Medical device and therapeutic method

Abstract

To provide a medical device and a therapeutic method that allow a treatment time for treating body fluid to be secured easily.SOLUTION: A medical device 1 includes: an insertion part 10 that can be inserted into a living body and defines a fluid path 10a; a storage part 20 for defining a fluid storage space 20a; and a treatment part for defining a treatment space 31a for connecting the fluid path and the fluid storage space, and treating the fluid passing through the treatment space. The treatment part includes a flow rate control mechanism that makes an inflow flow rate of inflow fluid from the fluid path to the fluid storage space that passes through the treatment space smaller than an outflow flow rate of outflow fluid from the fluid storage space to the fluid path that passes through the treatment space.SELECTED DRAWING: Figure 1

Description

[Technical Field]

[0001] FIELD OF THE DISCLOSURE The present disclosure relates to medical devices and methods of treatment. [Background technology]

[0002] Conventionally, a treatment has been known in which body fluid is collected from a living body, treated, and then reinjected into the living body. Patent Document 1 discloses a medical device used in this type of treatment.

[0003] The medical device described in Patent Document 1 comprises a harvesting device for harvesting bone marrow or other cell subset sources from a patient, including a needle for bone or vein puncture, at least one chamber for collecting, processing, and reinfusing the cell subset harvested from the patient, and an implantation device that is pre-connected or connectable to a reinfusion chamber for delivering the processed cells back to the patient. [Prior art documents] [Patent documents]

[0004] [Patent Document 1] Patent No. 4846782 Summary of the Invention [Problem to be solved by the invention]

[0005] In a medical device that processes collected body fluids, such as the medical device described in Patent Document 1, a processing space is provided and the body fluid is processed by passing it through this processing space. However, when passing the body fluid through the processing space, if the flow rate of the body fluid passing through the processing space is not sufficiently controlled, it may be difficult to ensure the processing time required to process the body fluid.

[0006] An object of the present disclosure is to provide a medical device and a treatment method that make it easier to ensure treatment time for treating bodily fluids. [Means for solving the problem]

[0007] A medical device according to a first aspect of the present disclosure comprises: (1) an insertion part that can be inserted into a living body and defines a liquid flow path; a storage section that defines a liquid storage space; a processing section that defines a processing space that connects the liquid flow path and the liquid storage space, and that is capable of processing a liquid that passes through the processing space; The processing unit is a medical device equipped with a flow control mechanism that makes the inflow flow rate of the inflow liquid flowing from the liquid flow path to the liquid storage space through the processing space smaller than the outflow flow rate of the outflow liquid flowing from the liquid storage space to the liquid flow path through the processing space.

[0008] A medical device according to one embodiment of the present disclosure comprises: (2) The flow rate control mechanism includes: an inflow path through which the inflow liquid passes in the processing space; The medical device according to (1) above, further comprising an outflow path, different from the inflow path, through which the outflow liquid passes in the processing space.

[0009] A medical device according to one embodiment of the present disclosure comprises: (3) the flow rate control mechanism includes a partition wall portion that partitions the processing space in a liquid flow direction between the liquid flow channel and the liquid storage space, the partition wall portion partitions a plurality of through holes penetrating from the liquid flow path side to the liquid storage space side, and includes an inflow prevention portion that restricts the inflow liquid from passing through some of the through holes, The medical device according to (2) above, wherein the part of the through holes constitutes the outflow path.

[0010] A medical device according to one embodiment of the present disclosure comprises: (4) the partition wall portion includes an outflow prevention portion that prevents the outflowing liquid from passing through another part of the through holes that is different from the part of the through holes, among the plurality of through holes; a flow rate at which the inflow liquid passes through the other part of the through-holes is smaller than a flow rate at which the outflow liquid passes through the part of the through-holes; The medical device according to (3) above, wherein the other part of the through holes constitutes the inflow path.

[0011] A medical device according to one embodiment of the present disclosure comprises: (5) The medical device according to (2) above, wherein the inflow path is longer than the outflow path.

[0012] A medical device according to one embodiment of the present disclosure comprises: (6) The flow rate control mechanism includes: an inflow path through which the inflow liquid passes in the processing space; The medical device according to (1) above, further comprising an outflow path through which the outflow liquid passes in the processing space, the outflow path being a bypass path added to the inflow path.

[0013] A medical device according to one embodiment of the present disclosure comprises: (7) The medical device according to (6) above, wherein the flow rate control mechanism comprises a porous member that is disposed in the inflow path of the processing space and is not disposed in the bypass path.

[0014] A medical device according to one embodiment of the present disclosure comprises: (8) The medical device according to any one of (1) to (7) above, wherein the insertion part is a puncture needle capable of puncturing bone.

[0015] A medical device according to one embodiment of the present disclosure comprises: (9) The medical device according to any one of (1) to (8) above, wherein the processing section is capable of performing a cell killing process to kill cells in the inflow liquid.

[0016] A medical device according to one embodiment of the present disclosure comprises: (10) The medical device according to any one of (1) to (9) above, further comprising a supply section capable of supplying a therapeutic substance to the inflow liquid that passes through the processing space and is stored in the liquid storage space.

