JP2017074266A - Ring for cardiac valve ring anchoring surgery - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a ring for a cardiac valve ring anchoring surgery.SOLUTION: A ring 100 for cardiac valve ring anchoring surgery has an annular rigid body 10, the rigid body includes a plurality of holding parts 18 for holding a valve ring anchoring member with a thread, where the thread is stretched between the plurality of holding parts and penetrates the valve ring anchoring member. The holding parts are provided on a circumference formed of the rigid body at prescribed interval apart. The valve ring anchoring member has an annular shape, circumscribes the rigid body, while enclosing the outer periphery of the rigid body, and has flexibility.SELECTED DRAWING: Figure 1A

Description

  The present invention relates to a heart annulus fixed surgical ring and a surgical method using the same.

The aortic valve is located at the base of the aorta, between the Valsalva sinus and the left ventricular outflow tract. To support body blood pressure during systole,
The leaflets of the aortic valve need to be joined sufficiently. Insufficient bonding and backflow of blood leads to heart failure, and it is necessary to improve the function by plastic surgery or the like. When the diameter of the aortic annulus is excessive, the aortic annulus is sewn, so that the joints between the leaflets are optimized and the backflow can be reduced.

  Non-Patent Document 1 discloses a Subvalvular circular annuloplasty method as a surgical method for aortic annulus stitches.

Izumoto H. et al., Leaflet Suspension and Subvalvular Annuloplasty in Aortic Valve Prolapse, Asian Cardiovascular and Thoracic Annals, 2009, vol.17, pp.278-281

  The heart annulus fixation surgical ring according to one aspect of the present disclosure has an annular rigid body, and the rigid body is provided with a plurality of holding portions for holding the annulus fixation member with a thread. The thread is stretched between the plurality of holding portions and penetrates the annulus fixing member, and the holding portions are provided at predetermined intervals on a circumference formed by the rigid body. The annulus fixing member is annular, circumscribes the outer periphery of the rigid body, circumscribes the rigid body, and has flexibility.

FIG. 1A is a perspective view showing a schematic configuration of a heart valve annulus fixed surgical ring according to a first embodiment. FIG. 1B is a plan view showing a schematic configuration of the heart annulus fixation surgical ring of the first embodiment. FIG. 1C is a side view showing a schematic configuration of the heart annulus fixation surgical ring of the first embodiment. FIG. 2A is a perspective view showing a schematic configuration of the cardiac annulus fixation surgical assembly of the second embodiment. FIG. 2B is a plan view showing a schematic configuration of the cardiac annulus fixation surgical assembly of the second embodiment. FIG. 2C is a side view showing a schematic configuration of the cardiac annulus fixation surgical assembly of the second embodiment. FIG. 3A is a perspective view showing a schematic configuration of a heart valve annulus fixed surgical ring according to a third embodiment. FIG. 3B is a plan view showing a schematic configuration of a heart valve annulus fixed surgical ring according to a third embodiment. FIG. 3C is a side view showing a schematic configuration of the heart annulus fixation surgical ring of the third embodiment. FIG. 4A is a perspective view showing a schematic configuration of the heart valve annulus fixation surgical assembly of the fourth embodiment. FIG. 4B is a plan view showing a schematic configuration of the cardiac annulus fixation surgical assembly of the fourth embodiment. FIG. 4C is a side view showing a schematic configuration of the cardiac annulus fixation surgical assembly of the fourth embodiment. FIG. 5A is a process diagram showing an aortic annulus fixation surgical method according to a fifth embodiment, and shows a step of installing a suture with a double-ended needle provided with a pre-jet on the annulus, along the direction of blood flow. It is sectional drawing cut off. FIG. 5B is a process diagram showing the aortic annulus fixation operation method according to the fifth embodiment, and shows a step of installing a suture with a double-ended needle provided with a pre-jet on the annulus, as viewed from the aorta side. It is a top view. FIG. 6A is a process diagram showing an aortic annulus fixation surgical method according to a fifth embodiment, and shows a step of installing a suture with a double-ended needle provided with a pre-jet over the entire circumference of the annulus. It is sectional drawing cut along. FIG. 6B is a process diagram showing the aortic annulus fixation surgical method according to the fifth embodiment, and shows a step of installing a suture with a double-ended needle provided with a pre-jet over the entire circumference of the annulus. FIG. FIG. 7A is a process diagram showing an aortic annulus fixation surgical method according to a fifth embodiment, and shows a step of sewing a suture thread through an annulus fixation member attached to a heart annulus fixation surgical ring. It is sectional drawing cut along the flow direction. FIG. 7B is a process diagram showing the aortic annulus fixation surgical method according to the fifth embodiment, and shows a step of sewing a suture thread through an annulus fixation member attached to a heart annulus fixation surgical ring. It is the top view seen from the side. FIG. 8A is a process diagram showing an aortic annulus fixation operation method according to a fifth embodiment, in which an annulus fixation member attached to a heart annulus fixation operation ring is connected to a valve on the left ventricular outflow tract side from the Valsalva sinus side. It is sectional drawing cut along the blood-flow direction which shows the step moved to a ring part. FIG. 8B is a process diagram showing the aortic annulus fixation operation method according to the fifth embodiment, in which the annulus fixation member attached to the heart annulus fixation operation ring is connected to the valve from the Valsalva sinus side to the left ventricular outflow tract side. It is the top view seen from the aorta side which shows the step moved to a ring part. FIG. 9A is a process diagram showing an aortic annulus fixation surgical method according to a fifth embodiment, and includes a step of ligating a suture in a state where an annulus fixation member is attached to a heart annulus fixation surgical ring. It is sectional drawing cut along the blood flow direction shown. FIG. 9B is a process diagram showing the aortic annulus fixation surgical method according to the fifth embodiment, and includes a step of ligating a suture in a state where the annulus fixation member is attached to the heart annulus fixation surgical ring. It is the top view seen from the aorta side to show. FIG. 10A is a process diagram showing an aortic annulus fixation surgical method according to a fifth embodiment, and shows a step of removing a heart annulus fixation surgical ring after completion of ligation of an annulus fixation member in a blood flow direction. It is sectional drawing cut along. FIG. 10B is a process diagram showing the aortic annulus fixation surgical method according to the fifth embodiment, and shows a step of removing the heart annulus fixation surgical ring after completion of ligation of the annulus fixation member, as viewed from the aorta side. FIG.

