Flow damping device

Abstract

To provide embolic implants.SOLUTION: An embolic device for treating aneurysms or other vascular disorders may be more compliant than conventional devices, while still achieving desired porosity. Specifically, the device may achieve the desired porosity only at discrete sections along the length of the device where desired porosity is required (e.g., sections that will block the neck of the aneurysm upon deployment). The remaining sections of the device can be configured to increase the device's compliance. For example, the remaining sections can be formed from less material than the sections with the desired porosity. In some instances, the sections with the desired porosity are formed from mesh-screen segments and the remaining sections are formed from coil segments. In some instances, the mesh-screen segments are configured to further enhance the device's compliance. For example, the mesh-screen segment can be formed from a layered structure that achieves greater compliance than conventional braided structures.SELECTED DRAWING: None

Description

Technical Field

[0001] Cross - reference to related applications This application claims the priority and benefit of U.S. Provisional Patent Application No. 62 / 546,809, filed on August 17, 2017, and the entire disclosure thereof is incorporated herein by reference.

[0002] Generally, various embodiments of the present invention relate to embolization implants for minimally invasive treatment of aneurysms (e.g., sidewalls, bifurcations, bicuspid, wide - neck, etc.) and other vascular disorders. More particularly, it relates to an embolization implant characterized by specific discrete sections that achieve a desired porosity and other sections that increase the compliance of the device.

Background Art

[0003] Generally, an aneurysm is a swelling or bulge that forms a cavity in the wall of a blood vessel. Certain aneurysms are cerebral aneurysms that form in the arteries of the brain. Cerebral aneurysms can occur suddenly without initial symptoms and can cause severe pain. Generally, in 15% of cases of cerebral aneurysms, the patient dies suddenly at the onset of the cerebral aneurysm, and in another 15% of cases of cerebral aneurysms, the patient dies during medical treatment. In 30% of cases of cerebral aneurysms, the patient survives after treatment but experiences severe sequelae. Thus, cerebral aneurysms (or any aneurysm) are a very concerning disease.

[0004] The treatment of aneurysms and other similar vascular disorders often involves the placement of micro - coils into the cavity formed by the aneurysm or disorder. By doing so, blood can be coagulated, additional blood inflow can be prevented, and the risk of rupture of the aneurysm or disorder (i.e., embolization) can be reduced. For it to be effective, the embolization micro - coils must apply just enough pressure to prevent additional blood inflow, but must not apply excessive pressure that causes rupture.

[0005] A key parameter for most embolization devices is porosity, which is an indicator of the amount of fluid that can pass through the embolization device and enter the aneurysm. To achieve the desired porosity, most conventional embolization devices are made from braided wire or mesh-like structures that form small holes 101 of a specific size (e.g., shown in Figure 1). While these structures can be effective in achieving the desired porosity, the amount of material required by the structure (e.g., numerous overlapping wires) can negatively impact the compliance of the device. Compliance (sometimes referred to as "flexibility") is an indicator of the flexibility and adaptability of the device. If the embolization device is too rigid, it becomes difficult to deliver fluid through winding passages, potentially applying excessive pressure to the aneurysm wall and increasing the risk of rupture. Recent embolization devices have sacrificed high compliance to achieve the desired porosity. [Overview of the project] [Problems that the invention aims to solve]

[0006] Therefore, there is a need for improved embolization devices that can achieve the desired porosity without making significant compromises on compliance. [Means for solving the problem]

[0007] In various embodiments, the present invention relates to an improved embolization device that achieves desired porosity without compromising the same level of compliance as conventional devices. Specifically, the device, for example, requires desired porosity when the device is deployed to the neck of the aneurysm ( Alternatively, the system utilizes the fact that it consists only of specific discrete areas along the length of the device (sometimes referred to as "porous areas" in this specification), such as the area of ​​the device that seals the opening. A “porous region” refers to a portion of the device that possesses a desired level of porosity. In some cases, this desired porosity of the porous region is greater than that of the rest of the device, but in some cases the reverse is also true. The rest of the device (sometimes referred to herein as the “compliance region”) does not need to have the desired level of porosity and can therefore be configured to increase the compliance of the device. For example, the compliance region may be formed from less material than the porous region. An example of a compliance region is a region of the device that, when the device is deployed, is located in the middle of the aneurysm cavity or along the inner wall of the aneurysm cavity. Including a compliance region can increase the overall compliance of the device as a whole, resulting in a device with superior compliance compared to current devices that unnecessarily maintain the desired level of porosity throughout their entire length.

[0008] In general, in one embodiment, embodiments of the present invention feature an embolization device for use in treating vascular disorders. The embolization device may comprise a first coil section, a second coil section, and a mesh screen section positioned between the first coil section and the second coil section along the length of the embolization device.

