JP2001218774A - Kneading instrument for calcium phosphate based cement and preparation method for calcium phosphate based cement using the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a kneading instrument for calcium phosphate based cement for easily kneading and filling the calcium phosphate based cement and preventing foreign matter or the like from being mixed in and the preparation method of the calcium phosphate based cement using it. SOLUTION: This instrument is provided with a cylinder 1 provided with a cylinder base part 11 and a nozzle part 12 provided on one end side of it, a partition tool 2 provided slidably inside the cylinder base part, a piston 3 provided with a shaft part 31 vertically movably and rotatably provided through the partition tool, a kneading part 32 provided on one end of it and a handle part 33 provided on the other end, a hardening liquid supply means 4 provided inside the piston, a lid 5 provided on the tip of the nozzle part and a stopper 6 for fixing the partition tool to the other end side of the cylinder base part. The hardening liquid supply means is formed by utilizing a space part 44 provided inside the piston and the small-sized and light-weight kneading instrument in a simple structure is attained.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a kneading method for calcium phosphate cement used for kneading calcium phosphate powder for medical use with a kneading liquid such as pure water and filling or applying it to an application site such as a bone defect. The present invention relates to a device and a method for preparing a calcium phosphate cement using the device. In particular, the present invention is used by filling a defect or the like of a living bone caused by a fracture or osteoporosis, or by applying an artificial bone made of metal, ceramics, or the like as an adhesive for fixing the living bone to the living bone. The present invention relates to a kneading device for calcium phosphate cement and a method for preparing a calcium phosphate cement using the same.

[0002]

2. Description of the Related Art A calcium phosphate cement containing a calcium phosphate compound as a main component has the same composition as the inorganic components constituting tissues such as living bones and teeth, and therefore has high biocompatibility and is used in the medical field such as shaping or forming. Very useful in. Such calcium phosphate cement is usually
It is used as follows. First, a powder composed of a calcium phosphate compound and a kneading liquid such as pure water are mixed in a mortar or the like. Thereafter, these are kneaded, and the resulting cement is filled or applied to bone and tooth defects using a syringe, a spatula, or the like, and then cured to obtain a cured product.

However, it is not easy to uniformly knead a calcium phosphate-based powder and a kneading liquid such as pure water using a mortar or the like. In addition, filling cement into a syringe or the like requires a complicated operation, particularly depending on the viscosity. Furthermore, during the operation of kneading with a mortar or the like, or the operation of filling cement into a syringe or the like, there is a possibility that foreign matter and various bacteria may be mixed into the kneaded material. In any case, the operations such as kneading and filling are meticulous. Must be done with care.

[0004]

DISCLOSURE OF THE INVENTION The present invention solves the above-mentioned conventional problems. A calcium phosphate cement capable of easily preparing a calcium phosphate cement and having no foreign matter or germs mixed into the cement. It is intended to provide a kneading device. Also, the present invention
It is an object of the present invention to provide a method for preparing a calcium phosphate-based cement which can easily knead a calcium phosphate-based powder and a kneading liquid such as pure water using the kneading device and can form a homogeneous cement.

[0005]

According to a first aspect of the present invention, there is provided a kneading device for calcium phosphate cement, comprising: a cylinder having a cylindrical base and a nozzle provided at one end of the cylindrical base; A partition member 2 provided movably, a shaft portion 31 provided so as to be vertically movable and rotatable through the partition member, a kneading portion 32 provided at one end of the shaft portion, and provided at the other end of the shaft portion. A piston 3 having a handle portion 33 provided therein, a curing liquid supply means 4 provided in the piston, a lid 5 provided at the tip of the nozzle portion, and a stopper for fixing the partitioning tool to the other end side of the cylindrical base portion. 6 is provided.

[0006] A method for preparing a calcium phosphate cement according to a fourth invention is a method for preparing a calcium phosphate cement using the kneading device for a calcium phosphate cement according to any one of the first to third inventions, The calcium phosphate-based powder is put into the space formed by the cylindrical base 11 and the partitioning tool 2, and the curing liquid is put into the cylindrical part 411 or the cylindrical space 441 of the curing liquid supply means 4, respectively. The curing liquid is supplied into the space, and then the piston 3 is vertically moved and rotated in the cylinder 1 to knead the calcium phosphate-based powder and the kneading liquid.

