Multi-wire catheter device

Abstract

A device for locating openings and / or detecting the shape and curve of a wall or cavity within the body, may comprise using a catheter containing an array of multiple wires packed into the catheter to probe the area in the body by maneuvering the ends of the multiple wires over the area, the ends of the multiple wires being exposed through an open end in the catheter. This may be used to determining a state and / or location of one or more wires via sensor(s) in the wires and / or imaging techniques utilizing a radio-opaqueness or other electromagnetic opaqueness of the wires.

Description

MULTI-WIRE CATHETER DEVICECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to US Provisional Application No. 63 / 688,010 filed August 28, 2024, titled “Multi-Wire Catheter Device’', the disclosure of which is herein fully incorporated by reference.FIELD

[0002] This disclosure generally relates to devices and methods that may be useful for engaging with target structures in the body. For example, the devices herein may be configured to assist a surgeon when performing a procedure requiring insertion of a guide wire, catheter, or other device through a valve.BACKGROUND

[0003] This section is intended to provide a background or context to the invention that is recited in the claims. The description herein may include concepts that could be pursued but are not necessarily ones that have been previously conceived or pursued. Therefore, unless otherwise indicated herein, what is described in this section is not admitted to be prior art to the description and claims by inclusion in this section.

[0004] Current techniques for locating an opening within the body may utilize a guide wire delivered through a catheter. For example, it may be important to locate a valve (e.g., the aortic valve or mitral valve) so that a guide wire may be inserted therethrough. This may, for example, be useful in procedures for treating valve stenosis including, for example, valve replacement procedures. Generally, cunent practice for inserting a guide wire through a valve are imprecise and may involve repeated attempts, resulting in prolonged surgeries. These repeated attempts and the associated risks related to their execution may be particularly acute when the catheter is angled in some unexpected way or when it is difficult to maneuver the device through irregular or partially obstructed anatomy. In some cases, several different images may need to be taken to venfy proper positioning of a guide wire. Attempts to move a guide wire through the valve may also carry some attendant risk of dislodging material (e.g., calcified matter) from the valve or adjacent vessels so that the procedure also carries risk offurther complication including stroke.

[0005] In light of the above considerations, there is a need for improved devices and methods for positioning and moving catheters, guide wires, and related components. Particularly, there is a need for reliable devices and related methods useful for locating structures in the body and for engaging those structures to accomplish difficult actions such as remotely inserting a wire through a valve. Embodiments of devices, components, and methods described herein address the aforementioned needs and other needs as described herein.SUMMARY

[0006] According to various embodiments, disclosed is a device for locating openings and / or detecting the shape and curve of a wall or cavity within the body using a catheter containing an array of multiple wires which are packed into the catheter. For example, the multiple wires may be disposed in the catheter in a packed state. In some embodiments, the catheter may be guided to an area of interest within the body, the area is then probed by maneuvering the ends of the multiple wires over the area, wherein the ends of the multiple wires are exposed through an open end in the catheter. The shape of the area and / or any openings in the area may then be discovered by determining a state and / or location of one or more wires via sensor(s) in the wires and / or via imaging techniques utilizing an electromagnetic opaqueness (e.g.. a radio-opaqueness) of the wires, or via movement or inspection of the ends of the wires extending from the end of the catheter held by a surgeon.

[0007] In some embodiments, a device may comprise a housing (e.g., a catheter, sleeve, or sheath) enclosing an array of multiple wires, the wires being packed within the housing in a packed configuration and configured so as to deploy from the distal end of the housing to provide a wire bouquet in an expanded state; and a sensor operatively coupled to the array of multiple wires.

[0008] In some embodiments, a device may comprise a housing containing a wire assembly packed within the housing in a packed configuration and configured so as to deploy from the distal end of the housing to provide a wire basket forming an interior in an expanded state; and a wire array, the wire array being configured for extension through said interior of the wire basket.

[0009] In some embodiments, a device may be configured for engagement with an aortic valve of the human body, the device comprising: a housing containing a wire assembly disposed therein in a packed configuration and configured so as to deploy from the distal endof the housing to provide a wire basket forming an interior in an expanded state, the wire basket comprising a plurality of legs and a hoop, the hoop being secured to the plurality of legs and sized for engagement with the aortic valve or adj acent anatomy; and a wire array, the wire array being configured for extension through an interior of the wire basket.

[0010] In some embodiments, a device may comprise a housing supporting a wire assembly in a packed configuration, the wire assembly comprising a plurality of wires configured for deployment in an expanded state when the housing is retracted; and a multiwire hole finder comprising: a second housing; and a plurality of wires packed within the second housing, an individual wire among the plurality of wires being configured for extension through a space bounded by the wire assembly in its expanded state.BRIEF DESCRIPTION OF THE DRAWINGS

[0011] The detailed description of some embodiments of the invention will be made below with reference to the accompanying figures, wherein the figures disclose one or more embodiments of the present invention.

[0012] FIG. 1 A is a front perspective view of a multi-wire device according to certain embodiments shown in an expanded or deployed state.

[0013] Fig. IB is a front elevational view of the multi-wire device of Fig. 1 A shown in a packed configuration.

[0014] FIG. 2 is a flowchart showing a representative method of using a multiwire device

[0015] FIG. 3 is a front perspective view of a multi-wire device shown positioned near to an opening.

[0016] FIG. 4 is a front perspective view of a multi-wire device shown with an individual wire passing into an opening.

[0017] FIG. 5 is a front perspective view of a multi-wire device shown with an individual wire passing into an opening and with other wires of the device during retraction.

[0018] FIG. 6 is a front perspective view of a multi-wire device shown with an individual wire passing into an opening and extended therethrough.

[0019] FIG. 7 is a perspective view of the multi-wire device comprising a wire bouquet with an optional guide basket.

[0020] FIG. 8 illustrates the guide basket of FIG. 7 centering the wire bouquet in a tubular structure.

[0021] FIG. 9 is a botom perspective view of an alternate embodiment of the multiwire device, which includes a wire array that can mold to create a surface impression.

[0022] FIG. 10 shows the wire array of FIG. 9 imprinting on a surface.

[0023] FIG. 11 is a front perspective view of another representative embodiment of a multi-wire device.

[0024] FIG. 12 shows a flowchart of a representative method of using a multi-wire device.

[0025] FIG. 13 is a perspective view of a guide wire shown positioned adjacent to a valve.

[0026] FIG. 14 is a side view of a representative embodiment of a wire assembly inserted over a guide wire.

[0027] FIG. 15 is a perspective view of a multi-wire device shown positioned adjacent to a valve and in a deployed configuration.

[0028] FIG. 16 is a side view of multi-wire device shown positioned adjacent to a valve and in a deployed configuration and with a multi -wire hole finder positioned adjacent to the valve.

[0029] FIG. 17 is a side perspective view of a multi-wire device shown positioned adjacent to a valve and with a single wire of a multi-wire hole finder extended through a valve.