[0009] In various embodiments, each of the first and second coil sections comprises a helically wound wire. In some examples, the first and second coil sections each have greater compliance than the mesh screen section. In some examples, the mesh screen section has greater porosity than each of the first and second coil sections. When the mesh screen section is in an unfolded configuration, the mesh screen section may have 60% to 80% porosity.

[0010] In various embodiments, the mesh screen section comprises two layers which may have different thicknesses. In some cases, at least a portion of each of the two layers is arranged in different parallel planes. In some cases, at least a portion of each of the two layers is arranged in the same plane. In some examples, the two layers are fixed to each other. In other examples, the two layers can move freely relative to each other. The two layers may be spaced apart from each other by a predetermined distance. Furthermore, the mesh screen section may have perforations that penetrate the thickness. In certain examples, the mesh screen section further comprises a first extended portion and a second extended portion adapted to be inserted into lumens formed by the first coil section and the second coil section, respectively, in order to connect the mesh screen section to a first coil section and a second coil section. In some cases, different parts of the embolization device have different thermomechanical properties.

[0011] In general, in another embodiment, embodiments of the present invention feature a method for treating a patient's vascular disorder. The method involves an embolization device comprising a coil section and a mesh screen section coupled to the coil section, (i) the coil section being placed in a cavity formed by the vascular disorder. (ii) the step of delivering into the vascular lesion such that the mesh-like screen section is positioned across the neck of the vascular lesion.

[0012] In various embodiments, the vascular obstruction is an aneurysm. In some examples, the delivery step includes releasing the device from the distal end of the delivery pusher. In such examples, the method may further include advancing the delivery pusher through a microcatheter having a distal end positioned within the vascular obstruction. The method may further include delivering a second embolizing device into the vascular obstruction without repositioning the microcatheter. In some examples, the initially delivered embolizing device comprises an additional coil section, and a mesh screen section is positioned between the coil section and the additional coil section along the length of the embolizing device. In some cases, the coil section comprises a helically wound wire. The coil section may have greater compliance than the mesh screen section. The mesh screen section may have greater porosity than the coil section. When delivered, the mesh screen section may have 60% to 80% porosity.

[0013] In various embodiments, the mesh screen section comprises two layers that may have different thicknesses. In some cases, at least a portion of each of the two layers is arranged in different parallel planes. In some cases, at least a portion of each of the two layers is arranged in the same plane. In some examples, the two layers are fixed to each other. In other examples, the two layers can move freely relative to each other. The two layers may be spaced apart from each other by a predetermined distance. The mesh screen section may have perforations that penetrate through the thickness. In some cases, different parts of the embolization device have different thermomechanical properties.

[0014] In general, in yet another embodiment, embodiments of the present invention feature a method for manufacturing an embolization device. The method may include the steps of forming a first coil section and a second coil section, forming a mesh screen section, and connecting the mesh screen section between the first coil section and the second coil section along the length of the embolization device.

[0015] In various embodiments, the step of forming a first coil section and a second coil section includes winding at least one wire in a spiral. In some examples, a mesh-like screen is formed. Steps to form a lean section include, for example, using removal manufacturing techniques such as laser technology, mechanical technology, wet chemical technology, electrochemical masking technology, maskless electrochemical technology, etching, milling, photochemical processing, and / or photoelectrochemical processing. Some examples The step of joining the mesh screen section between the first coil section and the second coil section includes inserting the first and second extended portions of the mesh screen section into the lumens formed by the first and second coil sections, respectively. In some cases, the step of forming the first and second coil sections, and / or the step of forming the mesh screen section, includes forming different parts of the embolization device to have different thermomechanical properties.

