Source: https://patents.google.com/patent/US20070282419
Timestamp: 2018-02-19 22:14:57
Document Index: 101677206

Matched Legal Cases: ['art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 314', 'art 310', 'art 310', 'art 310']

US20070282419A1 - Catheter system for stenting and drug treatment of bifurcated vessels - Google Patents
Catheter system for stenting and drug treatment of bifurcated vessels
US20070282419A1
US20070282419A1 US11789001 US78900107A US2007282419A1 US 20070282419 A1 US20070282419 A1 US 20070282419A1 US 11789001 US11789001 US 11789001 US 78900107 A US78900107 A US 78900107A US 2007282419 A1 US2007282419 A1 US 2007282419A1
US11789001
US9278015B2 (en )
A catheter system and method are described for stenting a vessel at a bifurcation or sidebranch of the vessel. The catheter system includes a first balloon catheter, a second balloon catheter and a releasable linking device for holding the first and second balloon catheters arranged in a side-by-side configuration and aligned with one another along a longitudinal axis so that the catheter system can be advanced as a unit. The catheter system is combined with drug eluting technology to prevent restenosis, inflammation and/or thrombosis and/or to promote reendothelialization in the vessel bifurcation. The main vessel stent and/or the sidebranch stent may be coated or impregnated with one or more drugs or bioactive substances. Alternatively or in addition, the first balloon and/or the second balloon may be coated with or include a mechanism for delivering one or more drugs or bioactive substances to the vessel wall.
This application is a continuation-in-part of U.S. Utility application ser. No. 11/319,767, filed Dec. 27, 2005, which is a continuation-in-part of U.S. Utility application Ser. No. 11/107,393, filed Apr. 15, 2005, which is a continuation-in-part of U.S. Utility application Ser. No. 10/833494, filed Apr. 27, 2004, which claims the benefit of U.S. Provisional Application, Ser. No. 60/512259, filed Oct. 16, 2003, and U.S. Provisional Application, Ser. No. 60/534469, filed Jan. 5, 2004, the disclosures of which are incorporated by reference in their entirety.
The following patents and patent applications relate to catheters and catheter systems for performing angioplasty, stenting and drug treatment of blood vessels. These and all patents and patent applications referred to herein are incorporated by reference in their entirety.
U.S. Pat. No. 5,395,352 Y-adaptor manifold with pinch valve for an intravascular catheter
US 20060020243A1 Medical device for dispensing medicaments
US 20050250672A9 Preparation for the prophylaxis of restenosis
US 20050101522A1 Preparation for the prophylaxis of restenosis
In one preferred embodiment of a catheter system for stenting bifurcated vessels, a first balloon catheter and a second balloon catheter are held together with a linking device with the first and second dilatation balloons arranged in a low-profile tandem configuration. The second balloon catheter has an elongated flexible tubular extension extending distally from the second dilatation balloon. The balloon material of the first dilatation balloon mounted on the first balloon catheter is folded around the flexible tubular extension of the second balloon catheter with only the distal tip of the flexible tubular extension exposed. A stent is crimped over the first dilatation balloon of the first balloon catheter and the flexible tubular extension of the second balloon catheter. Preferably, the distal tip of the flexible tubular extension emerges from the folds of the balloon material at an intermediate position on the dilatation balloon and extends through an open cell between two struts on the crimped stent. This configuration provides a smoother, more consistent surface for crimping the stent onto, which results in a smoother crossing profile for the catheter system. Optionally, any of the described embodiments of the catheter system may be provided with a chromium-cobalt alloy stent with a strut configuration optimized for stenting bifurcations.
In a second aspect, the invention comprises a linking device for holding the first and second balloon catheters of the system in a side-by-side configuration and aligned with one another along a longitudinal axis. The linking device allows the catheter system to be advanced as a unit and helps prevent premature or inadvertent dislodgement of the stent from the catheters.
Optionally, the linking device may also be configured to hold one or both of the guidewires stationary with respect to the catheter system. The linking device is preferably releasable so that one or both of the balloon catheters and/or the guidewires can be released from the linking device and maneuvered separately from the rest of the catheter system. In one embodiment the linking device is self-releasing in the sense that the linking device demounts itself from the first and second balloon catheters as the catheter system is advanced into the patient's body.
