US20070282346A1 - Systems and methods for treating vertebral bodies - Google Patents
Systems and methods for treating vertebral bodies Download PDFInfo
- Publication number
- US20070282346A1 US20070282346A1 US11/890,594 US89059407A US2007282346A1 US 20070282346 A1 US20070282346 A1 US 20070282346A1 US 89059407 A US89059407 A US 89059407A US 2007282346 A1 US2007282346 A1 US 2007282346A1
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- instrument
- bone
- chamber section
- cavity
- plunger
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/30—Joints
- A61F2/46—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
- A61F2002/4685—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor by means of vacuum
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
- A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2310/00—Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
- A61F2310/00005—The prosthesis being constructed from a particular material
- A61F2310/00353—Bone cement, e.g. polymethylmethacrylate or PMMA
Definitions
- the invention generally relates to the treatment of bone conditions in humans and other animals.
- expandable structures generically called “balloons,” into cancellous bone
- U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose apparatus and methods using expandable structures in cancellous bone for the fixation of fractures or other osteoporotic and non-osteoporotic conditions of human and animal bones.
- bone cement or other therapeutic compound can be injected into a targeted bone to repair and/or augment the target bone.
- Several companies offer bone cement injection devices. These devices are similar to a household caulking gun. Typically, the injection device has a pistol-shaped body, which supports a cartridge containing bone cement. The cement is typically in two-parts and must be mixed in a mixer and transferred into the cartridge for injection.
- the injection device has a ram, which is actuated by a manually movable trigger or screwing mechanism for pushing the viscous bone cement out the front of the cartridge through a suitable nozzle and into the interior of a bone targeted for treatment.
- the cement Once injected into the targeted bone, the cement undergoes a curing cycle of perhaps 6 to 8 minutes. While curing, the cement passes from a viscous liquid to a putty-like consistency and finally to a hard rigid block.
- the invention provides, in its various aspects, greater control over the placement of cement and other flowable liquids into bone. Moreover, the invention facilitates the injection of highly viscous filling material into the bone, either into a cavity formed within the bone, or directly into the bone.
- FIG. 2 is a representative coronal view, with portions broken away and in section, of a human vertebral body, which is part of the spinal column shown in FIG. 1 ;
- FIG. 3 is a lateral view, with portions broken away and in section, of several vertebral bodies, which are part of the spinal column shown in FIG. 1 ;
- FIG. 4 is a plan view of a tool which carries at its distal end an expandable structure, which, in use, compresses cancellous bone, the structure being shown in a collapsed condition;
- FIG. 6 is a coronal view of the vertebral body shown in FIG. 2 , with a single tool shown in FIGS. 4 and 5 deployed through a posterolateral access in a collapsed condition;
- FIG. 9A is a coronal view of the vertebral body shown in FIG. 8 , with the cavity filled with a material that strengthens the vertebral body;
- FIG. 9B depicts an alternate method of filling a cavity within a vertebral body
- FIG. 9C depicts the vertebral body of FIG. 9B , wherein the cavity is approximately half-filled with material
- FIG. 9D depicts the vertebral body of FIG. 9B , wherein the cavity is substantially filled with material
- FIGS. 10A to 10 I are coronal views of a vertebral body, showing tools deployed to create a posterolateral access to compress cancellous bone in a vertebral body to form an interior cavity, which is filled with a material to strengthen the vertebral body;
- FIG. 11A is a side view of a tool to introduce material into a cavity formed in cancellous bone, with a nozzle having a stepped profile to reduce overall fluid resistance;
- FIG. 11B is a side view of a tool to introduce material into a cavity formed in cancellous bone, with a nozzle having a tapered profile to reduce overall fluid resistance;
- FIG. 11C is a side view of a tool to introduce material into a cavity formed in cancellous bone, with a nozzle having a reduced interior profile to reduce overall fluid resistance;
- FIG. 12 is an exploded perspective view of a cannula and material introducing device, which embodies features of the invention.
- FIG. 13A is a cross-sectional side view of one embodiment of a filler instrument constructed in accordance with the teachings of the present invention.
- FIG. 13B is a side view of the filler instrument of FIG. 13A , taken along line 13 B- 13 B;
- FIG. 14A is a side view of one embodiment of a first ram assembly constructed in accordance with the teachings of the present invention.
- FIGS. 14B and 14C are side views of the first ram assembly of FIG. 14A ;
- FIG. 15 is a side view of one embodiment of a second ram assembly constructed in accordance with the teachings of the present invention.
- FIGS. 16A through 16C are views of a clip assembly
- FIGS. 17A through 17D are views of an alternate embodiment of a first ram assembly constructed in accordance with the teachings of the present invention.
- FIG. 18 is a side view of an alternate embodiment of a second ram assembly constructed in accordance with the teachings of the present invention.
- FIGS. 19A through 19D are views of another alternate embodiment of a first ram assembly and filler instrument constructed in accordance with the teachings of the present invention.
- the new systems and methods will be described with regard to the treatment of vertebral bodies. It should be appreciated, however, the systems and methods so described are not limited in their application to vertebrae. The systems and methods are applicable to the treatment of diverse bone types, including, but not limited to, such bones as the radius, the humerus, the femur, the tibia or the calcanus.
- the spinal column 10 comprises a number of uniquely shaped bones, called the vertebrae 12 , a sacrum 14 , and a coccyx 16 (also called the tail bone).
- the number of vertebrae 12 that make up the spinal column 10 depends upon the species of animal. In a human (which FIG. 1 shows), there are twenty-four vertebrae 12 , comprising seven cervical vertebrae 18 , twelve thoracic vertebrae 20 , and five lumbar vertebrae 22 .
- the spinal column 10 When viewed from the side, as FIG. 1 shows, the spinal column 10 forms an S-shaped curve.
- the curve serves to support the head, which is heavy. In four-footed animals, the curve of the spine is simpler.
- each vertebra 12 includes a vertebral body 26 , which extends on the anterior (i.e., front or chest) side of the vertebra 12 .
- the vertebral body 26 is in the shape of an oval disk.
- the vertebral body 26 includes an exterior formed from compact cortical bone 28 .
- the cortical bone 28 encloses an interior volume 30 of reticulated cancellous, or spongy, bone 32 (also called medullary bone or trabecular bone).
- a “cushion,” called an intervertebral disk 34 is located between the vertebral bodies 26 .
- the spinal ganglion 39 pass through the foramen 36 .
- the spinal cord 38 passes through the spinal canal 37 .
- the vertebral arch 40 surrounds the spinal canal 37 .
- the pedicle 42 of the vertebral arch 40 adjoins the vertebral body 26 .
- the spinous process 44 extends from the posterior of the vertebral arch 40 , as do the left and right transverse processes 46 .
- Access to a vertebral body can be accomplished from many different directions, depending upon the targeted location within the vertebral body, the intervening anatomy, and the desired complexity of the procedure. For example, access can also be obtained through a pedicle 42 (transpedicular), outside of a pedicle (extrapedicular), along either side of the vertebral body (posterolateral), laterally or anteriorly.
- pedicle 42 transpedicular
- extrapedicular outside of a pedicle
- such approaches can be used with a closed, minimally invasive procedure or with an open procedure.
- FIG. 4 shows a tool 48 for preventing or treating compression fracture or collapse of a vertebral body using an expandable body.
- the tool 48 includes a catheter tube 50 having a proximal and a distal end, respectively 52 and 54 .
- the distal end 54 carries a structure 56 having an expandable exterior wall 58 .
- FIG. 4 shows the structure 56 with the wall 58 in a collapsed geometry.
- FIG. 5 shows the structure 56 in an expanded geometry.
- FIG. 6 shows the collapsed geometry permits insertion of the structure 56 into the interior volume 30 of a targeted vertebral body 26 , as FIG. 6 shows.
- the structure 56 can be introduced into the interior volume 30 in various ways.
- FIG. 6 shows the insertion of the structure 56 through a single lateral access, which extends through a lateral side of the vertebral body 12 .
- Lateral access is indicated, for example, if a compression fracture has collapsed the vertebral body 26 below the plane of the pedicle 42 , or for other reasons based upon the preference of the physician. Lateral access can be performed either with a closed, minimally invasive procedure or with an open procedure. Of course, depending upon the intervening anatomy, well known in the art, lateral access may not be the optimal access path for treatment of vertebrae at all levels of the spine.
- the catheter tube 50 includes an interior lumen 80 (see FIG. 4 ).
- the lumen 80 is coupled at the proximal end of the catheter tube 50 to a pressurized source of fluid, e.g., saline.
- a syringe containing the fluid can comprise the pressure source.
- the lumen 80 conveys the fluid into the structure 56 under pressure. As a result, the wall 58 expands, as FIGS. 5 and 7 show.
- the fluid is preferably rendered radio-opaque, to facilitate visualization as it enters the structure 56 .
- RenograffinTM can be used for this purpose.
- expansion of the structure 56 can be monitored fluoroscopically or under CT visualization.
- the structure 56 may be filled with sterile water, saline solution, or sugar solution, free of a radiopaque material.
- other types of visualization could be used, with the tool 48 carrying compatible reference markers.
- the structure could incorporate a radiopaque material within the material of the structure, or the structure could be painted or dusted with a radiopaque material.
- Expansion of the wall 58 enlarges the structure 56 , desirably compacting cancellous bone 32 within the interior volume 30 (see FIG. 7 ) and/or causing desired displacement of cortical bone.
- the compaction of cancellous bone 32 forms a cavity 60 in the interior volume 30 of the vertebral body 26 (see FIG. 8 ).
- a filling material 62 can be safely and easily introduced into the cavity 60 which the compacted cancellous bone 32 forms.
- expansion of the structure 56 desirably forms a region of compacted cancellous bone which substantially surrounds the cavity 60 . This region desirably comprises a physical barrier which limits leakage of the filling material 62 outside the vertebral body 26 .
- the expansion of the structure 56 also desirably presses cancellous bone 32 into small fractures which may be present in cortical bone, thereby reducing the possibility of the filling material 62 exiting through the cortical wall.
- the expansion of the structure 56 desirably flattens veins in the vertebral body that pass through the cortical wall (e.g., the basivertebral vein), resulting in less opportunity for filling material 62 to extravazate outside the vertebral body through the veinous structure in the cortical wall.
- expansion of the structure 56 will compress less dense and/or weaker regions of the cancellous bone, which desirably increases the average density and/or overall strength of the remaining cancellous bone.
- the compaction of cancellous bone by the structure 56 can also exert interior force upon cortical bone.