[0016] These and other objectives, along with the advantages and features of the embodiments of the invention disclosed herein, will become more apparent through the following description, the accompanying drawings, and references to the claims. Furthermore, it will be understood that the features of the various embodiments described herein are not mutually exclusive and can exist in various combinations and substitutions. The present invention provides, for example, the following items: (Item 1) An embolization device used when treating vascular disorders, The first coil section and The second coil section, Mesh-like screen section and Equipped with, An embolization device in which the mesh-like screen section is arranged between the first coil section and the second coil section along the length of the embolization device. (Item 2) The embolization device according to item 1, wherein the first coil section and the second coil section each comprise a wire wound in a spiral shape. (Item 3) The plugging device according to item 1, wherein the first coil section and the second coil section each have a compliance larger than that of the mesh screen section. (Item 4) The plugging device according to item 1, wherein the mesh screen section has a porosity larger than each of the first coil section and the second coil section. (Item 5)​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​​ (Item 15) The embolic device according to item 1, wherein different parts of the embolic device have different thermomechanical properties. (Item 16) A method for treating vascular disorders in patients, An embolization device comprising a coil section and a mesh-like screen section coupled to the coil section, The coil section is positioned within the cavity formed by the vascular damage, The mesh-like screen section is positioned to extend across the neck of the vascular lesion. A method comprising the step of delivering within the vascular lesion. (Item 17) The method according to item 16, wherein the vascular disorder includes an aneurysm. (Item 18) The method according to item 16, wherein the delivery step includes releasing the embolizing device from the distal end of the delivery pusher. (Item 19) The method of item 18, further comprising the step of advancing the delivery pusher through a microcatheter having a distal end positioned within the vascular lesion. (Item 20) The method according to item 19, further comprising the step of delivering a second embolizing device into the vascular lesion without repositioning the microcatheter. (Item 21) The method according to item 16, wherein the embolic device further comprises an additional coil section, and further the mesh screen section is positioned between the coil section and the additional coil section along the length of the embolic device. (Item 22) The method according to item 16, wherein the coil section comprises a wire wound in a spiral shape. (Item 23) The method according to item 16, wherein the coil section has a greater compliance than the mesh-like screen section. (Item 24) The method according to item 16, wherein the mesh-like screen section has greater porosity than the coil section. (Item 25) The method according to item 16, wherein the mesh-like screen section is 60% to 80% porous when delivered. (Item 26) The method according to item 16, wherein the mesh-like screen section comprises two layers. (Item 27) The method according to item 26, wherein the two layers have different thicknesses. (Item 28) The method according to item 26, wherein at least a portion of each of the two layers is arranged in different parallel planes. (Item 29) The method according to item 26, wherein at least a portion of each of the two layers is arranged in the same plane. (Item 30) The method according to item 26, wherein the two layers are fixed to each other. (Item 31) The method according to item 26, wherein the two layers can move freely relative to each other. (Item 32) The method according to item 26, wherein the two layers are spaced apart from each other at a predetermined distance. (Item 33) The method according to item 16, wherein the mesh-like screen section has perforations that penetrate through the thickness. (Item 34) The method according to item 16, wherein different parts of the embolization device have different thermomechanical properties. (Item 35) A method for manufacturing an embolization device, The steps include forming a first coil section and a second coil section, The steps include forming a mesh-like screen section, The steps include: connecting the mesh-like screen section between the first coil section and the second coil section along the length of the embolization device; Methods that include... (Item 36) The method according to item 35, wherein the step of forming the first coil section and the second coil section includes winding at least one wire in a spiral shape. (Item 37) The method of item 35, wherein the step of forming the mesh-like screen section includes using a removal manufacturing technique. (Item 38) The method according to item 37, wherein the removal manufacturing technique is selected from the group consisting of laser technology, mechanical technology, wet chemical technology, electrochemical masking technology, maskless electrochemical technology, etching, milling, photochemical processing, and photoelectrochemical processing. (Item 39) The method according to item 35, wherein the step of connecting the mesh-like screen section between the first coil section and the second coil section includes inserting the first extended portion and the second extended portion of the mesh-like screen section into the lumens formed by the first coil section and the second coil section, respectively. (Item 40) The method according to item 35, wherein at least one of the steps of forming the first coil section and the second coil section and the step of forming the mesh-like screen section forms different parts of the embolic device such that they have different thermomechanical properties.

[0017] In the drawings, similar reference numerals generally refer to the same part across different drawings. Furthermore, the drawings are not necessarily to a constant scale; instead, emphasis is generally placed to illustrate the principles of the invention. Various embodiments of the invention are described below with reference to the following drawings. [Brief explanation of the drawing]

[0018] [Figure 1] This is an image of an example of a conventional embolization device formed from braided wire. [Figure 2] This is a schematic view from above of an embolization device according to one embodiment of the present invention in a straightened configuration. [Figure 3]This is a schematic lateral cross-sectional view of a portion of an embolization device according to one embodiment of the present invention, which is formed from multiple layers. [Figure 4A] This is a schematic diagram of a different part of an embolization device according to one embodiment of the present invention, which is formed from multiple layers. [Figure 4B] This is a schematic diagram of a different part of an embolization device according to one embodiment of the present invention, which is formed from multiple layers. [Figure 5A] This figure shows various layer configurations of a portion of an embolization device according to various embodiments of the present invention. [Figure 5B] This figure shows various layer configurations of a portion of an embolization device according to various embodiments of the present invention. [Figure 5C] This figure shows various layer configurations of a portion of an embolization device according to various embodiments of the present invention. [Figure 5D] This figure shows various layer configurations of a portion of an embolization device according to various embodiments of the present invention. [Figure 6] This is a schematic view from above of an extended portion used to attach a part of an embolization device according to one embodiment of the present invention. [Figure 7] This is an image of an embolization device according to one embodiment of the present invention, inserted into a microcatheter. [Figure 8A] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8B] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8C] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8D] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8E] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8F]These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8G] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8H] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8I] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8J] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8K] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8L] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 8M] These are images illustrating various embodiments of the embolization device according to the present invention, in a deployed configuration, at various stages of deployment. [Figure 9] This is an image illustrating the attachment of an extension portion and a delivery pusher according to one embodiment of the present invention. [Modes for carrying out the invention]

