Adjustable constrictor for reducing the diameter of implantable medical device

Abstract

A medical device for implantation in a blood vessel, with an adjustable diameter, comprising a deformable tubular wall, and a constrictor, comprising a filament, comprises a plurality of radially protruding sections, and a hollow lock, comprises an inner lumen, wherein the filament is inserted to the inner lumen of the hollow lock and a portion of the filament is mechanically coupled to the hollow lock, forming a closed shape, wherein the constrictor surrounds circumferentially at least a portion of the deformable tubular wall.

Description

[0001] ADJUSTABLE CONSTRICTOR FOR REDUCING THE DIAMETER OF IMPLANTABLE MEDICAL DEVICE

[0002] RELATED APPLICATION / S

[0003] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 602,459 filed on November 24, 2023, the contents of which are incorporated herein by reference in their entirety.

[0004] FIELD AND BACKGROUND

[0005] The present invention, in some embodiments thereof, relates to a constrictor for reducing the effective diameter of a portion of an implantable medical device and, more particularly, but not exclusively, to an adjustable constrictor for reducing the effective diameter of an implantable for positioning within a blood vessel.

[0006] U.S. Patent Application No. 20180085128 discloses “Methods and medical apparatus for deployment within an anatomical blood vessel. The medical apparatuses comprising: a first tubular wall, a second tubular wall, within the first tubular wall, and a constricting element configured to constrict a circumference of a portion of the second tubular wall; the combination of the first tubular wall, the second tubular wall and the constricting element forms a diametrical reducer.” (abstract).

[0007] U.S. Patent Application No. 20210169667 discloses “A diametric adjustment mechanism for an implantable medical device including a track defining a series of diametric setpoints, including a first diametric setpoint and a second diametric setpoint, a rider engaged with the track such that the rider is selectively movable along the track from the first diametric setpoint to the second diametric setpoint and from the second diametric setpoint to the first diametric setpoint, and a biasing element biasing the rider toward the first diametric setpoint when the rider is at the second diametric setpoint.” (abstract).

[0008] U.S. Patent Application No. 20220257395 discloses “A fully absorbable stent for treating lesions in vessels in the body has a flexible covering and expandable belts. The device is formed from very low inflammation response materials that are fully absorbed in 3 to 12 months. The expandable belts provide radial forces for keeping the vessel open following balloon angioplasty.” (abstract).

[0009] International Patent Application No. 2021226014 discloses “Disclosed are vascular flow modulators generally comprised of an expandable scaffold with built-in adjustability to modulate hemodynamic output inside a vessel, for instance, the coronary sinus. Methods of placing and adjusting disclosed flow modulators are also disclosed.” (abstract). International Patent Application No. 2002113109 discloses “PROBLEM TO BE SOLVED: To provide a medical instrument capable of suppressing an invasion to a patient to a minimum for medical treatment and forming the fistulous opening of large diameter on a human body. SOLUTION: A main body 1 of sheath is formed almost cylindrical by being wound plural times from one end of the long side of a synthetic resin rectangular thin plate. Besides, a diameter reduction preventing mechanism is arranged at each of both the terminal parts of the long side or closely thereto.” (abstract).

[0010] U.S. Patent Application No.20050055082 discloses “A flow reducing implant for reducing blood flow in a blood vessel having a cross sectional dimension, the flow reducing implant comprising a hollow element adapted for placement in the blood vessel defining a flow passage therethrough, said flow passage comprising at least two sections, one with a larger diameter and one with a smaller diameter, wherein said smaller diameter is smaller than a cross section of the blood vessel. A plurality of tabs anchor, generally parallel to the blood vessel wall, are provided in some embodiments of the invention.” (abstract).

[0011] SUMMARY

[0012] 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.

[0013] Example 1. A medical device for implantation in a blood vessel, with an adjustable diameter, comprising;

[0014] (a) a deformable tubular wall; and

[0015] (b) a constrictor, comprising:

[0016] (i) a filament, comprises a plurality of radially protruding sections; and

[0017] (ii) a hollow lock, comprises an inner lumen, wherein the filament is inserted to the inner lumen of the hollow lock and a portion of the filament is mechanically coupled to the hollow lock, forming a closed shape, wherein the constrictor surrounds circumferentially at least a portion of the deformable tubular wall.

[0018] Example 2. A medical device for implantation in a blood vessel, according to example 1, wherein there is a geometric interference to the passage of the plurality radially protruding sections through the inner lumen of the hollow lock, and at least one of the filament and hollow lock is formed from a material that upon sufficient applied force pulling the filament can reversibly deform to allow the passage of the filament trough the hollow lock.

[0019] Example 3. A medical device for implantation in a blood vessel, according to example 1, wherein the radially protruding sections are bent sections of the filament.

[0020] Example 4. A medical device for implantation in a blood vessel, according to example 3, wherein the bent sections have a triangular shape.

[0021] Example 5. A medical device for implantation in a blood vessel, according to any of examples 1-4, wherein the filament comprises Nitinol, and wherein the Nitinol is pre-treated to include the radially protruding sections.

[0022] Example 6. A medical device for implantation in a blood vessel, according to any of examples 1-5, wherein the diameter of the filament is sufficiently small for pre-treatment, including bending, to result in radially protruding sections, and sufficiently large for avoiding breakage of the filament when straightened through the hollow lock.

[0023] Example 7. A medical device for implantation in a blood vessel, according to any of examples 1-7, wherein the diameter of the filament is between 0.1-0.3 mm.

[0024] Example 8. A medical device for implantation in a blood vessel, according to any of examples 1-4, wherein the radially protruding sections have a radial extent greater than the inner lumen of the hollow lock.

[0025] Example 9. A medical device for implantation in a blood vessel, according to any of examples 1-8, wherein at least one of the filament and hollow lock are deformable.

[0026] Example 10. A medical device for implantation in a blood vessel, according to any of examples 1-9, wherein the radially protruding sections are steeper in one axial direction along the filament than in an opposite axial direction along the filament.

[0027] Example 11. A medical device for implantation in a blood vessel, according to any of examples 1-10, wherein the required force for passing the filament through the hollow lock is different for movements in one relative direction compared to relative movement in an opposite direction.

[0028] Example 12. A medical device for implantation in a blood vessel, according to example 11 wherein the force is greater for reducing the constriction.

[0029] Example 13. A medical device for implantation in a blood vessel, according to any of examples 1-12 wherein the hollow lock comprises a rounded rim at an entrance of the filament thereto.

[0030] Example 14. A medical device for implantation in a blood vessel, according to example 13, wherein said inner lumen has with a fixed inner diameter.

[0031] Example 15. A medical device for implantation in a blood vessel, according to example 13, wherein said inner lumen has a non-uniform inner cross-section. Example 16. A medical device for implantation in a blood vessel, according to any of examples 1-15, wherein at least one radially protruding section comprises a thickening of the filament.

[0032] Example 17. A medical device for implantation in a blood vessel, according to example 16, wherein the thickening is symmetric around the filament axis.

[0033] Example 18. A medical device for implantation in a blood vessel, according to any of examples 1-17, wherein said mechanical coupling comprises geometric interference between a thickening of the filament and the inner lumen.

[0034] Example 19. A medical device according to example 18, wherein said thickening comprises a spherical shape.

[0035] Example 20. A medical device for implantation in a blood vessel, according to any of examples 1-19, wherein said lock is elongate and aligned with said filament around a circumference of said tubular wall.

[0036] Example 21. A medical device for implantation in a blood vessel, according to example 19, wherein said lock is has a maximal outer diameter of less than 1 mm, a maximal inner diameter of less than 0.5 mm, and said filament has an outer diameter of less than 0.25 mm.

[0037] Example 22. A medical device for implantation in a blood vessel, according to any of examples 1-21, comprising at least one stopper positioned at the end of said filament.

[0038] Example 23. A medical device for implantation in a blood vessel, according to example 22, wherein said at least one stopper comprises two stoppers, each positioned at another end of said filament.

[0039] Example 24. A medical device for implantation in a blood vessel, according to example 23, wherein one stopper of said two stoppers is fixed to said lock.

[0040] Example 25. A medical device for implantation in a blood vessel, according to any of examples 22-24, wherein the at least one stopper of said at least one stopper comprises a spherical shape having a diameter larger than the opening of the lock.

[0041] Example 26. A medical device for implantation in a blood vessel, according to any of examples 22-24, wherein the at least one stopper is shaped to radially protrude more in one or more radial directions than in one or more other radial directions.

[0042] Example 27. A medical device for implantation in a blood vessel, according to example 26, wherein the one or more other radial directions are facing an adjacent portion of the filament, Example 28. A medical device for implantation in a blood vessel, according to any of examples 22-24, or 26-27, wherein at least one stopper of said at least one stopper comprises an oblong shape having a length larger than the opening of the lock and a width larger than the diameter of the filament and smaller than the opening of the lock. Example 29. A medical device for implantation in a blood vessel, according to any of examples 22-24, or 26-27, wherein the at least one stopper comprises a missing segment, configured to expose a portion of the filament passing through the stopper. Example 30. A medical device for implantation in a blood vessel, with an adjustable diameter, comprising;

[0043] (a) a deformable tubular wall; and

[0044] (b) a constrictor, comprising:

[0045] (i) a filament; and

[0046] (ii) a hollow lock, comprises an inner lumen with at least one narrowed section, wherein the filament is inserted into the inner lumen of the hollow lock and a portion of the filament is mechanically coupled to the hollow lock, forming a shape, surrounding circumferentially at least a portion of the deformable tubular wall.

[0047] Example 31. A medical device for implantation in a blood vessel, according to example 30, wherein the diameter of the filament is larger than the diameter of the at least one narrowed section.

[0048] Example 32. A medical device for implantation in a blood vessel, according to example 30, wherein the filament comprises radially protruding sections which a diameter larger than the diameter of the at least one narrowed section, while said filament between said sections has a diameter smaller than that of said narrow section.

[0049] Example 33. A medical device for implantation in a blood vessel, according to example 24, wherein said radially protruding sections are deformable.

[0050] Example 34. A medical device for implantation in a blood vessel, according to any of examples 30-33, wherein at least one of the filament and hollow lock are deformable.

[0051] Example 35. A medical device for implantation in a blood vessel, according to example 22, wherein the narrowed inner lumen obstructs the passage of the filament through the hollow lock.

[0052] Example 36. A medical device for implantation in a blood vessel, according to any of examples 30-35, wherein the reduced inner lumen includes axially separated narrowed sections.

[0053] Example 37. A medical device for implantation in a blood vessel, according to any of examples 30-36, wherein the reduced inner lumen is defined by one or more intrusions of a wall of said hollow lock into said inner lumen.

[0054] Example 38. A medical device for implantation in a blood vessel, with an adjustable diameter, comprising:

[0055] (a) a deformable tubular wall; and

[0056] (b) a constrictor, comprising: a filament, tied in the form of a sliding knot having a loop movable along the filament by pulling on ends of the filament, forming a shape, surrounding circumferentially at least a portion of the wall.

[0057] Example 39. A method of controlling the diameter of a deformable tubular wall of a medical implant, comprising

[0058] (a) pulling on a filament surrounding said tubular wall with sufficient force to deform one or both of said filament and hollow lock to allow relative movement therebetween and a hollow lock mounted on said filament and insufficient to dislodge said medical implant;

[0059] (b) releasing said filament to allow the medical implant to rest in a new, more constricted shape; and

[0060] (c) repeating said (a) and (b).

[0061] Example 40. A method according to example 39, comprising pushing said filament towards said implant, with sufficient force to provide relative movement between said filament and said hollow lock in a direction opposite to (a).

[0062] Example 41. A method according to example 39, comprising increasing an inner diameter of said deformable tubular wall by expanding an expansion device inside said wall with sufficient pressure to cause relative movement between said filament and said hollow lock in a direction opposite to (a).

[0063] Example 42. A method according to example 41, wherein the expansion device is a noncomplaint medical balloon.

[0064] Example 43. A method according to example 41 or example 42, wherein the increasing comprises increasing in steps due to modulated resistance of said hollow lock to movement of said filament.

[0065] Example 44. A method according to any of examples 39-43, wherein said pulling causes a straightening of at least one bent section in said filament adjacent or in said hollow lock.

[0066] Example 45. A method according to any of examples 39-44, wherein (c) defines step-wise movement due to said pulling being characterized by modulated resistance of said hollow lock to movement of said filament.

[0067] Example 46. A kit for gradually expanding the effective diameter of a deformable tubular wall comprising a plurality ofat least one noncompliant balloon, s wherein the plurality of noncompliant balloons comprises more than one noncompliant balloon of different inflated diameters.

[0068] Example 47. A kit according to example 46, comprises instructions on how to use the noncompliant balloon to achieve a specific diameter. Example 48. A kit according to examples 47 or 46, wherein the instructions comprise a specification of at least one atmospheric pressure required to achieve at least one specific diameter.

[0069] Example 49. A kit according to example 46, wherein the at least one noncompliant balloon is a plurality of noncompliant balloons of different inflated diameters.

[0070] Example 50. A method for gradually expanding the effective diameter of a deformable tubular wall having a constrictor mounted thereon, by using a kit of noncompliant balloons, wherein the deformable tubular wall comprises a wall and an inner lumen having an initial effective diameter, wherein the method comprises: a) inserting a first noncompliant balloon into the lumen, having a first inflated diameter; b) inflating the first noncompliant balloon within the lumen, wherein the first inflated diameter is larger than the initial effective diameter of the lumen, and wherein the first noncompliant balloon is applying pressure onto the wall of said deformable wall from within the lumen, to deform the wall and partially open the constrictor to obtain a second effective diameter of the lumen, wherein the second effective diameter is larger than the initial effective diameter. c) inserting a second noncompliant balloon into the lumen, having a second inflated diameter larger than the first inflated diameter of the first noncompliant balloon; d) inflating the second noncompliant balloon within the lumen.

[0071] Example 51. A method according to example 50, wherein the method further comprises repeating steps c-d at least one time, wherein the repeating comprises inserting a noncompliance balloon with an inflated diameter larger than a previous noncompliance balloon.

[0072] Example 52. A method according to any of examples 50-51, wherein the constrictor is according to any of examples 1-30.

[0073] Example 53. A method according to any of examples 50-52, wherein the kit is according to example 38.

[0074] 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. BRIEF DESCRIPTION OF THE DRAWINGS

[0075] 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.

[0076] Similar elements may have the same number, advanced by multiples of 100.

