Systems and methods for a balloon catheter support sleeve

Abstract

Systems and methods for a balloon catheter support sleeve. System and method for widening a narrow blood vessel in a patient, the system including a guidewire, a balloon catheter having a widening balloon, and a tubular support sleeve having at least one support balloon. The support balloon is inflated to mechanically support the advancement of the balloon catheter into a narrow segment of the blood vessel.

Description

/ 21 “SYSTEMS AND METHODS FOR A BALLOON CATHETER SUPPORT SLEEVE” CROSS-REFERENCE WITH RELATED ORDERS

[001] The present request is based on and claims priority for United States Provisional Patent Application No. 62 / 841,997, filed May 2, 2019, and entitled “Balloon Catheter Support Sleeve,” which is incorporated herein by reference in its entirety for all purposes. BACKGROUND

[002] Within the human body, blood vessels can become narrowed. Arteries, for example, can narrow into distinct segments in disease states, such as coronary artery disease. To widen narrowed blood vessels, angioplasty can be performed, in which a balloon catheter, sometimes having a stent attached to the balloon for dispensing, is fed through the circulatory system to the narrowed vessel and inflated. In some cases, however, the narrowed vessel is tortuous or calcified, making insertion of the balloon catheter into the narrowed vessel segment challenging because the balloon catheter has little or no physical support to help propel it through the narrowed vessel.

[003] Before inserting the balloon catheter, physicians sometimes use a guiding extension device, which sets a flexible hollow tube into the circulatory system. The guiding extension device can be fed through the patient's vasculature until it is seated near the narrowed vessel segment. This device can provide support for a balloon catheter that is fed through the hollow channel of the guiding extension device. However, some guiding extension devices are very difficult to advance in certain types of coronary anatomy, cannot provide adequate support, recoil when the balloon catheter is attempted to advance, and there is a risk of dissection when contrast injection is performed because the Petition 870210107021, dated 11 / 19 / 2021, page 6 / 33 / 21: the guidance extension device is inside the artery, and they are typically very expensive. SUMMARY OF THE DISCLOSURE

[004] It is an aspect of the present disclosure to provide a support sleeve for use with a balloon catheter. The support sleeve includes a sleeve portion, a support balloon, and an inflation tube. The sleeve portion is tubular in shape and has an inner diameter of a size and shape to receive a balloon catheter. The support balloon is attached to an outer surface of the sleeve portion. The inflation tube is in fluid communication with the support balloon and a fluid source, the fluid source being for inflating the support balloon and the support sleeve being removablely attached to the balloon catheter.

[005] In some embodiments, the support sleeve additionally includes a coupling portion that selectively couples the support sleeve to the balloon catheter.

[006] In some embodiments, the coupling portion is a wire configured to contact the balloon catheter and a surface of the sleeve portion to restrict relative movement between the balloon catheter and the support sleeve.

[007] In some embodiments, the coupling portion is a wire and a winch, the wire has a loop that is received around the balloon catheter and the winch with the wire looped around the balloon catheter is configured to tighten or loosen the wire loop to selectively restrict or allow relative movement between the balloon catheter and the support sleeve.

[008] In some embodiments, the support balloon is configured to be inflated to a diameter approximately equal to the diameter of a blood vessel adjacent to a narrowed blood vessel segment within a patient.

[009] In some embodiments, the support balloon comprises: a first support balloon and a second support balloon, in Petition 870210107021, dated 11 / 19 / 2021, page 7 / 33 / 21, states that the first support balloon is positioned to inflate outward from the outer surface of the glove portion and the second support balloon is positioned to inflate inward from an inner surface of the glove portion.

[0010] In some embodiments, the inflation tube is a hypotube.

[0011] The precedent and other aspects and advantages of the present disclosure will appear from the following description. In the description, reference is made to the accompanying drawings which form part thereof, and in which a preferred embodiment is shown by way of illustration. This embodiment does not necessarily represent the complete scope of the invention, however, and therefore reference is made to the claims in this document to interpret the scope of the invention. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] FIG. 1 shows a support sleeve according to one embodiment.

[0013] FIG. 2 shows a system for widening a narrow passage within a patient's body according to one embodiment.

[0014] FIG. 3 shows the system of FIG. 2 having an inflated support balloon.

[0015] FIG. 4A shows a partial view of a support sleeve according to one embodiment.

[0016] FIG. 4B shows a cross-section through the partial view of the support sleeve shown in FIG. 4A.

[0017] FIG. 5 shows a side view in cross section of a system for widening a blood vessel.

[0018] FIG. 6 shows a side view in cross section of another system for widening a blood vessel.

[0019] FIG. 7 shows a flowchart of a process for widening a narrowed blood vessel according to one embodiment. Petition 870210107021, dated 11 / 19 / 2021, p. 8 / 33 / 21 DETAILED DESCRIPTION

[0020] This document describes systems and methods for widening a narrowed blood vessel within a patient. The embodiments described in this disclosure facilitate the advancement of the angioplasty balloon catheter and stent catheter, which in some cases may be after the lesion has been crossed with a guidewire, in arteries that are tortuous and / or calcified. In many cases, the advancement of balloon catheters can be challenging due to inadequate guide support. When the balloon catheter encounters resistance, the guide catheter may be pushed out of the coronary artery ostium and the balloon catheter cannot advance.

