MX2008007971A - Balloon catheter with centralized vent hole - Google Patents

Abstract

A system and method providing a catheter assembly for engaging a stenosis. The assembly includes a catheter defining a first lumen and a second lumen spaced apart and disposed about a longitudinal axis. The catheter includes an opening in communication with the first lumen to define a flow path having an angle incident to the longitudinal axis. A first marker;and a second marker disposed on the catheter are spaced equidistantly from the opening. The assembly includes a balloon having a first end and a second end each sealed about the catheter and equidistantly from the opening to define a holding volume therebetween. The opening is disposed within the holding volume thereby placing the first lumen in sealed fluid communication with the holding volume. In a preferred embodiment, the catheter assembly includes a stent disposed about the balloon, and the balloon is configured to engage the stent with a stenosis.

Description

GLOBE CATETER WITH CENTRALIZED VENTILATION HOLE Priority Data and Incorporation by Reference This application claims the priority benefit of the priority of Provisional Patent Application No. 60 / 752,878, filed on December 23, 2005, it is hereby incorporated by reference in its entirety.

Technical Field The present invention relates generally to balloon catheter assemblies for use in angioplasty and stent delivery procedures (molded apparatus, for maintaining a skin graft in position or for supporting tubular structures for anastomosis). In particular, the present invention provides a system and method for the delivery of a balloon catheter to a stenosed blood vessel (with stenosis) and inflation of the balloon of expansion to expand a stent implant and / or the stenosed blood vessel.

Background A large number of balloon catheters have been devised for angioplasty and stent delivery procedures. Commonly, a guidewire is first introduced percutaneously into a patient's vascular system, advanced, and then directed toward the patient. site of a stenosis. A dilatation balloon or catheter is then advanced through the guidewire until the balloon is placed within the stenosis so that after inflation, the balloon will compress the stenosis through dilation of the blood vessel to re-establish an adequate trajectory of blood flow beyond the stricture. To facilitate the distribution of compression pressure along the length of the stenosis lesion, it is preferred that the dilatation balloon be centered in relation to the stenosis so that it fully engages the lesion. Balloon dilation catheters have also been used in the stent delivery where the stent is disposed around the balloon and inflated at the site of the stenosis. The catheter operators seek the exact deployment of the stent directly on the diseased tissue of the vessel in order to prevent migration of the stent to either side of the diseased tissue thus avoiding or reducing the opportunity to leave some untreated diseased tissue. Accurate deployment of the stent is also desirable in order to avoid adversely affecting healthy tissue. Erroneous placement of the stent may occur due to the specific inflation dynamics experienced by the expandable balloon when the stent is deployed. Known stent delivery catheters inflate the balloon portion of the catheter preferentially from either the distal or proximal end of the balloon. During inflation, the expanded balloon may form a non-asymmetric growth or inflation wave that is said to direct or suspends the stent so that it progressively opens from one end to the other along the front of the inflation wave. The wave can sometimes cause the stent to prematurely disengage from the balloon. This form of balloon inflation is referred to as "end-to-end" preferential inflation. End-to-end balloon inflation can also cause the deployment of the stent to move longitudinally away from its intended delivery site, thus potentially and ineffectively treating the diseased lesion within the patient's vasculature. Known balloon dilation catheters used in conjunction with stent deployment and / or other applications are shown and described in several US Patents. which include: Patents of E.U.A. Nos. 6,136,011; 5,908,448; 5,226,880, 5,176,619; 4,811,737; 5,409,495; 5,334,148; 5,169,386; and 3,939,820. In the patent of E.U.A. No. 6,592,568 describes an inflation technique for average inflation of the balloon using an intermediate balloon within a stent delivery dilation balloon to concentrate a bolus of fluid medially for distribution through the balloon of expansion. The intermediate balloon may be either capable of breaking or otherwise providing a controlled leakage of fluid to release fluid into the balloon of expansion. However, this technique adds complexity to the procedure by requiring bursting or controlled leakage of an intermediate balloon. Another complex stent delivery and delivery device it is shown and described in the patent of E.U.A. No. 6,203,558, in which a stent is arranged around an inflation balloon. The inflation balloon is arranged around a catheter assembly having an internal arrow and an outer arrow. The inflation balloon is inflated from its proximal end through the supply of a pressurized fluid that flows between the internal and external arrows. The deployment device also includes an expandable security device disposed around the internal arrow and disposed within the inflation balloon. The inner arrow has an individual lumen to carry a guide wire and fluid to expand the safety device. To expand the safety member, the fluid is discharged from the individual lumen through a valve disposed along the internal arrow and centrally located within the safety member. For example, see Figure 34 of the '558 Patent. The expanded security member ensures the coupling between the inflation balloon and the stent. Another patent, patent of E.U.A. No. 6,648,854, also discloses an individual lumen balloon tip catheter for inflating a balloon having an operating pressure of about one atmosphere. The catheter effectively uses an individual lumen to carry both a guide wire and inflation fluid. However, when using balloons having higher operating pressures, an individual lumen device may not be sufficient to provide adequate pressure to inflate the balloon.

