US20090018502A1 - Adjustably Stiffenable Convertible Catheter Assembly - Google Patents

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.

Description

CROSS-REFERENCE TO RELATED APPLICATION
• This is a continuation of application Ser. No. 07/681,805, filed Apr. 5, 1991.
BACKGROUND OF THE INVENTION
• 1. Field of the Invention
• This invention relates to a catheter having a balloon at its distalmost end, and having means for adjustably controlling the stiffness of the catheter shaft, and more particularly to a convertible-type balloon catheter having stiffener means disposed within the catheter.
• 2. Prior Art
• Balloon catheters are utilized for insertion into the human body into lumens therewithin. The catheters are of necessity made of a flexible plastic extrusion such as polyethelene, polyester or polyamide. Advancement and manipulation of a catheter requires a certain stiffness or pushability of the catheter itself, by the physician, without injuring the patient in which the catheter is placed.
• A number of approaches have been made, in attempting to provide stiffness to catheters. U.S. Pat. No. 4,964,853 to Sugiyama et al shows a balloon catheter having a braided wire member disposed within the catheter body itself in a meshlike manner. Mesh is imbedded in the wall of the inner tube. U.S. Pat. No. 4,875,841 to Higgins shows a balloon catheter having a coiled wire arranged within the proximalmost hub, which coiled wire extends in an uncoiled manner within the body of the catheter shaft itself. The coil and the wire itself being co-rotatable so as to provide rotational stiffness to the catheter.
• U.S. Pat. No. 4,822,345 to Danforth shows a variable stiffener balloon catheter, for percutaneous transluminal coronary angioplasty procedures. This patent to Danforth shows a method of providing for variable flexibility, by the use of a longitudinally extended balloon arranged along the exterior of the catheter shaft. Pressurization or depressurization of this balloon is effectuated by a syringe, which pressurizably controls the rigidity of the balloon itself. A further embodiment of this concept of Danforth utilizes relatively stiff wires running through channels in the periphery of the catheter, the wires adding the stiffness to the catheter.
• The preformed catheter assembly shown in U.S. Pat. No. 4,738,667 to Galloway discloses a sheath which is slideably mounted over the catheter so as to be moved from the proximal to the distal end, to straighten out the distal end during insertion and removal of the catheter from a body. The catheter assembly shown in U.S. Pat. No. 4,737,152 to Alchas shows a stylet or stiffening wire arranged within a lumen connected to the closed distal end of the catheter and also there is a loop on its proximalmost end. The loop is arranged in a rotatable knob to facilitate rotation of the distal end of the catheter while providing stiffness, while the proximal end is turned.
• U.S. Pat. No. 4,586,923 issued to Gould et al shows a curving tip catheter having a catheter body which includes a sheath of braided wire having a meshlike configuration positioned around the wall of the tubular body to provide tortional stiffness to the body relative to the flexible tip. In an alternative embodiment, a relatively stiff but bendable inner plastic tubing can be inserted within the tubular body to provide tortional stiffness to that body. In a somewhat similar vein, U.S. Pat. No. 4,516,972 to Sampson shows a guiding catheter having a helically wound ribbon of flexible material embedded within the wall of the catheter, so as to provide tortional rigidity and stiffness.
• In yet a further embellishment on the idea of stiffening a balloon catheter, U.S. Pat. No. 4,448,195 to LeVeen et al shows a reinforced balloon catheter which has a guidewire adapted to be inserted for stretching the catheter when it is inserted into a blood vessel to stiffen the catheter and position it. In an alternative arrangement, a braided shell wire reinforcement is used within the braids, which are placed at the beginning and endings of the thinned portion of the catheter. U.S. Pat. No. 4,033,331 to Guss et al, discloses a contour or stiffening wire slideably disposed within a lumen extending substantially the full length of the catheter. Slight retraction of the stiffening wire from the distal end of the lumen permits catheter to assume a predetermined curvature thereat.
• It is thus an object of the present invention to provide a catheter having variable stiffness capabilities therewithin. The catheter of the present invention should overcome the problems of the prior art by getting the physician to properly adjust the rigidity or stiffness of the catheter shaft according to the particular situation that warrants it in conjunction with the capability of utilizing the catheter shaft in a convertible manner between a “rapid-exchange” mode and an “over-the-wire” mode.
BRIEF SUMMARY OF THE INVENTION
