Single Operator Exchange Perfusion Catheter Having a Distal Catheter Shaft Section

The present invention relates generally to methods and devices used in intravascular therapeutic and diagnostic procedures, and more particularly, to a method and apparatus for performing a balloon angioplasty procedure.

Intravascular catheterization devices have proven to be useful and efficient for both therapeutic and diagnostic purposes. Intravascular therapeutic techniques, such as angioplasty, atherectomy, and laser irradiation, have been developed as alternatives to bypass surgery for treating vascular diseases or other conditions that occlude or reduce the lumen size of portions of a patient's vascular system. In particular, balloon angioplasty has proven to be a useful and in many circumstances a preferred treatment for obstructive coronary diseases. Also, intravascular diagnostic techniques, such as ultrasonic imaging and Doppler blood flow measurements, have been developed to measure or image the extent of an occlusion of a vessel (e.g., stenosis). The devices used to perform the aforementioned intravascular therapeutic and diagnostic techniques may be used together or in conjunction with more invasive techniques such as coronary surgery.

These intravascular therapeutic and diagnostic devices have achieved acceptance because of their effectiveness as well as the fact that they can be used in a minor surgical procedure that is relatively nondisruptive to the patient compared to coronary surgery. These devices rely on the positioning of a catheter into the vascular system of a patient via an incision at an accessible location which may be remote from the site of the occlusion or stenosis. For example, the accessible location may be the femoral artery at the groin. The intravascular device is then advanced through the incision via the femoral artery to a desired distal site. The distal sites into which the device may be advanced include the coronary arteries, branch vessels stemming from the external carotid artery such as the occipital and the arteries leading to the vessels of the head and brain, splenic, and the inferior mesenteric and renal arteries leading to the organs of the thorax as well as other vessels.

Because of the small size of some of these vessels and the tortuous passages through the vessels, positioning of a catheter device through a patient's vasculature can be a difficult and time consuming task requiring considerable skill on the part of the physician. For example, in order to perform an angioplasty dilation, the angioplasty balloon catheter must be positioned across the stenosis in the arterial site. The stenosis may be located in a tortuous portion of the coronary vasculature and, furthermore, the obstructive arterial disease may impede crossing the stenosis with the balloon portion of the angioplasty catheter. Thus, not all arterial obstructions can be successfully treated by present intravascular balloon catheter procedures because some arterial obstructions are not readily accessible to a balloon dilation catheter. Accordingly, there is often a need for intravascular catheters of very low profile that can be positioned in narrow, tortuous regions of a person's vasculature.

Another important consideration relating to intravascular procedures, such as angioplasty, relates to the exchange of various devices used to perform the procedures. Intravascular therapeutic and diagnostic devices come in various types and sizes suitable for the vessel size and location in which the treatment is to be performed. Sometimes, it becomes necessary to exchange a first therapeutic device for one of a different size after an unsuccessful attempt has been made to position the first device in the appropriate location. It may also become necessary to exchange therapeutic devices after the first device is successfully positioned in the desired location. This may be necessitated because it becomes apparent that the first device is the wrong size or configuration, or because it is determined that additional therapeutic or diagnostic procedures with a different size or type of device is required.

Several different types of catheter constructions have been developed for positioning intravascular therapeutic or diagnostic catheters through a patient's vasculature. One type of catheter design, commonly referred to as a fixed-wire type catheter, includes a non-removable wire with a flexible spring tip attached to a distal end of the intravascular catheter. The spring tip facilitates maneuvering the catheter to the desired vessel site. A disadvantage of the fixed-wire type catheter is that if it becomes necessary to exchange a first catheter for a second catheter, the maneuvering procedure must be repeated for the second catheter. As mentioned above, this can sometimes be a tedious and difficult procedure.

Another type of catheter design, referred to as an over-the-wire type catheter, includes a central lumen through the intravascular device that can accommodate a separate guide wire that is movable, and removable, in relation to the catheter to facilitate positioning the catheter in a remote vessel location over the guide wire. In the over-the-wire construction, the catheter typically includes a lumen adapted to receive the guide wire from a proximal end to the distal end of the device. The guide wire is initially loaded through the lumen of the over-the-wire catheter and extends out from the distal end thereof. Then, the guide wire and the intravascular catheter are advanced together and positioned in the vessel at the desired site. The guide wire may be advanced distally of the distal end of the catheter and steered, as necessary, to traverse tortuous passages of the vessel. The guide wire may then be withdrawn proximally through the lumen of the catheter or may be left in place extending from the distal end of the catheter during the procedure.

The over-the-wire type intravascular catheter facilitates exchanges because a first catheter can be exchanged for a second catheter without removing the guide wire. This allows an exchange of catheters without having to repeat the difficult and time consuming task of positioning the guide wire across the treatment site. In order to leave the distal end of the guide wire in place, it is preferred to maintain a hold on a proximal end portion of the guide wire during the exchange operation. One way to maintain such a hold is to use a guide wire having a sufficiently long length (e.g., 300 cm) so that the entire catheter can be completely withdrawn over the guide wire while maintaining a hold on a portion of the wire. A disadvantage of this method is that the long proximally extending portion of the guide wire may be in the way during the procedure. Another way to maintain a hold on a portion of the guide wire during an exchange operation is to use a guide wire extension. A disadvantage of this method is that not all guide wires are adapted to connect to an extension wire, and moreover, the step of connecting the guide wire to the extension wire can sometimes be tedious and difficult to perform.

