WO2010067463A1

WO2010067463A1 - Instrument for capturing tissue piece to be used in aortic valve replacement surgery and method of capturing tissue piece in aortic valve replacement surgery

Info

Publication number: WO2010067463A1
Application number: PCT/JP2008/072898
Authority: WO
Inventors: 裕啓柳; 澤田眞一
Original assignee: 株式会社カルディオ
Priority date: 2008-12-10
Filing date: 2008-12-10
Publication date: 2010-06-17

Abstract

Disclosed is an instrument for capturing a tissue piece to be used in aortic valve replacement surgery which can close the aortic valve before removing the valve cusps. An instrument for capturing a tissue piece to be used in aortic valve replacement surgery which can prevent the invasion of the residue of a tissue piece, which is formed in association with the removal of the aortic valve in a surgery for replacing the heart aortic valve, into the left ventricle. This instrument for capturing a tissue piece can be in a contracted state with a shape and size allowing the passage of the same through the space among the aortic valve cusps from the aortic side to the left ventricle side as well as in a dilated state with a shape and size allowing the placement of the same in the vicinity of the aortic valve rings in the left ventricle so as to close the aortic valve. Prior to the surgery for replacing the heart aortic valve, the instrument in the contracted state is passed through the space among the aortic valve cusps from the aortic side to the left ventricle side. After introducing into the left ventricle, the instrument is made into the dilated state so as to close the aortic valve in the vicinity of the aortic valve rings in the left ventricle. Thus, it becomes possible to prevent the invasion of the residue of a tissue piece into the left ventricle.

Description

Tissue fragment capture tool for aortic valve replacement surgery and tissue fragment capture method in aortic valve replacement surgery

The present invention relates to a tissue piece capturing tool for aortic valve replacement surgery for suppressing the invasion of a tissue piece remnant that may be generated by aortic valve resection in an aortic valve replacement operation, and a tissue piece for aortic valve replacement surgery. The present invention relates to a capturing device set and a tissue fragment capturing method in aortic valve replacement surgery.

In the prior art, aortic valve replacement surgery is widely performed as a treatment for aortic stenosis or aortic regurgitation caused by aortic valvular disease.
The aortic valve replacement operation refers to an operation in which the aortic valve is removed and replaced with a mechanical valve or a biological valve introduced from the outside in order to treat aortic stenosis or aortic regurgitation caused by aortic valvular disease.
Aortic valvular disease refers to a state in which the aortic valvular membrane hinders opening and closing movements, and when it develops, the blood transfusion efficiency of the heart decreases. In principle, it is considered a serious disease requiring surgical treatment.
Aortic stenosis refers to a condition where the opening of the aortic valve is not successful, and aortic valve insufficiency refers to a condition where the closure is not successful.
At the time of aortic valve replacement surgery, the aortic valve is resected from an incision made by previously incising the ascending aortic wall near the leaflet of the aortic valve. In aortic valve replacement surgery, when aortic valve is excised, a minute tissue fragment residue may be generated, and the tissue fragment residue generated by the excision may enter the ventricle. If the tissue piece has entered the ventricle, if the operation is completed as it is, the tissue piece will remain in the ventricle or other organs. In particular, if a tissue piece moves on the bloodstream and moves into other organs after surgery, it may cause dangerous complications such as cerebral infarction. Therefore, it is necessary to perform a treatment for preventing the tissue piece residue from entering the ventricle and a treatment for discharging the tissue piece that has entered the ventricle. For example, gauze or the like captured by a tissue fragment residue is blocked by packing it near the aortic valve annulus in the ventricle.
JP-T-2002-527157 Publication JP-T-2005-503197 Publication

In the above-described treatment using the capture device, it is necessary to introduce a capture device such as gauze from the leaflet side of the aortic valve to the annulus side of the aortic valve. The size of the capture device such as gauze needs to be sufficient to block the aortic valve. The maximum inner diameter on the annulus side of the aortic valve is approximately 15 to 25 mm for adults. That is, it is necessary to use a capturing tool having a size of 15 to 25 mm. However, the gap between the leaflets of the aortic valve is generally 3 to 7 mm when the maximum length is an adult. Therefore, the capturing device such as gauze cannot pass through the gap between the leaflets as it is. Therefore, in order to introduce a capture device such as gauze from the leaflet side of the aortic valve to the annulus side of the aortic valve, it is necessary to provide an introduction path in advance by excising one or more leaflets. However, tissue fragment residue may also occur during valve leaflet excision to secure the introduction route, so that the tissue fragment residue may enter the ventricle before the introduction of the capture device such as gauze is completed. There was a problem.
In view of the above problems, the present invention provides a tissue piece capturing device for aortic valve replacement surgery that can close the aortic valve before excising the leaflets, a tissue piece capturing device set for aortic valve replacement surgery, and aortic valve replacement. An object of the present invention is to provide a method for capturing a tissue piece in an operation.

In order to achieve the above object, a tissue fragment capturing tool for aortic valve replacement surgery according to the present invention comprises:
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; An expanded state having a size, and prior to the replacement operation of the aortic valve, the aortic valve leaflet is passed from the aorta side toward the left ventricle side in the contracted state, and after the introduction of the left ventricle In the expanded state, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue piece residue is prevented from entering the left ventricle.
There may be various means for switching from the contracted state to the expanded state.
For example, there is means for switching from the contracted state to the expanded state using air pressure. For example, it is composed of a film-like material and inflates like a so-called balloon by injecting air.
Further, for example, there is means for switching from the contracted state to the expanded state by absorbing liquid and expanding. As a means for inflating, the whole is made of an inflatable material that expands by absorbing liquid, and can be changed from a contracted state to an expanded state by absorbing liquid. As another means for inflating, the structure includes an inflatable material that expands by absorbing liquid, and a sheet-like capturing portion that wraps the inflatable material, and the inflatable material absorbs the liquid. The contracted state can be changed to the expanded state.
In addition, for example, a sheet-like capture unit that captures the tissue piece and a movable support unit that supports and deforms the capture unit, and by deforming the capture unit through operation of the support unit, There is means for switching from the contracted state to the expanded state. As one configuration example, the support portion is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capture portion is a cloth material covering the periphery of the brush. As another configuration example, the support portion is a plurality of disc-shaped brushes provided with hair material radially from the center toward the outer periphery, and the capturing portion is a disc-shaped brush inserted between the brushes. It is a cloth material. As the means for deforming the capturing part by operating the support part, the contraction state of the brush of the support part is a state where the disk-like brush is closed in an umbrella shape, and the expansion state is the disk-like brush. There is a means to make it open like an umbrella.
With the above configuration, it is not necessary to resect one or more leaflets before placing the tissue piece capturing device in the conventional manner, and the capturing device is inserted through the gap between the aortic valve leaflets and the aortic valve annulus in the left ventricle. Since the tissue piece can be introduced to the side and the tissue piece is not generated before the capture tool is introduced, the tissue piece associated with the leaflet resection can be more reliably captured without leakage.
The technique using the tissue piece capturing device of the present invention is a new concept tissue piece capturing method that has never been known before, and there is no example that discloses such a capturing device. In the contracted state, the aortic valve gap of 3 to 7 mm can be inserted, and in the expanded state, the inner diameter of the 15 to 25 mm aortic valve on the annulus side can be closed.
Further, in the tissue piece capturing tool for aortic valve replacement surgery, a structure having a thread-like, tubular or rod-like recovery tool is provided, and one end of the recovery tool is left on the aorta side before and after the aortic valve replacement surgery. It is preferable that after the aortic valve replacement operation, one end of the recovery tool is pulled to pass through the aortic valve to enable recovery from the aortic side.
With the above configuration, when the aortic valve replacement operation is completed, it can be easily and reliably collected from the patient's heart to the outside.
Next, the tissue piece capturing tool set for aortic valve replacement surgery of the present invention,
A tubular member introducer having an outer diameter capable of passing through the gap of the aortic valve leaflet;
A tissue piece capturing device comprising a contracted state having a shape and size capable of passing through the inside of the introducer, and an expanded state having a shape and size that fits in the vicinity of the aortic valve annulus in the left ventricle and closes the aortic valve When,
An opening tool that pushes out the tissue piece capturing tool housed inside the introduction tool and releases it from the tubular member;
Prior to the replacement operation of the aortic valve, the introducer that houses the tissue piece capturing device in the contracted state is introduced into the gap of the aortic valve leaflet so that the left ventricle side from the aorta side. The aorta is secured by allowing the tissue piece capturing device to be pushed out by the opening device and passing through the inside of the introducing device, and after the tissue piece capturing device is introduced into the left ventricle, the expanded state is established. The aortic valve is closed in the vicinity of the annulus to prevent the tissue fragment residue from entering the left ventricle.
With the above configuration, the tissue piece capturing tool of the present invention can be quickly placed in a predetermined position, and the operation time can be shortened.
Next, the tissue fragment capturing method in the aortic valve replacement surgery of the present invention,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; Using a tissue piece capture device with an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the tissue piece capturing device is passed through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side in the contracted state, and the expanded state after the introduction of the left ventricle Thus, the aortic valve is closed in the vicinity of the aortic annulus, and the tissue fragment residue is prevented from entering the left ventricle.

