JP5896101B2 - Catheter with valve - Google Patents

Description

  The present invention relates to a catheter used for injecting or aspirating liquids in the medical field, and more particularly to a valved catheter having a valved communication hole at a distal end portion.

  2. Description of the Related Art Conventionally, a catheter has been employed for injecting a drug solution, an infusion solution, or the like into a patient or sucking and collecting blood from the patient.

  By the way, if the tip of the catheter inserted into the patient's body is always open, there is a problem that measures against blood outflow and coagulation are required. Therefore, Japanese Patent Publication No. 4-77590 (Patent Document 1) proposes a catheter with a valve in which a slit-like communication hole is provided in a peripheral wall portion of the catheter whose tip is closed. In such a communication hole, when a positive pressure or a negative pressure is applied through the lumen of the catheter, the valve function is exhibited by opening the communication hole by opening a slit due to a pressure difference between the inside and the outside.

  However, the slit-shaped communication hole has a problem that it is difficult to open even if a negative pressure is applied. In particular, it has been found that if the catheter material is hardened for the purpose of improving the operability by the catheter procedure, it is extremely difficult to open the slit-shaped communication hole even when a large negative pressure is applied.

  Note that Japanese Patent No. 2563755 (Patent Document 2) proposes a structure in which a tongue-shaped flap valve is formed on the peripheral wall portion of the catheter, but the flap is moved when the catheter is moved in a blood vessel or the like. There is a risk of the tip of the valve getting caught in a blood vessel or the like. For this reason, there is a possibility that blood vessels or the like are damaged by the flap valve, and the operability of the catheter is deteriorated. In particular, when the catheter material is hardened, the problem due to the trapping of the flap valve on the blood vessel and the like becomes even greater.

Japanese Patent Publication No. 4-77590 Japanese Patent No. 2563755

  The problem to be solved by the present invention is that even when the material of the catheter is hardened, the switching operation between the communication state and the blocking state by the valve body of the communication hole provided in the peripheral wall is stably performed, and a blood vessel or the like It is an object of the present invention to provide a valve catheter having a novel structure in which the valve body is prevented from being caught.

A first aspect of the present invention is a valve-equipped catheter in which a communication hole provided with a valve body is provided in a peripheral wall portion of a flexible catheter having a closed end, and the peripheral wall separated from the distal end of the catheter the linear slit formed in the portion, together with the communication hole for injection having a slit valve as the valve body to open by the action of positive pressure into the lumen of the catheter is formed, a peripheral wall of said catheter The communication hole for suction provided with the flap valve as the valve body that is opened by the action of negative pressure on the lumen of the catheter is formed by the curved slit formed in the portion, and the flap valve An outward deformation limiting means for limiting the protrusion deformation toward the catheter outer peripheral side is provided, and the relative pressure to the outside of the lumen of the catheter is at least +7 mmHg to −80 mmH Within the scope of the valved catheter neither of said flap valve and said slit valve is closed is maintained, characterized.

  In the catheter with a valve of this aspect, a communication hole for injection provided with a slit valve and a communication hole for suction provided with a flap valve are employed in combination with each other. Thereby, when injecting infusion etc. through the lumen | bore of a catheter, the slit valve which is easy to open with a positive pressure is open | released, and injection | pouring of infusion etc. through the communicating hole for injection can be performed stably. On the other hand, when sucking blood or the like through the lumen of the catheter, the flap valve that is easily opened by negative pressure is opened, so that the blood or the like can be stably sucked through the suction communication hole.

  In particular, since the slit valve provided in the communication hole for injection does not rise like a protrusion on the outer peripheral side of the catheter, it is not caught in a blood vessel or the like even in an open state, of course. Therefore, there is no problem that the blood vessel is damaged due to the valve body being caught on the blood vessel or the like, or the catheter operability is lowered.

  In addition, the flap valve provided in the communication hole for suction has a larger area than the slit valve for deformation due to negative pressure. This communication hole can be easily brought into a communication state. Therefore, for example, the switching operation between the communication state and the shut-off state of the valve body is stably and surely performed in each of the communication holes for injection and suction, and the hardness of the catheter is increased to improve the operability by the procedure. It is possible to improve the system.

