WO2014109048A1 - Medical device for biological lumen - Google Patents

Medical device for biological lumen Download PDF

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Publication number
WO2014109048A1
WO2014109048A1 PCT/JP2013/050395 JP2013050395W WO2014109048A1 WO 2014109048 A1 WO2014109048 A1 WO 2014109048A1 JP 2013050395 W JP2013050395 W JP 2013050395W WO 2014109048 A1 WO2014109048 A1 WO 2014109048A1
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WO
WIPO (PCT)
Prior art keywords
portion
distal end
lumen
tube
medical device
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Application number
PCT/JP2013/050395
Other languages
French (fr)
Japanese (ja)
Inventor
下山真和
Original Assignee
テルモ株式会社
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Filing date
Publication date
Application filed by テルモ株式会社 filed Critical テルモ株式会社
Priority to PCT/JP2013/050395 priority Critical patent/WO2014109048A1/en
Publication of WO2014109048A1 publication Critical patent/WO2014109048A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2/962Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve
    • A61F2/966Instruments specially adapted for placement or removal of stents or stent-grafts having an outer sleeve with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/95Instruments specially adapted for placement or removal of stents or stent-grafts
    • A61F2002/9517Instruments specially adapted for placement or removal of stents or stent-grafts handle assemblies therefor

Abstract

A medical device for a biological lumen (10) comprises an outer tube body (18) which has a lumen (22) inside thereof, a blocking portion (72) which blocks the lumen (22) at a distal end of the outer tube body (18), and an inner structure (20) which has a port (80) that receives pressure from a priming liquid. The inner structure (20) is provided with an elastic member (86) proximal to the port (80). The elastic member (86) elastically deforms when the port (80) receives pressure from the priming liquid and causes the blocking portion (72) to distally move relative to the outer tube body (18).

Description

Medical device for living body lumen

The present invention relates to a medical device for living body lumen that delivers the inside of a living body lumen to perform diagnosis, treatment, etc. on a lesion in the living body lumen.

Conventionally, for a lesion (stenosis or occlusion) in a living body lumen such as a blood vessel, bile duct, trachea, esophagus, urethra, etc., a medical device for living body lumen is inserted into the living body lumen and diagnosed. Intervention techniques for treatment and treatment are taken.

For example, the applicant of the present invention has previously proposed a medical device for living body lumen in which a stent is placed in a lesion as disclosed in International Publication No. 2011-122444. This device includes an inner tube on which a stent is placed on the distal end side, an outer tube having a lumen that accommodates the inner tube, and a blockage that is provided at the distal end of the inner tube and closes the distal end opening that communicates with the lumen. And an operation unit for moving the outer tube relative to the inner tube. After delivering the distal end of the device (the distal end side of the occlusion part, outer tube and inner tube) to the lesioned part, the operator operates the operation part to expose the stent by retracting the outer tube to the proximal end side. And place in the lesion.

By the way, the device used in the living body lumen as described above fills the outer tube with a priming solution (for example, physiological saline) before use in order to prevent air from entering the living body (that is, in the outer tube). Priming is performed. In priming, a priming solution is injected from the proximal end side of the device to circulate through the lumen, and is discharged from the distal end opening of the outer tube.

Therefore, prior to priming, a pre-operation is performed in which the outer tube is moved relative to the inner tube toward the proximal end to open the distal end opening from the closed portion to create a priming liquid flow path (exit). However, in practice, the priming may not be smoothly performed because the surgeon forgets the preliminary operation and distributes the priming liquid. In addition, the surgeon unexpectedly moves the operating portion during priming to close the tip opening, or after priming (when inserted into a living body lumen), forgetting to close the tip opening due to the blocking portion Also occurs.

The present invention has been made in view of the above-described circumstances, and with a simple configuration, the lumen of the outer tube is normally closed by the blocking portion, and the lumen of the outer tube is opened from the blocking portion at the time of priming. An object of the present invention is to provide a medical device for living body lumen that can smoothly distribute a priming solution and that can perform priming efficiently and satisfactorily.

In order to achieve the above object, a medical device for living body lumen according to the present invention is capable of delivering in a living body lumen, and has an outer tube having a lumen extending in the axial direction therein, and the lumen. And an inner structure having a blocking portion that closes the lumen at the tip of the outer tube, and a pressure receiving portion that receives the pressure of the fluid flowing in the lumen. The inner structure includes an elastic portion in the middle of the axial direction and at a base end side of the pressure receiving portion, and the elastic portion is elastically deformed when the pressure receiving portion receives the pressure of the fluid, and the outer tube And relatively moving the closed portion forward.

According to the above, the medical device for living body lumen is supplied to the lumen of the outer tube at the time of priming by a simple configuration in which the elastic portion is provided at a position midway in the axial direction of the inner structure and at the base end side of the pressure receiving portion. The fluid (priming liquid) can be easily circulated. That is, when the pressure receiving portion receives the pressure of the priming liquid flowing in the lumen, the elastic portion is elastically deformed to advance the closing portion toward the distal end relative to the outer tube, so that the lumen blocked by the closing portion Is opened, and the priming liquid can be discharged from the tip. Therefore, this device eliminates the prior operation required from the operator at the time of priming, and avoids inconveniences such as inadvertently blocking the lumen or performing a procedure with the lumen open. Priming can be performed efficiently and satisfactorily.

In this case, the inner structure includes a distal end member having the blocking portion and the pressure receiving portion, and a proximal end member that supports the distal end member on a proximal end side of the distal end member, and the elastic portion includes It is preferable to be provided at the proximal end side of the distal end member, the distal end side of the proximal end member, or between the distal end member and the proximal end member.

Thus, the elastic portion is provided at the proximal end side of the distal end member, the distal end side of the proximal end member, or between the distal end member and the proximal end member, so that at least the closed portion of the distal end member is based on the elastic deformation of the elastic portion. Can be moved forward to the tip side with certainty.

