JP2020146387A - Medical device - Google Patents

Abstract

To provide a medical device capable of improving operability of another long device by suppressing generation of excessive bend and friction of the other long device.SOLUTION: A medical device 10 formed with a lumen 36 in which a long treatment device 90 can be inserted, comprises: a shaft 20 having a tip end and a base end; and a tubular body 30 that includes a tip-end opening 33, a base-end opening 34, and a wall part 35 extending between the tip-end opening 33 and the base-end opening 34 and forming the lumen 36, and that is fixed to the tip end of the shaft 20. The wall part 35 includes a first groove 41, a second groove 42, a third groove 43, and a fourth groove 44 extending in the circumferential direction Y, formed at an outer peripheral surface of the tubular body 30.SELECTED DRAWING: Figure 3

Description

The present invention relates to medical devices that support other long devices that are inserted into the body.

In the treatment of the common bile duct, interventional treatment using an endoscope has become the mainstream. In endoscopy and endoscopic surgery in the common bile duct, the surgeon first moves the endoscope from the patient's mouth to the duodenum and then from the duodenum to the common bile duct (hereinafter referred to as the entrance branch). Insert up to the vicinity of). Next, the surgeon inserts a long treatment device such as a catheter or a guide wire into the common bile duct endoscopically to examine and treat the lesion. Due to the steep angle of the entrance bifurcation of the common bile duct, the treatment device bends at the entrance bifurcation, causing friction between the treatment device and the entrance bifurcation. In interventional treatment, it is necessary to transmit the torque applied to the base end of the treatment device to the tip. The occurrence of bending and friction of the treatment device impairs the operability of the treatment device and may interfere with the treatment.

In order to improve the insertability of the treatment device into the entrance branch, in the treatment in the common bile duct, a procedure of expanding the entrance branch by a support device such as a support catheter is performed.

Further, for example, Patent Document 1 describes a support device that expands the entrance branch by a tube that self-expands at the entrance of the common bile duct. The tube is woven by a spiral wire.

Japanese Patent Application Laid-Open No. 2013-529107

However, the support device arranged at the entrance branch is greatly bent at the entrance branch. Therefore, when the operator pushes the support device to insert it into the common bile duct, the support device may be pushed toward the lower duodenum at the flexion of the entrance bifurcation. In this case, the support device has a large bend at the inlet branch. As the flexion of the support device increases, so does the flexion of the treatment device through the lumen of the support device.

Also, when the operator inserts the treatment device into the common bile duct, the treatment device may be excessively flexed in the lumen of the support device.

In addition, there are individual differences in the shape of the entrance branch. Therefore, when the angle of the entrance branch is steep, the support device and the therapeutic device are likely to be excessively bent at the entrance branch.

The present invention has been made to solve the above-mentioned problems, and is a medical device capable of suppressing excessive bending and friction of other long devices and improving the operability of other devices. provide.

The medical device according to the present invention that achieves the above object is a medical device in which a lumen through which another long device can be inserted is formed, and is a shaft having a tip portion and a proximal end portion, a tip opening, and a base. A tubular body comprising an end opening and a wall portion extending between the tip opening and a proximal end opening to form a lumen and fixed to the tip of the shaft, wherein the wall is tubular. It is characterized in that at least one groove extending in the circumferential direction is formed on the outer peripheral surface of the body.

The medical device configured as described above can flexibly bend following the support device by the groove formed on the outer peripheral surface of the lumen body. When the tubular body is bent until the groove edges of the grooves adjacent to each other in the long axis direction come into contact with each other, bending beyond a predetermined total bending angle is restricted. Therefore, the tubular body has a minimum bending radius defined. As a result, the present medical device can suppress the occurrence of excessive bending and friction of the treatment device inserted into the tubular body, and can improve the operability of the treatment device.

The minimum bending radius, which is the distance from the bending center of the tubular body to the groove edge portion in a state where the groove edges of the grooves facing each other in the long axis direction of the tubular body are in contact with each other, is 2 to 12 mm. You may. Thereby, the medical device can support the therapeutic device with an appropriate bend in the lumen of the support device that bends at the bend or bifurcation of the biological lumen. As a result, the medical device suppresses the occurrence of excessive bending and friction of the therapeutic device.

The plurality of grooves may be arranged so as to face each other in a plane orthogonal to the long axis of the tubular body. Thereby, the tubular body can be easily bent in at least two directions in which the groove is located, and the minimum bending radius can be defined.

The plurality of grooves are arranged in the long axis direction of the tubular body, and the grooves adjacent to each other in the long axis direction may be arranged with a phase shift of 90 ° in the circumferential direction. This makes it easier for the tubular body to bend in all directions in the circumferential direction, and at the same time, it can flexibly bend while defining the minimum bending radius in four directions at 90 ° intervals in the circumferential direction. Therefore, the medical device has improved insertability and operability at a target position.

