Abstract:
The present application is directed to transformable implants for a variety of medical applications. The implants transform from a malleable pre-filled article into a more rigid device via hardening of the implant material. The malleable aspects of the implants facilitate delivery and insertion for implantation in a minimally invasive procedure. The hardened implants provide for load-bearing that maximizes in vivo performance. Activation for hardening the implant material may be accomplished by various means, and may occur prior to insertion into the patient, during insertion into the patient, or after insertion into the patient.

Description:
BACKGROUND  
       [0001]     The present application is directed to implants and methods for a variety of medical applications and, more specifically, to implants that transform from a malleable state for insertion and positioning within a patient to a hardened load bearing state after being positioned within the patient.  
         [0002]     There are numerous devices and methods for inserting an implant within a patient to support a vertebral member. Many of these generally involve invasive surgery that requires resecting tissue in order to gain access to the injury site. This may include the need to cut through skin, nerves, vessels, muscles, ligaments, and/or tendons. These procedures may also require longer surgical procedures that use general or spinal anesthesia, and blood transfusions.  
         [0003]     Invasive surgery may also result in a longer hospitalization period that is necessary for the patient to recover. During this time, the patient may have post-surgical pain and discomfort. Further, there may be a need for significant recovery time that requires physical therapy. Inherent with this amount of additional care is the increased costs associated therewith.  
       SUMMARY  
       [0004]     The present application is directed to implants and methods of use for supporting one or more vertebral members. The implant may include a flexible shell that contains a precursor material. In an initial state, the material and shell may be malleable for insertion into the patient. The precursor material may be activated and begin to cure to a hardened state. The hardening may occur by polymerization, crosslinking, complexation, or gelation. The implant may be inserted into the patient while still in a malleable state. The implant is positioned within the patient and cures to a hardened load-bearing state to support one or more of the vertebral members. The activation of the precursor material may occur prior to insertion into the patient, during insertion into the patient, or after insertion into the patient. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]      FIG. 1A  is a top schematic view illustrating an implant according to one embodiment.  
         [0006]      FIG. 1B  is a top schematic view illustrating an implant according to one embodiment.  
         [0007]      FIG. 1C  is a top schematic view illustrating an implant being inserted into an annulus fibrosis according to one embodiment.  
         [0008]      FIG. 1D  is a top schematic view illustrating an implant positioned within an interior disc space according to one embodiment.  
         [0009]      FIG. 1E  is a top schematic view illustrating an implant positioned within an interior disc space according to one embodiment.  
         [0010]      FIG. 2  is a side schematic view illustrating an implant according to one embodiment.  
         [0011]      FIG. 3  is a side schematic view illustrating an implant according to one embodiment.  
         [0012]      FIG. 4  is a side schematic view illustrating an implant according to one embodiment.  
         [0013]      FIG. 5  is a side schematic view illustrating an implant according to one embodiment.  
         [0014]      FIG. 6  is a side schematic view illustrating an implant and a syringe according to one embodiment.  
         [0015]      FIG. 7  is a side schematic view illustrating an implant and a syringe according to one embodiment.  
         [0016]      FIG. 8  is a perspective view illustrating an implant according to one embodiment.  
         [0017]      FIG. 9  is a schematic view illustrating an implant according to one embodiment.  
         [0018]      FIG. 10  is a schematic view illustrating an implant according to one embodiment.  
         [0019]      FIG. 11  is a schematic view illustrating an implant according to one embodiment.  
         [0020]      FIG. 12  is a perspective view illustrating an implant according to one embodiment.  
         [0021]      FIG. 13  is a perspective view illustrating an implant according to one embodiment.  
         [0022]      FIG. 14  is a top schematic view illustrating an implant according to one embodiment.  
         [0023]      FIG. 15  is a perspective view illustrating an implant according to one embodiment.  
         [0024]      FIG. 16  is a perspective view illustrating an implant according to one embodiment.  
         [0025]      FIG. 17  is a perspective view illustrating an implant according to one embodiment.  
         [0026]      FIG. 18  is a perspective view illustrating an implant according to one embodiment.  
         [0027]      FIG. 19  is a perspective view illustrating an implant according to one embodiment.  
