Source: https://patents.google.com/patent/CA2544416A1/en
Timestamp: 2018-06-22 06:13:56
Document Index: 385388744

Matched Legal Cases: ['art;\n7', 'art 92', 'art 9', 'art 92', 'art 92', 'art 92', 'art 92', 'art 92', 'art 92', 'art 104', 'art 102', 'art 104', 'art 104', 'art 102', 'art 102', 'art 104', 'art 124', 'art 124', 'art.\n38']

CA2544416A1 - Treatment of vascular bifurcations - Google Patents
CA2544416A1
CA2544416A1 CA 2544416 CA2544416A CA2544416A1 CA 2544416 A1 CA2544416 A1 CA 2544416A1 CA 2544416 CA2544416 CA 2544416 CA 2544416 A CA2544416 A CA 2544416A CA 2544416 A1 CA2544416 A1 CA 2544416A1
CA 2544416
TREATMENT OF VASCULAR B~IFURCATIONS
This application claims the benefit of U.S. Provisional Patent Application 60/517,213, filed November 3, 2003, and U.S. Provisional Patent Application 60/607,064, filed September
2, 2004. The disclosures of these related applications are incorporated herein by reference.
The present invention relates generally to vascular catheterization, and specifically to intravascular balloons and stems.
Intravascular stems are used for various proposes, including opening occluded blood vessels. Typically, the stmt is supplied in a narrow, contracted form, with a deflated balloon contained inside the stmt. The stmt and balloon are held at the distal end of a catheter. The physician inserts a guide wire into the blood vessel, and then slides the catheter over the wire to position the stmt in the proper location. The balloon is then inflated, via a channel in the catheter, causing the stmt to expand so as to be anchored in place and hold the vessel open.
Once the stmt has been expanded, the balloon is deflated and is withdrawn, along with the catheter, from the vessel.
It is sometimes necessary to insert a stmt at the location of a bifurcation, where two blood vessels meet. In such cases, the stmt must be inserted into the vessel that is to be expanded in such a way that the other vessel at the bifurcation is not blocked by the stmt or damaged by the procedure. The physician performing the procedure must also take care not to dislodge plaques from either of the vessels at the bifurcation while perfimming the treatment.
The difficulty of treating vascular bifurcations is recognized in the art, and a variety of solutions have been proposed. For example, U.S. Patent 6,361,544, whose disclosure is incorporated herein by reference, describes a stmt and catheter assembly for treating bifurcations. The stents described in the patent include stems for side-branch vessels, with an angulated portion that corresponds to tile angle formed by the intersection of the side-branch vessel and the main vessel; main-vessel stents, which have a.n aperture that aligns with the opening to the side-branch vessel; and Y-shaped stems. Side-branch and main-vessel catheter assemblies are advanced over a pair of guide wires for delivering, appropriately orienting, and implanting the stems. A dual-balloon Y-shaped catheter is also described.
Bifurcated balloons for use in catheterization procedures are also described, for example, in U.S. Patents 6,017,324, 6,210,380 and 6,123,718 and in U.S. Patent Application Publication 2003/0069561. The disclosures of these patents and patent application are incorporated herein by reference.
SUlVIIVIARY OF THE INVENTION
Embodiments of the present invention provide novel balloons for treatment of vascular bifiucations, as well as methods for nnplantmg stems in the area of a blfilrCatlon using such balloons. (The term "biftlrcation" as used herein refers to the area where two blood vessels meet, and includes the ostium.) These methods permit physicians to position stems with el~llanced accuracy and ease. The balloons are also usefid in reducing the likelihood that plaques will be released into the bloodstream during the procedure.
In some embodiments of the present invention, an intravascular ball00n COIIIprISeS two parts with different inflation characteristics. In other words, the two parts of the balloon are configured to respond differently to a given inflation pressure. Typically, when the balloon is inflated at a vascular bifurcation, one of the two pal-ts of the balloon deploys into one vessel, while the other pact deploys into the other vessel.
In some of these embodiments, the bifurcated balloon comprises a main, longitudinal pal-t, with a radial protnlsion at a predefined location and angle along the length of the main section. A stmt is typically crimped over the balloon. The stmt may have a side opening, such that when inflated, the radial protnlsion of the balloon protldes through the side opening of the stmt. In one embodiment, the side opening is covered by radial struts, which open under pressure by the radial protr<lsion. The physician uses the protrusion to align the side opening of the stmt with the side vessel at the bifilrcation. Once the stmt has been properly aligned in this manner, the balloon is fully inflated, causing the stmt to expand and thus to be anchored in place, in optimal alignment with the side vessel. The balloon is then deflated and withdrawn.
Alternatively, the balloon may be used independently of a stmt, for example, in balloon angioplasty procedures to open occluded blood vessels near bifilrcations in the vessels.
In this case, the radial protnlsion of the balloon into the side vessel is still useful in aligning the balloon and preventing plaques at or near the bifilrcation from breaking loose as one of the vessels is expanded. This added benefit of preventing plaque release may also be provided when the bifurcated balloon is used in expanding a stmt, as described above.
In other embodiments, a balloon comprises a narrow inner part, for insertion into a side vessel at a bifurcation, and a collar, which surrounds one end of the narrow inner part of the balloon. The collar is configured to inflate to a lamer diameter than the inner paz-t. During treatment, the narrow part of the balloon is insez-ted into the side vessel so that the collar is positioned at the ostium, where the side vessel joins the main vessel.