Further, the distal end member has a guide wire lumen into which a guide wire can be inserted, and includes a port that exposes the guide wire to the outside of the intermediate position in the axial direction of the outer tube by being bent at the proximal end side, The port may constitute the pressure receiving portion.

That is, the medical device for living body lumens can be easily primed even if the distal end member having the guide wire lumen is configured to be a rapid exchange type in which the guide wire is exposed to the outside in the middle of the axial direction of the outer tube. Can do. In this case, since the port functions as a pressure receiving portion, it is not necessary to provide another pressure receiving portion, and a simpler configuration can be achieved.

Further, it is preferable that the distal end member is supported by a support body that is fixed to the proximal end member and extends in the distal end direction, and the port is disposed in the vicinity of the proximal end member.

As described above, when the port is disposed in the vicinity of the proximal end member, the medical device for living body lumen can easily cause the priming liquid to collide with the port when the priming liquid is discharged from the proximal end member. Can do. Thereby, the port which is a pressure receiving part can be pressed more reliably, and the elastic deformation of the elastic part can be promoted.

Here, the base end member may be a tube having a flow passage through which the fluid can flow, and the elastic portion may be integrally formed at a tip end of the base end member.

As described above, since the elastic portion is integrally formed at the distal end of the base end member, the medical device for living body lumen has a smaller number of parts of the inner structure and a simpler configuration.

Further, it is preferable that the elastic portion has a coil portion that is extendable in the axial direction by cutting the base end member in a spiral shape.

Thus, the coil portion (elastic portion) can be easily formed by cutting the base end member in a spiral shape. And the coil part shape | molded in this way can be elastically deformed smoothly along an axial direction, and can advance the obstruction | occlusion part to the front end side.

Alternatively, the elastic portion may be made of elastic rubber that displaces the tip member relative to the base end member.

Thus, even if the elastic portion is made of elastic rubber that displaces the distal end member relative to the proximal end member, the elastic rubber elastically supports the distal end member, thereby smoothly elastically deforming along the axial direction. Thus, the closing portion can be advanced to the tip side.

The medical device for living body lumen described above may further include a stent housed in an expandable state between the outer tube and the inner structure.

Thus, by providing the stent housed in an expandable state between the outer tube and the inner structure, a stent delivery catheter having the above-described effects can be obtained.

It is a side view which abbreviate | omits and shows the whole structure of the medical device for biological lumens concerning one Embodiment of this invention. FIG. 2 is an exploded perspective view of the handle of FIG. 1. 3A is a side view showing the distal end side of the inner structure in FIG. 1, and FIG. 3B is a side view showing an elastically deformed state of the coil portion in FIG. 3A. It is side surface sectional drawing of the front end side of the medical device for biological lumens of FIG. 5A is a side view of the inner proximal tube of FIG. 1, FIG. 5B is a perspective view of the inner proximal tube of FIG. 1, and FIG. 5C is a side view showing an elastic deformation state of the coil portion of FIG. 5A. FIG. 5D is a perspective view showing an elastically deformed state of the coil portion of FIG. 5B. FIG. 6A is a side view showing a first configuration example of the elastic portion, and FIG. 6B is a side view showing a second configuration example of the elastic portion. 7A is a side view showing a third configuration example of the elastic portion, FIG. 7B is a side sectional view of the elastic portion in FIG. 7A, and FIG. 7C is a side view showing an elastic deformation state of the elastic portion in FIG. 7B. It is sectional drawing. 8A is a first explanatory diagram illustrating the operation of the medical device for biological lumen of FIG. 1, and FIG. 8B is a second explanatory diagram illustrating the operation of the medical device for biological lumen of FIG. These are 3rd explanatory drawings which show the effect | action of the medical device for biological lumens of FIG. FIG. 9A is a side sectional view schematically showing the configuration of the medical device for living body lumen according to the first modification, and FIG. 9B is a side sectional view showing an elastic deformation state of the elastic member of FIG. 9A. FIG. 10A is a side cross-sectional view schematically showing a configuration of a medical device for living body lumen according to a second modification, and FIG. 10B is a side cross-sectional view showing an elastically deformed state of the coil portion of FIG. 10A.

Hereinafter, preferred embodiments of the medical device for living body lumen according to the present invention will be described in detail with reference to the accompanying drawings.

The medical device 10 for living body lumen according to the present embodiment (hereinafter also simply referred to as device 10) is a stent 12 for the treatment of a lesion portion generated in a living body lumen such as a blood vessel, a bile duct, a trachea, an esophagus, and a urethra. It is configured as a catheter for stent delivery that delivers and indwelles to the lesion. In the following description, the left side (stent 12 side) of the device 10 in FIG. 1 is referred to as the “front end” side, and the right side (handle 16 side) of the device 10 is referred to as the “base end (rear end)” side.

As shown in FIG. 1, the device 10 includes a catheter portion 14 inserted into a living body lumen, a handle 16 (for connecting the catheter portion 14 on the proximal side, connected to the proximal end side of the catheter portion 14. Operation section).

The catheter portion 14 has a long outer tube body 18 (outer tube) that houses the stent 12 on the distal end side, and the stent 12 is mounted (mounted) closer to the distal end and is housed inside the outer tube body 18 together with the stent 12. An inner structure 20 to be formed. The outer tube body 18 can move relative to the inner structure 20 along the axial direction of the catheter portion 14.

The outer tube body 18 is a flexible tubular body, and has a lumen 22 (inner lumen: see FIG. 4) for accommodating the inner structure 20 so as to be able to move forward and backward. The outer tube body 18 includes an outer distal tube 24 that houses the stent 12, an outer intermediate tube 26 that is coupled to the proximal end side of the outer distal tube 24, and an outer base that is coupled to the proximal end side of the outer intermediate tube 26. And an end tube 28. The lumen 22 has an inner diameter that varies depending on the part, and is formed through the outer distal tube 24, the outer intermediate tube 26, and the outer proximal tube 28 in the axial direction.

