JP4262733B2 - Medical balloon catheter - Google Patents

Description

  The present invention relates to a medical balloon catheter, and more particularly, is inserted into a body lumen such as a blood vessel, and the opening of the inserted body lumen is closed with an adsorbing member and fixed with a balloon inflated into the body lumen. The present invention relates to a medical balloon catheter.

  Coronary sinus (Coronary Sinus) in the right atrium as a technique for protecting the myocardium when the heart is stopped when performing open heart surgery such as coronary artery bypass surgery and valve replacement (replacement with a prosthetic heart valve) : CS) A retrograde perfusion is performed in which a balloon catheter is inserted into the opening and the balloon is inflated and placed and fixed, and then the myocardial protective solution is circulated throughout the heart while injecting the myocardial protective solution from the balloon catheter (for example, , See Patent Document 1).

  That is, as shown in FIG. 5A, after the balloon catheter 51 is inserted into the coronary sinus CS from the opening HCS in the inner wall H of the atrium, it is sterilized from the connector 57A provided at the rear end of the catheter body 52. Distilled water is injected to inflate the balloon 53 and fix it in the coronary sinus CS. Thereafter, the surgery is performed while the myocardial protective solution is perfused from the connector 57B.

Japanese Patent Laid-Open No. 06-063148

  However, the conventional balloon catheter 51 described above is provided with a rib 60 for increasing the contact frictional resistance with the inner wall of the coronary sinus CS on the outer surface of the balloon 53 provided in the vicinity of the distal end of the catheter body 52, and compared with a catheter without a rib. Although the fixing force is improved, there is a problem that the catheter is pulled out when an unexpected force is applied, and a catheter capable of obtaining a stronger fixing force has been desired.

  In view of the above problems, attempts have been made to enlarge the balloon to obtain a sufficient fixing force. That is, as shown in FIG. 5B, when the balloon 53A is made larger than the balloon 53, the small heart vein (Small Cardiac Vein :) is located near the opening HCS of the coronary sinus CS. SCV) is blocked, and the perfusion of blood flow and myocardial protective solution is blocked, so that the protective solution is not perfused into the myocardium governed by the blood vessel. In FIG. 5 (b), the hatched portion indicates the portion of the small cardiac vein SCV including the blocked opening and where the blood flow is blocked. In the figure, the opening of the Middle Cardiac Vein (MCV) is not blocked by the balloon 53A. However, if the size of the balloon used or the insertion depth of the catheter is too deep, the middle heart In rare cases, the opening of the venous MCV is also blocked.

Therefore this invention, the blood of the problems solved with the conventional balloon catheters, and sufficient fixing force with respect to the coronary sinus as a body lumen, the vessel which is located near the opening of the coronary sinus An object of the present invention is to provide a medical balloon catheter that can ensure both flow and flow.

In order to solve the above-mentioned problem, the invention according to claim 1 is characterized in that the heart of the heart in which the coronary sinus is formed from the inner wall of the right atrium and the small heart vein or the middle heart vein is formed at a depth of a predetermined length from the opening. A myocardial protective fluid inserted from the inner wall of the right atrium toward the opening of the coronary sinus and occluding the opening is circulated from the coronary sinus to the small heart vein or the middle heart vein in the retrograde direction throughout the heart. In a medical balloon catheter used for open heart surgery such as valve replacement or coronary artery bypass surgery , the catheter has a tubular catheter body and a balloon provided on the outer peripheral side of the distal end side of the catheter body, at least liquid injection lumen as the lumen, the balloon lumen, and aspiration lumen is formed, the balloon, so as not to occlude the small cardiac vein or the middle cardiac vein Is inserted from the serial opening in the coronary sinus, is configured to expand to a size is fixed is detained is, the outer peripheral surface after the balloon end of the catheter body, a flexible and elastically deformable In a state where no external force is applied, a substantially conical suction cup that extends outward from the opening of the coronary sinus is coronal so that the balloon does not block the small heart vein or the middle heart vein. When placed in the venous sinus and fixed, the peripheral edge of the catheter body is provided around the opening so as to close the opening, and the catheter body between the balloon and the suction cup. Includes a side hole that constitutes a decompression means for creating a negative pressure in a closed space formed between the suction cup and the inflated balloon, and the suction cup is connected to the suction lumen. Closing by means In a state of negative pressure imparting space, is deformed by negative pressure, a portion other than the peripheral portion, characterized in that it is configured to contact the periphery of the opening.