Inflation of the balloon causes the inner part to expand within the side vessel, while the collar, whose inflated diameter is larger than the side vessel, remains in the main vessel. In one embodiment, the inflated collar serves as a stop against the ostiuzn, and thus aids the operating physician in positioning the stent properly at the ostium. In another embodiment, the balloon is used in implanting a novel stmt in the side vessel, wherein one end of the stmt protnzdes fiom the side vessel into the main vessel and is expanded by the collar to a larger diameter than the rest of the stmt in order to engage the ostium.
a first paz-t, which has a first inflation characteristic and is adapted to be deployed in the first blood vessel; and a second part, which has a second inflation characteristic, different from the first inflation characteristic, and is adapted to be deployed in the second blood vessel.
In some embodiments, the second part is adapted to protnzde radially fi-orn the first part when the balloon is inflated. Typically, the second part is adapted, upon paz-tial inflation of the balloon, to extend into the second blood vessel so as to facilitate aligmnent of the balloon with the vascular bifurcation.
hl one embodiment, the second part includes a fan-fold, which is adapted to unfold upon inflation of the balloon so that the second paz-t extends into the second blood vessel. In another embodiment, while the balloon is deflated, at least a portion of the second part is contained inside the first part, and the second part is adapted to extend outward from the first part upon inflation of the balloon. In still another embodiment, the apparatus includes a retraction mechanism, which is coupled to the second part so as to retract the second part radially toward the first part L1p011 deflation of the balloon.
3 In one aspect of the invention, the apparatus includes a radiopaque marker in at least a portion of the second pal-t, wherein the marker is configured so as to permit visualization of an alignment of the balloon relative to the bifurcation under angiographic imaging. In one embodiment, the radiopaque marker includes a ring encircling the second part.
In another embodiment, the apparatus includes a stmt, which is fitted over the first pal-t of the balloon and is adapted to be deployed wlth In the first blood vessel by inflation of the balloon, wherein the stmt has a radial opening to permit access between the first and second blood vessels, and wherein the second part of the balloon is adapted to protnlde radially through the radial opening in the stmt. The stmt may be adapted to elute a therapeutic substance.
In one aspect of the invention, the inflation characteristic includes a degree of compliance, SLICK that the first and second parts of the balloon have different, respective degrees of compliance. In one embodiment, the second part of the balloon includes a sleeve, which is secured over a portion of the first part of the balloon so as to constrain the compliance of the portion of the first pal-t.
In some of these embodiments, the first part of the balloon is adapted, upon the inflation of the balloon, to engage an ostium. In one embodiment, the apparatus includes a stmt, which is fitted over the second part of the balloon and is adapted to be deployed within the second blood vessel by the inflation of the balloon, the stmt including a proximal end that is adapted to be expanded to a size greater than the second diameter, and the first part of the balloon is adapted to expand the proximal end of the stem so as to anchor the proximal end against the ostium. The proximal end of the stmt may include a plurality of stnlts, which are configured to be expanded to the size greater than the second diameter. In another embodiment, the first pal-t of the balloon, when expanded, is adapted to serve as a stop against the ostium so as to aid in alignment of the stmt within the second blood vessel.
4 Typically, at least one of the first and second parts of the balloon has a lumen passing therethrough to accommodate a guide wire used in the deplo5mzent of the balloon. W some embodiments, no more than one of the first and second parts of the balloon has the lumen passing theretln-ough. The first and second parts of the balloon share a connnon intlation port or may have separate, respective inflation ports.
pTOVIdIIlg a balloon including a first part, which has a first inflation characteristic, and a second pact, which has a second inflation characteristic, different from the first inflation characteristic;
deploying the balloon at the vascular bifurcation, SLlch that the first part is deployed in the first blood vessel and the second part is deployed in the second blood vessel; and inflating the first and second parts of the balloon within the first and second blood vessels, respectively.
a balloon for deployment at the vascular bifurcation, the balloon including a first part, which has a first inflation characteristic and is adapted to be deployed in the first blood vessel, and a second part, which has a second inflation characteristic, different from the first inflation characteristic, and is adapted to be deployed in the second blood vessel; and a catheter, having a distal end to which the balloon is coupled, and which is adapted to pass tluough the first blood vessel so as to deploy the balloon at the bifurcation.
fabricating a first part of the balloon so as to have a first inflation characteristic; and fabricating a second part of the balloon, coupled to the first part, so as to have a second inflation characteristic, which is different from the first inflation characteristic.
W one embodiment, fabricating the first and second parts of the balloon includes fabricating at least one of the first and second parts by injection molding using a bifurcated mold.
5 In another embodiment, fabricating the first and second parts of the balloon includes fabricating at least one of the first and second parts by blow molding using a bifiucated mold.
The bifurcated mold Inay include a telescopic mold. Alternatively, fabricating the at least one of the first and second pal-ts includes applying at least one of suction and an angled pin to direct material into the bifurcated mold.
In still another embodiment, fabricating the first and second parts of the balloon includes fabricating the first and second parts by dipping a biiitrcated model in a liquid polymer.
There is moreover provided, in accordance with an embodiment of the present invention, a vascular stmt, including:
a distal section, which is adapted to be deployed and expanded within a blood vessel of a given diameter in a location adjacent to an ostium; and a proximal section, which is adapted to be expanded against the ostittm to a size greater than the given diameter so as to anchor the proximal section against the ostium.
In one embodiment, the distal section of the stmt includes a first number of stl-uts along a perimeter of the stmt, and the proximal section of the stmt includes a second number of the struts, greater than the first number. In another embodiment, the proximal section includes a plurality of stints, which are configured to bend outward so as to engage the OStILtIIl.
