DE202015101413U1 - Blood separation device - Google Patents

Abstract

A blood separation device for separating platelet rich plasma, comprising: a sleeve having a first end and a second end along an axial direction, a first opening being formed at the first end, a second opening being formed at the second end Inner rod assembly coaxially encircled by the sleeve, whereby the inner rod assembly is reciprocally movable within the sleeve along the axial direction, the inner rod assembly further including a rod body and a barrel body, the rod body and the barrel body being threadedly connected to each other, so that the bar body can be optionally removed from the tub body after connection to the tub body, a front cover coaxially disposed with the sleeve at the first end and engaged with the first opening to close the first opening, and a front cover rear cover, the is disposed coaxially with the sleeve at the second end and is engaged with the second opening to close the second opening, wherein the rear cover is further provided with a central through hole, so that the rod body along the axial direction through the central through hole and is penetrated through the second opening and connected to the tub body.

Description

Technical area

 The present invention relates to a blood separation device and, more particularly, to a device based on centrifugation which causes phase separation in the blood to separate and collect a particular plasma layer.

State of the art

Blood is rich in a variety of components, with different components having different functions. In the conventional methods, the peripheral blood directly obtained by blood collection is called "whole blood", and it contains blood cells, serum, plasma and several biochemical molecules, the different components serving various medical purposes. The separation of whole blood is nowadays widespread in the medical practice, in which respect very often a centrifugation is carried out. To obtain the desired blood component, the blood components are separated by centrifugation due to the differences in the proportions in different phases.

 In general, the blood taken from the patient may be separated into different phases by centrifugation following treatment with an anticoagulant in accordance with the proportions. The plasma in the upper layer and the sedimentation of the erythrocytes in the lower layer can be clearly observed. The plasma in the upper layer can usually be further divided into a smaller proportion of the platelet-poor plasma (abbreviated "PPP") and a larger proportion of the platelet-rich plasma ("platelet-rich plasma", abbreviated "PRP"). be separated. As it is further separated, a plasma layer of special components forms between the plasma in the upper layer and the sedimentation of the erythrocytes, which is called a buffy coat, which is basically still a part of the platelet-rich plasma. However, the volume of the buffy coat is rather small compared to the volume of the above-mentioned plasma in the upper layer or the volume of sedimentation of the erythrocytes in the lower layer and accounts for only about 1% of the total volume of the blood. For this reason, it appears in the stratified blood as a thin layer.

 Within the above-mentioned blood components, the medical value of plasma has been increasingly recognized in recent years and has since become very important. In particular, the medical applications of autologous platelet-rich plasma (to shorten the description, this is referred to below by its abbreviation "PRP") and the autologous buffy coat have a wide range of uses, and the medicinal effects are satisfactory and very satisfactory for sure. In particular, the buffy coat contains a high concentration of platelets, lymphocytes and growth factors, which also contains a small amount of stem cells and is therefore particularly valuable.

 It is known that platelets in PRP after appropriate stimulation secrete a variety of growth factors and can set biochemical mechanisms in motion, thereby causing a variety of physiological repair mechanisms of the cells, such. Proliferation, movement, differentiation and collagen synthesis. In addition, the buffy coat contains a small amount of valuable adult stem cells, hematopoietic stem cells and mesenchymal stem cells. Within the aforementioned platelet and growth factor environment, post-activation stem cells may also participate in tissue repair, which has contributed to making PRP research and application more and more one of the most important areas of regenerative medicine. PRP can promote tissue repair and has been extensively studied and put to practical use in clinical medicine. The main purpose is to promote wound healing and tissue repair, e.g. For example, in dental treatments, in orthopedic treatments, in eye treatments, in the treatment of arthritis, in plastic surgery, in beauty medicine, which is why PRP has a high application value.

The currently most popular method of PRP recovery relies on centrifugation using centrifuge tubes. However, after phase separation and centrifugation of the blood, the volume of PRP is relatively small compared to the total blood volume. In particular, from a common volume of blood collection (10 to 20 ml of whole blood), only a thin layer of buffy coat can be obtained after centrifugation, making it difficult for the operator to locate the buffy coat between the plasma layer and the erythrocyte layer make and disconnect. In addition, a deep ingesting tool must be used during the procedure because, as previously stated, the thin layer of buffy coat is between the plasma layer and the erythrocyte layer, severely affecting the effect of phase separation of the blood and consequently results in poor operating efficiency. All this leads to the fact that for the user the removal is associated with great difficulties. In addition to the adverse operation, safety concerns related to environmental pollution and risk of infection are added, as the PRP or buffy coat obtained by centrifugation relies on a number of complex separation procedures requiring multiple pipetting operations, especially for stratified blood separation, resulting in safety issues can lead.

Therefore, some manufacturers have produced possible improvement methods for the problems mentioned. For example, Chinese patents no. CN202478263U and no. CN201469752U revealed very similar improvement methods. The two methods use a conventional blood collection syringe. After removal of the blood, the injection needle is removed and thereafter the syringe opening (ie, the original junction of the needle) is covered by a container with a plunger, then the syringe already assembled and the container comprising it are centrifuged together. During centrifugation, the syringe is at an upper position and the container is at a lower position. The recovery of the plasma after centrifugation is accomplished by draining the blood downwardly from the syringe and further injecting it into the container, causing the PRP to descend down to the syringe opening, then inserting the needle and the PRP becomes directly injected back into the body of the patient from whom the blood was taken.

