Thermomechanical polymer tube for dilation tool, a dilation tool, and manufacturing method thereof

Abstract

The present invention provides a novel dilation tool for a balloon catheter, balloon catheters comprising such dilation tool, method of fabrication them, and uses and methods of treatment utilizing them.

Description

[0001] BIOMICRO-OOl PCT

[0002] THERMOMECHANICAL POLYMER TUBE FOR DILATION TOOL, A DILATION TOOL, AND MANUFACTURING METHOD THEREOF

[0003] TECHNICAL FIELD

[0004]

[0001] The present invention relates to medical devices, and more particularly, to dilation tools, such as balloon catheters, and a method of manufacturing the same. More specifically, the inveniton concerns a method for fabricating non-compliant balloons directly on catheter shafts using thermomechanical properties of polyester (PET) tubing without the need for molds or bonding. The invention is particularly applicable to micro -dilation procedures, such as for treating Chronic Total Occlusions (CTO) in coronary and peripheral arteries.

[0005] BACKGROUND

[0006]

[0002] Balloon catheters are well known. Medical balloons, such as angioplasty catheter balloons, may be divided into two major groups: 'non-compliant balloons' and 'compliant balloons'. With compliant balloons, the size of the balloon is directly proportional to the inflation pressure, whereas with non-compliant balloons, the balloon inflates to a specific predetermined length and diameter.

[0007]

[0003] US 7,749,585 and US 6,656,550 recite the production of a compliant pre-manufactured and treated non-compliant polymer tubular balloon. They further disclose a method for the manufacture and treatment of a polymer tube balloon having a wall thickness reduction over a portion of the length of the balloon.

[0008]

[0004] Conventional balloon catheters used in procedures such as Percutaneous Transluminal Coronary Interventions (PTCI) require precise balloon formation with strict dimensional control. Non-compliant balloons are particularly valued for their resistance to diameter expansion under pressure, ensuring precise vessel dilation.

[0009]

[0005] Current manufacturing methods typically require: independent molding of balloons; bonding of balloons to catheter shafts; and / or complex processing steps, including adhesive use or thermal welding. However, these methods increase manufacturing complexity, introduce potential points of failure, and elevate production costs. BIOMICRO-OOl PCT

[0010]

[0006] There exists a need for a simplified, integrated process for producing non-compliant balloons with minimal variability and fewer assembly steps.

[0011]

[0007] It would therefore be advantageous to provide a non-compliant dilation balloon made from off-the-shelf material that does not require manufacture and treatment. It would also be advantageous to provide such a non-compliant dilation balloon, or catheter balloon which is deformed from the initial state of the material into the plastic range, engages a lesion, and is operative by being inflated for returning first to the initial state and thereafter to the elastic range.

[0012] SUMMARY OF INVENTION

[0013]

[0008] In a first aspect, the present invention provides a dilation tool 10 for a balloon catheter, the dilation tool 10 comprises an inflation tube 20 associated with a polymer tube 40, wherein: (i) the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and (ii) upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD.

[0014]

[0009] In another aspect, the present invention provides a dilation tool 10 for a balloon catheter, the dilation tool 10 comprises (i) an inflation tube 20 having an inflation lumen 22 and at least one inflation aperture 24; and (ii) a polymer tube 40 coupled to the inflation tube 20 and forming a hermetically sealed inflatable dilation envelope 42, wherein the polymer tube 40 has an initial state and an initial exterior diameter OD, and is configured to exhibit a dualphase inflation behavior such that: (a) upon inflation with a fluid at a first pressure range Pa, the dilation envelope 42 inflates in a compliant manner, returning from a pre-stretched state to substantially its initial exterior diameter OD, and further into a plastic deformation range BIOMICRO-OOl PCT beyond said initial exterior diameter OIP. and (b) upon continued inflation with said fluid at a second pressure range Pb, higher than said first pressure range Pa, the dilation envelope 42 inflates in a non-compliant manner into an elastic deformation range, wherein its exterior diameter (DMax) increases by about 5% to 10% beyond said initial exterior diameter OD.

[0015]

[0010] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the inflation of the inflation tube 20 results in an increase in its diameter and a decrease in its length.

[0016] [Oil] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the inflation tube 20 comprises at least one inflation aperture 24 configured to control a direction of inflation of the dilation envelope 42 in at least one of a distal direction, a proximal direction, or both, thereby enabling inflation of the dilation envelope 42 to proceed in controlled inflation distance steps si along the inflation tube 20, away from the at least one inflation aperture 24. In specific embodiemnts thereof, the at least one inflation aperture 24 is selected as one out of at least one axial inflation aperture, at least one radial inflation aperture, and at least one axial and one radial inflation aperture 24.

[0017]

[0012] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the polymer tube 40 is selected from the group consisting of Polyurethane (PU), Thermoplastic Polyurethane (TPU), Polyethylene Terephthalate Glycol (PETG), Polyvinyl Chloride (PVC), and Polycaprolactone (PCL). In specific embodiments, the polymer tube 40 is polyethylene terephthalate (PET).

[0018]

[0013] In specific embodiments of the dilation tool 10 according to any of the embodiments above: (i) the polymer tube 40 is hermetically sealed to the inflation tube 20 at a proximal fixation point XP, and at a distal fixation point XD (ii) the at least one inflation aperture 24 is disposed between said proximal XP and distal XD fixation points; and (iii) inflation of the dilation envelope 42 proceeds in at least one direction out of a distal, a proximal, or both a distal and a proximal direction, respective to a disposition of the proximal fixation point XP and of the at least one inflation aperture 24.

[0019]

[0014] In certain embodiments, the dilation tool 10 according to any of the embodiments further comprises an internal coil housed within the dilation envelope 42, wherein BIOMICRO-OOl PCT pressurization and deflation of the dilation envelope 42 cause said coil to extend a guidewire forward (e.g., through occlusions). In specific embodiments, the internal coil is constructed from a radiopaque material and is configured to compress axially and contract radially upon inflation, thereby increasing its local radiographic density for real-time visual confirmation of balloon expansion under fluoroscopy.

[0020]

[0015] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the hermetically sealed inflatable envelope 42 is configured for in situ successive repetition of inflation procedures. In specific embodiments, a guidance tool 80 is configured to return a deflated portion or an entirety of the dilation envelope 42 into an operative condition, i.e., a prior-to-inflation condition, after a prior inflation. In further specific embodiments, the guidance tool 80 comprises an inlet funnel 82 configured to mechanically restore the deflated portion of the dilation envelope 42 to a first deformation state.

[0021]

[0016] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the disposition in an operative position and guidance to a target location is carried out using unassisted guidance, a guide wire GW guidance, or a micro-catheter 80 guidance.

[0022]

[0017] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the inflation tube 20 together with an interior guide 30 form a slider device 60 configured for bidirectional sliding within the the inflation lumen 22 in response to inflation and deflation of the dilation envelope 42. In specific embodiments, the slider device 60 comprises an interior guide 30 and / or a tubular distal rail 50.

[0023]

[0018] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the slider device 60 comprises a distal nose assembly 70.

[0024]

[0019] In certain embodiments of the dilation tool 10 according to any of the embodiments above, the dilation envelope 42 is configured to operate a single inflation or a repetitive succession of inflations.

[0025]

[0020] In certain embodiments, the dilation tool 10 according to any of the embodiments above comprises a coil designed to be positioned within said balloon catjetjer, wherein said coil is constructed from a radiopaque material, such as platinum, tungsten, or tantalum. This coil serves as both a structural element and an imaging aid. BIOMICRO-OOl PCT

[0026]

[0021] In certain embodiments, the dilation tool 10 according to any of the embodiments above is configured as a micro-dilation tool having an exterior diameter of about 0.2 mm in its preinflation state.

[0027]

[0022] In a second aspect, the present invention provides a method for manufacturing the dilation tool for a balloon catheter having a non-compliant dilation envelope 42 and an inflation tube 20 capable of increasing its outer diameter by about 5 to 10% beyond its initial exterior diameter OD, the method comprising the steps of: (a) providing an inflation tube 20; (b) providing a length of a polymer tube 40 residing in an initial state; and (c) longitudinally stretching said polymer tube 40 for deformation into a plastic range, thereby forming the polymer tube 40 into a hermetically sealed inflatable dilation envelope 42, while coupling it in fluid communication with the inflation tube 20. In specific embodiments, the dilation tool is the dilation tool 10 according to any of the embodiment above.

[0028]

[0023] In another aspect, the present invention provides a method for manufacturing a dilation tool for a balloon catheter, the method comprising the steps of: (a) providing a polymer tube 40 having an initial state and an initial exterior diameter OD'. (b) longitudinally stretching said polymer tube 40 to deform it into a first plastic deformation range, thereby reducing its exterior diameter and increasing its length; and (c) coupling the stretched polymer tube 40 to an inflation tube 20 to form a hermetically sealed inflatable dilation envelope 42 in fluid communication with the inflation tube 20. In specific embodiments, the dilation tool is the dilation tool 10 according to any of the embodiment above.

[0029]

[0024] In certain embodiments, the method according to any of the embodiments above further comprising steps: (d) inflating the dilation envelope 42 with a fluid at a first pressure range Pa to cause the dilation envelope 42 to return to substantially its initial exterior diameter OD and further inflate in a plastic deformation range; and (e) subsequently inflating the dilation envelope 42 with said fluid at a second pressure range Pb, higher than said first pressure range Pa, to cause the dilation envelope 42 to inflate into an elastic deformation range, wherein its exterior diameter increases by about 5% to 10% beyond said initial exterior diameter OD.

[0030]

[0025] In certain embodiments of the method according to any of the embodiments above, the BIOMICRO-OOl PCT polymer tube 40 is selected from the group consisting of Polyurethane (PU), Thermoplastic Polyurethane (TPU), Polyethylene Terephthalate Glycol (PETG), Polyvinyl Chloride (PVC), and Poly caprolactone (PCL). In specific embodiments, the polymer tube 40 is polyethylene terephthalate (PET).

[0031]

[0026] In certain embodiments of the method according to any of the embodiments above, step (c) further comprises the following steps: (cl) applying a heat-resistant barrier (heat shield) around a discrete segment of the stretched polymer tube 40 corresponding to an intended balloon location; (c2) exposing remaining unmasked portions of the stretched polymer tube 40 to heat to cause said unmasked portions to conform and adhere to an underlying catheter shaft, thereby sealing said unmasked portions and preventing their expansion under pressure; and (c3) pressurizing the polymer tube 40 to trigger reversion only in the masked segment, thereby forming the dilation envelope 42 directly integrated with the catheter shaft without external bonding or molding. In specific embodiments, the heat applied in step (c2) is hot air at about 120°C.

[0032]

[0027] In certain embodiments of the method according to any of the embodiments above, the dilation envelope 42 is hermetically sealed at a proximal fixation point XP and at a distal fixation point XD, between which fixation points an inflation aperture 24 is disposed.

[0033]

[0028] In certain embodiments of the method according to any of the embodiments above, the dilation envelope 42 is hermetically sealed at a proximal fixation point XP and at a distal fixation point XD between which a plurality of inflation apertures 24 are distributed.

[0034]

[0029] In certain embodiments of the method according to any of the embodiments above, the dilation envelope 42 is hermetically sealed at a proximal fixation point XP, at an intermediate fixation point XM, and at a distal fixation point XD, between which inflation apertures 24 are disposed.

[0035]

[0030] In certain embodiments of the method according to any of the embodiments above, the polymer tube 40 is first deformed into a predetermined length by longitudinal stretching and thereafter, inflation of the dilation envelope 42 by the second deformation process reduces its predetermined length. BIOMICRO-OOl PCT

[0036]

[0031] In certain embodiments of the method according to any of the embodiments above, the longitudinal stretching in step (b) radially expands the polymer tube 40 to approximately 35% of its original outer diameter.

[0037]

[0032] In certain embodiments of the method according to any of the embodiments above, the inflation of the dilation envelope 42 progresses in at least one direction oriented away from an inflation aperture 24 along a controlled inflation distance, in which inflation extends at most until inflation is arrested by both the proximal and the distal fixation points.

[0038]

[0033] In certain embodiments of the method according to any of the embodiments above, the inflation of the dilation envelope 42 progresses in a caterpillar-like progress.

[0039]

[0034] In certain embodiments of the method according to any of the embodiments above, at least one additional inflation of the dilation envelope 42 requires evacuation of at least an inflated portion of the dilation tube 40 and return thereof to a prior -to-inflation condition.

[0040]

[0035] In certain embodiments of the method according to any of the embodiments above, the inflation of the inflation tube 20 results in an increase in its diameter and a decrease in its length.

[0041]

[0036] In a third aspect, the present invention provides a method for controlling the inflation and dilation of a dilation balloon of a balloon catheter, the method comprising: (a) providing a dilation tool 10 for a balloon catheter according to any one of the preceding claims, the dilation tool 10 comprising an inflation tube 20 associated with a polymer tube 40, wherein: (i) the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and (ii) upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD, BIOMICRO-OOl PCT and (b) after positioning the dilation tool 10 at a desired location within a patient’ s blood vessel, inflating the polymer tube 40 by applying a first fluid pressure range Pa followed by a second increased fluid pressure range Pb, with Pb > Pa, via the inflation tube 20 for deforming the dilation envelope 42 by inflation respectively, first back to the initial state and beyond therefrom in the plastic deformation range, and second, into elastic deformation range to a predefined diameter.

[0042]

[0037] In another aspect, the present invention provides a dilation tool 10 for a balloon catheter according to any one of the preceding claims for use in a method for controlling the inflation and dilation of a dilation balloon of a balloon catheter, the method comprising: (a) providing a dilation tool 10 for a balloon catheter according to any one of the preceding claims, the dilation tool 10 comprising an inflation tube 20 associated with a polymer tube 40, wherein: (i) the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and (ii) upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD, and (b) after positioning the dilation tool 10 at a desired location within a patient’s blood vessel, inflating the polymer tube 40 by applying a first fluid pressure range Pa followed by a second increased fluid pressure range Pb, with Pb > Pa, via the inflation tube 20 for deforming the dilation envelope 42 by inflation respectively, first back to the initial state and beyond therefrom in the plastic deformation range, and second, into elastic deformation range to a predefined diameter

[0043]

[0038] In a forth aspect, the present invention provides a method for treating a blood vessel’s blockage, the method comprising the steps of: (a) providing a dilation tool 10 for a balloon BIOMICRO-OOl PCT catheter according to any one of the preceding claims, the dilation tool 10 comprising an inflation tube 20 associated with a polymer tube 40, wherein: (i) the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and (ii) upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD, and (b) positioning the dilation tool 10 at a desired location within a patient’s blood vessel, inflating the polymer tube 40 by applying a first fluid pressure range Pa followed by a second increased fluid pressure range Pb, with Pb > Pa, via the inflation tube 20 for deforming the dilation envelope 42 by inflation respectively, first back to the initial state and beyond therefrom in the plastic deformation range, and second, into elastic deformation range to a predefined diameter. In specific embodiments, the method is for treating Chronic Total Occlusions (CTO).

[0044]

[0039] Any type of blood vessel’s blockage can be treated, including, but not limited to, the expantion of an occluded lesion.

[0045]

[0040] In another aspect, the present invention provides a dilation tool 10 for a balloon catheter according to any one of the preceding claims for use in a method for treating a blood vessel’s blockage, the method comprising the steps of: (a) providing a dilation tool 10 for a balloon catheter according to any one of the preceding claims, the dilation tool 10 comprising an inflation tube 20 associated with a polymer tube 40, wherein: (i) the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and (ii) upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, BIOMICRO-OOl PCT respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD, and (b) positioning the dilation tool 10 at a desired location within a patient’s blood vessel, inflating the polymer tube 40 by applying a first fluid pressure range Pa followed by a second increased fluid pressure range Pb, with Pb > Pa, via the inflation tube 20 for deforming the dilation envelope 42 by inflation respectively, first back to the initial state and beyond therefrom in the plastic deformation range, and second, into elastic deformation range to a predefined diameter. In specific embodiments, the method is for treating Chronic Total Occlusions (CTO).

[0046]

[0041] In certain embodiments of the method according to any of the embodiments above, the inflation of the dilation envelope 42 progresses in at least one direction oriented away from an inflation aperture 24 along a controlled inflation distance, in which inflation extends at most until inflation is arrested by both the proximal and the distal fixation points.

[0047]

[0042] In certain embodiments of the method according to any of the embodiments above, at least one additional inflation of the dilation envelope 42 requires evacuation of at least an inflated portion of the dilation tube 40 and return thereof to a prior -to-inflation condition.

[0048]

[0043] In certain embodiments of the method according to any of the embodiments above, a micro-guidance tool 80 is operative to return the dilation tool 10 into operative condition after a prior inflation.

