INFUSION PUMP AND INFUSION METHOD DEDICATED FOR STEM CELL
20190175830 ยท 2019-06-13
Inventors
- Yulin Cao (Beijing, CN)
- Juntang Lin (Beijing, CN)
- Xiayun Li (Beijing, CN)
- Wei He (Beijing, CN)
- Shihong Liu (Beijing, CN)
- Chengqian Lu (Beijing, CN)
Cpc classification
A61L33/068
HUMAN NECESSITIES
A61K35/00
HUMAN NECESSITIES
A61M5/158
HUMAN NECESSITIES
A61M5/152
HUMAN NECESSITIES
A61M5/16813
HUMAN NECESSITIES
A61L33/064
HUMAN NECESSITIES
A61L31/028
HUMAN NECESSITIES
A61L33/04
HUMAN NECESSITIES
A61K35/28
HUMAN NECESSITIES
International classification
A61M5/168
HUMAN NECESSITIES
A61M5/158
HUMAN NECESSITIES
A61M16/08
HUMAN NECESSITIES
A61L33/04
HUMAN NECESSITIES
Abstract
The special infusion pump for stem cells includes a liquor storage device and an infusion pipe. The inner wall of the liquor storage sac and the infusion pipe is provided with a layer of anionic protective film, to prevent stem cells in physic liquor from adhering to the inner wall of the liquor storage sac and the infusion pipe using mutual repulsion between anions. The infusion method includes: checking an infusion pump for integrity; closing a liquor stop clamp, injecting a mixed liquor of stem cells and medicine; covering a protective cap, opening the liquor stop clamp, closing the liquor stop clamp for use; connecting an external cone joint with a venous cannula, and then opening the liquor stop clamp; steadily placing the liquor storage sac on a horizontal plane using an auxiliary placing device; and after infusion ends, closing the liquor stop clamp, and disconnecting the external cone joint.
Claims
1. An infusion pump for stem cells, comprising: a liquor storage device and an infusion pipe, wherein said liquor storage device is comprised of a protective housing in which a cavity structure is formed and a liquor storage sac disposed in the protective housing, wherein the bottom of the protective housing is provided with a through hole, the infusion pipe is connected with the liquor storage sac through the through hole, the infusion pipe is provided with a medicine infusion port, a liquor stop clamp, a flow control device and an external cone joint in sequence from the end close to the liquor storage device to the end far away from the liquor storage device; and the inner wall of the liquor storage sac and the infusion pipe is provided with a layer of anionic protective film.
2. The special infusion pump for stem cells according to claim 1, wherein said liquor storage sac is comprised of silicon rubber.
3. The special infusion pump for stem cells according to claim 1, wherein a size of the cavity structure in the protective housing is greater than the minimum deformation size of the liquor storage sac and is less than the maximum deformation size of the liquor storage sac.
4. The special infusion pump for stem cells according to claim 1, wherein a medicine infusion port is externally provided with a one-way check valve, and wherein the one-way check valve is provided with a protective cap.
5. The special infusion pump for stem cells according to claim 1, wherein the protective housing is comprised of an auxiliary placing device.
6. The special infusion pump for stem cells according to claim 1, wherein the anionic protective film comprises a substrate as an anticoagulation layer stacked on one side surface of the substrate.
7. The special infusion pump for stem cells according to claim 1, wherein the substrate is prepared from components of the following part by weight: 20-30 parts by weight of polyvinyl resin, 6-12 parts by weight of tourmaline powder, 0.5-0.7 part by weight of methylcellulose and 0.3-0.6 part by weight of polymethacrylic acid; and wherein the anticoagulation layer is prepared from components of the following part by weight: 7.5-10 parts by weight of cholesteryl palmitate, 3.5-5 parts by weight of sodium oleate, 1-3 parts by weight of sodium stearyl lactate, and 0.2-0.5 part by weight of sodium stearate.
8. The special infusion pump for stem cells according to claim 1, wherein the protective housing, the one-way check valve, the liquor stop clamp, the flow control device and the external cone joint are comprised of medical-level PP plastics, and wherein the infusion pipe is comprised of medical-level PVC plastics.
9. The special infusion pump for stem cells according to claim 1, further comprising: a medicine inhalation device matching with same.
10. An infusion method for stem cells, the method comprising the following steps: Step 1. carefully checking each working component of an infusion pump for integrity; Step 2. closing a liquor stop clamp, taking off a protective cap, and injecting a pre-prepared mixed liquor of stem cells and medicine into the liquor storage sac by an injector through the medicine infusion port; Step 3. covering the protective cap, opening the liquor stop clamp, until no bubble exists in the infusion pump, closing the liquor stop clamp for use; Step 4. connecting an external cone joint with a venous cannula in the body of a patient to be infused, and then opening the liquor stop clamp, to guarantee that the mixed liquor of the stem cells and the medicine is infused into the body of the patient using the uniform elastic recoil of the liquor storage sac in cooperation with the action of the flow control device; Step 5. steadily placing the liquor storage sac on a horizontal plane or hanging same in a certain position using an auxiliary placing device disposed on the protective housing; Step 6. after infusion ends, closing the liquor stop clamp first, and then disconnecting the external cone joint from the venous cannula in the body of the patient; and Step 7. inhaling the remaining physic liquor from the external cone joint by a medicine inhalation device.
