Source: https://patents.google.com/patent/EP1663340A2/en
Timestamp: 2019-04-20 04:41:09+00:00

Document:
Pursuant to 35 U.S.C. § 1.19(e), this application claims the benefit of priority of U.S. Provisional Application No. 60/488,006 filed July 18, 2003; U.S. Provisional Application No. 60/518,870 filed November 12, 2003; U.S. Provisional Application No. 60/547,778 filed February 27, 2004; and U.S. Provisional Application No. 60/548,868 filed March 2, 2004. The complete disclosures of the above-referenced applications are incorporated herein by reference.
Administering PTCA and/or implanting a stent at a bifurcation in a body lumen poses further challenges for the effective treatment of stenoses in the lumen. For example, dilating a main vessel at a bifurcation may cause narrowing of the adjacent branch vessel. In response to such a challenge, attempts to simultaneously dilate both branches of the bifurcated vessel have been pursued. These attempts include deploying more than one balloon, more than one prosthesis, a bifurcated prosthesis, or some combination of the foregoing. However, simultaneously deploying multiple and/or bifurcated balloons with or without endoluminal prostheses, hereinafter individually and collectively referred to as a bifurcated assembly, requires accurate placement of the assembly. Deploying multiple stents requires positioning a main body within the main vessel adjacent the bifurcation, and then attempting to position another stent separately into the branch vessel of the body lumen. Alternatives to that include deploying a dedicated bifurcated stent including a tubular body or trunk and two tubular legs extending from the trunk. Examples of bifurcated stents are shown in U.S. Patent No. 5,723,004 to Dereume et al., U.S. Patent No. 4,994,071 to MacGregor, and U.S. Patent No. 5,755,734 to Richter et al.
Additional bifurcation stent delivery systems that provide improved reliable treatment at bifurcations are disclosed, for example, in U.S. Patent No. 6,325,826 to Vardi et al. and U.S. Patent No. 6,210,429 to Vardi et al. The contents of these aforementioned patents are incorporated herein by reference.
FIG. 10 is a perspective view of a balloon configured according to yet another alternative embodiment of the present invention. FIG. 11 is a perspective view of a balloon configured according to another embodiment of the present invention.
FIG. 13 is a perspective view of a portion of a balloon constructed according to the principles of the embodiment of FIG. 1 1.
The present invention relates to balloon catheters such as balloon angioplasty catheters to treat occlusions in blood vessels. The balloon catheters can be used alone or with a stent, prosthesis or graft. Such a stent delivery system can be used for placement of a stent in a body lumen, particularly at vessel bifurcations. A preferred stent to be delivered is generally configured to at least partially cover a portion of a branch vessel as well as a main vessel. In general, a wide variety of stents and deployment methods may be used with the stent delivery system embodiments of the present invention and the present invention should be understood to not be limited to any particular stent design or configuration. Examples of the types of stents that may be used with the delivery systems of the present invention are disclosed, for example, in U.S. Patent No. 6,210,429 to Vardi et al., U.S. Patent No. 6,325,826 to Vardi et al., and co-pending U.S. Patent Application No. 10/644,550, entitled "Stent With a Protruding Branch Portion For Bifurcated Vessels," the entire contents of which are incorporated herein by reference. In general, the aforementioned stent includes a branch portion located at some point along the length of the stent that is configured to be extendible into a branch vessel in a vessel bifurcation. Once the stent is in position in the main vessel and the branch portion is aligned with the side branch vessel the stent can be expanded and the delivery system is particularly adapted to expand the stent branch portion into the side branch vessel. The stent, including the branch portion, may be expanded with a single expansion or multiple expansions.
