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WO2016056439A1 - Dilatateur et ensemble cathéter - Google Patents

Dilatateur et ensemble cathéter Download PDF

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Publication number
WO2016056439A1
WO2016056439A1 PCT/JP2015/077665 JP2015077665W WO2016056439A1 WO 2016056439 A1 WO2016056439 A1 WO 2016056439A1 JP 2015077665 W JP2015077665 W JP 2015077665W WO 2016056439 A1 WO2016056439 A1 WO 2016056439A1
Authority
WO
WIPO (PCT)
Prior art keywords
connector
dilator
dilator shaft
guiding catheter
catheter
Prior art date
Legal status (The legal status 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 status listed.)
Ceased
Application number
PCT/JP2015/077665
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English (en)
Japanese (ja)
Inventor
篤史 成瀬
伸 牛田
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Goodman Co Ltd
Original Assignee
Goodman Co Ltd
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 Goodman Co Ltd filed Critical Goodman Co Ltd
Publication of WO2016056439A1 publication Critical patent/WO2016056439A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters

Definitions

  • the present invention relates to a dilator and a catheter assembly.
  • a device such as a balloon catheter
  • an introduction hole that leads from the body surface into the blood vessel is first formed.
  • the sheath introducer is introduced into the blood vessel through the hole.
  • a dilator is mounted inside the sheath introducer.
  • the dilator is mounted in a state in which a part thereof protrudes from the distal end of the sheath introducer to the distal end side.
  • a portion of the dilator that protrudes from the tip of the sheath introducer is referred to as a protruding portion.
  • the user When the user introduces the sheath introducer into the blood vessel, the user introduces the sheath introducer into the blood vessel while expanding the hole with the protruding portion of the dilator.
  • the user is, for example, a doctor.
  • a guiding catheter is introduced into the blood vessel through the inside of the sheath introducer.
  • a device such as a balloon catheter is introduced into the blood vessel through the inside of the guiding catheter.
  • the introduction hole is expanded by the outer diameter of the sheath introducer.
  • the size of the hole is as small as possible. Therefore, in recent years, a method has been proposed in which a guiding catheter is directly introduced into a blood vessel without using a sheath introducer. Not using a sheath introducer is also called sheathless. According to this method, the size of the hole is only required to be approximately the same as the outer diameter of the guiding catheter, so that the burden on the patient can be reduced.
  • Patent Document 1 discloses a guiding catheter assembly including a guiding catheter and a dilator attached to the inside of the guiding catheter.
  • the dilator has a connector at its proximal end, and the connector is connected to the proximal end of the guiding catheter.
  • the dilator has a protruding portion protruding from the distal end of the guiding catheter.
  • a guiding catheter is introduced to the vicinity of a treatment target site in a blood vessel. Therefore, when introducing the above-described guiding catheter assembly into a blood vessel, the guiding catheter assembly may pass through a bent blood vessel.
  • the rigidity since the guiding catheter assembly has a double structure of the guiding catheter and the dilator, the rigidity may be relatively high. When the rigidity is high, it may be difficult for the guiding catheter assembly to follow the bent blood vessel when passing through the bent blood vessel.
  • the present invention has been made in view of the above circumstances, and a main object of the present invention is to provide a dilator and a catheter assembly that can improve operability when a catheter is introduced into the body.
  • a dilator is a dilator comprising: a dilator shaft that can be inserted through a catheter; and a connector having a connection portion configured to be connectable to a proximal end side of the catheter.
  • the connecting portion is configured to be displaceable in the axial direction with respect to the dilator shaft.
  • the dilator is attached to the catheter by inserting the dilator shaft into the catheter and connecting the connector to the proximal end side of the catheter.
  • a part of the dilator shaft protrudes from the distal end of the catheter.
  • a portion protruding from the catheter tip is also referred to as a protruding portion.
  • the catheter assembly generally has a double structure of a dilator shaft and a catheter. However, the projecting portion consists only of the dilator shaft. Therefore, the flexibility of the protruding portion is higher than the flexibility of the double structure portion closer to the base end side than the protruding portion.
  • the dilator has an adjustment function capable of adjusting the length of the protruding portion.
  • the connecting portion of the connector can be displaced in the axial direction with respect to the dilator shaft.
  • the catheter connected to the connecting portion can be displaced (relatively displaced) in the axial direction with respect to the dilator shaft.
  • the length of the protruding portion protruding from the distal end of the catheter can be adjusted by displacing the relative position between the catheter and the dilator shaft.
  • the flexibility of the distal end side of the catheter assembly can be increased by increasing the length of the protruding portion.
  • trackability with respect to a bending blood vessel can be improved.
  • the rigidity of the distal end side of the catheter assembly can be increased by reducing the length of the protrusion (reducing flexibility). be able to).
  • malfunctions, such as a tip side kinking can be controlled. Therefore, in this case, the operability when introducing the catheter into the body can be improved.
  • the “connecting portion connected to the proximal end side of the catheter” includes not only a connecting portion directly connected to the proximal end side of the catheter but also a connector (for example, a hemostasis connector) or the like on the proximal end side of the catheter.
  • a connection part connected via a member is also included.
  • the dilator of the second invention is configured to be switchable between a fixed state in which the connector is fixed to the dilator shaft and a release state in which the connector is released from the dilator shaft. It can be displaced in the axial direction with respect to the dilator shaft.
  • the connector (including the connecting portion) can be displaced in the axial direction with respect to the dilator shaft. Therefore, the user can adjust the length of the protrusion by displacing the connector in the axial direction. Thereby, compared with the case where the displacement mechanism which displaces a connection part to an axial direction is provided in a connector, simplification of a structure can be achieved.
  • a dilator according to a third invention is the dilator according to the second invention, wherein the connector has an insertion portion through which the dilator shaft is inserted, and in the released state, the connector is along the dilator shaft inserted through the insertion portion. It is configured to be displaceable in the axial direction.
