JP5955266B2 - Method and system for clipping intravascular and repairing intracavitary and tissue defects - Google Patents

Description

  The present invention relates to general systems and methods for treating defects in lumens such as mammalian blood vessels and gas flow paths using minimally invasive techniques. More specifically, a system that uses minimally invasive techniques to occlude, clip, and treat defects in human and animal ecosystems such as aneurysms, vascular irregularities, septal defects and other tissue defects, and flow path irregularities. And the method.

  Surgical procedures for repairing body lumens and tissues and closing openings, such as blood vessels, septal defects, and other physiological defects, are highly invasive. For example, in a surgical procedure in which an aneurysm is sandwiched between clips, the skull is opened, the brain tissue covering the upper layer is incised or removed, and the aneurysm is clipped to repair the blood vessel. Return to and close the skull. Surgical techniques used for septal defects are also highly invasive. The risk of anesthesia, bleeding, infection, etc. during or after this type of treatment is high, and the tissue that has undergone surgery may become dysfunctional.

  As a minimally invasive technique, a technique of installing an occluding device in a body opening such as a blood vessel, a spinal column, a fallopian tube, a bile duct, or a bronchial airway, or a body lumen is used instead. In general, the implantable device is guided to a desired place by a delivery catheter, and is pushed out from the distal end opening of the delivery catheter by an extrusion mechanism such as a pusher or a delivery wire, and is placed on a treatment target part. After the occlusion device is installed, the pusher mechanism is withdrawn without damaging the occlusion device or surrounding tissue.

  An aneurysm is a raised portion that occurs in an artery and is generally caused by weakening of the arterial wall, forms an opening or lumen, and is a site that often causes intracerebral hemorrhage or stroke. The purpose of the minimally invasive treatment is to prevent substances collected in the lumen from entering the blood vessels and blood flow from entering the aneurysm. For this purpose, various kinds of substances and devices are used.

  Various embolic materials and devices reduce the risk to the patient regarding aneurysms. One type of embolic material includes injection fluids and relaxation agents such as microfiber collagen, polymer beads, and expandable polyvinyl alcohol. These polymeric substances are associated with the persistence of the substance in blood vessels. These substances are injected into the blood vessel through the catheter. Some substances exhibit excellent occlusion in a short period of time, but are usually absorbed into the blood and allow recanalization. In addition, suspensions using hog hair or metal particles have been proposed and used to promote aneurysm occlusion. Polymer resins such as cyanoacrylate are also employed as injecting substances for vascular occlusion. These resins are usually used by mixing with a radiopaque substance, or added with tantalum powder to make it radiopaque. These materials are difficult or impossible to retrieve once they have been placed in a blood vessel.

  Implantable metal vessels for vascular embolization are also widely known and used. Many vascular embolic devices are made of a helical coil or shape memory metal, and are discharged from the distal end of the delivery catheter to form a desired shape. The coil is intended to fill the space formed by the defect and promote the formation of an embolus. A plurality of coils of the same or different types can be continuously implanted in one aneurysm. To stabilize the wall of the aneurysm, the skeletal structure can also be implanted before inserting an embolic material such as a coil.

  In transporting the vascular embolus device to the target site, generally, a transport catheter and a detachment mechanism for detaching the coil from the transport catheter after installing the coil at the target site are used. First, a microcatheter is guided through the delivery catheter to the vicinity of the aneurysm entrance. Usually, a guide wire is used. Withdrawn from the guide wire or microcatheter, an implantable intravascular occlusion coil is placed. The intravascular occlusion coil advances through the microcatheter, is discharged from the microcatheter, and is placed in the aneurysm or vascular deformity. Transplantation and maintenance of vascular embolic devices is extremely important. The movement and insertion of vascular embolizers depends on blood flow and anatomy and poses serious health risks.

  One type of aneurysm known as a “wide neck aneurysm” is said to be difficult to place and hold an intravascular occlusion coil. A wide neck aneurysm is generally an aneurysm consisting of a vascular wall having a neck or entropy zone wider than the diameter of the aneurysm. It has been clinically confirmed that it is difficult to place.

  Placing coils and other embolic materials within the aneurysm cavity has not been successful enough. The placement procedure requires continuous installation of a plurality of embolic devices such as coils in the blood vessel cavity, which is difficult and time consuming. Long-term treatment increases the risk of complications, bleeding, infections, etc. from the aneurysm. Furthermore, even if a substance is placed in the space within the aneurysm, the opening is generally not completely blocked, and recanalization is likely to occur. There is a risk of other complications. After the embolic material has flowed out, the blood also flows into the aneurysm and into the vascular malformation, increasing the risk of complications and further expansion of the aneurysm. In addition, there are aneurysms and defects where conventional coils and embolic devices do not fit well.

  Devices have been proposed to hold a vaso-occlusive coil within an aneurysm. One such device is disclosed in US Pat. No. 5,980,514. This device is placed in the feeding vessel lumen of the aneurysm and holds the coil within the aneurysm. The device is fixed by the high pressure acting on the vessel wall. After placing the device in place, the microcatheter is inserted from behind the holding device and the distal end of the catheter is inserted into the vessel lumen to place the vascular obturator. This holding device prevents movement of the occlusion device from within the vessel lumen.

  Another method for occluding an aneurysm is the vascular occlusion device disclosed in US Pat. No. 5,749,894. This device consists of a coil or string and has an outer surface made of a polymer composition that forms a barrier upon solidification. The polymer compound is activated by light irradiation, melts, and forms a polymer surface outside the vascular occlusion device. The device sticks to various sites and forms a solid mass within the aneurysm.

  Devices that span the neck of an aneurysm have also been proposed. For example, US application 2003/0171739 A1 discloses a neck bridge having a plurality of array elements attached to a branch and a cover attached to the array element or the branch. Nitonol alloy can be used for the array element, and fibers, meshes, and other sheet-like structures can be used for the cover.

  US Patent Application No. 2004/008799 discloses a device for fixing a defect obturator with two sheets or one sheet and one strut structure to close the opening, and a blood vessel occlusion method. Yes. This publication lists a number of biocompatible materials and substances used to promote adhesion, fibrosis, tissue growth and endothelial growth.

  U.S. Patent Application No. 2004/0193296 discloses a device for occluding at least a portion of an aneurysm, wherein the device moves relative to each other to form a bridge between the delivery portion and the placement portion. The elongate member. Two array bridges are also disclosed in which the first array is placed inside the aneurysm and the second array is placed outside the aneurysm.

  Devices for occluding septal defects are also well known. Such devices occlude lumens and defects in the heart and vascular system. For example, US Pat. No. 6,077,291 and US Pat. No. 6,911,037 disclose septal occlusion devices. Bronchial blood flow regulating devices that seal the bronchial lumen or seal a portion are also known, see for example US Pat. No. 7,011,094.

  Currently used means to disengage the implantable device after placement include mechanical techniques, electrical techniques, and hydraulic techniques. In the mechanical approach, the occlusion device and pushwire are coupled by a mechanical connector or internal lock, and once removed, the device is ejected from the catheter. Examples of such devices are disclosed in US Pat. Nos. 5,263,964, 5,304,195, 5,350,397 and 5,261,916.

  In the electrical method, the pusher wire and the closing device are connected to each other in a bonded state constituted by fibers and an adhesive. After the device is placed in the desired location, the bond is electrolyzed by the operator with current or heat (eg, using a laser). An example of such a device is disclosed in US Pat. No. 5,624,449. Such devices have the disadvantage that the material generated by electrolysis is released into the aneurysm, posing a potential risk to the patient. Electrical detachment takes time to place the occlusion device.

  In the method using water pressure, the push wire is connected to the occlusion device by coupling polymerization. The push wire has a micro lumen for the operator to connect a hydraulic injection from the proximal end of the wire. When pressure is applied to the injection part, the water pressure increases, the coupling polymerization part is destroyed, and the device is detached. An example of such a device is disclosed in US Pat. No. 6,689,141.

  Although various occlusion devices and methods for defects using known minimally invasive techniques are known, these techniques are still dangerous and, even if they successfully occlude the opening, physiological structures, usually There is little to be restored to the health status of. The method and system of the present invention reduce the length and complexity of minimally invasive procedures for obstructing openings, treating tissue defects, repairing physiological structures such as blood vessels, and restoring normal health. is there.

  The present invention relates to methods and systems for repairing lumen openings or cavities by using minimally invasive techniques. Generally, these systems and methods are used for vascular abnormalities such as openings and intracavities, and are disclosed herein for application to aneurysms and other vascular defects. However, the system and method according to the present invention are not limited to these applications, and can be applied in various forms to repair and restore desired openings, cavities, and tissues. Is natural.

