Infusion device

Abstract

Provided is an infusion device 1 for continuously feeding a drug solution. The infusion device 1 is provided with a port 7 for allowing the drug solution to flow into and out of a balloon 6 housed in a bag 5. The port 7 has: a rod part 28 extending from a support part 26S supporting the balloon 6 to the inside of the balloon 6; a connection part 26C provided with an inflow port and an outflow port of the drug solution; and a cover part 25 fitted to the connection part 26C. The rod part 28 is housed in a body part 15 together with the balloon 6 through a neck part 16 of the bag 5, and the port 7 is attached to the bag 5 by fitting the cover part 25 to the connection part 26C with the neck part 16 interposing therebetween.

Description

infusion equipment

[0001] The disclosed technology relates to an infusion device suitable for administering physiological saline solution, etc.

[0002] Patent document 1 discloses an infusion system that uses an expanding foam to pressurize an infusion bag to administer saline solution contained in the infusion bag, thereby enabling continuous delivery of the solution.

[0003] In the above-mentioned infusion system, the infusion bag and the foam are arranged so that their combined volume remains substantially constant before and after infusion, enabling infusion at a constant flow rate. However, the expansion of the foam is easily affected by external factors such as temperature. Therefore, there are issues with reproducibility, making it difficult to put into practical use.

[0004] The disclosed technology involves a known device (infuser) that fills a reversibly elastically deformable bag member (balloon) with a medicinal solution and continuously delivers the solution using the balloon's contraction force. Infusers are highly portable and can stably administer minute amounts of medicinal solution over long periods of time, making them widely used in the medical field, such as chemotherapy.

[0005] In general, infusers are often a type in which a balloon is housed in a hard case the size of a mini bottle. The balloon is filled with the drug solution through a liquid inlet port in the hard case. This inflates the balloon, storing the drug solution under pressure inside the balloon.

[0006] A liquid delivery tube with a connector at the end that can be connected to a winged needle or the like is connected to the liquid outlet of the port. The middle part of the liquid delivery tube is equipped with a flow rate control unit, a filtration filter, a clamp, etc. The medicinal liquid stored in the balloon is delivered at a constant flow rate through the liquid delivery tube by removing the clamp and adjusting the flow rate control unit.

[0007] An example of this type of infuser is disclosed in Patent Document 2. In this infuser, the case for housing the balloon is constructed by fitting a lid, which has a V-shaped branched port for the liquid inlet and outlet, to a cylindrical body with a concave-convex fit. The lid is formed with an air vent for discharging air from inside the case.

[0008] JP-A-2004-73230 JP-A-8-196628

[0009] The administration of saline is an effective treatment for patients with dehydration, especially in severe cases.

[0010] Intravenous drip is a common method for administering saline. However, because intravenous drip utilizes gravity to deliver saline from an infusion bag suspended at a specified height, the treatment location is limited and the patient has difficulty moving. It also requires equipment such as a hanging table. Therefore, intravenous drip has the disadvantage of being less portable and convenient.

[0011] In contrast, if an infuser is used to administer saline, the flow rate can be precisely adjusted, the treatment can be performed anywhere, the patient can move around easily, and no large-scale equipment is required. Therefore, it is highly portable and convenient.

[0012] However, compared to the administration of chemicals such as chemotherapy, the administration of saline does not require high flow rate accuracy, but does require the administration of large amounts. Therefore, there was a lack of accuracy in using conventional infusers for administering saline, and there was room for improvement.

[0013] Therefore, this specification discloses a technique relating to an infusion device suitable for administering a large amount of medicinal liquid.

[0014] The disclosed technology relates to an infusion device for continuously delivering a medicinal solution.

[0015] The infusion device includes a reversibly elastically deformable balloon that contains the medicinal solution and has an opening, a port that allows the medicinal solution to flow in and out of the balloon, and a bag that contains the balloon.

[0016] The port has a support portion that supports the opening portion of the balloon, a rod portion that extends from the support portion to the inside of the balloon, a connect portion that has a cross-sectional area in an axial direction perpendicular to the central axis of the rod portion that is larger than that of the support portion and has an inlet and outlet for the drug solution, and a cover portion that is fitted onto the connect portion from the outside.

[0017] The bag has a bag-shaped body and a neck provided at one end of the body to cover the connect portion. The port is attached to the bag by accommodating the rod together with the balloon in the body through the neck and fitting the cover to the connect portion with the neck interposed therebetween.

[0018] That is, with this infusion device, like conventional infusers, the medicinal solution is contained in a balloon, allowing for continuous administration of the medicinal solution and offering excellent portability and convenience. Because the balloon is contained in a soft, pouch-like bag rather than a hard case, even if the device has a large capacity, it can be made compact for transportation and disposal, making it easy to handle.

[0019] Furthermore, because the port is attached to the bag by fitting the cover to the connector of the port with the neck of the bag interposed between the two, there is a high degree of freedom in combining materials for the bag and port, and even if these materials are different, the port can be securely fixed to the bag, making assembly easy.