According to the second aspect of the present invention, the coronary sinus is formed from the inner wall of the right atrium of the heart in which the coronary sinus is formed from the inner wall of the right atrium and the small heart vein or the middle heart vein is formed at a depth of a predetermined length from the opening. Valve replacement or coronary artery bypass surgery in which the myocardial protective fluid that is inserted toward the opening of the heart is circulated in a retrograde direction throughout the heart from the coronary sinus to the small or middle heart vein A medical balloon catheter used for open heart surgery such as a tubular catheter main body and a balloon provided on the outer peripheral side surface on the distal end side of the catheter main body, the catheter main body having at least a drug solution injection lumen as a lumen balloon lumen and aspiration lumen is formed, the balloon, coronary sinus from the opening so as not to occlude the small cardiac vein or the middle cardiac vein Is inserted, is configured to expand to a size that is fixedly placed on the outer side surface of the side after the balloon of the catheter body, a flexible and elastically deformable is formed, an external force is applied Under the condition, a suction cup having a substantially conical shape extending outward from the opening of the coronary sinus is placed and fixed in the coronary sinus so that the balloon does not block the small heart vein or the middle heart vein. The periphery of the opening is provided so that its peripheral edge closely closes the opening, and is formed between the suction cup and the inflated balloon in the vicinity of the proximal end of the suction cup. One end of the auxiliary tube constituting the decompression means for making the closed space negative pressure open and connected to the closed space side, the other end of the auxiliary tube is connected in communication with the suction lumen, The suction cup A state of a negative pressure applied to the closed space by means being deformed by negative pressure, a portion other than the peripheral portion, characterized in that it is configured to contact the periphery of the opening.

The invention according to claim 3 is characterized in that, in claim 1 or 2, the suction lumen has a one-way valve for keeping the closed space in a negative pressure state. According to a fourth aspect of the present invention, in any one of the first to third aspects, the suction lumen has a safety valve for preventing excessive negative pressure in the closed space.

The present invention, since the a-described configuration, in addition to fixing by expansion force of the balloon, by utilizing the suction force of the negative pressure by the suction cup, a balloon catheter inserted into the coronary sinus as a body lumen since can be fixed to the coronary sinus, a balloon, or shall rib is not provided, it does not occlude the small cardiac vein or the middle cardiac vein of the tube branch is located near the opening of the coronary sinus size Even if the structure expands to a sufficient extent , a sufficient fixing force can be obtained by these balloons and suction cups . In other words, even if the balloon length in the length direction of the coronary sinus is shortened from the conventional length so as not to block the small heart vein or the middle heart vein , the fixing force that is insufficient by the shortened length of the balloon is absorbed by the suction cup . Since it can be compensated by force, it is possible to ensure both a sufficient fixing force and blood flow in the vicinity of the opening.

  An embodiment for carrying out the present invention will be described with reference to the drawings. FIG. 1 is a schematic front view showing an overall configuration of a balloon catheter according to an embodiment, and FIG. 2 is an enlarged cross-sectional view of the catheter body of the balloon catheter along the line AA ′ in FIG.

  1 and 2, reference numeral 1 denotes a balloon catheter having an outer diameter of 3 to 10 mm and an overall length of about 250 to 400 mm. The catheter body 2, a silicone rubber balloon 3 provided near the distal end of the catheter body 2, A suction cup 4 as an adsorbing member which is formed in a concave shape and is provided slightly on the proximal side of the balloon 3 of the catheter body 2 and a closed space 12 formed between the suction cup 4 and the inflated balloon 3 is predetermined. The suction lumen 5 which is a main member of decompression means such as a syringe and a suction pump (not shown) for reducing the negative pressure is mainly composed.

  The catheter body 2 is made of a material having a predetermined flexibility such as silicone rubber. As shown in FIG. 2, the catheter body 2 has a first lumen 6A for inflating and deflating a balloon, and injection of a drug solution or the like. A second lumen (main lumen) 6B for use and a third lumen 6C for measuring the pressure in the coronary sinus CS are formed, and a closed space 12 separate from these first to third lumens is formed. A suction lumen 5 is formed for the negative pressure operation. In this embodiment, the cross-sectional area of each of the first to third lumens 6A to 6C and the suction lumen 5 as the flow path is the largest for the second lumen 6B for injecting a chemical solution, and occupies substantially half of the whole. The first lumen 6A and the suction lumen 5 for the remaining balloon 3 are substantially the same, and the third lumen 6C for pressure measurement is slightly wider than these lumens 6A, 5, but these widths are merely examples. Therefore, it can be appropriately changed upon implementation.

