Source: http://www.google.com/patents/US7056276?dq=5166694
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Patent US7056276 - Catheter for radiation therapy - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsIn an expandable part positioned on the tip end side of the catheter, protruding parts are produced in specific regions when the expandable part is expanded through the difference in elasticity between two materials having a different elasticity to one another. The structure is made to be such that low-elasticity...http://www.google.com/patents/US7056276?utm_source=gb-gplus-sharePatent US7056276 - Catheter for radiation therapyAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS7056276 B2Publication typeGrantApplication numberUS 10/333,051PCT numberPCT/JP2001/005155Publication dateJun 6, 2006Filing dateJun 15, 2001Priority dateAug 2, 2000Fee statusLapsedAlso published asCA2417700A1, CN1262319C, CN1446113A, EP1321161A1, US20030176758, WO2002011805A1Publication number10333051, 333051, PCT/2001/5155, PCT/JP/1/005155, PCT/JP/1/05155, PCT/JP/2001/005155, PCT/JP/2001/05155, PCT/JP1/005155, PCT/JP1/05155, PCT/JP1005155, PCT/JP105155, PCT/JP2001/005155, PCT/JP2001/05155, PCT/JP2001005155, PCT/JP200105155, US 7056276 B2, US 7056276B2, US-B2-7056276, US7056276 B2, US7056276B2InventorsRyoji Nakano, Takuya IshibashiOriginal AssigneeKaneka CorporationExport CitationBiBTeX, EndNote, RefManPatent Citations (14), Referenced by (27), Classifications (18), Legal Events (4) External Links: USPTO, USPTO Assignment, EspacenetCatheter for radiation therapy
US 7056276 B2Abstract
In an expandable part positioned on the tip end side of the catheter, protruding parts are produced in specific regions when the expandable part is expanded through the difference in elasticity between two materials having a different elasticity to one another. The structure is made to be such that low-elasticity regions and high-elasticity regions are disposed in the expandable part, and when pressure is applied the high-elasticity regions expand more than the low-elasticity regions, thus becoming the protruding parts. Alternatively, the structure is made to be such that two materials having a different elasticity to one another are made into a two-layer structure of an inner layer and an outer layer, and voids are provided in the layer formed from the low-elasticity material, so that when pressure is applied, parts of the layer formed from the high-elasticity material corresponding to the void parts become the protruding parts.
6. The catheter for radiation therapy according to any of claims 1 through 3, wherein when said expandable part is expanded, a plurality of pairs of protruding parts are produced, with the protruding parts that constitute each pair being disposed so as to be produced facing in opposite directions to one another in a direction orthogonal to the axial direction of said expandable part, and with pairs of protruding parts that are adjacent to one another in the axial direction being disposed close to one another with an angle of 90° therebetween in the circumferential direction.
7. The catheter for radiation therapy according to any of claims 1 through 3, wherein when said expandable part is expanded, a plurality of pairs of protruding parts are produced, with the protruding parts that constitute each pair being disposed so as to be produced facing in opposite directions to one another in a direction orthogonal to the axial direction of said expandable part, and with pairs of protruding parts that are adjacent to one another in the axial direction being disposed in spiral fashion close to one another with an angle of less than 90° therebetween in the circumferential direction.
The present invention relates to a catheter for radiation therapy for treating part of a body vessel with ionizing radiation.
A widely carried out therapy for stenosis of blood vessels, in particular stenosis of the coronary artery, which is a cause of myocardial infarction, angina pectoris and so on, is to expand the stenosed part using a catheter having a balloon disposed on the tip thereof, which is known as a PTCA (percutaneous transluminal coronary angioplasty) balloon catheter. Describing this technique in more detail, first a hollow φ2 mm to φ3 mm catheter called a guiding catheter for leading in the PTCA balloon catheter is led into the aorta, and the tip thereof is disposed at the entrance of the coronary artery. Next, a wire of outside diameter φ0.010″ (0.254 mm) to 0.018″ (0.457 mm) which is called a guide wire and fulfills a role of guiding the PTCA balloon catheter is led into the guiding catheter, and is passed through the stenosed part of the coronary artery. Then, the PTCA balloon catheter having the balloon disposed on the tip thereof is led in along the guide wire as far as the coronary artery, is similarly passed through the stenosed part, and the balloon part of the PTCA balloon catheter is disposed in the stenosed part. The balloon is then expanded using high-pressure physiological saline, contrast medium or the like, thus forcibly opening up the stenosed part.
