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WO2010063111A1 - Dispositif et procédé d'ostéotomie intravertébrale percutanée - Google Patents

Dispositif et procédé d'ostéotomie intravertébrale percutanée Download PDF

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Publication number
WO2010063111A1
WO2010063111A1 PCT/CA2009/001756 CA2009001756W WO2010063111A1 WO 2010063111 A1 WO2010063111 A1 WO 2010063111A1 CA 2009001756 W CA2009001756 W CA 2009001756W WO 2010063111 A1 WO2010063111 A1 WO 2010063111A1
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WO
WIPO (PCT)
Prior art keywords
membrane
cannula
vertebral body
cavity
deformable element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/CA2009/001756
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English (en)
Inventor
Peter Jarzem
Juan-Francisco Asenjo
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
McGill University
Royal Institution for the Advancement of Learning
Original Assignee
McGill University
Royal Institution for the Advancement of Learning
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Filing date
Publication date
Application filed by McGill University, Royal Institution for the Advancement of Learning filed Critical McGill University
Publication of WO2010063111A1 publication Critical patent/WO2010063111A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • 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, e.g. 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
    • A61B17/7098—Stabilisers comprising fluid filler in an implant, e.g. balloon; devices for inserting or filling such implants wherein the implant is permeable or has openings, e.g. fenestrated screw
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1613—Component parts
    • A61B17/1615—Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
    • A61B17/1617—Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material with mobile or detachable parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/56—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor
    • A61B17/58—Surgical instruments or methods for treatment of bones or joints; Devices specially adapted therefor for osteosynthesis, e.g. bone plates, screws or setting implements
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/885—Tools for expanding or compacting bones or discs or cavities therein
    • 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
    • A61B17/8855—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 inflatable, e.g. kyphoplasty balloons
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/1642—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for producing a curved bore
    • 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 for implanting artificial joints
    • A61F2/4603—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof
    • A61F2/4611—Special tools for implanting artificial joints for insertion or extraction of endoprosthetic joints or of accessories thereof of spinal prostheses

Definitions

  • the present invention relates generally to orthopedic surgery, and more particularly to a device and method for performing intravertebral osteotomy percutaneously.
  • Vertebroplasty and kyphoplasty are procedures currently performed on patients suffering from vertebral fractures, such as those caused by osteoporosis, cancer and/or trauma. During these procedures, bone cement is injected into the fractured vertebra in order to stabilize the vertebra and reduce pain felt by the patient. Kyphoplasty additionally attempts to restore the normal shape and height of the vertebra through the insertion and inflation of a balloon.
  • Post fracture kyphosis (curvature of the upper spine) affects a significant proportion of the population. While kyphoplasty procedures attempt to restore the original height and angle of kyphosis of a fractured vertebra, some sources have suggested that full vertebral height restoration is only achieved in about 50% of the cases that kyphoplasty is performed.
  • One of the main reasons for this when using standard kyphosis techniques is that the compression fracture sites in the vertebra may have already healed in the deformed state by the time the procedure is conducted. This i occurs mainly because vertebral fractures are often not immediately detected, and by the time they are detected, the fracture sites have re-healed in whole or in part. Further, Kyphoplasty, however, cannot correct all vertebral fractures.
  • osteotomy In order to treat a kyphotic wedged, but healed vertebra, the fracture must first be recreated. This new fracture creation is called an osteotomy. Osteotomies have been used to treat many different types of spine deformities, including excessive kyphosis and even lateral spine tilt. However, current spine osteotomy procedures require an invasive surgery carried out through large incisions, implying significant morbidity and mortality.
  • Cement embolization occurs by a similar mechanism to a cement leak.
  • the cement could be forced into the low resistance venous system and thus could travel to the lungs or brain, resulting in a pulmonary embolism or stroke.
  • metastatic tumors may also lead to defects in vertebra, and these vertebral defects make kyphoplasty and vertebroplasty more difficult because the vertebral defect allows the free flow of cement preferentially away from the vertebra to be treated, and potentially into a dangerous zone.
  • US Patent Application Publication 2007/0067043 Al by Dericks describes a sac to be place in a bone and filled with bone cement. In the preferred embodiment the sac is impermeable to prevent bone cement leakage into the vertebral body.
  • US Patent Application Publication 2007/0233258 Al by Hestad and al. describes a permeable bag. In the preferred embodiments described by Hestad, the bone cement material in inserted under pressure into the permeable bag causing the bag to expand and permeate the bag, such as to enter voids and fissures in the vertebral body simultaneously.
  • International Patent Application WO 2007/067726 A2 by Dutoit et al. describes the insertion of a stent-like device into the fractured vertebral body. In a preferred embodiment described by Dutoit, a folded sheet metal device is said to be inserted into the vertebral body and subsequently expended.
  • the various implants described are open at their respective ends and can be filed with bone cement.
  • a system for percutaneously forming an osteotomy cavity within a vertebral body comprising: a working cannula having a passage extending therethrough from a proximal end thereof adapted to protrude beyond a skin surface to a distal end thereof adapted to be inserted within the vertebral body; and a membrane releasably attached to a distal end of an insertion member received within the cannula such as to direct the membrane to the distal end of the cannula and into the osteotomy cavity formed within the vertebral body, said membrane being at least partially cement-impermeable and displaceable between a contracted first position, wherein the membrane is configured to fit through the passage of the cannula and into the cavity, and an extended second position, wherein the membrane extends to at least partially enclose the osteotomy cavity and to thereby limit egress of bone cement out of the cavity within the vertebral body.
