MXPA06002452A - System and kit for delivery of restorative materials - Google Patents

Abstract

Novel kits are provided for the delivery of restorative or injectable compositions into an intraosseous space or surgical defect comprising cannulae for accessing an intraosseous space, mandarins insertable into the cannulae and movable therein, one or more catheters and a system for the delivery of aliquots of restorative compositions into the space via catheters. Independant claims relate to the catheter having a high porosity tip (10) and to a microreamer having an expandable section comprising leaves that flex (13).

Description

SYSTEM AND KIT FOR THE SUPPLY OF RESTORATION MATERIALS Field of the Invention This invention relates to kit (s) for the delivery of restoration compositions in an intraosseous space, especially kit (s) that are useful in percutaneous surgical procedures such as percutaneous vertebroplasty. This invention is also directed to systems for the supply of aliquots of restoration compositions in a desired space especially by means of catheters. This invention is also directed to kit (s) to create a space within a vertebral body or intraosseous space within which a restoration composition can then be injected. The kit (s) may comprise needles / cannulae, stylets / mandrels, syringes and / or expandable reamers.

BACKGROUND OF THE INVENTION Percutaneous surgical procedures have become the front of the fields of orthopedic and neurological surgery, in an effort to limit tissue exposure, reduce operating time, accelerate recovery time and minimize scarring. in the patients. Percutaneous vertebroplasty is a procedure by which currently, cement Ref.: 170434 acrylic, typically polymethyl methacrylate ("PMMA") or a material such as the filling of holes for Cortoss® synthetic cortical bone (Orthovita, Inc., Malvern, PA ), is injected into the vertebral body by a percutaneous route in order to prevent the vertebral body from collapsing and pain in patients with unhealthy vertebral bodies. Percutaneous injection is minimally invasive compared to the alternative of exposing the soft and hard complete tissue at the surgical site. Percutaneous injection has also been indicated as a means of pain relief and restoration in patients with vertebral hemangiomas, painful vertebral body tumors as well as painful osteoporosis with loss of height and / or compression fractures of the vertebral body. See for example, Gangi, et al. Percutaneous Vertebroplasty Guided by combination of CT and Fluoroscopy, AJNR 15: 83-86, Jan 1994 ("Gangi"). All references cited in this specification are incorporated herein by reference. U.S. Patent Nos. 6,033,411 and 6,019,776 to Preissman, et al., Describe methods for a controlled method within a vertebral body, by inserting a sharp or threaded tip mandrel and a cannula percutaneously through the soft tissue of a organism until a protrusion of the soft tissue is formed, further inserting the mandrel at a predetermined location within the hard tissue; forming a ratchet with a blade mechanism or rotating a cam mechanism to advance the cannula along the mandrel to the predetermined location; remove the mandrel from the cannula and hold a source of implantable material for injection of the material into the organism through the cannula. U.S. Patent No. 4,838,285 to Strasser, et al. ("Stasser"), describes a bone biopsy needle assembly to remove samples of bone, bone marrow and other such fluids including a cannula and a stylet. The cannula and stylet handles are provided with features to couple reception when assembled together. In addition, both the cannula and stylet handles are comprised of two generally rectangular equal halves extending in diametrically opposite directions from the axis of the cannula. U.S. Patent No. 4,793,363 to Ausherman, et al. ("Ausherman"), discloses a bone marrow biopsy device that includes a cannula member and a stylet member with a Luer-type connector and a handle closure arrangement. US Patent No. 4,469,109 to Mehl ("Mehl"), discloses a bone marrow aspiration needle that includes a cannula, with a cannula housing supporting the cannula and a partially threaded lower limb, and a stylet with a stylet closure that supports the stylet and a threaded depth retainer to fit over the cannula. The US patent No.5, 601, 559 for Melker, et al. ("Melker"), describes an intraosseous needle having a threaded shaft with two lateral ports, which allows fluids to pass through the needle, and a tip having a plurality of cutting edges. Heini, P.F. et al., Percutaneous Transpedicular Vertebroplasty with PMMA: Operative Technique and Early Results: A Prospective Study for the Treatment of Osteoporotic Compression Fractures, Eur. Spine J. (2000) 9: 445-450 ("Heini"), discusses the use of various components to perform a percutaneous transpedicular vertebroplasty that includes a 2.0 mm K- wire to access the center of the vertebral body and a bone marrow biopsy needle placed on the K wire (which is subsequently removed) to place the needle. Heini also describes the use of standard 2-cubic centimeter syringes to inject the material through the needle. Gangi describes the percutaneous injection of PMMA into the vertebral body with the help of a CT and / or fluoroscopic guide using a needle and a 2 ml Luer lock syringe mounted on a pressure regulator to facilitate injection of the material.

