Device for Producing a Hardenable Mass

• US 20070217282A1
• Filed: 06/17/2005
• Published: 09/20/2007
• Est. Priority Date: 06/22/2004
• Status: Active Grant

• Current Assignee: Bonesupport Nya AB, BONE Support NYA AB, Dimonex Ltd.
• Original Assignee: Bone Support AB (BONESUPPORT HOLDING AB), Teg Holdings S.A.
• Inventors: Lidgren, Lars, Brorsson, Fritz, Lundgren, Torgny, Jonsson, Sven, Gullwi, Osten
• Granted Patent: US 7,938,572 B2
• Time in Patent Office: Days
• US Class Current: 366/108
• 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 17/8827 with filtering, degassing, venting or pressure relief means
• 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: A61F 2002/4685 by means of vacuum
• CPC Class Codes: A61M 5/31596 comprising means for injection of two or more media, e.g. by mixing
• CPC Class Codes: B01F 2101/20 Mixing of ingredients for bone cement
• CPC Class Codes: B01F 31/441 performing a rectilinear reciprocating movement
• CPC Class Codes: B01F 33/50112 of the syringe or cartridge type
• CPC Class Codes: B01F 33/70 Mixers specially adapted for working at sub- or super-atmospheric pressure, e.g. combined with de-foaming
• CPC Class Codes: B01F 35/754251 reciprocating in the mixing receptacle
• CPC Class Codes: B29B 7/005 for mixing in batches
• CPC Class Codes: B29B 7/26 for discharging, e.g. doors

Abstract

The present invention relates to a device for producing a hardenable mass, preferably bone substitute and/or bone reinforcing material or bone cement or similar material. A mixing container (3) has a mixing space (4) in which at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2). A piston means (7) is provided in the mixing space (4) of the mixing container (3). At least one means (8) which is rotatable relative to the mixing container (3) cooperates with the piston means (7) for, in a retaining position (P1), retaining said piston means (7) relative to the mixing container (3) and, by rotation to a release position (P2), releasing the piston means (7) such that said piston means can move in a direction (U) towards at least one opening (49) through which said mass (2) can pass out of the mixing space (4). The rotatable means (8) is provided such that it in its release position (P2) can follow the piston means (7) in the mixing space (4) in the direction (U) towards said opening (49).

Claims

1. :

Device for producing a hardenable mass, preferably bone substitute and/or bone reinforcing material or bone cement or similar material, wherein;

a mixing container (3) has a mixing space (4) in which at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2),

a piston means (7) is provided in the mixing space (4) of the mixing container (3), and

at least one means (8) which is rotatable relative to the mixing container (3) co-operates with the piston means (7) for, in a retaining position (P1), retaining said piston means (7) relative to the mixing container (3) and, by rotation to a release position (P2), releasing the piston means (7) such that said piston means can move in a direction (U) towards at least one opening (49) through which said mass (2) can pass out of the mixing space (4),

the rotatable means (8) is provided such that it in its release position (P2) can follow 15 the piston means (7) in the mixing space (4) in the direction (U) towards said opening (49).

2. :

Device according to claim 1, wherein;

the rotatable means (8) comprises a first member (36) which can be brought to cooperate with a second and a third member (31a, 31b) which are immovably provided relative to the mixing container (3) such that the first member (36) of the rotatable means (8) co-operates with the second member (31a) of the mixing container (3) when said rotatable means (8) is situated in its retaining position (P1) for preventing the rotatable means (8) and the piston means (7) from moving in the direction (U) towards the opening (49), and

the first member (36) of the rotatable means (8) can be rotated out of cooperation with said second member (31a) and into cooperation with said third member (31b) by rotating the rotatable means (8) to its release position (P2) for permitting the rotatable means (8) and the piston means (7) to move in the direction (U) towards said opening (49).

3. :

Device according to claim 2, wherein;

the first member of the rotatable means (8) is a first flange (36) which in relation to said direction (U) is directed radially outwards from the rotatable means (8) and which extends around a part of the periphery of the rotatable means (8),

said second member is a second flange (31a) which in relation to said direction (U) is directed radially into a hole (28) through which the rotatable means (8) is adapted to pass when it is set in its release position (P2), and which extends along a part of the periphery of the hole (28), and

said third member is such a section (31b) of the periphery of the hole (28) which lacks the second flange (31a) and through which section (31b) the first flange (36) of the rotatable means (8) can pass.