At least one of the distal and proximal sections may be adapted to elute a therapeutic substance.
a first part, which is adapted to be deployed in the first blood vessel; and a second part, which is adapted to protrude radially from the first part when the halloon is inflated so as to facilitate alignment of the balloon with the vascular bifurcation.
In some embodiments, the apparatus includes a stem, which is fitted over the first part of the balloon and is adapted to be deployed within the first blood vessel by intiation of the
6 balloon, wherein the stmt has a radial opening to permit access between the first and second blood vessels, and wherein the second part of the balloon is adapted to protrude radially through the radial opening in the stmt. In one embodiment, the stmt includes stouts over the radial opening, and wherein the second part of the balloon is adapted to open the straits outwward when the balloon is inflated.
There is also provided, in accordance with an embodiment of the present invention, apparatus for treatment of a vascular bifurcation, where a first blood vessel meets a second blood vessel, wherein the first and second blood vessels have characteristic first and second diameters, wherein the first diameter is greater than the second diameter, the apparatus including a balloon for deplo5nnent at the vascular bifurcation, the balloon including:
an inner part, which is adapted to be deployed in the second blood vessel; and a collar around the imler part, which is adapted, upon inflation of the balloon while the second pact is deployed in the second blood vessel, to assume an expanded diameter greater than the second diameter.
III some embodiments, the collar is adapted, upon the inflation of the balloon, to engage an ostium. In one embodiment, the apparatus includes a stmt, which is fitted over the imer part of the balloon and is adapted to be deployed within the second blood vessel by the inflation of the balloon, the stmt including a proximal end that is adapted to be expanded to a size greater than the second diameter, and the collar is adapted to expand the proximal end of the stmt so as to anchor the proximal end against the ostium. 111 another embodiment, the collar, when expanded, is adapted to serve as a stop against the ostium so as to aid in alip Inent of the stmt within the second blood vessel.
deploying the balloon in a vicinity of the vascular bifurcation, such that the first pant is deployed in the first blood vessel;
partially inflating the balloon in the vicinity of the vascular bifurcation so that the second part protmdes radially away from the first part;
7 aligning the second part of the pal-tially-inflated balloon with the second blood vessel;
and fillly inflating the balloon after aligning the second part.
There is further provided, in accordance with an embodiment of the present invention, a method for treatment of a vascular biftlrcation, where a first blood vessel meets a second blood vessel, wherein the first and second blood vessels have characteristic first and second diameters, wherein the first diameter is greater than the second diameter, the method including:
providing a balloon including an inner part and a collar around the imier pal-t;
deploying the balloon at the vascular bifilrcation, such that the inner part is deployed in the first blood vessel and the collar is deployed in the second blood vessel;
and inflating the balloon so that the collar expands to an expanded diameter greater than the second diameter and engages an ostium.
BRIEF DESCRIPTION ~F TIE DRAWINGS
Figs. 1-3 are schematic side views of a stmt and balloon used in implanting the stmt at a bifurcation in a blood vessel, at successive stages in the process of implantation, in accordance with an embodiment of the present invention;
?0 Fig. 4 is a schematic, pictorial view of a stmt fox implantation at a L~ifiu~cation, in accordance with another embodiment of the present invention;
Figs. 5-7 are schematic pictorial illustrations of a balloon that is aligned with and inflated within a bifilrcation in a blood vessel, at successive stages in the process of aliglunent and inflation, in accordance with another embodiment of the present invention;
Fig. 9 is a schematic, pictorial illustration showing insel-tion of a balloon into a bifin-cation in a blood vessel, in accordance with an embodiment of the present 111Ve11t1011;
Figs. 10 and 11 are schematic, pictorial illustrations showing a balloon with a radial protnlsion and a mechanism for retraction of the radial protlllsion at successive stages in the process of insertion of the balloon into a bifurcation of a blood vessel, in accordance with an e111bOdllllellt of the present invention;
s Fig. 12 is a schematic, pictorial illustration of a stmt, in accordance with an embodiment of the present invention;
Fig. 17 is a schematic, pictorial illustration of a stmt, in accordance with another embodiment of the present invention; and Figs. 18 and 19 are schematic, pictorial illustrations showing successive stages in a process of implanting a stmt in a side vessel at a bifurcation, in accordance with another embodiment of the present invention.
Fig. 1 is a schematic side view of a stmt '20, which is inserted into a blood vessel 24 at the location of a bifurcation in the vessel, in accordance with an embodiment of the present invention. The bifurcation in this example is the meeting point of vessel 24 with a side vessel 26. Vessel 24 is referred to hereinbelow as the "main vessel," because it is the blood vessel through which stmt 20 is inserted into the bifurcation. Typically, the main vessel has a larger diameter and carries a relatively larger volume of blood than does side vessel 26. In general, however, the principles of the present invention may be applied in treating both "main vessels"
and "side vessels" in a bifurcation, regardless of the relative sizes of the vessels. lil other words, the terms "main vessel" and "side vessel" are used in the present patent application and in the claims solely for convenience and clarity of explanation, and should not be construed as limiting the applicability of embodiments of the present invention to one sort of blood vessel or another.
Stent 20 is typically crimped on a balloon 32, which is inserted over a guide wire 22 into vessel 24 in order to treat plaques 30 obstructing the vessel in the area of the bifurcation.
Initially, during insertion of the stmt tlurough vessel 24, balloon 32 remains deflated, and the stmt has a narrow diameter, as shown in Fig. 1. The stmt has a side opening 28 that must be alit' ed with side vessel 26 at the bifurcation in order to permit access to the side vessel, to enable blood flow in the side vessel after the stmt has been expanded, and possibly additional treatment in the side vessel, as well. (The side opening of the stmt may optionally be initially closed by a suitable structure, such as radial struts, as shown in Fig. 4.) The stmt is typically constructed from a biocompatible metal or other rigid, expandable material, and may be con figured to elute a therapeutic substance following implantation, using methods and formulations lazown in the art.
