JP4170236B2 - Connecting device - Google Patents

Description

  The present invention relates to a connection device.

In recent years, surgical coronary artery bypass surgery has been widely performed as a surgical procedure for treating patients suffering from ischemic heart disease.
There are two methods for performing coronary artery bypass surgery: a method in which the heart is temporarily stopped using an oxygenator, and a method in which the heart is pulsated without using the oxygenator. .

The method of performing coronary artery bypass surgery in a state where the heart is pulsated without using the heart-lung machine has an advantage that the recovery after the operation of the patient is accelerated.
However, when coronary artery bypass surgery is performed while the heart is beating, it is necessary to open a very thin coronary artery while the heart is beating and to connect the bypass member to the coronary artery. The arteries are constantly swaying due to the pulsation of the heart and are very difficult to see due to bleeding. Therefore, in the method of performing coronary artery bypass surgery in a state where the heart is pulsated without using a heart-lung machine, an advanced joining technique is required for the work for quickly and reliably joining the coronary artery and the bypass member. The

As bypass grafts used in coronary artery bypass surgery, vein grafts collected from the lower limbs, arterial grafts such as the internal thoracic artery, and gastroepiploic artery are used. Among these, arterial grafts are frequently used because there is little reocclusion of blood vessels after surgery.
However, since there are not many arterial grafts that can be used as bypass grafts, when a bypass must be created for two or three coronary arteries, a vein graft must be used in many cases. Also, depending on the location of the coronary artery undergoing the bypass operation, a good connection may not be formed due to a mismatch between the inner and outer diameters and the blood vessel wall.

  For example, when the internal thoracic artery or gastroepiploic artery is used as a bypass graft (in situ graft), the blood that has flowed to the internal thoracic artery or gastroepiploic artery is sent to the ischemic region. In some cases, the inner diameter is small and sufficient blood flow cannot be obtained after connection.

As a bypass having a high flow rate and high quality, there is an AC bypass using a radial artery. The method using the AC bypass is a method of bypassing the aorta and the ischemic part with a radial artery, and since the blood supply source is the aorta, blood supply at high pressure is possible, and the length of the bypass Has the advantage of low pressure loss.
However, a method of joining the radial artery to the aorta by coronary artery bypass surgery includes a method in which the aorta is partially clamped. However, there is a problem that a patient with advanced arteriosclerosis has a high risk.

  As a method of joining another blood vessel to a blood vessel, for example, there is a method of joining blood vessels by mechanical means after making an opening in the blood vessel (see, for example, Patent Document 1). However, in actual use, obstruction occurred at the mechanical means, and the periphery of the stenosis portion could not be perfused stably for a long period of time.

US Pat. No. 6,524,322

  An object of the present invention is to provide a connecting device that functions stably over a long period of time in surgery for joining blood vessels.

Such an object is achieved by the present invention described in the following (1) to ( 6 ).
(1) A connection device used for joining a blood vessel and a blood vessel with a suture, a tubular member having flexibility, a balloon that is provided on the distal end side of the tubular member, and that is freely expandable and contractible; The tubular member can be inserted, and inserted into the opening of the blood vessel to prevent bleeding from the opening of the blood vessel, and has a temporary fixing member for temporarily fixing the suture , The said temporary fixing member has a substantially conical temporary fixing part which diameter-expands toward the base end side of the said tubular member, The connection instrument characterized by the above-mentioned.
( 2 ) The connection device according to ( 1 ), wherein the connection device further includes operation means for expanding and contracting the balloon provided on the proximal end side of the tubular member.
( 3 ) The temporary fixing member has a one-way valve that allows a flow from the proximal end side to the distal end side and prohibits the opposite, according to (1) or ( 2 ). Connecting equipment.
( 4 ) The connection device according to any one of (1) to ( 3 ), further including a fixing member that fixes the temporary fixing member to the blood vessel.
( 5 ) The connection tool according to any one of (1) to ( 4 ), wherein the temporary fixing member has a maximum outer diameter of 20 mm or less.
( 6 ) The temporary fixing member is mainly composed of one or more resin materials selected from silicone resin, styrene-ethylene-butadiene-styrene resin, and polyurethane resin (1) to ( 5 ). The connection apparatus in any one of.