  In this aspect, it is desirable to provide outward deformation limiting means for limiting the protrusion deformation to the catheter outer peripheral side in the flap valve. That is, the flap valve has a larger section modulus (Z) due to the curved shape in the circumferential direction of the catheter, and can effectively exert the deformation resistance force and the buckling strength toward the outer peripheral side of the catheter. By providing the means, it is possible to more reliably prevent the flap valve from projecting and deforming toward the outer peripheral side of the catheter when injecting an infusion solution or the like through the catheter. For example, as described in the embodiment, the outward deformation limiting means includes a curved slit that forms a flap valve as an inclined surface with respect to the peripheral wall of the catheter, and the curved slit end surface of the catheter with respect to the outer peripheral end surface of the flap valve. It is configured by overlapping from the outer peripheral side of the catheter. Alternatively, a locking protrusion that is locked to the inner peripheral surface of the catheter to prevent the flap valve from being displaced outward is provided on the flap valve, or a ring that prevents the outward displacement by pressing the flap valve from the outside. The outward deformation limiting means is also configured by attaching a pressing member such as a tape or the like to the catheter.

  A second aspect of the present invention is a valved catheter according to the first aspect, wherein the material of the catheter is a Shore A hardness of 70-100.

  By adopting such Shore A hardness, the operability of the procedure in the catheter can be improved, and there is provided a communication hole for injection provided with a slit valve and a flap valve as described above. In addition, by adopting a combination with the communication hole for suction, injection of infusion and the like and suction of blood and the like can be performed easily and reliably.

  A third aspect of the present invention is a valved catheter according to the first or second aspect, wherein the catheter is provided with a single lumen, and the slit valve and the flap valve are provided. , Provided on the opposite side across the central axis of the catheter.

  By adopting such an arrangement form of the slit valve and the flap valve, a large degree of freedom in designing the position and size of providing the communication hole for injection and the communication hole for suction is ensured. That is, both the slit valve and the flap valve are formed by forming slits on the peripheral wall of the catheter, but by providing these valves on the opposite sides, the deformation strength and the bending rigidity of the catheter by forming the slits. It is possible to suppress adverse effects on the like. Further, by providing the slit valve and the flap valve on the opposite sides, for example, both the infusion communication hole and the suction communication hole can be provided sufficiently close to the distal end of the catheter.

  In the valved catheter having the structure according to the present invention, the injection of infusion or the like is performed by opening the slit valve, so that the blood vessel or the like is prevented from being caught due to the protrusion of the valve body to the outer periphery of the catheter. In addition, since suction of blood or the like is performed by opening the flap valve, the valve body can be easily and reliably opened, and suction of blood or the like can be performed stably.

The front view of the catheter with a valve | bulb as embodiment of this invention. The rear view of the catheter with a valve shown in FIG. III-III sectional drawing in FIG. IV-IV sectional drawing in FIG.

  Embodiments of the present invention will be described below with reference to the drawings. 1-4 show a catheter 10 with a valve as an embodiment of the present invention. This valved catheter 10 is inserted into a patient's blood vessel, for example, and used to inject a drug solution or nutrient solution into the blood vessel, or to suck and collect blood from the blood vessel.

  More specifically, the valved catheter 10 is configured using a tubular catheter body 14 having a single lumen 12. 1-4, only the distal end side, which is the main part of the catheter 10 with a valve, is shown. An appropriate port is connected to the proximal end side of the catheter body 14. The material of the catheter body 14 is not particularly limited, but is formed of an elastic material such as soft polyurethane or silicone, and has an appropriate flexibility so that it can be inserted into a blood vessel or the like.

  Further, a blocking member 16 is fixed to the distal end of the catheter body 14 to block the distal end opening of the lumen 12.

  Further, an injection communication hole 20 and a suction communication hole 22 are formed in the peripheral wall portion near the distal end of the catheter body 14. In particular, in the present embodiment, the injection communication hole 20 and the suction communication hole 22 are located on the opposite sides in the tube diameter direction of the catheter body 14 (opposite sides across the central axis of the catheter body 14). Moreover, they are formed at substantially the same position in the tube length direction of the catheter body 14 and are opposed to each other in the vertical direction in FIGS.

  The communication hole 20 for injection includes a slit valve 26 as a valve body formed by a linear slit 24 extending in the tube axis direction with respect to the peripheral wall portion of the catheter body 14. In this embodiment, the linear slit 24 that forms the slit valve 26 is formed with a cut surface that extends in the radial direction passing through the central axis of the catheter body 14 and is orthogonal to the peripheral wall of the catheter body 14.