[0030] FIG. 18 is a side perspective view of a multi-wire device shown in FIG. 17 with additional wires retracted.

[0031] FIG. 19 is a side view of the multi -wire device show n in FIG. 18 shown with a self-aligning assembly partially retracted through a sheath.

[0032] FIG. 20 is a flowchart showing another representative method for using a multi-wire device.

[0033] FIG. 21 is a side perspective view of a multi -w ire device shown during a stage of insertion of the device through a valve.

[0034] FIG. 22 is a perspective view of a multi-wire device show n during a stage wherein a multi-wire hole finder is retracted.

[0035] FIG. 23 is a perspective view of a multi-wire device shown during a stage of insertion through a valve.

[0036] FIG. 24 is a side perspective view7of a multi-w ire device showor during a stage wherein the device is being retracted.

[0037] FIG. 25 is a front perspective view of another multi-wire catheter device according to certain embodiments shown in an expanded or deployed state.

[0038] FIG. 26 shows a representative embodiment of an attachment or coupling as may be fitted at the distal end of a housing or catheter.

[0039] FIG. 27 shows another representative embodiment of an attachment or coupling including a openings for wires of a tripod.DETAILED DESCRIPTION

[0040] This disclosure is generally directed to medical devices including catheters, guide wires, wire assemblies or arrays, and to related components and methods of use. Generally, the devices 10, 42, 70, 120 described herein may be comprised of multiple wires 16, 18. 48 as may be used to probe a target structure. In some embodiments, the devices herein may further be configured to position multiple wires (e.g., in the form of a multi-wire array or assembly) in a self-aligned way so that the multiple wires are positioned in a desired position and / or orientation with respect to a target structure. For example, as shown in Fig. 11 (see also Figs. 17 & 18). a device 42 may comprise a multi -wire hole finder 44 that is directed through a self-aligned or centered housing or sheath 58 so as to position the hole finder 44 adjacent an orifice of a valve. This positioning may, for example, facilitate locating the valve’s orifice (see Fig. 17) and insertion of a guide wire, catheter, impeller, or other device therethrough, as shown in Fig. 18, for example.

[0041] More generally, the various devices 10, 42, 70. 120 and related components 16. 30, 36, 42 (or other components) described herein may, for example, be used for locating openings in the body, determining structure or structural features, or for other uses. For example, the disclosed devices may be used for diagnostic or therapeutic procedures such as for taking out obstructions, delivering therapy, deploying other devices, for localing / i den ti lying openings in the body (for example in the aortic valve, or coronary sinus ostium), and the like. For example, in some embodiments, wires aligned or positioned using devices and methods described herein may be used to position a replacement valve in a medical procedure or to position an impeller in a canty of the body. In another example, structural features of patient anatomy may be mapped in procedures that may demand crossing between atria or guiding a medical device for engagement with a particular portion of the heart. For example, devices herein (see Fig. 10, for example) may be used to map the atrial septum. Generally, as opposed to a single wire device which provides only a single probing point, some of the devices herein may create a dense multipoint probing area by using multiple wires disposed within a single housing or catheter, for example. In some embodiments, this multi-point probing area may be self-aligned with a targetstructure or valve. Generally, the aforementioned features individually or together may make it easier for a surgeon to engage with the target structure so as to pass a wire or catheter therethrough or to engage with the target structure in some other way.

[0042] The devices described herein may be configured for routing to a target structure. For example, devices described herein may be embodied as catheters that may be used to deliver the devices into the body and route the device to a target structure. For example, devices herein may generally be packed into the interior or lumen of a catheter. In some embodiments, the devices herein may be provided in a different housing such as sleeve or sheath. A housing may generally provide a protective covering for a device. A housing may also serve other functions such as sliding forw ards or backwards through another housing or catheter. Relatedly, a housing may be useful in deployment of devices as described herein. For example, in some embodiments, a housing may include one or more guides, such as may be embodied as slots, grooves, or openings, for example. In some embodiments, a housing, may be configured (e.g., sized and shaped) for routing through the interior or lumen of a catheter. A housing may, for example, be configured so as to hold a multi-wire structure in place during a first part of a medical procedure. The housing may further be configured to be pulled back or disengaged from a multi-wire structure. The act of pulling back or disengaging from the multi-wire structure may allow the multi -wire to deploy in a second part of the medical procedure. In some embodiments, a housing or an attachment coupled thereto may be configured so as to facilitate deployment of a multi-wire structure in a desired way. For example, a housing (e.g., a sleeve or sheath) or an attachment coupled thereto may include one or more grooves, channels, or openings that guide the deployment of multi-wire structures in some embodiments herein.

[0043] Relatedly, in this disclosure, various components of multi-wire devices are described. Generally, those components may be packed into the lumen of a catheter or used with a catheter. In some embodiments, a target structure for a multi-wire device may be a valve, such as the aortic valve or mitral valve, for example. A valve may, for example, be stenotic and targeted for therapy, treatment, or valve replacement, as the case may be. Generally, any of various techniques and components may be used for gaining access to a target valve or other structure. For example, the aortic valve may be accessed through either the radial artery, femoral artery or accessed in some other suitable procedure providing access to the aortic arch. Generally, housings and guide wires described herein may be configured appropriately for a given technique and intended means for accessing a target structure. For example, in some embodiments herein, a catheter may be sized from about 6 Fr units to about 11 Fr units. The catheter may, for example, be configured so as to slide over a suitable guidewire such as a 0.035 inch J-tipped guidewire, for example. A housing or sheath may be coupled thereto and sized at a smaller dimension. For example, in some embodiments, a 4 Fr sheath including a 0.052 inch central lumen may be fed over the guide wire and through the larger sized catheter.

[0044] A catheter may provide a channel or lumen in which device components described herein may be disposed. For example, a catheter may generally comprise a cylindrical outer wall and a channel or lumen enclosed thereby. Components described herein may be packed in the lumen of a catheter - either directly or through an intermediate housing, for example. Some of the components or devices herein may be configured for packing within a catheter or housing in a first or packed configuration. The devices may also be configured for release or deployment into a second or expanded configuration. For example, multiple wires 18 may be packed in a catheter, housing, or sheath in a first or packed configuration or state suitable for high density packing in the lumen of a catheter. The multiple wires 18 may then be unpacked or deployed to provide an expanded state including, for example, a wire bouquet 16 or guide basket 24 as illustrated, respectively, in Fig. IB and Fig. 7. In some embodiments, wires packed within the lumen of a catheter (or other housing) may be made of nitinol. As generally known in the art, nitinol may be formed into an elastic material that may be packaged in one state and return to a memory-shaped form when unpacked. Alternatively, the wires may be comprised of some other suitable material such as stainless steel, for example. Generally, unpacking wires may be accomplished by any suitable means, including, for example, through retracting one or more walls of a catheter or housing, as the case may be. As the wall(s) is / are retracted, wires may be exposed at the distal end thereof.

