JP2012065933A - Stent graft and stent graft system to deliver the stent graft into body - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a stent graft and a stent graft system to deliver the stent graft into the body for cutting or damaging the desired body tissue with a simple procedure, thereby blocking the function.SOLUTION: The stent graft system 12 includes: the stent graft 10 having a blade 22 capable of stabbing in the body tissue on an outer surface of a tube member 30 where a stent 28 is fixed on the tubular graft 26; a sheath 24 which can store the stent graft 10 in an inner cavity; and an expanding-amount adjustment mechanism 49 which can expand the stent graft 10 stored in the sheath 24 in a phased manner. It also has a delivery device 20 to deliver the stent graft 10 into a body cavity.

Description

  The present invention relates to a stent graft that is placed in a body cavity to disable a desired biological tissue, and a stent graft system that delivers the stent graft into the body.

  For example, for patients with refractory hypertension where it is difficult to improve hypertension even after taking anti-pressure agents, blood pressure can be reduced by cutting the sympathetic nerve around the renal artery and blocking its transmission There is knowledge.

  As a technique for percutaneously cutting the sympathetic nerve of the renal artery, an ablation catheter is generally used. For example, Patent Document 1 discloses a catheter capable of applying electroporation or electrofusion to a nerve by a pulse output electric field generator as an ablation catheter for cutting the sympathetic nerve around the renal artery. .

Special table 2008-515544 gazette

  However, in the procedure using the ablation catheter as described above, it is difficult to confirm whether or not nerve cauterization has been performed, and the inner wall of the renal artery is changed to a predetermined portion while changing the position of the catheter. It is necessary to cauterize one by one, and the procedure is difficult and the patient burden is appropriate.

  The present invention has been made in consideration of such problems of the prior art, and a stent graft capable of cutting or damaging a desired living tissue with a simple technique and blocking the function thereof is provided inside the body. It is an object to provide a stent graft system for delivery.

  The stent graft according to the present invention is characterized in that a piercing member capable of piercing a living tissue is provided on the outer surface of a cylindrical portion in which a metal skeleton is fixed to a tube-shaped graft.

  According to such a configuration, by providing a piercing member on the outer surface of the cylindrical portion to configure the stent graft, for example, by delivering and deploying the stent graft into the renal artery, the sympathy around the renal artery The nerve can be pierced by the piercing member together with the blood vessel wall. Therefore, the sympathetic nerve can be easily cut or damaged by a simple procedure, and the transmission function can be blocked. Furthermore, by deploying the stent graft toward the stenosis portion formed on the inner wall of the blood vessel, the stenosis member can be pierced and cut into the stenosis portion to easily expand the stenosis portion. At this time, the damaged biological tissue (biological lumen tissue) is indwelled with a cylindrical portion having a metal skeleton fixed to the graft, so that the damaged biological tissue can be repaired at the same time, and blood leakage and the like are prevented. be able to.

  In this case, the piercing member may be a blade capable of cutting the living tissue or a needle capable of piercing the living tissue.

  If the piercing member can be pierced into the living tissue in a direction outward in the radial direction of the cylindrical portion, for example, the piercing member can be pierced easily and reliably into a blood vessel wall or the like.

  When the piercing member can be changed from a stowed posture folded along the axial direction of the cylindrical portion to a piercing posture standing up in the radial direction of the cylindrical portion, the stent posture determines the stent graft according to the stowed posture. It can be easily housed in the sheath of the delivery device and delivered into the body, and after delivery, the living tissue can be pierced easily and reliably by the piercing posture.

  When a plurality of the piercing members are provided in the circumferential direction of the cylindrical portion, for example, the sympathetic nerve around the blood vessel can be cut or damaged with high probability.

  Furthermore, the piercing member includes a plurality of pairs arranged at predetermined intervals in the circumferential direction of the cylindrical portion, and provided in a plurality of rows along the axial direction of the cylindrical portion, and in the circumferential direction of the piercing member of each set. If the phases are shifted from each other in each row, it is possible to reliably cut or damage the desired sympathetic nerve or the like while preventing the blood vessel or the like from being completely cut at one place in the circumferential direction.

  When the piercing member is disposed at a position including the axial center of the cylindrical portion, the living tissue can be cut at a substantially central position of the cylindrical portion, and the cutting position can be ensured with the entire length of the cylindrical portion. Since it can cover, repair of the cut blood vessel etc. can be performed more reliably.

  When the distal end and the proximal end of the cylindrical portion are each provided with a locking tool for positioning and holding the stent graft in the body cavity, the positioning and fixing of the stent graft in the body can be performed more reliably.

  The biological tissue may be a renal artery and a nerve around the renal artery. The puncture member may be coated with a drug that blocks transmission of the nerve or inhibits regeneration of the nerve.

  The stent graft system according to the present invention includes a stent graft provided with a piercing member capable of piercing a living tissue on an outer surface of a cylindrical portion in which a metal skeleton is fixed to a tubular graft, and the stent graft can be accommodated in a lumen. It has a deployment amount adjusting mechanism capable of deploying the stent graft accommodated in the sheath in stages, and a delivery device for delivering the stent graft into a body cavity.