ADVANTAGE OF THE INVENTION According to this invention, in the operation | movement which joins the blood vessel and the blood vessel, the connection instrument which functions stably over a long term can be provided.
In addition, when a member having a substantially conical temporary fixing portion whose diameter increases toward the proximal end side of the tubular member is used as the temporary fixing member, bleeding from a blood vessel can be further prevented. . Furthermore, since it becomes easy to temporarily fix the suture needle, it is possible to improve operability particularly during surgery.

Hereinafter, the connecting device of the present invention will be described in detail based on preferred embodiments shown in the accompanying drawings.
FIG. 1 is a perspective view showing an example of the connection device of the present invention. FIG. 2 is a cross-sectional view of the tubular member. FIG. 3 is an enlarged view of the distal end side of the tubular member. FIG. 4 is a perspective view of the temporary fixing member. FIG. 5 is a cross-sectional view of the temporary fixing member in the AA direction. FIG. 6 is a sectional view of the temporary fixing member in the BB direction. FIG. 7 is a perspective view of the fixing member. FIG. 8 thru | or 13 is a schematic diagram which shows an example of the usage method of the connecting device of this invention. FIG. 14 is a perspective view showing an example of another embodiment of the temporary fixing member. In the following description, the upper side in FIGS. 1, 4, 5, and 14 is referred to as a “base end”, and the lower side is referred to as a “tip”.

As shown in FIG. 1, the connection device 1 of the present invention has a tubular member 2, and a balloon 3 that can be inflated and deflated is provided on the distal end side thereof.
On the proximal end side of the tubular member 2, operating means 4 for inflating and deflating the balloon 3 is provided.
A temporary fixing member 5 is provided on the proximal end side of the balloon 3 provided on the tubular member 2.
The temporary fixing member 5 is provided with a fixing member 6 for fixing the temporary fixing portion 51 to the blood vessel.

  Hereinafter, each component will be described.

The tubular member (tube) 2 is a long member having flexibility and having a lumen 21 inside.
As shown in FIGS. 1, 2, and 3, the distal end of the tubular member 2 is closed, and a lumen 21 is formed in the tubular member 2. The lumen 21 is used as a flow path for a working fluid such as gas or liquid for inflating and deflating the balloon 3.
A side port 22 that communicates with the outer peripheral wall of the tubular member 2 is formed on the distal end side of the tubular member 2, and communicates with the inside of the balloon 3.

  Examples of the material constituting the tubular member 2 include polyolefin resins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ethylene-copolymer such as ethylene-vinyl alcohol copolymer, Examples thereof include thermoplastic elastomers such as polyamide elastomer and polyester elastomer, styrene resins such as acrylonitrile-butadiene resin and styrene-ethylene-butadiene-styrene resin, and thermoplastic resins such as polyamide, polyvinyl chloride, and polyurethane. Among these, polyamide or polyvinyl chloride having moderate rigidity is preferable. Thereby, operability can be improved.

The outer diameter of the tubular member 2 is not particularly limited, but is preferably 0.5 to 3.0 mm, particularly preferably 1.0 to 2.0 mm. When the outer diameter is within the above range, the bulkiness of the temporary fixing portion 51 can be minimized.
Although the internal diameter of the tubular member 2 is not specifically limited, 0.2-2.5 mm is preferable and 0.5-1.5 mm is especially preferable. When the inner diameter is within the above range, the balloon is excellent in response to inflation and deflation without impairing rigidity.

The balloon 3 has a function of preventing bleeding by bringing the balloon 3 into close contact with the inner wall of the blood vessel when inflated. Further, when contracted, the inside of the tubular member 2 can be easily passed.
As shown in FIG. 3, the balloon 3 is provided so as to cover the side opening 22 of the tubular member 2. The balloon 3 is attached to the tubular member 2 in an airtight or liquid tight manner. Examples of the attachment method include a method in which a member previously formed into a ring shape or a bag shape is joined to the tubular member 2 by an adhesive or fusion.

  Examples of the material constituting the balloon 3 include polyolefin resins such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer, ethylene-vinyl alcohol copolymer, and the like, and polyamides. Thermoplastic elastomers such as elastomers, polyester elastomers, styrene resins such as acrylonitrile-butadiene resins and styrene-ethylene-butadiene-styrene resins, thermoplastic resins such as polyvinyl chloride, polyurethane and polyamide, and thermosetting resins such as silicone resins Is mentioned. Among these, a styrene resin such as styrene-ethylene-butadiene-styrene resin or a silicone resin is preferable in that the bulk when the balloon 3 contracts is small. Thereby, the operativity at the time of inserting the tubular member 2 can be improved.