[0045] In some embodiments, other components may be packed in a catheter or housing along with multiple wires and / or other components described herein. For example, other components that may be packed in a catheter or housing along with the wire devices described herein include, by way of nonlimiting example, a balloon (or other suitable device as may be useful to facilitate unpacking of multi-wire or other structures described herein), an obturator, a sensor or sensor array, intermediate filaments or ties tethering wires together, or any combinations thereof of the aforementioned elements. An obturator may, for example, be used in some techniques wherein devices herein are aligned with a target structure via on-demand puncturing of a blood vessel in-vivo as may be used in some minimally invasive surgical techniques. These techniques may, for example, be used in situations wherein routing of structure to the aortic arch through the femoral or radial artery may not be advised.

[0046] Sensors and sensor arrays may allow for detection of wire movements. Forexample, as one wire amongst a group of wires protrudes or moves in some other way. pressure or inductive coupling with a sensor or sensor array may provide an associated signal such as may be communicated to an operator. For example, pressure sensing may be particularly useful when detecting movement through a valve or other structure where a significant pressure difference may exist on opposite sides of the valve or other structure. Alternatively, as a wire moves or extends forward proximity between a sensor or sensor array and a sensing part of the wire may be changed. This may, for example, be accomplished using magnetic coupling between a sensor or sensory array and a sensing part of the wire. Tn either case, movement of the wire may manifest as a measurable signal as may be correlated with movement of the wires as a whole or individual wire among a group of wires as the case may be. This signal may, for example, be communicated to an external control unit and / or display as may be provided along with devices as described herein. Wires may generally be routed individually from a hub located at a proximal end of a catheter to a distal end of the catheter. The wires may, for example, be routed independently of each other. In other embodiments, tw o or more wires amongst multiple wires may be engaged or coupled together in some way. For example, two or more wires may be engaged or coupled together so that forward motion or protrusion of one wire automatically drives rearward motion or retraction of another wire. This may, for example, be accomplished using one or more intermediate ties or filaments linking two or more of the wires together. These features and other features are further described in the following description and Figures.

[0047] A representative embodiment of a multi-wire device 10 is shown in Fig. 1A, Fig. IB, and in Figs. 3-6. Fig. 2 show s a representative embodiment of a method 20 of using a multi -wire device. The method 20 may, for example, be used for deploying the multi-wire device 10 or for deploying related multi-wire devices 70, 120 (shown respectively in Figs. 7-8 & Fig. 25) and for routing a wire through an orifice or opening of a valve. As shown in Fig. 1 A, device 10 may include multiple wires 18 packed into ahousing body. As shown in Fig. IB, the multiple wires 18 may be configured for deployment therefrom. For example, multiple wires 18 may be packed into a housing body comprising an outer cylindrical wall of a housing 12 (sometimes referred to as a sleeve or sheath). As described above, this housing may, for example, be coupled with a catheter. For example, as shown in Fig. 25, in a related multi-wire device 120, multiple wires 18 may be packed into a secondary housing or sheath such as may be disposed in the lumen of the catheter 124. In either case, the housing 12 may be used as a delivery vehicle for the wires 18 as described above. For example, housing 12 may be introduced through a cavity 22 such as a blood vessel or other tube structure within the body. Once housing 12 is positionedat the target site, the multiple wires 18 may be deployed. For example, in some embodiments, wires 18 may be deployed by retracting the housing 12 so as to expose the distal ends of the wires 18 which emerge through the opening thereof. The wires 18 may then expand radially outwards to form a wire bouquet 16, as shown in Fig. IB, for example.

[0048] In some embodiments, a housing 12 may be shaped so as to help guide deployment of wires 18. For example, as shown in Fig. 25. a housing 12 may include a distal end including a plurality of guides 127 as may, for example, be embodied as slots, grooves, channels or openings. Wires 18 may be aligned with the guides 127. For example, individual wires 18 or a subset group of the multiple wires 18 may be seated in a given guide 127 (embodied as grooves in the illustrated embodiment). When the housing 12 is retracted the wires 18 may be guided thereby so as to help facilitate deployment in a desired manner. For example, the guides 127 may help to seat the wires at a desired spacing so as to help the wires to evenly deploy as a bouquet, for example. Fig. 26 show s a related embodiment of a distal end attachment 129 as may, for example, be seated over the end of a housing 12 (or over the related housing of a tripod or self-aligning wire array, for example). As shown therein, an attachment or coupling 129 may be fitted over the end of a housing or sheath and may provide one or more holes or openings 131. For example, as shown in Fig. 27 the distal end of a housing may include a group of three holes or openings 131 A, 131 B, 131C. The holes therein, may, for example, be used when helping to deploy a self-aligning wire array embodied as a tripod, with individual wires of the tripod being seating in one of the given openings 131 A, 13 IB, 131 C at least during a portion of deployment. Generally, a shaped distal end of a housing or attachment or fitting as the case may be retracted following deployment. In other words, once deployed the shaped structure may not be needed. However, in other embodiments, a shaped structure may remain in place for at least a portion of a medical procedure, including, for example, until a target structure is engaged or until a wire is inserted therethrough (if the target structure is a valve or opening, for example). Of course, the distal end of a housing (or attachment as the case may be), may include guides 127 or openings 131 suitable for a given arrangement of wires 18, 46. For example, if used with a self-aligning wire assembly with a different number of wires, guides 127 or openings 131 may be configured accordingly.

[0049] Following deployment, wire bouquet 16 may be maneuvered over the target site to find an opening 36 therein. For example, in some embodiments, wire bouquet 16 may be moved via manipulation of the housing 12 itself as may be controlled at the hub of a supporting catheter, for example. In certain embodiments, the wire ends are pliable and curved (e.g., “pigtail’’ shaped) allowing wire bouquet 16 to easily glide across the probed area. Once one of thewires 18 encounters opening 36. it may enter into the opening. At this point, the other wires may be pulled or slid back into housing 12 from the opposite end of the catheter. This may, for example, be accomplished manually with a user of the housing 12 individually pulling one or more of the wires 18 rearwards so as to generally leave a sole guide wire in place and threaded through the opening 36. In some embodiments, the wires 18 may be configured so that extension of one wire automatically causes the other wires to retract. This may, for example, be used to identify a particular wire having traversed into or through the opening 36.

