WO2011148479A1 - Tige médicale et instrument médical - Google Patents

Tige médicale et instrument médical Download PDF

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Publication number
WO2011148479A1
WO2011148479A1 PCT/JP2010/058937 JP2010058937W WO2011148479A1 WO 2011148479 A1 WO2011148479 A1 WO 2011148479A1 JP 2010058937 W JP2010058937 W JP 2010058937W WO 2011148479 A1 WO2011148479 A1 WO 2011148479A1
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WO
WIPO (PCT)
Prior art keywords
shaft
tubular base
rigidity
distal end
medical
Prior art date
Application number
PCT/JP2010/058937
Other languages
English (en)
Japanese (ja)
Inventor
慶一 鏡味
達道 藤原
Original Assignee
株式会社グッドマン
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by 株式会社グッドマン filed Critical 株式会社グッドマン
Priority to JP2012517048A priority Critical patent/JP5486679B2/ja
Priority to PCT/JP2010/058937 priority patent/WO2011148479A1/fr
Publication of WO2011148479A1 publication Critical patent/WO2011148479A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0009—Making of catheters or other medical or surgical tubes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M2025/0004—Catheters; Hollow probes having two or more concentrically arranged tubes for forming a concentric catheter system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0059—Catheters; Hollow probes characterised by structural features having means for preventing the catheter, sheath or lumens from collapsing due to outer forces, e.g. compressing forces, or caused by twisting or kinking
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • A61M2025/0063—Catheters; Hollow probes characterised by structural features having means, e.g. stylets, mandrils, rods or wires to reinforce or adjust temporarily the stiffness, column strength or pushability of catheters which are already inserted into the human body
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0175—Introducing, guiding, advancing, emplacing or holding catheters having telescopic features, interengaging nestable members movable in relations to one another

Definitions

  • the present invention relates to a medical shaft constituting a part of a medical instrument such as a catheter used by being inserted into a living body, and a medical instrument provided with the medical shaft.
  • balloon catheters have been used in treatments such as PTCA (percutaneous coronary angioplasty).
  • PTCA percutaneous coronary angioplasty
  • a general balloon catheter is provided with a balloon that can be inflated and deflated by adjusting the internal pressure at the distal end of a catheter shaft.
  • the catheter shaft includes an outer shaft and an inner shaft that is inserted through a lumen of the outer shaft, and the inner shaft is installed to extend to the distal end side of the outer shaft.
  • a balloon is provided so that the distal end side and the proximal end side are held with respect to the extended portion of the inner shaft and the distal end portion of the outer shaft, respectively.
  • Compressed fluid that inflates and deflates the balloon is circulated through the lumen of the outer shaft.
  • a guide wire is inserted through the lumen of the inner shaft during insertion into the patient's artery.
  • the performance required for the balloon catheter includes, for example, followability to a bent blood vessel, ability to transmit force when the balloon catheter is inserted into the blood vessel, and kink resistance to force to bend.
  • a distal end shaft formed of a synthetic resin so as to have a relatively low rigidity and a proximal end formed of a metal so as to have a relatively high rigidity is disclosed.
  • Patent Document 1 a spiral slit is formed at a portion of the proximal end side shaft that is inserted into the distal end side shaft, and a boundary portion between the proximal end side shaft and the distal end side shaft is formed.
  • bore of the outer shaft so that it may straddle is disclosed. According to such a configuration, the rigidity of the outer shaft gradually decreases from the proximal end side toward the distal end side, so that followability, transmission performance, and kink resistance can be improved.
  • the core wire is separated from the outer shaft when the catheter is used.
  • the core wire is firmly fixed in order to regulate the separation, there is a concern that a portion where the rigidity is locally increased may be generated at an intermediate position in the axial direction of the catheter. In this case, the operability of the catheter Will fall.
  • the above-mentioned problem is not limited to the balloon catheter, and other medical instruments that include a shaft portion formed by connecting a plurality of shafts arranged in the axial direction and are inserted into the living body when used are also used. It is the same.
  • This invention is made in view of the said situation, and provides the medical instrument provided with the medical shaft which can improve the operativity of the medical instrument which has a shaft part favorably, and the said medical shaft. It is the purpose.
  • the medical shaft according to the first aspect of the invention is used to constitute a shaft portion of a medical instrument that is inserted into a living body when used, and relative to a proximal end side region of another shaft constituting the shaft portion.
  • a medical shaft used by connecting distal ends thereof, a tubular base that is open at least toward the distal side and connected to a proximal end region of the other shaft, and the tubular A rigidity adjusting portion that extends from the base toward the distal end side and is thinner than the tubular base, and that is inserted into the other shaft, and proximal to the distal end of the tubular base
  • a pair of entry holes formed so as to sandwich a continuous portion of the rigidity adjusting portion with the tubular base around the axis, and the pair of entry holes It is characterized in that the distance between them is formed to be wider toward the proximal side.