  • the connector can move (displace) in the axial direction along the dilator shaft inserted through the insertion portion.
  • the connector can be guided along the dilator shaft, the operation of adjusting the length of the protruding portion by moving the connector can be facilitated.
  • the insertion part is preferably an insertion hole part through which the dilator shaft is inserted.
  • the connector when the connector is moved in the axial direction along the dilator shaft, the connector does not come off the dilator shaft. Therefore, the operation of adjusting the length of the protruding portion can be further facilitated.
  • a dilator according to a fourth invention is the dilator according to the second or third invention, wherein the connector includes an annular elastic member surrounding an outer periphery of the dilator shaft, a compression position for compressing the elastic member in an axial direction, and the elastic member.
  • a pair of bodies configured to be capable of relative displacement with respect to a compression release position that does not apply force to the inner circumference of the compressed elastic member when the pair of bodies are in the compression position.
  • an annular elastic member surrounding the outer periphery of the dilator shaft is provided.
  • the elastic member is switched between a compressed state in which the elastic member is compressed in the axial direction and a compressed release state in which the compression is released by relative displacement of the pair of bodies.
  • the elastic member when the elastic member is in a compressed state, the inner peripheral portion of the elastic member is pressed against the outer peripheral surface of the dilator shaft, and the connector is fixed to the dilator shaft (becomes a fixed state).
  • the dilator shaft is not easily crushed. Therefore, it is possible to fix the connector to the dilator shaft while suppressing a decrease in the insertability of the guide wire inserted through the lumen of the dilator shaft.
  • a dilator according to a fifth invention is characterized in that, in any one of the first to fourth inventions, the catheter is a guiding catheter.
  • a dilator is mounted inside a guiding catheter (sheathless guiding catheter) that is introduced into the body without using a sheath introducer.
  • the guiding catheter is introduced to the vicinity of the treatment target site in the body. Therefore, the guiding catheter has a high possibility of passing through the bent blood vessel during the introduction. Therefore, in the present invention, the dilator of the first invention is applied to the guiding catheter.
  • the length of the protruding portion can be increased to improve the followability to the bent blood vessel, so that the operability when introducing the guiding catheter into the body is improved. Can be increased.
  • a catheter assembly of a sixth invention includes the catheter and the dilator of any one of the first to fifth inventions, and the dilator shaft is inserted into the catheter in the state of the catheter.
  • a projecting portion projecting from a distal end, and the connecting portion is connected to a proximal end side of the catheter, and the projecting portion is displaced in an axial direction with respect to the dilator shaft together with the catheter. The length of can be adjusted.
  • the same effects as those of the first to fifth inventions can be obtained as a catheter assembly.
  • FIG. 3 is a schematic overall side view showing a configuration of a guiding catheter assembly.
  • A is a front view which shows the guiding catheter by which the hemostatic connector was connected to the base end side
  • (b) is a longitudinal cross-sectional view which expands and shows the periphery of the hemostatic connector
  • (c) is a guiding catheter. It is a longitudinal cross-sectional view which expands and shows the front-end
  • (A) is a front view which shows the structure of a dilator
  • (b) is a longitudinal cross-sectional view which expands and shows the hub periphery of a dilator.
  • (A) is the front view which expands and shows the connector periphery
  • (b) is the cross-sectional view which expanded the connector periphery and was seen from the base end side. It is the longitudinal cross-sectional view which expands and shows the periphery of a connector, (a) has shown the fixed state with which the connector was fixed to the dilator shaft, (b) has shown the cancellation
  • (A) is the longitudinal cross-sectional view which expands and shows the connection part by which the connector of the dilator was connected to the base end side of the guiding catheter
  • (b) is the front view which expands and shows the connection part. It is a front view which shows a mode that the length of a protrusion part is adjusted. The figure for demonstrating the work content at the time of introduce
  • FIG. 1 is a schematic overall side view showing a configuration of a guiding catheter assembly.
  • FIG. 2A is a front view showing a guiding catheter having a hemostatic connector connected to the proximal end side.
  • FIG. 2B is an enlarged longitudinal sectional view showing the periphery of the hemostatic connector.
  • FIG. 2C is a longitudinal sectional view showing an enlarged distal end portion of the guiding catheter.
  • the guiding catheter assembly 10 includes a guiding catheter 11 and a dilator 12.
  • the dilator 12 is inserted into the guiding catheter 11.
  • the guiding catheter assembly 10 is used when a device such as a balloon catheter is introduced into a treatment target site in a peripheral blood vessel.
  • the length of the guiding catheter assembly 10 is, for example, about 500 mm to 1500 mm as a whole.
  • the guiding catheter assembly 10 corresponds to a “catheter assembly”, and the guiding catheter 11 corresponds to a “catheter”.
  • the guiding catheter 11 includes a catheter shaft 14 and a hub 15.
  • the hub 15 is connected to the proximal end side of the catheter shaft 14.
  • the catheter shaft 14 is formed with a lumen 14a extending in the entire axial direction.
  • the catheter shaft 14 has a three-layer structure including an inner layer 14b, a braided layer 14d (intermediate layer), and an outer layer 14c.
  • the inner layer 14b and the outer layer 14c are formed of a resin material.
  • the braided layer 14d (intermediate layer) is located between the inner layer 14b and the outer layer 14c.
  • the braided layer 14d (intermediate layer) is made of metal. Further, the distal end portion of the catheter shaft 14 is tapered. As a result, the catheter shaft 14 is more easily inserted into the blood vessel.
  • an internal passage 15 a is formed in the hub 15 that extends over the entire axial direction of the hub 15.
  • the hub 15 is formed of a resin material having transparency.
  • the proximal end portion of the catheter shaft 14 is inserted on the distal end side of the internal passage 15a.
  • the proximal end portion of the catheter shaft 14 is joined to the hub 15 while being inserted into the hub 15.