  The balloon 3 is configured to expand to a size that does not occlude the small cardiac vein SCV (tube branching portion) in the coronary sinus CS located near the opening HCS. When the balloon 3 is inflated, the balloon 3 bulges outward over a predetermined range in the longitudinal direction around the catheter body 2, while in a contracted state, the balloon 3 has a flat shape along the outer peripheral surface of the catheter body 2. . Such a balloon 3 is provided in a predetermined range in the longitudinal direction from this location with reference to a location corresponding to the opening HCS of the coronary sinus CS in the catheter body 2. That is, the balloon 3 is configured to expand almost uniformly outward from the vicinity of the opening HCS of the coronary sinus CS over the entire range within a range shorter than the conventional one. The small cardiac vein SCV in the vicinity of the opening HCS of the sinus CS expands so as not to be occluded.

  The balloon 3 is connected to the inside of the balloon 3 in communication with one end of the first lumen 6 </ b> A, and the other end of the first lumen 6 </ b> A branches from the catheter body 2 on the proximal end side of the catheter body 2. The first connector 8A is connected to the open end of the first auxiliary tube 7A.

  The first connector 8A has a connector connection port having a predetermined shape at the end to which the first auxiliary tube 7A is not connected, and a syringe or the like (not shown) is connected to the connector connection port, and sterilization distillation is performed from the syringe. The balloon 3 can be inflated by supplying a fluid such as water. In addition, the first connector 8A may be a one-way valve having an appropriate configuration that prevents the backflow of the fluid supplied to the first auxiliary tube 7A.

  Therefore, the deflated balloon 3 is in close contact with the outer peripheral surface of the catheter main body 2, and the balloon 3 does not get caught in the opening HCS of the coronary sinus CS or the inner wall of the coronary sinus CS. It can be smoothly inserted into the coronary sinus CS. After the catheter body 2 is inserted, fluid such as sterilized distilled water is supplied into the balloon 3 via the first connector 8A and the first auxiliary tube 7A on the proximal side of the catheter. Can be inflated. That is, the balloon 3 can be arbitrarily inflated or deflated by appropriately injecting or discharging the inflation fluid into the balloon 3 via the first connector 8A and the first auxiliary tube 7A.

  In the catheter body 2, the area where the balloon 3 is provided may be formed into a thin diameter reduced by the thickness of the balloon member when not inflated. According to this structure, the catheter body 2 and the balloon 3 are formed. Therefore, the catheter body 2 can be more smoothly inserted into the coronary sinus CS.

  At least one side hole 2a is formed as an injection hole for a drug solution or the like on the outer peripheral side surface between the distal end opening 2b and the balloon 3 in the catheter body 2, and this side hole 2a communicates with the second lumen 6B. The other end of the second lumen 6B is a second auxiliary tube 7B extending from the catheter body 2, and a connector (not shown) is connected to the open end of the second auxiliary tube 7B. ing. Accordingly, the container and instrument for injecting the chemical liquid can be easily attached to and detached from the connector, and when the chemical liquid is injected into the connector, the second auxiliary tuft 7B and the second lumen 6B are sequentially connected from the connector. As a result, the drug solution or the like can be released from the side hole 2a and the opening 2b located on the distal end side of the balloon 3 of the catheter body 2.

  In addition to the opening 2b of the second lumen 6B, an opening 2c of the third lumen 6C is formed at the forefront of the catheter body 2, and the other end of the third lumen 6C is the base of the catheter body 2. A third auxiliary tube 7C branched from the catheter body 2 is connected on the end side, and a third connector 8C is connected to the open end of the third auxiliary tube 7C. Therefore, when the balloon catheter 1 is inserted into the coronary sinus CS and fixed, the flow path from the opening 2c to the inside of the third connector 8C is filled with a fluid such as sterilized distilled water. A pressure measurement circuit or sensor is connected to the 3 connector 8C, and the pressure fluctuation transmitted to the third connector 8C through the third lumen 6C and the third auxiliary tube 7C sequentially from the opening 2c can be measured. I have to.

  The suction cup 4 has a predetermined distance from the balloon 3 so that the peripheral edge of the suction cup 4 comes into contact with the periphery of the opening HCS when the catheter body 2 is inserted from the opening HCS of the coronary sinus CS by a predetermined length. It is provided in the predetermined part above.

