WO2020212972A1

WO2020212972A1 - Adaptable device and method for bridging a neck of an aneurysm

Info

Publication number: WO2020212972A1
Application number: PCT/IL2020/050417
Authority: WO
Inventors: Avraham Rapaport; Danny Farin; Gilad Cibulski
Original assignee: Perflow Medical Ltd.
Priority date: 2019-04-14
Filing date: 2020-04-06
Publication date: 2020-10-22

Abstract

The invention relates to a controlled self-expanding member deployment delivery system comprising: a hollow tube comprising a movable inner tube; a self-expanding member; a proximal holder attached externally to said inner tube and configured to internally hold a proximal end of said self-expanding member; said hollow tube is configured to externally hold said proximal end of said self-expanding member; a distal cap interconnected to a movable tubular member; said tubular member extending proximally from said distal cap, inside said inner tube, to an operator controller; and a movable distal holder surrounding said tubular member and co-located with said distal cap; said distal holder configured to hold internally a distal end of said self-expanding member; said distal cap configured to hold externally said distal end of said self- expanding member.

Description

ADAPTABLE DEVICE AND METHOD FOR BRIDGING

A NECK OF AN ANEURYSM

RELATED APPLICATIQN/S

This application claims the benefit of priority under 35 USC § 119(e) of U.S. Provisional Patent Application No. 62/833,714 filed 14 April 2019, the contents of which are incorporated herein by reference in their entirety.

FIELD AND BACKGROUND OF THE INVENTION

A vascular aneurysm can be described as a localized stretching or distension of an artery due to a weakening of the vessel wall. The vascular distension itself is often referred to as an aneurysm sac and is typically related to a defect in the muscular coating of the artery and is probably developmental in origin. The entrance area that leads from the vessel to the aneurysm sack is often referred as an aneurysm neck. Often an aneurysm can be the site of internal bleeding and, catastrophically, the site of a stroke.

The present invention, in some embodiments thereof, relates to an aneurysm treatment device for at least partially obstructing the neck portion of a vascular aneurysm.

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. A controlled self-expanding member deployment delivery device comprising: a. a self-expanding member having a distal end and a proximal end;

b. a proximal holder configured to hold said proximal end from both inside and outside thereof;

c. a distal holder configured to hold said distal end from both inside and outside thereof.

Example 2. The device of example 1, wherein said proximal holder comprises :

a. a hollow tube;

b. an inner tube located inside said hollow tube; and

c. a first annular member comprising a plurality of protrusions externally attached to said inner tube. Example 3. The device of example 1 or 2, wherein said first annular member comprising said plurality of protrusions of said proximal holder is configured to hold from inside said proximal end of said self-expanding member.

Example 4. The device of anyone of examples 1-3, wherein said hollow tube of said proximal holder is configured to hold from outside said proximal end of said self-expanding member.

Example 5. The device of any one of examples 1-4, wherein said distal holder comprises: a. a distal cap;

b. a movable tubular member interconnected to said distal cap; and

c. a second annular member comprising a plurality of protrusions surrounding said tubular member and co-located with said distal cap.

Example 6. The device of any one of examples 1-5, wherein said second annular member comprising protrusions of said distal holder is configured to hold from inside said distal end of said self-expanding member.

Example 7. The device of any one of examples 1-6, wherein said distal cap is configured to hold from outside said distal end of said self-expanding member.

Example 8. The device of any one of examples 1-7, wherein said tubular member extends proximally from said distal cap, inside said inner tube, to an operator controller.

Example 9. The device of any one of examples 1-8, wherein said cap is atraumatic.

Example 10. The device of any one of examples 1-9, wherein said cap comprises a diameter from about 0.4 mm and 0.7 mm.

Example 11. The device of any one of examples 1-10, wherein said plurality of protrusions are configured to be inserted in openings of said self-expanding member.

Example 12. The device of any one of examples 1-11, wherein an outer diameter over said plurality of protrusions is between 0.4 mm and 0.9 mm.

Example 13. The device of any one of examples 1-12, wherein said first and second annular members comprise an annular member outer diameter between 70% and 98% of said outer diameter.

Example 14. The device of any one of examples 1-13, wherein a number of axial rows of said protrusions of said first and said second annular bodies are between 1% and 40% of the length of said self-expanding member in a stretched reduced diameter when loaded in said device. Example 15. The device of any one of examples 1-14, wherein said deployment delivery device is sized to be slidably disposed within a microcatheter having a diameter from about 0.5mm to about 4mm.

Example 16. The device of any one of examples 1-15, wherein said cap comprises a diameter at least 20% smaller than the internal diameter of said microcatheter.

Example 17. The device of any one of examples 1-16, wherein said distal holder comprises an attachment member, which enables controllable distal/proximal movements of said distal holder by a user.

Example 18. The device of any one of examples 1-17, wherein said attachment member optionally runs in an independent tube inside said hollow tube.

Example 19. The device of any one of examples 1-18, wherein said attachment member is a round or flattened wire.

Example 20. The device of any one of examples 1-19, wherein said self-expanding member is a memory shape self-expanding member.

Example 21. The device of any one of examples 1-20, wherein said inner tube is a movable inner tube configured to move distally and proximally.

Example 22. The device of any one of examples 1-21, wherein instead of said plurality of protrusions said first annular member comprises a textured surface externally attached to said inner tube.

Example 23. The device of any one of examples 1-22, wherein instead of said plurality of protrusions said first annular member comprises an elastic member externally attached and squeezed into said inner tube.

Example 24. The device of any one of examples 1-23, wherein instead of said plurality of protrusions said first annular member comprises a friction surface externally attached to said inner tube.

Example 25. The device of any one of examples 1-24, wherein said first annular member and said inner tube are a single component.

Example 26. A method for controlled deployment of a self-expanding member, comprising:

a. constraining a distal end of said self-expanding member from both inside and outside thereof;

b. constraining a proximal end of said self-expanding member from both inside and outside thereof;

c. adjusting at least one axial position of said self-expanding member; d. releasing said distal end;

e. releasing said proximal end.

Example 27. The method of example 26, wherein said adjusting at least one axial position of said self-expanding member further comprises bending outwardly a part of said self-expanding member towards a desired location for said deployment.

Example 28. The method of example 26 or 27, wherein said bending outwardly comprises at least one selected from the group consisting of:

a. axially moving said distal towards said proximal end;

b. axially moving said proximal end towards said distal end;

c. axially moving said distal and said proximal end in relation and towards to each other.

Example 29. The method of any one of examples 26-28, wherein said bending outwardly comprises not deforming said self-expanding member.

Example 30. The method of any one of examples 26-29, wherein when said part of said self-expanding member is not located at said desired location, then straightening inwardly said self-expanding member to its original configuration.

Example 31. The method of any one of examples 26-30, wherein straightening inwardly said self-expanding member comprises at least one selected from the group consisting of:

a. axially moving said distal away from said proximal end;

b. axially moving said proximal end away from said distal end;

c. axially moving said distal and said proximal end in relation and away from each other.

Example 32. The method of any one of examples 26-31, wherein said constraining a distal end comprises constraining said distal end between a cap and a distal holder.

