TWM589033U - Blood separation assembly and blood separation tube - Google Patents

Abstract

The present invention discloses a blood separation tube, which includes a blood vessel, a separation gel, and a cover. The blood storage vessel has a closed end, an open end opposite to the closed end, and a blood storage space. The separation gel is placed in the blood storage space, wherein the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and 1.093. The cover and the open end of the blood vessel are separably and tightly combined. In this way, platelet-rich plasma, platelet-rich fibrin, or platelet lysate can be quickly separated in the same blood separation tube. The present invention also discloses a blood separation assembly, which includes a blood collection device and the aforementioned blood separation tube.

Description

Blood separation assembly and blood separation tube

This creation relates to a separation tube, in particular to a blood separation tube. This creation also relates to a blood separation assembly including the aforementioned blood separation tube.

With the advancement of regenerative medicine, the use of stem cells and growth factors to promote the repair and regeneration of cell tissues to achieve therapeutic effects is becoming increasingly mature.

Among them, platelet-rich plasma (PRP), also known as high-concentration platelet plasma, is obtained by centrifuging whole blood, and its main effective component is platelets. After activation, platelets will release many granules with different functions, mainly growth factors, which can stimulate cell proliferation and cell differentiation, and have very good results in alleviating tissue inflammation and promoting cell tissue repair and proliferation. Platelet-rich plasma has clinical applications in the field of sports medicine. For example, it is used to treat soft tissue injuries of professional athletes. It can also be used in medical aesthetics and dentistry. In addition, the preparation of platelet-containing plasma is usually prepared by collecting autologous blood, so there is no rejection reaction of non-autologous tissue.

In addition, platelet-rich fibrin (PRF), which is called second-generation PRP, is jelly-like and has better plasticity. It is often used in conjunction with bone meal to be used in alveolar bone regeneration surgery, or will be rich in After platelet fibrin is compressed into a film, it is used in periodontal regeneration surgery.

Compared with the previous two, platelet lysate (PL) removes platelet membranes, fibrin and cell debris, etc., which can minimize the immune response and at the same time Retain growth factors. Studies have shown that platelet lysate can significantly promote bone regeneration and repair; in addition, the combination of platelet lysate and autologous bone marrow mesenchymal stem cells can accelerate the rate of bone formation.

However, the treatment of platelet-rich plasma, platelet fibrin, and platelet lysate is usually taken immediately after separation, and research indicates that the residual red blood cells may cause pain and inflammation in the recipient. Therefore, how to quickly and effectively separate platelet-rich plasma, platelet-rich fibrin, or platelet lysate with high concentration of active ingredients is an urgent problem to be solved in the technical field.

The technical problem to be solved by this creation is to provide a blood separation component and a blood separation tube that can quickly prepare platelet-rich plasma or platelet lysate in the same separation container for the shortcomings of the prior art, and has High red blood cell removal rate.

In order to solve the above technical problems, one of the technical solutions adopted in this creation is: a blood separation tube, which includes a blood vessel, a separation gel, and a cover. The blood vessel has a closed end, an open end opposite to the closed end, and a blood storage space communicating with the open end, wherein the open end is used to place a whole blood in the blood storage space . The separation gel is disposed in the blood storage space of the blood storage vessel, wherein the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and 1.093 for use in a centrifugal condition Next, the whole blood is divided into a red blood cell layer below the separation gel, a skin color blood cell layer above the separation gel, and a plasma layer above the skin color blood cell layer. The cover body is detachably covered on the open end to seal the blood storage space.

In order to solve the above technical problems, another technical solution adopted in this creation is: a blood separation component, which includes a blood collection device and a blood substance separation colloid. The blood separation tube includes a blood vessel, a separation gel, and a cover. The storage vessel has a closed end, an open end relative to the closed end, and a The blood storage space communicating with the open end, wherein the open end is used to place a whole blood in the blood storage space. The separation gel is disposed in the blood storage space of the blood storage vessel, wherein the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and 1.093 for use in a centrifugal condition Next, the whole blood is divided into a red blood cell layer below the separation gel, a skin color blood cell layer above the separation gel, and a plasma layer above the skin color blood cell layer. The cover body is detachably covered on the open end to seal the blood storage space.

