US20150105722A1 - Balloon catheter with floating hub - Google Patents

Balloon catheter with floating hub Download PDF

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Publication number
US20150105722A1
US20150105722A1 US14/383,774 US201314383774A US2015105722A1 US 20150105722 A1 US20150105722 A1 US 20150105722A1 US 201314383774 A US201314383774 A US 201314383774A US 2015105722 A1 US2015105722 A1 US 2015105722A1
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Prior art keywords
balloon
catheter
shaft
longitudinal direction
paragraph
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Abandoned
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US14/383,774
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English (en)
Inventor
Pat Byrne
Angela Kay Jensen
Andrew Schaffer
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ClearStream Technologies Ltd
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ClearStream Technologies Ltd
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Priority to US14/383,774 priority Critical patent/US20150105722A1/en
Publication of US20150105722A1 publication Critical patent/US20150105722A1/en
Abandoned legal-status Critical Current

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    • 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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub
    • 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
    • A61M25/1006—Balloons formed between concentric tubes
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • 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
    • A61M2025/1079—Balloon catheters with special features or adapted for special applications having radio-opaque markers in the region of the balloon

Definitions

  • This disclosure relates generally to catheters for performing medical procedures, such as balloon angioplasty and, more particularly, to a catheter including a floating hub, which may be used for ensuring the proper alignment between a radiopaque identifier and a portion of the balloon, such as the working surface.
  • Balloons are routinely used to resolve or address flow restrictions or perhaps even complete blockages in tubular areas of the body, such as arteries or veins. In many clinical situations, the restrictions are caused by hard solids, such as calcified plaque, and require the use of high pressures to compact such blockages.
  • Commercially available balloons employ complex technology to achieve high pressure requirements without sacrificing the profile of the balloon. Besides high pressure requirements, the balloons should also be resistant to puncture, easy to track and push, and present a low profile, especially when used for angioplasty.
  • angioplasty balloons are expanded from a deflated, folded state to an expanded state within a vessel to treat a target area, such as a portion of the circumferential inner wall I of a blood vessel V, as shown in FIGS. 1 and 2 .
  • the inflation of a balloon 12 with wall 28 is traditionally completed using an X-ray contrast agent CM along dimension DX to provide better visibility under X-ray or other form of radiography R during the interventional procedure, as illustrated in FIGS. 3 and 3 a (which shows the intensity measured by a fluoroscope detector plate, FDP).
  • FDP fluoroscope detector plate
  • a 70/30 percent mixture of contrast agent and saline is used to inflate the balloon during an angioplasty procedure.
  • a desirable goal is to reduce inflation and deflation times required for balloons without sacrificing the profile of the balloons, especially for large volume balloons (which can require up to two minutes of inflation/deflation times with the contrast agent).
  • the use of contrast agent prolongs the inflation/deflation times and also poses the risk of iodine exposure to patients sensitive to iodine.
  • a non-radiopaque substance could be used in lieu of the contrast agent, such as for example saline or carbon dioxide, but such substances are invisible during X-ray imaging, and thus do not enhance visibility.
  • the physician performing the angioplasty procedure should be able to locate the position of the uninflated balloon with accuracy, so that the balloon will be properly positioned once inflated. This is conventionally accomplished by attaching marker bands on the catheter shaft in the region corresponding to the balloon working surface.
  • This “working surface” is the surface along the portion of the balloon that is used to achieve the desired treatment effect, such as contacting the calcified plaque (which surface in the case of a balloon having conical or tapering sections at the proximal and distal ends is typically co-extensive with a generally cylindrical barrel section).
  • misalignment amount X between each interior marker band M carried by shaft S and working surface W of balloon 12 which also typically includes a radiopaque tip P at the distal end.
  • misalignment amount X between each interior marker band M carried by shaft S and working surface W of balloon 12 , which also typically includes a radiopaque tip P at the distal end.