         [0028]      FIG. 20  is a perspective view illustrating an implant according to one embodiment.  
         [0029]      FIG. 21A  is a side schematic view illustrating an implant being inserted into a patient according to one embodiment.  
         [0030]      FIG. 21B  is a side schematic view illustrating an implant being inserted into a patient according to one embodiment.  
         [0031]      FIG. 22  is a perspective view illustrating an implant according to one embodiment.  
         [0032]      FIG. 23  is a perspective view illustrating an implant according to one embodiment.  
         [0033]      FIGS. 24A and 24B  are side schematic views illustrating an implant being inserted into a patient according to one embodiment.  
         [0034]      FIG. 25  is a perspective view illustrating an implant according to one embodiment.  
         [0035]      FIG. 26  is a perspective view illustrating an implant according to one embodiment.  
         [0036]      FIG. 27  is a perspective view illustrating a cannula according to one embodiment.  
         [0037]      FIG. 28  is a side schematic view illustrating a plunger according to one embodiment.  
         [0038]      FIGS. 29A and 29B  illustrate one embodiment of a cannula in first and second positions according to one embodiment.  
         [0039]      FIGS. 30A and 30B  illustrate one embodiment of a cannula in first and second positions according to one embodiment. 
     
    
     DETAILED DESCRIPTION  
       [0040]     The present application is directed to transformable implants for a variety of medical applications. In one embodiment, the implants include a shell that contains one or more precursor materials. The shell may be constructed of a flexible material and the one or more precursor materials that are flowable resulting in the implant being malleable for implanting into the patient.  
         [0041]     The precursor materials undergo an activation process that starts the transformation to a hardened state. The activation process may include chemical reaction, thermal reaction, photo reaction such as visible, ultra-violet, or infrared light, radiation, electrical and physical reactions. The activation process may begin prior to insertion of the implant into the patient, during the insertion, or after insertion.  
         [0042]     The transformation of the precursor material or materials to the hardened state may occur through crosslinking, polymerization, gelation, complexation, and others. The transformation causes the implant to change from a malleable device that facilitates insertion and positioning with the patient, to a rigid or semi-rigid load bearing device. The term “hardened” and the like refers to materials and combination of materials that can solidify, in situ, at the tissue site, in order to retain a desired load bearing position and configuration.  
         [0043]     The implants may be applicable to a variety of medical operations. One application includes an intervertebral device such as a nucleus replacement, disc replacement, or fusion device. A vertebral rod or plate that extends along one or more vertebral members is another application. The implants may also be used for an interspinous spacer.  
         [0044]      FIGS. 1A-1E  illustrates one method of implementation of an implant  20 .  FIG. 1A  illustrates the implant  20  including a shell  21  and seals  22  that physically divide the shell  21  into first and second chambers  23 ,  24  that are physically isolated. A first precursor material is contained within the first chamber  23  and segregated from a second material that is contained in the second chamber  24 . The seals  22  physically segregate the precursor materials and prevent activation. The shell  21  is constructed of a flexible material and may have a predefined shape, or may be amorphous. In this embodiment, shell  21  has an annular predefined shape. Prior to activation, the implant  20  is malleable and may be deformed from the predefined shape for insertion into and positioning within the patient.  
         [0045]      FIG. 1B  illustrates the seals  22  being compromised causing the materials to mix together and being the activation. One manner of compromising the seals  22  includes physically deforming the shell  21  which may build pressure within one or more of the chambers  23 ,  24  to rupture the seals  22 . The materials may mix together themselves, or mixing may be aided by deforming and kneading the shell  21  thereby forcing the materials throughout the entirety of the interior space previously formed by the two chambers  23 ,  24 .  
         [0046]     The mixed materials remain sufficiently viscous for a predetermined time after activation for the implant to remain malleable for insertion and positioning. The embodiment of  FIG. 1C  illustrates the implant  20  being inserted through the annulus fibrosis  100  and into an interior space  101  of an intervertebral disc. The malleable nature of the implant  20  upon activation allows for the shell  21  to be deformed into a reduced width for insertion through the annulus fibrosis. During the insertion process, the materials may begin to polymerize and solidify. The implant  20  remains malleable during the initial polymerization and solidification.  