  Annulus shrinkage refers to reducing the diameter of the annulus by sewing the annulus by a surgical procedure when the diameter of the annulus is excessive. The inventor has intensively studied a surgical method for aortic annulus stitches in which the annulus fixing member is placed inside a blood vessel or heart. As a result, the following knowledge was obtained.

  With reference to Non-Patent Document 1, the following first method can be considered. First, an ePTFE felt having a thickness of 0.6 mm is formed into a strip shape having a width of about 5 mm. Prepare a 5-0 polypropylene yarn with an ePTFE pre-jet attached to the center and needles connected to both ends. With the strip stretched, the thread is hung from the aorta side of the base of the aortic valve to the left ventricular outflow tract in the form of a horizontal mattress (a mode where the tissue surface and the prejet are in flat contact) and passed through the ePTFE felt strip. The ligation is performed at the time when 5 to 6 yarns are applied, and when the entire circumference has been applied, the excess strip is cut off, and the ends are stitched together with 5-0 polypropylene yarn to finish.

  In this method, the finally obtained valve ring diameter varies due to ePTFE felt expansion and contraction and an error in setting a thread sewing margin. As a result, there is a problem that an error such as the valve ring diameter being larger or smaller than expected is generated.

  A second method has been considered as an improved method for reducing such problems. In the second method, a hair dilator having the same size as the valve ring diameter expected in advance is used. The above-described 0.6 mm thick ePTFE felt cut into a strip shape having a width of about 5 mm is wound around this, and the rest is cut off, and the ends are sewn together with 5-0 polypropylene thread to form an ePTFE felt ring. . A thread is put around the entire circumference of the annulus, and only the ePTFE felt ring is brought close to the annulus and stitched.

  Although this method improves the problems associated with the setting error of the thread sewing margin, the intended annulus diameter is difficult to realize because the ePTFE felt expands and contracts and the stitched portion contracts when ligating. There is a drawback.

  As a further improvement, a third method using Gore-Tex® artificial blood vessels was investigated. In the third method, Gore-Tex (registered trademark) artificial blood vessels are used. Gore-Tex (registered trademark) artificial blood vessel is a material similar to ePTFE felt, but a film (outer coating) is wound around the outer periphery, and expansion and contraction is greatly suppressed. This is fixed to the annulus in the same manner as described above.

  Although the problem that ePTFE felt expands and contracts by this method is reduced, there still remains a drawback that it is difficult to realize the intended annulus diameter because the stitched portion is distorted or contracted when ligating.

  Based on the above considerations, the inventors sewn the seamless annular annulus fixing member on the heart annulus in a state in which the thread is held on the heart annulus fixing surgical ring, and then cut the thread. I thought of removing the ring. By using this method, it is easy to realize the intended valve ring diameter. The above surgical method can also be applied to heart valves other than the aortic valve. By stabilizing the shape of the annulus fixing member with the ring and the thread, the annulus diameter can be easily set to a desired size. Sutures are frequently used in surgery. Temporarily securing the annulus fixing member to the ring using a thread and removing the annulus fixing member from the ring can be easily performed by a surgeon, with few mistakes, and additional equipment. It is also low cost because it is unnecessary.

  Each embodiment will be described below with reference to the drawings. In the following description, the same or corresponding members are denoted by the same reference numerals throughout all the embodiments and drawings, and the description of the above-described members is omitted.

  Each of the embodiments described below shows a desirable specific example. Numerical values, shapes, materials, components, arrangement positions and connection forms of components, steps, order of steps, and the like shown in the following embodiments are merely examples, and do not limit the present disclosure. In addition, among the constituent elements in the following embodiments, constituent elements that are not described in the independent claims indicating the highest concept of the present disclosure are described as optional constituent elements. In order to facilitate understanding, the drawings schematically show each component, and the shape and dimensional ratio may not be accurate. In the method, if necessary, the order of the steps can be changed, and other known steps can be added.

(Embodiment)
The first heart annulus fixing surgical ring according to the embodiment has an annular rigid body, and the rigid body is provided with a plurality of holding portions for holding the annulus fixing member with a thread. Is stretched between a plurality of holding portions and penetrates the annulus fixing member, and the holding portions are provided at predetermined intervals on the circumference formed by the rigid body. It is annular, circumscribes the outer periphery of the rigid body, circumscribes the rigid body, and has flexibility.

  “Rigid body” means that the shape of the annulus fixation member can be kept constant when thread is passed through the annulus fixation member or the annulus fixation member is inserted into the heart during cardiac annulus fixation surgery. It has the rigidity of. The degree of rigidity can be appropriately set based on ordinary knowledge in the technical field of cardiac surgery.

  “Holding the annulus fixation member” means that, in cardiac annulus fixation surgery, when the thread is passed through the annulus fixation member or when the annulus fixation member is inserted into the heart, the operation is adversely affected. This means that the annulus fixation member is fixed to the heart annulus fixation surgical ring to such an extent that distortion does not occur in the annulus fixation member. The degree of fixation can be appropriately set based on ordinary knowledge in the technical field of cardiac surgery.

  The “predetermined interval” means that a distortion that adversely affects the operation of the valve when the thread is passed through the annulus fixation member or the annulus fixation member is inserted into the heart during the heart annulus fixation operation. The interval at which the annulus fixation member can be fixed to the heart annulus fixation surgical ring to such an extent that it does not occur in the annulus fixation member. The degree of fixation can be appropriately set based on ordinary knowledge in the technical field of cardiac surgery.

  The distortion that adversely affects the operation may be a distortion in which the annulus fixing member is detached from the heart annulus fixing surgical ring, or the annulus fixing member is valved in such a state that the distortion has occurred. It may be distorted so as to be medically inappropriate when fixed to the ring part. The holding is temporary, and once the annulus fixing member is fixed to the annulus, the heart annulus fixing surgical ring can be easily removed from the annulus fixing member.

  “Having flexibility” means flexibility that can function properly as an annulus fixing member when placed in the heart. The degree of flexibility can be appropriately set based on ordinary knowledge in the technical field of cardiac surgery.

  The “heart valve” refers to any one of an aortic valve, a mitral valve, a tricuspid valve, and a pulmonary valve. However, the above-mentioned ring for cardiac annulus fixation surgery is most suitably used for annulus fixation surgery for an aortic valve.

