# Patent

## Title
Vascular catheter, system, and method

## Abstract

A catheter including an elongate body, a first cutting head and a second cutting head both having a blade, where the blades moves relative each other to provide a shearing action for cardiac tissue. The catheter can further include a stent positioned over an inflatable balloon, where the inflatable balloon can deploy the expandable stent over sheared cardiac tissue. The catheter can further be included in a system having a sheath, where at least a part of the catheter resides in the lumen of the sheath. The sheath further includes a cardiac valve and an expandable filter. The sheath can move relative the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent.

## Background
FIELD OF THE INVENTION
The present invention relates generally to catheters, systems, and methods for use in a lumen; and more particularly to catheters, systems, and methods useful in a lumen of the cardiovasculature system.
BACKGROUND OF THE INVENTION
Diseases of the heart valves are grouped according to which valve(s) are involved and the amount of blood flow that is disrupted. The most common valve problems occur in the mitral and aortic valves. Diseases of the tricuspid and pulmonary valves are fairly rare.
The aortic valve regulates the blood flow from the heart's left ventricle into the aorta. The aorta is the main vessel that supplies oxygenated blood to the rest of the body. Diseases of the aorta can have a significant impact on an individual. Examples of such diseases include aortic regurgitation and aortic stenosis.
Aortic regurgitation is also called aortic insufficiency or aortic incompetence. It is a condition in which blood flows backward from a widened or weakened aortic valve into the left ventricle of the heart. In its most serious form, aortic regurgitation is caused by an infection that leaves holes in the valve leaflets. Symptoms of aortic regurgitation may not appear for years. When symptoms do appear, it is because the left ventricle must work harder as compared to an uncompromised ventricle to make up for the backflow of blood. The ventricle eventually gets larger and fluid backs up.
Aortic stenosis is a narrowing or blockage of the aortic valve. Aortic stenosis occurs when the valve leaflets of the aorta become coated with deposits. The deposits change the shape of the leaflets and reduce blood flow through the valve. The left ventricle has to work harder as compared to an uncompromised ventricle to make up for the reduced blood flow. Over time, the extra work can weaken the heart muscle.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 illustrates an embodiment of a catheter in perspective view having partial sectional views to show detail.
FIG. 2 illustrates an embodiment of a catheter in perspective view having partial sectional views to show detail.
FIG. 3 illustrates the embodiment of the catheter of FIG. 2 in a sectional view taken along line 3-3 in FIG. 2.
FIG. 4 illustrates an embodiment of an apparatus in perspective view having partial sectional views to show detail.
FIG. 5 illustrates an embodiment of a system including a catheter and an apparatus in perspective view having partial sectional views to show detail.