 However, the devices of the above two patents still have some disadvantages to be improved in operation. More specifically, while the existing syringes can be used as a blood collection and injection device in the designs disclosed in the two patents, the syringe and container engage each other, both having an elongated tubular shape, so that the entire device retracts In particular, when the joint is in a very unstable state, it is very likely that the joint will loosen. In addition, the device is so limited because of its own shape and centrifugation principle for separating the blood that a syringe and a container must be inserted into the device during centrifugation, whereby the two components must be centrifuged together. As mentioned above, although the construction of this device is already instable, it is forced to take a strong force during centrifugation, so that the problem of detachment is likely to occur. In case of a relaxation of the construction of this device, serious safety problems such as blood leakage and contamination are very likely to be caused. Moreover, in order not to impair the effect of centrifuging the blood, in the application of the above apparatus, the blood cell layer, the proportion of which is larger than that of the PRP, must be pushed out at the time of PRP recovery, then the PRP is controlled by manual control held close to the exit of the syringe. However, the outflow of liquid due to gravity is prone to failure and difficult to operate. It is also possible that PRP may be accidentally released, thereby affecting the effect of removal. If you want to separate and remove the thin layered buffy coat, the above problem is even more pronounced.

 Furthermore, US Patent Application No. 20100025342A1 discloses a blood separation device whose arrangement is also based on the principle of the conventional syringe, which comprises two syringes. The first syringe is used to insert the needle to remove whole blood. After removal of the whole blood, the needle is replaced with a cap to seal the opening. Subsequently, the syringe opening is placed facing down and carried out on this a weak centrifugation method to separate the blood in a first stage. Thereafter, the second syringe is inserted with a needle into the dedicated tubing of the push handle of the first syringe to aspirate the plasma, mostly separated in the first stage (i.e., the liquid in the upper layer obtained by initial centrifugation). Then the needle is replaced with another cap and the opening of the second syringe is sealed. Subsequently, a strong centrifugation procedure is performed to more accurately separate the plasma. Finally, certain phases of the blood are vented down (i.e., in the direction of gravity) to obtain the PRP or buffy coat.

However, conventional syringes are also used in the blood separation device of the above U.S. patent application, and at least two syringes must be used to achieve the goal. In practice, in order to insert the second syringe exactly into the first syringe and thus stably aspirate the stratified blood, the sizes, specifications and configurations of the two syringes must be specifically designed to stably join the two syringes together. Therefore, the syringes certainly can not be used directly based on the specifications for the two syringes. However, in a single blood separation two syringes are already consumed, resulting in high Production costs result. Further, this device may potentially improve the functionality of the blood separation, but the operation relies on two-stage centrifugation and pipetting. The problem of complicated work steps is not solved yet. Furthermore, contamination may occur during operation due to insertion of the syringes in the separation process. In addition, this device is limited to the shape in which a wing is located at the end of the sleeve of the conventional syringe so that its direction of insertion is limited during centrifugation (because of the wing, the conventional syringe can not be inserted into the commonly used tube base), so that in order to obtain PRP, it is necessary to use a method of ejecting it downward, so that at the end of the force direction centrifugation, a cap must be placed to seal the opening, the cap, when opening the syringe should properly close under the strong centrifugal force, but must have a custom-fit form, which has the disadvantage of high production costs. Furthermore, in order not to impair the result of the centrifuged blood after the phase separation, this device still relies on the previously described influence of gravity, so that the following problems may occur: the stratified blood is susceptible to interference during operation; the PRP is accidentally left out; the effect of extraction is impaired; the recovery of the Buffy Coats is ineffective.

 In summary, there are still some problems with the current technical separation of PRP processes. Incorrect operation can cause a serious problem of sample contamination. Due to the above disadvantages, an overriding goal for those skilled in the art is to provide a device with which PRP can be effectively obtained by simple operation with simplified steps.

Object of the invention

In order to overcome the above-mentioned drawbacks, the present invention provides a blood separation device of simplified construction, ease of operation and high accuracy, whereby blood collection, centrifugation and withdrawal of certain phases of the blood can be easily performed by the same device, thereby simplifying complicated operations , the risk of contamination of the blood samples can be reduced and thus the safety of the operating staff can be increased.

 It is a further object of the present invention to provide a blood separation device to substantially improve the process of separating platelet-rich plasma and to increase the efficiency and accuracy of separation.

 According to the above object, the present invention provides a blood separation apparatus comprising: a sleeve having a first end and a second end along an axial direction, wherein a first opening is formed at the first end, and a second opening is formed at the second end ; an inner rod assembly coaxially encircled by the sleeve, whereby the inner rod assembly is reciprocable within the sleeve along the axial direction, the inner rod assembly further including a rod body and a barrel body, wherein the rod body and the barrel body are threadedly interconnected such that the bar body can be optionally removed from the tub body after connection to the tub body; a front cover coaxially disposed with the sleeve at the first end and engaged with the first opening to close the first opening; and a rear cover coaxially disposed with the sleeve at the second end and engaged with the second opening to close the second opening, the rear cover further being provided with a central through-hole such that the bar body extends along the first axial direction through the central through hole and through the second opening and is connected to the tub body.