Description of the Invention A preferred embodiment according to the present invention provides a catheter assembly for coupling a stenosis. The assembly includes a catheter that includes a wall having a proximal end and a distal end along a longitudinal axis. The wall preferably has an inner surface and an outer surface, wherein the inner surface defines a first lumen and a second lumen spaced apart and disposed about the longitudinal axis. The wall preferably defines an opening that extends between the inner surface and the outer surface. The opening is in communication with the first lumen to define a flow path having an angle incident to the longitudinal axis. The outer surface also preferably includes a first radiopaque and / or radiographic marker; and a second radio-opaque and / or radiographic marker separates from the other along the longitudinal axis so that it is substantially equidistant from the opening. The assembly also preferably includes a balloon having a first end and a second end defining a support volume therebetween. The first end and the second end preferably are sealed around the outer surface. The opening is disposed within the support volume thereby placing the first lumen in sealed fluid communication with the support volume. The first and second ends of the balloon are also preferably substantially and equidistantly spaced apart around the opening along the longitudinal axis.

The Applicant recognizes that it is desirable to have an apparatus and method for centrally locating the balloon dilatation catheter assembly within a region with stenosis to ensure proper coupling between the stenosis and the balloon dilatation. The catheter assembly can be combined with a stent to form a stenosis treatment device. More specifically, the stent may be arranged around the globe to couple the stent with a stenosis. It is desirable to have an apparatus and method for the average inflation of a balloon of expansion to finally expand the stent. Preferably, the appropriate average inflation and the location of the balloon of dilation in the region with stenosis forms a "dog bone" configuration. The "dog bone" shape occurs as the stenosis uniformly compresses the central portion of the dilated balloon and / or stent. This balloon inflation dynamics may limit the migration of the stent across the globe and thus minimize any misplaced deployment of the stent. Therefore, it is desirable to provide consistent inflation of the balloon of expansion so that the balloon expands uniformly and radially from a central point, thus avoiding uneven distortions in the balloon of expansion as it is inflated. In another preferred embodiment, the first marker and the second marker are disposed within the support volume. In addition, at least one of the first marker and the second marker are radio opaque and / or radiographic. Moreover, the outer surface of the The catheter wall defines a first diameter outside the support volume and a second diameter within the support volume. Preferably, the second diameter is smaller than the first diameter and the catheter includes a tapered portion between the first and second diameters. Another preferred embodiment according to the present invention provides a fluid delivery device. The fluid delivery device includes an elongate member having a proximal end and a distal end defining a first lumen and a second lumen spaced along a longitudinal axis. The first lumen of preference is configured to carry fluid, and the member preferably has an opening disposed between the proximal and distal ends in fluid communication with the lumen. The delivery device further preferably includes a first radio-opaque and / or radiographic marker and a second radio-opaque and / or radiographic marker. The first marker and the second marker preferably are arranged along the longitudinal axis and spaced apart from one another in order to be substantially equidistant from the opening. Another preferred embodiment according to the present invention provides a method for coupling a stenosis with an inflatable member having a first end and a second end wherein the inflatable member has disposed therein at least a portion of a tubular member having a first radio-opaque and / or radiographic marker and a second radio-opaque and / or radiographic marker separated along a longitudinal axis of the tubular member. The method preferably includes locating the first and second markers equidistantly around a portion of the stenosis so that the inflatable member is substantially centered along the length of the portion of the stenosis. The method further preferably includes: flowing a fluid in a channel of the tubular member along the longitudinal axis and introducing a sufficient amount of the fluid towards the inflatable member through an opening of the tubular member to expand the inflatable member substantially and radially and coupling the stenosis. Another embodiment further includes arranging a stent around the inflatable member so that the introduction of a sufficient amount of fluid into the inflatable member further engages the stent with the stenosis. Another preferred embodiment provides a method for dilating a stenosis wherein the method can be accomplished by locating a first marker of a catheter assembly on one side of a portion of a stenosis and locating a second marker on the opposite side of the portion so that The first and second markers are generally equidistant from the portion of the stenosis. The method further includes arranging a fluid filling opening of an inflatable member generally equidistant between the first and second markers, and expanding the inflatable member through the fluid filler opening substantially equal, longitudinally and radially around the central region. to attach and apply a Ease of expansion to the portion BRIEF DESCRIPTION OF THE DRAWINGS The accompanying drawings, which are incorporated herein and constitute a part of this specification, illustrate a preferred embodiment of the invention, and, together with the general description given above and the detailed description given below, serve to explain the aspects of the invention. Figure 1 is an illustrative perspective view of one embodiment of a balloon catheter assembly. Figure 1A is an isometric view of the proximal end of the assembly of Figure 1. Figure 1B is a geometric plan view of the assembly of Figure 1. Figure 2 is a detailed portion of the distal end of the assembly of Figure 1. Figure 2A is a detailed portion of the assembly of Figure 2. Figure 3 is a cross-sectional detail of the assembly of Figure 2. Figure 3A is a perspective view of a portion of the assembly of Figure 2. Figure 4 is an illustrative example of the assembly of Figure 1 used in a stenosis treatment procedure.

