JP2008161346A - Medical instrument and its manufacturing method - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a medical instrument and its manufacturing method having a configuration perfectly fitting to a part to be applied where there are differences among patients. <P>SOLUTION: A net 1 for correcting a cardiac configuration is a medical instrument which stores a part of the heart 3 inside and encircles the stored part from outside to regulate excessive expansion of the heart 3. The net 1 for correcting the cardiac configuration is knitted by a knitting machine knitting yarns into a three-dimensional shape on the basis of knitting data showing the three-dimensional shape and, as the knitting data based on three-dimensional data given to the knitting machine, knitting data based on three-dimensional data obtained by photographing a three-dimensional shape of the heart 3 by an MRI (or CT) every patient are used. Thus, the shape of the net 1 for correcting the cardiac configuration is a shape fitting to the three-dimensional shape of the heart 3 and, even when there are differences in size and shape of the heart among the patients, the shape perfectly fits to each patient. <P>COPYRIGHT: (C)2008,JPO&INPIT

Description

  The present invention relates to a medical device having a form that closely matches an application target site having individual differences for each patient, and a manufacturing method thereof.

2. Description of the Related Art Conventionally, as one of medical devices for treating heart disease, a heart shape correction net that is attached to the outside of the heart has been proposed (see Patent Document 1).
The above-mentioned medical device is a mesh-shaped cloth formed in a cup shape, and is intended to prevent further deterioration of the heart failure by attaching it to the outside of the heart of an enlarged heart failure patient to prevent further heart expansion. is there.
Special table 2003-532489 gazette

  However, the medical instrument described in Patent Document 1 requires excision and suturing of unnecessary portions in accordance with the size of the patient's heart during the operation. There is only a rough index such as the degree of sewage of less than 10%, and the degree of sewage depends on the judgment of the surgeon during the operation. For this reason, the optimum adjustment is not always made, and therefore, the results may vary. In addition, there is a problem in that, since it is necessary to reverse the heart, the patient is burdened heavily, and the operation cost for the heart-lung machine is increased.

In the above description, the treatment for the heart has been described. However, the same kind of problem may occur in the treatment for other than the heart.
For example, in an aortic root artificial blood vessel replacement, an operation is performed to replace a complex shaped aortic base with three bulges called Valsalva sinus and an aortic valve inside it with an artificial blood vessel. Since it is difficult to prepare an artificial blood vessel having such a complicated shape, there is a problem that only a simpler artificial blood vessel can be used.

  The present invention has been made to solve the above-described problems, and an object of the present invention is to provide a medical device having a form that closely matches an application target site having individual differences for each patient, and a manufacturing method thereof. There is to do.

The characteristic configuration employed in the present invention will be described below.
The medical device of the present invention was obtained by measuring the three-dimensional shape of the application target part for each patient with respect to a knitting machine capable of knitting a knitting yarn into a three-dimensional shape based on knitting data representing a three-dimensional shape. The knitted fabric is knitted by giving the knitting data based on three-dimensional data.

  This medical device is knitted by a knitting machine capable of knitting a knitting yarn into a three-dimensional shape based on knitting data representing a three-dimensional shape. As an example of such a knitting machine, for example, a computerized flat knitting machine (product name: SWG041, manufactured by Shima Seiki Co., Ltd.) compatible with WHOLEGARMENT (registered trademark) can be cited. If such a knitting machine is used, a knitting fabric having a three-dimensional shape represented by the knitting data is obtained by giving knitting data representing a three-dimensional shape from the knitting machine control workstation to the knitting machine. Is organized in

  The knitting yarn is made of a biocompatible material, and its material and thickness are not particularly limited as long as it has a performance suitable for the purpose of use of the medical device. For example, polyester, polytetra Examples thereof include those obtained by twisting single fibers such as fluoroethylene, expanded polytetrafluoroethylene (expanded PTFE, ePTFE), polypropylene, and polydifluoroethylene (hexafluoropropylene-vinylidene fluoride). Only one type of knitting yarn made of these materials may be used, or two or more types may be used.

  The knitting data given to the knitting machine is data based on three-dimensional data obtained by measuring the three-dimensional shape of the application target part for each patient. Such three-dimensional data is obtained by, for example, tomography such as multi-detector CT (MD-CT), nuclear magnetic resonance imaging (MRI), and cardiac ultrasound imaging. Using an apparatus (medical image diagnostic apparatus), tomographic images of the application target part are taken at a plurality of locations, and the outline (two-dimensional data) of the application target part is extracted from each tomographic image. Can be created based on.