 According to the above-mentioned blood separation device, the sleeve gradually tapers inward near the first end, thereby forming a socket body portion, the socket body portion being further connected to a needle or an infusion line.

 According to the above-mentioned blood separation device, the back cover is threadedly connected to the second end.

 According to the above-mentioned blood separation device, the edge of the central through-hole contacts with the rod body, so that the rod body is supported by the central through-hole.

According to the above-mentioned blood separation device, the sleeve has an inner side of the sleeve wall and an outer side of the sleeve wall. The tub body has an inner side of the tub wall, an outer side of the tub wall, and a tub bottom area. The outside of the tub wall contacts the inside of the sleeve wall so that the sleeve is from the tub body is sealed. The inside of the tub wall and the tub bottom area together form a receiving space.

 According to the above-mentioned blood separation device, as the materials for the tub body and the sleeve, polyethylene, polypropylene, polycarbonate, silicone, polyurethane, polymethyl methacrylate or a mixture of the above-mentioned materials can be used.

 Brief description of the illustrations

1 shows a schematic perspective view of the blood separation device according to the invention;

2 shows a schematic perspective view of the blood separation device according to the invention;

3 shows a schematic exploded view of the blood separation device according to the invention;

4 shows a schematic cross section of the blood separation device according to the invention;

5 shows a schematic cross section of the front cover of an embodiment of the blood separation device according to the invention;

6A shows a schematic cross section of the tub body of the first embodiment of the blood separation device according to the invention;

6B shows a schematic cross section of the tub body of the second embodiment of the blood separation device according to the invention;

6C shows a schematic cross section of the tub body of the third embodiment of the blood separation device according to the invention;

6D shows a schematic cross section of the tub body of the fourth embodiment of the blood separation device according to the invention;

7A shows a schematic cross section of the tub body of the fifth embodiment of the blood separation device according to the invention;

7B shows a schematic cross section of the tub body of the sixth embodiment of the blood separation device according to the invention;

7C shows a schematic cross section of the tub body of the seventh embodiment of the blood separation device according to the invention;

7D shows a schematic cross section of the tub body of the eighth embodiment of the blood separation device according to the invention;

8th shows a schematic flow diagram of the method for separation of the platelet-rich plasma of the blood separation device according to the invention.

Detailed description of the embodiments

In order to fully understand the objects, technical features and advantages of the present invention to those skilled in the art so that the present invention may be readily accomplished as described, the preferred embodiments will be described in detail below with reference to the figures. The figures in the following text are not necessarily drawn to scale and merely serve to schematically illustrate the features of the present invention. The description of contents in the embodiments known to those skilled in the art will not be repeated here.

 In the first place, the main purpose of the blood separation device according to the invention is the separation of the platelet-rich plasma or the buffy coat in the platelet-rich plasma. However, it will be apparent to those of ordinary skill in the art, with reference to the attached drawings and the following description, that the applicability of the present invention is not limited to platelet-rich plasma only. It may also be used for different blood components or tissue samples that have undergone phase separation by centrifugation. For the sake of a brief description, the device will hereinafter be referred to merely as a "blood separation device".

Referring to 1 and 2 the schematic perspective views of the blood separation device according to the invention 100 and 3 a schematic exploded view of the blood separation device according to the invention 100 shows the exterior of the blood separation device according to the invention 100 an approximately elongated cylindrical shape, which is why the entire blood separation device 100 has an imaginary center axis C. For ease of understanding the description, for the present invention, the spatial orientation of the blood separation device of the invention 100 in advance is defined according to the direction of the central axis C, wherein the longitudinal direction along the central axis C as "axial direction" Y and the transverse direction perpendicular to the central axis C as "radial direction" X are defined. In the following description, by the term "coaxially arranged" in the arrangement manner with respect to all elements, it is meant that the elements are arranged sequentially along the axial direction of the central axis C according to the centrosymmetric point of each element serving as the center. This arrangement will be readily understood by one of ordinary skill in the art and therefore will not be described in detail here.

The blood separation device according to the invention 100 includes a sleeve 30 , an inner pole assembly 10 , a front cover 20 and a back cover 40 , where the sleeve 30 along the axial direction Z, a first end 3001 and a second end 3002 has (see 3 ), being at the first end 3001 a first opening 3100 is formed, wherein at the second end 3002 a second opening 3200 is formed, wherein the first opening 3100 the blood inlet opening of the blood separation device 100 represents, wherein the second opening 3200 after completion of the assembly of the blood separation device 100 is kept in the sealed state by other components, as will be described later in detail.

