Abstract
The disclosed invention is in the field of medical devices, namely angioplasty balloon catheters. The embodiments provide an angioplasty balloon catheter that has favorable features of both biaxial and coaxial lumen configurations, such as pushability, torque, and trackability, enabled by a transition between a biaxial catheter segment and a coaxial catheter segment. In an exemplary embodiment a biaxial-coaxial lumen configuration facilitates injection of fluids through the catheter and out of the catheter proximal to its distal tip end with a guidewire in place in the catheter.
Claims
1. An angioplasty balloon catheter comprising a tubular shaft disposed between a hub end and a tip end, and an expansile balloon mounted to said tubular shaft disposed toward said tip end, said tubular shaft comprising two lumens including a first lumen for passage of a guidewire or injection of fluids therethrough and a second lumen for injection of fluids or gases to inflate and deflate said expansile balloon, said tubular shaft further comprising a biaxial lumen configuration along less than an entire tubular shaft length and a coaxial lumen configuration along less than an entire tubular shaft length.
2. The angioplasty balloon catheter of claim 1 wherein said biaxial configuration is disposed proximal to said coaxial configuration.
3. The angioplasty balloon catheter of claim 3 wherein a transition between said biaxial configuration and said coaxial configuration is located closer to said tip end than to said hub end.
4. The angioplasty balloon catheter of claim 1 wherein an outer diameter of said tubular shaft biaxial segment is at least 0.5 French larger than an outer diameter of said tubular shaft coaxial segment.
5. The angioplasty balloon catheter of claim 1 wherein a cross-sectional area of said first lumen in said coaxial lumen configuration tubular shaft is smaller compared to an inner diameter of said first lumen in said biaxial lumen configuration by at least 0.5 square millimeters.
6. The angioplasty balloon catheter of claim 3 wherein said transition comprises an intrusion of said first lumen into said second lumen such that between said biaxial configuration and said coaxial configuration a circumference of said first lumen becomes progressively more circumscribed by a circumference of said second lumen until it is completely circumscribed by it around 360 degrees of its circumference.
7. An angioplasty balloon catheter comprising a tubular shaft disposed between a hub end and a tip end, and an expansile balloon mounted to said tubular shaft disposed toward said tip end, said tubular shaft further comprising a biaxial lumen configuration along less than an entire tubular shaft length and a coaxial lumen configuration along less than an entire tubular shaft length, said tubular shaft further comprising three lumens including a first lumen for passage of a stiffening wire or injection of fluids therethrough, said first lumen extending from a proximal hub partly through a length of said tubular shaft and terminating within a length of said tubular shaft, a second lumen for injection of fluids or gases to inflate and deflate said expansile balloon, and a third lumen for passage of a guidewire therethrough extending from a distal tip end proximally through a guide wire port in a side wall of said tubular shaft.
8. The angioplasty balloon catheter of claim 7 wherein said first lumen and said third lumen overlap along at least 1 mm of a length of said tubular shaft.
9. A method of performing an angioplasty of a blood vessel of a human patient comprising in combination: a) Gaining percutaneous access to a vascular system in a human patient; b) Manipulating a guide wire and an angioplasty balloon catheter comprising a tubular shaft disposed between a hub end and a tip end, and an expansile balloon mounted to said tubular shaft disposed toward said tip end, said tubular shaft comprising two lumens including a first lumen for passage of a guidewire or injection of fluids therethrough and a second lumen for injection of fluids or gases to inflate and deflate said expansile balloon, said tubular shaft further comprising a biaxial lumen configuration along less than an entire tubular shaft length and a coaxial lumen configuration along less than an entire tubular shaft length so that said expansile balloon is generally situated centrally on a blockage in a blood vessel; c) Injecting fluids or gases into a lumen in communication with an interior of an expansile balloon generally disposed toward a tip end of said angioplasty balloon catheter to inflate said expansile balloon; d) Aspirating said fluids or gases to deflate said expansile balloon.
