JP7633858B2 - Injection tool - Google Patents

Description

Application of Article 30, Paragraph 2 of the Patent Act On November 10, 2020, Kaneka Medics Corporation sold an injection device to Muranaka Medical Equipment Co., Ltd.

The present invention relates to an injection device that facilitates priming of medical devices before use, and in particular to an injection device for priming a delivery system for delivering a stent or the like to a treatment site in a biological lumen.

Medical tubular bodies, such as stents, are medical devices used to treat various diseases caused by narrowing or obstruction of internal lumens, such as the digestive tract, including the bile duct and pancreatic duct, and blood vessels, including the iliac artery. Medical tubular bodies include those that are placed in the lesion to expand the lesion, such as a narrowed or obstructed area, from the inside and maintain the inner diameter of the lumen, and those that entangle thrombi that have developed in or around the lesion and remove them to the outside of the body, restoring the inner diameter of the lumen at the lesion.

Before performing a procedure to place such a medical tubular object, such as a stent, in the living body, priming (injection) is performed to supply saline or the like to the medical device in order to prevent blood clots and reduce the effects of contact and friction with the living body, or to improve the operator's operability. Priming may involve adding a component with anticoagulant properties to the saline.

Priming can be performed by immersing the medical device in saline or by passing water through each lumen of the medical device. In particular, when priming a long, thin delivery device such as a stent, it is often not sufficient to simply immerse the entire delivery device in saline and prime it, since the lumen is thin and long, so a method of passing water through each lumen is used.

Some stent delivery devices have a port that can be used to pass water through the lumen, and in such cases, it is possible to prime the stent delivery device by passing saline through the water-passable port. Even if there are multiple lumens, all of the lumens can be primed by passing water through the water-passable port for each lumen, so priming is not a major burden for the surgeon.

However, some stent delivery devices do not have a lumen that communicates with a water port. For example, a stent delivery device may have two lumens, but have a water port that communicates with one of the lumens, but not with the other lumen. In this case, the stent delivery device has two lumens but only one water port, which creates difficulties when priming the lumen that does not communicate with the water port.

When priming a lumen that is not connected to a water port, for example, one possibility is to insert an injection needle into the opening of the lumen to prime it, but the stent delivery device is usually very thin, making such an operation extremely difficult and cumbersome, and there is also a risk of damaging the stent delivery device if the operation is performed incorrectly.

Patent document 1 discloses a priming device that facilitates priming in a medical balloon catheter. The balloon catheter tip side and the priming device are fixed in a form that covers and fits over the outside of the balloon catheter, and the priming device and a fluid supplying device are connected to supply priming liquid. Patent document 2 discloses a biological organ expansion device that includes a first distal tube, a stent-storing tubular member that can slide on the first distal tube, and a stent as a stent delivery catheter that delivers a stent into a patient's body, and there are two lumens to be primed. In addition, a tube member is arranged that forms a flow path that communicates the inside of the distal tube with the inside of the distal end side of the biological organ expansion device, and this flow path allows the priming liquid injected from the opening of the distal tube to flow into the inside of the distal end side of the biological organ expansion device, thereby priming the two lumens. In other words, by connecting what were originally two elongated lumens in a water-permeable manner, a single flow path is formed.

JP 2001-79093 A JP 2012-70775 A

The mechanism disclosed in Patent Document 1 can achieve priming only when there is one lumen to be primed; if there are two or more lumens, the priming liquid flows preferentially to the lumen that is easier to flow through (has less fluid resistance), and the remaining lumens are not primed sufficiently or are not primed at all. In the stent delivery system disclosed in Patent Document 2, the flow rate of the priming liquid decreases before it reaches the inside of the distal end of the biological organ expansion device, so priming takes time and it is difficult to completely remove the air around the stent. In addition, the need to provide a communication passage connecting the two long and narrow lumens makes the structure complicated, making it difficult to completely remove the air inside the stent delivery system.

The present invention was made in consideration of the above circumstances, and aims to provide an injection tool that can supply fluid to a medical elongated object having a stent or the like and easily remove air from the lumen in a medical elongated object having two lumen at the tip of a stent delivery system or the like, without the need for a complex structure for priming.