The sleeve 30 essentially represents a hollow cylinder whose diameter is close to the first end 3001 gradually tapering inwardly, thereby forming a socket body section 320 out, so that the socket body section 320 to the patient's blood in the sleeve 30 be filled, further connected to a needle or other infusion line or in the sleeve 30 collected sample (eg, stratified blood) may be dispensed by the needle or other infusion line for subsequent medical purposes. For the blood separation device of the present invention, commonly used needles, butterfly needles, infusion sets or other corresponding medical devices may be used with the socket body portion 320 are connectable to be used. In addition, the material selection of the sleeve 30 not limited in the present invention. However, in order to achieve a better separation effect, the ability to observe the phase separation of the blood is very helpful in obtaining blood separations, as with the material of the sheath 30 requires a high level of transparency so that the user can control the condition of the blood sample in the sleeve such as As volume, fluid level and positions of the blood phases, easily observe and recognize. Therefore, in the preferred embodiments material is used for the sleeve 30 Polyethylene, high density polyethylene, polypropylene, polycarbonate, silicone, polyurethane, polymethyl methacrylate or a mixture of the above materials in question.

The inner rod assembly 10 becomes coaxial with the sleeve 30 includes, wherein the inner rod assembly 10 and the sleeve 30 not firmly connected to each other so that the inner rod assembly 10 in the sleeve 30 along the axial direction Y is movable back and forth, ie the inner rod assembly 10 is in the hollow tube inside the sleeve 30 arranged and may by an external force along the axial direction Y in the direction of the first end 3001 or towards the second end 3002 be moved, namely in the form of a reciprocating motion. The inner rod assembly 10 further includes a rod body 11 and a tub body 13 , wherein the rod body 11 and the tub body 13 are connected by a thread, whereby the rod body 11 after connection with the tub body 13 optionally again from the tub body 13 can be removed, ie the inner rod assembly 10 consists of a bar body 11 and a tub body 13 wherein the two by a threaded connection with each other stable to a unit, namely the inner rod assembly 10 , are connected, causing the rod body 11 for the reciprocating motion as a part of the driving force for applying force, wherein the tub body 13 the function of the plunger has to get the blood sample into the pod 30 to push. Furthermore, the tub body 13 the function of closing the second opening 3200 to seal the liquid, thus with the blood separation device used 100 the blood sample in the pod 30 is sealed and not from the second opening 3200 flows out, so that even if it experiences a strong force in the process of centrifugation, it comes to no leakage.

According to the preferred embodiments, the rod body 11 and the tub body 13 preferably connected to each other by a threaded connection. The reason for this is that the threaded connection is a widely used but detachable stable connection method. The related manufacturing technique is mature and easy to use, this method being simple in construction and providing a stable connection, thereby increasing the overall structural strength of the inner rod assembly 10 reinforced and the stability of the inner rod assembly 10 while moving in the sleeve 30 can be increased and thus disturbances can be reduced. Further, because threaded connections are easily detachable, the stability of the entire blood separation device becomes 100 if there is a need for disassembly in the separation process, not easily affected by the disassembly, so in particular does not cause interference for the stratified blood become. Therefore, this connection method is also beneficial for the overall result of blood separation.

Referring to 3 and 4 is in 4 a schematic cross section of the blood separation device according to the invention 100 shown. The sleeve 30 includes a sleeve wall 340 , wherein the sleeve wall 340 Furthermore, an inside of the sleeve wall 3402 and an outside of the sleeve wall 3404 having. The side wall 132 of the tub body 13 has an inside of the tub wall 1322 , an outside of the tub wall 1324 and a tub floor area 136 on, with the outside of the tub wall 1324 with the inside of the sleeve wall 3402 contacted to produce a full-surface friction, so that the sleeve 30 from the tub body 13 is sealed, ie the sleeve 30 can by the arrangement of the tub body 13 near the second end 3002 the closed state can be maintained.

However, it should be noted that the tub body 13 , unhindered, that the sleeve 30 from the tub body 13 is sealed in the sleeve 30 still smoothly reciprocated by an external force. Furthermore, form the inside of the tub wall 1322 and the tub floor area 136 together a recording room 130 , This recording room 130 On the one hand, it can be the space in the pod that takes up the blood sample 30 expand the usability of the recording room 130 on the other hand, to ingest a sterile anticoagulant in advance. It is advantageous if the manufacturer in advance an anticoagulant according to the predetermined volume of the blood sample quantitatively into the receiving space 130 filled and this device is the user only then provided directly for blood sampling, whereby the user work steps, namely the preparation step of dosing and retrieving the anticoagulant before blood sampling, be spared and at the same time the risk of contamination during operation is reduced. There are no restrictions on the variety of the above anticoagulant. In accordance with the general knowledge in the art, various choices are available for selecting the type of anticoagulant according to the practical purpose of the blood separation, for example, sodium citrate ("trisodium citrate") is a commonly used anticoagulant for the production of PRP.

From the above description, it can be seen that the tub body 13 in the blood separator 100 has the following functions at the same time: sealing the sleeve 30 (similar function to conventional syringes with a plunger), squeezing the sample and taking the anticoagulant in advance. Sufficient flexibility and mechanical strength should be taken into account in the selection of materials in principle, so that in the preferred embodiments as a material for the tub body 13 Polyethylene, polypropylene, polycarbonate, silicone, polyurethane, polymethylmethacrylate or a mixture of the materials listed above come into question. In a preferred embodiment, high density polyethylene ("HDPE" for short) is particularly preferred and has the following advantages: HDPE is a thermoplastic and is an environmentally friendly material. Polyethylene is easy to process and manufacture, and is well suited for use in the manufacture of various finished products by injection, blowing and extrusion and has little impact on the environment. In terms of mechanical behavior, HDPE has a hard materiality, good flexibility and softness. Furthermore, HDPE has high biocompatibility, high wear resistance, good lubricity, high level of chemical stability and hydrophobicity. HDPE is very suitable for use in the blood separation device 100 to all the above functions of the tub body 13 sure.