  According to such a configuration, a stent graft provided with a piercing member on the outer surface of the cylindrical portion can be reliably delivered into a desired body cavity by the delivery device. Moreover, the delivery device is provided with a deployment amount adjusting mechanism capable of deploying the stent graft accommodated in the sheath in stages, thereby preventing the entire stent graft from being deployed at once. Thereby, for example, by extending the distal end side to the piercing member in a state where the proximal end side of the stent graft is held by the sheath, the piercing member can be reliably pierced into the living tissue.

  The sheath may include at least two layers, and the delivery device may include the deployment amount adjusting mechanism capable of deploying the stent graft stepwise by retracting the sheath of each layer individually.

  In this case, the piercing member is disposed at a position including the axial center of the cylindrical portion, and the sheath includes an outer layer first sheath, an intermediate layer second sheath, and an inner layer third sheath, The stent graft is configured such that the distal end side is accommodated in the lumen of the first sheath, the blade is accommodated in the lumen of the second sheath, and the proximal end side is accommodated in the lumen of the third sheath. There may be.

  The delivery device may include the deployment amount adjusting mechanism capable of deploying the stent graft stepwise by retracting the sheath every predetermined distance in the axial direction.

  According to the present invention, by providing a puncture member on the outer surface of the cylindrical portion to constitute a stent graft, for example, by delivering and deploying the stent graft into the renal artery, the sympathetic nerve around the renal artery is The blood vessel wall can be pierced by the piercing member. Therefore, the sympathetic nerve can be easily cut or damaged by a simple procedure, and the transmission function can be blocked. Furthermore, by deploying the stent graft toward the stenosis portion formed on the inner wall of the blood vessel, the stenosis member can be pierced and cut into the stenosis portion to easily expand the stenosis portion.

1 is an overall configuration diagram of a stent graft system that is a medical instrument that includes a stent graft according to an embodiment of the present invention and places the stent graft in the body. 2A is a partially omitted side sectional view of the stent graft system shown in FIG. 1, and FIG. 2B is an enlarged side sectional view of the distal end side of the stent graft system shown in FIG. 2A. It is a top view of the operation part periphery of the stent graft system shown in FIG. FIG. 4A is a side view of the blade in a folded state, and FIG. 4B is a side view of the blade in an upright state. 5A is a partially omitted side sectional view of the stent graft system with the outer sheath retracted from the state shown in FIG. 2A, and FIG. 5B is an enlarged side sectional view of the distal end side of the stent graft system shown in FIG. 5A. It is. 6A is a partially omitted side sectional view of the stent graft system in a state where the intermediate sheath is retracted from the state shown in FIG. 5A, and FIG. 6B is an enlarged side sectional view of the distal end side of the stent graft system shown in FIG. 6A. It is. 7A is a partially omitted side sectional view of the stent graft system with the inner sheath retracted from the state shown in FIG. 6A, and FIG. 7B is an enlarged side sectional view of the distal end side of the stent graft system shown in FIG. 7A. It is. FIG. 7B is a partially omitted side cross-sectional view of the stent graft expanded with a balloon catheter from the state shown in FIG. 7B. It is explanatory drawing in the direction orthogonal to the axial direction for demonstrating the state in which the blade of a stent graft pierces a blood vessel wall. 10A is a partially omitted side view of a stent graft according to a configuration example using a needle instead of a blade, and FIG. 10B is a partially omitted side view in a state where the needle is raised from the state shown in FIG. 10A. is there. FIG. 11A is a partially omitted side sectional view of the stent graft system to which the delivery device according to the first modification is applied, and FIG. 11B is a plan view of the periphery of the operation portion of the stent graft system shown in FIG. 11A. 12A is a partially omitted side cross-sectional view of a stent graft system to which a delivery device according to a second modification is applied, and FIG. 12B is a plan view of the periphery of an operation unit of the stent graft system shown in FIG. 12A. 13A is a partially omitted side cross-sectional view of the outer sheath retracted from the state shown in FIG. 12A, and FIG. 13B is a plan view of the periphery of the operation portion of the stent graft system shown in FIG. 13A.

  Hereinafter, preferred embodiments of the stent graft according to the present invention will be described in relation to a stent graft system including a delivery device for delivering the stent graft into the body, with reference to the accompanying drawings.

  FIG. 1 is an overall configuration diagram of a stent graft system 12 (hereinafter also simply referred to as “system 12”), which is a medical instrument that includes a stent graft 10 according to an embodiment of the present invention and places the stent graft 10 in the body. . 2A is a partially omitted side sectional view of the stent graft system 12 shown in FIG. 1, and FIG. 2B is an enlarged side sectional view of the distal end side of the stent graft system 12 shown in FIG. 2A.

  The system 12 according to the present embodiment treats hypertension by, for example, cutting or damaging the sympathetic nerve 18 around the renal artery 16 leading to the kidney 14 and blocking (blocking, disabling) its transmission function. It is a medical instrument. That is, the system 12 delivers and deploys the stent graft 10 into the renal artery 16 by the delivery device 20 and destroys the sympathetic nerve 18 by piercing the renal artery 16 with a blade 22 provided on the outer peripheral surface of the stent graft 10. Is.