  As indicated by phantom lines in FIG. 3, the slit valve 26 has both sides sandwiching the linear slit 24 outward when the pressure in the lumen 12 of the catheter body 14 is higher than the external pressure. Elastically deforms. Then, the both sides of the linear slit 24 are separated from each other so as to open outward, so that the injection communication hole 20 appears in a communication state on the linear slit 24. When the pressure difference between the lumen 12 of the catheter body 14 and the outside disappears, both sides of the linear slit 24 constituting the slit valve 26 are restored to the original shape by elasticity and are closely attached to each other, and the infusion communication hole 20 Is cut off.

  On the other hand, the suction communication hole 22 includes a flap valve 30 as a valve body formed by a curved slit 28 extending in a substantially U shape with respect to the peripheral wall portion of the catheter body 14. In the present embodiment, the flap valve 30 has a predetermined width in the circumferential direction of the catheter body 14 and extends from the distal end side to the proximal end side in the tube axis direction of the catheter body 14 (from the right side to the left side in FIG. 2). It is in the shape of a tongue that extends.

  Further, in the present embodiment, the curved slit 28 forming the flap valve 30 is formed with a cut surface that is cut and inclined with respect to the peripheral wall of the catheter body 14. The cut surface is inclined in the outer peripheral direction of the flap valve 30 from the outer peripheral surface of the catheter main body 14 toward the inner peripheral surface, and the outer peripheral shape of the flap valve 30 is closer to the inner peripheral surface from the outer peripheral surface of the catheter main body 14. Is inclined in the direction of gradually increasing.

  As shown by the phantom line in FIG. 4, the flap valve 30 is a curved slit that is shaped like a tongue when the pressure in the lumen 12 of the catheter body 14 is lower than the external pressure by a predetermined pressure. The inner peripheral side of 28 is elastically deformed inward. The suction communication hole 22 appears in a communication state on the curved slit 28 by separating the curved slit 28 toward the inner peripheral side so that the inner peripheral side of the curved slit 28 opens inward. When the pressure difference between the lumen 12 of the catheter main body 14 and the outside disappears, the inner peripheral side of the curved slit 28 constituting the flap valve 30 is restored to its original shape by elasticity and is closely attached to the outer peripheral side, so that communication for suction is performed. The hole 22 is blocked.

  Accordingly, for example, when supplying a drug solution to a patient's vein using the valve catheter 10 having such a structure, first, the distal end of the valve catheter 10 is inserted into the vein from the distal end side through the incision site of the patient. The part is positioned at the chemical supply site. The valve catheter 10 may be inserted into the vein by inserting a guide wire into the lumen 12 or without using the guide wire.

  Then, a syringe, a drug solution pack, or the like is connected to the proximal end side of the valved catheter 10 with the distal end inserted into the patient's vein. A large positive pressure chemical is introduced into the lumen 12. As a result, the drug solution can be supplied from the lumen 12 into the vein through the infusion communication hole 20 in which the slit valve 26 formed at the distal end portion of the catheter 10 with the valve is opened to be in communication.

  At this time, the positive pressure of the lumen 12 is also exerted on the flap valve 30, but the flap valve 30 has a curved shape in addition to being prevented from projecting outwardly by its curved peripheral wall shape. The slit 28 is an inclined cut surface, and the outer peripheral end surface of the flap valve 30 is overlapped with the inner peripheral surface of the catheter body 14, and the outer surface of the flap valve 30 is formed by this overlapping surface (outward deformation limiting means). Deformation is prevented. Therefore, problems such as venous damage and reduced operability of the procedure due to the flap valve 30 projecting outward and being caught on the inner surface of the vein are prevented.

  On the other hand, in order to collect blood or confirm reverse blood in a state where the catheter with valve 10 is inserted into a patient's vein, an injector is connected to the proximal end side of the catheter with valve 10 and a plunger is pulled. Negative pressure is applied to the cavity 12. As a result, blood can flow into the lumen 12 through the suction communication hole 22 that is opened and the flap valve 30 formed at the distal end portion of the valved catheter 10 is opened.