[0021] With reference first to FIG. 1, a support sleeve 10 according to one embodiment is illustrated. The support sleeve 10 includes an inflation tube 12, a tubular sleeve portion 14, and a support balloon 16. In general, the tubular sleeve portion 14 is sized to receive a catheter, such as a balloon catheter. The support balloon 16 is coupled to the outer surface of the tubular sleeve portion 14 so that, when inflated, the support balloon extends away from the outer surface of the tubular sleeve portion 14 to make contact with the inner surface of the lumen of a vessel. The inflation tube 12 and the support balloon 16 are in fluid communication with each other, so that a syringe can be coupled to the inflation tube 12 and air, liquid, or other fluid can be injected through the inflation tube 12 into the support balloon 16 in order to expand the support balloon 16.The inflation tube 12 can be a hypotube or any small tube having a diameter that allows the inflation tube 12 to be fed through a patient's vascular system.

[0022] The support balloon 16 may be made of a flexible material so that the support balloon 16 can reach its fully inflated diameter with very little pressure applied by the syringe. In a non-limiting example, in the fully inflated state, the support balloon 16 is Petition 870210107021, dated 11 / 19 / 2021, page 9 / 33 / 21 expands into a spherical shape having a diameter approximately equal to the diameter of the artery where the support sleeve 10 will be placed during a blood vessel dilation procedure. The extent of inflation of the support balloon 16 will depend on the fluid pressure applied through the syringe. In other configurations, the support balloon 16 may have different shapes or geometries. After inflation, the support balloon 16 firmly holds the support sleeve 10 in place within the blood vessel and may act as a structure against which the balloon catheter 24 can be advanced. In some embodiments, and as illustrated in FIG. 1. The support balloon 16 extends around the entire circumference of the glove portion 14; however, in alternative configurations, the balloon 16 may extend along a portion of the circumference of the glove portion 14 (for example, an arc length of the circumference of the glove portion 14).

[0023] In some forms, the support sleeve 10 may include multiple support balloons 16. In these cases, some support balloons 16 may be positioned to expand from the outer surface of the tubular sleeve portion 14 to contact and press against the inner wall of a patient's blood vessel. This configuration prevents the support sleeve 10 from drifting away from the narrowed blood vessel segment. Some support balloons 16 may be positioned to expand inward from the inner surface of the tubular sleeve portion 14 to contact a guidewire 22 (FIGS. 2-3) that extends through the tubular sleeve portion 14. This configuration helps prevent recoil of the balloon catheter 24 during and after advancement of the balloon catheter 24 into the narrowed blood vessel segment.Support sleeve 10 can have any combination of support balloon configurations 16, such as two support balloons expanding outwards, two support balloons expanding inwards, one support balloon expanding inwards and one expanding outwards, and so on.

[0024] With reference to FIGS. 2 and 3, a system is shown Petition 870210107021, dated 11 / 19 / 2021, p. 10 / 33 / 21, to widen a narrow passage within a patient's body. The system 20 includes a guidewire 22, a balloon catheter 24 having an enlargement balloon 26, and a support sleeve 10. The balloon catheter 24 is advanced over the guidewire 22, and the support sleeve 10 has an inner diameter of a size and shape to receive the balloon catheter 24 in its deflated state. In use, the balloon catheter 24 and the guidewire 22 extend through the tubular sleeve portion 14. Thus, when the support sleeve 10 is placed for vessel enlargement, the inflation tube 12 and the guidewire 22 extend parallel backward through the circulatory system at the system 20 entry into the body.

[0025] In some forms, the support sleeve 10 includes a coupling portion and / or the balloon catheter 24 includes a coupling portion. The coupling portions may include an adhesive-based coupling, a mechanical coupling, or any other coupling arrangement that provides selective coupling of the support sleeve 10 to the balloon catheter 24. For example, the mechanical coupling may be additional balloons or a double-walled balloon, the expansion of which may hold the support sleeve 10 and the balloon catheter 24 together by friction. Furthermore, the mechanical coupling may include other friction mechanisms, scaffolding, or a hook-and-loop structure that provides selective coupling and uncoupling. The balloon catheter 24 has a distal end 28 and a proximal end 30, the distal end 28 being the main tip of the balloon catheter 24 and the proximal end 30 being located adjacent to a guidewire export port of the balloon catheter 24.

