JP2009233203A - Pin - Google Patents

Abstract

<P>PROBLEM TO BE SOLVED: To provide a pin which makes it possible to visually confirm by using imaging (or radiography) that the pin has punctured into the tissue when a bio-indwelling material is fixed to a tissue in a living body with the pin. <P>SOLUTION: The pin 5 includes a main body including a head part 51, a puncturing part 52 extending and protruding from the end 511 of the head part 51, and a backbone part 53 extending and protruding from halfway the head part 51, as well as an expansive imaging marker 8a provided at the puncturing part 52. The head part 51 and the puncturing part 52 are each bar-shaped and straight. When the puncturing part 52 pierces a blood vessel wall together with a graft, the graft is fixed at the blood vessel wall. The backbone part 53 is bar-shaped and curved or bent so that the side of puncturing part 52 can dent. The marker 8a is arranged at the puncturing part 52 in its longitudinal direction in the way that it can extend or shrink. <P>COPYRIGHT: (C)2010,JPO&INPIT

Description

  The present invention relates to a pin for fixing an indwelling object to a living tissue in a living body.

  Conventionally, when treating an aneurysm, the aneurysm is surgically removed, and an artificial blood vessel (a tube made of an artificial material) is transplanted to that portion, or another new blood flow called bypass surgery. Therapies were to form tracts and secure blood. However, patients who develop aneurysms are generally elderly, and such major surgery is often difficult due to the heavy burden on the patient, and complications during and after surgery are likely to occur. It was accompanied by.

  In addition, a device for treating an aneurysm by placing and transplanting a stent graft (a medical device having a metal skeleton (stent) sewn on an artificial blood vessel (graft)) percutaneously without performing such a surgical operation, and A method has been proposed (see, for example, Patent Document 1). This treatment has the advantage of significantly reducing the risk of surgery and the burden on the patient.

  Stent grafts are broadly classified as follows: (1) The diameter is expanded in a natural state where no external force is applied, and a radial compressive force is applied to the stent graft to reduce the diameter. A so-called self-expanding type that is transferred to a target site in the artery (a treatment site where an aneurysm is formed) in a state, where the compressive force is removed to self-expand the diameter, and (2) In a natural state where external force is not applied, the diameter is reduced, and after transferring to the target site in the artery, the balloon of the separately inserted balloon catheter is inflated, and the metal member installed at the end of the stent graft is expanded. There is a so-called balloon expanding type structure in which the expanded state is maintained by the plastic deformation of the metal member accompanying the expansion.

  However, all of these stent grafts are obtained by fixing a cloth-like graft to a stent that is a metal skeleton, and have a relatively large diameter as a tube for transferring the stent graft when the stent graft is placed. It is necessary to use a tube. For this reason, it is desired to reduce the diameter of the tube.

  Therefore, a method has been proposed in which only the graft is fixed to the blood vessel wall with a pin, and the graft is placed and transplanted to treat the aneurysm. According to this treatment method, the graft can be folded smaller than a stent graft, and a tube having a relatively small diameter can be used as a tube for transferring the graft, thereby further reducing the burden on the patient. can do.

  However, the conventional pin has a drawback that when the graft is fixed to the blood vessel wall, it cannot be visually confirmed that the pin has been punctured into the blood vessel wall.

JP 2000-279434 A

  An object of the present invention is to provide a pin capable of visually confirming that a pin has been punctured into a living tissue under contrast (under fluoroscopy) when the indwelling object is fixed to the living tissue with a pin in the living body. It is in.

Such an object is achieved by the present inventions (1) to (14) below.
(1) A pin for fixing an indwelling object to a living tissue in a living body,
A pin body having a stick-like puncture portion that is punctured into a living tissue together with the indwelling object;
A pin that is provided on the puncture portion and includes a marker having a contrast property that is deformable or movable in a longitudinal direction of the puncture portion.

  (2) The pin according to (1), wherein the marker is a variable shape body that is installed to be extendable and contractable in the longitudinal direction of the puncture unit.

  (3) One end portion of the shape variable body is located at a distal end portion of the puncture portion, and when the puncture portion punctures a biological tissue, the shape variable body moves toward a proximal direction, thereby the shape variable body. The pin according to (2), wherein the pin is configured to contract.

  (4) The said shape variable body is a pin as described in said (2) or (3) comprised by the coil-shaped wire wound around the said puncture part.

  (5) The pin according to (1), wherein the marker is a moving body that is movably installed along a longitudinal direction of the puncture unit.

  (6) The pin according to (5), wherein the moving body has an annular shape, and the puncture portion is inserted through the moving body.

  (7) The said moving body is a pin as described in said (5) or (6) currently hold | maintained at the front-end | tip part of the said puncture part.

  (8) The pin according to any one of (5) to (7), further including holding means having a first stopper that prevents the moving body from being detached from the puncture portion.

  (9) The holding means prevents movement of the movable body in the proximal direction, and allows the movable body to move in the proximal direction when the puncture portion punctures a living tissue. The pin according to (8) above, which has a stopper.

  (10) The pin according to any one of (1) to (9), wherein a tip fixing marker having contrast is provided at a tip of the puncture portion.

  (11) The pin according to (10), wherein the tip fixed marker has a lower contrast than the marker.

  (12) The pin according to any one of (1) to (11), wherein a proximal end fixed marker having contrast is provided at a proximal end of the puncture portion.

  (13) The pin according to (12), wherein the proximal end fixed marker has a lower contrast than the marker.

(14) The pin body includes a substantially straight head,
A portion extending from the head and projecting, having a portion that comes into contact with the indwelling object, and a spine for closely attaching the indwelling object to a living tissue,
The puncture portion extends from the head and protrudes so that the angle θ between the axis of the puncture portion and the axis of the head is less than 90 °. The pin according to any one of (1) to (13), which is inclined with respect to the pin.

  According to the present invention, a marker having contrast properties is provided, and when the puncture portion punctures a living tissue (a living tissue and an indwelling object), the marker is deformed (for example, contracted) or in the longitudinal direction of the puncture portion. Since it moves, it can be visually recognized (under fluoroscopy) that the pin has been punctured into the living tissue. Thereby, the operation | work which fixes an indwelling object with a pin with respect to a biological tissue in the living body can be performed reliably.

Hereinafter, the pin of the present invention will be described in detail based on a preferred embodiment shown in the accompanying drawings.
The present invention can be applied to various pins for fixing an indwelling object to a living tissue in a living body. However, in the following embodiments, the present invention is typically used in the vicinity of an aneurysm of a blood vessel. A case will be described in which the graft inserted and indwelled is applied to a pin for fixing to a blood vessel wall (inside a blood vessel).

<First Embodiment>
FIG. 1 is a side view showing an embodiment of a pin driving device used when a graft is fixed with a pin shown in FIG. 2 is a diagram showing the pin driving device shown in FIG. 1, in which FIG. 2 (a) is a cross-sectional view and FIG. 2 (b) is a front view. 3 is a side view showing the first embodiment of the pin of the present invention, and FIG. 4 shows a state in which the graft inserted and placed near the aneurysm of the blood vessel is fixed to the blood vessel wall with the pin shown in FIG. FIGS. 5 to 9 are cross-sectional views for explaining the operation of the pin driving device shown in FIG.

