[go: up one dir, main page]

WO2024167735A1 - Cathéter à ballonnet d'angioplastie comprenant une transition biaxiale-coaxiale - Google Patents

Cathéter à ballonnet d'angioplastie comprenant une transition biaxiale-coaxiale Download PDF

Info

Publication number
WO2024167735A1
WO2024167735A1 PCT/US2024/013759 US2024013759W WO2024167735A1 WO 2024167735 A1 WO2024167735 A1 WO 2024167735A1 US 2024013759 W US2024013759 W US 2024013759W WO 2024167735 A1 WO2024167735 A1 WO 2024167735A1
Authority
WO
WIPO (PCT)
Prior art keywords
lumen
tubular shaft
biaxial
expansile
coaxial
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2024/013759
Other languages
English (en)
Inventor
Timothy P. Murphy
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from US18/106,262 external-priority patent/US20230191092A1/en
Application filed by Individual filed Critical Individual
Publication of WO2024167735A1 publication Critical patent/WO2024167735A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/104—Balloon catheters used for angioplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0037—Multi-lumen catheters with stationary elements characterized by lumina being arranged side-by-side
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M2025/0183—Rapid exchange or monorail catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1061—Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube

Definitions

  • the present invention relates to medical devices and medical vascular interventional methods. More particularly, the present invention is directed to medical devices used for angioplasty of intravascular stenoses, and methods of use thereof.
  • An angioplasty balloon catheter comprises a tubular element with an expansile balloon generally disposed toward a distal end.
  • angioplasty balloon catheters comprise at least two lumens, which are tubular channels surrounded by catheter walls, said tubular channels commonly being generally round in cross-section but also comprising semicircles, crescents, or other shapes in cross-section, each lumen further comprising a longitudinal axis generally disposed longitudinally through said lumen through a point generally in the center of a cross-section of a substantially circular lumen, or through a point in a cross-section of a noncircular lumen generally located substantially equidistant on average from every point located on a circumference of said noncircular lumen cross-section as possible such that the sum of all radii connecting said center of said longitudinal axis is the smallest possible value, said at least two lumens comprising at least a first lumen for passage of a guidewire or injection of fluids therethrough, and at least a second lumen as a means
  • Angioplasty balloon catheters typically comprise at least two lumens that can be disposed in relation to each other in either a side-by-side arrangement (“biaxial”), or alternatively a concentric arrangement, said concentric arrangement being substantially a tube-within-a-tube (“coaxial”).
  • Biaxial angioplasty balloon catheters typically have larger outer diameters (O.D.’s) than coaxial angioplasty balloon catheters, and can be extruded together, reducing manufacturing costs compare to coaxial angioplasty balloon catheters, which are typically extruded separately and must be assembled.
  • larger catheters have more “pushability”, or the ability of the catheter to provide more forward force at a distance when advanced by an operator, and “torqueability” or responsiveness at a tip end from a rotational movement by an operator working at a hub end.
  • Coaxial angioplasty balloon catheters offer efficiency because the cross- sectional area of a second lumen for balloon inflation is an outer lumen, and can be larger for a given cross-sectional area compared to a biaxial angioplasty balloon catheter, providing better balloon inflation and deflation performance compared to biaxial angioplasty balloon catheters of the same O.D.
  • Smaller catheters generally have less pushability and torqueability than larger catheters, but have better “trackability”, or the ability to move forward easily in distal, small blood vessels when advanced by an operator by manipulation of a proximal catheter end.
  • Angioplasty procedures are usually performed using percutaneous access to a blood vessel by the Seidinger technique.
  • the Seidinger technique involves placement of a needle through the skin into a blood vessel, passage of a guidewire through a lumen of the needle into the blood vessel, and removal of the needle and replacement with a plastic diagnostic catheter.
  • the guidewire and catheter combination are used by an operator to selectively catheterize a blood vessel with a blockage to be treated, arteriograms are obtained, and then an angioplasty balloon catheter is substituted for the diagnostic catheter and positioned so that an expansile balloon disposed toward a tip end of said angioplasty balloon catheter is generally positioned centrally within said blockage.
