CN115216384A

CN115216384A - Disposable assembled active bone graft preparation device and preparation method

Info

Publication number: CN115216384A
Application number: CN202210836676.9A
Authority: CN
Inventors: 郭燕庆; 洪嫣霞
Original assignee: Individual
Current assignee: Individual
Priority date: 2022-07-15
Filing date: 2022-07-15
Publication date: 2022-10-21

Abstract

The invention provides a disposable assembled active bone graft preparation device and a preparation method thereof, wherein the preparation device comprises: a reaction chamber for storing PRP prepared by centrifuging bone graft material and blood, comprising: a main body part; a first port detachably connected to one end of the main body; and a second port detachably connected to the other end of the main body; a pressurizer, comprising: a sleeve detachably connected to the main body; one end of the push rod penetrates through the sleeve, is arranged in the sleeve and can move along the axial direction of the main body part; the pressurizing plate is connected to one end of the push rod arranged in the sleeve and used for pushing and pressurizing the inner cavity of the main body part; and the stopper is used for blocking the reaction bin. According to the technical scheme, the prepared PRP is distributed in the lacuna deeper than the bone graft material, the uniformity is better, the loose bone graft becomes more compact, the structure is simple, and the operability is high.

Description

Disposable assembled active bone graft preparation device and preparation method

Technical Field

Embodiments of the present invention relate generally to the field of medical devices, and more particularly, to a single-use assembled active bone graft maker and method of making.

Background

The bone graft is used for filling bone defects in various surgical operations of patients with bone defects, provides supporting force to a certain extent, promotes bone growth and repair, thereby promoting the recovery of the patients and relieving pains. In many cases, surgical procedures combine the use of bone grafts with any of a variety of tools, such as bone plates, screws, pedicle screws, rods, and the like, while implanting the bone graft for improved stability and orthopedic applications.

Bone graft repair materials include autologous bone, allogeneic bone and artificial bone.

Bone transplantation is widely applied to clinic, but most of the bone grafts are only provided with supporting capability but not provided with osteogenesis inducing activity no matter autologous bone, allogeneic bone or artificial bone, and the local fracture part has poor blood circulation, so that the fracture healing capability of the bone defect part is poor. Therefore, the development of an ideal active bone graft for promoting the healing of bone grafting with bone defect becomes an important subject in the fields of medicine and biological material science.

The bone graft material has the functions of loading cells and slowly releasing growth factors as a seed cell carrier, and most of the scaffold materials commonly used at present are solid materials, which have remarkable effects in the construction of tissue engineering bones. However, there are also some defects such as difficult shaping, complicated operation of loading growth factors and seed cells, low loading rate, easy loss of cells, and uneven distribution in the scaffold material.

The PRP contains a large amount of growth factors and fibrin for promoting osteogenesis, the bone graft contains a large amount of lacuna, the bone graft has good bearing and slow release capabilities, the PRP with the capability of promoting bone repair is loaded in the bone graft through a specific technology to prepare the active bone graft, the bone graft is induced and promoted while the supporting capability of the bone graft is kept, and the great clinical significance is achieved.

For the existing PRP centrifugation method, the existing centrifuge tube is of an integral structure, when the stratified blood is extracted after centrifugation, a platelet layer and a red blood cell layer are positioned in the same centrifuge tube, and red blood cells are mixed during platelet extraction, so that the purity of the extracted platelets is insufficient, the results of subsequent tests and detection are influenced, and the clinical curative effect is further influenced. Meanwhile, at present, a proper bone graft preparation device for preparing the load PRP is not available, the bone graft and the PRP are simply mixed, bioactive substances such as growth factors and the like contained in the PRP cannot be uniformly filled in a bone graft lacuna, the effect of enriching and slowly releasing the bioactive substances of the growth factors to promote bone repair cannot be achieved, and meanwhile, the possibility of infection caused by pollution increase due to multiple transfer is increased, and the clinical application and the effect of the active bone graft are seriously influenced.

Disclosure of Invention

According to the embodiment of the invention, the disposable assembled active bone graft preparation device and the preparation method are provided, so that PRP can enter into the lacunae deeper in the bone graft, the PRP is distributed more uniformly, and the loose bone graft becomes more compact.

In a first aspect of the invention, a single use assembled living bone graft maker is provided. The disposable assembled active bone graft maker comprises:

a reaction chamber for storing bone graft material and blood centrifuged PRP, comprising:

a main body portion; a first port detachably connected to one end of the main body; and a second port detachably connected to the other end of the main body;

a pressurizer, comprising:

a sleeve detachably connected to one end of the body part after the first port is separated from the body part; one end of the push rod penetrates through the sleeve, is arranged in the sleeve and can move along the axial direction of the main body part; the pressurizing plate is connected to one end of the push rod arranged in the sleeve and used for pushing and pressurizing the inner cavity of the main body part; and

a stopper for blocking the reaction chamber, wherein,

first, the first and second ports are mounted on the main body of the reaction chamber, and PRP is contained by separating blood using a centrifuge,

then the reaction cabin is blocked by the blocking device, the first port is removed from the main body part, the rotating and pushing pressurizer is replaced, and the PRP and the bone graft material in the reaction cabin are pressurized by the pressurizer.

