KIT FOR PRODUCING AND EXTRUDING BONE CEMENT, AND METHOD

Abstract

A kit for producing and extruding bone cement, to a use of a kit, and to a method. A kit for producing and extruding bone cement comprises a first container which contains a first component for producing bone cement, a second container which contains a second component for producing bone cement, a mixing apparatus for manually mixing the first component and the second component in the first container for the purpose of producing bone cement, and an extruding apparatus for manually extruding the produced bone cement from the first container. In this way, all materials and apparatuses required for the production and extrusion of bone cement are provided together.

Claims

1. A kit for producing and extruding bone cement, comprising: a first container which contains a first component for producing bone cement, a second container which contains a second component for producing bone cement, a mixing apparatus for manually mixing the first component and the second component in the first container for the purpose of producing bone cement, an extruding apparatus for manually extruding the produced bone cement from the first container.

2. The kit according to claim 1 wherein the mixing apparatus is at least partially arranged in the first container, wherein the extruding apparatus has an axial extension A, and the first container with the mixing apparatus has an axial extension B, wherein, for the ratio A/B, the following applies:
A/B0.9 and/or A/B1.5.

3. The kit according to claim 1 wherein the extruding apparatus comprises a threaded rod with an external thread, a handle for rotating the threaded rod, and an adapter unit for mechanically connecting to the first container, wherein the adapter unit comprises a passage opening with an internal thread for the threaded rod.

4. The kit according to claim 3 wherein the outer surface of a thread turn of the external thread is at most 370 mm.sup.2 and/or at least 230 mm.sup.2.

5. The kit according to claim 1 wherein the extruding apparatus is designed to extrude the bone cement from the first container with an extruding force of at least 0.7 kN, in particular at least 1.0 kN.

6. The kit according to claim 1 wherein the kit comprises a packaging means, and the components of the kit are enclosed in the packaging means, in particular so as to be airtight and/or sterile.

7. The kit according to claim 1 wherein the first container contains as the first component an amount of at least 40 g of a PMMA bone cement powder, and/or in that the second container contains as the second component an amount of at least 18 ml of a monomer liquid.

8. The kit according to claim 1 wherein the second container is arranged in an apparatus for storing and opening the second container, wherein the apparatus for storing and opening the second container is or can be fluidically connected to the first container in order to transfer the second component into the first container.

9. The kit according to claim 1 wherein the first container and/or the second container is arranged separately from the extruding apparatus.

10. The kit according to claim 1 wherein the mixing apparatus is at least partially arranged in the first container, wherein the first container with the mixing apparatus and the extruding apparatus are arranged in parallel, preferably one above the other.

11. The kit according to claim 1 wherein the first container, the second container, the mixing apparatus and the extruding apparatus consist in total of a maximum of 20% metal.

12. The kit according to claim 3 wherein the adapter unit is or can be mechanically connected to the first container, wherein the adapter unit comprises a support surface for standing the adapter unit with the first container on a smooth surface and/or on a holder of the packaging means, in particular wherein the packaging means comprises a corresponding holder.

13. The kit according to claim 8 wherein the apparatus for storing and opening the second container: comprises a buckling region for buckling the apparatus such that the second container can be opened by buckling, or comprises an outer shell, an inner shell, and a shearing element, wherein the outer shell and the inner shell are displaceable relative to each other, and the second container is moved by the relative displacement with respect to the shearing element in order to open the second container by shearing a part of the second container.

14. Use of a kit according to claim 1 for pressing out an amount of between 50 g and 130 g of bone cement from the first container.