  That is, the suction cup 4 monotonously spreads outward from the outer peripheral surface of a predetermined portion of the catheter body 2 toward the distal end in a state where no external force is applied, such as a predetermined concave shape such as an umbrella shape. It is formed in a conical shape that is a shape, and a peripheral portion of a shape that is larger than the opening HCS of the coronary sinus CS and spreads in a circular shape is secured. Further, the suction cup 4 is formed using a thin film silicone rubber or the like so as to be flexible and elastically deformable, and its peripheral edge is in contact with the flat surface around the opening HCS to form a sealed space inside the suction cup 4. When the closed space 12 is formed between the suction cup 4 and the flat surface, ventilation of the suction cup 4 itself is prevented so that the sealed space can be kept airtight. The material of the suction cup 4 is not limited to silicone rubber, but can be selected as appropriate as long as it is a soft material that can be folded freely, such as polyurethane, polyethylene, and other materials used in medical devices.

  A closed space 12 formed when the balloon catheter 1 is inserted into the coronary sinus CS to a predetermined depth on the outer peripheral side surface between the balloon 3 and the suction cup 4 in the catheter body 2 and the balloon 3 is inflated. A side hole 5b communicating with the suction lumen 5 for making the inside negative pressure is opened. The other end of the suction lumen 5 is a fourth auxiliary tube 9 extending from the catheter body, and a fourth connector 10 is connected to the open end of the fourth auxiliary tube 9.

  As with the first connector 8A, the fourth connector 10 has a connector connection port having a predetermined shape at its end, and this connector connection port is for applying negative pressure that constitutes decompression means such as a syringe or a suction pump (not shown). The connection port of the suction device can be easily attached and detached. Further, the fourth connector 10 has one of appropriate configurations that keeps the negative pressure in the suction lumen 5 and the closed space 12 by preventing air from flowing in from the outside, at least when the suction device is inadvertently removed. When a suction pressure exceeding a predetermined pressure, that is, an excessive negative pressure is supplied from the suction device, at least the excessive negative pressure is supplied to the inside of the suction lumen 5 and the closed space 12. A safety valve (not shown) having an appropriate configuration for preventing excessive negative pressure that escapes to the outside of the connector without being provided inside may be provided.

  That is, for example, in the middle of the first flow path from the suction lumen 5 formed in the fourth connector 10 to the connector connection port, the one-way valve described above is installed, and the one-way valve is bypassed. A second flow path communicating with the front and rear locations on the first flow path is formed, and a safety valve connected to an open path that escapes to the outside of the connector is installed in the middle of the second flow path. The safety valve closes the second flow path and the open path below a predetermined negative pressure, while at least the suction lumen 5 and the closed space 12 are in a negative pressure state exceeding the predetermined negative pressure, that is, When suctioned from the connector connection port so as to exceed the predetermined negative pressure, the safety valve is connected to the open channel from the connector connection port to the safety valve on the second channel through the first channel. Thus, a path for releasing the suction pressure to the outside of the connector is formed.

  The predetermined pressure set in advance in the safety valve is appropriately set to a value corresponding to the internal part of the subject where the balloon catheter 1 is used, the state of the part, and the like. That is, the safety valve is configured so that a negative pressure equal to or lower than a set value acts on at least the surface of the body part located in the suction cup 4, and the negative pressure set value includes the surface and tissue in the vicinity of the surface. A value that does not affect the value is set.

  Further, although not particularly illustrated, the peripheral edge that is the tip of the suction side of the suction cup 4 has a ring-shaped portion on the inner peripheral side from the peripheral edge formed in a thick rib shape, that is, regardless of some external force, that is, the peripheral edge Even if the other parts are deformed by negative pressure, the greatly expanded opening shape is maintained. Therefore, when the suction cup 4 is deformed by the negative pressure, the peripheral edge of the suction cup 4 starting from the peripheral edge and facing toward the center comes into contact with the periphery of the opening HCS. On the other hand, when a negative pressure that does not deform is applied to the suction cup 4, only the peripheral edge of the rib is physically in contact with the periphery of the opening HCS. The contact area of the peripheral portion is secured so that the pressure does not affect the surface around the opening HCS and the tissue in the vicinity of the surface.

