Intravascular Devices

Abstract

An intravascular device comprising: an expandable body having an expanded configuration and a contracted configuration, the expandable body in the expanded configuration having a convexly curved shape having a base and a wall; and a connector, the connector being attached to the expandable body and recessed into the convexly curved shape.

Description

[Technical field]

[0001] Related Applications This application claims the benefit of priority to Provisional Patent Application No. 63 / 240,939, filed September 5, 2021 (Attorney Docket No. 89233), and Provisional Patent Application No. 63 / 135,629, filed January 10, 2021 (Attorney Docket No. 85106), the contents of which are incorporated by reference in their entireties herein. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to the treatment of intravascular abnormalities, and more particularly, but not exclusively, to the treatment of aneurysms using expandable intravascular devices.

[0003] U.S. Patent Application No. 2011 / 0144669 discloses, "An implant for treating cerebral aneurysms, particularly peripheral aneurysms, comprises an elongate shaft and a neck cover removably secured to an embolic delivery catheter. The shaft thus serves to protect the delivery catheter from adhesion with embolic material and to orient and position the cover towards the aneurysm neck as connecting or adhering the shaft to embolic material delivered through the catheter secures the cover in place. The implant may be retained in the aneurysm by the shaft or the shaft and cover interacting with and / or adhering to resident embolic material."

[0004] US Patent Application Publication No. 2012 / 0330341 discloses "An embolic implant, method of manufacture and delivery method are disclosed. The implant is particularly suited for treating aneurysms with a stent cage."

[0005] U.S. Patent No. 9,393,022 discloses, "An embolic implant, delivery system, and method of manufacture and delivery are disclosed. The implant is deployed in two stages. If the size observed in the first stage is appropriate, the implant is deployed in a second stage and detached. If the implant is not of appropriate size in the first stage, it is designed to be removed and replaced with a more appropriately sized implant or switched to another selected treatment option. Some implant configurations may be removed after second stage deployment as well."

[0006] Further background art includes European Patent Publication No. EP3136986, U.S. Patent Application No. 2019 / 0269414, U.S. Patent No. 9,629,635, U.S. Patent Application No. 2017 / 0367708, U.S. Patent Application No. 20180140305, Japanese Patent Publication No. JP2019526324, International Patent Application Publication No. WO2019 / 165360, U.S. Patent No. 20200038032, U.S. Patent Application No. 20190090884, International Patent Application Publication No. WO2017 / 106567, U.S. Patent Application No. 2019 / 0269411, U.S. Patent Application No. 2019 / 0343532, European Patent Application Nos. EP2157937, AU2009291548, and U.S. Patent No. 10,335,153. Summary of the Invention

[0007] Below is a non-exhaustive list including some example embodiments of the present invention. The present invention also includes embodiments including less than all of the features of an example, and embodiments that use features from more than one example, even if not explicitly listed below. Example 1. An intravascular device comprising: an expandable body having an expanded configuration and a contracted configuration, the expandable body in the expanded configuration having a convex curved shape having a base and a wall; A connector, The intravascular device, wherein the connector is attached to the expandable body and is recessed within the convex curved shape.

[0008] Example 2. The device of example 1, wherein the device comprises a support providing a bilayer on at least a portion of the expandable body.

[0009] Example 3. The device described in Example 2, wherein the support and the expandable body are connected by the connector.

[0010] Example 4. A device described in any one of Examples 1-2, wherein the expandable body is formed by a tubular structure closed at its proximal end by the connector.

[0011] Example 5. A device described in any one of Examples 1 to 4, comprising a radiation source coupled to the expandable body.

[0012] Example 6. A device described in any one of Examples 2 to 5, wherein one or both of the expandable body and the support comprise a mesh.

[0013] Example 7. The device of example 6, wherein the mesh fiber tips at the ends of one or more portions of the device are blunted.

[0014] Example 8. A device described in any one of Examples 6-7, wherein at least some of the mesh fibers are interconnected at the distal ends of one or more portions of the device.

[0015] Example 9. The expandable body is coupled to the connector from a distal end of the connector, The device of any one of Examples 2 to 8, wherein the support is coupled to the connector from a proximal end of the connector.

[0016] Example 10. A device described in any one of Examples 2 to 8, wherein the expandable body and the support are formed by a single tubular structure that is folded back to provide the expandable body and the support.

[0017] Example 11. A device described in any one of Examples 1 to 9, wherein the expandable body, in the expanded configuration, has sufficient elasticity to resist collapse within the aneurysm.

[0018] Example 12. A device described in any one of Examples 1 to 10, wherein the expandable body includes a support portion that reinforces one or both of a portion of the wall and the base.

[0019] Example 13. The device of example 12, wherein the support includes at least a portion recessed within a volume formed by the wall.

[0020] Example 14. A device described in any one of Examples 12-13, wherein the support includes at least a portion extending around one or both of the wall and the base.

[0021] Example 15. A device described in any one of Examples 12 to 14, wherein the support extends from a distal end of the wall.

[0022] Example 16. A device described in any one of Examples 1 to 14, wherein at least a portion of the expandable body is sufficiently flexible to at least partially conform to the internal shape of the aneurysm.

[0023] Example 17. A device described in any one of Examples 1 to 16, wherein the expandable body is elastically expandable into the expanded configuration.

[0024] Example 18. An intravascular device comprising: an expandable body including two layers and having an expanded configuration and a contracted configuration, wherein when the expandable body is in the expanded configuration, each of the two layers has a convex curved shape including a wall extending from a base; a connector connecting the bases of the two layers; The intravascular device.

[0025] Example 19. An intravascular device as described in Example 18, wherein the connector is recessed within the convex curved shape at least when the expandable body is in the expanded configuration.

[0026] Example 20. An intravascular device described in any one of Examples 18 to 19, wherein the connector defines the proximal end of the expandable body and the ends of the walls of one or both of the layers are unconnected and provide an opening to a volume defined within the wall of the first layer or the second layer.

[0027] Example 21. An intravascular device described in any one of Examples 18 to 20, wherein each of the layers of the expandable body is formed by a tubular structure closed at its proximal end by the connector.

[0028] Example 22. An intravascular device described in any one of Examples 18 to 21, wherein the expandable body is formed by a single tubular structure and is folded back to form the base, the folding nesting one portion of the tubular structure within another portion of the tubular structure.

[0029] Example 23. A device described in any one of Examples 18 to 22, wherein the expandable body is made of mesh.

[0030] Example 24 A device as described in Example 23, wherein the mesh ends are blunted.

[0031] Example 25. A device described in any one of Examples 23 to 24, wherein at least a portion of the mesh fibers are interconnected at the end regions of the expandable body.

[0032] Example 26. A device described in any one of Examples 18 to 25, comprising an upper portion at least partially enclosing a volume enclosed by the wall, the base portion being disposed at a proximal end of the expandable body, the wall extending distally from the base portion, and the upper portion being disposed at a distal portion of the wall.

[0033] Example 27. An intravascular device comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A proximal end; A distal end. a wall connecting the proximal end and the distal end; the expandable body comprising: a connector disposed at the proximal end of the expandable body and connecting the proximal ends of the walls; a support disposed within a volume defined by the walls, a support proximal end; a support distal end; a support wall extending from the connector at the support proximal end and extending toward the support distal end; The support comprises: The intravascular device, wherein the wall and the support wall are connected by the connector.

[0034] Example 28. The device of example 27, wherein the distal ends of the walls are not connected and provide an opening to the volume.

[0035] Example 29. The device of Example 28, wherein the distal end of the support wall is not connected and provides an opening to the volume.

[0036] Example 30. An intravascular device comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A first tubular portion; a second tubular portion nested within the first tubular portion; at least one connector closing a proximal opening of the first tubular portion and a proximal opening of the second tubular portion at a connection region; The expandable body includes: The intravascular device, wherein the first tubular portion enters the connection region from a first direction and the second tubular portion enters the connection region from a second direction.

[0037] Example 31. A device as described in Example 30, wherein the first tubular portion and the second tubular portion are formed by a single tubular portion folded over at the connection region.

[0038] Example 32. An intravascular device comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A base and a wall extending from the base; a radiation source connected to the base; The intravascular device comprising the expandable body.

[0039] Example 33. The device described in Example 32, wherein when the expandable body is in the expanded configuration, the dose emanating from the outside of the expandable body and provided by the radiation source is less than 50 Gy.

[0040] Example 34. The device of any one of Examples 32-33, wherein the radiation source delivers radiation at a dose of 10-40 Gy at 0-1 mm from the outer surface of the source.

[0041] Example 35. The device of any one of Examples 32 to 34, wherein the radiation source delivers radiation at an initial rate of 500 to 1000 mGy / hour.

[0042] Example 36. A device described in any one of Examples 32 to 35, wherein the radiation source is positioned in a central region of the expandable body when the expandable body is in the expanded configuration.

[0043] Example 37. A device described in any one of Examples 32 to 35, wherein the radiation source is attached to the expandable body by a holder, the radiation source being attached to the holder, and the holder being attached to the body.

[0044] Example 38. The device of Example 37, wherein the source is mounted on the holder.

[0045] Example 39. A device described in any one of Examples 32 to 38, wherein the radiation source is at least partially held within the inner cavity of the holder.

[0046] Example 40. A device described in any one of Examples 32 to 39, wherein a portion of the base connected to the source is recessed into the wall.

[0047] Example 41. A device described in any one of Examples 32 to 40, wherein the expandable body includes an opening sized and shaped to allow the radiation source to be attached to the device.

[0048] Example 42. A device as described in Example 41, wherein the opening is an opening in a mesh of material forming at least a portion of the expandable body.

[0049] Example 43. A method for treating an aneurysm, comprising: placing an expandable body within the aneurysm at a predetermined location covering the aneurysm mouth; irradiating the aneurysm with a radiation source connected to the expandable body at a radiation level configured to stimulate the formation of a thrombus within the aneurysm and the growth of tissue across the aneurysm mouth; The method comprising:

[0050] Example 44. The method of Example 43, wherein the placing comprises delivering the expandable body into a blood vessel in a contracted configuration.

[0051] Example 45. The method of any one of Examples 43 to 44, wherein the placing includes expanding the expandable body within the aneurysm.

[0052] Example 46. The method of any one of Examples 44 to 45, wherein the delivering step includes applying pressure to a holder connected to the expandable device.

[0053] Example 47. The method of any one of Examples 43 to 46, comprising attaching a radiation source to the expandable device prior to deploying the device.

[0054] Example 48. The method of Example 47, comprising folding the expandable device before deploying the device and after attaching the radiation source.

[0055] Example 49. The method of any one of Examples 43 to 48, wherein the irradiating comprises irradiating a tissue region at the mouth of the aneurysm with a dose of 10 to 40 Gy.

[0056] Example 50 The method of Example 49, wherein the irradiating comprises irradiating tissue outside the aneurysm at a dose of less than 50 Gy.

[0057] Example 101. An intravascular device, comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A base and a wall extending from the base; a radiation source connected to the base; The intravascular device comprising the expandable body.

[0058] Example 102. The device described in Example 101, wherein the radiation source provides a dose of 10 to 40 Gy to a portion of the expandable body in the expanded configuration.

[0059] Example 103. A device described in any one of Examples 101 to 102, wherein when the expandable body is in the expanded configuration, the dose emanating from the outside of the expandable body and provided by the radiation source is less than 50 Gy.

[0060] Example 104. A device according to any one of Examples 101 to 103, wherein the radiation source delivers radiation at a dose of 10 to 40 Gy at a distance of 0 to 1 mm from the outer surface of the source.

[0061] Example 105. The device of any one of Examples 101 to 104, wherein the radiation source delivers radiation at a dose of 0.1 to 50 Gy at a distance of 0 to 1 mm from the outer surface of the source.

[0062] Example 106. The device of Examples 101-105, wherein the radiation source delivers radiation at a dose of 20-150 Gy at 0-1 mm from the outer surface of the source.

[0063] Example 107. The device of any one of Examples 104 to 106, wherein the radiation source irradiates at an initial rate of 500 to 1000 mGy / hour.

[0064] Example 108. The device of any one of Examples 104 to 106, wherein the radiation source delivers radiation at an initial rate of 25 to 500 mGy / hour.

[0065] Example 109. The device of any one of Examples 104 to 106, wherein the radiation source irradiates at an initial rate of 0.1 to 100 mGy / hour.

[0066] Example 110. A device described in any one of Examples 101 to 109, wherein the expandable body, in the expanded configuration, has sufficient elasticity to resist collapse within the aneurysm.

[0067] Example 111. A device described in any one of Examples 101 to 110, wherein the expandable body includes a support portion that reinforces one or both of a portion of the wall and the base.

[0068] Example 112. The device described in Example 111, wherein the support includes at least a portion recessed within the volume formed by the wall.

[0069] Example 113. A device described in any one of Examples 111 to 112, wherein the support includes at least a portion extending around one or both of the wall and the base.

[0070] Example 114. A device described in any one of Examples 111 to 113, wherein the support extends from a distal end of the wall.

[0071] Example 115. A device described in any one of Examples 111 to 113, wherein at least a portion of the expandable body has sufficient flexibility to at least partially conform to the internal shape of the aneurysm.

[0072] Example 116. A device described in any one of Examples 111 to 115, wherein the expandable body is elastically expandable into the expanded configuration.

[0073] Example 117. A device described in any one of Examples 111 to 116, wherein the radiation source is positioned in a central region of the expandable body when the expandable body is in the expanded configuration.

[0074] Example 118. A device described in any one of Examples 111 to 117, wherein the radiation source is attached to the expandable body by a holder, the radiation source being attached to the holder, and the holder being attached to the body.

[0075] Example 119. The device described in Example 118, wherein the radiation source is mounted on the holder.

[0076] Example 120. A device described in any one of Examples 111 to 119, wherein the radiation source is at least partially held within the inner cavity of the holder.

[0077] Example 121. A device described in any one of Examples 118 to 120, wherein the device includes a push wire, the push wire being connected to the holder.

[0078] Example 122. A device described in any one of Examples 101 to 121, wherein a portion of the base connected to the source is recessed into the wall.

[0079] Example 123. A device described in any one of Examples 101 to 122, wherein the wall is tubular.

[0080] Example 124. A device described in any one of Examples 101 to 123, wherein the expandable body is made of mesh.

[0081] Example 125. A device described in any one of Examples 101 to 124, wherein the expandable body includes an opening sized and shaped to allow the radiation source to be attached to the device.

[0082] Example 126. A device described in Example 125, wherein the opening is an opening in a mesh of material forming at least a portion of the expandable body.

[0083] Example 127. A device described in any one of Examples 101 to 126, comprising an upper portion at least partially enclosing a volume enclosed by the wall, the base portion being disposed at a proximal end of the expandable body, the wall extending distally from the base portion, and the upper portion being disposed at a distal portion of the wall.

[0084] Example 128. A device described in any one of Examples 101 to 127, wherein at least a portion of the expandable body comprises a double-layer mesh.

[0085] Example 129. A method for treating an aneurysm, comprising: placing an expandable body within the aneurysm at a predetermined location covering the aneurysm mouth; irradiating the aneurysm with a radiation source connected to the expandable body at a radiation level configured to stimulate the formation of a thrombus within the aneurysm and the growth of tissue across the aneurysm mouth; The method comprising:

[0086] Example 130. The method of Example 129, wherein the placing includes delivering the expandable body into a blood vessel in a contracted configuration.

[0087] Example 131. The method of any one of Examples 129 to 130, wherein the placing includes expanding the expandable body within the aneurysm.

[0088] Example 132. The method of any one of Examples 130 to 131, wherein the delivering step includes applying pressure to a holder connected to the expandable device.

[0089] Example 133. The method of any one of Examples 129 to 132, comprising attaching a radiation source to the expandable device prior to deploying the device.

[0090] Example 134. The method of Example 133, comprising folding the expandable device before deploying the device and after attaching the radiation source.

[0091] Example 135. The method of any one of Examples 129 to 134, wherein the irradiating comprises irradiating a tissue region at the mouth of the aneurysm with a dose of 10 to 40 Gy.

[0092] Example 136 The method of example 135, wherein the irradiating comprises irradiating tissue outside the aneurysm at a dose of less than 50 Gy.

[0093] Example 137. An intravascular device comprising: an expandable body having an expanded configuration and a contracted configuration, the expandable body in the expanded configuration having a convexly curved shape; A connector, The intravascular device, wherein the connector is attached to the expandable body and is recessed within the convex curved shape.

[0094] Example 138. A device described in Example 137, wherein the device comprises a support providing a bilayer on at least a portion of the expandable body.

[0095] Example 139. A device described in Example 138, wherein the support and the expandable body are connected by the connector.

[0096] Example 140. A device described in any one of Examples 137 to 139, wherein the expandable body is formed by a tubular structure whose proximal end is closed by the connector.

[0097] Example 141. The device comprises a support providing a bilayer on at least a portion of the expandable body; A device as described in Example 140, wherein the support is formed by a tubular structure whose proximal end is closed by the connector.

[0098] Example 142. A device described in any one of Examples 138 to 141, wherein one or both of the expandable body and the support include a mesh.

[0099] Example 143. The expandable body is coupled to the connector from a distal end of the connector; A device described in any one of Examples 138 to 142, wherein the support is coupled to the connector from a proximal end of the connector.

[0100] Example 144. A device described in any one of Examples 141 to 143, wherein the expandable body and the support are formed by a single tubular structure that is folded back to provide the expandable body and the support.

[0101] Example 145. An intravascular device comprising: A connector; An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A proximal end; A distal end. a wall connecting the proximal end and the distal end, the wall being connected to the connector disposed at the proximal end; the expandable body comprising: a support disposed within a volume defined by the walls, a support proximal end; a support distal end; The wall and a support wall extending from the connector at the proximal end of the support toward the distal end of the support; The support comprises: The intravascular device, wherein the wall and the support wall are connected only by the connector.

[0102] Example 146. A device as described in Example 145, wherein the distal ends of the walls are not connected and provide an opening to the volume.

[0103] Example 147. A device as described in Example 146, wherein the distal end of the support wall is not connected and provides an opening to the volume.

[0104] Example 148. An intravascular device, comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A first tubular portion; a second tubular portion nested within the first tubular portion; at least one connector closing a proximal opening of the first tubular portion and a proximal opening of the second tubular portion at a connection region; The expandable body includes: The intravascular device, wherein the first tubular portion enters the connection region from a first direction and the second tubular portion enters the connection region from a second direction.

[0105] Example 149. A device described in Example 148, wherein the first tubular portion and the second tubular portion are formed by a single tubular portion folded over at the connection region.

[0106] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.

[0107] Implementation of the method and / or system of the present invention may involve performing or completing selected tasks manually, automatically, or a combination thereof. Furthermore, depending on the actual instrumentation and implementation of the method and / or system of the present invention, some selected tasks could be performed by hardware, software, or firmware using an operating system, or a combination thereof.

[0108] For example, hardware for performing selected tasks according to embodiments of the present invention may be implemented as a chip or circuit. As software, selected tasks according to embodiments of the present invention may be implemented as a number of software instructions executed by a computer using any suitable operating system. In an exemplary embodiment of the present invention, one or more tasks according to exemplary embodiments of the methods and / or systems described herein are performed by a data processor, such as a computing platform for executing a number of instructions. Optionally, the data processor includes volatile memory for storing instructions and / or data, and / or non-volatile storage, e.g., a magnetic hard disk and / or removable media, for storing instructions and / or data. Optionally, a network connection is also provided. A display and / or a user input device, such as a keyboard or mouse, are also optionally provided.

[0109] Some embodiments of the present invention are herein described, by way of example only, with reference to the accompanying drawings, in which specific reference is made in detail to the drawings, it being stressed that the particulars shown are for the purpose of illustrating and discussing embodiments of the invention by way of example, and in this regard the description using the drawings will make apparent to those skilled in the art how embodiments of the invention may be practiced. [Brief description of the drawings]

[0110] [Figure 1] 1 is a simplified cross-sectional schematic diagram of an intravascular device system according to some embodiments of the present invention. [Diagram 2] 1 is a flow chart of a treatment method according to some embodiments of the present invention. [Diagram 3] 1 is a flow chart of a treatment method according to some embodiments of the present invention. [Figure 4A] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4B] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4C] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4D] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4E] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4F] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4G] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Figure 4H] 1A-1D are simplified schematic cross-sectional views illustrating an exemplary aneurysm treatment, according to some embodiments of the present invention. [Diagram 5]FIG. 1 is a simplified schematic cross-sectional view of an exemplary expandable device. [Figure 6] FIG. 1 is a simplified schematic cross-sectional view of an exemplary expandable device. [Figure 7] FIG. 1 is a simplified schematic cross-sectional view of an exemplary expandable device. [Figure 8] FIG. 1 is a simplified schematic cross-sectional view of an exemplary expandable device. [Figure 9] FIG. 1 is a simplified schematic cross-sectional view of an exemplary expandable device. [Figure 10] FIG. 1 is a simplified schematic cross-sectional view of an exemplary expandable device. [Figure 11] FIG. 1 is a simplified diagram of an expandable device according to some embodiments of the present invention. [Figure 12A] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention, viewed from a distal direction. [Figure 12B] FIG. 1 is a simplified schematic side view of an expandable device according to some embodiments of the present invention. [Figure 12C] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 12D] FIG. 1 is a simplified schematic top view of an expandable device according to some embodiments of the present invention, taken from a proximal direction. [Figure 12E] 1A-1D are simplified schematic cross-sectional views of expandable devices in a collapsed state according to some embodiments of the present invention. [Figure 12F] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Figure 12G] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 12H] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Figure 13A] A simplified schematic cross-sectional view of an expandable device 1302 according to some embodiments of the invention. [Figure 13B] A simplified schematic cross-sectional view of an expandable device 1302 according to some embodiments of the invention. [Figure 13C]A simplified schematic cross-sectional view of a portion of an expandable device according to some embodiments of the present invention. [Figure 14A] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 14B] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 14C] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 15A] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 15B] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 15C] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 16A] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 16B] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 17A] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 17B] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 18] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 19A] FIG. 2 is a simplified schematic diagram of a source holder according to some embodiments of the present invention. [Figure 19B] 1 is a simplified schematic diagram of a radiation source according to some embodiments of the present invention. [Figure 19C] 1 is a simplified schematic diagram of a radiation source connected to a source holder, according to some embodiments of the present invention. FIG. [Figure 20A] FIG. 2 is a simplified schematic diagram of a source holder according to some embodiments of the present invention. [Figure 20B] 1 is a simplified schematic diagram of a radiation source according to some embodiments of the present invention. [Figure 20C] 1 is a simplified schematic diagram of a radiation source connected to a source holder, according to some embodiments of the present invention. FIG. [Figure 21] 1 is a simplified schematic diagram of a radiation source according to some embodiments of the present invention. [Figure 22A] FIG. 2 is a simplified schematic diagram of a source holder according to some embodiments of the present invention. [Figure 22B] 1 is a simplified schematic diagram of a radiation source according to some embodiments of the present invention. [Figure 23] FIG. 1 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the present invention. [Figure 24] FIG. 1 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the present invention. [Diagram 25] FIG. 1 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the present invention. [Figure 26] FIG. 1 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the present invention. [Figure 27] 1A-1C are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 28] 1A-1C are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 29A] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 29B] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Figure 30A] FIG. 1 is a simplified schematic diagram of an expandable device according to some embodiments of the present invention. [Figure 30B] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Diagram 31] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Diagram 32] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Diagram 33] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Diagram 34] 1 is a simplified schematic cross-sectional view of an expandable device within an aneurysm, according to some embodiments of the present invention. [Diagram 35] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Diagram 36] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 37] 1A-1D are simplified schematic cross-sectional views of expandable devices according to some embodiments of the present invention. [Figure 38] 1 shows a table illustrating exemplary dose rates according to some embodiments of the present invention. [Figure 39A] 1 is a flowchart of a method according to some embodiments of the present invention. [Figure 39B] 1 is a simplified cross-sectional schematic diagram of an intravascular device system according to some embodiments of the present invention. [Figure 39C] 1 is a simplified cross-sectional schematic diagram of an intravascular device system according to some embodiments of the present invention. [Figure 40A] 1 is a simplified schematic cross-sectional view of a device according to some embodiments of the present invention. [Figure 40B] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 40C] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 41A] 1 is an image of a side view of a device according to some embodiments of the present invention. [Figure 41B] 1 is an image of a device according to some embodiments of the present invention. [Figure 42A] 1 is a simplified cross-sectional schematic diagram of a device during delivery to a treatment area, according to some embodiments of the present invention. [Figure 42B] 1 is a simplified cross-sectional schematic diagram of a device undergoing deployment in a treatment area, according to some embodiments of the present invention. [Figure 42C] 1 is a simplified schematic cross-sectional view of a device deployed in a treatment area, according to some embodiments of the present invention. [Fig.42D] 1 is an image of a device deployed in a treatment area according to some embodiments of the present invention. [Figure 42E] 1 is a simplified schematic cross-sectional view of a device deployed in a treatment area, according to some embodiments of the present invention. [Fig.42F] 1 is an image of a device deployed in a treatment area according to some embodiments of the present invention. [Figure 43A] 1 is a simplified schematic cross-sectional view of a device according to some embodiments of the present invention. [Figure 43B] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 43C] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 44A] 1 is an image of a side view of a device according to some embodiments of the present invention. [Figure 44B] 1 is an image of a device according to some embodiments of the present invention. [Figure 45A] 1 is a simplified cross-sectional schematic diagram of a device during delivery to a treatment area, according to some embodiments of the present invention. [Figure 45B] 1 is a simplified cross-sectional schematic diagram of a device undergoing deployment in a treatment area, according to some embodiments of the present invention. [Figure 45C] 1 is a simplified schematic cross-sectional view of a device deployed in a treatment area, according to some embodiments of the present invention. [Figure 45D] 1 is a simplified schematic cross-sectional view of a device deployed in a treatment area, according to some embodiments of the present invention. [Figure 45E] 1 is an image of a device deployed in a treatment area according to some embodiments of the present invention. [Figure 46A] 1 is a simplified cross-sectional schematic diagram of a device during delivery to a treatment area, according to some embodiments of the present invention. [Figure 46B]1 is a simplified cross-sectional schematic diagram of a device undergoing deployment in a treatment area, according to some embodiments of the present invention. [Figure 46C] 1 is a simplified schematic cross-sectional view of a device deployed in a treatment area, according to some embodiments of the present invention. [Figure 46D] 1 is an image of a device deployed in a treatment area according to some embodiments of the present invention. [Figure 47A] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 47B] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 47C] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 48A] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 48B] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 48C] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 49A] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 49B] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 50A] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 50B] 1 is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention. [Figure 51] 1 is a flowchart of a method according to some embodiments of the present invention. [Figure 52] 1 is an image of a portion of a device according to some embodiments of the present invention. [Diagram 53] 1 is a simplified schematic cross-sectional view of a device according to some embodiments of the present invention. [Figure 54]1 is an image of a portion of a device according to some embodiments of the present invention. [Figure 55] 5A-D are simplified schematic diagrams of portions of devices according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0111] The present invention, in some embodiments thereof, relates to the treatment of intravascular abnormalities, and more particularly, but not exclusively, to the treatment of aneurysms using expandable intravascular devices.

[0112] overview A broad aspect of some embodiments of the invention relates to the treatment of aneurysms using low level radiation to stimulate the formation of a thrombus within the aneurysm and / or the growth of neointima and / or vascular tissue at the aneurysm mouth to close the aneurysm. In some embodiments, a thrombus formed within the aneurysm is prevented from exiting the aneurysm mechanically, for example, by occlusion of the aneurysm. Optionally, some embodiments further reduce blood flow to and / or from the aneurysm, for example, by mechanical occlusion. In some embodiments, closure of the aneurysm is achieved without reducing blood flow to and / or from the aneurysm (e.g., at maximum arterial pressure).