  To give a more specific example, in the case of the computer flat knitting machine (product name: SWG041) exemplified above, the surface of the three-dimensional shape is divided into several regions in advance, and the shape of each region is determined. Create three-dimensional shape by creating data to show and how to sew together between these multiple areas (where and where) to create a three-dimensional data and give the data to a computer flat knitting machine Can be knitted without sewing.

  Therefore, the contour (two-dimensional data) of the application target part extracted from the tomographic image is divided into several regions in advance, and the data representing the shape of each region and how the multiple regions are If the data indicating the three-dimensional shape by stitching is created, then the data is given to the computer flat knitting machine as the knitting data, so that the three-dimensional shape of the application target portion can be obtained. Fit knitting can be knitted.

  That is, the medical instrument of the present invention is a first step of taking a plurality of tomographic images by a tomography apparatus, and a first step of extracting the contour of the application target site in each tomographic image obtained in the first step. The third step of creating three-dimensional data representing the three-dimensional shape of the application target portion based on the contour extracted in the second step, the second step, and the knitting data representing the three-dimensional shape By giving the knitting data based on the three-dimensional data created in the third step to the knitting machine capable of knitting the knitting yarn into a three-dimensional shape based on the shape, it has a shape that matches the application target part And a fourth step of knitting a knitted fabric.

  According to the medical device configured as described above, since the knitted fabric is in a form that matches the three-dimensional shape of the application target part, even if there are individual differences in the size and shape of the application target part for each patient, The medical device has a form that fits perfectly with each patient.

  To give a more specific example, for example, the medical device of the present invention accommodates a part of the heart inside, and surrounds the accommodated part from the outside, thereby restricting excessive expansion of the heart. A medical instrument used as a morphological correction net, wherein the knitted fabric is further adapted to three-dimensional data obtained by photographing the three-dimensional shape of the heart with a tomography apparatus for each patient, according to a case for each patient. It is preferable that the knitting data including the correction value obtained in this way is knitted by giving it to the knitting machine.

  According to the medical device configured in this manner, the knitted fabric conforms to the three-dimensional shape of the heart, so even if there are individual differences in the size and shape of the heart for each patient, it is perfect for each patient. A heart shape correction net having a suitable shape is formed, and when it is worn, it is only necessary to cover the heart shape correction net over the heart. Therefore, unlike general-purpose heart shape correction nets that are made larger, there is no need to remove unnecessary parts according to the size of the patient's heart during the operation, so that the operation can be performed as quickly as possible. Since the time can be greatly shortened, the burden on the patient can be reduced.

  In addition, even if the surgeon does not determine the degree of stitching during the operation, the heart shape correction net can be knitted after setting the optimum shape in advance, and thus variation in results can be suppressed. In addition, it is possible to fit the heart exactly without having to reverse the heart and wear it. This also reduces the burden on the patient and also reduces the operating cost of the heart-lung machine etc. Can do.

  In addition to preventing dilation of the heart, it is possible to cope with mitral regurgitation that is complicated. In other words, in the case of a large-sized general-purpose heart shape correction net, it is necessary to repair mitral regurgitation from the inner surface of the heart under separate cardiopulmonary arrest, which greatly increases the patient's invasive and medical costs. However, in the case of the present invention, the shape of the heart shape correction net can be designed on a computer to optimize the amount of mitral valve annulus stitches and correct the papillary muscle position. That is, by adding correction values obtained according to cases for each patient in advance on the computer, not only the prevention of dilation of the heart but also treatment for other complications can be realized.

  Alternatively, the medical instrument of the present invention may be a medical instrument that is used as an artificial blood vessel that replaces a part of a blood vessel. In this case, the knitted fabric forms a three-dimensional shape of the blood vessel by a tomography apparatus for each patient. The knitting data based on the three-dimensional data obtained by photographing may be knitted by giving the knitting machine.

  When configured as an artificial blood vessel, a knitted fabric in which the gaps between the knitted yarns are clogged with blood is knitted by knitting relatively thin knitting yarns at high density. In order to prevent blood from leaking between the yarns during the operation, a structure in which collagen or gelatin is filled in the gaps of the yarns in advance may be employed.

