Abstract: Balloon catheter comprises an elongated shaft having a proximal end, a distal end, an inflation lumen extending therein, and a biaxially oriented nonporous thermoplastic polymer tubular member having a Shore durometer hardness of less than about 75D and having the inflation lumen therein. The balloon catheter also comprises a balloon sealing secured proximate the distal end of the shaft and having an interior in fluid communication with the inflation lumen.

Abstract: A catheter having an elongated shaft with a tubular member which forms at least a portion of the shaft and which is formed of a biaxially oriented thermoplastic polymeric material, and a method of forming the catheter shaft by radially and longitudinally expanding the tubular member to biaxially orient the polymeric material, and, in one embodiment, tapering the tubular member to form a bending stiffness transition. A catheter of the invention has an improved combination of low bending stiffness, high rupture pressure, and high tensile strength, for improved catheter performance.

Abstract: The present invention is a catheter device that includes a disruptable guidewire channel. The guidewire channel is configured to provide necessary trackability of the catheter along the guidewire during introduction of the catheter to a treatment site. Once treatment is completed, the guidewire channel can then be disrupted so as to free the guidewire from the catheter in situ. The apparatus of the present invention provides distinct advantages over existing over-the-wire and rapid exchange catheter introduction methods, including the ability to achieve much faster treatment implement exchanges, the ability to rapidly deliver multiple treatment implements in series, and the ability to maintain multiple treatment implements simultaneously at a treatment site using a single guidewire.

Abstract: Described is a method for treating a bronchial tissue. A guide wire is inserted through a bronchial passage to a desired location relative to a target portion of tissue to be treated. A catheter is slid along the guide wire with the guide wire received in a first lumen of the catheter until the guide wire exits a proximal port of the first lumen. A stiffening member is inserted into a second lumen of the catheter. A fluid is injected through the second lumen to a distal port of the catheter, so that the fluid is supplied to the bronchial tissue.

Abstract: A rapid exchange catheter has an outer conduit and a hollow inner conduit disposed in the lumen of the outer conduit. The inner conduit includes a distal part, a proximal part and a variable length sleeve member sealingly attached between the proximal part and distal part. The distal end of the distal part of the inner conduit extends beyond the distal end of the outer conduit. An inflatable balloon is sealingly attached to the distal end of the outer conduit and to the proximal part of the inner conduit. The balloon intussuscepts upon proximal movement of the distal part of the inner conduit. A pulling member is attached to the distal part of the inner conduit for moving the distal part of the inner conduit proximally to longitudinally shorten the sleeve member. A fluid port allows inflating and deflating the balloon.

Abstract: A balloon catheter for use alone or as a stent delivery system includes a balloon segment and a shaft segment having a varying flexibility. The shaft segment includes a polymer encased braid which extends along substantially the entire length of the shaft segment for added pushability and kink resistance. A flexible distal tip extends from the balloon for improved trackability.

Abstract: A rapid exchange catheter extends from a proximal portion which remains outside of a patient's body during use to a distal portion which, during use, is located within a body lumen adjacent to a target area to be treated, wherein the proximal and distal portions are coupled by a medial portion. The catheter comprises a guide wire lumen extending longitudinally through the distal portion and a guide wire receiving channel formed by an outer surface of the medial portion, wherein the guide wire lumen is open to a distal end of the channel.

Abstract: A guidewire exchange device is configured to exchange a guidewire associated with a guidewire port in a medical device. The guidewire exchange device is further configured to interface with the medical device at the guidewire port, remove the guidewire from the medical device, and insert a replacement guidewire.

Abstract: Rapid exchange angioplasty catheters and methods of constructing rapid exchange angioplasty catheters including features that provide good pushability and kink resistance. In an illustrative embodiment, a catheter is provided, the illustrative catheter including a proximal hypotube section, which connects to a more distal braided catheter section. The braided catheter section connects to a midshaft portion that includes a guidewire entry port. Distal of the midshaft portion is a distal section having a balloon disposed thereon. An inflation lumen extends the length of the catheter, while a guidewire lumen extends only from the guidewire entry port to the distal end of the catheter. Optionally, a core wire may extend across the joint from the hypotube, to the braided catheter section, and past the guidewire entry port.