  In the following, the left side in FIGS. 1, 2, and 5 to 9 is referred to as “tip”, the right side is referred to as “base end (rear end)”, and the lower side in FIGS. 3 and 4 is referred to as “tip”. The upper side is described as “base end”.

  1 and 2 show a state where the balloon is expanded. Moreover, in FIGS. 6-9, the graft | graft and the blood vessel wall are shown typically.

  The pin (fixing tool) 5 shown in FIG. 3 and FIG. 4 is a graft (indwelling object) 200 that is an artificial blood vessel inserted and placed in the vicinity of an aneurysm 320 in a blood vessel 300 such as an aorta. ) In the blood vessel wall (in-vivo tissue) 310.

  The pin driving device (pin driving catheter) 1 shown in FIGS. 1 and 2 is a device for penetrating (puncturing) the pin 5 into the blood vessel wall 310 in the blood vessel 300, as shown in FIG. In this apparatus, the graft 200 inserted and placed in the vicinity of the aneurysm 320 in the blood vessel 300 such as the aorta is fixed to the blood vessel wall 310 with the pin 5 in the blood vessel 300.

First, the graft 200 will be described.
As shown in FIG. 4, the graft 200 has a shape and size corresponding to the shape and size of the blood vessel 300 to which the graft 200 is fixed, and is usually cylindrical. The graft 200 can be folded or expanded from the folded state.

  The graft 200 may be any membrane (membrane) that does not allow permeation of blood flow. For example, a fibrous porous membrane such as a woven fabric, a knitted fabric, a nonwoven fabric, or a paper material, a non-fibrous porous membrane, and a polymer sheet. A dense film such as

  Examples of the material (fiber) of the graft 200 include cellulose fibers, cotton, linter, kapok, flax, cannabis, ramie, silk, wool, and other natural fibers, nylon (polyamide), tetron, rayon, cupra, acetate, Examples thereof include chemical fibers such as vinylon, acrylic, polyethylene terephthalate (polyester), and polypropylene, or combinations (blends and the like) of two or more of these natural and chemical fibers.

  Other examples of the material of the graft 200 (polymer sheet) include, for example, polyesters such as polyethylene, polypropylene, polyurethane, polyethylene terephthalate, and polybutylene terephthalate, polyvinyl chloride, polytetrafluoroethylene, natural rubber, and isoprene rubber. And various rubbers such as silicone rubber, styrene-butadiene rubber and latex rubber, and various thermoplastic elastomers such as polyamide, polyester and polyurethane.

  The graft 200 may be a laminate of two or more layers made of the same or different materials. Further, the graft 200 may be hydrophilized or hydrophobized.

  The graft 200 is fixed to a normal site of the blood vessel 300 by a pin 5 described later. In addition, the graft 200 is fixed at a plurality of locations along the circumferential direction (over one circumference) at a site upstream of the blood flow by the plurality of pins 5. A fixed state is shown.

Next, the pin 5 will be described.
As shown in FIGS. 3 and 4, the pin 5 includes a pin main body 50 and a marker 8 a that is installed on the pin main body 50 and has a contrast property.

The pin main body 50 includes a head 51, a puncture part (penetration part) 52 that extends and protrudes from the head 51, and a spine 53 that extends and protrudes from the head 51. In the present embodiment, the puncture part 52 extends and protrudes from the tip part 511 of the head 51, and the spine part 53 extends and projects from the middle of the head 51.
The head 51 of the pin body 50 is rod-shaped and has a substantially straight shape.

  Further, the puncture part 52 is a part that penetrates (pierces) the blood vessel wall 310 together with the graft 200, and has a rod shape and a linear shape. The puncture portion 52 penetrates the blood vessel wall 310 together with the graft 200, so that the graft 200 is fixed to the blood vessel wall 310. Further, the distal end portion (end portion opposite to the head portion 51) 521 of the puncture portion 52 is pointed, so that the puncture portion 52 can penetrate the graft 200 and the blood vessel wall 310 easily and reliably. it can.

  The spine portion 53 is rod-shaped and is curved or bent (curved in the configuration shown) so that the puncture portion 52 side is concave. A distal end portion (an end portion opposite to the head portion 51) 531 of the spine portion 53 is a portion that comes into contact (pressure contact) with the graft 200. The distal end portion 531 comes into contact with the graft 200, and the graft 200 is attached to the blood vessel wall. The graft 200 is brought into close contact with the blood vessel wall 310 by being pressed against the blood vessel 310. In this way, the graft 200 can be reliably adhered to the blood vessel wall 310.

  In this embodiment, the axis 520 of the puncture unit 52 is inclined with respect to the axis 510 so that the angle (angle) θ formed by the axis 520 and the axis 510 of the head 51 is less than 90 °. . The pin 5 is installed so that the head 51 is positioned upstream of the blood flow from the puncture portion 52 when the graft 200 is fixed to the blood vessel wall 310.

  Thereby, the puncture unit 52 is punctured so as to be inclined with respect to the blood vessel wall 310, and the blood flow acts on the pin 5 in the direction in which the puncture unit 52 pierces the blood vessel wall 310, thereby the puncture unit 52. Becomes difficult to escape from the blood vessel wall 310, and the graft 200 can be reliably fixed to the blood vessel wall 310. Further, as will be described later, the puncture unit 52 can penetrate the graft 200 and the blood vessel wall 310 easily and smoothly.

  Here, the angle θ is preferably greater than 0 ° and less than 90 °, and more preferably about 40 to 50 °. As a result, the graft 200 can be reliably fixed by the blood vessel wall 310, and the puncture portion 52 can penetrate the graft 200 and the blood vessel wall 310 more easily and smoothly.

Moreover, when the length of the head 51 is a and the length b of the puncture portion 52 is, a / b is more preferably about 0.1 to 2, and about 0.5 to 1.5. Is more preferable. In particular, it is preferable that the length a of the head 51 and the length b of the puncture portion 52 are set to be approximately equal. In the present embodiment, the length a of the head 51 and the length b of the puncture unit 52 are set to be approximately equal.
Further, the length of the spine 53 is set longer than the length b of the puncture portion 52.

  Note that the dimensions of the head 51, the puncture unit 52, and the spine 53 are not particularly limited and are appropriately set according to various conditions. The length a of the head 51 is, for example, about 1 to 20 mm. It is preferable that it is about 2-20 mm.

  Moreover, the length b of the puncture part 52 is preferably about 2 to 40 mm, for example, and more preferably about 5 to 10 mm.

  Moreover, it is preferable that the length of the spine part 53 is about 4-100 mm, for example, and it is more preferable that it is about 8-80 mm.