The shape of the tub body 13 can be adapted to the needs of the user according to the above functions. Hereinafter, the first to fourth embodiments will be described with reference to FIGS 6A to 6D shown the execution methods of the tub body 13 It should be noted in detail that it should be noted that the bath body according to the invention 13 however, the configurations in the following embodiments are not limited thereto.

First embodiment: Referring to FIG 6A form the inside of the tub wall 1322 and the tub floor area 136 of the tub body 13 a recording room 130 , wherein a second threaded portion 134 from the tub floor area 136 is formed along the axial direction Y and for locking with the rod body 11 serves. The outside of the tub wall 1324 of the tub body 13 protrudes at the end of the opening to the outside, so that a well opening with collar 1320 at the end of the opening of the tub body 13 is formed, whereby the friction between the outside of the tub wall 1324 and the inside of the sleeve wall 3402 can be increased. This configuration can both the tightness between the body of the tub 13 and the sleeve 30 as well as the stability during the reciprocation of the tub body 13 in the sleeve 30 increase. For a brief description of the embodiment method according to the present invention, the configuration of the tub body 13 in the first embodiment of the Description of the blood separation device according to the invention used.

Second embodiment: Referring to FIG 6B is the outside of the tub wall 1324 of the tub body 13a Smooth at the end of the opening, leaving a smooth trough opening 1320a at the end of the opening of the tub body 13 is trained. The other configurations are the same as in the previous first embodiment and will therefore not be described again. The shape of the smooth sink opening 1320a is very easy to manufacture, so if the elasticity and the roughness of the for the body of the tub 13 selected material can be achieved, achieved a desired friction and thereby the functional requirements of the tub body can be met. The design of a smooth tub opening 1320a is advantageous in terms of reducing the manufacturing cost.

Third Embodiment: Referring to FIG 6C is the outside of the tub wall 1324 of the tub body 13b at the end of the opening towards the receiving space 130 inclined inwards, so that an inwardly beveled trough opening 1320b at the end of the opening of the tub body 13 is trained. The other configurations are the same as in the previous first embodiment and will therefore not be described again. The inwardly beveled trough opening 1320b is also easy to make. If the inwardly beveled trough opening 1320b after movement of the blood, the design of the inwardly tapered surface to increase the stability in moving the blood sample is advantageous in order to reduce disturbances. Especially if the user after centrifugation and the phase separation of the blood sample, the inner rod assembly 10 pushes and pulls to remove certain blood phases, is ensured by the aforementioned effect of the interference reduction that the extraction runs exactly and the extraction effect is improved.

Fourth Embodiment: Referring to FIG 6D forms the outside of the tub wall 1324 of the tub body 13c at the end of the opening a recessed position, so a recessed tub opening 1320c at the end of the opening of the tub body 13 is trained. The other configurations are the same as in the previous first embodiment and will therefore not be described again. To the above-mentioned functions of the tub body 13c To ensure, in addition, a first sealing ring 1326 according to the configuration of the recessed tub opening 1320c arranged, this according to the recessed trough opening 1320c is connected to increase the friction and its corresponding effects (sealing effect and anti-slip effect). If the selected material of the tub body 13c is a general plastic, in which the desired friction and tightness can not be easily generated by its physical properties alone, is such an additional arrangement of the first sealing ring 1326 of the present embodiment, so as to meet the functional requirements imposed on the tub body 13c to be fulfilled.

The bar body 11 is by a threaded connection with the tub body 13 locked, whereby the two are separable from each other. Referring to 3 and 4 are in the arrangement of the rod body 11 a first threaded portion 110 , a support section 114 , a blocking element 116 and a handhold section 112 along the axial direction Y from the first end 3001 to the second end 3002 formed sequentially, wherein on the tub body 13 a second threaded section 134 is formed to engage with the first threaded portion 110 to correspond, so that the rod body 11 and the tub body 13 by means of the threaded connection of the first threaded section 110 together with the second threaded portion 134 can be locked, the two can be unscrewed by an operation in the reverse direction to achieve disassembly. Therefore, the rod body can 11 slightly out of the tub body 13 removed and lightly from the sleeve 30 be released for subsequent use. The principle of locking the threaded connection is well known to those skilled in the art, which is why it is not further explained here.

The structural strength of the bar body 11 is through the support section 114 supported. After the connection of the rod body 11 with the tub body 13 can also support the entire inner rod assembly 10 be achieved. The types of bar body 11 are not limited in the scope of the present invention, but need only the requirement of providing the total structural strength for the rod body 11 and for the inner rod assembly 10 fulfill. Thus, it may have a simple rod-shaped configuration (eg, cylinder, hollow rod, prismatic rod). According to a preferred embodiment of the present invention, for forming the support portion 114 several bars 1140 (please refer 1 . 2 and 3 ), so that the inner rod assembly 10 if the support section 114 Forces are absorbed into the sleeve 30 stable to move back and forth. With this configuration, the goal of a lightweight arrangement of the Blood separation device 100 and at the same time achieves the goal of saving manufacturing material.