[0017] A method of treatment according to a second aspect of the present disclosure includes: (11) A treatment method using the medical device according to any one of (1) to (10) above, an insertion step of inserting the insertion portion into the living body; a suction treatment step of suctioning the body fluid from the living body as the inflow liquid through the liquid flow path and passing the body fluid through the treatment space to treat the body fluid; and an injection step of injecting the body fluid that has passed through the treatment space and been stored in the liquid storage space as the outflow liquid into the living body through the treatment space and the liquid flow path. [Effects of the Invention]

[0018] According to the present disclosure, it is possible to provide a medical device and a treatment method that make it easy to ensure the treatment time for treating bodily fluids. [Brief explanation of the drawings]

[0019] [Figure 1] 1A and 1B are diagrams illustrating a medical device according to a first embodiment of the present disclosure. [Figure 2A] FIG. 2 is a diagram showing a state in which the medical device shown in FIG. 1 is aspirating bone marrow fluid from within the bone marrow through a puncture needle serving as an insertion part. [Figure 2B] FIG. 2 is a diagram showing a state in which the medical device shown in FIG. 1 is injecting a liquid into bone marrow through a puncture needle serving as an insertion part. [Figure 3A]FIG. 2 is a diagram illustrating details of a processing unit shown in FIG. [Figure 3B] FIG. 3B is a diagram showing a state in which an inflow liquid passes through a processing space of the processing section shown in FIG. 3A. [Figure 3C] 3B is a diagram showing a state in which outflowing liquid passes through a processing space of the processing section shown in FIG. 3A. FIG. [Figure 4] 2 is a flowchart illustrating an example of a treatment method performed using the medical device shown in FIG. 1. [Figure 5A] FIG. 10 is a view showing a part of a treatment section of a medical device according to a second embodiment of the present disclosure, showing a state in which an inflow liquid passes through the treatment space. [Figure 5B] FIG. 5B is a diagram showing a state in which outflowing liquid passes through a processing space of the processing section shown in FIG. 5A. [Figure 6A] FIG. 10 is a view showing a part of a treatment section of a medical device according to a third embodiment of the present disclosure, showing a state in which an inflow liquid passes through the treatment space. [Figure 6B] FIG. 6B is a diagram showing a state in which outflowing liquid passes through a processing space of the processing section shown in FIG. 6A. [Figure 7] FIG. 6B is a diagram showing details of the flow path forming portion shown in FIG. 6A. DETAILED DESCRIPTION OF THE INVENTION

[0020] Hereinafter, embodiments of a medical device and a treatment method according to the present disclosure will be illustrated and described with reference to the drawings. In each drawing, the same components are designated by the same reference numerals.

[0021] First Embodiment FIG. 1 is a diagram illustrating a medical device 1 as a first embodiment of a medical device according to the present disclosure. As illustrated in FIG. 1, the medical device 1 includes an insertion section 10, a storage section 20, a processing section 30, a pressure adjustment section 40, a supply section 41, a blocking member 42, and a valve body 43. FIGS. 2A and 2B are diagrams illustrating an example of a method of using the medical device 1. The medical device 1 illustrated in FIGS. 2A and 2B is used for a treatment in which a lymphocyte-depleted environment is created in a localized area within bone marrow 81 and immune cells are transplanted. FIGS. 2A and 2B illustrate the medical device 1 in a state in which a puncture needle 11 serving as the insertion section 10 has been inserted into a bone 80 and reached the bone marrow 81. In particular, FIG. 2A illustrates the medical device 1 aspirating bone marrow fluid from the bone marrow 81 through the puncture needle 11 serving as the insertion section 10. FIG. 2B illustrates the medical device 1 injecting fluid into the bone marrow 81 through the puncture needle 11 serving as the insertion section 10. In the following, in this embodiment, the case where the medical device 1 is used in the manner shown in Figures 2A and 2B will be described as an example, but the manner of use of the medical device according to the present disclosure is not limited to the manner of use shown in Figures 2A and 2B.

[0022] [Insertion part 10] The insertion part 10 can be inserted into a living body 70. The insertion part 10 defines a liquid flow path 10a. The insertion part 10 of this embodiment has an elongated tubular shape and defines the liquid flow path 10a that penetrates in the length direction. The insertion part 10 of this embodiment is a puncture needle 11 that can be inserted into a bone 80.

[0023] The medical device 1 can aspirate bodily fluids from the living body 70 through the insertion section 10 inserted into the living body 70. The medical device 1 can also inject liquid into the living body 70 through the insertion section 10 inserted into the living body 70. More specifically, the medical device 1 of this embodiment can aspirate bone marrow fluid from the bone marrow 81 through the puncture needle 11 serving as the insertion section 10 that is punctured into the bone 80 and inserted until it reaches the bone marrow 81. The medical device 1 of this embodiment can also inject liquid into the bone marrow 81 through the puncture needle 11 serving as the insertion section 10 that is punctured into the bone 80 and inserted until it reaches the bone marrow 81.

[0024] The insertion part 10 of this embodiment is a puncture needle 11 that can puncture bone 80, but the configuration of the insertion part 10 is not particularly limited as long as it can be inserted into a living body 70 and defines a liquid flow path 10a.

[0025] [Storage section 20] The reservoir 20 defines a liquid storage space 20a capable of storing liquid. The reservoir 20 may be made of, for example, a hard or soft resin container.

[0026] The liquid storage space 20a is connected to the liquid flow path 10a. More specifically, the storage unit 20 of this embodiment is connected to the insertion unit 10 via a tube serving as the connecting member 25. The liquid storage space 20a of this embodiment is connected to the liquid flow path 10a via the hollow portion of the tube serving as the connecting member 25. However, the configuration for connecting the storage unit 20 and the insertion unit 10 is not particularly limited as long as the liquid flow path 10a and the liquid storage space 20a can be communicated with each other.