[0020] The mating portion consisting of the outer surface of the connecting portion and the inner surface of the cover portion may have an uneven shape on at least one of the outer surface of the connecting portion and the inner surface of the cover portion to sandwich the neck portion.

[0021] This makes it difficult for the port to come loose due to the uneven shape, allowing the bag and port to be more securely fixed.

[0022] At least one of the connecting portion and the cover portion may be formed so that the uneven shape extends in a circumferential direction of the central axis.

[0023] In this way, the direction in which the concave and convex shapes extend is perpendicular to the removal direction, so that the bag and the port can be fixed more securely. The bag may be formed by joining the edge portions of a pair of overlapping synthetic resin sheets together at a predetermined width, excluding the opening in the neck portion.

[0024] This will reduce the bulkiness of the uninflated product.

[0025] The neck portion may be three-dimensionally shaped so as to be able to maintain an open state.

[0026] In this way, when assembling the port to the bag, the port and balloon are inserted through the opening in the neck portion, and if the opening is open, they can be easily inserted. Therefore, the assembling workability is excellent.

[0027] The connecting portion may have a flange portion that protrudes in a direction perpendicular to the axis and extends circumferentially around the central axis, and the flange portion may receive an open end of the neck portion and fit with the cover portion.

[0028] This allows the port to be stably positioned in the axial direction relative to the bag and the cover, resulting in excellent assembly workability.

[0029] The connecting portion may have a slope portion that slopes downward toward the support portion at a portion on the support portion side.

[0030] In this way, the sloped portion allows smooth guidance, making it easier to insert the rod portion and balloon through the opening in the neck portion, thereby improving assembly workability.

[0031] A pair of outer vertical grooves extending in the direction of the central axis may be formed facing each other on the inner surface of the cover part that fits into the outer surface of the connect part, so that when the cover part is fitted into the connect part, a pair of joint margins protruding on both sides of the neck part can be accommodated in the outer vertical grooves.

[0032] When the neck part is sandwiched between the connector part and the cover part, the joint margin can get in the way, but it can be accommodated in the outer longitudinal groove, so it does not get in the way. This prevents the neck part from getting caught or damaged, and makes assembly easier.

[0033] A positioning structure may be provided between the connecting portion and the cover portion to fix their relative positions in the circumferential direction of the central axis.

[0034] This prevents the cover portion from being displaced in the circumferential direction relative to the connect portion, and allows the cover portion to be properly positioned simply by fitting it onto the connect portion.

[0035] An inner vertical groove extending in the direction of the central axis may be formed on the outer surface of the connecting portion, and the inner vertical groove may form an air passage that connects the outer area of ​​the balloon inside the bag to the outside world.

[0036] This allows air to be released from the bag, allowing the balloon to be freely inflated until it is restricted by the bag, allowing the prescribed volume of drug solution to be filled.

[0037] The cover may have a hole formed therein through which a strap can be inserted.

[0038] This allows the infusion device to be hung around the patient's neck or shoulder, thereby improving portability of the infusion device during use.

[0039] The device may further include a tube assembly for transporting the medicinal liquid pushed out from the balloon, the tube assembly having a liquid delivery tube connected to the outlet at one end and having a connector at the other end, and a flow rate setting unit for setting the flow rate of the medicinal liquid being delivered, the flow rate setting unit being configured by an orifice tube provided in a part of the liquid delivery tube and having a specific length and flow path cross section.

[0040] With an orifice tube, a relatively high flow rate can be utilized to set a stable flow rate. Furthermore, because a tube with specific dimensions is used according to the required flow rate, there is no need for a flow control unit with a complex structure like in a conventional infuser. Therefore, the cost and number of parts can be reduced.

[0041] The bag may be constructed from a flexible material.

[0042] This makes it more portable.

[0043] The disclosed technology enables the continuous administration of larger amounts of medicinal liquid than conventional infusers. Therefore, an infusion device incorporating the disclosed technology is suitable for administering saline solution, and is effective in treating dehydration, etc.

[0044] 1 is a schematic perspective view of an infusion device to which the disclosed technology is applied; FIG. 2 is a view for explaining the main parts of a bag; FIG. 3 is a schematic cross-sectional view of the balloon and port portion along arrows A1-A1 in FIG. 1; FIG. 4 is an enlarged view of the main parts of FIG. 3; FIG. 5 is an exploded perspective view of the port; FIG. 6 is a view for explaining the structure of the cover part and the port; FIG. 7 is a schematic cross-sectional view of the fitting portion between the port and the cover part; FIG. 8 is a view for explaining the use of the infusion device; and FIG. 9 is a view for explaining a modified example of the infusion device.

[0045] The disclosed technology will now be described, however, the following description is merely exemplary in nature.

