Abstract:
A method of using a balloon catheter, comprising the steps of providing a balloon catheter, the balloon catheter comprising a balloon and a plurality of fins, the plurality of fins engaged to the balloon; inserting the balloon catheter into the vasculature; advancing the balloon catheter through the vasculature to a desired location; inflating the balloon when the balloon catheter is at the desired location; deflating the balloon; and directing the blood flow along the balloon thereby aiding rewrap.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    Not Applicable 
       STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH 
       [0002]    Not Applicable 
       FIELD OF THE INVENTION 
       [0003]    In some embodiments this invention relates to delivery systems, such as catheter systems of all types, which are utilized in the delivery of such implantable medical devices. 
       BACKGROUND OF THE INVENTION 
       [0004]    Percutaneous transluminal angioplasty (PTA), including percutaneous transluminal coronary angioplasty (PTCA), is a procedure which is well established for the treatment of blockages, lesions, stenosis, thrombus, etc. present in body lumens, such as the coronary arteries and/or other vessels. 
         [0005]    Percutaneous angioplasty makes use of a dilatation balloon catheter, which is introduced into and advanced through a lumen or body vessel until the distal end thereof is at a desired location in the vasculature. Once in position across an afflicted site, the expandable portion of the catheter, or balloon, is inflated to a predetermined size with a fluid at relatively high pressures. By doing so the vessel is dilated, thereby radially compressing the atherosclerotic plaque of any lesion present against the inside of the artery wall, and/or otherwise treating the afflicted area of the vessel. The balloon is then deflated to a small profile so that the dilatation catheter may be withdrawn from the patient&#39;s vasculature and blood flow resumed through the dilated artery. 
         [0006]    In angioplasty procedures of the kind described above, there may be restenosis of the artery, which either necessitates another angioplasty procedure, a surgical by-pass operation, or some method of repairing or strengthening the area. To reduce restenosis and strength the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, such as a stent, inside the artery at the lesion. 
         [0007]    The art referred to and/or described above is not intended to constitute an admission that any patent, publication or other information referred to herein is “prior art” with respect to this invention. In addition, this section should not be construed to mean that a search has been made or that no other pertinent information as defined in 37 C.F.R. §1.56(a) exists. 
         [0008]    All US patents and applications and all other published documents mentioned anywhere in this application are incorporated herein by reference in their entirety. 
         [0009]    Without limiting the scope of the invention a brief summary of some of the claimed embodiments of the invention is set forth below. Additional details of the summarized embodiments of the invention and/or additional embodiments of the invention may be found in the Detailed Description of the Invention below. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    In at least one embodiment, the invention is directed to a balloon catheter with improved rewrapping. In at least one embodiment, the balloon catheter has a plurality of fins engaged to the balloon. In at least one embodiment, the balloon catheter has a plurality of fins engaged to the cone of the balloon. In at least one embodiment, the invention is directed to a balloon catheter with at least one tether engaged to the interior surface of the balloon and a plurality of flow channels positioned in the inner shaft. In at least one embodiment, a collar with flow channels is engaged to the inner shaft of a balloon catheter with at least one tether engaged to the interior surface of the balloon. 
         [0011]    In at least one embodiment, the invention is directed to a method of using a balloon catheter with a plurality of fins engaged to the balloon. In at least one embodiment, the invention is direction to a method of using a balloon catheter with at least one tether engaged to the interior surface of the balloon and a plurality of flow channels positioned between the outer shaft and the inner shaft, the balloon or both the inner shaft and the balloon. 
         [0012]    These and other embodiments which characterize the invention are pointed out with particularity in the claims annexed hereto and forming a part hereof However, for further understanding of the invention, its advantages and objectives obtained by its use, reference can be made to the drawings which form a further part hereof and the accompanying descriptive matter, in which there is illustrated and described an embodiments of the invention. 
     
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING(S) 
         [0013]    A detailed description of the invention is hereafter described with specific reference being made to the drawings. 
           [0014]      FIG. 1   a  is a side view of a balloon catheter with a balloon that has fins. 
           [0015]      FIG. 1   b  is a cross-section of the balloon catheter of  FIG. 1   a  taken at line  1   b - 1   b.    
           [0016]      FIG. 1   c  is a side view of  FIG. 1   a  with the fins at an angle to the longitudinal axis of the catheter. 