[0027] For ease of explanation, hereinafter, the liquid flowing from the liquid flow channel 10a to the liquid storage space 20a (see the thick arrow in FIG. 2A) may be referred to as the "inflow liquid W1," and the liquid flowing from the liquid storage space 20a to the liquid flow channel 10a (see the thick arrow in FIG. 2B) may be referred to as the "outflow liquid W2." The direction in which the liquid moves between the liquid flow channel 10a and the liquid storage space 20a may be referred to as the "liquid movement direction A." Furthermore, within the liquid movement direction A, the direction from the liquid flow channel 10a to the liquid storage space 20a may be referred to as the "liquid storage space side A1," and the direction from the liquid storage space 20a to the liquid flow channel 10a may be referred to as the "liquid flow channel side A2."

[0028] [Processing section 30] Fig. 3A is a diagram showing details of the processing unit 30 of this embodiment. Fig. 3B shows a state in which inflow liquid W1 passes through the processing space 31a of the processing unit 30 shown in Fig. 3A. Fig. 3C shows a state in which outflow liquid W2 passes through the processing space 31a of the processing unit 30 shown in Fig. 3A. As shown in Figs. 3A to 3C, the processing unit 30 of this embodiment includes a processing case 31, a processing device 32, and a flow rate control mechanism 34.

[0029] The processing case portion 31 defines a processing space 31a. The processing space 31a connects the liquid flow path 10a and the liquid storage space 20a. Therefore, the inflow liquid W1 passes through the processing space 31a on its way from the liquid flow path 10a to the liquid storage space 20a. The outflow liquid W2 passes through the processing space 31a on its way from the liquid storage space 20a to the liquid flow path 10a. The processing case portion 31 of this embodiment may be formed, for example, of a hard or soft resin container. The resin container serving as the processing case portion 31 may be disposed inside the resin container serving as the storage portion 20, as in this embodiment, or may serve as the resin container serving as the storage portion 20. The resin container serving as the processing case portion 31 may also be a separate body from the resin container serving as the storage portion 20.

[0030] The processing device 32 is capable of processing the liquid passing through the processing space 31a. The processing device 32 of this embodiment is capable of performing a cell killing process to kill cells in the inflow liquid W1 flowing from the liquid flow path 10a to the liquid storage space 20a. Examples of cell killing processes include electrical treatment, radiation treatment, and heat treatment. However, the process performed by the processing device 32 is not particularly limited. As an example, the processing device 32 of this embodiment is a radiation irradiation device 33 that is capable of irradiating radiation to the liquid passing through the processing space 31a.

[0031] The flow rate control mechanism 34 sets the inflow rate of inflow liquid W1 from the liquid flow path 10a to the liquid storage space 20a through the processing space 31a to be smaller than the outflow rate of outflow liquid W2 from the liquid storage space 20a to the liquid flow path 10a through the processing space 31a. The "inflow rate of inflow liquid W1 passing through the processing space 31a" refers to the amount of inflow liquid W1 passing through the processing space 31a per unit time. Additionally, the "outflow rate of outflow liquid W2 passing through the processing space 31a" refers to the amount of outflow liquid W2 passing through the processing space 31a per unit time.

[0032] More specifically, the flow rate control mechanism 34 of this embodiment includes an inflow path L1 through which the inflow liquid W1 passes into the processing space 31a, and an outflow path L2, different from the inflow path L1, through which the outflow liquid W2 passes into the processing space 31a. The flow rate control mechanism 34 of this embodiment is configured so that the inflow rate of the inflow liquid W1 passing through the inflow path L1 is smaller than the outflow rate of the outflow liquid W2 passing through the outflow path L2. In this case, the pressure acting on the processing space 31a to suck the inflow liquid W1 and the pressure acting on the outflow liquid W2 are set to be equal.

[0033] More specifically, the flow rate control mechanism 34 of this embodiment includes a partition wall portion 35. The partition wall portion 35 of this embodiment includes a partition main body portion 36, an inflow prevention portion 37, and an outflow prevention portion 38.

[0034] The partition main body 36 separates the processing space 31a in the liquid flow direction A between the liquid flow path 10a and the liquid storage space 20a. The partition main body 36 may be formed, for example, of a resin membrane. However, the configuration of the partition main body 36 is not particularly limited as long as it can separate the processing space 31a. The partition main body 36 defines a plurality of through holes 36a that penetrate from the liquid flow path side A2 to the liquid storage space side A1. The partition main body 36 of this embodiment defines five through holes 36a.

[0035] The inflow prevention portion 37 prevents the inflow liquid W1 from passing through some of the through holes 36a among the plurality of through holes 36a partitioned by the partition wall portion 35. On the other hand, the inflow prevention portion 37 does not prevent the outflow liquid W2 from passing through the some of the through holes 36a. Hereinafter, for ease of explanation, the "some of the through holes 36a" will be referred to as outflow through holes 36a1.

[0036] In other words, the inflow prevention portion 37 prevents the inflow liquid W1 from passing through the outflow through-hole 36a1 among the plurality of through-holes 36a partitioned by the partition wall portion 35. On the other hand, the outflow liquid W2 can pass through the outflow through-hole 36a1. In other words, the outflow through-hole 36a1 forms the outflow path L2.

[0037] The inflow prevention unit 37 of this embodiment prevents the inflow liquid W1 from passing through one through-hole 36a, which serves as the outflow through-hole 36a1, among the five through-holes 36a defined by the partition wall unit 35. The inflow prevention unit 37 of this embodiment is configured by a check valve provided in the one through-hole 36a. However, the configuration of the inflow prevention unit 37 is not particularly limited as long as it prevents the inflow liquid W1 from passing through some of the through-holes 36a among the plurality of through-holes 36a defined by the partition wall unit 35.