15. A method for using a kit according to claim 1, comprising: mixing the first component with the second component in the first container using the mixing apparatus for the purpose of producing bone cement, removing the extruding apparatus from a packaging means of the kit, extruding the produced bone cement from the first container using the extruding apparatus.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0084] In the drawings:

[0085] FIG. 1: is a kit according to the invention in plan view,

[0086] FIG. 2: is a kit according to the invention in side view,

[0087] FIG. 3: is a kit according to the invention in a perspective view,

[0088] FIG. 4: is a kit according to the invention in plan view,

[0089] FIG. 5: shows components of a kit according to the invention,

[0090] FIG. 6: shows a component of a kit according to the invention,

[0091] FIG. 7: shows components of a kit according to the invention,

[0092] FIG. 8: shows components of a kit according to the invention,

[0093] FIG. 9: shows components of a kit according to the invention,

[0094] FIG. 10: shows components of a kit according to the invention,

[0095] FIG. 11: shows components of a kit according to the invention,

[0096] FIG. 12: shows components of a kit according to the invention,

[0097] FIG. 13: is a sectional view of an extruding apparatus,

[0098] FIG. 14: is a further sectional view of an extruding apparatus,

[0099] FIGS. 15A-15C: show details of an extruding apparatus in a first container,

[0100] FIG. 16: shows an enlarged detail of a threaded rod, and

[0101] FIGS. 17A-17C: are several views of a first container on or in a packaging means.

DETAILED DESCRIPTION OF THE INVENTION

[0102] FIGS. 1 and 2 show a kit 10 according to the invention for producing and extruding bone cement. The kit comprises a first container 12, a second container 70, an extruding apparatus 10 and a mixing apparatus 74. The mixing apparatus 74 is mechanically connected to the first container 12 so that after transferring the second component from the second container 70 into the first container 12 that contains the first component, the two components can be mixed with the mixing apparatus 74 to obtain bone cement. The kit also includes a knee snorkel 54 and a flat snorkel 55 as well as a vacuum hose 50 for connecting the first container 12 to a vacuum source.

[0103] The second component can advantageously be sucked into the first container 12 by means of a vacuum. However, with the design shown here, operation without vacuum is also possible. To the right next to the first container 12, a pumping device 11 is arranged which can be used to pump the liquid into the first container. The pumping device can be designed as described in DE 10 2015 106 899 B3, which is incorporated into this application by reference.

[0104] The kit further comprises a packaging means 77 in which the components are in particular packed. The packaging means 77 comprises an in particular deep-drawn tray 78 with a widened, circumferential edge and a cover 79 which is attached to the edge, for example welded or glued. The packaging means 77 has a substantially square basic shape.

[0105] The mixing apparatus 74 is partially arranged in the first container 12. For the axial extension A of the extruding apparatus 10 and the axial extension B of the first container 12 with the mixing apparatus 74, A/B is between 1.0 and 1.2. In the case shown here, A/B is approximately 1.1.

[0106] FIGS. 3 and 4 show other embodiments of a kit 1 in which the packaging means 77 has an elongated basic shape. In the embodiment shown here, the kit 1 includes an apparatus 85 for storing and opening the second container, which contains the second container 70. The apparatus 85 is mechanically connected, in particular reversibly, to the first container 12. This facilitates use because the connection does not have to be established first. FIG. 3 shows a two-part extruding apparatus 10. An adapter unit 26 of the extruding apparatus is mechanically connected to one end of the first container 12, on the side opposite the apparatus 85. A hand part of the extruding apparatus 10 with a threaded rod 20 and handle 24 is arranged separately therefrom and/or next to it. The adapter unit 26 can have, on the side facing away from the first container 12 in relation to the axial extension, a support surface for standing on a smooth surface and/or on a holder of the packaging means (cf. FIGS. 15A to 15C). This makes it easier to stand the first container 12 for mixing and/or after mixing.

[0107] In the embodiment shown in FIG. 4, however, the extruding apparatus 10 is arranged completely separately from and/or next to the first container 12. The threaded rod 20 is screwed into the adapter unit 26. The kit 1 further comprises a vacuum hose 50, a knee pressurizer 52, a hip pressurizer 53, a knee snorkel 54 and a flat snorkel 55.

