Patent Publication Number: US-2022226620-A1

Title: Systems and methods for a balloon catheter support sleeve

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     The present application is based on and claims priority to U.S. Provisional Patent Application No. 62/841,997, filed May 2, 2019, and entitled “Balloon Catheter Support Sleeve,” which is hereby incorporated by reference herein in its entirety for all purposes. 
    
    
     BACKGROUND 
     Within the human body, blood vessels can become narrowed. Arteries, for example, can become narrowed in discrete 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 coupled to the balloon for delivery, is fed through the circulatory system to the narrowed vessel and inflated. In some instances, 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 to no physical support to assist in urging it through the narrowed vessel. 
     Prior to inserting the balloon catheter, physicians will sometimes use a guideline extension device, which defines a hollow flexible tube, into the circulatory system. The guideline extension device can be fed through the vasculature of the patient until it is seated near the narrowed vessel segment. This device can provide support to a balloon catheter that is fed through the hollow channel of the guideline extension device. However, some guideline extension devices are very difficult to advance in certain types of coronary anatomy, cannot supply adequate support, back-out as the balloon catheter is attempted to advance, risk dissection when contrast injection is performed because the guideline extension device is inside the artery, and are typically very expensive. 
     SUMMARY OF THE DISCLOSURE 
     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 internal diameter of a size and shape to receive a balloon catheter. The support balloon is coupled 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 to inflate the support balloon, and the support sleeve being removably coupled to the balloon catheter. 
     In some embodiments, the support sleeve further includes a coupling portion that selectively couples the support sleeve to the balloon catheter. 
     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. 
     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 loop of the wire to selectively restrict or allow relative movement between the balloon catheter and the support sleeve. 
     In some embodiments, the support balloon is configured to be inflated to a diameter about equal to a diameter of a blood vessel adjacent to a narrowed blood vessel segment within a patient. 
     In some embodiments, the support balloon 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 and the second support balloon is positioned to inflate inward from an inner surface of the sleeve portion. 
     In some embodiments, the inflation tube is a hypo-tube 
     The foregoing 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 that form a part hereof, and in which there is shown by way of illustration a preferred embodiment. This embodiment does not necessarily represent the full scope of the invention, however, and reference is therefore made to the claims and herein for interpreting the scope of the invention. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  shows a support sleeve according to an embodiment. 
         FIG. 2  shows a system for enlarging a narrow passage within the body of a patient according to an embodiment. 
         FIG. 3  shows the system of  FIG. 2  having an inflated support balloon. 
         FIG. 4A  shows a partial view of a support sleeve according to an embodiment. 
         FIG. 4B  shows a cross section through the partial view of the support sleeve shown in  FIG. 4A . 
         FIG. 5  shows a cross-sectional side view of a system for enlarging a blood vessel. 
         FIG. 6  shows a cross-sectional side view of another system for enlarging a blood vessel. 
         FIG. 7  shows a flow chart of a process for widening a narrowed blood vessel according to an embodiment. 
     
    
    
     DETAILED DESCRIPTION 
     Described here are systems and methods for widening a narrowed blood vessel within a patient. Embodiments described in the present disclosure facilitate angioplasty balloon catheter and stent catheter advancement, which in some instances may be after the lesion has been crossed with a guidewire, in arteries that are tortuous and/or calcified. In many cases, advancing balloon catheters can be challenging due to inadequate guider support. When the balloon catheter meets resistance, the guiding catheter can be pushed out of the coronary artery ostium and the balloon catheter cannot progress. 
     Referring first to  FIG. 1 , a support sleeve  10  according to an 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  such 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 a vessel lumen. 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 another 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 hypo-tube or any small tube having a diameter that allows the inflation tube  12  to be fed through the vascular system of a patient. 
     The support balloon  16  can be composed of a compliant material such that the support balloon  16  can reach its fully-inflated diameter with very little pressure applied by the syringe. In one non-limiting example, in the fully-inflated state, the support balloon  16  expands to a spherical shape having a diameter about equal to the diameter of the artery where the support sleeve  10  will placed during a blood vessel widening procedure. The extent of the inflation of support balloon  16  will depend on the fluid pressure applied via the syringe. In other configurations, the support balloon  16  can have different shapes or geometries. After inflation, the support balloon  16  firmly holds the support sleeve  10  in place within the blood vessel and can act as 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 sleeve portion  14 , however in alternative configurations, the balloon  16  can extend along a portion of the circumference of the sleeve portion  14  (e.g., an arc length of the circumference of the sleeve portion  14 ). 