[0113] In some embodiments, an expandable intravascular device is placed within the aneurysm and holds one or more radiation sources in a position that exposes the intraneuronal volume and / or aneurysm neck to appropriate radiation levels, while holding the sources at a distance away from healthy tissue.

[0114] In some embodiments, the device includes an expandable body having various expanded configurations associated with different aneurysm sizes. In some embodiments, the expandable body at least partially conforms to the size and / or shape of the aneurysm. In some embodiments, the device expandable body has a single relaxed expanded configuration, e.g., when not subjected to external forces from tissue and / or a delivery device.

[0115] In some embodiments, the expandable device, when placed within the aneurysm, exposes tissue at the aneurysm mouth ("neck") to a dose of 1-50 Gy, or 10-40 Gy, or a lower, higher, or intermediate dose or range (and / or doses described in this section of this document). In some embodiments, the device does not expose tissue outside the aneurysm to more than 50 Gy, or more than 100 Gy, or more than 20 Gy, or a lower, higher, or intermediate range or dose. In some embodiments, the only area of ​​the device that is exposed to a dose of more than 50 Gy (or more than 100 Gy, or more than 20 Gy, or a lower, higher, or intermediate range or dose) is the central (e.g., as defined elsewhere in this document) area(s) of the device that is associated only with the internal volume of the aneurysm and / or blood vessel and / or blood and / or thrombus when the device is within the aneurysm.

[0116] In some embodiments, a high radiation source is used, for example, where the radiation dose at the source surface (or less than 1 mm, or less than 0.5 mm from the source surface) is greater than 50 Gy, or greater than 100 Gy, or greater than 300 Gy, or between 300 Gy and 500 Gy, or a lower, higher, or intermediate source or range. In some embodiments, the high radiation source provides a dose of 100-500 Gy, or a lower, higher, or intermediate range or dose, between 0-1 mm from the outer surface of the source. In some embodiments, the high radiation source is positioned and / or shielded such that the dose at the neck of the device and / or the proximal end of the device, and / or the dose on the outside of the device (as described elsewhere in this document) is less than 50 Gy, or less than 100 Gy, or less than 20 Gy, or a lower, higher, or intermediate range or dose.

[0117] In some embodiments, the radiation dose at the aneurysm neck is affected by one or more of the following:

[0118] • Characteristics of the source including its size and / or shape and / or radioactivity.

[0119] The location of the source within the aneurysm relative to the neck, e.g., the distance from the source to the neck. In some embodiments, this is defined by the location of the source relative to the expandable body with respect to the expanded configuration of the device for a particular aneurysm.

[0120] - Shielding of the neck provided by the expandable body, where shielding is influenced by the material properties of the expandable body wire and / or in some embodiments the density of the mesh of the expandable device in relation to the expanded configuration of the device for a particular aneurysm.

[0121] - Shielding of the neck provided by additional shielding elements of the device, for example defined by the position and / or material properties of the element(s).

[0122] In some embodiments, the radiation dose outside the aneurysm is also affected by these factors, such as by one or more of the following:

[0123] • Characteristics of the source including its size and / or shape and / or radioactivity.

[0124] The location of the source within the aneurysm relative to the tissue portion(s) outside the aneurysm, e.g., the distance between them. In some embodiments, this is defined by the location of the source relative to the expandable body with respect to the expanded configuration of the device for a particular aneurysm.

[0125] Shielding of tissue outside the aneurysm provided by the expandable body, where shielding is influenced by the material properties of the expandable body wire and / or, in some embodiments, the density of the mesh of the expandable device in relation to the expanded configuration of the device for a particular aneurysm.

[0126] - Shielding of tissue outside the aneurysm provided by additional shielding elements of the device, for example defined by the location and / or material properties of the element(s).

[0127] In some embodiments, one or more of the source characteristics(s), location within the device, and shielding provided by the device are selected to provide a desired radiation dose at the aneurysm neck and outside the aneurysm, where in some embodiments one or more of the source shielding and location are selected for different aneurysm sizes. In some embodiments, one or more features are fixed and other feature(s) are selected to provide a desired dose. For example, in some embodiments, the expandable device structure and / or material properties are selected, and then the source and / or additional shielding element(s) (and / or location within the device) are selected to provide a desired radiation dose.

[0128] In some embodiments, the one or more radiation sources are elements attached to the expandable device. Alternatively or additionally, in some embodiments, one or more portions of the expandable body (e.g., of the mesh) are themselves radioactive, where in some embodiments, a portion(s) of the expandable device are treated, e.g., as described herein, to become the radiation source(s) (e.g., by one or more treatment methods as described elsewhere in this document).

[0129] In some embodiments, the material of the expandable device at least partially absorbs radiation emitted from the radiation source(s). In some embodiments, for example, at least a portion of the expandable device is placed at the wall of the aneurysm and / or in close proximity to the wall of the aneurysm (e.g., less than 0.1-1 mm, or less than 0.1-0.5 mm, or at a shorter, longer, or intermediate distance or range), and the expandable body, in some embodiments, functions to protect tissue outside the aneurysm from radiation emitted from the source. In some embodiments, the inner layer of the bilayer device (e.g., including the wall and the supporting wall) acts to reduce radiation emitted by the source to a level suitable for the region between the first layer proximal to the source of the bilayer and the second layer of the bilayer. In some embodiments, the number and / or density of layers of the expandable body are selected for different portions of the aneurysm. For example, in some embodiments, the source is less likely to be blocked by the expandable body in the region of the neck of the aneurysm. In some embodiments, the connection region (e.g., line of sight) from the source to the neck region is less obstructed than the region(s) connecting the source to other portions of the device, where in some embodiments less obstructed includes fewer layers of mesh (e.g., one layer instead of two), and / or mesh porosity, and / or positioning of the radiopaque element(s), such as the positioning of the marker(s), and / or the positioning of the connecting ring(s). In some embodiments, the shielding provided by the expandable body itself allows for the use of higher intensity sources and / or different type(s) of radiation, e.g., without (or with minimal) damage to healthy tissue and / or tissue outside the aneurysm.

[0130] In some embodiments, the shielding provided by the body of the device allows a single device to be used in a variety of applications, such as a device in which the source is located within the body of an expandable device, where the expandable body is expanded in a small aneurysm, which has higher shielding properties (e.g., associated with tighter packing of the mesh) that protect the tissue outside the aneurysm, and in some embodiments, the same device is used in a larger aneurysm, but the source is located further away from the tissue outside the aneurysm, balancing the reduced obstruction provided by the expanded, less dense mesh.

[0131] In some embodiments, the expandable intravascular device at least partially covers, and in some embodiments completely covers, the mouth of the aneurysm For example, if having a mesh, in some embodiments the pore size of the mesh is selected to prevent the exit of thrombus beyond a certain size from the aneurysm.

[0132] In exemplary embodiments, the aneurysm is a wide neck cerebral saccular aneurysm. In some embodiments, the aneurysm has an average and / or maximum dimension of 3-10 mm, and the maximum and / or average cross-sectional dimension of the aneurysm neck is 3-8 mm, or at least 1 mm, or at least 2 mm, or at least 3 mm, or at least 4 mm, or smaller, or larger, or intermediate sizes or ranges. In some embodiments, the aneurysm has a dome-to-neck ratio of less than 2, or 0.1-3, or a lower, higher, or intermediate range or ratio.

[0133] In some embodiments, the aneurysm is a large or giant aneurysm having a maximum and / or average dimension of 10-25 mm, or a lower, higher, or intermediate dimension or range, e.g., a dome-to-neck ratio of 0.1-3, or a lower, higher, or intermediate range or ratio.

[0134] In some embodiments, the aneurysm sac and / or aneurysm neck are exposed to low dose and / or low dose rate ionizing radiation, for example, as described herein below.

[0135] An aspect of some embodiments of the invention relates to an intravascular device that includes an expandable body having a wall and a base, with at least one radiation source connected to the body.

[0136] In some embodiments, the expandable body is provided separately from the radiation source(s), e.g., the radiation source is secured to the expandable body prior to placing the device in the blood vessel. A potential advantage is that the shelf life of the radiation source and the expandable body are decoupled and / or only the radiation source needs to be stored in a shielded container.

[0137] In some embodiments, an expandable intravascular device is delivered to the aneurysm and expanded within the volume of the aneurysm to position the radiation source within the aneurysm.

[0138] In some embodiments, when the device is expanded within the aneurysm, the base covers the mouth of the aneurysm, e.g., in some embodiments, the base and / or walls of the device in the expanded configuration are sized and / or shaped to cover the aneurysm.

[0139] In some embodiments, the expanded configuration of the device is oversized in one or more dimensions relative to the aneurysm. A potential benefit is that the force of the device on the aneurysm and / or the resulting friction and / or adhesion of the device against the aneurysm prevents migration of the device once expanded. A potential benefit of the force and / or friction between the device and the aneurysm is wounding and / or irritation to the aneurysm, which in some embodiments increases the rate of healing and / or treatment. In some embodiments, the oversizing is in one or more directions perpendicular to the plane of the aneurysm mouth and / or in the direction from the aneurysm mouth to the dome, a directional designation referred to herein with respect to the device as the proximal-distal direction and / or length of the expandable device. Additionally or alternatively, in some embodiments, the oversizing is in one or more directions parallel to the plane of the aneurysm volume and / or perpendicular to the proximal-distal direction of the device and / or parallel to the width and / or depth of the device.

[0140] In some embodiments, when the device is expanded within the aneurysm, the distal portion of the device adjacent and / or in contact with the aneurysm wall acts to hold the device in position over the aneurysm mouth of the aneurysm. In this case, for example, the contact of the distal portion of the device (e.g., with the aneurysm dome) is, in some embodiments, positioned by selecting a device that is oversized relative to the dimension(s) of the aneurysm, e.g., at the aneurysm neck, e.g., in the direction from the aneurysm neck to the dome. In some embodiments, the device is configured, e.g., such that the length of the device extending distally from the base positions the distal portion of the device at the wall of the aneurysm. Here, in some embodiments, the device is elastically expandable in the proximal-distal direction, and the relaxed length of the device is greater than the length of the aneurysm, e.g., the distance from the aneurysm mouth to the opposing inner wall of the aneurysm.

[0141] In some embodiments, the expandable body, when at least partially expanded and positioned within the aneurysm, sufficiently resists tissue forces on the expandable body to prevent collapse of the expandable body. In some embodiments, the base and / or walls are configured to resist collapse of the expandable device, for example under tissue forces of the aneurysm and / or surrounding tissue. In some embodiments, a thrombus formed within the aneurysm prevents collapse of the aneurysm and / or the expandable body. A potential benefit is a reduced likelihood of the device becoming dislodged from the aneurysm and / or of the aneurysm collapsing leaving an aneurysm neck. In some embodiments, the base and / or walls of the expandable body resist collapse onto the source of the aneurysm. A potential benefit is that healthy tissue surrounding the aneurysm is not irradiated at the radiation level selected for treatment of the aneurysm.

[0142] In some embodiments, one or more portions of the expandable body are sufficiently flexible that the expandable body at least partially conforms to the shape of the aneurysm. For example, in some embodiments, a portion(s) of the expandable body wall (e.g., distal portion(s)) at least partially conforms to the shape of the aneurysm. A potential benefit is a reduced likelihood of the device becoming dislodged from its position within the aneurysm.

[0143] In some embodiments, the expandable body of the device is self-expanding, e.g., elastically self-expands upon exiting (e.g., being pushed out of) the delivery catheter. In some embodiments, the elastic expansion force of the expandable body is sufficient to resist collapse of the expandable body, potentially reducing the likelihood of the device becoming dislodged from the aneurysm lumen.

[0144] In some embodiments, the expandable body is not self-expanding or is only partially self-expanding, in some embodiments, for example, the expandable is a balloon that is expanded, for example, by inflating a balloon disposed within the expandable body.

[0145] In some embodiments, the radiation source is connected to the expandable body such that when the expandable body is in a relaxed, expanded configuration (not subject to externally applied force(s)), the radiation source is located in a central region of the expandable body in one or more directions. In some embodiments, the radiation source is connected to the expandable body such that when the expandable body is disposed within an aneurysm, the radiation source is located in a central region of the aneurysm. For example, in some embodiments, the radiation source is connected to the expandable body such that when the expandable body is deployed within an aneurysm (optionally at least partially conforming to the shape of the aneurysm), the radiation source is located in a central region of the expandable body in one or more directions.

[0146] In some embodiments, the center of the radiation source is located within 5-80%, or 5-50%, or 5-20%, or a smaller, larger, or intermediate percentage or range of the center of the device volume. In some embodiments, the radiation source is located in one or more directions within a central region of the expandable structure. For example, in some embodiments, the radiation source (e.g., the center of a cross-section of the radiation source cut parallel to the base) is located centrally with respect to the base of the expandable device, e.g., within 5-80%, or 5-50%, or 5-20%, or a smaller, larger, or intermediate percentage or range of the center of the base. For example, in some embodiments, the radiation source (e.g., the center of a cross-section of the radiation source cut parallel to the wall) is located centrally with respect to the wall of the expandable device, e.g., within 5-80%, or 5-50%, or 5-20%, or a smaller, larger, or intermediate percentage or range of the center of the wall.

[0147] In an exemplary embodiment, the radiation source is connected to a holder attached to the expandable body. In some embodiments, the radiation source is connected to the holder just prior to using the device during treatment. A potential benefit is that the expiration date and / or lifespan of the radiation source is decoupled from that of the expandable body.

[0148] In some embodiments, the holder also provides mechanical support to the expandable body, hi some embodiments, the holder is used in delivery of the device, for example, intravascularly.

[0149] In some embodiments, one or more connections between the expandable body and other element(s) are located within the expandable body, e.g., within 80-99% or 80-95% of the center of the expandable body, including, for example, a connection between the expandable body and a holder and / or source and / or a connection between the expandable body and a portion of a delivery device, e.g., a push wire.

[0150] In some embodiments, a portion of the expandable body is at least partially recessed into a volume of the device defined by the walls of the device. For example, at least a portion of the base and / or at least a portion of the top of the expandable device is recessed into a lumen defined by the walls. In some embodiments, the recess is a portion of the device that includes one or more connectors. For example, a connector that holds a portion of the device closed, e.g., a base closure connector and / or a top closure connector. For example, a connector to a push wire and / or other delivery device part(s). For example, a connector to a radiation source and / or a radiation source holder.

[0151] In some embodiments, the recess in the portion where the source is connected (e.g., the base and / or top) moves the source connection closer to the center of the wall of the device. A potential advantage of the recessed source connection to the body is that there is less interruption of the source connection to the blood flow in the host vessel where the aneurysm is deforming.

[0152] In some embodiments, the connection of the expandable device to a delivery apparatus (eg, a push wire) is recessed into the device.

[0153] In exemplary embodiments, the connections for the source and the delivery device are in the same portion and / or region of the base, which in some embodiments is recessed into the expandable body.

[0154] In some embodiments, the expandable body includes a top portion. In some embodiments, the top portion extends from the wall and at least partially encloses a lumen formed by the wall. In some embodiments, the top portion is closed. In some embodiments, the top portion includes an opening, which in some embodiments provides access for attachment of a source to the expandable body, such as attachment to a base and / or attachment to a base via a holder attached to the base.

[0155] In some embodiments, one or more portions of the expandable structure are multi-layered. For example, in some embodiments, a portion of the base and / or top is recessed into a tubular structure defined by the wall. In some embodiments, the base and / or wall are surrounded (e.g., proximally) by a support structure. Potential advantages of a multi-layered structure include increased resilience of the structure to collapse and / or increased scaffolding to provide a surface for thrombus growth.

[0156] In some embodiments, the top is at least partially recessed into the volume represented by the wall. A potential benefit of a recessed base and / or a recessed top is, for example, increased resistance of the expandable device to compression in areas of the expandable body where the recess(es) reinforce (e.g., form a bilayer with) the wall of the device. In some embodiments, the increased resistance is to compression in a direction perpendicular to the central longitudinal axis of the wall (e.g., a tubular wall), e.g., radially for a cylindrical expandable body.

[0157] A potential benefit of the recess(es) is that the rate of thrombus formation within the aneurysm increases with the increased scaffolding provided by the recess(es).

[0158] In some embodiments, the recess(es) are formed by folding back material extending from the wall of the expandable device into a lumen defined by the wall. For example, a tubular structure forms the wall, and an end portion(s) of the wall is folded back into the tubular structure. In some embodiments, the folded back end(s) are not recessed, but extend outwardly around the wall. For example, mechanical reinforcement of the wall and / or a double layer of mesh providing scaffolding and / or restriction of blood flow, for example at the aneurysm mouth. In some embodiments, the folded back portion(s) and / or double layer portion(s) are not used in the base of the device, preventing additional material from blocking the aneurysm mouth from the emitted radiation. Alternatively, in some embodiments, the base includes two or more layers of mesh, for example formed by folding back material of the base and / or wall, with the folded back material extending to form the double layer portion. Potential benefits are increased restriction of blood flow and / or increased mechanical resilience.

[0159] In some embodiments, one or more portions of the expandable body are formed from a mesh, such as a wire mesh. In some embodiments, the mesh material is biocompatible and / or coated with a biocompatible material. In an exemplary embodiment, the wire mesh comprises Nitinol. In some embodiments, the pore size of the mesh is selected to reduce blood flow to the aneurysm and / or to prevent thrombus from leaking from within the aneurysm. Further exemplary details of mesh construction are described below in the section titled "Exemplary Expandable Body Materials."

[0160] In some embodiments, one or more portions of the expandable body include more than one mesh layer, e.g., a bilayer. Potential benefits of additional layers include increased mechanical resilience (e.g., related to resistance of the device to collapse), and / or reduced pore size, and / or increased scaffolding to provide a surface for thrombus growth within the aneurysm and / or a surface for endothelialization at the aneurysm neck. In some embodiments, the base portion is at least partially formed by a multi-layer mesh (e.g., a bilayer).

[0161] In some embodiments, the radiation source is attached to the expandable body by a holder. In some embodiments, the holder is formed of an ionizing radiation resistant material, such as an ionizing radiation resistant polymer, such as PEEK and / or polyimide. In some embodiments, the radiation source is disposed within a lumen of the holder, where in some embodiments, once the radiation source is placed within the lumen of the holder, the lumen is closed and / or contracted to prevent movement of the radiation source.

[0162] In some embodiments, the source is attached to the outside of the holder. In an exemplary embodiment, the source is stretched over the holder and the reaction force of the stretching holds the source to the holder.

[0163] In some embodiments, the holder extends distally from the base and the source is attached to the holder at a distal portion of the holder.

[0164] In some embodiments, the holder provides mechanical support to the intravascular device. For example, in some embodiments, delivery of the device is performed by applying pressure to the holder, e.g., via a push wire connected to the holder. In some embodiments, the holder is elongated. In some embodiments, the holder is axially flexible but resists deformation in the elongation direction of the holder. The potential axial flexibility and / or resistance to deformation in the elongation direction allows for delivery of the device, e.g., a collapsed device, through a delivery lumen (e.g., a catheter).

[0165] In some embodiments, the holder is directly connected to the expandable body, for example by welding, or by connecting (e.g., gluing, screwing) two holders together via a body disposed between them.

[0166] Alternatively or additionally, in some embodiments, the expandable body is attached to the holder by disposing a portion of the expandable body between the holder and the connector. In an exemplary embodiment, the connector is ring-shaped and is optionally radiopaque. In some embodiments, the connector is attached to the expandable body by one or more of crimping, gluing, welding, and quenching. In some embodiments, the connector is attached to the expandable body and the holder together, for example, by one or more of crimping, gluing, welding, and quenching. In an exemplary embodiment, the connector is quenched together onto the mesh of the expandable body and onto the holder.

[0167] In some embodiments, the expandable body is attached to the holder at one or more locations, for example, in some embodiments, both the expandable body base and the expandable body top are attached to the holder, for example, by separate connectors for the base and the ring.

[0168] In some embodiments, the walls and base are reinforced by a support (which in some embodiments includes an additional wall optionally connected to the base). In some embodiments, the support is proximal to the walls and base of the expandable body and optionally connected to a delivery device. Optionally, in some embodiments, the support is attached to a holder.

[0169] In some embodiments, the wall of the expandable device forms a tubular shape. In some embodiments, the cross-section of the tubular shape is constant along the length of the wall (e.g., varies by up to 10%, or 5%, or smaller, or larger, or intermediate percentages). In some embodiments, this cross-section is symmetrical about one or more axes, e.g., circular in some embodiments.

[0170] In some embodiments, the cross-section of the tubular shape varies along the length of the wall, e.g., increases in the distal direction, in which case, for example, the expansion device includes a sloping wall, e.g., having a frusto-conical shape extending from a base.

[0171] In some embodiments, the cross section of the tubular shape of the wall increases rapidly along the length of the wall, e.g., forming a flattened cup shape with the base, e.g., in some embodiments, the cross section of the wall at least doubles along the length of the wall, or increases by 1.5-50 times, or 5-20 times, or about 10 times.

[0172] In some embodiments, the expandable device is delivered by pressure applied to the push wire, and after delivery, the push wire is detached and removed. In some embodiments, removal of the push wire is performed by electrolytically weakening the connection between the push wire and the expandable device. In some embodiments, the push wire is conductive, and a current applied to the push wire acts to weaken the connection, allowing the push wire to be removed from the treatment site while leaving the expandable device in place. Alternatively or additionally, in some embodiments, separation of the push wire is performed via electrothermal weakening of the connection between the push wire and the expandable device, e.g., where a current is used to heat the connection to weaken it. Alternatively or additionally, in some embodiments, removal of the push wire from the device includes a mechanical release, e.g., changing the tension of the elongated element (in some embodiments, the push wire) to remove the push wire from the expandable device. In some embodiments, the push wire is attached to a holder. In this case, in some embodiments, the holder is electrically insulating, potentially preventing electrical stimulation (e.g., from affecting the expandable device and / or adjacent and / or surrounded tissue due to electrolytic and / or electrothermal isolation of the push wires).

[0173] In some embodiments, the device is configured to be reattached to the apparatus for movement of the device, e.g., reattached to the push wire. In some embodiments, the device is withdrawn and / or repositioned, e.g., after reattachment of the push wire. In some embodiments, the push wire is magnetically attached to and / or detached from the expandable body, e.g., via a holder.

[0174] In some embodiments, the radiation source is removed from within the aneurysm, e.g., after treatment is completed, e.g., leaving a portion(s) of the expandable body of the device in place, e.g., in some embodiments, the holder is reattached to the push wire and the holder and source are removed from the device.

[0175] In some embodiments, the expandable device includes one or more radiopaque markers. For example, in some embodiments, one or more connectors (e.g., connecting rings) include a radiopaque material. For example, in some embodiments, the mesh of the device itself includes a radiopaque material.

[0176] In some embodiments, the radiation source is positioned relative to the radiopaque marker(s) such that the marker(s) do not shield radiation from being emitted in a particular direction(s) and / or in a particular region(s) of the tissue. For example, in some embodiments, a marker (e.g., a ring attachment) is positioned distal to the radiation source, potentially preventing the marker from shielding the aneurysm neck region from radiation.

[0177] In some embodiments, the radiation source is directionally shielded in one or more directions, e.g., to prevent radiation from reaching sensitive tissue outside the aneurysm, such as the optic nerve, In some embodiments, the shielding portion(s) form a radiopaque marker, e.g., allowing the user to potentially verify the correct positioning of the device and / or shielding.

[0178] In some embodiments, the pore size of one or more portions of the device is selected to allow for the insertion of additional element(s), such as for the insertion of an aneurysm treatment coil(s) as is known in the art.

[0179] Although the devices and methods are described with respect to treating aneurysms, in some embodiments, the devices and / or methods described herein are used to treat other tissues, such as to close a lumen(s) in other body parts, such as for closing the left atrial appendage.

[0180] In some embodiments, the devices described herein do not include a radiation source(s). For example, in some embodiments, the structures described are used for treatments that do not use a radiation source. In some embodiments, a device is deployed that includes a radiation source, and the source is later removed, e.g., leaving the device in place. In some embodiments, a device is deployed without a radiation source.

[0181] Optionally, in some embodiments, after a period of treatment, one or more radiation sources are coupled to the device, e.g., a device that is initially devoid of radiation source(s). In some embodiments, removal and / or addition of radiation source(s) is based on a clinical evaluation of the effectiveness of the treatment and / or is predetermined in the treatment plan.

[0182] A broad aspect of some embodiments of the invention relates to treating aneurysms by deploying an expandable device within the aneurysm. In some embodiments, the device has a dual layer (e.g., a body layer and a support layer) that covers the mouth of the aneurysm when the device is deployed. In some embodiments, one or both layers are formed of a mesh, e.g., a wire mesh.

[0183] In some embodiments, the base and wall form a curved surface that is presented to the blood flow of the blood vessel(s) containing the aneurysm when the device is deployed within the aneurysm, hi some embodiments, the second layer of the bilayer is provided by a support.

[0184] In some embodiments, the distal portions of the support and the body are not connected, and / or the support and the body are only connected at a connection region. A potential advantage is, for example, that in some embodiments, the support and the body can transition through a transition and move relative to each other, facilitating delivery through a vessel (e.g., a tortuous vessel).

[0185] In some embodiments, the device includes an expandable body having various expanded configurations associated with different aneurysm sizes. In some embodiments, the expandable body at least partially conforms to the size and / or shape of the aneurysm. In some embodiments, the device expandable body has a single relaxed expanded configuration, e.g., when not subjected to external forces from tissue and / or a delivery device.

[0186] In some embodiments, the expandable intravascular device at least partially covers, and in some embodiments completely covers, the mouth of the aneurysm For example, if having a mesh, in some embodiments the pore size of the mesh is selected to prevent the exit of thrombus beyond a certain size from the aneurysm.

[0187] In exemplary embodiments, the aneurysm is a wide neck cerebral saccular aneurysm. In some embodiments, the aneurysm has an average and / or maximum dimension of 3-10 mm, and the maximum and / or average cross-sectional dimension of the aneurysm neck is 3-8 mm, or at least 1 mm, or at least 2 mm, or at least 3 mm, or at least 4 mm, or smaller, or larger, or intermediate sizes or ranges. In some embodiments, the aneurysm has a dome-to-neck ratio of less than 2, or 0.1-3, or a lower, higher, or intermediate range or ratio.

[0188] In some embodiments, the aneurysm is a large or giant aneurysm having a maximum and / or average dimension of 10-25 mm, or a lower, higher, or intermediate dimension or range, e.g., a dome-to-neck ratio of 0.1-3, or a lower, higher, or intermediate range or ratio.

[0189] In some embodiments, when the device is expanded within the aneurysm, the base covers the aneurysm mouth, e.g., in some embodiments, the base and / or walls of the device in the expanded configuration are sized and / or shaped to cover the aneurysm.

[0190] In some embodiments, the expanded configuration of the device is oversized in one or more dimensions relative to the aneurysm. A potential benefit is that the force of the device on the aneurysm and / or the resulting friction and / or adhesion of the device against the aneurysm prevents migration of the device once expanded. A potential benefit of the force and / or friction between the device and the aneurysm is wounding and / or irritation to the aneurysm, which in some embodiments increases the rate of healing and / or treatment. In some embodiments, the oversizing is in one or more directions perpendicular to the plane of the aneurysm mouth and / or in the direction from the aneurysm mouth to the dome, a directional designation referred to herein with respect to the device as the proximal-distal direction and / or length of the expandable device. Additionally or alternatively, in some embodiments, the oversizing is in one or more directions parallel to the plane of the aneurysm volume and / or perpendicular to the proximal-distal direction of the device and / or parallel to the width and / or depth of the device.