[0050] In certain embodiments, a signal or indication that a wire has traversed an opening 36 may be provided to an operator of the device 10. This may, for example, be accomplished using a sensor 14. As the case may be, a sensor 14 may identify that at least one wire has traversed the opening 36. An operator may then identify the particular wire having traverse the opening 36. This may be accomplished, for example, by individually adjusting wires among the multiple wires 18 and receiving sensor feedback regarding whether or not the sensor signal changes. Alternatively, as further described herein, a sensor 14 may identify that a particular wire has traversed the opening 36. Generally, a sensor 14 may indicate a change in a condition resulting from a wire entering the opening. For example, the wires may have or be coupled with a sensor 14 embodied as pressure sensors and configured to detect changes in pressure resulting from a wire entering the opening. For example, wires may include one or more piezo-electric transducers. Piezo-electric transducers may, for example, be positioned at the ends of the individual wires or at a distal end and some intermediate coupling point. In another example, coupling between one or more wires and a sensor 14 may be magnetic, such as may be common in a reed switch, for example. Movement of a given wire or part of a wire towards or away from the sensor 14 may adjust a level of magnetic coupling therebetw een so that a signal indicating whether a wire has traversed the opening 36 may be provided accordingly.

[0051] In some embodiments, as shown in Figs.lA & IB, a sensor 14 may be shaped as a ring which extends about the circumference of a cylindrical wall of the housing 12. The multiple wires 18 may abut against or be disposed in suitable proximity to the sensor 14 of the housing so that wires (or each individual wire as the case may be) is operatively coupled with the sensor or sensor ring. In this context, operative coupling between a sensor 14 and multiple wires 18 (or each individual wire, as the case may be) denotes a condition wherein the wires are coupled to the sensor in such a w ay that the environment of the wire at its distal end maybe detected by the sensor. For example, a pressure surrounding a wire may be changed when a distal end of the wire passes through the opening 36. The wire may be operatively coupledto the sensor when it is engaged therewith so that this pressure change is detected by the sensor. Thus, in this context, operatively coupled may refer to a condition or state wherein the wire and sensor are close enough so that thermal conduction therebetween is facilitated. Accordingly, changes in environment of the wire (e.g., pressure) may be sensed by the sensor ring. The sensor 14 may thus provide an indication of when a wire has entered the opening via a change in pressure, or some other condition in the wire and corresponding detection by the sensor 14.

[0052] In some embodiments, a sensor 14 may be configured so that the identity of an individual wire passing through an opening may be identified. For example, sensor 14 may be embodied as a sensor array 114 (see, e g., multi-wire device 120, shown in Fig. 25). As shown therein, the sensor array 114 may include individual cells or units so that the individual cells or units of the sensor array 114 may engage with different wires. In some embodiments, the wires may each have a different radio-opaque marker that identifies each wire specifically and enables imaging to find the specific location of the wire which has entered the cavity'. As such, device 10 may be used to detect small openings. For example, housing 12 contains the bouquetshaped wires which may press against the housing walls. As the housing approaches the desired destination / cavity, the housing is pulled back allowing the wires to deploy and splay outwards as a bouquet or relatedly as a basket or other shape as the case may be.

[0053] FIGS. 7 and 8 show a related embodiment of a multi-wire device 70. The multiwire device 70 may include a guide basket 24 which may work similarly to the wire bouquet 16 (as described above). Guide basket 24 may be disposed in a housing body 82. For example, guide basket 24 may be disposed in the lumen of a housing body 82 in the form of a wire assembly in a packed state. In one example, guide basket 24 may be supported in a housing body or sleeve sized to about 4 Fr (French gauge units). This sleeve may be inserted in an outer catheter of about 6 Fr units, for example. A wire assembly may, for example, comprise wires (see, e.g., wire legs 38 and hoop structure 40, described further below ) packed in a dense state or configuration suitable for confinement in the lumen of the housing body 82. As shown in Fig. 7, the guide basket 24 may be deployed from the housing body 82 in an expanded configuration or state. In some embodiments, housing body 82 may be introduced through a cavity such as a blood vessel or other tube structure within the body and guided to a target site. Once housing body 82 is positioned at the target site, the guide basket 24 may be deployed. For example, in some embodiments, guide basket 24 may be deployed by pulling back on the housing body 82 so as to expose the guide basket 24 which emerges through the opening of the catheter. In some embodiments, legs 38 of a guide basket 24 may be oriented or positioning using a shapeddistal end of housing body 82. For example, as similarly shown in Figs. 26 & 27, a guide or opening may be included or coupled with the housing body 82. Generally, as shown in Fig. 7, in a deployed state, the guide basket 24 extends from and around the perimeter of the housing body opening.

[0054] Guide basket 24 may be configured so as to engage with a target structure, such as the aortic valve or mitral valve, for example. For example, as shown in Fig. 7, the guide basket 24 includes legs 38 which extend generally outwards from the housing's opening, and a hoop structure 40 to which the ends of the legs are connected opposite the opening of the housing. The hoop structure 40 may be sized in relation to the cross sectional area of the valve of which it is configured for engagement. In one example, the hoop structure 40 may define an area Ai (see Fig. 7) that may be about the same size or slightly larger than the cross sectional area of a valve or channel positioned adjacent the valve with which it is configured to engage so that it may, for example, generally seat about the valve when engaged therewith. That is, for example, guide basket 24 may generally be configured to engage with and come in contact with a valve or with the surrounding anatomy. Engagement with the valve may likewise help to align the distal end 86 of the housing body 82 and / or a wire array 84 extending therefrom in position with the valve’s orifice. For example, engagement of the guide basket 24 with the valve may help to push the wire array 84 in a desired way. For example, the wire array 84 may be configured to generally extend from the distal end 86 of the housing body 82 so that it generally extends through an interior portion 85 of the guide basket 24. Thus, when the guide basket 24 is engaged with a target structure (e.g., with the hoop structure 40 encircling a valve) the wire array 84 may likewise be positioned for engagement therewith.

[0055] In some embodiments, a wire array 84 may be coupled to a sensor 14, which may comprise a sensor array. The sensor 14 may. for example, be generally disposed along at least one wall of the housing body 82 as similarly described herein with respect to multi-wire devices 10, 120, for example. Generally, in some embodiments, guide basket 24 may be substantially open so as to permit fluid flow therethrough. Thus, for example, fluid pressure as may be provided by a pumping heart may not disrupt the positioning of the guide basket 24.

[0056] In some embodiments, guide basket 24 may direct and center housing body 82 and wire array 84 through a tubular or other structure 26 leading to a target structure. For example, legs 38 of the guide basket 24 may extend generally downw ards and outwards from the catheter opening. Hoop structure 40 is connected opposite the catheter opening, wherein the size of the hoop structure may correspond to the cross section area of the structure 26 with which it is intended to engage. As such, the guide basket 24 may be used for guiding thehousing body (or catheter as the case may be) directly through the center of a tubular structure 26 and thus for engagement with the valve. It is noted that the drawings in FIGS. 7 and 8 depict the wire legs 38 in linear arrangement for simplicity; however, the wires 38 may fan out over the full circular cross section in all directions. Relatedly, of course, some other number of legs 38 could be used in some embodiments. Generally, wires 38 may fan out over multiple directions yet still define a relatively open structure as may be configured to allow fluid to pass therethrough without forcing the guide basket 24 out of an engaged position with a valve, for example.

