JP6800472B2 - Artificial valve annulus - Google Patents

Description

The present invention relates to an artificial valve annulus.

There are four main valves in the heart (tricuspid valve, pulmonary valve, mitral valve, aortic valve). These valves are composed of an annulus and a leaflet connected to the annulus, each of which acts as a door for blood to flow in a certain direction. A condition in which these valves do not work sufficiently due to various causes is called valvular heart disease.

Valvular heart disease is stenosis, which is a condition in which the valve opens poorly and blood does not easily flow out of the heart chamber. The valve closes poorly and the extruded blood returns to the original heart. There is a condition of insufficiency.

For patients with valvular heart disease, especially mitral valve and tricuspid valve insufficiency, valvuloplasty with sutures and artificial chordae tendineae is performed to prevent re-expansion of the treated annulus. An annulus is used. So far, various artificial valve rings have been developed and used (for example, Patent Documents 1 to 3).

Japanese Patent Application Laid-Open No. 2007-535371 Japanese Patent Publication No. 2008-528179 Japanese Patent Publication No. 2011-520505

The shape of the annulus is different for each patient. The artificial annulus of Patent Documents 1 to 3 and the like is sutured while adjusting the shape of the annulus of the patient at the time of suturing. However, it is not easy even for a skilled operator to match the shape of the patient's annulus while suturing the artificial annulus.

The present invention has been made in view of the above matters, and an object of the present invention is to provide an artificial annulus that can be deformed into a shape corresponding to the shape of a patient's valve leaflet and annulus during surgery. To do.

The artificial valve annulus according to the present invention
Deformable heat conductive member and
A shape-retaining member made of a thermoplastic resin, which covers the heat conductive member or is arranged by being covered with the heat conductive member.
The shape-retaining member or the film formed over the heat conductive member is provided.
The heated heat conductive member softens the shape-retaining member so that it can be deformed into a shape corresponding to the patient's annulus, is formed into a predetermined shape, is cooled, and then is cured to retain the formed shape. To do,
It is characterized by that.

Further, it is preferable that the shape-retaining member is made of the thermoplastic resin that softens at 50 ° C to 70 ° C.

Further, the thermoplastic resin may be polycaprolactone.

Further, the heat conductive member may be formed in a coil shape.

Further, the heat conductive member may be a heat transfer wire that generates heat by supplying electric power.

Further, the heat conductive member may be a tubular body through which a thermal fluid passes.

Further, the tubular body may be provided with a hole.

Further, the tubular body may be formed by spirally winding a band-shaped material.

Both ends of the heat conductive member are arranged so as to protrude or sink from the film.
A covering member that covers the end portion of the heat conductive member may be provided.

The artificial annulus according to the present invention can be deformed into a shape corresponding to the shape of the patient's valve leaflet and the annulus during the operation.

It is a perspective view which shows the appearance of the artificial valve annulus. It is a figure which shows the internal structure of the artificial valve annulus, FIG. 2A is a cross-sectional view taken along the line AA'in FIG. 1, and FIG. 2B is a cross-sectional view taken along the line B-B'in FIG. 3 (A) to 3 (C) are views showing the deformation of the artificial valve annulus. It is a figure which shows the state that the covering member is installed at both ends of the heat conduction member. It is a figure which shows the state that the covering member is installed at both ends of the heat conduction member. It is sectional drawing of the artificial valve annulus which concerns on other forms. It is a partial cross-sectional view of the artificial valve annulus which concerns on other forms. It is sectional drawing of the artificial valve annulus which concerns on other forms. It is a partial perspective view of the heat conduction member which concerns on other forms. It is a partial perspective view of the heat conduction member which concerns on other forms.

As shown in FIGS. 1, 2 (A) and 2 (B), the artificial valve annulus according to the present embodiment includes a heat conductive member 10, a shape-retaining member 20, and a coating film 30.