  • the resulting misalignment may prevent the clinician from accurately identifying the location of the working surface of the balloon during an interventional procedure. This may lead to a geographic misplacement, or “miss,” of the intended contact between the target area T and the working surface W of the balloon 12 (see FIG. 2 ). It is especially desirable to avoid such an outcome when the balloon is designed to deliver a payload (such as a drug, stent, or both) or a working element to a specified location within the vasculature, since a miss may prolong the procedure (such as, for example, by requiring redeployment of the balloon 12 or the use of another balloon catheter in the case of a drug coated balloon).
  • a payload such as a drug, stent, or both
  • the balloon may also be subject to a phenomenon known as “pancaking.” In this condition, the balloon 12 folds down upon itself to a flattened state, as shown in FIG. 5 . This situation may cause the balloon to be viewed through fluoroscopy as perhaps still being in the inflated condition, since the full width of the balloon may still be perceived. This can give the clinician the false perception that the balloon remains inflated, when in fact it is not.
  • the need is identified for a balloon for which the working surface may be identified during an interventional procedure with enhanced precision.
  • the solution would take into account the possible mismatch between fixed locations on the catheter shaft and the balloon to define the working surface.
  • the improved identification may also allow for the better detection of the false perception of deflation caused by pancaking.
  • procedural efficiency would be enhanced without remarkably increasing cost or complexity, and in a manner that can be applied to many existing catheter technologies without extensive modification.
  • An object of the disclosure is to provide a balloon for which the working surface may be identified during an interventional procedure with enhanced precision.
  • FIGS. 1-9 are illustrative of the background of the invention.
  • FIG. 10 illustrates a first embodiment according to the disclosure
  • FIG. 11 illustrates a second embodiment according to the disclosure
  • FIGS. 12 and 13 are partial views of the FIG. 11 embodiment
  • FIGS. 14 and 15 illustrate additional aspects of the disclosure
  • FIG. 15 illustrates the embodiment of FIG. 14 in a folded condition
  • FIGS. 16 and 17 illustrate a further embodiment according to the disclosure.
  • a catheter 10 having a distal portion 11 with a balloon 12 mounted on a catheter tube 14 .
  • the balloon 12 has an intermediate section 16 , or “barrel,” and end sections 18 , 20 .
  • the end sections 18 , 20 reduce in diameter to join the intermediate section 16 to the catheter tube 14 (and thus sections 18 , 20 are generally termed cones or cone sections).
  • the balloon 12 is sealed at balloon ends (proximal end 15 a and distal end 15 b ) on the cone sections 18 , 20 to allow the inflation of the balloon 12 via one or more inflation lumens 17 extending within catheter tube 14 and communicating with the interior of the balloon 12 .
  • the catheter tube 14 also includes an elongated, tubular shaft 24 forming a guidewire lumen 23 that directs the guidewire 26 through the catheter 10 , and along the distal end of which the balloon 12 may be located.
  • this guidewire 26 may extend through the proximal end of the catheter 10 and a first port 25 of a connector 27 into the lumen 23 to achieve an “over the wire” (OTW) arrangement, but could also be provided in a “rapid exchange” (RX) configuration, in which the guidewire 26 exits a lateral opening 14 a closer to the distal end (see FIG. 9 ) or else is fed through the tip distally of the balloon 12 (not shown).
  • a second port 29 may also be associated with catheter 10 , such as by way of connector 27 , for introducing a fluid (e.g., saline, a contrast agent, or both) into the interior compartment of the balloon 12 via the inflation lumen 17 .
  • a fluid e.g., saline, a contrast agent
  • Balloon 12 may include a single or multi-layered balloon wall 28 forming the interior for receiving the inflation fluid.
  • the balloon 12 may be a non-compliant balloon having a balloon wall 28 that maintains its size and shape in one or more directions when the balloon is inflated. Examples of non-compliant balloons may be found in U.S. Pat. No. 6,746,425 and Publication Nos. US 2006/0085022, US 2006/0085023 and US 2006/0085024, the disclosures of which are hereby incorporated herein by reference.
  • the balloon 12 in such case also has a pre-determined surface area that remains constant during and after inflation, also has a pre-determined length and pre-determined diameter that each, or together, remain constant during and after inflation.
  • the balloon 12 could be semi-compliant or compliant instead, depending on the particular use.
  • the catheter 100 includes a seal 102 , such as may be provided by one or more O-rings or the like, at or near a proximal end of the inner shaft 24 .
  • the seal 102 is adapted for positioning in a recess 104 formed in a receiver 101 for receiving the shaft 24 , such as hub 106 , which is shown as being oversized for purposes of illustration.
  • the recess 104 is oversized so as to allow movement of the seal 102 and thus shaft 24 relative to the tube 14 within inflation lumen 17 , which is in turn connected to the proximal end of the balloon 12 .
  • the shaft 24 is not connected to any other structure in the catheter 10 , and thus can move to and fro a distance in the longitudinal direction corresponding to the length of the recess 104 .