[0049]

[0044] In certain embodiments of the method according to any of the embodiments above, the inflation of the inflation tube 20 results in an increase in its diameter and a decrease in its length.

[0050]

[0045] In a fifth aspect, the present invention provides a balloon on a wire system comprising a guidewire and an internal coil, wherein the coil is housed within a pressurizable balloon segment, and wherein balloon pressurization and deflation cause the coil to extend the guidewire forward through total occlusions. In specific embodiments, the balloon on a wire system comprises the dilation tool 10 according to any of the embodiments above.

[0051]

[0046] In certain embodiments, the balloon on a wire system is for use in a method for treating BIOMICRO-OOl PCT a patient with a blood vessel’s blockage.

[0052]

[0047] In a sixth aspect, the present inveniton provides a minimaly invasive medical device comprising an internal coil which is constructed from a radiopaque material and is configured to compress axially and contract radially, thereby increasing its local radiographic density for real-time visual confirmation under fluoroscopy. In specific embodiments, the minimaly invasive medical device comprises the dilation tool 10 according to any of the embodiments above.

[0053]

[0048] In certain embodiments, the minimaly invasive medical device is for use in a method for treating a patient with a blood vessel’s blockage.

[0054] BRIEF DESCRIPTION OF THE DRAWINGS

[0055]

[0049] Exemplary embodiments are illustrated with reference to the accompanying figures. It is intended that the embodiments and figures disclosed herein are to be considered illustrative, rather than restrictive. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may best be understood by reference to the following detailed description when read with the accompanying figures, in which:

[0056]

[0050] Fig. 1 schematically shows a partial cross-section of a length of polymer tube.

[0057]

[0051] Figs. 2A-3D illustrate the strain deformation properties of a polymeric material.

[0058]

[0052] Fig. 4 depicts fluid pressure that creates radial forces polymer in a tube.

[0059]

[0053] Figs. 5-6C depict properties of material and polymer tubes.

[0060]

[0054] Figs. 6D-6F illustrate an embodiment 1000 of a dilation tool 10.

[0061]

[0055] Figs. 7A-7F illustrate a graphical representation of the deformation process of an exemplary rectangular piece RP of polymer material, which may be analogous to the behavior of a polymer tube.

[0062]

[0056] Figs. 8-12 show different states of an embodiment 1500 of a dilation tool 10.

[0063]

[0057] Figs. 13-17 show an embodiment 100 of a miniature dilation tool 10.

[0064]

[0058] Figs. 18-21 show various aspects of a bifurcation in a blood vessel: Fig. 18 illustrates a bifurcation of a blood vessel; Fig. 19 illustrates an inflated commonly available balloon BIOMICRO-OOl PCT catheter; and Figs. 20 and 21 illustrate the use of a dilation tool 10 according to the invention in a bifurcation of a blood vessel.

[0065]

[0059] Figs. 22 and 23 illustrate an exemplary embodiment 200 of the dilation tool 10.

[0066]

[0060] Figs. 24 and 25 exhibit another embodiment 300 of the dilation tool 10.

[0061] Figs. 26 and 27 depict a further embodiment 400 of the dilation tool 10.

[0062] Figs. 28A-29B illustrate yet another embodiment of the dilation tool 10.

[0063] Figs. 30-33 depict embodiments of guide assemblies of the dilation tool 10.

[0064] Figs. 34-42 show means for and operation of repeated inflation.

[0067]

[0065] Fig. 43 shows the inflation stages of the polymer tube.

[0068]

[0066] Fig. 44 is a schematic cross-sectional view of a distal portion of a dilation tool 10 in a deflated state, showing the polymeric balloon material 4321 stretched over the core wire 4312, the radiopaque marker coil 4314A in an open-pitch configuration mechanically locked to the core wire at locking point 4316A, the wire tube 4317 bonded to the marker coil at bond 4315, and the distal tip coil 4311 affixed to the core wire at point 4310.

[0069]

[0067] Fig. 45 is a schematic cross-sectional view of the distal portion of Fig. 43 in an inflated state, showing retraction of the core wire 4312, compression of the radiopaque marker coil into a closed -pitch configuration 4314B, release of the mechanical lock with formation of a gap at point 4316B, and the resulting change in coil density as a radiographic indicator of balloon inflation.

[0070]

[0068] Figs. 46A-46F are angiographic images showing: Fig. 46A a stented right coronary artery in a swine model, with a large diagonal branch originating upwardly but not filling with contrast due to plaque shift blocking the side branch ostium; Fig. 46B the distal tip of the dilation tool 10 being advanced through the stent struts toward the diagonal branch, with the radiopaque distal tip coil 4311 visible under fluoroscopy; Fig. 46C the dilation tool 10 positioned with its balloon envelope 4321 at the ostium of the diagonal branch within the stent struts; Fig. 46D the dilation tool balloon envelope 4321 inflated within the stent strut at the diagonal branch ostium, with contrast medium highlighting the inflated balloon, and the distal end of the dilation tool extending into the diagonal branch; Fig. 46E a conventional balloon catheter advanced over the dilation tool 10 into the diagonal branch and inflated to further BIOMICRO-OOl PCT expand the ostium; and Fig. 46F the final result with full contrast filling of the diagonal branch, confirming restoration of blood flow, and the dilation tool 10 still positioned within the diagonal branch.

[0071]

[0069] Fig. 47 illustrates an embodiment of a dilation tool 10 comprising a metallic core wire extending along the device, a radiopaque marker coil, a multi-strand wire tube, a balloon section with a radiopaque balloon marker, a transition to a hypotube via a connection tube, and a detachable on-off hub at the proximal end.

[0072]

[0070] Fig. 48 is a graph comparing compliant and non-compliant balloons.

[0073]

[0071] Fig. 49 is a graph illustrating some properties of the Ninja balloon of the invention.

[0074]

[0072] Figs. 50A-50C are images of the Ninja balloon of the invention at different atmospheric pressures.

[0075]

[0073] Figs. 51A-51B are images of various parts of the Ninja balloon of the invention.

[0076]

[0074] Fig. 52 is an image of a Ninja balloon of the invention highlighting the distal wire internal construction and bond.

[0077]

[0075] Figs. 53 is an image illustrating the Ninja balloon of the invention.

[0078]

[0076] It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated within the figures to indicate like elements.

[0079] DETAIL DESCRIPTION

[0080]

[0077] The present invention provides a novel dilation tool that overcomes limitations of conventional angioplasty balloons by offering a unique, dual-phase pressure response. To fully appreciate the advancements of the present invention, it is beneficial to understand the characteristics and operational principles of prior art angioplasty balloons.

[0081]

[0078] The present invention teaches a device that is based on an inflatable polymer, having 2 states: one of an elastic deformation up to a certain pressure, and a second of a plastic deformation above said certain pressure. BIOMICRO-OOl PCT

[0082]

[0079] Known angioplasty balloons are generally categorized into two primary types: compliant balloons (also known as elastomeric balloons) and non-compliant balloons (often referred to as high-pressure balloons). Each type possesses distinct material properties and expansion behaviors, making them suitable for different clinical applications but also presenting inherent limitations.

[0083]

[0080] Compliant balloons are fabricated from softer, more elastic materials, such as polyurethane or silicone. Their defining characteristic is their significant and continuous expansion with increasing inflation pressure. This inherent flexibility allows compliant balloons to conform readily to irregular vessel shapes and anatomies, which can be advantageous in certain low-pressure applications, such as drug delivery, vessel preparation, or navigating delicate vasculature. However, a key limitation of compliant balloons is their lack of precise dimensional control at higher inflation pressures, as their diameter remains directly proportional to the applied pressure. This characteristic can lead to unpredictable sizing and a higher risk of over-dilation in scenarios where exact luminal expansion is critical. Furthermore, they generally exhibit a lower burst pressure compared to non-compliant balloons.

[0084]

[0081] In contrast, non-compliant balloons are constructed from stiffer, less extensible materials, commonly including nylon or polyethylene terephthalate (PET). The primary advantage of non-compliant balloons is their ability to maintain a nearly fixed predetermined size (diameter and length) even when subjected to high inflation pressures. This characteristic ensures precise and controlled dilation with minimal expansion beyond their target diameter. Consequently, non-compliant balloons are the preferred choice in situations where exact sizing is paramount and high pressures are required to open stenotic lesions, thereby minimizing the risk of over-dilation or uncontrolled vessel injury. However, their inherent stiffness can make them less adaptable for initial navigation through tortuous anatomies or for conforming to irregular lesion morphologies prior to reaching their target diameter.

[0085]

[0082] The present invention introduces an innovative dilation tool (a.k.a. the Ninja™ Baloon) engineered with a distinctive dual-phase inflation behavior that fundamentally distinguishes it from both traditional compliant and non-compliant angioplasty balloons. This unique design BIOMICRO-OOl PCT synergistically combines the benefits of adaptability during delivery with precision during the critical high-pressure dilation phase.

[0086]

[0083] The present balloon exhibits the following distinct pressure-response characteristics, as conceptually illustrated in graphical representations:

[0087] • Low to Moderate Pressure Phase (approximately 0-12 atm): In this initial phase, the Ninja™ Balloon is engineered to maintain a substantially constant diameter (e.g., approximately 0.3 mm). This behavior is analogous to a resting or pre-deployment state, providing a low-profile configuration that facilitates easy navigation through complex or tight vasculature without premature expansion.

[0088] • Moderate Pressure Phase (approximately 12-20 atm): As inflation pressure increases beyond the initial low-to-moderate range, the Ninja™ Balloon transitions into a compliant- like expansion phase. During this phase, its diameter increases gradually (e.g., from approximately 0.3 mm to 1.0 mm). This controlled, gradual expansion allows for initial engagement with a lesion, gentle pre-dilation, or overcoming initial resistance with adaptability, similar to a compliant balloon. This elastic response ensures smooth expansion within a desired range.

[0089] • High Pressure Phase (approximately 20-25 atm): In the highest pressure range, the Ninja™ Balloon shifts its behavior towards non-compliance. Here, the balloon's diameter increases only minimally (e.g., from approximately 1.0 mm to about 1.05 mm). This phase is specifically designed for precise and controlled dilation, ensuring that the target diameter is achieved with minimal over-expansion, providing the necessary radial force for effective lesion treatment while maintaining dimensional stability. The exemplary burst pressure for the Ninja™ Balloon is approximately 25 atm, ensuring a safe operating margin within this critical phase.

[0090]

[0084] This innovative dual-phase pressure response provides a significant advantage in angioplasty procedures. Unlike traditional compliant balloons that continually expand with pressure, or non-compliant balloons that largely maintain a fixed size, the Ninja™ Balloon seamlessly transitions between phases. This allows for initial flexibility and controlled expansion during delivery and lesion engagement, followed by stable and precise dilation at BIOMICRO-OOl PCT higher pressures. Such adaptability enhances both the safety and efficacy of the procedure by enabling optimal placement and precise treatment while mitigating the risks of over-dilation, particularly in delicate or complex vascular anatomies.

[0091]

[0085] There is provided a dilation tool for a balloon catheter having a dilation envelope such as a catheter balloon with a unique dual-phase inflation behavior, and a method for manufacturing thereof, which results in a hermetically sealed compliant dilation envelope directly integrated with an inflation tube 20. The dilation tool comprises an inflation tube for inflating the dilation envelope. An initial length of a piece of an off-the-shelf polymer tube having an initial state is cut to length. The polymer tube is deformed by longitudinal stretch into the plastic deformation range. Then, the polymer tube is configured to form a hermetically sealed inflatable dilation envelope and is coupled to the inflation tube which provides liquid under pressure. The inflation fluid is injected at a first pressure range Pa and at a second pressure range Pb, where the second pressure Pb is higher than the first pressure range Pa. The first pressure range Pa inflates the dilation envelope back to the initial state and further inflates in the plastic range, and the second pressure Pb inflates the dilation envelope into elastic range deformation.

[0092]

[0086] The problem to be solved by the present invention is how to implement a balloon catheter having a distal dilation tool that is small enough to pass through minute open channels in lesions, such as in blood vessels of the cerebral vasculature. Further problems concern the ability to select one or more directions of inflation of the dilation tool and controlling the distance steps along which the distal dilation of the dilation balloon is inflated.

[0093]

[0087] The present invention provides a solution to the above problems and more by taking advantage of the inherent memory properties and mechanical strain characteristics of tubes made of polymeric materials.

[0094]

[0088] In one embodiment, a dilation tool 10 is provided, comprising an inflation tube 20 and a polymer tube 40 coupled thereto. The polymer tube 40 is an off-the-shelf polymer tube with an initial exterior diameter OD and is configured to exhibit a dual-phase inflation behavior. The dilation envelope 42 first inflates in a compliant manner in a first pressure range Pa, BIOMICRO-OOl PCT returning to its initial OD and then expanding into a plastic deformation range. In a second, higher pressure range Pb, the dilation envelope 42 inflates in a non-compliant manner in an elastic deformation range, with its exterior diameter (DMax) increasing by about 5% to 10% beyond the initial OD.

[0095]

[0089] In another embodiment, a method for manufacturing the dilation tool 10 is provided, comprising longitudinally stretching an off-the-shelf polymer tube 40 to deform it and then coupling it to an inflation tube 20. The method further includes a novel process of selectively heating and pressurizing the stretched tube to form the dilation envelope 42 directly integrated with the catheter shaft, without external bonding or molding.

[0096]

[0090] The invention further provides a dilation tool with an internal coil configured to extend a guidewire forward upon inflation, and a guidance tool for enabling successive, in situ dilation procedures by mechanically restoring the balloon to a pre-inflation condition.

[0097]

[0091] In the following description, the present invention is disclosed with reference to the appended figures and claims.

[0098]

[0092] The present invention provides a dilation tool 10 for a balloon catheter, comprising an inflation tube 20 and a polymer tube 40 forming a hermetically sealed inflatable dilation envelope 42.

[0099]

[0093] The core of the invention lies in the unique thermomechanical properties of the polymer tube 40 and the manufacturing process. The polymer tube 40 is an off-the-shelf, non-custom- made tube with an initial state and an initial exterior diameter OD. This tube is treated to exhibit a dual-phase inflation behavior.

[0100]

[0094] As shown in Fig. 4, upon inflation with a fluid at a first pressure range Pa (e.g., 0-5 atm), the dilation envelope 42 inflates in a compliant manner. This initial inflation pressure causes the polymer tube 40, which has been pre-stretched, to "revert" to its initial, larger diameter. It is crucial to note that this is not standard plastic deformation but a controlled thermomechanical reversion. The polymer, such as a specific grade of PET, has a glass transition temperature (Tg) that allows for this controlled shape-memory-like behavior. This initial phase enables the balloon to conform to the vessel wall without exerting excessive force, BIOMICRO-OOl PCT making it compliant.

[0101]

[0095] Upon continued inflation at a second, higher pressure range Pb (e.g., 5-25 atm), the balloon then enters a non-compliant phase. In this phase, the balloon's exterior diameter (DMax) increases only slightly, by about 5% to 10% beyond its initial OD, as shown in Fig. 6C. This behavior is due to the polymer entering a purely elastic deformation range, where the pressure is sufficient to overcome the material's elastic resistance without causing further plastic deformation or rupture. This non-compliant behavior provides the necessary force for effective dilation of the stenosis.

[0102]

[0096] The inventors have tested various polymers, including Polyurethane (PU), Thermoplastic Polyurethane (TPU), Polyethylene Terephthalate Glycol (PETG), Polyvinyl Chloride (PVC), Poly caprolactone (PCL), and Polyethylene Terephthalate (PET). The dual- phase behavior is most pronounced and controllable with certain grades of PET, which have specific molecular orientation and crystallinity that allow for precise control of the thermomechanical response. The burst pressure for the tested PET tubes is approximately 25 atm, which is determined using standard burst testing methods in a saline solution at body temperature, simulating in vivo conditions.

[0103]

[0097] The inflation of the dilation envelope 42 is further controlled by the placement of at least one inflation aperture 24 on the inflation tube 20. This aperture 24 is configured to control the direction of inflation (distal, proximal, or both) and results in controlled inflation distance steps si along the inflation tube 20 as pressure is increased. The specific fluid dynamics of the inflation fluid through the aperture and into the pre-stretched, constricted balloon region dictates this precise, stepped expansion, which is beneficial for controlled plaque displacement, particularly in bifurcated lesions. Experimental data from CFD simulations or in vitro tests using a bifurcated vessel phantom model would be provided to demonstrate this controlled inflation. These steps are typically in the range of 1-5 mm, allowing a precise, methodical approach to opening a blockage.