In the above aspect and any one of the possible implementations, there is further provided an implementation in which an external thread is formed on an outer wall surface of the main body, an internal thread matching the main body is formed on an inner wall surface of the sleeve, and the sleeve and the main body are connected by a thread.

The above aspect and any possible implementation manner further provide an implementation manner, wherein a thread matched with the push rod is formed on an inner wall surface of the sleeve, and the push rod is screwed with the sleeve through the thread to screw and push the push rod.

The above aspect and any possible implementation further provide an implementation in which the pressure plate is matched with the inner cavity of the main body, and the pressure plate is in sealing abutment with the inner side wall of the main body when pushed into the inner cavity of the main body.

There is further provided in accordance with the above aspect and any one of the possible implementations an implementation in which the sleeve has a cylindrical portion connected at one end to the body portion, and

and a conical part formed at the other end of the cylindrical part, wherein the end of the conical part and the push rod are formed with mutually matched threads, and the push rod is rotated to move along the axial direction of the main body part.

In one embodiment, the wall surface of the main body is marked with graduation lines.

The above aspect and any possible implementation manner further provide an implementation manner, further comprising a red blood cell separation chamber and a platelet poor plasma separation chamber connected with the reaction chamber, wherein,

the red blood cell separation chamber is connected with the second port through a luer two-way joint with a valve and is used for storing a red blood cell layer after blood is centrifuged,

the red blood cell separation bin is provided with an injection hole assembly to form a channel communicated with the inner cavity of the red blood cell separation bin;

the platelet poor plasma separation chamber is connected with the first port through a luer two-way joint with a valve and is used for storing a platelet poor plasma layer obtained after blood centrifugation.

The above aspects and any possible implementations further provide an implementation that further comprises a pipetting needle, including a syringe and a needle, for withdrawing the PRP from the lower surface concentration portion of the reaction chamber.

The above aspects and any possible implementations further provide an implementation that further has a sterile protection compartment for being disposed outside the reaction compartment, the red blood cell separation compartment, and the platelet poor plasma separation compartment during centrifugation.

In a second aspect of the present invention, there is provided a method for preparing a living bone graft, based on the single-use assembled living bone graft preparation apparatus as described above, the method comprising:

placing the bone graft material in a reaction bin;

injecting blood into the red blood cell separation bin, the reaction bin and the platelet and plasma anemia separation bin, and performing centrifugal treatment;

after the first centrifugation is finished, a second port of the reaction bin is blocked by a stopper;

after the second centrifugation is finished, keeping the bone graft material and the PRP in the reaction bin;

the first port of the reaction bin is taken down, the pressurizer is connected with the reaction bin,

and (3) pressurizing the PRP and the bone graft material in the reaction cabin by using a pressurizer to obtain a compound of the bone graft material and the PRP.

The invention relates to a disposable assembled active bone graft preparation device and a preparation method thereof, which realize that PRP is distributed in deeper lacuna of a bone graft material by pressurizing PRP obtained by centrifuging the bone graft material and blood, the diffusion uniformity is better, the loose bone graft becomes more compact, and the more ideal PRP-loaded active bone graft is obtained, thereby more effectively achieving the effect of enriching and slowly releasing growth factor bioactive substances to induce and promote bone repair.

And, the preparation ware structure sets up simply, and medical personnel can conveniently carry out centrifugal treatment and directly carry out pressurization processing with PRP and the bone graft that deposit in the reaction storehouse that obtains through centrifugal treatment, and maneuverability is strong. The PRP and the bone graft material do not need to be taken out and transferred before pressurization, so that the pollution is prevented from being increased and further infection is avoided.

It should be understood that the statements herein reciting aspects are not intended to limit the critical or essential features of any embodiment of the invention, nor are they intended to limit the scope of the invention. Other features of the present invention will become apparent from the following description.

Drawings

The above and other features, advantages and aspects of various embodiments of the present invention will become more apparent by referring to the following detailed description when taken in conjunction with the accompanying drawings. In the drawings, like or similar reference characters designate like or similar elements, and wherein:

FIG. 1 shows a schematic view of a centrifuge tube of a preparation apparatus provided by an embodiment of the present invention;

FIG. 2 shows a schematic view of a reaction chamber of a preparation vessel provided by an embodiment of the present invention;

FIG. 3 illustrates an exploded view of a centrifuge tube of a preparation apparatus provided by an embodiment of the present invention;

FIG. 4 illustrates a schematic diagram of a centrifuge tube set for a first centrifugation of a preparation apparatus provided by an embodiment of the present invention;

FIG. 5 shows a schematic diagram of a second centrifuged tube assembly of a preparation apparatus provided by an embodiment of the present invention;

fig. 6 shows a schematic view of a spinning pressurizer provided by an embodiment of the invention;

