The present disclosure generally relates to an applicator.
Heretofore, a method has been known in which two or more kinds of liquids are mixed and jetted to an affected area or the like to form an anti-adhesion material or a biological tissue adhesive, and an applicator for this purpose has been developed.
Such an applicator as just mentioned has a configuration wherein components which solidify when mixed together, for example, a solution containing thrombin and a solution containing fibrinogen, are fed to a position in the vicinity of an affected area in a separated state from each other, to be applied while being mixed in the affected area.
As a conventional applicator, there is one that includes two syringes containing individually different kinds of liquids and a nozzle for mixing liquids supplied from the syringes and jetting the mixed liquid (see, for example, Japanese Patent No. 5147465). The applicator described in Japanese Patent No 5147465 has a configuration in which the nozzle is connected to a gas supplying source for supplying a sterile gas, and the liquids are jetted together with the sterile gas. More specifically, this nozzle has a double tube structure composed of two inner tubes through which the liquids from each of the syringes flow, and an outer tube in which the two inner tubes are inserted and which allows the gas to flow through a gap between the outer tube and the inner tubes.
In addition, distal portions of the inner tubes constitute a confluence portion where they join, and the liquids are mixed with each other in the confluence portion, to form a mixture. The confluence portion is configured from a gas-permeable membrane which is permeable to gas but impermeable to liquid. Accordingly, when plungers of the syringes are pushed to perform a liquid jetting operation, the mixture can be jetted together with the sterile gas flowing into the confluence portion through the gas-permeable membrane.
In the nozzle configured as just mentioned, upon stopping of the liquid jetting operation, the mixture in the confluence portion may be excessively pushed back, or may be caused to retract (flow back), depending on the magnitude of the pressure of the gas flowing into the confluence portion. In this case, depending on the composition of the mixture, the mixture may solidify, resulting in clogging. If the jetting operation is attempted again in the state where clogging has occurred, the solidified mixture would obstruct the jetting of the liquid from the nozzle. Thus, there have been cases where a jetting operation is difficult to carry out due to such a situation.
An applicator is disclosed which can help prevent clogging of a nozzle from occurring when an applying operation is stopped.
In accordance with an exemplary embodiment, an applicator is disclosed, which can include a nozzle, the nozzle including a gas channel through which a gas flows, a plurality of liquid channels which are provided inside the gas channel and through which liquids flow, and a confluence portion which is located on a downstream side of the liquid channels and at which the liquid channels join, wherein of the gas channel, a portion between the liquid channels and the confluence portion is configured by a single gas-permeable tube composed of a gas-permeable membrane permeable to the gas but impermeable to the liquids, and the gas-permeable tube includes a plurality of independent channels which are independently connected to the liquid channels and through which the liquids flowing from the liquid channels flow toward the confluence portion together with the gas flowing in through the gas-permeable membrane.
The applicator as disclosed herein, wherein a sum of areas of parts of a cross-sectional shape of the gas-permeable tube which are relevant to the independent channels is 5% to 50% of an area of the cross-sectional shape of the gas-permeable tube.
The applicator as disclosed herein, wherein a thickness of a wall portion located between the adjacent independent channels is 3% to 30% of an outside diameter of the gas-permeable tube.
The applicator as disclosed herein, wherein a length of the independent channels is greater than a length of the confluence portion in a longitudinal direction of the nozzle.
The applicator as disclosed herein, wherein the liquids flowing through the plurality of liquid channels differ from each other in viscosity, the plurality of independent channels differ from each other in diametric size, and the liquid having a higher viscosity flows through the independent channel having a greater diametric size whereas the liquid having a lower viscosity flows through the independent channel having a smaller diametric size.
The applicator as disclosed herein, wherein the nozzle has a double tube structure having a plurality of inner tubes and an outer tube accommodating the inner tubes, the inner tubes function as the liquid channels, and a gap between the inner tubes and the outer tube functions as the gas channel.
The applicator as disclosed herein, wherein the outer tube has a partition wall portion separating the gas channel and the confluence portion from each other, and the partition wall portion constitutes a support portion supporting the gas-permeable tube.
The applicator as disclosed herein, wherein the outer tube has a reduced diameter portion reduced in inside diameter at an end portion on a downstream side thereof, and a space inside the reduced diameter portion constitutes the confluence portion.
