JP4917032B2 - Methods, materials, and devices for treating bone and other tissues - Google Patents

Description

RELATED APPLICATION This application claims priority from Israel application No. 166017 filed on Dec. 28, 2004. The present application is based on US Patent Law Section 119 (e), US Provisional Patent Application No. 60/59149 filed on July 30, 2004, and 60/647784 filed on January 31, 2005. And the benefits of 60/654495, filed February 22, 2005. This application claims priority from Israel Application No. 160987 filed on March 21, 2004, and based on Section 119 (e) of the United States Patent Act, No. 60 / 478,841 filed on Jan. 17, No. 60 / 529,612 filed Dec. 16, 2003, No. 60/534377, filed Jan. 6, 2004, and Mar. 18, 2004 It is also a partial continuation application of PCT application No. PCT / IL2004 / 000527 filed on June 17, 2004, claiming the benefits of the application No. 60/554558. This application is related to US patent application Ser. No. 09 / 890,172 filed Jul. 25, 2001, and US Patent Application No. 09 / 890,318, filed Jul. 25, 2001. The entire disclosure of these applications is incorporated herein by reference.

The present invention relates to the structural strengthening of the human body, for example by injection of materials that do not solidify into a hardened state.

BACKGROUND OF THE INVENTION A common symptom in the elderly is vertebral compression fractures that cause both pain and shortening of the height (or other distortions). One common treatment is vertebroplasty in which cement is injected into the fractured vertebra. This treatment repairs the fracture and reduces pain, but does not restore the vertebrae and the person to their original height. Another problem is that the injected cement may be injected out of the vertebra and migrate out through the vertebral crack. This can cause considerable physical harm.

  Another common treatment is spinal plasty, for example, where the balloon is first inflated inside the vertebra and then the fracture is reduced by injecting a fixation material and / or implant. Since lower pressures can be used to inject cement, the problem of cement transfer is mitigated but cannot be avoided.

  Some fixatives such as polymethyl methacrylate (PMMA) release heat and possibly toxic substances during solidification. These further weaken the bone and possibly lose the cement and / or break the bone.

  It has recently been suggested that some fixation materials that are harder than bone induce fractures in nearby bones.

  It is also known to use a bone-like repair material such as a bone powder slurry that does not induce such a fracture. However, such materials are difficult to inject due to their viscosity. There have also been attempts to reduce cement migration, for example, by injecting high viscosity cement during the doughing time and onset of polymerization. However, the proposed injection method requires higher pressure due to the high viscosity material. Also, certain viscous materials, such as curing PMMA, cure very quickly once a high viscosity is reached, so the time frame for workability at high viscosity is small. This has generally prevented the use of very high viscosity materials and the associated very high pressures. One possible reason is that as pressure increases, the physician may not be able to receive feedback regarding the body's resistance to cement injection. Thus, over-injection can easily occur.

  Another way to increase the viscosity for injection is to increase the monomer powder concentration ratio (MPR). However, it should be noted that an increase in cement MPR can lead to a significant decrease in some of the mechanical properties such as modulus, yield strength, and ultimate strength.

  U.S. Patents and Applications Nos. 4969888, 5108404, 6383188, 2003/0109883, 2002/0068974, 6348055, 6383190, 4494535, 4653489, and 4653487 are Various instruments and methods for treating bone are described, the disclosures of which are incorporated herein by reference.

SUMMARY OF THE INVENTION Aspects of some embodiments of the invention relate to both moving and supporting bone using the same material that is not encapsulated in a bag to prevent movement of the material. In an exemplary embodiment of the invention, a material that does not solidify into a hardened state is injected into the fractured bone and the fracture piece is moved under the pressure of the injected material. The injected material is maintained in the bone, for example supporting the bone and preventing bone retraction, either permanently or until the bone heals. Optionally, additional material or implants may be supplied to further support the bone, but the injected material is at least 20%, 30%, 40%, 50% of the force applied by the bone fragment , Or a lower, intermediate, or higher percentage. Optionally, the additional material is a cement that solidifies to a hardened state.

  In an exemplary embodiment of the invention, the material used is an artificial material. In an alternative embodiment of the invention, the material is a natural product.

In various embodiments of the present invention, the following types of materials are used.
(A) a relatively soft (compared to bone) solid material that can optionally be substantially plastically deformed without tearing and optionally does not contain crosslinks above Type I . In an exemplary embodiment of the invention, these materials are compressed radially and fed into the bone through a narrow hole. In an alternative exemplary embodiment of the invention, the material is provided in a compact state and is axially compressed for loading into the delivery system or simply propelled into the bone without initial compression.

In an exemplary embodiment of the invention, the soft material is a plastically deformable material. In examples of use within vertebrae, the deformation of at least 50%, 80%, 90%, 95%, or more is optionally a plastic deformation. Optionally, the material has an elastic deformation of 0.1% or less. In an exemplary embodiment of the invention, for a 1 mm thick material, the elastic springback is less than 0.1 mm, less than 0.05 mm, or less.
(B) High viscosity fluids such as bone slurry, semi-hardened cement, and putty-like materials. These materials are optionally flowed through the delivery system under high pressure. In some cases, the fluid solidifies into a cured state, for example, by a polymerization process or by contact with body fluids.

  Aspects of some embodiments of the invention relate to fracture reduction (eg, vertebral height restoration) using a soft material that is not constrained by an enclosure. In exemplary embodiments of the invention, the material is a soft material that is softer than 60, 70, 80, 90, or 100 Shore A. Optionally, the material is at least 10 Shore A or 20 Shore A, such as at least 20 Shore A or 30 Shore A.

  In alternative exemplary embodiments of the invention, the material is flowable with a viscosity of, for example, 100 Pascal seconds, 300 Pascal seconds, 500 Pascal seconds, 600 Pascal seconds, 800 Pascal seconds, 1000 Pascal seconds, or higher. Material. Optionally, the material is less than 4000 Pascal seconds, optionally less than 1800 Pascal seconds, optionally less than 1400 Pascal seconds, optionally less than 1100 Pascal seconds, or a smaller, intermediate or greater value. Having a viscosity of

  Aspects of some embodiments of the invention relate to the use of materials that do not solidify into a hardened state to support bone. In an exemplary embodiment of the invention, the material is injected into the bone.

  As used herein, the term “setting” refers to strength and / or due to chemical causes, for example, during and / or immediately after implantation, eg, polymerization after hours, days, or weeks. Or used to define materials with increased mechanical properties such as hardness. Note that the material that solidifies to an uncured state is a solidified material. Also, soft materials that have been solidified in advance generally do not solidify into a cured state.

  As used herein, the term “hardened condition” is used to describe a material that is 50% or more of the hardness of the cortical bone. In some cases, it is desirable to compare the strength and / or Young's modulus of the material with cortex and / or cancellous bone, in which case it is within 110% or 120% or 130% or an intermediate value of the bone value in question It is desirable that the value of

  In an exemplary embodiment of the invention, the material to be injected is selected to be of high viscosity, or a soft material that can be plastically deformed, for example by a material that does not tear during injection via a small diameter tube It is. Optionally, the material is mechanically sheared during injection.

  In an exemplary embodiment of the invention, the use of a non-hardening material, the time constraints typically involved in the use of a cement that solidifies to a hardened state such as PMMA, the time between mixing and solidification, particularly a given viscosity. Because the time in the range alleviates the time the doctor is restrained, it provides greater flexibility in the infusion method. Optionally, the non-curing material is easier to use because the user does not need to mix the material at the time of use. In an exemplary embodiment of the invention, the material is supplied to a preloaded magazine or delivery system.

  A potential characteristic of using high viscosity or soft solid materials is a low risk of leakage from the vertebrae. Optionally, various ingredients are added to the material, such as bone growth factors or radiopaque materials.

  A potential advantage of some pre-solidified or non-solidified materials is that an exothermic solidification reaction is avoided.

  In exemplary embodiments of the invention, the injected material contains no crosslinks or only type I crosslinks.

  Optionally, the injected material softens over time.

  In an exemplary embodiment of the invention, the material is prepared such that it cures in the presence of water or other common substances in the body, but does not solidify or cure outside the body. Thus, the materials can be pre-prepared and mixed and solidify after introduction into the body. Optionally, the material solidifies in 10-30 minutes or later.

  Aspects of some embodiments of the invention relate to the treatment of body tissue by injecting a non-solid or soft solid material harder than 10 Shore A. In an exemplary embodiment of the invention, the injected material flows into or is pushed into the body space and is thereby filled. In an exemplary embodiment of the invention, the injected material is sufficiently viscous or sufficiently solid so that it does not accidentally move out of the injected tissue, eg, out of the vertebra . This viscosity level used depends on the size and / or shape of the void leading out of the tissue to be treated. Optionally, the material solidifies into a cured state. Alternatively, the material does not solidify.

  In an exemplary embodiment of the invention, the material is provided under a pressure greater than 40 atmospheres.

  An aspect of some embodiments of the invention relates to a method of providing a flowable material or a soft solid material, optionally in a body in a predetermined amount of discrete units. In an exemplary embodiment of the invention, a delivery system with a first quantity of material is provided and the user can select this discrete quantity of the first quantity to be infused. This is in contrast to the continuous method in which material is injected until the user stops the injection or until all of the material is used. Optionally, the material to be injected is provided in a magazine from which one unit of material can be selected for injection. Optionally, the selection is made by separating the material from the magazine.

  In an exemplary embodiment of the invention, bone treatment is accomplished by injecting 2, 3, 4, or more discrete units of material.

  In some embodiments of the present invention, the potential advantage of working with discrete units that are significantly smaller than the total therapeutic amount is that the amount of material delivered per hour is reduced, thus reducing friction between the material and the delivery system. It is to be done.

  An aspect of some embodiments of the invention relates to the use of a sleeve to deliver a material or device implant having high friction to a delivery system to a site in the body. In an exemplary embodiment of the invention, the sleeve is designed to reduce friction between the material to be delivered and the delivery system. Optionally, the sleeve is provided inside the delivery tube. Optionally, force is applied directly to the sleeve to deliver the material or implant.

  An aspect of some embodiments of the invention relates to a system for delivering material into bone that is adapted to move over a guidewire. Optionally, the system moves over the guidewire when loaded. Alternatively or additionally, the system is loaded after being introduced into the body. In an exemplary embodiment of the invention, the system comprises a distal end adapted to penetrate a bone, such as a vertebra. In an exemplary embodiment of the invention, the system is adapted to deliver material into the vertebra to at least partially restore the height of the vertebra. In an exemplary embodiment of the invention, the material surrounds the guide wire.

  An aspect of some embodiments of the invention relates to a system for delivering material into bone under pressure, wherein the system is adapted to penetrate bone. In an exemplary embodiment of the invention, the system comprises a distal tip adapted to penetrate bone. Optionally, a hole is formed near the distal tip for delivering the material.

  An aspect of some embodiments of the present invention is a material for use in the body to support hard tissue that solidifies to a hardened state upon storage (eg, over an hour, or over a day or a week). Not related to materials. In an exemplary embodiment of the invention, the material comprises a polymer with no crosslinking or with type I crosslinking. Optionally, the composition of the material is a mixture of lauryl methacrylate (LMA) and methyl methacrylate (MMA), for example in a ratio between 90:10 and 10:90. Optionally, the material is not thermoset, but rather thermoplastic.

  In an exemplary embodiment of the invention, the material is a putty-like material. In one example, the material is composed of a mixture of hydroxyapatite and sufficient sodium alginate and will remain putty over time if the mixture is not in contact with water at least.

  In an exemplary embodiment of the invention, the material softens over time. Optionally, the material is composed of MMA and LMA with polyhema added and softens upon absorption of body fluids by the composition.

  Alternatively or additionally, water-soluble materials such as salts or materials that degrade in body fluids such as some sugars and plastics are added and when they degrade, the materials soften.

  In an exemplary embodiment of the invention, the material cures over time but does not cure completely. Optionally, the material includes a water soluble solvent such as NMP (N methyl pyrrolidone), and the material hardens somewhat as it dissipates.

  Optionally, the actual injected material includes one or more additive ingredients. Optionally, one or more of radiopaque labels, antibiotics, anti-inflammatory drugs, and / or bone growth factors are provided as additive components. Optionally, the additive component is added by an amount of less than 30% of the amount of material, and an amount of less than 50% in total of all additive components.