  The pin body 50 has elasticity. That is, when the pin body 50 is deformed by applying an external force to the pin body 50, the puncture portion 52 and the spine portion 53 approach or contact each other, and when the external force is released (natural state), a restoring force (elasticity) Force) to restore the original shape.

  Examples of the constituent material of the pin body 50 include pseudoelastic metals such as stainless steel, Ni—Ti alloy, Cu—Zn alloy, and Ni—Al alloy, tungsten, tungsten alloy, titanium, titanium alloy, tantalum, and nickel. , Various metals such as chromium and cobalt alloys.

  The marker 8a is installed in the puncture part 52 of the pin main body 50, and has contrast properties under X-ray fluoroscopy (including CT scan), MRI, or the like. Thereby, the marker 8a can be visually recognized under X-ray fluoroscopy, MRI, or the like (under contrast). In the following description, each of these perspectives is typically expressed as “under fluoroscopy”.

  The marker 8a is deformable, and in this embodiment, the marker 8a is formed of a variable shape that can be expanded and contracted in the longitudinal direction of the puncture portion 52, that is, a coil-shaped wire wound around the puncture portion 52. .

  The marker 8a may have elasticity (for example, a coil spring) or may not substantially have elasticity, but in the present embodiment, the marker 8a is typically configured by a coil spring. The case where this is done will be described.

  As shown in FIG. 3, the marker 8a is installed in the puncture unit 52 in a natural state (a state in which no external force is applied to the marker 8a), that is, in a sparse (coarse) state. Further, the distal end portion (one end portion) 81 of the marker 8 a is located at the distal end portion 521 of the puncture portion 52, and the proximal end portion (other end portion) 82 is fixed to the proximal end portion 522 of the puncture portion 52. In this state, the entire marker 8a looks thin under fluoroscopy.

  When the puncture portion 52 penetrates (pierces) the graft 200 and the blood vessel wall 310, the tip portion 82 of the marker 8a contacts the graft 200 (blood vessel wall 310), and only the puncture portion 52 moves in the distal direction. Thereby, the front-end | tip part 82 of the marker 8a moves to a base end direction with respect to the puncture part 52 (refer FIG.7 (d), (e)). Thereby, as shown in FIG. 4, the marker 8 a contracts (deforms) and gathers (consolidates) at the proximal end portion 522 of the puncture portion 52. That is, the marker 8a changes from a sparse state to a dense state. In this state, the marker 8a looks dark under X-ray fluoroscopy.

  Thus, it can be visually recognized (confirmed) under fluoroscopy that the puncture unit 52 has penetrated the graft 200 and the blood vessel wall 310.

  In addition, if the puncture unit 52 does not penetrate the graft 200 and the blood vessel wall 310, the marker 8a is restored to its original shape by a restoring force (elastic force). The fact that 200 and the blood vessel wall 310 have not been penetrated can also be visually recognized under fluoroscopy.

  The marker 8a is made of, for example, a material having contrast properties with respect to X-rays, MRI, etc., such as an X-ray opaque material, and is particularly preferably made of a metal material. Examples of the metal material constituting the marker 8a include metals such as platinum, gold, silver, and tungsten, or alloys thereof, and stainless steel covered with these metals or alloys, Ni-Ti alloys, Ni -Pseudoelastic metals such as Al-based alloys, metals such as titanium, titanium alloys, tantalum, nickel, chromium, iridium, and cobalt-based alloys. Stainless steel, Ni-Ti alloy, Cu-Zn alloy, Ni-Al alloy covered with a layer (coating film) containing X-ray opaque material such as barium sulfate, barium carbonate, bismuth oxide, etc. And the like, and metals such as titanium, titanium alloys, tantalum, nickel, chromium, iridium, and cobalt-based alloys.

Next, the pin driving device 1 will be described.
As shown in FIG. 1 and FIG. 2, a pin driving device (pin driving catheter) 1 has a flexible main body portion 10 and a balloon (expanded body) that can be expanded and contracted. 6 is provided.

  The main body 10 includes an outer cylinder (outer tube) 2 that is a casing, an inner cylinder (inner tube) 3 that is an inner member, and a pusher 4 that pushes a pin 5. The distal end sides of the outer cylinder 2 and the inner cylinder 3 are closed, and the proximal end sides are open.

  The pusher 4 is installed in the inner cylinder 3 so as to be movable along the longitudinal direction of the inner cylinder 3 (the pusher 4). The inner cylinder 3 is installed in the outer cylinder 2 so as to be movable along the longitudinal direction of the outer cylinder 2 (inner cylinder 3). The inner cylinder 3 is regulated so as not to move (rotate) in the circumferential direction with respect to the outer cylinder 2, and as shown in FIG. 2, in the initial state (assembled state), the distal end portion of the inner cylinder 3 Is in contact with the tip wall of the outer cylinder 2.

  A hub (branching hub) 7 is installed (fixed) at the base end of the outer cylinder 2. The hub 7 has a port 71 and a port (branch port) 72. The port 71 communicates with a lumen of the outer cylinder 2, and the port 72 communicates with a lumen 22 (to be described later) of the outer cylinder 2. Yes. The outer cylinder 2 can be operated by holding the hub 7.

  Further, the base end portion of the inner cylinder 3 protrudes from the port 71 of the hub 7 to the base end side (outside). A grip 34 is installed (fixed) at the base end of the inner cylinder 3 so that the inner cylinder 3 can be operated by gripping the grip 34.

  Further, the base end portion of the pusher 4 protrudes from the grip portion 34 of the inner cylinder 3 to the base end side (outside). A gripping portion 41 is installed (fixed) at the proximal end of the pusher 4 so that the pusher 4 can be operated by gripping the gripping portion 41.

  Moreover, the front-end | tip part of the pusher 4 is expanded in diameter. The diameter of the tip of the pusher 4 is preferably set to be slightly smaller than the inner diameter of the inner cylinder 3. Thereby, the pin 5 can be pushed reliably. The pusher 4 can move the pin 5 in the distal direction with respect to the inner cylinder 3.

  A portion of the inner cylinder 3 on the tip side of the pusher 4 constitutes a storage portion 33 in which the pin 5 is stored. The pin 5 has a shaft 510 of the head 51, a shaft 520 of the puncture portion 52, and a shaft of the spine 53 in the storage portion 33, that is, a portion on the tip side of the pusher 4 in the inner cylinder 3. In a state of being elastically deformed so as to be substantially parallel or substantially coincident, the head 51 side is the tip side, and the puncture portion 52 side is the lower side in FIG. 2A (the opening 21 side described later). Is done. In this embodiment, it is comprised so that the some pin 5 can be accommodated, and in the example of illustration, the two pins 5 are accommodated. It goes without saying that only one pin 5 may be accommodated.

  Further, an opening 21 for discharging the outlet of the pin 5, that is, the pin 5 stored in the storage portion 33, is formed on the side of the distal end portion of the outer cylinder 2 (lower side in FIG. 2A). Yes. The lumen of the outer cylinder 2 is formed further to the tip side than the tip of the opening 21.