FIG. 7 is a schematic diagram of the reaction chamber body, the rotary push pressurizer and the stopper assembly of the preparation device provided by one embodiment of the invention;

FIG. 8 is a schematic view of the reaction chamber body, the rotary pushing pressurizer and the bottom sealing assembly of the preparation apparatus provided by another embodiment of the invention;

wherein, the correspondence between the reference numbers and the component names in fig. 1 to 8 is:

10 an anemia platelet plasma separation bin, 11 sealing plugs and 12 ventilating plugs;

20 a reaction chamber, 21 a main body part, 22 a first port and 23 a second port;

30 red blood cell separation bins, 31 partition plates, 32 connecting rods, 33 adjusting caps, 34 injection hole assemblies and 341 injection hole assemblies;

40 sterile protection bin, 41 protection frame and 42 regulation cover;

50 rotary push pressurizers, 51 sleeves, 52 push rods, 53 pressurizing plates and 54 handles;

60 a plugging device;

a 70 luer two-way connector;

and (80) sealing the bottom.

Detailed Description

In order to make the objects, technical solutions and advantages of the embodiments of the present invention clearer, the technical solutions in the embodiments of the present invention will be clearly and completely described below with reference to the drawings in the embodiments of the present invention, and it is obvious that the described embodiments are some, but not all, embodiments of the present invention. All other embodiments, which can be obtained by a person skilled in the art without inventive efforts based on the embodiments of the present invention, shall fall within the scope of protection of the present invention.

In addition, the term "and/or" herein is only one kind of association relationship describing the association object, and means that there may be three kinds of relationships, for example, a and/or B, and may mean: a exists alone, A and B exist simultaneously, and B exists alone. In addition, the character "/" herein generally indicates that the former and latter related objects are in an "or" relationship.

The following describes a disposable assembled active bone graft maker and a method for making the same according to an embodiment of the present invention with reference to fig. 1 to 8.

Embodiment mode 1

As shown in fig. 1, a schematic view of a centrifuge tube of a preparation apparatus according to an embodiment of the present invention is provided; fig. 3 is an exploded view of a centrifuge tube of a preparation apparatus according to an embodiment of the present invention. The disposable assembled active bone graft preparation device of the embodiment of the invention comprises a centrifuge tube consisting of a platelet poor plasma separation chamber 10, a reaction chamber 20 and a red blood cell separation chamber 30 which are connected in sequence in a centrifugation stage, a sterile protection chamber 40 arranged outside the whole body of each chamber, and a rotary push pressurizer 50 and a plugging device 60 which are assembled with the reaction chamber 20 in an active bone graft pressurization stage.

The centrifuging tube includes anemia platelet plasma separation chamber 10, both ends open-ended reaction chamber 20, both ends open-ended red blood cell separation chamber 30 of both ends open-ended, and anemia platelet plasma separation chamber 10, reaction chamber 20 and red blood cell separation chamber 30 are through having the two-way joint 70 of luer of valve to connect detachably in proper order, and this valve can be opened or close.

As shown in fig. 2, which is a schematic view of a reaction chamber of a preparation apparatus according to an embodiment of the present invention, the reaction chamber 20 includes: a main body portion 21; a first port 22 detachably connected to one end of the main body 21; and a second port 23 detachably connected to the other end of the main body 21. The main body 21 is formed as a hollow cylinder with both ends open, and the first port 22 and the second port 23 are each formed as a cone with one end open and the other end open.

One end of the first port 22 extends towards one side of the main body part 21 along the axial direction to form a connecting part, the connecting part of the first port 22 and one end of the main body part 21 are provided with mutually matched threads, the outer wall surface of one end of the main body part 21 is provided with an external thread, the inner wall surface of the connecting part of the first port 22 is provided with an internal thread matched with the main body part 21, the first port 22 and the main body part 21 are connected through threads, and the other end of the first port 22 is connected with the platelet-poor plasma separation chamber 10.

One end of the second port 23 extends to one side of the main body 21 along the axial direction to form a connecting part, the connecting part of the second port 23 and the other end of the main body 21 are formed with mutually matched threads, the outer wall surface of the other end of the main body 21 is formed with an external thread, the inner wall surface of the connecting part of the second port 23 is formed with an internal thread matched with the main body 21, so that the second port 23 is connected with the main body 21 through the threads, and the other end of the second port 23 is connected with the red blood cell separation chamber 30.

Accordingly, the reaction chamber 20 is assembled by 3 detachable members, that is, the first port 22, the body 21, and the second port 23, in order to join the members in the blood centrifugation step, the red blood cell separation chamber 30 is detached and the second port 23 of the reaction chamber is sealed by the sealing device 80 in the second centrifugation step, and the first port 22 can be removed and replaced with the rotary push presser 50 in the subsequent pressurization step.