Abstract: A system for treatment of a vessel bifurcation and its method of use comprises a catheter having a catheter shaft, a portion of which is characterized as an axle about which a rotatable assembly is disposed and rotatable thereabout. The system employs a series of lumens, openings and/or ports to provide a balloon mounted on the rotatable assembly with fluid communication to the catheter shaft.

Abstract: A medical device and method for the treatment of a sinus opening includes a handle, a guide catheter, a guide wire, a balloon catheter, a guide wire movement mechanism and a balloon catheter movement mechanism. The handle has proximal and distal ends and a longitudinal axis along the length of the handle. The guide catheter is attached to the distal end of the handle and has a catheter lumen. The guide wire and balloon catheter are both disposed at least partially in the handle and catheter lumen. The guide wire movement mechanism and the balloon catheter movement mechanism are both operatively disposed on the handle. In addition, the guide wire movement mechanism is configured for advancement and retraction of the guide wire through the handle and catheter lumen by user operation of the guide wire movement mechanism.

Abstract: A catheter is described herein, having a catheter shaft including a proximal end and a distal end, a tip attached to the distal end, including first and second legs spaced apart to form a slot therebetween, the slot in fluid communication with a lumen of the catheter shaft, and a bladder inflatable element positioned over an outer surface of at least one of the first and second legs.

Abstract: Medical device delivery systems, as well as related methods and components, are disclosed.

Abstract: The invention discloses a balloon catheter comprising a catheter shaft, at the distal end of which an inflatable balloon is arranged and at the proximal end of which a connecting piece is arranged, comprising a guiding wire which can be passed through a guiding wire lumen of the catheter shaft from the proximal end to the distal end and through the balloon and an inflation or deflation lumen extending from the proximal end of the catheter shaft to the balloon, wherein a portion of the catheter shaft having a selectable length and extending from the proximal end is provided with a metal reinforcing pipe.

Abstract: A medical balloon catheter including a shaft comprised of a cross-wound coil tube and a sleeve surrounding the cross-wound coil tube. The cross-wound coil tube includes a monofilament inner coil disposed within a monofilament outer coil. The inner and outer coils are wound in opposite pitch directions. In at least one embodiment, at least one of the inner and outer coils includes a tapered distal section having a tapered diameter. In at least another embodiment, the inner coil extends distally beyond the distal end of the outer coil, providing increased flexibility in a distal portion of the shaft. An inflation balloon is attached to the distal end of the shaft. The shaft includes an inflation lumen formed through the inner coil and a wire guide lumen formed through the distal portion of the shaft and extending through the chamber of the balloon.

Abstract: A catheter enabling an increase in operability when the catheter is inserted from the outside to the inside of a body and capable of remarkably reducing the risk of damage to shafts even in an unforeseen accident without complicating steps and increasing production cost. The catheter comprises at least the distal side shaft formed of a resin tube, the rear end side shaft with a higher rigidity than that of the distal side shaft, and a guide wire lumen. The catheter is characterized in that a core wire is disposed therein to adjust a flexibility so that the rear end portion of the distal side shaft is harder than the distal end portion of the distal side shaft and softer than the rear end side shaft, and the core wire is fixed to the distal side shaft near the rear end side opening part of the guide wire lumen and at a part of the rear end side portion of the distal end shaft.

Abstract: An elongate shaft of a medical catheter including a thermoset polymeric tubular member including a skived distal portion. The skived distal portion includes a distally extending trough having a convex surface and a concave surface. A thermoplastic tubular sleeve may be positioned over at least a portion of the skived distal portion of the thermoset polymeric tubular member. In some instances, the thermoplastic tubular sleeve includes a crescent-shaped tubular portion defining a crescent-shaped lumen. The trough of the skived distal portion may extend through the crescent-shaped lumen. The thermoplastic tubular sleeve is thermally bonded to the inner and outer tubular members of a distal section of the elongate shaft at a guidewire port joint.

Abstract: An infusion catheter and method, with an elongated shaft having a guidewire lumen which has a proximal section and a common distal section extending to a distal port at a distal end of the shaft, and an infusion lumen which is in fluid communication with the distal port of the guidewire lumen and which joins the common distal section of the guidewire lumen at a location distal to the guidewire proximal port. A restricted passage from the infusion lumen to the common distal section of the guidewire lumen has a smaller transverse dimension than the guidewire lumen and a guidewire slidably disposed in the guidewire lumen.