[0007] In the calcium phosphate cement prepared as in the fourth invention, the piston 3 is moved to a position where the kneading section 32 comes into contact with the partitioning tool 2, the lid 5 and the stopper 6 are removed, and then the piston is connected to the nozzle. Part 12
Side, and the cement can be filled or applied to the application site by extruding the cement from the nozzle portion out of the cylinder.

The components constituting the kneading device for calcium phosphate cement, ie, the materials of the cylinder, the partition, the piston, the hardening liquid supply means, the lid and the stopper, do not alter the calcium phosphate powder and the kneading solution, and The resin is not particularly limited as long as it is not deteriorated by the component (a), and synthetic resins, hard rubbers, metals and the like can be used. Among these, a synthetic resin having excellent moldability such as hollow molding and integral molding, capable of forming a tubular body and a piston having a required shape with high dimensional accuracy, and having good chemical resistance and the like is particularly preferable. As such a synthetic resin,
Silicone resin, fluorine resin such as polytetrafluoroethylene, polystyrene, polycarbonate, polyethylene, polypropylene, polyamide, polyacetal, polyester, and the like can be used.

As the calcium phosphate-based powder, powders such as tetracalcium phosphate, calcium hydrogen phosphate, α-tricalcium phosphate and β-tricalcium phosphate can be used. One type of these powders may be used alone, or two or more types may be used in combination. Further, an X-ray contrast agent such as barium sulfate or bismuth subcarbonate can be added to the powder. Further, in order to shorten the curing time, hydroxyapatite or a fluoride thereof may be added as a seed crystal. As the kneading liquid, water such as pure water can be used. Further, an aqueous solution containing an appropriate amount of a polysaccharide such as dextran sulfate, an organic acid, an inorganic acid, or the like can also be used.

[0010]

DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in more detail by way of examples. (1) Structure of kneading device The specific structure of the kneading device used will be described with reference to FIGS. 1 shows the appearance of the kneading apparatus, FIG. 2 shows a cross section thereof, and FIG. 3 shows a cross section of the kneading liquid supply means. FIG. 4 shows a state before kneading, in which the piston is pulled up to the uppermost position, in which a calcium phosphate-based powder is contained in a space formed by the cylindrical base and the partitioning tool, and a curing liquid is contained in the curing liquid supply means. I have. This kneading device can be stored as it is until the time of kneading, with the powder and the curing liquid being contained. FIG. 5 shows a state where the kneaded material has been extruded.

The kneading apparatus actually used has a cylinder 1 having a length of about 90 mm and an outer diameter of about 25 mm.
A content of 0 ^-5 m ³ can be kneaded. The amount of cement that can be kneaded in the cylinder 1 is an amount necessary for one operation or an amount slightly more than this (for example, 1).
If the required amount of the batch is about 1 × 10 ⁻⁵ m ³ , 1 × 1
It is preferably about 0 ^{-5 to} 1.3 × 10 ^-5 m ³ ). If the amount is less than the required amount for one time, kneading needs to be performed many times. On the other hand, if the amount exceeds the required amount, unnecessary cement will be prepared, and excess cement will be discarded without being used, which is not preferable.

The nozzle portion 12 may have any shape as long as it can fill the cylinder 1 with calcium phosphate-based powder or discharge cement out of the cylinder. For example, by using the same luer lock shape as that used in commercially available syringes and the like, it is possible to easily attach and detach the injection needle, catheter, and the like that can be used in these syringes and the like. When the injection needle, the catheter, and the like are attached to the nozzle portion 12 in this manner, the cement can be easily and accurately filled or applied to an application site such as a bone defect.