Description
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS
[0031]
[0032]
[0033]
[0034] Reference numeral: 1. protective housing; 2. liquor storage sac; 21. anionic protective film; 3. protective cap; 4. one-way check valve; 5. liquor stop clamp; 6. external cone joint; 7. flow control device; 8. auxiliary placing device.
DETAILED DESCRIPTION OF THE INVENTION
[0035] In order to explain in detail the technical contents, structural features, objects and effects of the present invention, the present invention is described below in detail with reference to embodiments and the drawings.
Embodiment 1
[0036] Referring to
[0037] The medicine infusion port is externally provided with a one-way check valve 4, so that physic liquor can only be injected into the infusion pump through the medicine infusion port but cannot flow out from the medicine infusion port, moreover, the one-way check valve 4 is provided with a protective cap 3 used to prevent physic liquor from being polluted; the protective housing 1 is provided with an auxiliary placing device 8, the auxiliary placing device 8 being a hook or support leg arranged on the housing and being used to steadily place or hang the protective housing 1 together with the liquor storage sac 2 in a certain position, to guarantee the stability of the pump during operation. The infusion pipe is made of medical-level PVC plastics, so that the pipe material may not react with the physic liquor, is safe and sanitary, and is transparent, thereby facilitating clinical observation of medical staff; the protective housing 1, the one-way check valve 4, the liquor stop clamp 5, the flow control device 7 and the external cone joint 6 are made of medical-level PP plastics, thereby guaranteeing certain strength thereof while guaranteeing the safety and sanitation thereof, and guaranteeing the normal operation of the infusion pump.
[0038] As shown in
Embodiment 2
[0039] A special infusion pump for stem cells, the infusion pump is different from embodiment 1 in that the anionic protective film includes a substrate prepared from components of the following part by weight: 20 parts by weight of polyvinyl resin, 6 parts by weight of tourmaline powder, 0.5 part by weight of methylcellulose and 0.3 part by weight of polymethacrylic acid. The anionic protective film is extruded into a polyethylene self-adhesive film together with micro-adhesive EVA. Because the film is mixed with tourmaline powder in the making process, the protective film can release anions. Because the basic structure of the cell membrane is a bilayer composed of phospholipids, and the phosphorus-containing portion of the phospholipid molecules carries negative charge, stem cells in the physic liquor are prevented from adhering to the inner wall of the liquor storage sac 2 and the pipe using the effect like charges repel each other.
Embodiment 3
[0040] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 25 parts by weight of polyvinyl resin, 8 parts by weight of tourmaline powder, 0.6 part by weight of methylcellulose and 0.4 part by weight of polymethacrylic acid.
Embodiment 4
[0041] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 30 parts by weight of polyvinyl resin, 12 parts by weight of tourmaline powder, 0.7 part by weight of methylcellulose and 0.6 part by weight of polymethacrylic acid.
Embodiment 5
[0042] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that an anticoagulation layer is stacked on one side surface of the substrate, the anticoagulation layer being prepared from components of the following part by weight: 7.5 parts by weight of cholesteryl palmitate, 3.5 parts by weight of sodium citrate, 1 part by weight of sodium stearoyl lactylate and 0.2 part by weight of sodium stearate.
Embodiment 6
[0043] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that an anticoagulation layer is stacked on one side surface of the substrate, the anticoagulation layer being prepared from components of the following part by weight: 8.7 parts by weight of cholesteryl palmitate, 4.2 parts by weight of sodium citrate, 2 parts by weight of sodium stearoyl lactylate and 0.3 part by weight of sodium stearate.
Embodiment 7
[0044] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that an anticoagulation layer is stacked on one side surface of the substrate, the anticoagulation layer being prepared from components of the following part by weight: 10 parts by weight of cholesteryl palmitate, 5 parts by weight of sodium citrate, 3 parts by weight of sodium stearoyl lactylate and 0.5 part by weight of sodium stearate.
[0045] Both the substrate and anticoagulation layer are prepared by means of the conventional method.
[0046] Control Group 1
[0047] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 10 parts by weight of polyvinyl resin, 13 parts by weight of tourmaline powder, 0.4 part by weight of methylcellulose and 0.7 part by weight of polymethacrylic acid.
[0048] Control Group 2
[0049] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 25 parts by weight of polyvinyl resin, 0.5 part by weight of methylcellulose and 0.3 part by weight of polymethacrylic acid.
[0050] Control Group 3
[0051] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 20 parts by weight of epoxy resin, 6 parts by weight of tourmaline powder, 0.5 part by weight of methylcellulose and 0.3 part by weight of polymethacrylic acid.