[0108] FIG. 5 shows an embodiment of the first container 12, an apparatus 85 for storing and opening the second container 70, and an extruding apparatus 10, for example according to FIG. 3 as described above. The apparatus 85 contains the second container 70 which is designed as an ampoule 83 with a second component 82, namely a monomer liquid. The first component 81 is a bone cement powder which is located in the first container. The apparatus 85 comprises a buckling region 87 at which the apparatus 85 can be buckled in order to break off the head 84 of the ampoule 83. The head 84 and any glass fragments are then retained by a sieve, and the liquid can flow into the second container via the collection volume 86, if applicable a filter element, the tube element 57, and if applicable a further filter element. This can be done by gravity and/or by a vacuum. To apply a vacuum, the first container 12 comprises a nozzle (not shown here; see FIG. 15A) which opens into a vacuum chamber 58. This is connected to the interior of the first container 12 by means of a mesh or sieve. If a vacuum is applied, the liquid is sucked into the interior through the tube element 57.

[0109] In the embodiment shown here, the adapter unit 26 of the extruding apparatus comprises a support surface 60. The adapter unit can thus be used to hold the first container 12. For example, the opening of the ampoule 83 and the transfer of the liquid into the first container 12, for example at least partially due to gravity, can take place when the first container 12 is in the standing state by means of the support surface 60. The adapter unit 26 comprises an internal thread 28 for screwing in the threaded rod 20 of the extruding apparatus 10 shown in FIG. 6.

[0110] On the opposite side of the first container 12, an adapter unit 25 of the mixing apparatus 74 is arranged. The mixing apparatus 74 further comprises a rod 76 which passes through the adapter unit 25 and connects a mixing element 75 to a handle 24.

[0111] FIG. 5 shows a release mechanism of the mixing apparatus 74. If an actuating element on the handle 24 is actuated in a suitable manner, in particular in the fully pulled-out state, the handle 24 can be released from the rod 76. The rod 76 is designed in this case as a hollow rod. After the handle is released, the rod 76 can be used as a discharge tube for discharging the bone cement. The mixing element 75 remains inside the first container 12, for example in the region of the end face shown on the left, and in particular in a fixed state. This state is also shown in FIG. 12.

[0112] An alternative embodiment of the apparatus 85 for storing and opening the second container 70 is shown in FIGS. 7 and 8. The apparatus 85 comprises an inner shell 90 in which the ampoule 83 is arranged and an outer shell 89 which at least partially surrounds the inner shell 90. The inner shell 90 is axially displaceable with respect to the outer shell 89, at least in the direction of the first container, for example in the manner of a telescope, but can be held by a securing device 91, for example in the form of a removable securing clip. If the securing device 91 is inserted, the movement of the inner shell 90 is blocked. If the securing device is removed, the inner shell 90 can be moved towards the first container. The apparatus 85 further comprises a shearing element 88 for shearing off the head 84 of the ampoule 73. The shearing element typically includes a surface oriented obliquely to the longitudinal extension of the ampoule 83. If the inner shell 90 with the ampoule 83 is pushed towards the first container 12, the head 84 contacts the shearing element 88 and is thereby sheared off.

[0113] FIG. 8 shows how, in the embodiment described above or in a similar embodiment, the apparatus 85 comprises an outer shell 89 and an inner shell 90 movable relative to the outer shell 89 and can be used to pump the liquid into the first container 12. By pulling out the inner shell 90, as shown in FIG. 8, the volume in the apparatus 85 is increased, and air flows into the apparatus 85, for example through a suitable valve in a cover of the apparatus 85. When subsequently pushed in, the air displaces the liquid in the apparatus 85, for example in the collection volume 86, which has previously flowed out of the ampoule 83, and presses it into the first container. In this way, a vacuum source can be dispensed with, and the kit can be used for cementing without any additional apparatus.

[0114] FIG. 9 shows the separation of the apparatus 85 from the first container 12. At least one holding part 92, which has previously established a connection, can be removed. It is then possible to more easily mix and/or extrude the bone cement. The separation can be irreversible. A closure element, for example a gate valve, can close the opening in the first container 12 through which the tube element 57 previously protruded.