  • Said angioplasty balloon is then expanded typically by injection of fluids into a lumen in communication with an interior of said angioplasty balloon, thereby relieving the said blockage.
  • Said expansile balloon is then deflated by aspiration of said injected fluids, and then the catheter is removed entirely from the body.
  • Angioplasty balloon catheters have been used to dilate blockages in blood vessels for over 45 years.
  • the original angioplasty balloon catheter as used by Gruentzig in 1977 was a fixed-wire platform.
  • Simpson and Robert developed a movable guidewire balloon platform, or “ovcr-thc-wirc” (“OTW”), U.S. Pat. No. 4,323,071.
  • the OTW configuration includes a lumen used to inflate an angioplasty balloon and usually a second lumen used for passage of a guidewire therethrough.
  • the guidewire exit port is usually at the distal tip of the catheter, and the guidewire entry port is at the hub or proximal end of the catheter.
  • RX rapid exchange
  • U.S. Pat. No. 4,762,129 the guidewire exit port is at the distal tip of the catheter, but the guidewire entry port is substantially distal to the hub or proximal end of the catheter and proximal to an angioplasty balloon.
  • angioplasty balloon catheters have existed for over 45 years and millions of angioplasty procedures are done annually in the U.S., there is a long-felt unmet need of reducing catheter exchanges between diagnostic catheters and therapeutic angioplasty balloon catheters during an angioplasty procedure.
  • angioplasty balloon catheters are used only for therapeutic purpose of expanding a blockage in a blood vessel.
  • angioplasty balloon catheters typically have a guidewire lumen that can be used for injection of fluids
  • angioplasty balloon catheters typically are not adapted to perform diagnostic functions such as diagnostic angiography, and using an angioplasty balloon catheter for diagnostic angiography by injection of radiopaque fluids through a guidewire lumen would require the guidewire to be absent during the injection of radiopaque fluids, thereby jeopardizing access into a more distal artery that is ensured when a guidewire is in place.
  • diagnostic angiography is typically performed with a diagnostic catheter, then the diagnostic catheter removed and replaced with an angioplasty balloon catheter for performance of an angioplasty, then said angioplasty balloon catheter removed and replaced with a diagnostic catheter again to perform a completion angiography.
  • an angioplasty balloon catheter with a biaxial-coaxial transition combines a biaxial proximal catheter shaft with a coaxial distal catheter shaft, thereby achieving the optimal pushability and torqueability of a larger, biaxial proximal catheter shaft with the trackability of a smaller, coaxial distal catheter shaft, by hybridizing a biaxial proximal catheter shaft with a coaxial distal catheter shaft by bonding them together, typically using heat.
  • angioplasty balloon catheters have the capability of accommodating injection of fluids, such as for example radiopaque contrast, proximal or distal to an expansile balloon while a guidewire remains in place throughout a lumen of said angioplasty balloon catheter, for example as described in Patton (US7873404B1, US8532749B1).
  • fluids such as for example radiopaque contrast
  • One design of an angioplasty balloon catheter that comprises such an injectability feature would be for each function to have a dedicated lumen, thereby requiring at least three lumens, including at least a guidewire lumen, at least a lumen for inflation and deflation of an expansile balloon, and at least a lumen for injection of fluids such as for example radiopaque contrast.
  • One exemplary way to design a single lumen for multiple functions would be to over-size a lumen such that it is of sufficiently larger cross-sectional area than required for its typical guidewire, so that sufficient flow rates can be achieved when fluids arc injected into the same lumen even with a guidewire in place therethrough.
  • This design would require a hub adapter that conforms to a guidewire in a substantially fluid-tight manner forming a choke around said guidewire, but also incorporating an injection port distal to said fluid-tight choke, such as a Touhy-Borst adapter or a hemostasis valve adapter with an injection side port distal to a valve or alternatively a compressible O-ring or disk that deforms to adapt to a fluid-tight configuration around said guidewire when a component of a hub is tightened or otherwise manipulated by an operator.
  • an injection port distal to said fluid-tight choke such as a Touhy-Borst adapter or a hemostasis valve adapter with an injection side port distal to a valve or alternatively a compressible O-ring or disk that deforms to adapt to a fluid-tight configuration around said guidewire when a component of a hub is tightened or otherwise manipulated by an operator.