Reference is now made to Figs. 2 and 3, which are schematic side views of stmt 20 in blood vessel 24 in successive stages of implantation of the stmt, in accordance with an embodiment of the present invention. In the stage shown in Fig. 2, balloon 32 inside stmt 20 is partially inflated, causing a radial protnlsion 34 of the balloon to protmde through the side opening of the stmt. This radial protnlsion may be made inherently more compliant than the main body of balloon 32 by appropriate treatment of the balloon at the time of manufacture.
(Methods of manufacture that may be used for this purpose are described hereinbelow.) Alternatively, the radial protnlsion may be more compliant simply because it is located inside opening 28 and thus is not constrained by the stmt. Typically, in the stage shown in Fig. 2, the balloon is inflated to a low pressure, for example, about '/.~ atm, via a fluid channel in the catheter (not shown) that is used to insert the stmt. The low pressure is sufficient to cause the radial promision to expand through the side opening, but is not sufficient to cause the main body of the balloon (inside the stmt) to make the stmt itself expand.
The operating physician performs two steps in order to align side opening 28 of stmt 20 with side vessel 26: rotation of the stmt about its longitudinal axis, and longitudinal lllot1011 of the stmt along the axis. Typically, the physician uses X-ray imaging or other radiographic imaging of the blood vessels and stmt for assistance during these steps.
Additionally or alternatively, protnlsion 34 of the balloon may give the physician tactile feedback, indicating when the protrusion has entered the opening of the side vessel. In some embodiments, the balloon is partially inflated, as shown in Fig. 2, prior to the rotation step.
111 other embodiments, the balloon is partially inflated only after the stmt has been turned to the proper orientation, and the protnlsion of the balloon is thus used primarily for longitudinal aligmnent of the side opening of the stmt with the side vessel.
In some embodiments, balloon 32 is inflated with a radiopaque fluid, such as saline solution mixed with a suitable contrast agent. The operating physician is then able to see the balloon - and in particular to see the location of radial protnlsion 34 of the balloon - under 1-ray imaging. Until side opening 28 of stmt 20 is properly positioned adjacent to the entrance of side vessel 26 at the bifurcation, the radial protrusion of the balloon will be at least partly compressed by the walls of main vessel ?4 or by plaques 30 within the vessel.
When the side opening of the stmt is properly alit' ed, however, the physician will see that the radial protrusion of the balloon has expanded outward into the side vessel, as shown in Fig. ?.
After stmt 20 has been correctly positioned using the partially-inflated balloon 32, the balloon is inflated to fiill pressure, as shown in Fig. 3. For example, the pressure in the balloon may be increased at this pOlllt t0 abOLlt 1.5 to 2 atm, which is typically sufficient to expand the stmt. Radial protrusion 34 of the balloon expands further under the increased pressure, and presses against the plaques in the area of the bifurcation.
Expansion of the balloon protrusion has two desirable effects: (1) During expansion of the stmt, the protmsion holds side opening 28 of the stmt in precise aliment with side vessel 26. (2) The balloon helps to prevent collapse of the walls of side vessel 26 and to prevent plaques 30 from brealcing loose from the vessel walls while the stmt is being expanded. When the side vessel walls collapse or plaques do break loose, dangerous and even fatal consequences may result downstream. These latter anti-embolic effects of the bifurcated balloon are also useful when the balloon alone is used to expand a bifurcated vessel, even in the absence of a stmt.
Once the stmt has been fully expanded, balloon 32 is deflated and is then withdrawn from the vessel, leaving stmt 20 in place. (Guide wire ?2 is also withdrawn, of course.) Radial protrusion 34 of the balloon is made small enough so that upon deflation, it is drawn back through side opening 28 of the stmt, without risk of being stuck in place. As noted above, the protmsion typically has a different inflation characteristic from the remainder of balloon 32 in order to facilitate the process of differential inflation described above. For example, protmsion 34 may be made of a flexible but relatively inelastic material, to prevent it ~S 110I11 being overinflated when high pressure is applied to expand the stmt.
Fig. 4 is a schematic, pictorial illustration of a stmt 35, in accordance with another embodiment of the present invention. 8tent 35 has a side opening 36, which is initially closed by radial straits 37. Once stmt 35 is properly located in a vascular bifurcation, inflation of the radial protnision of the balloon (not shown in this figure) causes struts 37 to open outward into the side vessel thus supporting the ostium. The balloon is subsequently deflated and withdrawn.
Figs. 5 and 6 are schematic side views illustrating insertion and alignment of a balloon 40 at a bifurcation of vessels 24 and ?6, in accordance with an embodiment of the present invention. Balloon 40 may be used in conjunction with a stmt, as in the preceding embodiment, or on its own as shown in Figs. 5 and 6. The balloon comprises a main body 42 and a radial protrusion 44, which is encircled by a radiopaque marker 46. The balloon in this case, too, is designed to be inserted into the area of the bifurcation by a catheter 48 over guide wire 22, without the assistance of a guide wire in side vessel 26.
Alternatively, a guide wire may be inserted into side vessel 26 in addition to or instead of guide wire 22 in vessel 24, or the balloon may be inserted in the bifurcation without the use of a guide wire.
111 one embodiment, marker 46 comprises a wire coil, which encircles protnision 44.
