An optimized device for freely switching between blood cell component removal and plasma exchange

Abstract

The present invention discloses a device for freely switching and optimizing blood cell component removal and plasma exchange, which is used to solve the problems of poor treatment effect, high use of consumables, long time consumption and high cost, and narrow clinical application scope of the equipment in the prior art. This application removes the flow rate control of the plasma collection pump by adding an additional hanging hook, modifying the plasma exchange output pipeline to separate the plasma collection pump from the plasma collection pump and installing it on the upper part of the panel, and adding a liquid level sensor; marking the volume scale on the waste liquid collection bag, and then adjusting the patient's HCT data and liquid compensation, it can use the same consumable pipeline on the Spectra Optia blood component separator to make red blood cell removal or replacement, lymphocyte removal and plasma exchange and other treatment operations can be freely selected and switched or performed simultaneously, so as to meet the clinical treatment purpose to the greatest extent, improve the treatment effect, optimize the treatment process, and reduce the treatment cost. Thereby, not only the clinical application scope of the instrument pipeline is greatly increased, but also the treatment needs can be freely switched and selected.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and particularly to an optimized device for freely switching between blood cell component removal and plasma exchange. Background Art

[0002] In recent years, the incidence of difficult, complex and critical diseases has been increasing year by year. The conventional treatment of such diseases has poor effects, poor prognosis and high fatality rate, seriously threatening the lives and health of the people in our country. The pathogenesis of such diseases often involves immune disorders and imbalances in the body. It is necessary to remove immune active cells such as lymphocytes and activated macrophages and related pathogenic antibodies to reconstruct the immune balance of the body in order to achieve stable curative effects. At present, clinically, the treatment of removing immune active cells and plasma exchange and other treatments are becoming more and more prominent in the treatment of difficult, complex and critical patients. The treatment method of combining the two treatment methods of removing immune active cells such as lymphocytes and plasma exchange is called lymphoplasmapheresis. The technique of combining multiple treatment techniques such as plasma exchange, red blood cell exchange, and leukocyte removal is called total blood exchange. Total blood exchange not only removes the end products of metabolism such as destructive antibodies, antigen-antibody complexes, inflammatory mediators, and hemoglobin by-products (free iron, methemoglobin) in the patient's plasma, but also removes the immune active cells that produce antibodies in the patient's body and the red blood cells sensitized by antibodies, reducing the further damage of hemolytic factors to the body tissues and organs. At the same time, the red blood cells transfused into the patient's body are more likely to survive in the patient's body, thus quickly alleviating the progress of the patient's hemolysis and providing a better platform for clinical treatment. Total blood exchange is widely used in the treatment of various hemolytic diseases, such as autoimmune hemolytic anemia, mismatched blood transfusion, drug-induced hemolysis, and passenger lymphocyte syndrome. The method of combining total blood exchange and lymphoplasmapheresis and flexibly applying it according to the clinical needs of the disease is called semi-total blood exchange. We collectively refer to these techniques as therapeutic blood component removal and plasma exchange.

[0003] The application of the above techniques is becoming more and more powerful in the treatment of difficult, complex and critical patients. Previously, the earliest traditional treatment methods, such as red blood cell removal, lymphocyte removal, and plasma exchange, could only be carried out separately. Multiple sets of consumables needed to be prepared, and different programs needed to be selected on the same machine in sequence to meet the clinical needs.

[0004] Firstly, the separate treatment is not exact in curative effect. Secondly, changing the consumables wastes a lot of time, is not conducive to clinical operation and increases the economic burden of the patient, and the price is very expensive.