     In some forms, the support sleeve  10  can include multiple support balloons  16 . In these instances, some support balloons  16  can 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&#39;s blood vessel. This configuration prevents the support sleeve  10  from backing away from the narrowed blood vessel segment. Some support balloons  16  can be positioned to expand inward from the inner surface of the tubular sleeve portion  14  to contact a guidewire  22  ( FIGS. 2-3 ) extending through the tubular sleeve portion  14 . This configuration helps to prevent backing out of the balloon catheter  24  during and after advancement of the balloon catheter  24  into the narrowed blood vessel segment. The support sleeve  10  can have any combination of support balloon  16  configurations, such as two support balloons expanding outward, two support balloons expanding inward, one support balloon expanding inward and one expanding outward, and so on. 
     Referring next to  FIGS. 2 and 3 , a system  20  for enlarging a narrow passage within the body of a patient is shown. The system  20  includes a guidewire  22 , a balloon catheter  24  having an enlarging balloon  26 , and the support sleeve  10 . The balloon catheter  24  is advanced over the guide wire  22 , and the support sleeve  10  has an internal diameter of a size and shape to receive the balloon catheter  24  in its deflated state. In use, the balloon catheter  24  and the guide wire  22  extend through the tubular sleeve portion  14 . Thus, when the support sleeve  10  is placed for vessel widening, the inflation tube  12  and the guide wire  22  extend in parallel back through the circulatory system to the entrance of system  20  into the body. 
     In some forms, the support sleeve  10  includes a coupling portion and/or the balloon catheter  24  includes a coupling portion. The coupling portions can 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 can be additional balloons or a double walled balloon, the expansion of which can hold the support sleeve  10  and the balloon catheter  24  together frictionally. Further, the mechanical coupling can include other frictional mechanisms, scaffolding, or a hook and loop structure that provide selective coupling and decoupling. Balloon catheter  24  has a distal end  28  and a proximal end  30 , the distal end  28  being the leading tip of the balloon catheter  24  and the proximal end  30  being located adjacent to a guidewire export port of the balloon catheter  24 . 
     The coupling portions described above selectively couple the support sleeve  10  and the balloon catheter  24  such that the support sleeve  10  is positioned proximal to the enlarging balloon  26  of balloon catheter  24 , but distal to the guidewire export port. In some other instances, the support sleeve  10  can be coupled at the distal end of the balloon catheter  24 , such that the support sleeve  10  is the leading edge of the combined device that is introduced into the patient&#39;s vasculature. The support sleeve  10  can be selectively coupled and decoupled from the balloon catheter  24  so that the support sleeve  10  and balloon catheter  24  can be advanced together through the vasculature of the patient, 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. 
       FIG. 4A  shows a top view of another system  50  for enlarging a passage within the body of a patient, which is a specific implementation of the system  20 . Thus, the previous description of the system  20  also pertains to the system  50 . The 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, layers (or components) of the support sleeve are generally intended to be coaxially disposed relative 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 rather is shown for clearer illustration of the internal components of the support sleeve  52 . 
     Similarly 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 inside 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 bore therethrough (e.g., extending along the axial direction). As shown, the distal end  64  of the tubular sleeve portion  52  has an arcuate (or tapered) shape as the distal end  64  of the tubular sleeve portion  56  extends farther distally. In some embodiments, the cross-sectional area of the distal end  64  can (gradually) decrease at the distal end  64  of the tubular sleeve portion  56  extends farther distally. This gradual decreasing in cross-sectional area may more easily allow the tubular sleeve portion  56  to be traversed through the vascular structure of the patient. The support balloon  60  is coupled to an exterior surface of the distal end  64  of the tubular sleeve portion  56 , and can be selectively inflated to firmly hold and support the support sleeve  52  at a particular location within the vasculature of the patient. Similarly to the support balloon  16 , the support balloon  60  can extend around the entire circumference of a portion of the exterior surface of the tubular sleeve portion  56 . However, in alterative embodiments, the support balloon  60  can extend along only a portion of the circumference of the exterior surface of the tubular sleeve portion  56  (e.g., from and to opposing ends of the circumference, such as 180°). In other cases, the support balloon can have two independently inflatable portions positioned on opposing sides of the tubular sleeve portion and interfaced with respective inflation tubes. 