For example, the coil may comprise a superelastic shape-memory alloy, such as Nitinol, which is fabricated so that normally, in the absence of external forces, the coil has the compressed shape shown in Figs. 5 and 6. Typically, the coil is embedded in the balloon material.
Alternatively, the coil may be positioned either inside or outside protnision 44. Prot111sion 44 may have a fan-fold form, with multiple accordion-like folds. In order to align protnision 44 with side vessel 26, the operating physician observes the area of the bifurcation using a suitable imaging system, such as an angiography system or other type of fluoroscope. The imaging system is aligned so that the image plane is parallel to the plane containing both of vessels 24 and ?6 at the bifurcation, i.e., the plane of the page in Figs. 5 and 6. In Fig. 5, ?0 protnision 44 has not yet been aligned with side vessel ?6, and marker 46 therefore appears in the angiographic image as an ellipse. The physician rotates catheter 48 until protnision 44 is aligned with the opening of vessel 26, whereupon marker 46 appears as a straight line, as shown in Fig. 6.
Fig. 7 is a schematic side view showing inflation of balloon 40 inside the bifurcation.
The balloon is inflated, as in the other embodiments described herein, by injection of a suitable fluid tluough catheter 48. The inflation pressure causes protrusion 44 to unfold and thus expand into side vessel 26. As a result, marker 46 expands, so that the tLlnlS
of the coil are separated from one another. After the procedure is completed, and the balloon is deflated, the coil contracts baclc to its original shape, pulling protrusion 44 in toward main body 42 of balloon 40, and thus facilitating its removal from the body.
Alternatively, other means may be used to mark protrusion s4 or 44 for the purposes of aligiunent with bifiucation 26. For example, instead of a wire coil, marker 4G
may comprise one or more wire rings. Further alternatively, a radiopaque paint or dye may be embedded in tile wall of the balloon in the area of the protrusion. In one embodiment, marker 46 comprises a ring of radiopaque paint around the base of protlsion 46, which will have a similar appearance under angiography to the wire coil described above. Further alternatively, protmrsion 44 may comprise a central lumen to accommodate a guide wire, as shown in the next embodiment.
Fig. 8 is a schematic, pictorial illustration of a balloon 50, in accordance with another embodiment of the present invention. Balloon 50 comprises a main body 54 and a radial prOtrLrS1011 52, as in the preceding embodiments. In this case, however, until balloon 50 is inflated inside the bifurcation, radial protrusion 52 is inverted and is thus contained inside main body 54. In this configuration, the radial protnlsion is inverted, so that it appears as an indentation, rather than a protrusion. The tip of radial protnlsion 52 has an opening 64 to permit an inner tube (not ShOwl1 111 this figure) containing a guide wire to pass through the radial protrusion into side vessel 26. Main body 54 of balloon 50 may contain an additional lumen (not shown) to acconllnodate another guide wire in the main vessel. As noted earlier, balloon 50 may be used to treat vascular bifurcations with or without an accompanying stmt.
Fig. 9 is a schematic side view of the bifilrcation of vessels 24 and 26, showing deployment of balloon 50 within the bifilrcation, in accordance with an embodiment of the present invention. A catheter 56, which is used to deploy balloon 50, comprises an inner tube 5c~, WhlCh paSSeS thl'ollgh Ope111ng 64 In the tlp Of prOtrLlSlOn 50. Ill the embodiment ShOWIl 111 Fig. 9, main body 54 of balloon 50 fits over a blind termination 60 at the distal end of the catheter. Alternatively, the tip of main body 54 play be open to accommodate a guide wire, as in the preceding embodiments. To insert balloon 50 in the bifiucation, a guide wire 62 is first inserted through vessel 24 into vessel 26, as shown in the figure. Catheter 56, with balloon 50 in its deflated state (as shown in Fig. 8), is then advanced over guide wire 62 into the area of the bifilrcation, so that inner tube 58 passes into side vessel 26, while termination 60 remains in main vessel 24. Inflation of balloon 50 then causes protllrsion 52 to even out of its initial position inside main body 54, shown in Fig. S, to the expanded configuration sllown in Fig. 9.
Alternatively, a balloon with a non-everting protl-llsion, as shown in Figs. 5 and 6, for example, may be insel-ted over a guide wire and inflated in the manner shown in Fig. 9.
Figs. 10 and 11 are schematic, pictorial illustrations showing a mechanism 70 that may be used to assist in retraction of radial protrwsion 52 after use, in accordance with an embodiment of the present invention. Fig. 10 shows protmsion 52 and mechanism 70 in the retracted position, while Fig. 11 shows the protmsion mechanism in the expanded position.
Although mechanism 70 is shown here in conjunction with balloon 50, similar mechanisms may be adapted for use with other types of radial protmsions that are described herein.
