JP6201238B2 - Anastomosis auxiliary clip - Google Patents

Description

  The present invention relates to an auxiliary device for performing an operation (vascular anastomosis operation) for anastomosing an end portion of another blood vessel to communicate with a target blood vessel more easily, and more particularly, an auxiliary device useful for blood vessel anastomosis operation in a brain region. It is about.

  Vascular anastomosis surgery (bypass surgery) that forms a bypass (bypass) by anastomosing the bypass blood vessel to the blood vessel as a treatment method when stenosis / occlusion or large cerebral aneurysm occurs in the blood vessel in the brain There is. Hereinafter, in the present specification, a target blood vessel to be bypassed is referred to as a “target blood vessel”, and a tube (blood vessel or artificial tube) that is anastomosed to the target blood vessel and becomes a bypass tube or the like is referred to as “an anastomosis blood vessel”. To distinguish.

Conventionally, in Japan, vascular anastomosis for blood vessels in the brain has been performed mainly by the following procedure.
As shown to Fig.9 (a), the both ends of the predetermined area 100S of the target blood vessel 100 are pinched | interposed by the hemostatic clip (T10, T20), and blood flow is interrupted | blocked temporarily. The hatched portion at the center of the predetermined section suggests the presence of a disease such as stenosis or cerebral aneurysm. Examples of the hemostatic clip include a cerebral aneurysm clip described in Patent Document 1.
Next, on the outer blood vessel surface of the target blood vessel, the portion to be anastomosed is picked up with a suture thread (not shown), and the picked up blood vessel is excised with a scissors (medical scissors) and penetrated into the blood vessel wall. Holes are formed to form anastomosis holes 110 and 120 (FIG. 9B). At this time, the shape of the anastomosis hole formed is an ellipse having a major axis in the direction along the longitudinal direction of the target blood vessel (ratio of major axis to minor axis is about 1.5: 1). It is adjusted by the person. This is to obtain the optimal blood flow dynamics and wall shear stress (WSS) in the vicinity of the branch / joint portion by connecting the blood vessels for anastomosis obliquely.
Next, as shown in FIG. 9 (c), the anastomosis blood vessel 200 and the anastomosis blood vessel 200 are anastomosed together without gaps, and the anastomosis parts are aligned and sutured. Finally, the hemostatic clip is removed. To resume blood flow.

  As described above, the conventional vascular anastomosis surgery is a surgery with a risk of cerebrovascular disorder because the brain falls into a temporary ischemic state due to hemostasis by the hemostatic clip. In addition, because the intracerebral blood vessels to be operated may be thin with an outer diameter of about 2 mm, the suturing operation is difficult, and the influence on the operation time is greatly influenced by the experience and technique of the operator. .

On the other hand, Utrecht University in the Netherlands has developed a device for anastomosing blood vessels for anastomosis without blocking blood flow (Patent Document 3).
As shown in the photograph in FIG. 10, this device has a tubular shape similar to that of a catheter so that it can be inserted into an anastomosis blood vessel, and is named ELANA (Excimer Laser-Assisted Non-occlusive Anastomosis). Has been. Hereinafter, also in this specification, an apparatus having the configuration described in Patent Document 3 will be described as ELANA.
As shown in FIG. 10, a laser emission port is provided in an annular shape at the outer peripheral edge portion of the tip surface of ELANA, and a plurality of suction ports are provided in the central portion. The light source of the laser light is an excimer laser device. The tube wall of the target blood vessel can be cut into a circular shape by the laser beam irradiated in a ring shape from the laser emission port, and the cut tube wall piece can be sucked into the suction port and collected.
The technique using ELANA was approved by the US FDA in 2011 and is also approved for sale as a medical device (currently not yet approved in Japan).

FIG. 11 shows a surgical procedure for making a hole in the vessel wall of the target blood vessel using ELANA and anastomosing the blood vessel for anastomosis.
First, as shown in FIG. 11 (a), a ring-shaped auxiliary jig T30 is passed through the anastomosis blood vessel 200, and one end portion (tip portion) of the anastomosis blood vessel is inverted outward. Next, the anastomosis blood vessel is anastomosed with the target blood vessel 100 together with the ring-shaped auxiliary jig T30 without blocking the blood flow of the target blood vessel 100. T40 in the figure is a suture thread.
Next, as shown in FIG. 11 (b), ELANA is inserted into the blood vessel for anastomosis, and as shown in FIG. 11 (c), the laser beam L10 is piped from the tip while sucking the tube wall of the target blood vessel. Irradiate the wall. Thus, as shown in FIG. 11 (d), a hole is made in the tube wall, and the cut tube wall piece 130 is sucked into the suction port and collected.
This procedure is performed separately for two locations of the target blood vessel, and finally, the other end portions of the two anastomosis blood vessels are stitched together to complete one bypass tube.

  However, when the present inventors examined the technique using ELANA as described above, the first suturing operation for anastomosing the ring-shaped auxiliary jig T30 and the anastomosis blood vessel 200 to the outer surface of the target blood vessel 100 was performed. It was found that (the work shown in FIG. 11 (a)) is very difficult and should be improved. This is mainly because the anastomosis blood vessel 200 is not initially fixed to the surface of the target blood vessel 100. In particular, in the back of the brain, the operation of anastomosing a thin anastomosis blood vessel in which a small ring-shaped auxiliary jig is attached to the wall surface of a thin target blood vessel is an extremely complicated and difficult operation.