• The present invention comprises a balloon catheter having a catheter shaft with at least three lumens extending from the proximal to the distal ends thereof. The first and second lumens may preferably but not necessarily be of cresent shape in cross-section, and the third lumen is of circular cross-section. At, least one of the cresent shaped lumens has a stiffening mandrel extending therethrough. In a preferred embodiment, the third lumen has a side opening arranged relatively close yet proximal to the balloon at the distal end of the catheter assembly.
• The balloon on the distal end of the catheter shaft is in fluid communication with one of the cresent shaped lumens. The first shaped lumen has a closed distalmost end, at the proximal end of the balloon.
• The third lumen, preferably of circular cross-section, extends from the proximal end of the catheter shaft, and through the balloon, open at its distalmost end at the distal end of the balloon. The third lumen is adapted to receive a guidewire, either through the entire length thereof, or from an opening proximal of the balloon and through to its distalmost end.
• In a preferred embodiment, a guidewire is adaptable to enter the third “distal” lumen at its opening at the distalmost end of the catheter and extend through that lumen, through the balloon, and exit out the side opening through the sidewall of the catheter, proximal of the balloon. The side “guidewire” opening of the third lumen being disposed through the wall of the catheter shaft at a location which is also proximal to the distal end of the stiffening mandrel in the first cresent shaped lumen. This rapid exchange mode with a guidewire extending partway through may occur with a stiffening stylet disposed within the third lumen, the stylet extending up to a location adjacent the side opening, from the proximal end of the catheter. This same lumen, a portion of which is utilized for the “rapid-exchange” mode, is utilized in its entire length, for the catheter in its “over-the‘wire” mode, where a guidewire enters the distal opening of the third “distal” lumen, and exits at the proximal end of the catheter at the proximal end of that third lumen, through a connector or adaptor.
• The present invention thus comprises a multiple lumen catheter (at least three lumens) having proximal and distal ends, the proximal end having a Y-connector thereat for adaptation of inflation devices or control functions, the distal end comprising an inflatable elongated balloon.
• A first of the lumens has an elongated stiffening mandrel disposed therein, the lumen being closed at its distalmost end. The stiffening mandrel being preferably made of Nitinol. A second of the lumens extending from the connector, and into the balloon, providing fluid communication therewith. The third of the lumens being preferably circular in cross-section, extending from the connector and through the balloon, and open through the distal tip of the catheter shaft. A “side” orifice being disposed through the wall of the catheter and into the third lumen, just proximal (about 15 to 35 cm) of the balloon. The stiffening mandrel in the first lumen extending distally of the side orifice in the third lumen to the proximal end of the catheter, so as to allow a smoother transition of catheter stiffness when the assembly is utilized in a rapid exchange mode—that is, when a guidewire extends only part way through the third lumen, out through the “side” orifice after entering that lumen distally and to help transmit “push” on the catheter shaft from its proximal end. The same lumen therefore, in the same catheter, functioning as a lumen for an “over-the-wire” mode, as well as a “rapid-exchange-wire” mode, using part of the lumen for a guidewire and part of that lumen for catheter stiffening assistance.
BRIEF DESCRIPTION OF THE DRAWINGS
• The objects and advantages of the present invention will become more apparent when viewed in conjunction with the following drawings, in which:
• FIG. 1 is a sectional side-elevational view of the distal portion of a catheter assembly constructed according to the principles of the present invention;
• FIG. 1ais an enlarged view of the “side opening” shown in cross-section inFIG. 1;
• FIG. 2 is a cross-sectional view taken along the lines II-II ofFIG. 1;
• FIGS. 3a,3b, and3care side-elevational views of stiffening mandrels contemplated with this catheter assembly;
• FIG. 4 is a side-elevational view of a catheter assembly showing a bifucated connector therewith;
• FIG. 5 is a side-elevational view of the proximal end of the catheter assembly showing a trifurcated connector therewith;
• FIG. 6 is a side-elevational view of the catheter assembly in an “over-the-wire” mode;
• FIG. 7 is a side-elevational view of the catheter assembly in a “rapid exchange mode” configuration; and
• FIG. 8 is a side-elevational view of the catheter assembly in a further embodiment thereof.
• FIG. 9 is a side view of a part of a catheter shaft, in a further embodiment of the side opening;