The groove may not penetrate the wall portion of the tubular body. As a result, the inner peripheral surface of the tubular body has a continuous surface without grooves from the tip opening to the proximal opening. Therefore, the therapeutic device passing through the lumen of the tubular body can be operated smoothly without being caught in the groove. Therefore, the operability of this medical device is improved. In addition, the medical device can define a minimum bending radius while maintaining a rigid structure by a continuous wall portion left as the inner peripheral surface of the tubular body.

The shaft has a wide portion at the tip portion, and the wide portion may be connected to the tubular body. As a result, the contact area between the shaft and the tubular body is increased, so that the shaft and the tubular body can be firmly fixed. Therefore, the medical device can easily transmit the force acting on the base end portion of the shaft to the tubular body, and the operability is improved. The medical device can also prevent the shaft from detaching from the tubular body.

The tubular body has an outer connecting hole formed by being recessed on the outer peripheral surface and an inner connecting hole formed by being recessed on the inner peripheral surface, and the wide portion is an outer side arranged in the outer connecting hole. It may have a wide portion and an inner wide portion arranged in the inner connecting hole. As a result, the contact area between the shaft and the tubular body is further increased, so that the shaft and the tubular body can be firmly fixed. Further, since the outer wide portion is arranged in the outer connecting hole, it is difficult to project from the outer peripheral surface of the tubular body. Therefore, the tubular body can smoothly move in the lumen of the support device and can suppress damage to the support device. Further, since the inner wide portion is arranged in the inner connecting hole, it is difficult to project from the inner peripheral surface of the tubular body. Therefore, the treatment device can smoothly move through the lumen of the tubular body and can suppress damage to the treatment device.

It is a schematic diagram which shows the medical device inserted in the living body. It is a schematic diagram which shows the medical device inserted in the living body in an enlarged manner. It is a top view which shows the medical device which concerns on embodiment. It is a figure which shows the medical device which concerns on embodiment, (A) is the sectional view along the line AA of FIG. 3, (B) is the sectional view which follows the line BB of FIG. 3, (C) is FIG. FIG. 1C is a cross-sectional view taken along the line CC, and FIG. 3D is a cross-sectional view taken along the line DD of FIG. It is sectional drawing which shows the medical device, (A) shows this embodiment, (B) shows the 1st modification, (C) shows the 2nd modification. It is a top view which shows the modification of the medical device, (A) shows the 3rd modification, (B) shows the 4th modification. It is sectional drawing which shows the modification of the medical device, (A) shows the 5th modification, (B) shows the 6th modification, and (C) shows the 7th modification. It is a top view which shows the state which the tubular body was bent. It is a schematic diagram which shows the medical device inserted in the living body in an enlarged manner.

Hereinafter, embodiments of the present invention will be described with reference to the drawings. The dimensions of the drawings may be exaggerated and differ from the actual dimensions for convenience of explanation. Further, in the present specification and the drawings, components having substantially the same functional configuration are designated by the same reference numerals, so that duplicate description will be omitted. In the present specification, the side of the medical device to be inserted into the living lumen is referred to as the "tip side", and the hand side to be operated is referred to as the "base end side".

As shown in FIGS. 1 and 2, the medical device 10 according to the present embodiment is used for interventional treatment in the common bile duct 101. Specifically, the medical device 10 is a support catheter 80 (support) inserted into the common bile duct 101 from an endoscope 70 introduced from the mouth through the duodenum 100 to the vicinity of the entrance branch 102 of the common bile duct 101. Used in the lumen of the device). The support catheter 80 supports a therapeutic device 90 such as a catheter or guide wire for the treatment of the common bile duct 101. The medical device 10 prevents the treatment device 90 from being excessively bent or excessively rubbed in the lumen of the support catheter 80.

As shown in FIGS. 3 to 5 (A), the medical device 10 includes a long shaft 20, a tubular body 30 fixed to the tip of the shaft 20, and a covering layer 50.

As shown in FIG. 3, the shaft 20 includes a long shaft body 21 and a shaft connecting portion 22 arranged at the tip of the shaft body 21. The shaft body 21 has a constant cross-sectional shape and extends from the base end to the tip end. The cross-sectional shape of the shaft body 21 is preferably circular, for example, but is not limited to this, and may be elliptical, quadrangular, or the like. The outer diameter of the shaft body 21 (when the cross section is not circular, the thickness of the thickest portion in the cross section) is not particularly limited, and is, for example, 0.1 to 0.4 mm.

As shown in FIGS. 3 and 4A, the shaft connecting portion 22 is a portion connected to the tubular body 30. The shaft connecting portion 22 includes a wide portion 22A formed to be wider than the outer diameter of the shaft main body 21. The wide portion 22A includes an outer wide portion 23 and an inner wide portion 24. The outer wide portion 23 and the inner wide portion 24 are formed to be wider than the outer diameter of the shaft main body 21. The shaft connecting portion 22 is connected to the base end portion of the tubular body 30. Therefore, the shaft connecting portion 22 hardly hinders the bending of the tubular body 30. Therefore, the tubular body 30 can maintain flexibility.