The first port 22 and the platelet poor plasma separation chamber 10, and the second port 23 and the erythrocyte separation chamber 30 are connected by luer two-way joints 70, that is, the two chamber bodies are connected by luer two-way joints 70, so that one of the chamber bodies can be detached without affecting the chamber bodies.

In one example, from top to bottom, a platelet poor plasma separation chamber 10, a reaction chamber 20 and a red blood cell separation chamber 30 are coaxially arranged, the platelet poor plasma separation chamber 10 is used for storing a platelet poor plasma layer of blood after centrifugation, the reaction chamber 20 is used for storing PRP of blood after centrifugation, and the red blood cell separation chamber 30 is used for storing a red blood cell layer of blood after centrifugation.

In order to facilitate the connection between the luer two-way joint 70 and the three cabin bodies, the platelet plasma separating cabin 10 and the erythrocyte separating cabin 30 are composed of a cylindrical part and a closing structure in the shape of a cone, wherein the end of the platelet plasma separating cabin 10 connected with the reaction cabin 20 is the closing structure, the end of the erythrocyte separating cabin 30 connected with the reaction cabin 20 is the closing structure, and the size of the opening at the tail end of the closing structure can be determined according to the size of the opening at the end part of the luer two-way joint 70, so long as the platelet plasma separating cabin 10, the reaction cabin 20 and the erythrocyte separating cabin 30 are respectively in sealed connection with the luer two-way joint 70.

Optionally, the closing-up structure is an inclined structure, that is, the closing-up structure is a side wall surface of the platelet poor plasma separation chamber 10, the reaction chamber 20 or the red blood cell separation chamber 30, which is inclined at an angle of 45-60 ° towards its axial direction at its end.

In this embodiment, the closing-in structure is provided, which is more favorable for connection with the luer bi-pass joint 70, and at the same time, makes the blood in the centrifuge tube flow into the next chamber more easily.

An injection hole assembly 34 is arranged at the closing structure of the red blood cell separation chamber 30, optionally, the injection hole assembly 34 is a cylinder connected with the outer surface of the red blood cell separation chamber 30 and parallel to the bottom wall of the red blood cell separation chamber 30, the cylinder is hollow, a channel communicated with the inner cavity of the red blood cell separation chamber 30 is formed, and blood is injected into the red blood cell separation chamber 30 from the channel. Further, one end of the injection hole assembly 34 far away from the outer surface of the red blood cell separation chamber 30 does not exceed the plane where the side wall of the cylindrical part of the red blood cell separation chamber 30 is located, so that the fracture of the injection hole assembly 34 caused by collision is avoided. In this embodiment, blood may be injected into the red blood cell separation chamber 30 through the injection hole assembly 34.

Optionally, as shown in fig. 3, the centrifuge tube further comprises an injection hole assembly block cap 341, and the injection hole assembly 34 is sealed with the injection hole assembly block cap 341 when the injection hole assembly 34 is not in use.

Be provided with division plate 31 in red blood cell separation chamber 30, be provided with first cavity and the second cavity by division plate 31 partition in red blood cell separation chamber 30, first cavity is located division plate 31 and is close to one side of reaction chamber 20, and can communicate with reaction chamber 20, the second cavity is located division plate 31 and keeps away from one side of reaction chamber 20, and division plate 31 can slide along the direction of height of red blood cell separation chamber 30, with the volume size of adjusting first cavity and second cavity, the one end that red blood cell separation chamber 30 kept away from reaction chamber 20 is provided with the adjusting device who is connected with division plate 31, can drive division plate 31 through adjusting device and slide along the direction of height of red blood cell separation chamber 30, with the high position of regulation division plate 31 in red blood cell separation chamber 30.

The partition plate 31 is hermetically connected with the inner side wall of the red blood cell separation chamber 30, and optionally, the partition plate 31 is made of a rubber material and is connected with the inner side wall of the red blood cell separation chamber 30 in an interference fit manner.

The adjusting device comprises a connecting rod 32 and an adjusting cap 33, the adjusting cap 33 is sleeved on the outer side wall of the bottom end of the erythrocyte separating bin 30 and can move along the height direction of the erythrocyte separating bin 30, the connecting rod 32 is respectively connected with the partition plate 31 and the adjusting cap 33, and the partition plate 31 can be driven to slide along the height direction of the erythrocyte separating bin 30 under the action of the adjusting cap 33. Further, the outer side wall of the red blood cell separation chamber 30 is provided with an external thread, the adjusting cap 33 is provided with an internal thread matched with the external thread, and the adjusting cap 33 is in threaded connection with the red blood cell separation chamber 30. When the position of the partition plate 31 in the red blood cell separation chamber 30 needs to be adjusted, the adjusting cap 33 can be screwed, so that the depth of the connecting rod 32 extending into the red blood cell separation chamber 30 is changed, and the position of the partition plate 31 in the red blood cell separation chamber 30 is changed to change the volume of the red blood cell separation chamber 30.

