JP2008526380A - Vascular graft and method for producing the same - Google Patents

Abstract

The present invention relates to vascular implants and methods of making the same. Implantable devices include, but are not limited to, stents, grafts, and stent-grafts. The device can include a biomaterial such as an extracellular matrix that is coated or connected to at least a portion of the device. The device can be composed of a single woven wire and can form at least one main lumen having a proximal end and a distal end. In many embodiments, the device includes one or more side branch lumens interconnected with the main lumen.
[Selection] Figure 1A

Description

RELATED APPLICATIONS The present invention claims the benefit of US Provisional Patent Application No. 60 / XXXX, filed Jan. 4, 2006; and US Provisional Patent Application No. 60 / 752,128, filed Dec. 19, 2005. In addition, US Patent Application No. 11 / 033,479, filed January 10, 2005, and US Patent Application No. 11 / 241,242, filed September 30, 2005, Are continuation-in-part applications, which are incorporated herein by reference in their entirety, and where there is a conflict with a prior application, this application shall govern and for those applications we shall 35 Claims priority under USC § 120.

  The present invention relates to the treatment of vascular diseases such as, for example, aneurysms, ruptures, pseudoaneurysms, dissections, elimination of vulnerable plaques, and the treatment of occlusive conditions, more specifically, the present invention relates to transplantation It relates to a possible device and a method of making it.

  In the prior art, it is well known to treat vascular diseases with implantable stents and grafts. For example, it is well known in the art to insert a stent that can be self-expanding or balloon-expanded into a stenotic or occluded portion of an artery. Similarly, use grafts or stent grafts to repair highly damaged or fragile parts of blood vessels, especially the aorta, thereby ensuring blood flow and reducing the risk of aneurysms or ruptures It is also well known in the prior art.

  More difficult situations when it is desirable to use a stent, graft or stent graft at or around the intersection between a main artery (eg, abdominal aorta) and one or more crossing arteries (eg, renal artery) Occurs. The use of uniaxial stents or grafts can effectively contain or occlude blood flow in a para-organ such as the kidney. US Pat. No. 6,030,414 deals with this situation and has a lateral opening for alignment with the paravascular flow passage extending from the main vessel in which the stent-graft is placed. The use of a stent graft is disclosed. The lateral openings are pre-positioned within the stent based on confirmation of the relative placement of the lateral vessels that are aligned with them. US Pat. No. 6,099,548 discloses a multi-branch graft and a system for deploying it. In practice, implantation of the graft is involved, requiring a separate balloon deployable stent to secure each side branch of the graft within the designated branch artery. Furthermore, they occupy space within the vasculature and require multiple probe needles to deliver the implant, thereby reducing the system's adaptability for implantation into smaller vessels. Further, graft and stent delivery requires access and exposure to each branch vessel where the graft is to be placed by a secondary arteriotomy. Although these techniques are effective, they are cumbersome to use and implement, especially if the transplant site includes two or more blood vessels that intersect the main blood vessels, all of which require a transplant. Can be somewhat difficult.

  The use of bifurcated stents to treat abdominal aortic aneurysms (AAA) is well known in the art. These stents have been developed specifically to address problems arising in the treatment of vascular defects and / or diseases at or near bifurcation sites. The bifurcated stent is typically constructed with a “pants-type” design comprising a tubular body or main trunk and two tubular legs. Examples of bifurcated stents are provided in US Pat. No. 5,723,004 and US Pat. No. 5,755,735. A bifurcated stent can have either a unitary structure or a modular structure in which the components of the stent are interconnected in situ. In particular, one or two leg extensions can be attached to the main tubular body. Due to the smaller size of the construction material, delivery of the modular system is less difficult, but it is difficult to align and interconnect the legs with body lumens with sufficient accuracy to avoid any leakage It is. Unit stents, on the other hand, reduce the probability of leakage, but are often difficult to deliver to treatment sites with limited geometry due to their larger structure.

  Conventional bifurcated stents have been used with some success in treating AAA, but they cannot be applied when the implantation site is within the aortic arch. The aortic arch region is subject to very high blood flow and pressure, making it difficult to place a stent-graft without stopping the heart and placing the patient on cardiopulmonary bypass. In addition, even if the stent-graft can be placed correctly, the stent-graft must be secured in a manner that can withstand the constant high blood flow, pressure, and shear forces provided over time to prevent migration or leakage. Don't be. In addition, the aorta undergoes relatively significant changes in diameter (about 7%) due to vasodilation and vascular restraint. Thus, if the aortic arch graft cannot expand and contract to accommodate such changes, the seal between the graft and the aortic wall may be inadequate, move and / or move Serious leakage. Further, the complexity (eg, high degree of curvature) and variability of the aortic arch anatomy by humans makes positioning for placement of stent grafts difficult. The number of branch vessels coming out of the arch is usually mostly three, ie, the left subclavian artery, the left normal carotid artery and the brachiocephalic artery, but some patients have a branch vessel number of 1 There can be two books, more often two, in some cases four, five or even six. Furthermore, the spacing and angular orientation between tributary blood vessels are likely to vary from person to person.

  In order to achieve alignment of the side branch stent or the lateral opening of the main stent with the branch vessel, a custom stent designed and manufactured according to each patient's unique geometric constraints will be required. Measurements required to create a custom-made stent to fit the patient's unique vascular anatomy use spiral tomography, computed tomography (CT), fluoroscopy, or other vascular imaging systems Will be able to get. However, although such measurements and associated manufacturing of such custom stents can be achieved, it will be time consuming and expensive. Furthermore, such a custom stent is not practical for patients who require immediate treatment, including the use of a stent. In these situations, it would be highly desirable to have a stent that can be adjusted in situ as it is deployed. Similarly, it would be highly desirable to have a sufficient degree of adjustment to allow for the number of individual stents that are pre-manufactured and available to meet the required range of sizes and shapes encountered. .

  Another disadvantage of conventional stents and stent-grafts is that once it is placed, adjustment of the position of the stent or stent-graft or subsequent retrieval is limited. During placement of the stent, the final position of the delivered stent is often not optimal for achieving the desired therapeutic effect. During deployment of self-expanding stents, the mode of deployment is to push the stent out of the delivery catheter or, more generally, to retract the outer sheath while holding the stent in a fixed position relative to the vasculature. In either case, the distal end of the stent is not connected to the catheter and can therefore be freely expanded to its maximum diameter and sealed by the surrounding arterial wall. This self-expanding capability is advantageous for deploying the stent, but is detrimental to the user if it is desired to remove or reposition the stent. Some designs utilize the trigger wire to selectively hold the distal end of the stent until the time when sufficient placement is desired and achieved by releasing the “trigger” wire or tether wire. The limitation of this design is the lack of the ability to reduce the overall diameter of the stent by stretching the stent whose distal end is recessed by the trigger wire. It is important to reduce the diameter of the stent while positioning and to determine if it should be released from the tether wire, even when the distal end is retained from the opening by the tether wire, enough to expand the stent. The main body is blocked.

  Another disadvantage of conventional stent grafts is the temporary blockage of blood flow through the blood vessels. In the case of balloon-placeable stents and stent-grafts, inflating the balloon itself while placing the stent or stent-graft causes inhibition of blood flow through the blood vessel. In addition, in certain applications, a separate balloon is used at a distal location on the distal end of the stent delivery catheter to actively block blood flow while the stent is in place. In the case of self-expanding stent-grafts, misplacement of the stent-graft may be due to blockage of arterial flow during placement, requiring additional stent-graft placement in an overlapping manner to complete vascular repair. To do. Even without blood flow obstruction, the strong repulsive force of arterial blood flow can cause the partially open stent-graft to flow downstream due to the high-pressure pulsatile impact force of blood flowing into the partially placed stent-graft. Can be swept away.

  Attempts have been made to address some of the above disadvantages with conventional stents and stent-grafts. For example, US Pat. No. 6,099,548 discloses the use of a string that passes through and is connected to the distal end of a stent that is inserted through a first opening in the vasculature. The string ends are then pulled through a second opening in the vasculature so that the stent can be moved into the vasculature. Although the use of a connecting string provides some additional control in stent placement, those skilled in the art will recognize that passing the string from within the vasculature through the second opening is difficult to operate. it can. In addition, minimizing the number of surgical openings is beneficial to patient welfare when performing any technique.

  Current stent-grafts and stent-graft placement technologies are limited, so they can be used to implant stents or grafts and treat vascular diseases and conditions that affect interconnected blood vessels (ie, vascular trees) There is clearly a need to improve the means and methods to address the shortcomings of the prior art.

  The present invention relates to a vascular graft and a method for producing the same. Implantable devices include, but are not limited to, stents, grafts, and stent-grafts. The device can include a biomaterial such as an extracellular matrix that is coated or connected to at least a portion of the device. The device may consist of a single wire mesh for forming at least a main lumen having a proximal end and a distal end. In many embodiments, the device includes one or more side branch lumens interconnected with the main lumen.

  In one embodiment, a coated implantable adjustment stent is provided having at least 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 along the entire length of the main lumen relative to the proximal and distal ends and can be adjusted with respect to the angle intersecting the main lumen. The stent has a first or unreduced dimension "X" and a reduced dimension "Y" anywhere from less than half of the first dimension "X" to less than one tenth. It is comprised from the superelastic wire which has. For arterial applications where the dimension is the diameter of the stent, the reduced diameter is more likely to approach a tenth of the non-reduced diameter. The smaller the vessel to which the stent is to be implanted, the smaller the required diameter reduction.

  The coated implantable stent of the present invention can be loaded into the tubular opening of the catheter. The catheter can be inserted inside the blood vessel and placed at the appropriate site where the stent can be placed. When deployed, the position of the stent can be adjusted by a plurality of strings removably connected to the stent. Once installed, the stent coating of extracellular matrix material assists in the incorporation of the stent into the vessel wall. The stent, when inside the catheter, is in a reduced configuration and expands and applies pressure within the vessel, thereby opening the vessel channel. Incorporating a stent into a blood vessel using an extracellular matrix reduces problems due to rejection and the appearance of new occlusions.

  The implantable device of the present invention includes at least one lumen having a proximal end and a distal end, but includes at least one side branch lumen to handle an implant site having interconnected blood vessels. There are many. In particular, stents, grafts, and stent-graft form devices are made from interconnected cells that can be selectively manipulated to adjust the length and diameter of the main and side branch lumens of the device. Thus, features of the present invention can handle inconsistencies in the anatomy of serpentine vessels, or variations from patient to patient, such as variations in spacing or angular orientation between tributary vessels in the aortic arch. Provided are adaptable or adjustable stents, grafts or stent-grafts that can be adapted.

  The system of the present invention is particularly suitable for the delivery and placement of a main stent, graft or stent-graft device, particularly within a body vessel or serpentine structure where the implant site includes two or more interconnected vessels. In general, the delivery and placement system of the present invention utilizes at least one elongate member or string, and in many embodiments, utilizes a plurality of elongate members releasably connected to the luminal end of the implantable device. . A string or set of connection strings is provided at each of the proximal and distal ends of the main lumen of the device, and an additional string or set of strings is provided at each side branch lumen. The system can selectively place the device by releasing the tension on the connection string by including means for selectively tensioning one or more of each connection string. The delivery system adjusts the spacing between the various lumens and the adjustment of the respective angular radial orientation relative to the main lumen that changes during in situ placement of the implant at the target location. In addition to the use of releasable strings, there can be other means equally suitable for selective placement of the stent. For example, current can be used for electrolytic erosion of stent end attachment points, similar to the use of removable coils used for aneurysm repair. In other words, the implantable device can be partially deployed, and the entire device is exposed or partially exposed from a delivery system that is most commonly in the form of a nested catheter and lumen assembly. . Each luminal end of the implantable device can be individually positioned as desired, and some or all of the luminal ends can be positioned simultaneously or used sequentially in an order that best facilitates the implantation operation.