[0046] <Structure of Infusion Device> Figure 1 shows the overall structure of an infusion device 1 to which the disclosed technology is applied. This infusion device 1 is configured to deliver a medicinal liquid continuously, i.e., stably over a long period of time, for infusion (administration of a liquid subcutaneously, intravascularly, intraperitoneally, etc.). In particular, this infusion device 1 is designed to utilize the advantages of conventional infusers, such as portability and convenience, while being capable of administering a large amount of medicinal liquid at a relatively high speed, with a small number of parts, easy assembly, and low cost.

[0047] As mentioned above, saline is an example of a medicinal liquid suitable for the infusion device 1. However, this is not limited to saline, and the infusion device 1 can be used for any medicinal liquid that requires administration in large amounts.

[0048] The infusion device 1 is generally composed of a bag assembly 2 and a tube assembly 3. The bag assembly 2 is composed of components such as a bag 5, a balloon 6, and a port 7. The tube assembly 3 is composed of components such as a liquid delivery tube 8, a clamp 10, and a filter 11.

[0049] 1, the infusion device 1 is manufactured in a state where the bag assembly 2 and the tube assembly 3 are assembled together. Depending on the specifications, the bag assembly 2 and the tube assembly 3 may be manufactured separately.

[0050] The bag assembly 2 is configured to contain a medicinal solution and to push out the medicinal solution by utilizing the pressure generated by the contraction of the balloon 6, as will be described later. The tube assembly 3 is configured to transport the medicinal solution pushed out from the balloon 6.

[0051] (Tube Assembly) The liquid supply tube 8 is made of a silicone tube or the like. The upstream end of the liquid supply tube 8 is connected to the liquid outlet of the port 7. A connector 12 having a locking function and an air vent function is attached to the downstream end of the liquid supply tube 8. When the infusion device 1 is in use, this connector 12 is connected to a winged needle or the like.

[0052] A clamp 10 is attached midway along the liquid supply tube 8. By manual operation, the clamp 10 opens and closes the flow path of the liquid supply tube 8. A filter 11 is installed midway along the flow path of the liquid supply tube 8. Even if foreign matter or bacteria gets mixed into the liquid medicine, they are removed as the liquid medicine passes through the filter 11.

[0053] A flow rate setting unit that sets the flow rate of the medicinal liquid being delivered is provided downstream of the liquid delivery tube 8. The flow rate setting unit is configured with an orifice tube 13 having a specific length and flow path cross section. That is, the length and flow path cross section are specified in advance through experiments or the like in response to pressure changes in the medicinal liquid that accompany the contraction of the balloon 6 so that the medicinal liquid flows at a predetermined flow rate while satisfying the required accuracy.

[0054] As a result, the orifice tube 13 is set to a specific length and flow passage cross section according to the required flow rate. Because only a tube of a specific dimension is used, a complicated flow control section like that of a conventional infuser is not required. Therefore, the cost of materials and the number of parts can be reduced.

[0055] (Bag) The bag 5 is a soft case that houses the balloon 6. The bag 5 is formed by joining a pair of flexible synthetic resin sheets 14, such as soft polyvinyl chloride (PVC), by heat welding, ultrasonic welding, or the like. Because the bag is soft, it can be deformed into a compact shape by rolling or folding the body portion 15 (described below) when carrying it when it is not filled with medicinal solution or after administering saline solution using the infusion device 1, making it more portable than a rigid bag. In particular, when the infusion device 1 is used with saline solution, the volume of the infusion device 1 itself becomes large because the volume is larger than that used in conventional infusers. In this case, a soft bag is more preferable because it is more portable as described above.

[0056] 1 and 2, the bag 5 has a bag-like body portion 15 having a substantially oval shape and a neck portion 16 provided so as to protrude from one end of the body portion 15. The bag 5 is manufactured, for example, as follows.

[0057] After a pair of synthetic resin sheets 14 are overlapped, they are cut to form the body portion 15 and the neck portion 16. The edges of the cut pair of synthetic resin sheets 14 are then joined together at a predetermined width, except for the portion corresponding to the opening of the neck portion 16. As a result, a joining margin 17 is formed around the outer periphery of the bag 5, extending along the edge.

[0058] Therefore, before the port 7 and balloon 6 are attached, the bag 5 has a pair of overlapping soft synthetic resin sheets 14 in both the body portion 15 and the neck portion 16. Therefore, the bag 5 is made flat except for the portion where the port 7 and balloon 6 are attached, which is advantageous because it does not become bulky during transportation of the infusion device 1 or when it is disposed of after use.

[0059] More preferably, the neck portion 16 of the infusion device 1 may be three-dimensionally formed by vacuum forming or the like so that the opening can be maintained in an open state, as shown in Fig. 2. This allows the rod portion 28 and balloon 6 of the port 7 to be easily inserted into the neck portion 16. This eliminates the need to unfold and open the neck portion 16 to insert the port 7 when the soft synthetic resin sheets 14 are overlapped, resulting in excellent assembly workability.