DETAILED DESCRIPTION
Embodiments of the present invention are directed to catheters, systems, and methods for valve repair, replacement and/or augmentation using a minimally-invasive technique. Embodiments of the present invention include an apparatus having a catheter that includes cutting heads for preparing cardiac tissue to receive a cardiac valve. Embodiments of the apparatus can further include an expandable stent positioned over at least a portion of an inflatable balloon on the catheter, where the expandable stent can be deployed over cardiac tissue sheared with the cutting heads.
In an additional embodiment, the catheter can further include the cardiac valve and an expandable filter positioned within a sheath, where retracting the sheath deploys the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent. The embodiments of the present invention can, in one example, be used during valve replacement in individuals having heart valve disease.
The Figures herein follow a numbering convention in which the first digit or digits correspond to the drawing Figure number and the remaining digits identify an element or component in the drawing. Similar elements or components between different Figures may be identified by the use of similar digits. For example, 110 may reference element “10” in FIG. 1, and a similar element may be referenced as 210 in FIG. 2. As will be appreciated, elements shown in the various embodiments herein can be added, exchanged, and/or eliminated so as to provide any number of additional embodiments of valve. In addition, the elements shown in the various embodiments are not necessarily to scale.
The Figures presented herein provided illustrations of non-limiting embodiments of the present invention. For example, FIG. 1 provides an illustration of a catheter 100. Catheter 100 includes an elongate body 102 having a first lumen 104 extending between a proximal end 106 and a distal end 108 of the elongate body 102. In one embodiment, the first lumen 104 allows for additional elongate members to travel along a longitudinal axis of the elongate body 102.
The catheter 100 further includes a first cutting head 110 having a blade 112 and an elongate pulling member 114. The first cutting head 110 can be positioned proximal the distal end 108 of the elongate body 102 with the elongate pulling member 114 extending through the first lumen 104. In one embodiment, the elongate pulling member 114 can slide within the first lumen 104 to move the first cutting head 110 relative the distal end 108 of the elongate body 102.
The catheter 100 also includes a second cutting head 116 having a blade 118. The second cutting head 116 can be positioned adjacent the distal end 108 of the elongate body 102 between the distal end 108 and the first cutting head 110. The blade 112 of the first cutting head 110 can move relative the blade 118 of the second cutting head 116 to provide a shearing action. In one example, the shearing action can be sufficient for cutting cardiac tissue.
FIG. 1 further illustrates an embodiment in which the second cutting head includes an elongate pushing member 120. In one embodiment, the elongate pushing member 120 can slide within the first lumen 104 to move the second cutting head 116 relative the distal end 108 of the elongate body 102 and the first cutting head 110. In one embodiment, the elongate pulling member 120 can be arranged concentrically with the elongate pushing member 114 in the first lumen 104.
As illustrated, the elongate pulling member 114, the elongate push member 120 and the first lumen 104 of the elongate body 102 can be positioned coaxially. In one embodiment, the lumen 104 has a diameter sufficient to accommodate the elongate push member 120. Similarly, the elongate push member 120 had a diameter sufficient to accommodate the elongate pulling member 114.
In addition, the elongate pulling member 114 and the elongate push member 120 can be structured such that their relative rotational movement is restricted. In other words, relative axial rotation of the elongate pulling member 114 and the elongate push member 120 is restricted due to the structure of the members 114 and 120. For example, this can be accomplished using one or more physical structures formed in and/or attached to the members 114 and 120. In one embodiment, one of the members 114 or 120 can include a channel through which an extension from the other of the members 114 or 120 can travel so as to inhibit axial rotation of the members 114 and 120. Alternatively, the members 114 and 120 could have a cross-sectional shape that inhibits relative axial rotation. Examples of such cross-sectional shapes include oval or elliptical cross-sectional shapes. Other shapes are also possible.
In addition to providing a sufficient diameter, a gap can exist between the opposing surfaces of the first lumen 104 and the elongate push member 120 to allow the elongate push member 120 to move through the first lumen 104 from force applied at the proximal end of the elongate push member 120. Similarly, a gap can exist between the opposing surfaces of the elongate push member 120 and the elongate pulling member 114 to allow the elongate push member 120 and the elongate pulling member 114 to move relative each other from force applied at the proximal end of the elongate push member 120 and/or the elongate pulling member 114. The elongate pull member 114 can further include a lumen for tracking over a guidewire. A lubricant can be included on the surfaces of the elongate pulling member 114, the elongate push member 120 and the first lumen 104.
