Stent implant having pleated implantation member

Description: TECHNICAL FIELD [Detailed description of the invention]

【0001】

[Technical field to which the invention belongs]

The present invention relates to a percutaneously supplied stent for repairing an aortic aneurysm.

【0002】

[Conventional technology]

An abdominal aortic aneurysm is a sac or sac caused by abnormal dilation of the arterial wall, which is the main artery of the body where the aorta passes through the abdomen. The abdomen is the part of the body that lies between the thorax and the pelvis. The abdomen has a hole known as the abdominal cavity, which is separated from the thoracic cavity by the diaphragm and the inside is covered by a membrane called the peritoneum. This artery is the main trunk or artery, from which the system of arteries extends throughout the body. This artery rises from the left ventricle of the heart, bends above the thorax, passes through the thorax, descends, extends through the abdomen to approximately the level of the 4th lumbar vertebra, and is the 4th lumbar vertebra. It is separated into two common iliac arteries in the vicinity of.

【0003】

Aneurysms often occur, for example, in the subrenal part of the diseased aorta below the kidney. If left untreated, the aneurysm will eventually rupture its sac with certainty of fatal bleeding in a very short period of time. The high mortality associated with this sac rupture has advanced the art and transabdominal surgical repair of abdominal aortic aneurysms to the present stage. However, surgery involving the abdominal wall is a major surgery with high risk. In addition, generally synthetic tubes, or implants, where the diseased or aneurysm portion of a blood vessel is usually made of DACRON®, TEFLON®, GORTEX® or other suitable material. There is considerable mortality and morbidity associated with the scale of surgical intervention, including replacement with a prosthesis device.

【0004】

In order to perform the above surgical procedures, it is necessary to expose the aorta through an incision in the abdomen that can reach the pubis from the thorax. In addition, the aorta can be clamped across the aneurysm above and below the aneurysm so that the aneurysm can be opened to remove embolus, blood clots, and debris from arteriosclerosis. is necessary. In addition, the bifurcation of the small artery exiting the dorsal wall of the aorta is tied up. A DACRON® tube or implant of approximately the same size as a normal aorta is then sutured to replace the aneurysm. Blood flow is then resumed through this implant. It is necessary to move the intestinal tract to the dorsal wall of the abdomen before clamping the aorta.

【0005】

If surgery is performed before the abdominal aortic aneurysm ruptures, the survival rate of treated patients is much higher than if surgery is performed after the aneurysm ruptures, but the mortality rate is still relatively high. high. Although this abdominal aortic aneurysm can be detected by routine examination, the patient may not feel any pain due to this condition. Therefore, if the patient does not undergo this routine examination, the aneurysm can progress to the rupture stage.

【0006】

The disadvantages associated with conventional conventional surgery described above, in addition to its high mortality rate, are the extended recovery period, implants or tubes associated with large surgically exposed areas in open surgery as described above. Difficulty when suturing to the aorta, loss of existing thrombotic sites to support and reinforce the implant, surgical inadequacy for many patients with abdominal aortic aneurysm, and urgently after the aneurysm ruptures There are various problems associated with performing surgery. For the recovery period, the patient can be expected to take a week or two in the hospital after the surgery, most of which is spent in the intensive care unit, especially when the patient has the heart, lungs, liver, and / Or if you have another illness, including a kidney illness, you will need an additional two to three months of recovery at home, in which case you will stay in the hospital longer. It is necessary to fix or suture the graft to the rest of the aorta, but the condition of the thrombus in the rest of the aorta often makes the suture difficult, leaving the rest of the aortic wall It is brittle and can easily crumble.

【0007】

Since the thrombus site is completely removed in conventional surgery, the new implant cannot utilize the existing thrombus site at that site. If the implant can be inserted into such an existing thrombus site, the site can be used to support and reinforce the implant. Many patients have aortic aneurysms along with other chronic illnesses, including heart, lung, liver, and / or kidney disease, so given the fact that many of these patients are aging, major surgery It is not an ideal candidate for possible current surgical procedures. That is, such patients have difficulty surviving after surgery. In addition, if the aneurysm ruptures, it becomes urgently difficult to perform conventional surgery depending on the degree of surgery.

【0008】

Therefore, the above prior art has taught various methods and devices for repairing an abdominal aortic aneurysm, which do not require abdominal incision and general anesthesia and can be sutured to the remaining aortic wall of the implant. It is believed to reduce its morbidity and mortality by not requiring it, and it also allows the existing aortic wall and thrombus sites within it to be maintained to reinforce and support the aortic implant. Examples of such methods and devices are U.S. Pat. Nos. 5,316,023 issued to Palmaz et al. On May 31, 1994, and U.S. Pat. Nos. 5,360,443, 1996 issued to Barone et al. On November 1, 1994. It is described in US Pat. No. 5,578,071 issued to Parodi on November 26, 1997, and US Pat. No. 5,591,229 issued to Parodi on January 7, 1997, respectively, all of which are described in their entirety. Included herein as a reference.