  “Annulus” refers to the area around the base of the heart valve. The annulus is not necessarily academically strict.

  The ring formed by the heart valve ring-fixing surgical ring may be a closed ring or an open ring. The shape of the ring formed by the heart valve annulus-fixing surgical ring is not particularly limited, and may be a circular ring, an elliptical ring, or a distorted ring.

  The heart valve annulus surgical ring is made of metal (for example, stainless steel, titanium alloy, gold, silver, copper) and plastic (for example, fluorine resin such as polyethylene, polypropylene, polycarbonate, polyethylene terephthalate, pre-tetrafluoroethylene), etc. Can be done. The heart valve ring-fixing surgical ring may be made of a single material or a composite material. The heart valve annulus-fixing surgical ring may be configured as a single member or may be configured from a plurality of members.

  The heart annulus fixation surgical ring may be hollow. That is, there is nothing inside the heart valve annulus-fixing surgical ring, and even when in use, nothing other than the thread described later may be present.

  The holding unit may have any configuration as long as it can hold the annulus fixing member. The holding part may be, for example, a through hole provided in a heart valve ring-fixing surgical ring. Or the groove | channel provided in the ring for heart valve ring fixation surgery may be sufficient, for example. Alternatively, for example, it may be a protrusion provided on a ring for fixing a heart valve annulus. The holding portion may be configured integrally with the heart valve annulus fixed surgical ring. The holding part uses a thread to fix the annulus fixing member to the heart annulus fixing surgical ring.

  The annulus fixing member is placed in the blood vessel or the heart after the operation. The heart annulus fixing surgical ring is removed from the annulus fixing member at the time of surgery, and thus is not left in the body.

  The second heart valve annulus fixed surgical ring according to the embodiment is the first heart valve annulus fixed surgical ring, wherein the rigid body has a circumference, and the holding portion divides the circumference into six equal parts. It is provided at each position.

  In such a configuration, the holding portion can hold the annulus fixing member more stably than the holding portion is provided at a position that divides the circumference into four equal parts. Further, the operation time can be reduced as compared with the case where the holding portion is provided at a position where the circumference is equally divided into eight. Since the heart valve divides the circumference into approximately three equal parts, a holding portion is provided at a position where the circumference is equally divided by six, which is a multiple of 3, so that positioning when passing the suture through the annulus fixing member is easy. Become. It should be noted that “equal division” does not need to be strictly equal, and it is needless to say that a certain amount of error is allowed as long as it does not hinder the operation. The number and interval of the holding portions are not necessarily limited to the above. The holding parts may be provided at non-uniform intervals.

  The third heart valve annulus-fixing surgical ring according to the embodiment is the first or second heart valve annulus-fixing surgical ring, wherein the rigid body has a circumferential concave surface toward the outer side of the circumference formed by the rigid body. The holding portion is a through hole formed at the bottom of the concave surface and penetrating the rigid body between the outer side and the inner side of the circumference, and the holding portion is formed using a thread that passes through the through hole and the annulus fixing member. The annulus fixing member is configured to be held rigidly.

  The diameter of the through hole is, for example, a size that allows a surgical suture to pass through, and can be, for example, 0.5 mm or more and 2 mm or less. The diameter of the through hole may be not less than 0.7 mm and not more than 1.5 mm. The diameter of the through hole may be 0.9 mm or greater and 1.2 mm or less.

  A fourth heart annulus fixation surgical ring according to the embodiment is the first or second heart annulus fixation surgical ring, wherein the holding portion is formed along a plane intersecting a circumference formed by a rigid body. The holding portion is configured to hold the annulus fixing member on the rigid body using a thread wound around the groove and penetrating the annulus fixing member.

  The depth of the groove can be 0.1 mm or more and 2 mm or less. The depth of the groove may be 0.3 mm or more and 1.5 mm or less. The depth of the groove may be 0.5 mm or more and 1 mm or less.

  The width of the groove can be 0.1 mm or more and 2 mm or less. The width of the groove may be not less than 0.3 mm and not more than 1.5 mm. The width of the groove may be not less than 0.5 mm and not more than 1 mm.

  A fifth heart annulus fixation surgical ring according to the embodiment is any one of the first to fourth heart annulus fixation surgical rings, wherein the rigid body has a circumference and an outer diameter of the circumference. However, it is 16 mm or more and 28 mm or less. The outer diameter of the circumference may be 16 mm or greater and 26 mm or less. The outer diameter of the circumference may be 18 mm or greater and 24 mm or less.

  The axial length of the heart valve annulus-fixing surgical ring can be 1 mm or more and 7 mm or less. The axial length of the heart valve annulus-fixing surgical ring can be 2 mm or more and 6 mm or less. The axial length of the heart valve annulus-fixing surgical ring can be 2 mm or more and 3 mm or less. The axial length of the heart valve annulus-fixing surgical ring can be 3 mm or more and 5 mm or less.

  A sixth heart valve annulus surgical assembly according to an embodiment includes a heart valve annulus surgical ring and an annulus fixation member, and the heart annuloplasty surgical ring has an annular rigid body, A plurality of holding portions for holding the annulus fixing member by a thread are provided, wherein the thread is stretched between the plurality of holding portions and penetrates the annulus fixing member. Is provided on the circumference formed by the rigid body at a predetermined interval, and the annulus fixing member is a seamless, closed annular shape with a smooth outer surface, and circumscribes the rigid body while surrounding the rigid body. And it has flexibility.

  The annulus fixing member may have a short cylindrical shape, for example. In this case, the axial length of the annulus fixing member can be 2 mm or more and 14 mm or less. The axial length of the annulus fixing member may be 4 mm or more and 12 mm or less. The axial length of the annulus fixing member may be 4 mm or more and 6 mm or less. The axial length of the annulus fixing member may be 6 mm or more and 10 mm or less. The inner diameter of the annulus fixing member can be 16 mm or more and 28 mm or less. The inner diameter of the annulus fixing member may be 16 mm or greater and 26 mm or less. The inner diameter of the annulus fixing member may be 18 mm or greater and 24 mm or less.

  The annulus fixing member may be made of a sheet material. In this case, the radial thickness of the sheet material can be 0.3 mm or more and 0.9 mm or less. The radial thickness of the sheet material may be 0.4 mm or more and 0.8 mm or less. The radial thickness of the sheet material may be not less than 0.5 mm and not more than 0.7 mm.