The first cutting head 110 further includes a shape conducive to passing the catheter 100 to pass through a lumen (e.g., a lumen of the cardiovascular system). For example, the first cutting head 110 can include a conical shape having a first end 122 and a second end 124, where the first end 122 has a diameter that is less than a diameter of the second end 124. Other shapes are also possible. In addition, the shape of the first cutting head 110 can be configured to protectively house the blade 112 from structures passing by the first end 122 towards the second end 124. In other words, the shape of the first cutting head 110 can be used to shield the blade 112 from unintentionally interfering and/or cutting tissue within a lumen.
In one embodiment, the blade 112 can be radially positioned relative the elongate pulling member 114 generally along the second end 124 of the first cutting head 110. As will be appreciated, the first cutting head 110 can include more than one blade 112 as illustrated in FIG. 1. Each blade 112 and 118 further includes a cutting edge 126 and 128, respectively, in alignment so as to provide shearing action between a pair of the cutting edges 126 and 128 of the blades 112 and 118. For example, the first cutting head 110 can move relative the second cutting head 116 to allow the cutting edge 126 of the blade 112 of the first cutting head 110 to slide past the cutting edge 128 of the blade 116 of the second cutting head 116. Example of suitable materials for the blades 112 and 118 include, but are not limited to, stainless steel (e.g., 316L) and titanium.
In one embodiment, blades 112 and 118 can be secured to the first cutting head 110 and the second cutting head 116, respectively, in any number of ways. For example, blades 112 and 118 can be secured to the cutting heads 110 and 112 through the use of mechanical fasteners, such as screws, and/or interlocking pins and sockets. In addition, blades 112 and 118 can be secured to the cutting heads 110 and 112 through the use of chemical adhesives. Examples of such chemical adhesives include, but are not limited to, medical grade adhesives such as cyanoacrylate, acrylic, silicone, and urethane adhesives.
In an additional embodiment, the first cutting head 110 can be configured to receive and house at least a portion of the second cutting head 116, including the blade 118, such that the second blade 118 does not pass beyond the first cutting head 110. For example, the first cutting head can include a socket that extends radially relative the elongate pulling member 114 and distally from the blade 112 to receive the blade 118 of the second cutting head 116 as the blade 118 passes the blade 112. In one embodiment, the blade 118 can be positioned within the socket of the first cutting head 110 as the catheter 100 is moved through a lumen.
Catheter 100 can have various lengths between the proximal end 106 and the first cutting head 110. In one embodiment, the length between the proximal end 106 and the first cutting head 110 would be sufficient to allow the catheter 100 to be percutaneously implanted through a patient's vasculature to position the cutting heads (e.g., the first and second cutting heads) at a predetermined location. Examples of the predetermined locations include, but are not limited to, cardiovascular locations such as on or adjacent to a cardiac valve of the heart (e.g., the aortic valve), including within a chamber of the patient's heart (e.g., the left ventricle of the heart). As will be appreciated, the length between the proximal end 106 and the first cutting head 110 will be dependent upon each patient's physiological structure and the predetermined location within the patient. By way of example only, the length between the proximal end 106 and the first cutting head 110 could be up to, and including, approximately 100 cm. Lengths greater than 100 cm are also possible.
The elongate body 102, the elongate pulling member 114, the elongate pushing member 120, the second cutting head 116 and the first cutting head 110 can be formed from a wide variety of materials and in a wide variety of configurations. For example, the materials may include, but are not limited to, one or more of polyvinyl chloride (PVC), polyethylene (PE), polyolefin copolymer (POC), polyethylene terephthalate (PET), polyamid, mixtures, and block co-polymers thereof. Alternatively, the materials may include one or more alloys in any number of configurations. For example, the materials may include stainless steel (e.g., 316L), titanium, or other medical grade alloys as are known. These materials may also have a woven configuration or a solid extruded configuration.
The selection of material and configuration allows for the elongate body 102, the elongate pulling member 114, the elongate pushing member 120, the second cutting head 116 and the first cutting head 110 to each have the flexibility, and the ability to be either pushed and/or pulled thereby accomplishing the actions described for the components herein. As will be appreciated, selection of the material can be based generally on a broad range of technical properties, including, but not limited to, modulus of elasticity, flexural modulus, and Shore A hardness required for the embodiments of the present invention. Components of the present apparatus and/or system can also be coated for lubrication, for abrasion resistance, or to deliver an anticoagulatory drug.
In an additional embodiment, the catheter 100 can further include radiopaque markers 130. For example, radiopaque markers (e.g., attached or coated) can be used to mark the location of the first cutting head 110 and the second cutting head 116. In addition, radiopaque markers can be used to mark the location of blades 112 and 118. Other portions of catheter 100 can also be marked with radiopaque markers as necessary to allow for visualization of the location and position of parts of the catheter 100. Examples of radiopaque material include, but are not limited to, gold, tantalum, and platinum.