【0009】

The device as an example disclosed in the Barone patent above employs an improved method for repairing an abdominal aortic aneurysm in an aorta with two concomitant iliac arteries. The device comprises a first tube and a second tube, preferably these tubes are DACRON® and other polyester materials, TEFLON® (polytetrafluoroethylene), TEFLON®. It is made of a variety of materials including DACRON® coated with (trademark), porous polyurethane, silicone, foamed polytetrafluoroethylene, and foamed polyurethane. Preferably, all of the above materials are porous and capable of forming an endometrium on each tube. Each tube is connected to an expandable and deformable tubular member or stent. Such stents were issued in US Pat. No. 4,733,665 issued May 29, 1988, US Pat. No. 4,739,762 issued April 26, 1988, and October 11, 1988. It has a structure similar to each structure described in the disclosure of U.S. Pat. No. 4,776,337, all of which are Julio C.I. Palmaz is the inventor, each of which is included herein as a reference. Each of the above tube / stent structures is further located at the end of the balloon catheter. Both tubes are inserted into the same femoral artery, or one tube is inserted into one femoral artery of the patient and another tube is inserted into another femoral artery of the patient. Each tube is then fed through the lumen to the aorta, where at least a portion of each tube is placed within the abdominal aortic aneurysm. In addition, a balloon on the tip of each catheter expands to expand and deform the tubular member or stent, pushing these tubular members radially outward and into contact with the aorta and with each other. This allows each tubular member and at least a portion of each tube to be anchored within the aorta, allowing each tube to act as a bidirectional flow path within the abdominal aortic aneurysm.

【0010】

Although the above device seems to work well, there are still some areas where improvement in the device is desired. In particular, it is necessary to ensure that most of the blood flowing in the abdomen flows into the bidirectional flow path and does not flow around it, and the presence of a flow other than such a flow path causes further damage. growing. Each disclosure is included in the specification as a reference. European Patent Application No. 0947179 filed on March 29, 1999 and European Patent Publication filed on November 8, 1999, which are jointly transferred. The precursor stent gasket described in No. 1000590 and pending US Patent Application No. 09 / 404,660 filed September 24, 1999 leaked around the bidirectional flow path and aneurysm. Limit the amount of blood that can flow into it. This precursor stent gasket is placed in the lower neck of the kidney between the patient's abdominal aortic aneurysm and renal artery to assist in repairing the abdominal aortic aneurysm. The stent is configured to connect to a bidirectional implant to generate blood flow. This implant has a distal end for positioning the distal end of the aneurysm and a proximal end for positioning the proximal end of the aneurysm. This precursor stent gasket comprises a base end, a tip, and a substantially cylindrical expandable member with a constant interior. In addition, the stent gasket comprises a compressible gasket member that is located and attached to the interior of the expandable member. This compressible member is substantially impermeable to blood when in a compressed state and is attached to the implant. This causes the connected device to create blood flow in the implant while the gasket member substantially blocks the flow of blood into the aneurysm.

【0011】

[Problems to be Solved by the Invention]

Each of the above devices is a major improvement in the prior art, but further improvements are needed. That is, it is desired to have a more excellent device for attaching the transplant material to the graft used in each of the above devices. It is also desired to have an improved stent-gasket member for better attachment of the stent-gasket member to the aortic wall. It is also desired to have a mechanism to ensure that the stent-gasket member is not deployed prematurely. Furthermore, it is desired to improve the composition of the stent implant in order for the stent implant to work better. In addition, it is desired to improve the implant in the stent implant itself in order for the stent implant to work better during deployment. The present invention described below provides an apparatus with the above improvements.

【0012】

[Means for solving problems]

According to the present invention, a stent implant is provided for insertion into a blood vessel in the patient's body, which substantially has a body portion, two open ends and a longitudinal axis between them. It has a cylindrical, radially expandable hollow stent. The body of the stent is made up of multiple internally connected strut parts. The stent implant further comprises an implant member attached to the body portion of the stent, which implant member has a plurality of substantially longitudinally oriented pleats located on its surface. doing. In a particularly preferred embodiment, the implant further comprises a plurality of radially oriented pleated breaks located on its surface. The above and other aspects of the invention can best be understood by the detailed description of the invention based on the accompanying drawings below.