A variation of the over-the-wire type catheter which facilitates the exchange of a first catheter with a second catheter is the single-operator exchange type construction. With the single-operator exchange type construction, a guide wire occupies a position adjacent and exterior to the intravascular catheter along proximal and middle portions of the catheter and enters into a short guide wire lumen of the catheter via an opening at a location close to a distal portion of the catheter. With this type of construction, the catheter can be positioned in the patient's vessel by positioning a guide wire in the desired location and advancing the catheter device over the wire. However, in the event it becomes necessary to exchange the catheter, the position of the guide wire can be maintained during withdrawal of the catheter without the use of a long guide wire (e.g., 300 cm) or an extension wire. Because the proximal end of the guide wire is exterior to the proximal end of the catheter, the proximal end of the guide wire can be held during withdrawal of the catheter so that the position of the distal end of the guide wire in the patient's vessel can be maintained. With this type of catheter, it is necessary that the distance from the distal end of the catheter to the proximal guide wire lumen entrance is less than the length of the guide wire that extends proximally out of the patient.

With known single-operator exchange type constructions, a catheter has at least one lumen extending over substantially the entire length of the catheter and a second guide wire lumen which begins at a location close to a distal portion of the catheter, usually proximal of the balloon and extending distally through the balloon, and opening at the distal end of the balloon. The additional lumen, and associated structure to form such lumen, impact the profile of the catheter in its distal region. This also impacts the flexibility and pushability of the catheter.

It is desirable to minimize the profile of the catheter in the distal region in order to more easily navigate through vascular restrictions. It is also desirable to maximize flexibility and trackability in order to better navigate through tortuous vasculature. It is further desirable to provide a means for blood perfusion during balloon dilation in order to minimize ischemic reaction.

In summary, the present invention may be described as a balloon dilation catheter including an elongate shaft with an inflatable balloon connected to the distal end. The catheter includes a proximal guide wire port and seal combination and a distal guide wire port and seal combination providing access for a guide wire to extend through the distal portion of the shaft and the balloon. The catheter further includes a blood perfusion tube passing through the interior of the balloon.

The present invention, together with further objects and advantages, will be best understood by reference to the following detailed description taken in conjunction with the accompanying drawings.

FIG. 1 is a side view, partially in section, of a preferred embodiment of a balloon dilation catheter of the present invention;

FIG. 2 is a longitudinal sectional view of a distal portion of the catheter shown in FIG. 1;

FIG. 3 is a cross-sectional view of the catheter taken along the line 3--3 in FIG. 1;

FIG. 4 is a cross-sectional view of the catheter taken along the line 4--4 in FIG. 2;

FIG. 5 is a cross-sectional view of the catheter taken along the line 5--5 in FIG. 2;

FIG. 6 is a cross-sectional view of the catheter taken along the line 6--6 of FIG. 2;

FIG. 7 is a cross-sectional view of the catheter taken along the line 7--7 of FIG. 2;

FIG. 8 is a cross-sectional view of the catheter taken along the line 8--8 of FIG. 2;

FIG. 9 is a longitudinal sectional view of a second preferred embodiment of a balloon dilation catheter;

FIG. 9A is a longitudinal sectional view of an alternative embodiment of the catheter shown in FIG. 9;

FIG. 10 is a cross-sectional view of the second preferred embodiment taken along the line 10--10 in FIG. 9;

FIG. 11 is a cross-sectional view of the second preferred embodiment taken along the line 11--11 in FIG. 9;

FIG. 12 is a side view, partially in section, of a third preferred embodiment of a balloon dilation catheter showing a deflated balloon;

FIG. 13 is a side view, partially in section, of the embodiment in FIG. 12 showing an inflated balloon;

FIG. 14 is a side view, partially in section, of a fourth preferred embodiment of a balloon dilation catheter showing a deflated balloon;

FIG. 15 is a side view, partially in section, of the embodiment in FIG. 14 showing an inflated balloon;

FIG. 16 is a side view, partially in section, of a fifth preferred embodiment of a balloon dilatation catheter;

FIG. 17 is a cross-sectional view of the catheter taken along the line 17--17 in FIG. 16;

FIG. 18 is a cross-sectional view of the catheter taken along the line 18--18 in FIG. 16;

FIG. 19 is a cross-sectional view of the catheter taken along the line 19--19 in FIG. 16;

FIG. 20 is a side view, partially in section, of a preferred embodiment of a single-operator exchange catheter having a distal catheter shaft section;

FIG. 21 is a longitudinal sectional view of a distal portion of the catheter shown in FIG. 20;

FIG. 22 is a cross-sectional view along line 22--22 of FIG. 21;

FIG. 23 is a cross-sectional view along line 23--23 of FIG. 21;

FIG. 24 is a longitudinal sectional view of a first alternative embodiment of the distal portion of the catheter shown in FIG. 20;

FIG. 25 is a longitudinal sectional view of a second alternative embodiment of the distal portion of the catheter shown in FIG. 20;

FIG. 26 is a longitudinal sectional view of a third alternative embodiment of the distal portion of the catheter shown in FIG. 20;

FIG. 27 is a cross-sectional view taken along line A--A in FIGS. 24, 25 and 26;

FIG. 28 is a cross-sectional view taken along line B--B in FIG. 24;

FIG. 29 is a cross-sectional view taken along line C--C in FIG. 25; and

FIG. 30 is a cross-sectional view taken along line D--D in FIG. 26.

The presently preferred embodiments and methodology described herein are applicable to coronary angioplasty procedures and are specifically described in the context of dilation balloon catheters. It should be understood, however, that the embodiments and methodology of the present invention may be adapted for use with other types of intravascular therapeutic devices, such as atherectomy catheters, as well as diagnostic catheters, such as ultrasonic catheters.

