for example by a rod passed through the
cannula. Preferably, the terminal end of the prosthesis is moved to
a position as far as readily possible from the hole through which
the prosthesis was introduced. This procedure minimizes the
possibility that an end of the prosthesis might find the hole and
be expelled therethrough by the pressure present within the filled
nucleus pulposus cavity.
[0054] In an alternative method of implanting the hydrogel
prosthesis of the invention, the implant can be introduced into the
nucleus cavity by passage through either the superior or inferior
vertebral body. This approach has the advantage of not requiring
any surgical procedure with respect to the annulus fibrosus,
although it does require making an access aperture in the vertebral
endplate. In this embodiment also, the relatively small diameter of
the hydrogel prosthesis makes it possible to use a relatively small
aperture in the vertebral endplate.
[0055] FIG. 6 schematically illustrates a generally cylindrical
prosthesis 302 as used in the method illustrated in FIGS. 2-5,
having a principal diameter dl typically not greater than about 5
millimeters. The length of such a prosthesis may vary, as indicated
above, depending on the volume of hydrogel to be implanted into the
nucleus pulposus cavity.
[0056] In order to decrease the probability that the hydrogel
prosthesis of the invention will be expelled from the central
region of the annulus fibrosus through the hole through which it
was implanted, at least one portion, i.e., a portion of the length
of the prosthesis, may have a cross-sectional area greater than
that of another segment of the prosthesis. In particular, either or
both ends of the prosthesis may be terminated in expanded portions,
i.e., having a cross-sectional area greater than that of the
central or non-terminal portion of the implant (principal
cross-sectional area), as illustrated, e.g., in FIGS. 7 and 8, in
order to reduce the probability of the prosthesis being expelled
through the hole in the annulus fibrosus through which it was
implanted. The end is typically compressed when the implant is
inserted into the nuclear cavity in the annulus fibrosus and
expands once inside the cavity.
[0057] Accordingly, FIG. 7 illustrates an alternative embodiment
402 of the prosthesis of the invention having a principal diameter
d2 and a flared end 404 of greater diameter. Either end or both
ends of the prosthesis may be flared in order to reduce the
possibility of the prosthesis being expelled through the insertion
hole made in the annulus fibrosus. The flared end 404 may be
segmented circumferentially, as by the provision of
circumferentially spaced cutouts 406, to facilitate deformation of
the end for insertion into the nucleus pulposus cavity.
[0058] FIG. 8 illustrates another embodiment 502 of the prosthesis
of the invention having a principal diameter d3 , wherein the
elongated prosthesis is terminated with a generally spherical ball
504. Either or both ends of the prosthesis 502 may be terminated
with a ball. The skilled practitioner will recognize that numerous
alternative designs of expanded end portions of the prosthesis of
the invention incorporating the same principle are possible.
[0059] In another embodiment of the prosthesis of the invention,
the implant has one or more repeating structures having at least
one transverse dimension greater than a principal transverse
dimension (diameter d4) of the prosthesis. Such structures will
have a cross-sectional area greater than that of the adjacent
portions of the prosthesis. Preferably, at least one transverse
dimension of such an expanded portion is greater than--the diameter
of the hole in the annulus fibrosus through which the introduction
cannula was inserted. More preferably, the expanded portion is
generally symmetrical about the axis of the prosthesis and has a
transverse diameter greater than the diameter of the hole in the
annulus fibrosus through which the introduction cannula is
inserted. Two examples of such prostheses are illustrated in FIGS.
9 and 10. The skilled practitioner will recognize that numerous
alternative designs incorporating the same principle are
possible.
[0060] FIG. 9 shows a prosthesis 602 of principal diameter d4
having a number of generally spherical expanded portions (beads)
604 spaced along the prosthesis. The beads are typically compressed
when the implant is inserted into the nuclear cavity in the annulus
fibrosus and expand once the prosthesis has been inserted into the
nucleus pulposus cavity.
[0061] FIG. 10 shows a prosthesis 702 of principal diameter or
cross-dimension d5 having a number of barb-like projections 704
spaced along the prosthesis. The barbs may be located substantially
contiguously along the body of the hydrogel prosthesis, or they may
be spaced along the body of the prosthesis somewhat like the
spherical expanded portions of the prosthesis illustrated in FIG.
9. The barbs are typically compressed when the implant is inserted
into the nuclear cavity in the annulus fibrosus and expand once the
prosthesis has been inserted into the nucleus pulposus cavity.
