Patent ID: 12201541

The present disclosure is susceptible to various modifications and alternative forms. Some representative embodiments have been shown by way of example in the drawings and will be described in detail herein. It should be understood, however, that the invention is not intended to be limited to the particular forms disclosed. Rather, the disclosure is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the appended claims.

DETAILED DESCRIPTION OF ILLUSTRATED EMBODIMENTS

The present invention is described with reference to the attached figures, where like reference numerals are used throughout the figures to designate similar or equivalent elements. The figures are not drawn to scale, and they are provided merely to illustrate the instant invention. Several aspects of the invention are described below with reference to example applications for illustration. It should be understood that numerous specific details, relationships, and methods are set forth to provide a full understanding of the invention. One having ordinary skill in the relevant art, however, will readily recognize that the invention can be practiced without one or more of the specific details, or with other methods. In other instances, well-known structures or operations are not shown in detail to avoid obscuring the invention. The present invention is not limited by the illustrated ordering of acts or events, as some acts may occur in different orders and/or concurrently with other acts or events. Furthermore, not all illustrated acts or events are required to implement a methodology in accordance with the present disclosure.

FIG.1illustrates an aortic bifurcation and tortuous peripheral artery100, in accordance with an embodiment of this disclosure. The tortuous peripheral artery100can include an abdominal aortic bifurcation with tortuous branch arteries. The tortuous branch arteries can include a right renal artery101band a left renal artery101aextending from an abdominal aorta102. The abdominal aorta102can be parted at an aortic bifurcation115, and connected to arteries of the lower limbs. The arteries of the lower limbs can include a right common iliac103and a left common iliac104. The left common iliac104can be split into a left external iliac106and a left internal iliac112a. The left external iliac106can be connected to a left common femoral108, and further split into a left deep femoral113a, and a left superficial femoral110. The

The right common iliac103can be connected to a right external iliac105. The right external iliac105can be connected to a right common femoral107, which splits into a right deep femoral113band a right superficial femoral109.FIG.1illustrates the tortuous nature of the peripheral arteries.

When performing interventions within the tortuous peripheral artery100, it is common to encounter difficulties associated with access and pushability. For example, a highly angulated aortic bifurcation115or the extremely tortuous common iliac arteries103and104can be extremely difficult to traverse. Furthermore, these arteries can contain calcific plaques or other obstructions which can add anatomic and technical challenges when traversing the tortuous peripheral artery100.

FIG.2illustrates a tortuous anatomical pathway200from the percutaneous access within the common femoral artery on the contralateral side to a potential procedure location on the ipsilateral side, in accordance with an embodiment of the disclosure. In some embodiments, interventional devices such as wires and catheters are pushed from the contralateral access at point ‘X’ to the treatment site ‘Y’. The devices would need to travel through the general pathways1through9. Due to the multi directional twists and turns along the pathways1through9, the devices can suffer from a significant loss of performance such as torque and pushability. WhileFIG.2illustrates the tortuous anatomical pathway200in a two-dimensional format, the tortuousity of the anatomical pathway200is often significantly more severe, as illustrated inFIG.1.

FIG.3Aillustrates a guide sheath300with an integrated stabilization wire302in accordance with an embodiment of the disclosure. The guide sheath300can include an elongate member301with a proximal end305and a distal end304located opposite of the proximal end305. The elongate member301can be made up of materials commonly known in the art including, for example, metal tubing, reinforced or unreinforced polymeric tubing with or without radiopaque fillers, or combinations thereof. The metal tubing can include stainless steel, nickel titanium, cobalt chromium, copper, aluminum, or the like. The reinforced polymeric tubing can include braid or coil structures or combinations thereof. The reinforced polymeric tubing can be made up of stainless steel, nickel titanium, composites, metal reinforced polymer, polymer, or a combination thereof. The elongate member301can further include one or more radiopaque markers along its length, such as distal radiopaque marker308and proximal radiopaque marker309. The radiopaque markers308and309can be at the distal tip or at the transition point of bifurcation and located between the proximal and distal end of the elongate member301. Alternatively, the radiopaque markers308and309can be located between the midpoint and distal end of the elongate member301.

The distal radiopaque marker308can provide visualization of the distal most tip of the elongate member301under fluoroscopy. The proximal radiopaque marker309can provide the user with a visual guidance as to the exact location of the stabilization wire transition306under fluoroscopy to aid in positioning at the ipsilateral access. The radiopaque markers308and309can be a coil, a tube fabricated using gold, platinum, iridium, barium sulfate loaded polymers, or a combination thereof. The radiopaque markers308and309can be attached to the elongate member301using welding, heat fusing, adhesive bonding, mechanical locking, crimping, laminating, soldering, or the like.