One of the beneficial effects of this creation is that the blood separation assembly and blood separation tube provided by this creation can pass through "the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and 1.093 "Technical features to quickly separate platelet-rich plasma or platelet lysate in the same container.

In order to further understand the characteristics and technical content of this creation, please refer to the following detailed description and drawings of this creation. However, the drawings provided are for reference and explanation only, and are not intended to limit this creation.

S100~S108‧‧‧Step

1‧‧‧blood separation tube

11‧‧‧Reservoir

111‧‧‧Closed end

112‧‧‧Open end

113‧‧‧Blood storage space

12‧‧‧ Separating glue

13‧‧‧cover

2‧‧‧ Whole blood

21‧‧‧ Red blood cell layer

22‧‧‧Blood cell layer

23‧‧‧ plasma layer

24‧‧‧ platelet-rich plasma

241‧‧‧ Upper separation liquid

242‧‧‧Lower separation liquid

30‧‧‧syringe

40‧‧‧Shape

Figure 1 is a side view of the blood separation tube created by the author.

2 is a flowchart of a method for separating blood using the blood separation tube of the present invention.

FIG. 3 is a schematic diagram of step S100 in FIG. 2.

FIG. 4 is a schematic diagram of completing step S102 in FIG. 2.

FIG. 5 is a schematic diagram of completing step S104 in FIG. 2.

FIG. 6 is a schematic diagram of step S106 in FIG. 2.

FIG. 7 is a schematic diagram of completing step S108 in FIG. 2.

In recent years, due to the increasing demand for autologous growth factor regeneration therapy, how to effectively and quickly separate high concentrations of platelet-rich plasma (PRP) and platelet-rich fibrin (PRF) With platelet lysis Liquid (platelet lysate, PL) is urgently needed. In addition, it is necessary to ensure that during the course of autogenous regeneration, patients will not have pain or inflammation caused by the red blood cells remaining in PRP, PRF or PL. Therefore, the blood separation assembly and blood separation tube provided by the present invention can quickly and efficiently prepare platelet-rich plasma or platelet lysate directly in the same separation container.

The following is a specific specific example to illustrate the implementation of the "blood separation assembly and blood separation tube" disclosed in this creation. Those skilled in the art can understand the advantages and effects of this creation by the content disclosed in this specification. This creation can be implemented or applied through other different specific embodiments. The details in this specification can also be based on different views and applications, and various modifications and changes can be made without departing from the concept of this creation. In addition, the drawings in this creation are only a schematic illustration, not based on actual size, and are declared in advance. The following embodiments will further describe the relevant technical content of the creation, but the disclosed content is not intended to limit the protection scope of the creation.

It should be understood that although terms such as “first”, “second”, and “third” may be used herein to describe various elements or signals, these elements or signals should not be limited by these terms. These terms are mainly used to distinguish one component from another component, or one signal from another signal. In addition, the term "or" as used herein may include any combination of any one or more of the associated listed items, depending on the actual situation.

Please refer to FIG. 1, this creation provides a blood separation tube 1, which mainly includes a blood storage vessel 11, a separation gel 12 and a cover 13.

The blood storage vessel 11 is a rigid tube having a closed end 111, an open end 112 opposite to the closed end 111, and a blood storage space 113 communicating with the open end 112. The open end 112 of the blood storage vessel 11 is used to place a whole blood in the blood storage space 113. For example, the material of the blood storage vessel 11 may be transparent or translucent plastic or glass, so that the blood layering can be clearly seen during use, but not limited to this. In addition, blood storage The closed end 111 of the tube 11 may have a round bottom shape, so that the storage vessel 11 can concentrate the sample on the bottom of the tube when in use, but not limited to this. The outer wall surface of the storage vessel 11 may have multiple scale marks, so that when in use, it can directly identify the internal volume.