Modes for Carrying Out the Invention Figure 1 shows a preferred embodiment of a catheter assembly 10 for coupling a stenosis. More specifically, the catheter assembly 10 can be configured for angioplasty procedures wherein an inflatable member or balloon 12 is inserted into a blood vessel for coupling with a diseased portion of the blood vessel such as, for example, a stenosis or for coupling with an implantable prosthesis such as, for example, a stent or stent-graft. The catheter assembly 10 can also be configured to introduce an implant or stent (not shown) into the blood vessel to treat the stenosis. The stent may be disposed around the balloon 12 and the catheter assembly 10 may deliver and place the stent in engagement with the stenosis for implantation. Alternatively, the stent may be delivered to the stenosis independently of the catheter assembly 10. The catheter assembly 10 subsequently engages the stent at the site of the stenosis and inflates the balloon 12 to expand the stent for engagement with the stenosis. In general, the catheter assembly 10 includes a catheter 20 having a proximal portion 24 and a distal portion 22. The catheter 20 is preferably an elongate tubular member having a wall 21 forming an outer surface 23 and an inner surface 25 ( not shown) defining a longitudinal axis Ill-lll. The catheter 20 is preferably formed through extrusion of a thermoplastic material such as, for example, PEBAX thermoplastic material 7300® with a gel content of 9 percent or less composed of 10 percent Bismuth Subcarbonate. Preferably, arranged in the proximal portion 24 is a connector 26 having a first port 28 for the introduction of a guide wire into the catheter 20 and a second port 30 for the introduction of fluid. Arranged in the distal portion 22 of the catheter 20 is the balloon 12. The balloon 12 is preferably disposed about the distal portion 22 of the catheter 20 to locate an opening 36 in the catheter 20 within the support volume 18 of the catheter 20. balloon 12. Fluid is exchanged between balloon 12 and catheter 20 through opening 36 to inflate and deflate balloon 12. To assist an operator in locating balloon 12 along a stenosis or other target region, the catheter 20 may include first and second radiographic and / or radiopaque preferably markers, 38, 40, along the distal portion 22 within the support volume 18 of the balloon 12. The balloon 12 of the catheter assembly 10 of Preference has a first end 14, a second end 16 for defining the support volume 18 between them. The first and second ends 14, 16 can be disposed around the catheter 20. Preferably, the first end 14 and the second end 16 of the balloon 12 are sealed around the catheter 20 in order to enclose a distal portion 22 of the catheter 20 within the support volume 18 in a fluid-tight manner. For example, the first and second ends 14, 16 can be thermally bonded to the surface 23 of catheter 20 to form a fluid-tight seal. Alternative joining techniques can also be used to seal ends 14 and 16 to catheter 20 such as, for example, laser or adhesive bonding techniques. In addition, the balloon 12 may be coupled to the catheter 20 in any other form to enclose the distal portion 22 of the catheter 20 within the support volume 18 in a fluid-tight manner. The balloon 12 is preferably constructed of a nylon material, such as Nylon 12 or Nylon 11, or alternatively of other suitable thermoplastic polymers such as, for example, polyether block amide (PEBA), polyethylene, polyethylene terephthalate ( PET). In addition, the balloon can be a balloon of mixed material formed from a combination of Nylon and other polymers or a combination of high molecular weight polyethylene alone or with PET. Preferably, the balloon 12 defines a sufficient resistance in an inflated state in order to dilate or expand a stent or blood vessel. Another technique for forming the balloon 12 includes blow molding a Nylon or PET tube under heat in a mold to form the desired configuration, for example, a circular cylindrical body with two tapered tapered ends. The balloon 12 formed can be disposed on and thermally attached to the catheter 20. The U.S. No. 5,755,690 discloses a method for forming a high-strength multilayer balloon for a dilatation catheter wherein a parison (hollow balloon that is formed by blowing glass) of semi-crystalline orient polymer such as, for example, PET, is disposed within a mold with one end of the parison sealed and the other end secured to a source of fluid such as, for example, a gas. The parison is axially extracted and radially expanded within the mold to form an expanded balloon. The expanded balloon can then be exposed to a heat passage to increase the crystallinity in the balloon for dimensional stability. The balloon can then be removed from the mold and disposed around the catheter and thermally attached thereto. Alternatively, for the thermal bonding of the balloon 12, an adhesive may be employed to attach the balloon 12 to the catheter 20. The distal portion 22 and the proximal portion 24 of the catheter 20 are preferably formed as a unitary construction joined together through a transition section 46. Alternatively, the distal portion 22 and the proximal portion 24 may be distinct elements mechanically joined together through the transition 46. Preferably, the outer diameter of the proximal portion 24 is greater than the external diameter of the portion distal 22 of the catheter 20. The transition section 46 is preferably tapered from the proximal portion 24 to the distal portion 22. Alternatively, the transition section 46 may have a constant diameter to join the proximal portion 24 to the distal portion 22, thus forming a transition passage from the proximal portion 24 to the distal portion 22. The connector 26 disposed at the end The next 24 of the catheter 20 can be coupled to the catheter 20 through any technique suitable such as, for example, interference fit, threaded connection or pressure adjustment. The connector 26 is preferably disposed near the balloon 12. The connector 26 is configured to introduce a fluid, guide wire or any other instrument into the catheter 20. Specifically, the connector 26 includes a first port 