  In one embodiment, the implant delivery and placement system includes a series of guidewires, a distal catheter portion and a proximal handle portion that are loaded into the catheter portion prior to delivery to the target site. At least the catheter portion of the system passes over one or more guidewires that direct and position the stent or stent-graft and its respective branches within each target vessel selected for implantation. Various controls are provided for selective tension adjustment and release of the luminal end of the implant, which can be placed on the handle portion, the catheter portion or both. In a preferred embodiment, the catheter portion and / or delivery guidewire can be articulated at the distal end to facilitate navigation through the vasculature.

  One embodiment of the system includes an articulating delivery guidewire or guiding catheter. The articulating guidewire has one or more articulating contacts that allow the operator to change the shape of the distal portion of the guidewire by manipulating the proximal portion of the guidewire. The guide wire can be pre-set and varied from a linear shape to a range of various pre-selected shapes that can be achieved by controlling the individual contact points during manipulation of the proximal portion of the guide wire. In this way, the guidewire can be manufactured to a unique standard for accessing different areas of the vasculature. For example, this can be particularly important in placing an implant in an area that requires an “S” -like path from the entrance to the implant target site. The introduction of a guide wire through the femoral artery access point leading to the implant target in the brachiocephalic artery shows an example of a difficult to anticipate "S" shaped navigation path where such articulated guide wires may be advantageous. ing.

  The methods of the present invention include deploying an implantable device, some of which include the use of a subject system. A method of manufacturing an implantable device is also provided.

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

  Another object of the present invention is to provide a stent deployment method using a guidewire and associated delivery system that enters the vasculature from a single access location.

  An advantage of the stent delivery system of the present invention is that it does not require the use of a space occupancy probe and a balloon catheter.

  Another advantage of the subject system is that it allows position or positioning adjustments and removal during and after stent placement.

  A user with the ability to deploy a stent can evaluate the suitability of the resulting placement using standard images, such as by radiostaining and fluoroscopy or any other imaging system, Check for leaks between the surrounding arterial walls and remove the stent from the delivery system during proper stent placement, or reposition the stent to a new location and repeat in case of improper placement It is a further advantage of the present invention to provide satisfactory results by controlling the delivery and removal of the stent in a manner or to completely remove the stent.

  When a side branch lumen is placed in a branch vessel, the main lumen integrates the cells of the side branch lumen with the cells of the main lumen so that movement is constrained by a “lock and key” mechanism Thus, it is a further advantage of the present invention to secure the stent against movement within the vasculature. More specifically, to the main lumen of the side branch lumen by forming a side branch lumen and a main lumen from the same single wire using a specific wire wrap pattern to form a coupling mesh. An interconnection is achieved that integrates the side branch lumen with the main lumen. Thus, if the side branch is placed in the side branch artery and properly held, the stent body cannot move. In addition, as opposed to active anchoring means such as feathers or hooks, which can damage the cellular structure of the implant site and result in smooth muscle proliferation, restenosis, and other vascular complications. A “passive” mooring mechanism is atraumatic.

  What has been described above with reference to the present invention, and other objects, advantages, and features will become apparent to those skilled in the art upon reading the following details.

  Before describing the devices, systems and methods of the present invention, it is to be understood that the present invention is not limited to the specific therapeutic applications and implant sites described and can vary. Also, since the scope of the present invention is limited only by the appended claims, the terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting. Should be understood.

  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. It should be understood that the terms “proximal” and “distal” when used to refer to the delivery and placement system of the present invention indicate a relative position or location to the user, Refers to a location or location that is closer to the user, and distal refers to a location or location that is further away from the user. When used in connection with the implantable device of the present invention, these terms are understood to indicate a position or location relative to the delivery and placement system when the implantable device is operatively positioned within the system. Should. Thus, proximal refers to a location or location that is closer to the proximal end of the delivery and placement system, and distal refers to a location or location that is closer to the distal end of the delivery and placement system. The term “implant” or “implantable device” as used herein includes, but is not limited to, devices comprising stents, grafts, stent-grafts and the like.

  As used in this specification and the appended claims, the singular forms “a”, “an” and “the” include plural referents unless the context clearly dictates otherwise. . Thus, for example, reference to “a string” can include a plurality of such strings, and a reference to “the tubular member” includes one or more tubular members and their equivalents known to those skilled in the art, etc. Including the reference.

  Where a range of values is provided, unless the context clearly indicates otherwise, each intervening value will naturally fall between the upper limit and the lower limit of that value to a tenth of the lower limit unit. Disclosed. Each stated value or intervening value within the stated range and each other smaller range of any stated or intervening value within that stated range is encompassed within the invention. Is done. The upper and lower limits of these smaller ranges may be independently included or excluded within the range, which boundary includes or does not include either boundary, or Each range that includes both limits is also included in the present invention and is subject to any specifically excluded boundary in the described range. Where the stated range includes one or both of the boundaries, 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 for the purposes of disclosing and describing the methods and / or materials associated with the cited publication. The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. The present invention should not be construed as an admission that such publication is not entitled to antedate by virtue of prior invention. Further, the dates of publication provided may be different from the actual publication dates and may need to be independently verified. The invention will now be described in greater detail in the following description of exemplary embodiments of the invention and various devices, systems and methods. The present invention generally includes an implantable device comprising a tubular member in the form of a stent, graft or stent-graft, the device comprising one or more segments extending laterally from the main or basic tubular member. A branch or cross tubular member may further be included. The invention further includes a system for percutaneous, intravascular delivery and placement of a device implantable at a target implant site in the body. The implant site can be any tubular or hollow tissue lumen or organ; however, the most typical implant sites are vasculature structures, particularly the aorta. A feature of the present invention is to deal with applications involving two or more intersecting tubular structures and is therefore particularly suitable in situations where vascular trees such as the aortic arch and the lower renal aorta are treated.

Implantable Device of the Invention Referring now specifically to the drawings and FIGS. 1A and 1B, there is shown an exemplary embodiment of the implantable device of the invention. Although each of the devices has a basic or main tubular member and at least one laterally extending tubular branch, the implantable devices of the present invention need not have side branches.

  FIG. 1A shows a laterally extending side branch 6a, 6b and 6c having a basic tubular portion, body or member 4 and interconnected with a main body 4 by a lateral opening in the body and in fluid communication. Fig. 2 shows a variation of the implantable device 2 comprising. The proximal and distal ends of the main tubular member 4 end with a crown or apex 8, the number of which can vary. The distal ends of the side branches 6a, 6b and 6c terminate in crowns or apex 10a, 10b and 10c, respectively, and the number can also vary. The device 2 is specifically configured for implantation in the aortic arch, the basic tubular member 4 being positionable within the arch wall, and the tubular branches 6a, 6b and 6c are respectively the brachiocephalic anonymous artery, usually the In the left carotid artery and left subclavian artery.

  As will be described in greater detail below, the placement or connecting member of the main delivery and placement system is via apex 10a, 10b and 10c extending from the distal end of the apex of device 2, or an eyelet (shown). Not) will be looped through. The connecting members of the present invention can be any extension, including but not limited to any string, filament, wire, stranded wire, tubule or other elongate member that can be releasably connected to the distal ends of the various lumens of the stent. It can be a member. The means of releasable connection includes, but is not limited to, electrolytic erosion, thermal energy, magnetic means, chemical means, mechanical means or any other controllable detachment means.

  FIG. 1B shows another variation of device 12 having a basic tubular portion, member 14, interconnected with body 14 and in fluid communication by a lateral opening in the body. The proximal and distal ends of the main tubular member 14 terminate in a crown or apex 18 used as described above with respect to FIG. 1A, while the distal ends of the side branches 16a and 16b are crown or apex 28a, respectively. And 18b. The device 12 is specifically configured for implantation of the subrenal aorta, the basic tubular member 14 can be placed in the aortic wall, and the tubular branches 16a and 16b are placed in the left and right renal arteries, respectively. .

  The main implant can have any number of lumen structures (eg, one main lumen without side branch lumens, a main lumen and one or more side branch lumens), one or The multiple side branch lumens can be placed at any suitable position along the entire length of the main lumen at any angle with respect to the major axis of the main lumen, and when there are two or more side branch lumens, Those skilled in the art will recognize that the lumens can be bent and spaced apart at an angle that is axially parallel and circumferential with respect to each other to accommodate the target vasculature in which the implant is placed. . Furthermore, the length, diameter and shape (eg, radius of curvature) of each of the implant lumens can vary as it needs to be adaptable to the vessel being deployed. The main lumen typically has an unconstrained length ranging from about 1 cm to about 25 cm and an unconstrained diameter ranging from about 2 mm to about 42 mm. The side branch lumen typically has an unconstrained length in the range of about 0.5 cm to about 6 cm and an unconstrained diameter in the range of about 2 mm to about 12 mm. For example, for aortic applications, the unconstrained length of the main lumen is typically from about 8 cm to about 25 cm, and the unconstrained diameter ranges from about 15 mm to about 42 mm; the side branch lumen is about It has an unconstrained length ranging from 2 cm to about 6 cm and an unconstrained diameter ranging from about 5 mm to about 12 mm. For renal applications, the main branch lumen has an unconstrained length in the range of about 2 cm to about 5 cm, and an unconstrained diameter in the range of about 3 mm to about 9 mm; It has an unconstrained length in the range from 5 cm to about 3 cm and an unconstrained diameter in the range from about 2 mm to about 7 mm. For coronary applications, the main branch lumen has an unconstrained length in the range of about 1 cm to about 3 cm and an unconstrained diameter of about 2.0 mm to about 5 mm; the side branch lumen is about 0 It has an unconstrained length in the range from 5 cm to about 3 cm and an unconstrained diameter in the range from about 2 mm to about 5 mm. Of course, for smaller blood vessel applications such as the neurovascular system, these dimensions are smaller. Various structural and functional aspects of the implants of the present invention are discussed in greater detail below.

  It is also contemplated that a therapeutic or diagnostic component or device can be integrated with the primary implant. Such devices include, but are not limited to, prosthetic valves such as heart valves (eg, aortic or pulmonary valves) and venous valves, sensors that measure flow, pressure, oxygen concentration, glucose concentration, etc., electrical pacing leads And so on. For example, as shown in FIG. 1E, an implant 210 for treating the aortic root is provided that includes a mechanical or biological prosthetic valve 216 used at the distal end of the main lumen 212. In addition, device 210 includes two smaller, generally opposite side branch lumens 214a and 214b, each adjustably aligned within the left and right coronary ostium. The length of the stent-graft can be selected to extend to a selected distance that ends at any location before, within, or after the aortic arch, for example, it can extend into the descending aorta. Any number of side branches can be provided to accommodate branch vessels of the aortic arch.

  Any suitable stent or graft structure includes, but is not limited to, the aorta-ileum artery bifurcation, femoral-popiteal bifurcation, short head artery, posterior spinal artery, coronary artery bifurcation, carotid artery, upper and lower mesenteric artery To handle other applications at or near other intersections of two or more blood vessels (eg, bifurcation, trifurcation, quadrifurcation, etc.), such as whole gastrointestinal artery, cranial artery and neurovascular bifurcation One skilled in the art will recognize that it can be provided.

  As noted above, the implantable devices of the present invention can include a stent or graft, or a combination of the two, referred to as a stent graft, a stented graft, or a grafted stent. The stents and grafts of the present invention can be made from any suitable material known in the art. Although any suitable material can be substituted, the stent is preferably composed of wire. The wire stent needs to be elastically adaptable, for example, the stent can be made from stainless steel, elgiloy, tungsten, platinum or nitinol, but any other suitable material can be used: It can be used in place of or in addition to these commonly used materials.

  The stent can have any suitable wire form pattern or can be cut from tubing or flat sheets. In one embodiment, the entire stent structure is fabricated from a single wire mesh into an interconnected cell formation pattern, for example, a closed bonded structure. The structure has a linear cylindrical shape, a curved tubular shape, a tapered hollow shape, and an asymmetric cell size, for example, the cell size can vary along the entire length of the stent or near the circumference. In certain stent embodiments, the side branch lumen cell size gradually decreases in the distal direction. In addition, this helps the ability to selectively extend the most distal portion of the side branch lumen, thus facilitating the physician to guide the distal end of the side branch to the designated vessel. The distal end of the main stent lumen and / or the distal end of one or more side branch stent lumens can be expanded in a trumpet shape. The struts of the stent (ie, the basic part that forms the cell) can vary in diameter (in the wire embodiment) or thickness or width (in the sheet and tube cutting embodiment).