[0019] Embodiments of the present invention relate to improved designs for embolization devices, as well as methods for using and manufacturing such improved devices. As previously mentioned, porosity is a critical parameter for embolization devices because it determines how much fluid can pass through the embolization device into the aneurysm, which can directly affect how effective the embolization device is in treating aneurysms. As shown in Figure 1, in many conventional devices, the desired porosity is achieved by a braided or mesh-like structure of overlapping wires that form small holes 101 of the desired size. While this technique can be effective in generating the desired porosity, the overlapping wires make the device stiff and reduce its compliance. Most conventional devices achieve the desired porosity along their entire length, which results in an unnecessarily excessively large material density that significantly reduces the device's compliance.

[0020] The inventors developed a solution to this problem by recognizing and understanding that the desired porosity is only required in limited, discrete portions along the length of the device. Specifically, the desired porosity only needs to be achieved in the portions of the device that interact with (and thus affect) the blood flowing into the aneurysm. Typically, these portions are those located across the opening between the blood vessel and the aneurysm cavity (sometimes called the "neck" of the aneurysm) when the device is deployed. The inventors recognized that the remaining portions of the device, i.e., those that do not interact with or affect the blood flowing into the aneurysm, do not need to have the desired porosity. Examples of portions that do not interact with or affect the blood flowing into the aneurysm include portions of the device located in the middle of the cavity or along the inner wall of the cavity when the device is deployed. The inventors recognized and understood that portions of the device that do not need to have the desired porosity can be configured differently from the porous regions, for example, to be significantly more compliant than the porous regions, thereby increasing the overall compliance of the entire device.

[0021] Figure 2 shows a portion of an exemplary embodiment of the improved embolization device 100 of the present invention. The device 100 comprises a porous area 102 and a compliance area 104. Although Figure 2 depicts one porous area 102 and two compliance areas 104, generally, the device 100 can include any number of porous areas 102 (e.g., one, two, three, etc.) and any number of compliance areas 104 (e.g., one, two, three, etc.) as desirable for various applications. For example, in some embodiments, the device 100 comprises one porous area 102 and one compliance area 104. In another example, the device 100 may comprise three porous areas 102 and two compliance areas 104. Many other examples are possible.

[0022] In various embodiments, the porous areas 102 and compliance areas 104 are arranged in a continuous, alternating pattern along the length of the apparatus 100. For example (as shown in Figure 2), the apparatus 100 may comprise a compliance area 104, followed by a porous area 102, followed by another compliance area 104, and optionally followed by another porous area 102, and so on. In other embodiments, the porous areas 102 and compliance areas 104 may be arranged using any other arrangement. For example, multiple porous areas 102 may be arranged adjacent to each other, and / or multiple compliance areas 104 may be arranged adjacent to each other. In some cases, the arrangement of the porous areas 102 and compliance areas 104 is constant (e.g., repeating) along the entire length of the apparatus 100. In other cases, the arrangement of the porous areas 102 and compliance areas 104 varies along the length of the apparatus 100. For example, in a central location, areas 102 and 104 are arranged in a continuous alternating manner, while in other locations, areas may be arranged as multiple adjacent porous areas 102 and / or multiple compliance areas 104.

[0023] In various embodiments, the spaces between sections of the device 100 are controlled to optimize the shape of the device 100 when delivered to the aneurysm. For example, in some cases, the space between each porous and / or compliant section may be constant. In other cases, the space between each porous and / or compliant section may vary along the length of the device 100. Generally, the size and / or shape of the device 100 can be controlled, and once the device 100 is delivered to the aneurysm, it can take any shape to optimize the shape / size of the device 100.

[0024] In various embodiments, the compliance area 104 may be a coiled section, as shown in Figure 2. Since the coiled section is an exemplary type of compliance area, both coiled sections and compliance areas are referred to in this application by reference numeral 104. In some cases, the coiled section 104 is formed from wound wire (e.g., helically wound wire). Coiled structures are generally far more compliant than braided structures, and including these structures along the length of the apparatus 100 can increase the overall compliance of the apparatus 100. Although this specification often describes and depicts the compliance area 104 as a coiled structure, the compliance area 104 can take other forms. Generally, the compliance area 104 can take any form that results in an area 104 that is more compliant than the porous area 102. As one of many examples, the compliance area 104 may be formed from braided wire sections and / or mesh sections with less material, or otherwise configured to have greater compliance than the porous area 102.