     The support sleeve  52  also includes a liner  66  that is coupled to the interior surface of the tubular sleeve portion  56 . The liner  66  can be relatively thin and formed out of a flexible material (e.g., polytetrafluoroethylene (“PTFE”)). As shown in  FIG. 4A , the liner  66  includes a braided filament  68  that provides flexibility and structurally reinforces the liner  66 . The braided filament  68  can have individual filaments of a particular size and can be formed out of various materials (e.g., metals, plastics, etc.). The braided filament  68  is illustrated as having four alternating filaments in a helical pattern that is roughly equidistant to adjacent filaments, however in alternative configurations, other numbers of filaments or different styles (or types) of the braiding pattern can be used for the braided filament  68 . In some cases, the liner  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 interior or exterior surface) of the liner  66 . In alternative configurations, the liner  66  can be removed and the braided filament can be coupled to the interior 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 on, for example, the desired flexibility of the support sleeve  52  (e.g., the braided filament can embody different shapes, such as a rectangular prism, and octagonal prim, etc.). 
     The support sleeve  52  also includes a coupling portion  70  that selectively allows or restricts 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 removably coupled to the support sleeve  52 , such that when the balloon catheter  54  is advanced into the vasculature of the patient, the balloon catheter  54  can be advanced with the support sleeve  52  (when coupled), or alternatively, advanced alone (when the balloon catheter  54  is decoupled from the support sleeve  52 ). In the illustrated embodiment of  FIGS. 4A and 4B , the coupling portion  70  is implemented as being a balloon  72  in fluid communication with an inflation tube  74 . The balloon  72  is coupled to the liner  66  (e.g., the interior surface) and allows the support sleeve  52  to be removably coupled to the balloon catheter  54 . For example, when the balloon  72  is inflated, a surface of the balloon  72  contacts the balloon catheter  54  so as to couple the support sleeve  52  to the balloon catheter  54 . This way, the support sleeve  52  and the balloon catheter  54  are advanced together along the vasculature of the patient. In other words, relative movement between the support sleeve  52  and the balloon catheter  54  is restricted. Alternatively, when the balloon  72  is deflated (e.g., when reaching a narrowed or calcified vessel), the surface of the balloon  72  is retracted (entirely or somewhat) away from the balloon catheter  54 , and thus allowing the balloon catheter  54  to freely move away from the support sleeve  52 . In other words, relative movement between the balloon catheter  54  and the support sleeve  52  is allowed. In some cases, the balloon  72  (or other coupling portion  70 , such as those described below) can adjust the force (or effort) required by the practitioner to advance the balloon catheter  54  relative to the support sleeve  52 . For example, different deflation (or inflation) levels (e.g., pressure, fluid volume, etc.) can adjust the amount of friction between the balloon  72  and the balloon catheter  54 , which impacts how easily or hard (e.g., the force) required to translate the balloon catheter  54  relative to the balloon  72 . In other words, the balloon  72  (or other coupling portion  70 ) can adjust a degree of coupling between the balloon  72  (or generally the support sleeve  52 ) and the balloon catheter  54 . 
     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  can be directed into the tubular sleeve portion  56  (or additionally other layers, such as the liner  66 ) to extend along different components to reach the proximal end of the support sleeve  52  (e.g., extend along the internal surface of the tubular sleeve portion  56 , extend along the interior surface of the liner  66 , etc.). 
       FIG. 5  shows a cross-sectional side view of another system  100  for enlarging a passage within the body of a patient, which is similar to the previously described systems  20 ,  50 . Thus, the previous description of the systems  20 ,  50  also pertain to the system  100 . The 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  106  is sized to be inserted inside any number of vascular structures in the patient. In some embodiments, the tubular sleeve portion  106  is a hypo-tube. The tubular sleeve portion  56  has a proximal end  112 , an opposite distal end  114 , and a bore therethrough. As shown, the support balloon  110  is coupled to an exterior surface of the tubular sleeve portion  106  and is positioned between the ends  112 ,  114  of the tubular sleeve portion  56 . In particular, the tubular sleeve portion has protrusions  116  that extend radially outward from the exterior surface of the tubular sleeve portion  106 , and the support balloon  110  can be positioned between adjacent protrusions  116 . In some cases, the protrusions  116  can be formed of a material that has a lower sliding coefficient of friction (and static coefficient of friction) than the tubular sleeve portion  106 , which can allow the support sleeve  102  to be easily slide across the vascular structure being traversed (e.g., via the protrusions  116 ). In some embodiments, a given protrusion  116  can extend around the entire circumference (or portions of) the circumference of the tubular sleeve portion  106 . Additionally, adjacent protrusions  116  can be separated from each other by the same distances, or the separation distances can 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 can be utilized (e.g., hemispheres), based on the desired degree of slidably. 