FIG. 2 provides an illustration of a catheter 200 according to an additional embodiment of the present invention. Catheter 200 includes elongate body 202 having the first lumen 204 extending between the proximal end 206 and the distal end 208 of the elongate body 202. In addition, catheter 200 includes the first cutting head 210 and the second cutting head 216 as described herein.
In addition to the structures described herein, the elongate body 202 of catheter 200 further includes a second lumen 234. In one embodiment, the second lumen 234 can extend between the proximal end 206 and the distal end 208 of the elongate body 202, where the second lumen 234 can be coupled in fluid tight communication to an inflatable balloon 236 on the elongate body 202.
In one embodiment, the inflatable balloon 236 can be positioned adjacent the distal end 208 of the elongate body 202 and proximal to the second cutting head 216. The inflatable balloon 236 can be inflated from a deflated state to an inflated state by pressure applied by fluid moving through the second lumen 234. In addition, the catheter 200 further includes an expandable stent 238 positioned over at least a portion of the inflatable balloon 236. The expandable stent 238 can move between a compressed state, as shown in FIG. 2, and an expanded state using the inflatable balloon 236. In one embodiment, the expandable stent 238 can be deployed over cardiac tissue sheared using the first and second cutting heads 210 and 216 using the inflatable balloon 236.
Catheter 200 can further include an annular push ring 240 positioned between the second cutting head 216 and the inflatable balloon 236. The annular push ring 240 can be used for contacting and moving at least a portion of cardiac tissue sheared with the first and second cutting heads 210 and 216. For example, the first and second cutting heads 210 and 216 can be used to shear cardiac tissue (e.g., one or more cusps of a valve). The annular push ring 240 can then be advanced into contact with the sheared cardiac tissue. As the annular push ring 240 advances the sheared cardiac tissue can be directed towards the wall of the lumen. Stent 238 can then be positioned over at least a portion of the sheared cardiac tissue positioned using the annular push ring 240. Stent 238 can then be deployed using the inflatable balloon 236 to position at least a portion of the sheared cardiac tissue between the expanded stent 238 and the wall of the lumen. As will be appreciated, the dimensions and physical characteristics of the stent 238 will be dependent upon the location in which the stent 238 is to be implanted.
In an additional embodiment, the annular push ring 240 can be radially expandable. For example, the annular push ring 240 can be configured as an expandable balloon in fluid tight communication with the second lumen 234. In one embodiment, the fluid pressure necessary to inflate the annular push ring 240 in its expandable balloon configuration is less than that necessary to inflate the inflatable balloon 236. In this way, a lesser fluid pressure applied through the second lumen 234 can be used to first inflate the annular push ring 240, with additional fluid pressure applied through the second lumen 234 then used to inflate the inflatable balloon 236 to deploy the expanded stent 238 as discussed. In an alternative embodiment, a separate fluid lumen could be coupled in fluid communication with the expandable annular push ring 240. As will be appreciated, the annular push ring 240 can be formed of any number of suitable materials (e.g., metal, polymer, and composite), including those provided herein. In addition, other configurations for allowing the annular push ring 240 to expand (e.g., radially expand) are also possible.
FIG. 3 provides a cross-sectional view of the catheter 300 taken along lines 3-3 in FIG. 2.
FIG. 4 provides an illustration of an apparatus 444 that can be used in conjunction with the catheter 100/200. In one embodiment, apparatus 444 includes a sheath 446 having a lumen 448. The sheath 446 includes a first sheath end 450 and a second sheath end 452. In one embodiment, at least part of the elongate body 102/202 can reside in the lumen 448 of the sheath 446, as will be illustrated herein.
The apparatus 444 can further include a cardiac valve 454. The cardiac valve 454 can be releasably positioned within the lumen 448 of the sheath 446. Generally, valve 454 can be implanted within the fluid passageway of a body lumen, such as for replacement of a valve structure within the body lumen (e.g., a venous valve), to regulate the flow of a bodily fluid through the body lumen in a single direction.
With respect to the apparatus 444, the cardiac valve 454 can be configured to reside in a compressed state within the lumen 448 of the apparatus 444. When released from the lumen 448, the cardiac valve 454 expands into a deployed state as illustrated in FIG. 4. In one embodiment, the cardiac valve 454 expands from its compressed state within the lumen 448 to the deployed state when the sheath 446 is retracted from around the valve 454.
The cardiac valve 454 further includes a support frame 456 and a cover 458. The support frame 456 can include an outer surface 460, an inner surface 462 defining a lumen 464. The configuration of the support frame 456 provides the valve 454 with sufficient flexibility to move between the compressed and the deployed states.
The cover 458 of the cardiac valve 454 can be positioned over at least the outer surface 460 of the support frame 456. In one embodiment, the cover 458 includes surfaces 466 defining a reversibly sealable opening 468 for unidirectional flow of a liquid through the lumen 464 of the cardiac valve 454. For example, surfaces of the cover 458 can be deflectable between a closed configuration in which fluid flow through the lumen 464 can be restricted and an open configuration in which fluid flow through the lumen 464 can be permitted. One example of cardiac valve 446 includes those described in U.S. Patent application Ser. No. 11/052,655 entitled “Venous Valve Apparatus, System, and Method”, which is incorporated herein by reference in its entirety.