  Optionally, the additive material is chemically inert but can have structural effects, for example due to its bulk.

  Optionally, an inert material can be added, for example 5% of the cement that solidifies to a hardened state. Optionally, such inert materials are mixed in a coarse particle state.

  Aspects of some embodiments of the invention relate to the use of materials that solidify to a cured state and maintain high viscosity values during a significant time frame. In an exemplary embodiment of the invention, the viscosity is between 600 Pascal seconds and 1800 Pascal seconds for at least 5 minutes or at least 8 minutes. In an exemplary embodiment of the invention, the material is composed of a mixture of PMMA beads and / or styrene beads and MMA monomers, for example depending on the bead size of 10-200 microns and / or between the beads and the liquid MMA monomer. By changing the ratio, an increase in viscosity is achieved. Optionally, as solidification proceeds, the viscosity of the beads is replaced / increased by the polymerization process.

  An aspect of some embodiments of the invention relates to the treatment of compression fractures by heating the compressed vertebrae. Optionally, heating is achieved by a stand-alone instrument. Optionally, the heating is accomplished to replace the heating achieved separately by cement solidification. Optionally, a thermocouple or other temperature sensor is used to control the amount of heat provided.

  An aspect of some embodiments of the invention relates to a method of selecting the mechanical properties of an implant to match the mechanical properties of the cortex and / or cancellous bone to be treated. In an exemplary embodiment of the invention, hardness, strength, and / or Young's modulus are met.

  Accordingly, in an exemplary embodiment of the invention, (a) accessing the interior of the vertebra, and (b) providing a sufficient amount of an artificial biocompatible material that does not solidify during storage with the fracture portion of the bone. A method of treating vertebrae comprising introducing into the bone with a force sufficient to separate them.

  Optionally, the material does not solidify into a cured state after introduction into the body.

  In an exemplary embodiment of the invention, the material can be stored for more than one day.

  In an exemplary embodiment of the invention, the material softens after implantation.

  In an exemplary embodiment of the invention, the material is partially cured after implantation.

  In an exemplary embodiment of the invention, the material solidifies into a cured state after introduction into the body.

  In an exemplary embodiment of the invention, the material does not solidify into a cured state during storage.

  In an exemplary embodiment of the invention, the material is an artifact.

  In an exemplary embodiment of the invention, the material is a plastically deformable material. Optionally, the material has a hardness between 10 Shore A and 100 Shore A. Alternatively or additionally, the material has no higher cross-linking than Type I. Alternatively or additionally, the material is thermoplastic. Alternatively or additionally, the material comprises LMA (lauryl methacrylate) and MMA (methyl methacrylate).

  In an exemplary embodiment of the invention, the material is a viscous fluid. Optionally, the material has a viscosity between 600 Pascal seconds and 1800 Pascal seconds.

  In an exemplary embodiment of the invention, introducing comprises introducing at at least 40 atmospheres.

  In an exemplary embodiment of the invention, introducing comprises introducing at at least 100 atmospheres.

  In an exemplary embodiment of the invention, introducing comprises introducing through a delivery channel having a diameter of less than 6 mm and a length of at least 70 mm.

  In an exemplary embodiment of the invention, introducing includes introducing through an extrusion hole having a minimum diameter of less than 3 mm.

  In an exemplary embodiment of the invention, introducing includes introducing through an extrusion hole having a minimum diameter of less than 1.5 mm.

  In an exemplary embodiment of the invention, introducing includes introducing through multiple extrusion holes simultaneously.

  In an exemplary embodiment of the invention, the introduction includes changing the introduction direction during the introduction.

  In an exemplary embodiment of the invention, the introduction includes changing the introduction position during the introduction.

  In an exemplary embodiment of the invention, the material comprises at least one material adapted to function with capabilities other than structural support.

  In an exemplary embodiment of the invention, introducing includes advancing the material using a motor.

  In an exemplary embodiment of the invention, introducing includes advancing the material using a hydraulic source.

  In an exemplary embodiment of the invention, introducing includes introducing the material in discrete units. Optionally, at least some of the units have different mechanical properties.

  In an exemplary embodiment of the invention, introducing includes detaching the material from the delivery system.

  In an exemplary embodiment of the invention, introducing includes not twisting the material during the introducing.

  In an exemplary embodiment of the invention, the introduction includes shaping an extruded shape of the material using an exit hole.

  In an exemplary embodiment of the invention, access includes accessing with a guide wire and providing a delivery system over the guide wire.

  In an exemplary embodiment of the invention, access comprises accessing using the material delivery system.

  In an exemplary embodiment of the invention, introducing includes introducing without a separate void forming operation.

  In an exemplary embodiment of the invention, introducing includes introducing without a spatially constraining enclosure.

  In an exemplary embodiment of the invention, introducing includes introducing into a spatially constrained enclosure.

  In an exemplary embodiment of the invention, introducing also includes introducing a material that solidifies to a cured state of at least 10% by volume.

  In an exemplary embodiment of the invention, the method comprises selecting the material to have at least one hardness and Young's modulus properties lower than the vertebral trabecular bone one week after the implant. Including.

  In an exemplary embodiment of the invention, the introduced material acts to support at least 30% of the weight of the vertebra within one week from the implant.

In an exemplary embodiment of the invention, a surgical set comprising at least one instrument adapted to deliver material into a vertebra and at least 1 cc of an artificial biocompatible preparation material that does not solidify outside the body. Also provide. Optionally, the at least one instrument includes a pressure delivery mechanism capable of delivering the material at a pressure greater than 100 atmospheres. Alternatively or additionally, the set includes a disposable hydraulic actuator. Alternatively or additionally, the set includes a replaceable magazine for storing the material.

  In an exemplary embodiment of the invention, (a) accessing the interior of the bone; and (b) introducing a sufficient amount of biocompatible material into the bone without an enclosure between the material and the bone. A method of treating bone, wherein the introduction is performed with sufficient force to separate the fractured portion of the bone. Optionally, the method includes leaving the material in the bone to resist at least 30% of a normative force attempting to press the portions together.

  Optionally, the bone is a vertebra. Optionally, the material does not solidify into a cured state during storage. Alternatively or additionally, the material does not solidify into a cured state in the body.

  In an exemplary embodiment of the invention, (a) accessing the interior of the vertebra, and (b) a sufficient amount of spatially having a hardness of less than 100 Shore A with sufficient force to separate the fractured portion of the bone. A method of treating a vertebra including the step of introducing a biocompatible soft material into the vertebra that is not constrained to the vertebra.

  In an exemplary embodiment of the invention, at least one instrument adapted to deliver material into the vertebrae and a Young's modulus of less than 120% of healthy vertebral cancellous bone, prepared at least one day in advance A surgical set comprising at least 1 cc of biocompatible preparation material is also provided.

  In an exemplary embodiment of the invention, (a) accessing the interior of the bone; and (b) an unconstrained plastic deformation that is harder than 10 Shore A and softer than 100 Shore A into the bone via a delivery tube. A method of treating bone comprising introducing a possible solid material.

  In an exemplary embodiment of the invention, (a) a delivery tube having a lumen and a distal end adapted for insertion into the body, and (b) a payload comprising at least one of the material and implant within the lumen. And (c) a liner disposed between the tube and the payload; and (d) an advance mechanism adapted to move the liner and the payload to the far end, the liner comprising: There is also provided an apparatus for delivering a material or implant into bone that reduces friction of the payload against the delivery tube. Optionally, the device includes a splitter that divides the sleeve.

  In an exemplary embodiment of the invention, the mechanism pulls the sleeve.

  In an exemplary embodiment of the invention, the mechanism pushes the payload.

  In an exemplary embodiment of the invention, the sleeve is folded over the delivery tube.

  Exemplary embodiments of the present invention also provide a biocompatible material that does not solidify to a cured state, does not contain crosslinks greater than Type I, and is formed from MMA (methyl methacrylate). Optionally, the material is formed from a mixture of MMA and LMA (lauryl methacrylate).

  Exemplary embodiments of the present invention also provide a second medical application of PMMA to restore vertebral height when applied directly to the vertebra. Optionally, the PMMA is applied during solidification when the viscosity is greater than 400 Pascal seconds.

  It also provides a second medical use of a bone putty for treating vertebrae when applied into a vertebra through a tubular delivery system under pressure.

  In an exemplary embodiment of the present invention, a polymeric composition comprising (a) a first amount of beads having a set of sizes and (b) a second amount of monomer, wherein said amount of mixture results in There is also provided a polymerized composition, wherein said quantity is selected so as to obtain a solidified material having a workability time frame of at least 5 minutes with a viscosity between 500 and 2000 Pascal seconds.

  Exemplary embodiments of the present invention also provide a method of treating bone that includes providing a heat source in a vertebra in a controlled manner.

  In an exemplary embodiment of the invention, (a) a head adapted to penetrate bone, (b) a hole adapted to push material into bone near said head, and (c) said hole. There is also provided a composite device for accessing bone, comprising an elongate body having a lumen adapted to deliver material to the body and a source of material under pressure. Optionally, the instrument includes a guidewire lumen.

  In an exemplary embodiment of the invention, a drill tool including a lumen, a separable guidewire adapted to fit within the lumen, and a relative position of the drill tool and the guidewire are controlled. A composite instrument for accessing the bone is also provided with an adapted handle.

BRIEF DESCRIPTION OF THE DRAWINGS Non-limiting exemplary embodiments of the present invention are described in connection with the following description of embodiments with reference to the drawings. The same structure, element or part appearing in more than one figure is generally denoted by the same or similar numerals in all the figures.
FIG. 1A is a general flow diagram of a compression fracture treatment process according to an exemplary embodiment of the present invention.
FIG. 1B is a more detailed flow diagram of a compression fracture treatment process according to an exemplary embodiment of the present invention.
FIG. 2 illustrates a composite instrument for accessing vertebrae, according to an exemplary embodiment of the present invention.
3A-3F show the stages of an exemplary embodiment of the treatment method according to FIGS. 1A and 1B.
4A and 4B show a basic material delivery system according to an embodiment of the present invention.
5A and 5B show details of a material extruder tip according to an exemplary embodiment of the present invention.
FIG. 5C shows an elongated curved extrusion of the material according to an exemplary embodiment of the present invention.
6A-6C illustrate a narrow lumen of a delivery system according to an exemplary embodiment of the present invention.
FIG. 7A shows a hydraulic delivery system according to an exemplary embodiment of the present invention.
7B and 7C illustrate an alternative method of providing hydraulic power to the system of FIG. 7A, according to an illustrative embodiment of the invention.
7D and 7E illustrate an exemplary hydraulic system that includes a disposable unit, according to an exemplary embodiment of the present invention.
FIG. 8A shows a cassette-based delivery system according to an exemplary embodiment of the present invention.
FIG. 8B is a detailed diagram illustrating the delivery of unit elements according to an exemplary embodiment of the present invention.
9A and 9B show a material pusher with reduced material twisting, according to an exemplary embodiment of the present invention.
10A-10F show a sleeve-based material pusher according to an exemplary embodiment of the present invention.
11A and 11B show a squeeze-based delivery system according to an exemplary embodiment of the present invention.
12A and 12B illustrate a one-stage access and delivery system according to an exemplary embodiment of the present invention.
FIG. 12C illustrates a delivery system over a wire, according to an illustrative embodiment of the invention.
FIG. 13 is a graph illustrating the compressibility of a material according to an exemplary embodiment of the present invention.

Exemplary Process Overview FIG. 1A is a general flow diagram 100 of a process for treating a compression fracture, according to an exemplary embodiment of the present invention.

  At 102, the bone to be treated is identified. In the case of vertebrae, this typically includes X-rays or CT images to identify vertebrae or other bones that have been fractured, eg, by compression fracture. Although the following description focuses on vertebral compression fractures, some embodiments of the present invention are not limited to such cases.

  In an exemplary embodiment of the invention, access is minimally invasive, for example, only a single groove is formed in the body. Optionally, the procedure is performed by inserting a cannula having a diameter of, for example, 5 mm, 4 mm, or less into the body. In some cases, multiple openings into the body are formed. The procedure can also be performed using a surgical or keyhole design, but this may require a longer recovery time for the patient. Optionally, the cannula (and the corresponding length of the delivery tube described below) has a value of at least 50 mm, 70 mm, 100 mm, or more, or an intermediate value or less.