[0025] In various embodiments, the compliance region 104 and the porous region 102 may differ in properties other than compliance, or in addition to compliance. Generally, the compliance region 104 and the porous region 102 may differ from each other with respect to any property and by any desired magnitude. As an example, the compliance region 104 and the porous region 102 may have different thermomechanical properties. Nitinol is an example material in which the thermomechanical properties can be set to favorable values, but this can be done with other materials (e.g., most metals). A non-exclusive list of example thermomechanical properties that may differ between the compliance region 104 and the porous region 102 includes (i) strength, ductility, and / or toughness depending on prior hot and / or cold heat treatment, (ii) austenite phase transformation temperature, and (iii) hyperelastic and shape memory properties (e.g., temperature and / or stress-strain behavior depending on prior hot and / or cold heat treatment). Many other examples of thermomechanical properties are also possible.

[0026] In other examples where there are multiple compliance areas 104 and / or multiple porous areas 102, other areas of the same type (e.g., different compliance areas 104 and / or different porous areas 102) may have different properties (e.g., thermomechanical properties) from one another. In yet another example, a single compliance area 104 and / or porous area 102 may have different properties in different locations. For example, a porous area 102 may have thermomechanical properties that have a first value near its center and different values ​​near its periphery. One advantage of varying the thermomechanical properties (or other properties) within the apparatus 100 is that the apparatus can be tuned, for example, by adjusting the phase transformation temperature and / or expansion force characteristics at different locations within the apparatus 100 to achieve desired deployment (or other performance) characteristics. In various embodiments, any two components (or locations) of the apparatus 100 may have the same properties as one another.

[0027] In various embodiments, the porous region 102 itself has a novel and unique design that improves the function of the embolization device 100. In some cases, the improved porous region 102 can be used together with the compliance region 104 (as described above), so that multiple features enhance the function of the device 100. In other cases, the entire device 100 can be formed from the improved porous region 102, and the porous region 102 can independently enhance the function of the device 100. Specifically, in various embodiments, the porous region 102 is formed from a novel and unique structure that features improved properties and characteristics compared to conventional braided / mesh wires while achieving the desired porosity. In various embodiments, the desired porosity may be in the range of about 50% to about 90% porosity, about 60% to about 80% porosity, about 60% to about 70% porosity, and about 70% to about 80% porosity.

[0028] For example, the porous region 102 may be a mesh-like screen section formed from at least one flat surface (e.g., a layer) opposite to the cylindrical surface of the wire. Since the mesh-like screen section is an exemplary type of porous region, both the mesh-like screen section and the porous region are referred to as reference numeral 102 in this application. A structure formed from layers of flat surfaces may be more flexible, wrinkle-resistant, and expandable than a structure formed from overlapping wires, while achieving the desired porosity. In general, the mesh-like screen section 102 may be formed from any number of layers arranged / laminated in any desired manner. For example, in the simplest case, the mesh-like screen section 102 is formed from a single layer. In other examples, the mesh-like screen section 102 is formed from multiple layers. In some cases, the various layers have different thicknesses and are located in different parallel planes and / or overlapping parallel planes.

[0029] Figure 3 is a lateral cross-sectional view of the relatively complex layered structure of the example. Each of elements 1-7 in Figure 3 depicts a different layer of the mesh-like screen section 102. As illustrated by layers 1 and 2, each layer may have a different thickness (dimension along the y-axis). As illustrated by layers 3 and 4, at least a portion of different layers may exist in different parallel planes (e.g., the lower portion of layer 3 and the upper portion of layer 4 are in different parallel planes). Also as illustrated by layers 3 and 4, at least a portion of different layers may exist in overlapping planes (e.g., the middle portions of both layers 3 and 4 overlap). As illustrated by layers 5 and 6, in some examples, certain layers do not overlap at all. Conversely, as illustrated by layers 4 and 7, certain layers can overlap completely (e.g., they exist in the same plane across the entire thickness of one layer and / or both layers).