28 configured to receive a guide wire ( not shown) that will be inserted along the vein or artery of the patient. The catheter assembly 10 can be disposed about the guidewire so that an operator can guide the assembly 10 along the cord to locate the assembly at a desired location relative to the stenosis within the vein or artery. More specifically and preferably, the balloon 12 can generally be centered through the lesion with stenosis. The first port 28 is preferably aligned parallel to or coaxial with the longitudinal axis 111-1 of the catheter 20. The connector 26 may further include a second port 30 configured to be connected to a fluid source (not shown). The fluid source may be, for example, a syringe or other pump / vacuum device for supplying a fluid. The fluid is preferably a liquid and may be, for example, a dye, a saline or any other contrast fluid to inflate the balloon 12. In Figure 1A another embodiment of the connector 26 is shown. The second port 30 may be configured to receive a syringe as a source of fluid for injecting and withdrawing fluid through the assembly 10. The second port 30 of Figure 1 preferably is in fluid communication with the first port 28 within the connector 26, however, the connector 26 can be configured to isolate the fluids from the second port 30 with the first port 28. The port 30 can form an incident angle with the catheter 20 Preferably, the port 30 forms an acute angle incident to the longitudinal axis III-III of the catheter 20 in the direction of fluid flow that moves distally away from an operator. During a procedure, the fluid is preferably introduced into the second port 30 and further into the catheter 20. The fluid is discharged from an opening 36 in the distal portion 22 of the catheter 20 and into the support volume 18 to expand the balloon 12. Preferably, the fluid is introduced into the balloon 12 to expand the balloon radially of the opening 36, along and around the longitudinal axis III-III. The port 30 can also be used to withdraw fluid from and deflate the balloon 12. Fluid can be withdrawn from balloon 12 towards catheter 20 preferably through opening 36 and returned to the fluid source through connector 26 and the port 30. Figure 1 and Figure 1B show balloon 12 in an inflated stateFigure 1B provides particular geometrical relationships of the assembly 10. In the inflated state, the balloon 12 is shown as a substantially tubular or cylindrical member along the longitudinal axis 111-1. In a plane perpendicular to the longitudinal axis III-III, the balloon 12 defines a cross section that is preferably circular, however, other cross sections such as, for example, oval, multiple lobes or other are possible. polygons The width w (preferably the diameter) of the balloon 12, as seen in Figure 1B, may vary from about 1 millimeter to about 40 millimeters, preferably ranging from about 1 millimeter to about 26 millimeters and still most preferably varying from about 3 mm to approximately 20 mm, and the length / of the balloon 12 can vary from approximately 10 mm to approximately 120 mm. Each end of the balloon 12 is preferably conical to thereby define a cone angle a relative to a line parallel to the longitudinal axis 111-111. The cone angle may vary from about five degrees (5o) to about thirty degrees (30). depending on the length / of the balloon. The dimensions A, B and C of the catheter 20 may vary along with the width w and the length / of the balloon 12. More specifically, the dimension A preferably measured from the first radiopaque and / or radiographic marker 38 to the second radiopaque marker and / or radiographic 40 can be of any suitable length and preferably of any one of approximately 10 millimeters, 15 millimeters, 20 millimeters, 30 millimeters, 40 millimeters, 60 millimeters, 80 millimeters, 100 millimeters, to approximately 120 millimeters in length. The dimension B, measured from the transition section 46 to the connector 26 may preferably be of any suitable length and preferably, any of about 40 centimeters, 75 centimeters, 115 centimeters, 130 centimeters, to about 140 centimeters in length. The measured dimension C of the section of transition 46 to second marker 40 preferably can be any of about 10 millimeters, 15 millimeters, to about 20 millimeters in length. Referring again to Figure 1, the catheter assembly 10 may also include a deflator 32 which is preferably a slide member 32 disposed about the outer surface 23 of the catheter 20. The slide member 32 may slide along the catheter 20 between the distal and proximal portions 22, 24. The sliding member 32 can be configured to help deflate the balloon member 18 by passing over the balloon 12 to displace any fluid and / or air in the support volume 18. The slidable member 32 can include a central channel through which the balloon 12 and the catheter 20 can pass. The body of the slidable member 32 preferably has a substantially reel shape to provide a low profile and facilitate operator handling; however, other geometries that allow manual manipulation are possible, however. The catheter assembly 10 may also include a removable cover 34. The cover 34 may be coupled and uncoupled from the balloon 12 and the distal portion 22 of the catheter to protect the balloon 12 from damage when not in use. Figure 2 shows an enlarged view of the distal portion 22 of the catheter 20 sealed inside the balloon 12. The distal portion 22 of the catheter 20 further includes the opening 36. Preferably, the first and second ends 14, 16 of the balloon 12 are secured around of catheter 20 in order to remain equidistant separated from the opening 36 and thus placing the opening 36 in a substantially central location within the support volume 18 of the balloon 12. Any fluid introduced into the catheter 20 can be discharged through the opening 36 to inflate the balloon 12 to starting from an initial deflated state or volume (not shown) to a substantially inflated state or volume (as shown in Figure 2). In Figure 2A a detail is shown in plan view of the opening 36. The opening 36 is preferably rectangular and elongated in the direction of the longitudinal axis III-III in order to supply and evacuate a sufficient