[0077] In the drawings:

[0078] FIG. 1 shows an adjustable constrictor, mounted on an implantable medical device, such as a deformable tubular wall, in accordance with some exemplary embodiments of the invention;

[0079] FIG. 2 shows a front view of an adjustable constrictor for reducing the effective diameter of an implantable medical device, such as a deformable tubular wall, in accordance with some exemplary embodiments of the invention;

[0080] FIG. 3 shows an adjustable constrictor mounted on deformable tubular wall, deployed within a blood vessel, in accordance with some exemplary embodiments of the invention;

[0081] FIG. 4 shows a schematic illustration of a constrictor comprising a filament with radially projecting sections, in accordance with some exemplary embodiments of the invention;

[0082] FIG. 5 shows a fragmentary view of a constrictor comprising a bent Nitinol wire, in accordance with some exemplary embodiments of the invention;

[0083] FIG. 6 shows a fractional view of a constrictor comprises a Nitinol wire having radially prominent sections, in accordance with some exemplary embodiments of the invention;

[0084] FIG. 7A is a fragmentary view of a cross-section of a constrictor comprising a lock having a radial narrowing, in accordance with some exemplary embodiments of the invention;

[0085] FIG. 7B is a fragmentary, perspective view of a constrictor comprising a lock having a radial narrowing, in accordance with some exemplary embodiments of the invention;

[0086] FIG. 8 shows a fractional view of a constrictor comprising a lock having radial narrowing and filament comprising altering sections of relatively high and low interference to passage through the lock, in accordance with some exemplary embodiments of the invention;

[0087] FIGs. 9A-C show a perspective view of a constrictor comprising a filament with a sliding knot, mounted on an implantable medical device, in accordance with some exemplary embodiments of the invention;

[0088] FIG. 9D shows an example of a sliding knot and an exemplary method for tying thereof, in accordance with some exemplary embodiments of the invention; FIG. 10 shows a flow chart of a method for constricting the effective diameter of an implantable device, using a constrictor, in accordance with some exemplary embodiments of the invention;

[0089] FIGs. 11A-B show perspective views of a constrictor comprising at least one stopper having at least one radial protruding direction that protrudes more than at least one other radial directions, in accordance with some exemplary embodiments of the invention;

[0090] FIG. 11C shows a front view of a constrictor comprising at least one stopper having at least one radial protruding direction that protrudes more than at least one other radial directions, in accordance with some exemplary embodiments of the invention;

[0091] FIG. 12 shows a perspective view of a stopper having at least one radial protruding direction that protrudes more than at least one other radial directions, in accordance with some exemplary embodiments of the invention;

[0092] FIG. 13A shows a perspective view of a constrictor comprising at least one stopper, a filament attached to the stopper such that the stopper exposes a portion the filament, in accordance with some exemplary embodiments of the invention;

[0093] FIG. 13B shows a fractional side view of a constrictor comprising at least one stopper, a filament attached to the stopper such that the stopper exposes a portion the filament, in accordance with some exemplary embodiments of the invention.

[0094] FIGs. 13C-D, show perspective views of a stopper that exposes a portion of the filament attached thereto, in accordance with some exemplary embodiments of the invention

[0095] DESCRIPTION OF SPECIFIC EMBODIMENTS OF THE INVENTION

[0096] The present invention, in some embodiments thereof, relates to a constrictor for reducing the effective diameter of an implantable medical device and, more particularly, but not exclusively, to an adjustable constrictor for reducing the effective diameter of an implantable medical device, for positioning within a blood vessel.

[0097] An aspect of some embodiments of the invention relates to an adjustable one-dimensional diameter reducer for reducing the effective diameter of an implantable medical device, which optionally changes size in steps, when adjusted. The term 'diameter reducer' is also referred to in this application as a 'constrictor,' which is configured to restrict or regulate the flow through the implantable medical device. This diameter reducer has the potential advantage of occupying less space on the implantable medical device along a longitudinal axis of the device, while allowing controlled adjustment in steps. Potentially, this diameter reducer defines a thin narrowing on the implantable medical device, having the potential advantage to fit on a short implantable device, intended for short implantation sites (e.g., as in the pulmonary artery). Potentially, this adjustable one-dimensional diameter reducer has relatively high twisting ability and / or flexibility together with the ability to be adjusted in steps, which can be beneficial when threaded through a wall of an implantable medical device and / or for tight contact with the implantable medical device. While it is noted that no physical object can be truly one dimensional, if a filament with a generally rectangular or circular cross-section is used, for example, with a diameter of less than 1mm, the filament (and diameter reducer) may be essentially one dimensional. This may be contrasted with ribbons or bands, for example, or other structures with a ratio of above 1:1.2 or 1:1.5 between a minimal diameter and a maximal diameter.

[0098] In some embodiments of the invention the diameter reducer is assembled from a thin extended elongated element passing through a passageway (e.g., inner lumen). A geometric interference to movement of the thin extended elongated element passing through the passageway may provide selective locking in place of the filament.

[0099] An aspect of some embodiments of the inventions relates to a diameter reducer (e.g., constrictor) comprises a thin extended elongated element (e.g., filament) passing through a passageway (e.g., of a lock), whereas the thin extended elongated element comprises radial extensions larger than a diameter of the passageway, for example, larger than the entrance to the passageway. These radial extensions interfere with the movement of the thin extended elongated element within the passageway.

[0100] In some embodiments of the invention, at least one of the radial extensions and / or the thin extended elongated element and / or the passageway wall is elastic and or / deformable. When a sufficient force is applied at least one of the radial extensions and / or the thin extended elongated element and / or the passageway, changes the shape thereof so that the thin extended elongated element including the radial extensions fit through the passageway. For example, the force may be applied axially by pulling on the elongate element.

[0101] When the force is released, the radial extensions optionally return to their original shape. The passage of the extended elongated element through the passageway is again obstructed by a radial extension.

[0102] The number of radial extensions along the thin extended elongated element is optionally used to define a plurality of locking positions, for example, 2, 3, 4, 5, 7, 10 such positions. The distance between positions can be, for example, 1mm, 2mm, 3mm, 4mm, 5mm and / or intermediate or larger or smaller distances. An aspect of some embodiments of the inventions relates to a diameter reducer comprises a thin extended elongated element having plurality of radially extending bent sections, where the element fits through a passageway defined by an inner lumen of a hollow lock.

[0103] In some embodiments of the invention the thin extended elongated element is pre-treated to obtain the bent sections, radially extending from the body thereof. In some embodiments of the invention, the radial sections extend radially at least a factor of 1.5, 2, 3, 5, 10 or less or more or intermediate factors of an inner diameter of the passageway.

[0104] In the absence of an applied external force the bent section obstructs the thin extended elongated element from passing through the passageway. When a sufficient force is applied at least one of the bent sections or / and the passageway wall deforms to allow the passage of the extended elongated element through the passageway.

[0105] In some embodiments of the invention, when a sufficient force is applied, the bent sections straighten relative to the longitudinal axis of the thin extended elongated element. The level of bending decreases to a point where the bent section can enter and pass through the passageway. When the force is released, the bent sections restore their original shape and / or level of bending. The passage of the extended elongated element through the passageway is again obstructed by a bent section. Optionally, the hollow lock has a length of at most 300%, 200%, 100%, 90%, 50% or intermediate or larger or smaller percentages of the distance between bent sections. Such length may allow the hollow lock to stably sit between two bent sections. In other embodiments, stability is provided by the constricted medical device trying to expand and the geometrical interference between a bent section and the passageway preventing this. Such factors can also be used for other designs described herein.

[0106] The number of bent sections along the extended elongated element may define a plurality of locking positions.

[0107] An aspect of some embodiments of the invention relates to an adjustable one-dimensional diameter reducer that can be expanded and / or narrowed in steps. The diameter reducer is assembled from a thin extended elongated element that can pass through a passageway, in two opposite directions. In some embodiments of the invention, the force required for passing the extended elongated element through the passageway to increase the level of constriction is higher than the force required for passing the extended elongated element through a passageway to reduce the diameter reducer. In some embodiments, the ratio between the forces is different for different "stops". In some embodiments of the invention, the extended elongated element is bent to include asymmetrical bent sections relative to the radial axis. In some embodiments of the invention, the bent sections are shaped as triangular, having one side steeper than the other. In some embodiments of the invention, a thickening of the elongate element is provided in order to provide radially extending sections thereon, for example, such thickenings may be spherical. Optionally or additionally, the elongate element is flattened (e.g., by pinching) so it wider at some points, this width interfering with the passageway.

[0108] In some embodiments of the invention, the thin extended elongated element is formed from Nitinol. In some embodiments, the selection of the diameter of the Nitionl thin extended elongated element is fined-tuned to obtain radially extending sections such as bent sections. In some embodiments, the diameter of the thin extended elongated element, formed of Nitinol, is sufficiently small so that pre-treating thereof results in the formation of radially extending sections, such as bent sections. On the other hand, the diameter of the Nitinol thin extended elongated element has a limit beneath which reduction results in compromising the mechanical strength thereof.

[0109] As mentioned previously in this document, the significance of the small diameter of the extended elongated element lies in the ability of the diameter reducer to define a thin narrowing on the implantable medical device. Therefore, in some embodiments, the diameter of the Nitionil thin extended elongated element is fine tuned to be small as possible, while still maintaining the mechanical strength thereof, overall and taking into account pre-treatment, (for example, possible material loss to some extent).

[0110] An aspect of some embodiments of the invention relates to a diameter reducer which comprises a thin extended elongated element passing through a passageway with a reduced opening. The width of the extended elongated element is larger than the entrance to the reduced opening (or other narrowed section thereof). The reduced opening limits the movement of the extended elongated element therewithin. When a sufficient force is applied, the extended elongated element deforms to a reduced diameter that can pass through the passageway. In some embodiments of the invention, the extended elongated element includes alternating sections of different geometries, for example, radial extensions. The radial extensions are larger than the reduced opening of the passageway. In some embodiments of the invention, the extended elongated element can move freely through the passageway whereas the radial extensions are obstructed by the reduced opening. In the absence of sufficient external force, the radial extensions limit the movement of the extended elongated element through the passageway. Alternatively, or additionally, the extended elongated element has a diameter larger than the entrance to the narrowed section and includes apertures (e.g., slits or holes) which reduce the effective diameter of the extended elongated element, but support radial collapsing thereof. An aspect of some embodiments of the invention relates to a diameter reducer configured to withstand the external forces exerted thereon when mounted on a deployed medical device. The geometric interference to movement of the thin extended elongated element passing through a passageway maintains the pre-set reduction.

[0111] In some embodiments of the invention, the shape and / or size of the radial extensions and / or the level of deformability of the radial extensions and / or thin extended elongated element and / or passageway are such that naturally occurring external forces exerted thereon due to flow of blood through the constriction of the device positioned in a blood vessel are not sufficient to overcome the geometric interference.

[0112] In some embodiments of the invention, the level of bending and / or size of the bent sections and / or the level of deformability of the bent sections and / or passageway are selected so that the external forces exerted thereon are not sufficient to overcome the geometric interference.

[0113] In some embodiments of the invention, the level of restriction or a reduced opening of the passageway and / or the level of deformability of the passageway and / or thin extended elongated element are selected so that the external forces exert thereon are not sufficient to overcome the geometric interference.

[0114] An aspect of some embodiments of the invention relates to an adjustable one-dimensional diameter reducer comprising only a thin extended elongated element. This diameter reducer has the potential advantage of not including elements prone to corrosion. An additional potential advantage is that adjustability can be achieved without requiring a locking element, which may protrude toward the blood vessel and / or impair the uniformity of the diametrical reduction and / or otherwise affect the shape of the deformed medical implant.

[0115] Potentially, such a diameter reducer has relatively high twisting ability and / or flexibility together with the ability to be adjusted, which can be beneficial when threaded through a wall of an implantable medical device and / or for tight contact with the implantable medical device.

[0116] The thin extended elongated element is tied with at least one loop to include a knot, defining a passageway. The knot defines an adjustment mechanism by sliding the knot loop along the thin extended elongated element and / or passing the thin extended elongated element through the passageway. Sliding the loop in one direction for enlarging the reduced diameter, and in the opposite direction for further reducing thereof. In some embodiments of the invention, such a friction mechanism is used instead of a geometric interference mechanism. Optionally or additionally, the knot defines a non-linear passageway (e.g., including an inner protrusion or a bend), which provides geometrical interference with the inserted elongated element. In some embodiments of the invention, the diameter reducer can be tightened by pulling at least one tail at an end portion of the filament. In some embodiments of the invention, the diameter reducer can be loosened by inflating a medical balloon within the implantable medical device. In some embodiments of the invention, the filament is rigid enough that the diameter reducer can be loosened by pushing the at least one tail at an end portion of the filament. For example, while the operator holds the implantable device in one hand and pushes the filament with the other hand thereof.

[0117] An aspect of some embodiments of the invention relates to a set of expandable devices (such as a set of noncompliance balloons) for expanding a diameter reducer, mounted on an implantable medical device, in steps. In some embodiments, an expandable device is inflated within the implantable medical device, expanding the diameter reducer and thereby increasing the effective diameter of the implantable medical device. In some embodiments, the set comprises a plurality of expandable devices, each having a different size. In some embodiments, the plurality of expandable devices is used in ascending order of size for achieving a stepped expansion of the diameter reducer. Alternatively or additionally, if the required expansion is known, an expandable device from the set, having a specific size to achieve the required expansion, can be used.

[0118] In some embodiments, the structure of the diameter reducer defines continuous expansion so that the stepped expansion is a result of using the plurality of expandable devices in ascending order of size.

[0119] In some embodiments, the structure of the diameter reducer defines expansion in steps as well. In some embodiments, the different sizes of the expandable devices in the set are according to the stepped expansion defined by the structure of the diameter reducer. Alternatively or additionally the different sizes of the noncompliant balloons in the set define different expansion steps than the stepped expansion defined by the structure of the diameter reducer. For example, larger steps.

[0120] An aspect of some embodiments of the invention relates to a diameter reducer (e.g., constrictor), having a closed shape (e.g., loop), formed by two portions of an extended elongated element (e.g., filament) passing through a passageway.

[0121] At least one end of the extended elongated element comprises a movement-restricting mechanism (e.g., stopper) shaped to radially protrude more in one or more radial directions than in one or more other radial directions. This geometry is potentially obstructed from entering into the passageway while reducing and / or avoiding interference with an adjacent portion of the extended elongated element. In some embodiments, the at least one radially protruding direction is directed away from the adjacent portion of the extended elongated element.

[0122] In some embodiments, the at least one radially protruding direction is configured to potentially reduce and / or avoid the risk of the end of the extended elongated element entering the passageway, which could cause an unintended and / or undesired opening of the diameter reducer. Additionally, the stopper geometry is configured to potentially reduce and / or avoid the risk of the stopper entering the passageway and expanding it.

[0123] In some embodiments, the at least one radially protruding direction extends beyond the opening of the passageway. Optionally, the geometry comprises at least one dimension having a diameter larger than the passageway opening. This extension potentially allows the stopper to resist relatively higher forces applied on the diameter reducer. In some embodiments, this diameter is larger than 0.42 mm, for example, 0.2-0.4 mm, or 0.33-0.45, or 0.42-0.5 mm, or 0.5- 1 mm, or 0.4- 1.5mm or about 0.25 mm, or about 0.4 mm, or about 0.5 mm, or about 0.7 mm or lower or higher or intermediate ranges or diameters.