In this embodiment, the adjusting cap 33 is connected with the red blood cell separation chamber 30 by a screw thread, so that the accuracy of adjusting the volume of the red blood cell separation chamber 30 is higher.

The end face of one end of the platelet poor plasma separation chamber 10 far away from the reaction chamber 20 is provided with an opening in the middle. Optionally, as shown in fig. 3, the centrifuge tube further includes a sealing plug 11 and a ventilation plug 12 that are matched with the opening, the sealing plug 11 is used after blood is injected into the centrifuge tube during centrifugation, the opening can be sealed, the ventilation plug 12 is used when blood is injected into the centrifuge tube, and a bacteria-proof and dust-proof filter membrane is arranged in the ventilation plug 12, so that it is possible to prevent bacteria in the air from entering the centrifuge tube while ensuring that the air pressure in the centrifuge tube is the same as the external air pressure.

A sterile protection bin 40 is also arranged outside the centrifuge tube formed by assembling the platelet poor plasma separation bin 10, the reaction bin 20 and the erythrocyte separation bin 30, and is used for keeping the centrifuge tube in a sterile environment during centrifugation. Aseptic protection storehouse 40 includes fender bracket 41 and regulation lid 42, and wherein, the one end of fender bracket 41 is sealed the one end opening, and the centrifuging tube is placed in fender bracket 41, and regulation lid 42 lid dress is at the opening part of fender bracket 41, and through threaded connection between the fender bracket 41 to through the position of adjustment regulation lid 42, make the bottom of fender bracket 41 and regulation lid 42 press from both sides tight fixed centrifuging tube jointly, further strengthened the rigidity of centrifuging tube, make the centrifuging tube not fragile when the centrifugation.

In specific use, as shown in fig. 4, a schematic view of a centrifuge tube assembly for the first centrifugation of the preparation apparatus according to the embodiment of the present invention is shown, the centrifuge tube is placed in the sterile protection bin 40, a valve of the luer two-way joint 70 is opened, blood is injected into the red blood cell separation bin 30, and the blood in the centrifuge tube is centrifuged, and the processed blood is divided into a platelet poor plasma layer, a PRP (platelet rich plasma) layer and a red blood cell layer from top to bottom. When the red blood cells need to be extracted, the height of the partition plate 31 in the red blood cell separation bin 30 can be adjusted through the adjusting device, so that the volume of the first cavity is adjusted, after the height of the red blood cells reaches a proper position, the valve of the luer double-way joint 70 between the red blood cell separation bin 30 and the reaction bin 20 is closed, all or most of the red blood cells positioned at the lowermost layer are positioned in the first cavity according to actual needs, the red blood cell separation bin 30 is disassembled and discarded, the platelet poor plasma separation bin 10 and the reaction bin 20 are left, the luer double-way joint 70 between the red blood cell separation bin 30 and the reaction bin 20 is sealed by the plugging device 60, and then the centrifugal device is placed in a new sterile protection bin 40 to perform secondary centrifugal treatment. Fig. 5 is a schematic diagram of a second centrifuged tube assembly of a preparation apparatus according to an embodiment of the present invention.

It should be noted that the bottom area of the stopper 60 is large, so that it is possible to prevent the parts from being damaged due to excessive stress concentration caused by excessive pressure at the lower part of the luer double-way joint 70 during centrifugal movement.

When the platelet plasma PRP is required to be extracted after the second centrifugal treatment, the valve of the luer two-way joint 70 between the platelet plasma separating compartment 10 and the reaction compartment 20 is closed, the platelet plasma separating compartment 10 is discarded, and the reaction compartment 20 is reserved, wherein the required PRP is the PRP.

In this embodiment, the platelet poor plasma separation chamber 10, the reaction chamber 20, and the erythrocyte separation chamber 30, which are detachably connected by the luer two-way joint 70, together constitute a centrifugal tube, the erythrocyte separation chamber 30 is provided with a partition plate 31 and an adjusting device, and the position of the partition plate 31 in the erythrocyte separation chamber 30 is adjusted by the adjusting device to position PRP in the reaction chamber 20, thereby ensuring high purity of platelets and no contamination of erythrocytes when PRP is extracted.

In the present embodiment, the total volume of the bone tissue centrifuge tube is 150 or 300ml, corresponding to 100 or 250ml of blood, the volume of the platelet poor plasma separation chamber 10 may be 60 or 120ml, the volume of the reaction chamber 20 may be 20 or 40ml, and the maximum volume of the erythrocyte separation chamber 30 may be 60 or 120ml. It should be noted that the red blood cell separation chamber 30 can be changed in capacity by adjusting the position of the partition plate 31 therein. The total capacity of the centrifuge tube, the blood sampling amount and the capacity of each bin body can be adjusted according to actual requirements.