The separating gel 12 is placed in the blood storage space 113 of the blood storage vessel 11, for example, at a position near the closed end 111. It is worth noting that the separation gel 12 contains a silicon-containing polymer, and the specific gravity of the separation gel 12 is between 1.030 and 1.093, but is not limited thereto. In this embodiment, the separation gel 12 may contain other components as needed, such as a thixotropic agent and a non-toxic inert organic lubricant. In detail, the thixotropic agent is used to adjust the viscosity of the separating glue. The physical properties of the separation gel 12 are shown in Table 1 below:

The cover 13 is detachably and tightly engaged with the open end 112 of the storage vessel 11 to expose or close the open end 112. Further, the cover 13 may be a spiral cap, a plastic cap, a safety cap, or a rubber cap, but it is not limited thereto.

For example, the blood separation tube 1 may be a plastic centrifuge tube or a glass centrifuge tube, but it is not limited thereto.

In addition, the present invention also provides a blood separation assembly, which includes a blood collection device and a blood separation tube 1 that is separated from the blood collection device. The blood collection device may be a blood collection device known in the medical field, for example, a blood collection syringe. In its administration state, after collecting a whole blood from a mammal (for example, a human) using a blood collection device, the blood is transferred into the blood separation tube 1 under sterile conditions, and the blood separation tube 1 can be placed Centrifuge in a centrifuge. In addition, the blood separation tube 1 can be placed in a centrifuge to directly perform the centrifugation operation.

FIG. 2 is an example of the operation method of the created blood separation tube 1, which mainly includes: step S100, placing a whole blood in the blood separation tube 1; step S102, centrifuging using the first effective speed to divide the whole blood into Red blood cell layer, skin color blood cell layer and plasma layer; and Step S104, mixing skin color blood cell layer and plasma layer to obtain platelet rich plasma.

Further, as shown in step S106, the platelet-rich plasma obtained in the blood separation tube 1 can be taken out to coagulate, thereby forming platelet-rich fibrin.

Alternatively, as shown in step S108, a second effective rotation speed is further used to perform a multi-stage centrifugal blood separation tube 1 to form platelet-rich plasma into a platelet lysate.

It is worth noting that the platelet-rich plasma obtained in step S104, the platelet-rich fibrin obtained in step S106, and the platelet lysate obtained in step S108 are all prepared using the blood separation tube 1 of the present creation The target product. In the following, please refer to FIG. 2 to describe in detail the method of separating each target product.

Example 1 Preparation of Platelet-Rich Plasma (PRP)

In this embodiment, the whole blood may be collected from the autologous blood of the mammal through the blood collection device. Therefore, after obtaining the autologous regeneration substance (for example: platelet rich plasma, platelet fibrin rich, platelet lysate) It should be used in the course of autologous treatment without causing rejection of immune response.

Please refer to step S100 in FIG. 2 and in conjunction with FIG. 3, place a whole blood 2 in the blood separation tube 1. Referring to FIG. 3 again, in this embodiment, first, 10 ml of the recipient’s whole blood 2 is collected into the aforementioned blood separation tube 1. Generally speaking, the separation gel 12 is the bottom filled in the storage vessel 11, and the thickness is greater than 5 mm, but not limited to this. The whole blood 2 can be collected by collecting the whole blood 2 from a mammal (eg, a human) via a blood collection device, and then placing the whole blood 2 into the blood separation tube 1 in a sterile environment.

Next, as shown in step S102 shown in FIG. 2, centrifugation is performed using the first effective rotation speed. In this embodiment, the blood separation tube 1 containing the whole blood 2 is centrifuged at a first effective speed. The first rotation speed may be between 3000 rpm and 4000 rpm. The centrifugation time may be between 3 minutes and 10 minutes, but not limited thereto. After centrifugation, as shown in FIG. 4, the blood separation tube 1 will have a red blood cell layer 21, a separation gel 12, a buffy coat layer 22 and a blood plasma layer from bottom to top )23, a total of four separation layers.

The main content of the red blood cell layer 21 is red blood cells, which accounts for about 40% of the total volume of whole blood 2, and is responsible for the transportation of oxygen and carbon dioxide. In the whole blood 2, the specific gravity of only the red blood cells is greater than the specific gravity of the separation gel 12, therefore, during centrifugation, only the red blood cells can pass through the separation gel 12 and precipitate in the lowermost layer of the blood separation tube 1, so that the separation gel 12 is located in the red blood cell layer 21 Between the blood cell layer 22 of the skin color, that is, the separating gel 12 isolates the red blood cell layer 21.