  As shown in FIGS. 1, 2A and 2B, the system 12 delivers a stent graft 10 with a blade 22 on its outer peripheral surface and delivers the stent graft 10 into the body (eg, into the renal artery 16) by a long sheath 24. And a delivery device 20. 1 and 2A, the right side (hub 25 side) of the sheath 24 is the “proximal end (rear end, proximal)” side, and the left side of the sheath 24 (the stent graft 10 side) is the “tip (distal)” side. Call and explain.

  First, the stent graft 10 will be described.

  As shown in FIG. 2B, the stent graft 10 includes a cylindrical portion 30 in which a stent 28 that is a metal skeleton for expansion is fixed to an inner surface or an outer surface of a tubular graft 26, and an outer periphery at a position including the axial center of the cylindrical portion 30. A plurality of blades 22 (see FIGS. 4A, 4B, and 8) provided on the surface and standing when the cylindrical portion 30 is deployed are provided.

  The cylindrical portion 30 has substantially the same configuration as a general stent graft. For example, the graft 26 is configured by forming a woven fabric (fabric) woven with resin threads such as PTFE, ePTFE (expanded polytetrafluoroethylene), and polyester into a tube shape, and the stent 28 is made of a superelastic alloy or the like. The self-expanding performance is achieved by forming the wire to be formed into a Z shape or a ring shape, or by forming a pipe made of a superelastic alloy by laser cutting. A swellable gel or the like may be applied to the outer surface of the graft 26, that is, the portion in contact with the blood vessel wall in order to prevent blood leakage.

  Examples of the superelastic alloy forming the stent 28 include Ti—Ni alloy, Ti—Ni—Fe alloy, Cu—Zn alloy, Cu—Zn—Al alloy, Cu—Al—Ni alloy, Cu— Examples thereof include an Au—Zn alloy, a Cu—Sn alloy, a Ni—Al alloy, an Ag—Cd alloy, an Au—Cd alloy, an In—Ti alloy, and an In—Cd alloy.

  A plurality of (four in this embodiment) hooks (locking tools, anchors) 31 are provided at both ends of the cylindrical portion 30 along the circumferential direction. The hook 31 is, for example, substantially U-shaped, and has a pair of barbs 31a and 31a that are bent and protruded outward at the tip thereof and directed in the tip direction. Since the barb 31a of the hook 31 is hard to be inserted into the inner wall of the blood vessel when the stent graft 10 is used, the stent graft 10 is prevented from flowing with respect to blood flow, and the stent graft 10 can be positioned and held more reliably in the blood vessel.

  As shown in FIGS. 2B, 4A, and 4B, the blades 22 are arranged in a plurality of annular shapes in the circumferential direction and in a plurality of rows in the axial direction in the vicinity of the center in the axial direction of the cylindrical portion 30. The blade 22 is fixed to the surface of the graft 26 by adhesion or stitching, and is bent from one end of the base 22a, and is in a storage posture (see FIG. 4A) parallel to the base 22a at approximately 0 °. The blade portion 22b can be changed to a piercing posture (see FIG. 4B) that stands upright at approximately 90 °. The blade 22 may be produced by partially bending the stent 28 outward.

  That is, the blade 22 is housed in the sheath 24, so that the blade 22 b is folded in the rearward direction along the axial direction of the cylindrical portion 30, and the sheath 24 is removed and the cylindrical portion 30 is removed. As it expands, the piercing posture is such that the blade portion 22b stands in the radial direction of the cylindrical portion 30. The blade 22 is folded in the retracted position so that the blade portion 22b faces rearward, whereby the blade portion 22b is prevented from being cut into the inner surface of the middle sheath 24b when the middle sheath 24b described later is pulled backward. The sheath 24b can be removed smoothly.

  The blade 22 (blade portion 22b) may be formed of a biocompatible metal material such as stainless steel or cobalt chrome, and is formed of a biodegradable metal or polymer material such as magnesium, polylactic acid, or polyglycolic acid. May be.

  In the case of this embodiment, as shown in FIGS. 2B and 8, the arrangement of the blades 22 is a first in which a plurality of blades 22 (for example, about 4 to 16 blades) are arranged at equal intervals in the circumferential direction of the cylindrical portion 30. A third set 32a, a second set 32b arranged behind the first set 32a with the same configuration as the first set 32a, and a third set arranged behind the second set 32b with the same configuration as the first set 32a The set 32c is a ring structure in the circumferential direction and a multi-row (for example, about 2 to 5 rows) structure in the axial direction, and the phase in the circumferential direction of each set 32a to 32c is at least between adjacent sets. It is preferable that it is shifted.

  Therefore, when the cylindrical portion 30 is viewed in a direction orthogonal to the axial direction (see FIGS. 2B, 8 and 9), each of the second sets 32b is formed in a gap between the blades 22 of the first set 32a. The blades 22 are arranged, and further, the respective blades 22 constituting the third set 32c are arranged in the gaps between the respective blades 22 constituting the second set 32b. The blades 22 may have a structure other than the above-described three-row structure, for example, one row, two rows, or four or more rows. Further, the number of blades 22 constituting each group is appropriately determined depending on the specifications of the stent graft 10 and the like. It can be changed.

