US20100179556A1 - Methods for placing materials into bone - Google Patents
Methods for placing materials into bone Download PDFInfo
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- US20100179556A1 US20100179556A1 US12/731,571 US73157110A US2010179556A1 US 20100179556 A1 US20100179556 A1 US 20100179556A1 US 73157110 A US73157110 A US 73157110A US 2010179556 A1 US2010179556 A1 US 2010179556A1
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- instrument
- bone
- kit
- cannula
- cavity
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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
- A61F2/4601—Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor for introducing bone substitute, for implanting bone graft implants or for compacting them in the bone cavity
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- A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws, setting implements or the like
- A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
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- A61B17/8802—Equipment for handling bone cement or other fluid fillers
- A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
- A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum
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- A61B17/8852—Tools for expanding or compacting bones or discs or cavities therein capable of being assembled or enlarged, or changing shape, inside the bone or disc
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- A61B17/68—Internal fixation devices, including fasteners and spinal fixators, even if a part thereof projects from the skin
- A61B17/70—Spinal positioners or stabilisers ; Bone stabilisers comprising fluid filler in an implant
- A61B17/7097—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants
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- 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
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- 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
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- 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
- A61F2/28—Bones
- A61F2002/2835—Bone graft implants for filling a bony defect or an endoprosthesis cavity, e.g. by synthetic material or biological material
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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
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- 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
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- 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
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Surgery (AREA)
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- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Animal Behavior & Ethology (AREA)
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- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Physics & Mathematics (AREA)
- Physical Education & Sports Medicine (AREA)
- Fluid Mechanics (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Neurology (AREA)
- Pathology (AREA)
- Dentistry (AREA)
- Surgical Instruments (AREA)
- Prostheses (AREA)
- Materials For Medical Uses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Abstract
Cancellous bone is accessed through a subcutaneous access path in soft tissue. A cavity is formed in cancellous bone by a cavity forming tool that is advanced through the subcutaneous access path into cancellous bone and manipulated to form the cavity. A measured volume of bone filling material is delivered into the cavity through the subcutaneous access path by a nozzle having an interior bore defining an interior volume sized for containing bone filling material, which is advanced through the subcutaneous access path. A nested instrument is formed while clearing residual bone filling material from the interior bore by an auxiliary tool that can be manipulated independently of the nozzle, which is advanced through the interior bore of the nozzle.
Description
- This application is a divisional of co-pending U.S. patent application Ser. No. 10/617,976, filed Jul. 11, 2003, and entitled “Systems and Methods for Placing Materials into Bone,” which is, a divisional of U.S. patent application Ser. No. 09/804,107, filed Mar. 12, 2001, now U.S. Pat. No. 6,613,054, which is a divisional of U.S. patent application Ser. No. 09/134,323, filed Aug. 14, 1998, now U.S. Pat. No. 6,241,734.
- The invention generally relates to the treatment of bone conditions in humans and other animals.
- Injection devices similar to a household caulking gun are used to inject bone cement into bone. A typical bone cement injection device has a pistol shaped body, which supports a cartridge containing bone cement. A trigger actuates a spring-loaded ram, which forces a volume of bone cement in a viscous condition through a suitable nozzle and into the interior of a bone targeted for treatment. According to the teachings of U.S. Pat. Nos. 4,969,888 and 5,108,404, a cavity can be first formed by compacting cancellous bone inside the bone, into which the bone cement is injected. Conventional cement injection devices provide no opportunity to override the spring action and quickly terminate the flow of cement, should the cavity fill before the spring-actuated load cycle is completed. Furthermore, once the spring-actuated mechanism, is triggered, conventional cement injection devices do not permit the injection volume or inject rate to be adjusted or controlled in real time, in reaction to cancellous bone volume and density conditions encountered inside bone.
- In a clinical procedure called vertebroplasty, bone cement is injected at high pressure (typically, about 700 psi) into the interior of a vertebral body, without the prior formation of a cavity. Because high pressure is used, there is little opportunity to quickly and accurately adjust cement flow in reaction to bone volume and density conditions encountered. Momentum generated by high pressure-induced cement flow continues to propel cement into the targeted bone site even after termination of the high pressure.
- As a result of the relatively high pressure that conventional procedures rely upon, coupled with the effective lack of a short response time, the targeted bone interior can suddenly overfill. Excess filling material can be forced outside the bone interior, and into adjoining tissue regions, where the presence of filling material is not required or desired.
- For these and other reasons, there is a need for new systems and methods for placing material into bones, with greater rate and volume control, a faster response time, and without requiring the use of high pressure.
- The invention provides instruments, systems, and methods, which, in use, enable greater control over the placement of materials into bone.
- One aspect of the invention provides a method that accessed cancellous bone through a subcutaneous access path in soft tissue. A cavity is formed in cancellous bone by a cavity forming tool that is advanced through the subcutaneous access path into cancellous bone and manipulated to form the cavity. A measured volume of bone filling material is delivered into the cavity through the subcutaneous access path by a nozzle having an interior bore defining an interior volume sized for containing bone filling material, which is advanced through the subcutaneous access path. A nested instrument is formed while clearing residual bone filling material from the interior bore by an auxiliary tool that can be manipulated independently of the nozzle, which is advanced through the interior bore of the nozzle.
- The bone filling material can comprise medication or a material that sets to a hardened condition e.g., bone cement, or autograft tissue, or allograft tissue, or synthetic bone substitute, or combinations thereof.