The main contents of the skin-colored blood cell layer 22 are nucleated cells (such as stem cells and white blood cells, etc.) and platelets, which account for about 5% of the total blood volume. The main content of the plasma layer 23 is the serum component of whole blood, which accounts for about 55% of the total volume of the whole blood. The plasma layer 23 contains water and many proteins, such as antibodies, enzymes, hormones, etc.

Finally, as shown in step S104 of FIG. 2, the skin layer blood cell layer 22 and the plasma layer 23 are mixed to obtain platelet-rich plasma 24. In the blood separation tube 1, the skin-colored blood cell layer 22 and the plasma layer 23 are mixed to obtain a platelet-rich plasma 24 (as shown in FIG. 5 ).

Furthermore, before mixing the blood cell layer 22 of the skin color and the plasma layer 23, 1% to 90% by volume of the total volume of the plasma layer 23 can be taken out, and a part of the plasma layer 23 can be retained, so that a high concentration can be finally obtained in step S104 1.3 to 25 times the platelet-rich plasma24. For example, after removing 5 ml of the plasma layer 23 that was originally centrifuged, 4 ml is retained, and after retaining about 1 ml of the plasma layer 23, the skin layer 22 and blood The slurry layer 23 is mixed to obtain a concentrated platelet-rich plasma 24, but not limited thereto. For example, during the operation, the doctor will evaluate the total amount of PRP to be administered based on the affected part, and then push back the remaining amount of plasma layer 23 required.

It is worth noting that the separation gel 12 will not be turned upside down with the blood separation tube 1 tilted upside down. Therefore, the blood separation tube 1 of this creation can be moved directly into the blood separation tube 1 without being transferred to another container. The skin layer blood cell layer 22 and the plasma layer 23 are mixed to obtain platelet-rich plasma 24. The mixing method may be to use an electric pipette aid or a micro-dispenser to repeatedly suck and mix, or to close the lid 13 of the blood separation tube 1 and tilt the ends of the blood separation tube 1 repeatedly. During the mixing, the red blood cell layer 21 will not be mixed into the platelet-rich plasma 24 due to the inclination of the separating gel 12 during the mixing process.

Studies have pointed out that when red blood cells remain in autologous regeneration substances (for example: platelet-rich plasma, platelet fibrin, and platelet lysate), it may cause pain and inflammation in patients. However, in general, centrifuge tubes can only stratify whole blood, so the red blood cell layer will be next to the skin blood cell layer, and part of the skin blood cell layer must be discarded to avoid taking red blood cells, which leads to a lower content of platelets. In other words, if you want to get platelet-rich plasma with high platelet content, you need to remove the plasma layer and the blood cell layer of the skin color as much as possible. In the process, red blood cells may be taken, so the residual rate of red blood cells and the side effects of the receptor The risk will also be higher. In addition, because the red blood cell layer is next to the skin color blood cell layer, the plasma layer and the skin color blood cell layer need to be taken out to another container before they can be mixed, thereby increasing the operation steps and working time, and the blood separation tube of this creation only needs no The operation steps of 10 minutes can complete the preparation of autologous platelet-rich plasma.

It is worth noting that since anticoagulants will inhibit the activation of platelets, when platelets are in an inactive state, the production of growth factors secreted by platelets will be greatly reduced. The blood separation tube 1 of this creation does not contain anticoagulant, so compared to the centrifuge tube or vacuum blood collection tube containing anticoagulant, the platelet-rich plasma prepared by the blood separation tube 1 of this creation , Rich in platelet fibrin and rich The concentration of growth factors in platelet-containing lysate can be 2.6 to 13 times higher.