- the structure 56 can directly contact the cortical bone, such that expansion and/or manipulation of the structure will cause displacement of the cortical bone. Expansion of the structure 56 within the vertebral body 26 thereby makes it possible to elevate or push broken and compressed bone back to or near its original prefracture position.
- the structure 56 is preferably left inflated within the vertebral body 26 for an appropriate waiting period, for example, three to five minutes, to allow some coagulation inside the vertebral body 26 to occur. After the appropriate waiting period, the physician collapses and removes the structure 56 . As FIG. 8 shows, upon removal of the structure 56 , the formed cavity 60 desirably remains in the interior volume 30 .
- the physician next introduces a filling material 62 into the formed cavity 60 .
- the filling material 62 can comprise a material that resists torsional, tensile, shear and/or compressive forces within the cavity 60 , thereby providing renewed interior structural support for the cortical bone 28 .
- the material 62 can comprise a flowable material, such as bone cement, allograft tissue, autograft tissue, or hydroxyapatite, synthetic bone substitute, which is introduced into the cavity 60 and which, in time, sets to a generally hardened condition.
- the material 62 can also comprise a compression-resistant material, such as rubber, polyurethane, cyanoacrylate, or silicone rubber, which is inserted into the cavity 60 .
- the material 62 can also comprise a semi-solid slurry material (e.g., a bone slurry in a saline base), which is either contained within a porous fabric structure located in the cavity 60 or injected directly into the cavity 60 , to resist compressive forces within the cavity 60 .
- a semi-solid slurry material e.g., a bone slurry in a saline base
- the material 62 could comprise stents, reinforcing bar (Re-Bar) or other types of internal support structures, which desirably resist compressive, tensile, torsional and/or shear forces acting on the bone and/or filler material.
- the filling material 62 may also comprise a medication, or a combination of medication and a compression-resistant material, as described above.
- the filling material 62 can comprise a bone filling material which does not withstand compressive, tensile, torsional and/or shear forces within the cavity.
- the filling material 62 need not be able to immediately bear loads.
- the filling material 62 could provide a scaffold for bone growth, or could comprise a material which facilitates or accelerates bone growth, allowing the bone to heal over a period of time.
- the filling material could comprise a resorbable or partially-resorbable source of organic or inorganic material for treatment of various bone or non-bone-related disorders including, but not limited to, osteoporosis, cancer, degenerative disk disease, heart disease, acquired immune deficiency syndrome (AIDS) or diabetes.
- the cavity and/or filler material could comprise a source of material for treatment of disorders located outside the treated bone.
- the expandable structure 56 can be left in the cavity 60 .
- flowable filling material 62 is conveyed into the structure 56 , which serves to contain the material 62 .
- the structure 56 filled with the material 62 , serves to provide the renewed interior structural support function for the cortical bone 28 .
- the structure 56 can be made from an inert, durable, non-degradable plastic material, e.g., polyethylene and other polymers.
- the structure 56 can be made from an inert, bio-absorbable material, which degrades over time for absorption or removal by the body.
- the filling material 62 itself can serve as the expansion medium for the structure 56 , to compact cancellous bone and form the cavity 60 , to thereby perform both compaction and interior support functions.
- the structure 56 can be first expanded with another medium to compact cancellous bone and form the cavity 60 , and the filling material 62 can be subsequently introduced after the expansion medium is removed from structure 56 to provide the interior support function.
- the filling material could comprise a two-part material including, but not limited to, settable polymers or calcium alginate. If desired, one part of the filling material could be utilized as the expansion medium, and the second part added after the desired cavity size is achieved.
- the structure 56 can be made from a permeable, semi-permeable, or porous material, which allows the transfer of medication contained in the filling material 62 into contact with cancellous bone through the wall of the structure 56 .
- the material can comprise a membrane that allows osmotic and/or particulate transfer through the material, or the material can comprise a material that allows the medication to absorb into and/or diffuse through the material.
- medication can be transported through a porous wall material by creating a pressure differential across the wall of the structure 56 .
- fluids, cells and/or other materials from the patient's body can pass and/or be drawn through the material into the structure for various purposes including, but not limited to, fluid/cellular analysis, bony ingrowth, bone marrow harvesting, and/or gene therapy (including gene replacement therapy).
- a patient lies on an operating table.
- the patient can lie face down on the table, or on either side, or at an oblique angle, depending upon the physician's preference.
- the physician For each access (see FIG. 10A ), the physician introduces a spinal needle assembly 70 into soft tissue ST in the patient's back. Under radiologic or CT monitoring, the physician advances the spinal needle assembly 70 through soft tissue down to and into the targeted vertebral body 26 .
- the physician can also employ stereotactic instrumentation to guide advancement of the spinal needle assembly 70 and subsequent tools during the procedure.
- the reference probe for stereotactic guidance can be inserted through soft tissue and implanted on the surface of the targeted vertebral body.
- the entire procedure can also be monitored using tools and tags made of non-ferrous materials, e.g., plastic or fiber composites, such as those disclosed in U.S. Pat. Nos. 5,782,764 and 5,744,958, which are each incorporated herein by reference, which would be suitable for use in a computer enhanced, whole-room MRI environment.
- the physician will typically administer a local anesthetic, for example, lidocaine, through the assembly 70 .
- a local anesthetic for example, lidocaine
- the physician may prefer other forms of anesthesia.
- the physician directs the spinal needle assembly 70 to penetrate the cortical bone 28 and the cancellous bone 32 through the side of the vertebral body 26 .
- the depth of penetration is about 60% to 95% of the vertebral body 26 .
- the physician holds the stylus 72 and withdraws the stylet 74 of the spinal needle assembly 70 . As FIG. 10B shows, the physician then slides a guide pin instrument 76 through the stylus 72 and into the cancellous bone 32 . The physician now removes the stylus 72 , leaving the guide pin instrument 76 deployed within the cancellous bone 32 .
- the physician next slides an obturator instrument 78 over the guide pin instrument 76 , distal end first, as FIG. 10C shows.
- the physician can couple the obturator instrument 78 to a handle 80 , which facilitates manipulation of the instrument 78 .
- the physician makes a small incision in the patient's back.
- the physician twists the handle 80 while applying longitudinal force to the handle 80 .
- the obturator instrument 78 rotates and penetrates soft tissue through the incision.
- the physician may also gently tap the handle 80 , or otherwise apply appropriate additional longitudinal force to the handle 80 , to advance the obturator instrument 78 through the soft tissue along the guide pin instrument 76 down to the cortical bone entry site.
- the physician can also tap the handle 80 with an appropriate striking tool to advance the obturator instrument 78 into a side of the vertebral body 26 to secure its position.
- the obturator instrument 78 shown in FIG. 10C has an outside diameter that is generally well suited for establishing a lateral access. However, if access is desired through the more narrow region of the vertebral body 26 , e.g., a pedicle 42 (called transpedicular access), the outside diameter of the obturator instrument 78 can be reduced. The reduced diameter of the obturator instrument 78 mediates against damage or breakage of the pedicle 42 . It should be understood that the disclosed methods and devices are well suited for use in conjunction with other approach paths, such as pedicular, extra-pedicular, posterolateral and anterior approaches, with varying results.
- the physician then proceeds to slide the handle 80 off the obturator instrument 78 and to slide a cannula instrument 84 over the guide pin instrument 76 and, further, over the obturator instrument 78 .
- the physician can also couple the handle 80 to the cannula instrument 84 , to apply appropriate twisting and longitudinal forces to rotate and advance the cannula instrument 84 through soft tissue ST over the obturator instrument 78 .
- the physician can appropriately tap the handle 80 with a striking tool to advance the end surface into the side of the vertebral body 26 to secure its position.
- the physician now withdraws the obturator instrument 78 , sliding it off the guide pin instrument 76 , leaving the guide pin instrument 76 and the cannula instrument 84 in place.
- the physician can remove an inner centering sleeve (not shown).
- the physician slides a drill bit instrument 88 over the guide pin instrument 76 , distal end first, through the cannula instrument 84 , until contact between the machined or cutting edge 90 of the drill bit instrument 88 and cortical bone 28 occurs.
- the physician then couples the drill bit instrument 88 to the handle 80 .
- the physician applies appropriate twisting and longitudinal forces to the handle 80 , to rotate and advance the machined edge 90 of the drill bit instrument 88 to open a lateral passage PLA through the cortical bone 28 and into the cancellous bone 32 .
- the drilled passage PLA preferably extends no more than 95% across the vertebral body 26 .
- the physician removes the drill bit instrument 88 and the guide pin instrument 76 , leaving only the cannula instrument 84 in place, as FIG. 10E shows.
- the passage PLA made by the drill bit instrument 88 remains. Subcutaneous lateral access to the cancellous bone 32 has been accomplished.
- the physician can fill a syringe 112 with the desired volume of filling material 62 , a batch of which has been previously prepared.
- the cavity volume created is known. The physician thereby knows the desired volume of material 62 to place in the syringe 112 for each cavity formed in the vertebral body 26 .
- the physician attaches a nozzle 114 to the filled syringe 112 .
- the physician then proceeds to deflate and remove the expandable structure through the associated cannula instrument 84 and to fill the associated cavity with the material 62 .
- the physician inserts the nozzle 114 through the associated cannula instrument a selected distance into the cavity, guided, e.g., by exterior markings 116 or by real-time fluoroscope or x-ray or MRI visualization.
- the physician operates the syringe 112 to cause the material 62 to flow through and out of the nozzle 114 and into the cavity portion.
- the nozzle 114 may posses a uniform interior diameter, sized to present a distal end dimension that facilitates insertion into the vertebral body.
- the nozzle 114 can possess an interior diameter (e.g., see FIG.
- a tool 160 can possess an interior lumen 162 that gradually tapers from a larger interior diameter to a smaller interior diameter.
- FIG. 11B a tool 160 can possess an interior lumen 162 that gradually tapers from a larger interior diameter to a smaller interior diameter.
- a tool 164 can possess an interior lumen 166 that steps from a larger to a smaller interior diameter.
- An associated cannula instrument 168 may also include a reduced diameter passage, which is downsized to accommodate the reduced diameter tool and to present less flow resistance to filling material conveyed through the cannula instrument.
- the reduced diameter tool may also be used in association with a vertebroplasty procedure, which injects cement under pressure into a vertebral body, without prior formation of a cavity.
- the filling material 62 may contain a predetermined amount of a radiopaque material, e.g., barium or tungsten, sufficient to enable visualization of the flow of material 62 into the cavity portion.
- a radiopaque material e.g., barium or tungsten
- the amount of radiopaque material is desirably at least 10%, more desirably at least 20%, and most desirably at least 30%. The physician can thereby visualize the cavity filling process.