Japanese Patent Laid-Open No. 2003-199750 “Cerebroaneurysm Clip” Japanese Patent Application Laid-Open No. 2006-081597 “Forceps for pinching an aneurysm clip” US Patent Application Publication No. 2010/331793 “LASER CATHETER FOR BYPASS SURGERY AND ASSEMBLY COMPRISING SAID CATHETER”

Neurosurgery Journal, Vol. 4, No. 6, Page 588-592 (1995.11), “Clinical study of new titanium cerebral aneurysm clips on CT and MRI (original paper)” Japanese Society of Biorheology Annual Meeting Program, Abstracts, Vol. 34, 96 Mitsugu, June 2011, “Effects of vascular anastomosis angle on blood flow in bypass surgery” Neurosurgical Focus, Vol. 24, No. 2, 2008, “Excimer laser-assisted nonocclusive anastomosis: An emerging technology for use in the creation of intracranial-intracranial and extracranial-intracranial cerebral bypass” Edited by Akira Yamaura, Neurosurgery Atlas (Volume 2), PP96-99, Medical School Publishing Arch Surg, 115 (2), 216-223, 1980, "Hemodynamics for the vascular surgeon"

  An object of the present invention is to be able to be easily attached to a target blood vessel, reduce the blood vessel suturing work in the brain, and eliminate the difficulty of the above-described conventional anastomosis work. It is to provide an auxiliary jig that makes it possible.

The present invention has the following features.
(1) An auxiliary clip used for anastomosing a blood vessel for anastomosis with a target blood vessel,
The basic shape of each mounting portion is a semi-cylindrical shape that is equal to each other, and the inner radius of the semi-cylindrical shape is selected so that the target blood vessel can be fitted, Thereby, the pair of attachment parts can be attached to the target blood vessel by matching one with each other so as to be cylindrical,
An anastomosis through-hole for connecting the anastomosis blood vessel is provided on the body wall surface of at least one mounting portion,
The pair of mounting portions are provided with a connecting portion that can be opened and closed with each other so that they can be mounted on the target blood vessel and can be maintained together. It is characterized by
Auxiliary clip for anastomosis surgery.
(2) As the connecting part, a spring part connects a pair of mounting parts,
In a state where the pair of mounting portions are aligned with each other so as to have a cylindrical shape, the mounting portions are connected by the spring portion so that a spring load acts in a direction in which the mounting portions can be opened and closed and the mounting portions are aligned with each other. The auxiliary clip for anastomosis surgery according to (1) above.
(3) The portion of the spring portion that generates the spring load is a torsion coil spring,
The arm portions extending from both end portions of the torsion coil spring are joined to the pair of mounting portions so as to intersect with each other in a brushed shape, whereby the two arm portions are in the brushed shape. A pair of mounting portions are opened by applying an external force to a portion positioned closer to the torsion coil spring than an intersecting portion so that they approach each other, and the pair of mounting portions is closed by releasing the external force. The auxiliary clip for anastomosis surgery according to (2) above.
(4) Each of the pair of mounting portions is provided with a flange portion projecting outward as the connecting portion at a portion that becomes a joint when the mounting portions are combined with each other so as to be cylindrical. The auxiliary clip for anastomosis surgery according to the above (1), wherein the collar portions are in a state in which the collar portions are aligned with each other, and the collar portions can be fixed with a fastener.
(5) The fastener is a screw or suture thread,
The collar part which is mutually aligned is provided with a through hole and a through hole or a through hole and a female screw so that the collar parts can be fixed to each other with these screws or suture thread. Auxiliary clip for anastomosis surgery.
(6) When the pair of mounting portions are combined with each other so as to form a cylinder, one of the two joints is connected to the connecting portion so that the pair of mounting portions can be opened and closed. As a hinge, and
Each of the pair of mounting portions is provided with a flange portion projecting outward from the other joint of the two joints as the connecting portion, and the flange portions are fastened together. The auxiliary clip for anastomosis surgery according to the above (1), wherein the brim portions can be fixed to each other with a tool.
(7) The fastener is a screw or suture thread,
The collar part which is mutually aligned is provided with a through hole and a through hole or a through hole and a female screw so that the collar parts can be fixed to each other with these screws or suture thread. Auxiliary clip for anastomosis surgery.
(8) The through hole for anastomosis is an ellipse having a major axis in the direction along the central axis of the semi-cylindrical shape that is the basic shape of the mounting portion, and the length of the major axis and the minor axis of the ellipse The auxiliary clip for anastomosis surgery according to any one of (1) to (7), wherein the ratio (major axis: minor axis) is (1.3: 1) to (1.7: 1).
(9) The device according to any one of (1) to (8), wherein a plurality of suture holes for allowing a suture needle and a suture thread to pass therethrough are provided around the anastomosis through hole. Auxiliary clip for anastomosis surgery.
(10) A suturing film is adhered to the inner surface of the attachment portion at a position where the anastomosis through hole is blocked, and the suturing film is concentric with the opening end of the anastomosis through hole. The auxiliary clip for anastomosis surgery according to any one of (1) to (9), wherein a through-hole having a smaller opening at an end is formed.

In the auxiliary clip for anastomosis surgery of the present invention (hereinafter also referred to as “the auxiliary clip”), a pair of members having a shape obtained by dividing a cylindrical body vertically into two are used as attachment parts, and they are connected to each other. Since a connecting part that connects the mounting parts so as to be openable and closable is provided so as to be able to open and close and to maintain the state where they are combined with the original cylinder, the specific part of the target blood vessel is covered. Thus, it can be easily attached and fixed to the blood vessel.
Furthermore, since the through-hole for anastomosis is provided on the body wall surface of the mounting portion so that the anastomosis blood vessel can be connected, even when performing sutures directly on the blood vessels in the brain at the operation site, By holding the auxiliary clip immobile, the site to be anastomosed becomes stationary and the suturing operation is improved.
It is also possible to connect an anastomosis blood vessel to the anastomosis through hole of the mounting portion in advance under another working environment. As a result, it is possible to avoid a difficult operation such as suturing the anastomosis blood vessel at the surgical site with respect to the target blood vessel. Therefore, since the number of suturing operations while looking through a microscope can be reduced at the site of intracerebral surgery, the burden of the anastomosis operation during the operation can be reduced, and the above-described anastomosis instrument such as ELANA is easier to use. Become.