[0038] The outflow prevention unit 38 prevents the outflow liquid W2 from passing through another part of the through holes 36a, which are different from the outflow through holes 36a1 of the plurality of through holes 36a through which the inflow liquid W1 is prevented from passing by the inflow prevention unit 37. On the other hand, the outflow prevention unit 38 does not prevent the inflow liquid W1 from passing through the other part of the through holes 36a. Hereinafter, for ease of explanation, the "other part of the through holes 36a" will be referred to as the inflow through holes 36a2.

[0039] In other words, the outflow prevention portion 38 prevents the outflow liquid W2 from passing through the inflow through hole 36a2, which is different from the outflow through hole 36a1, among the multiple through holes 36a partitioned by the partition wall portion 35. On the other hand, the inflow liquid W1 can pass through the inflow through hole 36a2. In other words, the inflow through hole 36a2 forms the inflow path L1.

[0040] Furthermore, the flow rate at which the inflow liquid W1 passes through the inflow through hole 36a2 is smaller than the flow rate at which the outflow liquid W2 passes through the outflow through hole 36a1. In this way, the inflow flow rate of the inflow liquid W1 passing through the inflow path L1 can be made smaller than the outflow flow rate of the outflow liquid W2 passing through the outflow path L2. Note that when the multiple through holes 36a partitioned by the partition wall portion 35 include through holes 36a other than the outflow through hole 36a1 and the inflow through hole 36a2, the inflow flow rate and outflow flow rate of the liquid passing through these through holes 36a are the same.

[0041] The outflow prevention unit 38 of this embodiment prevents the outflow liquid W2 from passing through four through-holes 36a serving as inflow through-hole 36a2, which are different from the one through-hole 36a serving as outflow through-hole 36a1, among the five through-holes 36a partitioned by the partition wall unit 35. The outflow prevention unit 38 of this embodiment is configured by a check valve provided in each of the four through-holes 36a. However, the configuration of the outflow prevention unit 38 is not particularly limited as long as it prevents the outflow liquid W2 from passing through the inflow through-hole 36a2, which is different from the outflow through-hole 36a1, among the multiple through-holes 36a, and makes the flow rate of the inflow liquid W1 passing through the inflow through-hole 36a2 smaller than the flow rate of the outflow liquid W2 passing through the outflow through-hole 36a1.

[0042] The number and size of the through holes 36a partitioned by the partition wall portion 35 are not particularly limited. Furthermore, the inflow flow rate of the inflow liquid W1 usually needs to be adjusted more accurately than the outflow flow rate of the outflow liquid W2. From this perspective, it is preferable that the inflow through holes 36a2 have a smaller diameter than the outflow through holes 36a1. This makes it easier to fine-tune the inflow flow rate of the inflow liquid W1. It is also preferable that the number of inflow through holes 36a2 is greater than the number of outflow through holes 36a1. This makes it easier to fine-tune the inflow flow rate of the inflow liquid W1.

[0043] The flow rate control mechanism 34 of this embodiment includes three partition wall portions 35 spaced apart in the liquid movement direction A. As a result, the processing space 31a of this embodiment is partitioned by the three partition wall portions 35 and divided into four spaces. However, the number of partition wall portions 35 is not particularly limited.

[0044] In this embodiment, the partition wall 35 includes both the inflow prevention portion 37 and the outflow prevention portion 38, but this configuration is not limited thereto. The partition wall 35 may also include the inflow prevention portion 37 but not the outflow prevention portion 38. In such a case, the plurality of through holes 36a defined by the partition wall 35 include the outflow through hole 36a1 but not the inflow through hole 36a2. The inflow flow rate and outflow flow rate of the liquid passing through the through holes 36a other than the outflow through hole 36a1 among the plurality of through holes 36a defined by the partition wall 35 are the same. In this way, even if the partition wall 35 includes the inflow prevention portion 37 but not the outflow prevention portion 38, the inflow flow rate of the inflow liquid W1 passing through the inflow path L1 can be made smaller than the outflow flow rate of the outflow liquid W2 passing through the outflow path L2.

[0045] [Pressure adjustment unit 40] The pressure adjusting unit 40 can selectively pressurize and depressurize the liquid storage space 20a. As shown in FIGS. 1 to 2B, the pressure adjusting unit 40 of this embodiment is a syringe connected to the storage unit 20. By pulling the plunger of the syringe toward the cylindrical body, the liquid storage space 20a can be depressurized and bone marrow fluid can be aspirated from the bone marrow 81 (see FIG. 2A). Conversely, by pushing the plunger of the syringe toward the cylindrical body, the liquid storage space 20a can be pressurized and the liquid stored in the liquid storage space 20a can be injected into the bone marrow 81 (see FIG. 2B). However, the configuration of the pressure adjusting unit 40 is not particularly limited as long as it can selectively pressurize and depressurize the liquid storage space 20a.