The proximal end305can include a hub with hemostasis valve310and a side port311that may include a stopcock with luer connector313. The distal end304can include a stabilization wire transition306connected to the side wall of the elongate member301. The hub with hemostasis valve310can be a valve and hemostatic device such as a touhy borst valve, duck-bill valve, o-ring, or a combination thereof. The hemostasis valve310can allow passage of procedural catheters and interventional devices through the lumen312of elongate member301while maintaining hemostasis. In some embodiments, the stopcock with luer connector313facilitates communication with the lumen312of the elongate member301and facilitates an injection of fluids, such as saline, contrast, CO2gas or medicines. The stabilization wire302bifurcates alongside the elongate member301at the stabilization wire transition306and extends beyond the distal section of the guide sheath300. The stabilization wire302can include a distal segment307.

In some embodiments, the stabilization wire302can be made up of a solid or hollow member with a cross-section that is round, flat, rectangular, or a combination thereof. The stabilization wire302can be fabricated using commonly known materials in the art including, for example, stainless steel, nickel titanium, composites, metal reinforced polymer, polymer, a combination thereof, or the like. The stabilization wire302can be attached to the elongate member301by methods known in the art including, for example, welding, heat fusing, adhesive bonding, mechanical locking, crimping, laminating, soldering, or the like.

The stabilization wire302can be connected to the elongate member301by a single point at the stabilization wire transition306. In alternative embodiments, a proximal segment of the stabilization wire302can be embedded within or along at least some portion of an elongate member wall (not shown) within the elongate member301. In addition, the distal segment307of the stabilization wire302can be reduced in size to enhance flexibility using methods commonly known in the art including, for example, centerless grinding, necking, drawing, cold working, and the like.

The distal segment307of the stabilization wire302can be made up of radiopaque material to provide enhanced visualization under fluoroscopic guidance. The radiopaque material can include a coil, a tube or the like. The radiopaque material can be fabricated using materials commonly known in the art including, for example, gold, platinum, iridium, barium sulfate loaded polymers, or a combinations thereof, or the like. The radiopaque material can be attached to the distal segment307of the stabilization wire302using methods commonly known in the art including, for example, welding, heat fusing, adhesive bonding, mechanical locking, crimping, laminating, soldering, or the like.

FIG.3Billustrates the guide sheath300with dilator303coaxially assembled within the guide sheath300. The dilator303can include a distal end314. In some embodiments, the dilator303can be assembled within the lumen312of the guide sheath300. The dilator303can include a lumen (not shown) disposed along its length sized to facilitate passage of endovascular guide wires. The dilator303can be constructed using a rod or tube fabricated using methods and materials such as metallic and polymeric materials with or without radiopaque fillers (e.g. stainless steel, Nitinol, Pebax, high or low density Polyethylene, Nylon, Polypropylene, combinations thereof, or the like). The dilator303can be made using fabrication methods such as extrusion, drawing, injection molding, 3-D printing, or combinations thereof. The dilator distal end314can incorporate a tapered tip to smoothen the dimensional transition between the elongate member301to a guide wire (not shown) that may be disposed within the lumen (not shown) of the dilator303. The proximal end of the dilator303can include a hub315that can be reversibly locked to the hub with hemostasis valve310of the guide sheath300to maintain the position of the dilator303relative to the guide sheath300during delivery to the target location.

FIGS.4to8illustrate an exemplary process for endovascular treatment of tortuous aortoiliac arteries implementing the guide sheath300with integrated stabilization wire302, in accordance with an embodiment of the disclosure. Furthermore,FIGS.4to8illustrate the process of providing end-to-end stability to any procedural catheters and other interventional devices introduced through the procedural lumen312of the guide sheath300.

FIG.4illustrates a diagram400where a main access sheath401is introduced percutaneously over an access guide wire316through the contralateral femoral access site402and into the right common femoral artery107using standard technique. The main access sheath401can include a 7 French vascular introducer sheath. The access guide wire316can typically be positioned such that it can gain access to the ipsilateral common femoral artery and/or to the ipsilateral vasculature. The dilator (not shown) of the main access sheath401can be loaded and advanced over the access guide wire316towards the right external iliac artery105and right common iliac artery103until the tip of main access sheath401reaches the aortic bifurcation115.

Once the tip of main access sheath401reaches the aortic bifurcation115, the main access sheath dilator (not shown) is removed while the main access sheath401and the access guide wire316are left in place. The main access sheath401can be positioned under fluoroscopic guidance with the aid of radiopaque tip marker405.FIG.4also illustrates the percutaneous introduction of a low profile, ipsilateral femoral access sheath403through access site404to introduce a snare device (not shown) into the left common femoral artery108on the ipsilateral side. The ipsilateral femoral access sheath403can include a 4 French vascular introducer sheath.