[0026] The coupling portions described above selectively couple the support sleeve 10 and the balloon catheter 24 so that the support sleeve 10 is positioned proximal to the enlargement balloon 26 of the balloon catheter 24, but distal to the export port of the guidewire. In some other cases, the support sleeve 10 may be coupled to the distal end of the balloon catheter 24, so that the support sleeve 10 is the leading edge of the combined device that is introduced into the patient's vasculature. The support sleeve 10. Petition 870210107021, dated 11 / 19 / 2021, p. 11 / 33 / 21 can be selectively coupled and uncoupled from the balloon catheter 24 so that the support sleeve 10 and the balloon catheter 24 can be advanced together through the patient's vasculature, but the balloon catheter 24 can also be advanced separately from the support sleeve 10 once the system 20 reaches the narrowed blood vessel segment.

[0027] FIG. 4A shows a top view of another system 50 for enlarging a passage within a patient's body, which is a specific implementation of system 20. Thus, the previous description of system 20 also applies to system 50. System 50 also includes a support sleeve 52 and a balloon catheter 54. As shown in FIG. 4A, the support sleeve 52 has a region with layers that have been removed to expose more internal layers for visual clarity. Thus, the layers (or components) of the support sleeve are generally intended to be arranged coaxially with respect to each other and to extend along an axis (axial direction) together, as shown in FIG. 4B. In other words, the region with the layers removed in FIG. 4A is not intended to be the actual structure of the support sleeve 52 and is instead shown for a clearer illustration of the internal components of the support sleeve 52.

[0028] Similar to the support sleeve 10, the support sleeve 52 also includes a tubular sleeve portion 56 and an inflation tube 58 in fluid communication with a support balloon 60. The tubular sleeve portion 56 is sized (or otherwise dimensioned) to be inserted into any number of vascular structures in the patient (e.g., veins, arteries, etc.). The tubular sleeve portion 56 has a proximal end 62, an opposite distal end 64, and a hole through them (e.g., extending along the axial direction). As shown, the distal end 64 of the tubular sleeve portion 52 has an arched (or conical) shape as the distal end 64 of the tubular sleeve portion 56 extends more distally. In some embodiments, the cross-sectional area of ​​the Petition 870210107021, dated 11 / 19 / 2021, page 12 / 33 / 21. The distal end 64 may (gradually) decrease in size as the distal end 64 of the tubular glove portion 56 extends more distally. This gradual decrease in cross-sectional area may more easily allow the tubular glove portion 56 to be traversed through the patient's vascular structure. The support balloon 60 is attached to an outer surface of the distal end 64 of the tubular glove portion 56 and may be selectively inflated to firmly hold and support the support glove 52 in a particular location within the patient's vasculature. Similar to the support balloon 16, the support balloon 60 may extend around the entire circumference of a portion of the outer surface of the tubular glove portion 56.However, in alternative embodiments, the support balloon 60 may extend along only a portion of the circumference of the outer surface of the tubular sleeve portion 56 (for example, from and to opposite ends of the circumference, such as 180°). In other cases, the support balloon may have two independently inflatable portions positioned on opposite sides of the tubular sleeve portion and interfacing with the respective inflation tubes.

[0029] The support sleeve 52 also includes an inner lining 66 that is coupled to the inner surface of the tubular sleeve portion 56. The inner lining 66 may be relatively thin and formed from a flexible material (e.g., polytetrafluoroethylene (“PTFE”)). As shown in FIG. 4, the inner lining 66 includes a braided filament 68 that provides flexibility and structurally reinforces the inner lining 66. The braided filament 68 may have individual filaments of a particular size and may be formed from various materials (e.g., metals, plastics, etc.). The braided filament 68 is illustrated as having four alternating filaments in a helical pattern that is approximately equidistant from the adjacent filaments; however, in alternative configurations, other numbers of filaments or different styles (or types) of braiding pattern may be used for the braided filament 68. In some Petition 870210107021, dated 11 / 19 / 2021, page 13 / 33 / 21 cases, the inner coating 66 can be sandwiched between the braided filament 68, while in other cases, the braided filament 68 can be coupled to a specific surface (e.g., the inner or outer surface) of the inner coating 66. In alternative configurations, the inner coating 66 can be removed and the braided filament can be coupled to the inner surface of the tubular sleeve portion 56. Thus, generally, the braided filament 68 is structured as having a tube shape, however, the overall shape of the braided filament 68 can be adjusted accordingly, based, for example, on the desired flexibility of the support sleeve 52 (e.g., the braided filament can incorporate different shapes, such as a rectangular prism and an octagonal prism, etc.).