[0124] In some embodiments, the at least one radial protruding direction does not radially extend and / or does not substantially radially extend beyond the opening of the passageway. In some embodiments, the at least one radial protruding direction is equal to and / or substantially equal to the cross-sectional area of the passageway opening together with the cross-sectional area of the passageway walls. In some embodiments, since two portions of the elongated element pass through the passageway the effective passageway opening is reduced so that the diameter of the stopper can be smaller than the diameter of the passageway opening. These relatively less protruding configurations potentially interfere less and / or do not interfere with crimping the device for loading it into the delivery catheter. In addition, these configurations potentially reduce the protrusion of the geometry towards the vessel wall’s tissue, having the potential advantage of reducing the risk of irritation, damage, and / or injury to the vascular tissue. In some embodiments, this diameter is about 0.42-0.64 mm, for example, 0.42-0.6 mm, or 0.02-0.1 mm, or 0.1-0.7mm or about 0.4 mm, or lower or higher or intermediate ranges or diameters.

[0125] In some embodiments, the geometry is shaped to have a cross-section that is not symmetrical in all directions. In some embodiments, the geometry is shaped to have an oblong shape, having one dimension that is significantly longer (e.g., length) than the other (e.g., width).

[0126] In some embodiments, the at least one less radial protruding direction (e.g., shorter dimension), such as the width of an oblong shape, is sized and / or shaped to potentially reduce and / or avoid distortion of a portion of the elongated element adjacent to the stopper and / or interference with movement of this portion near the stopper. For example, the shorter dimension may be in contact with the elongated element (e.g., with an adjacent portion of the elongated element).

[0127] In another example, the shorter dimension may be in line with and / or facing the the adjacent portion of the elongated element.

[0128] In some embodiments, the short dimension is equal to, substantially equal to, and / or only slightly larger than the diameter of the extended element to potentially reduce protrusion toward the extended element. For example, in some embodiments, the at least one less radial protruding direction does not exceed twice the thickness (cross-sectional diameter) of the elongated element. For example, the at least one less radially protruding direction does not exceed 0.5x, 0.25x, or O.lx the diameter of the elongated element, or lower, or higher, or intermediate multiples of the diameter.

[0129] In some embodiments, the shorter dimension is about 0.25 mm, for example, 0.25-0.3 mm, or 0.2-0.5 mm, or 0.1-1 mm or about 0.22 mm, or lower or higher or intermediate ranges or diameters.

[0130] In some embodiments, each end of both ends of the elongated element comprises a stopper.

[0131] In some embodiments, the stopper is connected to an end of the elongated element, for example, welded, bonded, or mechanically fastened to it. This potentially allows for enhanced control over the size and / or shape of the stopper by separate manufacturing processes. In some embodiments, the stopper is welded to the extended element on one end of the stopper. In some embodiments, the elongated element is welded to one or more of: the outer surface of the stopper, the more proximal end of the stopper, and / or the more distal end of the stopper.

[0132] Altarneitvly or additionally, the stopper may be formed from the end of the elongated element, for example by fixing the end in a folded configuration. In some embodiments, the end of the elongated element may be shaped into a sphere, optionally by exposing it to laser pulses. In some embodiments, the sphere shape may be further modified to achieve an asymmetrical shape, such as an oblong shape. For example, the sphere may be further shaped to be more oblonged by heating and / or mechanically pressing it. Alternatively or additionally, the end of the elongated element may be directly shaped to have one radial direction that radially protrudes more than one or more other radial directions (e.g., an oblong shape). For example, by exposing the end of the elongated element to focused laser pulses, pressing the heated end into an oblong mold, mechanical grinding, controlled stretching during manufacturing, and / or localized heating and stretching of the end. In some embodiments, the stopper geometry is shaped such that the protruding direction (e.g., longer dimension) is naturally oriented to face away from an adjacent portion of the elongated element. Upon passing and / or moving another portion of the elongated element through the passageway, the stopper is rotated and / or aligned such that the protruding direction(s) faces away from and / or minimally interferes with the other (e.g., adjacent) portion of the elongated element.In some embodiments, one stopper at one of the elongated element is fixed to the passageway walls. The fixed stopper is oriented such that the shorter dimension is in contact and / or in line with an adjacent portion of the elongated element while the longer dimension is oriented not to contact and / or interfere with this portion. This fixing potentially prevents the geometry from rotating and aligning in a direction that interferes with the portion of the elongated element that passes and / or moves through the passageway. For example, in cases where there is relatively high friction between the elongated element and the stopper, such as if the elongated element comprises sharp protrusions that could catch and / or pull on the stopper, or if the stopper contains sharp edges that could catch on the elongated element.

[0133] In some embodiments, the surface and / or edges of the stopper are rounded and / or smooth for potentially reducing the friction between the stopper and a portion of the extended element moving next to it. Alternatively or additionally, the extended element surface is rounded and / or smooth to potentially reduce the friction between portions thereof while they are moving in close proximity to the stopper and / or in contact with each other. The friction reduction potentially reduces the risk of a moving portion of the extended element dragging the stopper and / or another portion of the elongated element into the passageway (thereby undesirably loosening and / or opening the constriction) or pulling it away from its current location for example, away from the passageway (thereby undesirably over-tightening the constriction).

[0134] In some embodiments, the elongated element comprises radially protruding sections, which may be oriented to face away from contacting the stopper.

[0135] In some embodiments, the stopper is not fixed to the passageway wall and can be rotated. In some embodiments, the geometry and / or the elongated element is round and / or smooth enough that an interaction therebetween allows the geometry to rotate and align in the desired orientation (e.g., the radial protruding direction facing a direction other than toward an adjacent elongated element portion).

[0136] In some embodiments, the stopper comprises a lumen for the entry and / or passage of the extended element. In some embodiments, the stopper surrounds the elongated element.

[0137] In some embodiments, the stopper partially surrounded the elongated element, optionally, sufficient to grip the elongated element and / or obstruct the end thereof from entering into the passageway while leaving a portion of the extended element bare of the stopper (e.g., a missing segment). In some embodiments, the missing segment extends across no more than 60% of the circumference of the stopper and / or exposes no more than 60% of the extended element circumference. For example, about 30%-60%, or 50%-70%, or 35%-45%, or about 50%, or about 60%, or lower or higher or intermediate ranges or percentages. These percentages is designed to potentially prevent the risk of the elongated element disengaging from the stopper through the missing segment.

[0138] The diameter reducer may be assembled such that the stopper next and / or fixed to the passageway is oriented such that the bare portion is adjacent to the portion of the elongated element, adjacent to the stopper, and / or moving through the passageway. This has the potential advantage of further reducing and / or avoiding interfering with and / or distorting the elongated element portion passing through the passageway.

[0139] 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.

[0140] Referring now to the drawings, Figure 1, shows an adjustable constrictor 200, mounted on an implantable medical device, such as a deformable tubular wall 100, in accordance with some exemplary embodiments of the invention.

[0141] Constrictor 200 is at least partially mounted circumferentially on deformable tubular wall 100, designated for deployment within a blood vessel.

[0142] In the example shown, deformable tubular wall 100 comprises an inner lumen 102 for blood flow therethrough. Constrictor 200 forms a radially narrowed section on deformable tubular wall 100 which reduces the effective diameter of inner lumen 102 and constitutes a bottleneck for blood flow therethrough. Deformable tubular wall 100 can be provided with constrictor 200. Alternatively or additionally, constrictor 200 can be assembled on deformable tubular wall 100 optionally, by a physician. In some embodiments of the invention, constrictor 200 circumferentially surrounds the outer surface of deformable tubular wall 100. Alternatively, or additionally, constrictor 200 is threaded through the wall of deformable tubular wall 100, for example, through apertures between struts (or other structures) thereof. Referring now to Figure 2, showing a front view of an adjustable constrictor 200 for reducing the effective diameter of an implantable medical device, such as a deformable tubular wall 100, in accordance with some exemplary embodiments of the invention.

[0143] Constrictor 200 comprises a filament 202 and a lock 204 defining a closed shape 208. Lock 204 has an inner lumen 205, shaped and sized to allow movement of filament 202, optionally under an axial force applied on filament 202 (e.g., to overcome friction and / or geometric interference between lock 204 and filament 202). In some embodiments of the invention, inner lumen 205 has a fixed inner diameter, alternatively or additionally, inner lumen

[0144] 205 has a non-uniform inner cross-section. In some embodiments of the invention, lock 204 surrounds inner lumen 205 from all sides. Alternatively, lock 204 may have a longitudinal opening (e.g., a slit) so inner lumen 205 is surrounded from, for example, between 270 and 358 degrees.

[0145] Closed shape 208 is formed by a portion of filament 202 inserted into inner lumen 205, and another portion coupled to lock 204, optionally, by being inserted to lock 204, alternatively, by being anchored to lock 204 at one of the edges thereof and / or by being anchored to the surface of lock 204, optionally to the outer surface, alternatively, to the inner surface of lock 204. In some embodiments of the invention, the other portion is not fixed to the lock but extends through inner lumen 205 or a separate lumen and may include a movement restricting mechanism (e.g., stopper), for example as described herein, of a same or different type. At least when constrictor 200 is not fully open (closed shape 208 is not at the maximum diameter thereof), a free length

[0146] 206 of filament 202 optionally protrudes from lock 204. Optionally and / or additionally, free length 206 of filament 202 protrudes from lock 204. In some embodiments, free length 206 is sufficiently long such, that when added to the circumference of closed shape 208, the diameter of closed shape 208 equals and / or slightly exceeds the circumference of the fully expanded deformable tubular wall. In some applications, free length 206 extends through the body of the patient in which the device is implanted, for example, through a blood stream and may be (or an extension thereof), for example, between 10 and 200 cm long. In other applications, free length 206 is heat-treated, optionally with a radius, to be adjacent to the constricted circumference, optionally by at least partially encircle constrictor 200 and / or deformable tubular wall 100.

[0147] When constrictor 200 is mounted on deformable tubular wall 100 (as shown in Fig. 1), free length 206, is optionally arranged to be wrapped around the outer surface of deformable tubular wall 100, and optionally remains in contact therewith, optionally with no loose filament 206 protruding toward the blood vessel walls and / or dangling in the blood stream. In some embodiments of the invention, the assembly of constrictor 200 is provided by filament 202 reaching lock 204 from opposite directions of lock 204 so that lock 204 is incorporated within the circumference of closed shape 208. A potential advantage of having lock 204 in line within the circumference of closed shape 208 is that it does not extend outward toward the blood vessel walls upon deployment of deformable tubular wall 100.

[0148] In some embodiments of the invention, the assembly of constrictor 200 is by filament 202 reaching lock 204 from the same direction of lock 204, so that lock 204 is exterior to the circumference of closed shape 208. Lock 204 external to the circumference of closed shape 208 has the potential advantage of achieving a more uniformly tightening around deformable tubular wall 100.

[0149] In some embodiments of the invention, a stopper 210 is attached to at least one end of filament 202. The diameter of stopper 210 is optionally larger than the diameter of inner lumen 205, which potentially prevents at least one end of filament 202 from entering lock 204 (when fully opening closed shape 208). In some embodiments, the diameter of inner lumen 205 is about 0.42 mm. For example, 0.4-0.5 mm, or 0.42-0.55 mm, or 0.35-0.45 mm, or 0.3-0.6 mm or about 0.45 mm, or lower or higher or intermediate ranges or diameters. In some embodiments, the diameter of stopper 210 is about 0.3-0.5 mm. For example, 0.32-0.45 mm, or 0.4-0.5 mm, or 0.5- 0.7 mm, or about 0.4 mm, or lower or higher or intermediate ranges or diameters.

[0150] In some embodiments, the outer diameter lock 204 is about 0.64 mm. For example, 0.64-1 mm, or 0.4-0.65 mm, or 0.5- 1.5 mm, or 0.5- 1.2 mm or about 0.7 mm, or lower or higher or intermediate ranges or diameters.

[0151] In some embodiments of the invention, a second stopper 211 is attached to the other end of filament 202 and is located adjacent to lock 204, optionally to an opening of lock 204. In some embodiments, stopper 211 is located at another opening of lock 204 than stopper 210. Stopper 211 is obstructed from entering into lock 204 such that it maintains closed shape 208 from opening.

[0152] In some embodiments, stopper 210 and / or 211 potentially prevent constrictor 900 from being erroneously opened and departing from deformable tubular wall 100, having the potential advantage of reducing the risk of constrictor 200 drifting in the blood vessel, for example reducing the risk of constrictor 200 embolizing downstream to the lungs, when the implanted medical device (e.g., tubular wall 100, double layer implantable device 300) is placed in the pulmonary artery. In some embodiments, both ends of filament 202 are threaded through lock 204 such that the effective inner lumen thereof is reduced so that the diameter of stopper 210 (and / or stopper 211) can be smaller than the diameter of inner lumen 205.

[0153] In some embodiments of the invention, passage of filament 202 through lock 204 is obstructed by geometric interference therebetween. The shape and / or size of filament 202 and / or lock 204, and / or certain parts thereon, restricts their relative movement with respect to each other. Some exemplary embodiments of the geometric interference are further illustrated in Figures 4, 5, and 6. The geometric interference to movement of filament 202 passing through lock 204 can be used to define a required activation force to overcome thereof.

[0154] In the absence of sufficient axial force applied on filament 202, lock 204 prevents filament 202 from passing through inner lumen 205, and the dimensions of closed shape 208 are maintained. For passing filament 202 through lock 204, a sufficient axial force is required to overcome an activation force for movement therebetween. When a sufficient force is axially applied on filament 202, filament 202 moves through lock 204, altering the dimensions of closed shape 208. Filament 202 can move in two axial directions through lock 204. Pulling free length 206, with sufficient force, reduces the diameter of closed shape 208. Applying sufficient force in the opposite direction enlarges the diameter of closed shape 208. Such force can be provided, for example, by inflating a balloon in inner lumen 102 of the implantable medical device and / or by pushing free length 106.

[0155] In some embodiments of the invention, the activation force required to reduce the diameter of closed shape 208 is less than the force required to open constrictor 200 by enlarging the diameter of closed shape 208. Alternatively, the activation force required for enlarging the diameter of closed shape 208 is sufficiently less than the force required to tighten constrictor 200. In some embodiments, the forces may be equal. It is noted that the force need not be uniform for all steps. For example, the force required for constricting may be increased as inner lumen 102 is more constricted.

[0156] The geometric interference to passage of filament 202 through lock 204 can result in relatively high resistance to movement (and more reliable resistance) compared to friction-based interactions, so lock 204 can be of a relatively short axial length. A potential advantage of lock 204 with a short axial length is reducing interference with the uniformity of force (and / or shape) applied by constrictor 200 on deformable tubular wall 100, when lock 204 is in-line with closed shape 208. Another potential advantage is reducing the risk of damaging the vessel walls, when lock 204 extends away from closed shape 208. In some embodiments, lock 204 is about 1-4 mm, for example, 1.5-2 mm long, or 1-4 mm long, or about 2 mm long, or about 3 mm, or lower or higher or intermediate ranges of lengths.

[0157] Referring now to Figure 3, showing an adjustable constrictor 200 mounted on deformable tubular wall 100 deployed within a blood vessel, in accordance with some exemplary embodiments of the invention.

[0158] Constrictor 200 mounted on deformable tubular wall 100 forms a circumferentially extending narrowing and / or a potential circumferential narrowing thereon.