[0191] In some embodiments, when the device is expanded within the aneurysm, the distal portion of the device adjacent and / or in contact with the aneurysm wall acts to hold the device in position over the aneurysm mouth of the aneurysm. In this case, for example, the contact of the distal portion of the device (e.g., with the aneurysm dome) is, in some embodiments, positioned by selecting a device that is oversized relative to the dimension(s) of the aneurysm, e.g., at the aneurysm neck, e.g., in the direction from the aneurysm neck to the dome. In some embodiments, the device is configured, e.g., such that the length of the device extending distally from the base positions the distal portion of the device at the wall of the aneurysm. Here, in some embodiments, the device is elastically expandable in the proximal-distal direction, and the relaxed length of the device is greater than the length of the aneurysm, e.g., the distance from the aneurysm mouth to the opposing inner wall of the aneurysm.

[0192] In some embodiments, the expandable body, when at least partially expanded and positioned within the aneurysm, sufficiently resists tissue forces on the expandable body to prevent collapse of the expandable body. In some embodiments, the base and / or walls are configured to resist collapse of the expandable device, for example under tissue forces of the aneurysm and / or surrounding tissue. In some embodiments, a thrombus formed within the aneurysm prevents collapse of the aneurysm and / or the expandable body. A potential benefit is a reduced likelihood of the device becoming dislodged from the aneurysm and / or of the aneurysm collapsing leaving an aneurysm neck. In some embodiments, the base and / or walls of the expandable body resist collapse onto the source of the aneurysm. A potential benefit is that healthy tissue surrounding the aneurysm is not irradiated at the radiation level selected for treatment of the aneurysm.

[0193] In some embodiments, one or more portions of the expandable body are sufficiently flexible that the expandable body at least partially conforms to the shape of the aneurysm. For example, in some embodiments, a portion(s) of the expandable body wall (e.g., distal portion(s)) at least partially conforms to the shape of the aneurysm. A potential benefit is a reduced likelihood of the device becoming dislodged from its position within the aneurysm.

[0194] In some embodiments, the expandable body of the device is self-expanding, e.g., elastically self-expands upon exiting (e.g., being pushed out of) the delivery catheter. In some embodiments, the elastic expansion force of the expandable body is sufficient to resist collapse of the expandable body, potentially reducing the likelihood of the device becoming dislodged from the aneurysm lumen.

[0195] In some embodiments, the expandable body is not self-expanding or is only partially self-expanding, in some embodiments, for example, the expandable is a balloon that is expanded, for example, by inflating a balloon disposed within the expandable body.

[0196] In some embodiments, one or more connections between the expandable body and other element(s) are located within the expandable body, e.g., within 80-99% or 80-95% of the center of the expandable body, including, for example, a connection between the expandable body and a holder and / or source and / or a connection between the expandable body and a portion of a delivery device, e.g., a push wire.

[0197] In some embodiments, a portion of the expandable body is at least partially recessed into a volume of the device defined by the walls of the device. For example, at least a portion of the base and / or at least a portion of the top of the expandable device is recessed into a lumen defined by the walls. In some embodiments, the recess is a portion of the device that includes one or more connectors. For example, a connector that holds a portion of the device closed, e.g., a base closure connector and / or a top closure connector. For example, a connector to a push wire and / or other delivery device part(s). For example, a connector to a radiation source and / or a radiation source holder.

[0198] In some embodiments, the recess in the portion where the source is connected (e.g., the base and / or top) moves the source connection closer to the center of the wall of the device. A potential advantage of the recessed source connection to the body is that there is less interruption of the source connection to the blood flow in the host vessel where the aneurysm is deforming.

[0199] In some embodiments, the connection of the expandable device to a delivery apparatus (eg, a push wire) is recessed into the device.

[0200] In some embodiments, the expandable body includes a top portion. In some embodiments, the top portion extends from the wall and at least partially encloses a lumen formed by the wall. In some embodiments, the top portion is closed. In some embodiments, the top portion includes an opening, which in some embodiments provides access for attachment of a source to the expandable body, such as attachment to a base and / or attachment to a base via a holder attached to the base.

[0201] In some embodiments, one or more portions of the expandable structure are multi-layered. For example, in some embodiments, a portion of the base and / or top is recessed into a tubular structure defined by the wall. In some embodiments, the base and / or wall are surrounded (e.g., proximally) by a support structure. Potential advantages of a multi-layered structure include increased resilience of the structure to collapse and / or increased scaffolding to provide a surface for thrombus growth.

[0202] In some embodiments, the top is at least partially recessed into the volume represented by the wall. A potential benefit of a recessed base and / or a recessed top is, for example, increased resistance of the expandable device to compression in areas of the expandable body where the recess(es) reinforce (e.g., form a bilayer with) the wall of the device. In some embodiments, the increased resistance is to compression in a direction perpendicular to the central longitudinal axis of the wall (e.g., a tubular wall), e.g., radially for a cylindrical expandable body.

[0203] A potential benefit of the recess(es) is that the rate of thrombus formation within the aneurysm increases with the increased scaffolding provided by the recess(es).

[0204] In some embodiments, the recess(es) are formed by folding back material extending from the wall of the expandable device into a lumen defined by the wall. For example, a tubular structure forms the wall, and an end portion(s) of the wall is folded back into the tubular structure. In some embodiments, the folded back end(s) are not recessed, but extend outwardly around the wall. For example, mechanical reinforcement of the wall and / or a double layer of mesh providing scaffolding and / or restriction of blood flow, for example at the aneurysm mouth. In some embodiments, the folded back portion(s) and / or double layer portion(s) are not used in the base of the device, preventing additional material from blocking the aneurysm mouth from the emitted radiation. Alternatively, in some embodiments, the base includes two or more layers of mesh, for example formed by folding back material of the base and / or wall, with the folded back material extending to form the double layer portion. Potential benefits are increased restriction of blood flow and / or increased mechanical resilience.

[0205] In some embodiments, one or more portions of the expandable body are formed from a mesh, such as a wire mesh. In some embodiments, the mesh material is biocompatible and / or coated with a biocompatible material. In an exemplary embodiment, the wire mesh comprises Nitinol. In some embodiments, the pore size of the mesh is selected to reduce blood flow to the aneurysm and / or to prevent thrombus from leaking from within the aneurysm. Further exemplary details of mesh construction are described below in the section titled "Exemplary Expandable Body Materials."

[0206] In some embodiments, one or more portions of the expandable body include more than one mesh layer, e.g., a bilayer. Potential benefits of additional layers include increased mechanical resilience (e.g., related to resistance of the device to collapse), and / or reduced pore size, and / or increased scaffolding to provide a surface for thrombus growth within the aneurysm and / or a surface for endothelialization at the aneurysm neck. In some embodiments, the base portion is at least partially formed by a multi-layer mesh (e.g., a bilayer).

[0207] In some embodiments, the holder provides mechanical support to the intravascular device. For example, in some embodiments, delivery of the device is performed by applying pressure to the holder, e.g., via a push wire connected to the holder. In some embodiments, the holder is elongated. In some embodiments, the holder is axially flexible but resists deformation in the elongation direction of the holder. The potential axial flexibility and / or resistance to deformation in the elongation direction allows for delivery of the device, e.g., a collapsed device, through a delivery lumen (e.g., a catheter).

[0208] In some embodiments, the holder is directly connected to the expandable body, for example by welding, or by connecting (e.g., gluing, screwing) two holders together via a body disposed between them.

[0209] Alternatively or additionally, in some embodiments, the expandable body is attached to the holder by disposing a portion of the expandable body between the holder and the connector. In an exemplary embodiment, the connector is ring-shaped and is optionally radiopaque. In some embodiments, the connector is attached to the expandable body by one or more of crimping, gluing, welding, and quenching. In some embodiments, the connector is attached to the expandable body and the holder together, for example, by one or more of crimping, gluing, welding, and quenching. In an exemplary embodiment, the connector is quenched together onto the mesh of the expandable body and onto the holder.

[0210] In some embodiments, the expandable body is attached to the holder at one or more locations, for example, in some embodiments, both the expandable body base and the expandable body top are attached to the holder, for example, by separate connectors for the base and the ring.

[0211] In some embodiments, the walls and base are reinforced by a support (which in some embodiments includes an additional wall optionally connected to the base). In some embodiments, the support is proximal to the walls and base of the expandable body and optionally connected to a delivery device. Optionally, in some embodiments, the support is attached to a holder.

[0212] In some embodiments, the wall of the expandable device forms a tubular shape. In some embodiments, the cross-section of the tubular shape is constant along the length of the wall (e.g., varies by up to 10%, or 5%, or smaller, or larger, or intermediate percentages). In some embodiments, this cross-section is symmetrical about one or more axes, e.g., circular in some embodiments.

[0213] In some embodiments, the cross-section of the tubular shape varies along the length of the wall, e.g., increases in the distal direction, in which case, for example, the expansion device includes a sloping wall, e.g., having a frusto-conical shape extending from a base.

[0214] In some embodiments, the cross section of the tubular shape of the wall increases rapidly along the length of the wall, e.g., forming a flattened cup shape with the base, e.g., in some embodiments, the cross section of the wall at least doubles along the length of the wall, or increases by 1.5-50 times, or 5-20 times, or about 10 times.

[0215] In some embodiments, the expandable device is delivered by pressure applied to the push wire, and after delivery, the push wire is detached and removed. In some embodiments, removal of the push wire is performed by electrolytically weakening the connection between the push wire and the expandable device. In some embodiments, the push wire is conductive, and a current applied to the push wire acts to weaken the connection, allowing the push wire to be removed from the treatment site while leaving the expandable device in place. Alternatively or additionally, in some embodiments, separation of the push wire is performed via electrothermal weakening of the connection between the push wire and the expandable device, e.g., where a current is used to heat the connection to weaken it. Alternatively or additionally, in some embodiments, removal of the push wire from the device includes a mechanical release, e.g., changing the tension of the elongated element (in some embodiments, the push wire) to remove the push wire from the expandable device. In some embodiments, the push wire is attached to a holder. In this case, in some embodiments, the holder is electrically insulating, potentially preventing electrical stimulation (e.g., from affecting the expandable device and / or adjacent and / or surrounded tissue due to electrolytic and / or electrothermal isolation of the push wires).

[0216] In some embodiments, the device is configured to be reattached to the apparatus for movement of the device, e.g., reattached to the push wire. In some embodiments, the device is withdrawn and / or repositioned, e.g., after reattachment of the push wire. In some embodiments, the push wire is magnetically attached to and / or detached from the expandable body, e.g., via a holder.

[0217] In some embodiments, the expandable device includes one or more radiopaque markers. For example, in some embodiments, one or more connectors (e.g., connecting rings) include a radiopaque material. For example, in some embodiments, the mesh of the device itself includes a radiopaque material.

[0218] In some embodiments, the pore size of one or more portions of the device is selected to allow for the insertion of additional element(s), such as for the insertion of an aneurysm treatment coil(s) as is known in the art.

[0219] An aspect of some embodiments of the present invention relates to a low delivery profile (also referred to herein as "crimp profile") dual layer aneurysm treatment device.

[0220] wherein the maximum cross-sectional area (e.g., diameter) of the device when crimped (e.g., within a delivery catheter) is 200-1400 μm, or 300-1000 μm, or 300-700 μm, or a shorter, longer, or intermediate distance or range. In some embodiments, the minimum delivery profile of the device is defined by the cross-sectional area of ​​the connection region of the device, and optionally the layer thickness(es) of one or both of the bilayers, wherein in some embodiments, the maximum cross-sectional dimension of the connection region is 100-700 μm, or 200-500 μm, or a smaller, smaller, larger, or intermediate distance or range. In some embodiments, the layer thickness of one or more layers of the device is 50-200 μm, or 50-150 μm, or 50-100 μm, or a smaller, larger, or intermediate distance or range. In some embodiments, a bilayer device has at most one perimeter layer of device mesh material (eg, body layer and / or support layer material) in the connection region of the device when the device is in the crimped configuration.

[0221] In some embodiments, the support portion(s) of the device extend in a different direction from the connection region than the body portion(s) of the device, hi some embodiments, the body portion (e.g., but not the support portion) surrounds the connection region when in the crimped configuration.

[0222] In some embodiments, the bilayer is formed by folding a single section of tubing one or more times to form the support portion and the body portion. In some embodiments, a single end of the section of tubing is connected at a connection region. In some embodiments, the device is not bent (e.g., not bent around the connection region) and / or folded when in the crimped configuration, and in some embodiments, the connection region is not laterally bounded by the body and / or support material.

[0223] In some embodiments, the layers of the bilayer device can move relative to each other. For example, in some embodiments, the body region and the support region are only connected at a single connection region. For example, in some embodiments, the layers are formed using different tubular sections. A potential benefit is lower porosity (or higher coverage) of the device for a given crimp profile (e.g., the portion(s) of the device that closes the entrance to the aneurysm). A potential benefit is improved reliability of expansion of the device after crimping.

[0224] An aspect of some embodiments of the invention relates to an intravascular device having a double layer, where the layers are connected to each other at a single connection area and / or the distal ends of the layers of the device are not connected, where in some embodiments the single connection area is located at a proximal portion of the device, where in some embodiments the first layer has a base and a wall and the second layer has a base and a wall, where the distal ends of the walls of the first layer and the distal ends of the walls of the second layer are not connected to each other, where in some embodiments one or both of the first layer and the second layer are open, where there is no structure present that closes and / or reduces the area of ​​the distal opening(s) defined by the walls of the layers.

[0225] An aspect of some embodiments of the present invention relates to the ends of portions of a mesh device.

[0226] In some embodiments, the distal edge portion(s) of the device is a free mesh, e.g., it is not connected to other element(s) and / or extends such that it may contact tissue (e.g., as opposed to being forced into the volume of the device and / or held by a connector). In some embodiments, at least a portion of the ends of the fibers of the mesh, e.g., the tips of the ends of the mesh, are blunted. A potential benefit is that the risk of the ends causing trauma to tissue is reduced.

[0227] In some embodiments, blunting is accomplished by welding and / or coating the tip, hi some embodiments, only a portion of the tip is blunted, such as a peripheral portion, e.g., an outer tip that extends further from the body of the device than the other tips.

[0228] In some embodiments, the mesh filaments are interconnected. The potential (e.g., crossed wire) connections of the mesh increase the radial resistance and / or strength of the device and / or prevent delamination of the mesh (e.g., mesh weave). In some embodiments, the connections of the wires of the mesh are made by welding and / or adhesives. In some embodiments, the connections are made to edge regions of the mesh, e.g., areas with a higher risk of delamination. For example, to the distal 0.1-3 mm, or 0.1-1 mm, or areas including shorter, longer, or intermediate distances or ranges.

[0229] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0230] Example System FIG. 1 is a simplified cross-sectional schematic diagram of an intravascular device system 100 according to some embodiments of the present invention.

[0231] In some embodiments, the system 100 includes an expandable intravascular device 102 (also referred to herein as an "expandable device" or "intravascular device").

[0232] In some embodiments, the expandable device 102 has an expandable body 108, where the expandable body 108 has a distal end 118 and a proximal end 114.

[0233] In some embodiments, the body 108 includes a wall 110 and a base 116 .

[0234] In an exemplary embodiment, the expandable body 108 is formed at least in part by a mesh, shown in dashed lines in Figure 1. In some embodiments, the holes in the mesh are sized to restrict the flow of blood through the mesh and / or to prevent leakage of blood clots (e.g., above a certain size) from within the device lumen 112.

[0235] In some embodiments, one or more portions of the expandable body 108 are formed from a multi-layer (e.g., double-layer) mesh, for example, as shown by the double-layer dashed lines in Figure 1. Potential benefits of a double layer include increasing the resilience of the expandable body to collapse and / or increasing the inhibition of the migration of material (e.g., blood and / or clots) into and / or from outside the aneurysm.

[0236] In some embodiments, the lumen 112 defined by the wall 110 is closed (e.g., at the proximal end 114 of the body) by the base 116. Alternatively or additionally, the distal end 118 of the lumen 112 is at least partially closed (e.g., as described and / or illustrated elsewhere herein, e.g., with respect to Figures 6, 7, 8, 10, 17A-17B).

[0237] In some embodiments, the radiation source 104 (also referred to herein as the term "source") is coupled to the expandable device 102, for example, by a holder 106. Alternatively or additionally, in some embodiments, the source 104 is attached directly to the body 108, for example, by one or more of welding a mesh of the body 108 to the source 104, crimping the body 108 to the source 104, or gluing the body 108 to the source 104.

[0238] In some embodiments, the holder 106 is elongated and extends distally from the base 116 and positions the source 104 at a distance 103, e.g., 0-10 mm, or 0.1-5 mm, or 0.1-3 mm, or 0.5-15 mm, or 1-1.5 mm, or a shorter, longer, or intermediate range or distance. In some embodiments, the holder 106 and / or the source 104 are centrally positioned relative to the base 116 and / or the expandable body 108, e.g., within 5-80%, or 5-50%, or 5-20% of the center of the base 116, or a smaller, greater, or intermediate percentage or range. For example, the distance 101 is 0.1 mm to 15 mm, or a smaller, greater, or intermediate distance or range.

[0239] In some embodiments, the expandable system 100 includes a delivery and / or positioning apparatus 120. In some embodiments, the apparatus 120 includes an elongate element 122 that is coupled to the expandable device 102. In some embodiments, the elongate element 122 is a push wire. Optionally, in some embodiments, a connector 124 connects the push wire 122 to the expandable device 102. In an exemplary embodiment, the push wire 122 is connected (directly and / or via the connector 124) to the source mount 106.

[0240] Example method FIG. 2 is a flow chart of a treatment method according to some embodiments of the present invention.

[0241] The flowchart generally describes a method for treating an aneurysm, although in some embodiments it relates to the treatment of other tissue structure(s), such as vascular structure(s), and in an exemplary embodiment, to the treatment of the left atrial appendage (LAA).

[0242] In some embodiments, at 200, a patient is diagnosed, for example by a physician. In some embodiments, one or more types of measurements are collected from the patient, for example imaging (e.g., one or more of x-ray, CT, MRI, ultrasound, nuclear imaging) of a vascular anomaly (e.g., aneurysm) and / or vascular structure (e.g., left atrial appendage). In some embodiments, the measurements include the location and / or size and / or shape of the treatment site (e.g., left atrial appendage), including, for example, the aneurysm to be treated.

[0243] At 201, optionally, in some embodiments, an intravascular device is selected, where in some embodiments the selection is based on diagnostic results including, for example, measurements. For example, in some embodiments, the size and / or shape of the expandable body of the device is selected based on measurements (e.g., size and / or shape measurements) of the vascular region to be treated (e.g., an aneurysm, e.g., the left atrial appendage LAA).

[0244] In some embodiments, the size and / or shape of the expandable body (including, e.g., the size and / or shape of the base and / or walls of the device) is selected so that the expandable body covers the opening of the treatment site (e.g., the aneurysm mouth of an aneurysm, e.g., the LAA ostium), e.g., covering at least 50-95%, or at least 80-90%, or at least 90%, or a lower, higher, or intermediate percentage or range of the opening area.

[0245] In some embodiments, the length of the device is selected such that when the device is expanded within the aneurysm (or LAA), the device extends from the apex of the aneurysm (or LAA) to the aneurysm mouth of the aneurysm, such that the size and / or shape of the device holds the proximal portion (e.g., including the base of the expandable device) in place to close the aneurysm mouth of the aneurysm (or LAA).

[0246] In some embodiments, the size and / or shape of the expandable body in the expanded relaxed configuration is selected such that the expandable body within the aneurysm is larger in one or more directions than the aneurysm mouth of the aneurysm, In some embodiments, the oversizing and / or elastic relaxability force is selected to provide sufficient force between the device and the aneurysm wall to hold the device in place within the aneurysm (or LAA) (e.g., a force outward from the center of the device, e.g., a radial force).

[0247] In some embodiments, the radiation source of the intravascular device is selected. The radiation source is selected based on, for example, the size and / or shape and / or type of the aneurysm. In some embodiments, for example, a source with a higher dose and / or higher dose rate is selected for larger aneurysms. In some embodiments, the radiation source includes, for example, two or more elements, where the radioactive elements are positioned in different regions of the expandable structure and / or aneurysm (e.g., including one or more features shown in and / or described with respect to FIGS. 29A-B and / or 30A-B). Here, in some embodiments, the placement of the radioactive elements is selected based on the size and / or shape and / or type of the aneurysm (or LAA) to be treated.

[0248] In some embodiments, directional shielding of the radiation source is selected, for example to prevent radiation exposure outside of a particular tissue, such as an aneurysm, for example the optic nerve, In some embodiments, a shielding element is selected, which is optionally attached to the device and / or delivered through a catheter for positioning, for example after the device is in place.

[0249] In some embodiments, the selection is made from a kit that includes a variety of expandable bodies (e.g., those described with respect to Figures 12A-12F) and / or a variety of radiation sources. In some embodiments, once a device is selected, the selected radiation source is attached to the selected expandable body.

[0250] In some embodiments, at 202, a radiation source is coupled to the expandable intravascular device.

[0251] Here, the expandable device includes, for example, one or more features shown in Figures 1, 4A-4H, 5-10, 11, 12A-12H, 13A-13C, 14A-14C, 15A-15B, 16A-16B, and 17A-17B and / or described with respect to one or more of the intravascular devices of Figures 1, 4A-4H, 5-10, 11, 12A-12H, 13A-13C, 14A-14C, 15A-15B, 16A-16B, and 17A-17B.

[0252] Here, the combination of radiation sources includes one or more features shown in and / or described with respect to one or more of Figures 11, 19A-19C, 20A-20C, 21, 22A-22B, and 23-26.

[0253] In some embodiments, the radiation source(s) are attached to the expandable device using an attachment tool, which in some embodiments allows a user to attach the radiation source to the expandable device without directly contacting the source and / or device, potentially maintaining sterility of the device and / or protecting the user from radiation exposure.

[0254] At 203, optionally, in some embodiments, the expandable device is connected to one or more portions of a delivery apparatus, such as a push wire. Alternatively, in some embodiments, the expandable device is provided pre-attached to the push wire and / or delivery apparatus (e.g., prior to coupling of the radiation source in step 200).

[0255] At 204, optionally in some embodiments, the expandable device is compressed. Alternatively, in some embodiments, the expandable device is provided in a pre-compressed state, for example, where a radiation source is coupled to the compressed device.

[0256] In some embodiments, the device is loaded into a delivery catheter at 206. In some embodiments, steps 204 and 206 are combined and compression is achieved at least in part to position the expandable device within the delivery catheter, for example, by pulling the expandable device into the catheter and / or by placing the catheter over the expandable device.

[0257] At 207, optionally, in some embodiments, wounding of tissue is performed at the aneurysm site. For example, wounding to the aneurysm neck and / or the aneurysm sac. In some embodiments, the wounding is mechanical. Alternatively or additionally, the wounding is chemical, e.g., by chemical agent(s). In an exemplary embodiment, the expandable device system is moved to provide a frictional wound to the aneurysm neck, where the expandable device itself, and / or the push wire, and / or other portion(s) of the expandable device delivery apparatus are moved relative to the aneurysm neck to wound the aneurysm neck. Here, the movement is a back and forth movement and / or a rotational movement.

[0258] In some embodiments, at 208, an expandable device is delivered to the region of the aneurysm, e.g., the entrance to the aneurysm, where in some embodiments the device is delivered in a contracted and / or crimped configuration within a catheter. In some embodiments, if the expandable device is elastically expandable, the device is restrained from expanding by the walls of the catheter, e.g., as part of a catheterization procedure. In some embodiments, the delivery is assisted by imaging. In some embodiments, the expandable device is delivered into a blood vessel, e.g., via a catheter, and movement of the device is effected, e.g., by pressure applied to a push wire connected to the device.

[0259] In some embodiments, at 210, an expandable device is delivered to the aneurysm and expanded within the aneurysm, where in some embodiments the delivery and expansion occur simultaneously, e.g., a self-expanding device is delivered into the aneurysm sac while exiting the delivery catheter. In some embodiments, the self-expanding device expands towards a relaxed configuration within the aneurysm. In some embodiments, the device expands to a relaxed configuration. Alternatively, in some embodiments, the aneurysm sac prevents the device from fully expanding and / or the device at least partially conforms to the shape of the aneurysm sac (e.g., the configuration of expandable device 402 in FIG. 4H and / or the configuration of expandable device 1202 in FIG. 12E). Where, for example, in some embodiments, the shape of the expandable device at least partially conforms to the shape of the aneurysm when the elastic relaxation force of one or more portions of the expandable device is less than the resistance to expansion of a portion(s) of the aneurysm wall.

[0260] Alternatively, in some embodiments, the device is delivered and then expanded at a later time, for example, when the device is mechanically expanded (e.g., balloon expansion) after it is within the aneurysm and / or when the restraining element (e.g., a catheter) is withdrawn.

[0261] In some embodiments, at 212, the delivery apparatus (e.g., push wire) is detached from the expandable device, where in some embodiments the detachment is by one or more of mechanical detachment, electrolytic detachment, and electrothermal detachment.

[0262] For example, the separation can include one or more of the features shown in FIG. 23 and / or described with respect to separation region 2392 of FIG.

[0263] In some embodiments, at 214, the delivery device, including, for example, the push wire and / or the catheter, is withdrawn, for example, from the subject's body.

[0264] FIG. 3 is a flow chart of a treatment method according to some embodiments of the present invention.

[0265] At 300, in some embodiments, blood flow to and / or from the aneurysm is reduced, for example mechanically by a mesh, at least partially blocking the entrance to the aneurysm.

[0266] At 302, in some embodiments, thrombus formation within the aneurysm sac is stimulated by exposure of the aneurysm lumen to, for example, low level radiation, for example, a radiation level including one or more of the characteristics described in the section of this document entitled "Exemplary Radiation Levels."

[0267] At 304, in some embodiments, clots formed within the aneurysm (e.g., above a certain size) are prevented from migrating outside the aneurysm, for example, by blocking the passage of thrombus within the aneurysm and / or within the volume defined by the mesh structure into the lumen of the blood vessel into which the aneurysm is deforming with a mesh.

[0268] At 306, in some embodiments, closure of the entrance to the aneurysm is stimulated.

[0269] Optionally, in some embodiments, the stimulus includes wounding (e.g., mechanical and / or chemical wounding) of tissue at the entrance of the aneurysm (also referred to herein as the "aneurysm neck").

[0270] In some embodiments, the stimulation includes exposure to low level ionizing radiation, which in some embodiments stimulates closure of the aneurysm neck by endothelialization of the mesh on the aneurysm neck followed by neointima formation.

[0271] 4A-4H are simplified cross-sectional schematic diagrams illustrating the treatment of an exemplary aneurysm 426, according to some embodiments of the invention.

[0272] 4A , in some embodiments, the expandable device 402 is delivered to the mouth of the aneurysm 426 in a collapsed configuration by a delivery apparatus 420. In some embodiments, the delivery apparatus 420 includes a catheter 428, and the expandable device 402 is delivered through the catheter 428. In some embodiments, the expandable body 408 of the expandable device 402, when collapsed (e.g., into the catheter 428), collapses against a mount 406 that houses the radiation source 402.

[0273] 4B, in some embodiments, the expandable device 402 is delivered to the aneurysm 426. With reference to FIG. 4C, in some embodiments, the expandable device 402 is expanded within the aneurysm 426, where the delivery and / or expansion includes one or more of the features shown in FIG. 2 and / or described with respect to step 210 of FIG.