  • a percutaneous method to increase vertebral body height of a damaged vertebra comprising the steps of: cannulating the vertebra with at least one working cannula inserted into the vertebral body; percutaneously cutting a cleavage plane between portions of the vertebral body using a cutting tool inserted through the working cannula, such as to percutaneously create an intravertebral osteotomy; separating the portions of the vertebral body to form an open sided cavity therein, thereby increasing the vertebral body height; inserting a first membrane cannula within the working cannula, said first membrane cannula having a first membrane attached at an extremity of the membrane cannula inserted into the vertebral body, the first membrane being substantially impermeable to a hardening material used to reinforce the vertebral body; positioning the first membrane in a first position within said cavity wherein the membrane partially encloses a first open side of said
  • a percutaneous method to restore vertebral body height by vertebral osteotomy comprising the steps of: cannulating the vertebra with a first and a second working cannula inserted into the vertebral body; percutaneously cutting a cleavage plane in the vertebral body using a cutting tool inserted through at least one of the first and second working cannula; inserting a first deformable element through the first working cannula and a second deformable element in the second working cannula, the deformable elements permitting the perforation thereof in at least one region thereof; placing the first and second deformable elements in respective predetermined orientations; inflating the first and second deformable elements using a filler fluid injected therein to form an open-sided cavity within the vertebral body and thereby restore a height of the vertebral body; removing the filler fluid from the first deformable element, while ensuring that the second deformable element remains in
  • Fig. Ia is a perspective side view of a vertebra in the process of being percutaneously restored to a normal height using the present system following a percutaneous intravertebral osteotomy;
  • Fig. Ib is a frontal view of the vertebra and the present system shown in Fig. Ia;
  • Fig. Ic is a perspective side view of vertebra and system of Fig. Ic, showing the osteotomy cavity being filled with cement after the cement-impermeable membranes of the present system have been positioned in place;
  • Fig. 2 is a partially sectioned side view of the working cannula, the membrane cannula and the balloon cannula which are received within each other as part of the present system;
  • Fig. 3 is a partially sectioned side view of the membrane cannula and the balloon cannula fitted together in a double-cannula package prior to insertion into the working cannula;
  • Fig. 4 is a side view of the working cannula, the membrane cannula and the balloon cannula fitted together, with the balloon of the balloon cannula shown in an inflated position;
  • FIG. 5a-5e show schematic top views of osteotomes of the present system used to perform the percutaneous intravertebral osteotomy
  • Fig. 6 shows a top view of a vertebra in which the osteotomy is percutaneously formed using the osteotomes of the present system
  • FIG. 7 shows a top view of a vertebra in which the intravertebral osteotomy is performed using a motorized cutting tool operated by a robotic system;
  • Figs. 8a is a perspective view of a cement impermeable membrane and associated deployment device
  • Fig. 8b is a top view of the membrane of Fig. 8a;
  • Fig. 8c is a side view of the membrane of Fig. 8a;
  • Fig. 9a is a perspective view of the membrane and deployment device of Fig. 8a, inserted within a working cannula for insertion into a vertebral body;
  • Fig. 9b is a cross-sectional view of the membrane and deployment device within the working cannula, as shown in Fig. 9a;
  • Figs. 9c-9d show the membrane of Figs. 9a-9b being detached from the deployment device by a plunger inserted through the cement delivery tube;
  • Fig. 10 is a side perspective view of an alternate membrane shaped particularly for an anterior defect and having cement windows therein allowing controlled flow of cement therethrough;
  • FIG. 11 is a side perspective view of an alternate membrane shaped particularly for a lateral defect
  • Fig. 12a shows a perspective view of an alternate membrane deploying device, including a ruptureable tubular envelope shown in an enclosed position and within which the membrane is contained;
  • FIG. 12b is a perspective view of the device of Fig. 12b, showing the tubular envelope in a ruptured position exposing the membrane therewithin;
  • Fig. 13a show a cross-sectional view of an alternate lift balloon shown in a compressed position, the lift balloon having side walls which are relatively more rigid that top and bottom walls;
  • Fig. 13b shows a cross-sectional view of the lift balloon of Fig. 13a, shown in an inflated position
  • Fig. 14 is a side view of an alternate lift balloon having an embedded electric device therein for varying the permeability of the balloon;
  • Fig. 15a is a side view of an alternate method of percutaneously restoring a vertebra to a normal height following a percutaneous intravertebral osteotomy, using additional trocars inserted into a vertebra of a lower level;
  • Fig. 15b is a side view of the alternate method and system of Fig. 15a, shown with the working cannulae in the vertebra in which an osteomtomy has been created and the trocars in the adjacent vertebra moved together such as to open the osteotomy.
  • a method and device which enables the repair of vertebral fractures and re-establishment of the natural vertebral body height and kyphosis angle of one or more vertebrae while remaining minimally invasive and limiting the risk of bone cement leakage.
  • Kyphoplasty generally involves performing the following steps: 1) percutaneously cannulating a vertebral body; 2) inserting bone tamps (cavity creating balloons for vertebral bodies); 3) expanding the bone tamps (bone balloons) and thereby 4) restoring some vertebral body height (angulation) or creating a vertebral body cavity; and 5) filling the newly restored body (with a newly created cavity) with acrylic bone cement.
  • the presently disclosed method additionally includes, inter alia, creating an intravertebral osteotomy that is also percutaneously performed and which permits the fractured and/or deformed vertebra to be more fully and consistently repositioned such that the full height thereof is re-established.
  • the osteotomy, or fracture creation, of the vertebra to be restored involves cutting the vertebral body, prior to the addition of any bone cement or a kyphoplasty-type balloon inflation, in order to permit the repositioning of the damaged vertebra into its natural full height location. While osteotomies of have been used to treat spine deformities in the past, they have required making large incisions in the skin and soft tissue, which can cause significant morbidity and potentially mortality.
  • the present device and method allows for such a percutaneously performed intravertebral osteotomy.