  In one particular embodiment, the stent is composed of a single wire. The selective weaving and knitting of the connection points along the length of the stent allows the angle of the side branch stents to each other and to the main stent lumen within a selected range that can accommodate any possible changes in the treated anatomy In terms of orientation, a single wire stent shape that provides adjustability is advantageous. Such angular orientation of the side branch lumen can be axial, circumferential, or both. FIG. 1C shows the implant device 20 wherein each of the side branch lumens 24 and 26 has an angular orientation defined by an angle α with respect to the main lumen 22 and an angle defined by an angle β relative to each other. Has directionality. FIG. 1D is an end view of the implant device 20 showing the circumferential orientation defined by the angle θ between the side branches 22 and 24. Typical ranges for the various angles are as follows: from about 10 ° to about 170 ° for angle α, from 0 ° to about 170 ° for angle β, and from 0 ° to 360 ° for angle θ. These orientations can be provided by a fabrication method that results in a stent having an orientation that is naturally biased in unconstrained, pre-positioned conditions, ie, a neutral state. One or more of these orientations can be selectively adjusted within the range of angles provided above during delivery and placement of the branch lumen within the respective vessel lumen. This design also allows the linear spacing between the side branch stems to be adjusted by extending and / or shortening the main lumen of the stent. In addition, the side branch portion can be stretched to allow placement of a large stent in a smaller branch vessel, thereby providing proper attachment between the stent and the vessel wall. It should be noted that the adjustability of the stent does not impair the radial force necessary to prevent fixation and anchoring of the stent and / or stent-graft and migration and endoleak.

  The graft portion of the stent-graft can be made from a woven fabric, polymer, latex, silicone latex, polytetrafluoroethylene, polyethylene, dacron polyester, polyurethane or other suitable material such as biological tissue. Biological tissues that can be used include, but are not limited to, extracellular matrices (ECMs), acellular uterine walls, decellularized cavity lining or membranes, acellular urethra membranes, umbilical cord tissue and collagen Is mentioned. Suitable extracellular matrices for use in accordance with the present invention include liver basement membranes derived from mammalian gut, stomach, urinary bladder submucosa, dermis or sheep, cows, pigs or any suitable mammal. The graft material must be flexible and durable to withstand the mounting action and use. Those skilled in the art will recognize that the subject invention implants can be formed by many different well-known methods, such as by being knitted or formed by immersing the substrate in the desired material. .

  Warm-blooded vertebrate submucosal tissues (ECMs) are useful for tissue transplant materials. For example, small intestinal derived submucosal tissue transplant compositions are described in US Pat. No. 4,902,508 (hereinafter the '508 patent) and US Pat. No. 4,956,178 (hereinafter the' 178 patent). A submucosal tissue transplant composition derived from the bladder is described in US Pat. No. 5,554,389 (hereinafter the '389 patent). All of these (ECMs) constructs are generally constructed from 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 method detailed in the '508 patent, incorporated by reference in the methods detailed in the' 389 and '178 patents, is disclosed in at least the luminal portion of the intestinal or bladder mucosa, ie, in the' 178 patent. A mechanical abrasion step is included to remove tissue linings, such as epithelial mucosa (epithelium) and lamina propria as detailed. Mucosal abrasion, detachment, or scraping causes the epithelial cells and their associated basement membranes, most of the lamina propria, to delaminate at least to the level of the organic dense connective tissue, the dense layer. Thus, tissue transplant materials (ECMs) previously recognized as soft tissue replacement materials lack the epithelial basement membrane and consist of submucosa and dense layers.

  (ECMs) Epithelial basement membranes can be in the form of a thin sheet of extracellular material adjacent to the basal plane of epithelial cells. Sheets of similar types of aggregated epithelial cells form the epithelium. Epithelial cells and associated epithelial basement membranes are located in the luminal part of the mucosa and constitute the inner surface of the body's tubular and hollow organs and tissues. Epithelial cells and associated epithelial basement membranes are also placed on the outer surface of the body, ie the skin. Examples of typical epithelium with a basement curtain include, but are not limited to: skin, intestine, bladder, esophagus, stomach, cornea and liver epithelium.

  Epithelial cells are placed in the lumen or surface side of the epithelial basement membrane facing the connective tissue. For example, the connective tissue and submucosa are disposed away from the lumen of the basement membrane or on the deep side. Examples of connective tissue used to form ECMs that are placed on the side of the epithelial basement membrane away from the lumen are the submucosa of the intestine and bladder, the dermis and subcutaneous tissue of the skin. All of these materials are referred to herein as ECMs or extracellular matrix materials and can be used to coat all or any portion of the stent.

  The stent can be coated or mechanically anchored to the implant, for example, by physical or mechanical means (eg, screws such as sutures or staples, cement, fasteners) or friction. In addition, mechanical connection means can be used to effect the connection to the implant site by including a means for anchoring to surrounding tissue in the stent design. For example, in order to properly hold the stent, the device may include metal spikes, anchors, hooks, wings, pins, clamps, or flanges or lips.

  Stents may be processed in such a way that a coating made of ECM material or the like adheres only to the wire and does not stretch between wire segments or within stent cells. For example, energy can be applied in the form of a laser beam, current or heat to the wire stent structure while the ECM is in contact with the substructure. The ECM could be applied to the stent in this manner just like cooking meat on a hot pan leaves tissue.

  The main stent, graft and / or stent graft can be coated to provide local delivery of the therapeutic agent or drug to the disease site. Compared to systemic administration, which requires frequent administration and loses material before reaching the target disease site, local delivery requires less dose of therapeutic agent or drug delivered to the concentrated area.

  The submucosa may have a thickness of about 80 micrometers and consists mainly of extracellular matrix material (> 98%) eosinophilic staining of cells (H & E staining). Spindle cells consistent with transient blood vessels and fibroblasts can be randomly distributed throughout the tissue. Typically, UBS is washed with saline and optionally stored in a frozen hydrated state until use.

  Fluidized UBS is in a manner similar to the preparation of fluidized intestinal submucosa, as described in US Pat. No. 5,275,826, the disclosure of which is expressly incorporated herein by reference. Can be prepared. UBS is crushed by tearing, cutting, crushing, shearing, and the like. Although grinding of UBS in the frozen or lyophilized state is preferred, the suspension of submucosal tissue pieces can be subjected to high speed (high shear) mixer processing and dehydration treatment, if necessary, by centrifugation and decanting of excess water. By providing, better results can be obtained. In addition, enzymatic digestion of the bladder submucosa with a pulverized fluidized tissue, a time sufficient to solubilize the tissue and form a substantially homogeneous solution, a protease such as trypsin or pepsin, or other suitable enzyme Can be solubilized.

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

  The main stent, graft and / or stent graft are coated by applying a primer layer to the surface. The primer layer forms a reservoir containing the therapeutic / agent. The overlap area between the primer layer and the active ingredient can be modified to increase the permeability of the primer layer to the active ingredient. For example, by applying a normal solvent, the active ingredient and the surface layer are mixed together and the active ingredient is absorbed into the subbing layer. Furthermore, the primer layer can also be treated to produce a non-uniform or rough surface. This coarse area takes up the active ingredient and increases the diffusion of the ingredient when the stent is inserted into the patient. As such, the implant has the ability to diffuse drugs or other agents at a controllable rate. Further, those skilled in the art will appreciate that the present invention can provide a combination of multiple coatings, such as the subbing layer being divided into multiple regions each containing a different active ingredient.

  Main stents, grafts and / or stent grafts include, but are not limited to, dexamethasone, tocopherol, dexamethasone phosphate, aspirin, heparin, coumadin, urokinase, streptokinase and TPA, or thrombus formation at the implant site It can be coated with any therapeutic substance, composition or drug, such as any other thrombolytic substance suitable. In addition, therapeutic agents and pharmacologically active agents include, but are not limited to, submucosal tissue stabilization to increase proteolytic resistance as a means to prevent post-transplant aneurysm development in decellularized natural vascular scaffolds Tannic acid mimetic dendrimer, cell adhesion peptide, collagen mimetic peptide, hepatocyte growth factor, growth / antimitotic agent, paclitaxel, epidipodophyllotoxin, antibiotics, anthracycline, mitoxan Throne, bleomycin, plicamycin, and mitomycin, enzyme, antiplatelet agent, non-steroidal agent, heteroaryl acetic acid, gold compound, immunosuppressant, angiogenic agent, nitric oxide donor, antisense oligonucleotide, cell cycle inhibitor, And protease inhibitors.

  The subject implant can also be seeded with any cell type, including stem cells, to promote angiogenesis between the implant and the arterial wall. Included is a method of applying a porous coating to a device that allows tissue growth into a gap in the implant surface. Other efforts to improve host tissue proliferative capacity and adhesion of implants to host tissue cells involve the inclusion of charged or ionic materials on the tissue contacting surface of the device. As noted above, the main stents and grafts can also be provided with a coating, or implanted or embedded with an extracellular matrix (ECM) material, or completely from the extracellular matrix material. Can be produced. Suitable ECM materials are derived from mammalian host sources and include, 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, but are not limited to, collagens such as fibronectin, fibrin, fibrinogen, fibrillar and non-fibrillar collagen, adhesive glycoproteins, proteoglycans, hyaluronan, acidic and cysteine-rich secreted proteins (SPARC) ), Thrombospondin, tenascin, and cell adhesion molecules, and matrix metalloproteinase inhibitors.

  The ECM portion of the implant is finally resorbed by the tissue to which it is resorbed, for example, surrounding tissues that exhibit epithelial, smooth muscle, and outer membrane properties. Even so, an ECM scaffold having a selected shape can be operatively connected to a stent or stent-graft of the present invention at a selected location, thereby allowing the ECM material to a natural tissue structure at the selected location. Continue to undergo remodeling. For example, an ECM scaffold can be constructed in a manner that creates the structural characteristics of the arterial leaflet and can be placed in the form of a natural arterial valve that has been previously removed, whereby the implant provides the valve function.

  The stents, grafts, or stent-grafts of the present invention can also have pressure, flow rate, rate, turbidity, and other physiological parameters, as well as, for example, glucose concentration, pH, sugar, blood oxygen, glucose, moisture, One or more sensors can be included to monitor concentrations of chemical species such as radioactive substances, chemicals, ions, enzymes, and oxygen. The sensor should be designed to minimize the risk of thrombus formation and embolization. Therefore, blood flow slowing or stopping must be minimized at any point within the lumen. The sensor may be directly connected to the outer surface, contained within a packet, or secured within the stent, graft, or stent-graft material of the present invention. In addition, the biosensor can use wireless means to deliver information from the implantation site to a device outside the body.

  The stent, graft, or stent-graft can be made from a visualization material or include a marking element that provides an indication of device orientation to facilitate proper alignment of the stent at the implant site Can be configured. Suitable materials that can impart radiopacity include, but are not limited to, metals such as barium sulfate, bismuth trioxide, iodine, titanium oxide, zirconium oxide, gold, platinum, silver, tantalum, niobium, stainless steel, and the like Combinations of these can be used. The entire stent or any portion thereof can be made from or labeled with a radiopaque material, ie, the top of the stent.