• FIG. 10 is a plan view of the opening shown inFIG. 9;
• FIG. 11 is a side view of part of a catheter shaft in yet a further embodiment or the side opening, and;
• FIG. 12 is a plan view of the opening shown inFIG. 11.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
• Referring to the drawings now in detail, and particularly toFIG. 1, there is shown the distal portion of acatheter assembly10, also shown in its extendedmost form inFIG. 4. Thecatheter assembly10 comprises an extrudedcatheter shaft12 having a plurality of lumens disposed axially therethrough. Thecatheter shaft12 has afirst lumen14, and asecond lumen16, both of which are preferably, but not necessarily of cresent shape, as shown in the cross-sectional view ofFIG. 2. Thecatheter shaft12 also includes athird lumen18, which is preferably of circular cross-section.
• Thecatheter shaft12 has an elongatedballoon20 disposed about its distalmost end, in a known manner. Thefirst lumen14 extends from an opening, not shown, in a connector22, shown inFIG. 4, distally towards aclosed end24, at the proximal end of theballoon20. A stiffeningmandrel26, as shown inFIG. 1, is disposed within the length of thefirst lumen14. The stiffeningmandrel26 may have a ball weldedtip28 or be otherwise tapered and flexible on its distalmost end, to prevent puncture of thelumen14 by themandrel26.
• Thesecond lumen16 extends from the connector22, through theshaft12, parallel to thefirst lumen14, except that thesecond lumen16 is in fluid communication with theballoon20, as shown inphantom lines17, inFIG. 1. Thesecond lumen16 provides a conduit for pressurized fluid for inflating and deflating theballoon20 from an inflation/deflation device, not shown, which would be adaptable to the connector22. It is to be noted that the view ofFIG. 1 is sectioned to show thefirst lumen14 and thethird lumen18, and not longitudinally bisect the web ofmaterial19 separating the first andsecond lumens14 and16.
• Thethird lumen18, of generally circular cross-section, extends from the connector22, through theshaft12, and through theballoon20, opening distally of theballoon20, as shown inFIGS. 1 and 1A. Thethird lumen18 is not in fluid communication with theballoon20.
• An opening orside orifice30 is disposed through the wall of thecatheter shaft12, and into thethird lumen18, as shown inFIG. 1. Theside opening30 in this preferred embodiment is preferably a slightly oval opening of about 3 mm long and 0.5 mm wide, arranged at a sharp angle “A” of about 20 to about 60 decrees with respect to the longitudinal axis of the shaft. Theside opening30 includes a valve-like cover flap32, integral with theshaft12 with adistally tapering edge33, theflap32 being about the size to cover theopening30, and is resilient so as to allow it flex over theopening30, and within thethird lumen18, obstructing it somewhat, depending upon how theflap32 is being biased. Theside opening30 is disposed a distance “x” of about is to about 35 cm. from the proximal end of theinflated balloon20, as shown inFIGS. 1 and 4. The third or “distal”lumen18 may thus be utilized in its entire length, from the proximal connector22 to its distalmost orifice, for receiving a guidewire in an “over-the-wire” mode, theflap32 roughly covering the inside of theopening30. Thelumen18 may also be utilized, from theopening30 to its distal end, in a “rapid-exchange-wire” mode with a guidewire extending through the distal end of thethird lumen18 and out the opening39 once theflap32 is flexed out of the way.
• An RO (radio opaque)marker band34 is disposed about thecatheter shaft12, (essentially the structure comprising the third lumen18), at the mid-point of theballoon20 in either the “over-the-wire” mode or the “rapid-exchange” mode.
• In one embodiment of the present invention, where thecatheter assembly10 is utilized as aforementioned in the traditional “over-the-wire” catheter, aguidewire50, normally initially having been inserted into a patient's vessel, and having its proximal end outside of the patient, has that proximal end inserted through the distal end of thecatheter assembly10, through the “distal” orthird lumen18, and it extends proximally, out of theproximal guidewire connector42, as shown inFIG. 6. Theflap32 performs basically like a valve, by shutting itself against theopening30, thus permitting an unobstructed lumen for passage of the guidewire40, or for passage of pressurized fluid injected proximally in thelumen18 to pass through thelumen18, to escape primarily out of the distal end of thecatheter shaft12 through thelumen18.
