Bone cement applicator with closure system driven by bone cement dough

• US 10,639,088 B2
• Filed: 11/09/2017
• Issued: 05/05/2020
• Est. Priority Date: 11/11/2016
• Status: Active Grant

• Current Assignee: Heraeus Medical GmbH (Heraeus Holding GMBH)
• Original Assignee: Heraeus Medical GmbH (Heraeus Holding GMBH)
• Inventors: Vogt, Sebastian, Kluge, Thomas
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US15/807,776
• Publication Number:
  US 20180132917A1
• Time in Patent Office: 908 Days
• CPC Class Codes: A61B 17/8811 characterised by the introducer tip, i.e. the part inserted into or onto the bone
• CPC Class Codes: A61B 17/8816 characterised by the conduit, e.g. tube, along which fluid flows into the body or by conduit connections
• CPC Class Codes: A61B 17/8822 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
• CPC Class Codes: A61B 17/8825 characterised by syringe details A61B17/8822, A61B17/8827 take precedence
• CPC Class Codes: A61B 17/8833 Osteosynthesis tools specially adapted for handling bone cement or fluid fillers; Means for supplying bone cement or fluid fillers to introducing tools, e.g. cartridge handling means
• CPC Class Codes: A61B 2017/8838 for mixing bone cement or fluid fillers
• CPC Class Codes: A61C 5/64 for multi-component compositions
• CPC Class Codes: A61M 5/284 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: A61M 5/285 with sealing means to be broken or opened
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type

Abstract

One aspect relates to a bone cement applicator for mixing and applying a bone cement, with which the starting components of the bone cement is mixable in a closed cartridge to form a bone cement dough. The cartridge has a multi-part closure system including a discharge opening. At least two parts of the closure system are movable relative to one another, driven by a movement of the mixed bone cement dough, and the discharge opening is opened the movement of the at least two parts of the closure system relative to one another. The movement of the mixed bone cement dough is drivable by a pressure on the bone cement dough.

Claims

1. A bone cement applicator for mixing and applying a bone cement, with which the starting components of the bone cement is mixable in a closed cartridge to form a bone cement dough, wherein the cartridge has a multi-part closure system comprising a discharge opening, wherein at least two parts of the closure system are movable relative to one another, driven by a movement of the mixed bone cement dough, and the discharge opening is opened by the movement of the at least two parts of the closure system relative to one another, and wherein the movement of the mixed bone cement dough is drivable by a pressure on the bone cement dough, wherein the closure system comprises a wall that is gas-permeable, but impermeable for powder and liquids, wherein the wall is arranged in the cartridge in such a way that the pressure of the bone cement dough acts on the wall, and thus moves a stopper or a cover with the wall relative to the cartridge and thus opens the cartridge, or thus moves a discharge opening with the wall relative to the cartridge and thus removes a stopper, which is fixedly connected to the cartridge, from the discharge opening, and wherein the wall comprises a porous plate.

2. The bone cement applicator according to claim 1, characterized in that the bone cement dough is then dischargeable through the opened discharge opening with the same pressure on the bone cement dough as the pressure used to open the closure system.

3. The bone cement applicator according to claim 1, characterized in that the closure system has a wall with the discharge opening and a stopper, wherein the discharge opening is connected to the surrounding environment of the cartridge and the stopper closes the discharge opening when the cartridge is closed, wherein either the wall with the discharge opening is movable by the pressure of the bone cement dough and the stopper is fixed relative to the cartridge, or the stopper is movable by the pressure of the bone cement dough and the wall is fixed or fixable relative to the cartridge.

4. The bone cement applicator according to claim 1, characterized in that the cartridge has a cylindrical interior, in which the bone cement dough is mixed, and the pressure on the bone cement dough to open the closure system and to drive out the bone cement dough from the opened cartridge is generatable by linearly advancing a discharge piston mounted axially movably in the interior of the cartridge in the direction of the closure system, and in the direction of a cartridge head of the cartridge, wherein the closure system is disposed at the front side of the cartridge.

5. The bone cement applicator according to claim 4, characterized in that the powder is contained in a front part of the interior of the cartridge and a container containing the monomer liquid is arranged in a rear part of the interior of the cartridge, wherein the discharge piston is arranged between the container and the powder, and the conveying piston is arranged at a cartridge base opposite the closure system, wherein a conduit means is provided, which connects the front part and the rear part of the interior of the cartridge to one another in a manner permeable for the monomer liquid and for gases and which is impermeable for the powder.

6. The bone cement applicator according to claim 5, characterized in that at least one feedthrough is provided in the discharge piston and/or between the discharge piston and the inner wall of the interior as conduit means, by which the front part of the interior and the rear part of the interior are connected to one another, wherein a filter impermeable for the powder and permeable for the monomer liquid and gases is arranged in or on the at least one feedthrough.

7. The bone cement applicator according to claim 5, characterized in that a detent means is arranged on the discharge piston, so that the discharge piston can latch with the cartridge between the front and the rear part of the interior, wherein this latching cannot be released by the forces occurring as the container is opened and a pressure exerted onto the monomer liquid by the conveying piston, but is releasable by a pressure acting on the discharge piston directly from the conveying piston.

8. The bone cement applicator according to claim 5, characterized in that the volume of the monomer liquid in the container is at least as large as the volume of the gaps filled with air between the powder particles in the front part of the interior of the cartridge, or is at least as large or exactly the same size as the volume of the gaps filled with air between the powder particles in the front part of the interior and the rear part of the interior when the conveying piston bears against the discharge piston, minus the volume of the material of the container and, as applicable, the volume of a filling material in the rear part of the interior.