Abstract: A balloon catheter including an elongated shaft having an inflation lumen, a guidewire lumen, a proximal shaft section, and a distal shaft section with a balloon on the distal shaft section, the distal shaft section formed by an outer tubular member having an opening in a sidewall, and an inner tubular member having a distal portion in the outer tubular member and a proximal portion extending through the sidewall opening and along an outer surface of a portion of the outer tubular member located proximal to the sidewall opening, with polymeric filler material around the outer surface of at least the proximal portion of the inner tubular member. The inner tubular member preferably comprises a polymeric tube having a reinforcing coiled member embedded therein. Preferably, a crescent shaped portion of the inflation lumen extends along side the proximal portion of the inner tubular member.

Abstract: A method and apparatus for introducing a first elongate medical device and short wire guide that are coupled together into a work site and remotely disconnecting them within the work site such that a secondary device comprising a catheter member can be introduced over the wire guide to the work site, and/or a second wire guide can be introduced to the work site via a passageway of the primary access device. A separating member may be provided to remotely separate the wire guide from the elongate medical device. In one example of the method, a wire guide and primary access device (e.g., a sphincterotome) is coupled to the wire guide and introduced via a duodenoscope into the biliary system.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof. The device includes a wholly external wire guide structure secured to the tubular shaft by a figure-eight polymer sleeve.

Abstract: An insert for joining sheaths for use in a medical device is described. The insert has a first end including a first operative coupling and a second end including a second operative coupling. The first operative coupling is for engaging a first tube at its distal end, and the second operative coupling is for engaging a second tube at its proximal end. The insert also includes a first passageway extending through the insert from the second end to an exit port disposed between the first operative coupling and the second operative coupling. This disclosure also provides a catheter including such an insert, and a method of assembling a catheter.

Abstract: One aspect of the invention is directed to a balloon catheter with a multilayered polymeric sleeve at the rapid exchange intermediate section, having an outer layer formed of a polymer with a relatively low processing temperature (i.e., melting temperature for semi-crystalline polymers or glass transition temperature for amorphous polymers), and having an inner layer.

Abstract: A detachable introducer and method of using such introducer is disclosed for inserting an embolic coil deployment system into the tortuous vasculature of the human brain for placing an embolic coil within an aneurysm. The introducer includes a sheath having a lumen, a side opening and a longitudinal slit. A deployment catheter with a conical expander member is slideably disposed through the side opening of the sheath and through the lumen of the sheath. The conical expander member detaches the introducer from the deployment catheter through the longitudinal slit of the sheath.

Abstract: Methods of and devices for palliating gastrointestinal strictures using rapid exchange type enteral stent placement catheters. The catheter may include an inner member and an outer member, with the two members being slidable with respect to one another. In various device embodiments, a ramp for directing a guidewire out from within the catheter is provided using portions of the outer member or a shaped mandrel. The inner member may take a number of forms, including a tubular distal portion, a skived or integrally attached elongate midsection, and a proximal portion. A mandrel can be used in a portion proximal of the guidewire ramp, with the mandrel taking one of several disclosed forms.

Abstract: A rapid-exchange balloon catheter or stent delivery system, for medically treating a patient, has a proximal hub, a balloon, and an improved shaft design. The catheter shaft has a tubular outer body that includes a hypotube extending from the catheter proximal end to a position at or near the proximal leg of the balloon. An inner tubular body defines a guidewire lumen and extends from a distal guidewire port at the catheter distal end to proximal guidewire port located between the balloon and the proximal hub. The hypotube has an aperture for accepting the inner body proximal end and a circumferential cut pattern. The cut pattern adds flexibility and may have any desired shape, including a spiral, a helical undulating path, or an overlapping serpentine path with inflection points, for example. The proximal guidewire port may be positioned on or in between the individual portions of the cut pattern.

Abstract: A catheter assembly and method includes a multi-lumen portion having a guide wire lumen and an inflation/deployment lumen. The guide wire lumen includes a distal guide wire lumen portion having a rapid exchange guide wire port, and a proximal guide wire lumen portion rotatable to selectively expose the rapid exchange guide wire port. The inflation/deployment lumen includes a rotatable seal which facilitates rotation of the proximal guide wire lumen portion.