Device Fabrication Methods The stent of the present invention can be fabricated in a number of ways. One method of making a stent is by the use of mandrel devices such as mandrel devices 320, 330, and 340 shown in FIGS. 13A-13C, respectively. Each device selectively places a plurality of pins (not shown) therein or extends a plurality of pins therefrom, respectively, and a plurality of selectively placed pinholes 324, 334 and 344, respectively. Each having at least one primary mandrel component 322, 332 and 342. As described in more detail below, the stent structure is formed by selectively winding a wire around a pin. If the stent will have one or more side branch lumens, a mandrel device, such as device 340, may comprise at least one side mandrel 346 that extends substantially transverse to the main mandrel 342. The number of lateral mandrels preferably corresponds to the number of stent side branches formed. The mandrel device can be a modular that allows side branch mandrels of varying diameter and length to be removably assembled to the main mandrel. To form the desired stent shape, the shape of the main mandrel as well as the side branch mandrel can have any suitable shape, size, and diameter. Typically, the mandrel component has a linear cylindrical shape (see FIGS. 13A and 13C) with a uniform cross-section, but can also be a conical shape (see FIG. 13B) with varying diameter along the length dimension, a trapezoidal cone May have an elliptical cross section, a curved shape, and the like.

  The pins can be permanently affixed to the mandrel component or can themselves be removed from and removed from holes formed in the mandrel component and selectively disposed within the holes. Further, the mandrel device can be configured to selectively extend and retract the pins. The number of pins and the distance and spacing between them can be varied to provide a set pin shape. This setting allows the fabrication of stents with variable sizes, lengths, cell sizes, etc., using a limited number of mandrel components. For example, in one variation, the pins are arranged around the mandrel component in an alternating pattern, for example, placing the pins into four of the eight pinholes per row. Alternatively, a selection of mandrels can be provided, each having a unique pinhole pattern that in turn defines a unique stent cell pattern.

  A shape memory wire, such as NITINOL, having a selected length and diameter is provided to form a stent. Typically, the length of the wire ranges from about 9 feet to about 12 feet in length, but can be longer or more practical if necessary. Wire diameters typically range from about 0.001 inch to about 0.020 inch. After providing a mandrel device having a winding pin at a desired point or location on the mandrel component, the wire is wound around the pin in a selected direction and in a selected top and bottom overlapping pattern, for example, a zigzag pattern. To form a series of interconnected wavy rings that produce the desired cell pattern.

  A representative wire winding pattern 350 is shown in FIG. Starting from one end of the main mandrel, the wire 352 is wrapped around the pins 354 in a zigzag pattern back and forth from one end of the main mandrel to the other until cells in the main lumen of the stent are formed. The same wire that is still connected to the mandrel device is then used to form the side branch lumen, which extends distally from the base of the side branch mandrel until all cells in the side branch have been created. Wrapped in a zigzag style to the end that is back and back again. The wire is then wrapped around the main mandrel along a path at an angle to the major axis of the main mandrel, and the wire is doubled on itself along a certain cell segment 356. Become. It should be noted that any lumen of the stent may be fabricated first, followed by others, or a winding pattern in which various lumen portions are formed intermittently. .

  The mandrel device on which the wire stent pattern has been formed is then heated to a temperature in the range of about 480 ° C. to about 520 ° C., typically about 490 ° C. for about 20 minutes, during which time the salt bath is It can be shortened by using. The time required for the heat curing step depends on the time required to shift the wire material from the martensite phase to the austenite phase. The assembly is then air cooled or placed in a water bath and allowed to air dry to quench for more than 30 seconds. When the stent is sufficiently dry, the pin is pulled out of the mandrel device or pulled into the hollow center of the mandrel by manipulating the inner part protruding the pin from the respective hole on the outer surface of the mandrel device. The stent with its interconnecting lumen can then be removed from the mandrel device. Alternatively, the mandrel component can be removed from one another and one of the lumens, eg, the main stent lumen, can be formed first, and then the side mandrel can be connected to the main mandrel, and then the side branch lumen can be formed.

  Optionally, the selected portion of the body or the portion of the wire that forms the side branch lumen cell is selectively sized by etching or electropolishing to exert less radial force than the wire portion of the stent without reducing the wire diameter. Can be reduced. An example of a selective reduction in the stent body wire diameter is to secure the stent without displacement, leaving these regions with a 1 to 2 centimeter perimeter portion at each of the proximal and distal ends. In order to make it easier to stretch the stent during deployment or more easily compress it into the delivery sheath over a longer length The wire diameter in the cross section of the central portion between these high radial force regions can be reduced. Another example of a selective reduction in wire cross-sectional diameter is to make side branch struts of smaller diameter. This can be done by selective immersion in the side branch acid during manufacture to reduce the amount of metal in a particular area of the stent. Another way to achieve the desired result of preferentially reducing the lateral branch longitudinal stiffness and / or the outward radial force of the side branch component material is to use an electropolishing apparatus. The solid metal mesh stent is placed in an electrolytic bath, and metal ions are dissolved in the electrolytic solution by applying a voltage potential across the anode-cathode gap where the stent itself is the anode. Alternatively, the method can subsequently be reversed and the stent becomes the cathode and the side branch or other selected area of the stent changes the mechanical properties or enhances the radiopacity of the selected area. Can be electroplated with similar or different metals such as gold or platinum in an ionic solution. Those skilled in the art of electroplating and electropolishing will recognize that there are techniques that use a “strike” layer of a material similar to the substrate to enhance the bonding of a material different from the substrate. An example would be the use of a pure nickel strike layer on top of a nickel titanium (NITINOL) substrate followed by bonding a gold or platinum coating to the substrate.

  Another method of making a stent is a thin-walled tubular member, such as stainless steel tubing, to remove the tubing portion in the desired pattern of the stent, leaving a relatively unused portion of the metal tubing that will form the stent. Is to cut. Stents can also be made from other metal alloys such as tantalum, nickel-titanium, cobalt-chromium, titanium, shape memory alloys and superelastic alloys, noble metals such as gold or platinum.

  According to the present invention, those skilled in the art use several different methods to make the main stent, including using different types of lasers; chemical etching; electrical discharge machining; laser cutting of flat sheets and rolling into cylinders. Yes; you will know that all these are now well known to the industry.

  If the stent graft 360 can be formed by the addition of an implant material 362, such as an ECM, to the main stent 364, any manner of connecting the implant material to a wire form can be used. In one variation, the implant material is connected by a suturer 366. Thus, one edge edge 370 of the graft material is sewn along the length of the stent frame in the longitudinal direction of the stent frame and at least one knot on each apex of the stent to secure the distal end of the graft to the stent. Tie 368. The graft material is then stretched around the surface of the stent, and the opposite edge 372 of the graft is overlapped with the already connected edge 370 to provide a leak-free surface through which blood cannot flow out, independent of the stent frame. Sew. In order to prevent the stent from drooping when in the expanded state, the graft material is stretched to an extent corresponding to the conformability of the stent. Upon complete connection of the graft material, the graft is dehydrated so that it shrinks tightly onto the stent frame, similar to the heat shrink tubing during heating.

Delivery and Placement System of the Invention Referring now to FIGS. 2A and 2B, the system 30 of the present invention is shown for implanting a device of the present invention. System 30 includes a distal catheter portion 32 and a proximal or handle portion 34. Catheter portion 32 is configured to be placed in a blood vessel or other pathway leading to an implant site and includes various elongated members having multiple lumens, but from one end of the guide wire, pull wire, and device to the other. Many of these are multi-functional with respect to the liquid flow path. Catheter portion 32 includes a translatable outer sheath 38 having a lumen that receives intermediate member 40. The proximal end of the outer sheath 38 is configured with a mounting piece 50 for coupling to the distal hub 52 of the intermediate portion 40. The attachment component 50 is comprised of an internal valve mechanism that fluidly seals the luminal space between the walls of the outer member 38 and the intermediate member 40, thereby preventing leakage of blood therefrom. The fitting 50 further includes a flush port (not shown) for exhausting residual air, usually during catheter preparation. Inner member 42 is translatable received within lumen 138 (see FIG. 6A) of intermediate member 40 and defines a main guidewire lumen 44 for translational movement of guidewire 48 therethrough. Inner member 42 terminates in a conical tip 46 that facilitates forward translation of the device through the serpentine vasculature. The outer member, intermediate member and inner member tubing (and any catheter component discussed below) are, but are not limited to, biocompatible plastic reinforced with braided material or substantially flexible. It can be made from materials used to construct conventional endovascular sheaths and catheters, such as any other biocompatible material.

  Proximal portion 34 of delivery and placement system 30 includes proximal and distal handle portions 36a, 36b that translate axially relative to each other. Inner member 42 is secured to the proximal portion 36a of the handle and intermediate member 40 is secured to the distal portion 36b of the handle so that two correlating to each other, as described in greater detail below. The axial separation and extension of the handle portion adjusts the amount of extension and shortening received by the stent operably loaded into the delivery system.

  As noted above, delivery and placement of the implants of the present invention is accomplished through the use of multiple designed lines, strings, wires or filaments. A string or set or strings is provided for adjustment of each free end of the implant relative to the delivery system and for a releasable connection. Two separate strings or two sets of strings are used to adjust the main tubular portion of the implantable device—one string or one set of strings adjusts the distal end of the device and others The string is for adjusting the proximal end of the device. For each lateral branch of the implant, an additional string or set of strings is provided. The number of strings in each set is equal to the number of parietal points or attachment points provided at each end of the device (ie, at the proximal and distal ends of the main stent portion and at the distal end of the branch portion). Related. Each string is arranged in the handle of the device and is knitted with the apex designated by its ends adjusted, one end of each connection string being permanently fixed to the delivery and placement system 30 and the other end being Releasably connected to the delivery and placement system 30. When operated and loaded into the system 30, the lumen end of the implant is releasably connected to various portions of the system 30. For example, the distal end of the main lumen of the stent is releasably connected to the inner member 42, and the proximal end of the main lumen of the stent is releasably connected to the intermediate member 40, the distal end of each side branch stent. The end is releasably connected to a designated side branch catheter 150 (see FIG. 6A).

  Each connection string or of the connection string is adjusted, that is, it can be fixed, released, pulled, pulled out, tightened, etc. by a specified adjusting mechanism. Alternatively, the number of adjustment mechanisms provided in the illustrated embodiment of the main system corresponds to the number of connected string sets; however, string set adjustments can be integrated into a smaller number of adjustment mechanisms. The various adjustment mechanisms can have any suitable shape and are mounted in any suitable position on the system 30, although one exemplary shape and position of the adjustment mechanism is shown in FIG. 2A. . In particular, each adjustment mechanism includes a pair of adjustment materials in the form of knobs, dials, switches or buttons, for example, one adjustment material arranged for linear translation, i.e. when using an implant. The string is withdrawn by the fixed end via the system 30 and the other adjuster is for selectively releasing and fixing the free end of the string prior to placement of the implant.

  Adjusters 70a, 70b and 72a, 72b for adjusting the distal and proximal luminal ends of the stent, respectively, are provided on the handle portions of 36a and 36b, respectively. A further adjustment pair for each set of connecting strings associated with each of the implant's side branches or side branch lumens is provided on a hub releasably attached to the intermediate member 40, the collective hub comprising an outer sheath 38. Between the proximal end and the distal end of the distal handle portion 36b. For example, for use of the implant 2 of FIG. 1A having three branch lumens 6a, 6b and 6c, three hubs 74, 76 and 78, respectively, and associated adjuster pairs are provided and adjustments 74a, 74b. The most distal pair adjusts the connection string for the most distal stent branch lumen 6a and the second or intermediate pair of adjustments 76a, 76b adjusts the connection string for the intermediate stent branch lumen 6b The proximal pair of adjustments 78a, 78b then adjusts the connection string for the proximal position of the stent branch lumen 6c.

  Each pair of adjusters includes fixed end members 70a, 72a, 74a, 76a and 78a, but the ends of the connection string of one set, fixed set are permanently fixed, but as such, the strings are passed through them. In the form of a knob that can be removed and removed from the respective handle portion or hub for manual withdrawal. This adjustment maintains a constant tension on the connecting string and maintains the constrained implant within the delivery system while the delivery system is coupled through the vasculature. As best shown in FIG. 2B, each knob is positioned within a hemostasis valve 80 to prevent backflow of liquid, eg, blood from the handle or hub, before and after the knob is removed from the handle or hub. . Each pair of adjusters also includes a releasable end member or clamp 70b, 72b, 74b, 76b or 78b, where they are releasable with the free end of the string set at the respective handle portion or hub It is in the form of a dial or a drive screw that is fixed to. When ready for placement of each lumen end of the implant, the drive screw is selectively loosened to allow tension release on each string set. Those skilled in the art will recognize that the relevant arrangement and arrangement of the various regulatory mechanisms can vary in order to provide an organized, biotechnologically designed shape.

