Drug solution administration device

Abstract

This drug solution administration device (1) comprises: a body fluid collection unit (2) capable of collecting body fluid (BF) from a subject (PA); a drug solution discharge unit (3) capable of discharging a drug solution (LM) into the subject (PA); a liquid accommodation part (4) having a body fluid accommodation chamber (41) and a drug solution accommodation chamber (42); a body fluid flow path part (6) for connecting the body fluid collection unit (2) and the body fluid accommodation chamber (41); and a drug solution flow path part (7) for connecting the drug solution discharge unit (3) and the drug solution accommodation chamber (42). The liquid accommodation part (4) has a connection member (43) that connects the drug solution accommodation chamber (42) and the body fluid accommodation chamber (41) such that the body fluid accommodation chamber (41) expands in order to introduce the body fluid (BF) from the body fluid collection unit (2) toward the body fluid accommodation chamber (41) in accordance with the shrinking of the drug solution accommodation chamber (42) in order to derive the drug solution (LM) from the drug solution accommodation chamber (42) toward the drug solution discharge unit (3).

Description

Drug administration device

[0001] The present invention relates to a drug solution administration device.

[0002] A conventional technique is known in which a body fluid is sampled from a subject and a medicinal liquid is administered to the subject based on the measured value of the sampled body fluid. A blood glucose monitoring control system that employs this technique is disclosed in Patent Document 1.

[0003] The blood glucose monitoring and control system disclosed in Patent Document 1 includes a measuring device attached to a subject and a liquid supplying device. The measuring device collects tissue fluid as a bodily fluid from the subject and stores it in a storage chamber (liquid storage chamber). The liquid supplying device administers insulin as a medicinal liquid stored in the storage chamber (liquid supplying chamber) to the subject.

[0004] In the blood glucose monitoring control system disclosed in Patent Document 1, the measuring device and the liquid supply device, which are attached to the subject, each have a storage chamber. Therefore, each device is relatively large, which may place a burden on the subject when attached to the subject. Furthermore, because the administration of medicinal liquid and the collection of bodily fluid are performed by changing the volumes of the two storage chambers separately, it may not be possible to reliably collect bodily fluid in accordance with the administration of medicinal liquid.

[0005] Japanese Patent Application Laid-Open No. 2019-93125

[0006] An object of the present invention is to provide a medicinal liquid administration device that can reduce the burden on a subject and can reliably collect bodily fluids in response to administration of a medicinal liquid.

[0007] According to one aspect of the present invention, a drug solution administration device is an apparatus for collecting a body fluid from a subject and administering the drug solution to the subject. The drug solution administration device includes a body fluid collection unit capable of collecting the body fluid from the subject, a drug solution discharge unit capable of discharging the drug solution to the subject, a liquid storage unit having a body fluid storage chamber capable of storing the body fluid and a drug solution storage chamber capable of storing the drug solution, a body fluid flow path unit connecting the body fluid collection unit to the body fluid storage chamber to allow the body fluid to flow, and a drug solution flow path unit connecting the drug solution discharge unit to the drug solution storage chamber to allow the drug solution to flow. The liquid storage unit has a connecting member connecting the drug solution storage chamber to the body fluid storage chamber such that the drug solution storage chamber expands to introduce the body fluid from the body fluid collection unit to the body fluid storage chamber in response to the drug solution storage chamber contracting to allow the drug solution to be drawn from the drug solution storage chamber to the drug solution discharge unit.

[0008] According to the present invention, it is possible to provide a medicinal liquid administration device that can reduce the burden on a subject and can reliably collect body fluids in response to administration of a medicinal liquid.

[0009] The objects, features and advantages of the present invention will become more apparent from the following detailed description and the accompanying drawings.

[0010] Fig. 1 is a diagram schematically showing a medicinal liquid administration device according to an embodiment of the present invention; Fig. 2 is a diagram showing a first example of a liquid storage section provided in the medicinal liquid administration device; Fig. 3 is a diagram showing a second example of a liquid storage section provided in the medicinal liquid administration device; Fig. 4 is a flowchart showing a process flow for medicinal liquid discharge and bodily fluid collection in the medicinal liquid administration device; Fig. 5 is a diagram schematically showing a medicinal liquid administration device according to a first modified example; Fig. 6 is a diagram schematically showing a medicinal liquid administration device according to a second modified example; Fig. 7 is a flowchart showing a process flow for medicinal liquid discharge and bodily fluid collection in the medicinal liquid administration device according to the modified examples.

[0011] DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, an embodiment of a drug solution administration device according to the present invention will be described with reference to the drawings.

[0012] FIG. 1 is a schematic diagram illustrating a medicinal solution administration device 1 according to one embodiment of the present invention. FIGS. 2 and 3 are enlarged views of a liquid storage unit 4 provided in the medicinal solution administration device 1. The medicinal solution administration device 1 is an apparatus capable of collecting body fluid BF from a subject PA and administering a medicinal solution LM to the subject PA. The medicinal solution administration device 1 can be applied to, for example, insulin therapy for a subject PA who is a diabetic patient, negative pressure wound therapy for wound treatment, and levodopa-carbidopa enteral therapy for a subject PA who is a Parkinson's disease patient. In the following description, a medicinal solution administration device 1 applied to insulin therapy will be exemplified.