Example 33. The method of any one of examples 26-32, wherein said constraining a proximal end comprises constraining said proximal end between a hollow tube and a proximal holder; said proximal holder located on an internal tube, said internal tube contained inside said hollow tube.

Example 34. The method of any one of examples 26-33, wherein said releasing said distal end comprises moving distally said cap.

Example 35. The method of any one of examples 26-34, wherein said releasing said distal end comprises moving proximally said distal holder.

Example 36. The method of any one of examples 26-35, wherein said releasing said proximal end comprises moving proximally said hollow tube.

Example 37. The method of any one of examples 26-36, wherein said releasing said proximal end comprises moving distally said proximal holder. Example 38. A method of positioning a controlled self-expanding member in proximity to an aneurysm neck, comprising:

a. bringing a device comprising said controlled self-expanding member in close proximity with said aneurysm neck, said controlled self-expanding member comprising a distal end and a proximal end, said device comprising a proximal holder configured to hold said proximal end from both inside and outside thereof and a distal holder configured to hold said distal end from both inside and outside thereof ;

b. positioning said controlled self-expanding member at a desired location;

c. bending outwardly a central part of said self-expanding member;

d. assessing location of said central part of said self-expanding member;

e. when location is correct, then releasing a distal end of said self-expanding member and then releasing a proximal end of said self-expanding member;

f. when location is incorrect, then straightening inwardly said central part of said self expanding member and perform“c.”

Example 39. The method of example 38, wherein said bending outwardly a central part of said self-expanding member comprises not deforming said self-expanding member.

Example 40. The method of example 38 or 39, wherein said bending outwardly comprises at least one selected from the group consisting of:

a. axially moving said distal towards said proximal end;

b. axially moving said proximal end towards said distal end;

Example 41. The method of any one of examples 38-40, wherein said straightening inwardly said central part of said self-expanding member comprises at least one selected from the group consisting of:

a. axially moving said distal away from said proximal end;

b. axially moving said proximal end away from said distal end;

According to an aspect of some embodiments of the present invention there is provided a controlled self-expanding member deployment delivery device comprising: a self-expanding member; a proximal holder configured to hold from inside and outside a proximal end of said self-expanding member; a distal holder configured to hold from inside and outside a distal end of said self-expanding member. According to some embodiments of the invention, said proximal holder comprises: a hollow tube; a movable inner tube located inside said hollow tube; and a first annular member comprising protrusions externally attached to said inner tube.

According to some embodiments of the invention, said first annular member comprising said plurality of protrusions of said proximal holder is configured to hold from inside said proximal end of said self-expanding member.

According to some embodiments of the invention, said hollow tube of said proximal holder is configured to hold from outside said proximal end of said self-expanding member.

According to some embodiments of the invention, said distal holder comprises: a distal cap; a movable tubular member interconnected to said distal cap; and a second annular member comprising protrusions surrounding said tubular member and co-located with said distal cap.

According to some embodiments of the invention, said second annular member comprising protrusions of said distal holder is configured to hold from inside said distal end of said self-expanding member.

According to some embodiments of the invention, said distal cap is configured to hold from outside said distal end of said self-expanding member.

According to some embodiments of the invention, said tubular member extends proximally from said distal cap, inside said inner tube, to an operator controller.

According to some embodiments of the invention, said cap is atraumatic.

According to some embodiments of the invention, said cap comprises a diameter from about 0.4 mm and 0.7 mm.

According to some embodiments of the invention, said plurality of protrusions are configured to be inserted in openings of said self-expanding member.

According to some embodiments of the invention, an outer diameter over said plurality of protrusions is between 0.4 mm and 0.9 mm.

According to some embodiments of the invention, said first and second annular members comprise an annular member outer diameter between 70% and 98% of said outer diameter.

According to some embodiments of the invention, a number of axial rows of said protrusions of said first and said second annular bodies are between 1% and 40% of the length of said self-expanding member in a stretched reduced diameter when loaded in said device.

According to some embodiments of the invention, said deployment delivery device is sized to be slidably disposed within a microcatheter having a diameter from about 0.5mm to about 4mm. According to some embodiments of the invention, said cap comprises a diameter at least 20% smaller than the internal diameter of said microcatheter.

According to some embodiments of the invention, said distal holder comprises an attachment member, which enables controllable distal/proximal movements of said distal holder by a user.

According to some embodiments of the invention, said attachment member runs in an independent tube inside said hollow tube.

According to some embodiments of the invention, said attachment member is a round or flattened wire.

According to some embodiments of the invention, said self-expanding member is a memory shape self-expanding member.

According to some embodiments of the invention, said inner tube is a movable inner tube configured to move distally and proximally.

According to some embodiments of the invention, instead of said plurality of protrusions said first annular member comprises a textured surface externally attached to said inner tube.

According to some embodiments of the invention, instead of said plurality of protrusions said first annular member comprises an elastic member externally attached and squeezed into said inner tube.

According to some embodiments of the invention, instead of said plurality of protrusions said first annular member comprises a friction surface externally attached to said inner tube.

According to some embodiments of the invention, said first annular member and said inner tube are a single component.

According to an aspect of some embodiments of the present invention there is provided a method for controlled deployment of a self-expanding member, comprising: constraining a distal end of said self-expanding member; constraining a proximal end of said self-expanding member; adjusting at least one axial position of said self-expanding member; releasing said distal end; and releasing said proximal end.

According to some embodiments of the invention, said adjusting at least one axial position of said self-expanding member further comprises bending outwardly a part of said self expanding member towards a desired location for said deployment.

According to some embodiments of the invention, said bending outwardly comprises at least one selected from the group consisting of: a. axially moving said distal towards said proximal end; b. axially moving said proximal end towards said distal end; c. axially moving said distal and said proximal end in relation and towards to each other. According to some embodiments of the invention, said bending outwardly comprises not deforming said self-expanding member.

According to some embodiments of the invention, when said part of said self-expanding member is not located at said desired location, then straightening inwardly said self-expanding member to its original configuration.

According to some embodiments of the invention, straightening inwardly said self expanding member comprises at least one selected from the group consisting of: a. axially moving said distal away from said proximal end; b. axially moving said proximal end away from said distal end; c. axially moving said distal and said proximal end in relation and away from each other.

According to some embodiments of the invention, said constraining a distal end comprises constraining said distal end between a cap and a distal holder.

According to some embodiments of the invention, said constraining a proximal end comprises constraining said proximal end between a hollow tube and a proximal holder; said proximal holder located on an internal tube, said internal tube contained inside said hollow tube.

According to some embodiments of the invention, said releasing said distal end comprises moving distally said cap.

According to some embodiments of the invention, said releasing said distal end comprises moving proximally said distal holder.

According to some embodiments of the invention, said releasing said proximal end comprises moving proximally said hollow tube.

According to some embodiments of the invention, said releasing said proximal end comprises moving distally said proximal holder.