     As described above, sets of adjacent protrusions  116  can receive a support balloon (e.g., the support balloon  110 ). This can be advantageous in that the practitioner can specifically tailor the anchoring ability by selecting the number or size of support balloons  110 , based on the patient&#39;s anatomy, the type of vascular structure, the anatomical location, etc. The support balloon(s)  110  can be selectively inflated to firmly hold (or otherwise anchor) the support sleeve  102  at a particular location within the vasculature of the patient. In some embodiments, a given balloon  110  and the adjacent protrusions  116  can have various axial lengths  118 . In some specific configurations, the axial length  118  can 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  can extend away from the exterior 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 greater height than the height of the protrusions  116 , and which can 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  can be about 1 mm (e.g., the height of the inflated balloon  110  being 5 mm). In some embodiments, the axial length of the protrusions  116  can be less than or equal to 20 mm. In some embodiments, the balloon(s)  110  can be formed out of various materials, such as, for example, polyurethane, Pebax®, silicon, etc. 
     As shown, the support sleeve  102  also includes a liner  120  having a thickness, and which is coupled to the interior surface of the tubular sleeve portion  106 . The liner  120  can be relatively thin and formed out of a flexible material (e.g., polytetrafluoroethylene (“PTFE”)). As also shown in  FIG. 5 , the liner  120  includes a braided filament  122  that provides flexibility and structurally reinforces the liner  120 . The braided filament  122  can have individual filaments of a particular size and can be formed out of various materials (e.g., metals, plastics, etc.). The braided filament  122  is illustrated as having a crossed-hatched pattern, however in alternative configurations, other numbers of filaments or different styles (or types) of the braiding pattern can be used for the braided filament  122 . In some cases, the liner  120  can be sandwiched between the braided filament  122 , while in other cases, the braided filament  122  can be coupled to a specific surface (e.g., the interior or exterior surface) of the liner  120 . In alternative configurations, the liner  120  can be removed and the braided filament can be coupled to the interior 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  can be adjusted accordingly, based on, for example, the desired flexibility of the support sleeve  102  (e.g., the braided filament can embody different shapes, such as a rectangular prism, and octagonal prim, etc.). As also shown, the liner  120  (and the braided filament  122 ) only extend along a portion of the tubular sleeve portion  106 . In some specific examples, the linear (and the braided filament  122 ) have an axial length in a range between 30 mm and 120 mm. 
     The support sleeve  102  also includes a coupling portion  124  that selectively allows or restricts 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 removably coupled to the support sleeve  102 , such that when the balloon catheter  104  is advanced into the vasculature of the patient, the balloon catheter  104  can be advanced with the support sleeve  102  (when coupled), or alternatively, advanced alone (when the balloon catheter  104  is decoupled from the support sleeve  102 ). In the illustrated embodiment of  FIG. 5 , the coupling portion  124  is implemented as being a fixation wire  126 . The fixation wire  126  can be structured as being a typical wire formed of metal (e.g., a stainless steel wire) and being thread-like, and in other cases, the fixation wire  126  can embody various other forms, shapes, etc. Thus, the fixation wire  126  need not be only long and thin, and rather the fixation wire  126  can be plate-like, etc. In some embodiments, a portion (or all of) the fixation wire  126  can be encapsulated (or disposed on a surface) with a coating layer that can have a higher sliding (and static) coefficient of friction than the fixation wire  126  itself. This coating can thus provide varying levels of resistance to movement of the balloon catheter  104  relative to the fixation wire  126 . In some embodiments, the coating can also prevent edges (or ends) of the fixation wire  126  from undesirably puncturing components of the system  100 . 
     The fixation wire  126  generally allows the support sleeve  102  to be removably 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 liner  120  (or the braided filament  122 ) to temporarily couple the balloon catheter  104  to the liner  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 vasculature of the patient. Stated another way, 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 liner  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 allowed. Similarly to the balloon  72  above, the fixation wire  126  can be advanced (or retreated) 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 farther relative to the proximal end of the support sleeve  102 , more surface area of the fixation wire  126  contacts the balloon catheter  104  (and the liner  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 retreated closer to the proximal end of the support sleeve  102 , less surface area of the fixation wire  126  contacts the balloon catheter  104  (and the liner  120 ), and thus decreases the force required to create relative movement between the fixation wire  126  and the balloon catheter  104 . 