[0013] A medicinal solution administration device 1 applied to insulin therapy collects tissue fluid or blood filling between subcutaneous cells of a subject PA as body fluid BF, and administers insulin as medicinal solution LM to the subject PA. The medicinal solution administration device 1 includes a body fluid collection unit 2, a medicinal solution discharge unit 3, a liquid storage unit 4, a fluid delivery pump 5, a body fluid flow path unit 6, and a medicinal solution flow path unit 7.

[0014] The body fluid sampling unit 2 is attached to the skin of the subject PA and is configured to be able to sample body fluid BF from the subject PA. The body fluid sampling unit 2 is a hollow member having a body fluid sampling hole 21 that contacts the subject PA when attached to the subject PA, and a body fluid outlet 22 that does not contact the subject PA. The body fluid sampling hole 21 includes, for example, a needle having a body fluid sampling hole that allows the flow of body fluid BF. The body fluid sampling unit 2 samples body fluid BF from the subject PA through the body fluid sampling hole 21 and takes it inside. The body fluid outlet 22 is an opening through which the body fluid BF sampled from the subject PA flows out of the body fluid sampling unit 2.

[0015] The medicinal solution discharger 3 is attached to the skin of the subject PA and is configured to be able to discharge the medicinal solution LM into the subject PA. The medicinal solution discharger 3 is a hollow member having a medicinal solution discharge hole 31 that contacts the subject PA when attached to the subject PA, and a medicinal solution inlet 32 ​​that does not contact the subject PA. The medicinal solution discharge hole 31 includes, for example, a needle having a medicinal solution discharge hole that allows the medicinal solution LM to flow through. The medicinal solution discharger 3 discharges the medicinal solution LM into the subject PA through the medicinal solution discharge hole 31. This allows the medicinal solution LM to be administered to the subject PA. The medicinal solution inlet 32 ​​is an opening through which the medicinal solution LM flows into the medicinal solution discharger 3 from outside.

[0016] The liquid storage unit 4 is a hollow member having an internal chamber forming portion 40 that forms an internal chamber. The liquid storage unit 4 has a body fluid storage chamber 41 capable of storing body fluid BF and a medicinal liquid storage chamber 42 capable of storing medicinal liquid LM as storage chambers that constitute the internal chamber of the internal chamber forming portion 40. The medicinal liquid storage chamber 42 is pre-stored with a predetermined amount of medicinal liquid LM. In this embodiment, the liquid storage unit 4 has a connecting member 43 that divides the internal chamber of the internal chamber forming portion 40 into the body fluid storage chamber 41 and the medicinal liquid storage chamber 42, a body fluid inlet 411 that communicates with the body fluid storage chamber 41, and a medicinal liquid outlet 421 that communicates with the medicinal liquid storage chamber 42. The body fluid inlet 411 is an opening formed in the internal chamber forming portion 40 through which the body fluid BF is introduced into the body fluid storage chamber 41 from outside. The liquid medicine outlet 421 is an opening formed in the internal chamber forming portion 40 and is an opening through which the liquid medicine LM in the liquid medicine storage chamber 42 is discharged to the outside of the liquid medicine storage chamber 42 .

[0017] Connecting member 43 is provided inside internal chamber forming portion 40 and connects bodily fluid storage chamber 41 and medicinal solution storage chamber 42. In the present embodiment, connecting member 43 forms a partition wall separating bodily fluid storage chamber 41 and medicinal solution storage chamber 42. Connecting member 43 may be made of a flexible material as shown in Figure 2, or may be made of a rigid material as shown in Figure 3.

[0018] In the liquid storage unit 4, the bodily fluid storage chamber 41 is connected to the bodily fluid sampling unit 2 by a bodily fluid flow path unit 6, and the medicinal liquid storage chamber 42 is connected to the medicinal liquid discharge unit 3 by a medicinal liquid flow path unit 7. The bodily fluid flow path unit 6 is a member that connects the bodily fluid storage chamber 41 and the bodily fluid sampling unit 2 to allow the flow of the bodily fluid BF. Specifically, the bodily fluid flow path unit 6 connects the bodily fluid storage chamber 41 and the bodily fluid sampling unit 2 so that the bodily fluid inlet 411 of the bodily fluid storage chamber 41 communicates with the bodily fluid outlet 22 of the bodily fluid sampling unit 2, thereby forming a flow path through which the bodily fluid BF flows. The bodily fluid BF that flows out of the bodily fluid sampling unit 2 through the bodily fluid outlet 22 flows through the bodily fluid flow path unit 6 and is introduced into the bodily fluid storage chamber 41 through the bodily fluid inlet 411. The medicinal liquid flow path unit 7 is a member that connects the medicinal liquid storage chamber 42 and the medicinal liquid discharge unit 3 to allow the flow of the medicinal liquid LM. Specifically, the liquid medicine flow path section 7 connects the liquid medicine storage chamber 42 and the liquid medicine discharge section 3 so that the liquid medicine outlet 421 of the liquid medicine storage chamber 42 communicates with the liquid medicine inlet 32 ​​of the liquid medicine discharge section 3, thereby forming a flow path through which the liquid medicine LM flows. The liquid medicine LM discharged from the liquid medicine storage chamber 42 through the liquid medicine outlet 421 flows through the liquid medicine flow path section 7 and enters the liquid medicine discharge section 3 through the liquid medicine inlet 32. The body fluid flow path section 6 and the liquid medicine flow path section 7 are formed, for example, from tube members.

