JP2008526381A - Apparatus and method for deploying a device embeddable in the body - Google Patents

Abstract

The implantable device (2) includes at least one main lumen (4) having a proximal end and a distal end, but often at least one side branch toward the implantation site having crossed blood vessels. Also includes lumens (6a, 6b, 6c). The delivery and deployment system includes at least one catheter (38) for selectively deploying the implant (2) as well as selectively placing the lumen of the implant (2) within the target vessel. Including. A plurality of filaments or threads are used to assist in the selective placement and deployment of the implant (2).
[Selection] Figure 1A

Description

CROSS-REFERENCE This application claims the registration January 4, 2006, the benefit of US Provisional Patent Application No. 60 / XXXXX. This application also claims the benefit of US Provisional Application No. 60 / 752,128, filed December 29, 2005. This application is a continuation-in-part of US Patent Application No. 11 / 033,479, registered on January 10, 2005, and is a part of US Patent Application No. 11 / 241,242, registered on September 30, 2005. This is a continuous continuation application. It is noted that this application is controlled to be consistent with any of the prior applications and claims priority under 35 U.S.C. 120. The entire patent application is hereby incorporated by reference.

  The present invention relates to the treatment of vascular diseases including, for example, aneurysms, vascular ruptures, pseudoaneurysms, removal, elimination of hypersensitive plaques, and treatment of occlusive conditions. More particularly, the present invention relates to an apparatus and method for transporting and deploying devices that can be implanted in the body to treat such conditions. The present invention is particularly suitable for implanting stents, grafts, and stent-grafts in arteries or other blood vessels at sites that include two or more intersecting blood vessels.

  Treating vascular disease with implantable stents and grafts is well known in the prior art. For example, it is well known in the prior art to interpose a self-expandable or balloon expandable stent in a stenotic or occluded portion of an artery. Similarly, grafts or stent grafts are used to repair highly damaged or sensitive parts of blood vessels, especially arteries, thereby ensuring blood flow and reducing the risk of aneurysm or rupture This is also well known in the prior art.

  If it is preferable to use a stent, graft, or stent-graft at or around the intersection of large arteries (eg, abdominal aorta) and one or more cross-artery sites (eg, renal artery) A tough situation appears. The use of a single axis stent or graft may effectively seal or close blood flow to an organ receiving a side branch supply, such as the kidney. U.S. Pat. No. 6,030,414 addresses this situation and includes a stent-graft having a lateral opening extending from a primary vessel in which the stent-graft is placed and having an axis coinciding with a plurality of side branch blood channels. Disclose the use of. This lateral opening is pre-positioned in the stent based on the identification of the relative position of the opening with the side branch vessel to be axially aligned. US Pat. No. 6,099,548 discloses a multi-branch graft and a system for deploying it. Implant implantation is extremely complicated, requiring separate balloon deployable stents for each to secure each side branch of the implant within a designated arterial branch. Furthermore, the system is relatively unsuitable for implantation into small vessels, as multiple stylets are required to transport the graft and occupy space in the vessel. In addition, graft and stent transport requires access and exposure by secondary arteriotomy for each vessel in which the graft is placed. Although effective, these techniques are laborious and, in some cases, difficult to adopt and implement. This is especially true when the implantation site includes two or more blood vessels that intersect the primary blood vessel, all of which require transplantation.

  The use of bifurcated stents to treat abdominal aortic aneurysms (AAA) is well known in the prior art. These stents have been developed specifically to address problems that arise when treating vascular injury or disease at or near the bifurcation. A bifurcated stent typically takes the form of a “pants” design. That is, it includes a tubular body or trunk and two tubular legs. Examples of bifurcated stents are presented in US Pat. Nos. 5,723,004 and 5,755,735. A bifurcated stent may take either the unit form or a modular form in which the components of the stent are interconnected within the body. In particular, one or both of the leg extensions can be attached to the tubular body. The transport of this modular system is mitigated by the relatively small components, but with the legs aligned to the main lumen with sufficient accuracy to completely avoid leakage. Difficult to do. On the other hand, although unit-type stents have a reduced probability of leakage, they are relatively large and often difficult to transport to a limited size treatment site.

  Although the use of conventional bifurcated stents has been somewhat successful in AAA treatment, it is not applicable when the implantation site is within the arterial arch. Since the arcuate region of the aorta is exposed to extremely high blood flow and blood pressure, it is difficult to place a stent-graft without stopping the heart and therefore leaving the patient to the cardiopulmonary device. In addition, for example, even when the stent-graft can be properly installed, it is exposed to long-term exposure to prevent the stent-graft from moving or leaking, The stent-graft must be secured in a manner that can withstand high blood flow, pressure, and shear forces. In addition, the aorta undergoes a relatively significant change in diameter (about 7%) due to vasodilation and vasoconstriction. In that case, if the aortic arch graft cannot expand and contract to accept such changes, the seal between the graft and the aortic wall will be inadequate and the graft will move and / or leak You will be exposed to the dangers of Furthermore, the complexity of anatomy of the aortic arch (eg, highly curvilinear form) and the variability that varies from person to person makes the aortic arch a difficult place to place a stent-graft. The number of vascular branches emanating from the arch is most commonly three, ie, the left subclavian artery, the left common carotid artery, and the anonymous artery, but in some patients, the number of vascular branches is One, more commonly two, in some cases four, five, or in some cases six. Furthermore, the spacing and angular orientation between vascular branches varies from person to person.

  In order to achieve axial alignment of the side branch stent or side opening of the main stent and the vascular branch, it is considered that a custom stent designed and manufactured according to the dimensional condition specific to each patient is required. Measurements required to build a custom-made stent that fits the patient's unique vascular anatomy can be obtained using spiral tomography, X-ray tomography (CT), fluoroscopy, or other vascular imaging systems. It would be possible to obtain. However, such measurements and the associated manufacture of such custom stents, although feasible, are thought to be time consuming and expensive. Furthermore, the creation of such custom stents is not feasible for patients who require immediate intervention, including the use of stents. In such situations, it would be highly desirable to have a stent that could be adjusted in situ during implantation. Similarly, it would be highly desirable if a sufficient number of adjustments were obtained that would allow a certain number of stents to be pre-manufactured and readily prepared to accommodate the size and shape requirements encountered. it is conceivable that.

  Another disadvantage of conventional stents and stent-grafts is that once the stent or stent-graft has been deployed, there is a limit to its position adjustment and subsequent retrieval. Often during the deployment of the stent, the final position of the delivery stent is determined to be not optimal to achieve the desired therapeutic effect. When deploying a self-expanding stent, the deployment method either pushes the stent out of the delivery catheter or, more generally, retracts the outer sheath while holding the stent in a fixed position relative to the vessel. It is. In either case, the distal end of the stent does not attach to the catheter and can be freely expanded to its maximum diameter, sealing the surrounding arterial wall. While this self-expanding capability is advantageous for deploying a stent, it is inconvenient for the user when it is desired to remove or re-install the stent. One design utilizes trigger wire (s) to selectively hold down the distal end of the stent until full deployment is desired, where full deployment is a “trigger” wire or tether wire (s). It is realized by canceling. The limitation of this design is that the diameter of the entire stent cannot be reduced by pulling on the stent because it is recessed toward the distal end by the trigger wire. It is important to reduce the diameter of the stent during installation and while deciding if it should be released from the tether wire. Otherwise, although the stent body is fully expanded, the blood flow will be closed by the stent body because the distal end is prevented from opening by the tether wire.

  Another disadvantage of conventional stent grafts is the primary blockage of blood flow through the blood vessels. In the case of balloon deployable stents and stent grafts, expansion of the balloon itself upon deployment of the stent or stent graft causes blockage of blood flow through the blood vessel. Further, in certain operations, another balloon is used at a site distal to the distal end of the stent delivery catheter to actively block blood flow during stent placement. In the case of self-expanding stent-grafts, a stent-graft misplacement can be caused by blockage of the arterial flow during deployment, which duplicates another stent-graft to complete vascular repair. It is necessary to install in. Even if the blood flow is not blocked, because of the moment of strong arterial blood flow, the blood that enters the partially deployed stent graft is partially opened by the pulsatile blood pressure impact force. May be pushed downstream.

  Several attempts have been made to address some of the aforementioned shortcomings of conventional stents and stent-grafts. For example, US Pat. No. 6,099,548 discloses the use of a thread that passes through the distal end of a stent inserted through the first opening of a blood vessel and is attached to the distal end. Next, the end of the thread is passed through the second opening of the blood vessel, allowing the stent to be moved inside the blood vessel when the end of the thread is pulled. The use of attached yarns provides new and slight control over the placement of the stent, but it would be difficult for those skilled in the art to thread the second opening inside the vessel. Is understood. Furthermore, minimizing the number of surgical openings is advantageous for patient comfort when performing any procedure.

  Current stent-grafts and stent-graft placement techniques are limited, and therefore, for implanting stents or grafts and for cross-vessels (ie, blood vessel branches) towards the shortcomings of the prior art There is clearly a need for improved means and methods for treating the affected vascular diseases and conditions.

SUMMARY OF THE INVENTION The present invention provides implantable devices and systems and methods for deploying the implantable devices in the body. Implantable devices include at least one main lumen having a proximal end and a distal end, but often include at least one side branch to accommodate an implantation site having crossed blood vessels. Devices, particularly devices in the form of stents, grafts, and stent-grafts, are composed of interconnected cells that are selectively manipulated to adjust the length and diameter of the main and side branch lumens of the device. The Thus, features of the present invention can accommodate tortuous vascular anatomy inconsistencies or variability that varies from patient to patient, e.g., accepting variability in the spacing or angular orientation of the vascular branches of the aortic arch Providing a sexable or adjustable stent, graft, or stent-graft.

  In one embodiment, an implantable adjustable stent is provided having a main lumen having a proximal end and a distal end and at least one side branch lumen extending therefrom. The side branch lumen can be adjusted laterally with respect to the proximal and distal ends along the length of the main lumen, and can also be adjusted with respect to the angle at which the side branch lumen intersects the main lumen. The stent has a first or non-reduced size “X” and a reduced size “Y” having any size between less than one half and less than one tenth of the first size “X”. Constructed from a superelastic wire material having. For aortic applications where the size is the diameter of the stent, the reduced diameter would be closer to one tenth of the unreduced diameter. The smaller the vessel in which the stent is implanted, the smaller the required diameter reduction.

  The system of the present invention allows the subject stent, graft, or stent-graft device to be placed in a blood vessel or tubular structure in the body, particularly when the implantation site includes two or more intersecting blood vessels. It is particularly suitable for transporting and deploying. In general, the transport and deployment system of the present invention has at least one elongate member or thread releasably attached to both lumen ends of an implantable device, and in many embodiments a plurality of elongate members or threads. Is used. Each of the proximal and distal ends of the main lumen of the device is provided with one thread or a set of threads, and each side branch lumen is provided with an additional thread or set of threads. . The system includes means for selectively tensioning each of the one or more accessory threads. Thus, the device is selectively deployed by releasing the tension on the attached thread. The delivery system adjusts the spacing between the various lumens and the radial angle direction of each of those lumens with respect to the main lumen, and thus changes the spacing and angular orientation within the body upon placement of the implant at the target location. It is possible. Besides the use of a releasable thread, there may be other means that are equally suitable for selective deployment of the stent. For example, similar to the use of a releasable coil used for aneurysm repair, current may be used to erode the connection points at both ends of the stent by electrolysis. In other words, the implantable device may be partially deployable. In so doing, the entire device may be exposed or partially exposed from the delivery system, most commonly in the form of a collection of overlapping catheters and lumens. Each luminal end of the implantable device may be individually deployed as needed. At that time, some or all of the luminal ends may be deployed at the same time, or they may be deployed in order to facilitate the embedding process.