  • the tubular base and the rigidity adjusting portion are applied when a force in the bending direction is applied to the medical shaft during use of the medical instrument.
  • the load applied to the continuous portion can be well absorbed even in the tubular base.
  • the load absorbing function is provided by the pair of penetration holes formed so as to enter the proximal side from the distal end of the tubular base as described above, and the occurrence of local increase in rigidity is generated. Is suppressed.
  • the pair of entry hole portions are formed so that the distance between them becomes wider toward the proximal side, the rigidity is continuously directed toward the proximal side in the continuous portion of the rigidity adjusting portion. It becomes possible to make it high. As described above, the operability of the medical instrument having the shaft portion can be improved satisfactorily.
  • the medical shaft of the second invention In the medical shaft of the first invention, the rigidity adjusting portion is integrally formed with the tubular base and is far from the peripheral edge of the distal end side opening of the tubular base. It is formed so as to extend toward the distal end side, and the base portion of the rigidity adjusting portion is inserted into the tubular base side by forming the pair of entering hole portions. .
  • the rigidity adjusting portion is integrally formed on the tubular base, it becomes difficult to separate them, and the cost can be reduced and the manufacturing process of the medical shaft can be simplified. Furthermore, since the base portion of the rigidity adjusting portion enters the tubular base side by forming the pair of entry holes, a large load is applied to the boundary portion between the tubular base and the rigidity adjusting portion in the medical shaft. Even if it is applied, the load is suitably received even in the tubular base. Therefore, the possibility that the base portion of the rigidity adjusting portion is damaged is reduced.
  • the medical shaft of the 1st or 2nd invention WHEREIN The said tubular base is provided with the rigidity reduction part for reducing the rigidity of the said tubular base toward the distal end side.
  • the tubular base includes an adjacent region adjacent to the base portion of the rigidity adjusting portion with the pair of entering hole portions therebetween, and the rigidity reducing portion is adjacent to the adjacent portion. It is characterized in that it is formed from the proximal end side of the region to at least the position of the adjacent region.
  • the rigidity-decreasing portion and the stiffness adjusting portion can be made continuous in the axial direction, and compared to the configuration in which the stiffness reducing portion and the stiffness adjusting portion are discontinuous in the axial direction, the distal end side It is possible to make the decrease in the rigidity toward the continuous. Therefore, the kink resistance can be further improved.
  • the rigidity reduction portion is a spiral slit, and the slit is at least in the adjacent region from the proximal end side with respect to the adjacent region. It is formed to the position.
  • the rigidity reduction portion is a spiral slit
  • the distal tip is proximal from the distal end of the tubular base. Need to be separated. In this case, there is a concern that the distal end portion of the tubular base is more rigid than the proximal side.
  • the slit is formed at least up to the position of the adjacent region, and the pair of entry holes are formed on the distal end side of the tubular base rather than the distal tip of the slit, the rigidity is increased. Even with a configuration using a spiral slit as the lowering portion, the rigidity can be favorably reduced toward the distal side.
  • the medical shaft of the fifth invention In the medical shaft of any one of the first to fourth inventions, a through-hole penetrating the tubular base in and out is formed between the pair of entry hole portions. It is characterized by being. According to this configuration, it is possible to continuously reduce the rigidity of the tubular base toward the distal side, including the region where the pair of entry holes are formed.
  • the medical shaft of the sixth aspect of the invention is formed such that the distance between each through hole portion becomes wider toward the proximal side. It is characterized by. According to this configuration, the through hole can be formed while the rigidity is continuously increased toward the proximal side.
  • the medical shaft of the eighth invention In the medical shaft of the seventh invention, the pair of entry holes are formed such that the tip of the entry destination is wider than the entry source side, and The peripheral surface of the tip of the entry destination is formed to have a curved surface. According to this structure, possibility that a crack will generate
  • a medical instrument according to a ninth aspect: the medical shaft according to any one of the first to eighth aspects, wherein the distal end side of the tubular base and the rigidity adjusting portion are inserted into the proximal end side region. And another shaft formed so as to be less rigid than the medical shaft. According to this structure, the medical instrument which has an effect as already demonstrated can be provided.
  • FIG. (A) is a schematic whole side view of the balloon catheter in 1st Embodiment
  • (b) is a side view which expands and shows a part of outer shaft
  • FIG. (A) is a side view of a proximal shaft showing an enlarged continuous portion of the tubular base and the rigidity adjusting portion and its periphery
  • (b) is an enlarged view of the entire rigidity adjusting portion and the distal end of the tubular base.
  • FIG. 2 is an enlarged side view of the proximal shaft showing the entire structure and the distal end of the tubular base
  • FIG. (A)-(c) is a figure for demonstrating the manufacturing method of a proxy shaft.
  • A) is a developed view of the proxy shaft in the second embodiment, and is a developed view showing an enlarged continuous portion of the tubular base and the rigidity adjusting portion
  • (b) is a developed view of the second embodiment.
  • (A)-(c) is an expanded view of the proxy shaft in 3rd Embodiment, Comprising: It is an expanded view which expands and shows the continuous part of a tubular base and a rigidity adjustment part.
  • FIG. 1A is a schematic overall side view of the balloon catheter 10
  • FIG. 1B is an enlarged side view showing a part of the outer shaft 14 constituting the balloon catheter 10, with a broken portion in part. It is a side view including. Note that the region shown in FIG. 1B corresponds to the region A in FIG.
  • a balloon catheter 10 includes a catheter shaft 11 and a hub attached to a proximal end portion of the catheter shaft 11 (a base end portion or an end portion on the insertion source side of the balloon catheter 10). 12 and a balloon 13 attached to the distal end of the catheter shaft 11 (the tip or the end on the insertion destination side of the balloon catheter 10).
  • the catheter shaft 11 includes an outer shaft (outer tube) 14 and an inner shaft (inner tube) 15 inserted in the outer shaft 14. Both the outer shaft 14 and the inner shaft 15 are formed in a tubular shape, and both the shafts 14 and 15 are formed with a lumen penetrating over the entire axial direction (longitudinal direction).
  • the inner shaft 15 is joined to a port portion 16 whose end on the proximal end side is formed at an intermediate position in the axial direction of the outer shaft 14, and a lumen (not shown) of the inner shaft 15 is outside through the port portion 16. Opened to the outside of the shaft 14.
  • the inner shaft 15 is made of a synthetic resin material such as polyamide.
  • the inner shaft 15 is extended to the distal end side with respect to the outer shaft 14, and a tip end body 17 is provided on the distal end portion of the extension region of the inner shaft 15.
  • the balloon 13 has a proximal end side joined to the outer shaft 14 and a distal end side joined to the tip end body 17, and the outer surface of the extension region of the inner shaft 15 is covered. It is provided to cover.
  • the balloon 13 and the tip end body 17 are both made of a synthetic resin material such as polyamide.
  • the balloon 13 has a tubular shape that can be expanded and contracted, and the internal space of the balloon 13 communicates with the inner lumen 14a of the outer shaft 14 (see FIG. 1B).
  • FIG. 1A shows the balloon 13 in a deflated state. If attention is paid to the fact that the compressed fluid flows through the lumen 14a of the outer shaft 14 as described above, the lumen 14a can be referred to as a fluid lumen.
  • the outer shaft 14 includes a distal shaft 21 as a first shaft constituting the distal end side of the outer shaft 14, and is continuous with the distal shaft 21 on the proximal end side and the proximal end of the outer shaft 14.
  • a proxy shaft 22 is provided as a second shaft constituting the side. In this balloon catheter 10, the proxy shaft 22 corresponds to a medical shaft, and the distal shaft 21 corresponds to another shaft.
  • the distal shaft 21 is formed in a tubular shape having a circular cross section (that is, a cross section perpendicular to the axial direction) by a synthetic resin such as polyamide.
  • the inner shaft 15 is inserted with the port portion 16 formed at an intermediate position in the axial direction as an end portion on the proximal end side, and the balloon 13 is joined to the distal end portion.
  • the distal shaft 21 is formed by connecting a plurality of synthetic resin shafts side by side in the axial direction, and among these synthetic resin shafts, the distal end side shaft is more proximal than the proximal end side shaft. Also, the rigidity may be lowered.
  • the proxy shaft 22 is made of stainless steel. However, the present invention is not limited to this, and the proxy shaft 22 may be formed of another metal such as nickel titanium alloy, cobalt, or chromium.
  • the proxy shaft 22 is formed in a tubular shape having a circular cross section.
  • the material, thickness, outer diameter, etc. of the proximal shaft 22 are set so that the rigidity is higher than that of the distal shaft 21.
  • the rigidity means the magnitude of a moment acting when the shaft is bent in a direction perpendicular to the axial direction.
  • the proximal shaft 22 includes a tubular base 23 that constitutes a proximal end side continuing from the hub 12 of the outer shaft 14, and a distal end side within the lumen 21 a of the distal shaft 21 from the distal end portion of the tubular base 23. And a rigidity adjusting portion 24 extending toward the bottom.
  • FIG. 2A is a side view of the proximal shaft 22 showing an enlarged continuous portion of the tubular base 23 and the rigidity adjusting portion 24 and its periphery
  • FIG. 2B is an overall view of the rigidity adjusting portion 24 and the tubular shape. It is a longitudinal cross-sectional view (namely, sectional drawing of the direction along an axial direction) of the proxy shaft 22 which expands and shows the distal end part of the base 23.
  • FIG. FIG. 2C is a longitudinal sectional view of the rigidity adjusting portion 24 enlarged from the distal end portion to the middle position in the axial direction
  • FIG. 2D is the entire rigidity adjusting portion 24 and a tubular base.