[0115] FIG. 10 shows an embodiment in which the mixing apparatus 74 is connected to the first container, and the extruding apparatus 10 and in particular a discharge tube 51 are provided separately therefrom. The mixing apparatus 74 comprises an adapter unit 25, and the extruding apparatus 10 comprises an adapter unit 26. Both adapter units can be attached on the same side of the first container 12. The discharge tube 51 can be attached to the other side of the first container 12.

[0116] FIG. 11 shows another embodiment in which the adapter unit 25 for the mixing apparatus 74 and the adapter unit 26 for the discharge device are arranged on opposite sides of the apparatus. FIG. 12 shows the extrusion of the bone cement 15 by means of the extruding apparatus 10 through the discharge tube 51.

[0117] FIGS. 13 and 14 show a sectional drawing of an extruding apparatus 10 along the central longitudinal axis. The extruding apparatus 10 comprises an adapter unit 26 with a connecting region 37 for mechanically connecting to a first container. In the embodiment shown here, the connecting region 37 can be plugged and/or screwed onto a corresponding region of a first container. In the embodiment shown here, the adapter unit 26 has connecting elements 29 for producing a bayonet connection. The direction of rotation for fastening the bayonet connection corresponds to the direction of rotation for screwing in the threaded rod 20.

[0118] The extruding apparatus 10 further comprises a threaded rod 20 with an external thread 22. The threaded rod 20 is passed through the passage opening 27 so that the external thread 22 engages with the internal thread 28 located in the passage opening 27. The manually operated handle 24 for rotating is located on the end of the threaded rod 20 shown at the right. When the threaded rod 20 is rotated, the threaded rod moves axially through the adapter unit 26 so that the bone cement can be pressed out.

[0119] On the end of the threaded rod 20 remote from the handle 24, the threaded rod 20 is designed to exert a pressure or a force on the bone cement. For this purpose, a pressure element 30 may be present. The pressure element 30 serves to directly or indirectly exert pressure on bone cement in order to press it out of a first container. For example, the pressure element 30 can move a plunger of the first container, which in turn presses the bone cement out of the first container. The pressure element 30 is discussed in detail below.

[0120] The threaded rod 20 can have an inner core, in the example shown here a metal rod 40, and/or a casing, in the example shown here a plastic casing 41. The metal rod 40 runs centrally inside the threaded rod 20 and contributes significantly to the mechanical stability of the threaded rod 20. The plastic casing 41 forms the external thread 22 and protects the metal rod 40 from external influences. The metal rod 40 is preferably not rotationally symmetrical, in order to ensure a connection to the handle 24 and/or the casing for conjoint rotation.

[0121] For example, the metal rod 40 can be hexagonal or square. In particular, a metal rod 40 with or made of stainless steel such as 316L is used. In particular, the metal rod 40 is completely encased with a plastic material. In particular, the thread is made of plastic. This provides a particularly smooth thread. The metal rod 40 is protected from external influences. In one embodiment, the metal rod 40 has a diameter of at least 7 mm and/or at most 10 mm, preferably about or exactly 8 mm.

[0122] In one embodiment, the threaded rod 20 has a length L of at least 15 cm and/or at most 23 cm. The length of the threaded rod 20 is in particular at least 17 cm, preferably at least 19 cm and/or at most 23 cm, preferably at most 21 cm. The length L is measured between the outermost regions where the external thread 22 is present. In addition, the outer diameter D.sub.A of the threaded rod 20 is shown, which is measured in the radial direction between the peaks of the external thread 22. The outer diameter D.sub.A in the example shown here is between 13.5 mm and 15 mm.

[0123] In one embodiment, the adapter unit comprises a connecting region for plugging onto a first container. In one embodiment, the connecting region has an inner diameter of at least 3.3 cm and/or at most 4.0 cm. In one embodiment, the threaded rod contains no metal parts other than the metal rod.

[0124] In FIG. 13, a completely unscrewed position of the threaded rod 20 from the adapter unit 26 is shown. In contrast, FIG. 14 shows a position in which the threaded rod 20 has already been partially rotated through the adapter unit 26, as occurs when pressing out bone cement.

