WO2025071608A1

WO2025071608A1 - Embolization devices

Info

Publication number: WO2025071608A1
Application number: PCT/US2023/075371
Authority: WO
Inventors: Danielle ELDRED; Keith S. Harris; Hannah HORECZKO; Sanya Vipul MEHTA; Gabriella Romano
Original assignee: Bard Peripheral Vascular Inc
Current assignee: Bard Peripheral Vascular Inc
Priority date: 2023-09-28
Filing date: 2023-09-28
Publication date: 2025-04-03
Anticipated expiration: 2026-03-28

Abstract

An embolization device includes a catheter having a guidewire lumen, a proximal balloon inflation lumen, and a distal balloon inflation lumen. A proximal balloon is disposed on the catheter and is in fluid communication with the proximal balloon inflation lumen, and a distal balloon is disposed on the catheter and is in fluid communication with the distal balloon inflation lumen. A stent having a proximal stent portion, a distal stent portion, and a stent neck disposed is therebetween, the proximal stent portion being disposed over the proximal balloon and the distal stent portion being disposed over the distal balloon. The proximal balloon and the distal balloon are inflated independently via the proximal balloon inflation lumen and the distal balloon inflation lumen such that. The proximal balloon is inflated to a first diameter and the distal balloon is inflated to a second diameter.

Description

EMBOLIZATION DEVICES

TECHNICAL FIELD

[0001] The present disclosure relates to embolization devices and methods, and, more particularly, to embolization devices having independently expandable balloon members.

BACKGROUND

[0002] Conventional embolization devices typically consist of catheters with integrated balloons and/or coils. These devices are deployed within a target area, such as a blood vessel, and are used to occlude the vessel by inflating the balloon and/or deploying the coils. However, existing embolization devices often lack independent control over the inflation and deflation of individual occlusion elements. For example, in some cases, single balloons are utilized to obstruct vessels, which can result in uniform occlusion that may be unsuitable for certain applications. Additionally, the lack of adaptability and customization limits the effectiveness and versatility of conventional embolization procedures. Accordingly, a need exists for an embolization device that provides improved control, precision, and adaptability in vessel occlusion procedures.

SUMMARY

[0003] An object of the present disclosure is to provide an embolization device that includes a plurality of independently inflatable balloon members that allow for the embolization device to occlude asymmetrical regions within a target site.

[0004] In one embodiment, an embolization device is disclosed. The embolization device includes a catheter including a guidewire lumen, a proximal balloon inflation lumen, and a distal balloon inflation lumen. The guidewire lumen, the proximal balloon inflation lumen, and the distal balloon inflation lumen are spaced from one another. The embolization device further includes a proximal balloon disposed on the catheter, the proximal balloon in fluid communication with the proximal balloon inflation lumen, a distal balloon distally spaced apart from the proximal balloon and disposed on the catheter, the distal balloon in fluid communication with the distal balloon inflation lumen, and a stent having a proximal stent portion, a distal stent portion, and a stent neck disposed therebetween, the proximal stent portion disposed over the proximal balloon and the distal stent portion disposed over the distal balloon. The proximal balloon and the distal balloon are configured to be inflated independently via, respectively, the proximal balloon inflation lumen and the distal balloon inflation lumen such that, when inflated, the proximal balloon is inflated via the proximal balloon inflation lumen to a first diameter such that the proximal stent portion expands to the first diameter and the distal balloon is inflated via the distal balloon inflation lumen to a second diameter such that the distal stent portion expands to the second diameter.

[0005] In another embodiment, an embolization device is disclosed. The embolization device includes a catheter having a proximal end and a distal end, a guidewire lumen extending from the proximal end to the distal end of the catheter, a proximal balloon inflation lumen extending at least a portion from the proximal end to the distal end of the catheter, and a distal balloon inflation lumen extending at least a portion from the proximal end to the distal end of the catheter. The guidewire lumen, the proximal balloon inflation lumen, and the distal balloon inflation lumen are spaced from one another. The embolization device further includes a proximal balloon disposed on the catheter, the proximal balloon in fluid communication with the proximal balloon inflation lumen, a distal balloon disposed on the catheter, the distal balloon in fluid communication with the distal balloon inflation lumen, and a stent having a proximal stent portion disposed over the proximal balloon and a distal stent portion disposed over the distal balloon. The proximal balloon and the distal balloon are configured to be inflated independently via, respectively, the proximal balloon inflation lumen and the distal balloon inflation lumen such that, when inflated, the proximal balloon is inflated via the proximal balloon inflation lumen to a first diameter such that the proximal stent portion expands to the first diameter and the distal balloon is inflated via the distal balloon inflation lumen to a second diameter such that the distal stent portion expands to the second diameter.

[0006] In yet another embodiment, a method of embolizing a target area is disclosed. The method includes inserting a distal end of a catheter of an embolization device into the target area, the catheter having a guidewire lumen, a proximal balloon inflation lumen, and a distal balloon inflation lumen spaced from one another, the embolization device further including a proximal balloon disposed on the catheter and in fluid communication with the proximal balloon inflation lumen, a distal balloon disposed on the catheter and in fluid communication with the distal balloon inflation lumen, and a stent having a proximal stent portion, a distal stent portion, and a stent neck disposed therebetween, the proximal stent portion disposed over the proximal balloon and the distal stent portion disposed over the distal balloon; inflating the proximal balloon via the proximal balloon inflation lumen of the catheter to a first diameter in the target area to expand the proximal stent portion to the first diameter; and independently inflating the distal balloon via the distal balloon inflation lumen of the catheter to a second diameter in the target area to expand the distal stent portion to the second diameter.