The applicator as disclosed herein, wherein the gas-permeable tube has an outer peripheral portion on a downstream side thereof fixed to the reduced diameter portion through a fixing material fixing them in a gas-tight manner.
The applicator as disclosed herein, wherein the applicator includes liquid supplying means configured to supply the liquids to the nozzle, wherein the liquid supplying means is a syringe including a syringe outer cylinder, a gasket inserted in the syringe outer cylinder, a pusher operated to move the gasket in a longitudinal direction of the syringe outer cylinder, and liquid filled in a space defined by the syringe outer cylinder and the gasket.
According to the present disclosure, when the applying operation is stopped, the mixed liquid in the confluence portion is discharged by the gas flowing in through the gas-permeable tube provided upstream of the confluence portion. Therefore, the mixed liquid can be prevented from remaining in the confluence portion, and clogging of the confluence portion (jet port) can be prevented from occurring.
An applicator of the present disclosure will be described in detail below, on the basis of an exemplary embodiment illustrated in the accompanying drawings.
Note that in the following description, for convenience of explanation, the right side in
An applicator 100 shown in
As depicted in
Note that the syringe 1a is prefilled with the first liquid L1 and the syringe 1b is prefilled with the second liquid L2.
In the case of mixing the first liquid L1 and the second liquid L2 in a predetermined mixing ratio to prepare the mixed liquid L3 and making the mixed liquid L3 a biological tissue adhesive, one of the first liquid L1 and the second liquid L2 may be thrombin and the other agent may be fibrinogen. In accordance with an exemplary embodiment, in the case of making the mixed liquid L3 an anti-adhesion material, one of the agents may be carboxymethyl dextrin modified with succinimidyl group and the other may be a mixture of sodium hydrogen carbonate and sodium carbonate. Note that in the present embodiment, the viscosity of the first liquid L1 is higher than (or greater than) the viscosity of the second liquid L2.
The first liquid L1 and the second liquid L2 in such a combination as this alter, specifically gel (solidify), when mixed with each other. The gelation helps ensure, for example, that the material obtained upon mixing of the first liquid L1 and the second liquid L2 (hereinafter referred to also as “mixed liquid L3”) can reliably remain at a biological tissue (target region) to which it has been applied. In addition, since the mixture assuredly remains at the target region, it can reliably exhibit the function as a biological tissue adhesive or anti-adhesion material at the target region.
In accordance with an exemplary embodiment, the syringe 1a and the syringe 1b are substantially the same in configuration, except for a difference in size, namely, maximum internal volume, and, accordingly, the syringe 1a will be described below on a representative basis.
The syringe 1a can include a syringe outer cylinder 2 and a gasket 12. The syringe outer cylinder 2 can include a barrel portion 21 in the form of a bottomed cylinder, and a mouth portion (syringe side port portion) 22 formed to project at a bottom portion which is a distal wall portion 211 of the barrel portion 21.
The barrel portion 21 has an inside diameter and an outside diameter which are both constant along the center axis direction of the barrel portion 21. Note that the inside diameter of the barrel portion 21 of the syringe 1a is greater than the inside diameter of the barrel portion 21 of the syringe 1b. Similarly, the outside diameter of the barrel portion 21 of the syringe 1a is also greater than the outside diameter of the barrel portion 21 of the syringe 1b.
In addition, the barrel portion 21 of the syringe 1a and the barrel portion 21 of the syringe 1b are connected to each other at their intermediate portions in the center axis direction through a flange portion 23 having a plate-like shape. By this connection, the positional relationship between the syringe 1a and the syringe 1b can be restricted; for example, a state in which the syringe 1a and the syringe 1b are connected in parallel to each other is maintained.
The mouth portion 22 is a portion which has a tubular shape smaller in diametric size than the barrel portion 21 and which communicates with the barrel portion 21. Through the mouth portion 22, the first liquid L1 is discharged. Note that the mouth portion 22 is disposed at a position eccentric with respect to the center of the distal wall portion 211 of the barrel portion 21. In the present embodiment, the mouth portion 22 of the syringe 1a and the mouth portion 22 of the syringe 1b are equal in outside diameter.