[0030] The support sleeve 52 also includes a coupling portion that selectively allows or restricts the advancement of the balloon catheter 54 with or without the support sleeve 52. In other words, the coupling portion 70 allows the balloon catheter 54 to be removablely coupled to the support sleeve 52, so that when the balloon catheter 54 is advanced into the patient's vasculature, the balloon catheter 54 can be advanced with the support sleeve 52 (when coupled), or alternatively, advanced alone (when the balloon catheter 54 is uncoupled from the support sleeve 52). In the embodiment illustrated in FIG. 4, the coupling portion 70 is implemented as a balloon 72 in fluid communication with an inflation tube 74. The balloon 72 is coupled to the inner sheath 66 (e.g., the inner surface) and allows the support sleeve 52 to be removablely coupled to the balloon catheter 54.For example, when balloon 72 is inflated, a surface of balloon 72 contacts balloon catheter 54 so as to couple the support sleeve 52 to balloon catheter 54. In this way, the support sleeve 52 and balloon catheter 54 advance together along the patient's vasculature. In other words, the relative movement between the support sleeve 52 and balloon catheter 54 is restricted. Alternatively, when balloon 72 is deflated (for example, upon reaching a narrowed vessel or... Petition 870210107021, dated 11 / 19 / 2021, page 14 / 33 / 21 calcified), the surface of balloon 72 is retracted (entirely or partially) away from the balloon catheter 54, thus allowing the balloon catheter 54 to move freely away from the support sleeve 52. In other words, relative movement between the balloon catheter 54 and the support sleeve 52 is permitted. In some cases, balloon 72 (or other coupling portion 70, such as those described below) can adjust the force (or effort) required by the physician to advance the balloon catheter 54 relative to the support sleeve 52. For example, different levels of deflation (or inflation) (e.g., pressure, fluid volume, etc.) can adjust the amount of friction between balloon 72 and balloon catheter 54, which impacts the ease or difficulty (e.g., the force) required to move the balloon catheter 54 relative to balloon 72.In other words, balloon 72 (or other coupling portion 70) can adjust a degree of coupling between balloon 72 (or usually the support sleeve 52) and balloon catheter 54.

[0031] Although the inflation tube 58 is generally coupled to and extends along the tubular sleeve portion 56. However, in alternative embodiments, the inflation tube 58 may be directed to the tubular sleeve portion 56 (or additionally other layers, such as the inner lining 66) to extend along different components to reach the proximal end of the support sleeve 52 (e.g., extending along the inner surface of the tubular sleeve portion 56, extending along the inner surface of the inner lining 66, etc.).

[0032] FIG. 5 shows a cross-sectional side view of another system 100 for enlarging a passage within a patient's body, which is similar to the previously described systems 20, 50. Thus, the previous description of systems 20, 50 also refers to system 100. System 100 also includes a support sleeve 102 and a balloon catheter 104. The support sleeve 102 includes a tubular sleeve portion 106 and an inflation tube 108 in fluid communication with a support balloon 110. The tubular sleeve portion Petition 870210107021, dated 11 / 19 / 2021, page 15 / 33 / 21 106 is designed to be inserted into any number of vascular structures in the patient. In some embodiments, the tubular glove portion 106 is a hypotube. The tubular glove portion 56 has a proximal end 112, an opposite distal end 114, and a hole through them. As shown, the support balloon 110 is attached to an outer surface of the tubular glove portion 106 and is positioned between the ends 112, 114 of the tubular glove portion 56. In particular, the tubular glove portion has protrusions 116 that extend radially outward from the outer surface of the tubular glove portion 106, and the support balloon 110 can be positioned between the adjacent protrusions 116.In some cases, the protrusions 116 may be formed from a material that has a lower coefficient of sliding friction (and coefficient of static friction) than that of the tubular sleeve portion 106, which may allow the support sleeve 102 to slide easily through the vascular structure being traversed (e.g., via the protrusions 116). In some embodiments, a given protrusion 116 may extend around the entire circumference (or portions) of the circumference of the tubular sleeve portion 106. Additionally, adjacent protrusions 116 may be separated from each other by the same distances, or the separation distances may vary (e.g., along the axial direction of the tubular sleeve portion). The protrusions 116 are illustrated as being substantially flat (e.g., having a plateau), although in alternative embodiments, other shapes may be used (e.g., hemispheres), based on the desired degree of sliding.

[0033] As described above, sets of adjacent protrusions 116 can receive a support balloon (e.g., support balloon 110). This can be advantageous because the physician can specifically adjust the anchoring capacity by selecting the number or size of the support balloons 110, based on the patient's anatomy, the type of vascular structure, the anatomical location, etc. The support balloon(s) 110 can be inflated Petition 870210107021, dated 11 / 19 / 2021, p. 16 / 33 / 21 selectively to firmly hold (or otherwise anchor) the support sleeve 102 in a particular location within the patient's vasculature. In some embodiments, a given balloon 110 and adjacent protrusions 116 may have various axial lengths 118. In some specific configurations, the axial length 118 may be less than 20 mm, less than 10 mm, in a range between 5 mm and 15 mm, etc. In some embodiments, the protrusions 116 may extend away from the outer surface of the tubular sleeve portion 106 by a height that does not significantly increase the outer diameter of the support sleeve 102. As shown, the support balloon 110 in an inflated state has a height greater than the height of the protrusions 116, and that height may be in a range of 5 mm to 25 mm.In some cases, the height difference between the inflated balloon 110 and the protrusions 116 may be about 1 mm (for example, the height of the inflated balloon 110 being 5 mm). In some embodiments, the axial length of the protrusions 116 may be less than or equal to 20 mm. In some embodiments, the balloon(s) 110 may be formed from various materials, such as, for example, polyurethane, pebax®, silicon, etc.

