INTRAVASCULAR DEVICE

An intravascular device comprising: an expandable body having an expanded configuration and a contracted configuration, said expandable body in said expanded configuration having a convex curved shape having a base and walls; and a connector; wherein said connector is attached to said expandable body and recessed within said convex curved shape.

FIELD AND BACKGROUND OF THE INVENTION

The present invention, in some embodiments thereof, relates to treatment of intravascular abnormalities and, more particularly, but not exclusively, to treatment of aneurysm using an expandable intravascular device.

U.S. Patent Application No. 2011/0144669 discloses “An implant for treating brain aneurysms, especially terminal aneurysms, comprises a neck cover and elongate shaft removably secured to an embolic delivery catheter. As such, the shaft aids in directing and placing the cover at the aneurysm neck, protecting the delivery catheter from adhesion with the embolic material, and securing the cover in place with connection or adhesion of the shaft to the embolic material delivered through the catheter. The implant can be anchored at the aneurysm either by interface and/or adhesion of the shaft or shaft and cover with the resident embolic materials.”

U.S. Patent Application No. 2012/0330341 discloses “Embolic implants, methods of manufacture and delivery are disclosed. The subject implants are especially suitable for use is stent-caged aneurysm treatment.”

U.S. Pat. No. 9,393,022 discloses “Embolic implants, delivery systems and methods of manufacture and delivery are disclosed. The subject implants are deployed in two stages. If sized properly as observed in the first stage, they are deployed to the second stage and detached. If not sized properly in/at the first stage, the implants are designed to be withdrawn and replaced with a more appropriately sized implant or another treatment option selected. Some of the implant configurations may be withdrawn even after the second stage deployment as well.”

SUMMARY OF THE INVENTION

Following is a non-exclusive list including some examples of embodiments of the invention. The invention also includes embodiments which include fewer than all the features in an example and embodiments using features from multiple examples, also if not expressly listed below.

Example 1. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body in said expanded configuration having a convex curved shape having a base and walls; anda connector;wherein said connector is attached to said expandable body and recessed within said convex curved shape.

Example 2. The device according to Example 1, wherein said device comprises a support which provides a double layer to at least a portion of said expandable body.

Example 3. The device according to Example 2, wherein said support and said expandable body are connected by said connector.

Example 4. The device according to any one of Examples 1-2, wherein said expandable body is formed by a tubular structure which is closed at a proximal end by said connector.

Example 5. The device according to any one of Examples 1-4, comprising a radioactive source coupled to expandable body.

Example 6. The device according to any one of Examples 2-5, wherein one or both of said expandable body and said support include mesh.

Example 7. The device according to Example 6, wherein mesh fiber tips of ends of one or more portion of said device are blunted.

Example 8. The device according to any one of Examples 6-7, wherein at least some of mesh fibers are interconnected at a distal end of one or more portion of said device.

Example 9. The device according to any one of Examples 2-8, wherein said expandable body joins said connector from a distal end of said connector;

wherein said support joins said connector from a proximal end of said connector.

Example 10. The device according to any one of Examples 2-8, wherein said expandable body and said support are formed by a single tubular structure, folded to provide said expandable body and said support.

Example 11. The device according to any one of Examples 1-9, wherein said expandable body, in said expanded configuration is sufficiently resilient to resist collapse within an aneurysm.

Example 12. The device according to any one of Examples 1-10, wherein said expandable body includes a support portion reinforcing one or both of a portion of said walls and said base.

Example 13. The device according to Example 12, wherein said support includes at least a portion recessed within a volume formed by said walls.

Example 14. The device according to any one of Examples 12-13, wherein said support includes at least a portion extending around one or both of said walls and said base.

Example 15. The device according to any one of Examples 12-14, wherein said support extends from a distal end of said walls.

Example 16. The device according to any one of Examples 1-14, wherein at least one portion of said expandable body is sufficiently flexible to conform, at least partially, to an internal shape of an aneurysm.

Example 17. The device according to any one of Examples 1-16, wherein said expandable body is elastically expandable to said expanded configuration.

Example 18. An intravascular device comprising:an expandable body including two layers and having an expanded configuration and a contracted configuration, where, when said expandable body is in said expanded configuration each of said two layers has a convex curved shape including walls extending from a base;a connector connecting bases of said two layers.

Example 19. The intravascular device according to Example 18, wherein said connector is recessed within said convex curved shape, at least when said expandable body is in said expanded configuration.

Example 20. The intravascular device according to any one of Examples 18-19, wherein said connector defines a proximal end of said expandable body and wherein ends of said walls of one or both of said layers are not connected, providing an opening to a volume defined within walls of said first or said second layer.

Example 21. The intravascular device according to any one of Examples 18-20, wherein each said layer of said expandable body is formed by a tubular structure which is closed at a proximal end by said connector.

Example 22. The intravascular device according to any one of Examples 18-21, wherein said expandable body is formed by a single tubular structure, folded to form said bases, folding nesting a portion of the tubular structure within another portion of the tubular structure.

Example 23. The device according to any one of Examples 18-22, wherein said expandable body is constructed from mesh.

Example 24. The device according to Example 23, wherein mesh ends are blunted.

Example 25. The device according to any one of Examples 23-24, wherein at least a portion of mesh fibers are interconnected at an end region of said expandable body.

Example 26. The device according to any one of Examples 18-25, comprising a top portion at least partially enclosing a volume enclosed by said walls, where said base is disposed at a proximal end of said expandable body, said walls extend distally from said base and said top is disposed at a distal portion of said walls.

Example 27. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body comprising:a proximal end;a distal end; andwalls connecting proximal and said distal end;a connector disposed at said proximal end of said expandable body and connecting proximal ends of said walls;a support disposed within a volume described by said walls and comprising:a support proximal end;a support distal end; andsupport walls extending from said connector at said support proximal end and extending towards said support distal end;wherein said walls and said support walls are connected by said connector.

Example 28. The device of Example 27, wherein distal ends of said walls are not connected, providing an opening to said volume.

Example 29. The device of Example 28, wherein distal ends of said support walls are not connected, providing an opening to said volume.

Example 30. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body comprising:a first tubular portion;a second tubular portion nested within said first tubular portion;at least one connector closing a proximal opening of said first tubular portion and a proximal opening of said second tubular portion at a connection region; andwherein said first tubular portion enters said connection region from a first direction and said second tubular portion enters said connection region from a second direction.

Example 31. The device according to Example 30, wherein said first and said second tubular portions are formed by a single tubular portion folded at said connection region.

Example 32. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body comprising:a base; andwalls extending from said base; anda radioactive source connected to said base.

Example 33. The device of Example 32, wherein a dose emanating outside said expandable body, and provided by said radioactive source, when said expandable body is in in said expanded configuration, is less than 50 Gy.

Example 34. The device according to any one of Examples 32-33, where said radioactive source irradiates a dose of 10-40 Gy at 0-1 mm from an outer surface of the source.

Example 35. The device according to any one of Examples 32-34, wherein said radioactive source irradiates at an initial rate of 500-1000 mGy/hour.

Example 36. The device according to any one of Examples 32-35, wherein said source, when said expandable body is in said expanded configuration, is positioned in a central region of said expandable body.

Example 37. The device according to any one of Examples 32-35, wherein said source is attached to said expandable body by a holder, where said source is attached to said holder and said holder is attached to said body.

Example 38. The device according to Example 37, wherein said source is mounted onto said holder.

Example 39. The device according to any one of Examples 32-38, wherein said source is at least partially held within a lumen of said holder.

Example 40. The device according to any one of Examples 32-39, wherein a portion of said base connected to said source is recessed within said walls.

Example 41. The device according to any one of Examples 32-40, wherein said expandable body includes an opening sized and shaped to enable attachment of said source to said device.

Example 42. The device according to Example 41, wherein said opening is an opening in material mesh forming at least a portion of said expandable body.

Example 43. A method of treatment of aneurysm comprising:positioning an expandable body within an aneurysm in position to cover an opening of the aneurysm;irradiating said aneurysm using a source connected to said expandable body at radiation levels configured to stimulate formation of thrombi within the aneurysm and growth of tissue across the aneurysm opening.

Example 44. The method according to Example 43, wherein said positioning comprising delivering said expandable body intravascularly, in a contracted configuration.

Example 45. The method according to any one of Examples 43-44, wherein said positioning comprises expanding said expandable body within said aneurysm.

Example 46. The method according to any one of Examples 44-45, wherein said delivering comprises applying pressure to a holder connected to said expandable device.

Example 47. The method according to any one of Examples 43-46, comprising attaching a radioactive source to an expandable device, prior to positioning said device.

Example 48. The method according to Example 47, comprising collapsing said expandable device, prior to positioning said device and after attaching said radioactive source.

Example 49. The method according to any one of Examples 43-48, wherein said irradiating comprises irradiating a region of tissue at an opening of said aneurysm with a dose of 10-40 Gy.

Example 50. The method according to Example 49, wherein said irradiating comprises irradiating tissue outside said aneurysm with a dose of less than 50 Gy.

Example 101. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body comprising:a base; andwalls extending from said base; anda radioactive source connected to said base.

Example 102. The device of example 101, wherein said radioactive source provides a dose of 10-40 Gy to a portion of said expandable body, in said expanded configuration.

Example 103. The device of any one of Examples 101-102 wherein a dose emanating outside said expandable body, and provided by said radioactive source, when said expandable body is in in said expanded configuration, is less than 50 Gy.

Example 104. The device according to any one of Examples 101-103, where said radioactive source irradiates a dose of 10-40 Gy at 0-1 mm from an outer surface of the source.

Example 105. The device according to any one of Examples 101-104, where said radioactive source irradiates a dose of 0.1-50 Gy at 0-1 mm from an outer surface of the source.

Example 106. The device of Examples 101-105, where said radioactive source irradiates a dose of 20-150 Gy at 0-1 mm from an outer surface of the source.

Example 107. The device according to any one of Examples 104-106, wherein said radioactive source irradiates at an initial rate of 500-1000 mGy/hour.

Example 108. The device according to any one of Examples 104-106, wherein said radioactive source irradiates at an initial a rate of 25-500 mGy/hour.

Example 109. The device according to any one of Examples 104-106, wherein said radioactive source irradiates at an initial a rate of 0.1-100 mGy/hour.

Example 110. The device according to any one of Examples 101-109, wherein said expandable body, in said expanded configuration is sufficiently resilient to resist collapse within an aneurysm.

Example 111. The device according to any one of Examples 101-110, wherein said expandable body includes a support portion reinforcing one or both of a portion of said walls and said base.

Example 112. The device according to Example 111, wherein said support includes at least a portion recessed within a volume formed by said walls.

Example 113. The device according to any one of Examples 111-112, wherein said support includes at least a portion extending around one or both of said walls and said base.

Example 114. The device according to any one of Examples 111-113, wherein said support extends from a distal end of said walls.

Example 115. The device according to any one of Examples 111-113, wherein at least one portion of said expandable base is sufficiently flexible to conform, at least partially, to an internal shape of an aneurysm.

Example 116. The device according to any one of Examples 111-115, wherein said expandable body is elastically expandable to said expanded configuration.

Example 117. The device according to any one of Examples 111-116, wherein said source, when said expandable body is in said expanded configuration, is positioned in a central region of said expandable body.

Example 118. The device according to any one of Examples 111-117, wherein said source is attached to said expandable body by a holder, where said source is attached to said holder and said holder is attached to said body.

Example 119. The device according to Example 118, wherein said source is mounted onto said holder.

Example 120. The device according to any one of Examples 111-119, wherein said source is at least partially held within a lumen of said holder.

Example 121. The device according to any one of Examples 118-120, wherein said device includes a push-wire and said push-wire is connected to said holder.

Example 122. The device according to any one of examples 101-121, wherein a portion of said base connected to said source is recessed within said walls.

Example 123. The device according to any one of examples 101-122, wherein said walls are tubular.

Example 124. The device according to any one of examples 101-123, wherein said expandable body is constructed from mesh.

Example 125. The device according to any one of examples 101-124, wherein said expandable body includes an opening sized and shaped to enable attachment of said source to said device.

Example 126. The device according to Example 125, wherein said opening is an opening in material mesh forming at least a portion of said expandable body.

Example 127. The device according to any one of examples 101-126, comprising a top portion at least partially enclosing a volume enclosed by said walls, where said base is disposed at a proximal end of said expandable body, said walls extend distally from said base and said top is disposed at a distal portion of said walls.

Example 128. The device according to any one of examples 101-127, wherein at least a portion of said expandable body includes a double layered mesh.

Example 129. A method of treatment of aneurysm comprising:positioning an expandable body within an aneurysm in position to cover an opening of the aneurysm;irradiating said aneurysm using a source connected to said expandable body at radiation levels configured to stimulate formation of thrombi within the aneurysm and growth of tissue across the aneurysm opening.

Example 130. The method according to Example 129, wherein said positioning comprising delivering said expandable body intravascularly, in a contracted configuration.

Example 131. The method according to any one of examples 129-130, wherein said positioning comprises expanding said expandable body within said aneurysm.

Example 132. The method according to any one of examples 130-131, wherein said delivering comprises applying pressure to a holder connected to said expandable device.

Example 133. The method according to any one of examples 129-132, comprising attaching a radioactive source to an expandable device, prior to positioning said device.

Example 134. The method according to Example 133, comprising collapsing said expandable device, prior to positioning said device and after attaching said radioactive source.

Example 135. The method according to any one of examples 129-134, wherein said irradiating comprises irradiating a region of tissue at an opening of said aneurysm with a dose of 10-40 Gy.

Example 136. The method according to Example 135, wherein said irradiating comprises irradiating tissue outside said aneurysm with a dose of less than 50 Gy.

Example 137. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body in said expanded configuration having a convex curved shape; anda connector;wherein said connector is attached to said expandable body and recessed within said convex curved shape.

Example 138. The device according to Example 137, wherein said device comprises a support which provides a double layer to at least a portion of said expandable body.

Example 139. The device according to Example 138, wherein said support and said expandable body are connected by said connector.

Example 130. The device according to any one of examples 137-139, wherein said expandable body is formed by a tubular structure which is closed at a proximal end by said connector.

Example 131. The device according to Example 140, wherein said device comprises a support which provides a double layer to at least a portion of said expandable body;

wherein said support is formed by a tubular structure which is closed at a proximal end by said connector.

Example 132. The device according to any one of examples 138-141, wherein one or both of said expandable body and said support are include mesh.

Example 133. The device according to any one of examples 138-142, wherein said expandable body joins said connector from a distal end of said connector;

wherein said support joins said connector from a proximal end of said connector.

Example 134. The device according to any one of examples 141-143, wherein said expandable body and said support are formed by a single tubular structure, folded to provide said expandable body and said support.

Example 135. An intravascular device comprising:a connector;an expandable body having an expanded configuration and a contracted configuration, said expandable body comprising:a proximal end;a distal end; andwalls connecting proximal and said distal end, said walls connected at said connector disposed at said proximal end;a support disposed within a volume described by said walls and comprising:a support proximal end;a support distal end; andwallssupport walls extending from said connector at said support proximal end towards said support distal end;wherein said walls and said support walls are connected only by said connector.

Example 136. The device of Example 135, wherein distal ends of said walls are not connected, providing an opening to said volume.

Example 137. The device of Example 136, wherein distal ends of said support walls are not connected, providing an opening to said volume.

Example 138. An intravascular device comprising:an expandable body having an expanded configuration and a contracted configuration, said expandable body comprising:a first tubular portion;a second tubular portion nested within said first tubular portion;at least one connector closing a proximal opening of said first tubular portion and a proximal opening of said second tubular portion at a connection region; andwherein said first tubular portion enters said connection region from a first direction and said second tubular portion enters said connection region from a second direction.

Example 139. The device according to Example 138, wherein said first and said second tubular portions are formed by a single tubular portion folded at said connection region.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

The present invention, in some embodiments thereof, relates to treatment of intravascular abnormalities and, more particularly, but not exclusively, to treatment of aneurysm using an expandable intravascular device.

Overview

A broad aspect of some embodiments of the invention relates to treatment of aneurysm using low level radiation to stimulate formation of thrombi within the aneurysm and/or neointima and/or vascular tissue growth at an opening of the aneurysm, to close the aneurysm. In some embodiments, thrombi formed within the aneurysm are prevented from exiting the aneurysm e.g. mechanically by obstruction of the aneurysm. Optionally, in some embodiments, additionally, blood flow into and/or out of the aneurysm is reduced, for example, by the mechanical obstruction. In some embodiments, closure of the aneurysm is achieved without blood flow (e.g. at peak arterial pressure) into and/or out of the aneurysm being reduced.

In some embodiments, an expandable intravascular device is positioned within the aneurysm and holds one or more radioactive source in a position to expose the aneurysm inner volume and/or aneurysm neck to suitable radiation levels whist holding the source at a distance away from healthy tissue that the radiation levels.

In some embodiments, the device includes an expandable body which has a range of expanded configurations associated with different aneurysm sizes. Where, in some embodiments, the expandable body conforms, at least partially to a size and/or shape of the aneurysm. In some embodiments, the device expandable body has a single relaxed expanded configuration e.g. when not under external forces of tissue and/or a delivery apparatus.

In some embodiments, the expandable device, when positioned inside an aneurysm, exposes tissue at an opening of the aneurysm (the “neck”) to a dose of 1-50 Gy, or 10-40 Gy, or lower or higher or intermediate doses or ranges (and/or doses as described in this section of the 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 lower or higher or intermediate ranges or doses. In some embodiments, the only regions of the device which are exposed to doses of more than 50 Gy (or more 100 Gy, or more than 20 Gy, or lower or higher or intermediate ranges or doses) are central (e.g. as defined elsewhere in this document) region/s of the device which, when the device is within an aneurysm relate only to an inner volume of the aneurysm and/or blood vessel and/or blood and/or thrombi.

In some embodiments, a highly radiative source is used, for example, where dosage at a source surface (or less than 1 mm, or less than 0.5 mm from a source surface) are above 50 Gy, or above 100 Gy, or above 300 Gy, or 300-500 Gy, or lower or higher or intermediate sources or ranges. In some embodiments, a highly radiative source provides, at 0-1 mm from an outer surface of the source, a dose of 100-500 Gy or lower or higher or intermediate ranges or doses. In some embodiments, a highly radiative source is positioned such that and/or shielded such that dosage at the neck of the device and/or at a proximal end of the device, and/or (and/or as described elsewhere in this document) and/or dosage outside the device is less than 50 Gy, or less than 100 Gy, or less than 20 Gy, or lower or higher or intermediate ranges or doses.

In some embodiments, dosage at the aneurysm neck is affected by one or more of:

Properties of the source, including size and/or shape and/or activity of the source.

A position of the source within the aneurysm, with respect to the neck e.g. distance of the source to the neck. Which, in some embodiments, is defined by a position of the source with respect to the expandable body, for the expanded configuration of the device for the particular aneurysm.

Shielding of the neck provided by the expandable body, where the shielding is affected by material properties of wires of the expandable body, and/or density of the mesh of the expandable device which, in some embodiments, is associated with expanded configuration of the device for the particular aneurysm.

Shielding of the neck provided by additional shielding elements of the device defined, for example, by the position and/or material characteristics of the element/s.

In some embodiments, dosage outside the aneurysm is also affected by these factors. For example one or more of:

Properties of the source, including size and/or shape and/or activity of the source.

A position of the source within the aneurysm, with respect to tissue portion/s outside the aneurysm e.g. distance therebetween. Which, in some embodiments, is defined by a position of the source with respect to the expandable body, for the expanded configuration of the device for the particular aneurysm.

Shielding of the tissue outside the aneurysm provided by the expandable body, where the shielding is affected by material properties of wires of the expandable body, and/or density of the mesh of the expandable device which, in some embodiments, is associated with expanded configuration of the device for the particular aneurysm.

Shielding of the tissue outside the aneurysm provided by additional shielding elements of the device defined, for example, by the position and/or material characteristics of the element/s.

In some embodiments, one or more of source property/ies, position within the device, shielding provided by the device, is selected to provide desired dosage at the aneurysm neck and outside the aneurysm. Where, in some embodiments, one or more of shielding and position of the source are selected for different aneurysm sizes. In some embodiments, one or more feature is fixed, and other feature/s are selected to provide the desired doses. For example, in some embodiments, an expandable device structure and/or material characteristics are selected and source and/or additional shielding element/s are then selected (and/or a position within the device thereof) to provide the desired dosages.

In some embodiments, one or more source is an element attached to the expandable device. Alternatively or additionally, in some embodiments, one or more portion of the expandable body (e.g. of the mesh) is itself radioactive. Where, in some embodiments, portion/s of the expandable device are treated (e.g. by one or more of the treatment methods as described elsewhere in this document) to be radioactive source/s e.g. as described within this document.