  As one embodiment, the method and system according to the present invention includes disposing an occluding structure over an opening or a cavity, and cutting the opening or cavity such as an aneurysm into the opening or cavity. The lumen, such as a blood vessel, is repaired and restored by holding the occlusion structure in the opening using one or more anchor structures that act as a means for removal from the parent artery. After placement, the occlusion structure covers the opening and the cavity to form a continuous lumen wall that is almost the same as the healthy lumen wall. Neither the anchor structure nor the occlusion structure will interfere with blood flow within the lumen. Various substances such as substances that promote the growth of endothelium and tissues, adhesives, therapeutic agents, and non-thrombogenic substances can be provided to the repair site during or after the treatment.

  In another embodiment, the method and system according to the present invention includes placing an occlusion structure that restricts cell transmission of a defect across an opening, said occlusion structure using one or more anchor structures. Defects such as aneurysms are removed by holding in the opening. The method and system according to the present invention further promotes the reduction or reabsorption of a defect or part thereof and promotes hemostasis within the defect. In addition, the method and system for treating an aneurysm according to the present invention not only restores the structure and function of blood vessels around the defect, but also stabilizes the substance inside the aneurysm and allows debris to enter the bloodstream. Prevent the aneurysm size and mass.

  Intraluminal and intravascular procedures are commonly used to install implantable devices and materials used in various types of medical practices. The intravascular guide catheter is inserted into the patient's blood vessel through the femoral artery and reaches the desired treatment site through the blood vessel. It can be employed to prepare transport for various types of devices and accessories, including additional transport mechanisms, special catheters, microcatheters and pusher devices. The implantable device is generally detachably attached to a pusher or a delivery mechanism, guided to a target portion through a guide catheter, and then deployed and separated from the delivery mechanism. The delivery mechanism is pulled back through the guide catheter, and additional devices, auxiliaries, medications, etc. are delivered to the target site prior to removal of the guide catheter if necessary.

  The method according to the present invention includes guiding a device having an occlusion structure and one or more anchor structures to a desired repair site in a small diameter delivery state using minimally invasive techniques. In one embodiment, the tide wire is guided through the guide catheter to the targeted repair. The occlusion device is guided to the targeted repair and deployed at the tip of the guide wire. As a preferred embodiment, the occlusion device is preferably pre-attached to the distal end of the delivery catheter. Guidewires, delivery catheters, occlusion devices, pushers, separation devices are of appropriate size and have adequate flexibility and pressure to securely navigate long lumens and tortuous passages It is preferable. Because long and tortuous passages are obstructed, to deliver an implantable device, both the delivery catheter and the implantable device have the size and shape to provide the required flexibility, pushability and inductivity. It must be.

  In one embodiment, the method according to the present invention includes guiding and positioning a defect closure system having a closure device and at least two anchor structures in the vicinity of the defect in a small diameter transport condition. Generally, the first anchor structure is deployed in contact with the surface in the vicinity of the defect or opening, or installed in the vicinity. By deployment, the first anchor structure opens and expands in the circumferential direction, forming a structure with a perimeter that is greater than the perimeter of the closure structure. The closing structure is arranged and developed over the defect portion and the opening, and covers and closes the defect and the opening. After the closure structure is placed, the second anchor structure is deployed in contact with or near the surface facing the defect or opening. The second anchor structure opens and expands in the circumferential direction, and forms a structure having a peripheral length larger than the peripheral length of the closing structure. The anchor structure in the expanded state is preferably in contact with or located close to the lumen surface or tissue near the defect, and the occlusion structure covers the opening and has a normal structure and shape. Consistent with the structure and shape of the lumen wall or defect that is closed for recovery. The anchor structure acts to contact the surface facing the defect structure, contacts healthy tissue in the vicinity of the defect, and expands to position and hold the occlusion structure in the opening. .

  The placement of the defect occlusion system can also be done by placing a radiopaque marker on the delivery catheter and / or defect occlusion system. One or more radiopaque markers, for example, a first anchor structure, the distal end of the device (in the transport state); an intermediate portion of the device, in the occlusion structure (in the transport state); and / or A second anchor structure can be provided at the proximal end of the device. The device places a distal end radiopaque marker across and in the vicinity of the defect opening and deploys the first anchor structure; places a central radiopaque marker in the defect opening And deploy the occlusion structure; deploying the proximal anchor radiopaque marker slightly outside the opening and deploying the second anchor structure. By using radiopaque markers with respect to the occlusion device and / or delivery catheter, the anchor and occlusion structure can be placed and deployed accurately. The occlusion system is securely held by placing the anchor structure circumferentially on the surface facing the tissue near the opening and placing the occlusion structure in the opening. The position of the occlusion system can be observed by examining the position of the radiopaque marker provided on the device after installation and treatment.

  The implantation device of the present invention employs an occlusion structure to occlude and extend the opening or cavity. The closure structure can be composed of various materials described below. The size and shape of the occlusion structure in the deployed state is preferably at least larger than the defect opening such as the neck of the aneurysm, and preferably covers the opening when the occlusion structure is deployed. The occlusion structure may have a continuously occluded surface area, as another example, to facilitate installation using a guidewire and / or to transport an auxiliary implantable device or a substance. It may have one or more openings for ease.

  The occlusion structure has sufficient radial flexibility in some embodiments to reproduce the structure and motion of the target tissue (eg, pulsatile). When the occlusion structure is placed in the neck of the aneurysm, it follows the movement of the blood vessel while restoring effective vessel wall repair and strength, structure, and flexibility. In a preferred embodiment, after the occlusion structure and / or anchor structure is placed in the vascular defect, it not only repairs the defect but also promotes cell growth, and further converts the occlusion structure into a physiological structure. Incorporation reduces the chance that the structure will return to a defective state.

  The occlusion structure may incorporate a reinforcing structure through the surface region or a portion of the structure. As an example, for example, a flexible flexible sheet material can be applied to a stiff or irregular shaped reinforcing structure. In one embodiment, the closure structure is supported in the vicinity of the periphery by a wire loop or framework structure that provides reinforcement, and additionally or alternatively includes an anchor structure. In one embodiment, the reinforcing structure includes a collar structure integral with or attached to one or more anchor structures.

  In certain embodiments, the anchor structure biases the occlusion structure toward the lumen wall opposite the defect opening. In one embodiment, a plurality of anchor structures are provided to bias the occlusion structure toward the lumen wall opposite the defect opening. In another embodiment, a plurality of anchor structures are provided, at least one anchor structure is in contact with or near the lumen wall near the opening, and at least one anchor structure is defective. It is located in contact with or near the outer lumen wall or inner lumen wall of the section. The anchor structure in one embodiment is located circumferentially inside and outside the defect lumen wall near the opening, and the closure structure is located and covers the opening, effectively from one side of the opening. The other side is shut out, and the inside of the cavity is restored to the original closed structure.

  In one embodiment, the anchor structure is intended to at least partially contact one or both sides of the blood vessel near the opening to support the occlusion structure in the opening. The anchor structure is non-traumatic and supports the occlusion structure without damaging nearby tissue or obstructing blood flow in the blood vessel. In one embodiment, the anchor structure is a loop structure or a clip structure having an opening, and the material density of the surface portion is lower than the density in the surface portion of the closure structure. Implantable devices generally have a small diameter and have a cylindrical shape in the transport state, in which the anchor structure protrudes from the central closure structure in opposite directions. During installation, the anchor structure changes shape and opens outwardly in a circumferential shape, forming a larger diameter anchor structure. As a delivery position, the distal and proximal end anchor structures may be deployed on both sides within the cavity and have approximately the same shape and dimensions. The anchor structure may be composed of different lengths, shapes, and structures. In some embodiments, the anchor structures are located inside and outside the lumen and are aligned with each other, while in other embodiments, they are arranged in a zigzag manner with respect to each other.

  In other embodiments, the implantable device includes an occlusion structure combined with one or more anchor structures and / or collar structures as described above. In this embodiment, the anchor structure includes at least two positioning loops provided in the closure structure. The positioning loop is sized and shaped to contact the aneurysm and / or the inner wall of the blood vessel wall in the vicinity of the aneurysm in the deployed state, and the occlusion structure is placed on the wall of the aneurysm or near the aneurysm neck. It is biased toward the blood vessel wall side and fixed so that the occlusion structure covers the neck of the aneurysm.

  In the deployed state, the occlusion structure and anchor structure can be located inside and / or outside the aneurysm neck. In certain embodiments, for example, the implantable device is positioned inside the aneurysm so that the anchor structure contacts the inner wall of the aneurysm and the occlusion structure covers the aneurysm neck at its periphery. In another embodiment, the implantable device is placed in a blood vessel in the aneurysm so that the anchor structure contacts the vessel wall and the occlusion structure covers the neck of the aneurysm at its periphery. Depending on the shape of the anchor structure, a plurality of anchor loops are provided so as to be in contact with or near the blood vessel wall near the aneurysm after placement.