Mechanism 70 comprises an articulating retraction ann 72, which is attached at its distal end to the tip of protrusion 52 and is held at its proximal end by a spring. Initially, as shown in Fig. 10, during insertion of balloon 50 into the area of the bifurcation, spring 74 is relaxed, and ann 72 is thus retracted, holding protnision 52 in its inverted configuration inside main body 54 (i.e., in the configuration shown in Fig. 8). lizflation of balloon 50 causes protmsion 52 to extend out of main body 54. Extension of protmsion 52 pulls ann 72 ourivard along with it, in the distal direction, and compresses spring 74, as shown in Fig. 11. (Spring 74 is designed so that the tensile force it exerts is small enough to be overcome by the inflation pressure of protnision 52.) When balloon 50 is finally deflated, at the end of the procedure, spring 74 pulls ann 72 back in the proximal direction, and thLlS pulls protmsion 52 back to its initial position inside main body 54, as shown in Fig. 10. 11z this position, the operating physician can withdraw balloon 50 fiom the patient's body without interference by protmsion 52, Fig. 12 is a schematic, pictorial illustration of a stmt 80 for implantation in a side vessel at a bifurcation, in accordance with an embodiment of the present invention. Stent 80 is designed to engage the ostium, as described hereinbelow. As in other embodiments, stmt 80 comprises a suitable biocompatible material, which may be capable of eluting a therapeutic substance following implantation. Stent 80 comprises a distal section 82 of conventional construction and a proximal end made up of stints 84, which are capable of deforming ourivard to fit the shape of the ostitml, as shown in Fig. 15 below. Typically, the struts may bend outward by as much as 90°. During delivery of the stmt tlu-ough the vascular system, however, the entire stmt, including straits 84, is maintained in a contracted configuration, with an approximately constant diameter over the entire length of the stmt.
Fig. 13 is a schematic, pictorial illustration of a balloon 90, for use in intravascular treatment in the area of a bifurcation, in accordance with an embodiment of the present invention. The balloon is designed to engage the ostium in the bifin-cation.
Balloon 90 may be used, for example, in implanting stmt 80, as described below. Alternatively, balloon 90 may be used 011 1tS 0\~~ll 111 treatment of vascular bifurcations, without a stmt.
The balloon is shown in the figure in its fully-inflated CO11f1gL1I'at10I1; during delivery of the balloon through the vascular system, the balloon is typically deflated.
Balloon 90 comprises two parts with different inflation characteristics: an inner part 92, made of semi-compliant material, and collar 94, made of fully-compliant material, which S S11rr0uIldS the proximal end of inner part 9?. Typically, balloon 90 comprises a biocompatible polymer material, such as a suitable polyamide. In this embodiment, inner part 92 and collar 94 may be Fabricated as separate balloons, with the collar having the general form of a toroid fitted around the inner part. The inner part and collar may share a common inflation port, or they may alternatively have separate inflation ports, enabling the two parts to be inflated to different pressures. Although inner part 92 and collar 94 are seen in Fig. 13 to share a common axis, in an alternative embodiment (not shown in the figures), the axis of collar 94 may be angled relative to the axis of imer part 92. This angled configuration is useful, for example, in treating Y-shaped bifurcations.
Reference is now made to Figs. 14 and 15, which are schematic side views of the area of a vascular bifurcation, showing the stages in implantation of stmt 80 in side vessel 26 using balloon 90, in accordance with an embodiment of the present invention. This implantation procedure may be used in substantially any bifiu~cation, but it is especially useful for treating the ostia at bifurcations fi'olll large arteries, such as the bifurcation of the coronary arteries from the ascending aorta. As shown in Fig. 14, stmt 80, in its contracted state, is fitted and crimped over deflated balloon 90, so that the proximal end of the stmt extends over imier part 92 of the balloon and over the distal end of collar' 94. The stmt is delivered by a catheter 96 within a guiding catheter 97 over a guide wire 98, which has been tlweaded from main vessel 24 into side vessel 26. In this embodiment, balloon 90 has a central lumen with a distal opening for accommodating the guide wire. The central lumen may also permit blood flow in side vessel '?6, via the lumen, even when the balloon is fully inflated.
Once stmt 80 is in place in side vessel 26, the highly-compliant collar 94 of balloon 90 may be partially inflated, causing the collar to expand to a diameter greater than the diameter of side vessel 26. The operating physician at this stage may push catheter 96 fomvard, in the distal direction, so that collar 94 engages the ostium. This engagement ensures that stmt g0 is properly positioned for expansion. Alternatively, balloon 90 may be designed and operated so that collar 94 is inflated only after inner part 92 and stmt ~0 have been deployed and expanded in side vessel ?6.
Finally, as shown in Fig. 15, balloon 90 is fully inflated, causing the balloon to assume the shape shown in Fig. 13. Inner part 92 pushes distal section 82 of stmt SO
outward, to widen vessel 26. Meanwhile, collar 94 spreads struts 84 against the ostium to suppol-t the ostium and help to anchor the stmt in place. Balloon 90 is then deflated and withdrawn from the body through vessel 24 by using catheter 96.
Fig. 16 is a schematic side view showing constnlction of a balloon 100, in accordance with an alternative embodiment of the present invention. Balloon 100 comprises a semi-compliant distal pal-t 102 and a fully-compliant proximal part 104. Distal part 102, which has the form of a sleeve, is fitted over proximal part 104 and is then fixed in place, by gluing or fusing with heat or ultrasonic energy, for example. Upon inflation of balloon 100, the proximal end of proximal part 104 (at the upper right in Fig. 16) will inflate to a gl-eater diameter than the distal end, which is constrained by distal part 102. As a result, balloon 100 will assume the shape shown in Fig. 13. In other words, distal part 102 defines the imzer part of the balloon, while proximal part 104 defines the collar. Balloon 100 may thus be used in place of balloon 90 in the procedures described above and hereinbelow. Other balloon designs with differential compliance may similarly be used for this purpose and are considered to be Wlthlll the scope of the present invention.
Fig. 17 is a schematic, pictorial illustration of a stmt 110, in accordance with an alternative embodiment of the present invention. Stent 110 may be used in place of stmt 80 in the procedure described above.. As in other embodiments, stmt 110 comprises a suitable biocompatible material, which may be capable of eluting a therapeutic substance following implantation.