  According to the medical device configured in this way, the knitted fabric has a form that matches the three-dimensional shape of the blood vessel. Therefore, unlike a simple tubular artificial blood vessel, the blood vessel has complicated unevenness and has a complicated shape. An artificial blood vessel having a shape equivalent to a curved blood vessel can be constructed, and a blood vessel having a lesion can be replaced with an artificial blood vessel in a more natural manner.

  For example, an artificial blood vessel having a shape equivalent to a complex aortic base having three bulges called Valsalva sinus and having an aortic valve inside thereof can be constructed. The blood vessel can be used in aortic proximal vascular replacement.

  Alternatively, an artificial blood vessel having an equivalent shape can be formed even in a arch aorta, an abdominal aorta, or the like having a branching or bending point. Therefore, such an artificial blood vessel is replaced with an arch aorta or abdominal aorta artificial blood vessel replacement. Can be used.

Next, an embodiment of the present invention will be described with an example.
FIG. 1A is a perspective view of a heart shape correction net corresponding to an example of the medical instrument of the present invention, and FIG. 1B is a perspective view showing a state where the heart shape correction net is attached to the heart.

  The heart shape correction net 1 is formed by knitting yarns such as polyester, polytetrafluoroethylene, foamed polytetrafluoroethylene (foamed PTFE, ePTFE), polypropylene, polydifluoroethylene (hexafluoropropylene-vinylidene fluoride), and the like. As shown in FIG. 1 (b), a medical instrument that regulates excessive expansion of the heart 3 by housing a part of the heart 3 inside and surrounding the housed part from the outside. is there.

  This heart shape correction net 1 is knitted by a knitting machine capable of knitting a knitting yarn into a three-dimensional shape based on knitting data representing a three-dimensional shape. As knitting data given to this knitting machine, the heart The knitting data created based on the data obtained by photographing the three-dimensional shape of each patient by MRI for each patient is used. Therefore, the form of the heart shape correction net 1 is a form that matches the three-dimensional shape of the heart 3, and is a form that fits perfectly to each patient even if there are individual differences in the size and shape of the heart for each patient. It has become.

  In FIG. 1A and FIG. 1B, a knitted fabric having a square stitch is drawn as the knitted fabric of the heart morphological correction net 1, but this is for convenience to simplify the illustration. It is only a measure, and the actual knitted fabric is either a knitted sheet or a mesh.

Next, equipment for manufacturing the heart morphological correction net 1 will be described.
As shown in FIG. 2, the manufacturing equipment for the heart morphological correction net 1 includes a nuclear magnetic resonance diagnostic apparatus 11 (or a multi-row detector CT diagnostic apparatus 11 ′), an image processing workstation 12, a cardiac ultrasonic examination apparatus. 14, a CAD workstation 20, a CAD workstation 21 for a knitting machine, a computer-controlled flat knitting machine 22, and the like.

  Among these facilities, the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector CT diagnostic apparatus 11 ′), the image processing workstation 12, and the cardiac ultrasonic examination apparatus 14 are ordered from the heart shape correction net 1. This equipment is installed at the main hospital. The CAD workstation 20, the knitting machine CAD workstation 21, and the computer-controlled flat knitting machine 22 are facilities installed in a manufacturer (manufacturing factory) that manufactures the heart shape correction net 1.

  As is well known, the nuclear magnetic resonance diagnostic apparatus 11 is an apparatus for taking a tomographic image of a human body using nuclear magnetic resonance. The multi-row detector CT diagnostic apparatus 11 'is an apparatus for taking a tomographic image of a human body using X-rays as is well known. Either of these nuclear magnetic resonance diagnostic apparatus 11 and multi-row detector type CT diagnostic apparatus 11 'may be used.

  The image processing workstation 12 performs data processing on tomographic image data (MRI imaging data or CT contrast data) captured by the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector CT diagnostic apparatus 11 ′). In the present embodiment, the image processing workstation 12 extracts cardiac tomographic image data (cardiac MRI image data or cardiac CT image) at the end diastole and end systole.

  The cardiac ultrasound examination apparatus 14 is an apparatus for examining the form of the heart based on the reflection of the ultrasound, and is used in combination with the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector type CT diagnostic apparatus 11 ′). It is used to more accurately grasp the heart shape. Further, by accurately diagnosing individual pathological conditions of patients with mitral regurgitation using the cardiac ultrasonography device 14, the suitability of treatment by the cardiac morphological correction network 1 and the cardiac morphological correction network 1 It is possible to set the amount of mitral valve stitching and the setting of the amount of shortened heart diameter at the papillary muscle level.