[0159] When constrictor 200 is not fully open, free length 206 protrudes from lock 204, optionally, wrapped around deformable tubular wall 100. The force that the wrapped free length 206 exerts inwards on deformable tubular wall 100, is optionally not enough to collapse the diameter thereof. In some embodiments, free length is wrapped around deformable tubular wall 100 to prevent thereof from dangling in the bloodstream and / or penetrating the vessel wall.

[0160] A circumferential narrowing is formed when constrictor 200 is tightened around deformable tubular wall 100 and the diameter of closed shape 208 is reduced compared to the diameter of deformable tubular wall 100. The force applied by constrictor 200 on deformable tubular wall 100, reduces the diameter thereof so that constrictor 200 forms a radial neck on the deformable tubular wall 100. The radial neck is of reduced diameter compared to the diameter at the natural state of deformable tubular wall 100.

[0161] The radial neck optionally constitutes a bottleneck for blood flow therethrough and constricts the effective diameter for flow.

[0162] The length of the radial neck relatively to the longitudinal axis of deformable tubular wall 100 is defined by filament 202. Since filament 202 is very thin, the formed radial neck can be axially short. A potential advantage of a short radial neck is the ability to constrict the effective diameter of relatively short implantable medical devices, designated for short implantation locations. For example, in some embodiments, the cross-section of filament 202 has a diameter of about 0.2 mm, for example about 0.18 mm, or 0.22 mm, or 0.20 mm, or 0.18-0.0.22 mm, or 0.15- 0.25 mm, or 0.1-0.5 mm or lower or higher or intermediate ranges or diameters.

[0163] The level of constriction can be adjusted by moving filament 202 through lock 204, back and / or forth, axially to lock 204 and circumferentially to open / close shape 208.

[0164] The adjustment can be done prior, during and / or after the deployment (for example by pulling on the end of filament 202, for example by the end extending out of tubular wall 100 and / or out of the body) of deformable tubular wall 100 within a blood vessel. Potentially, there is no limit to the number of times adjustments can be made, prior, during and / or after implantation and for as long that deformable tubular wall 100 is deployed within a blood vessel.

[0165] The degree of constriction can optionally be increased by tightening constriction mechanism 200 around deformable tubular wall 100. Tightening is, for example, by pulling free length 206 of filament 202, axially relative to the longitudinal axis of lock 204. The diameter of closed shape 208 is further reduced and results in a narrower radial neck on deformable tubular wall 100. The force applied by axially pulling free length 206 is sufficient to overcome the geometric interference to passage of filament 202 through lock 204.

[0166] The level of constriction can be reduced by inserting a balloon into inner lumen 102 of deformable tubular wall 100, to generate sufficient force to overcome the geometric interference to passage of filament 202 through lock 204. For example, a non-compliant balloon having a nominal pressure of 6 atm, with a burst pressure 18 atm (such as Atlas Gold balloon 16mm x 40mm length 120cm (ATG120164)). The diameter of closed shape 208 is increased and results in a wider radial neck on the deformable tubular wall. Alternatively or additionally to using a balloon, the diameter of closed shape 208 can be increased by advancing free length 206 into lock 204.

[0167] Constrictor 200 mounted on deformable tubular wall 100, deployed within a blood vessel, can experience a variety of chronic outwards forces, arising, inter alia, from the blood flowing through inner lumen 102 and from the radial force exerted by tubular wall 100.

[0168] Filament 202 and lock 204 are designed to have geometric interference to movement therebetween that can withstand these forces and generally act as a step function - no movement (or lasting change) until a certain force threshold is exceeded. This may prevent slow creeping of the geometry of the implant. The activation force to overcome the geometric interference to movement of filament 202 passes through lock 204 is greater than the forces that constrictor 200 experiences at the implantation site. Lock 204 interferes with the passage of filament 202 therethrough and maintains the pre-set constriction level on deformable tubular wall 100.

[0169] In some embodiments of the invention, deformable tubular wall 100 is designated for deployment in an implantation site characterized by relatively high chronic (e.g., continuous and / or pulsatile and / or occasional) outwards forces. The geometric interference to passage of filament 202 through lock 204 is enhanced so that constriction mechanism 200 can withstand the enhanced outwards forces.

[0170] In some embodiments of the invention, deformable tubular wall 100 is an inner layer of a double-layer implantable device 300, placed within an outer layer 101. In some embodiments, the outer layer 101 is configured for contacting the blood vessel walls wherein deformable tubular wall 100 is configured to have an adjustable effective diameter for flow and / or pressure by mounting constrictor 200 thereon.

[0171] In some embodiments, a constrictor 200 mounted on inner deformable tubular wall 100 is radially detached from the blood vessel walls, having the potential advantage of minimizing contact between constrictor 200 and the blood vessel walls and / or potentially minimizing irritation and / or pinching the blood vessel walls, when the constrictor is static and / or during adjustment of the constrictor.

[0172] In some embodiments of the invention, a double-layer implantable device can be relatively short, since it is designated for short implantation locations, such as the pulmonary artery. In some embodiments, outer layer 101 anchors the implantable medical device to the blood vessel and reduces the need for axial anchoring sections which typically extend the length of the device. In some embodiments, constrictor 200 which comprises thin filament 202 which can form an axially short radial neck can be suitable to be mounted on a relatively short inner deformable tubular wall 100 and constrict the effective diameter thereof. Constrictor 200 allows adjusting the level of constriction of inner deformable tubular wall 100, optionally, gradually, optionally, in steps.

[0173] Referring now to Figure 4 showing a schematic illustration of constrictor 400 comprises a filament 402 with radially protruding sections 403, in accordance with some exemplary embodiments of the invention.

[0174] In some embodiments of the invention, filament 402 comprises plurality of radially protruding sections 403. Generally, the size and / or shape of radially protruding sections 403, together with the size and / or shape of inner lumen 405 of lock 404 defines the geometric interference to passages of filament 402 through lock 404. Deformability and elasticity (and friction) optionally define the reaction of the geometric interference to applied forces.

[0175] The force required for passing radially protruding sections 403 through lock 404 is significantly larger than the force required for passing filament 402 (bare of the radially protruding sections). In some embodiments of the invention filament 402 (bare of the radially protruding sections), can move freely through lock 404, alternatively or additionally, some force is required for passing thereof through lock 404.

[0176] The intervals between radially protruding sections 403 generally define the step distance of the stepped passage of filament 402 through lock 404. Such intervals may be equal in length or may be non-uniform. In some embodiments of the invention the intervals between radially protruding sections 403 are equal and / or approximately equal, defining uniform step distance.

[0177] In some embodiments, radially protruding sections 403 are spread along the length of filament 402.

[0178] In other embodiments, radially protruding sections 403 are spread along at least one end portion of filament 402, having the potential advantage of allowing the middle portion of filament 402 to be free of radially protruding sections 403 which may potentially form a shorter radial neck on deformable tubular wall 100. In addition, the location of the most distal radially protruding section 403 from the end of filament 402 defines the most constricted diameter of closed shape 408. This potentially allows limiting the maximum constriction level by setting a desired minimum diameter of closed shape 408.

[0179] In some embodiments of the invention, since the step distance is known, the number of steps can be calculated according to a desired constricted diameter. In some embodiments, the steps are at a distance of 0.5 mm in diameter, meaning that each step changes the diameter of closed shape 408 in 0.5 mm and the length of filament 402 in 0.5*pi mm length. In some embodiments, the diameter of closed shape 408 can be adjusted to be between 7mm to 10 mm, optionally, in 0.5 mm steps of diameter, alternatively or additionally, closed shape 408 can be adjusted to be between 7mm to 16 mm, where of 16 mm is the fully opened diameter of closed shape 408.

[0180] In some embodiments of the invention, the intervals between the radially protruding sections are relatively large, having the potential advantage of allowing relatively quick progress of filament 402 through the lock 404, which results in quicker adjustment of the constriction.

[0181] In some embodiments of the invention, the intervals between the radially protruding sections 403 are relatively small, having the potential advantage of enhancing the accuracy and / or sensitivity when setting and / or adjusting the constriction.

[0182] In some embodiments of the invention, the intervals between the radially protruding sections are not equal.

[0183] In some embodiments of the invention, the distance between protrusions is smaller than a length of the hollow lock. This means that at least one protrusion must be in the passageway of the hollow lock at any time. This may be useful to increase resistance to movement.

[0184] In some embodiments of the invention constrictor 400 has a single free length 406, and the intervals between the radially protruding sections are larger in proximity to the ends of free length 406, and smaller, optionally, gradually, along filament 402. This has the potential advantage of increasing sensitivity when reaching small diameters, in addition to accelerating the adjustment when the constrictor is opened. This may be important due to non-linear effect of diameter on flow in blood vessels.

[0185] In some embodiments of the invention, constrictor 400 has a free length 406 and a free length 407, and the intervals between the radially protruding sections are larger at proximity to the ends of filament 402, and smaller toward the center thereof.

[0186] In some embodiments of the invention, the radially protruding sections 403 along filament 402 are identical and / or approximately identical. The identical radially protruding sections 403 define a uniform required force to overcome the geometric interference of each section.

[0187] Alternatively, or additionally, filament 402 comprises various radially protruding sections 403, which can differ in size and / or shape and / or combination thereof. Each various of radially protruding sections 403 define different required force to overcome thereof.

[0188] In some embodiments of the invention radially protruding sections 403 are aligned along filament 402, alternatively or additionally, radially protruding sections 403 are radially spread along filament 402. For example, one may extend more in one radial direction and another may extend more in another radial direction. This may encourage bending the filament 402 when in the passageway.

[0189] Alternatively or additionally to radially protruding sections 403 spread along filament 402, radially protruding sections 403 can be spread along an end portion of filament 402. In some embodiments, the length of the end portion of filament 502 which contains radially protruding sections 403 defines a maximum constriction level, having the potential advantage of avoiding over-narrowing. This end portion, which contains radially protruding sections 403 can be moved within lock 404 (upon applying sufficient force) whereas the other end of filament 402 is optionally fixed to lock 402. In some embodiments, constrictor 400 comprises at least one stopper 410 at the end of filament 402. Stopper 410 potentially prevents the extremity of filament 402 from entering lock 404, which could result in the unraveling closed shape 408.

[0190] In some embodiments, constrictor 400 comprises a second stopper 411 at the end of filament 402 that is optionally fixed to lock 404. Stopper 411 prevents the other extremity of filament 402 from entering lock 404.

[0191] In some embodiments of the invention, radially protruding sections 403 are larger than inner lumen 405 (and / or than an effective diameter of inner lumen 405). In the absence of sufficient applied force radially protruding sections 403 are prevented from entering into lock 404 (or some other narrowed section thereof). In some embodiments, both ends of filament 202 are threaded through lock 204 such that the effective inner lumen thereof is reduced so that the diameter of radially protruding sections 403 can be smaller than the diameter of inner lumen 405. This potentially reduces the effective width of constrictor 400, which can result in a thinner narrowing on the deformable tubular wall (e.g., deformable tubular wall 100 shown in Figure 1), which can be beneficial if the deformable tubular wall is relatively short and intended for short implantation locations.

[0192] When sufficient force is applied, the radially protruding sections and / or lock 404 can deform and / or bend and / or retreat and / or any combination thereof, when filament 402 is passing through lock 404. Alternatively, or additionally, the radially protruding sections are of the same dimensions as inner lumen 405. In the absence of sufficient applied force radially protruding sections 403 are obstructed from passing through inner lumen 405, by friction with the inner surface of lock 404.

[0193] When sufficient force is applied, the radially protruding sections and / or lock 404 can deform and / or bend and / or retreat and / or any combination thereof, to reduce friction when filament 402 is passing through lock 404 and / or to overcome the force of friction.

[0194] Referring now to Figure 5, showing a fractional view of constrictor 500 comprises a bent filament 502, in accordance with some exemplary embodiments of the invention.

[0195] Constrictor 500 is a detail of an embodiment of constrictor 400.

[0196] Filament 502 defines and comprises a plurality of bent sections 503, projecting radially away from the longitudinal axis thereof. Bent sections 503 obstruct the passage of filament 502 through lock 504, and define geometric interference to passage of filament 502 through lock 504.

[0197] The level of geometric interference is optionally determined by the size and / or shape of bent sections 503, the diameter of inner lumen 505 and longitudinal length of lock 504. Lock 504 is sufficiently long so that movement thereof along the curvature of bent sections 503 is obstructed as well.

[0198] In some embodiments of the invention, the height (h) of bent sections 503 is larger than the diameter of inner lumen 505. Bent sections 503 protrude radially more than lock 504. In the absence of an applied force, bent sections 503 obstruct the movement of filament 502 through lock 404.

[0199] In some embodiments of the invention, the height (h) of bent sections 503 matches the diameter of inner lumen 505. Bent sections 503 protrude radially up to lock 504. In the absence of an applied axial force, the friction between inner lumen 505 and bent sections 503 maintains filament 502 from moving within lock 504. At least one of bent sections 503 and / or lock 504 is deformable and / or elastic. The level of elasticity and / or deformability is optionally selected so that when a sufficient force is applied on filament 502, bent sections 503 can deform (due to force applied thereon by the edge of lock 504) to enter and pass through lock 504, optionally, by straightening along the longitudinal axis of filament 502. Alternatively, or additionally, lock 504 deforms to contain bent sections 503 passing therethrough.

[0200] In some embodiments of the invention, the circumference of the opening in lock 504 is rounded or otherwise inclined, which may assist in reduced friction and / or guiding bending, during deformation of bent sections 503.

[0201] In some embodiments of the invention, the level of elasticity and / or deformability is optionally selected so that the required activation force to overcome the geometric interference to movement between bent sections 503 and lock 504 can be achieved by a physician manually pulling and / or pushing free length 106, or by a force exerts by a balloon inserted into lumen 505.

[0202] In some embodiments, a dilation pressure (applied for example by a non-compliant balloon) of about 6 atm is required to increase the diameter of constrictor 500. For example, 5-12 atm, or 3-19 atm, or 6-10 atm, or about 6 atm, or about 8 atm, or lower or higher or intermediate ranges or pressures.

[0203] The bent sections 503 are positioned at intervals along Nitinol wire 102 forming alternating sections, bent and un-bent 501.

[0204] In some embodiments of the invention, bent sections 503 obstruct the passage of filament 502 through lock 504 whereas un-bent sections 503 can pass freely therethrough. When enough force is applied, filament 502 moves through lock 504 in steps. Each bent section 503 defines a stopping point for this movement, due to the need to apply increased force to deform the bent section 503 contacting lock 504. Optionally, there is friction between un-bent sections 501 and inner lumen 505. The activation force required to overcome the friction of un-bent sections 501 passing through lock 504 is generally less than the activation force required to overcome the geometric interference to movement of bent sections 503 through lock 504.

[0205] A potential advantage of filament 502 passing through lock 504 in steps, is a controlled and measured modification of the constriction on deformable tubular wall 100. In addition, the plurality of bent sections 503 defines a plurality of locking positions.