The operation means 4 for inflating and deflating the balloon 3 has a function of supplying a working fluid to the balloon 3 to inflate and deflate the balloon 3.
In the present embodiment, a syringe is used as the operation means as shown in FIG. 1, but the present invention is not limited to this.

The temporary fixing member 5 has a function of temporarily fixing a suture while preventing bleeding.
The temporary fixing member 5 is used by inserting the distal end side of the temporary fixing member 5 into an opening portion opened by incision and joining a suture needle to the temporary fixing portion 51 when a blood vessel is joined as described later in the usage method. (Suture) can be temporarily fastened.

  As shown in FIG. 4, the temporary fixing member 5 includes a temporary fixing portion 51 and a one-way valve 52 provided on the distal end side (lower side in FIG. 4) of the temporary fixing portion 51. Specifically, the temporary fixing portion 51 has a function of temporarily fixing the suture. The one-way valve 52 has a function of preventing bleeding.

  The outer periphery of the temporary fix | stop part 51 is a cone shape (skirt shape) which expands toward the base end side (FIG. 4 upper side) of the tubular member 2. As shown in FIG. Thereby, the bleeding from the opening part of the blood vessel opened by incision can be prevented effectively.

Further, the inner peripheral surface of the temporary fixing portion 51 is also enlarged in diameter toward the proximal end side (upper side in FIG. 4) of the tubular member 2. Thereby, the clearance gap between the tubular member 2 and the temporary fix | stop part 51 can be enlarged, and, thereby, the temporary fix | stop of a suture needle becomes easy. Furthermore, the temporarily secured suture needle can be easily attached and detached. Furthermore, since it is conical, there is no directionality, and the suture needle can be temporarily fixed from any direction.
As shown in FIGS. 5 and 6, a hole 511 through which the tubular member 2 can be inserted is formed at the distal end portion of the temporary fixing portion 51.

On the other hand, the valve 52 allows the flow from the proximal end side to the distal end side and prohibits the opposite. Thereby, when the one-way valve 52 closes the opening of the blood vessel, bleeding from the blood vessel can be prevented.
As shown in FIG. 5, the AA cross section of the one-way valve 52 is wider than the BB cross section described later.
As shown in FIG. 6, the BB cross section of the one-way valve 52 is substantially V-shaped with the tip end side as a vertex.
On the other hand, a hole (not shown) through which the tubular member 2 can be inserted is formed at the tip of the valve 52.
On the other hand, as the valve 52, a duckbill valve is employed in the present embodiment.
As shown in FIGS. 4 to 6, the distal end side of the temporary fixing portion 51 is bonded to the proximal end side of the one-way valve 52.

  The maximum value of the difference between the inner diameter of the temporary fixing portion 51 and the outer diameter of the tubular member 2 is preferably 2.0 mm or more, and particularly preferably 3.0 to 10 mm. When the outer diameter is within the above range, the operability at the time of temporarily fixing the suture needle is excellent.

  The material constituting the temporary fixing portion 51 is not particularly limited as long as it can be easily pierced by a suture needle, and specifically, a thermoplastic resin such as styrene resin such as styrene-ethylene-butadiene-styrene resin, silicone, and the like. Examples thereof include thermosetting resins such as resins. Further, a metal wire made of stainless steel or the like may be attached to these resins for the purpose of improving rigidity.

On the other hand, examples of the material constituting the valve 52 include thermoplastic resins such as styrene resins such as styrene-ethylene-butadiene-styrene resin, and thermosetting resins such as silicone resins.
The materials constituting the temporary fixing portion 51 and the one-way valve 52 may be different or the same. Moreover, in this Embodiment, although the temporary fix | stop part 51 and the one-sided valve 52 are shape | molded integrally, this invention is not limited to this, The temporary fix | stop part 51 and the one-sided valve 52 are shape | molded separately. You may do it.

