WO2013146614A1 - Auxiliary clip for use in anastomotic operation - Google Patents
Auxiliary clip for use in anastomotic operation Download PDFInfo
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- WO2013146614A1 WO2013146614A1 PCT/JP2013/058398 JP2013058398W WO2013146614A1 WO 2013146614 A1 WO2013146614 A1 WO 2013146614A1 JP 2013058398 W JP2013058398 W JP 2013058398W WO 2013146614 A1 WO2013146614 A1 WO 2013146614A1
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- anastomosis
- blood vessel
- hole
- pair
- mounting
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/122—Clamps or clips, e.g. for the umbilical cord
- A61B17/1227—Spring clips
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/12—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
- A61B17/128—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
- A61B17/1285—Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1107—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis for blood vessels
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
- A61B2017/1135—End-to-side connections, e.g. T- or Y-connections
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/30—Surgical pincettes without pivotal connections
- A61B2017/306—Surgical pincettes without pivotal connections holding by means of suction
Definitions
- 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 in which a bypass blood vessel is anastomosed to form a bypass (bypass) as a treatment method when stenosis / occlusion or large cerebral aneurysm occurs in a blood vessel in the brain
- a target blood vessel to be bypassed is referred to as a “target blood vessel”
- 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”.
- vascular anastomosis for blood vessels in the brain has been performed mainly by the following procedure.
- the both ends of the predetermined area 100S of the target blood vessel 100 are pinched
- the hatched portion at the center of the predetermined section suggests the presence of a disease such as stenosis or cerebral aneurysm.
- the hemostatic clip include a cerebral aneurysm clip described in Patent Document 1.
- 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).
- 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.
- the conventional vascular anastomosis operation is a surgery accompanied by a risk of cerebrovascular disorder because the brain falls into a temporary ischemic state due to hemostasis by the hemostatic clip.
- 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. .
- Patent Document 3 Utrecht University in the Netherlands has developed a device for anastomosing blood vessels for anastomosis without blocking blood flow (Patent Document 3).
- 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).
- ELANA Excimer Laser-Assisted Non-occlusive Anastomosis
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Auxiliary clip for anastomosis surgery It is characterized by Auxiliary clip for anastomosis surgery.
- 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 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.
- 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.
- 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 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.
- the fastener is a screw or suture thread
- the flange 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 flange parts can be fixed to each other with these screws or suture thread.
- 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 the above (1) to (7), wherein the ratio (long axis: short axis) is (1.3: 1) to (1.7: 1).
- a plurality of suture holes for allowing a suture needle and a suture thread to pass therethrough are provided around the through hole for anastomosis at intervals.
- 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 opening is concentrically formed with the opening end of the anastomosis through hole.
- the auxiliary clip for anastomosis surgery according to any one of the above (1) to (9), wherein a through-hole having a smaller opening at the end is formed.
- the auxiliary clip for anastomosis surgery of the present invention
- 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.
- 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.
- 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
- 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. 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
- FIG. 1 (b) is FIG. It is a side view of (a
- 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
- 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.
- 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
- FIG. 6 is a view showing still another form of the auxiliary clip for anastomosis surgery according to the present invention.
- 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
- FIG. 6 is a view showing still another
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- the pair of mounting portions 1 and 2 are joined to the pair of mounting portions 1 and 2, respectively.
- 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.
- 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] is required for opening and closing.
- 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)
- 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) ).
- 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.
- 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.
- 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).
- the radius may be such that the blood vessel is tightened so as to eliminate the gap so that it is reduced by about 99% (in some cases, within a safe range exceeding that) (Non-patent Document 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. .
- 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.
- 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.
- 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, when targeting the blood vessels of the human brain, the inner radius 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.
- 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.
- the thickness of the wall portion is preferably about 0.3 mm to 0.7 mm within the radius range inside the mounting portion described above.
- the thickness of 0.5 mm is moderately thin with respect to the inner radius of 2.0 to 3.0 mm of the mounting portion, and an appropriate strength can be imparted depending on the material. It is a combination example.
- the length of the mounting portion may be any length that can provide an anastomosis through-hole for connecting the anastomosis blood vessel.
- the length of the attachment part should be a value proportional to the radius inside the attachment part Is preferred.
- 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 preferably 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.
- 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.
- one or more through holes for anastomosis are provided in both attachment parts. It may be.
- 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.
- each mounting portion 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.
- 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 this case is It is about 3.0 mm to 5.0 mm.
- 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.
- (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.
- 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.
- the stitching angle (intersection angle between the target blood vessel and the anastomosis blood vessel) ⁇ shown in FIG. 3B is preferably 30 ° to 60 °. In particular, 40 degrees is preferable, thereby providing a preferable bypass without inhibiting blood flow.
- the opening shape of the through hole for anastomosis is elliptical as shown in FIGS. 1 (a) and 3 (a).
- this elliptical shape is a three-dimensional annular shape formed by interpenetration when two cylinders are obliquely intersected.