[0034] As shown, the support sleeve 102 also includes an inner lining 120 having a thickness and which is coupled to the inner surface of the tubular sleeve portion 106. The inner lining 120 may be relatively thin and formed of a flexible material (e.g., polytetrafluoroethylene (“PTFE”)). As also shown in FIG. 5, the inner lining 120 includes a braided filament 122 which provides flexibility and structurally reinforces the inner lining 120. The braided filament 122 may have individual filaments of a particular size and may be formed of various materials (e.g., metals, plastics, etc.). The braided filament 122 is illustrated as having a hatched pattern; however, in alternative configurations, other numbers of filaments or different styles (or types) of the braided pattern may be used for the Petition 870210107021, dated 11 / 19 / 2021, page. 17 / 33 / 21 braided filament 122. In some cases, the inner coating 120 may be sandwiched between the braided filament 122, while in other cases, the braided filament 122 may be coupled to a specific surface (e.g., the inner or outer surface) of the inner coating 120. In alternative configurations, the inner coating 120 may be removed and the braided filament may be coupled to the inner surface of the tubular sleeve portion 106. Thus, generally, the braided filament 122 is structured as having a tube shape; however, the overall shape of the braided filament 122 may be adjusted accordingly, based on, for example, the desired flexibility of the support sleeve 102 (e.g., the braided filament may incorporate different shapes, such as a rectangular prism and an octagonal prism, etc.).As also shown, the inner coating 120 (and the braided filament 122) extends only along a portion of the tubular sleeve portion 106. In some specific examples, the inner coating (and the braided filament 122) has an axial length in a range between 30 mm and 120 mm.

[0035] The support sleeve 102 also includes a coupling portion 124 that selectively allows or restricts the advancement of the balloon catheter 104 with or without the support sleeve 102. In other words, the coupling portion 124 allows the balloon catheter 104 to be removablely coupled to the support sleeve 102, so that when the balloon catheter 104 is advanced into the patient's vasculature, the balloon catheter 104 can be advanced with the support sleeve 102 (when coupled), or alternatively, advanced alone (when the balloon catheter 104 is uncoupled from the support sleeve 102). In the embodiment illustrated in FIG. 5, the coupling portion 124 is implemented as a fastening wire 126. The fastening wire 126 can be structured as a typical wire made of metal (e.g., a stainless steel wire) and be cable-like, and in other cases, the fastening wire 126 can incorporate various other shapes, forms, etc. Thus, the wire Petition 870210107021, dated 11 / 19 / 2021, page 18 / 33 / 21. The fixation wire 126 does not need to be merely long and thin; instead, the fixation wire 126 may be plate-like, etc. In some embodiments, a portion (or all) of the fixation wire 126 may be encapsulated (or arranged on a surface) with a coating layer that may have a higher coefficient of sliding (and static) friction than the fixation wire 126 itself. This coating may thus provide varying levels of resistance to the movement of the balloon catheter 104 relative to the fixation wire 126. In some embodiments, the coating may also prevent the edges (or ends) of the fixation wire 126 from undesirably puncturing system components 100.

[0036] The 126 fastening wire generally allows the support sleeve 102 is removablely coupled to the balloon catheter 104. For example, when the fixation wire 126 is inserted into the tubular sleeve portion 106, the fixation wire 126 contacts (or is wedged between) the balloon catheter 104 and the inner sheath 120 (or the braided filament 122) to temporarily couple the balloon catheter 104 to the inner sheath 120 of the support sleeve 102 (e.g., via the fixation wire 126). The contact of the fixation wire 126 allows the balloon catheter 104 and the support sleeve 102 to be advanced together along the patient's vasculature. In other words, relative movement between the balloon catheter 104 and the support sleeve 102 is prevented. Alternatively, when the fixation wire 126 is removed (e.g., pulled out of contact with the balloon catheter 104 and the inner sheath 120), the balloon catheter 104 is free to move (or translate) away from the support sleeve 102.Thus, relative movement between the balloon catheter 104 and the support sleeve 102 is permitted. Similar to balloon 72 above, the fixation wire 126 can be advanced (or retracted) to increase (or decrease) the force required to advance the balloon catheter 104 relative to the support sleeve 102. For example, as the fixation wire 126 is advanced further relative to the proximal end of the support sleeve 102, more surface area of ​​the fixation wire 126 is gained. Petition 870210107021, dated 11 / 19 / 2021, page 19 / 33 / 21 contacts the balloon catheter 104 (and the inner sheath 120) and thus increases the force required to create relative movement between the fixation wire 126 and the balloon catheter 104. Similarly, as the fixation wire 126 is pulled back closer to the proximal end of the support sleeve 102, less surface area of ​​the fixation wire 126 comes into contact with the balloon catheter 104 (and the inner sheath 120) and thus decreases the force required to create relative movement between the fixation wire 126 and the balloon catheter 104.