           [0017]      FIG. 2   a  is a cross-section of the blood vessel with the balloon catheter of  FIG. 1   c  where the balloon is in an un-inflated state. 
           [0018]      FIG. 2   b  is a cross-section of  FIG. 2   a  with the balloon in an inflated state and the blood flow forming an eddy 
           [0019]      FIG. 2   c  is a cross section of  FIG. 2   b  with the balloon in an inflated state and the blood flow circling the catheter at the proximal end of the balloon. 
           [0020]      FIG. 2   d  is the cross section of  FIG. 2   c  with the balloon in a partially deflated state and the blood flow directed across the balloon by the fins. 
           [0021]      FIG. 2   e  is the cross-section of  FIG. 2   d  with the balloon in a rewrapped state. 
           [0022]      FIG. 3   a  is a longitudinal cross-section of a balloon catheter with at least one tether engaged to the interior surface of the balloon and the surface of the inner shaft has a flow channel. 
           [0023]      FIG. 3   b  is a longitudinal cross-section of the balloon catheter of  FIG. 3   a  during the deflation of the balloon. 
           [0024]      FIG. 3   c  is a perspective view of a collar engaged to the inner shaft of a balloon catheter. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0025]    While this invention may be embodied in many different forms, there are described in detail herein specific embodiments of the invention. This description is an exemplification of the principles of the invention and is not intended to limit the invention to the particular embodiments illustrated. 
         [0026]    For the purposes of this disclosure, like reference numerals in the figures shall refer to like features unless otherwise indicated. 
         [0027]    The catheters employed in the practice of the present invention are most conveniently constructed as over-the-wire balloon catheters of convention form for use in angioplasty. However, it should be understood that the present invention can be applied, in addition to over-the-wire catheters, to fixed-wire catheters, to shortened guide wire lumens or single operator exchange catheters, and to non over-the-wire balloon catheters. Furthermore this invention can be used with balloon catheters intended for use in any and all vascular systems or cavities of the body 
         [0028]      FIGS. 1   a  and  b  illustrate an embodiment of the balloon catheter  10  with fins  34  engaged to the proximal cone  30  of the balloon  26 . The fins  34  can have any configuration as long as they aid in the rewrap of the balloon  26 , as discussed in greater detail below. In the embodiment shown in  FIGS. 1   a  and  1   b , each fin  34  has a bottom surface, a top surface and at least one side engaging the bottom surface and the top surface of the fin  34 . It is within the scope of the invention for the fin  34  to have one, two, three, four, five, six, seven, eight, nine, ten, or more sides. In this embodiment, the bottom surface and the top surface of the fin  34  each have an area with the top surface area smaller than the bottom surface area. However it is within the scope of the invention for the top surface area to be smaller than, equal to, or greater than, the bottom surface area. The plurality of sides engaging the bottom surface and the top surface of the fin  34  are at an oblique angle to the longitudinal axis of the balloon catheter  10 . As used in this application, an oblique angle is any angle between about 0 and about 180 degrees and includes 90 degrees. 
         [0029]    It is within the scope of the invention for the bottom surface of the fins  34  to be engaged to at least one of the proximal cone  30 , the proximal waist or the proximal body of the balloon  26 . The fins  34  can be engaged to the exterior surface of the balloon  26  by any suitable means. Since the bottom surface of the fin  34  is engaged to the exterior surface of the balloon  26 , the bottom surface of the fin  34  has a shape that is complementary to the shape of the exterior surface of the balloon  26 .  FIG. 1   a  is a side view of the distal end of the balloon catheter  10 . The proximal cone  30  of the balloon  26  has fins  34  positioned about the circumference. It is within the scope of the invention for the fins  34  to have the same longitudinal position on the balloon  26  or for at least one fin  34  to have a different longitudinal position on the balloon  26  than the other fins  34 . In this embodiment, there are four fins  34  which are parallel to the longitudinal axis of the balloon catheter  10 . In  FIG. 1   c , the fins  24  are at an oblique angle to the longitudinal axis (1) of the balloon catheter  10 . It is within the scope of the invention for there to be two, three, four, five, six or more fins  34  about the circumference of the proximal cone  30  of the balloon  26 .  FIG. 1   b  is a cross-section of the balloon  26  of  FIG. 1   a  taken at line  1   b - 1   b.    