  The implant delivery and deployment system in one embodiment includes a series of guidewires, a catheter distal portion, and a proximal handle portion, wherein the implantable device is in the catheter portion prior to delivery to the target site. Be loaded. At least the catheter portion of the system is advanced over one or more guidewires that direct and place the stent or stent-graft and each side branch into the respective target vessel selected for implantation. Various controls are provided to selectively apply and release the luminal end of the implant. In this case, the control unit may be provided on the handle unit, the catheter unit, or both. In a preferred embodiment, the catheter portion and / or transport guidewire is refractable at its distal end to facilitate navigation within the blood vessel.

  One embodiment of the system includes a refractive transport guidewire or guide catheter. The refractive guidewire may have one or more junction points so that an operator can change the shape of the distal portion of the guidewire by manipulating the proximal point of the guidewire. The guidewire is pre-arranged so that the linear shape can be changed to any of a pre-selected range of different shapes, which are brought about by adjusting the individual junction points when manipulating the proximal portion of the guidewire You may be given a shape. In this way, the guidewire may be made to its own specifications to reach different areas of the blood vessel. This is particularly important, for example, when placing an implant within a region requiring an “S” shaped path from the entry point to the target site of the implant. The introduction trial to guide the guidewire from the femoral artery to the implant target of the infamous artery is an “S” shaped navigation path that is expected to be difficult, and one example where such a refractive guidewire may be advantageous Show.

  The methods of the present invention include the deployment of implantable devices, some of which include the use of the system of the present invention. A method for manufacturing an implantable device is also provided.

  Another object of the present invention is to provide a stent deployment method that does not cause primary occlusion of the vessel in which the stent is placed.

  Another object of the present invention is to provide a stent deployment method with a guide wire and associated transport system that enters a blood vessel from a single entry site.

  An advantage of the stent delivery system of the present invention is that it does not require a space-occupying stylet and balloon catheter.

  Another advantage of the system of the present invention is that it allows for removal of the stent in addition to the position or placement adjustment of the stent during and after deployment.

  The present invention further includes the ability to deploy a stent, the ability to evaluate the suitability of deployment obtained by standard imaging methods such as radioactive dyes and fluoroscopy, or any other imaging system, The ability to check for internal leakage between the surrounding arterial walls, the ability to detach the stent from the delivery system after proper stent deployment, or, if insufficiently deployed, reposition the stent to a new location and Advantageously, it is possible to obtain satisfactory results by repeatedly adjusting the transport and release, or to provide the user with the ability to completely remove the stent.

  The present invention further integrates the side branch lumen cell with the main lumen cell so that when the side branch lumen cell is deployed within each vessel side branch, a “lock and key” mechanism is used. It is advantageous in securing the stent by limiting the movement of the main lumen and thus preventing the stent from moving within the blood vessel. More particularly, the interconnection of the side branch lumen to the main lumen is achieved by forming the side branch lumen and the main lumen with the same single wire, with the side branch lumen integrated into the main lumen. A unique wire wrap pattern is used to form the bonded mesh. Thus, once the side branch is deployed and held in place by the arterial side branch, the stent body cannot move. In addition, such “passive” fixation mechanisms can damage the cellular structure of the implant site, resulting in active fixation means such as barbs or spinal cords that can lead to smooth muscle proliferation, restenosis, or other vascular complications. Unlike hooks, it is non-injurious.

These and other objects, advantages and features of the present invention will become apparent to those skilled in the art upon reading the details of the invention which will be described in further detail below.
The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It should be emphasized that, according to common practice, the various shapes of the drawings are not to scale. On the contrary, the sizes of the various shapes are arbitrarily enlarged and reduced for easy understanding. For further clarity, some of the features of the present invention are not depicted in some of the drawings.

  Before describing the devices, systems, and methods of the present invention, it is understood that the present invention is not limited to the particular therapeutic application and implant site described, as these will vary. There must be. Furthermore, it is to be understood that the terminology used herein is for the purpose of describing particular embodiments only and is not intended to limit the scope of the invention. This is because the scope of the present invention is limited only by the appended claims.

  Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. The terms “proximal” and “distal”, when used to refer to the transport and deployment system of the present invention, should be understood to indicate a relative position or location relative to the user. That is, proximal refers to a location or location that is closer to the user and distal refers to a location or location that is further from the user. These terms, when used with reference to the implantable device of the present invention, indicate the relative position or location relative to the system when the implantable device is operatively disposed within the transportation and deployment system. Must be understood as shown. Thus, proximal refers to a location or location that is closer to the proximal end of the transport and deployment system, and distal refers to a location or location that is closer to the distal end of the transport and deployment system. As used herein, the term “implant” or “implantable device” includes, but is not limited to, devices including stents, grafts, stent-grafts and the like.

  As used herein and in the appended claims, the singular forms “a” and “the” include plural references unless the context clearly dictates otherwise. Thus, for example, the phrase “a thread” includes a plurality of such threads, and the phrase “the tubular member” includes one or more such tubular members, and is known to those skilled in the art. The equivalent is also included.

  Given a numerical range, each intermediate value between the upper and lower limits of that range is also specifically disclosed up to one-tenth of the smallest unit, unless the context clearly indicates otherwise. I have to understand that. Also included within the scope of the invention are smaller ranges between any stated numerical value or any intermediate value in a stated range and any other stated numerical value or intermediate value in that mentioned range. The upper and lower limits of these smaller ranges are each independently included or excluded within the range, and either or both of the upper and lower limits are included or both are excluded. Small ranges are also included within the scope of the present invention. However, subject to specifically excluded limits in the mentioned range. Where the stated range includes either or both of an upper limit and a lower limit, ranges excluding either or both of those included limits are also included in the invention.

  All publications mentioned in this specification are herein incorporated by reference to disclose and describe the methods and / or materials with which the publication is cited in the context thereof. The publications discussed herein are presented solely for the reason that their disclosure was made prior to the date of registration of this application. For any of this specification, it admits that the present invention is not entitled to temporally precede these inventions because these publications are prior inventions. Do not think of things. Furthermore, the publication date presented may differ from the actual publication date, and the actual date may need to be independently verified. The invention will now be described in further detail through the following description of exemplary embodiments and variants for the devices and systems of the invention. The present invention generally includes an implantable device that includes a tubular member in the form of a stent, graft, or stent-graft. The device may further include one or more branched or transverse tubular members that extend laterally from the body or primary tubular member. The present invention further includes a system for transcutaneous, intravascular transport and deployment of an implantable device to a target implantation site in the body. The implantation site may be any tubular or hollow tissue lumen or organ. However, the most typical implantation sites are vascular structures, especially the aorta. A feature of the present invention addresses applications involving two or more crossed tubular structures and is therefore particularly suitable in the treatment setting of vascular branches, such as the aortic arch and the subrenal aorta.

Implantable Device of the Invention Referring now to the drawings, and in particular to FIGS. 1A and 1B, an exemplary embodiment of the implantable device of the present invention is depicted. Each device has a primary or body tubular member and at least one laterally extending tubular branch, while the implantable devices of the present invention need not have side branches.

  FIG. 1A is a form of an implantable device 2 comprising a primary tubular portion, a body or member 4 and side branches 6a, 6b connected to the body 4 and fluidly passing through the body 4 and lateral openings in the body. And 6c. The proximal and distal ends of the main tubular member 4 terminate in a coronal or apex 8. The number of coronals or crests 8 may vary. The distal ends of the side branches 6a, 6b, and 6c terminate in coronals or crests 10a, 10b, and 10c, respectively. The number of these coronals or crests may vary. The device 2 in particular takes the shape for implantation in the aortic arch. The primary tubular member 4 can then be placed in the arch wall, and the tubular branches 6a, 6b, and 6c are placed in the anonymous artery, the left common carotid artery, and the left subclavian artery, respectively. Is possible.

  As will be described in more detail below, the deployment or attachment member of the transport and deployment system of the present invention extends through tops 10a, 10b, and 10c or from the distal end of the top of device 2 (FIG. Draw a loop through (not shown). The attachment member of the present invention is any elongate member that is releasably attached to the distal ends of various lumens of a stent, such as any thread, filament, fiber, wire, twisted cable, tube, or Although it may be any long member including other long members, it is not limited to the above. Releasable attachment means include, but are not limited to, electrolytic erosion, thermal energy, magnetic means, chemical means, mechanical means, or any other adjustable separation means.

  FIG. 1B is another form of device 12 having a primary tubular portion or member 14 and side branches 16a and 16b connected to the body 14 and fluidly passing through the body 14 and lateral openings in the body. The proximal and distal ends of the main tubular member 14 terminate in a coronal or apex 18 used as described above with respect to FIG. 1A. On the other hand, the distal ends of side branches 16a and 16b terminate in coronal or crests 28a and 18b, respectively. The device 12 takes a shape particularly suitable for implantation in the infrarenal aorta. The primary tubular member 14 can then be placed in the wall of the aorta and the tubular branches 16a and 16b can be placed in the right and left renal arteries, respectively.

  Those skilled in the art will appreciate that the implants of the present invention have any number and shape of lumens (eg, a single main lumen with no side branch lumens, a single main lumen and one or more side branch lumens). It will be appreciated that it may be. In that case, the one or more side branch lumens may be disposed at any suitable position along the major axis of the main lumen and at any angle with respect to the major axis of the main lumen; and If there are two or more side branch lumens, the lumens may be axially spaced from one another and angled circumferentially to match the target vessel in which the implant is placed. Furthermore, the length, diameter, and shape (eg, radius of curvature) of each implant lumen may be varied as necessary to match the vessel in which the lumen is placed. Typically, the main lumen has an unconstrained length in the range of about 1 cm to about 25 cm and an unconstrained diameter in the range of about 2 mm to about 42 mm. The side branch lumen has an unreduced length in the range of about 0.5 cm to about 6 cm and an unreduced diameter in the range of about 2 mm to about 12 mm. For example, for aortic applications, the unreduced length of the main lumen is typically about 8 cm to about 25 cm, the unreduced diameter is in the range of about 15 mm to about 42 mm, and the side branch lumen is in the range of about 2 cm to about 6 cm. And an unreduced diameter in the range of about 5 mm to about 12 mm. For renal artery application, the main branch lumen has an unreduced length in the range of about 2 cm to about 5 cm and an unreduced diameter in the range of about 3 mm to about 9 mm, and the side branch lumen is from about 0.5 cm. It has an unreduced length in the range of about 3 cm and an unreduced diameter in the range of about 2 mm to about 7 mm. For coronary application, the main branch lumen has an unreduced length in the range of about 1 cm to about 3 cm, and an unreduced diameter of about 2.0 mm to about 5 mm, and the side branch lumen is from about 0.5 cm. It has an unreduced length in the range of about 3 cm and an unreduced diameter in the range of about 2 mm to about 5 mm. When applied to smaller blood vessels, such as neurovascular, these sizes are naturally smaller. Various structural and functional aspects of the implant of the present invention are described more precisely below.

  Integration of therapeutic or diagnostic components or devices with the implants of the present invention may also be considered. Such devices include valve substitutes, such as heart valves (eg, aortic or pulmonary valves), and valve substitutes including venous valves, sensors that measure blood flow, blood pressure, oxygen concentration, glucose concentration, etc. However, it is not limited to these. For example, as shown in FIG. 1E, an implant 210 for treating the base of the aorta that includes a mechanical or biological substitute valve 216 used at the distal end of the main lumen 212 is provided. Device 210 further includes two smaller, generally opposing side branch lumens 214a and 214b. These side branches are adjustably aligned to be placed in the right and left coronary ostium, respectively. The length of the stent-graft may be extended by a selected distance, i.e., the stent-graft may be terminated at any location before, within, or after the aortic arch, for example, It may be selected to extend to the descending aorta. Any number of side branches may be further provided to accept the aortic side branch vessel.