  In yet another embodiment, the implantable device includes a tapered or conical occlusion structure that couples with the occlusion membrane and an anchor structure having at least two positioning members. In this embodiment, the taper portion of the occlusion structure includes a discontinuous mesh made of a metal material that can be reshaped and expands so that at least a portion contacts the inner wall of the aneurysm during placement. Preferably, the base of the tapered discontinuous mesh structure is coupled to the closure structure. The anchor structure is provided in the occlusion structure and may include a plurality of positioning loops and in contact with at least the blood vessel wall near the aneurysm neck in the deployed state. According to another embodiment, the anchor structure has at least two petal-like structures, for example metal structures with a permeable or non-permeable coating. According to another embodiment, the anchor structure may include a second tapered discontinuous mesh structure having a shallower shape than the occlusion structure.

  The occlusion structure placed in the neck of the aneurysm has a central opening or groove through which another device's guidewire can pass or for subsequent introduction of parts, devices, etc. into the occlusion system May be. According to the method of the present invention, an embolic device such as a coil or a liquid or particulate embolus is injected into the opening of the occlusive structure through the delivery catheter after the occlusive structure is installed. In certain embodiments, the embolic material and / or device biases the periphery of the occlusive device toward the inner wall of the aneurysm, thereby securing the occlusive device at the neck of the aneurysm.

  The implantable devices disclosed herein can be delivered through a delivery catheter to a target location by using a pusher delivery system and / or a release mechanism. The closing structure, the support framework, and the anchor structure are compressed along the transport axis and arranged in a cylindrical shape in the transport state. In embodiments that use a pusher mechanism, the pusher is located in the vicinity of the anchor device and can move the occlusion device relative to the delivery catheter. The device is deployed by pushing the device out of the delivery catheter and pulling the catheter back while keeping the device static. In an alternative embodiment, the implantable device includes a removable element that is detached after being placed. Release mechanisms are well known and mechanical, electrical, hydraulic, and other systems are used to deploy implantable devices.

  In certain deployment systems, device wires are provided in the implantable device of the present invention. The device wire is attached to or near a detachment mechanism that includes a shape deformation activating element that is linear and fixedly coupled at a proximal end, such as a delivery wire or catheter. The proximal end of the device and the distal end of the activation element comprise a mating connection mechanism that is securely connected in the transport state and guides the implantable device to the desired disengagement position. The activation element is detached from the device wire by placing the device at a desired position and then applying a shape deformation force to the activation element by heat, current, or the like, and the shape of the activation element changes to change the device. The wire is released and the activation element and the transport wire can be pulled back.

The expansion front perspective view shown in the state where one example of the implantation type occlusion device was developed. The expansion front perspective view shown in the state where another example of an implantable occlusion device was developed. FIG. 1B is an enlarged view showing the occlusion device shown in FIGS. 1A and 1B applied to an aneurysm. FIG. 1B is an enlarged view showing the occlusion device shown in FIGS. 1A and 1B applied to an aneurysm. FIG. 1B is an enlarged view showing the occlusion device shown in FIGS. 1A and 1B applied to an aneurysm. FIG. 1B is an enlarged view showing the occlusion device shown in FIGS. 1A and 1B applied to an aneurysm. The expansion front perspective view shown in the state where another example of an implantable occlusion device was developed. FIG. 2B is an enlarged front perspective view showing the implantable occlusion device shown in FIG. The expanded front perspective view which shows another Example of an implantable occlusion device in the state which one part developed. The expansion front perspective view shown in the state where all the other examples of the implantable occlusion device were developed. FIG. 4 is an enlarged front perspective view showing the implantable occlusion device shown in FIGS. 3A and 3B inserted into the neck of the aneurysm. FIG. 3B is an enlarged front perspective view showing the implantable occlusion device (broken line) shown in FIG. 3B in a deployed state inside the aneurysm and blood vessel. FIG. 3B is a cross-sectional view showing the implantable occlusion device shown in FIG. 3B in a deployed state inside the aneurysm. An occlusion structure comprising a flexible patch having a plurality of anchor structures around it. FIG. 3 is an enlarged perspective view of an implantable occlusion device having a neck element upright in the deployed state. FIG. 3 is an enlarged perspective view of an implantable occlusion device having a neck element upright in the deployed state. FIG. 3 is an enlarged perspective view of an implantable occlusion device having a neck element upright in the deployed state. FIG. 6 is an enlarged side view of another example of an implantable occlusion device having an occlusion structure coupled with an anchor structure in a transported state. The expanded side view which shows another Example of the implantable occlusion device in this invention in the state which expand | deployed partially. FIG. 6 is an enlarged perspective view showing another embodiment of an implantable occlusion device having anchor struts facing each other in the deployed state. The expansion perspective view which shows another Example of the implantable occlusion device which has a bulbous occlusion member in the unfolded state. The expanded perspective view which shows another Example of the implantable occlusion device which has a coil structure in the expansion | deployment state. The expansion perspective view which shows the Example of the implantable obstruction | occlusion device in this invention in a conveyance state. The expansion perspective view which shows the deployment method useful for installing the device in this invention. The expansion perspective view which shows the deployment method useful for installing the device in this invention. The expansion perspective view which shows the deployment method useful for installing the device in this invention. The expansion perspective view which shows the deployment method useful for installing the device in this invention. The expansion perspective view which shows the deployment method useful for installing the device in this invention.

  The details of the implantable system in the present invention are described and illustrated with respect to application to an aneurysm occlusion device. However, it goes without saying that these systems are not limited to this application and can be applied to the treatment and repair of blood vessels, tissues, bronchial airways, and the like. Similarly, it should be understood that Applicants' method for repairing defects and openings is not limited to the system described herein.

  The implantable occlusion device of the present invention includes an occlusion structure that spans a tissue defect and an anchor structure that secures the occlusion structure in place. A number of alternative embodiments and structures are disclosed herein. The flexible patch or membrane used in the occlusion structure disclosed herein is flexible so that it can be transported through the catheter in a small diameter transport state and into a large dimension when deployed. Made of material. In one embodiment, the occlusion structure is made of an impermeable material that is impermeable to liquids such as blood and body fluids. Alternatively, it may be made of a permeable material through which a liquid such as blood or body fluid passes halfway or through. The occlusion structure can adopt various shapes depending on the application of the device, and generally, a circular shape, an elliptical shape, an oval shape, a polygonal shape, and the like are adopted.

  The closure structure is a biocompatible material and is made of a material that is compressible, foldable, and deformable so as to have a small diameter during transportation. Examples of the material forming the closed structure include various kinds of natural or artificial polymer materials, silicon materials, rubber materials, woven or non-woven fabrics such as Dacron (registered trademark), and Teflon (registered trademark). Fluorine heavy, such as expanded polytetrafluoroethylene copolymer (ePTFE) such as polytetrafluoroethylene copolymer (PTFE), Gore-Tex (registered trademark), soft foam (registered trademark), Impura (registered trademark) There are coalesced compositions, polyurethane materials, polyurethane and silicon compounds and polymers today. In other embodiments, the occlusion structure may include a metal material that is a thin film shape memory alloy, eg, a thin film nickel titanium alloy such as a nitinol alloy. The membrane layer and the membrane contain a plurality of components and are given a composition. In one embodiment, the occlusive structure is flexible in the radial direction, elastic, expandable, and composed of a material according to the movement and pulsatility of the tissue and blood vessel in the place where it is disposed. Is done.

  In one embodiment, the closure structure includes a regular or irregular mesh-like structure on the surface. In general, a mesh-shaped closing structure has a fine mesh structure. The closure structure in one embodiment has a mesh-like structure that is radially expandable. In other embodiments, the closure structure has one or more axially expandable mesh-like structures.

  The occlusion structure may have a porous or perforated surface structure in at least a part of its surface area, and the holes are arranged with a certain porosity or arranged with different porosity depending on the location. ing. The standard hole size may be constant on the surface of the occlusion structure, or holes of various sizes may be placed. Generally, the hole size is preferably about 0.5 to 200 microns. In one embodiment, the perforated structure allows fluid to flow across the occlusion structure, but excludes large proteins and cells including red blood cells. In general, perforations having an average diameter of 10 microns or less exclude large proteins and cells while allowing fluid to flow across the membrane. The arrangement of the perforations forms a regular or irregular pattern, and the shape of the perforations may be regular or irregular, and generally has a circular shape, an elliptical diameter, a quadrangular shape, and the like. For example, the porosity may be high in the periphery of the occlusion structure that is in contact with the tissue or blood vessel wall.

  The occlusion structure may alternatively or additionally be subjected to a surface treatment to promote cell attachment and growth on one or both sides. For example, in one embodiment, the material comprising the occlusion structure has an irregular rough surface that promotes cell attachment. In another embodiment, the occlusion structure has a three-dimensional shape with indentations and grooves incorporated in a regular or irregular pattern to promote cell attachment and endothelial activation.

  In the devices disclosed herein, the occlusion structure and / or other components of the implantable device include one or more anchor structures to promote cell growth and attachment at the deployment site. Has been processed or processed, or contains material. Similarly, the method of the present invention involves injecting a substance that promotes cell growth and endothelial activation at the location where the device is deployed before, during and / or after the implantable device is installed. . For example, in vascular applications, it is desirable to promote endothelial activation of blood vessels where there are aneurysms or other defects that are repaired by the placement of the device of the present invention. Various materials used in the methods and systems of the present invention are described in US Patent Publications 2004/0087988 and 2004/0193206, which are hereby incorporated by reference in their entirety.

  Numerous materials can be administered before, during, after, or in conjunction with an implantable device prior to placement of the device to promote cell growth. Biocompatible materials can be used for this purpose, such as proteins such as collagen, fibrin, fibronectin, antibodies, cytokines, growth factors, enzymes; polysaccharides such as heparin, chondroitin; Poly (alpha.hydroxy acid); RNA; DNA; other nucleic acids; polyesters such as polyglycoids, polylactides and polylactid-co-glycolides; polylactones including polycaptolactone; polydioxanones; Polyamino acids such as polylysine; polycyanoacrylates; poly (phosphazenes); poly (phosphate esters); polyesteramides; polyacetals; polyketals; polycarbonates containing trimethylene carbonate; Polyalkylene succinate; polyalkylene succinate; chitin; chitosan; oxidized cellulose; polyhydroxyalkanoate including polyhydroxybutyric acid, polyhydroxyvaleric acid and copolymers thereof; polymers and copolymers of polyethylene oxide; Polyethylene acrylate; polyamide; polyethylene; polyacrylonitrile; polyphosphazene; poly (amide anhydride), poly (amide ester) anhydride, aromatic fatty acid anhydride, aromatic anhydride, poly (ester anhydride), fatty acid anhydride Acid anhydrides consisting of dicarboxylic acid monomers including: other biocompatible polymers, copolymers and terpolymers; bioactive residue materials; these compounds.

  Some biocompatible polymers have sufficient bioabsorbability, including polylactide, polyglycoid, polylactideglycoid, acid anhydride, poly p-dioxane, trimethylene carbonate, polycaprolactone, polyhydroxyalkanoate, etc. Suitable for use with the devices and methods of the present invention. The biocompatible polymers included below, which are generally considered not to have sufficient bioabsorbability, can also be used. Polyacrylates; Ethylene vinyl acetate; Cellulose and cellulose derivatives including cellulose acetate and cellulose acetate propionate; Non-erodible polyolefins; Polystyrene; Polyvinyl chloride; Vinyl fluoride resin; Polyvinyl (imidazole); Polyethylene oxide; polyethylene glycol; polyvinyl pyrrolidone; polyurethane; polysiloxane; copolymers and terpolymers thereof; Other exemplary polymers have been widened and it will be readily apparent to those skilled in the art that there are so many such polymers that they cannot be listed here. Accordingly, this list is provided for purposes of illustration and is not exhaustive.

  Non-polymeric materials can also be used in the occlusion system in the present invention. Preferred non-polymeric materials include, for example, hormone substances and anti-neoplastic substances. Examples of other biocompatible materials that promote integration with blood vessels include, for example, human or animal tissue treated with cells or cell debris, artificial vascular tissue, bladder / stomach / liver matrix material, natural or Contains artificial genetic material.

  Other types of compositions can also be used in the occlusive structure or anchor structure that constitutes the occlusive device in the present invention. Hydrophilic substances and / or hydrophobic substances or adhesives can be used, for example, in all or some structures. Similarly, lubricants including fluoropolymers such as PTFE can be used on all or some structures to facilitate deployment from the delivery catheter. A radiopaque marker or radiopaque material is provided on a specific structure or part of the device structure to enable accurate positioning, placement, and monitoring of the deployed device. For example, in certain embodiments, the radiopaque material can be provided integrally with the occlusion structure or coated over the occlusion structure. In other embodiments, certain therapeutic agents, antibiotics, thrombogenic substances, non-thrombogenic substances, etc. may be provided on a specific structure or part of the device structure, or before or during the deployment of the implantable device. It may be administered later. Suitable materials are widely known and are used with other types of implantable devices.

  The occlusion structure includes a plurality of layers, and various types of coatings, adhesion / adhesive substances and therapeutic agents, hydrophilic substances or hydrophobic substances, swellable materials such as hydrogels, radiopaque materials, etc. Can be used. In certain embodiments, the swellable hydrogel, when used on the surface of the occlusion structure and / or the surface of the anchor structure, contacts the aneurysm inner wall in the deployed state. In another embodiment, if a substance or compound of substance that promotes embolism is used on the surface of the occlusion structure and / or the surface of the anchor structure, in contact with the inner wall of the aneurysm in the deployed state, The embolization of the aneurysm is advanced. In yet another embodiment, a substance or compound of a substance that acts to reduce thrombosis and blood clotting, such as heparin, plasminogen activator (tPA), and the surface of the occlusive structure and / or the vessel wall Used on the surface. In another embodiment, a substance that prevents restenosis and / or a substance or substance that reduces inflammation, such as paclitaxel and its derivatives, sirolimus, steroids, statins, ibuprofen, and other anti-inflammatory substances is occluded. Used on the surface of the structure and / or the surface of the anchor structure. In another embodiment, radioactive material is used on the surface of the occlusion structure and / or the surface of the anchor structure for therapeutic or imaging purposes.

  The membrane forming the occlusion structure has a continuous surface area and is provided with one or more openings or grooves that facilitate installation into an implantable device in a set-up or transfer state. The membrane is secured to a framework or anchor structure that includes a shape-changeable material such as a shape memory alloy. Some membrane materials can also be applied to frameworks or anchor structures by methods such as coating or dip coating.

  The composition of the framework, such as an anchor structure or reinforcement structure that supports the occlusion structure, is made of a biocompatible shape changeable material such as a shape memory alloy that exhibits superelastic and / or shape memory properties. The shape-deformable material changes its shape into a predetermined form when a shape-deformation force is applied by heat, electric current, or the like, and deforms into a predetermined deployment state. The force that changes the shape is caused by a change in the generated temperature, for example, placing the device under a body temperature environment, applying heat to the device using an external device, or applying heat to the device using an electric current. Caused by. By warming the shape memory material, the material changes as described above, and the framework structure and / or anchor structure of the device changes to a predetermined large size and shape.

  Nitinol alloys that exhibit superelastic and shape memory properties are preferred shape memory alloys for use in the devices of the present invention. The framework and the anchor structure can be formed of, for example, a rigid wire, a tubular wire, or a braided material, and are cut from a tubular or cylindrical structure. The framework and anchor structure may contain other additional materials and may have a coating or member between the framework structures. In one embodiment, the framework and anchor structure is made of a thin film shape memory alloy, such as a Nitinol thin film alloy, using well known sputtering techniques.

  Implantable devices can be delivered to their destination by using a delivery catheter with a pusher or rod, or a special microcatheter (referred to as a “delivery catheter”), or by using a pusher system with a release mechanism. The For example, in one embodiment, the occlusion structure is removably provided in a low position at the distal end of the delivery catheter, and is covered and held in a low position by a retractable sheath. The delivery catheter is positioned in the neck of the aneurysm by known techniques, and when the sheath is retracted, the occlusion device deploys to a predetermined shape and closes the neck of the aneurysm. More particularly, in the first step of retracting the sheath, the first anchor structure is deployed and is in contact with or located near tissue in the vicinity of the aneurysm neck; in the second step, the occlusion structure The body or membranous occludes the neck of the aneurysm and the second anchor structure is deployed and is in contact with or located near the tissue near the aneurysm neck.

  FIG. 1 shows an embodiment of an occlusion device 30 having a patch, ie an occlusion structure 31, provided on two anchor structures 32, 33. Preferred materials for forming the occlusion structure or membrane are as described above. The closing structure 31 is supported by a framework structure 34. The framework structure 34 is attached to the closing structure 31 at least at a part around the closing structure 31 in a manner such as adhesion or stitching. Yes. The framework structure 34 is provided on the wing-like anchor structures 32 and 33. Both the framework structure 34 and the anchor structures 32 and 33 are preferably formed of a shape-changeable material such as a nitinol alloy.

  The anchor structures 32 and 33 may be formed of a material composed of a high-rigidity wire, that is, a tubular structure, or a braided structure or other mesh structure. In the installed state, the anchor structures 32 and 33 are shaped such that at least a part of the anchor structures 32 and 33 is in contact with the inner wall of the aneurysm or the inner wall of the blood vessel. The shapes of the anchor structures 32 and 33 may be circular, elliptical, or other curved structures, and may be polygonal. In a preferred embodiment, as shown in FIG. 1A, the anchor structures 32 and 33 are curved outwardly from the joint portion 35 to the framework structure 34 and are inwardly of the joint portion 35 at the ends. An elliptic curve shape is formed so as to face each other.

  In the embodiment shown in FIG. 1A, the anchor loops 32, 33 are generally of the same shape, are of the same dimensions, and are mounted at opposite positions. As another example, anchor structures having different structures and / or dimensions may be used. For example, one anchor structure may be longer and / or wider than the other, or may have a three-dimensional curved structure or a polyhedral shape different from each other. Although two anchor structures 32, 33 are shown in the figure, additional anchor structures may be added. In this case, it is preferable that the framework structure 34 and / or the closing structure 31 be attached symmetrically.

  FIG. 1B shows a similar occlusion device, which is an occlusion structure 36 having anchor structures 37, 38 provided facing the side edges of the framework structure 39. You may provide an opening part or a groove part in the substantially center part of the closure structure 36. FIG. The anchor structures 37, 38 are generally curved, as shown in FIG. 1B, with their ends extending beyond the ends of the corresponding framework structure and occlusion structure. The occlusion structure and the framework structure in the present embodiment have a surface wider than the neck of the aneurysm, and the anchor structure is installed in the arrangement shape described below inside the aneurysm. Due to this shape, lateral and downward forces are generated in the occlusion structure, so that it matches the side of the aneurysm vessel lumen and seals the neck of the aneurysm from the bloodstream to repair the vessel.

  FIGS. 1C-1F are schematic representations of the occlusion device shown in FIGS. 1A and 1B placed in an aneurysm. The raised portion of the blood vessel B forms an aneurysm A. As shown in FIGS. 1C and 1D, the occlusion device 30 is placed over the neck and within the aneurysm, and the occlusion structure 31 covers the anchor structure 32, so as to cover the aneurysm opening. 33 is arranged inside the aneurysm so that at least a part of its surface is in contact with the inner wall of the aneurysm. In this embodiment, the occlusion structure 31 and the support portion 34 are supported by the opening of the aneurysm and are located on the outer side of the aneurysm. In the embodiment shown in FIGS. 1C and 1D, the occlusion structure 31 and the support 34 are located outside the aneurysm. FIG. 1E shows another embodiment in which the occlusion structure 31 and the support 34 are supported by the opening of the aneurysm and are located on the inner side of the aneurysm.

  FIG. 1F shows another deployment system and method in which an occlusive device having at least two anchor structures has anchor structures 32, 33 of the aneurysm such that the occlusive structure 31 covers the aneurysm opening. It is located outside and is arranged so as to be in contact with the blood vessel inner wall in the vicinity of the aneurysm. In the present embodiment, the anchor structures 32 and 33 have the same size and shape as the inner diameter of the blood vessel near the neck of the aneurysm, so that the anchor structure damages or expands the blood vessel having the aneurysm. Without contact, the inner wall of the blood vessel can be contacted in a continuous manner. In these embodiments, the occlusion structure covers the aneurysm neck to efficiently treat vascular defects, and the anchor structure does not impede blood flow.

  FIG. 2A shows another occlusion device 40 that is supported by a framework structure 42 and has an occlusion structure 41 provided on anchor structures 43, 44, 45, 46. The characteristics and shape of the closing structure 41 are as described above. The closing structure 41 is supported by the framework structure 42. The framework structure 41 is attached to the closing structure 41 at least in a part around the closing structure 41 in a manner such as adhesion or stitching. Yes. The framework structure 42 is provided on the pair of wing anchor structures 43 and 44 and 45 and 46. The framework structure 42 and the anchor structures 43, 44, 45, 46 are all preferably made of a shape-changeable material such as a nitinol alloy.

  The anchor structures 43, 44, 45, 46 are designed so that at least a part of the anchor structures 43, 44, 45, 46 is in contact with the inner wall of the aneurysm or the inner wall of the blood vessel in the installed state. The shape in which the anchor structures 43, 44, 45, and 46 are installed may be circular, elliptical, or other curved shape, or may be a polygonal shape. In a preferred embodiment, as shown in FIG. 2A, the anchor structures 43, 44, 45, 46 are curved outwardly from the connection with the framework structure 42, with a frame at the outer end. A substantially elliptic curve shape is formed so as to make a difference inward from the work structure 42. In the embodiment shown in FIG. 2A, the anchor loops 43, 44, 45, 46 have substantially the same shape and dimensions. The anchor loops 43 and 46 are in a positional relationship that forms a mirror image with respect to the anchor loops 44 and 45. Similarly, the anchor loops 43 and 44 are in a positional relationship that forms a mirror image with respect to the anchor loops 46 and 45. As another example, the shape and / or dimension of each of the anchor loops 43, 44, 45, 46 may be changed or different. Although two pairs of anchor structures are shown here, additional anchor structures, i.e. pairs of anchor structures, may be provided. The anchor structure is preferably mounted to be targeted with respect to the framework structure 42 and / or the occlusion structure 41.

  FIG. 2B shows an occlusion device of the type shown in FIG. 2A in which the patch 41 covers the aneurysm opening while two anchor structures are placed inside the aneurysm and in contact with at least a portion of the aneurysm inner wall. It is a figure shown in the state arrange | positioned in the state which two anchor structures arrange | positioned on the outer side of an aneurysm contacted the blood vessel inner wall near the aneurysm. In a method of treating a blood vessel using an occlusive device of the type shown in FIG. 2A, a first anchor structure, for example, anchor loops 43 and 46 inside an aneurysm A are connected to the inner wall of the aneurysm near the aneurysm internal neck. The occlusion structure 41 over the neck of the aneurysm and over the neck, and a second anchor structure, for example anchor loops 44, 45 outside the aneurysm neck, It arrange | positions so that the blood vessel inner wall near the aneurysm neck may be contacted.

  For another example of an aneurysm occlusion device, FIG. 3A shows a partially expanded state and FIG. 3B shows a fully expanded state. In this embodiment, the occlusion device 50 has a tapered occlusion structure in which a conical tip is cut off to a membranen 52 having the above occlusion structure and a plurality of positioning members 53, 54, 55, 56. It has a body 51.

  The tapered occlusion structure 51 is preferably a porous structure, such as a mesh made of a metal material that can be reshaped, and is thin when transported to form a small-diameter structure. Touch the inner wall of the. The porous or mesh-like structure has a large and small space in the structure, and the space and the structure may be symmetrical or asymmetrical and may be curved, linear, or angular. . As the structure such as the expandable mesh, a well-known one, for example, various types of stents can be adopted. The tapered occlusion structure 51 may be covered at least partly with elastic fibers, biocompatible membrane materials such as silicon material, PFTE material, Dacron (registered trademark), or fibrous materials. .

  The tapered closing structure 51 is connected to or provided to the closing membrane 52 at the small diameter base portion 57. The peripheral length of the closing structure 51 may be made equal to the diameter of the small diameter base portion 57 or may be larger than the diameter of the small diameter base portion 57. For example, the closing structure 51 is provided in the vicinity of the framework structure 58, and the small-diameter base portion 57 is provided on the inner periphery of the framework structure 58.

  A loop structure similar to the anchor structure described above can be employed for the positioning members 53, 54, 55 and 56 of the occlusion device 50. Alternatively, the positioning member may be formed of a hard metal structure, a discontinuous mesh, or a flexible material. Two or more members are arranged so as to be symmetrical with respect to the closing structure 51 in the radial direction. As another example, a non-continuous mesh structure having a tapered shape which is shallower than the tapered closing structure 51 can be provided as the anchor structure.

  FIGS. 4A to 4C are views showing a state in which the occlusion device 50 is placed during or after placement inside the aneurysm or after placement. FIG. 4A shows the occlusion device 50 with a portion inserted into the aneurysm A. FIG. The tapered occlusion structure 51 is installed as a first anchor structure through the neck of the aneurysm and is disposed with the membrane 52 in the aneurysm. The membrane 52 extends over the neck of the aneurysm and substantially occludes the neck. Positioning members 53, 54, 55 and 56 are placed outside the aneurysm neck after placement and contact the inner wall of the blood vessel near the aneurysm neck. By installing the occlusion device in this way, the inner wall of the blood vessel is treated and restored to normal health.

  FIG. 5 shows another embodiment of the implantable device 60, wherein the flexible closure structure 61 has a plurality of anchor members 62 attached in the vicinity of or around the closure structure. The anchor member 62 has at least two spaced-apart arms 63 and 64 as shown in the figure, and is attached to the inner surface or the outer surface of the closing structure 61, or the facing arms 63 and 64 are opposite to the closing structure 61. It is attached in a state of extending from the side surface and penetrating the closing structure 61. The arms 63 and 64 are located on the closing structure, but the outer edge portion 65 of the closing structure 61 is disposed outside the connecting portion between the arms 63 and 64 and the closing structure 61.

  The implantable device 60 is radially foldable or compressible to achieve minimally invasive delivery through the catheter device. Since the device moves in a small diameter cylindrical shape in the transport state, the arms 63 and 64 are substantially linear. After transporting the device to the desired position, one of the arms in the transported state is expanded and deployed to the aneurysm inner wall near the neck. The remaining arms are arranged such that a series of arms face each other in a three-dimensional space, and the second arm group is arranged on the blood vessel inner wall near the neck. The occlusion structure 61 is located over the entire aneurysm so as to cover the neck opening of the aneurysm when each anchor arm is in a deployed state. When the implantable device 60 is placed in the neck of the aneurysm, the occlusion structure 61 covers the neck and the arms 63, 64 form a fixation point within the aneurysm and within the blood vessel. The outer edge portion 65 has a larger diameter cross-section than that of the occlusion structure 61, and additionally forms a further coating on the aneurysm neck and / or the blood vessel inner wall near the neck.

  6A-6C show another embodiment of an occlusive device. The closure system 70 includes a central closure structure 71 with a reinforced neck structure 72 and a plurality of anchor structures 73, 74, as shown in FIG. 6A. The closing structure 71 may optionally be provided with an opening or groove in the central region. The reinforced neck structure 72 can be attached to the peripheral portion of the closing structure 71 integrally with the closing structure 71 or as a separate body. The neck structure 72 includes a reinforcing member 75 and a flexible membrane member. By combining these, the reinforced neck structure has an upright collar structure with a cylindrical shape, egg shape, or similar shape, which is placed on the neck of the aneurysm and then protrudes into the aneurysm Then, the neck is sealed and separated from the blood vessel. The reinforcing member 75 can be defined by a zigzag pattern as shown in the figure, or can be defined by another pattern that supports an upright neck structure on the structure. The reinforced neck structure 72 is drawn in a direction that protrudes perpendicularly from the plane of the occlusion structure 71, but depending on the desired application and the tissue shape of the body to be occluded, the reinforced neck structure 72 may be It is preferable to project at an acute angle or an obtuse angle with respect to the surface 71.

  The closure system 70 includes a skirt 76 that extends from the closure structure 71 or neck structure 72 and has a larger diameter than the closure structure 71 or neck structure 72. The bottom part closes the opening to be closed over a wider area, and is located outside the opening part. For example, in the case of an aneurysm, it contacts the blood vessel wall near the neck of the aneurysm. It is particularly preferable to use a device including a skirt when the shape of the opening is irregular, and the dimension of the skirt is adjusted along the opening. The hem preferably has a diameter that expands at least 10% when deployed. More preferred is 15%, and in some embodiments 20%. In still another embodiment, it is preferable that the diameter of the skirt in the expanded state is extended by at least 30%.

  The anchor structures 73 and 74 are preferably formed of a hard material, and are preferably formed of a shape memory material such as a nitinol alloy. In the embodiment shown in FIG. 6A, the anchor structures 73 and 74 protrude in the directions of both sides with respect to the surface of the closing structure 71, and are joined by a structure support intermediate 77. The anchor structure may be formed integrally and may be a single body, or may be separated and separated. The anchor structures 73 and 74 have a triangular shape with rounded corners as shown in FIG. 6A. In another embodiment of the occlusion structure 78 shown in FIG. 6B, the anchor structure is a more rounded paper clip-like structure. The anchor structure can take a variety of sizes, shapes and widths. Depending on the intended use, the anchor structure can be a mesh-like or porous shape. In the figure, three sets of anchor structures are shown. Of course, the number of the anchor structures may be larger or smaller than this, and they are radially arranged so as to be symmetrical with respect to the central patch.

  FIG. 6C shows an occlusion structure 80 of similar structure, including a central occlusion structure 81 with a cylindrical collar region portion 82 and a flare skirt portion 83. A boundary portion between the collar region portion 82 and the flare bottom portion 83 is continuous in a curved line. Reinforcement is made by anchor arms 84, 85 facing in opposite directions, which are alternately twisted and arranged radially.

  FIG. 7A is a diagram showing an occlusive device 120 according to another embodiment of the present invention in a small diameter conveyance state, and FIG. 7B is a diagram showing an alternative occluding device 130 in a large diameter deployed state. The occlusion device 120 includes first and second anchor structures 122, 124 that protrude in an opposite direction from the intermediate collar structure 126 and extend laterally of the occlusion structure 128. The anchor structures 122 and 124 are made of a material whose shape can be changed, and have a cylindrical shape as a whole in the transport state shown in FIG. 7A. When deployed, the anchor structure (124, 126) bends outward significantly to form a substantially circular ring-like structure in the deployed state.

  The anchor structures 122 and 124 are preferably substantially free of tissue damage in the deployed state and minimize trauma to the tissue. In one embodiment, anchor structures 122 and 124 have a generally flat structure, cross-sectional shape. In the embodiment shown in FIG. 7A, the anchor structures (122, 124) have substantially the same shape and dimensions, project from both sides of the intermediate collar structure, and have a zigzag or offset shape. In the deployed state, anchor structures 122 and 124 come into contact with non-overlapping portions of tissue facing the occluded defect. This arrangement provides little trauma and can promote and maintain tissue viability and blood flow in the area where the occlusion device abuts. Inflated distal and proximal pads 123 and 125 are provided on anchor structures 122 and 124, respectively, to place and deploy the occlusion device and provide a greater contact diameter in the area where it adheres to the tissue. growing.

  In the figure, the anchor structures 122 and 124 are depicted as flat wire structures having a generally triangular shape, and the overall length is longer than the intermediate collar structure, but other shapes can of course be employed. . It is also possible to add a reinforcing structure or a pressure distribution structure to the surface. Alternatively, or additionally, at least one anchor structure may be provided with a membrane forming an occluding structure.

  At least one or more radiopaque markers are preferably provided in the vicinity of the end of the anchor structure 122, 124 away from the intermediate collar structure, i.e. in the deployed state of the implantable device. Hit the distal and distal ends. For example, pads 123 and 125 contain or consist of radiopaque markers, and mark the distal end of the anchor structure during or after installation. As the radiopaque material, tantalum, gold, silver, barium, platinum, tungsten and the like are preferable. The radiopaque marker can be bonded to the anchor structure by, for example, glue adhesion, adhesion, pressure bonding, welding, laser welding, or the like.

  The intermediate collar structure 126 includes a cylindrical reinforcing structure composed of ribs 127, and this reinforcing structure has a higher density than the anchor structure. Ribs 127 are coupled to the flexible membrane structure and, in this example, span substantially the entire range of the collar structure. The membrane structure extends in the lateral direction of the closure structure 128. Radiopaque markers are preferably provided on the collar structure 126 and / or the occlusion structure 128.

  FIG. 7B shows a part of another occlusion device 130 according to the present invention partially expanded. The occlusion device 130 includes first and second anchor structures 132, 134 that project from both sides of the intermediate collar structure 136 and from the sides of the occlusion structure 138. The anchor structures 132 and 134 are made of a material whose shape can be changed. As shown in FIG. 7A, the anchor structures 132 and 134 have a substantially cylindrical shape in the transport state, and the structure is changed during the arrangement, as shown in FIG. 7B. A larger diameter structure with anchor structures 132,134. The unfolded state of the anchor structures 132, 134 is as shown in FIG. 7B, and is recessed toward the center line of the device depending on the type and structure of the defect repaired by the implantable device. Similarly, the center collar structure 136 has a substantially upright cylindrical shape in a deployed state as shown in FIG. 7B and is curved outwardly of the circumference. The device is fixed to the organization. Depending on the size of the defect and the type and thickness of the repaired tissue, the device has various curved shapes.

  Anchor structures 132, 134 are preferably configured to be substantially atraumatic or minimally traumatic to the contacting tissue when deployed. In one embodiment, anchor structures 132 and 134 are generally cylindrical or tubular structures and have a cross-sectional shape. As shown in FIG. 7B, the partially converted anchor structures 132 and 134 protrude from both sides of the central collar structure 136, and in a state where the anchor structure is deployed at the target portion, the anchor structure is a defect portion. It is arranged so as to come into contact with neighboring tissue surfaces facing each other. The distal end of the anchor structure forms a large surface area, and the terminal end is obtuse, so that it makes good contact with the tissue and hardly traumas the tissue that the occlusion device contacts.

  The anchor structures 132, 134 are depicted as triangular flat wire structures, and the overall length is longer than the intermediate collar structure, but it will be appreciated that other shapes may be employed. The anchor structure may further have a structure for dispersing reinforcement or pressure on the surface thereof. Alternatively, or additionally, one or more anchor structures may be provided with a membrane that constitutes the occlusion structure.

  Preferably, at least one or more radiopaque markers are provided near the end of the anchor structure 132, 134 away from the intermediate collar structure, i.e., in the deployed state of the implantable device. Hit the distal and distal ends. The radiopaque marker can be provided, for example, by coupling a radiopaque material to the anchor structure. As the radiopaque material, tantalum, gold, silver, barium, platinum, tungsten and the like are preferable. The radiopaque marker can be bonded to the anchor structure by, for example, glue adhesion, adhesion, pressure bonding, welding, laser welding, or the like. Bands 133 and 135 contain, or consist of, a radiopaque marker to mark the distal end of the anchor structure during or after installation.

  The intermediate collar structure 136 includes a cylindrical reinforcing structure including ribs 137, and the reinforcing structure has a higher density than the anchor structures 132 and 134. The ribs 137 form a cross-shaped structure, are joined to a flexible membrane structure, and have the same extent as the collar structure. The collar structure has an upright cylindrical shape in the unfolded state, and the collar structure and the rib form a circumferential structure curved outward. The lateral occlusion structure 138 is provided or coupled to the intermediate collar structure 136 and / or the membrane structure attached to the collar structure and provides a groove or hole for the passage of a guide wire or other device. May be. One or more radiopaque markers are preferably provided on the collar structure 136 and / or the lateral occlusion structure 138.

  FIG. 8 shows another embodiment of an occlusion device 90, in which an inflated occlusion device 91 comprises an occlusion surface at the center and a substrate connected to a reinforcing structure. The substrate has a plurality of anchor column bodies 92 and 93, and the anchor column bodies 92 and 93 facing each other have a hoof-like pattern like a petal in a symmetrical shape. The struts 92 and 93 are connected to each other by an intermediate structure 94. The reinforcing structure may be configured as a single unit or may be configured by connecting a plurality of independent structures.

  When the device 90 is deployed after being delivered to the neck of the opening in a small diameter delivery state, the anchor strut 92 is first deployed inside the opening and positioned in contact with or near the inner wall of the aneurysm, The intermediate body 94 is located at the neck of the opening. In the deployment process, the anchor strut 93 is in contact with the inner wall of the blood vessel near the aneurysm opening after being deployed, so that the occlusion device 91 is pressed toward the blood vessel in the opening. The closing device 91 in the present embodiment can close the opening having an irregular shape.

  FIG. 9 shows an occlusion device 100 which is still another embodiment in an expanded state. The occlusion device 100 includes a curved conical or bulbous structure 101, which consists of a shape memory alloy on a thin film, such as Nitinol. The end of the curved structure 101 with a small diameter is closed (not shown), and the end with a large diameter has an opening. In the embodiment shown in FIG. 9, the bending structure 101 includes a plurality of membrane panels reinforced by a membrane wall 102, that is, a plurality of ribs 103. The ribs 103 are arranged in a radially symmetrical shape, and the number can be increased or decreased. As another example, the membrane wall 102 may be reinforced with a mesh-like structure or another type of framework structure.

  The occlusion device 100 further includes at least one securing structure 104 for positioning the device 100 and securing it to the opening. The fixed structure 104 may have a curved or coiled band shape, or may have a petal shape or a loop-like structure, and various fixed structures 104 can be employed. When the device 100 is deployed, the bulbous structure 101 is arranged to expand inside the opening, and the fixation structure 104 is arranged outside the opening neck, by contacting the inner wall near the opening. The device 100 is fixed to the opening.

  FIG. 10 shows another embodiment of a spiral shaped occlusion device 110. The framework structure is attached to the inner boundary or the outer boundary of the spiral structure, and the membrane is provided on or integrally attached to the framework structure. In some embodiments, the spiral structure may have a small diameter and a large diameter. As another example, the occlusion device 110 has opposing double spiral coil shapes. In this embodiment, the opposed coils include two coils that are joined at the center of a small diameter and that extend in opposite directions.

  The coil reinforcing structure may be formed of a nitinol wire or a biocompatible and similar shape deformable material, and may be embedded in or provided in a membrane material forming an occluding structure. The membrane has a dimension capable of overlapping the loop of the membrane attached to the coil reinforcing structure, and has an overlapping boundary portion when wound in a coil shape. The occlusion device 110 is deployed such that the end, i.e. the end of the large diameter coil, is located inside the opening to be occluded and the spiral shape tightens the opening. The small diameter portion where the opposing coil structures are joined is located over the opening neck and expands in the outer region of the opening to contact the inner wall of the structure (such as the blood vessel inner wall) near the opening.

  As noted above, the occlusion structures and membranes used in the occlusion system disclosed herein can be formed from thin film shape memory alloys, such as thin film nitinol alloys. The thin-film Nitinol alloy used in the membranes and closure structures in the present invention has a thickness of about 0.5-100 microns, more preferably about 2-50 microns, and 45-55%. Each of titanium and nickel may be included.

  The thin film nitinol alloy is manufactured using sputtering techniques, the disclosure of which is omitted by reference as a whole, for example as disclosed in US Pat. No. 6,533,905. Such a technique uses a mandrel made of iron, glass, silicon or the like having an exposed outer layer on a sputter deposited thin layer of Nitinol alloy. After sputter deposition, the Nitinol alloy thin film formed on the mandrel is subjected to an annealing, and the resulting thin film is peeled off by, for example, immersing the mandrel and the thin film formed on the mandrel in an etching solution. By forming a resist layer containing pore patterns on the annealed thin film, exposing the thin film to create perforations corresponding to the pore patterns, and removing the resist layer, the perforations, small holes, and pores become Nitinol. Sometimes formed on a thin film of alloy. Since the structural member is installed prior to sputter deposition of the Nitinol alloy, the thin film is directly attached to the structural member.

  The framework, support member, and anchor member used in the occlusion device are cut or etched from a tube or cylinder made of a shape memory alloy thin film such as a titanium nickel alloy thin film (eg, Nitinol alloy). Techniques for etching shape memory alloy thin films are widely known. One example is described, for example, by Gupta et al. (SMST-2003: Proc. Intl. Conf. Shape Memory Superelastic Technol., (Pacific Grove, CA) eds. AR Pelton & T. Duerig, p. 639, 2003). Thus, a thin-walled tube is manufactured. Briefly, multiple layers of nitinol alloy and sacrificial material (such as chromium) are continuously sputter deposited onto a flat substrate surface such as a polished oxide silicon wafer. The silicon wafer includes a first vapor-deposited layer made of chromium, and a second vapor-deposited layer made of Nitinol alloy deposited thereafter and two vapor-deposited layers separated from each other. The thickness of the Nitinol alloy layer can be 1 to 40 microns, and the thickness of the chromium layer can be 500 angstroms. Two photomask plates (mask 1 and mask 2) are used, and these masks are transferred with a predetermined pattern for determining the size and shape of the resultant product, in this case, a cylinder or a tube. The mask 1 includes a pattern shape composed of a second chromium layer on the wafer, and the mask 2 includes a pattern shape of a nitinol alloy layer. Standard MEMS techniques are used to pattern Nitinol alloy and chromium layer thin films. After depositing a thin film of Nitinol alloy and a chromium layer on a wafer, a thin film structure having a plurality of layers is formed by dipping in a chromium etching solution and peeling the chromium layer to form a pocket between the first and second Nitinol alloy layers The body is removed from the wafer. The separated thin film structure is transformed into a three-dimensional cylinder by inserting a mandrel made of, for example, stainless steel into a pocket formed between two Nitinol alloy layers and heating in a vacuum at 500 ° C. By using standard photographic techniques, it is possible to form perforations of the desired size, shape and pattern in the Nitinol alloy layer.

  The implantable system disclosed herein also includes an occlusion device with a device wire that removably connects the implantable device to the transport / push wire by a detachment joint. The device wire is provided at the distal end as an integral or ancillary with the implantable device via a detachment joint and is used to deliver the implantable device to a desired position in the body by guiding the guide catheter Is done. Preferred device wires, release joints and transfer / push wires are well known and can also be used in the closure device of the present invention. Materials used for devices and device wires are also well known.

  The occlusion system in the present invention is used to treat defects in blood vessels such as aneurysms, physiological defects, and defects in lumens and tissue cavities. The methods and systems in the present invention allow for the treatment and restoration of lumen walls and tissue defects by using minimally invasive lumen technology without invasive surgical procedures. The transport and placement procedure is easier and less time consuming than other alternatives and can consequently reduce the risk of complications.

  FIG. 11 is a view showing the implantable device according to the present invention attached to a delivery catheter for guiding and placing it in a treatment section, and FIGS. 12A to 12E are diagrams showing examples of delivery and placement methods. . The delivery system 140 includes a delivery catheter 142 with appropriate dimensions, flexibility and pressing force to guide to a target portion such as an aneurysm or a lumen formed in a blood vessel. When it is necessary to guide to a small lumen or a complicated passage, such as a neurovascular aneurysm, the delivery catheter 142 is provided with a microcatheter having a small diameter and high flexibility. May be. The distal end of the delivery catheter is more flexible, eg, more flexible than the proximal end. Various delivery catheters are known and suitable for use in the delivery system of the present invention.

  A small diameter delivery condition at the distal end 141 of the delivery catheter 142, which may be either a repair device, a repair device with two opposing anchor structures disclosed herein, and / or an occlusion device It is preferable that it is attached in advance. The distal end 145 of the repair device 144 delivered through the delivery catheter 142 is preferably an anchor structure located in the aneurysm or lumen, on the lumen wall opposite the inner wall of the delivery path. One or more radiopaque markers 146 may be provided at or near the distal end 145 of the repair device 144. The proximal end 147 of the repair device 144 delivered in the delivery catheter 142 is an anchor located on the vessel wall near the aneurysm or the neck in the lumen, the lumen wall facing the inner wall of the delivery path A structure is preferred. One or more radiopaque markers 148 may be provided at or near the proximal end 147 of the repair device 144. The repair device 144 may additionally or alternatively incorporate a radiopaque marker at the proximal end of the central portion of the device that corresponds to the occlusion structure 149. Radiopaque markers may be additionally or alternatively provided with respect to delivery catheter 142 to mark the distal and proximal ends of repair device 144, respectively.

  The delivery system shown in FIGS. 11 and 12A-E includes a guide wire 150 for guiding and positioning the repair device 144 and a lumen for the guide wire, and contacts the proximal end 147 of the repair device 144 And a pusher 152 that separates from the delivery catheter 142 is used. Preferred guidewires and pushers are well known and are suitable for use in the repair and occlusion devices of the present invention.

  In a method for repairing a physiological defect, i.e., closing an opening or lumen 160, the repair device 144 is transported through a small diameter to the intended repair site through the guide wire 150 and non-invasive or Using minimally invasive techniques, the distal end of the repair device 144 corresponding to the first anchor structure is positioned and guided in the repair opening shown in FIG. 12A. Alternatively, the repair device 144 may be positioned at the aneurysm or defect 160 in the blood vessel 170 by a radiopaque marker provided on the intermediate collar structure or occlusion structure 149. A first anchor structure including a series of anchor arms 145 pushes the distal end of the repair device 144 from the delivery catheter 142 and / or the first anchor structure as shown in FIG. 12B. The delivery catheter 142 is deployed by pulling it back to position it in contact with the inner wall of the nearby aneurysm. Upon deployment, the first anchor arm 145 opens and expands in the circumferential direction, and the anchor structure is in contact with or near the surface of the defect, or is placed and positioned for accurate and intact alignment. During, the radiopaque marker 146 provided on the first anchor structure may be monitored.

  After placing the first anchor structure, the middle portion of the repair device with the closure structure 149 is deployed over the opening to be repaired to close the defect opening as illustrated in FIG. 12C. . The expansion of the intermediate closing structure 149 causes the closing structure to open and spread so as to cover the opening. In this state, the first anchor arm 145 contacts or is in the vicinity of one side surface of the inner wall of the aneurysm, and the occlusion structure 149 covers the lumen opening. Thereafter, the proximal end of the repair device including the second anchor structure 147 and the radiopaque marker 148 provided thereto is pushed out of the delivery catheter 142 or pulled back against the occlusion device. As a result, it is expanded as shown in FIG. 12D. As the second anchor structure is deployed, the anchor arm 147 opens and spreads outward, and comes into contact with the surface of the defect portion, which is a boundary with the portion forming the conveyance path, or in the vicinity of the surface of the defect portion. To position. At this point, the occlusion device 144 is securely fastened and the guidewire 150 is pulled back into the delivery catheter 142. As shown in FIG. 12E, the delivery system 140 is withdrawn and the occlusion device repairs the opening.

  According to the method and system of the present invention, the defect structure and the opening on the body are attached to the cavity or the tissue on both sides of the tissue in the vicinity of the defect by attaching the occlusion structure so as to cover the opening. It is possible to effectively repair the occlusion structure provided with the above by supporting and fixing it at a position beyond the opening. Regeneration of cells and endothelium in the area where the device is placed promotes recovery of tissue function and repairs the defect. Radiopaque markers are used for device installation and alignment, but the device position can also be monitored in various situations after installation.

  The foregoing description of the present invention has been set forth in the context of certain preferred embodiments, and details have been set forth for purposes of illustration. It will be apparent to those skilled in the art that various modifications and changes can be made without departing from the scope.

  All references and publications cited in the detailed description are hereby incorporated by reference in their entirety.

30, 40, 50, 60 Occlusion device 31, 41, 51, 61 Occlusion structure 32, 34, 37, 38, 43, 44, 45, 46 Anchor structure 84, 85, 145, 147 Anchor arm 126 Collar structure 140 delivery system 142 delivery catheter 150 guide wire 152 pusher A aneurysm B blood vessel

Claims (13)

An implantable device capable of repairing an opening or cavity of a target tissue defect and transforming from a delivery state having a small diameter shape to a deployed state having a larger diameter shape,
An occlusion structure sized to substantially cover the opening or cavity when the device is in the deployed state, the occlusion structure having at least one opening to facilitate passage of other devices; ,
When the device is in the transport state, a plurality of first anchor structures extending from the closure structure in a first direction relative to the flat portion of the closure structure and from the closure structure to the flat portion and a plurality of second anchor structure that extends in a second direction substantially opposite Te, the first and second anchor structures, spread substantially annular when the device is in the deployed state Forming a structure, wherein the first anchor structure extends into the tissue defect, the second anchor structure contacts the vessel wall ;
The occlusion structure includes a concave structure configured to spread away from the target tissue defect in a deployed state, and the concave structure is attached to a peripheral portion of the occlusion structure and the neck structure An implantable device comprising a skirt having a perimeter greater than the body.   The implantable device of claim 1, wherein the at least one opening in the occlusion structure is dimensioned to allow passage of at least one of a guidewire or catheter into the cavity.   The implantable device of claim 1, wherein the closure structure has a central region surrounded by a peripheral region, and the opening in the closure structure is in the central region.   The implantable device of claim 1, wherein the opening in the closure structure includes a groove.   The implantable device of claim 1, wherein the occlusion structure has a reinforcing structure including at least one of a resilient sheet, a wire framework, or a collar. An implantable device capable of repairing an opening or cavity of a target tissue defect and transforming from a delivery state taking a small diameter shape to a deployed state taking a larger diameter shape,
A closed structure sized to substantially cover the opening or cavity when the device is in the deployed state, the recessed structure configured to spread away from the target tissue defect in the deployed state An occlusion structure comprising:
A plurality of first anchor structures extending in a first direction from a first portion of the closure structure to a flat portion of the closure structure;
A plurality of second anchor structures extending from the closure structure in a second direction substantially opposite the first direction with respect to the flat portion when the device is in the deployed state. And the first and second anchor structures form a substantially closed-loop atraumatic structure when the device is in the deployed state, and the first anchor structure extends into the tissue defect. The second anchor structure contacts the vessel wall;
The implantable device wherein the concave structure includes a neck structure attached to a peripheral edge of the closure structure and a skirt having a larger perimeter than the neck structure.   The implantable device of claim 6, further comprising at least one radiopaque marker disposed on at least one of the first and second anchor structures.   The implantable device of claim 6, wherein the occlusion structure has a substantially continuous occlusion surface area.   7. The implantable device of claim 6, wherein the occlusive structure has at least one opening that facilitates passage of other devices.   7. The implantable device of claim 6, wherein the occlusion structure has radial flexibility configured to replicate the structure and motion of the target tissue.   The occlusion structure is one material selected from the group of silicon materials, rubber materials, woven and non-woven fabrics, fluoropolymer compositions, polymer materials, polyurethane materials, metal materials, thin film shape memory alloys and composites thereof. The implantable device of claim 6, comprising:   7. The implantable device of claim 6, wherein the occlusive structure comprises at least in part a porous surface or a material selected from the group consisting of materials that are permeable to liquid but substantially impermeable to air bubbles. 7. The implantable device of claim 6, further comprising a reinforcement structure near a periphery of the closure structure, the reinforcement structure including at least one of a framework or a generally cylindrical collar.

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