  Further, in a preferred embodiment of the present invention, the pair of attachment portions are connected by the spring portion so as to be aligned with the original cylinder, so that the clip can be easily attached to the target blood vessel with a single opening / closing operation of the clip. The state can be maintained.

FIG. 1 is a view showing an example of a preferred embodiment of an auxiliary clip for anastomosis surgery according to the present invention, FIG. 1 (a) is a front view showing an anastomosis through hole, and FIG. 1 (b) is FIG. It is a side view of (a). The correspondence between each main part shown in these drawings and each symbol is as follows. DESCRIPTION OF SYMBOLS 1; Mounting part, 2; Mounting part, 3; Spring part (connecting part), 3a; Spring main-body part of a spring part, 3b; Arm part of a spring part, 3c: Arm part of a spring part, H: Through hole for anastomosis . FIG. 2 is a view showing a state in which the auxiliary clip according to the embodiment of FIG. 1 is opened and closed by clip forceps. 2A shows a state where the auxiliary clip is closed, and FIG. 2B shows a state where the auxiliary clip is opened. FIG. 3 is a view showing another form of the auxiliary clip for anastomosis surgery according to the present invention. FIG. 3A is a front view showing a form in which a suture needle and a suture hole for passing a thread are further provided around the anastomosis through-hole. FIG. 3B is a perspective view showing a state in which the anastomosis blood vessel is sutured to the anastomosis through hole using the suturing hole. FIG. 4 is a view showing another form of the auxiliary clip for anastomosis surgery according to the present invention. FIG. 4A is a front view showing a form in which a suture film for interposing an anastomosis between a target blood vessel and an anastomosis blood vessel is adhered to the vicinity of the periphery of the through hole for anastomosis and the inner surface of the attachment portion. FIG. 4B is a perspective view showing a state where the anastomosis blood vessel is sutured to the anastomosis through hole using the suturing film. FIG. 5 is a view showing another form of the auxiliary clip for anastomosis surgery according to the present invention. FIG. 5A is a perspective view showing the overall state. In FIGS. 3A and 3C, the film 6 inside is shown as if the mounting portion 1 is transparent so that the presence of the film 6 attached to the inside of the mounting portion can be easily understood. FIG. 5B is a view when a state in which the pair of mounting portions are combined with each other so as to be cylindrical is seen along the direction of the central axis. FIG.5 (c) is a figure when the auxiliary | assistant clip of Fig.5 (a), (b) is seen from upper direction. FIG. 6 is a view showing still another form of the auxiliary clip for anastomosis surgery according to the present invention. FIG. 6A is a perspective view showing a state in which the target blood vessel is fitted into one mounting portion of the auxiliary clip and the other mounting portion is opened. FIG. 6B is a view when a state in which the pair of mounting portions are combined with each other so as to be cylindrical is viewed along the direction of the central axis. FIG. 7 depicts a flow of a series of operations from attaching the auxiliary clip for anastomosis surgery shown in FIG. 4 to a target blood vessel, suturing the anastomosis blood vessel, inserting ELANA, and forming an opening in the target blood vessel. FIG. FIG. 8 is a diagram showing a flow of a series of operations up to completion of the bypass formation following FIG. FIG. 9 is a diagram showing a flow of a series of operations in a conventional blood vessel anastomosis operation (in particular, a bypass plastic operation). FIG. 10 is an enlarged photograph showing the distal end surface of ELANA, which is a blood vessel anastomosis device according to the prior art. Non-patent document 3 is cited. FIG. 11 is a diagram showing an operation procedure for making a through-hole in a vessel wall of a target blood vessel using ELANA, which is a conventional device, and anastomosing a blood vessel for anastomosis.

Below, the structure of the auxiliary clip for anastomosis surgery of this invention is demonstrated in detail along an Example.
As shown in FIG. 1 as an example, the auxiliary clip has a pair of mounting portions 1 and 2 and a spring portion 3 connecting them. The basic shapes of the mounting portions 1 and 2 are the same semi-cylindrical shape, and when they are combined into one as shown in the perspective view of FIG. The semicircular radius which is the inner cross-sectional shape of the semicylindrical shape is selected so that the target blood vessel can be fitted. Therefore, by combining the pair of mounting parts 1 and 2 so as to sandwich the target blood vessel, the target blood vessel can be mounted on the blood vessel as a cylinder that surrounds and surrounds the body of the target blood vessel.
In addition, an anastomosis through-hole H is provided on the body wall surface of at least one of the pair of mounting portions 1 and 2 (one mounting portion 1 in the example of FIG. 1). An anastomosis blood vessel can be connected to the hole H (that is, to the mounting portion 1) or to a target blood vessel held inside.
The pair of mounting portions 1 and 2 are connected to the mounting portions 1 and 2 so that they can be opened and closed with each other so that they can be mounted on the target blood vessel and can be maintained in a single state. A connecting portion is provided. In the example of FIG. 1, the spring portion 3 is a connecting portion, and the pair of mounting portions 1 and 2 are connected to each other so as to be openable and closable by the spring portion 3 in a state of being combined with each other so as to be cylindrical. In addition, the spring load from the spring portion 3 acts in a direction in which the mounting portions 1 and 2 are aligned with each other.