  • the internal passage 15 a communicates with the lumen 14 a of the catheter shaft 14.
  • the internal passage 15a is a tapered passage portion 16 that increases in diameter from a predetermined position toward the base end.
  • An annular projecting portion 18 is provided on the outer peripheral surface of the base end portion of the hub 15.
  • a male screw portion (not shown) is formed on the protruding portion 18.
  • a rubber cover 19 is attached to the front end side of the hub 15. The proximal end side of the catheter shaft 14 is covered with a rubber cover 19.
  • a hemostatic connector 21 having a hemostatic function is connected to the proximal end side of the hub 15.
  • the hemostatic connector 21 has a hub connecting portion 22 and a hemostatic portion 23.
  • the hub connection portion 22 is connected to the proximal end side of the hub 15.
  • the hemostatic part 23 is provided on the proximal end side of the hub connection part 22.
  • the hub connection portion 22 is formed of a transparent resin material.
  • the hub connection part 22 includes a cylindrical part 25, an inner plate part 26, and a connection pipe part 27.
  • the cylindrical portion 25 is a cylindrical portion extending in the axial direction.
  • the inner plate portion 26 is a disc-shaped portion provided inside the cylindrical portion 25.
  • the connecting pipe portion 27 is a circular tubular portion extending from the inner plate portion 26 to the distal end side.
  • a female thread portion 25 a is formed on the inner peripheral surface of the cylindrical portion 25 on the tip side of the inner plate portion 26.
  • a plurality of ribs 25b extending in the axial direction are provided on the outer peripheral surface of the cylindrical portion 25 at predetermined intervals in the circumferential direction.
  • a tube hole 27 a extending in the axial direction of the connection tube portion 27 is formed inside the connection tube portion 27.
  • the tube hole 27a penetrates the connecting tube portion 27 and the inner plate portion 26 in the axial direction.
  • the connecting pipe portion 27 is inserted into the internal passage 15a of the hub 15 from the proximal end side.
  • the connecting pipe portion 27 is inserted into the tapered passage portion 16 from the proximal end side.
  • the cylindrical portion 25 is located on the outer peripheral side of the hub 15, and the female screw portion 25 a is fastened to the male screw portion of the protruding portion 18 of the hub 15.
  • the hub connection portion 22 is connected to the hub 15. That is, the hemostatic connector 21 is connected to the hub 15.
  • the hemostasis part 23 includes a main body part 31, a hemostasis valve 32, and a cap 33.
  • the main body 31 is formed in a cylindrical shape from a transparent resin material. Inside the main body 31, an internal passage 31 a is formed that extends over the entire axial direction of the main body 31.
  • the main body 31 includes a reduced diameter portion 31b.
  • the reduced diameter portion 31 b is located on the distal end side in the main body portion 31.
  • the reduced diameter portion 31b is a portion having a smaller outer diameter and inner diameter than the portion on the proximal end side of the reduced diameter portion 31b in the main body portion 31.
  • the reduced diameter portion 31b is inserted into the hub connection portion 22 from the proximal end side.
  • the distal end portion of the reduced diameter portion 31 b is in contact with the inner plate portion 26 of the hub connection portion 22.
  • the reduced diameter portion 31 b is joined to the hub connection portion 22 while being inserted into the hub connection portion 22.
  • the internal passage 31 a of the main body portion 31 communicates with the tube hole 27 a of the connection tube portion 27.
  • the branch pipe part 35 protrudes from the outer peripheral surface of the main body part 31. Inside the branch pipe part 35, a pipe hole 35a communicating with the internal passage 31a is formed. A conduit 36 is connected to the branch pipe portion 35.
  • the conduit 36 is configured to be connectable with a liquid agent supplier (not shown) for supplying a liquid agent such as a contrast medium into the body.
  • the protruding portion 37 protrudes from the outer peripheral surface of the main body portion 31.
  • the protrusion 37 has a rectangular shape, and is provided on a part of the main body 31 in the circumferential direction. Further, the protrusion 37 is located on the proximal end side with respect to the branch pipe portion 35.
  • the main body 31 is formed separately from the hub connection 22.
  • the main body portion 31 may be formed integrally with the hub connection portion 22.
  • a hemostasis valve 32 is provided at the base end of the main body 31.
  • the hemostasis valve 32 is formed in a disk shape from an elastic material such as silicon rubber.
  • the hemostatic valve 32 is arranged so as to close the proximal end opening of the internal passage 31a.
  • the hemostasis valve 32 is formed with a slit 32 a that penetrates the hemostasis valve 32 in the thickness direction.
  • the cap 33 is formed of the same resin material as that of the main body 31.
  • the cap 33 has an accommodation recess 33 a for accommodating the hemostasis valve 32.
  • the cap 33 is fixed on the base end portion of the main body 31 in a state where the hemostasis valve 32 is housed in the housing recess 33a. Thereby, the hemostatic valve 32 is built in the hemostatic part 23.
  • the cap 33 is formed with a hole 33 b that communicates with the slit 32 a of the hemostasis valve 32.
  • the hole 33b, the accommodating recess 33a, the internal passage 31a, and the tube hole 27a constitute a connector passage 39 of the hemostatic connector 21.
  • the connector passage 39 penetrates the hemostatic connector 21 in the axial direction.
  • FIG. 3A is a front view showing the configuration of the dilator 12.
  • FIG. 3B is an enlarged longitudinal sectional view showing the periphery of the hub of the dilator 12.
  • the dilator 12 includes a dilator shaft 41 and a connector 43.
  • the connector 43 can be connected to the hemostatic connector 21.
  • a hub 42 is connected to the proximal end side of the dilator shaft 41.
  • the dilator shaft 41 is formed in a tubular shape from a flexible resin material.
  • the dilator shaft 41 is made of, for example, a fluororesin.
  • the dilator shaft 41 is not necessarily formed of a fluororesin, and may be formed of other resin materials such as polyethylene, polypropylene, polyester, nylon, nylon elastomer, and the like.