The partitioning tool 2 is a substantially columnar body, is inserted from the opening of the cylinder 1, and is fixed by a stopper 6. A female screw is provided on the peripheral surface of the through hole at the center of the partitioning tool 2. Further, an insertion hole 21 for inserting the stopper 6 is provided on a side surface of the partitioning tool 2.
In addition, grooves 22 and 23 are provided over the entire circumference on the outer circumference of the partitioning tool 2 and on the inner circumference where the female screw is provided, and these grooves are provided with silicone rubber, styrene butadiene rubber, urethane rubber, and the like. O-rings 91 and 92 are fitted. In this way, O
By fitting the ring, it is possible to prevent leakage of cement and invasion of various germs, and to facilitate sliding of the partitioning tool 2 and rotation of the shaft portion 31.

The piston 3 comprises a shaft portion 31 and a kneading portion 3
2 and a handle portion 33, and the kneading portion 32 is provided with a stirring blade. The shaft portion 31 is a columnar body provided with external threads. This male screw is screwed with the female screw of the partitioning tool 2, and the shaft 3 is rotated to move the piston 3 up and down in the cylinder 1. In addition, the kneading section 32 provided at one end of the shaft section 31 can be moved up and down by rotation of the shaft section 31, and the stopper 6 is removed, and the shaft section 31 is moved up and down without rotating so that the partitioning tool can be moved. 2 can be moved up and down.

The kneading section 32 is provided at the tip of the shaft section 31. Further, the kneading unit 32 includes a plurality of stirring blades radially arranged from the center of the kneading unit 32. The stirring blade may be arranged at an angle to the center of the kneading unit 32. Further, although the extension of the stirring blade passes through the center of the kneading unit 32, the extension of the stirring blade may not be provided through the center of the kneading unit 32. Further, the stirring blade usually has a substantially wedge-shaped cross-sectional shape whose thickness becomes thinner toward the distal end side. The pitch of the external thread of the shaft portion 31 can be 5 to 25 mm, particularly preferably 6 to 20 mm, and more preferably 7 to 15 m. By setting the screw pitch in this range, a homogeneous cement can be easily prepared in a short time. The number of stirring blades can be about 2 to 6, especially 4 and can have various shapes and structures that can be kneaded efficiently.

The handle portion 33 is a disc-shaped body whose center is fixed to the other end of the shaft portion 31. The handle portion 33 may have a planar shape such as a rod shape, a cross shape, and a polygonal shape, and a projection 34 for easily rotating the piston 3 may be provided on an upper surface thereof.
The cement in the cylinder 1 can be extruded by pressing the upper surface of the handle 33 and moving the piston 3 and the partition 2 toward the nozzle 12 of the cylinder 1. Handle part 33, shaft part 31 and kneading part 32
May be fixed by an appropriate method such as screwing, bonding with an adhesive, or the like formed separately, but is preferably formed integrally from the viewpoint of strength and the like.

A hardening liquid supply means 4 according to the second invention is provided inside the piston 3. That is, a cylindrical space is formed in the axial direction so as to have a concentric circular cross section. In this space, a cylindrical portion 411 and a curing liquid extrusion hole 412 provided at one end thereof are provided. Is fitted. In addition, a hardening liquid extrusion sucker 42 is provided in the cylindrical portion 411 so as to be vertically movable. A hardening liquid sealing member 43 made of silicone rubber, butyl rubber, or the like is attached to an intermediate portion of the cylindrical portion 411 in the axial direction, and between the hardening liquid sealing member 43 and the end face of the hardening liquid extruding sucker 42. Is filled with the curing liquid 7.
Then, by pushing down the hardening liquid extrusion sucker 42, the hardening liquid sealing member 43 moves to the hardening liquid flow path 413 formed on the peripheral surface of the cylindrical portion 411, and the hardening liquid 7 is discharged into the hardening liquid extrusion hole. 412, the cylindrical base 11 and the kneading section 32
Is mixed with the calcium phosphate-based powder 8 contained in the space formed by Note that the curing liquid flow path 413 is
As shown in FIG. 3A, it can be formed as a large diameter portion having a larger diameter than the curing liquid sealing member 43, and has a constant diameter and is formed as a groove or the like formed on the peripheral surface of the cylindrical portion 411. You can also.