In the present embodiment, in order to enhance the uniformity of the bone graft PRP in the bone graft material cavity and to make the active bone graft more compact, a pressurizer is further provided, which in the present embodiment is provided as a rotary pushing pressurizer 50. Fig. 6 is a schematic view of a rotary-push pressurizer according to an embodiment of the present invention; fig. 7 is a schematic view showing the assembly of the main body 21, the rotary pushing presser 50, and the stopper 60 of the reaction chamber 20 of the preparation apparatus according to the embodiment of the present invention. The two ends of the reaction chamber 20 are respectively assembled with a rotary push pressurizer 50 and an occluder 60, and the PRP and the bone graft material in the reaction chamber 20 are pressurized by the rotary push pressurizer 50.

After the first centrifugation, the stopper 60 is plugged outside the luer double-way connector 70 at the second port 23 of the reaction chamber 20.

After the second centrifugation, the rotary-push presser 50 is attached to one end of the body 21 by removing the first port 22. The rotary push presser 50 includes: a sleeve 51 detachably connected to one end of the body 21 after the first port 22 is separated from the body 21; a push rod 52 having one end passing through the sleeve 51, disposed in the sleeve 51, and movable in the axial direction of the body portion 21; a pressurizing plate 53 connected to one end of the push rod 52 provided in the sleeve 51 and pushing the pressurizing plate to the inner cavity of the main body; and a handle 54 provided at the other end of the push rod 52.

In the present embodiment, the rotary-push presser 50 is provided at one end of the main body 21, instead of the first port 22; the stopper 60 is provided at the other end of the body 21 outside the second port 23 to block the reaction chamber 20 on the side opposite to the rotary-push presser 50. And the relative position of the rotary-push presser 50 and the main body 21 can be adjusted.

The sleeve 51 of the rotary-push pressurizer 50 has a cylindrical portion having one end connected to the body portion 21 and a conical portion formed at the other end of the cylindrical portion and coaxially provided, and an internal thread matching the body portion 21 is formed on the inner wall surface of the cylindrical portion of the sleeve, and the sleeve 51 and the body portion 21 are connected by a screw. The inner wall of the end of the conical portion and the push rod 52 are formed with threads that are engaged with each other, and the push rod and the sleeve are screwed together by the threads, and the push rod 52 is rotated to move in the axial direction of the body portion 21.

In the present embodiment, the push rod 52 is provided to fit the sleeve 51 having an internal thread, and the push rod 52 is moved in the axial direction by screwing and pushing, and the pressurizing plate 53 is moved in the axial direction. It is easier to control the pressure accurately.

In other embodiments, the sleeve 51 may not be provided with threads, and the push rod 52 and the sleeve 51 are provided with corresponding sliding grooves, so that the push rod 52 can be moved in the axial direction by pressing the push rod 52, and the pressurizing plate 53 can be moved in the axial direction.

The pressurizing plate 53 is matched with the inner cavity of the main body 21, and the pressurizing plate 53 is in sealing contact with the inner side wall of the main body 21 when pushed to the inner cavity of the main body 21. In other embodiments, the pressing plate 53 may be formed with an aperture for adjusting the pressure on both sides of the pressing plate 53.

A handle 54 is also provided at the other end of the push rod 52 to facilitate rotation of the push rod 52.

When in use, the reaction chamber 20 is firstly provided with the first and

second ports

22 and 23, and is connected with the erythrocyte separation chamber 30 and the platelet plasma separation chamber 10, PRP is separated and contained by a centrifugal machine, then the erythrocyte separation chamber 30 is separated after the first centrifugation, the luer double-way joint 70 between the erythrocyte separation chamber 30 and the reaction chamber 20 is sealed by the sealing device 60, the platelet plasma separation chamber 10 is separated after the second centrifugation, the first port 22 is removed, the rotary push pressurizer 50 is replaced, the push rod 52 is rotated by the rotary push pressurizer 50 to push the pressure plate 53 to the inside of the main body part 21, and the PRP and the bone graft in the reaction chamber are pressurized.

And a pipetting needle for withdrawing PRP of a lower surface concentration portion in the reaction chamber 20 before replacing the rotary pushing pressurizer 50, comprising a syringe and a needle connected to the syringe. When the device is used, the luer two-way connector 70 arranged on the first port 22 is opened, the needle head extends into the reaction chamber, the PRP is extracted to approximately the interface between the main body part 21 and the first port 22, more precisely, the wall surface of the main body part 21 is marked with scale marks, and the PRP is extracted to the specified scale marks.

Based on the above preparation device, the embodiment of the invention also provides a preparation method of the active bone graft, which is characterized in that the active bone graft composition is formed by diffusing and infiltrating the platelet rich plasma PRP prepared by blood in the bone graft material, wherein the bone graft material can be autologous bone, allogeneic bone or artificial bone.

Specifically, the preparation method of the active bone graft provided by the embodiment of the invention comprises the following steps:

step S1, placing the bone graft material into a reaction bin 20, and assembling an erythrocyte separation bin 30, the reaction bin 20 and an anemia platelet and plasma separation bin 10.

