WO2010100287A1 - Barrière pour implantation dans un os, en particulier pour la vertébroplastie - Google Patents

Barrière pour implantation dans un os, en particulier pour la vertébroplastie Download PDF

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Publication number
WO2010100287A1
WO2010100287A1 PCT/EP2010/052927 EP2010052927W WO2010100287A1 WO 2010100287 A1 WO2010100287 A1 WO 2010100287A1 EP 2010052927 W EP2010052927 W EP 2010052927W WO 2010100287 A1 WO2010100287 A1 WO 2010100287A1
Authority
WO
WIPO (PCT)
Prior art keywords
barrier
bag
filling hole
closure
filler medium
Prior art date
Application number
PCT/EP2010/052927
Other languages
English (en)
Inventor
Danica Cervincova
Andreas Reindl
Mark Taylor
Jochen Borris
Michael Thomas
Frank Kniep
Dirk Hornscheidt
Thammo Weise
Original Assignee
Somatex Medical Technologies Gmbh
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Priority claimed from DE102009011561A external-priority patent/DE102009011561A1/de
Priority claimed from DE102009011566A external-priority patent/DE102009011566A1/de
Application filed by Somatex Medical Technologies Gmbh filed Critical Somatex Medical Technologies Gmbh
Publication of WO2010100287A1 publication Critical patent/WO2010100287A1/fr

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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, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, 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
    • A61B17/8811—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the introducer tip, i.e. the part inserted into or onto the bone
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • 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, setting implements or the like
    • 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
    • A61B17/8858—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 laterally or radially expansible
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00004—(bio)absorbable, (bio)resorbable, resorptive

Definitions

  • the invention relates to a barrier for implantation into bone, in particular for vertebroplasty, the barrier having a bag and at least one filling hole to which a feeding device for feeding a filler medium is attachable.
  • a barrier for receiving bone cement used in percutaneous kyphoplasty operations is known from US 2006/0217736 A1.
  • This barrier is made of a resorbable material and has a filling hole on which a feeding device is provided. Once this barrier has been inserted into a cavity within a vertebral body that is to be filled, the barrier is filled with bone cement via the feeding device. The collapsed barrier expands until the cavity in the vertebral body is completely filled with bone cement. Subsequently, the feeding device is removed from the barrier bag.
  • This arrangement has the disadvantage that bone cement may escape again from the barrier if the feeding device is separated from the barrier at a time when the bone cement has not yet cured. Waiting for the bone cement to cure would prolong the duration of the surgical operation and lead to an undefined point of separation between the barrier and the feeding device, on account of the partially cured bone ce- ment.
  • a barrier made of a resorbable material which is closed after filling with a bone cement within the vertebral body is known from WO 2006/112941 A1.
  • the closing of the barrier is proposed to be realised by means of heat or via a bonding agent.
  • this development of the barrier has the advantage that the filling hole is suggested to be closed at an early stage, when the bone cement has not yet completely cured, this configuration has, on the other hand, the disadvantage that the creation of such a closure is time-consuming and that, moreover, the introduction of heat or additional bonding material represents a further disadvantage.
  • bone cement may escape until the closure of the filling hole is completed.
  • an objective of the invention to create a barrier for implantation into bone, in particular for vertebroplasty, which prevents filler medium from escaping during and after the filling operation, so that the barrier is realised in a leakage-free manner.
  • the configuration of a barrier according to the present invention which has a closure apparatus that automatically closes or clogs during a transient interruption of the filling operation and/or subsequent to a completion of the filling operation with filler medium, in particular bone cement, has the advantage of permitting the realisation of a leakage-free arrangement. Thus, leakage of the filler medium, in particular bone cement, during or after the filling operation is prevented.
  • the configuration of the barrier according to the invention with an automatically closing or clogging closure apparatus permits the utilisation of both low-viscosity and high-viscosity media as well as both slowly curing and rapidly curing bone cements.
  • the automatically closing closure apparatus may in addition reduce the duration of a surgical operation, as the feeding device for feeding the filler medium may be removed immediately after completion of the filling of the barrier with the filler medium.
  • an inward-turned portion is designed to be provided on the filling hole of the barrier, said inward-turned portion extend- ing at least partially into the interior of the bag and the passageway thereof being capable of closing after completion of the filling operation with the filler medium. Due to this arrangement of an inward-turned portion within the bag, it is possible for the passageway of the inward-turned portion to become progressively constricted, as the fill level of the filler medium increases. The filler medium progressively presses against the inward-turned portion and closes it as the filling operation is being completed. This has the advantage that after detaching or disengaging of the feeding device from the barrier, a leakage-free closure is created.
  • the inward-turned portion provided in the interior of the bag preferably has an outlet that is beak-shaped or slot-shaped when in an inactive position. This may ensure, on the one hand, an easy inflow of the filler medium into the bag, while enabling, on the other hand, an automatic closing of the outlet due to the beak-shaped or slot-shaped configuration thereof, since the end portions of the outlet are in tight contact with each other.