- 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 plane view of a kit housing a system of functional instruments, which, in use, gain subcutaneous access to the inside of a bone to compact cancellous bone and form a cavity for therapeutic purposes; -
FIG. 2 is an exploded perspective view of the kit shown inFIG. 1 ; -
FIG. 3 is a perspective view of the subcutaneous access instrument group that forms a part of the system shown inFIG. 1 ; -
FIG. 4A is a perspective view of the cavity forming instrument that forms a part of the system shown inFIG. 1 ; -
FIG. 4B is a section view of the catheter tube of the cavity forming instrument, taken generally alongline 4B-4B inFIG. 1 ; -
FIG. 4C is an end view of an alternative embodiment of the cavity forming instrument shown inFIG. 4A , having a prebent stylet; -
FIG. 5 is a perspective view of the material introducing instrument group that forms a part of the system shown inFIG. 1 ; -
FIGS. 6 and 7 are, respectively, top and side views of a human vertebral body; -
FIG. 8 is a top view of a vertebral body during insertion of a spinal needle instrument to begin a bone access procedure; -
FIGS. 9 to 11 are top views showing subsequent steps, after insertion of the spinal needle instrument shown inFIG. 8 , of inserting a guide pin instrument into the vertebral body; -
FIG. 12 is a perspective view showing a subsequent step, after insertion of the guide pin instrument shown inFIGS. 9 to 11 , which deploys an obturator instrument deployed over the guide pin instrument with aid of a handle; -
FIG. 13 is a top view of the vertebral body, with the obturator instrument shown inFIG. 12 deployed; -
FIG. 14 is a perspective view showing a subsequent step, after insertion of the obturator instrument shown inFIG. 12 , which uses the handle shown inFIG. 12 to aid in the deployment of a cannula instrument over the obturator instrument; -
FIG. 15 is a top view of the vertebral body, with the cannula instrument shown inFIG. 14 deployed; -
FIG. 16 is a perspective view showing a subsequent step, after insertion of the cannula instrument shown inFIG. 14 , which removes the obturator instrument from the cannula instrument, to leave the cannula instrument and guide pin instrument in place; -
FIG. 17 is a top view of the vertebral body, after the obturator removal step shown inFIG. 16 , leaving the cannula instrument and guide pin instrument in place; -
FIG. 18 is a perspective view showing a subsequent step, after removal of the obturator instrument shown inFIG. 16 , which uses the handle shown inFIG. 14 to aid in the deployment of a drill bit instrument through the cannula instrument along the guide pin instrument; -
FIG. 19 is a top view of the vertebral body, as the drill bit instrument shown inFIG. 18 is deployed with aid of the handle to open a passage into the interior volume of the vertebral body; -
FIG. 20 is a perspective view showing a subsequent step, after removal of the drill bit instrument and guide pin instrument shown inFIG. 18 , of deploying the cavity forming instrument into the vertebral body; -
FIG. 21 is a top view of the vertebral body, as the expandable structure carried by the cavity forming instrument shown inFIG. 20 is deployed into the interior volume of the vertebral body; -
FIG. 22 is a top view of the vertebral body, as the expandable structure shown in a collapsed condition inFIG. 21 is expanded to compact cancellous bone and form a cavity; -
FIG. 23 is a top view of the vertebral body, after removal of the expandable structure, showing the cavity formed by compacting cancellous bone; -
FIG. 24 is a perspective view of the syringe of the material introducing instrument group, shown inFIG. 5 , being filled with a material selected for introduction into the cavity shown inFIG. 23 ; -
FIG. 25 is a perspective view of the syringe shown inFIG. 24 being joined to a nozzle, which also forms a part of the material introducing instrument group shown inFIG. 5 ; -
FIG. 26 is a perspective view showing the syringe and attached nozzle shown inFIG. 25 being deployed through the cannula instrument in preparation of introducing material into the cavity; -
FIGS. 27 and 28 are perspective and top views, respectively, showing the syringe and attached nozzle shown inFIG. 26 in use to inject material into the cannula instrument for passage into the cavity; -
FIG. 29 is a top view of the vertebral-body after a measured volume of material has been injected and the syringe and attached nozzle withdrawn from the cannula instrument; -
FIG. 30 is a top view showing the deployment of a tamping instrument, which forms a part of the material introducing instrument group shown inFIG. 5 , being deployed in the cannula instrument; -
FIG. 31 is a top view showing advancement of the tamping instrument in the cannula instrument to displace and distribute material from the cannula instrument into the cavity; -
FIG. 32 is a top view of the vertebral body after removal of the tamping instrument and cannula instrument, showing the cavity, now filled with the material; -
FIG. 33 is a perspective view of a reduced diameter cannula instrument and associated reduced diameter material introducing instruments, which embody features of the invention; -
FIG. 34 is a perspective view of a cavity forming instrument having an expandable cavity forming structure, which, in use, is deployed using the reduced diameter cannula instrument shown inFIG. 33 , the cavity forming instrument having a sliding introducer sleeve shown in its rearward position; -
FIG. 35 is a perspective view of the cavity forming instrument shown inFIG. 34 , with the introducer sleeve moved forward to overlie and compress the expandable cavity forming structure; -
FIG. 36 is a perspective view of the cavity forming structure shown inFIG. 35 , with the introducer sleeve (shown partially in section) coupled to the proximal end of the cannula instrument, to guide the expandable structure compressed within the sleeve into the reduced diameter cannula instrument without damage; and; -
FIG. 37 is a perspective view of the cavity forming structure shown inFIG. 36 , after the expandable structure has been guided by the introducer sleeve into the cannula instrument and is being advanced through the cannula instrument for deployment in bone. - 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.
-
FIGS. 1 and 2 show asystem 10 of functional instruments. In use, certain instruments of thesystem 10 are deployed in a purposeful manner to penetrate tissue and gain subcutaneous access to the inside of a bone. Inside bone, other instruments of thesystem 10 are deployed to form a cavity in cancellous bone, into which a material is placed for therapeutic purposes. - In the illustrated embodiment, the
system 10 is arranged as aprepackage kit 12 in threefunctional instrument groups FIG. 3 shows outside the kit 12) comprises instruments whose purpose is to gain subcutaneous access to a bone interior. The second group 16 (whichFIG. 4 shows outside the kit 12) an instrument whose function is to create a cavity in cancellous bone. The third group 18 (whichFIG. 5 shows outside the kit 12) comprises instruments whose function is to introduce a material into the cavity. - The
kit 12 can take various forms. In the illustrated embodiment, thekit 12 comprises a sterile, wrapped assembly. - Further details of each
functional instrument group kit 12 follow. - The number and type of instruments in the
group 14 can vary.FIG. 3 shows five representative instruments, each having a different size and function. - A. The Spinal Needle and Guide Pin
- As
FIG. 3 shows, one instrument comprises a conventionalspinal needle assembly 20 and aguide pin instrument 26. - In use, the
spinal needle assembly 20 establishes the initial subcutaneous path leading to the targeted treatment site. Theguide pin instrument 26 is deployed through this path, followed by progressively larger instruments, as will be described later. - The
spinal needle assembly 20 comprises astylet 22, which is slidably deployed within astylus 24. Thestylus 24 typically has, for example, about an eleven gauge diameter. Other gauge diameters can be used, according to the gauge of theguide pin instrument 26 used. - In use, the