An illustrative view of one embodiment of a stent delivery system 10 constructed in accordance with the present invention is shown in FIG. 1. Stent delivery system 10 generally comprises an elongate main catheter shaft 12 extending from a proximal end 14 to a distal end 16. As best seen in FIG. 2, distal end 16 has a bifurcated tip structure with two branch portions, a main vessel branch portion 18 and a side branch sheath 20 that branch off of main catheter shaft 12. A bifurcated balloon 26 is attached to main vessel branch portion 18 adjacent the distal end 16 and comprises first and second branch portions 27, 30. First branch portion 27 of balloon 26 comprises an elongate inflatable portion 28. Second branch portion 30 of balloon 26 comprises a second inflatable portion or auxiliary inflatable portion 32. Second branch portion 30 includes an inflation lumen that branches off from first branch portion 27 proximally from the balloon 26 and extends substantially adjacent elongate inflatable portion 28. The distal end of second branch portion 30 is attached to first branch portion 27 at a location distally from the balloon 26. In one preferred embodiment, the distal end of branch portion 30 is fixedly attached distally of balloon 26 in order to prevent at least the second inflatable portion 32 from moving around the first branch portion 27, although in alternate embodiments it may be removably attached. In a preferred embodiment, first inflatable portion 28 is generally cylindrical and extends coaxially along main vessel branch portion 18. Second inflatable portion 32 may have a shape and size adapted to extend into the branch vessel as shown and described herein. For example, portion 32 may have a generally offset configuration and may be positioned adjacent or in abutting relation with respect to elongate inflatable portion 28.
In the embodiment depicted in FIGS. 1-2, an optional side sheath 20 is illustrated which does not include an inflatable balloon. Although in alternate embodiments side sheath 20 could include an inflatable portion, as described for example in co-pending U.S. Patent Application No. 10/644,550 entitled "Stent With a Protruding Branch Portion For Bifurcated Vessels". Side sheath 20 is exterior to and distinct from inflation lumen 34 and thus is also not in fluid communication with the interior of balloon 26 as shown. As shown in the embodiment of FIGS. 1-2, side sheath 20 preferably extends distally of balloon 26, and may include a proximal open end 37 at any point along the length of the stent delivery system and a distal open end 39. Side sheath 20 can be of the type as described in U.S. Patent No. 6,325,826 to Vardi, et al, for example, and in operation the side sheath 20 can extend through a branch access hole of the stent.
With reference to FIGS. 3-6, an exemplary manner of practicing the invention will now be discussed. Referring to FIGS. 3 and 5, the delivery system is shown in relation to an exemplary body lumen adjacent a blood vessel bifurcation 40 usually comprised of plaque and the delivery system 10 is shown without a stent mounted thereon (FIGS. 3 and 5). Figs. 4 and 6 show the stent delivery system 10 with a stent 50 mounted thereon. Bifurcation 40 includes a main vessel 42 and a branch vessel 44. Illustrative obstructions 46 located within bifurcation 40 may span or at least partially obstruct main vessel 42 and a proximal portion branch vessel 44. Generally, stent delivery system 10 may be threaded over a first main guidewire placed in the main vessel to guide the delivery system to the treatment site. More specifically, the proximal end of first guidewire 36 is threaded into the distal open end of the main guidewire lumen 22 and the delivery system is tracked to a position at or near bifurcation 40, as depicted in FIG. 3. Second guidewire 38 (FIG. 5) is then threaded into stent delivery system 10 from the proximal end of the delivery system. More specifically, second guidewire 38 is threaded into the open proximal end 37 of side sheath 20, and may extend therefrom through the open distal end 39 of side sheath 20, as depicted in FIG. 5. Alternatively, second guidewire 38 can be resting dormant on the inside of the side sheath, and when the system is proximal the bifurcation 40, it can be advanced out of side sheath 20 into side branch vessel 44. The systems in accordance with the principles of the invention may be used in over-the-wire or rapid exchange systems, which may include rapid exchange on either or both of the side sheath or main catheter. Rapid exchange is described in one exemplary embodiment in US2003/0181923 to Vardi et al., published September 25, 2003, the entire contents of which are incorporated herein by reference.
(opening) and expandable branch structure of the stent, as discussed in more detail with reference to FIG. 6. After inflatable portions 28 and 32 have been inflated as described above, balloon 26 is deflated by draining the inflation fluid via inflation lumen 34. This allows the inflatable portions 28 and 32 to collapse in preparation for withdrawal of the assembly from vessel 42.