【0013】

BEST MODE FOR CARRYING OUT THE INVENTION

An example of a preferred method of use of the present invention is to treat an abdominal aortic aneurysm. The apparatus of the present invention and its usage in the treatment of abdominal aortic aneurysm can be further understood by reading the following description with reference to the above references included in the present specification. In addition, the terms cranial and apical mean the direction towards the patient's head, and the caudal or proximal side means the direction away from the patient's head.

【0014】

In a drawing showing components with the same reference number or reference numeral throughout each drawing, FIG. 1 is a diagram showing a precursor stent 10. As described below, the stent 10 is deployed in the inferior neck of the kidney between the patient's abdominal aortic aneurysm and renal artery to assist in repairing the abdominal aortic aneurysm. The stent is configured to connect to one or more stent grafts to create blood flow in the aneurysm. In addition, the stent comprises a substantially cylindrical self-expanding member 12 made up of a plurality of strut members. The member has two open ends, i.e., a base end 14, a tip 16, and a longitudinal axis extending between them, and an interior 18. In addition, the precursor stent has at least two, preferably eight spaced longitudinal foot 20s as shown in FIG. 1, each foot 20 having a proximal 24 and a tip, respectively. It has a part 26. Preferably, each foot 20 extends from each apex 11 in the diamond-shaped portion 13 (these diamond-shaped portions are formed by the strut portions). The tip 26 of each foot 20 is attached to the base 14 of the member 12, and these feet 20 extend so as to be separated from the member toward the base. At least one, preferably each foot 20, has a flange 28 near its proximal end, and the stent is placed in its feeder after partial or complete deployment of member 12, as detailed below. It can be recovered to allow rotation or repositioning for proper alignment.

【0015】

The self-expanding stents described herein are preferably made of a superelastic nickel-titanium alloy (Nitinol). Descriptions of medical devices using such alloys are described in US Pat. No. 4,665,906 issued to Jervis on May 19, 1987, and European Patent Application No. 4, filed on January 8, 1999. As can be found in 0928606, both of these references are included herein as references. Preferably, the stent 10 is laser-cut from a tubular member piece of nickel-titanium alloy and then treated to exhibit superelastic properties at body temperature. This stent 10 is shown in each drawing as a stent with a diamond-shaped pattern of approximately 8 diamond-shaped portions, and when the stent is fully expanded, these diamond-shaped portions will have their respective tips and proximal ends, respectively. The part has an angle of 45 to 55 degrees. However, the stent 10 can employ many different patterns or shapes.

【0016】

In an example of an embodiment of the precursor stent 10, the precursor stent 10 further comprises a gasket member 30, as shown in most drawings but removed from FIG. 1 for brevity. This forms a stent gasket or stent implant. This feature can be better understood by referring to Figures 2 and 3. As can be seen from these drawings, the precursor stent 10 further comprises a gasket member 30. The gasket member 30 surrounds the member 12 and can be arranged along the inside of the member 12, the outside of the member 12, or both. The gasket member 30 impedes blood flow around the stent implant and around the precursor stent itself after insertion of the stent implant (as shown in FIG. 19), as described below. Assist in that. In the case of this embodiment, the gasket member 30 is a compressible member arranged along both the inside and the outside of the expandable member 12.

【0017】

The gasket member 30 can be made of any number of materials known to those skilled in the art. The gasket member 30 is preferably made of open cell polyurethane foam, but for forming flexible structures such as polyethylene, polytetrafluoroethylene, and Dacron, polyurethane, polypropylene, polytetrafluoroethylene. Other flexible foaming materials can also be used, including a variety of other woven or knitted polymeric materials. Preferably, the polyurethane foam material described above has a pore size of 50 to 100 pores per inch (2.54 cm), and the density of the foam is 1 cubic foot (approximately 2.83 x 10).⁴1.5 to 3.5 pounds (0.68 to 1.59 kilograms) per cubic centimeter. Foaming materials of this quality absorb blood like a sponge and store blood that can form thrombus sites. In addition, this foam material forms a lattice structure for cell infiltration and acts as a support structure for tissue uptake. This allows the device to better anchor in the body and prevent the stent from moving. An example of such a foaming material is shown in the photograph of FIG. That is, FIG. 21 is a scanning electron micrograph of an open-cell polyurethane foam having pores of about 200 micrometers to 500 micrometers.