  The CAD workstation 20 is a device for performing data processing based on data sent from the image processing workstation 12 and the cardiac ultrasound examination apparatus 14, and as data processing software, for example, three-dimensional image construction software (for example, Product name: ZedView (registered trademark), manufactured by Lexi Co., Ltd.), general-purpose CAD software (for example, product name: VectorWorks (registered trademark), manufactured by Nemecheck North America, Inc.), and the like.

  In the present embodiment, processing for extracting the boundary line from the threshold value of the two-dimensional tomographic data (DICOM data) acquired from the image processing workstation 12 and constructing the three-dimensional data using the three-dimensional image construction software. Executed. When the three-dimensional data is completed, the data format of the three-dimensional data conforms to the specification of the computer-controlled flat knitting machine 22 from a binary data format DXF (Data eXchange Format) file by using the general-purpose CAD software. It is converted to a DXF file (pattern data to be described later) in a text data format.

  The CAD workstation 20 also sets a correction value such as adjusting the amount of heart stitches based on the cardiac ultrasound data acquired from the cardiac ultrasound examination apparatus 14. The data necessary for setting the correction values include left ventricular end diastolic diameter (LVDd), left ventricular end systolic diameter (LVDs), left ventricular long axis diameter, mitral valve annulus diameter (short diameter, long diameter), and papillary muscle attachment position. The amount of displacement of the systolic mitral valve joint position (called tethering or tenting, the vertical distance between the mitral valve annulus and the mitral valve leaflet junction), mitral valve reverse flow ( And a backflow site (evaluated with a short axis). By setting correction values based on these various data, the above-described three-dimensional data is corrected to data that is considered optimal for each individual case.

  Since the shape of the outer periphery of the heart is more accurate when calculated from the MD-CT image, it is measured based on the MD-CT image without correction based on the cardiac ultrasound examination data. That is, optimal data is constructed by taking advantage of the respective advantages of the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector CT diagnostic apparatus 11 ') and the cardiac ultrasound examination apparatus 14. Whether or not to make corrections based on cardiac ultrasonography data, and how much correction would be optimal, will be examined by, for example, the joint work of cardiac surgeons and image processing personnel at the manufacturer, If necessary, it will be discussed with the orderer (cardiac surgeon at the main hospital), and the data considered to be optimal for each individual case will be completed.

  The knitting machine CAD workstation 21 is a device for controlling the computer-controlled weft knitting machine 22 based on the three-dimensional data (DXF file in text data format) transmitted from the CAD workstation 20.

  The computer-controlled flat knitting machine 22 is an apparatus for knitting a knitting yarn into a knitted fabric having a three-dimensional shape based on a command from the CAD workstation 21 for knitting machines. In the present embodiment, WHOLEGARMENT (registered trademark) is used. A compatible computer flat knitting machine (product name: SWG041, manufactured by Shima Seiki Seisakusho Co., Ltd.) is used.

  Among the facilities as described above, the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector type CT diagnostic apparatus 11 ′), the image processing workstation 12, and the cardiac ultrasonic examination apparatus 14 are the cardiac surgeon at the basic hospital side. It is operated by a cardiologist or radiologist, and two-dimensional tomographic data (DICOM data) and cardiac ultrasonography data of the heart are prepared at the basic hospital side. Then, these two-dimensional tomographic data and cardiac ultrasound examination data are transmitted to a manufacturer (manufacturing factory) via a communication line.

  On the manufacturer (manufacturing factory) side, various data transmitted from the basic hospital side are received, and data processing at the CAD workstation 20 as described above is performed. When the knitting data based on the three-dimensional data is completed on the CAD workstation 20, the knitting data is transmitted to the CAD workstation 21 for the knitting machine.

  The CAD workstation 21 for knitting machines and the computer-controlled flat knitting machine 22 are operated by a person in charge on the manufacturer side, and knit the knitting yarn based on the knitting data, thereby having a form represented by the knitting data. Net 1 is manufactured. The manufactured heart morphological correction net 1 is immediately delivered to a basic hospital as an ordering source for use.

Next, the manufacturing procedure of the heart shape correction net 1 will be described in more detail.
When the heart morphological correction net 1 is manufactured, first, cardiac MRI (or cardiac CT) is imaged by the nuclear magnetic resonance diagnostic apparatus 11 (or multi-row detector CT diagnostic apparatus 11 ′) (S10). . The nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector CT diagnostic apparatus 11 ′) automatically performs tomographic imaging based on imaging conditions set in advance.