Referring now to FIGS. 4 and 6, one preferred embodiment is shown with stent delivery system 10 and an exemplary stent 50 mounted on the exterior of distal end 16 of the stent delivery system. Stent 50 includes an extendible branch portion 52 configured to extend into a branch vessel as discussed in co-pending U.S. Application No. 10/644,550, entitled "Stent with Protruding Branch Portion for Bifurcated Vessels". The second inflatable portion 32 may be configured and positioned to deploy the outwardly expanding stent elements or branch portion 52 and may be positioned adjacent to the branch portion 52, or into a side branch access opening in the stent. As shown in FIG. 6, when first and second inflatable portions 28 and 32 are expanded, they simultaneously or sequentially, depending upon the configuration of the inflation lumen, cause the stent 50 to expand in the main vessel 42 and the branch portion 52 of stent 50 to be pushed or extended into the branch vessel 44. Upon inflation of the balloon 26, the second inflatable portion 32 expands and extends the branch portion 52 toward the branch vessel to open and support the entrance or ostium of the side branch artery. This would occur simultaneously when the balloons share a common inflation lumen but could be sequentially if separate inflation lumens are used. Although a bifurcated balloon is depicted, as shown, more than two inflatable portions or more than two balloons may be utilized with the present invention.
FIG. 8 illustrates an alternative auxiliary inflatable side portion construction 132. According to this embodiment, the central portion 133 of the auxiliary inflatable side portion 132 extends in a generally equidistant manner from the longitudinal axis A, and at an angle of up to about 90° relative to longitudinal axis A, but other angles are contemplated. As illustrated in FIG.8, the balloon 132 comprises a generally elliptical central portion 133, as well as a proximal shaft portion 141, and distal shaft 143 connected thereto. As with the previous embodiment, the various components of the balloon 132 may be sized as appropriate within appropriate dimensional ranges, as determined by those skilled in the art. The elliptical central section 133 of the balloon 132 is provided with major and minor diameters, Di and D2, respectively, as illustrated in FIG.7. According to non-limiting exemplary embodiments, the elliptical central section may be shaped such that the ratio D2/Dι is on the order of about 0.8. According to further exemplary non-limiting embodiments, the major diameter Dj is preferably on the order of about 3.65-3.85mm and can range from 1.5-6mm, while the minor diameter D2 is smaller than Di and is preferably on the order of about 2.9- 3.1mm.
FIG.9 illustrates yet a further embodiment of auxiliary inflatable side portion 232 of bifurcated balloon 26 constructed according to the principles of the present invention. According to this embodiment, the central portion 232 is offset relative to the longitudinal axis A and preferably extends toward and/or into the branch vessel 44. The central portion 232 may extend at an angle of up to about 90° relative to longitudinal axis A, but other angles are contemplated. As illustrated in FIG. 9, the auxiliary inflatable side portion 232 of balloon 26 comprises an offset central bulbous or generally spherical portion 233, with a proximal shaft portion 241 and distal shaft portion 243 connected thereto via a proximal transition section 241τ and distal transition 243χ, respectively. As with the previous embodiments, the various components of the auxiliary inflatable side portion 232 of balloon 26 can be sized as appropriate, and as readily determined by those skilled in the art. According to exemplary, non-limiting embodiments, the auxiliary inflatable side portion 232 of balloon 26 can be configured such that the central offset portion 233 is provided with a radius of curvature R which is on the order of about .50-3.0mm.
FIG. 10 illustrates yet another alternative embodiment for an auxiliary inflatable side portion 332 of bifurcated balloon member 26. According to this embodiment, the central portion 332 is offset relative to the longitudinal axis A and preferably extends toward and/or into the branch vessel 44 (not shown). The central portion 332 may extend at an angle of up to about 90° relative to longitudinal axis A, but other angles are contemplated. As shown in FIG. 10, the auxiliary inflatable side portion 332 is configured such that it comprises a generally offset elliptical and cylindrical central section 333, with proximal shaft portions 341 and distal shaft portions 343 connected thereto via proximal transition section 341τ and distal transition portion 343τ, respectively. The offset central section 333 is preferably configured such that it comprised a first diameter Di and second diameter D2 wherein Dj and D2 have different values (Dl ≠ D2). The dimensions of the various constituent components of the auxiliary inflatable side portion 332 can be determined by those skilled in the art. According to exemplary non-limiting embodiments, the auxiliary inflatable side portion 332 can be configured such that it is provided with first and second diameters such that the ratio D2/Dι is on the order of about 0.25-4.0mm. According to further, non-limiting examples, the auxiliary inflatable side portion 332 can be configured such that it is provided with a first diameter Di which has dimensions on the order of about 1.5-6.0mm and, preferably about 2.7-2.9mm, and a second diameter D2 which has dimensions on the order of about 1.5-6.0mm, and preferably about 2.1-2.3mm.