  Referring now to FIGS. 2B, 3A, and 3B, each of the side branch adjustment hubs 74, 76, and 78 is associated with a distally placed side branch catheter hub 84, 86, and 88, respectively (most proximally located). Only the hubs 78 and 88 are illustrated in FIG. 2B). Extensions between each pair of hubs are proximal portions 94a, 94b, 94c of side branch catheters 150a, 150b, 150c (see FIG. 6A), respectively, and can be sealed behind each adjustment hub 74, 76, 78. Extending from the ports 110a, 110b, 110c (see FIG. 2B) through respective side branch catheter lumens 148 (see FIG. 6A) in the intermediate member 40 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 entry and passage of side branch guidewires 154a, 154b, 154c (see FIG. 6A) through respective side branch guidewire lumens 152. One or both of the side branch catheter and the side branch guidewire is bendable. Each of the adjustment hubs 74, 76 and 78 is slidably engaged by the intermediate member 40. The bottom surface of the adjustment hub has a cuff 96, a partial ring shape, etc. so that the hub can be fully released from the intermediate member 40 as well as the slidable top thereof. As described above, each of the side branch stent lumens is releasably coupled to the distal end of side branch catheters 150a, 150b, 150c by a designated connection string or set of connection strings. Regardless of the associated position between the side branch adjustment hubs 74, 76, 78 and the associated side branch catheter hubs 84, 86, 88, the connection string set is released until it is released by the respective adjustment knobs 74b, 76b, and 78b. They are held at full tension in both shapes illustrated in FIGS. 3A and 3B. As illustrated in FIGS. 2A and 3B, when the adjustment hub is in a distal or proximal position with respect to the catheter hub, the proximal portions 94a, 94b, 94c of the side branch catheters 150a, 150b, 150c are within the associated catheter hub. And the side branch stent is held in a partially deployed state. In the partially deployed state, the side branch stent is removably connected to the distal end of the apex or connection point of the extended side branch stent by the respective string or string set of side branch catheters. It is stretched and held by the tension applied by the distal ends of the side branch catheters 94a, 94b, 94c. The tension applied to the distal end of each side branch stent travels through the side branch stent, thereby extending its length while simultaneously reducing the diameter. This allows positioning of a larger stent diameter within a smaller diameter side branch vessel. This partially deployed state, i.e., the diameter of the side branch stent is smaller than the deployed side branch vessel, allows blood flow around the implant and thereby allows perfusion of downstream vessels and organs during placement. enable. In order to avoid achieved ischemia for downstream organs, priority is given to keeping the blood flowing by crossing the side branch vessels during this technique. The side branch stent is stretched by extension of a side branch catheter that is releasably connected to the top of the distal end of the side branch stent. The extension of the side branch stent allows subsequent placement within the undersized target side branch vessel. Typically, the diameter of the side branch stent in the natural unconstrained state is about 5% to about 50% larger than the diameter of the side branch vessel to be deployed. Conversely, as illustrated in FIGS. 2B and 3A, when the adjustment hub is in the proximal or retracted position, each side branch stent is held under deployed or non-stretched conditions.

  Side branch catheters 150a, 150b, 150c are slid and extended at proximal ends 94a, 94b, 94c by respective side branch catheter hubs 84, 86, 88 and hemostasis valves 92a, 92b, 92c located at the rear ends of the catheter hubs. To do. Each side branch adjustment hub 74, 76, 78 has a luer fitting 110a, 110b, 110c (only 110c is shown) that allows an applied hemostasis valve (not shown). The hemostasis valve can be a Y-arm adapter or a Toughy-Borst adapter that allows a sealed introduction of the guidewire. The Y-arm luer fitting can remove guidewire air by flushing the catheter with saline prior to inserting the catheter into the body. In the next step of the method, the lumen can be used to introduce radiographic dye to visualize blood flow through the side branch artery.

  As illustrated in FIG. 4, a main body port 76 located at the rear end of the proximal handle portion 36a extends through a central lumen 138 (see FIGS. 6A and 6B) in the intermediate member 40. In fluid communication with cavity 44. A guidewire lumen 44 directs and guides the distal portion 32 of the system to a target implant site within the vasculature and facilitates positioning and implantation of the distal end of the main lumen of the implantable device. Provides the passage and translation of the main guidewire 48 used in The main port 76 has a luer fitting similar to the luer fitting 110 described above with respect to the side branch catheter adjustment hub.

  As further illustrated in FIG. 4, a lever mechanism 56 extending distally and downwardly from the proximal handle portion 36a provides for steering of the distal catheter portion 32 of the device 30 through the deployed vasculature. This lever can be replaced by rotating the adjustment knob 193 of another handle embodiment 194 shown in FIG. 9A. A steering pull wire, string or filament (not shown) is secured to the proximal end of the lever 56 and terminates through its distal end and extends through the catheter portion 32 connected within the north cone 46 of the inner member 42. To do. The lever 56 is coupled to the center in the handle portion 36a so that when it is rotated in a downward direction (indicated by arrow 65a in FIG. 4), the steering pull wire is relaxed or loosened. Conversely, if the lever 56 is rotated upward (indicated by arrow 65b), the distal tip of the inner member 42 and thus the distal end of the device 30 is bent by pulling or pulling the steering pull wire. Let Any number of steering pull wires can be used and selectively pulled to selectively articulate the distal end of multidirectional device 30 perpendicular to the long axis of the implantation system. Typically, the main delivery and placement system has at least one, often two to four distal linkage contacts. These points can be at one or more distances from the distal end of the catheter 32 to create a compound curve at the distal end of the catheter.

  5A-6C, 6A and 6B will now be described with respect to the relative positioning and connection of an implantable device having various catheters, lumens, guide wires, ports and pull wires of the main implantation system. FIGS. 5A-5C illustrate an implantable device 120 partially disposed from the distal end 118 of the outer sheath 38. The implantable device 120 includes a tubular body 122 and can include one or more lateral tubular branches 124. At the crown of the main body 122 or the distal tip of the apex 126, the crown or apex 128 of the side branch 124 can be an eyelet loop 130 to receive a connection string 132 (shown only in FIG. 5C). Any means of circularizing the connecting wire to the end of the side branch 124 can be used, such as a connecting string passing through or a string passing through a window provided by the cell structure terminating in the apex. As illustrated in FIG. 5C, when operatively loaded into the system 30 of FIG. 2A, the main lumen 122 of the device 120 is disposed longitudinally between the outer sheath 38 and the inner member 42. And positioned distal to the distal end 134 of the intermediate member 40.

  To load the implant device into the outer sheath 38, the handle adjustment is set to stretch the stent by extension of 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 handle portions 36a and 36b extend together, the main lumen of the stent is in a stretched or tensioned state. Conversely, as shown in FIG. 8E, when the proximal and distal handle portions 36a and 36b are not elongated, the main lumen of the stent is in an unstretched or non-tensioned state. The distal lumen ends of the inner member 42 and the intermediate member 40 are the connection points for the strings and releasably connected to the openings 122 of the distal and proximal stent main lumens. As discussed above, the side branch stent distal lumen end is releasably connected to the distal end of the side branch catheter.

  FIG. 6A shows a cross-section of the distal portion of the implantation system along line AA in FIG. 5C, and in particular, this cross-sectional view is taken at the distal end of the intermediate member 40. This view shows an outer member 38, an intermediate member 40, an inner member 42 disposed within the central lumen 138 of the intermediate member 40, and a central guidewire lumen 44 of the inner member 40 extending distally through the tip 46. Fig. 5 shows the nesting interrelationship between the main guidewires 48 disposed within.

  The inner member 42 is, for example, a very small diameter catheter in the range of 3 to 8 French for cardiovascular applications, and in addition to the central guidewire lumen 44, the alignment of the connection string is on the distal end of the main stent lumen. A plurality of connection string lumens 140 disposed on the outer periphery of the central guidewire lumen 44 that contribute to directing the connection points to A plurality of lumens 140 are disposed at a distal portion of member 42 and extend along the entire length of inner member 42. The lumen 140 can communicate with one or more flash ports at the handle portion of the delivery system, thereby causing saline to pass through the lumen 140 with greater pressure than the surrounding blood flow to prevent blood flow through the device lumen. Water can flow. Lumen 140 can also be used during the fluoroscopic visualization of the device. To demonstrate that the placement of the stent provides a satisfactory flow pattern and treatment results, the lumen 140 and outlet port 186 described below allow visualization of the dye flowing through the implant at various placement stages. .

  In other embodiments, as illustrated in FIGS. 10A, 10B, and 10C, the connecting string lumen 140 is along only a portion of the entire length of the inner member 40, eg, only a few millimeters from distal to proximal. Can be extended. This embodiment is particularly suitable when only one connection string is used with multiple stent connection points. Here, one string construction material exits one of the distal lumens, passes through the connection point of the stent, passes through another lumen, from distal to proximal, and close to that lumen. Out to pass through another lumen from distal to proximal and through another stent attachment point. The crossing pattern continues until all stent attachment points are joined by a single string passing through multiple peripheral lumens. This connecting string lumen shape that extends only a portion of the length of the inner member can also be used with the intermediate member 40 and side branch catheters 94a, 94b, 94c. For an intermediate member 40 that uses such a string lumen shape, the proximal portion of the intermediate member 40 is one lumen that includes the inner member 42, and the shorter outer lumen is the side branch catheter as well as the main stent lumen. Will include a connecting wire at its proximal end. As can be seen from this embodiment and those discussed below, any combination of knot patterns can be used to connect the individual stent ends to the respective catheters to be coupled.

  Referring again to the embodiment of FIG. 6A, the number of distal connection strings in lumen 140 is twice the number of connection strings in 132, and a pair of adjacent connection string lumens 140a, 140b is connected to each distal connection string. 132 is provided. Thus, the device 120 is fully loaded into the deployment system and the first portion of the distal connection string 132 remains in the lumen 140a and the second portion or return portion of the distal connection string. Remains in lumen 140b.

  In addition to the connecting string lumen 140, there is one or more steering pull wire lumens 142, the function of which is as described above with respect to FIG. Typically, one or two pairs of opposite diameter (180 ° apart) steering pull wires are used to provide the opposite direct refraction of the distal end of the delivery system. As the number of steering pull wire pairs used increases, the steering direction in articulation of the delivery system increases.

  In addition to the central lumen 138 that the inner member 42 translates, the intermediate member 40 includes a plurality of proximal connection strings. The lumen pairs 146a, 146b in which the lumen 146a is shown are located radially outward from the lumen 146b. A connection string connected to or stitched through the proximal parietal (not shown) of the main lumen 122 of the device 120 utilizes the lumen 146. The proximal connection string number of 146 is such that a pair of connection string lumens 146a, 146b provide each proximal connection string, ie, the proximal connection string in which the device 120 is fully loaded into the delivery and deployment system. Twice the number, the fixed end portion of the proximal connection string remains in the lumen 146a and the distal or return portion of the proximal connection string remains in the lumen 146b.

  In addition to the connecting string lumen 146, the intermediate member 40 also provides a plurality of lumens 148, with the central lumen 138 also being located on the outer periphery and inserted between the pair of proximal connecting lumens 146. Preferably, one or more lumens 148 can be used to translate and deliver the side branch catheter 150 (shown in FIG. 6A without details). Side branch catheter 150 provides a central side branch guidewire lumen 152 for delivering and translating side branch guidewire 154. An additional lumen 148 extending from a handle flush port (not shown) is provided for evacuating air from the delivery system 30. In addition, lumen 148 can also be used to rehydrate tissue transplantation coatings or other dressings that are necessary to prepare solutions and potential therapeutic agents such as pharmacological agents, stem cells, or other drugs. Can make it possible. This constrains the stent-graft or other device in the delivery catheter in packaging following dry dehydration, sterilization, rehydration by flushing, and preparation of the catheter at the time of use. The optional unused lumen 148 provides enhanced flexibility of the intermediate member, particularly where the distal end of the device is refractable at multiple contacts.