4. :

Device according to claim 2, wherein the second and third members (31a, 31b) are provided on a bracket (25) which can be located on the mixing container (3).

5. :

Device according to claim 4, wherein the bracket (25) can be attached to the mixing container (3) by a snap-on closure.

6. :

Device according to claim 4, wherein a rotary-movement preventing member (19) is provided to prevent rotation of the piston means (7) relative to the bracket (25) when the rotatable means (8) is rotated relative to the piston means (7).

7. :

Device according to claim 6, wherein;

the rotary-movement preventing member (19) is located on the piston means (7), and

the rotary-movement preventing member (19) is provided to cooperate with the bracket (25) such that said bracket prevents rotation of the rotary-movement preventing member (19) and thereby, the piston means (7), relative to the bracket (25) when the rotatable means (8) is rotated relative to the piston means (7).

8. :

Device according to claim 1, wherein a rotary stop (32) is provided to limit the rotary movement of the rotatable means (8).

9. :

Device according to claim 1, wherein the rotatable means (8) has a through hole (8a) for an elongated member (10) of a mixing means (9) which is provided for mixing the powder and liquid components (5, 6) in the mixing space (4).

10. :

Device according to claim 9, wherein;

the rotatable means (8) cooperates with a coupling device (37) which is located between said rotatable means (8) and the piston means (7) for interconnection of the piston means (7) arid the elongated member (10) of the mixing means (9), and

the piston means (7), after connection thereof to the elongated member (10) of the mixing means (9), is displaceable in a direction (U) by means of said mixing means (9) for discharge of mixed mass (2) from the mixing space (4).

11. :

Device according to claim 10, wherein;

the coupling device (37) comprises a coupling means (38) which cooperates with a support member (39) on the piston means (7), said support member (39) being located on one side of the elongated member (10) of the mixing means (9),

the rotatable means (8) comprises a resilient element (42) which is located on the same side of the elongated member (10) when the rotatable means (8) is set in its retaining position (P1) such that the resilient element (42), by holding the coupling means (38) against the support member (39), brings the coupling means (38) to its neutral position (P3), and

the rotatable means (8), by rotation thereof to its release position (P2), moves the resilient element (42) to an opposite side of the elongated member (10) and brings thereby the coupling means (38) to its coupling position (P4) in which it is clamped or fastened to the elongated member (10).

12. :

Device according to claim 10, wherein the coupling device (37) is provided to release the mixing means (9) from the piston means (7) when the mixing means (9) is pulled in a direction (R) relative to the piston means (7) which is opposite to the direction (U) towards the opening (49).

13. :

Device according to claim 9, wherein the elongated member (10) of the mixing means (9) comprises an outer member (45) which is located outside the mixing container (3) and is designed to be brought in contact therewith for preventing it from coming in contact with the rotatable means (8) in order to avoid rotation of said rotatable means (8) by the mixing means (9) when said mixing means (9) is rotated during mixing of the powder and liquid components (5, 6).

14. :

Device according to claim 1, wherein at least one opening (17, 47 or 48) is provided to release or let out gases from the mixing space (4).

15. :

Device according to claim 14, wherein the opening (17) is provided in the piston means (7).

16. :

Device according to claim 14, wherein the opening (47) is located in one side of the mixing container (3) adjacent the piston means (7) when said piston means (7) is retained by the bracket (25) such that the opening (47) is closed by the piston means (7) when the piston means (7) is brought to move in a direction (U).

17. :

Device according to claim 14, wherein the opening (17) has a filter (18) which prevents the powder and/or liquid component (5 and/or 6) and/or mass (2) mixed thereof from passing out through said opening (17).

18. :

Device according to claim 1, wherein at least one opening (48) is provided in one side of the mixing container (3) about half the way between the piston means (7), when said piston means (7) is retained by the rotatable means (8), and the opening (49) through which mixed mass (2) can pass out of the mixing container (3), and that said first opening (48) is closable.

19. :

Device according to claim 1, wherein a vacuum generating device (50) is provided to generate a vacuum in the mixing space (4).