The present inventors conducted extensive research to solve the above-mentioned problems. As a result, they discovered that the above-mentioned problems could be solved by using the structure shown below, and completed the present invention. That is, the present invention provides the following injection device (hereinafter, sometimes referred to as a "priming device").
[1] A priming device for supplying a fluid to a medical elongated body, the priming device comprising an inner tube and an outer tube having the inner tube disposed within its lumen,
The priming device includes a flow control member and a tubular member;
The flow rate adjusting member has a core portion and a locking portion,
a core portion of the flow rate adjusting member is insertable into a distal end side lumen of the inner tube;
the locking portion of the flow rate adjusting member locks the insertion of the core portion into the distal end side lumen of the inner tube by abutting against the distal end of the inner tube,
The tubular member has a coupling portion and a body portion,
the coupling portion of the tubular member is configured to mate with the distal end of the outer tube;
The body of the tubular member is configured to be fluid-tight with a priming fluid supply.
The priming device.
[2] The priming device according to [1], wherein the tubular member has an inner cavity larger than the engaging portion from the connecting portion to at least a portion of the main body.
[3] The priming device according to [1] or [2], wherein the base end surface of the engagement portion of the flow rate adjusting member is shaped to cover 30% or more of the tip opening of the inner tube.
[4] A priming device described in any one of [1] to [3], wherein the engagement portion of the flow rate adjustment member has a recess that can fit into the tip end of the inner tube.
[5] A priming device described in any one of [1] to [4], wherein the connecting portion of the tubular member is formed with a diameter that widens toward the direction in which it fits into the tip of the outer tube.
[6] The priming device according to any one of [1] to [5], wherein the main body of the tubular member is integral with a priming fluid supplier.
[7] A priming device according to any one of [1] to [6], wherein a tip tip having a large outer diameter is formed at the tip of the inner tube.
[8] A medical system comprising an elongated medical body including an inner tube and an outer tube having the inner tube disposed within its lumen, and a priming device for supplying a fluid to the elongated medical body,
a stent for placement in a living body is stored in the elongated medical body,
The priming device includes a flow control member and a tubular member;
The flow rate adjusting member has a core portion and a locking portion,
The core of the flow rate adjusting member is insertable into the inner tube,
the locking portion of the flow rate adjusting member has a shape that covers a cross section of the inner tube,
The tubular member has a coupling portion and a body portion,
the coupling portion of the tubular member is configured to mate with the distal end of the outer tube;
The body of the tubular member is configured to be fluid-tight with a priming fluid supply.
Healthcare system.
[9] When the locking portion of the flow rate adjusting member and the distal end portion of the inner tube of the elongated medical body are fitted together, in order to visually check the distal end portion of the inner tube of the elongated medical body through the locking portion of the flow rate adjusting member,
the inner tube of the medical elongated body has a distal end portion with low transparency,
The medical system according to [8], wherein the engaging portion of the flow rate adjusting member is transparent.
[10] A priming method for supplying a fluid to a medical elongated body including an inner tube and an outer tube having the inner tube disposed within its lumen, using a priming device including a flow rate adjusting member and a tubular member, comprising:
a step of inserting a core portion of the flow rate adjusting member into the inner tube and causing a locking portion of the flow rate adjusting member to cover a cross section of the inner tube;
a step of fitting a coupling portion of the tubular member to a tip end portion of the outer tube and bringing a body portion of the tubular member into a liquid-tight state with a priming fluid supplier;
a first priming step of delivering a priming fluid from a priming fluid supply;
a step of causing a core portion of the flow rate adjusting member to be not inserted into the inner tube and a locking portion of the flow rate adjusting member to not cover a cross section of the inner tube;
Then, a step of fitting a coupling portion of the tubular member to a tip end portion of the outer tube and a body portion of the tubular member in a liquid-tight state with a priming fluid supplier;
a second priming step of delivering priming fluid from a priming fluid supply;
A priming method comprising:

The present invention also provides the following injection device.
[1] An injection device for supplying a fluid to a medical elongated object, the injection device comprising an inner tube and an outer tube having the inner tube disposed within its lumen,
The injection tool includes a flow rate adjusting member and a tubular member,
The flow rate adjusting member has a core portion and a locking portion,
a core portion of the flow rate adjusting member is insertable into a distal end side lumen of the inner tube;
the locking portion of the flow rate adjusting member locks the insertion of the core portion into the distal end side lumen of the inner tube by abutting against the distal end of the inner tube,
The tubular member has a coupling portion and a body portion,
the coupling portion of the tubular member is configured to mate with the distal end of the outer tube;
The body of the tubular member is configured to be fluid-tight with a priming fluid supplier.
[2] An injection device for supplying a fluid to a medical elongated body having an outer tube and an inner tube disposed in an inner cavity of the outer tube,
The injection device includes an insertion member and a tubular member,
The insertion member has a core portion and a locking portion,
The core portion is insertable into an inner cavity of the medical elongate body,
the engaging portion has a contact portion that comes into contact with an end portion of the medical elongated body,
The tubular member has an inner lumen into which an end of the outer tube can be placed.
[3] The tubular member has a connecting portion and a main body portion,
The coupling portion has an inner cavity in which an end of the outer tube is disposed,
The injection tool according to claim 2, wherein the main body portion is connectable to a fluid supplier that supplies fluid to the injection tool.
[4] An injection device described in any one of [1] to [3], wherein at least a portion of the inner diameter of the tubular member is larger than the outer diameter of the engaging portion.
[5] The injection device according to any one of [1] to [4], wherein the contact portion of the engaging portion covers 30% or more of the opening of the medical elongated body.
[6] The injection device described in any one of [1] to [5], wherein the engaging portion has a recess that fits into the end portion of the medical elongated body.
[7] The injection device according to [3], wherein the inner diameter of the end of the tubular member on the side of the coupling portion is larger than the inner diameter of the end of the tubular member on the side of the main body portion.
[8] The coupling portion has a first end which is an end portion on the main body portion side and a second end which is an end portion opposite to the first end,
The inner cavity of the coupling portion has a tapered portion whose inner diameter increases from the first end side toward the second end side,
The injection device according to claim 7, wherein the inner diameter of the second end is greater than the inner diameter of the first end.
[9] The injection device according to any one of [1] to [8], wherein the tubular member is integral with a fluid supplier that supplies fluid to the injection device.

According to the present invention, even in a medical elongated body having multiple internal cavities and at least one internal cavities that does not have a water passage port, priming can be performed with simple operation and with little risk of damaging the device.

1 is a schematic diagram showing an injection device according to a first embodiment of the present invention. 1 is a schematic diagram showing a usage form according to a first embodiment of the present invention; FIG. 4 is another schematic diagram showing a usage form according to the first embodiment of the present invention. FIG. 11 is a schematic diagram showing an injection device according to a second embodiment of the present invention. FIG. 11 is a schematic diagram showing an injection device according to a third embodiment of the present invention.

The present invention will be described in more detail below based on the following embodiment, but the present invention is not limited to the following embodiment, and can be modified as long as it meets the purpose described above and below, and all of these are included in the technical scope of the present invention. In addition, hatching and component symbols may be omitted in each drawing for convenience, but in such cases, the specification and other drawings should be referred to. In addition, the dimensions of various components in the drawings may differ from the actual dimensions because priority is given to helping understand the features of the present invention. In addition, in the present invention, the base end side refers to the direction toward the user or operator's hand in the longitudinal axis direction of the stent delivery catheter, and the tip side refers to the opposite direction to the base end side, i.e., the direction toward the patient on which the stent is placed.

The injection device of the present invention is for supplying a fluid to a medical elongated body that is composed of an inner tube and an outer tube with the inner tube disposed within the lumen. In other words, the injection device of the present invention is for supplying a fluid to a medical elongated body that has an outer tube and an inner tube disposed within the lumen of the outer tube.