  7A, 7B and 7C illustrate 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 connecting string lumens 164 arranged on the outer periphery around the central lumen 162. Whether the lumen 164 is annularized through the distal parietal 128 (see FIG. 5A) of the side branch lumen 124 of the device 120 or is utilized by a connection string (not shown) that is sewn. Or occupied. The number of side branch connection string lumens at 164 is twice the number of side branch connection strings, and a pair of connection string lumens 146a, 146b is provided for each side branch connection string, ie, device 120 is within the implantation system. Fully charged. The proximal portion of the side branch connection string remains in the lumen 164a and the distal or return portion of the side branch connection string remains in the 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 thereto. Inner member 176 also has a central lumen 178 for translation and delivery of a side branch guidewire (not shown). The outer member 172 further provides a plurality of side branch connection string lumens 180 with a one-to-one correspondence between the 180 side branch connection string lumen numbers and the side branch connection string numbers (not shown). In this embodiment, the proximal portion of the side branch connection string remains in the space between the inner diameter of the outer member 172 and the outer diameter of the inner member 176, and after annulus formation through the distal connection eyelet, parietal region or cell, The distal or return portion of the string 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 can be composed of two concentric single lumens. One single lumen tube 202 defining an inner diameter and another single lumen tube 203 defining an outer diameter are side branch connections included in a space 201 between the inner diameter of the outer tube 202 and the outer diameter of the inner tube 203. Provide a string. As shown in FIG. 7C, the inner diameter of the inner tubing is used to translate a guidewire (not shown) through the side branch guidewire lumen 204 that is isolated from the connecting string. This lumen shape can also be used with an intermediate member and an internal member.

  Referring to FIG. 6B, there is shown a cross-sectional view taken along line BB of FIG. 5C, particularly through the proximal end of the distal tip 46 where the inner member 42 terminates. The distal tip 46 provides a distal portion of the guidewire lumen 44 as well as a distal lumen portion 182 of the distal connection string lumen 140 of the inner member 42, wherein the plurality of distal lumen portions 182 are axially parallel. There is a one-to-one correspondence with the connecting string lumen 140 of the inner member. Thus, the same pair of adjacent connection string lumens 182a, 182b is provided for each distal connection string 132. That is, the fixed end portion of the distal connection string 132 remains in the lumen portion 182a and the releasable or return portion of the distal connection string remains in the lumen portion 182b. As best shown in FIG. 6C, after passing through the lumen portion 182a, the connection string 132 passes radially from the distal tip 46 through the designated proximal side port 184. The connection string is then annularly formed or sewn around eyelet 130 or parietal or apex 126 or through a very distal cell of main lumen 122 and back through the designated side port 184 of distal tip 46. And re-enters the respective lumen portion 182 and the respective connecting string lumen 140. Thus, for each pair of connection string lumens, there is half the number of side ports 184, ie there is a one-to-one correspondence between 132 connection string numbers and 184 distal tip side port numbers. The distal tip 46 also provides a distal side port 186 to facilitate loading of the string during assembly into the implant delivery system.

  The catheter and / or guidewire used with the system of the present invention can include intravascular ultrasound (IVUS) imaging capabilities, with one or more miniature transducers mounted on the tip of the catheter or guidewire. Provide an electronic signal to the external imaging system. Such a transducer array can be rotated and arteries showing the exact location of removal and removal with respect to a connected branch vessel that accepts a connected branch stent or other lumen into which a catheter is inserted, vascular tissue, and / or perivascular tissue. To create a luminal image. In addition to facilitating visualization during stent delivery and deployment, such a system allows important diagnostic (ie, pretenting) information, such as the location and size of aneurysms not available from conventional x-ray angiography. By enhancing the effectiveness of diagnosis and treatment by providing. How to select a properly sized stent-graft before deploying an unbranched stent for several reasons such as ensuring that the side branch vessel coverage is not inadvertently performed Intravascular ultrasound (IVUS) imaging catheters are commonly used as a preliminary step. Combining imaging capabilities with the tip of a stent delivery catheter has the advantage of saving time by avoiding catheter replacement. A second technique typically performed to avoid replacement of the stent delivery catheter and IVUS catheter through the access site is to acquire another access point to introduce a separate IVUS catheter. By integrating the IVUS transducer on the tip of the stent delivery catheter, the need for a second vascular access wound should be eliminated and the imaging catheter should be delivered through a bilateral cross access location. Also, when placing a stent within another stent, ensure that the second stent is placed within the lumen of the first stent in an overlapping manner to extend the length of the treatment area coating. In order to do this, an IVUS catheter is used. In these cases, the first stent is placed and the downstream portion is buoyant within the large aneurysm sac, so the second stent is placed within the first stent and not outside the lumen of the first stent. Care must be taken to ensure that. Failure to do so may result in accidental occlusion of the blood vessels, necessitating a need to convert the procedure into surgery to remove the misplaced second stent.

Device Implantation Method With respect to FIGS. 8A-8H, and in the context of aortic arch application, a method for implanting the subject device will be described. A stent graft 2 of the present invention, such as that illustrated in FIG. 1A having a main lumen 4 and three side branch lumens 6a, 6b and 6c, is percutaneously implanted in the aortic arch 5 and implanted. At this time, the main lumen 4 remains in the aortic arch 5 and, as illustrated in FIG. 8H, the three side branch lumens 6a, 6b and 6c are respectively connected to the brachiocephalic artery 7a, the left normal carotid artery 7b and It remains in the left subclavian artery 7c.

  As illustrated in FIG. 8A, by the Seldinger technique via the left femoral artery 8 or the abdominal aorta, the main or aortic guidewire 48 is moved to the aortic arch 5 or until the distal tip 48a is intersected with the aortic valve 10. Advance through the system. The catheter portion 32 of the implantation system 30 of the present invention comprises a stent-graft 2 that is manipulated and inserted therein and then percutaneously introduced over the guide wire 48 into the patient's body.

  Alternatively, it is noted that a stent graft or stent coated with a material, such as ECM, requires reconstitution or hydration of the graft or dressing before initiating the implantation procedure. This is accomplished by flushing the gadwire lumen of the delivery system catheter with saline prior to inserting the catheter into the body. Alternatively, this could be done by rinsing with open air before coating.

  When the stent-graft 2 is inserted into the catheter portion 32 and is undeployed, the handle of the delivery system is in the retracted position, i.e., the proximal handle portion 34a and the distal handle portion 34b are engaged with each other. . With the handle of the retracting portion (shown in FIGS. 8B and 8D), the inner member 42 is held in the distal advanced position and the intermediate member 40 is held in the proximal retracted position. This relative axial relationship between the intermediate member and the inner member maintains the stent-graft 2, or at least its main lumen 4, in a stretched or tensioned state. This is because the distal parietal portion of the main lumen 4 is connected to the distal end of the inner member 42 and is in turn secured to the proximal handle portion 34 a, and the proximal parietal portion of the main lumen 4 is connected to the intermediate member 40. This is because it is connected to the distal end and secured to the distal handle portion 36b.

  Next, if necessary, the catheter portion 32 is steered by the operating lever 56 as described above with respect to FIG. 4, thereby deflecting the distal tip of the catheter portion 32 and advancing into the descending aorta then into the aortic arch 5. Let me. It is important that the side branch lumens 6a, 6b and 6c of the stent-graft 2 be positioned with proper rotation so that they are substantially aligned with the delivered arteries 7a, 7b and 7c, respectively. This end catheter 32 can be torqued and fluoroscopic guidance is used to further facilitate delivery of the catheter portion 32. In particular, fluoroscopic markers (not shown) on the top of the stent-graft lumen can be tracked and each can be accurately placed at an optimal location within the artery. The stent itself can be radiopaque. In addition, the catheter tip is radiopaque. Since the stretched main and side branch stent bodies are steered by a refractive bladed guidewire disposed at the target implant site, the steerable guidewire can be used to direct the main catheter 32 and the side branch catheter. .

  Through the delivery and placement procedure, the various lumens of the catheter portion 32 are in a reverse direction (with respect to blood flow) at a pressure that is greater than or substantially equal to the pressure of arterial blood, such as a saline or contrast agent. Can be continuously flushed. This prevents any possible leakage of blood from the system, and in particular does not affect any of the functions of the delivery process while maintaining blood release and transparency in the stent string lumen, thereby eliminating intracoagulation. Prevent interference. 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 delivery and placement system 30 of the present invention ( However, some or all of them can be collectively controlled), and the interconnected cells of the stent can be selectively stretched axially to maintain continuity of blood flow around the device during placement within the anatomy. enable. This axial parallel extension feature also allows for the implantation of larger diameter side branch stents within vessels with smaller diameters.

  Once the distal end of the catheter portion 32 has been operatively positioned within the aortic arch 5, the outer sheath 38 is retracted by manually pulling the attachment component 50 (see FIG. 3A), as shown in FIG. 8C. The proximal end of the nose cone 46 of the inner member 42 is exposed and the distal portion of the main or aortic lumen 4 of the stent graft 2 in the ascending aorta is partially placed. Due to the partial placement of the stent graft 2, the main aortic lumen 4, the arterial blood flow leaving the aortic valve 10 flows through and around the main lumen 4. Without mentioning the avoidance of the resulting endothelial damage and / or the likely plaque embolization, this partially deployed main lumen 4 allows the stent-graft 2 to not yet engage with the vessel wall, It is therefore important to note that it can be easily repositioned within the vasculature because it has not been subjected to frictional resistance that would be caused by contact with the wall.

  If the various side branch lumens 6a, 6b and 6c of the stent-graft 4 can be placed sequentially (one at a time) or in parallel (simultaneously) together in any order, they are placed distally It is easiest to place one side branch stent lumen at a time in the order from the stent lumen (6a) to the most proximally placed stent lumen (6a). This arrangement order eliminates unnecessary or repeated translation of the outer sheath 38 on the stent-graft, i.e., gradually only unidirectional (proximal) translation is required. This has the advantage of minimizing wear on the implant material, which is particularly important when coated with a material such as an extracellular matrix or drug. This placement order further reduces the required placement steps and thus reduces the total time required for the transplantation procedure.

  In order to deploy a side branch stent lumen, such as stent lumen 6a, side branch guidewire 154 is pre-loaded into (or into) each adjustment hub side branch port 110 in its fully distally advanced position. And inserted into the lumen 152 of the side branch catheter 150 disposed in the lumen 148 of the intermediate member 40 (see FIG. 6A). At the same time, as shown in FIG. 8C, the outer sheath 38 is gradually withdrawn proximally in increments so that the distal end of the guidewire 154 passes through the side branch catheter 150 from its distal end to the anonymous artery 7a. To translate. Next, as shown in FIG. 8D, each adjustment hub 74 can be translated distally along the intermediate member 40 and fully engaged with the associated catheter hub 84, thereby connecting strings connected thereto. The side branch stent 6a is partially arranged by applying the maximum tension applied to the side branch stent cells. The main stent cell retains the distal to proximal stretched relative position of the inner and intermediate members controlled by a similarly shaped handle, while the side branch stent has a distally advanced side branch Note that it is similarly maintained in the extended position by the catheter. As illustrated in FIG. 8D, this procedure is repeated as necessary for the number of remaining side branch stents, in this case for side branch stents 6b and 6c delivered to the left normal carotid artery 7b and left subclavian artery 7c, respectively. . In this partially deployed state, blood flow is around the device, and depending on the length of extension that the intimate method and connecting string is pulled to the outlet port 184 of the internal member, blood flow passes through the implant. Please pay attention to. It is desirable to have a blood flow that does not pass around the device and through the lumen of the device, which can be achieved by securing it to a connection string on the distal end of the main lumen, by connecting a minimum length, Closed and held 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 is controllable by the length of the distal connection string, which adjusts and selects the position where the clamp locks on the distal connection string It is important to note that this is controlled by the string clamp 70b. This adjustment can be made in situ while the stent is delivered. Similarly, the distance between the proximal end of the main stent and its connection to the intermediate member can be controlled by the length of the proximal connection string, which determines the position at which the clamp locks on the proximal connection string. Controlled by string clamp 72b by adjustment and selection. This adjustment can be made in situ while the stent is delivered.