It is an object of the present invention to provide a catheter for radiation therapy according to which the problems described above can be avoided or reduced. That is, it is an object of the present invention to provide a catheter for radiation therapy that has a centering mechanism that enables blood vessel walls to be irradiated with a uniform radiation dose, and has a perfusion mechanism that allows blood to flow to peripheral blood vessels at all times during centering, and for which there are no undulations on the surface of the catheter when the catheter is being moved through a blood vessel, and hence there is little resistance to movement through the blood vessel, and there is no risk of the inner surface of the blood vessel being damaged, and moreover for which manufacture is easy.
With one means of the catheter for radiation therapy according to the present invention, the expandable part positioned on the tip end side has high-elasticity regions and low-elasticity regions, the bend elastic constant as measured using a measurement method based on ASTM-D790 is set to be at least 20% higher for the low-elasticity regions than for the high-elasticity regions, one or a plurality of voids are present in parts of the outer layer, the expandable part has no protruding parts on the surface thereof when not expanded, and parts of the inner layer protrude from the voids of the outer layer when the expandable part is expanded. Here, ‘high-elasticity’ is defined as a property whereby in general a large elastic deformation can be achieved, i.e. means the property of a substance for which in practice the amount of deformation in response to an applied force is large. Moreover, ‘low-elasticity’ is defined as the opposite property to high-elasticity. Furthermore, ‘elastic constant’ is defined as σ/e for when the elastic strain e is proportional to the corresponding stress σ. Consequently, high elastic constant and low elasticity have the same meaning, and low elastic constant and high elasticity have the same meaning. With the present invention, taking the value of the bend elastic constant of the high-elasticity substance or high-elasticity regions as measured using a measurement method based on ASTM-D790 to be a, and taking the value of the bend elastic constant of the low-elasticity substance or low-elasticity regions as measured using a measurement method based on ASTM-D790 to be b, the relationship b/a≧1.2 holds. The above-mentioned protruding parts have as an objective thereof making perfusion of a body fluid possible, and moreover positioning in the center in the radial direction a radiation source that has been disposed inside the expandable part; the materials of the inner and outer layers, the thicknesses of the inner and outer layers, and the number, size, shape and pattern of arrangement of the voids in the outer layer can be selected as desired so long as this objective is realized. Preferably, the outside diameter expansion rate per unit expansion pressure is at least 25.0%/atm (0.247%/kPa) in regions where protruding parts are produced, and not more than 2.5%/atm (0.0247%/kPa) in regions where protruding parts are not produced; in this case, it is possible to maintain sufficient biological perfusion at a low pressure from 1 atm (1.013×105 Pa) to 3 atm (3.040×105 Pa) (gauge pressure) that is easy for a surgeon to handle. Hereinafter, all pressures in the present invention are expressed as gauge pressures.
With another means of the catheter for radiation therapy according to the present invention, the expandable part positioned on the tip end side has high-elasticity regions and low-elasticity regions, the bend elastic constant as measured using a measurement method based on ASTM-D790 is set to be at least 20% higher for the low-elasticity regions than for the high-elasticity regions, the expandable part has no protruding parts on the surface thereof when not expanded, and protruding parts are produced through the difference in elasticity when the expandable part is expanded. The protruding parts have as an objective thereof making perfusion of a body fluid possible, and moreover positioning in the center in the radial direction a radiation source that has been disposed inside the expandable part; the material, thickness, number, size, shape and pattern of arrangement of the relatively-high-elasticity regions can be selected as desired so long as this objective is realized, and moreover the size, shape and pattern of arrangement of the relatively-low-elasticity regions can be selected as desired so long as this objective is realized. Preferably, the outside diameter expansion rate per unit expansion pressure is at least 25.0%/atm (0.247%/kPa) in regions where protruding parts are produced, and not more than 2.5%/atm (0.0247%/kPa) in regions where protruding parts are not produced; in this case, it is possible to maintain sufficient biological perfusion at a low pressure from 1 atm (1.013×105 Pa) to 3 atm (3.040×105 Pa) that is easy for a surgeon to handle.