[0062] A suitable insertion instrument for inserting the hydrogel
prosthesis of the invention into a nucleus pulpous cavity is
illustrated in FIG. 11. The instrument 800 of FIG. 11 comprises a
generally straight cannula portion 802, a funnel portion 804 and a
coupling 806. In use, a prosthesis of the invention that is to be
inserted in compressed form, e.g., a beaded prosthesis, such as
illustrated in FIG. 9, is supplied contained within a tubular
supply conduit which is coupled to the insertion instrument 800 via
the coupling 806. The prosthesis is then forced from the supply
conduit through the funnel portion 804 and through the straight
portion 802 into the nucleus pulposus cavity. The insertion
instrument 800 is also provided with a cutting wire loop 808 which
is led through an auxiliary tube 810 attached to the straight
portion 802 of the insertion instrument 800 to a handle or ring
812. When a sufficient amount of the hydrogel has been inserted
into the nucleus cavity, the hydrogel can be severed inside the
cavity by pulling on the handle 812, whereby the cutting loop 808
is tightened and cuts the prosthesis. The insertion instrument 800
is then withdrawn to complete the surgical implantation
procedure.
[0063] Insertion of a compressible prosthesis using the insertion
instrument 800 allows the implant to be inserted through a cannula
which minimizes the hole in the annulus fibrosus, thus minimizing
the trauma to the annulus, and also provides that the diameter of
any passageway left in the annulus after the insertion cannula is
withdrawn will be smaller than the diameter of the prosthesis that
has been inserted. Such a minimized passageway will provide a
further barrier to any possible expulsion of the prosthesis. The
skilled practitioner will recognize that numerous alternative
designs of an insertion cannula incorporating the same principle
are possible.
[0064] The practice of the invention will be illustrated by the
following nonlimiting examples.
EXAMPLE 1
[0065] This example illustrates the preparation of a preferred
hydrogel used in the practice of the invention.
[0066] An amount of 12.7 g of PVA (Mowiol, supplied by Kuraray Co.
Ltd., 132,000 M.sub.w 50,000 M.sub.n P.sub.D 2.6; >99.1%
hydrolyzed) is mixed with 0.127 g of PVP (Plasdone, supplied by
International Specialty Products, 58,000 M.sub.w), 6.5 g of
BaSO.sub.4 and 81 mL of water. The solution is heated at 95.degree.
C. for 10 hrs and then placed into a mold. The mixture contained in
the mold is then placed in a programmable environmental chamber and
subjected to six successive freeze-thaw cycles ranging from
+30.degree. C. to -30.degree. C. for 21 hours and 3 hours
respectively. The gel so formed is then demolded and placed in a
substantially isotonic osmotic aqueous solution of dextran for one
day to osmotically balance the water content of the gel to a state
similar to that of the human nucleus pulposus. Finally the
prosthesis is packaged and sent for sterilization.
EXAMPLE 2
[0067] This example illustrates the basic mechanical properties of
a hydrogel as prepared in Example 1.
[0068] Hydrogels often exhibit nonlinear mechanical properties and
are highly deformable materials, and thus their properties are
highly dependent on the testing and test conditions. A preferred
hydrogel used in the invention was tested in the following manner
to obtain the material incremental modulus. Tensile and compression
properties were obtained as follows using a conventional mechanical
testing machine.
[0069] A tensile test is performed on a sample 3.8 mm in diameter
and 100 mm in length of a hydrogel prepared as in Example 1. The
sample is gripped on both ends such that a 60 mm hydrogel gauge
length exists between each grip. A preload of 0.04N is applied to
the specimen. A tensile test is then performed on the specimen at a
rate of 60 mm/min. The incremental tensile modulus is calculated as
the slope of the line passing through points corresponding to the
representative strain level. FIG. 12 shows the output of a
representative tensile test. A typical tensile modulus value of the
preferred embodiment, tested as indicated above, is 0.675 MPa @ 50%
strain.
[0070] A compression test is performed on a sample 12.0 mm in
diameter and 8 mm in height of a hydrogel prepared as in Example 1.
The sample is placed in a bath of a substantially iso-osmotic
solution, e.g., a substantially isotonic aqueous solution of
dextran, at 37.degree. C. for testing. A compressive preload of IN
is applied to the specimen. A compression test is then performed on
the specimen at a rate of 100% of test specimen height/min. The
incremental compressive modulus is calculated as the slope of the
line passing through points corresponding to the representative
strain level. A plot of a typical compression test is presented in
FIG. 13. A typical compressive modulus value of a preferred fully
hydrated hydrogel of the invention is 0.984 MPa@15% strain.
EXAMPLE 3
[0071] This example illustrates the maintenance of the water
content of the fully hydrated hydrogel of the invention under
certain conditions of loading.
Stress Relaxation:
[0072] A 12 mm diameter material test specimen 8 mm in height is
placed in a 37.degree. C. bath of an isotonic aqueous solution. A
stress relaxation study is performed on the specimen consisting of
15% displacement for 16 hours followed by 8 hours of unloaded
recovery. The sample is tested through three successive cycles.