According to an aspect of some embodiments of the present invention there is provided a method of positioning a controlled self-expanding member in proximity to an aneurysm neck, comprising: bringing a device comprising said controlled self-expanding member in close proximity with said aneurysm neck; positioning said controlled self-expanding member at a desired location; bending outwardly a central part of said self-expanding member; assessing location of said central part of said self-expanding member; when location is correct, then releasing a distal end of said self-expanding member and then releasing a proximal end of said self-expanding member; when location is incorrect, then straightening inwardly said central part of said self-expanding member and perform“c”.

According to some embodiments of the invention, said bending outwardly a central part of said self-expanding member comprises not deforming said self-expanding member. According to some embodiments of the invention, said bending outwardly comprises at least one selected from the group consisting of: a. axially moving said distal towards said proximal end; b. axially moving said proximal end towards said distal end; c. axially moving said distal and said proximal end in relation and towards to each other.

According to some embodiments of the invention, said straightening inwardly said central part of said self-expanding member comprises at least one selected from the group consisting of: a. axially moving said distal away from said proximal end; b. axially moving said proximal end away from said distal end; c. axially moving said distal and said proximal end in relation and away from each other.

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

Implementation of the method and/or system of embodiments of the invention can involve performing or completing selected tasks manually, automatically, or a combination thereof. Moreover, according to actual instrumentation and equipment of embodiments of the method and/or system of the invention, several selected tasks could be implemented by hardware, by software or by firmware or by a combination thereof using an operating system.

For example, hardware for performing selected tasks according to embodiments of the invention could be implemented as a chip or a circuit. As software, selected tasks according to embodiments of the invention could be implemented as a plurality of software instructions being executed by a computer using any suitable operating system. In an exemplary embodiment of the invention, one or more tasks according to exemplary embodiments of method and/or system as described herein are performed by a data processor, such as a computing platform for executing a plurality of instructions. Optionally, the data processor includes a volatile memory for storing instructions and/or data and/or a non-volatile storage, for example, a magnetic hard-disk and/or removable media, for storing instructions and/or data. Optionally, a network connection is provided as well. A display and/or a user input device such as a keyboard or mouse are optionally provided as well. Some embodiments of the present invention may be described below with reference to flowchart illustrations and/or block diagrams of methods, apparatus (systems) and computer program products according to embodiments of the invention. It will be understood that each block of the flowchart illustrations and/or block diagrams, and combinations of blocks in the flowchart illustrations and/or block diagrams, can be implemented by computer program instructions. These computer program instructions may be provided to a processor of a general purpose computer, special purpose computer, or other programmable data processing apparatus to produce a machine, such that the instructions, which execute via the processor of the computer or other programmable data processing apparatus, create means for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

These computer program instructions may also be stored in a computer readable medium that can direct a computer, other programmable data processing apparatus, or other devices to function in a particular manner, such that the instructions stored in the computer readable medium produce an article of manufacture including instructions which implement the function/act specified in the flowchart and/or block diagram block or blocks.

The computer program instructions may also be loaded onto a computer, other programmable data processing apparatus, or other devices to cause a series of operational steps to be performed on the computer, other programmable apparatus or other devices to produce a computer implemented process such that the instructions which execute on the computer or other programmable apparatus provide processes for implementing the functions/acts specified in the flowchart and/or block diagram block or blocks.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S)

Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.

In the drawings:

Figure 1 is a schematic representation of an exemplary delivery system, according to some embodiments of the present invention;

Figures 2a-2b are schematic representation of exemplary distal and proximal holders, according to some embodiments, of the present invention;

Figures 3a-3f are flowcharts of an exemplary method, according to some embodiments of the present invention; and Figures 4a-4i are schematic representations of an exemplary method, according to some embodiments of the present invention.

DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

OVERVIEW

An aspect of some embodiments thereof, relates to devices and methods for treating an aneurysm and, more particularly, but not exclusively, to an aneurysm neck occlusion device configured to provide a controllable release of a self-expanding member.

In some embodiments, the controllable release of the self-expanding member includes choosing the location of the release of the self-expanding member. In some embodiments, the controllable release of the self-expanding member avoids unwanted movement of the self expanding member while being released.

In some embodiments, the self-expanding member is configured to fittingly engage walls of a blood vessel at a location of an aneurysm, such as a saccular or a fusiform aneurysm, to obstruct sufficient flow to and/or from the aneurysm to allow a thrombus to form and/or to prevent from one or more coils which have optionally been introduced into the aneurysm from protruding out of the aneurysm and into the vessel.

In some embodiments, the self-expanding member comprises a tubular or balloon- like (e.g. elliptical) structure, formed of a plurality of wires. Optionally, the wires are weaved into a braided mesh.

In some embodiments, the device is configured for selectively modifying one or more diameters of the self-expanding member. In some embodiments, the device comprises a push/pull cable, optionally a wire, optionally a tube, which is operatively coupled to the self expanding member, and is movable relative to an outer tube from which the self-expanding member extends. In some embodiments, the cable extends in a proximal direction to be manipulated by a user from outside the body.

In some embodiments, a diameter of the self-expanding member is adjusted a plurality of times, for example to obtain a close fit of at least a portion of the walls of the self-expanding member to walls of the blood vessel exhibiting the aneurysm. Additionally or alternatively, the self-expanding member is expanded and/or contracted to modify a positioning of the member in the vessel.

In some embodiments, the self-expanding member is introduced into the vessel and adjusted to a desired configuration, using one or more tubes or wires and then the shape is modified using, for example, a push/pull wire. An aspect of some embodiments of the invention relates to a delivery device for a self expanding member, which is configured to hold externally and internally a distal end and a proximal end of said self-expanding member. A potential advantage of this configuration is that holding externally and internally a distal end and a proximal end of said self-expanding member avoids causing non-wanted deformations on said self-expanding member while in the process of correct positioning of said self-expanding member. In some embodiments, the distal end and the proximal end of said self-expanding member can be released independently from each other. In some embodiments, proximal movements of the distal end of said delivery device, while holding said distal and proximal end of said self-expanding member, cause a part of said self-expanding member to bulge outwards, thereby allowing the user to assess the location where said self expanding member is going to be released. In some embodiments, bulging outwards does not cause non-wanted deformations the self-expanding member.

An aspect of some embodiments, relates to devices and methods for treating an aneurysm and, more particularly, but not exclusively, to an aneurysm neck occlusion device configured to provide a controllable positioning and repositioning of a self-expanding member.

In some embodiments, positioning and repositioning of the self-expanding member does not cause physical distortions on the self-expanding member.

It is noted that the self-expanding member may comprise various shapes, such as a balloon-like (elliptic) shape, in which a proximal and/or distal ends of the wire mesh are crimped or are otherwise clumped together; a cylindrical shape; an hourglass shape and/or any other profiles. In some embodiments, the self-expanding member is symmetrical with respect to the longitudinal axis and/or with respect to the transverse axis of the member. Alternatively, the member is asymmetrical, for example having a first wall portion which is located (at an initial relaxed configuration and/or at an expanded or contracted configuration) at a radius larger than a second wall portion of the member, for example to engage the aneurysm neck on the side of the vessel wall in which the first member wall portion is positioned and least interrupt flow on the opposite side of the vessel (which does not exhibit the aneurysm) in which the second member wall portion is located.