Referring to FIG. 1, a first embodiment of a single-operator exchange type intravascular apparatus is indicated generally at 10. The intravascular apparatus 10 includes a balloon dilation catheter 12 having an elongated shaft 14. A proximal portion 16 of the shaft 14 is adapted to extend outside the body of a patient during use, and a distal portion 18 of the shaft 14 is positionable intravascularly during use by manipulation of the proximal portion 16.

A dilation balloon 20 is located at and connected to the distal portion 18 of the catheter shaft 14. The balloon 20 can be formed from a polyolefin copolymer or other polymer material such as polyether-block-amide. For example, in one embodiment, the balloon 20 is formed of a polyolefin copolymer (such as that sold by DuPont under the tradename SURLYN as Resin No. 8527) using secondary treatment with 5 to 50 Mega-rad electron beam irradiation to enhance strength in the region of the balloon 20. Preferably, the balloon 20 has a proximal neck portion 22 defining a proximal opening 24, and a distal neck portion 26 defining a distal opening 28. The proximal neck portion 22 preferably has an outer diameter of about 0.040 inches and an inner diameter of about 0.034 inches. The distal neck portion 26 preferably has an outer diameter of about 0.030 inches and an inner diameter of about 0.025 inches.

The distal portion 18 of the shaft 14 extends into the proximal opening 24 in the balloon 20 and is preferably connected to the proximal neck portion 22. The shaft 14 includes an inflation lumen 30 extending therethrough and has a proximal opening 32 and a distal opening 34. A manifold 36 is connected to the proximal portion 16 of the shaft 14 and the dilation balloon 20 is in fluid flow communication with the inflation lumen 30. Inflation fluid is conveyed via the lumen 30 from the manifold 36 to inflate the balloon 20 and therefore dilate a vessel in a conventional manner known in the art.

In a preferred embodiment, the shaft 14 has a length of approximately 135 cm. The proximal portion 16 of the shaft 14 is preferably made of stainless steel hypodermic tubing and the distal portion 18 is made of a relatively flexible polymeric material such as a polyolefin copolymer or polyethylene. This type of shaft is disclosed in U.S. patent application Ser. No. 07/833,099, filed Feb. 10, 1992, now abandoned, the disclosure of which is specifically incorporated herein by reference. In order to minimize the profile of the distal portion 18 of shaft 14, the shape of the shaft 14 and lumen 30 converges from a circular cross-section at the proximal portion 16 thereof (FIG. 3) to a kidney-shaped cross section at the distal portion thereof (FIGS. 4-6). An upper wall 38 and a lower wall 40 of the shaft 14 converge distally of the distal opening 34 in the lumen 30 and extend across the balloon 20 to a position adjacent the distal neck portion 26 of the balloon 20. Preferably, a stiffening wire 42 extends distally from a distal end of the steel tubing and is attached to a distal end of the balloon 20 as disclosed in the No. '113 patent to provide additional support for the manipulation of the catheter 12. Alternatively, the stiffening wire 42 can be attached to an underside of the upper wall 38 of the shaft and extend to approximately the center of the balloon 20 as shown in FIGS. 1 and 2.

To facilitate the operation and exchange of the components of the intravascular apparatus 10, an elongated guide tube 44 is adapted to extend through the proximal and distal openings 24 and 28 of the balloon 20 for slidable movement relative to the balloon 20 during use. The guide tube 44 also has an inner chamber 50 extending therethrough from a proximal end 52 to a distal end 53 thereof for slidably receiving a conventional guide wire 54. The guide tube 44 has a sufficient length, preferably about 135 cm, so that a proximal portion 46 of the guide tube 44 can extend outside the body of a patient during use while a distal portion 48 extends distally of the balloon 20. Preferably, the guide tube 44 is approximately the same length as a conventional catheter.

The guide tube 44 may also be provided in different sizes to accommodate different size devices. For example, the guide tube 44 can be provided with an inner diameter of 0.017 inches and an outer diameter of 0.020 inches for use with a 0.014 inch guide wire. For use with a 0.010 inch guide wire, the guide tube 44 may be provided with an inner diameter of 0.013 inches and an outer diameter of 0.016 inches.

Preferably, the guide tube 44 is made of a polymeric material, such as polyimide, and has a low friction coating, such as Teflon.RTM., on both the inner and outer surfaces thereof. A coating on the inner surface enhances guide wire movement through the chamber 50, and a coating on the outer surface enhances movement of the guide tube 44 through a guiding catheter, a vessel, or the balloon 20. Alternatively, the guide tube 44 can be made of other materials, such as polyurethane, polyester, or other polymers. The guide tube 44 can also be made of a polyimide-teflon composite material, or reinforced with wire or a braid of metal or plastic or other materials.

To provide greater stiffness at the proximal portion 46 of the guide tube 44 compared to the distal portion 48, the pitch of a wound reinforcing wire can be varied a desired amount along the length of the guide tube 44. The variable pitch wire can provide increased stiffness at the proximal portion 46 of the guide tube 44 to facilitate manipulation of the entire guide tube 44. The variable pitch wire can also provide sufficient flexibility at the distal portion 48 of the guide tube 44 to allow the guide tube 44 to easily follow the guide wire 54 through a vessel. Also alternatively, the coatings may be made of other materials such as a hydrophilic or silicone coating. In addition to or instead of the low friction coating, a metallic or foil coating may also be incorporated on the inner or outer surface of the guide tube 44.