With yet another means of the catheter for radiation therapy according to the present invention, the expandable part positioned on the tip end side has a two-layer structure in a radial direction of an inner layer and an outer layer both formed from an elastic substance, the bend elastic constant as measured using a measurement method based on ASTM-D790 is set to be at least 20% higher for the inner layer than for the outer layer, one or a plurality of voids are present in parts of the inner layer, the expandable part has no protruding parts on the surface thereof when not expanded, and parts of the outer layer corresponding to parts where the voids are present in the inner layer protrude when the expandable part is expanded. The protruding parts have as an objective thereof making perfusion of a body fluid possible, and moreover positioning in the center in the radial direction a radiation source that has been disposed inside the expandable part; the number, size, shape and pattern of arrangement of the voids in the inner layer can be selected as desired so long as this objective is realized. Preferably, the outside diameter expansion rate per unit expansion pressure is at least 25.0%/atm (0.247%/kPa) in regions where protruding parts are produced, and not more than 2.5%/atm (0.0247%/kPa) in regions where protruding parts are not produced; in this case, it is possible to maintain sufficient biological perfusion at a low pressure from 1 atm (1.013×105 Pa) to 3 atm (3.040×105 Pa) that is easy for a surgeon to handle.
FIG. 1 is an axial direction sectional view of a first example.
Following is a description of various embodiments of the catheter according to the present invention with reference to the drawings.
A first example of FIG. 1 is a catheter for radiation therapy for treating part of a body vessel with ionizing radiation; a state in which the expandable part has been expanded is shown. The expandable part 1 of the catheter is positioned on the tip end side of the catheter, and in the expanded state has a plurality of protruding parts 2. Specifically, when the expandable part 1 is expanded, a plurality of pairs of protruding parts 2 are produced, with the protruding parts 2 that constitute each pair being disposed so as to be produced facing in opposite directions to one another in a direction orthogonal to the axial direction of the expandable part 1, and moreover with pairs of protruding parts 2 that are adjacent to one another in the axial direction being disposed close to one another with an angle of 90° therebetween in the circumferential direction. In the example shown in the drawing, there are five pairs of protruding parts 2 in succession in the axial direction with angles of 90° between adjacent pairs, and hence the catheter of the first example has a total of ten protruding parts 2. Moreover, the outline of each of the protruding parts as viewed from the direction of protrusion of the protruding part is approximately circular. In other words, the shape of each of the protruding parts 2 as viewed from the perpendicular direction of the protruding part 2 in the radial direction is approximately circular. Through the protruding parts 2, even in the case of a curved body vessel, a radiation source tubular cavity 6 is disposed in the center of the body vessel at all times, and hence irradiation can be carried out with a uniform dose.
As shown in FIGS. 3 and 4, the expandable part comprises an inner layer 21 of relatively high elasticity and an outer layer 22 of relatively low elasticity, and the outer layer 22 has voids 23. Here, the relatively high elasticity and the relatively low elasticity means that the relative difference between the bend elastic constants as measured using a measurement method based on ASTM-D790 is at least 20%, and is as described earlier (likewise hereinafter). Moreover, inside the inner layer 21 there is an inner tube 24 that forms the radiation source tubular cavity 26. An inflation lumen 25 is formed between the inner layer 21 and the inner tube 24. The inflation lumen 25 communicates with the inflation port at the base end part of the catheter, and upon a surgeon carrying out an operation of introducing a contrast medium, physiological saline or the like into the expandable part 1 to apply pressure, the inner layer 21 expands, thus becoming the protruding parts 2. The inner layer 21 was made using a thermoplastic polyurethane elastomer E380 made by Nippon Miractran, and the outer layer 22 was made using a polyamide elastomer Pebax 7033 made by Atochem. The inner layer 21 and the outer layer 22 were joined together using a urethane adhesive UR0531 made by H. B. Fuller. The voids 23 provided in the outer layer 22 were made to have a diameter of 1.9 mm. The diameter of the voids 23 is not the diameter when looking from one direction at the void 23 existing on a curved surface, but rather is the diameter when the expandable part 1 is spread out so that the void 23 becomes planar. Moreover, the expandable part 1 was made such that the outside diameter before expansion was 1.50 mm. When the catheter was expanded with a pressure of 1.0 atm (1.013×105 Pa), the outside diameter of the protruding parts 2 was 1.98 mm, and the outside diameter of parts where protruding parts 2 are not present was 1.52 mm. Moreover, when the catheter was expanded with a pressure of 2.0 atm (2.027×105 Pa), the outside diameter of the protruding parts 2 was 2.63 mm, and the outside diameter of parts where protruding parts 2 are not present was 1.55 mm. Furthermore, when the catheter was expanded with a pressure of 3.0 atm (3.040×105 Pa), the outside diameter of the protruding parts 2 was 3.30 mm, and the outside diameter of parts where protruding parts 2 are not present was 1.57 mm.