  A person skilled in the art will know the intersection of two or more blood vessels (eg, bifurcated bifurcation, trigeminal, quadrilateral, etc.) or other vascular sites in the vicinity thereof, eg, the aorta-iliac junction, femoral artery— Including but not limited to popliteal junction, brachiocephalic artery, posterior spinal artery, coronary artery bifurcation, common carotid artery, superior and inferior mesenteric artery, general visceral and gastric artery, cranial artery and neurovascular bifurcation It will be appreciated that any suitable stent or graft configuration may be provided to treat the vascular site at or near the intersection.

  As described above, the implantable device of the present invention may include a stent, a graft, or a combination of both. This combination is also referred to as a stent-graft, stent-graft, or graft stent. The stents and grafts of the present invention may be made of any known material in the prior art as appropriate. The stent is preferably constructed of wire, but may be replaced by any material as appropriate. The wire stent must be elastically flexible. For example, the stent may be made of stainless steel, elgiloy, tungsten, platinum, or nitinol, but if appropriate, any other material may be used instead of these commonly used materials. Or you may use in addition to it.

  The stent may have any wire-shaped pattern if appropriate, or may be cut from a tubular or flat sheet. In one embodiment, the overall structure of the stent is fabricated from a single wire woven into an interconnect cell pattern, for example, forming a closed chain connection. The structure may have a straight cylindrical shape, a curvilinear tubular shape, a tapered hollow shape, and may have an asymmetric cell size, for example, the cell size may be along the long axis of the stent or circularly. It may vary in the circumference. In certain stent embodiments, the side branch lumen cell size gradually decreases in the distal direction. This facilitates the ability to selectively pull the distal end of the side branch lumen, which makes it easier for the physician to guide the distal end of the side branch into the designated vessel. The ends of the main stent lumen and / or one or more side branch stent lumens may be widened. The stent struts (ie, the portion of the element that forms the cell) may vary in diameter (in the wire embodiment) or may vary in thickness or width (in the sheet and cut tube embodiments). Good.

  In certain embodiments, the stent is composed of a single wire. The single wire stent configuration allows for side-branch stents and primary stents in a selected range that allows for matching to anticipated variations in the anatomy of the treatment site by selective braiding of the attachment points along the long axis of the stent. This is advantageous in that it allows adjustment of the angular orientation relative to the lumen. Such angular orientation of the side branch lumen may be along the axis, along the circumference, or both. FIG. 1C shows the implant device 20. In the implant device, the side branch lumens 24 and 26 have an angular orientation defined by an angle α relative to the main lumen 22 and an angular orientation defined by an angle β relative to each other. FIG. 1D is an end view of the implant device 20 and shows the circumferential orientation defined by the angle θ between the side branch lumens 22 and 24. Typical ranges for the various angles are as follows. That is, the angle α is about 10 ° to about 170 °, the angle β is about 0 ° to about 170 °, and the angle θ is 0 ° to 360 °. These orientations are provided by the manufacturing process and may be such that a stent with a naturally deflected orientation is provided in non-reduced, pre-deployment conditions, ie in a neutral state. One or more of these orientations may be selectively adjusted in the aforementioned angular ranges as the side branch lumens are transported and deployed within the respective vessel lumens. This design or the linear spacing between the side branch stents can be adjusted by extending and / or pre-shortening the main lumen of the stent. In addition, the side branch portion may be extensible, and an oversized stent may be placed in a smaller branch vessel, thereby allowing sufficient adhesion between the stent and the vessel wall. It should be noted that the adjustability of the stent should not compromise the radial force necessary to secure or secure the stent and / or stent-graft and to prevent migration and endoleak.

  The graft portion of the stent-graft may be made from fabric, polymer, latex, silicone latex, polytetrafluoroethylene, polyethylene, dacron polyester, polyurethane, other or suitable materials such as biological tissue. Biological tissues that may be used include extracellular matrix (ECM), acellularized uterine wall, decellularized sinus sinus intima or membrane, acellular urethral membrane, umbilical cord tissue and collagen, but these It is not limited to. Suitable extracellular matrices for use in the present invention include mammalian small intestine, stomach, urinary bladder submucosa, sheep, cow, pig, or dermis or liver basement membrane obtained from any suitable mammal . The implant material must be flexible and durable to withstand the effects of installation and use. One skilled in the art will appreciate that the implants of the present invention can be formulated in a variety of known ways, such as by weaving or by immersing the substrate in the desired material.

  Warm-blooded vertebrate submucosa (ECM) is useful as a tissue transplant material. For example, submucosal tissue transplant compositions obtained from the small intestine are disclosed in US Pat. No. 4,902,508 (hereinafter referred to as the '508 patent) and US Pat. No. 4,956,178 (hereinafter referred to as the' 178 patent). And a submucosal tissue transplant composition obtained from the bladder is described in US Pat. No. 5,554,389 (hereinafter referred to as the '389 patent). All of these (ECM) compositions are generally composed of the same tissue layer and prepared by the same method, the difference being that the starting material is on the one hand the small intestine and on the other hand the bladder. The process detailed in the '508 patent, incorporated by reference in the' 389 patent, and the process detailed in the '178 patent, as detailed in the' 178 patent, is performed at least on the mucous membrane of the small intestine or bladder. A mechanical ablation step to remove the luminal portion, ie, the inner layer of tissue, including the lamina propria (epithelium) and lamina. Mucosal detachment, scraping, or scraping destroys the epithelial cells, and the majority of the layer structure of the connecting basement membrane, and the lamina propria, at least to the level of systematic, dense connective, dense layers . Thus, tissue transplant material (ECM), conventionally recognized as soft tissue replacement material, lacks the epithelial basement membrane and consists of submucosa and dense layers.

  The (ECM) epithelial basement membrane may take the form of a single thin sheet of extracellular material that is continuous with the basal plane of the epithelial cells. A sheet of a similar type of aggregated epithelial cells forms the epithelium. Epithelial cells and their connecting epithelial basement membrane are placed in the luminal portion of the mucosa and constitute the inner surface of living, tubular and hollow organs and tissues. The epithelial cells and their connecting epithelial basement membranes are also placed on the outer surface of the organism, the skin. Examples of typical epithelium with a basement membrane include, but are not limited to, the epithelium of the skin, small intestine, bladder, esophagus, stomach, cornea, and liver.

  Epithelial cells are placed on the lumen or surface side of the epithelial basement membrane, on the opposite side of the connective tissue. For example, the connective tissue and the submucosa are disposed on the luminal remote side or the deep side of the basement membrane. Examples of connective tissue used to form an ECM that is placed on the luminal side of the epithelial basement membrane include the submucosa of the small intestine and bladder and the dermis and subcutaneous tissue of the skin. All of these materials are referred to herein as ECM or extracellular matrix and are used to coat all or any portion of the stent.

  The stent may be coated with the implant mechanically, eg, via physical or mechanical means (eg, screws, cement, fasteners, eg, sutures or staples), or friction, or implanted. It may be fixed to the piece. In addition, mechanical attachment means may be used to perform attachment to the implantation site, for example, by including means for fastening the stent to the surrounding tissue in the stent design. For example, the device may include a metal spike, anchor, hook, barb, pin, clamp, or flange or lip to hold the stent in place.

  The stent may be treated, for example, such that a cover made of ECM material adheres only to the wire but does not spread between the wire segments or within the stent cell. For example, energy, current, or heat can be applied to the wire stent structure in the form of a laser beam while the ECM is in contact with the underlying structure. It is thought that the ECM can also be adhered to the stent, just as the tissue is detached when the meat is cooked in a hot frying pan.

  The stents, grafts, and / or stent grafts of the present invention may be coated to achieve local delivery of the therapeutic agent or formulation to the disease site. Local transport requires a relatively small dose of therapeutic agent or formulation to be transported to a localized site. This is in contrast to systemic administration, which requires multiple doses and the substance is lost before reaching the target disease site.

  The submucosa is approximately 80 microns thick and consists primarily of extracellular matrix material (greater than 98%) that is cellular and acidophilic (H & E staining). Sporadic blood vessels and spindle cells consistent with fibrocytes may be randomly scattered throughout the tissue. Typically, UBS is rinsed with saline and optionally stored in a frozen hydrated state until use.

  Fluidized UBS can be prepared similar to the preparation of fluidized small intestine submucosa as described in US Pat. No. 5,275,826. The disclosure of this patent is expressly incorporated herein by reference. UBS is ground by separation, cutting, grinding, shearing, and the like. While it is preferred to grind frozen or lyophilized UBS, the suspension of submucosal tissue fragments is treated with a high speed (high shear) blender and optionally centrifuged to remove excess water. A good result can be obtained in the same manner by removing the slant and removing the water. Furthermore, the ground and fluidized tissue is solubilized by substantially digesting the urinary bladder submucosa with a protease, such as trypsin or pepsin, or other suitable enzyme for a sufficient amount of time. It is possible to form a uniform solution.

The stent coating may be UBS in powder form. In one embodiment, UBS powder form, bladder submucosa triturated under liquid nitrogen, is prepared by generating the particles in the range from 0.1 to 1 mm ^2. The granular composition is then lyophilized overnight and sterilized to form a solid, substantially anhydrous granular composition. Alternatively, powdered UBS can be formed from fluidized UBS by drying a suspension or solution of ground UBS.

  The stents, grafts, and / or stent grafts of the present invention are coated by applying a primary layer to the surface. The primary layer defines a reservoir for containing a therapeutic agent or formulation. The overlapping area between the primary layer and the active ingredient may be modified to increase the permeability of the primary tank to the active ingredient. For example, by applying a common solvent, the active ingredient and the surface layer are mixed together and the active agent becomes absorbed into the primary layer. Furthermore, the primary layer may be treated to produce a non-uniform, rough surface. This bulky region captures the active ingredient and increases the diffusion rate of the ingredient when the stent is inserted into the patient. Thus, the implant has the ability to diffuse drugs or other mediators at an adjustable rate. Further, those skilled in the art will appreciate that the present invention may provide a combination of multiple coatings, for example, the primary layer may be divided into multiple regions, each containing a different active ingredient. Will.

  The stents, grafts, and / or stent grafts of the present invention can be any therapeutic agent, composition, or drug, such as, but not limited to, dexamethasone, tocopherol, dexamethasone phosphate, aspirin, heparin, coumadin, Agents including urokinase, streptokinase, and TPA, or any other suitable thrombolytic substance that prevents thrombosis at the site of implantation may be included. Yet another therapeutic agent and drug is used as a submucosa nanosize stabilizer to increase resistance to proteolysis as a means to prevent post-embedding aneurysm development in natural decellularized vascular struts. Tannic acid, cell adhesion peptide, collagen-like peptide, stem cell growth factor, growth / anti-cell division agent, paclitaxel, epidipodophyllotoxin, antibiotics, anthracycline, mitozantrone, bleomycin, priomycin and mitomycin , Enzymes, antiplatelet agents, non-steroidal agents, heteroaryl acetic acid, gold compounds, immunosuppressive agents, angiogenic agents, nitric oxide donors, antisense oligonucleotides, cell cycle inhibitors, and protease inhibitors, However, it is not limited to these.