The material constituting the syringe outer cylinder 2 is not particularly limited. For example, resin materials such as polypropylene, cyclic polyolefin, polyesters, poly(4-methylpentene-1), polycarbonate, etc. may be preferably used as the material because these can easily be molded. Note that the constituent material of the syringe outer cylinder 2 is preferably substantially transparent for assuring visibility of the inside.
In accordance with an exemplary embodiment, the gasket 12 is composed of an elastic body having a cylindrical or disk-like shape. The gasket 12 is accommodated in the barrel portion 21 (syringe outer cylinder 2) and is slidable within the barrel portion 21. In addition, a space surrounded by the gasket 12 and the barrel portion 21 can be filled with the first liquid L1. With the gasket 12 moved toward the distal side, starting from the filled state, the first liquid L1 can be discharged through the mouth portion 22.
The material constituting the gasket 12 is not specifically restricted. Examples of the material usable here include elastic materials such as various rubber materials such as silicone rubbers, etc., various thermoplastic elastomers such as polyurethane-based ones, styrene-ethylene-butylene-styrene (SEBS) type styrene-based ones, etc., and mixtures of them.
In addition, the syringe assembly 10 can further include a plunger 11. The plunger 11 is a member for operating the gaskets 12 collectively. The plunger 11 can include a plunger portion 111 connected to the gasket 12 of the syringe 1a, a plunger portion 112 connected to the gasket 12 of the syringe 1b, and a flange portion 113 serving as an operation section.
The plunger portion 111 is elongate in shape, and its distal portion is connected to the gasket 12 of the syringe 1a. Similarly, the plunger portion 112 is elongate in shape, and its distal portion is connected to the gasket 12 of the syringe 1b. The method for connection here is not particularly limited, and examples of the connecting method include screwing and fitting. Note that the plunger portion 111 is greater than the plunger portion 112 in diametric size (thickness).
In accordance with an exemplary embodiment, the flange portion 113 is plate-like in shape, and the plunger portions 111 and 112 extend distally from a distal surface of the flange portion 113. At the time of operating the applicator 100, for example, a thumb of one hand can be put on the flange portion 113 of the plunger 11, and an index finger and a middle finger of the hand can be put on the flange portion 23 of the syringe outer cylinder 2.
As shown in
The base portion 4 is provided at a proximal portion thereof with connection portions 41a and 41b. The connection portion 41a is composed of a cylindrical recessed portion, to the inside of which the mouth portion 22 of the syringe 1a is connected liquid-tight. Similarly, the connection portion 41b is composed of a cylindrical recessed portion, to the inside of which the mouth portion 22 of the syringe 1b is connected liquid-tight.
In addition, the base portion 4 is provided with a connection portion 42 at its surface on one side, specifically, its surface serving as a lower surface in a use state of the applicator 100. The connection portion 42 is composed of a cylindrical recessed portion, to which one end portion of a flexible tube 13 is connected liquid-tight. To the other end of the tube 13 is connected a bomb 14.
The bomb 14 can have an internal space filled with a high-pressure (compressed) gas G, and can supply the gas G to the applicator 100 (nozzle 3). The bomb 14 is equipped with an on-off valve (cock) 141 capable of controlling the supply and the stop of the supply of the gas G to the applicator 100. When using the applicator 100, the valve 141 is put into an open state. Note that the gas G is not particularly limited, and may be, for example, carbon dioxide. In addition, although the gas G is preferably in a sterile state, the gas G may or may not be in a sterile state. In addition, the internal pressure (gas pressure) of the bomb 14 is preferably not less than, for example, 0.05 MPa, more preferably in the range, for example, from 0.09 MPa to 0.11 MPa.
At an intermediate portion of the tube 13, there is disposed a filter 16 housed in a housing 15. The filter 16 can trap foreign matter mixed into the gas G, before the gas G is supplied to the applicator 100.
As shown in
The outer tube 5 includes a tube main body 51 which is tubular in shape, and a nozzle head 52 provided at a distal portion of the tube main body 51. The tube main body 51 has a proximal portion supported on the base portion 4, and communicates with the tube 13 connected to the base portion 4, which helps enable the gas G to be supplied to the outer tube 5. The tube main body 51 is so configured that a gap is formed between the inner tubes 6a and 6b which will be described later and the gas-permeable tube 9, and the gas G can flow through the gap. Thus, the outer tube 5 functions as a gas channel 53 through which the gas G flows.