[0206] Under applied force, filament 502 passes through lock 504, alternating the location of lock 504 along the length thereof. After the force is removed, filament 502 is once again hindered from passing through lock 504, by a bent section positioned near the new location of lock 504 along filament 502. Once the force is removed, the adjacent bent section cannot enter into inner lumen 505. The modified diameter of closed shape (for example closed shape 208 shown in Fig. 2) is maintained by the geometric interference to movement.

[0207] In some embodiments of the invention, bent sections 503 are symmetrical in an axial direction so that the force required to pass filament 502 through lock 504 in one direction is equal to the force for passing filament 502 through lock 504 in the opposite direction.

[0208] In some embodiments of the invention, bent sections 503 are asymmetrical so that the force required to tighten the constrictor 500 is less than the force required to open the constriction. Alternatively or additionally, the force required to tighten the constrictor 500 is substantially equal and / or greater than the force required to open the constriction.

[0209] For example, in some embodiments, the shape and / or size of bent sections 503 together with the shape and / or size of inner lumen 505 of lock 504 is selected to obtain force to tighten constrictor 500, for example in the pulmonary artery of an adult, of about 3.54 ± 0.95 [N], for example, 3.5 [N], or 2.59 [N], or 4.49 [N], or 2.5-4.5 [N], or 3.2-3.7 [N], or lower or higher or intermediate ranges or forces. Another example is the shape and / or size of bent sections 503 together with the shape and / or size of inner lumen 505 of lock 504 which selected to obtain force for to open constrictor 500 of about 2.98 ± 0.70 [N], for example, 2.28 [N], or 3.68 [N], or 3.0 [N], or 2.5-4.0 [N], or 2.9-3.7 [N],

[0210] The activation force to overcome the geometric interference to passage of bent filament 502 through lock 504 is typically selected to be greater than the external forces applied on constrictor 500 provided on deformable tubular wall 100 deployed within a blood vessel. The geometric interference to movement potentially maintains lock 504 at a pre-set location along filament 502 and maintains the pre-set diameter of enclosed shape 508. The un-changed dimensions of enclosed shape 508 maintain the constriction level on deformable tubular wall 100.

[0211] In some embodiments of the invention the height (h) of bent sections 503 is relatively high to achieve relatively high interference for passing filament 502 through lock 504. Constrictor 500 having relatively high geometric interference to movement of filament 502 through lock 504 has the potential advantage to be able to withstand relatively high chronic outwards forces and to be mounted on deformable tubular wall 100 designated for deployment in a bold vessel characterized in relatively high chronic outwards forces. For example, in some embodiments, the height (h) of bent sections 503 is about 1mm, and / or about 0.4-2.5 mm, for example, 0.5 mm, or 1 mm or 2 mm, or 0.8-1.2, of 0.5-2 mm, or 0.4-2.5 mm, or lower or higher or intermediate ranges or lengths. In some embodiments, the axial length of lock 504 is substantially equal to the length of un-bent section 501. In some embodiments, upon release of an applied force, lock 504 is placed overlapping with un-bent section 501. The movement of lock 504 along un-bent section 501 is obstructed by two adjacent bent sections 503, each is located on a different side of lock 504.

[0212] In some embodiments, the axial length of lock 504 is substantially smaller than the length of un-bent section 501. In some embodiments, upon release of an applied force, lock 504 is between two bent section 503, having the ability to move therebetween. In some embodiments, high chronic outwards forces apply pressure in the radial direction of deformable tubular wall 100 which moves lock 504 to be adjacent to one of the bent section 503, which obstructs further movement thereof.

[0213] In some embodiments, upon release of an applied force, a bent section 503 is located within lock 504 (e.g., having a length substantially equal and / or substantially smaller than the length of un-bent section 501), optionally in a deformed form. In some embodiments, the friction between the bent section and the inner walls of lock 504 obstructs the relative movement between lock 504 and filament 502.

[0214] In some embodiments, high chronic outwards forces apply pressure in the radial direction of deformable tubular wall 100, causing lock 504 to move, allowing the bent section 503 to disengage from lock 504. Subsequently, lock 504 is positioned between two contiguous bent sections 503, which is potentially a more stable locking position.

[0215] In some embodiments, the axial length of lock 504 is substantially larger than the length of un-bent section 501. In some embodiments, upon release of an applied force, lock 504 at least partially contains at least one bent section 503. In some embodiments, if lock 504 is sufficiently long, a continuous movement of lock 504 along filament 502 is obtained.

[0216] In some embodiments of the invention, constrictor 500 is mounted on deformable tubular wall 100 designated for deployment in a blood vessel characterized by relatively low chronic outwards forces. The height (h) of bent sections 503 is optionally relatively low to achieve relatively low geometric interference for passing filament 502 through lock 504.

[0217] In some embodiments of the invention filament 502 is bent to include triangular segments 503. In some embodiments of the invention the triangular (or other shape) segments are asymmetrical, having a moderate slope on one side and a steep slope on the other. The asymmetrical triangular segments set different forces for tightening and / or releasing constrictor 500.

[0218] In some embodiments of the invention, the force requires to tighten constrictor 500 is sufficiently less than the force required to open the constriction. For example, the moderate slope of triangular segments 503 faces lock 504 when filament 502 is passed through inner lumen 505 to tighten the constriction. The steep slope of triangular segments 503 faces lock 504 when Nitinol wire 502 is passed through lock 504 to open the constriction.

[0219] The steeper side is optionally selected to resist what is expected to be the greater environmental force and / or to prevent the less desired outcome - in some cases opening and in some cases closing of the constriction.

[0220] In some embodiments of the invention triangular segments 503 are symmetrical. The symmetrical triangular segments can define an equal activation force form tightening or releasing the constriction.

[0221] The activation force to overcome the geometric interference to movement between lock 504 and triangular bent sections 503 of filament 502 is optionally defined by the slope and / or the height of triangular bent sections 503.

[0222] In some embodiments of the invention, the activation force to overcome the geometric interference to movement between lock 504 and triangular bent sections 503 of filament 502 is greater than the external forces applied on constrictor 500 mounted on deployed deformable tubular wall 101. In some embodiments of the invention, the height (h) and / or slope of triangular bent sections 503 is relatively high and / or steep to achieve relatively high interference to movement for constrictor 500 designated for deployment in a bold vessel characterized in relatively high chronic outwards forces. In some embodiments, the base angles of triangular bent sections 503 (that undergo straightening) can be between about 20-90 degrees. For example, 25 degrees, 40 degrees, 85 degrees, 30-60 degrees, or 20-90 degrees, or lower or higher or intermediate ranges of degrees. In some embodiments, triangular bent sections 503 are asymmetrical, having different base angles, each within the range of 20-90 degrees. Alternatively or additionally, triangular bent sections 503 are symmetrical, shaped as an isosceles triangle having different base angles, each within the range of 20-90 degrees.

[0223] In some embodiments of the invention filament 502 is a Nitinol wire, optionally pretreated to form bent sections, optionally, pre-treated with heat.

[0224] In some embodiment, the diameter of the cross-section of the Nitinol wire is small enough so that a pre-treatment such as heat treatment results in radially protruding sections, such as bent sections 503. On the other hand, the diameter of the cross-section of the Nitinol wire is sufficiently large to obtain a required mechanical strength, to avoid breakage during treatment. In addition, the treated Nitinol wire should have sufficient mechanical strength to hold the constrictor whole, upon mounting thereof on deformable tubular wall 100, adjusting the constriction level and / or under chronic outwards forces exerted on a deployed constrictor. It is noted that a small cross-section’s diameter is significant for obtaining constrictor with tortuosity ability and / or for the ability to form a narrow radial neck on deformable tubular wall 100, having the potential advantage to fit onto a relatively short implantable medical device, designated for short blood vessels. In some embodiments, the diameter of the cross-section of the Nitinol wire is as small as possible, while retaining the mechanical strength thereof. In some embodiments, the diameter of the cross-section of the Nitinol wire is about 0.2 mm , for example, 0.19 mm, or 0.22 mm, or 0.24 mm, or 0.22 mm, or 0.18-0.0.22 mm, or 0.15-0.25 mm, or 0.1-0.5 mm or lower or higher or intermediate ranges or diameters. In some embodiments, the pre-treatment of Nitinol wire comprises electropolish, which may reduce its diameter by about 0.001.

[0225] In some embodiments of the invention lock 504 has a cylindrical shape, optionally formed from Nitinol. Alternatively or additionally to Nitinol, lock 504 is formed from a polymer and / or other metal(s).

[0226] In some embodiments, the outer diameter of lock 504 is about 0.5-0.6 mm, for example, 0.5 mm, or 0.55 mm, or 0.65 mm, or 0.5-0.6 mm, or 0.2-0.8 mm, or 0.2-1 mm or lower or higher or intermediate ranges or diameters. In some embodiments, the inner diameter of lock 504 is about 0.4-0.5 mm, for example, 0.35 mm, or 0.41 mm, or 0.5 mm, or 0.35-0.5 mm, or lower or higher or intermediate ranges or diameters. In some embodiments, lock 504 is about 2 mm long mm, for example, 1.8 mm, or 1.9 mm, or 2.5 mm, or 1-03 mm, or lower or higher or intermediate ranges or diameters.

[0227] In some embodiments, a stopper 510 (not shown) is mounted on at least one end of filament 502. The diameter of stopper 510 is optionally larger than the effective diameter of inner lumen 505, which prevents at least one end of filament 502 from moving through lock 504, and potentially maintains constrictor 100 unraveled. In some embodiments, a second stopper 511 is located at the other end of filament 502, optionally adjacent to an opening of lock 504, optionally welded thereto, and potentially maintains constrictor 100 unraveled by the entrance of the opposite end of filament 502 into lock 504.

[0228] In some embodiments, the bent sections 503 are located at an end portion of filament 502 adjacent to stopper 510. This end portion can move through lock 504 (upon sufficient applied force), while the opposite end portion of filament 502 is fixed to lock 504.

[0229] Referring now to Figure 6, showing a fractional view of a constrictor 600 comprises filament 602 having radially protruding thickened sections 603, in accordance with some exemplary embodiments of the invention.

[0230] Constrictor 600 is a detail of an embodiment of constrictor 400. Filament 602 comprises thickened sections 603, optionally, symmetrical, around the radial axis of filament 602, protruding away from the longitudinal axis thereof.

[0231] In some embodiments of the invention the radially protruding thickened sections 603 are radially protruding spheres 603.

[0232] Radially protruding spheres 603 define geometric interference to passage of filament 602 through lock 604. In some embodiments of the invention the cross-section surface of the wire including the radially protruding spheres 603 is larger than inner lumen 605.

[0233] The radially prominent spheres 603 positioned in intervals along filament 602.

[0234] In the absence of sufficient applied force radially protruding spheres 603 are obstructed from entering into lock 604. When sufficient force is applied, the radially protruding spheres 603 defines stepped passage of the filament 602 through lock 604. The radially protruding spheres 603 act as stopping points for filament 602 as it passes through lock 604. When the force is removed, radially protruding spheres 603 act as locking points, obstructing the passage of filament 602 through lock 604.

[0235] In some embodiments of the invention the diameter of filament 602 (bare of radially protruding spheres 603) is smaller than the diameter of inner lumen 605, so filament 602 can move freely therethrough, alternatively or additionally, the force required for passing Nitinol wire 602 (bare of radially protruding spheres 603) through lock 604 is significantly smaller than the force required for passing filament 602 including radially protruding spheres 603 therethrough.

[0236] In some embodiments of the invention, the cross-section surface of the wire including radially protruding spheres 603 matches the diameter of inner lumen 605.

[0237] In the absence of sufficient applied force, the friction between the inner lumen 605 and radially protruding spheres 603 maintains filament 602 from moving within lock 604.

[0238] In some embodiments of the invention, at least one of spheres 603 and / or filament 602 and / or lock 604 is elastic and / or deformable. The level of elasticity and / or deformability is optionally selected so that when a sufficient force is applied on filament 602, radially prominent spheres 603 and / or Nitinol wire 103 can deform to enter and passe through lock 604. Alternatively, or additionally, lock 604 deforms to contain sections of Nitinol wire including radially protruding spheres 603 passing therethrough.

[0239] In addition, the level of elasticity and / or deformability is optionally selected so that the required activation force to overcome the geometric interference to movement between sections including radially protruding spheres 603 and lock 604 can be achieved by a physician manually pulling and / or pushing free length 606, and / or by a force exerted by a balloon inserted into lumen 605. In some embodiments, filament 602 comprises Nitinol wire. In some embodiments, the Nitinol wire is pre-treated to obtain radially protruding spheres 603. For example, in some embodiments, radially protruding spheres 603 are created by exposing the Nitinol wire to laser energy at sections intended to include thereof. Alternatively or additionally, the radially protruding spheres 603 are created by a welding process. In some embodiments, these methods for generating radially protruding spheres 603 are applied to generate stoppers (for example stoppers 210, 211) at the end(s) of the filament.

[0240] In some embodiments of the invention lock 604 is formed from Nitinol, alternatively or additionally to Nitinol, lock 604 is formed from elastic polymer or other metal, such as spring steel.

[0241] In some embodiments of the invention, the diameter of radially protruding spheres 603 is about 0.1-0.2 mm, for example, 0.15 mm, 0.2 mm, 0.25 mm, or 0.1-0.25 mm or lower or higher or intermediate ranges or diameters.

[0242] In some embodiments, constrictor 600 comprises at least one stopper as previously described for constrictors 200, 400 and / or 500. In some embodiments, the diameter of the at least one stopper is larger than radially protruding spheres 603.

[0243] In some embodiments of the invention filament 602 and / or spheres 603 are formed from elastic and / or deformable material whereas lock 604 is formed from un-deformable material for example, highly deformable metals such as variations of CO-CR

[0244] Referring to Figure 7A, showing a fractional view of a cross-section of constrictor 700 comprises a lock 704 having a radial narrowing, and to Figure 7B showing a fragmentary, perspective view of a constriction mechanism comprising a lock having a radial narrowing, in accordance with some exemplary embodiments of the invention.

[0245] Constrictor 700 comprises a filament 702, such as, but not limited to, a Nitinol wire, and lock 704 having at least one radially narrowed section 701.

[0246] In some embodiments of the invention the diameter of filament 702 is larger than the opening of narrowed section 701 so when no force is applied and / or insufficient force is applied, narrowed section 701 interferes with filament 702 passing through lock 704. Narrowed section 701 defines geometric interference to passage of filament 702 through lock 704. The level of geometric interference is determined, for example, by the size of the opening of narrowed section 701 and / or by the effective diameter of filament 702. When a sufficient axially force to overcome the geometric interference is applied on filament 702, filament 702 passes through lock 704. In some embodiments, a stopper 710 is mounted on at least one end of filament 702. The diameter of stopper 710 is optionally larger than the diameter of narrowed section 701, which prevents at least one end of filament 202 from moving through lock 704, and potentially maintains constrictor 100 unraveled.

[0247] In some embodiments, at least one of filament 702 and / or narrowed section 701 is elastic and / or deformable.