  • an injection exit port may comprise at least one sidehole through a sidewall of a catheter shaft, either proximal or distal to an expansile balloon but proximal to a catheter distal endhole.
  • a catheter having a biaxial or coaxial lumen configuration Such a design could be accomplished with a catheter having a biaxial or coaxial lumen configuration.
  • said injection exit port could be proximal to a guidewire exit port for a catheter used in a “rapid exchange” configuration, or distal to said guidewire exit port.
  • an angioplasty balloon catheter results in an O.D. that may be larger than desired for performing an angioplasty of a small blood vessel, such as for example a blood vessel in a lower leg or foot.
  • O.D. a small blood vessel
  • coaxial angioplasty balloon catheter configurations are preferred, since they can be made with smaller O.D.’s and yet still have similar balloon inflation-deflation performance as biaxial angioplasty configurations with larger O.D’s.
  • a preferred embodiment of the invention is an angioplasty balloon catheter that combines a biaxial segment proximally that incorporates at least a lumen for inflation-deflation of an expansile balloon and at least a multifunction lumen comprising guidewire passage and injectability, with a smaller distal coaxial segment that only accommodates guidewire passage and inflation-deflation of an expansile balloon.
  • fluid injectability would only be accommodated through the proximal biaxial segment, and therefore at least an injection exit port would need to be disposed along said biaxial proximal catheter segment, or within a transition between a proximal biaxial segment and a distal coaxial segment.
  • angioplasty balloon catheters typically have not incorporated an injectability feature with a guidewire in place therethrough until recently.
  • Injectability of an angioplasty balloon catheter can be achieved using a biaxial lumen throughout said angioplasty balloon catheter, by oversizing a guidewire lumen proximal to an exit sidehole to accommodate radiopaque or other fluid injection around said guidwire in a solution that could be considered obvious, such as that provided by the “Chameleon” angioplasty balloon catheter (Medtronic, Minneapolis, MN).
  • a biaxial-coaxial catheter as described herein is not obvious because the lumens don’t naturally align.
  • an angioplasty balloon catheter comprising a biaxial-coaxial transition further comprises at least a proximal shaft further comprising at least two lumens that are biaxially oriented in relation to each other, meaning that their lumen cross-sectional areas do not overlap but rather are side by side, and at least a distal shaft comprising at least two lumens that are coaxially oriented in relation to each other, meaning that a cross-sectional area of an inner lumen is completely circumscribed within a cross-section area of an outer lumen cross sectional area as a “tube within a tube”.
  • said transition comprises a taper between a proximal biaxial segment and a distal coaxial segment, said transition having a first larger O.D. proximally and a second smaller O.D. distally.
  • said proximal biaxial segment has an O.D. of substantially between 3 and 5 French, or between 4 and 5 French, or between 4.5 and 5 French
  • said distal coaxial segment has an O.D.
  • said transition comprises a length of between 1 mm and 75 cm, or between 1 mm and 30 mm.
  • shaft diameters in the typical range known in the art, for example, between 2 French and 10 French.
  • a transition from biaxial to coaxial configuration may entail thinning of a wall of a lumen, for example, said biaxial lumens may have thicker walls than said coaxial lumens, in an exemplary embodiment.
  • said transition is disposed more distally than proximally, however, those familial’ with the art will appreciate that a transition may be located anywhere between said hub end and said expansile balloon.
  • said at least two lumens can have many different cross-sectional shapes, for example, a biaxial configuration may comprise lumens with cross-sections that are generally circular or not circular.
  • biaxial lumens can have cross-sections that are generally ovals, semi-circles, D-shaped, or crescents, and oval, semi-circular, D-shaped, crescent or other cross-section configurations can offer functional advantages as readily known to those familiar with the art.
  • the transition between biaxial and coaxial lumen configurations is facilitated by a reduction in the caliber of the O.D. of the catheter shaft comprising reduction of the inner diameter (I.D.) and O.D. of said first lumen from said proximal biaxial segment as said proximal biaxial segment passes distally within a transition segment, said reduction of I.D. and O.D. of said biaxial segment facilitating envelopment of said first lumen by said second lumen in a transition to said distal coaxial segment.