  Further, in the vicinity of the opening 21, for example, around the opening 21, there is a marker (not shown) for confirming the position of the opening 21 in the living body under X-ray fluoroscopy (indicating the position of the opening 21 in the living body). Preferably it is installed.

  This marker is made of a radiopaque material such as a metal such as platinum, gold, silver, tungsten, or an alloy thereof. Further, the marker may be a layer (for example, a coating film) in which the X-ray opaque material or other X-ray opaque materials such as barium sulfate, barium carbonate, bismuth oxide and the like are blended.

  Note that the marker is not limited to fluoroscopy, and may be one that can confirm the position of the opening 21 in, for example, CT scan, MRI, or the like.

  The tip wall of the inner cylinder 3 constitutes a contact portion 32 that can contact the head 51 of the pin 5. Thus, the pin 5 can be moved in the proximal direction with respect to the outer cylinder 2 by the inner cylinder 3.

  Further, an opening 31 serving as an outlet of the pin 5 is formed at a position corresponding to the opening 21 on the side (lower side in FIG. 2A) of the tip of the inner cylinder 3. The opening 31 is larger than the opening 21. That is, when viewed from the lower side in FIG. 2A (in FIG. 2B), the opening 31 includes the opening 21 of the outer cylinder 2. Specifically, the opening 31 is formed from the base end of the opening 21 to the contact portion 32 positioned on the tip side of the opening 21 (the base end of the opening 31 and the base end of the opening 21 are substantially equal to each other). The tip of the opening 31 is located closer to the tip than the tip of the opening 21).

  Here, the length from the head 51 of the pin body 50 to the puncture portion 52 of the pin 5 in the state accommodated in the inner cylinder 3 is L1, and the length of the opening 21 in the longitudinal direction of the outer cylinder 2 is L2. In the state (the state shown in FIG. 2), the length from the contact portion 32 of the inner cylinder 3 to the base end of the opening 21 (opening 31) (the length of the opening 31 in the longitudinal direction of the inner cylinder 3) is L3. When the length from the head 51 of the pin body 50 to the spine 53 (the length of the pin body 50) of the pin 5 in the state of being housed in 3 is L4, the following formulas (1) to (3) It is preferable that That is, it is preferable that the dimensions and positions of the openings 21 and 31 and the dimensions of each part of the pin body 50 (pin 5) are set so as to satisfy the following expressions (1) to (3).

L2 <L1 (1) Formula L1 <L3 (2) Formula L3 <L4 (3) Formula The working fluid is injected (supplied) to the tip of the outer cylinder 2 (main body 10). A balloon 6 that can be expanded and contracted by extraction (discharge) is provided.

  The balloon 6 is installed on the opposite side of the opening 21 of the outer cylinder 2 via the central axis 23 of the outer cylinder 2 (main body part 10), and is expanded eccentrically with respect to the central axis 23 in the direction opposite to the opening 21. It is configured to When the balloon 6 is expanded, the vicinity of the opening 21 of the outer cylinder 2 is pressed against the blood vessel wall 310 via the graft 200 and closely contacts (see FIG. 6). Therefore, the balloon 6 constitutes the main part of the pressing means for pressing the vicinity of the opening 21 of the outer cylinder 2 of the main body 10 against the blood vessel wall (biological tissue) 310. Since the balloon 6 is installed on the opposite side of the opening 21 and is eccentrically expanded in the direction opposite to the opening 21, this ensures that the opening 21 is directed toward the blood vessel wall 310, so that the outer tube 2 The vicinity of the opening 21 can be pressed against the blood vessel wall 310.

  The balloon 6 is formed by forming a film-like material into, for example, a sheet shape or a cylindrical shape, and is fixed to the outer peripheral surface of the outer cylinder 2 in an airtight or liquid tight manner. This fixing is performed by, for example, fusion or bonding with an adhesive.

  The balloon 6 is in a state of being collapsed and folded before expansion (when deflated), but when the working fluid is supplied to the inside of the balloon 6 and expanded, conversely, when the working fluid is discharged from the inside, Shrink.

  The balloon 6 is made of various polymer materials (particularly thermoplastic resin). In this case, the balloon 6 is preferably made of a material having flexibility as a whole.

  The constituent material of the balloon 6 is, for example, a polyester resin such as polyethylene terephthalate or polybutylene terephthalate or a polyester elastomer containing the same, an olefin resin such as polyethylene or polypropylene, or a material subjected to crosslinking treatment (particularly by electron beam irradiation). Cross-linked), polyamide resins such as nylon 11, nylon 12, nylon 610 or the like, polyamide elastomers containing the same, polyurethane resins, ethylene-vinyl acetate copolymers or those obtained by crosslinking these, silicone resins or these Examples thereof include materials such as polymer blends and polymer alloys containing at least one of them.

  Furthermore, you may comprise the balloon 6 with the laminated body which laminated | stacked the film | membrane which consists of these materials. In this case, for example, a laminate can be obtained by coextrusion molding of each layer, joining each layer by adhesion, fusion, or the like, or forming another layer by coating on one layer. . In addition, a soft resin layer, a hard resin layer, a lubrication material layer, an antithrombotic material layer, or the like may be provided outside or inside the layer made of the above material.

  Examples of the constituent material of the balloon 6 include antithrombotic materials such as heparin, prostaglandin, urokinase, and arginine derivatives, and X such as barium sulfate, barium carbonate, bismuth oxide, and tungsten that function as the aforementioned markers. A radiopaque material may be blended.

  Further, a lumen 22 is formed in the outer cylinder 2 as a flow path along which the working fluid for expanding and contracting the balloon 6 flows. The lumen 22 is formed over substantially the entire length of the outer cylinder 2. The distal end of the lumen 22 opens (opens) to the side of the distal end portion of the outer cylinder 2, that is, the outer peripheral surface of the outer cylinder 2 positioned inside the balloon 6, and the proximal end side communicates with the port 72 of the hub 7. is doing. Thereby, the inside of the balloon 6 and the port 72 communicate with each other via the lumen 22.

  Further, for example, a syringe 400 filled with working fluid is connected to the port 72 as supply / discharge means for supplying / discharging the working fluid to / from the balloon 6.

  As the working fluid, a liquid whose volume does not change due to pressure fluctuation can be used and is preferably harmless to a living body. Among the liquids, a liquid having X-ray contrast properties is more preferable. For example, a liquid obtained by diluting an X-ray contrast agent such as an arterial contrast agent several times with physiological saline can be used. . In this case, the position of the balloon 6 can be confirmed under fluoroscopy.

  The dimensions (length, outer diameter, inner diameter, etc.) of the outer cylinder 2, the inner cylinder 3, and the pusher 4 are not particularly limited, and the use site of the pin driving device 1 (the type and site of an aneurysm blood vessel) ) And cases are determined as appropriate. Usually, the lengths of the outer cylinder 2, the inner cylinder 3 and the pusher 4 are each preferably about 50 to 150 cm, and more preferably about 80 to 120 cm. Moreover, it is preferable that the outer diameter of the outer cylinder 2 is about 2-6 mm, and it is more preferable that it is about 3-5 mm.