  • FIG. 2E is a development view of the proximal shaft 22 and is an expansion view showing an enlarged continuous portion of the tubular base 23 and the rigidity adjusting portion 24.
  • the tubular base 23 has a tubular shape throughout the axial direction, and as shown in FIG. 2A, the end face 23a on the distal end side is formed so as to be orthogonal to the axial direction. That is, the tubular base 23 has a continuous annular cross section in the direction orthogonal to the axial direction over the entire axial direction.
  • the tubular base 23 has a rigidity reduction region 25 formed in a predetermined range on the distal end side.
  • a slit 26 penetrating inward and outward through a wall portion defining the lumen 22a in the proxy shaft 22 is formed in a spiral shape continuously in the axial direction of the proxy shaft 22.
  • the spiral slit 26 is formed so that the pitch becomes narrower continuously or stepwise toward the distal end side.
  • This pitch means a distance between linear portions of the slits 26 arranged in the axial direction when viewed in the state of FIG.
  • the proxy shaft 22 is inserted into the lumen 21 a of the distal shaft 21 so as to be on the same axis as shown in FIG.
  • the entire amount of the rigidity reduction region 25 is inserted into the lumen 21a of the distal shaft 21, and a predetermined range on the proximal end side of the rigidity reduction region 25 is within the lumen. It is set to be inserted into 21a.
  • an overlapping region is formed in which the wall portions 21b and 22b overlap inward and outward in the radial direction so that the interpolated side wall portion 22b of the proxy shaft 22 is on the inside and the coated side wall portion 21b of the distal shaft 21 is on the outside.
  • the insertion side wall portion 22b and the covering side wall portion 21b are joined to each other on the proximal end side from the rigidity reduction region 25 in the overlapping region.
  • the insertion side wall portion 22b and the covering side wall portion 21b are joined by thermally welding the covering side wall portion 21b to the insertion side wall portion 22b.
  • the joining area is continuous around the axis.
  • the rigidity can be set to be relatively low, and the followability can be improved.
  • the proximal shaft 22 constituting the proximal end side of the metal from the metal, the rigidity of the outer shaft 14 decreases from the proximal end side toward the distal end side, and the transmission can be improved.
  • the reduced rigidity region 25 is formed on the distal end side of the proximal shaft 22, the rigidity tends to continuously decrease toward the distal end side in the overlapping region of the shafts 21 and 22. Kink resistance is improved.
  • the rigidity adjusting portion 24 inserted into the lumen 21a of the distal shaft 21 together with the rigidity reduction region 25.
  • the rigidity adjusting portion 24 is formed in a linear or elongated shape so as to extend from the tubular base 23 toward the distal end side, and its length dimension is 85 mm. ing.
  • the present invention is not limited to this, and the length dimension of the rigidity adjusting portion 24 may be in the range of 1 mm to 300 mm.
  • the rigidity adjusting unit 24 is tapered so that the thickness dimension, that is, the radial dimension with respect to the axis of the proxy shaft 22 continuously decreases toward the distal end side. Is formed.
  • the thickness dimension of the root portion that is continuous with the tubular base 23 in the rigidity adjusting portion 24 is the same as or substantially the same as the thickness dimension of the wall portion of the tubular base 23.
  • the thickness of the rigidity adjusting portion 24 is constant from the root portion to the middle position in the longitudinal direction, but the thickness dimension decreases from the middle position toward the end on the distal end side. Is formed.
  • the thickness dimension of the stiffness adjusting portion 24 toward the distal end side is because only one of the outer peripheral surface side and the inner peripheral surface side of the proxy shaft 22 is tapered. It has been realized. Specifically, the inner peripheral surface of the rigidity adjusting portion 24 is formed so as to be flush with the inner peripheral surface of the tubular base 23 at the time of manufacture, and the outer peripheral surface of the rigidity adjusting portion 24 faces the distal end side. It is formed in a tapered shape that gradually enters the inside.
  • the rigidity adjusting portion 24 is formed by tapering the width dimension, that is, the dimension around the axis of the proxy shaft 22. Specifically, in the rigidity adjusting portion 24, the width dimension is formed continuously from the root portion continuous with the tubular base 23 to the distal end portion of the rigidity adjusting portion 24.
  • the rigidity of the rigidity adjusting portion 24 is continuously directed toward the distal end side. Can be made smaller. In this way, by continuously reducing the rigidity of the rigidity adjusting portion 24 toward the distal end side, the rigidity is also reduced at the connecting portion of the outer shaft 14 between the distal shaft 21 and the proxy shaft 22. It becomes possible to make it continuously smaller toward the end side. Still further, the function of the rigidity adjusting portion 24 is not provided as a core wire separately from the tubular base 23, but is formed integrally with the tubular base 23 so that the rigidity adjusting portion 24 is on the extension line of the wall portion of the tubular base 23. In the cross section of the inner lumen 14a of the outer shaft 14, the region occupied by the rigidity adjusting portion 24 can be kept narrow. Therefore, the rigidity adjusting unit 24 can be provided while suppressing a decrease in fluid flow efficiency.