[0007] These and additional features provided by the embodiments described herein will be more fully understood in view of the following detailed description, in conjunction with the drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0008] The embodiments set forth in the drawings are illustrative and exemplary in nature and not intended to limit the subject matter defined by the claims. The following detailed description of the illustrative embodiments can be understood when read in conjunction with the following drawings, where like structure is indicated with like reference numerals and in which:

[0009] FIG. 1 depicts a perspective view of an embolization device, according to one or more embodiments shown and described herein;

[0010] FIG. 2 depicts a longitudinal cross-sectional view of the embolization device of FIG. 1, according to one or more embodiments shown and described herein;

[0011] FIG. 3 depicts an axial cross-sectional view of the embolization device of FIG. 1, according to one or more embodiments shown and described herein;

[0012] FIG. 4A depicts a longitudinal side view of the embolization device of FIG. 1 in a deflated state, according to one or more embodiments shown and described herein;

[0013] FIG. 4B depicts a longitudinal side view of the embolization device of FIG. 4 A in an inflated state, according to one or more embodiments shown and described herein;

[0014] FIG. 5 depicts a perspective view of another embodiment of an embolization device, according to one or more embodiment shown and described herein;

[0015] FIG. 6 depicts a schematic view of a controller for operating an embolization device, according to one or more embodiments shown and described herein; and

[0016] FIG. 7 depicts a flow diagram of an illustrative method of embolizing a target area using an embolization device, according to one or more embodiments shown and described herein. [0017] Reference characters indicate corresponding parts throughout the several views. The exemplifications set out herein illustrate at least one embodiment of the present disclosure, and such exemplifications are not to be construed as limiting the scope of the present disclosure in any manner.

DETAILED DESCRIPTION

[0018] Embodiments disclosed herein relate to embolization devices and methods of embolizing target areas. For example, in embodiments, an embolization device includes a catheter defining a guidewire lumen, a proximal balloon lumen, and a distal balloon lumen. A proximal balloon may be disposed about the catheter and fluidly coupled to the proximal balloon lumen, and a distal balloon may be disposed about the catheter and fluidly coupled to the distal balloon lumen, such that the proximal balloon and the distal balloon are spaced apart from one another in a longitudinal direction. The embolization device may further include a stent including a proximal stent portion disposed about the proximal balloon, a distal stent portion disposed about the distal balloon, and a stent neck that extends between the proximal stent portion and the distal stent portion. The proximal balloon and the distal balloon may be configured to be independently actuated, such that, when inflated, the proximal balloon has a first diameter and the distal balloon has a second diameter, with the second diameter being different from the first diameter.

[0019] As should be appreciated, embolization techniques have been widely employed in the medical field to treat various conditions such as tumors, vascular malformations, aneurysms, and excessive bleeding. These techniques typically involve the intentional obstruction of a target area, such as a blood vessel, often using embolic materials to limit and/or eliminate blood flow to specific areas within a vessel. However, conventional embolization devices lack independent control over the inflation and deflation of occlusion elements (e.g., balloons, coils, etc.), which can limit the effectiveness of the devices and the various circumstances under which they may be utilized.

[0020] The embolization device of the present disclosure aims to address a number of the shortcomings of conventional embolization devices by incorporating a catheter with distinct lumens, such that the embolization device may have precise control over each of the occlusion elements utilized in the device. For example, the embolization device may be configured to independently inflate and deflate the proximal and distal balloons to allow for precise positioning and targeted occlusion within a vessel. Furthermore, the selective inflation of the proximal and distal balloons may allow for customization of treatment based on vessel size, shape, and other anatomical considerations.

[0021] Embodiments of embolization devices and methods of embolizing target areas will now be described in more detail herein with reference to the drawings and where like numbers refer to like structures.

[0022] Referring now to FIGS. 1-3, an embolization device 10 is depicted. The embolization device 10 may include a catheter 100 that extends from a proximal end 102 to a distal end 104. As most clearly depicted in FIGS. 2 and 3, the catheter 100 may further include or define a guidewire lumen 106, a proximal balloon inflation lumen 108, and a distal balloon inflation lumen 109. In these embodiments, the guidewire lumen 106 may extend through the catheter 100 (e.g., from the proximal end 102 to the distal end 104), such that a guidewire may be passed through the guidewire lumen 106 and used to position the embolization device 10 within a vessel. Furthermore, the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109 may extend along at least a portion of the catheter 100 from the proximal end 102 to the distal end 104, as will be described in additional detail herein. The catheter 100 may be formed of any suitable material for advancing within a vessel of a subject such as silicone, PVC, polyethylene, polyurethane, PET, nylon, Pebax, etc.

[0023] As further depicted in FIGS. 2 and 3, the guidewire lumen 106 may be centrally positioned within the catheter 100, and the guidewire lumen 106, the proximal balloon inflation lumen 108, and the distal balloon inflation lumen 109 may be spaced apart from one another. For example, the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109 may be spaced apart from the guidewire lumen 106 in any axial direction (e.g, in the +/- y-direction, +/- z-direction as depicted in the coordinate axes of FIGS. 2 and 3). In embodiments, the proximal balloon inflation lumen 108, the distal balloon inflation lumen 109, and the guidewire lumen 106 may extend alongside one another (such as parallel to one another) while terminating at varying positions. For example, the guidewire lumen 106 may extend through the distal end 104 of the catheter 100, the distal balloon inflation lumen 109 may terminate proximal to the distal end 104 of the catheter 100, and the proximal balloon inflation lumen 108 may terminate proximal to the position of termination of the distal balloon inflation lumen 109 and the distal end 104. It should be appreciated that, in these embodiments, the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109 may be formed at any position within the circumference of the catheter 100 so long as space remains between each of the guidewire lumen 106, the proximal balloon inflation lumen 108, and the distal balloon inflation lumen 109.

[0024] Referring again to FIGS. 1-3, the embolization device 10 may further include a plurality of balloons, such as a proximal balloon 120 and a distal balloon 140, that may be disposed on the distal end 104 of the catheter 100, and may be spaced apart from one another in a longitudinal direction (e.g., in the +/- x-direction as depicted in the coordinate axes of FIGS. 1-3). Although the embolization device 10 depicted in FIGS. 1 and 2 is illustrated as including two balloons (e.g., proximal balloon 120 and distal balloon 140), it should be appreciated that the embolization device 10 may include any number of balloons without departing from the scope of the present disclosure.