The outer tip tube 24 is formed such that the inner diameter of the lumen 22 is constant along the axial direction, and the stent 12 can be accommodated with a predetermined contraction diameter. A distal end opening 24 a communicating with the lumen 22 is formed at the distal end of the outer distal tube 24. Therefore, when the outer tube body 18 is moved relative to the inner structure 20, the stent 12 can be released from the distal end opening 24 a of the outer distal tube 24 and expanded.

The outer intermediate tube 26 is formed slightly thicker than the outer distal tube 24 and is fixed to the outer peripheral surface of the proximal end of the outer distal tube 24. Therefore, the inner diameter of the lumen 22 in the outer intermediate tube 26 is larger than the inner diameter of the outer tip tube 24. Further, one side portion near the tip of the outer intermediate tube 26 is a bulging portion 30 that bulges radially outward. The inner diameter of the bulging portion 30 is larger than the inner diameter on the proximal end side of the outer intermediate tube 26. A guide wire lead-out hole 34 that exposes the guide wire 32 previously introduced into the living body lumen to the outside is formed at a side portion of the bulging portion 30 (that is, an intermediate position in the axial direction of the outer tube body 18). (See FIG. 4). Further, the base end side of the outer intermediate tube 26 with respect to the bulging portion 30 is formed over a predetermined length according to the relationship with the coil portion 88 described later.

The outer proximal tube 28 constitutes the trunk portion (main length portion) of the catheter portion 14. The outer proximal tube 28 is formed slightly thinner than the outer intermediate tube 26, and the distal end side thereof is connected to the proximal inner peripheral surface of the outer intermediate tube 26. The proximal end side of the outer proximal tube 28 is inserted and connected into the handle 16.

The outer tube body 18 (the outer distal tube 24, the outer intermediate tube 26, and the outer proximal tube 28) is formed by appropriately considering physical properties such as pushability, followability, and kink resistance with respect to a living body lumen. The constituent material of the outer tube body 18 is not particularly limited. For example, polyolefin such as polyethylene and polypropylene, polyester such as polyamide and polyethylene terephthalate, fluorine-based polymer such as PTFE and ETFE, polyamide elastomer, polyester elastomer and the like These include thermoplastic elastomers, stainless steel, superelastic metals, and the like.

On the other hand, the handle 16 for connecting and supporting the outer tube body 18 and the inner structure 20 is housed in the housing 36, the rack member 38 and the rotation operation unit 40 housed in an intermediate portion of the housing 36, and the base end portion of the housing 36. Connector 42 is provided.

As shown in FIGS. 1 and 2, the housing 36 is formed in an elongated shape with an appropriate size so that the operator can easily hold it with one hand, and its central portion in the longitudinal direction is rounded and thick. Has been. A distal end nozzle 44 that supports the outer proximal end tube 28 so as to be slidable in the axial direction is attached to the distal end portion of the housing 36 via a cap 46. In other words, the tip nozzle 44 is fixed to the housing 36 by the cap 46 being screwed into the tip of the housing 36 while being attached to the tip of the housing 36.

The housing 36 is composed of a first housing 48 and a second housing 50 which are divided into two from the approximate center in the thickness direction. The first housing 48 includes a pair of first disposition grooves 48a and 48b that support the rack member 38 so as to be movable in the longitudinal direction, and a rotation operation portion that is substantially the center in the longitudinal direction of the first housing 48. A first support portion 48c that supports the housing 40 and a first connector mounting portion 48d that forms a base end portion of the first housing 48 and that is mounted with the connector 42 are formed.

The pair of first disposition grooves 48a and 48b are formed on the distal end side and the proximal end side of the first housing 48 with the first support portion 48c interposed therebetween. The first support portion 48 c is formed to have a larger outer shape than other portions of the first housing 48 and has a space in which the rotation operation portion 40 can be accommodated. The first support portion 48c is formed with an opening 48e for exposing a part of the rotation operation portion 40 to the outside.

The second housing 50 has a shape corresponding to the first housing 48. Therefore, the second housing 50 includes a pair of second disposition grooves 50a and 50b that support the rack member 38 so as to be movable along the longitudinal direction, and a substantially central portion in the longitudinal direction of the second housing 50. A second support portion 50c that supports the operation portion 40 and a second connector mounting portion 50d that forms the base end portion of the second housing 50 and that is mounted with the connector 42 are formed.

That is, in the assembled state of the first housing 48 and the second housing 50, the housing 36 forms one receiving space by the first disposition groove 48a and the second disposition groove 50a on the distal end side, and the proximal end side The first disposing groove 48b and the second disposing groove 50b form one housing space. Then, by accommodating the rack member 38 in these accommodation spaces, the rack member 38 is guided to move along the longitudinal direction of the housing 36.

In addition, the housing 36 holds the connector 42 in the housing 36 by holding the connector 42 between the first connector mounting portion 48d and the second connector mounting portion 50d in the assembled state of the first housing 48 and the second housing 50. Hold and hold.

The rack member 38 converts the rotational motion of the rotational operation unit 40 into a linear motion, and includes a rack body 52 having rack teeth 52 a and a fixing portion that fixes the rack body 52 to the proximal end portion of the outer proximal tube 28. 54. The outer proximal tube 28 is fixed to the rack member 38 and operates together with the rack member 38.

The rotation operation unit 40 is rotatably accommodated in an accommodation space constituted by the first support part 48c and the second support part 50c. The rotation operation unit 40 includes a roller 56, a first gear 56 a fixed to a plane of the roller 56 facing the first housing 48, a first rotation shaft 56 b provided on the first gear 56 a, Of these, a second gear 56c (see FIG. 1) fixed to a plane facing the second housing 50 and a second rotating shaft 56d provided on the second gear 56c are included.

The axes of the roller 56, the first gear 56a, the first rotating shaft 56b, the second gear 56c, and the second rotating shaft 56d are set coaxially. The roller 56 is accommodated in the first support portion 48c so that a part of the roller 56 is exposed to the outside from the opening 48e of the first housing 48, and can be operated manually. On the outer peripheral surface of the roller 56, unevenness for preventing slipping is formed.