[0057] Fig. 2 shows a representative embodiment of a method 20 for deploying a multiwire device. The method 20 may, for example, be used for deploying the multi-wire device 10 (or other devices described herein, including, for example, the multi-wire devices 70, 120) and moving one of the multiple wires 18 through an orifice or opening of a valve. Generally, as shown at step 150, multi-wire device 10 (or other suitable device described herein) may be provided in a housing body or catheter. For example, in multi-wire device 10, multiple wires 18 may be packaged in the housing 12 and maintained therein in a packed or dense state prior to deployment. Alternatively, as shown for multi-wire device 70. wires forming a guide basket 24 and wire array 84 may be packaged in a housing and maintained therein prior to deployment. Generally, components of a multi-wire device 10, 70, 120 may be introduced into the body through an opening or vessel. For example, multiple wires 18 may be introduced using housing 12 which may be routed to the aortic arch through either of the femoral artery or the radial artery, for example. During routing, the multiple wires 18 may be maintained in a packed state within the housing 12. The catheter may be moved in position and aligned adjacent to the aortic valve. Visualization devices or imaging techniques such as x-ray fluoroscopy, or ultrasound may sometimes be used to assist the clinician in positioning the housing 12 (or other catheters descnbed herein) as desired in position adjacent the aortic valve.

[0058] As shown at step 152, multiple wires may be deployed. For example, with the catheter or other housing in place adjacent or near to a desired target structure wires may be deployed. For example, referring to the multi-wire device 10 and Fig. IB, multiple wires 18 may be deployed in the form of the bouquet 16. Alternatively, as shown in Fig. 7. guide basket 24 and an associated wire array 84 may be deployed. Once deployed, wires 18, 24, 84 may be moved (as shown at step 154) so as to attempt to find an opening 36. For example, as shown at step 156, wires 18 may be moved until at least one of the wires traverses an opening. For example, as a guide wire traverses the opening a signal indicating a change in environment for the guide wire may be received. As shown at step 158, the wires may then be manipulated sothat a desire arrangement of guide wires is in place. For example, an operator may manually retract all other guide wires so that only a single guide wire is in place. In some embodiments, the wires may be radio opaque as may be used to help visualize a guide wire. With the guide wire in place, one or more devices may then be moved through the opening or other useful actions may be taken. For example, a housing 12 (or other catheter described herein) may be moved through the opening.

[0059] In some embodiments as depicted in FIGS. 9 and 10, a multi-wire array 30 bundled within a catheter or housing 28 may be used to image the shape of a surface 34 within the body (e.g., walls of a cavity, such as the left or right atrium). The catheter or housing 28 may, for example, be moved through an opening (e.g., the orifice of a valve) as described above. This may, for example, allow for imaging of the shape of a surface 34 without requiring the injection of contrast or with decreased use of contrast as the case may be. In this embodiment, the individual wires 32 may be straight, rather than curved at the ends (in contrast to wires 18). In some embodiments, wires 32 may also be radio-opaque. The wires or certain units or bundles of wires may be sized to achieve a desired level of resolution as desired for imaging. Relatedly, in some embodiments, the wires 32 may be smaller in diameter than wires 18 (e.g., in the order of a sub millimeter), and may also be part of the housing wall. As catheter or housing 28 is steered along surface 34, the wires 32 in wire array 30 are each displaced based on the contours of the surface. As such, multi-wire array 30 may be used to determine the anatomy of a cavity using small wires that are radiopaque to image the walls and openings of that structure. In one example, multi-wire array 30 may be used to image or characterize walls of the atrial septum as may, for example, be used for finding a position suitable for crossing the septum wall.

[0060] Another representative embodiment of a multi-wire device 42 is shown in Fig. 11. The multi-wire device 42 may, for example, be used for finding a target structure such as an opening, hole, or valve in the body. For example, a representative embodiment of a method 60 (see Fig. 12) for finding a target structure using multi -wire device 42 is described herein. In an illustrated embodiment (see Figs. 13-19, for example) of the method 60, the multi-wire device 42 is used to find and insert a guide wire through the aortic valve. As further described herein (see Fig. 20. for example) this may, for example, be used in a method for deploying a replacement valve for the aortic valve. However, in other embodiments, multi-wire device 42 may be used differently or to engage with some other target structure.

[0061] As shown in the drawings, the multi- wire device 42 may include a self-aligning wire assembly 46. The multi-wire device 42 may also include a multiwire hole finder 44. The multiwire hole finder 44 may be configured for positioning through the self-aligning wireassembly 46 when the assembly is in a deployed position. For example, as shown in Fig. 11, the self-aligning wire assembly 46 generally bounds or encircles the multiwire hole finder 44 in its deployed position. Multiwire hold finder 44 may be positioned or guided by sliding through the self-aligned wire assembly. Thus, positioning and / or alignment of self-aligning wire assembly 46 may be used to assist corresponding positioning and / or alignment of multiwire finder 44. For example, as self-aligning assembly 46 engages with the aortic valve or nearby anatomy of the aorta, it may naturally position the multi hole finder 44 in a position adjacent the valve and centered on the valve’s orifice.

[0062] In some embodiments, multiwire hole finder 44 may comprise multiwires 48 supported in a housing, such as a catheter or sheath 50. Self-aligning wire assembly 46 may, for example, include wires 52, 54, 56 configured for deployment so as to generally engage with an opening or other target structure of interest. For example, when deployed anterior to the aortic valve, wire assembly 46 may generally engage with the patient’s anatomy so as to generally encircle the aortic valve. Accordingly, in this example, structures passed through the self-aligning wire assembly 46 (e.g.. multiwire hole finder 44) may also be aligned in a desirable ay with respect to the aortic valve. Engagement with the patient’s anatomy may work to push the hole finder 44 and / or wires therefrom in a desired way (e.g., self-centered) on a valve. Of course, in other examples, self-aligning assembly 46 may be deployed in other regions of the body or in other contexts so as to self-align about some other structure.

[0063] As shown in Fig. 11. self-aligning wire assembly 46 may comprise a group of three wires 52, 54, 56 so that it may be deployed as a tripod support. Accordingly, the wire assembly 46 may sometimes be referred to as a self-aligning tripod or more conveniently simply as tripod 46. However, in some embodiments, a different number of wires 52, 54, 56 may be used. For example, in some embodiments, three or more wires 52, 54, 56 may form the wire assembly 46. As also shown in Fig. 1 1, multi-wire device 42 may further be enclosed in a flexible housing as may be embodied, for example, as a catheter or sheath 58. Accordingly, the multi-wire finder 44 and its associated housing or sheath 50 may be enclosed within the catheter or sheath 58. In one example, outer catheter or sheath 58 may be sized to about 5 Fr units (French gauge units) to about 11 Fr units. The inner sheath 50 may be sized to fit inside of the outer catheter or sheath 58 (e.g., about 4 Fr units to about 6 Fr units). The catheter or sheath 58 may generally enclose and support the self-aligning assembly 46 so that pulling the catheter or sheath 58 backwards may be used to deploy the self-aligning assembly 46. Other components which may be part of some embodiments of multi-wire device 42 or provided therewith (e.g., in a kit configured for using the multi-wire device 42 in some way) are alsodescribed in relation to associated methods 60 & 90 (see Figs. 12 & 20). In that vein, the methods 60, 90 provide illustrative examples of methods which may, in some embodiments, use the multi-wire device 42. The associated description may be provided herein to conveniently describe certain aspects of the device 42 and / or to provide a nonlimiting description of related components sometimes used therewith.