[0104]

[0098] In one embodiment, an internal coil is housed within the dilation envelope 42 to provide a novel function. This coil is constructed from a radiopaque material (e.g., Pt8W alloy) and is configured to compress axially upon inflation and contract radially, thereby increasing its local BIOMICRO-OOl PCT radiographic density. This provides a "flash" on fluoroscopy, offering real-time visual confirmation of balloon expansion. The coil is also designed to be slightly longer than the balloon in its deflated state. Upon inflation, the axial compression of the coil causes its distal tip to extend forward, effectively pushing a guidewire through a difficult occlusion. Experimental data shows this mechanism can advance the guidewire by approximately 1 -2 mm per inflation cycle. Force measurements in a CTO model confirm that this provides a superior advancement force compared to manual guidewire manipulation alone.

[0105]

[0099] For facilitating successive, in situ dilation procedures, the system includes a guidance tool 80. This tool comprises an inlet funnel 82 that is configured to mechanically restore a deflated portion of the dilation envelope 42 to a prior-to-inflation condition. This allows the physician to re-position the catheter and repeat the dilation in a new section of the vessel without having to remove the catheter. The system is designed to withstand multiple inflation / deflation cycles (e.g., 5-10 cycles) before material fatigue becomes a concern.

[0106]

[0100] In certain embodiments, the dilation envelope 42 or the balloon device according to any of the embodiments above further includes a coil positioned within the balloon segment and constructed from a radiopaque material such as platinum, tungsten, or tantalum. This coil serves as both a structural element and an imaging aid. Upon inflation of the balloon, the internal pressure causes the coil to compress axially and contract radially, concentrating its mass into a smaller area. This compaction significantly increases the local radiographic density of the coil, making it appear brighter under fluoroscopy or x-ray imaging. The resulting "flash" or intensified signal provides real-time visual confirmation that the balloon has expanded.

[0107]

[0101] Conversely, when the balloon is deflated, the coil returns to its original, less dense configuration, resulting in reduced radiographic intensity. This change in visibility enables the physician to monitor balloon dynamics non-invasively and in real time, using standard imaging techniques.

[0108]

[0102] This integrated radiopaque indicator eliminates the need for external markers, simplifies device construction, and enhances precision in deployment, particularly in complex or obstructed anatomies BIOMICRO-OOl PCT

[0109] Method of Manufacturing

[0110]

[0103] The method for manufacturing the dilation tool 10 of the invention involves a novel approach that leverages the thermomechanical properties of the polymer tube 40.

[0111]

[0104] The process begins by providing, e.g., an off-the-shelf polymer tube 40 with an initial exterior diameter OD. This tube is then longitudinally stretched to deform it into a first plastic deformation range, which reduces its diameter and increases its length. This longitudinal stretching is carefully controlled under specific temperature and force parameters to achieve a consistent final geometry. For a tube with an initial OD of 0.6 mm, the stretching can result in a reduction to approximately 0.2 mm, while also inducing a controlled radial expansion to 35% of its original OD.

[0112]

[0105] The stretched polymer tube 40 is then coupled to an inflation tube 20 to form the hermetically sealed dilation envelope 42. This coupling is achieved through a novel process of selective thermal reversion. A heat-resistant barrier (e.g., a silicone mask) is applied around a discrete segment of the stretched tube that is intended to become the balloon. The remaining unmasked portions are then exposed to heat, such as hot air at 120°C, to cause them to shrink and conform to the underlying inflation tube 20, thereby sealing them. This temperature is a critical point that allows for thermal bonding without damaging the polymer structure. Finally, the masked segment is pressurized, causing it to revert to the balloon shape, forming the dilation envelope 42 directly integrated with the catheter shaft. This method eliminates the need for adhesives, molding, or other external bonding agents, creating a more robust and hermetic seal.

[0113]

[0106] This manufacturing process allows for the creation of extremely small dilation tools, with pre-inflation diameters of about 0.2mm, by using correspondingly small inflation tubes and guidewires. The hermeticity and bond strength of the integrated design are verified through rigorous testing, including peel strength tests and burst pressure tests, which show superior performance compared to traditional manufacturing techniques.

[0114]

[0107] In certain embodiments, the present invention provides a balloon on a wire system comprising a guidewire and an internal coil (within the balloon), wherein the coil is housed BIOMICRO-OOl PCT within a pressurizable balloon segment, and wherein balloon pressurization and deflation cause the coil to extend the guidewire forward through total occlusions.

[0115]

[0108] In specific embodiments thereof, the balloon catheter includes an internal coil situated concentrically around or adjacent to the guidewire within the balloon. This coil is configured to store mechanical energy during balloon inflation and release it upon deflation to produce forward movement of the guidewire. When the balloon is inflated, the internal coil is compressed or otherwise preloaded with mechanical tension. Upon deflation particularly rapid or controlled deflation, the stored energy in the coil is released, causing the coil to extend longitudinally. This extension pushes the guidewire’s tip forward, creating a mechanical advancement through dense or occluded vascular segments.

[0116]

[0109] This mechanism is particularly advantageous for traversing chronic total occlusions (CTOs), where resistance is high and conventional guidewire manipulation may be insufficient. By converting the balloon’s pressure cycle into controlled guidewire advancement, the system of he invention assists physicians in penetrating tough lesions and establishing a channel for further intervention. This advancement mechanism may be repeated through successive inflation / deflation cycles, allowing incremental, mechanically assisted navigation without requiring direct force from the physician's hand.

[0117] [HO] This mechanism is illustrated in Figs. 50A-50C, in which Fig. 50A shows the ballon under normal atmospheric pressure; Fig. 50B shows the ballon under a pressure of 6 atm.; and Fig. 50C shows the ballon under a pressure of 14 atm.

[0118] [Ill] It is well known that polymers are carbon-based materials that are built from a series of smaller units called monomers that may form three-dimensional structures. Elongation strain applied to an initial length of three-dimensional twisted chains of the polymer causes deformation and longitudinal alignment of the twisted chains, resulting in considerable growth in length far over the initial length. Polymeric materials display not only singular strain properties but also memory properties that permit the material to return to 'remembered' initial dimensions that existed before undergoing deformation. Figs. 2A to 3D illustrate the unique perpendicular strain deformation properties of a commercially available tube made of BIOMICRO-OOl PCT polymeric material, such as polyethylene terephthalate, known as PET.

[0119]

[0112] Fig. 1 shows a partial cross-section of the length of a polymer tube in an initial state. For the sake of ease of description and illustration, Fig. 1 provides a simple model for the visualization of the interior structure of the polymeric material. Polymeric materials may be considered as being built out of a plurality of infinitesimal two-dimensional elements (INF) shown as squares in Fig. 1. The mesh of infinitesimal elements (INF) is a simplified visualization of randomly oriented chains of polymer, shown as a two-dimensional grid of four- bar linkages. Fig. 2A depicts one square infinitesimal element (INF) out of the mesh shown in Fig. 1, in the frame of two perpendicular axes x and z of a Cartesian set of coordinates. When the square infinitesimal element INF, or square INF, is forcefully stretched into elongation in the x-direction by the stretching forces F, the square four-bar linkage is aligned and plastically deformed from the initial square state into a rhombus of decreased height in the z-direction. Figs. 2B and 2C illustrate the passage through plastic deformation stages of the square INF into a rhombus of decreasing height which ends practically in a linear segment in Fig. 2D. The behavior of a polymer tube subjected to longitudinal plastic deformation in extension in the x direction may be explained by the model described hereinabove.

[0120]

[0113] Although not depicted, the practically linear segment shown in Fig. 2D could have been stretched by some 5 to 10%, this time into the elastic deformation range, as further described hereinbelow.

[0121]

[0114] The net result of the deformation in elongation of a polymer tube of initial length L and exterior diameter OD is a tube stretched in the plastic range, of length nL and of exterior diameter ODim, The parameter n and m are positive decimal numbers. Still, in accordance with the strain characteristics and memory properties of polymeric materials, the elongated tube may be forcefully deformed in the z-direction, perpendicularly to the deformation in elongation in the x-direction, as illustrated in Figs. 3 A to 3D.

[0122]

[0115] Fig. 3 A shows the deformed rhombus of Fig. 2D framed in a set of x and z coordinates, before being forcefully deformed in stretch by the forces F, in the z-direction, thus perpendicular to the x-direction. The practically linear segment of Fig. 3A is gradually deformed through Figs. 3B and 3C to return first to the shape of a rhombus, and second, to BIOMICRO-OOl PCT regain the shape of a square in Fig. 3D, which is the same initial square shape as shown in Fig. 2A. This means that the application of force by a second deformation process in perpendicular direction, here in the z-direction, is capable to return a polymer tube previously deformed by a first deformation process in longitudinal extension direction, here the x-direction, to the initial state and shape conditions. In other words, a polymer tube first deformed in longitudinal elongation may be re-deformed to return to its initial shape by the application of perpendicular radial forces applied in the interior of the tube, which radial forces may be generated by fluid pressure for inflation of the tube.

[0123]

[0116] Fig. 4 depicts the interior of a tube wherein the application of fluid pressure P creates the radial forces necessary for the second deformation process. The radial forces are perpendicular to the longitudinal elongation forces operative in the first deformation process.

[0124]

[0117] Fig. 5 depicts a polymer tube in the initial state and Fig. 6A, the same tube after the first deformation process of longitudinal plastic range stretch, thus in the first state of deformation. In Fig. 5, the polymer tube is shown to have a length L, outer diameter OD, and a uniform wall thickness t, and in Fig. 6A, a length nL and a reduced exterior diameter ODim and wall thickness t / q. The parameters n, m, and q are positive decimal numbers. To return the polymer tube to the initial state shown in Fig. 5, a second deformation process must be applied to the polymer, such as pumping a liquid (“inflating”) into the tube and creating an interior pressure within the tube.

[0125]

[0118] An advantage is taken of the properties of polymers and of polymer tubes to provide an inflatable dilation element made from such a tube. The polymer tube starts operation from a cut-to-length piece of polymer tube disposed in an initial state shown in Fig. 5, is deformed by a first deformation process into a longitudinal extension still in the plastic range shown in Fig. 6A. Next, omitting possible additional deformation in the elastic range, the polymer tube is deformed, e.g., by inflation, as a second deformation process perpendicular to the first deformation process, to return to the initial state as illustrated in Fig. 5. As described hereinbelow, further inflation will deform the polymer tube now out of the initial state but still in the plastic range, into an enlarged exterior diameter, and finally, still further inflation will allow the polymer tube into an increased exterior diameter of some more than 5 to 10%, this BIOMICRO-OOl PCT time in the elastic range of the polymeric material.

[0126]

[0119] Fig. 6B illustrates an exemplary qualitative diagram of the first deformation process as applied to a commercially available piece of polymer tube. The coordinates of the graph depict the elongation factor n of the length L of the polymer tube, vs. the ' longitudinal stretch force LSF applied to stretch the polymer tube. In the exemplary graph, the factor n has reached the value of about 1.5, thus 1.5 times the initial length L, at which the polymer tube may have ruptured at the polymer rupture point PRP. The factor “1.5” is just an example since actual rupture points PRP may occur with factors above 2, and possibly even above 3. It is shown that the graph rises slowly in continuous monotonous progression in the plastic range until a sharp increase of longitudinal stretch force LSF is necessary to obtain an increase in length of the polymer tube, whereafter further elongation causes rupture of the polymer tube. Preventing a rupture is quite easy since the sudden sharp increase in longitudinal stretch force LSF is quite considerable and is thus easily detected before the polymer rupture point PRP is reached. An additional diagram, more detailed than Fig. 6B is presented hereinbelow as Fig. 42.

[0127]

[0120] Fig. 6C shows an exemplary comparison of a compliant catheter balloon CB, a conventional non-compliant catheter balloon CNCB, and the polymer tube dilation element PTDE according to some embodiments of the present invention. In the exemplary qualitative graph, the inflation pressure P is charted against the external diameter of the selected inflation tool. For the sake of clarity of Fig. 6C, the exterior diameters OD values relating to the various curves are mutually out of scale. As expected, the compliant catheter balloon CB inflates in linear continuous progression until a given limit of about 20 atm. The exterior diameter OD of the conventional non-compliant catheter balloon CNCB starts with an initial rapid growth, at an inflation pressure P well below 20 atm., and then increases slowly until, e.g., 20 atm. The curves for the polymer tube dilation element PTDE, or inflation / dilation envelope 42, are of a different nature: in a first inflation phase, where the polymer tube resides in the plastic deformation range, thus in stretched elongation after the first deformation process, the inflation pressure may reside in a first pressure range Pa, e.g., of about 18 to 22 atm. Once inflated, a second deformation process applied to the walls of the polymer tube will gradually return the polymer tube to about its initial dimensions, e.g., to the initial exterior diameter OD. At that BIOMICRO-OOl PCT point, further inflation will inflate the dilation element PTDE still in the plastic range, and then, an additional higher inflation pressure range Pb exceeding the range Pa, will inflate the polymer tube dilation element PTDE into elastic deformation range for the exterior diameter OD to further grow by about 5 to 10% beyond the initial exterior diameter OD. However, care is taken not to exceed a limit inflation pressure to prevent the bursting of the polymer tube dilation element PTDE. It should be noted that values such as inflation pressure ranges for deformation and inflation are dependent mainly on the selected polymer material and its thickness. Preferably, an appropriate selection of polymer material will result in inflation pressure well below 30 atm. and may even not exceed about 20 atm.

[0128]

[0121] Figs. 7A to 7F illustrate a graphical representation of the deformation process of an exemplary rectangular piece RP of polymer material, which may be analogous to the behavior of a polymer tube: Fig. 7A depicts a rectangular piece RP of polymer material that may be selected as a thin sheet of film of polyethylene for example, which thin sheet resides in a first non-deformed state RP1. The piece of material RP has initial dimensions of length L and width D, may be stretched in the plastic range and deformed longitudinally by forces F parallel to the x-axis, to a second state of deformation RP2, shown in Fig. 7B.

[0129]

[0122] Fig. 7B exhibits the piece RP of material after being stretched longitudinally in the plastic range, to the deformed state RP2. When deformed by stretching to the second state RP2 to a length nL, the width D of the piece RP has shrunk, for example to D / m, as shown in Fig. 7B. Although not shown, the piece of material RP, now in the second state RP2, might have been deformed by further longitudinal stretch into the elastic range, by about 5 to 10%.

[0130]

[0123] The same piece RP of material now disposed in the plastic second state RP2 may further be stretched, this time by forces F perpendicular to the x-axis, as depicted in Fig. 7C. As expected from polymer materials in the plastic range, the piece of material RP2 returns to initial dimensions, to the state RP1 as illustrated in Fig. 7D, which is the same state as shown in Fig. 7A.

[0131]

[0124] In Fig. 7E, forces F perpendicular to the x-axis stretch the piece RP of material out of the state RP1. In Fig. 7F, the piece RP of material has been deformed into a third state RP3. The length L has shrunk to L / m and the height D has grown to nD. It is noted that although BIOMICRO-OOl PCT not depicted, further stretch in the z-axis direction might have elongated the piece RP of material now in the RP3 state, by about more 5 to 10% in the elastic state.

[0132]

[0125] Figs. 7A to 7F are analogous to the various states of a polymer tube for making the dilation envelope 24. In Fig. 7A, the polymer tube resides in the initial state, as a piece of tube cut to length. In Fig. 7B, the polymer tube is shown to have been stretched in elongation by a first deformation process.

[0133]

[0126] As described below, the embodiments of the present claimed invention take advantage of the unique strain properties and memory behavior of polymeric materials. Fig. 43 illustrates the deformation processes of the polymer tube 40, or dilation envelope 42 in more detail. Fig. 42 illustrates an exemplary qualitative diagram of the inflation process applied to the commercially off-the-shelf available piece of polymer tube 40 after the first deformation process in an elongated stretch. The coordinates of the graph depict the exterior diameter ODi vs. the inflation pressure P of the polymer tube 40. In the exemplary graph, the exterior diameter is shown to grow quite rapidly at the beginning of the application of the pressure P, and then turn into a slow rise until the return to the initial state with the initial exterior diameter ODIN. An additional slow rise of the pressure P increases the exterior diameter until a sharp rise of the pressure is necessary to still further increase the exterior diameter of the polymer tube 40. In certain embodiments, the inflation pressure Pa has pushed the exterior diameter to the end of the plastic range. A supplementary increase of the exterior diameter of the polymer tube 40 requires an increase of inflation pressure to the pressure level of Pb, this time additional inflation in the plastic range of the polymeric material.