[0005] In recent years, many experts and scholars have continuously tried and improved, aiming to develop a therapeutic blood component removal and plasma exchange operation mode that can achieve multiple treatments in the same set of pipelines. For example, Terumo COBE Spectra, Fresenius KABI, etc. have achieved multiple program operations in a set of pipelines through relevant improvements, greatly meeting the clinical treatment needs. However, with the replacement of instruments and the redesign of pipelines, the new generation of Terumo Spectra Optia cancels manual operation modes during instrument design, and the pipeline design is also more conservative and strict. The flexibility of plasma exchange and cell component removal regulation becomes worse, making the free adjustment and switching operations that could originally be achieved on older-generation instruments unable to meet the clinical treatment needs due to instrument program design and pipeline limitations. It is necessary to return to the traditional method of using multiple sets of pipelines for individual procedures separately, which not only increases the treatment cost but also takes more time, and the curative effect is greatly reduced.

[0006] Therefore, it is particularly important to realize an optimized device for free switching between blood cell component removal and plasma exchange by adjusting the operation procedure of the new Spectra Optia instrument and modifying the pipeline, which is ultimately beneficial to clinical treatment. Summary of the Invention

[0007] The purpose of the present invention is to provide an optimized device for free switching between blood cell component removal and plasma exchange, which solves the problems in the prior art that the separate treatments of red blood cell removal and replacement, lymphocyte removal, and plasma exchange have poor treatment effects, consume a lot of consumables, take a long time, are expensive, and have a narrow clinical application range of the equipment.

[0008] To solve the above technical problems, the present invention adopts the following technical solutions:

[0009] The present invention provides an optimized device for free switching between blood cell component removal and plasma exchange, including a blood component separator, an external replacement fluid passage, a waste liquid collection bag, a centrifugal separation belt, a pipeline clamping plate, a saline pipeline, an anticoagulant pipeline, a blood collection pipeline, a blood transfusion pipeline, an anticoagulant pump, a blood collection pump, a plasma collection pump, a replacement fluid pump, and a blood transfusion pump;

[0010] Wherein the blood separator includes a blood cell transfusion passage and a plasma exchange output passage;

[0011] Wherein a blood collection pipeline sieve tube and a blood collection pressure sensor are provided on the blood collection pipeline, and the blood collection pipeline sieve tube and the blood collection pressure sensor are limited and arranged on the pipeline clamping plate;

[0012] A blood storage device and a blood transfusion pressure sensor are provided on the blood transfusion pipeline. A high liquid level sensor and a low liquid level sensor for detecting the liquid level are provided in the blood storage device; A blood storage device filter is also provided at the bottom of the blood storage device;

[0013] A blood cell valve for adjusting the red blood cell delivery tube is provided on the pipeline clamping plate; a red blood cell detector is also provided on the pipeline clamping plate.

[0014] Further, the upper end of the externally connected replacement fluid passage is connected to a replacement fluid bag, and the replacement fluid bag is pre-filled with the donor's plasma, red blood cells or other replacement fluid components;

[0015] Wherein the replacement fluid pump is used to transfer the donor's plasma, red blood cells or other replacement fluid components in the replacement fluid bag through the externally connected replacement fluid passage to the blood storage device, and is used to be transfused into the patient's body together with the cell components in the blood cell transfusion passage.

[0016] Still further, a collection bag scale is provided on the waste liquid collection bag, and a liquid level sensor is provided at the bottom of the waste liquid collection bag;

[0017] The plasma exchange output passage operates the components to be removed to the waste liquid collection bag through a plasma collection pump, and the waste liquid collection bag is hung on the hanging hook above the blood component separator.

[0018] Still further, a pipeline hanging hook is provided on the pipeline clamping plate, and a plasma exchange output passage is hung on the pipeline hanging hook.

[0019] Still further, the blood component separator is connected with a blood collection pipeline, a blood separation pipeline and a transfusion pipeline through pipelines;

[0020] One end of the blood collection pipeline is used for blood collection; the blood separation pipeline is connected to the blood cell transfusion passage and the plasma exchange output passage, and the plasma exchange output passage is communicated with the waste liquid collection bag; the transfusion pipeline is connected to the blood cell transfusion passage and the externally connected replacement fluid passage, and is connected to the patient's vein through the blood component separator's transfusion end.