20. :

Device according to claim 19, wherein the vacuum generating device (50) is brought to generate a vacuum in the mixing space (4) in order to accelerate suction of the liquid component (6) into said mixing space (4).

21. :

Device according to claim 1, wherein a screw device (51) is provided to impart, by means of screw movements, a discharge movement to the piston means (7) in a direction (U) for discharge of mixed mass (2) from the mixing space (4).

22. :

Device according to claim 21, wherein;

the screw device (51) includes a nut-like member (52) which can be located on the mixing container (3) such that said screw device (51) is non-rotatable relative to the mixing container (3),

the screw device (51) further includes a screw-like member (55) which can be screwed into the nut-like member (52) and which can be located on an operating handle (13) or similar forming part of the mixing means (9) such that the operating handle (13) and the screw-like member (55) are non-rotatably connected to each other, and

the screw-like member (55) can move the piston means (7) in a direction (U) by screwing said screw-like member (55) into the nut-like member (52) by means of the operating handle (13).

23. :

Device according to claim 1, wherein the piston means (7) is designed as a part of a screw for discharge of mixed mass (2) from the mixing space (4).

24. :

Device according to claim 1, wherein the piston means (7) is provided to be operated in one direction (U) for discharge of mixed mass (2) from the mixing space (4) either

a) by moving the piston means (7) in a direction (U) by manually subjecting an operating handle (13) or similar to a linear discharge force, or

b) by moving the piston means (7) in the direction (U) by manually imparting screw movements to the operating handle (13) which can be transferred to the piston means (7) by a screw device (51), or

c) by positioning the device (1) in a gun-like discharge device (62) which can be operated stepwise for generating discharge forces which are transferred to the piston means (7) for movement thereof in the direction (U).

25. :

Device according to claim 1, wherein;

the mixing space (4) of the mixing container (3) is sealed and includes the powder component (5), and

the liquid component (6) can be fed into the mixing space (4) when mixing of the powder and liquid components (5, 6) shall occur.

26. :

Device according to claim 25, wherein;

a discharge opening (49) for discharge of mixed mass (2) from the mixing space (4) is closed by a closing device (64),

the liquid component (6) is located in a liquid container (65) with a discharge end (66) through which the liquid component (6) can be discharged or fed out of the liquid container (65), and

the closing device (64) is provided to be opened by means of the discharge end (66) of the liquid container (65) when said end (66) is inserted into the closing device (64) such that the liquid component (6) can be fed into the mixing space (4), and that the closing device (64) is provided to once again close when the discharge end (66) of the liquid container (65) is removed or withdrawn from the closing device (64).

27. :

Device according to claim 26, wherein a valve (67) is provided to cooperate with the closing device (64) to allow gas to escape from or pass out of the mixing space (4) when the liquid component (6) is fed thereinto from the liquid container (65).

28. :

Device according to claim 1, wherein the mixing container (3) is provided to be brought to cooperate with a vibrating device (68) for vibrating the powder and liquid components (5, 6) and/or the mass (2) in the mixing space (4).

29. :

Device according to claim 1, wherein;

the mixing container (3) can be connected to a distributor device (69) or vice versa, that several containers (70) can be connected to the distributor device (69) or vice versa,

mass (2) mixed in the mixing space (4) of the mixing container (3) can be discharged to the distributor device (69), which is provided to distribute the mass (2) to spaces (71) in the containers (70) such that each space (71) in every container (70) is filled with a part volume (2a) of the mass (2), and

each part volume (2a) of the mass (2) can be sucked and/or fed out of the spaces (71) of the containers (70) after removal of the containers (70) from the distributor device (69).

30. :

Device according to claim 29, wherein;

a front part (84) of each container (70) can be connected to the distributor device (69) or vice versa such that a part volume (2a) of the mass (2) can be fed into the space (71) of the container (70), and

a cannula or needle (83) can be located at the front part (84) or vice versa after the space (71) of the container (70) has been provided with a part volume (2a) of mass (2), through which cannula (83) said part volume (2a) of mass (2) can be sucked and/or fed out of said space (71).

31. :

Device according to claim 30, wherein a piston (86) in each container (70) can be set in a rear part (85) of the container (70) when a part volume (2a) of the mass (2) is fed into the space (71) of the container (70).