- the physician withdraws the nozzle 114 from the cavity portion and into the cannula instrument 84 .
- the cannula instrument 84 channels the material flow toward the cavity portion. The material flows in a stream into the cavity portion.
- the physician operates the syringe 112 to expel the material 62 through the nozzle 114 , first into the cavity portion and then into the cannula instrument 84 .
- material 62 should extend from the cavity and occupy about 40% to 50% of the cannula instrument 84 .
- the physician can utilize the syringe 112 to fill the lumen of the nozzle 114 and/or cannula instrument 84 with material 62 , and then utilize a tamping instrument 124 to expel the material from the lumen into the vertebral body.
- the physician withdraws the nozzle 114 from the cannula instrument 84 .
- the physician may first rotate the syringe 112 and nozzle 114 , to break loose the material 62 in the nozzle 114 from the ejected bolus of material 62 occupying the cannula instrument 84 .
- the use of the syringe 112 , nozzle 114 , and the tamping instrument 124 allows the physician to exert precise control when filling the cavity portion with material 62 .
- the physician can immediately adjust the volume and rate of delivery according to the particular local physiological conditions encountered.
- the application of low pressure, which is uniformly applied by the syringe 112 and the tamping instrument 124 allows the physician to respond to fill volume and flow resistance conditions in a virtually instantaneous fashion. The chance of overfilling and leakage of material 62 outside the cavity portion is significantly reduced.
- FIG. 12 depicts a material injection instrument 500 comprising a reduced diameter nozzle 180 and a stylet 182 .
- the stylet 182 is desirably sized to pass through the reduced diameter nozzle 180 .
- the nozzle 180 is desirably sized to pass through the cannula instrument 184 .
- the nozzle 180 can be formed from a substantially rigid metal material, e.g., stainless steel or a high strength plastic.
- the stylet 182 includes a handle 192 , which rests on the proximal connector 186 of the nozzle when the stylet 182 is fully inserted into the nozzle 180 .
- the handle When the handle is rested, the distal ends of the stylet 182 and nozzle 180 align.
- the presence of the stylet 182 inside the nozzle 180 desirably closes the interior bore.
- the nozzle 180 can be coupled to the syringe 104 and inserted through the cannula instrument 184 into a material-receiving cavity (not shown) formed within a bone.
- Material 62 in the syringe 104 is injected into the nozzle 180 where it desirably passes into the bone.
- the syringe 104 may be removed from the nozzle 180 .
- the stylet 182 can then be inserted into the nozzle 180 , and advanced through the nozzle, desirably pressurizing the material 62 and pushing it out of the nozzle 180 .
- the stylet 182 has a diameter of approximately 0.118 in.
- the cross-sectional area of this stylet 182 is approximately 0.010936 in 2
- the nozzle 180 desirably contains approximately 1.5 cc of filler material.
- the stylet 182 has a diameter of approximately 0.136 in.
- the nozzle 180 and stylet 182 can be used in a similar manner as a combination ram 183 to push the filler material 62 through the cannula instrument 184 into the bone.
- the insertion of the ram 183 into the cannula 184 will desirably displace the material 62 , forcing the material 62 from the distal end of the cannula 184 into the bone.
- the diameter of the ram 183 is approximately 0.143 in.
- the ram 183 acts as a positive displacement “piston” or “pump,” which permits the physician to accurately gauge the precise amount of filler material 62 that is injected into the bone.
- the disclosed systems and methods obviate and/or reduce the need for complex, high pressure injection systems for delivery of filler materials. Because the disclosed ram 183 travels subcutaneously through the cannula 184 , and displaces filler material 62 out the distal end of the cannula 184 , the amount of filler material being pushed by the ram 183 (and the total amount of filler material 62 within the cannula 184 ) progressively decreases as filler material is injected into the bone. This desirably results in an overall decrease in resistance to movement of the ram during injection. Moreover, because the amount of material being pushed by the ram 183 decreases, an increase in the flow resistance of the curing filler material does not necessarily require an increase in injection pressure.
- the filler material need only be “pumped” a short length before it exits the cannula and enters the bone, further reducing the need for extremely high pressures. If injection of additional filler material is required, the ram can be withdrawn from the cannula, additional filler material can be introduced into the cannula, and the process repeated.
- the present arrangement facilitates injection of even extremely viscous materials under well controlled conditions.
- a wide range of pressures can be generated in the filler material 62 .
- the disclosed devices could similarly be used to inject filler material through a spinal needle assembly directly into bone, in a vertebroplasty-like procedure, or can be used to fill a cavity created within the bone.
- the physician may choose to continue injecting additional material 62 into the vertebral body.
- this additional material may merely increase the volume of the cavity (by further compacting cancellous bone), or may travel into the compressed and/or uncompressed cancellous bone surrounding the cavity, which may serve to further compress cancellous bone and/or further enhance the compressive strength of the vertebral body.
- the physician withdraws the tamping instrument 124 from the cannula instrument 84 .
- the physician preferably first twists the tamping instrument 124 to cleanly break contact with the material 62 .
- the cannula instrument 84 can be withdrawn and the incision site sutured closed.
- FIGS. 9B through 9D depict an alternate method of filling a cavity 60 formed within a vertebral body.
- a cannula instrument 84 has been advanced through a pedicle 42 of the vertebral body by, providing access to a cavity 60 formed therein.
- a nozzle 180 is advanced into the vertebral body, with the distal tip of the nozzle 180 desirably positioned near the anterior side of the cavity 60 .
- Filler material 62 is slowly injected through the nozzle 180 into the cavity 60 . As injection of filler material 62 continues, the nozzle 180 is withdrawn towards the center of the cavity 60 . See FIG. 9 c .
- the filler material can be allowed to harden and/or cure before injection into the vertebral body.
- the filler material comprises bone cement, which is allowed to cure to a glue or putty-like state before being injected into the cavity.
- the cement would desirably have a consistency similar to toothpaste as the cement begins to extrude from the nozzle.
- the paste or pellet graft tissue material is loaded into the cannula instrument 84 30 .
- the tamping instrument 124 is then advanced into the cannula instrument 84 in the manner previously described, to displace the paste or pellet graft tissue material out of the cannula instrument 84 and into the cavity portion.
- the selected material 62 can also comprise a granular bone material harvested from coral, e.g., ProOsteonTM calcium carbonate granules, available from Interpore.
- the granules are loaded into the cannula instrument 84 using a funnel and advanced into the cavity using the tamping instrument 124 .
- the selected material 62 can also comprise demineralized bone matrix suspended in glycerol (e.g., GraftonTM allograft material available from Osteotech), or SRS® calcium phosphate cement available from Norian.
- demineralized bone matrix suspended in glycerol e.g., GraftonTM allograft material available from Osteotech
- SRS® calcium phosphate cement available from Norian.
- the selected material 62 can also be in sheet form, e.g. Collagraft® material made from calcium carbonate powder and collagen from bovine bone.
- the sheet can be rolled into a tube and loaded by hand into the cannula instrument 84 .
- the tamping instrument 124 is then advanced through the cannula instrument 84 , to push and compact the material in the cavity portion.
- the first section 605 has a first interior cross-sectional area 615
- the second section 610 has a second interior cross-sectional area 620
- the first interior cross-sectional area 615 will be greater than the second interior cross-sectional area 620
- the first section 605 comprises a cylindrical, hollow, tubular member having an interior diameter of 0.358 inches and a length of 2.58 inches
- the second section comprises a cylindrical, hollow, tubular member having an interior diameter of 0.175 inches and a length of 8.84 inches.
- a dispensing opening 640 is formed at the distal tip 645 of the second section 610 .
- a first ram opening 650 is formed at the proximal end of the first section 605 .
- a flange 655 can be formed on the outer portion of the first section 605 .
- the transition from the first section 605 to the second section 610 can neck down or taper, as shown in FIG. 13A .
- a ram flange 725 can be formed on the distal portion of the first plunger 705 .
- the ram flange 725 will abut and/or contact the flange 655 when the distal end of the first plunger 705 reaches a desired position near or abutting the distal end of the first section 605 .
- the first ram assembly 700 further comprises a second ram opening 720 extending longitudinally through the first plunger 705 .
- the size and shape of the cross-sectional area of the second ram opening 720 will be less than or approximate the size and shape of the second interior cross-sectional area 620 .
- the first ram assembly 700 is 2.62 inches long, the first plunger 705 having an outer diameter of 0.357 inches, and the inner diameter of the second ram opening 720 is 0.115 inches.
- FIG. 15 depicts a second ram assembly 750 suitable for use with the first ram assembly 700 and the filler instrument 600 .
- the second ram assembly 750 comprises a second plunger 755 , and a knob 760 secured to the proximal end of the second plunger 755 .
- the second plunger 755 is desirably sized to pass through the second ram opening 720 and the second section 610 .
- the second ram assembly further comprises a notch 765 .
- a retaining clip 800 (see FIGS. 16A through 16C ) desirably releasably secures the second ram assembly 750 within the second ram opening 755 .
- the second ram assembly 750 is 11.8 inches long, the second plunger 755 has an outer diameter of 0.113 inches, and the notch 765 is located approximately 2.62 inches from the distal tip of the second plunger 755 .
- the various components of the filler instrument 600 can comprise a substantially rigid metal, plastic or ceramic material, e.g., stainless steel or a high strength plastic.
- the filler instrument 600 and second ram assembly comprise 303 stainless steel, and the first ram assembly comprises Delrin® plastic (available commercially from DuPont Corporation).
- the filler instrument 600 When injection of filler material is desired, the filler instrument 600 is filled with filler material (not shown) such as bone cement or PMMA.
- filler material such as bone cement or PMMA.
- the second ram assembly 750 is secured within the first ram assembly with the retaining clip 800 .
- the distal end 715 of the first plunger 705 is then inserted into the first ram opening 650 .
- filler material in the first section 605 is displaced by the plunger 705 , which in turn forces material in the second section 610 out through the dispensing opening 640 .
- Passage of a significant amount of filler material through the second ram opening 755 is prevented by the presence of the second plunger 755 , which is desirably held in position by the retaining clip 800 .
- the distal end 715 approaches the distal end of the first section 605 desirably substantially all of the filler material will be displaced from the first section 605 into the second section 610 and/or out the dispensing opening 640 .
- the retaining clip 800 is then released, and the second plunger 755 advanced through the distal end of the first section 605 and into the second section 610 .
- the shape and size of the cross-sectional area of the second plunger 755 will approximate the shape and size of the cross-sectional area 620 of the second section 610 , such that the second plunger 755 displaces substantially all of the filler material in the second section 610 as the second plunger 755 advances.