In a fourth aspect, the invention combines drug eluting technology with the catheter system for stenting bifurcated vessels. The main vessel stent and/or the sidebranch stent may be coated or impregnated with one or more drugs or bioactive substances to prevent restenosis, inflammation and/or thrombosis and/or to promote reendothelialization. Alternatively or in addition, the first balloon and/or the second balloon may be coated with or include a mechanism for delivering one or more drugs or bioactive substances to prevent restenosis, inflammation and/or thrombosis and/or to promote reendothelialization. In one exemplary embodiment that is envisioned for use in provisional stenting procedures, the catheter system is configured to deliver a main vessel stent, which is treated with a drug eluting coating or the like, into the main vessel of the bifurcation and the second balloon is coated with or otherwise includes a mechanism for delivering one or more drugs or bioactive substances to the sidebranch of the bifurcation.
FIG. 20 shows a distal portion of a fourth embodiment of a catheter system for stenting bifurcated vessels prior to mounting a stent on the first balloon catheter.
FIGS. 21A, 21B and 21C show cross sections of the catheter system for stenting bifurcated vessels taken along section lines A, B and C in FIG. 20.
FIG. 22 shows the catheter system for stenting bifurcated vessels of FIG. 20 with a main vessel stent mounted on the dilatation balloon of the first balloon catheter.
FIG. 23 illustrates a stent configured for stenting bifurcated vessels shown with the stent laid out flat to show the strut configuration of the stent.
FIGS. 24A, 24B and 24C are detail drawings of three portions of the stent of FIG. 23.
FIG. 25 illustrates another stent configured for stenting bifurcated vessels shown with the stent laid out flat to show the strut configuration of the stent.
FIGS. 26A, 26B and 26C are detail drawings of three portions of the stent of FIG. 25.
FIG. 27 illustrates a two-part stent configured for stenting bifurcated vessels shown with the stent mounted on a stent delivery catheter.
FIG. 28 is an enlarged detail drawing showing the non-linked zone of the two-part stent shown in FIG. 27.
FIG. 29 shows the two-part stent of FIG. 27 in an expanded state.
FIG. 30 shows the two-part stent of FIG. 27 expanded in a bifurcated vessel.
FIG. 31 shows the bifurcated vessel after stenting with the two-part stent of FIG. 27.
FIGS. 20-22 illustrate a distal portion of a fourth embodiment of a catheter system 100 for stenting bifurcated vessels. The catheter system 100 is similar in structure and configuration to the catheter system of FIG. 5 with a first balloon catheter 102 having a first inflatable balloon 130 and a second balloon catheter 104 having a second inflatable balloon 132 and a flexible tubular extension 134 extending distally from the second inflatable balloon 132. The first and second inflatable balloons 130, 132 are assembled together in a staggered or tandem initial position, as shown in FIG. 5, to provide a low crossing profile. The catheter system 100 can use any of the linking devices 160 described herein to maintain the longitudinal alignment of the catheters 102, 104 during insertion. In a particularly preferred embodiment, the catheter system 100 will utilize a linking device 160 in the form of an auto-release sheath constructed of an elongated split-tube 200, as illustrated in FIGS. 14-17.
FIG. 20 shows a distal portion of the catheter system 100 prior to mounting a stent on the first balloon catheter 102. The flexible tubular extension 134 of the second balloon catheter 104 extends distally from the second dilatation balloon 132 (see FIG. 5) to an intermediate position between the proximal and distal ends of the first inflatable balloon 130. The balloon material of the first inflatable balloon 130 is folded around the flexible tubular extension 134 of the second balloon catheter with only the distal tip 135 of the flexible tubular extension 134 exposed. This configuration provides a smoother, more consistent surface for crimping a stent onto the first inflatable balloon 130 and the flexible tubular extension 134, which results in a smoother crossing profile for the catheter system 100.
