JPH0938208A - Aortic balloon catheter with suction route for injection of cardiac muscle protecting fluid - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an aortic balloon catheter with suction route for injecting cardiac muscle protecting fluid which is useful for a prosthetic blood vessel replacing operation, by providing a balloon which becomes a prescribed dimension when expanding on a front part of a tube, having the first lumen for inserting core wire, the second lumen of a prescribed cross-sectional area, and the third lumen having side holes, and maintaining its shape. SOLUTION: An aortic balloon catheter with suction route for injecting cardiac muscle protecting fluid is formed by a flexible tube 1 and is attached air-tightly to the head part of the outer circumference of the flexible tube 1. A balloon 2 whose outer diameter is at least 35mm and outer diameter/length = 1.15/1∼2.50/1 is provided when the balloon catheter is expanded by injecting air or water of 40-60ml. And this aortic balloon catheter with suction route for injecting cardiac muscle protecting fluid is provided with a sealed head end opening part 25, an opening part 22 for communicating to lumen of the balloon 2, a balloon expanding lumen 13 in which the core wire 3 is inserted over whole length, an injection lumen 11 which is penetrated to the longitudinal direction and has a cross-sectional area of 1.5∼4.5mm<2> , and a suctional lumen 10 which is sealed at its head end, has cross-sectional area of 2.5∼6.5mm<2> and has side holes 24 backward of the balloon 2, thereby the shape can be maintained.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention mainly relates to a balloon catheter for occluding the aorta by inflating the balloon in the aorta during surgery for aortic aneurysm. For more information,
The present invention is particularly useful when performing an operation on the aneurysm occurring in the distal aortic arch consisting of the vicinity of the left subclavian artery and its peripheral region, especially by the left thoracotomy method and retrograde cerebral circulation (perfusion) method. Related to balloon catheters.

[0002]

2. Description of the Related Art As a surgical treatment for aortic arch aneurysms, aortic replacement with artificial blood vessels has been performed. In order to perform the operation of this operation accurately, it is necessary to stop the heart and block the blood flow in the aortic arch to obtain a bloodless surgical field. Therefore, in this operation, there are means for stopping the heart to maintain and restore the function of the myocardium, and means for performing blood circulation (perfusion) to the brain and body parts in place of the stopped heart. Will be needed. Cardiac arrest and cardioplegia are basically performed by perfusing a coronary artery with a drug solution containing a high-potassium solution called cardioplegic solution to perform rapid cardiac arrest, and at the same time cool the myocardium with ice etc. Realize by maintaining. Rapid cardiac arrest and low temperature maintenance can reduce myocardial oxygen consumption and retain energy for heartbeat. Cardioplegia is generally intermittent with an injection needle from the base of the aorta just below the block of the ascending aorta.
Or infuse continuously.

On the other hand, as a method for performing blood perfusion during surgery for aneurysm of the arch, conventionally, the extracorporeal cerebral circulation method has been used. In this method, cerebral circulation and systemic circulation are separated and performed separately, and cerebral perfusion is performed by a blood supply cannula inserted in the brachiocephalic artery and the left common carotid artery. Although this method has the advantage that surgery can be performed without being bound by time constraints, it requires work such as detachment or blockage of the arch branch branch associated with cannulation, which may cause dissection of the arch branch branch or arteriosclerosis. It has been pointed out that the risk is high in patients with strong illness, and that there is a possibility of new exfoliation due to manipulation and brain complications due to release of thrombus. In addition, there is a drawback that the operation field is complicated by the blood supply cannula.

On the other hand, in recent years, a retrograde cerebral circulation (perfusion) method has been popular in which central venous pressure is increased during cardiac arrest to retrograde cerebral circulation (perfusion) of blood from the superior vena cava to the aortic arch. Then, it came to be implemented. Since this method retrogradely supplies blood to the brain from the vena cava, there is no need for cannulation of the partial branch of the arch, and it has the advantage of avoiding the risks pointed out in the above-mentioned extracorporeal circulation method for the brain. This is also advantageous in terms of ensuring a good surgical field.

Furthermore, the use of the retrograde cerebral circulation (perfusion) method has made it possible to perform surgery with a left thoracotomy for a distal aortic aneurysm. Distal aortic aortic aneurysm is a relatively frequent disease among arch aortic aneurysms. Conventionally, blood circulation (perfusion) was performed by the extracorporeal cerebral circulation method, and the aneurysm was approached with a midline incision. However, this procedure was complicated, and the operation required more than 10 hours. However, when the retrograde cerebral circulation (perfusion) method and left thoracotomy were adopted for this case,
The operation time can be shortened to 5 to 6 hours. This is because this procedure can simplify the extracorporeal circulation means, does not require cannulation of the arch branch, and can reach the aneurysm more easily than the midline incision approach. This is because. Not surprisingly, the invasion of the patient is significantly less than conventional methods.