  After placement of all side branch stents into the branch artery in the partially deployed state, the stent-graft is fully ready for deployment. This is accomplished by moving the system handle to the extended position, ie, the proximal handle portion 34a and the distal handle portion 34b are separated axially parallel to each other, as shown in FIG. 8E. This action brings the lumen ends closer together by translating the inner member 42 proximally with respect to the fixed intermediate member 40 and then relaxing the tension applied to the cells of the main lumen 4. Thus, the stent is shortened and the diameter of the main lumen 4 is correspondingly increased, thereby fixing the main lumen 4 against the aortic wall.

  Similarly, the side branch catheter is translated proximally by moving each adjustment hub 74, 76, 78 at a further distance from its corresponding catheter hub 84, 86, 88, thereby being applied to the cells of the side branch stent. Relax the tension. For this reason, since the lumen end is shortened, the diameters of the side branch lumens 6a, 6b and 6c correspondingly increase. The distance between the stent end and the catheter end is the length of the string that is moved between the fixed end knobs 70a, 72a, 74a, 76a, 78a and the releasable end clamps 70b, 72b, 74b, 75b, 78b. It is important to note that it can be controlled by adjusting.

  When the stent cells are released from their tension by translation of the catheter handle and side branch catheter, the stent opens to a diameter that is expanded against the surrounding arterial wall so that the total blood flow is distant from the device. Enter through the end and exit from all other lumens. Once the stent is fully deployed, the blood flow is preferably sealed from the outer periphery of the stent-graft.

  As shown in FIG. 8E, even if the stent itself can be fully deployed, it is connected to the inner member 42, each of the distal ends of the intermediate member 40, and to each side branch catheter 150a, 150b, 150c by a set of connected strings. Still connected. Here, the lumen end of the stent-graft can be removed from the respective catheter. The luminal ends of the stent graft can be released sequentially (one at a time) or in parallel (simultaneously) together in any order. As shown in FIG. 8F, the lumen ends of the side branch lumens 6b and 6c are released by their respective connection strings 190, and the side branch catheters 150a, 150b, 150c and the side branch guidewire 154 are retracted. . For each side branch lumen end as illustrated in side branch lumen 6a, a designated adjustment clamp 74b on the respective catheter hub 74, 76, 78 to release the free end of string 190 from the catheter hub screw clamp. , 76b, 78b, and at the same time by removing the adjustment knobs 74a, 76a, 78a from the handle, and to the extent that the annulus is released or removed from the crown 128 of each stent in FIG. 8F. By pulling 190, removal and removal of the catheter is accomplished. The strings 190 need only be pulled until their free ends release the crown but can be retracted into the distal end of the catheter portion 32.

  As illustrated in FIG. 8G, a similar approach is performed with respect to the arrangement of the distal and proximal ends of the main lumen 4, so that either end is placed first but both ends are placed simultaneously. May be. The designated adjustment clamps 70b, 72b are actuated to release the string 192, while the adjustment knobs 70a, 72a are unrolled or removed from the top of each stent 126 by being removed from the handle. Pull string 192 as much as possible. Their free ends release the crown, but string 192 may be pulled until it can be retracted into the distal end of catheter portion 32. Next, as shown in FIG. 8H, the entire catheter portion 32 can be removed from the vasculature by the stent-graft 2 with it fully positioned within the aortic arch 5.

  Referring now to FIG. 11, the partial placement step of the above approach is illustrated with respect to delivery and placement of the implant 210 of FIG. 1E. Specifically, the catheter portion 38 of the delivery system is partially within the distal portion of the main stent lumen 122 and the left and right coronary arteries 220 and 222, respectively, which are partially disposed within the aortic root and ascending aorta 240. Are placed in the aorta by side branch lumens 214a and 214b. The main guidewire 218 extends from the catheter 38 and intersects the position in front of the natural aortic valve 224, and the side branch guidewires 226 and 228 extend from the side branch catheters 230 and 232 into the coronary arteries 220 and 222, respectively. . Upon release of the connection string to the main lumen of the implant, the prosthetic valve 216 remains in the natural annulus 224. The side branch lumens 214a, 214b can be placed simultaneously with each other and the main lumen 212 or sequentially in any order.

  In any surgical or endovascular procedure, such as those just described, the fewer incisions made in the patient, the better. Of course, this often requires highly specialized instruments and instruments used by highly skilled surgeons or physicians. In view of this, the single incision device implantation method described above facilitates the initial delivery of the catheter portion 38 of the delivery system 32 at the implantation site and the proper placement of the stent-graft during its placement at the site. To further ensure orientation, it can be modified to include the creation and use of one or more secondary incisions.

  The two incision (or multiple incision) approach of the present invention includes a primary incision, eg, an incision in the femoral artery, through which the delivery and placement system passes into the first blood vessel in the body, eg, the aortic arch. A second incision (or more) is included at a location that provides access to at least one blood vessel that is introduced and intersects the first blood vessel, eg, one of the side branches of the aortic arch. This approach is described with reference to FIGS. 12A-12F, where a primary incision made in the left femoral artery 8 to access the aortic arch 5 and a brachiocephalic artery or flexion to access one or more arteries of the aortic tree. The use of a secondary single incision made in the bone artery 15 will be described in the context of implanting the stent-graft 2 of the present invention in the aortic arch.

  A first and second access incision is made--to the left femoral artery 8 and the left short head artery 15, respectively. A second or “tethered” guidewire 300 is advanced through the left short head artery 15 and into the anonymous artery 7 by the Seldinger method. The guide wire 300 is then further advanced into the aortic arch 5, descending artery 11, abdominal aorta 13 and left femoral artery 8, as shown in FIG. 12A, where it exits the body through a femoral incision. Then, as shown in FIG. 12B, a second, or “tethered” guidewire 302 is passed over the femoral end 300a of the guidewire 300 and along the entire length of the guidewire until the catheter 302 is advanced through the brachial incision. Any suitable standard system for cardiovascular applications can be used as the second or anchoring guidewire and catheter. A dual lumen rapid exchange (RX) catheter having a second lumen located at the proximal end of the catheter 302, such as that shown. The advantage of the RX catheter is that it is not a long distance that is difficult to push it due to the nature of the flexible string, but only a relatively short distance (necessary) to push the string (or guide wire) before exiting the lumen. Is less “pushability”). Alternatively, as shown in FIG. 12C ', at the extreme end of the catheter 302, the catheter wall can be provided with a through hole or a cross hole.

  The implantation system 30 is then equipped with the stent graft 2 operatively loaded therein. As shown in FIG. 12C, the most distal side branch stent lumen 6a (ie, intended to be implanted in the anonymous artery 7a) and connected (at one or more stent heads) A side branch connection string 190, or at least one string thereof, for deployment is extended from the side branch catheter 150a of the main or stent delivery system catheter 38 and then passed through the side branch anchoring tubing 35. Next, a knot 37a is made in the string to prevent the base from being drawn into the catheter 150a and tubing 35. The remaining distal length of string 190 is then passed through the exchange lumen 304 of anchoring catheter 302. A second knot 37b is then made at the end of the string to prevent the base from being withdrawn from the exchange lumen 304. The second catheter embodiment of FIG. 12C ′ passes the string through the main lumen 302 and out of the side hole 305. A knot 37b is then made at the distal end.

  Then, as shown in FIG. 12D, the second catheter 302 that has pulled the side branch catheter 150a until the catheter 302 is fully withdrawn from the brachial incision and the distal end of the side branch catheter 150a is also withdrawn from the brachial incision, and the first Alternatively, the entire stent catheter 38 including the main guidewire 48 is returned through the femoral incision on the second guidewire 300. Here, the mooring guidewire 300 can be removed from the body. At this point, the string 190 is cut at a location 307 between the distal end of the side branch catheter 150a and the opposite end of the second catheter 302 to release the anchoring catheter 302 from the stent deployment system.

  In the partially deployed state (ie, exposed but stretched), due to the tension applied to the string 190 and its translational movement, as shown in FIG. It is drawn into the artery 7a. At the same time, the stent guide wire 48 is advanced over the aortic arch 5 and beyond the aortic valve 10, thereby entering the nose cone 46 and thus partially positioned (ie, exposed but stretched). The distal end of the main stent lumen 4 (which is either tensioned or taut) is advanced into the ascending aorta. Meanwhile, the stent catheter 38 is advanced over the stent guide wire 48 and into the aortic arch 5. Continuous forward advancement of the stent catheter 38 is hindered by the partially placed side branch lumen 6a. As discussed above, holding the main lumen 4 in a stretched or tensioned state (similar to the side branch lumen 6a) provides various advantages: arterial blood flowing out of the aortic valve 10 Flow can flow to the brain and body; repositioning of the stent-graft 2 is possible, and endothelial damage and / or plaque embolization from the aortic wall is greatly minimized.

  As in FIG. 12F, for stents and stent-grafts having two or more side branch lumens 6a, 6b, 6c, the operations described above and shown in FIGS. 12A-12E with respect to the implantation of a stent having one side branch lumen. Are performed simultaneously by separate designated anchoring guidewires and catheters 150a, 150b, 150c. As shown in FIG. 12F, at least the distal end of the main stent lumen 4 is accurately positioned and partially positioned within the ascending aorta so that each side branch lumen, 6a, 6b, 6c, respectively, They are placed in the anonymous artery 7a, the left common carotid artery 7b, and the left subclavian artery 7c. Alternatively, one or more side branch lumens can be partially placed as described with respect to FIGS. 12A-12F, and if there is a remaining side branch lumen, it can be placed in the manner described above with respect to FIGS. 8C and 8D. . Finally, in order to fully deploy all the lumens of the stent-graft, all side branch lumens, 6a, 6b, 6c are partially positioned within their respective arteries, with reference to FIGS. The described operational steps can be performed and the delivery system is removed from the body.

  While the implant of the present invention has been described as being disposed by an elongated member, ie, a string, it will be appreciated that the luminal end of the implant is configured for deployment by the expandable member (s). The implant can be configured. For example, by placing each of the implanted undeployed implant ends (ie, the main lumen and the side branch lumen) around an inflatable balloon secured to a catheter, one or more Can be coupled to a nested catheter. Enough with the implant end so that when the balloon is manipulated with the balloon in a partially or fully inflated state, the lumens of the implant are selectively stretched or pulled along their entire length. A close fit is provided.

  What has been illustrated above is merely the principle of the invention. Those skilled in the art can devise various measures and embody the principles of the present invention, even if not explicitly described or shown herein, which are within the spirit and scope of the present invention. Included in range. Furthermore, all examples and conditional terms listed herein primarily help the reader to understand the principles of the invention and the concepts contributed by the inventor and promote the industry. It is intended and should not be considered as being limited to such specific examples and conditions. Moreover, all statements describing principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Also, such equivalents are intended to include both currently known and future developed equivalents, i.e., any element developed that performs the same function regardless of structure. Has been. Accordingly, the scope of the invention is not intended to be limited to the exemplary embodiments shown and described herein, but the scope and spirit of the invention is embodied by the appended claims.