     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  can be directed into the tubular sleeve portion  106  (or additionally other layers, such as the liner  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 internal surface of the tubular sleeve portion  106 , extending along the interior surface of the liner  120 , etc.). In some embodiments, the inflation tube  108  can be formed out of polyimide. 
     In some embodiments, and as illustrated, the support sleeve  102  also includes a port adapter  128 , and a dual port attachment  130 . The port adapter  128  can be coupled to the tubular sleeve portion  106 , although in the illustrated embodiment of  FIG. 5  the port adapter  128  is separated from the tubular sleeve portion  106 . As shown, a proximal end of the port attachment  128  is coupled (e.g., by threaded engagement, adhesive, etc.) to a first end of the dual port attachment  130 , while the distal end of the port attachment  128  is tapered (e.g., along an axial direction towards the distal end). The opposing second end of the dual port attachment  130  includes two distinct ports that eventually converge to the single bore defined by the port adapter  128 . In some specific implementations, the dual port attachment  130  is a y-luer. As illustrated in  FIG. 5 , the two port configuration allows one port to independently receive the fixation wire  124 , while the second port (e.g., coaxially positioned to the bore of the port adapter  128 ) independently receives the inflation tube  108  (e.g., to eventually connect to a fluid source). In this case, as described above, the fixation 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 . 
       FIG. 6  shows a cross-sectional side view of another system  200  for enlarging a passage within the body of a patient, which is similar to the previously described systems  20 ,  50 , and  100 . Thus, the previous description of the systems  20 ,  50 ,  100  also pertain to the system  200 . The 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  in fluid communication with a support balloon  212 . The first tubular portion  206  is similarly structured to the tubular portion  106 . For example, the first tubular portion  206  also includes protrusions  214 , and the support balloon  212  being coupled to the exterior surface of the first tubular portion  206  between adjacent protrusions  214 . As also previously described, the first tubular portion  206  can also include a liner with a braided filament. 
     The second tubular portion  208  is illustrated as having a bore directed therethrough. In some specific embodiments the second tubular portion  208  is a hypo-tube. In some embodiments, a portion of the second tubular portion  208  can 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 aperture) to receive the balloon catheter  204 . As shown, the inflation tube  210  is coupled to and extends along the exterior surface of the first tubular portion  206 , extends through (and can be coupled to an interior surface of) the second tubular portion  208 , extends into (or externally relative to) a handle  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 once the fluid infusion device is interfaced with the port adapter  218 , the fluid infusion device is also in fluid communication with the inflation tube  210 . This way, the fluid infusion device can provide a fluid to the support balloon  212  via the inflation tube  210 . 
     As shown, the support sleeve  202  also includes a coupling portion  220  that selectively allows or restricts 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 removably coupled to the support sleeve  202 , such that when the balloon catheter  204  is advanced into the vasculature of the patient, the balloon catheter  204  can be advanced with the support sleeve  202  (when coupled), or alternatively, advanced alone (when the balloon catheter  204  is decoupled from the support sleeve  202 ). In the illustrated embodiment of  FIG. 6 , the coupling portion  220  is implemented as being a wire  222  (or other tethering structure) interfaced with a winch  224 . The winch  224  is illustrated as having a rotatable handle that interfaces with gears, other rotating components such as a shaft, etc., to draw in (or out, such as to provide slack) one end of the wire  222 , while the other end of the wire  222  can be fixed to a portion of the winch  224  (e.g., the rotatable shaft of the winch) or other structure. The wire  222  can have an appropriate size, and can be made out of various materials. For example, the wire  222  can be formed out of a super elastic metal (e.g., nitinol), and can be made to have a thickness being, for example, 0.004 inches, 0.0006 inches, etc. In some cases, the wire  222  can be rounded (e.g., free of edges), and in other cases the wire  222  can be formed of other materials, such as plastics. 
     The wire  222  (and the winch  224 ) generally allows the support sleeve  202  to be removably coupled to the balloon catheter  204 . For example, as shown the wire  222  is looped around the balloon catheter  204 , and thus when the wire  222  is taught (e.g., via tightening by 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 restriction by the wire  222  allows the balloon catheter  204  and the support sleeve  202  to be advanced together along the vasculature of the patient. Stated another way, relative movement between the balloon catheter  204  and the support sleeve  202  is prevented. Alternatively, when the wire  222  is loosened (e.g., via rotating the winch  224  in the opposing direction), the loop of the wire  222  increases in size and decreases the contact between the wire  222  and the balloon catheter  204 . As such, this loosing of the wire  222  temporarily decouples the balloon catheter  204  from the wire. This loosening allows the balloon catheter  204  to freely translate relative to the support sleeve  202 . Similarly, to the other systems described above, a degree of tightness (or looseness) of the loop of the wire  222  can increase (or decrease) the force required to advance the balloon catheter  204 . 