  Next, the balloon catheter 1 configured as described above will be described in more detail. First, as shown in FIGS. 3A and 3B, the balloon catheter 1 is inserted until the peripheral portion of the suction cup 4 contacts the inner wall H of the atrium around the coronary sinus CS. At this time, since the positions and sizes of the balloon 3 and the suction cup 4 from the tip of the balloon catheter 1 are determined from anatomical data, the balloon catheter 1 reaches a position where the balloon 3 blocks the small cardiac vein SCV. It is also a mark to prevent the insertion.

  Then, a negative pressure is applied from the suction lumen 5 to the suction cup 4 located in the coronary sinus CS. Since the coronary sinus CS has already been occluded by the balloon 3 on the side of the Great Cardiac Vein (GCV), the suction cup 4 is brought into close contact with the periphery of the coronary sinus CS by negative pressure, and the position changes during surgery. The departure of the balloon 3, that is, the drop off of the balloon catheter 1 can be prevented. That is, the peripheral edge of the suction cup 4 is in contact with the inner wall H of the atrium around the opening HCS of the coronary sinus CS, and the closed space 12 formed between the suction cup 4 and the inflated balloon 3 is set to a negative pressure. Therefore, a predetermined amount of air in the closed space 12 is discharged through the suction lumen 5.

  When the balloon catheter 1 is mounted on the coronary sinus CS in this way, in addition to the first fixing force due to the expansion of the balloon 3 in the sinus, the suction cup 4 to which a negative pressure is applied as the second fixing force. Since the adsorption force can be obtained, the balloon catheter 1 can be securely and stably fixed to the coronary sinus CS even if the contact area of the balloon 3 in the longitudinal direction in the coronary sinus CS is reduced as compared with the conventional case. Can do. That is, the balloon catheter 1 can be secured to the coronary sinus CS with sufficient reliability without blocking the perfusion of the myocardial protective fluid to the blood vessel opening near the opening HCS of the coronary sinus CS. .

  After the balloon catheter 1 is fixed, the myocardial protective fluid is perfused from the second lumen 6B provided in the balloon catheter 1 as appropriate. The change in perfusion pressure at this time is changed from the distal end opening 2c to the third lumen. Since it is transmitted to the pressure measuring device (not shown) via the 6C and the third auxiliary tube 7C, the myocardial protective fluid can be perfused while maintaining an appropriate perfusion pressure.

  Further, when the balloon catheter 1 is removed, the fixation is released and the balloon catheter 1 is detached from the coronary sinus CS in the reverse procedure to that when the catheter is mounted. That is, the negative pressure in the closed space 12 that is a source of one fixing force is released to reduce the suction force of the suction cup 4, and the balloon 3 pressure that is the source of the other fixing force is released to release the balloon 3 Shrink. In other words, the one valve that is arranged in the fourth connector 10 and holds the inside of the closed space 12 at a negative pressure is operated to release the negative pressure, and then the negative pressure is released, and then the balloon 3 is held at a high pressure by being arranged in the first connector 8A. The one-way valve is opened to release the balloon pressure.

  As described above, according to this embodiment, the suction cup 4 that can be adsorbed around the opening HCS of the coronary sinus CS is newly added to the catheter body 2, and in addition to the balloon 3, the suction cup 4 Is used to secure the balloon catheter 1 inserted into the coronary sinus CS, so that sufficient securing force and blood flow in the vicinity of the opening HCS can be ensured at the same time. That is, the balloon 3 is inflated to a size that does not block the opening of the small cardiac vein SCV in order to secure the blood flow of the small cardiac vein SCV, which is a tube branch portion in the coronary sinus CS located near the opening HCS. Thus, even if the length of the balloon 3 in the longitudinal direction of the coronary sinus CS is shortened, at least the fixing force that is insufficient by the shortening of the balloon 3 can be supplemented by the suction force by the suction cup 4. Accordingly, the blood flow in the vicinity of the opening HCS can be secured and the balloon catheter 1 can be prevented from dropping during the operation, so that the stress of the practitioner can be reduced and the condition of the patient during the operation can be stabilized.

  Further, since the suction cup 4 is adsorbed around the opening HCS of the coronary sinus CS into which the balloon catheter 1 is inserted, it can be avoided that the suction cup 4 becomes an obstacle to other surgical instruments and their operation. That is, when viewed from the periphery of the balloon catheter 1 and from the coronary sinus CS side, the suction cup 4 is located at the base portion of the catheter body 2 protruding from the coronary sinus CS, so that it does not become an obstruction.