  The implant of the present invention may be seeded with any type of cells, for example cells including stem cells, to promote angiogenesis between the implant and the arterial wall. The method includes applying a porous coating to the device to allow tissue growth in the gaps in the implant surface. Another effort to increase the ability of the host tissue to grow and to improve the adhesion of the implant to the host tissue is to include a charged or ionic material on the tissue contacting surface of the device. As mentioned above, the stents and grafts of the present invention may be covered, or otherwise embedded, or made entirely from extracellular matrix (ECM) material. Good. Suitable ECM materials are obtained from mammalian host sources, but are not limited to small intestine submucosa, liver basement membrane, bladder submucosa, gastric submucosa, dermis and the like. Other examples of ECM materials include fibronectin, fibrin, fibrinogen, collagen, including fibrous and non-fibrous collagen, adhesive glycoproteins, proteoglycans, hyaluronan, acidic cysteine-rich secreted protein (SPARC), thrombospondin, These include, but are not limited to, tenascin, and cell adhesion molecules, and substrate metalloproteinases.

  The ECM portion of the implant is eventually reabsorbed by the surrounding tissue and assumes the cellular properties of the tissue from which it is absorbed, eg, endothelium, smooth muscle, adventitia. Nevertheless, an ECM strut having a selected configuration is operatively attached to a stent or stent-graft of the present invention at a selected location and then undergoes reorganization to restore the original tissue structure at the selected location. Form the body. For example, the ECM strut can be placed in a previously removed aortic valve opening in a form that creates the structural characteristics of the aortic valve leaflets so that the implant can perform the valve function. .

  In addition to blood pressure, blood flow, velocity, turbidity, and other physiological parameters, the stent, graft, or stent-graft of the present invention can also contain chemical molecule concentrations such as glucose concentration, pH, sugar, blood One sensor or multiple sensors for monitoring medium oxygen, glucose, moisture, radioactivity, chemical, ionic, enzyme activity, and oxygen may be included. The sensor must be designed to minimize the risk of thrombosis and embolization. Therefore, blood flow delay or cessation must be suppressed at any point within the lumen. The sensor may be attached directly to the outer surface, may be included within the packet, or may be secured within the stent, graft, or stent-graft of the present invention. The biosensor may further use wireless means for conveying information from the buried site to an extracorporeal device.

  The stent, graft, or stent-graft may be composed of an imaging material or include a marker element to facilitate proper axial alignment of the stent at the site of implantation. May be. Any suitable material that can provide radiopacity may be used, such as barium sulfate, bismuth trioxide, iodine, iodide, titanium oxide, oxidized Zirconium, metals such as, but not limited to, gold, platinum, silver, tantalum, niobium, stainless steel, and combinations thereof. The entire stent, or any portion thereof, i.e. the apex portion of the stent, may be manufactured or marked with a radiopaque material.

Device Manufacturing Method The stent of the present invention can be manufactured by various methods. One method of manufacturing a stent is by use of mandrel devices, such as mandrel devices 320, 330, and 340, depicted in FIGS. 13A-13C, respectively. Each device has at least one mandrel main component 322, 332, and 342, respectively, and a plurality of selectively disposed pinholes 324, 334, and 344, respectively. A plurality of pins (not shown) are selectively arranged inside these pinholes, or a plurality of pins are extended from the pinholes. As described in more detail below, the stent structure is formed by selectively surrounding the wire around the pin. Where the stent is to have one or more side branch lumens, a mandrel device such as device 340 is provided with at least one side mandrel 346 that extends substantially across the main mandrel 342. In so doing, the number of side mandrels preferably matches the number of side branches of the stent to be formed. The mandrel device may be modular such that side branch mandrels of various diameters and lengths are separably attached to the main mandrel. The shape of the side branch mandrel (s) as well as the main mandrel may have any shape, size, length, diameter, etc., as long as it is appropriate to form the desired stent configuration. In general, the mandrel component has a cylindrical cross-sectional shape with a constant cross-section (see FIGS. 13A and 13C), but a conical shape (see FIG. 13B) whose diameter varies along the length dimension, and a truncated cone. Alternatively, it may have an oval cross section, a curved shape, or the like.

  The pin may be permanently attached to the mandrel component, or it can be removed by itself and selectively placed in a hole formed in the mandrel component. Furthermore, the mandrel device may be configured to selectively extend and retract the pins. The number of pins, and the distance and space between the pins may be variable so that a custom pin configuration can be realized. This custom specification allows the manufacture of stents with various sizes, lengths, cell sizes, etc., using a limited number of mandrel components. For example, in one variation, the pins are arranged in an alternating pattern around the mandrel component, eg, 4 out of 8 pinholes per row are filled with pins. Alternatively, a fixed number of selected mandrels may be provided, each having its own pinhole pattern, which in turn determines its own stent cell pattern.

  To form a stent, a shape memory wire, such as a nitinol wire, having a selected length and diameter is provided. Generally, the length of the wire has a range of about 9 to about 12 feet long, but may be longer if necessary or shorter from a practical standpoint. The diameter of the wire is typically in the range of about 0.001 to about 0.020 inches. After preparing a mandrel device with a winding pin at the desired point or location above the mandrel component, the wire is wrapped around the pin in a selected direction, a selected overlapping pattern, for example, a zigzag pattern To form a series of articulated corrugated rings that provide the desired cell pattern.

  An exemplary wire wrap pattern 350 is shown in FIG. Starting from one end of the main mandrel, the wire 352 is wrapped around the pin 354 in a zigzag pattern reciprocating from one end of the main mandrel to the other end, and finally the main lumen of the stent. A cell is formed. The side branch lumen (s) is then formed using the same wire that is still attached to the mandrel device. In that case, the wire is encased in a zigzag shape toward the distal end extending distally from the base of the side branch mandrel and then back to form all of the side branch cells. The wire is then wound around the main mandrel along a path having an angle to the major axis of the main mandrel. Thus, in that path, the wire is superimposed on itself along a cell segment 356. It should be noted here that the stent lumen is manufactured first, then the others are manufactured, or the winding pattern is chosen so that various lumen sections are formed intermittently. I must.

  The mandrel device having this formed wire stent pattern is then heated to a temperature in the range of about 480 ° C. to about 520 ° C. (usually about 490 ° C.) for about 20 minutes. However, this time may be shortened by using a salt bath. The duration of the heat curing process depends on the time required to move the wire material from the martensite phase to the austenite phase. The assembly is then air dried or transferred to a water bath and quenched for at least 30 seconds and left to air dry. Once the stent is sufficiently dry, either pull the pin out of the mandrel device or activate the inner piece that causes the pin to protrude from the respective hole in the mandrel outer surface, thereby allowing the pin to move into the hollow center of the mandrel. Push back in. The stent with articulating lumen can then be removed from the mandrel device. Alternatively, the mandrel components are separated from each other, one of the lumens, eg, the main stent lumen, is first formed, and then the side branch mandrel is attached to the main mandrel and then the side branch lumen is formed. Also good.

  Optionally, the selected region of the body or the diameter of the wire portion forming the side branch lumen can be selectively reduced by etching or electropolishing to the wire portion of the stent where the wire diameter has not been reduced. In comparison, the radial force may be smaller. One example of a selective reduction in the stent body wire diameter is to leave a 1-2 cm circumferential portion of the proximal and distal ends, respectively, so that the stent does not move on the one hand A high radial force sufficient to ensure that the area is obtained, while in the central part between these high radial force areas, it is possible to reduce the cross-sectional diameter of the wire, thereby At this time, it becomes easier to extend the stent, or it is easier to place the stent small in the transport sheath over a long distance. Another example of selectively reducing the cross-sectional diameter of the wire is to make the side branch strut diameter smaller. This is accomplished during manufacture by selectively immersing the side branch in acid to reduce the amount of metal in a particular area of the stent. Another way to achieve the desired result of selectively reducing the long axis stiffness of the side branch and / or the outward radial force of the side branch component is the use of an electropolishing apparatus. Metal ions are dissolved in the electrolyte by transferring the braided solid wire stent to an electrolytic bath and applying a voltage potential across the anode-cathode gap where the stent itself becomes the anode. Alternatively or afterwards, the process can be reversed to change the mechanical properties of the selected region to the side branch or other selected region of the stent, or to the radiation defect, with the stent as the cathode. To enhance the permeability, similar or different metals in the ionic liquid, such as gold or platinum, may be electroplated. One skilled in the art of electroplating and electropolishing will recognize that there are techniques that use “strike” layers of similar materials to the substrate to enhance adhesion of the dissimilar material to the substrate. As an example, the use of a pure nickel strike layer on a nickel titanium (Nitinol) substrate, followed by bonding a gold or platinum coating to the substrate is contemplated.

  Another method of manufacturing a stent is to cut a thin-walled tubular member, such as a stainless steel tube, remove the tube portion to the desired pattern for the stent, and remove the portion of the metal tube to form the stent. It is to remain relatively intact. Stents can also be made from other metal alloys such as tantalum, nickel titanium, cobalt chromium, titanium, shape memory and superelastic alloys, noble metals such as gold or platinum.

  In accordance with the present invention, one of ordinary skill in the art can use several different methods to manufacture the stent of the present invention, for example, all of which are well known in the current prior art, It will be appreciated that various types of lasers, chemical etching, electrical discharge machining, laser cutting that cuts flat sheets and rounds them into cylinders can be employed.

  When the stent graft 360 is formed by adding an implant material 362, eg, ECM, to the stent 364 of the present invention, any method may be used to attach the implant material to the wire shape. In one variation, the implant material is attached by sutures 366. In that case, one end 370 of the graft material is sewn longitudinally to the stent frame along the long axis of the stent. In doing so, at least one knot 368 is tied to each apex of the stent to secure one end of the graft to the stent. The graft material is then stretched around the surface of the stent and the opposite end 372 of the graft is overlapped with the already attached end 370 and independently stitched into the stent frame to prevent blood from escaping. Create a leak-free surface. The graft material is pulled, but only to the extent that it conforms to stent compliance so that it does not wrinkle when the stent is expanded. Once the graft material is completely attached to the stent, the graft is dehydrated. This causes the graft to shrink and fit snugly to the stent frame just as it is heated.

Transport and Deployment System of the Present Invention Referring now to FIGS. 2A and 2B, a system 30 of the present invention for implanting a device of the present invention is shown. System 30 includes a distal catheter portion 32 and a proximal or handle portion 34. The catheter portion 32 is configured to be placed within a blood vessel or other passage leading to an implantation site and includes various elongated members having a plurality of lumens. Many of these lumens are multifunctional, for example, for guide wires, pull wires, and fluid passages from one end of the device to the other. Catheter portion 32 includes a movable outer sheath 38 having a lumen in which intermediate member 40 is received. The proximal end of the outer sheath 38 is configured to have a mating 50 for coupling with the distal hub 52 of the intermediate portion 40. The rubbing 50 is configured to have an internal valve mechanism that fluidly seals the luminal space between the wall of the outer member 38 and the intermediate agent 40, thereby preventing blood leakage. The rubbing 50 may include an injection port (not shown) for exhausting residual air that is common in catheter preparation. Inner member 42 is received and movable within lumen 138 (see FIG. 6A) of intermediate agent 40 and defines body guidewire lumen 44 for communication of guidewire 48. Inner member 42 terminates at a conical distal end 46. This point helps the device advance through the tortuous blood vessels. The outer member, the intermediate member, the inner member tube (as well as the catheter components described below) can be made from materials used to construct conventional endovascular sheaths and catheters, such as biocompatible plastics reinforced with braided materials, or It may be made of any other flexible material. However, the material is not limited to the above.

  The proximal portion 34 of the transport and deployment system 30 includes proximal and distal handle portions 36a, 36b that are axially movable relative to each other. Inner member 42 is secured to proximal portion 36a of the handle, and intermediate member 40 is secured to distal portion 36b of the handle. Its anchoring, as explained in more detail below, allows the axial separation and extension for each of the two handle portions to adjust the amount of extension and shortening experienced by the stent that is operatively loaded inside the transport system. To be done.

  As mentioned above, the transport and deployment of the implants of the present invention is performed by using a plurality of designated attachment lines, threads, wires, or filaments. A single thread, or a set, or multiple threads, is provided to adjust the implant and releasably attach each free end of the implant to the transport system. Two separate yarns or two sets of yarns are used to adjust the main tubular portion of the implantable device. One or a set of threads is for adjusting the distal end of the device and the other or the other set of threads is for adjusting the proximal end. Each side branch of the implant is provided with a further thread or another set of threads. The number of threads in each set correlates with the number of vertices or connection points provided at each end of the device (ie, the proximal and distal ends of the main stent portion and the distal end of the side branch portion). . Each thread forms a loop with a designated coronal portion, both ends of which are placed and adjusted on the handle of the device. At that time, one end of each attached yarn is permanently fixed to the transport and deployment system 30, while the other end can be releasably attached to the transport and deployment system 30. When operatively loaded within the system 30, the luminal ends of the implant are releasably attached to various portions of the system 30. For example, the distal end of the main lumen of the stent is releasably attached to the inner member 42, the proximal end of the main lumen of the stent is releasably attached to the intermediate member 40, and the distal end of each side branch stent is , Releasably attached to the designated side branch catheter 150 (see FIG. 6A).

  Each attached yarn, or each set of attached yarns, is controlled by a designated control mechanism, i.e., fixed, released, tensioned, pulled, and tightened. Accordingly, the number of control mechanisms provided in the exemplary embodiment of the system of the present invention corresponds to the number of sets of attached yarns. However, the control of the yarn set may be grouped and reduced to a smaller number of control mechanisms. Various control mechanisms are possible, but may take any form, as appropriate, and may be attached to any position in the system 30. One exemplary form and location of the control mechanism in the system is shown in FIG. 2A. In particular, each control mechanism includes a pair of controls, for example in the form of knobs, dials, switches or buttons, where one control moves the thread linearly, i.e. deploys the implant. However, the other control is to selectively release the free end of the thread prior to the deployment of the implant while the thread is moved linearly by pulling its fixed end through the deployment system 30. It is for fixing.

  Controls 70a, 70b and 72a, 72b for controlling the distal and proximal lumen ends, respectively, of the implant are provided on the handle portions 36a and 36b, respectively. A separate pair of controls for each set of attached yarns that connect to each side branch lumen of the implant is provided on a hub releasably attached to the intermediate member 40, thus collecting hubs Disposed intermittently between the proximal end 50 of the outer sheath 38 and the distal end of the distal handle portion 36b. For example, as used in the implant 2 of FIG. 1A having three side branch lumens 6a, 6b, and 6c, three hubs 74, 76, and 78, each comprising a connection control pair, are provided, In doing so, the most distal pair 74a, 74b of the control section controls the attachment thread of the distal most lumen 6a of the stent side branch lumen, and the second or middle pair 76a, 76b of the control section is intermediate. The attachment position of the stent side branch lumen 6b is controlled, and the most proximal pair 78a, 78b of the control unit controls the attachment thread of the most proximal lumen 6c of the stent side branch lumen.

  Each pair of controls includes a fixed end member 70a, 72a, 74a, 76a, and 78a, here in the form of a knob. One set of fixed yarn ends and a fixed set are permanently fixed to the member, but the yarn ends themselves can be detached from their respective handle portions or hubs, in which case the yarn is pulled by hand. Be able to. This controller maintains a constant tension on the attached yarn so that the implant is constrained within the transport system while the transport system is joined to the blood vessel. As best shown in FIG. 2B, each knob is adapted to prevent backflow of fluid, eg, blood, from the handle or hub before or after the knob is removed from the handle or hub. The hemostatic valve 80 is disposed in the inside. Each control pair also includes a releasable end member or clamp 70b, 72b, 74b, 76b, and 78b, here in the form of a dial or drive screw. With this member, the free end of the thread set is releasably secured to the respective handle portion or hub. When ready for deployment of each luminal end of the implant, the drive screw is selectively loosened, allowing the tension on the respective thread set to be released. One skilled in the art will appreciate that the relative positioning and placement of the various control mechanisms may vary with the intention to provide an organizational, ergonomic design profile.

  Referring now to FIGS. 2B, 3A, and 3B, each side branch control hub 74, 76, and 78 is coupled to a distally disposed side branch catheter hub 84, 86, and 88, respectively (in FIG. 2B, Only the hubs 78 and 88 that are arranged closest are depicted). Extending between each hub pair are proximal portions 94a, 94b, 94c of side branch catheters 150a, 150b, 150c, respectively (see FIG. 6A). Each side branch catheter passes from a sealable port 110a, 110b, 110c (see FIG. 2B) on the back of each control hub 74, 76, and 78 to a respective side branch catheter lumen 148 within the intermediate member 40 (see FIG. 6A). Through to the distal end. Within each side branch catheter 150a, 150b, 150c is a side branch guidewire lumen 152a, 152b, 152c (see FIG. 6A). Ports 110a, 110b, 110c allow side branch guidewires 154a, 154b, 154c to enter and pass through their respective side branch guidewire lumens 152 (see FIG. 6A). One or both of the side branch catheter and the side branch guidewire may be displaceable. Each control hub 74, 76 and 78 is slidably fitted to the intermediate member 40. The lower surface of the control hub has a cuff 96 taking a partial ring form or the like. This allows the hub not only to be completely released from the intermediate member 40 but also to slide on it. As described above, each side branch stent lumen is releasably coupled to the distal end of side branch catheters 150a, 150b, 150c through a designated attachment thread or set of attachment threads. Regardless of the relative position between the side branch control hubs 74, 76, 78 and the connecting side branch catheter hubs 84, 86, 88, the attachment yarns in both configurations depicted in FIGS. 3A and 3B have their respective control knobs 74b. , 76b, and 78b until fully released. When the control hub is in a distal or approximate position relative to the catheter hub, as depicted in FIGS. 2A and 3B, the proximal portions 94a, 94b, 94c of the side branch catheters 150a, 150b, 150c are connected to the catheter hub. Fully received in the side branch stent is held in a partially deployed state. In this partially deployed state, the side branch stent is held in an expanded state. At this time, by means of the respective thread or thread set of the side branch catheters through the respective extended side branch catheters 94a, 94b, 94c, which are removably attached to the apex of the elongated side branch stent or the distal end of the connection point. Tension is applied. The tension applied to the distal end of each side branch stent is transferred through the side branch stent, increasing the length on the one hand while simultaneously reducing the diameter on the other. This allows a relatively large stent diameter to be placed in a relatively small diameter side branch vessel. This partially deployed state, i.e. when the diameter of the side branch stent is smaller than the side branch vessel in which the stent is placed, allows not only blood flow around the implant but also blood flow within the implant, so During this period, downstream blood vessels and organs can be recirculated. In order to avoid ischemia for the affected downstream organs, it is preferred that blood flow continuously through the cross-branch vessels during the procedure. The side branch stent is stretched by extending a side branch catheter that is releasably attached to the coronal portion of the distal end of the side branch stent. The extension of the side branch stent then allows the stent to be placed into a smaller, target side branch vessel. Typically, the diameter of a natural, unreduced side branch stent is about 5% to about 50% larger than the diameter of the side branch vessel in which it is to be placed. Conversely, as shown in FIGS. 2B and 3A, when the control hub is in the proximal or retracted position, each side branch stent is held in a deployed or unretracted state.

  Side branch catheters 150a, 150b, 150c slide at their proximal ends 94a, 94b, 94c through hemostatic valves 92a, 92b, 92c disposed at the respective side branch catheter hubs 84, 86, 88 and the rear end of the catheter hub. Extended. Each side branch control hub 74, 76, 78 has luer joints 110 a, 110 b, 110 c (only 110 c are shown) that allow attachment of hemostasis valves (not shown). The hemostatic valve may be a Y arm adapter or a Toughy-Borst adapter. This adapter allows the guidewire to be hermetically introduced. With a Y-arm adapter, it is possible to remove air from the guidewire lumen by injecting saline into the catheter before inserting the catheter into the body. In subsequent treatment steps, this lumen may be used to introduce radioactive contrast dye to visualize the blood flow through the side branch artery.

  As shown in FIG. 4, a body port 76 disposed at the rear end of the proximal handle portion 36a has a guidewire lumen 44 extending through the central lumen 138 (see FIGS. 6A and 6B) in the intermediate member 40. Liquid. Guidewire lumen 44 provides passage and movement of primary guidewire 48. The primary guidewire 48 not only directs and guides the distal portion 32 of the system toward the target implantation site in the blood vessel, but also assists in the placement and implantation of the distal end of the primary lumen of the implantable device. The body port 76 has a luer joint similar to the luer joint 110 described above in connection with the side branch catheter control hub.

  As further shown in FIG. 4, a lever mechanism 56 is provided that extends distally and downwardly from the proximal portion 36a of the handle to steer the catheter distal portion 32 of the device 30 as it passes through the deployed vessel. This lever may be replaced by a rotatable control knob 193 as seen in another handle embodiment 194 shown in FIG. 9A. A steering pull wire, thread, or filament (not shown) is secured to the proximal end of the lever 56 and extends through the catheter portion 32, with its distal end terminating in the apical cone 46 of the inner member 42. It adheres. The lever 56 is pivotally coupled to the interior of the handle portion 36a. This coupling causes the steering pull wire to be relaxed or slack when the lever 56 is rotated downward (indicated by arrow 65a in FIG. 4). Conversely, when the lever 56 is rotated upward (indicated by arrow 65b), the steering pull wire is pulled or tensioned, so that the distal end of the inner member 42 and thus the distal end of the device 30 The edge is bent. Any number of steering pull wires may be used to selectively tension the distal end of device 30 and selectively bend it in multiple directions perpendicular to the long axis of the implantation system. Typically, the transport and deployment system of the present invention has at least one, often 2 to 4, distal inflection points. These inflection points may be a distance or a few distances away from the distal end of the catheter 32 so as to form a compound curve at the distal end of the catheter.

  Referring now to FIGS. 5A-6C, 6A and 6B, the relative placement and contact bonding of implantable devices with various catheters, lumens, guide wires, ports, and pull wires of the implant system of the present invention will be described. . 5A-5C show an implantable device 120 partially deployed from the distal end 118 of the outer sheath 38. FIG. Implantable device 120 includes a tubular body 122 and may include one or more tubular side branches 124. At the coronal or crest 126 of the body 122 and at the distal end of the coronal or crest 128 of the side branch 124 is a perforated loop 130 for receiving an attachment thread 132 (shown only in FIG. 5C). There may be. Any means can be used to loop the attachment wire at the end of the side branch 124, including passing the attachment yarn or threads through a window provided by the cell structure ending at the top. As depicted in FIG. 5C, when operatively loaded into the system 30 of FIG. 2A, the main lumen 122 of the device 120 is longitudinally disposed between the outer sheath 38 and the inner sheath 42 and is intermediate Disposed further distally than the distal end 134 of the member 40.

  To load the implant device into the outer sheath 38, the handle control is set to extend the stent by extending the distal tip 46 of the inner member 42 relative to the distal end of the intermediate member. . As shown in FIG. 8D, when the proximal and distal portions 36a, 36b of the handle are pulled apart from each other, the main lumen of the stent is stretched or tensioned. Conversely, as shown in FIG. 8E, if the proximal and distal portions 36a, 36b of the handle remain unstretched, the main lumen of the stent is not stretched or placed in an unstrained state. It is burned. The distal ends of the lumens of the inner member 42 and the intermediate member 40 provide a connection point for a thread or threads that are releasably attached to the distal and proximal stent main lumen openings 122. As previously described, the distal end of the side branch stent lumen is releasably attached to the distal end of the side branch catheter.