         [0030]    In at least one embodiment, the fins  34  are manufactured with semi-compliant material, for example, but not limited to, ethylene-vinyl acetate, polyvinyl chloride(PVC), olefin copolymers or homopolymers, polyethylenes, polyurethanes, crosslinked low density polyethylenes (PETs), highly irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends and ionomer resins. In at least one embodiment, the fins  34  are manufactured with non-compliant material, for example, but not limited to, polyethylene terephthalates, polyacrylenesulfide, and copolyesters. In at least one embodiment, the fins  34  are manufactured with compliant material, for example, but not limited to, nylon, and polyamines. In at least one embodiment, the fins  34  and the balloon  26  are manufactured from the same material. 
         [0031]      FIGS. 2   a - 2   d  illustrate how the blood flow (BF) within the blood vessel  40  helps to rewrap the balloon catheter embodiment of  FIG. 1   c . In  FIG. 2   a , the blood vessel  40  has the balloon catheter  10  embodiment of  FIG. 1   c  within it. The balloon  26  is in its non-expanded, pre-deployment state. The blood flow (BF) in the blood vessel  40  flows around the balloon catheter  10 , as indicated by the arrows. In  FIG. 2   b , the balloon  26  has been inflated and the sides of the balloon  26  are engaged to the wall of the blood vessel  40 . In at least one embodiment, because the balloon  26  is occluding the blood vessel  40 , the blood flow (BF), as indicated by the arrows, forms an eddy in which the blood flow (BF) begins to circle the catheter shaft in either a clockwise direction or counter clockwise direction, as illustrated in  FIG. 2   c . In one embodiment, the angle of the fins  34  affects the direction of the blood flow. 
         [0032]    Once the treatment with the balloon catheter  10  is completed, the balloon  26  is partially deflated by means known in the art, as illustrated in  FIG. 2   d . Once the balloon  26  is partially deflated, the blood flow (BF) past the balloon  26  is no longer inhibited. In at least one embodiment, fluid from the balloon catheter  10  is released into the blood stream at a point proximal to the balloon  26  so that the amount of fluid going past the balloon  26  is increased. In at least one embodiment, fluid is released from holes in the outer shaft. In at least one embodiment, fluid is released from holes in the proximal waist of the balloon  26 . In at least one embodiment, the fluid released from the balloon catheter  10  into the blood flow increases the pressure of the blood flow against the balloon  26 . 
         [0033]    In at least one embodiment, due to the position of the fins  34  relative to the longitudinal axis of the balloon catheter  10 , the blood flow (BF) flows in prescribed paths about the balloon  26 . The channeling of the blood flow (BF), indicated by the double arrows, also increases the pressure of the blood flow against the balloon  26  along those pathways, due to the concentration of the blood flow (BF) into those particular pathways. In at least one embodiment, due to the position of the fins  34  relative to the longitudinal axis of the balloon catheter  10 , as the blood flows past the balloon  26 , the fins  34  move in a circumferential direction, as illustrated in  FIG. 2   d  by the arrow indicating the movement of one of the fins  34 . The circumferential movement of the fins  34  helps the balloon  26  to rewrap.  FIG. 2   e  shows the balloon  26  in a rewrapped state. 
         [0034]      FIGS. 3   a  and  b  illustrates an embodiment of the balloon catheter  10  that has at least one tether  32  engaged to the interior surface of the balloon  26  and at least one flow channel  36  on the exterior surface of the inner shaft  16 . The at least one flow channel  36  can extend along the longitudinal length of the inner shaft  16  for any length so long as it is sufficiently long to aid in balloon re-wrap, as discussed in greater detail below. In at least one embodiment, the flow channel  36  is helical, as illustrated in  FIGS. 3   a  and  3   b . As shown in  FIG. 3   a , the body of the inner shaft  16  defines the flow channel  36 . Thus, the inner shaft  16  has a variable outer diameter, with the portion of the inner shaft  16  having the flow channel  36  having an outer diameter that is less than the portion of the inner shaft  16  that does not have the flow channel  36 . 