  • the stiffness adjusting portion 24 there is no limitation to the configuration in which both the thickness dimension and the width dimension are reduced toward the distal end side, and only one of the dimensions is directed toward the distal end side. It is good also as a structure made small. Further, the range in which the thickness dimension of the rigidity adjusting portion 24 decreases toward the distal end side may be the entire longitudinal range, and a part of the longitudinal direction not including the distal end portion and the root portion. It may be a range. Further, the range in which the width dimension of the rigidity adjusting portion 24 decreases toward the distal end side may be a partial range in the longitudinal direction, and in this case, the range not including the distal end portion and the root portion. It may be.
  • the maximum thickness dimension is specifically 0.088 mm (88 ⁇ m), but is not limited to this, and may be in the range of 0.010 mm to 1.000 mm (10 ⁇ m to 1000 ⁇ m).
  • the maximum width dimension is specifically 0.32 mm, but is not limited to this and may be in the range of 0.1 mm to 2.0 mm.
  • a pair of entry holes 31, 32 are formed at the distal end of the tubular base 23 so as to sandwich the root portion 24a of the stiffness adjusting portion 24 around the axis.
  • These entry holes 31 and 32 are linearly formed so as to enter the proximal end side from the distal end portion of the tubular base 23, and the wall portion of the proximal shaft 22 is arranged in the thickness direction (or radial direction). ) And is open toward the distal end side.
  • the extending direction of the pair of entering hole portions 31 and 32 intersects the axial direction of the tubular base 23 so that the distance between the entering hole portions 31 and 32 gradually increases toward the proximal side. Yes. Further, the pair of entry holes 31 and 32 are not formed in a straight line, but are formed in a curved shape so as to protrude toward the side between the entry holes 31 and 32.
  • the positions on the distal end side and the proximal end side of the entry hole portions 31 and 32 are the same between the entry hole portions 31 and 32. However, even if at least one of the position on the distal end side and the position on the proximal end side of the entry hole portions 31 and 32 is different between the entry hole portions 31 and 32 in the axial direction of the proxy shaft 22. Good. Further, the proximal end portions 31a and 32a of the respective entry hole portions 31 and 32 are formed wider than the continuous region on the distal side, and further, the peripheral surfaces are formed in a curved shape. Has been.
  • the width dimension of the intermediate part of the entrance holes 31 and 32 is set to be slightly larger than the width of the slit 26 in the rigidity reduction region 25. Specifically, it is 0.050 mm (50 ⁇ m). However, the present invention is not limited to this, and may be in the range of 0.025 mm to 1.000 mm (25 ⁇ m to 1000 ⁇ m).
  • the root portion of the rigidity adjusting portion 24 enters the distal end portion of the tubular base 23.
  • the tubular base 23 and the rigidity adjusting portion 24 Even if a large load is applied to the boundary portion, the load is suitably received also in the tubular base 23, and the possibility that the root portion of the stiffness adjusting portion 24 is damaged is reduced.
  • the distance between the pair of entry holes 31 and 32 is formed so as to increase toward the proximal end side, the rigidity can be smoothly changed at the root portion of the rigidity adjusting portion 24. (That is, it becomes possible to continuously increase the rigidity toward the proximal end side in the root portion of the rigidity adjusting portion 24).
  • the wall portion of the tubular base 23 with respect to the root portion of the rigidity adjusting portion 24 with the pair of entering hole portions 31 and 32 interposed therebetween. Will be adjacent around the axis. That is, the adjacent region 23 b exists at the distal end portion of the tubular base 23.
  • the slit 26 of the reduced rigidity region 25 formed in the tubular base 23 is formed so that the distal tip 26a reaches the position of the adjacent region 23b. . That is, the distal end 26a of the slit 26 is at the same position in the axial direction as the proximal end of the root portion of the stiffness adjusting portion 24, as indicated by the one-dot chain line in FIG.
  • the rigidity adjusting unit 24 and the rigidity reduction region 25 can be configured to be continuous in the axial direction (however, discontinuous in the direction around the axis). Therefore, in the continuous part of the rigidity adjusting part 24 and the tubular base 23, the rigidity can be continuously reduced toward the distal end side.
  • a series of through-holes 33 are formed between the pair of entry hole portions 31 and 32 from the tubular base 23 side to the rigidity adjusting portion 24 side.
  • the through hole 33 penetrates the tubular base 23 and the rigidity adjusting portion 24 in the thickness direction (or radial direction).
  • the through hole 33 is not continuous with the end portion of the tubular base 23 in the axial direction.
  • the through-hole 33 is formed so that the hole width gradually becomes narrower toward the distal side, whereby the distance between each of the entrance hole portions 31 and 32 and the through-hole 33, more specifically, around the axis. The distance is gradually increased toward the proximal side.