[0019] In the liquid storage section 4, the connecting member 43 connects the drug liquid storage chamber 42 and the body fluid storage chamber 41 so that as the drug liquid storage chamber 42 shrinks to extract the drug liquid LM from the drug liquid storage chamber 42 toward the drug liquid discharge section 3, the body fluid storage chamber 41 expands to introduce the body fluid BF from the body fluid collection section 2 toward the body fluid storage chamber 41.

[0020] That is, in the medicinal liquid administration device 1, as the volume of the medicinal liquid storage chamber 42 in the liquid storage unit 4 decreases, pressure is applied to the medicinal liquid LM in the medicinal liquid storage chamber 42, causing the medicinal liquid LM to be discharged from the medicinal liquid storage chamber 42 to the medicinal liquid discharge unit 3 through the medicinal liquid flow path 7. Furthermore, as the volume of the bodily fluid storage chamber 41 in the liquid storage unit 4 increases, the pressure in the bodily fluid storage chamber 41 decreases, causing the bodily fluid BF to be introduced from the bodily fluid collection unit 2 into the bodily fluid storage chamber 41 through the bodily fluid flow path 6. In this way, with the bodily fluid collection unit 2 and the medicinal liquid discharge unit 3 each attached to the subject PA, it is possible to administer the medicinal liquid LM discharged from the medicinal liquid discharge unit 3 to the subject PA, and it is also possible to collect the bodily fluid BF from the subject PA through the bodily fluid collection unit 2.

[0021] Furthermore, in the medicinal solution administration device 1, the medicinal solution storage chamber 42 for delivering the medicinal solution LM to the medicinal solution discharge unit 3 and the bodily fluid storage chamber 41 for introducing the bodily fluid BF from the bodily fluid collection unit 2 are connected by a connecting member 43 and are integrated into a single liquid storage unit 4. This makes it possible to reduce the size of the bodily fluid collection unit 2 and the medicinal solution discharge unit 3 attached to the subject PA, as well as the overall size of the medicinal solution administration device 1, compared to a structure in which separate storage chambers are provided for the bodily fluid collection unit 2 and the medicinal solution discharge unit 3. This makes it possible to reduce the burden on the subject PA when the bodily fluid collection unit 2 and the medicinal solution discharge unit 3 are attached to the subject PA. Moreover, in the liquid storage section 4, the liquid medicinal solution storage chamber 42 and the bodily fluid storage chamber 41 are connected by the connecting member 43 so that the bodily fluid storage chamber 41 expands in response to the contraction of the liquid medicinal solution storage chamber 42, so that the liquid medicinal solution LM can be drawn out from the liquid medicinal solution storage chamber 42 to the liquid medicinal solution discharge section 3 as the liquid medicinal solution storage chamber 42 contracts, and the bodily fluid BF can be introduced from the bodily fluid collection section 2 to the bodily fluid storage chamber 41 as the bodily fluid storage chamber 41 expands. This makes it possible to reliably collect the bodily fluid BF from the subject PA through the bodily fluid collection section 2 in response to the administration of the liquid medicinal solution LM discharged from the liquid medicinal solution discharge section 3 to the subject PA.

[0022] In this embodiment, the medicinal solution administration device 1 includes a liquid delivery pump 5. The liquid delivery pump 5 is an example of a force applying mechanism that applies force to the connecting member 43 so that the body fluid storage chamber 41 expands in response to the contraction of the medicinal solution storage chamber 42. Examples of the liquid delivery pump 5 include a micropump such as a diaphragm pump, a peristaltic pump, and the like.

[0023] The liquid supply pump 5 is connected to at least one of the liquid medicine flow path section 7 and the body fluid flow path section 6. The liquid supply pump 5 applies pressure to at least one of the first fluid (liquid medicine LM) located between the liquid medicine storage chamber 42 and the liquid medicine discharge section 3 and the second fluid (body fluid BF, gas) located between the body fluid collection section 2 and the body fluid storage chamber 41 so that at least one of the fluids moves in a predetermined direction, thereby applying a force to the connecting member 43 to move the pressurized fluid.

[0024] Specifically, when the liquid feed pump 5 is connected to the liquid medicine flow path section 7, the liquid feed pump 5 applies pressure to the first fluid located between the liquid medicine storage chamber 42 and the liquid medicine discharge section 3 so that the first fluid moves in a direction from the liquid medicine storage chamber 42 toward the liquid medicine discharge section 3. In this case, the liquid feed pump 5 can apply a force that moves the pressurized first fluid to the connecting member 43. As a result, in the liquid storage section 4, the liquid medicine storage chamber 42 contracts and the body fluid storage chamber 41 expands.

[0025] When the liquid feed pump 5 is connected to the bodily fluid flow path section 6, the liquid feed pump 5 applies pressure to the second fluid located between the bodily fluid sampling section 2 and the bodily fluid storage chamber 41 so that the second fluid moves in a direction from the bodily fluid sampling section 2 toward the bodily fluid storage chamber 41. In this case, the liquid feed pump 5 can apply a force that moves the pressurized second fluid to the connecting member 43. As a result, in the liquid storage section 4, the bodily fluid storage chamber 41 expands in response to the contraction of the medicinal solution storage chamber 42.