FIG. 1 is a diagram showing an expanded state of a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a. FIG. 2 is a configuration example of a wide, substantially cylindrical, solid-shaped tissue piece capturing device 10a. FIG. 3 is a diagram showing another contracted state of the tissue piece capturing device 10a. FIG. 4 is a diagram showing an expanded state of a configuration example of the spherical three-dimensional tissue piece capturing device 10b. FIG. 5 is a diagram showing a contracted state of the configuration example of the spherical solid-shaped tissue piece capturing tool 10b. FIG. 6 shows an expanded state of the configuration example of the substantially bowl-shaped three-dimensional tissue piece capturing tool 10c. FIG. 7 is a diagram showing a contracted state of a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing device 10c. FIG. 8 is a configuration example of a conical substantially scissor-shaped tissue piece capturing device 10d. FIG. 9 is a diagram showing a contracted state of a configuration example of the cone-shaped substantially scissor-shaped tissue piece capturing tool 10d. FIG. 10 is a diagram showing an expanded state of a configuration example of a substantially donut-shaped capturing tool 10e whose central portion is closed with a membrane. FIG. 11 is a diagram where the central portion is closed with a membrane. FIG. 12 is a diagram showing a contracted state of a configuration example of a substantially donut-shaped three-dimensional capturing device 10e. FIG. 12 is a diagram showing a contracted state of a tissue piece capturing device 10c by applying air pressure. FIG. 14 is a diagram showing a configuration example in which the tissue piece capturing tool 10c is switched from the contracted state to the expanded state. FIG. 14 is a diagram showing the contracted state of the tissue piece capturing tool 10e shown in FIG. FIG. 16 is a diagram showing a configuration example of switching from the contracted state of the tissue piece capturing tool 10e shown in FIG. 11 to the expanded state of the tissue piece capturing tool 10e shown in FIG. 11. FIG. 16 shows the contraction of the tissue piece capturing tool 10a shown in FIG. Shown in Figure 2 from the state FIG. 17 is a diagram showing a configuration example of switching to the expanded state of the tissue piece capturing tool 10a. FIG. 17 switches from the contracted state of the tissue piece capturing tool 10a shown in FIG. 3 to the expanded state of the tissue piece capturing tool 10a shown in FIG. Fig. 18 is a diagram showing a configuration example. Fig. 18 is a diagram showing a configuration example for switching from the contracted state of the tissue piece capturing device 10d shown in Fig. 9 to the expanded state of the tissue piece capturing device 10d shown in Fig. 8. FIG. 20 is a diagram showing a configuration example in which the tissue piece capturing section 10 is deformed through operation of the support section. FIG. 20 shows a state in which the entire tissue piece capturing tool 10f is contracted by contracting the support ring 15 to the left and right. FIG. 21 is a diagram showing another configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit. FIG. 22 shows a state in which the support balloon 17 is deflated by removing air. It is a figure showing typically FIG. 24 is a diagram showing an expanded state of a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h. FIG. 24 is a diagram showing a contracted state of a configuration example of the brush-shaped three-dimensional tissue piece capturing tool 10h. FIG. 25 is a diagram showing an expanded state of the configuration example of the brush-shaped three-dimensional tissue piece capturing tool 10h ′ in which the hair material is covered with the cloth material. FIG. 26 is a brush-like shape in which the hair material is covered with the cloth material. FIG. 27 is a diagram showing a contracted state of a configuration example of a three-dimensional tissue piece capturing device 10h ′. FIG. 27 is a diagram showing an expanded state of a configuration example of a tissue piece capturing device 10h ″ in which a cloth material is sandwiched between bristle materials. FIG. 28 is a diagram schematically showing an exploded view of two bristle materials of the tissue piece capturing tool 10h ″ and a cloth material sandwiched between them. FIG. 29 is a diagram of FIG. It is a figure which shows the structure provided with the collection | recovery tool 30 with respect to the tissue piece capturing tool 10a which is the substantially cylindrical solid shape shown FIG. 30 is a view showing a configuration in which the recovery tool 30 is provided for the tissue piece capturing tool 10f with the support ring 15 shown in FIG. 19 of the first embodiment. FIG. 31 shows the tissue piece capturing tool 10f as the introduction tool 40. FIG. 32 is a view showing a state in which the tissue piece capturing tool 10f is released by pushing it from the inside of the introduction tool 40 to the outside through the release side opening 41. FIG. FIG. 34 is a view showing a state in which the tissue piece capturing tool 10f is accommodated in the introduction tool 40. FIG. 34 is a diagram showing that the tissue piece capturing tool 10f is pushed out from the introduction tool 40 to the outside through the release side opening 41. FIG. 35 is a view showing a released state. FIG. 35 is a view showing a state in which the tissue piece capturing tool 10g is accommodated in the introduction tool 40. FIG. 36 is a view showing the tissue piece capturing tool 10g from the inside of the introduction tool 40. Outside through the opening 41 FIG. 37 is a view showing a state where the tissue piece capturing device 10 is pushed out by the push-out rod 50 as the opening device 50. FIG. 38 is a view showing the leaflet of the aortic valve. FIG. 39 is a diagram showing a procedure for dissecting the ascending aortic wall in the vicinity and providing an incision. FIG. 39 passes the space 4 of the leaflet of the aortic valve 3 and introduces the introducer 40 up to the annulus 6 of the aortic valve 3. FIG. 40 is a diagram showing a procedure for closing the aortic valve 3 by placing the tissue piece capturing device 10 in an expanded state and placing it in the vicinity of the aortic valve annulus. FIG. 41 is a diagram showing the introducing device 40. It is a figure which shows the procedure which takes out from the incision to the exterior of the ascending aorta

Hereinafter, the best mode for carrying out the present invention will be described specifically by way of examples. The present invention is not limited to these examples.
Hereinafter, the tissue piece capturing device for aortic valve replacement surgery, the tissue piece capturing device set for aortic valve replacement surgery, and the tissue piece capturing method in aortic valve replacement surgery according to the present invention will be described in detail with reference to the preferred embodiments shown in the accompanying drawings. Explained. The present invention is not limited to these examples.
The tissue piece capturing device for aortic valve replacement surgery of the present invention suppresses invasion of a tissue piece residue into the left ventricle that may be caused by excision of the aortic valve in aortic valve replacement surgery.
Hereinafter, first, as Example 1, various structure examples of the tissue piece capturing tool 10 for aortic valve replacement surgery and a structure for switching between an expanded state and a contracted state of the tissue piece capturing tool will be described.
As a second embodiment, a configuration example of the tissue piece capturing tool 10 with the recovery tool 30 is shown.
As Example 3, an operation procedure for placing and removing the tissue piece capturing device 10 at a predetermined position of the ventricle using the introducing device 40 and the opening device 50 will be described.