[0025] In these embodiments and with reference to FIG. 2, the proximal balloon 120 may include a pair of outer ends, such as a first outer end 120a (e.g., the end of the proximal balloon 120 positioned towards the proximal end 102 of the catheter 100) and a second outer end 120b (e.g. the end of the proximal balloon 120 positioned towards the distal end 104 of the catheter 100), and a proximal balloon length Lp that extends between the first outer end 120a and the second outer end 120b of the proximal balloon. Similarly, the distal balloon 140 may include a pair of outer ends, such as a first outer end 140a (e.g., the end of the distal balloon 140 positioned towards the distal end 104 of the catheter 100) and a second outer end 140b (e.g., the end of the distal balloon 140 positioned towards the proximal end 102 of the catheter 100), and a distal balloon length Ld that extends between the first outer end 140a and the second outer end 140b of the distal balloon. In some embodiments, the proximal balloon length Lp may be equal to the distal balloon length Ld, while in other embodiments, the proximal balloon length Lp may be different (e.g., longer or shorter) than the distal balloon length Ld.

[0026] As most clearly depicted in FIG. 2, the proximal balloon 120 may be fluidly coupled to the proximal balloon inflation lumen 108, such that fluid may be transferred through the proximal balloon inflation lumen 108 and into the proximal balloon 120 to inflate the proximal balloon 120. Similarly, the distal balloon 140 may be fluidly coupled to the distal balloon inflation lumen 109, such that fluid may be transferred through the distal balloon inflation lumen 109 and into the distal balloon 140 to inflate the distal balloon 140. In these embodiments, the plurality of balloons may be formed from nylon, polyethylene terephthalate (“PET”) or any other similarly expandable material. Inflation of the proximal balloon 120 and distal balloon 140, respectively, will be described in additional detail herein with reference to FIGS. 4 A and 4B.

[0027] Referring again to FIGS. 1-3, the embolization device 10 may further include a plurality of fluid sources, such as a first fluid source 110 and second fluid source 112, which may be configured to inflate the proximal and distal balloons 120, 140, respectively. For example, as depicted most clearly in FIGS. 1 and 2, the first fluid source 110 may be fluidly coupled to the proximal balloon 120 via the proximal balloon inflation lumen 108, while the second fluid source 112 may be fluidly coupled to the distal balloon 140 via the distal balloon inflation lumen 109. In these embodiments, the first and second fluid sources 110, 112 may provide saline, or any other suitable inflation fluid, through the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109 in order to inflate the proximal balloon 120 and the distal balloon 140, respectively. Furthermore, it should be appreciated that because the proximal balloon 120 and the distal balloon 140 include separate inflation lumens and separate fluid sources, the proximal balloon 120 and the distal balloon 140 may be inflated independently of one another, as will be described in additional detail herein.

[0028] In these embodiments, it should be further noted that the plurality of fluid sources may be operated either manually or via a control system. For example, in some embodiments, each of the plurality of fluid sources may be manually operated to provide a desired volume of fluid to each of the proximal balloon 120 and the distal balloon 140. In other embodiments, each of the plurality of fluid sources may be connected to a controller (e.g., controller 600 as depicted in FIG. 6), which may be used to electronically and/or automatically control the delivery of fluid to each of the proximal balloon 120 and the distal balloon 140.

[0029] Furthermore, it should be appreciated that the embolization device 10 may include any number of fluid sources without departing from the scope of the present disclosure. For example, in some embodiments, the number of the plurality of fluid sources may correspond to the number of the plurality of balloons disposed on the catheter 100, such that each of the plurality of balloons is fluidly coupled to and actuated by a single fluid source. However, in other embodiments, a single fluid source may be fluidly coupled to and used to actuate multiple balloons, such that the number of the plurality of balloons is different (e.g., greater than) the number of the plurality of fluid sources. In these embodiments it should be appreciated that the plurality of fluid sources may include syringes, fluid reservoirs, infuser pumps, manifolds, or any other similar device capable of deliver fluid to the plurality of balloons. Additional embodiments of the embolization device 10 that utilize a single fluid source to operate multiple balloons will be described in additional detail herein with reference to FIG. 5.

[0030] Referring again to FIGS. 1-3, the embolization device 10 may further include a stent 160 disposed on at least a portion of the proximal balloon 120 and/or distal balloon 140. In these embodiments, the stent 160 may further include a proximal stent portion 162, a distal stent portion 164, and a stent neck 166 disposed between the proximal stent portion 162 and the distal stent portion 164.

[0031] As further depicted in FIGS. 1-3, the proximal stent portion 162 may be disposed about the proximal balloon 120, while the distal stent portion 164 may be disposed about the distal balloon 140. Furthermore, the stent neck 166 may be disposed about the catheter 100 and occupy the space (e.g., in the longitudinal direction) between the proximal balloon 120 and the distal balloon 140. For example the stent neck 166 may include a proximal neck end 166a and a distal neck end 166b, with the proximal neck end 166a being positioned towards the proximal end 102 of the catheter 100 and the distal neck end 166b being positioned towards the distal end 104 of the catheter 100. As most clearly depicted in FIG. 2, the proximal balloon 120 may be positioned proximally (e.g., in the + x-direction as depicted in the coordinate axis of FIG. 2) past the proximal neck end 166a of the stent neck 166, while the distal balloon 140 may be positioned distally (e.g., in the - x-direction as depicted in the coordinate axis of FIG. 2) past the distal neck end 166b of the stent neck 166. In these embodiments, the proximal neck end 166a of the stent neck 166 may be adjacent the first outer end 120a of the proximal balloon 120, and the distal neck end 166b may be adjacent the second outer end 140b of the distal balloon 140, such that the stent neck 166 has a length Ls (e.g., from the proximal neck end 166a to the distal neck end 166b in the +/- x-direction as depicted in the coordinate axis of FIG. 2) that is equivalent to the space (e.g., in the longitudinal direction) between the proximal balloon 120 and the distal balloon 140.