As shown in
While the nozzle head 52 is composed as a separate body from the tube main body 51 in the present embodiment, the nozzle head 52 may be formed integrally with the tube main body 51.
In accordance with an exemplary embodiment, such an outer tube 5 can be provided at a distal portion thereof with a reduced diameter portion 54 which is reduced in inside diameter. To the reduced diameter portion 54, a distal portion of the gas-permeable tube 9 is secured. In addition, that space in the reduced diameter portion 54 which is located downstream of the gas-permeable tube 9 constitutes a confluence portion 55 in which the flows of the first liquid L1 and the second liquid L2 join. In the confluence portion 55, the first liquid L1 and the second liquid L2 are mixed with each other, whereby the mixed liquid L3 is prepared.
In addition, as shown in
In accordance with an exemplary embodiment, in the applicator 100, the outer tube 5 can be divided into a rigid portion 56 and a flexible portion 57 on the distal side of the rigid portion 56.
The rigid portion 56 is a portion which can account for not less than 60% of the outer tube 5 and which is formed from one of various metallic materials such as, for example, stainless steel, aluminum, copper, copper alloys, which can help ensure that the posture of the nozzle 3 as a whole can be maintained. For example, the nozzle 3 as a whole can be prevented from bending. Note that the sheath 8 is preferably formed from a constituent material similar to that of the rigid portion 56, a resin material such as low-friction high-density polyethylene, or a composite material thereof.
The flexible portion 57 is a portion formed, for example, from one of various thermoplastic elastomers based on polyvinyl chloride, polyurethane, polyamide, polyester or the like. The flexible portion 57 tends to be curved in a natural state where no external force is applied thereto. When the tubular sheath 8 covering the outer tube 5 is advanced in the direction of arrow A in
In such an outer tube 5 as this, the inner tube 6a and the inner tube 6b are accommodated. As shown in
The inner tube 6a has a proximal portion connected to the mouth portion 22 of the syringe 1a through the connection portion 41a of the base portion 4, which helps permit the first liquid L1 to flow through the inside of the inner tube 6a. Thus, the inside of the inner tube 6a functions as a first liquid channel 61 through which the first liquid L1 flows. Similarly, the inner tube 6b has a proximal portion connected to the mouth portion 22 of the syringe 1b through the connection portion 41b of the base portion 4, which helps allow the second liquid L2 to flow through the inside of the inner tube 6b. Thus, the inside of the inner tube 6b functions as a second liquid channel 62 through which the second liquid L2 flows.
In addition, distal portions of the inner tubes 6a and 6b are close to each other, and are independently connected to the gas-permeable tube 9. As depicted in
In addition, in the cross-sectional shape of the gas-permeable tube 9, the sum of the areas relevant to the first independent channel 91 and the second independent channel 92 preferably accounts for 5% to 50%, more preferably 20% to 30%, of the total area of the cross-sectional shape of the gas-permeable tube 9. With the gas-permeable tube 9 sized (in diameter) to satisfy the above-mentioned numerical range, the gas-permeable tube 9 can be made comparatively small in diametric size (thickness) while sufficiently securing the first independent channel 91 and the second independent channel 92. As a result, the nozzle 3 can be made comparatively small in diametric size (thickness). Accordingly, the nozzle 3 can be easily inserted into a trocar tube which is used in a laparoscopic operation and which is comparatively small in diameter, so that an applying operation can be conducted directly in that state.
In accordance with an exemplary embodiment, in the first independent channel 91, a distal portion of the inner tube 6a is fitted liquid-tight, which helps ensure that the first independent channel 91 and the first liquid channel 61 communicate with each other, and the first liquid L1 can flow through the first independent channel 91. In accordance with an exemplary embodiment, a distal portion of the inner tube 6b is inserted liquid-tight in the second independent channel 92, which helps ensure that the second independent channel 92 and the second liquid channel 62 communicate with each other, and the second liquid L2 can flow through the second independent channel 92. Note that as aforementioned, the viscosity of the first liquid L1 is higher than (or greater than) the viscosity of the second liquid L2, but the first liquid L1 can flow through the first independent channel 91 relatively easily, since the first independent channel 91 is greater in diameter than the second independent channel 92.