  • the balloon 12 may include a radiopaque identifier separate from the shaft 24 to allow for identification of a particular location under fluoroscopy.
  • this identifier is provided in the form of an insert 44 .
  • This insert 44 may be tubular in form, and extend in a spaced apart manner along and generally coaxially with the shaft 24 extending through the interior compartment of the balloon 12 , thus forming a sleeve.
  • a free end portion 44 a of the insert 44 is located at a position aligned with the edge or extent of the working surface W at the proximal end 15 a , while the opposite, fixed end portion 44 b is connected to the balloon 12 , such as at the point where it attaches to the tube 14 at this proximal end.
  • the connection between the insert 44 and the balloon 12 , tube 14 , or both, may be one or more of an interference fit, bonding (using an adhesive, welding, etc.), friction, or other like manners of forming a secure arrangement that does not permit relative movement of two distinct parts when connected.
  • the insert 44 may also be adapted so as to minimize interference with the inflation of the balloon 12 .
  • the insert 44 may be provided with one or more perforations 45 . These perforations 45 prevent the insert 44 from serving as a barrier that would retard the inflation fluid emanating from the tube 14 from readily flowing into the interior compartment of the balloon 12 , and thus help to preserve the desired short inflation times. Indeed, the presence of such perforations 45 may allow the inserts 44 and 46 to be combined into a single unitary piece of material extending continuously between the proximal and distal ends 15 a , 15 b of the balloon 12 .
  • a second, at least partially radiopaque insert 46 may also be provided at the distal end 15 b including the conical section 20 .
  • this insert 46 is arranged at the location where the distal end 15 b of the balloon 12 is secured to the shaft 24 to form the tip P (which as noted may also be radiopaque).
  • this insert 46 may be connected to the shaft 24 , or may be embedded within the material forming the corresponding distal end 15 b of the balloon 12 (especially if a multi-layered arrangement is used to form the balloon wall 28 ).
  • the proximal end portion 46 a of the insert 46 terminates at the distal edge of the working surface W, so as to assist in the identification process.
  • the proximal end portion 46 a of this insert 46 extending within the interior compartment of the balloon 12 may be spaced from the shaft 24 (note gap 47 in FIG. 15 ) so as to be less susceptible to any misalignment caused by bending.
  • This end 46 a may be partially or entirely radiopaque. This radiopaque end portion 46 a provides an indication of the distance between the distal edge of the working surface W and the distal end 15 b of the balloon 12 .
  • the distal end portion 46 b of the insert 46 may be formed with the tip P as a unitary, continuously radiopaque structure (for example, with different radiopaque qualities (patterns, shapes, densities, etc.)), if desired to allow for ready identification of these components.
  • the seal 102 provides the desired closed lumen 17 to receive the inflation fluid.
  • any tendency of the shaft 24 to bend and cause misalignment has no impact on the location of the radiopaque identifier, such as inserts 44 , 46 .
  • the insert 44 at the proximal end 15 a is separate from the shaft 24 , and the insert 46 at the distal end 15 b of the balloon 12 may move along with the shaft 24 , which is free to move in the longitudinal direction until the seal 102 reaches the distal end of the recess 104 (note position 102 ′ in FIG. 17 ).
  • Balloons 12 that carry one or more surface elements, such as a payload (drug, stent, or both) or a working implement (cutter, focused force wire, or the like) into the vasculature may also benefit from the foregoing description of marking techniques.
  • a balloon 12 including a defined working surface W may include a portion coated with such a drug D, such as one designed for achieving a desired therapeutic effect when applied to the interior of the vessel.
  • the drug D may be applied to the inflated balloon as part of the manufacturing process, and prior to folding for insertion in the vasculature.
  • the clinician may thus with the benefit of a fluoroscope determine the precise positioning of the working surface W prior to inflating the balloon 12 in the vasculature to deliver the drug D to the desired location and provide the desired treatment regimen.
  • a balloon catheter for use with a guidewire comprising:
  • the catheter of item 2 further including a tube for supplying an inflation fluid to inflate the balloon, said tube being connected to the receiver and generally coaxial with the shaft, and wherein the stop forms a seal with the recess to prevent the inflation fluid from passing around the shaft.
  • radiopaque identifier comprises an insert positioned within the interior compartment of the balloon.
  • the insert comprises a first insert at a proximal end of the balloon and a second insert at a distal end of the balloon.
  • a hub for a balloon catheter having an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, and an inflatable balloon connected to the distal end of the shaft for being inflated by an inflation fluid, comprising:
  • the hub of item 10 wherein the body includes a guidewire port arranged in communication with the receiver, and further including an inflation port for introducing the inflation fluid for inflating the balloon.
  • the catheter of any of the foregoing items 1 to 9, comprising a hub for receiving a proximal end of a guidewire shaft, the shaft being adapted to slidably move in a restrained manner relative to the hub.
  • a catheter comprising a hub for receiving a proximal end of a guidewire shaft, the shaft being adapted to slidably move in a restrained manner relative to the hub.
  • the catheter of item 1 including a guidewire shaft having a distal end connected to a balloon and at a proximal end mounted for sliding movement.
  • the balloon catheter of item 1 or 2 for use with a guidewire comprising:
  • the catheter of item 4 further including a tube for supplying an inflation fluid to inflate the balloon, said tube being connected to the receiver and generally coaxial with the shaft, and wherein the stop forms a seal with the recess to prevent the inflation fluid from passing around the shaft.
  • radiopaque identifier comprises an insert positioned within the interior compartment of the balloon.
  • the insert comprises a first insert at a proximal end of the balloon and a second insert at a distal end of the balloon.
  • a hub for a balloon catheter having an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, and an inflatable balloon connected to the distal end of the shaft for being inflated by an inflation fluid, comprising:
  • the hub of item 13 wherein the body includes a guidewire port arranged in communication with the receiver, and further including an inflation port for introducing the inflation fluid for inflating the balloon.
  • the receiver further includes a recess for receiving the stop, said recess having a dimension in the longitudinal direction that is greater than a corresponding dimension of the stop.
  • a catheter including a guidewire shaft having a distal end connected to a balloon and at a proximal end mounted for sliding movement.
  • the catheter of item 1 comprising a hub for receiving a proximal end of a guidewire shaft, the shaft being adapted to slidably move in a restrained manner relative to the hub.
  • the balloon catheter of item 1 or 2 for use with a guidewire comprising:
  • the catheter of item 4 further including a tube for supplying an inflation fluid to inflate the balloon, said tube being connected to the receiver and generally coaxial with the shaft, and wherein the stop forms a seal with the recess to prevent the inflation fluid from passing around the shaft.
  • radiopaque identifier comprises an insert positioned within the interior compartment of the balloon.
  • the insert comprises a first insert at a proximal end of the balloon and a second insert at a distal end of the balloon.
  • a hub for a balloon catheter having an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, and an inflatable balloon connected to the distal end of the shaft for being inflated by an inflation fluid, comprising:
  • the hub of item 13 wherein the body includes a guidewire port arranged in communication with the receiver, and further including an inflation port for introducing the inflation fluid for inflating the balloon.
  • the receiver further includes a recess for receiving the stop, said recess having a dimension in the longitudinal direction that is greater than a corresponding dimension of the stop.
  • a balloon catheter comprising: an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end; and an inflatable balloon supported along the distal end of the shaft, the balloon when inflated including first and second spaced conical end sections and a working surface between the conical sections, the balloon further including at least one radiopaque marking identifying the transition from the conical end section to the working surface.
  • the at least one radiopaque marking comprises a first radiopaque marking at a first transition between the first conical end section and the working surface, and further including a second radiopaque marking at a second transition between the second conical end section and the working surface.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the at least one marking comprises a strip.
  • the strips extend at least partially in a longitudinal direction between the first and second conical end sections.
  • the strips comprise annular bands.
  • at least two spaced radiopaque markings are provided on each conical end section, including one adjacent a distal portion and a proximal portion of each conical end section.
  • the balloon includes a barrel section between the first and second conical end sections, and further including a plurality of radiopaque markings on the barrel section.
  • the marking comprises a first pattern on the conical end sections and further including a second, different pattern on the working surface.
  • the at least one marking is selected from the group consisting of a pattern, a strip, a brand, a logo, a letter, a number, a word, or combinations thereof.
  • the identifier comprises a scale.