[0060] A pair of joining margins 17 extending out on both sides of the neck portion 16 are provided with narrow portions 18 by cutting away a portion of the joining margins 17. Specifically, the narrow portions 18 are provided in a predetermined range extending from the open end of the neck portion 16 toward the base end (a range that covers the outer surface of a connecting portion 26C, which will be described later).

[0061] (Balloon, Port) The balloon 6 is a member that contains a medicinal liquid. The port 7 is a member that allows the medicinal liquid to flow in and out of the balloon 6.

[0062] Figure 3 shows a schematic cross-sectional view of the balloon 6 and port 7 taken along the arrows A1-A1 in Figure 1. Figure 4 shows an enlarged view of the main parts of Figure 3 to explain the function of each part. Figure 5 shows an exploded perspective view of the port 7.

[0063] Figure 6 shows the cover part 25 and the port 7. The center figure is a front view of the cover part 25 before assembly, the figure above that is a top view of the cover part 25, and the figure to the right of that is a right side view of the cover part 25. The figure below the front view of the cover part 25 is a top view of the port 7 (the third member 23 and fourth member 24, described below, are omitted). Figure 7 shows a schematic cross-sectional view of the mating portion between the port 7 and the cover part 25.

[0064] 5, the port 7 is composed of a first member 21, a second member 22, a third member 23, a fourth member 24, and a cover portion 25. The first member 21, the second member 22, the third member 23, the fourth member 24, and the cover portion 25 are molded products made of a hard synthetic resin such as polypropylene (PP).

[0065] The first member 21 is a member that constitutes the main body of the port 7, and has a short, cylindrical inner support portion 27, a long, cylindrical rod portion 28 that has a smaller diameter than the inner support portion 27 and extends from one end of the inner support portion 27, and a short, cylindrical fitting portion 29 that has a larger diameter than the inner support portion 27 and is provided at the other end of the inner support portion 27. The central axes J of the inner support portion 27, the rod portion 28, and the fitting portion 29 are all coincident.

[0066] The fitting portion 29, together with the third member 23 and the fourth member 24, constitutes a connecting portion. The inner support portion 27, together with the second member 22, constitutes a supporting portion. In the following description, for convenience, the fitting portion 29 etc. may also be referred to as the "connecting portion 26C," and the inner support portion 27 etc. may also be referred to as the "support portion 26S." Furthermore, the direction of the central axis J is referred to as the "axial direction," a direction perpendicular to the central axis J is referred to as the "axial direction," and directions centered on the central axis J are referred to as the circumferential direction, radial direction, etc.

[0067] An annular flange 30 that protrudes in the axial direction is formed on the portion of the inner support part 27 that faces the fitting part 29. A bulge 31 that bulges slightly radially outward is formed on the portion of the inner support part 27 that faces the rod part 28.

[0068] 3, a vertical liquid flow path 32 is formed inside the inner support part 27 and the rod part 28, extending axially through their centers. The vertical liquid flow path 32 in the rod part 28 is formed with a smaller diameter than the vertical liquid flow path 32 in the inner support part 27. A horizontal liquid flow path 33 is formed at the boundary between the inner support part 27 and the rod part 28, penetrating in a direction perpendicular to the axis and communicating with the vertical liquid flow path 32.

[0069] 3 and 5 , the second member 22 is a member that is assembled to the first member 21 so as to cover the inner support portion 27. The second member 22 has a press-fit frame portion 35 that is fixed by being press-fitted into the flange portion 30, and a cylindrical outer support portion 36 that has an inner diameter slightly larger than the outer diameter of the inner support portion 27.

[0070] The balloon 6 is made of a synthetic resin material such as rubber and is reversibly elastically deformable. As shown in Figures 1 and 3, the balloon 6 in an unloaded state has a tubular shape and is fitted onto the rod portion 28. The opening of the balloon 6 is press-fitted into the inner support portion 27. The second member 22 is then fitted onto the balloon 6.

[0071] Then, by press-fitting the press-fit frame 35 into the flange 30 and assembling the second member 22 to the first member 21, the opening of the balloon 6 is crushed while being sandwiched between the outer support member 36 and the inner support member 27. As a result, the balloon 6 is supported by the inner support member 27 and the outer support member 36 (i.e., the support member 26S) with its opening closed.

[0072] As a result, the rod portion 28 of the port 7 is housed so as to extend from the support portion 26S into the inside of the balloon 6, and the connect portion 26C faces the outside of the balloon 6 from the support portion 26S. The rod portion 28 covered by the balloon 6 is housed in the body portion 15 through the neck portion 16. The tip side of the neck portion 16 covers the outer surface of the connect portion 26C, so that the cover portion 25 is fitted into the connect portion 26C with the neck portion 16 interposed therebetween. In this way, the port 7 is attached to the bag 5.

[0073] Specifically, as shown in Figures 4, 5, and 6, the fitting portion 29 has a circular bottom wall portion 37, a short, tubular housing portion 38 that is open and connected to the bottom wall portion 37, and a short, cylindrical wall portion 40. The cross section of the housing portion 38 is elliptical. A seal ring 41 is attached around the opening of the housing portion 38 in the bottom wall portion 37. The fitting portion 29 is connected to the inner support portion 27 via the housing portion 38.