The blocking element 116 is generally disc-shaped and serves to Ausschiebebegrenzung of the rod body 11 towards the first end 3001 , If the inner rod assembly 10 reaches the predetermined shift range, causes the blocking element 116 a blocking effect, so that the shift range of the inner rod assembly 10 to the length of the sleeve 30 can be adjusted to avoid the results and effects of operation by overly displacing the inner rod assembly 10 be affected.

The hand holding section 112 serves to allow the user's hand to grasp it during operation. The user may apply force to the hand-held section 112 the float of the inner rod assembly 10 cause. To facilitate the operation may further include a pressing element 1120 at the end of the hand holding section 112 be arranged so that the user easily on the inner rod assembly 10 Force, wherein the configuration of the pressing member includes, but is not limited to, wings, discs and support ribs. The specific function of the pressing element 1120 is that when moving the inner rod assembly 10 the depressible area for the fingers is increased and when retracting the inner rod assembly 10 this can be held and exercised on this force.

Referring to 5 is the front cover 20 an embodiment of the blood separation device according to the invention coaxially with the sleeve 30 at the first end 3001 arranged and is with the first opening 3100 engaged to the first opening 3100 close. The front cover 20 serves to close the first opening 3100 so that the blood sample in the blood separator 100 not exposed or leaking, especially the front cover 20 may prevent leakage of the blood sample during centrifugation. To accomplish this purpose, the configuration represents the first opening 3100 the sleeve 30 a front cover 20 ready with a closing function, which is a press-fit part 210 , a first guide section 220 , a second guide section 240 and an inclined guide surface 260 has, wherein the first guide portion 220 and the second guide section 240 are arranged parallel to each other, creating the first opening 3100 towards the interior of the front cover 20 is closed. Referring to 4 the socket body section can 320 the sleeve 30 when assembling the front cover 20 along the inclined guide surface 260 in the interior of the front cover 20 penetrate, with the Einpressteil 210 by the common guidance of the first guide section 220 and the second guide portion 240 in the first opening 3100 is pressed, wherein the first guide section 220 after pressing in the press-fit part 210 continue to hold at the first end 3001 produced to increase the resistance to external forces and to improve the seal.

Referring to 3 and 4 An embodiment according to the present invention is the rear cover 40 together with the sleeve 30 coaxial at the second end 3002 arranged and with the second opening 3200 engaged to the second opening 3200 close. The engagement of the rear cover 40 with the sleeve 30 is achieved by the third threaded section 360 , which at the sleeve 30 at the second end 3002 is formed, and the fourth threaded portion 420 the rear cover 40 bolted together to effect a lock. The back cover 40 is also with a central through hole 410 provided so that the rod body 11 along the axial direction Y through the central through hole 410 and through the second opening 3200 durchsteckt and with the tub body 13 connected is. Inside the central through hole 410 the rear cover 40 is also a guide 4102 trained (see 7A ), for guiding and holding the rod body 11 serves.

In particular, when centrifugation and phase separation are completed, in order to improve blood separation, sample troubles must be avoided as much as possible. The bar body 11 is substantially elongated, whereby in the power and when reciprocating in this instability occur and the sample can be disturbed, which is why a guide 4102 is arranged to the bar body 11 to support and the entire inner rod assembly 10 to stabilize and thus improve the quality of the separation. That is, if the inner rod assembly 10 in the sleeve 30 along the axial direction Y is reciprocated, the rod body 11 through the central through hole 410 and the leadership 4102 largely supported to achieve the effects of positioning, stabilization and leadership.

According to the function of the rear cover 40 subject to the material of the rear cover 40 no particular limitations, including, but not limited to, polyethylene, polypropylene, polycarbonate, silicone, polyurethane, polymethyl methacrylate or a mixture of the materials listed above as material eligible for this. In addition, if there is a desire for manual operation, three-dimensional strips may optionally be provided on the outer wall of the back cover 40 be formed to increase the friction so that power is saved when gripping.

Further, the structural strength of the blood separation device becomes 100 through the back cover 40 reinforced, causing the blood separation device 100 can be used directly for centrifugation. Therefore, the back cover becomes 40 additionally supplemented by the above components, so that blood collection, centrifugation and recovery in the same blood separation device according to the invention 100 are feasible, whereby the operating procedure is simplified and incriminating steps, such. As the replacement of the container and pipetting can be avoided, at the same time the possibility for a attributable to a complicated process contamination risk is reduced. In addition, the directional limitation of the blood separation technique of conventional syringes (for centrifugation, the syringe opening for the blood must be placed facing down, which limits the direction of actuation in the recovery of certain blood phases) and the resulting disadvantages by the blood separation device according to the invention 100 overcome.

According to the above-mentioned function of the rear cover, its configuration can be adapted to the needs of the user. Hereinafter, the fifth to eighth embodiments will be described with reference to FIGS 7A to 7D to describe the embodiment of the back cover in detail, it should be understood that the back cover of the present invention can be seen including, but not limited to, the following embodiments.