FIGS. 21A, 21B and 21C show cross sections of the catheter system 100 taken along section lines A, B and C in FIG. 20. FIG. 21A shows a cross section of the catheter system 100 taken through a distal portion of the first inflatable balloon 130 along section line A in FIG. 20. This distal portion of the first inflatable balloon 130 may be folded in any convenient low-profile balloon folding configuration, such as the three-wing folding configuration shown. Alternatively, the distal portion of the first inflatable balloon 130 may be folded in a two-wing or four-wing folding configuration or other balloon folding configuration known in the industry. FIG. 21C shows a cross section of the catheter system 100 taken through a proximal portion of the first inflatable balloon 130 and the flexible tubular extension 134 along section line C in FIG. 20. In this proximal portion of the first inflatable balloon 130, the balloon material is wrapped around the flexible tubular extension 134 completely enclosing it. Preferably, the proximal portion of the first inflatable balloon 130 is folded in a two-wing folding configuration as shown, although other folding configurations may also be used. FIG. 21B shows a cross section of the catheter system 100 taken through a transition point intermediate between the proximal and distal portions of the first inflatable balloon 130 along section line B in FIG. 20. At this transition point, the first inflatable balloon 130 makes a transition from the two-wing folding configuration of the proximal portion to the three-wing folding configuration of the distal portion. At this transition point, the distal tip 135 of the flexible extension tube 134 emerges from the folds of the balloon material of the first inflatable balloon 130, as shown in FIG. 20. Optionally, the first inflatable balloon 130 may be heat set in this folded configuration to facilitate mounting a stent on the folded balloon in the next assembly step.
Next, a main vessel stent 170 is mounted over the first inflatable balloon 130 of the first balloon catheter 102 and the flexible tubular extension 134 of the second balloon catheter 104, as shown in FIG. 22, for example by crimping or swaging. The distal tip 135 of the flexible extension tube 134 emerges from the folds of the balloon material of the first inflatable balloon 130 and extends through an open cell or side opening 172 between two struts on the crimped stent 170. This configuration provides a smoother, more consistent surface for crimping the stent onto, which results in a smoother crossing profile for the catheter system 100. Optionally, the first inflatable balloon 130 may be heat set after mounting the main vessel stent 170 onto the first inflatable balloon 130. This provides a smoother surface on the balloon and stent assembly and increases stent retention force, which helps to prevent accidental dislodgement of the stent from the balloon. Optionally, a side branch stent 178 may be mounted on the second inflatable balloon 132 of the second balloon catheter 104, as illustrated in FIG. 5.
In an alternate embodiment of the catheter system 100, the flexible tubular extension 134 may be a distal portion of a single or multiple lumen non-balloon catheter, which is wrapped in the balloon material of the first inflatable balloon 130. In another alternate embodiment of the catheter system 100, the flexible tubular extension 134 may be a sidebranch of the first balloon catheter 102, which is wrapped in the balloon material of the first inflatable balloon 130. The sidebranch of the first balloon catheter 102 may or may not have a second inflatable balloon mounted on it.
Optionally, any of the described embodiments of the catheter system 100 may be provided with a stent with a strut configuration optimized for stenting bifurcations. FIGS. 23-26 illustrate stents 240 configured for stenting bifurcated vessels shown with the unexpanded stent laid out flat to show the strut configuration of the stent 240. Preferably, the stent 240 is fabricated from a seamless metal tube, for example by laser cutting, annealing and electropolishing. In a particularly preferred embodiment, the stent 240 is made from a high-strength biocompatible chromium-cobalt alloy, such as alloy L605 (ASTM F90-01). Alternatively, the stent 240 may be made from other biocompatible metals or alloys, including, but not limited to, 316 stainless steel, Elgiloy or Carpenter MP35. The stent 240 is preferably configured with a multiplicity of struts 250 that are joined together along the length of the stent 240 by links 252 in an open cell configuration. The struts 250 are preferably configured as sinuous or undulating rings extending circumferentially around the stent 240. Each strut 250 has a predetermined number of undulations or cells 254 around the circumference of the stent 240. In the embodiment shown, the cells 254 are shown as simple sinusoidal undulations, however other configurations of cells including open cells and closed cells are also possible.