[0074] A plurality of (three in this embodiment) inner ridges 42 that protrude radially outward and extend circumferentially are formed side by side in the axial direction on the outer surface of the cylindrical wall portion 40. As shown in Figure 7, the maximum outer diameter of the cylindrical wall portion 40 is slightly larger than the inner diameter of the neck portion 16, and the minimum outer diameter of the cylindrical wall portion 40 is slightly smaller than the inner diameter of the neck portion 16. As a result, when the cylindrical wall portion 40 is inserted (press-fitted) into the neck portion 16, the neck portion 16 is in close contact with the cylindrical wall portion 40 and enters the recesses between adjacent inner ridges 42.

[0075] A pair of inner longitudinal grooves 43 extending in the axial direction are also formed on the outer surface of the cylindrical wall portion 40, line-symmetrically with respect to the central axis J. Each inner longitudinal groove 43 is formed to penetrate each inner ridge portion 42. Therefore, even if the neck portion 16 is in close contact with the cylindrical wall portion 40, as shown in Figure 4, the presence of the inner ridge portion 42 ensures that a gap 45 (a ventilation passage, described later) extending in the axial direction is formed inside the neck portion 16.

[0076] An annular flange 46 is provided at the tip of the cylindrical wall 40, projecting from the edge in a direction perpendicular to the axis and extending circumferentially. As shown in Figure 7, the outer diameter of the flange 46 is larger than the inner diameter of the neck 16. Therefore, when the port 7 is inserted into the bag 5, the open end of the neck 16 is received by the flange 46. This allows the port 7 to be positioned appropriately in the axial direction relative to the bag 5.

[0077] The inner longitudinal groove 43 is formed so as to penetrate also the flange portion 46. Therefore, the gap 45 secured by the inner longitudinal groove 43 also passes through the flange portion 46.

[0078] As shown in FIG. 6 , the flange portion 46 is formed with a pair of chord-shaped notches 47 (forming a positioning structure) cut into the flange portion 46 in a direction perpendicular to the inner longitudinal groove 43 when viewed from the axial direction.

[0079] The cross-sectional area of ​​the connect portion 26C taken in the direction perpendicular to the axis is larger than that of the support portion 26S (i.e., the inner support portion 27 to which the second member 22 is attached). Therefore, in order to make it easier to insert the connect portion 26C into the neck portion 16, an inclined portion 48 (slope portion) that slopes downward toward the support portion 26S side is formed on the support portion 26S side of the connect portion 26C, as shown in Figures 5 and 7.

[0080] The third member 23 is a member that is assembled to the first member 21 from the side of the fitting portion 29. As shown in Figures 4 and 5 , the third member 23 has a base portion 50 that is fitted into the accommodating cylindrical portion 38, and an elongated thin tube portion 51 that extends in the axial direction from the lower surface of the base portion 50. By assembling the third member 23 to the first member 21, the thin tube portion 51 is inserted into the vertical liquid flow path 32. The tip of the thin tube portion 51 is press-fitted into the vertical liquid flow path 32 closer to the tip of the rod portion 28 than the horizontal liquid flow path 33.

[0081] An insertion tube 52 (forming an outlet for the drug solution) is provided at one end of the upper surface of the base portion 50. A cylindrical valve hole 53 is provided at the other end of the upper surface of the base portion 50. A horizontal hole 55 communicating with the thin tube portion 51 and the insertion tube 52 is formed inside the base portion 50.

[0082] The fourth member 24 is a member that is assembled onto the base portion 50, and has a lid portion 56 that is fitted into the bottom wall portion 37 so as to seal the tubular housing portion 38. The underside of the lid portion 56 is provided with an annular frame 57 that receives the insertion tube 52, and a cylindrical valve cylinder 58 with a bottom that is inserted into the valve hole 53. The valve cylinder 58 has a liquid outflow hole 60 that penetrates its side surface.

[0083] The upper surface of the lid 56 is formed with a cylindrical injection port 61 (forming an inlet for the drug solution) that communicates with the interior of the valve cylinder 58, and an insertion hole 62 into which the insertion tube 52 is inserted. An O-ring 63 attached to the insertion tube 52 seals the gap between the annular frame 57 and the insertion hole 62. The valve cylinder 58 is housed in the valve hole 53 with a silicone tube 65 attached that forms a check valve.

[0084] By assembling the third member 23 and the fourth member 24 to the first member 21, an inlet and an outlet for the chemical solution are provided in the connecting portion 26C.

[0085] 5 and 6, the cover portion 25 is a member that is fitted to the connecting portion 26C from the outside. In this embodiment, the cover portion 25 is composed of a pair of divided parts 67 (a first divided part 67a and a second divided part 67b) that are connected by a hinge 66. Each of these divided parts 67 is fitted to the connecting portion 26C in the direction perpendicular to the axis.