         [0047]     After insertion through the annulus fibrosis  100 , the shell  21  returns towards the predefined shape which in this embodiment is an annular ring as illustrated in  FIG. 1D . The shell  20  is moved to the appropriate position within the interior space  101  as the materials continue to transform towards a hardened state. The amount of hardening increases with time as the materials transform to a lower viscosity. The materials eventually transform to a hardened load-bearing state for supporting the adjacent vertebral members. In one embodiment, the materials go through a phase transition and assume a rigid, solid state as illustrated in  FIG. 1E . In other embodiments, the materials harden to a semi-rigid state that is also able to support the vertebral members.  
         [0048]     The shell  21  may constructed of a variety of materials. Examples include but are not limited to various polymeric materials, such as aliphatic or aromatic polycarbonate-based and non-polycarbonate-based polyurethanes, polyethylene terephthalates, polyolefins, polyethylene, polycarbonate, ether-ketone polymers, polyurethanes, nylon, polyvinyl chloride, acrylic, silicone, and combinations thereof. The material comprising the shell  21  may further be reinforced with woven or non-woven textile materials. Examples of suitable reinforcement materials include those that are polymeric and metallic in nature.  
         [0049]     In one embodiment, the shell  21  is constructed from a single layer. The layer may be constructed of a common material throughout, or may be constructed of two or more different materials. Shell  21  may also be constructed of multiple layers. The entire shell  21  may include multiple layers, or a limited section may include multiple layers. In one embodiment, shell  21  includes an inner layer that is encased in fabric. In one embodiment, the shell  21  includes an insertion section that is initially inserted into the patient. By way of example and using  FIG. 1C  as an example, insertion section  25  is introduced into the patient and through the annulus fibrosis  100  prior to the remainder of the shell  21 . The insertion section  25  may be reinforced because of the extra wear. The reinforcement may include multiple layers, textile materials, and the like.  
         [0050]     A variety of different precursor materials may also be used in the various embodiments. In some embodiments, a single precursor material is positioned within the shell  21  and upon activation changes to the hardened state. In other embodiments, two or more precursor materials are activated. The precursor material or materials should be flowable and include a viscosity for the implant  20  to be malleable prior to the material reaching a predetermined hardened state. This facilitates insertion and positioning of the implant  20  within the patient in a minimally invasive manner. The material or materials should further be curable in situ, at the tissue site, to undergo a phase or chemical change sufficient to retain a desired position and shape and assume a load-bearing capacity.  
         [0051]     The precursor material and materials may range from an injectable liquid to a visco-elastic solid. In one embodiment, the material cures to a hardened state within about 2 minutes to about 6 hours after activation. In a specific embodiment, the material cures in between about 5 to about 60 minutes after activation.  
         [0052]     Material may further be homogeneous with the same chemical and physical properties throughout, or heterogeneous. A variety of materials may be used and may include silicones, polyurethanes, silicone-polyurethanes, polyvinyl chlorides, polyethylenes, styrenic resins, polypropylene, polyolefin rubber, PVA, protein polymers, thermoplastic polyesters, thermoplastic elastomers, polycarbonates, acrylonitrile-butadiene-styrene resins, acrylics, nylons, styrene acrylonitriles, cellulosics, DBM, PMMA bone cement, tissue growth factor, epoxy, calcium phosphate, calcium sulfate, and resorbable polymers such as PLA, PLDLA, and POLYNOVO materials. Various materials are disclosed in U.S. Pat. Nos. 5,888,220 and 6,428,576, and U.S. Patent Application Nos. 2004/0230309, 2004/0102774, 2006/0004456, and 2004/0133280, each of which is herein incorporated by reference in their entirety. The material may also include a pharmaceutical composition comprising one or more biological response modifiers. Examples of pharmaceutical compositions are disclosed in U.S. Patent Application No. 2006/0046961 herein incorporated by reference in its entirety. Material  25  may further include an opaque additive, such as barium sulfate, that will be visible on an X-ray.  