[0032] Referring still to FIGS. 1-3, the proximal stent portion 162 may fully surround a circumference of the proximal balloon 120, while the distal stent portion 164 may fully surround a circumference of the distal balloon 140. Furthermore, the proximal stent portion 162 may have a length Lps that is equal to the length of the proximal balloon 120, such that the proximal stent portion 162 encompasses the proximal balloon 120. Similarly, in some embodiments, the distal stent portion 164 may have a length Lds that is equal to the length of the distal balloon 140, such that the distal stent portion 164 encompasses the distal balloon 140. In these embodiments, the total length Lts of the stent 160 (e.g, the combined length of the proximal stent portion 162, the distal stent portion 164, and the stent neck 166) may be equal to a combined length between the outer ends of the proximal balloon 120 and the distal balloon 140 (e.g., the length between the first outer end 120a of the proximal balloon and the first outer end 140a of the distal balloon 140). However, it should be appreciated that, in embodiments, the proximal stent portion 162 and the distal stent portion 164 may each have a length that is shorter than the length Lp, Ld of the proximal and distal balloons 120, 140, respectively, such that the total length Lts of the stent 160 is less than the combined length between the outer ends of the proximal balloon 120 and the distal balloon 140.

[0033] Referring still to FIGS. 1-3, the proximal stent portion 162 and the distal stent portion 164 may be formed of an expandable material, such as plytetrafluroethylene or any other similar material, while the stent neck 166 is formed of a rigid material, such as bare metal stainless steel, cobalt chromium, or any other similar material. Accordingly, as depicted most clearly in FIGS. 1 and 2, the proximal stent portion 162 and the distal stent portion 164 may be expanded by inflation of the proximal and/or distal balloon 120, 140, respectively, while the region of the catheter 100 occupied by the stent neck 166 remains unexpanded. In these embodiments, expansion of the proximal stent portion 162 and the distal stent portion 164, respectively, may give the stent 160 an hourglass-shaped profile when the stent 160 is expanded. Expansion of the proximal and distal balloons 120, 140 and stent 160 will be described in additional detail herein with reference to FIGS. 4 A and 4B.

[0034] Referring still to FIGS. 1-3, the embolization device may further include a plurality of bands, such as radiopaque bands, that may be positioned about the proximal balloon 120, the distal balloon 140, and/or the stent 160. For example, as depicted most clearly in FIG. 2, the embolization device 10 may include a proximal balloon band 180a, a distal balloon band 180b, and a stent balloon band 180c. In these embodiments, the radiopaque bands 180 may aid a user in positioning the embolization device 10 within a vessel and determine when the proximal balloon 120 and/or distal balloon 140 have been inflated to a maximum diameter. For example, in the embodiments described herein, the radiopaque bands 180 may be visible using fluoroscopy or any other similar imaging method, such that a user can determine the positioning of the embolization device 10 within the vessel. With the embolization device 10 positioned, the proximal balloon 120 and the distal balloon 140 may be inflated using a radiopaque fluid, for example, that may allow a user to visualize when each of the proximal balloon 120 and the distal balloon 140 have been inflated to a maximum diameter. Although the embolization device described herein may utilize both the radiopaque bands 180 and radiopaque fluid, it should be appreciated that, in some embodiments, the embolization device 10 may utilize only one of the radiopaque bands 180 or the radiopaque fluid to position the embolization device within the vessel.

[0035] Turning now to FIGS. 4A and 4B, the proximal balloon 120 and distal balloon 140 are depicted in a deflated state and an inflated state, respectively. For example, FIG. 4A depicts both the proximal balloon 120 and the distal balloon 140 devoid or substantial devoid of inflation fluid, which may correspond to the proximal balloon 120 and the distal balloon 140 being in the deflated state. In these embodiments, the proximal balloon 120 may include a deflated proximal balloon diameter Dpd and the distal balloon 140 may include a deflated distal balloon diameter Ddd.

[0036] As further depicted in FIG. 4A, with the proximal balloon 120 and the distal balloon 140 in the deflated state, the stent 160 may be unexpanded. That is, the proximal stent portion 162 and the distal stent portion 164 may each be unexpanded, such that the proximal stent portion 162 and the distal stent portion 164 lie flush or in closer radial proximity with the proximal balloon 120 and the distal balloon 140, respectively, as opposed to an inflated state. With the proximal balloon 120 and the distal balloon 140 actuated to the deflated state, the embolization device 10 may be positioned within the vessel at a desired location. That is, the low radial profile of the deflated state, may be better suited for traversing the catheter 100 through a vessel to a desired location.

[0037] Referring now to FIG. 4B, once the embolization device 10 is positioned at the desired location for occlusion, the proximal balloon 120 and/or distal balloon 140 may be inflated via the fluid sources and inflation lumens, as has been described herein. In particular, the proximal balloon 120 may be inflated to a first diameter (e.g., a proximal balloon inflated diameter Dpi) while the distal balloon 140 may be inflated to a second diameter (e.g., a distal balloon inflated diameter Ddi).

[0038] In these embodiments, the proximal balloon inflated diameter Dpi may be equivalent to the distal balloon inflated diameter Ddi, such that the proximal balloon 120 and the distal balloon 140 are the same size and/or volume when the proximal balloon 120 and the distal balloon 140 are in the inflated state. However, it some embodiments, the proximal balloon inflated diameter Dpi may be different than the distal balloon inflated diameter Ddi. For example, FIG. 4B depicts the proximal balloon 120 as having a larger proximal balloon inflated diameter Dpi than the distal balloon inflated diameter Ddi of the distal balloon 140. In these embodiments, utilizing a proximal balloon 120 and distal balloon 140 that have different inflated diameters may be particularly beneficial for treating asymmetrical regions of occlusions that may be located within a vessel. That is, the proximal balloon 120 and the distal balloon 140 may be inflated appropriately based on the vessel diameter at their specific positions to ensure proper occlusion without overstraining the vessel, for example.