The following evaluation was carried out on the first example. Three mock blood vessels made of urethane and of inside diameter 2.5 mm, angle 180°, and radius of curvature 30 mm, 20 mm or 10 mm were prepared. The catheter of the first example was disposed in each mock blood vessel, and a pressure of 2.0 atm (2.027×105 Pa) or 3.0 atm (3.040×105 Pa) was applied to the catheter. For each of the above-mentioned mock blood vessels and each of the above-mentioned pressures, a mock radiation source was inserted into the radiation source tubular cavity 6, and it was verified that the mock radiation source was positioned in the center in the radial direction in all parts of the mock blood vessel. Moreover, physiological saline that had been colored red was made to flow into the mock blood vessel at a pressure difference of 16.0 kPa, and for each of the above-mentioned mock blood vessels and each of the above-mentioned pressures, it was verified that perfusion of the physiological saline occurred.
A second example of FIG. 5 is a catheter for radiation therapy for treating part of a body vessel with ionizing radiation; a state in which the expandable part 51 has been expanded is shown. The expandable part 51 of the catheter is positioned on the tip end side of the catheter, and in the expanded state has a plurality of pairs of protruding parts 52. Specifically, when the expandable part 51 is expanded, a plurality of pairs of protruding parts 52 are produced, with the protruding parts 52 that constitute each pair being disposed so as to be produced facing in opposite directions to one another in a direction orthogonal to the axial direction of the expandable part 51, and moreover with pairs of protruding parts that are adjacent to one another in the axial direction being disposed in spiral fashion close to one another with an angle of less than 90° therebetween in the circumferential direction. In the example shown in the drawing, there are five pairs of protruding parts 52 in succession in the axial direction with angles of 45° between adjacent pairs, and hence the pairs of protruding parts 52 are formed in spiral fashion in the axial direction. Through the protruding parts 52, even in the case of a curved body vessel, a radiation source tubular cavity 56 is disposed in the center of the body vessel at all times, and hence irradiation can be carried out with a uniform dose.
As shown in FIGS. 6 and 7, the expandable part 51 is a tube comprising relatively-high-elasticity regions 61 and relatively-low-elasticity regions 62. Moreover, inside there is an inner tube 64 that forms the radiation source tubular cavity 66. An inflation lumen 65 is formed between the inner tube 64 and the tube comprising the relatively-high-elasticity regions 61 and the relatively-low-elasticity regions 62. The inflation lumen 65 communicates with the inflation port at the base end part of the catheter, and upon a surgeon carrying out an operation of introducing a contrast medium, physiological saline or the like into the expandable part 51 to apply pressure, the relatively-high-elasticity regions 61 expand, thus becoming the protruding parts 52. The relatively-high-elasticity regions 61 were made using a thermoplastic elastomer E380 made by Nippon Miractran, and the relatively-low-elasticity regions 62 were made using a thermoplastic elastomer E395 made by Nippon Miractran. Fabrication was carried out by dipping a tube made of E395 in which prescribed voids had been formed into a liquid of E380, wiping off the E380 attached to parts other than the parts where the voids were, and drying. The relatively-high-elasticity regions 61 were made to have a diameter of 1.0 mm. The diameter of the relatively-high-elasticity regions 61 is not the diameter when looking from one direction at the relatively-high-elasticity region 61 existing on a curved surface, but rather is the diameter when the expandable part is spread out so that the relatively-high-elasticity region 61 becomes planar. Moreover, the expandable part was made such that the outside diameter before expansion was 1.00 mm. When the catheter was expanded with a pressure of 1.0 atm (1.013×105 Pa), the outside diameter of the protruding parts 52 was 1.25 mm, and the outside diameter of parts where protruding parts 52 are not present was 1.02 mm. Moreover, when the catheter was expanded with a pressure of 2.0 atm (2.027×105 Pa), the outside diameter of the protruding parts 52 was 1.54 mm, and the outside diameter of parts where protruding parts 52 are not present was 1.03 mm. Furthermore, when the catheter was expanded with a pressure of 3.0 atm (3.040×105 Pa), the outside diameter of the protruding parts 52 was 1.81 mm, and the outside diameter of parts where protruding parts 52 are not present was 1.06 mm.
The following evaluation was carried out on the second example. Three mock blood vessels made of urethane and of inside diameter 1.5 mm, angle 180°, and radius of curvature 30 mm, 20 mm or 10 mm were prepared. The catheter of the second example was disposed in each mock blood vessel, and a pressure of 2.0 atm (2.027×105 Pa) or 3.0 atm (3.040×105 Pa) was applied to the catheter. For each of the above-mentioned mock blood vessels and each of the above-mentioned pressures, a mock radiation source was inserted into the radiation source tubular cavity 66, and it was verified that the mock radiation source was positioned in the center in the radial direction in all parts of the mock blood vessel. Moreover, physiological saline that had been colored red was made to flow into the mock blood vessel at a pressure difference of 16.0 kPa, and for each of the above-mentioned mock blood vessels and each of the above-mentioned pressures, it was verified that perfusion of the physiological saline occurred.