The stent 240 is divided into a distal area 242, a carina area 244 and a proximal area 246. The strut configuration in each area is preferably optimized for the portion of the vessel in which it will be placed. The number of cells 254 in each strut 250, along with other factors, determines how much the strut 250 will be able to expand circumferentially. In a particularly preferred embodiment, the struts 250 in the carina area 244 will have a greater number of cells 254 than the struts 250 in the distal area 242 and the proximal area 246. Preferably, the struts 250 in the proximal area 246 will also have a greater number of cells 254 than the struts 250 in the distal area 242. This configuration allows the carina area 244 to be expanded more than the distal area 242 and the proximal area 246, and allows the proximal area 246 to be expanded more than the distal area 242. The differential expansion properties of the different areas allow the stent 230 to conform closely to the typical geometry of a bifurcated vessel, where the vessel proximal to the bifurcation typically has a greater diameter than the vessel distal to the bifurcation, and where the vessel in the carina area immediately proximal to the carina of the bifurcation has a diameter greater than the vessels proximal or distal to the bifurcation. This configuration of the stent 240 also allows the crush resistance or hoop strength of the expanded stent to be optimized for each of the areas despite the different stent expansion ratios in each area.
An example of a 3.0 mm (expanded diameter) stent 240 is shown in FIG. 23. The stent 240 is shown with the unexpanded tubular stent laid out flat to show the strut configuration of the stent as it is manufactured and prior to crimping. The stent 240 may be formed, for example, from a seamless tube with nominal dimensions of approximately 1.60 mm diameter, with a wall thickness of approximately 0.11 mm. The stent 240 has six struts 250 in the distal area 242 each having six cells 254 and joined together by two links 252, except for the most distal strut 250, which is joined by three links 252, three struts 250 in the carina area 244 each having eight cells 254 and joined together by four links 252, and five struts 250 in the proximal area 246 each having seven cells 254 and joined together by two links 252, except for the most proximal strut 250, which is joined by three links 252. A single link 252 joins the distal area 242 to the carina area 244, and three links 252 join the proximal area 246 to the carina area 244.
FIGS. 24A, 24B and 24C are detail drawings of three portions of the stent of FIG. 23. FIG. 24A shows one cell 254 of two adjacent struts 250 in the distal area 242 joined by a link 252. FIG. 24B shows one cell 254 of two adjacent struts 250 in the carina area 244 joined by a link 252. FIG. 24C shows one cell 254 of two adjacent struts 250 in the proximal area 246 joined by a link 252. It will be noted that the length of the arms 256 in each cell 254 is slightly longer and more divergent in the distal area 242, of intermediate length and divergence in the proximal area 246 and shortest length and least divergence in the carina area 244 in order to accommodate the different numbers of cells 254 in the struts 250 of these three different areas. Alternatively or in addition, other means may be used to accommodate the different numbers of cells 254 in the struts 250 of the three different areas. For example, the radius of the U-shaped bends 258 that join the arms 256 of the cells 254 together may be varied to accommodate the different numbers of cells 254 around the circumference of the stent 240.
Another example of a 3.5 mm (expanded diameter) stent 240 is shown in FIG. 25. The stent 240 is shown with the unexpanded tubular stent laid out flat to show the strut configuration of the stent as it is manufactured and prior to crimping. The stent 240 may be formed, for example, from a seamless tube with nominal dimensions of approximately 1.60 mm diameter, with a wall thickness of approximately 0.11 mm. The stent 240 has six struts 250 in the distal area 242 each having eight cells 254 and joined together by two links 252, except for the most distal strut 250, which is joined by four links 252, three struts 250 in the carina area 244 each having ten cells 254 and joined together by five links 252, and five struts 250 in the proximal area 246 each having nine cells 254 and joined together by three links 252, except for the most proximal strut 250, which is joined by five links 252. A single link 252 joins the distal area 242 to the carina area 244, and three links 252 join the proximal area 246 to the carina area 244.
FIGS. 26A, 26B and 26C are detail drawings of three portions of the stent of FIG. 25. FIG. 26A shows one cell 254 of two adjacent struts 250 in the distal area 242 joined by a link 252. FIG. 26B shows one cell 254 of two adjacent struts 250 in the carina area 244 joined by a link 252. FIG. 26C shows one cell 254 of two adjacent struts 250 in the proximal area 246 joined by a link 252. Again, it will be noted that the length of the arms 256 in each cell 254 is slightly longer and more divergent in the distal area 242, of intermediate length and divergence in the proximal area 246 and shortest length and least divergence in the carina area 244 in order to accommodate the different numbers of cells 254 in the struts 250 of these three different areas. As mentioned above, other means may also be used to accommodate the different numbers of cells 254 in the struts 250 of the three different areas.