  • the configuration of the inward-turned portion is preferably designed to be disposed immediately adjacent to the filling hole, which has a round or a conical cross- section or any other cross-section suitable for receiving a feeding device and which turns into a slot-shaped outlet, a cross-section taper being provided between the filling hole and the slot-shaped outlet.
  • the automatic closing effect may be additionally assisted.
  • a taper directed towards the interior of the bag is designed to be provided on the filling hole. Even a slightly tapered portion on the filling hole is sufficient for the filling hole to clog rapidly. This permits a simplified configuration of the closure apparatus.
  • the closure apparatus is designed to close automatically as soon as a pressure difference between an outside of the filling hole and an interior of the bag moves towards zero or the pressure in the interior of the bag is higher than the pressure present at the outside of the filling hole.
  • a closure apparatus equally allows an automatic closing without any intervention from outside, said closing being controllable via the working pressure applied for feeding the filler medium to the barrier.
  • the working pressure present on an outside of the filling hole is higher than the pressure in an interior of the bag.
  • the pressure in the interior of the bag becomes equal to, or higher than, the outside pressure, whereupon the closure apparatus closes automatically.
  • This closure apparatus functioning according to the principle of pressure difference, is preferably realised in the form of a non-return valve inserted into the filling hole of the bag. This allows a simple design configuration and, additionally, assures a rapid closing of the filling hole so as to guarantee a leakage-free configuration.
  • the non-return valve preferably comprises a valve member accommodated within a cage which is preferably realised in the form of a ball valve and, when in a closing position, closes a valve seating formed in particular on the cage.
  • a non-return valve consisting, by way of example, of merely two components, and which closes automatically and reliably on account of the internal pressure present within the bag.
  • the closure apparatus which functions according to the principle of pressure difference, is realised in the form of a diaphragm extending over the entire cross-section within the filling hole and having at least one longitudinal slot.
  • This allows an opening of the preferably flexible diaphragm, as pressure is exerted by the filler medium on the outside of the filling hole.
  • this longitudinal slot closes automatically, preventing the filler medium from escaping from the bag via the filling hole.
  • a cruciform slot is designed to be provided which comprises for example four resilient diaphragm elements or lid-shaped members.
  • said closure apparatus functioning according to the principle of pressure difference, is provided in the form of lid- shaped closing members which extend over the entire cross-section within the filling hole.
  • cusp-shaped closure members are provided which open if the flow of the filler medium is directed towards the interior of the bag and close if the flow is directed in the opposite direction.
  • This configuration represents an alternative arrangement differing from the above-mentioned, slotted diaphragm. Preference is again given to elastic materials working by analogy with the principle that has been described above in connection with the diaphragm having at least one longitudinal slot.
  • said closure apparatus is provided in the form of a reticulate diaphragm in which the width between meshes may be widened when exposed to a pressure increase.
  • This arrangement is in addition accompanied by the operative principle of an increased surface area.
  • the reticulate diaphragm may undergo an increase in surface area which leads to a greater width between meshes so that a flow of the filling material therethrough is enabled.
  • the mesh width is returned to a smaller size or is completely closed, so that a leakage-free arrangement is again created.
  • said closure apparatus is provided in the form of an elastic rubber lip which is spread apart to permit the feeding of a filler medium, contacting an outer periphery of the feeding device in a medium-tight manner, and which closes the filling hole after the feeding device has been disengaged.
  • This configuration permits that the closure apparatus may be created without using any other components.
  • an annular locking member is designed to be provided in the filling hole of the bag, a closure member being insertable into said locking member in order to close said filling hole.
  • the closure member applied to the annular locking member is preferably transferred into a locking position by means of a slide.
  • the rest of the filler medium remaining in the feeding device may thus be transferred into the bag, after which a leakage-free closure may be created on the barrier.
  • the closure member remains on the locking member, whereby again a leakage-free arrangement is created.
  • the bag is designed to be made of such a material, in particular a plastic material, that the bag is stretchable by a ratio of up to 400 %.
  • the bag is designed to be made of a resorbable material.
  • the degree of resorption may be selected for the bag in accor- dance with a particular application.
  • the bag is designed to be at least partially perforated.
  • the filler medium may thus be caused to selectively escape. It is possible, for example, to define individual zones or regions for the escaping of filler medium. At the same time, it is possible, via the size of the perforation holes, to achieve a controlled escaping of filler medium within one such region.
  • the bag is provided with protrusions on its exterior surface that help anchor the bag in its expanded state.
  • An independent inventive aspect relates to an apparatus for expanding bone structures, in particular for the vertebroplastic treatment of fractured vertebrae.
  • the apparatus can be used in a beneficial manner together the barrier disclosed hereinbefore and in the detailed description of the invention hereinafter.
  • An apparatus for expanding fractured vertebral bodies which has a drive member extending along an axis from a proximal end to a distal end of said apparatus is known from WO 2005/110259 A1.
  • This drive member is guided within an insertion sleeve.
  • said drive member has a widening device the proximal end of which abuts on the distal end of said insertion sleeve and the distal end of which is applied on an end piece mounted on said drive member.