Figure 1 shows Example 1 of the injection device of the present invention together with the distal end portion of a stent delivery catheter 11. As the distal end portion of the stent delivery catheter 11, an inner tube 21, an outer tube 31, a stent 41, and a distal tip 51 are shown, and other parts of the stent delivery catheter 11 are omitted from the illustration.

A tip tip 51 can be arranged at the tip of the inner tube 21. When the tip tip 51 is arranged at the tip of the inner tube 21, it is preferable that the lumen of the inner tube 21 and the lumen of the tip tip 51 communicate with each other. The configuration of Example 1 will be described below. In Example 1, the tip tip 51 is joined to the tip of the inner tube 21. The outer tube 31 is arranged to form a double tube on the outside of the inner tube 21. The tip tip 51 and the tip of the outer tube 31 are arranged in close positions, but have a space large enough for liquid to enter. The stent delivery catheter 11 has two lumens inside. One is a lumen formed inside the inner tube 21, which is a guidewire lumen for inserting a guidewire. In addition to the guidewire lumen, there is a stent storage lumen formed between the outer surface of the inner tube 21 and the inner surface of the outer tube 31, and the guidewire lumen and the stent storage lumen form separate lumens that are not mutually connected. Before using the stent delivery catheter 11, both the guidewire lumen and the stent storage lumen must be primed.

The guidewire lumen opens at the tip of the stent delivery catheter 11 as a circular cross section, which is the cross section of the inner lumen of the inner tube 21. The stent storage lumen opens at the tip of the stent delivery catheter 11 as a gap between the tip tip 51 and the outer tube 31. Usually, the guidewire lumen extends over the entire length of the stent delivery catheter 11 while maintaining an inner diameter that allows the guidewire to be inserted without any problems, whereas the stent storage lumen is often simply a gap that has no purpose for passing anything through, and there is a demand to make the gap as small as possible due to the medical procedure needs to make the outer diameter of the stent delivery catheter 11 thinner. For this reason, when comparing the fluid resistance of the guidewire lumen and the stent storage lumen, the fluid resistance of the stent storage lumen is often very large compared to the guidewire lumen, and if priming is simply performed simultaneously on the two lumens without using the injection tool of Example 1, most of the priming fluid flows into the guidewire lumen, and almost no priming fluid flows into the stent storage lumen.

When the tip tip 51 is provided at the tip of the inner tube 21, the outer diameter of the tip tip 51 can be made larger than the outer diameter of the inner tube 21. The tip tip 51 can be chamfered or rounded to reduce damage when it comes into contact with tissue in the patient's body cavity. The tip tip 51 can be molded as a separate member from the inner tube 21, and then the tip tip 51 and the inner tube 21 can be joined together. Alternatively, the tip tip 51 and the inner tube 21 can be molded as a monolithic member or one piece. When the tip tip 51 is provided at the tip of the inner tube 21, the tip of the inner tube 21 and the tip tip 51 should be understood to be synonymous.

In the first embodiment, the tip tip 51 has an abacus bead-like shape with a lumen. The tip tip 51 is the most distal part of the stent delivery catheter 11 in a treatment procedure in which the stent delivery catheter 11 is advanced along a guidewire in the patient's body cavity, and is preferably formed of a soft material with a rounded surface so as to minimize damage to the patient's body cavity. The tip tip 51 has a lumen communicating with the lumen of the inner tube 21, and has the same inner diameter as the inner tube 21. As another option, the inner diameter of the lumen provided in the tip tip 51 can be set slightly smaller than the inner diameter of the inner tube 21. In this case, although the sliding property of the guidewire passing through the lumen itself is slightly reduced, when the tip tip 51 advances through a highly occluded area in the patient's body cavity, the force of the surgeon trying to push the stent delivery catheter 11 is more easily transmitted to the tip, and the advantage of improved passability through the highly occluded area is obtained.

The stent 41 is a self-expanding stent, for example a mesh tube made of a superelastic alloy such as nickel-titanium alloy, and is held in a contracted state by the stent delivery catheter 11. The distal tip 51 is made of a flexible material and is formed into a tapered shape so as not to damage the walls of the internal lumen of the body, such as the digestive tract or blood vessels, when the stent delivery catheter 11 is delivered to the affected area (lesion).

The outer tube 31 is slidable with the inner tube 21 and the tip 51, and by pulling the outer tube 31 axially toward the operator, the stent 41 moves axially relative to the outer tube 31, and the outer tube 31 is released from covering the outside of the stent 41, releasing and deploying the stent 41. When attempting to move the outer tube 31 axially toward the base end (nearby) relative to the stent 41, there is a concern that the stent 41 may not be released from the outer tube 31 due to mutual friction, so a limiting member can be provided to limit the axial movement of the stent 41 toward the near side, but the limiting member is not shown in FIG. 1.

The injection tool includes a flow rate adjustment member 71 (hereinafter, sometimes referred to as an "insertion member") and a tubular member 81. The injection tool of Example 1 is composed of a flow rate adjustment member 71 and a tubular member 81.

The flow rate adjustment member (insertion member) 71 includes a core portion 71c and a locking portion 71a. In the injection device of Example 1, the flow rate adjustment member 71 has a locking portion 71a, a recess 71b, and a core portion 71c.

The locking portion 71a has a contact portion that contacts the end of the medical elongated body. In other words, the locking portion 71a abuts against the tip of the inner tube 21, thereby locking the insertion of the core portion 71c into the inner cavity of the tip side of the inner tube 21. In Example 1, as shown in FIG. 1, the locking portion 71a of the flow rate adjustment member 71 is structured to be able to abut against the tip tip 51, and can prevent the priming fluid from flowing into the inner cavity of the inner tube 21.

The engaging portion 71a preferably has a recess 71b that fits into the end of the medical elongate body. As in Example 1, by providing the recess 71b, the adhesion between the flow rate adjusting member 71 and the tip tip 51 can be increased, or a structure can be created in which the flow rate adjusting member 71 and the tip tip 51 can be detachably joined.

