Balloon anchoring guide catheter extension

A guide catheter extension, having a push member having a proximal end and a distal end; a tube frame coupled to the distal end of the push member, the tube frame defining a lumen having a diameter sufficient to receive an interventional vascular device therethrough; and an inflatable element coupled to the tube frame, wherein the inflatable element is expandable into the lumen.

FIELD OF THE INVENTION

The present disclosure relates to systems and methods of use thereof for capturing or securing intravascular devices.

BACKGROUND OF THE INVENTION

In coronary artery disease, the coronary arteries may be narrowed or occluded by atherosclerotic plaques or other lesions. These lesions may totally obstruct the lumen of the artery or may dramatically narrow the lumen of the artery. In order to diagnose and treat obstructive coronary artery disease, it is commonly necessary to pass a guidewire or other interventional instruments through and beyond the occlusion or stenosis of the coronary artery.

Percutaneous coronary intervention (PCI), also known as coronary angioplasty, is a therapeutic procedure used to treat the narrowed or stenotic section of the coronary artery of the heart due to coronary lesions or obstructions. A guide catheter may be used in PCI to support easier passage for another catheter or interventional device, such as, a microcatheter, stents or balloons, to access the target site. For example, the guide catheter can be inserted through the aorta and into the ostium of the coronary artery. Once seated in the opening or ostium of the coronary artery a guidewire or other instrument can be passed through the lumen of the guide catheter and then inserted into the artery distal to the occlusion or stenosis.

However, guide catheters may encounter certain difficulties. The anatomy in the area for placement, e.g., the coronary vasculature, may be tortuous and the lesions themselves may be comparatively non-compliant. Moreover, when crossing comparatively non-compliant lesions, a backward force sufficient to dislodge the guide catheter from the ostium of the artery being treated can be generated. In order to improve backup support, guide catheter extension devices may be employed to facilitate placement and approach of one or more treatment devices in and around a stenotic region.

For example, when treating a chronic total occlusion (“CTO”), certain techniques employ multiple devices to approach the CTO both from antegrade and retrograde directions. Either of these techniques, or other similar procedures, involve routing and controlling multiple devices in and around a guide catheter and guide catheter extension device in prolixity to a CTO or other physiological condition/region. The present disclosure provides devices and methods of use thereof for selectively securing one or more medical devices in and around a guide catheter extension for such procedures.

SUMMARY OF THE INVENTION

The present invention advantageously provides a guide catheter extension, comprising: a push member having a proximal end and a distal end; a tube frame coupled to the distal end of the push member, the tube frame defining a lumen having a diameter sufficient to receive an interventional vascular device therethrough; and an inflatable element coupled to the tube frame, wherein the inflatable element is expandable into the lumen. The inflatable element may be expandable to occupy between 10% and 90% of a cross-sectional area of the lumen. The inflatable element may be expandable outward beyond an exterior surface of the tube frame. The tube frame may define a window therein through which the inflatable element is expandable outward beyond an exterior surface of the tube frame. The push member may include an inflation lumen in fluid communication with an interior of the inflatable element. At least a portion of the inflation lumen may define an arcuate cross-section having a radius of curvature equal to a radius of the lumen of the tube frame. The guide catheter extension may include a tongue element extending from a proximal segment of the tube frame, wherein the tongue element is directly coupled to the distal region of the push member.

A guide catheter extension is disclosed, including a push member having a proximal end and a distal end; a tube frame coupled to the distal end of the push member, the tube frame defining a lumen having a diameter sufficient to receive an interventional vascular device therethrough; a first inflatable element coupled to the tube frame, wherein the first inflatable element is expandable into the lumen; and a second inflatable element coupled to the tube frame, wherein the second inflatable element is expandable outward beyond an exterior surface of the tube frame. The first inflatable element may be expandable to occupy between 10% and 90% of a cross-sectional area of the lumen. The first and second inflatable elements may be independently expandable. The push member may include a first inflation lumen in fluid communication with an interior of the first inflatable element. At least a portion of the first inflation lumen may define an arcuate cross-section having a radius of curvature equal to a radius of the lumen of the tube frame. The push member may include a second inflation lumen in fluid communication with an interior of the second inflatable element.