- 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 ⁇ shown in FIG.
- 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.
- the preferred example of the elliptical dimension is a long axis length of 3.8 mm and a short axis length. 2.5 mm.
- FIG. 3 shows a preferred embodiment for connecting the anastomosis blood vessel to the anastomosis through hole by stitching.
- 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.
- the size of the thread and needle used for stitching is preferably thread size (6-0) to (9-0), needle size 3 mm to 6 mm (3/8 round needle), among which 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 used and the thickness of the thread. However, in the operation on the blood vessel 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.
- a suturing film 6 is adhered to the inner surface of the mounting portion so as to close the through hole H for anastomosis.
- a through hole 6h having an opening smaller than the opening is formed concentrically with the opening of the through hole H for anastomosis.
- the suture film 6 projects over the entire circumference in the opening of the anastomosis through-hole H by the same amount.
- FIG. 4 shows another preferred embodiment for connecting the anastomosis blood vessel to the anastomosis through hole by stitching.
- 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.
- 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.
- 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. 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.
- 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.
- the anastomosis blood vessel tip and the suture film when they 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.
- 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.
- 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.
- 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.
- 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.
- PTFE polytetrafluoroethylene
- 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. Considering the point that it affects the target blood vessel if it is too thick, and the point that the strength required for suturing cannot be obtained if it is too thin, the preferred thickness is about 0.4 mm to 0.6 mm.
- 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.
- FIG. 5 shows another form of the auxiliary clip (particularly, another form of the connecting portion).
- 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).
- flange portions (1 fa, 1 fb, 2 fa, 2 fb) projecting outward are provided as connecting portions on 2 a and 2 b).
- the brim portion 1fa corresponds to the brim portion 2fa
- the brim portion 1fb and the brim portion 2fb correspond to each other.
- 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.
- a screw, a suture thread, a medical adhesive, and the like can be given.
- screws are used as the fasteners (Sa, Sb)
- a through hole through which the screw passes is provided in one flange portion 1 fa
- a female screw for screwing the screw into the other flange portion 2 fa is provided. It forms and fixes both brim parts.
- 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.
- the brim portion and the fastener constitute the connecting portion.
- 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.
- a medical adhesive is used as the connecting portion, and the joint of the pair of mounting portions is bonded.
- 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.
- FIG. 6 shows another form of the auxiliary clip (particularly, another form of the connecting portion).
- 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 embodiment of the flange portion and the fastener at the other seam is not limited to the embodiment using screws, suture thread, and medical adhesive, and 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.
- 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.
- 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
- 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.
- the spring part is provided so that the pair of mounting parts close to each other.
- the spring member is a hinge and the hinge is provided to open the pair of mounting parts. It may be.
- 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 a saphenous vein (200 mm or more in length when used as an anastomosis blood vessel) collected from under the patient's knee used for conventional vascular anastomosis or an 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) that has been clinically used in cerebral aneurysm clips (Patent Document 1) and the like, and this material is used for the mounting portion and the spring portion. It is mentioned as a preferred embodiment.
- FIGS. 7A the procedure of the operation for giving a bypass to the target blood vessel in the brain is shown in FIGS.
- 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).
- 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.
- 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).
- 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
- 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.
- 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.
- Fig.8 (a) the blood flow from an object blood vessel is interrupted
- 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.
- 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.
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Abstract
Description
図9(a)に示すように、対象血管100の所定区間100Sの両端を止血クリップ(T10、T20)で挟み、血流を一時的に遮断する。前記所定区間の中央のハッチングを施した部分は、狭窄や脳動脈瘤などの疾患の存在を示唆している。前記止血クリップとしては特許文献1に記載された脳動脈瘤クリップなどが挙げられる。
次に、対象血管の血管外表面のうち、吻合すべき部分に縫合糸を通してつまみ上げ(図示せず)、そのつまみ上げた血管を、剪刀(医療用のハサミ)で切除して血管壁に貫通孔を形成し、吻合用孔110、120とする(図9(b))。このとき、形成される吻合用孔の形状は、対象血管の長手方向に沿った方向に長軸を持つ楕円形(長軸と短軸との比は約1.5:1)となるよう術者により調整される。これは、吻合用血管を斜めに連結することで、分岐・結合部近辺にて最適な血流動態と壁面せん断応力(WSS)を得るためである。
次に、図9(c)に示すように、対象血管100と吻合用血管200とが隙間なく吻合されるように、互いの吻合部形状を合わせて縫合を行い、最後に、止血クリップを外して血流を再開させる。 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
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
Next, as shown in FIG. 9 (c), the
この装置は、図10に示す写真図のとおり、吻合用血管内に挿通し得るよう先端がカテーテルと同様の管状となった装置であって、ELANA(Excimer Laser-Assisted Non-occlusive Anastomosis)と命名されている。以下、本明細書においても、特許文献3記載の構成を持った装置を、ELANAと呼んで説明する。
図10に示すとおり、ELANAの先端面の外周縁部にはレーザー出射口が環状に設けられ、中央部には多数の吸引口が設けられている。レーザー光の光源はエキシマレーザー装置である。レーザー出射口から環状に照射されるレーザー光によって、対象血管の管壁を円形に切り取ることができ、かつ、切り取られた管壁片を吸引口に吸い着けて回収できるようになっている。
ELANAを用いた術式は、2011年には米国FDAの認可も取得しており、医療機器としての販売も認められている(現在、日本では未だ認可されていない)。 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
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).