  • the widening device comprises at least one elastically deformable, tab-shaped member which expands as a working stroke is performed.
  • a distance between the distal end of the insertion sleeve and the end piece is reduced, causing the elastically deformable, tab-shaped member to expand, forming a semicircle in a plane perpendicular to the longitudinal axis of the drive member.
  • the deformable, elastic, tab-shaped members have the disadvantage, however, of not being sufficiently stiff, due to the flat, tab-shaped configuration thereof, so that an expanded position will not be stable. An outermost point of curvature may become displaced in one direction or the other along the extension of the longitudinal axis. Thus, it may not be possible, or only partially be possible, to exert the forces necessary for expanding the vertebral bodies.
  • an apparatus for expanding bone structures which uses a widening device in which the expansion member has at least two shanks and at least one expansion portion and in which said at least one expansion portion is provided as the central portion in the expansion member and is configured with inherent stiffness, provides the advantage that on actuating the widening device it is thus possible to transmit an increased expansion force to the bone structure in order to widen it.
  • the expansion height and the widening direction may be adaptable according to a particular application. Due to the stiffened configuration of the expansion portion an enlarged contact surface is created on the bone structure to be expanded, thus preventing concentrated load application so as to avoid additional damage to the bone structure.
  • the at least one expansion portion of the widening device is designed to be expandable by reducing a distance between a distal and a proximal shaft end.
  • actuate the widening device by a movement that consist in simply pulling or pushing a grip. This makes it possible, moreover, to create an apparatus having a very small diameter.
  • At least one stiffening member is designed to be disposed on at least one shank, in adjacent relation to said shank on one side or on both sides thereof, between a distal and a proximal shaft end of the widening device and the at least one expansion portion, and on actuating the widen- ing device at least one expansion portion is designed to be expandable in a controlled manner, in particular parallel to a longitudinal axis. Due to this arrangement of at least one stiffening member it is possible to achieve a controlled expansion movement of the expansion portion, as said stiffening member is disposed adjacent to the shank and therefore participates in the expansion movement. Thus it is possible to exert an influ- ence on the expansion portion.
  • the at least one expansion portion is preferably designed to be expanded parallel to the longitudinal axis of the widening device. It may thus be achieved that once a fractured vertebral body, for example, has completely been expanded, the expansion portion contacts the fractured vertebral body with the largest possible surface in order to transmit a greatest possible force.
  • a first buckling point is preferably provided between the shank and the shaft portion of the widening device. Between the shank and the connecting land portion another buckling point is preferably formed. Due to this arrangement, the expansion member, which consists for example of two shanks, may be provided with two defined buckling points and the shank portions lying therebetween may have a geometry permitting an inherently stiffened configuration.
  • an expansion member that consists of two shanks may, for example, have a trapezoidal geometry as it assumes its expanded condition.
  • additional buckling points may alternatively be provided between the first and the other buckling point.
  • the elastically deformable member comprises several shanks.
  • the elastically deformable member may then for example have a polygonal, deflected outer contour.
  • the first buckling point between the shank and the shaft portion of the widening device is preferably formed by two land portions formed by an intermediary buckling opening. Due to this opening in the buckling point a bending may occur without material change, as the shaft portion preferably has a slight curvature in the transition zone leading to the shank and a bending would necessitate an upsetting deformation in the lowermost region of the curvature. By means of this opening in the buckling region of the first buckling point, a plastic deformation of the land portions may be prevented. Since this configuration includes at least one additional stiffening member, the reduced load-bearing strength of the land portions may be compensated by means of the stiffening members.
  • a frusto-conical wall portion is provided in the buckling opening, whereby due to the enlarged perimeter of the opening on the outside of the widening device, which is preferably formed in the shape of a sleeve, a reduced notch effect will occur at the defined buckling point.
  • At least one recess is provided between the shank and the expansion portion in order to form the other buckling point, said recess reducing the width of the shank and preferably extending from the longitudinal edge to the longitudinal central axis of the elastically deformable member.
  • Said recess serves for forming the defined buckling point or serves as a buckling joint and reduces an upsetting deformation of the material on the periphery of the buckling point.
  • the disposition of the recess which is preferably provided on both sides of the expansion member along the longitudinal central axis thereof, has the advantage that a continuous contact surface is created therebetween, so as to enable or maintain a large-surface contact on the vertebral bodies.
  • a buckling opening might be provided, said opening being limited by the land portions provided laterally along the longitudinal edges of the shanks.
  • the stiffening member has a recess for diameter reduction, situated preferably in the region of the other buckling point, which by analogy with the recess on the shank, is formed and oriented in such a way as to form the other buckling point.
  • This recess of the other buckling point is therefore disposed point-symmetrically to the recess of the first buckling point on the stiffening member. This is particularly true of cases in which only one stiffening member is provided between the shaft portion and the expansion portion.
  • the at least one stiffening member corresponding to the shank has a first buckling point located in the transition zone leading to the shaft portion and another buckling point located in the transition zone leading to the expansion portion.