FIGS. 23 and 25 represent only two examples of the many possible configurations for stents made according to the principles of the present invention. For example, the dimensions of the stent, the number and configuration of the struts, cells and links, and other parameters of the stent can be varied greatly, while adhering to the general principles of the stent design that allow it to accommodate the particular geometry of a bifurcated vessel.
FIG. 27 illustrates a two-part stent 300 configured for stenting bifurcated vessels. The two-part stent 300 is shown mounted on a stent delivery catheter 304 in an unexpanded condition. Preferably, the stent delivery catheter 304 is configured with a step balloon 302 having a proximal portion 306 and a distal portion 308 that expand to different diameters. Typically, the proximal portion 306 will have a larger expanded diameter than the distal portion 308, as shown in FIG. 29. However, it should be noted that the proportions of the proximal portion 306 and the distal portion 308 can be reversed, for example for stenting a bifurcated vessel using a retrograde approach rather than a standard antegrade approach. The proximal portion 306 of the step balloon 302 may be cylindrical or conical, as appropriate for the geometry of the bifurcation in the target vessel. FIG. 29 shows an example of a step balloon 302 with a conical proximal portion 306 that increases in diameter from the proximal end of the balloon to the distal end of proximal portion 306 and is largest in diameter adjacent to the step in the balloon.
The two-part stent 300 has a proximal part 310 and a distal part 314 and a non-linked zone 312 between the proximal part 310 and the distal part 314. FIG. 28 is an enlarged detail drawing showing the non-linked zone 312 of the two-part stent 300. The proximal part 310 and the distal part 314 of the two-part stent 300 are typically formed by cutting a metallic tube to form zigzag or undulating stent struts 316. Alternatively, the stent struts 316 can be formed from wire. Optionally, the proximal part 310 and the distal part 314 of the two-part stent 300 can be made with different strut configurations, according to the principles described above, to accommodate expansion to different diameters in the portions of the vessel proximal and distal to the carina region.
In a preferred configuration, the stent struts 316 form circumferential rings that are joined to one another by one or more links similar to the stent embodiments described above. However, there are no links in the non-linked zone 312 between the proximal part 310 and the distal part 314. The absence of links in the non-linked zone 312 allows greater freedom of movement between the proximal part 310 and the distal part 314 of the two-part stent 300. This effectively eliminates any difficulties in alignment of the two parts relative to one another during placement of the two-part stent 300 in a bifurcated vessel.
In one particularly preferred embodiment, the undulations of the stent struts 316 extend like fingers 316, 318 from the distal end of the proximal part 310 and the proximal end of the distal part 314. The fingers 316, 318 interdigitate with one another to create an overlap of the proximal part 310 and the distal part 314 in the non-linked zone 312, as shown in FIG. 28, in order to provide strut coverage in the carina region of the bifurcated vessel equivalent to or greater than a typical one-part stent.