Various shape examples of the tissue piece capturing tool 10 for aortic valve replacement surgery according to the first embodiment will be specifically described with reference to the accompanying drawings.
First, an example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a is shown. FIG. 1 and FIG. 2 are diagrams showing a configuration example of a wide, substantially cylindrical three-dimensional tissue piece capturing tool 10a. FIG. 1 shows an expanded state of the tissue piece capturing tool 10a, and FIG. 2 shows a contracted state of the tissue piece capturing tool 10a. 1 and 2, (a) is a front view, (b) is a side view, and (c) is a perspective view.
The shape and size of the tissue piece capturing device 10a in the expanded state are not particularly limited as long as the shape and size are close to the aortic valve annulus in the left ventricle of the patient and close the aortic valve, but the size is not limited. Has a diameter of 10 to 30 mm and a height of 1 to 30 mm. During the operation, since the ventricle is closed and the capturing device 10a cannot enter, if the height is too high, the capturing device 10 will be located in the vicinity of the aortic valve, and the operation such as excision of the valve leaflet will be performed. When working, the work space is compressed and obstacles occur. Therefore, about 1 to 30 mm is preferable.
In the example of the tissue piece capturing tool 10a according to the first embodiment, as shown in FIG. 1, the shape is a wide, substantially cylindrical three-dimensional shape, and the edge portion is a smooth curved surface. Has been. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
Next, the shape and size of the tissue piece capturing device 10a in the contracted state are not limited as long as the shape and size can pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side. In the example of the tissue piece capturing tool 10a according to No. 1, as shown in FIG. 2, the shape is a thin cylindrical solid shape, and the edge portion is a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 3 to 7 mm in height.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10a of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10a of the present invention can pass through in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10a cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10a of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed and the tissue piece residue is captured in a substantially cylindrical internal void.
In this way, prior to the aortic valve replacement operation, the tissue piece capture device 10a can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
FIG. 3 is an example of another contracted state of the tissue piece capturing tool 10a. A part of the expanded state of FIG. 1 is contracted and the other part is expanded to be contracted. That is, although the outer diameter of the substantially cylindrical shape is reduced from the expanded state of FIG. 1, the height is increased and the whole is contracted into a compact shape.
The shape of the tissue piece capturing tool 10 of the present invention is not limited to that shown in FIGS. 1 and 2 or those shown in FIGS. 1 and 3, and various other shapes and sizes are possible.
Next, an example of a spherical three-dimensional tissue piece capturing tool 10b is shown. 4 and 5 are diagrams showing a configuration example of a spherical solid-shaped tissue piece capturing tool 10b. 4 shows an expanded state of the tissue piece capturing tool 10b, and FIG. 5 shows a contracted state of the tissue piece capturing tool 10b. 4 and 5, (a) is a front view, and (b) is a side view.
In this example, as shown in FIG. 4, the capturing tool 10b has a spherical three-dimensional shape in the expanded state, has a shape and a size that fits in the vicinity of the aortic valve annulus, and closes the aortic valve. . Note that the shape of the capturing device 10b does not necessarily have an accurate spherical shape, and even the non-spherical capturing device 10b may have a shape and size that can be accommodated in the vicinity of the aortic valve annulus. For example, the diameter of the sphere is 10 to 30 mm.
Further, in this example, as shown in FIG. 5, the capturing tool 10b has a thin cylindrical solid shape in a contracted state, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in height.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10b of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing device 10b of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing tool 10b cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue fragment capturing device 10b of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. Capture tissue debris.
As described above, prior to the replacement operation of the aortic valve, the tissue piece capturing tool 10b can block the aortic valve so as to surround the annulus of the aortic valve, thereby preventing the tissue piece residue from entering the left ventricle.
Next, an example of a substantially scissor-shaped three-dimensional tissue piece capturing tool 10c will be described. 6 and 7 are diagrams showing a configuration example of a substantially scissor-shaped three-dimensional tissue piece capturing tool 10c. FIG. 6 shows the expanded state of the tissue piece capturing tool 10c, and FIG. 7 shows the contracted state of the tissue piece capturing tool 10c. 6 and 7, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 6, the capturing tool 10c has a substantially bowl-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus, and has a substantially bowl-like shape. The mouth closes the aortic valve. For example, the diameter of the ridge is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
In this example, as shown in FIG. 7, the tissue piece capturing tool 10c has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl shape inside. The edge portion is disclosed as a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in length.
Prior to the aortic valve replacement operation, the tissue piece capturing device 10c of the present invention passes the gap between the aortic valve leaflets from the aorta side to the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10c of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10c cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10c of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. The aortic valve is closed, and the tissue debris is captured in the internal cavity of a generally saddle shape.
In this way, prior to the aortic valve replacement operation, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10c.
Note that the shape of the tissue piece capturing tool 10 is not necessarily a substantially hemispherical bowl shape, and may be, for example, a conical substantially bowl shape. FIG. 8 and FIG. 9 are diagrams showing a configuration example of a cone-shaped substantially scissor-shaped tissue piece capturing tool 10d. FIG. 8 shows an expanded state of the tissue piece capturing tool 10d, and FIG. 9 shows a contracted state of the tissue piece capturing tool 10d. 8 and 9, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 8, the tissue piece capturing tool 10d has a conical substantially saddle-like three-dimensional shape in the expanded state, and has a shape and a size that fit in the vicinity of the aortic valve annulus. The aortic valve is closed by a shaped mouth. For example, the diameter of the ridge is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
In this example, as shown in FIG. 9, the trapping tool 10 d has a three-dimensional shape with a thin cylindrical shape in the contracted state and a bowl-like shape inside. In this example, the shape is almost the same as that in FIG. 7, and the edge portion has a smooth curved surface. This is a device for reducing contact with tissue at the time of introduction into the body, but it is not essential to adopt such a shape. The size is 3 to 7 mm in diameter and 10 to 30 mm in length.
Prior to the aortic valve replacement operation, the tissue piece capturing tool 10d of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10d of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10d cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10d of the present invention passes through the gap of the aortic valve leaflet and introduces the left ventricle, and then enters the expanded state of FIG. The valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
In this way, prior to the aortic valve replacement surgery, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10d.
Next, an example of a substantially doughnut-shaped three-dimensional tissue piece capturing tool 10e having a central portion closed with a membrane will be described. FIG. 10 and FIG. 11 are diagrams showing a configuration example of a substantially donut-shaped three-dimensional capturing tool 10e whose central portion is closed with a membrane. FIG. 10 shows an expanded state of the tissue piece capturing tool 10e, and FIG. 11 shows a contracted state of the tissue piece capturing tool 10e. 10 and 11, (a) is a front view, (b) is a side view, (c) is a side sectional view, and (d) is a perspective view.
In this example, as shown in FIG. 10, the tissue piece capturing device 10e has a substantially donut-shaped three-dimensional shape in which the central portion is closed with a membrane in the expanded state, and has a shape and size that fits in the vicinity of the aortic valve annulus. The aortic valve is blocked. For example, the outer diameter of the donut is 10 to 30 mm. The edge portion is disclosed as a smooth curved surface. This is a device for softening contact with human tissue when the aortic valve is closed, but it is not essential to adopt such a shape.
Moreover, in this example, as shown in FIG. 11, the contracted state of the capturing tool 10e has a three-dimensional shape that is entirely contracted from the expanded state of FIG. The outer diameter of the donut is 3 to 7 mm. In addition, since the whole is a curved surface, contact with a tissue is eased at the time of introduction into the body.
Prior to the aortic valve replacement operation, the tissue piece capturing tool 10e of the present invention passes the gap between the aortic valve leaflets from the aorta side toward the left ventricle side in the contracted state of FIG. The gap between the aortic valve leaflets is about 3 to 7 mm, and the tissue piece capturing tool 10e of the present invention can pass in the contracted state of FIG. If the gap between the aortic valve leaflets is small and the tissue piece capturing device 10e cannot pass, the leaflets may be cut to increase the gap. The length of the incision is not limited, but if the maximum length is an incision of about 10 mm or less, there is no possibility of generating a tissue piece when making the incision.
The tissue piece capturing device 10e of the present invention passes through the gap of the aortic valve leaflet and is introduced into the left ventricle, and then enters the expanded state of FIG. 10 so that the aortic valve is surrounded by the portion corresponding to the mouth of the donut. The valve is closed and the tissue debris is captured in a substantially bowl-shaped internal space.
As described above, prior to the replacement operation of the aortic valve, the tissue piece residue can be prevented from entering the left ventricle by closing the aortic valve so as to surround the annulus of the aortic valve with the tissue piece capturing tool 10e.
Next, a structure for switching between the expanded state and the contracted state of the tissue piece capturing device 10 having various shapes will be described.
Although the structure of the tissue piece capturing tool 10 is not limited, the volume can be reduced by a simple operation, and the volume can be increased to the original by a simple operation, for example, by shape recovery by shape memory ability. A structure capable of forming is preferable. As such a structure, for example, a porous structure having shape memory ability or a fiber is preferable.
First, a structure for switching the tissue piece capturing tool 10 from the contracted state to the expanded state by applying air pressure will be described.
12 and 13 are diagrams illustrating a configuration example in which the tissue piece capturing tool 10 is switched from the contracted state to the expanded state by applying air pressure. FIG. 6 is a diagram illustrating a configuration example in which the tissue piece capturing device 10a illustrated in FIG. 4 is switched from the contracted state to the expanded state of the spherical tissue piece capturing device 10a illustrated in FIG. 5 as an example. FIG. 12 shows a contracted state before air pressure is applied to the tissue piece capturing tool 10a. On the other hand, FIG. 13 shows a state in which the tissue piece capturing tool 10a is switched to the expanded state by applying air pressure. Both FIG. 12 and FIG. 13 are shown by side sectional views.
In the configuration example of FIGS. 12 and 13, the tissue piece capturing tool 10 a includes a balloon 11 and an inlet 12 provided in the balloon 11. A pressure supply tube 20 that can apply air pressure to the balloon 11 can be attached to the balloon 11 via the suction port 12.
When introducing from the leaflet side of the aortic valve to the annulus side, the air pressure is decreased as shown in FIG. 12 to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, in the case where the tissue piece capturing device 10a in the state of FIG. 12 is passed through the gap between the leaflets in the horizontal direction in the drawing from the lower side, the tissue piece capturing device 10a is in a contracted state in the traveling direction. Subsequently, the tissue piece capturing device 10a is passed as it is from the aortic valve leaflet side to the annulus side, and introduced into the vicinity of the aortic valve annulus in the left ventricle. Thereafter, as shown in FIG. 13, the aortic valve is closed by inflating the balloon 11 through the pressure feeding tube 20 until the balloon 11 is expanded by applying air pressure to the balloon 11.
Other configuration examples are also shown. 14 and 15 are diagrams showing a configuration example in which the contraction state of the tissue piece capturing device 10e shown in FIG. 10 is switched to the expanded state of the spherical tissue piece capturing device 10e shown in FIG. FIG. 14 shows a state before air pressure is applied to the tissue piece capturing tool 10e. On the other hand, FIG. 15 shows a state in which the tissue piece capturing tool 10e is switched to the expanded state by applying air pressure. 14A is a side sectional view, and FIG. 14B is a perspective view with a part omitted. FIG. 15 shows a side sectional view.
As shown in FIGS. 14 and 15, the tissue piece capturing device 10 e includes a balloon 11 and an inlet 12 provided in the balloon 11. A pressure supply tube 20 that can apply air pressure to the balloon 11 can be attached to the balloon 11 via the suction port 12. Hereinafter, in FIGS. 14A and 15, the left side of the tissue piece capturing tool 10 e is referred to as “lower part”, and the right side of the tissue piece capturing tool 10 e is referred to as “upper part”. As shown in FIGS. 14 and 15, the tissue piece capturing device 10 e has a substantially donut shape with the center closed by a membrane.
At the time of introduction, the air pressure is reduced to a contracted state and passed through the gap of the aortic valve leaflet. Thereafter, the tissue piece capturing tool 10e is passed through the gap of the aortic valve leaflet and introduced to the vicinity of the aortic valve annulus in the left ventricle. Thereafter, the lower part is directed to the aortic valve inflow part side and the upper part is directed to the aortic valve outflow part side, and then the air pressure is applied from the suction port 12 to the balloon 11 through the pressure feeding tube 20 as shown in FIG. To close the aortic valve by inflating to an expanded state.
Although the maximum diameter of the balloon 11 in the expanded state in which air pressure is applied is not limited, it is preferable not to apply excessive pressure in the vicinity of the aortic valve annulus. It is preferable that the maximum diameter of the cross section of the balloon 11 is, for example, about 10 to 30 mm. Although the length from the upper part to the lower part is not limited, since the ventricle is closed during operation and the tissue piece capturing device 10e cannot enter, if the length is too long, the tissue piece capturing device is located in the vicinity of the aortic valve. 10e is located, and the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of the aortic valve leaflet. Therefore, for example, about 1 to 30 mm is preferable.
The material of the balloon 11 is not limited, and examples thereof include silicon resin, fluorine resin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, and various blend materials.
The tissue piece capturing tool 10 may further include a capturing sheet that covers the outer layer of the balloon 11 in order to capture the tissue pieces more efficiently. The structure of such a capture sheet is not limited, but a structure having high affinity with a tissue piece is preferable. As such a structure, for example, a rough surface, a fiber, a nonwoven fabric, or a porous material is preferable. The material of the capture sheet is not limited, and examples thereof include silicon resin, fluororesin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, cellulose, chitosan, and various blend materials.
Next, a structure for switching from a contracted state to an expanded state by absorbing a liquid such as physiological saline will be described.
In this configuration example, a configuration example of the tissue piece capturing tool 10 that includes a plurality of inflatable materials 13 that expand by absorbing a liquid and in which a set of the materials is covered with a water-permeable sheet 14 will be described. In the contracted state of the tissue piece capturing tool 10, the expansion material 13 is in a dry state and the volume is reduced. In the expanded state, the expansion material 13 is in a water-absorbing state and the volume is expanded.
FIG. 16 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 1 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. The upper part of FIG. 16 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid. On the other hand, the lower part of FIG. 16 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid. Both the upper view and the lower view of FIG. 16 are shown by side sectional views.
Although the expansion | swelling raw material 13 will not be limited if it absorbs a liquid and expand | swells, For example, the compressed fiber lump is mentioned. Although a raw material is not limited, For example, a cellulosic fiber is mentioned.
The tissue piece capturing device 10a shown in FIG. 16 is exposed to a liquid such as physiological saline, and the liquid is absorbed by the expansion material 13 through the water permeable sheet 14, so that the three-dimensional ratio is substantially maintained and the tissue piece capturing device 10a is maintained. The volume can be expanded.
If the size of the tissue piece capturing device 10a is large enough to pass through the gap between the leaflets of the aortic valve in the contracted state in which the expansion material 13 is dried, the side of the aortic valve leaflet is set to the advancing direction side. The gap can be passed. Thereafter, by exposing the tissue piece capturing tool 10a to a liquid such as physiological saline to increase the volume, the vicinity of the aortic valve annulus can be closed.