[0026] When the liquid feed pump 5 is connected individually to both the drug solution flow path section 7 and the body fluid flow path section 6, the liquid feed pump 5 applies pressure to the first fluid located between the drug solution storage chamber 42 and the drug solution discharge section 3 so that the first fluid moves in a direction from the drug solution storage chamber 42 toward the drug solution discharge section 3, and applies pressure to the second fluid located between the body fluid sampling section 2 and the body fluid storage chamber 41 so that the second fluid moves in a direction from the body fluid sampling section 2 toward the body fluid storage chamber 41. In this case, the liquid feed pump 5 can apply a force to the connecting member 43 that moves the pressurized first and second fluids. As a result, in the liquid storage section 4, the drug solution storage chamber 42 contracts and the body fluid storage chamber 41 expands.

[0027] 2, if the connecting member 43 is made of a flexible material, the connecting member 43 is deformed by the fluid movement force exerted by the liquid feed pump 5. This deformation of the connecting member 43 causes the drug solution storage chamber 42 to contract, thereby expanding the body fluid storage chamber 41. On the other hand, as shown in FIG. 3, if the connecting member 43 is made of a rigid material and is movably provided within the internal chamber forming portion 40 of the liquid storage unit 4, the connecting member 43 moves by the fluid movement force exerted by the liquid feed pump 5. This movement of the connecting member 43 causes the drug solution storage chamber 42 to contract, thereby expanding the body fluid storage chamber 41.

[0028] The force applying mechanism that applies force to the connecting member 43 is not limited to the liquid feed pump 5. If the connecting member 43 is made of a flexible material, the force applying mechanism may be, for example, a mechanism including a displacement element such as a piezoelectric element. In this case, the displacement element is attached to the connecting member 43 and applies a force that deforms the connecting member 43. If the connecting member 43 is made of a rigid material, the force applying mechanism may be, for example, a mechanism including a motor that generates a driving force to move the connecting member 43. In this case, the connecting member 43 moves when the driving force of the motor is applied.

[0029] As shown in FIG. 1 , the medicinal solution administration device 1 further includes a sensor 8. The sensor 8 is preferably provided in the body fluid collection unit 2. The sensor 8 is a measurement sensor capable of measuring the amount of a predetermined substance in the body fluid BF collected by the body fluid collection unit 2. In the medicinal solution administration device 1 applied to insulin therapy, the sensor 8 measures a blood glucose level indicating the concentration of glucose, which is a predetermined substance in the body fluid BF. When the body fluid BF is tissue fluid, the sensor 8 converts the concentration of glucose in the tissue fluid into a blood glucose level. When the body fluid BF is blood, the sensor 8 measures the concentration of glucose in the blood directly as a blood glucose level.

[0030] When the medicinal solution administration device 1 is equipped with the sensor 8, it becomes possible to control the protrusion of the medicinal solution LM from the medicinal solution discharge unit 3 based on the measurement value of the sensor 8. Furthermore, since the body fluid collection unit 2 is located at the most upstream position in the flow direction of the body fluid BF, by providing the sensor 8 in the body fluid collection unit 2, the concentration of glucose in the body fluid BF can be measured more reliably than when the sensor 8 is provided in the body fluid flow path unit 6 or the body fluid storage chamber 41.

[0031] Next, a method of using the drug solution administration device 1 when applied to insulin therapy will be described with reference to the flowchart of FIG.

[0032] When using the medicinal solution administration device 1, first, the body fluid collection unit 2 and the medicinal solution discharge unit 3 are attached to the skin of the subject PA. With the body fluid collection unit 2 and the medicinal solution discharge unit 3 attached to the subject PA, the operation of the liquid delivery pump 5 is started (step a1).

[0033] When the liquid feed pump 5 is driven, the connecting member 43 deforms or moves within the internal chamber forming portion 40 of the liquid storage unit 4, causing the medicinal liquid storage chamber 42 to shrink and the body fluid storage chamber 41 to expand. This causes the medicinal liquid LM to move from the medicinal liquid storage chamber 42 to the medicinal liquid discharge unit 3 through the medicinal liquid flow path 7, and the body fluid BF to move from the body fluid sampling unit 2 to the body fluid storage chamber 41 through the body fluid flow path 6. This allows the medicinal liquid LM continuously discharged from the medicinal liquid discharge unit 3 to be continuously administered to the subject PA, and allows the body fluid BF to be continuously sampled from the subject PA through the body fluid sampling unit 2 (step a2). While the body fluid BF is being continuously sampled through the body fluid sampling unit 2, the glucose concentration in the body fluid BF is continuously or intermittently measured by the sensor 8 (step a2).

[0034] While the liquid supply pump 5 is driven to continuously administer the liquid medicine LM to the subject PA and collect the body fluid BF from the subject PA, the liquid medicine storage chamber 42 continues to contract, and the body fluid storage chamber 41 continues to expand. In this state, it is determined whether administration of the liquid medicine LM to the subject PA has been completed (step a3). For example, if the entire amount of the liquid medicine LM contained in the liquid medicine storage chamber 42 has been discharged from the liquid medicine storage chamber 42, administration of the liquid medicine LM to the subject PA has been completed (YES in step a3). In this case, the liquid supply pump 5 is stopped (step a4), the body fluid collection unit 2 and the liquid medicine discharge unit 3 are removed from the subject PA, and use of the liquid medicine administration device 1 is terminated.