FIG.5illustrates a process of inserting a snare device504into the ipsilateral femoral access sheath403and advancing the snare catheter504to the aortic bifurcation through the ipsilateral access. The snare catheter504can include a snare wire506introduced through the ipsilateral femoral access sheath403. The snare wire506can include a 20 to 30 mm (or smaller) snare loop505at its distal end. The snare catheter504can be advanced towards the aortic bifurcation115to position the snare loop505in the abdominal aorta to accept and capture the stabilization wire302. The dilator303of guide sheath300can be loaded over the access guide wire316and positioned close to the proximal hub402of the main access sheath401.

FIG.6illustrates a process of inserting the guide sheath300(ofFIG.3A) through the main access sheath401(ofFIG.4), in accordance with an embodiment of the disclosure. The guide sheath300can include an integrated stabilization wire302exposed at or about the distal tip of the main access sheath401. In some embodiments, the integrated stabilization wire302of guide sheath300is first introduced into main access sheath401with the aid of a guide wire introducer (not shown) and advanced alongside the pre-positioned main access guide wire316towards the aortic bifurcation115. The tip of the integrated stabilization wire302can be finally positioned inside the snare loop505. The stabilization wire302can then be captured and secured by the snare loop505by advancing the snare catheter504until the snare loop505collapses into the lumen of the snare catheter504.

FIG.7illustrates a process of applying a pull force703to the guide sheath300by retracting the snare catheter504while providing a push force701on the guide sheath300(not labeled) from the contralateral side to externalize the stabilization wire302. The pull force703can be applied to the distal end of the guide sheath300(not labeled). Of note,301which is the elongate member of the guide sheath is labeled. This pull force703is derived from the operator's retraction of the snare catheter504which has securely captured the stabilization wire302. Simultaneously, a push force701can be applied to the proximal end of the guide sheath300(not labeled). These push and pull forces enable the guidance and ease placement of sheath300(not labeled), over the aortic bifurcation115and down the ipsilateral left iliac artery104. The guide sheath300(not labeled) with the dilator303and the stabilization wire302can be guided to the left common femoral artery access site404(as shown inFIG.4). The stabilization wire302can be externalized (i.e. out of the patient's body) [not shown] by retracting it through the low profile ipsilateral access sheath403(labeled previously inFIGS.4and5). The stabilization wire302may be retracted (not shown inFIG.7, but shown inFIG.8) until the stabilization wire transition306is positioned at or about the distal tip of the low profile ipsilateral sheath403.

FIG.8illustrates a process of anchoring an externalized stabilization wire302of the guide sheath300(not labeled) to provide end-to-end stabilization for the procedural lumen. The stabilization wire302can be anchored in place by sliding a torque device801(or using any equivalent locking device) over the externalized portion of the stabilization wire302. The stabilization wire302can then be tightened or otherwise locked or anchored at or about the hub of the low profile ipsilateral access sheath403. By locking or anchoring the stabilization wire302outside the low profile ipsilateral access sheath403, the guide sheath300(not labeled) is securely stabilized and tethered. In this way, the guide sheath300(not labeled) is prevented from backing up and/or prolapsing into the abdominal aorta102when advancing procedural catheters and other interventional devices through the main lumen of guide sheath300(not labeled). Ultimately, the anchored guide sheath300(not labeled) provides superior pushability of interventional devices, thereby allowing more distal access to the ipsilateral limb vessels and enabling crossing of tight lesions or even chronic total occlusions. Furthermore, this enhanced stability enables the use of stiffer devices (e.g. atherectomy catheters), which typically may elicit prolapse of a guide sheath that is not anchored.

FIG.9provides a flow chart diagram900for accessing and stabilizing the guide sheath300with an integrated stabilization wire302in lower limb interventions, indicated by general reference character900. The process commences at step S901where the bilateral, percutaneous retrograde access is obtained for the left and right common femoral arteries.

At step S902, a guide sheath is inserted with an integrated stabilization wire through the contralateral access site and the snare device is inserted into the ipsilateral access site. At step S903, the stabilization wire is captured with the snare device and the stabilization wire at the ipsilateral access site is externalized. At step S904, the externalized stabilization wire anchored at the ipsilateral access site. Finally, the process advances to S905, where the guide sheath is used as a main pathway to deliver endovascular devices to complete the desired endovascular procedure.

While the stabilization schemes proposed above describe a guide sheath with integrated stabilization wire that can provide stability in procedures conducted in tortuous branches of major peripheral vessels of the lower extremities, it is understood that it is not meant to be exhaustive. There may be other scenarios possible for access and stabilization of procedural catheter or sheath depending on the location of the procedure and the nature of the patient such as radial or brachial access. The preferred method will vary based on the location of the procedure and the nature of the patient.