FIG. 17 is a diagram illustrating a configuration example of switching from the contracted state of the tissue piece capturing device 10a illustrated in FIG. 3 to the expanded state of the tissue piece capturing device 10a illustrated in FIG. 1 by absorbing physiological saline. The upper part of FIG. 17 shows a contracted state before the tissue piece capturing tool 10a absorbs the liquid. On the other hand, the lower part of FIG. 17 shows an expanded state after the tissue piece capturing tool 10a has absorbed the liquid. Both the upper view and the lower view of FIG. FIG. 17 shows a tissue piece capturing device by forming a substantially cylindrical bag with a water-permeable sheet 14 that can be reduced, expanded, or folded, and filling the bag with a plurality of inflatable materials 13 that expand by absorbing liquid. It is a figure which shows the example which comprised 10a. The upper part of FIG. 17 is a perspective view showing the tissue piece capturing tool 10a which has been dried to reduce the expanded material 13 and brought into a contracted state. The lower view of FIG. 17 is a perspective view showing the tissue piece capturing tool 10a in an expanded state by absorbing the liquid and expanding the expansion material 13. The water-permeable sheet 14 having a substantially cylindrical shape in the upper part of FIG. 17 is deformed by reducing a part thereof and expanding the other part, and has a substantially cylindrical outer diameter as shown in the lower part of FIG. The height is reduced by expanding.
FIG. 18 is a diagram illustrating a configuration example in which physiological saline is absorbed to switch from the contracted state of the tissue piece capturing device 10d illustrated in FIG. 9 to the expanded state of the tissue piece capturing device 10d illustrated in FIG. 18 shows a contracted state before the tissue piece capturing tool 10d absorbs the liquid. On the other hand, the lower part of FIG. 18 shows an expanded state after the tissue piece capturing tool 10d has absorbed the liquid. Both the upper and lower views of FIG. 18 are shown by side sectional views.
In the contracted state shown in the upper diagram of FIG. 18, the aortic valve can be blocked by passing through the gap between the leaflets of the aortic valve, and then exposing the tissue piece capturing device 10 d to a liquid such as physiological saline and expanding it by absorbing water. it can.
Although the structure of the expansion | swelling raw material 13 is not limited, For example, the compressed fiber lump is mentioned.
Although the raw material of the compressed fiber lump is not limited, For example, a cellulose fiber lump is mentioned. The size of the compressed fiber lump when dried is preferably about 1 mm to 7 mm. Although the size when the liquid is absorbed and expanded is not limited, for example, in the case of a cellulosic fiber lump, the volume increases about three times as compared with the time of drying.
Although the structure of the water-permeable sheet 14 is not limited, For example, a nonwoven fabric, the nonwoven fabric by which many holes were carried out, and a porous membrane are mentioned.
Although the raw material of the water-permeable sheet 14 is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned.
The material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
Next, a description will be given of a configuration example in which a movable support unit that supports and deforms the tissue piece capturing unit is provided, and the tissue piece capturing unit is deformed through the operation of the support unit and switched from the contracted state to the expanded state.
FIG. 19 is a diagram illustrating a configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit. FIG. 19A is a front view, and FIG. 19B is a side view.
As illustrated in FIG. 19, the tissue piece capturing tool 10 f for aortic valve replacement surgery includes a ring-shaped support portion 15 and a capture sheet 16 attached to the support portion 15. Hereinafter, in FIG. 19, the lower side of the tissue piece capturing tool 10 f is referred to as “lower part”, and the upper side of the tissue piece capturing tool 10 f is referred to as “upper part”. As shown in FIG. 19, the tissue piece capturing device 10f of the present invention has a substantially disk shape, and has a shape that fits in the vicinity of the aortic valve annulus when the tissue sheet is captured by the capturing sheet 16, for example. is doing. Note that the shape of the tissue piece capturing tool 10f is not necessarily a substantially disk shape, and may be any shape that can block the aortic valve. For example, it may be substantially cylindrical.
At the time of introduction into the ventricle, the tissue piece capturing device 10f is contracted to such an extent that it can pass through the gap between the leaflets of the aortic valve. For example, as shown in FIG. 20, the support ring 15 is contracted left and right to bring the entire tissue piece capturing device 10f into a contracted state, and the tissue piece capturing device 10f is passed through the gap between the aortic valve leaflets in the contracted state. Introduce up to the valve annulus. Thereafter, the aortic valve can be closed by adjusting the direction in which the tissue piece is captured by the capture sheet 16 and then in the expanded state shown in the upper diagram of FIG.
The maximum diameter of the support portion 15 is not limited, but is preferably about 10 to 30 mm, for example, because it needs to fit in the aortic valve. Also, the height of the ring-shaped support portion 15 is not limited. However, since the ventricle is closed at the time of surgery and the tissue piece capturing device 10f cannot enter, if the height is too high, the tissue piece is located near the aortic valve. The capturing tool 10f is positioned, and the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of the valve leaflet. Therefore, for example, about 1 to 30 mm is preferable.
The structure of the support ring 15 is not limited, but a structure that can be transformed into a contracted state by a simple operation and can be returned to an expanded state by a simple operation, for example, by shape recovery by shape memory ability, is preferable. . As such a structure, for example, a ring structure and a spring structure having shape memory ability are preferable. Although the raw material of the support ring 15 is not limited, For example, stainless steel, titanium (Ti), tantalum (Ta), nitinol (Ni-Ti alloy), etc. are mentioned.
The structure of the capture sheet 16 is not limited, but a structure that can follow the deformation of the support ring 15 and can capture a tissue piece is preferable. As such a structure, a fiber, a nonwoven fabric, a porous structure, etc. are preferable, for example. The material of the capture sheet 16 is not limited, and examples thereof include silicon resin, fluorine resin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, and various blend materials.
FIG. 21 is a diagram illustrating another configuration example in which the tissue piece capturing unit 10 is deformed through the operation of the support unit 15. FIG. 21A is a front view, FIG. 21B is a side view, and FIG. 22 is a diagram schematically showing a contracted state.
As shown in FIG. 21, the tissue piece capturing tool 10 g includes a support balloon 17 and a capture sheet 16 attached to the support balloon 17. FIG. 21 shows a state in which air pressure is applied to the support balloon 17. As shown in FIG. 21, the tissue piece capturing tool 10g has a substantially disk shape in a state where air pressure is applied to the support balloon 17, and for example, when the tissue piece is captured by the capturing sheet 16, the aortic valve It has a shape that fits in the vicinity of the annulus. Note that the shape of the tissue piece capturing tool 10g is not necessarily a substantially disc shape when air pressure is applied, and may be any shape that can block the aortic valve inflow portion when air pressure is applied. For example, it may be substantially cylindrical.
When introduced into the ventricle, the tissue piece capturing device 10g is reduced to such an extent that it can pass through the gap between the aortic valve leaflets. For example, as shown in FIG. 22, when the air is extracted from the support balloon 17, the entire tissue piece capturing tool 10g is in a contracted state. The tissue piece capturing tool 10g is set in a contracted state, is passed through the gap of the aortic valve leaflet, and is introduced to the vicinity of the aortic valve annulus. The aortic valve can then be closed by adjusting the direction so that the tissue piece is captured by the capture sheet 16 and then returning the expanded state by applying air pressure to the support balloon 17.
Although the maximum diameter of the support balloon 17 in a state where air pressure is applied is not limited, it is preferable not to apply excessive pressure to the aortic valve, so that the support that closes the aortic valve in a state where it is in the vicinity of the aortic valve annulus is supported. The maximum diameter of the cross section of the balloon 17 is preferably about 10 to 30 mm, for example. Although the height is not limited, the ventricle is closed at the time of surgery, and the tissue piece capturing device 10g cannot enter. Therefore, if the height is too high, the tissue piece capturing device 10g is located in the vicinity of the aortic valve. Therefore, the working space is compressed and an obstacle occurs when performing a surgical operation such as excision of a leaflet. Therefore, for example, about 1 to 30 mm is preferable.
The material of the support balloon 17 may be a polymer material that can be stretched and is not limited. For example, polyethylene, polypropylene, polyester, polyurethane, polyamide, polyethylene terephthalate, polystyrene, polyvinyl alcohol, polyvinyl chloride, polyvinylidene chloride, Polymer materials such as polyimide, polyacetylene and polysulfone, and copolymers and mixtures thereof are applicable.
The structure of the capture sheet 16 is not limited, but a structure that can follow the deformation of the support balloon 17 and can capture a tissue piece is preferable. As such a structure, a fiber, a nonwoven fabric, a porous structure, etc. are preferable, for example. The material of the capture sheet 16 is not limited, and examples thereof include silicon resin, fluororesin, nylon resin, polyurethane resin, polyethylene resin, various elastomers, cellulose, chitosan, and various blend materials.
Next, an example of a brush-shaped three-dimensional tissue piece capturing tool 10h is shown. FIG. 23 and FIG. 24 are diagrams showing a configuration example of a brush-shaped three-dimensional tissue piece capturing tool 10h. FIG. 23 shows an expanded state of the tissue piece capturing tool 10h, and FIG. 24 shows a contracted state of the tissue piece capturing tool 10h. 23 and 24, (a) shows a side view and (b) shows a front view.
In this example, as shown in FIGS. 23 and 24, the tissue piece capturing tool 10 h sandwiches a large number of hair materials 191 along the longitudinal direction between the two core materials 18, and integrates these core materials 18 together. The hair material 191 is radially provided around the core material 18 by twisting. However, the tissue piece capturing tool 10h is not limited to such a configuration, and the hair material 191 is provided radially around the core material 18. Any configuration may be used as long as it is provided.
In this example, as shown in FIGS. 23 and 24, in the tissue piece capturing device 10h, the bristle material 191 is radially provided around the core material 18 in a direction perpendicular to the core material 18 in the expanded state, and the aortic valve annulus. It has a shape and size that fit in the vicinity and closes the aortic valve. For example, the outer diameter of the radial circle formed by the bristle material 191 around the core material 18 is 15 to 25 mm.
In this example, as shown in FIGS. 23 and 24, the contraction state of the tissue piece capturing tool 10h is reduced from the expanded state of FIG. 23 in the outer diameter of the radial circle formed by the bristle material 191 around the core material 18. It has a three-dimensional shape. For example, the outer diameter is 3 to 7 mm.
In this configuration example, as a deforming means, the contracted state is such that the disc-shaped bristle material 191 is closed like an umbrella, and the expanded state is such that the disc-like bristle material 191 is opened like an umbrella, so that the umbrella can be opened and closed. It is supposed to be deformed.
At the time of introduction into the ventricle, as shown in FIG. 24, the outer diameter of the radial circle formed by the bristle material 191 of the tissue piece capturing tool 10 h around the core material 18 can pass through the gap between the leaflets of the aortic valve. Shrink to the extent. The tissue piece capturing tool 10h is passed through the gap of the aortic valve leaflet in the contracted state and introduced to the vicinity of the aortic valve annulus. Thereafter, the aortic valve can be closed by the expanded state shown in FIG.
The material of the hair material 191 is not limited, but a material having elasticity is preferable so that the tissue piece capturing tool 10h can be switched naturally from the contracted state to the expanded state without requiring external force. In addition, a flexible material is preferable so as not to damage tissue such as a blood vessel wall. For example, polyamide, polyester, alkene polymer, diene polymer and the like can be mentioned.
Although the raw material of the core material 18 is not limited, the raw material which has the intensity | strength of the grade which can support the bristle material 191 is preferable. 23 and 24, when the tissue piece capturing tool 10h is configured to twist the core material 18 integrally, a material that is plastically deformed by applying an external force is preferable. For example, a metal, a synthetic resin monofilament, etc. are mentioned.
In addition, as a configuration of the tissue piece capturing tool 10h, a configuration in which a hair material that becomes the support portion 15 is combined with a cloth material that becomes the capture portion 16 to increase the ability to capture tissue piece residue is possible.
A tissue piece capturing tool 10h ′, which is a first configuration by combining cloth materials, is shown. In this example, the support portion 15 is at least one disc-like brush provided with a hair material radially from the center toward the outer periphery, and the capturing portion 16 is a cloth material covering the periphery of the brush. is there.
As shown in FIGS. 25 and 26, the tissue piece capturing tool 10 h ′ has a configuration in which the periphery of the hair material 191 provided radially around the core material 18 is further covered with a cloth material 192. With such a configuration, the aortic valve can be closed more densely, so that more tissue fragment residue generated when the aortic valve is excised can be captured. FIG. 25 shows an expanded state of the tissue piece capturing tool 10h ′, and FIG. 26 shows a contracted state of the tissue piece capturing tool 10h ′. 25 and 26, (a) shows a side view and (b) shows a front view.
Although the structure of the cloth material 192 is not limited, it is more preferable in performing the operation that the tissue piece capturing tool 10h ′ closes the aortic valve to the extent that the liquid such as blood is not completely blocked. Is preferred. For example, a nonwoven fabric, a nonwoven fabric with many holes, and a porous membrane are mentioned.
Although the raw material of the fabric material 192 which has water permeability is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned.
The material of the hydrophobic fiber is not limited, and examples thereof include polyester, polypropylene, and polyethylene terephthalate.
Next, a tissue piece capturing tool 10h ″ which is a second configuration by combining cloth materials is shown. In this example, a plurality of disc-shaped support members 15 are provided with hair materials radially from the center toward the outer periphery. It is a structural example which is a brush and the capture part 16 is a disk-shaped cloth material inserted between the brushes.
As shown in FIGS. 27 and 28, the tissue piece capturing tool 10 h ″ has a configuration in which a cloth material 192 is sandwiched between brush-shaped three-dimensional hair materials 191 disposed along the longitudinal direction of the core material 18. Fig. 27 is a diagram showing the expanded tissue piece capturing tool 10h ", and Fig. 28 is a schematic exploded view of two bristle materials 191 and a cloth material 192 sandwiched between them. It is a figure.
The material of the core material 18 is made of, for example, a general resin (ABS, PP, PE, PC, acrylic, PET), and in this configuration example, has a cylindrical shape.
The material of the bristle material 191 may also be made of a general resin, and is a ring shape in which resin hairs are planted in a circle. For example, the diameter of the ring is about 2 to 3 cm in diameter, and the thickness of the hair is 0.1 mm or less. The bristle material 191 may have any configuration as long as the bridging material 191 is provided radially around the core material 18.
The material of the cloth material 192 is a fibrous material such as a non-woven fabric or gauze, and is preferably a fiber material that has water permeability and is not easily bent or twisted. Although the raw material of the fabric material 192 which has water permeability is not limited, For example, what carried out the hydrophilic process of the hydrophobic fiber is mentioned. Examples thereof include polyester, polypropylene, and polyethylene terephthalate.
In the configuration example of the tissue piece capturing tool 10h ″ shown in FIGS. 27 and 28, a non-woven cloth material 192 having substantially the same diameter is sandwiched between two circular brush-like bristle materials 191. Adhesion between the bristle material 191 and the cloth material 192 is not performed, etc. The structure is such that the cloth material 192 is inserted between the bristle material 191 as a so-called filter. The cloth material 192 may have a diameter slightly larger than the diameter of the bristle material 191 in order to improve the adhesion between the blood vessel wall. Moreover, although the bristle material 191 and the cloth material 192 may be bonded, it is necessary to consider so as not to disturb the blood flow.
A size of about 3 cm in the longitudinal direction is easy to use at the time of surgery, but in order to improve the operability at the time of insertion, a removable extension rod may be attached. Moreover, it is also preferable to make it easy to take out by making a hole at the end and passing the thread.
As described above, according to the tissue piece capturing tool for aortic valve replacement surgery according to the present invention, it is possible to start capturing the tissue fragment residue from the time of starting resection of the valve leaflet by attaching it to the surgical affected area. Compared to the capture tool, the tissue fragment residue can be captured more reliably and without leakage.