[0021] Still further, the plasma collection pump transports the components to be removed into the waste liquid bag;

[0022] The replacement fluid pump transfers the donor's plasma, red blood cells or other replacement fluid components in the replacement fluid bag to the blood storage device;

[0023] The blood collection pipeline and the blood component separator are connected with an anticoagulant pipeline, and the upper end of the anticoagulant pipeline is communicated with an anticoagulant bag; wherein the anticoagulant pipeline transports the anticoagulant therein to the blood collection pipeline through an anticoagulant pump to realize mixing with the blood.

[0024] Still further, the transfusion pipeline is connected to the blood cell transfusion passage and the externally connected replacement fluid passage through a blood storage device;

[0025] A freely movable cartridge (an additionally added manual control hemostatic clamp) is provided on the blood cell reinfusion path for clamping the blood cell reinfusion path.

[0026] The freely movable cartridge is an additionally added manual control hemostatic clamp, and the blood cell reinfusion path is clamped by the manual control hemostatic clamp.

[0027] Furthermore, a plasma valve for adjusting the plasma exchange output path is provided on the pipeline clamping plate; a removal valve for adjusting the opening and closing of the external replacement substitution fluid path is also provided on the pipeline clamping plate.

[0028] Compared with the prior art, the beneficial technical effects of the present invention are as follows:

[0029] The blood cell component removal and plasma exchange free switching and optimization device provided by the present application improves the free clamping of the blood cell reinfusion pipeline and the pipeline installation on the basis of plasma exchange, and releases the flow rate control of the plasma collection pump by additionally adding a hanging hook and a liquid level sensor;

[0030] Volume scales are marked on the waste liquid collection bag, and through the adjustment of the patient's HCT data and liquid compensation, treatment operations such as red blood cell removal or replacement, lymphocyte removal, and plasma exchange can be freely selected and switched or carried out simultaneously on the Spectra Optia blood component separator with the same consumable pipeline, which can meet the clinical treatment purposes to a greater extent, improve the treatment effect, optimize the treatment process, and reduce the treatment cost.

[0031] Thus, not only the clinical application range of the instrument pipeline is greatly increased, but also the treatment requirements can be freely switched and selected. BRIEF DESCRIPTION OF THE DRAWINGS

[0032] The present invention will be further described below in conjunction with the drawings.

[0033] Figure 1 It is a system flow schematic diagram of the blood cell component removal and plasma exchange free switching and optimization device provided by the present application;

[0034] Figure 2 It is an operation structure schematic diagram of the blood cell component removal and plasma exchange free switching and optimization device provided by the present application;

[0035] Figure 3 It is a three-dimensional view of the blood cell component removal and plasma exchange free switching and optimization device provided by the present application;

[0036] Figure 4 It is a pipeline component structure schematic diagram of the blood cell component removal and plasma exchange free switching and optimization device provided by the present application;

[0037] Figure 5 For Figure 4 Enlarged view of part A in

[0038] Explanation of reference numerals in the drawings: 1. External replacement solution passage; 2. Waste liquid collection bag; 21. Plasma exchange output passage; 22. Scale of the collection bag; 23. Liquid level sensor; 3. Centrifugal separation belt; 4. Pipeline clamping plate; 401. Blood collection pipe sieve; 402. Blood collection pressure sensor; 403. Blood storage filter; 404. Blood transfusion pressure sensor; 405. High liquid level sensor; 406. Low liquid level sensor; 407. Blood cell valve; 408. Plasma valve; 409. Removal valve; 410. Red blood cell detector; 411. Centrifugal pressure sensor; 5. Salt water pipeline; 6. Anticoagulant pipeline; 7. Blood collection pipeline; 8. Blood transfusion pipeline; 9. Anticoagulant pump; 10. Blood collection pump; 11. Plasma collection pump; 12. Replacement solution pump; 13. Blood transfusion pump; 14. Pipeline hook. Specific embodiments

[0039] In this embodiment, an optimized device for freely switching between blood cell component removal and plasma exchange is disclosed, which includes a blood component separator, an external replacement solution passage 1, a waste liquid collection bag 2, a centrifugal separation belt 3, a pipeline clamping plate 4, a salt water pipeline 5, an anticoagulant pipeline 6, a blood collection pipeline 7, a blood transfusion pipeline 8, an anticoagulant pump 9, a blood collection pump 10, a plasma collection pump 11, a replacement solution pump 12, and a blood transfusion pump 13.