  In particular, since the amount of fixing force required to fix the balloon catheter 1 to the body part is constant, in this embodiment, a member that contacts the body part to be fixed is used as the balloon catheter 1 as the balloon 3. Since the two members of the suction cup 4 and the suction cup 4 are used, the magnitude of the fixing force that each member is responsible for can be smaller than that of the structure of the balloon alone, and the burden on each member itself can be reduced. The load on the coronary sinus CS is not concentrated on one place in the coronary sinus CS, but is distributed in the coronary sinus CS and around the opening HCS in the coronary sinus CS. Can be reduced. For this reason, it is not necessary to press the tissue in the coronary sinus CS to which the balloon 3 is in close contact, and it is possible to avoid the necrosis of the tissue.

  On the other hand, when the balloon catheter 1 is fixed to the coronary sinus CS by cooperating the balloon 3 and the suction cup 4 as described above, the catheter body 2 inserted into the coronary sinus on the center line of the coronary sinus CS. It is possible to fix the center line of the front end portion in a substantially matched state. That is, the balloon 3 inflated in the coronary sinus CS not only holds the catheter body 2 at one point on the length direction in the coronary sinus and on the substantially center line in the coronary sinus, Since the suction cup 4 is adsorbed around the opening HCS which is a plane substantially perpendicular to the length direction of the sinus CS, the suction cup 4 can be positioned in the substantially orthogonal direction as a second point, and the coronary sinus The posture in which the tube length direction of the balloon catheter 1 is aligned with the direction of the CS is more stably maintained. For this reason, since the accuracy of the position occupied in the coronary sinus CS of each hole provided at the distal end of the balloon 3 in the catheter body 2 can be sufficiently ensured, the drug solution enters the coronary sinus CS via each hole. Can be reliably and highly accurately measured.

  Further, as described above, as a means for reducing the pressure of the closed space 12, the suction lumen 5 preferably has the one-way valve described above, and more preferably has a safety valve for preventing excessive negative pressure. Furthermore, it is good also as a structure which integrated the inflow prevention function to the suction cup 4 by a one-way valve, and the excessive negative pressure prevention function by a safety valve in one adjustment valve. For example, this regulating valve is a three-way valve installed in the first flow path formed in the fourth connector 10 described above, and two of the valve passages are respectively connector connection ports of the first flow path. The remaining one valve passage is connected to the side and the suction cup side, and is connected to an open passage leading to the outside of the connector so as to prevent passage of air between the two valve passages from the open passage and to exceed a predetermined negative pressure. When sucked from the connector connection port, the remaining valve passage is opened so as to form a flow path from the connector connection port to the open path, and at least the blocking operation can be canceled by manual operation. I am doing so.

  In the above-described embodiment, the suction cup 4 is formed in a substantially conical shape. However, the shape and size of the suction cup itself are appropriately set according to the site and application of the use target without being limited thereto. , Can be changed. That is, for example, the suction cup 4 is formed in a flat dish shape while ensuring a large and wide circular peripheral edge and reducing the distance from the periphery of the opening HCS to the inner surface of the suction cup 4 facing the periphery of the opening. Thus, the suction cup 4 deformed by the negative pressure may be formed so that the inner surface thereof is more in surface contact with the periphery of the opening HCS. Therefore, in the case of the structure formed in this flat plate shape, since the annular contact surface starting from the peripheral portion becomes wide, a certain degree of unevenness existing on the peripheral side of the opening within the range of the contact surface is allowed. Thus, the airtightness in the suction cup 4 can be secured, the application range as the balloon catheter 1 can be expanded, and the posture of the balloon catheter 1 can be secured more stably. In particular, in the horizontal configuration in which such a wide annular contact surface is ensured, for example, a peripheral portion of a part of the peripheral portion from the periphery of the opening HCS is present, for example, when a surgical instrument other than the catheter is in contact. Even if it is turned up, the contact surface on the inner center side from the periphery can be maintained, and the suction cup 4 can be kept in an airtight state, that is, in a negative pressure state, so that the balloon catheter 1 can be stably and firmly lumened. Can be fixed to.

  Further, in the adsorption experiment using the prototype of this configuration, when only the balloon 3 is used, the balloon is formed from the test object in which an opening corresponding to the coronary sinus CS is formed with a force of about 0.98 N (100 gf). When the suction cup 4 is used in addition to the balloon 3 while the catheter 1 is disengaged, a negative pressure (−200 mmHg: large) of −26.7 kPa is generated in the experimental object corresponding to the closed space 12. An adsorption force of about 6N was measured when the pressure was changed from the atmospheric pressure.

