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EP1928365A1 - Systeme d'application de ciment a os - Google Patents

Systeme d'application de ciment a os

Info

Publication number
EP1928365A1
EP1928365A1 EP06792016A EP06792016A EP1928365A1 EP 1928365 A1 EP1928365 A1 EP 1928365A1 EP 06792016 A EP06792016 A EP 06792016A EP 06792016 A EP06792016 A EP 06792016A EP 1928365 A1 EP1928365 A1 EP 1928365A1
Authority
EP
European Patent Office
Prior art keywords
application
bone cement
application device
line
application line
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.)
Withdrawn
Application number
EP06792016A
Other languages
German (de)
English (en)
Inventor
Volker Trösken
Martin Deli
Jürgen SPEDER
Katja Gonschorek
Ronald Kontek
Marion Denk
Dietrich GRÖNEMEYER
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.)
Amedo GmbH
Original Assignee
Amedo 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
Application filed by Amedo GmbH filed Critical Amedo GmbH
Publication of EP1928365A1 publication Critical patent/EP1928365A1/fr
Withdrawn legal-status Critical Current

Links

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
    • A61B17/88—Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8816—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
    • 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
    • A61B17/8802—Equipment for handling bone cement or other fluid fillers
    • A61B17/8805—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it
    • A61B17/8822—Equipment for handling bone cement or other fluid fillers for introducing fluid filler into bone or extracting it characterised by means facilitating expulsion of fluid from the introducer, e.g. a screw pump plunger, hydraulic force transmissions, application of vibrations or a vacuum