  • the balloon includes a drug. 1.13 The catheter of paragraph 1.12, wherein the drug corresponds to the location of the radiopaque marking. 1.14 The catheter of paragraph 1.12, wherein the drug corresponds to other than the location of the radiopaque marking. 1.15 The catheter of paragraph 1.12, wherein the radiopaque marking comprises the drug formulated to include a radiopacifier. 1.16 A balloon having a drug carried on a working surface of the balloon wall and a radiopaque identifier identifying the location of the drug on the balloon. 1.17 The balloon of paragraph 1.16, wherein the radiopaque identifier comprises a radiopaque material mixed with a formulation comprising the drug.
  • a balloon catheter comprising: an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end; and an inflatable balloon supported along the distal end of the shaft, the balloon when inflated including a generally cylindrical barrel section forming a working surface, and generally conical end sections that do not form a part of the working surface, the balloon further including at least one radiopaque identifier for indicating the relative position of the working surface, said identifier being provided on at least one of the conical end sections of the balloon so as to define the extent of the working surface.
  • the identifier comprises a marking.
  • a first marking is provided at a first transition between the first conical section end section and the working surface and a second marking is provided at a second transition between the second end section and the working surface.
  • the marking comprises a strip.
  • the identifier comprises a longitudinal strip extending between an end of the balloon and the barrel section.
  • each of the plurality of identifiers comprises a longitudinally extending strip.
  • the identifiers comprise annular bands.
  • the identifier is a first identifier comprising a first pattern, and further including a second identifier comprising a second, different pattern.
  • the identifier includes at least one letter or number.
  • the identifier comprises a logo.
  • the identifier comprises a scale.
  • An inflatable balloon for use in connection with a catheter, comprising: an inflatable body including a working surface extending in a longitudinal direction between a first end and a second end, the body having at least one radiopaque identifier provided along the body for identifying at least a first end of the working surface, the radiopaque identifier having a first radiographic quality for identifying the location of the first end of the working surface and a second radiographic quality at a location other than at the first end of the working surface.
  • the second radiographic quality is provided for identifying the second end of the working surface.
  • the first radiographic quality and the second radiographic quality are substantially the same.
  • the radiopaque identifier comprises a marking.
  • the radiopaque identifier follows a generally helical path from the first end to the second end of the working surface.
  • the identifier comprises a plurality of helical identifiers extending along the working surface.
  • the identifier comprises a radiopaque filament.
  • a balloon for use in connection with a catheter comprising: a body having an outer surface and at least one winding extending along the outer surface of the balloon, said balloon having a radiopaque quality. 3.17 The balloon of paragraph 3.16, wherein the winding comprises a radiopaque filament. 3.18 The balloon of any of the foregoing paragraphs, wherein the radiopaque identifier comprises a helical pattern or a diamond pattern. 3.19 A catheter including the balloon of any of the foregoing paragraphs. 3.20 An inflatable balloon for use in connection with a catheter comprising a radiopaque identifier comprising a helical pattern or a diamond pattern.
  • a balloon catheter for use in connection with a guidewire comprising: an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end; an inflatable balloon supported along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends; and at least one wire including at least a radiopaque portion for identifying the location of working surface of the balloon.
  • said wire comprises a material having a shape memory for adjusting between a first state and a second state.
  • the at least one wire extends generally in the longitudinal direction.
  • a balloon catheter adapted for use with a guidewire comprising: an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end; an inflatable balloon supported along the distal end of the shaft, the balloon when inflated including first and second spaced ends and a working surface between the ends; and an insert located within the interior compartment of the balloon, the insert including at least a radiopaque portion separate from the shaft.
  • the insert is adapted for moving relative to the shaft.
  • the insert extends from a first end of the balloon to one end of the working surface.
  • the insert comprises a tube made at least partially of a radiopaque material.
  • the insert comprises at least one finger.
  • the finger includes a radiopaque end portion.
  • the insert comprises a plurality of fingers adapted for moving from a retracted condition to an expanded condition when the balloon is inflated. 5.8 The catheter of any of the foregoing paragraphs 5.1 to 5.7, further including a retractable sheath at least partially covering the insert.