  At 104, the vertebrae are accessed.

  At 106, in some embodiments of the invention, a material having a high viscosity is injected into the vertebra.

  At 108, the material may optionally be restored in at least a portion of the height of the vertebrae, such as a percentage of 20%, 40%, 50%, or intermediate or higher of the precompressed height, and / or Provide quantity. A particular feature of some embodiments of the present invention is whether leakage from vertebrae is reduced compared to liquid PMMA cement because the provided material is of sufficient viscosity or is of sufficient solids. Or to be prevented. The pressure used to advance the material can be higher than is known in the art to match the increased viscosity.

  At 110, the procedure is complete and the tube is removed.

Exemplary Bone Access Set Before proceeding to procedure details, the instrument used will first be described. FIG. 2 shows a composite instrument 200 used to access bone, according to an exemplary embodiment of the present invention. In an exemplary embodiment of the invention, the access device used includes a set of component devices coupled to selectively operate as a single device or as separate devices. In an exemplary embodiment of the invention, the composite set / instrument serves as a one-stage access system that requires only one insertion of an object into the body. Optionally, as described below, the delivery system is also inserted simultaneously. Optionally, the cannula portion of the tool is omitted, for example as described in the embodiment of FIGS.

  In the exemplary embodiment of the invention, the components of instrument 200 are coaxially aligned components that fit within the lumen of the next part of each other.

  Optional cannula 202 includes a handle 204 and a body including a lumen.

  The optional drill tool 206 includes an elongate body and handle 208 adapted to drill a hole. Optionally, the handle 208 is selectively rotatably fixed to the handle 204 so that it can be operated with one hand and optionally with the snap lock 217. The body of tool 206 fits within the lumen of cannula 202. Optionally, the portion 210 of the tool 206 is labeled so as to be visible in the x-ray image, even in contrast to the cannula 202. Optionally, this can minimize the difference in diameter between cannula 202 and drill tool 206. In some cases, there is no such marker, the difference in diameter cannot be seen on the x-ray image and the two instruments cannot be distinguished.

  An optional guidewire 212 is provided within the lumen of the drill tool 206. Optionally, a knob or other control device 214 is provided to selectively advance and / or retract the guidewire 212 relative to the drill 216.

  Optionally, a depth indicator is provided on cannula 202.

  Exemplary uses of these instruments are described below, but FIGS. 3A-3F schematically illustrate progress as a vertebra 300 having a compression fracture 306 is treated, in parallel with the detailed flowchart 120 shown in FIG. 1B. Shown in

Bone penetration 122 (FIG. 1B) creates a passage to the bone through the skin layer 312 and intervening tissues such as muscle and fat. Optionally, the passage is formed by advancing the composite instrument / set 200 until the tip 218 of the guidewire 212 contacts the bone. In some embodiments, the tip 218 is designed to pierce soft tissue (eg, including a cutting edge). Alternatively or additionally, the tip 218 includes a puncture point adapted to form a puncture in soft tissue.

  This is shown in FIG. 3A. Vertebral cortical plates 302 and 304 and cancellous bone interior 308 are also shown.

  Because of the cross-sectional view, a single pedicle 310 is shown. Optionally, access to the vertebra is through the pedicle. Optionally, access is through both pedicles. Optionally, an extrapedic approach is used. Optionally, the access point or points are selected to help even lift the vertebra.

At bone penetration 124, the tip 218 penetrates the cortex of the bone to be treated (FIG. 3B). In the exemplary embodiment of the invention, the tip 218 is manipulated separately from the rest of the composite instrument 200. Optionally, tip 218 is advanced until it contacts the other side of the vertebra.

  In the exemplary embodiment of the invention, the tip 218 of the guidewire 212 is shaped to puncture the bone and advances through the vertebral cortex by rotation or vibration. Optionally, advance by tapping it or applying pressure to it.

  Optionally, focus on the relative position of the guidewire and cannula to help determine the internal extent of the vertebra.

  At 126, the guidewire is optionally retracted. Optionally, the guide wire is fixed to the drill tool 206 in the axial direction. Optionally, guidewire 212 and drill tool 206 are aligned such that tip 218 and drill tool tip 216 form a single drill tip.

  At 128, the drill tool 206 is advanced into the bone (FIG. 3C). Optionally, the tip 216 of the drill tool 206 is designed to pierce and / or advance, for example, by tapping or rotating and / or vibrating. Optionally, the drill tool is advanced beyond the vertebra. Optionally, this advancement is limited using a depth indicator in front of the guidewire. Optionally, the guidewire does not retract at 126. Instead, the drill tool 206 is advanced over the guidewire until it reaches the end of the guidewire.

  At 130, cannula 202 is optionally advanced through the drill to the bone. Optionally, the leading edge of the cannula is threaded or otherwise adapted to engage the bone in or near the hole formed by the drill tool. Optionally, a cannula is inserted into the bone.

  At 132, the guidewire and / or drill tool is optionally removed (FIG. 3D).

  In some embodiments, the cannula does not advance all the way into the bone. In another embodiment, the cannula can be advanced into the bone, eg, to prevent treatment and contact between cortical bone and / or weak and / or fractured bone. Optionally, the cannula is advanced over the pedicle and into the vertebral interior 308.

  Optionally, a reamer (not shown) is inserted into the cannula and used to remove tissue from the interior 308.

With infusion material 134, a material delivery system 314 is provided in cannula 202 (shown in FIG. 3E). Optionally, the delivery system delivers the material to its side (described below).

  At 136, the system 134 is activated and material 316 is injected into the interior 308. FIG. 3E shows that the vertebral height can be partially or fully restored when sufficient material is injected. The injected material partially or completely compresses the interior 308.

At feedback 138, feedback is optionally provided to the operator to determine if the infusion is complete. Optionally, feedback is provided by fluorescence imaging of the site. However, other imaging methods can be used.

  Optionally, non-imaging feedback, eg, pressure in the vertebrae, is provided using a pressure sensor (not shown) or using an indicator (visual or audible) of the amount of material injected.

  Optionally, the feedback determines if the procedure is proceeding as desired, for example, a desired amount of height recovery (if any), confirms that there are no material leaks, symmetry or asymmetry and Used to determine the presence or absence of new bone fractures.

Repeating and / or changing Optionally, the material is provided in a magazine having a fixed amount (described below). If the magazine is used up and additional material is needed, refilling can be achieved (140), for example by replacing the magazine with a new one.

  Optionally, the delivery characteristics of the material, such as delivery pressure, delivery rate, delivery amount when delivery is performed in discrete units, viscosity, composition and / or type of delivered material, preheating or precooling of the material, One or more of the delivery position within the vertebra, the spatial pattern and / or the direction of delivery within the vertebra are altered.

  Optionally, the material delivery direction is changed (142), eg, to help maintain lifting symmetry, or so that the point of material injection is away from the fracture site or toward a blank space. Optionally, the direction of delivery is changed by rotating delivery system 314. Alternatively or additionally, the injection is continued through a new access hole in the vertebra. Optionally, the cannula moves axially.

  Optionally, different materials are used to complete the procedure. The inlet holes are sealed and / or the uncured material is cured (144) using, for example, a cement that solidifies to a cured state (eg, PMMA).

At completion of treatment 146, the instrument is removed. FIG. 3F shows the vertebra 300 after the procedure is complete. Optionally, the entrance incision is sealed, for example using tissue glue or suture.

Exemplary Basic Delivery System FIGS. 4A and 4B illustrate a basic delivery system according to an exemplary embodiment of the present invention.

  FIG. 4A is a cross-sectional view of a delivery system 400 that generally consists of a delivery tube 402 having one or more extrusion holes 404. Optionally, the distal end of tube 402 is sealed. Alternatively, it can be at least partially open so that forward injection of material is achieved. Note that when the end is sealed, the force acting to retract the delivery system from the vertebra is reduced. The material inside the tube 402 is advanced by the thread pusher 406.

  In the illustrated design, the tube 402 is attached to the barrel 408 by a permanent or provisional attachment method. A thread (not shown) that matches the thread of the pusher 406 can be provided inside the barrel 408. Alternatively (not shown), the inner diameter of barrel 408 is larger than that of tube 402. Optionally, barrel 408 and / or tube 402 serve as a reservoir of material.

  A body 410 that acts as a nut and includes an internal thread engages the pusher 406. In an exemplary embodiment of the invention, when the handle 412 of the pusher 402 is rotated (while being held on the body / nut 410), the pusher 406 is advanced and material is injected into the body through the hole 404. Optionally, the barrel 408 is detachable from the body 410 to replace the barrel 408 with a barrel filled with material, for example when one barrel is empty. The coupling can be, for example, a threaded connection, or a quick connection, such as a rotating snap fit. Optionally, tube 402 is removable from barrel 408 using, for example, the same type of connection.

  In an exemplary embodiment of the invention, when the distal tip of pusher 406 passes through hole 404 (in embodiments where the pusher is very long), the passage separates the material from the material that exits the hole before the pusher and Release the material from the delivery system.

  FIG. 4B shows an alternative embodiment of a delivery system 420 in which a different design of the hole 424 is used. In this embodiment, the delivery tube 422 serves as a barrel and material reservoir and is optionally removable from the threaded nut body 430. Optionally, tube 422 is long enough to contain a sufficient amount of material to infuse, eg, 8-10 cc. Optionally, the body 430 includes a pistol or other grip (not shown) and can be threaded to engage the pusher 426 as described above.

  In an exemplary embodiment of the invention, the delivery system is formed from a metal, such as stainless steel. Alternatively or additionally, at least some of the components are formed from a polymeric material such as PEEK, PTFE, nylon, and / or polypropylene. Optionally, the one or more components are formed from, for example, a metal coated with Teflon to reduce friction.

  In an exemplary embodiment of the invention, the pusher thread is made from Nitronic 60 (Aramco) or Gall-Tough (Carpenter) stainless steel.

  In an exemplary embodiment of the invention, a ball screw is used instead of a standard thread. Optionally, the use of a ball screw increases energy efficiency and facilitates manual system operation as shown in FIGS. 4A and 4B. Optionally, a gasket is provided to separate the ball from the material.

  In an exemplary embodiment of the invention, the delivery material is provided as an elongated sausage shape having a diameter similar to the delivery tube and / or hole. Optionally, a long delivery tube is provided. Alternatively, a plurality of such string / sausage types are embedded. Optionally, the material is provided with a diameter, for example 0.1 to 0.01 mm smaller than the delivery tube, so that friction is reduced.

Exemplary Extrudate Details Returning to FIG. 4A, it is noted that the proximal extrusion hole 404 is optionally smaller than the distal extrusion hole. Optionally, the relative size is selected such that the extrusion rate and / or force of the two holes are the same. Alternatively, the holes are designed to have different speeds and / or forces. With reference to FIG. 4B, three axially spaced holes are provided and the cross-sectional shape of the extrudate can be such that maximum extrusion and / or force is applied to the middle hole. .

  In an exemplary embodiment of the invention, the size of the hole is selected so that the total amount of material to be ejected is as desired, taking into account the possibility of sealing part of the hole due to pusher advancement. The

  In an exemplary embodiment of the invention, the holes are designed such that the extruded material is ejected perpendicular to the delivery system. Optionally, the delivery system is configured such that the jet is angled, for example, angled in the plane of the axis and / or angled in a plane perpendicular to the axis. Optionally, the angle is selected to offset forces that tend to push the delivery system out of the vertebra. Alternatively or additionally, the angle is selected to coincide with the desired lifting direction of the vertebra or to prevent direct lifting, for example by the ejected material. Optionally, the delivery system is inserted into the vertebra at the desired angle. Optionally, the angles of the different holes, eg, the holes on both sides of the delivery tube, are different, eg, a 180 degree angle between the holes on either side, or a more acute angle (towards the proximal side) or an oblique angle. Make it. In exemplary embodiments of the invention, the extrusion angle is 30 degrees, 45 degrees, 60 degrees, 80 degrees, or a smaller, intermediate, or larger angle with respect to the tube axis. Optionally, the material is extruded with a bending radius of 1 mm, 2 mm, 3 mm, 4 mm, 5 mm, 10 mm, or an intermediate, smaller or larger radius.