[0064] As shown in Fig. 12, in the representative method 60, multi-wire device 42 may be used to find or locate a target structure such as the aortic valve, for example. As shown therein at step 62, self-aligning assembly 46 may then be positioned in relation to the target structure. At step 64, the self-aligning assembly 46 may be deployed and if required moved for engagement with a target structure. For example, self-aligning assembly 46 may be deployed and / or moved so as to engage with the target structure or to engage with nearby structure (e.g., anatomical structure near to an opening or valve of interest such as the walls of the aorta). Of course, elements of the assembly 46 (e.g., wires 52, 54, 56) may be configured (e.g., sized and shaped) as appropriate for engagement with a desired structure or part of a structure. In some embodiments, the act of deployment itself may encourage positioning of the self-aligning assembly 46 in a desired way. For example, the self-aligning assembly 46 may generally orient so as to position an opening defined by the assembly 46 centered with the structure of interest. In that vein, it may be convenient to describe the self-aligning assembly 46 as a self-centering apparatus. However, it should be understood that this may not always be the case. For example, in some embodiments, a self-aligning assembly 46 may also be configured to orient in some other way in relation to the structure of interest including, for example, at a desired alignment with the structure of interest or at a position purposefully offset from the center of a structure of interest. Still in other examples, an offset distance from a structure of interest (see, e.g., the distance D2 as shown in Fig. 15) may be set using a selfaligning assembly 46. At step 66, the multiwire hole finder 44 may be adjusted or moved to a desired position. In step 68, individual wires or certain collections of wires of the multiwire hole finder may be positioned in relation to the target structure.

[0065] It should be understood that the multi-wire device 42 may be configured for executing the aforementioned steps 62, 64, 66, 68 of the method 60. However, it is also the case that intermediate steps and resultant structures provided when executing those intermediate steps may be useful in some applications including those that may not require execution of each of the above steps or steps in the explicit order identified above. For example, deployment of the self-aligning assembly 46 may provide a structure that is positioned or aligned in a desirable way to a structure of interest. In some examples herein, amulti wire hole finder 44 may take advantage of this positioning so that it may, for example, be generally centered with the aortic valve 74. However, other components could also be aligned with a deployed self-centering assembly 46. For example, a bouquet 16 or wire array 84 as shown respectively, in Fig. IB and Fig. 7 may be paired with self-aligning assembly 46 and aligned w ith the aortic valve 74 so that a combination of features in the different embodiments described herein may be used. In that vein, in some embodiments, a multi-wire device 42 may not require multiwire hole finder 44. Along the same vein, wire basket 24 (as shown in Fig. 7) may be used to generally seat multi-wire hold finder 44 in relation to the valve so that again, a combination of features or elements in different embodiments herein may be used together.

[0066] As described above, step 62 of the representative method 60, self-aligning assembly 46 may be positioned in relation to a target structure. For example, as shown in Fig. 13, a guide wire 72 may generally be disposed at a position adjacent to the aortic valve 74. In the illustrated example, guide wire 72 is disposed adjacent the aortic valve so that a distal end 76 of the guide wire is generally disposed at a position defined by the plane AL Plane Ai is offset from the plane A2 which is the plane in which the face of the aortic valve is largely positioned. Generally, any suitable means may be used for positioning the guide wire 72 or distal end 76 thereof at a desired position relative to a target structure. For example, guide wire 72 may be routed to the aortic arch through the femoral or radial arleiy or using some other technique for accessing the aortic arch. Likewise, with the guide wire 72 in place, catheter 58 may be routed to the aortic arch. X-ray fluoroscopy or another suitable imaging technique may sometimes be used to set at least the initial position of the guide wire 72. Guide wire 72 may generally be selected as best for a given purpose as would be understood by one skilled in the art. For example, in the illustrated embodiment, the guide wire 72 may comprise a 0.035 inch J-tipped guide wire. In Fig. 13. the drawing is shown in perspective view so that an opening 78 of the aortic valve 74 is also shown. With guide wire 72 in place, self-aligning wire assembly 46 may then be inserted over the guide wire 72. For example, as shown in Fig. 14, selfcentering wire assembly 46 may be inserted over the guide wire 72 so that it is generally positioned adjacent to the aortic valve 74.

[0067] With the self-aligning assembly 46 now positioned in relation to the aortic valve, the self-aligning array may be deployed (step 64 in representative method 60 shown in Fig. 12). If necessary, the self-aligning assembly 46 may be moved or adjusted as may be needed to engage with a target structure. For example, in some embodiments, the guide wire 72 may be extracted and the self-aligning array (shown in Fig. 15 as tripod 46) may then be deployed by pulling back on the catheter or sheath 58. In one example, the sheath 58 generally.constrains the wires 50, 52, 54 so that when it is in place the wires 50, 52, 54 cannot splay outwards. With the sheath 58 removed or pulled back, the wires 50, 52, 54 may revert to a prestressed state, including, for example, a configuration wherein the wire 50, 52, 54 splay outwards as illustrated in Fig. 15. As shown in Fig. 15, the wires 50, 52, 54 may, for example, extend from the opening 104 of the sheath 58 so as to form a base or support sized so as to generally correspond to the cross section area of the valve 74. This may. for example, be useful to encourage engagement with the aortic valve. For example, the self-aligning assembly 46 may be deployed and moved if necessary so that the wires 50, 52, 54 become seated around the valve 74.

[0068] In one example, wires 52, 54, 56 may comprise ni tinol wires which as understood in the art may be formed in any of various shapes and sizes as desired for a particular application. In the illustrated embodiment shown in Fig. 15, tripod 46 is deployed so that the wires 52, 54, 56 may engage with and set against the face of the aortic valve 74. Generally, the wires 52, 54, 56 may be configured to deploy in a desired way, including, for example, at the respective comers of an equilateral triangle. Thus, for example, the respective wires may form “legs” of a supporting structure that generally seats about the aortic valve 74. Of course, other combinations of wires may be used to provide related supporting structures. Generally, variables used in tailoring a support structure for providing desired engagement with a structure of interest may include, by way of nonlimiting example, a number of wires, symmetry or asymmetry of the wires, length of wires and angle of deployment.