  The annulus fixing member can be constituted by, for example, an ePTFE (expanded polytetrafluoroethylene) tube. ePTFE has high biocompatibility. More specifically, the annulus fixing member can be composed of an ePTFE tube provided with a reinforcing membrane (outer coating). The reinforcing membrane is a membrane for reducing the diameter expansion with time. The reinforcing film can be made of ePTFE thin tape. By disposing the reinforcing film, the expansion and contraction of the annulus fixing member is suppressed and the surface is smoothed. By suppressing the expansion and contraction, it is possible to suppress the temporal change of the valve ring diameter that occurs after the operation. By smoothing the surface, friction between the annulus fixing member and the surface of the human body tissue is reduced, and the influence on the human body due to the operation can be reduced.

  “Seamless” means that the annulus fixing member is integrally formed. The ring formed by the annulus fixing member is a closed ring. The absence of a seam is effective in suppressing expansion and contraction.

  “To circumscribe the rigid body while surrounding the outer periphery of the rigid body” means, for example, that the annulus fixing member and the heart annulus fixing surgical ring are concentric, and the inner wall of the annulus fixing member and the heart annulus fixing surgical ring The state where the outer periphery is in contact.

  “The outer surface is smooth” means that the friction between the annulus fixing member and the surface of the human tissue has such a degree of smoothness that does not adversely affect the heart or blood vessel tissue. As a conventional annulus fixing member, a structure body in which Dacron of synthetic fiber (PET fiber) is woven or knitted is known, but the surface of the structure body is not smooth. For this reason, when Dacron is installed on the annulus of the aortic valve, the biological tissue may be damaged by surface friction.

  An assembly refers to a structure formed by combining a plurality of independent parts.

  A seventh heart annulus fixation surgical assembly according to the embodiment is the sixth heart annulus fixation surgical assembly, wherein the rigid body has a circumference, and the holding portion divides the circumference length into six equal parts. It is provided at each position.

  An eighth cardiac annulus fixation surgical assembly according to an embodiment is the seventh cardiac annulus fixation surgical assembly, wherein the rigid body has a circumferential concave surface toward the outside of a circumference formed by the rigid body, The holding portion is a through-hole formed in the bottom of the concave surface and penetrating the rigid body between the outer side and the inner side of the circumference, the annulus fixing member is wound around the concave surface, and the thread passes through the through-hole and the valve The annulus fixing member is held on the rigid body in a state where the ring fixing member is sewn on the rigid body.

  “Wound around the concave surface” means that the annulus fixing member surrounds the heart annulus fixing surgical ring over the entire circumference formed by the concave surface.

  A ninth heart annulus fixation surgical assembly according to an embodiment is the seventh heart annulus fixation surgical assembly, wherein the holding portion is a groove formed along a plane intersecting a circumference formed by a rigid body. The annulus fixing member is held on the rigid body in a state where the annulus fixing member is sewn onto the rigid body while the thread is wound around the groove.

  A tenth cardiac annulus fixation surgical assembly according to the embodiment is the cardiac annulus fixation surgical assembly according to any one of the sixth to ninth aspects, wherein the rigid body has a circumference, and the outer diameter of the circumference is It is 16 mm or more and 28 mm or less.

  An eleventh heart valve annulus fixing surgical assembly according to an embodiment is the heart valve annulus fixing surgical assembly according to any one of the sixth to tenth aspects, wherein the valve annulus fixing member includes an ePTFE sheet. It consists of

  A twelfth heart annulus fixation surgical assembly according to an embodiment is the heart valve annulus fixation surgical assembly according to any one of the sixth to eleventh aspects, wherein the axial length of the annulus fixation member is a heart valve. It is sewn by being longer than the axial length of the ring-fixed surgical ring.

(First embodiment)
1A, 1B, and 1C are a perspective view, a plan view, and a side view, respectively, showing a schematic configuration of a heart valve annulus-fixing surgical ring according to a first embodiment. Hereinafter, the heart valve annulus-fixing surgical ring 100 according to the first embodiment will be described with reference to FIGS. 1A to 1C.

  The heart valve annulus-fixing surgical ring 100 includes an annular rigid body 10. A circumferential concave surface 12 is formed toward the outer side of the circumference formed by the rigid body 10. The diameter of the circumference formed by the bottom of the concave surface 12 is smaller than the diameter of the circumference formed by the outer circumference 14 of the rigid body 10 and larger than the diameter of the circumference formed by the inner circumference 16 of the rigid body.

  A through hole 18 is formed in the bottom of the concave surface 12 so as to penetrate the rigid body 10 between the outer side and the inner side of the circumference at a position that divides the circumference formed by the rigid body 10 into six equal parts, that is, every 60 degrees. That is, the number of through holes 18 formed in the heart valve annulus-fixing surgical ring 100 is six. The through hole 18 is an example of a holding part.

  As described in the second embodiment, the annulus fixing member 100 is held on the rigid body 10 using a thread that penetrates the through hole 18 and the annulus fixing member. The thread is stretched between the plurality of through holes 18 and penetrates the annulus fixing member. For example, 4-0 polypropylene yarn (diameter: 0.150 mm or more and 0.199 mm or less) can be used as the yarn. As the thread, a surgical suture can be used.

  The heart valve annulus-fixing surgical ring 100 has an inner diameter ID of 20 mm and an outer diameter OD of 22 mm. The radial thickness T of the heart valve annulus-fixing surgical ring 100 is 2 mm. The axial length L of the heart valve annulus-fixing surgical ring 100 is 2 mm. The depth D of the concave surface 12 is 1 mm. The diameter of the through hole 18 is 0.5 mm. The axial direction refers to an axis that passes through the center of the circumference formed by the heart valve annulus-fixing surgical ring 100 and is perpendicular to the surface formed by the circumference.

  Needless to say, the diameter (inner diameter and outer diameter) of the heart valve annulus-fixing surgical ring 100 can be appropriately set according to the annulus diameter of the patient. The axial length L of the heart annulus fixing surgical ring 100 can be about half of the axial length of the annulus fixing member used. The diameter of the through hole 18 may be slightly larger than the maximum diameter of the thread and needle to be used.