- substantially all of the filler material within the first and second sections 605 and 610 will be dispensed from the filler instrument 600 .
- the present invention facilitates dispensing of a substantial amount of filler material from a single filler instrument. Because the viscosity of PMMA and various other types of filler materials typically increases with time during the dispensing process, it becomes progressively harder to dispense filler material over time. By utilizing a plunger of larger cross-sectional area to initiate the filling operation, when the filler material is less viscous, the present invention allows dispensing of a significant amount of filler material.
- the reduced cross-sectional area of the second plunger allows continued dispensing of the more viscous filler material, even when it is in a highly viscous state.
- the second section is of reduced cross-sectional area, its reduced profile will desirably allow the distal tip of the filler instrument to be introduced through the cannula and/or soft tissues and directly into the targeted vertebral body, while still providing a sufficient reservoir of filler material to accomplish the goals of augmenting and/or repairing the targeted bone.
- the tool need not be refilled and/or “switched out” during the dispensing operation, but can rather remain in place and dispense the entire required amount of bone filler for the procedure, the potential for trapping air within the vertebral body and/or bolus of cement is significantly reduced.
- the present invention also greatly facilitates the ability of the physician to immediately shift from a higher volume, lower pressure cement flow to a lower volume, higher pressure cement flow.
- the physician may determine that a more controlled, higher pressure and/or lower volume flow of cement is needed.
- the cement may cure or harden to a point where further movement of the first plunger is extremely difficult and/or impossible to effect.
- One embodiment of the present invention permits the physician to advance the second plunger into the second section, even when the distal end of the first plunger is not near and/or abutting the distal end of the first section.
- the second plunger passes through the cement in the first section, and enters the second section, cement will be displaced from the second section. Due to the decreased cross-sectional area of the second plunger and second section (as compared to the first plunger and first section), the second plunger is easier to push through the cement in the first section and cement can more easily be dispensed from the second section at higher pressures and/or lower volumes.
- the disclosed filler instrument may be used to introduce filler material through a cannula into a cavity created within a bone, or may be used with vertebroplasty-type techniques to introduce filler material directly into the vertebral body without prior formation of a cavity. Where prior cavity-formation is not required and/or desired, and vertebroplasty-like techniques will be used, the filler instrument can incorporate a needle-point at the distal end of the instrument, or the diameter of the second section can be significantly reduced to allow passage of the instrument through the lumen of a spinal needle assembly.
- one or more of the sections of the filler instrument could comprise a commercially available spinal needle assembly (such as a Bone Marrow Biopsy Needle No. 508627, available from Becton Dickinson & Co., Franklin Lakes, N.J., 07417). If desired, one or more plunger assemblies of varying sizes and lengths could be provided to accommodate differing spinal needle assemblies.
- the filler instrument can be pre-loaded with filler material, introduced through soft tissues and into the vertebral body, used to inject filler material, and removed, quickly and easily without need for tool exchanges during the operation.
- filler material introduced through soft tissues and into the vertebral body, used to inject filler material, and removed, quickly and easily without need for tool exchanges during the operation.
- bone cement can be injected under pressure through a needle directly into the cancellous bone of the vertebral body (without cavity formation). The bone cement penetrates cancellous bone.
- the filler instrument can possess an increasing interior diameter, as shown in FIGS. 11A, 11B , or 11 C.
- the reduced flow resistance would make possible the use of more viscous cement, to thereby further reduce the possibility that the cement would exude from the vertebral body.
- FIGS. 17A through 17D and FIG. 18 depict an alternate embodiment of a filler instrument constructed in accordance with the teachings of the present invention. Because many of the features of this embodiment are similar to those previously described, like reference numerals will be used to describe similar components.
- the first ram assembly 700 A further comprises an increased cross-sectional tip opening 850 within the distal end 715 A of the assembly 700 A. This tip opening 850 corresponds to a increased cross-sectional plunger tip 855 on the second plunger 755 .
- the plunger tip 855 seats within the tip opening 850 , desirably preventing the second plunger 750 A from moving axially in response to the increased pressure of the filler material.
- a clip (not shown) can be utilized to secure the second plunger to the first plunger. Once the first plunger 705 A has been advanced to its desired position, the clip (not shown) can be removed from the notch 765 A, and the second plunger 750 A advanced as previously described.
- FIGS. 19A through 19D depict another alternate embodiment of a filler instrument 600 B constructed in accordance with the teachings of the present invention. Because many of the features of this embodiment are similar to those previously described, like reference numerals will be used to describe similar components.
- the first ram assembly 700 B comprises a check valve 900 located at the distal tip 715 of the assembly 700 B.
- the check valve 900 will desirably prevent filler material from travelling through the second ram opening 720 B as the first plunger 705 B is advanced.
- the check valve 900 permits passage of the second plunger into the first and second sections as previously described.
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Abstract
Description
- This application is a divisional of co-pending patent application Ser. No. 10/640,790 filed 14 Aug. 2003, which is a divisional of application Ser. No. 09/905,170 filed 13 Jul. 2001, now U.S. Pat. No. 6,641,587, which is a continuation-in-part of application Ser. No. 09/134,323 filed 14 Aug. 1998, and entitled Systems and Methods for Placing Materials into Bone, now U.S. Pat. No. 6,241,734, and which claims the benefit of provisional application Ser. No. 60/218,237 filed 14 Jul. 2000.
- The invention generally relates to the treatment of bone conditions in humans and other animals.
- The deployment of expandable structures, generically called “balloons,” into cancellous bone is known. For example, U.S. Pat. Nos. 4,969,888 and 5,108,404 disclose apparatus and methods using expandable structures in cancellous bone for the fixation of fractures or other osteoporotic and non-osteoporotic conditions of human and animal bones.
- As part of a fracture fixation procedure, bone cement or other therapeutic compound can be injected into a targeted bone to repair and/or augment the target bone. Several companies offer bone cement injection devices. These devices are similar to a household caulking gun. Typically, the injection device has a pistol-shaped body, which supports a cartridge containing bone cement. The cement is typically in two-parts and must be mixed in a mixer and transferred into the cartridge for injection.
- Just after mixing, and prior to curing, the cement is in a flowing, viscous liquid state, similar to a syrup or watery pancake batter in consistency. The injection device has a ram, which is actuated by a manually movable trigger or screwing mechanism for pushing the viscous bone cement out the front of the cartridge through a suitable nozzle and into the interior of a bone targeted for treatment.
- Once injected into the targeted bone, the cement undergoes a curing cycle of perhaps 6 to 8 minutes. While curing, the cement passes from a viscous liquid to a putty-like consistency and finally to a hard rigid block.
- The invention provides, in its various aspects, greater control over the placement of cement and other flowable liquids into bone. Moreover, the invention facilitates the injection of highly viscous filling material into the bone, either into a cavity formed within the bone, or directly into the bone.
- Features and advantages of the inventions are set forth in the following Description and Drawings, as well as in the appended Claims.
-
FIG. 1 is a lateral view of a human spinal column; -
FIG. 2 is a representative coronal view, with portions broken away and in section, of a human vertebral body, which is part of the spinal column shown inFIG. 1 ; -
FIG. 3 is a lateral view, with portions broken away and in section, of several vertebral bodies, which are part of the spinal column shown inFIG. 1 ; -
FIG. 4 is a plan view of a tool which carries at its distal end an expandable structure, which, in use, compresses cancellous bone, the structure being shown in a collapsed condition; -
FIG. 5 is enlarged side view of the expandable structure carried by the tool shown inFIG. 4 ; -
FIG. 6 is a coronal view of the vertebral body shown inFIG. 2 , with a single tool shown inFIGS. 4 and 5 deployed through a posterolateral access in a collapsed condition; -
FIG. 7 is a coronal view of the vertebral body and tool shown inFIG. 6 , with the tool in an expanded condition to compress cancellous bone and form a cavity; -
FIG. 8 is a coronal view of the vertebral body shown inFIGS. 6 and 7 , with the tool removed after formation of the cavity; -
FIG. 9A is a coronal view of the vertebral body shown inFIG. 8 , with the cavity filled with a material that strengthens the vertebral body; -
FIG. 9B depicts an alternate method of filling a cavity within a vertebral body; -
FIG. 9C depicts the vertebral body ofFIG. 9B , wherein the cavity is approximately half-filled with material; -
FIG. 9D depicts the vertebral body ofFIG. 9B , wherein the cavity is substantially filled with material; -
FIGS. 10A to 10I are coronal views of a vertebral body, showing tools deployed to create a posterolateral access to compress cancellous bone in a vertebral body to form an interior cavity, which is filled with a material to strengthen the vertebral body; -
FIG. 11A is a side view of a tool to introduce material into a cavity formed in cancellous bone, with a nozzle having a stepped profile to reduce overall fluid resistance; -
FIG. 11B is a side view of a tool to introduce material into a cavity formed in cancellous bone, with a nozzle having a tapered profile to reduce overall fluid resistance; -
FIG. 11C is a side view of a tool to introduce material into a cavity formed in cancellous bone, with a nozzle having a reduced interior profile to reduce overall fluid resistance; -
FIG. 12 is an exploded perspective view of a cannula and material introducing device, which embodies features of the invention; -
FIG. 13A is a cross-sectional side view of one embodiment of a filler instrument constructed in accordance with the teachings of the present invention; -
FIG. 13B is a side view of the filler instrument ofFIG. 13A , taken along line 13B-13B; -
FIG. 14A is a side view of one embodiment of a first ram assembly constructed in accordance with the teachings of the present invention; -
FIGS. 14B and 14C are side views of the first ram assembly ofFIG. 14A ; -
FIG. 14D is a cross-sectional view of the first ram assembly ofFIG. 14C , taken along line 14D-14D; -
FIG. 15 is a side view of one embodiment of a second ram assembly constructed in accordance with the teachings of the present invention; -
FIGS. 16A through 16C are views of a clip assembly; -
FIGS. 17A through 17D are views of an alternate embodiment of a first ram assembly constructed in accordance with the teachings of the present invention; -
FIG. 18 is a side view of an alternate embodiment of a second ram assembly constructed in accordance with the teachings of the present invention; -
FIGS. 19A through 19D are views of another alternate embodiment of a first ram assembly and filler instrument constructed in accordance with the teachings of the present invention. - The invention may be embodied in several forms without departing from its spirit or essential characteristics. The scope of the invention is defined in the appended claims, rather than in the specific description preceding them. All embodiments that fall within the meaning and range of equivalency of the claims are therefore intended to be embraced by the claims.