10. A method of performing an angioplasty of a blood vessel of a human patient comprising in combination: a) Gaining percutaneous access to a vascular system in a human patient; b) Manipulating a guide wire and an angioplasty balloon catheter comprising a tubular shaft disposed between a hub end and a tip end, and an expansile balloon mounted to said tubular shaft disposed toward said tip end, said tubular shaft further comprising a biaxial lumen configuration along less than an entire tubular shaft length and a coaxial lumen configuration along less than an entire tubular shaft length, said tubular shaft further comprising three lumens including a first lumen for passage of a stiffening wire or injection of fluids therethrough, said first lumen extending from a proximal hub partly through a length of said tubular shaft and terminating within a length of said tubular shaft, a second lumen for injection of fluids or gases to inflate and deflate said expansile balloon, and a third lumen for passage of a guidewire therethrough extending from a distal tip end proximally through a guide wire port in a side wall of said tubular shaft so that said expansile balloon is generally situated centrally on a blockage in a blood vessel; c) Injecting fluids or gases into a lumen in communication with an interior of an expansile balloon generally disposed toward a tip end of said angioplasty balloon catheter to inflate said expansile balloon; d) Aspirating said fluids or gases to deflate said expansile balloon.
11. The method of performing an angioplasty of a blood vessel of a human patient of claim 10 wherein said angioplasty balloon catheter first lumen and said third lumen overlap along at least 1 mm of a length of said tubular shaft.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0033] FIG. 1 depicts a preferred embodiment of the invention, in this case an angioplasty balloon catheter with a biaxial-coaxial transition segment, as seen from a lateral surface rendering view.
[0034] FIG. 2 is an expanded view of a biaxial-coaxial transition segment in FIG. 1. Subsequent figures are cross-section views and are labeled on this figure with the direction that the subsequent figures are viewed indicated by the direction of arrows.
[0035] FIG. 3 is a cross-section view of a proximal biaxial segment, taken proximal to a biaxial-coaxial transition as indicated generally by the arrow labeled “3” on FIG. 2.
[0036] FIG. 4 is a cross-section view of FIG. 2 taken within a biaxial-coaxial transition segment disposed toward a proximal shaft, as indicated generally by the arrow labeled “4” on FIG. 2.
[0037] FIG. 5 is a cross-section view of FIG. 2 taken within a biaxial-coaxial transition segment, as indicated generally by the arrow labeled “5” on FIG. 2.
[0038] FIG. 6 is a cross-section view of FIG. 2 taken within a biaxial-coaxial transition disposed toward a distal shaft, as indicated generally by the arrow labeled “6” on FIG. 2.
[0039] FIG. 7 is a cross-section view of a distal shaft, taken distal to a biaxial-coaxial transition segment, as indicated generally by the arrow labeled “7” on FIG. 2.
[0040] FIG. 8 is a longitudinal section of FIG. 2, depicting an exemplary embodiment of a portion of a biaxial-coaxial transition segment, also including a portion of a proximal biaxial segment and a portion of a distal coaxial segment.
[0041] FIG. 9 is another longitudinal section of FIG. 2, depicting another exemplary embodiment of a portion of a biaxial-coaxial transition segment, also including a portion of a proximal biaxial segment and a portion of a distal coaxial segment.
DETAILED DESCRIPTION
[0042] Certain exemplary embodiments will now be described to provide an overall understanding of the principles of the structure, function, manufacture, and use of the devices and methods disclosed herein. One or more examples of these embodiments are illustrated in the accompanying drawings. Those skilled in the art will understand that the devices and methods specifically described herein and illustrated in the accompanying drawings are non-limiting exemplary embodiments and that the scope of the present invention is defined solely by the claims. The features illustrated or described in connection with one exemplary embodiment may be combined with the features of other embodiments. Such modifications and variations are intended to be included within the scope of the present invention.
[0043] Devices and related methods are disclosed that generally involve the invention comprising an angioplasty balloon catheter further comprising a biaxial-coaxial transition, the means of manufacture of the invention, and the use of the invention during an angioplasty procedure.