         [0035]    In at least one embodiment, a collar  38  that defines at least one flow channel  36  is engaged to the inner shaft  16 , as illustrated in  FIG. 3   c . The collar  38  can have any length and diameter so long as the dimensions are sufficiently large enough to define at least one flow channel  36  that aids in balloon rewrap, discussed in greater detail below. Thus, the collar  38  can have a length ranging from 1 mm to 1000 mm and a diameter ranging from 0.5 mm to 5 mm. In at least one embodiment, the outer surface of the collar  38  engages the inner surface of the outer shaft so that the inflation lumen at the position of the collar  38  is the flow channels  36  in the outer surface of the collar  38 . In at least one embodiment, the collar  38  is manufactured from the same material as the inner shaft  16 . In at least one embodiment, the collar  38  is manufactured from a different material than the inner shaft  16 . 
         [0036]    In  FIG. 3   c , the collar  38  has a twisted triangular shape so that the apexes, for example apex A 1 , extend in a helical manner from the distal end of the collar  38  to the proximal end of the collar  38 . Between the apexes there are indentations which form the flow channels  36 . In this embodiment, there are three flow channels  36  extending in a helical manner with a counter clockwise flow from the distal end  12  of the collar  38  to the proximal end  14  of the collar  38 . Thus, it is within the scope of the invention for the balloon catheter  10  to have one, two, three, four, five, six or more flow channels  36  on the inner shaft  16 , the collar  38 , the balloon  26 , and any combination thereof. Note that collar  38  can have any shape so long as it has at least one flow channel  36  which allows the inflation media to flow in either a clockwise or a counter clockwise direction. For example, in one embodiment, the collar  38  is substantially round and defines a flow channel  36  in the outer surface of the collar  38 , similar to the inner shaft  16  of  FIGS. 3   a  and  3   b.    
         [0037]    The balloon catheter  10  has at least one tether  32  engaged to the interior surface of the balloon  26 . The tethers  32  can be engaged to the balloon  26  by any suitable means. It is within the scope of the invention for a tether  32  to be engaged to any portion of the balloon  26 , e.g. body, cone, or waist so long as the tether  32  can facilitate re-wrap as discussed in greater detail below. In at least one embodiment, the area of the balloon  26  to which the tethers  32  are engaged is reinforced. In at least one embodiment, the tethers  32  are manufactured with mylar fibers or nylon fiber/thread. It is within the scope of the invention for the tethers  32  to have any configuration, for example, but not limited to, rope-like shape or a ribbon-like shape, so long as the tethers  32  facilitate re-wrap of the balloon  26 . In at least one embodiment, the tethers  32  and the balloon  26  are manufactured from the same material. 
         [0038]    Although for simplicity,  FIGS. 3   a  and  3   b  illustrate only one tether  32 , it is within the scope of the invention for there to be one, two, three, four, five, six, seven, eight, nine, ten or more tethers  32  engaged to the interior surface of the balloon  26 . One end of the tether  32  is engaged to the interior surface of the balloon  26 . The tethers  32  can be engaged to any location on the interior surface of the balloon  26  so long as the tethers  32  aid in the rewrap of the balloon  26 , as explained in greater detail below. In one embodiment, tethers  32  are engaged to the distal portion of the balloon  26 . In one embodiment, each of the tethers  32  is engaged about the circumference of the balloon  26  at one longitudinal position. In one embodiment, at least one of the plurality of tethers  32  is engaged to the interior surface of the balloon  26  at a different longitudinal position from the other tethers  32 . 
         [0039]    As is known in the art, inflation media is used to inflate the balloon  26 . In order to deflate the balloon  26 , the inflation media within the balloon  26  is evacuated or withdrawn from the balloon  26 . As the inflation media is withdrawn, at least a portion the inflation media is drawn into the flow channel  36  and flows in either a clockwise or counterclockwise direction, depending upon the design of the flow channel  36 . In one embodiment, all of the inflation media is directed/drawn into the flow channel  36 . As shown in  FIG. 3   a , the flow channel  36  has a counter clockwise flow. This method of evacuating the inflation media from the balloon  26  is similar to the flow of water from a toilet bowl after it has been flushed. 