- This Specification describes new systems and methods to treat bones. The use of expandable bodies to treat bones is generally disclosed in U.S. Pat. Nos. 4,969,888 and 5,108,404, which are incorporated herein by reference. Improvements in this regard are disclosed in U.S. patent application Ser. No. 08/188,224, filed Jan. 26, 1994; U.S. patent application Ser. No. 08/485,394, filed Jun. 7, 1995; and U.S. patent application Ser. No. 08/659,678, filed Jun. 5, 1996, which are each incorporated herein by reference. It should also be appreciated that the new systems and methods can be utilized to treat bones without use of expandable bodies, if desired.
- The new systems and methods will be described with regard to the treatment of vertebral bodies. It should be appreciated, however, the systems and methods so described are not limited in their application to vertebrae. The systems and methods are applicable to the treatment of diverse bone types, including, but not limited to, such bones as the radius, the humerus, the femur, the tibia or the calcanus.
- I. Vertebral Bodies
- As
FIG. 1 shows, thespinal column 10 comprises a number of uniquely shaped bones, called thevertebrae 12, asacrum 14, and a coccyx 16 (also called the tail bone). The number ofvertebrae 12 that make up thespinal column 10 depends upon the species of animal. In a human (whichFIG. 1 shows), there are twenty-fourvertebrae 12, comprising sevencervical vertebrae 18, twelvethoracic vertebrae 20, and fivelumbar vertebrae 22. - When viewed from the side, as
FIG. 1 shows, thespinal column 10 forms an S-shaped curve. The curve serves to support the head, which is heavy. In four-footed animals, the curve of the spine is simpler. - As FIGS. 1 to 3 show, each
vertebra 12 includes avertebral body 26, which extends on the anterior (i.e., front or chest) side of thevertebra 12. As FIGS. 1 to 3 show, thevertebral body 26 is in the shape of an oval disk. AsFIGS. 2 and 3 show, thevertebral body 26 includes an exterior formed from compactcortical bone 28. Thecortical bone 28 encloses aninterior volume 30 of reticulated cancellous, or spongy, bone 32 (also called medullary bone or trabecular bone). A “cushion,” called anintervertebral disk 34, is located between thevertebral bodies 26. - An opening, called the
vertebral foramen 36, is located on the posterior (i.e., back) side of eachvertebra 12. Thespinal ganglion 39 pass through theforamen 36. Thespinal cord 38 passes through thespinal canal 37. - The
vertebral arch 40 surrounds thespinal canal 37. Thepedicle 42 of thevertebral arch 40 adjoins thevertebral body 26. Thespinous process 44 extends from the posterior of thevertebral arch 40, as do the left and right transverse processes 46. - II. Treatment of Vertebral Bodies
- A. Lateral Access
- Access to a vertebral body can be accomplished from many different directions, depending upon the targeted location within the vertebral body, the intervening anatomy, and the desired complexity of the procedure. For example, access can also be obtained through a pedicle 42 (transpedicular), outside of a pedicle (extrapedicular), along either side of the vertebral body (posterolateral), laterally or anteriorly. In addition, such approaches can be used with a closed, minimally invasive procedure or with an open procedure.
-
FIG. 4 shows atool 48 for preventing or treating compression fracture or collapse of a vertebral body using an expandable body. - The
tool 48 includes acatheter tube 50 having a proximal and a distal end, respectively 52 and 54. Thedistal end 54 carries astructure 56 having anexpandable exterior wall 58.FIG. 4 shows thestructure 56 with thewall 58 in a collapsed geometry.FIG. 5 shows thestructure 56 in an expanded geometry. - The collapsed geometry permits insertion of the
structure 56 into theinterior volume 30 of a targetedvertebral body 26, asFIG. 6 shows. Thestructure 56 can be introduced into theinterior volume 30 in various ways.FIG. 6 shows the insertion of thestructure 56 through a single lateral access, which extends through a lateral side of thevertebral body 12. - Lateral access is indicated, for example, if a compression fracture has collapsed the
vertebral body 26 below the plane of thepedicle 42, or for other reasons based upon the preference of the physician. Lateral access can be performed either with a closed, minimally invasive procedure or with an open procedure. Of course, depending upon the intervening anatomy, well known in the art, lateral access may not be the optimal access path for treatment of vertebrae at all levels of the spine. - The
catheter tube 50 includes an interior lumen 80 (seeFIG. 4 ). Thelumen 80 is coupled at the proximal end of thecatheter tube 50 to a pressurized source of fluid, e.g., saline. A syringe containing the fluid can comprise the pressure source. Thelumen 80 conveys the fluid into thestructure 56 under pressure. As a result, thewall 58 expands, asFIGS. 5 and 7 show. - The fluid is preferably rendered radio-opaque, to facilitate visualization as it enters the
structure 56. For example, Renograffin™ can be used for this purpose. Because the fluid is radio-opaque, expansion of thestructure 56 can be monitored fluoroscopically or under CT visualization. Using real time MRI, thestructure 56 may be filled with sterile water, saline solution, or sugar solution, free of a radiopaque material. If desired, other types of visualization could be used, with thetool 48 carrying compatible reference markers. Alternatively, the structure could incorporate a radiopaque material within the material of the structure, or the structure could be painted or dusted with a radiopaque material. - Expansion of the
wall 58 enlarges thestructure 56, desirably compactingcancellous bone 32 within the interior volume 30 (seeFIG. 7 ) and/or causing desired displacement of cortical bone. The compaction ofcancellous bone 32 forms acavity 60 in theinterior volume 30 of the vertebral body 26 (seeFIG. 8 ). As will be described later, a fillingmaterial 62 can be safely and easily introduced into thecavity 60 which the compactedcancellous bone 32 forms. In one embodiment, expansion of thestructure 56 desirably forms a region of compacted cancellous bone which substantially surrounds thecavity 60. This region desirably comprises a physical barrier which limits leakage of the fillingmaterial 62 outside thevertebral body 26. In an alternate embodiment, the expansion of thestructure 56 also desirably pressescancellous bone 32 into small fractures which may be present in cortical bone, thereby reducing the possibility of the fillingmaterial 62 exiting through the cortical wall. In another alternative embodiment, the expansion of thestructure 56 desirably flattens veins in the vertebral body that pass through the cortical wall (e.g., the basivertebral vein), resulting in less opportunity for fillingmaterial 62 to extravazate outside the vertebral body through the veinous structure in the cortical wall. - Alternatively, expansion of the
structure 56 will compress less dense and/or weaker regions of the cancellous bone, which desirably increases the average density and/or overall strength of the remaining cancellous bone. - The compaction of cancellous bone by the
structure 56 can also exert interior force upon cortical bone. Alternatively, thestructure 56 can directly contact the cortical bone, such that expansion and/or manipulation of the structure will cause displacement of the cortical bone. Expansion of thestructure 56 within thevertebral body 26 thereby makes it possible to elevate or push broken and compressed bone back to or near its original prefracture position. - The
structure 56 is preferably left inflated within thevertebral body 26 for an appropriate waiting period, for example, three to five minutes, to allow some coagulation inside thevertebral body 26 to occur. After the appropriate waiting period, the physician collapses and removes thestructure 56. AsFIG. 8 shows, upon removal of thestructure 56, the formedcavity 60 desirably remains in theinterior volume 30. - As
FIG. 9A shows, the physician next introduces a fillingmaterial 62 into the formedcavity 60. The fillingmaterial 62 can comprise a material that resists torsional, tensile, shear and/or compressive forces within thecavity 60, thereby providing renewed interior structural support for thecortical bone 28. For example, thematerial 62 can comprise a flowable material, such as bone cement, allograft tissue, autograft tissue, or hydroxyapatite, synthetic bone substitute, which is introduced into thecavity 60 and which, in time, sets to a generally hardened condition. The material 62 can also comprise a compression-resistant material, such as rubber, polyurethane, cyanoacrylate, or silicone rubber, which is inserted into thecavity 60. The material 62 can also comprise a semi-solid slurry material (e.g., a bone slurry in a saline base), which is either contained within a porous fabric structure located in thecavity 60 or injected directly into thecavity 60, to resist compressive forces within thecavity 60. Alternatively, thematerial 62 could comprise stents, reinforcing bar (Re-Bar) or other types of internal support structures, which desirably resist compressive, tensile, torsional and/or shear forces acting on the bone and/or filler material. - The filling
material 62 may also comprise a medication, or a combination of medication and a compression-resistant material, as described above. - Alternatively, the filling
material 62 can comprise a bone filling material which does not withstand compressive, tensile, torsional and/or shear forces within the cavity. For example, where the patient is not expected to experience significant forces within the spine immediately after surgery, such as where the patient is confined to bed rest or wears a brace, the fillingmaterial 62 need not be able to immediately bear loads. Rather, the fillingmaterial 62 could provide a scaffold for bone growth, or could comprise a material which facilitates or accelerates bone growth, allowing the bone to heal over a period of time. As another alternative, the filling material could comprise a resorbable or partially-resorbable source of organic or inorganic material for treatment of various bone or non-bone-related disorders including, but not limited to, osteoporosis, cancer, degenerative disk disease, heart disease, acquired immune deficiency syndrome (AIDS) or diabetes. In this way, the cavity and/or filler material could comprise a source of material for treatment of disorders located outside the treated bone. - In an alternative embodiment, following expansion, the
expandable structure 56 can be left in thecavity 60. In this arrangement,flowable filling material 62 is conveyed into thestructure 56, which serves to contain thematerial 62. Thestructure 56, filled with thematerial 62, serves to provide the renewed interior structural support function for thecortical bone 28. - In this embodiment, the
structure 56 can be made from an inert, durable, non-degradable plastic material, e.g., polyethylene and other polymers. Alternatively, thestructure 56 can be made from an inert, bio-absorbable material, which degrades over time for absorption or removal by the body. - In another embodiment, the filling
material 62 itself can serve as the expansion medium for thestructure 56, to compact cancellous bone and form thecavity 60, to thereby perform both compaction and interior support functions. Alternatively, thestructure 56 can be first expanded with another medium to compact cancellous bone and form thecavity 60, and the fillingmaterial 62 can be subsequently introduced after the expansion medium is removed fromstructure 56 to provide the interior support function. As another alternative, the filling material could comprise a two-part material including, but not limited to, settable polymers or calcium alginate. If desired, one part of the filling material could be utilized as the expansion medium, and the second part added after the desired cavity size is achieved. - The
structure 56 can be made from a permeable, semi-permeable, or porous material, which allows the transfer of medication contained in the fillingmaterial 62 into contact with cancellous bone through the wall of thestructure 56. If desired, the material can comprise a membrane that allows osmotic and/or particulate transfer through the material, or the material can comprise a material that allows the medication to absorb into and/or diffuse through the material. Alternatively, medication can be transported through a porous wall material by creating a pressure differential across the wall of thestructure 56. - As another alternative, fluids, cells and/or other materials from the patient's body can pass and/or be drawn through the material into the structure for various purposes including, but not limited to, fluid/cellular analysis, bony ingrowth, bone marrow harvesting, and/or gene therapy (including gene replacement therapy).
