Blood separation device

Abstract

A blood separation device includes a container defining an internal space, a separator movably disposed within the internal space and in sealed contact with the container, and an infusion tube. The separator divides the internal space into an actuating chamber and a reservoir chamber. A flow channel is formed in the separator connecting the actuating chamber and the reservoir chamber. One end of the infusion tube is connected to the flow channel, and the other end extends out of the internal space. This invention allows for two centrifugations after blood is contained, extracting the platelet-rich erythrocyte sedimentation rate (ESR) layer without changing the container. Furthermore, the red blood cell layer is discharged from the reservoir chamber via Pascal's principle, ensuring the blood is not affected by eddy currents and can be output while maintaining a flat liquid surface.

Description

[Technical Field]

[0001] This invention relates to a container for centrifugation, and more particularly to a blood separation device for extracting high concentrations of autologous platelet plasma. [Previous Technology]

[0002] Human blood is mainly composed of plasma and formed elements, which refer to red blood cells, white blood cells, and platelets. When blood is centrifuged at a certain rate, the formed elements will settle into layers in the plasma according to their different specific gravities. Red blood cells have the highest specific gravity and therefore settle at the bottom; plasma contains no cells and has the lowest specific gravity, so it is located at the top of the layer; white blood cells and platelets have specific gravities between red blood cells and plasma, commonly known as the erythrocyte sedimentation rate (ESR) buffy coat, and are located between red blood cells and plasma. Because platelets in blood can be used for high-value applications such as regenerative injections, various extraction methods are currently available and widely used, including colloid centrifugation, single centrifugation, and double centrifugation. Compared to colloid centrifugation and single centrifugation, double centrifugation can provide a higher concentration of platelets. Double centrifugation refers to the method of extracting high-concentration autologous platelet-rich plasma (PRP) by centrifuging blood twice. This method first involves placing blood into a blood separation container. After centrifugation, the blood will roughly separate into an upper plasma layer and an erythrocyte sedimentation rate (ESR) layer, and a lower red blood cell layer. Next, the upper plasma layer and ESR layer are carefully drawn from above using a syringe and injected into another blood separation container. After a second centrifugation, the ESR layer settles to the bottom. Then, using another syringe, the plasma layer with the lowest specific gravity is drawn from above, and finally, the remaining platelet-rich plasma is drawn using yet another syringe. However, this method requires multiple extractions and injections to transfer blood. Besides being cumbersome and time-consuming, the increased number of transfers also raises concerns about blood contamination.

[0003] Referring to Figure 1, Republic of China Utility Model Patent No. M598150 discloses a centrifuge container 1, which includes a body 11 surrounding an internal space 111, a connecting tube 12 connected to the bottom of the body 11 and communicating upward with the internal space 111, a cover 13 covering the body 11 to close the internal space 111, and a sealing cap 14 disposed at the end of the connecting tube 12. The opening at one end of the connecting tube 12 communicates with the bottom of the internal space 111, while the opening at the other end is closed by the sealing cap 14. The centrifuge container 1 is first filled with blood and centrifuged for the first time. After centrifugation, the blood is separated into layers that are distinguishable to the naked eye: a plasma layer A, a red blood cell layer B, and a brownish-yellow erythrocyte sedimentation rate layer C. Then, the sealing cap 14 is removed, and the red blood cell layer B, located at the bottom of the blood, is extracted from the internal space 111 by suction. Then the centrifuge container 1 can be centrifuged a second time, and the aforementioned steps can be repeated to extract the bottom layer of platelet-rich erythrocyte sedimentation rate (ESR) layer C through a syringe.

[0004] However, even if the red blood cell layer B is emptied before the second centrifugation, due to the eddy current effect, the blood, which was originally stratified according to specific gravity, will be mixed during the emptying process due to the instability of the water flow and the vortex structure, making it impossible to separate the heaviest red blood cells. This causes the integrity of the liquid layer to be broken after the liquid level drops, resulting in some of the lighter white blood cells and platelets being discharged from the space 111 along with the red blood cells due to the eddy current effect, affecting the extraction concentration. In addition, when the red blood cell layer B is emptied, there will be adhering red blood cells on the inner wall of the body 11. The erythrocyte sedimentation rate (ESR) brownish-yellow layer C containing platelets and white blood cells will come into contact with the aforementioned area during the second centrifugation process, causing red blood cells to mix into the aforementioned ESR brownish-yellow layer C containing platelets, resulting in increased discomfort for patients after injection. The above two reasons affect the extraction concentration and the mixing of red blood cells, so there is still room for improvement. [Summary of the Invention]

[0005] Therefore, the object of the present invention is to provide a blood separation device that can improve the above-mentioned conventional problems.

[0006] Therefore, the blood separation device of the present invention includes a container that defines an internal space and has a perforation communicating with the internal space, a partition movably disposed in the internal space and in sealed contact with the container, and an infusion tube. The partition divides the internal space into an actuating chamber that is directly connected to the perforation and a reservoir chamber that is not directly connected to the perforation. The partition has a through-flow channel that connects the actuating chamber and the reservoir chamber. One end of the infusion tube is located in the actuating chamber to connect with the partition and communicate with the flow channel, and the other end extends out of the perforation.