As a tissue piece capturing tool for aortic valve replacement surgery according to the second embodiment, a configuration example including a collection tool 30 joined to the tissue piece capturing tool 10 will be described. The tissue piece capturing device of the present invention according to Example 2 is
In addition to the tissue piece capturing tool 10 shown in the first embodiment, a thread-like, tubular or rod-like collecting tool 30 is provided, and one end of the collecting tool 30 is left on the aorta side before and after the aortic valve replacement operation. The tissue piece capturing tool 10 can be recovered from the aorta side by pulling one end of the recovery tool 30 after the replacement operation.
FIG. 29 is a diagram illustrating a configuration in which a recovery tool 30 is provided to the tissue piece capturing tool 10a having a substantially cylindrical solid shape illustrated in FIG. FIG. 29 shows a perspective view.
As shown in FIG. 29, the recovery tool 30 is attached to the upper part of the tissue piece capturing tool 10a. However, the attachment position is not limited to the upper part, and the recovery tool 30 is pulled in the blood flow direction after aortic valve replacement surgery. If the tissue piece capturing tool 10a can be recovered outside the body through the aortic valve gap, the recovery tool 30 may be joined to any position of the tissue piece capturing tool 10a.
FIG. 30 is another configuration example of the tissue piece capturing device for aortic valve replacement surgery according to the second embodiment of the present invention, and the tissue piece capturing device 10f with the support ring 15 shown in FIG. 19 of the first embodiment. It is a figure which shows the structure provided with the collection | recovery tool 30 with respect to. FIG. 30 shows a perspective view.
As shown in FIG. 30, the recovery tool 30 is attached to the support ring 15 of the tissue piece capturing tool 10f, but the attachment position is not limited, and the recovery tool 30 is pulled in the direction of blood flow after aortic valve replacement surgery. As long as the tissue piece capturing device 10f can be recovered from the aortic valve gap to the outside of the body, any position of the support ring 15 may be used. In the example of FIG. 30, the recovery tool 30 is extended from the joint point with the support ring 15 to the vicinity of the center of the capture sheet 16 and further extended in a linear direction perpendicular to the capture sheet 16. This is a device for positioning the end of the collection tool 30 located on the opposite side of the joint point with the support ring 15 in the vicinity of the center of the capture sheet 16 when viewed in a linear direction perpendicular to the capture sheet 16. .
When attempting to recover the tissue piece capturing device 10f from the aortic valve gap to the outside of the body by pulling the recovery device 30 in the direction of blood flow after the aortic valve replacement surgery, the end of the recovery device 30 is grasped with a finger or the like. Since the end portion is pulled in the direction of blood flow, positioning the end portion in this way makes it difficult for the end portion to approach the wall portion in the body and facilitates an operation of grasping with a finger or the like. However, it is not essential for the collection tool 30 to take such a configuration. For example, the collection tool 30 may be stretched as it is in a linear direction perpendicular to the capture sheet 16 from the joint point with the support ring 15.
Although the structure of the collection | recovery tool 30 is not limited, For example, thread shape, tubular shape, or rod shape etc. are mentioned.
Further, the length of the recovery tool 30 is not limited, and may be a length that allows the tissue piece capturing tool 10f to be recovered from the aortic valve gap outside the body by pulling the recovery tool 30 in the blood flow direction after the aortic valve replacement operation. That's fine. Therefore, for example, about 20 to 200 mm is preferable.