[0037] As shown, the inflation tube 108 is generally coupled to and extends along the tubular sleeve portion 106 (e.g., to reach the balloon 110). However, in alternative embodiments, the inflation tube 108 may be directed to the tubular sleeve portion 106 (or additionally other layers, such as the inner lining 120) to extend from the balloon 110 and along different components to reach the proximal end of the support sleeve 102 (e.g., extending along the inner surface of the tubular sleeve portion 106, extending along the inner surface of the inner lining 120, etc.). In some embodiments, the inflation tube 108 may be formed of polyimide.

[0038] In some embodiments, and as illustrated, the support sleeve 102 also includes a port adapter 128 and a double port attachment 130. The port adapter 128 can be coupled to the tubular sleeve portion 106, although in the embodiment illustrated in FIG. 5 the port adapter 128 is separate from the tubular sleeve portion 106. As shown, a proximal end of the port attachment 128 is coupled (e.g., by threaded coupling, adhesive, etc.) to a first end of the double port attachment 130, while the distal end of the attachment port 128 is tapered (e.g., along an axial direction towards the distal end). The opposite second end of the double port attachment 130 includes two distinct ports that eventually converge to the single defined orifice. Petition 870210107021, dated 11 / 19 / 2021, page 20 / 33 / 21, for port adapter 128. In some specific implementations, the double port accessory 130 is a luer y. As illustrated in FIG. 5, the two-port configuration allows one port to independently receive the fastening wire 124, while the second port (e.g., coaxially positioned to the port adapter hole 128) independently receives the inflation tube 108 (e.g., to eventually connect to a fluid source). In this case, as described above, the fastening wire 124 can be more easily manipulated in its own independent port. Additionally, as in the illustrated embodiment, the inflation tube 108 is coupled to the port adapter 128.

[0039] FIG. Figure 6 shows a cross-sectional side view of another system 200 for enlarging a passage within a patient's body, which is similar to the previously described systems 20, 50, and 100. Thus, the previous description of systems 20, 50, and 100 also applies to system 200. System 200 also includes a support sleeve 202 and a balloon catheter 204. The support sleeve 202 includes a first tubular sleeve portion 206, a second tubular sleeve portion 208, and an inflation tube 210 communicating with a support balloon 212. The first tubular portion 206 is structured similarly to the tubular portion 106. For example, the first tubular portion 206 also includes protrusions 214, and the support balloon 212 is coupled to the outer surface of the first tubular portion 206 between the adjacent protrusions 214. As also previously described, the first portion Tubular 206 can also include an inner lining with a braided filament.

[0040] The second tubular portion 208 is illustrated as having a hole directed through it. In some embodiments, the second tubular portion 208 is a hypotube. In some embodiments, a portion of the second tubular portion 208 may be coupled to the first tubular portion 206. In this case, the first and second tubular portions 206, 208 would still be separated by a distance (or opening) to receive the catheter. Petition 870210107021, dated 11 / 19 / 2021, page. 21 / 33 / 21 balloon 204. As shown, the inflation tube 210 is coupled to and extends along the outer surface of the first tubular portion 206, extends through (and may be coupled to an inner surface of) the second tubular portion 208, extends into (or externally to) a cable 216 of the support sleeve 102, and is inserted into a port adapter 218 of the support sleeve 102. The port adapter 218 is configured to receive a fluid infusion device (e.g., a syringe), and since the fluid infusion device interfaces with the port adapter 218, the fluid infusion device is also in fluid communication with the inflation tube 210. In this way, the fluid infusion device can deliver fluid to the support balloon 212 through the inflation tube 210.

[0041] As shown, the support sleeve 202 also includes a coupling portion 220 that selectively allows or restricts the advancement of the balloon catheter 204 with or without the support sleeve 202. In other words, the coupling portion 220 allows the balloon catheter 204 to be removablely coupled to the support sleeve 202, so that when the balloon catheter 204 is advanced into the patient's vasculature, the balloon catheter 204 can be advanced with the support sleeve 202 (when coupled), or alternatively, advanced alone (when the balloon catheter 204 is uncoupled from the support sleeve 202). In the embodiment illustrated in FIG. 6, the coupling portion 220 is implemented as being a wire 222 (or other mooring structure) interfacing with a winch 224. The winch 224 is illustrated as having a rotating cable that interfaces with gears, other rotating components, such as a shaft, etc., to pull inward (or outward, so as to provide slack) one end of wire 222, while the other end of wire 222 may be attached to a portion of the winch 224 (for example, the rotating shaft of the winch) or other structure. Wire 222 may be of an appropriate size and may be made of various materials. For example, wire 222 may be formed of a superelastic metal (for example, nitinol) and may be... Petition 870210107021, dated 11 / 19 / 2021, page 22 / 33 / 21 made to have a thickness being, for example, 0.004 inches, 0.0006 inches, etc. In some cases, 222 wire may be rounded (e.g., edge-free) and in other cases, 222 wire may be made of other materials, such as plastics.