[0274] In some embodiments, once the expandable device 402 is expanded, it is then moved, for example using the push wire 422, for example to traumatize tissue, for example to position and / or reposition the expandable device within the aneurysm 426, as described in the steps of FIG.

[0275] Referring to FIG. 4D, in some embodiments, once the device is positioned within the aneurysm 426, the delivery apparatus 420 is then removed.

[0276] In some embodiments, the expandable device 402 is configured to hold the base of the device 402 in place (e.g., contacting tissue surrounding the aneurysm mouth) to close the aneurysm mouth of the aneurysm neck 430. In some embodiments, the length 409 of the expandable device in the proximal-distal direction is selected relative to the aneurysm length 411 to hold the device in place. In some embodiments, the expandable device 402 is selected such that, in at least the length dimension, in the expanded device's relaxed configuration, it is greater than the aneurysm length 411 such that the elastic expansion force of the device 402 on the walls of the aneurysm 426 holds the device in place. In some embodiments, this force is not sufficient to deform and / or weaken the walls of the aneurysm. Here, for example, in some embodiments, in one or more directions (e.g., at least along its length, e.g., in all directions), the dimension of the relaxed device in that direction is greater than the maximum and / or average dimension of the aneurysm (e.g., in that direction) by up to 5-50%, or 5-20%, or 5-10%, or a smaller, or greater, or intermediate percentage or range.

[0277] In some embodiments, the expandable device 402 includes an additional expandable support, which in some embodiments extends from the expandable body 408 to, for example, contact the aneurysm 426, for example, including one or more of the features shown in and / or described with respect to support 1682 of FIGS.

[0278] In some embodiments, the expandable device 402 is sized and / or shaped to expand to width 407 and / or hold the device 402 in place at the mouth of the aneurysm, where in some embodiments the expandable device does not contact the roof of the aneurysm and / or does not fill the length 411 of the aneurysm.

[0279] In some embodiments, the aneurysm neck width 405 is between 0.5 and 20 mm, or between 1 and 15 mm, or between 2 and 13 mm, or smaller, or larger, or intermediate widths or ranges.

[0280] In some embodiments, the average and / or maximum dimension of the aneurysm, e.g., height 411 and / or width 413, is 0.5-20 mm, or 2-15 mm, or 2-14 mm, or 2-13 mm, or smaller, larger, or intermediate dimensions or ranges. In some embodiments, the width 407 and / or length 409 of the expandable body 408 (e.g., in a relaxed configuration) is 1-20 mm, or 2-15 mm, or 3-14 mm, or smaller, larger, or intermediate dimensions or ranges.

[0281] Referring to FIG. 4E, in some embodiments, a thrombus 432 forms within the expandable device 402 and / or between the expandable device 402 and the wall of the aneurysm 426 (e.g., according to one or more features described and / or illustrated with respect to step 304 of FIG. 3).

[0282] 4F, in some embodiments, tissue growth at the aneurysm neck 430 (e.g., by one or more features described and / or illustrated with respect to step 306 of FIG. 3) acts to close the aneurysm 426. Here, in some embodiments, tissue first begins to grow over the mesh of the expandable device 402, as shown, for example, by dashed line 431. Then, in some embodiments, tissue continues to grow to close the entrance to the neck, for example, as illustrated in FIG. 4G. In some embodiments, closure of the neck is achieved while the expandable device 402 remains expanded within the aneurysm.

[0283] 4G, the sac of the aneurysm 426 begins to shrink and collapses onto the expandable device 402. In some embodiments, the aneurysm 426 continues to shrink. In some embodiments, the shrinkage of the aneurysm causes the expandable device 402 to partially collapse, for example, as shown in FIG. 4H.

[0284] Example expansion device 5-10 are simplified schematic cross-sectional views of exemplary expandable devices.

[0285] In some embodiments, each device 502, 602, 702, 802, 902, and 1002 has a proximal end 114 and a distal end 118, and includes a tubular wall 110 and, in some embodiments, a radiation source 104 that is attached to the body of the expandable device via a mount 106.

[0286] All of Figures 5-10 show exemplary embodiments in which the radiation source 104 is located in a central region of the expandable device in a direction perpendicular to the proximal-distal direction, at least in the cross-sections shown in Figures 5-10. In some embodiments, the radiation source is located in a central region of the device in all directions perpendicular to the proximal-distal direction.

[0287] 5, 6, and 8-10 show an exemplary embodiment in which the radiation source 104 is positioned proximally-distally within a central region of the expandable device.

[0288] 5-9 show exemplary embodiments in which the source 104 and / or holder 106 are attached to the base of the device, i.e., base 516, 616, 716, 816.

[0289] 5, 6 and 8 show exemplary embodiments in which the source 104 and / or holder 106 are mounted to concave device bases 516, 616 and 816, respectively.

[0290] 6-8 and 10 show exemplary embodiments in which the device includes a closed top portion 640, 740, 840, 1040.

[0291] 5 and 9 show an exemplary embodiment including a top portion having an opening 540, 940. FIG.

[0292] 6, 8 and 10 show exemplary embodiments in which the tops 640, 840 and 1040 are attached to the source 104 and / or the holder 106. In the embodiment shown in FIG.

[0293] In some embodiments, the expandable device is subjected (e.g., at a treatment site, e.g., within an aneurysm) to a force 151, 151, such as a compressive force 151 in a proximal-distal direction, and / or a force 153 in a direction perpendicular to the proximal-distal direction (e.g., axial).

[0294] In some embodiments, the shape of the recess (eg, base and / or top) provides structural resilience against contraction and / or collapse in the proximal-distal direction, such as the embodiment shown in FIG.

[0295] In some embodiments, closure of the top (or base), even if partial, increases structural elasticity in the proximal-distal direction, as shown, for example, for top 540 in FIG. 5 and / or top 940, base 916 in FIG. 9, all of which are partially closed, as shown in FIGS. 5-10.

[0296] FIG. 5 shows an exemplary embodiment in which the base 516 is partially recessed into the wall 510 and the device 502 lacks an upper portion (or the upper portion partially covers the lumen defined by the wall 110).

[0297] FIG. 6 illustrates an exemplary embodiment in which both the base 616 and the top 640 are partially recessed into the wall 610 .

[0298] 7 shows an example embodiment that includes both a closed base 716 and a closed top 740, where neither the base 716 nor the top 740 are recessed. In some embodiments, the source 104 and / or holder 106 are located at the proximal end of the expandable device 702.

[0299] FIG. 8 illustrates an exemplary embodiment in which both the base 816 and the top 840 are closed and / or concave.

[0300] FIG. 9 illustrates an exemplary embodiment in which both the base 916 and the top 940 are open, and a support structure 970 connects the source 104 and / or holder 106 to the wall 110.

[0301] 10 illustrates an exemplary embodiment in which the source 104 and / or holder 106 are attached to a top 1040 (rather than a base 1016). In some embodiments, both the base 1016 and the top 1040 are closed. In some embodiments, the top 1040 is recessed but the base 1016 is not recessed. Alternatively, both the top 1040 and the base 1016 are recessed, e.g., without the base 1016 being attached to the source 104 and / or support 106.

[0302] FIG. 11 is a simplified diagram of an extendable device 1102 according to some embodiments of the invention.

[0303] In some embodiments, the expandable device 1102 includes an expandable body 1108 having a wall 1110 and a base 1116. In some embodiments, one or more portions of the body 1108 are formed from a mesh, such as a flow diverter braided mesh (e.g., including one or more of the features described in the "Exemplary Expandable Body Materials" section of this document). Optionally, in some embodiments, the body 1108 includes an upper portion 1140.

[0304] In some embodiments, arrow 1109 indicates the proximal-distal direction of device 1102 , and in some embodiments, base 1116 is proximal to top 1140 .

[0305] In some embodiments, the length 1109, width 1107, and / or depth 1160 (in some embodiments, the cross section 1121 is symmetrical) are 1-20 mm, or 2-15 mm, or 3-14 mm, or smaller, or larger, or intermediate dimensions or ranges. In some embodiments, the wall 1110 forms a tubular structure, where in some embodiments, the lumen enclosed by the wall maintains a constant cross section along the length 1109 of the wall 1110. In some embodiments, the base 1116 closes the proximal end of the wall 1110. In some embodiments, the length 1109 is 1-20 mm, or 2-10 mm, or 2-15 mm, or 3-14 mm, or smaller, or larger, or intermediate dimensions or ranges.

[0306] In some embodiments, the ratio of length 1109 to width 1107 and / or depth 1160 is between 1:1 and 1:10, or between 1:1 and 1:5, or smaller, or larger, or intermediate ratios or ranges.

[0307] In some embodiments, the expandable device 1102 includes a source holder 1138 connected to the expandable body 1108, for example at the base 1116. For example, in a central region of the base, for example, in some embodiments, the holder 1136 and / or the center 1117 of the holder cross section 1119 are located within a central region of the cross section 1121 of the expandable body 1108, where the cross section is taken parallel to the base 1116 and / or perpendicular to the wall 1110. For example, when the holder cross section 1119 and / or the center 1117 are in a central region of the expandable body cross section 1121, for example, the center 1117 is located within a central region of the width 1107 and / or depth 1160 of the expandable body cross section 1121. Here, in some embodiments, the central region is defined as the central 5-80%, or 5-50%, or 5-20%, or a lower, smaller, or greater, or intermediate percentage or range of the length and / or cross-sectional area.

[0308] In some embodiments, the holder includes a lumen 1146 sized and / or shaped to receive the radiation source. In some embodiments, the average and / or maximum cross-sectional dimension 1109 of the holder cross-section is 0.05-1 mm, or 0.05-0.5 mm, or 0.1-0.4 mm, or smaller, larger, or intermediate ranges or dimensions. In some embodiments, the holder 1106 extends within a majority of the length 1109 of the device, such as within 50-95% of the length of the device, or 50-80%, or smaller, larger, or intermediate percentages or ranges. Alternatively, in some embodiments, the holder is short relative to the length 1109, having a length of at most 50%, or 5-30%, or smaller, larger, or intermediate ranges or percentages of the length 1109 of the device. In some embodiments, a long holder holds a short source (e.g., less than 50% of the length of the holder lumen), potentially allowing for selective positioning of the source within the holder and / or allowing more than one source to be loaded into the holder, for example, as shown in FIG. 27 where holder 2706 holds two sources 2704a, 2704b.

[0309] In some embodiments, the lumen 1146 is defined by a plurality of arms 1136. In some embodiments, the arms 1136 are connected at a proximal end by a holder base 1136. In some embodiments, the holder base 1136 is connected to the base 1116 of the expandable body 1108.

[0310] In some embodiments, portion(s) 1134, 1136 form a cap for holder 1138. In some embodiments, portion 1134 is an attachment for a push wire (not shown) to expandable body 1108. In some embodiments, attachment 1134 is a screw attachment that includes threads on connector 1134 and / or portion 1136. In some embodiments, to remove the push wire, portion 1136 is unscrewed from portion 1134. Other attachment mechanisms between portions 1134, 1136 (e.g., attachment mechanisms described elsewhere in this document) are envisioned and encompassed.

[0311] In some embodiments, the holder 1138 is connected to the expandable body 1108 by a connector, which in some embodiments has a ring shape and / or is optionally radiopaque, where in some embodiments the connection is by one or more of crimping, welding, and quenching.

[0312] Optionally, in some embodiments, the arms 1136 are connected at one or more additional locations (not shown) distal to the holder base 1136, with the additional connection(s) potentially strengthening the holder.

[0313] In an exemplary embodiment, the distal end 1135 of the arm 1136 is shaped to prevent the source from exiting distally from the lumen 1146. For example, in some embodiments, the distal end 1135 of the arm 1136 is curved to reduce a cross-section of the lumen 1146, e.g., at the distal end of the lumen 1146. Alternatively, or additionally, in some embodiments, the holder includes a base attached to the arm 1136, e.g., at the distal end 1135 of the arm.

[0314] Optionally, in some embodiments, the holder 1138 includes a cap 1134 sized and / or shaped to prevent the radiation source in the lumen 1146 from falling out. In some embodiments, the cap 1134 closes an end of the lumen 1146. Alternatively, in some embodiments, the cap 1134 narrows the opening of the lumen 1146 to a size less than would allow the passage of the radiation source. In some embodiments, the cap 1134 is connected to the holder by a threaded mechanism, where, for example, the cap 1134 and / or the holder base 1136 include threads. In some embodiments, the cap 1134 and / or the holder 1138 include one or more features of the cap 2499 and / or the holder 2406 described with respect to and / or illustrated in FIG. 24 .

[0315] Optionally, in some embodiments, once the radiation source is positioned within lumen 1146, the radiation source is locked in place, e.g., by deforming one or more of arms 1136, e.g., towards the radiation source. In embodiments in which the arms deform, cap 1134 is optional.

[0316] 12A-12F are simplified schematic diagrams of an expandable device 1202, according to some embodiments of the invention.

[0317] FIG. 12A is a simplified schematic diagram of an expandable device 1202 from a distal direction, according to some embodiments of the invention.

[0318] FIG. 12B is a simplified schematic side view of an expandable device 1202 according to some embodiments of the invention.

[0319] In some embodiments, FIGS. 12A-12D show the expandable device 1202 in a relaxed configuration, for example, where no external force is applied to the expandable device 1202.

[0320] In some embodiments, the expandable device 1202 has an expandable body 1208 including walls 1210 and a base 1216. In some embodiments, the walls 1210 and base 1216 form a flattened cup shape, for example, when the device 1202 is in a relaxed, expanded configuration. In some embodiments, the width 1207 and / or height 1260 of the shape formed by the walls 1210 and base 1216 is at least 1.5 times, or at least 2 times, or 1.5-10 times, or 3-10 times, or 3-7 times, or about 5 times the thickness 1209 of the shape.

[0321] In an exemplary embodiment, a kit of expandable bodies (e.g., one of the bodies is selected for treatment of a particular aneurysm, e.g., based on the size of the aneurysm) includes devices having widths (and / or heights 1260, e.g., in embodiments where the devices are rotationally symmetric about a central distal-proximal axis 1299) of 5 mm, 7 mm, 9 mm, 11 mm, and 14 mm, where in some embodiments the thickness in the kit is 3-7 times the height and / or width.

[0322] In some embodiments, the device is symmetrical about one or more axes (e.g., when in a relaxed configuration). For example, in some embodiments, the width 1260 and height 1207 of the expandable body 1208 are the same, e.g., within 10%, or 5%, or 2%, or smaller, or larger, or intermediate percentages of each other. In exemplary embodiments, the maximum and / or average width 1260 and / or height 1207 are 1-20 mm, or 2-20 mm, or 4-15 mm, or smaller, or larger, or intermediate dimensions or ranges. In some embodiments, the expandable device includes one or more supports 1240. In some embodiments, the supports 1240 reinforce the wall 1210 and / or support the radiation source (radiation source not shown in FIGS. 12A-12B).

[0323] In some embodiments, supports 1240 are large compared to wall 1210, having a maximum and / or average cross-sectional dimension (and / or height 1215 and / or width 1262) that is 40-110%, or 50-100%, or 60-90%, or a smaller, larger, or intermediate percentage or range of the comparable dimension of wall 1210. Here, the large supports may strengthen device 1202, thus potentially preventing collapse of the device and / or providing a stronger obstruction to fluid flow to and / or from the aneurysm.

[0324] Alternatively, in some embodiments, the support 1240 is smaller, with a maximum and / or average cross-sectional dimension (and / or height 1215 and / or width 1262) that is 1-20%, or 1-10%, or a smaller, greater, or intermediate percentage or range of the comparable dimension of the wall 1210. A smaller support may make it easier to crimp and / or deploy the device 1202.

[0325] In some embodiments, the radiation source is surrounded by the expandable structure 1208, e.g., the source is surrounded proximally by the base 1216 and the wall 1210, and distally by the support structure 1240 (in some embodiments, except for an opening 1248 in the support structure 1240). In some embodiments, with respect to the description elsewhere in this body, the support structure 1240 and / or the distal surface of the support structure 1240 are considered to be the top relative to the device.

[0326] In some embodiments, opening 1248 provides access to the interior volume of expandable device 1202, for example, to secure a radiation source within expandable body 1208. In some embodiments, opening 1248 has a small area, e.g., no more than 1-10%, or 1-5%, or a smaller, or larger, or intermediate percentage or range, of the maximum extent cross-section of wall 1210 (e.g., as shown by dimensions 1260, 1207).

[0327] FIG. 12C is a simplified schematic cross-sectional view of an expandable device 1202 according to some embodiments of the invention.

[0328] In some embodiments, FIG. 12C shows a cross-sectional view taken at the central axis of the expandable device 1202, for example along line AA marked in FIG. 12A.

[0329] FIG. 12C shows a radiation source 1204 attached to an expandable body 1208 by a holder 1206 in some embodiments.

[0330] In some embodiments, the source 1204 is mounted in a holder 1206 as described and / or illustrated with respect to one or more of Figures 19A-19C, 20A-20C, 21, 22A-22B, and 23-26.

[0331] In an exemplary embodiment, the source 1204 is attached to the holder 1206 by elastically deforming the source 1204 when attaching the source to the holder, such that the elastic relaxation of the source holds the source on the holder. In this case, for example, in some embodiments, the source is wrapped around the holder 1206 one or more times, e.g., in a coil, where in some embodiments the wraparound and / or wraparound of the source is optionally elastically deformed within the attachment, e.g., the relaxed lumen of the source is smaller than the outer dimensions of the holder 1206 to which the source is attached.

[0332] In some embodiments, the holder 1206 is attached to the expandable body by a connector 1266. In some embodiments, the connector 1266 has a ring shape. Optionally, in some embodiments, the connector 1266 includes a radiopaque material. In some embodiments, the holder 1206 and the source are not shown in FIGS. 12A-12B. In some embodiments, the holder 1206 extends away from the expandable body (e.g., distally). A potential advantage is that the source 1204 can be positioned in the central region of the aneurysm, as shown, for example, in FIG. 12F. A potential disadvantage of an extending holder 1206 is an increased risk of rupture of the aneurysm 1226 by the holder, for example, during delivery and / or deployment of the device 1202.

[0333] In some embodiments, the support structure 1240 includes two or more layers, where in an exemplary embodiment, the support structure 1240 is a loop extending from a central region of the device 1202. In some embodiments, the support structure 1240 is connected to the radiation source 1204, for example, at a central region (e.g., the central 20%) of the support structure.

[0334] In some embodiments, the support structure 1240 provides an additional layer (e.g., of mesh) that provides occlusion of the aneurysm mouth. In some embodiments, the support structure 1240 may provide additional mechanical resistance to collapse of the device.

[0335] FIG. 12D is a simplified schematic top view of an expandable device 1202 from a proximal direction, according to some embodiments of the invention.

[0336] FIG. 12E is a simplified schematic cross-sectional view of expandable device 1202 in a collapsed state according to some embodiments of the invention.

[0337] In some embodiments, the expandable device 1202 is delivered to the treatment site in a collapsed configuration, for example, as shown in and / or described with respect to Figure 2. In some embodiments, the device is collapsed by insertion into a catheter 1256. In some embodiments, the device is delivered through the catheter 1256.

[0338] In some embodiments, in the collapsed configuration within the catheter 1256, the expandable body is extended such that the portion(s) do not overlap and the expandable body forms a single-layered tubular structure within the catheter.

[0339] FIG. 12F is a simplified schematic cross-sectional view of expandable device 1202 within an aneurysm 1226, according to some embodiments of the present invention.

[0340] In some embodiments, the wall 1210 and / or the support structure 1240 at least partially conform to the shape of the aneurysm 1226. For example, the wall 1210 and / or the support structure 1240 bend away from a relaxed configuration toward a central region of the device and / or toward the source 1204. In some embodiments, the expandable device 1202 bends into a hemispherical shape.

[0341] A potential advantage of an expandable device 1202 that at least partially conforms to the aneurysm is the ability to deliver the device to the aneurysm from a variety of different angles to seal the mouth of the aneurysm with the walls of the device.

[0342] In some embodiments, the expandable device 1202 provides a gradual curvature (e.g., a curvature provided by the base 1216 and / or the wall 1210) at least at a proximal portion of the device when the device is deployed within the aneurysm. In some embodiments, the gradual curvature is additionally or alternatively provided by bending the wall 1210 as it conforms to the shape of the aneurysm. A potential benefit of the gradual curvature is that for a variety of different rotational orientations of the expandable device 1202 within the aneurysm 1226, the surface of the device does not impede fluid flow in a blood vessel distorted by the aneurysm (e.g., associated with reduced risk of clotting).

[0343] In some embodiments (not shown), the wall 1210 and optionally the base 1216 are formed of a double layer mesh, potentially promoting a reduction in flow between the internal volume of the aneurysm 1226 and the blood vessel into which the aneurysm 1226 is deformed, and / or increasing scaffolding, potentially increasing the rate of tissue growth to close the mouth of the aneurysm.

[0344] FIG. 12G is a simplified schematic cross-sectional view of expandable device 1202 according to some embodiments of the invention.

[0345] In some embodiments, FIG. 12G shows a cross-sectional view taken at the central axis of the expandable device 1202, for example along line AA marked in FIG. 12A.

[0346] FIG. 12H is a simplified schematic cross-sectional view of expandable device 1202 within an aneurysm 1226, according to some embodiments of the present invention.

[0347] In some embodiments, the device shown in and / or described in Figures 12A-12F includes an alternative connection of the source 1204 to the expandable body 1208 (e.g., different from that shown in Figures 12C and 12F).

[0348] In some embodiments, the source 1204 is positioned proximal to the connector 1266 (e.g., at a proximal position of the source including one or more features shown in FIG. 26 and / or described with respect to the source 2604 and / or the holder 2606 and / or the connector 2666 of FIG. 26).

[0349] In an exemplary embodiment, the source 1204 is attached to the holder 1206 by elastically deforming the source 1204 when attaching the source to the holder, such that an elastic relaxation force of the source holds the source on the holder. In some embodiments, the source is wrapped around the holder 1206 one or more times, e.g., coiled, where in some embodiments the source wrap and / or the source wrap is optionally elastically deformed within the attachment, e.g., the relaxed lumen of the source is smaller than the outer dimensions of the holder 1206 to which the source is attached.

[0350] In some embodiments, the connector 1266 holds the mesh portions together without a holder therebetween, e.g., without a support 1206 therebetween (e.g., in some embodiments the connector 1266 is directly connected, e.g., by welding the mesh and / or quenching the connector to the mesh). In some embodiments, the source 1204 is a coil and / or ring that is directly attached, e.g., crimped, onto the mesh of the expandable body 1208, e.g., without a support 1206 therebetween.

[0351] The holder is optional if neither the connector 1266 nor the source 1204 holds the mesh on the holder 1206. In some embodiments, the source 1204 itself connects the mesh, and both the holder 1206 and the connector 1266 are optional.

[0352] 13A-13B are simplified schematic cross-sectional views of an expandable device 1302, according to some embodiments of the invention.

[0353] FIG. 13C is a simplified schematic cross-sectional view of a portion of expandable device 1302, according to some embodiments of the invention.

[0354] In some embodiments, FIGS. 13A-13B and 13C show the same expandable device 1302.

[0355] In some embodiments, the expandable device 1302 includes an expandable body 1308 having a wall 1310 and a base 1316. In some embodiments, the shape of the wall 1310 includes one or more of the features shown and / or described with respect to the wall 1110 of FIG.

[0356] In some embodiments, the base 1316 includes a recessed central portion 1360, the potential benefit of which is to recess the connection(s) (e.g., of the base 1368 and / or the holder 1306 and / or the push wire 1322) from the flow in the lumen where the aneurysm is deforming. In some embodiments, the recess 1360 is a small area portion of the base 1316, potentially preventing the formation of large thrombi within the recessed portion. Here, in some embodiments, for a cross section taken perpendicular to the elongation direction of the wall 1310 and / or in a proximal-distal cross section, the recess 1360 is at most 1-30%, or 1-20%, or a smaller, larger, or intermediate percentage or range of the area of ​​the wall cross section. Here, in some embodiments, the recess 1360 is at most 0.1-5 mm in area for a cross section taken perpendicular to the elongation direction of the wall 1310 and / or in a proximal-distal cross section. 2 , 0.1~3mm 2 In some embodiments, the recess is to a depth of 0.5-20 mm, or 0.5-10 mm, or 0.5-5 mm, or 1-5 mm, or lesser, greater, or intermediate ranges or distances.

[0357] In some embodiments, the distal end 1318 of the expandable body includes an upper portion 1380 that partially closes the lumen defined by the wall 1310, for example, leaving a distal opening of the expandable device 1308 where the maximum cross-sectional dimension 1323 of the opening is 70-99%, or 80-99%, or a smaller, or larger, or intermediate range or percentage, of the maximum cross-sectional dimension 1307 of the wall 1310.

[0358] In some embodiments, the device 1302 includes a support 1362 that, in some embodiments, extends from the top 1380 and / or wall 1310 at the distal end 1318 of the expandable body 1308. In some embodiments, the support 1362 is recessed into the wall 1110. In some embodiments, the support 1362 extends toward a central region of the volume defined by the wall 1310 as it transitions proximally from the distal end 1318. In some embodiments, the support 1362 forms a frustoconical portion with the tip of the frustoconical portion facing in the proximal direction. A potential advantage of the support 1362 is that it increases the resistance of the device to collapse and / or compression in the proximal-distal direction. In some embodiments, the lack of a connection at the proximal end of the support 1362 potentially means that there is no connection structure with associated benefits, for example, as described in the next paragraph. This, in some embodiments, comes at the expense of risk of unraveling and / or delamination of the wiring at the proximal end.

[0359] A potential advantage of not connecting the distal ends of the walls 1310 (e.g., to form a top) and / or recessing the distal wall connection into the wall 1310 (e.g., as shown by connection 1770 in FIG. 17B ) is that the risk of the connection protruding and damaging and / or rupturing the aneurysm, for example, when the expandable device is delivered and / or expanded, is reduced. In some embodiments, the expandable body 1308 includes a wall support structure 1362, which in some embodiments is a recess extending from the top 1380.

[0360] Potential advantages of the recess(es), such as portion 1360 and / or portion 1362, include one or more of the advantages described in the "Overview" section of this document, such as locating the source in a central region of the device, reducing disruption of vascular blood flow at the connection to the body, providing enhanced scaffolding for tissue healing, and increasing the mechanical resistance of the device to collapse.

[0361] In some embodiments, the expandable device 1302 includes a holder 1306 for a radiation source (the radiation source is not shown in Figures 13A-13B).

[0362] In some embodiments, the holder 1306 is attached to the base 1316, e.g., in a recessed central portion 1366 of the base 1316. In some embodiments, the holder 1306 is held in a central region of the expandable device 1308. For example, in a central region of the base, e.g., in some embodiments, the holder 1336 and / or the center 1317 of the holder cross section is located within a central region of the cross section 1121 of the expandable body 1308, where the cross section is taken parallel to the base 1316 and / or perpendicular to the wall 1310. For example, if the holder cross section and / or center 1317 is in a central region of the expandable body cross section 1321, e.g., the center 1317 is located within a central region of the width 1307 and / or depth 1360 of the expandable body cross section 1321. Here, in some embodiments, the central region is defined as the central 5-80%, or 5-50%, or 5-20%, or a lower, smaller, or greater, or intermediate percentage or range of the length and / or cross-sectional area.