[0035] If the administration of the medicinal liquid LM to the subject PA has not been completed while the medicinal liquid LM remains in the medicinal liquid storage chamber 42 (NO in step a3), it is determined whether the measurement value of the sensor 8 has reached a predetermined discharge stop value (step a5). The discharge stop value indicates the blood glucose level of the subject PA at which the discharge of the medicinal liquid LM from the medicinal liquid discharge unit 3 is permitted to be stopped. If the measurement value of the sensor 8 has not reached the discharge stop value (NO in step a5), the discharge of the medicinal liquid LM from the medicinal liquid discharge unit 3 and the collection of the body fluid BF from the body fluid collection unit 2 continue.

[0036] When the measurement value of sensor 8 reaches the discharge stop value (YES in step a5), a discharge restart time indicating the time when discharge of the liquid medicinal fluid LM from the liquid medicinal fluid discharge unit 3 should be resumed is calculated based on the history of the measurement values ​​of sensor 8 (step a6), and then driving of the liquid feed pump 5 is stopped (step a7). When driving of the liquid feed pump 5 is stopped, deformation or movement of the connecting member 43 within the internal chamber forming portion 40 of the liquid storage unit 4 stops, thereby stopping changes in the volumes of the liquid medicinal fluid storage chamber 42 and the body fluid storage chamber 41. This stops discharge of the liquid medicinal fluid LM from the liquid medicinal fluid discharge unit 3 and collection of the body fluid BF from the body fluid collection unit 2. In this state, it is determined whether the discharge stop time, indicating the time during which discharge of the liquid medicinal fluid LM from the liquid medicinal fluid discharge unit 3 has been stopped, has reached the discharge restart time (step a8). When the discharge stop time has reached the discharge restart time (YES in step a8), the process returns to step a1 and driving of the liquid feed pump 5 is started.

[0037] 5 is a diagram schematically illustrating a chemical liquid administration device 1A according to a first modified example. The chemical liquid administration device 1A has the same configuration as the above-described chemical liquid administration device 1, except that it includes a chemical liquid discharge flow path 91A and a backup pump 92A.

[0038] The chemical liquid discharge flow path 91A is connected to the chemical liquid storage chamber 42 separately from the chemical liquid flow path 7, and is a member that forms a flow path for discharging the chemical liquid LM from the chemical liquid storage chamber 42 to the outside. The spare pump 92A is connected to the chemical liquid discharge flow path 91A, and is a pump that discharges the chemical liquid LM from the chemical liquid storage chamber 42 to the outside through the chemical liquid discharge flow path 91A.

[0039] The backup pump 92A is driven when the discharge of the medicinal liquid LM from the medicinal liquid discharge portion 3 is stopped. When the backup pump 92A is driven, the drive of the liquid feed pump 5 is stopped. When the backup pump 92A is driven and the drive of the liquid feed pump 5 is stopped, the connecting member 43 deforms or moves within the internal chamber forming portion 40 of the liquid storage portion 4, causing the medicinal liquid storage chamber 42 to shrink and the body fluid storage chamber 41 to expand. In this case, with the discharge of the medicinal liquid LM from the medicinal liquid storage chamber 42 to the medicinal liquid discharge portion 3 restricted and the discharge of the medicinal liquid LM from the medicinal liquid discharge portion 3 stopped, the medicinal liquid LM is discharged from the medicinal liquid storage chamber 42 to the outside through the medicinal liquid discharge flow path 91A, and the body fluid BF is sent from the body fluid collecting portion 2 to the body fluid storage chamber 41 through the body fluid flow path 6. This makes it possible to collect the body fluid BF from the subject PA through the body fluid collecting section 2 while the discharge of the drug solution LM from the drug solution discharging section 3 is stopped. While the body fluid BF is being collected through the body fluid collecting section 2, the concentration of glucose in the body fluid BF can be measured by the sensor 8.

[0040] 6 is a diagram schematically illustrating a medicinal liquid administration device 1B according to a second modified example. The medicinal liquid administration device 1B has the same configuration as the above-described medicinal liquid administration device 1, except that it includes a bodily fluid discharge flow path portion 91B and a spare pump 92B.

[0041] The bodily fluid discharge flow path 91B is a flow path branched off from the bodily fluid flow path 6, and is a component that forms a flow path for discharging the bodily fluid BF in the bodily fluid flow path 6 to the outside. The spare pump 92B is connected to the bodily fluid discharge flow path 91B, and is a pump for discharging the bodily fluid BF in the bodily fluid flow path 6 to the outside through the bodily fluid discharge flow path 91B.

[0042] The backup pump 92B is driven when the discharge of the medicinal liquid LM from the medicinal liquid discharge unit 3 is stopped. When the backup pump 92B is driven, the drive of the liquid feed pump 5 is stopped. When the drive of the liquid feed pump 5 is stopped, the deformation or movement of the connecting member 43 within the internal chamber forming portion 40 of the liquid storage unit 4 is stopped, and the volumetric changes of the medicinal liquid storage chamber 42 and the body fluid storage chamber 41 are stopped. In this case, the discharge of the medicinal liquid LM from the medicinal liquid storage chamber 42 to the medicinal liquid discharge unit 3 is restricted, and the discharge of the medicinal liquid LM from the medicinal liquid discharge unit 3 is stopped. On the other hand, when the backup pump 92B is driven, the body fluid BF is sent from the body fluid collection unit 2 through the body fluid flow path 6 and the body fluid discharge flow path 91B and discharged to the outside. This makes it possible to collect the body fluid BF from the subject PA through the body fluid collection unit 2 when the discharge of the medicinal liquid LM from the medicinal liquid discharge unit 3 is stopped. While the body fluid BF is being collected through the body fluid collection section 2, the concentration of glucose in the body fluid BF can be measured by the sensor 8.