In some embodiments, material of the expandable device at least partially absorbs radiation emitted by source/s. In some embodiments, for example, at least a portion of the expandable device is positioned at and/or in close proximity (e.g. less than 0.1-1 mm, or less than 0.1-0.5 mm, or lower or higher or intermediate distances or ranges) away from walls of the aneurysm, the expandable body serving to, in some embodiments, protect tissue outside of the aneurysm from radiation emitted by the source. In some embodiments, an inner layer of a double layer device (e.g. including walls and support walls) acts to reduce radiation emitted by the source to a suitable levels for a region between the first layer closer to the source of the double layer and a second layer of the double layer. In some embodiments, a number of layers and/or a density of the expandable body is selected for different portions of the aneurysm, for example, in some embodiments, the source is less screened by the expandable body at a region of a neck of the aneurysm. In some embodiments, connecting region (e.g. line of sight) from the source to a neck region is less obstructed than region/s connecting the source to other portions of the device. Where, in some embodiments, less obstruction includes less layers of mesh (e.g. one layer as opposed to two layers) and/or porosity of the mesh and/or positioning of radiopaque element/s e.g. marker/s and/or connecting ring/s. In some embodiments, shielding provided by the expandable body itself enables use of higher strength sources and/or different type/s of radiation e.g. without (or minimally) damaging healthy tissue and/or tissue external to the aneurysm.

In some embodiments, shielding provided by the body of the device allows a single device to be used in a range of applications. For example, a device with a source disposed within a body of the expandable device. Where, when the expandable body is expanded within a small aneurysm has higher shielding properties (e.g. associated with denser packing of the mesh) protecting tissue outside the aneurysm and the same device, in some embodiments, is used for a larger aneurysm, the source being disposed further away from tissue outside of the aneurysm balancing reduced screening by the expanded less dense mesh.

In some embodiments, the expandable intravascular device covers, at least partially, and, in some embodiments, fully, an opening of the aneurysm. For example, with a mesh where, in some embodiments, a mesh pore size is selected to prevent outflow of thrombi over a certain size from the aneurysm.

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

In some embodiments, the aneurysm is a large or giant aneurysm with a maximal and/or average dimension of 10-25 mm or lower or higher or intermediate dimensions or ranges, with, for example, dome to neck ratio of 0.1-3, or lower or higher or intermediate ranges or ratios.

In some embodiments, the aneurysm sac and/or aneurysm neck are exposed to low doses and/or low dose rates of ionizing irradiation, for example, as described later in this document.

An aspect of some embodiments of the invention relates to an intravascular device including an expandable body having walls and a base, with at least one radioactive source connected to the body.

In some embodiments, the expandable body is provided separately to the radioactive source/s, for example, the radioactive source being affixed to the expandable body prior to positioning of the device intravascularly. Potential benefits being decoupling of shelf life of the source and expandable body and/or the need to store only the sources in shielded containers.

In some embodiments, the expandable intravascular device is delivered to an aneurysm and expanded within a volume of the aneurysm, positioning the radioactive source within the aneurysm.

In some embodiments, once the device is expanded within the aneurysm, the base covers an opening of the aneurysm. For example, in some embodiments, the base and/or walls of the device, in an expanded configuration, are sized and/or shaped to cover the aneurysm.

In some embodiments, a device expanded configuration is over-sized, in one or more dimension, with respect to the aneurysm. A potential benefit being that force of the device on the aneurysm and/or resulting friction and/or close fitting of the device to the aneurysm prevents movement of the device, once expanded. A potential benefit of force and/or friction between the device and aneurysm is wounding and/or irritation to the aneurysm which, in some embodiments, increase a rate of healing and/or treatment. In some embodiments, over-sizing is in one or more direction perpendicular to a plane of the aneurysm opening, and/or in an aneurysm opening to dome direction, which direction designations are herein termed, with respect to the device, a proximal-distal direction and/or a length direction of the expandable device. Additionally, or alternatively, in some embodiments, over-sizing is in one or more direction parallel to a plane of the aneurysm volume and/or perpendicular to the proximal-distal and/or parallel to a width and/or depth direction of the device.

In some embodiments, once the device is expanded within the aneurysm, a distal portion of the device adjacent to and/or in contact with aneurysm walls acts to hold the device in position covering the opening of the aneurysm. For example, where contact of the distal portion of the device (e.g. with aneurysm dome), in some embodiments, is arranged by selection of the device to be over-sized with respect to dimension/s of the aneurysm e.g. in an aneurysm neck to dome direction. In some embodiments, the device is configured, for example, a length of the device extending distally from the base is configured to dispose a distal portion of the device at walls of the aneurysm. Where, in some embodiments, the device is elastically expandable in a proximal-distal direction and a relaxed length of the device is larger than a length of the aneurysm e.g. distance from the aneurysm opening to facing inner walls of the aneurysm.

In some embodiments, the expandable body, when at least partially expanded and positioned within an aneurysm, is sufficiently resistant to forces of tissue 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 e.g. under tissue forces of the aneurysm and/or surrounding tissue. In some embodiments, thrombi formed within the aneurysm prevent collapse of the aneurysm and/or of the expandable body. A potential benefit being reduced likelihood of dislodgement of the device from the aneurysm and/or the aneurysm collapsing leaving a remnant aneurysm neck. In some embodiments, the base and/or walls of the expandable body resist collapse of the aneurysm onto the source. A potential benefit being that healthy tissue surrounding the aneurysm is not irradiated at the radiation levels selected for treatment of the aneurysm.

In some embodiments, one or more portion of the expandable body is sufficiently flexible that the expandable body conforms, at least partially, to a shape of the aneurysm. For example, in some embodiments, portion/s of the expandable body walls (e.g. distal portion/s) of the walls conform, at least partially, to a shape of the aneurysm. A potential benefit being reduced likelihood of the device dislodging from position within the aneurysms.

In some embodiments, the expandable body of the device is self-expanding. For example, elastically self-expanding upon exiting (e.g. being pushed out of) a delivery catheter. In some embodiments, the elastic expanding force of the expandable body is sufficient to resist collapse of the expandable body, potentially reducing the chance of dislodgement of the device from the aneurysm lumen.

In some embodiments, the expandable body is not self-expanding or is only partially self-expanding. In some embodiments, for example, the expandable is balloon expanded e.g. by inflating a balloon positioned within the expandable body.

In some embodiments, the source is connected to the expandable body such that the source when the expandable body is in a relaxed expanded configuration (not under externally applied force/s) is positioned at a central region of the expandable body, in one or more direction. In some embodiments, the source is connected to the expandable body such that the source, once the expandable body is positioned within the aneurysm, is positioned in a central region of the aneurysm. For example, in some embodiments, the source is connected to the expandable body such that the source when the expandable body is deployed within an aneurysm (optionally at least partially conforming to the aneurysm shape) is positioned at a central region of the expandable body, in one or more direction.

In some embodiments, a center of the source is positioned within a central 5-80%, or 5-50%, or 5-20%, or lower or higher or intermediate percentages or ranges of the device volume. In some embodiments, the source is positioned within a central region of the expandable structure in one or more direction. For example, in some embodiments, the source (e.g. a center of a cross section of the source taken parallel to the base) is positioned centrally with respect to a base of the expandable device e.g. within a central 5-80%, or 5-50%, or 5-20%, or lower or higher or intermediate percentages or ranges of the base. For example, in some embodiments, the source (e.g. a center of a cross section of the source taken parallel to the walls) is positioned centrally with respect to walls of the expandable device e.g. within a central 5-80%, or 5-50%, or 5-20%, or lower or higher or intermediate percentages or ranges of the walls.

In an exemplary embodiment, the source is connected to a holder which is attached to the expandable body. In some embodiments, the source is connected to the holder, shortly prior to use of the device in treatment. A potential benefit being de-coupling of the source expiry-date and/or lifetime from that of the expandable body.

In some embodiments, the holder also provides mechanical support to the expandable body. Where, in some embodiments, the holder is used in delivery of the device e.g. intravascularly.

In some embodiments, one or more connection between the expandable body and other element/s is located within the expandable body. For example, within a central 80-99%, or 80-95% of the expandable body. Where connections include, for example, connection between the expandable body and a holder and/or source and/or connection between the expandable body and a portion of a delivery apparatus e.g. push wire.

In some embodiments, a portion of the expandable body is at least partially recessed within a volume of the device defined by walls of the device. For example, at least a portion of the base and/or at least a portion of a top of the expandable device is recessed within a lumen defined by the walls. In some embodiments, recessing is of a portion of the device including one or more connector. For example, a connector holding a portion of the device closed e.g. base closing connector and/or top closing connector. For example, a connector to a push-wire and/or other delivery apparatus portion/s. For example, a connector to a source and/or source holder.

In some embodiments, recessing of a portion to which the source is connected (e.g. base and/or top) moves connection of the source closer to a center of the device walls. A potential advantage of recessing connection of the source to the body is reduced disruption of the source connection to blood flow within the main vessel to which the aneurysm is a deformity.

In some embodiments, a connection of the expandable device to a delivery apparatus (e.g. a push-wire) is recessed within the device.

In an exemplary embodiment, connection of the source and of the delivery apparatus is at the same portion and/or region of the base, which, in some embodiments, is recessed within the expandable body.

In some embodiments, the expandable body includes a top. Where in some embodiments, the top extends from the walls and at least partially encloses a lumen formed by the walls. In some embodiments, the top is closed. In some embodiments, the top includes an opening, which, in some embodiments, provides access for attachment of the source to the expandable body e.g. attachment to the base and/or to the base via a holder attached to the base.

In some embodiments, one or more portion of the expandable structure is multi-layer. Where, for example, in some embodiments, a portion of the base and/or of a top is recessed within a tubular structure defined by the walls. In some embodiments, the base and/or walls are surrounded (e.g. proximally) by a support structure. A potential advantage of a multi-layer structure include increased resilience to collapse of the structure and/or increased scaffolding providing surfaces for growth of thrombi.

In some embodiments, the top is at least partially recessed within the volume described by the walls. A potential benefit of a recessed base and/or recessed top is increased resistance of the expandable device to compression, for example, of the region of the expandable body where the recessed portion/s reinforce (e.g. form a double layer with) walls of the device. In some embodiments, the increased resistance is to compression in a direction perpendicular to a central longitudinal axis of the walls (e.g. tubular walls), for example a radial direction for a cylindrical type expandable body.

A potential benefit of recessed portion/s is increased rate of forming of thrombi within the aneurysm associated with increased scaffolding provided by the recessed portion/s.

In some embodiments, recessed portion/s are formed by folding of material extending from walls of the expandable device within the lumen defined by the walls. For example, a tubular structure forms the walls and end portion/s of the walls are then folded into the tubular structure. In some embodiments, folded end/s are not recessed but extend externally around the walls. For example providing mechanical strengthening of the walls and/or a double layer of mesh providing scaffolding and/or restriction of blood flow e.g. at the aneurysm opening. In some embodiments, folded and/or double layer portion/s are not used at a base of the device, preventing additional material from screening opening of the aneurysm from emitted radiation. Alternatively, in some embodiments, a base includes more than one layer of mesh which in some embodiments, is formed by folding of the material e.g. of the base and/or of walls the folded material extending to form a double layered portion. Potential benefits being increased restriction of blood flow and/or increased mechanical resilience.

In some embodiments, one or more portion of the expandable body is formed from a mesh e.g. a wire mesh. In some embodiments, the mesh material is biocompatible and/or coated in biocompatible material. In an exemplary embodiment, the wire mesh includes nitinol. In some embodiments, pore size of the mesh is selected to reduce blood flow into the aneurysm and/or prevent thrombi from escaping from within the aneurysm. Further exemplary details of the mesh structure are described in the section below entitled “Exemplary expandable body materials”.

In some embodiments, one or more portion of the expandable body includes more than one layer of mesh e.g. is double-layered. Potential benefits of additional layers include increased mechanical resilience (e.g. associated with resistance of the device to collapse) and/or reduced pore size and/or increased scaffolding providing a surface for thrombi to grow within the aneurysm and/or for enothelization at the aneurysm neck. In some embodiments, the base portion is formed at least partially by a multi-layer mesh (e.g. double layer).

In some embodiments, the source is attached to the expandable body by a holder. In some embodiments, the holder is formed of ionizing radiation resistant material for example, an ionizing radiation resistant polymer, e.g. PEEK and/or polyimide. In some embodiments, the source is placed within a lumen of the holder. Where, in some embodiments, once the source is within the lumen of the holder the lumen is closed and/or constricted to prevent movement of the source.

In some embodiments, the source is attached externally to the holder. In an exemplary embodiment, the source is stretched onto the holder, reactive force of the stretching holding the source to the holder.

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

In some embodiments, the holder provides mechanical support to the intravascular device. For example, in some embodiments, delivery of the device is by applying pressure to the holder, for example, through a push-wire connected to the holder. In some embodiments, the holder is elongate. In some embodiments, the holder is flexible axially but resists deformation in a direction of elongation of the holder. Potentially axial flexibility and/or resistance to deformation in a direction of elongation enable delivery of the device e.g. the collapsed device through a delivery lumen (e.g. catheter).

In some embodiments, the holder is directly connected to the expandable body. For example, by welding. For example, by connecting (e.g. adhering, screwing together) two pieces of the holder with the body disposed therebetween.

Alternatively or additionally, in some embodiments, the expandable body is attached to the holder by a portion of the expandable body being disposed between the holder and a 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 holder together e.g. by one or more of crimping, gluing, welding, and quenching. In an exemplary embodiment, the connector is quenched onto mesh of the expandable body and the holder together.

In some embodiments, the expandable body is attached to the holder at one or more place. For example, in some embodiments, both the expandable body base and the expandable body top are attached to the holder. For example, each of the base and the ring by a different connector.

In some embodiments, the walls and base are reinforced by a support (which in some embodiments, includes additional walls optionally connected to a base). In some embodiments, the support is proximal to the expandable body walls and base and optionally connected to the delivery apparatus. Optionally, in some embodiments, the support is attached to the holder.

In some embodiments, the expandable device walls form a tubular shape. In some embodiments, a cross section of the tubular shape is constant along a length of the walls (e.g. varies by at most 10%, or 5% or lower or higher or intermediate percentages). In some embodiments, the cross section is symmetrical about one or more axis e.g. in some embodiments, circular.

In some embodiments, a cross section of the tubular shape changes along the length of the walls e.g. increases in a distal direction, for example, where the expanded device includes sloped walls e.g. has a truncated cone shape extending from the base.

In some embodiments, a cross section of the tubular shape of the walls increases rapidly along a length of the walls, for example, to form a flattened cup shape with the base. For example, in some embodiments, the wall cross section at least doubles, or increases by 1.5-50 times, or 5-20, or about 10 times along the wall length.

In some embodiments, the expandable device is delivered pressure applied to a push-wire, after delivery, the push-wire is detached and removed. In some embodiments, detachment of the push-wire is by electrolytic weakening of a connection between the push-wire and the expandable device. Where, in some embodiments, the push-wire is electrically conducting and a current applied to the push-wire acts to weaken the connection enabling the push-wire to be removed from the treatment site, while leaving the expandable device in situ. Alternatively or additionally, in some embodiments, disconnection of the push-wire is via electrothermal weakening of the connection between the push-wire and the expandable device e.g. where an electrical current is used to heat the connection to weaken it. Alternatively or additionally, in some embodiments, detachment of the push-wire from the device includes a mechanical release e.g. where tension is changed on an elongate element (in some embodiments, the push-wire) to detach the push-wire from the expandable device. In some embodiments, attachment of the push-wire is to the holder. Where, in some embodiments, the holder is electrically insulating, potentially preventing electrical stimulation (e.g. for electrolytic and/or electrothermic detachment of the push-wire from affecting the expandable device and/or adjacent and/or enclosed tissue).

In some embodiments, the device is configured to be reattached to an apparatus for movement of the device. For example, to be reattached to a push-wire. In some embodiments, the device is extracted and/or re-positioned after reattachment e.g. of a push-wire. In some embodiments, a push-wire is magnetically attached and/or detached from the expandable body. For example, via the holder.

In some embodiments, the radioactive source is removed from within the aneurysm e.g. after treatment has been completed, for example, leaving portion/s of the expandable body of the device in situ. For example, in some embodiments, the holder is re-attached to a push-wire and the holder and source are removed from the device.

In some embodiments, the expandable device includes one or more radiopaque marker. For example, in some embodiments, one or more connector (e.g. connection ring) includes radiopaque material. For example, in some embodiments, the mesh of the device itself includes radiopaque material.

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

In some embodiments, a radioactive source is directionally shielded in one or more direction. For example, to prevent radiating sensitive tissue outside the aneurysm e.g. the optic nerve. In some embodiments, shielding portion/s form radiopaque markers e.g. potentially enabling a user to verify correct positioning of the device and/or shield.

In some embodiments, pore size of one or more portion of the device is selected to allow insertion of additional element/s. For example, for insertion of aneurysm treatment coil/s of the art.

Although devices and methods have been described with respect to treatment of aneurysm, in some embodiments, devices and/or methods as described in this document are used for treatment of other tissue. For example for closing lumen/s of other body portions, e.g. left atrial appendage closure.

In some embodiments, devices as described in this document do not include radioactive source/s. For example, in some embodiments, structures as described are used for treatment without a radioactive source. In some embodiments, a device including a source is deployed, and the source is later removed e.g. leaving the device in situ. In some embodiments, a device without a source is deployed.

Optionally, in some embodiments, after a treatment time period, one or more radioactive source is coupled to the device e.g. a device initially lacking source/s. Where, in some embodiments, removal and/or addition of radioactive source's is based on clinical assessment of efficacy of treatment and/or pre-determined in a treatment plan.

A broad aspect of some embodiments of the invention relates to treatment of an aneurysm by deploying an expandable device into the aneurysm. In some embodiments, the device has a double layer (e.g. a body layer and a support layer) which, when the device is deployed, covers an opening of the aneurysm. In some embodiments, one or both layers are formed of mesh e.g. wire mesh.

In some embodiments, the base and walls form a curved surface which, when the device is deployed within an aneurysm is presented to blood flow of vessel/s hosting the aneurysm. In some embodiments, the second layer of the double layer is provided by a support.

In some embodiments, distal portions of the support and the body are not connected and/or the support and body are only connected at the connection region. A potential benefit being ease of delivery through vessels (e.g. tortuous blood vessels) as, for example, in some embodiments, transitioning through turns support and body are able to move with respect to each other.

In some embodiments, the device includes an expandable body which has a range of expanded configurations associated with different aneurysm sizes. Where, in some embodiments, the expandable body conforms, at least partially to a size and/or shape of the aneurysm. In some embodiments, the device expandable body has a single relaxed expanded configuration e.g. when not under external forces of tissue and/or a delivery apparatus.

In some embodiments, the expandable intravascular device covers, at least partially, and, in some embodiments, fully, an opening of the aneurysm. For example, with a mesh where, in some embodiments, a mesh pore size is selected to prevent outflow of thrombi over a certain size from the aneurysm.

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

In some embodiments, the aneurysm is a large or giant aneurysm with a maximal and/or average dimension of 10-25 mm or lower or higher or intermediate dimensions or ranges, with, for example, dome to neck ratio of 0.1-3, or lower or higher or intermediate ranges or ratios.

In some embodiments, once the device is expanded within the aneurysm, the base covers an opening of the aneurysm. For example, in some embodiments, the base and/or walls of the device, in an expanded configuration, are sized and/or shaped to cover the aneurysm.

In some embodiments, a device expanded configuration is over-sized, in one or more dimension, with respect to the aneurysm. A potential benefit being that force of the device on the aneurysm and/or resulting friction and/or close fitting of the device to the aneurysm prevents movement of the device, once expanded. A potential benefit of force and/or friction between the device and aneurysm is wounding and/or irritation to the aneurysm which, in some embodiments, increase a rate of healing and/or treatment. In some embodiments, over-sizing is in one or more direction perpendicular to a plane of the aneurysm opening, and/or in an aneurysm opening to dome direction, which direction designations are herein termed, with respect to the device, a proximal-distal direction and/or a length direction of the expandable device. Additionally, or alternatively, in some embodiments, over-sizing is in one or more direction parallel to a plane of the aneurysm volume and/or perpendicular to the proximal-distal and/or parallel to a width and/or depth direction of the device.

In some embodiments, once the device is expanded within the aneurysm, a distal portion of the device adjacent to and/or in contact with aneurysm walls acts to hold the device in position covering the opening of the aneurysm. For example, where contact of the distal portion of the device (e.g. with aneurysm dome), in some embodiments, is arranged by selection of the device to be over-sized with respect to dimension/s of the aneurysm e.g. in an aneurysm neck to dome direction. In some embodiments, the device is configured, for example, a length of the device extending distally from the base is configured to dispose a distal portion of the device at walls of the aneurysm. Where, in some embodiments, the device is elastically expandable in a proximal-distal direction and a relaxed length of the device is larger than a length of the aneurysm e.g. distance from the aneurysm opening to facing inner walls of the aneurysm.

In some embodiments, the expandable body, when at least partially expanded and positioned within an aneurysm, is sufficiently resistant to forces of tissue 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 e.g. under tissue forces of the aneurysm and/or surrounding tissue. In some embodiments, thrombi formed within the aneurysm prevent collapse of the aneurysm and/or of the expandable body. A potential benefit being reduced likelihood of dislodgement of the device from the aneurysm and/or the aneurysm collapsing leaving a remnant aneurysm neck. In some embodiments, the base and/or walls of the expandable body resist collapse of the aneurysm onto the source. A potential benefit being that healthy tissue surrounding the aneurysm is not irradiated at the radiation levels selected for treatment of the aneurysm.

In some embodiments, one or more portion of the expandable body is sufficiently flexible that the expandable body conforms, at least partially, to a shape of the aneurysm. For example, in some embodiments, portion/s of the expandable body walls (e.g. distal portion/s) of the walls conform, at least partially, to a shape of the aneurysm. A potential benefit being reduced likelihood of the device dislodging from position within the aneurysms.