  The radial arrangement of the extrusion holes can be of various designs. In one example, three, four, or more rows of holes are provided in the axial direction to ensure even filling of the space 308, for example. Each row can have, for example, one, two, three, or more holes. In another example, the holes are provided only on both sides so that, for example, the user can choose whether or not to push toward the cortical plates 302 and / or 304.

  Rather than a row, a staggered arrangement can be used. One possible advantage of the staggered arrangement is that the delivery tube becomes too fragile with the aligned holes.

  FIG. 5A shows a design of a delivery tip 500 using a circular hole 502 in a staggered row design. FIG. 5B shows a design of a delivery tip 510 with rectangular holes 512 arranged in a non-staggered manner.

  As shown, the shape of the holes can vary, for example circular, elliptical, square, symmetrical or asymmetrical in the axial direction, parallel or non-parallel to the tube axis, and / or elongated. Optionally, the hole edges can be jagged. Optionally, the hole shape is selected for one or more of the following reasons: extrudate shape, prevention of hole damage, and / or prevention of delivery tip damage. Optionally, the holes have a mouth (optionally pointed inward) that helps shape the extrudate. For example, the mouth can have a width between 0.1 and 1 mm, for example 0.3 mm or 0.5 mm.

  In an exemplary embodiment of the invention, the delivery tube is rigid. Optionally, the delivery tube is flexible or can be mechanically shaped (eg, using a vise) prior to insertion. In an exemplary embodiment of the invention, the cannula is flexible and a delivery tube with a curved tip can be inserted.

  In an exemplary embodiment of the invention, the type of delivery tip used is selected by the user. Optionally, the delivery tip is interchangeable and is attached, for example, by screwing into the delivery system.

  Optionally, an overtube or ring is optionally provided on a portion of the delivery system to selectively shield one or more holes.

  Briefly referring to FIG. 7A, a delivery tip 702 is shown that is provided with a guiding ramp 706 to guide the ejected material out of the hole 704. Optionally, the use of such ramps can reduce flow turbulence / material distortion and / or help reduce friction and / or improve control over the shape of the extrudate. Note also that the extrusion of the material occurs only on one side of the delivery system. This makes it possible to better control the force vector inside the vertebra caused by the extrudate. In an exemplary embodiment of the invention, the angle defined by the guiding ramp (90 degrees and in the plane of the tube axis) helps determine the extrusion direction.

  Also shown in FIG. 7A is a non-twisted pusher 708, which can alleviate other problems such as turbulence, friction, and / or voids in extruding material.

  FIG. 5C shows a delivery tip 520 in which material 526 is extruded into a curved extruded shape 522 by a pusher 528. In the exemplary embodiment of the invention, the curvature is controlled by controlling the relative friction of the proximal side 532 and the distal side 530 of the hole 524. Alternatively or additionally, the degree of curvature depends on the size of the hole and the shape of the ramp. Optionally, the material can be plastically deformed by extrusion and maintain a shape imparted to prevent contact with the deformed surface (eg, a bone plate).

  Alternatively or additionally, the extrudate 522 can be curved or bent due to the axial movement or rotational movement of the tip 520. Optionally, rotation is used to fill the space 308 more evenly.

  In an exemplary embodiment of the invention, the delivery tube moves and / or rotates during delivery. Optionally, the gear mechanism couples pusher movement with tube rotation and / or axial movement. Optionally, manual movement is achieved by the operator. Optionally, a vibrator is coupled to the delivery system.

  One consideration shown above is that the amount of material in barrel 408 may not be sufficient to complete the procedure. An aligned design is shown in FIG. 6A where the diameter of the inner lumen 602 of the barrel 408 is the same as the diameter of the lumen 604 of the delivery tube 402. Longer delivery tubes / barrels may be required to reduce the number of barrel changes.

  FIG. 6B shows an alternative design where the barrel 408 'has a lumen 606 with a larger inner diameter and thus a larger storage capacity. Optionally, this large diameter provides an additional hydraulic amplification factor as the diameter changes. Optionally, sudden changes in diameter can cause turbulence, resistance, and / or void formation. Depending on the material, it may be necessary to compress the material as the diameter changes. Optionally, as shown, the diameter is progressively changed, with intermediate ramp 608 having an inner diameter that varies between the diameters of lumens 606 and 604. Optionally, the pusher has a diameter that matches the lumen 606 and does not fit within the lumen 604. Optionally, an extension that fits within lumen 604 is provided on the pusher.

  Referring to FIG. 6C, a gradually changing lumen 610 is provided in the barrel 408 ''. Optionally, the distal end of the pusher is formed from a flexible material that can follow the change in diameter. Optionally, the flexible material is harder than the injected material. Alternatively or additionally, the distal end of the pusher is shaped to match the shape of the lumen 610.

  In an exemplary embodiment of the invention, the lumen of the barrel is larger than the diameter of the pusher, at least at the proximal portion of the barrel. After the pusher has advanced a quantity of material into the bone, the pusher is retracted and the material remaining in the barrel is reconfigured so that it is advanced by the next advancement of the pusher. Optionally, reconfiguration is performed by advancing a second plunger having a diameter similar to that of the barrel. Optionally, the plunger is coaxial with the pusher.

  The delivery tube can have various cross-sectional shapes, such as circular, rectangular, arcuate, and / or square. Optionally, the cross section matches the shape of the extrusion hole. Optionally, the inside of the hole is sharply shaped to cut as the extruded material advances, instead of or in addition to plastically deforming or shearing it.

Exemplary Viscosity / Plasticity and Pressure In an exemplary embodiment of the invention, the provided material has a viscosity greater than 600 Pascal seconds. Optionally, the material is delivered into the body using a pressure of at least 40 atmospheres or more, such as 100 or 200 atmospheres or more. If the material is plastic, it can have a hardness of between 10 Shore A and 100 Shore A, for example.

  In an exemplary embodiment of the invention, the pressure requirement is relaxed if a void is formed at the beginning of the procedure, for example by bone access or by rotation of the delivery system.

  In exemplary embodiments of the invention, the outer diameter of the delivery system is, for example, 2 mm, 3 mm, 4 mm, 5 mm, or a medium, smaller or larger diameter. Optionally, the wall thickness of the delivery system is 0.2 or 0.3 mm. Optionally, the wall thickness increases towards the distal tip.

  The pressure used for delivery is the friction between the material and the delivery system, the length of the material being pushed, the pressure applied to the material, the pressure that the material wants to apply to the vertebra, the way the extrudate applies pressure to the vertebra It should be noted that this depends on one or more of the viscosity of the material, and / or other sources of resistance to material movement.

  Low pressure can be used if, for example, the vertebrae may be damaged or if there is a possibility of material leakage.

  The volume injected can be as high as 2-4 cc, 8-12 cc or more for typical vertebrae, for example. Other amounts may be appropriate, for example depending on the volume of the space 308 and the desired cure of the injection.

  In an exemplary embodiment of the invention, the rate of infusion is 0.25 cc / sec. Higher or lower speeds can also be used, for example, between 25 cc / sec and 0.1 cc / sec or less, and between 25 cc / sec and 1 cc / sec or more. Optionally, the speed is controlled using electronic or mechanical circuitry. Optionally, the speed is determined by the operator in response to bone deformation as a function of the pressure expected or imaged as a function of pressure. Optionally, the speed varies over the length of the treatment. For example, the first is high and the last is low. Optionally, the rate of injection is controlled (or automatically) by the operator in response to a feedback mechanism such as fluoroscopy.

Hydraulic Material Supply System FIG. 7A shows a hydraulically powered delivery system 700. The delivery tube 710 is filled with a material that is ejected into the body. Tube 710 is optionally removable via connection 712 with body 714. Optionally, the connection is made by screwing. Alternatively, a fast connection method such as snap connection is used.

  The body 714 converts the hydraulic pressure provided via the input port 716 into advancement of the pusher rod 708. Optionally, body 714 is integral with tube 710, which prevents tube 710 from being replaced when the material to be ejected is exhausted.

  In an exemplary embodiment of the invention, the incoming hydraulic (or barometric) fluid pushes piston 718, which advances pusher 708 directly. Optionally, the hydraulic advantage is achieved by the ratio of piston and pusher. Optionally, a spring 720 is provided to retract pusher 708 when fluid pressure is released.

  Optionally, one or more spacers 722 are provided around pusher 708 to prevent buckling. Optionally, a spacer is provided on the spring 720. Optionally, spacers are provided at several axial positions. Instead of spacers, fins may extend from the pusher 708 to the body 714.

  Optionally, during use, the pressure drops when the material is used up. Pusher 708 is retracted and delivery tube 710 is replaced. Optionally, a barrel filled with injectable material is provided that is separate from the tube 710 so that the tip 702 does not need to be removed from the body.

  Figures 7B and 7C illustrate two alternative ways of providing hydraulic power. In FIG. 7B, a foot pedal pump 740 is used and the user places his foot on the pedal 744 and compresses the plate 742. Various foot pumps are known in the art. Optionally, pressure is relieved after prolonged compression. Optionally, the hydraulic subsystem is a sealed system (eg, containing fluid) provided for ready use by the user and / or merchant. An exemplary length of the flexible tube is between 0.2 and 3 meters, for example between 1 and 2 meters. However, longer lengths can be used.

  FIG. 7B also shows a variation of the body 714, designated 714 '. Instead of a single spring 720, two springs 720 'are shown with a spacer between the springs. Optionally, the use of multiple springs helps maintain the spacer near the middle (or other relative length unit) of the pusher at risk of buckling.

  FIG. 7C shows an alternative embodiment in which a hand pump 760, which can be any type known in the art, for example, a mechanism 762 consisting of a piston 764 and a cylinder 766, is used. Optionally, pumping is performed by rotating piston 764 relative to cylinder 766, and these components include matching threads. Alternatively, linear motion is used. Optionally, a hydraulic gain is achieved between the pump and the delivery mechanism, for example a gain of 1: 3, 1: 5, 1:10, or a smaller, intermediate or larger gain.

  In an exemplary embodiment of the invention, the hydraulic system is provided as a disposable unit with a non-disposable (or disposable) foot pump.

  FIG. 7D shows a disposable mixing and storage chamber 770 and FIG. 7E shows a reusable pump 750 with a disposable hydraulic capsule 754.

  Referring to FIG. 7D, the same capsule 770 is optionally used both for mixing materials and for storage / delivery. Optionally, the material is a solidifying cement such as PMMA. In the hydraulic delivery stream embodiment, the flexible tube 772 is optionally permanently connected to the pump (FIG. 7E). As fluid is provided through tube 772, piston 774 moves within cylinder volume 776 and pushes material (eg, into the delivery system). In the figure, the capsule is shown with a mixer 778 mounted thereon. Optionally, material is provided in volume 776 using a removable funnel (not shown), then the funnel is removed and a mixer 778 is inserted instead. In the exemplary mixer shown, the cap 782 covers the cylinder 776. When mixing is complete, the cap can be replaced with a fitting adapted to couple to the delivery tube.

  In use, the handle 780 is rotated to rotate the shaft 786 having a rotor 788 defined as a helix in the shaft, for example. An optional stator 789 is provided. An optional vent 784 can be connected to a vacuum source to draw out toxic and / or odorous gases generated by the solidification of the material. Optionally, the viscosity of the material is estimated by the difficulty of rotating the handle. Optionally, the handle includes a clutch (not shown) that skips when the desired viscosity is reached. Optionally, the clutch can be set. Optionally, a viscometer is used or the viscosity is estimated based on temperature, blending, and mixing time.

  Cap 782 optionally includes a squeegee or other type of wiper to drop material from mixer 778 when removed from capsule 770.

  Referring to FIG. 7E, the tube 772 is connected to a capsule 754 that includes a piston 798 and a volume 797 pre-filled with fluid. In an exemplary embodiment of the invention, a frame 756 is provided in the upper body attached to the pump 750 to selectively receive the capsule 754.

  The pump 750 is, for example, a hydraulic pump mechanism 752 that extends a push rod 795 that moves the piston 798 forward.