It is noted that while some embodiments of the invention are described with respect to a cerebral blood vessel exhibiting an aneurysm, the devices and/or methods described herein may be suitable for treating vasculature other than the cerebral vessels, such as aortic vasculature and/or abdominal vasculature and/or peripheral vasculature.

The term "proximal", as referred to herein, may include a direction corresponding with the user end (e.g. physician interface), for example being a direction in which the device is introduced to the vessel. The term "distal" as referred to herein may include a direction corresponding with a more distant vessel location, farthest away from user end of the device.

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

EXEMPLARY SYSTEM AND DEVICE

Fig. 1 shows an exemplary delivery system 100 for deploying a self-expanding member in a blood vessel exhibiting an aneurysm and occluding the neck of said aneurism, according to some embodiments of the invention.

In some embodiments, a patient is diagnosed with a cerebral aneurysm, for example using angiography, imaging, and/or CSF analysis methods. In some embodiments, a device comprising a self-expanding member is introduced to the blood vessel (e.g. the middle cerebral artery) exhibiting the aneurysm, for example by a physician.

Optionally, the delivery system is introduced through the femoral artery, and advanced through the vascular system, into the cerebral circulation, and into the blood vessel exhibiting the aneurysm. Alternatively, the delivery system is introduced in an endonasal approach, and/or any other methods suitable for delivering the self-expanding member into the vessel, to a location of the aneurysm.

In some embodiments, the delivery system 100 includes a catheter 102 (not shown). In some embodiments, the system 100 further includes an elongate device 104, which is configured to slide within the catheter 102. In some embodiments, the elongate device includes a hollow tube 106 and a distal cap 108. In some embodiments, the system comprises an internal mechanism 110. In some embodiments, the internal mechanism 110 comprises a central wire or tubular member 112 attached, on its distal end, to the cap 108, and on its proximal end to the operator controller (not shown). In some embodiments, the central wire or tubular member 112 is used to control the movement of the cap 108 distally and proximally. In some embodiments, the internal mechanism 110 further comprises a self-expanding member 114, reversibly attached at its distal end to a distal holder 116, and at its proximal end to a proximal holder 118. In some embodiments, the self-expanding member 114 is further held by the cap 108 on its distal end and by the hollow tube 106 on its proximal end. In some embodiments, the distal holder 116 comprises an attachment member 120 which enables the movement distally and proximally of the distal holder 116 along the central wire or tubular member 112. In some embodiments, the attachment member 120 is a round or flattened wire. In some embodiments, attachment member 120 runs inside the hollow tube 106 or in an independent tube 122 inside the hollow tube 106. In some embodiments, the proximal holder 118 is attached at the distal end of an inner tube 124 which runs inside the hollow tube 106 and is separated from tube 122. In some embodiments, the inner tube 124 is configured to move distally and proximally inside the hollow tube 106. In some embodiments, the central wire or tubular member 112 runs inside the inner tube 124.

In some embodiments, the internal mechanism 110 moves distally and proximally inside hollow tube 106. In some embodiments, the internal mechanism 110 moves proximally so the proximal end of the cap 108 is in contact with the distal end of the hollow tube 106 to completely enclose the internal mechanism 110 and provide a close configuration of the device. In some embodiments, the internal mechanism 110 moves distally so the proximal end of the cap 108 is not in contact with the distal end of the hollow tube 106 to expose the internal mechanism 110 and provide an open configuration of the device. In some embodiments, the internal mechanism 110 does not move inside hollow tube 106. In some embodiments, the elongated device is brought in an open configuration to the location of the aneurysm.

In some embodiments, when both the distal and proximal ends of the self-expanding member 114 are coupled at the distal end to distal holder 116, within cap 108 and at the proximal end to proximal holder 118, within the distal end of hollow tube 106, the movement of the distal cap 108 relative to hollow tube 106 is obtained by axially pulling and/or pushing central wire or tubular member 112. Optionally, pulling central wire or tubular member 112 approximates cap 108 towards hollow tube 106, thereby shortening a length of the self-expanding member 114 and expanding its diameter; respectively, advancing central wire or tubular member 112 stretches the self-expanding member 114 distally, reducing a diameter of self-expanding member 114.

Therefore, in some embodiments, the self-expanding member, which comprises a distal end and a proximal end, is held, on its proximal end by the proximal holder, the proximal holder configured to hold the proximal end from both inside and outside thereof, while also held on its distal end by the distal holder, the distal holder configured to hold the distal end from both inside and outside thereof.

In some embodiments, at any time, the distal end and/or the proximal end are held only from either the inside or the outside. For example, while the proximal end is being held from the inside and outside, the distal end can be held from either the inside or the outside alone, and vice versa, an any combination of holding thereof. Exemplary microcatheter 102

In some embodiments, the system includes microcatheter having a proximal end and a distal end with a lumen therebetween. In some embodiments, the lumen comprises a lumen diameter and the distal end is configured for advancement into the vessel beyond the proximal position. In some embodiments, the catheter 102 may be a microcatheter (i.e. diameter of 5- French or less) for use in small vessels (2 mm to 4 mm), typically intracranial blood vessels. In some embodiments, the catheter 102 can be constructed from hollow tubing, such as a flexible polymer (e.g., polyether-block- amide, commercially available under the name PEBAX from the ARKEMA GROUP of Paris, France) tubular extrusion. In some embodiments, the catheter 102 can be reinforced with braiding and configured for withstanding high pressure for delivering liquid medication. The catheter 102 is generally configured for use over a guidewire, but may additionally include provisions for steering. The catheter 102 can also include radio-opaque elements to aid fluoroscopic visualization. In some embodiments, the microcatheter comprises a diameter from about 0.5 mm to about 4mm. Optionally from about 0.7 mm to about 3 mm. Optionally from about 1mm to about 2mm. For example, the diameter can be 0.5 mm, 0.7 mm, 1 mm, 1.5mm or 2 mm.

In some embodiments, at the most distal end of the delivery device there is a cap 108. In some embodiments, a central wire or tubular member 112 is attached, on its distal end, to the cap 108. In some embodiments, cap 108 is long enough and/or wide enough to receive the distal end of central wire or tubular member 112 within it. In some embodiments, cap 108 is long enough and/or wide enough to enclose a distal holder 116 within it. In some embodiments, cap 108 is long enough and/or wide enough to enclose a distal end of self-expanding member 114 within it.

In some embodiments, a diameter of cap 108 is at least 20%, 50%, 70% or intermediate, larger or smaller percentages smaller than the vessel diameter, such as to prevent occluding the vessel and provide at least partial patency. Exemplary dimensions of cap 108 include a diameter between 0.4 mm and 0.7 mm, between 0.2 mm and 0.5 mm, between 0.4 mm and 1 mm, or intermediate, larger or smaller ranges. In some embodiments, the cap is designed to be atraumatic, for example, a distal end of the cap may comprise of a soft material such as rubber or silicon so as to reduce damage to the tissue (e.g. the vessel walls). Optionally, the cap comprises a high friction material and/or coating, for example at the inner walls of the cup, which may assist holding the distal portion of the self-expanding member 114 in place. In some embodiments, the cap 108 can be constructed from radiopaque polymer incorporates a radiopaque filler or pigment. For example, typical filler materials include barium sulfate (BaS04), bismuth subcarbonate, or certain metals such as tungsten (W). Optionally, other radiopaque fillers are pigments for incorporation into a polymer tube including bismuth oxychloride and other bismuth salts such as bismuth subnitrate and bismuthoxide, as disclosed for example in U.S. Pat. No. 3,618,614.