[0040] Among them, the blood component separator needs to be equipped with a disposable blood cell separator (model 10226 pipeline), and the blood component separator is connected with a blood collection pipeline 7, a blood separation passage, and a blood transfusion pipeline 8 through pipelines;

[0041] In this embodiment, the blood component separator is a Spectra Optia blood separator; the blood collection pipeline 7 is connected to the median cubital vein, radial artery or dorsal artery of the foot of the patient for blood collection; the blood separation passage is connected to the blood cell transfusion passage and the plasma exchange output passage 21, and the plasma exchange output passage 21 is communicated with a waste liquid collection bag 2; the blood transfusion pipeline 8 is connected to the blood cell transfusion passage and the external replacement solution passage 1, and is connected to the patient's vein through the blood transfusion end of the blood component separator.

[0042] In the above implementation process, the blood collection pump 10 transports the blood in the patient's body through the blood collection pipeline 7 to the Spectra Optia blood component separator through a collection blood vessel such as the median cubital vein, radial artery or dorsal pedal artery. The Spectra Optia blood component separator separates the collected patient blood into cellular components and plasma components in the blood by centrifugation. The cellular components include formed elements such as red blood cells, white blood cells and platelets; the white blood cells include immunocompetent cells such as neutrophils and lymphocytes;

[0043] Among them, the separated blood components are respectively transported to the blood cell reinfusion pathway and the plasma exchange output pathway through the blood separation pathway of the blood component separator; the plasma collection pump 11 transports the components to be removed to the waste liquid bag 2.

[0044] The replacement fluid pump 12 transports the donor's plasma, red blood cells or other replacement fluid components in the replacement fluid bag to the blood storage device, so as to be reinfused into the patient's body together with the cellular components in the blood cell reinfusion pathway. Each pipeline is connected through the instrument.

[0045] In a specific implementation, the blood collection pipeline 7 and the Spectra Optia blood component separator are connected with an anticoagulant pipeline 6. The upper end of the anticoagulant pipeline 6 is connected with an anticoagulant bag, and the anticoagulant bag is suspended above the Spectra Optia blood component separator; among them, the anticoagulant pipeline 6 transports the anticoagulant in it to the blood collection pipeline 7 through the anticoagulant pump 9 to achieve mixing with the blood, and is used to prevent blood coagulation; among them, the collected blood and the anticoagulant are mixed and then enter the blood separation zone 3 through the blood collection pump 10 through the collection pathway for separation.

[0046] In the above implementation, the collected blood enters the blood separation pathway after being separated by the blood separation zone 3, and the blood separation pathway is respectively connected to the blood cell reinfusion pathway and the plasma exchange output pathway.

[0047] In the above specific implementation, the plasma exchange output pathway in the Spectra Optia blood component separator transports the components to be removed (plasma, immunocompetent cells such as neutrophils and lymphocytes, and components other than red blood cells) to the waste liquid collection bag 2 through the plasma collection pump 11. The waste liquid collection bag 2 is installed on the hanging hook above the Spectra Optia blood component separator.

[0048] In a specific implementation, the patient's venous reinfusion is connected with a reinfusion pipeline 8. The reinfusion pipeline 8 is connected with a blood cell reinfusion pathway (mainly transporting red blood cells) and an external replacement fluid pathway 1 through a blood storage device.

[0049] In this implementation process, a free - moving cartridge (specifically, an additional manually - controlled hemostatic clamp) needs to be added to the blood cell reinfusion pathway at the upper end of the blood storage device to clamp the pathway. By opening or closing the pathway, it controls whether the components in the blood cell reinfusion pathway enter the blood storage device, thereby controlling their entry into the patient's body.