  On the other hand, for example, in the case of a catheter that is inserted into a separated blood vessel or an artificial blood vessel to send blood, it is formed on a spindle-shaped sucker such as a tulip, and the volume of the internal space formed by the sucker itself is sufficient. You may make it secure to. Furthermore, the shape of the peripheral portion is not limited to a circular shape, and may be appropriately formed into an asymmetric shape such as an elliptical shape, a polygonal shape, or an irregular shape that changes more slowly.

  Further, as shown in FIG. 4, the opening 5 b of the suction lumen 5 is not opened on the outer peripheral side surface between the balloon 3 and the suction cup 4 of the catheter body 2 but in the vicinity of the proximal end side of the suction cup 4. Even when the auxiliary tube 13A is branched to communicate with the auxiliary tube 13A, and the other end of the auxiliary tube 13A is provided to communicate with the through hole 5d provided in the suction cup 4, the closed space 12 has a predetermined negative pressure. be able to. In addition, it is good also as a structure which uses the opening part 5b of the suction lumen 5 together.

  Furthermore, the closed space 12 formed with the peripheral edge of the suction cup 4 in contact with the periphery of the opening HCS can provide a space inside the coronary sinus CS if the suction force by the suction cup 4 set to a negative pressure is sufficiently obtained. It does not have to be included. In other words, the suction cup 4 may inflate the balloon 3 so as to close the opening HCS as long as the suction force sufficient to compensate for the fixing force insufficient with the balloon 3 alone can be secured. A part of the deformed suction cup 4 may come into contact with the balloon 3 with the opening HCS closed.

  In the balloon catheter 1, the balloon 3 mainly obtains the fixing force for the catheter mainly by blocking the coronary sinus CS, while the suction cup 4 mainly obtains the fixing force for the catheter by the adsorbing force. You may comprise as follows.

  Furthermore, the above embodiment is merely a preferable example, and the specific configurations of the catheter body 2, the balloon 3, the suction cup 4, and the like are variously changed within the scope described in the claims. It can be corrected.

Next, an effect peculiar to the invention described in claim 2 and subsequent claims will be described. According to the invention described in claim 2, in place of the side hole of the invention described in claim 1, a closed space formed between the suction cup and the inflated balloon is hidden in the vicinity of the proximal end side of the suction cup. The one end of the auxiliary tube constituting the pressure reducing means for making the pressure is opened and connected to the closed space side, and the other end of the auxiliary tube is connected in communication with the suction lumen. The same effect as that of the present invention can be expected.

According to the invention of claim 3, the suction lumen has a one-way valve that keeps the closed space in a negative pressure state. Therefore, after the closed space is once made into a negative pressure, an operation for keeping the negative pressure state, Use of an instrument for maintaining a negative pressure state can be eliminated. For this reason, the balloon catheter can be handled easily and easily.

According to the invention of claim 4, since the suction lumen has the safety valve for preventing the excessive negative pressure in the closed space, the operation of setting the negative pressure on the suction cup, that is, the operation of reducing the closed space is simplified. It is possible to prevent mistakes. For this reason, the suction cup can be easily and quickly decompressed while reducing the stress on the operator. As a result, the balloon catheter can be handled easily and easily.

It is a schematic front view which shows the whole structure of the balloon catheter which concerns on one embodiment of this invention. It is an expanded sectional view of the catheter main body of the balloon catheter which follows the AA 'line of FIG. The balloon catheter is used in the same manner, (a) is a cross-sectional view showing a state where the catheter is inserted into the coronary sinus and the balloon is inflated, and (b) is a predetermined shadow inside the adsorption member. It is sectional drawing which shows the general state which fixed the balloon catheter to the coronary sinus under pressure. It is a schematic front view which shows the whole structure of the balloon catheter which concerns on another form of this invention. The state of use of a conventional balloon catheter is shown, (a) is a cross-sectional view showing a state in which the balloon is inflated by inserting the catheter into the coronary sinus, and (b) is a cross-sectional view showing the catheter in the coronary sinus. It is sectional drawing which shows the state which inserted and expanded the big balloon compared with the balloon of (a).