       FIG. 7  shows a flow chart of a process  300  for widening a narrowed blood vessel. In some embodiments, the process  300  can utilize a guidewire, a balloon catheter having a distal end and a proximal end, a support sleeve having a support balloon, and other components. At  302 , process  300  includes placing and feeding a guidewire and a balloon catheter into the vascular system of the patient. For example, a physician can feed and place the guidewire, followed by feeding and placing the balloon catheter up to the narrowed blood vessel segment. If the balloon catheter can be advanced into place to widen the narrowed segment, then the physician can do so and complete the procedure. If the balloon catheter cannot be advanced through the narrowed segment, the balloon catheter can be retracted back out of the patient. In some forms, the physician does not need to test for a problem with the advancement of the balloon catheter, but rather can begin the procedure with the support sleeve attached to the balloon catheter. 
     At  304 , process  300  includes sliding the support sleeve over the balloon catheter. For example, the support sleeve can be slid over the distal end of the balloon catheter and advanced to a desired position. At  306 , process  300  includes temporarily coupling the balloon catheter to the support sleeve. For example, the balloon can be temporarily coupled to the balloon catheter between an enlarging balloon of the balloon catheter and the proximal end. 
     At  308 , process  300  includes advancing the support sleeve and the balloon catheter together over the guidewire. For example, once the balloon catheter is temporarily coupled to the support sleeve, the balloon catheter and the support sleeve can be advanced together through the patient&#39;s circulatory system until the narrowed vessel segment is reached. 
     At  310 , process  300  includes decoupling the support sleeve from the balloon catheter when the balloon catheter reaches the narrowed blood vessels. In some cases, the practitioner can visually determine (e.g., on a medical image of the procedure), or can determine in a tactile sense (e.g., from resistance, or difficulty in advancement of balloon catheter with the support sleeve) that the balloon catheter has reached the narrowed blood vessel. Regardless, the balloon catheter can be decoupled from the support sleeve to allow the balloon catheter to translate (or move) relative to the support sleeve. 
     At  312 , process  300  includes inflating the balloon of the support sleeve. After the balloon catheter is decoupled from the support sleeve, the support balloon can be inflated to contact and thus anchor the support sleeve at a location within the blood vessel. 
     At  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 the inflation of the support balloon), the balloon catheter can be advanced into the narrowed blood vessel segment and positioned accordingly. For example, the enlarging balloon of the balloon catheter can be positioned entirely within the narrowed portion of the vessel desired to be expanded. In some cases, use of the support sleeve may allow the balloon catheter to be advanced beyond a first narrowed portion of the patient&#39;s vasculature, but a second narrowed portion may be encountered before the balloon catheter can reach the desired segment. In these instances, the balloon of the support sleeve can be deflated and the support sleeve advanced over the balloon catheter at the second narrowed portion. The support sleeve can then be redeployed by inflating the balloon of the support sleeve at this second, more distal narrowed portion of the patient&#39;s vasculature. This process can be repeated several times, if necessary, to reach the desired segment in the patient&#39;s vasculature. 
     At  316 , process  300  include 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 needed, a stent can also be placed by the balloon catheter as the enlarging balloon expands. 
     At  318 , process  300  can include deflating the balloon catheter and retracting the balloon catheter from the narrowed (and now expanded) blood vessel. For example, when sufficient enlarging balloon inflation and vessel widening has occurred or if for any other reasons the balloon catheter needs to be removed from the patient, the enlarging balloon can be deflated and the balloon catheter can be retracted. 
     At  320 , process  300  can include deflating the support balloon, coupling (temporarily) 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 can be coupled to the support sleeve (with the support balloon inflated). Then, the support balloon can be deflated and the balloon catheter and support sleeve can be retracted together from the patient. Although this description has set out specific embodiments of a method of widening a narrowed blood vessel, it should be noted that a number of these steps may take place in a different order than described. 
     The present disclosure has described one or more preferred embodiments, and it should be appreciated that many equivalents, alternatives, variations, and modifications, aside from those expressly stated, are possible and within the scope of the invention.