Chiras, J., et al., Percutaneous Vertebroplasty, J Neuroradiol, 1997, 24, 45-59 ("Chiras"), describes cannulas of to 15 cm in length with a step of beveled edge and a diameter of 3 mm as it is a standard equipment for vertebroplasty. Deramond, H., et al., Percutaneous Vertebroplasty, Seminars In Musculoskeletal Radiology, Vol. 1, No. 2, 1997: 285-295 ("Deramond"), describes the use of various materials for percutaneous vertebroplasty ("PVP") which includes needles of ten gauge, 10 to 15 cm in length, with a bevelled end, fifteen gauge needles, 5 to 7 cm in length, with a flared tip, syringes with Luer connection of 2 to 3 ce, a handle of syringe and cement for bones. Deremond suggests that leakage can be avoided by injecting under lateral fluoroscopic control or inserting the cannula into the lateral part of the vertebral body. Jensen, ME et al., Percutaneous Polymethylmethacrylate Vertebroplasty in the Treatment of Osteoporotic Vertebral Body Compression Fractures: Technical Aspects, AJNR 18: 1897-1904, Nov 1997 ("Jensen"), describes the use of various components to carry out vertebroplasty including a 11-gauge Jamshidi needle and a stylet to gain access to a desired space, and both 10-ml and Iml syringes and an 18-gauge needle for injection of the material through the needle. Jensen, et al. teaches that the material should be left only if a leak should occur. In the art, if a leak is detected, the operator stops the procedure all together, continues with the injection of more material using a different batch of material, or allows the material that has already been injected to be thickened. Clinically, when using a different batch of material, it requires the surgeon to open another batch of material which is expensive and undesirable or practical in the case of standard restorative materials such as PMMA. Often in the case of a leak, the surgeon does not allow the material to be fixed, but rather waits until the material reaches a pasty stage (thickens) prior to the injection of more material. This method, however, prevents the surgeon from injecting the desired amount of material, since once the material becomes pasty, it has little time to work and must necessarily inject additional material prior to the material that is fixed in the cannula. If the material hardens in the cannula, the cannula will have to be removed and reinserted for additional doses. Surgeons are very skeptical about doing this because of the extreme difficulty of reinserting another cannula into the exact same place as the one that was removed. Even before the introduction of the restoration material, an operator may be interested in dislodging an existing portion of the cancellous bone, thereby creating a space that is ready for the procedures described above. The creation of a space in a vertebral body during the vertebral augmentation for the treatment of vertebral compression fractures (VCF) has generated an important interest as illustrated by the prolific use of instrumentation by quiproplasty. But this technique is imperfect in that the important pressures that are generated within the globe of quipotlasty can displace emboli of fat in the venous bloodstream, a phenomenon that could lead to pulmonary embolisms. It would be advantageous to create a similar cavity while minimizing the generation of pressure and displacement of the grease pistons. Another problem with inflatable balloons is that during inflation they follow the path of least resistance, so that if there is a break in the bone or in the final plate of the vertebral body, the balloon will form a hernia through the rupture, with which prevents further compression of cancellous bone. A solid compression device can eliminate this problem, since its shape remains inside the bone volume. It is an object of this invention to provide kit (s) for a minimally invasive delivery of the restoration composition in an intraosseous space. It is a further object of this invention to provide a solid compression device for creating or lengthening a cavity in a vertebral body or intraosseous space. The additional objectives, advantages and novel features of this invention, will become apparent to those skilled in the art upon examination of the following descriptions, figures and claims thereof which are not intended to be limiting.