The structural example with the introduction tool 40 and the opening tool 50 is shown as a tissue piece capture tool set for aortic valve replacement operation concerning Example 3. FIG.
The introducer 40 is a tubular member having an outer diameter that can pass through the gap between the aortic valve leaflets.
The release tool 50 is a jig that pushes out the tissue piece capturing tool 10 housed inside the tubular member introduction tool 40 and releases it from the introduction tool.
The tissue piece capturing device 10 is in a contracted state and has a shape and size that can pass through the inside of the introduction device 40. Prior to the replacement operation of the aortic valve, the introduction device 40 that houses the tissue piece capturing device is inserted into the aortic valve leaflet. By introducing it into the gap, a passage from the aorta side to the left ventricle side is ensured, the tissue piece capturing device 10 is pushed out by the opening device 50, and after the tissue piece capturing device 10 is introduced into the left ventricle, the expanded state is obtained. The aortic valve is closed in the vicinity of the annulus and the entry of the tissue fragment residue into the left ventricle is suppressed.
31 and 32 are diagrams showing a configuration example of a tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissue piece capturing tool 10. In addition, as an attachment position of the collection | recovery tool 30, it is the example attached to the support ring 15. FIG. 31 and 32 show perspective views.
FIG. 31 shows a state in which the tissue piece capturing tool 10f is accommodated in the introduction tool 40. On the other hand, FIG. 32 shows a state in which the tissue piece capturing tool 10f is released by pushing it out from the inside of the introduction tool 40 through the release side opening 41. In this example, since the collection tool 30 is attached to the support ring 15 as a mounting position, the tissue piece capturing tool 10f is deployed as shown in FIG. Is done.
FIGS. 33 and 34 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10f shown in Example 1 was used as an example of the tissue piece capturing tool 10. Note that, as shown in FIG. 30 of the second embodiment, the collection tool 30 is attached at the end portion of the collection sheet 30 near the center of the capture sheet 16. 33 and 34 show perspective views.
FIG. 33 shows a state in which the tissue piece capturing tool 10f is housed in the introduction tool 40. On the other hand, FIG. 34 shows a state in which the tissue piece capturing tool 10f is released by being pushed out from the inside of the introduction tool 40 through the release side opening 41. In this example, since the collection tool 30 is attached near the center of the capture sheet 16, the tissue piece capture tool 10f is pushed out from the inside of the introduction tool 40. As a result, the tissue piece capture is shown in FIG. The tool 10f is deployed.
FIGS. 35 and 36 are diagrams showing another configuration example of the tissue piece capturing tool set for aortic valve replacement surgery according to Example 3 of the present invention. In this configuration example, the tissue piece capturing tool 10g deformed by the support balloon 17 shown in the first embodiment is used as an example of the tissue piece capturing tool 10. 35 and 36 show perspective views. FIG. 35 shows a state in which the tissue piece capturing tool 10g is housed in the introduction tool 40. FIG. On the other hand, FIG. 36 shows a state in which the tissue piece capturing tool 10g is released by being pushed out from the inside of the introducing tool 40 through the release side opening 41.
As shown in FIGS. 31 to 36, the introduction tool 40 is substantially tubular and includes a release side opening 41 at one end in the long axis direction. In the example of FIGS. 31 to 36, the introduction tool 40 includes an accommodation-side opening 42 at the other end. This is a device that enables the tissue piece capturing tool 10 to be accommodated in the introduction tool 40 through an opening different from the opening 41 on the release side. In addition, it is not limited so that the introduction tool 40 may be provided with such an accommodation side opening 42.
When introducing into the ventricle, the tissue piece capturing device 10 is first housed in the introduction device 40 through the storage side opening 42 or the release side opening 41 in the contracted state, and the tissue piece capturing device 10 is stored. In this state, the introducer 40 is passed through the gap of the aortic valve leaflet, and the release side opening 41 is introduced to the vicinity of the aortic valve annulus. Thereafter, the tissue piece capturing tool 10g is released to the outside from the release side opening 41, and the aortic valve can be closed by adjusting the direction so that the tissue piece is captured by the capturing sheet 16.
The diameter of the diameter of the cylindrical cross section of the introducer 40 is not limited, but is preferably about 3 to 10 mm, for example, because it is necessary to pass through the gap of the aortic valve leaflet. The length in the major axis direction of the introduction tool 40 is not limited as long as it is a length that can accommodate the tissue piece capturing tool 10g. However, if the length in the major axis direction of the introducer 40 is too long, the accommodation side opening 42 is likely to come into contact with the inner wall of the ascending aorta when the release side opening 41 is positioned in the aortic valve inflow part, Since positioning of the introducer 40 may be difficult, it is preferably about 20 to 100 mm if possible.
Although the raw material of the introduction tool 40 is not limited, For example, various polymers, such as a polypropylene, an acrylonitrile butadiene styrene copolymer (ABS), polymethylpentene, etc. are mentioned.
As an example of the release tool 50, there is a push bar for pushing out and releasing the tissue piece capturing tool 10 accommodated in the introduction tool 40 from the release side opening 41.
FIG. 37 is a view showing a state in which the tissue piece capturing tool 10 is pushed out by the push-out rod 50 as the opening tool 50. By inserting the push rod 50 into the introduction tool 40, the tissue piece capturing tool 10 housed therein is pushed out, and the tissue piece capturing tool 10 is opened to the outside from the release side opening 41. . If the release side opening 41 is positioned near the aortic valve annulus in the ventricle, the tissue piece capturing tool 10 is opened near the aortic valve annulus.