[0039] Referring still to FIG. 4B, expansion of the proximal balloon 120 and the distal balloon 140, respectively, may result in expansion of the stent 160. For example, as the proximal balloon 120 expands to the proximal balloon inflated diameter Dpi, the proximal stent portion 162 may expand to an equivalent diameter. Similarly, as the distal balloon 140 expands, the distal stent portion 164 may also expand to an equivalent diameter. In these embodiments, the stent 160 may further include a plurality of coils, such as embolic coils, or any other similar device capable of reducing blood flow in and/or occluding a vessel.

[0040] In the embodiments described herein, it should be appreciated that the proximal balloon 120 and the distal balloon 140 may be inflated independently of one another. For example, the proximal balloon 120 may be inflated to the proximal balloon inflated diameter Dpi first, after which the distal balloon 140 may be inflated to the distal balloon inflated diameter Ddi. However, in some embodiments, the proximal balloon 120 and the distal balloon 140 may be inflated simultaneously.

[0041] Furthermore, in the embodiment depicted in FIG. 4B, it should be appreciated that the proximal balloon inflated diameter Dpi and the distal balloon inflated diameter Ddi may correspond to the maximum diameter to which the proximal balloon 120 and the distal balloon 140 may be inflated. For example, in these embodiments, a user may determine the size of the vessel and the size of an occlusion positioned within the vessel prior to conducting an embolization procedure. Once the size of the occlusion and the vessel have been determined, a user may select a proximal balloon 120 and a distal balloon 140 to be used as part of the embolization device 10. In these embodiments, a user may select a proximal balloon 120 and a distal balloon 140 that each have a maximum diameter that is equivalent to the diameter of the vessel. Accordingly, it may be possible to ensure that the proximal balloon 120 and the distal balloon 140 (and in turn, the stent 160) contact the vessel by simply inflating each of the proximal balloon 120 and the distal balloon 140 to their respective maximum diameters.

[0042] Referring now to FIG. 5, another embodiment of an embolization device 10' is depicted. It should be appreciated that the embolization device 10' is similar to the embolization device 10 described herein. As such, like structure is indicated with like reference numerals.

[0043] In the embodiment depicted in FIG. 5, the embolization device 10' may include a single fluid source, such as first fluid source 110. In these embodiments, the first fluid source 110 may be fluidly coupled to both the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109, such that the first fluid source 110 may deliver fluid to inflate the proximal balloon 120 and the distal balloon 140, respectively.

[0044] As further depicted in FIG. 5, the embolization device 10' may further include a valve 116, such as a y-valve, that may include a plurality of ports for coupling to the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109. For example, the valve 116 may include a first port 116a that is fluidly coupled to the proximal balloon inflation lumen 108, and a second port 116b that is fluidly coupled to the distal balloon inflation lumen 109. In these embodiments, the first port 116a and the second port 116b may be selectively opened and closed (e.g., manually or via a controller) in order to allow the first fluid source 110 to provide fluid to the proximal balloon inflation lumen 108 and the distal balloon inflation lumen 109 independently. For example, in embodiments, the first port 116a may be moved to an open position while the second port 116b is moved to a closed position. The first fluid source 110 may provide fluid via the first port 116a to the proximal balloon inflation lumen 108 in order to independently inflate the proximal balloon 120 to a desired volume. Once the proximal balloon 120 is inflated, the first port 116a may be moved to the closed position, while the second port 116b is moved to the open position. At this point, the first fluid source 110 may provide fluid via the second port 116b to the distal balloon inflation lumen 109 in order to independently inflate the distal balloon 140 to a desired volume.

[0045] Referring now to FIG. 6, it has been described herein that, in some embodiments, a controller 600 may be utilized to control the plurality of fluid sources and/or the volume of fluid supplied to the proximal balloon 120 and the distal balloon 140, respectively. Accordingly, FIG. 6 depicts a schematic view of a controller 600 for operating the disclosed embolization device 10. In these embodiments, the controller 600 may be configured to control the volume of fluid supplied from the first fluid source 110 to the proximal balloon 120 and the volume of fluid supplied from the second fluid source 112 to the distal balloon 140.

[0046] To operate the embolization device 10, the controller 600 may include a controller circuit 618, a proximal balloon activation source 620, and a distal balloon activation source 622. The controller 600 may further include a control input 628, such as a computer, which may allow a user to operate the controller 600. In these embodiments, the control input 628 may be configured to provide automatic control of the controller 600 via a software program, or may be manually controlled via a user manipulating a user interface thereof.

[0047] Referring still to FIG. 6, the control input 628 may include a user interface (e.g., control buttons and visual/aural indicators, such as a display and/or speakers, with the control buttons providing user control over various functions of the controller 600, and with the visual/aural indicators providing visual/aural feedback of the status of one or more conditions and/or positions of components of the controller 600). The control buttons may include one or more buttons and/or knobs 628a-628d for supplying fluid to the proximal balloon 120 and/or the distal balloon 140.

[0048] Controller circuit 618 is electrically and communicatively coupled to proximal balloon activation source 620, distal balloon activation source 622, and control input 628, such as by one or more wires or circuit traces. Controller circuit 618 may be assembled on an electrical circuit and may include, for example, a processor circuit 618a and a memory circuit 618b.

[0049] Processor circuit 618a has one or more programmable microprocessors and associated circuitry, such as an input/output interface, buffers, memory, etc. Memory circuit 618b is communicatively coupled to processor circuit 618a, e.g., via a bus circuit, and is a non-transitory electronic memory that may include volatile memory circuits, such as random access memory (RAM), and non-volatile memory circuits, such as read only memory (ROM), electronically erasable programmable ROM (EEPROM), flash memory, etc. Controller circuit 618 may be formed as one or more Application Specific Integrated Circuits (ASIC).

[0050] Controller circuit 618 is configured via software and/or firmware residing in memory circuit 618b to execute program instructions to perform functions associated with the embolization device 10. For example, the controller circuit 618 may activate either the proximal balloon activation source 620 and/or the distal balloon activation source 622 to provide fluid to the proximal balloon 120 and/or the distal balloon 140.