The fixing member 6 holds the holding portion 62 when the temporary fixing member 5 is inserted into the opening of the blood vessel, and fixes the temporary fixing member 5 to the blood vessel from the outside of the blood vessel. Thereby, it is possible to perform the operation safely.
As shown in FIG. 1, the fixing member 6 is inserted inside the temporary fixing member 5.
As shown in FIG. 7, the fixing member 6 has a ring-shaped portion 61 on the tip side and a gripping portion 62 provided on a part of the ring-shaped portion 61.
The ring-shaped portion 61 is joined to the vicinity of the bottom portion of the temporary fixing portion 51.
The tubular member 2 can be inserted into the ring-shaped portion 61.
The center of the ring-shaped portion 61 and the center of the hole 511 of the temporary fixing portion 51 are substantially coincident with each other.
In a state where the fixing member 6 is inserted into the temporary fixing member 5, the gripping portion 62 is adapted to be along the inner surface of the temporary fixing portion 51.
In addition, in this Embodiment, although the fixing member 6 is joined to the temporary fixing member 5, it is not limited to this, You may be provided so that attachment or detachment is possible.

  Examples of the material constituting the fixing member 6 include thermoplastic resins such as polyvinyl chloride and polyamide, metals such as piano wire, stainless steel, and nitinol (nickel-titanium alloy). Among these, metals such as piano wire, stainless steel, and nitinol (nickel-titanium alloy) having high rigidity are preferable. Thereby, the temporary fixing member 5 can be sufficiently fixed without being bulky.

  Although the length of the holding | gripping part 62 is not specifically limited, 50-300 mm is preferable and 100-200 mm is especially preferable. When the length is within the above range, the workability during surgery is particularly excellent.

  Next, an example of a method for using the connection device 1 of the present invention will be described with reference to FIGS.

(1) An opening 101 is formed in a blood vessel (for example, an aorta) 100 by incision.

(2) The temporary fixing member 5 of the connection device 1 is inserted into the opening 101 while holding the holding portion 62 of the fixing member 6 (FIG. 8). The opening 101 is spread around the circumference of the temporary fixing member 5, and the temporary fixing member 5 is in close contact with the edge of the opening 101. At this time, the proximal end side of the temporary fixing portion 51 of the temporary fixing member 5 is projected from the blood vessel 100, and the one valve 52 is inserted into the blood vessel 100 (FIG. 8). The one-way valve 52 allows a flow from the proximal end side to the distal end side and prohibits the opposite. Therefore, bleeding from the blood vessel 100 can be prevented.

(3) The suture thread 201 is pierced from the outside of the blood vessel 100 and protrudes from the opening 101 through the inside of the blood vessel 100. Then, the blood vessel 100 and the temporary fixing portion 51 are hooked by the suture needle 200 to which the suture thread 201 is connected, and the suture needle 200 is inserted into the temporary fixing portion 51 and temporarily fixed (FIG. 9). At this time, it is preferable to use approximately eight suture needles.

(4) The tubular member 2 is passed through the hole of the one-way valve 52 through the hole 511 of the temporary fixing portion 51. At this time, the balloon 3 of the tubular member 2 is inserted into the blood vessel 100. Then, a working fluid is supplied from the operation means 4 (not shown) to inflate the balloon 3 (FIG. 10).

(5) The tubular member 2 is pulled out from the blood vessel 100 until the balloon 3 comes into contact with the blood vessel, and the temporary fixing member 5 is also pulled out (FIG. 11). At this time, the opening 101 is covered with the balloon 3 from the inside of the blood vessel 100. Thereby, the bleeding from the blood vessel 100 can be prevented.

(6) The suture needle 200 temporarily fixed to the temporary fixing portion 51 is removed from the temporary fixing portion 51 (FIG. 12). Then, the temporary fixing member 5 is moved to the proximal end side of the tubular member 2 (not shown). Even in this case, since the balloon 3 completely covers the opening 101, the blood vessel 100 does not bleed.

(7) Next, the bypass blood vessel 300 is inserted along the tubular member 2, and the tip of the bypass blood vessel 300 is positioned in the opening 101. Then, the suture needle 200 is temporarily engaged with the bypass blood vessel 300 (for example, a radial artery) (FIG. 13). At this time, a space in which the tubular member 2 is pulled out is left between the blood vessel 100 and the bypass blood vessel 300. In addition, since the balloon 3 of the connection tool remains inflated, it does not bleed.

(8) Finally, the balloon 3 is contracted by the operation means 4 and the tubular member 2 is pulled out of the space. Then, the blood vessel 100 and the bypass blood vessel 300 are sutured along the periphery of the bypass blood vessel 300.