A guide catheter extension is provided, having a push member having a proximal end and a distal end; a tube frame coupled to the distal end of the push member, the tube frame defining a lumen having a diameter sufficient to receive an interventional vascular device therethrough; and an inflatable element movably coupled to the push member. The inflatable element may be movable along a longitudinal axis of the push member. The inflatable element may be coaxially mounted on the push member. The guide catheter extension may include an inflation lumen in fluid communication with an interior of the inflatable element, wherein the inflation lumen is coaxial with the push member. The inflatable element may be expandable to a size between 10% and 90% of a cross-sectional area of the lumen of the tube frame.

DETAILED DESCRIPTION OF THE INVENTION

The present disclosure provides systems, devices, and methods of use thereof for capturing and/or securing intravascular devices within the anatomy which may include, for example, securing or capturing a guidewire or other minimally-invasive intravascular devices during the assessment and/or treatment of chronic total occlusions (“CTO”). Such assessment and/or treatment of chronic total occlusions may include, for example, CART, reverse CART, and other techniques that employ multiple devices to approach a CTO both from antegrade and retrograde directions and include the desire to capture or secure the devices in place during use.

Now referring to the figures, an example of an intravascular device in the form of a guide catheter extension1000is shown that can be used to secure or capture one or more guidewires and/or other minimally-invasive intravascular devices during a medical procedure to assess and/or treat occlusions or other vascular defects or conditions. The guide catheter extension1000is sized and configured to pass through and extend distally from a guide catheter ‘GC’ as described herein. The guide catheter extension1000generally includes a push member1001coupled to a distal tube frame1005, and may have sufficient length such that, in use, a proximal region of the guide catheter extension1000is accessible or positioned exterior to a patient (such as at a proximal end or hub of a separate guide catheter), while a distal region of the guide catheter extension1000extends distally outward from an end of the guide catheter positioned within the anatomy of the patient.

The push member1001may include, for example, one or more segments of hypotube, spiral-cut hypotube, multi-thread cable, interrupted-spiral cut tube, other cut geometries/configurations, or other elongated member(s), and may include one or more lumens1002therein and/or therethrough for the passage of one or more wires, devices, fluid delivery and/or aspiration features, or the like.

The push member1001may include a small diameter or cross-sectional profile relative to an inner diameter or clearance of the guide catheter to reduce the amount of space within the guide catheter that the push member1001occupies, thereby allowing one or more other devices, instruments, or otherwise to pass through the guide catheter with minimal interference or obstruction. For example, the push member1001may have a diameter or cross-sectional width between approximately 0.254 mm (0.010 inches) and approximately 2.54 mm (0.100 inches) for use in a guide catheter having an inner diameter of 1.1016-30.48 mm (0.04-1.20 inches). In a preferred example, the push member1001may have a diameter or cross-sectional width between approximately 0.254 mm (0.010 inches) and approximately 0.762 mm (0.030 inches). The push member1001may have one or more cross-sectional shapes or profiles along its length, including but not limited to circular, hemi- or semi-circular, square, rectangular, triangular, and/or oval shapes or profiles. In addition and/or alternatively, the push member1001can comprise a plurality of cut patterns in one or more sections thereof.

The push member1001may define an overall length constituting the majority of the length of the guide catheter extension1000. The length of the push member1001may be sufficient to enter an incision or patient access point (which may include, for example, a hub, hemostatic valve, and the like), traverse the vasculature of the patient, and position the tube frame1005in proximity to a desired treatment site while a portion of the push member1001remains outside the patient and accessible/operable by a physician. The length may vary depending upon the particular procedure or application being performed and/or a vasculature access point being utilized (e.g., whether introduced via a radial artery, femoral artery, contralateral access, or the like). The push member and/or other proximal portion of the guide catheter extension1000may include a stop feature that prevents a physician from inserting the extension1000too far into the guide catheter. For example, the guide catheter extension1000may include a raised protrusion, weld, or other mass that exceeds a diameter or size of a guide catheter, hemostatic valve, and/or proximal device hub to mechanically prevent the over-insertion of the guide catheter extension1000.