Definitions

  • the invention relates to an application device for bone cement, in particular for use in vertebroplasty, with an application line, through which the bone cement can be brought in the direction of the destination, and a longitudinally movable within the application line, flexible piston rod with a piston located at the distal end of the piston rod, which sealingly abuts the inner wall of the application line, wherein the piston rod protrudes proximally from the application line.
  • Vertebroplasty is a comparatively new treatment method, which can be used in particular for diseases of the spine or other bones. Often, in diseases such. As osteoporosis caused by the increasing loss of bone mass pain. In vertebroplasty (or osteoplasty), a relatively viscous bone cement is incorporated to compensate for the loss of bone mass. In particular, vertebroplasty can be effectively used to stabilize fractured vertebral bodies by injecting a bone cement into the interior of the porous vertebral body under pressure to effectively join the individual pieces of the vertebral body together.
  • the filling of the vertebral body is usually carried out under X-ray control, whereby the vertebral body or bone to be treated is punctured with the aid of a vertebroplasty needle.
  • the bone cement used is often polymethylmethacrylate (PMMA), calcium phosphate or similar materials that are mixed just before application and injected into the vertebral body. Injection takes place via a vertebroplasty needle, to which several syringes filled with approx. 1 ml bone cement are connected one after the other.
  • Such an application device usually consists of an application line, through which the bone cement can be brought in the direction of its destination, such as a longitudinally movable within the application line piston, so sucked by movement of the piston in the proximal direction bone cement into the device and by advancing in distal direction bone cement can be pushed out of the application device.
  • an application line through which the bone cement can be brought in the direction of its destination, such as a longitudinally movable within the application line piston, so sucked by movement of the piston in the proximal direction bone cement into the device and by advancing in distal direction bone cement can be pushed out of the application device.
  • a longitudinally movable within the application line piston so sucked by movement of the piston in the proximal direction bone cement into the device and by advancing in distal direction bone cement can be pushed out of the application device.
  • tion line located bone cement can be exercised.
  • DE 103 53 919 A1 discloses an injection pump which has a long pump body with a small surface volume, so that expressing the high-viscosity bone cement from the distal opening is possible even by a small exertion of force. For this reason, no more screwing is needed, but it is here possible to move the piston via a connected to the piston partially rigid, partially flexible piston rod back and forth.
  • the injection pump described in the last-mentioned document also has disadvantages in various respects.
  • the amounts of bone cement that can be introduced with such an application device are comparatively small and are at the most of the order of 4 ml.
  • the application device or several application devices must be used. to completely fill the vertebral body or bone to be treated.
  • the bone cement already begins to cure after six to seven minutes, the doctor must work under considerable time pressure, which can lead to insufficient filling of a vertebral body.
  • the task is to provide an application device available, which overcomes the disadvantages known from the prior art and makes the injection of bone cement with relatively little effort possible, while providing good feedback for the doctor as well a high capacity of bone cement should be given.
  • an application device for bone cement in particular for use in vertebroplasty, with an application line through which the bone cement in the direction of destination can be brought, and a longitudinally movable within the application line, flexible piston rod with a located at the distal end of the piston rod Piston which sealingly abuts the inner wall of the application line, wherein the piston rod protrudes proximally from the application line and wherein the application line extends at least partially in one or more windings.
  • the application device Because relatively small forces have to be expended, it is also possible to operate the application device with only one hand, which also makes handling easier.
  • the application device according to the invention a distance between the patient and the doctor is ensured, in which the physician on the one hand is sufficiently close to the patient, so that the handling of the application device is unproblematic, but on the other hand, there is still sufficient distance from the patient.
  • the latter is important because usually the filling of the vertebral body is made under X-ray control, so that a certain distance between the patient and the doctor must be observed so that the hands of the doctor are not in the beam path when operating the delivery system.
  • the flexible piston rod can be advantageously wound on a drum.
  • This drum can z. B. be cylindrical. In this way it is achieved that the entire application device is not too long and unwieldy even behind the application line itself. Possibly. one can use the winding of the flexible piston rod on the drum to move back and forth by rotating the drum, the piston rod and thus also located at the distal end of the piston rod piston within the application line. By moving back the piston bone cement is sucked into the application device, by advancing the piston, the bone cement is discharged at the distal end of the application device. To be able to turn the drum, it can have a kind of crank or the like.
  • the piston rod is forward and / or adoptedbewegbar via a ratchet mechanism.
  • a ratchet mechanism is basically known, for example, from the German Utility Model DE 201 18 100 U 1 and is similarly used for expressing Dichtungskartuschen, z. As for silicone, used.
  • Such a ratchet mechanism has a piston rod, which is at least partially toothed, wherein a handle is provided on the application device, via which a pawl can be actuated, which causes the toothed piston rod to move distally when the handle is actuated.
  • a handle is provided on the application device, via which a pawl can be actuated, which causes the toothed piston rod to move distally when the handle is actuated.
  • Possibly. can, as described in DE 201 18 100 U1, on a pawl that the return obstructing the piston obstructed, can be dispensed to allow rapid pressure relief when needed.
  • a manual actuation of the piston rod and a motor-driven forward and / or backward movement is possible.
  • a small electric motor can be attached to the drum on which the flexible piston rod is wound to suck the bone cement into the application device.
  • the application of a motor is less advantageous because this process is manually controlled by the doctor better.