  • the insert comprises a wire.
  • the wire includes a radiopaque portion corresponding to the working surface.
  • the radiopaque portion comprises an intermediate portion of the wire.
  • the wire extends from the first end to the second end of the balloon, and the radiopaque portion comprises an end portion of the wire.
  • at least one end of the insert is connected at a location where the balloon connects to the tubular shaft.
  • a balloon catheter comprising: an elongated, tubular shaft having a proximal end and a distal end; and a balloon positioned along the distal end of the shaft, a portion of a wall of the balloon partially comprising a coextruded radiopaque material.
  • the radiopaque portion comprises at least one strip extending along a working surface of the balloon.
  • a balloon catheter comprising: a shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, and supporting at least one radiopaque identifier; an inflatable balloon supported along the distal end of the shaft, the balloon when inflated including a working surface; and an actuator for aligning at least one end of the working surface with the at least one radiopaque identifier.
  • the actuator includes a first position corresponding to a deflated state of the balloon and a second position corresponding to the inflated state of the balloon.
  • the actuator comprises a spring.
  • the radiopaque identifier comprises a marker attached to the shaft.
  • the radiopaque identifier comprises an insert positioned within the interior compartment of the balloon.
  • the actuator is a first actuator for aligning a distal end of the working surface with the radiopaque identifier, and further including a second actuator for aligning a proximal end of the working surface with the radiopaque identifier.
  • each of the first and second actuators comprise a plurality of springs.
  • the radiopaque identifier comprises a first marking and a second marking
  • the actuator is a first actuator for aligning a distal end of the working surface with the first marking, and further including a second actuator for aligning a proximal end of the working surface with the second marking.
  • the balloon catheter of any of the foregoing paragraphs 8.1 to 8.14 comprising: a shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end, and supporting first and second radiopaque identifiers; a first actuator for aligning a first end of the working surface with the first radiopaque marking; and a second actuator for aligning a second end of the working surface with the second radiopaque identifier.
  • the balloon catheter of any of the foregoing paragraphs 8.1 to 8.15 comprising: a shaft for carrying the balloon, the shaft including at least one channel formed in an outer portion of a wall of the shaft; and an actuator having a first end connected to the balloon and a second end at least partially positioned in the channel.
  • the balloon catheter of any of the foregoing paragraphs 8.1 to 8.16 comprising: a shaft for carrying the balloon, the shaft including a plurality of channels formed in an outer portion of the wall of the shaft. 8.18 The catheter of paragraph 8.17, further including an actuator having a first end connected to the balloon and a second end positioned in at least one of the channels.
  • a balloon catheter for use with a guidewire comprising: an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end; an inflatable balloon connected to the distal end of the shaft, the balloon including a working surface; a radiopaque identifier for identifying the working surface; and a receiver adjacent the proximal end of the shaft and adapted for allowing the shaft to move relative to the receiver in at least the longitudinal direction.
  • the shaft carries a stop
  • the receiver further includes a recess for receiving the stop, said recess having a dimension in the longitudinal direction that is greater than a corresponding dimension of the stop.
  • the catheter of paragraph 9.2 further including a tube for supplying an inflation fluid to inflate the balloon, said tube being connected to the receiver and generally coaxial with the shaft, and wherein the stop forms a seal with the recess to prevent the inflation fluid from passing around the shaft.
  • the seal comprises an O-ring arranged coaxially with the shaft.
  • the radiopaque identifier is separate from the shaft.
  • the radiopaque identifier comprises an insert positioned within the interior compartment of the balloon.
  • the insert comprises a tubular sleeve arranged coaxially with the shaft.
  • the body includes a guidewire port arranged in communication with the receiver, and further including an inflation port for introducing the inflation fluid for inflating the balloon.
  • the receiver further includes a recess for receiving the stop, said recess having a dimension in the longitudinal direction that is greater than a corresponding dimension of the stop.
  • the stop forms a seal with the recess to prevent the inflation fluid from passing.
  • the stop comprises an O-ring.
  • a catheter including a guidewire shaft having a distal end connected to a balloon and at a proximal end mounted for sliding movement.
  • a catheter comprising a hub for receiving a proximal end of a guidewire shaft, the shaft being adapted to slidably move in a restrained manner relative to the hub.