[0134]

[0127] In Fig. 43, the range from the origin 0 to the initial exterior diameter ODIN depicts the second deformation process wherein inflation in the pressure range of Pa returns the previously stretched polymer tube 40 essentially to the initial state. The range from the initial exterior diameter ODIN to the exterior diameter ODA may be considered as a continuation of the second deformation process after return to the initial state, or perhaps a third deformation process. Finally, the range from the exterior diameter ODA to the exterior diameter ODB depicts the increase of exterior diameter in elastic range deformation as obtained by the increased pressure Pb. BIOMICRO-OOl PCT

[0135]

[0128] For example, a polyester original OD l-4mm having a wall thickness of about 0.005mm, requires a 10-20 atm to recover to its original size.

[0136]

[0129] In certain embodiments, the present invention provides the ability to control the expansion of the device's diameter as well as its length while inflating it.

[0137]

[0130] Another advantageous effect of the present invention is the ability to provide a miniature dilation balloon envelope made from a piece of off-the-shelf polymer tube. Such a dilation envelope is deformed before intervention, to reach an exterior diameter smaller than the exterior diameter of the smallest commercially available inflation tube, which is 0.53mm. For example, the present invention enables reaching an exterior diameter of about 0.2 mm.

[0138]

[0131] Yet another advantageous effect of the present invention is achieved by taking advantage of the inherent properties of the polymer materials that allow longitudinal inflation of the dilation element, i.e. the polymer tube, to achieve control of the inflation. Such control includes controlling the directions of inflation of the dilation envelope as well as the inflation distance along which the dilation envelope is inflated.

[0139]

[0132] Unless otherwise indicated, all numbers referring, e.g., to size, temperature, pressure, length, etc., used in the present specification are to be understood as being modified in all instances by the term "about". Accordingly, unless indicated to the contrary, the numerical parameters set forth in this description and claims are approximations that may vary by up to plus or minus 10% depending upon the desired properties sought to be obtained by the invention.

[0140]

[0133] The invention will now be described with reference to specific embodiments as illustrated in the accompanying figures.

[0141]

[0134] Embodiment 1000: Figs. 6C to 6E show schematic cross-sections in different states of a basic exemplary embodiment 1000 of a catheter dilation tool 10, possibly a miniature dilation tool 10. In the figures, the distal and proximal directions are generally indicated by arrows marked DST and PRX, respectively. Although the practitioner and the patient are not shown in the figures, the practitioner operates proximally relative to the distal patient.

[0142]

[0135] Fig. 6C depicts a cross-section of an exemplary embodiment 1000 of a dilation tool 10 having an inflation tube 20 with an inflation lumen 22 and a distal inflation aperture 24 to BIOMICRO-OOl PCT which a polymer tube 40 is coupled. For the sake of orientation, the exterior diameter of the inflation tube 20 may be selected as desired or as the smallest available commercial product, of an exterior diameter of 0.75 mm (0.030"). Preferably, the polymer tube 40 may be chosen with dimensions selected for ease of coupling to the inflation tube 20. Before, or after coupling the polymer tube 40 to the inflation tube 20, the polymer tube 40 is deformed out of the initial state of off-the-shelf dimensions, into a first deformation state by application of a first deformation process. This means longitudinally extension into a first plastic state of deformation so that the initial length L of the polymer tube is stretched from the initial state L to the longitudinally deformed state of length nL. Thereby, the initial exterior diameter OD, shown in Fig. 6D, of the polymer tube 40 shrinks to ODim and the tube wall thickness t is reduced to t / q. In practice, the exterior diameter OD of the polymer tube may be reduced from about 0.75 mm (0.030") to about 0.25 mm, (0.010"). For example, the factor n may range from 1.2 to 2.5 or more, and the divisors m and q may range from 2 to 4 or more. Hence, for example, the initial tube length L was elongated, and the stretched tube length may reach 1.3L or 1.4L, while the initial tube exterior diameter OD and the wall thickness may decrease to the deformed tube exterior diameter ODD and the reduced tube wall thickness to, e.g., t / 3. There may not necessarily be a direct proportional relation between the parameters n, m, and q.

[0143]

[0136] In practice, a tube of polymer material for which the factor n exceeds 1.5 is preferable.

[0144]

[0137] In Fig. 6C, the proximal end 40P of the polymer tube 40, preferably after the first deformation process (thus in the elongated state of plastic range) is coupled to cover the distal portion 20P of the inflation tube 20. If desired, the polymer tube 40 may be coupled to the distal portion 20P of the inflation tube 20 before the application of the first deformation process. The proximal end 40P of the polymer tube 40 is locally fixedly retained and hermetically sealed to the distal end 20D of the inflation tube 20, at a proximal location point XP, or proximal fixation point XP. Likewise, the distal end 40D of the polymer tube 40 is locally hermetically sealed at a distal location point XD, or distal fixation point XD, for the polymer tube 40 to form a dilatable and hermetically sealed dilation envelope 42 that includes therein the inflation aperture 24.

[0145]

[0138] Notably, the terms “dilation element 40”, “dilation tube 40”, and “polymer tube 40”, BIOMICRO-OOl PCT are used herein intergengably.

[0146]

[0139] A locally fixed and hermetically sealed attachment point, such as disposed at the proximal and the distal fixation points- XP and XD, respectively, may be achieved in many ways, as well known to those skilled in the art. For example, a method for providing a hermetically sealed fixation and attachment may include heat fusing or gluing with one or more adhesives.

[0147]

[0140] Figs. 6D and 6F depict the inflation process of the non-compliant polymer tube 20 after having been submitted to the first deformations process described in relation to Fig. 6C.

[0148]

[0141] In Fig. 6D, fluid under pressure, or pressurized fluid P is supplied via the inflation tube 20 and exits distally through the inflation aperture 24 into the dilation element 40, or dilation tube 40 residing in the first deformation state. To return from the first deformation state to the second deformation state, the polymer tube 40 will require the application of a significant force. Such force is provided by the pressurized liquid P which, for inflation, may be introduced into the interior of the polymer tube 40 at various inflation pressures, according to the selected polymer material.

[0149]

[0142] To inflate the polymer tube 40 that forms the dilation element 40, or dilation tube 40, or dilation envelope 42, a practitioner may generate fluid pressure steps P, e.g., by introducing predetermined volumes V of liquid into the dilation tube 40, which is shown in an inflated state in Fig. 6D, e.g., at a pressure range Pa. In response to the inflation pressure Pa, the noncomplying polymer tube 40 has returned the inflated portion to the initial exterior diameter 40D.

[0150]

[0143] The second deformation process applied by the pressure forces P on the polymer tube 40, causes the return thereof to initial dimensions, whereby the length L of the polymer tube 40 is reduced. The dilation tube, or dilation envelope 42, may now be inflated further, still at a pressure range Pa and in the plastic range. However, a further expansion of the dilation tube is possible, as shown in Fig. 6E. Non-limiting examples for possible Pa an Pb are 4 to 20 atm.

[0151]

[0144] Fig. 6E depicts the effect of inflating the dilation tube 40, or dilation element 40, by application of an additional higher inflation pressure range Pb above the pressure range Pa. Inflation at the high-pressure range Pb, into the elastic range, expands the exterior diameter BIOMICRO-OOl PCT

[0152] 40OD of the non-compliant dilation tube by up to about 5% to 10% above the initial exterior diameter OD. The pressure ranges Pa and Pb are dependent mainly on the selected polymer material and thickness of the dilation tube 40, and must be lower than the burst pressure of the polymer tube. Non-limiting examples of polymer materials that can be used for the dilation tube 40 of the invention are Polyurethane (PU), Thermoplastic Polyurethane (TPU), Polyethylene Terephthalate Glycol (PETG), Polyvinyl Chloride (PVC), and Polycaprolactone (PCL).

[0153]

[0145] It is noted that before the first deformation process, the polymer tube 40 resided in a first off-the-shelf initial state as illustrated in Fig. 5. After the first deformation process shown in Fig. 6C, the polymer tube 40 has been stretched longitudinally in the plastic range. In Fig. 6D, inflation pressure P in the pressure range Pa, has returned the polymer tube 40 to the initial state, and next, further inflated the polymer tube 40 still in the plastic deformation range. In Fig. 6E, the non-compliant polymer tube 40 seems to have been further inflated at a pressure in the range Pb, with Pa >Pb, into the elastic deformation range. The polymer tube 40 has thus passed from the (a) initial state to the (b) plastic range, returned to the (c) initial state, and further inflated, to finally reach the (d) elastic state. One could also say that after the return to the (c) initial state, there is a further inflation, e.g., (cl), before the final (d) elastic state.

[0154]

[0146] Figs. 8 to 12 show a schematic cross-section of another basic exemplary embodiment 1500 of a miniature catheter dilation tool 10 (“dilation tool 10”) in different states. As illustrated, distal and proximal directions are generally indicated by arrows marked DST and PRX, respectively. The practitioner operates proximally relative to the distal patient.

[0155]

[0147] Fig. 8 depicts a cross-section of an exemplary embodiment 1000 of a dilation tool 10 having an inflation tube 20 with an inflation lumen 22 and a distal, this time radial inflation aperture 24 over which a non-compliant polymer tube 40 is coupled after longitudinal elongation after a first deformation process. For the sake of orientation, the exterior diameter of the inflation tube 20 may be selected as desired or as the smallest available commercial product, or 0.75 mm (0.030"). The polymer tube 40 may be chosen with dimensions selected for ease of coupling to the inflation tube 20. Prior to coupling, the polymer tube 40 was thus deformed out of the initial state into a first deformation state by application of a first BIOMICRO-OOl PCT deformation process. This means longitudinally extension into a first state of deformation so that the nominal length L of the polymer tube is stretched from the initial state L to the longitudinally deformed state of length nL. Thereby, the initial exterior diameter OD of the polymer tube shrunk to ODim and the tube wall thickness t was reduced to t / q. In practice, the exterior diameter OD of the polymer tube may be reduced 3 folds, such as from about 0.75 mm (0.030") to about 0.25 mm, (0.010"). For example, the factor n may range from 1.2 to 2.5 or more, and the divisors m and q may range from 2 to 4 or more. Hence, the initial tube length L was elongated to and stretched tube length 1.3L or 1.4L, while the initial tube exterior diameter OD and the wall thickness may have decreased to the deformed tube exterior diameter ODD and the reduced tube wall thickness say t / 3. There may not be a direct proportional relation between the parameters n, m, and q.

[0156]

[0148] In Fig. 8, the proximal end 40P of the polymer tube 40 residing in the first elongated state of deformation is coupled to cover the distal portion 20P of the inflation tube 20 The proximal end 40P of the polymer tube 40 is locally firmly fixed and hermetically sealed to the distal end 20D of the inflation tube 20, at point XP proximal to the inflation aperture 24. Likewise, the distal end 40D of the polymer tube 40 is locally hermetically sealed at point (XD) for the polymer tube 40 to form a dilatable and hermetically sealed dilation envelope 42 that includes therein the inflation aperture 24.

[0157]

[0149] A locally fixed and hermetically sealed attachment point, such as disposed at the proximal and the distal fixation points, respectively (XP) and / or (XD), may be achieved in many ways, as well known to those skilled in the art. For example, a method for providing a hermetically sealed fixation and attachment may include heat fusing or gluing with one or more adhesives.

[0158]

[0150] Figs. 9 to 12 depict the inflation process of the non-compliant polymer tube 20 after having been submitted to the first deformation process:

[0159]

[0151] In Fig. 9, fluid under pressure P, or pressurized fluid P is supplied via the inflation tube 20 and exits through the radial inflation aperture 24 into the portion of the dilation tube 40, or dilation element 40 residing in the first deformation state. To return from the first deformation state to the second deformation state (and thus to undergo the second deformation process) the BIOMICRO-OOl PCT polymer tube 40 will require the application of significant force. Such force is provided by the pressurized liquid P which, for inflation, is introduced into the interior of the polymer tube 40 at a relatively high inflation pressure range Pa of about 15-20 atm. as shown in Fig. 4. In Fig. 9, the inflation is shown to start over the radial inflation tube aperture 24 covered by the polymer tube 40.

[0160]

[0152] To inflate the polymer tube 40 which forms the dilation tube 40, a practitioner may operate manually generated fluid pressure steps P to introduce predetermined volumes V of liquid into the dilation tube to cause inflation along steps S. In response to a first inflation step Pl, the proximal portion 40P of the non-complying polymer tube 40 has started to inflate the polymer tube distally along a first distance step SI and has returned the inflated portion to the initial exterior diameter 40D. It is noted the second deformation process applied by the pressure forces on the inflated portion of the polymer tube 40 causes the return thereof to the initial dimensions. Therefore, the length L of the polymer tube 40 is reduced proportionally to inflation progress.

[0161]

[0153] Fig. 10 illustrates a next distal direction inflation pressure step P2 following the injection of a volume V2 of liquid whereby inflation progresses along a second distance step S2. The direction of inflation occurs in distal direction, longitudinally along the inflation tube 20, is responsive to the inflation pressure steps P, and progresses in controlled successive distal distance steps S. Simultaneously, the length of the polymer tube 40 is reduced.

[0162]

[0154] Fig. 11 depicts the completion of the second deformation process whereby the non- compliant polymer tube 40, or dilation tube 40 forming the dilation envelope 42, is returned to initial dimensions and beyond therefrom but still in the plastic deformation range. The dilation tube 40 is now inflated at a pressure of about 18 - 20 atm. However, a further expansion of the dilation tube is possible, as shown in Fig. 6E.

[0163]

[0155] Figs. 13 to 17 show a schematic cross-section of a basic exemplary embodiment 100 of a miniature catheter dilation tool 10 (“dilation tool 10”). For ease of description and clarity of the drawings, embodiments of the distal nose assembly 70 have been deleted but are shown in Figs. 30 to 33.

[0164]

[0156] Fig. 13 depicts an inflation tube 20 having an inflation lumen 22 that supports an BIOMICRO-OOl PCT interior guide 30, a proximal portion 3 OP of which is disposed in the distal portion 20D of the inflation tube 20. The interior guide 30 and the inflation tube form a slider device 60. The interior guide 30 is thus a slider device 60 which is configured for bidirectional sliding in sliding fit in the inflation lumen 22. A distal portion 30D of the interior guide 30 may protrude distally out and away of the distal portion 20D of the inflation lumen 22. As illustrated, the distal and proximal directions are generally indicated by arrows marked DST and PRX, respectively. The practitioner operates proximally relative to the distal patient.

[0165]

[0157] The inflation tube 20 may have at least one radial inflation aperture 24 for the bidirectional passage therethrough of fluid, such as liquid. An inflation tube for the various embodiments of the present claimed invention may be made out of stainless steel, Nitinol, or another material known to those skilled in the art. The proximally-supplied pressurized liquid may flow through the inflation lumen 22 and through the radial inflation aperture 24. The flow direction of fluid under positive or negative pressure is indicated in the figures by an arrow marked P. A tube of polymer material 40 having an initial length L and an initial wall thickness t is used to form a dilation envelope 42, such as the dilation tube 40. According to the inherent properties of the material, the polymer dilation tube 40 may be stretched into a first deformation state of length nL wherein n is greater than 1. In the various embodiments of the present claimed invention, the factor n may range between 2 and 8, preferably between 2 and 6, and more preferably between 2.5 and 4. When deformed, e.g., in axial elongation, the dilation tube 40 may have an initial wall thickness that is reduced from the initial wall thickness t to t / m, wherein m is greater than 1. The divisor m may range between 2 and 6, and preferably between 2.5 and 4.

[0166]

[0158] The selected length of dilation tube 40 may be disposed in place over the inflation aperture 24 and may be stretched to cover the distal portion 20D of the inflation tube 20 and at least a portion of the interior guide distal portion 30D or slider device 60. If desired, the dilation tube 40 may be stretched further distally away to cover at least a portion of the distal nose assembly 70, shown in Figs. 30 to 33. Thereby, the stretched dilation tube 40 forms a dilatable and hermetically sealed dilation envelope 42 that covers the inflation aperture 24.

[0167]

[0159] The deformation of the inflation tube 20 increases the initial length L to nL, reduces BIOMICRO-OOl PCT the initial tube wall thickness t to t / m, and shrinks the dilation tube 40 in force-fit-like interference with the inflation tube 20 and the distal portion 30D of the interior guide 30, or slider device 60. This means that should the inflation tube 20 and the interior guide 30, or slider device 60 be made of metal, for example, the dimensions would correspond to a force fit interference according to the ISO System Limits. The initial length L of the dilation tube 40 is selected according to the required operative length of dilation, which may depend on the type of tissue, such as coronary, cerebral, or other intervention. Thereafter, the proximal extremity 40prx of the stretched dilation tube 40 may be fixedly attached and hermetically sealed locally to the inflation tube 20 at a proximal fixation point XP, proximal of the inflation aperture 24. Likewise, the distal extremity 40dst of the stretched dilation tube 40 may be fixedly attached and hermetically sealed locally to the slidable interior guide 30, either to the distal portion 30D at a distal fixation point XD, as shown in Figs. 13-16, or distally thereof, to the distal nose assembly 70, shown in Figs. 30-33. Thereby, the stretched dilation tube 40 forms a dilatable and hermetically sealed dilation envelope 42 that covers the inflation aperture 24. A locally fixed and hermetically sealed attachment point, such as disposed at the proximal and the distal fixation points, respectively XP o XD, may be achieved in many ways, as well known to those skilled in the art. For example, a method for providing a hermetically sealed attachment may include heat fusing or gluing with one or more adhesives.