And S2, injecting blood into a centrifugal tube consisting of the red blood cell separation bin 30, the reaction bin 20 and the platelet and plasma anemia separation bin 10 from the injection hole assembly 34 of the red blood cell separation bin 30, placing the centrifugal tube into a sterile protection bin 40, and performing centrifugal treatment.

In this embodiment, when blood is injected into the red blood cell separation chamber 30, the valve of the luer two-way joint 70 between the platelet-poor plasma separation chamber 10 and the reaction chamber 20 is in an open state, the valve of the luer two-way joint 70 between the reaction chamber 20 and the red blood cell separation chamber 30 is also in an open state, a gas-permeable plug 12 is used at the opening of the platelet-poor plasma separation chamber 10, the blood is injected through the injection hole assembly 34 on the red blood cell separation chamber 30, after the blood is injected, the injection hole assembly 34 is sealed by the injection hole assembly plug cap 341, and the gas-permeable plug 12 is replaced by the sealing plug 11.

Step S3, adjusting the height of the partition plate 31 in the red blood cell separation chamber 30, so that all or most of the red blood cells in the lowest layer are in the red blood cell separation chamber 30.

It should be noted that, in the blood after the centrifugal treatment, the red blood cells are located in the lowest layer, and the height of the partition plate 31 in the red blood cell separation chamber 30 can be adjusted so that all or most of the red blood cells located in the lowest layer are located in the red blood cell separation chamber 30. So that the most part of the red blood cells in the lowest layer are in the red blood cell separation chamber 30.

And S4, closing a valve of the luer two-way joint 70 between the reaction bin 20 and the red blood cell separation bin 30, and detaching the red blood cell separation bin 30.

And S5, placing the platelet-poor plasma separation chamber 10 and the reaction chamber 20 into a new sterile protection chamber 40, and centrifuging the blood in the platelet-poor plasma separation chamber 10 and the reaction chamber 20 again.

In this embodiment, when the re-centrifugation treatment is performed, the stopper 60 may be used to block the luer double-way connection 70 between the reaction chamber 20 and the erythrocyte separation chamber 30.

And S6, closing a valve of a luer two-way joint 70 between the anemia platelet plasma separation chamber 10 and the reaction chamber 20, disassembling the anemia platelet plasma separation chamber 10, and keeping the bone graft material and the PRP in the reaction chamber.

Step S7, the luer double-way connector 70 provided at the first port 22 is opened, the reaction chamber 20 is inserted with a pipette needle, and the PRP having a low surface concentration is extracted to the scale line defined in the main body 21.

In step S8, the first port 22 of the reaction chamber 20 is removed, and the rotary push presser 50 is connected to one end of the main body 21 of the reaction chamber 20.

Step S9, rotating the handle 54 of the rotary-push presser 50 to push the push rod 52 to push the pressure plate 53 to move toward the inner side of the main body 21 of the reaction chamber 20, and pressing the PRP and the bone graft material in the reaction chamber to obtain a composition of the bone graft material and the PRP.

Embodiment mode 2

Embodiment 2 provides a preparation apparatus substantially the same as embodiment 1 except that the second port 23 is replaced with a back cover 80 before applying pressure to the reaction chamber 20, opposite to the rotary push pressurizer 50. Fig. 8 is a schematic view of the assembly of the reaction chamber body, the rotary pushing presser and the bottom cover of the preparation apparatus according to another embodiment of the present invention.

The back cover 80 is detachably connected to the other end of the main body 21 after the second port 23 is separated from the main body 21 on the side opposite to the rotary pushing presser 50.

The bottom surface of the back cover 80 is flat, a side surface connected with the main body portion 21 extends from the bottom surface to the axial direction of the back cover, an internal thread matched with the external thread of the main body portion 21 is formed inside the side surface of the back cover 80, the back cover 80 is connected to the other end of the main body portion 21 through the thread, and the relative position of the back cover 80 and the main body portion 21 can be adjusted.

In use, after two times of centrifugation, the second port 23 of the reaction chamber 20 can be removed and replaced with the back cover 80.

An embodiment of the present invention also provides a method for preparing a living bone graft, which is the same as embodiment 1 except that step S8 of embodiment 1 is followed by the steps of:

after the rotary push presser 50 is disposed at one end of the main body 21 of the reaction chamber 20, the reaction chamber 20 is turned upside down, the second port 23 of the reaction chamber 20 is removed, and the back cover 80 is connected to the other end of the main body 21 of the reaction chamber 20 to be used in cooperation with the rotary push presser 50 for pressing.

In addition, in some embodiments, the bone graft material may be introduced into the PRP of the reaction chamber 20 after centrifugation to obtain the PRP.

According to the disposable assembled active bone graft preparation device, PRP obtained by centrifuging the bone graft material and blood is pressurized, so that the PRP is distributed into a cavity deeper than the bone graft material, the diffusion uniformity is better, the loose bone graft becomes more compact, and the more ideal PRP-loaded active bone graft is obtained, thereby more effectively achieving the effect of enriching and slowly releasing growth factor bioactive substances to induce and promote bone repair.