  • a balloon catheter comprising: an elongated tubular shaft having a proximal end and a distal end spaced apart in a longitudinal direction, the shaft along a distal portion including at least one radiopaque identifier, said distal portion being formed of a material resistant to elongation in the longitudinal direction; and an inflatable, non-compliant balloon extending over the distal portion of the shaft.
  • the balloon includes a generally cylindrical barrel section positioned between generally conical sections, said barrel section including a working surface having at least one edge aligned with the radiopaque identifier.
  • the radiopaque identifier comprises a first marker positioned at the at least one edge of the working surface, and further including a second marker positioned at the opposite edge of the working surface in the longitudinal direction.
  • each marker comprises a radiopaque band swaged to the distal portion of the shaft.
  • the distal portion of the shaft comprises a tube adapted for guiding a guidewire from a proximal end of the balloon to a distal end of the balloon.
  • 10.6 The catheter according to paragraph 10.1, wherein at least the distal portion of the shaft comprises steel.
  • the shaft comprises steel.
  • 10.8 The catheter according to paragraphs 10.6 or 10.7, wherein the steel shaft comprises a stainless steel. 10.9
  • the polymer layer comprises an outer layer of the shaft.
  • the distal portion of the shaft comprises a polymer shaft including a braid or mesh.
  • the balloon includes a generally cylindrical barrel section positioned between generally conical sections, the distal portion of the shaft extending from a first end of a first conical section to a second end of a second conical section.
  • the non-compliant balloon comprises one or more inelastic fibers.
  • the non-compliant balloon comprises polyethylene terephthalate.
  • a balloon catheter comprising: a shaft extending in a longitudinal direction and adapted for expanding from a compressed condition to an expanded condition in the longitudinal direction, the shaft supporting at least one radiopaque identifier; and an inflatable balloon positioned along the shaft, the balloon when inflated including a working surface for aligning with the radiopaque identifier in at least the expanded condition of the shaft.
  • the expandable shaft comprises a first portion connected in tandem to an expandable element.
  • the expandable element comprises a spring.
  • the spring comprises a coil spring.
  • the expandable shaft comprises a first expandable element connecting a first portion of the shaft to a second portion of the shaft, and further including a second expandable element connecting the second portion of the shaft to a third portion of the shaft.
  • the first and second expandable elements comprise first and second coil springs.
  • the first and second coil springs have different spring constants.
  • the radiopaque identifier comprises a pair of spaced radiopaque markers, one positioned in alignment with a first end of the working surface and another positioned at a second end of the working surface.
  • the first and second expandable elements comprise a radiopaque material.
  • the radiopaque identifier comprises a spring.
  • the expandable element comprises a spring having a variable spring constant.
  • a balloon catheter comprising: a shaft; a balloon; and an expandable element adapted for expanding in the longitudinal direction connecting the shaft to the balloon.
  • the expandable element is selected from the group consisting of a spring, a bellows, a fiber matrix, or combinations of the foregoing.
  • a balloon catheter comprising a balloon and an inflation lumen including an expandable element adapted for expanding in the longitudinal direction for providing a fluid to the balloon.
  • the expandable element comprises a radiopaque material.
  • 11.30 The catheter of any of the foregoing paragraphs 11.1 to 11.29, further including a drug on the balloon.
  • a balloon catheter comprising: an elongated, tubular shaft extending in a longitudinal direction, said shaft having a proximal end and a distal end; and a balloon having an inflation compartment formed a balloon wall including a working surface, and further including at least one chamber adjacent to the working surface adapted for receiving an identifier for identifying the location of the working surface.
  • 12.2 The balloon catheter of paragraph 12.1, wherein the shaft includes a first lumen for supplying a fluid to the chamber.
  • the shaft includes a port between the first lumen and the chamber.
  • the identifier comprises a contrast agent.
  • the contrast agent comprises a material selected from the group consisting of a radiopacifier, polyvinyl acetate, cellulose, a fluid, a liquid, a solid, a powder, or combinations of the foregoing.
  • the chamber comprises a first chamber at a proximal end of the balloon, and further including a second chamber at a distal end of the balloon.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
US14/383,774 2012-03-09 2013-03-08 Balloon catheter with floating hub Abandoned US20150105722A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US14/383,774 US20150105722A1 (en) 2012-03-09 2013-03-08 Balloon catheter with floating hub