The support frame 456 can be formed from any number of materials. For example, the support frame 456 can be formed from a biocompatible metal, metal alloy, polymeric material, or combination thereof. Examples of suitable materials include, but are not limited to, medical grade stainless steel (e.g., 316L), titanium, tantalum, platinum alloys, niobium alloys, cobalt alloys, alginate, or combinations thereof. In an additional embodiment, the support frame 456 may be formed from a shape-memory material, such as shape memory plastics, polymers, and thermoplastic materials which are inert in the body. Shaped memory alloys having superelastic properties generally made from specific ratios of nickel and titanium, commonly known as nitinol, are also possible materials. Other materials are also possible.
In one embodiment, the material of the cover 458 can be constructed of a fluid-impermeable biocompatible material that can be either synthetic or biologic. Possible synthetic materials include, but are not limited to, expanded polytetrafluoroethylene (ePTFE), polytetrafluoroethylene (PTFE), polystyrene-polyisobutylene-polystyrene (SIBS), polyurethane, segmented poly(carbonate-urethane), Dacron, polyethlylene (PE), polyethylene terephthalate (PET), silk, urethane, Rayon, Silicone, or the like. Possible biologic materials include, but are not limited to, autologous, allogeneic or xenograft material. These include explanted veins and decellularized basement membrane materials, such as small intestine submucosa (SIS) or umbilical vein.
The support frame 456 of the cardiac valve 454 expands to increase a diameter of the lumen 464 as the sheath 446 moves relative the cardiac valve 454 and an expandable filter 470 to deploy the cardiac valve 454. In one embodiment, the size of lumen 464 can be determined based upon the type of body lumen and the body lumen size in which the valve 454 is to be placed. In an additional example, there can also be a minimum value for the width for the support frame 456 that ensures that the valve 454 will have an appropriate expansion force against the inner wall of the body lumen to encourage fixation of the valve 454 and to prevent retrograde flow within the body lumen. Anchoring elements (e.g., barbs) can also be included on the support frame 456 of the valve 454.
The apparatus can further include the expandable filter 470 positioned within the lumen 448 of the sheath 446. In one embodiment, the expandable filter 470 can be positioned coaxially with the sheath 446. The expandable filter 470 includes a first filter end 472 adjacent the first sheath end 450. In one embodiment, the first filter end 472 has a first diameter when positioned between the sheath 446 that expands to a second diameter when the sheath 446 moves along a longitudinal axis relative the cardiac valve 454 and the expandable filter 470 to deploy the cardiac valve 454 and at least the first filter end 472. FIG. 4 provides an illustration of sheath 446 having been retracted to deploy the cardiac valve 454 and at least partially deploy the expandable filter 470.
In one embodiment, the expandable filter 470 radially self-expands as the sheath 446 is retracted. For example, the expandable filter 470 can be configured to expand from a compressed state within the lumen 448 of the sheath 446 into an expanded state as the sheath 446 is retracted from the expandable filter 470. The expandable filter 470 in its deployed state can fill the cross-section area of the lumen in which the expandable filter 470 is deployed. In addition, filter 470 in its deployed state can apply sufficient pressure to the inner wall of the lumen to reduce the volume of fluid (e.g., blood) that may pass between the filter 470 and the surface of the lumen wall. As will be appreciated, the area and shape defined by the expandable filter 470 (e.g., the diameter of the expandable filter) in its deployed state will be dependent upon the location in which the apparatus is intended to be used.
The first filter end 472 can also be configured to extend proximally and distally in a curvilinear manner (i.e., a multi-lobe configuration) to accommodate the valve 454 configuration and the dissected valve anatomy. In addition, this first filter end 472 configuration may also allow filter protection of the cononary ostia while maximizing working area for valve repair or replacement.
Examples of radially self-expanding filters include those formed from temperature-sensitive memory alloy which changes shape at a designated temperature or temperature range. Examples of such materials include, but are not limited to, nitinol and nitinol-type metal alloys. Alternatively, self-expanding filters can include those having a spring-bias imparted into the members forming the filter 470. The expandable filter 470 can have a woven and/or a knit configuration that can also impart a self-expanding aspect to the expandable filter 470. The expandable filter 470 can also include a self-expanding component in addition to more passive porous filtering material which controls filtering size while the self-expanding component provides the deployment motion. Such filtering material can be, for example, woven, braided, knit, machined, matted, expanded, or other configurations as are known, or will be known, in polymer and textile processing.