guide pin instrument 26 is deployed through the subcutaneous path established by thespinal needle assembly 20, by exchange with theneedle stylet 22. Theguide pin instrument 26 serves to guide the establishment of the main operative pathway to the targeted treatment site. - The remaining
instruments group 14 share some common features, although they are intended, in use, to perform different functions. Theseinstruments instruments proximal end 34 and adistal end 36. - B. The Obturator Instrument
- The
instrument 28 functions as an obturator. Itsdistal end 36 is tapered to present a penetratingsurface 38. In use, thesurface 38 is intended to penetrate soft tissue in response to pushing or twisting forces applied by the physician at theproximal end 34. - The
proximal end 34 of theobturator instrument 28 presents aflanged surface 40, which tapers from a larger outer diameter to a smaller outer diameter in the direction of theproximal end 34. Theflanged surface 40 includes an array of circumferentially spacedteeth 42. - An
interior lumen 44 extends through theobturator instrument 28 from thedistal end 36 to theproximal end 34. Theinterior lumen 44 is sized to accommodate theguide pin instrument 26, as will be described in greater detail later. - C. The Cannula Instrument
- The
instrument 30 functions as a cannula or guide sheath. Thecannula instrument 30 is somewhat larger in diameter than and not as long as theobturator instrument 28. Thecannula instrument 30 includes aninterior lumen 46 that extends from itsdistal end 36 to itsproximal end 34. Theinterior lumen 46 is sized to accept theobturator instrument 28. The size of theinterior lumen 46 permits a physician to slide and rotate thecannula instrument 30 relative to theobturator instrument 28, and vice versa, as will be described in greater detail later. - The
distal end 36 of thecannula instrument 30 presents anend surface 48. In use, theend surface 48 of thecannula instrument 30 is intended to penetrate soft tissue surrounding theobturator instrument 28 in response to pushing or twisting forces applied at theproximal end 34. - The
proximal end 34 carries anenlarged fitting 50. The fitting 50 tapers from a larger diameter to a smaller diameter in the direction of theproximal end 34. Like the taperedflange 40 on theobturator instrument 28, thetapered fitting 50 has an array of circumferentially spacedteeth 52. Thetapered fitting 50 of thecannula instrument 30 possesses a larger maximum outer diameter than the maximum outer diameter of the taperedflange 40 of theobturator instrument 28. - The
cannula instrument 30 includes measuredmarkings 118 along its length (seeFIG. 3 ). The measuredmarkings 118 gauge the depth of insertion. Themarkings 118 can be placed, for example, at one centimeter intervals. AsFIG. 3 shows, themarkings 118 can be consecutively numbered, beginning at thedistal end 36, so that the physician can ascertain the insertion depth at a glance. - D. The Drill Bit Instrument
- The
instrument 32 functions as a drill bit. Thedrill bit instrument 32 has generally the same physical dimensions as theobturator instrument 28. Like theobturator instrument 28, thedrill bit instrument 32 is intended, in use, to fit for sliding and rotational movement within theinterior lumen 46 of thecannula instrument 30. - The
distal end 36 of the drill bit instrument includes machined cutting edges 54. In use, the cutting edges 54 are intended to penetrate hard tissue in response to rotation and longitudinal load forces applied at theproximal end 34 of thedrill bit instrument 32. - The
proximal end 34 presents a taperedflange 56, which is substantially identical to theflange 40 on theobturator instrument 28. Like theobturator instrument 28, the taperedflange 56 changes from a larger diameter to a smaller diameter in the direction of theproximal end 34. The taperedflange 56 of thedrill bit instrument 32 also includes an array of circumferentially spacedteeth 58. The form and orientation of theteeth 58 on thedrill bit instrument 32 correspond to the form and orientation of theteeth 42 on theobturator instrument 28. - E. The Handle
- The group includes a
handle 60. Thehandle 60 engages thefunctional instruments - The
handle 60 is made from a molded or cast rigid plastic or metal material. Thehandle 60 is shaped to be comfortably and securely grasped by a normal human hand. The shape and size to accommodate this function can, of course, vary. In the illustrated embodiment, thehandle 60 is elongated along a main axis to fit comfortably across the palm of the hand. - The
handle 60 includes acenter post 62, which is integrally molded to thehandle 60 about its geometric center. Thecenter post 62 extends downward to give the handle 60 a general T-shape. - The
handle 60 includes two interior cavities orsockets center post 62. The sockets guide the attachment between thehandle 60 and theinstruments second sockets - The
first socket 64 includes an array of circumferentially spacedgrooves 68, which, in form and orientation, match theteeth obturator instrument 28 and thedrill bit instrument 32. Thefirst socket 64 accepts the taperedflange obturator instrument 28 or thedrill bit instrument 32. Theteeth flange grooves 68 of thefirst socket 64. The running slip-fit allows longitudinal force to be applied to eitherinstrument handle 60. The running slip-fit also prevents relative rotation between eitherinstrument first socket 64, thereby permitting torsional or twisting forces to be applied to eitherinstrument handle 60, with an increased mechanical advantage. - The
second socket 66 is larger than thefirst socket 64 and is sized to accept the larger tapered fitting 50 of thecannula instrument 30. Thesecond socket 66 includes an array of circumferentially spacedgrooves 70, which, in form and orientation, match theteeth 52 on thetapered fitting 50. Theteeth 52 of thetapered fitting 50 mesh in a slip-fit with thegrooves 70 of thesecond socket 66. The running slip-fit allows both longitudinal and torsional forces to be applied to thecannula instrument 30 through thehandle 60, with increased mechanical advantage. - As shown in phantom lines in
FIG. 3 , afirst passage 72 extends through the top of thehandle 60, through thecenter post 62, and into thefirst socket 64. Thepassage 72 is generally aligned with the center of thefirst socket 64 and is sized to pass the guide pin instrument 26 (seeFIG. 12 ). - Likewise, as also shown in phantom lines in
FIG. 3 ) asecond passage 74 extends through the top of thehandle 60, through thecenter post 62, and into thesecond socket 66. Thepassage 74 is generally aligned with the center of thesecond socket 66 and is sized to pass the eitherobturator instrument 28 or the drill bit instrument 32 (seeFIG. 14 ). - Further details of the
handle 60 can be found in co-pending U.S. patent application Ser. No. 09/014,229, filed Jan. 27, 1998, and entitled AA Slip-Fit Handle for Hand-Held Instruments that Access Interior Body Regions. - Further details regarding the use of the
handle 60 and the associatedinstruments - As
FIG. 4A shows; thegroup 16 includes aninstrument 76, which is deployed through thecannula instrument 30 to a location inside bone (seeFIG. 20 ). When so deployed, theinstrument 76 serves to form a cavity in cancellous bone. - The
instrument 76 can be constructed in various ways. In the illustrated embodiment, theinstrument 76 includes aflexible catheter tube 78 having aproximal end 80 and adistal end 82. Theproximal end 80 carries ahandle grip 84 to facilitate gripping and maneuvering thecatheter tube 78. The materials for thecatheter tube 78 are selected to facilitate its advancement through thecannula instrument 30. Thecatheter tube 78 can be constructed, for example, using standard flexible, medical grade plastic materials, like vinyl, nylon, polyethylenes, ionomer, polyurethane, and polyethylene tetraphthalate (PET). Thecatheter tube 78 can also include more rigid materials to impart greater stiffness and thereby aid in its manipulation. More rigid materials that can be used for this purpose include stainless steel, nickel-titanium alloys (NitinolJ material), and other metal alloys. - The