[0248] In some embodiments of the invention, the level of elasticity and / or deformability is such that when a sufficient force is applied, filament 702 can deform to entre and / or passe through radially narrowed section 701 of lock 704. Alternatively, or additionally, radially narrowed section 701 deforms such that the opening is increased enough for passage of the filament therethrough.

[0249] In addition, the level of elasticity and / or deformability is optionally such that the required activation force to overcome the geometric interference to movement of filament 702 passes through lock 704 having radially narrowed section 701 can be achieved by a physician manually pulling and / or pushing free length 706, and / or by the force exerted by a balloon inserted to lumen 705.

[0250] In some embodiments of the invention, constrictor 700 comprises a lock 704 having a radial narrowed section 701 and a filament 702, optionally uniform along the longitudinal axis for example, bare of radially protruding sections. When axial force is applied on uniform filament 702 the movement within lock 704 is continuous (e.g., limited by friction and / or geometric interference caused by deformation of the filament by the lock). Once the force to adjust the constriction is removed, radial narrowed section 701 regains a grip on filament 702. Lock 704 maintains filament 702 from passing therethrough and maintains the modified dimensions of closed shape 708. The activation force for passing uniform filament 702 through radially narrowed section 701 is uniform and determined by the dimensions of the opening defined by the radially narrowed section 701 and by the diameter of the filament 702.

[0251] A potential advantage of the continuous motion is that there is an unlimited number of locking positions of constrictor 700, so that the diameter of the closed shaped can be fine-tuned.

[0252] In some embodiments of the invention radial narrowed section 701 is symmetric relative to the radial axis of filament 702. The force required for passing filament 702 through lock 704 in one direction may be the same as the force required for passage at the opposite direction.

[0253] Alternatively, or additionally, radial narrowed section 701 is asymmetric relative to the radial axis of filament 702. The force required for passing filament 702 through lock 704 in one direction may be different than the force required for passage at the opposite direction. In some embodiments of the invention radial narrowed section 701 comprises axially separated narrowed sections. In some embodiments of the invention, narrowed sections are not the same. For example, a first narrowed section may be narrowed on one side and an axially spaced apart narrowed section is narrowed at another side. This may encourage bending of an inserted filament, thereby increasing friction thereof in the passageway.

[0254] In some embodiments of the invention radial narrowed section 701 is formed by one or more intrusions of a wall of lock 704 into said inner lumen. Optionally, the wall of lock 704 is crimped to achieve at least one radial narrowed section 701. In other embodiments, lock 704 has the shape of an hourglass (for example, a venturi-like tube) where radial narrowed section 701 is of the smallest diameter.

[0255] In some embodiments, lock 704 is formed mainly of radial narrowed section 701. For example, lock 704 is a ring with a diameter small enough to obstruct movement of filament 704 therewithin.

[0256] Alternatively, or additionally to lock 704 comprises at least one radially narrowed section 701, lock 704 comprises at least one aperture along its length. Such aperture, if sized to accommodate a part of a radially protruding sphere, can act as a “stopping point” for filament movement, generating change in resistance as a sphere geometrically interfaces with such aperture.

[0257] In some embodiments of the invention lock 704 is formed from materials as described for lock 504.

[0258] In some embodiments of the invention filament 702 is formed from materials as described for filament 502.

[0259] Referring to Figure 8, showing a fractional view of a constrictor 800 comprises a lock 804 having radial narrowing 801 and filament 802 comprises altering sections of relatively high and low geometric interference to passage through lock 804, in accordance with some exemplary embodiments of the invention. Filament 802 is for example, a filament with bent and un-bent sections, and / or a filament with radially projecting protrusions such as but not limited to spheres, and / or bulges and / or bumps, and / or a filament with alternating sections of high and low roughness, and / or a filament with alternating sections of large and small diameter and / or a filament containing dents and / or holes, and / or slits.

[0260] In some embodiments of the invention filament 802 is a wire comprising radially protruding sections, as shown in Fig. 8. When sufficient axial force is applied on filament 802 the movement within radial narrowed section 801 occurs in steps, with each radially protruding section serving as a stopping point. A potential advantage of the combination of lock 804 having a radial narrowed section and filament 802 including alternating sections of high and low interference to movement when passing through the opening of radial narrowed section 801, is that progression in steps can be achieved with relatively small protruding sections 803 on filament 802. In addition, by this combination, a relatively high required activation force for altering the dimensions of closed shape 808, can be achieved. A potential advantage of the enhanced required activation force is that constrictor 800 can preserve a desired level of constriction in implantation site of high external forces, by maintaining the pre-set diameter of closed shape 808. In some embodiments of the invention, the radially protruding section are rotationally symmetric around the axis of filament 802, for example, being spherical or spheroid (e.g., ellipsoid). In some embodiments of the invention, the radially protruding sections are created by pinching of filament 802, so it is wider (and possibly thinner) at pinched areas. In other embodiments, the protruding sections are attached onto the wire. Alternatively, the wire may be formed with varying thickness sections, for example, by molding or by laser cutting.

[0261] Referring now to Figures 9A-C, showing perspective views of a constrictor 900 comprises a filament 902 with a sliding knot 904, mounted on an implantable medical device, in accordance with some exemplary embodiments of the invention.

[0262] Referring also to Figure 9D, showing an example of sliding knot 904 and an exemplary method for tying thereof, in accordance with some exemplary embodiments of the invention.

[0263] Constrictor 900 comprises filament 902 which is tied to form sliding knot 904. Filament 902 is shaped to comprise a closed shape 908, which is maintained by sliding knot 904. A Sliding knot 904 refers to any entanglement of filament 902 that can maintain closed shape 908 and allows for the adjustment of the diameter of closed shape 908, optionally, by allowing the slipping of filament 902 therethrough. For non-limiting examples, sliding knot 904 can be any of the knots known as plait knot, half hitch knot, half knot, square knot, slip knot, sliding knot, and / or grip hitch.

[0264] For example, in some embodiments, sliding knot 904 is a double tie (a knot above a knot), optionally formed by tying filament 904 twice (as shown for example in Fig. 9D). In another example, in some embodiments, sliding knot 904 is formed by filament 902 creating at least one loop, optionally, a first loop and a second loop.

[0265] Constrictor 900 has the potential advantage of being adjustable without requiring hard and / or degradable elements. Constrictor 900 has the potential advantage of being adjustable without requiring elements protruding toward the blood vessel and / or which may affect the shape (and / or uniformity) of closed shape 908.

[0266] At least one free length 906, optionally two free length 906, 907 of filament 902 protrudes from sliding knot 904. As adjusting constrictor 900, the lengths of at least one free length 906, 907 change (shortens when opening the constriction and lengthens when increasing the constriction). When constrictor 900 is fully open (closed shape 908 is at the maximum diameter thereof), the total length of at least one free length 906, 907 is at a minimum length thereof.

[0267] Constrictor 900 is at least partially mounted circumferentially on implantable medical device 300, optionally, on an inner layer in the form of deformable tubular wall 100. In some embodiments of the invention constrictor 900 is circumferentially surrounding deformable tubular wall 100. Alternatively or additionally, constrictor 900 is at least partially threaded through openings in deformable tubular wall 910.

[0268] In some embodiments of the invention filament 902 is mounted on deformable tubular wall 910, knotted with a sliding knot and then expanded (or constricted) to the desired diameter which defines the constriction level.

[0269] In some embodiments, constrictor 900 can be tied on deformable tubular wall 100 by a physician. Alternatively or additionally, deformable tubular wall 100 can be provided with constrictor 900 mounted thereon.

[0270] In some embodiments of the invention free length 906 and 907 surround the deformable tubular wall and optionally are attached together (e.g., by a knot) at a diametrically opposite side as sliding knot 904.

[0271] In some embodiments of the inventions a stopper 912 in the form of, for example, a permanent knot is tied (or otherwise provided) at least at one end of filament 902. In some embodiments, each of free length 906 and 907 have permanent knots tied to their ends. In some embodiments, the loose wire is tucked under constrictor 900.

[0272] In the absence of sufficient force applied on filament 902, sliding knot 904 limits the movement of filament 902, thereby maintaining the dimensions of closed shape 908. In some embodiments, the forces applied on constrictor 900 are as previously described.

[0273] The diameter of closed shape 908 is adjusted by pulling at least one of free length 906 and / or 907. In some embodiments, filament 902 slips over itself while sliding knot 904 stays tied. Alternatively, or additionally, filament 902 is sufficiently rigid for pushing it into lock 904, if a reduction in the level of constriction is needed during the assembly of constrictor 900.

[0274] To increase the degree of the constriction, at least one of free length 906, 907 is pulled, reducing the diameter of closed shape 908. The diameter of closed shape 908 is reduced, while filament 902 optionally slips over itself while the structure od sliding knot 904 is maintained. The constrictor tightens around deformable tubular wall 100, and further constrict the effective diameter thereof.

[0275] To reduce the degree of constriction, a balloon can be inserted to the lumen of deformable tubular wall 910. Upon inflating the balloon, sliding knot 904 moves to open the constriction diameter, while the sliding knot always remains in tension. The diameter of closed shape 908 is opened according to the diameter of the inflated balloon, enlarging the constricted diameter of the implantable device.

[0276] In some embodiments of the invention, the force required for opening the constriction can be adjusted by adding one or more ties to sliding knot 904.

[0277] In some embodiments of the invention constrictor 700 is formed from an ePTFE thread, optionally, monofilament thread, alternatively or additionally, from a braided thread, such as, but not limited to a suture thread. A potential advantage of ePTFE thread is reduced friction when passing through the loop of sliding knot 904, which may assist in opening thereof using a balloon catheter. In some embodiments, a dilation pressure of about 2-4 atm is required for increasing the diameter of constrictor 900. For example, 1.5 atm, or 2.5 atm, or 4.5 atm, or 1-5 atm, or 3-6 atm, or lower or higher or intermediate ranges or pressures. It is noted that other embodiments of constrictor 900 and / or other constrictors (e.g., constrictors 200-800) may require different pressure ranges.

[0278] Exemplary method for forming sliding knot 904 a. Wrapping filament 902 (for example ePTFE suture wire) around deformable tubular wall 100 (which is optionally an inner layer of a double-layer implantable device 300), optionally using tweezers. b. Selecting a gauge pin according to a desired constriction. For example, for constricting to a diameter of 8.5, a gauge pin of 8.4 is selected. In another example, for constricting to a diameter of 10, a gauge pin of 9.9 is selected. In some embodiments, a set of guide pins is provided, optionally for a constricted diameter between about 7-10 mm. Alternatively or additionally, the set of guide pins can include guide pins sized for other ranges of constriction. c. Inserting the gauge pin into deformable tubular wall 100. d. Tying sliding knot 904 using filament 902 (for example, ePTFE suture wire) that was wrapped around deformable tubular wall 100, according to the following steps (shown for example in Fig. 9D): 1. Placing filament 902 such that both of its edges (left 914 and right 916) can be easily distinguished.

[0279] 2. Placing the right side 916 of filament 902 on top of the left side 914 of the suture wire.

[0280] 3. Taking the right edge 916 of filament 902 and thread it underneath the left side 914 of the filament 902 into the opened loop between them.

[0281] 4. Placing the right side 916 of filament 902 on top of the left side 914 of filament 902 and making sure that the right side 916 is on top of the left side 916.

[0282] 5. Taking the right edge of the suture wire and thread it underneath the left side 914 of filament 902 into the upper loop between them.

[0283] 6. Pulling both sides of filament 902 edges to close, optionally, by using two sets of forceps, to to close the knot. e. Removing the gauge pin; f. Waiting at least 10 seconds before measuring the diameter in the next step; g. Measuring the constricted diameter using a gauge pin; h. Re-inserting the gauge pin; i. Strengthening the knot, optionally by tying another knot over the previous knot that was tied; j. Taking the two remaining edges of filament 902 and tying another knot on the opposite side of the device; k. Optionally, pulling two remaining edges of filament 902 out throughout the outer layer of double-layer implantable device 300, optionally using tweezers; l. Optionally, confirming that an annular distance of at least 45 degrees is separating between both edges that were pulled out m. Tying a simple knot at each end of filament 902, optionally cutting portion(s) of filament 902 which passes these knots. n. Tucking the two remaining edges of filament 902 under the tied filament 902, so that they doesn't flap in the blood-flow, but are still available for opening sliding knot 904.

[0284] Referring now to Figure 10, showing a flow chart describing the method for constricting and / or adjusting the effective diameter of an implantable medical device, using a constrictor, in accordance with some exemplary embodiments of the invention.

[0285] At 1002, an implantable medical device directed for deployment within a blood vessel, is provided. In some embodiments of the invention the implantable medical device is a deformable tubular wall. Alternatively, or additionally, the implantable medical device comprises an inner deformable tubular wall for blood flow therethrough, with an optional outer wall for anchoring in the blood vessel.

[0286] At 1004, a constrictor is mounted on the deformable tubular wall. In some embodiments of the invention the deformable tubular wall is provided with the constrictor mounted thereon (e.g., manufactured and packaged). Alternatively or additionally, a physician or other operator may apply the constrictor on to the deformable tubular wall, for example, just before surgery.

[0287] In some embodiments of the invention, the assembly of the constrictor and / or the adjustment of the initial diameter requires a force for overcoming the geometric interference for passing the filament through the lock, resulted in a slow and controlled movement of the filament through the lock. This has the potential advantage of enhancing the control and / or accuracy when adjusting the pre-set diameter.

[0288] In some embodiments of the invention the assembly of the constrictor includes moving the filament through the lock in steps, having the potential advantage of controlled and / or measured adjustment of the pre-set diameter.

[0289] In some embodiments of the invention, the number of radially protruding sections defines the number of steps along the movement of the filament through the lock, and / or the number of possible locking positions.

[0290] In some embodiments of the invention the force required to assemble the constrictor is equal to the force required to adjust the diameter thereof. Alternatively, the force required to assemble the constrictor is greater from the force required to adjust the diameter thereof.

[0291] In some embodiments of the invention, the filament comprises smaller radial protruding sections at proximity to the end of the filament, having the potential advantage of easing the assembly of the constrictor, alternatively or additionally, the filament diameter at proximity to the end thereof is relatively smaller compared to the rest of the filament.

[0292] In some embodiments of the invention, the selected constrictor is chosen according to the intended site of implantation. The activation force to overcome the geometric interference to movement between the filament and the lock of the constrictor is greater than the forces that the constrictor will experience at the implantation site.

[0293] At 1006, a pre-set constriction is determined by reducing the effective diameter of the implantable device. The constrictor is tightened around the implantable medical device so that the diameter of the closed shape is reduced compared to the natural diameter of the implantable medical device. The implantable medical device is thus radially collapsed to form a narrow radial neck thereof.

[0294] Optionally or alternatively, the constrictor is not tightened enough to cause the implantable medical device to collapse, forming only a potential narrowing.

[0295] Optionally, the level of constriction can be further adjusted if and / or when required prior and / or during and / or after deployment within a blood vessel.

[0296] At 1008, the medical implantable device including the constrictor, is deployed within a blood vessel.

[0297] At 1010, optionally, the level of constriction is adjusted during and / or after deployment. The level of constriction can be reduced and / or enhanced according to need. The number of adjustments that can be done is not limited by amount and / or by time.