  6A shows a cross-sectional view of the distal portion of the implantation system taken along line AA in FIG. 5C. Specifically, this cross-sectional view is taken at the distal end of the intermediate member 40. This figure shows the nesting relationship between the outer member 38, the intermediate member 40, and the inner member 42. That is, the inner member 42 is disposed within the central lumen 138 of the intermediate member 40 and the main guidewire 48 is disposed within the central guidewire lumen 44 of the inner member 40 that extends distally from the tip 46. Is done.

  The inner member 42 is a very small diameter catheter, ranging from 3 to 8 French for cardiovascular purposes, and is disposed outside the central guidewire lumen 44 and on the circumference around the central guidewire lumen 44. A plurality of attached yarn lumens 140. This attached yarn lumen serves to direct axial alignment of the attached yarn relative to the connection point at the distal end of the main stent lumen. Multiple lumens 140 are disposed at the distal portion of member 42 and extend along the entire length of inner member 42. Lumen 140 may communicate with one or more flash ports in the handle portion of the transport system. In that case, saline can be ejected through the lumen 140 at a pressure higher than the pressure of the surrounding blood flow, thereby preventing blood flow from entering the device lumen. Lumen 140 may also be used to transport radioactive contrast dyes when the device is placed under fluoroscopic visualization. Lumen 140 and outlet port 186 allow visualization of the dye flowing through the implant at each stage of deployment, as described below, so that placement of the stent provides the desired flow pattern and treatment results. It is possible to confirm whether or not to bring.

  In another embodiment, for example, as shown in FIGS. 10A, 10B, and 10C, the attachment yarn lumen 140 is a fraction of the length of the inner member 40, eg, just a few millimeters from distal to proximal. It may be just extended. This embodiment is particularly suitable when only one attached yarn is used for multiple stent attachment points. In this case, the single thread element escapes from one of the plurality of distal lumens, passes through the stent junction, and passes distally to proximally to another one of the lumens. Escape proximally and pass distally to proximally into another one of the lumens and through another stent attachment point. This crossing pattern continues and eventually all stent attachment points are knitted with a single thread passing through multiple circumferential lumens. This attached yarn lumen configuration, which extends only a fraction of the length of the inner member, may also be used for the intermediate member 40 and side branch catheters 94a, 94b, 94c. For an intermediate member that uses such a thread lumen configuration, the proximal portion of the intermediate member 40 is a single lumen that includes an inner member 42 and a relatively short circumferential lumen is located outside the side branch catheter. It is contemplated to include an attachment wire for the proximal end of the main stent lumen. As can be seen from this embodiment and the embodiments described below, any combination of braided patterns may be used to attach an individual stent end to the respective catheter to which it is attached.

  Referring again to the embodiment of FIG. 6A, the number of distal attached yarn lumens 140 is double the number of attached yarns 132 when a pair of attached yarn lumens 140a, 140b are provided for each distal attached yarn 132. It is. Thus, when the device 120 is fully loaded into the deployment system, the first portion of the distal attached yarn 132 stays in the lumen 140a and the second or return portion of the distal attached yarn is in the lumen 140. To stay in.

  In addition to the attached yarn lumen 140, there are one or more steering pull wire lumens 142. Its function is as described above with reference to FIG. Typically, one or two pairs of diametrically oriented steering pull wires (180 ° apart) are used to achieve a right angle shift in the opposite direction at the distal end of the transport system. The more steering pull wire pairs that are used, the greater the steering direction during refraction of the transport system.

  In addition to the central lumen 138 in which the inner member 42 moves, the intermediate member 40 includes a plurality of attached yarn lumen pairs 146a, 146b. The lumen 146a is illustrated as being placed radially outward from the lumen 146b. The attached yarn that is attached or passed to the proximal coronal portion (not shown) of the main lumen 122 of the device 120 utilizes the lumen 146. The number of proximal attached yarn lumens 146 is double the number of proximal attached yarns when a pair of attached yarn lumens 146a, 146b are provided for each proximal attached yarn. That is, when the device 120 is fully loaded into the transport and deployment system, the fixed end portion of the proximal attached yarn stays within the lumen 146a and the distal or return portion of the proximal attached yarn is the lumen 146b. To stay inside.

  In addition to the attached yarn lumen 146, the intermediate member 40 is also a plurality of lumens disposed circumferentially around the central lumen 138, preferably sandwiched between the proximal attached yarn lumen pairs 146. 148 is provided. One or more lumens 148 are then used to move and transport the side branch catheter 150 (shown with details omitted in FIG. 6A). Side branch catheter 150 provides a side branch guidewire central lumen 152 for transporting and moving side branch guidewire 154. Another lumen 148 extending from the handle flush port (not shown) is provided for venting from the transport system 30. This additional lumen 148 also allows for rehydration of the solution and other coverings that need to be dispensed with therapeutic agents that are considered effective, such as pharmacological agents, stem cells, or other agents. And This allows the stent-graft, or other device, to be constrained within the delivery catheter in a dry dehydrated state, then packaged, sterilized, rehydrated by flush, and ready for use at the catheter. . Even if there is an unused lumen 148, it increases the flexibility of the intermediate member, especially if the distal end of the device can be displaced at multiple inflection points.

  FIGS. 7A, 7B, and 7C show various possible embodiments of side branch catheters suitable for use with the delivery system of the present invention. The side branch catheter 160 of FIG. 7A provides a central guidewire lumen 162 and a plurality of attached yarn lumens 164 disposed on a circumference around the central lumen 162. The lumen 164 is utilized or occupied by an attached thread (not shown) that is looped or threaded through the distal coronal 128 of the side branch lumen 124 of the device 120 (see FIG. 5A). The number of side branch attached thread lumens 164 is twice the number of side branch attached threads. That is, a pair of attached yarn lumens 146a, 146b is provided for each side branch attached yarn, i.e., when the device 120 is fully loaded into the implantation system, the proximal portion of the side branch attached location is the lumen. Stay in 164a and the return portion of the side branch attached yarn stays in lumen 164b.

  The side branch catheter 170 of FIG. 7B provides an outer member 172 having a central lumen 174 and an inner member 176 disposed concentrically therein. Inner member 176 also has a central lumen 178 for moving and transporting a side branch guidewire (not shown). External member 172 also provides a plurality of side branch attachment thread lumens 180. In this case, there is a one-to-one correspondence between the number of side branch attached yarn lumens 180 and the number of side branch attached yarns (not shown). In this embodiment, the proximal portion of the side branch attachment yarn stays in a space between the inner diameter of the outer member 172 and the outer diameter of the inner member 176, and the distal attachment loops the eye, coronal portion, or cell. After passing through, the distal or return portion of the thread passes through the lumen 180 of the outer member 172.

  In another embodiment of the side branch catheter 200 shown in FIG. 7C, the side branch catheter is comprised of two concentric single lumens. A single lumen tube 202 that defines an inner diameter and another single lumen tube 203 that defines an outer diameter are contained in a space 201 between the inner diameter of the outer tube 202 and the outer diameter of the inner tube 203. Prepare side branch attachment yarn. The inner diameter of the inner tube is used to move a guidewire (not shown) through the side branch guidewire lumen 204, separated from the attached yarn, as shown in FIG. 7C. This lumen configuration may also be employed for intermediate members and internal members.

  Referring to FIG. 6B, there is shown a cross-sectional view taken through the proximal end of the distal tip 46 taken along line B-B of FIG. 5C, specifically the inner member 42 terminates. The distal tip 46 not only provides the distal portion of the guidewire lumen 44, but also provides the distal lumen portion 182 of the distal attached yarn lumen 140 of the inner member 42. In this cross section, the plurality of distal lumen portions 182 are axially aligned and have a one-to-one correspondence with the internal member attachment thread lumen 140. Thus, for each distal attached yarn 132, the same pair of adjacent attached yarn lumens 182a, 182b is provided, i.e., the fixed end portion of the distal attached yarn 132 stays within the lumen portion 182a and is distant. The releasable or return portion of the staple yarn stays within the lumen portion 182b. As best depicted in FIG. 6C, after passing through the lumen portion 182a, the attachment thread 132 exits radially from the distal tip 46 and passes through the designated proximal side port 184. This attached thread then loops or passes through the eyelet 130, around the coronal or crest 126, or through a very distal cell of the main lumen 122, to the designated side of the distal tip 46. Return through port 184. In doing so, the thread reenters each lumen portion 182 and each attached yarn lumen 140. Thus, for each attached yarn lumen pair, there are half the number of side ports 184, ie, there is a one-to-one correspondence between the number of attached yarns 132 and the number of distal tip side ports 184. The distal tip 46 also provides a distal side port 186 to facilitate thread loading during attachment of the implant to the delivery system.

  The catheter and / or guidewire used with the system of the present invention may include intravascular ultrasound (IVUS) imaging capabilities. In doing so, one or more miniaturized transducers are mounted at the tip of the catheter or guidewire to provide electronic signals to an external imaging system. Such a transducer array may be rotated to generate an image of the arterial lumen. The image then shows the connected branch vessel that receives the connected branch stent, or other precise location of the starting point of the lumen into which the catheter is inserted, the vascular tissue, and / or the tissue surrounding the vessel. Such a system not only aids in visualization during stent delivery and deployment, but also provides important diagnostic (ie pre-stent) information such as the location and size of the aneurysm that is not available with conventional x-ray angiography To enhance the effectiveness of diagnosis and treatment. Intravascular ultrasound (IVUS) imaging catheters generally include, for example, confirming that a side branch vessel is not mishandled for several reasons before installing an unbranched stent, Used as a preparatory step in the selection process of the appropriate size stent graft. Combining imaging capabilities with the tip of the stent delivery catheter has the advantage of saving time because catheter replacement is avoided. A commonly taken technique to avoid exchanging the stent delivery catheter and the IVUS catheter through the entry site is to acquire another entry point for introducing an independent IVUS catheter. By incorporating an IVUS transducer at the tip of the stent delivery catheter, the imaging catheter can be dispensed with a second vessel entry trauma that is required if it must be delivered from one of the bilateral inguinal entry sites. it can. In addition, when placing one stent in another, it is ascertained whether the second stent is deployed redundantly within the lumen of the first stent and extends to the desired length of the treatment area. IVUS catheters are used. In such a case, when the first stent is installed, the downstream portion may be free floating in the cyst of a large aneurysm. In such a case, care must be taken to ensure that the second stent is placed within the first stent and does not exit the lumen of the first stent. Failure to do so will unintentionally occlude the blood vessel, which necessitates conversion of the procedure to surgery to remove the misplaced second stent.

Device Embedding Method The device embedding process of the present invention will now be described with reference to FIGS. 8A-8H in the context of applying an aortic arch to a stent-graft. A stent graft 2 of the present invention, similar to that depicted in FIG. 1A, having one main lumen 4 and three side branch lumens 6a, 6b, and 6c is percutaneously inserted into the aortic arch 5. Buried. As shown in FIG. 8H, when implanted, the main lumen 4 stays in the aortic arch 5, and the three side branch lumens 6a, 6b, and 6c are respectively an anonymous artery 7a, a left common carotid artery 7b, and It stays in the left subclavian artery 7c.

  Using the Seldinger technique via the left femoral artery 8 or by abdominal aortic incision, the main or aortic guidewire 48 is routed from the aortic arch 5 via the blood vessel, and finally, as shown in FIG. Proceed until traversing the aortic valve 10. Next, the catheter portion 32 of the implantation system 30 of the present invention, with the stent graft 2 operatively loaded therein, is percutaneously introduced over the guidewire 48 into the patient's body.

  Note that stent grafts or other materials, such as stents that are coated with ECM, may require reconstruction or hydration of the graft or covering before initiating the implantation procedure. Should. This reconstruction or hydration is accomplished by injecting saline into the guidewire lumen of the delivery system catheter before inserting the catheter into the body. Alternatively, it can also be achieved by irrigating in open air prior to fitting the sheath.