[0030] As illustrated by layers 5 and 6, the layers may have different widths (dimensions along the x-axis). As illustrated by layers 1 and 4, the layers may have the same width. As illustrated by layers 5 and 6, in some examples there may be gaps 302 between the layers. The gaps can be in either the y-axis direction (shown in Figure 3) or the x-axis direction. For example, a gap in the x-axis direction may be formed by perforations that penetrate the thickness formed in the mesh screen section 102. An example of a perforation 108 that penetrates the thickness is shown in Figure 2. When the device 100 is deployed in an aneurysm, fluid flows through the perforation 108 that penetrates the thickness to enter the aneurysm. Thus, the perforation 108 functions similarly to the small holes 101 formed in a conventional braided structure. For example, the size of the perforation 108 can determine the porosity of the mesh screen section 102, which in turn affects the amount of fluid that can traverse the mesh screen section 102 and enter the aneurysm. However, since the perforations 108 can be configured to have a constant size (or, for example, a controlled variability in embodiments where layers can move relative to each other), they are generally superior to the small holes 101 in braided structures, which allows for more consistent and predictable porosity to be achieved. In conventional braided structures, the wires often move relative to each other, which changes the size of the small holes and makes it difficult to achieve predictable porosity.

[0031] In general, the thickness-penetrating perforations 108 can be formed in any shape or size to achieve the desired porosity. In some cases, the thickness-penetrating perforations have a consistent shape and size across the surface of the mesh-like screen area 102. In other cases, the thickness-penetrating perforations have different shapes and / or sizes at different locations across the surface of the mesh-like screen area 102. In some examples, the thickness-penetrating perforations affect other properties of the mesh-like screen area 102, such as flexibility, expandability, and wrinkle resistance.

[0032] As illustrated by all the layers in Figure 3, the width of a layer may be less than the width of the entire mesh screen area 102. In other examples, one or all of the layers may have a width that extends across the entire width of the mesh screen area 102 (not shown in Figure 3). In various embodiments, the aforementioned relationships may exist between adjacent or non-adjacent layers in either the x-axis or y-axis direction. Many other examples of relationships between layers are possible.

[0033] In various embodiments, the layers are joined together at a joint 304 formed along the x-axis using any known technique. For example, the layers may be formed separately and joined together using known adhesion techniques (e.g., adhesives, welding, etc.). In another example, the layers may be formed from a single piece of material using removal manufacturing techniques (e.g., laser techniques, mechanical techniques, wet chemical techniques, electrochemical masking techniques, maskless electrochemical techniques, etching, milling, photochemical processing, and / or photoelectrochemical processing). In addition to the joint 304 formed between the layers along the x-axis, a joint 306 may be formed along the y-axis. In some cases, the layers are fixed together at the joint 306 using known bonding techniques such as those described above. In some cases, the layers can move freely relative to each other at the joint 306. In a particular example, a single mesh screen section 102 may have some layers fixed together and other layers that can move freely relative to each other.

[0034] Figures 4A and 4B show examples of the configuration of a mesh screen section 102. Figure 4A is a top view of the mesh screen section 102 showing layers 402, 404, and 406. Figure 4B is a perspective view of the mesh screen section 102 showing that layers 402 and 404 have different thicknesses and that at least a portion of each of layers 402, 404, and 406 are located in different planes.

[0035] Figures 5A to 5D provide further examples of various mesh-like screen section configurations. Figure 5A indicates the viewpoint (i.e., the view from X) from which each of Figures 5B to 5D is depicted. Figure 5B depicts a layered structure in which the leftmost edges of two surfaces (surface #1 and surface #2) are offset by a certain depth. Figure 5C depicts a layered structure in which the leftmost edges of surfaces #1 and #2 are offset by a smaller depth than shown in Figure 5B. Figure 5D depicts a layered structure in which the leftmost edges of surfaces #1 and #2 are not offset and exist in the same plane.

[0036] In general, the mesh screen sections 102 can be attached to adjacent sections using any technique that ensures proper adhesion between sections. For example, as shown in Figure 2, in some embodiments, the mesh screen section 102 comprises at least one mesh screen extension 602 that can be used to attach to an adjacent section. When the adjacent sections are coil sections 104, the mesh screen extension 602 can extend into the lumen formed by the coil sections 104. The mesh screen extension 602 can be attached to the coil sections 104 using any suitable attachment or joining technique, such as mechanical fitting, adhesive, welding, corresponding mating contours, interlocking tabs, notches, and groove configurations. In some cases, the mesh screen extension 602 does not adhere directly to the coil section 104, but rather the coil section 104 is held between two other structures to which the mesh screen extension 602 adheres (e.g., between two mesh screen sections 102, or between the mesh screen section 102 and the delivery pusher). In some cases, the coil section 104 is held between two structures and directly adheres to the mesh screen extension 602. Similarly, the mesh screen extension 602 can be attached to the delivery pusher using any suitable attachment method. In one example shown in Figure 9, the mesh screen extension 602 forms a loop 902 that engages with the wire 904 of the delivery pusher assembly. In some cases, the wire can be cut to release the mesh screen extension 602 (and the device 100) from the delivery pusher. In other examples, the mesh-like screen extension 602 is attached to the delivery pusher using corresponding interlocking contours, interlocking tabs, notches, and grooves, adhesives, welding, etc.