The outer wide portion 23 is arranged in the outer connecting hole 31 formed by being recessed in the outer peripheral surface of the tubular body 30 on the proximal end side. Therefore, the outer wide portion 23 does not protrude from the outer peripheral surface of the tubular body 30. The outer wide portion 23 is in contact with the bottom surface (the surface located in the depth direction) of the outer connection hole 31 of the tubular body 30 on its wide surface, and is connected to the tubular body 30 by welding, brazing, adhesive, or the like. To. The inner wide portion 24 is arranged in the inner connecting hole 32 formed by being recessed in the inner peripheral surface on the proximal end side of the tubular body 30. Therefore, the inner wide portion 24 does not protrude from the inner peripheral surface of the tubular body 30. The inner wide portion 24 comes into contact with the bottom surface of the inner connecting hole 32 of the tubular body 30 on its wide surface, and is connected to the tubular body 30 by welding, brazing, adhesive, or the like. The thickness of the outer wide portion 23 and the inner wide portion 24 is not particularly limited, but is, for example, 0.15 mm.

The outer wide portion 23 and the inner wide portion 24 are connected to the tubular body 30 over a large area. Further, the outer wide portion 23 and the inner wide portion 24 sandwich the wall portion 35 of the tubular body 30. Therefore, the shaft 20 is firmly fixed to the tubular body 30 at the shaft connecting portion 22. Therefore, the shaft 20 can satisfactorily transmit the force in the long axis direction X acting on the proximal end portion and the rotational force around the long axis to the tubular body 30. Further, since the shaft 20 is firmly fixed to the tubular body 30, it is possible to prevent the shaft 20 from being separated from the tubular body 30. The shapes of the outer wide portion 23 and the inner wide portion 24 are not particularly limited as long as they are wider than the outer diameter of the shaft body 21.

As the constituent material of the shaft 20, for example, a metal material such as nickel-titanium alloy, stainless steel, piano wire, cobalt alloy, superelastic alloy, and a resin material such as polyetheretherketone (PEEK) can be preferably applied. Considering connecting the shaft 20 and the tubular body 30, it is preferable that both the shaft 20 and the tubular body 30 are made of a metal material.

The shaft 20 may have only one of the outer wide portion 23 or the inner wide portion 24. Further, the shaft 20 does not have to have the outer wide portion 23 and the inner wide portion 24 formed as in the third modification shown in FIG. 6 (A). Further, as in the fourth modification shown in FIG. 6B, the shaft 20 may be connected in a range from the tip end portion to the base end portion of the tubular body 30. As a result, the contact area between the shaft 20 and the tubular body 30 is increased. Therefore, the shaft 20 can satisfactorily transmit the force in the long axis direction X acting on the proximal end portion and the rotational force around the long axis to the tubular body 30. Further, it is possible to prevent the shaft 20 from being separated from the tubular body 30. It is desirable that the shaft 20 does not protrude toward the tip of the tubular body 30.

Further, the shaft 20 may project and be fixed to the outer peripheral surface of the tubular body 30 as in the fifth modification shown in FIG. 7A. That is, the tubular body 30 does not have to form the outer connecting hole 31 and the inner connecting hole 32. With such a structure, manufacturing is easy. Further, the shaft 20 may be fixed to the inner peripheral surface of the tubular body 30. Further, the shaft 20 may be fixed by inserting the tip end portion into the substantially cylindrical wall portion 35 of the tubular body 30, as in the sixth modification shown in FIG. 7B. Further, as in the seventh modification shown in FIG. 7C, the tip portion of the shaft 20 having a non-circular (for example, quadrangular) cross-sectional shape is inserted into and fixed to the wall portion 35 of the tubular body 30. May be good. As a result, the shaft 20 can satisfactorily transmit the force acting on the proximal end portion in the long axis direction X and the rotational force around the long axis to the tubular body 30.

As shown in FIGS. 3, 4, and 5 (A), the tubular body 30 has a tip opening 33, a proximal opening 34, and a substantially cylindrical wall portion 35. The wall portion 35 is formed with a lumen 36 penetrating from the tip opening 33 to the proximal opening 34. A plurality of grooves extending in the circumferential direction Y are formed on the outer peripheral surface of the tubular body 30. The tubular body 30 includes 6 pairs of the first groove group 37 and 6 pairs of the second groove group 38. The first groove group 37 and the second groove group 38 are arranged alternately in the long axis direction X of the tubular body 30 at regular intervals. An annular link portion 39 in which no groove is formed is formed between the first groove group 37 and the second groove group 38.

Each of the first groove groups 37 includes a first groove 41 and a second groove 42 extending in the circumferential direction Y of the tubular body 30. The first groove 41 and the second groove 42 are formed in the same shape at opposite positions in the circumferential direction Y of the tubular body 30. The angle at which each of the first groove 41 and the second groove 42 extends in the circumferential direction Y is preferably less than 180 °, more preferably 120 to 179 °, still more preferably 170 to 179 °. .. A first pillar portion 45 is formed at a position sandwiched between the first groove 41 and the second groove 42 in the circumferential direction Y of the tubular body 30. The first groove 41 and the second groove 42 impart flexibility to the tubular body 30, and the first pillar portion 45 imparts rigidity (shape stability) to the tubular body 30. The depths of the first groove 41 and the second groove 42 are preferably, but not limited to, constant in the circumferential direction Y. The depth of the groove is the length in the radial direction from the outer peripheral surface of the cylindrical shape in the state where the groove is not formed to the central axis. The radial direction is a direction along the radius of the tubular body 30, and coincides with the radial direction centered on the axial center on the plane orthogonal to the axial center of the tubular body 30. The first groove 41 and the second groove 42 are evenly arranged in the circumferential direction Y. Therefore, the tubular body 30 can reduce the anisotropy of bending.