  When the tomographic imaging is completed, data transfer from the nuclear magnetic resonance diagnostic apparatus 11 (or multi-row detector CT diagnostic apparatus 11 ′) to the image processing workstation 12 is performed (S20), and the image processing work is performed. In the station 12, cardiac MRI image data (DICOM data) at the end diastole / end systole is extracted (S30). In extracting this data, the cardiac cycle is equally divided into 10 to 14 by electrocardiogram R wave synchronization, and the maximum systolic time phase (end systole) is identified from the electrocardiogram R wave (end diastole). Then, each cross-sectional data in these two time phases is extracted, and each cross-sectional data is stored in separate folders prepared in the hard disk provided in the image processing workstation 12. Although this work involves manual operation, a series of work can be semi-automated by creating an extraction program (batch file) that performs this work collectively.

  When the creation of end-diastolic and end-systolic cardiac MRI image data (or cardiac CT image data) is thus completed, the cardiac MRI image data (or cardiac CT image data) is transferred to the CAD workstation 20 (S40). In step S 40, an examination by the cardiac ultrasound examination apparatus 14 is also performed, and cardiac ultrasound examination data obtained by this examination is also transferred to the CAD workstation 20. In the case of this embodiment, since these data transfers are from the main hospital to the manufacturer (manufacturing factory), the data is transferred via a communication line such as the Internet or a dedicated line. Otherwise, data may be transferred using a recording medium such as a DVD, or LAN transfer may be used when the manufacturing facility is located in a main hospital.

  Subsequently, in the CAD workstation 20, a boundary line is interpolated and extracted from the threshold value of the two-dimensional heart cross-sectional data (DICOM data) using the three-dimensional image construction software (S50). The process of extracting the boundary line is performed by the 3D image construction software based on the luminance information of the image. However, since the boundary sometimes shifts, the doctor verifies and corrects as necessary. These operations are performed for each of the diastolic sectional data and the systolic sectional data.

After the above operation, the CAD workstation 20 displays the three-dimensional data (S60).
After the expansion period form is set in this way, the boundary extraction data (three-dimensional data) is output and stored in the DXF file (S70). In the present embodiment, the 3D data is output as a binary data format DXF (Data eXchange Format) file according to the specifications of the 3D image construction software. However, the CAD workstation 21 for knitting machines requires data in a format different from the specification of the 3D image construction software.

  More specifically, in the case of the present embodiment, the computer-controlled flat knitting machine 22 is controlled based on a plurality of data each representing the shape of the pattern (hereinafter referred to as pattern data), and has a shape corresponding to each pattern. By knitting the knitted fabric and continuously knitting the knitted fabrics in the shape corresponding to each pattern, the three-dimensional knitted fabric can be knitted without sewing the inter-pattern portion separately. ing.

  Therefore, the CAD workstation 21 for the knitting machine that controls the computer-controlled flat knitting machine 22 cannot directly use the three-dimensional data that conforms to the specification of the three-dimensional image construction software, and conforms to the specification of the computer-controlled flat knitting machine 22. Pattern data is required.

  Therefore, in the CAD workstation 20, using general-purpose CAD software, the data format of the 3D data conforming to the specifications of the 3D image construction software is changed to the pattern data of the format conforming to the specifications of the computer controlled flat knitting machine 22. Conversion is performed (S80). Specifically, based on the 3D data that conforms to the specifications of the 3D image construction software, a vertical section is created at an appropriate boundary line (for example, the boundary line of the left ventricle and right ventricle), and is orthogonal to the vertical section. By measuring the outer circumference of the cross section, the pattern data representing the shape of the area divided by the boundary line is created.

  Further, when creating pattern data at the stage of S80, correction values are set, for example, adjusting the amount of heart stitching in consideration of cardiac ultrasound data. More specifically, for example, with the expansion of the heart, as shown in FIG. 4 (a), the diameter A2 of the mitral valve annulus is larger than the normal diameter A1. Then, this causes mitral regurgitation. Further, when the position of the papillary muscle is deviated to a position B2 that is outside or below the normal position B1, the mitral valve leaflet is deviated due to this, and mitral regurgitation occurs.