  In the illustrated embodiment, a foot pedal 758 attached to the shaft 791 pushes the piston 755 into the cylinder 792. One-way valve 794 causes fluid in cylinder 792 to flow into volume 749 where the fluid pushes piston 757. When the pedal 758 is released, a spring (not shown) pulls it back to the up position, causing hydraulic fluid to flow from the storage chamber 759 (eg, surrounding the pump) through the one-way valve 793 and into the cylinder 792.

  A pressure relief valve 751 is optionally provided to prevent over pressurization of the cylinder 749. In an exemplary embodiment of the invention, spring 796 is provided to push piston 757 and pusher 795 back when pressure is released. Optionally, the pressure is relieved using a manually operated bypass valve 753. Once pusher rod 795 is retracted, capsule 740 is optionally removed.

Unit Material Delivery System FIG. 8A shows that material is provided as discrete units, each of which is a relatively small amount, eg, 1/2, 1/4, 1/7, 10/0 or less of the amount needed for treatment. A delivery system 800 is shown. One potential advantage of working with a unit is that the operator is well aware of the effects of his / her measures since each measure can only inject one unit. Another potential advantage of working with the unit is that it can provide units with different material properties during the procedure. Another potential advantage is that the small unit typically exhibits less friction against the delivery system.

  System 800 includes a delivery tube 802 having one or more extrusion holes 804 at its tip. The barrel 808 provided with the tube 802 also includes an optional magazine 820 described below. An optional nut threaded body 818 is optionally attached to the barrel 808. Pusher 810 resides within delivery tube 802 and / or barrel 808.

  In the exemplary embodiment of the invention, handle 812 includes a battery-powered mechanism for advancing pusher 810. Alternatively, a hydraulic system as described above may be used. Optionally, one or more switches or multiple switches, such as an on / off switch 816 and a direction switch 814 are provided. Optionally, when pusher 810 completes its forward movement, it automatically retracts. Optionally, only a single switch is required that triggers one unit of extrusion when activated. In the exemplary embodiment of the invention, handle 812 is rotationally secured to body 818 using, for example, one or more guide pins.

  In the exemplary embodiment of the invention, handle 812 includes a motor and a battery that rotate pusher 810. Alternative mechanisms are described below.

  Referring to magazine 820, in an exemplary embodiment of the invention, the magazine includes discrete units 822 of material (one unit 824 is shown in tube 802). Optionally, a spring 826 is used to push the unit in the direction of tube 802. Optionally, the magazine is filled with a continuous amount of material and the unit is defined by a cutting action caused by a pusher 810 that pushes a unit of material away from the magazine.

  In an exemplary embodiment of the invention, the magazine is pre-created by a manufacturer who fills the magazine with non-solidified material, for example.

  In an exemplary embodiment of the invention, the magazine is loaded with a series of units with different characteristics, eg, depending on the expected progress of the procedure. For example, provide a soft material first and then a harder material, or vice versa. Alternatively, a rotating magazine is used, and the user can select which of several compartments are next loaded into the barrel 808. This allows for fine tuning of the injected material. In an exemplary embodiment of the invention, the operator can remove the magazine 820 at any time and replace it with a different magazine. Optionally, this is done while pusher 810 is in front so that there is no risk of backflow from the body.

  Optionally, the one or more units comprise or are an implant device (rather than an amorphous and / or homogeneous mass), for example an expandable implant or an implant that does not change geometry . Optionally, the one or more units comprise a cross-linking material.

  In an exemplary embodiment of the invention, the delivery system used includes two or more delivery tubes (optionally the coupling shape has a circular or 8-shaped cross section). Optionally, each tube has a separate pusher mechanism and / or a separate source of material (eg, a magazine). Optionally, two tubes are used simultaneously. Optionally, an operator can selectively use one tube. Optionally, the material provided in each tube is a component that chemically reacts with each other. Optionally, electronic control is provided to control the relative feed rates of the two tubes. Optionally, this allows control of the final material proportion. Optionally, the use of two or more tubes allows for the formation of a layer structure within the body. Optionally, one of the tubes delivers solidified material and the other tube delivers non-solidified material. In an alternative embodiment, each tube is used to provide a different component of the two component material. Optionally, the two tubes meet at their distal ends to ensure mixing of the components.

  In an exemplary embodiment of the invention, the material delivered is Orthovita Inc., a composite of Bis-GMA, Bis-EMA, and TEGDMA. CORTOSS manufactured by (USA).

  In an exemplary embodiment of the invention, the partial unit behavior is achieved by a motor on the handle 812 that stops after each “unit” advance, instead of a unit provided by a magazine or by a cutting mechanism. Optionally, when using a hydraulic mechanism, a mechanical stop for the mechanism is provided. Optionally, instead of stopping, a sound is generated when the unit is injected or based on different logic, for example, when 50% or another percentage of the planned amount of material is provided . Optionally, a CPU is provided to analyze the image provided by the imaging system and generate a signal when sufficient and / or nearly sufficient and / or overloaded material is provided. Other circuit mechanisms can also be used.

  Optionally, a circuit mechanism is provided for controlling the rate and / or pressure of the material supply. Optionally, the circuitry stops when a sudden change in resistance is perceived.

  In an exemplary embodiment of the invention, the delivery system includes preheating or precooling of the injected material and / or tube 802. In an exemplary embodiment of the invention, a Peltier cooler and / or resistance heater is provided in barrel 808. Other cooling or heating methods can be used, such as those based on chemical reactions or phase change materials.

  In an exemplary embodiment of the invention, the magazine is a long coiled magazine. Alternatively or additionally, the deformable material is folded in the magazine. Optionally, the magazine is long. Optionally, separate loading and pushing mechanisms are provided. In an exemplary embodiment of the invention, the unit is inserted through a slot on the side of the barrel for loading. Due to the indentation, the unit moves forward through the slot under low pressure (or the slot is sealed) and only afterwards, for example, once the leading edge of the unit has reached the extrusion opening, it is notable to advance the unit. Pressure is required.

  FIG. 8B shows the realization of the unit delivery method without a cassette. The delivery tip 840 of the hole 842 is illustrated and a plurality of units 822 are illustrated therethrough. Optionally, an indication is provided to the user when the unit is ejected, for example based on the movement of the pusher used. Optionally, the system of FIG. 8A is used to pull the pusher back and load a series of units 822 into the barrel after each unit has advanced past the cassette.

Battery-Driven Pusher FIGS. 9A and 9B show a material pusher 900 with reduced material twisting, according to an illustrative embodiment of the invention.

  In the delivery system described above, the pusher 900 includes a delivery tube 902 having one or more holes 904 near its ends. Optionally, ensure centering (or other positioning) of the extruded material, for example, to prevent material from being provided too close to the distal end of the vertebra when the delivery system is pushed forward, for example In order to do so, an offset is provided between the hole and the distal end of the tube 902.

  A tube 902 is provided on the body 908 (eg, optionally replaceable). Pusher 910 is used to advance the material within tube 902.

  In an exemplary embodiment of the invention, during use, an operator presses switch 912 to select pusher 910 forward, backward, and no movement. It is transmitted to a power motor 916 from a battery 914 (or hydraulic or other source). The rotation of the motor causes the nut 922 to rotate relative to the pusher 910. Optionally, a series of gears is used, which may or may not provide mechanical advancement depending on the implementation. In the exemplary embodiment of the invention, motor 916 rotates gear 918, which rotates gear 920, which rotates nut 922 coaxial with them. Optionally, an anti-rotation element 924, such as a rectangular element 924, is attached to the pusher 910 to prevent its rotation.

  Optionally, one or more sensors are used to detect the extremes of the position of the pusher 910 as the pusher advances and retracts. In the example shown, macro switch 926 and macro switch 928 detect the end of movement of pusher 910 using, for example, a bump or conductive portion 930 (depending on the type of sensor used). Alternatively or additionally, for example, a position encoder is used by counting the rotation, or a separate encoder known in the encoder art.

  FIG. 9B shows the system 900 after extrusion has been performed, and the extrudate 932 is shown. Optionally, extrudate 932 is an extension of tube 902 before being cut by pusher 910. In the exemplary embodiment of the invention, rotation of tube 902 causes extrudate 932 to operate as a reamer. In an exemplary embodiment of the invention, the viscosity and shear strength of the material are selected to achieve the desired limits of the reaming capability, eg, to prevent bone damage.

  Optionally, one or more gears are provided to rotate and / or vibrate between delivery as the material is advanced. Optionally, periodic or gradually increasing axial movement is achieved by the motor means. Optionally, the distal tip of the delivery tube can be softened, for example by attaching a soft tip thereto, to reduce or prevent vertebral damage.

Sleeve Providing System FIGS. 10A and 10B illustrate a sleeve based delivery system 1000 according to an exemplary embodiment of the present invention. FIG. 10A is a schematic cutaway view of system 1000, with sleeve 1010 not shown. FIG. 10B shows the distal portion of the system 1000 including a sleeve 1010 attached to the system 1000.

  The embodiment of FIGS. 10A and 10B also shows a refill mechanism that includes a port through which the delivery tube can connect a refill system to refill the delivery tube with material to be injected into the body.

  Pusher 1004 pushes the material to be detected in delivery tube 1002. In the illustrated embodiment, material is injected through the tip 1008 of the delivery tube 1002. Sleeve 1010 is provided such that the sleeve is located between the material and delivery tube 1002. An optional tube cutter 1012, such as a knife, is shown to optionally split the tube after it has exited the body. A pulley system 1011 for collecting the separated tubes is also shown.

  In operation, an amount of material is either provided in the tube 1002 or injected into it, for example, via the port 1016 of the pusher 1004. The material in the tube 1002 is pushed in, for example, manually using a motor, or using other mechanisms described herein, such as by advancing the pusher 1004 by applying force to the knob 1018 attached to the pusher. At the same time, the sleeve 1010 attached to the pusher 1004, for example by a crimp 1014, is pushed together with the material. The portion of the sleeve 1010 that reaches the distal tip 1008 of the tube 1002 is folded toward the body 1006 of the delivery system 1000. As the sleeve 1010 reaches the knife 1012, it is optionally split so that it can pass over the tube 1002 and pusher 1004. A thread or wire or other connector 1013 is attached to the proximal (split) side of the sleeve 1010 (eg, via the connector 1019) and pulled through the pulley 1011 as the pusher 1004 advances. A slide 102 is optionally provided to guide the movement of the split sleeve.

  It should be understood that such a sleeve system can also be used to deliver a printing process rather than a material. In one example, a radially compressed (and axially expanded) compressed plastic, such as polyurethane implant, is advanced using a sleeve system to reduce friction. Optionally, the sleeve material is selected depending on the material and / or tubing used. In another example, a sleeve system is used to deliver a self-expanding implant, for example, as described in WO 00/44319 or WO 2004/110300, the disclosure of which is incorporated herein by reference.

  It is noted that the sleeve system can also be flexible. Optionally, the sleeve is formed from a chain or braid rather than an extruded plastic polymer tube. Optionally, the sleeve is formed from multiple layers of material, for example by extrusion or by lamination. Optionally, fibers or other reinforcing means are provided to prevent stretching. Optionally, the sleeve is formed from a material that resists heat and / or chemical byproducts generated by PMMA. Optionally, the sleeve is preformed to elastically expand when ejected from the delivery tube. Optionally, the sleeve is perforated or includes a plurality of holes.

  Optionally, the sleeve elutes one or more therapeutic materials. Optionally, the sleeve elutes one or more solvents that slow the material, eg, prevent or delay reaction in the delivery system and / or expedite drainage from the delivery system.

  Optionally, a layer of oil or other lubricant is provided in addition to or instead of the sleeve.

  Optionally, the sleeve is formed from, for example, a biodegradable material or remains inside the body while maintaining its shape. Optionally, upon decomposition, the reinforcing fiber or other element continues to increase the strength of the extruded material or implant.

  FIG. 10C is a cross-sectional view of a deformation system 1000 'that is flexible enough for the pusher 1004' to bend. This allows the body 1006 'of the device to be manufactured in a non-linear shape, for example in the form of a revolver that is easy to hold. Optionally, one or more wheels, bearings, or slides (not shown) are used to guide pusher 1004 '. Optionally, the pusher 1004 'can be made more flexible because some of the driving force used to move the material is provided by the sleeve pulling the material forward. Alternatively or additionally, some reduction is supported by reduced friction.

  Optionally, the sleeve system is used with a magazine system, eg, a providing unit via port 1016.