Abstract: A single operator exchange biliary catheter having a tubular member extending proximally from the proximal guidewire port. The tubular member defines a guidewire lumen extension adapted to permit the guidewire to be retracted from guidewire lumen and re-inserted therein. By retracting the guidewire from the guidewire lumen and into the guidewire lumen extension, fluid may be readily injected via the guidewire lumen without encountering resistance to fluid flow from the guidewire. The guidewire lumen extension also maintains guidewire lumen access such that the guidewire may be easily re-inserted into the guidewire lumen.

Abstract: A perfusion guidewire is disclosed. The perfusion guidewire includes an elongate core member and a collapsible sheath tightly wrapped around at least the distal portion of the elongate core member such that the wrapped sheath is folded upon itself, forming a plurality of layers of material in a radial direction from the longitudinal axis of the elongate core member. The wrapped sheath is tightly wrapped about the elongate core member such that the wrapped sheath and elongate core member travel as a unit during navigation within the blood vessel of the body of a patient. The wrapped sheath is expandable to a larger diameter in order to allow a perfusate to pass through the lumen of the sheath.

Abstract: A catheter includes a distal shaft, and a proximal shaft having its distal portion inserted and fixed in the distal shaft. The distal shaft includes a guide wire lumen, and a distal shaft lumen, with the distal shaft lumen communicating with a proximal shaft lumen. The proximal shaft includes a main body portion, a distal portion smaller in size than the main body portion and entering into the distal shaft lumen, and a proximal shaft inclined portion located between the main body portion and the distal portion. The distal shaft lumen has a lumen change portion reduced in lumen cross-section toward the distal side. The proximal shaft inclined portion and the lumen change portion abut on each other.

Abstract: A nasogastric tube insertion system comprises a nasogastric tube, a guide element, and an inserter element. The inserter element has a slim, elongate main body, a handle attached to the body, and an anatomically curved insertion section. The guide element comprises a swallowable weight attached to a cord, string, monofilament line, or other similar line. The nasogastric tube may be a nasogastric feeding tube and comprises a tube having one or more interior bores or lumina and a guide element capture structure. In use, the swallowable weight is placed onto the end of the inserter element. The inserter element is inserted through the patient's nasal passages and optionally into the oropharynx. The weight is released and the patient swallows it into the stomach. The guide element is threaded through the guide element retaining structure, and the nasogastric tube is safely inserted along the guide element into the patient's stomach. The tube and guide element are removed together when no longer needed.

Abstract: A device in the form of a conversion adapter for reducing an internal lumen of a catheter so as to accommodate a guidewire having a diameter substantially smaller than the internal lumen of the catheter as well as a catheter system including such a conversion adapter is provided. The adapter is positionable within the internal lumen of the catheter. The adapter has an external diameter which is substantially equal to the internal lumen of the catheter and further includes a smaller internal lumen which is substantially equal in diameter to the guidewire and is therefore capable of accommodating the smaller diameter guidewire therethrough. Preferably, the adapter extends within the internal lumen of the catheter along the entire length thereof, and preferably extends beyond the length of the catheter, including a flexible tapered tip at the end portion.

Abstract: A catheter device including an elongate tubular shaft having a consistent material composition for a substantial proportion of its length. The device includes a proximal shaft portion having a first flexibility and a distal shaft portion having a second flexibility, wherein the second flexibility is greater than the first flexibility and wherein at least the distal shaft portion comprises at least one score in a surface thereof.

Abstract: A nasogastric tube insertion system comprises a nasogastric tube, a guide element, and an inserter element. The inserter element has a slim, elongate main body, a handle attached to the body, and an anatomically curved insertion section. The guide element comprises a swallowable weight attached to a cord, string, monofilament line, tube, or other similar line. The swallowable weight may be ablative in the presence of stomach fluids or may be deflated to allow the guide element to be removed while the nasogastric tube remains in place. The inserter element is inserted through the patient's nasal passages and optionally into the oropharynx. The weight is released and the patient swallows it into the stomach. The guide element is threaded through the guide element retaining structure, and the nasogastric tube is safely inserted along the guide element into the patient's stomach.

Abstract: Rapid exchange angioplasty catheters and methods of constructing rapid exchange angioplasty catheters including features that provide good pushability and kink resistance. In an illustrative embodiment, a catheter is provided, the illustrative catheter including a proximal hypotube section, which connects to a more distal braided catheter section. The braided catheter section connects to a midshaft portion that includes a guidewire entry port. Distal of the midshaft portion is a distal section having a balloon disposed thereon. An inflation lumen extends the length of the catheter, while a guidewire lumen extends only from the guidewire entry port to the distal end of the catheter. Optionally, a core wire may extend across the joint from the hypotube, to the braided catheter section, and past the guidewire entry port.