【0018】

The action of tissue being incorporated into the open cell foam structure from the arterial wall is described by the transferee as "Biofusion". The effect of this tissue uptake is best understood by referring to Photo 21 and Photo 22. FIG. 22 is a diagram showing a histological photograph of connective tissue infiltrated and fused into the gasket member 30 one month after the device implanted in the target blood vessel. The healing action of such tissue into the foam forms long-term stable biological inclusions that will not separate from the tissue until approximately 6 weeks after transplantation unless the foam material is torn. .. Such a "Biofusion" action has many advantages. First, there is an advantage that future internal leakage can be avoided by preventing misalignment or recommunication of the unorganized solidified region. Further, it is considered that the above-mentioned "Biofusion" forms a color structure of connective tissue around the gasket, and this color structure can prevent the aortic neck from expanding over time. Furthermore, by limiting the swelling of the neck in this way, it is possible to block the path of internal leakage caused by inadequate fitting to the aorta and prevent the movement of the implant. The use of foam material on a stent implant as described above is not limited to the repair of abdominal aortic aneurysms, but can be applied to many other stent implant applications including aneurysm repair and vascular malformations and occlusions. ..

【0019】

It is preferred that the foam material is highly compressible and can be kept compact enough for good supply. In addition, it is preferred that the gasket member is substantially impermeable to blood flow, at least in a partially compressed state. When used in the present invention, the material that does not substantially permeate the blood flow as described above includes a material that does not substantially permeate the blood flow after being saturated with blood. The gasket 30 is compressed when a stent tube and a transplant member, as described below, are inserted into and expanded into the gasket 30. In this state, the gasket 30 is impermeable to blood and needs to prevent blood from flowing into the aneurysm via the interior 18 of the member 12. Gasket 30 is the expandable member by any number of means including polyurethane adhesives, polypropylene, multiple conventional sutures such as DACRON®, or any other suitable material and materials attached thereto. Can be attached to 12. Further, alternative methods for attaching the gasket 30 to the expandable member 12 include adhesives, ultrasonic welding, mechanical tightening, staples and the like.

【0020】

As can be seen from FIG. 2, preferably, the stent 10 has a large number of radiopaque markers 15. As shown, these markers 15 are radiation impermeable metal coils that wrap each strut portion of the stent. Each marker is placed along the stent, allowing the physician to know the exact location of the stent being deployed relatively well in a fluoroscopic observation. Preferably, each marker 15 is made of 0.010 inch (0.025 cm) diameter tantalum (Ta) wire tightly wrapped around each strut portion. Three markers are used, two are located near the tip of the device and one is located closer to the proximal end than these. The two on the tip side are separated at an angle of 180 degrees, and the one on the base end side is placed at equal intervals between the two on the tip side when viewed in the rotational state where the top two are the most distant. Has been done. This proximal marker assists in positioning the proper rotation of the device. In particular, one of the distal markers is 5 mm long and is located near the hole 34 of the gasket, and the other marker is 2 mm long and is located near the hole 36. Since this hole 36 needs to be placed close to the right side of the aneurysm, as shown in FIG. 19, the smaller distal marker above needs to be placed on the right side, and the proximal marker (the proximal marker ( It should also be visible in fluorescence perspective between the two markers above) (which is also 2 mm long).

【0021】

As can be seen from FIGS. 2 and 3, the precursor stent further comprises an occlusion member 32 attached to the member 12. The closing member 32 covers at least a part of the inside of the expandable member 12. The closing member 32 covers the inside of the member 12 so as to at least partially block the inner hole 5 of the expandable member 12 forming a passage from the base end 14 to the tip end 16. It has become. Further, the closing member 32 has two openings 34 and an opening 36 penetrating the closing member 32. Opening 34 is relatively small and is configured to receive a guidewire Te fence, the guide wire helps to provide a stent 10 to the target site. The guidewire 36, on the other hand, is configured to receive another guidewire that is relatively large and has a stent implant loaded on its proximal side. As described below, the obstruction member 32 assists in ensuring proper side-by-side placement of the two stent implants.

【0022】

The precursor stent 10 acts to temporarily support the gasket member in the body until the stent implant is deployed (see FIG. 19). FIG. 4 shows a preferred embodiment of the stent 40 for use in a stent implant according to the invention. The stent 40 is made up of a plurality of internally connected strut portions 44 and has an inner surface portion 41 and an outer surface portion 43 (shown in FIG. 15). Figure 4 shows a fully dilated, non-constricted stent 40. As understood by experts in the art, the stent 40 needs to be amplified to a smaller diameter before being inserted into the patient's body. Preferably, the stent 40 is made of superelastic Nitinol, which can generate a sufficiently large outward force to stay in the body without the use of precursor 10. Preferably, the stent 40 is made from a single tube of nitinol and has the following shaped portions formed by laser cutting inside. That is, the stent 40 has a large number of hoops 42 composed of a large number of strut portions 44 forming a diamond-shaped portion, and each hoop 42 has 9 diamond-shaped portions. It is preferable to have. In addition, the stent 40 includes a number of sinusoidal rings 50 for connecting each adjacent hoop to each other. These sinusoidal rings 50 are made up of a large number of alternatingly oriented strut portions 52, preferably each ring 50 having 54 strut portions 52. As detailed below in connection with the description of FIGS. 9-14, the stent 40 includes a distal attachment means 54 and a proximal attachment means 56.