Stent 110 comprises a distal section 112 and a proximal end 114. The proximal end has a larger number of stnlts along its perimeter than does the distal section. As a result, proximal end 114 is capable of expanding to a larger diameter than section 112, as illustrated in Fig. 17 (which shows the stmt in a partly-expanded configuration). As in the preceding embodiments, stmt 110 is maintained in a contracted configuration during delivery of the stmt tlu-ough the vascular system, with an approximately constant diameter over the entire length of the stmt, and is then expanded fully in the bifurcation. The stmt designs illustrated in Figs. 12 and 17 are shown only by way of example, and alternative stmt designs that permit increased expansion of the proximal end of the stmt in the ostial area will be apparent to those skilled in the art. The proximal pal-t may be manufactured as an integl-al part of the stem in a single process, or it may alternatively be produced separately and attached to the distal section by welding or any other suitable method.
Figs. 18 and 19 are schematic side views of the area of a vascular bifurcation, showing the stages in implantation of a stmt 120 in side vessel 26 using a balloon 122, in accordance with an embodiment of the present invention. Balloon 122 is similar in design to balloon 90, as shown and described above. In this case, however, as shown in Fig. 18, stmt 120, in its contracted state, is fitted and crimped over deflated balloon 122 so that the stmt extends only over an inner part 124 of the balloon, without extending over a collar 126 of the balloon as in the preceding embodiment. 8tent 120 is delivered by catheter 96 over guide wire 98 within guiding catheter 97 into side vessel 26, as shown in Fig. 18.
Proper aligmnent of a stmt in the ostial area of a bifurcation using methods known in the art is a difficult task, typically requiring the use of radiopaque markers to permit the operating physician to visualize the position of the stmt. Balloon 122, however, enables the physician to precisely align stem 120 in the ostial area without the need for such markers. For this purpose, the physician inflates collar 126, as shown in Fig. 19. The physician then pushes catheter 96 in the distal direction so as to advance inner part 124 (with stmt 120 crimped over it) into side vessel 26. The inflated collar semles as a mechanical stop, halting the distal advance of the stmt at its desired location, just inside side vessel 26. The physician then completes the inflation of inner pant 124 in order to expand stmt 120 in place in the side vessel.
Lilce balloon 90, balloon 122 has a central lumen with a distal opening for accommodating guide wire 98. The central lumen may also permit blood flow in side vessel 26, via the lumen, even when the balloon is fully inflated.
a) Injection molding using a bifurcated mold with an open or closed protnision tip (depending upon whether the distal tip of the balloon is to have an opening, typically to accommodate a guide wire, as described above). Balloon raw material, in a liquid, powder or other form, is pre-heated and injected into the mold. After the material has settled inside the mold it is cooled and assumes the appropriate final shape.
b) Blow molding using a bifurcated mold. Balloon raw material in the form of a tube is placed inside the mold (either heated or at room temperature). This tube is then inflated using air, water or other material in order to apply internal pressure that shapes the tube to the geometry of the mold.
c) Blow molding using a bifurcated mold and a vacuum nozzle. This method is similar to that described in the preceding paragraph, with the addition of applying suction through the vacuum nozzle to pull the tube material into the form of the required protnlsion, as defined by the shape of the blow mold.
d) Blow molding using a bifurcated mold with a movable inner angled pin (in addition to or instead of applying suction) to direct the tube material in the mold so as to form the required protrusion.
e) Blow molding Llslllg a bifilrcated telescopic mold. The part of the mold that is used to form the radial protl-usion of the balloon is capable of stretching and contracting to form a protrusion of the type shown in Fig. 9, for example.
f) Dipping, using a liquid polymer and a bifurcated balloon model. To foam the balloon shown in Fig. S, for example, one branch of the model (which is used to form the radial protnlsion) is capable of being retracted into the model so that the model assumes a cylindrical shape. The balloon model, with the retractable branch extended, is dipped in a tub containing a liquid polymer, which attaches to the surface. The coated model is then removed from the tub and left to dry. After the polymer has hardened and stabilized, the retractable branch is retracted into the model in order to enable removal of the balloon.
g) Blow holding to create the main chamber of the balloon, followed by local treatment at the desired location under appropriate pressure conditions to create the side protnlsion. The local treatment may comprise heating, ultrasonic irradiation, or chemical treatment, for example.
Although the figures in this patent application illustrate certain particular COIIfIgLlratlOnS Of vessel bifurcations, stems and balloons, tlleSe COnf1gL11'atlOnS are ShOWIl only by way of example. Alternative configurations based on the principles of the present invention will be apparent to those skilled in the art. For example, in some of the embodiments shown in the figures, the vessel bifilrcation (and consequently the balloon) has a "T"
shape, while in other embodiments the bifilrcation and balloon are "Y" shaped. It will be appreciated that each of these embodiments may be adapted for use in bifilrcations of both "T"
and "Y" types, as well as for other, more complex shapes, according to the configuration of the blood vessels in question. Whereas some of the balloons shown in the figures are configured for insertion over a guide wire, the balloons (and the catheters used to insert them) may alternatively be configured for operation without a guide wire, or for insertion using rivo or more guide wires if S appropriate. The radial protrusion or proximal part of the balloons may also be fabricated as a separate chamber from the main part, as mentioned above, and may thus be inflated via a different chamiel and to a different pressure, if desired, from the main part of the balloon.
It thus will be appreciated that the embodiments described above are cited by way of example, and that the present invention is not limited to what has been particularly shown and described hereinabove. Rather, the scope of the present invention includes both combinations and subcombinations of the various features described hereinabove, as well as variations and modifications thereof which would occur to persons slcilled in the art L1p011 read111g the foregoing description and which are not disclosed in the prior art.
a first part, which has a first inflation characteristic and is adapted to be deployed in the first blood vessel; and a second part, which has a second inflation characteristic, different from the first inflation characteristic, and is adapted to be deployed in the second blood vessel.