  With the above configuration, for example, as shown in FIG. 2B, by applying an external force against the spring load to the spring portion, the pair of mounting portions 1 and 2 can be easily opened and closed. The attachment to the target blood vessel is also one-touch. In the example shown in FIGS. 2A and 2B, the torsion coil spring of the spring portion is displaced by an aneurysm clip clamping forceps (II) as described in Patent Document 2, and the auxiliary clip (I ) Is opened and closed.

The spring part 3 only needs to be connected so that the pair of mounting parts can be opened and closed and a spring load is applied in a direction in which the two mounting parts are aligned with each other. Any known mechanism may be used as long as it has a structure.
As a simple structure, a form in which one seam of a pair of mounting portions is connected like a hinge by a plate-like or U-shaped spring member made of an elastic material is exemplified. However, in such a form, in order to open the mounting portions, it is necessary to apply an external force in the opening direction. In that case, since there are various tools that open the tip by gripping the grip portion, a portion where the tool tip can be engaged may be provided so that these tools can be applied.
FIG. 1 shows a preferred form of the spring portion. In the form shown in the figure, the portion (spring body portion) 3a that generates the spring load of the spring portion 3 is a torsion coil spring, and the arm portions 3b and 3c that extend from both ends of the spring portion 3 intersect each other in a scissors shape. Are joined to the pair of mounting portions 1 and 2, respectively. By such joining, each of the two arm portions 3b and 3c is placed on a portion (pressing portion) located on the side of the torsion coil spring with respect to the portion intersecting in a scissors shape. If an external force (compression force) is applied so that they approach each other, the pair of mounting portions can be opened. FIG. 2 shows a specific state of the opening / closing operation, in which the pressing portion of the auxiliary clip (I) is compressed and released by the distal end portion of the clip forceps (II) to open and close the auxiliary clip. .
As shown in FIG. 2B, the structure in which the mounting portion is opened by a simple compressive force from the outside is easy to use, and therefore the burden of the anastomosis work during the operation can be reduced.
The movement amount of opening and closing of the pair of attachment portions is not particularly limited, but it is preferable that the opening amount is equal to or larger than the diameter of the target blood vessel so that the attachment can be smoothly performed on the target blood vessel.

The load at which the spring portion tries to align the mounting portions with each other is not particularly limited, but from the viewpoint of the compressive force and operability of the existing cerebral aneurysm clip, for example, the cerebral aneurysm clip described in Patent Document 1 A torque of about 0.5 to 2.5 [Nm] required for opening and closing is preferable.
When the spring body portion is a torsion coil spring, the number of turns may be determined as appropriate according to the material, the thickness of the wire, and the length of the arm.

The basic shape of the mounting part is a semi-cylindrical shape. From the point that the pair of mounting parts are in uniform contact with the outer circumference of the target blood vessel, its cross-sectional shape (the cross-sectional shape when cut perpendicular to the central axis of the semi-cylindrical) In particular, the cross-sectional shape of the inner surface is preferably a semicircular shape (with a fan-shaped center angle of 180 degrees), but a shape close to a semicircular shape (with a fan-shaped center angle of about ± 3 degrees centering on 180 degrees) ).
Hereinafter, the cross-sectional shape of the mounting portion including the cross-sectional shape close to such a semicircular shape is simply referred to as “semicircular”.

The semicircular shape that is the cross-sectional shape of the inner surface of the mounting portion is such that the target blood vessel is preferably fitted, i.e., when the pair of mounting portions are combined into a cylindrical shape, it preferably fits the entire circumference of the target blood vessel. A semi-circular radius may be selected. Hereinafter, the semicircular radius is also simply referred to as “radius inside the mounting portion”.
The radius on the inside of the attachment part is such that when the attachment part is attached to the target blood vessel and an anastomosis is performed, it fits tightly to the target blood vessel so that blood does not leak from the end of the attachment part. It is preferable that Therefore, the outer diameter of the blood vessel is reduced by a minute amount using the elasticity of the target blood vessel within a safe range that does not cause a decrease in blood flow that adversely affects the living body (for example, 90% according to a doctor's decision). It is good also as a radius which tightens this blood vessel and eliminates a gap | interval so that it may reduce about -99% (the reduction | decrease within the safe range exceeding it depending on the case) (nonpatent literature 5). Since the actual target blood vessel is completely different from a cylinder such as a straight metal tube and is bent and the outer diameter is indefinite, it is preferable that a doctor selects a mounting portion with an appropriate inner radius at the operation site. . In addition, a minute gap determined by a doctor may be provided between the attachment portion and the target blood vessel, and in that case, the gap is filled with a medical adhesive or the like and sealed so that blood does not leak. That's fine.
On the other hand, the outer diameter of the target blood vessel varies from 0.5 mm (small artery) to 10.0 mm (aorta) depending on the part of the living body. Especially in the human brain, the outer diameter of the target blood vessel to be subjected to anastomosis surgery is It is about 2.5 mm to 4.0 mm.
Therefore, in the case of targeting blood vessels of the human brain, the radius of the inner side of the mounting portion is preferably in the range of 0.8 mm to 2.2 mm, and particularly preferably 1.25 mm to 2.0 mm. It is a range.
As the auxiliary clip, a large number of products obtained by changing the inner radius of the mounting portion in stages may be prepared so that a size suitable for the target blood vessel can be selected for surgery.
Further, by adopting a configuration in which the amount of the gap generated at the joint of the pair of target blood vessels can be adjusted with a screw or a spacer, the internal dimensions can be finely adjusted in accordance with the thickness of the target blood vessel. Good.