The apparatus 444 further includes a retention line 474 releasably coupled to the support frame 456. The retention line 474 extends from the cardiac valve 454 through the lumen 448 of the sheath 446. In one embodiment, the retention line 474 can be used to move the cardiac valve 454. For example, the retention line 474 can extend through the lumen 448 past a proximal end of the sheath 446 where the line 474 can be used to draw the cardiac valve 454 at least partially back into its compressed state within the lumen 448 of the sheath 446. Alternatively, the retention line 474 can be used to change the position of the cardiac valve 454 once deployed from a first position within the lumen to a second position. The retention line 474 can be optionally removed from the valve 454 by drawing one end of the line 474 through the valve 454.
The sheath 446 can be formed of a number of materials. Materials include polymers, such as PVC, PE, POC, PET, polyamid, mixtures, and block co-polymers thereof. In addition, the sheath 446 can have a wall thickness and an inner diameter sufficient to maintain both the cardiac valve 454 and the expandable filter 470 in compressed states when they are positioned within the lumen 448.
The apparatus 444 can further include handles positioned at a proximal end 376 of the sheath 446 and the expandable filter 470. In one embodiment, the sheath 446 includes a handle 478 and the expandable filter 464 includes a handle 480. Handles 478 and 480 allow the sheath 446 to be retracted from the proximal end 476 to expose and expand the valve 454 and at least a part of filter 470. In one embodiment, the distance between the handles 478 and 480 can correspond approximately to the length of the compacted cardiac valve 454 and at least a portion of the filter 470.
In an additional embodiment, the apparatus 440 can further include a sleeve 482 having a slit 484 and a pull tab 486 positioned between the handles during delivery to prevent inadvertent exposure of the cardiac valve 454 and filter 470 (FIG. 5). For example, the sleeve 482 can be stripped from the apparatus 440 once the apparatus 440 has been placed at the predetermined location at which the cardiac valve 446 and the filter 464 are to be deployed. Other removable structures for preventing inadvertent exposure of the cardiac valve 454 and filter 470 are also possible.
In an additional embodiment, the apparatus 444 can further include radiopaque markers 490. For example, radiopaque markers (e.g., attached or coated) can be used to mark the location of the cardiac valve 454 and/or the expandable filter 470. Other portions of catheter apparatus 444 can also be marked with radiopaque markers as necessary to allow for visualization of the location and position of parts of the apparatus 444.
FIG. 5 provides an illustration of one embodiment of a system 590 that include both the catheter 500 and the apparatus 544. As illustrated in FIG. 5, the elongate body 502 of catheter 500 can be positioned at least partially within the lumen 548 of the sheath 546. In one embodiment, the elongate body 502 passes through and can move longitudinally within the lumen of the expandable filter 570 and the reversibly sealable opening 568 of the cardiac valve 554.
In an additional embodiment, the first sheath end 550 can be positioned between the inflatable balloon 536 and the second sheath end 576. As discussed, the sheath 546 can be moved relative the cardiac valve 554 and the expandable filter 570 to deploy the cardiac valve 554 and at least a portion of the expandable filter 570 proximal the inflatable balloon 536 and the expandable stent 538. The system 590 further includes an inflation device 594 that can reversibly couple in fluid tight communication with the second lumen 534 to provide fluid pressure to inflate and deflate balloon 536. After the procedure, the expandable filter 570 can be withdrawn together with any captured debris.
The embodiments of the present invention further include methods for forming the catheters, apparatus and systems, as discussed herein. For example, embodiments of the catheters of the present invention can be formed by providing an elongate body having a first lumen and a second lumen extending between the proximal end and the distal end of the elongate body. The first cutting head with its blade can then be positioned proximal the distal end of the elongate body. In one embodiment, the first cutting head includes the elongate pulling member positioned within the first lumen of the elongate body. The elongate pulling member extends through the first lumen such that the elongate pulling member can slide within the first lumen to move the first cutting head relative the distal end of the elongate body.
The catheter can further include the second cutting head having its blade positioned adjacent the distal end of the elongate body between the distal end and the first cutting head. In one embodiment, the second cutting head includes the elongate pushing member extending through the first lumen such that the elongate pushing member can slide within the first lumen to move the second cutting head relative the distal end of the elongate body and the first cutting head. As discussed herein, the blades of the first cutting head and the second cutting head move relative each other to provide the shearing action.
The catheter can also include the inflatable balloon positioned adjacent the distal end of the elongate body and proximal to the second cutting head. The expandable balloon member can be in fluid tight communication with the second lumen. The expandable stent can then be positioned over at least a portion of the inflatable balloon. In an additional embodiment, the catheter can further include positioning the annular push ring between the second cutting head and the inflatable balloon of the catheter.