Retrograde cerebral circulation for distal arch aortic aneurysm
When approaching with left thoracotomy under (perfusion), it is difficult to block the ascending aorta and expose the base, unlike the case of a midline incision. Therefore, for injection of the cardioplegia solution, a balloon catheter having an injection lumen is inserted into the aortic root through the aneurysm opening, the balloon is inflated to occlude the ascending aorta, and the balloon catheter is injected through the injection lumen. ~ 500
A method of injecting a cardioplegic solution at a flow rate of ml / min. is adopted.

However, some disadvantages have been pointed out for this method. First, because the shaft of the balloon catheter is not strong enough, the balloon that has blocked the ascending aorta is pushed back by the delivery pressure generated when injecting the myocardial protection liquid, and the myocardial protection liquid cannot be efficiently injected. . Secondly, since the balloon catheter is too long when inflated, there is a risk that the balloon that has occluded the ascending aorta may be occluded by the partial arch branch.

Thirdly, in retrograde cerebral circulation (perfusion), blood circulates from the jugular vein through the brain and carotid artery to the aortic arch, so that blood flows from the brachiocephalic artery and the left common carotid artery to the operative field. Is to come out. The outflow of blood to the operative field significantly reduces and makes uncertain the workability of the replacement of the aneurysm with the artificial blood vessel, that is, the anastomosis between the distal aortic arch and the artificial blood vessel. Usually, in order to keep the operative field bloodless, the spilled blood was suctioned with a surgical tool called soccer to ensure the bloodless state of the operative field. However, since a catheter is inserted from the aneurysm incision to the ascending aorta, it cannot be said that there is enough room for inserting soccer. If soccer is inserted, the visibility of the anastomosis part is deteriorated and the work space for the anastomosis work of the artificial blood vessel is narrowed, so that the workability thereof is significantly reduced.

[0009]

[Problems to be Solved by the Invention] The retrograde cerebral circulation (perfusion) method for left aortic aortic aneurysm and the procedure of left thoracotomy simplifies the operation and shortens the time. The anastomosis of the artificial blood vessel has the above-mentioned problems, and the means for safely and surely performing this operation has not been certain. Therefore, the inventors have conducted diligent studies in order to solve these problems, in particular, an aneurysm occurring in the distal arch of the aorta, left artificial thoracotomy, retrograde cerebral circulation (perfusion) artificial blood vessel replacement We have arrived at the invention of a balloon catheter that is useful in performing surgery.

[0010]

The present invention comprises a flexible tube, which is hermetically attached to the outer circumference of the front portion of the tube and has a volume of at least 35 mm when inflated with 40 to 60 ml of air or water. Has an outer diameter of and outer diameter / length
= 1.15 / 1 to 2.50 / 1 provided with a balloon, the distal end is sealed, the first lumen has an opening communicating with the lumen of the balloon, and the cored bar is inserted over the entire length. And a second lumen having a cross-sectional area of 1.5 to 4.5 mm ² penetrating in the long axis direction, and the tip is sealed to 2.5
An aortic balloon catheter for injection of a cardioplegia solution with a suction route, which has a third lumen having a cross-sectional area of ˜6.5 mm ² and at least one side hole behind the balloon and is capable of retaining its shape Is provided.

[0011]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below in detail with reference to the drawings. FIG. 1-a is a diagram showing an outline of an embodiment of a catheter according to the present invention, and FIG. 1-b is a diagram showing a sectional shape taken along the line AA ′ in FIG. 1-a. 1-a
In the figure, a catheter tube 1 is made of a flexible tube having 3 lumens, a balloon 2 is airtightly attached to the outer circumference of the front part of the catheter tube 1, and the lumen of the balloon 2 and the lumen 9 for balloon inflation are It is connected by an opening 22. The balloon inflation lumen 13 has a tip end sealed with a sealing material and a rear end portion 21 connected to the connector tube 4. A one-way valve 9 is attached to the other end of the connector tube 4 so that a saline solution can be injected into the balloon 2 from a syringe connected thereto through the balloon inflation lumen 13.