- III. Instruments for Establishing Bone Access
- During a typical bilateral procedure, a patient lies on an operating table. The patient can lie face down on the table, or on either side, or at an oblique angle, depending upon the physician's preference.
- A. Use of Hand Held Instruments
- For each access (see
FIG. 10A ), the physician introduces aspinal needle assembly 70 into soft tissue ST in the patient's back. Under radiologic or CT monitoring, the physician advances thespinal needle assembly 70 through soft tissue down to and into the targetedvertebral body 26. The physician can also employ stereotactic instrumentation to guide advancement of thespinal needle assembly 70 and subsequent tools during the procedure. In this arrangement, the reference probe for stereotactic guidance can be inserted through soft tissue and implanted on the surface of the targeted vertebral body. The entire procedure can also be monitored using tools and tags made of non-ferrous materials, e.g., plastic or fiber composites, such as those disclosed in U.S. Pat. Nos. 5,782,764 and 5,744,958, which are each incorporated herein by reference, which would be suitable for use in a computer enhanced, whole-room MRI environment. - The physician will typically administer a local anesthetic, for example, lidocaine, through the
assembly 70. In some cases, the physician may prefer other forms of anesthesia. - The physician directs the
spinal needle assembly 70 to penetrate thecortical bone 28 and thecancellous bone 32 through the side of thevertebral body 26. Preferably the depth of penetration is about 60% to 95% of thevertebral body 26. - The physician holds the
stylus 72 and withdraws thestylet 74 of thespinal needle assembly 70. AsFIG. 10B shows, the physician then slides aguide pin instrument 76 through thestylus 72 and into thecancellous bone 32. The physician now removes thestylus 72, leaving theguide pin instrument 76 deployed within thecancellous bone 32. - The physician next slides an
obturator instrument 78 over theguide pin instrument 76, distal end first, asFIG. 10C shows. The physician can couple theobturator instrument 78 to ahandle 80, which facilitates manipulation of theinstrument 78. - The physician makes a small incision in the patient's back. The physician twists the
handle 80 while applying longitudinal force to thehandle 80. In response, theobturator instrument 78 rotates and penetrates soft tissue through the incision. The physician may also gently tap thehandle 80, or otherwise apply appropriate additional longitudinal force to thehandle 80, to advance theobturator instrument 78 through the soft tissue along theguide pin instrument 76 down to the cortical bone entry site. The physician can also tap thehandle 80 with an appropriate striking tool to advance theobturator instrument 78 into a side of thevertebral body 26 to secure its position. - The
obturator instrument 78 shown inFIG. 10C has an outside diameter that is generally well suited for establishing a lateral access. However, if access is desired through the more narrow region of thevertebral body 26, e.g., a pedicle 42 (called transpedicular access), the outside diameter of theobturator instrument 78 can be reduced. The reduced diameter of theobturator instrument 78 mediates against damage or breakage of thepedicle 42. It should be understood that the disclosed methods and devices are well suited for use in conjunction with other approach paths, such as pedicular, extra-pedicular, posterolateral and anterior approaches, with varying results. - The physician then proceeds to slide the
handle 80 off theobturator instrument 78 and to slide acannula instrument 84 over theguide pin instrument 76 and, further, over theobturator instrument 78. If desired, the physician can also couple thehandle 80 to thecannula instrument 84, to apply appropriate twisting and longitudinal forces to rotate and advance thecannula instrument 84 through soft tissue ST over theobturator instrument 78. When thecannula instrument 84 contactscortical bone 28, the physician can appropriately tap thehandle 80 with a striking tool to advance the end surface into the side of thevertebral body 26 to secure its position. - The physician now withdraws the
obturator instrument 78, sliding it off theguide pin instrument 76, leaving theguide pin instrument 76 and thecannula instrument 84 in place. When a reduceddiameter obturator instrument 78 is used, the physician can remove an inner centering sleeve (not shown). - As
FIG. 10D shows, the physician slides adrill bit instrument 88 over theguide pin instrument 76, distal end first, through thecannula instrument 84, until contact between the machined or cuttingedge 90 of thedrill bit instrument 88 andcortical bone 28 occurs. The physician then couples thedrill bit instrument 88 to thehandle 80. - Guided by X-ray (or another external visualizing system), the physician applies appropriate twisting and longitudinal forces to the
handle 80, to rotate and advance the machinededge 90 of thedrill bit instrument 88 to open a lateral passage PLA through thecortical bone 28 and into thecancellous bone 32. The drilled passage PLA preferably extends no more than 95% across thevertebral body 26. - Further details regarding the formation of cavities within cancellous bone, which are not symmetric with relation to the axis of a vertebral body, can be found in U.S. Pat. No. 5,972,018, entitled Expandable Asymmetric Structures for Deployment in Interior Body Regions, which is incorporated herein by reference.
- Once the passage PLA in
cancellous bone 32 has been formed, the physician removes thedrill bit instrument 88 and theguide pin instrument 76, leaving only thecannula instrument 84 in place, asFIG. 10E shows. The passage PLA made by thedrill bit instrument 88 remains. Subcutaneous lateral access to thecancellous bone 32 has been accomplished. - If desired, other tools can be used to establish subcutaneous access to the targeted bone, such as the tools described in copending U.S. patent application Ser. No. 09/421,635, filed Oct. 19, 1999, and entitled Hand-Held Instruments that Access Interior Body Regions, which is incorporated herein by reference.
- B. Filling the Cavity
- Upon formation of the cavity 64, the physician can fill a
syringe 112 with the desired volume of fillingmaterial 62, a batch of which has been previously prepared. When using anexpandable structure 56 having a preformed configuration, the cavity volume created is known. The physician thereby knows the desired volume ofmaterial 62 to place in thesyringe 112 for each cavity formed in thevertebral body 26. - The physician attaches a
nozzle 114 to the filledsyringe 112. The physician then proceeds to deflate and remove the expandable structure through the associatedcannula instrument 84 and to fill the associated cavity with thematerial 62. - To fill the cavity, the physician inserts the
nozzle 114 through the associated cannula instrument a selected distance into the cavity, guided, e.g., byexterior markings 116 or by real-time fluoroscope or x-ray or MRI visualization. The physician operates thesyringe 112 to cause thematerial 62 to flow through and out of thenozzle 114 and into the cavity portion. AsFIG. 10H shows, thenozzle 114 may posses a uniform interior diameter, sized to present a distal end dimension that facilitates insertion into the vertebral body. To reduce the overall flow resistance, however, thenozzle 114 can possess an interior diameter (e.g., seeFIG. 11A ) that steps down from a larger diameter at itsproximal region 118 to a smaller diameter near itsdistal end 120. This reduces the average interior diameter of thenozzle 114 to thereby reduce the overall flow resistance. Reduced flow resistance permits more viscous material to be conveyed into the vertebral body. The more viscous material is desirable, because it has less tendency to exude from the bone compared to less viscous materials. In addition to the embodiment shown inFIG. 11A , various other constructions are possible to create a reduced diameter nozzle or tool for introducing material into bone. For example, as shown inFIG. 11B , atool 160 can possess aninterior lumen 162 that gradually tapers from a larger interior diameter to a smaller interior diameter. Or, as shown inFIG. 11C , atool 164 can possess aninterior lumen 166 that steps from a larger to a smaller interior diameter. An associated cannula instrument 168 (seeFIG. 11C ) may also include a reduced diameter passage, which is downsized to accommodate the reduced diameter tool and to present less flow resistance to filling material conveyed through the cannula instrument. - The reduced diameter tool may also be used in association with a vertebroplasty procedure, which injects cement under pressure into a vertebral body, without prior formation of a cavity.