Each of the second groove groups 38 includes a third groove 43 and a fourth groove 44 extending in the circumferential direction Y of the tubular body 30. The third groove 43 and the fourth groove 44 are formed in the same shape at opposite positions in the circumferential direction Y of the tubular body 30. The third groove 43 and the fourth groove 44 have the same shape as the first groove 41 and the second groove 42. The third groove 43 and the fourth groove 44 are formed with a phase shift of 90 ° with respect to the first groove 41 and the second groove 42. The angle at which each of the third groove 43 and the fourth groove 44 extends in the circumferential direction Y of the tubular body 30 is preferably less than 180 °, more preferably 120 to 179 °, still more preferably 170 to 170 °. It is 179 °. A second pillar portion 46 is formed at a position sandwiched between the third groove 43 and the fourth groove 44 in the circumferential direction Y of the tubular body 30. The third groove 43 and the fourth groove 44 impart flexibility to the tubular body 30, and the second column portion 46 imparts rigidity (shape stability) to the tubular body 30. The depths of the third groove 43 and the fourth groove 44 are preferably, but not limited to, constant in the circumferential direction Y. The third groove 43 and the fourth groove 44 are evenly arranged in the circumferential direction Y. Therefore, the tubular body 30 can reduce the anisotropy of bending.

The number of grooves extending in the circumferential direction Y of the tubular body 30 arranged in each of the first groove group 37 and the second groove group 38 is two in the present embodiment, but may be one. It may be 3 or more. However, in order to improve the bending of the tubular body 30, it is preferable to have two or more grooves in the circumferential direction Y on the plane orthogonal to the long axis of the tubular body 30. Further, the medical device 10 may have only one of the first groove group 37 and the second groove group 38. Further, the groove may be formed all around the outer peripheral surface of the tubular body 30 over 360 °. In this case, the first pillar portion 45 and the second pillar portion 46 are not formed. If the grooves are formed over 360 °, the tubular body 30 will have increased flexibility.

The length of the first groove 41 and the second groove 42 in the circumferential direction Y is preferably longer than the length of the first pillar portion 45 in the circumferential direction Y. Further, the length of the third groove 43 and the fourth groove 44 in the circumferential direction Y is preferably longer than the length of the second pillar portion 46 in the circumferential direction Y. This makes the tubular body 30 flexible and easy to bend.

The first groove 41 has a groove depth T and a groove width L in the semimajor direction X. Further, the distance between the first grooves 41 adjacent to each other in the semi-major axis direction X is defined as the separation distance D, and the number of the first grooves 41 is defined as N. N is an integer, and in this embodiment N = 6. The same applies to the second groove 42, the third groove 43, and the fourth groove 44. As shown in FIG. 8, if the tubular body 30 is bent so that the side where the first grooves 41 are formed side by side is on the inside, the adjacent groove edge portions 41A of the first groove 41 come into contact with each other. At this time, the adjacent groove edge portions 42A of the second groove 42 are separated from each other. The groove edge portion is the edge of the groove opening formed on the outer peripheral surface of the tubular body 30. It is difficult for a force that brings the adjacent groove edges closer to each other or keeps them away from each other to act on the third groove 43 and the fourth groove 44. Therefore, the shapes of the third groove 43 and the fourth groove 44 hardly change. The angle formed by the two link portions 39 sandwiching the first groove 41 is defined as the inclination angle β. The distance from the bending center O of the tubular body 30 to the groove edge portion 41A in a state where the adjacent groove edge portions 41A are in contact with each other is defined as the minimum bending radius R. At this time, approximately the following equation (1) holds.
R: D = T: L ... Equation (1)

Therefore, the minimum bending radius R is approximately calculated by the following equation (2).
R = D ・ T / L ... Equation (2)

Further, approximately, the following equation (3) holds.
L / 2 = T · sin (β / 2)… Equation (3)

Therefore, the inclination angle β due to the contact between the outer edges of the first groove 41 is approximately calculated by the following equation (4).
β = 2 · sin ^-1 (L / (2 · T)) Equation (4)

Therefore, the total bending angle θ of the tubular body 30 having N first grooves 41 is approximately calculated by the following equation (5). The total bending angle θ is the angle formed by the tip end portion and the base end portion of the tubular body 30.
θ = 2 ・ N ・ sin ^-1 (L / (2 ・ T))… Equation (5)

From the above equation, the shape and number of grooves can be set so as to have a desired minimum bending radius R and total bending angle θ. The minimum bending radius R and the total bending angle θ can also be measured by grasping and bending both ends of the tubular body 30 in the semimajor direction X.