In some embodiments, the self-expanding member can be constructed from a resilient material, such as nickel-titanium alloy or stainless steel, or a mixture of different metals (e.g. 15 Ni-Ti wires and 1 Platinum or Platinium Tungsten), since Platinum wire is relatively easier to see under fluoroscopy. The self-expanding member can be coated to affect lubricity or to improve the biocompatibility of the device.

In some embodiments, the self-expanding member is a bare-metal self-expanding member, a drug-eluting self-expanding member, a bioabsorbable self-expanding member, a dual therapy self-expanding member (combination of both drug and bioengineered self-expanding member), or a covered self-expanding member.

In some embodiments, the self-expanding member is a memory shape self-expanding member, optionally comprising a metallic structure to provide strength.

In some embodiments, the device 100 is pre-assembled by loading the self-expanding member 114 onto the delivery system, outside the body. Optionally, loading is performed by the user, such as a physician. In some embodiments, the physician selects a self-expanding member from a kit comprising self-expanding members of various sizes and/or shapes and/or mechanical properties, for example according to the anatomy of the treatment site, the patient condition, and/or other parameters. Additionally or alternatively, loading of the self-expanding member is performed during manufacturing, and the physician operates the ready-to-use device. Optionally, operating comprises controlling the wire, for example during deployment, and/or detaching the self-expanding member from the delivery system, such as to permanently or temporarily deploy it in the vessel.

In some embodiments, the self-expanding member comprises one or more openings through which blood can flow. In some embodiments, the self-expanding member is structured to allow non-radial flow, such as axial flow, through the vessel. In an example, the member comprises a braided structure formed of a plurality of meshed wires which define the openings therebetween. By allowing non-radial flow of blood, in some embodiments, at least a partial patency of the vessel is maintained and/or obtained and/or restored.

In some embodiments, a structure of self-expanding member 114 is suitable for plastic and/or elastic deformation, to provide the shaping properties needed for fitting in the vessel, and, in some embodiments, to slightly protrude into the aneurysm neck, such as to obtain a closer alignment with the neck, and/or“packing” the coils inside the aneurysm and/or restrict the flow. In some embodiments, this is called a wanted deformation, which is different from non-wanted deformations. In some embodiments, non-wanted deformation means deformations caused to the self-expandable member which can potentially cause damage to the vessel and/or reduce the efficacy of the self-expanding member. For example, if the distal end of the self-expanding member is deformed so the distal end protrudes towards the center of the vessel, away from the vessel wall, this may cause over time an obstruction of the vessel as organic material would aggregate on the protruding member over time. Another example, if the self-expanding member is deformed in a way that it does not efficiently occlude the neck of the aneurysm, over time, the coils can escape the aneurysm sac, thereby reversing the treatment. In some embodiments, non- wanted deformation means deformations that causes the self-expandable member to lose the ability to recover its original and/or intended shape upon deployment. In some embodiments, contrary to non-wanted deformations, there are wanted deformations, which are natural planned deformations that happen on and by the self-expanding member due to the way it is designed, for example due to the use of combination of different materials for the wires, combination of different treatments on the wires, or combinations thereof, which will enable the self-expanding member to slightly protrude into the aneurysm neck, such as to obtain a closer alignment with the neck, and/or“packing” the coils inside the aneurysm and/or restrict the flow inside the aneurysm sac. In some embodiments, deformations can be divided in two categories: elastic deformations, which are reversible, and plastic deformations, which are irreversible. In some embodiments, wanted deformations are defined as elastic deformations due to the fact it is a self-expanding member. In some embodiments, the self-expanding member is under load (squeezed) while it is assembled onto the delivery catheter and introduced into the vessel. In some embodiments, in this state, the proximal end and the distal end of the self-expandable member are in the largest distance and the cross sections along it, are minimal. In some embodiments, during positioning, the load on the self-expandable member is released. In some embodiments, then the cross sections along the device get bigger. In some embodiments, the free- state (where there is no load) of the self-expandable member may be exhibited only "outside the body" (there, it achieves its nominal diameter under zero load), since when it is inside the vessel it is desired that the self- expanding member continues to apply forces towards the wall vessel due to the expansion. In some embodiments, this continued applying of forces towards the vessel walls is what allow the slightly protrusion into the aneurysm neck. In some embodiments, while in the vessel, the self expanding member is always under some elastic deflection which provides the radial forces that allow to hold the device at place. In some embodiments, when part of the self-expanding member protrudes into the aneurysm, this only section may release all its elastic deformation. In some embodiments, wanted deformations (elastic deformations) of the self-expandable member due to the movement applied to the ends of it, are measured as the ratio between the change in the length/diameter of the member (as a result of a movement), to the initial length/diameter of it. In some embodiments, the measurement of the deformation is dimensionless as it is the change of a size divided by the initial size. In some embodiments, the measurements of the non-wanted deformations (plastic deformations) are those measured forces that cause deformations that do not allow the self-expanding member to achieve its intendent nominal diameter under zero load.

In some embodiments, self-expanding member 114 comprises a combination of shapeable elements, such as annealed or semi-annealed wires, and elastic or super-elastic elements. Optionally, the wires are formed of a similar material, such as nitinol, processed using different methods, such as thermal treatment. Alternatively, the wires are formed of different materials.

In some embodiments, the openings defined between the wires at a wall portion may be different in size (e.g. larger than) as compared to openings at one or more other portions of self expanding member 114, due to, for example, spreading of a wall portion of the self-expanding member over a larger area at the aneurysm neck.

In some embodiments, the number of wires at a wall portion may be different as compared to openings at one or more other portions of self-expanding member 114.

In some embodiments, the self-expanding member is delivered into the vessel in a collapsed, reduced diameter configuration. Optionally, the member self-expands to an initial diameter when released from the delivery system. In some embodiments, the initial diameter may be, for example, 5% of the vessel diameter at the aneurysm location, 10% of the vessel diameter at the aneurysm location, 15% of the vessel diameter at the aneurysm location, and/or intermediate, larger or smaller percentages of the vessel diameter. In some embodiments, the member self-expands into a diameter which is 5%, 20%, 45%, 70%., 85% or intermediate, larger or smaller percentages of a collapsed diameter of the self-expanding member. Optionally, the initial diameter to which the member self-expands is preselected to match a vessel of a certain diameter. Alternatively, the member remains in a collapsed configuration until modified by the user. In some embodiments, the member is expanded to a diameter in which the walls of the member contact the vessel walls, but do not exert substantial pressure such as radial pressure onto the vessel walls. Optionally, an amount of radial pressure exerted by the walls of the self expanding member onto the blood vessel walls is sufficient for obtaining hold of the self expanding member by the vessel walls, preventing the member from being carried away from the aneurysm location by flow.