Next, a procedure for placing the tissue piece capturing tool 10 for aortic valve replacement surgery according to the present invention will be described in detail.
The indwelling procedure of the tissue piece capturing tool for aortic valve replacement surgery according to the present invention will be described in detail step by step with reference to the drawings.
FIGS. 38 to 41 are views for explaining the placement procedure of the tissue piece capturing tool 10 for aortic valve replacement surgery in the vicinity of the aortic valve annulus according to the present invention. In the example of this procedure, it is a structural example with the collection | recovery tool 30, and is an example using the introduction tool 40 in the case of introduction | transduction.
It should be understood that various configuration examples of the first to third embodiments can be applied to the indwelling procedure of the tissue piece capturing tool 10 for aortic valve replacement surgery. Also, for ease of explanation, the various elements shown in the figures are not drawn to scale.
(Procedure 1)
An incision is made in the ascending aorta wall near the leaflet of the aortic valve 3 (see FIG. 38). This procedure ensures a path for the operator's hand and capture tool set to access the aortic valve from outside the ascending aorta.
(Procedure 2)
The tissue piece capturing device 10 is first introduced into the ascending aorta 2 in the heart 1 by being introduced through the incision in a state of being accommodated in the introduction device 40 as a contracted state. The valve is passed through the leaflet gap 4 and introduced to the vicinity 6 of the annulus of the aortic valve 3 (see FIG. 39).
A notch may be provided in advance in the leaflet of the aortic valve 3, and this notch may be used as an introduction path for the tissue piece capturing tool 10. The length of the cut is not limited, but a cut having a maximum length of about 10 mm or less is preferable because there is no risk of a tissue piece being formed when the cut is made, and the tissue piece does not enter the ventricle.
(Procedure 3)
After passing through the aortic valve leaflet, the aortic valve 3 is closed by placing the tissue piece capturing device 10 in an expanded state and is placed in the vicinity of the aortic valve annulus (see FIG. 40).
(Procedure 4)
The introducer 40 is taken out from the incision to the outside of the ascending aorta (see FIG. 41).
(Procedure 5)
After completion of the aortic valve replacement surgery, the tissue collection device 10 is taken out of the ascending aorta and collected by pulling the collection device 30.
As described above, the configuration example and the preferred embodiment of the method for using the tissue piece capturing device for aortic valve replacement surgery according to the present invention have been illustrated and described, but various modifications can be made without departing from the technical scope of the present invention. It will be understood that.