The guide wire 54 has a sufficient length, preferably about 160-190 cm, so that a proximal portion 56 of the guide wire 54 can extend outside the body of a patient from an opening in the proximal end 52 in the guide tube 44 while a distal portion 58 extends distally from an opening in the distal end 53 of the guide tube 44. The proximal portion 56 of the guide wire 54 can also extend out of an opening in the guide tube located distally of the proximal end 52 of the guide tube 44. In addition, the guide wire 54 can have an outer diameter between 0.008 and 0.022 inches, although conventional guide wires typically have a diameter of 0.010, 0.014 or 0.018 inches.

In a first embodiment, a proximal seal member 62 is sealingly connected to the proximal neck portion 22 of the balloon 20 and a distal seal member 64 is sealingly connected to the distal neck portion 26 of the balloon 20. The proximal and distal seal members 62 and 64 have passageways 66 and 68 therethrough for slidably receiving the guide tube 44. The seal members 62 and 64 are preferably configured as collars and are made of a polymeric material, such as polyimide, polyurethane, polyester or the like. An upper portion of the proximal seal member 62 is attached to the curved bottom wall 40 of the catheter shaft 14, and a lower portion is attached to the proximal neck portion 22 of the balloon 20. The entire periphery of the distal seal member 64 is attached to the distal neck portion 26, and a distal end 70 of the shaft 14 is attached to a top portion of the distal seal member 64 proximally of the neck portion 26. In use, the distal portion 48 of the guide tube 44 is adapted to extend distally from an end 71 of the distal seal member 64 while the proximal portion 46 is outside the body of a patient. Preferably, the outer diameter of the guide tube 44 is only slightly smaller than the inner diameters of the proximal and distal seal members 62 and 64 to create a tolerance fit which allows slidable movement of the guide tube 44 through the seal member passageways 66 and 68. When the balloon 20 is inflated with fluid, the tolerance fit between the guide tube 44 and the proximal and distal seal members 62 and 64 inhibits inflation fluid from exiting the balloon 20.

In addition, the distal seal member 64 preferably extends proximally into the balloon 20 and has an expandable, tubular valve member 72 made of an elastomeric material such as TECOTHANE or the like. As shown in dashed lines in FIG. 2, the valve member 72 expands radially inward against the guide tube 44 when the balloon 20 is inflated to further seal any space between the guide tube 44 and the distal seal member 64. A valve member of similar construction can also be incorporated into the proximal seal member 62 if desired.

FIGS. 9-19 illustrate alternative embodiments of the present invention. Since these embodiments are similar to the previously described embodiment, similar parts appearing in FIGS. 9-15 are represented by the same, corresponding reference numeral, except for the corresponding letter in the numerals of the latter.

In the embodiment shown in FIGS. 9-11, a pair of split O-ring type seals are provided to prevent inflation fluid from exiting the balloon 20a. An upper portion of a proximal split O-ring 80 is attached to the curved bottom wall 40a of the catheter shaft 14a, and a lower portion is attached to the proximal neck portion 22a of the balloon 20a. The entire periphery of a distal O-ring 82 can be attached to the distal seal member 64a as shown in FIG. 9 or bonded directly to the distal neck portion 26a of the balloon 20. The split O-rings 80 and 82 are preferably made of a relatively soft durometer urethane material or the like and can be pre-formed or molded into the balloon 20a.

In a molding operation, a polyurethane adhesive or the like can be injected into a shaped mold temporarily positioned in the neck portion of the balloon 20a. Although the contact surfaces of the O-rings 80 and 82 are shown as rounded surfaces, the O-rings can be formed in any desired shape to facilitate slidable movement of the guide tube 44a while providing an effective seal when the balloon 20a is inflated. The shape and material of the O-ring allows greater deformation as a result of pressure from the inflation fluid, which may provide a more effective seal. Moreover, the "single point" contact of the proximal and distal O-rings 80 and 82 with the guide tube 44a may facilitate advancement and withdrawal of the catheter 12a over the guide tube 44a because the decreased contact area tends to reduce frictional forces acting on the guide tube 44a.

In the embodiment shown in FIGS. 12-13, the guide tube 44b is configured with an enclosed, deformable bladder-type sheath 84 surrounding a portion thereof. The sheath 84 has a constant volume of fluid therein (not shown) and is approximately the same length as the distance between the proximal and distal seal members 62b and 64b of the balloon 20b. Prior to inflation of the balloon 20b, the guide tube 44b is advanced or withdrawn until proximal and distal end portions 86 and 88 of the sheath 84 are substantially aligned with the proximal and distal seal members 62b and 64b (FIG. 12). When the balloon 20b is inflated with fluid, the fluid in the sheath 84 is displaced outwardly toward the end portions 86 and 88 (FIG. 13). As a result, the volume of space occupied by the end portions 86 and 88 increases such that the end portions bear against the seal members 62b and 64b to create an effective seal which prevents the inflation fluid from exiting the balloon 20b.

Alternatively, the sheath 84b can be provided in the form of spaced apart proximal and distal sheaths 90 and 92 surrounding the guide tube 44c as shown in FIGS. 14 and 15. The distance between the sheaths 90 and 92 is approximately the same as the distance between the seal members 62c and 64c. The sheaths 90 and 92 are aligned with the corresponding seal members 62c and 64c prior to inflation of the balloon 20c (FIG. 14), and the inflation fluid displaces the fluid in the sheaths 90 and 92 outwardly to create a seal between the sheaths 90 and 92 and the corresponding seal members 62c and 64c. In either of the embodiments shown in FIGS. 12-15, the seal members can be eliminated and the sheaths can be configured to bear directly against the corresponding neck portions of the balloon when displaced by the inflation fluid.