  Therefore, when creating pattern data in the stage of S80, based on the data of cardiac ultrasound, the anteroposterior diameter of the mitral valve annulus becomes the diameter A1 when normal, and the position of the papillary muscle is normal. The actually measured three-dimensional data of the heart is corrected so as to be at the position B1. By optimizing the shape of the heart morphological correction net 1 by the work on the CAD workstation 20 as described above, the amount of mitral valve annulus stitches can be optimized and the papillary muscle position can be corrected. it can.

  When the three-dimensional data conforming to the specifications of the three-dimensional image construction software is converted into the pattern data in a format conforming to the specifications of the computer controlled flat knitting machine 22 by the above procedure, the CAD workstation 21 for the knitting machine is converted into the pattern data. The data is transferred to (S90). This data transfer may be performed via a network such as a LAN (Local Area Network) or a recording medium such as a DVD (Digital Versatile Disk).

In the CAD workstation 21 for knitting machines that has received the three-dimensional data of the heart, the operator inputs the stitch size and instructions for knitting (S100).
More specifically, as the size of the stitches (open area of the stitches) generally decreases, the tension per stitch decreases and the tear resistance increases. However, the living body has a fiber forming action against foreign substances, and if the surface of the heart is covered with a small cloth with a small mesh, fibers are formed on the surface of the heart without any gaps, and the contraction and relaxation of the heart are damaged. Become. Therefore, there is a need for a stitch size (an open area of the eyelet) that leaves an open space that does not damage the contraction and relaxation of the heart.

  However, if the area of the mesh is too large, there is a risk that the fibers may bite into the heart muscle and a localized ventricular aneurysm may be formed due to insufficient expansion of the enlarged and increased wall tension heart. If the stitches are too large, the fibers may block the coronary blood vessels locally, so that the blood flow may be impaired. Therefore, there exists an optimal stitch size that does not cause excessive fiber formation on the heart surface, does not disturb local coronary blood flow, and does not form a ventricular aneurysm.

The stitch size depends on the thickness of the yarn and the elastic force, but is generally 1 to 100 mm ² , more generally 3 to 10 mm ² . The knitting method depends on the knitting machine to be used. For example, the computer-controlled weft knitting machine 22 employed in the present embodiment can use tengu knitting and mesh knitting.

  Tendon knitting has high tensile resistance in the horizontal direction and low tensile resistance in the vertical direction. For this reason, it is suitable for constraining a heart with a large lateral movement. However, since the stitches are clogged in ordinary tentacle knitting, a knitting machine having a large needle pitch (needle gauges 7G, 10G) is used, or the needle pitch is adjusted. Needle-punched knitting must be used with a small knitting machine (needle gauge 15G).

  In mesh knitting, the degree of freedom for setting the open area of the mesh is greater than that of a tengu knitting made with a knitting machine having the same needle pitch. Therefore, it is possible to set the open area of the meshes separately from the apex, the middle, and the base of the heart with different lateral contraction rates for each region. In other words, a more appropriate correction of the heart shape is possible by making the middle part that contracts greatly into a large mesh structure and making the heart base and apex into a small mesh structure. These stitch size and knitting method items are input to the CAD workstation 21 for the knitting machine.

  When the above items are input, the knitting data based on the three-dimensional data is completed, and a control command based on the knitting data is transmitted from the knitting machine CAD workstation 21 to the computer controlled flat knitting machine 22 (S110). Alternatively, the control command as described above is input to the computer-controlled flat knitting machine 22 via an external storage medium. As a result, the knitting yarn is knitted in the computer-controlled flat knitting machine 22, and the heart shape correction net 1 having a three-dimensional shape is knitted.

  The material of the thread is a material with high biocompatibility. For example, polyester, polytetrafluoroethylene, expanded polytetrafluoroethylene (expanded PTFE, ePTFE), polypropylene, polydifluoroethylene (hexafluoropropylene-vinylidene fluoride), and the like are suitable. Or the composite fiber material which used the fiber (for example, aromatic polyamide fiber) whose intensity | strength was more excellent in order to improve fatigue resistance and disconnection resistance may be sufficient. The material of the yarn is preferably 70 dtex or more.

  When the heart shape correction net 1 is knitted in this way, the knitted product is sterilized and packaged (S120), thereby completing the product. The finished product will be delivered to the ordering hospital.

  As described above, the heart shape correction net 1 can regulate excessive expansion of the heart 3 by accommodating a part of the heart 3 inside and surrounding the accommodated part from the outside. . Moreover, the knitted fabric of the heart shape correction net 1 is obtained by photographing the three-dimensional shape of the heart 3 for each patient by the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector type CT diagnostic apparatus 11 ′). The knitting data based on the three-dimensional data is knitted by giving it to the computer-controlled flat knitting machine 22.