The core 71c can be inserted into the lumen of the medical elongated body. This can also be said to be insertable into the lumen of the tip side of the inner tube 21. As shown in FIG. 1, the presence of the core 71c and the engagement portion 71a arranged in the lumen of the inner tube 21 increase the fluid resistance of the inner tube 21 at the portion where the core 71c is inserted, thereby preventing the inflow of the priming fluid. In addition, the fixation stability of the flow rate adjustment member 71 and the tip tip 51 can be improved, and the risk of damage to the tip tip 51 and the tip of the inner tube 21 due to erroneous operation can be reduced. In Example 1, the engagement portion 71a and the recess 71b of the flow rate adjustment member 71 are formed from the same polypropylene, and the core 71c of the flow rate adjustment member 71 is formed from SUS304, which is a metal material. At that time, the core 71c is first molded from SUS304, and then the engagement portion 71a and the recess 71b are added to the predetermined positions by the insert molding method. In the present invention, the material, type, molding method, and other manufacturing methods are not particularly limited, and other materials, configurations, and manufacturing methods are not excluded. For example, the locking portion 71a, recessed portion 71b, and core portion 71c of the flow rate adjustment member 71 can all be integrally molded from the same material, or they can all be formed from different materials and then assembled.

The locking portion 71a and recessed portion 71b of the flow rate adjusting member 71 are preferably molded from a relatively elastic plastic resin to improve sealing when they come into contact with the end of the medical elongated body, the tip of the inner tube 21, and the tip tip 51. For example, polyolefin, polyolefin elastomer, polyester, polyester elastomer, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyethylene terephthalate, styrene olefin rubber, etc. can be used, and a blend material made by mixing two or more of these resins can be selected, and further, a multi-layer structure in which two or more types are laminated can be used, with each layer being made of the same or different materials.

The core 71c of the flow rate adjusting member 71 is preferably selected from materials having high rigidity to improve stability when inserted into the lumen of the medical elongated body or the distal lumen of the inner tube 21, or when detachably abutting against the distal tip 51, and is preferably selected from metal materials. Examples include stainless steel, nickel-titanium alloy, cobalt-chromium alloy, etc. When made of stainless steel, it is preferable to contain chromium or nickel from the viewpoint of biocompatibility and corrosion resistance, and for example, SUS301, SUS304, SUS316, SUS631, etc. can be selected. In particular, SUS304 is preferable, and in Example 1, SUS304 was used to make the core 71c. The surface of the core 71c can be appropriately coated for the purpose of improving sliding properties, corrosion resistance, etc.

The core 71c is not particularly limited as long as it has an outer diameter that can be inserted into the inner cavity of the inner tube 21, but if the clearance between the outer diameter of the core 71c and the inner cavity of the inner tube 21 is too small, excessive force is required to pull the core 71c out of the inner tube 21, making the pulling operation difficult. In addition, there is an increased risk of damaging the tip or tip tip 51 of the inner tube 21 when inserting the core 71c into the inner cavity of the inner tube 21. Conversely, if the clearance between the outer diameter of the core 71c and the inner cavity of the inner tube 21 is large, the function of increasing the fluid resistance of the inner cavity of the inner tube 21 is reduced, and there is a risk that the core 71c will easily fall out. For these reasons, the difference between the outer diameter of the core 71c and the inner diameter of the medical elongated body, such as the inner tube 21 or the lumen of the distal tip 51, is preferably 100 μm or more and 800 μm or less, more preferably 150 μm or more and 400 μm or less, and most preferably 225 μm or more and 300 μm or less.

To improve the adhesion between the recess 71b and the tip tip 51, it is desirable to provide irregularities on the inner surface of the recess 71b. In that case, it is preferable to set the maximum width of the irregularities to 500 μm or less in order to reduce the effect of liquid leakage due to the irregularities.

To improve the bonding between the recess 71b and the tip tip 51, it is desirable to form the recess 71b from a material with high tackiness. In this case, it is also possible to form only the recess 71b from a different material. Examples of materials with high tackiness include silicone-based materials, rubber-based materials, and elastomer-based materials.

In order to reduce the risk of damaging the distal tip 51 when the surgeon removes the core 71c or during the manufacturing process of the stent delivery catheter 11, it is desirable to make the core 71c have a tapered shape in which the outer diameter decreases toward the base end side of the stent delivery catheter 11. In Example 1, the core 71c extends toward the base end side of the stent delivery catheter 11, and there is no problem if it extends in a direction from the base end of the stent delivery catheter 11 toward the tip. In that case, the risk of being pierced or scratched by the distal end of the core 71c can be reduced by tapering the distal end of the core 71c or by providing a loop at the tip.

The tubular member 81 can have the end of the outer tube 31 disposed in its inner cavity. The tubular member 81 preferably has a coupling portion 81b and a main body portion 81a. When the tubular member 81 has the coupling portion 81b and the main body portion 81a, it is preferable that the coupling portion 81b has the end of the outer tube 31 disposed in its inner cavity, and the main body portion 81a can be connected to a fluid supply device 91 that supplies fluid to the injection tool. This can also be said to be preferable that the coupling portion 81b is configured to fit with the tip of the outer tube 31, and the main body portion 81a is configured to be liquid-tight with the priming fluid supply device 91. In the first embodiment, as shown in FIG. 1, the tubular member 81 has a main body portion 81a and a coupling portion 81b. The main body portion 81a of the tubular member 81 is a portion that can be coupled to a priming fluid supply device 91 that supplies a priming fluid. The priming fluid here is, for example, physiological saline, and a component having anticoagulant properties may be added to the physiological saline. Furthermore, the priming liquid is not limited to these, and may be other biocompatible liquids, buffer solutions, or liquids containing physiologically active substances. Examples of the fluid supplier 91 include a syringe and the like. The connection method is not particularly limited as long as it does not substantially cause liquid leakage, but it is possible to select a mechanism that pushes the fluid into the inner cavity of the connection part 81b and makes contact, a so-called luer lock mechanism that can connect to the inner cavity or outer surface of the joint by rotation, or other fitting mechanisms.