The first gear 56a is formed with a smaller diameter than the roller 56, and comes into contact with a thin plate-like notch portion 58 that can be elastically deformed. The contact between the first gear 56a and the notch portion 58 allows the roller 56 to rotate intermittently and gives the operator (operator) a feeling of operation when the roller 56 is rotated. Further, the rotation operation and the rotation angle of the roller 56 can be confirmed from the sound generated when the notch portion 58 and the first gear 56a are engaged. The first rotating shaft 56b protruding from the first gear 56a is inserted into a hole 60 formed in the wall portion of the first support portion 48c.

The second gear 56c is formed with a smaller diameter than the first gear 56a, and meshes with the rack teeth 52a of the rack body 52. The second rotating shaft 56d protruding from the second gear 56c is inserted into a bearing portion 62 provided on the wall surface of the second support portion 50c. The rotation operation unit 40 is assembled so as to be rotatable with respect to the housing 36 and mesh with the rack member 38, and is exposed from the opening 48e.

The handle 16 assembled by the above configuration causes the rack member 38 to linearly move when the operator rotates the rotation operation unit 40. Then, the outer proximal end tube 28 fixed to the rack member 38 is displaced in the longitudinal direction of the handle 16. Accordingly, the entire outer tube body 18 moves back and forth in the axial direction (the distal end and the proximal end) of the catheter portion 14 based on the rotation operation of the operator. The inner structure 20 is fixed to the handle 16 with respect to the outer tube body 18, and the outer tube body 18 is moved relative to the inner structure 20.

As shown in FIG. 1 and FIG. 3A, the inner structure 20 is formed so that its entire length is longer than the entire length of the outer tube body 18, and the inner structure 20 is formed on the lumen 22 so as to be exposed from the distal end and the base end of the outer tube body 18. Be contained. The inner structure 20 includes an inner distal tube 64 (distal member), a pusher wire 66 (support), and an inner proximal tube 68 (proximal member) in order from the distal end to the proximal end.

The inner tip tube 64 is a flexible tubular body and is slightly thinner than the outer tip tube 24. As shown in FIGS. 3A and 4, a guide wire lumen 70 through which the guide wire 32 is inserted is formed through the inner distal end tube 64 along the axial direction. The distal end portion of the inner distal tube 64 protrudes from the distal opening 24 a of the outer distal tube 24, and a distal outlet port 70 a that communicates with the guide wire lumen 70 is formed on the distal end surface. In addition, an annular blocking portion 72 that blocks the tip opening 24 a of the outer tube body 18 is provided on the outer peripheral surface on the tip side of the inner tip tube 64.

The closing portion 72 has a distal end portion that tapers toward the distal end side, an intermediate portion having a constant outer diameter, and a proximal end portion that tapers toward the proximal end side. The outer diameter of the intermediate part of the blocking part 72 is larger than the hole diameter of the distal end opening part 24 a of the outer tube body 18. Therefore, the proximal end portion of the closing portion 72 defines the movement limit on the distal end side in the forward / backward movement of the outer tube body 18. The closing portion 72 can reliably close (seal) the distal end opening 24 a of the outer tube body 18 by contacting the distal end of the outer tube body 18.

Then, the stent 12 is placed on the outer peripheral surface of the inner distal end tube 64 that is separated from the blocking portion 72 by a predetermined distance. The stent 12 has a self-expanding function, and is expanded (restricted, expandable) in a space (lumen 22) formed between the inner tip tube 64 and the outer tube body 18 so that expansion is restricted. State). The stent 12 automatically expands when the outer tube body 18 retracts proximally relative to the inner structure 20 and is released from the expansion restriction by the outer tube body 18. Note that the outer peripheral surface of the outer tube body 18 may be provided with a contrast marker 74 on the outer peripheral surface that overlaps with the accommodation position of the stent 12.

The distal end and the proximal end of the stent 12 are formed with a distal-side reduced diameter portion 12a and a proximal-side reduced diameter portion 12b that are slightly smaller in diameter than the body portion, and the distal-end reduced diameter portion 12a and the proximal-side reduced diameter are formed. Contrast markers 75 and 76 are provided in the portion 12b. The stent 12 has a configuration in which a plurality of skeletons formed in a ring shape or Z shape of a wire made of a superelastic alloy such as a Ti—Ni alloy are arranged in the axial direction, or a wire made of a superelastic alloy or the like is knitted in a mesh shape. A configuration can be employed.

A pair of stent locking portions 78 and 79 for restricting movement of the stent 12 in the axial direction are provided on the outer peripheral surface of the inner distal end tube 64 on which the stent 12 is placed. The pair of stent locking portions 78 and 79 are spaced apart from each other at the same interval as the axial length of the proximal-side reduced diameter portion 12b, and annular projections 78a and 79a are provided before and after the proximal-side reduced diameter portion 12b. It is the structure which pinches | interposes. These convex portions 78a and 79a contact the proximal-side reduced diameter portion 12b during relative movement of the outer tube body 18 with respect to the inner structure 20, thereby suppressing displacement of the stent 12 in the axial direction.

Returning to FIG. 1, the inner distal end tube 64 extends to the distal end portion (the bulging portion 30) of the outer intermediate tube 26, and its proximal end portion is gently curved toward the side wall of the bulging portion 30. . Therefore, the guide wire lumen 70 is also curved so as to be inclined, and communicates with a proximal end outlet 70 b formed on the proximal end surface of the port 80. That is, the proximal end side of the inner distal end tube 64 is configured as a port 80 that guides the guide wire 32 in an oblique direction.

Further, the guide wire lead-out hole 34 formed in the bulging portion 30 of the outer intermediate tube 26 (that is, the midway position in the axial direction of the outer tube body 18) corresponds to the formation position (projecting direction) of the port 80, and the guide wire 32 is exposed to the outside. That is, the device 10 according to the present embodiment is a so-called rapid exchange type catheter configured to guide the delivery of the device 10 by inserting the guide wire 32 only in the installation range of the inner distal end tube 64.

A pusher wire 66 is connected to the proximal end side of the inner distal tube 64 from the placement position of the stent 12. The inner tip tube 64 and the pusher wire 66 are firmly fixed by a heat shrink tube 82 wound around the outer peripheral surface of the inner tip tube 64.

The pusher wire 66 is made of a material that can be elastically deformed but has a relatively high rigidity (for example, a superelastic alloy, a shape memory alloy, stainless steel, etc.) so as to exhibit a straight line shape. The pusher wire 66 supports the inner distal end tube 64 in a long range and extends from the port 80 to the proximal end direction by a predetermined length and is connected to the inner proximal end tube 68. Accordingly, the inner distal end tube 64 is stably supported (movable integrally) by the pusher wire 66, and the port 80 is always spaced apart from the inner proximal end tube 68 by a certain distance.

The inner proximal tube 68 is formed in such a length that the distal end portion is located in the outer intermediate tube 26 and the proximal end portion is positioned (connected) to the connector 42 in the handle 16. The body part (main length part) of the part 14 is comprised. A flow passage 84 through which a fluid flows is formed through the entire length of the inner proximal tube 68. Although the material which comprises the inner side front end tube 64 and the inner side proximal end tube 68 is not specifically limited, For example, the material quoted by the outer side tube body 18 can be used suitably. In particular, the inner proximal tube 68 is preferably formed of a material such as a superelastic alloy, a shape memory alloy, or stainless steel in view of the relationship with the elastic portion 86 described later.

The connector 42 (see also FIG. 2) connected to the proximal end portion of the inner proximal tube 68 has a function of guiding fluid to the flow passage 84. For example, at the time of priming, a syringe (not shown) is connected to the connector 42 to supply a priming solution such as heparinized physiological saline. As a result, the priming liquid flows along the flow path 84 toward the distal end side of the inner proximal tube 68.

The distal end region of the inner proximal tube 68 is an elastic portion 86 that can elastically expand and contract along the axial direction, as shown in FIGS. 3A, 3B, and 5A to 5C. Specifically, the elastic portion 86 is connected to the body portion 69 of the inner proximal tube 68 and is substantially elastically deformed, and the distal end displacement portion 90 is connected to the distal end of the coil portion 88 and supported by the coil portion 88. And have.

The coil portion 88 is configured by cutting the wall portion 68a of the inner proximal tube 68 in a spiral shape. That is, the cylindrical wall portion 68a is formed on the bare wall 89 wound spirally by a spiral cut process using a laser. The coil portion 88 can obtain a desired elastic force by considering the material of the bare wall 89 and appropriately setting the axial cut width of the bare wall 89 during processing. In addition, the formation method of the coil part 88 is not specifically limited, For example, you may weld the pipe and spring (elastic part 86) which were separately processed in the spiral shape to the front-end | tip part of the inner side base tube 68. FIG.

In a natural state where no stress is applied, the coil portion 88 has a cylindrical shape in which the spiral bare walls 89 are in contact with each other and are flush with the outer peripheral surface of the inner proximal tube 68 (see FIGS. 5A and 5B). 5B). Then, when stress is applied in the distal direction from the distal end displacement portion 90, the adjacent wall walls 89 extend (elastically deform) so as to be separated from each other, and the distal end displacement portion 90 is displaced (see FIGS. 5C and 5D). ).

The distal end displacement portion 90 is elastically displaceable by the coil portion 88, and a communication port 84a communicating with the flow passage 84 is formed at the distal end portion. The proximal end portion of the pusher wire 66 described above is fixed to the inner wall constituting the flow passage 84 of the distal end displacement portion 90 by welding or the like.

3A, the distal end surface of the distal end displacement portion 90 (inner proximal tube 68) is disposed at a position facing the port 80 of the inner distal tube 64. As shown in FIG. In this state, the pusher wire 66 keeps the proximal end side wall portion 80 a constituting a part of the port 80 and the distal end surface of the distal end displacement portion 90 narrow. Therefore, the fluid that has circulated through the flow passage 84 of the inner proximal tube 68 flows out from the communication port 84a, so that this fluid can be applied to the port 80.

That is, the base end side wall portion 80a of the port 80 functions as a pressure receiving portion that receives the fluid flow pressure. The inner tip tube 64 is subjected to stress (hereinafter also referred to as advance output) in the tip direction when the port 80 is pressed by the fluid. As a result, this advance output is also transmitted to the distal end displacement portion 90 via the pusher wire 66, and the elastic portion 86 is expanded by the coil portion 88 elastically deforming based on the applied advance output, The distal end displacement portion 90 is displaced in the distal direction (see FIG. 3B). The pressure receiving portion may be configured separately from the port 80. For example, as shown by a broken line in FIG. 3A, a pressure receiving member 92 may be attached to a midway position of the pusher wire 66 to receive the fluid.

The displacement of the tip displacement portion 90 causes the port 80 to move integrally in the tip direction. Here, since the bulging portion 30 of the outer intermediate tube 26 has a large inner diameter over a predetermined range in the axial direction, the forward and backward movement of the port 80 can be easily allowed. Further, the guide wire outlet hole 34 is formed as a long hole according to the movement range of the port 80. Therefore, the device 10 can smoothly displace the entire inner distal tube 64 in the distal direction when the port 80 receives a pressing force.

It should be noted that the portion of the catheter portion 14 where the elastic portion 86 is disposed may be locally different in characteristics (kinking properties, bending / curving performance) of the catheter portion 14 due to the elastic deformation being promoted by the coil portion 88. There is. Therefore, an auxiliary coil 94 (reinforcing member) that assists the characteristics of the catheter portion 14 may be provided inside the outer intermediate tube 26 as shown in FIG.

Moreover, the elastic part 86 according to the present embodiment is not limited to the above-described configuration, and can of course have various configurations. Hereinafter, some other configuration examples of the elastic portion 86 will be described.