【0023】

The stent 40 has a proximal hoop 48 and an distal hoop 46, which are also called anchors. The proximal hoop 48 is flared and is the exposed portion of the implant after it is attached. The diamond pattern on these anchors and other hoops imparts constant stiffness along the radial and longitudinal directions to each hoop. This longitudinal strength allows the stent 40 to be better mechanically secured to the implant (discussed below). On the other hand, the radial strength allows the distal hoop 46 to be better attached and sealed to the stent gasket 10 and the proximal hoop 48 to be better fixed and sealed to the arterial wall. .. In one example of a preferred embodiment, these proximal and distal hoops have greater radial and longitudinal strength than the hoops in between. This allows the formation of a stent implant with a relatively rigid end for fixation and a relatively flexible body for maneuvering within the vessel. Such a relatively rigid end can be realized by changing the dimensions of the strut portion of each end hoop, or by changing the heat treatment of each end hoop during manufacturing. Each ring portion allows the stent to flex easily and generally acts to increase flexibility as the stent is fed into the winding vessel. When an inflexible implant is attached to the stent 40, the strength of each diamond hoop supports the fold of any implant in its blood flow cavity while maintaining a constant twist radius of the implant. ..

【0024】

As mentioned above, the stent 40 preferably has an implant member attached to it. The implant covers at least a portion of the inside or outside of the stent 40, most preferably substantially all of the outside of the stent 40. 5 to 7 show embodiments of the tubular implant 60 for use in the present invention. The transplant member 60 can be made of any number of materials known to those skilled in the art, including polyester woven fabrics, Dacron, Teflon®, or polyurethane. The implant 60 has a proximal end 64, an distal end 62, and a longitudinal axis 66 extending between them. As can be seen from FIG. 5, the implant 60 has a plurality of longitudinal pleats 68 extending along its surface and approximately parallel to the longitudinal axis 66. In addition, as can be seen from FIG. 7, when the implant 60 collapses around its center, as is the case when it is fed into the patient's body, the pleats 68 in the implant 60 are efficiently oriented along a series of radial directions. Combined as a well-tied, regular fold, minimizing its wrinkles and other external irregularities. Upon subsequent expansion, the implant 60 will have its natural cylindrical shape and the pleats or folds will spread uniformly and symmetrically.

【0025】

Each pleats 68 forms a relatively uniform atrophy state in the implant 60, which provides a relatively small supply of the assembled stent implant (the stent 40 attached to the implant 60 as described below). It can be inserted into the system in a contracted state, and controlled and steady deployment from the system can be performed. In addition, the pleats 68 facilitate the manufacture of stent implants in that they point in a direction parallel to the longitudinal axis, allowing the stent to be attached to the implant along these lines and after attachment. Prevents the piece from accidentally twisting against the stent. Further, since only the pleated end of the implant is in contact with the inner surface of the feed system, the force required to push the stent-graft assembly out of the feed system can be reduced. In addition, another advantage of the pleats is that blood tends to coagulate approximately non-uniformly in the grooves of each pleat, thus suppressing the formation of asymmetric and large coagulum on the surface of the implant, reducing the possibility of embolization. You can do it.

【0026】

In an example of a preferred embodiment, a implant having an inner diameter of 0.08 inches (0.20 centimeters) and an outer diameter of 0.131 inches (0.333 centimeters) to 0.155 inches (0.394 centimeters). In contrast, the depth of each pleated 68 ranges from 0.06 inches (0.15 centimeters) to 0.07 inches (0.18 centimeters). Such a combination of the pleated depth and the inner and outer diameters of the implant can form a pleated waveform that largely eliminates the radial spread of the implant beyond the diameter range corresponding to the device.

【0027】

As best seen in FIG. 6, the implant 60 has a pleated break 70 that is radially oriented. These pleated breaks 70 are substantially circular and oriented perpendicular to the longitudinal axis 66. The pleats 68 above form a uniform atrophy of the graft 60 and extend perpendicular to the natural folding direction of the graft as it bends along its axis. Tends to increase its twistability. On the other hand, the pleated interruption portion 70 allows the implant to flex relatively well at a given point. Such a configuration can provide a graft with good contractility and improved twist resistance.