先ず、図11(a)に示すように、吻合用血管200にリング状の補助治具T30を通し、吻合用血管の一方の端部(先端部)を外側へと反転させる。次に、対象血管100の血流を遮断せずに、吻合用血管をリング状の補助治具T30と共に対象血管100に吻合する。図中のT40は縫合用の糸である。
次に、図11(b)に示すように、吻合用血管内にELANAを挿入し、図11(c)に示すように、対象血管の管壁を吸引しながら、先端からレーザー光L10を管壁に照射する。これによって、図11(d)に示すように該管壁に穴をあけ、切り取った管壁片130を吸引口に吸い着けて回収する。
この処置を、対象血管の2箇所に対して別個に行い、最後に2本の吻合用血管の各他端部同士を縫合して連結し一本のバイパス管を完成させる。 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
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
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.
(1)対象血管に吻合用血管を吻合するために用いられる補助クリップであって、
一対の装着部を有し、それぞれの装着部の基本形状は互いに等しい半円筒状であって、その半円筒状の内側の半径は、前記対象血管をはめ込むことができるように選択されており、それによって、前記一対の装着部は、円筒状となるように互いに1つに合わせることで前記対象血管に装着され得るようになっており、
少なくとも一方の装着部の胴体壁面には、前記吻合用血管を接続するための吻合用貫通孔が設けられており、
前記一対の装着部には、前記対象血管に装着可能であるように互いに開閉できかつ互いが1つに合わせられた状態が維持され得るように、互いを開閉可能に連結する連結部が設けられていることを特徴とする、
吻合手術用補助クリップ。
(2)上記連結部として、ばね部が一対の装着部を連結しており、
一対の装着部が、円筒状となるように互いに1つに合わせられた状態において、開閉可能にかつ装着部同士を互いに合わせる方向にばね荷重が作用するように、前記ばね部によって連結されている、上記(1)記載の吻合手術用補助クリップ。
(3)ばね部のばね荷重を発生する部分が、ねじりコイルばねであって、
該ねじりコイルばねの両端部からそれぞれ延びる腕部が、タスキがけ状に交差して上記一対の装着部にそれぞれ接合されており、それによって、前記2つの腕部に対して、前記タスキがけ状に交差する部分よりもねじりコイルばね側に位置する部分に、それらが互いに近づくように外力を加えることによって一対の装着部が開き、該外力を解くことによって一対の装着部が閉じる構成となっている、上記(2)記載の吻合手術用補助クリップ。
(4)一対の装着部のそれぞれには、それら装着部を円筒状となるように互いに1つに合わせたときの合わせ目となる部分に、上記連結部として外側に張り出したツバ部が設けられており、該ツバ部同士を互いに合わせた状態とし留め具によって該ツバ部同士を固定し得る構成となっている、上記(1)記載の吻合手術用補助クリップ。
(5)上記留め具がネジまたは縫合用糸であって、
これらネジまたは縫合用糸によって該ツバ部同士を固定し得るように、互いに合わせられるツバ部には、貫通孔と貫通孔、または、貫通孔とめねじが設けられている、上記(4)記載の吻合手術用補助クリップ。
(6)一対の装着部を円筒状となるように互いに1つに合わせたときの2つの合わせ目のうちの一方の合わせ目には、該一対の装着部が互いに開閉できるように上記連結部として蝶番が設けられており、かつ、
一対の装着部のそれぞれには、前記2つの合わせ目のうちの他方の合わせ目に、外側に張り出したツバ部が上記連結部として設けられており、該ツバ部同士を互いに合わせた状態として留め具によって該ツバ部同士を固定し得る構成となっている、上記(1)記載の吻合手術用補助クリップ。
(7)上記留め具がネジまたは縫合用糸であって、
これらネジまたは縫合用糸によって該ツバ部同士を固定し得るように、互いに合わせられるツバ部には、貫通孔と貫通孔、または、貫通孔とめねじが設けられている、上記(4)記載の吻合手術用補助クリップ。
(8)吻合用貫通孔が、装着部の基本形状である半円筒状の中心軸に沿った方向に長軸を持つ楕円形であって、該楕円形の長軸と短軸の長さの比(長軸:短軸)が、(1.3:1)~(1.7:1)である、上記(1)~(7)のいずれかに記載の吻合手術用補助クリップ。
(9)吻合用貫通孔の周囲には、縫合針および縫合糸を通過させるための縫合用孔が、間隔をおいて複数設けられている、上記(1)~(8)のいずれかに記載の吻合手術用補助クリップ。
(10)装着部の内面には、吻合用貫通孔を塞ぐ位置に縫合用フィルムが接着されており、さらに、該縫合用フィルムには、吻合用貫通孔の開口端と同心状に、該開口端により小さい開口を持った貫通孔が形成されている、上記(1)~(9)のいずれか1項に記載の吻合手術用補助クリップ。 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 flange 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 flange 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 the above (1) to (7), wherein the ratio (long axis: short axis) is (1.3: 1) to (1.7: 1).