Example 2 Preparation of Platelet-Rich Fibrin (PRF)

Referring to step S106 shown in FIG. 2, the platelet-rich plasma is removed from the blood separation tube 1 and allowed to clot to form platelet-rich fibrin. As shown in FIG. 6, the platelet-rich plasma 24 prepared by Preparation 1 is taken out using a syringe 30 and placed in a shaped dish 40, and left to stand for a period of time, which is based on the patient’s physical condition and previous medication Depending on the effect, it is generally 15 to 45 minutes, but not limited to this; platelet-rich plasma 24 will naturally coagulate, and platelet-rich fibrin can be obtained. Furthermore, a platelet-rich fibrin membrane can be obtained by squeezing platelet-rich fibrin using sterile gauze.

Furthermore, the platelet-rich fibrin can also be prepared by using concentrated platelet-rich plasma 24.

It is worth noting that the shape of the shaped dish 40 can be adjusted according to the needs of surgery or application, so that the platelet-rich fibrin can be shaped along with the shape of the shaped dish 40. Therefore, the application of platelet-rich fibrin in medical surgery is very widely.

Example 3 Preparation of Platelet Lysate (PL)

Platelet lysate is the liquid part of platelets after lysis. It retains many growth factors and removes platelet membranes and other cell debris, which can further reduce the immune response generated during transplant regeneration.

Referring to step S108 shown in FIG. 2, a second effective speed is used to perform a multi-stage centrifugation to form platelet-rich plasma into a platelet lysate. The platelet-rich plasma 24 prepared in Preparation 1 is retained in the blood separation tube 1 and centrifuged in multiple stages to separate the platelet-rich plasma 24 into an upper separation liquid 241 and a lower separation liquid 242 (as shown in FIG. 7). The upper separation liquid 241 is platelet lysate, and the lower separation liquid 242 contains platelet fibrin, platelet membrane, and other cell debris.

In detail, the second effective rotation speed in the multi-stage centrifugation may be between 3500 rpm and 4500 rpm, and the centrifugation time may be between 3 minutes and 15 minutes, but not limited to this. And the multi-stage centrifugation includes performing intermittent centrifugation at a predetermined interval, for example, repeating centrifugation 5 to 15 times according to the second effective speed. Since the number of repeated centrifugation will actually be adjusted according to individual differences, the number of repeated centrifugation is based on whether the platelet-rich plasma 24 produces upper and lower separation liquids.

[Target product application note]

Platelet-rich plasma, platelet-rich fibrin, and platelet lysate obtained using the blood separation tube created by this creation are rich in many growth factors, and can be used for regeneration in dentistry, orthopedics, rehabilitation, medical aesthetics, obstetrics and gynecology, etc. In therapy.

Further, the growth factors include: insulin-like growth factor (IGF), keratinocyte growth factor (KGF), epidermal growth factor (EGF), transforming growth factor (transforming growth factor, TGF), fibroblast growth factor (FGF), vascular endothelial growth factor (VEGF), platelet derived growth factor (PDGF), and connective tissue growth Factor (connective tissue growth factor, CTGF), etc., but not limited to this. The main functions of the above growth factors include stimulating cell proliferation, stimulating cell migration, helping wound healing, promoting angiogenesis, and promoting collagen secretion.

For example, the patient can separate the blood by using the blood separation tube created by the author to obtain autologous platelet-rich plasma, mix it with hyaluronic acid, and inject it into the patient's dermal layer and subcutaneous layer, so as to modify the face and The effect of eliminating static wrinkles.

For another example, a patient with alveolar bone atrophy can separate the blood by using the blood separation tube created by the author to obtain autologous platelet-rich fibrin. Pick up After the bone powder was taken from platelet-rich fibrin, it was filled into the alveolar bone of the patient to help osteoblast proliferation and accelerate wound healing.

For another example, a patient suffering from arthritis can separate the blood by using the blood separation tube created by the author, and obtain the autologous platelet lysate, and then directly inject the affected part to treat arthritis, so that the arthritis can obtain improve.

[Beneficial effect of embodiment]

One of the beneficial effects of this creation is that the blood separation assembly and blood separation tube provided by this creation can pass through "the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and 1.093 "Technical features to quickly separate platelet-rich plasma or platelet lysate in the same container.