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201261608927P 2012-03-09 2012-03-09
NL2008453 2012-03-09
NL2008453 2012-03-09
PCT/US2013/029989 WO2013134702A1 (en) 2012-03-09 2013-03-08 Balloon catheter with floating hub
US14/383,774 US20150105722A1 (en) 2012-03-09 2013-03-08 Balloon catheter with floating hub

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2013/029989 A-371-Of-International WO2013134702A1 (en) 2012-03-09 2013-03-08 Balloon catheter with floating hub

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US16/133,251 Division US10994096B2 (en) 2012-03-09 2018-09-17 Balloon catheter with floating hub

Publications (1)

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US20150105722A1 true US20150105722A1 (en) 2015-04-16

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ID=49117406

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US14/383,774 Abandoned US20150105722A1 (en) 2012-03-09 2013-03-08 Balloon catheter with floating hub
US16/133,251 Active 2033-10-19 US10994096B2 (en) 2012-03-09 2018-09-17 Balloon catheter with floating hub
US17/242,726 Active 2033-06-22 US11878134B2 (en) 2012-03-09 2021-04-28 Balloon catheter with floating hub

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US16/133,251 Active 2033-10-19 US10994096B2 (en) 2012-03-09 2018-09-17 Balloon catheter with floating hub
US17/242,726 Active 2033-06-22 US11878134B2 (en) 2012-03-09 2021-04-28 Balloon catheter with floating hub

Country Status (10)

Country Link
US (3) US20150105722A1 (zh)
EP (2) EP2822629B1 (zh)
JP (1) JP6382112B2 (zh)
KR (1) KR20140133555A (zh)
CN (1) CN104245030B (zh)
AU (1) AU2013229831B2 (zh)
CO (1) CO7170134A2 (zh)
IN (1) IN2014DN07119A (zh)
MX (2) MX2014010837A (zh)
WO (1) WO2013134702A1 (zh)

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USD843573S1 (en) 2015-11-13 2019-03-19 Access Closure, Inc. Vascular closure apparatus
USD847988S1 (en) 2015-11-13 2019-05-07 Access Closure, Inc. Handle grip
US10456123B2 (en) 2014-11-14 2019-10-29 Access Closure, Inc. Apparatus and method for sealing a vascular puncture
USD865166S1 (en) 2015-11-13 2019-10-29 Access Closure, Inc. Sheath adapter
JPWO2019180928A1 (ja) * 2018-03-23 2021-03-11 朝日インテック株式会社 バルーンカテーテル

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WO2013134695A1 (en) 2012-03-09 2013-09-12 Clearstream Technologies Limited Medical balloon including radiopaque insert for precisely identifying a working surface location
US11357956B2 (en) 2012-03-09 2022-06-14 Clearstream Technologies Limited Parison for forming blow molded medical balloon with modified portion, medical balloon, and related methods
CN104884114B (zh) 2012-12-31 2020-05-22 明讯科技有限公司 具有有助于对准的标记的导管
JP7086089B2 (ja) * 2017-09-27 2022-06-17 テルモ株式会社 バルーンカテーテル

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CN104245030B (zh) 2018-03-02
US11878134B2 (en) 2024-01-23
EP3569279B1 (en) 2020-12-30
CO7170134A2 (es) 2015-01-28
WO2013134702A4 (en) 2013-10-10
MX2014010837A (es) 2015-06-03
AU2013229831A1 (en) 2014-09-25
US20190083744A1 (en) 2019-03-21
IN2014DN07119A (zh) 2015-04-24
JP6382112B2 (ja) 2018-08-29
EP2822629A1 (en) 2015-01-14
AU2013229831B2 (en) 2017-10-26
CN104245030A (zh) 2014-12-24
JP2015512696A (ja) 2015-04-30
KR20140133555A (ko) 2014-11-19
MX2020009591A (es) 2022-08-02
US10994096B2 (en) 2021-05-04
EP3569279A1 (en) 2019-11-20
EP2822629B1 (en) 2019-07-03
WO2013134702A1 (en) 2013-09-12

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