  • the dilator shaft 41 is formed with a lumen 41 a extending over the entire axial direction inside the dilator shaft 41.
  • the lumen 41a functions as a guide wire lumen through which the guide wire is inserted.
  • the tip of the dilator shaft 41 is tapered. Thereby, the insertability of the dilator shaft 41 into the blood vessel is enhanced.
  • the hub 42 is formed into a tubular shape from a transparent resin material.
  • an internal passage 42a is formed in the hub 42 so as to extend over the entire area in the axial direction.
  • the proximal end portion of the dilator shaft 41 is inserted into the distal end side of the internal passage 42a.
  • the proximal end portion of the dilator shaft 41 is joined to the hub 42 while being inserted into the internal passage 42a.
  • the internal passage 42 a of the hub 42 communicates with the lumen 41 a of the dilator shaft 41.
  • the opening on the proximal end side in the internal passage 42 a of the hub 42 is a connection port 46.
  • connection port 46 can be connected to a medicine supply device (not shown) for supplying medicine into the body through the lumen 41 a of the dilator shaft 41.
  • a rubber cover 47 that covers the proximal end side of the dilator shaft 41 is attached to the distal end side of the hub 42.
  • FIG. 4A is an enlarged front view showing the periphery of the connector 43.
  • FIG. 4B is a cross-sectional view in which the periphery of the connector 43 is enlarged from the base end side.
  • FIG. 5 is an enlarged longitudinal sectional view showing the periphery of the connector 43.
  • FIG. 5A shows a fixed state in which the connector 43 is fixed to the dilator shaft 41.
  • FIG. 5B shows a release state in which the fixation is released.
  • the connector 43 includes a first body 51 and a second body 52.
  • the second body 52 is located on the proximal end side of the first body 51.
  • the first body 51 is made of a resin material, for example, polyacetal.
  • the first body 51 is formed in a cylindrical shape extending in the axial direction as a whole.
  • the first body 51 includes a large diameter part 51a and a small diameter part 51b.
  • the large-diameter portion 51 a is a tip side portion of the first body 51.
  • the small diameter part 51b is a part closer to the base end than the large diameter part 51a.
  • the outer diameter of the small diameter part 51b is smaller than the outer diameter of the large diameter part 51a.
  • the large-diameter portion 51a is formed with a recess that opens toward the tip side.
  • the concave portion is an accommodating concave portion 53 that accommodates the hemostatic portion 23 of the hemostatic connector 21.
  • a guide passage 56 for guiding the protruding portion 37 of the hemostatic portion 23 is formed in the peripheral wall portion 54 surrounding the accommodating recess 53 in the large diameter portion 51a.
  • the guide passage 56 is a notch that penetrates the peripheral wall 54 in the thickness direction.
  • the guide passage 56 includes a first passage portion 56a and a second passage portion 56b.
  • the first passage portion 56a is a portion extending from the distal end of the peripheral wall portion 54 toward the proximal end side.
  • path part 56b is a part extended along the circumferential direction from the base end side (base end part) of the 1st channel
  • the first body 51 (mainly the small diameter portion 51b) is formed with a hole 58 extending from the housing recess 53 toward the base end side.
  • the hole 58 is formed at the center of the first body 51.
  • the hole 58 is opened to the outside of the first body 51 at the proximal end portion of the small diameter portion 51b.
  • the hole 58 has a small diameter hole 58a and a large diameter hole 58b.
  • the small-diameter hole 58a extends from the accommodation recess 53 toward the base end side.
  • the large diameter hole 58b extends from the proximal end of the small diameter hole 58a toward the proximal end to the proximal end opening of the hole 58.
  • Both the small-diameter hole 58a and the large-diameter hole 58b are formed on the same axis.
  • the hole diameter of the small diameter hole portion 58a is the same as or slightly larger than the outer diameter of the dilator shaft 41.
  • the hole diameter of the large diameter hole part 58b is larger than the hole diameter of the small diameter hole part 58a.
  • An internal thread 59 is formed on the inner peripheral surface of the small diameter hole 58a.
  • the large-diameter hole 58b functions as a screw hole.
  • the large-diameter hole 58b is also referred to as a screw hole 58b.
  • a step surface 62 is formed at the boundary portion between the small diameter hole portion 58a and the large diameter hole portion 58b.
  • the step surface 62 is a surface connecting the inner peripheral surfaces of the small diameter hole portion 58a and the large diameter hole portion 58b.
  • the step surface 62 is an inclined surface (tapered surface) that inclines radially outward from the distal end side (small diameter hole portion 58a side) toward the proximal end side (large diameter hole portion 58b side).
  • a plurality of ribs 61 extending along the axial direction are provided on the outer peripheral surface of the small diameter portion 51b at predetermined intervals (equal intervals) in the circumferential direction.
  • the rib 61 functions as a slip stopper that prevents the user from slipping when the user tightens or loosens the male screw portion 63 in the screw hole portion 58b while holding the outer peripheral surface of the small diameter portion 51b by hand.
  • the male screw part 63 will be described later.
  • the second body 52 is made of a resin material, for example, ABS.
  • the second body 52 is formed in a cylindrical shape extending in the axial direction as a whole.
  • the second body 52 has a male screw part 63.
  • the male screw part 63 is located on the distal end side in the second body 52.
  • the male screw part 63 is configured to be screwed into the screw hole part 58 b of the first body 51.
  • On the outer peripheral surface of the male screw portion 63 a male screw 63a that is screwed into the female screw 59 of the screw hole portion 58b is formed.
  • the second body 52 is integrated with the first body 51 by the male screw portion 63 being screwed into the screw hole portion 58b.
  • the hole 64 penetrating the second body 52 in the axial direction is formed.
  • the hole 64 is formed at the center of the second body 52.
  • the hole 64 has a small diameter hole 64a and a large diameter hole 64b.