The tissue piece capturing device for aortic valve replacement surgery according to the present invention can be applied to a patient requiring aortic valve replacement surgery as an instrument for assisting the surgery.
While preferred embodiments of the invention have been illustrated and described, it will be appreciated that various changes can be made without departing from the scope of the invention. Therefore, the technical scope of the present invention is limited only by the description of the appended claims.

Claims

A tissue fragment capturing device for aortic valve replacement surgery that suppresses the invasion of tissue fragment residue that may occur with resection of the aortic valve in the replacement of the aortic valve of the heart into the left ventricle,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; It has an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the aorta is passed through the gap of the aortic valve leaflet from the aorta side to the left ventricle side in the contracted state, and is in the expanded state after the introduction of the left ventricle. A tissue fragment capturing tool for aortic valve replacement surgery, which closes the aortic valve in the vicinity of an annulus and prevents the tissue fragment residue from entering the left ventricle.
The tissue piece capturing tool for aortic valve replacement surgery according to claim 1, wherein the contracted state is switched to the expanded state by applying air pressure.
The tissue fragment capturing tool for aortic valve replacement surgery according to claim 1, wherein the contracted state is changed to the expanded state by absorbing liquid.
The aortic valve replacement surgery according to claim 3, wherein the whole is made of an inflatable material that expands by absorbing liquid, and the liquid is absorbed to change from the contracted state to the expanded state. Tissue piece trap.
An inflatable material that expands by absorbing liquid; and a sheet-like capturing portion that wraps the expandable material, and the inflatable material absorbs liquid to change the expanded state from the contracted state to the expanded state. The tissue piece capturing tool for aortic valve replacement surgery according to claim 3, wherein
A sheet-like capture unit that captures the tissue piece, and a movable support unit that supports and deforms the capture unit,
2. The tissue piece capturing tool for aortic valve replacement surgery according to claim 1, wherein the capturing section is changed from the contracted state to the expanded state by deforming the capturing section through operation of the support section.
The said support part is at least 1 disk-shaped brush which provided the hair material radially toward the outer periphery from the center, The said capture | acquisition part is the cloth material which covered the circumference | surroundings of the said brush. A tissue piece capture device for aortic valve replacement surgery.
The support part is a plurality of disk-shaped brushes provided with hairs radially from the center toward the outer periphery, and the capturing part is a disk-shaped cloth material interposed between the brushes. 6. A tissue piece capturing tool for aortic valve replacement surgery according to 6.
The deformation of the capturing part by the operation of the support part is such that the contraction state of the brush of the support part is a state in which the disk-shaped brush is closed in an umbrella shape, and the expanded state is the umbrella in which the disk-shaped brush is an umbrella. The tissue piece capturing tool for aortic valve replacement surgery according to any one of claims 6 to 8, wherein the tissue piece capturing tool is in an open state.
A thread-like, tubular or rod-like recovery tool connected to the support part,
Leave one end of the recovery tool on the aorta side before and after the aortic valve replacement surgery,
The aortic valve replacement operation according to any one of claims 1 to 9, wherein the aortic valve is allowed to pass through by pulling one end of the recovery tool after the aortic valve replacement operation, thereby enabling recovery from the aortic side. Tissue piece capture tool.
A tissue fragment capturing device set for aortic valve replacement surgery that suppresses invasion of tissue fragment residue that may occur with resection of the aortic valve in the replacement of the aortic valve of the heart into the left ventricle,
A tubular member introducer having an outer diameter passing through the gap of the aortic valve leaflet;
A tissue piece capturing device comprising a contracted state having a shape and size capable of passing through the inside of the introducer, and an expanded state having a shape and size that fits in the vicinity of the aortic valve annulus in the left ventricle and closes the aortic valve When,
An opening tool that pushes out the tissue piece capturing tool housed inside the introduction tool and releases it from the tubular member;
Prior to the replacement operation of the aortic valve, the introducer that houses the tissue piece capturing device in the contracted state is introduced into the gap of the aortic valve leaflet so that the left ventricle side from the aorta side. The aorta is secured by allowing the tissue piece capturing device to be pushed out by the opening device and passing through the inside of the introducing device, and after the tissue piece capturing device is introduced into the left ventricle, the expanded state is established. A tissue piece capturing tool set for aortic valve replacement surgery, which closes the aortic valve in the vicinity of the annulus and prevents the tissue piece residue from entering the left ventricle.
A method for capturing a tissue fragment in an aortic valve replacement operation that suppresses invasion of a tissue fragment residue into the left ventricle, which may be caused by excision of the aortic valve in the replacement operation of the aortic valve of the heart,
A contracted state that is shaped and sized to pass through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side, and a shape that closes the aortic valve annulus in the left ventricle and closes the aortic valve; Using a tissue piece capture device with an expanded state that becomes a size,
Prior to the replacement operation of the aortic valve, the tissue piece capturing device is passed through the gap of the aortic valve leaflet from the aorta side toward the left ventricle side in the contracted state, and the expanded state after the introduction of the left ventricle Thus, the aortic valve is closed in the vicinity of the aortic annulus and the tissue fragment residue is prevented from invading into the left ventricle.