  • the through-hole 33 By forming the through-hole 33 as described above, it is possible to continuously reduce the rigidity toward the distal end side at the continuous portion of the rigidity adjusting portion 24 and the tubular base 23, and Since the rigidity adjusting portion 24 is suppressed from becoming extremely narrow toward the root portion, it is possible to achieve such a continuous decrease in rigidity while increasing the strength of the root portion of the rigidity adjusting portion 24. .
  • the connection between the proxy shaft 22 and the distal shaft 21 is performed on the proximal end side with respect to the rigidity reduction region 25, and the rigidity adjusting portion 24 is connected to the distal shaft 21. It has not been. However, a part of the rigidity adjusting unit 24 may be joined to the distal shaft 21. Further, as described above, the rigidity adjusting portion 24 is formed in a tapered shape in which the outer peripheral surface gradually enters inward toward the distal end side. When inserting into the proximal end side of the tar shaft 21, it becomes difficult for the rigidity adjusting portion 24 to be caught on the wall portion of the distal shaft 21.
  • a metal tube 41 made of stainless steel is prepared.
  • the metal tube 41 is formed so that its outer diameter is the same in the entire axial direction, and its inner diameter is also the same in the entire axial direction. These outer diameter and inner diameter are set as the outer diameter and inner diameter of the tubular base 23.
  • the outer peripheral surface of the end portion of the metal tube 41 is polished so that a continuous tapered surface 42 tapering toward the end portion is formed. This end becomes the distal end of the proximal shaft 22. Further, the dimension in the axial direction of the region to be polished corresponds to a region in which the thickness dimension is continuously decreased toward the distal end side in the rigidity adjusting portion 24.
  • polishing using a grindstone is performed, but the present invention is not limited to this, and electrolytic polishing or chemical polishing may be performed.
  • the metal tube 41 in the state of FIG. 3B is irradiated with a laser to cut the metal tube 41.
  • the tubular base 23 and the rigidity adjusting portion 24 are integrally formed, and the tubular base 23 is formed with the slits 26 of the reduced rigidity region 25, and the rigidity is reduced.
  • the adjustment part 24 is in a state where the dimension in the thickness direction and the dimension in the width direction are continuously reduced toward the distal end side.
  • a pair of entry hole portions 31, 32 and a through hole 33 are formed.
  • the formation of the outer shaft 14 is completed by inserting the proxy shaft 22 into the distal shaft 21 and joining them together. Further, the inner shaft 15 is inserted into the outer shaft 14 and the tip tip body 17 and Formation of the balloon catheter 10 is completed by joining the balloon 13.
  • a guiding catheter is first inserted into a sheath introducer inserted into a blood vessel and introduced to the coronary artery entrance.
  • the guide wire is inserted into the wire lumen and guiding catheter of the balloon catheter 10 and introduced from the coronary artery entrance to the peripheral site through the treatment target site (for example, a stenosis site).
  • the balloon catheter 10 is introduced to the treatment target site along the guide wire.
  • the balloon 13 is inflated with the pressurizer to perform the treatment, and when the expansion of the treatment target site is completed, the balloon 13 is deflated with the decompressor to extract the balloon catheter 10.
  • the rigidity adjusting portion 24 is integrally formed with the tubular base 23, the cost can be reduced as compared with a configuration in which the function of the rigidity adjusting portion 24 is provided as a core wire separately from the tubular base 23. Further, when the proximal shaft 22 is manufactured, it is possible to form the rigidity adjusting portion 24 when forming the rigidity-decreasing region 25 by laser cutting, so compared with the case where the core wire is joined to the tubular base 23, The manufacturing process can be simplified. Further, compared to the case where the core wire is joined to the tubular base 23, it is possible to prevent the rigidity from becoming extremely high at the continuous portion of the rigidity adjusting portion 24 and the tubular base 23.
  • the rigidity adjusting portion 24 can be provided without reducing the lumen cross-sectional area of the proximal shaft 22, a wide cross-sectional area of the contrast agent can be secured when the balloon 13 is expanded and contracted, and the balloon 13 is contracted. Time can be shortened.
  • the base portion of the stiffness adjusting portion 24 since the base portion of the stiffness adjusting portion 24 has entered the tubular base 23 side by forming the pair of entry holes 31 and 32, the tubular base 23 and the stiffness adjusting portion in the proxy shaft 22. Even if a large load is applied to the boundary portion with 24, the load can be suitably received also in the tubular base 23. Therefore, the possibility that the base portion of the rigidity adjusting unit 24 is damaged is reduced. Furthermore, since the pair of entry hole portions 31 and 32 are formed so that the distance between them becomes wider toward the proximal side, the strength of the root portion of the rigidity adjusting portion 24 can be increased. .
  • the rigidity reduction region 25 is the spiral slit 26
  • the distal tip 26 a of the slit 26 is far from the tubular base 23. It is necessary to make some distance from the proximal end to the proximal side. In this case, there is a concern that the distal end portion of the tubular base 23 is more rigid than the proximal side.