  • the small diameter hole portion 64 a is a hole extending from the distal end opening of the hole portion 64 toward the proximal end side.
  • the large diameter hole portion 64b is a hole extending from the base end of the small diameter hole portion 64a toward the base end side.
  • the hole diameter of the small diameter hole 64a is the same as or larger than the outer diameter of the dilator shaft 41.
  • the hole diameter of the large diameter hole part 64b is larger than the hole diameter of the small diameter hole part 64a.
  • the hole diameter of the large-diameter hole 64b gradually increases from the distal end side toward the proximal end side. Thereby, the hole diameter of the base end opening of the large-diameter hole portion 64 b (and thus the hole portion 64) is sufficiently larger than the outer diameter of the dilator shaft 41.
  • the hole 64 of the second body 52 communicates with the hole 58 of the first body 51.
  • an internal passage 65 that penetrates the connector 43 in the axial direction is formed by the hole 58, the hole 64, and the housing recess 53 of the first body 51.
  • the dilator shaft 41 is inserted through the internal passage 65.
  • the internal passage 65 corresponds to the insertion part and the insertion hole part.
  • the distal end surface 66 surrounding the distal end opening of the hole 64 in the male screw portion 63 is a tapered surface formed so that the outer diameter increases from the distal end side toward the proximal end side.
  • the tip surface 66 faces the step surface 62 of the first body 51 in the axial direction.
  • the tip surface 66 is a surface parallel to the step surface 62.
  • the step surface 62 and the tip surface 66 are a pair of facing surfaces facing each other in the axial direction.
  • the pair of facing surfaces are not necessarily tapered surfaces, and may be surfaces orthogonal to the axial direction, for example.
  • a plurality of handle portions 68 projecting from the outer peripheral surface are provided on the proximal side of the second body 52 with respect to the male screw portion 63.
  • two handle portions 68 are provided.
  • Each handle portion 68 is provided at regular intervals (specifically, 180 ° intervals) around the axis.
  • an O-ring 69 is provided between the step surface 62 of the first body 51 and the tip surface 66 of the second body 52.
  • the O-ring 69 is an elastic member formed in an annular shape from a resin material having elasticity, and is provided so as to surround the outer peripheral surface of the dilator shaft 41.
  • the inner diameter of the O-ring 69 is the same as or slightly larger than the outer diameter of the dilator shaft 41. However, the inner diameter of the O-ring 69 may be slightly smaller than the outer diameter of the dilator shaft 41.
  • the O-ring 69 is configured such that the male screw part 63 of the second body 52 is tightened (screwed) into the screw hole part 58 b of the first body 51. Between the surface 62 and the front end surface 66 of the second body 52, it is compressed in the axial direction. In this case, the O-ring 69 is deformed on both sides in the radial direction in accordance with the compression in the axial direction. That is, the O-ring 69 extends toward the inner peripheral side and the outer peripheral side. As the O-ring 69 expands, the inner peripheral portion is pressed against the outer peripheral surface of the dilator shaft 41.
  • the entire inner peripheral portion of the O-ring 69 is pressed against the outer peripheral surface of the dilator shaft 41.
  • the O-ring 69 is fixed to the dilator shaft 41 by being pressed.
  • the connector 43 is fixed to the dilator shaft 41.
  • the relative position of the first body 51 and the second body 52 when the connector 43 is fixed to the dilator shaft 41 corresponds to the “compression position”.
  • the fixing of the connector 43 to the dilator shaft 41 is released.
  • the relative position of the first body 51 and the second body 52 when the fixing of the connector 43 to the dilator shaft 41 is released corresponds to the “compression release position”. That is, the compression release position is a relative position between the first body 51 and the second body 52 when no force is applied to the O-ring 69.
  • the connector 43 is configured to be switchable between a fixed state and a released state.
  • the fixed state is a state in which the connector 43 is fixed to the dilator shaft 41 (the state shown in FIG. 5A).
  • the released state is a state in which the fixation between the connector 43 and the dilator shaft 43 is released (the state shown in FIG. 5B).
  • the connector 43 can be moved (displaced) along the dilator shaft 41 in the axial direction. In this case, since the dilator shaft 41 is inserted into the internal passage 65 of the connector 43, the connector 43 can move (displace) in the axial direction along the inserted dilator shaft 41.
  • FIG. 6A is a longitudinal sectional view showing a connection portion where the connector 43 of the dilator 12 is connected to the proximal end side of the guiding catheter 11.
  • FIG. 6B is a front view showing a connection portion.
  • the dilator shaft 41 of the dilator 12 is inserted into the lumen 14 a of the catheter shaft 14 of the guiding catheter 11, the internal passage 15 a of the hub 15, and the connector passage 39 of the hemostatic connector 21. Yes.
  • the dilator shaft 41 includes a protrusion 71.
  • the protruding portion 71 is a portion that protrudes from the distal end of the catheter shaft 14 to the distal end side in the dilator shaft 41 in a state where the dilator shaft 41 is inserted.
  • the dilator shaft 41 is inserted into a slit 32 a of a hemostasis valve 32 provided in the hemostasis connector 21.
  • the outer peripheral surface of the dilator shaft 41 and the inner peripheral surface of the slit 32a are in close contact with each other. This prevents blood leakage through the dilator shaft 41 and the slit 32a.
  • the connector 43 of the dilator 12 is connected to the proximal end side of the hemostatic connector 21. Specifically, the connector 43 is connected to the proximal end side of the hemostatic part 23.
  • the hemostatic part 23 of the hemostatic connector 21 is accommodated in the accommodating recess 53 of the first body 51.
  • the projection 37 of the hemostatic part 23 (main body part 31) is the second passage part of the guide passage 56 of the first body 51. 56b. Thereby, the projection part 37 is engaged with the second passage part 56b. By this engagement, the first body 51 and thus the connector 43 are connected to the hemostatic connector 21.
  • the first body 51 corresponds to the connection portion.