Thus, the gas-permeable tube 9 is supported at both ends thereof by the reduced diameter portion 54 and by the inner tubes 6a and 6b. By this, the gas-permeable tube 9 can be prevented from positionally deviating in the radial direction of the nozzle 3 during use of the applicator 100.
The gas-permeable tube 9 is composed of a gas-permeable membrane 93. The gas-permeable membrane 93 is formed with a multiplicity of pores (not depicted). Each of the pores pierces the gas-permeable membrane 93 in the thickness direction. The average pore diameter of the pores is not particularly limited, and can be preferably not more than 2 μm, for example. In addition, the gas-permeable membrane 93 has impermeability to the first liquid L1 and the second liquid L2 (water repellency), specifically, hydrophobicity.
Owing to such a configuration as above, the gas-permeable membrane 93 is permeable to the gas G but is impermeable to the first liquid L1 and the second liquid L2, which helps allow the gas G to flow into the first independent channel 91 and the second independent channel 92 through the gas-permeable membrane 93. In this case, the gas G having flowed into the first independent channel 91 flows downstream together with the first liquid L1 flowing downstream, and the gas G having flowed into the second independent channel 92 flows downstream together with the second liquid L2 flowing downstream. Therefore, the first liquid L1 and the second liquid L2 flow into the confluence portion 55 together with the gas G, and are mixed with each other to be the mixed liquid L3, which is jetted from the jet port 521 together with the gas G.
In addition, as shown in
In accordance with an exemplary embodiment, in the present disclosure, the confluence portion 55 is smaller (shorter) than in the case where the inside of the gas-permeable tube 9 constitutes a confluence portion, but the mixed liquid L3 in a uniform state can be obtained owing to the stepped portion 58, as aforementioned.
In addition, as shown in
In accordance with an exemplary embodiment, as aforementioned, the gas-permeable tube 9 can be circular in cross-sectional shape over its entire length. Therefore, the gas G can flow into the first independent channel 91 and the second independent channel 92 through any part of the gas-permeable membrane 93 in the circumferential direction. As a result, the gas G can be supplied into the first independent channel 91 and the second independent channel 92 in a proper quantity. Through the first independent channel 91 and the second independent channel 92, therefore, the gas G can be supplied also into the confluence portion 55 in a proper quantity. Consequently, the mixed liquid L3 which is jetted is reliably turned into a mist.
Note that when the jetting of the mixed liquid L3 is stopped, as shown in
Note that the configuration for providing the gas-permeable membrane 93 with hydrophobicity is not specifically restricted. For example, a hydrophobic material (for example, polytetrafluoroethylene) may be used as the constituent material of the gas-permeable membrane 93, or a surface of the gas-permeable membrane 93 may be subjected to a treatment for making it hydrophobic (for example, a plasma treatment).
In accordance with an exemplary embodiment, a distal portion of the gas-permeable tube 9 as above is inserted in the reduced diameter portion 54 of the outer tube 5, and is secured gas-tight to the latter through an adhesive (fixing material) 17 (see
In addition, as shown in
As shown in
Note that the adhesive 17 is not specifically restricted, and, for example, an acrylic ultraviolet-curing type adhesive can be used.
In accordance with an exemplary embodiment, that part of the gas-permeable tube 9 which makes contact with the adhesive 17 is preferably subjected beforehand to a surface treatment for enhancing adhesion between the part and the adhesive 17. The surface treatment is not specifically restricted. Examples of the surface treatment applicable include a plasma treatment, a primer treatment (for example, application of silane or titanate coupling agent), and application of a metallic sodium-containing fluororesin surface treatment agent (e.g., “TETRA-ETCH A” or “TETRA-ETCH B” (TETRA-ETCH is a registered trademark) produced by Junkosha Inc.).
Now, an operating state of the applicator 100 will be described.