FIG. 11 illustrates yet another alternative embodiment of an auxiliary inflatable side portion 432 of bifurcated balloon 26. According to this embodiment, the central portion 432 is offset relative to the longitudinal axis A and preferably extends toward and/or into the branch vessel 44 (not shown). The central portion 432 may extend at an angle of up to about 90° relative to longitudinal axis A, but other angles are contemplated. The auxiliary inflatable side portion 432 is configured such that it comprises an offset generally cylindrical central section 433 having a proximal shaft portion 441 and a distal shaft portion 443 connected thereto via proximal transition shaft portion 441τ and distal transition portion 443τ, respectively. The various constituent components of the balloon 432 can be configured with relative dimensions which can be ascertained by those skilled in the art. According to exemplary, non- limiting examples, the balloon 432 can be configured such that it is provided with an offset generally cylindrical central section 433 having a diameter D which is on the order of about 1.5-6.0mm.
FIGS. 12-15 illustrate further alternative embodiments of the present invention which can be utilized in the treatment of branch arteries, including incorporation into stent- delivery systems of the type previously described. The balloons depicted in the embodiments of FIGS. 12-15 can be referred to as "herniated" balloon configurations that function in a manner similar to the embodiments described above. The herniated balloon configuration is characterized by having a generally cylindrical shape in an unexpanded configuration, and a generally cylindrical shape with a generally hemispherical appendage that inflates outwardly relative to the longitudinal axis of the balloon toward the branch artery in an expanded state or configuration. This protrusion can be referred to as a herniation, bulge, protrusion, or extension. The particular shape, size, and configuration of the balloon and the herniations illustrated herein are exemplary, and may be modified from that explicitly shown and described. The expandable herniation, bulge, protrusion, or extension can be expandable towards the entrance of side branch (e.g. - 44, FIG.3) over a suitable dimension, such as 1- 4mm.
The particular configuration and dimensions of the balloon catheter 526 can vary according to a number of factors. For purposes of illustration only, certain suitable, but non-limiting, dimensions of various components of the balloon catheter 526 will now be described. The balloon catheter 526 can be provided with a length dimension Li which is about 4-100mm. The balloon can be provided with an outside diameter ODi which is on the order of about 1-lOmm, and the herniation 532 can be provided with a radius of curvature Ri which is about 0.5-3mm.
533". Illustrative and non-limiting examples of suitable dimensions according to this embodiment include: an outside diameter OD3 (FIG. 15) of about 1-1 Omm; a length dimension L3 of about 4-100mm; a height dimensions H of the herniation 533" of about l-6mm; and a radius of curvature R3of the herniation 533" of about 0.5-3mm; and a wall thickness of the herniated balloon catheter portion 526" of about 0.01mm.
The balloon 526, 526', and/or 526" can be constructed of any suitable material such as those previously disclosed herein. In addition, the balloon 526, 526', and/or 526" can be constructed of a composite material. Suitable materials include a combination of elastomeric and semi to non-compliant materials such as: urethane; silicone; nylon; latex; (elastomeric) polyethylene hytrel pebax polyaryletherthketone; polyoxymethylene; polyamide; polyester thermoplastic polyetheretherkatone; and polypropylene (semi non-compliant). The balloon 526, 526', and/or 526" can be also be constructed by combining the above-disclosed materials with woven textile materials such as Kevlar, silk, cotton, wool, etc. This can be accomplished by winding or weaving a textile material onto a rod that has the shape of the desired herniated balloon. The polymer component of the composite is then extruded or dip- coated over the rod. This composite structure is then cured, heat set, or adhesively fused together. The rod is then removed and the remaining shape comprises the herniated balloon 526, 526', and/or 526".