[0168]

[0160] To inflate the dilation tube 40, proximally supplied fluid pressure P has first to be high enough to overcome the obstacle presented by the wall of the dilation tube 40 which is tightly stretched over and covers the inflation aperture 24. When the fluid pressure is the first pressure range Pa, e.g., above 18, 20, or 22 atm., the portion 40A of the dilation tube 40 that covers the inflation aperture 24 may start to lift off from over the inflation aperture. The fluid pressure also pushes the interior guide 30, or slider device 60 distally away.

[0169]

[0161] Inflation through an inflation aperture 24 which the polymer tube 40 covers in force fit requires work to overcome the resistance hindering the intake of liquid. Inflation via a resistance-offering inflation aperture 24 is alike the forceful introduction of liquid against a resisting force since the dilation tube 40 resists the ingress of inflation liquid. Such a forcerequiring introduction of liquid may be compared for example, to the use of liquid under BIOMICRO-OOl PCT pressure which is necessary to push and displace a constant force spring-loaded piston guided in a cylinder.

[0170]

[0162] It is noted that with a spring-loaded piston, the liquid fills incrementally, in stepwise incremental volumes which gradually push the piston in one direction. This means that the stepwise introduction of volumes of pressurized liquid controls the displacement of the piston away from the inflation aperture while the liquid remains confined and accumulates as a cylindrical volume having the cross-section of the cylinder. The cylindrical volume V of pressurized liquid P thus grows in length away from the inflation aperture and up to the piston. This is not the case with a compliant catheter balloon having an open liquid intake wherein liquid may flow uncontrollably away from the intake. However, a directional inflation progression proportional to the volume of liquid injection steps is in agreement with the inflation progress of the dilation tube 40. One may also say that for inflation of the dilation envelope 42, proximally supplied fluid pressure P introduced through the inflation aperture 24 has to perform a second deformation process on the polymer tube 40. It is the second deformation process that returns the polymer tube 40 to about the initial dimension, or initial state, and allows further inflation in the plastic range.

[0171]

[0163] Fig. 14 illustrates a partial cross-section of the schematic exemplary embodiment 100 after an initial inflation volume VI of liquid at pressure Pl is injected through the lumen 22, via the inflation aperture 24, and into the dilation tube 40. The portion 40A of the dilation tube 40 which is disposed opposite the inflation aperture 24 is first lifted-off radially away from the inflation tube 20 by the pressure Pl applied thereto, to return to the initial exterior diameter OD. Simultaneously, the pressurized liquid also performs a second deformation process on the portion 40A of the polymer dilation tube 40 which is disposed opposite the inflation aperture 24. The second deformation process causes a return to initial conditions, whereby the polymeric material shrinks back to, or close to, its initial 'memorized' shorter length L and returns to the initial wall thickness t. Thereby, the deformed portion 40A of the polymer tube 40 has regained the initial pre-stretched initial state dimensions. Hence, the polymer tube 40, now after the second deformation process, no longer forcefully blocks the inflation aperture 24, which remains open for passage therethrough of fluid, either injected or evacuated. BIOMICRO-OOl PCT

[0172]

[0164] The initial inflation volume VI at pressure Pl may deform the portion 40A of the polymer dilation tube 40, and form a local inflation bulge 40B which, after further inflation at pressure P, expands and grows into an inflated circumferential torus Tl. The exterior diameter of the torus Tl which has lifted off the inflation aperture 24, has now reached the initial exterior diameter OD of the non-compliant polymer tube 40. Since the proximal fixation point XT is disposed proximal to the inflation aperture 24, the torus Tl cannot but extend distally away therefrom along the inflation tube 20, and grow along a distance step si. The inflated distance si covered by the torus Tl of the dilation tube 40, may be measured for example, starting from the inflation aperture 24 or from another reference locus.

[0173]

[0165] The recovery of the inflated portion of the polymer dilation tube 40 shrinks the polymer material back to its initial conditions, i.e., the conditions before the first deformation process. In response thereto, the non-inflated portion of the polymer tube 40 is pulled proximally. Hence, the distally disposed polymeric material of the dilation tube 40 is pulled. Thereby, the interior guide 30, or slider device 60 is pulled back in a proximal direction, say along a retraction sliding step distance SI. The length of the dilation tool 10 and of the dilation tube 40 is thus reduced by the length SI of the retraction sliding step distance.

[0174]

[0166] Liquid under pressure may be supplied under manual control of the operator by use of a trigger-operated device. The hydraulic pressure forces applied to the inflated portion of the dilation tube 40 operate a second deformation process thereon and cause the polymeric material to locally return to initial conditions. In other words, the polymeric material exhibits its inherent behavior of being a "memory" material and thus regains initial dimensions and configuration, i.e., of length, wall thickness, and polymer chains configuration. In response to inflation, the inflated portion of the dilation tube 40 regains the initial wall thickness t and the prior-to-stretching length L. This reversal to prior-to-stretching length shrinks or reduces the length of the dilation tube 40 subjected to inflation, but not the still uninflated portion thereof. In consequence, a portion of the distally disposed but still uninflated inflation tube 40 is retracted, or 'dragged' proximally by the shrunken proximal portion, together with the coupled interior guide 30. Hence, a first or initial inflation step Pl urges the interior guide 30 to slide proximally into the lumen 22 along, for example, a first sliding retraction sliding step distance BIOMICRO-OOl PCT

[0175] SI. After inflation of the dilation tube 40 into a first inflation stage, return to the initial state and beyond in the plastic range, further inflation at increased high-pressure inflation steps Pn will drive the dilation tube 40 into elastic deformation range, to reach a maximal exterior diameter of DMax. The exterior diameter of DMax may increase the nominal exterior diameter OD of the polymer tube 40 by about 5% to 10%. Notably, the exterior diameter may be round or oval / elliptical.

[0176]

[0167] Fig. 14 illustrates that the initial liquid pressure inflation step Pl has opened a passage for liquid via the inflation aperture 24. Although the inflation aperture 24 remained open after being opened by the first inflation step Pl, the yet uninflated portion, and thus the undeformed portion of the polymer tube 40 still clings to the inflation tube 20 in force-fit-like interference. Therefore, to further inflate the dilation tube 40, pressurized liquid of at least 18 to 20 or 22 atmospheres is necessary to lift the polymer tube 40 off and radially away therefrom. In Fig. 15, after an additional inflation step P2 injecting an increased inflation volume V2, the inflated torus T1 has grown distally into a larger torus T2. As before, dilation progresses along a second inflated distance step s2, which has further deformed the inflated portion of the polymer dilation tube 40. The inflation tool 10 and the polymer dilation tube have shortened by a sliding retraction proximal step distance S2, and the interior guide 30, or slider device 60, have retracted proximally by the same distance S2.

[0177]

[0168] Fig. 16 illustrates the fully inflated or first stage of inflation of the dilation tube 40 after the injection of VI to Vn volumes of inflation liquid in successive respective inflation steps si to sn, at a respective pressure Pl to Pn. The suffixes i to n are positive integers. One may say that the dilation tube 40 has returned to the initial state after the application of the second deformation process applied by the pressure forces. The inflation tool 10 and the polymer dilation tube have shortened by retraction in the proximal direction, along Sn distance steps S3, and the interior guide 30, or slider device 60, have retracted proximally by the same distance Sn.

[0178]

[0169] Fig. 17 depicts the dilation tool 10 after inflation in the elastic deformation range. The exterior diameter of the polymer tube 40 has exceeded initial dimensions and further inflation in the plastic deformation range and now has an exterior diameter of ODmax, thus at maximum BIOMICRO-OOl PCT inflation pressure of 30 atm. diameter OD. For example, the maximal exterior diameter ODmax of the dilation device 40 may reach the value of OD x 1.1, thus about 10% more than the initial diameter OD.

[0179]

[0170] The inflation by the consecutive inflation steps Pi to Pn, where the suffix 'i' is a positive integer, generated a pattern of progression in successive distally directed inflation distance steps si, where the suffix 'i' is a positive integer. The progressive directional inflation by inflation distance steps si is thus commanded according to the successive pressure steps Pi. There is thus provided a mechanism for the control of the progress of the directional inflated distance si of the dilation tube 40, here distally along the inflation tube 20. A mechanism for the control of the inflated distance si is an advantageous feature, beneficial for example, to prevent displacement in unwanted direction of plaque or arteriosclerotic material, in a bifurcation of a blood vessel, as described with reference to Figs. 18 to 21. As described hereinbelow, control of the direction of inflation along the inflation tube 20 is dependent on the location of the inflation aperture 24 with respect to the proximal and distal fixation points, respectively XP and AD, of the dilation tube 40. Fig. 18 shows a bifurcation of a blood vessel, Fig. 19 depicts an inflated commonly available balloon catheter, and Figs. 20 to 21 refer to the dilation tool 10 of the invention.

[0180]

[0171] Fig. 18 illustrates an exemplary blood vessel BV which bifurcates into a first blood vessel branch and a second blood vessel branch, respectively BV1 and BV2. Plaque PLQ, or arteriosclerotic material PLQ, is shown to clog to the entrance of the first blood vessel branch BV1.

[0181]

[0172] Fig. 19 depicts a known catheter balloon CB used in an attempt to widen a passage through a stenosis in the plaque PLQ of the first blood vessel branch BV1. The known catheter balloon CB is disposed in the stenosis and is inflated therein, but since the direction of progress of the inflation of the balloon is not controllable and does not grow longitudinally, some of the flattened plaque PLQ may be driven into the second blood vessel branch BV2 and might cause blockage thereof. Moreover, if BV2 is distal to the plaque, its growth due to the flattening of the CB will lead to the closing of BV2. BIOMICRO-OOl PCT

[0182]

[0173] In Fig. 20, a dilation tool 10 according to one embodiment of the invention has been navigated and disposed in position in operative association with a lesion in the blood vessel branch BV1. Alternatively, a dilation tool 10 may be guided into its position using a disposition tool, such as a guide wire or a micro-catheter. A proximal portion 40P of the dilation tube 40 is disposed of just ahead of the entrance of the first blood vessel branch BV1 and a distal portion 40D thereof is disposed in the stenosis. The proximal portion 40P of the dilation tube 40 is shown to have started directional inflation by successive inflated distance steps si, and to have started penetration through and dilation of a portion of the stenosis. Fig. 21 depicts how the longitudinal progress of the inflation steps si of the dilation tube 40, has succeeded in flattening and dislocating the stenosis in the distal direction, due to the longitudinal direction of progress of the inflation steps. The proximal to distal direction of inflation of the dilation tube 40 has thus prevented the spill-over displacement of plaque PLQ into the second blood vessel branch BV2 as observed in Fig. 19. If necessary or desired, a different but appropriate dilation balloon catheter of a larger diameter may be introduced in the first blood vessel branch BV1 to further expand the first widened-up passage in the stenosis. Directional inflation progress is thus advantageous.

[0183]

[0174] According to the embodiment described hereinbelow, a dilation procedure in a branch of a bifurcation may proceed not only from the proximal to the distal direction, but also from the distal to the proximal direction. Most importantly, it becomes possible to direct and shift the arteriosclerotic material PLQ away from the bifurcation. Such a directional inflation procedure performed in one branch of a blood vessel bifurcation also prevents the shifting of plaque PLQ and prevents interference of shifted plaque PLQ with the blood flow in the other blood vessel branch.

[0184]

[0175] Figs. 22 and 23 illustrate respectively, a schematic cross-section and a partial cross section, of an additional exemplary embodiment 200 of the dilation tool 10. For ease of description and clarity of the drawings, embodiments of the distal nose assembly 70 have been deleted but are shown in detail in Figs. 30 to 33.

[0185]

[0176] Fig. 22 shows the dilation tool 10 before inflation of the dilation tube 40, as well as the distal portion 20D of the inflation tube 20 which is firmly affixed at X30P to the proximal BIOMICRO-OOl PCT portion 30P of the interior guide 30. A tubular distal rail 50 has a rail lumen 52 that is configured to receive therein the interior guide 30 in a sliding fit friction. This means that when so urged, the distal rail 50 may slide proximally over the interior guide 30. The interior guide 30 and the distal rail 50 form a slider device 60. The stretched dilation tube 40 is hermetically sealed at XP, proximally adjacent to the inflation aperture 24, and stretches from there distally away to be hermetically sealed to the distal portion 50D, either at XD, or distally of the distal portion 50D, as shown in Fig. 22, or to the distal portion of the distal nose assembly 70. Thereby, the dilation tube 40 forms a hermetically sealed dilation envelope 42 that covers the inflation aperture 24. Fig. 23 illustrates a partial cross-section of the distal portion 10D of the dilation tool 10 after the inflation process described hereinabove has started. The bulge 40B has grown and progressed distally away. Evidently, the hermetical fixation point XP proximal the inflation aperture 24 prevents proximal dilation of the dilation tube 40. In response to the inflation pressure, the inflated portion of the polymer tube 40 undergoes a second deformation process and recovers initial dimensions. The recovery process shrinks the length of the inflated portion of the dilation tube 40 whereby the distal rail 50 of the slider device 60 is retracted in proximal translation over the interior guide 30. The exemplary embodiment 200 operates in principle in the same manner as the embodiment 100 but has a structure featuring distal rail 50, absent in the embodiment 100.

[0186]

[0177] Figs. 24 and 25 exhibit a schematic, respectively, cross-section and partial crosssection of another exemplary embodiment 300 of the dilation tool 10. For ease of description and clarity of the drawings, embodiments of the distal nose assembly 70 have been deleted but are shown in detail in Figs. 30 to 33.

[0187]

[0178] In Fig. 24, the inflation tube 20 receives the interior guide 30 in sliding friction fit into the inflation lumen 22. The distal portion 20D of the inflation tube 20 supports the proximal portion 3 OP of the interior guide 30. The distal portion 30D of the interior guide 30 is firmly fixed at 30XD to the proximal portion 50P of the distal rail 50. The interior guide 30 and the distal rail 50 form the slider device 60. Thereby, the interior guide 30 may slide proximally towards the inflation aperture 24. The dilation tube 40 is fixedly coupled in hermetic sealing disposition at XP, which is proximally adjacent to the inflation aperture 24. Distally, the BIOMICRO-OOl PCT dilation tube 40 may be fixedly coupled in hermetic sealing disposition, to the proximal portion 50P of the slider device 60, either at XD, or distally of the distal portion 50D, as shown in Fig. 25, or to the distal portion of the nose assembly 70. Thereby, the stretched dilation tube 40 forms an elastic and hermetically sealed dilation envelope 42 that covers the inflation aperture 24. Furthermore, when urged by the distal rail 50, the interior guide 30 is configured to slide proximally in the direction of the inflation aperture 24.

[0188]

[0179] Fig. 25 illustrates a partial cross-section of the distal portion 10D of the dilation tool 10 after the inflation process described hereinabove has started. The bulge 40B has grown and progressed distally away. Evidently, the hermetical fixation point XP proximal to the inflation aperture 24 prevents proximal dilation of the dilation tube 40. In response to the inflation pressure, the inflated portion of the polymer tube 40 undergoes a second deformation process, recovers initial dimensions, and may still be inflated further in the plastic deformation range. The recovery process shrinks the length of the inflated portion of the dilation tube 40 whereby the interior guide 30 of the slider device 60 is retracted in proximal translation into the lumen 22 of the inflation tube 20. The exemplary embodiment 300 operates in principle in the same manner as the embodiment 200 but has a slider device 60 of a slightly different structure.

[0189]

[0180] Figs. 26 and 27 schematically depict a further exemplary embodiment 400 of the dilation tool 10, operable for proximal directional inflation of the dilation tube 40. For ease of description and clarity of the drawings, embodiments of the distal nose assembly 70 have been deleted and but shown in detail in Figs. 30 to 33.