  • defined buckling points are created between the shaft portion and the expansion portion, by analogy with the arrangement and integration of the shank, such that the stiffening member is deflected and expanded concurrently with the shank.
  • the stiffening member is preferably provided with a recess located on the first buckling point, extending from a longitudinal edge towards the longitudinal central axis of the stiffening member and disposed on the stiffening member opposite a longitu- dinal edge of the shank.
  • the other buckling point between the stiffening portion and the expansion portion is preferably formed by analogy with the first buckling point, wherein the recess is located on an opposite side, such that the deflection of the stiffening member relative to the expansion member in the other direction is equally facilitated.
  • a hole with an open rim is designed to be provided in the transition zone leading from the shank and the adjacent stiffening member to the shaft portion.
  • the holes with open rims are designed to be equally provided in the transition zone leading from the shank and the adjacent stiffening member to the expansion portion.
  • the holes with open rims are designed to be equally provided in the transition zone leading from the shank and the adjacent stiffening member to the expansion portion.
  • two opposing, elastically deformable members are designed to form a sleeve and to expand in opposed directions in a plane perpendicular to the longitudinal axis of the widening device.
  • the shanks and the stiffening members are preferably formed by means of cuts realised in the sleeve, such that the round outer contour of the widening device in a starting position is maintained.
  • the shanks, the expansion portion as well as the stiffening members are formed as one piece and are integral with the sleeve wall.
  • an energy storing member is applied to at least one expansion portion of the widening device, permitting to actuate said at least one expansion portion in the widening direction.
  • the energy storing member may be in the form of a pressure spring, for example, or of some other elastically expandable member.
  • a drive member is applied to at least one expansion portion of the widening device, said drive member being operated electrically, pneumatically or hydraulically.
  • Said drive member may be realised as a driving gear, a sliding mechanism, or the like.
  • the at least two shanks accommodating at least one expansion portion are formed of a material that is more elastic as compared to the expansion portion. This permits to achieve an elastic deformation of the shanks and at the same time a concerted expansion of the expansion portion.
  • FIGS. 1a to d are schematic views of individual steps of an operation method using the barrier of the present invention
  • FIGS. 2a to c are schematic views of a first embodiment of the barrier according to the invention provided with a closure device
  • Figures 3a to c are schematic views of an alternative embodiment of the closure device differing from Figures 2a to c,
  • Figures 4a to c are schematic views of an alternative embodiment of the closure device differing from Figures 2a to c,
  • Figures 5a to c are schematic views of an alternative embodiment of the closure device differing from Figures 2a to c,
  • Figures 6a and b are schematic views of an alternative embodiment of the closure device differing from Figures 2a to c,
  • Figures 7a and b are schematic views of an alternative embodiment of the closure device differing from Figures 2a to c,
  • Figures 8a and b are schematic views of an alternative embodiment of the closure device differing from Figures 2a to c.
  • Figure 9 is a schematic view of an apparatus according to the present invention prior to the expansion of a fractured vertebral body
  • Figure 10 is a schematic view of an apparatus according to the present invention during the expansion of a fractured vertebral body;
  • Figure 11a is a schematic side view of a widening device in a starting position;
  • Figure 11 b is a perspective view of the widening device according to Figure 3a in a working position
  • Figure 12a is a schematic side view of an alternative widening device in a starting position
  • Figure 12b is a perspective view of the widening device according to Figure 4a in a working position
  • Figure 12c is a perspective view of an alternative widening device according to Figures 4a and 4b.
  • Figures 1 a to 1 d schematically show a minimally invasive operation technique in the form of individual working steps illustrating the augmentation of a fractured vertebral body and the subsequent vertebroplasty.
  • the barrier 111 formed according to the present invention is used.
  • a fractured vertebral body according to Figure 1a is designed to be prepared for a subsequent expansion operation.
  • a cannula 112 is inserted, for example through the pedicle.
  • the fractured region of the vertebral body may be treated by means of a drill, which is not shown.
  • an apparatus 114 for expanding vertebral bodies is used in order to reduce the vertebral body so as to restore a planned height of the vertebral body. This is done with the help of an widening device or an expansion member having elastically deformable members which may assume the depicted, widened position.
  • a cavity 116 is formed within the fractured vertebral body.
  • a filler medium 119 in particular bone cement, is introduced into said cavity 116 by means of an injection apparatus 118 so as to completely fill said cavity 116 with said filler medium 119.
  • the injection apparatus 118 comprises at least one feeding device 121 and a barrier 111 disposed on the distal end thereof and which is introduced into the cavity 116 via the cannula 112. Subsequently, by means of the feeding device 121 of the injection apparatus 118 the filler medium 119 is introduced into the interior of the barrier 111 , which widens according to Figure 1c until the cavity 116 is completely filled, as is shown in Figure 1 d. Next, the feeding device 121 is separated from the barrier 111 and the cannula 112 is removed.
  • the components remaining within the vertebral body i.e. the barrier 111 and the filler medium 119, serve to fix and stiffen the fragile, osteoporotic or fractured vertebral body in the expanded position.