volume of fluid to inflate and deflate. respectively the balloon 12. The opening 36 may further include a cha or transition 37 from inside the catheter 20 to the external surface 23, and the edges of the opening 36 along the outer surface 23 are preferably rounded to help obtain the desired flow characteristics. For example, when the opening 36 is rectangular, the dimensions of the opening 36 can measure approximately 0.2 centimeters in length and approximately 0.02 centimeters in width. In general, the opening 36 can have any dimensioned geometry and transition characteristics such as, for example, substantially circular, oval or polygonal, provided that the desired flow characteristics are obtained for rapid inflation and disinflation of the balloon 12. Preferably, the opening 36 is dimensioned and configured in a ways that provides the inflation of disinflation of balloon 12 over a period of time that minimizes the time during which the blood vessel can be occluded by balloon 12. As described above, the dimensions of catheter 20 may vary with the dimensions of balloon 12. consequently, the dimensions of the opening 36 and the balloon 12 may be such that they define a relationship over various configurations of the catheter 20. Specifically, in a preferred embodiment, the area of the opening 36 and the support volume 18 fully expanded of the balloon 12 they can define an area-to-volume ratio. This ratio can be constant through various configurations of the catheter 20. Alternatively, the ratio of the area of the opening 36 to the fully expanded support volume 18 of the balloon 12 can be varied through various configurations of the catheter 20. The centralized location of the opening 36 shown in the Figure 2 in relation to the balloon 12 can provide a distribution of fluid within the balloon 12 to facilitate uniform and radial expansion of the balloon 12 from the deflated state to the inflated state. More specifically, the fluid discharged from the substantially central point within the support volume 18 of the balloon 12 couples the inner surfaces of the balloon equally radially and uniformly along the longitudinal axis direction III-III. In this way, uneven concentrations of fluid or waves that can deform the shape of balloon 12 are minimized or otherwise avoided. This can ensure that a target area (for example, stenosis or stent) is fully and uniformly coupled by balloon 12 or stent to produce the preferred "dog bone" shape of balloon 12. In the case where balloon 12 is being used to implant a stent, the expansion The centralized balloon 12 can ensure that the stent is substantially and uniformly expanded along its length. The distal portion 22 of the catheter 20 further includes the first marker 38 and the second marker 40 disposed on the outer surface 23 of the catheter 20. Preferably, the markers 38, 40 are made of a radiopaque and / or radiographic material such as, for example, Gold 18 Karat, platinum, tantalum, BaS0, iridium, to make the catheter 20 or at least the distal portion 22 visible under fluoroscopic observation. The markers 38, 40 can be used by an operator to guide the catheter assembly 10 under fluoroscopic observation to a desired location within the blood vessel. The first and second radio-opaque and / or radiographic markers 38, 40 are preferably separated and located along the longitudinal axis III-III so that the markers are equidistantly spaced from the aperture 36. Most preferably, the markers 38, 40 are disposed within the support volume 18. Since the first and second ends 14, 16 of the balloon 12 are also preferably centered around the opening 36, the first and second markers 38, 40 can facilitate centering of the balloon 12 with respect to the target area. In particular, a doctor can use radio-opaque markers 38, 40 under observation fluoroscopic to center the opening 36 along the length of the target area, such as a lesion with stenosis, and due to the fixed ratio of the ends 14, 16 of the balloon to the opening 36, the balloon in this manner is preferably centered with respect to the target region to properly couple the length of the target region. A cross-sectional view of a portion of the distal portion 22 of the catheter 20 is shown in Figure 3. The inner surface 25 of the wall 21 forming the catheter 20 can further define a first lumen or lumen 42, preferably parallel to the longitudinal axis lll-lll. The lumen 42 can extend from the distal portion 22 to the proximal portion 24 of the catheter 20 for communication with the second port 30 of the connector 26 in order to exchange a fluid, preferably a liquid between the balloon 12 and the fluid source for inflation / disinflation of the balloon 12. The internal diameter of the lumen 42 is dimensioned to provide a sufficient flow of fluid given the supply pressures from the fluid source such as, for example, a syringe. The internal diameter of the first lumen 42 can remain constant over the entire length of the catheter 20 or alternatively, the internal diameter of the first lumen 22 can change over the length of the catheter 20. The lumen 42 is preferably deviated from the longitudinal axis of the central line III. -lll of the catheter 20. To facilitate the exchange of fluid between the balloon 12 and the catheter 20, the lumen 42 is in fluid communication with the support volume 18 through the opening 36 shown in Figures 2 and 3. More specifically, the opening 36 is positioned relative to the lumen 42 in order to define a fluid path having an angle incident to the longitudinal axis 111- lll. The fluid transported along the lumen 42 can be discharged from the opening 36 towards the support volume 18 to expand the balloon 12. Preferably, the flow path is substantially orthogonal to the longitudinal axis III-III to radially disperse the fluid from a substantially central portion of the support volume 18. Alternatively, the opening 36 may be positioned and configured to define a fluid path having an acute angle with the longitudinal axis 111-1 provided the fluid path can be dispersed from a substantially substantial portion of the fluid. of the support volume 18. An end view of the catheter 20 is shown in Figure 3A.