9. The bone cement applicator according to claim 5, characterized in that a receiver for excess monomer liquid is provided at the front end of the cartridge or in a cartridge head at the front side of the cartridge, wherein the powder cannot enter the receiver, wherein the receiver is a hydrophilic spongy structure.

10. The bone cement applicator according to claim 5, characterized in that the powder is pressed into the front part of the interior, and is under pressure in the front part of the interior.

11. The bone cement applicator according to claim 1, characterized in that in order to mix the bone cement dough, a monomer liquid as a first starting component of the bone cement within the cartridge is pushable by a conveying piston into a powder as second starting component, wherein the conveying piston is pushed in the direction of the closure system, wherein the conveying piston is arranged axially movably in a cylindrical interior of the cartridge.

12. The bone cement applicator according to claim 1, characterized in that the cartridge is composed of a front cartridge part and a rear cartridge part, which are fixedly connected and screwed to one another, and wherein a cartridge head is fastened to the front cartridge part.

13. The bone cement applicator according to claim 1, characterized in that in the cartridge, a monomer liquid is contained as first starting component and a powder is contained as second starting component, from which the bone cement dough is mixed within the cartridge, wherein a hydrophilic additive is distributed in the powder, with which additive the monomer liquid is distributable throughout the powder, without a polymerisation of the bone cement beforehand preventing the further distribution of the monomer liquid in the powder.

14. The bone cement applicator according to claim 1, characterized in that the powder comprises at least one particulate polymethyl methacrylate or polymethyl methacrylate copolymer of the sieve fraction smaller than 100 μ

m, an initiator, and at least one particulate or fibrous additive that is insoluble in methyl methacrylate, wherein the additive has an absorption capacity of greater than or equal to 0.6 g of methyl methacrylate per gram of additive at room temperature.

15. The bone cement applicator according to claim 1, characterized in that the interior of the cartridge is connected to the surrounding environment of the bone cement applicator by a connection which is impermeable for the powder, but permeable for gases, wherein the connection is formed by a stopper and/or plastic ring and/or passageway in the wall of the cartridge which is impermeable for the powder but permeable for gases.

16. A bone cement applicator for mixing and applying a bone cement, with which the starting components of the bone cement is mixable in a closed cartridge to form a bone cement dough, wherein the cartridge has a multi-part closure system comprising a discharge opening, wherein at least two parts of the closure system are movable relative to one another, driven by a movement of the mixed bone cement dough, and the discharge opening is opened by the movement of the at least two parts of the closure system relative to one another, and wherein the movement of the mixed bone cement dough is drivable by a pressure on the bone cement dough, wherein a discharge tube with the discharge opening is mounted movably relative to the cartridge, wherein a stopper, which closes the discharge tube, is fixedly connected to the cartridge and the discharge tube is movable relative to the stopper by the pressure on the bone cement dough and is thus openable.

17. The bone cement applicator according to claim 16, characterized in that the discharge tube is pushable in a direction away from a cartridge base by a pressure on the side of the bone cement dough facing towards the cartridge base, and in so doing the stopper is released from the discharge tube and thus opens the cartridge.

18. A method for applying a bone cement, comprising:

exerting a pressure onto a bone cement dough in a cartridge closed by a closure system;

exerting a force conveyed from the bone cement dough by the pressure onto a part of the closure system movable relative to the cartridge, thus moving the part of the closure system relative to the cartridge; and

opening the cartridge on account of the movement of the part of the closure system, driving out the bone cement dough from the opened cartridge with the same pressure.

19. The method according to claim 18, characterized in building up the pressure on the bone cement dough by a force which is exerted onto a discharge piston movable linearly in the cartridge.

20. The method according to claim 18, characterized in that the movable part of the closure system is a cover or a stopper, wherein the cover or the stopper is moved relative to a wall with a discharge opening, which is fixed relative to the cartridge, or the movable part of the closure system is a wall with a discharge opening, wherein a cover or a stopper which closes the discharge opening in the starting position is fixed relative to the cartridge.

21. The method according to claim 18, characterized in moving a conveying piston in a cylindrical interior of the cartridge in the direction of a front side of the cartridge, wherein a discharge piston is arranged between the conveying piston and the front side of the cartridge,

pressing a monomer liquid as first starting component of the bone cement, which is arranged between the conveying piston and the discharge piston, by means of the movement of the conveying piston towards the discharge piston into a front part of the interior between the discharge piston and the front side containing a powder as second starting component of the bone cement, wherein the bone cement dough is thus produced, and

the conveying piston contacting the discharge piston and the conveying piston then pushing the discharge piston in the direction of the front side of the cartridge, wherein the closure system is opened by the pressure exerted onto the bone cement dough by the discharge piston.

22. A method according to claim 21, characterized in opening a container for the monomer liquid, which is arranged between the conveying piston and the discharge piston in the interior of the cartridge, by the movement of the conveying piston in the direction of the discharge piston, wherein a glass ampoule or a plastic ampoule as container between the conveying piston and the discharge piston is shattered, or a film bag as container is ripped, pierced or torn open, and the monomer liquid is then pressed out from the film bag.

23. The method according to claim 18, characterized in that the cartridge is inserted into a press-out apparatus and a ram of the press-out apparatus is advanced, wherein the pressure on the bone cement dough is produced by advancing the ram, wherein a conveying piston is driven in the direction of the closure system by means of the ram.

24. The method according to claim 18, characterized in that in order to produce the bone cement dough, a monomer liquid as first starting component of the bone cement dough is distributed in a powder as second starting component of the bone cement dough with the aid of a hydrophilic additive in the powder, wherein the powder is compressed or contained under a mechanical pressure in a front part of the interior of the cartridge.