In some embodiments, the expandable body of the device is self-expanding. For example, elastically self-expanding upon exiting (e.g. being pushed out of) a delivery catheter. In some embodiments, the elastic expanding force of the expandable body is sufficient to resist collapse of the expandable body, potentially reducing the chance of dislodgement of the device from the aneurysm lumen.

In some embodiments, the expandable body is not self-expanding or is only partially self-expanding. In some embodiments, for example, the expandable is balloon expanded e.g. by inflating a balloon positioned within the expandable body.

In some embodiments, one or more connection between the expandable body and other element/s is located within the expandable body. For example, within a central 80-99%, or 80-95% of the expandable body. Where connections include, for example, connection between the expandable body and a holder and/or source and/or connection between the expandable body and a portion of a delivery apparatus e.g. push wire.

In some embodiments, a portion of the expandable body is at least partially recessed within a volume of the device defined by walls of the device. For example, at least a portion of the base and/or at least a portion of a top of the expandable device is recessed within a lumen defined by the walls. In some embodiments, recessing is of a portion of the device including one or more connector. For example, a connector holding a portion of the device closed e.g. base closing connector and/or top closing connector. For example, a connector to a push-wire and/or other delivery apparatus portion/s. For example, a connector to a source and/or source holder.

In some embodiments, recessing of a portion to which the source is connected (e.g. base and/or top) moves connection of the source closer to a center of the device walls. A potential advantage of recessing connection of the source to the body is reduced disruption of the source connection to blood flow within the main vessel to which the aneurysm is a deformity.

In some embodiments, a connection of the expandable device to a delivery apparatus (e.g. a push-wire) is recessed within the device.

In some embodiments, the expandable body includes a top. Where in some embodiments, the top extends from the walls and at least partially encloses a lumen formed by the walls. In some embodiments, the top is closed. In some embodiments, the top includes an opening, which, in some embodiments, provides access for attachment of the source to the expandable body e.g. attachment to the base and/or to the base via a holder attached to the base.

In some embodiments, one or more portion of the expandable structure is multi-layer. Where, for example, in some embodiments, a portion of the base and/or of a top is recessed within a tubular structure defined by the walls. In some embodiments, the base and/or walls are surrounded (e.g. proximally) by a support structure. A potential advantage of a multi-layer structure include increased resilience to collapse of the structure and/or increased scaffolding providing surfaces for growth of thrombi.

In some embodiments, the top is at least partially recessed within the volume described by the walls. A potential benefit of a recessed base and/or recessed top is increased resistance of the expandable device to compression, for example, of the region of the expandable body where the recessed portion/s reinforce (e.g. form a double layer with) walls of the device. In some embodiments, the increased resistance is to compression in a direction perpendicular to a central longitudinal axis of the walls (e.g. tubular walls), for example a radial direction for a cylindrical type expandable body.

A potential benefit of recessed portion/s is increased rate of forming of thrombi within the aneurysm associated with increased scaffolding provided by the recessed portion/s.

In some embodiments, recessed portion/s are formed by folding of material extending from walls of the expandable device within the lumen defined by the walls. For example, a tubular structure forms the walls and end portion/s of the walls are then folded into the tubular structure. In some embodiments, folded end/s are not recessed but extend externally around the walls. For example providing mechanical strengthening of the walls and/or a double layer of mesh providing scaffolding and/or restriction of blood flow e.g. at the aneurysm opening. In some embodiments, folded and/or double layer portion/s are not used at a base of the device, preventing additional material from screening opening of the aneurysm from emitted radiation. Alternatively, in some embodiments, a base includes more than one layer of mesh which in some embodiments, is formed by folding of the material e.g. of the base and/or of walls the folded material extending to form a double layered portion. Potential benefits being increased restriction of blood flow and/or increased mechanical resilience.

In some embodiments, one or more portion of the expandable body is formed from a mesh e.g. a wire mesh. In some embodiments, the mesh material is biocompatible and/or coated in biocompatible material. In an exemplary embodiment, the wire mesh includes nitinol. In some embodiments, pore size of the mesh is selected to reduce blood flow into the aneurysm and/or prevent thrombi from escaping from within the aneurysm. Further exemplary details of the mesh structure are described in the section below entitled “Exemplary expandable body materials”.

In some embodiments, one or more portion of the expandable body includes more than one layer of mesh e.g. is double-layered. Potential benefits of additional layers include increased mechanical resilience (e.g. associated with resistance of the device to collapse) and/or reduced pore size and/or increased scaffolding providing a surface for thrombi to grow within the aneurysm and/or for endothelization at the aneurysm neck. In some embodiments, the base portion is formed at least partially by a multi-layer mesh (e.g. double layer).

In some embodiments, the holder provides mechanical support to the intravascular device. For example, in some embodiments, delivery of the device is by applying pressure to the holder, for example, through a push-wire connected to the holder. In some embodiments, the holder is elongate. In some embodiments, the holder is flexible axially but resists deformation in a direction of elongation of the holder. Potentially axial flexibility and/or resistance to deformation in a direction of elongation enable delivery of the device e.g. the collapsed device through a delivery lumen (e.g. catheter).

In some embodiments, the holder is directly connected to the expandable body. For example, by welding. For example, by connecting (e.g. adhering, screwing together) two pieces of the holder with the body disposed therebetween.

Alternatively or additionally, in some embodiments, the expandable body is attached to the holder by a portion of the expandable body being disposed between the holder and a 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 holder together e.g. by one or more of crimping, gluing, welding, and quenching. In an exemplary embodiment, the connector is quenched onto mesh of the expandable body and the holder together.

In some embodiments, the expandable body is attached to the holder at one or more place. For example, in some embodiments, both the expandable body base and the expandable body top are attached to the holder. For example, each of the base and the ring by a different connector.

In some embodiments, the walls and base are reinforced by a support (which in some embodiments, includes additional walls optionally connected to a base). In some embodiments, the support is proximal to the expandable body walls and base and optionally connected to the delivery apparatus. Optionally, in some embodiments, the support is attached to the holder.

In some embodiments, the expandable device walls form a tubular shape. In some embodiments, a cross section of the tubular shape is constant along a length of the walls (e.g. varies by at most 10%, or 5% or lower or higher or intermediate percentages). In some embodiments, the cross section is symmetrical about one or more axis e.g. in some embodiments, circular.

In some embodiments, a cross section of the tubular shape changes along the length of the walls e.g. increases in a distal direction, for example, where the expanded device includes sloped walls e.g. has a truncated cone shape extending from the base.

In some embodiments, a cross section of the tubular shape of the walls increases rapidly along a length of the walls, for example, to form a flattened cup shape with the base. For example, in some embodiments, the wall cross section at least doubles, or increases by 1.5-50 times, or 5-20, or about 10 times along the wall length.

In some embodiments, the expandable device is delivered pressure applied to a push-wire, after delivery, the push-wire is detached and removed. In some embodiments, detachment of the push-wire is by electrolytic weakening of a connection between the push-wire and the expandable device. Where, in some embodiments, the push-wire is electrically conducting and a current applied to the push-wire acts to weaken the connection enabling the push-wire to be removed from the treatment site, while leaving the expandable device in situ. Alternatively or additionally, in some embodiments, disconnection of the push-wire is via electrothermal weakening of the connection between the push-wire and the expandable device e.g. where an electrical current is used to heat the connection to weaken it. Alternatively or additionally, in some embodiments, detachment of the push-wire from the device includes a mechanical release e.g. where tension is changed on an elongate element (in some embodiments, the push-wire) to detach the push-wire from the expandable device. In some embodiments, attachment of the push-wire is to the holder. Where, in some embodiments, the holder is electrically insulating, potentially preventing electrical stimulation (e.g. for electrolytic and/or electrothermic detachment of the push-wire from affecting the expandable device and/or adjacent and/or enclosed tissue).

In some embodiments, the device is configured to be reattached to an apparatus for movement of the device. For example, to be reattached to a push-wire. In some embodiments, the device is extracted and/or re-positioned after reattachment e.g. of a push-wire. In some embodiments, a push-wire is magnetically attached and/or detached from the expandable body. For example, via the holder.

In some embodiments, the expandable device includes one or more radiopaque marker. For example, in some embodiments, one or more connector (e.g. connection ring) includes radiopaque material. For example, in some embodiments, the mesh of the device itself includes radiopaque material.

In some embodiments, pore size of one or more portion of the device is selected to allow insertion of additional element/s. For example, for insertion of aneurysm treatment coil/s of the art.

An aspect of some embodiments of the invention relates to a low delivery profile (also herein termed “crimped profile”) double layered aneurysm treatment device.

Where, when crimped (e.g. within a delivery catheter), the device maximal cross sectional extent (e.g. diameter) is 200-1400 μm, or 300-1000 μm, or 300-700 μm, or lower or higher or intermediate distances or ranges. In some embodiments, a minimal delivery profile of the device is defined by a cross sectional extent of a connection region of the device and, optionally a layer thickness/es of one or both of the double layers. Where, in some embodiments, the connection region maximal cross section dimension is 100-700 μm, or 200-500 μm, or lower or lower or higher or intermediate distances or ranges. In some embodiments, layer thickness of one or more layer of the device is 50-200 μm, or 50-150 μm, or 50-100 μm, or lower or higher or intermediate distances or ranges. In some embodiments, a double layered device, at a connection region of the device, when the device is in a crimped configuration, has at most, a single surrounding layer of device mesh material (e.g. body and/or support layer material).

In some embodiments, support portion/s of the device extend from the connection region in a different direction to that of body portion/s of the device. In some embodiments, when in a crimped configuration, the body portion (e.g. and not the support portion) surrounds the connection region.

In some embodiments, the double layer is formed by folding a single tubular material portion one or more times to form a support portion and a body portion. Where, in some embodiments, a single end of the tubular material portion is connected at the connection region. In some embodiments, when in a crimped configuration, the device is unbent (e.g. around the connection region) and/or unfolded, the connection region, in some embodiments, laterally not being surrounded by body and/or support material.

In some embodiments, layers of a double-layered device are able to move with respect to each other. For example, in some embodiments, the body and support regions only being connected at a single connection region. For example, in some embodiments, the layers being formed using different tubular portions. A potential benefit being lower porosity (or higher coverage) for the device (e.g. portion/s of the device closing an entrance to an aneurysm) for a given crimped profile. A potential benefit being increase in reliability of expansion of the device after crimping.

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 region and/or where distal ends of the layers of the device are not connected. Where, in some embodiments, a single connection region is positioned at a proximal portion of the device. Where, in some embodiments, a first layer having a base and walls and a second layer having a base and walls, distal ends of the walls of the first layer and distal ends of the walls of the second layer are not connected to each other. In some embodiments, one or both of the first layer and the second layer are open where there is no structure closing and/or reducing an area of distal opening/s as defined by the walls of the layers.

An aspect of some embodiments of the invention relates to ends of portions of a mesh device.

Where, in some embodiments, distal edge portion/s of a device are free mesh e.g. which is un-connected to other element/s and/or extends to possibly contact tissue (e.g. as opposed to being tucked into the device volume and/or held by a connector). In some embodiments, ends of fibers of the mesh are blunted e.g. at least a portion of tips of ends of the mesh. A potential benefit being reduced risk of the ends causing trauma to tissue.

In some embodiments, blunting is by welding and/or coating the tips. In some embodiments, a portion of tips are blunted e.g. a circumferential portion e.g. outlying tips extending further than others from a body of the device.

In some embodiments, mesh filaments are interconnected. Potentially connecting (e.g. of crossing wires) of a mesh increases radial resistance and/or strength of the device and/or prevents delamination of the mesh (e.g. of the mesh weave). In some embodiments, connecting wires of a mesh is by welding and/or adhesive. In some embodiments, connecting is for an end region of the mesh e.g. a region more at risk of delamination. For example, for a region including a distal 0.1-3 mm, or 0.1-1 mm, or lower or higher or intermediate distances or ranges.

Exemplary System

FIG.1is a simplified cross sectional schematic of an intravascular device system100, according to some embodiments of the invention.

In some embodiments, expandable device102has an expandable body108. Where expandable body108has a distal end118and a proximal end114.

In an exemplary embodiment, expandable body108is at least partially formed by a mesh which, inFIG.1is indicated by dashed lines. In some embodiments, holes of the mesh are sized to restrict flow of blood through the mesh and/or to prevent escape of thrombi (e.g. over a certain size) from within a device lumen112.

In some embodiments, one or more portion of the expandable body108is formed by a multi-layered (e.g. double layer) mesh, for example, illustrated inFIG.1by the double layer dashed line. Potential benefits of double-layering include higher resilience of the expandable body to collapse and/or increased reduction of movement of material (e.g. blood and/or thrombi) into and/or out of the aneurysm.

In some embodiments, a lumen112defined by walls110is closed, (e.g. at a proximal114end of the body) by base116. Alternatively or additionally, a distal end118of lumen112is at least partially closed (e.g. as described and/or illustrated elsewhere in this document e.g. regardingFIG.6,FIG.7,FIG.8,FIG.10,FIGS.17A-B).

In some embodiments, a radioactive source104(also herein referred to by the term “source”) is coupled to expandable device102, for example, by a holder106. Alternatively or additionally, in some embodiments, source104is directly attached to body108. For example, by one or more of; welding mesh of body108to source104, crimping body108to source104, by gluing body108to source104.

In some embodiments, holder106is elongate, extending from base116in a distal direction, for example, to position source104at a distance103of 0 to 10 mm, or 0.1-5 mm, or 0.1-3 mm, or 0.5-15 mm, or 1-1.5 mm or lower or higher or intermediate ranges or distances. In some embodiments, holder106and/or source104are positioned centrally with respect to base116and/or expandable body108. For example, within a central 5-80%, or 5-50%, or 5-20%, or lower or higher or intermediate percentages or ranges of base116. Where distance101, for example, is 0.1 mm to 15 mm, or lower or higher or intermediate distances or ranges.

In some embodiments, expandable system100includes a delivery and/or positioning apparatus120. In some embodiments, apparatus120includes an elongated element122which is coupled to expandable device102. In some embodiments, elongated element122is a push-wire.

Optionally, in some embodiments, a connector124connects push-wire122to expandable device102. In an exemplary embodiment, push-wire122is connected to source mount106(directly and/or via a connector124).

Exemplary Methods

FIG.2is a flow chart of a method of treatment, according to some embodiments of the invention.

This flow chart generally describes a method of treatment of aneurysm, however, in some embodiments, relates to treatment of other tissue structure/s e.g. vascular structure/s and in an exemplary embodiment of treatment of the left atrial appendage (LAA).

At200, in some embodiments, a patient is diagnosed, for example by a medical practitioner. In some embodiments, one or more type of measurement is collected from the patient. For example, imaging (e.g. one or more of x-ray, CT, MRI, ultrasound, nuclear imaging) of a site of vascular abnormality (e.g. aneurysm) and/or of a vascular structure (e.g. left atrial appendage). In some embodiments, measurements include a location and/or size and/or shape of the treatment site e.g. including an aneurysm for treatment (e.g. the left atrial appendage).

At201, optionally, in some embodiments, an intravascular device is selected. Where, in some embodiments, the selection is based on the diagnosis e.g. including measurements. For example, in some embodiments, a size and/or shape of expandable body of the device is selected based on measurements (e.g. size and/or shape measurements) of the vascular region (e.g. aneurysm, e.g. left atrial appendage LAA) to be treated.

In some embodiments, a size and/or shape of an expandable body, for example, including size and/or shape of a base and/or walls of the device, is selected so that the expandable body covers an opening of the treatment site (e.g. opening of the aneurysm, e.g. LAA opening) e.g. covers at least 50-95%, or at least 80-90%, or at least 90%, or lower or higher or intermediate percentages or ranges of the opening area.

In some embodiments, a length of the device is selected so that the device, when expanded within the aneurysm (or LAA) extends from a top of the aneurysm (or LAA) to the aneurysm opening, the size and/or shape of the device holding a proximal portion (e.g. including the base of the expandable device) in position to close the opening of the aneurysm (or LAA).

In some embodiments, a size and/or shape of the expandable body in an expanded relaxed configuration is selected so that the expanded body within the aneurysm is larger than the aneurysm opening in one or more direction. Where, in some embodiments, over-sizing and/or elastic relaxation force are selected to provide sufficient force (e.g. outwards force from a center of the device e.g. radial force) between the device and aneurysm wall to hold the device in position within the aneurysm (or LAA).

In some embodiments, a radioactive source of the intravascular device is selected. The source, for example, being selected based on the aneurysm size and/or shape and/or type. In some embodiments, for example, a larger dose and/or higher dose rate source is selected for a larger aneurysm. In some embodiments, the radioactive source includes more than one element, for example, where the radioactive elements are positioned at different regions of the expandable structure and/or aneurysm (e.g. including one or more feature as illustrated in and/or described regardingFIGS.29A-Band/orFIGS.30A-B). Where, in some embodiments, positioning of the radioactive elements is selected based on the size and/or shape and/or type of aneurysm (or LAA) to be treated.

In some embodiments, directional shielding of the source is selected. For example, to prevent irradiating particular tissue e.g. outside the aneurysm. For example, the optic nerve. In some embodiments, a shielding element is selected and optionally attached to the device and/or delivered through a catheter for positioning e.g. after the device is in position.

In some embodiments, selection is from a kit including a range of expandable bodies (e.g. as described regardingFIGS.12A-F) and/or a range of radioactive sources. Where, in some embodiments, once a device is selected, the selected source is attached to the selected expandable body.

At202, in some embodiments, a radioactive source is coupled to an expandable intravascular device.

Where the expandable device includes, for example, one or more feature as illustrated in and/or described regarding one or more of intravascular devices ofFIGS.1,4A-H,5-10,11,12A-H,13A-C,14A-C,15A-B,16A-B,17A-B.

Where coupling of the radioactive source includes one or more feature as illustrated in and/or described regarding one or more ofFIG.11,FIGS.19A-C,FIGS.20A-C,FIG.21,FIGS.22A-B, andFIGS.23-26.

In some embodiments, radioactive source's are attached to the expandable device using a mounting tool. Where, in some embodiments, the tool allows a user to attach the radioactive source to expandable device without directly contact the source and/or device. Potentially maintaining sterility of the device and/or protecting the user from radiation exposure.

At203, optionally, in some embodiments, the expandable device is connected to one or more portion of a delivery apparatus e.g. to a push-wire. Alternatively, in some embodiments, the expandable device is provided (e.g. prior to coupling of the radioactive source at step200) pre-attached to a push-wire and/or delivery apparatus.

At204, optionally, in some embodiments, the expandable device is compressed. Alternatively, in some embodiments, the expandable device is provided pre-compressed e.g. where coupling of the radioactive source is to a compressed device.

At206, in some embodiments, the device is loaded into a delivery catheter. In some embodiments, steps204and206are combined where compressing is achieved, at least partially, positioning the expandable device within the delivery catheter. For example, by withdrawing the expandable device into the catheter and/or pulling the catheter over the expandable device.

At207, optionally, in some embodiments, tissue wounding is performed at the aneurysm site. For example, wounding to the aneurysm neck and/or sac. In some embodiments, wounding is mechanical wounding. Alternatively or additionally, wounding is chemical e.g. via chemical agent/s. In an exemplary embodiment, the expandable device system is moved to inflict friction wounding on the aneurysm neck where the expandable device itself and/or push-wire and/or other portion/s of the expandable device delivery apparatus are moved against the aneurysm neck to wound it. Where the movement is backwards and forwards and/or rotational movement.

At208, in some embodiments, the expandable device is delivered to an region of an aneurysm, for example, to an entrance of the aneurysm. Where, in some embodiments, the device is delivered in a contracted and/or crimped configuration within a catheter. In some embodiments, where the expandable device is elastically expandable, the device is restrained from expanding by walls of the catheter. For example, as part of a catheterization procedure. In some embodiments, delivery is assisted by imaging. In some embodiments, the expandable device is intravascularly delivered e.g. through a catheter e.g. movement of the device effected by pressure applied to a push-wire connected to the device.

At210, in some embodiments, the expandable device delivered to the aneurysm and expanded within the aneurysm. Where, in some embodiments, delivery and expanding are simultaneous e.g. a self-expanding device being delivered into the aneurysm sac whilst exiting a delivery catheter. In some embodiments, a self-expanding device expands towards a relaxed configuration within the aneurysm. In some embodiments, the device expands to the relaxed confirmation. Alternatively in some embodiments, the aneurysm sac prevents the device from expanding fully and/or the device conforms at least partially to a shape of the aneurysm sac (e.g. the configuration of expandable device402FIG.4Hand/or of expandable device1202FIG.12E). Where, for example, in some embodiments, elastic relaxation force of one or more portion of the expandable device is less than the resistance to expansion of portion/s of the aneurysm walls, shape of expandable device, at least partially conforming to a shape of the aneurysm.

Alternatively, in some embodiments, the device is delivered and then expanded afterwards e.g. where the device is mechanically expanded (e.g. balloon expansion) and/or where a restraining element (e.g. catheter) is withdrawn after the device is within the aneurysm.

At212, in some embodiments, delivery apparatus (e.g. the push-wire) is disconnected from the expandable device. Where, in some embodiments, detachment is by one or more of mechanical detachment, electrolytic detachment and electrothermal detachment.