  • the inner diameter of the application line is advantageously 2 to 5 mm, more preferably 2.5 to 3 mm. Such a diameter is significantly lower than that of the currently commercial application devices. Due to the small diameter, the favorable pressure ratio described above is achieved, so that by applying relatively low forces, a sufficiently high pressure is produced, which ensures a sufficient penetration of the bone structure. Commercially available application devices, however, usually have a considerably larger inner diameter, so that a sufficient pressure can be built only by applying considerable forces, which is sometimes only possible by a screwing.
  • the usable volume of the application line is so high that the entire required amount of bone cement can be injected at one time into the vertebral body or bone.
  • the usable volume of the application line is approximately in the range of 4 to 10 ml.
  • the usable volume is about 7 ml.
  • the length of the application line must be selected according to the desired usable volume and the inner diameter of the application line. For example, a volume of 7 ml with an inner diameter of 3 mm requires a usable length of the application line of about 1 m, wherein it should be noted that not the total length of the application line for bone cement is available, as always the piston rod with its on lo Partially distal piston protrudes partially into the application line. If you trained the application line stretched with such a length, the entire application device would be extremely unwieldy and the doctor would have a considerable distance from the patient. Due to the fact that the application line runs in one or more windings, in particular helically or helically wound or wound, it is achieved that the overall dimensions of the application device are within reasonable limits.
  • the application line should have connection possibilities for a cannula or needle with which, for example, the vertebrae to be treated can be connected.
  • a corresponding connecting piece such as a spout, be connected to the distal end of the application line, which is immersed in the viscous bone cement. Subsequently, this connector is removed and connected the application device to the Vertebroplastienadel. Both vertebroplasty needle and the connector
  • the application line 30 sucking of the bone cement can be connected via a Luer-Lock connection, for example, which is frequently used in medical technology.
  • the application line must also be provided so that it easily withstands the applied pressures. Possibly. this is a reinforcement of the line to the outside, for example by a metal braid useful.
  • the application line may, for example, be in the form of a tube which is itself flexible enough to be wound helically or helically, but alternatively it is also possible to manufacture the application line from metal, for example, and from the outset a helical or spiral shape provide the application line, in the latter case, the application line remains permanently in this form due to lack of flexibility.
  • the application line is provided with a cooling system.
  • a cooling system This is advantageous in that the bone cement is usually mixed together outside of the body of a powder and a liquid and the curing process depends on the temperature. The lower the temperature, the slower the bone cement hardens.
  • common bone cements have a pot life, d. H. a period of time between mixing the components and gelling the mixture, from about 3 to 18 minutes. Thereafter, the bone cement is no longer applicable. Since the period is relatively short, the attending physician must work very quickly, which is not unproblematic given the necessary accuracy.
  • the treatment is provided with a cooling system.
  • the application line is cooled to a temperature of about 5 to 12 ° C, which corresponds approximately to a doubling of the pot life.
  • the cooling can be regulated as needed to z. B. to ensure greater cooling at high outside temperatures.
  • the cooling can be achieved for example by guided around the application line around cooling coils.
  • Peltier elements of which one or more can be attached to the application line, are particularly preferred as cooling systems.
  • Peltier technology is very cost-effective, maintenance-free, noiseless and compact and therefore particularly suitable for the application device according to the invention.
  • FIG. 1 shows a schematic representation of the application device according to the invention.
  • the application device has an application line 1, through which a movable, flexible piston rod 2 extends, which has a piston 3 at its distal end.
  • the terms distal and proximal are to be understood in the context of this invention as proximal meaning "to the physician's body when used as intended” while the distal end is the end remote from the physician's body from proximal to distal in the vertebroplasty cannula and finally injected into the vertebral body
  • the distal end corresponding to the left, the proximal end to the right to recognize.
  • the piston 3 located at the distal end of the piston rod can be moved back and forth by actuating the piston rod 2 in the application line 1. It is important here that the piston 3 sealingly abuts against the inner wall of the application line 1, which is why the piston 3 usually has corresponding sealing elements in the edge region.
  • the piston 3 in the application line 1 In order to inject bone cement into the vertebral body, the piston 3 in the application line 1 must be moved in the direction of the arrow 4, while bone cement can be sucked into the application device by retracting the piston 3.
  • the application line is at least partially helix-wound or helically wound or wound.
  • FIG. 1 shows an inverted winding 5, whereby only one turn 5 is shown here for better representability, but usually such an application device has several windings 5.
  • the number of turns 5 is determined by how the total length of the application device in relation to the usable inner length of the application line 1 is to be set, which depends primarily on the volume required for bone cement.
  • the windings 5 can form a helix or a spiral, wherein here under a helical shape a is understood, in which the axis of the helix of the longitudinal axis of the application device substantially corresponds, while a helical arrangement has an axis of the spiral perpendicular to the longitudinal axis of the application device.
  • a is understood, in which the axis of the helix of the longitudinal axis of the application device substantially corresponds, while a helical arrangement has an axis of the spiral perpendicular to the longitudinal axis of the application device.
  • the application line 1 runs at least partially in one or more windings, the exact arrangement of the windings 5 plays no role in the basic mode of operation.
  • the piston rod 2 is wound on a drum 6, so that the entire application device remains easy to handle overall, even if the piston rod 2 has almost completely moved out of the application line 1 in the proximal direction.
  • the application device has a handle 7 which actuates a ratchet mechanism with the aid of which the piston can be advanced in the distal direction.
  • the application line 1 in conjunction with the piston rod 2 has a scaling, by means of which the doctor can recognize which volume of bone cement he has already introduced into the vertebral body. With the help of the handle 7, the application device can be operated with only one hand, which greatly simplifies handling.