[0298] The adjustment requires a force for overcoming the geometric interference between the filament and the lock. The force optionally varies as each "step" is taken (e.g., due to varying resistance of a bent section). This has the potential advantage of enhancing the controlled and / or accuracy when adjusting the reduced diameter during and / or after deployment.

[0299] In some embodiments of the invention, the free length of the filament is pulled to increase the constriction and / or pushed to reduce the constriction. Alternatively or additionally, an inflatable balloon or other expandable device is inserted into the inner lumen of the implantable medical device, applying sufficient pressure to cause the constrictor to open.

[0300] In some embodiments of the invention, a kit of noncompliant balloons is used to decrease the constriction in steps. In some embodiments, the kit includes a plurality of noncompliant balloons, each having a different diameter. In some embodiments, more than one of the noncompliant balloons are inserted into the lumen of the implantable medical device and inflated therein, in a growing sequence of diameter (e.g., diameter at the inflated state).

[0301] In some embodiments, the differences between the diameters of the inflated noncompliant balloons define the size of the steps. In some embodiments, the differences are constant, defining a uniform step size. Alternatively or additionally, the differences are varying, defining changing step size. For example, in some embodiments, as the diameter of the noncompliant balloon decreases, the difference between the diameters of the non-compliant balloons decreases, having the potential advantage of enhancing sensitivity for minor constriction release. Another example is first inserting non-complaint balloons with relatively large differences between the diameters thereof, to obtain large steps, and then inserting non-complaint balloons with relatively minor differences between the diameters thereof, for potentially increasing the sensitivity of the gradual constriction release and / or for fine-tuning the modified dimensions of the constrictor.

[0302] In some embodiments, the required release of constriction is known, so a specific non- compliant balloon having a diameter to achieve the desired decreased constriction, is used.

[0303] In some embodiments, the kit comprises balloons with diameters from 7 mm to 16 mm, where the diameters optionally differ by 0.5 mm. In some embodiments, a balloon with a diameter of 16 mm fully opens the constriction. Alternatively or additionally, the kit comprises balloons with diameters from 7 mm to 10 mm, where the diameters optionally differ by 0.5 mm, and a balloon with a diameter of 16 mm to fully open the constriction.

[0304] In some embodiments the kit can be used to open a constrictor, having a filament that moves continuously within the lock (e.g., constrictor 700, shown in figures 7A-B, and / or constrictor 900 shown in figures 9A-B), so that the insertion of more the one noncompliant balloon into the inner lumen of the medical device in growing sequence of diameter defines the constriction decrease in steps.

[0305] In some embodiments the kit can be used to open a constrictor, having a filament that moves in steps within the lock (e.g., constrictors 400, 500 and 600 shown in figures 4-6). In some embodiments, the step size(s) defined by the kit matches the step size(s) defined by the constrictor. Alternatively or additionally, the kit defines step size(s) which are unlike the step size(s) defined by the constrictor.

[0306] In some embodiments, the kit comprises at least one noncompliant balloon and a constrictor (e.g., constrictor 400, 500, and / or 600) which comprises a filament with ascending resistance to movement of the filament within the lock, in the opening direction of the constrictor. For example, the radially protruding sections (e.g., sections 403, 503, or 603), are arranged in ascending order of size and / or height. In another example, radially protruding bent sections (e.g., sections 503) are arranged in ascending bending level (e.g., ascending order of bent section’s height and / or slope) in the opening direction of the constrictor. The kit further comprises instructions, indicating which pressure should be applied for opening the constrictor to a certain diameter, (i.e. which pressure is required to overcome a certain resistance). For example, the instructions are presented in the form of a table correlating different pressures with resulting diameters. It should be noted that in some applications the at least one noncompliant balloon is separate from the constrictor. In some embodiments, the at least one balloon can be used to increase the effective diameter of a deformable tubular wall which does not have a constrictor mounted thereon. In some embodiments, the at least one balloon can be used to gradually enlarge the inner lumen of a deformable tubular wall by deforming the shape of the deformable tubular wall. In some embodiments, a plurality of non-complaint balloons is inserted into the inner lumen and inflated therewithin in increasing sequence of inflated diameters. For example, the kit can be used to open the narrowing of an hourglass- shaped deformable tubular wall.

[0307] In some embodiments of the invention, the geometrical interference and elasticity of the lock and filament are selected so that the force applied for moving the filament through the lock is insufficient to dislodge the implantable medical device. For example, such force (as applied to the filament by pulling) may be less than 2Kg, IKg, 500grams, 200grams, 50 grams and smaller or intermediate forces.

[0308] In some embodiments of the invention the adjustment of the constrictor includes movements of the filament through the lock in steps, having the potential advantage of controlled and / or measured adjustment of the reduced diameter during and / or after deployment. Various physiological measurements may be made at each step to assess if a correct constriction is achieved. Optionally or additionally, the bends or thickenings in the constricting filament may be visible using imaging (e.g., x-ray or ultrasound). This may help in confirming the actual constriction amount.

[0309] In some embodiments of the invention the geometric interference between the filament and the lock generates tactile feedback due to the stepped movement of the filament through the lock. A potential advantage of this tactile feedback is an indication for the level of adjustment of a deployed implantable medical device and / or avoiding of over and / or under adjustment.

[0310] At the end of the adjustment the free length of the filament is optionally released to allow the implantable medical device to rest in the new adjustment constriction level. In some embodiments of the invention, pulling comprises pulling on both filament ends.

[0311] Referring now to Figures 11A-B, showing perspective views of a constrictor 1100 comprising at least one stopper 1110 / 1111 having at least one radial protruding direction that protrudes more than at least one other radial directions, in accordance with some exemplary embodiments of the invention.

[0312] Also referring to Figure 11C, showing a front view of a constrictor 1100 comprising at least one stopper having at least one radial protruding direction that protrudes more than at least one other radial direction, in accordance with some exemplary embodiments of the invention

[0313] Also referring to Figure 12, showing a perspective view of a stopper having at least one radial protruding direction that protrudes more than at least one other radial directions, in accordance with some exemplary embodiments of the invention. Constrictor 1100 may be an example implementation of constrictor 400 and stoppers 1110 / 1111 may be a variant of stoppers 210 / 211.

[0314] In some embodiments, stopper 1110 / 1111 is shaped to radially protrude from the crosssection of inner lumen 1105 in at least one radial direction, optionally, in two opposite radial directions (e.g., at an angular distance of 180 degrees). In some embodiments, stopper 1110 / 1111 comprises an oblong cross-section (e.g., shaped to be longer in one direction than the other, optionally with rounded edges), such as an elliptical and / or rectangular cross- section. In some embodiments, stopper 1110 / 1111 comprises a tubular body, having an oblong crosssection. In some embodiments, the length of the oblong shape is larger than the opening of inner lumen 1105. The extent of the radial protrusion(s) (e.g., length of the oblong shape) is shaped and / or sized to potentially prevent the stopper from partially and / or fully entering, and / or moving within lock 1104. The entrance and / or movement of stopper 1110 / 1111 within lock 1104 might result in an expansion of inner lumen 1105 and / or in constrictor 1100 being erroneously opened.

[0315] In some embodiments, stopper 1110 / 1111 comprises at least one less radially protruding direction. Optionally this radial direction(s) are perpendicular to the at least one radial protruding direction. For example, the width of the oblong shape is perpendicular to the length thereof. In some embodiments, the at least one less radially protruding direction does not protrude, substantially does not protrude and / or minimally protrudes beyond the cross-section of filament 1102. The reduced protrusion in this direction potentially reduces and / or avoids wedging and / or distortion of a portion of filament 1102 adjacent to stopper 1110 / 1111. Additionally, this reduced protrusion potentially reduces and / or avoids interference with the movement of a portion of filament 1102 next to stopper 1111. This reduced and / or lack of interference with the filament potentially allows the at least one protruding direction to protrude relatively significantly, having the potential advantage of reducing and / or preventing the undesired entry and / or movement of stopper 1110 / 1111 within lock 1104 upon being subjected to relatively high forces and / or if stopper 1110 / 1111 and / or lock 1104 are made of relatively deformable materials.

[0316] In some embodiments, stopper 1110 / 1111 is an add-on component that is connected to the end of filament 1102. For example, in some embodiments, stopper 1110 / 1111 may be welded to the end of filament 1102 and / or to an end portion of filament 1102.

[0317] In some embodiments, stopper 1110 / 1111 defines the effective end of filament 1102. For example, stopper 1110 / 1111 may be positioned on the filament at a location distant from its actual end, effectively limiting the filament's movement to the point where stopper 1110 / 1111 engages with lock 1104. In some embodiments, stopper 1110 / 1111 is produced by cutting a tube, optionally an oblongshaped tube. In some embodiments, stopper 1110 / 1111 is produced from a dedicated flat plate. These production methods potentially allow for enhanced control over the size and / or shape of stopper 1110 / 1111, for example, by selecting a tube having the desired size and / or shape.

[0318] In some embodiments, stopper 1110 / 1111 is formed by shaping the end of filament 1102. For example, by folding the filament's end and fixing it in a folded position, and / or by forming a sphere at the end and deforming it to achieve an oblong shape.

[0319] In some embodiments, stopper 1110 / 1111 comprises a stopper lumen 1120 aligned with its longitudinal axis, optionally, centrally positioned with respect to the cross-section thereof. In some embodiments, stopper lumen 1120 is sized and / or shaped to receive and / or accommodate filament 1102. In some embodiments, stopper lumen 1120 defines one or more relatively thin wall portions of the stopper 1110 / 1111 (e.g., along the width of the oblong shape) and one or more relatively thick wall portions of the stopper 1110 / 1111 (e.g., along the length of the oblong shape).

[0320] In some embodiments, stopper 1110 / 1111 comprises two aligned openings for filament 1102 to pass therethrough. In some embodiments stopper 1110 / 1111 comprises a single opening for filament 1102 to enter the stopper therethrough.

[0321] In some embodiments, the end of filament 1102 is fixed to stopper 1111 / 1110, optionally, after being passed therethrough, optionally by welding the end of filament 1102 to stopper 1111. Stopper 1111 / 1110 and filament 1102 may be welded at both ends of the stopper 1122 and / or

[0322] 1124, or at either end of the stopper, optionally at the exterior (e.g., outer surface) of the stopper

[0323] 1125.

[0324] In some embodiments, the proximal surface at proximal end 1122 (e.g., the surface facing lock 1104) of stopper 1110 / 1111 is concave and optionally the distal surface at distal end 1124 is convex or concave as well. The concave proximal surface may potentially reduce the risk of the stopper bending and / or entering lumen 1105. In some embodiments, the proximal surface 1122 is convex and optionally the distal surface 1124 is concave or convex as well. In some embodiments, at least one of the stopper’s distal surface 1124 and / or proximal surface 1122 is flat.

[0325] In some embodiments, the length of filament 1102 defines the diameter of closed shape 1108 (e.g., the maximum diameter of closed shape 1108). In some embodiments, the filament length (either before and / or after treatment to create radially protruding sections 1103) may be selected to achieve a desired maximum diameter of closed shape 1108, such that different lengths may be selected for different desired diameters. In some embodiments, the length of filament 1102 is selected to obtain a maximum diameter of closed shape 1108 of about about 7-10 mm, for example, 6.5-8 mm, or 8-9.5 mm, or 10-11 mm or about 8 mm, or lower or higher or intermediate ranges or diameters.

[0326] In some embodiments, the length of filament 1102 and / or the number and / or locations of the radially protruding sections 1103 thereon define the possible diameters (e.g., constrict diameters) of closed shape 1108. In some embodiments, constrictor 1100 comprises a single protruding section 1103, optionally defining two constriction levels (e.g., constricted and unconstricted). In some embodiments, the single protruding section 1103 is positioned along filament 1102 to achieve a desired constricted diameter. In other embodiments, constrictor 1100 comprises more than one protruding sections 1103, optionally defining a plurality of constriction levels. It should be noted that, although the figure shows a single radially protruding section 1103, it is a representation of one or more radially protruding sections that may be present on a portion of filament 1102. In some embodiments, a constrictor is manufactured and / or selected based on a desired constricted diameter, a range of constricted diameters, and / or numbers of constricted diameters (e.g., numbers of movement steps).

[0327] In some embodiments, radially protruding sections 1103 are located and / or spread along an end portion of filament 1102, such that the portion of filament 1102 comprises the radially protruding sections 1103 defines the maximum length of tail 1106. For example, the protruding section most distanced from the end of filament 1102 and / or stopper 1110 (e.g., the most proximal protruding section), defines the maximum length of tail 1106.

[0328] In some embodiments, the length of filament 1102 and / or tail 1106 should be sufficiently long to allow the diameter of closed shape 1108 to be opened to a diameter equal to, substantially equal to, similar to, or slightly greater than the unconstricted diameter of tubular wall 100. This allows tubular wall 100 to be open to its unconstricted position after expansion (e.g., full expansion) of constrictor 1100, for example, by using noncompliant balloon(s).

[0329] In some embodiments, the length of filament 1102 and / or tail 1106 should be sufficiently long such that even when constrictor 1100 is opened to the unconstricted diameter of tubular wall 100, constrictor 1100 comprises tail 1106, optionally, a relatively short remaining tail. This remaining tail may be bare of radially protruding sections 1103 and / or comprise radially protruding sections 1103. This short remaining tail potentially prevents stopper 1110 from reaching lock 1104, having the potential advantage of further reducing the risk of closed loop 1108 being undesirably and / or erroneously opened and / or disassembled. In some embodiments, stopper 1110 is positioned at the end of this remaining tail, for potentially further securing constrictor 1100 from being undesirably disassembled. Referring now to Figure 13A, showing a perspective view of a constrictor 1300 comprising at least one stopper 1310 / 1311, a filament 1302 attached to stopper 1310 / 1311 such that the stopper 1310 / 1311 exposes a portion 1303 the filament 1302, in accordance with some exemplary embodiments of the invention.

[0330] Also referring to Figure 13B, showing a fractional side view of a constrictor 1300 comprising at least one stopper 1310 / 1311, a filament 1302 attached to stopper 1310 / 1311 such that the stopper 1310 / 1311 exposes a portion 1303 the filament 1302, in accordance with some exemplary embodiments of the invention.

[0331] Also referring to Figure 13C-D, showing a perspective view of a stopper 1310 / 1311 that exposes a portion of filament 1302 attached thereto, in accordance with some exemplary embodiments of the invention.

[0332] Constrictor 1300 may be an example implementation of constrictor 400 and stoppers 1310 / 1311 may be a variant of stoppers 210 / 211 and / or stoppers 1110 / 1111.

[0333] In some embodiments, stopper 1311 (e.g., the stopper adjacent and / or fixed to lock 1304) comprises a missing segment 1320, optionally a radial missing segment and / or any other missing segment that exposes a portion of filament 1303. In some embodiments, the missing segment 1320 exposes a portion of the filament surface along the longitudinal axis thereof, such that filament 1302 passing through and / or inserted to stopper 1311 is partially circumferentially surrounded by stopper 1311. The missing segment 1320 is shaped and / or sized to allow the stopper to grip the filament and / or potentially prevent the filament from radially dislodging (e.g., detaching) from the stopper, while also providing the exposed area (e.g., exposed portion) 1303 of the filament.