[0043] Next, a method of using the chemical solution administration devices 1A and 1B according to the first and second modifications will be described with reference to the flowchart of FIG.

[0044] When using the medicinal solution administration devices 1A and 1B, the body fluid collection unit 2 and the medicinal solution discharge unit 3 are first attached to the skin of the subject PA, as in the case of the above-described medicinal solution administration device 1. With the body fluid collection unit 2 and the medicinal solution discharge unit 3 attached to the subject PA, the operation of the fluid delivery pump 5 is started (step b1). In this case, the operation of the backup pumps 92A and 92B is stopped.

[0045] When the liquid feed pump 5 is driven, the connecting member 43 deforms or moves within the internal chamber forming portion 40 of the liquid storage unit 4, causing the medicinal liquid storage chamber 42 to shrink and the bodily fluid storage chamber 41 to expand. As a result, the medicinal liquid LM moves from the medicinal liquid storage chamber 42 to the medicinal liquid discharge unit 3 through the medicinal liquid flow path 7, and the bodily fluid BF moves from the bodily fluid sampling unit 2 to the bodily fluid storage chamber 41 through the bodily fluid flow path 6. This makes it possible to administer the medicinal liquid LM discharged from the medicinal liquid discharge unit 3 to the subject PA, and to sample the bodily fluid BF from the subject PA through the bodily fluid sampling unit 2 (step b2). While the bodily fluid BF is being sampled through the bodily fluid sampling unit 2, the glucose concentration in the bodily fluid BF is measured by the sensor 8 (step b2).

[0046] It is determined whether or not the administration of the medicinal liquid LM to the subject PA has been completed (step b3) while the administration of the medicinal liquid LM to the subject PA and the collection of the body fluid BF from the subject PA are continuously performed in accordance with the operation of the liquid supply pump 5. When the entire amount of the medicinal liquid LM contained in the medicinal liquid storage chamber 42 has been discharged from the medicinal liquid storage chamber 42 and the administration of the medicinal liquid LM to the subject PA has been completed (YES in step b3), the operation of the liquid supply pump 5 is stopped (step b4), the body fluid collection unit 2 and the medicinal liquid discharge unit 3 are detached from the subject PA, and the use of the medicinal liquid administration device 1A, 1B is terminated.

[0047] If the administration of the liquid medicinal substance LM to the subject PA has not been completed while the liquid medicinal substance LM remains in the liquid medicinal substance storage chamber 42 (NO in step b3), it is determined whether the measurement value of the sensor 8 has reached a predetermined discharge stop value (step b5). If the measurement value of the sensor 8 has not reached the discharge stop value (NO in step b5), the discharge of the liquid medicinal substance LM from the liquid medicinal substance discharge unit 3 and the collection of the body fluid BF from the body fluid collection unit 2 continue.

[0048] When the measurement value of the sensor 8 reaches the discharge stop value (YES in step b5), the backup pumps 92A and 92B are driven (step b6), and the driving of the liquid supply pump 5 is stopped (step b7). This stops the discharge of the liquid medicinal product LM from the liquid medicinal product discharge unit 3, while continuing the collection of the body fluid BF from the subject PA through the body fluid collection unit 2. While the body fluid BF is being collected through the body fluid collection unit 2, the concentration of glucose in the body fluid BF is measured by the sensor 8.

[0049] In this case, it is determined whether the measurement value of the sensor 8 has reached a predetermined discharge restart value (step b8). The discharge restart value indicates the blood glucose level of the subject PA at which the resumption of discharge of the liquid medicinal product LM from the liquid medicinal product discharge unit 3 is permitted. If the measurement value of the sensor 8 has reached the discharge restart value (YES in step b8), the operation of the backup pumps 92A and 92B is stopped (step b9), and the process returns to step b1, where the operation of the liquid feed pump 5 is started.

[0050] Although the embodiment of the present invention has been described above, the present invention is not limited to this and may take the following modified embodiments, for example.

[0051] In the above embodiment, the medicinal solution administration device 1 is described as being applicable to insulin therapy. However, the present invention is not limited to this. The medicinal solution administration device 1 may also be applied to negative pressure wound therapy for wound treatment. In this case, the medicinal solution administration device 1 collects exudate from a wound in the subject PA as body fluid BF and administers an antibacterial solution or a cleaning solution to the wound in the subject PA as the medicinal solution LM. Specifically, in the medicinal solution administration device 1, the liquid storage unit 4 reduces the size of the medicinal solution storage chamber 42 to deliver the antibacterial solution or cleaning solution (medicinal solution LM) from the medicinal solution storage chamber 42 through the medicinal solution flow path 7 toward the medicinal solution discharge unit 3, and expands the body fluid storage chamber 41 to introduce the exudate (medicinal fluid BF) from the body fluid collection unit 2 to the body fluid storage chamber 41 through the body fluid flow path 6. This allows the antibacterial solution or cleaning solution (medicinal solution LM) discharged from the medicinal solution discharge unit 3 to be administered to the wound in the subject PA, and allows the exudate (medicinal fluid BF) to be collected from the subject PA through the body fluid collection unit 2. The sensor 8 measures the concentration of hydrogen ions as a predetermined substance in the exudate, which is the body fluid BF.