Preferably, the cross section of the first lumen 42 is substantially rectangular, and most preferably, is increasingly so as to convey an adequate flow of fluid to and of the support volume 18. The first lumen 42 can be sized and configured to fit properly within the total size restrictions of catheter 20 such as, for example, the external diameter of catheter 20 and the cross-sectional demands of catheter 20 to accommodate any additional lumen. The cross-sectional area of the lumen 42 can define other geometries such as substantially circular, for example, provided that the lumen 42 is sized to transport the proper fluid flow. In a preferred embodiment, the lumen 42 is sealed at the distal end to provide a sufficient discharge pressure at the opening 36 to promote uniform radial expansion of the balloon 12. In general, the balloon 12 is rated for an operating pressure varying from about 4 atmospheres (atm.) to about 8 atmospheres (atm.) and most preferably about 8 atm., which corresponds to an operational supply pressure of about 8.7875. Depending on the size of the balloon 12, the balloon 12 can also be configured for rated burst pressures that vary from about 8 atm. At approximately 16 atm. Alternatively, the lumen 42 can have multiple discharge openings provided that sufficient discharge pressure is provided in the opening 36. The fluid in the support volume 18 can be withdrawn through the opening 36 and made to the lumen 42 to deflate the balloon 12. In addition to facilitating the radial expansion of balloon 12, the central placement of opening 36 relative to support volume 18 can maximize the time during which opening 36 remains patent as the fluid is drawn through. of the opening 36 and the balloon 12 collapses around the distal end 22 of the catheter 20 and finally over the opening 36. Accordingly, the placement of the opening 36 can control the efficiency of the disinflation of the balloon 12. The efficiency of the disinflation of the globe can define the time required to deflating the balloon thus defining the period in which an inflated balloon 12 blocks or restricts the flow of blood through the blood vessel. Generally, it is desired that the period of time during which the expansion of the balloon 12 blocks the flow of blood through the blood vessel is reduced to the pussycat. The catheter 2 shown in Figure 3 preferably includes a second lumen or lumen 44 defined differently by the wall 21 extending parallel to the longitudinal axis 111-lll and the first lumen 42. The second lumen 44 is sized and configured to receive a cable guide on which the catheter assembly 10 can move. The second lumen 44 separates the guide wire from the fluid flow in the lumen 42, thus eliminating interference with the fluid flow or pressure characteristics by the presence of the guide wire. Preferably, the second lumen 44 extends from the distal end towards the proximal end of the catheter 20 for communication with the first port 28 of the connector 26. The second lumen 44 is preferably sized and configured to receive the guide wire from port 28. The cable The guide can be a conventional surgical guide wire such as, for example, stainless steel type 302 or 304 having an outer diameter of about 0.25 millimeters. The first and second lumen 42, 44 can alternatively be defined by different tube members within a larger individual catheter tube (not shown). The internal diameter of the second lumen 44 can remain constant over the entire length of the catheter 20 or alternatively, the The internal diameter of the second lumen 44 can change over the length of the catheter 20 to accommodate demands for space in the total transverse area of the catheter 20. Preferably, the total cross-sectional area of the catheter 20 remains constant over the various configurations of the catheter 20 discussed above. Alternatively, the entire cross-sectional area of the catheter 20 can vary proportionally with any one or more of the dimensions defining the catheter 20 such as, for example, the total length of the catheter or the lengths A, B or C described above. In Figure 3A, the cross section of the substantially circular lumen 44 is shown to provide the guidewire with a substantially smooth wall through which it passes. Alternatively, other geometries such as rectangular, oval or any other configuration are possible as long as the lumen 44 is dimensioned to allow