Brief Description of the Invention This invention relates to combinations of devices and packaged kit (s) for the delivery of an injectable or restorative composition within an intraosseous space. These comprise one or more cannulas adapted to access the intraosseous space, one or more stylets / mandrels that are inserted into the hollow cavity of the cannula and that move therein to advance the cannula into position. These are adapted to access the intraosseous space. The kit (s) and systems also preferably have one or more catheters that are inserted into the cannulas, stylets that are dimensioned to fit within the catheters to advance through the material, and a system for the delivery of aliquots of injectable composition or of restoration within the intraosseous space by means of catheters. The kit (s) may also include a micro-reamer that fits within the hollow cavity of the cannula (after removal of the stylet and before insertion of the catheter) or to make a channel for the delivery of material by means of the catheter. Fixed to the proximal end of each cannula, stylet and micro-reamer, there is a substantially lateral surface (flat, solid knob, or pedestal) with response to shock movements. The cannula, micro-reamer and catheter may also include stagings. The catheter may also comprise a single distal opening, or a plurality of openings along some portion of its distal region. The kit may also include a device for the creation or augmentation of a cavity in a vertebral body or any metaphyseal bone area, a description of a modality of such a device appears below. Some catheters of the present invention may have a distal end, and at least one positioning hole disposed proximal to the distal end, wherein the positioning hole may be adapted to dose the injectable or restorative composition directly from the distal end or radially. from it. Such adaptation may include partially covering the distal end with a high porosity material to achieve multi-directional diffusion of the restorative or injectable material. The catheters used in the kit (s) may comprise stainless steel, polyimide, latex, silicone, vinyl or other suitable polymer in the art. They can be flexible for maneuverability and be long and of such material that they can be cut to size at the time of use. The kit (s) may also preferably comprise a plurality of syringes having an opening at a distal end that provides a fluid conduit lengthwise, from a hole that engages within the opening, as well as a closure mechanism such as a type of Luer lock of the closure mechanism, to couple a proximal end of the catheter to dose the material into the space through the catheter. In a preferred embodiment, the kit includes a plurality of syringes including syringes of 1 cc, 3 cc and 5 cc. The invention also relates to a system for the delivery of a restoration or injectable composition for a specific intraosseous space wherein the aliquoting of the restoration or injectable composition is under the tactile feedback control of a human operator such as a surgeon or interventionist. The restorative or injectable composition may comprise a hydrogel, synthetic bone hollow filler, polymethyl methacrylate, or replicate bone marrow. The present invention also relates to kit (s) for the delivery of injectable or restorative compositions comprising at least one cannula, at least one stylet, at least one catheter comprising a high porosity tip, and a system for delivery of aliquots of the injectable or restoration composition in the intraosseous space by means of the catheter. High porosity tips may comprise polylactic acid and may be biocompatible, bioreabsorbable and / or bioactive. The tips can be partially coated with a non-porous or semi-porous material. Additionally, the kit (s) of the present invention may comprise an expandable micro-reamer to create or augment a cavity in a vertebral body or intraosseous space. This micro-reamer can comprise an expandable cylindrical section that can be placed through a cannula or tube that is placed inside a vertebral body or intraosseous space. The expandable cylindrical section is in combination with the outer shaft and surrounds an inner shaft. The cylindrical section can be moved to effect tamping or cutting. In one embodiment, the cylindrical section once compressed expands to create an ovoid shape. The size of the ovoid shape created depends on the aspect ratio and volume of the expandable cylindrical section. As defined herein, the aspect ratio is the ratio of the expanded height divided by the expanded width. The kit (s) of the present invention can include multiple micro-reamers that expand to create various defect sizes.

In another embodiment, the micro-reamer rotates to effect cutting. The expandable section may comprise an elastic metal, a metal compound, a polymer or a suitable material known in the art that can expand and recover its original shape. One embodiment of the expandable section may comprise nitinol. The location of the expandable cylindrical section along the length of the micro-reamer may vary, alternatively the length of the micro-reamer itself may vary to provide the user with a device that can be placed on bones and defects of all sizes . This invention also relates to combination of device and packaged kit (s) for the creation and augmentation of a space in a vertebral body or intraosseous space and for the delivery of a restorative or injectable composition within such spaces. Such kit (s) may comprise an expandable miro-reamer and an element for tamping bones, one or more cannulas adapted to access the intraosseous space, one or more stylets / mandrels that are inserted into the hollow cavity of the cannula and internally, at least one catheter that is inserted into the cannulas, and a system for supplying aliquots of the injectable or restoration composition within the intraosseous space by means of a catheter.

Brief Description of the Figures Figure 1 details a kit of one embodiment of the present invention showing a cannula and a stylet, a micro-reamer and a plurality of catheters and syringes. Figures 2 and 2A detail one embodiment of the present invention with a specialized distal end with a plurality of openings. Figure 3 details a closing mechanism of the stylet cannula. Figure 4 details an alternative embodiment of the tip of the stylet. Figure 5 details a kit of the present invention showing a plurality of catheters and syringes. Figure 6 details the lateral opening characteristic of certain preferred catheters of the present invention. Figure 7 details a front opening catheter / cannula having a micro-reamer feature. Figure 8 details a lateral opening catheter having a micro-reamer feature. Figure 9 details a shape memory mode of the catheter / micro-reamer. Figures 10 and 10A detail a fitted catheter with a diffusing tip of high porosity. Figure 11 details certain preferred syringes of the kit of the present invention. Figures 12A-12B detail the cylindrical section of the expandable micro-reamer. Figures 13A-13B detail the expanded sheets of the cylindrical section in angled and parallel formations. Figures 14A-14B detail the expandable micro-reamer with the compression knob.

Preferred Modes The present invention provides kit (s) for the delivery of an injectable or restorative composition. Typically, kit (s) such as the kit shown for example, in Figure 1, comprise at least one cannula 10 or needles. More typically, the cannula is adapted to access the particular intraosseous space. According to one embodiment, the cannula 10 is in a caliber of 5 to 14 or preferably in a gauge needle of 11 to 12 having a solid handle 15 for absorbing the impact and force with the insertion in the bone, and a hollow hole component 20 placed thereto. The handle 15 is shaped asymmetrically to accommodate a user's hand and includes a space 16 for receiving the unidirectional stylet / mandrel 11 (or other instruments). One or more stylets 11 adapted to have access to an intraosseous space are preferred in some embodiments.