- The filling
material 62 may contain a predetermined amount of a radiopaque material, e.g., barium or tungsten, sufficient to enable visualization of the flow ofmaterial 62 into the cavity portion. The amount of radiopaque material (by weight) is desirably at least 10%, more desirably at least 20%, and most desirably at least 30%. The physician can thereby visualize the cavity filling process. - As
material 62 fills the cavity portion, the physician withdraws thenozzle 114 from the cavity portion and into thecannula instrument 84. Thecannula instrument 84 channels the material flow toward the cavity portion. The material flows in a stream into the cavity portion. - As
FIG. 10H shows, agasket 122 may be provided about thecannula instrument 84 to seal about the access passage PLA. Thegasket 122 serves to prevent leakage of the material about thecannula instrument 84. - The physician operates the
syringe 112 to expel the material 62 through thenozzle 114, first into the cavity portion and then into thecannula instrument 84. Typically, at the end of the syringe injection process,material 62 should extend from the cavity and occupy about 40% to 50% of thecannula instrument 84. Alternatively, the physician can utilize thesyringe 112 to fill the lumen of thenozzle 114 and/orcannula instrument 84 withmaterial 62, and then utilize atamping instrument 124 to expel the material from the lumen into the vertebral body. - When a desired volume of
material 62 is expelled from thesyringe 112, the physician withdraws thenozzle 114 from thecannula instrument 84. The physician may first rotate thesyringe 112 andnozzle 114, to break loose the material 62 in thenozzle 114 from the ejected bolus ofmaterial 62 occupying thecannula instrument 84. - As
FIG. 10I shows, the physician next advances a tampinginstrument 124 through thecannula instrument 84. The distal end of the tampinginstrument 124 contacts the residual volume ofmaterial 62 in thecannula instrument 84. Advancement of the tampinginstrument 124 displaces progressively more of theresidual material 62 from thecannula instrument 84, forcing it into the cavity portion. The flow ofmaterial 62 into the cavity portion, propelled by the advancement of the tampinginstrument 124 in thecannula instrument 84, serves to uniformly distribute and compact thematerial 62 inside the cavity portion, into other cavities and/or openings within the bone, and into fracture lines, without the application of extremely high pressure. - The use of the
syringe 112,nozzle 114, and the tampinginstrument 124 allows the physician to exert precise control when filling the cavity portion withmaterial 62. The physician can immediately adjust the volume and rate of delivery according to the particular local physiological conditions encountered. The application of low pressure, which is uniformly applied by thesyringe 112 and the tampinginstrument 124, allows the physician to respond to fill volume and flow resistance conditions in a virtually instantaneous fashion. The chance of overfilling and leakage ofmaterial 62 outside the cavity portion is significantly reduced. - Moreover, the tamping
instrument 124 will desirably permit highly-controlled injection ofmaterial 62 under higher injection pressures as well. For example,FIG. 12 depicts amaterial injection instrument 500 comprising a reduceddiameter nozzle 180 and astylet 182. Thestylet 182 is desirably sized to pass through the reduceddiameter nozzle 180. In turn, thenozzle 180 is desirably sized to pass through thecannula instrument 184. For material strength, thenozzle 180 can be formed from a substantially rigid metal material, e.g., stainless steel or a high strength plastic. - The
stylet 182 includes ahandle 192, which rests on theproximal connector 186 of the nozzle when thestylet 182 is fully inserted into thenozzle 180. When the handle is rested, the distal ends of thestylet 182 andnozzle 180 align. The presence of thestylet 182 inside thenozzle 180 desirably closes the interior bore. - In use, the
nozzle 180 can be coupled to thesyringe 104 and inserted through thecannula instrument 184 into a material-receiving cavity (not shown) formed within a bone.Material 62 in thesyringe 104 is injected into thenozzle 180 where it desirably passes into the bone. When a sufficient amount ofmaterial 62 is injected into the bone and/ornozzle 180, thesyringe 104 may be removed from thenozzle 180. - The
stylet 182 can then be inserted into thenozzle 180, and advanced through the nozzle, desirably pressurizing thematerial 62 and pushing it out of thenozzle 180. In one disclosed embodiment, thestylet 182 has a diameter of approximately 0.118 in. The cross-sectional area of thisstylet 182 is approximately 0.010936 in2, and thenozzle 180 desirably contains approximately 1.5 cc of filler material. In an alternate embodiment, thestylet 182 has a diameter of approximately 0.136 in. - The
nozzle 180 andstylet 182 can be used in a similar manner as acombination ram 183 to push thefiller material 62 through thecannula instrument 184 into the bone. For example, wherefiller material 62 is within thecannula instrument 184, the insertion of theram 183 into thecannula 184 will desirably displace thematerial 62, forcing the material 62 from the distal end of thecannula 184 into the bone. In one embodiment, the diameter of theram 183 is approximately 0.143 in. As theram 183 advances through thecannula 184, it will desirably displace thefiller material 62 in thecannula 184. Theram 183, therefore, acts as a positive displacement “piston” or “pump,” which permits the physician to accurately gauge the precise amount offiller material 62 that is injected into the bone. - If the filler material is very viscous, this material will typically strongly resist being pumped through a delivery system. Generally, the greater distance the filler material must travel through the system, the greater the pressure losses will be from such factors as viscosity of the material and frictional losses with the walls. In order to account for these losses, existing delivery systems typically highly pressurize the filler material, often to many thousands of pounds of pressure. Not only does this require stronger pumps and reinforced fittings for the delivery system, but such systems often cannot dispense filler material in very precise amounts. Moreover, if the filler material hardens over time, the system must produce even greater pressures to overcome the increased flow resistance of the material.
- The disclosed systems and methods obviate and/or reduce the need for complex, high pressure injection systems for delivery of filler materials. Because the disclosed
ram 183 travels subcutaneously through thecannula 184, and displacesfiller material 62 out the distal end of thecannula 184, the amount of filler material being pushed by the ram 183 (and the total amount offiller material 62 within the cannula 184) progressively decreases as filler material is injected into the bone. This desirably results in an overall decrease in resistance to movement of the ram during injection. Moreover, because the amount of material being pushed by theram 183 decreases, an increase in the flow resistance of the curing filler material does not necessarily require an increase in injection pressure. In addition, because theram 183 travels within thecannula 184, and can travel percutaneously to the injection site, the filler material need only be “pumped” a short length before it exits the cannula and enters the bone, further reducing the need for extremely high pressures. If injection of additional filler material is required, the ram can be withdrawn from the cannula, additional filler material can be introduced into the cannula, and the process repeated. Thus, the present arrangement facilitates injection of even extremely viscous materials under well controlled conditions. Moreover, by utilizing varying diameters of cannulas, nozzles and stylets in this manner, a wide range of pressures can be generated in thefiller material 62. If desired, the disclosed devices could similarly be used to inject filler material through a spinal needle assembly directly into bone, in a vertebroplasty-like procedure, or can be used to fill a cavity created within the bone. - If desired, after the physician has filled the cavity with
material 62, the physician may choose to continue injectingadditional material 62 into the vertebral body. Depending upon the local conditions within the bone, this additional material may merely increase the volume of the cavity (by further compacting cancellous bone), or may travel into the compressed and/or uncompressed cancellous bone surrounding the cavity, which may serve to further compress cancellous bone and/or further enhance the compressive strength of the vertebral body. - When the physician is satisfied that the
material 62 has been amply distributed inside the cavity portion, the physician withdraws the tampinginstrument 124 from thecannula instrument 84. The physician preferably first twists the tampinginstrument 124 to cleanly break contact with thematerial 62. - Once the cavity is filled and tamped in the above described manner, the
cannula instrument 84 can be withdrawn and the incision site sutured closed. - Eventually the
material 62, if cement, will harden to a rigid state within the cavity 64. The capability of the vertebral body to withstand loads has thereby been improved. -
FIGS. 9B through 9D depict an alternate method of filling acavity 60 formed within a vertebral body. In this embodiment, acannula instrument 84 has been advanced through apedicle 42 of the vertebral body by, providing access to acavity 60 formed therein. Anozzle 180 is advanced into the vertebral body, with the distal tip of thenozzle 180 desirably positioned near the anterior side of thecavity 60.Filler material 62 is slowly injected through thenozzle 180 into thecavity 60. As injection offiller material 62 continues, thenozzle 180 is withdrawn towards the center of thecavity 60. SeeFIG. 9 c. Desirably, as thenozzle 180 is withdrawn, the distal tip of thenozzle 180 will remain substantially in contact with the growing bolus offiller material 62. Once thenozzle 180 is positioned near the center of thecavity 60,additional filler material 62 is injected through thenozzle 180 to substantially fill thecavity 60. The nozzle is then removed from thecavity 60. - If desired, the nozzle can be attached to a syringe 104 (see
FIG. 12 ) containing filler material. In one embodiment, thesyringe 104 will contain an amount of filler material equal to the volume of thecavity 60 formed within the vertebral body, with the nozzle containing an additional 1.5 cc of filler material. In this embodiment, thecavity 60 will initially be filled with filler material expelled from thesyringe 104. Once exhausted, thesyringe 104 can be removed from thenozzle 180, astylet 182 inserted into thenozzle 180, and the remaining filler material within thenozzle 180 pushed by thestylet 182 into the vertebral body. Desirably, the additional filler material from thenozzle 180 will extravazate into the cancellous bone, compress additional cancellous bone and/or slightly increase the size of thecavity 60. - The disclosed method desirably ensures that the cavity is completely filled with filler material. Because the patient is often positioned front side (anterior side) down during the disclosed procedures, the anterior section of the cavity is often the lowest point of the cavity. By initially filling the anterior section of the cavity with filler material, and then filling towards the posterior side of the cavity, fluids and/or suspended solids within the cavity are desirably displaced by the filler material and directed towards the posterior section of the cavity, where they can exit out the cannula. In this manner, trapping of fluids within the cavity and/or filler material is avoided and a complete and adequate fill of the vertebral body is ensured.
- If desired, the filler material can be allowed to harden and/or cure before injection into the vertebral body. For example, in one embodiment, the filler material comprises bone cement, which is allowed to cure to a glue or putty-like state before being injected into the cavity. In this embodiment, the cement would desirably have a consistency similar to toothpaste as the cement begins to extrude from the nozzle.