  In such a stent graft 10, for example, the cylindrical portion 30 is formed as a tube having an inner diameter of about 3 mm to 10 mm and a length of about 10 mm to 30 mm, and the blade 22 has a length (height) of the blade portion 22b of 3 mm. It is formed in a thin plate shape having a width (circumferential width) of about 0.5 mm to 3 mm.

  Next, the delivery device 20 will be described.

  As shown in FIG. 1 and FIG. 2A, the delivery device 20 is provided with a thin and long sheath 24, a shaft (inner tube) 36 disposed in the lumen of the sheath 24, and the distal end of the shaft 36. And a hub 25 provided on the base end side of the operation portion 40. The operation portion 40 is provided on the base end side of the shaft 36 and accommodates the base end portion of the sheath 24 so as to be able to advance and retreat.

  The shaft 36 is a thin and long tube having a lumen 36a through which a guide wire (not shown) is inserted, and connects between the hub 25 and the tip tip 38. The lumen 36 a communicates from the distal end surface of the distal end tip 38 to the hub 25, and is opened by a luer taper 25 a provided on the proximal end surface of the hub 25.

  The sheath 24 has a three-layer structure composed of an outer sheath (first sheath) 24a as an outermost layer, an intermediate sheath (second sheath) 24b as an intermediate layer, and an inner sheath (third sheath) 24c as an innermost layer. Thus, the sheaths 24a to 24c of each layer can be independently advanced and retracted in the axial direction. The base end portions of the sheaths 24 a to 24 c are disposed in an annular space 44 formed in the operation unit 40. At the base ends of the respective sheaths 24 a to 24 c, operation pins 46 a to 46 c that protrude in the radial direction perpendicular to the axial direction are provided, and these operation pins 46 a to 46 c are provided on one side surface of the operation unit 40. It passes through the slit 48 formed with an opening and protrudes to the outside.

  In the case of this embodiment, the lengths of the sheaths 24a to 24c are substantially the same, but as shown in FIGS. 2A and 2B, the initial state in which the stent graft 10 is completely stored in the lumen (before insertion into the body) In the preparatory state), the axial positions of the sheaths 24a to 24c are shifted by substantially equal intervals, and the axial positions of the operation pins 46a to 46c protruding from the slit 48 are also shifted by approximately equal intervals.

  As shown in FIGS. 2A and 2B, in the initial state, the outer sheath 24a that protrudes toward the distal end and is in contact with (adjacent to) the distal tip 38 stores and holds the distal end portion of the stent graft 10. The intermediate sheath 24b accommodates and holds the intermediate portion including the blade 22 of the stent graft 10, and the proximal inner sheath 24c accommodates and holds the proximal end portion of the stent graft 10. In this state, the operation pin 46a is in contact with or close to the tip edge portion of the slit 48, and a gap of the same degree as the interval between the operation pins is formed behind the operation pin 46c.

  The operation unit 40 is fixed to the distal end side of the hub 25, and the shaft 36 is inserted and fixed at the center of the operation unit 40. Have. The distal end side of the space 44 is open so that the sheaths 24 a to 24 c can be inserted, and the proximal end side is closed at substantially the same position as the proximal end side edge of the slit 48 in the axial direction. The slit 48 is a long hole that communicates the outer surface of the housing of the operation unit 40 and the space 44, and has a shape that is long in the axial direction and narrow in the circumferential direction (see FIGS. 2A and 3).

  As described above, in the delivery device 20, the operation unit 40 and the hub 25 are fixed, and the shaft 36 is also inserted and fixed thereto. Therefore, as shown in FIGS. 2A, 5A, 6A, and 7A, when the operator holds the operation portion 40 (hub 25) and moves the operation pins 46a to 46c forward and backward, the outer sheath 24a is moved. The inner sheath 24b slides on the outer peripheral surface of the inner sheath 24c, the inner sheath 24c slides on the outer peripheral surface of the shaft 36 and the inner wall surface of the space 44, Each sheath 24a-24c can be driven forward or backward independently or simultaneously.

  Therefore, when the sheaths 24a to 24c are sequentially retracted, the portions of the stent graft 10 accommodated and held in the lumens of the sheaths 24a to 24c can be deployed in the body cavity step by step. That is, the sheath 24 (sheaths 24 a to 24 c) and the operation unit 40 constitute a deployment amount adjustment mechanism (multistage adjustment mechanism) 49 that can deploy the stent graft 10 accommodated in the sheath 24 in stages.

  In the delivery device 20, in order to visually recognize the position of the sheath 24 and the like of the delivery device 20 under X-ray fluoroscopy, for example, as shown in FIG. 2B, an X-ray opaque marker M1 may be provided at the distal end of the outer sheath 24a. Good. The radiopaque marker M1 is formed of a material (radiopaque material) having radiopacity made of gold, platinum, tungsten, or the like, and the tip position of the sheath 24 is set to X in the living body. It is for visual recognition under line contrast.