The embodiments of the catheter can also be combined with the embodiments of the apparatus to form embodiments of the system of the present invention. For example, embodiments of the apparatus can be formed by positioning both the expandable filter and the cardiac valve in the lumen of the sheath, as illustrated herein. The lumen of the sheath can then also be positioned over and adjacent to at least part of the elongate body. The sheath can then move relative the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter proximal the inflatable balloon and the expandable stent.
The embodiments of the catheter, apparatus and system described herein may be used to replace, supplement, or augment valve structures within one or more lumens of the body. For example, embodiments of the present invention may be used to replace an incompetent cardiac valve of the heart, such as the aortic, pulmonary and/or mitral valve of the heart.
In one embodiment, the method of replacing, supplementing, and/or augmenting a valve structure can include positioning at least part of the catheter of the system at a predetermined location within an artery of a patient, such as in the aorta adjacent the root of the aortic valve. In positioning the catheter, first and second cutting heads can be positioned with the cardiac valve leaflets (e.g., leaflets of and aortic valve) between the blades of the cutting heads.
The sheath of the apparatus can then be retracted so as to deploy both the cardiac valve and the expandable filter. The cutting heads can then be used to shear the cardiac tissue of the valve leaflets. The catheter can then be advance so that the annular push ring contacts and directs the sheared cardiac tissue in the same direction. The stent can then be deployed over the sheared cardiac tissue (e.g., the sheared aortic leaflets) to position them between the stent and the wall of the lumen. The retention lines can then be withdrawn, along with the expandable filter through the lumen of the sheath. Finally, the deflated balloon, annular push ring, and cutting heads of the catheter can be drawn through the lumen of the expanded cardiac valve and out of the lumen.
In one embodiment, positioning the system within the body lumen includes introducing the system into the cardiovascular system of the patient using minimally invasive percutaneous, transluminal catheter based delivery system, as is known in the art. For example, a guidewire can be positioned within the cardiovascular system of a patient that includes the predetermined location. The system (e.g., apparatus and catheter) can be positioned over the guidewire and the system advanced so as to position the cutting heads, stent, and valve on or adjacent to the predetermined location. In one embodiment, radiopaque markers on the various elements of the system, as described herein, can be used to help locate and position the system.
Both the stent and the valve can be deployed from the system at the predetermined location in any number of ways, as described herein. In one embodiment, the stent and the valve of the present invention can be deployed and placed in any number of cardiovascular locations. For example, the stent and the valve can be deployed and placed within a major artery of a patient. In one embodiment, major arteries include, but are not limited to, the aorta. In addition, valves of the present invention can be deployed and placed within other major arteries of the heart and/or within the heart itself, such as in pulmonary artery for replacement and/or augmentation of the pulmonary valve and between the left atrium and the left ventricle for replacement and/or augmentation of the mitral valve. Other locations are also possible.
Once implanted, the valve can provide sufficient contact and expansion force against the body lumen wall to prevent retrograde flow between the valve and the body lumen wall. For example, the valve can be selected to have a larger expansion diameter than the diameter of the inner wall of the body lumen. This can then allow the valve to exert a force on the body lumen wall and accommodate changes in the body lumen diameter, while maintaining the proper placement of the valve. As described herein, the valve can engage the lumen so as to reduce the volume of retrograde flow through and around the valve. It is, however, understood that some leaking or fluid flow may occur between the valve and the body lumen and/or through the valve leaflets.
While the present invention has been shown and described in detail above, it will be clear to the person skilled in the art that changes and modifications may be made without departing from the spirit and scope of the invention. As such, that which is set forth in the foregoing description and accompanying drawings is offered by way of illustration only and not as a limitation. The actual scope of the invention is intended to be defined by the following claims, along with the full range of equivalents to which such claims are entitled.
In addition, one of ordinary skill in the art will appreciate upon reading and understanding this disclosure that other variations for the invention described herein can be included within the scope of the present invention. For example, the stent 238, support frame 356 and/or the cover 358 can be coated with a non-thrombogenic biocompatible material, as are known or will be known.
In the foregoing Detailed Description, various features are grouped together in several embodiments for the purpose of streamlining the disclosure. This method of disclosure is not to be interpreted as reflecting an intention that the embodiments of the invention require more features than are expressly recited in each claim. Rather, as the following claims reflect, inventive subject matter lies in less than all features of a single disclosed embodiment. Thus, the following claims are hereby incorporated into the Detailed Description, with each claim standing on its own as a separate embodiment.