  • the present system and method also uses a percutaneously installed cement- impermeable membrane disposed in the osteotomy site within the vertebra in order to retain the injected bone cement within the vertebral body, thereby significantly reducing the likelihood of bone cement leaks.
  • the device 10 is used to perform percutaneous intravertebral osteotomy and vertebral fracture fixation and height restoration without significant risk of bone cement leakage.
  • the device 10 generally includes at least one working cannula 8 and an insertion member that is received within the working cannula and includes a cement- impermeable membrane 16 releasably attached thereto, the insertion member thereby directing the membrane to a distal (inner) end of the working cannula 8 for insertion and deployment of the membrane within the vertebral body cavity.
  • the insertion member may include at least one membrane cannula 12 and/or at least one balloon cannula 13, having a selectively deformable element (such as a balloon 14) fixed thereto, which are sized to concentrically fit within each other such that one or both can be slid within the outer working cannula 8.
  • the balloon cannula 13 is received within the membrane cannula 12, such that the membrane cannula 12 and balloon cannula 13 are thus able to be inserted together and slid within the outer working cannula 12 as one.
  • the system 10 also includes tools for performing the percutaneous intravertebral osteotomy, which will be described in further detail below after the other elements of the system 10 have been first described.
  • the membrane cannula 12 is used to deploy a bone cement impermeable membrane 16 (i.e. a membrane that is substantially impermeable to bone cement) in a given region of the osteotomy site.
  • the bone cement impermeable membrane 16 acts to retain the injected bone cement within the cavity formed in the vertebral body 7 by the osteotomy.
  • the balloon cannula 13 is used to deploy and inflate a lift balloon 14 that acts to separate the cut portions of the vertebral body 7 such as to re-establish the natural height of the vertebra 5, as will be described in further detail below.
  • the outermost working cannula 8 is inserted percutaneously (i.e.
  • the surgeon performing the present technique can readily percutaneously insert a variety of tools, catheters, cannulae and the like, including the membrane and balloon cannulae 12, 13, with accuracy from outside of the patient's body to the exact site selected within the vertebra 5.
  • FIGs. Ia -Ic Two sets of working, membrane and balloon cannulae 8, 12, 13 are shown in Figs. Ia -Ic, as in at least one embodiment of the present system and method, two such sets of cannulae are provided (i.e. one set on each of the medial and lateral sides of the vertebra) for each procedure conducted on the vertebra 5.
  • proximal and distal are intended to refer to positions respectively closer to and further away from the vertebra when the cannulae in question are inserted down into the working cannulae 8 toward the vertebra 5.
  • the membrane cannula 12 includes a membrane element 16 on the proximal end thereof.
  • the membrane 16 may be detachably engaged to the proximal end of the cannula 12 such that, once the membrane has been inserted through the working cannula and into position within the vertebral body cavity, as will be described, it can be detached from the main body of the membrane cannula 12 and left in position. This permits the membrane cannula 12 to be withdrawn if necessary.
  • the membrane 16 is made of a material that is substantially impermeable and/or impervious to the material to be used to fill the cavity formed in the vertebral body, such as bone cement for example. Accordingly, the membrane 16 acts to block or limit the flow of bone cement out of the vertebra.
  • the membrane 16 is thus used in the present procedure to help retain the injected bone cement within the osteotomy cavity 18 formed within the vertebra 5, thereby limiting the risk of bone cement leaking out of the vertebra.
  • an anterior impermeable membrane 16 is placed in position, if there is a posterior defect, the impermeable membrane 16 is posteriorly placed, if there is an equatorial defect you place an equatorial membrane, etc.
  • the impermeable membrane 16 may be disposed at any suitable position such that it covers the areas where a cement leak is to be prevented.
  • the membrane 16 may be positioned about an outer edge of the vertebra 5 and of the cavity 18 formed therewithin, such as to at least partially enclose the cavity 18 by blocking the largest open side of the cavity.
  • the cavity 18 may be formed by first making a lateral cut plane which extends completely through the anterior side of the vertebral body, and then vertically spreading apart the two cut apart end plates of the vertebral body, such as by inflating the lift balloons 14 or by using the trocars and working cannulas as shown in Fig. 15a- 15b.
  • each of the membranes 16 is preferably positioned about one of the sides (i.e. lateral or medial) and at least part of the anterior or front side of the vertebra, as best seen in Fig. Ic which shows two membranes 16 deployed about the anterior periphery of the cavity 18 after the balloons 14 have been inflated. The two membranes 16 thereby enclose a majority of the open outer periphery of the cavity 18.
  • a single cement impermeable membrane 16 sized to be sufficiently large to cover the anterior opening to the osteotomy cavity 18, can be used and positioned as required in order to substantially enclose the cavity formed in the vertebral body by the osteotomy.
  • the osteotomy cavity 18 formed in the vertebral body is then filled bone cement. This is accomplished, as shown in Fig. Ic, using a cement delivery tube 44 that is preferably sized such as to be able to be inserted down through the balloon cannula 13 or the membrane cannula 12, which are themselves disposed within the outer working cannula 8.
  • the cement delivery tube 44 is inserted through the balloon cannula 13, which is left in place within the membrane cannula 12 and therefore without the outer working cannula 8, until an outlet 45 at a proximal end 43 of the cement delivery tube 44 is disposed within the osteotomy cavity 18. Bone cement is then fed through the delivery tube 44 and flows out of the outlet 45 such as to fill the cavity 18.
  • the outlet 45 in the cement delivery tube 44 is located in a side wall of the proximal end 43 such that the cement is ejected out of the tube radially, rather than the tube simply being open at its end, although this of course remains possible also.
  • the proximal end 43 of the tube 44 is provided with two or more openings in the side wall thereof, such as to simultaneously dispense the cement in several directions at once.
  • the tube 44 may include four equally spaced apart openings in the side wall of the tube such that cement is ejected out of the tube into a cross-shaped configuration (i.e. four perpendicular directions at once). This accordingly makes the cement delivery tube 44 a directional injector, such that bone cement can be injected into the cavity 18 in a direction corresponding to the location of the outlet 45.
  • the surgeon needs only to rotate the delivery tube 44 thereby directing a flow of cement in one or more different directions.
  • the cement delivery tube 44 can be either inserted with the balloon 14 in place, such that the balloon 14 is itself filled with bone cement and therefore left in position permanently, or alternately the lift balloon 14 is first deflated and withdrawn (such as by also withdrawing the balloon cannula 13 from the membrane cannula 12) before the cement delivery tube 12 is inserted down into the vertebra for percutaneous injection of the bone cement.
  • the first of these two embodiments i.e.
  • the balloon when the balloon is not removed), the balloon is made of a material which allows for inflation thereof while nonetheless being sufficiently porous such as to allow the bone cement to permeate through walls of the balloon and out into the remainder of the cavity 18.
  • the cement delivery tube 44 is simply inserted directly within the membrane cannula.
  • the second of the two lift balloons i.e. the opposite side from the one being removed
  • the second of the two lift balloons within the vertebra is left in place and is sufficient to hold the spread apart sections of the vertebra in position until such time as the cavity created therebetween can be filled with cement.
  • the lift balloon will break open in a specified direction by any one of a number of mechanisms which maintaining a substantially impermeable area.
  • these mechanism may include providing the balloon with one or more weak seams, or a rip out section or seam, in designated burst regions while still having an impermeable non-burst region which will act as the impermeable membrane even after the other regions burst open.
  • the burst regions will break open when the balloon is filled with cement which still maintaining at least one substantially impermeable area. The open burst areas therefore permit cement flow into the osteotomy cavity.
  • the presence of the cement impermeable membrane 16 about the periphery of the cavity 18 allows it to be subsequently filled with bone cement as described, with little risk of any substantial leakage of the bone cement out of the cavity thus enclosed by the impermeable membrane 16.
  • the position of the membrane 16 may be altered as required in order to best surround and enclose the intravertebral cavity 18 created in the vertebra by the osteotomy, such as to retain the injected bone cement therein.
  • the membrane 16 may be provided with any number of suitable configurations, shapes, sizes, materials, etc. and positioned as required by the surgeon in order to best enclose the osteotomy site formed within the vertebral body.
  • the membrane 16 may be hydrophyllic and is preferably substantially impermeable to the selected bone cement to be used.
  • the membrane 16 may be percutaneously inserted and positioned within the vertebral body in a number of possible manners. For example, these include the embodiments described below, whether by using the inflation of the lift balloon 14 to extend and position the membrane 16 in place, as shown in Figs. 1 and 4, or by deploying the membrane 16 in an alternate manner, such as shown in Figs. 8a - 12b for example. In either case the membrane cannula 12 having the un-deployed membrane 16 on a proximal end thereof is inserted through the outer working cannula 8, before the means for deploying the membrane 16 in place is activated to displace the membrane 16 from its compressed un-deployed shape to its expanded deployed shape.
  • the membrane cannula 12 is itself sized such as to be able to fit within a larger working cannula 8. As noted above, once the working cannulae 8 (two are preferably used) are positioned within the vertebral body 7 being repaired, the other components of the present system can be readily inserted into the exact predetermined position within the vertebral body by simply inserting such components through the working cannulae 8, thereby permitting all of the steps described herein to be performed percutaneously.
  • FIG. 2-4 one embodiment of the present system is depicted in which the membrane cannula 12 and the balloon cannula 13 are inserted together into the working cannula 8, such that the inflation of the balloon 14 of the balloon cannula 13 can be used to deploy the membrane 16 of the membrane cannula
  • the balloon cannula 13 has a selectively deformable element 14 disposed on a proximal end 15 thereof.
  • the membrane cannula 12 has a membrane 16 disposed on a proximal end thereof, the membrane 16 being disposed in an un-deployed configuration such that it can pass through the working cannula 8.
  • the membrane cannula 12 also includes a webbing 17 that surrounds the membrane 16.
  • the webbing 17 acts to position the membrane 16 in place about the balloon 14 when the later is inserted within the membrane and then inflated within the intravertebral cavity.
  • the webbing 17 helps to restrain the membrane 16 in the desired location, such as about the exterior of the vertebral cavity for example, while the balloon 14 of the balloon cannula 14 inflates.
  • the bone cement impermeable membrane 16 is allowed to deploy between the surrounding webbing 17 and the inner inflated balloon 14.
  • the membrane 16 may go from its un- deployed to its deployed position in a variety of manners, whether requiring the balloon to displace it into its deployed position or by having a "shape memory" such that it springs into its extended/deployed position when not restrained.
  • These manners of deployment of the membrane 16 may include, for example, un-rolling, expanding, stretching, springing into a natural position and the like.
  • the membrane 16 is shown in Fig. 4 as extending transversely across the center of the lift balloon 14, it is to be understood that the cement impermeable membrane 16 may surround as much or as little of the lift balloon as required.
  • the membrane 16 may cover an entire half of the lift balloon, whether it being a lower hemisphere, an upper hemisphere, a proximal hemisphere or a distal hemisphere for example.
  • the selectively deformable element 14 of the balloon cannula 13 is an inflatable "lift" balloon, however it is to be understood that other alternatives are possible. Regardless, however, the selectively deformable element, or lift balloon, 14 is displaceable between a relaxed, or deflated, configuration as seen in Figs. 2-3 and an enlarged, or inflated, configuration as seen in Fig. 4. In the relaxed configuration, the lift balloon 14 is configured to fit, such as by being compressed, folded, etc. within the inner diameter of the membrane cannula 12, such as to form the combined double-cannula package 11 as seen in Fig. 3.
  • the combined package of the membrane cannula 12 having the relaxed selectively deformed element 14 thereon and the balloon cannula 13 therewithin, as seen in Fig. 3, is fed down the length of the working cannula 8.
  • the relaxed lift balloon 14 is inserted within a cut formed in the vertebra body by an osteotomy, as will be described in further detail below.
  • the selectively deformable element 14 is displaced into its enlarged position, as shown in isolation in Fig. 4, such as by inflating the lift balloon 16.
  • the vertebral body is spread apart and the osteotomy cut therein is enlarged such as to define a cavity 18 within the vertebral body 7.
  • the balloon which comprises the selectively deformable element 14, is controlled such as by introducing more or less fluid (such as, but not limited to, air) therein, such as to lift or spread apart the two portions of the vertebral body 7 disposed on opposite sides thereof and thereby expand the cavity 18 within the vertebral body a desired amount.
  • This acts to lift a superior end place of the vertebral body 7 a height necessary to reestablish the natural height of the vertebra 5.
  • the present method involves the percutaneously performed step of creating an intravertebral osteotomy. This is done after the cannulation of the vertebral body, i.e. after the working cannulae 8 have been installed in place, but prior to the insertion of the membrane and balloon cannulae 12, 13.
  • a number of different configurations of cutting elements may be used, such as osteotomes (i.e. a tool used to cut the bone element), in order to be able to perform the osteotomy of the vertebra through the working cannulae 8, that is, percutaneously.
  • Osteotomes of various geometries which can be inserted through the working cannulae 8, can be used such as to create a cleavage plane within the vertebral body 7, such that when the lift balloon(s) 14 are inserted in this cleavage plane and inflated, the cavity 18 within the vertebra is formed thereby re-establishing the full height of the vertebra.
  • Figs. 5a and 5b respectively show a straight segmented or hinged osteotome 30 and a straight multi-segmented or double-hinged osteotome 32, both of which are configured to be able to inserted through the working cannulae 8 in order to allow for percutaneous access to the site in the vertebral body that is to be cut.
  • the hinged cutting tip 31 of the osteotomes 30, 32 allows for the osteotomy site 36 to be cut out within the vertebral body 7 of the vertebra 5, as seen in Fig. 6, while nonetheless still being able to be inserted down through the tubular working cannula 8 (when the tip is straightened out) in order for the cutting tip 31 to accurately access the selected intravertebral osteotomy site 36.
  • Figs. 5c and 5d show two other possible osteotome configurations, namely curved osteotomes 34 and 35.
  • Fig. 5e shows a detailed view of the pivoting cutting tip 31 of the multi-segmented osteotome 32, which is controlled via guide cables 37 which run through the interior of the hollow osteotome 32 and are fixed at two laterally spaced apart anchor points 39 on the tip 31. As such, by pulling on one or the other of the two guide cables 37, the pivoting tip 31 will swing back and forth, thereby permitting a cutting plane within the bone to be created.
  • the curved osteotome 34 may also include a segmented tip 31 that pivots/hinges relative to the main curved body 33 of the osteotome.
  • Both of the curved osteotomes 34, 35 are nonetheless receivable within the working cannulae 8, whether by being flexible or simply configured (such as, for example, by having a large-enough radius curve or a sufficiently small cross-section) such as to permit being slid through a straight working cannula 8.
  • the working cannulae 8 may be themselves provided with a curved configuration such as to allow for a similarly curved osteotome to be received therethrough.
  • the cutting element used includes motorized cutting tools, whether operated by the surgeon and/or by an automated robotic system, can similarly be employed in order to form the cut through the vertebral body, thereby permitting the re-establishment of the height of the vertebra using the lift balloons 16 as described above.
  • a motorized cutting tool 40 is sized and configured to fit within the working cannula 8, such that the motorized cutting tool 40 can be inserted down through the working cannula 8 and into the vertebral body in order to percutaneously form the intravertebral osteotomy (i.e.
  • the motorized cutting tool 40 may be a rotating cutting bit, such as a milling tool, including a high-speed burr for example.
  • the milling tool 40 is, in one embodiment, operated by a robotic system 42, such as a 5-axis numerically- controlled robotic system for example.
  • the robotic system may be fully automated, manually controlled by the surgeon or a combination thereof. The surgeon may for example configure the robotic system to displace the milling tool 40 along a predetermined path in space, wherein the milling tool 40 is inserted through the working cannula 8 to a given depth and activated (i.e.
  • the robotic system 42 which operates the milling tool 40 in conjunction with the surgeon may also be provided with the necessary sensors and control mechanisms to allow the rotating milling tool 40 to cut only through bone material, in order to avoid nerves, blood vessels, etc. which surround the bone of the vertebrae and which are not to be damaged. This may also be done in conjunction with appropriate image guided devices.
  • the robots may serve to actively cut the vertebrae, or may be used passively only to limit the area cut while the surgeon is moving the cutting tool himself.
  • milling tool 40 and robotic system 42 are described above, it is to be understood that a variety of other motorized, or non motorized, automated and/or robotically controlled cutting tools can be used to carry out the percutaneously osteotomy of the vertebrae as described herein.
  • Figs. 8a- 12b alternate bone cement impermeable membranes and means for deploying them will now be described.
  • the membrane 116 is deployed instead by another tube or cannula, acting as the insertion member, that is inserted through the working cannula 8, such as the cement delivery tube 44.
  • the membranes in these embodiments all preferably are elastically deflectable such that they can be rolled or folded up for insertion through the working cannula 8 but nevertheless spring out to their deployed position and shape when released within the cavity such as to provide a stiff yet flexible barrier or "fence".
  • the membranes used within the present embodiments may be made of any number of cement impermeable elastically deformable and/or shape-memory materials, such as a thin nitinol shape memory allow, a plastic or a thin biocompatible metal for example.
  • a membrane 116 is removably mounted to the proximal end 143 of the cement delivery tube 144 (itself disposed within the outer working cannula 8), such that the cement delivery tube 144 is also used to insert and deploy the membrane 1 16 within the cavity of the vertebra, prior to the injection of bone cement in the cavity via the same tube 144.
  • the membrane 116 When disposed in its fully-extended or deployed position, the membrane 116 is as shown in Figs. 8a-8c.
  • the membrane 116 forms a generally L-shaped configuration when disposed in the fully-extended or deployed position, thereby permitting it to at least partially enclose two sides of the cavity formed in the vertebral body.
  • the membrane In order to be inserted down through the working cannula 8 before being deployed within the intravertebral cavity, the membrane must still be able to be rolled- up or otherwise compressed (i.e. disposed in an un-deployed or delivery configuration) such as to fit within the working cannula 8. Therefore, the flexible membrane 116 removably attached to the end of the bone cement delivery tube 144 is first rolled up and inserted within the outer working cannula 8, and the cement delivery tube is inserted down through the working cannula as shown in Figs. 9a-9b. Once the membrane 116 is no longer confined within the working cannula 8, that is once it reaches the cavity in the vertebral, the membrane will spring freely out into its fully extended deployed position as shown in Fig.
  • the membrane 1 16 is preferably, but not necessarily, detached from the proximal end 143 of the cement delivery tube 144.
  • the cement delivery tube 144 is then already in place to being the injection of the bone cement into the vertebral cavity.
  • one or more severable fasteners in the form of plastic rivets 146 are used to releasably fasten the membrane to the cement delivery tube.
  • These rivets 146 are configured to fasten the membrane 116 to the delivery tube 144 until such time as they are severed or otherwise broken to disconnect the two components from each other. For example, this can be accomplished by using a plunger 148 which is inserted in a proximal direction 147 down through the cement delivery tube 144 and is used to forcibly contact the rivets 146, which project out into the internal space within the hollow delivery tube 144, thereby snapping off the rivets 146 and thus releasing the membrane 116.
  • Other release mechanisms are of course also possible, and may even simply include the manual manipulation of the tube by the surgeon such as to break the rivets 146, which can be pre-weakened as required, thereby releasing the membrane 116 from the delivery tube 144.
  • Figs. 10 and 11 depict alternately shaped membranes 216 and 316 respectively, which are similar to the membrane 116, however the membranes 216 and 316 are configured/shaped specifically for enclosing the osteotomy cavities formed in vertebrae having anterior and lateral defects respectively. While other shapes and configurations are possible, these membranes include, for example, an enlarged barrier portion at a point thereon which is to be aligned with a targeted defect or other larger gap in the cavity. The enlarged barrier portion having a surface area that is greater than the central body portion of the membrane.
  • the membrane 216 has an enlarged remote end region 217, adapted to cover the anterior vertebral defect and located on the end of the membrane opposite that removably fastened to the cement delivery tube, which is shaped to enclose the larger anterior cavity opening.
  • the membrane 216 also includes an additional feature, namely at least one cement window 218 through which a small and controlled amount of bone cement is allowed to flow.
  • the membrane 316 is shaped for best use in lateral defect vertebra, and includes an enlarged central region 317 adapted to cover the lateral vertebral defect and a thinner stability tail 318 which helps to anchor the membrane in place.
  • the cement impermeable membrane 416 is made up of a central flexible metal "backbone” 417 that is elastically deformable yet rigid and which is incorporated within a larger flexible tubular envelope 418.
  • This composite membrane structure acts like a "bursting sausage", wherein the tubular envelope 418 is fully enclosed (i.e. has a closed end) as shown in Fig. 12a, such that when it is filled with bone cement via the cement delivery tube 448, the tubular envelope 418 will fill up until the pressure therein is sufficiently high to cause the flexible tubular envelope to burst.
  • the flexible envelope may be made of a plastic or other suitable material, and may further be scored along a breach line 419, such that the plastic tubular envelope will be more likely to break or burst along this line when the pressure of the bone cement injected therein rises. This permits both a controlled burst and a predetermined amount of pressure to be established at which the tube is to break, thereby deploying the entire membrane structure 416 early enough for it to assume the desired position in order to close off the osteotomy cavity while nonetheless being actuated by the initiation of the bone cement injection.
  • the surgeon will insert the disclosed device 10 in a percutaneous access consisting of working cannula extending through the pedicles of vertebral bodies. Osteotomes of various geometries may be inserted through the working cannulae and into the vertebrae, so as to create the cleavage plane within the vertebral body.
  • the lift balloons 14 are then inserted between the vertebra adjacent the fractured site.
  • the balloons 14 are inflated to expand the fractured vertebra 16.
  • the balloons 14 are then inflated simultaneously to open the osteotomy.
  • the membranes 16 are then placed in the first position partially enclosing the cavity. Guide threads or webbing 17 are used to maintain the membrane 16 in place over the balloon 14.
  • the second balloon 14 is then removed and the cavity 18 left behind is then also filled with cement. Once the bone cement has cured, the osteotomies are secure, and the working cannula can then be removed, and the stab wounds can be closed.
  • the membranes and osteotomy cavities are filled with in-situ curing PMMA.
  • Bioactive "cements” such as calcium phosphate, hydroxyapatite, carbonated apatite cement, and glass-ceramic powders could be used rather than PMMA.
  • Other bio-compatible in-situ curing materials may be used such as polyurethane, hydrogel, or bioactive glues. Resorbable cements of any type can also be used,
  • the balloons 114 may be formed with rigid side walls 115 (i.e. more rigid than the upper and lower walls 116 of the balloon), thereby substantially limiting the balloon deployment to the vertical direction (such as when performing an osteotomy expansion) by substantially limiting expansion in the lateral directions as a result of the more rigid lateral side walls of the balloon.