  Optionally, the sleeve is pre-divided and includes an overlap to prevent friction within the delivery tube. Optionally, this allows the magazine to load the sleeve from the side.

  FIG. 10D shows a further small variation 1000 "that is made sufficiently flexible that the pusher 1004" can be folded so that the body 1006 "can be sized smaller. Note that these smaller and / or non-linear embodiments can also be implemented without the sleeve function. The sleeve pullback mechanism is not shown here.

  FIG. 10E shows a deformation system 1000 ″ ″ with the axial size of the pusher 1004 ″ ″ reduced. In this design, propulsive force is provided by pulling back the cut sleeve 1010 using a knob 1040 (or by a motor or mechanical gain or other means). By this pulling back, the shortened pusher 1004 ″ ″ advances. Optionally, pusher 1004 ″ ″ is provided as a sealed end of sleeve 1010. Depending on the method of pullback on the knob 1040, the system body 1006 "" can be very small. Optionally, two or more symmetrically arranged knives 1012 are provided to provide proper mechanical support of the tube 1002 by the body 1006 '' '. Optionally, the tube is pre-cut.

  In an exemplary embodiment of the invention, it is noted that the pusher 1004 is separated from the infusion material by a sleeve. Optionally, for example (in FIG. 10F), a flexible tube is attached to pusher 1004 ″ ″ in tube 1002 and the pusher is advanced using a hydraulic system.

  In an exemplary embodiment of the invention, sleeve 1010 is used to separate the body itself from the hydraulic system, possibly in preparation for a system with a high probability of leakage.

  In the illustrated embodiment, material was discharged from the distal end 1008 of the tube 1002. Optionally, a stop is provided at the end so that the material is pushed to the side. Optionally, the stop is not attached to the end 1008 of the tube 1002. Rather, a single screw (or two or more threads) running in and / or outside the tube 1002 attaches the stop to the body of the device 1000. Optionally, the thread runs through a narrow lumen formed in pusher 1004.

  Alternatively, the element or elements that attach the stop to the tube 1002 serve to divide the sleeve at the tip 1008 of the tube 1002. In an exemplary embodiment of the invention, the stop is attached to the tube 1002 after the sleeve is attached to the tube. Alternatively, the sleeve is pre-divided and pulled through the tube 1002 through the element and attached to the connector 1019.

  In an alternative embodiment of the invention, the sleeve is provided entirely within the delivery tube. In one embodiment (not shown), the delivery tube includes two coaxial tubes, and the inner tube serves as shown by tube 1002 in FIGS. 10A-10E.

  In another embodiment, the delivery tube may be full of material because the material (316) serves to prevent the tube from collapsing when it is simultaneously extruded from one end and pulled from the other end. Be utilized. This may depend on the viscosity of the material and / or the shape of the distal tip of the delivery system. Optionally, the distal end is slightly widened to define a fold at the sleeve location.

  FIG. 10F shows such an embodiment of the delivery system 1050 with the sleeve 1010 provided within the delivery tube 1002. As can be seen, the folding position 1052 for the sleeve is provided through the end of the tube 1002. In an exemplary embodiment of the invention, a ring (not shown) is provided through the end of tube 1002 around which the sleeve is folded. This ring serves as a scaffold for folding, but has a diameter that is larger than the inner diameter of the tube 1002 (or is misaligned if the ring and / or tube cross-section is not circular), so retraction of the sleeve 1010 into the tube. I can't pull in.

  In an alternative embodiment of the invention, the sleeve 1010 does not fold toward the system 1000. Rather, the sleeve is pushed into the vertebra with the material. Optionally, once the material has gone out of range of tube 1002, it may tear the tube. In an alternative embodiment, the sleeve is kept intact and encapsulates the material in a sausage form within the body. The sleeve can be formed from a biocompatible, bioabsorbable, and / or implant grade material.

Providing material based on compression In an exemplary embodiment of the invention, the material is not extruded but rather squeezed out of the delivery system. FIG. 11A shows a squeeze-based system 1100 in which the delivery tube 1102 is made from a squeezable material such as a polymer or annealed metal. A pair of rollers 1104 (or a roller and opposing anvil, not shown) advances toward the distal side of the tube 1102 and squeezes it flat to displace the material filled in the tube in the distal direction. To extrude. A variety of motion mechanisms can be used. In the figure, the motion mechanism is a linear gear 1108 that engages a gear 1106 that is coaxial with the roller 1104. As the roller rotates, the linear gear advances the roller. Various power sources can be used, such as electric motors and hydraulic power. Other power trains can also be used. The roller is optionally made from stainless steel.

  FIG. 11B shows a delivery system 1120 where the squeezing element 1124 slides rather than rolling over the delivery tube 1122. Tube 1122 is optionally wrapped around pin 1134. Various mechanisms can be used to move the squeezing element 1124. For example, there is a motor 1130 attached to the cable 1126 via an optional pulley 1128.

Compaction Method In an exemplary embodiment of the invention, friction is mitigated by reducing the length of movement of the material inside the delivery tube. In one method, a small amount of material is provided distal to the delivery tube (while outside the body). The distal portion is then inserted into the body and a compaction device is provided in the proximal portion.

  This process can be repeated several times until the desired amount of material has been provided into the body.

Puncture delivery system In some embodiments of the present invention, the delivery system punctures and / or punctures bone. Optionally, this can eliminate the need for a separate cannula and / or simplify the procedure. Optionally, the delivery tube is maintained in the body when filling with the material to be injected.

  FIG. 12A shows a puncture delivery system 1200. Distal tip 1202 is formed to be suitable for drilling into bone. This is shown in more detail in FIG. 12B.

  A hydraulic pump or mechanical ratchet advance mechanism is optionally used. A handle 1206 is used for the illustrated pumping.

  A potential advantage of an integral system (one piece system) is that fewer parts are required. When the materials required for the system are loaded in advance, for example at the time of manufacture, no equipment replacement is required. Optionally, the use of side holes 1204 allows the tip to be a drill tip. Optionally, the use of a smaller diameter tube simplifies perforation, allowing fewer parts to be used.

  Optionally, the proximal end of system 1200 is adapted to tap with a mallet.

  FIG. 12C shows an alternative embodiment 1230 of the system. Here, the system is adapted to be mounted, for example, on K-wire. In the exemplary embodiment of the invention, a hole 1238 is formed in the drill portion 1232 of the system 1230. Alternatively, the hole is on the side of the drill head and exits through a hole 1234 that can also be used, for example, to extrude material. Optionally, a pusher (not shown) is also drilled. Optionally, the diameter of the drill hole is too small to get the material out. Alternatively, hole 1238 is used to extrude material after the K-wire has been removed.

  In an exemplary embodiment of the invention, the material is pre-drilled so that the guide wire can be passed through it. Optionally, this hole is provided with a sleeve. It is noted that without axial pressure on the material, the material generally does not flow into the drilled hole. Alternatively or additionally, the guidewire is coated with a suitable solid or fluid friction reducing coating.

  Optionally, the delivery tube is loaded after the delivery tube has been guided into the body (and the guide wire has been removed), for example using the barrel storage means or unit magazine described above.

  Optionally, a separate lumen is defined for the K wire. Optionally, the lumen is a collapsible lumen. However, it remains crushed until pressure is applied to the material to be delivered. Once the guidewire has completed its task, it is removed and pressure is applied to the material, collapsing the guidewire channel and improving flow characteristics (by increasing the effective inner diameter of the delivery tube).

  In an exemplary embodiment of the invention, a cannula is not required, for example when the delivery system rests on a guide wire or when the delivery system is used to puncture bone directly. Optionally, the delivery tube of the delivery system is removed once inserted into or into the bone using, for example, a barrel or pump mechanism as described above to reload the delivery mechanism, if necessary. It is not possible. Once the system is reloaded, the pusher can advance the material into the delivery tube and from there into the bone.

Optional Additional Therapies In exemplary embodiments of the invention, the material delivery is improved by additional therapies. Optionally, the additional treatment includes heat therapy. Optionally, the material is preheated or precooled. Optionally, preheating or precooling is also useful for controlling material properties and / or solidification behavior.

  In an exemplary embodiment of the invention, the heating is by contact heat (conduction) or by light, for example a flash lamp or a laser source. Alternatively or additionally, the delivery system radiates heat. Optionally, microwave or other wireless heating methods are used.

  Optionally, heating is accomplished separately from providing the material. In one example, a heated guidewire is provided in the vertebra. Optionally, the guidewire extends one or more protrusions to direct thermal energy to nearby tissue. Optionally, a thermal sensor is provided to control the temperature in the vertebra and / or prevent overheating.

Exemplary Materials A variety of materials are suitable for use in the exemplary embodiments of the invention. Some of the materials that can be used in some embodiments of the present invention are known materials, such as PMMA, but they can be used in exceptional conditions, such as in a semi-cured state. Putty materials are also known, but they are generally not used for injection into bone through small holes.

  Although specific examples are described, it should be noted that the material composition is often changed to achieve specific desired mechanical properties. For example, different diagnoses may suggest different material viscosities.

  In an exemplary embodiment of the invention, in the case of an uncured material, the material can be solidified outside the body. After such solidification, the material can be washed or vented. In this way, some materials with potentially harmful by-products can be safely mixed and then used in the body. Optionally, the material is tested to ensure that toxic by-products are removed below a safe threshold. Optionally, a test kit is provided in the delivery system.

  In an exemplary embodiment of the invention, the material is selected such that its mechanical properties match the bone in which it is implanted. In an exemplary embodiment of the invention, the material matches healthy cancellous bone or osteoporotic cancellous bone. Optionally, the mechanical properties of the bone are based on, for example, resistance to advancement, or using a sensor provided through a cannula, or by taking a specimen, or based on x-ray densitometer measurements. Measured during access.

  In general, PMMA is stronger than cancellous bone and has a higher modulus of elasticity. For example, cancellous bone can have a strength between 3 and 20 megapascals and a Young's modulus of 100 to 500 megapascals. For example, cortical bone has a strength value of 170-190 gigapascals and a Young's modulus of 13-40 gigapascals. PMMA generally has about half the value of cortical bone.

  In an exemplary embodiment of the invention, the material is selected to be less than 120% of the bone strength and / or Young's modulus expected to be treated. Optionally, one or both values of strength and Young's modulus are reduced by 10%, 20%, 30%, 40%, or less than that of cancellous bone. Note that if fewer vertebrae are filled, the injected material is partially supported by cancellous bone rather than cortical bone, for example, depending on the method of filling the interior 308.

Exemplary Non-Curing Material In an exemplary embodiment of the invention, the material used is a putty-like material. One example of a putty-like material is hydroxyapatite with an increased proportion of sodium alginate. For example, the ratio increase can be 8% or 10%. This material cures in the body but does not solidify into a cured state if there is no humidity. Thus, for example, the manufacturer can prepare it in advance and store it in the delivery system in advance. In an exemplary embodiment of the invention, the added material reduces the rate of water absorption so that enough water enters the material to initiate solidification, but not enough to cause dissolution. Let An example of this material is described in Ishikawa et al., “Non-decay fast setting Calcium phosphate element: Hydroxypayty putty contenting angi ter 3”, 39 The contents are incorporated herein by reference. For more details, see "Effects of neutral respirit het phen ate phen het phen ate sir te s s s s s s s s s s s s s s s s s s” s ”” ”Effects of neutral sten phen t”. J Biomed Mater Res 44, 322-329, 1999, the disclosure of which is incorporated herein by reference.

  Other calcium derived cements, bone chips, and / or fillers can also be used. Depending on the processing, bone chips may have a limited shelf life. Some of these materials typically harden (or combine with bone growth) after a relatively long period of time, such as 1 week or more, 1 month or more, or 3 months or more.

Additional Exemplary Uncured Material In an exemplary embodiment of the invention, the material used is a mixture of LMA (lauryl methacrylate) and MMA (methyl methacrylate). Depending on the ratio used, different mechanical properties and viscosities can be achieved. FIG. 13 is a graph showing the relative viscosity of PMMA and various proportions of copolymer. In the example shown, the viscosity decreases as the LCA ratio decreases.