  Therefore, according to the heart shape correction net 1 configured as described above, the knitted fabric is in a form that matches the three-dimensional shape of the heart 3, so that there are individual differences in the size and shape of the heart 3 for each patient. Will also have a form that fits perfectly with each patient. Therefore, unlike a general-purpose heart shape correction network as described in Patent Document 1 described above, it is not necessary to excise unnecessary portions in accordance with the size of the patient's heart 3 during the operation. Can reduce the burden on the patient.

  In addition, even if the surgeon does not judge the degree of squeezing during the operation, the form of the heart morphological correction net 1 is designed on the CAD workstation 20 to optimize the mitral valve annulus squeeze amount and the position of the papillary muscles. Corrections can be made. Specifically, as shown in FIG. 4B, the front and rear diameters of the mitral valve annulus can be returned to the normal diameter A1 by attaching the heart shape correction net 1, and the position of the papillary muscles Can be returned to the normal position B1. Therefore, it is not necessary to perform a major operation such as repairing the mitral valve annulus from the inner surface of the heart using an artificial annulus under cardiopulmonary arrest, thus suppressing the increase in patient invasion and medical costs. In addition, variation in results can be suppressed.

  Furthermore, even if the heart 3 is not reversed and attached, it can be fitted to the heart exactly, so the burden on the patient can be reduced in this respect as well, and the surgical cost for the heart-lung machine etc. is also suppressed. be able to.

  As mentioned above, although embodiment of this invention was described, this invention is not limited to said specific one Embodiment, In addition, it can implement with a various form. In the following, another useful embodiment will be described.

  In the said embodiment, although the heart shape correction net | network 1 was mentioned as an example of the medical device of this invention, the structure of this invention can be employ | adopted also in the medical device used for a use different from the heart shape correction net | network 1. it can.

  For example, the medical instrument of the present invention may be used as an artificial blood vessel that replaces a part of a blood vessel. In this case, the knitted fabric forms the three-dimensional shape of the blood vessel for each patient on the basis of the nuclear magnetic resonance diagnosis. The knitting data based on the three-dimensional data obtained by photographing with the apparatus 11 (or the multi-row detector CT diagnostic apparatus 11 ′) is knitted by giving the knitting data to the computer-controlled flat knitting machine 22. Good.

  When configured as an artificial blood vessel, a knitted fabric in which gaps between the knitted yarns are clogged with blood is knitted by knitting knitting yarns thinner than the heart shape correction net 1 at a high density. In order to prevent blood from leaking between the yarns during the operation, a structure in which collagen or gelatin is filled in the gaps of the yarns in advance may be employed.

  According to the medical device configured in this way, the knitted fabric has a form that matches the three-dimensional shape of the blood vessel. Therefore, unlike a simple tubular artificial blood vessel, the blood vessel has complicated unevenness and has a complicated shape. Since an artificial blood vessel having a shape equivalent to a curved blood vessel can be formed, a blood vessel having a lesion can be replaced with an artificial blood vessel in a more natural manner.

  To give a more specific example, for example, as shown in FIG. 5, it has a complicated form like the base of the aorta (a complicated form having three bulges called Valsalva sinus and an aortic valve inside). Even if it is a blood vessel, the artificial blood vessel 31 which has a form equivalent to this aortic base part can be comprised. Such an artificial blood vessel 31 can be used in aortic root artificial blood vessel replacement.

  In addition to the base of the aorta, for example, there are complex blood vessels having branches and inflection points, such as the arch aorta and the abdominal aorta. Various forms of artificial blood vessels can be constructed. Therefore, such an artificial blood vessel can be used in an arch aortic artificial blood vessel replacement, an abdominal aorta Y-shaped artificial blood vessel replacement, or the like.

  In the above embodiment, the nuclear magnetic resonance diagnostic apparatus 11 (or the multi-row detector CT diagnostic apparatus 11 ′), the image processing workstation 12, and the cardiac ultrasound examination apparatus 14 are installed on the basic hospital side. Although the example which installed the CAD workstation 20, the CAD workstation 21 for knitting machines, and the computer controlled flat knitting machine 22 on the maker (manufacturing factory) side was shown, which apparatus was installed in the hospital side and which apparatus was manufactured (manufacturing factory It is optional whether it is installed on the side).