32. :

Device according to claim 29, wherein a rear part (85) of the container (70) has an opening (87) which is located in front of a piston (86) when said piston is situated in said rear part (85) and which permits gas present in the space (71) of the container (70) to flow out of said space (71) through said opening (87) when said space (71) is filled with a part volume (2a) of mass (2).

33. :

Device according to claim 29, wherein one container (70) at the time can be removed from the distributor device (69) for emptying thereof, while the other containers (70) remain attached thereto.

34. :

Device according to claim 1, wherein;

the mixing container (3) can be brought to cooperate with inner parts (89a) of spongy bone (89) in such a way that its mixing space (4) communicates with said inner parts (89a), and

at least one vacuum source (90) is provided to generate a vacuum in the inner parts (89a) of the spongy bone (89) for sucking mixed mass (2) from the mixing space (4) into said inner parts (89a).

35. :

Device according to claim 34, wherein a piston means (7) is provided for discharge of mass (2) from the mixing space (4) while at the same time mass (2) is sucked out of said space (4).

36. :

Device according to claim 29, wherein;

the container (70) with the part volume (2a) of mass (2) can be brought to cooperate with inner parts (89a) of spongy bone (89) in such a manner that the space (71) in the container (70) communicates with said inner parts (89a), and

at least one vacuum source (90) is provided to generate a vacuum in the inner parts (89a) of the spongy bone (89) for sucking out a part volume (2a) of mass (2) from the space (71) into said inner parts (89a).

37. :

Device according to claim 36, wherein a piston (86) is provided to discharge a part volume (2a) of mass (2) from the space (71) while at the same time mass (2) is sucked out of said space (71).

38. :

Use of the device according to claim 34, wherein the spongy bone (89) is a spongy vertebra.

39. :

Use of the device according to claim 34, wherein the spongy bone (89) is an osteoporosis fracture in the form of a thighbone (femoral) or knee (patellar) fracture.

40. :

Device according to claim 1, wherein the piston means (7) is provided to discharge mixed mass (2) for fixation of bone implants.

41. :

Device according to claim 1, wherein the mass (2) is a bone substitute and/or bone reinforcing material including a component of a calcium base material or substantially calcium base material or ceramic or substantially ceramic material.

42. :

Device according to claim 41, wherein the calcium base material or the ceramic material is a hardenable mineral or a ceramic which can be brought to harden in the spongy bone (89).

43. :

Device according to claim 42, wherein the calcium base material or ceramic can be brought to harden by mixing with a hardener such as water.

44. :

Device according to claim 42, wherein the calcium base material or ceramic is selected from the group comprising calcium sulphate-α

-hemihydrate, calcium sulphate-β

-hemihydrate, calcium sulphate-dihydrate, calcium carbonate, α

-tricalcium phosphate, hydroxyapatite, dicalcium phosphate-dihydrate, anhydrous dicalcium phosphate, tetracalcium phosphate, β

-tricalcium phosphate, calcium deficient hydroxyapatite, monocalcium phosphate-monohydrate, monocalcium phosphate, calcium-pyurophosphate, precipitated hydroxyapatite, carbonaceous apatite (dahlite), octacalcium phosphate, amorphous calcium phosphate, oxyapatite, carbonate apatite and calcium aluminate.

45. :

Device according to claim 41, wherein an X-ray contrast agent is mixed into the ceramic material.

46. :

Device according to claim 45, wherein the X-ray contrast agent is water soluble and non-ionic.

47. :

Device according to claim 45, wherein the water soluble non-ionic X-ray contrast agent is selected from the group comprising iohexol, ioversol, iopamidol, iotrolan, metrizamide, iodecimol, ioglucol, ioglucamide, ioglunide, iogulamide, iomeprol, iopentol, iopromide, iosarcol, iosimide, iotusal, ioxilan, iofrotal and iodecol.

48. :

Device according to claim 1, wherein the mass (2) is a bone cement comprising the components polymer, preferably of polymethylmethacrylate(PMMA)-type, and monomer, preferably of methylmethacrylate(MMA)-type, which components harden when mixed with each other.