The inner diameter of the end of the tubular member 81 on the joint 81b side is preferably larger than the inner diameter of the end of the tubular member 81 on the main body 81a side. By making the inner diameter of the end of the tubular member 81 on the joint 81b side larger than the inner diameter of the end of the main body 81a side, it becomes easier to insert the stent delivery catheter 11 into the lumen of the tubular member 81.

The joint 81b of the tubular member 81 comes into contact with the outer tube 31 of the stent delivery catheter 11, so that the priming liquid is guided to flow into the lumen of the stent delivery catheter 11 when the priming liquid is supplied. Therefore, some liquid leakage is not a problem when the outer tube 31 of the stent delivery catheter 11 comes into contact with the joint 81b, and it is sufficient if the contact provides a roughly sealed state. The structure of the joint 81b of the tubular member 81 may be a cylindrical shape having an inner lumen. Alternatively, the structure of the joint 81b may be a cylindrical shape having an inner lumen and at least one of the outer surface and the inner surface is tapered, in which case the sealing performance is improved when the joint 81b of the tubular member 81 comes into contact with the outer tube 31 of the stent delivery catheter 11. In addition, the joint 81b may have a step at least on the inside, and this step improves the sealing performance when the joint 81b comes into contact with the outer tube 31.

The connecting portion 81b has a first end which is the end on the main body portion 81a side and a second end which is the end opposite to the first end, and the inner cavity of the connecting portion 81b has a tapered portion whose inner diameter increases from the first end side to the second end side, and the inner diameter of the second end is preferably larger than the inner diameter of the first end. Since the inner cavity of the connecting portion 81b has a tapered portion whose inner diameter increases from the first end side to the second end side, and the inner diameter of the second end is larger than the inner diameter of the first end, it is easy to insert the stent delivery catheter 11 into the connecting portion 81b of the tubular member 81, and the outer tube 31 can be sufficiently abutted near the first end of the connecting portion 81b. As a result, the priming liquid easily flows into the stent delivery catheter 11 during priming, and priming can be performed efficiently.

In Example 1, the recess 71b and the tubular member 81 are molded to have transparency. By making the recess 71b transparent, the tip tip 51 placed in the cavity of the recess 71b can be visually confirmed, so the priming state can be grasped without separating the recess 71b and the tip tip 51. In addition, when the recess 71b is placed over the tip tip 51, the joining operation can be performed while visually checking the joining state, so the risk of damage due to erroneous operation can be reduced. Furthermore, by making the tubular member 81 transparent, the position of the cavity, particularly the tip tip 51, can be visually confirmed even when the tubular member 81 is placed over it, so the risk of damage due to erroneous operation can be reduced. In addition, it is preferable to mold the tip tip 51 so as not to have transparency, and in Example 1, the tip tip 51 is colored blue and molded in a state of low transparency. This allows high visibility to be maintained even through the transparent recess 71b and tubular member 81, making it possible to check the priming state and reduce the risk of damage due to erroneous operation.

The injection tool of Example 1 is provided with the flow rate adjustment member 71 detachably attached to the distal tip 51 of the stent delivery catheter 11, and the tubular member 81 is provided without being attached to the stent delivery catheter 11. As a result, the flow rate adjustment member 71 not only functions as a protective member for the distal end side of the distal tip 51, but also provides a function of protecting the boundary between the distal tip 51 and the inner tube 21, which is inherently prone to differences in rigidity and prone to bending, kinking, and buckling, due to the presence of the core portion 71c of the flow rate adjustment member 71.

The method of using the injection device of Example 1 will be described. First, the stent delivery catheter 11 is removed from the product packaging. The distal tip 51 of the removed stent delivery catheter 11 has a flow rate adjustment member 71 attached to it in advance. Next, as shown in FIG. 2, a fluid supplier 91 filled with a priming liquid is connected to the main body 81a of the tubular member 81. Here, a syringe is used as the fluid supplier 91, and the tip of the syringe is fitted and fixed to the inner surface of the main body 81a of the tubular member 81. Then, the joint 81b of the tubular member 81 is gently pressed against the stent delivery catheter 11. When the priming fluid in the fluid supplier 91 is released while maintaining this state, the priming fluid does not substantially flow into the lumen of the inner tube 21 because the flow rate adjustment member 71 is attached in a form that blocks the opening at the tip of the distal tip 51, but flows into the stent storage lumen between the inner tube 21 and the outer tube 31 and is primed. After that, the tubular member 81 is removed from the outer tube 31, and the flow rate adjustment member 71 is removed from the inner tube 21. Then, as shown in FIG. 3, the flow rate adjustment member 71 is gently pressed against the outer tube 31 again, and in this state, the priming fluid in the fluid supplier 91 is released. Then, the priming liquid flows preferentially into the lumen with the smaller fluid resistance between the stent storage lumen and the guidewire lumen, and the guidewire lumen is primed. Finally, the tubular member 81 is removed from the stent delivery catheter 11, and all priming of the stent delivery catheter 11 is completed. After priming is completed, the treatment procedure is performed using the stent delivery catheter 11 that has been primed.

It is preferable that the tubular member 81 is integrated with a fluid supply 91 that supplies fluid to the injection tool. In other words, in the first embodiment, the tubular member 81 may have a structure in which the main body 81a is integrated with the fluid supply 91 in advance.

In other words, the injection device of Example 1 performs the first priming using the tubular member 81 after opening the stent delivery catheter 11, and then performs the second priming using the tubular member 81 after removing the flow rate adjustment member 71 that was detachably fixed to the stent delivery catheter 11, and all priming operations are completed. Therefore, the priming operation consists only of the operation of covering the stent delivery catheter 11 with the tubular member 81 and the operation of pulling out the flow rate adjustment member 71 from the stent delivery catheter 11. Since it does not include the operation of inserting an injection needle into the tip of the stent delivery catheter 11 to perform priming, there is no need for detailed and complicated work, and there is no risk of damaging the stent delivery catheter 11. Furthermore, there is no need to provide a special structure for priming in the stent delivery catheter 11 itself, and the application of the present invention is not particularly hindered as long as the stent delivery catheter 11 is a stent delivery catheter 11 that forms two lumens by two tubes arranged coaxially.