  The outer cylinder 2, the inner cylinder 3 and the pusher 4 each have desired flexibility, and examples of the constituent material thereof include polyolefin resin, polyamide resin, urethane resin, and polyimide resin. Various thermoplastic resins such as resins or thermosetting resins can be used. Specifically, for example, polyolefin such as polyethylene, polypropylene, ethylene-propylene copolymer, ethylene-vinyl acetate copolymer (EVA), polyvinyl chloride, polyethylene terephthalate (PET), polybutylene terephthalate (PBT), etc. Various thermoplastic elastomers such as polyester, polyurethane, polyamide, polyimide, polystyrene resin, fluorine resin, styrene, polyolefin, polyvinyl chloride, polyurethane, polyester, polyamide, polybutadiene, fluorine rubber, etc. It is done.

  Next, an example of a method for using (operating) the pin driving device 1 and the pin 5, that is, a procedure for fixing the graft 200 introduced in the vicinity of the aneurysm 320 of the blood vessel 300 to the blood vessel wall 310 with the pin 5. This will be described with reference to FIGS.

  As shown in FIG. 5A, the graft 200 is already introduced into a target site of the blood vessel 300 (in the vicinity of the aneurysm 320) using, for example, a tubular introduction sheath (not shown). And

  First, as shown in FIG. 2, a plurality (two in the illustrated configuration) of pins 5 are stored in the storage portion 33 of the inner cylinder 3 of the pin driving device 1.

  Next, the pinning device 1 is percutaneously introduced into the blood vessel 300 from the thigh or the like under fluoroscopy, and the distal end portion of the main body portion 10 is transferred to a portion where the aneurysm 320 of the blood vessel 300 is present. And the opening 21 is positioned in the site | part fixed with the pin 5 of the graft 200. FIG. This positioning can be performed using a marker provided around (periphery) the opening 21.

  Next, as shown to Fig.5 (a), a working fluid is supplied to the balloon 6 with a balloon dilator (syringe 400), and the balloon 6 is expanded. Thereby, the vicinity of the opening 21 of the outer cylinder 2 is pressed against the blood vessel wall 310 through the graft 200 and is brought into close contact therewith.

  Next, as shown in FIG. 6B, the pusher 4 is pushed in the distal direction (left side in FIG. 6) in a state where the outer cylinder 2 and the inner cylinder 3 of the pin driving device 1 are fixed to the blood vessel wall 310. (Move it) Thereby, the pin 5 is pushed by the pusher 4 in the distal direction and moves. Specifically, the proximal end side pin 5 is pushed and moved in the distal direction by the pusher 4, and the distal end side pin 5 is pushed and moved in the distal direction by the pin 5.

  At this time, since L2 <L1, as shown in FIG. 6B, until the proximal end portion 512 of the head 51 moves beyond the opening 21 to the front end side (left side in FIG. 6) beyond the opening 21. The tip portion 521 of the puncture portion 52 does not reach the position of the opening 21. Since L1 <L3, the tip portion 521 of the puncture portion 52 reaches the position of the opening 21 until the head portion 51 of the pin 5 contacts the contact portion 32 of the inner cylinder 3, and the puncture portion 52 Is restored to its original shape by a restoring force (elastic force). Thereby, as shown in FIG.6 (c), the front end side of the puncture part 52 protrudes outside from the opening 21. FIG.

  The pin 5 stops when its head 51 abuts against the abutting portion 32 of the inner cylinder 3, but since L3 <L4, the distal end portion 531 of the spine 53 is positioned at the positions of the openings 21 and 31. It does not reach and is located in the inner cylinder 3 (storage portion 33) on the base end side with respect to the openings 21 and 31.

  Next, as shown in FIG. 7D, the inner cylinder 3 is pulled (moved) in the proximal direction (right side in FIG. 7) in a state where the outer cylinder 2 is fixed to the blood vessel wall 310. Thereby, the pin 5 is pushed in the proximal direction by the inner cylinder 3 and moves. Specifically, the distal end side pin 5 is pushed and moved in the proximal direction by the inner cylinder 3, and the proximal side pin 5 is pushed and moved in the proximal direction by the pin 5.

  At this time, the puncture portion 52 of the pin 5 penetrates the graft 200 and the blood vessel wall 310, and when the proximal end portion 512 of the head 51 reaches the opening 21 as shown in FIG. Restore the original shape by restoring force. Thereby, the head 51 protrudes outside from the opening 21.

  Further, when the puncture portion 52 penetrates the graft 200 and the blood vessel wall 310, the tip portion 81 of the marker 8a abuts on the graft 200 (blood vessel wall 310), and the tip portion 81 of the marker 8a is based on the puncture portion 52. As a result, the marker 8 a contracts and gathers at the proximal end portion 522 of the puncture portion 52. Thereby, it can be visually recognized through X-ray fluoroscopy that the puncture part 52 has penetrated the graft 200 and the blood vessel wall 310.

  In the present embodiment, as described above, since the length a of the head 51 and the length b of the puncture portion 52 are set to be substantially equal, the puncture portion 52 is substantially completely separated from the graft 200 and the blood vessel wall 310. , The proximal end portion 512 of the head 51 reaches the opening 21, the spine 53 is restored to its original shape, and the head 51 protrudes from the opening 21 to the outside.

  Therefore, the puncture portion 52 can be penetrated through the graft 200 and the blood vessel wall 310 by moving only the inner cylinder 3 without moving the outer cylinder 2. That is, after the vicinity of the opening 21 of the outer cylinder 2 is fixed to the blood vessel wall 310 through the graft 200, the graft 5 is moved by the pin 5 only by moving the pusher 4 and the inner cylinder 3 without moving the outer cylinder 2. 200 can be secured to the vessel wall 310.

  Moreover, since the head 51 is substantially linear, when the pin 5 is pushed in the proximal direction by the inner cylinder 3 and moved, the pin 5 can move stably, The head 51 can be prevented from protruding outside from the opening 21 before the puncture portion 52 penetrates the graft 200 and the blood vessel wall 310 almost completely.

  In addition, the shaft 520 of the puncture unit 52 is inclined with respect to the axis 510 of the head 51, whereby the puncture unit 52 is punctured so as to be inclined with respect to the blood vessel wall 310. By moving in the proximal direction, the puncture unit 52 can penetrate the graft 200 and the blood vessel wall 310 easily and smoothly.

  Thereby, the operation | work which fixes the graft 200 to the blood vessel wall 310 with the pin 5 can be performed easily, quickly and safely.

  Next, the working fluid is discharged from the balloon 6 by the balloon dilator (syringe 400), the balloon is deflated, and then, as shown in FIG. 2 and the inner cylinder 3 are pulled (moved) in the proximal direction (right side in FIG. 8). As a result, as shown in FIGS. 8G and 9H, the pin 5 is prevented from moving in the proximal direction by the pusher 4 and discharged from the opening 21 to the outside.