[0046] [Supply section 41] The supply unit 41 is capable of supplying a therapeutic substance to the inflow liquid W1 passing through the processing space 31a and stored in the liquid storage space 20a. In this embodiment, the supply unit 41 is a syringe connected to the storage unit 20. However, the configuration of the supply unit 41 is not particularly limited as long as it is capable of supplying a therapeutic substance to the inflow liquid W1 passing through the processing space 31a and stored in the liquid storage space 20a. Therapeutic substances that can be supplied by the supply unit 41 include, for example, cells derived from somatic stem cells (adult stem cells), mesenchymal stem cells, or iPS cells (induced pluripotent stem cells), and more preferably immune cells derived from hematopoietic stem cells (HSCs). Therapeutic substances that can be supplied by the supply unit 41 may include, for example, physiologically active substances, growth factors, molecular targeted drugs, immunosuppressants, etc., instead of or in addition to the above-mentioned cells.

[0047] [Blocking member 42] The closing member 42 is capable of closing the flow path between the liquid flow path 10a and the processing space 31a in the liquid movement direction A. By including the closing member 42, the medical device 1 can prevent the inflow liquid W1 stored in the liquid storage space 20a from being pushed out toward the liquid flow path side A2 and flowing into the liquid flow path 10a when the supply unit 41 supplies predetermined cells to the inflow liquid W1 stored in the liquid storage space 20a. The closing member 42 may be, for example, a clamp that can tighten from the outside a resin tube connecting the insertion unit 10 and the processing unit 30 to close the hollow portion of the tube. However, the configuration of the closing member 42 is not particularly limited as long as it is capable of closing the flow path between the liquid flow path 10a and the processing space 31a in the liquid movement direction A.

[0048] [Valve body 43] The valve element 43 can adjust the pressure in the liquid storage space 20a. By providing the valve element 43, it is possible to prevent the pressure in the liquid storage space 20a from increasing excessively when the supply unit 41 supplies predetermined cells to the inflow liquid W1 stored in the liquid storage space 20a. The valve element 43 may be, for example, a pressure reducing valve for the liquid. However, the configuration of the valve element 43 is not particularly limited as long as it is capable of adjusting the pressure in the liquid storage space 20a.

[0049] Next, a description will be given of a treatment method as one embodiment of the treatment method according to the present disclosure using the above-described medical device 1. Fig. 4 is a flowchart showing the treatment method of this embodiment.

[0050] As shown in FIG. 4, the treatment method of this embodiment includes an inserting step S1, a suctioning step S2, a treatment substance supplying step S3, and an injection step S4.

[0051] [Insertion process S1] In the insertion step S1, the insertion section 10 is inserted into the living body 70. In the insertion step S1 of this embodiment, the puncture needle 11 as the insertion section 10 is inserted into the bone 80 to be treated, and is inserted until it reaches the bone marrow 81.

[0052] [Suction processing process S2] The suction process S2 is performed while the insertion section 10 is inserted into the living organism 70. In the suction process S2, bodily fluid within the living organism 70 is aspirated as the inflow liquid W1 through the liquid flow path 10a of the insertion section 10. More specifically, in the suction process S2 of this embodiment, a syringe serving as the pressure adjusting unit 40 is operated to reduce the pressure within the liquid storage space 20a. This also reduces the pressure within the liquid flow path 10a connected to the liquid storage space 20a. As a result, the bodily fluid within the living organism 70 as the inflow liquid W1 (bone marrow fluid in this embodiment) can be aspirated through the liquid flow path 10a. The aspirated bodily fluid as the inflow liquid W1 flows from the liquid flow path 10a to the liquid storage space 20a and passes through the processing space 31a on the way from the liquid flow path 10a to the liquid storage space 20a.

[0053] In the processing unit 30, the processing device 32 is already running. Therefore, the body fluid as the inflow liquid W1 is processed by the processing device 32 as it passes through the processing space 31a. In this manner, in the suction processing step S2 of this embodiment, the body fluid as the inflow liquid W1 can be continuously processed by passing the body fluid as the inflow liquid W1 through the processing space 31a. After passing through the processing space 31a, the body fluid as the inflow liquid W1 is stored in the liquid storage space 20a of the storage unit 20.

[0054] In the suction process step S2 of this embodiment, bone marrow fluid as the inflow liquid W1 is aspirated through the liquid flow path 10a of the puncture needle 11 as the insertion section 10. The aspirated bone marrow fluid passes through the processing space 31a, whereby a cell killing process is performed. More specifically, in the suction process step S2 of this embodiment, the bone marrow fluid passing through the processing space 31a is subjected to radiation processing by the radiation irradiation device 33 as the processing device 32, thereby killing the cells in the bone marrow fluid. After passing through the processing space 31a, the bone marrow fluid as the inflow liquid W1 is stored in the liquid storage space 20a.

[0055] [Treatment substance supply process S3] In the therapeutic substance supply step S3, the therapeutic substance is supplied to the body fluid that has passed through the processing space 31a and accumulated in the liquid storage space 20a. In the therapeutic substance supply step S3 of this embodiment, a syringe serving as the supply unit 41 is operated to supply immune cells as the therapeutic substance to the bone marrow fluid that has passed through the processing space 31a and accumulated in the liquid storage space 20a.

[0056] [Injection process S4] In the injection step S4, the body fluid that has passed through the treatment space 31a and accumulated in the liquid storage space 20a is injected as outflow liquid W2 into the living organism 70 through the treatment space 31a and the liquid flow path 10a. In the suction treatment step S2 of this embodiment, the syringe serving as the pressure adjustment unit 40 is operated to pressurize the inside of the liquid storage space 20a. This pushes out the body fluid that has accumulated in the liquid storage space 20a, and the body fluid can be injected as outflow liquid W2 into the living organism 70 through the treatment space 31a and the liquid flow path 10a.