It is preferable that the constituent material of the tubular body 30 has high rigidity but low ductility so that the minimum bending radius R can be defined while flexibly bending. Further, it is desirable that the constituent material of the tubular body 30 is easy to form this structure and has elasticity necessary for bending. As the constituent material of the tubular body 30, a metal material, a resin material, or a combination thereof can be preferably applied. Metallic materials include, for example, nickel-titanium alloys, stainless steels, mild steels, nickel-chromium alloys, nickel-chromium iron alloys, cobalt alloys, tungsten or tungsten alloys, or other suitable materials. The resin material is not particularly limited, but for example, polyetheretherketone (PEEK), polyethylene (PE) and the like can be preferably used. The tubular body 30 is manufactured by, for example, laser processing, electric discharge machining, etching processing, cutting processing, or the like.

The constituent material of the tubular body 30 may include an X-ray opaque material such as gold, platinum, or tungsten so that the tubular body 30 has X-ray contrast property. As a result, the tubular body 30 has improved visibility under fluoroscopy. The tubular body 30 may contain an X-ray opaque material throughout the tubular body 30. Alternatively, the tubular body 30 may contain an X-ray permeable material only at both ends of the tubular body 30 in the semimajor direction X. In these cases, the operator can grasp the total length or the positions of both ends of the tubular body 30 in the body. Further, the tubular body 30 may contain an X-ray opaque material only in the central portion of the tubular body 30 in the long axis direction X. In this case, the operator can grasp the center of the bending tubular body 30. These allow the operator to easily place the tubular body 30 at the entrance branch 102.

The total length of the medical device 10 in the semimajor direction X is not particularly limited, but is, for example, 800 to 1200 mm.

The tubular body 30 has a cylindrical shape in which a first groove 41, a second groove 42, a third groove 43, and a fourth groove 44 are formed, as in the first modification shown in FIG. 5 (B). It may be formed by the first member 61 and the second member 62 which is a cylinder fitted to the inner peripheral surface of the first member 61. The first groove 41, the second groove 42, the third groove 43, and the fourth groove 44 of the first member 61 penetrate the wall portion of the first member 61. The first member 61 and the second member 62 are fixed to the inner peripheral surface of the first member 61 by crimping, bonding, welding or the like. With such a configuration, it becomes easy to process the groove of the tubular body 30. The constituent materials of the first member 61 and the second member 62 may be common or different. As an example, the first member 61 may be formed of a highly rigid metal material, and the second member 62 may be formed of a flexible resin material. As a result, the tubular body 30 can be flexibly bent by being provided with the second member 62, and the minimum bending radius R can be defined by being provided with the first member 61.

Further, in the tubular body 30, as in the second modification shown in FIG. 5C, the first groove 41, the second groove 42, the third groove 43 and the fourth groove 44 are the tubular body 30. It may penetrate to the inner peripheral surface of the. As a result, the tubular body 30 can obtain high flexibility.

The coating layer 50 is formed of a low friction material that reduces friction. The low friction layer is preferably formed on both the outer peripheral surface and the inner peripheral surface of the tubular body 30. The coating layer 50 may be provided only on one surface of the outer peripheral surface or the inner peripheral surface of the tubular body 30. The coating layer 50 may not be provided.

The low friction material is, for example, a hydrophilic polymer. The hydrophilic polymer is a cellulose-based polymer substance, a polyethylene oxide-based polymer substance, a maleic anhydride-based polymer substance (for example, a maleic anhydride copolymer such as a methyl vinyl ether-maleic anhydride copolymer), or an acrylamide-based polymer. Examples thereof include high molecular weight substances (for example, block copolymers of polyacrylamide and glycidyl methacrylate-dimethylacrylamide), water-soluble nylon, polyvinyl alcohol, polyvinylpyrrolidone, and derivatives thereof. The hydrophilic polymer forms a strong water-fixed layer on its surface, exhibits high affinity for blood in blood vessels and blood vessel walls, and exhibits low friction (low coefficient of friction). Alternatively, the low friction material may be a fluorine-based resin such as polytetrafluoroethylene (PTFE) or a silicone-based resin.

Next, how to use the medical device 10 will be described.