Fifth Embodiment: Referring to FIG 7A is the basic structure of the back cover 40 as already described above, constructed as follows: the central through hole 410 the tub body extends inwardly in the direction of the lid body, wherein the inner diameter is reduced and a guide 4102 forms so that the size of the inner diameter of the guide 4102 about the size of the outer diameter of the support portion 114 of the rod body 11 corresponds to, so the rod body 11 from the leadership 4102 can be supported. When used for the blood separation device according to the invention 100 during operation, the need for assembly and disassembly of the rod body 11 , Therefore, the rod body can be 11 when the inner diameter of the central through-hole 410 larger than the inner diameter of the guide 4102 is easily over the central through hole 410 in the sleeve 30 push in or out of the sleeve 30 pull out. The design of the leadership 4102 allows that at the bar body 11 at the same time both the leading and the holding function are guaranteed. In the present embodiment represent the central through hole 410 and the leadership 4102 together in cross-section an inverted T-shape, which is easy to manufacture. For the purpose of a brief description of the embodiment method according to the present invention, only the shape of the rear cover is used 40 described.

Sixth Embodiment: Referring to FIG 7B is the inner diameter of the central through-hole 410a the rear cover 40a essentially equal to the inner diameter of the guide 4102A so that an even easier to manufacture configuration of the rear cover is provided. The other configurations are the same as in the previous fifth embodiment and will therefore not be described again.

Seventh Embodiment: Referring to FIG 7C is the inner diameter of the central through-hole 410b the rear cover 40b larger than the inner diameter of the guide 4102b wherein the central through hole 410b has an inwardly tapered surface, whereby the leading effect for the rod body 11 through the central through hole 410b can be improved. After the bar body 11 in the central through hole 410b is introduced, this is due to the beveled surface in or out of the guide 4102b guided, causing the rod body 11 over the central through hole 410 easy in the sleeve 30 pushed in or out of the sleeve 30 can be pulled out. The other configurations are the same as in the previous fifth embodiment and will therefore not be described again.

Eighth Embodiment: Referring to FIG 7D are the configurations of the central through hole 410c the rear cover 40c and the leadership 4102c substantially the same as those in the fifth embodiment, wherein according to the usage requirements in addition a second sealing ring 4104c can be used whose diameter to the inner diameter of the central through hole 410c adapted, this at the edge of the central through-hole 410c is arranged and with the rod body 11 contacted, reducing the friction and the associated effects of the central through-hole 410c opposite the rod body 11 be raised to the rear cover 40c ensure functional requirements.

To summarize: According to the blood separation device of the present invention, the present invention accordingly provides a simplified and safe method of separating the platelet rich plasma based on the above blood separation device. Since the components, compositions and functions of the blood separation device according to the invention have already been described above, they will not be described again here. However, this includes the two following main modalities with respect to the operation, but is not limited to this: In the first modality, the anticoagulant is used in advance during assembly of the blood separation device in the tub body; In the second modality, the anticoagulant is used only prior to application according to the needs of the user.

In the following, the first modality in which the anticoagulant is inserted in advance in the assembly of the blood separation device into the well body will be described, referring to the method of separating the platelet rich plasma 8th following steps include:

Step S1: Remove the front cover 20 and inserting a needle 501 at the first end 30 the sleeve 501 , By means of the already with a needle 501 equipped blood separation device is the patient blood B taken, the blood B after insertion into the sleeve 30 completely mixed with the anticoagulant immediately. After that, the needle becomes 501 removed and then the front cover 20 placed on the first opening to close the first opening.

Step S2: Remove the rod body 11 , The bar body 11 gets from the tub body 13 removed, the rod body 11 from the central through hole of the rear cover 40 pulled out and then with a front cover 20 is provided to close the first opening.

 Step S3: Centrifuge the blood separation device. The blood separation device is centrifuged with the second end facing the direction of gravity Z, whereby the blood B is stratified. The stratified blood B has several phases. Starting from the first end to the second end, this contains sequentially a plasma layer of small amount of platelets L1, a platelet-rich plasma layer L2, a buffy coat L3 and an erythrocyte layer L4.

Step S4: Inserting the rod body 11 in the sleeve 30 via the central through-hole and connecting it to the tub body 13 through a thread. Accordingly, this combination can again serve as a functional inner rod assembly, then the rod body 11 pushed and thereby the inner rod assembly 10 inside the sleeve 30 driven to reciprocate, thereby causing the above-mentioned stratified blood in the sleeve to move, thereby regulating the positions of the phases so that all the phases from the first opening are let out sequentially. Upon letting go of all phases, the user can selectively absorb the phases (the platelet-rich plasma layer L2 and the buffy coat L3) through a needle located at the first end of the sleeve 30 is inserted through an infusion line 502 or directly through a suitable container to remove the platelet rich plasma layer L2, the buffy coat L3 or both at the same time, using an infusion line 502 is used, an infusion line 502 is used according to a preferred embodiment with an infusion line with a butterfly needle, the targeted stratified blood is injected directly back into the affected area in the patient. Operation is comfortable and the risk of contamination is reduced. Further, according to another embodiment, the user may use an adapter with bidirectional through holes, one end of which with the sleeve 30 and the other end is connected to a suitable infusion line or container (e.g., sterile empty syringe) to stably connect the two together and at the same time to ensure passage of the blood in the line, whereby certain blood phases (e.g. the platelet-rich plasma layer L2 and the buffy coat L3) from the sleeve 30 into the infusion line 502 or in a suitable container.