[0051] Referring still to FIG. 6, the proximal balloon activation source 620 may include, for example, a proximal balloon module 630 configured to control inflation of the proximal balloon 120. In these embodiments, the proximal balloon module 630 may include a fluid source 630a to which a fluid pump 630b is attached. For example, the proximal balloon activation source 620 may activate the proximal balloon module 640, such that the fluid source 630a is engaged and fluid passes from the fluid source 630a to the proximal balloon 120 via the fluid pump 630b to inflate the proximal balloon 120.

[0052] As further depicted in FIG. 6, the distal balloon activation source 622 may include, for example, a distal balloon module 632 configured to control inflation of the distal balloon 140. In these embodiments, the distal balloon module 632 may include a fluid source 632a to which a fluid pump 632b is attached. For example, the distal balloon activation source 622 may activate the distal balloon module 632, such that the fluid source 632a is engaged and fluid passes from the fluid source 632a to the distal balloon 140 via the fluid pump 632b to inflate the proximal balloon 120.

[0053] Referring still to FIG. 6, in the embodiments described herein, the controller 600 may be electrically and operably connected to the embolization device 10 via the activation sources, or any other component of the embolization device 10 described herein. For example, once the embolization device 10 is positioned at a target site within a vessel, the proximal balloon module 630 may be activated to inflate the proximal balloon 120 to a desired volume. With the proximal balloon 120 inflated, the distal balloon module 632 may be activated to inflate the distal balloon 140 to a desired volume. Once the proximal balloon 120 and the distal balloon 140 are inflated to their respective desired volume, embolization may occur at the target site.

[0054] Turning now to FIG. 7, and with reference to the embolization device of FIGS. 4 A and 4B, an illustrative method of embolizing a target area is disclosed. In these embodiments, the method may initially involve inserting a distal end 104 of a catheter 100 of an embolization device 10 into the target area, as is depicted at block 710. The catheter 100 may further include a guidewire lumen 106 configured to advance the catheter 100 into the target area via a guidewire, a proximal balloon inflation lumen 108, and a distal balloon inflation lumen 109 spaced from one another. The catheter 100 may further include a proximal balloon 120 disposed on the catheter 100 and in fluid communication with the proximal balloon inflation lumen 108, a distal balloon 140 disposed on the catheter 100 and in fluid communication with the distal balloon inflation lumen 109, and a stent 160 having a proximal stent portion 162, a distal stent portion 164, and a stent neck 166 disposed therebetween, such that the proximal stent portion 162 is disposed over the proximal balloon 120 and the distal stent portion 164 is disposed over the distal balloon 140.

[0055] With the catheter 100 positioned within the target area, the method may advance to block 720, which may involve inflating the proximal balloon 120 positioned on the catheter 100. In these embodiments, the method step of inflating the proximal balloon 120 may further involve inflating the proximal balloon 120 via the proximal balloon inflation lumen 108, such that the proximal balloon 120 expands to a first diameter within the target area. Furthermore, it should be appreciated that the inflation of the proximal balloon 120 may similarly result in expansion of the proximal stent portion 162 to the first diameter, as the proximal stent portion 162 is disposed about the proximal balloon 160.

[0056] Referring still to FIG. 7, the method may further involve independently inflating the distal balloon 140 via the distal balloon inflation lumen 109, as is shown at block 730. In these embodiments, the distal balloon 140 may be inflated to a second diameter, such that the distal stent portion 164 disposed about the distal balloon 140 also expands to the second diameter. In the embodiments, described herein the first diameter of the proximal balloon 120 may be the same or different that the second diameter of the distal balloon 140.

[0057] Embodiments may be further described with references to the following numbered clauses:

[0058] Clause 1. An embolization device comprising: a catheter comprising: a guidewire lumen; a proximal balloon inflation lumen; and a distal balloon inflation lumen, wherein the guidewire lumen, the proximal balloon inflation lumen, and the distal balloon inflation lumen are spaced from one another; a proximal balloon disposed on the catheter, the proximal balloon in fluid communication with the proximal balloon inflation lumen; a distal balloon distally spaced apart from the proximal balloon and disposed on the catheter, the distal balloon in fluid communication with the distal balloon inflation lumen; and a stent having a proximal stent portion, a distal stent portion, and a stent neck disposed therebetween, the proximal stent portion disposed over the proximal balloon and the distal stent portion disposed over the distal balloon; wherein the proximal balloon and the distal balloon are configured to be inflated independently via, respectively, the proximal balloon inflation lumen and the distal balloon inflation lumen such that, when inflated, the proximal balloon is inflated via the proximal balloon inflation lumen to a first diameter such that the proximal stent portion expands to the first diameter and the distal balloon is inflated via the distal balloon inflation lumen to a second diameter such that the distal stent portion expands to the second diameter.

[0059] Clause 2. The embolization device of clause 1, wherein the proximal balloon, the distal balloon and the stent each include a radiopaque band.

[0060] Clause 3. The embolization device of clause 1 or 2, wherein a length of the stent is equal to a combined length between outer ends of the proximal balloon and the distal balloon.

[0061] Clause 4. The embolization device of any of clauses 1-3, wherein a proximal balloon length of the proximal balloon is one of equal to or different from a distal balloon length of the distal balloon.

[0062] Clause 5. The embolization device of any of clauses 1-4, wherein the stent neck includes a proximal neck end and a distal neck end, the proximal neck end being positioned towards a proximal end of the catheter and the distal neck end being positioned towards a distal end of the catheter.

[0063] Clause 6. The embolization device of any of clauses 1-5, wherein the proximal balloon is proximally positioned past the proximal neck end of the stent neck and the distal balloon is distally positioned past the distal neck end of the stent neck.

[0064] Clause 7. The embolization device of any of clauses 1-6, wherein the first diameter is different from the second diameter.

[0065] Clause 8. The embolization device of any of clauses 1-7, wherein the first diameter is equal to the second diameter.