• In a further embodiment of the present invention, where thecatheter assembly10 may be utilized in the aforementioned “rapid-exchange” mode, theguidewire50, normally initially inserted into a patient's vessel, and having its proximal end outside of the patient, has that proximal end inserted through the distal end of thecatheter assembly10, through the “distal”lumen18, and extending outwardly proximally, through theside opening30 as shown inFIGS. 1 and 7. Theguidewire50 in this mode, extends parallel to and external of theshaft12, proximal of theside opening30. The enlarged view inFIG. 1A depicts theguidewire50 shown in phantom lines, and theflap32 in close fitting overlapping relationship to theguidewire50. During the threading of the guidewire through thedistal lumen18, it is anticipated that theshaft12 would be bent into a “U” shape at theopening30, with theopening30 in the trough of the “U”, so as to cause theflap32 to bend “away” from theopening30, obstructing thelumen18 proximally therepast to permit theguidewire50 to be threaded through thelumen18 and out theopening30.
• Additionally, when thecatheter assembly10 is utilized in this “rapid-exchange” mode, a stiffeningstylet52 may be inserted within the “distal” orthird lumen18 through the connector22, as shown inFIGS. 1,1A and2. The stiffeningstylet52 has adistal end54 which would extend only up to theside opening30, and no further. The stiffeningstylet52 may have several different configurations, such as shown inFIG. 3A,3B or3C. Thestylet52 shown inFIG. 3A, is astraight mandrel54, having uniform diameter along its entire length. Thestylet52 shown inFIG. 3B, is a tapered mandrel56, having an initial diameter (its non-tapered end) of about 0.20 inches, and tapering about 5 cm. or more along itsdistal length57 to a diameter of about 0.008 inches. Thestylet52 shown inFIG. 3C is a taperedmandrel58, similar to the mandrel56 shown inFIG. 3B, but having aball weld60 therein, of a diameter of about 0.020 inches. Eachstylet52 may be made from a stainless steel or Nitinol material, in a known manner.
• It is critical to the present invention that the location of the distalmost end of the stiffeningmandrel26 emplaced within thefirst lumen14, as shown inFIG. 1 be juxtaposed distal to the location of theside hole30 in thedistal lumen18 of theshaft12.FIG. 5 shows a trifurcatedconnector59 mounted on the proximal end of acatheter shaft12 having a lockinghub61 which would be arranged to adjustably lock at stiffeningstylet26 within thefirst lumen14 if desired. Afurther locking hub63 may be arranged off of theconnector59 to adjustably seize a stiffeningmandrel52 in thethird lumen18 for longitudinal adjustment thereof, at the physicians option, while the catheter is being utilized in the “rapid-exchange” mode.
• FIG. 8 shows a further adaptation of thecatheter assembly10, wherein a plurality oforificii66 is disposed through the wall of thecatheter sheath12 to provide fluid communication with thedistal lumen18 from the outside of thecatheter shaft12 at a location proximal of theballoon20, and distal of theside hole30. Theorificii66 are about 0.025 inches in diameter, and function as openings for passive perfusion. A further similar plurality oforificii68 is disposed through the wall of thesheath12 and distal of theballoon20, to provide fluid communication with thedistal lumen18, to function as openings for passive perfusion with respect to thatlumen18.
• A further embodiment of theside hole30 is shown inFIG. 9, wherein a portion of acatheter shaft74 has a “distal”lumen76 extending therethrough, in a manner similar to theaforementioned catheter shaft12. Aslit78 is cut diagonally through the outer wall of thecatheter shaft74, making aflap80, which when flexibly lifted away from thelumen76 provides a “D” shaped opening, through which aguidewire82 may be passed.FIG. 10 shows theflap80 in its “at rest” configuration, with the “D” shaped opening closed, to provide afull passage lumen76 thereadjacent.
• A yet another embodiment of theside hole30 is shown inFIG. 11, wherein a portion of acatheter shaft84 has a “distal”lumen86 extending therethrough. Aslot88 about 2 cm. long and 0.05 cm wide is disposed longitudinally through the outer wall of thecatheter shaft84, to make a flexibly openable orifice which aguidewire90 may be passed.FIG. 12 shows the slot38 in a plan view, in its “at rest” configuration.
• Thus what has been shown is a novel stiffenedcatheter assembly10 capable of being utilized by a physician as an “over-the-wire” catheter with adjustable stiffness means therewith, or optionally as a “rapid-exchange-wire” catheter apparatus, also including the capability of being able to control or vary the stiffness of the catheter shaft by selective insertion and/or controlled withdrawal of a stiffening stylet adaptably arranged within the guidewire lumen, the “rapid-exchange-wire” mode being facilitated by a side opening having valve-like obstructable flap across its inner side to minimize fluid exchange when that lumen accepts the catheter to be utilized in its full length “over-the-wire” mode. In its use as either a “rapid-exchange-wire” or an “over-the-wire” mode, the portion of the “distal” lumen enclosing the guidewire may have a plurality of orificii through the wall of the catheter shaft just proximal and just distal of the elongated inflated balloon, to permit perfusion of body fluid across the then expanded balloon in the body vessel.