(9) In any one of the above (1) to (8), a plurality of suture holes for allowing a suture needle and a suture thread to pass therethrough are provided around the through hole for anastomosis at intervals. 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 opening is concentrically formed with the opening end of the anastomosis through hole. The auxiliary clip for anastomosis surgery according to any one of the above (1) to (9), wherein a through-hole having a smaller opening at the end is formed.
さらに、該装着部の胴体壁面には、吻合用血管を接続し得るように吻合用貫通孔が設けられているので、手術の現場で脳内の血管に直接縫合を行う場合であっても、当該補助クリップを不動に保持することで吻合すべき部位が静止し、縫合作業が改善される。
また、予め別の作業環境の下で、該装着部の吻合用貫通孔に対して吻合用血管を接続しておくことも可能である。これによって、対象血管に対して手術の現場で吻合用血管を縫合するといった困難な作業を回避することも可能である。よって、脳内手術の現場において、顕微鏡を覗きながらの縫合作業の回数を減らすことができるため、手術時の吻合作業の負担を減らすことができ、上記したELANAのような吻合器具がより使い易くなる。 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.
図1に形態の一例を示すように、当該補助クリップは、一対の装着部1、2と、それらを連結するばね部3とを有する構成となっている。それぞれの装着部1、2の基本形状は、互いに等しい半円筒状であって、図3(b)の斜視図のように、それらを1つに合わせると円筒状となる。この半円筒形状の内側の断面形状である半円形の半径は、対象血管をはめ込むことができるように選択されている。よって、対象血管を挟むように一対の装着部1、2を合わせることによって、対象血管の胴体周囲をとりまいて覆う筒として該血管に装着し得るようになっている。
また、一対の装着部1、2のうち、少なくとも一方の装着部(図1の例では片方の装着部1)の胴体壁面には、吻合用貫通孔Hが設けられており、その吻合用貫通孔Hに対して(即ち、装着部1に対して)、または、内部に保持される対象血管に対して、吻合用血管を接続することが可能となっている。
前記一対の装着部1、2には、対象血管に装着可能であるように互いに開閉できかつ互いが1つに合わせられた状態が維持され得るように、装着部1、2を開閉可能に連結する連結部が設けられている。図1の例では、ばね部3が連結部であって、一対の装着部1、2は、円筒状となるように互いに1つに合わせられた状態において、該ばね部3によって開閉可能に連結されており、かつ装着部1、2同士を互いに合わせる方向にばね部3からのばね荷重が作用する構成となっている。 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
In addition, an anastomosis through-hole H is provided on the body wall surface of at least one of the pair of mounting
The pair of mounting
単純な構造としては、弾性材料からなる板状やU字状のばね部材などによって、一対の装着部の一方の合わせ目を蝶番のように連結する形態が例示される。ただしそのような形態では、装着部同士を開くためには、それらが開く方向に外力を加える必要がある。その場合には、グリップ部を握ることで先端部が開く工具が種々存在するので、それらの工具が適用できるように、工具先端が係合し得る部分を設けておけばよい。
図1には、ばね部の好ましい形態が示されている。同図の形態では、ばね部3のばね荷重を発生する部分(ばね本体部分)3aが、ねじりコイルばねであり、その両端部からそれぞれ延びる腕部3b、3cが、タスキがけ状に交差して、一対の装着部1、2にそれぞれ接合されている。このような接合によって、前記2つの腕部3b、3cのそれぞれに対して、前記タスキがけ状に交差する部分よりもねじりコイルばね側に位置する部分(押圧部)に、それら腕部3b、3cが互いに近づくように外力(圧縮力)を加えれば、一対の装着部を開くことができる。図2は、その具体的な開閉操作の様子を示しており、当該補助クリップ(I)の押圧部をクリップ鉗子(II)の先端部で圧縮・解放して、当該補助クリップを開閉している。
図2(b)のように、外部からの単純な圧縮力で装着部が開くという構造は、使い方が簡単であるため、手術時の吻合作業の負担を減らすことができる。
一対の装着部の開閉の移動量は、特に限定はされないが、対象血管にスムーズに装着し得るよう、対象血管の直径と同程度以上に開くことが好ましい。 The
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
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.
ばね本体部分をねじりコイルばねとする場合、その巻き数は、材料や線材の太さ、腕の長さに応じて適宜決定すればよい。 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] is required for opening and closing.
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.
以下、そのような半円形に近い断面形状をも含めて、装着部の断面形状を単に「半円形」と呼ぶ。 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”.