[0363] In some embodiments, the holder 1306 comprises a material that is resistant (e.g., maintains its mechanical properties) to ionizing radiation. In some embodiments, the holder 1306 comprises an electrically insulating material (e.g., if electrochemical detachment is used to detach the push wire). In an exemplary embodiment, the holder 1306 comprises a polymer (e.g., an ionizing radiation resistant polymer, such as PEEK and / or polyimide and / or cyanoacrylate), and in some embodiments is formed of a polymer. In some embodiments, the radiation source is attached to the holder 1306, e.g., at a distal portion of the holder. In some embodiments, the holder 1306 connects the push wire 1322 to the expandable body 1308. For example, in an exemplary embodiment, the holder 1306 includes a lumen 1364 into which the distal end of the push wire 1322 is inserted. In some embodiments, the connection between the push wire 1322 and the holder 1306 is by adhesion; for example, by heat adhesion, where the joint is heated to cause the material of the holder 1306 to adhere onto the push wire 1322. For example, by adhesion, such as by applying an adhesive to the push wire and / or support 1306 and then bringing them into contact (e.g., inserting the push wire into lumen 1364). In some embodiments, adhesion uses a cyanoacrylate adhesive. In some embodiments, at least a portion of holder 1306 is formed from cyanoacrylate, which serves both adhesion, mechanical support (including resistance to ionizing radiation), and optionally galvanic and / or electrical thermal insulation, for example as described with reference to the exemplary holders herein.

[0364] Reference is now made to Figure 13C (although the feature(s) described in this paragraph are also shown in Figures 13A-13B). In some embodiments, the holder 1306 is attached to the base 1316 by a connector 1366, which in some embodiments holds a portion 1368 of the base 1316 on the holder 1306, for example. In some embodiments, the connector 1366 is ring-shaped. Optionally, in some embodiments, the connector 1366 comprises a radiopaque material.

[0365] Optionally, in some embodiments, recess 1362 is attached to one or both of base 1366 and / or holder 1306 (not shown in FIGS. 13A-13B). In some embodiments, portion 1362 is held on holder 1306 together with base 1366 by connector 1366. Alternatively or additionally, in some embodiments, a second connector (e.g., a second ring) connects portion 1362 to holder 1306.

[0366] FIG. 14A is a simplified schematic cross-sectional view of an expandable device 1402 according to some embodiments of the invention.

[0367] 14B-14C are simplified schematic diagrams of an expandable device 1402 according to some embodiments of the invention.

[0368] In some embodiments, FIGS. 14A and 14B-C show the same expandable device 1402.

[0369] In some embodiments, the expandable device 1402 includes an expandable body 1408 having a base 1416 (at the proximal end of the expandable body 1408), a wall 1410, and a top 1440 (at the distal end of the expandable body 1408).

[0370] In some embodiments, the wall 1410 is tubular and has a cross-section that widens distally. In some embodiments, the width 1415 at the proximal end of the wall 1410 (which in some embodiments corresponds to the width of the base 1416) is greater than the width 1407 at the distal end of the wall (which in some embodiments corresponds to the width of the top 1440), where the widths are for the same cross-section of the device shown in FIG. 14A, for example. In some embodiments, the wall 1410 gradually widens from the base 1416, where the distal width 1407 is 1.05 to 2 times, or 1.1 to 1.5 times, or about 1.3 times, or smaller, or larger, or intermediate multiples or ranges, of the proximal width 1415.

[0371] In some embodiments, the depth 1409 of the expandable body 1408 ranges from 0.2 to 2 times, or 0.5 to 1 times, or about 0.7 times, or a smaller, larger, or intermediate multiple or multiple of the base width 1407. In some embodiments, the depth 1409 of the expandable body 1408 ranges from 0.1 to 5 times, or 0.2 to 1 times, or about 0.6 times, or a smaller, larger, or intermediate multiple or multiple of the base width 1407.

[0372] In some embodiments, the expandable body 1408 is symmetrical in a direction(s) perpendicular to the proximal-distal direction. For example, the lumen defined by the wall 1410 is circular along the length 1409 of the wall. In some embodiments, the expandable body 1408 has a frusto-conical shape (with the tip of the frusto-conical shape being truncated).

[0373] In some embodiments, the holder 1406 (including one or more features shown in FIGS. 13A-13B and / or described with respect to the holder 1306 of FIGS. 13A-13B) wherein the positioning of the center of the holder 1406 (e.g., as described with respect to the holder 1306 of FIGS. 13A-13B) is, in some embodiments, with respect to a cross-section of the base 1416 and / or the top 1440 and / or the wall 1410.

[0374] In some embodiments, the holder 1406 is elongated. In some embodiments, the top 1440 includes a top opening 1476. In some embodiments, a source (not shown) is attached to the holder 1406 by accessing the holder 1406 through the opening 1476. In some embodiments, the push wire 1422 is connected to the holder 1406 at a proximal end of the holder 1406.

[0375] In some embodiments, the base 1416 and / or the base recess 1460, and / or the connection of the base 1416 to the holder 1406, e.g., by connector 1366, includes one or more features shown in Figures 13A-13B and / or described with respect to the base 1316 and / or the base recess 1360 and / or the base 1316 and / or the connection of the base 1316 to the holder 1306, e.g., by connector 1366, respectively, of Figures 13A-13B.

[0376] Optionally, in some embodiments, top portion 1440 is attached to holder 1306 (not shown in FIGS. 13A-13B). In some embodiments, top portion 1440 is held on holder 1406 together with base 1466 by connector 1466. Alternatively or additionally, in some embodiments, a second connector (e.g., a second ring) connects top portion 1440 to holder 1406.

[0377] 14C, in some embodiments, the holder 1406 protrudes from a recessed base 1460.

[0378] In some embodiments, the setback of connector 1468 (or any of elements 1204, 1368, 1568, 1766) is, in some embodiments, to a depth 1469 of 0.1-5 mm, or 0.1-2 mm, or 0.1-1 mm, or a smaller, or larger, or intermediate depth or range. Here, the term connector is used, at least in this paragraph and the paragraphs following this paragraph, in some embodiments, to refer to an element(s) of a device that connects materials (e.g., mesh material of the device) to one another and / or an element(s) that is stiff, for example, compared to the material (e.g., mesh) of the body of the device.

[0379] In some embodiments, the material of the device is recessed further than the depth of connector 1468 and curves to meet connector 1468, the maximum depth of the recessed material being, for example, from the surface of the base of the device, in some embodiments, 0.1-10 mm, or 0.5-5 mm, or 1-5 mm, or smaller, or larger, or intermediate distances or ranges.

[0380] FIG. 15A is a simplified schematic cross-sectional view of an expandable device 1502 according to some embodiments of the invention.

[0381] 15B-15C are simplified schematic diagrams of an expandable device 1502 according to some embodiments of the invention.

[0382] In some embodiments, FIGS. 15A and 15B-C show the same expandable device 1502.

[0383] In the exemplary embodiment, the expandable device 1502 includes a wall 1510, a base 1516, a partially open distal end 1518, and a centrally located holder 1506.

[0384] Here, in some embodiments, the wall 1510 of the expandable body 1508 has a shape that includes one or more of the features shown and / or described with respect to the wall 1410 in Figures 14A-14C. For example, in some embodiments, the expandable body 1508 has a frusto-conical shape.

[0385] Here, in some embodiments, base 1516 includes one or more of the features shown in and / or described with respect to base 1316 of expandable device 1302 of, for example, recess 1560 and / or connection portion 1566 correspond to recess 1360 and / or portion 1366.

[0386] Here, in some embodiments, the partially open distal end 1518 of the expandable device 1502 includes one or more features shown in Figures 13A-13B and / or described with respect to the partially open distal end 1318 of the expandable device 1302 of Figures 13A-13B.

[0387] Here, in some embodiments, the holder 1506 includes one or more features shown in Figures 13A-13C and / or described with respect to the holder 1306 in Figures 13A-13C and / or described with respect to the position of the holder 1406 in Figure 14A (e.g., relative to the portion(s) of the expandable body 1408).

[0388] In some embodiments, the expandable device 1502 includes a support 1562 extending proximally from (and optionally attached to) the top portion 1540, which extends toward the base 1516 and closely conforms to (and / or contacts) the wall 1510. In some embodiments, the support 1562 extends to and closely conforms to (and / or contacts) a portion of the base 1516 to provide a bilayer base region 1578. In some embodiments, the support 1562 closely follows (e.g., is separated from the wall 1510 and / or base 1516 by a distance of up to 0.5 mm, or 0.3 mm, or 0.2 mm, or 0.01-0.5 mm, or 0.01-0.2 mm, or 0.05-0.2 mm, or 0.1-0.2 mm, or less, greater, or intermediate distances) and / or contacts the surface of the wall 1510 and / or base 1578.

[0389] In some embodiments, the support 1562 is recessed within the wall 1510 (e.g., as shown in FIG. 15A ) and supports the wall 1510 and / or the base 1516 within the wall 1510. Alternatively, in some embodiments, the support 1562 is disposed outside the wall 1510 and / or proximal to the base 1516.

[0390] Optionally, in some embodiments, the support 1562 extends to the holder 1506 (eg, closely following the base 1516 including the base recess 1560).

[0391] In some embodiments, ends 1578 of supports 1562 are at the exterior region of base 1516. A potential advantage is that the dual layer provided by supports 1562 reduces blockage of radiation emissions from a source connected to holder 1516. In some embodiments, supports 1562 terminating before a central region of base 1516 may relate to properties of an expanding mesh structure, for example, since mechanical support and / or reduced porosity is provided by a denser wire distribution in base 1516 at the central region of the device.

[0392] Optionally, in some embodiments, the support 1562 extends, for example centrally along the recess 1560 in the base and is connected to the holder 1506 .

[0393] FIG. 16A is a simplified schematic cross-sectional view of an expandable device 1602 according to some embodiments of the invention.

[0394] FIG. 16B is a simplified schematic diagram of an expandable device 1602 according to some embodiments of the invention.

[0395] In some embodiments, FIGS. 16A and 16B show the same expandable device 1602.

[0396] In the exemplary embodiment, the expandable device 1602 includes a wall 1610, a base 1616, a centrally located holder 1606, a partially closed top 1640, and a support 1662.

[0397] Here, in some embodiments, wall 1610 has a shape that includes one or more of the features shown and / or described with respect to wall 1310 in FIGS. 13A-13B.

[0398] Here, in some embodiments, base 1616 includes one or more of the features shown in and / or described with respect to base 1316 of FIGS. 13A-13B.

[0399] In some embodiments, the support 1662 extends from the top 1640 and / or follows the wall 1610 as shown in FIG. 15A and / or described with respect to the support 1562 and the wall 1510 of FIG. 15A.

[0400] In some embodiments, the source 1604 is attached to a holder 1606, where one or more features of the attachment and / or source are as exemplarily mentioned and / or described in the section entitled "" of this document. In an exemplary embodiment, the source 1604 is a rhodium strip irradiated with Pd-103. In some embodiments, the source 1604 is attached to the holder 1606 by wrapping the strip onto the holder. Alternatively or additionally, the source 1604 is provided as a coil and attached onto the holder 1606, for example, by an interference fit associated with the sizing of the holder 1606 and / or the source 1604.

[0401] In some embodiments, the support wall 1662 does not extend to the base 1616. In some embodiments, the support 1662 does not extend to a proximal portion of the wall 1610. A potential advantage is reduced blockage by the support 1662 of radiation emissions from the source 1604 in a direction toward the mouth of the aneurysm.

[0402] Optionally, in some embodiments, the expandable device 1602 includes one or more distal supports 1682. In some embodiments, the distal supports 1682 are configured to hold the expandable device 1602 in place within the aneurysm, e.g., to hold the device 1602 in place to close the aneurysm mouth to the aneurysm. In some embodiments, the distal supports 1682 are expandable structures that expand distally, e.g., to contact and / or apply pressure to the top of the aneurysm. In some embodiments, a counter force induced against the pressure from the aneurysm on the device pushes the device into contact with the aneurysm mouth. In an exemplary embodiment, the distal supports 1682 are springs. In some embodiments, the distal supports 1682 are connected to the holder 1606. Alternatively or additionally, in some embodiments, the distal supports are attached to one or more of the base 1616, the wall 1610, and the top 1640.

[0403] In some embodiments, in a collapsed configuration (eg, of the distal support 1682 and / or the expandable device 1602), the distal support 1682 is recessed into the wall 1610.

[0404] In some embodiments, the expandable devices shown in Figures 1, 4A-4H, 5-10, 11, 12A-12F, 13A-13C, 14A-14C, 15A-15C, 17A-17B, and 18 include a distal support including feature(s) shown in Figures 16A-16B and / or described with respect to distal support 1682 of Figures 16A-16B, for example.

[0405] FIG. 17A is a simplified schematic diagram of an expandable device 1702 according to some embodiments of the invention.

[0406] FIG. 17B is a simplified schematic cross-sectional view of an expandable device 1702 according to some embodiments of the invention.

[0407] In some embodiments, FIGS. 17A and 17B show the same expandable device 1702.

[0408] The device 1702, in some embodiments, is described in comparison to descriptions elsewhere herein as having a wall 1710, a base 1716 to which the holder 1706 is attached, and a proximally located support structure including a support wall 1786 and a support base 1784. Here, the support structure 1738 has a push wire 1722 attached thereto.

[0409] Alternatively, in some embodiments, the device 1702 is described, as compared to the description in other part(s) of this document, as having a base 1784 and a recess 1788 in the base 1784 to which the push wire 1722 is attached, where the base 1784 is connected to a wall 1786 closed by a top 1710 to which the holder 1706 is connected.

[0410] Here, for example, recessed base 1788 includes one or more of the features shown in Figures 14A-14B and / or described with respect to 1360 of Figures 14A-14B.

[0411] Here, for example, the shape of wall 1786 includes one or more of the features shown in and / or described with respect to wall 1410 of FIGS. 14A-14C.

[0412] Here, for example, recessed upper portion 1710 includes one or more of the features shown in and / or described with respect to 1362 of FIGS. 13A-13B.

[0413] FIG. 17B shows an embodiment in which the holder 1706 is not directly connected to the push wire 1722 and / or the proximal portion(s) 1784, 1788, thereby potentially increasing the flexibility of the device 1702, for example, during delivery through a tortuous vasculature, and / or enhancing the ability of the device 1702 to conform to the shape of the aneurysm.

[0414] In some embodiments, the holder 1706 and the push wire connector 1774 are a connected, unitary molded piece (e.g., including one or more features shown in Figures 13A-13B and / or 14A-14C and / or 15A-15C and / or 16A-16B and / or described with respect to holder 1306 of Figures 13A-13B and / or holder 1406 of Figures 14A-14C and / or holder 1506 of Figures 15A-15C and / or holder 1606 of Figures 16A-16B).

[0415] FIG. 18 is a simplified schematic cross-sectional view of an expandable device 1802 according to some embodiments of the invention.

[0416] In some embodiments, the expandable device 1802 includes a wall 1810, a base 1816, and a support including a support wall 1886 and a support base 1184, the support extending around the wall 1810 and the base 1816. The support includes, for example, one or more of the features described and / or shown with respect to the support 1738 in FIG.

[0417] In some embodiments, the support wall 1886 is tubular, e.g., cylindrical, in shape and / or the expandable body 1808 has rotational symmetry about a central longitudinal axis 1899. In some embodiments, the shape of the wall 1886 includes one or more of the features described and / or shown with respect to the wall 1310 in FIGS.

[0418] In some embodiments, a push wire (not shown) is connected to the holder 1806. In some embodiments, it extends through the opening 1648. Alternatively, in some embodiments, the push wire extends in the opposite direction from the holder 1806 and is connected to and / or passes through the recessed base support portion 1888.

[0419] In some embodiments, the holder 1806 is attached to the base 1816 by a connector 1866, where in some embodiments the connector 1866 is attached to the base 1816 by one or more of crimping, welding, and hardening, and in an exemplary embodiment is attached by hardening.

[0420] In some embodiments, holder 1806 houses one or more radiation sources (not shown). In some embodiments, holder 1806 includes PEEK and / or cyanoacrylate and / or includes one or more features shown and / or described elsewhere in this document with respect to the holder(s).

[0421] Example Materials Exemplary Expandable Body Materials In some embodiments, the expandable body of the expandable device is formed from a mesh, for example a mesh composed of wires.

[0422] In some embodiments, the porosity of one or more portions of the expandable device body in the expanded configuration (e.g., in a relaxed expanded configuration within an aneurysm and / or in the expanded configuration) is 5-90%, or 10-90%, or 10-80%, or 20-80%, or 30-80%, or 20-70%, or smaller, or greater, or intermediate ranges or percentages.

[0423] In some embodiments, the pore density of one or more portions of the expandable device body in the expanded configuration (e.g., in the relaxed expanded configuration within an aneurysm and / or in the expanded configuration) is between 1 and 500, or between 5 and 400 pores / mm 2 It is.

[0424] In some embodiments, at least a portion of the wire is formed from Nitinol. In some embodiments, at least a portion of the wire is Nitinol with additional materials (also referred to herein as "composite wire"), exemplary additional materials include platinum and tantalum. For example, in some embodiments, the wire includes Nitinol and a core of a different material (e.g., platinum and / or tantalum). In some embodiments, the wire including Nitinol and additional materials is 50-80% Nitinol and 20-50% additional material (by weight and / or volume). For example, in some embodiments, the wire of the mesh includes DFT® wire (expanded filled tube) from Fort Wayne Metals Research Products Corp.

[0425] In some embodiments, the mesh includes both nitinol wire and composite wire (e.g., DFT® wire). In exemplary embodiments, at least a portion of the expandable body (e.g., the entire expandable body) is formed from 50-80% nitinol wire and 20-50% composite wire. For example, in a 96-wire device, in some embodiments, 64 of the wires are nitinol wire and 32 of the wires are composite wire.

[0426] In some embodiments, a single layer of mesh forming at least a portion of the expandable device includes between 72 and 288 wires in the layer, in some embodiments, a multi-layer mesh (e.g., a double-layer mesh) forming at least a portion of the expandable device has between 64 and 96 wires in each layer.

[0427] In an exemplary embodiment, the mesh is a woven mesh of the 1 / 2 type, where in some embodiments a wire in one direction passes under two wires and then over two wires in the other direction. Other types of mesh, e.g., 1 / 1, are also envisioned and encompassed.

[0428] In some embodiments, devices including two or more layers (e.g., layers 1610, 1662 in FIGS. 16A-16B) act to close the mesh layers and increase the wire count of the mesh. For example, in some embodiments, a single layer mesh has 64-96 wires. In some embodiments, the tight stacking of mesh layers acts to double the mesh density, e.g., for 64-96 wire layers, resulting in an effective 128-192 wire layers.

[0429] Example Connector Materials In some embodiments, the connector(s), such as one or more of connector 1266 of Figures 12C-12F, connector 1366 of Figures 13A-13C, connector 1466 of Figures 14A and 14C, connector 1566 of Figures 15A and 15C, connector 1666 of Figures 16A, connector 1766 of Figure 17B, and connector 1770 of Figure 17B, comprises a radiopaque material, such as a platinum / iridium alloy and / or tantalum. In some embodiments, the connector(s) comprises one or more of a non-radiopaque material, such as stainless steel, nitinol, titanium, cobalt chromium (CoCr) alloy, polymer (e.g., PEEK and / or polyimide).

[0430] Example source and example source attachment In many embodiments, the source is attached to a holder. In some embodiments, one or more characteristics of the holder in this section include feature(s) described and / or shown with respect to the exemplary holders referred to in this document, such as holder 1106 of Figure 11, and / or holder 1206 of Figures 12A-12H, and / or holder 1606 of Figures 16A-16B.

[0431] FIG. 19A is a simplified schematic diagram of a source holder 1906 according to some embodiments of the present invention.

[0432] FIG. 19B is a simplified schematic diagram of a radiation source 1904 according to some embodiments of the present invention.

[0433] FIG. 19C is a simplified schematic diagram of a radiation source 1904 connected to a source holder 1906, according to some embodiments of the present invention.

[0434] In some embodiments, FIG. 19C shows the source holder 1906 of FIG. 19A and the source 1904 of FIG. 19B.

[0435] Reference is now made to Figure 19B, which illustrates an exemplary source 1904. In some embodiments, the source 1904 (e.g., for a device(s) described in this document) has a body that includes a first material that has been treated with a radioactive material.

[0436] In some embodiments, the shape of the source body 1904 is elongated in one or more directions (e.g., as shown in Figures 19A-19C). In some embodiments, the source body(s) 1904 are spherical, rod-shaped, or coiled (e.g., as described later in this section).

[0437] In some embodiments, the body is treated with (e.g., a source of) one or more radioisotopes, e.g., Pd-103 and / or I-125, where, for example, treatment includes coating the body with a material containing the radioisotope, and / or ion implantation, and / or radioactivation by proton and / or neutron bombardment.

[0438] In exemplary embodiments, the body includes (e.g., is formed from) rhodium, where in some embodiments the rhodium has been treated (e.g., by proton bombardment in a cyclotron, etc.) to include the radioactive Pd-103 isotope.

[0439] In some embodiments, the source comprises an encapsulated seed.

[0440] In some embodiments, the radiation source includes commercially available brachytherapy seeds, such as ISOAID Advantage™ IAI-125A, ISOAID Advantage™ IAPd-103A.

[0441] In some embodiments, the source comprises an (optionally encapsulated) seed that is 0.05-2 mm, or 0.1 mm-1 mm, or smaller, or larger, or intermediate sizes or ranges in at least one dimension, e.g., 0.05-2 mm, or 0.1-1 mm, or smaller, or larger, or intermediate sizes or ranges in two dimensions, e.g., 0.05-2 mm, 0.1-1 mm, or smaller, or larger, or intermediate sizes or ranges in all three dimensions.

[0442] In some embodiments, the release of the expandable device from the source is selected based on the size of the aneurysm being treated, the shielding of the expandable device when the device is within the aneurysm being treated, and the location of the source relative to the device and / or aneurysm when the device is in place.

[0443] For example, mention is made of devices with widths of 5 mm, 7 mm, 9 mm, 11 mm, and 14 mm.

[0444] In some embodiments, the source length of an exemplary device is selected based on a dimension(s) of the device, where in some embodiments, one or more source characteristics (e.g., cross-sectional dimension of the source, radiation per volume, and / or surface area) remain unchanged, where, for example, in some embodiments, a kit including devices of various sizes has sources scaled (e.g., by length) proportionally to one or more dimensions of the device, e.g., in a relaxed expanded configuration and / or an expanded configuration with an aneurysm.

[0445] For example, in some embodiments, one or more dimensions of the device, such as the expanded width and / or length and / or depth of the device, is 1 to 20 times, or 1 to 10 times, or 2 to 10 times, or a smaller, or larger, or intermediate multiple, of the length of the central longitudinal axis of the source.

[0446] For example, in some embodiments, a device with a width and / or length of 5 mm has a source length of 0.5 to 2 mm. For example, in some embodiments, a device with a width and / or length of 7 mm has a source length of 1 to 3 mm. For example, in some embodiments, a device with a width and / or length of 9 mm has a source length of 1.5 to 4 mm. For example, in some embodiments, a device with a width and / or length of 11 mm has a source length of 3 to 7 mm. For example, in some embodiments, a device with a width and / or length of 14 mm has a source length of 3.5 to 10 mm.

[0447] In some embodiments, the source holder 1906 includes a lumen 1964 configured to receive one or more sources. In some embodiments, the holder 1906 includes arms 1936 (e.g., including one or more features shown in and / or described with respect to arms 1136 of FIG. 11 ). In some embodiments, the source holder 1906 includes openings 1937 in the material of the holder, potentially allowing radiation that is not attenuated by the material of the holder to escape through these openings.

[0448] In some embodiments, the holder 1906 includes a radiation blocking material in one or more regions of the holder, potentially allowing for control of the directionality of the radiation. For example, in some embodiments, radiation is blocked in a direction toward the optic nerve(s).

[0449] 19C, in some embodiments, the source 1904 remains within the holder 1906 at one or more ends of the holder due to a size and / or shape match between the holder lumen 1964 and the source 1904, e.g., the holder walls are stretched during insertion of the source 1904 into the lumen 1964. Alternatively or additionally, the holder is closed at one or both ends, e.g., by a cap(s), and / or is deformed such that the size of the lumen 1964 is reduced, potentially preventing the source from slipping out of the holder.

[0450] In some embodiments (e.g., as shown in FIGS. 19A-19B ), the source 1904 has a length that is shorter than the holder lumen 1904. In some embodiments, the position of the source 1904 along the length of the holder 1906 is selected, for example, prior to insertion of the device into a subject.

[0451] FIG. 20A is a simplified schematic diagram of a source holder 2006 according to some embodiments of the present invention.

[0452] FIG. 20B is a simplified schematic diagram of a radiation source 2004 according to some embodiments of the present invention.

[0453] FIG. 20C is a simplified schematic diagram of a radiation source 2004 connected to a source holder 2006, according to some embodiments of the present invention.

[0454] In some embodiments, the source 2004 is attached to the outside of the holder 2006. In an exemplary embodiment, the source 2004 is an elongated element that is positioned by wrapping it around the holder 2006. In some embodiments, the source 2004 is a coil, e.g., a wire as shown in FIG. 20B, that is pressed onto the support 2006. In some embodiments, the inner diameter(s) of the source 2004 (and / or source 2104) is smaller than the outer diameter(s) of the support 2006, and the source is deformed (elastically and / or plastically) to attach to the support 2006. In some embodiments, a reaction force acts to hold the source 2004 (and / or source 2104) in place on the support 2006.

[0455] In some embodiments, multiple sources are attached to support 2006 in such a manner, for example including one or more of the features shown in and / or described with respect to Figures 29A-29B.

[0456] 21 is a simplified schematic diagram of a radiation source 2104 according to some embodiments of the present invention. In some embodiments, the radiation source is a tape coil 2104. In some embodiments, the radiation source 2104 is connected to a support that includes one or more of the features shown and / or described with respect to the attachment of the radiation source 2024 to the support 2006 in, for example, FIGS. 20A-20C. In some embodiments, the tape coil 2104 and / or wire coil 2004 source is attached to the holder by being inserted into a lumen of the holder, and in some embodiments is held in the lumen by a cap and / or distortion of the lumen.

[0457] FIG. 22A is a simplified schematic diagram of a radiation source 2204, a source holder 2406, and a source holder cap 2234, according to some embodiments of the present invention.

[0458] FIG. 22B is a simplified schematic diagram of a radiation source 2204 connected to a source holder 2206, according to some embodiments of the present invention.

[0459] In some embodiments, the source 2204 is held in the holder lumen 2264 by the cap 2234, where in an exemplary embodiment the cap 2234 is secured to the holder 2206 by threading, where the cap 2234 and / or the holder 2206 include threads 2297. Alternatively or additionally, in some embodiments, the cap 2234 is glued in place. Alternatively or additionally, in some embodiments, the cap 2234 is sized and / or shaped to have a portion that is insertable into the lumen 2264 but difficult to remove, e.g., providing an interference fit with the holder 2206. In some embodiments, the cap 2234 is closed and / or closes the lumen 2264. Alternatively, in some embodiments, the cap includes one or more openings that are too small to allow passage of the source 2204.

[0460] Optionally, in some embodiments, element 2204 shown in FIGS. 22A-22B is a second holder, in which case a source is attached to the exterior of element 2204, and both element 2204 and a source coupled to element 2204 (e.g., a wound coil source, etc.) are held within lumen 2264.

[0461] 23-26 show exemplary positions of the radiation source relative to the holder and / or connector in some embodiments.

[0462] In some embodiments, like elements in Figures 23-26 are indicated with like reference numbers, e.g., element 2304 corresponds to element 2504, where "similar" is defined herein as sharing one or more features shown in the figure(s) and / or described with respect to the figures in the body of the application.