distal end 82 of theinstrument 76 carries anexpandable structure 86. In the illustrated embodiment, theexpandable structure 86 is made from a polyurethane or an elastomer (e.g., silicone or nylon) material. Thestructure 86 has been preformed to possess a desired shape by exposure to heat and pressure, e.g., through the use of conventional thermoforming techniques. - As
FIG. 4B shows, thecatheter body 78 includes aninterior lumen 88, which communicates with the interior of thestructure 86. A fitting 90 on theproximal end 80 of the catheter tube 78 (seeFIG. 48 ) communicates with thelumen 88. The fitting 90 couples thelumen 88 to asource 92 of fluid, sterile saline (seeFIG. 21 ), or a radiopaque contrast medium. - The fluid is introduced from the
source 92 into thestructure 86 under positive pressure, causing thestructure 86 to expand. During expansion inside bone, the material selected for thestructure 86 preferably resists deformation, so that the expanded shape inside bone essentially corresponds to its expanded shape outside bone, i.e., when in an open air environment. This allows the physician to select in an open air environment astructure 86 having an expanded shape desired to meet the targeted therapeutic result, with the confidence that the expanded shape inside bone will be similar in important respects. In addition to being able to expand its volume while resisting deformation inside bone, the material of thestructure 86 preferable withstands abrasion, tearing, and puncture when in contact with cancellous bone. - The shape of the
structure 86, when expanded inside bone, is selected by the physician, taking into account the morphology and geometry of the site to be treated. The shape of the cancellous bone to be compressed, and the local structures that could be harmed if bone were moved inappropriately, are generally understood by medical professionals using textbooks of human skeletal anatomy along with their knowledge of the site and its disease or injury. The physician is also able to select the expanded shape inside bone based upon prior analysis of the morphology of the targeted bone using, for example, plain film x-ray, fluroscopic x-ray, or MRI or CT scanning. The expanded shape inside bone is selected to optimize the formation of a cavity that, e.g., when filled with a suitable material, provides support across the region of the bone being treated. - As one general guideline, in cases where the bone disease causing fracture (or the risk of fracture) is the loss of cancellous bone mass (as in osteoporosis), the selection of the expanded shape of the
structure 86 inside bone should take into account that from 30% to 90% of the cancellous bone volume should be compacted. Another general guideline is the amount that the targeted fractured bone region has been displaced or depressed. The expansion of thestructure 86 within the cancellous bone region inside a bone can elevate or push the fractured cortical wall back to or near its anatomic position occupied before fracture occurred. - In the illustrated embodiment (see
FIG. 4A ), thestructure 86 possesses a preformed hour-glass or peanut shape. This shape is selected in contemplation of deploying thestructure 86 in a vertebral body, as will be described in greater detail later. - To facilitate deployment of the
structure 86 through thecannula instrument 30, thecatheter tube 78 includes a secondinterior lumen 94. Thelumen 94 extends from asecond fitting 98 on theproximal end 80 of thecatheter tube 78, through the body of thecannula tube 78, and through the interior of the thetip end 172 of thestructure 86. Thelumen 94 receives a generallystiff stylet 96, which can be made from a molded plastic or stainless steel material. Thestylet 96 is inserted through the fitting 98 into thelumen 94, and includes a threadedcoupling 100 to secure thestylet 96 against movement. The presence of thestylet 96 serves to keep thestructure 86 in the desired distally straightened condition during passage through thecannula instrument 30 into the targeted tissue region. Once thestructure 86 is free of thecannula instrument 30 and inside bone, thestylet 96 can be withdrawn (shown byarrow 174 inFIG. 4A ). This returns normal flexibility to thecatheter tube 78 and facilitates manipulation of thestructure 86 inside bone. With thestylet 96 withdrawn, thelumen 94 can also serve as a pathway for introducing rinsing liquid or to aspirate debris from the bone. - In the illustrated embodiment, the
stylet 96 is biased toward a generally straight condition. In an alternative embodiment (seeFIG. 4C ), astylet 102 can have a preformed memory, to normally bend its distal region. The memory is overcome to straighten thestylet 102 when confined within thecannula instrument 30. However, as thestructure 86 and distal region of the preformedstylet 102 advance free of thecannula instrument 30, to pass into the targeted region, the preformed memory bends the distal region of thestylet 102 and thereby shifts the main axis of theexpandable structure 86. Theprebent stylet 102, positioned within the interior of thestructure 86, aids in altering the orientation of thestructure 86, bringing it into better anatomic alignment with the targeted region. - Other types of instruments that can form cavities in cancellous bone and other interior body regions are described in co-pending U.S. patent application Ser. No. 09/055,805, entitled AStructures and Methods for Creating Cavities in Interior Body Regions,@ filed Apr. 6, 1998.
- The
group 18 includesinstruments structure 86. The material in the cavity provides a desired therapeutic result, e.g., replacement of tissue mass, or renewed interior support for the bone, or the delivery of medication, or combinations thereof. Accordingly, the material to perform this function can be selected from among, e.g., a material that sets to a hardened condition, including bone cement, autograft tissue, allograft tissue, synthetic bone substitute, as well as a medication, or combinations thereof. - In the illustrated embodiment, the
group 18 comprisesmaterial injection instruments material tamping instrument 108, which deliver material at a low delivery pressure, i.e., a pressure no greater than about 360 psi. - A. Low Pressure Material Injection Instruments
- In the illustrated embodiment, the material is injected by use of a
conventional syringe 104, to which a specially designedinjection nozzle 106 is coupled. A manual actuated syringe with a push plunger can be used. Alternatively, a LeVeen Inflation Syringe with threaded plunger can be used, which can be actuated manually or by use of a mechanical actuator. - In the illustrated embodiment, the
syringe 104 is made from a clear plastic material. Thesyringe 104 includes achamber 110, which receives the material to be injected. The material is expressed from thechamber 100 by a manually advanced syringe piston 112 (see alsoFIG. 25 ). - The
injection nozzle 106 connects by a threadedconnector 114 to the end of the syringe 104 (see alsoFIG. 25 ). In the illustrated embodiment, thenozzle 106 is made from a generally flexible, inert plastic material, such as such as polyethylene or another suitable polymer. Alternatively, thenozzle 106 can be made from a generally rigid plastic or metal material. - The
injection nozzle 106 is sized to be advanced through the cannula instrument 30 (seeFIG. 26 ). Thenozzle 106 includes measuredmarkings 116 along its length. Themarkings 116 can be placed, for example, at one centimeter intervals, to correspond with themarkings 118 on thecannula instrument 30, so that the relative position of thenozzle 106 within thecannula instrument 30 can be gauged. Themarkings 118 can, e.g., include aset point 176. Alignment of theset point 176 at theproximal end 34 of thecannula instrument 30, indicates that the distal end of thenozzle 106 is located in an aligned relationship with thedistal end 36 of thecannula instrument 30. In this arrangement, themarkings 118 are consecutively numbered with positive numbers proximally of theset point 176 and with negative numbers distally of theset point 176. The physician is thereby able to tell at a glance the location of the distal end of thenozzle 106, in terms of how far beyond or short of thedistal end 36 of thecannula instrument 30 it is. - In use, the distal end of the