Figure 4 shows Example 2 of the injection device of the present invention together with the distal end portion of the stent delivery catheter 12. As the distal end portion of the stent delivery catheter 12, the inner tube 22, the outer tube 32, the stent 42, and the distal tip 52 are shown, and other parts of the stent delivery catheter 12 are omitted from the illustration.

The stent delivery catheter 12 has the same structure as the stent delivery catheter 11 shown in Example 1, with a distal tip 52 connected to the distal end of the inner tube 22, and the outer tube 32 arranged to form a double tube on the outside of the inner tube 22. A guidewire lumen is provided in the inner cavity of the inner tube 22, and a stent storage lumen is provided between the outer surface of the inner tube 22 and the inner surface of the outer tube 32. Furthermore, a stent 42 is placed in the stent storage lumen of the inner tube 22, and by sliding the outer tube 32 toward the base end in the axial direction, the stent 42 is pushed toward the distal end relative to the outer tube 32 and released and deployed.

The injection tool 62 of Example 2 includes a flow rate adjustment member (insertion member) 72 and a tubular member 82. Furthermore, the flow rate adjustment member 72 has an engagement portion 72a and a core portion 72c. The engagement portion 72a has a contact portion that contacts the end of the medical elongated body. Specifically, the engagement portion 72a can abut against the distal tip 52 so as to prevent the priming fluid from flowing into the lumen of the inner tube 22. By making the base end surface of the engagement portion 72a have a shape that does not create a large clearance when abutted against the distal end surface of the distal tip 52, the amount of liquid flowing into the lumen of the inner tube 22 during priming can be further reduced, and the flow of the priming fluid into the other lumen of the stent delivery catheter 11 can be realized.

The locking portion 72a of the flow rate adjusting member 72 is not particularly limited as long as it has a contact portion or a structure that can abut against the tip of the inner tube 22 or the tip tip 52, but in order to reduce the inflow of liquid into the lumen of the inner tube 22 to a certain extent, it is preferable that the base end surface of the locking portion 72a has a shape that covers, for example, 30% or more of the tip side opening of the inner tube 22. Specifically, it is preferable that the contact portion of the locking portion 72a covers 30% or more of the opening of the medical elongated body. The shape of the contact portion of the locking portion 72a and the shape of the base end surface of the locking portion 72a are also not particularly limited, and may be flat or curved. It may also be approximately circular, approximately oval, or approximately rectangular.

Furthermore, by providing a core 72c and setting the clearance with the inner cavity of the inner tube 22 small, it is possible to add the effect of reducing the amount of liquid flowing into the inner cavity of the inner tube 22 during priming. The material selection and processing method of the first embodiment can be used for the core 72c.

The tubular member 82 used is the same as the tubular member 81 in Example 1. Similarly, the structure, materials, manufacturing methods, and other ideas listed as options for the tubular member 81 can also be used for the tubular member 82 in Example 2.

It is preferable that at least a part of the inner diameter of the tubular member 82 is larger than the outer diameter of the locking portion 82a. To explain this by giving a specific example, in Example 2, the minimum inner diameter of the tubular member 82 is set to be smaller than the maximum outer diameter of the flow rate adjustment member 72. As a result, when priming is performed using the tubular member 82, the flow rate adjustment member 72 is simultaneously pressed against the distal tip 52 by the action of pressing the tubular member 82 against the stent delivery catheter 12, so that the gap between the flow rate adjustment member 72 and the distal tip 52 can be reduced, thereby reducing the phenomenon in which the priming liquid escapes into the lumen of the inner tube 22. At this time, the timing at which the minimum inner diameter portion of the tubular member 82 and the maximum outer diameter portion of the flow rate adjustment member 72 come into contact is important. If a large gap is created between the flow rate adjustment member 72 and the distal tip 52 when the minimum inner diameter portion of the tubular member 82 and the maximum outer diameter portion of the flow rate adjustment member 72 come into contact, the priming liquid will preferentially flow out into the space inside the inner tube 22, and the lumen of the stent delivery catheter 12 will not be primed properly. Therefore, the contact between the minimum inner diameter portion of the tubular member 82 and the maximum outer diameter portion of the flow rate adjustment member 72 and the contact between the tubular member 82 and the outer tube 32 must occur approximately simultaneously, and the inner and outer diameters of each member and the taper angle of the joint portion 82b of the tubular member 82 must be appropriately designed.

The injection tool of Example 2 is provided with the flow rate adjustment member 72 and the tubular member 82 removably attached to the distal tip 52 of the stent delivery catheter 12. As a result, the flow rate adjustment member 72 and the tubular member 82 not only function as protective members for the distal end side of the distal tip 52 of the stent delivery catheter 12, but also the presence of the core portion 71c of the flow rate adjustment member 72 provides a function of protecting the boundary portion between the distal tip 52 and the inner tube 22, which is inherently prone to differences in rigidity and is prone to bending, kinking, and buckling.