  MMA and LMA diblock copolymers were synthesized by anionic polymerization using DPHLi as the starting material for THF with sequential addition of monomers at -40 ° C. The molecular weight distribution of the polymer was narrow and there was no homopolymer contamination when LMA was added to the chain end of living PMMA.

  In an exemplary embodiment of the invention, the ratio used is 80:20, 70:30, 60:40, 50:50, 30:70, 20:80, or a medium, smaller or larger ratio (volume ).

Experimental: Materials and Methods Starting materials Medicinal distillates stabilized with 10-100 ppm monomethyl ether of hydroquinone methyl methacrylate and lauryl methacrylate were used as received from Fluka, Germany. Benzoyl peroxide (BPO) was purchased from BDH Chemicals, UK. N barium sulfate (BS) was obtained from Sigma-Aldrich (Israel). All solvents were analytical grade from Biolab (Jerusalem, Israel) and were used as received.

Polymerization The polymerization reaction was carried out in a single neck round bottom flask equipped with a magnetic stirrer. In a typical reaction, 60 ml MMA (0.565 mol), 50 ml LMA (0.137 mol), 220 mg benzoyl peroxide (0.9 mmol), and 100 ml THF were transferred. The amount of BPO was adjusted to each of the composition components according to the total amount of moles of monomer. The amount of THF was equal to the total amount of monomer (Table I). The contents were heated to a polymerization temperature of 70-75 ° C. for 20 hours, then the solution was precipitated into a sufficient amount of methanol and mixed for 4 hours. Finally, the polymer was dried in a 110 ° C. oven under vacuum.

  The dried polymer was pulverized to a fine powder (Hishiangtai Sample mill, SM-1 type, Taiwan) and mixed with barium sulfate (30% w / w). The mixture was heated to 140 ° C. in the glass inside the sand bath until the polymer melted. The mixture was allowed to cool and ground again. This procedure was repeated at least three times until a homogeneous off-white polymer was obtained that could be melted into the loadable slag for the delivery system and magazine described above.

Evaluation A gel permeation chromatography GPC system consisting of a Waters 1515 gradient HPLC pump with a Waters 2410 refractive index detector and a Rheodyne (Kotati, CA) injector with a 20 μL loop (Waters, MA). Polydispersity was analyzed. The sample was eluted with CHCl ₃ through an Ultrastyragel column (Waters, 500 pore size) at a flow rate of 1 mL / min.

¹ H-NMR spectra were recorded on a Varian 300 MHz instrument using CDCl ₃ as the solvent. Numerical values were recorded as ppm relative to the internal standard (TMS).

  A Cannon 1C A718 Ubelhold viscometer was used to measure the viscosity of the polymer. The measurement was performed at 30 ° C. using toluene as a solvent.

Water absorption capacity The swelling behavior of acrylic bone cement was carried out from a precisely weighed film of 0.8 mm thickness. The film was introduced into a 0.9 wt% NaCl solution (20 ml) and maintained at 37 ° C. Water adsorption kinetics in 20 ml saline was evaluated with two samples of each bone cement (containing 30% barium sulfate).

The equilibrium gain was determined at various periods by gravimetry. Water absorption was recorded while increasing these intervals, initially at 30 minute intervals until equilibrium was reached. Samples were removed at appropriate times and wiped with absorbent paper to remove water adhering to the surface and weighed. The percentage of equilibrium gain was obtained from each sample using the following equation:

result:
100% PMMA: 1.845% on average (+0.045)
Initial weight (g): 0.2156 and 0.2211
Sample weight at equilibrium (g) 0.2195 and 0.2253
Balance gain (%): 1.8 and 1.89
60% PMMA, 40% PMMA: average 1.65% (+0.235)
Initial weight (g): 0.1161 and 0.1402
Equilibrium sample weight (g) 0.1183 and 0.1422
Balance gain (%): 1.42 and 1.89
50% PMMA, 50% PMMA: average 1.02% (+0.28)
Initial weight (g): 2700 and 0.2371
Sample weight at equilibrium (g) 0.2720 and 0.2400
Balance gain (%): 0.74 and 1.3

Compression tests These tests were performed at a crosshead speed of 20 mm / min using an Instron 4301 general purpose tester equipped with a 5 kN load cell. A known weight of polymer was melted in glass in a sand bath. The bath was heated to 150 ° C. for 2 hours, then barium sulfate was added (30% w / w) and mixed well several times until a homogeneous dough was obtained. A cylindrical sample having a diameter of 6 mm and a height of 12 mm was produced by pressing the molten copolymer into a Teflon-type hole. One side of the mold was covered with a Teflon plate and fixed with a clamp. The sample was cooled in the mold for 20 minutes, then the upper surface was cut into the shape of the mold, removed from the mold and finished into a complete cylindrical shape. Testing was performed after aging for at least 1 week at 23 ± 1 ° C. in air. Six samples were tested for each cement composition. Elastic modulus and maximum strength force were obtained.

Results Molecular Weight and Viscosity Measurements Number average and weight average molecular weights of poly (La-MA), poly (MMA), and their copolymers were obtained from gel permeation chromatography. The polydispersity index varies from 1.6 to 2.87. The viscosity of the polymer is obtained at 25 ° C. using toluene as a solvent. Intrinsic viscosity (η) was obtained by extrapolating η _spc ⁻¹ to zero concentration. Molecular weights and viscosities are presented in Table II.

Compression Test The results of the compression test are summarized in Table III as a function of compressive strength and modulus. The effect on the mechanical behavior of adding lauryl methacrylate monomer can be clearly observed. The introduction of a higher percentage produces a decline, which becomes more pronounced at 50% (v / v) LA. As the LA content increases, the compression modulus shows a dramatic decrease. This decrease may be related to the structural change of the matrix due to the introduction of LMA. This reduction may also limit the use of some compositions for some applications.

Material Change Optionally, various additives as described herein above are added to the material to change the properties of the material. Depending on the material, the addition can take place before solidification or after solidification. Exemplary materials that can be added include fibers of various lengths and thicknesses (eg, carbon nanotubes or glass fibers), aggregates, and / or bubbles.

  In an exemplary embodiment of the invention, if the material is manufactured to be anisotropic, for example, selecting a delivery route (eg, reservoir, tube, hole) to reduce twist and / or deformation Can be advanced into the body from a desired direction. Optionally, such material is provided as a short unit (Figure 8).

Softening and semi-curing materials In an exemplary embodiment of the invention, the material used softens after delivery into the body. In an exemplary embodiment of the invention, the material includes additives that disperse or embrittle in water or body fluid, eg, in salt. Softeners may be useful when the force required for height recovery is less than the force required to maintain height. Softening time is optionally controlled by incorporating a gel material that retards the penetration of water into the extruded material.

Semi-cured material In an exemplary embodiment of the invention, the material used solidifies into an uncured state. In an exemplary embodiment of the invention, the material includes MMA, LMA, and NMP. NMP dissolves in water and solidifies the material somewhat. In an exemplary embodiment of the invention, the stiffening state is avoided and possibly the induction of fractures in the nearby vertebra is prevented.

Use of Curing Material In an exemplary embodiment of the invention, the devices described above (eg, delivery) are used for materials that solidify to a hardened state, such as PMMA or other bone cements and fillers. In an exemplary embodiment of the invention, the material may have a timer and / or viscometer so that the operator can estimate the workability and viscosity of the material and its usefulness in restoring height without leakage. Provided in kit containing. Optionally, the timer mixed with the components of PMMA includes a temperature sensor to provide an estimate of workability time based on temperature and time.

  In exemplary embodiments of the invention, the solidified material will be highly viscous for a significant period of time, eg, 2 minutes, 4 minutes, 5 minutes, 8 minutes, 10 minutes, or intermediate or longer fractional working time frames. It is prepared as follows.

  In an exemplary embodiment of the invention, the following formulation is used: a set of beads formed from 10-200 micron diameter PMMA / styrene and an amount of MMA of 20 cc per 9.2 grams of beads. In an exemplary embodiment of the invention, the MMA changes solvate and / or encapsulates the beads, and the viscosity of the mixture is initially due to solvation changes and friction between the beads, and later of the progress of polymerization. Therefore, since the beads are dissolved, it is kept high. The beads can also be provided as a mixture containing a range of sizes. Note that the material properties can be selected to improve the viscosity work window, even if the final cement strength is compromised.

  In an exemplary embodiment of the invention, the working viscosity is set by selecting the bead size and / or material ratio.

Additional Implant Device Optionally, the implant is also injected into the vertebra, for example, before, during, or after material injection. Exemplary implants include metal or polymer cages or intraventricular devices, and an enclosing mesh or solid bag or balloon. Optionally, a bone graft is injected. Optionally, if an implant is provided, the material is extruded through the implant, for example, radially from its axial portion.

  Optionally, PCT / IL00 / 00458, PCT / IL00 / 00058, PCT / IL00 / 00056, PCT / IL00 / 00055, PCT / IL00 / 00471, PCT / IL02 / 00077, PCT / IL03 / 00052, And devices such as those disclosed in PCT / IL2004 / 000508, PCT / IL2004 / 000527, and PCT / IL2004 / 000923, the disclosures of which are incorporated herein by reference.

  Optionally, the material is extruded into a perforated cavity, eg, a cavity formed using an inflatable balloon. Optionally, the material is extruded into the intervertebral space, for example into the disc space.

  Optionally, a material that solidifies to a cured state, such as PMMA, is extruded simultaneously with a material that does not harden, or before or after. Optionally, the solidified material comprises less than 60% of the material, such as less than 40%, less than 20%, or an intermediate value.

Other Tissues and Overview Although the above applications focused on the spine, other tissues, such as compressed tibial plates and other bones with compression fractures, can also be treated, loosened implants, or implants during implantation It can also be used for tightening eg hip implants or other bone implants. Optionally, to tighten an existing implant, a small hole is drilled in the bone void where the material is pushed into the void.

  The use of the above methods and devices in bone is particularly advantageous in the case of bone, in particular vertebrae, but optionally to treat tissues other than bone, such as cartilage or soft tissue that require tightening. Please pay attention. Optionally, the material to be delivered comprises an encapsulated drug and is used as a matrix to slowly release the drug over time. Optionally, this is used as a means to provide an anti-arthritic drug to the joint, but a void is formed near the joint and an elution material is implanted.

  The implant implantation and treatment methods described above may include a sequence of steps, which steps are performed more frequently and which are performed less frequently, the arrangement of elements, the type and magnitude of the applied force, and / or It will be understood that various modifications can be made, including the particular shape used. In particular, various tradeoffs may be desirable, for example, tradeoffs between applied force and degree of resistance and tolerable force. Furthermore, the location of various elements, such as the arrangement of power supplies, can be exchanged without exceeding the spirit of the present disclosure. In addition, a number of different features of both the method and apparatus have been described. It should be understood that the various features can be combined in various ways. In particular, not all features shown above in a particular embodiment are required in all similar exemplary embodiments of the invention. Moreover, combinations of the above features are also considered within the scope of some exemplary embodiments of the invention. In addition, some of the inventive features described herein can be adapted for use in prior art devices in accordance with other exemplary embodiments of the invention. The particular geometric shapes used to describe the invention should not be construed as limiting the broadest aspects of the invention to only these shapes. For example, a cylindrical tube is shown, but in other embodiments, a rectangular tube can be used. Although some limitations are described as method or device limitations, the scope of the invention also includes devices programmed and / or designed to perform the methods.

  Also included within the scope of the present invention are medical devices suitable for implanting devices or materials and surgical kits including sets of such devices. The headings in the text are provided only to assist the guidance of the contents of the present application, and should not be construed to necessarily limit the contents described in a specific place to only that place. The measurements are provided to serve only as exemplary measurements for a particular case, and the exact measurements applied will vary from application to application. The terms “comprises”, “comprising”, “includes”, “including”, and the like, as used in the claims, include “including but not limited to” include but not. limited to) ”.