[0052] The medicinal solution administration device 1 may also be applied to levodopa-carbidopa enteral therapy, which is an example of clinical therapy for Parkinson's disease. In levodopa-carbidopa enteral therapy, a tube is inserted through a gastrostomy created in the stomach of the subject PA, and the tip of the tube is fixed to the upper part of the small intestine. Then, a levodopa-carbidopa hydrate enteral liquid (LCIG) as the medicinal solution LM is administered to the subject PA through the tube. In this case, the medicinal solution administration device 1 collects blood as body fluid BF from the subject PA and administers LCIG as the medicinal solution LM through a tube inserted into the gastrostomy created in the subject PA. Specifically, in the medicinal solution administration device 1, the liquid storage unit 4 draws out LCIG, which is the medicinal solution LM, from the medicinal solution storage chamber 42 toward the medicinal solution discharge unit 3 through the medicinal solution flow path unit 7 by reducing the size of the medicinal solution storage chamber 42, and introduces blood, which is the bodily fluid BF, from the bodily fluid collection unit 2 through the bodily fluid flow path unit 6 into the bodily fluid storage chamber 41 by expanding the bodily fluid storage chamber 41. This makes it possible to administer LCIG, which is the medicinal solution LM discharged from the medicinal solution discharge unit 3, to the subject PA through a tube, and to collect blood, which is the bodily fluid BF, from the subject PA through the bodily fluid collection unit 2. The sensor 8 measures the concentration of LCIG, which is a predetermined substance, in blood, which is the bodily fluid BF.

[0053] In the above embodiment, the liquid storage unit 4 has been described as having a connecting member 43 that forms a partition wall separating the bodily fluid storage chamber 41 and the medicinal fluid storage chamber 42. However, the present invention is not limited to this. The liquid storage unit 4 may have a first bellows portion configured in an expandable and contractible bellows shape to form the bodily fluid storage chamber 41, a second bellows portion configured in an expandable and contractible bellows shape to form the medicinal fluid storage chamber 42, and a connecting member 43 that connects the bottoms of the first and second bellows portions together. In this case, the connecting member 43 connects the bottoms of the first and second bellows portions together so that the bodily fluid storage chamber 41 expands as the first bellows portion expands in response to the contraction of the second bellows portion, thereby reducing the medicinal fluid storage chamber 42.

[0054] The above-described specific embodiments mainly include inventions having the following configurations.

[0055] According to one aspect of the present invention, a drug solution administration device is an apparatus for collecting a body fluid from a subject and administering the drug solution to the subject. The drug solution administration device includes a body fluid collection unit capable of collecting the body fluid from the subject, a drug solution discharge unit capable of discharging the drug solution to the subject, a liquid storage unit having a body fluid storage chamber capable of storing the body fluid and a drug solution storage chamber capable of storing the drug solution, a body fluid flow path unit connecting the body fluid collection unit to the body fluid storage chamber to allow the body fluid to flow, and a drug solution flow path unit connecting the drug solution discharge unit to the drug solution storage chamber to allow the drug solution to flow. The liquid storage unit has a connecting member connecting the drug solution storage chamber to the body fluid storage chamber such that the drug solution storage chamber expands to introduce the body fluid from the body fluid collection unit to the body fluid storage chamber in response to the drug solution storage chamber contracting to allow the drug solution to be drawn from the drug solution storage chamber to the drug solution discharge unit.

[0056] With this drug solution administration device, pressure is applied to the drug solution in the drug solution storage chamber in response to a reduction in the volume of the drug solution storage chamber in the liquid storage unit, causing the drug solution to be discharged from the drug solution storage chamber through the drug solution flow path to the drug solution discharge unit. Furthermore, pressure in the bodily fluid storage chamber decreases in response to an expansion in the volume of the bodily fluid storage chamber in the liquid storage unit, causing bodily fluid to be introduced from the bodily fluid collection unit through the bodily fluid flow path to the bodily fluid storage chamber. This makes it possible, with the bodily fluid collection unit and the drug solution discharge unit both attached to the subject, to administer the drug solution discharged from the drug solution discharge unit to the subject, and to collect bodily fluid from the subject through the bodily fluid collection unit.

[0057] In this drug solution administration device, a drug solution storage chamber for delivering the drug solution to the drug solution discharge portion and a body fluid storage chamber for introducing the body fluid from the body fluid collection portion are integrated into a single liquid storage portion, connected by a connecting member. This allows for a reduction in the size of the body fluid collection portion and the drug solution discharge portion to be attached to the subject, as well as a reduction in the overall size of the drug solution administration device, compared to a structure in which separate storage chambers are provided for the body fluid collection portion and the drug solution discharge portion. This reduces the burden on the subject when the body fluid collection portion and the drug solution discharge portion are attached to the subject. Furthermore, in the liquid storage portion, the drug solution storage chamber and the body fluid storage chamber are connected by a connecting member so that the body fluid storage chamber expands in response to a reduction in the size of the drug solution storage chamber. This allows for simultaneous delivery of the drug solution from the drug solution storage chamber to the drug solution discharge portion due to the reduction in the drug solution storage chamber and introduction of the body fluid from the body fluid collection portion to the body fluid storage chamber due to the expansion of the body fluid storage chamber. This makes it possible to reliably collect body fluid from the subject through the body fluid collecting section in response to administration of the drug solution ejected from the drug solution ejecting section to the subject.