Abstract: A nasogastric tube insertion system comprises a nasogastric tube, a guide element, and an inserter element. The inserter element has a slim, elongate main body, a handle attached to the body, and an anatomically curved insertion section. The guide element comprises a swallowable weight attached to a cord, string, monofilament line, or other similar line. The nasogastric tube comprises a tube having one or more interior bores or lumina and a guide element capture structure. In use, the swallowable weight is placed onto the end of the inserter element. The inserter element is inserted through the patient's nasal passages and optionally into the oropharynx. The weight is released and the patient swallows it into the stomach. The guide element is threaded through the guide element retaining structure, and the nasogastric tube is safely inserted along the guide element into the patient's stomach. The tube and guide element are removed together when no longer needed.

Abstract: One aspect of the invention is directed to a balloon catheter with a multilayered polymeric sleeve at the rapid exchange intermediate section, having an outer layer formed of a polymer with a relatively low processing temperature (i.e., melting temperature for semi-crystalline polymers or glass transition temperature for amorphous polymers), and having an inner layer.

Abstract: A suture construction and method for forming a suture construction is disclosed. The construction utilizes a suture having an enlarged central body portion defining a longitudinal passage. First and second ends of the suture are passed through first and second apertures associated with the longitudinal passage to form a pair of loops. Portions of the suture lay parallel to each other within the suture. Application of tension onto the suture construction causes constriction of the longitudinal passage, thus preventing relative motions of the captured portions of the suture.

Abstract: A rapid exchange catheter device comprising: an elongated collapsible catheter body with a distal end and a proximal end, having a duct along a portion of the distal end of the elongated body for engagement with a guide-wire, and having a lumen extending from the proximal end towards the distal end, a portion of the lumen at the distal end substantially parallel to at least a portion of the duct; and a stiffening insert for inserting inside the lumen up to a distal end of the lumen, so as to allow advancing the catheter by advancing the stiffening insert, which pushes the distal end of the elongated body at the distal end of the lumen, dragging the rest of the catheter behind it.

Abstract: The invention includes a catheter having an elongate main body having a proximal section and a distal section. The elongate main body further includes a first guidewire lumen and a second guidewire lumen. Each guide wire lumen including a proximal port and a distal port in communication with an external environment. The proximal port of the first guidewire lumen spaced by a gap from the distal port of the second guidewire lumen. In accordance with a further aspect of the invention, the catheter includes a plurality of overlapping stiffening members defined along at least a portion of a length between the distal end and the proximal end of the elongate main body.

Abstract: A rapid exchange balloon dilation catheter includes a catheter shaft with a proximal tubular member defining a proximal inflation/deflation lumen for conveying fluids therethrough with a distal portion of the bore of proximal tubular member filled with a fluid-impervious barrier, a distal body extending from the fluid-impervious barrier to the distal end of the shaft, a plurality of distal tubular members defining distal inflation/deflation lumens in fluid communication with the proximal inflation/deflation lumen and extending through the fluid-impervious barrier and the distal body to the distal end of the shaft distal portion, a guidewire tubular member having a bore extending from a side aperture formed in the distal body through the distal body alongside the distal tubular members in a multi-lumen arrangement, and a plurality of stiffening members extending from within the fluid-impervious barrier into the distal body to a point within the shaft distal portion.

Abstract: The present invention is primarily directed to a rapid exchange catheter that permits axial movement of an inner conduit within an outer conduit comprising: • an outer conduit; • an inner conduit, suitable for total or partial passage over a guide wire, wherein said inner conduit is movably disposed within the lumen of said outer conduit, wherein the proximal end of said inner conduit is angled such that it pierces the wall of said outer conduit; • means for permitting axial movement of said inner conduit within said outer conduit, such that said movement is not hindered by the passage of the angled proximal part of the inner conduit through said outer conduit; and • means, situated at the proximal end of the outer conduit, for causing axial pushing-pulling movements of said inner conduit.