装着部の内側の半径は、該装着部を対象血管に装着し吻合手術を行ったときに、該装着部の端部から血液が漏洩しないように、対象血管に隙間無くぴったりフィットするような半径であることが好ましい。よって、生体に悪影響を及ぼすような血流減少が生じない程度の安全な範囲内において、対象血管の弾力性を利用して該血管の外径を微量だけ縮小(例えば、医師の決定による90%~99%程度の縮小、場合によってはそれを超える安全範囲内での縮小)させるように、該血管を締め付けて隙間を無くすような半径としてもよい(非特許文献5)。実際の対象血管は、金属直管のような円筒とは全く異なり、屈曲し外径も不定であるため、手術の現場において医師が適切な内側半径の装着部を選択するのが好ましい態様である。また、装着部と対象血管との間に医師の決定による微量の隙間をもたせてもよく、その場合には、その隙間を医療用の接着剤などで充填し、血液が漏洩しないようにシールすればよい。
一方、対象血管の外径は、生体の部位によって0.5mm(小動脈)~10.0mm(大動脈)など様々であるが、とりわけ人間の脳では、吻合手術を行うべき対象血管の外径は2.5mm~4.0mm程度である。
よって、人間の脳の血管を対象とする場合には、装着部の内側の半径は、0.8mm~2.2mmが好ましい範囲であり、なかでも1.25mm~2.0mmが特に好ましく有用な範囲である。
当該補助クリップは、装着部の内側の半径を段階的に変えて得られる多数の製品を揃えておき、手術に望んで対象血管に適合するサイズのものを選択できるようにしてもよい。
また、一対の対象血管の合わせ目に生じる隙間の量をネジやスペーサーなどで調整し得る構成とすることによって、対象血管の太さに対応して内部の寸法を微調整し得るようにしてもよい。 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). The radius may be such that the blood vessel is tightened so as to eliminate the gap so that it is reduced by about 99% (in some cases, within a safe range exceeding that) (Non-patent Document 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, when targeting the blood vessels of the human brain, the inner radius 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.
一例を挙げると、装着部の内側の半径が1.0mmの場合には、装着部の長さは7.0mm~9.0mm、特に8mm程度が好ましい長さであり、装着部の内側の半径が1.5mmの場合には、装着部の長さは11.0mm~13.0mm、特に12mm程度が好ましい長さである。 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 preferably about 12 mm.
これに対して、対象血管の特定箇所に2つまたはそれ以上の血管を吻合するというような特殊な場合に対応すべく、両方の装着部に吻合用貫通孔を各1つまたはそれ以上設ける態様であってもよい。
図1(a)の態様では、吻合用貫通孔の開口は、装着部の胴体壁面に閉じた円形や楕円形を描いている。これに対して、一対の装着部の互いの合わせ目に、吻合用貫通孔の開口形状を半分に割った切り欠きをそれぞれの装着部に形成しておき、一対の装着部を合わせたときに、その合わせ目に1つの閉じた円形や楕円形の開口ができるような態様としてもよい。 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.
人間の脳の血管を対象とする場合、吻合手術を行うべき対象血管の外径は上記のように、2.0mm~4.0mm程度であり、その場合に用いられる吻合用血管の外径は3.0mm~5.0mm程度である。
吻合用貫通孔に吻合用血管を接続する場合の接続態様としては、主として下記(A)、(B)の態様が挙げられる。
(A)吻合用血管の端面を吻合用貫通孔内に挿入した状態で、該吻合用血管を装着部に固定する態様。この態様では、0.2mm~1.0mm程度の径の差(隙間)が生じるように、吻合用血管の外径よりも吻合用貫通孔の開口を大きく取るのが好ましい。
(B)吻合用血管の端面が、吻合用貫通孔内に入り込まず、吻合用貫通孔の開口周囲において装着部の外面に接触した状態で、該吻合用血管を装着部に固定する態様。この態様では、吻合用血管の内径と吻合用貫通孔の開口とを一致させるのが好ましい。
上記(A)、(B)のなかでも、血管内異物の影響による血栓の形成の抑制、吻合用血管と対象血管間の内壁再生成(再癒着)の促進、縫合の作業性、接続状態の良否の点などからは、上記(B)の方が好ましい態様である。それぞれの場合の、吻合用貫通孔の開口寸法は、吻合用血管の外径に適合するよう、適宜決定すればよい。 The anastomosis through-hole may be shaped and sized so that the anastomosis blood vessel can be preferably connected.
When targeting blood vessels in 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 this 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 embodiment, 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.