passage of the guide wire. The second lumen 44 is preferably deviated from the centerline longitudinal axis MI-MI of the catheter 20 to adapt the dimension and configuration of the first lumen 42 for delivery of the proper operating pressure to inflate the balloon 12. The catheter can be dimensioned to adapt an additional lumen to provide channels for the insertion of other fluids or devices such as, for example, a third lumen for carrying a temperature probe (not shown). In Figure 4 there is shown an illustrative representation of a stent delivery procedure wherein the modality The preferred embodiment of the catheter assembly 10 described above is to locate and position a stent 50 along a stenosis 60 for expansion of the stenosed lesion and blood vessel 62. The catheter assembly 10 is preferably arranged around a guide wire 52, and an operator using assembly 10 under luchoscopic observation can align balloon 10 and stent 50 with stenosis and furthermore identify a portion of stenosis 60 to which a direct expansion force can be applied using the balloon. of the assembly 10. Preferably, the identified portion is the central portion of the stenosis 60. Accordingly, the operator slides the catheter assembly 10 along the guide wire 52 to align the radiopaque markers 38, 40 equidistantly around the central portion of the stenosis 60 and thus align a substantially central region of the balloon 12 with the central portion of the stenosis. A contrast fluid can be piped along the catheter 20 and introduced into the support volume 18 of the balloon 12 through the opening 36 to fully dilate the balloon 12 and the stent 50 as shown. The preferably fixed centralized relationship of the opening 36 to the markers 38, 40 aligns the opening 36 with the identified portion of the stenosis to be expanded, and with the opening 36 preferably centrally located in the support volume 18, the balloon 12 and the stent 50 are preferably uniformly and radially expanded around the central region of the balloon 12 in engagement with the stenosis to apply forces of expansion to at least the defined portion. The various configurations of the catheter assembly 10 described herein provide numerous advantages for the performance of angioplasty and stent delivery procedure. The catheter 20 preferably includes two separate lumens to separately carry a guide wire and an inflation fluid. The separately dedicated lumen can facilitate the supply of the inflation fluid at the proper operating pressure to expand the inflation balloon 12 by minimizing or eliminating the interference of the guide wire with the fluid flow or supply pressure. The opening 36 of the catheter 20 is preferably centrally disposed within the support volume 18 to facilitate the supply of central fluid and located within the support volume 18 to promote a uniform radial expansion of the balloon 12. The uniform radial expansion of the balloon 12 can ensure proper coupling between the balloon 12 and the stent or stent graft in order to radially expand the stent device and prevent migration of the stent device along the balloon 12. In addition, the centralized location of the opening 36 relative to the support volume 18 can increase the efficiency of balloon disinflation by maximizing the patency of the opening 36 to withdraw fluid from the balloon 12 while minimizing the time the balloon remains in the expanded state to occlude the blood vessel that is being treated. In addition, the markers 38, 40 are preferably located within the support volume 18 and in relation to the opening 36 of the catheter 20 to provide the visual indicators needed to centralize the balloon 12 relative to the target area or region. Radio-opaque and / or radiographic markers 38, 40 help to properly locate the balloon and / or stent or stent graft relative to the center of a target region or center. Although the present invention has been described with reference to certain embodiments, numerous modifications, alterations and changes to the described embodiments are possible without departing from the scope and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the embodiments described, but rather have the full scope defined by the language of the following claims, and their equivalents. As used here, the singular form of "a", "one", "one" and "the", "the" include plural references unless it is specifically defined as only one.