In this way, the graft 200 is fixed to the blood vessel wall 310 by the pin 5. The same applies to the case where the graft 200 is fixed to the blood vessel wall 310 with another pin 5.
When the above operation is completed, the pin driving device 1 is extracted from the blood vessel 300.

  As described above, according to the pin 5, the operation of fixing the graft 200 to the blood vessel wall 310 with the pin 5 can be performed easily, quickly and safely.

  In particular, since the marker 8 a is provided, it is possible to visually confirm that the puncture portion 52 has penetrated the blood vessel wall 310 under X-ray fluoroscopy (under contrast), thereby fixing the graft 200 to the blood vessel wall 310. The work to do can be performed reliably.

  Further, with this pin 5, the puncture portion 52 is difficult to come off from the blood vessel wall 310, and the graft 200 can be reliably fixed to the blood vessel wall 310. The spine portion 53 ensures that the graft 200 is securely attached to the blood vessel wall 310. It can be adhered.

  In the present invention, as described above, the marker 8a may not have elasticity, and in this case, the puncture portion 52 is more difficult to be removed from the blood vessel wall 310.

  Moreover, in this invention, the marker 8a is not limited to a coil-shaped wire, For example, it may comprise a cylinder shape and it may be comprised so that it can expand-contract.

  In the present invention, the pin body is not limited to the above-described configuration as long as it has a puncture portion, and may have the following configuration, for example.

The head 51 may be curved or bent, and may have a shape other than a rod shape, for example, a flat shape.
Moreover, the puncture part 52 may be curved or bent.

  Further, the pin body 50 may have a plurality of puncture portions 52. In this case, it is only necessary that the marker 8a is installed in at least one of the puncture units 52, but it is preferable that the marker 8a is installed in each of the puncture units 52. Moreover, the structure of the marker installed in each puncture part 52 may be the same, and may differ.

  In addition, the angle θ may be 90 °, and the axis 520 of the puncture unit 52 may not be inclined with respect to the axis 510 of the head 51.

Further, the spine 53 may be substantially linear. In this case, the spine 53 can be brought into contact with the graft 200 over substantially the entire length, whereby the graft 200 can be reliably adhered to the blood vessel wall 310.
Further, the pin main body 50 may be composed of a head 51 and a puncture portion 52.

Second Embodiment
FIG. 10 is a side view showing a second embodiment of the pin of the present invention. In the following description, the lower side in FIG. 10 is referred to as the “front end” and the upper side as the “base end”. Further, in FIG. 10, the graft and the blood vessel wall are schematically shown.

  Hereinafter, the second embodiment will be described with a focus on the differences from the first embodiment described above, and the description of the same matters will be omitted.

  As shown in FIG. 10, in the pin 5 of the second embodiment, a stopper (restoration preventing means) 54 for the marker 8a is formed in the middle of the puncture portion 52 of the pin body 50, in the vicinity of the base end portion 522 in the illustrated configuration. Is (provided). When the puncture portion 52 penetrates the graft 200 and the blood vessel wall 310, the stopper 54 can be used by the marker 8a to get over and contract at the proximal end portion 522 of the puncture portion 52. It is configured so that it cannot be overcome by the restoring force of the marker 8a. That is, in the configuration shown in the drawing, the stopper 54 is configured by a convex portion having a tapered surface (an inclined surface) that is inclined so as to descend from the proximal end side toward the distal end side.

As a result, the restoring force of the marker 8 a is prevented from acting on the graft 200 and the blood vessel wall 310, and the puncture portion 52 is difficult to come out of the blood vessel wall 310.
According to the pin 5 of the second embodiment, the same effect as that of the first embodiment described above can be obtained.
This second embodiment can also be applied to a third embodiment described later.

<Third Embodiment>
FIG. 11 is a side view showing a third embodiment of the pin of the present invention. In the following description, the lower side in FIG. 11 is referred to as a “tip” and the upper side is referred to as a “base end”. Further, in FIG. 11, the graft and the blood vessel wall are schematically shown.

  Hereinafter, the third embodiment will be described with a focus on differences from the first embodiment described above, and descriptions of the same matters will be omitted.

  As shown in FIG. 11, in the pin 5 of the third embodiment, the distal end fixing marker 55 having contrast properties in, for example, X-ray fluoroscopy (including CT scan), MRI, or the like is applied to the distal end 521 of the puncture unit 52. Is provided. Thereby, the tip fixed marker 55 can be visually recognized under X-ray fluoroscopy, MRI or the like (under contrast). In the following description, each of these perspectives is typically expressed as “under fluoroscopy”.

  In this embodiment, the distal end portion fixing marker 55 is formed on the outer peripheral surface of the puncture portion 52 over the entire circumference along the circumferential direction (having an annular shape). Further, a continuous surface without a step is formed before and after the distal end fixing marker 55 in the longitudinal direction of the puncture portion 52. Thereby, the marker 8a can be contracted smoothly.

  The distance between the distal end fixed marker 55 and the marker 8a contracted at the proximal end portion 522 of the puncture portion 52 is the penetration distance of the puncture portion 52 when the puncture portion 52 penetrates the graft and the blood vessel wall 310 ( This corresponds to the puncture depth. Therefore, the penetration distance of the puncture unit 52 can be grasped under fluoroscopy.

  As a constituent material of the tip fixing marker 55, for example, the same material as the marker 8a described above can be used.

Further, the contrast property of the distal-end fixed marker 55 and the marker 8 a may be the same or different, but the contrast property of the distal-end fixed marker 55 is contracted at the proximal end portion 522 of the puncture portion 52. It is preferably lower than the marker 8a. By making the contrast of the tip fixed marker 55 lower than that of the marker 8a, the tip fixed marker 55 and the marker 8a can be distinguished under fluoroscopy.
According to the pin 5 of the third embodiment, the same effect as that of the first embodiment described above can be obtained.

  In the present invention, in place of the distal end portion fixing marker 55, a proximal end portion fixing marker (not shown) may be provided at the proximal end portion 522 of the puncture portion 52, and the distal end portion fixing marker 55 and the proximal end portion may be provided. Both fixed markers may be provided. The contrast of the proximal fixed marker and the marker 8a may be the same or different, but the contrast of the proximal fixed marker is higher than that of the marker 8a contracted at the proximal end 522 of the puncture portion 52. Is preferably low.

<Fourth embodiment>
FIG. 12 is a side view showing a fourth embodiment of the pin of the present invention. In the following description, the lower side in FIG. 12 is referred to as “tip” and the upper side is referred to as “base end”. Further, in FIG. 12, the graft and the blood vessel wall are schematically shown.

  Hereinafter, the fourth embodiment will be described focusing on the differences from the first embodiment described above, and description of similar matters will be omitted.

  In the fourth embodiment, the pin 5 has a marker 8b formed of a movable body that can move in the longitudinal direction of the puncture portion 52 of the pin main body 50.

  That is, as shown in FIG. 12, the marker (moving body) 8b is installed on the puncture portion 52 of the pin body 50 so as to be movable along the longitudinal direction thereof.