  The thickness of the wall portion of the mounting portion may be appropriately determined according to the strength and inner diameter of the material. When a blood vessel of a human brain is a target, the thickness of the wall portion is preferably about 0.3 mm to 0.7 mm within the radius range inside the mounting portion. Especially, since the thickness of 0.5 mm is moderately thin with respect to the inner radius of the mounting portion of 2.0 to 3.0 mm, it can impart appropriate strength depending on the material. It is a combination example.

The length of the mounting portion (distance L between the end faces shown in FIG. 1A) may be any length that can provide an anastomosis through-hole for connecting the anastomosis blood vessel. Normally, if the target blood vessel becomes thicker, the anastomosis blood vessel will also become thicker and the opening of the through hole for anastomosis will increase accordingly, so the length of the attachment part should be a value proportional to the radius inside the attachment part Is preferred.
For example, when the inner radius of the mounting portion is 1.0 mm, the length of the mounting portion is 7.0 mm to 9.0 mm, particularly about 8 mm, and the inner radius of the mounting portion is preferable. Is 1.5 mm, the length of the mounting portion is preferably 11.0 mm to 13.0 mm, particularly about 12 mm.

The through hole for anastomosis is provided on the body wall surface of at least one of the pair of mounting portions. In a normal mode, as shown in FIG. 1, it is provided on the body wall surface of one mounting portion so as to correspond to a general bypass as shown in FIG.
On the other hand, in order to cope with a special case in which two or more blood vessels are anastomosed at a specific location of the target blood vessel, one or more through holes for anastomosis are provided in both attachment parts. It may be.
In the embodiment of FIG. 1 (a), the opening of the anastomosis through-hole describes a circular shape or an oval shape closed on the body wall surface of the mounting portion. On the other hand, when the pair of mounting portions are combined with each other, a notch obtained by dividing the opening shape of the through hole for anastomosis in half is formed in each mounting portion. It is also possible to adopt a mode in which one closed circular or elliptical opening is formed at the joint.

The anastomosis through-hole may be shaped and sized so that the anastomosis blood vessel can be preferably connected.
When targeting blood vessels of the human brain, the outer diameter of the target blood vessel to be anastomosed is about 2.0 mm to 4.0 mm as described above, and the outer diameter of the blood vessel for anastomosis used in that case is It is about 3.0 mm to 5.0 mm.
As the connection mode when connecting the anastomosis blood vessel to the anastomosis through hole, the following modes (A) and (B) are mainly mentioned.
(A) A mode in which the anastomosis blood vessel is fixed to the attachment portion in a state where the end face of the anastomosis blood vessel is inserted into the anastomosis through hole. In this aspect, it is preferable to make the opening of the anastomosis through-hole larger than the outer diameter of the anastomosis blood vessel so that a difference in diameter (gap) of about 0.2 mm to 1.0 mm is generated.
(B) A mode in which the anastomosis blood vessel is fixed to the attachment part in a state where the end face of the anastomosis blood vessel does not enter the anastomosis through hole and is in contact with the outer surface of the attachment part around the opening of the anastomosis through hole. In this aspect, it is preferable to match the inner diameter of the anastomosis blood vessel with the opening of the anastomosis through hole.
Among the above (A) and (B), suppression of thrombus formation due to the influence of foreign substances in the blood vessel, promotion of inner wall regeneration (re-adhesion) between the blood vessel for anastomosis and the target blood vessel, workability of suturing, connection state The above (B) is a more preferable aspect in terms of quality. What is necessary is just to determine suitably the opening dimension of the through-hole for anastomosis in each case so that it may match the outer diameter of the blood vessel for anastomosis.

The opening shape of the through hole for anastomosis becomes circular when the anastomosis blood vessels are connected at right angles. However, although it is circular in a plan view, in practice, it becomes a three-dimensional annular shape due to intermittence when two cylinders intersect.
Further, in the bypass in which the anastomosis blood vessel is obliquely connected as shown in FIG. 9, the stitching angle (intersection angle between the target blood vessel and the anastomosis blood vessel) θ shown in FIG. 3B is preferably 30 ° to 60 °. In particular, 40 degrees is preferable, thereby providing a preferable bypass without inhibiting blood flow. In this case, the opening shape of the through hole for anastomosis is elliptical as shown in FIGS. 1 (a) and 3 (a). As in the case of the circular shape, this elliptical shape is a three-dimensional annular shape formed by interpenetration when two cylinders are obliquely intersected. The ellipse has a major axis in the direction along the central axis of the mounting portion (= direction along the longitudinal direction of the target blood vessel).
The ratio of the major axis to the minor axis of the ellipse (the ellipse appearing in the plan view when the opening is viewed from the top) is (1.3) from the point of the oblique stitching angle θ shown in FIG. : 1) to (1.7: 1) is preferable, and a ratio of about 1.5: 1 is more preferable.
For example, when the inner radius of the mounting portion is 1 mm (the inner diameter of the cylindrical diameter of the pair of mounting portions is 2 mm), the preferred dimension example of the ellipse is that the major axis length is 2.5 mm, the minor axis length is 1.. 7 mm. In addition, when the inner radius of the mounting portion is 1.5 mm (the inner diameter of the cylindrical diameter of the pair of mounting portions is 3 mm), the preferred example of the elliptical dimension is a long axis length of 3.8 mm and a short axis length. 2.5 mm.