[0463] FIG. 23 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the invention.

[0464] In some embodiments, a portion of the expandable body 2308 of the expandable device is held by a connector 2366 (e.g., closed at the base or top), where in some embodiments the connector 2366 has a ring shape. In some embodiments the connector 2366 is attached by one or more of crimping, welding, and quenching. In some embodiments, the holder 2306 is attached to the expandable body 2308 by the connector 2366, e.g., the expandable body 2308 is disposed between the holder 2306 and the connector 2366 (e.g., as shown in FIG. 23). Optionally, in some embodiments the connector comprises a radiopaque material.

[0465] Optionally, in some embodiments, the holder 2306 provides a connection to the push wire 2322 of the expandable device. In some embodiments, the connection is made through a separation region 2392, where in some embodiments, the separation region 2392 is configured to be weakened by one or more of electrolytically and electrothermally to release a proximal portion of the push wire 2322 from the expandable device. In some embodiments, the separation region 2392 includes a mechanical attachment that in some embodiments is released to remove the push wire 2322. In some embodiments, the mechanical attachment includes a screw attachment that rotates and removes the push wire. In some embodiments, the mechanical attachment includes a pull and / or push wire actuation release, and the device includes an additional control wire that extends through the catheter, for example, for control by the user.

[0466] In some embodiments, the holder 2306 provides electrical insulation between the separation region 2392 and / or the push wire 2322 and the expandable body 2308 (and / or other regions of the device). A potential benefit is that the push wire can be removed using an electrical stimulus without irritating the rest of the device.

[0467] In some embodiments, the source 2304 is attached, e.g., externally, to a holder 2306 that includes one or more features as described with respect to the source 2004, 2104 and holder 2006 of Figures 20A-20C and 21. Alternatively or additionally, the source is attached to the holder 2306 by being at least partially inserted into an internal lumen of the holder (e.g., as described and / or shown with respect to the holder 1106 of Figure 11 and / or the holder 1906 and / or source 1904 of Figures 19A-19C).

[0468] In some embodiments, the radiation source 2304 is attached to a portion of the holder 2306 distal to the holder's connection to the expandable body 2308, potentially positioning the radiation source 2304 in a central region of the device, e.g., as described elsewhere in this document.

[0469] In some embodiments, connector 2366 includes a radiopaque material, meaning that it potentially blocks radiation emitted distally by source 2304. In some embodiments, the source is located proximal and / or external to connector 2366.

[0470] FIG. 24 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the present invention.

[0471] 24 illustrates an embodiment in which the radiation source 2404 is attached to the exterior of the holder 2406, between the holder 2406 and the connector 2466 and / or mesh of the expandable body 2408. If the connector 2466 includes a radiopaque and / or radiation attenuating material, the location of the radiation source 2404 within the connector 2466 may reduce radiation emitted (and received by tissue) in a direction perpendicular to the proximal-distal direction (when the push wire 2422 is located at the proximal end of the view of FIG. 24 and extends distally) and / or in the axial direction (with respect to the ring connector 2466).

[0472] FIG. 25 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the invention.

[0473] In some embodiments, the source 2504 is mounted externally to the connector 2466. The connector potentially reduces attenuation of radiation emitted from the source 2504, as opposed to the configuration shown in, for example, FIG.

[0474] FIG. 26 is a simplified schematic diagram of a portion of an expandable device according to some embodiments of the invention.

[0475] In some embodiments, the radiation source 2604 is attached proximally to the connector 2666. If the connector 2466 includes a radiation attenuating material, this proximal attachment of the source means that radiation directed in a proximal direction, for example toward the neck of the aneurysm, is not attenuated by the connector 2666.

[0476] Exemplary Multiple Sources and / or Multiple Source Devices FIG. 27 is a simplified schematic cross-sectional view of an expandable device 2702 according to some embodiments of the invention.

[0477] In some embodiments, the expandable device 2702 includes multiple radiation sources 2704a, 2704b. In some embodiments, one or more of the radiation sources 2704a are selected and / or positioned for irradiation of the aneurysm sac and / or interior volume. In some embodiments, one or more of the radiation sources 2704b are selected for irradiation of the aneurysm neck region. In some embodiments, the multiple radiation sources 2704a, 2704b are contained by a single holder 2706.

[0478] FIG. 28 is a simplified schematic cross-sectional view of an expandable device 2802 according to some embodiments of the invention.

[0479] In some embodiments, the expandable device 2802 includes multiple radiation sources 2804a-d. In some embodiments, one or more expandable elements 2863 are configured to position a radiation source 2804c attached to the expandable element 2863, for example, within a volume defined by the expandable body 2808. In some embodiments, each radiation source 2804a-d is connected to the holder 2806 by a separate expandable element (e.g., as shown in FIG. 28).

[0480] Example shielding For example, connector 2246 of Figures 22A-22B, for example, has been described with respect to blocking radiation, as described elsewhere herein. In some embodiments, the source is shielded from radiation emission in one or more directions, where in some embodiments, shielding includes attenuating the emitted radiation to cause a reduction in dose and / or dose rate in one or more directions, where in some embodiments, shielding includes blocking the emitted radiation.

[0481] In some embodiments, a radiopaque material is used to shield the connector 2246, including, for example, platinum.

[0482] In some embodiments, doped PMMA is used for shielding, including, for example, one or more features described and / or exemplified in Nuclear Engineering and Technology, Volume 52, Issue 11, November 2020, Pages 2613-2619 “Gamma radiation shielding properties of poly (methyl methacrylate) / Bi2O3 composites” by Da Cao, Ge Yang, Mohamed Bourham, Dan Moneghan, which is incorporated herein by reference in its entirety.

[0483] Example radiation levels In some embodiments, the total dose is measured using one or more techniques known in the art of radiation source measurement, for example, the total dose is measured from the source by using one or more of the source isotope half-life, the known radioactivity, and the measurement time, for example, using the TG-43 algorithm known in the art of radiation source dose calculations.

[0484] In some embodiments, the neck of the aneurysm receives a desired dose, for example, 10-40 Gy (and / or doses described elsewhere in this document).

[0485] In some embodiments, the desired dose received is related to one or more of a number of device attributes, such as where, for a given source, the dose received at the neck of the aneurysm is related to the distance from the neck to the source and the strength of any shielding between the source and the neck, where in some embodiments the shielding is provided by the material of the expandable body and / or one or more additional elements (e.g., markers, connectors).

[0486] Here, in some embodiments, the possible distance from the source to the neck is defined by the size of the aneurysm and / or the maximum radiation dose that the tissue outside the aneurysm should tolerate, where the radiation dose received by the tissue outside the aneurysm is also affected by any shielding between the source and the tissue (e.g., provided by the body of the expandable device therebetween). In some embodiments, the neck is 1-10 mm from the source.

[0487] In some embodiments, the radiation source(s) for the devices described herein and / or exemplary radiation dose(s) and / or dose rate(s) for treatment (e.g., of an aneurysm) include one or more features described and / or illustrated with respect to the seed(s) and / or source in U.S. Patent Publication No. US2020 / 0078602, the entirety of which is incorporated herein by reference.

[0488] In some embodiments, one or more portions of the expandable body absorb 10-90%, or 20-80%, or 30-70%, or a smaller, greater, or intermediate percentage or range. In some embodiments, one or more portions of the expandable body absorb 20-80% of the radiation emitted from the source incident on the expandable body, or a smaller, greater, or intermediate percentage of the radiation emitted from the source. For the exemplary doses listed below, in some embodiments, if the mesh is placed less than 5 mm away from the outer surface of the source, the listed dose levels are reduced by 20-80% at 5 mm and 10 mm, and in some embodiments, this reduction reflects absorption by the expandable body of the device. If the mesh is placed between 5 mm and 10 mm, in some embodiments, the dose level listed at 10 mm is reduced by 20-80%.

[0489] In some embodiments, the radiation source provides a dose of 100-500 Gy, or a lower, higher, or intermediate range or dose, at 0-1 mm from the outer surface of the source. In some embodiments, the radiation source provides a dose of 5-130 Gy, or a lower, higher, or intermediate range or dose, at 5 mm from the outer surface of the source. In some embodiments, the radiation source provides a dose of 1-20 Gy, or a lower, higher, or intermediate range or dose, at 10 mm from the outer surface of the source.

[0490] In some embodiments, the radiation source provides a dose of 100-500 Gy, or a lower, higher, or intermediate range or dose, at 0-1 mm from the outer surface of the source, a dose of 5-130 Gy, or a lower, higher, or intermediate range or dose, at 5 mm from the outer surface of the source, and a dose of 1-20 Gy, or a lower, higher, or intermediate range or dose, at 10 mm from the outer surface of the source.

[0491] In some embodiments, the radiation source provides a dose of 100-500 Gy, or a lower, higher, or intermediate range or dose, at 0-1 mm from the outer surface of the source, a dose of 15-75 Gy, or a lower, higher, or intermediate range or dose, at 5 mm from the outer surface of the source, and a dose of 2-10 Gy, or a lower, higher, or intermediate range or dose, at 10 mm from the outer surface of the source.

[0492] In some embodiments, the radiation source provides a dose of 100 Gy at 0-1 mm from the outer surface of the source, a dose of 15 Gy at 5 mm from the outer surface of the source, and a dose of 2 Gy at 10 mm from the outer surface of the source.

[0493] In some embodiments, the radiation source provides a dose of 200 Gy at 0-1 mm from the outer surface of the source, a dose of 30 Gy at 5 mm from the outer surface of the source, and a dose of 4 Gy at 10 mm from the outer surface of the source.

[0494] In some embodiments, the radiation source provides a dose of 300 Gy at 0-1 mm from the outer surface of the source, a dose of 45 Gy at 5 mm from the outer surface of the source, and a dose of 6 Gy at 10 mm from the outer surface of the source.

[0495] In some embodiments, the radiation source provides a dose of 400 Gy at 0-1 mm from the outer surface of the source, a dose of 60 Gy at 5 mm from the outer surface of the source, and a dose of 8 Gy at 10 mm from the outer surface of the source.

[0496] In some embodiments, the radiation source provides a dose of 500 Gy at 0-1 mm from the outer surface of the source, a dose of 75 Gy at 5 mm from the outer surface of the source, and a dose of 10 Gy at 10 mm from the outer surface of the source.

[0497] In some embodiments, the radiation source provides a dose of 100-500 Gy, or a lower, higher, or intermediate range or dose, at 0-1 mm from the outer surface of the source, a dose of 30-150 Gy, or a lower, higher, or intermediate range or dose, at 5 mm from the outer surface of the source, and a dose of 4-20 Gy, or a lower, higher, or intermediate range or dose, at 10 mm from the outer surface of the source.

[0498] In some embodiments, the radiation source provides a dose of 100 Gy at 0-1 mm from the outer surface of the source, a dose of 30 Gy at 5 mm from the outer surface of the source, and a dose of 4 Gy at 10 mm from the outer surface of the source.

[0499] In some embodiments, the radiation source provides a dose of 200 Gy at 0-1 mm from the outer surface of the source, a dose of 60 Gy at 5 mm from the outer surface of the source, and a dose of 8 Gy at 10 mm from the outer surface of the source.

[0500] In some embodiments, the radiation source provides a dose of 300 Gy at 0-1 mm from the outer surface of the source, a dose of 90 Gy at 5 mm from the outer surface of the source, and a dose of 12 Gy at 10 mm from the outer surface of the source.

[0501] In some embodiments, the radiation source provides a dose of 400 Gy at 0-1 mm from the outer surface of the source, a dose of 120 Gy at 5 mm from the outer surface of the source, and a dose of 16 Gy at 10 mm from the outer surface of the source.

[0502] In some embodiments, the radiation source provides a dose of 500 Gy at 0-1 mm from the outer surface of the source, a dose of 150 Gy at 5 mm from the outer surface of the source, and a dose of 20 Gy at 10 mm from the outer surface of the source.

[0503] In some embodiments, the radiation source provides a dose of 100-500 Gy, or a lower, higher, or intermediate range or dose, at 0-1 mm from the outer surface of the source, a dose of 5-25 Gy, or a lower, higher, or intermediate range or dose, at 5 mm from the outer surface of the source, and a dose of 2-5 Gy, or a lower, higher, or intermediate range or dose, at 10 mm from the outer surface of the source.

[0504] In some embodiments, the radiation source provides a dose of 100 Gy at 0-1 mm from the outer surface of the source, a dose of 5 Gy at 5 mm from the outer surface of the source, and a dose of 1 Gy at 10 mm from the outer surface of the source.

[0505] In some embodiments, the radiation source provides a dose of 200 Gy at 0-1 mm from the outer surface of the source, a dose of 10 Gy at 5 mm from the outer surface of the source, and a dose of 2 Gy at 10 mm from the outer surface of the source.

[0506] In some embodiments, the radiation source provides a dose of 300 Gy at 0-1 mm from the outer surface of the source, a dose of 15 Gy at 5 mm from the outer surface of the source, and a dose of 3 Gy at 10 mm from the outer surface of the source.

[0507] In some embodiments, the radiation source provides a dose of 400 Gy at 0-1 mm from the outer surface of the source, a dose of 20 Gy at 5 mm from the outer surface of the source, and a dose of 4 Gy at 10 mm from the outer surface of the source.

[0508] In some embodiments, the radiation source provides a dose of 500 Gy at 0-1 mm from the outer surface of the source, a dose of 25 Gy at 5 mm from the outer surface of the source, and a dose of 5 Gy at 10 mm from the outer surface of the source.

[0509] In some embodiments, the radiation source(s) of the expandable device (e.g., the expandable devices described herein) are configured to irradiate the aneurysm sac and / or neck region while minimizing radiation to tissue outside the aneurysm. For example, if an aneurysm has an average (and / or maximum) dimension of 5 mm, in some embodiments, the radiation dose at 5 mm from the source central axis is 15% of the dose at 1 mm from the source central axis. In some embodiments, the radiation dose at 10 mm away from the source central axis and / or outer surface of the source is 0.5% of the dose at 1 mm from the source.

[0510] In some embodiments, the radiation source is 0.1-10 mm, or 1-5 mm long, or smaller, or larger, or intermediate ranges or lengths. In some embodiments, the radiation source is elongated. In some embodiments, the width (e.g., the maximum and / or average cross-sectional dimension taken perpendicular to the length of the source) is 0.1-1 mm, or 0.15-0.5 mm wide, or larger, or smaller, or intermediate ranges or widths. In some embodiments, the radiation source is 0.1-10 mm long and 0.1-1 mm wide. In some embodiments, the radiation source is 1-5 mm long and 0.15-0.5 mm wide.

[0511] In some embodiments, the radiation source includes iodine-125 (I-125), such as an I-125 seed encapsulated in titanium. In some embodiments, the seeds have an average and / or maximum cross-sectional dimension (e.g., diameter) of 0.5-1 mm and / or a length of 5-10 mm. In some embodiments, the radiation source is a commercially available iodine-125 brachytherapy seed manufactured for use in brain brachytherapy.

[0512] In some embodiments, the radiation dose at 5 mm from the source central axis is 15% of the value at 1 mm, and the dose at 10 mm is 4% of the dose at 1 mm.

[0513] In some embodiments, the radiation source includes palladium-103, where in some embodiments the radiation dose 10 mm from the outer surface of the source is 0.5% of the dose at 1 mm from the source.

[0514] In some embodiments, the energy of the gamma isotope is 20-30 KeV. In some embodiments, all radiation is absorbed at 4-15, or 10-15 mm, or smaller, larger, or intermediate distances or ranges from the source. In some embodiments, the radiation dose received by tissue at 4-15, or 10-15 mm, or smaller, larger, or intermediate distances or ranges from the outer surface of the source is less than 1% of the total dose received by the tissue.

[0515] FIG. 38 shows a table illustrating exemplary dose rates, according to some embodiments of the present invention.

[0516] In some embodiments, exemplary doses of two exemplary isotopes, I-125 and Pd-103, are shown, where in some embodiments, each column of each table shows three exemplary embodiments of different dose rates for three different distances from the surface of an exemplary source. In some embodiments, for each time period after ion implantation, the values ​​in one column relate to the values ​​of similarly placed columns at different time periods. For example, referring to the first example in the first column of the first table, an I-125 source irradiates at 50 mGy / hr at 0-1 mm, 7.5 mGy / hr at 5 mm, and 1 mGy / hr at 10 mm on day 1 after ion implantation, and in some embodiments, the same source irradiates at 37.5 mGy / hr at 0-1 mm, 5.625 mGy / hr at 5 mm, and 0.75 mGy / hr at 10 mm on day 30 after ion implantation. In some embodiments, all values ​​within the tables and / or within this section of the document are approximate and are understood to be + / - 20% of the stated value.

[0517] Additional Exemplary Embodiments Patent document EP3136986 (hereby incorporated by reference in its entirety) shows a device for treating vascular deformities (eg, aneurysms).

[0518] In some embodiments, the exemplary source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Mounting") are attached to a structure(s) described in EP3136986 (e.g., including one or more of the mounting methods and / or structures described in this document in the section entitled "Exemplary Sources and Exemplary Source Attachments").

[0519] FIG. 29A is a simplified schematic diagram of an expandable device 2902 according to some embodiments of the invention.

[0520] FIG. 29B is a simplified cross-sectional schematic of an expandable device 2902 within an aneurysm, according to some embodiments of the present invention.

[0521] In some embodiments, the expandable device 2902 includes an expandable body 2908, which in some embodiments includes, e.g., is formed from, a mesh, where in some embodiments, an open end of the tubular mesh structure is closed by a connector 2966. In some embodiments, the connector 2966 attaches the holder 2906 to the expandable body 2908. In some embodiments, the connector 2966 is connected to a delivery apparatus (e.g., including a push wire), which in some embodiments is detached after deployment of the device. In some embodiments, the holder 2906 houses one or more radiation sources 2904. Alternatively or additionally, in some embodiments, the radiation sources 2904 are attached directly to the expandable body 2098. In some embodiments, the expandable body 2908 includes a wall 2910, which in some embodiments, at least partially conforms to the shape of the inner wall of the aneurysm 2926. In some embodiments, the expandable body 2908 includes a base portion 2916 (e.g., a formed mesh), for example, to which the wall 2910 is connected by the base 2916. In some embodiments, the connector 2966 is connected to the base portion 2916. In some embodiments, expansion of the expandable body 2908 (e.g., elastic) in a direction away from the connector and / or base holds the device 2902 in place within the aneurysm 2926 and (at least partially) covers the mouth of the aneurysm 2926.

[0522] In some embodiments, the device 2902 is symmetric about one or more axes (e.g., in a relaxed, expanded configuration), in which case, for example, the 3D geometry of the device is formed, in some embodiments, by rotating the cross-section shown in FIG. 29A about a central proximal-distal axis 2999.

[0523] Patent document US20190269414 (herein incorporated by reference in its entirety) shows a device for treating vascular deformations (e.g., aneurysms).

[0524] In some embodiments, the exemplary source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Mounting") are attached to a structure(s) described in US20190269414 (e.g., including one or more of the mounting methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document).

[0525] FIG. 30A is a simplified schematic diagram of an expandable device 3002 according to some embodiments of the invention.

[0526] FIG. 30B is a simplified cross-sectional schematic diagram of an expandable device 3002 within an aneurysm 3026, according to some embodiments of the present invention.

[0527] In some embodiments, the device 3002 includes multiple expandable portions 3008 connected to each other by connectors 3066. In some embodiments, one or more of the connectors 3066 (FIG. 30A), 3066a-3066d (FIG. 30B) (e.g., the most proximal of the connectors 3066, e.g., 3066d in FIG. 30B) are connected to a delivery device (e.g., including a push wire), which in some embodiments is detached after deployment of the device. Here, in some embodiments, the expandable portions include a mesh, e.g., are formed of a mesh. In some embodiments, the mesh of each expandable portion has the same properties. Alternatively, in some embodiments, the mesh of one or more of the expandable portions 3008 have different properties, e.g., relaxed configuration dimension(s) and / or porosity and / or mesh material. In some embodiments, the individual expandable portions separately conform to the shape of the aneurysm 3026. For example, each expandable portion 3008 varies in length and / or width to conform to the aneurysm. In some embodiments, one or more portions of the expandable device 3002 are connected to a radiation source (e.g., exemplary radiation sources and / or radiation source attachments described elsewhere in this document), where in some embodiments, one or more connectors 3066 (FIG. 30A), 3066a-3066d (FIG. 30B) are radiation sources and / or house one or more radiation sources and / or are attached to a holder that houses one or more radiation sources. In some embodiments, the central connector is and / or houses the radiation source(s), e.g., connector 3066b and / or connector 3066c. In some embodiments, only the connector(s) located in the central region of the device 3002 are and / or house a radiation source.

[0528] Patent document US9629635 (hereby incorporated by reference in its entirety) shows a device for treating vascular deformities (eg, aneurysms).

[0529] In some embodiments, the exemplary source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Mounting") are attached to a structure(s) described in US9629635 (e.g., including one or more of the mounting methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document).

[0530] FIG. 31 is a simplified cross-sectional schematic diagram of an expandable device 3102 within an aneurysm 3126, according to some embodiments of the present invention.

[0531] In some embodiments, the expandable device 3102 includes an expandable body 3108 connected to a cover 3116, where in some embodiments, one or both of the body 2108 and the cover 3116 include (e.g., are formed of) a mesh. In some embodiments, the expandable body 3108 is expanded within the aneurysm 3126, where in some embodiments, the sizing and / or relaxation force of the expandable body on the aneurysm wall holds the body 3108 in place within the aneurysm 3126. In some embodiments, the cover 3116 is sized and / or shaped to cover the aneurysm mouth of the aneurysm 3126. In some embodiments, the cover 3116 is positioned outside the aneurysm mouth of the aneurysm and / or the cover 3116 is in an elastically relaxed state when the device is properly positioned, for example as shown in FIG. 31 . Alternatively, in some embodiments, the cover 3116 is configured to at least partially conform to the shape of the blood vessel in the region of the aneurysm mouth. In this case, in some embodiments, the cover shown in FIG. 31 applies an expansion force to the portion(s) of the vascular wall with which it is in contact. In some embodiments, tension between the connection between the cover and the expandable body 3108 holds the cover in place against the vascular tissue at the mouth of the aneurysm. In some embodiments, the device 3102 is symmetrical about one or more axes (e.g., in a relaxed expanded configuration), where, for example, the 3D geometry of the device is formed, in some embodiments, by rotating the cross-section shown in FIG. 31 about a central proximal-distal axis 3199. In some embodiments, the device 3102 includes one or more connectors 3166. Here, in some embodiments, the connector(s) 3166 (e.g., the most proximal connector(s) 3166) close the open area(s) of the tubular mesh and / or hold the shape of the device 3102 in place (e.g., including the folded-over portion(s)). In some embodiments, the connector(s) 3166 are connected to a delivery apparatus (eg, including a push wire), which in some embodiments is detached after deployment of the device.In some embodiments, one or more of the connector(s) is a radiation source (e.g., as described herein) and / or houses a radiation source (e.g., externally and / or within a lumen) and / or is attached to a holder that houses one or more radiation sources. In some embodiments, only the connector(s) located in the central region of the device 3102 is and / or houses a radiation source.

[0532] Patent document US20170367708 (herein incorporated by reference in its entirety) shows a device for treating vascular deformations (e.g., aneurysms).

[0533] In some embodiments, the exemplary source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Mounting") are attached to a structure(s) described in US20170367708 (e.g., including one or more of the mounting methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document).

[0534] FIG. 32 is a simplified schematic diagram of an expandable device within an aneurysm, according to some embodiments of the present invention.

[0535] In some embodiments, the device 3202 includes an elongated portion (e.g., a wire) that coils through space to define the shape of the device 3202 when in a relaxed configuration (e.g., the device 3202 is formed of the elongated portion). In some embodiments, the device 3202 includes a body 3208 and a cover 3216, where the body and / or cover includes one or more features shown and / or described with respect to the cover 3216 and / or the body 3208. In some embodiments, the device 3216 includes a connector 3266. In some embodiments, the connector 3266 connects the cover 3216 to the body 3208. In some embodiments, the connector 3266 is connected to a delivery device (e.g., including a push wire), which in some embodiments is detached after deployment of the device. In some embodiments, the connector 3266 includes one or more radiation sources 3204. Alternatively or additionally, in some embodiments, the connector 3266 houses one or more radiation sources 3204. In some embodiments, the connector 3266 is connected to a holder 3206 that houses the radiation source 3204. In some embodiments, the radiation source is optionally connected proximally to the connector 3266 by a holder, for example, where the connector 3266 is radiopaque.

[0536] Patent document US20180140305 (herein incorporated by reference in its entirety) shows a device for treating vascular deformations (e.g., aneurysms).

[0537] In some embodiments, the exemplary source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Mounting") are attached to a structure(s) described in US20180140305 (e.g., including one or more of the mounting methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document).

[0538] FIG. 33 is a simplified schematic diagram of an expandable device 3302 within an aneurysm 3326, according to some embodiments of the present invention.

[0539] In some embodiments, the expandable device 3302 includes an outer body 3308a, where in some embodiments the outer body 3308a expands to conform to the shape of the aneurysm 3326. In some embodiments the outer body 3308a includes (e.g., is formed of) a mesh. Optionally, in some embodiments, the device 3302 includes an inner body 3308b. In some embodiments the inner body 3308b is positioned to provide a double layer of mesh at the aneurysm mouth of the aneurysm 3326. In some embodiments the inner body 3308b is attached to the outer body 3308b, for example, to position the inner body 3308b at the aneurysm mouth of the aneurysm. In some embodiments the inner body 3308b is delivered and / or expanded separately from the outer body 3308b.

[0540] In some embodiments, one or more portions of the outer body 3308a and / or inner body 3308b are the radiation source. In exemplary embodiments, the inner body 3308b includes a radiation source, e.g., in some embodiments, the mesh of the inner body 3308b (e.g., the mesh of the entire inner body 3308b in some embodiments) is the radiation source. For example, as described elsewhere in this document, in some embodiments, a portion of the body of the radioactive device is itself the radiation source, e.g., at least a portion of the mesh is treated, e.g., in some embodiments, to be a radiation source, the emission of which follows the description of radiation sources elsewhere in this document. In some embodiments, a portion of the mesh body is the radiation source, e.g., when the treatment includes one or more features of the treatments described elsewhere in this document.

[0541] Patent document JP2019526324A (herein incorporated by reference in its entirety) shows a device for treating vascular deformation (e.g., aneurysms).

[0542] In some embodiments, the exemplary radiation source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Attachment") are attached to a structure(s) described in JP2019526324A (e.g., including one or more of the attachment methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document) and / or are attached to a commercially available device for treatment of the LAA, e.g., a device(s) manufactured by Boston Scientific, e.g., Watchman™.

[0543] FIG. 34 is a simplified schematic diagram of an expandable device 3402 within an aneurysm 3426, according to some embodiments of the present invention.

[0544] In some embodiments, for example, the expandable device 3402, which positions and / or maintains the device in place, includes one or more features described with respect to the expandable device 2902 of FIGS. 29A-29B. In some embodiments, the device 3402 includes a support structure 3440. In some embodiments, the support structure 3440 is expandable, e.g., elastically expandable. In some embodiments, the support structure 3440 is formed from an elongated element(s), e.g., a wire. In some embodiments, the support structure is at least partially covered by a body 3408, where in some embodiments, the body 3408 includes (e.g., is formed from) a mesh. Alternatively or additionally, in some embodiments, the body 3408 includes a polymer layer. In some embodiments, at least a portion of the body 3408 includes a radioactive material, e.g., a source of radiation. Alternatively or additionally, in some embodiments, the radiation source 3404 (or multiple sources) is attached to the support 3440 and / or the body 3408 directly and / or via a holder 3406 that houses the radiation source 3404 .