The herniation 533, 533', and/or 533" can be provided by adding an appendage to a conventional balloon by using a molded collar or adhesively attaching an object to the surface of the balloon, or by using a mound of adhesive to create the herniation. The balloon 526, 526', and/or 526" can be constructed by molding three small balloons and attaching them in tandem. The central balloon comprising the desired shape of the herniation. These balloons would share a common inflation port. When the balloons are inflated, the center balloon expands in the desired manner to form the herniation.
1. An apparatus for treatment of a bifurcation of a body lumen, the bifurcation comprising a main vessel and a branch vessel, the apparatus comprising: a bifurcated balloon comprising a first branch portion and a second branch portion; the second branch portion comprising an inflatable portion adapted to extend toward the branch vessel, the bifurcated balloon further comprising a proximal shaft portion and a distal shaft portion connected to the inflatable portion of the second branch portion; wherein the first branch portion and the second branch portion each have a longitudinal axis, the longitudinal axis of the first branch portion is substantially parallel to the longitudinal axis of the second branch portion.
9. The apparatus of claim 8, wherein the inflatable portions are circumferential ly spaced about the first branch portion.
12. A system for treatment of a bifurcated body lumen, the system comprising: a catheter for insertion into said body lumen, the catheter having a bifurcated distal end comprising first and second branches; and a bifurcated balloon positioned on one of said first and second branches; the bifurcated balloon having a first balloon branch and a second balloon branch, the first balloon branch including a first inflatable portion and the second balloon branch including a second inflatable portion, and wherein the first inflatable portion has a generally cylindrical shape when inflated and the second inflatable portion has a generally offset bulbous shape when inflated.
13. The system of claim 12, further comprising: a stent mounted on the bifurcated balloon, the stent including a side branch access hole.
15. A method of treating a bifurcation of a body lumen, the bifurcation comprising a main vessel and a branch vessel, the method comprising: (i) introducing a bifurcated balloon and stent assembly into the main vessel, the bifurcated balloon comprising at least one inflatable portion; (ii) positioning the assembly at the bifurcation; (iii) inflating the bifurcated balloon thereby expanding the inflatable portion and deploying the stent in the main vessel and outwardly toward the branch vessel.
17. A balloon catheter, comprising: a catheter having a distal end, a proximal end and an inflation lumen; a balloon formed on the distal end of the catheter, the balloon being in fluid communication with the inflation lumen and being capable of being expanded from an unexpanded configuration to an expanded configuration, wherein the balloon is generally cylindrical in the unexpanded configuration and has a herniation in the expanded configuration.
18. A herniated balloon catheter, comprising: a balloon constructed from a composite material and including a woven material formed with a herniation, wherein the balloon has a herniation in the expanded condition.
21. A stent delivery system, comprising: a catheter having a balloon with a herniation; and a stent having a side opening including an outwardly expandable portion, the stent being disposed on the balloon with the stent side opening aligned with the herniation, whereby upon expansion of the balloon the herniation expands causing the outwardly expandable portion of the stent to extend toward a branch vessel.
22. A method for treating a bifurcated blood vessel, the method comprising: introducing into the blood vessel a catheter having a distal end, a proximal end, a guide wire lumen that is adapted to receive a guide wire, and a balloon having a distal end and a proximal end, the balloon being disposed near the distal end of the catheter, the balloon having a protrusion at a location between the distal end and proximal end of the balloon, and a stent having a side opening through a wall thereof, the stent being disposed over the balloon, wherein the protrusion of the balloon is positioned adjacent the side opening; positioning the catheter at a bifurcation by aligning the stent side opening with a side branch blood vessel; and expanding the balloon so as to deploy the stent such that the side opening of the stent is aligned with the opening of the bifurcated vessel.
24. A system for treatment of a bifurcation of a body lumen, the birfucation comprising a main vessel and a branch vessel, the system comprising: a catheter for insertion into said body lumen, the catheter having a distal end, a proximal end, and an inflation lumen; a balloon in fluid communication with the inflation lumen, the balloon having a first branch and a second branch, the second branch comprising an inflatable portion having a generally bulbous shape adapted to extend toward the branch vessel upon inflation; and a stent disposed on the balloon, the stent having an opening including an outwardly expandable portion, the opening aligned with the inflatable portion, whereby expansion of the inflatable portion causes the outwardly expandable portion to extend toward the branch vessel.

References: § 1
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