For example, where disconnecting includes one or more feature as illustrated in and/or described regarding detachment region2392FIG.23.

At214, in some embodiments, the delivery apparatus, for example, including the push-wire and/or catheter are retracted e.g. from the subject's body.

FIG.3is a flow chart of a method of treatment, according to some embodiments of the invention.

At300, in some embodiments, blood flow into and/or out of an aneurysm is reduced. For example, mechanically, by a mesh at least partially blocking an entrance to the aneurysm.

At302, in some embodiments, thrombi formation within the aneurysm sac is stimulated e.g. by exposure of the aneurysm lumen to low level radiation e.g. the radiation levels including one or more feature as described in the section of this document entitled “Exemplary radiation levels”.

At304, in some embodiments, migration of formed clots (e.g. above a certain size) within the aneurysm to outside the aneurysm is prevented. For example by mesh blocking a passage of thrombi within the aneurysm and/or within a volume defined by the mesh structure to a lumen of a blood vessel to which the aneurysm is a deformity.

At306, in some embodiments, closure of the entrance to the aneurysm is stimulated.

Optionally, in some embodiments, stimulation includes wounding (e.g. mechanical and/or chemical) of tissue of the entrance to the aneurysm (also termed in this document “aneurysm neck”).

In some embodiments, stimulation includes exposure to low level ionizing radiation. Which, in some embodiments, stimulates closure of the aneurysm neck by enothelization of the mesh over the aneurysm neck followed by neointimal formation.

FIGS.4A-Hare simplified schematic cross sections showing treatment of an exemplary aneurysm426, according to some embodiments of the invention.

Referring toFIG.4A, in some embodiments, an expandable device402is delivered in a collapsed configuration by a delivery apparatus420to an opening of aneurysm426. Where, in some embodiments, delivery apparatus420includes a catheter428and expandable device402is delivered through catheter428. In some embodiments, when collapsed (e.g. within catheter428) an expandable body408of expandable device402is collapsed against a mount406which hosts a radioactive source402.

Referring toFIG.4B, in some embodiments, expandable device402is delivered to aneurysm426. Referring toFIG.4C, in some embodiments, expandable device402is expanded within aneurysm426. Where delivery and/or expanding includes one or more feature as illustrated in and/or described regarding step210FIG.2.

In some embodiments, once expanded, the expandable device402is moved e.g. using push-wire422. For example, to wound tissue e.g. as described in stepFIG.2. For example, to position and/or reposition the expandable device within aneurysm426.

Referring toFIG.4D, in some embodiments, once the device is positioned within aneurysm426, delivery apparatus420is removed.

In some embodiments, expandable device402is configured to hold a base of device402in position (e.g. touching tissue around the opening) to close aneurysm opening at aneurysm neck430. In some embodiments, in a proximal-distal direction a length409of expandable device is selected, with respect to a length411of the aneurysm to hold the device in position. In some embodiments, expandable device402is selected so that, at least in a length dimension, the expandable device, in a relaxed configuration, is larger than the aneurysm length411so that the elastic expansion force of device402on aneurysm426walls holds device in position. In some embodiments, the force is not sufficient to deform the walls of the aneurysm and/or is not sufficient to weaken the walls of the aneurysm. Where, for example, in some embodiments, for one or more direction (e.g. at least length e.g. all directions) the relaxed device dimension in that direction is at most 5-50%, or 5-20%, or 5-10%, or lower or higher or intermediate percentages or ranges larger than a maximum dimension and/or average dimension of the aneurysm (e.g. in that direction).

In some embodiments, expandable device402includes an additional expandable support which, in some embodiments, extends from expandable body408e.g. to contact aneurysm426. For example, including one or more feature as illustrated in and/or described regarding support1682FIGS.16A-B.

In some embodiments, expandable device402expands in width407and/or is sized and/or shaped to hold device402in position at the aneurysm opening. Where, in some embodiments, the expandable device does not contact a roof of the aneurysm and/or does not fill a length411of the aneurysm.

In some embodiments, an aneurysm neck width405is 0.5-20 mm, or 1-15 mm, or 2-13 mm or lower or higher or intermediate widths or ranges.

In some embodiments, an average and/or maximal dimension of the aneurysm e.g. height411and/or width413is 0.5-20 mm, or 2-15 mm, or 2-14 mm, or 2-13 mm, or lower or higher or intermediate dimensions or ranges. In some embodiments, (e.g. in a relaxed configuration) a width407and/or length409of expandable body408is 1-20 mm, or 2-15 mm, or 3-14 mm, or lower or higher or intermediate dimensions or ranges.

Referring toFIG.4E, in some embodiments, thrombi432form (e.g. according to one or more feature as described in and/or illustrated regarding step304FIG.3) within expandable device402and/or between expandable device402and aneurysm426walls.

Referring toFIG.4F, in some embodiments, tissue growth (e.g. according to one or more feature as described in and/or illustrated regarding step306FIG.3) at aneurysm neck430acts to close aneurysm426. Where, in some embodiments, tissue first begins to grow onto mesh of expandable device402e.g. as illustrated by dashed line431. After which, in some embodiments, tissue continues to grow to close the entrance to the neck. For example, as illustrated inFIG.4G. In some embodiments, closure of the neck is achieved while expandable device402remains expanded within the aneurysm.

Alternatively, in some embodiments, referring toFIG.4G, aneurysm426sac begins to contract, collapsing onto expandable device402. In some embodiments, aneurysm426continues to contract. In some embodiments, contraction of aneurysm partial collapses expandable device402e.g. as illustrated inFIG.4H.

Exemplary Expandable Devices

FIGS.5-10are simplified schematic cross sectional views of exemplary expandable devices.

In some embodiments, each device502,602,702,802,902, and1002, has a proximal end114and a distal end118and includes tubular walls110, a source104which, in some embodiments, is attached to a body of the expandable device via a mount106.

All ofFIGS.5-10illustrate exemplary embodiments where, for at least the cross section illustrated inFIGS.5-10, source104is located at a central region of the expandable device in a direction perpendicular to a proximal-distal direction. In some embodiments, source is located at a central region of the device is all directions perpendicular to the proximal-distal direction.

FIG.5,FIG.6, andFIGS.8-10illustrate exemplary embodiments where source104is positioned within a central region of the expandable device in a proximal-distal direction.FIGS.5-9illustrate exemplary embodiments where source104and/or holder106are attached to a base of the device; bases516,616,716,816.

FIGS.6-8andFIG.10illustrate exemplary embodiments where the device includes a closed top640,740,840,1040.

FIG.5andFIG.9illustrate exemplary embodiments including a top with an opening540,940.

In some embodiments, expandable devices experience (e.g. at a treatment site e.g. within an aneurysm) to forces151,151. For example, compressive forces151in a proximal-distal direction and/or forces153in a direction perpendicular to the proximal-distal direction (e.g. axial direction).

In some embodiments, a shape of a recessed portion (e.g. base and/or top) provides structural resilience to contraction and/or collapse in the proximal-distal direction e.g. embodiments illustrated inFIGS.6,FIG.8, andFIG.10.

In some embodiments, closure, even if only partial, of a top (or base) provides increased structural resilience in the proximal-distal direction e.g. as illustrated in all ofFIGS.5-10where, for example, partial closure e.g. as illustrated for top540FIGS.5and/or940top, base916FIG.9.

FIG.5illustrates an exemplary embodiment where base516is partially recessed within walls510and where device502lacks a top (or where the top partially covers a lumen defined by walls110.

FIG.6illustrates an exemplary embodiment where both base616and top640are partially recessed within walls610.

FIG.7illustrates an exemplary embodiment including both a closed base716and a closed top740where neither base716nor top740are recessed. In some embodiments, source104and/or holder106are disposed at a proximal end of expandable device702.

FIG.8illustrates an exemplary embodiment where both a base816and a top840are closed and/or recessed.

FIG.9illustrates an exemplary embodiment where both a base916and the top940are open and a support structure970connects source104and/or holder106to walls110.

FIG.10illustrates an exemplary embodiment where source104and/or holder106are attached to a top1040(and not to a base1016). Where, in some embodiments, both base1016and top1040are closed. In some embodiments, top1040is recessed and base1016is not recessed. Alternatively both top1040and base1016are recessed, e.g. without base1016being attached to source104and/or support106.

FIG.11is a simplified view of an expandable device1102, according to some embodiments of the invention.

In some embodiments, expandable device1102includes an expandable body1108with walls1110and a base1116. In some embodiments, one or more portion of body1108is formed from mesh e.g. flow diverter braided mesh (e.g. including one or more feature as described in the section of this document entitled “Exemplary expandable body materials”). Optionally, in some embodiments, body1108includes a top1140.

In some embodiments, arrow1109illustrates a proximal distal direction for device1102where, in some embodiments, base1116is proximal of top1140.

In some embodiments, length1109, width1107and/or depth1160(where, in some embodiments, cross section1121is symmetrical) are 1-20 mm, or 2-15 mm, or 3-14 mm, or lower or higher or intermediate dimensions or ranges. In some embodiments, walls1110form a tubular structure. Where, in some embodiments, a lumen enclosed by the walls maintains a constant cross section along a length1109of walls1110. In some embodiments, base1116closes a proximal end of walls1110. In some embodiments, length1109is 1-20 mm, or 2-10 mm, or 2-15 mm, or 3-14 mm, or lower or higher or intermediate dimensions or ranges.

In some embodiments, a length1109to width1107and/or depth1160ratio is 1:1 to 1:10, or 1:1 to 1:5, or lower or higher or intermediate ratios or ranges.

In some embodiments, expandable device1102includes a source holder1138connected to expandable body1108e.g. at base1116. For example, at a central region of base, for example, where in some embodiments, holder1136and/or a holder cross section1119center1117is disposed within a central region of a cross section1121of expandable body1108where the cross section is taken parallel to base1116and/or perpendicular to walls1110. For example, where holder cross section1119and/or center1117is in a central region of expandable body cross section1121e.g. where centre1117is disposed within a central region of expandable body cross section1121width1107and/or depth1160. Where, in some embodiments a central region is defined as being a central 5-80%, or 5-50%, or 5-20%, or lower or higher or intermediate percentages or ranges of a length and/or cross section area.

In some embodiments, holder includes a lumen1146sized and/or shaped to receive a radioactive source. In some embodiments, a holder cross section average and/or maximum cross sectional dimension1109is 0.05-1 mm, or 0.05-0.5 mm, or 0.1-0.4 mm or lower or higher or intermediate ranges or dimensions. In some embodiments, holder1106extends within a majority of length1109of device e.g. 50-95%, or 50-80%, or lower or higher or intermediate percentages or ranges, of device length. Alternatively, in some embodiments, holder is short with respect to length1109, with a length of at most 50%, or 5-30%, or lower or higher or intermediate ranges of percentages of a device length1109. In some embodiments, a long holder holds a short (e.g. less than 50% of the holder lumen's length) source, potentially enabling selection of positioning within the holder of the source and/or enabling loading of the holder with more than one source e.g. as illustrated inFIG.27where holder2706holds two sources2704a,2704b.

In some embodiments, lumen1146is defined by a plurality of arms1136. In some embodiments, arms1136are connected at a proximal end by a holder base1136. In some embodiments, holder base1136is connected to expandable body1108base1116.

In some embodiments, portion/s1134,1136form a cap for holder1138. In some embodiments portion1134is an attachment for a push-wire (not illustrated) to expandable body1108. In some embodiments, attachment1134is a screw attachment, including threading on connector1134and/or portion1136. Where, in some embodiments, to detach a push-wire, portion1136is unscrewed from portion1134. Other attachment mechanisms (e.g. as described elsewhere in this document) between portions1134,1136are envisioned and encompassed.

In some embodiments, holder1138is connected to expandable body1108by a connector which, in some embodiments, has a ring shape and/or is optionally radiopaque. Where, in some embodiments, connection is by one or more of crimping, welding, and quenching.

Optionally, in some embodiments, arms1136are connected in one or more additional position distal of holder base1136(not illustrated) additional connection/s potentially reinforcing the holder.

In an exemplary embodiment, distal ends1135of arms1136are shaped to prevent a source from exiting lumen1146distally. For example, in some embodiments, distal ends1135of arms1136curve to reduce a cross section of lumen1146e.g. at a distal end of lumen1146. Alternatively, or additionally, in some embodiments, holder includes a base attached to the arms1136e.g. at distal ends1135of the arms.

Optionally, in some embodiments, holder1138includes a cap1134which, in some embodiments, is sized and/or shaped to prevent a radioactive source within lumen1146from falling out. In some embodiments, cap1134closes an end of lumen1146. Alternatively, in some embodiments, cap1134constricts the opening of lumen1146to a size smaller than allows passage of the radioactive source. In some embodiments, cap1134connects to holder by a screw mechanism. For example, where cap1134and/or holder base1136include threading. In some embodiments, cap1134and/or holder1138include one or more feature of cap2499and/or holder2406as described regarding and/or illustrated inFIG.24.

Optionally, in some embodiments, once the radiative source is positioned within lumen1146it is fixed into position, for example by deforming one or more arms1136e.g. towards the radioactive source. In embodiments where the arms are deformed, cap1134is optional.

FIGS.12A-Fare simplified schematic views of an expandable device1202, according to some embodiments of the invention.

FIG.12Ais a simplified schematic view of an expandable device1202, from a distal direction, according to some embodiments of the invention.

FIG.12Bis a simplified schematic side view of an expandable device1202, according to some embodiments of the invention.

In some embodiments,FIGS.12A-Dillustrate expandable device1202in a relaxed configuration e.g. without externally applied forces on the expandable device1202.

In some embodiments, expandable device1202has an expandable body1208which includes walls1210and a base1216. Walls1210and base1216, in some embodiments, form a flattened cup shape, for example, when device1202is in a relaxed expanded configuration. Where, in some embodiments, a width1207and/or height1260of the shape formed by walls1210and base1216is at least 1.5 times, or at least double, or 1.5-10 times or 3-10 times or, 3-7 times or about 5 times a thickness1209of the shape.

In an exemplary embodiment, a kit of expandable bodies (e.g. where one of the bodies is selected for treatment of a particular aneurysm e.g. based on size of the aneurysm) includes devices with width of 5 mm, 7 mm, 9 mm, 11 mm and 14 mm (and/or height1260, for example, in embodiments where the device is rotationally symmetric about a central distal proximal axis1299). Where, in some embodiments, for the kit, thickness is 3-7 times the height and/or of width.

In some embodiments, the device is symmetrical about one or more axis (e.g. when in a relaxed configuration). For example, in some embodiments, width1260and height1207of expandable body1208are the same, e.g. within 10%, or 5%, or 2%, or lower, or higher, or intermediate percentages of each other. In an exemplary embodiment maximum and/or average width1260and/or height1207are 1-20 mm, or 2-20 mm, or 4-15 mm, or lower or higher or intermediate dimensions or ranges. In some embodiments, expandable device includes one or more support1240. In some embodiments, support1240reinforces walls1210and/or supports a radioactive source (radioactive source not illustrated inFIGS.12A-B).

In some embodiments, support1240is large with respect to walls1210, for example, with a maximal and/or average cross sectional dimension (and/or height1215and/or width1262) which are 40-110%, or 50-100%, or 60-90%, or lower or higher or intermediate percentages or ranges of the equivalent dimension for walls1210. Where a large support potentially strengthening device1202potentially preventing collapse of the device and/or providing strong blockage of flow of fluid into and/or out of aneurysm.

Alternatively, in some embodiments, support1240is smaller, for example, with a maximal and/or average cross sectional dimension (and/or height1215and/or width1262) which are 1-20%, or 1-10% or lower or higher or intermediate percentages or ranges of the equivalent dimension for walls1210. Where a smaller support potentially facilitates crimping and/or deployment of device1202.

In some embodiments, the radioactive source is enclosed by expandable structure1208where, for example, the source is enclosed proximally by base1216and walls1210and is enclosed distally by support structure1240(except for, in some embodiments, opening1248in support structure1240). In some embodiments, with respect to description elsewhere in this body support structure1240and/or a distal surface of support structure1240is considered to be a top to the device.

In some embodiments, opening1248provides access to an inner volume of expandable device1202, e.g. for affixing the radioactive source within expandable body1208. In some embodiments, opening1248has small area, for example, at most 1-10%, or 1-5%, or lower, or higher, or intermediate percentages or ranges of a cross section of maximal extent of walls1210(e.g. as illustrated by dimension1260,1207).

FIG.12Cis a simplified schematic cross sectional view of an expandable device1202, according to some embodiments of the invention.

In some embodiments,FIG.12Cshows a cross section taken at a central axis of expandable device1202e.g. along line A-A marked inFIG.12A.

FIG.12C, in some embodiments, illustrates a radioactive source attached1204to expandable body1208by a holder1206.

In some embodiments, source1204is attached to holder1206as described and/or illustrated regarding one or more ofFIGS.19A-C,FIGS.20A-C,FIG.21,FIGS.22A-B,FIGS.23-26.

In an exemplary embodiment, source1204is attached to holder1206by elastically deforming the source1204in attaching the source to the holder, such that elastic relaxation force of the source holds it onto the holder. Where, for example, in some embodiments, the source is wound around the holder1206one or more times e.g. is a coil shape. Where, in some embodiments, a wound on and/or wrapped around source is optionally elastically deformed in the attachment e.g. a relaxed lumen of the source is smaller than an external dimension of the holder1206where the source is attached.

In some embodiments, holder1206is attached to expandable body by a connector1266. In some embodiments, connector1266has a ring shape. Optionally, in some embodiments, connector1266includes radiopaque material. In some embodiments, holder1206and source are not illustrated inFIGS.12A-B. In some embodiments, holder1206extends away (e.g. distally) from expandable body. A potential advantage of which is the ability to position source1204within a central region of the aneurysm e.g. as illustrated inFIG.12F. A potential disadvantage of an extending holder1206is increased risk of rupture of aneurysm1226by the holder e.g. during delivery and/or deployment of device1202.

In some embodiments, support structure1240includes more than one layer. Where, in an exemplary embodiment, support structure1240is a loop extending from a central region of device1202. In some embodiments, support structure1240is connected to the radioactive source1204, for example, at a central region (e.g. central 20%) of the support structure.

In some embodiments, support structure1240provides additional layers (e.g. of mesh) providing blocking of the aneurysm opening. In some embodiments, support structure1240potentially provides additional mechanical resistance to collapse of the device.

FIG.12Dis a simplified schematic top view, from a proximal direction, of an expandable device1202, according to some embodiments of the invention.

FIG.12Eis a simplified schematic cross section of a collapsed expandable device1202, according to some embodiments of the invention.

In some embodiments, for example, as illustrated in and/or described regardingFIG.2, expandable device1202is delivered to a treatment site in a collapsed configuration. Where, in some embodiments, the device is collapsed by being inserted into a catheter1256. In some embodiments, the device is delivered through catheter1256.

In some embodiments, in a collapsed configuration within a catheter1256, the expandable body is extended so that portion/s do not overlap, the expandable body forming a single layer tubular structure within the catheter.

FIG.12Fis a simplified schematic cross section of an expandable device1202within an aneurysm1226, according to some embodiments of the invention.

In some embodiments, walls1210and/or support structure1240conform, at least partially to a shape of aneurysm1226. For example, walls1210and/or support structure1240bending away from a relaxed configuration towards a central region of the device and/or towards the source1204. In some embodiments, expandable device1202bends in to a hemispherical shape.

A potential advantage of an expandable device1202which at least partially conforms to the aneurysm is the ability to deliver the device to the aneurysm from a variety of different angles and have the device walls be able to block the opening of the aneurysm.

Expandable device1202, in some embodiments, presents a gentle curve at a proximal portion of the device, at least when the device is deployed within an aneurysm, (e.g. curve provided by base1216and/or walls1210). In some embodiments, the gentle curve shape is, additionally or alternatively, provided by bending of walls1210as they conform to the aneurysm shape. A potential benefit of the gentle curve is that for a range of different rotational orientations of the expandable device1202within aneurysm1226, the surface of the device is non-disruptive to flow of fluid (e.g. associated with reduced risk of clotting) through the vessel to which the aneurysm is a deformity.

In some embodiments, (not illustrated), walls1210and optionally base1216are formed of a double layer mesh, potentially providing increased reduction of flow between aneurysm1226inner volume and the vessel to which aneurysm1226is a deformity and/or increased scaffolding potentially increasing rate of growth of tissue to close the opening of the aneurysm.

FIG.12Gis a simplified schematic cross sectional view of an expandable device1202, according to some embodiments of the invention.

In some embodiments,FIG.12Gshows a cross section taken at a central axis of expandable device1202e.g. along line A-A marked inFIG.12A.

FIG.12His a simplified schematic cross section of an expandable device1202within an aneurysm1226, according to some embodiments of the invention.

In some embodiments, the device as illustrated in and/or described inFIGS.12A-Fincludes an alternative connection of a source1204to an expandable body1208(e.g. alternative than that illustrated inFIG.12CandFIG.12F).

In some embodiments, source1204is disposed proximally of a connector1266(e.g. proximal position of a source including one or more feature illustrated in and/or described regarding source2604and/or holder2606, and/or connector2666,FIG.26).

In an exemplary embodiment, source1204is attached to holder1206by elastically deforming the source1204in attaching the source to the holder, such that elastic relaxation force of the source holds it onto the holder. In some embodiments, the source is wound around the holder1206one or more times e.g. is a coil shape. Where, in some embodiments, a wound on and/or wrapped around source is optionally elastically deformed in the attachment e.g. a relaxed lumen of the source is smaller than an external dimension of the holder1206where the source is attached.