The tube frame1005includes or otherwise defines an outer wall1007and an inner wall1006enclosing a lumen1008having a diameter sufficient to receive an interventional vascular device therethrough, a proximal end1012, and a distal end1013. The tube frame1005has a plurality of cut patterns1015,1016therein (of note,1015and1016represent only two possible embodiments of the various cut patterns that can be present in the tube frame).

The tube frame1005may be constructed from nitinol or stainless steel. For example, the tube frame can be made from metals, polymers, or a combination of polymers and metals. Examples of materials that may be used include stainless steel (SST), nickel titanium (Nitinol), or polymers. Preferred examples of other metals which may be used include, super elastic nickel titanium, shape memory nickel titanium, Ti—Ni, nickel titanium, approximately, 55-60 wt. % Ni, Ni—Ti—Hf, Ni—Ti—Pd, Ni—Mn—Ga, Stainless Steel (SST) of SAE grade in the 300 to 400 series e.g., 304, 316, 402, 440, MP35N, and 17-7 precipitation hardened (PH) stainless steel, other spring steel or other high tensile strength material or other biocompatible metal material. In one preferred embodiment, the material is superelastic or shape memory (e.g., nickel titanium), while in another preferred embodiment, the material is stainless steel.

The tube frame1005can include a superelastic alloy (generally referred to as “a shape-memory alloy”) in its entirety, or in only in selected sections thereof. Examples of such superelastic alloys include: Elgiloy® and Phynox®, spring alloys, SAE grade 316 stainless steel and MP35N (Nickel Cobalt), and superelastic Nitinol.

Alternatively, the tube frame may be formed from polymers, e.g., include polyimide, PEEK, nylon, polyurethane, polyethylene terephthalate (PET), latex, HDHMWPE (high density, high molecular weight polyethylene) and thermoplastic elastomers or other polymers with similar mechanical properties.

The tube frame1005may be made by forming a pipe of a super elastic metal and then removing the parts of the pipe where the notches or holes are to be formed. The notches, holes or cuts can be formed in the pipe by laser (solid-state, femtosecond laser, or YAG laser, for example), electrical discharge (electrical discharge machining (EDM)), chemical etching, photo-etching mechanical cutting, or a combined use of any of these techniques.

A portion of the tube frame1005can have a polymer liner and/or the outer wall of the tube frame1005can be covered (completely, partially, and/or intermittently) with an outer jacket.

The tube frame1005has a tongue element1017extending from the proximal end1012of the tube frame1005, and the tongue element1017is coupled to the push member1001. The tongue element1017may be unitary with and be formed from the same material composition as the tube frame1005. A distal end or region of the tongue element1017may be positioned distally to the proximal opening of the tube frame1005, while a proximal end or region of the tongue element1017extends proximally past the proximal opening of the tube frame1005.

The proximal end1012of the tube frame1005may include a flare or flange1019that can be used to close or reduce the gap between the tube frame1005and the guide catheter GC.

Additional features and characteristics of the guide catheter extension1000, including the push member1001, the distal tube frame1005, and other components, are set forth in U.S. Patent Application Ser. No. 62/729,282, entitled ‘GUIDE CATHETER EXTENSION PLATFORM,’ the entirety of which is incorporated herein by reference.

The guide catheter extension1000may include one or more inflatable elements1020positioned within the lumen1008of the distal tube frame. The inflatable element(s)1020may include one or more balloons, bladders, or other component that is expandable upon the introduction of a fluid therein. The inflatable element may be formed in a variety of shapes, and may include symmetrical, asymmetrical, or other contoured or geometrical configurations. The inflatable element(s)1020may include compliant and/or non-compliant surfaces and/or components, which may for example, be constructed from silicone, nylon, pebax, and/or other polymers.

In the example illustrated inFIGS.1-6, the inflatable element1020is disposed on or about the inner wall1006towards the distal end1013of the tube frame1005. The inflatable element1020is situated and operable to expand within the lumen1008of the distal tube frame1005. Accordingly, the inflatable element1020may be adhered or otherwise positioned directly onto an inner wall1006of the distal tube frame.