Alternatively, a bladder-type valve member which surrounds the guide tube 44 and expands when filled with fluid can provide an active seal. Valve members of this type are disclosed in U.S. Pat. No. 5,085,636, issued Feb. 4, 1992, the disclosure of which is specifically incorporated herein by reference. Such a seal could be activated by the inflation fluid which fills the balloon 20 or by a separate flow of fluid through a micro-tube connected to the bladder.

In any of the embodiments described herein, the proximal and distal seal members can be configured to slidably receive and provide an effective seal around a guide wire without the use of a guide tube (see, e.g., FIG. 9A). One advantage of this configuration may be the reduced profile of the balloon 20 resulting from the elimination of an inner tube inside the balloon 20. Such a configuration may also facilitate the flow of a radiopaque dye solution which is typically introduced into the vessel after an angioplasty procedure to determine whether an acceptable blood flow has been established through the vessel. When a 0.014 inch guide wire is used, the proximal neck portion 22 preferably has an outer diameter of about 0.036 inches and an inner diameter of about 0.030 inches. The distal neck portion 26 preferably has an outer diameter of about 0.025 inches and an inner diameter of about 0.020 inches. Thus, the distal and proximal seals inhibit fluid from exiting the balloon 20 without separating the movable guide wire from the inflation fluid in the balloon.

FIGS. 16-19 illustrate yet another embodiment of the present invention. In this embodiment, the shaft 14d has a relatively large diameter body portion 100 and a smaller diameter distal end portion 102 which extends through the proximal and distal openings 24d and 28d in the balloon 20d. Preferably, the juncture of the body portion 100 and the distal end portion 102 is defined by a tapered shoulder 103 adjacent the balloon 20d. The distal end portion 102 of shaft 14d is sealingly attached to the proximal and distal neck portions 22d and 26d of the balloon 20d. The balloon 20d is inflated by conveying fluid via the inflation lumen 30d of the shaft 14d through a plurality of openings 104 formed in the distal end portion 102 of the shaft. Instead of slidably attaching the guide tube 44d to the balloon 20d and positioning the entire guide tube 44d outside the shaft 14d, a portion of the guide tube 44d is movably positioned within a distal portion of the inflation lumen 30d of shaft 14d. Because the guide tube 44d is positioned within the reduced diameter shaft lumen 30d rather than outside the shaft 14d, the profile of catheter 12d is minimized to allow insertion into relatively small vessels. The constant outer diameter of the distal end portion 102 of the shaft 14d also may provide a better joint between the balloon 20d and the shaft 14d.

An opening 106 is provided in the body portion 100 of the shaft 14d, preferably about 10-30 cm proximally from the balloon 20d, for receiving the guide tube 44d. The guide tube 44d is guided by an inner core 108 which extends distally a relatively short distance, preferably about 5-15 mm, into the inflation lumen 30d from the opening 106. An end portion 110 of the core 108 is flared to direct the guide tube 44d into the core 108 when the guide tube 44d is inserted in a proximal direction through the distal end portion 102 of the shaft 14d. To prevent fluid from exiting through the core 108 and out the opening 106, a seal member 110 is sealingly connected to the core 108. The seal member 110 is preferably a split O-ring type seal which is described in more detail above. A split O-ring type seal member 112 can also be provided in the distal neck portion 26d for sealingly engaging the guide tube 44d.

Alternatively, the opening 106 and core 108 of the shaft 14d, along with the seal members 110 and 112, can be configured to slidably receive a guide wire or other intravascular device without the use of the guide tube 44d. The elimination of the guide tube would allow the shaft to be configured with a smaller outer diameter, thus reducing the profile of the catheter.

Another preferred embodiment of a single-operator exchange catheter of the present invention is depicted in FIGS. 20-23. With this embodiment, the catheter 12 includes a proximal tubular member 14, a transition tube 200, and a distal catheter shaft section 202. The distal catheter shaft section 202 is preferably the only tubular member extending distally beyond the distal end of the transition tube 200 through the balloon 20 with a distal opening 204 at the distal end of the catheter 12. By the use of active and/or passive seals and the configuration described below, the distal catheter shaft section 202 provides a lumen 206 for both slidably receiving the guide wire 54 (whether incorporating a guide tube or guide wire only) and for providing fluid communication for inflation fluid from the distal area of the transition tube 200 to the inside of balloon 20.

The proximal tubular member 14 includes at least one tubular section and has a lumen 208 extending therethrough. The proximal tubular member 14, as with the embodiments described above, extends distally from a manifold 36. The proximal tubular member 14 is preferably a stainless steel hypotube. As shown in FIG. 20, the transition tube 200 preferably has a proximal end 210 connected proximate to the distal end 212 of the proximal tubular member 14. The transition tube 200 has a lumen 201 in fluid communication with the lumen 208 of the proximal tubular member 14. The transition tube 200 further includes a radial port 214. The radial port 214 is created by boring a hole or otherwise forming a passage through the side wall of the transition tube 200. Although not preferable, the proximal tubular member 14 and transition tube 200 could be a single tubular member or main tubular member and thus the radial port 214 would be through the side wall of the main tubular member 14.

The distal catheter shaft section 202, as best depicted in FIG. 21, has a proximal end 216 connected to the radial port 214. A lumen 206 extends through the distal catheter shaft section 202 and extends distally beyond the distal end 218 of the transition tube 200 to the distal end 204 of the catheter 12.