[0545] In some embodiments, the device 3402 includes a distal support structure (not shown) that includes one or more features of the distal support structure 1682 shown in and / or described with respect to Figures 16A-16B.

[0546] In some embodiments, the exemplary radiation source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Attachment") are attached to a commercially available aneurysm treatment device(s) manufactured by Medtronic, such as the ARTISSE™ (e.g., including one or more of the attachment methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachment" of this document).

[0547] FIG. 35 is a simplified schematic cross-sectional view of an expandable device 3502 according to some embodiments of the invention.

[0548] In some embodiments, the device 3502 is symmetric about one or more axes (e.g., in a relaxed, expanded configuration), in which case, for example, the 3D geometry of the device is formed, in some embodiments, by rotating the cross-section shown in FIG. 35 about a central proximal-distal axis 3599.

[0549] In some embodiments, the device 3502 includes an expandable body 3508 that includes one or more features described and / or illustrated with respect to the expandable body elsewhere in this document. In some embodiments, the expandable body 3508 includes a wall 3510 (e.g., a tubular wall 3510) and a base 3516. In some embodiments, the expandable body 3508 includes a mesh (e.g., is formed from a mesh). In some embodiments, the expandable body 3508 includes an upper portion 3540 where the mesh structure at the upper portion is not open and / or is not closed with a connector. Optionally, in some embodiments, the mesh ends that meet at a central region of the base 3516 are connected by a connector 3566. In some embodiments, the connector 3566 connects a removable delivery apparatus (not shown) to the device 3502. In some embodiments, one or more radiation sources 3504 are connected to the expandable body 3508, for example, directly by the connector 3566 and / or via the holder 3506. Here, in some embodiments, the holder 3506 includes one or more features shown in figures associated with this document and / or described with respect to the holder(s) elsewhere in this document.

[0550] Patent document US9629635 (hereby incorporated by reference in its entirety) shows a device for treating vascular deformities (eg, aneurysms).

[0551] In some embodiments, the exemplary radiation source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Attachment") are attached to device(s) described in US9629635 (e.g., including one or more of the attachment methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document) and / or are attached to commercially available devices for treating aneurysms, such as device(s) manufactured by the Terumo Group, e.g., Woven EndoBridge® WEB™ SL and / or WEB™ SLS.

[0552] FIG. 36 is a simplified schematic cross-sectional view of an expandable device 3602 according to some embodiments of the invention.

[0553] In some embodiments, the device 3602 includes an expandable body 3608 having a tubular wall 3610, with proximal and distal ends of the wall connected by connectors 3666a and 3666b, respectively, to form a base portion 3616 and a top portion 3640, respectively. In some embodiments, the device 3602 is symmetric about one or more axes (e.g., in a relaxed, expanded configuration), where, for example, the 3D geometry of the device is formed in some embodiments by rotating the cross-section shown in FIG. 36 about a central proximal-distal axis 3699.

[0554] In some embodiments, the proximal connector 3666a connects a removable delivery apparatus (not shown) to the device 3602. In some embodiments, the one or more radiation sources 3604 are connected to the expandable body 3608, e.g., directly by one of the connector(s) 3666a, 3666b (and in an exemplary embodiment, by the proximal connector 3666b) and / or via a holder 3606, where in some embodiments the holder 3606 includes one or more features shown in figures associated with this document and / or described with respect to the holder(s) elsewhere in this document.

[0555] Patent document US9844382 (hereby incorporated by reference in its entirety) shows a device for treating vascular deformities (eg, aneurysms).

[0556] In some embodiments, the exemplary source(s) described in this document (e.g., in the section entitled "Exemplary Radiation Levels" and / or the section entitled "Exemplary Sources and Exemplary Source Mounting") are attached to a structure(s) described in US9844382 (e.g., including one or more of the mounting methods and / or structures described in the section entitled "Exemplary Sources and Exemplary Source Attachments" of this document).

[0557] FIG. 37 is a simplified schematic cross-sectional view of an expandable device 3702 according to some embodiments of the invention.

[0558] In some embodiments, the expandable device 3702 is an elongated structure including a mesh body 3708, where in some embodiments the body 3708, in some embodiments having a tubular structure, is coiled within the aneurysm. In some embodiments, the mesh body 3708 is expandable in one or more regions in a direction perpendicular to the central longitudinal axis of the device. In this case, for example, in some embodiments, upon entering the aneurysm, the expandable regions expand, for example to increase the volume of the aneurysm surrounded by the surface of the device. In some embodiments, one or more portions of the elongated structure include connectors 3766a, 3766b, which in some embodiments house a radiation source and / or are connected to a holder that houses a radiation source. Alternatively or additionally, in some embodiments, one or more radiation sources 3704 are connected to the body 3708 along the length of the body. In embodiments, the radiation source 3704 is optional if a radiation source is connected to one or both of the connectors 3766a, 3766b.

[0559] Additional Example Methods FIG. 39A is a flowchart of a method according to some embodiments of the present invention.

[0560] At 3900, in some embodiments, the compressed device is delivered to a treatment site, such as an aneurysm. In some embodiments, the delivery includes one or more features of step 208 of FIG.

[0561] In some embodiments, the device does not include a radiation source(s). For example, the devices described elsewhere in this document are used without an attached radiation source. In some embodiments, the device does not include a holder for a radiation source, where in some embodiments the holder described elsewhere in this document is absent and / or replaced with an element(s) that provides the mechanical feature(s) described.

[0562] In some embodiments, the device includes one or more features of the device 102 of FIG. 1 without the source 104 and / or the holder 106.

[0563] 4A-4H without the source 404 and / or holder 406. For example, in some embodiments, in device 402 without holder 406, the push wire 422 is attached directly to the body 408, as opposed to being attached to a holder 406 that attaches the push wire 422 to the body 408, for example.

[0564] In some embodiments, the device includes one or more features of device 502 of FIG. 5 without source 504 and / or holder 506.

[0565] In some embodiments, the device includes one or more features of device 602 of FIG. 6 without source 604 and / or holder 606.

[0566] In some embodiments, the device includes one or more features of device 702 of FIG. 7 without source 704 and / or holder 706.

[0567] In some embodiments, the device includes one or more features of device 802 of FIG. 8 without source 804 and / or holder 806.

[0568] In some embodiments, the device includes one or more features of device 902 of FIG. 9 without the source 904 and / or holder 906.

[0569] In some embodiments, the device includes one or more features of device 1002 of FIG. 10 without source 1004 and / or holder 1006.

[0570] 11 , where there is no source disposed within lumen 1146 and / or device 1102 lacks portion(s) 1136 and / or 1134. For example, connection to the push wire is provided by portion(s) that replace portion 1136 and / or portion 1134. For example, in some embodiments, the device has the shape and / or geometry and / or other body characteristic(s) described with respect to body 1108, but has attachment regions that include feature(s) described elsewhere in this document, e.g., with respect to one or more of attachment regions 4011 (FIGS. 40A-40C), 4111 (FIGS. 41A-41B), 4211 (FIGS. 42A-42F), 4311 (FIGS. 43A-43C), 4411 (FIGS. 44A-44B), 4511 (FIGS. 45A-45D), 4611 (FIGS. 46A-46D), 4711 (FIGS. 47A-47C), 4811 (FIGS. 48A-48C), 4911 (FIGS. 49A-49B), 5011 (FIGS. 50A-50B).

[0571] In some embodiments, the device includes one or more features of device 1202 of Figures 12A-12H, eg, without source 1204 (and / or holder 1206).

[0572] In some embodiments, the device includes one or more features of device 1302 of Figures 13A-13C (e.g., having the shape and / or geometry and / or other characteristics of body 1108) without the source and / or holder 1306.

[0573] In some embodiments, the device includes one or more features of device 1402 of Figures 14A-14C (e.g., having the shape and / or geometry and / or other characteristics of body 1408) without the source and / or holder 1406.

[0574] In some embodiments, the device includes one or more features of device 1502 of Figures 15A-15C (e.g., having the shape and / or geometry and / or other characteristics of body 1508) without the source and / or holder 1506.

[0575] In some embodiments, the device includes one or more features of device 1602 of Figures 16A-16B (e.g., having the shape and / or geometry and / or other characteristics of body 1608) without the source 1604 and / or holder 1606.

[0576] In some embodiments, the device includes one or more features of device 1702 of Figures 17A-17B (e.g., having the shape and / or geometry and / or other characteristics of body 1708) without the source and / or holder 1706.

[0577] In some embodiments, the device includes one or more features of device 1802 of FIG. 18 (e.g., having the shape and / or geometry and / or other characteristics of the body of device 1802) without a source and / or holder 1806 (the device body including, for example, base 1816 and / or wall 1810 and / or support base 1884 and / or wall 1886).

[0578] In some embodiments, the device includes one or more features of device 2702 of FIG. 27 (e.g., having the shape and / or geometry and / or other characteristics of body 2708) without source 2704a and / or holder 2706.

[0579] In some embodiments, the device includes one or more features of device 2802 of FIG. 28 (e.g., having the shape and / or geometry and / or other characteristics of body 2808) without having sources 2804a-2804d and / or holder 2806.

[0580] At 3902, in some embodiments, the device is deployed to a treatment site, such as within an aneurysm, for example, where the deployment includes one or more features of step 210 of FIG.

[0581] FIG. 51 is a flowchart of a method according to some embodiments of the present invention.

[0582] At 5100, optionally, a radiation source is attached to the device. For example, the attachment may include one or more features of step 202 of FIG.

[0583] At 5102, in some embodiments, the compressed device is delivered to a treatment area (e.g., an aneurysm). For example, the delivery may include one or more of the features described with respect to step 3900 of FIG.

[0584] In some embodiments, the device is compressed by inserting the device into a tubular structure, such as a crimp tube, for example by threading the device through the crimp tube (e.g., using a push wire) and then drawing the device into the crimp tube, for example, by pulling the push wire of the device.

[0585] At 5104, in some embodiments, the device is deployed within the treatment site (e.g., aneurysm). For example, the deployment may include one or more of the features described with respect to step 3902 of FIG.

[0586] At 5106, optionally, in some embodiments, one or more radiation sources are decoupled from the device and / or coupled to the device.

[0587] For example, in some embodiments, upon deployment, the radiation source(s) are delivered to the treatment area and optionally coupled and / or attached to the deployed device. In some embodiments, after deployment of the device, the portion(s) of the device to house the radiation source(s) are selected based on, for example, location relative to the anatomy of the treatment site. For example, in some embodiments, the deployed radiation source(s) are decoupled, for example, from the device and then removed or repositioned. A potential benefit of coupling and / or decoupling after deployment is the ability to precisely position the source(s) relative to the anatomy of the treatment site.

[0588] In some embodiments, after deployment of the device, the physician decides whether to couple or detach the radiation source(s), e.g., after taking one or more measurements. For example, in some embodiments, flow measurement(s) are collected after positioning the device, and the radiation source is coupled and / or detached based on how the mechanical structure of the expanded device affects blood flow to the aneurysm. For example, if blood flow is sufficiently mechanically reduced, in some embodiments the radiation source is not coupled, and in some embodiments the device does not include any radiation source in situ.

[0589] At 5108, in some embodiments, the device is detached from the delivery apparatus, for example from the push wire, including, for example, one or more features of step 212 of FIG.

[0590] At 5110, in some embodiments, the delivery device (including, for example, the push wire and the delivery catheter) is removed, for example, including one or more features of step 214 of FIG.

[0591] At 5112, optionally, in some embodiments, a period of time is allowed to pass, e.g., a period of time sufficient to determine the therapeutic efficacy of the in situ device, e.g., from one day to six months. In some embodiments, imaging and / or other measurement(s) are performed to determine the effectiveness of the device treatment (e.g., the patient is diagnosed using one or more features of step 200 of FIG. 2). In some embodiments, based on the diagnosis, modification(s) to the device are selected, where in some embodiments the modification(s) include removal and / or addition of radiation source(s).

[0592] At 5114, optionally, in some embodiments, the radioactive source(s) are detached and / or the radioactive source(s) are coupled to the device, e.g., selected based on the diagnosis, in some embodiments, a delivery device is placed at the treatment site and interacts with the device to couple and / or detach one or more radiation sources.

[0593] For example, with reference to Figures 11, 19A-19B, the device includes a container(s) configured to house the radioactive device(s) coupled to the device, and in some embodiments, the container is opened by a delivery device to remove the radioactive source or to insert the radioactive source (in some embodiments, to insert an additional radioactive source).

[0594] In some embodiments, one or more radiation sources are attached to the device, e.g., to a holder for the device and / or to the body of the device. For example, in some embodiments, a radiation source is wrapped (or unwound) around a portion of the device (e.g., a holder) and / or fixed to a portion of the device (e.g., a coil radiation source is pressed (or retracted) against a portion of the device, e.g., a holder).

[0595] Additional Example Expansion Devices FIG. 39B is a simplified cross-sectional schematic diagram of an intravascular device system 3900 according to some embodiments of the present invention.

[0596] In some embodiments, system 3900 includes one or more features of system 100 of FIG. 1 but lacks source 104 of FIG. 1 and / or device 3902 includes one or more features of device 102 of FIG. 1 but lacks source 104 of FIG. 1.

[0597] In some embodiments, the device 3902 includes a second body layer 1363 (also referred to as a "support").

[0598] FIG. 39C is a simplified cross-sectional schematic diagram of an intravascular device system 3901 according to some embodiments of the present invention.

[0599] In some embodiments, system 3901 includes one or more features of system 100 of FIG. 1 but lacks source 104 of FIG. 1 and / or device 3903 includes one or more features of device 102 of FIG. 1 but lacks source 104 of FIG. 1.

[0600] In some embodiments, the device 3904 includes a second body layer 3965 (also referred to as a "support").

[0601] In some embodiments, the device body 3908 is recessed, for example at the base, and the recess 3960 includes one or more features of recess 1360 (FIGS. 13A-13B), and / or recess 1460 (FIGS. 14A-14C), and / or recess 1560 (FIGS. 15A-15C), and / or recess 1788 (FIGS. 17A-17B).

[0602] FIG. 40A is a simplified schematic cross-sectional view of a device 4002 according to some embodiments of the present invention.

[0603] FIG. 40B is a simplified schematic cross-sectional view of a portion of device 4011 according to some embodiments of the present invention.

[0604] In some embodiments, FIG. 40B shows an expanded view of the connection region 4011 of FIG. 40A.

[0605] FIG. 40C is a simplified schematic cross-sectional view of a portion 4011 of a device according to some embodiments of the present invention.

[0606] In some embodiments, FIG. 40C shows a cross-sectional view of portion 4011 taken along line AA of FIG. 40B.

[0607] In some embodiments, device 4002 includes one or more features of device(s) 1202 shown and / or described with respect to Figures 12A-12H, where in some embodiments like numerals refer to corresponding features, e.g., feature 1210 corresponding to feature 4010.

[0608] In some embodiments, the device 4002 includes an expandable body 4008. In some embodiments, the body 4008 has a curved cup shape including a wall region 4010 and a base region 4016.

[0609] In some embodiments, at least a portion of the expandable body 4008 is constructed by using a tubular material (e.g., mesh) where one of the ends of the tubular shape is narrowed and / or closed and / or held together at the connection region 4011. The tubular shape, in some embodiments, has a smaller cross-sectional area at the end of the device at the connection region 4011 than the cross-sectional area at the distal end of the wall 4010. In some embodiments, the tubular shape has a decreasing cross-sectional area proceeding in a direction toward the connection region 4011, for example to form a flattened cup shape with an opening at the connection region 4011.

[0610] In some embodiments, the tubular mesh has a uniform porosity and / or mesh density along the tube. In some embodiments, the tubular mesh is then shaped, e.g., folded and / or shrunk (e.g., attached at attachment regions) to form the body 4008 and / or the support 4040. In some embodiments, the folding and / or shrunk changes the porosity of the device and / or the density of the mesh in one or more portions of the device from the density of the tubular structure from which the device is formed, e.g., the mesh density increases (e.g., decreases in porosity) toward the center of the device, as shown in Figures 41A-41B. In some embodiments, the device is elastically relaxed when in the open configuration, as shown in Figures 40A-40C and / or 41A-41B. In some embodiments, the elastic relaxation in the open shape configuration is created using a tubular Nitinol structure that has been heat treated to have a shape memory in the open configuration. For example, in some embodiments, the tubular mesh is inserted into and / or placed on a mold and then heat treated to shape memory set at least a portion of the shape of the device to the shape of the mold. In some embodiments, the shape of the device is set using a single mold and / or heat treatment. In some embodiments, multiple mold(s) and / or heat treatments are used (e.g., sequentially) to shape the device. In some embodiments, the device 4002 includes one or more supports 4040, 4050, where in some embodiments the supports 4040, 4050 include one or more additional layers of material (e.g., body material) with the layer(s) extending at least over (at least a portion of) a central region of the device (e.g., at least the central 10%, e.g., the center in at least one dimension). Wherein, in some embodiments, the central region of the device is in the connection region 4011.

[0611] In an exemplary embodiment, the supports 4040, 4050 are formed from a tube of the same material (e.g., mesh) as the body 4010. The support portions 4040, 4050 are formed by folding the tube over one or more times, for example, twice as shown in FIG.

[0612] In some embodiments, the device 4002 optionally includes a holder 4006 and / or optionally includes a connector 4066 and / or optionally includes a bonding material 4051.

[0613] In some embodiments, the connection region 4011 (e.g., including one or more of the holder 4006, the connector 4066, and the bonding material) provides one or more of the following (e.g., as described above): connection of the body end 4009, connection of the device 4002 to the delivery apparatus 4022, connection of the device 4002 to the holder 4006, radiopaque markings (e.g., in some embodiments, the connector 4066 and / or the holder 4006 include a radiopaque material), and optionally housing a radiation source(s).

[0614] In some embodiments, of the illustrated element holder 4006, connector 4066, and bonding material 4051, the device 4002 includes only the bonding material, where, for example, the end 4009 and / or delivery apparatus 4022 are attached by bonding and / or welding of 4051 only.

[0615] In some embodiments, connectors 4066 are present along with the bonding material 4051. For example, connectors 4066 provide mechanical support to the connection of ends 4009 and / or radiopaque markings.

[0616] In some embodiments, the device 4002 also includes a holder 4006 .

[0617] Optionally, in some embodiments, the holder 4006 is disconnected from the delivery device 4022 during and / or after deployment of the device. In some embodiments, the holder 4006 is part of the delivery device and in some embodiments is removed from the device 4002 during and / or after deployment of the device.

[0618] In some embodiments, the connection of the body 4008 at the connection region 4011 is made by joining and / or welding another portion to a portion of the end of the body 4008, such as by joining a portion to the end of the body 4008. For example, by joining one of the holder 4006 and the connector 4066 to the body, the other of the holder 4006 and the connector 4066 is not connected (e.g., removable) and / or is not present.

[0619] 40B-40C, in some embodiments, the connection is made by holding the body end 4009 between two other portions (which in some embodiments is an end of a tubular material extending from the support 4040). For example, in some embodiments, the end 4009 is held between the connector 4066 and the holder 4006, and optionally, a bonding material 4051 is disposed between the connector and the holder. In some embodiments, for example, if the material of the body 4008 is porous (e.g., a mesh), the material of the end 4009 is embedded in the bonding material 4051, as shown, for example, in FIG. 40B. In some embodiments, the bonding material 4051 is one of: disposed between the connector 4066 and the body portion 4051, and disposed between the body 4008 and the holder 4006.

[0620] In some embodiments, for example as described elsewhere in this document, the body portion(s) of device 4002 are connected and / or closed at connection region 4011.

[0621] In some embodiments, the holder 4006 (eg, as described elsewhere in this document) holds one or more radiation sources and / or provides a connection to a delivery device and / or a positioning device 4122.

[0622] In some embodiments, the body 4008 is joined to the holder 4006 and / or the connector 4066, for example, by a joining material 4051. In some embodiments, the connector 4066 provides mechanical strength to the connection of the body 4008 materials. Alternatively or additionally, the connector 4066 is a marker, for example comprising a radiopaque material.

[0623] In some embodiments, the connector 4066 is annular (e.g., in some embodiments, the connector 4066 is cylindrical, as shown together in FIGS. 40C, 40B, and 40C). In some embodiments, the bonding material 4051 is continuous in profile around the connector 4066 and / or the holder 4006 (e.g., as shown in FIG. 40C). Alternatively, the connector 4066 and / or the bonding material 4051 form a discontinuous profile, for example, for one or more cross sections in the orientation of FIG. 40C.

[0624] In some embodiments, the bonding material 4051 comprises an adhesive, such as an epoxy, such as a UV cured epoxy. In some embodiments, the bonding material 4051 comprises a weld.

[0625] In some embodiments, the body 4010 is porous, for example comprising a mesh. For example, Figure 40C illustrates the porosity of the body 4010, in some embodiments, where the bonding material 4051 penetrates the pores of the body 4010.

[0626] In some embodiments, the device body 4008 is disconnected from the delivery apparatus (e.g., push wire 4022), e.g., after deployment, where in some embodiments, the disconnecting includes one or more of the features shown in FIG. 23 and / or described with respect to separation zone 2392 of FIG. 23.

[0627] FIG. 41A is an image of a side view of a device 4102 according to some embodiments of the present invention.

[0628] FIG. 41B is an image of device 4102 according to some embodiments of the present invention.

[0629] In some embodiments, device 4102 includes one or more features of device 4002 of FIGS. 40A-40C and / or device 1202 of FIGS. 12A-12F.

[0630] 41A-B show the device body 4180, the support 4140, and the push wire 4122. In some embodiments, the holder 4106 comprises an electrically insulating material (e.g., PEEK). In some embodiments, the push wire 4122 is detached from the device 4102 using an applied electrical stimulus, for example as described with respect to the separation region 2392 of FIG. 23. In some embodiments, the holder proximal portion 4136 extends proximally outward from the body 4108 and optionally, in some embodiments, comprises an electrically and / or thermally insulating material (e.g., PEEK). In an exemplary embodiment, the holder 4106 is formed by covering and / or coating a portion(s) of the push wire 4122 with an electrically insulating material (e.g., PEEK).

[0631] FIG. 42A is a simplified cross-sectional schematic diagram of device 4202 during delivery to treatment area 4253, according to some embodiments of the present invention.

[0632] FIG. 42B is a simplified cross-sectional schematic diagram of device 4202 undergoing deployment in treatment area 4253, according to some embodiments of the present invention.

[0633] FIG. 42C is a simplified cross-sectional schematic diagram of device 4202 deployed in treatment area 4253, according to some embodiments of the present invention.

[0634] In some embodiments, Figures 42A-42F show delivery and deployment of the same device. In some embodiments, device 4202 includes one or more features of device 1202 of Figures 12A-12F, and / or device 4002 of Figures 40A-40C, and / or device 4102 of Figures 41A-41B.

[0635] In some embodiments, the device body 4008 and the support 4240 are formed from a single tubular structure, and in some embodiments, the illustration of the body 4008 using solid lines and the support 4240 using dashed lines shows a portion of the tubular structure that corresponds to the body 4008 and the support 4240 when the device is in the expanded configuration.

[0636] 42A, in some embodiments, the delivery catheter 4256 is positioned to have an exit at the treatment region 4253, e.g., the exit is opposite the aneurysm mouth of the bifurcated aneurysm 4253. FIG. 42A shows the device 4202 in a folded and / or crimped configuration, in some embodiments, where the device 4202 is stretched from an elastically relaxed open configuration to a tubular shape, with the ends of the tubular shape closed at connection regions 4211. In some embodiments, the ends are connected to a push wire 4222. A potential advantage of the crimped configuration shown in FIG. 42A is the low profile (e.g., cross-sectional area perpendicular to the cross-section shown in the figure) of the crimped device, potentially enabling, for example, the use of smaller cross-sectional catheters, navigation of tortuous vasculature, and / or deployment through small cross-sectional vessels. In some embodiments, the folded and / or crimped configuration of the device maintains the foldback of the support 4040, as shown, for example, in FIG. 12E.

[0637] In some embodiments, the device is advanced through the catheter 4256 by a pushing pressure applied to the push wire 4222 .

[0638] 42B, in some embodiments, once the body 4208 of the device 4202 exits the catheter, the device 4202 elastically relaxes the body 4208 to form a curved closure against the aneurysm 4253.

[0639] Now referring to FIG. 42C, in some embodiments, when the device 4202 is fully delivered through the catheter 4256, the support 4240 elastically relaxes and folds back into place within a volume defined by the body 4208 (e.g., by the base and walls of the body).

[0640] 42C , after the device 4202 is deployed, the push wire 4222 is detached from the device 4202, e.g., withdrawn after and / or with the delivery catheter 4256. In some embodiments, the holder 4206 is detached from the device 4202, e.g., withdrawn with the push wire 4222. In some embodiments, the holder 4206 is part of the push wire 4222.

[0641] FIG. 42D is an image of device 4202 deployed in treatment area 4253, according to some embodiments of the present invention.

[0642] In some embodiments, Figure 42D shows an x-ray image of the device 4202 deployed within a bifurcation aneurysm 4253. Shown in Figure 42D are the device body 4208, the support structure 4240, and the markers 4266. In Figure 42D, the delivery apparatus (e.g., including the push wire and / or catheter) has been withdrawn.

[0643] FIG. 42E is a simplified cross-sectional schematic diagram of device 4202 deployed in treatment area 4255, according to some embodiments of the present invention.

[0644] In some embodiments, the treatment area 4255 is a saccular aneurysm. In some embodiments, the delivery and / or deployment of the device 4202 to the saccular aneurysm includes one or more of the features described with respect to the delivery and / or deployment of the device 4602 in Figures 46A-C, such as bending of the delivery catheter.

[0645] FIG. 42F is an image of device 4202 deployed in treatment area 4255, according to some embodiments of the present invention.

[0646] In some embodiments, Figure 42F shows an x-ray image of the device 4202 deployed within a saccular aneurysm 4255. Shown in Figure 42F are the device body 4208, the support 4240, and the markers 4266. In Figure 42F, the delivery apparatus (e.g., including the push wire and / or catheter) has been withdrawn.

[0647] FIG. 43A is a simplified schematic cross-sectional view of a device 4302 according to some embodiments of the present invention.

[0648] FIG. 43B is a simplified schematic cross-sectional view of a portion of device 4311 according to some embodiments of the present invention.

[0649] In some embodiments, FIG. 43B shows a close-up view of connection region 4311 of FIG. 43A.

[0650] FIG. 43C is a simplified schematic cross-sectional view of a portion 4311 of a device according to some embodiments of the present invention.

[0651] In some embodiments, FIG. 43C shows a cross-sectional view of portion 4311 taken along line BB in FIG. 43B or line CC in FIG. 43B.

[0652] 43A, in some embodiments, device 4302 includes a body 4308 whose shape includes one or more features of body 4208 of Figures 42A-42F (and / or body 1208 of Figures 12A-12H). In some embodiments, device 4302 includes a second support layer 4363 (also referred to herein as a "support").

[0653] In some embodiments, support 4363 follows the shape of body 4308, for example, where both body 4308 and support 4363 have a cup shape, or a flat cup shape, and / or walls and a base. Here, in some embodiments, support 4363 is nested within base 4308, for example, occupying a volume indicated by body 4308. In some embodiments, support 4363 follows the shape of body 4308, except for region 4371 of support 4363 adjacent connection region 4311. Here, in some embodiments, within region 4371, support 4373 is separated from body 4308 by a distance that corresponds, for example, to the height of element(s) of connection region 4311. For example, in some embodiments, the length of region 4371 is at least about the same length as height 4373, or is 0.5-4 times, or 1-3 times, or 1-2 times, or smaller, or larger, or intermediate multiples or ranges. In some embodiments, the length 4371 is between 1 and 20%, or between 5 and 20%, or between 5 and 10% of the width 4307 of the device 4302 (in one or more dimensions).