49. :

Device according to claim 41, wherein the bone substitute and/or bone reinforcing material or the bone cement consists of a mineral and/or a ceramic in combination with polymer material.

50. :

Device for producing a hardenable mass, preferably bone substitute and/or bone reinforcing material or bone cement or similar material, wherein;

a mixing container (3) has a mixing space (4) in which at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2),

a piston means (7) is provided in the mixing space (4) of the mixing container (3),

at least one means (8) which is rotatable relative to the mixing container (3) co-operates with the piston means (7) for, in a retaining position (P1), retaining said piston means (7) relative to the mixing container (3) and, by rotation to a release position (P2), releasing the piston means (7) such that said piston means can move in a direction (U) to-wards the opening (49), and

a screw device (51) can be connected to the mixing container (3) such that said screw device can impart, by means of screw movements, a discharge movement to the piston means (7) in a direction (U) for discharge of mixed mass (2) from the mixing space (4),

the screw device (51) includes a nut-like member (52) which can be located on the mixing container (3) such that said screw device (51) is non-rotatable relative to the mixing container (3),

the screw device (51) further includes a screw-like member (55) which can be screwed into the nut-like member (52) and which can be located on an operating handle (13) or similar forming part of the mixing means (9) such that the operating handle (13) and the screw-like member (55) are non-rotatably connected to each other, and

the screw-like member (55) can move the piston means (7) in a direction (U) by screwing said screw-like member (55) into the nut-like member (52) by means of the operating handle (13).

51. :

Device for producing a hardenable mass, preferably bone substitute and/or bone reinforcing material or bone cement or similar material, wherein;

a mixing container (3) has a mixing space (4) in which at least one powder and at least one liquid component (5, 6) are mixed to provide the hardenable mass (2),

a piston means (7) is provided in the mixing space (4) of the mixing container (3), and

at least one means (8) which is rotatable relative to the mixing container (3) co-operates with the piston means (7) for, in a retaining position (P1), retaining said piston means (7) relative to the mixing container (3) and, by rotation to a release position (P2), releasing the piston means (7) such that said piston means can move in a direction (U) towards the opening (49),

the mixing container (3) can be connected to a distributor device (69) or vice versa,

several containers (70) can be connected to the distributor device (69) or vice versa,

mass (2) mixed in the mixing space (4) of the mixing container (3) can be discharged to the distributor device (69), which is provided to distribute the mass (2) to spaces (71) in the containers (70) such that each space (71) in every container (70) is filled with a part volume (2a) of the mass (2), and

each part volume (2a) of the mass (2) can be sucked and/or fed out of the spaces (71) of the containers (70) after removal of the containers (70) from the distributor device (69).

52. :

Device according to claim 51, wherein;

a front part (84) of each container (70) can be connected to the distributor device (69) or vice versa such that a part volume (2a) of the mass (2) can be fed into the space (71) of the container (70), and

a cannula or needle (83) can be located at the front part (84) or vice versa after the space (71) of the container (70) has been provided with a part volume (2a) of mass (2), through which cannula (83) said part volume (2a) of mass (2) can be sucked or fed out of said space (71).

53. :

Device according to claim 52, wherein a piston (86) in each container (70) can be set in a rear part (85) of the container (70) when a part volume (2a) of the mass (2) is fed into the space (71) of the container (70).

54. :

Device according to claim 51, wherein a rear part (85) of the container (70) has an opening (87) which is located in front of a piston (86) when said piston is situated in said rear part (85) and which permits gas present in the space (71) of the container (70) to flow out of said space (71) through said opening (87) when said space (71) is filled with a part volume (2a) of mass (2).

55. :

Device according to claim 51, wherein one container (70) at the time can be removed from the distributor device (69) for emptying thereof, while the other containers (70) remain attached thereto.

56. :

Device for receiving and distributing of a hardenable mass, preferably bone substitute and/or bone reinforcing material or bone cement or similar material, wherein;

a container (70) is provided with a movable piston (86) for distributing the hardenable mass (2) out from a space (71) of the container (70), and

a rear part (85) of the container (70) has an opening (87) which is located in front of a piston (86) when said piston is situated in said rear part (85) and which opening (87) permits gas present in the space (71) of the container (70) to flow out of said space (71) through said opening (87) when said space (71) is filled with said mass (2).