[0057] The injection step S4 of this embodiment is performed after the therapeutic substance supply step S3. Furthermore, the injection step S4 of this embodiment is performed without removing the puncture needle 11, which serves as the insertion section 10 inserted into the bone marrow 81 in the insertion step S1. Therefore, in the injection step S4 of this embodiment, the bone marrow fluid that has passed through the processing space 31a and been stored in the liquid storage space 20a and to which immune cells have been supplied is injected as outflow liquid W2 into the bone marrow 81 through the processing space 31a and the liquid flow path 10a. In particular, when injecting into the bone marrow 81, by injecting into the same site as the site from which the bone marrow fluid was aspirated in the suction processing step S2, the space from which blood cells such as lymphocytes have been physically removed can be utilized, thereby more efficiently creating a lymphocyte eradication environment.

[0058] As described above, the treatment method of this embodiment may be performed without removing the insertion unit 10 inserted into the living body 70 in the insertion step S1 until the injection step S4. In this way, the burden on the living body 70 can be reduced compared to the case where the insertion unit 10 is removed before the injection step S4, and then the insertion unit 10 is inserted into the living body 70 again before the injection step S4 is performed.

[0059] Furthermore, in the treatment method of this embodiment, the above-mentioned steps from the suction process step S2 to the injection process step S4 can be performed within the closed space of the medical device 1, which includes the liquid flow path 10a, the liquid storage space 20a, and the processing space 31a. This reduces the risk of contamination, such as foreign matter being mixed into the body fluid suctioned from the living body 70.

[0060] As described above, the medical device 1 of this embodiment includes a processing unit 30 that defines a processing space 31a connecting the liquid flow path 10a and the liquid storage space 20a and can process the liquid passing through the processing space 31a. By including such a processing unit 30, the inflow liquid W1 sucked through the liquid flow path 10a can be processed simply by passing it through the processing space 31a. This allows the inflow liquid W1 to be processed in parallel with the inflow liquid W1 being sucked, thereby enabling efficient processing of the inflow liquid W1. Furthermore, the volume of the processing space 31a can be made smaller than the total amount of inflow liquid W1 to be processed by the processing unit 30, thereby enabling the medical device 1 to be simplified and miniaturized.

[0061] Furthermore, the medical device 1 of this embodiment includes a flow rate control mechanism 34 that reduces the inflow rate of the inflow liquid W1 flowing from the liquid flow path 10a to the liquid storage space 20a through the processing space 31a compared to the outflow rate of the outflow liquid W2 flowing from the liquid storage space 20a to the liquid flow path 10a through the processing space 31a. This allows the inflow rate of the inflow liquid W1 flowing from the liquid flow path 10a to the liquid storage space 20a to pass through the processing space 31a to be reduced compared to the outflow rate of the outflow liquid W2 flowing from the liquid storage space 20a to the liquid flow path 10a to pass through the processing space 31a. As a result, the time required for the inflow liquid W1 to pass through the processing space 31a can be made longer than the time required for the outflow liquid W2 to pass through the processing space 31a. This makes it easier to ensure the processing time required to process the body fluid used as the inflow liquid W1.

[0062] Second Embodiment Next, a medical device 100 as a second embodiment will be described with reference to Figures 5A and 5B. The medical device 100 of this embodiment differs from the medical device 1 of the first embodiment described above in the configuration of the flow control mechanism, but the other configurations are the same. Here, the above-mentioned differences will be mainly described, and a description of the configurations common to the medical device 1 will be omitted.

[0063] 5A and 5B are diagrams showing a portion of the processing section 130 of the medical device 100. In particular, FIG. 5A shows a state in which the inflow liquid W1 passes through the processing space 131a. Also, FIG. 5B shows a state in which the outflow liquid W2 passes through the processing space 131a. As shown in FIGS. 5A and 5B, the flow rate control mechanism 134 of this embodiment includes an inflow path L11 through which the inflow liquid W1 passes in the processing space 131a, and an outflow path L12 through which the outflow liquid W2 passes in the processing space 131a.

[0064] The outflow path L12 in this embodiment is configured by adding a bypass path L12b, through which liquid can pass, to the inflow path L11 (the same path as the inflow path L11 designated by the reference symbol "12a" in FIG. 5B). This allows the outflow liquid W2 passing through the outflow path L12 to flow more easily than the inflow liquid W1 passing through the inflow path L11. As a result, the inflow flow rate of the inflow liquid W1 passing through the processing space 131a can be made smaller than the outflow flow rate of the outflow liquid W2 passing through the processing space 131a.

[0065] 5A and 5B, the flow rate control mechanism 134 of this embodiment includes a porous member 150. The porous member 150 is disposed in the processing space 131a. The porous member 150 may be formed, for example, from a sponge having internal voids with an open-cell structure.

[0066] The porous member 150 is disposed in the inflow path L11 of the processing space 131a, but is not disposed in the bypass path L12b. More specifically, when the inflow liquid W1 passes through the processing space 131a, the inner surface of the processing case portion 131 that defines the processing space 131a is adhered to the porous member 150 so as to cover the outer surface of the porous member 150. Therefore, when the inflow liquid W1 passes through the processing space 131a, it passes through the porous member 150 disposed in the inflow path L11. On the other hand, when the outflow liquid W2 passes through the processing space 131a, the adhesion between the inner surface of the processing case portion 131 and the outer surface of the porous member 150 is released. Therefore, when the outflow liquid W2 passes through the processing space 131a, it can pass through the space between the outer surface of the porous member 150 and the inner surface of the processing case portion 131, which serves as the bypass path L12b, in addition to the porous member 150 disposed in the inflow path L11. That is, the outflow liquid W2 can pass through both the path L12a, which is the same as the inflow path L11 in which the porous member 150 is disposed, and the bypass path L12b, which does not have the porous member 150. In this way, by disposing the porous member 150 on the inflow path L11 of the processing space 131a and not on the bypass path L12b, the inflow liquid W1 passing through the inflow path L11 can flow more slowly than the outflow liquid W2 passing through the outflow path L12. This allows the inflow flow rate of the inflow liquid W1 passing through the processing space 131a to be smaller than the outflow flow rate of the outflow liquid W2 passing through the processing space 131a.