         [0053]     One or both of the shell  21  and material may be bioresorbable. In one embodiment, the shell  21  is a bioresorbable non-porous (sheet or film) or a bioresorbable porous (braided fibers) shell. The material is a precursor of resorbable polymer that polymerizes, cures or crosslinks in situ. The following families of resorbable polymers can be used for the shell  21  and/or the filling materials: poly(L-lactic acid), poly(D,L-lactic acid), poly(D L-lactic-co-glycolic acid), poly(glycolic acid), poly(epsilon-caprolactone), polyorthoesters, polyanhydrides, polyhydroxy acids, polydioxanones, polycarbonates, polyaminocarbonates, polyurethane, poly(ethylene glycol), poly(ethylene oxide), partially or fully hydrolyzed poly(vinyl alcohol), poly(ethylene oxide)-co-poly(propylene oxide) block copolymers (poloxamers and meroxapols), poloxamines or combinations thereof.  
         [0054]     Activation of the material or materials may occur by a variety of methods. In one embodiment, the activation may start before the implant  20  is inserted into the patient. The implant  20  is activated and during the activation is inserted and positioned within the patient while still malleable and prior to reaching the hardened state. The implant  20  may also be activated during the insertion process. The activation may occur during the deformation necessary to insert the implant  20  into the patient, such as the necessary compression during insertion through a cannula in a minimally invasive procedure. Activation may also occur after the implant  20  is inserted within the patient. In one embodiment, the implant  20  is inserted and accurately positioned prior to activating the material or materials.  
         [0055]     Activation methods may further include exposing the implant with the one or more materials  23 ,  24  to an energy source prior to insertion into the patient. The energy source may include a thermal source, such as a heat gun or autoclave chamber. The energy source may also include a radiation source such as an X-ray device or fluoroscopy arm. An electrical source may further be used such as a battery or source that emits AC or DC electrical current. Light energy including ultraviolet or infrared light sources may be used for activation. Activation in other embodiments may be caused by a physical energy source such as pressure or impact force that is applied to the implant  20 .  
         [0056]     One method of activation occurs by physically mixing two or more precursor materials that are already contained within the shell  21 .  FIG. 1B  illustrates an embodiment with the shell  21  including first and second chambers. One or more seals  22  are broken to allow the materials  23 ,  24  to physically mix together. Mixing may occur by kneading the shell  21  prior to insertion, during the compression and deformation for insertion into the patient, or after insertion.  FIG. 2  illustrates another embodiment with a single seal  22  physically separating the chambers  23 ,  24 .  FIG. 3  illustrates a first seal  22   a  that forms first and second chambers  23 ,  24  for physically separating the first and second materials. A rupture device  60  is positioned within the shell  21  to break the seal  22   a.  Rupture device  60  may include an edge  61  that is brought into contact to rupture the seal  22   a.  In one embodiment, a base  62  of the rupture device  60  is attached to the inner wall of the shell  21 . This positioning maintains the edge  61  facing outward towards an interior of the shell  21  to lessen the likelihood of inadvertently rupturing the shell  21 . The material surrounds and covers the rupture device after hardening to prevent any potential damage from occurring.  
         [0057]     The shape and sizes of the various chambers may vary depending upon the materials.  FIG. 1A  illustrates an embodiment with first and second chambers  23 ,  25  that are substantially equal in size.  FIG. 3  illustrates first and second chambers  23 ,  24  that are substantially equal. Shell  21  further includes a second seal  22   b  that forms a third chamber  25 . The third chamber  25  is considerably smaller than either of the first two chambers  23 ,  24 . In the embodiment of  FIG. 3 , the second seal  22   b  may be ruptured by a variety of manners, including physically manipulating the shell  21 .  
         [0058]     Physically separating the precursor materials may include placing one or more of the materials within a container  40  positioned within the shell  21 .  FIG. 6  illustrates an embodiment with a container  40  positioned within the shell  21 . Container  40  forms an enclosed area  26  sized to hold the second material in physical separation from the first material within the first chamber  23 . The container  40  may be statically positioned within the shell  21 , or may move (i.e., float) throughout the first chamber  23 . Rupturing of the container  40  may occur in a variety of methods, including physical manipulation of the shell  21 , or contact with an edge  61  (not illustrated). Container  40  may be made from the same materials as previously described for the shell  21 . The container  40  may be constructed to be weaker than the shell  21  due to thinner or weaker walls. The weaker construction ensures that upon activation, the containers  40  can be ruptured without rupturing the shell  21 .  
