Source: https://patents.google.com/patent/EP2111825A1/en
Timestamp: 2019-04-21 14:50:20+00:00

Document:
The present invention relates to an apparatus for treatment of a bifurcation of a body lumen, the bifurcation having a main vessel and a branch vessel, wherein the apparatus includes a balloon catherer, comprising a catherer having an inflation lumen and a balloon formed on the distal end of the catherer and in fluid communication with the inflation lumen, the balloon having a herniation in the expanded configuration.
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.
The following items are preferred embodiments of the invention.
2. The apparatus of item 1, wherein the inflatable portion of the second branch portion is generally spherical.
3. The apparatus of item 1, wherein the inflatable portion of the second branch portion is generally elliptical and comprises a major and minor axis.
4. The apparatus of item 1, wherein the inflatable portion of the second branch portion is generally in the form of an offset bulbous shape.
5. The apparatus of item 1, wherein the inflatable portion of the second branch portion is generally in the form of an offset elliptical cylinder.
6. The apparatus of item 1, wherein the inflatable portion of the second branch portion is generally in the form of an offset cylinder.
7. The apparatus of item 1, wherein the second branch comprises a plurality of inflatable portions.
8. The apparatus of item 7, wherein said plurality comprises more than two inflatable portions.
9. The apparatus of item 8, wherein the inflatable portions are circumferentially spaced about the first branch portion.
10. The apparatus of item 8, wherein the inflatable portions are longitudinally spaced along the first branch portion.
11. The apparatus of item 1, wherein the first and second branches share a common inflation lumen.
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.
14. The system of item 13, wherein the stent includes an extendible branch portion configured and dimensioned to extend into a branch vessel upon expansion of the stent.
16. The method of item 15, wherein the bifurcated balloon comprises a first branch and a second branch, the at least one inflatable portion being disposed on the second branch of the bifurcated balloon.
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.
19. The herniated balloon catheter according to item 18, wherein the herniation is formed by balloon material.
20. The herniated balloon according to item 18, wherein the herniation is formed by adhesive attached to the balloon.
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.
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.
wherein the expanding balloon deploys the outwardly expandable portion of the stent toward a side branch blood vessel.
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.
25. The system of item 24, wherein the first branch and the second branch each have a longitudinal axis, the longitudinal axis of the first branch portion being substantially parallel to the longitudinal axis of the second branch portion.
26. The system of item 24, wherein the inflatable portion is generally in the form of an elliptical cylinder.
27. The system of item 24, wherein the inflatable portion is generally in the form of an offset cylinder.
28. The system of item 24, wherein the inflatable portion inflatable portion is generally in the form of an offset bulbous portion.
29. The system of item 24, wherein the second branch portion comprises a plurality of inflatable portions.
FIG. 20 is a cross-sectional view af still another embodiment of an alternative balloon construction formed according to the principles of the present invention.
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.
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.
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.
In one embodiment, the stent delivery system 10 is positioned near bifurcation 40, and with the distal end 16 (FIG. 1) positioned near side branch vessel 44 (FIGS. 3-6), second guidewire 38 is advanced into side branch vessel 44 from side sheath 20. Then, the first and second inflatable portions of balloon 26 are positioned adjacent the opening of side branch vessel 44 such that auxiliary inflatable side portion 32 of bifurcated balloon 26 is aligned with side branch vessel. In one exemplary embodiment, alignment may be achieved using markers, as described in U.S. Patent No. 6,692,483 to Vardi, et al ., the entire contents of which is incorporated herein by reference. Second guidewire 38 remains in side branch sheath 20, and the distal end 16 of system 10 remains in main vessel 42. First guidewire 36 remains within first guidewire lumen 22, and may be further advanced and positioned in main branch vessel 42.
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, D1 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 /D1 is on the order of about 0.8. According to further exemplary non-limiting embodiments, the major diameter D1 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 D1 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 241T and distal transition 243T , 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 341T and distal transition portion 343T , respectively. The offset central section 333 is preferably configured such that it comprised a first diameter D1 and second diameter D2 wherein D1 and D2 have different values (D1 ≠ 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 /D1 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 D1 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 441T and distal transition portion 443T , 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.
Another alternative herniated balloon construction is shown in FIG. 14, where the herniated balloon portion 526'' is provided with an alternatively configured herniation 533''. Illustrative and non-limiting examples of suitable dimensions according to this embodiment include: an outside diameter OD3 (FIG. 15) of about 1-10mm; a length dimension L3 of about 4-100mm; a height dimensions H of the herniation 533'' of about 1-6mm; and a radius of curvature R3 of the herniation 533'' of about 0.5-3mm; and a wall thickness of the herniated balloon catheter portion 526'' of about 0.01mm.
Although the herniation 533, 533', and 533'' of the embodiments illustrated in FIGS. 12-15 are shown as being centrally located on the herniated balloon catheter 526 or herniated balloon catheter portions 526', 526'', it should be noted that the herniation 533, 533', and/or 533" maybe located at any desired position along the length of the balloon. For example, once associated with a stent, it can preferably be placed such that it corresponds to the location along the middle 1/3 of the stent.
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.
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 has a herniation in the expanded configuration.
The balloon catheter of claim 1 wherein, in the unexpanded configuration, the balloon is generally cylindrical and, in the expanded configuration, the balloon is generally cylindrical and has the herniation.
The balloon catheter of any of claims 1-3 wherein the herniation expands towards the entrance of a branching vessel.
The balloon catheter of any of claims 1-4 wherein the herniation is centrally located on the balloon.
The balloon catheter of any of claims 1-5 further comprising a stent disposed about a portion of the balloon.
The balloon catheter of claim 6 wherein the herniation is located adjacent to a middle one-third portion of the stent.
The balloon catheter of any of claims 1-7 wherein the stent has a side opening including an outwardly expandable portion, the stent being disposed on the balloon with the stent side opening aligned with the herniation, wherein expansion of the herniation of the balloon causes the outwardly expandable portion of the stent to extend toward a branch vessel.
The balloon catheter of any of claims 1-8 wherein the herniation is formed by adding an appendage to a generally cylindrical balloon.
The balloon catheter of any of claims 1-8 wherein the herniation is formed by molding different balloon materials together in tandem.
The balloon catheter of any of claims 1-8 wherein the herniation is formed by adhesive attached to the balloon.
a balloon disposed adjacent a distal end of the catheter shaft and in fluid communication with the inflation lumen, the balloon constructed from a composite material and has a herniation in the expanded condition.
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 bulge portion, wherein expansion of the bulge portion of the balloon causes the outwardly expandable portion of the stent to extend toward a branch vessel.

References: § 1
 Application No. 60
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 Application No. 60
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 Application No. 10