In some embodiments, the self-expanding member is axially positioned in the vessel such that a central portion of the member extends across the aneurysm neck. Alternatively, a distal or proximal portion of the self-expanding member extends across the aneurysm neck.

In some embodiments, the self-expanding member blocks coils that were delivered into the aneurysm from exiting the aneurysm. This may be potentially useful in cases in which a dome diameter to neck diameter ratio of the aneurysm is relatively small, for example less than 2, less than 1.5, less than 1.8, or intermediate, larger or smaller ratios, in which the neck substantially does not produce a“bottle neck” effect, and the risk of coils passing through the relatively wide neck portion and out into the vessel is increased. Optionally, openings of the self-expanding member are small enough so as to prevent entangling of the coils (or ends of the coils which may extend externally to the aneurysm) with the wires of the self-expanding member.

In some embodiments, a wall portion of the self-expanding member slightly protrudes into the aneurysm neck, optionally producing an axial segment of larger diameter along the self expanding member.

In some embodiments, the self-expanding member is detached from the delivery system. Optionally, the member is detached from the delivery system after an indication of initial flow stasis and/or thrombosis in the aneurysm is obtained, indicating that the selected position of the member is suitable for blocking coils from exiting the aneurysm and/or for restricting radial blood flow to and/or from the aneurysm. Optionally, the delivery system is retracted from the body, while the member remains deployed in the vessel.

It is noted that intermediate, larger and smaller expansion configurations of the self expanding member are possible, and that in some embodiments the self-expanding member is configured for expanding to a plurality of diameters, such as 2 mm, 3 mm, 5 mm, 9 mm, 10 mm, 15 mm, 20 mm, 25 mm, 30 mm or intermediate, larger or smaller number of diameters.

In some embodiments, the self-expanding member comprises a braided mesh structure comprising a plurality of wires, for example between 16-100 wires, such as 16 wires, 24 wires, 48 wires, 80 wires or intermediate, larger or smaller number of wires. In some embodiments, a thickness of each wire, optionally being a diameter of a wire in cases in which the wire is circular in cross section, ranges between 25-125 micrometer, for example 30 micrometer, 50 micrometer, 85 micrometer or intermediate, larger or smaller thicknesses. In some embodiments, the wire comprises a rectangular cross section profile, an oval cross section profile, a flattened cross section profile and/or other cross sectional profiles.

Additionally or alternatively, the self-expanding member comprises a different structure, for example a helical spring structure, a structure comprising a plurality of cage-like compartments, for example arranged as a bead chain, and/or other structures.

Exemplary distal holder 116 and proximal holder 118

Referring now to Figures 2a and 2b, showing exemplary distal and proximal holders, according to some embodiments of the invention. In some embodiments, the distal holder and the proximal holder are made of an annular body 200. In some embodiments, the distal holder and the proximal holder comprise a series of protrusions 202 on the external surface of the annular body 200. In some embodiments, the protrusions hold in place the self-expanding member 114. In some embodiments, protrusions 202 are inserted in openings on the self-expanding member 114 to hold the self-expanding member 114 in place. Optionally, instead of protrusions, the annular body comprises a textured surface and/or an elastic member squeezed on the surface and/or a friction surface. In some embodiments, the role of the annular body is to hold in place the self-expanding member. In some embodiments, the distal holder 116 comprises an attachment member 120, which runs in an independent tube 122 inside the hollow tube 106. In some embodiments, the proximal holder 118 is attached at the distal end of an inner tube 124, which runs inside the hollow tube 106 and separated from tube 122. In some embodiments, the dimensions of the distal holder 116 and the dimensions of the proximal holder 118 are the same. In some embodiments, the dimensions of the distal holder 116 and the dimensions of the proximal holder 118 are different. In some embodiments, the outer diameter over the protrusions of the annular body 200 of distal holder 116 and proximal holder 118 may be, between 0.4 mm and 0.9 mm, between 0.5 mm and 0.7 mm, between 0.3 mm and 1 mm, or intermediate, larger or smaller ranges. In some embodiments, the outer diameter of the annular body 200 of distal holder 116 and proximal holder 118 may be, between 90% and 98% of the outer diameter over the protrusions of the annular body 200 of distal holder 116 and proximal holder 118, between 85% and 95%, between 75% and 90%, between 70% and 98%, or intermediate, larger or smaller percentages of the outer diameter over the protrusions of the annular body 200 of distal holder 116 and proximal holder 118. In some embodiments, the number of axial rows of protrusions of the annular body 200 of distal holder 116 and proximal holder 118 may be, between 1% and 40% of the length of self-expanding member 114 in the stretched reduced diameter loaded to elongate device 104, between 1% and 5%, between 10% and 15%, between 20% and 25%, or intermediate, larger or smaller percentages of the length of self-expanding member 114 in the stretched reduced diameter loaded to elongate device 104.

In some embodiments, one or more radiopaque markers are incorporated in the self expanding member and/or in the tubes and/or in the cap and/or in the microcatheter, to visualize the components under imaging, such as under fluoroscopy. In an example, one or more radiopaque wires are incorporated in the mesh of the self-expanding member. Optionally, the wire is made of tantalum. Alternatively, a wire is a clad with a radiopaque material. Additionally or alternatively, markers in the form of an elongated line, ring, dot, and/or any other configuration are incorporated in the device. In some embodiments, markers are positioned to facilitate aligning a denser wall portion or segment of the self-expanding member with the aneurysm neck. In some embodiments, the markers are configured at a periphery of the dense segment. In an example, if the dense segment is configured between two less-dense segments, the markers may align the borderline between the segments. In another example, markers are configured at one or more locations of the dense portion, for example at a center point of the dense portion. In some embodiments, one or more markers are positioned to indicate the proximal and/or distal ends of the member.

Exemplary materials from which the device components are made of may include: hollow tube 106 comprising metal, plastic, or a combination thereof, having stiffness properties suitable for being passed within the cerebral vasculature (and/or other vasculature); cap 108 comprising metal, plastic, or a combination thereof, having stiffness properties suitable for being passed within the cerebral vasculature (and/or other vasculature); central wire 112 comprising metal; tubular member 112 comprising plastic, metal, or a combination thereof; self-expanding member 114 comprising wires comprising a resilient material, optionally substantially elastic or super elastic alloy, such as nickel-titanium alloy or stainless steel, or a mixture of different metals (e.g. 15 Ni-Ti wires and Platinum-Tungesten); distal 116 and proximal 118 holders comprising metal, plastic, ceramic or a combination thereof; member 120 comprising plastic, metal, or a combination thereof; inner tube 124 comprising metal, plastic, or a combination thereof; tube 122 comprising metal, plastic, or a combination thereof. EXEMPLARY METHOD

Figs. 3a-f illustrate a flowchart of an exemplary method 300 for occluding the neck of an aneurism using the device of FIG. 1. In some embodiments, the method begins by bringing the microcatheter close to the location of the aneurism 302. In some embodiments, the method continues by opening the elongate device 304 thereby exposing the internal mechanism to the environment. Then, in some embodiments, the user assesses the location of the internal mechanism in relation to the neck of the aneurysm 306. Then, in some embodiments, the user causes the self-expanding member to bend outwardly towards the neck of the aneurysm 308. In some embodiments, the user then assesses the location of the self-expanding member on the neck 310. At this point, in some embodiments, there can be two possibilities: either the self-expanding member in the correct position or it is not 312. If the self-expanding member is not in the right position, then the user, in some embodiments, will return the self-expanding member to its original un-bent configuration 314, and try again to assess the location of the internal mechanism in relation to the neck of the aneurysm (back to 306). If the self-expanding member is in the right position, then the user, in some embodiments, will release the distal end of the self-expanding member 318. Following this, in some embodiments, the user will release the proximal end of the self-expanding member 320. Finally, the user can extract the elongate device and microcatheter from the user 322, concluding the exemplary method 324.