  As shown in FIG. 2B, for the stent graft 10, for example, by providing an X-ray opaque marker M <b> 2 at the distal end and the proximal end and the front and rear positions of the blade 22, the position of the stent graft 10 in the body and the blade 22. Can be reliably imaged under fluoroscopy. The radiopaque marker M2 can be easily installed by bonding or stitching a material such as an X-ray (radiation) opaque thread made of gold, platinum, tungsten or the like to the graft 26. Can do. Furthermore, as shown in FIGS. 4A and 4B, an X-ray opaque marker M3 may be provided at the tip of the blade portion 22b, whereby the exact position of the blade portion 22b can be grasped, and the stent graft 10 More accurate positioning is possible. For simplification of the drawings, the radiopaque markers M1 and M2 are illustrated only in FIG. 2B, the radiopaque markers M3 are illustrated only in FIGS. 4A and 4B, and are omitted in other drawings. is doing.

  In addition, the shaft 36 and the sheaths 24a to 24c can be inserted into the blood vessel smoothly while the operator grasps and operates the proximal end side. It is preferable to have flexibility and moderate strength (roughness, rigidity). Therefore, the shaft 36 and the sheaths 24a to 24c are made of, for example, a polymer material such as polyolefin, polyvinyl chloride, polyamide, polyamide elastomer, polyurethane, polyurethane elastomer, polyimide, fluororesin, or a mixture thereof, or two or more kinds of the above. It may be formed of a polymer material multilayer tube or the like.

  Next, the operation of the stent graft 10 and the stent graft system 12 according to this embodiment configured as described above will be described.

  The stent graft system 12 is used, for example, for a patient with refractory hypertension whose blood pressure does not decrease even when an anti-pressure drug is taken, and the sympathetic nerve 18 is transmitted by cutting the sympathetic nerve 18 around the renal artery 16. Used in treatments that block function and aim to lower blood pressure.

  First, a guide wire and a guiding catheter (not shown) are inserted from the femoral artery into the renal artery 16 for cutting the sympathetic nerve 18 in substantially the same manner as a procedure for placing a general stent in the renal artery. Then, the contrast is performed to reach the renal artery 16. Subsequently, a sheath 24 (see FIGS. 2A and 2B) containing the stent graft 10 on the distal end side is inserted into the body through the lumen of the guiding catheter, and the guide wire is inserted into the shaft 36 under X-ray fluoroscopy. Ascending while passing through the lumen 36 a, the center (blade 22) of the stent graft 10 accommodated in the sheath 24 reaches a position near the center of the renal artery 16.

  Next, the stent graft 10 is deployed in the renal artery 16 and a procedure for cutting the sympathetic nerve 18 with the blade 22 is performed.

  First, from the initial state shown in FIGS. 2A and 2B, the operation pin 46a of the first outer sheath 24a is pulled to a position where it abuts on the rear operation pin 46b, and the outer sheath 24a is retracted. As a result, as shown in FIGS. 5A and 5B, the distal end portion of the stent graft 10 is exposed in the renal artery 16, and this distal end portion is expanded and deployed to some extent by the stent 28. It is caught on the inner wall of the renal artery 16.

  Therefore, after confirming that the distal end side of the stent graft 10 is positioned and held at a desired position under fluoroscopy, the operation pin 46b of the second-layer inner sheath 24b is pulled backward together with the operation pin 46a, and the operation pin 46b is retracted to a position where it abuts against the operation pin 46c. 6A and 6B, most of the distal end side including the blade 22 of the stent graft 10 is exposed and deployed in the renal artery 16.

  In this state, as is understood from FIGS. 6A and 6B, the proximal end side of the stent graft 10 is housed in the inner sheath 24c. For this reason, the stent graft 10 is in a state of being expanded in a tapered shape inclined from the distal end side toward the proximal end side (see FIG. 6B), that is, the blade 22 is in a position where it does not contact the inner wall of the renal artery 16. Is completely upright. In other words, if the stent graft 10 is deployed from the distal end to the proximal end all at once, the blade portion 22b is pressed against the inner wall of the blood vessel while being folded, and the blade portion 22b can be completely raised. Although it may become difficult, in the case of this embodiment, the blade part 22b can be reliably stood up by expanding the stent graft 10 in steps.

  Subsequently, after confirming that the blade 22 is exposed in the renal artery 16 under X-ray fluoroscopy and is in a standing posture, the operation pin 46c of the third-layer inner sheath 24c is moved to the operation pin 46a, The operation pin 46c is pulled rearward together with 46b and retracted to a position where the operation pin 46c contacts the base end edge of the slit 48. As a result, as shown in FIGS. 7A and 7B, the entire stent graft 10 is deployed in the renal artery 16, and the hook 31 on the proximal end side is caught on the inner wall of the renal artery 16, so that the stent graft 10 is securely inserted into the blood vessel. The positioning is maintained.

  However, in this state, since the stent graft 10 is in an expanded state only by the expansion force of the stent 28, the tip of the blade portion 22b can completely penetrate the inner wall of the renal artery 16 as shown in FIG. 7B. Therefore, the cylindrical portion 30 is not completely expanded, and there is a possibility that the center portion has a slightly depressed shape.

  Therefore, next, as shown in FIG. 8, a predetermined balloon catheter 50 is inserted inside the stent graft 10, and the balloon 50 a is expanded to bring the stent graft 10 into close contact with the inner wall of the renal artery 16. As a result, the blade 22 (blade portion 22b) is completely pierced into the renal artery 16, and, for example, the outer membrane 16a, the media 16b and the outer membrane 16c of the renal artery 16 are, for example, the outer membrane as shown in FIG. The blade portion 22b can cut the sympathetic nerve 18 inside the outer periphery 16c or the outer peripheral side of the outer membrane 16c with certainty, and the transmission function can be cut off. After that, after confirming that there is no blood leakage from the renal artery 16, the delivery device 20 is removed, and the wound can be closed at the insertion site of the thigh.