The content disclosed above is only a preferred and feasible embodiment of this creation, and does not limit the scope of the patent application for this creation, so any equivalent technical changes made by using this creation specification and graphic content are included in this creation application Within the scope of the patent.

1‧‧‧blood separation tube

11‧‧‧Reservoir

111‧‧‧Closed end

112‧‧‧Open end

113‧‧‧Blood storage space

12‧‧‧ Separating glue

13‧‧‧cover

Claims (20)

A blood separation tube includes: a blood vessel having a closed end, an open end opposite to the closed end, and a blood storage space communicating with the open end, wherein the open end is used to place a Whole blood in the blood storage space; a separation gel, which is arranged in the blood storage space of the blood vessel, wherein the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and Between 1.093, used to divide the whole blood into a red blood cell layer under the separation gel, a skin blood cell layer above the separation gel, and a blood plasma layer above the skin color blood cell under a centrifugal condition Layer; and a cover, which is detachably covered on the open end for sealing the blood storage space. The blood separation tube according to claim 1, wherein the separation gel is located close to the closed end. The blood separation tube according to claim 1, wherein the viscosity of the separation gel is less than 40×10 ⁴ mPa. s. The blood separation tube according to claim 3, wherein the separation gel further contains a thixotropic agent, a lubricant, or any combination thereof. The blood separation tube according to claim 1, wherein the material of the blood reservoir is plastic or glass. The blood separation tube according to claim 1, wherein the closed end of the blood storage vessel has a round bottom shape. The blood separation tube according to claim 1, wherein the outer wall surface of the storage vessel has a plurality of scale marks. The blood separation tube according to claim 1, wherein the cover is a spiral tube cap, a plastic cap, a safety cap, or a rubber cap. The blood separation tube according to claim 1, wherein the skin-colored blood cell layer and the plasma layer above the separation gel are mixed to form a platelet-rich plasma. The blood separation tube according to claim 1, wherein the centrifugation condition includes a first effective rotation speed and a centrifugation time, the first effective rotation speed is between 3000 rpm and 4000 rpm, and the centrifugation time is between 3 and 10 minutes . The blood separation tube according to claim 9, wherein the platelet-rich plasma located above the separation gel can further form a platelet lysate under a multi-stage centrifugation condition. The blood separation tube according to claim 11, wherein the multi-stage centrifugation condition includes using a second effective rotational speed to perform multiple centrifugations at every predetermined time interval. The blood separation tube according to claim 12, wherein the second effective rotation speed is between 3500 rpm and 4500 rpm, the total number of centrifugations is 5 to 15 times, and the time for each centrifugation is between 3 to 15 minutes. A blood separation assembly, comprising: a blood collection device for collecting a whole blood from a mammal; and a blood separation tube, which is separated from the blood collection device, wherein the blood separation tube includes: a storage The blood vessel has a closed end, an open end opposite to the closed end, and a blood storage space communicating with the open end, wherein the open end is used to place the whole blood in the blood storage space; A separation gel, which is arranged in the blood storage space of the blood storage vessel, wherein the separation gel contains a silicon-containing polymer, and the specific gravity of the separation gel is between 1.030 and 1.093, used for centrifugation Conditionally, the whole blood is divided into a red blood cell layer below the separation gel, a skin color blood cell layer above the separation gel, and a plasma layer above the skin color blood cell layer; and a lid, which can It is detachably covered on the open end to seal the blood storage space. The blood separation assembly according to claim 14, wherein the separation gel is located near the closed end. The blood separation module according to claim 14, wherein the viscosity of the separation gel is less than 40×10 ⁴ mPa. s. The blood separation assembly according to claim 16, wherein the separation gel further contains a thixotropic agent, a lubricant, or any combination thereof. The blood separation assembly according to claim 14, wherein the material of the blood vessel is plastic or glass. The blood separation assembly according to claim 14, wherein the closed end of the blood reservoir is round-bottomed, and the outer wall surface of the blood reservoir has a plurality of scale marks. The blood separation assembly according to claim 14, wherein the cover is a spiral tube cap, a plastic cap, a safety cap, or a rubber cap.

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