  While the stent-graft 2 is loaded and undeployed within the catheter 32, the handle of the transport system is in the retracted position, i.e., the proximal portion 34a of the handle and the distal portion 34b of the handle fit together. To do. When the handle is in the retracted position (shown in FIGS. 8B and 8D), the inner member 42 is in the distally advanced position and the intermediate member 40 is in the proximally retracted position. This axial relative positional relationship between the intermediate member and the inner member maintains the stent-graft 2, or at least its main lumen 4, in an elongated or tensioned state. As such, the distal coronal portion of the main lumen 4 is attached to the distal end of the inner member 42, which is secured to the proximal portion 34a of the handle, and the main lumen 4 This is because the proximal coronal portion is attached to the distal end of the intermediate member 40, which is secured to the distal portion 36b of the handle.

  The catheter portion 32 is then steered as required by the operating lever 56, whereby the distal tip of the catheter 32 is refracted and into the descending aorta and then the aorta, as described above with reference to FIG. Advance to bow 5. The catheter portion is rotationally suitable so that the side branch lumens 6a, 6b, and 6c of the stent-graft 2 are substantially aligned with the arteries 7a, 7b, and 7c to be transported, respectively. It is important to be placed. For this purpose, the catheter 32 is rotationally movable and fluoroscopic guidance may be employed to further assist in the transport of the catheter portion 32. In particular, to achieve optimal placement in each artery, a fluoroscopic marker (not shown) in the coronal portion of the stent graft lumen may be tracked and accurately positioned. The stent itself may be radiopaque. The tip of the catheter may be radiopaque as well. A steerable guidewire may be used to direct the main catheter 32 and side branch catheter. This is because the stretched main stent body and side branch stent body are steered by a guide wire having a displaceable tip placed at the target implantation site.

  Through this transport and deployment procedure, the various lumens of the catheter portion 32 are in the opposite direction (relative to the blood flow) at a pressure greater than or approximately equal to the arterial blood pressure by a fluid, such as a saline or contrast agent. It is flushed continuously. This not only prevents the leakage of blood from the system, but also prevents interference with the function of the transport process, in particular, the stent thread lumen is completely free from blood invasion, so that blood coagulation in the lumen is prevented. Eradicated. Further, each lumen end of the stent-graft (ie, the proximal and distal ends of the main lumen 4 and the distal end of the side branch lumen) is individually controlled by the transport and deployment system 30 of the present invention. (On the other hand, some or all of them may be controlled together) so that the stent interconnect cells are selectively extended in the axial direction, so that the device can be deployed even within the anatomy. Continuous blood flow around is possible. This axial extension property also allows a side branch stent with a larger diameter to be implanted in a vessel with a smaller diameter.

  Once the catheter portion 32 has been operatively positioned within the aortic arch 5, the outer sheath 38 is pulled back by manually pulling the joint 50 (see FIG. 3A), and the inner member 42 as shown in FIG. 8C. The proximal end of the leading cone 46 is exposed and the distal portion of the main or aortic lumen 4 of the stent-graft 2 is partially deployed in the ascending aorta. With partial deployment of the stent graft 2, i.e., when the main aortic lumen 4 is maintained in the stretched or tensioned state, arterial blood flow leaving the aortic valve 10 flows in or around the main lumen 4. When the main lumen 4 is in this partially deployed state, the stent-graft 2 is not yet mated with the vessel wall, so that inadvertent endothelial damage and / or plaque embolism may occur. Of course, it is important to note that it can be easily repositioned inside the vessel because it does not suffer from the frictional resistance brought about by contact with the wall.

  The various side branch lumens 6a, 6b, and 6c of the stent-graft 4 may be deployed from one to the next (one at a time) in any order, or in parallel (simultaneously) together. The side branch stent lumens may be deployed one at a time in order from the most distally located stent lumen (6a) to the most proximally located stent lumen (6a). It is easiest to deploy. This deployment sequence eliminates the need to repeatedly move the outer sheath 38 unnecessarily over the stent-graft. That is, only gradual, unidirectional (proximal) movement is required. This is advantageous in that it reduces scratches on the graft material. This is particularly important when the stent is coated with a material, such as an extracellular matrix or drug. This deployment sequence further reduces the required deployment process and thus reduces the total time required for the embedding process.

  To deploy a side branch stent lumen, eg, stent lumen 6a, a side branch guidewire 154 is inserted into the side branch port 110 of the respective control hub in a position where the control hub has been advanced fully distally ( Alternatively, it may be preloaded) and then advanced through the lumen 152 of the side branch catheter 150 disposed within the lumen 148 of the intermediate member 40 (see FIG. 6A). At the same time, the outer sheath 38 is withdrawn gradually and slowly in the proximal direction. This allows the distal end of the guidewire 154 to move through the side branch catheter 150, as shown in FIG. 8C, out of its distal end, and enter the anonymous artery 7a. Each control hub 74 may then move distally along the intermediate member 40 and fully mate with the connecting catheter hub 84. At this time, as shown in FIG. 8D, the maximum tension given to the side branch stent cell is applied via the attached attached yarn, and the side branch stent 6a is partially deployed. While the main stent cell is being pulled from distal to proximal by the relative position of the inner member and the intermediate member while still being controlled by the approaching handle, the side branch stent is similarly distant. Note that the extended position is maintained by the laterally advanced side branch catheter. This process applies to the remaining number of side branch stents, in this case for side branch stents 6b and 6c transported to the left common carotid artery 7b and left subclavian artery 7c, respectively, as shown in FIG. 8D. Is repeated as necessary. In this partially deployed state, the blood will move around the device depending on how tight and how long the adherent thread is pulled against the outlet port 184 of the inner member. Not only flows in the implant. Although it may be desirable to prevent blood flow only around the device and not through the device lumen, this may cause the attachment thread at the distal end of the main lumen to minimize attachment length. Drawing is achieved by the abutment of the main lumen of the stent-graft against the distal tip 46 or inner member 42. The distance between the distal end of the main stent and its connection to the inner member adjusts the position at which the clamp is locked to the distal attached yarn by the length of the distal attached yarn controlled by the yarn clamp 70b. It is important to note that control is possible by selection. This adjustment can be performed while the stent is being transported and remains attached to the living body. Similarly, the distance between the proximal end of the main stent and its connection point to the intermediate member is also locked by the length of the proximal attached yarn controlled by the yarn clamp 72b to lock the clamp to the proximal attached yarn. Control is possible by adjusting and selecting the position. This adjustment can be performed while the stent is being transported and remains attached to the living body.

  Once all of the side branch stents have been placed in the branch artery in the partially deployed state, the stent graft is ready for full deployment. This is accomplished by moving the handle of the system to the extended position, ie, moving the handle proximal portion 34a and the handle distal portion 34b axially away from each other, as shown in FIG. 8E. This action causes the inner member 42 to move proximally relative to the fixed intermediate member 40, and then the tension applied to the cells of the main lumen 4 is relieved so that both The ends approach. Thus, the stent is shortened and a corresponding increase in diameter occurs in the main lumen 4, so that the main lumen 4 is fixed relative to the aortic wall.

  The side branch catheters are similarly moved proximally by moving their respective control hubs 74, 76, 78 away from the corresponding catheter hubs 84, 86, 88, so that they are applied to the cells of the side branch stent. The tension is relaxed. Accordingly, as both ends of the lumen are shortened, there is a corresponding increase in the diameter of the side branch lumens 6a, 6b, 6c. The distance between the stent end and the catheter end adjusts the length of the thread traversing between the fixed end knobs 70a, 72a, 74a, 76a, 78a and the releasable end clamps 70b, 72b, 74b, 76b, 78b. It is important to note that control is possible.

  When the stent cell is released from its tension by movement of the catheter handle and side branch catheter and the stent opens to a diameter that expands enough to abut the surrounding arterial wall, the entire blood flow enters the distal end of the device. , Out of all other lumens. After the stent is fully deployed, the blood flow is preferably sealed from the outer periphery of the stent-graft.

  While the stent itself is fully deployed as shown in FIG. 8E, the stent is still attached to the inner member 42, intermediate member 40, and each distal end of each side catheter 150a, 150b, 150c by the attached yarn set. To be attached. Next, the luminal end of the stent graft is removed from the respective catheter. The lumen ends of the stent-grafts may be released from one to the next (one at a time) or in parallel (simultaneously) in any order. As shown in FIG. 8E, the lumen ends of the side branch lumens 6b and 6c are released, and at the same time, the respective attached yarn 190, the side branch catheters 150a, 150b, and 150c, and the side branch guide wire 154 are pulled out. For each side branch lumen end, for example, with particular reference to side branch lumen 6a, catheter separation activates designated control clamps 74b, 76b, and 78b in the respective catheter hubs 74, 76, 78, and catheters Release the free end of the thread 190 from the screw clamp on the hub, and at the same time remove the control knobs 74a, 76a, 78a from the handle, and the free end of the thread will unloop from the respective stent crown 128 in FIG. 8F. This is accomplished by pulling the thread 190 to such an extent that it is pulled or released. The thread 190 may be pulled until its free end releases the coronal portion and may be drawn into the distal end of the catheter portion 32.

  A similar process is performed for the deployment of the distal and proximal ends of the main lumen 4, as shown in FIG. 8G. At that time, either end may be deployed first, or both ends may be deployed simultaneously. Activating the designated control clamps 70b, 72b to release the free end of the thread 192 and at the same time remove the control knobs 70a, 72a from the handle so that the free end of the thread is unlooped from the respective stent crown 126. Alternatively, the thread 192 is pulled to such an extent that it leaves. The thread 192 may be pulled until its free end releases the coronal portion and may be drawn into the distal end of the catheter portion 32. Next, as shown in FIG. 8H, the entire catheter portion 32 is removed from the blood vessel, while the stent-graft 2 is left in the aortic arch 5 in a fully deployed state.

  Referring now to FIG. 11, the partial deployment process of the foregoing process is depicted with respect to the transport and deployment of the implant 210 of FIG. 1E. Specifically, the catheter portion 38 of the delivery system is placed in the aorta, the distal portion of the main stent lumen 122 is partially deployed in the aortic root and the ascending aorta 240, and the side branch lumens 214a and 214b are Deployed partially within the right and left coronary ostia 220 and 222, respectively. A main guidewire 218 extends from the catheter 38 and traverses the position in front of the natural aortic valve 224, while side branch guidewires 226 and 228 extend from the side branch catheters 230 and 232, respectively, into the coronary ostium 220, 222. . Simultaneously with the release of the attached thread in the main lumen of the implant, the prosthetic aortic valve 216 is placed in the natural annulus 224. The side branch lumens 214a, 214b may be deployed with each other and with the main lumen 212, or may be deployed from one to the next in any order.

  Whatever surgery or endovascular procedure is just described, the fewer incisions made in the patient's body, the better. Of course, this requires highly specialized equipment and tools used by highly skilled surgeons or physicians. In view of this, in order to facilitate the initial transport of the catheter portion 38 of the transport system 32 to the implantation site and to ensure proper orientation of the stent-graft during deployment at the site, the single section described above is used. The retracting device implantation procedure may be modified to include the formation and use of one or more secondary incisions.

  The two-cutting (or multiple cutting) procedure of the present invention comprises a primary cut, such as the above described femoral artery through which the above described transport and deployment system is introduced into a first blood vessel in the body, such as the aortic arch. And a secondary incision (or more) at the site (s) that allows access to and at least one blood vessel intersecting the first blood vessel, eg, one of the side branches of the aortic arch Including. This procedure will now be described in the context of implanting the stent-graft 2 of the present invention in the aortic arch with reference to FIGS. 12A-12F. In doing so, the implant is made in the primary incision made in the left femoral artery 8 to reach the aortic arch 5 and in the brachiocephalic artery or radial artery 15 to reach one or more arteries originating from the aorta. Done using a single secondary cut.