[0052] Control Group 4
[0053] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 20 parts by weight of polyvinyl resin, 15 parts by weight of tourmaline powder, 0.5 part by weight of methylcellulose and 0.3 part by weight of polymethacrylic acid.
[0054] Control Group 5
[0055] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 20 parts by weight of polyvinyl resin, 6 parts by weight of tourmaline powder, 0.4 part by weight of methylcellulose and 0.3 part by weight of polymethacrylic acid.
[0056] Control Group 6
[0057] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 20 parts by weight of polyvinyl resin, 6 parts by weight of tourmaline powder, 0.8 part by weight of methylcellulose and 0.3 part by weight of polymethacrylic acid.
[0058] Control Group 7
[0059] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 20 parts by weight of polyvinyl resin, 6 parts by weight of tourmaline powder, 0.5 part by weight of methylcellulose and 0.2 part by weight of polymethacrylic acid.
[0060] Control Group 8
[0061] A special infusion pump for stem cells, the infusion pump is different from embodiment 2 in that the substrate is prepared from components of the following part by weight: 20 parts by weight of polyvinyl resin, 6 parts by weight of tourmaline powder, 0.5 part by weight of methylcellulose and 0.7 part by weight of polymethacrylic acid.
[0062] Control Group 9
[0063] A special infusion pump for stem cells, the infusion pump is different from embodiment 5 in that the anticoagulation layer is prepared from components of the following part by weight: 6 parts by weight of cholesteryl palmitate, 5.5 parts by weight of sodium citrate, 0.8 part by weight of sodium stearoyl lactylate and 0.6 part by weight of sodium stearate.
[0064] Control Group 10
[0065] A special infusion pump for stem cells, the infusion pump is different from embodiment 5 in that the anticoagulation layer is prepared from components of the following part by weight: 3.5 parts by weight of sodium oleate, 1 part by weight of sodium stearoyl lactylate and 0.2 part by weight of sodium stearate.
[0066] Control Group 11
[0067] A special infusion pump for stem cells, the infusion pump is different from embodiment 5 in that the anticoagulation layer is prepared from components of the following part by weight: 7.5 parts by weight of cholesteryl palmitate, 3.5 parts by weight of sodium citrate and 1 part by weight of sodium stearoyl lactylate.
Test Example 1
[0068] Infuse stem cells using infusion pumps for stem cells in embodiment 2-4 and control groups 1-8 respectively, and count the infusion rate of stem cells. See Table 1 for results.
TABLE-US-00001 TABLE 1 Results of infusion rate of infusion pumps for stem cell of all embodiments and control examples Group Stem cell infusion rate Embodiment 1 94.3 Embodiment 2 97.6 Embodiment 3 95.0 Control group 1 57.1 Control group 2 62.7 Control group 3 66.8 Control group 4 76.3 Control group 5 77.5 Control group 6 75.4 Control group 7 73.2 Control group 8 69.4
[0069] As shown in the Table, the substrate of the anionic protective film prepared from polyvinyl resin, tourmaline powder, methylcellulose and polymethacrylic acid provided by the present invention may prevent stem cells in the physic liquor from adhering to the inner wall of the liquor storage sac and the pipe using the effect like charges repel each other, thereby guaranteeing the infusion rate of stem cells, and if parts by weight of polyvinyl resin, tourmaline powder, methylcellulose and polymethacrylic acid are not within the scope of the present invention or the components thereof are replaced or one of the components is omitted, the infusion rate of stem cells may be affected.
Test Example 2
[0070] Observe time when protein precipitation occurs and time when hemolysis occurs in blood of stem cells infused in infusion pumps for stem cells of embodiments 5-7 and control groups 9-11. See Table 2 for results.
TABLE-US-00002 TABLE 2 Time when protein precipitation occurs and time when hemolysis occurs in stem cells in infusion pumps for stem cells of all embodiments and control examples Time when protein Time when hemolysis Group precipitation occurs h occurs h Embodiment 4 58 44 Embodiment 5 71 61 Embodiment 6 63 50 Control group 9 26 19 Control group 10 18 12 Control group 11 15 11
[0071] As shown in the Table, the anticoagulation layer prepared from cholesteryl palmitate, sodium oleate, sodium stearoyl lactylate, sodium lactate provided by the present invention can prevent blood in stem cells from coagulating, and can prolong the time when protein precipitation occurs and time when hemolysis occurs in blood to 71 h and 61 h to a maximum extent, and the anticoagulation effect can be greatly reduced when the parts by weight of cholesteryl palmitate, sodium oleate, sodium stearoyl lactylate and sodium stearate are too large or too small or the components are changed.
[0072] The above is just one preferred embodiment of the present invention and is not intended to limit the protection range of the present invention. All equal modifications and decorations made in accordance with the scope of the patent of the present invention shall still belong to the scope of the patent of the present invention.