[0050] In the above - mentioned implementation, after the blood cell reinfusion pathway is clamped by the free - moving cartridge (the additional manually - controlled hemostatic clamp), due to the flow rate control and limitation of the plasma collection pump 11 in the blood separation pathway, the blood cell components cannot be pumped out, so a large amount of cell components are retained in the blood separation belt 3, triggering a centrifugal pressure alarm.

[0051] In the above - mentioned specific implementation, first, deactivate the red blood cell detector 410 on the plasma exchange output pathway, disconnect the plasma exchange output pathway 21 from the plasma collection pump 11, and manually lift the flow rate limitation of the automatically - recognized plasma collection to prevent the centrifugal pressure alarm induced by the retention of a large amount of cells. At the same time, add a hanging hook above the installation panel to flexibly fix the plasma exchange output pathway at the plasma collection pump 11 to prevent the plasma exchange pathway here from rotating into the plasma collection pump 11. In addition, install an external liquid - level sensor 23 on the plasma exchange output pathway 21 to sense the normal flow of the liquid.

[0052] The present invention proposes to install a 10226 pipeline on the new - generation Terumo Spectra Optia instrument. First, clamp the red blood cell reinfusion tube through a free - moving cartridge (an additional manually - controlled hemostatic clamp) to close the patient's own red blood cell reinfusion pathway.

[0053] Secondly, transform the plasma exchange output pipeline to disconnect it from the plasma collection pump 11 and install it on the pipeline hanging hook 14 added above the panel, lift the flow rate limitation of the plasma collection pump 11 for blood component removal, and at the same time install an external liquid - level sensor 23 on the plasma exchange output pipeline.

[0054] Thirdly, achieve liquid balance by adjusting the patient's HCT data and the liquid compensation mode. Finally, mark the collection - bag scale 22 for collecting the volume on the waste - liquid collection bag 2 for blood components to observe whether the liquid input - output data is balanced.

[0055] Thus, the new Spectra Optia instrument can achieve the optimized mode of freely switching between blood cell component removal and plasma exchange, achieving the clinical treatment purpose that treatment operations such as red blood cell removal or replacement, lymphocyte removal, and plasma exchange can be freely selected, switched, or carried out simultaneously, thereby improving the treatment effect, optimizing the treatment process, and reducing the treatment cost.

[0056] The above embodiments are only descriptions of the preferred embodiments of the present invention, and do not limit the scope of the present invention. Without departing from the spirit of the present invention, various deformations and improvements made by those of ordinary skill in the art to the technical solutions of the present invention shall fall within the protection scope determined by the claims of the present invention.

Claims

1. A blood cell component removal and plasma exchange free switching optimization device, comprising a blood component separator, an external replacement fluid passage (1), a waste fluid collection bag (2), a centrifugal separation belt (3), a pipeline clamp (4), a saline pipeline (5), an anticoagulant pipeline (6), a blood collection blood pipeline (7), a return pipeline (8), an anticoagulant blood pump (9), a blood collection pump (10), a plasma collection pump (11), a replacement fluid pump (12), and a blood return pump (13); The blood component separator comprises a blood cell return passage and a plasma exchange output passage (21); Features: A blood collection tube screen (401) and a blood collection pressure sensor (402) are provided on the blood collection tube circuit (7); the blood collection tube screen (401) and the blood collection pressure sensor (402) are limitedly arranged on the circuit clamp (4); A blood reservoir and a return pressure sensor (404) are provided on the return pipe (8), wherein a high liquid level sensor (405) and a low liquid level sensor (406) for detecting liquid level are provided in the blood reservoir; a blood reservoir filter (403) is also provided at the bottom of the blood reservoir; A blood cell valve (407) for regulating the red blood cell transport tube is arranged on the pipeline card plate (4); a red blood cell detector (410) is also arranged on the pipeline card plate (4); A collection bag scale (22) is provided on the waste liquid collection bag (2), and a liquid level sensor (23) is provided at the bottom of the waste liquid collection bag (2); A pipeline hook (14) is provided on the pipeline clamping plate (4); A freely movable cassette is provided on the blood cell reinfusion passage for clamping the blood cell reinfusion passage; During implementation, the red blood cell detector (410) on the plasma exchange output passage (21) is first deactivated, the plasma exchange output passage (21) is separated from the plasma collection pump (11), and the flow rate limit of the automatic identification of plasma collection is manually released, thereby preventing the centrifugal pressure alarm induced by the retention of a large number of cells; at the same time, a hanging hook is added above the installation panel to flexibly fix the plasma exchange output passage (21) at the plasma collection pump (11) to prevent the plasma exchange passage here from rotating into the plasma collection pump (11); in addition, an external liquid level sensor (23) is installed on the plasma exchange output passage (21) to sense the normal flow of the liquid.