[0086] Each of the divided parts 67 has a semi-cylindrical wall portion 70 and a semi-annular edge portion 71 that protrudes radially inward from the upper end of the semi-cylindrical wall portion 70. One side portion (connecting side portion 72) of each of the semi-cylindrical wall portions 70 is connected to each other via a hinge 66.

[0087] The other side (engagement side portion 73) of the semi-cylindrical wall portion 70 of the first separate part 67a is provided with a pair of engagement claws 75. The engagement side portion 73 of the semi-cylindrical wall portion 70 of the second separate part 67b is provided with a pair of engagement grooves 76. The two separate parts 67 are connected by bending the hinge 66 to butt the engagement side portions 73 of the semi-cylindrical wall portions 70 of each separate part 67 together and inserting the engagement claws 75 into the engagement grooves 76.

[0088] This forms a cylindrical cover portion 25. The outer peripheral surface of the cover portion 25 is used as a place to attach an information label bearing information required for the infusion device 1, such as the product name, product number, and lot number.

[0089] 4 and 6, a cap 80 that freely closes and closes the injection port 61 is attached to the first separate part 67a. The cap 80 is molded integrally with the first separate part 67a via a pair of support arms 81, 81 and a spring hinge 82. The cap 80 is disposed in a direction perpendicular to the connecting side portion 72 and the engaging side portion 73 when viewed in the axial direction.

[0090] A plurality of (four in this embodiment) outer ridges 83 that fit with the respective inner ridges are formed on the inner surface of each semi-cylindrical wall portion 70. Specifically, each outer ridge 83 protrudes radially inward and extends circumferentially, and is arranged alternately with each inner ridge 42 in the axial direction (the inner ridges 42 and the outer ridges 83 form an uneven shape).

[0091] Also formed on the inner surface of each semi-cylindrical wall portion 70 are outer longitudinal grooves 84 that extend axially from the underside of the semi-annular edge portion 71 and penetrate the semi-cylindrical wall portion 70 so as to be symmetrical with respect to the central axis J. Each outer longitudinal groove 84 is formed by recessing the inner surface of each semi-cylindrical wall portion 70, including the outer ridge portion 83. These outer longitudinal grooves 84 are arranged in a direction perpendicular to the connecting side portion 72 and the engaging side portion 73 when viewed from the axial direction.

[0092] 6 and 7 , a fitting groove 85 into which the flange portion 46 fits is formed in the inner corner portion that is the boundary between the semi-cylindrical wall portion 70 and the semi-annular edge portion 71. A pair of straight portions 86 (forming a positioning structure) that fit into the cutout portions 47 are formed in the fitting groove 85 at the locations where the connecting side portion 72 and the engaging side portion 73 are located.

[0093] Therefore, the relative circumferential position of the cover portion 25 with respect to the connect portion 26C is fixed, and each inner longitudinal groove 43 and each outer longitudinal groove 84 always face each other. Furthermore, the cover portion 25 does not shift circumferentially with respect to the connect portion 26C. The axial position of the cover portion 25 with respect to the port 7 is also fixed. By fitting the cover portion 25 to the connect portion 26C, the cap 80 can be appropriately positioned with respect to the injection port 61.

[0094] As described above, a pair of connecting margins 17, 17 protrude from both sides of the neck portion 16. When fitting the cover portion 25 to the connect portion 26C, the neck portion 16 is sandwiched between them, and these connecting margins 17 get in the way. In contrast, in this infusion device 1, a pair of outer vertical grooves 84, 84 are formed in the cover portion 25. Therefore, as shown in FIG. 4 , the pair of connecting margins 17, 17 can be accommodated in these outer vertical grooves 84, 84. This prevents the connecting margins 17 from getting caught and the neck portion 16 from being damaged.

[0095] Furthermore, the joint margin 17 of the neck portion 16 is provided with a narrow width portion 18. This further reduces the risk of the joint margin 17 getting caught and damage to the neck portion 16. By accommodating the joint margin 17 in the outer longitudinal groove 84, the neck portion 16 can be properly sandwiched by the uneven shape formed by the outer ridge portion 83 and the inner ridge portion 42, as shown in Figure 7. This allows the port 7 to be securely fixed to the bag 5 even if the bag 5 and the port 7 are made of different materials.

[0096] <Using the Infusion Device> The use of the infusion device 1 will be described with reference to Figures 4, 8, etc. The use of the infusion device 1 is broadly divided into filling with medicinal liquid and administering the medicinal liquid. When unused, the infusion device 1 has a sheet-like bag 5, as shown in Figure 1, which is lightweight and compact. The flow path of the infusion tube 8 is closed by a clamp 10.