  First and second entry incisions are made in the left femoral artery 8 and the left brachiocephalic artery 15, respectively. With the Seldinger technique, a secondary or “tethered” guidewire 300 is advanced into the left brachiocephalic artery 15 and into the anonymous artery 7. Next, as shown in FIG. 12A, the guidewire 300 is further advanced to the aortic arch 5, descending aorta 11, abdominal aorta 13 and left femoral artery 8, where the guidewire is removed from the femoral incision. Get out of the body. A secondary or “tethered” wire 302 then follows along the long axis of the guidewire 300 from above the femoral end 300a of the guidewire 300, and finally the guidewire 302 is shown in FIG. 12B. , Get out of the arm head cut. Where appropriate, any legacy system for cardiovascular applications can be employed for use as a secondary or anchoring wire and catheter. A double lumen rapid exchange (RX) catheter may be used that places a second lumen at the proximal end of the catheter 302, such as that shown. The advantage of RX catheters is that they can eventually escape the lumen if they push the thread (s) (or guidewire) for a relatively short distance (almost no “pushability” is required), At longer distances, the thread is considered impossible to push because of its vulnerability. Alternatively, as shown in FIG. 12C, a through hole or a transverse hole may be provided in the wall of the end of the catheter 302 itself.

  Next, the aforementioned embedment system 30 with the stent graft 2 operatively loaded therein is supplied. As shown in FIG. 12C, for this procedure, the most distally located side branch stent lumen 6a (ie, the stent lumen intended for implantation in the unnamed artery 7a) is attached to it. A plurality of side branch attachment yarns 190 (at one or more stent crowns), or at least one of them, are extended from the side chain catheter 150a of the primary or stent delivery system catheter 38 and then side chain anchoring tubes 35 is passed through. The thread is then tied 37a to prevent it from being pulled back into the catheter 150a and tube 35 in the proximal direction. The remaining distal length of the thread 190 is then passed through the exchange lumen 304 of the anchoring catheter 302. The yarn ends are then re-tied 37b to prevent the yarn from being pulled proximally out of the exchange lumen 304. In the secondary catheter embodiment of FIG. 12C ′, the thread is passed through the main lumen 302 and out of the side lumen 305. Next, the distal end of the thread is tied 37b.

  A secondary catheter 302 having the entire stent catheter 38, including the primary or main guidewire 48, outside the side branch catheter 150a towing back, is returned back over the secondary guidewire 300 from the femoral incision, and finally As shown in FIG. 12D, the catheter 302 is fully withdrawn from the brachial incision, and the distal end of the side branch catheter 150a is also popped out of the brachial incision. Here, the mooring guidewire 300 is removed from the living body. At this point, the thread 190 is cut at a location 307 between the side branch catheter 150a and the opposite end of the secondary catheter 302, releasing the anchoring catheter 302 from the stent deployment system.

  Due to the tension applied to the thread 190 and the movement of the thread, the side branch 6a of the stent-graft 4 has been partially deployed (ie exposed but stretched) as depicted in FIG. 12E. State) is drawn into the anonymous artery 7a. At the same time, the stent guide wire 48 is advanced over the aortic arch 5 and further across the aortic valve 10. For this purpose, the leading cone 46 and thus the partially deployed (ie exposed but stretched or tensioned) main stent lumen 4 is introduced into the ascending aorta. Meanwhile, the stent catheter 38 follows the stent guide wire 48 and enters the aortic arch 5. Continuous advancement of the stent catheter 38 is prevented by the partially deployed side branch lumen 6a. As described above, various advantages are obtained when the main lumen 4 is in the stretched or tensioned state (similar to the side branch lumen 6a). That is, arterial blood flowing out of the aortic valve 10 is allowed to flow into the brain and body, the stent-graft 2 can be repositioned, and endothelial damage and / or plaque embolism from the aortic wall The possibility of illness is greatly suppressed.

  As shown in FIG. 12F, the stent and stent graft having two or more side branch lumens 6a, 6b, 6c are described above with respect to the implantation of a stent with a single side branch lumen and depicted in FIGS. 12A-12E. Are simultaneously performed by separately designated anchoring guidewires and catheters 150a, 150b, 150c. As shown in FIG. 12F, when at least the distal end of the main stent lumen 4 is correctly positioned and partially deployed in the ascending aorta, the side branch lumens 6a, 6b, 6c, respectively, are anonymous. Deployed within artery 7a, left common carotid artery 7b, and left subclavian artery 7c. Alternatively, as described above with respect to FIGS. 12A-12F, one or more side branch lumens may be partially deployed and the remaining side branch lumens, if any, related to FIGS. 8C and 8D. And may be deployed as described above. Finally, if all of the side branch lumens 6a, 6b, 6c are partially deployed within their respective arteries, the procedure described above in connection with FIGS. The cavity may be fully deployed and the transport system removed from the body.

  While the implant of the present invention has been described as deployable by an elongate member, i.e., a thread, the implant of the present invention may take a form configured for deployment with a single expandable member or multiple expandable members. It is understood. For example, by placing each end of a loaded, undeployed implant (ie, the ends of the main lumen and side branch lumen (s)) around an expandable balloon attached to the catheter (s) 1 It may be connected to more than one nested catheter. A partially or fully expanded balloon fits snugly into the implant end so that the lumen of the implant is selectively stretched or pulled along its length as the catheter component is manipulated.

  The foregoing description merely describes the principles of the present invention. Those skilled in the art will be able to devise various arrangements that are clearly described and not illustrated but that embody the principles of the invention and fall within the spirit and scope of the invention. It will be understood that. Moreover, all of the examples and conditional statements described herein basically help the reader to understand the principles of the invention and the concepts that the inventors have contributed to further advance the prior art. It should be understood that this is intended and not intended to be limited to this specifically described example and conditions. Furthermore, specific examples, including the text of this specification that describes the principles, aspects, and embodiments of the invention, are intended to include both structural and functional equivalents thereof. Furthermore, such equivalents are intended to include both currently known equivalents and equivalents developed in the future, i.e. any development element that performs the same function, regardless of structure. Is done. Accordingly, the scope of the invention is not intended to be limited to the exemplary embodiments shown and described herein. Rather, the scope and spirit of the invention is embodied by the appended claims.

FIG. 1A shows an embodiment of the implant of the present invention in a natural, deployed state. FIG. 1B shows another embodiment of the implant of the present invention in its natural, deployed state. FIG. 1C shows another embodiment of an implant in which the side branch lumen is angled. FIG. 1D shows an end view of the implant of FIG. 1C. FIG. 1E illustrates another embodiment of the implant of the present invention, wherein the implant is operatively coupled to a heart valve. FIG. 2A is a perspective view of a system of the present invention for transporting and deploying an implant of the present invention within a tubular tissue structure within the body. 2B is an enlarged perspective view of a portion of the system of FIG. 2A including a side branch control and a catheter hub. 3A and 3B are side views of the side branch control and catheter hub in the open and closed configurations, respectively, of the system of FIGS. 2A and 2B. 4 is a side view of the handle portion of the system of FIG. 2A. FIG. 5A is a side view of the distal end of the transport and deployment system of the present invention. The implantable device of the present invention is shown exiting the implantation system and partially deployed. FIG. 5B is a plan view of the system and implantable device of FIG. 5A. FIG. 5C shows a longitudinal cross-sectional view of FIG. 5B. 6A is a cross-sectional view taken along line AA in FIG. 5C. 6B is a cross-sectional view taken along line BB in FIG. 5C. 6C is a longitudinal cross-sectional view of the catheter tip portion of the delivery and deployment system of FIG. 5C. 7A, 7B, and 7C are cross-sectional views of possible embodiments of the side branch catheter of the present invention. 8A-8H illustrate the various steps of the inventive method for transporting the inventive stent according to the inventive embedding system. FIG. 9 shows another embodiment of the handle portion of the transport and deployment system of the present invention. FIG. 10A shows a side view of an embodiment of the internal member of the catheter portion of the delivery and deployment system of the present invention. FIG. 10B shows a cross-sectional view of the internal member of FIG. 10A taken along line BB of FIG. 10A. FIG. 10C shows a cross-sectional view of the internal member of FIG. 10 taken along line CC in FIG. 10A. FIG. 11 shows a partial deployment of the implant of FIG. 1E within the aortic root. 12A-12F illustrate various steps of another method of the present invention for transporting a stent of the present invention using the implantation system of the present invention. 13A-13C show various exemplary mandrel designs for manufacturing the stents and stent-grafts of the present invention. FIG. 14 illustrates an exemplary wire wrap pattern for forming the stent of the present invention. FIG. 15 illustrates one way of attaching the graft to the stent of the present invention.

Claims (17)

A system for transporting and deploying a stent having a distal end and a proximal end and a structure between them with an initial profile that can be reduced along its length comprising:
A catheter having a lumen smaller than the diameter of the stent in the initial profile and having a lumen adapted to receive the reduced profile stent;
At least one thread coupled to the catheter and configured to be releasably attached to the stent;
A mechanism for selectively tensioning the at least one thread to selectively increase and selectively reduce the profile of the stent;
Including said system.   The system according to claim 1, wherein the tension applying mechanism selectively tensions the at least one yarn by pushing out the yarn.   The system according to claim 1, wherein the tension applying mechanism selectively tensions the at least one yarn by pulling the yarn.   The system according to claim 1, wherein the tension applying mechanism is connected to a handle provided at a proximal end of the catheter.   5. The system of claim 4, wherein the handle includes means for articulating the distal end of the catheter at least in a direction.   The system of claim 4, wherein the tensioning mechanism includes a dial rotatable on the handle.   The system of claim 1, wherein the catheter portion includes a plurality of lumens, and wherein the thread is movable within at least one lumen.   The system of claim 1, wherein the catheter includes a lumen for selectively flushing the catheter with a fluid.   The system of claim 1, wherein the tensioning mechanism is capable of partially deploying the stent.   At least one thread configured to be releasably attached to the distal end of the stent and at least one thread configured to be releasably attached to the proximal end of the stent. The system of claim 1. The stent structure includes a main lumen and at least one side branch lumen extending laterally from the main lumen and having a distal end;
At least one thread adapted for releasable attachment to the distal end of the at least one side branch lumen;
A mechanism for selectively tensioning the at least one side branch;
The system of claim 1 further comprising: A system for transporting and deploying an implant at a vascular site in the body having at least one main blood vessel and at least one crossed side branch, the implant comprising a proximal end and a distal end defining a length therebetween A main lumen having a distal end and at least one side branch lumen extending from the main lumen and having a distal end and a length, the system comprising:
A plurality of first threads releasably attached to a distal end of the main lumen;
A plurality of second threads releasably attached to a proximal end of the main lumen;
A plurality of third threads releasably attached to a distal end of the at least one side branch lumen;
A system characterized by including. A guide wire for selectively adjusting the length of the main lumen;
The system of claim 12, further comprising: a guide wire for selectively adjusting a length of the at least one side branch lumen.   14. The system of claim 13, further comprising a catheter capable of loading the implant therein prior to deployment within the body. A system for transporting and deploying an implant within a body vessel or tubular structure within a body, the implant having a distal end and a proximal end defining a length therebetween, and a diameter, ,
A first catheter configured to slidably retain the implant therein;
A second catheter that is substantially axially aligned with respect to the first catheter;
At least one thread configured to be releasably attached to the implant;
A system characterized by including.   16. The system of claim 15, wherein both catheters further comprise a trackable guidewire.   The system of claim 16, further comprising at least one second guidewire to which one end of the implant is releasably attached.

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