  • the procedure for connecting the connector 43 to the proximal end side of the hemostatic connector 21 will be briefly described. First, the proximal end side of the hemostatic part 23 of the hemostatic connector 21 is inserted into the housing recess 53 of the connector 43. Next, the hemostatic part 23 is pushed to the proximal end side of the accommodating recess 53. At this time, the protrusion 37 passes through the first passage portion 56 a of the guide passage 56. Then, after the hemostatic part 23 is pushed to the proximal end side of the housing recess 53, the connector 43 is rotated around the axis with respect to the hemostatic connector 21. Then, the protruding portion 37 enters the second passage portion 56 b of the guide passage 56. Thereby, the projection part 37 will be in the state engaged with the 2nd channel
  • the connector 43 of the dilator 12 is connected to the proximal end side of the hemostatic connector 21.
  • the connector 43 is connected to the proximal end side of the guiding catheter 11 via the hemostatic connector 21.
  • the dilator 12 is integrated with the guiding catheter 11, and the guiding catheter assembly 10 including the guiding catheter 11 and the dilator 12 is configured.
  • the guiding catheter assembly 10 is provided with an adjustment function for adjusting the length of the protruding portion 71 of the dilator shaft 41 in the dilator 12.
  • the adjustment function will be described with reference to FIG.
  • FIG. 7 is a front view showing how the length of the protrusion 71 is adjusted.
  • the connector 43 of the dilator 12 can be displaced in the axial direction with respect to the dilator shaft 41 in the released state (the state shown in FIG. 5B) in which the fixing to the dilator shaft 41 is released.
  • the guiding catheter 11 connected to the connector 43 via the hemostatic connector 21
  • the length of the protruding portion 71 protruding from the distal end of the guiding catheter 11 can be adjusted by the relative displacement between the guiding catheter 11 and the dilator shaft 41.
  • the connector 43 is displaced to the proximal end side with respect to the dilator shaft 41, so that the length of the protruding portion 71 is increased.
  • the connector 43 is displaced toward the tip side with respect to the dilator shaft 41, so that the length of the protruding portion 71 is shortened.
  • the length of the protrusion 71 can be adjusted.
  • the connector 43 is fixed to the dilator shaft 41 to be in a fixed state (the state shown in FIG. 5A).
  • FIG. 8 is an explanatory diagram of work contents.
  • the guiding catheter assembly 10 will be described using an example in which the guiding catheter assembly 10 is introduced to the treatment target site in the peripheral blood vessel of the leg.
  • an example is used in which the guiding catheter assembly 10 is introduced into the blood vessel from the thigh of the leg opposite to the leg to be treated.
  • a hole 75 for introduction leading from the body surface into the blood vessel 74 is formed in advance in the patient's thigh.
  • a guide wire G is introduced into the blood vessel 74 through the hole 75 in advance. The distal end portion of the guide wire G reaches the treatment target site in the peripheral blood vessel.
  • the guide wire G is inserted into the lumen 41a of the dilator shaft 41. With the guide wire G inserted through the dilator shaft 41, the guiding catheter assembly 10 is introduced into the blood vessel 74 through the hole 75. At this time, the length L1 of the protrusion 71 is shortened. The length L1 of the protrusion 71 is set to about 5 mm to 10 mm, for example.
  • the guiding catheter assembly 10 is introduced into the blood vessel 74 while expanding the hole 75 by the protrusion 71. In this case, since the length of the protrusion 71 is short, the rigidity on the distal end side of the guiding catheter assembly 10 is high. Therefore, when the guiding catheter assembly 10 is introduced into the blood vessel 74, it is possible to suppress the occurrence of problems such as kinking of the distal end side. In this way, the guiding operation of the guiding catheter assembly 10 can be facilitated.
  • the guiding catheter assembly 10 when the guiding catheter assembly 10 is introduced into the peripheral blood vessel, the guiding catheter assembly 10 may pass through the bent blood vessel 77.
  • the length of the protrusion 71 is set to a length L2 longer than L1.
  • the length L2 is, for example, about 5 mm to 200 mm. Since the protrusion 71 is long, the flexibility on the distal end side of the guiding catheter assembly 10 can be enhanced. Therefore, the followability to the bent blood vessel 77 can be improved. Therefore, it is possible to facilitate the operation of passing the bent blood vessel 77.
  • the guiding catheter assembly 10 when the guiding catheter assembly 10 is introduced into the peripheral blood vessel, the guiding catheter assembly 10 may pass through the stenotic region 81.
  • a lesioned part 79 is fixed to the inner wall of the blood vessel 78, and a stenotic region 81 is generated in the blood vessel 78 by the lesioned part 79.
  • the length of the protrusion 71 is set to a length L3 shorter than L2.
  • the length L3 is, for example, the same length as the length L1.
  • the rigidity of the distal end side of the guiding catheter assembly 10 can be increased. Therefore, the pushing force when pushing the guiding catheter assembly 10 into the stenosis part 81 can be suitably transmitted to the tip of the protrusion 71. Therefore, it is possible to facilitate the operation of passing the stenosis region 81.
  • the guiding catheter assembly 10 when the guiding catheter assembly 10 is introduced into the blood vessel 74 through the hole 75, when passing through the bent blood vessel 77, when passing through the stenosis site 81, etc.
  • the length of the protrusion 71 can be adjusted according to the introduction situation. Therefore, the flexibility (or rigidity) on the distal end side of the guiding catheter assembly 10 can be adjusted according to each introduction situation. As a result, the operability when introducing the guiding catheter assembly 10 into a peripheral blood vessel can be enhanced.
  • the connector 43 is removed from the hemostatic connector 21 and the dilator 12 is removed from the guiding catheter 11. Thereafter, a device such as a balloon catheter is introduced into the treatment target site in the peripheral blood vessel through the inside of the guiding catheter 11 to treat the site.
