Blood separation device

Abstract

A blood separation device includes a container defining an interior space, a separator movably disposed in the interior space and in sealing contact with the container, and a transfer tube. The separator divides the interior space into an actuation chamber and a storage chamber. The separator defines a flow channel that communicates the actuation chamber and the storage chamber. One end of the transfer tube is in communication with the flow channel, and the other end extends out of the interior space. The device can be centrifuged twice after blood is contained therein, and a platelet-rich buffy coat can be extracted without changing containers. In addition, red blood cells are expelled from the storage chamber by Pascal's principle, and blood can be output without being affected by a vortex stirring effect and can be output in a state in which a liquid surface is flat.

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. Background Technology

[0002] Human blood is mainly composed of plasma and formed elements, which include red blood cells, white blood cells, and platelets. When blood is centrifuged at a certain rate, the formed elements separate into layers in the plasma according to their specific gravity. Red blood cells have the highest specific gravity and therefore settle at the bottom; plasma, containing no cells, has the lowest specific gravity and therefore sits at the top; white blood cells and platelets have a specific gravity between red blood cells and plasma, commonly known as the erythrocyte sedimentation rate (ESR) buffy coat. 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-stage centrifugation, and double-stage centrifugation. Compared to colloid centrifugation and single-stage centrifugation, double-stage centrifugation provides a higher concentration of platelets. Double-stage centrifugation refers to a method that extracts a high concentration of autologous platelet-rich plasma (PRP) by centrifuging blood twice. The 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] See Figure 1The novel centrifuge container 1 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. One end of the connecting tube 12 opens to the bottom of the internal space 111, while 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 separates into three layers that are visually distinguishable: a plasma layer A, a red blood cell layer B, and a brownish-yellow erythrocyte sedimentation rate (ESR) layer C. Then, the sealing cap 14 is removed, and the lower layer of red blood cells B is extracted from the internal space 111 by aspiration. The centrifuge container 1 can then undergo a second centrifugation, and the aforementioned steps are repeated to extract the bottommost layer, the brownish-yellow ESR layer C, rich in platelets, using a syringe.

[0004] However, even when the red blood cell layer B is emptied before the second centrifugation, the eddy current effect causes the blood, which was originally stratified according to specific gravity, to be mixed during the emptying process due to the instability of the water flow and the vortex structure. This prevents the heaviest red blood cells from being expelled separately. As a result, the integrity of the stratification is broken after the liquid level drops, causing some of the lighter white blood cells and platelets to be expelled from 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, some red blood cells remain on the inner wall of the body 11. The erythrocyte sedimentation rate (ESR) brown layer C, containing platelets and white blood cells, comes into contact with the aforementioned area during the second centrifugation process, causing red blood cells to mix into the aforementioned ESR brown layer C containing platelets. This increases the patient's discomfort after injection. Both of these factors affect the extraction concentration and the mixing of red blood cells, and therefore still need to be improved. Summary of the Invention

[0005] The purpose of this invention is to provide a blood separation device that can improve the above-mentioned problems.

[0006] The present invention discloses a blood separation device comprising a container surrounding and defining an internal space, a partition movably disposed within the internal space and in sealed contact with the container, and an infusion tube. The container has a perforation communicating with the internal space. The partition divides the internal space into an actuating chamber directly communicating with the perforation and a storage chamber not directly communicating with the perforation. The partition has a through-flow channel communicating with the actuating chamber and the storage 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 blood separation device of the present invention includes a container comprising a surrounding shell wall that surrounds and is in sealing contact with the separator, a first end wall that connects to the surrounding shell wall and is relatively far away from the perforation, and a second end wall that connects to the surrounding shell wall and is relatively adjacent to the perforation.

[0008] The blood separation device of the present invention includes a separator comprising a piston surrounded by the outer shell wall of the container and having its outer peripheral surface 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.

[0009] The blood separation device of the present invention has a flow channel of the separator having a through hole that passes through the piston and communicates with the liquid storage chamber, and a pinhole that passes through the connector and communicates with the through hole and the actuation chamber.

[0010] The beneficial effects of this invention are as follows: Blood can be injected into the storage chamber through the infusion tube and the flow channel, and undergo a first centrifugation after the blood separation device is inverted. Then, the collection container is connected to the infusion tube and negative pressure is applied for suction. Due to Pascal's principle, the blood in the storage chamber flows into the collection container. Suction stops when the bottom layer of red blood cells is discharged from the storage chamber. The blood separation device is then inverted again for a second centrifugation. Finally, the plasma layer on top and the lower layer containing platelets and white blood cells (the brownish-yellow erythrocyte sedimentation rate layer) are sequentially extracted. This eliminates the need for multiple transfers of blood to different containers, and the internal space remains sealed, reducing the chance of blood contamination. Furthermore, the red blood cell layer is discharged from the storage chamber through Pascal's principle; the separator moves upwards to discharge the red blood cells, preventing the blood from being affected by eddy currents and allowing it to be output while maintaining a flat liquid surface, thus avoiding platelets mixing into the red blood cell layer. Simultaneously, as the red blood cell layer is discharged, the separator is 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 avoids the platelets coming into contact with residual red blood cells during secondary centrifugation, thereby increasing the extracted platelet concentration and reducing excessive residual red blood cells. Attached Figure Description