  In this embodiment, the marker 8b has an annular shape, and the puncture portion 52 is inserted through the marker 8b. Further, the marker 8 b is held at the distal end portion 521 of the puncture portion 52.

  In addition, as a constituent material of the marker 8b, for example, the same material as that of the marker 8a described above can be used.

  In addition, a distal end fixing marker 55 having a contrast in X-ray fluoroscopy (including CT scan) or MRI is provided at the distal end 521 of the puncture unit 52. Thereby, the tip fixed marker 55 can be visually recognized under X-ray fluoroscopy, MRI or the like (under contrast). In the following description, each of these perspectives is typically expressed as “under fluoroscopy”.

  In this embodiment, the distal end fixed marker 55 is formed on the outer peripheral surface of the puncture portion 52 over the entire circumference along the circumferential direction (having an annular shape), and overlaps the marker 8b. Further, a continuous surface without a step is formed before and after the distal end fixing marker 55 in the longitudinal direction of the puncture portion 52. Thereby, the marker 8b can move smoothly.

  As a constituent material of the tip fixing marker 55, for example, the same material as the marker 8a described above can be used.

  Further, the contrast of the tip fixed marker 55 and the marker 8b may be the same or different, but the contrast of the tip fixed marker 55 is preferably lower than that of the marker 8b. By making the contrast of the tip fixed marker 55 lower than that of the marker 8b, the tip fixed marker 55 and the marker 8b can be distinguished under fluoroscopy.

  Before the puncture part 52 penetrates (grafts) the graft 200 and the blood vessel wall 310, the marker 8b is positioned on the distal end fixed marker 55, and only the marker 8b is visually recognized under X-ray fluoroscopy.

  When the puncture portion 52 penetrates the graft 200 and the blood vessel wall 310, the marker 8b comes into contact with the graft 200 (blood vessel wall 310), and only the puncture portion 52 moves in the distal direction, whereby the marker 8b is punctured. It moves in the proximal direction relative to the part 52. In a state where the puncture portion 52 has penetrated the graft 200 and the blood vessel wall 310, the distal end fixed marker 55 and the marker 8a are visually recognized under X-ray fluoroscopy. Thereby, it is possible to grasp that the puncture unit 52 has penetrated the graft 200 and the blood vessel wall 310.

Further, the distance between the distal end fixed marker 55 and the marker 8 b corresponds to the penetration distance (puncture depth) of the puncture portion 52 when the puncture portion 52 penetrates the graft and the blood vessel wall 310. Therefore, the penetration distance of the puncture unit 52 can be grasped under fluoroscopy.
According to the pin 5 of the fourth embodiment, the same effects as those of the first embodiment described above can be obtained.

<Fifth Embodiment>
FIG. 13 is a side view showing a fifth embodiment of the pin of the present invention. In the following description, the lower side in FIG. 13 is referred to as a “tip”, and the upper side is referred to as a “base end”. Further, in FIG. 13, the graft and the blood vessel wall are schematically shown.

  Hereinafter, the fifth embodiment will be described with a focus on differences from the above-described fourth embodiment, and description of similar matters will be omitted.

  As shown in FIG. 13, in the pin 5 of the fifth embodiment, the proximal end portion 522 of the puncture portion 52 is fixed to the proximal end portion having contrast properties under X-ray fluoroscopy (including CT scan) or MRI, for example. A marker 56 is provided. Thereby, the base end fixed marker 56 can be visually recognized under X-ray fluoroscopy, MRI or the like (under contrast). In the following description, each of these perspectives is typically expressed as “under fluoroscopy”.

  In the present embodiment, the proximal end fixed marker 56 is formed on the outer peripheral surface of the puncture portion 52 over the entire circumference along the circumferential direction (having an annular shape). Further, a continuous surface without a step is formed before and after the proximal end fixed marker 56 in the longitudinal direction of the puncture portion 52. Thereby, the marker 8b can move smoothly.

  As a constituent material of the tip fixing marker 55, for example, the same material as the marker 8a described above can be used.

  In addition, the contrast of the proximal end fixed marker 56 and the marker 8b may be the same or different, but the contrast of the proximal fixed marker 56 is preferably lower than that of the marker 8b. By making the contrast of the proximal end fixed marker 56 lower than that of the marker 8b, the proximal end fixed marker 56 and the marker 8b can be distinguished under fluoroscopy.

  Before the puncture part 52 penetrates (pierces) the graft 200 and the blood vessel wall 310, the proximal end fixed marker 56 and the marker 8b are visually recognized under fluoroscopy.

When the puncture portion 52 penetrates the graft 200 and the blood vessel wall 310, the marker 8b comes into contact with the graft 200 (blood vessel wall 310), and only the puncture portion 52 moves in the distal direction, whereby the marker 8b is punctured. It moves in the proximal direction relative to the part 52. In a state where the puncture portion 52 has penetrated the graft 200 and the blood vessel wall 310, the marker 8b is positioned on the proximal end fixed marker 56, and only the marker 8a is visible under fluoroscopy. Thereby, it is possible to grasp that the puncture unit 52 has penetrated the graft 200 and the blood vessel wall 310.
According to the pin 5 of the fifth embodiment, the same effects as those of the fourth embodiment described above can be obtained.

  In the present invention, both the distal end portion fixing marker 55 and the proximal end portion fixing marker 56 may be provided. It is preferable that the contrast property of the distal end fixed marker 55 and the proximal end fixed marker 56 is lower than that of the marker 8b.

  When both the distal end fixed marker 55 and the proximal end fixed marker 56 are provided, and the contrast of the distal end fixed marker 55 and the proximal end fixed marker 56 is lower than that of the marker 8b, the puncture unit 52 is grafted 200. Before penetrating the blood vessel wall 310, the marker 8b is positioned on the distal end fixed marker 55, and the proximal end fixed marker 56 and the marker 8b are visually recognized under fluoroscopy. In this case, the proximal end fixed marker 56 looks thin and the marker 8b looks dark.

  In the state where the puncture portion 52 has penetrated the graft 200 and the blood vessel wall 310, the marker 8b is positioned on the proximal end fixed marker 56, and the distal end fixed marker 55 and the marker 8b are respectively seen under fluoroscopy. , Visually recognized. In this case, the tip fixed marker 55 looks thin and the marker 8b looks dark. That is, the portion that appears thin and the portion that appears dark are reversed before and after the puncture portion 52 is penetrated.

  Thus, it can be visually recognized (confirmed) under fluoroscopy that the puncture unit 52 has penetrated the graft 200 and the blood vessel wall 310.

<Sixth Embodiment>
FIG. 14: is a side view which shows the principal part of 6th Embodiment of the pin of this invention. In the following description, the lower side in FIG. 14 is referred to as a “tip”, and the upper side is referred to as a “base end”.

  Hereinafter, the sixth embodiment will be described with a focus on differences from the above-described fourth embodiment, and description of similar matters will be omitted.