  For example, a nuclear magnetic resonance diagnostic apparatus 11 (or a multi-row detector CT diagnostic apparatus 11 ′), an image processing workstation 12, a cardiac ultrasonography apparatus 14, and a CAD workstation 20 are installed on the main hospital side. Then, the CAD workstation 21 for knitting machines and the computer-controlled flat knitting machine 22 may be installed on the manufacturer (manufacturing factory) side. In this way, the final three-dimensional data is completed on the basic hospital side, so that the manufacturer (manufacturing factory) does not need a high-level judgment by a cardiac surgeon.

  However, in this case, the work burden on the individual hospitals will increase correspondingly, so a system can be constructed that can easily carry out the extraction of heart surface data and the setting of correction values at the hospitals. It is important to reduce the burden on the main hospital. Further, if such a system is adopted and the work burden on the individual core hospital side becomes excessive, as in the embodiment described above, the manufacturer (manufacturing factory) side makes a somewhat advanced judgment. It is beneficial to have a system that can

  In the above embodiment, a specific manufacturer's computer-controlled flat knitting machine 22 and some specific manufacturer's software have been exemplified. It goes without saying that the present invention can be implemented even if is used.

(A) is a perspective view of the heart form correction net | network equivalent to an example of the medical device of this invention, (b) is a perspective view which shows the state which mounted | wore the heart shape correction net | network with the heart. The block diagram which shows the manufacturing equipment of the medical device of this invention. The flowchart which shows the manufacture procedure of the medical device of this invention. (A) is an explanatory view showing the state of the heart in which mitral regurgitation has occurred, (b) is a morphological correction net that optimizes the anteroposterior diameter of the mitral valve annulus and corrects the position of the papillary muscles Explanatory drawing which shows the state made. The perspective view which shows the use condition of the artificial blood vessel corresponded to another example of the medical device of this invention.

Explanation of symbols

  DESCRIPTION OF SYMBOLS 1 ... Heart shape correction network, 11 ... Nuclear magnetic resonance diagnostic apparatus, 11 '... Multi-row detector type CT diagnostic apparatus, 12 ... Image processing workstation, 14 ... Cardiac ultrasound examination Equipment: 20 ... CAD workstation, 21 ... CAD workstation for knitting machine, 22 ... Computer controlled flat knitting machine, 31 ... Artificial blood vessel.

Claims (6)

The knitting based on the three-dimensional data obtained by measuring the three-dimensional shape of the application target part for each patient with respect to the knitting machine capable of knitting the knitting yarn into a three-dimensional shape based on the knitting data representing the three-dimensional shape. A medical device characterized by being constituted by a knitted fabric knitted by giving data. A medical device used as a heart morphological correction net that regulates excessive expansion of the heart by accommodating a part of the heart inside and surrounding the accommodated part from the outside,
The knitting fabric is obtained by adding a correction value obtained according to a case for each patient to the three-dimensional data obtained by photographing the three-dimensional shape of the heart with a tomography apparatus for each patient. The medical device according to claim 1, wherein the medical device is knitted by giving data to the knitting machine. A medical device used as an artificial blood vessel that replaces part of a blood vessel,
The knitted fabric is knitted by providing the knitting machine with the knitting data based on the three-dimensional data obtained by photographing the three-dimensional shape of a blood vessel with a tomography apparatus for each patient. The medical device according to claim 1. The knitting yarn is composed of any one or more selected from polyester, polytetrafluoroethylene, foamed polytetrafluoroethylene, polypropylene, and polydifluoroethylene (hexafluoropropylene-vinylidene fluoride). The medical device according to any one of claims 1 to 3, wherein A first step of photographing a plurality of tomographic images with a tomography apparatus;
A second step of extracting an outline of an application target site in each tomographic image obtained in the first step;
A third step of creating three-dimensional data representing the three-dimensional shape of the application target part based on the contour extracted in the second step;
By applying the knitting data based on the three-dimensional data created in the third step to a knitting machine capable of knitting a knitting yarn into a three-dimensional shape based on knitting data representing a three-dimensional shape, the application object And a fourth step of knitting a knitted fabric having a shape that matches the part. The fourth step provides the knitting machine with the knitting data obtained by adding a correction value obtained according to a case for each patient to the three-dimensional data created in the third step. The method of manufacturing a medical device according to claim 5, wherein the knitting fabric is knitted.

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