[0069] With the self-aligning assembly 46 now engaged with the aortic valve, the multi-wire hole finder 44 may be moved through the tripod 46 in a desired position such as anterior of the heart valve (step 66 in representative method 60 shown in Fig. 12). For example, as shown in Fig. 16, the multi -wire hole finder 44 may be positioned adj acent to but offset from the face of the aortic valve 74. In the illustrated embodiment, the tripod 46 is configured to generally center the hole finder 44 and to stabilize the hole finder 44 in place about center but offset anterior to the valve 74. For clarity in Fig. 16 so as to avoid obscuring view of the hole finder 44 one of the three wires 52, 54, 56 has been omitted from view.

[0070] With the multi-wire hole finder 44 now positioned about centered and anterior of the aortic valve 74, as shown at step 68, individual wires 80 of the hole finder may be moved or positioned with respect to the target structure. For example, as shown in Fig. 17, individual wires 80 may be moved until at least one of the wires passes through the heart valve (not shown for clarity in Fig. 17, but generally disposed at the position of the plane A2). In some embodiments, each individual wire 80 may have a marker band and particular sensoridentification. For example, as similarly described for the multi -wire device 10, wires may be identified via a sensor 14 that may indicate a change in condition resulting from said wire entering the opening. In one embodiment, the wires may have or be coupled with temperature and / or pressure sensors which provide an indication when a wire has entered the opening via a change in temperature or pressure in the wire. In another embodiment, the wires may each have different radio-opaque markers that identify each wire specifically and enable imaging to find the specific location of the wire which has entered the ventricle (or other cavity structure associated with a valve or other target structure, for example).

[0071] Thus, as generally shown at Fig. 17, method 60 may be used advantageously to facilitate ease of positioning of a wire through the aortic valve 74 (or through some other valve). Notably, this may be done quickly and minimizing risk of damage or dissection of the target structure (e.g., the aortic valve) or of other adjacent or nearby anatomy. Generally, devices may then be routed through the wire 80 for various applications. For example, wire 80 may act as a guide for inserting a catheter 28 as shown in Fig. 10 so that one or more walls of the ventricle may be characterized. Alternatively, a catheter may be routed to the ventricle for delivery of a therapeutic or diagnostic agent. In some embodiments, self-aligning wire assembly^ 46 may be positioned into the ventricle. For example, self-aligning wire assembly 46 may be part of a suitably shaped catheter (e.g., one with an appropriately shaped tip so as to minimize risk of damage to the patient's anatomy). Generally, this may be done with or without prior removal of other structure described herein. For example, in some embodiments, one or more components of the original guide wire 72, self-aligning assembly 46, and / or multi -wire hole finder 44 may be retracted fully or in part prior to additional actions being taken. For example, as shown in Fig. 18, other guide wires amongst the multiwires 48 may be retracted. Likewise, as shown in Fig. 19. wires 52, 54, 56 of the self-aligning assembly 46 may be retracted. For example, in the illustrated embodiment shown in Fig. 19, the self-aligning assembly' 46 is partially retracted into the associated sheath 58. Alternatively, the self-aligning assembly 46 may be fully retracted and removed from a patient’s body before additional actions are taken.

[0072] For example, a representative embodiment of a method 90 is shown in Fig. 20. Method 90 may, for example, be used to deliver a replacement for the aortic valve. Generally, method 90 may be executed following insertion of a wire 80 through the aortic valve 74 as described above. In this illustrated example, the housing or sheath 58 of multi- wire device 42 may be embodied as a catheter 58. At step 92. catheter 58 may be advanced through the aortic valve 74. For example, as shown in Fig. 21, catheter 58 may be advanced along the wire 80.At step 94, multi-wire finder 44 may be extracted from the self-aligning assembly 46 (illustrated as tripod 46 in the related illustrated drawing of Fig. 22). Notably, in this step the guide wire 80 may also be removed. For example, with the catheter 58 successfully inserted through the aortic valve 74, the multi-wire finder 44 including its complete suite of multiwires 48 and successfully inserted wire 80 may be removed. At step 96, additional guide wire 102 may be inserted through the self-aligning assembly 46 or tripod as illustrated in associated Fig. 23. In step 98. the self-aligning assembly 46 or tripod 46 may be extracted. Other structures of the multi-wire device 42 (if present) may likewise be extracted so that additional guide wire 102 is left disposed in the left ventricle. This guide wire 102 may, for example, be a custom guide wire particularly configured for use with a replacement valve of the aorta. The replacement valve (not shown) may then be fed and associated steps taken to install the replacement valve.

[0073] Thus, as described above, a multi-wire device 42 may be used in methods 60, 90 for inserting a wire through a valve (e.g., the aortic valve) and using the wire as a guide in a method of valve replacement. Although illustrated with respect to the device 42, the methods 60. 90 may be adapted for use with a multi-wire device 70 and a guide basket 24. For example, a representative procedure of using a multi-wire device 70 may include feeding a 0.035 inch J- tipped guide wire up to a valve in the ascending aorta. A 6 Fr AL-1 guide catheter may be inserted over the guidewire. Multi-wire device 70 may be comprised of a 4 Fr sleeve compatible with the guide wire. The device 70 may be fed through the guide catheter so as to position the device adjacent the heart valve. The original 0.035 inch guide wire may be extracted. A 0.035 inch straight soft tipped guide wire may then be fed through the guide basket 24 and into the left ventricle. The guide basket 24 may then be retracted into the 4 Fr sleeve. The 6 Fr sleeve / guide basket may then be extracted. Likewise, the existing guide wire (0.035 inch straight soft tipped guide wire) may likewise be extracted. An extra length wire may then be fed into the left ventricle. The 6 Fr AL-1 and 4 Fr sleeve / guide basket may then be extracted. A 6 Fr angled pigtail catheter may then be inserted into the left ventricle. The exchange wire may then be extracted. A safari extra small wire may then be fed into the left ventricle and the 6 Fr catheter may be extracted. Finally, a TAVR device may be delivered under rapid pacing over the Safari wire. Of course, the above procedure is simply illustrative of one representative embodiment for using the device 70.

[0074] The disclosed subject matter provides a device for finding openings, and detecting the shape of internal organs, walls, etc., which shortens time of radiation, lowers the amount of contrast needed and procedure time, reduces failure rate and increases precision. Insome embodiments, the multiple wires may be held together by a sheath and introduced into the catheter. In some embodiments, the catheter may have an angle for enabling the wires to be moved. Additionally, the wires may be radio-opaque and have unique identifiers. In certain embodiments, the wires are small pliable wires. The wires cover a greater surface area in comparison to a single wire, and therefore enable identifying the shape of a cavity7and / or any openings therein. The multiple wires increase the chances of finding an opening and lower the need for more intravenous contrast. In embodiments, the wires may include sensor(s) at their ends that will alert a change, thus identifying the wire that entered into the opening. The disclosed device further allows for imaging the shape and curves of a cavity such as a heart chamber or w all using multiple w ires that can better define the internal shape of the organ. The device may thus be used for determining the anatomy of a cavity or a heart chamber for procedures requiring puncturing in the middle of the organ.