(Second embodiment)
2A, 2B, and 2C are a perspective view, a plan view, and a side view, respectively, showing a schematic configuration of a heart valve annulus fixation surgical assembly according to a second embodiment. Hereinafter, the heart valve annulus fixed surgical assembly 200 according to the second embodiment will be described with reference to FIGS. 2A to 2C.

  The heart valve annulus fixing surgical assembly 200 is a surgical assembly in which the annulus fixing member 50 is held on the heart annulus fixing surgical ring 100 of the first embodiment. Since the heart valve annulus-fixing surgical ring 100 can be the same as that of the first embodiment, the corresponding components are denoted by the same reference numerals and detailed description thereof is omitted.

  The annulus fixing member 50 is a seamless and closed ring, has a smooth outer surface, circumscribes the outer periphery of the rigid body 10, circumscribes the rigid body 10, and has flexibility. The inner diameter of the annulus fixing member 50 substantially coincides with the outer diameter of the heart annulus fixing surgical ring 100. Since the annulus fixing member 50 is slightly stretchable, the heart annulus fixing surgical ring 100 can be fitted into the annulus fixing member 50. The annulus fixing member 50 is made of an ePTFE sheet provided with a reinforcing film. Specifically, for example, Gore-Tex (registered trademark) stretch graft standard wall artificial blood vessel straight type II SGS-223L (inner diameter 22 mm) made of ePTFE can be used as the annulus fixing member 50. The inner diameter of Gore-Tex (registered trademark) stretch graft standard wall artificial blood vessel straight type II can be selected from 16 mm to 24 mm in 2 mm increments.

  The annulus fixing member 50 is held in the through hole 18 by a thread that passes through the annulus fixing member 50. More specifically, the annulus fixing member 50 is held on the rigid body 10 by the thread 30 penetrating the through hole 18 and the annulus fixing member 50.

  The annulus fixing member 50 is wound around the concave surface 12. That is, the annulus fixing member 50 surrounds the concave surface 12 along the circumference formed by the concave surface 12. The thread 30 holds the annulus fixing member 50 on the rigid body 10 in a state where the annulus fixing member 50 is sewn onto the rigid body 10 while passing through the through hole 18. As the yarn 30, 4-0 polypropylene yarn is used.

  The lower end of the annulus fixing member 50 substantially coincides with the lower end of the rigid body 10. On the other hand, the upper end of the annulus fixing member 50 is located above the upper end of the rigid body 10. In other words, the axial length of the annulus fixation member 50 is longer than the axial length of the heart annulus fixation surgical ring 100. The upper end of the annulus fixing member 50 forms a sewing margin 20. The heart annulus fixed surgical ring 100 does not exist inside the stitch margin 20 (see FIG. 2C).

  The thread 30 is stretched between the plurality of through holes 18 and penetrates the annulus fixing member 50. 2B, the thread 30 penetrating the annulus fixing member 50 and the through hole 18 in this order at the 12:00 position on the circumference of the rigid body 10 extends downward in the drawing, The through hole 18 and the annulus fixing member 50 are penetrated in this order at the hour position. Further, the thread 30 extends rightward in the drawing along the concave surface 12 on the surface of the annulus fixing member 50, and penetrates the annulus fixing member 50 and the through hole 18 in this order at the 4 o'clock position. Further, the thread 30 extends in the upper left direction of the drawing and penetrates the through hole 18 and the annulus fixing member 50 in this order at the 10 o'clock position. Furthermore, the thread 30 extends downward in the drawing along the concave surface 12 on the surface of the annulus fixing member 50, and penetrates the annulus fixing member 50 and the through hole 18 in this order at the 8 o'clock position. Further, the thread 30 extends in the upper right direction of the drawing and penetrates the through hole 18 and the annulus fixing member 50 in this order at the 2 o'clock position. Further, the thread 30 extends to the left in the drawing along the concave surface 12 on the surface of the annulus fixing member 50 and is fastened to the thread at the other end at the 12 o'clock position.

  With this configuration, the annulus fixing member 50 can be held on the rigid body 10 with a single thread 30. After the annulus fixing member 50 is sewn to the annulus, the thread 30 can be easily removed from the annulus fixing member 50 and the heart annulus fixing surgical ring 100 by simply cutting the thread 30 at one location. The ring-fixing surgical ring 100 can be removed from the annulus fixing member 50.

  The inner diameter id of the annulus fixing member 50 is 22 mm, and the outer diameter od is 23.2 mm. The radial thickness t of the annulus fixing member 50 is 0.6 mm. The axial length l of the annulus fixing member 50 is 5 mm.

  Needless to say, the diameter (inner diameter and outer diameter) of the annulus fixing member 50 can be appropriately set according to the target annulus diameter. The axial length l of the annulus fixing member 50 can be appropriately adjusted according to the size of the patient's heart, the required strength of the annulus fixation, etc., and can be, for example, about 4 mm to 5 mm. .

(Third embodiment)
FIGS. 3A, 3B, and 3C are a perspective view, a plan view, and a side view, respectively, showing a schematic configuration of a heart valve annulus-fixing surgical ring according to a third embodiment. The heart valve annulus-fixing surgical ring 300 according to the third embodiment will be described below with reference to FIGS. 3A to 3C.

  The heart valve annulus-fixing surgical ring 300 includes an annular rigid body 11. The rigid body 11 has a so-called donut shape. As a general rule, a circle arranged in a plane parallel to the rotation axis at a predetermined interval from the rotation axis (the central axis of the rigid body 11) is rotated once around the rotation axis. Creates a 3D figure to be rotated. That is, the rigid body 11 has a convex surface 15 that extends toward the outer side of the circumference formed by the rigid body 11 and a convex surface 17 that extends toward the inner side of the circumference formed by the rigid body 11. The central axis of the rigid body 11 is an axis that passes through the center of the circumference formed by the heart valve annulus-fixing surgical ring 300 and is perpendicular to the surface formed by the circumference.

  Grooves 19 are formed in the rigid body 11 at positions that divide the circumference formed by the rigid body 11 into six equal parts, that is, every 60 degrees. The groove 19 is formed so as to go around the rigid body 11 along a plane intersecting the circumference formed by the rigid body 11. The number of grooves 19 formed in the heart valve annulus-fixing surgical ring 300 is six. The groove 19 is an example of a holding part.