The medical device 10 is used for interventional treatment within the common bile duct 101. To this end, the surgeon introduces the endoscope 70 from the duodenum 100 to the vicinity of the entrance bifurcation 102, as shown in FIG. The operator then projects the support catheter 80 out of the endoscope 70 and inserts it into the entrance branch 102 of the common bile duct 101. As a result, the support catheter 80 bends in the vicinity of the entrance branch 102 and enters the common bile duct 101. Next, the surgeon inserts the therapeutic device 90 from the proximal opening 34 of the tubular body 30 of the medical device 10 into the distal opening 33. The surgeon then inserts the treatment device 90 into the lumen of the support catheter 80. Subsequently, the surgeon operates the shaft 20 of the medical device 10 to place the tubular body 30 at the bent portion of the support catheter 80, as shown in FIGS. 1 and 2. At this time, the operator can move or rotate the tubular body 30 in the semimajor axis direction X by operating the base end portion of the shaft 20 under fluoroscopy. The tubular body 30 can be bent in any direction, and for example, as shown in FIG. 8, the tubular body 30 can be bent so that the groove edge portions 41A of the first groove 41 come into contact with each other. The tubular body 30 can flexibly bend until the groove edges 41A of the first groove 41 arranged inside the bend come into contact with each other. Therefore, the operator can smoothly insert the tubular body 30 through the lumen of the support catheter 80 to the vicinity of the entrance branch 102. In the vicinity of the inlet branch 102, the tubular body 30 bends following the flexion of the support catheter 80. When the groove edges 41A of the first groove 41 arranged inside the bend of the tubular body 30 come into contact with each other, the tubular body 30 is restricted from further bending. That is, the tubular body 30 is restricted from bending at a predetermined total bending angle θ or more, and the minimum bending radius R is defined. As a result, the therapeutic device 90 passing through the lumen of the tubular body 30 is restricted from being bent by the tubular body 30 to a predetermined total bending angle θ or more. As a result, the treatment device 90 suppresses the occurrence of excessive bending and friction in the lumen of the support device when the operator inserts the treatment device 90 into the common bile duct, and the operability is improved. After the procedure with the treatment device 90 is completed, the operator can remove the medical device 10 together with the treatment device 90. Therefore, the operation of removing the medical device 10 does not burden the operator.

The minimum bending radius R is preferably 2 to 12 mm, more preferably 4 to 10 mm. As a result, the medical device 10 can support the therapeutic device 90 with an appropriate bend in the lumen of the support catheter 80 that bends at the bent portion or the bifurcated portion (for example, the inlet bifurcation 102) of the biological lumen. As a result, the medical device 10 suppresses the occurrence of excessive bending and friction of the therapeutic device 90.

The total bending angle θ is not particularly limited, but is preferably 150 ° or less. Since the angle of the entrance branch 102 between the duodenum 100 and the common bile duct 101 is about 150 °, the total bending angle θ preferably does not exceed 150 °. Also, it is not desirable for the tubular body 30 to bend excessively in one first groove 41. Therefore, the inclination angle β is preferably 45 ° or less. As an example, since the total bending angle θ is 150 °, the number N of the first grooves 41 is preferably 6 or less, assuming that the inclination angle β is 25 °.

If the length of the tubular body 30 is too short, the length of the therapeutic device 90 that can be supported by the tubular body 30 will be short. In this case, the therapeutic device 90 is not supported by the tubular body 30 and may be excessively bent on the proximal end side and the distal end side of the tubular body 30. Therefore, it is preferable that the tubular body 30 is formed with an appropriate length in the semimajor direction X. The tubular body 30 is formed to have an appropriate length in the semimajor direction X, so that the therapeutic device 90 can be gently bent to a required angle. Therefore, by adjusting the length of the tubular body 30, the therapeutic device 90 suppresses excessive bending even on the proximal end side and the distal end side of the tubular body 30.

As shown in FIG. 1, it is preferable that the tip end portion of the tubular body 30 is arranged at a substantially straight line portion of the common bile duct 101, and the proximal end portion of the tubular body 30 is arranged at a substantially straight line portion of the endoscope 70. .. The inner diameter P1 of the duodenum 100 is about 30 to 40 mm. The length P3 from the entrance branch 102 to the gallbladder is about 100 to 150 mm. The inner diameter P2 of the common bile duct 101 is about 5 to 10 mm. There are few bent portions in the lumen of the common bile duct 101 and the lumen of the endoscope 70. In order to stabilize the tubular body 30 on the lumen side of the endoscope 70 located in the duodenum 100, the length of the tubular body 30 in the semimajor direction X is about 1 to 2 times the inner diameter P1 of the duodenum 100. desirable. Therefore, the length of the tubular body 30 in the semimajor direction X is not particularly limited, but is preferably 30 to 80 mm. Further, the outer diameter of the tubular body 30 is preferably 10 mm or less, which is the inner diameter P2 of the common bile duct 101.

Further, if the inner diameter of the tubular body 30 is too large with respect to the outer diameter of the therapeutic device 90, the therapeutic device 90 will be excessively bent in the lumen of the tubular body 30. Therefore, the tubular body 30 cannot effectively suppress the occurrence of excessive bending and friction of the therapeutic device 90. Therefore, the tubular body 30 is preferably formed with an inner diameter suitable for the outer diameter of the therapeutic device 90. Sliding between coaxial tubular devices is possible when the clearance is 0.5 mm or more. Therefore, it is desirable that the inner diameter of the tubular body 30 is 0.5 mm or more larger than the outer diameter of the treatment device 90. The outer diameter of a typical therapeutic device 90 is 0.4-5.0 mm. Therefore, the inner diameter of the tubular body 30 is preferably 0.9 to 5.5 mm.

Further, the tubular body 30 needs to be flexibly bent when moving in the support catheter 80 or when being arranged near the entrance branch 120. Therefore, the thickness of the wall portion 35 of the tubular body 30 is preferably smaller than the inner diameter of the tubular body 30. The thickness of the wall portion 35 of the tubular body 30 is not particularly limited, but is, for example, 0.05 to 0.9 mm.