A third example of FIG. 8 is a catheter for radiation therapy for treating part of a body vessel with ionizing radiation; a state in which the expandable part 81 has been expanded is shown. The expandable part 81 of the catheter is positioned on the tip end side of the catheter, and in the expanded state has a plurality of protruding parts 82. Specifically, when the expandable part 81 is expanded, a plurality of pairs of protruding parts 82 are produced, with the protruding parts 82 that constitute each pair being disposed so as to be produced facing in opposite directions to one another in a direction orthogonal to the axial direction of the expandable part 81, and moreover with pairs of protruding parts 82 that are adjacent to one another in the axial direction being disposed close to one another with an angle of 90° therebetween in the circumferential direction. In the example shown in the drawing, there are four pairs of protruding parts 82 in succession in the axial direction with angles of 90° between adjacent pairs, and hence the catheter of the third example has a total of eight protruding parts 82. Through the protruding parts 82, even in the case of a curved body vessel, a radiation source tubular cavity 86 is disposed in the center of the body vessel at all times, and hence irradiation can be carried out with a uniform dose. Moreover, the outline of each of the protruding parts 82 as viewed from the direction of protrusion of the protruding part 82 is elliptical. In other words, the shape of each of the protruding parts 82 is an ellipse that is long in the axial direction as viewed from the perpendicular direction of the protruding part 82 in the radial direction. By making the shape be an ellipse, the centering performance and the perfusion performance can be made to be better than in the case of a circular shape, and moreover the sliding ability of the catheter can be improved.
The inner layer 91 was made using a polyamide elastomer Pebax 7033 made by Atochem, and the outer layer 92 was made using a thermoplastic polyurethane elastomer E380 made by Nippon Miractran. The inner layer 91 and the outer layer 92 were joined together using a urethane adhesive UR0531 made by H. B. Fuller. The voids 93 provided in the inner layer 91 were made to have a short diameter of 1.0 mm, and a long diameter of 1.4 mm. The short diameter and the long diameter of the voids 93 are not the short diameter and the long diameter when looking from one direction at the void 93 existing on a curved surface, but rather are the short diameter and the long diameter when the expandable part 81 is spread out so that the void 93 becomes planar. Moreover, the expandable part 81 was made such that the outside diameter before expansion was 1.25 mm. When the catheter was expanded with a pressure of 1.0 atm (1.013×105 Pa), the outside diameter of the protruding parts 82 was 1.58 mm, and the outside diameter of parts where protruding parts 82 are not present was 1.26 mm. Moreover, when the catheter was expanded with a pressure of 2.0 atm (2.027×105 Pa), the outside diameter of the protruding parts 82 was 2.02 mm, and the outside diameter of parts where protruding parts 82 are not present was 1.28 mm. Furthermore, when the catheter was expanded with a pressure of 3.0 atm (3.040×105 Pa), the outside diameter of the protruding parts 82 was 2.47 mm, and the outside diameter of parts where protruding parts 82 are not present was 1.31 mm.
The following evaluation was carried out on the third example. Three mock blood vessels made of urethane and of inside diameter 2.0 mm, angle 180°, and radius of curvature 30 mm, 20 mm or 10 mm were prepared. The catheter of the third example was disposed in each mock blood vessel, and a pressure of 2.0 atm (2.027×105 Pa) or 3.0 atm (3.040×105 Pa) was applied to the catheter. For each of the above-mentioned mock blood vessels and each of the above-mentioned pressures, a mock radiation source was inserted into the radiation source tubular cavity 96, and it was verified that the mock radiation source was positioned in the center in the radial direction in all parts of the mock blood vessel. Moreover, physiological saline that had been colored red was made to flow into the mock blood vessel at a pressure difference of 16.0 kPa, and for each of the above-mentioned mock blood vessels and each of the above-mentioned pressures, it was verified that perfusion of the physiological saline occurred.
By adopting a structure as in the present invention in which a part that expands comprises two materials having a different elasticity to one another, and due to this elasticity difference, the part that expands has a surface with no level differences thereon when not expanded, but when expanded high-elasticity parts in specific regions expand to produce protruding parts, a radiation source can be positioned in the central part of a blood vessel at all times, perfusion of a body fluid is possible, and moreover because the outer surface has no undulations, the risk of the inner walls of the blood vessel being damaged is reduced.
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