The elastic part 86A according to the first configuration example shown in FIG. 6A has a coil part 88a in which a bare wall 89a is formed in a double spiral structure. The pair of bare walls 89a and 89a constituting the coil part 88a has a width set to about ½ of the width of the bare wall 89 according to the embodiment, and draws a parallel spiral shape to form the distal end displacement part 90 and the proximal end. The body part 69 on the side is elastically connected. Therefore, the coil portion 88a has substantially the same elastic force as that of the coil portion 88 according to the embodiment, and improves the kink property of the elastic portion 86A or suppresses the bending of the elastic portion 86A in the lateral direction. Is possible.

Further, the elastic portion 86B according to the second configuration example shown in FIG. 6B includes a coil portion 88b in which the bare wall 89b is formed in a triple helical structure. Therefore, it is possible to further improve the kink property of the elastic portion 86B, suppress the bending of the elastic portion 86B in the lateral direction, or the like.

7A to 7C, the elastic portion 86C according to the third configuration example is configured by an elastic rubber 96, and elastically connects between the pusher wire 66 and the inner proximal tube 68. The elastic rubber 96 has a wire fixing portion 96a into which the pusher wire 66 is inserted and fixed, and a tube fixing portion 96b into which the inner proximal tube 68 is inserted and fixed. The wire fixing portion 96 a is formed with a depth that allows the pusher wire 66 to be held without being detached from the distal end surface of the elastic rubber 96.

In addition, a circulation extension path 96c is formed in the elastic rubber 96 so as to be adjacent to and parallel to the wire fixing portion 96a. This flow extension path 96c is widened on the axial base end side where the wire fixing portion 96a does not exist, and constitutes a tube fixing portion 96b for fixing the inner base end tube 68. Therefore, in a state where the inner base end tube 68 is inserted into the elastic rubber 96, the flow path 84 and the flow extension path 96c communicate with each other, and the fluid flows out from the tip of the flow extension path 96c.

The elastic rubber 96 receives the advance output from the pusher wire 66 by pressing the port 80 by the outflow of fluid. As a result, the elastic rubber 96 itself elastically deforms (extends) in the distal direction, and the pusher wire 66 and the wire fixing portion 96a are displaced in the distal direction. Therefore, the same effect as that of the elastic part 86 described above can be obtained.

Further, as another configuration example of the elastic portion 86, not only the elastic portion is integrally molded or connected to the inner proximal tube 68, but also, for example, a configuration in which the elastic portion is integrally molded or connected to the inner distal tube 64 side. Or the structure which divided | segmented the pusher wire 66 and connected between them by the elastic part may be sufficient. In short, the elastic portion of the device 10 can take various configurations capable of elastically connecting the distal end side and the proximal end side at an intermediate position of the inner structure 20.

The device 10 according to the present embodiment is basically configured as described above, and the operation and effect thereof will be described below.

The device 10 according to the present embodiment is in a state where the closing portion 72 of the inner structure 20 closes the distal end opening 24a of the outer tube body 18 in an initial state (for example, a product providing state). The rotation of the rotation operation unit 40 of the handle 16 is restricted by a lock unit (not shown) so that the outer tube body 18 is not moved relative to the inner structure 20.

When using this device 10, the surgeon performs priming as described above before use (before insertion of the catheter portion 14 into the living body lumen). In the priming, a syringe (not shown) storing the priming liquid is inserted into the connector 42, and the priming liquid is injected from the syringe into the connector 42. The priming liquid supplied into the device 10 flows toward the distal end side through the flow passage 84 of the inner proximal tube 68. And as shown to FIG. 8A, it flows out into the lumen | rumen 22 of the outer side tube body 18 (outer side intermediate tube 26) from the communicating port 84a of the front-end | tip displacement part 90. FIG.

Most of the priming liquid that has flowed out of the communication port 84a goes straight through the lumen 22 and collides with the proximal end side wall 80a of the port 80. At this time, the priming liquid can be vigorously supplied to the lumen 22, and a relatively large pressing force that is pushed out in the distal direction is applied to the port 80 by the priming liquid.

The pressing force of the priming liquid applied to the inner distal tube 64 (port 80) is transmitted to the distal end displacement portion 90 of the inner proximal tube 68 via the pusher wire 66 as an advance output that moves the inner distal tube 64 in the distal direction. Is done. As a result, as shown in FIG. 8B, the bare walls 89 of the coil portion 88 are extended (elastically deformed) so as to be separated from each other, and the inner structure 20 is displaced from the distal end displacement portion 90.

That is, the inner distal tube 64 and the pusher wire 66 advance toward the distal end side integrally with the distal displacement portion 90, and the blocking portion 72 that has blocked the distal opening 24a of the outer tube body 18 is moved in the distal direction. Advance.

Thus, in the state where the inner distal end tube 64 has moved to the distal end side, a flow path for the priming liquid that communicates from the space (lumen 22) between the outer distal end tube 24 and the inner distal end tube 64 to the distal end opening 24a is formed. . For this reason, the fluid easily flows in the axial direction. A part of the priming liquid that bypasses the port 80 or the priming liquid that has collided with the port 80 also moves in the distal direction in the space along the flow path, so that the lumen 22 is discharged while the air is discharged from the lumen 22. The inside is filled with the priming liquid, and discharged from the tip opening 24a to the outside. A part of the priming liquid also flows into the guide wire lumen 70 and primes the guide wire lumen 70.

Here, when the advancement output from the pusher wire 66 is applied and the elastic deformation of the coil portion 88 increases, the priming liquid flows laterally from the gap between the bare walls 89. Therefore, the amount of priming liquid discharged from the communication port 84a and colliding with the port 80 is reduced, and the pressing force of the port 80 is weakened. Therefore, it is possible to prevent the inner structure 20 on the distal end side from advancing larger than the coil portion 88. In addition, the priming liquid that has flowed laterally from the coil portion 88 can easily fill the lumen 22 of the outer intermediate tube 26. Thereby, the priming of the device 10 is completed.