[0125] In one embodiment, the adapter unit 26 comprises a recess 35 into which the pressure element 30 can be completely received. In this way, the connecting region 37 of the adapter unit 26 shown on the left side remains free of the pressure element 30. The connecting region 37 can thus be slipped over the associated end of the first container or plugged or screwed onto it without disturbing the pressure element 30.

[0126] The pressure element 30 can be constructed in two parts, as shown in FIGS. 13 and 14. A first part 31 in this case can be tightly connected to the threaded rod 20 so that it rotates together with the threaded rod 20 when the same rotates. A second part 32 can be rotatably connected to the first part 31 so that the second part 32 does not rotate when the threaded rod 20 is rotated. In this way, no rotational movement, but only an axial pressure force, is exerted on the bone cement 15 and/or on the plunger. The contacting surfaces of the first part 31 and of the second part 32 are preferably flat and smooth to enable smooth rotation.

[0127] In the example shown here, the second part 32 of the pressure element 30 surrounds the first part 31 of the pressure element 30 and/or forms an undercut 34 therewith. On the right-hand side, the circumferential outer rim of the second part 32 extends inwards and engages behind the radially outer edge of the first part 31. The first part 31 and/or the second part 32 can be designed in the form of a plate. The second part 32 may have a diameter of at least 20 mm and/or at most 30 mm, for example approximately or exactly 25 mm.

[0128] Different embodiments of the pressure element 30 are shown in FIGS. 15A to 15C. In principle, the pressure element 30 presses on the bone cement to press it out. In particular, this is done indirectly, with the pressure element 30 pressing on a plunger 13 which in turn is in contact with the bone cement. In FIG. 15A, the pressure element 30 comprises only a first part 31 which is fixedly or rotatably connected to the threaded rod 20. The structure is particularly simple. However, the plunger 13 may also rotate, which increases the friction and thus the force required for extruding. FIG. 15B shows a two-part construction of the pressure element 30. Between the first part 31 and the plunger 13, there is a second part 32 of the pressure element 32 which is arranged rotatably with respect to the first part 31. The second part 32 extends over almost the entire inner diameter of the corresponding region of the plunger, wherein advantageously at least a slight distance should remain between the inner peripheral surface of the plunger 13 and the second part 32 so that no friction occurs here. The second part 32 may be a flat disk. In particular, there is a lubricant, such as silicone, between the two parts 31, 32 to enable smooth rotation. The first part 31 can be connected to the threaded rod 20 in a rotationally fixed manner. There is a rotation between the first part 31 and the second part 32, but no rotation between the second part 32 and the plunger 13. This reduces friction and therefore the required force. FIG. 15C shows a further embodiment in which the first part 31 is designed as a flat disk which is located in a recess of the second part 32. The threaded rod only rotates the flat first part 31, and the second part 32 does not rotate with the plunger 13. The parts 31, 32 transmit the force of the extruding apparatus evenly and prevent the plunger 13 from tilting.

[0129] FIG. 16 is an enlarged section through a threaded rod 20. This comprises an internal metal rod 40 and a plastic casing 41 which completely encloses the metal rod 40. The outer diameter DA of the threaded rod 20 is shown, which corresponds to the maximum diameter between the peaks on both sides of the external thread 22. In addition, the inner diameter DI of the threaded rod 20 is shown, which corresponds to the minimum diameter between the depressions or valleys on both sides of the external thread 22. The thread has a thread depth between 1 mm and 2 mm. The difference between the inner diameter D.sub.I and the outer diameter D.sub.A is therefore between 2 mm and 4 mm.

[0130] A thread turn 66 is delimited by dashed lines by way of example. The thread turn corresponds to a complete rotation of the external thread 22 in relation to the corresponding internal thread. The threaded rod 20 can be designed such that an outer surface of a thread turn 66 of the external thread 22 is at most 370 mm.sup.2. In the example of a trapezoidal thread shown here, the outer surface of the thread is determined as the sum of the upper surface 61, which corresponds to the surface in the region of the thread peak, the lower surface 62, which corresponds to the surface in the region of the thread depression, the first (ascending) flank surface 63 and the second (descending) flank surface 64.