nozzle 106 is located beyond thedistal end 36 of thecannula instrument 30 within the cavity formed in the targeted tissue region. AsFIG. 5 shows, the distal end of thenozzle 106, when made from a plastic material, can carry at least oneradiopaque marker 208, to enable remote visualization of the nozzle position within the body. Thesyringe 104 elects a predetermined volume of material into thenozzle 106 in a low pressure stream into the cavity. As the material fills the cavity, the nozzle (still ejecting material) is retracted from the cavity and into thecannula instrument 30 itself. Further details of this function and result will be provided later. - B. The Material Tamping Instrument
- The
group 18 also includes amaterial tamping instrument 108. The tampinginstrument 108 is made from generally rigid, inert plastic or metal material. The tampinginstrument 108 is also sized to be advanced into the cannula instrument 30 (seeFIG. 30 ). Thefree end 124 of the tampinginstrument 108 is ribbed or contoured to facilitate gripping theinstrument 108 during use. - The tamping
instrument 108 includes measuredmarkings 122 along its length. Themarkings 116 can be placed, for example, at one centimeter intervals, to correspond with themarkings 118 on thecannula instrument 30, so that the relative position of the tampinginstrument 108 within thecannula instrument 30 can be gauged. Like thenozzle 106, themarkings 122 on the tampinginstrument 108 includes aset point 178, which indicates when the distal end of the tampinginstrument 108 aligns with thedistal end 36 of thecannula instrument 30. Also like thenozzle 106, themarkings 122 on the tampinginstrument 108 are consecutively numbered with positive numbers proximally of theset point 178 and with negative numbers distally of theset point 178. The physician is thereby able to tell at a glance the location of the end of the tampinginstrument 108, in terms of how far beyond or short of thedistal end 36 of thecannula instrument 30 it is. AsFIG. 5 also shows, the end of the tampinginstrument 108, when made from a plastic material, can carry at least oneradiopaque marker 210, so that its position can be visualized from outside the body. - After withdrawal of the
nozzle 106 from thecannula instrument 30, residual material is left in thecannula instrument 30. The purpose of the tampinginstrument 108 is to displace the residual material out thedistal end 36 of thecannula instrument 30 and into the cavity, to thereby fill the cavity without exerting undue pressure within the bone. The tampinginstrument 108 thereby serves to clear residual material from thecannula instrument 30, to assure that the desired volume of material is delivered into the cavity. The removal of residual material from thecannula instrument 30 by the tampinginstrument 108 also prevents seepage of material into surrounding tissue regions upon removal of thecannula instrument 30. The tampinginstrument 108 also compacts the material uniformly within the cavity, again without undue pressure. Further details of these functions and results will be discussed later. - As
FIGS. 1 and 2 show, in the illustrated embodiment, thekit 12 includes aninterior tray 126 made, e.g., from die cut cardboard, plastic sheet, or thermo-formed plastic material. Thetray 126 includes spaced aparttabs 128, which hold the various instruments in a secure position during sterilization and storage prior to use. - When packaged as a sterile assembly, the
kit 12 includes aninner wrap 130, which is peripherally sealed by heat or the like, to enclose thetray 126 from contact with the outside environment. One end of the inner wrap includes a conventional peal-away seal 132, to provide quick access to thetray 126 at the instant of use, which preferably occurs in a sterile environment, such as within an operating room. - When packaged as a sterile assembly, the
kit 12 also includes anouter wrap 134, which is also peripherally sealed by heat or the like, to enclosed theinner wrap 130. One end of the outer wrap includes a conventional peal-away seal 136, to provide access to theinner wrap 130 and its contents. Theouter wrap 134 can be removed from the inner wrap in anticipation of imminent use, without compromising sterility of the contents of thekit 12. - As
FIG. 2 shows, each inner andouter wrap top sheet 138 andbottom sheet 140. In the illustrated embodiment, thetop sheet 138 is made of transparent plastic film, like polyethylene or MYLAR7 material, to allow visual identification of the contents of thekit 12. Thebottom sheet 140 is made from a material that is permeable to ETO sterilization gas, e.g., TYVEK7 plastic material (available from DuPont). - In the illustrated embodiment, the
tray 126 presents theinstruments groups tray 126 can present theinstruments groups stylet 22 andstylus 24 of thespinal needle assembly 20 are deployed first, followed by theguide pin instrument 26, followed by theobturator instrument 28, then thecannula instrument 30, then thedrill bit instrument 32, then thecavity forming instrument 76, then thesyringe 104 andnozzle 106 Instruments, and lastly the tampinginstrument 108. Accordingly, thetray 126 packages these instruments and components in a top-to-bottom order, with thespinal needle assembly 20 topmost, theguide pin instrument 26 next, theobturator instrument 28 next, and so on, with the tampinginstrument 108 lowermost on thetray 126. - In this layout, the
handle 60 is packaged to the side of theaccess instrument group 14. Thetray 126 can include written labels (not shown) identifying the components contained in thekit 12. - The
kit 12 also preferably includes in thetray 126directions 144 for using the contents of the kit to carry out a desired procedure. An exemplary procedure which thedirections 144 can describe will be explained later. - When packaged as a sterile assembly, the
directions 144 can also include the statement “For Single Patient Use Only” (or comparable language) to affirmatively caution against reuse of the contents of thekit 12 whose performance characteristics and efficacy degrade after a single use. Thespinal needle assembly 20, thecavity forming instrument 76, and thematerial introducing instruments directions 144 also preferably affirmatively instruct against resterilization of at least these contents ofkit 12, and also instructs the physician to dispose of at least these contents of thekit 12 upon use in accordance with applicable biological waste procedures. - The presence of the
instrument groups sterile kit 12 verifies to the physician that the contents are sterile and have not been subjected to prior use. The physician is thereby assured that the instrument groups meet established performance and sterility specifications. - It should be appreciated that the various instruments contained in the
kit 12 can be packaged into several, smaller functional kits. For example, a first kit can package theaccess instrument group 14, a second kit can package the cavity forminginstrument group 16, and a third kit can package the materialintroduction instrument group 18,FIGS. 1 and 2 illustrate one of many different possible embodiments. - The following describes use of the
instrument groups kit 12 in the context of treating bones. This is because the instruments of thegroups - In particular, the
instrument groups - A. The Vertebral Body
- As
FIGS. 6 and 7 show, atypical vertebra 146 includes avertebral body 148, which extends on the anterior (i.e., front or chest) side of thevertebra 146. - The
vertebral body 148 has the shape of an oval disk. Thevertebral body 148 includes an exterior formed from compactcortical bone 150. Thecortical bone 150 encloses an interior volume of reticulated cancellous, or spongy, bone 152 (also called medullary bone or trabecular bone). - The
spinal cord 154 passes through thespinal canal 156 of thevertebra 146. The vertebral arch 158 surrounds thespinal canal 156. Thepedicles 160 of the vertebral arch 158 adjoin thevertebral body 148. Thespinous process 162 extends from the posterior of the vertebral arch 158, as do the left and righttransverse processes 164. - B. Treatment of a Vertebral Body
- During a typical 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.