         [0059]     The number of separate containers  40  within the shell  21  may vary.  FIG. 4  illustrates a single container  40  within the shell  21 .  FIG. 5  illustrates the shell  21  that forms a rod and includes first and second containers  40   a,    40   b.  The shell  21  forms a first chamber  23 , with the first container  40   a  forming a second chamber  24  and the second container  40   b  forming a third chamber  25 . Multiple containers  40  may be the same size or different sizes such as illustrated in  FIG. 5  with the second container  40   b  being larger than the first container  40   a.  In this embodiment, a rupture device  60  is attached to the shell  21  to rupture one or both of the containers  40   a,    40   b.    
         [0060]     Physical segregation may further include injecting one or more of the precursor materials into the shell.  FIG. 6  illustrates a shell  21  including a single chamber  23  that contains a first precursor material. Shell  21  includes an inlet  26  for introducing additional materials and prevents the escape of material that is within the chamber  23 . A second precursor material is introduced into the chamber  23  through a syringe  109 . The syringe  109  includes a barrel  110  sized to contain a predetermined amount of the second precursor material. A plunger  111  fits within the barrel  110  and forces the second material through a port  112 . In use, the second material is placed within the barrel  110  either through introduction via the port  112  or through a proximal end of the barrel  110 . The port  112  is inserted through the inlet  26  and into the chamber  23 . The plunger  155  is depressed in a distal direction to force the second material from the barrel  110  and through the port  112  into the chamber  23 . Markings on the barrel  110  may indicate the amount of second material that is expelled through the port  112 . The introduction of the second material  24  begins the activation, which may further include additional physical manipulation of the shell  21  for full mixing.  
         [0061]     The syringe  109  may further include two or more separate barrels  110 .  FIG. 7  illustrates a syringe  109  with first and second barrels  110   a,    110   b  that are physically separated and each sized to contain one of the first and second materials. A plunger  111   a,    111   b  positioned within each barrel  110   a,    110   b  forces the materials  23 ,  24  into a mixer  113  where the materials are mixed together. A port  112  is positioned on the distal end of the mixer  113  for insertion into the inlet  26 . In one embodiment, the chamber  23  is initially empty with the body  21  assuming a predefined shape which in this instance is an interspinous spacer. In some embodiments, multiple inlets  26  are positioned within the body  21  for introducing the materials.  
         [0062]     Various notification methods may be used to indicate to the physician that activation has occurred. In one embodiment, the implant  20  becomes less malleable as the material or materials begin to cure and harden. The physician is able to tactilely feel this change and confirm activation. In one embodiment, the shell  21  is constructed of a translucent or transparent material. The precursor material or materials may change color upon activation. In one example, activation by an energy or electrical source causes the material or materials to change color. This change can be visually noticed by the physician. In one embodiment that includes mixing of two or more precursor materials, the materials may each have a separate color and mixing can be visually identified. In one embodiment, the mixed materials may change color. By way of example, a first precursor material may be blue and a second precursor material may be yellow. These two materials can be distinguished while physically separated. Upon mixing and activation, the mixed materials change to a green color. Visual and tactile indication may also be used to ensure that the precursor materials are fully mixed.  
         [0063]     The transformable implant  20  may be used in a variety of different medical contexts.  FIGS. 1A-1E  illustrates one embodiment for nucleus replacement of an intervertebral disc. In one embodiment, the implant  20  includes an annular shell  21  with a central opening  27 . The implant  20  is malleable prior to and during an initial period of activation to be deformed and fit within an opening in the annulus fibrosis  100 .  