Typically the stylet 11 comprises a solid knob or head 18 that is conical in shape for easy insertion and removal in the receiving space 16 of the handle 15 of the cannula 10, and an elongated solid rod 22 with a bevelled tip 19 (for turning capabilities) or diamond tip 31 which sits within the hole 20 of the cannula 10 when in use (see for example figure 4). The unidirectional adjustment allows a bolt 9 inside the knob 18 of the stylet 11 to be closed within a corresponding recess 17 on a handle 15 of the cannula 10 (see for example Figure 3). Specifically, the coupling occurs when the pin 9 of the stylet 11 moves simultaneously in the upper / lower direction and rotates in the recess 17 of the handle of the cannula 15. This adjustment ensures that the stylet is always correctly positioned thus creating a solid sharp bevelled tip 19 or a diamond tip 31. The cannula 10 and the stylet 11 are used to gain access in the body cavity. Force is used either for screwing or closing to drive both the cannula 10 and the stylet 11 into the bone space. Once the space is accessed through the cannula 10 and stylet 11 in some preferred embodiments, the stylet 11 is removed and a micro-reamer 12 is inserted to create space or an opening in the bone for placement of the restoration composition. or injectable. The micro-reamer 12 conveniently has a knob 8 similar to that of the stylus knob 18 but without a bolt engaging within the needle lock. The absence of the bolt allows the operator to insert and rotate the micro-reamer 12 around the space. In many forms of this invention, the micro-reamer 12 is used to create a channel which facilitates the insertion of the catheter (and subsequently the supply of material). The rotation of the micro-reamer 12 creates some debris that helps block the venous trajectories and thus reduces the potential for leakage. In other forms of this invention, the micro-reamer 12 is fitted with a cutting means 6. The axis 7 of the micro-reamer 12 is generally longer than the axis 20 of the cannula. It may extend from about 1.0 cm to 3.0 cm (and all combinations and subcombinations of specific ranges and volumes therein) out of the distal tip of the cannula 10 when it is fully inserted. Typically, the length of the second axis of the catheter is about the same in length to the length of the microreactor 12 when it is inserted completely into the cannula. Micro-reamers of varying lengths can be used depending on the method an operator uses to access an intraosseous space. In certain embodiments, when there is access to a vertebral space, the tip of the cannula 10 remains in the interior opening of the bone while the elongate micro-reamer 12 has access to the opposite cortex of the vertebral space. In other embodiments, the micro-reamer is formed, folded or made from a shaped memory material that allows for additional bending, so as to create a larger channel space for the catheter. Once the microreactor 12 creates a space for the material, it is removed from the cannula 10 and replaced with a catheter 13. The catheters are used to deliver the restoration or injectable composition into the intraosseous space. Another embodiment of the catheter may comprise a plurality of openings 96 (see Figure 2) to achieve radial or multi-directional dispersion of a restoration composition. The multi-directional dispersion allows the human operator to achieve a uniform release of a restoration material. Figure 2 details a catheter 13 with a plurality of openings 96, which may allow a multi-directional distribution of the restorative or injectable material within an intraosseous space. The opening amount 96 may vary to adjust the selected types of restorative or injectable materials or different methods for their delivery, for example, to affect a particular injection rate. The openings 96 may be of uniform or variable shapes and sizes and may be placed uniformly or irregularly along the catheter 13. For example, the openings in the distal tip of the catheter may be smaller than those nearest (or vice versa) to guide the flow of material in such a way as to prevent leakage of material away from the bone site. A preferred embodiment may comprise a set of elliptical openings, configured uniformly along some portion of the length of the catheter 13 (see Figure 2, detail A). In a specific embodiment of this invention, a front opening catheter 43 (see FIG. 5) is supplied for delivery, and in another embodiment, a lateral opening catheter 50 (see FIG. 6) is provided for the radial delivery of the composition. inside a bone space. The front opening allows direct injection of material into the site through the opening in the distal tip. The lateral opening catheter 50 is useful for the radial delivery of the composition into a bone space as it allows a 360 ° directional control of the supply of the restorative or injectable materials. In a further embodiment, the distal end of the catheter may have a high porosity tip 98 (see Figure 10), or a directional diffuser. The catheter with diffuser tip can be adjusted through the cannula. As used herein, "high porosity" means that it has a porosity in the range of 60% to 99%. The composition flows through