  That is, the negative pressure in the lumen 12 is also exerted on the slit valve 26, but because of the structure of the slit valve 26, both sides of the linear slit 24 are pressed against each other by the cut surface due to the negative pressure action of the lumen 12. The valve 26 is difficult to open. However, since the flap valve 30 is easily elastically deformed inward, blood collection through the suction communication hole 22 and confirmation of reverse blood can be easily performed.

  Moreover, since the flap valve 30 is elastically deformed in a direction protruding toward the inner peripheral side of the lumen 12, the flap valve 30 is not caught on the inner surface of the vein.

  As described above, in the valved catheter 10 of the present embodiment, injection of a chemical solution or the like through the injection communication hole 20 and suction of blood or the like through the suction communication hole 22 are both easily and stably performed. Therefore, it is possible to increase the hardness of the catheter body 14 while sufficiently securing the functions of injection and suction.

  Specifically, a material having a Shore A hardness of 70 to 100, preferably 80 to 90, can be employed as the catheter body 14, thereby further improving the operability of the procedure in the catheter. . In short, even when a material with high hardness is adopted, the switching operation between the slit state 26 and the flap valve 30 in the catheter body 14 between the communication state and the shut-off state is stably performed.

  The slit valve 26 and the flap valve 30 are preferably maintained in a closed state in the range where the relative pressure of the lumen 12 with respect to the outside is in the range of +7 mmHg to −80 mmHg. It is preferably opened when a negative pressure of 200 mmHg is applied, and more preferably opened when a negative pressure of -100 mmHg is applied. The slit valve 26 is preferably opened when a positive pressure of +10 mmHg is applied, and more preferably opened when a positive pressure is applied exceeding +7 mmHg.

  As mentioned above, although embodiment of this invention has been explained in full detail, this invention is not limited by the specific description of this embodiment. For example, a plurality of slit valves 26 and flap valves 30 can be provided on the catheter body 14. In addition, the slit valve 26 and the flap valve 30 can be formed at different positions in the tube axis direction of the catheter main body 14, or can be formed on the same side in the circumferential direction, and their formation positions are limited. Not a thing. Furthermore, the linear slit 24 forming the slit valve 26 and the curved slit 28 forming the flap valve 30 can be formed to extend in a direction inclined with respect to the tube axis direction.

  In addition, a contrast agent can be blended in the peripheral wall of the catheter body 14, and the contrast agent can be blended in an appropriate size and in an appropriate size, for example, a contrast agent can be blended only in a half circumference portion in the circumferential direction. A region can be provided.

  Furthermore, the present invention can also be applied to a double-lumen structure or multi-lumen valve-equipped catheter in which a plurality of lumens extending in the tube axis direction are formed inside the catheter body 14. In that case, it is not necessary to provide both the injection communication hole 20 and the suction communication hole 22 in the peripheral wall portions of all the lumens. For example, the injection communication hole 20 and the suction communication hole 22 may be formed on the peripheral walls of the different lumens, or the injection communication holes 20 may be formed on the peripheral walls of all the lumens. It is also possible to form the suction communication hole 22 only in the lumen.

10: catheter with valve, 12: lumen, 20: communication hole for injection, 22: communication hole for suction, 24: linear slit, 26: slit valve, 28: curved slit, 30: flap valve

Claims (3)

A catheter with a valve in which a communication hole provided with a valve body is provided in a peripheral wall portion of a flexible catheter whose tip is closed,
The communication hole for injection provided with the slit valve as the valve body that is opened by the action of positive pressure on the lumen of the catheter is formed by a linear slit formed in a peripheral wall portion away from the distal end of the catheter. And
With the curved slit formed in the peripheral wall portion of the catheter, the communication hole for suction provided with a flap valve as the valve body that is opened by the action of negative pressure on the lumen of the catheter is formed ,
An outward deformation limiting means for limiting the protrusion deformation of the flap valve to the catheter outer peripheral side is provided,
That any closed state is maintained in the range relative pressure with respect to outside of the lumen of at least + 7mmHg~-80mmHg of the catheter and the slit valve wherein the flap valve, valved catheter according to claim.   The valve catheter according to claim 1, wherein the catheter is made of a material having a Shore A hardness of 70 to 100.   The valved device according to claim 1 or 2, wherein the catheter is provided with a single lumen, and the slit valve and the flap valve are provided on opposite sides of the central axis of the catheter. catheter.

Images