A method of using the injection tool of Example 2 will be described. As in Example 1, first, the stent delivery catheter 12 is removed from the product packaging. The flow rate adjustment member 72 and the tubular member 82 are attached to the distal tip 52 of the removed stent delivery catheter 12 in advance. Next, in order to check the connection between the tubular member 82 and the outer tube 32, the joint portion 82b of the tubular member 82 is gently pressed against the stent delivery catheter 12. When the priming fluid in the fluid supplier 91 is released while maintaining this state, the priming fluid does not substantially flow into the lumen of the inner tube 22 because the flow rate adjustment member 72 is attached in a form that blocks the opening at the distal end of the distal tip 52, but flows into the stent storage lumen between the inner tube 22 and the outer tube 32 and is primed. After that, the tubular member 82 is once removed from the outer tube 32, and the flow rate adjustment member 72 is removed from the inner tube 22. The flow rate adjusting member 72 is again gently pressed against the outer tube 32, and in this state, the priming fluid in the fluid supplier 91 is released. Then, of the stent storage lumen and the guidewire lumen, the priming liquid flows preferentially into the guidewire lumen, which has a substantially circular cross-sectional shape and low fluid resistance, and the guidewire lumen is primed. Finally, the tubular member 82 is removed from the stent delivery catheter 12, and all priming of the stent delivery catheter 12 is completed. After priming is completed, the treatment procedure is performed using the stent delivery catheter 12 for which priming has been completed. Note that the tubular member 82 may also have a structure in which the main body 82a is integrated with the fluid supplier 91 (not shown) in advance.

In other words, the injection device of Example 2 performs the first priming using the tubular member 82 after opening the stent delivery catheter 12, and then performs the second priming using the tubular member 82 after removing the flow rate adjustment member 72 that was detachably fixed to the stent delivery catheter 12, and all priming operations are completed. The priming operation consists of only the operation of covering the stent delivery catheter 12 with the tubular member 82 and the operation of pulling out the flow rate adjustment member 72 from the stent delivery catheter 12. Since it does not include the operation of inserting an injection needle into the tip of the stent delivery catheter 12 to perform priming, there is no need for detailed and complicated work, and there is no risk of damaging the stent delivery catheter 12. Furthermore, there is no need to provide a special structure for priming in the stent delivery catheter 12 itself, and the application of the present invention is not particularly hindered as long as the stent delivery catheter 12 has two lumens formed by two tubes arranged coaxially.

Figure 5 shows Example 3 of the injection device of the present invention together with the distal end portion of the stent delivery catheter 13. As the distal end portion of the stent delivery catheter 13, the inner tube 23, the outer tube 33, the stent 43, and the distal tip 53 are shown, and other parts of the stent delivery catheter 13 are omitted from the illustration.

The stent delivery catheter 13 has the same structure as the stent delivery catheter 11 shown in Example 1, with a distal tip 53 connected to the distal end of the inner tube 23, and the outer tube 33 arranged to form a double tube on the outside of the inner tube 22. A guidewire lumen is provided in the inner cavity of the inner tube 23, and a stent storage lumen is provided between the outer surface of the inner tube 23 and the inner surface of the outer tube 33. Furthermore, a stent 43 is placed in the stent storage lumen of the inner tube 23, and by sliding the outer tube 33 toward the base end in the axial direction, the stent 43 is pushed toward the distal end relative to the outer tube 33 and released and deployed.

The injection tool 63 of the third embodiment includes a flow rate adjustment member (insertion member) 73 and a tubular member 83. Furthermore, the flow rate adjustment member 73 has a locking portion 73a, a recessed portion 73b, and a core portion 73c.

The locking portion 73a of the flow rate adjustment member 73 can abut against the tip tip 53 to prevent the priming fluid from flowing into the lumen of the inner tube 23. In Example 3, a recess 73b is provided that exceeds the maximum outer diameter of the tip tip 53 and covers more than half of the axial direction, which provides excellent adhesion between the flow rate adjustment member 73 and the tip tip 53, and also allows the flow rate adjustment member 73 and the tip tip 53 to be detachably joined.

Furthermore, the presence of the core 73c and the placement of the core 73c in the lumen of the inner tube 23 improves the stability of the fixation of the flow rate adjustment member 73 and the tip tip 53, and also reduces the risk of damage to the tip tip 53 and the tip of the inner tube 23 due to incorrect operation. In Example 3, the axial length of the core 73c is shorter than the axial length of the tip tip 53, which not only simplifies the attachment and detachment of the core 73c, but also further reduces the risk of damage to the tip tip 53 and the tip of the inner tube 23 due to incorrect operation. It is more desirable to make the axial length of the core 73c shorter than half the axial length of the tip tip 53. The core 73c has a shape in which the outer diameter tapers toward the base end side in the axial direction. This improves the operability when removing the core 73c from the tip tip 53, and also reduces the risk of damaging the tip tip 53 when placing the core 73c in the lumen of the tip tip 53.

In Example 3, the locking portion 73a and the recessed portion 73b of the flow rate adjusting member 73 were made of the same polypropylene as in Example 1. The core portion 73c in Example 3 was made of SUS304 as in Example 1.

The main body 83a of the tubular member 83 is a portion that can be connected to a priming fluid supplier 91 that supplies priming liquid.

The joint 83b of the tubular member 83 engages with the outer tube 33 of the stent delivery catheter 13, so that the priming fluid is guided to flow into the lumen of the stent delivery catheter 13 when the priming fluid is supplied. Therefore, some leakage of fluid is not a problem when the outer tube 33 of the stent delivery catheter 13 is engaged with the joint 83b, and it is sufficient if the engagement provides a roughly sealed state. In Example 3, the joint 83b is cylindrical with a lumen and has a uniform inner and outer diameter over the entire axial length. This reduces the risk of damaging the stent delivery catheter 13 even if the tubular member 83 is mistakenly pushed toward the stent delivery catheter 13. In order to improve the airtightness of the joint between the joint 83b and the distal tip 53, small protrusions can be provided in the circumferential direction on the inner surface of the joint 83b.

The injection tool of Example 3 is provided with the flow rate adjustment member 73 detachably attached to the distal tip 53 of the stent delivery catheter 13, and the tubular member 83 is provided without being attached to the stent delivery catheter 13. As a result, the flow rate adjustment member 73 not only functions as a protective member for the distal end side of the distal tip 53 of the stent delivery catheter 13, but also provides a function of protecting the boundary between the distal tip 53 and the inner tube 23, which is inherently prone to differences in rigidity and is prone to bending, kinking, and buckling, due to the presence of the core portion 73c of the flow rate adjustment member 73.