The connection method for connecting the anastomosis blood vessel to the anastomosis through hole is not particularly limited, and may be joined using a medical adhesive or may be connected by suturing.
FIG. 3 shows a preferred embodiment for connecting the anastomosis blood vessel to the anastomosis through hole by stitching. In the embodiment shown in FIG. 3, as shown in FIG. 3 (a), a plurality of suture holes 4 for allowing a suture needle and a suture thread to pass therethrough are provided around the through hole H for anastomosis (in the example shown in the figure). 8) are provided at equal intervals, and the distal end portion of the anastomosis blood vessel P is sewn to the attachment portion as shown by the reference numeral 5 in FIG. Is possible.
The size of the thread and needle used for suturing is preferably a thread size (6-0) to (9-0), a needle size of 3 mm to 6 mm (3/8 round needle), among which the thread size (7-0), A needle size of 4 mm (3/8 round needle) is a more versatile and preferred size.
The diameter of the suture hole 4 may be determined according to the suture needle and thread thickness used, but in the operation on the blood vessels of the brain, the diameter of the suture hole 4 is about 0.4 mm to 0.6 mm. Is preferable, and 0.5 mm is a particularly preferable dimension.

FIG. 4 shows another preferred embodiment for connecting the anastomosis blood vessel to the anastomosis through hole by stitching. In the embodiment shown in FIG. 4, as shown by a hidden line (broken line) in FIG. 4A, a suturing film 6 is adhered to the inner surface of the mounting portion so as to close the through hole H for anastomosis. 6, a through hole 6h having an opening smaller than the opening is formed concentrically with the opening of the through hole H for anastomosis. As a result, the suture film 6 projects over the entire circumference in the opening of the anastomosis through-hole H by the same amount.
In the embodiment shown in FIG. 4, the suture film 6 projecting into the opening of the anastomosis through-hole H is used as a seam allowance, and the distal end of the anastomosis blood vessel P is indicated by a reference numeral 7 in FIG. The portion can be sewn to the suturing film 6. In FIG. 4B, the suturing film 6 projecting into the opening of the anastomosis through-hole H is pulled out to the outside of the mounting portion to form a tubular shape.

  In the embodiment shown in FIG. 4, the amount of the suture film that protrudes into the opening of the through hole for anastomosis varies depending on the size of the opening, but in the case of a vascular anastomosis operation for a blood vessel in the brain, 0.3 mm to About 0.7 mm is a preferable amount. The opening of the suture film with respect to the opening of the anastomosis through hole is also elliptical. For example, when the opening of the anastomosis through hole is elliptical with a major axis length of 3.8 mm and a minor axis length of 2.5 mm, the suture film opening Is preferably an ellipse having a major axis length of 3.0 mm and a minor axis length of 2.0 mm, and the major axis length and minor axis length are respectively 0 of the major axis length and the minor axis length of the opening of the through-hole for anastomosis. .8 times is preferable.

In the embodiment shown in FIG. 4, when the anastomosis blood vessel tip and the suture film are sutured, they may be sutured simply by attaching them together, but one of them is outside the other. It is preferable to sew so as to overlap with each other. In particular, from the viewpoint of suppressing thrombus formation near the sutured part, and promoting regeneration and adhesion of the inner wall of the blood vessel, the anastomosis blood vessel is placed outward so that the target blood vessel and the inner wall of the anastomosis blood vessel are anastomosed. It is preferable to sew on the inside.
In addition, the aspect provided with both the suturing film of FIG. 4 and the suturing hole shown to Fig.3 (a) may be sufficient.

  The material for the suturing film may be any material having biocompatibility, flexibility, strength to withstand suturing, and the like. For example, a film made of a known material or a silicone-based soft material for constituting a tube wall of an artificial blood vessel And the like are preferable. As a known material for constituting the tube wall of an artificial blood vessel, for example, a cloth or nonwoven fabric made of a chemical fiber such as polyester, a film made of a polymer such as polytetrafluoroethylene (PTFE), a film made of a biomaterial, Examples thereof include films made of these composite materials.

  The thickness of the suture film varies depending on the material, but in the case of a vascular anastomosis operation for blood vessels in the brain, the radius on the inner side of the attachment part is as small as 1.25 mm to 2.0 mm, and the suture film is thick. In consideration of a point that affects the target blood vessel if it is too thick and a point that strength required for suturing cannot be obtained if it is too thin, a thickness of about 0.4 mm to 0.6 mm is preferable.

The suturing film may be provided so as to cover the entire inner surface of the mounting portion, or may be provided so as to cover only the region around the anastomosis through-hole as shown in FIG.
The method for joining the suture film to the inner surface of the attachment portion is not particularly limited, and a method such as welding may be used, but the bonding may be performed using a medical adhesive mainly composed of cyanoacrylate. This is a preferred embodiment.

  If a seal is required to prevent blood from leaking from the end or joint of the auxiliary clip, the above-described bioadhesive filling, artificial blood vessel or suture film coated with bioadhesive, etc. What is necessary is just to provide as a seal | sticker suitably.

FIG. 5 shows another form of the auxiliary clip (particularly, another form of the connecting portion). As shown in the figure, each of the pair of mounting portions 1 and 2 has a portion that becomes a joint when the mounting portions are combined with each other so as to be cylindrical (1a and 1b in the mounting portion 1). In the mounting portion 2, flange portions (1 fa, 1 fb, 2 fa, 2 fb) projecting outward are provided as connecting portions on 2 a and 2 b). As shown in FIG. 5B, the brim portion 1fa corresponds to the brim portion 2fa, and the brim portion 1fb and the brim portion 2fb correspond to each other.
The details of each part of the mounting part and the details of the through hole H for anastomosis are the same as those described above. 4, the film 6 is provided similarly to the embodiment of FIG. 4, and the film 6 is formed with a through hole 6h having an opening smaller than the opening of the anastomosis through hole H. A suture hole may be provided as in the above embodiment.