In some embodiments, connector1266holds mesh portions together without a holder therebetween e.g. without support1206therebetween (e.g. in some embodiments, connector1266is directly connected e.g. welding of the mesh and/or quenching of the connector onto the mesh). In some embodiments, source1204is a coil and/or ring directly attached e.g. crimped onto mesh of expandable body1208e.g. without support1206therebetween.

Where neither connector1266nor source1204hold mesh onto holder1206, holder is optional. In some embodiments, source1204itself connects the mesh where both holder1206and connector1266are optional.

FIGS.13A-Bare simplified schematic sectional views of an expandable device1302, according to some embodiments of the invention.

FIG.13Cis a simplified schematic cross sectional view of a portion of an expandable device1302, according to some embodiments of the invention.

In some embodiments,FIGS.13A-BandFIG.13Cshow the same expandable device1302.

In some embodiments, expandable device1302includes an expandable body1308having walls1310and a base1316. In some embodiments, a shape of walls1310includes one or more feature as illustrated and/or described regarding walls1110FIG.11.

In some embodiments, base1316includes a recessed central portion1360. A potential benefit of which is recessing of connection/s (e.g. of base1368and/or of holder1306and/or of push-wire1322) away from flow within the lumen to which the aneurysm is a deformity. In some embodiments, recessed portion1360is a small portion of an area of base1316, potentially preventing formation of large thrombi within the recession. Where, in some embodiments, for cross sections taken perpendicular to a direction of elongation of walls1310and/or in a proximal-distal direction, recessed portion1360is at most 1-30%, or 1-20%, or lower or higher or intermediate percentages or ranges of an area of the wall cross section. Where, in some embodiments, recessed portion1360is maximally 0.1-5 mm2, 0.1-3 mm2or lower or higher or intermediate ranges or areas in extent for cross sections taken perpendicular to a direction of elongation of walls1310and/or in a proximal-distal direction. In some embodiments, recession is to a depth of 0.5-20 mm, or 0.5-10 mm, or 0.5-5 mm, or 1-5 mm, or lower or higher or intermediate ranges or distances.

In some embodiments, an expandable body distal end1318includes a top1380which partially closes the lumen defined by walls1310. For example, partially closing leaving a distal opening in expandable device1308where a maximal cross sectional dimension1323of the opening is 70-99% or 80-99%, or lower or higher or intermediate ranges or percentages, of a maximal cross sectional dimension1307of walls1310.

In some embodiments, device1302includes a support1362which, in some embodiments, extends from top1380and/or walls1310at a distal end1318of expandable body1308. In some embodiments, support1362is recessed within walls1110. In some embodiments, moving proximally from distal end1318, support1362extends towards a central region of a volume defined by walls1310. To form, in some embodiments, a truncated cone portion where the tip of the cone points in a proximal direction. A potential advantage of support1362is increase resistance of the device to collapse and/or compaction in a proximal-distal direction. In some embodiments, lack of connection of proximal ends of support1362potentially means that there is no connection structure e.g. with associated benefits as described in the next paragraph. This, in some embodiments, at expense of risk of unravelling and/or delamination of wiring at the proximal ends.

A potential advantage of not connecting distal ends of walls1310(e.g. to form a top) and/or recessing a distal wall connection within walls1310(e.g. as illustrated by connection1770FIG.17B) is reduced risk that the connection protrudes and injures and/or ruptures the aneurysm e.g. as the expandable device is delivered and/or expanded. In some embodiments, expandable body1308includes a wall support structure1362which, in some embodiments, is a recessed portion extending from top1380.

Potential advantages of recessed portion/s e.g. portion1360and/or portion1362include one or more advantage described in the “overview” section of this document. For example, one or more of; positioning the source in a central region of the device, reduced disruption to vessel blood flow of connections to body, increased scaffolding for tissue healing; increased mechanical resistance to collapse of the device.

In some embodiments, expandable device1302includes a holder1306for a radioactive source (the source is not illustrated inFIGS.13A-B).

In some embodiments, holder1306is attached to base1316e.g. to recessed portion central portion1366of base1316. In some embodiments, holder1306is held at a central region of expandable device1308. For example, at a central region of base, for example, where in some embodiments, holder1336and/or a holder cross section center1317is disposed within a central region of a cross section1121of expandable body1308where the cross section is taken parallel to base1316and/or perpendicular to walls1310. For example, where holder cross section and/or center1317is in a central region of expandable body cross section1321e.g. where center1317is disposed within a central region of expandable body cross section1321width1307and/or depth1360. Where, in some embodiments a central region is defined as being a central 5-80%, or 5-50%, or 5-20%, or lower or higher or intermediate percentages or ranges of a length and/or cross section area.

In some embodiments, holder1306includes material which is resistant (e.g. maintains its mechanical characteristics) to ionizing radiation. In some embodiments, holder1306includes electrically insulating material (e.g. when electro-chemical detachment is used to detach the push-wire). In an exemplary embodiment, holder1306includes polymer (for example, ionizing radiation resistant polymer e.g. PEEK and/or polyimide and/or cyanoacrylate) and, in some embodiments, is formed of polymer. In some embodiments, a radioactive source is mounted on holder1306, for example, a distal portion of the holder. In some embodiments, holder1306connects push-wire1322to expandable body1308. For example, in an exemplary embodiment holder1306includes a lumen1364into which a distal end of push-wire1322is inserted. In some embodiments, connection between push-wire1322and holder1306is by adhesion. For example, thermal adhesion where the junction is heated to adhere material of holder1306onto push-wire1322. For example, by gluing e.g. where glue is applied to the push-wire and/or support1306before contacting them (e.g. inserting push-wire into lumen1364). In some embodiments, gluing is using cyanoacrylate glue. In some embodiments, at least a portion of holder1306is formed from cyanoacrylate where the cyanoacrylate performs both adhesion, mechanical support (including resistance to ionising radiation) and optionally electrolytic and/or eletrothermal isolation roles e.g. as described with reference to exemplary holders within this document.

Referring now toFIG.13C(although feature/s described in this paragraph are also illustrated inFIGS.13A-B). In some embodiments, holder1306is attached to base1316, for example, by a connector1366which, in some embodiments, holds a portion1368of base1316onto holder1306. In some embodiments, connector1366is ring shaped. Optionally, in some embodiments, connector1366includes radiopaque material.

Optionally, in some embodiments, recessed portion1362is attached to one or both of base1366and/or holder1306(not illustrated inFIGS.13A-B). In some embodiments, portion1362is held together with base1366onto holder1306by connector1366. Alternatively or additionally, in some embodiments, a second connector (e.g. a second ring) connects portion1362to holder1306.

FIG.14Ais a simplified schematic sectional view of an expandable device1402, according to some embodiments of the invention.

FIGS.14B-Care simplified schematics of an expandable device1402, according to some embodiments of the invention.

In some embodiments,FIG.14AandFIGS.14B-Cillustrate the same expandable device1402.

In some embodiments, expandable device1402includes an expandable body1408having a base1416(at a proximal end of expandable body1408), walls1410and a top1440(at a distal end of expandable body1408).

In some embodiments, walls1410are tubular and have an expanding cross section distally. In some embodiments, a width1415of the proximal end of walls1410(which, in some embodiments corresponds to a width of base1416) is larger than a width of a distal end of walls1407(which, in some embodiments corresponds to a width of top1440) where the widths are of the same cross section of the device e.g. as illustrated inFIG.14A. In some embodiments, walls1410gently splay from base1416where distal width1407is 1.05-2 times, or 1.1-1.5 times, or about 1.3 times, or lower or higher or intermediate multiples or ranges, proximal width1415.

In some embodiments, a depth1409of expandable body1408is 0.2-2, or 0.5-1 times or about 0.7 times, or lower, or higher, or intermediate multiples, or ranges of multiples of base width1407. In some embodiments, a depth1409of expandable body1408is 0.1-5, or 0.2-1 times or about 0.6 times, or lower, or higher, or intermediate multiples, or ranges of multiples of base width1407.

In some embodiments, expandable body1408is symmetrical in direction/s perpendicular to a proximal-distal direction. For example, a lumen defined by walls1410being circular along a length1409of the walls. In some embodiments, expandable body1408has a truncated cone shape (where the point of the cone is truncated).

In some embodiments, a holder1406(including one or more feature as illustrated in and/or described regarding holder1306FIGS.13A-B). Where central positioning of holder1406(e.g. as described regarding holder1306FIGS.13A-B) is, in some embodiments, with respect to cross sections of base1416and/or top1440and/or walls1410.

In some embodiments, holder1406is elongated. In some embodiments, top1440includes a top opening1476. In some embodiments, a source (not illustrated) is attached to holder1406by accessing holder1406through opening1476. In some embodiments, a push wire1422is connected to holder1406, at a proximal end of holder1406.

In some embodiments base1416and/or base recessed portion1460and/or connection of base1416to holder1406e.g. by connector1366include one or more feature as illustrated in and/or described regarding base1316and/or base recessed portion1360and/or connection of base1316to holder1306e.g. by connector1366respectively ofFIGS.13A-B.

Optionally, in some embodiments, top1440is attached to holder1306(not illustrated inFIGS.13A-B). In some embodiments, top1440is held together with base portion1466onto holder1406by connector1466. Alternatively or additionally, in some embodiments, a second connector (e.g. a second ring) connects top1440to holder1406.

Referring now toFIG.14C, in some embodiments, holder1406protrudes from recessed base portion1460.

In some embodiments, recession of connector1468(or any of elements1204,1368,1568,1766) is to a depth1469which is, in some embodiments, 0.1-5 mm, or 0.1-2 mm, or 0.1-1 mm, or lower or higher or intermediate depths or ranges. Where the term connector is, at least, in this paragraph and the paragraph below this paragraph, in some embodiments, used to refer to element/s of the device which connect material (e.g. mesh material of the device) together and/or to element/s which are rigid e.g. in comparison to material of the body of the device (e.g. mesh).

In some embodiments, material of the device is recessed further than a depth of the connector1468and then curves to meet the connector1468, the maximal depth of recession of the material being e.g. from a surface of a base of the device being, in some embodiments, 0.1-10 mm, or 0.5-5 mm, or 1-5 mm, or lower or higher or intermediate distances or ranges.

FIG.15Ais a simplified schematic sectional view of an expandable device1502, according to some embodiments of the invention.

FIGS.15B-Care simplified schematics of an expandable device1502, according to some embodiments of the invention.

In some embodiments,FIG.15AandFIGS.15B-Cillustrate the same expandable device1502.

In an exemplary embodiment, an expandable device1502includes walls1510, a base1516, a partially open distal end1518, and a centrally positioned holder1506.

Where, in some embodiments, expandable body1508walls1510have a shape including one or more feature as illustrated for and/or described regarding walls1410FIGS.14A-C. For example, expandable body1508, in some embodiments, has a truncated cone shape.

Where, in some embodiments, base1516includes one or more feature as illustrated in and/or described regarding base1316of expandable device1302FIGS.13A-B. For example where recessed portion1560and/or connecting portion1566correspond to recessed portion1360and/or portion1366.

Where, in some embodiments, partially open distal end1518of expandable device1502includes one or more feature as illustrated in and/or described regarding partially open distal end1318of expandable device1302FIGS.13A-B.

Where, in some embodiments, holder1506includes one or more feature illustrated in and/or described regarding holder1306FIGS.13A-Cand/or regarding position of holder1406FIG.14A(e.g. with respect to expandable body1408portion/s).

In some embodiments, expandable device1502includes a support1562which extends proximally from (and is optionally attached to) top1540, support1562extending towards base1516, and closely following (and/or in contact with) walls1510. In some embodiments, support1562extends to and closely follows (and or is in contact with) a portion of base1516, providing a double layered base region1578. In some embodiments, support1562closely follows (e.g. is at most 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 lower or higher or intermediate distances or ranges away from walls1510and/or base1516) and/or is in contact with surfaces of walls1510and/or base1578.

In some embodiments, support1562is recessed within walls1510(e.g. as illustrated inFIG.15A). Within walls1510supports walls1510and/or base1516. Alternatively, in some embodiments, support1562is disposed externally to walls1510and/or is proximal of base1516.

In some embodiments, support1562ends1578at an external region of base1516. A potential advantage being reduced screening of radioactive emissions from the source connected to holder1516by the double layering provided by support1562. In some embodiments, support1562ending before a central region of base1516is as mechanical support and/or reduced porosity is provided by denser wire distribution of base1516at central regions of the device e.g. associated with properties of expanding mesh structures.

Optionally, in some embodiments, support1562extends centrally e.g. along base recessed portion1560and is connected to holder1506.

FIG.16Ais a simplified schematic sectional view of an expandable device1602, according to some embodiments of the invention.

FIG.16Bis a simplified schematic view of an expandable device1602, according to some embodiments of the invention.

In some embodiments,FIG.16AandFIG.16Billustrate the same expandable device1602.

In an exemplary embodiment, an expandable device1602includes walls1610, a base1616, a centrally positioned holder1606, a partially closed top1640and a support1662.

Where, in some embodiments, walls1610have a shape including one or more feature as illustrated for and/or described regarding walls1310FIGS.13A-B.

Where, in some embodiments, base1616including one or more feature as illustrated in and/or described regarding base1316FIGS.13A-B.

In some embodiments, a source1604is attached to holder1606. Where one or more feature of the attachment and/or source is as illustrations referred to in and/or described in the sections of this document entitled “ ”. In an exemplary embodiment, source1604is a rhodium strip which is irradiated with Pd-103. In some embodiments, source1604is attached to holder1606by winding the strip onto the holder. Alternatively or additionally, source1604is provided as a coil and is then fitted onto holder1606e.g. with an interference fit associated with sizing of the holder1606and/or source1604.

In some embodiments, support walls1662do not extend to base1616. In some embodiments, support1662does not extend to a proximal portion of walls1610. A potential advantage being reduced screening of radioactive emissions from source1604by support1662in a direction towards aneurysm opening.

Optionally, in some embodiments, expandable device1602includes one or more distal support1682. In some embodiments, distal support1682is configured to hold expanding device1602in position within an aneurysm, for example holding device1602in position blocking an opening to the aneurysm. In some embodiments, distal support1682is an expandable structure which expands distally, for example, to contact and/or apply pressure to a top of the aneurysm. In some embodiments, an induced reactive force to the pressure, from the aneurysm on the device pushes the device into close contact with the aneurysm opening. In an exemplary embodiment, distal support1682is a spring. In some embodiments, distal support1682is connected to holder1606. Alternatively or additionally, in some embodiments, distal support is attached to one or more of base1616, walls1610and top1640.

In some embodiments, in a collapsed configuration (e.g. of distal support1682and/or of expandable device1602) distal support1682is recessed within walls1610.

In some embodiments, the expandable devices illustrated inFIGS.1,4A-H,5-10,11,12A-F,13A-C,14A-C,15A-C,17A-B,18include a distal support e.g. including feature/s as illustrated in and/or described regarding distal support1682FIG.16A-B.

FIG.17Ais a simplified schematic of an expandable device1702, according to some embodiments of the invention.

FIG.17Bis a simplified schematic sectional view of an expandable device1702, according to some embodiments of the invention.

In some embodiments,FIG.17AandFIG.17Billustrate the same expandable device1702.

Device1702, in some embodiments, is described with respect to description in other portion/s of this document as having walls1710and a base1716to which a holder is attached1706and a proximally positioned support structure including support walls1786and a support base1784. Where a push wire1722is attached to the support structure1738.

Alternatively, in some embodiments, device1702is described with respect to description in other portion/s of this document as having a base1784, a recessed portion1788of base1784to which push wire1722is attached. Where base1784is connected to walls1786which are closed by a top1710to which holder1706is connected.

Where, for example, recessed base1788includes one or more feature as illustrated in and/or described regarding1360FIGS.14A-B.

Where, for example, a shape of walls1786includes one or more feature as illustrated in and/or described regarding walls1410FIGS.14A-C.

Where, for example, recessed top1710includes one or more feature as illustrated in and/or described regarding1362FIGS.13A-B.

FIG.17Billustrates an embodiment, where holder1706is not directly connected to push-wire1722and/or proximal portion/s1784,1788potentially increasing flexibility of device1702e.g. during delivery through tortuous vasculature and/or increasing ability of device1702to conform to a shape of an aneurysm.

In some embodiments, holder1706and push wire connector1774are a connected single piece (e.g. including one or more feature as illustrated in and/or described regarding holder1306FIGS.13A-Band/or holder1406FIGS.14A-Cand/or holder150615A-C and/or holder160616A-B).

FIG.18is a simplified schematic cross sectional view of an expandable device1802, according to some embodiments of the invention.

In some embodiments, expandable device1802includes walls1810, a base1816and a support including support walls1886and a support base1184where the support extends around walls1810and base1816. The support, for example, including one or more features as described and/or illustrated regarding support1738FIG.17B.

In some embodiments, support walls1886are tubular in shape e.g. cylindrical and/or where the expandable body1808has rotational symmetry about central longitudinal axis1899. In some embodiments, a shape of walls1886includes one or more feature as described and/or illustrated regarding walls1310FIG.13A-B.

In some embodiments, a push-wire (not illustrated) is connected to a holder1806. Extending, in some embodiments, through opening1648. Alternatively, in some embodiments, the push wire extends from holder1806in an opposite direction, connected to and/or passing through a recessed base support portion1888.

In some embodiments, holder1806is attached to base1816by connector1866. Where, in some embodiments, connector1866is attached to base1816by one or more of crimping, welding and quenching and in an exemplary embodiments, is attached by quenching.

In some embodiments, holder1806hosts one or more radioactive source (not illustrated). In some embodiments, holder1806includes PEEK and/or cyanoacrylate and/or includes one or more feature as illustrated and/or described regarding holder/s elsewhere in this document.

Exemplary Materials

Exemplary Expandable Body Materials

In some embodiments, an expandable body of an expandable device is formed from mesh e.g. a mesh constructed of wires.

In some embodiments, porosity of one or more portion of the expandable device body, in an expanded conjuration (e.g. relaxed expanded, and/or expanded within an aneurysm) is 5-90%, or 10-90%, or 10-80%, or 20-80%, or 30-80%, or 20-70%, or lower or higher or intermediate ranges or percentages.

In some embodiments, pore density of one or more portion of the expandable device body, in an expanded conjuration (e.g. relaxed expanded, and/or expanded within an aneurysm) is 1-500, or 5-400 pores/mm2.

In some embodiments, at least a portion of the wires are formed from nitinol. In some embodiments, at least a portion of the wires are nitinol with an additional material (also herein termed “composite wires”) where exemplary additional materials include platinum and tantalum. For example, in some embodiments, wires include nitinol and a core of a different material (e.g. platinum and/or tantalum). In some embodiments, wires including nitinol and an additional material are 50-80% nitinol and 20-50% the additional material (by weight and/or volume). For example, in some embodiments, wires of the mesh include DFT® wire (Drawn Filled Tubing) from Fort Wayne Metals Research Products Corp.

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

In some embodiments, a single layer of mesh forming at least a portion of an expandable device includes 72-288 wires in the layer. In some embodiments, a multi-layer mesh (e.g. double layer mesh) forming at least a portion of an expandable device has 64-96 wires in each layer. In an exemplary embodiment, mesh is of a ½ type woven mesh. Where, in some embodiments, wires in one direction pass under two wires and then over two wires in the other direction. Other types of mesh, for example, 1/1, are envisioned and encompassed.

In some embodiments, devices including more than one layer (e.g.FIG.16A-Blayers1610,1662) close mesh layers act to increase wire numbers of the mesh. For example, in some embodiments, a single layer mesh has 64-96 wires. In some embodiments, close stacking of mesh layers acts to double mesh density e.g. for 64-96 wire layers, to an effective 128-192 wire layer.

Exemplary Connector Materials

Exemplary Sources and Exemplary Source Attachment

In many embodiments, a source is attached to a holder. In some embodiments, one or more property of holders in this section includes feature/s as described and/or illustrated regarding exemplary holders referred to within this document e.g. holder1106FIG.11and/or holder1206FIGS.12A-Hand/or holder1606FIGS.16A-B.

FIG.19Ais a simplified schematic of a source holder1906, according to some embodiments of the invention.

FIG.19Bis a simplified schematic of a radioactive source1904, according to some embodiments of the invention.

FIG.19Cis a simplified schematic of a radioactive source1904connected to a source holder1906, according to some embodiments of the invention.

In some embodiments,FIG.19Cillustrates source holder1906ofFIG.19Aand source1904ofFIG.19B.

Referring now toFIG.19Bwhich illustrates an exemplary source1904. In some embodiments, source1904(e.g. for device/s described in this document) has a body including a first material, which has been treated with radioactive material.

In some embodiments, a shape of source body1904is elongate (e.g. as illustrated inFIG.19A-C) in one or more direction. In some embodiments, source body/ies1904are spherical, or rod-shaped, or are coils (e.g. as described later within this section).

In some embodiments, the body is treated with one or more radioisotope (e.g. to become a source) e.g. Pd-103 and/or I-125. Where treating, for example, includes coating the body in a material containing the radioisotope and/or performing ion implantation, and/or radioactive activation via proton and/or neutron bombardment.