Further, the hardening liquid supply means 4 can be formed using a space 44 provided in the piston 3 as in the third invention. This is preferable because the kneading device can be made smaller and lighter, and can have a simple structure. The space 44 includes a cylindrical space 441 and a curing liquid extrusion port 442 provided at one end thereof.
And Inside the cylindrical space 441, a curing liquid extrusion sucker 42 is provided so as to be vertically movable. A hardening liquid sealing member 43 is attached to an intermediate portion of the cylindrical space 441 in the axial direction, and a hardening liquid sealing member 43 is provided between the hardening liquid extruding port 442 and the hardening liquid sealing member 43 on the peripheral surface of the cylindrical space 441. A liquid circulation part 443 is formed. This hardening liquid flowing section 443 is provided in FIG.
As shown in (2), it can be formed as a large diameter portion having a larger diameter than the curing liquid sealing member 43, and can be formed as a groove having a constant diameter and formed on the peripheral surface of the cylindrical space portion 441. .

The lid 5 may be any as long as it can prevent the kneaded material from leaking from the nozzle portion 12. The lid 5 has a bottomed cylindrical body fitted on the outer periphery of the nozzle portion, and a rod-shaped body inserted into the nozzle portion. And an integrally formed body which is formed integrally with the nozzle portion and which can be opened by being cut off. In this integrally formed body, the leakage of the contents is reliably prevented unless the kneading apparatus is broken off, and it is also possible to easily know from the appearance whether the kneading device has been used or not. Further, it may be shaped to be locked by a locking projection 121 for forming a luer lock provided on the outer peripheral surface of the nozzle portion 12. Further, by the locking projection 121, an injection needle and a catheter which can be used in a syringe or the like can be easily attached to and detached from the nozzle portion 12, and
Very useful in some clinical cases. In addition, this lid 5
It is more preferable that the central portion has a convex shape so that cement does not remain in the lid 5.

The stopper 6 is provided for the partition 2 in the cylinder 1.
Is a pin for fixing so as not to move except when required. By inserting this pin into a through hole provided on the side surface of the cylinder 1 and an insertion hole 21 provided on the side surface of the partition 2, the partition 2 is fixed at a predetermined position of the cylinder 1. Two to six stoppers 6 can be provided at substantially equal intervals over the entire circumference of the cylindrical base 11, and
Preferably, the number is four.

(2) Preparation of Calcium Phosphate-Based Cement by Kneading Apparatus Provided with Curing Liquid Supply Means Corresponding to the Third Invention First, in order to prevent contents from leaking from nozzle section 12 during kneading, The lid 5 was fitted and locked by the locking projection 121, and the opening of the nozzle 12 was closed. Thereafter, a predetermined amount of calcium phosphate mixed powder was put into the cylinder 1, the partitioning tool 2 was inserted into the cylinder 1, and fixed by the stopper 6. The shaft 31 of the piston 3 is screwed into the female thread of the partitioning tool 2 in advance.
The piston 3 is moved to a position where the kneading section 32 contacts the partitioning tool 2.
Is moved.

Next, a predetermined amount of pure water is poured as a hardening liquid into a cylindrical space 441 in which a disk-shaped hardening liquid sealing member 43 made of silicone rubber is mounted at an intermediate portion in the axial direction.
The hardening liquid extrusion sucker 42 was inserted from the opening end side to the vicinity of the position where the end face touches the hardening liquid. If a sealing material made of silicone rubber or the like is joined to the end surface of the curing liquid extrusion suction tip 42, the leakage of the curing liquid can be more reliably prevented, which is preferable. The kneading device in which the mixed powder and the curing liquid are sealed in this way is stored in a bag-like container made of a synthetic resin film or the like, if necessary, sterilized, and stored as it is until use. be able to. Since it can be stored in a sterilized state in advance, it can be used as a disposable device.

In use, the curing liquid extruder 42 was pressed down, the curing liquid sealing member 43 was pushed down to the curing liquid flowing section 443, and the curing liquid was discharged from the curing liquid extrusion port 442.
Thereafter, the kneading device was slightly rocked for about 10 to 15 seconds.
Next, an operation of rotating the handle portion 33 to move the kneading unit 32 to the nozzle unit 12 side and an operation of rotating the handle unit 33 in the opposite direction to move the kneading unit 32 to the partitioning tool 2 side are performed in 3 to 10 steps. This was repeated about once, and the mixed powder and the kneading liquid were kneaded. Since the kneading operation is performed in a closed kneading device, it is possible to prevent foreign matter and various bacteria from being mixed into the cement.