The stent delivery catheter 304 with the two-part stent 300 can be used as a stand-alone catheter for stenting bifurcated vessels. Alternatively, it can be used as the first balloon catheter 102 in a two-catheter stenting system for bifurcated vessels similar to those shown in FIGS. 1-5, 18 and 20-22 for ease and simplicity in performing a kissing-balloon technique. The tandem balloon configurations shown in FIGS. 5, 18 and 20-22 would provide the additional benefit of a lower crossing profile, as compared to the side-by-side balloon configurations shown in FIGS. 1-4. (or two-catheter system)
When used as a stand-alone catheter, the stent delivery catheter 304 with the step balloon 302 and the two-part stent 300 allow simple stenting of a bifurcation using a provisional stenting technique. The stent delivery catheter 304 is introduced into the patient's vascular system and navigated with the aid of a guidewire to the vessel bifurcation to be stented. The step balloon 302 is maneuvered so that the non-linked zone 312 of the two-part stent 300 is positioned at the carina region of the bifurcation just proximal to the takeoff of the sidebranch vessel. Optionally, a second guidewire (not shown) may be introduced into the sidebranch vessel to maintain access to the sidebranch vessel using the “jailed wire” technique. The step balloon 302 is inflated with fluid to expand the two-part stent 300. FIG. 30 shows the two-part stent 300 of FIG. 27 expanded in a bifurcated vessel. The proximal portion 306 of the step balloon 302 expands the proximal part 310 of the two-part stent 300 to larger diameter appropriate to the size of the vessel proximal to the bifurcation, and the distal portion 308 of the step balloon 302 expands the distal part 314 of the two-part stent 300 to smaller diameter appropriate to the size of the vessel distal to the bifurcation. It may be preferable to overdilate the vessel slightly, as shown in FIG. 30, because there will be some elastic recovery of the vessel wall and the stent 300 when the balloon 302 is deflated. After deflating and withdrawing the step balloon 302 the proximal part 310 of the two-part stent 300 will shift into the ostium of the side branch 304 creating an access to the side branch 304. FIG. 31 shows the bifurcated vessel after stenting with the two-part stent 300 of FIG. 27.
According to the provisional stenting technique, the procedure may be terminated with a kissing balloon inflation and/or by deploying a stent within the sidebranch vessel. A third guidewire is now crossed from within the proximal part 310 of the two-part stent 300 through the non-linked zone 312 at the distal end of the proximal part 310 of the two-part stent 300 into the lumen of the sidebranch vessel. The edges of the expanded stent are designed to facilitate guidewire crossing. After withdrawing the jailed wire, the procedure can be completed with classical kissing balloons technique.
Any one of the various embodiments of the catheter system for stenting bifurcated vessels described herein can be combined with drug eluting technology to prevent restenosis, inflammation and/or thrombosis and/or to promote reendothelialization in the vessel bifurcation that is being treated. For example, the main vessel stent 170 and/or the optional sidebranch stent 178 may be coated or impregnated with one or more drugs or bioactive substances to prevent restenosis, inflammation and/or thrombosis and/or to promote reendothelialization. Suitable drugs or bioactive substances include, but are not limited to, Paclitaxel, Everolimus, Zotarolimus, Sirolimus, Tacrolimus, Biolimus A9, Heparin, Anti-hCD34 Antibody, imatinib mesylate and biomimetic surface coatings, or combinations thereof. The stent(s) can be treated with a polymer, ceramic and/or biological coating into which the drugs or bioactive substances can be absorbed, impregnated or otherwise applied. The coating can be biostable, biodegradable, bioerodable, or combinations thereof. Alternatively, one or more drugs or bioactive substances can be applied directly to the stent surface without an intermediate surface coating.
Alternatively or in addition, the first balloon 130 and/or the second balloon 132 may be coated with or include a mechanism for delivering one or more drugs or bioactive substances to prevent restenosis, inflammation or thrombosis and/or to promote reendothelialization. Suitable drugs or bioactive substances include, but are not limited to, Paclitaxel, Everolimus, Zotarolimus, Sirolimus, Tacrolimus, Biolimus A9, Heparin, Anti-hCD34 Antibody, imatinib mesylate and biomimetic surface coatings, or combinations thereof. The balloon(s) can be treated with a polymer or nonpolymer coating into which the drugs or bioactive substances can be absorbed, impregnated or otherwise applied. Alternatively, one or more drugs or bioactive substances can be applied directly to the balloon surface without an intermediate surface coating. As another alternative, the first balloon 130 and/or the second balloon 132 may include a mechanism for delivering one or more drugs or bioactive substances onto the surface and/or into the wall of the vessel being treated. Possible drug delivery mechanisms include porous balloons, drug infusion balloons and drug infusion sleeves. Examples of suitable drug delivery mechanisms are described in U.S. Pat. Nos. 6,030,362, 5,941,868, 5,876,374, 5,855,563, 5,810,869, 5,810,767, 5,772,629, 5,713,860, 5,634,901, 5,609,574, 5,599,306, 5,571,086, 5,336,178, 5,279,565.