a plurality of pores 100 of the directional diffuser 98 when the operator applies the injection pressure. The directional diffuser 98 allows a uniform multidirectional supply of a restorative or injectable material. The directional diffuser 98 in the catheter can also contribute to the operator's ability to ensure that the proper amount of the restoration or injectable composition is injected into the selected intraosseous space. The risk of introducing excess material into the intraosseous space and the surrounding areas is thereby reduced. The directional diffuser 98 may preferably comprise an open-cell polylactic acid (OPLA®), a scaffold of a synthetic polymer that is synthesized from the D, D-L, L-polylactic acid, but which may be any suitable high-porosity material. Since polylactic acid is biocompatible and can be reabsorbed, a tip of the diffuser comprising this material can be left in or near the intraosseous space following the injection of the restorative or injectable composition. As used herein, "biocompatible" means that the material does not invoke an inflammatory response when it contacts body fluids of mammals and tissues. Alternatively, the tip of the diffuser 98 can be removed along with the catheter after injection. The diffuser may be partially coated with a semi-porous or non-porous material 102 to control the direction of flow. The semi-porous or non-porous material may comprise a low porosity polymer ceramic compound such as PLLA / β compound tricalcium phosphate or may include a biocompatible polymer, ceramic or metal such as titanium. The semi-porous or non-porous material may also be biocompatible or re-absorbed. In typical embodiments, the catheters also include gradients or gradients 40 along the axis to further assist in the delivery of the composition. These gradients 40 help in determining the volume of the restoration or injectable composition that is injected, and also the depth of the catheter within the space. Typically, the gradients 40 are placed at variable lengths suitable for each procedure and may be internal markings or external projections. More typically, these gradients 40 become 1 cm apart and are external markers. The catheters of the present invention can be of varying volumes and lengths. It is appreciated that the distance of the microreactor 12 extending out of the distal tip of the cannula 10 will vary depending on the nature of the space to which one has access. Generally, catheters comprise metals such as stainless steel or titanium, which are rigid and easily visible by X-rays, but may also comprise a plastic or polyimide which can serve as a flexible element, latex, silicone, vinyl, or polymers different from those listed here or from a ceramic material. In other embodiments of the invention, the catheters comprise nitrinol or any other alloy with "shape memory". In this way, the shape memory catheter 80 (or a micro-reamer with shape memory) can be placed through the cannula 20 within a structure, either an implant structure 85 or anatomical structure with known openings. , 88, which pass through the catheter or shape memory for a directional and accurate supply of the material (see for example figure 9). Still in more modalities, the catheter is flexible for maneuverability and such material that it can be cut to size at the time of use. According to a specific embodiment of this invention, the catheter 13 has a knob 41 having an adapter 41a for connecting to a syringe tip such as a Luer connection and a hollow shaft 42 extending therefrom (see figure 5) . In some preferred embodiments, the catheter may be long (at a distance from the surgeon or the user from any source of radiation that may be used during the surgical procedure). In other embodiments, the catheter has 2 consecutive axes with one that has a plunger mechanism and the second axis that engages the distal end of the first axis by means of a Luer connection and other closure means better equipped to ensure the lack of leakage of the restoration or injectable composition. In a specific embodiment, such as the embodiment detailed in Figure 7, the catheter is provided with projections or cutting elements at its distal end 44. In this manner the catheter acts as both a micro-reamer and a catheter. This feature can be added to both the front opening catheter 43 (see figure 7) and the lateral opening catheter 50 (see figure 8) in the modalities. More specifically when it is added to the side opening catheter 50, the cutting means 60 is placed at the distal end 44 so that the opening 61 (with the removal of the stylet 11) is closer to the handle than the cutting means 60. When is added to the front opening catheter 43, the cutting means 60 is closer to the handle than the opening 61. While in use, the stylet 11 is held in place during the micro-reaming aspect of the procedure, and then withdraw for the injection of the material. The cannula of the present invention can also be provided with means for cutting in the same manner as the front opening catheter. By supplying kit (s) with a catheter, the present invention overcomes the situation in which a procedure is stopped due to leaks, the material hardens in the