[0007] The advantages of this invention are as follows: Blood can be injected into the storage chamber through the infusion tube and the flow channel, and centrifuged for the first time after the blood separation device is inverted. Then, a collection container is connected to the infusion tube and negative pressure is applied for suction. The blood in the storage chamber flows into the collection container according to Pascal's principle. Suction is stopped when the bottom layer of red blood cells is discharged from the storage chamber. Then, the blood separation device is inverted again and centrifuged for the second time. Finally, the plasma on the top layer after centrifugation and the brownish-yellow layer containing platelets and white blood cells on the bottom layer are extracted in sequence. In this way, it is not necessary to transfer blood to different containers multiple times, and the internal space is always kept sealed, reducing the chance of blood contamination. In addition, the red blood cell layer is discharged from the storage chamber through Pascal's principle, and the blood is not affected by the eddy current stirring effect and can be output in a state where the liquid surface remains flat, avoiding platelets from mixing into the red blood cell layer. At the same time, while the red blood cell layer is being discharged, the separator will also be pushed upward to reduce the size of the storage chamber. Therefore, the part of the container that was originally in contact with the red blood cell layer is no longer located in the storage chamber. This can prevent platelets from coming into contact with residual red blood cells during secondary centrifugation, thereby increasing the concentration of extracted platelets and reducing excessive residual red blood cells.

Implementation Method

[0008] Referring to FIG. 2, one embodiment of the blood separation device 2 of the present invention includes a container 21, a separator 22 movably disposed within the container 21, and an infusion tube 23 connected to the separator 22 and passing through the container 21. The container 21 includes a generally hollow tubular surrounding shell wall 211, a first end wall 212 connected to one end of the surrounding shell wall 211, and a second end wall 213 connected to the other end of the surrounding shell wall 211. A through hole 214 extending horizontally is formed in the surrounding shell wall 211. The through hole 214 is relatively far from the first end wall 212 and relatively adjacent to the second end wall 213. The surrounding shell wall 211 may be marked with graduations along the height direction as needed, but is not limited to this example. The surrounding shell wall 211, the first end wall 212, and the second end wall 213 cooperate to define an internal space 215 communicating with the through hole 214.

[0009] The separator 22 includes a piston 221 surrounded by the surrounding shell wall 211, and a connector 222 connecting the piston 221. The outer peripheral surface of the piston 221 is in sealing contact with the inner surface of the surrounding shell wall 211. Preferably, the outer peripheral surface of the piston 221 is provided with a sealing ring made of rubber or silicone, or the piston 221 may be made entirely of rubber or silicone. The piston 221 divides the internal space 215 into a liquid storage chamber 216 and an actuation chamber 217 communicating with the perforation 214. The piston 221, the surrounding shell wall 211, and the first end wall 212 cooperate to define the liquid storage chamber 216, and the piston 221, the surrounding shell wall 211, and the second end wall 213 cooperate to define the actuation chamber 217. The connector 222 is located in the actuation chamber 217.

[0010] The separator 22 has a through-flow channel 223 that connects the actuation chamber 217 and the reservoir chamber 216. The flow channel 223 has a through hole 224 that passes through the piston 221 and connects to the reservoir chamber 216, and a pinhole 225 that passes through the connector 222 and connects to the through hole 224 and the actuation chamber 217. One end of the infusion tube 23 is fitted into the connector 222 and is located in the actuation chamber 217. The other end of the infusion tube 23 extends through the through hole 214 and extends to the outside, but it is closed and does not directly connect to the outside.

[0011] Before blood is injected, the piston 221 is adjacent to the first end wall 212, and the volume of the liquid storage chamber 216 is almost zero. At this time, the infusion tube 23 is closed, so that the actuation chamber 217 and the liquid storage chamber 216 are sealed, thereby preventing the inner surface of the container 21 from contacting the outside air and avoiding contamination.

[0012] Referring to Figures 2 and 3, the steps of the present invention for extracting high-concentration autologous platelet-rich plasma (PRP) are as follows: The first end wall 212 is placed below, and the second end wall 213 is placed above. Then, blood D is injected into the reservoir chamber 216 through the infusion tube 23 via a syringe (not shown). As the blood input increases, the piston 221 is continuously pushed upward and downward toward the second end wall 213. After the injection of blood D is completed, the syringe is removed, and the embodiment is inverted for the first centrifugation.

[0013] Referring to Figures 2 and 4, after the first centrifugation, the blood D is divided into three layers: a lower red blood cell layer E, an upper plasma layer F, and a middle erythrocyte sedimentation rate (ESR) layer G (buffy coat). A collection container 31 can be connected to the infusion tube 23 and aspirated under negative pressure. The blood D in the reservoir 216 will flow into the collection container 31 through the infusion tube 23 due to Pascal's principle. During the aforementioned process, the piston 221 will move upward and approach the first end wall 212 due to pressure. As a result, the volume of the reservoir 216 will gradually decrease, while the volume of the actuation chamber 217 will gradually increase. After the bottom red blood cell layer E is discharged, the collection container 31 is removed and the infusion tube 23 is resealed, so that the upper plasma layer F and the middle ESR layer G remain in the reservoir 216.