[0067] In addition, when the detour path L12b is formed, a portion of the porous member 150 in this embodiment is connected to the treatment case portion 131. More specifically, in this embodiment, when the detour path L12b is formed, there is a portion where the adhesion between the inner surface of the treatment case portion 131 and the outer surface of the porous member 150 is not released and maintained. Hereinafter, for convenience of explanation, this portion will be referred to as a "strongly bonded portion." This restricts movement of the porous member 150 within the treatment space 131a and suppresses misalignment of the porous member 150. As described above, in this embodiment, the porous member 150 and the treatment case portion 131 are connected by a strongly bonded portion, but this configuration is not limited to this. Other configurations, such as mechanical connection using a connecting member, may be used as long as the connection between the porous member 150 and the treatment case portion 131 is maintained when the detour path L12b is formed.

[0068] In this embodiment, a weakly bonded portion is provided between the inner surface of the treatment case portion 131 and the outer surface of the porous member 150, for example, by heat fusion, with a bonding strength weaker than that of the strongly bonded portion. More specifically, the weakly bonded portion is bonded so that the bonded state is released by an external force or the fluid pressure of the outflowing liquid W2 passing through the treatment space 131a. Note that the weakly bonded portion only needs to be formed between at least the outer surface of the porous member 150 in a direction perpendicular to the liquid movement direction A and the inner surface of the treatment case portion 131. In other words, the weakly bonded portion does not necessarily have to be formed between the outer surface of the porous member 150 in a direction parallel to the liquid movement direction A and the inner surface of the treatment case portion 131. Furthermore, the porous member 150 may be arranged to extend to the inlet / outlet of the treatment space 131a, through which the inflowing liquid W1 flows in or the outflowing liquid W2 flows out. In other words, in a state where the bypass path L12b is formed, the bypass path L12b does not have to be sandwiched between the porous member 150 and the inlet / outlet of the processing space 131a.

[0069] In this embodiment, the above-described configuration realizes a configuration in which the porous member 150 is disposed only on the inflow path L11 of the processing space 131a. However, the configuration in which the porous member 150 is disposed only on the inflow path L11 of the processing space 131a is not limited to the above.

[0070] <Third embodiment> Next, a medical device 200 as a third embodiment will be described with reference to Figures 6A, 6B, and 7. The medical device 200 of this embodiment differs from the medical device 1 of the first embodiment described above in the configuration of the flow control mechanism, but the other configurations are the same. Here, the above-mentioned differences will be mainly described, and a description of the configurations common to the medical device 1 will be omitted.

[0071] 6A and 6B are diagrams showing a part of the processing section 230 of the medical device 200. In particular, Fig. 6A shows a state in which the inflow liquid W1 passes through the processing space 231a. Fig. 6B shows a state in which the outflow liquid W2 passes through the processing space 231a. Fig. 7 is a diagram showing details of the flow path forming section 250 shown in Fig. 6A.

[0072] 6A and 6B, the flow rate control mechanism 234 of this embodiment includes an inflow path L21 through which the inflow liquid W1 passes in the processing space 231a, and an outflow path L22 through which the outflow liquid W2 passes in the processing space 231a. The outflow path L22 of this embodiment is a path different from the inflow path L21.

[0073] In this embodiment, the inflow path L21 is longer than the outflow path L22. More specifically, as shown in FIGS. 6A and 6B, the flow rate control mechanism 234 of this embodiment includes a flow path forming part 250. The flow path forming part 250 is disposed in the processing space 231a. As shown in FIG. 7, the flow path forming part 250 defines a serpentine flow path 250a through which a liquid can pass and which bends at multiple positions in the extension direction.

[0074] When the inflow liquid W1 passes through the processing space 231a, the flow path forming unit 250 is positioned so that the serpentine flow path 250a is included in the inflow path L21. On the other hand, when the outflow liquid W2 passes through the processing space 231a, the flow path forming unit 250 is positioned so that the serpentine flow path 250a is not included in the outflow path L22. As a result, the inflow path L21 is longer than the outflow path L22 by the amount that includes the serpentine flow path 250a. By making the inflow path L21 longer than the outflow path L22, the inflow liquid W1 passing through the inflow path L21 can flow more slowly than the outflow liquid W2 passing through the outflow path L22. This makes it possible to reduce the inflow flow rate of the inflow liquid W1 passing through the processing space 231a compared to the outflow flow rate of the outflow liquid W2 passing through the processing space 231a. Note that when the inflow liquid W1 passes through the processing space 231a, the flow path forming unit 250 may be positioned so that the inflow path L21 is composed of only the serpentine flow path 250a.