## Claims

1. A system, comprising:
an elongate catheter body having a first lumen and a second lumen extending between a proximal end and a distal end of the elongate catheter body;
a first cutting head having a blade and an elongate pulling member, the elongate pulling member extends through the first lumen and slides within the first lumen to move the first cutting head relative to the distal end of the elongate catheter body;
a second cutting head having a blade, the second cutting head positioned adjacent to the distal end of the elongate catheter body between the distal end and the first cutting head;
an inflatable balloon positioned adjacent to the distal end of the elongate catheter body and proximal to the second cutting head, the inflatable balloon in fluid tight communication with the second lumen;
an expandable stent positioned over at least a portion of the inflatable balloon, where the blade of the first cutting head moves relative to the blade of the second cutting head to provide a shearing action for cardiac tissue and the inflatable balloon deploys the expandable stent over sheared cardiac tissue; and
an expandable filter positioned within a lumen of a sheath and proximal to a cardiac valve, wherein the elongate catheter body is positioned at least partially within the lumen of the sheath, and wherein the sheath moves relative to the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter and wherein both the cardiac valve and the expandable filter are positioned toward the proximal end relative to the inflatable balloon and the expandable stent.

2. The system of claim 1, wherein the first cutting head includes a first end and a second end, the second end having the blade with a cutting edge, and wherein the second cutting head includes the blade with a cutting edge in alignment with the cutting edge of the blade of the first cutting head, the first cutting head moving relative to the second cutting head to slide the first cutting edge past the second cutting edge.

3. The system of claim 2, wherein the first cutting head has a conical shape with the first end having a diameter less than the second end.

4. The system of claim 1, the second cutting head further including an elongate pushing member, wherein elongate pushing member slides within the first lumen to move the second cutting head relative to the distal end of the elongate body and the first cutting head, the elongate pulling member arranged concentrically with the elongate pushing member in the first lumen.

5. The system of claim 1, further including an annular push ring positioned between the second cutting head and the inflatable balloon for contacting and moving at least a portion of the sheared cardiac tissue.

6. The system of claim 1, wherein a support frame of the cardiac valve expands to increase a diameter of a lumen defined by the cardiac valve as the sheath moves relative to the cardiac valve and the expandable filter to deploy the cardiac valve.

7. The system of claim 1, further including a retention line releasably coupled to the support frame, wherein the retention line extends through the lumen of the sheath past the proximal end of the elongate body.

8. The system of claim 1, wherein the sheath includes a first sheath end and a second sheath end, the first sheath end positioned between the inflatable balloon and the second sheath end, and wherein the expandable filter includes a first filter end adjacent the first sheath end, the first filter end having a first diameter when positioned between the sheath and the elongate body that expands to a second diameter when the sheath moves relative the cardiac valve and the expandable filter to deploy at least the first filter end.

9. A system, comprising:
an elongate catheter body having a first lumen and a second lumen extending between a proximal end and a distal end of the elongate catheter body;
a first cutting head having a blade and an elongate pulling member, wherein the elongate pulling member extends through the first lumen and slides within the first lumen to move the first cutting head relative to the distal end of the elongate catheter body;
a second cutting head having a blade, the second cutting head positioned adjacent to the distal end of the elongate catheter body between the distal end and the first cutting head; and
an expandable filter positioned within a lumen of a sheath proximal to a cardiac valve, wherein the elongate catheter body is positioned at least partially within the lumen of the sheath, and wherein the sheath moves relative to the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter and wherein both the cardiac valve and the expandable filter are positioned toward the proximal end relative to an inflatable balloon and an expandable stent.

10. A system, comprising:
an elongate catheter body having a first lumen and a second lumen extending between a proximal end and a distal end of the elongate catheter body;
a first cutting head having a blade and an elongate pulling member wherein the elongate pulling member extends through the first lumen and slides within the first lumen to move the first cutting head relative to the distal end of the elongate catheter body;
a second cutting head having a blade, the second cutting head positioned adjacent to the distal end of the elongate catheter body between the distal end and the first cutting head; and
an expandable filter positioned within a lumen of a sheath and proximal to a cardiac valve, wherein the elongate catheter body is positioned at least partially within the lumen of the sheath, and where the cardiac valve is releasably positioned within the lumen of the sheath and the elongate catheter body extends through a lumen of the cardiac valve, wherein the sheath can move relative to the cardiac valve and the expandable filter to deploy the cardiac valve and at least a portion of the expandable filter and where both the cardiac valve and the expandable filter are positioned toward the proximal end relative to an inflatable balloon positioned adjacent the distal end of the elongate catheter body and proximal to the second cutting head and an expandable stent.