Claims (27)

1. - A catheter assembly for coupling a stenosis, the assembly comprising: a catheter including a wall having a proximal end and a distal end disposed along a longitudinal axis, the wall having an inner surface and an outer surface, the surface interior defining a first lumen and a second lumen separated and disposed about the longitudinal axis, the wall defining an opening extending between the inner surface and the outer surface, the opening being in communication with the first lumen to define a flow path having an angle incident to the longitudinal axis; a first marker arranged around the outer surface along the longitudinal axis; and a second marker disposed about the outer surface along the longitudinal axis, the first and second markers being spaced from one another along the longitudinal axis to be equidistant from the aperture; and a balloon having a first end and a second end defining a support volume between them, the first end and the second end being sealed around the outer surface, the opening is disposed within the support volume for placing the first lumen in sealed fluid communication with support volume, first and second ends being substantially and equidistantly spaced around the opening along the longitudinal axis.

2. The catheter assembly according to claim 1, wherein the support volume defines a first volume and a second volume greater than the first volume, the opening being configured to alter the support volume between the first and second volumes. substantially and radially around the opening.

3. The catheter assembly according to claim 2, wherein the balloon has an operating pressure of about 8 atm., To define a fluid supply pressure in the opening to alter the support volume between the first and second. volumes.

4. - The catheter assembly according to claim 1, wherein the balloon has a width ranging from about 1 millimeter to about 40 millimeters.

5. The catheter assembly according to any of the preceding claims, wherein the The balloon has a width that varies from approximately 1 millimeter to approximately 26 millimeters.

6. - The catheter assembly according to any of the preceding claims, wherein the balloon has a width ranging from about 3 millimeters to about 20 millimeters.

7. The catheter assembly according to any of the previous claims, wherein the balloon has a length ranging from about 10 millimeters to about 120 millimeters.

8 - The catheter assembly according to any of the preceding claims, further comprising a connector arranged around the outer surface near the balloon, the connector having a first port and a second port in communication with the second lumen, the first port being in fluid communication with the first and second lumen.

9 - The catheter assembly according to the claim 8, wherein the first port defines an incident angle to the first lumen and the second port is substantially coaxial with the second lumen.

10. The catheter assembly according to any of the preceding claims, wherein the first marker and the second marker are disposed within the support volume.

11 - The catheter assembly according to any of the preceding claims, wherein at least one of the first marker and the second marker comprises at least one of a radiopaque and radiographic material.

12. The catheter assembly according to any of the preceding claims, wherein the outer surface of the wall defines a first diameter outside the support volume, the outer surface defining a second diameter within the support volume, the second diameter being smaller than the first diameter, the outer surface including a tapered portion between the first and second diameter.

13. The catheter assembly according to any of the preceding claims, further comprising a deflator disposed around the outer surface, the deflator having a first wax position of the balloon and a second position away from the balloon, the deflator being configured for move along the longitudinal axis from the first position to the second position in order to alter the support volume.

14 - The catheter assembly according to any of the preceding claims, further comprising a cap coupled to the catheter so that the balloon is disposed within the cap.

15. The catheter assembly according to any of the preceding claims, further comprising a stent arranged around the balloon, the balloon being configured to couple the stent with a stenosis.

16 - A fluid delivery device, comprising: an elongate member having a proximal end and a distal end defining a first lumen and a second lumen separated from the first lumen along a longitudinal axis, the first lumen being configured to transport a fluid, the member having an opening disposed between the proximal and distal ends, the opening being in fluid communication with the first lumen; and a first marker and a second marker, the first marker J J and the second marker being arranged around the member and separated from one another to be substantially equidistant from the opening.

17 - The fluid supply device according to claim 16, wherein the first lumen defines a substantially cross-sectional area with increasing shape, perpendicular to the longitudinal axis.

18. The fluid delivery device according to claim 16, wherein the first lumen defines a substantially rectangular transverse area, perpendicular to the longitudinal axis.

19 - The fluid supply device according to any of claims 16-18, wherein the opening comprises a substantially rectangular opening.

20. The fluid delivery device according to any of claims 16-19, wherein the first marker and the second marker are radiopaque and radiographic material.

21. - The fluid supply device according to any of claims 16-20, wherein the second lumen is arranged around the guide wire.

22. - The fluid supply device according to any of claims 16-21, further comprising a connector arranged around the outside, the connector having a first port in communication with the first lumen and a second port in communication with the second lumen.

23. - The fluid delivery device according to any of claims 16-22, wherein the elongated member includes a proximal portion and a distal portion, the proximal portion having a first diameter and a distal portion having a second diameter, the second diameter being smaller than the first.

24. - The fluid delivery device according to claim 23, wherein the proximal portion tapers below the distal portion.

25. - A method for expanding a stenosis, the method comprising: locating a first marker of a catheter assembly on one side of a portion of a stenosis and locating a second marker on the opposite side of the portion so that the first and second markers are equidistant from the portion of the stenosis in order to align a substantially central region of an inflatable member with the portion; and introducing a sufficient amount of the fluid in the inflatable member to expand the substantial inflatable member, equal and radially around the central region to engage and apply an expansion force to the portion.

26 - The method according to claim 25, wherein the introduction comprises interposing a stent between the inflatable member and the portion.

27. - A method for dilating a stenosis, the method comprising: locating a first marker of a catheter assembly on one side of a portion of a stenosis and locating a second member on the opposite side of the portion so that the first and second markers they are generally equidistantly from the portion of the stenosis; arranging a fluid filling opening of an inflatable member generally equidistant between the first and second markers; and expanding the inflatable member through the fluid fill opening substantially, equal, longitudinally and radially around the central region to engage and apply an expansion force to the portion.