After the priming is completed, the supply of the priming liquid is stopped, so that the pressing force applied to the port 80 is eliminated. For this reason, as shown to FIG. 8C, the coil part 88 extended in the front end direction is elastically returned so that it may shrink in the base end direction. Accordingly, the distal end displacement portion 90 is displaced to the original position, so that the inner distal end tube 64 is also pulled in the proximal direction via the pusher wire 66, and the distal end side blocking portion 72 is the distal end of the outer tube body 18. The opening 24a is closed. Therefore, the device 10 automatically shifts to a state where it can be inserted into the living body lumen after the priming is completed. By thus blocking the distal end opening 24a, it is possible to prevent body fluid such as blood from entering the lumen 22 from the distal end opening 24a during insertion into the living body lumen.

As described above, according to the device 10 according to the present embodiment, the outer tube is provided at the time of priming with a simple configuration in which the elastic portion 86 is provided in the middle of the inner structure 20 in the axial direction and on the proximal side of the pressure receiving portion. The priming liquid supplied to the lumen 22 of the body 18 can be easily distributed. That is, when the port 80 which is a pressure receiving portion receives the pressure of the priming liquid flowing through the lumen 22, the coil portion 88 is elastically deformed to cause the closing portion 72 to advance toward the distal end side relative to the outer tube body 18, thereby blocking The lumen 22 closed by the portion 72 is opened, a fluid circulation path is formed, and the priming liquid can be smoothly discharged from the tip opening 24a. Therefore, the device 10 can omit the pre-operation that the operator has requested at the time of priming, and the blocking portion 72 may inadvertently block the tip opening 24a at the time of priming, or the tip opening 24a Inconveniences such as inserting into a living body lumen without forgetting the occlusion can be avoided, and priming can be performed efficiently and satisfactorily.

In addition, the device 10 can be simply configured because the port 80 functions as a pressure receiving portion, and no other pressure receiving portion is required. Further, the device 10 allows the priming liquid to easily collide with the port 80 when the priming liquid is discharged from the inner proximal tube 68 because the port 80 is disposed in the vicinity of the inner proximal tube 68. Can do. Thereby, the port 80 can be pressed more reliably and the elastic deformation of the elastic part 86 can be promoted.

Furthermore, the device 10 has a simpler configuration because the number of parts of the inner structure 20 is reduced because the elastic portion 86 is integrally formed at the distal end of the inner proximal tube 68. In this case, it is possible to easily provide the coil portion 88 by cutting the inner proximal tube 68 in a spiral shape, and this coil portion 88 is smoothly elastically deformed along the axial direction so that the blocking portion 72 is at the distal end. Can advance to the side.

In addition, the device 10 according to the present invention is not limited to the above-described embodiment, and various application examples and modifications can be taken. For example, the device 10 is not limited to a stent delivery catheter that delivers the stent 12, and can be applied to various devices that can be inserted into a living body lumen.

[First Modification]
As shown in FIGS. 9A and 9B, the device 10A according to the first modified example is configured as an over-the-wire type in which the guide wire 32 is disposed so as to penetrate the entire length of the device 10A. It differs from the device 10 concerning. In the following description, the same reference numerals are given to the same configuration or the same function as the device 10 according to the present embodiment, and the detailed description thereof is omitted.

The device 10A includes an inner tube 102 (an inner structure) having a long outer tube 100 (outer tube) in which a lumen 22 is formed to penetrate the entire length, and a guide wire lumen 70 into which the guide wire 32 is inserted. ). The distal end opening 100 a of the outer tube 100 communicating with the lumen 22 is blocked by a nose cone 104 (blocking portion) provided at the distal end of the inner tube 102. The nose cone 104 has a flat base end surface 104 a that faces the front end surface (the front end opening 100 a) of the outer tube 100. Further, a treatment portion 106 (for example, a stent, a stent graft, a balloon, or the like) is disposed (or installed) near the distal end side of the inner tube 102.

The inner tube 102 is disposed on the distal end side in the lumen 22 and has a nose cone 104, a proximal shaft 110 received in the lumen 22 on the proximal end side of the distal shaft 108, and the distal shaft 108. And an elastic member 112 (elastic portion) for connecting the proximal shaft 110. The guide wire lumen 70 communicates the distal shaft 108, the elastic member 112, and the proximal shaft 110. The elastic member 112 has an elastic force that can be freely expanded and contracted (elastically deformed) in the axial direction, and the distal shaft 108 can be advanced or retracted relative to the proximal shaft 110.

In the device 10A configured as described above, when the priming liquid is supplied to the lumen 22 of the outer tube 100, the priming liquid moves to the distal end side through the inside of the outer tube 100, and the base end surface 104a (pressure receiving portion) of the nose cone 104 Collide with. As a result, the tip shaft 108 is pressed in the tip direction, and this stress (advance output) is transmitted to the elastic member 112 via the tip shaft 108. As a result, the elastic member 112 is elastically deformed so as to extend in the axial direction, and the tip shaft 108 can be easily displaced to the tip side.

Therefore, the distal end opening 100a of the outer tube 100 closed by the nose cone 104 is opened, and the priming liquid can be smoothly discharged from the distal end opening 100a. After the priming is completed, the distal end shaft 108 is contracted in the proximal direction based on the elastic deformation of the elastic member 112, whereby the distal end opening 100 a is closed again by the nose cone 104.

[Second Modification]
As shown in FIGS. 10A and 10B, the device 10 </ b> B according to the second modified example is different in that the inner structure housed in the lumen 22 of the outer tube 100 is configured as one inner tube 120. It differs from the device 10 and 10A which concern on a form and a 1st modification.

The inner tube 120 has a closed portion 72 at the tip and a fluid flow path 84 along the axial direction. The guide wire 32 may be inserted into the flow path 84. In addition, an elastic portion 122 (coil portion 124) is provided at a position away from the placement position of the treatment portion 106 of the inner tube 120 toward the proximal end side by a predetermined distance. The coil portion 124 supports the inner tube 120 on the distal end side relative to the coil portion 124 so as to freely advance and retract.