[0037] In some embodiments, the mesh screen extension 602 extends throughout the entire coil section 104 until it reaches another section (e.g., another mesh screen section 102, a structure for attachment to a delivery pusher, etc.). In some examples, the mesh screen extension 602 extends substantially along the entire length of the device 100 (excluding the mesh screen section 102 itself) and forms a core component of the device 100. In some cases, the mesh screen extension 602 ensures that the insertion force applied from the delivery pusher is transmitted along the entire length of the device 100. This may be necessary, for example, if the coil section 104 does not properly transmit the insertion force. In some cases, the mesh screen extension 602 restrains the coil section 104 and prevents undesirable elongation (or elongation of an undesirable magnitude) of the coil section 104. As shown in Figure 2, each mesh screen section 102 may have multiple mesh screen extensions 602, for example, one mesh screen extension 602 for each adjacent coil section 104.

[0038] Figure 6 is an enlarged view of one of the mesh-like screen extensions 602 shown in Figure 2. As shown, the mesh-like screen extension 602 may have a coupling feature 604 at its end, which can be used to attach to other sections and / or delivery pushers. In one example, the mesh screen extension 602 is symmetrical. In other examples, the mesh screen extension 602 is asymmetrical. For example, the coupling features 604 at either end of the mesh screen extension 602 may be different (for example, one coupling feature may be adapted to attach to the coil section 104, and a different coupling feature may be adapted to attach to the delivery pusher).

[0039] During operation, the embolization device 100 may be introduced, delivered, positioned, and implanted within the vascular lesion using a microcatheter. The microcatheter may be a flexible, small-diameter catheter having an inner diameter between, for example, 0.016 inches and 0.021 inches. The microcatheter may be introduced by an introduction sheath / guide catheter combination placed in the femoral artery or inguinal region of the patient. In some cases, the microcatheter is guided into the vascular lesion by a guide wire (e.g., a long, torsionable proximal wire section with a more flexible distal wire section designed to be advanced within a winding vessel). Such a guide wire may be made visible using fluoroscopy and can be used to first approach the vascular lesion, thereby allowing the microcatheter to advance into the lesion across the guide wire.

[0040] In some cases, as the tip of the microcatheter approaches the vascular lesion, the guide wire is removed from the catheter lumen. The embolization device 100 is then positioned at the proximal open end of the microcatheter and can be advanced through the microcatheter by a delivery mechanism. The embolization device 100 may be positioned within the lumen of the microcatheter while being in a straightened form. For example, the coil section 104 may be straightened to fit within the catheter lumen. In some cases, the mesh screen section 102 may be rolled, folded, or otherwise compressed to fit within the lumen of the microcatheter (see Figure 7, where the microcatheter is identified by reference numeral 702, as an example). The user (e.g., a physician) may advance and / or retract the embolization device 100 several times to obtain the desired position of the embolization device 100 within the lesion. In some cases, the mesh screen section 102 may be guided and pushed by the adjacent coil section 104. Once the embolization device 100 is satisfactorily positioned, it can be released into the lesion.

[0041] Upon release, the embolization device 100 can form a secondary shape. In some cases, the formation of a secondary shape to the vascular lesion upon deployment is caused by the shape-memory properties of the material (e.g., nitinol) used to form at least a portion of the embolization device 100 (e.g., compliance area 104). Generally, the secondary shape can be any shape desirable for treating an aneurysm. For example, the shape may include a porous area 102 positioned across the neck of the aneurysm and a compliance area 104 positioned in the middle of the aneurysm cavity and / or along the inner wall of the aneurysm cavity, as this may be desirable for treating an aneurysm. Examples of shapes of the embolization device 100 formed into a secondary shape are shown in Figures 8A–8M. In Figures 8C–8M, the images depict the embolization device 100 being deployed from the microcatheter 702. Images 8H-8M depict the embolization device 100 at various stages of deployment within a glass model of an aneurysm sac 802, which simulates the environment of an aneurysm in the body.

[0042] In various embodiments, the embolization device 100 is delivered in a more effective manner than conventional devices. For example, current techniques for delivering conventional braided devices typically have a withdrawal zone that requires the microcatheter to be positioned directly at the neck of the aneurysm (i.e., not within the aneurysm cavity). Once the first device is released, it blocks the neck of the aneurysm, preventing re-access to the aneurysm cavity, such as for placing additional devices / coils. This requires the physician to select a device of perfect size that cannot be supplemented with additional devices, which can be difficult and often unusable.