The method of using the injection device of Example 3 will be described. First, the stent delivery catheter 13 is removed from the product packaging. The distal tip 53 of the removed stent delivery catheter 13 has a flow rate adjustment member 73 attached to it in advance. Next, a fluid supplier 91 filled with a priming liquid is connected to the main body 83a of the tubular member 83. Then, the joint 83b of the tubular member 83 is placed so as to cover the outer tube 33 of the stent delivery catheter 13. When the priming fluid in the fluid supplier 91 is released while maintaining this state, the priming fluid does not substantially flow into the lumen of the inner tube 23 because the flow rate adjustment member 73 is attached in a form that blocks the opening at the distal end of the distal tip 53, but flows into the stent storage lumen between the inner tube 23 and the outer tube 33 and is primed. After that, the tubular member 83 is once removed from the outer tube 33, and the flow rate adjustment member 73 is removed from the inner tube 23. The flow rate adjusting member 73 is again placed so as to cover the outer tube 33, and in this state, the priming fluid in the fluid supplier 91 is released. Then, of the stent storage lumen and the guidewire lumen, the priming liquid flows preferentially into the guidewire lumen, which has the smaller fluid resistance, and the guidewire lumen is primed. Finally, the tubular member 83 is removed from the stent delivery catheter 13, and all priming of the stent delivery catheter 13 is completed. After priming is completed, the treatment procedure is performed using the stent delivery catheter 13 for which priming has been completed. Note that the tubular member 83 may also have a structure in which the main body 83a is integrated with the fluid supplier 91 (not shown) in advance.

In other words, the injection device of Example 3 performs the first priming using the tubular member 83 after opening the stent delivery catheter 13, and then performs the second priming using the tubular member 83 after removing the flow rate adjustment member 73 that was detachably fixed to the stent delivery catheter 13, and all priming operations are completed. The priming operation consists of only the operation of covering the stent delivery catheter 13 with the flow rate adjustment member 73 and the operation of pulling the flow rate adjustment member 73 out of the stent delivery catheter 13. Therefore, since it does not include the operation of inserting an injection needle into the tip of the stent delivery catheter 13 to perform priming, there is no need for detailed and complicated work, and there is no risk of damaging the stent delivery catheter 13. Furthermore, there is no need to provide a special structure for priming in the stent delivery catheter 13 itself, and the application of the present invention is not particularly hindered as long as the stent delivery catheter 13 has two lumens formed by two tubes arranged coaxially.

11, 12, 13: Stent delivery catheter 21, 22, 23: Inner tube 31, 32, 33: Outer tube 41, 42, 43: Stent 51, 52, 53: Distal tip 71, 72, 73: Flow rate adjusting member 71a, 72a, 73a: Locking portion 71b, 73b: Recess 71c, 72c, 73c: Core portion 81, 82, 83: Tubular member 81a, 82a, 83a: Main body portion 81b, 82b, 83b: Joint portion 91: Fluid supplier

Claims (10)

An injection device for supplying a fluid to a medical elongated body, the injection device comprising an inner tube and an outer tube having the inner tube disposed within its lumen,
The injection tool includes a flow rate adjusting member and a tubular member,
The flow rate adjusting member has a core portion and a locking portion,
a core portion of the flow rate adjusting member is insertable into a distal end side lumen of the inner tube;
the locking portion of the flow rate adjusting member locks the insertion of the core portion into the distal end side lumen of the inner tube by abutting against the distal end of the inner tube,
The tubular member has a coupling portion and a body portion,
the coupling portion of the tubular member is configured to mate with the distal end of the outer tube;
The body of the tubular member is configured to be fluid-tight with a priming fluid supplier. An injection device for supplying a fluid to a medical elongated object, the injection device having an outer tube and an inner tube disposed in an inner cavity of the outer tube,
The injection device includes an insertion member and a tubular member,
The insertion member has a core portion and a locking portion,
the core is insertable into a lumen of the inner tube ;
the locking portion has a contact portion that comes into contact with the tip portion of the inner tube , and the contact portion abuts against the tip of the inner tube to lock the insertion of the core portion into the tip-side lumen of the inner tube,
The tubular member has an inner lumen into which an end of the outer tube can be placed. An injection device for supplying a fluid to a medical elongated object, the injection device having an outer tube , an inner tube disposed in an inner cavity of the outer tube, and a distal tip disposed at a distal end of the inner tube and communicating with an inner cavity of the inner tube,
The injection device includes an insertion member and a tubular member,
The insertion member has a core portion and a locking portion,
The core portion is insertable into the lumen of the distal tip ,
The locking portion has a contact portion that contacts the distal end of the distal tip , and the contact portion abuts against the distal end of the distal tip to lock the insertion of the core portion into the distal end lumen of the distal tip,
The tubular member has an inner lumen into which an end of the outer tube can be placed. the tubular member has a coupling portion and a body portion;
The coupling portion has an inner cavity in which an end of the outer tube is disposed,
4. The injection device according to claim 2 or 3 , wherein the main body portion is connectable to a fluid supply that supplies fluid to the injection device. The injection tool according to any one of claims 1 to 4 , wherein at least a part of an inner diameter of the tubular member is larger than an outer diameter of the engaging portion. The injection device according to any one of claims 1 to 5 , wherein the contact portion of the engaging portion covers 30% or more of the opening of the medical elongated body. The injection tool according to any one of claims 1 to 6 , wherein the engaging portion has a recess that fits onto an end portion of the medical elongated body. 5. The injection tool according to claim 4 , wherein an inner diameter of the end of the tubular member on the coupling portion side is larger than an inner diameter of the end of the tubular member on the main body portion side. The coupling portion has a first end which is an end portion on the side of the main body portion, and a second end which is an end portion opposite to the first end,
The inner cavity of the coupling portion has a tapered portion whose inner diameter increases from the first end side toward the second end side,
9. The injection device of claim 8 , wherein an inner diameter of the second end is greater than an inner diameter of the first end. 10. The injection tool according to claim 1 , wherein the tubular member is integral with a fluid supplier that supplies fluid to the injection tool.

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