  As described above, in the stent graft 10 according to the present embodiment, the blade 22 which is a piercing member capable of piercing a living tissue (blood vessel and surrounding nerve) on the outer surface of the cylindrical portion 30 constituted by the graft 26 and the stent 28. Is provided. Thereby, for example, by deploying the cylindrical portion 30 in the renal artery 16, the blade 22 stands up and pierces the inner wall of the renal artery 16, appropriately cuts the sympathetic nerve 18, and blocks its transmission function, Can treat high blood pressure.

  At this time, in the stent graft 10, the blood vessel wall is cut and damaged by the blade 22. As understood from FIG. 8 and the like, the damaged blood vessel has the same configuration as a general stent graft. Since the cylindrical portion 30 is indwelled, leakage of blood from the damaged blood vessel is surely prevented by the graft 36 constituting the cylindrical portion 30. That is, in the stent graft 10, the sympathetic nerve 18 can be cut and the blood vessel repair (stent graft placement) can be performed simultaneously.

  In the stent graft 10, the blade 22 is disposed at a position including the axial center of the cylindrical portion 30, and is not disposed in a predetermined range on the distal end side and the proximal end side of the cylindrical portion 30. Thereby, since the biological tissue can be cut at the substantially central position of the cylindrical portion 30 and the cutting position can be reliably covered with the entire length of the cylindrical portion 30, the cut blood vessel can be repaired more reliably. Can do.

  The blade 22 protrudes outward in the radial direction of the cylindrical portion 30, so that when the cylindrical portion 30 is expanded, a biological tissue (for example, a blood vessel wall or a nerve) on the outer peripheral side is highly probable. Can be pierced, cut or damaged. Moreover, as shown in FIGS. 4A and 4B, the blade 22 is pierced upright in the radial direction of the cylindrical portion 30 in order to cut the living tissue from the storage posture folded along the axial direction of the cylindrical portion 30. Can change to posture. For this reason, by retracting the cylindrical portion 30 and bringing the blade 22 into the storage position, it can be easily stored in a desired insertion tool (sheath 24 in the above), and easily delivered to a desired site in the body. can do.

  In the stent graft 10, as described above, a set (first set 32 a to third set 32 c) in which a plurality of blades 22 are installed at predetermined intervals in the circumferential direction of the cylindrical portion 30 is aligned in the axial direction of the cylindrical portion 30. A plurality of rows are provided, and the phase in the circumferential direction of each pair of blades 22 is shifted in each row. As a result, a predetermined interval can be provided between the blades 22 constituting each set, and the blood vessel wall can be prevented from being completely cut at one place in the circumferential direction and can be extended along the blood vessel. The sympathetic nerve 18 can be surely cut by the blades 22 in each row (see FIGS. 8 and 9). Of course, the arrangement of the blades 22 may be other than the configuration in which a plurality of sets are arranged in a plurality of rows as described above. For example, a spiral direction in which the outer peripheral surface of the cylindrical portion 30 is swung along the axial direction of the cylindrical portion 30. The blades 22 may be arranged in a row.

  Note that the piercing member for piercing a living tissue such as a blood vessel may be other than the blade 22 (blade portion 22b) having a predetermined width as described above. For example, as shown in FIGS. 10A and 10B Alternatively, the stent graft 10a may be configured using a needle 52 having a needle portion 52b that can be folded and stored with respect to the base 52a. The needle 52 has a sharp needle portion 52b instead of the blade portion 22b of the blade 22, for example.

  According to the needle 52, the function of cutting a biological tissue such as a blood vessel is reduced as compared with the case of the blade 22, and thus blood vessel damage and blood leakage after treatment can be reduced. There is a possibility that the sympathetic nerve 18 cannot be cut reliably. Therefore, it is also effective to apply a drug 53 (nerve blocking drug) for blocking (destroying) the transmission function of the sympathetic nerve 18 to the needle portion 52b (see FIG. 10B). Then, the drug 53 can be reliably delivered to a desired site from the pierced needle portion 52b.

  Examples of the drug 53 include dibucaine, mycophenolic acid, glycerin, alcohol, neurotoxin and the like. Of course, if these drugs are applied to the blade 22b of the blade 22, the nerve can be blocked more reliably. In FIG. 10B, for simplicity of illustration, the drug 53 is shown only on a part of the needles 52, but the drug 53 may of course be applied to all the needles 52.

  In the stent graft system 12, the sheath 24 that houses the stent graft 10 is configured by three-layered sheaths 24 a to 24 c, and the operation pins 46 a to 46 c are appropriately operated by the operation unit 40, whereby each sheath 24 a to 24 c is stepped. And a deployment amount adjusting mechanism 49 capable of deploying the stent graft 10 stepwise in the body.