【0028】

FIG. 9 is an enlarged view of the distal end side attachment means 54 of the stent 40. The distal hoop 46 of the stent 40 has a plurality of mounting tabs 82 that extend from now on, and these tabs 82 are integrally joined by two strut portions 44 (a) and strut portion 44 (b). It is formed by. The mounting means 54 has two holes 84 (first hole) and holes 86 (second hole) that penetrate the mounting means 54. As can be seen in FIG. 10, the implant 60 preferably has two additional holes 74 and 76, which are initially formed during the mounting process, and these holes are the implant 60. Overlaps holes 84 and 86, respectively, when placed on the stent 40 to attach. In addition, the stent implant 80 comprises a crown 92 and a staple 90 having a mounting foot 94 (first foot) and a mounting foot 96 (second foot) extending from it. The mounting foot 96 is inserted into the hole 76 and then into the hole 86. At the same time, the foot 94 bends around the notch 85, but does not penetrate the implant 60 like the foot 96. The mounting foot 94 and the mounting foot 96 then bend into the holes 84 and 74 toward the crown 92, and the tip of the implant is attached to the tip of the stent as shown in FIG. Each foot 94 and 96 contacts the crown 92 after this attachment. Preferably, six staples are present at the tip.

【0029】

FIG. 12 is an enlarged view of the proximal end side mounting means 56 of the stent 40. The proximal hoop 48 of the stent 40 has a plurality of members 110 formed by the coupling of four strut portions 44 (c) to 44 (f). The mounting means 56 has three holes 112 (first hole), 114 (intermediate hole) and 116 (second hole) that penetrate it. As can be seen in FIG. 13, the implant 60 preferably further comprises three holes 121, 123 and 125, which can be initially created during the staple mounting process, which are the implants. It overlaps the holes 112, 114 and 116 above, respectively, when placed on the stent 40 to attach the piece 60. In addition, the stent implant 80 comprises a crown 122 and a staple 120 with an extending foot 124 (first foot) and 126 (second foot). The feet 124 and 126 pass through the holes 121 and 125 before being inserted into the holes 112 and 116. Each foot 124 and 126 then bends into the holes 114 and 124 towards the crown 122 and the graft proximal end is attached to the stent proximal end as shown in FIG. The feet 124 and 126 make contact with the crown 122 after this attachment. Preferably, three staples are present at this base end.

【0030】

The staple-hole configuration has many advantages when attaching a stent to a graft. That is, since each foot of the staple is bent and folded into the pocket-shaped portion, the risk of drilling an inflated balloon can be minimized. In addition, the stent allows the implant to be more firmly anchored to the stent as compared to prior art configurations that use sutures or adhesives to attach the implant to the stent. -It is believed that the structural integrity of the graft assembly will be enhanced. Each staple 90 and 120 can be made of any number of materials known in the art, including tantalum alloy, platinum alloy or stainless steel such as 316LVM stainless steel. In addition, these staples can take different forms and shapes and can be coated for lubricity imparting and the like. Staples made from radiation-impermeable materials can also help physicians deploy the device correctly.

【0031】

Another feature of stent graft 80 can be better understood by referring to its feeder 130 shown in FIG. This device 130 is very similar to another self-expanding feeder described in the references contained herein above. The device 130 comprises an outer sheath 132, which is a substantially elongated tubular member similar to a conventional guiding catheter known to the ordinary expert in the art. An example of a particularly preferred outer sheath is described in US Pat. No. 6,019,778, issued and co-assigned February 1, 2000, which is included herein as a reference. The sheath 132 has a tip 134 and a proximal end (not shown). The device 130 further comprises an inner shaft 140 that is coaxially arranged within the outer sheath 132 prior to deployment. This inner shaft portion has a tip portion 142 and a base end portion (not shown). The tip 142 of the shaft 140 has at least two grooves 144 arranged above it. Preferably, the stent 40 has a large number of flanges 41 located at its proximal end. The flange 41 on these stents is placed in the groove 144 of the medial shaft to releasably attach the stent 40 to the medial shaft 140. The supply system for the precursor stent 10 also has an outer sheath and an inner shaft, which shaft has a groove for receiving the flange 28 of the precursor stent 10.

【0032】

The advantages of the flange 41 on the stent 40 and the flange 28 on the precursor stent 10 and the grooves on the inner shaft in their supply system are that they allow partial deployment of each stent and the doctor If the position of the stent is not satisfactory, it can be recaptured in its feeder. That is, the present invention allows a physician to partially deploy one of the stents (10 or 80) with the flange portion left in the sheath. This flange-groove combination allows the physician to "pull" the stent back into the feeder if the stent is not optimally positioned.