  As described in the fourth embodiment, the annulus fixing member 300 is held on the rigid body 11 by using a thread wound around the groove 19 and penetrating the annulus fixing member. The thread is stretched between the plurality of grooves 19 and penetrates the annulus fixing member. For example, 4-0 polypropylene yarn (diameter: 0.150 mm or more and 0.199 mm or less) can be used as the yarn. As the thread, a surgical suture can be used.

  The inner diameter ID2 of the heart valve annulus-fixing surgical ring 300 is 20 mm, and the outer diameter OD2 is 22 mm. The radial thickness T2 of the heart valve annulus-fixing surgical ring 300 is 1 mm. The axial length L2 of the heart valve annulus-fixing surgical ring 300 is 2 mm. The depth of the groove 19 is 0.5 mm. The width of the groove 19 is 0.5 mm.

  Needless to say, the diameter (inner diameter and outer diameter) of the heart valve annulus-fixing surgical ring 300 can be appropriately set according to the annulus diameter of the patient. The axial length L2 of the heart annulus fixation surgical ring 300 can be about half of the axial length of the annulus fixation member used. The diameter of the through-hole 18 can be made slightly larger than the maximum diameter of the thread and needle used.

(Fourth embodiment)
4A, 4B, and 4C are a perspective view, a plan view, and a side view, respectively, showing a schematic configuration of the heart valve annulus fixed surgical assembly of the fourth embodiment. Hereinafter, the heart valve annulus fixed surgical assembly 400 according to the fourth embodiment will be described with reference to FIGS. 4A to 4C.

  The cardiac annulus fixation surgical assembly 400 is a surgical assembly in which the annulus fixation member 50 is held on the heart annulus fixation surgical ring 300 of the third embodiment. Since the heart valve annulus-fixing surgical ring 300 can be the same as that of the third embodiment, the corresponding components are denoted by the same reference numerals, and detailed description thereof is omitted.

  The thread 30 is stretched between the plurality of through holes 18 and penetrates the annulus fixing member 50. The annulus fixing member 50 is held in the through hole 11 by a thread 30 that passes through the annulus fixing member 50. More specifically, the annulus fixing member 50 is held on the rigid body 11 by a thread 30 wound around the groove 19 and penetrating the annulus fixing member 50.

  The annulus fixing member 50 is wound around the convex surface 15. That is, the annulus fixing member 50 surrounds the convex surface 15 along the circumference formed by the convex surface 15. The thread 30 is wound around the groove 19 and holds the annulus fixing member 50 on the rigid body 11 in a state where the annulus fixing member 50 is sewn on the rigid body 11. As the yarn 30, 4-0 polypropylene yarn is used.

  The axial length of the annulus fixation member 50 is longer than the axial length of the heart annulus fixation surgical ring 300. One end of the annulus fixing member 50 forms a sewing margin 20. The heart annulus fixed surgical ring 300 does not exist inside the stitch margin 20 (see FIG. 4C).

  In addition to the above, since the annulus fixing member 50 can be the same as that described in the second embodiment, the corresponding components in FIGS. 2A to 2C and FIGS. Detailed description will be omitted.

  4B, the thread 30 passes through the annulus fixing member 50 at the 12 o'clock position on the circumference of the rigid body 11, and is wound around the groove 19 and fastened. It extends downward, is wound around the groove 19 at the 6 o'clock position, and is fastened through the annulus fixing member 50. Further, another thread 30 passes through the annulus fixing member 50 at the 4 o'clock position, extends around the groove 19 and fastens, and then extends in the upper left direction of the drawing. And is fastened through the annulus fixing member 50. Further, another thread 30 penetrates the annulus fixing member 50 at the 8 o'clock position, and is wound around the groove 19 and fastened, and then extends in the upper left direction of the drawing. At the 2 o'clock position, the groove 19 And is fastened through the annulus fixing member 50.

  With this configuration, the annulus fixing member 50 is held on the rigid body 11 by the three threads 30. In addition, after the annulus fixing member 50 is sewn to the annulus, the thread 30 can be easily removed from the annulus fixing member 50 and the heart annulus fixing surgical ring 300 by simply cutting the thread 30 and the heart valve. The ring-fixing surgical ring 300 can be removed from the annulus fixing member 50.

  The inner diameter id of the annulus fixing member 50 is 22 mm, and the outer diameter od is 23.2 mm. The radial thickness t of the annulus fixing member 50 is 0.6 mm. The axial length l of the annulus fixing member 50 is 5 mm.

  Needless to say, the diameter (inner diameter and outer diameter) of the annulus fixing member 50 can be appropriately set according to the annulus diameter of the patient. The axial length l of the annulus fixing member 50 can be appropriately adjusted according to the size of the patient's heart, the required strength of the annulus fixation, and the like.

(5th Example)
FIGS. 5-10 is process drawing which shows the aortic annulus fixation operation method concerning 5th Example. 5A and 5B show a step of installing a suture with a double-ended needle having a pre-jet on the annulus. 6A and 6B show a step of installing a suture with a double-ended needle having a pre-jet over the entire circumference of the annulus. 7A and 7B show a step of sewing a suture thread through an annulus fixation member attached to a heart annulus fixation surgical ring. 8A and 8B show steps of moving the annulus fixation member attached to the heart annulus fixation surgical ring from the Valsalva sinus side to the annulus on the left ventricular outflow tract side. 9A and 9B show a step of ligating the suture in a state where the annulus fixing member is attached to the heart annulus fixing surgical ring. 10A and 10B show a step of removing the heart annulus fixation surgical ring after completion of ligation of the annulus fixation member. The cross-sectional view is a cross-sectional view cut along the direction of blood flow, and the plan view is a plan view of the heart side (left ventricular outflow tract side) from the aorta side (Valsalva sinus side).

  5 to 10, an example of using the heart valve annulus fixed surgery assembly 200 of the second embodiment will be described as an example. However, the heart valve annulus fixed surgery assembly 400 of the fourth embodiment and other heart annulus fixed surgery are described. A similar operation can be performed using the assembly.

  A suture 60 having needles 62 and 64 at both ends and a pre-jet 66 near the center is prepared. The suture thread 60 is passed through the prejet 66 from the back side to the front side, and from the front side to the back side so as to reciprocate once between the front side and the back side. It is sewn into a shape.

  As the pre-jet 66, Gore-Tex (registered trademark) EPTFE patch II (model number: PC-0625) cut out to an appropriate size is used. Instead of the pre-jet 66, the suture thread 60 may be passed through a flexible thin plastic tube.