  • rigid side walls 115 i.e. more rigid than the upper and lower walls 116 of the balloon
  • the more flexible top and bottom walls 1 16 thereof are compressed, which the side walls 1 15 substantially retain their shape given their more rigid structure.
  • the more flexible top and bottom walls 1 16 expand upwards and downwards, which the more rigid side walls 115 maintain their shape and limit lateral expansion of the balloon.
  • a balloon which is confieured such as to have one or more different wall portions that is more rigid that the remaining walls, such as to control, as desired, the inflation of the balloon.
  • the membrane 16 once deployed in the desired position corresponding to the extended position, will substantially block the lateral egress of the cement.
  • the membrane is impermeable to cement and may be made of thin nitinol shape memory alloy, plastic or thin biocompatible metal for example.
  • the membrane 16 can be initially attached to one end of the device 10 by means such as rivets which can be used to retain the membrane in place until the cement is injected. Following the injection of the cement, the rivets are removed before the cement is hardened.
  • Other means of attaching the membrane 16 to the device known in the art can also be used. Such means can include breakable joints for example.
  • the device 10 may be made from a material that expands.
  • the device could be made of bio-resorbable materials including polylactic acid (PLA), polyglycolic acid (PGA), poly (ortho esters), poly (glycolide-co-trimethylene carbonate), poly-L-lactide- co-6-caprolactone, polyanhydrides, poly-n-dioxanone, and poly (PHB-hydroxyvaleric acid). It may also be constructed to allow more expansion of the device in a cranial to caudal direction than in a radial direction.
  • the device may also be made of elastic or inelastic materials.
  • the device is may, in one particular embodiment, be made of polymers.
  • the disclosed methodology requires the creation of an osteotomy that will permit fractured vertebrae to have a correction of their deformity. Blood loss would be minimal.
  • the disclosed methodology is also an advance over conventional open surgical techniques that require major surgical incisions, large amounts of muscle dissection, major blood loss and is associated with high mortality and morbidity.
  • the advantage of the use of the disclosed device is that it would permit correction of all (100%) vertebral fractures and not just 50% of the fractures as has been demonstrated for kyphoplasty. Even healed fractures could be treated. In addition, lateral deviations of the spine could be treated, particularly those due to fracture. Metastatic tumors not previously amenable to kyphoplasty or vertebroplasty would now be amenable to percutaneous treatment. Scoliotic deformities could also be treated with this the present device in a oercutaneous fashion. [0080] The present device and methodology permit correction of both kyphotic and scoliotic deformities through minimally invasive, percutaneous techniques.
  • a percutaneously performed method of restoring vertebral body height by vertebral osteotomy includes the steps of: cannulating the vertebra with at least one working cannula inserted into the vertebral body; percutaneously cutting a cleavage plane in the vertebral body, using a cutting tool inserted through the working cannula; inserting a membrane cannula, having a selectively deformable element attached at an extremity thereof, into the working cannula, the selectively deformable element including a cement-impermeable membrane releasably attached thereto; inflating the selectively deformable element to expand the vertebral body thereby restoring a height of the vertebral body and forming an open-sided cavity therein; placing the cement-impermeable membrane in a position such that it at least partially encloses the cavity; and injecting cement through the working cannula into the cavity in the vertebral body.
  • a lift balloon 214 is used that is selectively permeable, in that the permeability of the balloon changes and can be controlled as desired. This is accomplished by making the balloon out of a material whose permeability varies in response to either a direct electric current or temperature.
  • the balloon 214 may include an electric element 220 that is embedded therein and which is electrically connected to a power source such as to provide a selectively controlled electric current flow through the electric element 220 in the balloon wall.
  • the electric element 220 may act as a heating element which increases the local temperature of the balloon 214 when the heating element is fed with current, thereby, for example, increasing the permeability of the balloon in these higher temperature areas.
  • the material of the balloon 214 may be such that when exposed to a current flow through the electric element 220, whether or not any temperature change occurs, the permeability of the balloon surrounding the electric element is varied as desired such as to increase or decrease the local permeability thereof.
  • the permeability of the balloon is varied as desired by controlling the amount of electric current flowing through the electric element 220 embedded therein.
  • FIGs. 15a- 15b an alternate embodiment is depicted in which one or more additional trocars 208 are used to open up the osteotomy site, either in lieu of or in addition to the lift balloons described above, such as to create the cavity 18 within the vertebral body.
  • Trocars 208 may be inserted, percutaneously, into either the vertebra 5 in which the osteotomy has been created, for example above or below the osteotomy site, or alternately into an adjacent vertebra 6.
  • a movement of the exposed ends of the trocars 208 towards the exposed ends of the working cannulae 8 in opposed directions 210 will cause the lateral cut plane of the osteotomy within the vertebra 5 to move away from each other thereby forming the cavity 18 therebetween, as shown in Fig. 15b. Accordingly, angulation of the trocars 208 relative to the working cannulae 8 will allow the osteotomy to open up, thereby substantially restoring the original height and/or shape of the vertebra.
  • the membranes 16 may then be positioned within this vertebral cavity 18 in a manner to best enclose the open side(s) of the cavity for retention of the bone cement to be injected therein.
  • trocars 208 may be used without the lift balloons to open up the osteotomy cut within the vertebra
  • balloons can also be used in conjunction with the trocars 208, for example to maintain a portion of the vertebra in the opened position until such time as the cavity formed thereby can be filled with cement.
  • the trocars 208 and the cannulae 8 may also be identical, and can include a slot at an inner end thereof for deployment of the balloons therefrom.