[0042] The wire 222 (and the winch 224) generally allows the support sleeve 202 to be removablely coupled to the balloon catheter 204. For example, as shown, the wire 222 is hoisted around the balloon catheter 204, and therefore, when the wire 222 is tightened (e.g., by tightening with the winch 224), the loop of the wire 222 becomes smaller and increases the contact between the wire 222 and the balloon catheter 204. As such, this tightening of the wire 222 temporarily couples the balloon catheter 204 to the wire 222. This restraint by the wire 222 allows the balloon catheter 204 and the support sleeve 202 to be advanced together along the patient's vasculature. In other words, the relative movement between the balloon catheter 204 and the support sleeve 202 is prevented. Alternatively, when wire 222 is loosened (for example, by rotating winch 224 in the opposite direction), the loop of wire 222 increases in size and decreases the contact between wire 222 and balloon catheter 204.As such, loosening of the wire 222 temporarily disengages the balloon catheter 204 from the wire. This loosening allows the balloon catheter 204 to turn freely relative to the support sleeve 202. Similarly, for the other systems described above, a degree of tightness (or slack) of the wire 222 loop can increase (or decrease) the force required to advance the balloon catheter 204.

[0043] FIG. 7 shows a flowchart of a 300 process for widening a narrowed blood vessel. In some embodiments, the 300 process may utilize a guidewire, a balloon catheter having a distal and a proximal end, a support sleeve having a support balloon, and other components. In 302, the 300 process includes the placement and feeding of a guidewire and a balloon catheter into the patient's vascular system. For example, a physician may feed and place the guidewire, followed by Petition 870210107021, 11 / 19 / 2021, p. 23 / 33 / 21 feeding and placement of the balloon catheter to the narrowed blood vessel segment. If the balloon catheter can be advanced to the site to widen the narrowed segment, the physician may do so and complete the procedure. If the balloon catheter cannot be advanced through the narrowed segment, the balloon catheter may be retracted back out of the patient. In some forms, the physician does not need to test for a problem with balloon catheter advancement but may begin the procedure with the support sleeve attached to the balloon catheter.

[0044] In 304, process 300 includes sliding the support sleeve over the balloon catheter. For example, the support sleeve may be slid over the distal end of the balloon catheter and advanced to a desired position. In 306, process 300 includes temporarily attaching the balloon catheter to the support sleeve.For example, the balloon can be temporarily attached to the balloon catheter between a balloon catheter enlargement balloon and the proximal end.

[0045] In 308, process 300 includes advancing the support sleeve and balloon catheter together over the guidewire. For example, once the balloon catheter is temporarily attached to the support sleeve, the balloon catheter and support sleeve can be advanced together through the patient's circulatory system until the narrowed vessel segment is reached.

[0046] In 310, process 300 includes detaching the support sleeve from the balloon catheter when the balloon catheter reaches the narrowed blood vessels. In some cases, the physician may determine visually (e.g., on a medical image of the procedure), or may determine by a tactile sense (e.g., by resistance or difficulty in advancing the balloon catheter with the support sleeve) that the balloon catheter has reached the narrowed blood vessel. Regardless, the balloon catheter may be detached from the support sleeve to allow the balloon catheter to translate (or move) relative to the support sleeve.

[0047] In 312, process 300 includes inflating the balloon of the support sleeve. After the balloon catheter is detached from the support sleeve, the balloon of Petition 870210107021, dated 11 / 19 / 2021, page 24 / 33 / 21 support can be inflated to make contact and thus anchor the support sleeve in a location within the blood vessel.

[0048] In 314, process 300 includes advancing the balloon catheter into the narrowed blood vessel. For example, after the support sleeve is properly positioned and secured (e.g., anchored by inflation of the support balloon), the balloon catheter can be advanced into the narrowed blood vessel segment and positioned accordingly. For example, the enlargement balloon of the balloon catheter can be positioned entirely within the narrowed portion of the vessel that is to be expanded. In some cases, the use of the support sleeve may allow the balloon catheter to advance beyond a first narrowed portion of the patient's vasculature, but a second narrowed portion may be encountered before the balloon catheter reaches the desired segment. In such cases, the balloon of the support sleeve can be deflated and the support sleeve advanced over the balloon catheter into the second narrowed portion.The support sleeve can then be reimplanted by inflating the support sleeve balloon in this second, more distal, narrowed portion of the patient's vasculature. This process can be repeated several times, if necessary, to reach the desired segment in the patient's vasculature.

[0049] In 316, process 300 includes inflating the balloon catheter. For example, after the balloon catheter has been successfully advanced (and positioned accordingly), the balloon catheter is inflated to widen the narrowed segment of the vessel to be expanded. If necessary, a stent can also be placed through the balloon catheter as the enlargement balloon expands.