  • the patients may thus obtain an immediate reduction of pain and recover a better posture and, consequently, an amelioration in their quality of life.
  • a method for augmentation of a fractured vertebral body comprises the steps of:
  • Expansion is preferably done with the help of a widening device or an expansion member having elastically or plastically deformable members which may assume the depicted, widened position.
  • the injection apparatus 118 comprises at least one feeding device 121 and a barrier 111 disposed on the distal end thereof and which is introduced into the cavity 116 via the cannula 112.
  • FIGS 2a to 2c schematically show different views of a first configuration of the barrier 111 according to the present invention.
  • the barrier 111 comprises a bag 123 which encloses an interior 124 for holding the filler medium 119.
  • the interior 124 is accessible via a filling hole 126 arranged in the bag 123, said filling hole being adjoined by an in- ward-turned portion 127 which extends into the interior 124.
  • the inward-turned portion 127 is formed as an integral part of the filling hole 126.
  • the inward- turned portion 127 may also be designed to be joined to the filling hole 26 by bonding or welding.
  • the filling hole 126 preferably has a region into which the feeding device 121 or the distal end thereof is insertable so as to be joined with the filling hole 126 by positive and/or non-positive connection.
  • This first region is adjoined by a cross-section taper 128.
  • the cross-section of the passageway 129 of the inward-turned portion 127 changes in such a way that it turns into a slot-shaped outlet 131.
  • This slot-shaped outlet 131 is beak-like, with two flat edge portions contacting each other in a planiform manner so as to close the slot-shaped outlet 131 when no filler medium is flowing through the passageway 129.
  • the outlet 131 is preferably located in a central region of the interior 124 of the bag 123. This makes it possible, that after the inflow or the introduction of a filler medium 119 into the interior 124 the filler medium 119 may also reach the region of the cross-section taper 128 and that, as the bag 123 progressively fills with the filler medium 119, the cross- section taper 128 is subject to constriction and at the same time a compressive force is exerted on the edge portion of the slot-shaped outlet 131 , so that after the detaching of the feeding device 121 from the filling hole 126 the closure apparatus 125 is caused to close automatically.
  • a leakage-free closure apparatus 125 is created which closes automatically the moment no further filler medium 119 is introduced into the bag 123 or a predefined degree of filling has been reached.
  • Said inward-turned portion 127 is preferably made of the same material as the bag 121. This may involve the utilisation of resorbable materials or other materials.
  • the relationships between size and thickness of the bag 123 as depicted in Figures 2a to 2c are merely exemplary. Different sizes may be provided for differently sized cavities 116 and corresponding geometries.
  • the filling hole 126 may be designed to be provided with a taper which extends into the interior 124 and is realised short, forming what might be considered a tapering rim of the filling hole 126.
  • This preferred configuration also permits a rapid, automatic clogging of the filling hole.
  • Figures 3a to 3c show an alternative embodiment of a closure apparatus 125 for the barrier 111 permitting a leakage-free removal of the feeding device 121 leading to the barrier 111.
  • This closure apparatus 125 is realised in the form of a non-return valve.
  • This non-return valve is comprised, for example, of two components: a cage 133 having a valve seating 134 immediately adjacent thereto and a valve member 136 which contacts the valve seating 134 when in a seated position.
  • the valve member 136 is preferably realised in the form of a ball valve and is lodged within the cage 133.
  • the non-return valve is inserted into the filling hole 126 and is fixedly retained therein. As filler medium 119 is fed via the feeding device 121 , the non-return valve opens so as to permit access of the filler medium 119 to the interior 124 of the bag 123.
  • this closure apparatus 125 functions according to the principle of a pressure difference before and behind the filling hole 126.
  • FIGS. 4a to 4c show an alternative configuration of the closure apparatus 125.
  • This closure apparatus 125 functions equally according to the principle of a pressure difference before and behind the filling hole 126, or before and behind the closure apparatus 125.
  • This closure apparatus 125 is realised in the form of a diaphragm 141 extending over the entire diameter of the filling hole 126.
  • the diaphragm 141 has at least one longitudinal slot 142 which permits the filler medium 119 to pass through the longitudinal slot 142 and enter the interior 124 of the bag 123 when the pressure before the closure apparatus 125 is at an increased level. The moment the pressure in the interior 124 is equal to, or higher than, the pressure outside the interior 124, the longitudinal slot 142 of the diaphragm 141 will close.
  • a leakage-free closure is provided on the barrier 111 which locks and prevents leakage of the filler medium 119 from the bag 123.
  • a cruciform slot or other slotted configura- tions may be provided.
  • Figures 5a to 5c show an alternative configuration of a closure apparatus 125 differing from the closure apparatus 125 according to Figures 4a to 4c.
  • the closure apparatus 125 has cusp-shaped closure members 144 which open if a pressure on the outside is higher than in the interior 124 and which automati- cally close if the pressures present on the outside of the filling hole 126 and in the interior 124 are equal or if the pressure in the interior 124 is higher.