- The selected
material 62 can also be an autograft or allograft bone graft tissue collected in conventional ways, e.g., in paste form (see Dick, “Use of the Acetabular Reamer to Harvest Autogenic Bone Graft Material: A Simple Method for Producing Bone Paste,” Archives of Orthopaedic and Traumatic Surgery (1986), 105: 235-238), or in pellet form (see Bhan et al, “Percutaneous Bone Grafting for Nonunion and Delayed Union of Fractures of the Tibial Shaft,” International Orthopaedics (SICOT) (1993) 17: 310-312). Alternatively, the bone graft tissue can be obtained using a Bone Graft Harvester, which is commercially available from SpineTech. Using a funnel, the paste or pellet graft tissue material is loaded into thecannula instrument 84 30. The tampinginstrument 124 is then advanced into thecannula instrument 84 in the manner previously described, to displace the paste or pellet graft tissue material out of thecannula instrument 84 and into the cavity portion. - The selected
material 62 can also comprise a granular bone material harvested from coral, e.g., ProOsteon™ calcium carbonate granules, available from Interpore. The granules are loaded into thecannula instrument 84 using a funnel and advanced into the cavity using the tampinginstrument 124. - The selected
material 62 can also comprise demineralized bone matrix suspended in glycerol (e.g., Grafton™ allograft material available from Osteotech), or SRS® calcium phosphate cement available from Norian. These viscous materials, like the bone cement previously described, can be loaded into thesyringe 112 and injected into the cavity using thenozzle 114, which is inserted through thecannula instrument 84 into the cavity portion. The tampinginstrument 124 is used to displace residual material from thecannula instrument 84 into the cavity portion, as before described. - The selected
material 62 can also be in sheet form, e.g. Collagraft® material made from calcium carbonate powder and collagen from bovine bone. The sheet can be rolled into a tube and loaded by hand into thecannula instrument 84. The tampinginstrument 124 is then advanced through thecannula instrument 84, to push and compact the material in the cavity portion. - C. Multi-Stage Injection Instruments
-
FIGS. 13A and 13B depict one embodiment of a filler instrument for introducing a desired amount of filling material into a bone or other vertebral body.Filler instrument 600 comprises afirst section 605 and asecond section 610. The first andsecond sections first section 605 being in fluid communication with the interior of thesecond section 610. - The
first section 605 has a first interiorcross-sectional area 615, and thesecond section 610 has a second interiorcross-sectional area 620. Desirably, the first interiorcross-sectional area 615 will be greater than the second interiorcross-sectional area 620. In the disclosed embodiment, thefirst section 605 comprises a cylindrical, hollow, tubular member having an interior diameter of 0.358 inches and a length of 2.58 inches, and the second section comprises a cylindrical, hollow, tubular member having an interior diameter of 0.175 inches and a length of 8.84 inches. - A dispensing
opening 640 is formed at thedistal tip 645 of thesecond section 610. A first ram opening 650 is formed at the proximal end of thefirst section 605. If desired, aflange 655 can be formed on the outer portion of thefirst section 605. If also desired, the transition from thefirst section 605 to thesecond section 610 can neck down or taper, as shown inFIG. 13A . -
FIGS. 14A through 14D depict afirst ram assembly 700 suitable for use with the describedfiller instrument 600. Thefirst ram assembly 700 comprises afirst plunger 705 sized to pass through the interior of thefirst section 605. Aseal 710, such as an O-ring, is secured to thedistal end 715 of thefirst plunger 705 in a manner well known in the art. Desirably, theseal 710 will slidingly engage with the inner walls of thefirst section 605 to seal the proximal end of thefirst section 605 as thefirst plunger 705 advances therethrough. Desirably, theseal 710 will comprise Teflon, natural rubber, or other type of sealant material. It should be noted that, while the cross-section of the disclosed plunger is circular (seeFIG. 14B ), plungers having other cross-sectional shapes, such as triangular or rectangular shapes, could similarly be utilized with varying results. - If desired, a
ram flange 725 can be formed on the distal portion of thefirst plunger 705. Desirably, theram flange 725 will abut and/or contact theflange 655 when the distal end of thefirst plunger 705 reaches a desired position near or abutting the distal end of thefirst section 605. Thefirst ram assembly 700 further comprises a second ram opening 720 extending longitudinally through thefirst plunger 705. Desirably, the size and shape of the cross-sectional area of the second ram opening 720 will be less than or approximate the size and shape of the second interiorcross-sectional area 620. In the disclosed embodiment, thefirst ram assembly 700 is 2.62 inches long, thefirst plunger 705 having an outer diameter of 0.357 inches, and the inner diameter of the second ram opening 720 is 0.115 inches. -
FIG. 15 depicts asecond ram assembly 750 suitable for use with thefirst ram assembly 700 and thefiller instrument 600. Thesecond ram assembly 750 comprises asecond plunger 755, and aknob 760 secured to the proximal end of thesecond plunger 755. Thesecond plunger 755 is desirably sized to pass through the second ram opening 720 and thesecond section 610. In one embodiment, the second ram assembly further comprises anotch 765. A retaining clip 800 (seeFIGS. 16A through 16C ) desirably releasably secures thesecond ram assembly 750 within the second ram opening 755. In the disclosed embodiment, thesecond ram assembly 750 is 11.8 inches long, thesecond plunger 755 has an outer diameter of 0.113 inches, and thenotch 765 is located approximately 2.62 inches from the distal tip of thesecond plunger 755. - For material strength, the various components of the
filler instrument 600 can comprise a substantially rigid metal, plastic or ceramic material, e.g., stainless steel or a high strength plastic. In the disclosed embodiment, thefiller instrument 600 and second ram assembly comprise 303 stainless steel, and the first ram assembly comprises Delrin® plastic (available commercially from DuPont Corporation). - When injection of filler material is desired, the
filler instrument 600 is filled with filler material (not shown) such as bone cement or PMMA. Thesecond ram assembly 750 is secured within the first ram assembly with the retainingclip 800. Thedistal end 715 of thefirst plunger 705 is then inserted into thefirst ram opening 650. - As the
first plunger 705 is advanced through thefirst section 605 of thefiller instrument 600, filler material in thefirst section 605 is displaced by theplunger 705, which in turn forces material in thesecond section 610 out through the dispensingopening 640. Passage of a significant amount of filler material through the second ram opening 755 is prevented by the presence of thesecond plunger 755, which is desirably held in position by the retainingclip 800. As thedistal end 715 approaches the distal end of thefirst section 605, desirably substantially all of the filler material will be displaced from thefirst section 605 into thesecond section 610 and/or out the dispensingopening 640. - The retaining
clip 800 is then released, and thesecond plunger 755 advanced through the distal end of thefirst section 605 and into thesecond section 610. Desirably, the shape and size of the cross-sectional area of thesecond plunger 755 will approximate the shape and size of thecross-sectional area 620 of thesecond section 610, such that thesecond plunger 755 displaces substantially all of the filler material in thesecond section 610 as thesecond plunger 755 advances. Desirably, once the distal end of thesecond plunger 755 reaches the dispensingopening 640, substantially all of the filler material within the first andsecond sections filler instrument 600. - By utilizing first and second sections of different cross-sectional areas, and first and second plungers to displace the filler material, the present invention facilitates dispensing of a substantial amount of filler material from a single filler instrument. Because the viscosity of PMMA and various other types of filler materials typically increases with time during the dispensing process, it becomes progressively harder to dispense filler material over time. By utilizing a plunger of larger cross-sectional area to initiate the filling operation, when the filler material is less viscous, the present invention allows dispensing of a significant amount of filler material. However, as the filler material cures, and becomes more viscous, the reduced cross-sectional area of the second plunger allows continued dispensing of the more viscous filler material, even when it is in a highly viscous state. Moreover, because the second section is of reduced cross-sectional area, its reduced profile will desirably allow the distal tip of the filler instrument to be introduced through the cannula and/or soft tissues and directly into the targeted vertebral body, while still providing a sufficient reservoir of filler material to accomplish the goals of augmenting and/or repairing the targeted bone. Moreover, because the tool need not be refilled and/or “switched out” during the dispensing operation, but can rather remain in place and dispense the entire required amount of bone filler for the procedure, the potential for trapping air within the vertebral body and/or bolus of cement is significantly reduced.
- The present invention also greatly facilitates the ability of the physician to immediately shift from a higher volume, lower pressure cement flow to a lower volume, higher pressure cement flow. As the first plunger is being depressed, and cement is being injected into the vertebral body, the physician may determine that a more controlled, higher pressure and/or lower volume flow of cement is needed. Alternatively, the cement may cure or harden to a point where further movement of the first plunger is extremely difficult and/or impossible to effect. One embodiment of the present invention permits the physician to advance the second plunger into the second section, even when the distal end of the first plunger is not near and/or abutting the distal end of the first section. Once the second plunger passes through the cement in the first section, and enters the second section, cement will be displaced from the second section. Due to the decreased cross-sectional area of the second plunger and second section (as compared to the first plunger and first section), the second plunger is easier to push through the cement in the first section and cement can more easily be dispensed from the second section at higher pressures and/or lower volumes.
- The disclosed filler instrument may be used to introduce filler material through a cannula into a cavity created within a bone, or may be used with vertebroplasty-type techniques to introduce filler material directly into the vertebral body without prior formation of a cavity. Where prior cavity-formation is not required and/or desired, and vertebroplasty-like techniques will be used, the filler instrument can incorporate a needle-point at the distal end of the instrument, or the diameter of the second section can be significantly reduced to allow passage of the instrument through the lumen of a spinal needle assembly. Alternatively, one or more of the sections of the filler instrument could comprise a commercially available spinal needle assembly (such as a Bone Marrow Biopsy Needle No. 508627, available from Becton Dickinson & Co., Franklin Lakes, N.J., 07417). If desired, one or more plunger assemblies of varying sizes and lengths could be provided to accommodate differing spinal needle assemblies.
- If desired, the filler instrument can be pre-loaded with filler material, introduced through soft tissues and into the vertebral body, used to inject filler material, and removed, quickly and easily without need for tool exchanges during the operation. For example, where the end plates of the vertebral body have depressed to a point where an expandable structure cannot be safely inserted and/or expanded within the vertebral body, bone cement can be injected under pressure through a needle directly into the cancellous bone of the vertebral body (without cavity formation). The bone cement penetrates cancellous bone.
- To reduce flow resistance to the filler material, the filler instrument can possess an increasing interior diameter, as shown in
FIGS. 11A, 11B , or 11C. The reduced flow resistance would make possible the use of more viscous cement, to thereby further reduce the possibility that the cement would exude from the vertebral body. -
FIGS. 17A through 17D andFIG. 18 depict an alternate embodiment of a filler instrument constructed in accordance with the teachings of the present invention. Because many of the features of this embodiment are similar to those previously described, like reference numerals will be used to describe similar components. In this embodiment, the first ram assembly 700A further comprises an increased cross-sectional tip opening 850 within the distal end 715A of the assembly 700A. This tip opening 850 corresponds to a increasedcross-sectional plunger tip 855 on thesecond plunger 755. - During use of the filler instrument 600A, while the first plunger 705A is advanced, the
plunger tip 855 seats within thetip opening 850, desirably preventing the second plunger 750A from moving axially in response to the increased pressure of the filler material. If desired, a clip (not shown) can be utilized to secure the second plunger to the first plunger. Once the first plunger 705A has been advanced to its desired position, the clip (not shown) can be removed from the notch 765A, and the second plunger 750A advanced as previously described. -
FIGS. 19A through 19D depict another alternate embodiment of a filler instrument 600B constructed in accordance with the teachings of the present invention. Because many of the features of this embodiment are similar to those previously described, like reference numerals will be used to describe similar components. In this embodiment, the first ram assembly 700B comprises acheck valve 900 located at thedistal tip 715 of the assembly 700B. Thecheck valve 900 will desirably prevent filler material from travelling through the second ram opening 720B as the first plunger 705B is advanced. Once the first ram assembly 700B is advanced to its desired position, and the second plunger assembly is advanced through the second ram opening, thecheck valve 900 permits passage of the second plunger into the first and second sections as previously described. - The features of the invention are set forth in the following claims.
Claims (10)
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Also Published As
Publication number | Publication date |
---|---|
EP1303236B1 (en) | 2008-12-03 |
CA2415389A1 (en) | 2002-03-07 |
HK1057690A1 (en) | 2004-04-16 |
US7252671B2 (en) | 2007-08-07 |
AU2001277885A1 (en) | 2002-03-13 |
EP1303236A2 (en) | 2003-04-23 |
JP2004507312A (en) | 2004-03-11 |
WO2002017801A3 (en) | 2002-08-29 |
US20020099384A1 (en) | 2002-07-25 |
CN100486536C (en) | 2009-05-13 |
JP4809572B2 (en) | 2011-11-09 |
KR20030029621A (en) | 2003-04-14 |
DE60136815D1 (en) | 2009-01-15 |
US20040049203A1 (en) | 2004-03-11 |
US6641587B2 (en) | 2003-11-04 |
CN1251651C (en) | 2006-04-19 |
CN1441655A (en) | 2003-09-10 |
CN1820722A (en) | 2006-08-23 |
CA2415389C (en) | 2009-02-17 |
ATE415915T1 (en) | 2008-12-15 |
WO2002017801A2 (en) | 2002-03-07 |
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