First, as shown in
Next, an index finger and a middle finger of one hand are put on the flange portion 23 of the syringe outer cylinder 2, and a thumb is put on the flange portion 113 of the plunger 11. Thereafter, the jet port 521 of the nozzle 3 is directed toward a target region. In this state, then, a force is applied with the thumb, to push the plunger 11 toward the distal side, thereby performing an applying operation. As a result, as shown in
When the plunger 11 is further continually pushed, the first liquid L having flowed through the first liquid channel 61 is caused by the pushing force to flow through the first independent channel 91 in the gas-permeable tube 9, while the second liquid L2 having flowed through the second liquid channel 62 is caused by the pushing force to flow through the second independent channel 92 in the gas-permeable tube 9.
In this instance, as depicted in
As illustrated in
After a predetermined amount of the mixed liquid L3 is applied to the target region, the pushing force exerted on the plunger 11 is relaxed, to stop the applying operation. As a result, the supply of the first liquid L1 into the first independent channel 91 is stopped, and the supply of the second liquid L2 into the second independent channel 92 is stopped. In this supply stopped state in which the supply of the liquids is stopped, the first liquid L1 is remaining in the first independent channel 91, and the second liquid L2 is remaining in the second independent channel 92.
In accordance with an exemplary embodiment, in the supply stopped state, the gas G is flowing into the first independent channel 91 and the second independent channel 92 in a continued manner. As a consequence, the first liquid L1 in the first independent channel 91 and the second liquid L2 in the second independent channel 92 flow into the confluence portion 55, to be the mixed liquid L3, which is jetted from the jet port 521 (see
Note that in the confluence portion 55, the mixed liquid L3 might tend to remain as a residual liquid. In the present disclosure, however, the confluence portion 55 is located downstream of the first independent channel 91 and the second independent channel 92, so that the mixed liquid L3 in the confluence portion 55 can directly be blown downstream in a reliable manner by the gas G flowing into the confluence portion 55 from the upstream side (see
Furthermore, the gas G flows into the confluence portion 55 only from the first independent channel 91 and the second independent channel 92. With this configuration, the mixed liquid L3 in the confluence portion 55 can be securely prevented from flowing back against the gas pressure of the gas G which flows from the first independent channel 91 and the second independent channel 92. Accordingly, the mixed liquid L3 in the confluence portion 55 can be prevented from flowing back into the first independent channel 91 and the second independent channel 92. Consequently, clogging of the first independent channel 91 and the second independent channel 92 can also be prevented.
While the applicator of the present disclosure has been described with reference to the embodiment illustrated in the drawings, the disclosure is not limited to this. Each of the components of the applicator can be replaced with one having an arbitrary configuration that can exhibit the same or similar function to the original. In addition, arbitrary structures may be added.
Note that the number of the inner tubes has been two in the present embodiment, this is not limitative. For example, a single inner tube or three or more inner tubes may be provided. In addition, where only one inner tube is provided, the inner tube is configured from a double lumen tube or a tube having three or more lumens.
The applicator of the present disclosure includes a nozzle, the nozzle including a gas channel through which a gas flows, a plurality of liquid channels which are provided inside the gas channel and through which liquids flow, and a confluence portion which is located on a downstream side of the liquid channels and at which the liquid channels join, wherein of the gas channel, a portion between the liquid channels and the confluence portion is configured from a single gas-permeable tube composed of a gas-permeable membrane permeable to the gas but impermeable to the liquids, and the gas-permeable tube includes a plurality of independent channels which are independently connected to the liquid channels and through which the liquids flowing from the liquid channels flow toward the confluence portion together with the gas flowing in through the gas-permeable membrane. Therefore, when an applying operation is stopped, the mixed liquid obtained by mixing of the liquids can be prevented from flowing back.
Accordingly, the applicator of the present disclosure has industrial applicability.
The detailed description above describes an applicator. The invention is not limited, however, to the precise embodiments and variations described. Various changes, modifications and equivalents can be effected by one skilled in the art without departing from the spirit and scope of the invention as defined in the accompanying claims. It is expressly intended that all such changes, modifications and equivalents which fall within the scope of the claims are embraced by the claims.
This application is a continuation of International Application No. PCT/JP2013/068622 filed on Jun. 8, 2013, the entire content of which is incorporated herein by reference.
Number | Date | Country | |
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Parent | PCT/JP2013/068622 | Jul 2013 | US |
Child | 14991229 | US |