  First, as shown in FIGS. 5A and 5B, both ends of the suture thread 60 are penetrated from the Valsalva sinus 88 side of the annulus 82 to the left ventricular outflow passage 86 side. Through this step, the suture 60 is fixed to the annulus 82 via the pre-jet 66. The site for fixing the annulus fixation member is close to the surgical annulus but does not necessarily match, and is appropriately determined by the surgeon based on the patient's heart condition and treatment policy. The pre-jet 66 is fixed to the annulus 82 by the suture 60 in the form of a horizontal mattress, that is, the main surface of the pre-jet and the tissue surface of the annulus 82 are in surface contact.

  Next, as shown in FIG. 6A and FIG. 6B, the suture thread 60 is fixed via the pre-jet 66 on the Valsalva sinus side over the entire circumference of the annulus portion 82. For example, three sutures 60 can be fixed to the corresponding valve annulus 82 for each of the three leaflets 84. In this case, nine sutures 60 are used. Note that the number of sutures 60 to be fixed may vary depending on the size of the annulus portion 82 and the like. The number of sutures 60 per one leaflet 84 may be 3 or more and 5 or less. The suture thread 60 may be fixed so that portions (prejet 66) through which the suture thread 60 penetrates the annulus portion 82 are arranged at equal intervals on the circumference formed by the annulus portion 82 in a plan view.

  Next, as shown in FIGS. 7A and 7B, using needles 62 and 64, both ends of the suture thread 60 are placed around the sewing margin 20 of the heart annulus fixation surgical assembly 200 and the circumference of the annulus fixation member 50. Pass from the outside to the inside. The same operation is performed for all the sutures 60. At this time, the position where the suture thread 60 is passed through in plan view may be determined in correspondence with the position where the suture thread 60 penetrates the annulus 82. The positions where the suture thread 60 is passed may be equally spaced. There are three leaflets 84, and the circumference is divided into approximately three equal parts. In the heart valve annulus-fixing surgical assembly 200, the holding portion is provided so as to divide the circumference into six equal parts, and the thread 30 extends so as to connect the holding portions facing each other. The position can be easily determined.

  Next, as shown in FIGS. 8A and 8B, the suture thread 60 between the annulus 82 and the annulus fixing member 50 is pulled out to the inside of the annulus fixing member 50, so that the annulus fixing member 50 is Is moved to the vicinity of the valve annulus 82 in the left ventricular outflow passage 86. The suture thread 60 between the annulus 82 and the annulus fixing member 50 is completely pulled out, and the annulus fixing member 50 contacts the annulus 82 in the left ventricular outflow passage 86.

  Next, as shown in FIG. 9A and FIG. 9B, both ends of each suture thread 60 are tied to each other, and each suture thread 60 is ligated, whereby the annulus portion 82 is connected to the annulus fixing member 50 and the prejet 66. Fix between. When the ligation of the suture thread 60 is completed for the entire circumference of the valve annulus 82, the sewing of the valve annulus 82 is completed. Furthermore, the thread 30 is cut and removed.

  Next, as shown in FIGS. 10A and 10B, the heart annulus fixing surgical ring 100 is removed from the annulus fixing member 50 to complete the installation of the annulus fixing member 50. By installing the annulus fixing member 50, the diameter of the annulus portion 82 is reduced and stabilized. Therefore, the backflow of the aortic valve can be reduced. In FIG. 10B, the annulus fixing member 50 is illustrated as still maintaining a circular shape, but this is not necessarily the case, and may be appropriately modified depending on the shape of the annulus. However, in the present embodiment, since the annulus fixing member 50 is made of a material that does not substantially expand and contract, even if it is deformed, the circumferential length of the annulus fixing member 50 is not substantially changed.

  Specifically, an artificial blood vessel made of ePTFE with a reinforcing film can be used as the annulus fixing member 50. The reinforcing membrane can be made of ePTFE. In such a configuration, the diameter of the annulus portion 82 can be stably maintained at a desired size over a long period of time. Specifically, for example, Gore-Tex (registered trademark) stretch graft standard wall artificial blood vessel straight type II can be used.

  In addition, although the above description illustrates the case where the annulus of the aortic valve is fixed, it may be any other heart valve, for example, a mitral valve, a tricuspid valve, or a pulmonary valve. For the mitral valve, the tricuspid valve, and the pulmonary valve, the smoothness of the surface of the annulus fixing member 50 is not required so much, but by using the heart annulus fixing operation ring, the annulus fixing member during the operation is used. It is the same that the shape of 50 can be stabilized and the diameter of the annulus is easily set to a desired size.

(Sixth embodiment)
Surgery may be performed as follows. That is, a Gore-Tex (registered trademark) artificial blood vessel equivalent to the expected annulus diameter is separated into a concentric circle with a width of about 5 mm. A metal ring created to fit the size of the artificial blood vessel is inserted inside. This metal ring is grooved every 60 degrees. The artificial blood vessel is held on the ring with three threads by fixing with 4-0 polypropylene thread using a groove opposite to this groove by 180 degrees. This can prevent the artificial blood vessel from falling off the metal ring when the artificial blood vessel is rubbed against the annulus. In the same manner as described above, the 5-0 polypropylene yarn with ePTFE pre-jet is hung on the entire circumference of the valve annulus, and then passed evenly through an artificial blood vessel with a metal ring. By pulling out the thread between the annulus and the artificial blood vessel, the artificial blood vessel is guided to the annulus and then all the threads are ligated. When the ligation is completed, remove the three fixing threads and remove the metal ring.

  In addition, when the groove was made into two at four positions every 90 degrees, this drop-out could not be prevented. Further, it is theoretically possible to increase the number, but the procedure becomes complicated.

[Surgery method]
The present disclosure can also be realized as the following surgical method.

The first surgical method is a surgical method for fixing the aortic annulus by sewing the annulus fixing member to the aortic annulus,
The annulus fixing member is seamless, has a closed annular shape, has flexibility, and has a smooth outer surface.

  The second surgical method is a first surgical method, in which the annulus fixing member is composed of an ePTFE sheet provided with a reinforcing film.