  • the distal tip 26a of the slit 26 is formed up to the position of the adjacent region 23b of the tubular base 23, and is closer to the distal end of the tubular base 23 than the distal tip 26a of the slit 26.
  • Is formed with a pair of entry holes 31, 32, the slit 26 and the entry holes 31, 32 are continuous in the axial direction.
  • the slit 26 and the rigidity adjusting portion 24 are continuous in the axial direction. To do. Therefore, even if it is the structure using the spiral slit 26 as the rigidity reduction area
  • FIG. 4A is a development view of the proxy shaft 22 in the present embodiment, and is an enlarged view showing a continuous portion of the tubular base 23 and the rigidity adjusting portion 24.
  • the distal tip 52a of the slit 52 constituting the rigidity reduction region 51 is more distal than the proximal end of the root portion of the stiffness adjusting portion 24. Is located. That is, the distal tip 52 a enters the adjacent region 23 b of the tubular base 23.
  • the distal end 52 a of the slit 52 is discontinuous with respect to the entry hole 31, but is present at a position close to the entry hole 31.
  • the distal end 52a of the slit 52 is formed wider than the region continuous on the proximal side, and further, the peripheral surface is formed in a curved shape. Accordingly, when the slit 52 is formed, when the proxy shaft 22 or the balloon catheter 10 is transported, or when the balloon catheter 10 is used, the entrance hole 31 or the distal end of the tubular base 23 is distant from the distal end of the slit 52. Generation of cracks toward the end is suppressed.
  • the shape of the through hole 53 formed between the pair of entry hole portions 31 and 32 is different from that of the first embodiment.
  • the through-hole 53 has a shape in which the proximal end side is recessed toward the distal end side.
  • the through hole 53 is formed from the tubular base 23 side to the rigidity adjusting portion 24 side, and the through holes 31 and 32 are penetrated. The distance from the hole 53 is formed so as to gradually increase toward the proximal side.
  • the through hole 33 is not formed in the present embodiment.
  • the rigidity of the proxy shaft 22 may greatly change at the boundary portion between the tubular base 23 and the rigidity adjusting portion 24 due to the formation of the pair of entrance holes 31 and 32. It can be suppressed. Further, it is possible to increase the strength of the base portion of the rigidity adjusting portion 24 as compared with the configuration in which the through hole 33 is formed.
  • the linear portion that is present on the most distal side in the slit 62 that constitutes the reduced rigidity region 61 crosses the proximal side with respect to the pair of entrance holes 31 and 32, and The distal end 62a is located more distally than the proximal ends of the entry holes 31 and 32.
  • the distal tip 62a has a shape for preventing cracks as in the case of FIG.
  • the pair of entry holes 65 and 66 are not linear but concave.
  • the stiffness greatly changes at the boundary portion between the tubular base 23 and the stiffness adjusting portion 24. Is suppressed.
  • the pair of entry holes 31 and 32 are not formed in a curved shape, but may be formed in a linear shape. Even in this case, it is preferable to form the linear entry holes 31 and 32 so that the distance between the pair of entry holes 31 and 32 increases toward the proximal side.
  • the rigidity reduction portion formed in the tubular base 23 is not limited to the spiral slit 26, but is a linear or curved and non-spiral slit extending in the axial direction, or a plurality of through holes. A configuration in which the dots are formed in a scattered manner is also conceivable. Moreover, the structure which forms a rigidity reduction part by setting it as mesh shape is also considered. In any of these configurations, it is preferable to form the rigidity reducing portion in the tubular base 23 up to the position of the adjacent region 23b adjacent to the root portion of the rigidity adjusting portion 24 and the axis. Further, the rigidity adjusting portion 24 is formed. You may form to the position of the distal side rather than the proximal end part of the root part.
  • the configuration in which the entry holes 31 and 32 are formed in the tubular base 23 may be applied to a configuration in which the rigidity adjusting portion is provided as a core wire separately from the tubular base 23.
  • the load applied to the joint portion between the core wire and the tubular base 23 is formed by the pair of entry holes 31 and 32 being formed so as to sandwich the joint portion between the core wire and the tubular base 23 around the axis. Can be absorbed by deformation of the tubular base 23. Therefore, it becomes possible to regulate the separation of the core wire.
  • the core wire is joined by forming the entry holes 31 and 32 so that the distance between the pair of entry holes 31 and 32 increases toward the proximal side. It is possible to smoothly change the rigidity in the part.
  • the proxy shaft 22 may be made of synthetic resin.
  • a resin tube may be prepared instead of the metal tube 41, and when forming the tapered surface 42, heat molding may be performed.
  • the pair of entry holes 31 and 32 do not have to be symmetrical with respect to the root portion of the rigidity adjusting portion 24, and may be asymmetric. Moreover, it is not limited to the configuration in which only a part of the through hole 33 is disposed between the pair of entry holes 31 and 32, and the entire through hole 33 is disposed between the pair of entry holes 31 and 32. May be.