[0014] Referring to Figures 2 and 5, after inverting this embodiment again, the blood separation device 2 is centrifuged a second time to allow the erythrocyte sedimentation rate (ESR) brownish-yellow layer G to settle to the bottom. Finally, a suction container 32 is connected to the infusion tube 23, and the upper plasma layer F is extracted using an extraction method. Then, an extraction container 33 is connected to the infusion tube 23, and the platelet-rich ESR brownish-yellow layer G is extracted using an extraction method. This eliminates the need for multiple transfers of blood D to different containers, and the internal space 215 is not connected to the outside, reducing the chance of blood D becoming contaminated.

[0015] Since the erythrocyte layer E is discharged through Pascal's principle, the piston 221 will push upwards synchronously during the discharge process, reducing the size of the reservoir chamber 216. Therefore, the portion of the shell wall 211 that was originally in contact with the erythrocyte layer E is no longer located in the reservoir chamber 216. This design can prevent the plasma layer F and the erythrocyte sedimentation rate (ESR) brown-yellow layer G from coming into contact with residual erythrocytes during the second centrifugation. In addition, this design can eliminate the eddy current stirring effect, allowing the erythrocyte layer E to be discharged while the stratified liquid surface remains flat, thus avoiding disruption of the stratified liquid surface, which could lead to incomplete removal of the erythrocyte layer E, contaminating the remaining plasma layer F and ESR brown-yellow layer G, thereby increasing the extracted platelet concentration and reducing excessive residual erythrocytes.

[0016] According to the applicant's test, after extraction in this embodiment, the platelet concentration effect can be achieved by an average of 4.5 times, which is similar to the performance of the secondary centrifugation product, but can effectively reduce red blood cell contamination, thereby reducing the discomfort of patients after injection.

[0017] In summary, using the present invention for extraction eliminates the need to change containers and transfer blood D, avoiding contamination of blood D during transfer, increasing safety, and ensuring that the smoothness of the stratified liquid surface is not disrupted during the removal of the red blood cell layer E, preventing platelets from being mixed into the red blood cell layer E and being removed. Furthermore, after the red blood cell layer E is removed, the part that was in contact with the red blood cells is no longer located in the storage chamber 216, so the platelets will not come into contact with the residual red blood cells, ensuring the platelet extraction concentration. Therefore, the purpose of the present invention can indeed be achieved.

[0018] However, the above description is only an embodiment of the present invention and should not be construed as limiting the scope of the present invention. Any simple equivalent changes and modifications made in accordance with the scope of the patent application and the contents of the patent specification shall still fall within the scope of the patent of the present invention. [Simplified Explanation of the Diagram]

[0019] Other features and effects of the present invention will be clearly presented in the embodiments with reference to the drawings, wherein: Figure 1 is a side sectional view illustrating Republic of China Utility Model Patent No. M598150; Figure 2 is a side sectional view illustrating an embodiment of the blood separation device of the present invention; Figure 3 is a schematic diagram illustrating the operation process of injecting blood in this embodiment; Figure 4 is a schematic diagram illustrating the operation process of removing the red blood cell layer after the first centrifugation in this embodiment; and Figure 5 is a schematic diagram illustrating the operation process of extracting platelets after the second centrifugation in this embodiment.

Claims

1. A blood separation device, comprising: a container defining an internal space, the container having a perforation communicating with the internal space, the container including a surrounding shell wall having the perforation radially formed therethrough, a first end wall connected to the surrounding shell wall and relatively away from the perforation, and a second end wall connected to the surrounding shell wall and relatively adjacent to the perforation. A partition, movably disposed in the internal space and in sealed contact with the container, divides the internal space into an actuating chamber directly connected to the perforation and a liquid storage chamber not directly connected to the perforation. The partition has a through-flow channel connecting the actuating chamber and the liquid storage chamber. The partition is surrounded by the surrounding shell wall and in sealed contact with the surrounding shell wall. The end face of the partition facing one end wall of the first end wall is flat, and when the partition abuts against the first end wall, the end face of the partition is parallel and abuts against the first end wall. A delivery tube, one end of which is located in the actuating chamber to connect with the partition and communicate with the flow channel, and the other end extends out of the perforation.

2. The blood separation apparatus as claimed in claim 1, wherein, The separator includes a piston surrounded by the outer shell wall of the container and whose outer peripheral surface is in sealed contact with the outer shell wall, and a connector connected to the piston. The piston, the outer shell wall, and the first end wall cooperate to define the liquid storage chamber, and the piston, the outer shell wall, and the second end wall cooperate to define the actuation chamber.

3. The blood separation apparatus as claimed in claim 2, wherein, The flow channel of the separator has a through hole that passes through the piston and connects to the liquid storage chamber, and a pinhole that passes through the connector and connects the through hole and the actuation chamber.

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