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Abstract

L'invention porte sur un dispositif (10) d'exécution percutanée d'une cavité d'ostéotomie (18) à l'intérieur d'un corps vertébral (7), lequel comprend une canule de travail (8) comportant un passage s'étendant dans celui-ci d'une extrémité proximale à une extrémité distale de celui-ci, et une membrane (16) fixée de manière libérable à l'extrémité distale d'un élément d'insertion (12, 144) placé à l'intérieur de la canule de façon à orienter la membrane vers l'extrémité distale de la canule et à l'intérieur de la cavité d'ostéotomie ménagée à l'intérieur du corps vertébral. La membrane est au moins partiellement imperméable au ciment et déplaçable entre une position contractée, dans laquelle la membrane est configurée pour s'adapter au passage dans la canule (8) et dans la cavité (18), et une position déployée, dans laquelle la membrane (16) s'étend pour enfermer au moins partiellement la cavité d'ostéotomie (8) et pour ainsi limiter une sortie du ciment osseux hors de la cavité (18) à l'intérieur du corps vertébral (7).
PCT/CA2009/001756 2008-12-03 2009-12-03 Dispositif et procédé d'ostéotomie intravertébrale percutanée Ceased WO2010063111A1 (fr)

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EP2422726A1 (fr) * 2010-08-23 2012-02-29 Korsakov, Konstantin Vladimirovich Dispositifs de cyphoplastie vertébrale à ballonnet
US8795369B1 (en) 2010-07-16 2014-08-05 Nuvasive, Inc. Fracture reduction device and methods
US10064735B1 (en) 2017-07-06 2018-09-04 Robert E Simonson Method of inserting a surgical implant within a transcorporeal void
US11129727B2 (en) 2019-03-29 2021-09-28 Medos International Sari Inflatable non-distracting intervertebral implants and related methods
CN113813088A (zh) * 2021-08-11 2021-12-21 宁波华科润生物科技有限公司 一种脊柱全内镜下环形椎间融合系统
US11766338B1 (en) 2023-02-06 2023-09-26 Robert E. Simonson Method and apparatus for placement of a reduced vertebral body replacement device during a surgical operation on the cervical portion of the spine including into a transcorporeal void
US11857431B1 (en) 2023-02-01 2024-01-02 Robert E. Simonson Method and apparatus for placement of vertebral body replacement device into a transcorporeal void during a surgical operation on the cervical portion of the spine
US12232971B1 (en) 2024-08-06 2025-02-25 Robert E. Simonson Method and apparatus for directional guidance in the performance of a partial vertebrectomy within a cervical spine

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US20040073308A1 (en) * 2000-07-21 2004-04-15 Spineology, Inc. Expandable porous mesh bag device and methods of use for reduction, filling, fixation, and supporting of bone
US20040215344A1 (en) * 2000-02-28 2004-10-28 Stephen Hochschuler Method and apparatus for treating a vertebral body
WO2007067726A2 (fr) * 2005-12-08 2007-06-14 Synthes (U.S.A.) Appareil et méthodes pour traiter un tissu osseux

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US20040215344A1 (en) * 2000-02-28 2004-10-28 Stephen Hochschuler Method and apparatus for treating a vertebral body
US20040073308A1 (en) * 2000-07-21 2004-04-15 Spineology, Inc. Expandable porous mesh bag device and methods of use for reduction, filling, fixation, and supporting of bone
US20030088249A1 (en) * 2001-11-03 2003-05-08 Sebastian Furderer Device for straightening and stabilizing the vertebral column
WO2007067726A2 (fr) * 2005-12-08 2007-06-14 Synthes (U.S.A.) Appareil et méthodes pour traiter un tissu osseux

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8795369B1 (en) 2010-07-16 2014-08-05 Nuvasive, Inc. Fracture reduction device and methods
US9144501B1 (en) 2010-07-16 2015-09-29 Nuvasive, Inc. Fracture reduction device and methods
EP2422726A1 (fr) * 2010-08-23 2012-02-29 Korsakov, Konstantin Vladimirovich Dispositifs de cyphoplastie vertébrale à ballonnet
US10064735B1 (en) 2017-07-06 2018-09-04 Robert E Simonson Method of inserting a surgical implant within a transcorporeal void
US11129727B2 (en) 2019-03-29 2021-09-28 Medos International Sari Inflatable non-distracting intervertebral implants and related methods
CN113813088A (zh) * 2021-08-11 2021-12-21 宁波华科润生物科技有限公司 一种脊柱全内镜下环形椎间融合系统
US11857431B1 (en) 2023-02-01 2024-01-02 Robert E. Simonson Method and apparatus for placement of vertebral body replacement device into a transcorporeal void during a surgical operation on the cervical portion of the spine
US12324743B1 (en) 2023-02-01 2025-06-10 Robert E. Simonson Method and apparatus for placement of a vertebral body replacement device into a transcorporeal void during a surgical operation on the cervical portion of the spine
US11766338B1 (en) 2023-02-06 2023-09-26 Robert E. Simonson Method and apparatus for placement of a reduced vertebral body replacement device during a surgical operation on the cervical portion of the spine including into a transcorporeal void
US11925564B1 (en) 2023-02-06 2024-03-12 Robert E. Simonson Method and apparatus for placement of a reduced vertebral body replacement device during a surgical operation on the cervical portion of the spine including into a transcorporeal void
US12239543B1 (en) 2023-02-06 2025-03-04 Robert E. Simonson Method and apparatus for placement of a reduced vertebral body replacement device during a surgical operation on the cervical portion of the spine including into a transcorporeal void
US12232971B1 (en) 2024-08-06 2025-02-25 Robert E. Simonson Method and apparatus for directional guidance in the performance of a partial vertebrectomy within a cervical spine

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