The distal end 218 of the transition tube 200 is sealingly connected to the outside surface of the distal catheter shaft section 202. The transition tube 200 and distal catheter shaft section 202 are preferably manufactured from a polymer such as polyethylene. Bonds between these polymeric tubular members are preferably accomplished through thermal welding, however it is recognized that adhesives may also be utilized as described for previous embodiments.

The distal catheter shaft section 202 further includes at least one first inflation hole 220 which extends through the wall thereof intermediate between the radial port 214 and the distal end 218 of the transition tube 200.

The balloon 20 has a proximal end 230 and a distal end 232 sealingly connected to the distal catheter shaft section 202 at a location spaced distally from the distal end 218 of the transition tube 200. The distal catheter shaft section 202 further includes at least one second inflation hole 222 through the wall thereof intermediate the ends of the balloon 230, 232.

With the above structure, the lumen 201 of the transition tube 200 is in fluid communication with the interior of the balloon 20 through the first inflation hole 220, a portion of the lumen 206 of the distal catheter shaft section 202 and the second inflation hole 222.

A core member 234 can be disposed within the lumens 208, 201 of the proximal tubular member 14 and the transition tube 200 over at least a portion of their lengths. The core member 234 is preferably a stainless steel wire. In one embodiment, the core member 234 extends from proximate the distal end 212 of the proximal tubular member 14 distally to a point proximate the radial port 214.

Because a single tubular member, namely the distal catheter shaft section 202, eliminates the need for a separate guide wire lumen and inflation lumen from a point proximal to the balloon through the balloon, the profile of a catheter designed in accordance with this embodiment is smaller and allows for better access to smaller vessels and better flow of fluid around the catheter 12, such as blood or radiopaque contrast fluid. To prevent leakage of inflation fluid proximal to the first inflation hole 220 and distal to the second inflation hole 222, means for sealing around the guide wire disposed within the lumen 206 of the distal catheter shaft section 202 are provided. As with previous embodiments, many combinations of seals are possible.

In one embodiment, depicted in FIGS. 20-23, a first 240 and a second 242 active seal means are provided for limiting the egress of inflation fluid. The first active seal means 240 is disposed within the lumen 206 of the distal catheter shaft section 202 between the radial port 214 and the first inflation hole 220. This seal prevents or reduces leakage of inflation fluid out the port 214. The second active seal means 242 is disposed within the lumen 206 of the distal catheter shaft section 202 between the distal end 204 of the catheter and the second inflation hole 222. This seal prevents or reduces leakage out the distal end of the catheter. The active seal means 240, 242 are preferably sections of flexible tubing extending across a gap in the length of the distal catheter shaft section 202. A preferable material of construction is and elastomeric material such as TECOTHANE or PEBA.

In an alternative embodiment, the first 240 and second 242 active seal means could incorporate an elastomeric material which extends across a gap in the length of the distal catheter shaft section 202 and be connected to the inside surface of the distal catheter shaft section 202. With this design, a pressure permeable, longitudinally stiff member can be extended over the gap and affixed to the outside surface of the distal catheter shaft on each side of the gap. The pressure permeable, longitudinally stiff member can provide additional stiffness in the region of the active seals which can assist pushability of the catheter 12.

First and second passive seal means 244, 246 can also be included, as depicted in FIGS. 20-21. The passive seals assist the active seals in preventing or reducing the egress of inflation fluid. The first passive seal means 244 is disposed within the lumen 206 of the distal catheter shaft section 202 between the radial port 214 and the first inflation hole 220. The second passive seal 246 is also disposed within the lumen 206 of the distal catheter shaft section 202, however, between the distal end 204 of the catheter 12 and the second inflation hole 222. The passive seal means are preferably O-ring seals manufactured from a polymeric material such as polyurethane resin. Other manufacturing molding materials and methods may be utilized.

FIGS. 24-30 show alternative embodiments including a perfusion tube which permits blood to pass across the treatment site while the balloon is inflated. The alternative embodiments shown in FIGS. 24-30 are substantially the same as the embodiment described with reference to FIGS. 20 and 21 with the following exceptions. The methods of use are also substantially the same except that prolonged balloon inflation may be possible given the incorporation of blood perfusion capabilities.

Refer to FIG. 24 which shows a first alternative embodiment 300 of the distal portion of the catheter shown in FIG. 20. Distal portion 300 includes a perfusion tube 301 traversing the interior of the balloon 20. The perfusion tube 301 allows blood to continue to flow across the treatment site when the balloon 20 is inflated. In particular, the perfusion tube 301 permits blood to enter the perfusion inlet 303, flow through the perfusion lumen 309 and exit the perfusion outlet 304. The perfusion outlet 304 may be laterally facing holes (as shown in FIG. 24) or a distally facing opening (as shown in FIG. 25) or a combination thereof.

The perfusion tube 301 includes a proximal section which is crimped into a partial crescent shape as best shown in FIG. 27. The perfusion tube 301 returns to a circular cross-section distal of the seal 305 as best shown in FIG. 28. FIGS. 27 and 28 show cross-sectional views taken at A--A and B--B respectively in FIG. 24. The distal shaft 202 may be adhesively secured in the recess of the crimped portion of the perfusion tube 301. The proximal balloon waist 230 is adhesively secured to both the distal shaft 202 and the crimped portion of the perfusion tube 301 to provide a sealed connection. The distal balloon waist 232 may be adhesively secured to the distal portion of the perfusion tube 301. The distal end of the distal shaft 202 may be adhesively secured to the distal end of the perfusion tube 301 distal of the perfusion outlet holes 304. The adhesive 308 used to connect the distal end of the distal shaft 202 to the distal end of the perfusion tube 301 may be tapered in the distal direction to provide a smooth transition.