また、図9のように吻合用血管を斜めに接続するようなバイパスでは、図3(b)に示す縫合角度(対象血管と吻合用血管との交差角度)θは30度~60度が好ましく、特に40度が好ましく、これによって血流を阻害することなく好ましいバイパスとなる。この場合の吻合用貫通孔の開口形状は、図1(a)、図3(a)に示すように楕円形となる。この楕円形は、前記円形の場合と同様、2つの円柱を斜めに交差させたときの相貫による立体的な環状形である。この楕円形は、装着部の中心軸に沿った方向(=対象血管の長手方向に沿った方向)が長軸となる。
前記の楕円形(開口を正視したときの平面図に現れる楕円形)の長軸と短軸との比は、図3(b)に示した斜めの縫合角度θの点から、(1.3:1)~(1.7:1)が好ましく、1.5:1程度がより好ましい比率である。
例えば、装着部の内側の半径が1mm(一対の装着部による円筒状の直径の内径が2mm)の場合、前記の楕円形の好ましい寸法例は、長軸長2.5mm、短軸長1.7mmである。また、装着部の内側の半径が1.5mm(一対の装着部による円筒状の直径の内径が3mm)の場合、前記の楕円形の好ましい寸法例は、長軸長3.8mm、短軸長2.5mmである。 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.
図3は、吻合用貫通孔に吻合用血管を縫合によって接続するための好ましい態様を示している。同図の態様では、図3(a)に示すように、吻合用貫通孔Hの周囲に、縫合針および縫合糸を通過させるための縫合用孔4が間隔をおいて複数(図の例では等間隔に8個)設けられており、この縫合用孔を利用して、図3(b)に符号5で縫合部を示すように、吻合用血管Pの先端部を装着部に縫い付けることが可能になっている。
縫合に用いられる糸と針のサイズは、糸サイズ(6-0)~(9-0)、針サイズ3mm~6mm(3/8丸針)が好ましく、なかでも糸サイズ(7-0)、針サイズ4mm(3/8丸針)がより汎用的で好ましいサイズである。
縫合用孔4の口径は、用いられる縫合用針や糸の太さに応じて決定すればよいが、脳の血管に対する手術では、該縫合用孔4の口径は0.4mm~0.6mm程度が好ましく、特に0.5mmが好ましい寸法である。 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
The size of the thread and needle used for stitching is preferably thread size (6-0) to (9-0),
The diameter of the
図4に示す態様では、吻合用貫通孔Hの開口内に張り出した縫合用フィルム6を縫い代として利用し、図4(b)に符号7で縫合部を示すように、吻合用血管Pの先端部を該縫合用フィルム6に縫い付けることが可能になっている。図4(b)では、吻合用貫通孔Hの開口内に張り出した縫合用フィルム6が装着部の外側まで引っ張り出されて管状になっている。 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
In the embodiment shown in FIG. 4, the
尚、図4の縫合用フィルムと、図3(a)に示した縫合用孔とを、両方備えた態様であってもよい。 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.
縫合用フィルムを装着部の内面に接合する方法は特に限定はされず、溶着などの方法を用いてもよいが、シアノアクリレートを主成分にした医療用の接着剤などを用いて接着するのが好ましい態様である。 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.
装着部の各部の詳細や吻合用貫通孔Hの詳細などについては上記した態様と同様である。同図の態様では、図4の形態と同様にフィルム6が設けられており、フィルム6には吻合用貫通孔Hの開口より小さい開口を持った貫通孔6hが形成されているが、図3の態様と同様に縫合用孔を設けてもよい。 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
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
図5に示す形態では、留め具(Sa、Sb)としてネジを用いており、一方のツバ部1faにネジを通過させる貫通孔を設け、他方のツバ部2faに該ネジをねじ込むためのメネジを形成して両ツバ部を固定している。
また、一方のツバ部1fa、他方のツバ部2faの両方に貫通孔を設け、縫合用糸やボルト・ナットによって該ツバ部同士を固定してもよいし、医療用に使用可能な材料からなるリベットによって両ツバ部をかしめる構成としてもよい。 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
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.
(i)ツバ部に加えて、または、ツバ部を設けず、医療用接着剤を連結部として用い、一対の装着部の合わせ目を接着する態様。
(ii)ツバ部を設けず、連結用の薄板部品を、合わせ目をまたぐように当てて、医療用接着剤で接着する態様。
(iii)上記(ii)の連結用の薄板部品を一方の装着部に一体的に設けておく態様。
(iv)一対の装着部を円筒状に合わせ、縫合用糸を胴体に巻き付けて縛る態様。 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.
装着部1、2には、他方の合わせ目に、外側に張り出したツバ部(1f、2f)が連結部として設けられており、留め具Saと貫通孔1hとメネジ2hとによって該ツバ部(1f、2f)同士を固定し得る構成となっている。この他方の合わせ目におけるツバ部と留め具との態様は、図5の形態についての説明と同様、ネジ、縫合用糸、医療用接着剤を用いた態様の他、上記(i)~(iv)などの態様であってよい。
装着部の各部の詳細や吻合用貫通孔Hの詳細などについては上記した態様と同様である。また、同図の形態でも、図5の形態と同様にフィルム6が設けられているが、縫合用孔を設ける態様であってもよい。
蝶番を設けたことによって、図6(a)に示すように、対象血管Qに対する装着が容易になる。 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
The mounting
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
By providing the hinge, as shown in FIG. 6A, the attachment to the target blood vessel Q is facilitated.