Claims (15)

1-28. (canceled)

29. A rapid-exchange balloon catheter, comprising:

an elongated polymer catheter body and an inflatable balloon, inflatable by delivering an inflation fluid through the body, said catheter operable in rapid-exchange mode by locating a guidewire through a side wall of said catheter body and into a first lumen of said catheter body, said catheter body having a separate second lumen including an elongated stiffener.

30. The balloon catheter ofclaim 29, wherein the elongated stiffener is tapered.

31. The balloon catheter ofclaim 29, wherein the elongated stiffener has a proximal end and a distal end and comprises a ball-welded tip at the distal end.

32. The balloon catheter ofclaim 29, wherein the catheter body further includes a third lumen.

33. The balloon catheter ofclaim 29, further comprising a guidewire within the first lumen.

34. The balloon catheter ofclaim 29, wherein the side wall of the catheter body defines an opening.

35. The balloon catheter ofclaim 34, wherein a guidewire is capable of entering the catheter body through the opening.

36. The balloon catheter ofclaim 34, wherein a guidewire extends from the opening through the first lumen and the balloon.

37. The balloon catheter ofclaim 34, wherein the opening comprises a slit.

38. The balloon catheter ofclaim 34, wherein the opening comprises a slot.

39. The balloon catheter ofclaim 34, wherein the balloon has a proximal end and a distal end, and the opening is located about 15 centimeters to about 35 centimeters proximal to the proximal end of the balloon.

40. The balloon catheter ofclaim 39, wherein the elongated stiffener comprises a mandrel.

41. The balloon catheter ofclaim 39, wherein the elongated stiffener comprises Nitinol.

42. The balloon catheter ofclaim 39, wherein the catheter body comprises a polyethylene, a polyester, or a polyamide.

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