[0097] (Filling of medicinal liquid) As shown by arrow Y1 in Figure 4, the cap 80 is removed and the medicinal liquid is injected into the injection port 61 using a syringe or the like. The injected medicinal liquid flows into the valve cylinder 58 and flows out of the liquid outflow hole 60 into the valve hole 53 against the silicone tube 65. When the injection of the medicinal liquid stops, the liquid outflow hole 60 is closed by the silicone tube 65. Therefore, backflow of the medicinal liquid is prevented.

[0098] The valve hole 53 is in communication with the vertical liquid flow path 32, and as shown by arrow Y2 in Figures 4 and 8, the liquid flows from the rod portion 28 through the outer portion of the narrow tube portion 51 of the vertical liquid flow path 32 and the horizontal liquid flow path 33 into the inside of the balloon 6. This causes the medicinal liquid to be filled into the balloon 6. As the amount of medicinal liquid filled increases, the balloon 6 expands, as shown in Figure 8. As the balloon 6 expands, the bag 5 also expands.

[0099] Even at the mating portion between the cover portion 25 and the connecting portion 26C, an air passage (a gap 45 extending in the axial direction inside the neck portion 16) is secured by the inner longitudinal grooves 43. Moreover, since each inner longitudinal groove 43 is configured to face each outer longitudinal groove 84, the air passage is stably secured.

[0100] As a result, the area outside the balloon 6 inside the bag 5 is in communication with the outside world via the ventilation passage, so that even if there is air inside the bag 5, it is exhausted as shown by the arrow Y3 in FIG.

[0101] This allows the balloon 6 to expand until it is restricted by the bag 5, allowing the bag 5 to be filled with a predetermined volume (e.g., 500 ml) of medicinal solution. Excessive expansion of the balloon 6 can be prevented. Although the balloon 6 becomes thinner due to expansion, damage to the balloon 6 can be prevented because it is covered by the bag 5.

[0102] (Administration of medicinal liquid) The clamp 10 is operated to open the flow path of the liquid supply tube 8. By doing so, as shown by arrow Y4 in Figures 4 and 8, the pressure caused by the contraction of the balloon 6 causes the medicinal liquid to flow from the tip of the rod portion 28 into the vertical liquid flow path 32. The medicinal liquid that has flowed into the vertical liquid flow path 32 flows into the narrow tube portion 51 and then into the liquid supply tube 8 through the horizontal hole 55 and the insertion tube 52.

[0103] The flow of the medicinal liquid that has flowed into the liquid supply tube 8 is restricted by the orifice tube 13, and it flows out of the connector 12 at a predetermined flow rate. After that, air is removed, and the connector 12 of the liquid supply tube 8 is connected to a winged needle or the like. The orifice tube 13 is set so that the required flow rate can be maintained until the balloon 6 contracts and the medicinal liquid is almost gone. Therefore, the medicinal liquid can be used appropriately with almost no waste.

[0104] The infusion device 1 is portable like a conventional infuser, allowing treatment at any location and facilitating patient mobility. Therefore, the infusion device 1 is highly portable and convenient when in use. Furthermore, the infusion device 1 without any medicinal solution is lightweight and compact. Therefore, even if multiple infusion devices 1 are used, they are not bulky and are easy to carry. Therefore, the infusion device 1 is also highly convenient when unused and when disposed of.

[0105] To improve the portability of the infusion device 1 during use, the cover part 25 may be formed with a hole, particularly a through-hole 90, through which a strap can be inserted. FIG. 9 shows a specific example of the through-hole 90. As shown in the upper right and upper left views of FIG. 9 , a protruding piece 91 may be provided at the end of the cover part 25, and the through-hole 90 may be formed therein. Alternatively, as shown in the lower right and lower left views of FIG. 9 , the through-hole 90 may be formed in the side of the cover part 25. Alternatively, the hole may not be a through hole. For example, a hole may be provided so that a socket-shaped object can be inserted and fixed at the end where the strap is fixed, or a rod-shaped fixing part may be provided near the opening of a recess-shaped hole that is open on only one side, and the strap may be wrapped around the fixing part.

[0106] By attaching a strap to the infusion device 1, it is possible to hang the infusion device 1 around the patient's neck or shoulder, thereby improving the portability of the infusion device 1 during use.

[0107] The disclosed technology is not limited to the above-described embodiment, but also includes various other configurations.

[0108] In another embodiment, a fitting portion having a spiral concave-convex shape may be provided between the cover portion 25 and the connecting portion 26C, and the cover portion 25 may be configured to be screwed onto the connecting portion 26C from the axial direction. The ventilation passage may be configured by forming a hole that penetrates the bottom wall portion 37 in the axial direction.

[0109] In this embodiment, both the outer peripheral surface of the connector and the inner peripheral surface of the cover have circumferential irregularities, but either the outer peripheral surface of the connector or the inner peripheral surface of the cover may have circumferential irregularities. In this case, for example, by making either the outer peripheral surface of the connector or the inner peripheral surface of the cover flat and without irregularities, the molding flexibility of one of them increases, allowing the infusion device 1 to be produced efficiently.