[0011] Figure 1 This is a side sectional view illustrating a traditional centrifuge container;

[0012] Figure 2 This is a side sectional view illustrating an embodiment of the blood separation device of the present invention;

[0013] Figure 3 This is a schematic diagram illustrating the operation process of injecting blood in the described embodiment;

[0014] Figure 4 This is a schematic diagram illustrating the process of removing the red blood cell layer after the first centrifugation in the described embodiment;

[0015] Figure 5 This is a schematic diagram illustrating the platelet extraction process after the second centrifugation in the described embodiment. Detailed Implementation

[0016] See Figure 2 An 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 horizontally penetrating perforation 214 is formed in the surrounding shell wall 211. The perforation 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 its height as needed, but this is not a limitation of the 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 perforation 214.

[0017] 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 entirely made 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 within the actuation chamber 217.

[0018] The separator 22 has a through-flow channel 223 that connects the actuation chamber 217 and the reservoir chamber 216. The 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 the through-hole 224 and the actuation chamber 217. One end of the infusion tube 23 is fitted into the connector 222 and located in the actuation chamber 217. The other end of the infusion tube 23 extends through the perforation 214 to the outside, but is sealed and not directly connected to the outside.

[0019] 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, making the actuation chamber 217 and the liquid storage chamber 216 sealed, so that the inner surface of the container 21 will not come into contact with the outside air and avoid contamination.

[0020] See Figure 2 and Figure 3 The present invention is applied to the extraction of high-concentration autologous platelet-rich plasma (PRP) using the following steps: The first end wall 212 is positioned below, with the second end wall 213 positioned above. Blood D is then injected into the reservoir chamber 216 via the infusion tube 23 using a syringe (not shown). As the blood input increases, the piston 221 is continuously pushed upwards towards the second end wall 213. After the injection of blood D is complete, the syringe is removed, and the embodiment is inverted for the first centrifugation.

[0021] See Figure 2 and Figure 4 After the first centrifugation, the blood D separates 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. Due to Pascal's principle, the blood D in the reservoir 216 flows into the collection container 31 through the infusion tube 23. During this process, the piston 221 moves upwards and closer to the first end wall 212 due to pressure. As a result, the volume of the reservoir 216 gradually decreases, while the volume of the actuation chamber 217 gradually increases. After the bottom red blood cell layer E is discharged, the collection container 31 is removed and the infusion tube 23 is resealed, leaving the upper plasma layer F and the middle ESR layer G in the reservoir 216.

[0022] See Figure 2 and Figure 5After inverting the device again, the blood separation apparatus 2 is centrifuged a second time, causing the erythrocyte sedimentation rate (ESR) brownish-yellow layer G to settle to the bottom. Finally, an extraction container 32 is connected to the infusion tube 23, and the upper plasma layer F is extracted. Then, an extraction container 33 is connected to the infusion tube 23, and the platelet-rich ESR brownish-yellow layer G is extracted. 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.

[0023] Since the erythrocyte layer E is discharged via Pascal's principle, the piston 221 will simultaneously rise 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 prevents the plasma layer F and the erythrocyte sedimentation rate (ESR) brown-yellow layer G from contacting residual erythrocytes during secondary centrifugation. Furthermore, this design eliminates the eddy current effect, allowing the erythrocyte layer E to be discharged while maintaining a flat liquid surface. This prevents disruption of the 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. This, in turn, increases the extracted platelet concentration and reduces excessive residual erythrocytes.

[0024] According to the applicant's tests, the platelet concentration effect after extraction in this embodiment can reach 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 patient discomfort after injection.

[0025] In summary, using this invention for extraction eliminates the need for container changes and blood D transfer, preventing contamination of blood D during transfer and increasing safety. It also ensures 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 and removed from the red blood cell layer E. Furthermore, after the red blood cell layer E is removed, the area in contact with the red blood cells is no longer located in the storage chamber 216, thus preventing platelets from contacting residual red blood cells and ensuring the platelet extraction concentration. Therefore, the purpose of this invention is indeed achieved.

[0026] The above description is merely 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 claims and description of the present invention shall still fall within the scope of the present invention.

Claims

1. A blood separation device, characterized in that: The blood separation device includes a container defining an internal space, a partition movably disposed in the internal space and in sealed contact with the container, and an infusion tube. The container has a perforation communicating with the internal space. The partition divides the internal space into an actuating chamber directly communicating with the perforation and a reservoir chamber not directly communicating with the perforation. The partition has a through-flow channel communicating with 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.

2. The blood separation device according to claim 1, characterized in that: The container includes a surrounding shell wall that surrounds and is in sealing contact with the partition, a first end wall that connects to the surrounding shell wall and is relatively far from the perforation, and a second end wall that connects to the surrounding shell wall and is relatively adjacent to the perforation.

3. The blood separation device according to claim 2, characterized in that: The separator includes a piston surrounded by the outer shell wall of the container and having its outer peripheral surface 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.

4. The blood separation device according to claim 3, characterized in that: 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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