         [0064]      FIG. 8  illustrates another embodiment of a nucleus replacement implant  20 . The implant  20  includes an annular shell  21  with an opening  27 . A conduit  28  extends through the shell  21  and into the opening  27  for introduction of filler material. Any suitable osteogenic material or composition is contemplated for the filler material, including autograft, allograft, xenograft, demineralized bone, and synthetic and natural bone graft substitutes, such as bioceramics and polymers, and osteoinductive factors. The terms osteogenic material or osteogenic composition used herein broadly include any material that promotes bone growth or healing including autograft, allograft, xenograft, bone graft substitutes and natural, synthetic and recombinant proteins, hormones and the like. Filler material is further disclosed in U.S. Patent Application Publication No. 2004/0102774 herein incorporated by reference in its entirety.  
         [0065]     The transformable implant  20  may also be used for full disc replacement following a discetomy or replacement of vertebral member and disc following a corpectomy. The implants  20  may include a variety of shapes and sizes depending upon the specific context of use.  FIG. 9  illustrates a spherical shell  21  including a seal  22  that divides the interior into three chambers  23 ,  24 ,  25  to physically segregate materials.  FIG. 10  illustrates an oblong shell with a container  40  for segregating the materials into the first and second chambers  23 ,  24 .  FIG. 11  illustrates an elongated shell  21  having a kidney shape that conforms to the shape of the adjacent vertebral members. This embodiment features first and second chambers  23 ,  24  formed by a seal  22  with an inlet  26  that leads into the second chamber  24 . In one embodiment, first and second materials are contained in the chambers  23 ,  24 , and a third material is introduced through the inlet  26 .  FIG. 12  includes a disc shape shell  21  with a semi-disc or half-disc shell  21  illustrated in  FIG. 13 . The embodiments of  FIGS. 12 and 13  include a single chamber  23  for containing a single precursor material. This material may be activated by non-mixing activation methods.  FIG. 14  illustrates an annular shell  21  having a substantially donut shape with a central opening  27  and seals  22  forming two separate chambers  23 ,  24 .  FIG. 15  includes a capsule-shaped shell  21  with a single seal  22  forming first and second chambers  23 ,  24 .  FIG. 16  includes a cylindrical shell  21  with three separate seals  22   a,    22   b,    22   c  forming four chambers  23 ,  24 ,  25 ,  26  and a container  40  positioned within chamber  26 .  FIG. 17  includes a tapered cylinder shell  21  with the height of a first sidewall  72  being greater than a second sidewall  73 . One or both of the superior and inferior surfaces  74 ,  75  are angled.  FIG. 18  illustrates an open-ring shell  21  with a gap  76  that leads into the opening  27 .  FIG. 19  includes a half-round shell  21  with an opening  27 .  FIG. 20  includes an I-shape with superior and inferior  74 ,  75  supported by an intermediate strut  77 . The embodiments of  FIGS. 17-20  include a single chamber  23  to hold a single precursor material. It is to be understood that the implant  20  may include various other shapes and sizes than those disclosed in these Figures. Additionally, the various embodiments may include various manners of containing the precursor material and materials.  
         [0066]     The implant  20  may also be used as a vertbroplasty device. A portion of the vertebral member may be hollowed or otherwise opened using a variety of methods including balloon expansion. The implant  20  may then be inserted into the hollowed section and hardened.  
         [0067]     In some embodiments, body  21  includes teeth  50  for preventing expulsion of the implant  20  after insertion. In one embodiment, teeth  50  are positioned about the entirety of the shell  21  as illustrated in  FIG. 19 . Teeth  50  may also be positioned on limited sections of the shell  21 , including the superior and inferior surfaces  74 ,  75  as illustrated in  FIG. 13 , and the superior surface  74  in the embodiment of  FIG. 12 . Teeth  50  may include a variety of shapes and sizes. Teeth  50  may each include the same shape and size, or may comprise a variety of shapes and sizes.  
         [0068]     Another intervertebral application includes the implant  20  acting as an intermediate support mechanism.  FIGS. 21A and 21B  illustrate an embodiment with first and second endplates  82 ,  83  positioned within the intervertebral space formed between adjacent vertebral members  300 . A distractor  200  may be positioned to establish a height of the intervertebral space. The first and second endplates  82 ,  83  may be positioned to contact the vertebral members  300 . The implant  20  is inserted while in a malleable state and deformed to fit between the endplates  82 ,  83 . The implant  20  cures to a hardened state to support the members  82 ,  83  at the desired spacing. The distractor  200  may remain in position to support the vertebral members  300  until the implant  20  cures to a hardened state, or may be removed once the implant  20  is inserted and prior to being completely hardened.  