- The physician or surgical assistant removes the outer and
inner wraps kit 12, exposing thetray 126 for use. The physician acquires thespinal needle assembly 20 from thetray 126. AsFIG. 8 shows, the physician introduces thespinal needle assembly 20 into soft tissue ST in the patient's back. Under radiologic or CT monitoring, the physician advances thespinal needle assembly 20 through soft tissue down to and into the targetedvertebra 146. The physician will typically administer a local anesthetic, for example, lidocaine, throughassembly 20. In some cases, the physician may prefer other forms of anesthesia. - The physician directs the
spinal needle assembly 20 to penetrate thecortical bone 150 and thecancellous bone 152 of the targetedvertebral body 148. Preferably the depth of penetration is about 60% to 95% of thevertebral body 148. -
FIG. 8 shows gaining, access to cancellous bone through the side of thevertebral body 148, which is called postero-lateral access. However, access may be indicated through apedicle 160, which is called transpedicular access. The type of access is based upon the objectives of the treatment or for other reasons, based upon the preference of the physician. - As
FIG. 9 shows, after positioning thespinal needle assembly 20 incancellous bone 152, the physician holds thestylus 24 and withdraws thestylet 22. The physician acquires theguide pin instrument 26 from thetray 126. AsFIG. 10 shows, while still holding thestylus 24, the physician slides theguide pin instrument 26 through thestylus 24 and into thecancellous bone 152. The physician now removes the stylus 24 (seeFIG. 11 ), leaving theguide pin instrument 26 deployed within thecancellous bone 152. - The physician next acquires the
obturator instrument 28 and thehandle 60 from thetray 126. The physician slides theobturator instrument 28 over theguide pin instrument 26, distal end first. The physician slides theguide pin instrument 26 through thefirst passage 72 and thefirst socket 64 of thehandle 60. AsFIG. 12 shows, the physician slides thehandle 60 along theguide pin instrument 26 toward the taperedflange 40 of theobturator instrument 28, until achieving a running slip-fit between thefirst socket 64 and the taperedflange 40, in the manner previously described. Theobturator instrument 28 is now ready for use. - As
FIG. 12 shows, the physician makes a small incision I in the patient's back. The physician twists thehandle 60 while applying longitudinal force to thehandle 60. In response, thesurface 38 of theobturator instrument 28 rotates and penetrates soft tissue ST through the incision I. The physician may also gently tap thehandle 60, or otherwise apply appropriate additional longitudinal force to thehandle 60, to advance theobturator instrument 28 through the soft tissue along theguide pin instrument 26 down to the entry site (seeFIG. 13 ). The physician can also tap thehandle 60 with an appropriate striking tool to advance thesurface 30 of theobturator instrument 28 into the side of thevertebral body 148 to secure its position (asFIG. 13 shows). - The physician next slides the
handle 60 along theguide pin instrument 26 away from theobturator instrument 28 to disengage the taperedflange 40 from thefirst socket 64. The physician then proceeds to slide thehandle 60 completely off theguide pin instrument 26. - The physician acquires the
cannula instrument 30 from thetray 126. AsFIG. 14 shows, the physician slides thecannula instrument 30 over theguide pin instrument 26, distal end first, and, further, over theobturator instrument 28, until contact between theend surface 48 and soft tissue ST. The physician now slides theguide pin instrument 26 andobturator instrument 26 through thesecond passage 74 andsecond socket 66 of thehandle 60. The physician slides thehandle 60 toward thetapered fitting 50 of thecannula instrument 30 until a running slip-fit occurs between thesecond socket 66 and thetapered fitting 50, as previously described. Thecannula instrument 30 is now ready for use. - As
FIG. 14 shows, the physician applies appropriate twisting and longitudinal forces to thehandle 60, to rotate and advance thecannula instrument 30 through soft tissue ST along theobturator instrument 28. AsFIG. 15 shows, when theend surface 48 of thecannula instrument 30 contacts cortical bone; the physician can appropriately tap thehandle 60 with a striking tool to advance the end surface into the side of thevertebral body 148 to secure its position. - As
FIG. 16 shows, the physician now withdraws theobturator instrument 28, sliding it off theguide pin instrument 26. This leaves theguide pin instrument 26 and thecannula instrument 30 in place, asFIG. 17 shows. The physician next slides thehandle 60 along theguide pin instrument 26 away from thecannula instrument 30 to disengage the tapered fitting 50 from thesecond socket 66. The physician then slides thehandle 60 completely off theguide pin instrument 26. - The physician now acquires the
drill bit instrument 32 from thetray 126. AsFIG. 18 shows, the physician slides thedrill bit instrument 32 over theguide pin instrument 26, distal end-first, through thecannula instrument 30 until contact between themachined surface 54 and bone tissue occurs. AsFIG. 18 also shows, the physician next leads theguide pin instrument 26 through thefirst passage 72 andfirst socket 64 of thehandle 60. The physician slides thehandle 60 along theguide pin instrument 26 toward the taperedflange 56 of thedrill bit instrument 32, until a running slip-fit occurs between thefirst socket 64 and the taperedflange 56, as previously described. Thedrill bit instrument 32 is now ready for use. - As shown by
FIG. 18 , guided by X-ray (or another external visualizing system), the physician applies appropriate twisting and longitudinal forces to thehandle 60, to rotate and advance thecutting edge 54 of thedrill bit instrument 32 to open a passage 166 (seeFIG. 19 ) through the bone tissue and completely into thecancellous bone 152. The drilledpassage 166 preferable extends no more than 95% across thevertebral body 148. - The physician now slides the
handle 60 along theguide pin instrument 26 away from thedrill bit instrument 32 to disengage the taperedflange 56 from thefirst socket 64. The physician, further, slides thehandle 60 completely off theguide pin instrument 26. - The physician can now remove the
drill bit instrument 32 and theguide pin instrument 26, leaving only thecannula instrument 30 in place. Thepassage 166 made by thedrill bit instrument 32 remains. Subcutaneous access to thecancellous bone 152 has been accomplished. - The physician can now acquire the cavity forming instrument from the
tray 126. AsFIG. 20 shows, the physician can advance theexpandable structure 86 through thecannula instrument 30 andpassage 166 into the interior volume of thevertebral body 148, asFIG. 21 also shows. Thestructure 86 is in its normally collapsed and not expanded condition during deployment. Thestylet lumen 94 of thecatheter tube 78 to provide added stiffness to thestructure 86 while being passed through thecannula instrument 30. - As shown in phantom lines in
FIG. 20 , the physician can, if desired, reconnect thehandle 60 to thecannula instrument 30, to help stabilize thecannula instrument 30 while deploying thestructure 86. Thesecond passage 74 of the handle accommodates thecatheter tube 78 and thestructure 86, when collapsed. - As
FIG. 21 shows, thestructure 86 is oriented in the desired way in thepassage 166. As before explained, thebent stylet 102 can aid in this task. Before, during, or after the orientation process, thestylet FIG. 21 shows), to open thelumen 94 for use to pass a rinsing liquid or negative aspiration pressure. - Sterile liquid is conveyed under pressure from the
source 92 through thelumen 88 into thestructure 86. AsFIG. 22 shows, thestructure 86 expands inside bone. Expansion of thestructure 86 compressescancellous bone 152 in thevertebral body 148. - The compression forms an
interior cavity 168 in thecancellous bone 152. AsFIG. 23 shows, subsequent collapse and removal of thestructure 86 leaves thecavity 168 in a condition to receive a filling material. - The compaction of