  • four symmetrically assigned closure members 144 may be provided.
  • Figures 6a and 6b show another alternative configuration of the closure apparatus 125.
  • This closure apparatus 125 comprises a reticulate diaphragm 146 that extends equally over the entire cross-section within the filling hole 126.
  • Said reticulate diaphragm 146 or perforated film allows a widening of the individual meshes 147 during the filling operation with a filler medium 119, so that the filler medium 119 may flow through the reticulate diaphragm 146.
  • the mesh size of the reticulate diaphragm 146 returns to its initial state and prevents the filler medium 119, in particular bone cement, from escaping to the outside through the filling hole 126.
  • FIGs 7a and 7b show a further alternative configuration of a closure apparatus 125.
  • an annular locking member 151 is inserted into the filling hole 126, said locking member being preferably attached by means of a non-detachable connection such as bonding, clamping, welding or the like.
  • the locking member 151 may be inserted into the filling hole 126 in such a way as to be replaceable.
  • the filler medium 119 may be introduced into the interior 124 of the bag 123.
  • a closure member 144 is proximally inserted into the feeding device 121.
  • FIGS 8a and 8b show a further alternative configuration of a closure apparatus 125.
  • the closure apparatus 125 comprises a rubber lip 156 which is elastically configured.
  • the rubber lip 156 is spread apart and the end of the feeding device 121 is inserted into the bag 123 through the spread-apart rubber lip 156.
  • the rubber lip 156 fits tight around the outer periphery of the feeding device 121.
  • the feeding device 121 is detached from the filling hole 126 and the rubber lip 156 closes the spread-apart opening.
  • a closure apparatus 125 is created which closes automatically after the feeding device 121 has been detached.
  • FIG. 9 shows an apparatus 211 for expanding bone structures and, by way of example, for expanding fractured vertebral bodies 212.
  • the apparatus 211 corresponds to apparatus 114 of Figure 1.
  • Said apparatus 211 comprises a grip 214 by means of which a widening device 217 is converted, via a drive member 216, from a starting position 218 into a working position
  • the widening device 217 abuts on a distal end of the drive member 216 whereat an end piece 221 is provided.
  • the proximal end of the widening device 217 is applied to an insertion sleeve
  • the drive member 216 is disengageably connected to the grip 214.
  • the drive member may be arranged as a flexible rod or flexible tube, as a Bowden cable or the like.
  • This apparatus 211 is used in particular in minimally invasive surgical operation techniques in the fields of kyphoplasty and also vertebroplasty.
  • the fractured vertebral body is first probed by means of a cannula 224.
  • a cutter may be inserted via the cannula in order to remove the fractured parts from within the vertebral body.
  • the apparatus 211 according to the present invention is inserted via the cannula 224.
  • the grip 214 By actuating the grip 214 the widening device 217, including the elastically deformable expansion members 226 thereof, is caused to expand. In doing so, an expansion force is conveyed to the vertebral body in such a way as to achieve a reduction of the vertebral body.
  • the patient may be placed in a sagging position.
  • the apparatus 211 is removed and the cavity created within the vertebral body is filled with bone cement.
  • the widening device 217 which is only diagrammatically shown in Figures 9 and 10, is schematically represented to a larger scale in a starting position 218 in Figure 11 a, and is schematically represented to a larger scale in a working position 219 in Figure 11 b.
  • the widening device 217 consists of a tube-shaped or sleeve-shaped main body or a sleeve 231. Said sleeve 231 is slipped upon the drive member 216. In order to convert the widening device 217 from a starting position 218 into a working position 219, a distance between a proximal end 232 and the distal end 233 of the widening device 217 is reduced. This causes the elastically deformable expansion members 226 to expand in a plane perpendicular to the longitudinal axis 234 of the drive member 216. In the embodiment shown the widening device 217 comprises two opposing, elastically deformable expansion members 226.
  • the widening device 217 may have only one elastic expansion member 226 or may have several elastically deformable expansion members 226.
  • the elastically deformable expansion members 226 comprises two shanks 236 extending between a shaft portion 237 and an expansion portion 238.
  • the expansion portion 238 in turn connects the two shanks 236.
  • the shanks 236 have a cross-section in the form of a quarter circle. This provides a stiffening of the shanks 236 along said cross-section.
  • a stiffening member 241 is provided adjacent to the shank 236. This stiffening member 241 preferably extends along a longitudinal edge 242 of the shank 236 and is applied on the shaft portion 237 as well as on the expansion portion 238. In this embodiment, a stiffening member 241 is provided on each shank 236 on both sides thereof, respectively. It should be understood that it is equally possible to have only one stiffening member 241 that may be provided on only one shank 236 of the elastically deformable member 226. The number of stiffening members 241 may vary in accordance with a particular application.
  • the stiffening members 241 are configured in an almost rectangular shape, providing a very slight curvature due to the curvature of the wall of the sleeve 231.
  • a first buckling point 244 is formed between the shaft portion 237 and the shank 236, a first buckling point 244 is formed.