The outer diameter of the balloon when inflated by injecting 40 to 60 ml of air or water is at least 35 mm, and the outer diameter / length of the balloon at this time = 1.15 / 1 to
It should be 2.50 / 1. When the outer diameter of the balloon 2 when inflated is 35 mm or less, it is not preferable because the ascending aorta cannot be occluded. If the outer diameter / length of the balloon 2 is smaller than 1.15 / 1, the balloon length becomes long,
It is not preferable because it may block the arch branch when it expands in the ascending aorta. Conversely, the outer diameter of the balloon 2 /
If the length is larger than 2.50 / 1, when the balloon 2 is inflated to occlude the ascending aorta, the contact area of the balloon 2 with the blood vessel wall of the ascending aorta is significantly reduced, and reliable obstruction cannot be achieved, which is not preferable. .

In the present invention, in order to secure the fixation in the ascending aorta of the balloon 2 when injecting the cardioplegic solution, the outer surface of the balloon 2 is provided with rib-like or mesh-like unevenness and slips. It may be stopped. The material of the balloon used in the present invention is not particularly limited, but a flexible material is preferable from the viewpoint of adhesion to the blood vessel wall, and among them, latex, styrene-butadiene copolymer, silicone rubber, polyurethane and these. A copolymer of
A polyolefin elastomer and a polyolefin-based polymer alloy are preferable. Also, a laminated product of these or a product reinforced with a mesh or the like can be used.

The core metal 3 is arranged in the balloon inflation lumen 13 over the entire length of the catheter tube 1 and is fixed at the front end portion 20 and the rear end portion 21. The strength of the catheter shaft is maintained by the core metal 3, and the balloon that has occluded the ascending aorta is not pushed back by the delivery pressure when the cardioplegic solution is injected. It is also possible to bend the catheter freely and maintain its shape. The core metal used in the present invention preferably has a diameter of 0.5 to 1.5 mm, and examples thereof include stainless steel wires, pipes, wires, spring coils, and composites thereof. .

The injection lumen 10 is opened forward of the balloon 2 at the tip opening 25 and is connected to the injection tube 6 at the rear end 21. The other end of the injection tube 6 has a connector 8
Is attached. By connecting a cardioplegia solution injection circuit to the connector 8, it is possible to inject the cardioplegia solution into the ascending aorta from the tip opening 25 through the injection lumen 11. The suction lumen 10 has a tip sealed with a sealing material and a suction tube 5 at the rear end 21.
Connected to At least one side hole 24 is provided in the tube wall surface of the catheter tube 1 behind the balloon 2 and communicates with the suction lumen 10. By connecting the other end of the suction tube 5 to a blood suction circuit, blood flowing out from the brachiocephalic artery and the left common carotid artery to the operative field by the retrograde cerebral circulation (perfusion) is suctioned from the side hole 24, and It is possible to maintain a bloodless state.

The hardness of the material of the catheter tube 1 used in the present invention is Shore 80A to 65D, preferably Shore 85A to 60D. If the hardness is softer than Shore 80A, when negative pressure is applied to the suction lumen 10,
It is not preferable because the lumen is crushed and suction cannot be performed. If the hardness is harder than the Shore 65D, when the user of the catheter bends the catheter tube 1, the catheter tube 1 is bent and the lumen is blocked, which is not preferable.

In the present invention, the material of the catheter tube 1 is not particularly limited, and for example, polyvinyl chloride resin, silicone resin, polyurethane resin, polyamide resin, polyolefin resin, their copolymers and polymer alloys can be used. If necessary, the anti-thrombotic property may be imparted by coating the heparinized material disclosed in Japanese Patent Publication No. 7-44950. The outer diameter of the catheter tube 1 is 3.5 to 7.0 mm, preferably 4.5 to 6.0 mm, and the outer wall thickness of the catheter tube 1 at this time is 0.
4 to 0.9 mm, preferably 0.45 to 0.75 mm, and the thickness of the septum of each lumen is 0.15 to 0.8 mm, preferably 0.1.
It is 3 to 0.7 mm.

If the outer diameter is smaller than 3.5 mm, it is not preferable because the size of each inner cavity cannot be sufficiently ensured even if the outer peripheral wall thickness and the partition wall thickness are minimized. In addition, if the thickness of the outer circumference of the tube is less than 0.4 mm to ensure the size of each lumen, the catheter tube 1 will be easily bent, and if the thickness of the partition of each lumen is less than 0.15 mm, it will be sufficient for the partition. Strength is not obtained, and an opening may occur between the lumens during use of the catheter. On the other hand, if the diameter is larger than 7.0 mm, the catheter becomes too thick, which hinders the operative field and the working space for the anastomosis of the artificial blood vessel becomes insufficient, which is not preferable. Further, if the wall thickness of the outer circumference of the tube is larger than 0.9 mm, or if the thickness of the partition wall is larger than 0.8 mm, it is not preferable because the size of each lumen cannot be secured sufficiently.