In some embodiments, opening the elongate device 304 is performed by doing the following (continue at circle A 326 in Fig. 3b): pushing the tubular member 112 while holding the hollow tube 106 in place (328).

In some embodiments, causing the self-expanding member to bend outwardly 308 is performed by doing the following (continue at circle B 330 in Fig. 3c): pulling the tubular member 112 while holding the hollow tube 106 and attachment member 120 in place (332).

In some embodiments, returning the self-expanding member to its original configuration 314 is performed by doing the following (continue at circle C 334 in Fig. 3d): pushing the tubular member 112 while holding hollow tube 106 and attachment member 120 in place (336).

In some embodiments, releasing the distal end of the self-expanding member 318 is performed by doing the following (continue at circle D 338 in Fig. 3e): pulling the attachment member 120 (340), actuate the distal holder 116 (342); pushing tubular member 112 (344); then the distal end of the self-expanding member is released (346).

In some embodiments, releasing the proximal end of the self-expanding member 320 is performed by doing the following (continue at circle E 348 in Fig. 3f): actuate the proximal holder 118 (350); keeping the inner tube 124 from moving while pulling the hollow tube 106 (352); then the proximal end of the self-expanding member is released (354).

Referring now to Figs. 4a-i, showing the exemplary method in figures so as to facilitate the understanding of the exemplary method and the correlation between the device and the method.

Fig. 4a shows bringing the microcatheter close to the location of the aneurism 402 and opening the elongate device so as to expose the internal mechanism to the environment. Fig. 4b shows how the pulling of the wire or tubular member 112 proximally causes the attachment member 120 to fold outwards in relation to the central core of the device and pushes the self expanding member 114 into the correct direction which is towards the walls of the vessel and/or the neck of the aneurism. In this case, the self-expanding member 114 is not in the right location. Fig. 4c shows how when user pushes the central wire or tubular member 112 without moving the hollow tube 106, the self-expanding member 114 returns at its original position and ready to try again. Fig. 4d shows that the user moved the device to a different position. Fig. 4e shows another attempt of the user to position the self-expanding member in the correct position. This time, the user succeeds and the self-expanding member is located at the right position. Fig. 4f shows how the user pulls the attachment member 120, locking the movement of the internal mechanism. Fig. 4g shows that, after the actuation of the distal holder 116, therefore releasing the attachment of the distal end of the self-expanding member 114 to the distal holder 116, the user pushes the wire or tubular member 112 while holding everything else steady. This causes the cap 108 to move forward and allow the distal end of the self-expanding member to gently be released. Fig. 4h shows that, after the actuation of the proximal holder 118, therefore releasing the attachment of the proximal end of the self-expanding member 114 to the proximal holder 118, the user pulls the hollow tube 106 while holding everything else steady. This enables the proximal end of the self expanding member to gently be released. Lastly, Fig. 4i shows the exiting of the device from the body of the patient and the self-expanding member completely placed at the correct location.

In some embodiments, a dense wall portion of the self-expanding member, for example defining a central axial segment of the self-expanding member, is a positioned to align at least 80%, 90%, 95%, 100% or intermediate, larger or smaller percentages of an axial length of the aneurysm neck, to substantially block the aneurysm. In some embodiments, blocking comprises reducing blood flow such as radial blood flow to and/or flow the aneurysm. In some embodiments, blocking comprises preventing one or more coils that were introduced into the aneurysm from exiting the aneurysm. In some embodiments, a wall portion of the self-expanding member extends across the neck of aneurysm, substantially blocking radial flow such as flow of blood into and/or out of the aneurysm. Optionally, the flow is obstructed due to openings in the self-expanding member being small enough and/or arranged with respect to each other to define a high density wall portion through which flow cannot pass, or at least a substantial amount of flow is obstructed. In some embodiments, a certain flow volume is allowed to flow into and/or out of the aneurysm, as long as the flow rate is slowed down to rate sufficient for a thrombotic reaction to take place to eventually seal the aneurysm. For example, the flow rate is reduced to a rate lower than the coagulation rate of blood. In some embodiments, the coagulation dynamics of a specific patient are monitored, and the self-expanding member is adjusted and/or readjusted according to the flow dynamics. For example, the diameter of the member or one or more portions thereof may be reduced when sufficient sealing of the aneurysm is observed. Additionally or alternatively, the flow is slowed down enough to prevent rupture of the aneurysm. In some embodiments, flow dynamics are assessed using various techniques, such as injecting contrast media to be seen in the imaging system (x-ray, CT, angio-CT, MRI, etc.) to determine whether the position the member and/or extent of expansion of the member are suitable to sufficiently reduce a volume of the flow to and/or from the aneurysm.

In some embodiments, a size of an opening defined at a wall portion of the self-expanding member is small enough to prevent from one or more coils, which were introduced into aneurysm, from exiting the aneurysm. In an example, a cross sectional area of the opening ranges between 0.1mm^A2 to lmm^A2, or intermediate, larger or smaller ranges. This may provide an advantage in cases in which a ratio between a diameter of the aneurysm (for example at the widest portion of the aneurysm) and a diameter of the neck of the aneurysm is relatively small, for example smaller than 0.8, smaller than 0.5, smaller than 0.3 or intermediate, larger or smaller ratios, and a risk of coils exiting the aneurysm is higher than cases in which the neck portion is narrower (i.e. comprises a smaller diameter), which is effective to stop the coils from entering the blood vessel.

In some embodiments, the openings of the self-expanding member comprise a cross sectional area which is smaller than a maximal cross sectional area of curled-up coil, in its non- planar form. Optionally, the cross sectional area of opening is large enough to allow the coil to pass through when the coil is in a straightened, linear configuration, but small enough to prevent the coil from passing through when the coil has clumped into a non-linear form, inside the aneurysm. Optionally, the openings are large enough to allow a coil-delivering microcatheter to pass through, and small enough to prevent a coil that was released from the microcatheter and curled-up in the aneurysm from passing back through.

In some embodiments, the self-expanding member does not obstruct non-radial flow through the blood vessel, such as axial flow. Optionally, the flow passes through the proximal and distal ends of the member.

As used herein the term“about” refers to ±20% of the specified quantity.

The terms "comprises", "comprising", "includes", "including", “having” and their conjugates mean "including but not limited to".

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

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

As used herein, the singular form "a", "an" and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" may include a plurality of compounds, including mixtures thereof.