The distal shaft 202 includes a series of distal inflation holes 222 to provide a fluid path into the interior of the balloon. A distal guide wire seal 305 is mounted to the distal end of the distal shaft section 202 distal of the inflation holes 222. The distal shaft section 202 continues past the seal 305, traverses through the perfusion tube adjacent the distal end of the crimp 302 and extends to the distal end of the perfusion tube 301. The distal shaft section 202 may be adhesively secured and sealed to the perfusion tube 301 adjacent the distal end of the crimp 302.

Alternatively, perfusion tube 301 could retain its circular shape along its entire length. Distal shaft 202 may be contained within the interior of perfusion tube 301. Distal shaft 202 would be attached to the inner surface of perfusion tube 301 in at least one location. At least two access holes through the wall of perfusion tube 301 would be utilized; one to communicate inflation medium to the seal 305, and the other to communicate inflation media to the balloon.

The distal seal 305 may utilize an active seal 306 in combination with an o-ring passive seal 307. Although the arrangement of the o-ring seal 307 and the active seal 306 is different from the arrangement discussed with reference to FIGS. 20 and 21, the same dimensions, materials and operating principles apply. It is contemplated the seal arrangement 305 as shown in FIG. 24 may incorporate integrally formed active 306 and passive 307 seals made of a polymer such as TECOTHANE and formed by a molding process.

Refer now to FIG. 25 which shows a second alternative embodiment 310 of the distal portion of the catheter shown in FIG. 20. The second alternative embodiment 310 of the distal portion is identical to the first alternative embodiment 300 with the following exceptions.

The distal shaft section 202 in the second embodiment 310 terminates at the distal end of the crimp 302 and is adhesively secured thereto. This provides a larger perfusion lumen 309 distal of the seal 305. The increase in cross-sectional area of the perfusion lumen 309 is best shown in FIG. 29 as compared to FIG. 28. FIGS. 27 and 29 show cross-sectional views taken at A--A and C--C respectively in FIG. 25. The perfusion outlet 314 is a distally facing opening since the distal end of the perfusion tube 301 cannot be bonded to the distal end of the distal shaft section 202.

Refer now to FIG. 26 which shows a third alternative embodiment 320 of the distal portion of the catheter shown in FIG. 20. The third alternative embodiment 320 of the distal portion is identical to the first alternative embodiment 300 with the following exceptions.

The third alternative embodiment 320 incorporates a perfusion tube 321 which is crimped into a partial crescent shape along its entire length. FIGS. 27 and 30 show cross-sectional views taken at A--A and D--D respectively in FIG. 26. The distal shaft 202 is disposed in the recess of the crimp and is bonded at its distal end to the distal balloon waist 232 and the distal end of the perfusion tube 321 in a similar manner as the proximal balloon waist 230 bond site. Blood enters the perfusion tube 321 at the perfusion inlet 323, flows through the perfusion lumen 309 and exits at the distally facing perfusion outlet 324.

It is contemplated that alternative bonding methods (e.g., thermal bonding, ultrasonic bonding, etc.) may be utilized in place of adhesive bonding. In addition, it is contemplated that the individual tubes (e.g. distal shaft 202 and perfusion tube 301/321) may be integrally formed by multi-lumen extrusion methods. It is further contemplated that a reinforcing coil disposed inside the perfusion tube 301/321 may be utilized to provide added hoop strength during balloon inflation.

Alternative methods of sealing onto a guide wire or guide tube are also contemplated. Examples of alternate means of sealing onto a guide wire are disclosed in commonly-assigned U.S. Pat. No. 5,085,636 to Burns which is specifically incorporated herein by reference. Another alternative sealing mechanism is contemplated which incorporates the use of heat-activated shape memory materials.

A first heat-activated seal embodiment incorporates a coil made of a shape memory alloy disposed about a flexible polymer tube. The flexible polymer tube may be rigidly connected to the shaft such that a guide wire may pass through the lumen of the tube. The shape memory coil may be disposed about the exterior of the polymer tube or embedded in the wall of the tube.

The shape memory coil responds to elevated temperatures by contracting radially and longitudinally. The radial contraction, in turn, compresses the polymeric tube onto the guide wire and forms a seal therebetween. The elevated temperature may be achieved by ohmic heating due to electrical currents passing through the shape memory coil. The electrical currents, in turn, may be induced by a primary coil outside the body or by direct electrical connection using wire leads extending through the catheter.

A second heat-activated seal embodiment utilizes a shape memory polymer with a glass transition temperature above human body temperature. The shape memory polymer may be formed in the shape of a tube with a guide wire lumen extending therethrough. Preferably, the mechanical strength of the shape memory polymer varies substantially across the glass transition temperature. The diameter of the guide wire lumen should be slightly smaller than the diameter of the guide wire when the shape memory polymer is at room temperature. A heating element (such as an electrical coil made of heater wire) is used to heat the shape memory polymer at or near the glass transition temperature. The shape memory polymer increases in size and becomes relatively soft at the elevated temperature, thus allowing the guide wire to move freely therethrough. The shape memory polymer is maintained at that temperature while the catheter is manipulated over the guide wire. When it is desired to seal onto the guide wire, the heating is discontinued and the shape memory polymer tube shrinks down onto the guide wire and becomes relatively hard. A preferred shape memory polymer is MM-5520 polyurethane available from Mitsubishi having a glass transition temperature of about 55.degree. C.