When the blood vessel 100 and the bypass blood vessel 300 are joined through the above-described steps, the joint can be joined without using a clamp, so that arteriosclerosis progresses without causing detachment of an atheroma or the like of the blood vessel inner wall when the clamp is connected. Surgery can be performed safely even on patients who have been treated.
In addition, the connection between the blood vessel 100 and the bypass blood vessel 300 is strong and reliable, and a good bonded state is maintained for a long time for the patient.
In addition, bleeding during the operation can be suppressed, and a safe operation can be performed.

The connection device of the present invention has been described above based on the illustrated embodiment. However, the present invention is not limited to this, and the elements of each component may be replaced with any component that can exhibit the same function. Can do.
For example, a temporary fixing member 7 as shown in FIG. 14 can be used. Hereinafter, it demonstrates centering around difference with the connection instrument 1 of FIG.
The temporary fixing member 7 has a temporary fixing part 71 and a cylindrical fixing part 72.
The temporary fixing portion 71 is joined and fixed to the distal end side of the fixing portion 72.
The temporary fixing portion 71 has a substantially conical shape whose diameter increases toward the base end side.
The outer diameter of the closed tip portion of the tubular member 2 is larger than the inner diameter of the fixed portion 72, and the outer diameter other than the distal end portion of the tubular member 2 is smaller than the inner diameter of the fixed portion 72. Thereby, the tubular member 2 can be slid to the proximal end side until the distal end side of the tubular member 2 hits the distal end of the fixing portion 72, and in this state, bleeding from the opening of the blood vessel can be prevented.
By using such a temporary fixing member 7, the intended performance can be achieved without using a one-way valve.

  The connection device of the present invention can be used when a blood vessel and a blood vessel are joined. More specifically, it is preferably used during coronary artery bypass surgery.

It is a perspective view which shows an example of the connection tool of this invention. It is a fragmentary sectional view of a tubular member. It is an enlarged view of the front-end | tip of a tubular member. It is a perspective view of a temporary fix | stop part. It is sectional drawing of the AA direction of the temporary fix | stop member in FIG. It is sectional drawing of the BB direction of the temporary fix | stop member in FIG. It is a perspective view of a fixing member. It is a fragmentary sectional view which shows the state which inserted the temporary fix member in the blood vessel. It is a fragmentary sectional view showing the state where the suture needle was temporarily fixed. It is a fragmentary sectional view which shows the state which inserted the tubular member in the temporary fix | stop member and inflated the balloon. It is a fragmentary sectional view which shows the state which closed the opening part with the balloon and pulled out the temporary fix | stop member. It is a fragmentary sectional view which shows the state which removed the suture needle | hook from the temporary fix | stop member. It is a fragmentary sectional view which shows the state which has joined the suture needle and the artificial blood vessel. It is a perspective view which shows an example of another temporary fixing member.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Connection instrument 2 Tubular member 21 Lumen 22 Side opening 3 Balloon 4 Operation means 5 Temporary fixing member 51 Temporary fixing part 511 Hole 52 One-way valve 6 Fixing member 61 Ring-shaped part 62 Gripping part 7 Temporary fixing member 71 Temporary fixing part 72 Fixing Part 100 blood vessel 101 opening 200 suture needle 201 suture thread 300 bypass blood vessel

Claims (6)

A connection device used for joining a blood vessel and a blood vessel with a suture,
A tubular member having flexibility;
A balloon which is provided on the distal end side of the tubular member and which can be inflated and contracted;
The tubular member can be inserted, and inserted into the opening of the blood vessel to prevent bleeding from the opening of the blood vessel, and has a temporary fixing member for temporarily fixing the suture , The said temporary fixing member has a substantially conical temporary fixing part which diameter-expands toward the base end side of the said tubular member, The connection instrument characterized by the above-mentioned. The connection device according to claim 1, wherein the connection device further includes operation means for inflating and deflating the balloon provided on a proximal end side of the tubular member. The temporary fixing member is connected appliance according to any one of the proximal side to permit flow to the distal end side, according to claim 1 or 2 in which has a one-way valve that prohibits the opposite. Furthermore, the temporary fixing member, coupling device according to any one of the claims 1 to those having a fixing member for fixing 3 relative to the vessel. The maximum outer diameter of the temporary fixing member is connected instrument according to any one of claims 1 to 4 is 20mm or less. The temporary fixing member is mainly silicone resin, a styrene - ethylene - butadiene - styrene resin, according to any one of 5 claims 1 are those composed of one or more of the resin material selected from polyurethane resin Connection fixtures.

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