cannula and the cannula must be removed and replaced, or the situation in which the material thickens and becomes difficult to inject. In many embodiments, kit (s) of the present invention are provided with a plurality of catheters which fit through the cannula. Once the material hardens, the first catheter is simply removed with the cannula in place and a new catheter slides into place for the next dose. Typically, the cannula never has to be removed and the operator does not run the risk of trying to reinsert the cannula in the exact same place. In a modality such as the embodiment shown in Figure 11, a syringe 14 is placed on the catheter for delivery of the material. Typically, various syringes are provided with the kits (s) of the present invention including standard syringes for example 1c, 3c and 55. More typically, the syringes have an opening 93 at one end for supplying a fluid conduit through a syringe. orifice 95 that engages within the opening 93, and a plunger 94 that seats within the barrel 91 of the syringe 14. The material to be injected (not shown) is placed in the barrel 91 of the syringe 14 and then the plunger 94 is placed inside the 91 barrel for the extrusion of the material. The opening 93 may be a Luer lock type mechanism for coupling the proximal end of a catheter to inject the restorative or injectable material into the space. In a preferred embodiment of the present invention, the syringes of 1c, 3c and 5c, are specially designed in such a way that the diameters of the respective pistons 94, and the internal diameters of the respective barrels 91 are reduced, but are both of the same size for each of them. the sizes of syringe 1 ce, 3 ce and 5 ce. Since the internal diameters of the barrels 91 of each of the syringes of different size is equal, the differences in volume between the syringes are compensated for by increasing the length of the syringe 14 in its barrel with an increasing syringe size. The amount of force required to inject the material through the syringes of the present invention is generally reduced in each individual syringe since the cross-sectional area is reduced and the internal diameter of the barrel 91 and the diameter of the orifice 95 they are coupled closely. To further reduce the force required to move the material through the syringe in a preferred embodiment, there is a gradual decrease in the diameter of the barrel 91 (internal) at the tip of the syringe to the orifice 95. This gradual decrease improves much better the flow of material through the hole. These syringes differ from those of the prior art in that the internal diameters of the plunger / barrel (and therefore the cross-sectional areas) of the prior art is increased with increasing syringe size. Since the diameter of the orifice does not change with the increasing size of the syringe, increasing force (due to increasing resistance) is required to inject the material through the orifice as the volume / size of the syringe increases. When the larger syringes (5 cc) are used to inject viscous material that tends to thicken over time (in order to settle), it is not common for prior art syringes to rupture with forced extrusion / injection of the material. The kit (s) of the present invention are designed to adequately and accurately deliver a restorative or injectable composition within an intraosseous space such as a human vertebra when the composition has a very mobile rheology. In general embodiments of this invention, after the operator creates a space or opening in the bone for the composition, the intraosseous space is increased with a restoration or injectable composition. The increase begins with an initial containment that is created by a small dose of composition through the catheter. This containment is created to avoid additional doses of material from flowing out of space due to a very mobile rheology. The containment is allowed to cure, the catheter is replaced, and then a second aliquot of the restoration or injectable composition is added to the containment as necessary. This aspect of the invention ensures that all openings are sealed with the leak prevention composition. Once the second aliquot of the composition has been cured, additional aliquots of the composition can be injected by means of an additional syringe containing an additional aliquot of material so that the space or opening is completely filled. It will be appreciated that additional aliquots will not be necessary for all procedures. Unlike the prior art, an operator using the present invention can routinely establish a containment of the material, allow it to harden and then inject additional doses of material when replacing the catheter. The systems of the present invention particularly accommodate for mixing in on-demand supply systems using a supply gun and a mixing tip. In typical embodiments, the kit (s) of the present invention characterizes a tactile feedback control. When a composition is supplied in a vertebra, the cannula 10 is generally inserted substantially close to, but not against, the anterior wall. Some distance between the cannula 10 and the wall is necessary so that the micro-reamer 12 can create a channel.