It is also contemplated that lubricious coatings may be applied to any of the seals to reduce the friction between the seal and the guide wire passing therethrough. Substantially reducing the friction between the guide wire and the seal may eliminate the need to use an active seal, since a passive interference fit seal may be made substantially tighter without compromising guide wire movement. For example, a ceramic coating may be applied to an elastomeric seal interference fit seal to provide free guide wire movement. The ceramic coating has been demonstrated to reduce friction of elastomeric materials by a factor ranging from 3 to 15. Spire Corporation has the capability of coating silicon rubber sheets with such a ceramic material and may be a suitable vendor for coating the guide wire seals discussed herein.

In operation of the intravascular apparatus 10, intravascular access is initially made in a conventional manner. If the procedure is a percutaneous translumenal angioplasty (PTCA) procedure, access is made via the femoral artery. A conventional introducer and guiding catheter (not shown) can be employed in a manner that is well known in the art. When used with the described embodiments of the present invention, a guiding catheter should have a lumen of sufficient size to accommodate the catheter 12, guide tube 44 and guide wire 54.

To initially position the intravascular apparatus 10 in a patient's vessel, the guide wire 54 is preferably inserted into the guide tube 44 while the entire guide tube is outside the body such that the distal tip portion 58 of the guide wire 54 extends beyond the guide tube 44. The combination of the guide wire 54 and guide tube 44 is then advanced to a desired location in a vessel, and the catheter 12 is advanced over the guide tube 44. The guide wire 54 can be inserted into the vessel prior to advancement of the guide tube 44 over the guide wire, or the guide tube 44 can be inserted into the vessel prior to advancement of the guide wire 54 through the guide tube 44. If the catheter 12 is configured to receive the guide wire 54 without the guide tube 44, the guide wire 54 can be advanced to a desired location in a vessel in a "bare wire" technique and the catheter 12 can be passed over the guide wire 54.

Preferably, the combination guide wire 54 and guide tube 44 are advanced until the distal portions 48 and 58 thereof reach a distal end of the guiding catheter. The guide wire 54 may be further advanced in the vessel alone, or the guide tube 44 may be advanced along with the guide wire 54. Thus, the distal portion 48 of the guide tube 44 can provide additional support for the distal portion 58 of the guide wire 54 when desired. For example, when the guide wire 54 is initially advanced alone, it may become difficult at some point to further advance the guide wire because it does not have sufficient stiffness for effective manipulation. The guide tube 44 can then be advanced to support the guide wire 54 and assist its advancement in the vessel. Thus, using the guide tube 44 may avoid having to exchange the guide wire 54 for another guide wire having a larger diameter. If an exchange is required because the size or configuration of the guide wire 54 is inappropriate for further advancement in the vessel, the guide tube 44 is advanced until the distal end 53 reaches a distal end 60 of the guide wire 54. The guide wire 54 is withdrawn from the guide tube 44, and a desired bend can be formed in the distal portion 58 of the guide wire 54 or another guide wire can be obtained. The newly configured guide wire is then advanced through the guide tube 44 to the previously attained position.

The guide tube 44 can also be used to straighten a bend in the distal portion 58 of the guide wire 54 while inside a vessel. As noted above, the distal portion 58 of the guide wire 54 is often bent a desired amount prior to insertion into the body of a patient to allow manipulation of the guide wire 54 through various vessels. The distal portion 58 of the guide wire 54 may also bend as a result of advancement of the guide wire 54 when movement of the distal tip is impeded in the vessel. If the bend is inappropriate for further advancement of the guide wire 54 to the desired location in the vessel or for advancement into a different vessel, the guide tube 44 can be advanced over the guide wire 54 to straighten the distal portion 58 a desired amount. In addition, the guide tube 44 can be advanced over the guide wire 54 after the guide wire is advanced past a stenosis in the vessel to pre-dilate the stenosis before insertion of the balloon 20. The guide wire 54 can also be moved within the guide tube 44 when the balloon 20 is inflated inside a vessel.

As best shown in FIG. 1, a substantial portion of the guide tube 44 and guide wire 54 is positioned outside the catheter shaft 14 to allow a single-operator exchange of the catheter 12 for a second catheter. When a different size or configuration catheter is required, the catheter 12 is withdrawn so that the balloon 20 passes over the guide tube 44 while an operator maintains a hold on the proximal portion 46 of the guide tube 44 and the proximal portion 56 of the guide wire 54. The balloon of a second catheter can then be advanced over the guide tube 44 to position the second catheter in the same location previously attained by the first balloon catheter 12. This single-operator exchange type configuration allows the operator to maintain a hold on the guide tube 44 and guide wire 54 without using an extension or a relatively long guide tube and guide wire.

The guide tube 44 therefore provides for the independent or substantially contemporaneous exchange of the guide wire 54 and the catheter 12. When an exchange of the guide wire 54 is required, the guide wire 54 is withdrawn through the guide tube 44 and replaced with a second guide wire. Thus, the guide wire 54 can be exchanged before the catheter 12 has been inserted in the vessel, while the catheter 12 remains in the vessel, or after the catheter 12 has been withdrawn. Likewise, the catheter 12 can be exchanged while the guide wire 54 remains in the vessel or after the guide wire 54 has been withdrawn. In either procedure, the position of the guide tube 44 is maintained in the vessel by holding onto the proximal portion 46 of the guide tube.

Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. As such, it is intended that the foregoing detailed description be regarded as illustrative rather than limiting and that it is the following claims, including all equivalents thereof, which are intended to define the scope of the invention.