  • occlusion part in the said blood vessel through the structure of each said embodiment which concerns on the rigidity adjustment part 24 and a pair of entrance hole parts 31 and 32 through the blood vessel.
  • the present invention may be applied to in vivo “tubes” such as ureters and digestive tracts other than blood vessels, and balloon catheters inserted into body cavities.
  • the above configuration includes a connection tube formed by connecting a plurality of tubes in the axial direction, and other types in which fluid is circulated in the lumen of the connection tube in use. You may apply with respect to the catheter of this.
  • the present invention may be applied to a thrombus suction catheter.
  • the above configuration may be applied to a catheter having a shaft portion formed by connecting a plurality of non-tube-shaped shafts arranged in the axial direction. Further, the above-described configuration may be applied to a medical instrument of a type different from the catheter, although it is inserted into the living body when used. For example, the above configuration may be applied to a shaft portion in an insertion assisting tool for facilitating insertion of a catheter into a living body or a treatment target site.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

La présente invention concerne une tige médicale capable d'augmenter considérablement l'opérabilité d'instruments médicaux ayant une partie de tige, et un instrument médical pourvu de ladite tige médicale. Une tige proximale (22) est formée de façon intégrée d'une base tubulaire (23) constituant l'extrémité proximale d'une tige extérieure, et d'une unité d'ajustement de rigidité (24) qui s'étend vers l'extrémité distale depuis ladite base tubulaire (23). Une paire de trous d'entrée (31, 32) sont formés dans l'extrémité distale de la base tubulaire (23) autour de l'axe de chaque côté d'une partie de base de l'unité d'ajustement de rigidité (24). Ces trous d'entrée (31, 32) sont formés linéairement de manière à permettre l'entrée de l'extrémité distale vers le côté proximal de la base tubulaire (23). Les trous d'entrée (31, 32) pénètrent dans la paroi de la tige proximale (22) dans la direction de l'épaisseur de celle-ci, et s'ouvrent sur le côté distal. La paire de trous d'entrée (31, 32) est formée de sorte que la distance entre les trous d'entrée (31, 32) augmente progressivement vers l'extrémité proximale.
PCT/JP2010/058937 2010-05-26 2010-05-26 Tige médicale et instrument médical WO2011148479A1 (fr)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2012517048A JP5486679B2 (ja) 2010-05-26 2010-05-26 医療用シャフト及び医療用器具
PCT/JP2010/058937 WO2011148479A1 (fr) 2010-05-26 2010-05-26 Tige médicale et instrument médical

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/JP2010/058937 WO2011148479A1 (fr) 2010-05-26 2010-05-26 Tige médicale et instrument médical

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WO2011148479A1 true WO2011148479A1 (fr) 2011-12-01

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JP (1) JP5486679B2 (fr)
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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013233202A (ja) * 2012-05-07 2013-11-21 Goodman Co Ltd 医療用シャフトおよび医療用器具
CN110870793A (zh) * 2018-08-31 2020-03-10 新加坡国立大学 机械臂、微创手术机器人及其制造方法
JP2020116263A (ja) * 2019-01-25 2020-08-06 テルモ株式会社 カテーテル

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001137348A (ja) * 1999-11-12 2001-05-22 Goodman Co Ltd カテーテル
JP2001333984A (ja) * 2000-05-30 2001-12-04 Kawasumi Lab Inc バルーンカテーテル
JP2005514123A (ja) * 2001-12-28 2005-05-19 シメッド　ライフ　システムズ　インコーポレイテッド ひずみの解放を改良したハイポチューブ
JP2006187315A (ja) * 2004-12-28 2006-07-20 Terumo Corp カテーテル

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2001137348A (ja) * 1999-11-12 2001-05-22 Goodman Co Ltd カテーテル
JP2001333984A (ja) * 2000-05-30 2001-12-04 Kawasumi Lab Inc バルーンカテーテル
JP2005514123A (ja) * 2001-12-28 2005-05-19 シメッド　ライフ　システムズ　インコーポレイテッド ひずみの解放を改良したハイポチューブ
JP2006187315A (ja) * 2004-12-28 2006-07-20 Terumo Corp カテーテル

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2013233202A (ja) * 2012-05-07 2013-11-21 Goodman Co Ltd 医療用シャフトおよび医療用器具
CN110870793A (zh) * 2018-08-31 2020-03-10 新加坡国立大学 机械臂、微创手术机器人及其制造方法
CN110870793B (zh) * 2018-08-31 2024-04-05 新加坡国立大学 机械臂、微创手术机器人及其制造方法
JP2020116263A (ja) * 2019-01-25 2020-08-06 テルモ株式会社 カテーテル
JP7312556B2 (ja) 2019-01-25 2023-07-21 テルモ株式会社 カテーテル

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