In the example illustrated inFIGS.7-12, the inflatable element1020is disposed on or about the inner wall1006towards the distal end1013of the tube frame1005, and the inflatable element1020is situated and operable to expand both within the lumen1008of the distal tube frame1005, and into the space between the guide catheter extension1000and the surrounding, external guide catheter GC. To accommodate such expansion characteristics, a portion of the wall of the distal tube frame1005may be cut to form a window or space allowing the inflatable element1020to expand both inwards within the lumen1008and outwards towards the guide catheter GC.

The inflatable element1020may include a single internal cavity to expand both into the lumen1008and outside of the diameter or outer wall of the tube frame1005and into the space between the guide catheter extension1000and the guide catheter GC. In an alternative example, the inflatable element1020may include multiple inner cavities and/or reservoirs that are independently inflatable such that the portion of the inflatable element1020that expands into the lumen1008is controllable inflatable independently and separately from the portion of the inflatable element1020that expands outside of the diameter or outer wall of the tube frame1005. The separate portions of the inflatable element1020may have independent inflation lumens to provide independent operation. In another example, multiple separate inflatable elements may be employed to provide the independent inflation within the lumen1008and outside of the tube frame1005.

In use, the inflatable element1020may be transitionable from a first state in which the inflatable element is substantially planar, flat, and/or otherwise uninflated to a second state where the inflatable element1020is inflated, and expands to occupy a substantial portion of the diameter of the lumen1008of the distal tube frame, less the cross-sectional area of any devices running therethrough. For example, the inflated inflatable element may provide the expansion capacity to occupy between approximately 10% and approximately 90% of the cross-sectional area of the lumen1008. The particular expansion needed for a particular procedure may vary depending on the number and dimensions of the auxiliary devices that a physician is entrapping or securing within the lumen1008. If a single device with a relatively small diameter is being secured, then a larger expansion of the inflatable element1020may be employed. In contrast, a lesser degree of expansion of the inflatable element1020will be required to secure multiple devices having large cross-sectional areas within the lumen1008. The expansion and/or conformance of the inflatable element1020may vary along the longitudinal length of the of the inflatable element1020to accommodate varying dimensions of the devices being secured in the lumen1008(e.g., for example, should one or more of the captured devices have a varying cross-section or external dimensions along a length thereof).

In an example where a portion of the inflatable element1020expands outwards into the space between the guide catheter GC and the guide catheter extension1000, the inflatable element1020may be expanded to substantially fill the cross-sectional space between the guide catheter GC and the guide catheter extension1000, as described further herein.

The inflatable element1020is in fluid communication with the lumen1002of the push member1001, which may be used as a channel to introduce an inflation medium (such as air, saline, distilled water, or otherwise) into the inflatable element1020. The inflatable element1020may be directly coupled to the push member1001, or may alternatively couple to the push member1001through an intermediary inflation spout or channel1021that extends through a portion of the distal tube frame1005and extends outwards to connect to the push member1001in a proximal direction, while also coupling the inflatable element1020in a distal direction. In the illustrated example, the intermediary inflation channel1021has a low cross-sectional profile, and a curvature complementary to that of the lumen1008, to avoid substantially obstructing or reducing the operating diameter of the lumen1008and the resultant ability to pass other devices or instruments therethrough. A portion of the wall thickness of the tube frame1005may be reduced to create a groove to further accommodate the intermediary inflation spout or channel1021and to further avoid substantially obstructing or reducing the operating diameter of the lumen1008.

The inflatable element(s)1020may be expanded by the introduction of a fluid therein, which may be provided at a proximal hub or injection port (not shown) on the guide catheter extension1000. Controllable expansion of the inflatable element1020may be facilitated by a pump, syringe, media cartridge, or other fluid introduction mechanisms employed in vascular procedures, and may be monitored through one or more sensors, medical imaging modalities, or the like.