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

Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases“ranging/ranges between” a first indicate number and a second indicate number and“ranging/ranges from” a first indicate number“to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.

Unless otherwise indicated, numbers used herein and any number ranges based thereon are approximations within the accuracy of reasonable measurement and rounding errors as understood by persons skilled in the art. As used herein the term "method" refers to manners, means, techniques and procedures for accomplishing a given task including, but not limited to, those manners, means, techniques and procedures either known to, or readily developed from known manners, means, techniques and procedures by practitioners of the chemical, pharmacological, biological, biochemical and medical arts.

As used herein, the term“treating” includes abrogating, substantially inhibiting, slowing or reversing the progression of a condition, substantially ameliorating clinical or aesthetical symptoms of a condition or substantially preventing the appearance of clinical or aesthetical symptoms of a condition.

It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.

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

All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting. In addition, any priority document(s) of this application is/are hereby incorporated herein by reference in its/their entirety.

Claims

WHAT IS CLAIMED IS:

1. A controlled self-expanding member deployment delivery device comprising:

a. a self-expanding member having a distal end and a proximal end;

2. The device of claim 1, wherein said proximal holder comprises:

a. a hollow tube;

b. an inner tube located inside said hollow tube; and

c. a first annular member comprising a plurality of protrusions externally attached to said inner tube.

3. The device of claim 1 or 2, wherein said first annular member comprising said plurality of protrusions of said proximal holder is configured to hold from inside said proximal end of said self-expanding member.

4. The device of anyone of claims 1-3, wherein said hollow tube of said proximal holder is configured to hold from outside said proximal end of said self-expanding member.

5. The device of any one of claims 1-4, wherein said distal holder comprises:

a. a distal cap;

b. a movable tubular member interconnected to said distal cap; and

6. The device of any one of claims 1-5, wherein said second annular member comprising protrusions of said distal holder is configured to hold from inside said distal end of said self expanding member.

7. The device of any one of claims 1-6, wherein said distal cap is configured to hold from outside said distal end of said self-expanding member.

8. The device of any one of claims 1-7, wherein said tubular member extends proximally from said distal cap, inside said inner tube, to an operator controller.

9. The device of any one of claims 1-8, wherein said cap is atraumatic.

10. The device of any one of claims 1-9, wherein said cap comprises a diameter from about 0.4 mm and 0.7 mm.

11. The device of any one of claims 1-10, wherein said plurality of protrusions are configured to be inserted in openings of said self-expanding member.

12. The device of any one of claims 1-11, wherein an outer diameter over said plurality of protrusions is between 0.4 mm and 0.9 mm.

13. The device of any one of claims 1-12, wherein said first and second annular members comprise an annular member outer diameter between 70% and 98% of said outer diameter.

14. The device of any one of claims 1-13, wherein a number of axial rows of said protrusions of said first and said second annular bodies are between 1% and 40% of the length of said self expanding member in a stretched reduced diameter when loaded in said device.

15. The device of any one of claims 1-14, wherein said deployment delivery device is sized to be slidably disposed within a microcatheter having a diameter from about 0.5mm to about 4mm.

16. The device of any one of claims 1-15, wherein said cap comprises a diameter at least 20% smaller than the internal diameter of said microcatheter.

17. The device of any one of claims 1-16, wherein said distal holder comprises an attachment member, which enables controllable distal/proximal movements of said distal holder by a user.

18. The device of any one of claims 1-17, wherein said attachment member optionally runs in an independent tube inside said hollow tube.

19. The device of any one of claims 1-18, wherein said attachment member is a round or flattened wire.

20. The device of any one of claims 1-19, wherein said self-expanding member is a memory shape self-expanding member.

21. The device of any one of claims 1-20, wherein said inner tube is a movable inner tube configured to move distally and proximally.

22. The device of any one of claims 1-21, wherein instead of said plurality of protrusions said first annular member comprises a textured surface externally attached to said inner tube.

23. The device of any one of claims 1-22, wherein instead of said plurality of protrusions said first annular member comprises an elastic member externally attached and squeezed into said inner tube.

24. The device of any one of claims 1-23, wherein instead of said plurality of protrusions said first annular member comprises a friction surface externally attached to said inner tube.

25. The device of any one of claims 1-24, wherein said first annular member and said inner tube are a single component.

26. A method for controlled deployment of a self-expanding member, comprising:

c. adjusting at least one axial position of said self-expanding member;

d. releasing said distal end;

e. releasing said proximal end.

27. The method of claim 26, wherein said adjusting at least one axial position of said self expanding member further comprises bending outwardly a part of said self-expanding member towards a desired location for said deployment.

28. The method of claim 26 or 27, wherein said bending outwardly comprises at least one selected from the group consisting of:

a. axially moving said distal towards said proximal end;

b. axially moving said proximal end towards said distal end;

29. The method of any one of claims 26-28, wherein said bending outwardly comprises not deforming said self-expanding member.

30. The method of any one of claims 26-29, wherein when said part of said self-expanding member is not located at said desired location, then straightening inwardly said self-expanding member to its original configuration.

31. The method of any one of claims 26-30, wherein straightening inwardly said self-expanding member comprises at least one selected from the group consisting of:

a. axially moving said distal away from said proximal end;

b. axially moving said proximal end away from said distal end;

32. The method of any one of claims 26-31, wherein said constraining a distal end comprises constraining said distal end between a cap and a distal holder.

33. The method of any one of claims 26-32, wherein said constraining a proximal end comprises constraining said proximal end between a hollow tube and a proximal holder; said proximal holder located on an internal tube, said internal tube contained inside said hollow tube.

34. The method of any one of claims 26-33, wherein said releasing said distal end comprises moving distally said cap.

35. The method of any one of claims 26-34, wherein said releasing said distal end comprises moving proximally said distal holder.

36. The method of any one of claims 26-35, wherein said releasing said proximal end comprises moving proximally said hollow tube.

37. The method of any one of claims 26-36, wherein said releasing said proximal end comprises moving distally said proximal holder.

38. A method of positioning a controlled self-expanding member in proximity to an aneurysm neck, comprising:

a. bringing a device comprising said controlled self-expanding member in close proximity with said aneurysm neck, said controlled self-expanding member comprising a distal end and a proximal end, said device comprising a proximal holder configured to hold said proximal end from both inside and outside thereof and a distal holder configured to hold said distal end from both inside and outside thereof;

b. positioning said controlled self-expanding member at a desired location;

c. bending outwardly a central part of said self-expanding member;

d. assessing location of said central part of said self-expanding member;

f. when location is incorrect, then straightening inwardly said central part of said self expanding member and perform“c”.

39. The method of claim 38, wherein said bending outwardly a central part of said self-expanding member comprises not deforming said self-expanding member.

40. The method of claim 38 or 39, wherein said bending outwardly comprises at least one selected from the group consisting of:

a. axially moving said distal towards said proximal end;

b. axially moving said proximal end towards said distal end;

41. The method of any one of claims 38-40, wherein said straightening inwardly said central part of said self-expanding member comprises at least one selected from the group consisting of: a. axially moving said distal away from said proximal end;

b. axially moving said proximal end away from said distal end;