[0043] Various embodiments of the present invention provide solutions to this problem. Specifically, since the embolization device 100 does not contain the high material density required to achieve the desired porosity along its entire length, the microcatheter can be placed directly into the aneurysm cavity to detach the embolization device 100. After the first device 100 is deployed, the microcatheter can remain in the aneurysm cavity, so that additional devices / coils can be delivered without the need to remove or reposition the microcatheter. This allows physicians to easily insert additional devices / coils that may need to "wrap" the aneurysm and / or stabilize the embolization device 100. This functionality reduces the need for the embolization device 100 to be perfectly sized, thereby enabling the embolization device 100 to be used more frequently and to treat a large number of aneurysms / vascular disorders with the embolization device 100.

[0044] In various embodiments, including the compliance area 104 in the embolization device 100 results in the embolization device 100 behaving more like a pure bare platinum coil than a conventional braided device. Generally, the mechanical behavior and deployment of the embolization device 100 are much closer to the mechanical behavior and deployment of a pure bare platinum coil than to a conventional braided device. This may be advantageous because many physicians are considered to be familiar with the sensation of delivering a bare platinum coil through known conventional training and experience. Therefore, the embolization device 100 described in this application may be easier for physicians to use than a conventional braided device. In some embodiments, the embolization device 100 is, for example, a firefly. The device includes a radiopaque area (e.g., coil section 104) that increases the visibility of the embolization device 100 when exposed to optical fluoroscopy imaging and improves safety during delivery. Providing a radiopaque area in conventional braiding devices is far more difficult.

[0045] Other aspects of the present invention generally relate to a method for manufacturing an embolization device 100. Generally, the method may include the steps of forming a first coil section and a second coil section, forming a mesh screen section, and joining the mesh screen section between the first coil section and the second coil section along the length of the embolization device. Components of the device may be manufactured using proven biocompatible materials and known manufacturing processes and techniques. For example, as described above, the coil section 104 can be formed by spirally winding a wire, and the mesh screen section 102 can be formed using standard joining techniques (e.g., adhesives, welding, etc.), removal manufacturing techniques, and / or combinations thereof. The mesh screen section 102 can be attached to the coil section 104 using a mesh screen extension 602 or other techniques, as described above.

[0046] While specific embodiments of the present invention have been described, it will be apparent to those skilled in the art that other embodiments incorporating the concepts disclosed herein can be used without departing from the spirit and scope of the invention. Therefore, the embodiments described herein should be considered in all respects as merely illustrative and not restrictive. [Explanation of Symbols]

[0047] 1, 2, 3, 4, 5, 6, 7 layers 100 Embolization device 101 Small hole 102 Porous area, mesh-like screen area 104 Compliance area, coil section 108 Perforation that penetrates through thickness 302 Gap 304, 306 joint 402, 404, 406 layers 602 Mesh-like screen extension 604 Joint Features 702 Microcatheter 802 Aneurysm sac 902 Loop 904 Wire

Claims

1. An embolization device used when treating vascular disorders, The first compliant area and A second compliant area, which is different from the first compliant area and is separated from the first compliant area, A mesh-like screen section formed from a non-braided structure comprising two layers, both of which are planar layers, and the non-braided structure comprising a plurality of supports forming a grid, and Equipped with, The mesh-like screen section is positioned along the length of the embolization device between the first compliant area and the second compliant area. The first compliant area is connected to the first end of the mesh-like screen section, and the second compliant area is connected to the second end of the mesh-like screen section. Embolization device, wherein the mesh-like screen section is structured and arranged to have greater porosity than both the first compliant area and the second compliant area, the porosity being proportional to the amount of fluid per unit surface area passing through the thickness of the structure, each of the two layers being arranged in parallel planes, and each of the two layers being separated from each other by a gap of a predetermined distance.

2. The embolization device according to claim 1, wherein each of the first compliant area and the second compliant area comprises a coil having a helically wound wire.

3. The embolization device according to claim 1, wherein the two layers have different thicknesses.

4. The embolization device according to claim 1, wherein the two layers are fixed to each other.

5. The embolization device according to claim 1, wherein the two layers can move freely relative to each other.

6. The embolization device according to claim 1, wherein the mesh-like screen section further comprises a first extended portion and a second extended portion adapted to connect the mesh-like screen section to the first compliant area and the second compliant area, respectively.

7. The embolization device according to claim 1, wherein the first compliant area, the second compliant area, and the mesh-like screen section have different thermomechanical properties, the thermomechanical properties being one or more of (i) strength, ductility, or toughness depending on prior hot or cold heat treatment, (ii) austenite phase transformation temperature, and (iii) hyperelastic properties and shape memory properties.

8. The embolization device according to claim 1, wherein each of the first and second compliant areas comprises a braided wire.

9. The embolization device according to claim 1, wherein the first and second compliant areas (i) each have a mesh and (ii) are configured to have greater compliance than the mesh-like screen section.

Images