[0044] FIG. 1 depicts a preferred embodiment of the invention, in this case an angioplasty balloon catheter with a proximal hub end comprising a first port 1 for passage of a guidewire and injection of fluids therethrough, said proximal hub end further comprising a second port 2 as a means for injection of fluid or gas as means of inflation of an expansile balloon 6 generally disposed toward a tip end 7 of said angioplasty balloon catheter, said angioplasty balloon catheter further comprising a shaft which is a substantially tubular element generally disposed between said proximal hub end and said tip end 7, said shaft comprising at least two lumens, including at least a first lumen for passage of a guidewire and injection of fluids therethrough, and at least a second lumen for injection of fluids or gases as a means of inflation of said expansile balloon 6, said second lumen in fluid communication with an interior of said expansile balloon 6, in this preferred embodiment said shaft comprising a proximal shaft 3 which comprises two lumens oriented in a biaxial configuration in which said two lumens are substantially parallel and side-by-side, said shaft further comprising a distal shaft 5 which comprises two lumens oriented in a coaxial configuration in which one lumen is contained in and circumscribed by the other lumen, in this preferred embodiment said shaft further comprising a biaxial-coaxial transition segment 4 comprising a location for transition of the orientation of the two lumens from a proximal biaxial configuration to a distal coaxial configuration, in this preferred embodiment said biaxial-coaxial transition segment 4 being located closer to said tip end 7 than to a proximal hub end first port 1. It is well-known to those in the art that said proximal shaft 3, said distal shaft 5, and said biaxial-coaxial transition segment 4 can be formed of any known material suitable for similar medical devices including such materials as polyamides, polyurethanes, polyesters, polyether ether ketones, and polyethylenes, or any combination thereof. In this preferred embodiment, said biaxial-coaxial transition segment 4 further comprises a taper, wherein said proximal shaft has a larger O.D. than said distal shaft, for example, by between 0.5 and 3 French sizes.
[0045] FIG. 2 is an expanded view of a biaxial-coaxial transition segment 4 as shown in FIG. 1. Orientation and perspective of subsequent cross-section views are depicted using dashed lines and figure numbers for subsequent figures, arrows indicating a general perspective from which subsequent cross-section images is viewed.
[0046] FIG. 3 is an exemplary view of a preferred embodiment of a proximal shaft 3, depicting a first lumen 8 for passage of a guidewire or injection of fluids therethrough, and a second lumen 9 for injection of fluids or gases as a means of inflation of said expansile balloon 6, said lumens being in a biaxial configuration.
[0047] FIG. 4 is an exemplary view of a preferred embodiment of a biaxial-coaxial transition segment 4, depicting a first lumen 8 for passage of a guidewire or injection of fluids therethrough, and a second lumen 9 for injection of fluids or gases as a means of inflation of said expansile balloon 6, said lumens being substantially biaxial, except said second lumen 8 is transitioning from a biaxial to a coaxial configuration in this example by intrusion of said first lumen 8 into a lumen of a second lumen 9 such that a circumference of said first lumen is partially circumscribed by a circumference of said second lumen 9.
[0048] While not drawn exactly to scale, the intent of the figures of this exemplary embodiment is to convey a transition in an overall O.D. of a biaxial-coaxial transition segment 4 from larger to smaller as it passes from biaxial to coaxial segments.
[0049] Moreover, while not drawn exactly to scale, the intent of the figures in this exemplary embodiment is to convey a reduction in the relative caliber of said first lumen 8 at some point in the transition from biaxial to coaxial. For example, a proximal biaxial segment 3 could have an outer diameter of 4.7 French, and a distal coaxial segment 5 outer diameter of 4.2 French, resulting in a taper of 0.5 French. Similarly, a proximal biaxial segment 3 could have an outer diameter of 4.7 French, and a distal coaxial segment 5 outer diameter of 1.7 French, resulting in a taper of 3 French. Furthermore, said first lumen diameter could also taper in some exemplary embodiments between a proximal biaxial segment and a distal coaxial segment. For example, a first lumen diameter of 0.040″ in a proximal biaxial segment could taper to a diameter of 0.016″ in a distal coaxial segment, thereby resulting in a reduction in cross sectional area from approximately 0.77 square millimeters to approximately 0.13 square millimeters, or a reduction in cross-sectional area of a first lumen of at least 0.5 square millimeters.