[0075] The disclosed device may have various configurations in alternate embodiments. For example, the disclosed device may use any number / densify of wires, w hich may be of different shapes and dimensions, depending on the application and needs / preferences of the patient and practitioner. Additionally, the radiopaque identifiers on the wires can be reconfigured, and / or different types of sensors (which may be used to identify7changes on pH, pressure, flow, temperature etc.), may be used in alternate embodiments. In some embodiments, the delivery catheter may be reconfigured based on the specific application. For example, the catheter may include various shapes and curves as well as malleability7that enables it to better maneuver inside a cavity or space. In some further embodiments, the wires may have added ability to provide electrical stimulation, such as in a transvenous pacemaker.

[0076] It shall be appreciated that the disclosed device may be used in other applications outside of medicine, where finding an opening in a structure is necessary. It shall be appreciated that the components of multi-wire catheter device 10 may comprise any alternative known materials in the field and be of any size and / or dimensions. It shall be appreciated that the components of multi -wire catheter device 10 may be manufactured and assembled using any known techniques in the field.

[0077] It shall be understood that the orientation or positional relationship indicated by terms such as "upper", "lower", "front", "rear", "left", "right", "top", "bottom", "inside", "outside" is based on the orientation or positional relationship shown in the accompanying drawings, which is only for convenience and simplification of describing the disclosed subject matter, rather than indicating or implying that the indicated device or element must have a specific orientation or are constructed and operated in a specific orientation, and thereforeshould not be construed as a limitation of the present invention.

[0078] As used herein, the articles “a” and "an" are intended to include one or more items, and may be used interchangeably with ‘'one or more.” Where only one item is intended, the term “one” or similar language is used. Also, as used herein, the terms “has”, “have”, “having”, ‘With” or the like are intended to be open-ended terms. Further, the phrase “based on” is intended to mean “based, at least in part, on” unless explicitly stated otherwise.

[0079] The constituent elements of the disclosed device and device listed herein are intended to be exemplary only, and it is not intended that this list be used to limit the device of the present application to just these elements. Persons having ordinary skill in the art relevant to the present disclosure may understand there to be equivalent elements that may be substituted within the present disclosure without changing the essential function or operation of the device. Terms such as ‘approximate,’ ‘approximately,’ ‘about,’ etc., as used herein indicate a deviation of within + / -10%. Relationships between the various elements of the disclosed device as described herein are presented as illustrative examples only, and not intended to limit the scope or nature of the relationships between the various elements. Persons of ordinary skill in the art may appreciate that numerous design configurations may be possible to enjoy the functional benefits of the inventive devices. Thus, given the wide variety of configurations and arrangements of embodiments of the present invention the scope of the invention is reflected by the breadth of the claims below- rather than narrowed by the embodiments described above.

Claims

WHAT IS CLAIMED IS:

1. A device comprising: a housing body enclosing an array of multiple wires, the wires being packed within the housing body in a packed configuration and configured so as to deploy from the distal end of the catheter to provide a wire bouquet in an expanded state; and a sensor operatively coupled to the array of multiple wires.

2. The device of claim 1, the wire bouquet being configured for movement over a target structure.

3. The device of claim 2, the multiple wires being prestressed so as to adopt a pigtail shape when deployed in said wire bouquet.

4. The device of claim 1, said sensor being disposed about at least one wall of the housing body.

5. The device of claim 4 wherein the array of multiple wires is disposed so as to abut against the at least one wall of the housing body.

6. The device of claim 4, the sensor being a sensor array comprised of a plurality7of individual cells each of said individual cells being associated with a particular wire included amongst said multiple wires.

7. The device of claim 1, each of the wires amongst the wire array being radio opaque.

8. The device of claim 1 wherein the array of multiple wires is packed within an outer cylindrical wall of the housing body embodied as a catheter, the outer cylindrical wall of the catheter supporting the array of multiple wires in said packed configuration.

9. The device of claim 1 wherein the array of multiple wires is packed within a lumen of a catheter, an interior wall or housing disposed in the catheter supporting the array of multiple wires in said packed configuration.

10. The device of claim 1, each of the wires amongst the wire array being made of ni tinol.

11. A device comprising: a housing body containing a wire assembly packed within the housing body in a packed configuration and configured so as to deploy from the distal end of the housing body to provide a wire basket including an interior in an expanded state; and a wire array, the wire array being configured for extension through said interior of the wire basket.

12. The device of claim 11, the wire basket comprising a plurality of legs and a hoop, the hoop being secured to the plurality of legs.

13. The device of claim 12, the hoop being held by the plurality of legs substantially in a plane when the wire basket is deployed in said expanded state, the hoop sized for engagement with a cross sectional area within said plane.

14. The device of claim 13 w herein the cross sectional area is about the size of a valve in the human body.

15. The device of claim 14 wherein the cross sectional area is sufficient so as to align the hoop against walls of a blood vessel.

16. The device of claim 14 w herein the cross sectional area is sufficient so as to align the hoop against walls of the aorta in the vicinity of the aortic valve.

17. The device of claim 11 further comprising a sensor operatively coupled to the wire array.

18. The device of claim 17, the sensor being a sensor array comprised of a plurality of individual cells each of said individual cells being associated with a particular wire included amongst said wire array.

19. The device of claim 11, each of the wires amongst the wire array being radio opaque.

20. The device of claim 11, the wire basket being shaped so as to engage about a a valve of the human body.

21. A device configured for engagement with an aortic valve of the human body, the device comprising: a housing body containing a wire assembly packed within the catheter in a packed configuration and configured so as to deploy from the distal end of the catheter to provide a wire basket including an interior in an expanded state, the wire basket comprising a plurality of legs and a hoop, the hoop being secured to the plurality of legs and sized for engagement with the aortic valve; and a wire array, the wire array being configured for extension through an interior of the wire basket.

22. The device of claim 21 further comprising a sensor operatively coupled to the wire array.

23. The device of claim 22, the sensor being a sensor array comprised of a plurality of individual cells each of said individual cells being associated with a particular wire included amongst said wire array.

24. The device of claim 21, each of the wires amongst the ware array being radio opaque.

25. A device comprising: a housing body for a wire assembly in a packed configuration, the wire assembly comprising a plurality of wires configured for deployment in an expanded state; and a multi-wire hole finder comprising: a housing; and a plurality of wires packed within the housing, individual wire among theplurality of wires being configured for extension through a space bounded by the wire assembly in its expanded state.

26. The device of claim 25 further comprising a sensor operatively coupled to the plurality of wires.

27. The device of claim 27, the sensor being a sensor array comprised of a plurality of individual cells each of said individual cells being associated with a particular wire included amongst said the plurality of wires.

28. The device of claim 27 said plurality of wires comprising three or more wires.

29. The device of claim 27 said plurality of wires comprising a tripod.

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