  • the connector 43 In the released state (fixed released state) of the connector 43, the connector 43 can be displaced in the axial direction with respect to the dilator shaft 41. In this case, the length of the protrusion 71 can be adjusted by displacing the connector 43 in the axial direction. Therefore, as compared with the case where the connector 43 is provided with a displacement mechanism for displacing the connection portion connected to the hemostatic connector 21 in the axial direction, the configuration can be simplified.
  • An internal passage 65 for inserting the dilator shaft 41 through the connector 43 is provided.
  • the connector 43 can be displaced in the axial direction along the dilator shaft 41 inserted through the internal passage 65. In this case, since the user can guide the connector 43 along the dilator shaft 41, the user can easily perform an operation of adjusting the length of the protruding portion 71 by moving the connector 43.
  • the internal passage 65 has a hole shape, the connector 43 is not detached from the dilator shaft 41 when the connector 43 is moved in the axial direction along the dilator shaft 41. Therefore, the operation of adjusting the length of the protruding portion 71 can be further facilitated.
  • the connector 43 includes an O-ring 69 and a pair of bodies 51 and 52.
  • the O-ring is provided so as to surround the outer periphery of the dilator shaft 41.
  • the pair of bodies 51 and 52 are configured to be displaceable in the axial direction between the compression position and the compression release position.
  • the compression position is a position where the pair of bodies 51 and 52 compress the O-ring 69 in the axial direction.
  • the compression release position is a position where the pair of bodies 51 and 52 are not compressing the O-ring 69.
  • the compression release position is also a position where the pair of bodies 51 and 52 are not acting on the O-ring 69.
  • the compression of the O-ring 69 causes the inner peripheral portion of the O-ring 69 to be pressed against the outer peripheral surface of the dilator shaft 41 so that the connector 43 is fixed.
  • the pair of bodies 51 and 52 are in the compression release position, the pressing of the inner peripheral portion of the O-ring 69 against the outer peripheral surface of the dilator shaft 41 is released, and the connector 43 is released.
  • the dilator shaft 41 is not easily crushed. Therefore, it is possible to fix the connector 43 to the dilator shaft 41 while suppressing a decrease in the insertability of the guide wire G inserted into the lumen 41a.
  • the connector 43 since the connector 43 includes an O-ring 69 (elastic member) disposed on the outer periphery of the dilator shaft 41, the connector 43 and thus the guiding catheter 11 are not intended along the dilator shaft 41 when the connector 43 is released. It is possible to prevent sliding.
  • O-ring 69 elastic member
  • the present invention is not limited to the above embodiment, and may be implemented as follows, for example.
  • the connector 43 is configured to be displaceable (movable) in the axial direction with respect to the dilator shaft 41.
  • the connector 43 may be fixed to the dilator shaft 41.
  • the connector may have a fixed portion fixed to the dilator shaft 41 and a movable portion that can be displaced in the axial direction with respect to the fixed portion.
  • the movable portion may be configured to be connected to the proximal end side of the guiding catheter 11 (via the hemostatic connector 21).
  • the movable part corresponds to the connection part.
  • the movable catheter is displaced in the axial direction with respect to the dilator shaft 41, so that the guiding catheter 11 connected to the movable portion can be displaced in the axial direction with respect to the dilator shaft 41.
  • the connector 43 is provided with a hole-like internal passage 65 as an insertion portion through which the dilator shaft 41 is inserted.
  • the insertion portion does not necessarily have a hole shape, and may have a groove shape, for example. Even in that case, since the connector 43 can move in the axial direction along the dilator shaft 41 inserted through the insertion portion, the operation of adjusting the length of the protruding portion 71 by moving the connector 43 can be facilitated. . Further, the insertion portion may not be provided in the connector 43.
  • the pair of bodies 51 and 52 compress the O-ring 69 in the axial direction.
  • the connector 43 is fixed.
  • the compression to the O-ring 69 by the pair of bodies 51 and 52 is released, and the inner peripheral portion of the O-ring 69 does not press the outer peripheral surface of the dilator shaft 41, so that the connector 43 is in the released state (fixed released state).
  • the configuration for switching the connector 43 between the fixed state and the released state is not necessarily limited to this.
  • the connector may have a pair of clamping portions that clamp the dilator shaft 41.
  • the connector 43 may be fixed by holding the dilator shaft 41 by the pair of holding portions. In this case, a configuration is considered in which the connector 43 is released by the pair of clamping portions not clamping the dilator shaft 41.
  • the O-ring 69 is used as the annular elastic member.
  • an elastic member other than the O-ring may be used as the annular elastic member.
  • the guide wire G is introduced in advance to the treatment target site of the peripheral blood vessel, and the guiding catheter assembly 10 is moved into the blood vessel along the introduced guide wire G. Introduced. However, in some cases, the guide wire G and the guiding catheter assembly 10 may be alternately introduced toward the treatment target site. In this case, both guide wires G are alternately introduced while leading the guiding catheter assembly 10.
  • the guide wire G is first introduced to a predetermined location in the blood vessel, and then the guiding catheter assembly 10 is introduced until the distal end of the protruding portion 71 reaches the vicinity of the distal end of the guide wire G. . Then, the guide wire G is introduced again toward the back side in the blood vessel, and then the guiding catheter assembly 10 is introduced again until the distal end reaches the distal end of the guide wire G. Then, the guiding catheter assembly 10 is introduced to the treatment target site while repeating such alternate introduction work.
  • the guide wire G when the guide wire G is introduced to the back side, if the rigidity on the distal end side of the guiding catheter assembly 10 is reduced, the guide wire G is pushed to the back side.
  • the distal end side of the guiding catheter assembly 10 may be deformed and it may be difficult to suitably introduce the guide wire G.
  • the rigidity of the guiding catheter assembly 10 on the distal end side can be increased. Therefore, the guide wire G can be suitably introduced into the back side while suppressing the deformation on the tip side.