Landscapes

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

Abstract

L'invention concerne un dispositif d'application de ciment à os notamment destiné à la vertébroplastie, comportant une conduite d'application (1) destinée à transporter le ciment à os vers le lieu d'application, et une tige à piston flexible (2) coulissant longitudinalement dans la conduite d'application (1), comportant un piston (3) situé sur l'extrémité distale de la tige (2), s'appuyant de façon jointive contre la paroi intérieure de la conduite d'application (1). La tige de piston (2) fait saillie de façon proximale hors de la conduite d'application (1), la conduite d'application (1) se présentant au moins partiellement sous la forme d'un ou plusieurs enroulements (5).
EP06792016A 2005-09-22 2006-09-13 Systeme d'application de ciment a os Withdrawn EP1928365A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102005045227A DE102005045227A1 (de) 2005-09-22 2005-09-22 Knochenzementapplikationssystem
PCT/EP2006/008897 WO2007033783A1 (fr) 2005-09-22 2006-09-13 Systeme d'application de ciment a os

Publications (1)

Publication Number Publication Date
EP1928365A1 true EP1928365A1 (fr) 2008-06-11

Family

ID=37682578

Family Applications (1)

Application Number Title Priority Date Filing Date
EP06792016A Withdrawn EP1928365A1 (fr) 2005-09-22 2006-09-13 Systeme d'application de ciment a os

Country Status (4)

Country Link
US (1) US20090204120A1 (fr)
EP (1) EP1928365A1 (fr)
DE (1) DE102005045227A1 (fr)
WO (1) WO2007033783A1 (fr)

Families Citing this family (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB0419946D0 (en) * 2004-09-08 2004-10-13 British Telecomm High data rate demodulation system
US8241295B2 (en) * 2007-09-05 2012-08-14 Wolf Ii Erich W Apparatus and method for the dispensing of bone cement
US9095393B2 (en) 2012-05-30 2015-08-04 Carefusion 2200, Inc. Method for balloon-aided vertebral augmentation
US20110112507A1 (en) * 2009-11-10 2011-05-12 Carefusion 207, Inc. Curable material delivery systems and methods
US8226657B2 (en) 2009-11-10 2012-07-24 Carefusion 207, Inc. Systems and methods for vertebral or other bone structure height restoration and stabilization
US8894658B2 (en) 2009-11-10 2014-11-25 Carefusion 2200, Inc. Apparatus and method for stylet-guided vertebral augmentation
WO2011119799A1 (fr) * 2010-03-24 2011-09-29 Nordson Corporation Dispositif de distribution de fluide
US8968323B2 (en) * 2010-11-22 2015-03-03 Warsaw Orthopedic, Inc. Bone graft injection syringe
US9370389B2 (en) * 2011-11-01 2016-06-21 David Bradley JONES Biologic injection system
DE102016113467B4 (de) 2016-07-21 2023-01-26 Heraeus Medical Gmbh Knochenzement-Applikator mit Dreiwege-Ventil zur Druckentlastung und Verfahren zum Auspressen eines Knochenzements mit dem Knochenzement-Applikator
DE102016113468A1 (de) 2016-07-21 2018-01-25 Heraeus Medical Gmbh Knochenzement-Applikator mit Dreiwege-Ventil zur Druckentlastung
DE102017104854B4 (de) 2017-03-08 2019-05-29 Heraeus Medical Gmbh Zweiteilige Lager- und Mischvorrichtung zur Herstellung eines Knochenzements und Verfahren hierzu
DE102017107569A1 (de) 2017-04-07 2018-10-11 Heraeus Medical Gmbh Vorrichtung zum Lagern, Vermischen und Austragen eines Knochenzements und Verfahren hierzu
US10945860B2 (en) * 2019-04-19 2021-03-16 James Scott Hay Biologic preparation and delivery system

Family Cites Families (5)

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Publication number Priority date Publication date Assignee Title
US4472141A (en) * 1981-10-26 1984-09-18 Dragan William B All purpose dental syringe
US6086594A (en) * 1998-10-16 2000-07-11 Brown; Byron L. Cement pressurizing device
US6547432B2 (en) * 2001-07-16 2003-04-15 Stryker Instruments Bone cement mixing and delivery device for injection and method thereof
US7909833B2 (en) * 2003-09-29 2011-03-22 Depuy Acromed, Inc. Vertebroplasty device having a flexible plunger
DE10353919A1 (de) * 2003-11-18 2005-07-07 Somatex Medical Technologies Gmbh Injektionspumpe

Non-Patent Citations (1)

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Title
See references of WO2007033783A1 *

Also Published As

Publication number Publication date
DE102005045227A1 (de) 2007-03-29
US20090204120A1 (en) 2009-08-13
WO2007033783A1 (fr) 2007-03-29

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