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Balloon catheter 2 Catheter main body 2a Side hole (chemical solution injection hole) 2b Opening part (for chemical solutions)
2c Opening (for perfusion pressure measurement) 3 Balloon 4 Suction cup (adsorption member) 5 Suction lumen 6A First lumen (for balloon) 6B Second lumen (for drug solution)
6C 3rd lumen (for measurement) 7A 1st auxiliary tube (for balloon)
7B Second auxiliary tube (for chemicals) 7C Third auxiliary tube (for measurement)
8A 1st connector (for balloon) 8C 3rd connector (for measurement)
9 4th auxiliary tube (for suction cup) 10 4th connector (for suction cup)
CS Coronary sinus (body lumen) HCS Coronary sinus opening H Atrial inner wall GCV Large heart vein SCV Small heart vein

Claims (4)

The coronary sinus is inserted from the inner wall of the right atrium, and the small heart vein or the middle heart vein is formed on the back side by a predetermined length from the opening thereof, and is inserted from the right atrial inner wall of the heart toward the opening of the coronary sinus, Medical use for open heart surgery such as valve replacement or coronary artery bypass surgery in which the myocardial protective fluid to be injected with the opening closed is circulated in a retrograde direction from the coronary sinus to the small heart vein or the middle heart vein . In balloon catheters,
It has a tubular catheter body and a balloon provided on the outer peripheral side of the distal end side of the catheter body, and the catheter body has at least a drug solution injection lumen, a balloon lumen, and a suction lumen formed as a lumen. The balloon is configured to be inserted into the coronary sinus from the opening so as not to occlude the small heart vein or the middle heart vein, and is inflated to a size to be placed and fixed .
A substantially conical cone formed on the outer peripheral side of the catheter body rearward from the balloon so as to be flexible and elastically deformable and spread outwardly larger than the opening of the coronary sinus in a state where no external force is applied. When the shape of the suction cup is placed and fixed in the coronary sinus so that the balloon does not occlude the small heart vein or the middle heart vein, the peripheral edge closely contacts the periphery of the opening. Provided to occlude, and
On the outer peripheral side surface of the catheter main body between the balloon and the suction cup, a side hole constituting a decompression means for making a closed space formed between the suction cup and the inflated balloon a negative pressure is provided in the suction lumen. In communication with
The suction cup is configured to be deformed by negative pressure in a state where negative pressure is applied to the closed space by the pressure-reducing means, and a portion other than a peripheral edge thereof is configured to contact the periphery of the opening. A medical balloon catheter. The coronary sinus is inserted from the inner wall of the right atrium, and the small heart vein or the middle heart vein is formed on the back side by a predetermined length from the opening thereof, and is inserted from the right atrial inner wall of the heart toward the opening of the coronary sinus, Medical use for open heart surgery such as valve replacement or coronary artery bypass surgery in which the myocardial protective fluid to be injected with the opening closed is circulated in a retrograde direction from the coronary sinus to the small heart vein or the middle heart vein . In balloon catheters,
It has a tubular catheter body and a balloon provided on the outer peripheral side of the distal end side of the catheter body, and the catheter body has at least a drug solution injection lumen, a balloon lumen, and a suction lumen formed as a lumen. The balloon is configured to be inserted into the coronary sinus from the opening so as not to occlude the small heart vein or the middle heart vein, and is inflated to a size to be placed and fixed .
A substantially conical cone formed on the outer peripheral side of the catheter body rearward from the balloon so as to be flexible and elastically deformable and spread outwardly larger than the opening of the coronary sinus in a state where no external force is applied. When the shape of the suction cup is placed and fixed in the coronary sinus so that the balloon does not occlude the small heart vein or the middle heart vein, the peripheral edge closely contacts the periphery of the opening. Provided to occlude, and
Near one end of the suction cup , one end of an auxiliary tube that constitutes a decompression means for creating a negative pressure in the closed space formed between the suction cup and the inflated balloon is opened and connected to the closed space side. The other end of the auxiliary tube is connected in communication with the suction lumen;
The suction cup is configured to be deformed by negative pressure in a state where negative pressure is applied to the closed space by the pressure-reducing means, and a portion other than a peripheral edge thereof is configured to contact the periphery of the opening. A medical balloon catheter. The medical balloon catheter according to claim 1 or 2, wherein the suction lumen has a one-way valve that keeps the closed space in a negative pressure state. The medical balloon catheter according to any one of claims 1 to 3, wherein the suction lumen has a safety valve for preventing excessive negative pressure in the closed space.

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