[0066] Clause 9. The embolization device of any of clauses 1-8, wherein the stent comprises coils.

[0067] Clause 10. An embolization device comprising: a catheter comprising: a proximal end and a distal end; a guidewire lumen extending from the proximal end to the distal end of the catheter; a proximal balloon inflation lumen extending at least a portion from the proximal end to the distal end of the catheter; and a distal balloon inflation lumen extending at least a portion from the proximal end to the distal end of the catheter, wherein the guidewire lumen, the proximal balloon inflation lumen, and the distal balloon inflation lumen are spaced from one another; a proximal balloon disposed on the catheter, the proximal balloon in fluid communication with the proximal balloon inflation lumen; a distal balloon disposed on the catheter, the distal balloon in fluid communication with the distal balloon inflation lumen; and a stent having a proximal stent portion disposed over the proximal balloon and a distal stent portion disposed over the distal balloon; wherein the proximal balloon and the distal balloon are configured to be inflated independently via, respectively, the proximal balloon inflation lumen and the distal balloon inflation lumen such that, when inflated, the proximal balloon is inflated via the proximal balloon inflation lumen to a first diameter such that the proximal stent portion expands to the first diameter and the distal balloon is inflated via the distal balloon inflation lumen to a second diameter such that the distal stent portion expands to the second diameter.

[0068] Clause 11. The embolization device of clause 10, wherein the proximal stent portion completely surrounds the proximal balloon in a circumferential direction and the distal stent portion completely surrounds the distal balloon in the circumferential direction.

[0069] Clause 12. The embolization device of clauses 10 or 11, wherein a proximal balloon length of the proximal balloon is equal to a distal balloon length of the distal balloon.

[0070] Clause 13. The embolization device of any of clauses 10-12, wherein a proximal balloon length of the proximal balloon is different from a distal balloon length of the distal balloon.

[0071] Clause 14. The embolization device of any of clauses 10-13, wherein a length of the proximal stent portion is equal to a proximal balloon length of the proximal balloon, and a length of the distal stent portion is equal to a distal balloon length of the distal balloon.

[0072] Clause 15. The embolization device of any of clauses 10-14, wherein the proximal balloon and the distal balloon each include a radiopaque band.

[0073] Clause 16. A method of embolizing a target area comprising: inserting a distal end of a catheter of an embolization device into the target area, the catheter having a guidewire lumen, a proximal balloon inflation lumen, and a distal balloon inflation lumen spaced from one another, the embolization device further including a proximal balloon disposed on the catheter and in fluid communication with the proximal balloon inflation lumen, a distal balloon disposed on the catheter and in fluid communication with the distal balloon inflation lumen, and a stent having a proximal stent portion, a distal stent portion, and a stent neck disposed therebetween, the proximal stent portion disposed over the proximal balloon and the distal stent portion disposed over the distal balloon; inflating the proximal balloon via the proximal balloon inflation lumen of the catheter to a first diameter in the target area to expand the proximal stent portion to the first diameter; and independently inflating the distal balloon via the distal balloon inflation lumen of the catheter to a second diameter in the target area to expand the distal stent portion to the second diameter.

[0074] Clause 17. The method of clause 16, wherein the first diameter of the proximal balloon is different from the second diameter of the distal balloon.

[0075] Clause 18. The method of clauses 16 or 17, wherein the catheter comprises a proximal end, the guidewire lumen extending from the proximal end to the distal end, the proximal balloon inflation lumen extending at least a portion from the proximal end to the distal end, and the distal balloon inflation lumen extending at least a portion from the proximal end to the distal end.

[0076] Clause 19. The method of any of clauses 16-18, wherein a length of the stent is equal to a combined length between outer ends of the proximal balloon and the distal balloon.

[0077] Clause 20. The method of any of clauses 16-19, wherein the proximal balloon and the distal balloon each include a radiopaque band used for positioning the proximal balloon at a proximal position in the target area and positioning the distal balloon at a distal position in the target area.

[0078] As should be appreciated in view of the foregoing, an embolization device is described herein. The embolization device may include a catheter that defines a proximal balloon inflation lumen and a distal balloon inflation lumen, with the proximal balloon inflation lumen being fluidly coupled to a proximal balloon disposed on the catheter and the distal balloon inflation lumen being fluidly coupled to a distal balloon positioned on the catheter. The embolization device may further include a stent that includes a proximal stent portion disposed about the proximal balloon, a distal stent portion disposed about the distal balloon, and a stent neck disposed between the proximal balloon and the distal balloon. The embolization device may also include plurality of fluid sources, such as a first fluid source and a second fluid source, for independently inflating the proximal balloon and the distal balloon, respectively. As has been described herein, the proximal balloon may be inflated to a first diameter by transferring fluid from the first fluid source to the proximal balloon via the proximal balloon inflation lumen, while the distal balloon may be inflated to a second diameter by transferring fluid from the second fluid source to the distal balloon via the distal balloon inflation lumen. Furthermore, the inflation of the proximal balloon and the distal balloon, respectively, may further result in the expansion of the proximal stent portion and the distal stent portion to the first and second diameters, respectively. The first diameter of the proximal balloon may be different from the second diameter of the distal balloon, which may aid in embolizing asymmetrical occlusions positioned within a target area.

[0079] The terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. As used herein, the singular forms “a,” “an,” and “the” are intended to include the plural forms, including “at least one,” unless the content clearly indicates otherwise. “Or” means “and/or.” As used herein, the term “and/or” includes any and all combinations of one or more of the associated listed items. It will be further understood that the terms “comprises” and/or “comprising,” or “includes” and/or “including” when used in this specification, specify the presence of stated features, regions, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, regions, integers, steps, operations, elements, components, and/or groups thereof. The term “or a combination thereof’ means a combination including at least one of the foregoing elements.

[0080] It is noted that the terms "substantially" and "about" may be utilized herein to represent the inherent degree of uncertainty that may be attributed to any quantitative comparison, value, measurement, or other representation. These terms are also utilized herein to represent the degree by which a quantitative representation may vary from a stated reference without resulting in a change in the basic function of the subject matter at issue.