【0033】

The advantages of the flange 28 on the stent 10 and the groove on the inner shaft of its supply system can be best explained by reference to FIGS. 23-25. FIG. 23 is a diagram showing a feeder 300 for the stent gasket 10. This device 300 is very similar to another self-expanding feeder described in the references contained herein above. The device 300 comprises an outer sheath 332, which is a substantially elongated tubular member similar to a conventional guiding catheter known to the ordinary expert in the art. An example of a particularly preferred outer sheath is described in US Pat. No. 6,019,778, issued and co-assigned February 1, 2000, which is included herein as a reference. The device 300 further comprises an inner shaft portion 340 that is coaxially arranged within the outer sheath 332 prior to deployment. The inner shaft portion 340 has a large number of groove portions 344. As can be seen from FIG. 24, the above configuration allows partial deployment of the stent 10 and allows it to be recaptured within its feeder if the physician is not satisfied with the initial position of the stent. .. That is, the present invention allows a physician to partially deploy the stent 10 with the flange portion left in the sheath. This flange-groove combination allows the physician to "pull" the stent back into the feeder if the stent is not optimally positioned.

【0034】

It is preferred that a releasable stop member 350 be placed on the medial shaft to prevent the physician from prematurely deploying the stent 10 completely. The stopping member 350 can be a ring having a diameter larger than that of the sheath portion, and when the sheath is pulled toward the proximal end along the inner shaft portion, it abuts on the stopping member 350 to completely deploy the entire stent 10. Can be blocked. Preferably, the stop member 350 is releasably attached to the inner member and disengages from its inner shaft so that the outer member is fully slid back and the entire stent 10 is completely inside the body. It can be deployed.

【0035】

16 to 18 are diagrams schematically showing a method of deploying the device of the present invention in the body. Prior to reaching the condition shown in FIG. 16, the doctor first inserts the precursor stent 10 with the gasket member into the body with the assistance of the guide wire 200, which remains in the body after deployment. The stent gasket is supplied into the first iliac artery 1 via one of the patient's femoral arteries and is deployed in the inferior renal neck 3. The feeder for the precursor stent is then removed without removing the guidewire 200 and another guidewire 202 is inserted into another iliac artery 2 via another femoral artery. Due to the relatively large size of the opening 36 in the obstruction member 32, the doctor can steer the guide wire 202 only through it. Then, the stent-graft device 132 (a) and the stent-graft device 132 (b) are inserted into the femoral artery 1 and the femoral artery 2 while sliding on the guide wire 200 and the guide wire 202. Accurately supply to the site. Both stent grafts 80 (a) and graft 80 (b) are then deployed separately or simultaneously in the body. In addition, the height of each tip of the stent implant is aligned with each other just below the renal artery and at a constant height from the tip of the stent gasket. The body of each stent graft is then passed through the stent gasket and aneurysm sac.

【0036】

After proper supply, the precursor stent 10 and graft 80 (a) and graft 80 (b) should be placed as shown in FIG. The precursor stent 10 and the gasket member 30 attached thereto are fixed in the lower neck part 300 of the kidney. In this case, the outward force of the stent implant 80 on the precursor stent 10 assists in immobilizing the device in the body. In addition, each proximal end of this stent-graft assembly is anchored to iliac artery 1 and iliac artery 2. Blood then flows from the abdominal aorta 302 through the stent grafts 80 (a) and 80 (b) into the iliac artery 1 and the iliac artery 2 to bypass the aneurysm sac 304. be able to. If all these components are correctly placed, the tip of the device will be as shown in FIG.

【0037】

It is preferable to place a releasable stop member on the medial shaft to prevent the physician from prematurely and fully deploying the stent 10. The stopping member can be a ring having a diameter larger than that of the outer member, and when the outer member is pulled toward the proximal end along the inner shaft, it abuts against the stopping member and complete deployment of the entire stent 10. Can be blocked. This stop member is preferably attached to the inner shaft portion so as to be releasable by screw or snap fitting, and by disengaging the inner shaft portion, the outer member is sufficiently slid back and retracted to form a stent. The entire 10 can be completely deployed in the body.

【0038】

Although the specific embodiment of the present invention has been described above, it is possible to make changes to the above-mentioned apparatus and / or method without departing from the scope and purpose of the present invention. Each term used to describe the present invention is intended to explain the present invention, not to limit the present invention.

【0039】

Embodiments of the present invention are as follows. (1) The stent implant piece according to claim 1, wherein the implant member is attached to an outer surface portion of the stent. (2) The stent implant according to claim 1, wherein the implant member is attached to the stent by staples. (3) The stent implant according to claim 1, wherein the implant member is selected from the group of materials consisting of Dacron, Teflon®, polyester woven fabric, and polyurethane. (4) The stent implant according to claim 1, wherein the stent is a self-expandable stent. (5) The stent implant according to embodiment (4), wherein the stent is made of a nickel-titanium superelastic alloy.