In an exemplary embodiment, the body includes (e.g. is formed from) rhodium. Where, in some embodiments, the rhodium has been treated (e.g. by proton bombardment e.g. in a cyclotron) to include radioactive Pd-103 isotopes.

In some embodiments, the source includes an encapsulated seed.

In some embodiments, the source includes a commercially available brachytherapy seed e.g. ISOAID Advantage™ JAI-125A, ISOAID Advantage™ IAPd-103A.

In some embodiments, the source includes a seed (optionally encapsulated) which is 0.05-2 mm, or 0.1 mm-1 mm, or lower or higher or intermediate dimensions or ranges, in at least one dimension, e.g. 0.05-2 mm, 0.1-1 mm in two dimensions or lower or higher or intermediate dimensions or ranges e.g. 0.05-2 mm, 0.1-1 mm or lower or higher or intermediate dimensions or ranges in all three dimensions.

In some embodiments, emissions from source for an expandable device are selected based on a size of an aneurysm to be treated, a shielding of the expandable device when the device is within the aneurysm to be treated and a position of the source with respect to the device and/or with respect to the aneurysm, when the device is in position.

For example, referring devices with width of 5 mm, 7 mm, 9 mm, 11 mm and 14 mm. In some embodiments, a source length for exemplary devices, is selected based on device dimension/s. Where, in some embodiments, one or more source characteristic remains the same (e.g. cross sectional dimension, radiation per volume and/or surface area of source). Where, for example, in some embodiments, a kit including a variety of sizes of device has sources scaled (e.g. by length) to be proportional to one or more dimension of the device e.g. in a relaxed expanded configuration and/or in expanded configurations with aneurysms.

For example, in some embodiments, one or more dimension of a device e.g. device expanded width and/or length and/or depth is 1-20, or 1-10, or 2-10, or lower or higher or intermediate times a central longitudinal axis length of the source.

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

In some embodiments, source holder1906includes a lumen1964configured to receive one or more source. In some embodiments, holder1906includes arms1936(e.g. including one or more feature illustrated and/or described regarding arms1136FIG.11). In some embodiments, source holder1906includes openings1937in the material of the holder potentially allowing escape of radiation un-attenuated by holder material from these openings.

In some embodiments, holder1906includes radiation blocking material, for one or more region of the holder. Potentially enabling control of directionality of radiation. For example, in some embodiments, radiation is screened in a direction towards optical nerve/s.

Referring now toFIG.19Cin some embodiments, source1904remains within holder1906at one or more end of holder by size and/or shape matching between the holder lumen1964and source1904e.g. holder walls are stretched during insertion of source1904into lumen1964. Alternatively or additionally, holder is closed at one or both end e.g. by cap/s and/or deformed to reduce lumen1964size potentially preventing exit of the source from the holder.

In some embodiments, source1904has a shorter length than holder lumen1964(e.g. as illustrated inFIGS.19A-B). In some embodiments, a position of source1904along a length of holder1906is selected e.g. before insertion of the device into a subject.

FIG.20Ais a simplified schematic of a source holder2006, according to some embodiments of the invention.

FIG.20Bis a simplified schematic of a radioactive source2004, according to some embodiments of the invention.

FIG.20Cis a simplified schematic of a radioactive source2004connected to a source holder2006, according to some embodiments of the invention.

In some embodiments, source2004is attached to holder2006externally. In an exemplary embodiment, source2004is an elongated element which is disposed by being wrapped around holder2006. In some embodiments, source2004is a coil e.g. wire as illustrated inFIG.20Bwhich is pushed onto support2006. In some embodiments, inner dimension/s of source2004(and/or source2104) are smaller than outer dimension/s of support2006and source is deformed (elastically and/or plastically) to fit onto support2006. Reactive force, in some embodiments, acting to hold source2004(and/or source2104) in position on support2006. In some embodiments, more than one source is attached to support2006e.g. in this way.

For example, including one or more feature as illustrated in and/or described regardingFIGS.29A-B.

FIG.21is a simplified schematic of a source2104, according to some embodiments of the invention. In some embodiments, source is a tape coil2104. In some embodiments, source2104is connected to a support e.g. including one or more feature illustrated and/or described regarding attachment of source2024to support2006FIGS.20A-C. In some embodiments, tape coil2104and/or wire coil2004sources are attached to a holder by being inserted into a lumen of the holder and, in some embodiments, held within the lumen by a cap and/or distortion of the lumen.

FIG.22Ais a simplified schematic of a radioactive source2204, a source holder2406and a source holder cap2234, according to some embodiments of the invention.

FIG.22Bis a simplified schematic of a radioactive source2204connected to a source holder2206, according to some embodiments of the invention.

In some embodiments, source2204is held within a holder lumen2264by cap2234. Where, in an exemplary embodiments, cap2234fixes to holder2206by screwing where cap2234and/or holder2206includes threading2297. Alternatively, or additionally, in some embodiments, cap2234is glued into position. Alternatively or additionally in some embodiments, cap2234and/or sized and/or shaped to have a portion insertable into lumen2264but difficult to remove e.g. having an interference fit with holder2206. In some embodiments, cap2234is closed and/or closes lumen2264. Alternatively, in some embodiments, cap includes one or more opening sized to be too small to allow passage of source2204.

Optionally, in some embodiments, element2204as illustrated inFIGS.22A-Bis a second holder, where a source is attached externally to element2204, where both element2204and a source (e.g. wrapped around, e.g. a coil source) coupled to element2204are held within lumen2264.

FIGS.23-26, in some embodiments, illustrate exemplary positions for a radioactive source with respect to a holder and/or connector.

In some embodiments, like elements ofFIGS.23-26are indicated with like reference numerals, e.g. element2304corresponding to element2504. Where “like” is herein defined as sharing one or more feature as illustrated in the figure/s and/or described regarding the figures in the text of this application.

FIG.23is a simplified schematic of a portion of an expandable device, according to some embodiments of the invention.

In some embodiments, a portion of an expandable body2308of an expandable device is held (e.g. closing a base or top) by a connector2366. Where, in some embodiments, connector2366has a ring shape. In some embodiments, connector2366is attached by one or more of crimping, welding, quenching. In some embodiments, a holder2306is attached to expandable body2308by connector2366, for example where (e.g. as illustrated inFIG.23) expandable body2308is disposed between holder2306and connector2366. Optionally, in some embodiments, connector includes radiopaque material.

Optionally, in some embodiments, holder2306provides connection of the expandable device to a push-wire2322. In some embodiments, connection is via a detachment region2392.

Where, in some embodiments, detachment region2392is configured to be one or more of electrolytically and electrothermally weakened to release a proximal portion of push-wire2322from the expandable device. In some embodiments, detachment region2392includes a mechanical attachment which, in some embodiments is released for removal of push-wire2322. Where, in some embodiments, mechanical attachment includes a screw attachment where push-wire is rotated to detach. In some embodiments, mechanical detachment includes a pull and/or push wire activated release, where the device includes an additional control wire e.g. extending through the catheter for control by a user.

In some embodiments, holder2306provides electrical insulation between detachment region2392and/or push-wire2322and expandable body2308(and/or other regions of the device). A potential benefit being the ability to detach the push-wire using electrical stimulation, without providing the stimulation to the rest of the device.

In some embodiments, a source2304is attached to holder2306e.g. externally e.g. including one or more feature as described regarding sources2004,2104and holder2006FIGS.20A-CandFIG.21. Alternatively or additionally, a source is attached to holder2306by being inserted at least partially into a lumen of the holder (e.g. as described and/or illustrated regarding holder1106FIG.11and/or holder1906and/or source1904FIGS.19A-C).

In some embodiments, source2304is attached to a portion of holder2306distal of connection of the holder to expandable body2308e.g. potentially positioning source2304in a central region of the device e.g. as described elsewhere in this document.

In some embodiments, connector2366includes radiopaque material meaning that potentially, it blocks radiation emitted by source2304distally. In some embodiments, the source is positioned proximally and/or externally to connector2366.

FIG.24is a simplified schematic of a portion of an expandable device, according to some embodiments of the invention.

In some embodiments,FIG.24illustrates an embodiment where a source2404is attached externally to a holder2406, between holder2406and a connector2466and/or mesh of an expandable body2408. Where connector2466includes radiopaque and/or radiation attenuating material, potentially position of source2404within connector2466reduces radiation emanated (and received by tissue) in a direction perpendicular to the proximal-distal direction (where push-wire2422is disposed at a proximal end of the illustration ofFIG.24and extends in a distal direction) and/or in an axial direction (with respect to a ring shaped connector2466).

FIG.25is a simplified schematic of a portion of an expandable device, according to some embodiments of the invention.

In some embodiments a source2504is attached externally to a connector2466. Potentially reducing attenuation of radiation emitted by source2504by connector e.g. as opposed to the configuration illustrated inFIG.24.

FIG.26is a simplified schematic of a portion of an expandable device, according to some embodiments of the invention.

In some embodiments, a source2604is attached proximally of a connector2666. If connector2466includes radiation attenuating material, this proximal attachment of source means that radiation directed proximally e.g. towards a neck of an aneurysm is not attenuated by connector2666.

Exemplary Multiple Sources and/or Multiple Source Devices

FIG.27is a simplified schematic cross sectional view of an expandable device2702, according to some embodiments of the invention.

In some embodiments, expandable device2702includes more than one source2704a,2704b. In some embodiments, one or more source2704ais selected and/or positioned for irradiation of an aneurysm sac and/or internal volume. In some embodiments, one or more source2704bis selected for irradiation of an aneurysm neck region. In some embodiments, more than one source2704a,2704bis hosted by a single holder2706.

FIG.28is a simplified schematic cross sectional view of an expandable device2802, according to some embodiments of the invention.

In some embodiments, expandable device2802includes a plurality of sources2804a-d. In some embodiments, one or more expandable element2863is configured to position a source2804cattached to expandable element2863e.g. within a volume defined by expandable body2808. In some embodiments, each source2804a-dis connected to holder2806by an individual expandable element (e.g. as illustrated inFIG.28.

Exemplary Shielding

For example, as described elsewhere in this document e.g. with respect to2246connector ofFIGS.22A-Bbeing radiation blocking. In some embodiments, a source is shielded from irradiating in one or more direction. Where, in some embodiments, shielding includes attenuating the emitted radiation to generate a reduced dose and/or dose rate in one or more direction. Where, in some embodiments, shielding includes blocking emitted radiation.

In some embodiments, radiopaque materials are used for shielding e.g. connector2246including platinum.

In some embodiments, doped PMMA is used for shielding. For example, including one or more feature as described and/or illustrated 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 herein incorporated by reference in its entirety.

Exemplary Radiation Levels

In some embodiments, total dose is measured using one or more technique as known in the art of radioactive source measurement. For example, total dose being measured from source, by using one or more of source isotope half-life time, known activity, and measurement time e.g. using a TG-43 algorithm as known in the art of dose calculation for radioactive sources.

In some embodiments, a neck of the aneurysm receives a desired dose e.g. of 10-40 Gy (and/or doses as described elsewhere in this document).

In some embodiments, the desired dose received is related to one or more of a plurality of device characteristics. For example, where, for a given source, the dose received by the neck of the aneurysm is related to a distance of the source from the neck and strength of any shielding between the source and the neck. Where, shielding in some embodiments, is provided by material of the expandable body and/or one or more additional element (e.g. marker, connector).

Where, in some embodiments, possible distances of the neck from the source are defined by a size of the aneurysm and/or maximal radiation dose to be tolerated by tissue outside the aneurysm. Where the radiation dose received by tissue outside the aneurysm is also affected by any shielding between the source and the tissue (e.g. as provided by a body of the expandable device therebetween). In some embodiments, the neck is 1-10 mm from the source.

In some embodiments, radioactive source/s for devices and/or exemplary radiation doses and/or dose rate/s for treatment (e.g. of aneurysm) as described within this document include one or more feature as described and/or illustrated regarding seed/s and/or sources within US Patent Publication No. US2020/0078602 which is herein incorporated by reference in its entirety.

In some embodiments, one or more portion of the expandable body absorbs 10-90%, or 20-80%, or 30-70%, or lower or higher or intermediate percentages or ranges. In some embodiments, one or more portion of the expandable body absorbs 20-80% of emitted radiation from a source incident on the expandable body, or lower or higher or intermediate percentages of radiation emitted from the source. For exemplary doses listed below, if, in some embodiments, the mesh is disposed at less that 5 mm away from an outer surface of the source, the dose levels listed are reduced by 20-80% at 5 mm and 10 mm the reduction, in some embodiments, reflecting absorption by the expandable body of the device. If the mesh is disposed between 5 mm and 10 mm then the dose levels listed at 10 mm, in some embodiments, are reduced by 20-80%.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

In some embodiments, radiation source/s of an expandable device (e.g. expandable devices as described within this document) are configured to irradiate a region of the aneurysm sac and/or neck, while minimally radiating tissue outside the aneurysm. For example, where, the aneurysm has an average (and/or maximum) dimension of 5 mm, in some embodiments, a radioactive dose at 5 mm from a source central axis is 15% of the dose at 1 mm from the source central axis. In some embodiments, a radioactive dose at 10 mm away from a source central axis, and/or a source outer surface is 0.5% of a dose 1 mm from the source.

In some embodiments, a radioactive source is 0.1-10 mm, or 1-5 mm long, or lower or higher or intermediate ranges or lengths. In some embodiments, the source is elongate. In some embodiments, a width (e.g. maximal and/or average cross sectional dimension e.g. taken perpendicular to a length of the source) is 0.1-1 mm, or 0.15-0.5 mm wide or higher or lower or intermediate ranges or widths. In some embodiments, a radioactive source is 0.1-10 mm long and 0.1-1 mm wide. In some embodiments, a radioactive source is 1-5 mm long and 0.15-0.5 mm wide.

In some embodiments, the radioactive source includes Iodine-125 (I-125). For example, a titanium encapsulated I-125 seed. Where, in some embodiments, the seed is 0.5-1 mm in average and/or maximum cross sectional dimension (e.g. diameter) and/or 5-10 mm in length. In some embodiments, the radioactive source is a commercially available Iodine-125 brachytherapy seed, produced for use in brain brachytherapy.

In some embodiments, a radioactive dose at 5 mm from a 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.

In some embodiments, a radioactive source includes Palladium-103. Where, in some embodiments, a radioactive dose at 10 mm away from a source outer surface is 0.5% of a dose 1 mm from the source.

In some embodiments, energies of the gamma isotopes are 20-30 KeV. In some embodiments 4-15, or 10-15 mm, or lower or higher or intermediate distances or ranges away from the source all of the radiation is absorbed. In some embodiments, a radioactive dose received by tissue at 4-15, or 10-15 mm, or lower or higher or intermediate distances or ranges away from an outer surface of the source is less than 1% of the total dose received by tissue.

FIG.38shows tables illustrating exemplary dose rates, according to some embodiments of the invention.

In some embodiments, exemplary doses for two exemplary isotopes are illustrated, I-125 and Pd-103. Where, in some embodiments, each column, for each table, illustrates three exemplary embodiments, of different dose rates for three different distances from a surface of the exemplary source. In some embodiments, for each time duration after implantation, values of a column related to values of a similarly positioned column for the different time duration. For example, referring to the first example of the first column of the first table, an I-125 source, at one day post implantation irradiates at 0-1 mm 50 mGy/hour, at 5 mm 7.5 mGy/hour and, at 10 mm 1 mGy/hour and, in some embodiments, the same source irradiates at 30 days post implantation irradiates at 0-1 mm 37.5 mGy/hour, at 5 mm 5.625 mGy/hour and, at 10 mm, 0.75 mGy/hour. In some embodiments, all values within the table and/or within this section of the document are approximate values, understood to be +/−20% of the stated values.

Additional Exemplary Embodiments

Patent document EP3136986 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in EP3136986.

FIG.29Ais a simplified schematic of an expandable device2902, according to some embodiments of the invention.

FIG.29Bis a simplified schematic cross section of an expandable device2902within an aneurysm, according to some embodiments of the invention.

In some embodiments, expandable device2902includes an expandable body2908which in some embodiments, includes mesh e.g. is formed from mesh. Where, in some embodiments, an open end of a tubular mesh structure is closed by a connector2966. In some embodiments, connector2966attaches a holder2906to expandable body2908. In some embodiments, connector2966is 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, holder2906hosts one or more radioactive source2904. Alternatively, or additionally, in some embodiments, source2904is directly attached to expandable body2098. In some embodiments, expandable body2908includes walls2910where, in some embodiments, walls2910conform, at least partially, to a shape of aneurysm2926inner walls. In some embodiments, expandable body2908includes a base portion2916(e.g. formed mesh) where, for example, walls2910are connected by base2916. Where, in some embodiments, connector2966is connected to base portion2916. In some embodiments, expansion of expandable body2908(e.g. elastic) in a direction away from connector and/or base holds device2902in position within aneurysm2926, covering (at least partially) an opening of aneurysm2926.

In some embodiments, device2902is symmetrical (e.g. in a relaxed expanded configuration) about one or more axis e.g. where a 3D geometry of the device, in some embodiments, is formed by rotating the cross section as illustrated inFIG.29Aaround a central proximal-distal axis2999.

Patent document US20190269414 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in US20190269414.

FIG.30Ais a simplified schematic of an expandable device3002, according to some embodiments of the invention.

FIG.30Bis a simplified schematic cross section of an expandable device3002within an aneurysm3026, according to some embodiments of the invention.

In some embodiments, device3002includes a plurality of expandable portions3008connected to each other by connectors3066. In some embodiments, one or more of connectors3066FIG.30A3066a-dFIG.30B(e.g. a most proximal of connectors3066e.g.3066dFIG.30B) are connected to a delivery apparatus (e.g. including a push-wire), which, in some embodiments is detached after deployment of the device. Where, in some embodiments, expandable portions include mesh e.g. are formed of mesh. In some embodiments, the mesh for each expandable portion has the same properties. Alternatively, in some embodiments, mesh of one or more of the expandable portions3008have different properties e.g. relaxed configuration dimension/s and/or porosity and/or mesh material. In some embodiments, individual expandable portions conform separately to a shape of aneurysm3026. For example, each expandable portion3008changing length and/or width to fit aneurysm. In some embodiments, one or more portion of expandable device3002is connected to a source (e.g. exemplary sources and/or source attachment as described elsewhere in this document). Where, in some embodiments, one or more connector3066FIG.30A,3066a-dFIG.30Bis a radiation source and/or hosts one or more a radiation source and/or is attached to a holder which hosts one or more radiation source. In some embodiments, central connectors are and/or host radiation source's e.g. connector3066band/or connector3066c. In some embodiments, only connector/s located within a central region of device3002are and/or host sources.

Patent document U.S. Pat. No. 9,629,635 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in U.S. Pat. No. 9,629,635.

FIG.31is a simplified schematic cross section of an expandable device3102within an aneurysm3126, according to some embodiments of the invention.

In some embodiments, expandable device3102includes an expandable body3108which is connected to a cover3116. Where, in some embodiments, one or both of body2108and cover3116include (e.g. are formed of) mesh. In some embodiments, expandable body3108is expanded within aneurysm3126where, in some embodiments, sizing and/or relaxation force of the expandable body on the aneurysm walls holds body3108in position within aneurysm3126. In some embodiments, cover3116is sized and/or shaped to cover an opening of aneurysm3126. In some embodiments, cover3116is disposed outside aneurysm opening and/or is, when the device is correctly positioned e.g. as illustrated inFIG.31elastically relaxed. Alternatively, in some embodiments, cover3116is configured to at least partially conform to a shape of the blood vessel at a region of the aneurysm opening. Where, in some embodiments, cover as illustrated inFIG.31is applying expanding force on portion/s of the vessel wall with which it is in contact. In some embodiments, tension between connection of the cover and expandable body3108holds the cover against vessel tissue at the aneurysm opening, in positon. In some embodiments, device3102is symmetrical (e.g. in a relaxed expanded configuration) about one or more axis e.g. where a 3D geometry of the device, in some embodiments, is formed by rotating the cross section as illustrated inFIG.31around a central proximal-distal axis3199. In some embodiments, device3102includes one or more connector3166. Where, in some embodiments, connector/s3166(e.g. a most proximal of connector/s3166) close open region/s of tubular mesh and/or hold a shape (e.g. including folded portion/s) of device3102in position. In some embodiments, connector/s3166are 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 one or more of connector/s is a radioactive source (e.g. as described within this document) and/or hosts a radioactive source (e.g. externally and/or within a lumen) and/or is attached to a holder which hosts one or more radioactive source. In some embodiments, only connector/s located within a central region of device3102are and/or host sources.

Patent document US20170367708 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in US20170367708.

FIG.32is a simplified schematic view of an expandable device within an aneurysm, according to some embodiments of the invention.

In some embodiments, device3202includes (e.g. is formed of) an elongated portion (e.g. wire) which, when in a relaxed configuration coils through space to delineate a shape of the device3202. In some embodiments, device3202includes a body3208and a cover3216where body and/or cover include one or more feature as illustrated in and/or described regarding cover3216and/or body3208. In some embodiments, device3216includes a connector3266. Where, in some embodiments, connector3266connects cover3216to body3208. In some embodiments, connector3266is 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, connector3266includes one or more radioactive source3204. Alternatively or additionally, in some embodiments, connector3266hosts one or more source3204. In some embodiments, connector3266is connected to a holder3206hosting source3204. In some embodiments, for example, where connector3266is radiopaque, a source is connected proximally to connector3266, optionally, by a holder.