cancellous bone 152 can also exert interior force upon cortical bone, making it possible to elevate or push broken and compressed bone back to or near its original prefracture, or other desired, condition. - Upon formation of the
cavity 168, the physician acquires thesyringe 104 andinjection nozzle 106 from thekit 12. AsFIG. 24 shows, the physician fills thesyringe chamber 110 with the desired volume of fillingmaterial 170. AsFIG. 25 shows, the physician attaches thenozzle 106 to the filledsyringe 104. AsFIG. 26 shows, the physician inserts the nozzle 106 a selected distance beyond thedistal end 36 of thecannula instrument 30 and into the cavity, guided by themarkings 116. - As shown in phantom lines in
FIG. 26 , thehandle 60 can remain attached to thecannula instrument 30 to provide stability, as thesecond passage 74 of the handle accommodates thenozzle 106. - As
FIG. 27 shows, the physician manually advances thepiston 112 to cause thematerial 170 to flow through and out of thenozzle 106 and into the cavity. Asmaterial 170 fills the cavity, the physician withdraws the nozzle from the cavity and into thecannula instrument 30. Thecannula instrument 30 channels thematerial 170 flow toward thecavity 168. AsFIG. 28 shows, thecement material 170 flows in a stream into thecavity 168. - If the selected
material 170 is bone cement, thecement material 170 is placed into thesyringe chamber 110 shortly after it is mixed from two materials (e.g., in an external mixing device), while it is in a low viscosity, relatively free flowing liquid state, like a thin pancake batter. In time (e.g., about two minutes after mixing), the consistency of thecement material 170 will change to a substantially putty-like character. - The physician operates the
syringe 104 to expel thecement material 170 from the chamber, through thenozzle 106, first into the cavity and then into thecannula instrument 30. Typically, at the end of the syringe injection process,material 170 should extend from the cavity and, occupy about 40% to 50% of thecannula instrument 30. - When a desired volume of cement is expelled from the
syringe 104, the physician withdraws thenozzle 106 from thecannula instrument 30, asFIG. 29 shows. The physician may first rotate thesyringe 104 andnozzle 106, to break loose the material 170 in thenozzle 106 from the ejected bolus ofmaterial 170 occupying thecannula instrument 30. - The physician acquires the tamping
instrument 108 from thekit 12. AsFIG. 30 shows, the physician advances the tampinginstrument 108 through thecannula instrument 30. As phantom lines inFIG. 30 show, thehandle 60 can remain attached to thecannula instrument 30 to provide stability, as thesecond passage 74 of the handle accommodates the tampinginstrument 108. - The distal end of the tamping
instrument 108 contacts the residual volume ofcement material 170 in thecannula instrument 30. AsFIGS. 30 and 31 show, advancement of the tampinginstrument 108 displaces progressively more of theresidual material 170 from thecannula instrument 30, forcing it into thecavity 168. The flow ofmaterial 170 into thecavity 168, propelled by the advancement of the tampinginstrument 108 in thecannula instrument 30, serves to uniformly distribute and compact thematerial 170 inside thecavity 168, without the application of undue pressure. - The use of the
syringe 104,nozzle 106, and the tampinginstrument 108 allows the physician to exert precise control when filling the cavity withmaterial 170. The physician can immediately adjust the volume and rate of delivery according to the particulcar local physiological conditions encountered. The application of low pressure (i.e., no greater than 360 psi), which is uniformly applied by thesyringe 104 and the tampinginstrument 108, allows the physician to respond to fill volume and flow resistance conditions in a virtually instantaneous fashion. The chance of overfilling and leakage ofmaterial 170 outside the cavity is significantly reduced. - When the physician is satisfied that the
material 170 has been amply distributed inside thecavity 168, the physician withdraws the tampinginstrument 108 from thecannula instrument 30. The physician preferably first twists the tampinginstrument 108 to cleanly break contact with thematerial 170. Thehandle 60 can now be removed and thecannula instrument 30 withdrawn, asFIG. 32 shows. The incision site is sutured closed. The bone treatment procedure is concluded. - Eventually the
material 170, if cement, will harden a rigid state within thecavity 168. The capability of thevertebral body 148 to withstand loads is thereby improved. - The selected
material 170 can be an autograft or allograft bone graft tissue collected in conventional ways. For example, the graft material can be in paste form, as described by Dick, AUse 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; as described by Bhan et al, A ercutaneous Bone Grafting for Nonunion and Delayed Union of Fractures of the Tibial Shaft,@ International Orthopaedics (SICOT) (1993) 17: 310-312, both of which are incorporated herein by reference. 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 30. The tampinginstrument 108 is then advanced into thecannula instrument 30 in the manner previously described, to displace the paste or pellet graft tissue material out of thecannula instrument 30 and into the cavity. - The selected
material 170 can also comprise a granular bone material harvested from coral, e.g., ProOsteonJ calcium carbonate granules, available from Interpore. The granules are loaded into thecannula instrument 30 using a funnel and advanced into the cavity using the tampinginstrument 108. - The selected
material 170 can also comprise demineralized bone matrix suspended in glycerol (e.g., GraftonJ allograft material available from Osteotech), or SRSJ calcium phosphate cement available from Novian. These viscous materials, like the bone cement previously described, can be loaded into thesyringe 104 and injected into the cavity using thenozzle 106, which is inserted through thecannula instrument 30 into the cavity. The tampinginstrument 108 is used to displace residual material from thecannula instrument 30 into the cavity, as before described. - The selected
material 170 can also be in sheet form, e.g. CollagraftJ 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 30. The tampinginstrument 108 is then advanced through the cannula instrument, to push and compact the material in the cavity. - The use of low pressure delivery of
material 170 frees thesystem 10 from the need to accommodate relatively large diameter, high pressure delivery devices. The interior diameter of thecannula instrument 30 can be downsized accordingly, thereby minimizing the dimensions of the subcutaneous pathway to gain access to the targeted bone region. - Typically, when low pressure material injection instruments are used, the largest tool that the reduced-diameter cannula instrument must accommodate is the expandable cavity-forming
structure 82. Thestructure 82 presents a minimal profile during deployment, as it can be collapsed and, if desired, a lubricous coating may also be applied to the exterior of thestructure 82 to facilitate its passage through the reduced-diameter cannula instrument. - A. Low Pressure Material Injection Instruments
-
FIG. 33 exemplifies low pressurematerial injection instruments cannula instrument 184 having a reduced interior diameter, e.g. only about 3.4 mm or less. - One
instrument 180 comprises a reduced-diameter nozzle. AsFIG. 33 shows, thenozzle 180 is sized to pass through the reduced-diameter cannula instrument 184, to thereby pass into bone in the manner previously shown inFIG. 26 . The reduced-diameter nozzle 180 connects by a threadedconnector 186 to thesyringe 104. For material strength, despite its reduced dimension, thenozzle 180 is preferably formed from a rigid metal material, e.g., stainless steel. - As