As an example, as shown in FIG. 5B, the tubular body 30 is formed of a first member 61 and a second member 62, the first member 61 is made of a nickel-titanium alloy, and the second member 62 is Made of polyethylene. As shown in FIG. 3, in the tubular body 30, six first groove groups 37 and six second groove groups 38 are arranged alternately and at equal intervals in the semimajor direction X, and the first groove group 37 is circumferential. It is formed by two grooves (first groove 41 and second groove 42) that are evenly arranged with an interval of 1.0 mm in the direction, and the second groove group 38 is spaced by 1.0 mm in the circumferential direction. It is formed by two evenly aligned grooves (third groove 43 and fourth groove 44). The tilt angle β is 25 °. The inner diameter of the tubular body 30 is 3.0 mm, the thickness is 0.5 mm, the outer diameter is 4.0 mm, and the length in the semimajor direction X is 60 mm. The shape of each groove (first groove 41, third groove 43, second groove 42 or fourth groove 44) is common, the length of the groove in the semimajor direction X is 0.2 mm, and the groove depth is The width is 0.4 mm, the width of the grooves in the circumferential direction is approximately 180 ° (however, less than 180 °), and the distance between the grooves arranged in the semimajor direction X is 2.8 mm. The shaft 20 is made of a nickel-titanium alloy. The diameter of the shaft body 21 is 0.6 mm, and the thickness of the shaft connecting portion 22 is 0.15 mm.

Further, in the tubular body 30, not only when the first groove 41 is arranged inside the bend, but also when the second groove 42, the third groove 43 or the fourth groove 44 is arranged inside the bend, the tubular body 30 is arranged inside the bend. The same effect can be obtained. The first groove group 37 and the second groove group 38 are arranged with a phase shift. Therefore, the medical device 10 can suppress the occurrence of excessive bending and friction of the therapeutic device 90 regardless of the bending direction at the time of placement. It should be noted that the medical device 10 is sufficient even if the first groove 41, the second groove 42, the third groove 43 or the fourth groove 44 do not exactly match the inside of the bend at the time of arrangement. It can be effective.

The first groove 41, the second groove 42, the third groove 43, and the fourth groove 44 are open outward in the radial direction of the tubular body 30. The radial outer direction is a direction away from the axial center of the tubular body 30 in the radial direction along the radius of the tubular body 30. Therefore, in each groove, when the tubular body 30 is bent, the groove edges come into contact with each other, so that the minimum bending radius R can be easily defined.

As described above, the medical device 10 according to the present embodiment is a medical device 10 in which a lumen 36 through which a long treatment device 90 can be inserted is formed, and is a shaft 20 having a tip end portion and a proximal end portion. A tubular body 30 provided with a tip opening 33, a proximal opening 34, and a wall portion 35 extending between the distal opening 33 and the proximal opening 34 to form a lumen 36, and fixed to the distal end of the shaft 20. The wall portion 35 is formed with a first groove 41, a second groove 42, a third groove 43, and a fourth groove 44 extending in the circumferential direction Y on the outer peripheral surface of the tubular body 30.

The medical device 10 configured as described above can flexibly bend following the support catheter 80 by the groove formed on the outer peripheral surface of the lumen body 30. When the tubular body 30 is bent until the groove edge portions (for example, the groove edge portions 41A of the first groove 41) adjacent to each other in the semi-major axis direction X come into contact with each other, the bending of a predetermined total bending angle θ or more is restricted. Therefore, the tubular body 30 has a minimum bending radius R defined. As a result, the medical device 10 can suppress the occurrence of excessive bending and friction of the treatment device 90 inserted into the tubular body 30, and can improve the operability of the treatment device 90.

Further, the minimum bending radius R of the tubular body 30, which is the distance from the bending center O of the tubular body 30 to the groove edge portion 41A in a state where the groove edge portions 41A adjacent to each other in the semimajor axis direction X are in contact with each other, is 2 to 2. It is 12 mm. Thereby, the medical device 10 can support the therapeutic device 90 with an appropriate bend in the lumen of the support catheter 80 that bends at the bent portion or the bifurcated portion of the biological lumen. As a result, the medical device 10 suppresses the occurrence of excessive bending and friction of the therapeutic device 90.

Further, the first groove 41 and the second groove 42 are arranged so as to face each other in a plane orthogonal to the long axis of the tubular body 30. Further, the third groove 43 and the fourth groove 44 are arranged so as to face each other in a plane orthogonal to the long axis of the tubular body 30. As a result, the tubular body 30 can easily bend at least in the direction in which the groove is located, and the minimum bending radius R can be defined.

Further, the plurality of grooves are arranged in the long axis direction X of the tubular body 30, and the grooves adjacent to the long axis direction X are arranged with a phase shift of 90 ° in the circumferential direction Y. As a result, the tubular body 30 can be easily bent in all directions in the circumferential direction Y, and at the same time, can be flexibly bent while defining the minimum bending radius R in four directions at 90 ° intervals in the circumferential direction Y. Therefore, the medical device 10 has improved insertability and operability at a target position.