Drug eluting or coated stents and drug delivery balloons may be combined in various configurations in the catheter system. In one exemplary embodiment that is envisioned for use in provisional stenting procedures, the catheter system is configured to deliver a main vessel stent 170, which is treated with a drug eluting coating or the like, into the main vessel of the bifurcation and the second balloon 132 is coated with or otherwise includes a mechanism for delivering one or more drugs or bioactive substances to the sidebranch of the bifurcation. This configuration provides a complete treatment of the bifurcation area while allowing the clinician the option of whether or not to place a sidebranch stent in the sidebranch vessel after evaluating the results of the primary stenting procedure (i.e. provisional stenting). The optional sidebranch stent can be delivered on a separate balloon catheter and may be a drug-eluting or a noncoated (e.g. bare metal) stent.
Drug eluting or coated stents and drug delivery balloons may also be used in combination to provide a synergistic effect of two different drugs or bioactive substances. For example, one substance may be applied by a drug delivery balloon to provide a short term or acute effect, while another substance may be applied using a drug eluting or coated stent for long term chronic effect. An example of such a combination would be to apply an anti-inflammatory drug to the arterial wall with a drug delivery balloon to prevent inflammation and therefore avoid a cellular hyperproliferation reaction in the vessel wall during the acute phase immediately after treatment and also to coat the stent(s) with a biomimetic coating to prevent a foreign body reaction to the stent material and to encourage reendothelialization.
a first balloon catheter having a shaft with a proximal end and a distal end and a first inflatable balloon mounted on the shaft proximate to the distal end;
a second balloon catheter having a shaft with a proximal end and a distal end, and a second inflatable balloon mounted on the shaft proximate to the distal end;
a linking device attachable near the proximal ends of the catheters for releasably linking the first catheter and the second catheter together in a side-by-side configuration; and
a stent mounted on the first inflatable balloon;
wherein at least one of the first balloon or the second balloon is configured to deliver a drug or bioactive substance to a vessel wall.
2. The catheter system of claim 1, wherein the first inflatable balloon is configured to deliver the drug or bioactive substance to the vessel wall.
3. The catheter system of claim 1, wherein the second inflatable balloon is configured to deliver the drug or bioactive substance to the vessel wall.
4. The catheter system of claim 1, wherein the first and second inflatable balloons are configured to deliver the drug or bioactive substance to the vessel wall.
5. The catheter system of claims 1 through 4, wherein the stent is configured to deliver a drug or bioactive substance to the vessel wall.
6. The catheter system of claims 1 through 5, further comprising a second stent mounted on the second inflatable balloon.
7. The catheter system of claim 6, wherein the second stent is configured to deliver a drug or bioactive substance to the vessel wall.
8. The catheter system of any of the previous claims, incorporating the drug Paclitaxel.
US11789001 2003-10-16 2007-04-23 Catheter system for stenting and drug treatment of bifurcated vessels Active 2029-06-13 US9278015B2 (en)
US51225903 true 2003-10-16 2003-10-16
US53446904 true 2004-01-05 2004-01-05
US10833494 US7641684B2 (en) 2003-10-16 2004-04-27 Catheter system for stenting bifurcated vessels
US11107393 US7695508B2 (en) 2003-10-16 2005-04-15 Catheter system for stenting bifurcated vessels
US11319767 US7713296B2 (en) 2003-10-16 2005-12-27 Catheter system for stenting bifurcated vessels
US11789001 US9278015B2 (en) 2003-10-16 2007-04-23 Catheter system for stenting and drug treatment of bifurcated vessels
US11319767 Continuation-In-Part US7713296B2 (en) 2003-10-16 2005-12-27 Catheter system for stenting bifurcated vessels
US20070282419A1 true true US20070282419A1 (en) 2007-12-06
US9278015B2 US9278015B2 (en) 2016-03-08
ID=38791314
US11789001 Active 2029-06-13 US9278015B2 (en) 2003-10-16 2007-04-23 Catheter system for stenting and drug treatment of bifurcated vessels
US (1) US9278015B2 (en)
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Owner name: MINVASYS, FRANCE
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:HILAIRE, PIERRE;VAN DER LEEST, MACHIEL;REEL/FRAME:019794/0214