The invention is best understood from the following detailed description when read in conjunction with the accompanying drawings. It is emphasized that, according to common practice, the various features of the drawings are not a fixed reduction ratio. On the contrary, the dimensions of the various features are arbitrarily expanded or reduced for clarity. Also, for purposes of clarity, certain features of the invention may not be depicted in some of the drawings. The following figure is included in the drawing:
FIG. 1A shows an embodiment of the implant of the present invention in a naturally deployed state. FIG. 1B shows another embodiment of the implant of the present invention in a naturally deployed state. FIG. 1C illustrates another embodiment of an implant in which the side branch lumen is bent at an angle. FIG. 1D is an end view of the implant of FIG. 1C. FIG. 1E illustrates another embodiment of the implant of the present invention having a heart valve operably coupled to the implant of the present invention. FIG. 2A is a perspective view of the system of the present invention for delivering and placing the implant of the present invention within a tubular tissue structure in the body. FIG. 2B is an enlarged perspective view of the system portion of FIG. 2A including the side branch control device and the catheter hub. FIG. 3A is a side view of the side branch control device and catheter hub in the open and closed configurations of the systems of FIGS. 2A and 2B, respectively. FIG. 3B is a side view showing the side branch control device and catheter hub in the open and closed structures of the systems of FIGS. 2A and 2B, respectively. FIG. 4 is a side view of the handle portion of the system of FIG. 2A. FIG. 5A is a side view showing the distal end of the delivery and placement system of the present invention with the implantable device of the present invention partially deployed from the implantation system. FIG. 5B is a top view of the system and implantable device of FIG. 5A. FIG. 5C is a cross-sectional view in the major axis direction 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 showing the tip portion of the catheter of the delivery and placement system of FIG. 5C. FIG. 7A is a cross-sectional view showing a possible embodiment of the side branch catheter of the present invention. FIG. 7B is a cross-sectional view illustrating a possible embodiment of the side branch catheter of the present invention. FIG. 7C is a cross-sectional view illustrating a possible embodiment of the side branch catheter of the present invention. FIG. 8A illustrates the various steps of the method of the present invention for delivering the stent of the present invention using the implant system of the present invention. FIG. 8B illustrates the various steps of the method of the present invention for delivering the stent of the present invention using the implant system of the present invention. FIG. 8C shows the various steps of the method of the invention for delivering the stent of the invention using the implantation system of the invention. FIG. 8D shows the various steps of the inventive method for delivering the inventive stent using the inventive implantation system. FIG. 8E illustrates various steps of the inventive method for delivering the inventive stent using the inventive implantation system. FIG. 8F illustrates the various steps of the method of the present invention for delivering the stent of the present invention using the implant system of the present invention. FIG. 8G illustrates the various steps of the inventive method for delivering the inventive stent using the inventive implantation system. FIG. 8H illustrates various steps of the inventive method for delivering the inventive stent using the inventive implantation system. FIG. 9 illustrates another embodiment of the handle portion of the delivery and placement system of the present invention. FIG. 10A is a side view illustrating an embodiment of an internal member of the catheter portion of the delivery and placement system of the present invention. 10B is a side view showing the internal member of FIG. 10A along the line BB of FIG. 10A. 10C is a side view showing the internal member of FIG. 10 along the line CC in FIG. 10A. FIG. 11 shows a partial arrangement of the implant of FIG. 1E within the aortic root. FIG. 12A illustrates various steps of another method of the present invention for delivering a stent of the present invention using the implantation system of the present invention. FIG. 12B shows the various steps of another method of the present invention for delivering the stent of the present invention using the implantation system of the present invention. FIG. 12C is a diagram illustrating various steps of another method of the present invention for delivering a stent of the present invention using the implantation system of the present invention. FIG. 12D shows the various steps of another method of the present invention for delivering the stent of the present invention using the implantation system of the present invention. FIG. 12E illustrates various steps of another method of the present invention for delivering a stent of the present invention using the implantation system of the present invention. FIG. 12F illustrates various steps of another method of the present invention for delivering a stent of the present invention using the implantation system of the present invention. FIG. 13A shows various exemplary mandrel designs for making the stents and stent-grafts of the present invention. FIG. 13B illustrates various representative mandrel designs for making the stents and stent-grafts of the present invention. FIG. 13C shows various representative mandrel designs for making the stents and stent-grafts of the present invention. FIG. 14 is a diagram showing a typical wire braiding pattern for forming the stent of the present invention. FIG. 15 illustrates one manner of implanting the stent of the present invention.

Claims (50)

A main lumen having a proximal end and a distal end constructed from a bent wire in a lumen shape;
At least one side branch lumen constructed from wire and interconnected with the main lumen;
An implantable coated stent, wherein at least a portion of the stent is coated with an extracellular matrix.   The stent according to claim 1, wherein the main lumen has an expanded cross-sectional dimension X and a reduced cross-sectional dimension where Y is less than half of X.   The stent according to claim 2, wherein Y is less than one fifth of X.   The stent according to claim 3, wherein Y is less than one tenth of X.   Each of the main lumens and the at least one side branch lumen have an unconstrained structure and a constrained structure, and when the stent is an unconstrained structure, the length of the main lumen is from about 1 cm to about 25 cm The stent of claim 1, wherein the length of the at least one side branch lumen is in the range of about 0.5 cm to about 6 cm.   When the stent is an unconstrained structure, the length of the main lumen is in the range of about 8 cm to about 25 cm, and the length of the at least one side branch lumen is in the range of about 2 cm to about 6 cm. The stent according to claim 5.   When the stent is an unconstrained structure, the length of the main lumen is in the range from about 2 cm to about 5 cm, and the length of the at least one side branch lumen is from about 0.5 cm to about 3 cm. The stent according to claim 5 in the range of.   The stent according to claim 1, wherein the wire is a single wire woven into a pattern of interconnected cells, forming the main lumen and the at least one side branch lumen.   The stent of claim 8, wherein the wire has a diameter from about 0.004 inches to about 0.02 inches.   The wires forming the side lumens form a pattern of interconnected cells, and the size of the cells decreases from the point where the side lumens are interconnected to the main lumen, and the free ends of the side lumens The stent of claim 1, which continues to decrease.   The stent according to claim 1, wherein the orientation of the at least one side branch lumen is adjustable with respect to a crossing angle with the main lumen.   The stent of claim 1, wherein the at least one side branch lumen is adjustable relative to a distal end and a proximal end of a main lumen.   The at least one side branch lumen is adjustable with respect to a crossing angle with the main lumen and further adjustable along the main lumen with respect to a distal end and a proximal end of the main lumen. The stent according to claim 1.   The stent according to claim 1, wherein the shape of the main lumen is selected from a linear cylindrical structure, a curved tubular structure, and a tapered hollow structure, and the wire is made of a super elastic memory material.   The stent according to claim 1, wherein an extracellular matrix is coated around the wire.   The stent according to claim 1, wherein the extracellular matrix is a sheet coating the outer circumference of the main lumen and the branch lumen.   The stent according to claim 1, wherein the extracellular matrix further comprises a growth factor.   The stent according to claim 1, wherein the extracellular matrix further comprises a compound that enhances cell adhesion.   The stent of claim 1, further comprising a plurality of side branch lumens wherein the spacing between adjacent side branch lumens is adjustable along the main lumen and relative to another side branch lumen.   The stent of claim 1, further comprising a first string attached to the stent and extending beyond a proximal end of the main lumen.   21. The stent of claim 20, further comprising a second string attached to the stent and extending beyond a distal end of the main lumen.   The stent of claim 1, further comprising a plurality of strings removably coupled to the stent at a plurality of different points. A main lumen having an open proximal end and an open distal end, a closed structure extending therebetween; and at least one side branch lumen interconnected with and in fluid communication with the main lumen;
A blood vessel in which at least one main lumen and at least one side branch lumen are adjustable in relation to their angle or orientation relative to the main lumen, publishing at a location along the main lumen Or an implantable stent for placement within a tubular structure.   24. The stent of claim 23, further comprising side branch lumens disposed axially around each other along the main lumen.   24. The stent of claim 23, wherein the main lumen and the at least one side branch lumen each have an adjustable length and diameter.   24. Assembled from a single wire woven into a pattern of interconnected cells, wherein the main lumen has a shape selected from a linear cylindrical shape, a curved tubular shape and a tapered hollow shape. Stent.   The at least one main lumen and the end of the at least one branch lumen are flared and the stent is coated with at least one pharmaceutically active ingredient that is released at a control site. 24. A stent according to claim 23.   24. The stent of claim 23, further comprising a coating with cells to promote angiogenesis.   24. The stent of claim 23, further comprising a porous coating adapted for tissue growth.   24. The stent of claim 23 further comprising an extracellular matrix material.   24. The stent of claim 23, further comprising a marking element for providing an orientation indicator for the main lumen and the side branch lumen.   Further comprising a plurality of points along the entire length of the stent to receive one or more removable strings, thereby providing a selective knitting of the plurality of points in the main lumen. 24. The stent according to claim 23, wherein the correlates permit angular orientation of at least the side branch lumen. Each of the at least two side branch lumens is defined by an orientation with respect to the main lumen defined by the first angle and an axial orientation with respect to the other side branch lumen defined by the second angle, and a third angle. A rotational orientation with respect to another side branch lumen; and the first angle ranges from about 10 ° to about 70 ° and the second angle ranges from 0 ° to about 170 °. 24. The stent of claim 23, further comprising a plurality of side branch lumens, wherein the third angle ranges from about 0 degrees to about 360 degrees.   34. The one or more of the orientations can be adjusted during delivery and placement of a branch lumen within a blood vessel or tubular structure, and the length and diameter of at least one side branch lumen is adjustable. The described stent. A method of making an implantable device having a main lumen and at least one side branch lumen, the method comprising:
Wrapping the entire length of the wire around the pins of the mandrel device, the mandrel device including a main mandrel and at least one side mandrel extending substantially orthogonal from the main mandrel, wherein the main mandrel and at least one Each of the side mandrels has a plurality of pins extending therefrom;
The wrapping wire forms interconnected cells, the cells of the main mandrel form the main lumen of the implantable device, and the cells of the at least one side mandrel are at least one side branch of the at least one side branch lumen A method wherein a lumen is formed and cells of said main lumen are interconnected with cells of at least one side branch lumen.   36. The method of claim 35, further comprising heating the mandrel device and the winding wire to a selected temperature; and cooling the mandrel device and the winding wire.   The method of claim 36, wherein the selected temperature ranges from about 480 ° C to about 520 ° C.   The method of claim 36, wherein the selected temperature is about 490 ° C.   36. The method of claim 35, further comprising the step of coating an extracellular matrix material on at least a portion of the formed implantable device. A device configured for implantation into a site within a body vasculature having a main vessel and at least one crossed side vessel, the device comprising:
A main lumen having a proximal end and a distal end; a main lumen configured to be disposed within the main vessel; and at least one side branch lumen extending from the main lumen and having a distal end Comprising at least one side branch configured to be placed in a side branch vessel;
A device wherein each of the device ends is configured to releasably receive one or more strings, wherein the device ends can be selectively placed by the strings.   41. The device of claim 40, wherein the device is formed from one or more groups of one wire, a plurality of wires, a tube material and a sheet material.   41. The device of claim 40, wherein the device comprises at least two side branch lumens and the distance between the two side branch lumens is adjustable.   41. The device of claim 40, wherein an angle at which the at least one side branch lumen intersects a main lumen is adjustable within a selected range.   When the graft material is partially deployed, it is in a longitudinally extending state, the main lumen is configured to be disposed within the aortic arch, and at least one side branch lumen is disposed in the aorta 41. The device of claim 40, wherein the device is configured to be placed in a branch vessel that extends from the arch.   41. The device of claim 40, wherein the device is selectively releasable from the delivery system by one of the group consisting of a connection string, electrolyte erosion, thermal energy, magnetic means, chemical means and mechanical means.   41. The device of claim 40, wherein the device further comprises an auxiliary device attached thereto, wherein the auxiliary device is selected from the group consisting of a prosthetic valve, a sensor or an electrode operably connected thereto.   47. The device of claim 46, wherein the auxiliary device is an artificial heart valve.   41. The device of claim 40, wherein the main lumen is configured to be disposed within an aortic root and at least one side branch lumen is configured to be disposed within a coronary artery.   41. The device of claim 40, wherein the main lumen is configured to be disposed within the abdominal aorta and at least one side branch lumen is configured to be disposed within the renal artery. 41. The device of claim 40, wherein at least a portion of the device is coated with an extracellular matrix material.

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