  • the catheter shaft 14 of the guiding catheter 11 and the dilator shaft 41 of the dilator 12 do not necessarily have a linear shape.
  • the tip side of at least one of the shafts 14 and 41 may have a bent portion (bent portion). In that case, it is possible to improve the followability to the bent blood vessel.
  • the hardness of the tip side portion of the dilator shaft 41 may change in the axial direction.
  • the hardness of the distal end side portion of the dilator shaft 41 may increase stepwise or continuously from the distal end side toward the proximal end side. In this case, it is possible to improve force transmission and kink resistance at the protrusion 71 of the dilator shaft 41.
  • the range in which the hardness changes is, for example, a range from the tip of the dilator shaft 41 to a position on the base end side of 200 mm.
  • the range in which the hardness changes is divided into three regions in the axial direction, and the hardness of the three regions is increased stepwise from the distal end side toward the proximal end side.
  • the three regions may be constituted by tubes having different hardnesses.
  • the three regions include a distal end region, an intermediate region, and a proximal end region.
  • the distal end side region is a range from the distal end of the dilator shaft 41 to a position on the proximal end side of 80 mm.
  • the intermediate region is a range from the proximal end of the distal end side region to a position 60 mm proximal end.
  • the proximal end region is a range from the proximal end of the intermediate region to a position 60 mm proximal end.
  • the connector 43 is connected to the proximal end side of the guiding catheter 11 via the hemostatic connector 21 (connection member).
  • the connector 43 may be connected to the guiding catheter 11 via a connecting member other than the hemostatic connector 21 (for example, a connector having no hemostatic function).
  • the connector 43 may be connected to the proximal end side of the guiding catheter 11 via a plurality of connection members.
  • the connector 43 may be directly connected to the proximal end side of the guiding catheter 11 without using a connection member.
  • the dilator of the present invention is used for a guiding catheter for peripheral blood vessels.
  • the dilator of the present invention may be used for a guiding catheter used for other blood vessels such as a heart blood vessel.
  • the dilator of the present invention is not necessarily used for a guiding catheter, and may be used for a sheath introducer, for example.
  • the connector 43 includes the first body 51 and the second body 52.
  • the connector does not have to have a pair of bodies.
  • the connector may be composed of one body.
  • the connector 43 has the O-ring 69.
  • the connector 43 may not have the O-ring 69.
  • the connector may include a cylindrical first member formed of an elastically deformable member and a second member that covers at least a part of the first member.
  • the dilator shaft 41 is inserted through each of the first member and the second member.
  • the connector should just be comprised so that a 1st member may be crimped
  • the first member and the second member may be configured to be fitted to each other.
  • the 1st member should just be compressed by the 2nd member in the state where the 1st member and the 2nd member were fitted.
  • the first member corresponds to the connection portion.
  • SYMBOLS 10 Guiding catheter assembly as a catheter assembly, 11 ... Guiding catheter as a catheter, 12 ... Dilator, 21 ... Hemostatic connector, 41 ... Dilator shaft, 41 ... Lumen as lumen, 43 ... Connector, 51 ... A first body as a connection part, 52 ... a second body, 65 ... an internal passage as an insertion part, 69 ... an O-ring as an elastic member, 71 ... a protruding part.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biophysics (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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

　L'invention concerne un ensemble cathéter de guidage 10 muni d'un cathéter de guidage 11 et un dilatateur 12. Le dilatateur 12 est pourvu d'une tige de dilatateur 41 comprenant une partie saillante 71 faisant saillie depuis la pointe du cathéter de guidage 11 lorsqu'elle est introduite dans le cathéter de guidage 11, et un connecteur 43 relié au côté extrémité proximale du cathéter de guidage 11. Le connecteur 43 est conçu de façon à être commutable entre un état fixe dans lequel le connecteur 43 est fixe par rapport à la tige de dilatateur 41, et un état relâché dans lequel la fixation est relâchée. Le connecteur 43 est conçu de manière à être apte à changer de position dans la direction axiale par rapport à la tige de dilatateur 41 lorsqu'il est dans l'état relâché.
PCT/JP2015/077665 2014-10-07 2015-09-30 Dilatateur et ensemble cathéter Ceased WO2016056439A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2014206233A JP6346064B2 (ja) 2014-10-07 2014-10-07 ダイレータ及びカテーテル組立体
JP2014-206233 2014-10-07

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WO2016056439A1 true WO2016056439A1 (fr) 2016-04-14

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PCT/JP2015/077665 Ceased WO2016056439A1 (fr) 2014-10-07 2015-09-30 Dilatateur et ensemble cathéter

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JP (1) JP6346064B2 (fr)
WO (1) WO2016056439A1 (fr)

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* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP7723536B2 (ja) * 2021-08-27 2025-08-14 テルモ株式会社 シースおよび医療用組立体

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6284441U (fr) * 1985-11-14 1987-05-29
US20080183128A1 (en) * 2007-01-24 2008-07-31 John Morriss Methods, devices and systems for treatment and/or diagnosis of disorders of the ear, nose and throat
JP2014097103A (ja) * 2012-11-13 2014-05-29 Piolax Medical Device:Kk ガイドワイヤ保持具

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2161009A4 (fr) * 2007-05-21 2012-08-22 Kawasumi Lab Inc Dispositif de greffe d'endoprothèse à demeure, greffe d'endoprothèse et pointe de fixation
US8333787B2 (en) * 2007-12-31 2012-12-18 St. Jude Medical Puerto Rico Llc Vascular closure device having a flowable sealing material

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6284441U (fr) * 1985-11-14 1987-05-29
US20080183128A1 (en) * 2007-01-24 2008-07-31 John Morriss Methods, devices and systems for treatment and/or diagnosis of disorders of the ear, nose and throat
JP2014097103A (ja) * 2012-11-13 2014-05-29 Piolax Medical Device:Kk ガイドワイヤ保持具

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JP2016073469A (ja) 2016-05-12

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