[0081] While particular embodiments have been illustrated and described herein, it should be understood that various other changes and modifications may be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects need not be utilized in combination. It is therefore intended that the appended claims cover all such changes and modifications that are within the scope of the claimed subject matter.

Claims

1. An embolization device comprising: a catheter comprising: a guidewire lumen; a proximal balloon inflation lumen; and a distal balloon inflation lumen, wherein the guidewire lumen, the proximal balloon inflation lumen, and the distal balloon inflation lumen are spaced from one another; a proximal balloon disposed on the catheter, the proximal balloon in fluid communication with the proximal balloon inflation lumen; a distal balloon distally spaced apart from the proximal balloon and disposed on the catheter, the distal balloon in fluid communication with the distal balloon inflation lumen; and a stent having a proximal stent portion, a distal stent portion, and a stent neck disposed therebetween, the proximal stent portion disposed over the proximal balloon and the distal stent portion disposed over the distal balloon; wherein the proximal balloon and the distal balloon are configured to be inflated independently via, respectively, the proximal balloon inflation lumen and the distal balloon inflation lumen such that, when inflated, the proximal balloon is inflated via the proximal balloon inflation lumen to a first diameter such that the proximal stent portion expands to the first diameter and the distal balloon is inflated via the distal balloon inflation lumen to a second diameter such that the distal stent portion expands to the second diameter.

2. The embolization device of claim 1, wherein the proximal balloon, the distal balloon and the stent each include a radiopaque band.

3. The embolization device of claim 1, wherein a length of the stent is equal to a combined length between outer ends of the proximal balloon and the distal balloon.

4. The embolization device of claim 1, wherein a proximal balloon length of the proximal balloon is one of equal to or different from a distal balloon length of the distal balloon.

5. The embolization device of claim 1, wherein the stent neck includes a proximal neck end and a distal neck end, the proximal neck end being positioned towards a proximal end of the catheter and the distal neck end being positioned towards a distal end of the catheter.

6. The embolization device of claim 5, wherein the proximal balloon is proximally positioned past the proximal neck end of the stent neck and the distal balloon is distally positioned past the distal neck end of the stent neck.

7. The embolization device of claim 1, wherein the first diameter is different from the second diameter.

8. The embolization device of claim 1, wherein the first diameter is equal to the second diameter.

9. The embolization device of claim 1, wherein the stent comprises coils.

10. An embolization device comprising: a catheter comprising: a proximal end and a distal end; a guidewire lumen extending from the proximal end to the distal end of the catheter; a proximal balloon inflation lumen extending at least a portion from the proximal end to the distal end of the catheter; and a distal balloon inflation lumen extending at least a portion from the proximal end to the distal end of the catheter, wherein the guidewire lumen, the proximal balloon inflation lumen, and the distal balloon inflation lumen are spaced from one another; a proximal balloon disposed on the catheter, the proximal balloon in fluid communication with the proximal balloon inflation lumen; a distal balloon disposed on the catheter, the distal balloon in fluid communication with the distal balloon inflation lumen; and a stent having a proximal stent portion disposed over the proximal balloon and a distal stent portion disposed over the distal balloon; wherein the proximal balloon and the distal balloon are configured to be inflated independently via, respectively, the proximal balloon inflation lumen and the distal balloon inflation lumen such that, when inflated, the proximal balloon is inflated via the proximal balloon inflation lumen to a first diameter such that the proximal stent portion expands to the first diameter and the distal balloon is inflated via the distal balloon inflation lumen to a second diameter such that the distal stent portion expands to the second diameter.

11. The embolization device of claim 10, wherein the proximal stent portion completely surrounds the proximal balloon in a circumferential direction and the distal stent portion completely surrounds the distal balloon in the circumferential direction.

12. The embolization device of claim 10, wherein a proximal balloon length of the proximal balloon is equal to a distal balloon length of the distal balloon.

13. The embolization device of claim 10, wherein a proximal balloon length of the proximal balloon is different from a distal balloon length of the distal balloon.

14. The embolization device of claim 10, wherein a length of the proximal stent portion is equal to a proximal balloon length of the proximal balloon, and a length of the distal stent portion is equal to a distal balloon length of the distal balloon.

15. The embolization device of claim 10, wherein the proximal balloon and the distal balloon each include a radiopaque band.

16. A method of embolizing a target area comprising: inserting a distal end of a catheter of an embolization device into the target area, the catheter having a guidewire lumen, a proximal balloon inflation lumen, and a distal balloon inflation lumen spaced from one another, the embolization device further including a proximal balloon disposed on the catheter and in fluid communication with the proximal balloon inflation lumen, a distal balloon disposed on the catheter and in fluid communication with the distal balloon inflation lumen, and a stent having a proximal stent portion, a distal stent portion, and a stent neck disposed therebetween, the proximal stent portion disposed over the proximal balloon and the distal stent portion disposed over the distal balloon; inflating the proximal balloon via the proximal balloon inflation lumen of the catheter to a first diameter in the target area to expand the proximal stent portion to the first diameter; and independently inflating the distal balloon via the distal balloon inflation lumen of the catheter to a second diameter in the target area to expand the distal stent portion to the second diameter.

17. The method of claim 16, wherein the first diameter of the proximal balloon is different from the second diameter of the distal balloon.

18. The method of claim 16, wherein the catheter comprises a proximal end, the guidewire lumen extending from the proximal end to the distal end, the proximal balloon inflation lumen extending at least a portion from the proximal end to the distal end, and the distal balloon inflation lumen extending at least a portion from the proximal end to the distal end.

19. The method of claim 18, wherein a length of the stent is equal to a combined length between outer ends of the proximal balloon and the distal balloon.

20. The method of claim 16, wherein the proximal balloon and the distal balloon each include a radiopaque band used for positioning the proximal balloon at a proximal position in the target area and positioning the distal balloon at a distal position in the target area.