  A pair of mounting portions are separated from each other, and by providing a flange portion at each joint portion, as shown in FIGS. It becomes easy to fix the brim portions by Sa and Sb. Such an embodiment is advantageous in that the mounting is not one-touch as compared with the above-described spring portion, but the configuration is simple and each can be firmly fixed.

As a preferable aspect of the fastener when providing the brim portion, a screw, a suture thread, a medical adhesive, and the like can be given.
In the form shown in FIG. 5, screws are used as the fasteners (Sa, Sb), a through hole through which the screw passes is provided in one flange portion 1 fa, and a female screw for screwing the screw into the other flange portion 2 fa is provided. It forms and fixes both brim parts.
Also, through holes may be provided in both the one flange portion 1fa and the other flange portion 2fa, and the flange portions may be fixed to each other with a suture thread, bolts and nuts, or made of a material that can be used for medical purposes. It is good also as a structure which caulks both collar parts by a rivet.

In the embodiment shown in FIG. 5, the brim portion and the fastener constitute the connecting portion. However, the present invention is not limited to such an embodiment, and a pair of mounting portions that are separated and independent from each other as illustrated below. If it is the aspect which can be fastened together, it can be utilized as a connection part.
(I) A mode in which, in addition to the flange portion, or without providing the flange portion, a medical adhesive is used as the connecting portion, and the joint of the pair of mounting portions is bonded.
(Ii) A mode in which a thin plate part for connection is applied so as to straddle the joint without providing a brim part and bonded with a medical adhesive.
(Iii) A mode in which the connecting thin plate component of (ii) is integrally provided on one mounting portion.
(Iv) A mode in which a pair of attachment portions are aligned in a cylindrical shape, and a suture thread is wound around the trunk and tied.

FIG. 6 shows another form of the auxiliary clip (particularly, another form of the connecting portion). In the form shown in the figure, a hinge J is provided as a connecting portion at one of the two joints when the pair of mounting portions 1 and 2 are combined with each other so as to be cylindrical. The mounting portions 1 and 2 can be opened and closed with each other.
The mounting portions 1 and 2 are provided with a flange portion (1f, 2f) projecting outward at the other joint as a connecting portion, and the flange portion (by the fastener Sa, the through hole 1h, and the female screw 2h) 1f, 2f) can be fixed to each other. The aspect of the brim portion and the fastener at the other seam is the same as the description of the form of FIG. 5, in addition to the aspect using the screw, suture thread, and medical adhesive, the above (i) to (iv ) And the like.
The details of each part of the mounting part and the details of the through hole H for anastomosis are the same as those described above. Also, in the form shown in the figure, the film 6 is provided similarly to the form shown in FIG.
By providing the hinge, as shown in FIG. 6A, the attachment to the target blood vessel Q is facilitated.

As said hinge, the thing of the complicated mechanism used for opening and closing of a normal door and a lid | cover, or the aspect by which the both ends of a simple flat plate and a wire are joined to a pair of mounting part may be sufficient. The aspect of (ii) described above as a connecting part in the form of FIG. 5 (an aspect in which a brim part is not provided and a thin plate part for connection is applied across the seam and bonded with a medical adhesive) It can also be interpreted as an embodiment of a simple hinge in the present invention.
Since the auxiliary clip does not need to be repeatedly opened and closed, even a material that is plastically deformed can be used as a hinge if it is not broken.
The hinge material is preferably a known metal or polymer that has biocompatibility and can safely secure the pair of attachment parts to each other.

  In the form of FIG. 1, the spring part is provided so that the pair of mounting parts close to each other. However, in the form of FIG. 6, the spring member is a hinge and the hinge is provided to open the pair of mounting parts. It may be. As shown in FIG. 6, in this embodiment, there is a connecting portion such as a flange and a fastener at the other joint, so even if the hinge tries to open a pair of mounting portions, the mounting portions are closed against each other. Can be fixed as it is.

  The anastomosis blood vessel that can be used for anastomosis is not particularly limited, but the saphenous vein (200 mm or more in length when used as an anastomosis blood vessel) collected from the patient's knee used for conventional vascular anastomosis or the elbow It is preferable to use a radial artery (length of 200 mm or less when used as an anastomosis blood vessel) that travels from hand to hand (for example, Non-Patent Document 4).

  Each material of the mounting part, spring part, and connecting part may be a medical material having corrosion resistance, biocompatibility, mechanical strength and elasticity required for each part, such as plastic and metal, and a separate material for each. You may use suitably. A preferable material is a titanium alloy (Ti-6Al-4V) conventionally used clinically in a clip for cerebral aneurysm (Patent Document 1) and the like, and this material is used for a mounting portion and a spring portion. It is mentioned as a preferred embodiment.