[0050] In 318, process 300 may include deflating the balloon catheter and retracting the balloon catheter from the narrowed (and now expanded) blood vessel. For example, when sufficient inflation of the enlargement balloon and widening of the vessel occur, or if for any other reason the balloon catheter needs to be removed from the patient, the enlargement balloon may be deflated and the balloon catheter may be retracted. Petition 870210107021, dated 11 / 19 / 2021, page 25 / 33 / 21

[0051] In 320, process 300 may include deflating the support balloon, (temporarily) attaching the support sleeve to the balloon catheter, and retracting the balloon catheter with the support sleeve from the patient. For example, once the balloon catheter is retracted to an appropriate position, the balloon catheter may be attached to the support sleeve (with the support balloon inflated). Then, the support balloon may be deflated, and the balloon catheter and support sleeve may be retracted together from the patient. While this description has established specific ways of performing a method of widening a narrowed blood vessel, it should be noted that a number of these steps may occur in a different order than described.

[0052] The present disclosure has described one or more preferred embodiments and it should be appreciated that many equivalents, alternatives, variations and modifications, in addition to those expressly stated, are possible and within the scope of the invention. Petition 870210107021, dated 11 / 19 / 2021, pp. 26 / 33

Claims

1 / 3 CLAIMS 1. Support sleeve (10, 52, 102, 202) for use with a balloon catheter (24, 54, 104, 204), characterized in that it comprises: a sleeve portion (14, 56, 106, 206, 208), in tubular form, and having an internal diameter of a size and shape to receive a balloon catheter (24, 54, 104, 204); a support balloon (16, 60, 110, 212) coupled to an external surface of the sleeve portion (14, 56, 106, 206, 208);and an inflation tube (12, 58, 74, 108, 210) in fluidic communication with the support balloon (16, 60, 110, 212), wherein the inflation tube (12, 58, 74, 108, 210) allows a fluid to be supplied to the support balloon (16, 60, 110, 212) in order to inflate the support balloon (16, 60, 110, 212) wherein the support sleeve (10, 52, 102, 202) further comprises a coupling portion (70, 124, 220) that provides selective coupling of the support sleeve (10, 52, 102, 202) to a balloon catheter (24, 54, 104, 204) disposed within the inner diameter of the sleeve portion. (14, 56, 106, 206, 208); and wherein the coupling portion (70, 124, 220) is a wire configured to contact the balloon catheter (24, 54, 104, 204) and an inner surface of the sleeve portion (14, 56, 106, 206, 208) to restrict the relative movement between the balloon catheter (24, 54, 104, 204) and the support sleeve (10, 52, 102, 202).

2. Support sleeve, according to claim 1, characterized in that the wire is a flat wire having a width greater than its height.

3. Support sleeve, according to claim 1 or 2, characterized in that the wire is coated with a coating layer having a coefficient of friction sufficient to restrict the relative movement between the balloon catheter (24, 54, 104, 204) and the support sleeve Petition 870250111424, dated 04 / 12 / 2025, page 8 / 13 2 / 3 (10, 52, 102, 202).

4. Support sleeve, according to any one of claims 1 to 3, characterized in that the coupling portion (70, 124, 220) is a wire and a winch, the wire having a loop for receiving the balloon catheter (24, 54, 104, 204), and in that the winch is operable to tighten or loosen the wire loop to selectively restrict or permit relative movement between the balloon catheter (24, 54, 104, 204) and the support sleeve (10, 52, 102, 202).

5. Support sleeve, according to any one of claims 1 to 4, characterized in that it further comprises: a crank positioned at a proximal location relative to the sleeve portion (14, 56, 106, 206, 208), wherein the winch is coupled to the crank; and a hypotube extending from the crank to a position adjacent to a proximal end of the sleeve portion (14, 56, 106, 206, 208), wherein the wire and inflation tube (12, 58, 74, 108, 210) are disposed within the hypotube.

6. Support sleeve, according to any one of claims 1 to 5, characterized in that the support balloon (16, 60, 110, 212) is configured to be inflated to a diameter approximately equal to the diameter of a blood vessel adjacent to a narrowed blood vessel segment within a patient.

7. Support sleeve, according to any one of claims 1 to 6, characterized in that the support balloon (16, 60, 110, 212) comprises: a first support balloon and a second support balloon, wherein the first support balloon is positioned to inflate outward from the outer surface of the sleeve portion (14, 56, 106, 206, 208) and the second support balloon is positioned to inflate inward from an inner surface of the sleeve portion (14, 56, 106, 206, 208).

8. Support sleeve, according to any one of claims 1 to 7, characterized in that the inflation tube (12, 58, 74, 108, 210) is a hypo-tube.

9. Support sleeve, according to any one of claims 1 to 8, characterized in that the support sleeve (10, 52, 102, 202) comprises a flexible tube having a braided filament attached to an inner surface of the flexible tube.

10. Support sleeve, according to any one of claims 1 to 9, characterized in that the sleeve portion (14, 56, 106, 206, 208) has a length between 30 mm and 120 mm.

11. Support sleeve, according to any one of claims 1 to 10, characterized in that the support balloon (16, 60, 110, 212) has an axial length between 5 mm and 20 mm. Petition 870250111424, dated 04 / 12 / 2025, page 10 / 13

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