         [0069]     In one embodiment, the insertion of the intervertebral implant  20  into the intervertebral space may cause distraction of the vertebral members. In one embodiment, the material or materials expand during curing to the hardened state to cause distraction.  
         [0070]     Implant  20  may further include a vertebral plate as illustrated in  FIGS. 22 and 23 . The plates may include a variety of lengths, widths, and thicknesses depending upon the context of use. Openings  27  may further extend through the plates for receiving fasteners for attachment to the vertebral members. The malleable nature of the plates may facilitate insertion in a more minimally-invasive manner than with traditional rigid plates. Further, the malleable nature provides for conforming the plate to the contours of the vertebral members.  
         [0071]     The implant  20  may also be formed as a vertebral rod. The rod may include a variety of lengths and diameters depending upon the use.  FIG. 5  illustrates one embodiment of a rod.  FIGS. 24A and 24B  illustrate one embodiment of inserting and attaching the rod implant  20  to the vertebral members  300 . An anchor  410  is mounted to each of the vertebral members  300 . Each anchor  410  includes a shaft  412  that extends into the vertebral members  300 , and an outwardly-extending head  413 . Head  413  may include a saddle with opposing arms forming a channel therebetween that is sized to contain the implant  20 . A fastener (not illustrated) may connect within the saddle to maintain the implant  20  within the channel.  
         [0072]      FIG. 24A  illustrates the implant rod  20  in a malleable state that is bent during insertion through an incision  310 . In this embodiment, a guide wire  411  guides the movement of the implant rod  20  during insertion into the patient and into each of the anchors  410 . The nature of the material provides for threading the implant rod  20  through each anchor head  413  as illustrated in  FIG. 24B . Once at this position, the material cures to a hardened state thus forming a load-bearing support for the vertebral members  300 .  
         [0073]     The implant  20  may also be used in an interspinous context.  FIGS. 2-4  illustrate embodiments of an interspinous implant  20  with opposing arms that form seats for positioning the spinous processes of the adjacent vertebral members  300 .  FIG. 25  illustrates another embodiment with less pronounced arms forming an indent to position the spinous processes.  FIG. 26  illustrates an embodiment with substantially planar inferior and superior surfaces that are spaced apart a distance to support the spinous processes.  
         [0074]     Various methods may be used during the insertion and positioning within the patient. One method includes the physician manually grasping the implant  20  and inserting it into the patient. The physician may also manipulate the implant  20  and position it within the patient.  
         [0075]      FIG. 27  illustrates a funneled cannula  210  that may be used during the process. The cannula  210  includes an enlarged proximal end  211  and a reduced distal end  212 . An opening  213  extends through the length and decreases from a first width w at the proximal end  211  to a second reduced width w′ at the distal end  212 . The implant  20  is inserted into the proximal end  211  and moved through the cannula  210  thereby deforming it and reducing a cross-sectional size. The implant  20  is reduced in cross-sectional size upon exiting through the distal end  212 . The cannula  210  may include a length to position the distal end  212  at the insert location within the patient with the proximal end  211  remaining on the exterior of the patient. The cannula  210  may be constructed of a rigid material, or may be flexible to facilitate insertion and positioning of the distal end  212  within the patient.  
         [0076]     In one embodiment, the implant  20  is moved through the cannula  210  by the fingers and hands of the physician. Another method may use a plunger  220  as illustrated in  FIG. 28 . Plunger  220  includes a shaft  223  that separates a head  221  and a handle  222 . The head  221  is sized to fit within the opening  213  and through the distal end  212 . The head  221  contacts the implant  20  and forces it through the length of the cannula  210  and into the patient. In one embodiment, head  221  is shaped to also position and mold the implant  20  when it is in the patient. In one embodiment, the head  221  is removable such that a first head moves the implant  20  through the cannula  221  and a second head is sized to mold and position the implant  20  once it has been delivered inside the patient. In another embodiment, a flexible member is tied to the implant  20 . The flexible member extends through a section of the patient and exits from a second incision. The flexible wire may then be used to pull the implant  20  through the cannula  210  and into position within the patient.  