Mass and modulus values are calculated before and after the
three-cycle test. A plot of the conditions imposed in a typical
testing cycle is presented in FIG. 14. The embodiment of the fully
hydrated hydrogel as prepared in Example 1 shows less than 5%
change in mass, modulus, and water content under this stress
relaxation protocol.
Fatigue:
[0073] A fatigue study is performed to test for changes in water
content under physiologic loading in the following manner. A 12 mm
diameter test specimen 8 mm in height is weighed measured and
tested to determine compressive incremental modulus values. The
sample is placed in a bath of an isotonic aqueous solution at
37.degree. C. and then cycled through 0-15% displacement for 1
million cycles at a frequency of 5 Hz, as shown in FIG. 15. After
cyclic testing, the test specimen is again weighed, measured, and
incremental modulus value calculated. The embodiment of the fully
hydrated hydrogel as prepared in Example 1 shows less than 5%
change in mass, modulus, and water content under this fatigue
protocol.
EXAMPLE 4
[0074] This example illustrates restoration of the mechanical
properties of a spinal motion segment using a physiologically fully
hydrated hydrogel prosthesis in accordance with the invention.
[0075] A flexibility experiment was conducted by performing the
process of the invention for replacing the nucleus pulposus, and
measuring the flexibility of the intervertebral unit at various
steps to simulate the degeneration and restoration of the nucleus.
An appropriate specimen of an L4/L5 spinal motion segment was
selected, including the L4 and L5 lumbar vertebrae and the
intervertebral disc therebetween with intact annulus fibrosus and
nucleus pulposus. The selected specimen had an essentially normal
nucleus pulposus. The specimen was subjected to measurement of
flexibility at four stages before, during and after the nucleus
replacement procedure by conducting a simulated flexion-extension
series using pure moments. The torque required for a range of
defined angles of flexion and extension was applied. The results
are presented in the chart in FIG. 16.
[0076] The first of the four flexion-extension series was conducted
on the intact healthy disc; the results are shown in Curve 1. The
nucleus was then removed and the specimen was tested through the
same applied moments as shown in Curve 2. Accordingly, the second
series simulates a severely degraded nucleus. The specimen was then
implanted with a physiologically fully hydrated hydrogel implant of
the invention, equilibrated using an isotonic saline solution, that
partially filled the core and was tested again, thereby simulating
a somewhat degenerated nucleus or a nucleus replaced without
pressurization. The implant comprised a physiologically fully
hydrated hydrogel having a diameter of about 3 mm and was inserted
through the vertebral endplate. A length of about 120 mm of implant
was used. A movement towards normal physiologic values over the
range of motion was found, shown in Curve 3. Finally, when the
specimen was implanted with a physiologically hydrated hydrogel
implant of the invention (about 3 diameter and about 120 mm in
length) and the core was completely filled and pressurized, using
the technique described above, close to full restoration of the
disc mechanics was found, as shown in Curve 4.
[0077] The method of the invention using the physiologically fully
hydrated hydrogel of the invention provides the clinician with a
number of advantages. The amount of hydrogel to be implanted can be
predetermined and in order to achieve a desired volume of implant
with a resulting stable dimension of the implant. The method of
implantation provides appropriate feedback through direct
monitoring of the pain response of the patient to avoid
overpressurization of the disc nucleus cavity or to detect a
situation wherein the intervertebral disc is chemically sensitive.
Furthermore, by using an embodiment of the physiologically
substantially fully hydrated hydrogel containing a radiopaque
material, e.g., BaSO.sub.4, it is possible to monitor the
implantation through interactive radiographic and/or fluoroscopic
visualization.
[0078] The method of the invention using a physiologically fully
hydrated hydrogel also provides flexibility in the surgical
intervention by reason of its ability to readily accommodate
variations in anatomy of a patient and variations in the size
and/or shape of the intervertebral disc cavity due to varied
effectiveness in nucleus removal. It provides the option of full
nucleus replacement or partial nucleus replacement (through partial
removal of the nucleus), or augmentation of the nucleus by simply
adding implant without previously removing nucleus material.
[0079] The prosthesis and method of the invention are well adapted:
[0080] to fill variably-shaped nucleus cavities; [0081] to provide
for volumetric filling without requiring a large entrance or
insertion opening into the nucleus cavity; [0082] to provide for
varied volumetric filling by allowing for arbitrarily variable
lengths of polymer to be inserted; [0083] to minimize the
possibility of subsequent implant expulsion by providing a
relatively small cross-sectional area of the insertion opening and
minimizing probability that the end of the implant could be
positioned at the insertion opening in the annulus fibrosis and
thereby escape from the pulposus cavity through the insertion
opening.
[0084] The invention having been described in the foregoing, it
will be apparent to those skilled in the art that many variations
and/or changes can be made therein without departing from the
nature and spirit of the invention, and all such changes and/or
variations are intended to be included within the scope of the
invention.
* * * * *