In one example of use, the guide catheter extension1000may be used to capture and secure one or more auxiliary devices within the vasculature of a patient. For example, when treating a CTO, certain techniques employ multiple devices to approach the CTO both from antegrade and retrograde directions. In the CART technique, a guidewire is directed antegrade towards the CTO lesion, while a retrograde balloon device is advanced into the CTO lesion to make a crack or opening. In the reverse-CART technique, the creation of a subintimal crack is conducted by an antegrade balloon at the proximal part of the CTO lesion, while a guidewire approaches distally and retrograde of the lesion. In either of these techniques, or other procedures involving multiple devices in and around a CTO or other physiological condition/region, the guide catheter extension1000may be used to secure the distal end of the targeted auxiliary device(s), which may include a retrograde balloon device in the CART technique and/or a retrograde guidewire in the reverse CART technique. In other situations, it may be desired to capture one or more device portions in antegrade and/or retrograde regions of a CTO.

FIGS.13-18illustrate such an example of use, where a plurality of auxiliary devices1022a,1022b,1022c(collectively, ‘auxiliary devices1022’) are at least partially positioned within the inner lumen1008of the distal tube frame1005, and secured in place by the expanded inflatable element1020. The illustrated example shows the auxiliary devices1022extending completely through the distal tube frame1005, however, it is contemplated that the length and position of antegrade and/or retrograde auxiliary devices1022relative to the distal tube frame may vary so long as there is sufficient overlap between the auxiliary devices1022and the inflatable element1020to secure the devices within the lumen1008. In the embodiment where the inflatable element1020expands exterior to the distal tube frame1005and into the space between the external guide catheter GC and the guide catheter extension1000, the expansion of the inflatable element1020will secure both the relative position of the auxiliary devices1022within the lumen1008as well as securing the relative position of the guide catheter extension1000within the guide catheter GC. The relatively distal location of the inflatable element1020allows a physician to capture devices within the lumen1008with minimal and/or reduced length of the auxiliary devices1022required to enter the guide catheter extension1000, and eliminates the need to entrain the auxiliary devices1022further proximal into the external guide catheter GC itself. This reduces the maneuvering and navigation required by a physician to secure the auxiliary devices1022compared to other devices which may entrain and trap auxiliary devices within the GC.

In another example, the device1000may include an inflatable element1020positioned on the push member1001, as shown inFIGS.19-20. This example of the device1000may be used to secure one or more auxiliary devices1022similarly as described above, with the securing location being proximal of the tube frame1005rather than inside the tube frame1005. In the illustrated example, the inflatable element1020may be slidably mounted or coupled to the push member1001such that it can be moved along the length of a longitudinal axis of the push member1001in proximal and distal directions. For example, the inflatable element1020may be attached to a shaft1030that is coaxially and/or concentrically mounted on the push member1001to provide the slidable movement. The shaft1030may include one or more lengths of varying tube along a length thereof, and one or more portions of the inflatable element1020may be attached to the shaft1030at one or more joints. The shaft may include or define one or more inflation lumens1032therein. The lumen(s)1032may include one or more segments of an inner diameter of the shaft1030, one or more tubes positioned within the shaft1030, and/or one or more spaces between the shaft1030and the push member1001that provide a fluid path into an interior of the inflatable element1020. The inflation lumen(s)1032may be attached to an inflation source at a proximal end or hub of the device1000as described herein.

It will be appreciated by persons skilled in the art that the present disclosure is not limited to what has been particularly shown and described herein above. In addition, unless mention was made above to the contrary, it should be noted that all of the accompanying drawings are not to scale. Of note, the system components have been represented where appropriate by conventional symbols in the drawings, showing only those specific details that are pertinent to understanding the embodiments of the present disclosure so as not to obscure the disclosure with details that will be readily apparent to those of ordinary skill in the art having the benefit of the description herein. Moreover, while certain embodiments or figures described herein may illustrate features not expressly indicated on other figures or embodiments, it is understood that the features and components of the examples disclosed herein are not necessarily exclusive of each other and may be included in a variety of different combinations or configurations without departing from the scope and spirit of the disclosure. A variety of modifications and variations are possible in light of the above teachings without departing from the scope and spirit of the disclosure, which is limited only by the following claims.