It will be appreciated by those skilled in the art that the present invention is not limited by what has been described so far. Rather, the scope of the present invention is limited by the claims.
The preferred embodiments of the present invention are as follows.
(1) (a) accessing the interior of the vertebra: and
(B) introducing a sufficient amount of an artificial biocompatible material that does not solidify into a cured state during storage with sufficient force to separate the fractured portion of the bone;
A method for treating vertebrae comprising:
(2) The method according to embodiment 1, wherein the material does not solidify into a cured state after introduction into the body.
(3) The method of embodiment 1, wherein the material can be stored for more than one day.
4. The method of embodiment 1, wherein the material softens after implantation.
5. The method of embodiment 1, wherein the material is partially cured after implantation.
(6) The method according to embodiment 1, wherein the material solidifies into a cured state after introduction into the body.
7. The method of embodiment 1, wherein the material does not solidify into a cured state during storage.
(8) The method according to embodiment 1, wherein the material is an artifact.
(9) The method according to embodiment 1, wherein the material is a plastically deformable material.
10. The method of embodiment 9, wherein the material has a hardness between 10 Shore A and 100 Shore A.
11. The method of embodiment 10, wherein the material has no higher cross-linking than Type I.
12. The method of embodiment 10, wherein the material is thermoplastic.
13. The method of embodiment 10, wherein the material comprises LMA (lauryl methacrylate) and MMA (methyl methacrylate).
(14) The method of embodiment 1, wherein the material is a viscous fluid.
15. The method of embodiment 14, wherein the material has a viscosity between 600 Pascal seconds and 1800 Pascal seconds.
16. The method of embodiment 1, wherein the introducing step includes introducing at at least 40 atmospheres.
(17) The method of embodiment 1, wherein the introducing step comprises introducing at at least 100 atmospheres.
18. The method of embodiment 1, wherein the introducing step includes introducing through a delivery channel having a diameter of less than 6 mm and a length of at least 70 mm.
19. The method of embodiment 1, wherein the introducing step includes introducing through an extrusion hole having a minimum diameter of less than 3 mm.
20. The method of embodiment 1, wherein the introducing step includes introducing through an extrusion hole having a minimum diameter of less than 1.5 mm.
21. The method of embodiment 1, wherein the introducing step comprises introducing through a plurality of extrusion holes simultaneously.
(22) The method according to embodiment 1, wherein the introducing step includes changing an introduction direction during the introduction.
(23) The method according to embodiment 1, wherein the introducing step includes changing an introduction position during the introduction.
24. The method of embodiment 1, wherein the material comprises at least one material adapted to function with a capability other than structural support.
25. The method of embodiment 1, wherein the introducing step includes advancing the material using a motor.
26. The method of embodiment 1, wherein the introducing step includes advancing the material using a hydraulic source.
27. The method of embodiment 1, wherein the introducing step includes introducing the material in discrete units.
28. The method of embodiment 27, wherein at least some units have mutually different mechanical properties.
29. The method of embodiment 1, wherein the introducing step includes detaching the material from the delivery system.
30. The method of embodiment 1, wherein the introducing step includes not twisting the material during the introducing.
31. The method of embodiment 1, wherein the introducing step includes forming an extruded shape of the material using an exit hole.
32. The method of embodiment 1, wherein the accessing step includes accessing using a guide wire and providing a delivery system over the guide wire.
33. The method of embodiment 1, wherein accessing comprises accessing using the material delivery system.
34. The method of embodiment 1, wherein the introducing step includes introducing without a separate void forming operation.
35. The method of embodiment 1, wherein the introducing step includes introducing without a spatially constraining enclosure.
36. The method of embodiment 1, wherein the introducing step includes introducing into a spatially constrained enclosure.
37. The method of embodiment 1, wherein the introducing step further comprises introducing a material that solidifies to a cured state of at least 10% by volume.
38. The method of embodiment 1, comprising selecting the material to have at least one hardness and Young's modulus properties lower than the cancellous bone of the vertebra one week after the implant.
39. The method of embodiment 1, wherein the introduced material acts to support at least 30% of the weight of the vertebra within one week from the implant.
(40) at least one instrument adapted to deliver material into the vertebra; and
At least 1 cc of artificial biocompatible preparation material that does not solidify into a cured state outside the body
Including surgical set.
41. The set of embodiment 40, wherein the at least one instrument includes a pressure delivery mechanism capable of delivering the material at a pressure greater than 100 atmospheres.
42. A set according to embodiment 40, wherein the set includes a disposable hydraulic actuator.
43. The set of embodiment 40, wherein the set includes a replaceable magazine for storing the material.
(44) (a) accessing the interior of the bone; and
(B) introducing a sufficient amount of biocompatible material into the bone without an enclosure between the material and bone, the introduction being performed with sufficient force to separate the fractured portion of the bone; ,
A method of treating bone comprising:
45. A method according to embodiment 44, comprising leaving the material in the bone to resist at least 30% of a normative force attempting to press the portions together.
46. The method of embodiment 44, wherein the bone is a vertebra.
47. The method of embodiment 46, wherein the material does not solidify into a cured state during storage.
48. A method according to embodiment 46, wherein the material does not solidify into a cured state in the body.
(49) (a) accessing the interior of the vertebra; and
(B) introducing a sufficient amount of a spatially unconstrained biocompatible soft material having a hardness of less than 100 Shore A into the vertebra with sufficient force to separate the fractured portion of the bone.
A method of treating vertebrae comprising:
(50) at least one instrument adapted to deliver material into the vertebra; and
A biocompatible preparation of at least 1 cc having a Young's modulus of less than 120% of healthy vertebral cancellous bone and prepared at least one day ago
Including surgical set.
(51) (a) accessing the interior of the bone; and
(B) introducing an unconstrained plastically deformable solid material harder than 10 Shore A and softer than 100 Shore A into the bone via a delivery tube.
A method of treating bone comprising:
(52) (a) a delivery tube having a lumen and a distal end adapted to be inserted into the body;
(B) a payload comprising at least one of a material and an implant within the lumen;
(C) a liner disposed between the tube and the payload; and
(D) a forward mechanism adapted to move the liner and the payload to the far end;
A device for delivering a material or implant into bone, wherein the liner reduces friction of the payload against the delivery tube.
53. The apparatus of embodiment 52 including a splitter that divides the sleeve.
54. The apparatus according to embodiment 52, wherein the mechanism pulls the sleeve.
55. The apparatus according to embodiment 52, wherein the mechanism pushes the payload.
56. The apparatus of embodiment 52, wherein the sleeve is folded over the delivery tube.
(57) A biocompatible material that does not solidify into a cured state, does not contain crosslinks greater than Type I, and is formed from MMA (methyl methacrylate).
58. The material of embodiment 57, wherein the material is formed from a mixture of MMA and LMA (lauryl methacrylate).
(59) A second medical use of PMMA for restoring vertebral height when applied directly to vertebrae.
60. The second medical use according to embodiment 59, wherein the PMMA is applied during solidification when the viscosity is greater than 400 Pascal seconds.
(61) A second medical use of a bone putty for vertebral treatment when applied into a vertebra through a tubular delivery system under pressure.
(62) (a) a first amount of beads having a set size; and
(B) Second amount of monomer
Wherein the quantity is selected such that the mixture of quantities obtains a solidified material having a workability time frame of at least 5 minutes with a viscosity between 500 and 2000 Pascal seconds, Polymerized composition.
(63) A method of treating bone, comprising providing a heat source in a vertebra in a controlled manner.
(64) (a) a head adapted to penetrate bone, (b) a hole adapted to push material into bone near said head; and (c) to deliver material to said hole. A composite device for accessing bone, comprising an elongate body with an adapted lumen; and a source of material under pressure.
65. The device of embodiment 64 comprising a guidewire lumen.
(66) a drill tool including a lumen;
A separable guidewire adapted to fit within the lumen; and
Handle adapted to control the relative position of the drill tool and the guide wire
A composite instrument for accessing the bone, comprising:

2 is a general flow diagram of a compression fracture treatment process according to an exemplary embodiment of the present invention. 4 is a more detailed flow diagram of a compression fracture treatment process according to an exemplary embodiment of the present invention. FIG. 6 illustrates a composite instrument for accessing vertebrae, according to an exemplary embodiment of the present invention. FIG. 2 shows the steps of an exemplary embodiment of the treatment method according to FIGS. 1A and 1B. 1 illustrates a basic material delivery system according to an embodiment of the present invention. 1 illustrates a basic material delivery system according to an embodiment of the present invention. Fig. 3 shows details of a material extruder tip according to an exemplary embodiment of the present invention. Fig. 4 shows an elongated curved extrusion of a material according to an exemplary embodiment of the invention. Fig. 6 shows a narrow lumen of a delivery system according to an exemplary embodiment of the present invention. 1 illustrates a hydraulic delivery system according to an exemplary embodiment of the present invention. 7B illustrates an alternative method of providing hydraulic power to the system of FIG. 7A, according to an exemplary embodiment of the present invention. 7B illustrates an alternative method of providing hydraulic power to the system of FIG. 7A, according to an exemplary embodiment of the present invention. 1 illustrates an exemplary hydraulic system including a disposable unit, according to an exemplary embodiment of the present invention. 1 illustrates an exemplary hydraulic system including a disposable unit, according to an exemplary embodiment of the present invention. Fig. 2 shows a cassette-based delivery system according to an exemplary embodiment of the invention. FIG. 4 is a detailed view showing delivery of unit elements according to an exemplary embodiment of the present invention. FIG. 6 illustrates a material pusher with reduced material twisting, according to an exemplary embodiment of the present invention. FIG. 6 illustrates a material pusher with reduced material twisting, according to an exemplary embodiment of the present invention. Fig. 5 shows a sleeve-based material pusher according to an exemplary embodiment of the present invention. Fig. 5 shows a sleeve-based material pusher according to an exemplary embodiment of the present invention. Fig. 5 shows a sleeve-based material pusher according to an exemplary embodiment of the present invention. Fig. 5 shows a sleeve-based material pusher according to an exemplary embodiment of the present invention. Fig. 5 shows a sleeve-based material pusher according to an exemplary embodiment of the present invention. Fig. 5 shows a sleeve-based material pusher according to an exemplary embodiment of the present invention. Fig. 3 shows a delivery system based on squeezing, according to an exemplary embodiment of the present invention. 1 illustrates a one-stage access and delivery system according to an exemplary embodiment of the present invention. 1 illustrates a one-stage access and delivery system according to an exemplary embodiment of the present invention. 1 illustrates a delivery system over a wire according to an exemplary embodiment of the present invention. 6 is a graph illustrating compressibility of a material according to an exemplary embodiment of the present invention.

Claims (12)

  In a surgical set,
  At least one instrument including a pressure delivery mechanism adapted to deliver material into the vertebra, the pressure delivery mechanism comprising:
  (A) a body including a piston and an input port;
  (B) a delivery tube connected to the body, through which the material is delivered to a patient's vertebra;
  (C) a hydraulic actuator connected to the body at the input port for delivering hydraulic fluid to the body under pressure to push the piston to deliver material in the delivery body to the patient's vertebrae; A hydraulic actuator comprising a piston and a correspondingly threaded cylinder, so that the hydraulic fluid can be pumped by rotation of the piston;
An appliance comprising: and
  At least 1 mL of artificial biocompatible preparation material housed in the delivery tube
With
  The pressure delivery mechanism may deliver the material at a pressure greater than 100 atmospheres (10.13 MPa);
Surgical set.   The surgical set according to claim 1, wherein the material has a Young's modulus of less than 120% of healthy vertebral cancellous bone when cured.   The surgical set according to claim 1, comprising a flexible tube extending between the actuator and an input port of the body.   The surgical set according to claim 1, comprising a pusher rod extending into the delivery tube, wherein the piston acts to transfer the material present in the delivery tube.   The surgical set according to claim 1, wherein the pressure delivery mechanism comprises a pump that provides a hydraulic gain of 1: 3.   The surgical set according to claim 4, wherein the pump comprises a pressure relief valve.   The surgical set according to claim 1, wherein the pressure delivery mechanism includes a cylinder and a piston, and includes a hydraulic oil-based pump mechanism having a pressure relief valve for preventing over-pressurization of the cylinder. Surgical set.   The surgical set according to claim 1, wherein the material is an acrylic bone cement.   The surgical set according to claim 8, wherein the acrylic bone cement comprises PMMA beads and MMA monomer.   The surgical set according to claim 9, wherein the size of the PMMA beads is 10 to 200 m.   The surgical set according to claim 10, wherein the PMMA beads are provided in a size range.   The surgical set according to claim 1, wherein the viscosity of the material is between 600 Pascal seconds and 1800 Pascal seconds for at least 5 minutes after mixing.

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