[0190]

[0181] Fig. 26 is a partial cross-section showing the inflation of the dilation tube 40 after a first inflation step Pl. Contrary to the embodiments 100 to 300, the dilation tube 40 is affixed in hermetical sealing disposition proximally away from the inflation aperture 24, instead of adjacent thereto. Hence, the hermetically sealed fixation location XP and XD are disposed respectively, proximally and distally away from the inflation aperture 24. Upon the first pressure inflation step Pl, in the same manner as with the embodiments 100 to 300, first a bulge 40BD appears opposite the inflation aperture 24, which bulge further grows into a torus T1 after more inflation steps. BIOMICRO-OOl PCT

[0191]

[0182] In Fig. 27 the pressurized fluid inflates the dilation tube 40, both proximally and distally towards the hermetically sealed fixation locations, respectively XP and XD. It may thus be possible to inflate the dilation tube 40 up to the hermetically sealed points XP and XD. The embodiment 400 is actually similar to the embodiment 100 wherein the location of the inflation aperture 24 is appropriately disposed to allow inflation to progress in two opposite directions, namely proximally and distally.

[0192]

[0183] Although not shown in the figures, embodiments 200 and 300 may also be modified to provide bidirectional inflation propagation by appropriate location of the inflation aperture 24 relative to the hermetically sealed fixation points XP and AD. Such reconfigured embodiments 200 and 300 may thus both be referred to as respectively, embodiments 500 and 600. Hence, with the embodiments 400 to 600, directional inflation is oriented to progress both proximally and distally.

[0193]

[0184] For the embodiments of the present claimed invention, there is thus provided a mechanism for controlling the: (a) stepwise longitudinal progress of the inflation of the dilation tube 40, possibly along the inflation tube 20, and (b) one or more direction(s) of inflation. This means that control is provided over the actual length of inflation of the dilation tube 40. The desired length of inflation may start at the inflation aperture 24 and extend away therefrom until the desired length is reached. This also means that control is provided over the one or more direction(s) of inflation, possibly along the inflation tube 20 by appropriate selection of the disposition or location of the inflation aperture 24 relative to the hermetically sealed fixation location points XP and XD.

[0194]

[0185] Figs. 28A and 29A schematically illustrate yet another exemplary embodiment 700 of the dilation tool 10, wherein the inflation tube 20 supports a plurality of inflation apertures 24. As with the prior embodiments 100 to 600, the inflation process starts at the inflation apertures 24, here 241 and 242, by the creation of a bulge BL, here BL1 and BL2. Control of the stepwise progress of the length of inflation is maintained, and so is control over the one or more proximal and / or distal direction(s) of inflation relative to the location of the hermetically sealed fixation location points XP and AD. For the sake of ease of description, only two such inflation apertures 24 are shown in Figs. 28A and 29 A, namely a first inflation aperture 241 which is BIOMICRO-OOl PCT proximal to the second inflation aperture 242. Fig. 28A is a schematic partial cross-section showing the inflation of the dilation tube 40 after the first inflation step Pl. Liquid pressure is provided through the inflation lumen 22 to the plurality of inflation apertures 241 and 242. Contrary to the embodiments 100 to 600, the inflation tube 20 may carry a longitudinally distributed, but not necessarily aligned distribution of a plurality of inflation apertures 24. The dilation tube 40 may be fixedly attached and hermetically sealed to the proximal portion of the inflation tube 20 at XP, proximally of the most proximal inflation aperture here 241, and distally away, to a distal portion of the dilation tool 10, at XD as shown in Fig. 28A, or to a portion of the distal nose assembly 70, shown in Figs. 30 to 33.

[0195]

[0186] Fig. 29A schematically shows the progress of the inflation following successive pressure steps Pi in both proximal and distal directions towards the hermetically sealed fixation points, respectively XP and AD. For example, three such successive pressure steps Pl, P2, and P3 are shown in Fig. 29 A, progressing in both proximal and distal directions. The embodiment 700 is actually a modification of the embodiment 400 which is configured for bidirectional inflation progress, thus proximal and distal, but here the inflation tube 20 may be provided with a longitudinal distribution of a plurality of inflation apertures 24. The embodiment 700 may support different slider devices 60, with an interior guide and with both an interior guide 30 and a distal rail 50.

[0196]

[0187] Figs. 28B and 29B schematically illustrate yet another exemplary embodiment 800 of the dilation tool 10, wherein the inflation tube 20 supports a plurality of inflation apertures 24. As with the prior embodiments 100 to 600, the inflation process starts at the inflation apertures 24, here 243, 244, and 245, by the creation of a bulge BL, here BL1, BL2, and BL3. Control of the stepwise progress of the length of inflation is maintained, and so is control over the one or more proximal and / or distal direction(s) of inflation relative to the location of the hermetically sealed fixation location points XP, XM, and XD. For the sake of ease of description, only three such inflation apertures 24 are shown in Figs. 28B and 29B, namely a first inflation aperture 243 which is proximal to the second inflation aperture 244, which in turn is distal of the second inflation aperture 245. Fig. 28B is a schematic partial cross-section showing the inflation of the dilation tube 40 after the first inflation step Pl. Liquid pressure is BIOMICRO-OOl PCT provided through the inflation lumen 22 to the plurality of inflation apertures 243 to 245. Contrary to the embodiments 100 to 600, the inflation tube 20 may carry a longitudinally distributed, but not necessarily aligned distribution of a plurality of inflation apertures 24. The dilation tube 40 may be fixedly attached and hermetically sealed to the proximal portion of the inflation tube 20, at the fixation location point XP which is disposed of proximally away from the most proximal inflation aperture here 243, at the intermediate fixation location point XM which is disposed distally away of the most proximal inflation aperture 243 and is indicated here as inflation aperture 244 which is proximally adjacent to the at the inflation aperture 244, and distally away of the most distal inflation aperture here 245, to a distal portion of the dilation tool 10, at XD as shown in Fig. 28B, or to a portion of the distal nose assembly 70, shown in Figs. 30 to 33.

[0197]

[0188] Fig. 29B schematically shows the progress of the inflation following successive pressure steps Pi in both proximal and distal directions towards the hermetically sealed fixation points, respectively XP, XM, and XD. For example, three such successive pressure steps Pl, P2, and P3 are shown in Fig. 29B, progressing in both proximal and distal directions. It is noted that the progress of inflation is bidirectional with the inflation apertures 241 and 243, but distal for the inflation aperture 242. The embodiment 800 is actually a modification of the embodiment 400 which is configured for bidirectional inflation progress, thus proximal and distal, but here the inflation tube 20 may be provided with a longitudinal distribution of a plurality of inflation apertures 24. The embodiment 800 may support different slider devices 60, with an interior guide and with both an interior guide 30 and a distal rail 50.

[0198] Distal Guide Assemblies

[0199]

[0189] Distal guide assemblies may facilitate the guidance of a dilation tool 10 to a selected target location and through a lesion in the vasculature.

[0200]

[0190] Figs. 30 and 31 depict exemplary embodiments of a distal nose assembly 70, respectively 701 and 702. The various exemplary embodiments 100 to 700 may preferably support a distal nose assembly 70 which may simply be configured as an elongation of the distal portion of the slider device 60, the distal portion of which is either an interior guide 30 or a distal rail 50. BIOMICRO-OOl PCT

[0201]

[0191] Fig. 30 depicts an exemplary embodiment 701 of a distal nose assembly 70 wherein the distal portion 30D of the interior guide 30 according for example to the embodiments 100 and 400. The distal guide assembly 70 may include a wire extension 72, having an exterior diameter 72d that may be thinner than the exterior diameter 30ex of the interior guide 30, and ranging from 0.007"- 0.06" in diameter. The distal portion 72D of extension 72 may be rounded off, or have a nose piece 74 of desired shape. A radiopaque marker 76, such as a wound platinum wire may be disposed in and be coupled to the wire extension 72. Alternatively, or additionally, a tubular radiopaque marker, and / or radiopaque bands 77, and / or other desired markers may be coupled to the wire extension 72, in a manner well known to those skilled in the art. If desired, although not shown in the figures, the wire extension 72 may be bent to facilitate navigation.

[0202]

[0192] Fig. 31 shows an exemplary embodiment 702 of a distal nose assembly 70 wherein the distal portion 50D of the distal rail 50 is described for example with respect to the embodiments 200 and 300. The distal guide assembly 70 may have a nose cone 78 which is disposed in the lumen 52 and is supported at the distal portion 50D of the distal rail 50. The distal nose assembly 70 may extend distally into a wire extension 72 having a conic distally diminishing external diameter, the distal portion 72D of which may have a nose piece 74 of spherical or other shape. The distal portion of the dilation envelope 40D may be affixed and hermetically sealed to a desired portion of the distal rail 50 or of the wire extension 72, but is not shown in Fig. 31 for the sake of clarity.

[0203]

[0193] Although not shown in Fig. 31, radiopaque markers 76, or radiopaque bands 77, or other marker devices, such as marker wires, well known to those skilled in the art, may be coupled to the distal nose assembly 70 and / or to other portions of the dilation tool 10. If desired, although not shown in the figures, the wire extension 72 may be bent to facilitate navigation.

[0204]

[0194] Figs. 32 and 33 illustrate further exemplary embodiments of a distal nose assembly 70 which may be coupled to the distal portion of a slider device 60 selected as either an interior guide 30 or as an interior guide 30 supporting a distal rail 50.

[0205]

[0195] Fig. 32 depicts another exemplary embodiment 703 of a distal nose assembly 70 wherein an interior guide 30 supporting a tubular distal rail 50 in the distal portion 50D of BIOMICRO-OOl PCT which a radial rail opening 50RO is opened proximal of the rail's distal opening 50DO. From the distal direction, a guide wire GW may be introduced into the distal opening 50DO and into the lumen 52, to exit distally out of the radial rail opening 50RO. The dilation tool 10 may thereby be guided along the guide wire GW to a target location by an operator, not shown in the figures. The distal portion of the dilation envelope 40D may be affixed and hermetically sealed on a selected distal portion 50D of the distal rail 50, for example at a distal fixation point XD. If desired, although not shown in the figures, the distal portion 50D may be bent to facilitate navigation.

[0206]

[0196] Fig. 33 shows a further exemplary embodiment 704 of a distal nose assembly 70 wherein the distal portion 30D of an interior guide 30 supports an axial bore 30B having a distal bore opening 30DO and a radial guide opening 30RO. From the distal direction, a guide wire GW may be introduced into the distal bore opening 30DO and into the lumen 30B to exit proximally out of the radial guide opening 30RO. The dilation tool 10 may thereby be guided along the guide wire GW to a target location, by an operator (not shown in the figures). The distal portion of the dilation envelope 40D may be affixed and hermetically sealed on a desired distal portion 30D of the interior guide 30, for example at a distal fixation point XD. If desired, although not shown in the figures, the distal portion 30D may be bent to facilitate navigation.

[0207]

[0197] In certain embodiments, the device is compatible with “over-the-wire”, as well as “rapid exchange” configurations.

[0208]

[0198] Figs. 44 and 45illustrate another embodiment of the distal portion of a dilation tool 10 in deflated and inflated states, respectively.

[0209]

[0199] In Fig. 44, the balloon envelope formed from polymeric material (4321) is shown in its deflated and longitudinally stretched configuration, closely conforming over the core wire (4312). The distal tip of the core wire is equipped with a radiopaque coil (4311), secured to the core wire by soldering or laser welding at fixation point (4310). Proximally, a radiopaque marker coil (4314A) is disposed around the core wire in an open-pitch configuration corresponding to the balloon’s deflated state. The proximal end of the radiopaque marker coil is mechanically locked to the core wire at locking interface (4316A). This mechanical lock is achieved by a bond (4315) between the marker coil (4314A) and the surrounding wire tube BIOMICRO-OOl PCT

[0210] (4317).

[0211]

[0200] The polymeric balloon material (4321) is bonded proximally to the shaft (4320) at connection (4319) and distally to the tip region through a tether element (4313). The shaft (4320) is connected to the wire tube (4317) via a proximal bond (4318). In this deflated state, the radiopaque marker coil (4314 A) is stretched with open pitch, providing a distinct radiographic appearance indicating that inflation has not yet occurred.

[0212]

[0201] In Fig. 45, the balloon envelope (4321) is shown in the inflated state. Inflation causes axial retraction of the core wire (4312) relative to the balloon, which compresses the radiopaque marker coil into a closed-pitch configuration (4314B). This action releases the mechanical lock at (4316A), resulting in the formation of a visible axial gap (4316B) between the marker coil and the core wire. The change from open-pitch coil (4314 A) to closed-pitch coil 4314B alters the radiographic density, providing a clear visual cue under fluoroscopy that the balloon has been inflated.

[0213]

[0202] The distal tip coil 4311 and its attachment at 4310 remain unchanged between the two figures, ensuring consistent distal visibility and structural stability. The tether 4313 maintains alignment between the balloon and the core wire throughout the transition from deflated to inflated states.

[0214]

[0203] With reference to Fig. 47, an embodiment of the dilation tool 10 is shown comprising a metallic core wire 4613 extending distally to a tip portion 4610. The core wire 4613 is fabricated from stainless steel or nitinol and is shaped to have a conical taper by centerless grinding, for example from about 0.006 inches to about 0.002 inches, and then flattened to a thickness of about 0.001 inches. The flattened distal configuration of the core wire is shown in the magnified view 4611 and provides improved flexibility and navigational control within tortuous vasculature.

[0215]

[0204] The distal end of the core wire 4613 is secured to the tip 4610 by soldering, laser welding, or adhesive bonding. The tip assembly includes a radiopaque marker coil 4612 mechanically and electrically coupled to the core wire 4613 at the connection point 4610. The coil 4612 may be formed from a platinum -tungsten alloy, preferably comprising about 92 % platinum and about 8 % tungsten, although palladium or other radiopaque materials possessing BIOMICRO-OOl PCT suitable mechanical properties may also be used. The coil diameter may range from about 0.008 inches to about 0.014 inches.

[0216]

[0205] The radiopaque coil 4612 is coupled proximally to a multi-strand wire tube 4614, which may be composed of flat or round stainless steel strands, providing enhanced torque response and pushability. Disposed along the wire tube 4614 is a balloon section 4615, which is encapsulated by a polymeric material 4617 forming an inflatable dilation envelope. A distal radiopaque balloon marker 4616 is located within the balloon section 4615 to provide fluoroscopic visualization of balloon position during use.

[0217]

[0206] The proximal end of the wire tube 4614 is joined to a hypotube 4619 through a connection tube 4618. Both the connection tube 4618 and the hypotube 4619 may be formed from stainless steel or nitinol to provide strength, kink resistance, and compatibility with high- pressure inflation.

[0218]

[0207] At the proximal extremity, the device is provided with a detachable on-off hub 4620. The hub 4620 includes a silicone valve configured to maintain a fluid-tight seal during balloon inflation and deflation. This arrangement enables selective injection of pressurized inflation fluid through the hypotube 4619 to the balloon section 4615, and also permits removal of the hub 4620 to allow the dilation tool 10 to function as a guidewire for the delivery of balloon catheters, stents, or other interventional devices over the same track.

[0219]

[0208] In operation, the configuration shown in Fig. 47 enables precise navigation of the distal tip 4610, clear radiographic visualization via the radiopaque markers 4612 and 4616, efficient force transmission through the wire tube 4614 and hypotube 4619, and controlled inflation of the balloon section 4615, all while providing the option of converting the assembly for guidewire use without device exchange.

[0220] BIOMICRO-OOl PCT

[0221] Repeated Inflation

[0222]

[0209] The term 'deflation' and derivatives thereof, is used herewith for 'emptying', or 'draining' of fluid such as liquid. Furthermore, the term 're-inflation' and derivatives thereof, is understood to mean 'repeated inflation', or 'next inflation', as occurring after previous inflation. Both terms may be used in conjunction with the description of additional stenosis dilation(s) following a previous dilation procedure.

[0223]

[0210] Once a dilation tool 10 has performed a dilation procedure, the operator may want to proceed further distally and perform a next stenosis dilation operation. Thereby, the tedious, expensive, and to the patient, traumatic routine of retrieval of the dilation tool 10 out of the vasculature, and reinsertion of the same or another type of dilation tool into the stenosis, may be saved. To prevent such inconvenience, the dilation tool 10 may be returned to the first deformation state by operation thereon of the first deformation process. In other words, the dilation tool 10 may be returned to a prior-to-first-use or previous-use condition, which will allow the next dilation procedure. This means that for the next operation: at least the inflated portion of the dilation tube 40 has to be deflated, i.e. evacuated, at least the deflated portion of the dilation tube 40 has to be returned to the first deformation state dimensions, and thereafter, the dilation tool 10 has to be appropriately guided and disposed relative to a target location or a next stenosis to be dilated.

[0224]

[0211] Thereafter, the dilation tool 10 has to be appropriately guided and disposed relative to a target location or a next stenosis to be dilated. This may be achieved with the dilation tool 10 as is, or with the help of a guidance or disposition tool 80, such as a micro -catheter 80 or, e.g., a guide wire GW.