Further, the groove does not penetrate the wall portion 35 of the tubular body 30. As a result, the inner peripheral surface of the tubular body 30 has a continuous surface without grooves from the tip opening 33 to the proximal opening 34. Therefore, the treatment device 90 passing through the lumen of the tubular body 30 can be smoothly operated without being caught in the groove. Further, the medical device 10 can define the minimum bending radius R while maintaining a rigid structure by the continuous wall portion 35 left as the inner peripheral surface of the tubular body 30.

Further, the shaft 20 has a wide portion 22A at the tip end portion, and the wide portion 22A is connected to the tubular body 30. As a result, the contact area between the shaft 20 and the tubular body 30 becomes large, so that the shaft 20 and the tubular body 30 can be firmly fixed. Therefore, the medical device 10 can easily transmit the force acting on the base end portion of the shaft 20 to the tubular body 30, and the operability is improved. In addition, the medical device 10 can suppress the shaft 20 from coming off from the tubular body 30.

Further, the tubular body 30 has an outer connecting hole 31 formed by being recessed on the outer peripheral surface and an inner connecting hole 32 formed by being recessed on the inner peripheral surface, and the wide portion 22A is formed in the outer connecting hole 31. It has an outer wide portion 23 arranged and an inner wide portion 24 arranged in the inner connecting hole 32. As a result, the contact area between the shaft 20 and the tubular body 30 is further increased, so that the shaft 20 and the tubular body 30 can be firmly fixed. Further, since the outer wide portion 23 is arranged in the outer connecting hole 31, it is difficult to project from the outer peripheral surface of the tubular body 30. Therefore, the tubular body 30 can smoothly move in the lumen of the support catheter 80 and can suppress damage to the support catheter 80. Further, since the inner wide portion 24 is arranged in the inner connecting hole 32, it is difficult to project from the inner peripheral surface of the tubular body 30. Therefore, the treatment device 90 can smoothly move in the lumen of the tubular body 30 and can suppress damage to the treatment device 90.

The present invention is not limited to the above-described embodiment, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the biological lumen into which the medical device 10 is inserted is not limited to the common bile duct 101, and may be, for example, a pancreatic duct, a blood vessel, a bronchi, or the like. In particular, the medical device 10 exerts its effect at the bent portion and the bifurcated portion of the biological lumen.

Further, although the groove extends in the circumferential direction Y of the tubular body 30, it may be formed so as to be inclined to some extent with respect to the circumferential direction Y. That is, it may be formed so as to be inclined to some extent with respect to a plane orthogonal to the long axis of the tubular body 30. Alternatively, the grooves may be formed in a spiral shape.

Further, the medical device 10 exerts the above-mentioned remarkable effect by arranging it in the lumen of the support device such as the support catheter 80, but it does not necessarily have to be arranged in the lumen of the support device and used. Good. The medical device 10 can exert a remarkable effect without being placed in the lumen of the support device.

10 Medical device 20 Shaft 22A Wide part 23 Outer wide part 24 Inner wide part 33 Tip opening 34 Base end opening 30 Tubular body 35 Wall 36 Cavity 41 1st groove 42 2nd groove 43 3rd groove 44 4th Groove 80 Support Catheter 90 Treatment Device (Other Devices)
100 Duodenum 101 Common bile duct 102 Entrance branch X Semi-major axis Y Circumferential direction

Claims (7)

A medical device with a lumen through which other long devices can be inserted.
A shaft with a tip and a base,
It has a tip opening, a proximal opening, and a tubular body fixed to the distal end of the shaft, comprising a wall portion extending between the distal opening and the proximal opening to form a lumen.
A medical device, wherein the wall portion is formed with at least one groove extending in the circumferential direction on an outer peripheral surface of the tubular body. The minimum bending radius, which is the distance from the bending center of the tubular body to the groove edge portion in a state where the groove edges of the grooves adjacent to each other in the long axis direction of the tubular body are in contact with each other, is 2 to 12 mm. The medical device according to claim 1, wherein the medical device is characterized in that. The medical device according to claim 1 or 2, wherein the plurality of grooves are arranged so as to face each other in a plane orthogonal to the long axis of the tubular body. The plurality of grooves are arranged in the semi-major axis direction of the tubular body.
The medical device according to any one of claims 1 to 3, wherein the grooves adjacent to each other in the long axis direction are arranged with a phase shift of 90 ° in the circumferential direction. The medical device according to any one of claims 1 to 4, wherein the groove does not penetrate the wall portion of the tubular body. The medical device according to any one of claims 1 to 5, wherein the shaft has a wide portion at a tip end, and the wide portion is connected to the tubular body. The tubular body has an outer connecting hole formed by being recessed on the outer peripheral surface and an inner connecting hole formed by being recessed on the inner peripheral surface.
The medical device according to claim 6, wherein the wide portion has an outer wide portion arranged in the outer connecting hole and an inner wide portion arranged in the inner connecting hole.

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