当該補助クリップは繰り返しの開閉を行う必要はないから、塑性変形するような材料であっても破壊しなければ蝶番として利用可能である。
蝶番の材料は、生体親和性を有し、一対の装着部を互いに安全につなぎ止めることができる公知の金属やポリマーなどが好ましい。 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.
先ず、図7(a)に示すように、当該補助クリップ(I)の装着部の内面に医療用接着材8を塗布する。当該補助クリップ(I)の吻合用貫通孔には、予め吻合用血管P1が縫合されている。
次に、図7(b)に示すように、対象血管Qの吻合すべき位置(患部を挟んだ2箇所のうちの一方)に、当該補助クリップを図2に示す要領でワンタッチ装着する。
次に、図7(c)に示すように、従来技術として説明したELANAの先端部を吻合用血管P1に挿入する。ELANAの前方には対象血管Qの管壁外面が露出している。
次に、図7(d)に示すように、ELANAによって、対象血管Qの管壁を吸引しながらレーザー光を照射して管壁に穴をあけ、切り取った管壁片Q1を吸引口に吸い着ける。
次に、図8(a)に示すように、止血クリップR1を用いて対象血管からの血流を遮断し、ELANAを引き抜く。
次に、図8(b)に示すように、他方の吻合すべき位置に対しても、上記手順と同様にして、吻合用血管P2が縫合された補助クリップ(I)’を装着し、ELANAによって対象血管Qの管壁に穴をあけ、切り取った管壁片を吸引口に吸い着け、止血クリップR2を用いて対象血管からの血流を遮断し、ELANAを引き抜く。
最後に、図8(c)に示すように、吻合用血管P1、P2の端部同士を縫合し、止血クリップR1、R2を外し、バイパス血管作成の手術を完了する。 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
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.
Claims (10)
- 対象血管に吻合用血管を吻合するために用いられる補助クリップであって、
一対の装着部を有し、それぞれの装着部の基本形状は互いに等しい半円筒状であって、その半円筒状の内側の半径は、前記対象血管をはめ込むことができるように選択されており、それによって、前記一対の装着部は、円筒状となるように互いに1つに合わせることで前記対象血管に装着され得るようになっており、
少なくとも一方の装着部の胴体壁面には、前記吻合用血管を接続するための吻合用貫通孔が設けられており、
前記一対の装着部には、前記対象血管に装着可能であるように互いに開閉できかつ互いが1つに合わせられた状態が維持され得るように、互いを開閉可能に連結する連結部が設けられていることを特徴とする、
吻合手術用補助クリップ。 An auxiliary clip used for anastomosing an anastomosis blood vessel to 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. - 上記連結部として、ばね部が一対の装着部を連結しており、
一対の装着部が、円筒状となるように互いに1つに合わせられた状態において、開閉可能にかつ装着部同士を互いに合わせる方向にばね荷重が作用するように、前記ばね部によって連結されている、請求項1記載の吻合手術用補助クリップ。 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. - ばね部のばね荷重を発生する部分が、ねじりコイルばねであって、
該ねじりコイルばねの両端部からそれぞれ延びる腕部が、タスキがけ状に交差して上記一対の装着部にそれぞれ接合されており、それによって、前記2つの腕部に対して、前記タスキがけ状に交差する部分よりもねじりコイルばね側に位置する部分に、それらが互いに近づくように外力を加えることによって一対の装着部が開き、該外力を解くことによって一対の装着部が閉じる構成となっている、
請求項2記載の吻合手術用補助クリップ。 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. - 一対の装着部のそれぞれには、それら装着部を円筒状となるように互いに1つに合わせたときの合わせ目となる部分に、上記連結部として外側に張り出したツバ部が設けられており、該ツバ部同士を互いに合わせた状態とし留め具によって該ツバ部同士を固定し得る構成となっている、請求項1記載の吻合手術用補助クリップ。 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.
- 上記留め具がネジまたは縫合用糸であって、
これらネジまたは縫合用糸によって該ツバ部同士を固定し得るように、互いに合わせられるツバ部には、貫通孔と貫通孔、または、貫通孔とめねじが設けられている、請求項4記載の吻合手術用補助クリップ。 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. - 一対の装着部を円筒状となるように互いに1つに合わせたときの2つの合わせ目のうちの一方の合わせ目には、該一対の装着部が互いに開閉できるように上記連結部として蝶番が設けられており、かつ、
一対の装着部のそれぞれには、前記2つの合わせ目のうちの他方の合わせ目に、外側に張り出したツバ部が上記連結部として設けられており、該ツバ部同士を互いに合わせた状態として留め具によって該ツバ部同士を固定し得る構成となっている、請求項1記載の吻合手術用補助クリップ。 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. - 上記留め具がネジまたは縫合用糸であって、
これらネジまたは縫合用糸によって該ツバ部同士を固定し得るように、互いに合わせられるツバ部には、貫通孔と貫通孔、または、貫通孔とめねじが設けられている、請求項4記載の吻合手術用補助クリップ。 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. - 吻合用貫通孔が、装着部の基本形状である半円筒状の中心軸に沿った方向に長軸を持つ楕円形であって、該楕円形の長軸と短軸の長さの比(長軸:短軸)が、(1.3:1)~(1.7:1)である、請求項1~7のいずれか1項に記載の吻合手術用補助クリップ。 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).