5. The apparatus according to claim 2, wherein while the balloon is deflated, at least a portion of the second part is contained inside the first part, and wherein the second pant is adapted to extend outward from the first part upon inflation of the balloon.
22. The apparatus according to any of claims 1-21, wherein at least one of the first and second pants of the balloon has a lumen passing therethrough to accommodate a guide wire used in the deployment of the balloon.
24. The apparatus according to any of claims 1-21, wherein the first and second parts of the balloon share a con anon inflation port.
providing a balloon comprising a first part, which has a first inflation characteristic, and a second part, which has a second inflation characteristic, different from the first inflation characteristic;
deploying the balloon at the vascular bifurcation, such that the first part is deployed in the first blood vessel and the second part is deployed in the second blood vessel; and inflating the first and second parts of the balloon within the first and second blood vessels, respectively.
30. The method according to claim 27, wherein while the balloon is deflated, at least a portion of the second pal-t is contained inside the first part, and wherein inflating the first and second parts causes the second part to extend outward from the first part.
38. The method according to claim 26, wherein the first and second blood vessels have characteristic first and second diameters, wherein the first diameter is greater than the second diameter, and wherein inflating the first and second parts of the balloon comprises inflating the first pact to an expanded diameter greater than the second diameter.
41. The method according to claim 38, wherein deploring the balloon comprises positioning the balloon so that upon inflation of the balloon, the first part of the balloon engages an ostium.
42. The method according to claim 41, and comprising fitting a stet over the second pant of the balloon, wherein inflating the first and second parts of the balloon comprises deploying the stet within the second blood vessel by the inflation of the second part of the balloon, while expanding a proximal end of the stet to a size greater than the second diameter by the inflation of the first pant of the balloon so as to anchor the proximal end against the ostium.
43. The method according to claim 42, wherein the proximal end of the stet comprises a plurality of struts, and wherein expanding the proximal end comprises spreading the struts.
aligning the stet on the second part of the balloon inside the second blood vessel after inflating the first part of the balloon to the expanded diameter, so that the first part of the balloon serves as a stop against the ostium; and after aligning the second pant of the balloon, expanding the second part of the balloon so as to deploy the stent within the second blood vessel.
47. The method according to any of claims 26-46, wherein deploying the balloon comprises passing a guide wire through a lumen in at least one of the first and second pants of the balloon, and deploying the balloon at the vascular bifurcation over the guide wire.
49. The method according to any of claims 26-46, wherein inflating the first and second parts of the balloon comprises inflating both of the parts of the balloon through a common inflation port.
50. The method according to any of claims 26-46, wherein inflating the first and second parts of the balloon comprises inflating the first and second parts of the balloon through separate, respective inflation ports.
a balloon for deployment at the vascular bifurcation, the balloon comprising a first part, which has a first inflation characteristic and is adapted to be deployed in the first blood vessel, and a second part, which has a second inflation characteristic, different from the first inflation characteristic, and is adapted to be deployed in the second blood vessel; and a catheter, having a distal end to which the balloon is coupled, and which is adapted to pass through the first blood vessel so as to deploy the balloon at the bifurcation.
52. A method for manufacturing an intravascular balloon, comprising:
60. The method according to claim 59, wherein the bifurcated mold comprises a telescopic hold.
a distal section, which is adapted to be deployed and expanded within a blood vessel of a given diameter in a location adjacent to an ostium; and a proximal section, which is adapted to be expanded against the ostium to a size greater than the given diameter so as to anchor the proximal section against the ostium.
a first part, which is adapted to be deployed in the first blood vessel; and a second part, which is adapted to protrude radially from tile first part when the balloon is inflated so as to facilitate aliglnnent of the balloon with the vascular bifurcation.
71. The apparatus according to any of claims 68-70, and comprising a radiopaque marker in at least a portion of the second part, wherein the marker is configured so as to permit visualization of an alignment of the balloon relative to the bifurcation under angiographic imaging.
an roller part, which is adapted to be deployed in the second blood vessel;
and a collar around the inner part, which is adapted, upon inflation of the balloon while the second part is deployed in the second blood vessel, to assume an expanded diameter greater than the second diameter.
providing a balloon comprising a first part, which has a first inflation characteristic, and a second part, which is adapted to protrude radially from the first part when the balloon is inflated;
partially inflating the balloon in the vicinity of the vascular bifurcation so that the second part protrudes radially away from the first part;
aligning the second part of the partially-inflated balloon with the second blood vessel;
and fully inflating the balloon after aligning the second part.
providing a balloon comprising an inner part and a collar around the inner part;
deploying the balloon at the vascular bifurcation, such that the inner part is deployed in the first blood vessel and the collar is deployed in the second blood vessel;
aligning the stent on the inner part of the balloon inside the second blood vessel after inflating the collar to the expanded diameter, so that the collar serves as a stop against the ostium; and after aligning the inner part of the balloon, expanding the second part of the balloon so as to deploy the stent within the second blood vessel.
CA 2544416 2003-11-03 2004-11-02 Treatment of vascular bifurcations Abandoned CA2544416A1 (en)
CA2544416A1 true true CA2544416A1 (en) 2005-05-12
CA 2544416 Abandoned CA2544416A1 (en) 2003-11-03 2004-11-02 Treatment of vascular bifurcations
2009-11-02 EEER Examination request