  Therefore, it is possible to prevent the stent graft 10 from being expanded at once in the body. For example, first, the portion up to the blade 22 can be deployed by removing the inner sheath 24b in a state where the outer sheath 24a is removed and the hook 31 on the distal end side is hooked and positioned on the inner wall of the blood vessel. At this time, since the proximal end side of the cylindrical portion 30 is housed in the inner sheath 24c, as shown in FIG. 6B, the cylindrical portion 30 can be expanded in a tapered shape, and the blade portion 22b is formed on the inner wall of the blood vessel. The blade portion 22b can be reliably erected in a state in which the blade portion 22b does not abut, and the blade portion 22b can be reliably pierced into the blood vessel inner wall in the vertical direction by removing the next inner sheath 24c. For this reason, it can prevent that the blade part 22b contact | abuts to the blood vessel inner wall in the state which is not expand | deployed completely, and can pierce the blade part 22b to a biological tissue more reliably.

  In this case, the deployment amount adjustment mechanism in the delivery device 20 may be other than the configuration in which the sheath 24 is configured with three layers and the sheaths 24a to 24c are removed stepwise as in the deployment amount adjustment mechanism 49. Good. For example, the sheath 24 is composed of only two layers of the outer sheath 24a and the inner sheath 24c, and when the outer sheath 24a is removed, the state shown in FIGS. 2A and 2B to the state shown in FIGS. 6A and 6B (up to the blade 22) Even when configured to be in a state of being expanded, it is possible to obtain substantially the same operational effects as the above-described three-layer sheath.

  As shown in FIGS. 11A and 11B, the stent graft system 12a may include a delivery device 20a having a deployment amount adjustment mechanism (multistage adjustment mechanism) 49a in which the sheath 24 has only one layer of the outer sheath 24a.

  The delivery device 20a has an operation portion 40a that houses the proximal end side of the outer sheath 24a, and the operation portion 40a is formed with a slit 48a that is substantially similar to the operation portion 40 described above. Three marks 54a to 54c are printed or engraved at predetermined intervals on the outer surface of the housing of the operation unit 40a around the slit 48a. For example, a numeral “ “1”, “2”, and “3” are assigned.

  In the delivery device 20a, the operation pin 46a of the outer sheath 24a is moved to the position of the front end mark 54a, the position of the intermediate mark 54b, the base end with reference to the numbers “1”, “2”, and “3”. By retracting stepwise to the position of the mark 54c on the side, the stent graft 10 can be deployed stepwise, as in the case of the delivery device 20. That is, in the stent graft system 12a, the sheath 24 (outer sheath 24a) and the operation portion 40a constitute a deployment amount adjusting mechanism 49a.

  Therefore, by setting the operation pin 46a at the position of the mark 54a on the distal end side, the stent graft 10 is in the state shown in FIG. 5B, and subsequently, by setting the operation pin 46a at the position of the intermediate mark 54b, the stent graft 10 6B, and the stent graft 10 is brought into the state shown in FIG. 7B by setting the operation pin 46a at the position of the mark 54c on the proximal end side.

  As shown in FIGS. 12A and 12B, the stent graft system 12b includes a delivery device 20b having an operation portion 40b in place of the delivery device 20 (20a), in which the sheath 24 is configured by only one layer of the outer sheath 24a. .

  The operation unit 40b constituting the delivery device 20b includes a housing 60 in which the shaft 36 is housed and fixed, a long rod-like rack 62 housed in the housing 60 and connected to the proximal side surface of the outer sheath 24a, and the rack 62. An operation roller 64 having a pinion gear 64a meshing with the gear 62a on the side surface is provided, and a part of the operation roller 64 is exposed to the outside from an opening 60a formed in the housing 60.

  The pinion gear 64a has a smaller diameter than the operation roller 64 and is disposed on the rotation shaft 64b of the operation roller 64. By rotating the operation roller 64, the rack 62, that is, the outer sheath 24a is interposed via the pinion gear 64a. Can be driven forward and backward to stop at a desired position. A small window 66 is opened on the upper surface of the housing 60 along with the opening 60 a facing the operation roller 64, and the small window 66 is one of the marks 68 a to 68 d provided on the upper surface of the rack 62. The position and shape are set so that one can be confirmed. Each of the marks 68a to 68d is printed or engraved with numbers “0”, “1”, “2”, “3”, for example.

  In the delivery device 20b, the operation roller 64 is rotated to drive the rack 62 backward, and the outer sheath 24a is stepwise retracted to the position where the marks 68a to 68d are arranged in the small window 66, thereby delivering the delivery device 20, As in the case of 20a, the stent graft 10 can be deployed in stages. That is, in the stent graft system 12b, the sheath 24 (outer sheath 24a) and the operation portion 40b constitute a deployment amount adjustment mechanism (multistage adjustment mechanism) 49b.

  Therefore, in the delivery device 20b, the first mark 68a is disposed in the small window 66 in a state where the stent graft 10 is completely stored in the outer sheath 24a (see FIG. 2B), and the operator reads “0”. Can do. In this state, when the sheath 24 is advanced into the body and the stent graft 10 is deployed at a predetermined position, the operation roller 64 may be rotated to retract the rack 62. First, the stent graft 10 is brought into the state shown in FIG. 5B by rotating the operating roller 64 until the second mark 68b (“1”) is disposed in the small window 66. Subsequently, by rotating the operating roller 64 until the third mark 68c (“2”) is disposed in the small window 66, the stent graft 10 is in the state shown in FIG. 6B, and the fourth mark 68c ( By rotating the operating roller 64 until “3”) is disposed in the small window 66, the stent graft 10 is in the state shown in FIG. 7B.