- 吻合用貫通孔の周囲には、縫合針および縫合糸を通過させるための縫合用孔が、間隔をおいて複数設けられている、請求項1~8のいずれか1項に記載の吻合手術用補助クリップ。 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.
- 装着部の内面には、吻合用貫通孔を塞ぐ位置に縫合用フィルムが接着されており、さらに、該縫合用フィルムには、吻合用貫通孔の開口端と同心状に、該開口端により小さい開口を持った貫通孔が形成されている、請求項1~9のいずれか1項に記載の吻合手術用補助クリップ。 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.
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DE112013001846.2T DE112013001846T5 (en) | 2012-03-30 | 2013-03-22 | Auxiliary clip for use in an anastomosis operation |
JP2014507833A JP6201238B2 (en) | 2012-03-30 | 2013-03-22 | Anastomosis auxiliary clip |
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Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN106901794A (en) * | 2017-03-03 | 2017-06-30 | 高不郎 | Aneurysm clip for treating the arterial side wall with vessel branch and terminal aneurysm |
JP2018000607A (en) * | 2016-07-04 | 2018-01-11 | 泉工医科工業株式会社 | Blood vessel suturing member and blood vessel suturing device |
CN110477985A (en) * | 2019-08-29 | 2019-11-22 | 北京华脉泰科医疗器械有限公司 | Vascular anastomosis with exempt from suture retaining ring |
WO2023218513A1 (en) * | 2022-05-09 | 2023-11-16 | 宇佐美 潤 | Suture aid |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2018236788A1 (en) * | 2017-06-20 | 2018-12-27 | Boston Scientific Scimed, Inc. | Systems for body lumen drainage |
Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002518082A (en) * | 1998-06-10 | 2002-06-25 | コンバージ メディカル, インコーポレイテッド | Sutureless anastomosis system |
JP2004527355A (en) * | 2001-06-07 | 2004-09-09 | エイチビー メディカルズ コーポレーション | Vascular anastomosis device |
EP1576928A1 (en) * | 2004-03-18 | 2005-09-21 | Markus Enzler | Flanged graft for vascular anastomosis and bypass |
JP2011516146A (en) * | 2008-04-03 | 2011-05-26 | アーエムイェー ベー.フェー. | Fixing device and assembly including the fixing device |
Family Cites Families (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
NL1010386C2 (en) * | 1998-10-23 | 2000-04-26 | Eric Berreklouw | Anastomosis device. |
JP2003290233A (en) * | 2002-04-02 | 2003-10-14 | Nippon Cable Syst Inc | Guide shaft for coupling tubular organs |
JP3102614U (en) * | 2003-12-26 | 2004-07-15 | 株式会社カワニシ | Tissue holder |
-
2013
- 2013-03-22 DE DE112013001846.2T patent/DE112013001846T5/en not_active Withdrawn
- 2013-03-22 WO PCT/JP2013/058398 patent/WO2013146614A1/en active Application Filing
- 2013-03-22 JP JP2014507833A patent/JP6201238B2/en not_active Expired - Fee Related
Patent Citations (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2002518082A (en) * | 1998-06-10 | 2002-06-25 | コンバージ メディカル, インコーポレイテッド | Sutureless anastomosis system |
JP2004527355A (en) * | 2001-06-07 | 2004-09-09 | エイチビー メディカルズ コーポレーション | Vascular anastomosis device |
EP1576928A1 (en) * | 2004-03-18 | 2005-09-21 | Markus Enzler | Flanged graft for vascular anastomosis and bypass |
JP2011516146A (en) * | 2008-04-03 | 2011-05-26 | アーエムイェー ベー.フェー. | Fixing device and assembly including the fixing device |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2018000607A (en) * | 2016-07-04 | 2018-01-11 | 泉工医科工業株式会社 | Blood vessel suturing member and blood vessel suturing device |
CN106901794A (en) * | 2017-03-03 | 2017-06-30 | 高不郎 | Aneurysm clip for treating the arterial side wall with vessel branch and terminal aneurysm |
CN110477985A (en) * | 2019-08-29 | 2019-11-22 | 北京华脉泰科医疗器械有限公司 | Vascular anastomosis with exempt from suture retaining ring |
WO2023218513A1 (en) * | 2022-05-09 | 2023-11-16 | 宇佐美 潤 | Suture aid |
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DE112013001846T5 (en) | 2014-12-11 |
JPWO2013146614A1 (en) | 2015-12-14 |
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