The heat conductive member 10 is covered with a shape-retaining member 20 except for both ends. The heat conductive member 10 has a function of transferring heat to the shape holding member 20 to heat the shape holding member 20. The heat conductive member 10 is, for example, a heating wire. Wiring is connected to both ends of the heat conductive member 10 to receive electric power and generate heat. Then, the heat is transferred to the shape-retaining member 20 to heat the shape-retaining member 20.

Examples of the heat transfer wire include metals such as stainless steel, nichrome, and tungsten. Further, the heat conductive member 10 is a material that can be deformed by an operator's hand.

The shape-retaining member 20 is made of a thermoplastic resin. The shape-retaining member 20 is softened by heat and becomes deformable, and can be formed into a predetermined shape. The shape-retaining member 20 has a property of being cured after being cooled and retaining the molded shape. The shape-retaining member 20 is thermoplastic so that it can be softened and molded at about 50 ° C. to 70 ° C. so that the operator can hold it in his hand and mold it at the time of softening, and further soften it at blood temperature and not deform it. Resin is used.

Examples of the above-mentioned thermoplastic resin include polycaprolactone. Polycaprolactone is a material that is also used as a medical material, and has a low melting point of about 60 ° C., and is softened and deformable even at about 50 ° C.

The film 30 completely covers the shape-retaining member 20 except for both ends of the heat conductive member 10. The film 30 functions to prevent the shape-retaining member 20 from flowing out even if the shape-retaining member 20 melts.

The coating 30 also preferably has a function of facilitating suturing the artificial valve annulus 1 to the patient's annulus. Therefore, the film 30 is preferably made of a material capable of penetrating the suture needle and suture. For example, it is composed of a membrane formed of biocompatible artificial fibers such as polyethylene terephthalate fiber represented by Dacron (registered trademark).

The artificial valve annulus 1 is obtained, for example, as follows. A C-shaped heat conductive member 10 is arranged on the mold, and the melted shape-retaining member 20 is poured into the mold to be cooled. Then, the artificial valve annulus 1 can be obtained by coating the film 30 around the shape-retaining member 20.

Alternatively, the heat conductive member 10 may be immersed in the melted shape-retaining member 20, and the shape-retaining member 20 may be attached around the heat-conducting member 10 to be cooled.

Subsequently, a usage pattern of the artificial valve annulus 1 will be described. From the state shown in FIG. 3A, wiring is connected to both ends of the heat conductive member 10 to supply electric power. Due to the power supply, the heat conductive member 10 composed of the heating wire generates heat.

The heat generated by the heat conductive member 10 is transferred to the shape holding member 20, and the shape holding member 20 is softened. When the shape-retaining member 20 softens, the operator molds it, for example, as shown in FIG. 3 (B). Here, the surgeon forms the artificial valve annulus 1 into a shape corresponding to the annulus of the patient. Then, when the power supply is stopped and the artificial valve annulus 1 is cooled, the shape-retaining member 20 is cured, and the artificial valve annulus 1 retains the formed shape.

Then, the operator sutures the molded artificial annulus 1 to the annulus of the patient. Since the artificial valve annulus 1 has a shape corresponding to the annulus of the patient, the operator can easily suture it. Further, after the artificial valve annulus 1 is sutured to the patient's annulus, electric power can be supplied to deform the artificial annulus ring 1.

As described above, since the artificial valve annulus 1 can be molded three-dimensionally, it can be realized to be molded into a shape suitable for each patient.

The shape-retaining member 20 can be repeatedly softened and cured. Therefore, when the molded artificial valve annulus 1 does not slightly match the shape of the patient's annulus, for example, from the shape shown in FIG. 3 (B) to the shape shown in FIG. 3 (C) by the same method as described above. Can be molded again. Since the molding can be redone, the artificial valve annulus 1 is not wasted even if the molding fails.

Further, as shown in FIGS. 4 and 5, coating materials 40 may be installed and fixed at both ends of the heat conductive member 10 protruding from the film 30. The covering material 40 is provided with holes having an inner diameter substantially the same as the outer shape of the heat conductive member 10. Examples of the fixing of the covering material 40 include fixing by caulking and fixing by an adhesive.