[0058] In the above-described medicinal solution administration device, the connecting member may form a partition wall separating the bodily fluid storage chamber from the medicinal solution storage chamber, and the medicinal solution administration device may further include a force applying mechanism that applies a force to the connecting member so that the bodily fluid storage chamber expands in response to contraction of the medicinal solution storage chamber.

[0059] In this aspect, the force exerted by the force exerting mechanism on the connecting member that constitutes the partition wall of the liquid storage unit causes the medicinal liquid storage chamber to contract and the bodily fluid storage chamber to expand, thereby enabling the medicinal liquid to be simultaneously drawn out from the medicinal liquid storage chamber to the medicinal liquid discharge unit and the bodily fluid to be introduced from the bodily fluid collection unit into the bodily fluid storage chamber in response to the force exerted by the force exerting mechanism on the connecting member.

[0060] In the above-described medicinal solution administration device, the connecting member may be made of a flexible material that is deformed by the force applied by the force application mechanism.

[0061] In this aspect, the connecting member is deformed by the force applied by the force application mechanism, and the body fluid storage chamber expands in response to the contraction of the drug solution storage chamber.

[0062] In the above-mentioned medicinal liquid administration device, the liquid storage section has an internal chamber forming section that forms an internal chamber, and the connecting member divides the internal chamber into the medicinal liquid storage chamber and the body fluid storage chamber, and may be arranged to be movable within the internal chamber forming section by the force applied from the force application mechanism.

[0063] In this aspect, the connecting member is moved by the force applied by the force application mechanism, and the body fluid storage chamber expands in response to the contraction of the drug solution storage chamber.

[0064] In the above-mentioned drug solution administration device, the force-applying mechanism may be configured to apply pressure to at least one of the fluids located between the drug solution storage chamber and the drug solution discharge section and the fluid located between the body fluid collection section and the body fluid storage chamber so that the fluid moves in a predetermined direction, thereby applying a force to the connecting member that causes the pressurized fluid to move.

[0065] In this aspect, the force exerted by the force exerting mechanism to move the fluid is applied to the connecting member, so that the body fluid containing chamber expands in response to the contraction of the drug solution containing chamber.

[0066] The drug solution administration device may further include a sensor that measures the amount of a predetermined substance in the body fluid collected by the body fluid collection section.

[0067] In the above-described drug solution administration device, the sensor may be provided in the body fluid collection section.

[0068] In this embodiment, the sensor can measure the amount of a predetermined substance in the body fluid collected from the subject through the body fluid collecting unit. In this case, for example, it is possible to control the protrusion of the drug solution from the drug solution discharging unit based on the measurement value of the sensor. Furthermore, since the body fluid collecting unit is located at the most upstream position in the direction of flow of the body fluid, by providing the sensor in the body fluid collecting unit, the amount of the substance in the body fluid can be measured more reliably than when a sensor is provided in the body fluid flow path unit or the body fluid storage chamber.

[0069] As described above, the present invention can provide a medicinal liquid administration device that can reduce the burden on a subject and reliably collect bodily fluids in response to administration of medicinal liquid.

Claims

1. A drug liquid administration device for collecting body fluid from a subject and administering a drug liquid to the subject, comprising: a body fluid collection section capable of collecting the body fluid from the subject; a drug liquid discharge section capable of discharging the drug liquid into the subject; a liquid storage section having a body fluid storage chamber capable of storing the body fluid and a drug liquid storage chamber capable of storing the drug liquid; a body fluid flow path section connecting the body fluid collection section to the body fluid storage chamber to flow the body fluid; and a drug liquid flow path section connecting the drug liquid discharge section to the drug liquid storage chamber to flow the drug liquid, wherein the liquid storage section has a connecting member connecting the drug liquid storage chamber to the body fluid storage chamber such that the body fluid storage chamber expands to introduce the body fluid from the body fluid collection section toward the body fluid storage chamber in response to the drug liquid storage chamber shrinking to extract the drug liquid from the drug liquid storage chamber toward the drug liquid discharge section.

2. The drug solution administration device of claim 1, further comprising a force applying mechanism that applies a force to the connecting member so that the bodily fluid storage chamber expands in response to the drug solution storage chamber contracting, and wherein the connecting member forms a partition that separates the bodily fluid storage chamber from the drug solution storage chamber.

3. The drug solution administration device according to claim 2, wherein the connecting member is made of a material having flexibility such that it can be deformed by the force applied by the force application mechanism.

4. A drug solution administration device as described in claim 2, wherein the liquid storage section has an internal chamber forming section which forms an internal chamber, and the connecting member divides the internal chamber into the drug solution storage chamber and the body fluid storage chamber, and is arranged to be movable within the internal chamber forming section by the force applied from the force application mechanism.

5. The drug solution administration device of claim 2, wherein the force imparting mechanism applies pressure to at least one of the fluids located between the drug solution storage chamber and the drug solution discharge section and the fluid located between the bodily fluid collection section and the bodily fluid storage chamber so that the fluid moves in a predetermined direction, thereby imparting a force to the connecting member that causes the pressurized fluid to move.

6. A drug solution administration device as described in any one of claims 1 to 5, further comprising a sensor for measuring the amount of a predetermined substance in the body fluid collected by the body fluid collection section.

7. The drug solution administration device according to claim 6, wherein the sensor is provided in the body fluid collection section.

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