 The other modality, in which the anticoagulant is used only before the application according to the needs of the user, has the same method and operations as in the above first modality. The only difference is that the user must dose and remove an appropriate amount of the anticoagulant before taking the blood.

The invention thus relates to a blood separation device, comprising: a sleeve having a first end and a second end, wherein at the two ends in each case a first opening and a second opening is provided; an inner rod assembly coaxially encircled by the sleeve, whereby the inner rod assembly is reciprocally movable in the sleeve along the axial direction, the inner rod assembly further including a rod body and a barrel body, the two being threadably connected to each other Rod body can be removed optionally after connection with the tub body; a front cover coaxially disposed with the sleeve at the first end to enclose the first opening and thereby close the first opening; and a rear cover coaxially disposed with the sleeve at the second end to cover the second opening and thereby close the second opening, the rear cover being provided with a central through-hole such that the rod body passes through the central through-hole and connected to the tub body. The present invention provides an apparatus and method that is simple, practical, and reliable to separate the platelet-rich plasma.

 The above description represents only preferred embodiments of the invention and is not intended to limit the claims. All equivalent changes and modifications that can be made according to the description and the drawings of the invention by a person skilled in the art fall within the scope of the present invention. The scope of the invention is determined by the appended claims.

LIST OF REFERENCE NUMBERS

10

Internal rod assembly

11

rod body

13

when body

20

front cover

30

shell

40

rear cover

100

Blood separation device

110

first threaded section

112

Hand holding section

114

support section

116

blocking element

130

accommodation space

132

Side wall

134

second threaded section

136

When the floor area

210

pressed-in

220

first guide section

240

second guide section

260

sloping guide surface

320

Socket body section

340

sleeve wall

360

third threaded section

410

central through hole

420

fourth thread section

1120

press member

1140

web

1320

Trough opening with collar

1322

Inside of the tub wall

1324

Outside of the tub wall

1326

first sealing ring

3001

first end

3002

second end

3100

first opening

3200

second opening

3402

Inside of the sleeve wall

3404

Outside of the sleeve wall

4102

guide

1320a

smooth trough opening

1320b

inwardly beveled trough opening

1320c

recessed tub opening

4102A

guide

4102b

guide

4102c

guide

4104c

second sealing ring

410a

central through hole

410b

central through hole

410c

central through hole

501

needle

502

infusion line

B

blood

C

central axis

L1

Plasma layer of platelets

L2

Platelet-rich plasma layer

L3

Buffy coat

L4

erythrocytes layer

S1, S2, S3, S4

steps

X

radial direction

Y

axial direction

Z

The direction of gravity

QUOTES INCLUDE IN THE DESCRIPTION

This list of the documents listed by the applicant has been generated automatically and is included solely for the better information of the reader. The list is not part of the German patent or utility model application. The DPMA assumes no liability for any errors or omissions.

Cited patent literature

• CN 202478263 U [0007]
• CN 201469752 U [0007]

Claims (7)

 A blood separation device for separating platelet-rich plasma comprising: a sleeve having a first end and a second end along an axial direction, a first opening being formed at the first end, a second opening being formed at the second end, an inner rod assembly coaxially encircled by the sleeve whereby the inner rod assembly is reciprocally movable within the sleeve along the axial direction, the inner rod assembly further including a rod body and a barrel body, wherein the rod body and the barrel body are threadedly interconnected such that the bar body can be optionally removed from the tub body after connection to the tub body, a front cover coaxially disposed with the sleeve at the first end and engaged with the first opening to close the first opening, and a rear cover coaxially disposed with the sleeve at the second end and engaged with the second opening to close the second opening, the rear cover further being provided with a central through-hole, so that the bar body along the axial Direction through the central through hole and through the second opening and is connected to the tub body.  A blood separator according to claim 1, wherein the sleeve gradually tapers inwardly near the first end thereby forming a socket body portion, the socket body portion being further connected to a needle or infusion line.  A blood separation device according to claim 1, wherein the rear cover is threadedly connected to the second end.  The blood separation device of claim 1, wherein the edge of the central through-hole contacts the rod body so that the rod body is supported by the central through-hole.  The blood separation device of claim 1, wherein the sleeve has an inner side of the sleeve wall and an outer side of the sleeve wall, the well body having an inner side of the well wall, an outer side of the well wall and a tub bottom portion, the outer side of the well wall contacting the inner side of the sleeve wall the sleeve is sealed by the tub body, wherein the inside of the tub wall and the tub bottom portion together form a receiving space.  A blood separation device according to claim 1, wherein as materials for the tub body polyethylene, polypropylene, polycarbonate, silicone, polyurethane, polymethylmethacrylate or a mixture of the above-mentioned materials come into question.  A blood separation device according to claim 1, wherein suitable materials for the sleeve are polyethylene, high density polyethylene, polypropylene, polycarbonate, silicone, polyurethane, polymethylmethacrylate or a mixture of the above materials.

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