In the above description, an example in which both ends of the heat conductive member 10 protrude from the film 30 has been described, but as shown in FIG. 6, both ends of the heat conductive member 10 are recessed from the film. May be good.

Further, as shown in FIG. 7, the heat conductive member may have a coil shape. Since the coiled heat conductive member 10 is flexibly deformed, the artificial valve annulus 1 can be easily formed. Further, since the surface area of the heat conductive member 10 is large due to the coiled shape, heat can be effectively transferred to the shape holding member 20, and the time until the shape holding member 20 softens can be shortened.

Further, in the above description, as the heat conductive member 10, a heating wire has been described as an example, but the heat generated by the heat conductive member 10 or the heat from the heat conductive member 10 heated by an external heat source is transferred to the shape holding member 20. Any configuration may be used as long as it can be conveyed to.

For example, as shown in FIG. 8, as an example of the other heat conductive member 10, a tubular body through which a fluid can pass may be used. As shown by the arrow in FIG. 4, the heat conductive member 10 has a hot fluid such as hot water or hot water (for example, 60 ° C. to 100 ° C.) flowing in from one end and discharged from the other end. To. The heat conductive member 10 is heated by heat exchange with the thermal fluid, and the heat is transferred to the shape holding member 20. The tubular heat conductive member 10 may be made of a biocompatible material having heat resistance of about 100 ° C. such as polyethylene terephthalate.

Further, in the form in which the thermal fluid flows in, as shown in FIG. 9, the heat conductive member 10 may be provided with a plurality of holes 11. The heat fluid can directly transfer the heat to the shape-retaining member 20 through the holes 11. As a result, heat transfer can be performed more effectively, and the time until the shape-retaining member 20 softens can be shortened. Further, since the heat conductive member 10 is provided with a plurality of holes 11, the flexibility of the heat conductive member 10 is also improved, and the heat conductive member 10 is easily deformed. Therefore, the artificial valve annulus 1 can be easily formed.

Further, in the form in which the thermal fluid flows in, as shown in FIG. 10, the heat conductive member 10 formed by spirally winding the strip-shaped material may be used. If the strip-shaped material is formed by being spirally wound, it is easily deformed, so that the artificial valve annulus 1 can be easily formed.

1 Artificial valve annulus 10 Heat conductive member 11 Hole 20 Shape holding member 30 Coating 40 Coating material

Claims (9)

Deformable heat conductive member and
A shape-retaining member made of a thermoplastic resin, which covers the heat conductive member or is arranged by being covered with the heat conductive member.
The shape-retaining member or the film formed over the heat conductive member is provided.
The heated heat conductive member softens the shape-retaining member so that it can be deformed into a shape corresponding to the patient's annulus, is formed into a predetermined shape, is cooled, and then is cured to retain the formed shape. To do,
An artificial valve annulus characterized by that. The shape-retaining member is composed of the thermoplastic resin that softens at 50 ° C to 70 ° C.
The artificial valve annulus according to claim 1. The thermoplastic resin is polycaprolactone.
The artificial valve annulus according to claim 2. The heat conductive member is formed in a coil shape.
The artificial valve annulus according to any one of claims 1 to 3, wherein the artificial valve annulus is characterized in that. The heat conductive member is a heating wire that generates heat due to power supply.
The artificial valve annulus according to any one of claims 1 to 4, wherein the artificial valve annulus is characterized. The heat conductive member is a tubular body through which a thermal fluid passes.
The artificial valve annulus according to any one of claims 1 to 3, wherein the artificial valve annulus is characterized in that. The tubular body is provided with a hole,
The artificial valve annulus according to claim 6. The tubular body is formed by spirally winding a band-shaped material.
The artificial valve annulus according to claim 6. Both ends of the heat conductive member are arranged so as to protrude or sink from the film.
A covering member that covers an end portion of the heat conductive member is provided.
The artificial valve annulus according to any one of claims 1 to 8, wherein the artificial valve annulus is characterized.

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