[0075] The flow path forming unit 250 of this embodiment is configured so that its position in the processing space 231a changes due to an external force applied from outside the processing case unit 231. In this embodiment, by providing such a flow path forming unit 250, a configuration is realized in which the inflow path L21 is longer than the outflow path L22. The cross-sectional area of ​​the serpentine flow path 250a defined by the flow path forming unit 250 of this embodiment is smaller than the cross-sectional area of ​​an arbitrary position of the outflow path L22. This configuration can further reduce the inflow flow rate of the inflow liquid W1 passing through the processing space 231a. As a result, it is easier to ensure the processing time for processing the body fluid as the inflow liquid W1. However, the configuration in which the inflow path L21 is longer than the outflow path L22 is not limited to the above. Furthermore, the configuration of the flow path forming unit 250 is not particularly limited as long as it is possible to make the inflow path L21 longer than the outflow path L22.

[0076] The medical device and treatment method according to the present disclosure are not limited to the specific configurations shown in the above-described embodiments and modifications, and various modifications, alterations, and combinations are possible without departing from the scope of the claims.

[0077] 5A and 5B show a configuration in which the porous member 150 is used to form the outflow path L12, which is the same path L12a as the inflow path L11, with the addition of a detour path L12b. However, the inflow path L11 and the outflow path L12 may be different paths by, for example, disposing a member through which the inflow liquid W1 can pass but the outflow liquid W2 cannot pass, instead of the porous member 150. Furthermore, the inflow path L11 and the outflow path L12 may be different paths while using the porous member 150, for example, by increasing the fluid resistance when the liquid passes through the porous member 150 and decreasing the fluid resistance when the liquid passes through the detour path L12b. [Industrial Applicability]

[0078] The present disclosure relates to medical devices and methods of treatment. [Explanation of symbols]

[0079] 1, 100, 200: Medical devices 10: Insertion section 10a: Liquid flow path 11: Puncture needle 20: Storage section 20a: Liquid storage space 25: Connection parts 30, 130, 230: Processing section 31, 131, 231: Processing case part 31a, 131a, 231a: Processing space 32: Processing device 33: Radiation irradiation device 34, 134, 234: Flow control mechanism 35: Partition wall 36: Partition body 36a: Through hole 36a1: Outflow through hole 36a2: Inflow through hole 37:Inflow prevention part 38: Outflow prevention section 40: Pressure adjustment section 41: Supply section 42: Closure member 43: Valve body 70: Living organisms 80: Bone 81: Bone marrow 150: Porous material 250: Flow path forming section 250a: Serpentine flow path A: Liquid movement direction A1: Liquid storage space side in the direction of liquid movement A2: Liquid flow path side in the direction of liquid flow L1, L11, L21: Inflow route L2, L12, L22: Outflow pathway L12a: The same path as the inflow path through which the outflow liquid passes L12b: Detour route S1: Insertion process S2: Suction processing process S3: Treatment substance supply process S4: Injection process W1: Inflow liquid W2: spilled liquid

Claims

1. an insertion part that can be inserted into a living body and defines a liquid flow path; a storage section that defines a liquid storage space; a processing section that defines a processing space that connects the liquid flow path and the liquid storage space, and that is capable of processing a liquid that passes through the processing space; The processing unit is a medical device equipped with a flow control mechanism that makes the inflow flow rate of inflow liquid flowing from the liquid flow path to the liquid storage space through the processing space smaller than the outflow flow rate of outflow liquid flowing from the liquid storage space to the liquid flow path through the processing space.

2. The flow rate control mechanism includes: an inflow path through which the inflow liquid passes in the processing space; The medical device of claim 1 , further comprising an outlet path, different from the inlet path, through which the outflow liquid passes in the processing space.

3. the flow rate control mechanism includes a partition wall portion that partitions the processing space in a liquid flow direction between the liquid flow channel and the liquid storage space, the partition wall portion partitions a plurality of through holes penetrating from the liquid flow path side to the liquid storage space side, and includes an inflow prevention portion that restricts the inflow liquid from passing through some of the through holes, The medical device according to claim 2 , wherein the portion of the through holes constitutes the outflow path.

4. the partition wall portion includes an outflow prevention portion that prevents the outflowing liquid from passing through another part of the through holes that is different from the part of the through holes, among the plurality of through holes; a flow rate at which the inflow liquid passes through the other part of the through-holes is smaller than a flow rate at which the outflow liquid passes through the part of the through-holes; The medical device according to claim 3 , wherein the other part of the through holes constitutes the inflow path.

5. The medical device of claim 2 , wherein the inflow path is longer than the outflow path.

6. The flow rate control mechanism includes: an inflow path through which the inflow liquid passes in the processing space; The medical device according to claim 1 , further comprising: an outflow path through which the outflow liquid passes in the processing space, the outflow path being a bypass path added to the inflow path.

7. The medical device of claim 6 , wherein the flow control mechanism comprises a porous member disposed in the inlet path of the processing space and not disposed in the bypass path.

8. The medical device according to any one of claims 1 to 7, wherein the insertion portion is a puncture needle that can be inserted into a bone.

9. The medical device according to any one of claims 1 to 7, wherein the processing unit is capable of performing a cell killing process to kill cells in the inflow liquid.

10. The medical device according to any one of claims 1 to 7, comprising a supply section that passes through the processing space and is capable of supplying a therapeutic substance to the inflow liquid stored in the liquid storage space.

11. A method of treatment using the medical device according to any one of claims 1 to 7, comprising: an insertion step of inserting the insertion portion into the living body; a suction treatment step of suctioning the body fluid from the living body as the inflow liquid through the liquid flow path and passing the body fluid through the treatment space to treat the body fluid; an injection step of injecting the body fluid that has passed through the treatment space and been stored in the liquid storage space as the outflow liquid into the living body through the treatment space and the liquid flow path.

Images