【0040】

(6) The stent implant piece according to claim 2, wherein the implant member is attached to the outer surface portion of the stent. (7) The stent implant according to claim 2, wherein the implant member is attached to the stent by staples. (8) The stent implant according to claim 2, wherein the implant member is selected from the group of materials consisting of Dacron, Teflon®, polyester woven fabric, and polyurethane. (9) The stent implant according to claim 2, wherein the stent is a self-expandable stent. (10) The stent implant according to embodiment (9), wherein the stent is made of a nickel-titanium superelastic alloy. (11) The stent implant according to claim 2, wherein the pleated interrupted portion is composed of radial pleats.

【0041】

[Effect of the invention]

Therefore, according to the present invention, it is possible to provide an even better device for attaching the implant material to the implant used in the supply device for the self-expandable stent. Also, an improved stent-gasket member can be provided for better attachment of the stent-gasket member to the aortic wall. Also, a mechanism can be provided to ensure that the stent-gasket member is not deployed prematurely. In addition, the configuration of the stent implant can be improved in order for the stent implant to work better. In addition, the implant in the stent implant itself can be improved in order for the stent implant to work better during deployment.

[Simple explanation of drawings]

[Figure 1]

It is a perspective view of the precursor stent (shown in an expanded state without a gasket) made according to the present invention.

[Figure 2]

It is the same drawing as FIG. 1 including the gasket member produced according to this invention.

[Fig. 3]

It is sectional drawing of the precursor stent of FIG. 2 along line 3-3 in FIG.

[Fig. 4]

It is a side view of the internal graft stent shown in the expanded state before the transplant material supply.

[Fig. 5]

FIG. 4 is a side view of a graft pleated along the longitudinal direction for use with the stent of FIG. 4, and these pleats are discontinuous.

[Fig. 6]

It is a partial side view of another embodiment of the implant, in which longitudinal pleats are interrupted by pleats along the perimeter.

[Fig. 7]

It is an end view of the graft along line 7-7 of FIG. 5, and the broken line shows the graft change in the compressed state.

[Fig. 8]

It is a side view of a complete stent-graft assembly shown in the deployed (or expanded) state.

[Fig. 9]

FIG. 4 is a partially enlarged plan view of a mounting tab at the upper (cranial) end of the stent, shown in the circled area in FIG.

[Fig. 10]

A partially exploded cross-section of the mounting tab along line 10-10 of FIG. 9 showing a portion of the staple and implant material prior to anchoring the implant to the stent.

[Fig. 11]

It is a partial cross-sectional view of the attachment means after shrinking a staple.

[Fig. 12]

FIG. 4 is a partially enlarged plan view of the mounting node at the caudal end of the stent, shown in the circled area in FIG.

[Fig. 13]

A partially exploded cross-section of the mounting node along line 13-13 of FIG. 12 showing a portion of the staple and implant material prior to anchoring the implant to the stent.

[Fig. 14]

It is a partial cross-sectional view of the attachment means after shrinking a staple.

[Fig. 15]

FIG. 3 is a partially exploded perspective view of the upper end of a stent gasket or internal implant and a portion of the supply system in its post-release state from the end.

[Fig. 16]

FIG. 6 is a continuous schematic perspective showing how to position and deploy a stent implant or internal implant after the precursor stent has already been deployed.

[Fig. 17]

FIG. 6 is a continuous schematic perspective showing how to position and deploy a stent implant or internal implant after the precursor stent has already been deployed.

[Fig. 18]

FIG. 6 is a continuous schematic perspective showing how to position and deploy a stent implant or internal implant after the precursor stent has already been deployed.

[Fig. 19]

FIG. 5 is a side view of a fully deployed abdominal aortic repair system created in accordance with the present invention.

[Fig. 20]

It is a top view of the precursor stent when viewed along line 20-20 of FIG.

[Fig. 21]

FIG. 3 is a photomicrograph of the gasket material before substantial cell internal growth occurred, taken along lines 21-21 of FIG.

[Fig. 22]

FIG. 6 is a photomicrograph of the gasket material after substantial cell internal growth or biofusion occurs along line 22-22 of FIG.

[Fig. 23]

FIG. 6 is a schematic representation of a feeding system for a stent gasket made according to the present invention, which is inserted into an abdominal aortic aneurysm.

[Fig. 24]

The drawing is similar to FIG. 23, but shows the stent gasket partially deployed by its supply system.

[Fig. 25]

Similar to FIG. 24, but showing the stent gasket fully deployed by its supply system.

[Explanation of symbols]

10 Precursor stent 12 Self-expanding member 14 base end 16 Tip 18 inside 20 feet 30 Gasket member 40 stent 50 ring 60 Transplant material 70 pleated breaks 80 stent graft 90 staples 350 safety stop member