[0654] In some embodiments, a portion (or portions) of the support 4363 that conforms to the shape of the body 4308 has a separation 4375 between the contour of the body 4308 and the contour of the support 4363 that is up to 0.1-20%, or 0.5-10%, or 1-10% of the device width 4307 and / or device height 4358.

[0655] In some embodiments, the material of the body 4308 enters the connection region in a first direction and the material of the support 4373 enters the connection region in a second direction, where in some embodiments the directions are generally opposite, e.g., about 180 degrees from each other.

[0656] In some embodiments, the separation between the support 4373 and the base 4308 is the separation of the rigid element(s) of the connection region at least in region 4371 and / or the opposing directions of interaction of the support 4373 and the body 4308 with the connection region 4311 contribute to a thinner device 4302 when in a folded or crimped configuration, as shown, for example, by device 4502 in FIG. 45A.

[0657] In some embodiments, the body 4308 is closed at the connection region. In some embodiments, the support 4363 is closed at the connection region. For example, the body 4308 and / or the support 4363 are each constructed from sections of tubing that are connected and / or closed at the connection region 4311.

[0658] In some embodiments, closure of the body 4308 and the support 4363 is provided by separate connectors 4366, 4367 and joining material portions 4351, 4355.

[0659] Now referring to FIG. 43B, in some embodiments, the body 4308 is closed by bonding material 4351 and / or connector 4366 and / or holder 4306, with various options described for connecting the body 4008 by bonding material 4051 and / or connector 4066 and / or holder 4006 in FIGS. 40A-40C.

[0660] In some embodiments, the support 4363 is closed by bonding material 4353 and / or connector 4367 and / or holder 4306, with various options as described for connecting the body 4008 by bonding material 4051 and / or connector 4066 and / or holder 4006 in Figures 40A-40C.

[0661] In some embodiments, the support 4363 and the body 4308 are connected by connecting both parts to the holder 4306. Alternatively or additionally, in some embodiments, the support 4363 and the body 4308 are connected by connecting connectors 4366, 4367, for example by a welding material 4355. Alternatively or additionally, in some embodiments, the support 4363 and the body 4308 are connected by a joining material 4353, 4351 that extends to connect the parts (as shown, for example, by joining material 5051 in FIGS. 50A-50B). Alternatively or additionally, in some embodiments, the functionality of the connectors 4366, 4377 is provided by a single connector (as shown, for example, by connector 5066 in FIGS. 50A-50B).

[0662] In some embodiments, the connector(s) and / or bonding material region(s) form a closed shape (eg, a ring) around a central axis 4399 of the device 4302, as shown, for example, in FIG. 43C.

[0663] Additional embodiments for attachment of the body 4308 and the support 4363 are shown in Figures 47A-47C, 48A-48C, and 49A-49B.

[0664] In some embodiments, the body 4308 and the support 4363 are provided connected, for example constructed by a single folded tubular structure (e.g., a tubular mesh), as shown in Figures 50A-50B, in some embodiments.

[0665] In some embodiments, the body 4308, when coupled to the body connection region 4311, includes a recess 4360 in a central region of the body, where the recess 4360 includes one or more features of the recess(es) described elsewhere in this document.

[0666] FIG. 44A is an image of a side view of a device 4402 according to some embodiments of the present invention.

[0667] FIG. 44B is an image of device 4102 according to some embodiments of the present invention.

[0668] In some embodiments, Figures 44A-44B show the device 4302 of Figures 43A-43C.

[0669] 44A-B show body 4408, support 4463, central region 4457 of support 4463, push wire 4422, connector 4466, and holder 4406. FIGS. 44A-B show wires protruding from body 4408 in an area of ​​body 4408 adjacent connection region 4411. These wires are connected (e.g., laser welded) to body 4408 in some embodiments. For example, in some embodiments, the protruding wires are connected (e.g., by welding) to the junction where two wires of the mesh intersect.

[0670] In some embodiments, the holder 4406 comprises an electrically insulating material (e.g., PEEK), and in some embodiments, the push wire 4422 is detached from the device 4402 using electrical stimulation, e.g., electrolytic isolation, e.g., electrothermal isolation (e.g., as described elsewhere in this document).

[0671] FIG. 45A is a simplified cross-sectional schematic diagram of a device 4502 during delivery to a treatment area 4553, according to some embodiments of the present invention.

[0672] FIG. 45B is a simplified cross-sectional schematic diagram of device 4502 undergoing deployment in treatment area 4553, according to some embodiments of the present invention.

[0673] FIG. 45C is a simplified cross-sectional schematic diagram of device 4502 deployed in treatment area 4553, according to some embodiments of the present invention.

[0674] FIG. 45D is a simplified cross-sectional schematic diagram of device 4502 deployed in treatment area 4553, according to some embodiments of the present invention.

[0675] FIG. 45E is an image of device 4502 deployed in treatment area 4553, according to some embodiments of the present invention.

[0676] In some embodiments, Figures 45A-45E show delivery and deployment of the same device, hi some embodiments, device 4502 includes one or more features of device 4302 of Figures 43A-43C and / or device 4402 of Figures 44A-44B.

[0677] 45A, in some embodiments, the delivery catheter 4556 is positioned to have a catheter exit at the treatment region 4553, e.g., the exit is opposite the mouth of the bifurcated aneurysm 4553. FIG. 45A shows the device 4502 in a folded and / or crimped configuration in some embodiments. In some embodiments, the device 4502 is folded by folding both the body 4508 and the support 4363 back in the same direction toward the central axis of the device 4502 (e.g., central axis 4399 shown in FIG. 43A). In some embodiments, the shape of the support 4563 in the central region of the device 4502 allows for a smaller cross-sectional profile of the device. For example, in some embodiments, as the catheter 4556 narrows relative to the device 4502, the body 4508 is forced into contact with elements of the connection region 4511, and the narrowing is limited by the size of the connection region 4511 and the thickness of the material of the body 4508. However, in some embodiments, when supports 4563 are curved away from connection region 4511 , the profile of device 4508 is not further limited by the thickness of the material of supports 4563 .

[0678] In some embodiments, the device is advanced through the catheter 4556 by a pushing pressure applied to the push wire 4522 .

[0679] Now referring to FIG. 45B, in some embodiments, when the body 4508 (and optionally the support 4556) of the device 4502 exits the catheter 4556, the body 4508 (and optionally the support 4556) elastically relaxes to form a curved closure (optionally a double-layer closure with the support 4556) against the aneurysm 4553.

[0680] 45C now shows the device resiliently relaxed within the aneurysm 4553 in some embodiments. In some embodiments, after the device 4502 is deployed, the push wire 4522 is detached from the device 4502, e.g., withdrawn after and / or with the delivery catheter 4556, leaving the device 4502 in place, e.g., as shown in FIG. 45D. In some embodiments, the holder 4506 is detached from the device 4502, e.g., withdrawn with the push wire 4522. In some embodiments, the holder 4506 is part of the push wire 4522.

[0681] FIG. 45E is an image of device 4502 deployed in treatment area 4553, according to some embodiments of the present invention.

[0682] In some embodiments, Figure 45E shows an x-ray image of the device 4502 deployed within a bifurcation aneurysm 4553. Shown in Figure 45E is the device body 4508, and markers 4566. In Figure 42E, the delivery apparatus (e.g., including the push wire and / or catheter) has been withdrawn.

[0683] FIG. 46A is a simplified cross-sectional schematic diagram of device 4602 during delivery to treatment area 4655, according to some embodiments of the present invention.

[0684] FIG. 46B is a simplified cross-sectional schematic diagram of device 4602 undergoing deployment in treatment area 4655, according to some embodiments of the present invention.

[0685] FIG. 46C is a simplified cross-sectional schematic diagram of device 4602 deployed in treatment area 4655, according to some embodiments of the present invention.

[0686] FIG. 46D is an image of device 4602 deployed in treatment area 4655, according to some embodiments of the present invention.

[0687] In some embodiments, device 4602 includes one or more features of device 4302 of FIGS. 43A-43C, and / or device 4403 of FIGS. 44A-44B, and / or device 4502 of FIGS. 45A-45E.

[0688] In some embodiments, the device 4602 is delivered to the saccular aneurysm 4655 (and / or one or more other devices described herein) by bending the delivery catheter 4656 (e.g., the distal end of the delivery catheter) such that the outlet of the delivery catheter 4656 is directed toward the mouth of the aneurysm 4655. Here, in some embodiments, the distal portion of the catheter 4656 is controllably bent. For example, in some embodiments, a Bandit™ microcatheter is used. For example, in some embodiments, selective tension applied to an elongated element coupled to the distal end of the catheter is used to bend the catheter 4656.

[0689] FIG. 52 is an image of a portion of a device 5208 according to some embodiments of the present invention.

[0690] In some embodiments, the depicted portions are edge regions of the device (eg, as defined below).

[0691] In some embodiments, the wire(s) of the mesh structure(s) are connected, e.g., to the distal end of the structure(s) of the device body, e.g., to potentially prevent delamination of the mesh. For example, in some embodiments, the distal end of one or more tubular structures of one or more devices described herein has connections between the wires of the mesh, e.g., the open distal end 4391 of the body 4308 of the device in FIG. 43A and / or the open distal end of the support 4393. For example, the open distal end 4091 of the body 4008 of the device in FIGS. 40A-40C.

[0692] In some embodiments, the distal wire(s) of the device mesh connect portion(s) of the mesh to one another (e.g., by welding, e.g., laser welding, e.g., spot welding), the connection potentially preventing delamination of the mesh.

[0693] In some embodiments, the distal end(s) 5299 of the wires are connected, such as when the distal ends of two wires are connected at a distal crossover point of the wires.

[0694] In some embodiments, each or most, e.g., greater than 90%, of the distal ends of the wires of the device mesh are connected, in some embodiments, only a portion of the distal ends are connected, e.g., 20-90%, or a smaller, greater, or intermediate percentage or range.

[0695] In some embodiments, a portion of the intersection point(s) proximal to the distal end is connected.

[0696] In some embodiments, the wire interconnections of the mesh are made to a distal region of the device mesh, e.g., the interconnections are within the distal 0.1-3 mm, or 0.1-1 mm, or smaller, or larger, or intermediate portions or ranges of the mesh, e.g., as measured from the distal end of the mesh.

[0697] In some embodiments, circumferential portions of the mesh body, for example portions requiring radial reinforcement, are interconnected.

[0698] A potential advantage of increasing the connections between the wires of the mesh is a reduced likelihood of delamination and / or increased mechanical strength of the device in the regions of connection, e.g., increased expansive force (e.g., radial expansive force) of the device against the wall of the aneurysm, e.g., increased elastic expansive force of the device, e.g., resistance to crushing (e.g., radial force).

[0699] A potential drawback of having fewer connections between the wires of the mesh is that it may prevent the wires from moving relative to one another, for example, during expansion and / or contraction of the device.

[0700] FIG. 54 is an image of a portion of a device 5408 according to some embodiments of the present invention.

[0701] In some embodiments, the depicted portions are edge regions of the device (eg, as defined below).

[0702] In some embodiments, one or more ends (and / or end regions) of one or more wires of the device mesh 5408 are blunt. A potential benefit is that the wires are less likely to damage tissue walls, such as penetration of the wire(s) into the wall of the aneurysm in which the device is located, e.g., have a rounded shape and / or a larger cross section in one or more directions than the proximal portion(s) of the wire.

[0703] For example, in the exemplary embodiment shown in FIG. 54, the end(s) of the wire 5497 are welded, for example by laser welding and / or spot welding, to change the shape of the tip 5497 of the wire end.

[0704] 55A-55D are simplified schematic diagrams of device portions 5508a-5508d according to some embodiments of the present invention.

[0705] In some embodiments, the depicted portions are edge regions of the device (eg, as defined below).

[0706] Referring now to FIG. 55A, in some embodiments, selected tips 5597 (eg, fewer than all of the tips) of mesh 5508a are blunted (eg, by welding).

[0707] Referring now to FIG. 55B, in some embodiments, tip 5597 is blunted and a wire connection 5599 is made (eg, a connection including one or more of the features described with respect to connection 5299 in FIG. 52).

[0708] 55C, in some embodiments, one or more end regions of the device 5508c are blunted, such as by a coating, such as a dip coating, of the end(s) of the device 5508c.

[0709] Referring now to FIG. 55D, in some embodiments, one or more end regions of the device 5508d are blunted, for example, by covering them with a film and / or thin layer of material 5593 connected to the end of the device 5508d.

[0710] FIG. 53 is a simplified schematic cross-sectional view of a portion 5311 of a device according to some embodiments of the present invention.

[0711] In some embodiments, the device includes one or more features of the device shown in Figures 43A-43C, but with a connection between body 5308 (corresponding to body 4308 in Figures 43A-43C) and support 5363 (corresponding to support 4363 in Figures 43A-43C), as shown in Figure 53.

[0712] In some embodiments, the proximal end of the tubular structure forming the body 4308 and the proximal end of the tubular structure forming the support 4363 are both connected and enter the proximal end of the lumen of the connector 5366, where connection options include, for example, only bonding material 5351, only connector 5366, or both bonding material and connector, as described with respect to Figures 43A-C.

[0713] In some embodiments, a same-direction connection between the body 5308 and the support 5363 allows the body and support to be in close proximity at the connection area, potentially increasing blockage of blood flow through the layers at the connection area.

[0714] In some embodiments, a free end of a portion of the device comprises an end of a mesh filament where the end is not collected by a connector, where in some embodiments the contour shape of the free end is not modified by one or more elements. In some embodiments, a plurality of ends (or 5 or less, or 10 or less, or 20 or less, or 50 or less wire ends and / or end regions) and / or end region(s) are not bent towards each other. In some embodiments, the free end portion of the device is not folded back over and / or into itself.

[0715] Exemplary Connection Region Embodiments In some embodiments, Figures 47A-47C, 48A-48C, 49A-49B, and 50A-50B show embodiments of connection regions 4711, 4811, 4911, 5011, respectively, suitable for use with body 4308 and / or support 4363 of device 4302 of Figures 43A-43C (e.g., to replace component(s) of connection region 431 of Figures 43A-43C).

[0716] FIG. 47A is a simplified schematic cross-sectional view of a portion 4711 of a device according to some embodiments of the present invention.

[0717] FIG. 47B is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention.

[0718] In some embodiments, FIG. 47B shows a cross-sectional view of portion 4711 taken along line DD in FIG. 47A.

[0719] FIG. 47C is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention.

[0720] In some embodiments, FIG. 47C shows a cross-sectional view of portion 4711 taken along line EE of FIG. 47A.

[0721] In some embodiments, the body 4708 is attached to the holder 4706 by a bonding material 4753. In some embodiments, the support 4763 is attached to the holder 4706 by a bonding material 4751. In some embodiments, the connector 4766 is attached by a bonding material 4751. In some embodiments, the adhesive regions 4751, 4753 are attached to one another by a weld 4755.

[0722] 47B-47C, in some embodiments, one or more of the connector 4766, the bonding material 4751, and the bonding material 4753 have a closed shape (eg, an annular shape) around the holder 4706.

[0723] FIG. 48A is a simplified schematic cross-sectional view of a portion 4811 of a device according to some embodiments of the present invention.

[0724] FIG. 48B is a simplified schematic cross-sectional view of a portion of device 4811 according to some embodiments of the present invention.

[0725] In some embodiments, FIG. 48B shows a cross-sectional view of portion 4811 taken along line FF of FIG. 48A.

[0726] FIG. 48C is a simplified schematic cross-sectional view of a portion 4811 of a device according to some embodiments of the present invention.

[0727] In some embodiments, FIG. 48C shows a cross-sectional view of portion 4811 taken along line GG in FIG. 48A.

[0728] 48A , in some embodiments, the body 4808 is attached between the connectors 4866, 4867, for example by a weld 4855. In some embodiments, the body 4808 then bends outwardly from the connection region 4811 element(s) and / or away from the support 4863. In some embodiments, one or more of the connectors 4866, 4867 are attached to the holder 4806 by a bonding material 4851, 4553, respectively.

[0729] 48B-C, in some embodiments, one or more of connector 4866, connector 4867, joining material 4851, and joining material 4853 have a closed shape (e.g., annular shape) around holder 4806. In some embodiments, weld 4855 has a closed shape around holder 4806 (but in some embodiments is not in contact with holder 4806), e.g., annular shape.

[0730] FIG. 49A is a simplified schematic cross-sectional view of a portion 4911 of a device according to some embodiments of the present invention.

[0731] FIG. 49B is a simplified schematic cross-sectional view of a portion of device 4911 according to some embodiments of the present invention.

[0732] In some embodiments, FIG. 49B shows a cross-sectional view of portion 4911 taken along line HH and / or line II of FIG. 49A.

[0733] 49A shows an embodiment including a single connector 4966 connecting both the body 4908 and the support 4963. In some embodiments, a bonding material 4951 attaches the connector 4966 to the body 4908 and / or the holder 4906. In some embodiments, a bonding material 4953 attaches the connector 4966 to the support 4963 and / or the holder 4906.

[0734] With reference to FIG. 49B, in some embodiments, one or more of the connector 4966, the bonding material 4951, and the bonding material 4953 have a closed shape (eg, annular shape) around the holder 4906.

[0735] FIG. 50A is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention.

[0736] FIG. 50B is a simplified schematic cross-sectional view of a portion of a device according to some embodiments of the present invention.

[0737] In some embodiments, FIG. 50B shows a cross-sectional view of portion 5011 taken along line JJ in FIG. 50A.

[0738] In some embodiments, the body 5008 and the support 5063 are formed by a single section of tubular material that is folded back around the connection region 5011. In some embodiments, a single connector 5066 and / or region of joining material 5051 attaches the body 5088 and the support 5063 and / or attaches the body and support to the holder 5006.

[0739] With reference to FIG. 50B, in some embodiments, the connector 5066 and one or more of the bonding material 5051 have a closed shape (eg, annular shape) around the holder 4906.

[0740] Overview It is anticipated that many devices related to the treatment of endovascular abnormalities and / or aneurysms will be developed during the life of the patent from the filing of this application until its expiration, and it is intended that the scope of the term endovascular device includes, a priori, all such new technologies.

[0741] As used herein, the term "about" refers to ±20%.

[0742] The terms "comprises," "comprising," "includes," "including," "having," and their conjugations mean "including but not limited to."

[0743] The term "consisting of" means "including and limited to."

[0744] The term "consisting essentially of" means that a composition, method, or structure may include additional ingredients, steps, and / or components, but only if the additional ingredients, steps, and / or components do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0745] As used herein, the singular forms "a," "an," and "the" include plural referents unless the context clearly indicates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0746] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to have specifically disclosed all possible subranges as well as individual numerical values ​​within that range. For example, description of a range such as "1-6" should be considered to have specifically disclosed subranges such as "1-3", "1-4", "1-5", "2-4", "2-6", "3-6", and individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0747] Whenever a numerical range is given herein, it is meant to include any recited numbers (fractional or integer) within the given range. The phrases "ranging / ranges between" a first designator number and a second designator number, and the phrases "ranging / ranges from" a first designator number "to" a second designator number, are used interchangeably herein and are meant to include the first designator number and the second designator number, and all fractional and integer numbers therebetween.

[0748] As used herein, the term "method" refers to manners, means, techniques, and procedures for accomplishing a given task, including, but not limited to, methods known by or readily developed from known manners, means, techniques, and procedures by practitioners of the chemical, pharmacological, biological, biochemical, and medical arts.

[0749] As used herein, the term "treating" includes negating, substantially inhibiting, slowing, or reversing the progression of a condition, substantially ameliorating the clinical or cosmetic symptoms of a condition, or substantially preventing the appearance of clinical or cosmetic symptoms of a condition.

[0750] It will be appreciated that certain features of the invention that are described for clarity in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, various features of the invention that are described for brevity in the context of a single embodiment may also be provided separately or in any suitable subcombination or as preferred in any other described embodiment of the invention. Certain features described in the context of various embodiments should not be regarded as essential features of those embodiments, unless the embodiment cannot function without those elements.

[0751] While the present invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.

[0752] It is the intention of the applicants (applicants) that all publications, patents, and patent applications mentioned herein are incorporated herein by reference in their entirety, as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Section headings, if used, should not be construed as necessarily limiting. Additionally, any priority document(s) of this application are hereby incorporated herein by reference in their entirety.

Claims

1. 1. An intravascular device comprising: an expandable body having an expanded configuration and a contracted configuration, the expandable body in the expanded configuration having a convex hemispherical curved shape with a continuously arcuate cross-section; a support providing a bilayer on at least a portion of the expandable body; A connector, The intravascular device, wherein the connector is attached to the expandable body and the support and is recessed within the convex hemispherical curved shape.

2. A device as described in claim 1, wherein the support and distal portions of the expandable body are not connected, and / or the support and the expandable body are connected only at a connection region.

3. The device of claim 2 , wherein the support and the expandable body are connected by the connector.

4. The device of claim 1 or 2, wherein the expandable body is formed by a tubular structure closed at its proximal end by the connector.

5. The device of any one of claims 1 to 4, comprising a radiation source coupled to the expandable body.

6. The device of any one of claims 2 to 5, wherein one or both of the expandable body and the support comprise a mesh.

7. The device of claim 6 , wherein the mesh fiber tips at the ends of one or more portions of the device are blunted.

8. 8. The device of claim 6 or 7, wherein at least some of the mesh fibers are interconnected at a distal end of one or more portions of the device.

9. the expandable body is coupled to the connector from a proximal end of the connector; The device of any one of claims 2 to 8, wherein the support is coupled to the connector from a distal end of the connector.

10. The device of any one of claims 2 to 8, wherein the expandable body and the support are formed by a single tubular structure that is folded back to provide the expandable body and the support.

11. The device of any one of claims 1 to 9, wherein the expandable body, in the expanded configuration, has sufficient elasticity to resist collapse within an aneurysm.

12. The device of any one of claims 1 to 10, wherein the expandable body includes a support portion that reinforces a portion of the continuous arcuate cross-section.

13. The device of claim 12 , wherein the support includes at least a portion recessed within a volume defined by the continuous arcuate cross-section.

14. 14. The device of claim 12 or 13, wherein the support includes at least a portion that extends around the continuous arcuate cross-section.

15. A device according to any one of claims 12 to 14, wherein the support extends from a distal end of the continuous arcuate cross-section.

16. The device of any one of claims 1 to 14, wherein at least a portion of the expandable body is sufficiently flexible to at least partially conform to the interior shape of an aneurysm.

17. The device of any one of claims 1 to 16, wherein the expandable body is elastically expandable to the expanded configuration.

18. A device described in any one of claims 1 to 17, wherein the connector comprises a radiopaque material.

19. The device of claim 1, further comprising a mechanical release configured to remove the push wire from the connector.

20. A device described in any one of claims 1 to 19, wherein the porosity of the intravascular device is 30 to 80%.

21. A device described in any one of claims 1 to 20, wherein the expandable body and the support each include 72 to 288 wires.

22. 1. An intravascular device comprising: an expandable body including two layers and having an expanded configuration and a contracted configuration, wherein when the expandable body is in the expanded configuration, each of the two layers has a convex curved shape including a wall extending from a base; a support providing a bilayer on at least a portion of the expandable body; a connector connecting the bases of the two layers and connecting to the support; The intravascular device, wherein the intravascular device is configured to expand the expandable body prior to expansion of the support.

23. The intravascular device of claim 22 , wherein the connector is recessed into the convex curved shape at least when the expandable body is in the expanded configuration.

24. 24. The intravascular device of claim 22 or 23, wherein the connector defines a proximal end of the expandable body, and the ends of the walls of one or both of the layers are unconnected and provide an opening to a volume defined within the walls of one or both of the layers.

25. The intravascular device of any one of claims 22 to 24, wherein each of the layers of the expandable body is formed by a tubular structure closed at a proximal end by the connector.

26. The intravascular device of any one of claims 22 to 25, wherein the expandable body is formed by a single tubular structure that is folded back to form the base, the folding nesting one portion of the tubular structure within another portion of the tubular structure.

27. The device of any one of claims 22 to 26, wherein the expandable body is constructed from mesh.

28. 28. The device of claim 27, wherein the mesh ends are blunted.

29. 30. The device of claim 27 or 28, wherein at least a portion of the mesh fibers are interconnected at end regions of the expandable body.

30. 30. The device of any one of claims 22-29, comprising a top at least partially enclosing a volume enclosed by the wall, the base being disposed at a proximal end of the expandable body, the wall extending distally from the base, and the top being disposed at a distal portion of the wall.

31. 1. An intravascular device comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body having a convexly curved shape in the expanded configuration, the expandable body comprising: A proximal end; A distal end. a wall connecting the proximal end and the distal end; the expandable body comprising: a connector disposed at the proximal end of the expandable body and connecting the proximal ends of the walls; a support disposed within a volume defined by the wall and providing a bilayer on at least a portion of the expandable body, a support proximal end; a support distal end; a support wall extending from the connector at the support proximal end and extending toward the support distal end; The support comprises: The wall and the support wall are connected by the connector, the connector is attached to the expandable body and recessed within the convex curved shape; a distal end of the wall is unconnected and provides an opening to the volume; a distal end of the support wall is unconnected and provides an opening to the volume; The intravascular device, wherein the support and a distal portion of the expandable body are not connected, and / or the support and the expandable body are only connected at a connection region.

32. 1. An intravascular device comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A first tubular portion; and a second tubular portion nested within the first tubular portion; at least one connector closing a proximal opening of the first tubular portion and a proximal opening of the second tubular portion at a connection region; The expandable body includes: The intravascular device, wherein the first tubular portion enters the connection region from a first direction and the second tubular portion enters the connection region from a second direction.

33. 33. The device of claim 32, wherein the first tubular portion and the second tubular portion are formed by a single tubular portion that is folded back at the connection region.

34. 1. An intravascular device comprising: An expandable body having an expanded configuration and a contracted configuration, the expandable body comprising: A base and a wall extending from the base; a radiation source connected to the base; The intravascular device comprising the expandable body.

35. 35. The device of claim 34, wherein the dose emanating from outside the expandable body and provided by the radiation source when the expandable body is in the expanded configuration is less than 50 Gy.

36. 36. The device of claim 34 or 35, wherein the radiation source delivers a dose of 10-40 Gy at 0-1 mm from an outer surface of the radiation source.

37. The device of any one of claims 34 to 36, wherein the radiation source delivers radiation at an initial rate of 500 to 1000 mGy / hr.

38. The device of any one of claims 34 to 37, wherein the radiation source is disposed in a central region of the expandable body when the expandable body is in the expanded configuration.

39. The device of any one of claims 34 to 37, wherein the radiation source is attached to the expandable body by a holder, the radiation source being attached to the holder and the holder being attached to the expandable body.

40. 40. The device of claim 39, wherein the radiation source is mounted on the holder.

41. 41. The device of claim 39 or 40, wherein the radiation source is held at least partially within a lumen of the holder.

42. A device according to any one of claims 34 to 41, wherein a portion of the base connected to the radiation source is recessed into the wall.

43. The device of any one of claims 34 to 42, wherein the expandable body includes an opening sized and shaped to allow attachment of the radiation source to the device.

44. 44. The device of claim 43, wherein the opening is an opening in a mesh of material forming at least a portion of the expandable body.

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