         [0077]     Another method may include a hinged cannula  230  as illustrated in  FIGS. 29A and 29B . The cannula  230  includes a first section  231  and a second section  232  pivotally connected at one or more hinges  233 . In the open orientation as illustrated in  FIG. 29A , the interior of the cannula is exposed. In use, the implant  20  may be placed within the interior of the first or section sections  231 ,  232 . This may require that the implant  20  be deformed to fit within this space. The two sections  231 ,  232  are than brought together in a closed orientation as illustrated in  FIG. 29B . This movement may also deform the implant  20  and force it to fit within the interior space of the two sections  231 ,  232 . The deformed implant  20  has a reduced cross-sectional size and may inserted into the patient in a manner as described above.  
         [0078]      FIGS. 30A and 30B  illustrate another embodiment of a hinged cannula  230 . This embodiment includes one or more hinges  233  on the proximal end of the first and second sections  231 ,  232 . In the open position as illustrated in  FIG. 30A , the second section  232  lifts to expose the interior of the first section  231 . The implant  20  may be deformed during insertion into the first section  231 , and additional deformation may be occur when moving the second section  232  to the closed orientation. The implant  20  contained within the cannula  230  may be inserted into the patient as described above.  
         [0079]     The first and second sections  231 ,  232  or the various cannula embodiments may be substantially the same, or may be different.  FIGS. 29A and 29B  illustrate an embodiment with the sections  231 ,  232  being substantially the same.  FIGS. 30A and 30B  include the sections including a different shape and size. In one embodiment, the sections  231 ,  232  include an overall funnel shape with the distal end including a smaller size than the proximal end to facilitate insertion into the patient.  
         [0080]     In one embodiment, the material fills the shell  21  to an extent that the shell  21  inhibits the movement of the material. In one embodiment, shell  21  is non-compliant and the material completely fills the shell. This may reduce the overall malleability of the implant  20 , and may prevent deformation to an extent that the implant  20  can be inserted in a minimally-invasive manner. In one embodiment, a portion of the material is removed from the shell  21  prior to or during insertion. The removal allows for the implant  20  to be more malleable and be deformed for insertion in a minimally invasive manner. The amount of material that is removed from the shell  21  may affect the overall malleability with a larger removal providing for greater deformation. In one embodiment, at least a portion of the material remains within the shell  21  during insertion. After the implant  20  is within the body, the material may be reintroduced into the shell  21 . In one embodiment, a syringe  109  is inserted through an inlet  26  in the shell  21  to remove and reintroduce the material. The entire removed portion or a lesser amount may be replaced into the implant  20 . Additional components may also be added to the implant  20 .  
         [0081]     Syringes  109  may be used in some embodiments to introduce one or more precursor materials into the shell  21 . In other embodiments, a pump may be used to move the precursor material from a holding bin and into the shell  21 .  
         [0082]     The embodiments of the transformable implant  20  may be used for a variety of medical contexts. One context includes the spinal procedures including the cervical, thoracic, lumbar and/or sacral portions of the spine.  
         [0083]     The term “distal” is generally defined as in the direction of the patient, or away from a user of a device. Conversely, “proximal” generally means away from the patient, or toward the user. Spatially relative terms such as “under”, “below”, “lower”, “over”, “upper”, and the like, are used for ease of description to explain the positioning of one element relative to a second element. These terms are intended to encompass different orientations of the device in addition to different orientations than those depicted in the figures. Further, terms such as “first”, “second”, and the like, are also used to describe various elements, regions, sections, etc and are also not intended to be limiting. Like terms refer to like elements throughout the description.  
         [0084]     As used herein, the terms “having”, “containing”, “including”, “comprising” and the like are open ended terms that indicate the presence of stated elements or features, but do not preclude additional elements or features. The articles “a”, “an” and “the” are intended to include the plural as well as the singular, unless the context clearly indicates otherwise.  
         [0085]     The present invention may be carried out in other specific ways than those herein set forth without departing from the scope and essential characteristics of the invention. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive, and all changes coming within the meaning and equivalency range of the appended claims are intended to be embraced therein.