In the present invention, the thickness of the catheter tube 1, the outer circumference of the tube and the thickness of the partition wall as well as the size of each lumen for maintaining the function of the catheter are defined as described above. The injection lumen 11 must ensure a cross-sectional area of 1.5-4.5 mm ² . 2 injections of cardioplegia
0 to 500 ml / min. Is required and the cross-sectional area is 1.5 mm ²
If the cross-sectional area is 4.5 mm ² or more, it is not preferable since the pressure loss becomes large and a sufficient injection amount cannot be secured below, and
Although it is possible to secure a sufficient injection amount, it is not preferable to secure a sufficient size for other lumens to function under the restriction of a catheter tube having a diameter of 7 mm or less.

Further, according to the present invention, a suction lumen
10 must secure a cross-sectional area of 2.5 to 6.5 mm ² . Suction capacity of blood spilled into the operative field is 50 to 1
00 ml / min. Is required, and if the cross-sectional area is 2.5 mm ² or less, not only a sufficient suction amount can be secured, but also blood clots,
Alternatively, since the side hole 24 and the suction lumen 10 are closed when the surgical site tissue is sucked, it is not preferable, and if the cross-sectional area is 6.5 mm ² or more, a sufficient suction amount can be secured. Under the limitation of a catheter tube having a diameter of 7 mm or less, it is not preferable because it is not possible to secure a size for other lumens to function sufficiently.

The cross-sectional area of the balloon inflation lumen 13 is arbitrarily set depending on the prescribed outer diameter, the required blood suction amount, and the myocardial protective fluid flow rate, but is 2.5 to 6.5 mm ^2.
It is preferable to secure the cross-sectional area of The flow passage cross-sectional area of these lumens may be adjusted depending on the application of the catheter. For example, when the suction capacity of blood is set to the maximum with a catheter having a diameter of 5.5 mm, the suction lumen 10 has 6.
Secure a cross-sectional area of 5 mm ² and make the other lumen sizes 2.
Set to 5 mm ² . In this case, the thickness of the outer circumference of the tube is 0.
The thickness of the partition wall is 6 mm and the thickness of the partition wall is 0.3 mm.

[0022]

As described above, the aortic balloon catheter for injecting a myocardial protective solution with a suction route according to the present invention has a balloon having an optimal shape for occluding the ascending aorta, and provides necessary and sufficient myocardial protection. It has a fluid injection function and a blood suction function, and the balloon is not pushed back due to the delivery pressure generated by the injection at the time of injecting the cardioplegia solution, and especially the left thoracotomy method for the distal arch aortic aneurysm, It is suitable as a device that enables safe and reliable operation by the retrograde cerebral circulation (perfusion) method.

[Brief description of drawings]

1 is a diagram showing an outline of an embodiment of a catheter according to the present invention, and FIG. 1-b is a line AA ′ in FIG. 1-a.
It is a figure which shows the cross-sectional shape in.

Claims (2)

[Claims] 1. A flexible tube, which is airtightly attached to the outer periphery of the front portion of the tube, has an outer diameter of at least 35 mm when inflated by injecting 40 to 60 ml of air or water, and Outer diameter / length = 1.15 / 1 to 2.50
/ 1 is provided, and the distal end is sealed and has an opening that communicates with the inner cavity of the balloon, and penetrates in the long axis direction with the first inner cavity in which the core metal is inserted over the entire length. A ^second lumen having a cross-sectional area of 0.5-4.5 mm ² ,
And a third lumen having at least one side hole behind the balloon and having a cross-sectional area of 2.5 to 6.5 mm ² with a sealed tip and capable of retaining its shape. Aortic balloon catheter for injection of cardioplegia with suction route. 2. The balloon is composed of at least one of latex, styrene-butadiene copolymer, silicone rubber, polyurethane, and copolymers thereof, polyolefin elastomer, and polyolefin-based polymer alloy, and the catheter tube has a Shore hardness of 60A to. 65D
An aortic balloon catheter for injecting a cardioplegia solution with a suction route, which is made of the above material.