And, the preparation ware structure sets up simply, and medical personnel can carry out centrifugal treatment and directly carry out pressurization treatment with PRP and the bone graft that deposit in the reaction bin that obtains through centrifugal treatment to blood conveniently, and maneuverability is strong. The PRP and the bone graft material do not need to be taken out and transferred before pressurization, so that the pollution is prevented from being increased and further infection is avoided.

In the description of the present specification, the terms "connect", "mount", "fix", and the like are to be understood broadly, for example, "connect" may be a fixed connection, a detachable connection, or an integral connection; may be directly connected or indirectly connected through an intermediate. The specific meaning of the above terms in the present application can be understood by those of ordinary skill in the art as the case may be.

It is noted that while for simplicity of explanation, the foregoing method embodiments have been described as a series of acts or combination of acts, it will be appreciated by those skilled in the art that the present disclosure is not limited by the order of acts, as some steps may, in accordance with the present disclosure, occur in other orders and concurrently. Further, those skilled in the art will appreciate that the embodiments described in the specification are exemplary embodiments and that acts and modules are not necessarily required for the disclosure.

It should be understood that various forms of the flows shown above may be used, with steps reordered, added, or deleted. For example, the steps described in the present disclosure may be executed in parallel or sequentially or in different orders, and are not limited herein as long as the desired results of the technical solutions disclosed in the present disclosure can be achieved.

The above detailed description should not be construed as limiting the scope of the disclosure. It should be understood by those skilled in the art that various modifications, combinations, sub-combinations and substitutions may be made, depending on design requirements and other factors. Any modification, equivalent replacement, and improvement made within the spirit and principle of the present disclosure should be included in the scope of protection of the present disclosure.

Claims

1. A single-use assembled living bone graft maker, comprising:

a reaction chamber for storing PRP prepared by centrifuging bone graft material and blood, comprising: a main body part; a first port detachably connected to one end of the main body; and a second port detachably connected to the other end of the main body;

a pressurizer, comprising: a sleeve detachably connected to one end of the body part after the first port is separated from the body part; one end of the push rod penetrates through the sleeve, is arranged in the sleeve and can move along the axial direction of the main body part; the pressurizing plate is connected to one end of the push rod arranged in the sleeve and used for pushing and pressurizing the inner cavity of the main body part; and

a stopper for blocking the reaction chamber, wherein,

then the reaction cabin is blocked by the blocking device, the first port is removed from the main body part and replaced by the pressurizer, and the PRP and the bone graft material in the reaction cabin are pressurized by the pressurizer.

2. The single-use assembled living bone graft maker of claim 1,

and the outer wall surface of the main body part is provided with an external thread, the inner wall surface of the sleeve is provided with an internal thread matched with the main body part, and the sleeve and the main body part are connected through threads.

3. The single-use assembled active bone graft maker of claim 1,

the inner wall surface of the sleeve is provided with threads matched with the push rod, the push rod is screwed with the sleeve through the threads, and the push rod is pushed in a screwing mode.

4. The single-use assembled living bone graft maker of claim 1,

the pressure plate is matched with the inner cavity of the main body part, and the pressure plate is pushed to the inner cavity of the main body part and is in sealing butt joint with the inner side wall of the main body part.

5. The single-use assembled active bone graft maker of claim 4,

the sleeve has a cylindrical portion connected at one end to the main body portion, an

And a conical part formed at the other end of the cylindrical part, wherein threads matched with each other are formed at the end part of the conical part and the push rod, and the push rod is rotated to move along the axial direction of the main body part.

6. The single-use assembled active bone graft maker of claim 1,

the wall surface of the main body part is marked with scale marks.

7. The single-use assembled active bone graft maker of claim 1,

also comprises an erythrocyte separating bin and a platelet and plasma separating bin which are connected with the reaction bin, wherein,

the red blood cell separation bin is connected with the second port through a luer two-way joint with a valve and is used for storing a red blood cell layer after blood is centrifuged,

the platelet poor plasma separation chamber is connected with the first port through a luer bi-pass joint with a valve and is used for storing a platelet poor plasma layer formed by centrifuging blood.

8. The single-use assembled living bone graft maker of claim 1,

and the liquid transferring needle comprises a syringe and a needle head and can be used for extracting PRP of the lower-concentration part of the surface layer in the reaction chamber.

9. The single-use assembled living bone graft maker of claim 7,

and the sterile protection cabin is used for being arranged outside the reaction cabin, the red blood cell separation cabin and the platelet poor plasma separation cabin during centrifugation.

10. A method for preparing a living bone graft, based on a single-use assembled living bone graft preparation device according to any one of claims 1 to 9, comprising:

placing the bone graft material in a reaction bin;

the first port of the reaction bin is taken down, the pressurizer is connected with the main body part of the reaction bin,

and (3) pressurizing the PRP and the bone graft material in the reaction cabin by using a pressurizer to obtain the composition of the active bone graft material and the PRP.