Abstract: Novel systems enable PTNA rapid exchange (RX) types of systems for ICAD, support balloon test occlusion, treatment of vasospasm after sub-arachnoid hemorrhage (SAH) and facilitate aneurysm neck remodeling during coiling embolization. The systems disclosed include an embodiment having a catheter comprising a RX port for providing catheter support within and above the carotid siphon and distal vertebral arteries, a conformable, semi-compliant balloon manipulable to gain forward progress through intracranial vessels substantially narrowed by plaque in combination with at least a guidewire, and a tip disposed at a distal end of the catheter.

Abstract: An inner catheter (36) for use in an endoluminal delivery assembly (10) includes a stiffening element positioned at a transition between a hypotube (36a), a middle tube (36b) and a distal tube (36c) of the inner catheter (36) having different flexibilities. The stiffening element comprises three stiffening wires (42) embedded within the internal wall of the inner catheter (36) at their proximal ends. The stiffening wires (42) extend inwardly and distally to meet at an apex (60).

Abstract: A rapid exchange balloon catheter having a proximal end and a distal end, said catheter comprising: a tubular metal shaft body extending from the proximal end along a majority of the total length and having an inflation lumen arranged therein, a plastics distal end portion bonded to the metal body in extension thereof, said distal end portion being provided with an inflation lumen in communication with a balloon, and a guide wire lumen, said guide wire lumen extending from a proximal side port to a distal end opening. To reduce the resistance to kinking, the metal body comprises a transitional region having reduced stiffness at the position of bonding to the plastics distal end portion compared to a more proximal position along the metal body.

Abstract: A rapid exchange catheter comprises a guide wire lumen including a substantially sealed portion in which a lumen wall extends around an entire periphery thereof and a channel portion including a channel opening the lumen to an exterior of the catheter, wherein a width of the channel is less than a maximum width of the channel portion. A guide wire ramp extends into the channel portion, with the ramp extending further into the lumen of the channel portion as a distal end of the ramp is approached.

Abstract: The invention includes a catheter having an elongate main body portion and a distal body portion. The elongate main body portion has a proximal end and a distal end. The main body portion further includes a coil having at least one complete turn about a central axis, the coil defining a passage along the central axis. The elongate distal body portion extends from the distal end of the main body portion. In accordance with a further aspect of the invention, the distal body portion has a proximal end and a distal end and can include a guidewire lumen defined along at least a portion of a length between the distal end and the proximal end of the distal body portion. The guidewire lumen has a distal guidewire port and a proximal guidewire port defined in communication therewith. The passage can be in fluid communication with an exterior of the catheter.

Abstract: A rapid exchange stent delivery catheter includes an inner tubular member having a proximal portion, a distal portion, a stent holding portion located adjacent the distal portion of the inner member, and a guide wire lumen extending from a proximal guide wire opening disposed distal of the proximal portion of the inner member to a distal guide wire opening disposed at a distal end of the inner member. The proximal guide wire opening has a first length. An outer tubular member is slidably disposed about the inner member. The outer member has a proximal portion, a distal portion, and a guide wire opening disposed distal of the proximal portion of the outer member. The guide wire opening of the outer member has a second length that is shorter than the first length and a guide wire ramp extends into, and is movable along the first length.

Abstract: A catheter comprising an inflatable balloon having a proximal end, a distal end, and an inflation cavity therebetween, a catheter shaft having the inflatable balloon affixed proximate a distal end thereof, the catheter shaft having an inflation lumen fluidly connected to the balloon inflation cavity. A guidewire lumen extends through the balloon cavity within a tubular member which is affixed to the inflatable balloon proximate the distal end. A reinforcing sleeve, having a proximal portion and a distal portion with a lumen extending therethrough, wherein the distal portion of the sleeve extends into the inflation cavity with at least a portion of the tubular member slidably disposed through the lumen thereof and the proximal portion is fixed relative to the catheter shaft and disposed in the catheter shaft inflation lumen.

Abstract: A stiffenable balloon catheter assembly capable of being converted from an “over-the-wire” mode with respect to a guidewire extending therethrough to a “rapid-exchange” mode with respect to a guidewire extending therethrough, and vice versa. The catheter has a plurality of lumens, one lumen however, having a side opening with an obstructable galp, the orientation of which, determines the utilization “mode” of the catheter assembly. Stiffening stylets may be adjustably locked into the lumens, depending upon the “mode”, to control the stiffness of the catheter assembly during its utilization within a patient.