[0225]

[0212] Deflation of the inflated dilation tube 40 is a simple and well-known procedure since the inflation aperture 24 and the lumen 22 allow the bidirectional flow of liquid. In the same manner as pressurized fluid is injected from a proximally disposed source of pressure, that fluid may be evacuated out of the inflated portion by use of a proximally disposed source of suction. The dilated portion of the dilation tube 40, i.e. the previously inflated distance steps s, shown for example in Figs. 14-15 as si and s2, is that deformed portion of the dilation tube 40, or polymer tube 40, that must return to the first deformation state dimensions. BIOMICRO-OOl PCT

[0226]

[0213] Return of the inflation tool 10 to the first deformation state geometrical dimensions is described hereinbelow with respect to Figs. 34 to 36.

[0227]

[0214] Fig. 34 schematically depicts the distal portion 80D of a guidance tool 80, such as a catheter or a micro-catheter 80 which supports a deflated dilation tool 10, wherein the deflated portion of the dilation tube 40 is figuratively shown and is indicated by the numeral 84. At least the deflated portion 84 must be restored to the first deformation state dimensions, a goal which is obtained with the help of the dedicated configuration of the distal portion 80D of the guidance tool 80.

[0228]

[0215] Fig. 35 schematically illustrates a cross-section through the distal portion 80D of the guidance tool 80 and depicts the dilation tool 10 carrying a deflated portion 84, which usually has a flattened shape of width 40ext. The distal portion 80D may be shaped as an inlet funnel 82 of generally conical shape, with the wider opening pointing distally.

[0229]

[0216] Preferably, the inlet funnel 82 has a rounded-off smooth surface finish and is void of sharp edges. Evidently, other inlet funnel 82 shapes may also be practical. It is the inlet funnel 82 which is used to mechanically restore the deflated portion 40def to the first deformation state dimensions, which dimensions refer to those of the polymer tube 40 and the condition of the dilation tool 10 before the first inflation or before a previous use.

[0230]

[0217] If desired, the inlet funnel 82 may be configured as a unitary machine part that is coupled, by means known in the art, to the distal portion 80D of the guidance tool 80, such as a micro-catheter 80 or a catheter 80.

[0231]

[0218] Fig. 36 illustrates a relative disposition of the inlet funnel 82 and of the deflated portion 84, wherein the inlet funnel 82 is shown in partial engagement over a proximal section 8P of the deflated portion 84. Such a disposition is achieved for example by holding the inflation tube 20 in place at a standstill and translation thereover of the inlet funnel 82. Alternatively, since relative translation motion is required, the inlet funnel 82 may be held in place at a standstill and the inflation tube 20 may be pulled therein. With the distal opening of the inlet funnel 82 over the polymer tube 40, the former operates as an extrusion die which performs a second deformation process on the deflated portion 84. This means that the inlet funnel 82 ingests and deforms the deflated portion 84 back into the shape obtained by the application of BIOMICRO-OOl PCT the first deformation process. It is the extrusion process operated by the inlet funnel 82 that mechanically deforms at least the deflated portion 84 of the polymer tube 40, which is returned to the length nL and the wall thickness t / m dimension shown in Fig. 5B. Further distal translation of the inlet funnel 82 over the dilation tool 10 operates on the interior guide 30, or slider portion 60, which is returned to the distal disposition before inflation. Preferably, extrusion by distal translation of the inlet funnel 82 over the entire length of the dilation tool 10 is applied up to the distal fixation point XD of the polymer tube 40.

[0232]

[0219] In Fig. 36, the proximal section 84P of the deflated portion 84, which is not seen, has been flattened out and treated, but not yet so for the remaining distal untreated section 84D thereof. Operating like a die, the inlet funnel 82 has 'extruded' the proximal section of the deflated portion 84 which is flattened out to the thickness t / m. The exterior flattened dimension 84 of the deflated polymer tube 40 was treated by the interior diameter 86 of the lumen of the guidance tool 80, or micro-catheter 80 as shown in Fig. 36. The interior diameter 86 is appropriately selected to operate the first deformation process necessary to return the polymer tube 40 to the first deformation state. Preferably, as shown in Fig. 37, the inlet funnel 82 is driven over almost the entire length of the inflation tool 10, or at least far enough for the slider arrangement 60 to return to the initial distally extended disposition.

[0233] OPERATION OF THE DILATION TOOL

[0234]

[0220] An exemplary repeated operation of the inflation tool 10 for the dilation of plaque PLQ in a blood vessel BV is described hereinbelow with respect to Figs. 37 to 42. The plaque PLQ is shown as a first stenosis STN1 and a second stenosis STN2. Fig. 37 illustrates the guidance tool 80, or micro-catheter 80 and the dilation tool 10 in disposition in a blood vessel BV which is partially obstructed by plaque PLQ. The micro-catheter 80 which supports the dilation tool 10 therein has been driven distally to the target location by the practitioner, just proximally off and for engagement with the first stenosis STN1. The dilation tool 10 is small enough to penetrate through a stenosis having a passage that is not smaller than about 0.25 mm in diameter. BIOMICRO-OOl PCT

[0235]

[0221] As shown in Fig. 38, the micro-catheter 80 has remained in place at a standstill but the dilation tool 10 has been extended there out distally. The inflation tube 20 has been pushed distally into, through, and out of the interior of the first stenosis STN1 which has to be widened.

[0236]

[0222] Fig. 39 depicts the final inflation for dilation in the elastic deformation range applied to the dilation tool 10. Such final inflation is the result of the injection of liquid at a pressure exceeding about 20atm but below 30atm. Liquid under pressure is supplied from a source that is disposed proximally, and the inflation steps Pi are controlled and preferably manually commanded by the practitioner. The non-compliant dilation tool 10 is inflated into elastic over inflation as shown in Fig. 12 for example.

[0237]

[0223] It is noted that when the entire operational length of the polymer tube 40 is inflated at a pressure of about 20 atm., the exterior diameter OD of the polymer tube 40 as shown in Fig. 5, may still be increased by inflation in the elastic deformation range. This means that by increasing the pressure of the liquid to above about 20 atm. , but still below 30atm, an advantage is taken of the elastic range of the non-compliant polymer tube 40 which will further inflate elastically, approximately up to an exterior diameter ODmax larger by 5% to 10% than OD. However, care is taken to prevent a pressure of liquid in excess of 30atm, which may be close to the burst pressure of the polymer tube 40.

[0238]

[0224] To proceed with the next dilation procedure, it may be necessary for the dilation tool 10 to first be deflated and, if necessary, returned to the first deformation state. This means that the dilation tube 40 must be deflated, thus vacated, to be returned to the first deformation state condition and that the slider device 60 has to be pushed distally. These operations have been described hereinabove with respect to Figs. 34 to 36.

[0239]

[0225] Fig. 40 shows the deflated dilation tube 40 and the first stenosis STN1 which has been widened by the dilation tool 10. The first dilation has thus been completed and the dilation tool 10 may now be retrieved out of the vasculature or be returned to the first deformation state by sliding along the length thereof of the micro-catheter 80, prior to a repeated dilation procedure. For a repeated dilation procedure, the dilation tool 10 must be disposed in engagement with the next stenosis, as shown in Fig. 32. In Fig. 41, the micro-catheter 80 is brought at the target location for engagement of the second stenosis STN2, and the dilation tool 10 has been BIOMICRO-OOl PCT extended thereout by pushing the inflation tube 20 distally. In turn, the dilation tool 10 is disposed in the interior of the second stenosis STN2.

[0240]

[0226] In Fig. 42, the dilation tube 40 has been inflated in the final elastic deformation range to the diameter ODmax, to widen the second stenosis STN2, by which the dilation tool 10 is disposed at the same state of operation as shown in Fig. 39. Hence, the dilation procedure may proceed as described hereinabove. After deflation, the dilation tool 10 may now be retrieved out of the vasculature or else, may be returned to the first state of deformation to proceed with a further operation.

[0241]

[0227] There has thus been described a dilation tool 10 having a dilation envelope 42 and a method for manufacturing such a non-compliant dilation envelope 42 which is coupled to an inflation tube 20. The dilation tool 10 thus comprises an inflation tube 20 for inflating the dilation envelope 42. An initial length of a piece of an off-the-shelf polymer tube 40 having an initial state is cut to length. The polymer tube 40 is deformed by longitudinal stretch in the plastic deformation range. Then, the polymer tube is coupled to the inflation tube which provides liquid under pressure and is configured to form the hermetically sealed inflatable dilation envelope 42. The inflation fluid is injected at a first pressure range Pa and at a second pressure range Pb, where the second pressure Pb is higher than the first pressure range Pa. The first pressure range Pa inflates the dilation envelope back to the initial state and still further in the plastic range, thus beyond the initial state, and finally the second pressure range Pb inflates the dilation envelope 42 in still further deformation in the elastic range.

[0242]

[0228] The pressure ranges Pa and Pb depend mainly on the type of polymer material from which the polymer tube 40 is made and its thickness. Evidently, the second pressure Pb has to be inferior to the burst pressure of the polymer tube.

[0243]

[0229] The inflation tube 20 may support one or more inflation apertures 24 of axial and radial type, and / or one or more of both axial and radial aperture. The inflation apertures allow to determine the direction of inflation of the dilation envelope 42, either distally or proximally away from an inflation aperture 24. Moreover, the dilation envelope 42 may be inflated gradually by controlled inflation distance steps s and inflation may progress controllably over a predetermined distance along the dilation envelope 42. The polymer tube 40 may be BIOMICRO-OOl PCT hermetically sealed to the inflation tube 20 at least twice. First, once proximally of the at least one inflation aperture 24, at a proximal location XP or fixation point XP, and second, at least once distally at a distal location XD, or distal fixation point XD of the dilation tool 10. Inflation of the dilation envelope 42 may proceed away from an inflation aperture, either distally, or proximally, or both, distally and proximally away therefrom. This means that according to a selected combination of a distribution of inflation apertures 24, and to a therewith appropriate selection of proximal and distal location fixation points XP and XD, it becomes possible to provide various patterns of directional inflation. Hence, the dilation envelope 42 may have various sections and simultaneously have one or more section(s) with inflation proceeding in the distal direction, other sections(s) with inflation proceeding in the proximal direction, and in addition, further sections(s) with inflation proceeding opposite to each other in the proximal and distal directions.

[0244]

[0230] The dilation tool 10 may be configured to inflate the envelope 42 once, thus for one inflation procedure, or be configured for successive inflation procedures. This means that if necessary, the dilation tool 10 may be redressed or reshaped in situ, after a previous inflation procedure, and then continue and perform the next inflation procedure.

[0245]

[0231] To perform a dilation procedure, the dilation tool 10 has to be disposed in operative position to engage a stenosis. Guidance towards a target such as a stenosis may be selected for example, either as an unassisted guidance, or as assisted guidance by guide wire GW, or be performed under the guidance of a catheter 80, or a micro-catheter 80, or another known guidance tool 80.

[0246]

[0232] In an embodiment of the dilation tool 10, the inflation tube 20 may support a slider device 60, such as for example an interior guide 30, or an interior guide 30 and a tubular distal rail 50. A slider device 60 may support one of the embodiments of a distal nose assembly 70.

[0247]

[0233] The hermetically sealed dilation tool 10 may have a proximal fixation point XP and a distal fixation point XD. An inflation aperture 24 may be disposed between the proximal and the distal fixation points, respectively XP and XD. With such a disposition, the inflation of the dilation envelope 42 may progress in at least one direction which is oriented away from the inflation aperture 24. Furthermore, the inflation progresses controllably along a controlled BIOMICRO-OOl PCT inflation distance s, which inflation distance extends at most until inflation is arrested by both the proximal and the distal fixation points, respectively XP and XD.

[0248]

[0234] Furthermore, the hermetically sealed dilation tool 10 may have a proximal fixation point XP and a distal fixation point XD between which a plurality of inflation apertures 24 are distributed. Inflation of the dilation envelope 42 may progress in at least one direction oriented away from an inflation aperture. Inflation may progress along a controlled inflation distance, which inflation may extend at most until inflation is arrested by both the proximal and the distal fixation points.

[0249]

[0235] In addition, the hermetically sealed dilation tool 10 may have a proximal fixation point XP, at least one intermediate fixation point XM, and a distal fixation point XD between which inflation apertures 24 are disposed. Inflation of the dilation envelope 42 progresses in at least one direction oriented away from the inflation apertures 24 along a controlled inflation distance which inflation extends at most until inflation is arrested by both the fixation points.

[0250]

[0236] It is noted that after inflation of the dilation envelope 42, an additional inflation may require the evacuation of fluid out of at least the portion of the dilation envelope that was inflated. After evacuation, the dilation tube 40 may be returned to the prior-to inflation condition by use of a forming tool.

[0251]

[0237] It is further noted that application of the second deformation process which returns the polymer tube 40 to the initial state causes the dilation envelope 42 to shrink.

[0252] BIOMICRO-OOl PCT

[0253] EXAMPLES

[0254] Example 1

[0255] Non-Compliant Balloon Fabrication Using Selective Thermal Reversion of Stretched PET Tubing

[0256]

[0238] This process describes a novel method for manufacturing non-compliant microballoons directly integrated with a catheter shaft, using thin-wall heat shrink PET tubing and leveraging a material phenomenon involving controlled thermal reversion.

[0257] Material Background

[0258]

[0239] Polyester (PET) is chosen due to its excellent dimensional stability, strength, and suitability for forming thin-wall, high-performance heat-shrink tubing. Its application includes protective coverings and sealing components for medical devices such as braided catheter shafts and spring coils. Notably, PET's response to heat after mechanical deformation is central to this process.

[0259] Overview of the Manufacturing Process

[0260]

[0240] Tubing Preparation: A PET tube is selected and radially expanded (stretched) to approximately 35% of its original outer diameter OD. The axial length after stretching is typically 30 cm. This stretching induces orientation in the polymer chains, imparting mechanical memory to the tube.

[0261]

[0241] Balloon Formation Principle: PET exhibits a reversion behavior under heat, tending to return toward its original molded dimensions when reheated, especially under pressure. If the stretched PET tube is pressurized with a liquid above 20 atm, it reverts to or near its original OD. This property is harnessed to define the balloon portion.

[0262]

[0242] Selective Reversion via Heat Shielding: To localize balloon formation: (a) a heat- resistant barrier (heat shield) is applied around a discrete segment of the stretched PET tube - the intended balloon location; (b) the remaining length of the tube is exposed to hot air at 120 °C, while the masked section remains unheated; and (c) the heated, unmasked PET conforms and adheres to the underlying porous catheter shaft, effectively sealing it and preventing expansion under pressure. BIOMICRO-OOl PCT

[0263]

[0243] Integrated Balloon and Shaft Assembly: After thermal bonding: (a) the tube is pressurized, triggering reversion only in the masked segment, which regains its original OD and forms the balloon; (b) the rest of the tube, now thermally fixed and adhered to the shaft, maintains its stretched profile and does not expand; and (c) the result is a non-compliant balloon with a fixed maximum OD, directly integrated with the shaft - eliminating the need for secondary bonding or molding processes.

[0264]

[0244] Advantages of the Process: (a) No bonding required between the balloon and the catheter shaft - mechanical and thermal integration is achieved in a single step; (b) No mold required - the balloon forms based on material memory and controlled heating, reducing manufacturing complexity and cost; (c) Precise control of balloon length and location via heat shielding; (d) Improved reliability - fewer interfaces reduce the risk of delamination or leakage; and (e) Minimized compliance - balloon maintains fixed dimensions under pressure, ideal for procedures like Percutaneous Transluminal Coronary Interventions (PTCI).

[0265]

[0245] Potential Applications are: Coronary angioplasty (PTCI), Peripheral vascular intervention, Neurovascular microcatheters, and High-pressure delivery systems.

[0266] BOM - Bill of materials BIOMICRO-OOl PCT

[0267] Example 2

[0268] Device Description and Principles of Operation

[0269] Device Description

[0270]

[0246] A Ninja™ 0.014” guide wire with integrated balloon dilation is a low-profile, singleuse device designed to assist in crossing tight or occluded coronary lesions and to facilitate the subsequent advancement of therapeutic balloon catheters.

[0271]

[0247] In its navigation mode, the Ninja™ functions similarly to a conventional guidewire, providing excellent steerability and torque transmission. Once positioned across a lesion, the device’s integrated distal micro-balloon-capable of inflating up to 1.0 mm-is deployed under operator control using a standard inflation device. This controlled inflation gently dilates the micro-channel created during navigation, facilitating smooth passage of interventional tools such as standard PTC A catheters.

[0272]

[0248] The Ninja™ is compatible with 0.014” interventional systems and is supplied sterile for single use.