  • said reduction of a first lumen I.D. in a distal coaxial segment would be small enough to accommodate a guidewire, but not large enough to accommodate substantial injection around said guidewire.
  • said I.D. could be less than 2/1000 of an inch larger than said guidewire in said distal coaxial segment.
  • an exemplary method of manufacture of said transition segment in an angioplasty balloon catheter from said proximal biaxial configuration to said distal coaxial configuration is to form a proximal biaxial catheter segment so that said first lumen migrates toward a central location of said second lumen as it moves away from said proximal biaxial segment within said transition segment towards said distal coaxial segment, in one exemplary embodiment also comprising a reduction in its O.D., and expanding an angular circumference of said second lumen so that it wraps substantially around said first lumen.
  • said transition segment comprises a heat weld between said proximal biaxial segment and said distal coaxial segment, said heal weld being achieved with the use of mandrels to preserve lumen shapes as required, in particular a tapered mandrel would be used to preserve a configuration of said first lumen throughout a transition from said proximal biaxial segment to said distal coaxial segment such that guidewire passage is facilated.
  • a proximal biaxial catheter segment may comprise a stiffening member, such as a core wire or hypotube, to impart stiffness to said proximal biaxial segment, to confer rigidity to the overall proximal biaxial segment and oppose a tendency in the body for a catheter to kink, bend so that it assumes a spiral course in a blood vessel such as an aorta, or fold over on itself rather than tracking and advancing in a linear manner.
  • a stiffening member may be integral to said proximal biaxial segment, irreversibly adherent to it.
  • said stiffening member may be contained within said proximal biaxial catheter segment but reversibly attached and removable from it.
  • a transition segment comprises a region of overlap between a guidewire in situ throughout a guidewire lumen in said distal coaxial segment and a stiffening member contained in a proximal biaxial segment, said proximal biaxial segment also comprising sufficient lumen diameter to simultaneously accommodate fluid injection therethrough while said stiffening member is in place within the same lumen.
  • Said overlap of said guidewire and said stiffening member over at least 1 mm in length would provide continuous stiffness throughout a catheter working length, thereby reducing the likelihood of catheter kinking during use, particularly at said transition segment, which might be vulnerable to said kinking if a caliber change was present therein.
  • a region of overlap between a guidewire used in a distal coaxial segment in a rapid exchange configuration and a stiffener in a proximal biaxial segment could occur in a distal portion of said proximal biaxial segment, if a guidewire port for exit of said guidewire were located in said proximal biaxial segment.
  • an angioplasty balloon catheter has a “rapid exchange” configuration. That is, the catheter has a guidewire lumen that does not extend throughout substantially all of the catheter, but rather extends from a distal catheter tip proximally and then exits a side wall of said catheter through a guidewire port located between a distal tip end and a proximal hub end, generally disposed more toward a distal end than a proximal end, generally but not necessarily between an angioplasty balloon and a middle of a catheter working length.
  • a guidewire lumen may be between 5 cm and 100 cm in length, or in other embodiments between 5 and 10 cm, 5 and 20 cm, 5 and 50 cm, or 5 and 75 cm in length.
  • a catheter working length is extra long to enable angioplasty procedure to be performed from virtually any access point in a vascular system, for example, angioplasty of arteries distal to a knee joint performed by a radial artery access point.
  • a catheter working length may be bctwcc 200 and 360 cm.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 clement 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 bi
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • said first lumen diameter could also taper in some exemplary embodiments between a proximal biaxial segment and a distal coaxial segment.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 guide wire port 11 in a side wall of said catheter .
  • 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.
  • 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.
  • 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.
  • 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.