(3) Extrusion of the prepared cement The piston 3 was raised until the upper end surface of the kneading section 32 was in contact with the lower end surface of the partitioning tool 2, and then the stopper 6 was removed.
Next, the lid 5 was removed, and an injection needle or catheter optimal for the application site was attached to the nozzle unit 12, and the calcium phosphate cement was extruded and filled in the application site. The cement was quite viscous but could be easily and completely extruded.

(4) Evaluation of uniformity of kneaded material and JIS
Measurement of wet compressive strength by a method according to T6602 Evaluation of uniformity A red dye was blended into the curing liquid, and Examples 1 and 2 shown in Table 1 were used.
Was prepared as in (2) and extruded as in (3). When the appearance was visually observed, the cement of each of Examples 1 and 2 was sufficiently uniform, and a cement having excellent uniformity was obtained irrespective of the liquid-powder ratio and the viscosity difference due to the difference in this ratio. I understood.

Measurement of Wet Compressive Strength After the cement was filled in a mold having a depth of 11 mm and a diameter of 6 mm, it was cured at 37 ° C. and 100% relative humidity for 1 hour. Thereafter, the cured product was removed from the mold, and a simulated body fluid at 37 ° C (Na ⁺ ; 142.0 mM, K ⁺ ; 5.0 mM, C
a ²⁺ ; 2.5 mM, Mg ²⁺ ; 1.5 mM, HCO ₃ ⁻ ;
4.2 mM, Cl ⁻ ; 148.0 mM, HPO ₄ ²⁻ ;
0 mM, SO ₄ ²⁻ ; 0.5 mM, Tris buffer 33.3
(aqueous solution containing 6 mM in water and 36 mM in hydrochloric acid) for 24 hours. Next, the wet compressive strength was measured with a wet compressive strength tester (manufactured by Instron). still,
Using the mixed powder and the hardening liquid used in (2), the mixture was kneaded by a conventional method in a mortar to prepare the cements of Comparative Examples 1 and 2, and the wet compressive strength was measured in the same manner. Table 1 shows the results.

[0027]

[Table 1]

From the results shown in Table 1, it can be seen that the cement prepared by the kneading apparatus of the present invention can be easily kneaded by a conventional mortar using a mortar irrespective of the difference in viscosity due to the difference in the liquid powder ratio. It can be seen that a cured product having a wet compressive strength almost equivalent to that of Example 1 can be obtained.

It should be noted that the present invention is not limited to the above-described embodiment, but can be variously modified within the scope of the present invention depending on the purpose and application. For example, in the hardening liquid supply means 4, a bag-like container made of a resin film or the like filled with a required amount of the hardening liquid, or an ampoule or the like is filled in the cylindrical space 441.
The curing liquid can be supplied by pressing the bag-shaped container or the ampoule with the curing liquid extrusion sucker 42 immediately before kneading to break the bag or ampule. In this case, there is no need to mount the hardening liquid sealing member 43, and it is not necessary to form the hardening liquid flowing portion 443. Further, it is preferable that a metal net or the like is disposed at the hardening liquid extrusion port 442 to reliably prevent the broken bag-shaped container or the like from flowing out.

[0030]

According to the first to third aspects of the present invention, the calcium phosphate-based powder and the hardening solution can be stored in the same device, and can be stored as needed until use. Further, according to the third invention, the kneading device can be made smaller and lighter, and can have a simple structure.

Further, according to the fourth invention, the calcium phosphate cement can be easily and quickly prepared using the kneading apparatus of the first to third inventions, and the mixing, kneading and kneading of the hardening liquid with the powder can be performed. It is possible to continuously fill the application site with the object. For this reason, contamination of the kneaded material with foreign substances, various bacteria, and the like is sufficiently prevented.

[Brief description of the drawings]

FIG. 1 is a front view of a kneading device for a calcium phosphate cement.

FIG. 2 is a sectional view of a kneading device for a calcium phosphate cement.

FIG. 3A is a cross-sectional view illustrating an example of a curing liquid supply unit according to the second invention. (B) is sectional drawing which shows another example of the hardening liquid supply means corresponding to 3rd invention.

FIG. 4 is a cross-sectional view illustrating a state of a kneading device before a kneading operation.

FIG. 5 is a cross-sectional view illustrating a state where the kneaded material has been extruded.

[Explanation of symbols]

1; Cylinder, 11; Cylindrical base, 12; Nozzle, 12
1; locking projections; 2; partitioning tool; 21; insertion hole;
Grooves provided on the outer circumference, 23; Grooves provided on the inner circumference, 3;
Piston, 31; Shaft portion, 32; Kneading portion, 33; Handle portion, 34; Projection, 41; Cylindrical body, 411; Cylindrical portion, 412; Curing liquid extrusion hole, 413;
2: Curing liquid extruder, 43; Curing liquid sealing member, 44
1; Cylindrical space, 442; Curing liquid extrusion port, 443; Curing liquid circulation part, 5; Lid, 6; Stopper, 7; Curing liquid, 8; Calcium phosphate powder, 91 and 92;

 ──────────────────────────────────────────────────続 き Continuing on the front page (72) Inventor Takenori Sawamura 14-18, Takatsuji-cho, Mizuho-ku, Nagoya Japan Inside (72) Inventor Masaaki Hattori 14-18, Takatsuji-cho, Mizuho-ku, Nagoya (72) Inventor Masahiko Okuyama 14-18 Takatsuji-cho, Mizuho-ku, Nagoya Japan F-term (reference) 4C052 AA17 HH05 4C081 AB04 AB06 AC04 BA14 CD052 CE08 CE11 CF011 CF021 CF112 CF24 DA11 DC12 DC13 EA02 4C089 AA06 BA03 BA16 BE14 CA03 CA07

Claims (4)

[Claims] 1. A cylinder 1 having a cylindrical base 11 and a nozzle 12 provided at one end of the cylindrical base, a partition 2 slidably provided in the cylindrical base, and the partition inserted therethrough. A shaft portion 31 provided rotatably and vertically, a kneading portion 32 provided at one end of the shaft portion,
A piston 3 having a handle portion 33 provided at the other end of the shaft portion, a curing liquid supply means 4 provided in the piston, and a lid 5 provided at the tip of the nozzle portion
And a stopper 6 for fixing the partitioning tool to the other end of the cylindrical base. 2. The hardening liquid supply means has a cylindrical portion 411 and a hardening liquid extruding hole 412 provided at one end of the cylindrical portion, and has a cylindrical body fitted into a space provided in the piston. 41, a curing liquid extruder 42 provided vertically movably in the cylindrical portion, and a curing liquid sealing member 43 mounted at an axially intermediate portion of the cylindrical portion. The kneading device for calcium phosphate cement according to claim 1, wherein a hardening liquid flow path portion 413 is formed on a peripheral surface of the cylindrical portion between the hole and the hardening liquid sealing member. 3. A space 44 having a cylindrical space 441 provided in the piston and a hardening liquid extruding port 442 provided at one end of the cylindrical space.
A curing liquid extruder 42 provided vertically movably in the cylindrical space, and a curing liquid sealing member 43 mounted at an axially intermediate portion of the cylindrical space. 2. A curing liquid flow section 443 is formed between the extrusion port and the curing liquid sealing member on the peripheral surface of the cylindrical space.
The kneading device for a calcium phosphate-based cement according to the above. 4. A method for preparing calcium phosphate cement using the kneading device for calcium phosphate cement according to any one of claims 1 to 3, wherein the calcium phosphate cement is formed by the cylindrical base 11 and the partitioning tool 2. The calcium phosphate-based powder into the hardened liquid supply means 4
The hardening liquid is poured into the cylindrical portion 411 or the cylindrical space portion 441, and then the hardening liquid is supplied into the space. Then, the piston 3 is vertically moved and rotated in the cylinder 1. And kneading the calcium phosphate-based powder with the kneading liquid.