[0334] In some embodiments, stopper 1311 is oriented such that the exposed portion of filament 1303 (e.g., not surrounded by stopper 1311) is adjacent to another portion of filament 1302 passing through lock 1304. The adjacency of exposed portion 1303 to the other portion of the filament potentially further reduces and / or avoids undesired interactions of stopper 1311 with the filament passing through lock 1304, such as wedging and / or distortion of filament 1302 and / or interference with movement of filament 1302. In some embodiments, stopper 1310 (e.g., at the end of the filament-free tail 1306) may comprise a missing segment as stopper 1311. In other embodiments, stopper 1310 may have the unsegmented form, for example, as shown for stopper 1111 / 1110. In some embodiments, stopper 1310 may have the same wall thickness in any radial direction. In some embodiments, the geometry (e.g., cross- section) of stopper 1311 may be shaped to radially protrude to the same extent in all un-segmented directions. For example, the crosssection may be shaped as a segmented ellipse circule and / or crescent shape. In some embodiments, the cross-section of stopper 1311 may be shaped to protrude more in one or more radial directions, other than the direction of the missing segment. For example, the cross-section may be shaped as a segmented ellipse.

[0335] In some embodiments, the cross-section of stopper 1311 is shaped to protrude more in one or more directions other than the radial direction of the missing segment. Alternatively or additionally, the cross-section of stopper 1311 is shaped to protrude more in the radial direction opposite to the missing segment. In some embodiments, the cross-section may be shaped as an oblong shape with a radial missing segment on one side of the width thereof. In some embodiments, the cross-section of the stopper 1311 is sized and / or shaped so that at least a portion thereof (e.g., diameter) is larger than the opening of the inner lumen, for example, as described for stopper 1111 / 1110.

[0336] In some embodiments, the diameter and / or the larger diameter of stopper 1311 / 10 and / or stopper 1111 / 10 does not extend, and / or substantially does not extend beyond the perimeter of 1326 / 1126 lock 1304 and / or 1104. This design potentially facilitates the crimping of an implantable medical device (e.g., implantable medical device 300 and / or tubular wall 100) comprising constrictor 1100 and / or 1300, and its loading into a delivery system (e.g., delivery catheter). An additional potential advantage may be reducing and / or avoiding protruding toward the vessel wall which might result in injury of the vessel wall tissue. For example, in some embodiments, the diameter and / or larger diameter of the cross-section is equal and / or substantially equal to the crosssection of inner lumen 1305 and / or 1105 together with the crosssection of the walls of lock 1304 and / or 1104. In some embodiments, since two portions of filament 1302 and / or 1202 are inserted through the lock 1304 and / or 1104 the effective opening diameter of inner lumen 1305 / 1105 is reduced so that the diameter of the stopper 1311 and / or 1111 / 10 can be smaller than the diameter of the inner lumen opening.

[0337] In some embodiments, the diameter and / or the larger diameter of the stopper 1311 / 1310 and / or 1111 / 1110 may extend beyond the perimeter 1326 / 1126 of lock 1304 / 1104, potentially enhancing the stopper resistance to enter lock 1304 / 1104.

[0338] In some embodiments, stopper 1110 / 1111 is produced by cutting (e..g, laser cutting) a tube, optionally an oblong-shaped tube. In some embodiments, missing segment 1320 of stopper 1310 is formed by laser cutting a segment from a tube or flat plate. In some embodiments, the surface and / or edges of stopper 1311 / 1310 and / or stopper 1111 / 1110 are round and / or smooth to potentially reduce the fraction between the filament (e.g., 1302 and / or 1102). In some embodiments, the filament surface is smooth and / or rounded as well, to potentially further reduce the friction between the filament and stopper 1311 / 1310 and / or stopper 1111 / 1110 and / or to reduce the friction between filament portions. The reduced friction potentially reduces rotation and / or twisting of lock 1304 and / or 1104 out of a desired orientation, for example, if stopper 1311 and / or 1111 is not fixed to the lock (e.g., 1304 and / or 1104). Additionally, the reduced friction potentially reduces the risk of a filament portion passing through lock 1304 and / or 1104 and causing unintended tightening, loosening, or opening of the constriction, by dragging the stopper 1311 / 1310 and / or 1111 / 1110 into or away from the lock.

[0339] In some embodiments, a portion of the stopper’s surface 1318 defining missing segment 1320 is smooth and / or rounded and / or has a smooth and / or rounded rim (e.g., edges). This surface 1318 (and / or edges) contacts and / or faces an adjacent portion of filament 1302. The smooth and / or rounded surface and / or rim potentially reduces friction with the adjacent portion of the filament 1302, moving and / or resting near stopper 1311, whether stopper 1311 is fixed to lock 1304 and / or free to rotate.

[0340] It is expected that during the life of a patent maturing from this application many relevant filaments will be developed; the scope of the term filament is intended to include all such new technologies a priori.

[0341] As used herein with reference to quantity or value, the term “about” means “within ± 10 % of’.

[0342] The terms “comprises”, “comprising”, “includes”, “including”, “has”, “having” and their conjugates mean “including but not limited to”.

[0343] The term “consisting of’ means “including and limited to”.

[0344] 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.

[0345] As used herein, the singular forms “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.

[0346] Throughout this application, embodiments of this invention may be presented with reference to 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.

[0347] Whenever a numerical range is indicated herein (for example “10-15”, “10 to 15”, or any pair of numbers linked by these another such range indication), it is meant to include any number (fractional or integral) within the indicated range limits, including the range limits, unless the context clearly dictates otherwise. The phrases “range / ranging / ranges between” a first indicate number and a second indicate number and “range / ranging / ranges from” a first indicate number “to”, “up to”, “until” or “through” (or another such range-indicating term) 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 numbers therebetween.

[0348] 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

[0349] 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.

[0350] 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.

[0351] General

[0352] 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.

[0353] 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.

[0354] 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 medical device for implantation in a blood vessel, with an adjustable diameter, comprising;(a) a deformable tubular wall; and(b) a constrictor, comprising:(i) a filament, comprises a plurality of radially protruding sections; and(ii) a hollow lock, comprises an inner lumen, wherein the filament is inserted to the inner lumen of the hollow lock and a portion of the filament is mechanically coupled to the hollow lock, forming a closed shape, wherein the constrictor surrounds circumferentially at least a portion of the deformable tubular wall.

2. A medical device for implantation in a blood vessel, according to claim 1, wherein there is a geometric interference to the passage of the plurality radially protruding sections through the inner lumen of the hollow lock, and at least one of the filament and hollow lock is formed from a material that upon sufficient applied force pulling the filament can reversibly deform to allow the passage of the filament trough the hollow lock.

3. A medical device for implantation in a blood vessel, according to claim 1, wherein the radially protruding sections are bent sections of the filament.

4. A medical device for implantation in a blood vessel, according to claim 3, wherein the bent sections have a triangular shape.

5. A medical device for implantation in a blood vessel, according to any of claims 1-4, wherein the filament comprises Nitinol, and wherein the Nitinol is pre-treated to include the radially protruding sections.

6. A medical device for implantation in a blood vessel, according to any of claims 1-5, wherein the diameter of the filament is sufficiently small for pre-treatment, including bending, to result in radially protruding sections, and sufficiently large for avoiding breakage of the filament when straightened through the hollow lock.

7. A medical device for implantation in a blood vessel, according to any of claims 1- 6, wherein the diameter of the filament is between 0.1-0.3 mm.

8. A medical device for implantation in a blood vessel, according to any of claims 1- 4, wherein the radially protruding sections have a radial extent greater than the inner lumen of the hollow lock.

9. A medical device for implantation in a blood vessel, according to any of claims 1-8, wherein at least one of the filament and hollow lock are deformable.

10. A medical device for implantation in a blood vessel, according to any of claims 1-9, wherein the radially protruding sections are steeper in one axial direction along the filament than in an opposite axial direction along the filament.

11. A medical device for implantation in a blood vessel, according to any of claims 1-10, wherein the required force for passing the filament through the hollow lock is different for movements in one relative direction compared to relative movement in an opposite direction.

12. A medical device for implantation in a blood vessel, according to claim 11 wherein the force is greater for reducing the constriction.

13. A medical device for implantation in a blood vessel, according to any of claims 1- 12 wherein the hollow lock comprises a rounded rim at an entrance of the filament thereto.

14. A medical device for implantation in a blood vessel, according to claim 13, wherein said inner lumen has with a fixed inner diameter.

15. A medical device for implantation in a blood vessel, according to claim 13, wherein said inner lumen has a non-uniform inner cross-section.

16. A medical device for implantation in a blood vessel, according to any of claims 1- 15, wherein at least one radially protruding section comprises a thickening of the filament.

17. A medical device for implantation in a blood vessel, according to claim 16, wherein the thickening is symmetric around the filament axis.

18. A medical device for implantation in a blood vessel, according to any of claims 1- 17, wherein said mechanical coupling comprises geometric interference between a thickening of the filament and the inner lumen.

19. A medical device according to claim 18, wherein said thickening comprises a spherical shape.

20. A medical device for implantation in a blood vessel, according to any of claims 1- 19, wherein said lock is elongated and aligned with said filament around a circumference of said tubular wall.

21. A medical device for implantation in a blood vessel, according to claim 19, wherein said lock is has a maximal outer diameter of less than 1 mm, a maximal inner diameter of less than 0.5 mm, and said filament has an outer diameter of less than 0.25 mm.

22. A medical device for implantation in a blood vessel, according to any of claims 1- 21, comprising at least one stopper positioned at an end of said filament.

23. A medical device for implantation in a blood vessel, according to claim 22, wherein the at least one stopper is shaped to radially protrude more in one or more radial directions than in one or more other radial directions.

24. A medical device for implantation in a blood vessel, according to claim 23, wherein the one or more other radial directions are facing an adjacent portion of the filament.

25. A medical device for implantation in a blood vessel, according to any of claims 22-24, wherein at least one stopper of said at least one stopper comprises an oblong shape having a length larger than the opening of the lock and a width larger than the diameter of the filament and smaller than the opening of the lock.

26. A medical device for implantation in a blood vessel, according to any of claims 22-25, wherein the at least one stopper comprises a missing segment, configured to expose a portion of the filament passing through the stopper.

27. A medical device for implantation in a blood vessel, with an adjustable diameter, comprising;(a) a deformable tubular wall; and(b) a constrictor, comprising:(i) a filament; and(ii) a hollow lock, comprises an inner lumen with at least one narrowed section, wherein the filament is inserted into the inner lumen of the hollow lock and a portion of the filament is mechanically coupled to the hollow lock, forming a shape, surrounding circumferentially at least a portion of the deformable tubular wall.

28. A medical device for implantation in a blood vessel, according to claim 27, wherein the diameter of the filament is larger than the diameter of the at least one narrowed section.

29. A medical device for implantation in a blood vessel, according to claim 27, wherein the filament comprises radially protruding sections which a diameter larger than the diameter of the at least one narrowed section, while said filament between said sections has a diameter smaller than that of said narrow section.

30. A medical device for implantation in a blood vessel, according to claim 29, wherein said radially protruding sections are deformable.

31. A medical device for implantation in a blood vessel, according to any of claims 27-30, wherein at least one of the filament and hollow lock are deformable.

32. A medical device for implantation in a blood vessel, according to claim 27, wherein the narrowed inner lumen obstructs the passage of the filament through the hollow lock.

33. A medical device for implantation in a blood vessel, according to any of claims 27-32, wherein the reduced inner lumen includes axially separated narrowed sections.

34. A medical device for implantation in a blood vessel, according to any of claims27-33, wherein the reduced inner lumen is defined by one or more intrusions of a wall of said hollow lock into said inner lumen.

35. A medical device for implantation in a blood vessel, with an adjustable diameter, comprising:(a) a deformable tubular wall; and(b) a constrictor, comprising: a filament, tied in the form of a sliding knot having a loop movable along the filament by pulling on ends of the filament, forming a shape, surrounding circumferentially at least a portion of the wall.

36. A method of controlling the diameter of a deformable tubular wall of a medical implant, comprising(a) pulling on a filament surrounding said tubular wall with sufficient force to deform one or both of said filament and hollow lock to allow relative movement therebetween and a hollow lock mounted on said filament and insufficient to dislodge said medical implant;(b) releasing said filament to allow the medical implant to rest in a new, more constricted shape; and(c) repeating said (a) and (b).

37. A method according to claim 36, comprising pushing said filament towards said implant, with sufficient force to provide relative movement between said filament and said hollow lock in a direction opposite to (a).

38. A method according to claim 36, comprising increasing an inner diameter of said deformable tubular wall by expanding an expansion device inside said wall with sufficient pressure to cause relative movement between said filament and said hollow lock in a direction opposite to (a).

39. A method according to claim 38, wherein the expansion device is a non-complaint medical balloon.

40. A method according to any of claims 38-39, wherein increasing comprises increasing in steps due to modulated resistance of said hollow lock to movement of said filament.

41. A method according to any of claims 36-40, wherein said pulling causes a straightening of at least one bent section in said filament adjacent or in said hollow lock.

42. A method according to any of claims 36-41, wherein (c) defines step-wise movement due to said pulling being characterized by modulated resistance of said hollow lock to movement of said filament.

43. A kit for gradually expanding the effective diameter of a deformable tubular wall comprising a at least one noncompliant balloon.

44. A kit according to claim 43, comprises instructions on how to use the noncompliant balloon to achieve a specific diameter.

45. A kit according to claim 44, wherein the instructions comprise a specification of at least one atmospheric pressure required to achieve at least one specific diameter.

46. A kit according to any of claims 43-45, wherein the at least one noncompliant balloon is a plurality of noncompliant balloons of different inflated diameters.

47. A method for gradually expanding the effective diameter of a deformable tubular wall having a constrictor mounted thereon, by using a kit of noncompliant balloons, wherein the deformable tubular wall comprises a wall and an inner lumen having an initial effective diameter, wherein the method comprises: a) inserting a first noncompliant balloon into the lumen, having a first inflated diameter; b) inflating the first noncompliant balloon within the lumen, wherein the first inflated diameter is larger than the initial effective diameter of the lumen, and wherein the first noncompliant balloon is applying pressure onto the wall of said deformable wall from within the lumen, to deform the wall and partially open the constrictor to obtain a second effective diameter of the lumen, wherein the second effective diameter is larger than the initial effective diameter; c) inserting a second noncompliant balloon into the lumen, having a second inflated diameter larger than the first inflated diameter of the first noncompliant balloon; d) inflating the second noncompliant balloon within the lumen.

48. A method according to claim 47, wherein the method further comprises repeating steps c-d at least one time, wherein the repeating comprises inserting a noncompliance balloon with an inflated diameter larger than a previous noncompliance balloon.

49. A method according to any of claims 47-48, wherein the constrictor is accordingf claims 1-30.

50. A method according to any of claims 47-49, wherein the kit is according to claim

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