For those embodiments that characterize catheters with a lateral opening 50, the composition is radially dispersed in space even if the distal end of the catheter is in contact with the anterior wall. In other embodiments, the syringes of the present invention exemplify tactile feedback control by allowing the user to apply a constant force regardless of the inserted volume. The kit may also include stylets that are sized to fit within the catheter to advance material through the catheter and purge any residual material that remains inside the catheter. Various restorative or injectable compositions can be used within the systems of the present invention. The type of composition used depends on the procedure to be carried out. In some embodiments, the system includes the injection of a plurality of materials including hydrogels, fillings for voids of synthetic bones, polymethylmethacrylate, or replicated bone marrow. In a general mode, the system is a syringe filled with the material. Specifically, the system is a prefabricated system of material that is injected directly into the syringe or catheter. In another embodiment, the system for delivery comprises a single syringe. Once the channel is created with the micro-reamer 12, the catheter is inserted into the cannula 10 at the same depth previously occupied by the micro-reamer 12. A small amount of restorative or injectable material, between approximately 0.1- 1.5 cc, is injected slowly into the catheter by means of a syringe filled with restorative or injectable material under fluoroscopic control while some venous leakage is verified. The catheter can be easily visualized under fluoroscopy either by the use of a radiopaque material or by adding an agent to the material that makes the radiopaque material. If a venous leak occurs, the injection is immediately stopped, and the catheter is withdrawn from the cannula 10 while the cannula remains in place. In this way, the access port to the vertebra remains open. After waiting for an adequate amount of time for example between 2 to 4 minutes, a new catheter is inserted and the injection is resumed. If another venous leak occurs, the same procedure is repeated. Once there are no more venous leaks, the right volume of material is injected. This technique allows someone to make optimal use of a blending feature at the request of a restorative or injectable material, place the desired amount of material on the site and eliminate the haste of the procedure due to concerns of depositing the material in the cannula Some embodiments of the present invention may include an expandable micro-reamer 104 (see Figure 14). This expandable micro-reamer 104 can be used to create or augment a space within a vertebral body or other intraosseous space. Such glimpsed space can be areas of metaphyseal bone such as the distal radius, proximal humerus, proximal femur, distal femur, proximal tibia, distal tibia, calcaneus, or talus. The expandable microreactor 104 comprises an expandable cylindrical section or bone plug 106 which is in communication with an outer shaft 108 surrounding an inner shaft 103 of the microreactor. The ramming member 106 has blades 112 that are formed by the slots 114 along the length of the cylindrical section. The blades 112 flex outwardly or in the opposite direction of the inner shaft 110 when the bone tamping section 106 acts on the outer shaft 108. The ramming member 106 may comprise an elastic metal such as nitinol or other composite material /polymer. As the leaves 112 flex, a space or cavity can be formed through compaction or compression of the surrounding bone or tissue. Restorative or injectable compositions, synthetic bone (allograft or autograft) or cement may be among the compositions injected into space. The ramming element 106 can act by rotating a compression knob 116 which is in communication with the outer shaft 108. The compression knob 116 can be formed with ribs or otherwise textured to facilitate rotation. The sheets 112 of the element for tamping the bone 106 can be formed from grooves in the cylindrical section a - along the length of the cylinder as illustrated in Figure 12. In another embodiment, the blades 112 of the ramming element 106 can be formed from the grooves that are at an angle to the longitudinal axis of the cylinder. As defined herein, the longitudinal axis is an imaginary line running centrally along the length of the cylinder from one end to the other. The angle of the slot relative to the longitudinal axis can be from 5 degrees to 30 degrees and more preferably from 10 degrees to 15 degrees. This configuration results in a minimal residual deformation since during the expansion the deformation near the midpoint of the component is less exaggerated than in the longitudinally grooved version. This embodiment, wherein the blades are at an angle to the length provides a device that flexes easily and deforms back to its original shape to present a uniform appearance. In this way, the micro-reamer can be easily inserted as well as easily removed from the cannula when desired. The blades also expand and form an expansion angle with the cylindrical body when the micro-reamer is driven. The size of the created space will be directly proportional to the expansion angle in any mode. There is a direct relationship between the angle of expansion and the space created. This means for greater bone compaction. The expansion angle can vary in size based on the desired size of the space to be created and will be affected by the folding ability of the material, thickness of the sheets and the like. An operator can compress the bone using the element to tamp the bone or it can rotate the element to tamp to cut the bone. The outer flexing or expansion of the sheets 112 broadens the spaces between the sheets 112 and creates an area within which fluids and grease pistons can flow instead of causing these substances to move in the venous bloodstream as it happens with the use of the chemoplasty balloons. A space can be formed by flexing the sheets 112 by rotating the compression knob 116, then retracting the sheets 112 by turning the knob 116 in the opposite direction, rotating the element to tamp the bone 106, and then expanding the sheets 112. A The operator may cut the bone or other tissue by rotating the element to tamp the bone 106 while the leaves 112 are in a partially or fully expanded state. Bone or tissue material that has been released from the matrix of cancellous bone matrix can then be compacted or compressed against the wall of space by contracting and expanding the element to tamp bone 106. The size of the created space depends on the capacity of folding the material and the thickness of the sheets as well as the aspect ratio of the expandable cylindrical section in an expanded space and the volume of the expandable cylindrical section in an expanded state. Once a space has been created or augmented by the element to tamp the bone, the restorative or injectable material can be added. The stepping in the cannula 10 which is used to insert the micro-reamer 104 can also help the operator to deliver the material. Those skilled in the art will appreciate that various changes and modifications can be made to the preferred embodiments of the invention and that such changes and modifications can be made without departing from the spirit of the invention. It is therefore intended that the appended claims cover all such equivalent variations when they fall within the spirit and real scope of the invention. It is noted that with this date, the best method known to the applicant to carry out the practice of said invention, is that which is clear from the present description of the invention.