The third surgical method is a surgical method for fixing the aortic annulus by sewing the annulus fixing member to the aortic annulus,
The annulus fixing member is seamless, has a closed annular shape, and has flexibility,
Before the annulus fixing member is sewn to the heart annulus, the annulus fixing member is held around the heart annulus fixing surgical ring while surrounding the outer periphery of the heart annulus fixing surgical ring,
Here, the heart annulus fixation surgical ring is
An annular rigid body,
The rigid body is provided with a plurality of holding parts for holding the annulus fixing member, and the holding parts are provided at predetermined intervals on the circumference formed by the rigid body, and the annulus is fixed by a thread. Holding the member rigidly,
Here, the thread is stretched between the plurality of holding portions and penetrates the annulus fixing member,
In a state where the annulus fixing member is held by the holding part, the annulus fixing member is sewn to the annulus.

  The fourth surgical method is a third surgical method, in which the rigid body has a circumference, and the holding portions are provided at positions that divide the circumference into six equal parts.

  The fifth surgical method is the third or fourth surgical method, and holds the annulus fixing member on the holding portion with a thread that penetrates the annulus fixing member.

  The fifth surgical method is the third or fourth surgical method, wherein the rigid body has a circumferential concave surface toward the outside of the circumference formed by the rigid body, and the holding portion is formed at the bottom of the concave surface and has a circumference. A through-hole that penetrates the rigid body between the outside and the inside of the annulus, the annulus fixing member is wound around the concave surface, and the annulus is sewn onto the rigid body while threading the thread through the through-hole. The fixing member is held in a rigid body.

  A sixth surgical method is the third or fourth surgical method, wherein the holding portion is a groove formed along a surface intersecting a circumference formed by the rigid body, and the thread is wound around the groove. The annulus fixing member is held on the rigid body by sewing the annulus fixing member on the rigid body.

  The seventh operation method is any one of the third to sixth operation methods, wherein the rigid body has a circumference, and the outer diameter of the circumference is 16 mm or more and 28 mm or less.

  In addition, also in the said surgery method, the deformation | transformation similar to embodiment thru | or a 1st-6th Example is possible.

  From the foregoing description, many modifications and other embodiments of the present invention are obvious to one skilled in the art. Accordingly, the foregoing description should be construed as illustrative only and is provided for the purpose of teaching those skilled in the art the best mode of carrying out the invention. The details of the structure and / or function may be substantially changed without departing from the spirit of the invention.

DESCRIPTION OF SYMBOLS 10 Rigid body 11 Rigid body 12 Concave surface 14 Outer periphery 15 Convex surface 16 Inner periphery 17 Convex surface 18 Through-hole 19 Groove 20 Sewing allowance 30 Yarn 50 Annulus fixing member 60 Suture thread 62 Needle 64 Needle 66 Prejet 82 Annulus 84 Valve leaflet 88 Valsalva sinus 86 Left ventricular outflow tract 100 Heart annulus fixed surgical ring 200 Heart annulus fixed surgical assembly 300 Heart annulus fixed surgical ring 400 Heart annulus fixed surgical assembly

Claims (12)

An annular rigid body,
The rigid body is provided with a plurality of holding portions for holding the annulus fixing member with a thread,
Here, the yarn is stretched between the plurality of holding portions and penetrates the annulus fixing member,
The holding portion is provided at a predetermined interval on a circumference formed by the rigid body,
The annulus fixing member is
Annular,
Circumscribing the rigid body and surrounding the rigid body, and
Have flexibility,
Heart annulus fixed surgical ring. The rigid body has a circumference;
The holding portions are respectively provided at positions that divide the circumference length into six equal parts,
The heart annulus fixed surgical ring according to claim 1. The rigid body has a circumferential concave surface toward the outside of the circumference formed by the rigid body,
The holding portion is a through hole formed at the bottom of the concave surface and penetrating the rigid body between the outer side and the inner side of the circumference.
The holding portion is configured to hold the annulus fixing member on the rigid body using a thread that penetrates the through hole and the annulus fixing member.
The heart annulus fixation surgical ring according to claim 1 or 2. The holding portion is a groove formed along a surface intersecting a circumference formed by the rigid body;
The holding portion is configured to hold the annulus fixing member on the rigid body using a thread wound around the groove and penetrating the annulus fixing member.
The heart annulus fixation surgical ring according to claim 1 or 2. The rigid body is circumferential,
The outer diameter of the circumference is 16 mm or more and 28 mm or less,
The heart annulus fixed surgical ring according to any one of claims 1 to 4. A heart annulus fixation surgical ring and an annulus fixation member;
The heart valve annulus surgical ring is
An annular rigid body,
The rigid body is provided with a plurality of holding portions for holding the annulus fixing member with a thread,
Here, the yarn is stretched between the plurality of holding portions and penetrates the annulus fixing member,
The holding portion is provided at a predetermined interval on a circumference formed by the rigid body,
The annulus fixing member is
Seamless closed ring with smooth outer surface,
Circumscribing the rigid body and surrounding the rigid body, and
Have flexibility,
Heart annulus fixation surgical assembly. The rigid body has a circumference;
The holding portions are respectively provided at positions that divide the circumference length into six equal parts,
The cardiac annulus fixation surgical assembly according to claim 6. The rigid body has a circumferential concave surface toward the outside of the circumference formed by the rigid body,
The holding portion is a through hole formed at the bottom of the concave surface and penetrating the rigid body between the outer side and the inner side of the circumference.
The annulus fixing member is wound around the concave surface,
The thread holds the annulus fixing member on the rigid body in a state where the annulus fixing member is sewn onto the rigid body while passing through the through hole.
The cardiac annulus fixation surgical assembly according to claim 6 or 7. The holding portion is a groove formed along a surface intersecting a circumference formed by the rigid body;
The thread holds the annulus fixing member on the rigid body in a state where the annulus fixing member is sewn onto the rigid body while being wound around the groove.
The cardiac annulus fixation surgical assembly according to claim 6 or 7. The rigid body is circumferential,
The outer diameter of the circumference is 16 mm or more and 28 mm or less,
The cardiac annulus fixation surgical assembly according to any one of claims 6 to 9. The annulus fixing member is composed of an ePTFE sheet provided with a reinforcing film,
The cardiac annulus fixation surgical assembly according to any one of claims 6 to 10. The axial length of the annulus fixing member is longer than the axial length of the heart annulus fixing surgical ring, thereby forming a sewing margin.
The cardiac annulus fixation surgical assembly according to any one of claims 6 to 11.

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