[0050] FIG. 5 is an exemplary view of a preferred embodiment of a biaxial-coaxial transition segment 4, depicting a first lumen 8 for passage of a guidewire or injection of fluids therethrough, and a second lumen 9 for injection of fluids or gases as a means of inflation of said expansile balloon 6, said lumens transitioning between biaxial configuration and coaxial configuration in this example by further intrusion of said first lumen 8 into a lumen of a second lumen 9 such that a greater circumference of said first lumen is partially circumscribed by a circumference of said second lumen 9 as compared to that shown in FIG. 4, having features of both biaxial and coaxial configurations because for example said second lumen 9 is circumscribed by first lumen 8 over generally 270 degrees of its circumference, but is not entirely circumscribed by first lumen 8 around 360 degrees of its circumference, and second lumen 9 over at least part of a circumference maintains physical contact with a wall of a lumen of first lumen 8.
[0051] FIG. 6 is an exemplary view of a preferred embodiment of the invention transition 4, depicting a first lumen 8 for passage of a guidewire or injection of fluids therethrough, and a second lumen 9 for injection of fluids or gases as a means of inflation of said expansile balloon 6, said lumens transitioning between biaxial configuration and coaxial configurations in this example by further intrusion of said first lumen 8 into a lumen of a second lumen 9 as compared to that shown in FIG. 5 such that a circumference of said first lumen is partially circumscribed by a circumference of said second lumen 9, having features of both configurations, said first lumen 8 being circumscribed by said second lumen 9 over less than 360 degrees of its circumference, second lumen 9 over at least part of a circumference maintaining physical contact with a wall of a lumen of first lumen 8, said walls of said first lumen 8 and said second lumen 9 maintaining a physical connection over at least part of their respective circumferences.
[0052] FIG. 7 is an exemplary view of a preferred embodiment of the invention distal shaft 5, depicting a first lumen 8 for passage of a guidewire or injection of fluids therethrough, and a second lumen 9 for injection of fluids or gases as a means of inflation of said expansile balloon 6, said lumens being in a coaxial configuration.
[0053] FIG. 8 is a longitudinal section of FIG. 2, depicting an exemplary embodiment of a a biaxial-coaxial transition segment 4, also including a portion of a proximal biaxial segment 3 and a portion of a distal coaxial segment 5. Said distal coaxial segment 5 and said transition segment 4 comprise a guidewire lumen 8, in this illustration said guidewire lumen 8 also extends proximally into said proximal biaxial segment 3 then fuses with a proximal biaxial segment 3 sidewall and thereby in fluid communication with an exterior through a guidewire port 11. Said guidewire lumen 8 is depicted with a guidewire 10 in situ, said guidewire extending throughout a length of said distal coaxial segment 5, said biaxial-coaxial transition segment 4, and into a distal part of said proximal biaxial segment 3 before exiting through a guidewire port 11 in a side wall of said catheter. In this exemplary embodiment said catheter proximal biaxial segment 3 comprises a lumen 12 used for injection of fluids or gases as well as for locating a stiffening member 13. Said proximal biaxial segment 3 further comprises at least one injection port 14 for exit of fluids injected into said proximal biaxial segment 3 by an operator.
[0054] FIG. 9 is a longitudinal section of FIG. 2, depicting another exemplary embodiment of a biaxial-coaxial transition segment 4, also including a portion of a proximal biaxial segment 3 and a portion of a distal coaxial segment 5. This example differs from that of FIG. 8 in that a guidewire lumen 8 does not extend proximally to fuse with a proximal biaxial segment 3 sidewall to form a guidewire port 11, but rather ends proximally within said biaxial-coaxial transition segment 4, in fluid communication with said proximal biaxial segment 3 first lumen 12. A guidewire 10 in situ in a distal coaxial segment 5 would in this embodiment pass proximally into said proximal biaxial segment 3 and then exit a guidewire port 11. Alternatively, in this embodiment, said guidewire 10 could extend proximally through a lumen 12 of said proximal biaxial segment 3 and exit the catheter through a proximal hub end first port 1, thereby comprising over-the-wire use configuration. Such a configuration could be converted between rapid exchange and over-the-wire configurations by an operator during use.