  • Said buckling point comprises a buckling opening 246 which has a bore edge 247 that is configured in a frusto-conical shape. The smaller conical surface thereof is oriented towards the longitudinal central axis 234. Because of the radial extension of the buckling opening 246, the shank 236 is connected with the shaft portion 237 via land portions 248. These land portions 248 form a articulation which makes it possible to avoid a plastic deformation in the region of the land portions 248 when the elastic members 226 are expanded.
  • the shank 236 is connected to the expansion portion 238 via another buckling point 244.
  • Said other buckling point 244 is formed by two opposing recesses 252 oriented from the longitudinal edge 242 towards the longitudinal central axis 253. This leads to a reduction in diameter which facilitates a bending of a contact surface 255 from the vertebral body.
  • the contact surface 255 extends over the entire elastically deformable member 226, preferably in a continuous manner, in order to allow a large-surface contact during the expansion of the vertebral body.
  • the stiffening members 241 are configured in a parallel way. These stiffening members 241 assume a guiding in the form of a parallelogram or a parallel guiding and assume part of the supporting force.
  • the stiffening members 241 have respective recesses 252 that are oriented point-symmetrically with respect to one another. In said other buckling point 244, the orientation of the recess is identical with that in the shank 236. In the first buckling point 244, the recess 252 is point-symmetrical with the recess 252 of the other buckling point 244. It can thus be achieved that the central portions of the stiffening members 241 and the longitudinal edges of the shanks 236 are oriented substantially parallel to each other.
  • a hole 258 with an open rim is provided in the transition zone between the land portions 248 and the stiffening member 241 leading to the shaft portion 237. Said hole serves for reducing the notch effect and tear initiation at the transitions toward the individual elements.
  • Such holes 258 with open rims are provided at those locations in the sleeve 231 at which a cut serving to form the deformable member in the sleeve 231 terminates. Therefore, a hole 258 with an open rim is also provided, for example, between two stiffening members 241 at the transition leading toward the shaft portion 237.
  • the expansion of the widening device 217 can be achieved in such a way that for example the expansion portion 238 is oriented parallel to the longitudinal axis 234, which makes it possible to achieve a defined expansion movement.
  • This expansion is further favoured by the fact that the elastic member 226 is symmetrically configured with respect to the shanks 236 and the neighbouring stiffening members 241.
  • the lengths of the shanks and, accordingly, the stiffening members 241 may be designed in such a way as to differ from one another.
  • the elastically deformable member 226 may furthermore be designed to comprise three or more shanks arranged adjacent to one another and preferably connected to an expansion portion 238.
  • the stiffening members 241 accordingly present an analogous structure and an analogous disposition.
  • a retainer 261 permitting a location in correct positional arrangement is provided.
  • Said retainer 261 may be provided as a recess with an open rim. It is also possible to have a depression provided in the end portion of the tube-shaped or sleeve-shaped widening device 217, such that a bolt or pin of the insertion sleeve 222 may engage therewith in order to ensure a rotationally safe accommodation of the widening device 217 relative to the drive member 216 and/or to the grip 214.
  • the drive member 216 may furthermore preferably be designed to present a taper in the region of the widening device 217 which may serve as a reservoir for bone particles that may become detached in the course of the expansion.
  • a guiding mark or scale may be provided on the grip 214. Furthermore, a guiding mark may advantageously be provided between the grip 214 and the shaft in order to make it possible to assess the direction in which the widening device works. This is of particular importance if there exist only two expansion portions working in opposite directions, as is the case in the present embodiment.
  • the grip 214 may additionally be provided with a lever or with a mechanism permit- ting the widening device to be actuated and expanded in an easier manner.
  • suitable locking devices such as bayonet lockings, may preferably be provided in the connection zone between the grip 214 and the drive member 216 as well as the cannula 224 in order to prevent detaching or unintentional twisting.
  • the widening device 217 may be designed to be exposed to a bias, such that a lower expansion force needs to be applied than in cases where the starting position has a sleeve-shaped cross- section.
  • a bias such that a lower expansion force needs to be applied than in cases where the starting position has a sleeve-shaped cross- section.
  • the widening device 217 is preferably made of nitinol. Other materials generally referred to as surgical materials may equally be used.
  • Figures 12a and 12b show an alternative configuration of a widening device 217 differing from the embodiment according to Figures 11a and 11b. As far as the coinciding features are concerned, fully extensive reference is made to Figures 11a and 11 b as well as to their alternative embodiments. In the following, only the differences will be described in greater detail.
  • the two shanks 236 disposed between the expansion portion 238 and the ends 32, 33 of the widening device 217 are each realised in the form of two shanks 236 arranged in pairs with respect to each other.
  • the two shanks 236 arranged in pairs with respect to each other may correspond, in this embodiment, to the stiffening member 241 in Fig. 11b.
  • the expansion portion 238 stretches not merely between the two buckling points 244 but has an extension portion 264 that prolongs the expansion portion 238 on one side or, in particular, on both sides. This permits to create a prolonged contact surface along the longitudinal axis 234 of the widening device 217.