  As shown in FIG. 14, the pin 5 of the sixth embodiment has a holding portion (holding means) 57 that holds the marker 8 b at the distal end portion 521 of the puncture portion 52. The holding portion 57 includes a first stopper 571 and a second stopper 572 formed at the distal end portion 521 of the puncture portion 52.

  The first stopper 571 is disposed on the distal end side with respect to the marker 8b. In the illustrated configuration, the first stopper 571 is configured by a convex portion having a tapered surface (inclined surface) that is inclined from the proximal end side toward the distal end side. Has been. Thereby, it can prevent that the marker 8b detaches | leaves from the puncture part 52. FIG.

On the other hand, the second stopper 572 is disposed on the proximal end side with respect to the marker 8b, prevents movement of the marker 8b in the proximal direction, and the puncture portion 52 penetrates the graft 200 and the blood vessel wall 310. The marker 8b can be moved in the proximal direction. That is, in the illustrated configuration, the second stopper 572 is configured by a convex portion having a tapered surface (inclined surface) that is inclined from the proximal end side toward the distal end side.
According to the pin 5 of the sixth embodiment, the same effect as that of the fourth embodiment described above can be obtained.

And since the pin 5 of this 6th Embodiment has the holding | maintenance part 57, before use at the time of storage etc., the marker 8b is hold | maintained at the front-end | tip part 521 of the puncture part 52, and the puncture part 52 is used. Moves proximally as it penetrates the graft 200 and the vessel wall 310. That is, it is possible to prevent the marker 8b from being detached from the puncture portion 52 and malfunctioning (the marker 8b is erroneously moved in the proximal direction), and more reliably function as a marker. it can.
The sixth embodiment can also be applied to the fifth embodiment described above.

  The pin of the present invention has been described based on the illustrated embodiment. However, the present invention is not limited to this, and the configuration of each part may be replaced with an arbitrary configuration having the same function. Can do. In addition, any other component may be added to the present invention.

  Further, the present invention may be a combination of any two or more configurations (features) of the above embodiments.

  Further, the pin of the present invention is not limited to the one that fixes the graft to the blood vessel wall. In addition, for example, various indwelling objects such as a heart prosthetic valve (prosthetic heart valve), a stent graft, and a stent can be used in vivo. The present invention can be applied to a pin that is fixed to a living tissue at a site where there is a blood flow, and further to a pin that fixes an indwelling object to the living tissue in a living body regardless of the presence or absence of blood flow.

  Since the heart prosthetic valve is fixed at a location where the blood flow rate is high, it can be fixed securely by using the pin having the above-described configuration.

  For stent grafts, for example, when blood leaks from a part of the stent graft that is fixed to the blood vessel wall, the leakage of blood can be eliminated by fixing the leaking part with a pin. Can do.

  Further, each of the stent graft and the stent can be more reliably fixed by further fixing with a pin.

It is a side view which shows embodiment of the pin driving device used when fixing a graft with the pin shown in FIG. It is a figure which shows the pin driving device shown in FIG. It is a side view which shows 1st Embodiment of the pin of this invention. FIG. 4 is a cross-sectional view showing a state in which a graft inserted and placed near a blood vessel aneurysm is fixed to a blood vessel wall with a pin shown in FIG. 3. It is sectional drawing for demonstrating an effect | action of the pin driving device shown in FIG. It is sectional drawing for demonstrating an effect | action of the pin driving device shown in FIG. It is sectional drawing for demonstrating an effect | action of the pin driving device shown in FIG. It is sectional drawing for demonstrating an effect | action of the pin driving device shown in FIG. It is sectional drawing for demonstrating an effect | action of the pin driving device shown in FIG. It is a side view which shows 2nd Embodiment of the pin of this invention. It is a side view which shows 3rd Embodiment of the pin of this invention. It is a side view which shows 4th Embodiment of the pin of this invention. It is a side view which shows 5th Embodiment of the pin of this invention. It is a side view which shows the principal part of 6th Embodiment of the pin of this invention.

Explanation of symbols

DESCRIPTION OF SYMBOLS 1 Pin driving device 10 Main body part 2 Outer cylinder 21 Opening 22 Lumen 23 Central axis 3 Inner cylinder 31 Opening 32 Contact part 33 Storage part 34 Gripping part 4 Pusher 41 Gripping part 5 Pin 50 Pin main body 51 Head 510 Axis 511 Distal end portion 512 proximal end portion 52 puncture portion 520 shaft 521 distal end portion 522 proximal end portion 53 spine portion 531 distal end portion 54 stopper 55 distal end portion fixing marker 56 proximal end portion fixing marker 57 holding portion 571 first stopper 572 second stopper 6 Balloon 7 Hub 71, 72 Port 8a, 8b Marker 81 Tip portion 82 Base end portion 200 Graft 300 Blood vessel 310 Blood vessel wall 320 Aneurysm 400 Syringe

Claims (14)

A pin for fixing an indwelling object to a living tissue in a living body,
A pin body having a stick-like puncture portion that is punctured into a living tissue together with the indwelling object;
A pin that is provided on the puncture portion and includes a marker having a contrast property that is deformable or movable in a longitudinal direction of the puncture portion.   The pin according to claim 1, wherein the marker is a variable shape body that is installed to be extendable and contractable in a longitudinal direction of the puncture portion.   One end portion of the shape variable body is located at a distal end portion of the puncture portion, and when the puncture portion punctures a biological tissue, the shape variable body moves toward a proximal end, and thereby the shape variable body contracts. The pin according to claim 2, which is configured as follows.   The pin according to claim 2 or 3, wherein the shape variable body is configured by a coiled wire wound around the puncture portion.   The pin according to claim 1, wherein the marker is a moving body that is movably installed along a longitudinal direction of the puncture unit.   The pin according to claim 5, wherein the moving body has an annular shape, and the puncture portion is inserted through the moving body.   The pin according to claim 5 or 6, wherein the movable body is held at a distal end portion of the puncture portion.   The pin according to any one of claims 5 to 7, further comprising holding means having a first stopper for preventing the moving body from being detached from the puncture portion.   The holding means prevents a movement of the movable body in the proximal direction, and a second stopper that enables the movable body to move in the proximal direction when the puncture portion punctures a living tissue. The pin according to claim 8.   The pin according to any one of claims 1 to 9, wherein a distal end fixing marker having a contrast property is provided at a distal end portion of the puncture portion.   The pin according to claim 10, wherein the tip fixed marker has a lower contrast than the marker.   The pin according to any one of claims 1 to 11, wherein a proximal end fixed marker having contrast is provided at a proximal end of the puncture portion.   The pin according to claim 12, wherein the proximal end fixed marker is lower in contrast than the marker. The pin body has a substantially straight head,
A portion extending from the head and projecting, having a portion that comes into contact with the indwelling object, and a spine for closely attaching the indwelling object to a living tissue,
The puncture portion extends from the head and protrudes so that the angle θ between the axis of the puncture portion and the axis of the head is less than 90 °. The pin according to claim 1, which is inclined with respect to the pin.

Images