         [0040]    As illustrated in  FIG. 3   b , the second end of the tether  32 , the free end, is pulled in a proximal direction, about the inner shaft  16 , by the inflation media as the inflation media is withdrawn from the balloon  26 . Thus, the second end of the tether  32  wraps around the inner shaft  16 , or collar  38  if a collar  38  is used, as the inflation media is withdrawn from the balloon  26 , because at least a portion of the inflation media is flowing within the flow channel  36 . As the free end of the tether  32  wraps around the inner shaft  16  and is being pulled in the proximal direction, the entire tether  32  is pulled down towards the inner shaft  16  thereby facilitating the re-wrap of the balloon  26  since the balloon  26 , which is engaged to the tether  32 , is also pulled down towards the inner shaft  16 . In at least one embodiment, as the tethers  32  wind around the inner shaft  16 , the length of the tethers  32  decreases, thereby pulling the interior of the balloon  26  towards the inner shaft  16 . Another way to describe the action of a plurality of tethers  32  on the balloon  26  is that the tethers  32  look like fan blades as they wind around the inner shaft  16  as the inflation media is evacuated via the flow channel(s)  36  from the balloon  26  in a clockwise or counterclockwise manner. 
         [0041]    The inner shaft  16  is manufactured from any suitable shaft material, for example, but not limited to, polyoxymethylene (POM), polybutylene terephthalate (PBT), polyether block ester, polyether block amide (PEBA), fluorinated ethylene propylene (FEP), polyethylene (PE), polypropylene (PP), polyvinylchloride (PVC), polyurethane, polytetrafluoroethylene (PTFE), polyether-ether ketone (PEEK), polyimide, polyamide, polyphenylene sulfide (PPS), polyphenylene oxide (PPO), polysufone, nylon, perfluoro (propyl vinyl ether) (PFA), polyether-ester, polymer/metal composites, etc., or mixtures, blends or combinations thereof. One example of a suitable polyether block ester is available under the trade name ARNITEL, and one suitable example of a polyether block amide (PEBA) is available under the trade name PEBAX®, from ATOMCHEM POLYMERS, Birdsboro, Pa. 
         [0042]    The balloons  26  can be manufactured from any suitable balloon material. In at least one embodiment, the balloon is manufactured with semi-compliant material, for example, but not limited to, ethylene-vinyl acetate, polyvinyl chloride (PVC), olefin copolymers or homopolymers, polyethylenes, polyurethanes, crosslinked low density polyethylenes (PETs), highly irradiated linear low density polyethylene (LDPE), acrylonitrile polymers and copolymers, acrylonitrile blends and ionomer resins. In at least one embodiment, the balloon is manufactured with non-compliant material, for example, but not limited to, polyethylene terephthalates, polyacrylenesulfide, and copolyesters. In at least one embodiment, the balloon is manufactured with compliant material, for example, but not limited to, nylon, and polyamines. Other balloon materials may also be used. 
         [0043]    In some embodiments, a portion of the balloon catheter  10  may include one or more areas, bands, coatings, members, etc. that is (are) detectable by imaging modalities such as X-Ray, MRI, ultrasound, etc. In some embodiments at least a portion of the balloon catheter  10  is at least partially radiopaque. 
         [0044]    The above disclosure is intended to be illustrative and not exhaustive. This description will suggest many variations and alternatives to one of ordinary skill in this art. The various elements shown in the individual figures and described above may be combined or modified for combination as desired. All these alternatives and variations are intended to be included within the scope of the claims where the term “comprising” means “including, but not limited to”. 
         [0045]    Further, the particular features presented in the dependent claims can be combined with each other in other manners within the scope of the invention such that the invention should be recognized as also specifically directed to other embodiments having any other possible combination of the features of the dependent claims. For instance, for purposes of claim publication, any dependent claim which follows should be taken as alternatively written in a multiple dependent form from all prior claims which possess all antecedents referenced in such dependent claim if such multiple dependent format is an accepted format within the jurisdiction (e.g. each claim depending directly from claim 1 should be alternatively taken as depending from all previous claims). In jurisdictions where multiple dependent claim formats are restricted, the following dependent claims should each be also taken as alternatively written in each singly dependent claim format which creates a dependency from a prior antecedent-possessing claim other than the specific claim listed in such dependent claim below. 
         [0046]    This completes the description of the invention. Those skilled in the art may recognize other equivalents to the specific embodiment described herein which equivalents are intended to be encompassed by the claims attached hereto.