2. The optimized device for freely switching between blood cell component removal and plasma exchange according to claim 1, wherein: The upper end of the external replacement fluid passage (1) is connected to a replacement fluid bag, in which the donor's plasma, red blood cells or other replacement fluid components are pre-filled; The replacement fluid pump (12) is used to move the donor's plasma, red blood cells or other replacement fluid components in the replacement fluid bag through the external replacement fluid passage (1) to the blood reservoir, and is used to be reinfused into the patient together with the cell components in the blood cell reinfusion passage.

3. The blood cell component removal and plasma exchange free switching optimization device according to claim 1, characterized in that: The plasma exchange output path (21) transports the components to be removed through the plasma collection pump (11) to the waste liquid collection bag (2), and the waste liquid collection bag (2) is arranged on the hanging hook above the blood component separator.

4. The optimized device for freely switching between blood cell component removal and plasma exchange according to claim 1, wherein: Among them, the plasma exchange output path is hung on the pipeline hanging hook (14).

5. The optimized device for freely switching between blood cell component removal and plasma exchange according to claim 1, wherein: The blood component separator is connected with a blood collection pipeline (7), a blood separation path, and a blood transfusion pipeline (8) through pipelines; Among them, one end of the blood collection pipeline (7) is used for blood collection; the blood separation path is connected with a blood cell transfusion path and a plasma exchange output path (21), and the plasma exchange output path (21) is communicated with the waste liquid collection bag (2); the blood transfusion pipeline (8) is connected with a blood cell transfusion path and an external replacement fluid path (1), and is connected to the patient's vein through the blood transfusion end of the blood component separator.

6. The optimized device for freely switching between blood cell component removal and plasma exchange according to claim 5, characterized in that: The plasma collection pump (11) transports the components to be removed into the waste liquid collection bag (2); The replacement fluid pump (12) transports the donor's plasma, red blood cells or other replacement fluid components in the replacement fluid bag to the blood storage device; The blood collection pipeline (7) and the blood component separator are connected with an anticoagulant pipeline (6), and the upper end of the anticoagulant pipeline (6) is communicated with an anticoagulant bag; among them, the anticoagulant pipeline (6) transports the anticoagulant in it to the blood collection pipeline (7) through the anticoagulant pump (9) to achieve mixing with the blood.

7. The optimized device for freely switching between blood cell component removal and plasma exchange according to claim 1, characterized in that: The blood transfusion pipeline (8) is connected with a blood cell transfusion path and an external replacement fluid path (1) through a blood storage device; The freely movable cartridge is an additionally added manual control hemostatic clamp, and the blood cell transfusion path is clamped by the manual control hemostatic clamp.

8. The optimized device for freely switching between blood cell component removal and plasma exchange according to claim 1, wherein: A plasma valve (408) for adjusting the plasma exchange output path (21) is arranged on the pipeline clamping plate (4); a removal valve (409) for adjusting the opening and closing of the external replacement fluid path (1) is also arranged on the pipeline clamping plate (4).

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