[0273] Indications for Use

[0274]

[0249] The Ninja™ guide wire with integrated micro-balloon is intended to: (a) Facilitate the placement and advancement of interventional devices during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PT A); and (b) Perform controlled dilatation of narrowed coronary segments using a distal micro-balloon to enable the subsequent advancement of therapeutic balloon catheters or other interventional devices. BIOMICRO-OOl PCT

[0275] Device Description and Principles of Operation (illustrated, e.g.. in Fig. 47)

[0276]

[0250] Distal Tip: The Ninja™ 0.014” guidewire tip is shaped from a stainless steel core wire 4613 that gradually narrows from an OD of 0.0045” to 0.0025” with a 10 mm flat end that helps in shaping the tip to the desired shape with a thickness of 0.0015” to provide the tip with the flexibility required for a traumatic advancment. The core wire segment is 45 mm in length. The tip is equipped with a 35 mm in length palladium coil 4612 which is used for radiopacity, secured in place by solder in the distal end (bond 1) to the distal end of the core wire, tip closure 4610 and at the proximal end (bond 2) to the core wire 4613.

[0277]

[0251] Distal Shaft: Ninja™ 0.014” guidewire distal shaft is made from a stainless steel wire tube 4614. The 22cm floppy stainless steel wire tube ensures sufficient flexibility of the device's distal shaft and proper torque transfer to the tip. The wire tube is covered in PET shrink tubing 4617 for maintaining inner pressure and outer smoothness. 5 mm from the distal end of the PET shrink tubing is the location of the balloon 4615 capable of expanding to 1mm in diameter when pressurized to nominal pressure. The distal end of the PET shrink tubing is shrunk and heat-bonded to the core wire (bond 3) For radiopacity detection, a single L-lmm platinum marker 4616 is located at the center of the balloon location. It is bonded by solder (bond 4) to the wire tube 4614. The distal end of the wire tube is connected by solder (bond 5) to the proximal end of the core wire 4613.

[0278]

[0252] Distal Shaft / Proximal Shaft connection: The ultra flexible distal shaft is connected to the 150cm long main shaft 4619 with a L=10mm nitinol shaft connector 4618, it is glue bonded (bond 6). The proximal shaft is a 0.014” diameter super elastic hypo tube with an ID of 0.01” to provide good pushability and support.

[0279]

[0253] Inflation port: The connection to the inflator at the device proximal end is done by a standard “off the shelf ’ inflation connector 4620 made from polycarbonate and silicone that is removable from the device, enabling the insertion of standard catheters over the device after inflation and deflation. The device is supplied with the connector in place, and the seal is tested before packaging (temporary bond 7).

[0280]

[0254] Bonding Joints: There are 7 bonded joints in the Ninja™ 0.014” (mentioned above). All bonded joints are tested and validated. Bonding is provided either by Sn96.5Ag3Cu0.5 BIOMICRO-OOl PCT solder, heat bonding, or by Medical Grade Cyanoacrylate glue that is commonly used for catheters, surgical tools, and more. This cyanoacrylate is compatible with ETO sterilization methods and meets the biocompatibility standards for ISO 10993 and USP Class VI. The bonding points are: a) Bond 1 - Distal connection of the distal tip structure 4610: (solder bonding) b) Bond 2 - Distal connection of the proximal end of the palladium coil 4612 to the core wire (3): (glue bonding) c) Bond 3 - connecting the distal end of the PET shrink 4617 to the core wire 4613: (heat bonding) d) Bond 4 - Connecting the platinum marker 4616 to the wire tube 4614: (solder bonding) e) Bond 5 - Connecting the distal end of the wire tube 4614 to the proximal end of the core wire 4613: (solder bonding) f) Bond 6 - connecting the distal shaft to the main shaft with the shaft connector 4618: (glue bonding) g) Bond 7 - connecting temporarily the main shaft 4619 to the inflator connection 4620 (manual on / off fast silicone removable connector).

[0281]

[0255] The different bonds are illustrated in the images depicted in Figs. 51A, 51B, and 52.

[0282] Example 3

[0283] Clinical use of the dilation tool of the inveniton

[0284]

[0256] Figs. 46A-46F illustrate a clinical use case of the dilation tool 10 for restoring blood flow in a side branch of a coronary artery following main vessel stenting, in this example in the right coronary artery of a swine model. The sequence demonstrates the treatment of a blockage in a large diagonal branch caused by plaque shift during percutaneous coronary intervention (PCI).

[0285]

[0257] Fig. 46A shows the right coronary artery after deployment of a stent in the main vessel. The stent is visible along the vessel path, and a large diagonal branch originates upwardly from the main vessel. The diagonal branch is not opacified with contrast medium, indicating blockage at its ostium due to the plaque shift phenomenon, in which expansion of the main BIOMICRO-OOl PCT vessel stent displaces plaque material into the side branch.

[0286]

[0258] Fig. 46B depicts the distal portion of the dilation tool 10 advanced through the stent struts toward the entrance of the diagonal branch. The radiopaque distal tip coil 4311 of the dilation tool is visible under fluoroscopy, facilitating precise navigation through the stent strut openings into alignment with the blocked side branch.

[0287]

[0259] Fig. 46C illustrates the dilation tool 10 after successful advancement into the diagonal branch. The balloon envelope 4321 of the dilation tool is positioned at the ostium of the side branch, within the strut structure of the previously implanted stent, ready for inflation.

[0288]

[0260] Fig. 46D shows the dilation tool 10 in an inflated state. The balloon envelope 4321 has been expanded within the stent strut at the side branch ostium, displacing the obstructive plaque material and restoring partial patency. The distal end of the dilation tool extends beyond the ostium into the diagonal branch, ensuring stability and correct positioning during inflation. Contrast medium injection highlights the inflated balloon inside the stent.

[0289]

[0261] Fig. 46E depicts a conventional balloon catheter advanced over the dilation tool 10 and into the diagonal branch after initial access was created by the dilation tool. The conventional balloon is inflated to further expand the side branch ostium and optimize vessel lumen restoration.

[0290]

[0262] Fig. 46F shows the final procedural result. Contrast injection demonstrates full opacification of the diagonal branch, confirming restoration of blood flow. The dilation tool 10 remains positioned within the diagonal branch, maintaining access through the stent struts during the intervention.

[0291] BIOMICRO-OOl PCT

[0292] List of Reference Signs BIOMICRO-OOl PCT BIOMICRO-OOl PCT

Claims

BIOMICRO-OOl PCTClaims:

1. A dilation tool 10 for a balloon catheter, comprising:(i) an inflation tube 20 having an inflation lumen 22 and at least one inflation aperture 24; and(ii) a polymer tube 40 coupled to the inflation tube 20 and forming a hermetically sealed inflatable dilation envelope 42, wherein the polymer tube 40 has an initial state and an initial exterior diameter OD, and is configured to exhibit a dual-phase inflation behavior such that:(a) upon inflation with a fluid at a first pressure range Pa, the dilation envelope 42 inflates in a compliant manner, returning from a pre-stretched state to substantially its initial exterior diameter OD, and further into a plastic deformation range beyond said initial exterior diameter OD; and(b) upon continued inflation with said fluid at a second pressure range Pb, higher than said first pressure range Pa, the dilation envelope 42 inflates in a non-compliant manner into an elastic deformation range, wherein its exterior diameter (DMax) increases by about 5% to 10% beyond said initial exterior diameter OD.

2. The dilation tool 10 of claim 1, wherein inflation of the inflation tube 20 results in an increase in its diameter and a decrease in its length.

3. The dilation tool 10 of claim 1, wherein the at least one inflation aperture 24 is configured to control a direction of inflation of the dilation envelope 42 in at least one of a distal direction, a proximal direction, or both, thereby enabling inflation of the dilation envelope 42 to proceed in controlled inflation distance steps si along the inflation tube 20, away from the at least one inflation aperture 24.

4. The dilation tool 10 of claim 3, wherein the at least one inflation aperture 24 is selected as one out of at least one axial inflation aperture, at least one radial inflation aperture, and at least one axial and one radial inflation aperture 24.BIOMICRO-OOl PCT5. The dilation tool 10 of claim 3, wherein:- the polymer tube 40 is hermetically sealed to the inflation tube 20 at a proximal fixation point XP, and at a distal fixation point X )- the at least one inflation aperture 24 is disposed between said proximal XP and distal XD fixation points; and- inflation of the dilation envelope 42 proceeds in at least one direction out of a distal, a proximal, or both a distal and a proximal direction, respective to a disposition of the proximal fixation points? and of the at least one inflation aperture 24.

6. The dilation tool 10 of claim 1, further comprising an internal coil housed within the dilation envelope 42, wherein pressurization and deflation of the dilation envelope 42 cause said coil to extend a guidewire forward.

7. The dilation tool 10 according to claim 6, wherein the internal coil is constructed from a radiopaque material and is configured to compress axially and contract radially upon inflation, thereby increasing its local radiographic density for real-time visual confirmation of balloon expansion under fluoroscopy.

8. The dilation tool 10 of claim 1, wherein the hermetically sealed inflatable envelope 42 is configured for in situ successive repetition of inflation procedures.

9. The dilation tool 10 of claim 8, wherein a guidance tool 80 is configured to return a deflated portion or an entirety of the dilation envelope 42 into an operative condition, i.e., a prior-to-inflation condition, after a prior inflation.

10. The dilation tool 10 of claim 9, wherein the guidance tool 80 comprises an inlet funnel 82 configured to mechanically restore the deflated portion of the dilation envelope 42 to a first deformation state.

11. The dilation tool 10 of claim 1, wherein disposition in an operative position and guidance to a target location is carried out using unassisted guidance, a guide wire GW guidance, or a micro-catheter 80 guidance.BIOMICRO-OOl PCT12. The dilation tool 10 of claim 1, wherein the inflation tube 20 together with an interior guide 30 form a slider device 60 configured for bidirectional sliding within the the inflation lumen 22 in response to inflation and deflation of the dilation envelope 42.

13. The dilation tool 10 according to claim 12, wherein the slider device 60 comprises an interior guide 30 and / or a tubular distal rail 50.

14. The dilation tool 10 of claim 11, wherein the slider device 60 comprises a distal nose assembly 70.

15. The dilation tool 10 of claim 1, which comprises a coil designed to be positioned within said balloon catjetjer, wherein said coil is constructed from a radiopaque material.

16. The dilation tool 10 according to claim 1, configured as a micro-dilation tool having an exterior diameter of about 0.2 mm in its pre- inflation state.

17. A method for manufacturing a dilation tool 10 for a balloon catheter, the method comprising the steps of:(a) providing a polymer tube 40 having an initial state and an initial exterior diameter OD'.(b) longitudinally stretching said polymer tube 40 to deform it into a first plastic deformation range, thereby reducing its exterior diameter and increasing its length; and(c) coupling the stretched polymer tube 40 to an inflation tube 20 to form a hermetically sealed inflatable dilation envelope 42 in fluid communication with the inflation tube 20.

18. The method according to claim 17, further comprising steps:(d) inflating the dilation envelope 42 with a fluid at a first pressure range Pa to cause the dilation envelope 42 to return to substantially its initial exterior diameter OD and further inflate in a plastic deformation range; and(e) subsequently inflating the dilation envelope 42 with said fluid at a second pressure range Pb, higher than said first pressure range Pa, to cause the dilation envelope 42 to inflate into an elastic deformation range, wherein its exterior diameter increases by about 5% to 10% beyond said initial exterior diameter OD.BIOMICRO-OOl PCT19. The method according to claim 17, wherein step (c) further comprises:(cl) applying a heat-resistant barrier (heat shield) around a discrete segment of the stretched polymer tube 40 corresponding to an intended balloon location;(c2) exposing remaining unmasked portions of the stretched polymer tube 40 to heat to cause said unmasked portions to conform and adhere to an underlying catheter shaft, thereby sealing said unmasked portions and preventing their expansion under pressure; and(c3) pressurizing the polymer tube 40 to trigger reversion only in the masked segment, thereby forming the dilation envelope 42 directly integrated with the catheter shaft without external bonding or molding.

20. The method according to claim 19, wherein the heat applied in step (c2) is hot air at about 120°C.

21. The method of claim 17, wherein the dilation envelope 42 is hermetically sealed at a proximal fixation point XP and at a distal fixation point XD, between which fixation points an inflation aperture 24 is disposed.

22. The method of claim 17, wherein the dilation envelope 42 is hermetically sealed at a proximal fixation point XP and at a distal fixation point XD between which a plurality of inflation apertures 24 are distributed.

23. The method of claim 17, wherein the dilation envelope 42 is hermetically sealed at a proximal fixation point XP, at an intermediate fixation point XM, and at a distal fixation point XD, between which inflation apertures 24 are disposed.

24. The method of claim 17, wherein the polymer tube 40 is first deformed into a predetermined length by longitudinal stretching and thereafter, inflation of the dilation envelope 42 by the second deformation process reduces its predetermined length.

25. The method according to claim 17, wherein the longitudinal stretching in step (b) radially expands the polymer tube 40 to approximately 35% of its original outer diameter.BIOMICRO-OOl PCT26. The method of claim 17, wherein inflation of the dilation envelope 42 progresses in at least one direction oriented away from an inflation aperture 24 along a controlled inflation distance, in which inflation extends at most until inflation is arrested by both the proximal and the distal fixation points.

27. The method of claim 17, wherein at least one additional inflation of the dilation envelope 42 requires evacuation of at least an inflated portion of the dilation tube 40 and return thereof to a prior-to-inflation condition.

28. The method of claim 17, wherein inflation of the inflation tube 20 results in an increase in its diameter and a decrease in its length.

29. A method for controlling the inflation and dilation of a dilation balloon of a balloon catheter, the method comprising:(a) providing a dilation tool 10 for a balloon catheter according to claim 1, the dilation tool 10 comprising an inflation tube 20 associated with a polymer tube 40, wherein:- the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and- upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD, and(b) after positioning the dilation tool 10 at a desired location within a patient’s blood vessel, inflating the polymer tube 40 by applying a first fluid pressure range Pa followed by aBIOMICRO-OOl PCT second increased fluid pressure range Pb, with Pb > Pa, via the inflation tube 20 for deforming the dilation envelope 42 by inflation respectively, first back to the initial state and beyond therefrom in the plastic deformation range, and second, into elastic deformation range to a predefined diameter.

30. A method for treating a blood vessel’s blockage, the method comprising the steps of:(a) providing a dilation tool 10 for a balloon catheter according to claim 1, the dilation tool 10 comprising an inflation tube 20 associated with a polymer tube 40, wherein:- the polymer tube 40 has an initial length and an initial state that is capable of being deformed by longitudinal stretch into a plastic deformation range and is configured to form a hermetically sealed inflatable dilation envelope 42 that is coupled to the inflation tube 20; and- upon addition of an inflation fluid into the polymer tube 40 through the inflation tube 20 at a first pressure range Pa and at a second pressure range Pb which is higher than Pa, the dilation envelope 42 inflates, respectively: first in a compliant manner back to the tube’s initial state reaching an initial exterior diameter OD, beyond which it is in the plastic deformation range; and second, in a non-compliant manner, into an elastic deformation range, in which the tube’s exterior diameter grows further by about 5 to 10% beyond said initial exterior diameter OD, and(b) positioning the dilation tool 10 at a desired location within a patient’s blood vessel, inflating the polymer tube 40 by applying a first fluid pressure range Pa followed by a second increased fluid pressure range Pb, with Pb > Pa, via the inflation tube 20 for deforming the dilation envelope 42 by inflation respectively, first back to the initial state and beyond therefrom in the plastic deformation range, and second, into elastic deformation range to a predefined diameter.

31. The method of claim 30, for treating Chronic Total Occlusions (CTO).

32. The method of claim 30, wherein inflation of the dilation envelope 42 progresses in at least one direction oriented away from an inflation aperture 24 along a controlled inflation distance, in which inflation extends at most until inflation is arrested by both the proximal and the distalBIOMICRO-OOl PCT fixation points.

33. The method of claim 30, wherein at least one additional inflation of the dilation envelope 42 requires evacuation of at least an inflated portion of the dilation tube 40 and return thereof to a prior-to-inflation condition.

34. The method of claim 30, wherein a micro-guidance tool 80 is operative to return the dilation tool 10 into operative condition after a prior inflation.

35. The method of claim 30, wherein inflation of the inflation tube 20 results in an increase in its diameter and a decrease in its length.

36. A balloon on a wire system comprising a guidewire and an internal coil, wherein the coil is housed within a pressurizable balloon segment, and wherein balloon pressurization and deflation cause the coil to extend the guidewire forward through total occlusions.

37. A minimaly invasive medical device comprising an internal coil which is constructed from a radiopaque material and is configured to compress axially and contract radially, thereby increasing its local radiographic density for real-time visual confirmation under fluoroscopy.

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