[0131] In one embodiment, an outer surface of a thread turn of the external thread is at most 450 mm.sup.2, at most 430 mm.sup.2, at most 400 mm.sup.2, at most 370 mm.sup.2, at most 350 mm.sup.2, at most 330 mm.sup.2, or at most 300 mm.sup.2. In one embodiment, an outer surface of a thread turn of the external thread is at least 100 mm.sup.2, at least 130 mm.sup.2, at least 160 mm.sup.2, at least 180 mm.sup.2, at least 200 mm.sup.2, at least 215 mm.sup.2, at least 250 mm.sup.2, at least 280 mm.sup.2, at least 320 mm.sup.2, or at least 350 mm.sup.2. These values may be particularly suitable depending on the design and materials.

[0132] In an example, the threaded rod has an outer diameter D.sub.A of 14 mm, a thread depth (tooth height) of 1.5 mm and a pitch of 4.5 mm. These values represent a good compromise between advancement per rotation and the force required to turn. In addition, this threaded rod 20 has a suitable self-locking mechanism, so that it has no tendency to turn back during the extruding.

[0133] FIGS. 17A to 17B show the use of a holder 80 in the packaging means 77. An adapter unit 26, in particular an extruding apparatus 10, is connected to the first container 12 on its side facing away from the apparatus 85. The adapter unit 26 comprises a support surface 60. The support surface 60 corresponds to the holder 80 which is arranged or formed on the inside of the packaging means 77, for example by deep drawing. Both the support surface 60 and the holder 80 are designed as three-dimensional structures that ensure good interlocking and thus a stable hold. If, however, the adapter unit 26 is contrastingly designed as a hollow cylinder, standing on a flat surface is possible.

[0134] FIG. 17A shows the state shortly before standing the first container 12 on the support surface 80. FIG. 17B shows the standing state. The apparatus for storing and opening the second container is connected the second container 70, and the mixing apparatus is connected to the first container. In FIG. 17C, the mentioned apparatuses are removed. Now the mixing can begin. Due to the firm and secure standing of the first container 12, this can be done particularly easily and safely.

List of Reference Numerals

[0135] Kit 1 [0136] Extruding apparatus 10 [0137] Pumping device 11 [0138] First container 12 [0139] Plunger 13 [0140] Bone cement 15 [0141] Threaded rod 20 [0142] External thread 22 [0143] Handle 24 [0144] Adapter unit 25 [0145] Adapter unit 26 [0146] Passage opening 27 [0147] Internal thread 28 [0148] Connecting element 29 [0149] Pressure element 30 [0150] First part 31 [0151] Second part 32 [0152] Undercut 34 [0153] Recess 35 [0154] Connecting region 37 [0155] Metal rod 40 [0156] Plastic casing 41 [0157] Vacuum hose 50 [0158] Discharge tube 51 [0159] Knee pressurizer 52 [0160] Hip pressurizer 53 [0161] Knee snorkel 54 [0162] Flat snorkel 55 [0163] Tube element 57

[0164] Vacuum chamber 58

[0165] Nozzle 59 [0166] Support surface 60 [0167] Upper surface 61 [0168] Lower surface 62 [0169] First flank surface 63 [0170] Second flank surface 64 [0171] Thread turn 66 [0172] Second container 70 [0173] Mixing apparatus 74 [0174] Mixing element 75 [0175] Rod 76 [0176] Packaging means 77 [0177] Shell 78 [0178] Cover 79 [0179] Holder 80 [0180] First component 81 [0181] Second component 82 [0182] Ampoule 83 [0183] Head 84 [0184] Apparatus 85 [0185] Collection volume 86 [0186] Buckling region 87 [0187] Shearing element 88 [0188] Outer shell 89 [0189] Inner shell 90 [0190] Securing device 91 [0191] Holding part 92 [0192] Inner diameter D [0193] Inner diameter D.sub.I [0194] Outer diameter D.sub.A [0195] Length L [0196] Axial extension A [0197] Axial extension B1