Patent document US20180140305 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in US20180140305.

FIG.33is a simplified schematic view of an expandable device3302within an aneurysm3326, according to some embodiments of the invention.

In some embodiments, expandable device3302includes an outer body3308a. Where, in some embodiments, outer body3308aexpands to conform to a shape of aneurysm3326. In some embodiments, outer body3308aincludes (e.g. is formed of) mesh. Optionally, in some embodiments, device3302includes an inner body3308b. In some embodiments, inner body3308bis positioned to provide a double layer of mesh at an opening of aneurysm3326. In some embodiments, inner body3308bis attached to outer body3308be.g. to position inner body3308bat the aneurysm opening. In some embodiments, inner body3308bis delivered and/or expanded separately to outer body3308b.

In some embodiments, one or more portion of outer body3308aand/or of inner body3308bis a radioactive source. In an exemplary embodiment, inner body3308bincludes a radioactive source e.g. in some embodiments, mesh of inner body3308b(e.g. of the entire inner body3308b, in some embodiments) is a radioactive source. For example, as described elsewhere in this document, in some embodiments, a portion of a body of a radioactive device is itself a radioactive source e.g. at least a portion of a mesh e.g. in some embodiments is treated to become a radioactive source, the emissions of which are according to description of sources elsewhere in this document. In some embodiments, a portion of a mesh body is a radioactive source e.g. where treatment includes one or more feature of treatment's as described elsewhere in this document.

Patent document JP2019526324A (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in JP2019526324A and/or are attached to commercially available devices for treatment of LAA for example, device/s produced by Boston Scientific e.g. Watchman™.

FIG.34is a simplified schematic view of an expandable device3402within an aneurysm3426, according to some embodiments of the invention.

In some embodiments, an open ended device3402e.g. where positioning and/or maintaining of the device in position includes one or more feature as described regarding open ended device2902FIGS.29A-B. In some embodiments, device3402includes a support structure3440. In some embodiments, support structure3440is expandable e.g. elastically expandable. In some embodiments, support structure3440is formed from elongated element/s e.g. wires. In some embodiments, support structure is at least partially covered in a body3408. Where, in some embodiments, body3408includes (e.g. is formed of) mesh. Alternatively or additionally, in some embodiments, body3408includes a polymer layer. In some embodiments, at least portion of the body3408includes radioactive material, for example, being a source. Alternatively or additionally, in some embodiments, a source3404(or multiple sources) are attached to support3440and/or body3408directly and/or via a holder3406hosting source3404.

In some embodiments, device3402includes a distal support structure (not illustrated) including one or more feature of distal support structure1682as illustrated in and/or described regardingFIGS.16A-B.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to commercially available aneurysm treatment device/s produced by Medtronic e.g. ARTISSE™.

FIG.35is a simplified schematic cross section of an expandable device3502, according to some embodiments of the invention.

In some embodiments, device3502is symmetrical (e.g. in a relaxed expanded configuration) about one or more axis e.g. where a 3D geometry of the device, in some embodiments, is formed by rotating the cross section as illustrated inFIG.35around a central proximal-distal axis3599.

In some embodiments, device3502includes an expandable body3508which includes one or more feature as described and/or illustrated regarding expandable bodies elsewhere in this document. In some embodiments, expandable body3508includes walls3510(e.g. tubular walls3510) and a base3516. In some embodiments, expandable body3508includes (e.g. is formed of mesh). In some embodiments, expandable body3508includes a top3540where a mesh structure of the top is not open and/or not closed with a connector. Optionally, in some embodiments, mesh ends meeting at a central region of base3516are connected by a connector3566. In some embodiments, connector3566connects a detachable delivery apparatus (not illustrated) to device3502. In some embodiments, one or more radioactive source3504is connected to expandable body3508, for example, by connector3566directly and/or via a holder3506. Where, in some embodiments, holder3506includes one or more feature as illustrated in figures associated with of this document and/or described regarding holder/s, elsewhere in this document.

Patent document U.S. Pat. No. 9,629,635 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) are attached to device/s as described in U.S. Pat. No. 9,629,635 and/or are attached to commercially available devices for treatment of aneurysm for example, device/s produced by Terumo Group e.g. Woven EndoBridge® WEB™ SL and/or WEB™ SLS.

FIG.36is a simplified schematic cross section of an expandable device3602, according to some embodiments of the invention.

In some embodiments, device3602includes an expandable body3608having tubular walls3610where ends of the walls, proximally and distally are connected to form a base3616and a top3640respectively, by connectors3666aand3666brespectively. In some embodiments, device3602is symmetrical (e.g. in a relaxed expanded configuration) about one or more axis e.g. where a 3D geometry of the device, in some embodiments, is formed by rotating the cross section as illustrated inFIG.36around a central proximal-distal axis3699.

In some embodiments, proximal connector3666aconnects a detachable delivery apparatus (not illustrated) to device3602. In some embodiments, one or more radioactive source3604is connected to expandable body3608, for example, by one of connector/s3666a3666b(and in an exemplary embodiment, by proximal connector3666b) directly and/or via a holder3606. Where, in some embodiments, holder3606includes one or more feature as illustrated in figures associated with of this document and/or described regarding holder/s, elsewhere in this document.

Patent document U.S. Pat. No. 9,844,382 (which is herein incorporated by reference in its entirety) shows vascular deformity (e.g. aneurysm) treatment devices.

In some embodiments, exemplary source/s as described in this document (e.g. in the section titled “Exemplary radiation levels” and/or in the section titled “Exemplary sources and exemplary source attachment”) are attached (e.g. including one or more attachment method and/or structure as described in the section of this document titled “Exemplary sources and exemplary source attachment”) to structure/s as described in U.S. Pat. No. 9,844,382.

FIG.37is a simplified schematic cross section of an expandable device3702, according to some embodiments of the invention.

In some embodiments, expandable device3702is an elongate structure, including a mesh body3708. Where, in some embodiments, a body3708, which in some embodiments, has a tubular structure, is coiled into an aneurysm. In some embodiments, mesh body3708is expandable at a direction perpendicular to a central longitudinal axis of the device, at one or more region. Where, for example, in some embodiments, once within an aneurysm, expandable regions expand e.g. increasing a volume of the aneurysm which is enclosed by surfaces of the device. In some embodiments, one or more portion of the elongate structure includes a connector3766a,3766bwhich in some embodiments, hosts a source and/or is connected to a holder hosting a source. Alternatively or additionally, in some embodiments one or more source3704is connected to body3708along a length of the body. In embodiments, where a source is connected to one or both of connectors3766a,3766b, source3704is optional.

Additional Exemplary Methods

FIG.39Ais a flow chart of a method, according to some embodiments of the invention.

At3900, in some embodiments, a compressed device is delivered to a treatment site, e.g. to an aneurysm. Delivery, in some embodiments, including one or more feature of step208FIG.2.

In some embodiments, the device does not include radioactive source/s. For example, devices as described elsewhere in this document are used without attachment of a radioactive source. In some embodiments, the device does not include a holder for a radioactive source. Where, in some embodiments, holders as described elsewhere within this document are lacking and/or replaced by element/s offering the described mechanical feature/s.

In some embodiments, the device includes one or more feature of device102ofFIG.1without source104and/or holder106.

In some embodiments, the device includes one or more feature of device402ofFIGS.4A-Hwithout source404and/or holder406. For example, in some embodiments, device402without holder406, push-wire422is attached directly to body408e.g. as opposed to attached to holder406which provides attachment of the push-wire422to body408.

In some embodiments, the device includes one or more feature of device502ofFIG.5without source504and/or holder506.

In some embodiments, the device includes one or more feature of device602ofFIG.6without source604and/or holder606.

In some embodiments, the device includes one or more feature of device702ofFIG.7without source704and/or holder706.

In some embodiments, the device includes one or more feature of device802ofFIG.8without source804and/or holder806.

In some embodiments, the device includes one or more feature of device902ofFIG.9without source904and/or holder906.

In some embodiments, the device includes one or more feature of device1002ofFIG.10without source1004and/or holder1006.

In some embodiments, a device includes one or more feature of device1102ofFIG.11where no source is placed within lumen1146and/or where device1102lacks portion/s1136and/or1134. For example, connection to a push-wire being provided by portion/s replacing portion1136and/or portion1134. For example, in some embodiments, a device has shape and/or geometry and/or other body characteristic/s as described regarding body1108but with an attachment region including feature/s as described elsewhere in this document e.g. regarding one or more of attachment regions4011FIGS.40A-C,4111FIGS.41A-B,4211FIGS.42A-F,4311FIGS.43A-C,4411FIGS.44A-B,4511FIGS.45A-D,4611FIGS.46A-D,4711FIGS.47A-C,4811FIGS.48A-C,4911FIGS.49A-B,5011FIGS.50A-B.

In some embodiments, the device includes one or more feature of device1202ofFIGS.12A-He.g. without source1204(and/or holder1206).

In some embodiments, the device includes one or more feature of device1302(e.g. having shape and/or geometry and/or other characteristics of body1108) ofFIGS.13A-Cwithout a source and/or holder1306.

In some embodiments, the device includes one or more feature of device1402(e.g. having shape and/or geometry and/or other characteristics of body1408) ofFIG.14A-Cwithout a source and/or holder1406.

In some embodiments, the device includes one or more feature of device1502(e.g. having shape and/or geometry and/or other characteristics of body1508) ofFIGS.15A-Cwithout a source and/or holder1506.

In some embodiments, the device includes one or more feature of device1602(e.g. having shape and/or geometry and/or other characteristics of body1608) ofFIGS.16A-Bwithout source1604and/or holder1606.

In some embodiments, the device includes one or more feature of device1702(e.g. having shape and/or geometry and/or other characteristics of body1708) ofFIGS.17A-Bwithout a source and/or holder1706.

In some embodiments, the device includes one or more feature of device1802(e.g. having shape and/or geometry and/or other characteristics of a body of device1802ofFIG.18without a source and/or holder1806(device body e.g. including base1816and/or walls1810and/or support base1884and/or walls1886).

In some embodiments, the device includes one or more feature of device2702(e.g. having shape and/or geometry and/or other characteristics of body2708) ofFIG.27without source2704aand/or holder2706.

In some embodiments, the device includes one or more feature of device2802(e.g. having shape and/or geometry and/or other characteristics of body2808) ofFIG.28without sources2804a-dand/or holder2806.

At3902, in some embodiments, the device is deployed at the treatment site. For example, deployed into the aneurysm. Deployment, for example, including one or more feature of step210ofFIG.2.

FIG.51is a flowchart of a method, according to some embodiments of the invention.

At5100, optionally, a radioactive source is fitted onto a device. Fitting, for example, including one or more feature of step202FIG.2.

At5102, in some embodiments, a compressed device is delivered to a treatment region (e.g. to an aneurysm). For example, delivery including one or more feature as described regarding step3900FIG.39A.

In some embodiments, the device is compressed by inserting the device into a tubular structure e.g. crimping tube. For example, by threading the device through the crimping tube (e.g. using the push-wire) and then pulling the device into the crimping tube e.g. by pulling on the device push-wire.

At5104, in some embodiments the device is deployed within the treatment site (e.g. aneurysm). For example, deployment including one or more feature as described regarding step3902FIG.39A.

At5106, optionally, in some embodiments, one or more radioactive source is decoupled and/or coupled to the device.

For example, in some embodiments, once deployed, radioactive source/s are delivered to the treatment region and optionally coupled and/or attached to the deployed device. In some embodiments, after device deployment, portion/s of the device for hosting radioactive source's are selected e.g. based on their position with respect to treatment site anatomy. For example, in some embodiments, once deployed radioactive source/s are decoupled from the device e.g. and then are removed or repositioned. A potential benefit of coupling and/or decoupling after deployment being the ability to accurately position source's with respect to treatment site anatomy.

In some embodiments, after device deployment, a medical practitioner decides whether or not to couple or decouple radioactive source/s. For example, after conducting one or more measurement. For example, in some embodiments, flow measurement/s are collected after positioning of the device and, based on how the mechanical structure of the expanded device affects blood flow to the aneurysm, radioactive sources are coupled and/or decoupled. For example, where blood flow is sufficiently reduced mechanically, in some embodiments, no radioactive source is coupled, the device, in situ, in some embodiments, not including any radioactive sources.

At5108, in some embodiments, the device is decoupled from delivery apparatus e.g. from a push-wire. For example, including one or more feature of step212FIG.2.

At5110, in some embodiments, delivery apparatus (e.g. including the push-wire and a delivery catheter) is removed. For example, including one or more feature of step214FIG.2.

At5112, optionally, in some embodiments, a time period is allowed to elapse. For example, sufficient time to determine treatment efficacy of the device in situ. For example, the time period being 1 day to 6 months. In some embodiments, imaging and/or other measurement/s are performed to determine efficacy of treatment with the device (e.g. the patient is diagnosed using one or more feature of step200FIG.2). In some embodiments, based on the diagnosis, change/s to the device are selected. Where, in some embodiments, change/s include removal and/or addition of radioactive source/s.

At5114, optionally, in some embodiments, decouple and/or couple radioactive source/s to device. For example, as selected based on the diagnosis. In some embodiments, a delivery apparatus is positioned at the treatment site and interacts with the device to couple and/or decouple one or more radioactive source.

For example, referring toFIGS.11,19A-B, where the device includes container/s configured to house radioactive device/s coupled to the device, in some embodiments, a container is opened by the delivery apparatus to remove a radioactive source or to insert a radioactive source (in some embodiments, to insert an additional radioactive source).

In some embodiments, one or more radioactive source is attached to the device e.g. to a holder of the device and/or to a body of the device. For example, where, in some embodiments, a radioactive source is wrapped (or unwrapped) around a portion of the device (e.g. holder) and/or fixed onto a portion of the device (e.g. a coil radioactive source is pushed onto (or pulled off of) a portion of the device e.g. holder.)

Additional Exemplary Expandable Devices

FIG.39Bis a simplified cross sectional schematic of an intravascular device system3900, according to some embodiments of the invention.

In some embodiments, system3900includes one or more feature of system100FIG.1but lacking source104FIG.1and/or device3902includes one or more feature of device102ofFIG.1but lacking source104FIG.1.

In some embodiments, device3902includes a second body layer1363(also termed “support”).

FIG.39Cis a simplified cross sectional schematic of an intravascular device system3901, according to some embodiments of the invention.

In some embodiments, system3901includes one or more feature of system100FIG.1but lacking source104FIG.1and/or device3903includes one or more feature of device102ofFIG.1but lacking source104FIG.1.

In some embodiments, device3904includes a second body layer3965(also termed “support”).

In some embodiments, a device body3908is recessed e.g. at a base, a recessed portion3960including one or more feature of recessed portion1360FIGS.13A-B, and/or recessed portion1460FIGS.14A-C, and/or recessed portion1560FIGS.15A-C, and/or recessed portion1788FIGS.17A-B.

FIG.40Ais a simplified schematic cross sectional view of a device4002, according to some embodiments of the invention.

FIG.40Bis a simplified schematic cross sectional view of a portion4011of a device, according to some embodiments of the invention.

In some embodiments,FIG.40Bshows an enlarged view of connection region4011ofFIG.40A.

FIG.40Cis a simplified schematic cross sectional view of a portion4011of a device, according to some embodiments of the invention.

In some embodiments,FIG.40Cillustrates a cross section of portion4011taken along line AA ofFIG.40B.

In some embodiments, device4002includes one or more feature of device/s1202as illustrated and/or described regardingFIGS.12A-H. Where, in some embodiments, like numerals refer to corresponding features, e.g. feature1210corresponding to feature4010.

In some embodiments, device4002includes an expandable body4008. In some embodiments, body4008has a curved cup shape including wall regions4010and a base region4016.

In some embodiments, at least a portion of expandable body4008is constructed by using a tubular shaped material (e.g. mesh) where one of the ends of the tubular shape is narrowed and/or closed and/or is held together at a connection region4011. The tubular shape, in some embodiments, has a lower cross sectional area at an end of the device at the connection region4011than that at the distal ends of walls4010. In some embodiments, the tubular shape has reducing cross sectional area moving in a direction towards the connection region4011e.g. to form a flattened cup shape with an opening at connection region4011.

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 constricted (e.g. attached at attachment region) to form body4008and/or support4040. In some embodiments, folding and/or constriction changes porosity of the device and/or density of mesh in one or more portion of the device e.g. from that of the tubular structure from which the device is formed. For example, as illustrated inFIGS.41A-Bwhere mesh density increases (e.g. porosity decreases) towards a center of the device. In some embodiments, the device is elastically relaxed when in an open configuration as illustrated inFIGS.40A-Cand/orFIGS.41A-B. In some embodiments, elastic relaxation in the open shape configuration is produced using a tubular nitinol structure which is heat treated to have shape memory of the open configuration. For example, in some embodiments, a tubular mesh is inserted into and/or positioned on a mold and then heat treated to shape memory set at least a portion of the shape of the device to that of the mold. In some embodiments, shape of the device is set using a single mold and/or heat treatment. In some embodiments, a plurality of mold/s and/or heat treatments are used (e.g. sequentially) to shape the device. In some embodiments, device4002includes one or more support4040,4050. Where, in some embodiments, support4040,4050includes one or more additional layer of material (e.g. body material) which layer/s at least extend over (at least a portion of) a central region (e.g. at least a central 10%, e.g. central in at least one dimension) of the device. Where, in some embodiments, a central region of the device is at connection region4011.

In an exemplary embodiment, support4040,4050is formed from the same tube of material (e.g. mesh) as body4010. Support portions4040,4050being formed by folding of the tube one or more times e.g. twice as illustrated inFIG.40A.

In some embodiments, device4002optionally includes a holder4006and/or a optionally includes a connector4066and/or optionally includes bonding material4051.

In some embodiments, connection region4011(e.g. including one or more of holder4006, connector4066, and bonding material) provides one or more of connection of body end portion4009(e.g. as described above), connection of device4002to a delivery apparatus4022, connection of device4002to a holder4006, radiopaque marking (e.g. in some embodiments connector4066and/or holder4006include radiopaque material), and, optionally, hosting of radioactive source/s.

In some embodiments, of illustrated elements holder4006, connector4066, and bonding material4051, device4002includes only bonding material. Where, for example, end portion4009, and/or delivery apparatus4022are attached by bonding and/or welding only4051.

In some embodiments, along with bonding material4051, connector4066is present. For example, connector4066providing mechanical support to connection of end portion4009and/or radiopaque marking.

In some embodiments, device4002also includes a holder4006.

Optionally, in some embodiments, holder4006is disconnected from delivery apparatus4022during and/or after device deployment. In some embodiments, holder4006is a portion of the delivery apparatus and, in some embodiments, is removed from device4002during and/or after device deployment.

In some embodiments, connection of body4008at connection region4011is by bonding and/or welding another portion to a portion of body4008end. For example, by bonding one portion to body4008end. For example, by bonding one of holder4006and connector4066to body e.g. where, the other of holder4006and connector4066is not connected (e.g. is removable) and/or is not present.

Referring now toFIGS.40B-C, in some embodiments, connection is by holding a body end portion4009between two other portions (which end portion4009, in some embodiments, is an end portion of the tubular material extending from support4040). For example, in some embodiments, end portion4009is held between a connector4066and a holder4006, optionally with bonding material4051disposed between the connector and holder. In some embodiments, for example, where body4008material is porous (e.g. is a mesh), end portion4009material is immersed in bonding material4051e.g. as illustrated inFIG.40B. In some embodiments, bonding material4051is one of disposed between connector4066and body portion4051and disposed between body4008and holder4006.

In some embodiments, for example, as described elsewhere in this document, body portion/s of device4002are connected and/or closed at connection region4011. In some embodiments, holder4006(e.g. as described elsewhere in this document) holds one or more radioactive source and/or provides connection to delivery and/or positioning apparatus4122.

In some embodiments, body4008is bonded to holder4006and/or to a connector4066e.g. by bonding material4051. In some embodiments, connector4066provides mechanical strength to connection of body4008material. Alternatively or additionally, connector4066is a marker e.g. includes radiopaque material.

In some embodiments, connector4066is annular (e.g. as illustrated inFIG.40C,FIG.40BandFIG.40Ctogether illustrating, in some embodiments, where connector4066is cylindrical). In some embodiments, bonding material4051is continuous in a contour around connector4066and/or holder4006(e.g. as illustrated inFIG.40C). Alternatively, connector4066and/or bonding material4051form a non-continuous contour e.g. for one or more cross section in the direction ofFIG.40C.

In some embodiments, body4010is porous e.g. includes a mesh. For example,FIG.40Cillustrating body4010porosity where bonding material4051, in some embodiments, enters into pores of body4010.

In some embodiments, device body4008is disconnected from delivery apparatus (e.g. push-wire4022) e.g. after deployment e.g. where disconnecting, in some embodiments, includes one or more feature as illustrated in and/or described regarding detachment zone2392FIG.23.

FIG.41Ais an image of a side view of a device4102, according to some embodiments of the invention.

FIG.41Bis an image of a device4102, according to some embodiments of the invention. In some embodiments, device4102includes one or more feature of device4002FIGS.40A-Cand/or device1202FIGS.12A-F.