Claims (44)

Claims Having described the invention as above, the content of the following claims is claimed as property.

1. A kit for administering a composition in an intraosseous space characterized in that it comprises: at least one cannula; at least one stylet that is inserted in the cannula and that moves in it; at least one catheter having a high porosity tip that is inserted into the cannula; and a system for the administration of aliquots of the composition in the intraosseous space by means of the catheter.

2. The kit according to claim 1, characterized in that the catheter is divided into graduated marks.

3. The kit according to claim 1, characterized in that the high porosity tip comprises polylactic acid.

4. The kit according to claim 1, characterized in that the high porosity tip is partially covered with a non-porous or semi-porous material.

5. The kit according to claim 4, characterized in that the material is a ceramic polymer or metal.

6. The kit according to claim 5, characterized in that the material is calcium phosphate, PLLA, or titanium.

7. The kit according to claim 4, characterized in that the material is biocompatible or resorbable.

8. The kit according to claim 1, characterized in that the high porosity tip is biocompatible or resorbable.

9. The kit according to claim 1, further characterized in that it comprises a catheter with a plurality of openings near the distal end.

10. A kit for the administration of a restoration or injectable composition to an intraosseous space or a surgically created bone defect, characterized in that it comprises: a micro-reamer comprising an expandable cylindrical section in communication with an exterior axis, the exterior axis and the section expandable both surround an internal axis, the expandable section comprises leaves that flex when the expandable section is activated to create a space for the composition; at least one cannula to access the intraosseous space or defect; at least one stylet insertable into the cannula and moving therein; at least one catheter that is inserted into the cannula; and, a system for administering aliquots of the composition in the intraosseous space by means of the catheter.

11. The kit according to claim 10, characterized in that the expandable section comprises an elastic metal, a composite material, a polymer, or another appropriately expandable substance.

12. The kit according to claim 10, characterized in that the expandable section comprises nitinol.

13. The kit according to claim 10, characterized in that the outer shaft provides the means for expanding the expandable section.

14. The kit according to claim 10, characterized in that the outer axis is divided into graduated marks.

15. The kit according to claim 10, characterized in that the catheter has a distal end and at least one positioning hole disposed close to the distal end; the placement hole is adapted to deliver the composition radially from the catheter.

16. The kit according to claim 10, further characterized in that it comprises a screw with a cannula.

17. The kit according to claim 10, characterized in that the stylet, micro-reamer, or cannula, all have a proximal end and a distal end and a lateral surface that responds to an impact murmur, is fixed to the proximal end.

18. The kit according to claim 10, characterized in that the catheter comprises stainless steel.

19. The kit according to claim 10, characterized in that the catheter comprises polyimide.

20. The kit according to claim 10, characterized in that the catheter comprises latex.

21. The kit according to claim 10, characterized in that the catheter comprises silicone.

22. The kit according to claim 10, characterized in that the catheter comprises vinyl.

23. The kit according to claim 10, characterized in that the catheter comprises a shape memory material.

24. The kit according to claim 10, further characterized in that it comprises one or more syringes that have a Luer lock.

25. The kit according to claim 10, characterized in that the cannula is divided into degrees, the degrees are marked.

26. The kit according to claim 10, characterized in that the micro-reamer is divided into degrees, the grades are marked.

27. The kit according to claim 10, characterized in that the catheter is divided into degrees, the degrees are marked.

28. The kit according to claim 10, characterized in that the composition comprises a hydrogel.

29. The kit according to claim 10, characterized in that the composition comprises a synthetic bone vacuum filler.

30. The kit according to claim 10, characterized in that the composition comprises polymethyl methacrylate.

31. The kit according to claim 10, characterized in that the composition comprises replicated bone marrow.

32. The kit according to claim 10, characterized in that the composition comprises replicated bone marrow.

33. A micro-reamer for creating an intraosseous space, characterized in that it comprises: an expandable cylindrical section in communication with an outer axis, the outer axis and the expandable section both surround an internal axis, the expandable section comprises leaves that flex when the expandable section is activated to create a space for a restoration or injectable composition; wherein the sheets are located along the length of the cylindrical section.

34. The micro-reamer according to claim 33, characterized in that the expandable section comprises an elastic metal, a material in composition, a polymer, or another appropriately expandable substance.

35. The micro-reamer according to claim 33, characterized in that the expandable section comprises nitinol.

36. The micro-reamer according to claim 33, characterized in that the outer shaft provides the means for expanding the expandable section.

37. The micro-reamer according to claim 33, characterized in that the outer shaft is divided into graduated marks.

38. A micro-reamer for creating an intraosseous space, characterized in that it comprises: an expandable cylindrical section in communication with an outer axis, the outer axis and the expandable section both surround an internal axis, the expandable section comprises leaves that flex when the expandable section is activated to create a space for a restoration or injectable composition; wherein the sheets are positioned at an angle for the length of the cylindrical section.

39. The micro-reamer according to claim 38, characterized in that the angle is from about 5 degrees to about 30 degrees.

40. The micro-reamer according to claim 38, characterized in that the angle is from about 10 degrees to about 15 degrees.

41. The micro-reamer according to claim 40, characterized in that the expandable section comprises an elastic metal, a material in composition, a polymer, or another appropriately expandable substance.

42. The micro-reamer according to claim 40, characterized in that the expandable section comprises nitinol.

43. The micro-reamer according to claim 40, characterized in that the outer shaft provides the means for expanding the expandable section.

44. The micro-reamer according to claim 40, characterized in that the outer shaft is divided into graduated marks.