FIG. 33 shows, the reduced-diameter nozzle 180 also includes measuredmarkings 188 along its length, as previously described. Themarkings 188 include aset point 190, as previously described, which aligns with the proximal end of thecannula instrument 184 when the distal ends of thecannula instrument 184 and thenozzle 180 align. - The other reduced diameter,
instrument 182 comprises a stylet, which is sized to pass through the interior bore of thenozzle 180. Thestylet 182 includes ahandle 192, which rests on theproximal connector 186 of thenozzle 180 when thestylet 182 is fully inserted into thenozzle 180. When thehandle 192 is rested, the distal ends of thestylet 182 andnozzle 180 align. The presence of thestylet 182 inside thenozzle 180 closes the interior nozzle bore. - In use, the
nozzle 180 is coupled to thesyringe 104 and inserted through thecannula instrument 184 into the material-receivingcavity 168 formed in cancellous bone, in the same manner shown inFIG. 26 . Material in thesyringe 104 is injected at low pressure through thenozzle 180 into thecavity 168. As before explained, as thecavity 168 progressively fills with material, thenozzle 180 is withdrawn back into thecannula instrument 184. Typically, when the injection of material is completed, material extends from thecavity 168 and occupies about 40% to 50% of thecannula instrument 184. - At this point, the
nozzle 180 can be fully withdrawn from thecannula instrument 184 and unthreaded from thesyringe 104. Thestylet 182 can be advanced into thenozzle 180, to bring thehandle 192 at rest against theconnector 186, thereby clearing residual material from thenozzle 180. Thenozzle 180 and stylet can then be inserted as a nested unit into thecannula instrument 184. Nested together, thenozzle 180 andstylet 182 form a tamping instrument. Upon advancement through thecannula instrument 184, the nestednozzle 180 andstylet 182 displace residual material from thecannula instrument 184 into thecavity 168, in generally the same manner as previously shown inFIGS. 30 and 31 , thereby uniformly compacting material within thecavity 168 in a controlled fashion and without undue pressure. - Alternatively, a single-piece tamping instrument, separate from the
nozzle 180, can be provided, downsized to fit through the reduced-diameter cannula instrument 184. In this embodiment, thestylet 182 is not necessary, unless it is desired to reclaim material from the nozzle. - B. Cavity Forming Instrument
-
FIG. 34 shows acavity forming instrument 194 intended to be deployed through the reduced-diameter cannula instrument 184, shown inFIG. 33 . In many respects, theinstrument 194 is like theinstrument 76, previously described and shown inFIG. 4A , and common reference numerals will be assigned to common structural elements. Theinstrument 184 includes aflexible catheter tube 78 having aproximal end 80 and adistal end 82. Theproximal end 80 carries ahandle grip 84, and thedistal end 82 carries anexpandable structure 86, which, when deployed in bone, compacts cancellous bone and forms thecavity 168. - Unlike the previously-described
instrument 76, theinstrument 194 carries anintroducer sleeve 196. Theintroducer sleeve 196 slides along thecatheter tube 78 between thehandle grip 84 and theexpandable structure 86. Theintroducer sleeve 196 includes a tubularmain body 198 with aforward collar 200 and arear collar 202. - The
introducer sleeve 196 normally occupies an advanced position on theinstrument 194, as shown inFIG. 35 . In this position, themain body 198 overlies and surrounds theexpandable structure 86. Themain body 198 is sized to compress thestructure 86 to an outside diameter that is slightly less than the interior diameter of the reduced-diameter cannula instrument 184. - As
FIG. 35 shows, when theintroducer sleeve 196 occupies the advanced position, theforward collar 200 extends beyond the distal end of the compressedexpandable structure 82. AsFIG. 36 shows, in this position, theforward collar 200 presents itself for engagement with theproximal end 204 of thecannula instrument 184. Theforward collar 200 is sized to have an interior diameter that makes friction-fit engagement about theproximal end 204 of thecannula instrument 184. - As
FIG. 36 shows, when it is time to deploy theexpandable structure 86 through thecannula instrument 184, the physician engages theforward collar 200 of theintroducer sleeve 196 in a friction fit about theproximal end 204 of thecannula instrument 184. AsFIG. 37 shows, advancing thecatheter tube 78 moves thecompressed structure 86 through themain body 198 of thesleeve 196 and into the bore of thecannula instrument 184. The engagement of theforward collar 200 about theproximal cannula end 204 aligns the axis of thestructure 86 with the axis of thecannula instrument 184, while compressing thestructure 86 to a diameter smaller than the interior of thecannula instrument 184. Upon advancement of thecatheter tube 78, theintroducer sleeve 196 guides thestructure 86 into thecannula instrument 194 without tearing or other damage. - Once the
expandable structure 86 is advanced through thecannula instrument 184 and into bone, the physician can slide theintroducer sleeve 196 rearward away from the proximal cannula,end 204, to break the friction fit between theend 204 and the forward sleeve. AsFIG. 34 shows, therear collar 202 of thesleeve 196 is sized to make a snap fit engagement about astem 206, which surrounds thecatheter tube 78 near thehandle 84. - The snap fit engagement stabilizes the position of the
sleeve 196 during subsequent use and manipulation of the cavity-forminginstrument 194. - The features of the invention are set forth in the following claims.
Claims (11)
- 22. A kit comprising:an access tool sized and configured to provide an access path through soft tissue to bone having an exterior formed, at least in part, by cortical bone, and an interior volume occupied, at least in part, by cancellous bone;an elongate tool sized and configured to fit within the access path, and create a passage in the cancellous bone; anda void forming tool sized and configured to be introduced through the access path and into the passage to form a void in cancellous bone.
- 23. The kit of
claim 22 , wherein the access tool comprises a cannula. - 24. The kit of
claim 22 , wherein the elongate tool comprises an obturator. - 25. The kit of
claim 22 , wherein the elongate tool comprises a drill. - 26. The kit of
claim 22 , wherein the void forming tool is carried by an elongate member sized and configured to pass through the access path. - 27. The kit of
claim 26 , wherein the void forming tool comprises an expandable body. - 28. The kit of
claim 27 , wherein the expandable body, when expanded, assumes a non-spherical shape. - 29. The kit of
claim 27 , wherein the elongate member comprises:a first catheter defining a first lumen for delivering an inflation fluid to the expandable body; anda second catheter positioned at least partially within the first lumen. - 30. The kit of
claim 29 , wherein the expandable body possesses a preformed hour-glass or peanut shape. - 31. The kit of
claim 26 , further comprising an inflation source for delivering inflation fluid to the expandable body. - 32. The kit of
claim 22 , further comprising a nozzle sized and configured to be introduced through the access path and deliver filling material to the void.
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US12/731,571 US20100179556A1 (en) | 1998-08-14 | 2010-03-25 | Methods for placing materials into bone |
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US11/593,284 Expired - Fee Related US7771431B2 (en) | 1998-08-14 | 2006-11-06 | Systems and methods for placing materials into bone |
US11/599,943 Expired - Fee Related US7708742B2 (en) | 1998-08-14 | 2006-11-15 | Methods for placing materials into bone |
US11/599,904 Abandoned US20070093847A1 (en) | 1998-08-14 | 2006-11-15 | Methods for placing materials into bone |
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2001
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2003
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2005
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2006
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2008
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