Hereinafter, taking as an example the case where the auxiliary clip of the aspect shown in FIG. 4 is used, the procedure of the operation for giving a bypass to the target blood vessel in the brain is shown in FIGS.
First, as shown in FIG. 7A, the medical adhesive 8 is applied to the inner surface of the mounting portion of the auxiliary clip (I). The anastomosis blood vessel P1 is sutured in advance to the anastomosis through hole of the auxiliary clip (I).
Next, as shown in FIG. 7 (b), the auxiliary clip is attached to the target blood vessel Q at a position to be anastomosed (one of the two locations across the affected area) in a manner shown in FIG.
Next, as shown in FIG. 7C, the distal end portion of ELANA described as the prior art is inserted into the anastomosis blood vessel P1. The outer wall surface of the target blood vessel Q is exposed in front of ELANA.
Next, as shown in FIG. 7 (d), the ELANA sucks the tube wall of the target blood vessel Q while irradiating laser light to make a hole in the tube wall, and sucks the cut tube wall piece Q1 into the suction port. wear.
Next, as shown to Fig.8 (a), the blood flow from an object blood vessel is interrupted | blocked using the hemostatic clip R1, and ELANA is extracted.
Next, as shown in FIG. 8B, the auxiliary clip (I) ′ to which the anastomosis blood vessel P2 is sutured is attached to the other position to be anastomosed in the same manner as in the above procedure, and ELANA is attached. Then, a hole is made in the tube wall of the target blood vessel Q, the cut wall piece is sucked into the suction port, the blood flow from the target blood vessel is blocked using the hemostatic clip R2, and the ELANA is pulled out.
Finally, as shown in FIG. 8C, the ends of the anastomosis blood vessels P1, P2 are stitched together, the hemostatic clips R1, R2 are removed, and the operation for creating the bypass blood vessel is completed.

  According to the present invention, it becomes possible to avoid suturing of the blood vessel for anastomosis to the target blood vessel, and since it can be easily attached to the target blood vessel, it is difficult to perform the anastomosis work when using the conventional technique ELANA. It became possible to eliminate.

  This application is based on a patent application No. 2012-080485 filed in Japan (filing date: March 30, 2012), the contents of which are incorporated in full herein.

Claims (10)

An auxiliary clip used for anastomosing an anastomosis blood vessel to a target blood vessel,
A pair of mounting portions, the basic shape of each mounting portion is a mutually equal semi-cylindrical, the semi-cylindrical inner radius, semi cylindrical cylindrical body outer peripheral surface of the target blood vessel Are selected so that they can be fitted along the inner surface of the attachment portion of the attachment portion , so that the pair of attachment portions are aligned with each other so as to form a cylindrical shape, thereby coaxially surrounding the trunk of the target blood vessel. It can be attached to the target blood vessel as a cylinder covering and covering the shape ,
An anastomosis through-hole for connecting the anastomosis blood vessel is provided on the body wall surface of at least one mounting portion,
The pair of mounting portions are provided with a connecting portion that can be opened and closed with each other so that they can be mounted on the target blood vessel and can be maintained together. It is characterized by
Auxiliary clip for anastomosis surgery. As the connecting part, the spring part connects the pair of mounting parts,
In a state where the pair of mounting portions are aligned with each other so as to have a cylindrical shape, the mounting portions are connected by the spring portion so that a spring load acts in a direction in which the mounting portions can be opened and closed and the mounting portions are aligned with each other. The auxiliary clip for anastomosis surgery according to claim 1. The part that generates the spring load of the spring part is a torsion coil spring,
The arm portions extending from both end portions of the torsion coil spring are joined to the pair of mounting portions so as to intersect with each other in a brushed shape, whereby the two arm portions are in the brushed shape. A pair of mounting portions are opened by applying an external force to a portion positioned closer to the torsion coil spring than an intersecting portion so that they approach each other, and the pair of mounting portions is closed by releasing the external force. ,
The auxiliary clip for anastomosis surgery according to claim 2.   Each of the pair of mounting portions is provided with a flange portion protruding outward as the connecting portion at a portion that becomes a joint when the mounting portions are combined with each other so as to be cylindrical, The auxiliary clip for anastomosis surgery according to claim 1, wherein the collar portions are in a state in which the collar portions are aligned with each other, and the collar portions can be fixed with a fastener. The fastener is a screw or suture thread,
The anastomosis according to claim 4, wherein the collar parts to be fitted with each other are provided with a through hole and a through hole or a through hole and a female screw so that the collar parts can be fixed to each other by these screws or suture threads. Auxiliary clip for surgery. When the pair of mounting parts are combined with each other so as to be cylindrical, one of the two joints has a hinge as the connecting part so that the pair of mounting parts can be opened and closed with each other. Provided, and
Each of the pair of mounting portions is provided with a flange portion projecting outward from the other joint of the two joints as the connecting portion, and the flange portions are fastened together. The auxiliary clip for anastomosis surgery according to claim 1, wherein the collar portion is configured to be fixed with a tool. The fastener is a screw or suture thread,
The anastomosis according to claim 4, wherein the collar parts to be fitted with each other are provided with a through hole and a through hole or a through hole and a female screw so that the collar parts can be fixed to each other by these screws or suture threads. Auxiliary clip for surgery.   The through hole for anastomosis is an ellipse having a major axis in the direction along the central axis of the semi-cylindrical shape that is the basic shape of the mounting portion, and the ratio of the major axis to the minor axis length (long The auxiliary clip for anastomosis surgery according to any one of claims 1 to 7, wherein (axis: minor axis) is (1.3: 1) to (1.7: 1).   The anastomosis operation according to any one of claims 1 to 8, wherein a plurality of suture holes for allowing a suture needle and a suture thread to pass therethrough are provided at intervals around the through-hole for anastomosis. Auxiliary clip.   A suture film is adhered to the inner surface of the attachment portion at a position for closing the through hole for anastomosis, and the suture film is concentrically with the opening end of the through hole for anastomosis and smaller than the opening end. The auxiliary clip for anastomosis surgery according to any one of claims 1 to 9, wherein a through-hole having an opening is formed.