Visible inFIGS.41A-Bare a device body4180, a support4140, and a push-wire4122. In some embodiments, holder4106includes electrically insulating material (e.g. PEEK). In some embodiments, for example, as described regarding detachment region2392FIG.23, push-wire4122is detached from device4102using applied electrical stimulation. In some embodiments, a holder proximal portion4136extends proximally outwards from body4108and, optionally, in some embodiments, includes electrically and/or thermally insulating material (e.g. PEEK). In an exemplary embodiment, holder4106is formed by covering and/or coating portion/s of push-wire4122with electrically insulating material (e.g. PEEK).

FIG.42Ais a simplified schematic cross sectional view of a device4202being delivered to a treatment region4253, according to some embodiments of the invention.

FIG.42Bis a simplified schematic cross sectional view of a device4202being deployed in a treatment region4253, according to some embodiments of the invention.

FIG.42Cis a simplified schematic cross sectional view of a deployed device4202in a treatment region4253, according to some embodiments of the invention.

In some embodiments,FIGS.42A-Fillustrate delivery, and deployment of the same device. In some embodiments, device4202includes one or more feature of device1202FIGS.12A-F, and/or device4002FIGS.40A-C, and/or device4102FIGS.41A-B.

In some embodiments, a device body4008and a support4240are formed with a single tubular structure where illustration of body4008using solid lines and support4240using dashed lines, in some embodiments, is to illustrate portions of the tubular structure which, when the device is in an expanded configuration, correspond to the body4008and support4240.

Referring now toFIG.42A, in some embodiments, a delivery catheter4256is positioned with an outlet at the treatment region4253e.g. where the outlet is opposite an opening of an bifurcation aneurysm4253.FIG.42A, in some embodiments, illustrates device4202in a collapsed and/or crimped configuration. Where, in some embodiments, device4202is stretched from the elastically relaxed open configuration into a tubular shaped where an end of the tubular shape is closed at a connection region4211. In some embodiments, the end is connected to a push-wire4222. A potential advantage of the crimped configuration illustrated inFIG.42Ais low profile (e.g. cross sectional area in a direction perpendicular to the cross section illustrated in the figure) of the crimped device, for example, potentially enabling use of a smaller cross section catheter, navigation of tortuous vasculature and/or deployment through small cross section vasculature. In some embodiments, a device collapsed and/or crimped configuration maintains folding of support4040e.g. as illustrated inFIG.12E.

In some embodiments, the device is advanced through catheter4256by pushing pressure applied to push-wire4222.

Referring now toFIG.42B, in some embodiments, as body4208of device4202exits catheter it elastically relaxes body4208forming a curved closure to aneurysm4253.

Referring now toFIG.42C, in some embodiments, as device4202is fully delivered through catheter4256support4240elastically relaxes to fold into position within a volume defined by body4208(e.g. by a base and walls of the body).

In some embodiments, after device4202is deployed, e.g. as illustrated inFIG.42C, push-wire4222is detached from device4202and withdrawn e.g. after and/or along with delivery catheter4256. In some embodiments, holder4206is detached from device4202e.g. and withdrawn along with push-wire4222. In some embodiments, holder4206is a portion of push-wire4222.

FIG.42Dis an image of a deployed device4202in a treatment region4253, according to some embodiments of the invention.

In some embodiments,FIG.42Dillustrates an x-ray image of deployed device4202within a bifurcation aneurysm4253. Visible inFIG.42Dare device body4208, support structure4240, and marker4266. InFIG.42D, delivery apparatus (e.g. including a push-wire and/or a catheter) has been withdrawn.

FIG.42Eis a simplified schematic cross sectional view of a deployed device4202in a treatment region4255, according to some embodiments of the invention.

In some embodiments, treatment region4255is a saccular aneurysm. In some embodiments, delivery and/or deployment to a saccular aneurysm of device4202includes one or more feature as described regarding delivery and/or deployment of device4602FIGS.46A-Ce.g. bending of a delivery catheter.

FIG.42Fis an image of a deployed device4202in a treatment region4255, according to some embodiments of the invention.

In some embodiments,FIG.42Fillustrates an x-ray image of deployed device4202within a saccular aneurysm4255. Visible inFIG.42Fare device body4208, support4240, and marker4266. InFIG.42F, delivery apparatus (e.g. including a push-wire and/or a catheter) has been withdrawn.

FIG.43Ais a simplified schematic cross sectional view of a device4302, according to some embodiments of the invention.

FIG.43Bis a simplified schematic cross sectional view of a portion4311of a device, according to some embodiments of the invention.

In some embodiments,FIG.43Bshows an enlarged view of connection region4311ofFIG.43A.

FIG.43Cis a simplified schematic cross sectional view of a portion4311of a device, according to some embodiments of the invention.

In some embodiments,FIG.43Cillustrates a cross section of portion4311taken along line BB or taken along line CC ofFIG.43B.

Referring now toFIG.43A, in some embodiments, device4302includes a body4308the shape of which includes one or more feature of body4208ofFIGS.42A-F(and/or body1208FIGS.12A-H). In some embodiments, device4302includes a second supporting layer4363(also herein termed a “support”).

In some embodiments, support4363follows a shape of body4308for example, both body4308and support4363having a cup shape, or flattened cup shape and/or walls and a base. Where, in some embodiments, support4363is nested within base4308e.g. occupies a volume described by body4308. In some embodiments, support4363follows a shape of body4308excluding a region4371of support4363adjacent to connection region4311. Where, in some embodiments, within region4371support4373is separated from body4308e.g. by a distance corresponding to a height of connection region4311element/s. For example, where, in some embodiments, region4371length is at least about the same length as height4373, or 0.5-4 times, or 1-3 times, or 1-2 times, or lower or higher or intermediate multiples or ranges of length4373.

In some embodiments, length4371is 1-20%, or 5-20%, or 5-10% of a width4307(in one or more dimension) of device4302.

In some embodiments, portion/s of support4363following a shape of body4308have a separation between 4375 a contour of body4308and a contour of support4363which is at most 0.1-20%, or 0.5-10%, or 1-10% of device width4307and/or height4358of device.

In some embodiments, material of body4308is enters into connection region in a first direction and material of support4373enters into connection region in a second direction. Where the directions, in some embodiments, are generally opposite e.g. at about 180 degrees to each other.

In some embodiments, a separation between support4373and base4308being at least that of connection region rigid element/s at region4371and/or opposing directions of interaction of support4373and body4308with connection region4311contribute to a low profile of device4302when in a collapsed or crimped configuration e.g. as illustrated by device4502FIG.45A.

In some embodiments, body4308is closed at connection region. In some embodiments, support4363is closed at connection region. For example, body4308and/or support4363each being constructed from a tubular material portion which is connected and/or closed at connection region4311.

In some embodiments, closing of body4308and support4363is by separate connectors4366,4367and bonding material portions4351,4355.

Referring now toFIG.43B, in some embodiments, body4308is closed by bonding material4351and/or connector4366and/or holder4306, the various options as described regarding connection of body4008by bonding material4051and/or connector4066and/or holder4006ofFIGS.40A-C.

In some embodiments, support4363is closed by bonding material4353and/or connector4367and/or holder4306, the various options as described regarding connection of body4008by bonding material4051and/or connector4066and/or holder4006ofFIGS.40A-C.

In some embodiments, support4363and body4308are connected by connection of both portions to holder4306. Alternatively or additionally, in some embodiments, support4363and body4308are connected by connecting connectors4366,4367e.g. by welding material4355. Alternatively or additionally, in some embodiments, support4363and body4308are connected by bonding material4353,4351extending to connect the portions (e.g. as illustrated by bonding material5051,FIGS.50A-B). Alternatively or additionally, in some embodiments, function of connectors4366,4377are provided by a single connector (e.g. as illustrated by connector5066FIGS.50A-B).

In some embodiments, connector/s and/or bonding material region/s form closed shapes (e.g. are annular) around a central axis4399of device4302e.g. as illustrated inFIG.43C.

Additional embodiments for attachment of body4308and support4363are illustrated inFIGS.47A-C,FIGS.48A-C, andFIGS.49A-B.

In some embodiments, body4308and support4363are provided connected e.g. are constructed by a single folded tubular structure (e.g. tubular mesh).FIGS.50A-B, in some embodiments, illustrate such an embodiment.

In some embodiments, body4308includes a recessed portion4360at a central region of body as body joins connection region4311. Where, recessed portion4360includes one or more feature of recessed portion/s as described elsewhere in this document.

FIG.44Ais an image of a side view of a device4402, according to some embodiments of the invention.

FIG.44Bis an image of a device4102, according to some embodiments of the invention.

In some embodiments,FIGS.44A-Billustrate device4302ofFIGS.43A-C.

Visible inFIGS.44A-Bare a body4408, a support4463, a central region4457of support4463, a push-wire4422, a connector4466, a holder4406. Visible inFIG.44A-Bat a region of body4408adjacent to connection region4411, are wires protruding from body4408. These wires, in some embodiments, are connected (e.g. laser welded) to body4408. Where, for example, in some embodiments, a protruding wire is connected to a junction (e.g. by welding) where two wires of the mesh cross.

FIG.45Ais a simplified schematic cross sectional view of a device4502being delivered to a treatment region4553, according to some embodiments of the invention.

FIG.45Bis a simplified schematic cross sectional view of a device4502being deployed in a treatment region4553, according to some embodiments of the invention.

FIG.45Cis a simplified schematic cross sectional view of a deployed device4502in a treatment region4553, according to some embodiments of the invention.

FIG.45Dis a simplified schematic cross sectional view of a deployed device4502in a treatment region4553, according to some embodiments of the invention.

FIG.45Eis an image of a deployed device4502in a treatment region4553, according to some embodiments of the invention.

In some embodiments,FIGS.45A-Eillustrate delivery, and deployment of the same device. In some embodiments, device4502includes one or more feature of device4302FIGS.43A-C, and/or device4402FIGS.44A-B.

Referring now toFIG.45A, in some embodiments, a delivery catheter4556is positioned with an outlet of the catheter at the treatment region4553e.g. where the outlet is opposite an opening of an bifurcation aneurysm4553.FIG.45A, in some embodiments, illustrates device4502in a collapsed and/or crimped configuration. Where, in some embodiments, device4502is collapsed by folding both body4508and support4363in a same direction towards a central axis of device4502(central axis4399e.g. as illustrated inFIG.43A). In some embodiments, a shape of support4563at a central region of device4502enables a smaller device cross sectional profile. For example, in some embodiments, narrowing of catheter4556with respect to device4502pushes body4508into contact with elements of connection region4511, narrowing limited by size of connection region4511and thickness of body4508material. But, in some embodiments, where support4563curves away from connection region4511, the profile of device4508is not additionally limited by thickness of support4563material.

In some embodiments, the device is advanced through catheter4556by pushing pressure applied to push-wire4522.

Referring now toFIG.45B, in some embodiments, as body4508(and optionally support4556) of device4502exits catheter4556body4508(and optionally support4556) elastically relaxes forming a curved closure (optionally, with support4556, a double layer closure) to aneurysm4553.

Where,FIG.45C, in some embodiments, illustrates the device elastically relaxed into aneurysm4553. In some embodiments, after device4502is deployed, push-wire4522is detached from device4502and withdrawn e.g. after and/or along with delivery catheter4556. For example, leaving device4502in situ e.g. as illustrated inFIG.45D. In some embodiments, holder4506is detached from device4502e.g. and withdrawn along with push-wire4522. In some embodiments, holder4506is a portion of push-wire4522.

FIG.45Eis an image of a deployed device4502in a treatment region4553, according to some embodiments of the invention.

In some embodiments,FIG.45Eillustrates an x-ray image of deployed device4502within a bifurcation aneurysm4553. Visible inFIG.45Eare device body4508, and marker4566. InFIG.42E, delivery apparatus (e.g. including a push-wire and/or a catheter) has been withdrawn.

FIG.46Ais a simplified schematic cross sectional view of a device4602being delivered to a treatment region4655, according to some embodiments of the invention.

FIG.46Bis a simplified schematic cross sectional view of a device4602being deployed in a treatment region4655, according to some embodiments of the invention.

FIG.46Cis a simplified schematic cross sectional view of a deployed device4602in a treatment region4655, according to some embodiments of the invention.

FIG.46Dis an image of a deployed device4602in a treatment region4655, according to some embodiments of the invention.

In some embodiments, device4602includes one or more feature of device4302FIGS.43A-Cand/or of device4403FIGS.44A-Band/or of device4502FIGS.45A-E.

In some embodiments, device4602is delivered to a saccular aneurysm4655(and/or one or more other device described within this document) by bending of a delivery catheter4656(e.g. a distal end of the delivery catheter) so that an outlet of delivery catheter4656is directed towards an opening of aneurysm4655. Where, in some embodiments, a distal portion of catheter is4656controllably bendable. For example, in some embodiments, a Bandit™ microcatheter is used. For example, in some embodiments, selective tension applied to an elongated element coupled to a distal end of the catheter is used to bend catheter4656.

FIG.52is an image of a portion of a device5208, according to some embodiments of the invention.

In some embodiments, the illustrated portion is an end region of a device (e.g. as defined hereinbelow).

In some embodiments, wire/s of mesh structure/s are connected e.g. at a distal end of structure/s of device bodies e.g. potentially preventing delamination of the mesh. For example, in some embodiments, distal ends of one or more tubular structures of one or more device as described in this document have connections between wires of the mesh. For example, open distal end4391of body4308and/or open distal end of support4393of the device ofFIG.43A. For example, open distal end4091of body4008of the device ofFIGS.40A-C).

In some embodiments, distal wire/s of device mesh are connected (e.g. by welding e.g. laser welding e.g. spot welding) of portion/s of the mesh together. Potentially, connection prevents delamination of the mesh.

In some embodiments, distal end/s5299of wires are connected. For example, where distal ends of two wires, at a distal intersection of the wires, is connected.

In some embodiments, each, or most e.g. more than 90%, of distal ends of wires of a device mesh are connected. In some embodiments, a portion of distal ends are connected, e.g. 20-90%, or lower or higher or intermediate percentages or ranges.

In some embodiments, a proportion of intersection/s proximal of the distal end are connected.

In some embodiments, interconnection of wires of the mesh is for a distal region of the device mesh. For example, interconnection being within a distal 0.1-3 mm, or 0.1-1 mm, or lower or higher or intermediate portions or ranges of the mesh e.g. as measured from a distal end of the mesh.

In some embodiments, a circumferential portion of a mesh body is interconnected e.g. a portion for which radial reinforcement is desired.

A potential advantage of increased connections between wires of the mesh is reduced likelihood of delamination and/or increased mechanical strength of the device e.g. at the region of connections. For example, increased expanding force (e.g. radial expanding force) e.g. of the device on walls of the aneurysm e.g. elastic expanding force of the device. For example, resistance (e.g. radial resistance) to crushing.

A potential disadvantage of fewer connections between wires of the mesh is prevention of movement of wires with respect to each other e.g. during expansion and/or contraction of the device.

FIG.54is an image of a portion of a device5408, according to some embodiments of the invention.

In some embodiments, the illustrated portion is an end region of a device (e.g. as defined hereinbelow).

In some embodiments, one or more end (and/or end region) of one or more wire of a device mesh5408is blunt. A potential benefit being reduced likelihood of the wires traumatizing tissue walls e.g. penetration of the wire/s into a wall of an aneurysm in which the device is positioned. For example having a rounded shape and/or a larger cross section in one or more direction than proximal portion/s of the wire.

In an exemplary embodiment e.g. illustrated inFIG.54, end/s of wires5497are welded to change the shape of the tip5497of the wire end e.g. by laser welding and/or by spot welding.

FIGS.55A-Dare simplified schematic device portions5508a-d, according to some embodiments of the invention.

In some embodiments, the illustrated portions are an end regions of a device (e.g. as defined hereinbelow).

Referring now toFIG.55A, in some embodiments, selected tips5597(e.g. less than all of the tips) of mesh5508aare blunted (e.g. by welding).

Referring now toFIG.55B, in some embodiments, tips5597are blunted and wires are connected5599e.g. connection including one or more feature as described regarding connections5299FIG.52.

Referring now toFIG.55C, in some embodiments, one or more end regions of device5508care blunted. For example, by coating e.g. dip coating of end/s of device5508c.

Referring now toFIG.55D, in some embodiments, one or more end regions of device5508dare blunted by covering e.g. by a film and/or thin material layer5593connected to ends of device5508d.

FIG.53is a simplified schematic cross sectional view of a portion5311of a device, according to some embodiments of the invention.

In some embodiments, a device includes one or more feature of the device depicted inFIGS.43A-C, however with connection of a body5308(corresponding to body4308FIGS.43A-C) and a support5363(corresponding to support4363FIGS.43A-C) as illustrated inFIG.53.

In some embodiments, proximal ends of a tubular structure forming body4308and proximal ends of a tubular structure forming support4363are both connected entering a proximal end of a connector5366lumen. Where connection options are, as described regardingFIGS.43A-Ce.g. bonding material only5351, connector only5366, both bonding material and connector.

In some embodiments, connection of body5308and support5363in the same direction enables the body and support to be in close proximity at the connection region, potentially increasing blocking of blood flow through the layers at the connection region.

In some embodiments, a free end of a portion of the device includes ends of mesh filaments where ends are not gathered by a connector. Where, in some embodiments, for a free end, the shape of a contour the ends is not deformed by one or more element. Where, in some embodiments, multiple ends (or not more than 5, or not more than 10, or not more than 20 or not more than 50 wire ends and/or end regions) and/or end region/s are not bent towards each other. In some embodiments, a free end portion of a device is not folded backwards on and/or into itself.

Exemplary Connection Region Embodiments

In some embodiments,FIGS.47A-C,FIGS.48A-C,FIGS.49A-B,FIGS.50A-Billustrates embodiments of connection regions4711,4811,4911,5011respectively suitable for use with30body4308and/or support4363of device4302FIGS.43A-C(e.g. to replace component/s of connection region431FIGS.43A-C).

FIG.47Ais a simplified schematic cross sectional view of a portion4711of a device, according to some embodiments of the invention.

FIG.47Bis a simplified schematic cross sectional view of a portion of a device, according to some embodiments of the invention.

In some embodiments,FIG.47Billustrates a cross section of portion4711taken along line DD ofFIG.47A.

FIG.47Cis a simplified schematic cross sectional view of a portion of a device, according to some embodiments of the invention.

In some embodiments,FIG.47Cillustrates a cross section of portion4711taken along line EE ofFIG.47A.

In some embodiments, body4708is attached to holder4706by bonding material4753. In some embodiments, support4763is attached to holder4706by bonding material4751. In some embodiments, connector4766is attached by bonding material4751. In some embodiments, adhesive regions4751,4753are attached to each other by weld4755.

Referring toFIGS.47B-C, in some embodiments, one or more of connector4766, bonding material4751, and bonding material4753have a closed shape around holder4706(e.g. annular shape).

FIG.48Ais a simplified schematic cross sectional view of a portion4811of a device, according to some embodiments of the invention.

FIG.48Bis a simplified schematic cross sectional view of a portion4811of a device, according to some embodiments of the invention.

In some embodiments,FIG.48Billustrates a cross section of portion4811taken along line FF ofFIG.48A.

FIG.48Cis a simplified schematic cross sectional view of a portion4811of a device, according to some embodiments of the invention.

In some embodiments,FIG.48Cillustrates a cross section of portion4811taken along line GG ofFIG.48A.

Referring now toFIG.48A, in some embodiments, body4808is attached between connectors4866,4867e.g. by welding4855. In some embodiments, body4808then bends outwards from connection region4811element/s and/or away from support4863. In some embodiments, one or more of connectors4866,4867are attached to holder4806by bonding material4851,4553respectively.

Referring toFIGS.48B-C, in some embodiments, one or more of connector4866, connector4867, bonding material4851, and bonding material4853have a closed shape around holder4806(e.g. annular shape). In some embodiments weld4855has a closed shape around holder4806(but, in some embodiments, is not in contact with holder4806) e.g. an annular shape.

FIG.49Ais a simplified schematic cross sectional view of a portion4911of a device, according to some embodiments of the invention.

FIG.49Bis a simplified schematic cross sectional view of a portion4911of a device, according to some embodiments of the invention.

In some embodiments,FIG.49Billustrates a cross section of portion4911taken along line HH and/or line II ofFIG.49A.

Referring toFIG.49B, in some embodiments, one or more of connector4966, bonding material4951, and bonding material4953have a closed shape around holder4906(e.g. annular shape).

FIG.50Ais a simplified schematic cross sectional view of a portion of a device, according to some embodiments of the invention.

FIG.50Bis a simplified schematic cross sectional view of a portion of a device, according to some embodiments of the invention.

In some embodiments,FIG.50Billustrates a cross section of portion5011taken along line JJ ofFIG.50A.

In some embodiments, body5008and support5063are formed by a single tubular material portion which is folded around connection region5011. In some embodiments, a single connector5066and/or bonding material5051region attach body5088and support5063and/or attach body and support to holder5006.

Referring toFIG.50B, in some embodiments, one or more of connector5066, and bonding material5051have a closed shape around holder4906(e.g. annular shape).

General

It is expected that during the life of a patent maturing from this application many relevant devices for treatment of intravascular abnormality and/or aneurysm will be developed and the scope of the term intravascular device is intended to include all such new technologies a priori.

As used herein the term “about” refers to ±20%

The term “consisting of” means “including and limited to”.