  • the expansion portion 238 with its extension portions 264, and together with the shanks 236 arranged in pairs, may be disposed in a starting position 218 in which, as shown in Fig. 12a, the cross-section assumes the shape of a sleeve.
  • Figure 12c shows another alternative configuration of a widening device 217 differing from the embodiment according to Figures 11a and 11 b.
  • This widening device 217 corre- sponds basically to the embodiment according to Figures 11a and 11 b, to which reference is made, the expansion portion 238 being in addition provided with extension portions 264.
  • extension portions 264 may respectively be attached to the expansion portion 238.
  • one single extension portion 264 may be provided in the region of the expansion portion 238 and attached thereto. This permits to achieve the same advantages as with the embodiment according to Figure 12b.

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  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Neurology (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne une barrière pour une implantation dans un os, en particulier pour une vertébroplastie, la barrière présentant un sac (123) et au moins un trou de remplissage (126) auquel un dispositif d'alimentation (121) pour distribuer un milieu de remplissage (119) peut être attaché, un dispositif de fermeture (125) étant disposé sur ou dans le trou de remplissage (126) qui se ferme ou se bouche automatiquement après l'achèvement du remplissage du sac (123) par un milieu de remplissage (119).
PCT/EP2010/052927 2009-03-06 2010-03-08 Barrière pour implantation dans un os, en particulier pour la vertébroplastie WO2010100287A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102009011561A DE102009011561A1 (de) 2009-03-06 2009-03-06 Barriere zur Implantation im Knochen, insbesondere für die Vertebroplastie
DE102009011566A DE102009011566A1 (de) 2009-03-06 2009-03-06 Vorrichtung zum Aufrichten von Knochenstrukturen
DE102009011566.8 2009-03-06
DE102009011561.7 2009-03-06

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WO2010100287A1 true WO2010100287A1 (fr) 2010-09-10

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WO2012137031A1 (fr) * 2011-04-07 2012-10-11 Vexim Sas Dispositif orthopédique extensible
US8795369B1 (en) 2010-07-16 2014-08-05 Nuvasive, Inc. Fracture reduction device and methods
CN104042366A (zh) * 2013-03-15 2014-09-17 扩张整形外科公司 矫形可扩张装置
JP2014531220A (ja) * 2011-07-15 2014-11-27 グローバス メディカル インコーポレイティッド 椎骨骨折を治療するための方法および器具
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CN105286975A (zh) * 2015-09-09 2016-02-03 苏州爱得科技发展股份有限公司 一种加固型压缩性骨折撑开复位装置
US9408707B2 (en) 2004-06-09 2016-08-09 Vexim Sa Methods and apparatuses for bone restoration
US9579130B2 (en) 2008-04-08 2017-02-28 Vexim Sas Apparatus for restoration of the spine and methods of use thereof
US10603080B2 (en) 2013-12-23 2020-03-31 Vexim Expansible intravertebral implant system with posterior pedicle fixation

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Cited By (19)

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US10813771B2 (en) 2004-06-09 2020-10-27 Vexim Methods and apparatuses for bone restoration
US9408707B2 (en) 2004-06-09 2016-08-09 Vexim Sa Methods and apparatuses for bone restoration
US10098751B2 (en) 2004-06-09 2018-10-16 Vexim Methods and apparatuses for bone restoration
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US9579130B2 (en) 2008-04-08 2017-02-28 Vexim Sas Apparatus for restoration of the spine and methods of use thereof
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ITGE20100144A1 (it) * 2010-12-29 2012-06-30 Mikai S P A Dispositivo percutaneo per il trattamento delle fratture vertebrali
WO2012137031A1 (fr) * 2011-04-07 2012-10-11 Vexim Sas Dispositif orthopédique extensible
US9414933B2 (en) 2011-04-07 2016-08-16 Vexim Sa Expandable orthopedic device
JP2014531220A (ja) * 2011-07-15 2014-11-27 グローバス メディカル インコーポレイティッド 椎骨骨折を治療するための方法および器具
CN104382638A (zh) * 2012-11-28 2015-03-04 上海纳米技术及应用国家工程研究中心有限公司 可降解高分子网状球囊的输送装置
CN104042366B (zh) * 2013-03-15 2017-08-11 扩张整形外科公司 矫形可扩张装置
CN104042366A (zh) * 2013-03-15 2014-09-17 扩张整形外科公司 矫形可扩张装置
US10603080B2 (en) 2013-12-23 2020-03-31 Vexim Expansible intravertebral implant system with posterior pedicle fixation
US11344335B2 (en) 2013-12-23 2022-05-31 Stryker European Operations Limited Methods of deploying an intravertebral implant having a pedicle fixation element
US11998245B2 (en) 2013-12-23 2024-06-04 Stryker European Operations Limited System including an intravertebral implant and a pedicle fixation for treating a vertebral body
CN105286975A (zh) * 2015-09-09 2016-02-03 苏州爱得科技发展股份有限公司 一种加固型压缩性骨折撑开复位装置

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