  In the delivery devices 20a and 20b according to the modified example, it is not always necessary to remove the outer sheath 24a in three stages. For example, the stent graft 10 is substantially divided into two stages as in the case of the two-layer sheath described above. Marks 54a, 68a, etc. may be installed so as to unfold.

  Note that the present invention is not limited to the above-described embodiment, and it is needless to say that various configurations and processes can be employed without departing from the gist of the present invention.

  The above-described stent graft 10 and stent graft system 12 can also be used for applications other than the blockage of sympathetic nerves such as renal arteries, for example, procedures for expanding a stenosis occurring in a desired blood vessel wall such as the renal arteries.

  For example, when an excessive stenosis occurs in the renal artery, forcible expansion of the stenosis with a general balloon catheter or stent may cause blood vessel perforation. Therefore, by using the system 12 to place the stent graft 10 in the stenosis, treatment for expanding the stenosis can be performed. That is, in substantially the same manner as in the case of cutting the sympathetic nerve 18 described above, the stent graft 10 is disposed in a desired stenosis portion, and the stent graft 10 is deployed in the stenosis portion, whereby the stenosis portion is appropriately cut with the blade 22. The stent 28 can be easily expanded by the expansion force. At this time, since the stent graft 10 is placed around the cut stenosis, blood leakage is prevented. That is, by using the stent graft 10 for the treatment of a stenosis, the stenosis can be cut and expanded, and the blood vessel can be repaired after cutting.

10, 10a ... stent graft
12, 12a, 12b ... stent graft system 20, 20a, 20b ... delivery device 22 ... blade 24 ... sheath 24a ... outer sheath 24b ... intermediate sheath 24c ... inner sheath 26 ... graft 28 ... stent 30 ... cylindrical portion 31 ... hook 36 ... shaft 40, 40a, 40b ... operation parts 49, 49a, 49b ... deployment amount adjusting mechanism 52 ... needle

Claims (14)

  A stent graft characterized in that a piercing member capable of piercing a living tissue is provided on the outer surface of a cylindrical portion in which a metal skeleton is fixed to a tube-shaped graft. The stent graft of claim 1,
The stent graft, wherein the piercing member is a blade capable of cutting the living tissue or a needle capable of piercing the living tissue. The stent graft of claim 2,
The stent graft according to claim 1, wherein the piercing member is capable of piercing the living tissue in a direction toward a radially outward direction of the cylindrical portion. The stent graft of claim 3,
The stent graft according to claim 1, wherein the piercing member is changeable from a stored posture folded along an axial direction of the cylindrical portion to a piercing posture standing up in a radial direction of the cylindrical portion. In the stent graft according to any one of claims 1 to 4,
The stent graft according to claim 1, wherein a plurality of the piercing members are provided in a circumferential direction of the cylindrical portion. The stent graft of claim 5,
A plurality of pairs of the piercing members arranged at predetermined intervals in the circumferential direction of the cylindrical portion are provided in a plurality of rows along the axial direction of the cylindrical portion, and the phases of the piercing members of each set in the circumferential direction are provided. The stent graft is characterized in that is arranged shifted in each row. In the stent graft according to any one of claims 1 to 6,
The stent graft, wherein the piercing member is disposed at a position including an axial center of the cylindrical portion. The stent graft according to any one of claims 1 to 7,
The stent graft according to claim 1, wherein a locking tool for positioning and holding the stent graft in the body cavity is provided at a distal end and a proximal end of the cylindrical portion. In the stent graft according to any one of claims 1 to 8,
The stent graft, wherein the living tissue is a renal artery and a nerve around the renal artery. The stent graft of claim 9,
A stent graft, wherein the piercing member is coated with a drug that blocks transmission of the nerve or inhibits regeneration of the nerve. A stent graft provided with a piercing member capable of piercing a living tissue on the outer surface of a cylindrical portion in which a metal skeleton is fixed to a tubular graft;
A delivery device that has a sheath capable of accommodating the stent graft in a lumen, and a deployment amount adjusting mechanism capable of deploying the stent graft accommodated in the sheath in stages, and delivers the stent graft into a body cavity;
A stent graft system comprising: The stent graft system of claim 11.
The sheath is provided with at least two layers,
The delivery device includes the deployment amount adjusting mechanism capable of deploying the stent graft stepwise by retracting the sheath of each layer individually. The stent graft system of claim 12,
The piercing member is disposed at a position including the axial center of the cylindrical portion,
The sheath has an outer first sheath, an intermediate second sheath, and an inner third sheath;
The stent graft has a distal end side accommodated in the lumen of the first sheath, the blade is accommodated in the lumen of the second sheath, and a proximal end side is accommodated in the lumen of the third sheath. A featured stent graft system. The stent graft system of claim 11.
The delivery device includes the deployment amount adjusting mechanism capable of deploying the stent graft in stages by retracting the sheath at a predetermined distance in the axial direction.

Images