And the protrusion 126 is provided in the inner wall which comprises the flow path 84 between the mounting location of the treatment part 106, and the coil part 124, This protrusion 126 functions as a pressure receiving part which receives the pressure of priming liquid. That is, the inner tube 120 receives a pressing force toward the distal end when the priming liquid that vigorously flows in the flow passage 84 collides with the protrusion 126. Thereby, the coil part 124 can be extended (elastically deformed), and the inner tube 120 on the distal end side of the coil part 124 can be displaced in the distal direction. At this time, the priming liquid flows out from the gap between the bare walls 125 of the coil portion 124, so that the lumen 22 of the outer tube 100 can be primed.

In short, the medical device for living body lumen is not particularly limited with respect to the position of the pressure receiving portion that receives the pressing force of the priming liquid. Further, the configuration of the inner structure housed in the outer tube is not particularly limited, and various configurations that can be housed along the axial direction of the outer tube can be adopted. For example, the distal end member disposed on the distal end side of the elastic portion and the proximal end member disposed on the proximal end side of the elastic portion are not limited to the hollow tubular body, and a solid member is applied. You can also.

In the above description, the present invention has been described with reference to preferred embodiments. However, the present invention is not limited to the above-described embodiments, and various modifications can be made without departing from the scope of the present invention. Yes.

Claims (8)

  1. An outer tube (18, 100) capable of being delivered through a biological lumen and having an axially extending lumen (22) therein;
    It has an obstruction | occlusion part (72,104) accommodated in the said lumen | bore (22), and obstruct | occludes the said lumen | bore (22) in the front-end | tip of the said outer tube | pipe (18,100), and flows through the said lumen | bore (22) An inner structure (20, 102, 120) having a pressure receiving part (80, 92, 104a, 126) for receiving the pressure of fluid
    The inner structure (20, 102, 120) has an elastic portion in the middle of the inner structure (20, 102, 120) in the axial direction and closer to the base end side than the pressure receiving portion (80, 92, 104a, 126). (86, 86A, 86B, 86C, 112, 122)
    The elastic portion (86, 86A, 86B, 86C, 112, 122) is elastically deformed by the pressure receiving portion (80, 92, 104a, 126) receiving the pressure of the fluid, and the outer pipe (18, 100) The medical device (10, 10A, 10B) for living body lumen, wherein the occlusion portion (72, 104) is advanced toward the distal end side relative to 100).
  2. The medical device (10, 10A) for biological lumen according to claim 1,
    The inner structure (20, 102) includes a tip member (64, 108) having the blocking portion (72, 104) and the pressure receiving portion (80, 92, 104a, 126),
    A proximal end member (68, 110) for supporting the distal end member (64, 108) on the proximal end side of the distal end member (64, 108),
    The elastic portions (86, 86A, 86B, 86C, 112) are arranged on the proximal end side of the distal end member (64, 108), the distal end side of the proximal end member (68, 110), or the distal end member (64, 108). ) And the proximal end member (68, 110). A medical device for biological lumen (10, 10A), characterized in that
  3. The medical device (10) for a biological lumen according to claim 2,
    The distal end member (64) has a guide wire lumen (70) into which a guide wire (32) can be inserted, and is curved at the proximal end side so as to be outside the intermediate position in the axial direction of the outer tube (18). A port (80) exposing the guidewire (32);
    The medical device (10) for living body lumen, wherein the port (80) constitutes the pressure receiving part (80, 92).
  4. The biological lumen medical device (10) according to claim 3,
    The distal end member (64) is supported by a support body (66) that is fixed to the proximal end member (68) and extends in the distal end direction, and the port (80) is in the vicinity of the proximal end member (68). A medical device (10) for a living body lumen, which is disposed at a position.
  5. The medical device (10) for a biological lumen according to claim 2,
    The base end member (68) is a tube having a flow passage (84) through which the fluid can flow.
    The elastic portion (86, 86A, 86B) is integrally formed at the distal end of the proximal end member (68). The medical device (10) for living body lumens.
  6. The medical device (10) for a biological lumen according to claim 5,
    The said elastic part (86, 86A, 86B) has a coil part (88, 88a, 88b) which can be expanded-contracted to an axial direction by cutting the said base end member (68) helically, The biological tube characterized by the above-mentioned. Cavity medical device (10).
  7. The medical device (10) for a biological lumen according to claim 2,
    The elastic portion (86C) is composed of an elastic rubber (96) that displaces the distal end member (64) relative to the proximal end member (68). ).
  8. The medical device (10) for living body lumen according to any one of claims 1 to 7,
    A medical device for living body lumen, further comprising a stent (12) housed in an expandable state between the outer tube (18, 100) and the inner structure (20, 102, 120). (10).
PCT/JP2013/050395 2013-01-11 2013-01-11 Medical device for biological lumen WO2014109048A1 (en)

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Application Number Priority Date Filing Date Title
PCT/JP2013/050395 WO2014109048A1 (en) 2013-01-11 2013-01-11 Medical device for biological lumen

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3178450A1 (en) * 2015-12-10 2017-06-14 Biotronik AG Insertion catheter and catheter assembly

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6422262A (en) * 1987-06-27 1989-01-25 Braun Melsungen Ag Catheter apparatus
JPH08504652A (en) * 1993-06-30 1996-05-21 カーディオバスキュラー ダイナミクス、インコーポレイテッド Perfusion catheter of low profile shape
JP2012170469A (en) * 2011-02-17 2012-09-10 Terumo Corp Stent delivery system

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS6422262A (en) * 1987-06-27 1989-01-25 Braun Melsungen Ag Catheter apparatus
JPH08504652A (en) * 1993-06-30 1996-05-21 カーディオバスキュラー ダイナミクス、インコーポレイテッド Perfusion catheter of low profile shape
JP2012170469A (en) * 2011-02-17 2012-09-10 Terumo Corp Stent delivery system

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3178450A1 (en) * 2015-12-10 2017-06-14 Biotronik AG Insertion catheter and catheter assembly

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