[0110] In this embodiment, the inner longitudinal grooves 43 and the outer longitudinal grooves 84 are opposed to each other, but they do not necessarily have to be opposed to each other. On the other hand, by opposing the inner longitudinal grooves 43 and the outer longitudinal grooves 84, when inserting the neck portion 16 of the bag 5 into the port 7, it is possible to align the joint margins 17 with the inner longitudinal grooves 43, which makes it easier to align the joint margins 17 with the outer longitudinal grooves 84 of the cover 25, and there is no unevenness in the groove portions, ensuring space for the air passages, which is more preferable.

[0111] REFERENCE SIGNS LIST 1 infusion device 2 bag assembly 3 tube assembly 5 bag 6 balloon 7 port 8 infusion tube 10 clamp 11 filter 12 connector 13 orifice tube (flow rate setting portion) 15 body portion 16 neck portion 17 joint margin 18 narrow width portion 21 first member 22 second member (support portion) 23 third member (connect portion) 24 fourth member (connect portion) 25 cover portion 26C connect portion 26S support portion 27 inner support portion (support portion) 28 rod portion 29 fitting portion (connect portion) 32 vertical liquid flow path 33 horizontal liquid flow path 36 outer support portion 40 cylindrical wall portion 42 inner convex rib portion (uneven shape) 43 inner vertical groove 45 gap (ventilation passage) 46 flange portion 47 Notch portion (positioning structure) 48 Inclined portion (slope portion) 52 Insertion tube (medicinal solution outlet) 60 Liquid outlet hole 61 Injection port (medicinal solution inlet) 66 Hinge 67 Separate part 80 Cap 83 Outer convex rib portion (uneven shape) 84 Outer vertical groove 86 Straight portion (positioning structure) J Central axis

Claims

1. An infusion device for continuously delivering a medicinal solution, comprising: a reversibly elastically deformable balloon for containing the medicinal solution and having an opening; a port for allowing the medicinal solution to flow in and out of the balloon; and a bag for containing the balloon, wherein the port has: a support section for supporting the opening of the balloon; a rod section extending from the support section to the inside of the balloon; a connect section having a cross-sectional area in an axial direction perpendicular to the central axis of the rod section that is larger than that of the support section and is provided with an inlet and an outlet for the medicinal solution; and a cover section fitted into the connect section from the outside, wherein the bag has: a bag-shaped body section; and a neck section provided at one end of the body section and covering the connect section, wherein the port is attached to the bag by containing the rod section together with the balloon in the body section through the neck section, and fitting the cover section into the connect section with the neck section interposed therebetween.

2. An infusion device as described in claim 1, wherein the mating portion consisting of the outer surface of the connecting portion and the inner surface of the cover portion has an uneven shape on at least one of the outer surface of the connecting portion and the inner surface of the cover portion to sandwich the neck portion.

3. An infusion device according to claim 2, wherein at least one of the connecting portion and the cover portion is formed so that the uneven shape extends in the circumferential direction of the central axis.

4. An infusion device as claimed in claim 1, wherein the bag is formed by joining the edges of a pair of overlapping synthetic resin sheets together at a specified width, excluding the opening in the neck portion.

5. An infusion device according to claim 1, wherein the neck portion is three-dimensionally shaped so as to be maintained in an open state.

6. An infusion device as described in claim 5, wherein the connecting portion has a flange portion that protrudes in a direction perpendicular to the axis and extends circumferentially around the central axis, and the flange portion receives the open end of the neck portion and fits into the cover portion.

7. An infusion device according to claim 1, wherein the connecting portion on the side of the support portion has a slope portion that slopes downward toward the support portion.

8. An infusion device as described in claim 4, wherein a pair of outer vertical grooves extending in the direction of the central axis are formed facing each other on the inner surface of the cover part which fits with the outer surface of the connect part, and when the cover part is fitted to the connect part, a pair of joint margins protruding on both sides of the neck part can be accommodated in the outer vertical grooves.

9. An infusion device as claimed in claim 1, wherein each of the connecting portion and the cover portion is provided with a positioning structure for fixing the relative positions of the connecting portion and the cover portion in the circumferential direction of the central axis.

10. An infusion device as described in claim 1, wherein an inner longitudinal groove extending in the direction of the central axis is formed on the outer surface of the connecting portion, and the inner longitudinal groove constitutes an air passage that connects the outer area of ​​the balloon inside the bag to the outside world.

11. The infusion device according to claim 1, wherein the cover portion is formed with a hole through which a strap can be inserted.

12. An infusion device as claimed in claim 1, further comprising a tube assembly for transporting the medicinal liquid pushed out from the balloon, said tube assembly comprising: a liquid delivery tube having one end connected to the outlet and a connector at the other end; and a flow rate setting section for setting the flow rate of the medicinal liquid being delivered, said flow rate setting section being constituted by an orifice tube provided in a portion of the liquid delivery tube and having a specific length and flow path cross section.

13. The infusion device according to claim 1, wherein the bag is made of a soft material.

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