Landscapes

  • Health & Medical Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Anesthesiology (AREA)
  • Child & Adolescent Psychology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Vascular Medicine (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention concerne le domaine des dispositifs médicaux, à savoir des cathéters à ballonnet d'angioplastie. Les modes de réalisation concernent un cathéter à ballonnet d'angioplastie qui présente des caractéristiques favorables à la fois de configurations de lumière biaxiale et coaxiale, telles que la capacité de poussée, le couple et la traçabilité, activées par une transition entre un segment de cathéter biaxial et un segment de cathéter coaxial. Dans un mode de réalisation donné à titre d'exemple, une configuration de lumière biaxiale-coaxiale permet l'injection de fluides à travers le cathéter et hors du cathéter à proximité de son extrémité de pointe distale avec un fil-guide en place dans le cathéter.
PCT/US2024/013759 2023-02-06 2024-01-31 Cathéter à ballonnet d'angioplastie comprenant une transition biaxiale-coaxiale Ceased WO2024167735A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US18/106,262 US20230191092A1 (en) 2020-05-05 2023-02-06 Angioplasty balloon catheter comprising a biaxial-coaxial transition
US18/106,262 2023-02-06

Publications (1)

Publication Number Publication Date
WO2024167735A1 true WO2024167735A1 (fr) 2024-08-15

Family

ID=92263371

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2024/013759 Ceased WO2024167735A1 (fr) 2023-02-06 2024-01-31 Cathéter à ballonnet d'angioplastie comprenant une transition biaxiale-coaxiale

Country Status (1)

Country Link
WO (1) WO2024167735A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5769814A (en) * 1994-03-31 1998-06-23 Leocor, Inc. Coaxial/double lumen catheter
US5879324A (en) * 1997-03-06 1999-03-09 Von Hoffmann; Gerard Low profile catheter shaft
US20190083757A1 (en) * 2014-09-04 2019-03-21 Abbott Cardiovascular Systems Inc. Balloon catheter
CN209392561U (zh) * 2018-10-10 2019-09-17 上海康德莱医疗器械股份有限公司 一种药物注入球囊导管
US20230191092A1 (en) * 2020-05-05 2023-06-22 Summa Therapeutics, Llc Angioplasty balloon catheter comprising a biaxial-coaxial transition

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5769814A (en) * 1994-03-31 1998-06-23 Leocor, Inc. Coaxial/double lumen catheter
US5879324A (en) * 1997-03-06 1999-03-09 Von Hoffmann; Gerard Low profile catheter shaft
US20190083757A1 (en) * 2014-09-04 2019-03-21 Abbott Cardiovascular Systems Inc. Balloon catheter
CN209392561U (zh) * 2018-10-10 2019-09-17 上海康德莱医疗器械股份有限公司 一种药物注入球囊导管
US20230191092A1 (en) * 2020-05-05 2023-06-22 Summa Therapeutics, Llc Angioplasty balloon catheter comprising a biaxial-coaxial transition

Similar Documents

Publication Publication Date Title
US5658251A (en) Intravascular catheter with distal guide wire lumen and transition member
US6004291A (en) Intravascular catheter with distal guide wire lumen and transition
US6821287B1 (en) Multi-mode vascular catheter system
US5045061A (en) Balloon catheter and locking guidewire system
US5195971A (en) Perfusion type dilatation catheter
US5261879A (en) Coaxial/side-by-side lumen perfusion dilatation catheter
US6027475A (en) Catheter shaft with an oblong transverse cross-section
US8267886B2 (en) Catheter having a core wire and a low profile bond
US5496275A (en) Low profile dilatation catheter
US5462530A (en) Intravascular catheter with bailout feature
US5047045A (en) Multi-section coaxial angioplasty catheter
US5730734A (en) Catheter systems with interchangeable parts
US5613949A (en) Double balloon catheter assembly
US5833706A (en) Single operator exchange perfusion catheter having a distal catheter shaft section
EP0580845B1 (fr) Catheter intravasculaire comportant un passage de fil de guidage distal
US5868706A (en) Catheter with reinforced oblong transverse cross section
EP0590140B1 (fr) Catheter de dilatation extra-plat
US20030065353A1 (en) Radially-expandable tubular elements for use in the construction of medical devices
US7189215B2 (en) Catheter with full-length core wire shaft for core wire interchangeability
US20040092868A1 (en) Catheter with full-length core wire shaft for core wire interchangeability
US20070167877A1 (en) Medical catheters and methods
US20230191092A1 (en) Angioplasty balloon catheter comprising a biaxial-coaxial transition
WO2024167735A1 (fr) Cathéter à ballonnet d'angioplastie comprenant une transition biaxiale-coaxiale
JP2002253678A (ja) 医療用バルーンカテーテル
US20250177706A1 (en) Angioplasty balloon catheter comprising a variable diameter shaft

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 24753809

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE