Patent Abstract:
A measuring device for measuring tunnel defects in tissue is disclosed. The measuring device can size the defect to aid future deployment of a tissue distension device. Exemplary tunnel defects are atrial septal defects, patent foramen ovales, left atrial appendages, mitral valve prolapse, and aortic valve defects. Methods for using the same are disclosed.

Full Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Application No. 60/866,569, filed 20 Nov. 2006, which is incorporated by reference herein in its entirety. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of the Invention 
         [0003]    The invention is related to the measuring devices and measurement of anatomical pathologies. 
         [0004]    2. Description of the Related Art 
         [0005]    The ability to accurately measure the dimensions of anatomical structures is of vital importance. In many cases, the anatomical geometry defines the treatment. A small object, small hole, or short length of anatomical pathology can go untreated because it has little to no clinical significance. Larger objects, holes, and longer length of anatomical pathology may lead to adverse clinical outcomes. 
         [0006]    Additionally, many anatomical pathologies are treated with devices, including implantable devices, that are sized to fit the pathology. Knowledge of the specific size of the pathology aids the selection of an appropriately sized treatment device. Using trial and error techniques to determine the proper size of an implantable treatment device undesirably prolongs the surgical procedure, and fitting and removing improperly sized devices often further traumatizes the already-injured anatomical site. 
         [0007]    Existing devices do not easily measure tunnel defects in soft tissue within body structures. Tunnel defects can be found in the heart (e.g., patent foramen ovale (PFO), left atrial appendage, mitral valve prolapse, aortic valve defects). Tunnel defects can be found through out the vascular system (e.g., venous valve deficiency, vascular disease, vulnerable plaque, aneurysms (e.g., neurovascular, abdominal aortic, thoracic aortic, peripheral). Tunnel defects can be found in non vascular systems (e.g., stomach with GERD, prostate, lungs). 
         [0008]    A device for measuring the width of a distended defect in tissue is disclosed. The device has a longitudinal axis. The device can have a first elongated member. The first elongated member can be configured to expand away from the longitudinal axis. The device can have a second elongated member. The first elongated member can be opposite with respect to the longitudinal axis to the second elongated member. The second elongated member can be configured to expand away from the longitudinal axis. The device can have a lumen, for example, in a catheter. The device can have a porous cover on the lumen. 
         [0009]    A method for sizing a tunnel defect. The method can include inserting a measurement tool into the tunnel defect. The method can include distending the tunnel defect into a distended configuration. The method can include measuring the tunnel defect in the distended configuration. Distending can include radially expanding the measurement tool. Measuring can include bending the first measuring wire around a front lip of the tunnel defect. Measuring can include emitting a contrast fluid in the tunnel defect. 
       BRIEF SUMMARY OF THE INVENTION 
       [0010]    Tissue distension devices can be deployed to tunnel defects in tissue. The tissue distension devices can be used to substantially close tunnel defects to treat, for example, patent foramen ovale (PFO), left atrial appendage, mitral valve prolapse, aortic valve defects. Examples of tissue distension devices include those disclosed in U.S. patent application Ser. No. 10/847,909, filed 19 May 2004; Ser. No. 11/184,069, filed 19 Jul. 2005; and Ser. No. 11/323,640, filed 3 Jan. 2006, all of which are incorporated by reference herein in their entireties. 
         [0011]    To select a properly fitting tissue distension device, a measuring tool can first be deployed to measure the size of the tunnel defect. The tunnel defect can be measured in a relaxed or distended configuration. The tunnel defect can be distended by the measuring tool before or during measurement. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0012]      FIG. 1  illustrates a variation of the measurement tool in a first configuration. 
           [0013]      FIGS. 2   a,    2   b,    3   a  and  3   b  illustrate variations of cross-section A-A of  FIG. 1 . 
           [0014]      FIGS. 4 and 5  illustrate various embodiments of cross-section B-B of  FIG. 1 . 
           [0015]      FIGS. 5 through 11  and  13  through  16  illustrate variations of the measurement tool in a second configuration. 
           [0016]      FIG. 12  is a close-up view of the a portion of the measurement tool of  FIG. 11  including the first measuring wire only, for illustrative purposes, transforming from a radially contracted to a radially expanded configuration. 
           [0017]      FIGS. 17 through 27  illustrate variations of the measuring wire. 
           [0018]      FIG. 28  illustrates a variation of cross-section C-C of  FIG. 27 . 
           [0019]      FIG. 29  illustrates a variation of cross-section D-D of  FIG. 27 . 
           [0020]      FIG. 30  illustrates a variation of a wire assembly. 
           [0021]      FIG. 31  illustrates a variation of a wire sub-assembly. 
           [0022]      FIG. 32  illustrates a variation of a wire assembly. 
           [0023]      FIG. 33  illustrates a variation of a wire sub-assembly. 
           [0024]      FIG. 34  illustrates a variation of a wire assembly. 
           [0025]      FIGS. 35-37  illustrate variations of the measurement tool. 
           [0026]      FIGS. 38   a  and  38   b  illustrate various sections of tissue having a tunnel defect. 
           [0027]      FIG. 39  illustrates the tunnel defect of  FIG. 38   a  or  38   b.    
           [0028]      FIGS. 40 through 42  illustrate a variation of a method for deploying an embodiment of the measurement tool. 
           [0029]      FIGS. 43 and 44  illustrate a variation of a method for using various embodiments of the measurement tool. 
           [0030]      FIG. 45  illustrates a variation of a method for using a variation of the measurement tool. 
           [0031]      FIGS. 46 and 47  illustrate a variation of a method for using a variation of the measurement tool. 
           [0032]      FIGS. 48 and 49  illustrate a variation of a method for using a variation of the measurement tool. 
       
    
    
     DETAILED DESCRIPTION 
       [0033]      FIG. 1  illustrates an anatomical measurement tool  2 , such as a tool for measuring the width in a relaxed and/or distended configuration of a tunnel defect  156  in tissue  154 , in a radially contracted configuration. The measurement tool  2  can have a longitudinal axis  16 . The anatomical measurement tool  2  can have a catheter  26 , a first measuring wire  100   a,  and a second measuring wire  100   b.  The measuring wires  100  can be deformable, resilient, or combinations thereof over the length of the measuring wires  100 . 
         [0034]    The catheter  26  can have a catheter porous section  20 . The catheter  26  can be entirely substantially non-porous. The catheter  26  can have a catheter non-porous section  24 . The catheter porous section  20  can partially or completely circumferentially surround the catheter  26 . The catheter porous section  20  can have holes or pores in the catheter outer wall  28 . The pores can have pore diameters from about 1 μm (0.04 mil) to about 1 mm (0.04 in.), more narrowly from about 2 μm (0.08 mil) to about 300 μm (10 mil), for example about 150 μm (6.0 mil). 
         [0035]    The first  100   a  and second measuring wires  100   b  can each have at least one wire radially constrained section  10  and at least one wire radially unconstrained section  8 . The measuring wires  100  can transition from the wire constrained sections  10  to the wire radially unconstrained sections  8  at the wire proximal sheath ports  22 . The first  100   a  and second measuring wires  100   b  between the wire proximal sheath ports  22  and the wire distal anchor  14  can be the radially unconstrained sections  8 . The measuring wires  100  can be distally fixed to the catheter  26  at a wire distal anchor  14 . The wire distal anchor  14  can be a hinged or otherwise rotatable attachment, for example, to allow the measuring wire  100  to rotate away from the longitudinal axis  16  at the wire distal anchor  14  during use. 
         [0036]    The measurement tool  2  can have a tip  12  extending from a distal end of the catheter  26 . The tip  12  can be blunt or otherwise atraumatic (e.g., made or coated with a softer material than the catheter  26 , made with a soft substantially biocompatible rubber tip  12 ). A guide lumen  4  can extend from the tip  12 . The guide lumen  4  can be configured to slidably receive a guidewire  170 . The guide lumen  4  can exit through a dimple in the tip  12 . The tip  12  need not be dimpled at the exit of the guide lumen  4 . 
         [0037]      FIG. 2   a  illustrates that the catheter  26  can have a catheter outer wall  28 . The catheter outer wall  28  can be porous, or non-porous, or partially porous and partially non-porous. The catheter  26  can have a fluid lumen  36 . The guide lumen  4  can be configured central to the cross-section of the catheter  26  or offset from the center of the cross-section, for example attached to the catheter outer wall  28 . The guide lumen can have a guide lumen wall  34 . 
         [0038]    The first measuring wire  100   a  can removably and slidably reside in or removably and slidably attach to a recessed or raised first track  32  in the catheter outer wall  28 . The second measuring wire  100   b  can removably and slidably reside in or removably and slidably attach to a recessed or raised second track  40  in the catheter outer wall  28 . 
         [0039]    To transform the measurement tool  2  from the radially contracted configuration to the radially expanded configuration, the first  100   a  and second measuring wires  100   b  in the wire radially constrained section  10  can be longitudinally translated, as shown by arrows  54  (not shown in  FIG. 2   a ), in a distal direction. The first and second wires, for example, rotatably fixed at the wire distal anchor  14  and not radially constrained between the wire proximal sheath ports  22  and the wire distal anchor  14 , can translate, as shown by arrows  52  (not shown in  FIG. 2   a ), radially outward from the longitudinal axis  16 . 
         [0040]      FIG. 2   b  illustrates that the measuring wires  100  can have a configuration substantially equivalent to the configuration of the respective track  32  or  40 . The measuring wires  100  and catheter  26  can be configured to create a substantially smooth, flush, regular configuration to the radial exterior cross-section (e.g., at A-A) of the measurement tool  2  when the wires  100  are in a contracted configuration. For example, the radially exterior cross-section (e.g., at A-A) of the measurement tool  2  can be configured substantially as a circle when the wires  100  are in a contracted configuration. 
         [0041]      FIG. 3   a  illustrates that the first  100   a  and second measuring wires  100   b  in the wire radially unconstrained section  8  can be adjacent to, and reside on or attach to, the catheter outer wall  28 . The catheter outer wall  28  can have no tracks for the measuring wires  100 . 
         [0042]      FIG. 3   b  illustrates that the measuring wires  100  can have a low-profile configuration. The low-profile configuration can have a cross-sectional configuration (e.g., at A-A) of a semi-circle, crescent, arc, oval, rectangle, or combinations thereof. The low-profile configuration can have a larger angular dimension than radial dimension, when measured with respect to the substantial center of the measurement device in the longitudinal direction. The measuring wires  100  and catheter  26  can be configured to create a substantially smooth, flush and regular exterior surface of the measurement tool  2  when the wires  100  are in a contracted configuration. 
         [0043]      FIG. 4  illustrates that the first  100   a  and second measuring wires  100   b  can be slidably attached to and/or encased by first  48  and second sheaths  50 , respectively. The interior of the sheaths can be coated with a low-friction material (e.g., polytetraflouroethylene (PTFE), such as Teflon® by E.I. du Pont de Nemours and Company, Wilmington, Del.). 
         [0044]      FIG. 5  illustrates that the first sheath  48  and/or the second sheath  50  can be inside the catheter  26  (i.e., radially interior to the catheter outer wall  28 ). 
         [0045]    The wire distal anchor  14  and wire sheaths  48  and/or  50  can be fixedly attached to the catheter  26 . The wire distal anchor  14  and wire sheaths  48  and/or  50  can be slidably attached to the catheter  26 . 
         [0046]    The catheter outer wall  28  can be porous and/or non-porous, for example at different lengths along the catheter  26 . For example, the catheter outer wall  28  in  FIGS. 3   a  and  3   b  can be porous and the catheter outer wall  28  in  FIGS. 4 and 5  can be non-porous. 
         [0047]    The catheter  26  and/or tip  12  can have a stop. The stop can be longitudinally fixed with respect to the catheter  26  and/or the tip  12 . The stop can be the tip  12 , for example if the diameter of the tip  12  is larger than the diameter of the wire distal anchor  14 . The stop can be configured to interference fit against the wire distal anchor  14  when the wire distal anchor  14  is distally translated beyond a maximum translation point with respect to the catheter  26  and/or tip  12 . 
         [0048]      FIG. 6  illustrates the measurement tool  2  in a radially expanded configuration. The first  100   a  and second measuring wires  100   b  in the wire radially unconstrained section  8  can bow, flex, or otherwise be radially distanced or translate, as shown by arrows  52 , with respect to the longitudinal axis  16  from the catheter  26 . The first  100   a  and second measuring wires  100   b  can expand in a single plane (i.e., be coplanar). 
         [0049]    The measuring wires  100  can be longitudinally translated, as shown by arrows  54 , in the wire radially constrained sections  10 . The first  100   a  and second measuring wires  100   b  in the wire radially unconstrained sections  8  can be radially expanded or otherwise translated, as shown by arrows, away from the catheter  26  (e.g., longitudinal axis  16 ) into a radially expanded configuration, for example by distally translating the measuring wires  100  in the wire radially constrained sections  10 . The first  100   a  and second measuring wires  100   b  in the wire radially unconstrained sections  8  can be radially contracted or otherwise translated toward the catheter  26  (e.g., longitudinal axis  16 ) into a radially contracted configuration, for example by proximally translating the measuring wires  100  in the wire radially constrained section  10 . 
         [0050]      FIG. 7  illustrates that the catheter porous section  20  can have a porous section length  56 . The longitudinal distance between the wire distal anchor  14  and the wire proximal sheath ports  22  (i.e., the wire radially unconstrained section  8 ) can be an unconstrained wire longitudinal length  58 . The unconstrained wire longitudinal length  58  can be less than, substantially equal to (as shown in  FIGS. 1 and 6 ), or greater than (as shown in  FIG. 7 ) the catheter non-porous section  24 . 
         [0051]      FIG. 8  illustrates that the first and second wires can have substantially discrete angles when the wires are in the radially expanded configurations. Each wire  100  can have a wire first hinge point  60  and a wire second hinge point  66 . The wire hinge points  60  and/or  66  can be biased (e.g., before the measurement tool  2  is configured in the first configuration) to bend when the tension on the measuring wire  100  is decreased. The wire hinge points  60  and/or  66  can have hinges  106 , bends, seams, links, other articulations, or combinations thereof. 
         [0052]    The wire first hinge point  60  can have a wire first hinge angle  62   a.  The wire second hinge point  86  can have a wire second hinge angle  62   b.  In a radially expanded configuration, the wire hinge first and second angles  62   a  and  62   b  can be from about 10° to about 170°, more narrowly from about 30° to about 150°, yet more narrowly from about 45° to about 135°, for example about 125°. The wire hinge angle  62  when the measurement tool  2  is in a radially expanded configuration can be equivalent to the hinge angle  62 , described infra, when the measurement tool  2  is in a radially contracted configuration. 
         [0053]      FIG. 9  illustrates that the measurement tool  2  can have about  12  measuring wires  100 . The measuring wires  100  can be radially expandable in a configuration where the first measuring wire  100   a  deploys substantially longitudinally adjacent to a third measuring wire  100   c.  The measuring wires  100  can be radially expandable in a configuration where the second measuring wire  100   b  deploys substantially longitudinally adjacent to a fourth measuring wire  100   d.    
         [0054]    The measuring wires  100  can each have a unique or paired longitudinal position for their wire proximal sheath ports  22  and wire distal anchors  14 . For example, the first  100   a  and second measuring wires  100   b  can exit from wire first proximal sheath ports  22   a  (not shown on  FIG. 9 ) and can be fixed at wire first distal anchors  14   a  (not shown on  FIG. 9 ). The third  100   c  and fourth measuring wires  100   d  can exit from wire second proximal sheath ports  22   b  (not shown on  FIG. 9 ) and can be fixed at wire second distal anchors  14   b  (not shown on  FIG. 9 ). The wire first distal anchors  14   a  can be distal to the wire second distal anchors  14   b.  The wire first proximal sheath ports  22   a  can be at a substantially equivalent longitudinal position to the wire second distal anchors  14   b.  The wire second distal anchors  14   b  can be distal to the wire second proximal sheath ports  22   b.  This longitudinal spacing of the wire distal anchors  14  and wire proximal sheath ports  22  can be used for all of the measuring wires  100 . 
         [0055]    The measuring wires  100  on each side of the catheter  26  (e.g., the first, third, fifth, seventh, ninth and eleventh measuring wires or the second, fourth, sixth, eighth, tenth and twelfth measuring wires) can pass through the same or different sheaths. 
         [0056]      FIG. 10  illustrates that the measuring wires  100  can have distal ends that are not attached to the catheter  26  when the measuring wires  100  are in radially expanded configurations. Any or all measuring wire  100  can have a terminal end  80 . When the measurement-tool  2  is in a radially expanded configuration, the terminal ends  80  can be unattached to the catheter  26 . When the measurement tool  2  is in a radially expanded configuration, the measuring wires  100  can have a medial turn  82 , bend, hinge  106 , or otherwise angle medially between the terminal ends  80  and the wire proximal ports. A length of the measuring wires  100  can be biased to turn or bend medially when that length of the measuring wire  100  is in a relaxed configuration. The measurement tool  2  can have about eight measuring wires  100 . 
         [0057]      FIG. 11  illustrates that the measuring wires  100  can form a substantially circular or oval loop when the measuring wire  100  is in the radially expanded configuration. The measurement tool  2  can have six measuring wires  100 . Each measuring wire  100  can have a separate proximal sheath port  22  (e.g., first, second, third, fourth, fifth and sixth proximal sheath ports  22   a,    22   b,    22   c,    22   d,    22   e,  and  22   f ), and wire distal anchors  14  (e.g., wire first, second, third, fourth, fifth and sixth distal anchors  14   a,    14   b,    14   c,    14   d,    14   e  and  14   f ) 
         [0058]      FIG. 12  illustrates that the loop of wire radially unconstrained section  8  can expand when the measuring wires  100  transform from the radially contracted configuration to the radially expanded configuration. The measuring wires  100  can be longitudinally translated, as shown by arrow  54 , in the wire radially constrained sections  10 . Along the length of the measuring wires  100  near the wire proximal port, the measuring wires  100  can translate along the longitudinal wire-axis, as shown by arrow  84 . The measuring wires  100  in the wire radially unconstrained sections  8  can be radially expanded or otherwise translated, as shown by arrow  52 , away from the catheter  26  (e.g., longitudinal axis  16 ) into a radially expanded configuration, for example by distally translating the measuring wires  100  in the wire radially constrained sections  10 . The measuring wires  100  in the wire radially unconstrained sections  8  can be radially contracted or otherwise translated toward the catheter  26  (e.g., longitudinal axis  16 ) into a radially contracted configuration, for example by proximally translating the measuring wires  100  in the wire radially constrained section  10 . 
         [0059]      FIG. 13  illustrates that the measuring wires  100  can exit from the respective wire sheaths at the respective wire proximal ports. The measuring wires  100  can all exit the wire proximal ports on the same side of the catheter  26 , or immediately turn to the same side of the catheter  26  after exiting the proximal wire ports. When the measurement tool  2  is in a radially expanded configuration, the measuring wires  100  can have a proximal turn, bend, hinge  106 , or otherwise angle proximally after exiting the proximal wire port. When the measurement tool  2  is in a radially expanded configuration, the measuring wires  100  can have a medial turn  82 , bend, hinge, or otherwise angle toward the longitudinal axis  16 , for example, between the proximal bend  90  and the terminal end  80 . Any length of the measuring wires  100  can be biased to turn or bend when that length of the measuring wire  100  is in a relaxed configuration.  FIG. 14  illustrates that the measuring wire  100  can have a proximal turn, bend, hinge  106 , or otherwise angle proximally. 
         [0060]      FIG. 15  illustrates that the catheter  26  can be removably or fixedly attached to a coupler  96 . The coupler  96  can be removably or fixedly attached to a handle  98 . The coupler  96  can be made from any material disclosed herein including rubber, elastic, or combinations thereof. The coupler  96  can have a substantially cylindrical configuration. The coupler  96  can have threads. The coupler  96  can have slots. The couple can have a joint and/or hinge  106 . 
         [0061]    The coupler  96  can be flexible. The coupler  96  can substantially bend, for example, permitting the longitudinal axis  16  of the handle  98  to be a substantially non-zero angle (e.g., from about 0° to about 90°) with respect to the longitudinal axis  16  of the catheter  26 . The coupler  96  can permit substantially resistance free rotation between the longitudinal axis  16  of the catheter  26  and the longitudinal axis  16  of the handle  98 . 
         [0062]      FIG. 16  illustrates that the coupler  96  can be removably or fixedly attached to the catheter  26  on the proximal and distal end of the coupler  96 . The coupler  96  can have and/or be proximally adjacent to the wire proximal sheath ports  22 . 
         [0063]    The measuring wire  100  can have a low and/or high friction surface. The measuring wire  100  can have a higher friction surface on the side of the measuring wire  100  radially exterior to the catheter  26  and a lower friction surface on the side of the measuring wire  100  radially interior to the catheter  26 . The measuring wire  100  can have a surface having a substantially uniform friction around substantially the entire measuring wire  100 . 
         [0064]    The surface of the measuring wire  100  can be textured, for example knurled, pebbled, ridged, Toped, or combinations thereof. The surface of the measuring wire  100  can be textured on the side of the measuring wire  100  radially exterior to the catheter  26  and not substantially textured on the side of the measuring wire  100  radially interior to the catheter  26 . The surface of the measuring wire  100  can be substantially uniformly textured around substantially the entire measuring wire  100 . 
         [0065]    The surface of the measuring wire  100  can be encrusted with a granulized material, for example diamond, sand, a polymer, the material from which the measuring wire  100  is made, any other material described herein, or combinations thereof. The surface of the measuring wire  100  can be encrusted on the side of the measuring wire  100  radially exterior to the catheter  26  and not substantially encrusted on the side of the measuring wire  100  radially interior to the catheter  26 . The surface of the measuring wire  100  can be substantially uniformly encrusted around substantially the entire measuring wire  100 . 
         [0066]      FIG. 17  illustrates that the measuring wire  100  can have a wire body  104  and one or more markers  102 . The wire body  104  can have no markers  102 . The markers  102  can be echogenic, radiopaque, magnetic, or configured to be otherwise visible by an imaging technique known to one having ordinary skill in the art. The markers  102  can be made from any material disclosed herein including platinum (e.g., pure or as powder mixed in glue). 
         [0067]    The markers  102  can be uniformly and/or non-uniformly distributed along the length of the wire body  104 . The markers  102  can be uniformly and/or non-uniformly distributed along the radius of the wire body  104 . The markers  102  can be separate and discrete from the wire body  104 . The markers  102  can be attached to the wire body  104 . The markers  102  can be incorporated inside the wire body  104 . The marker  102  can have configuration symmetrical about one, two, three, or more axes. The marker  102  can have an omnidirectional configuration. The marker  102  can have a configuration substantially spherical, ovoid, cubic, pyramidal, circular, oval, square, rectangular, triangular, or combinations thereof. The marker&#39;s  102  radius can be smaller than or substantially equal to the wire body&#39;s  104  radius at the location of the marker  102 .  FIG. 18  illustrates that the marker&#39;s  102  radius can be greater than the wire body&#39;s  104  radius at the location of the marker  102 . 
         [0068]      FIG. 19  illustrates that the marker  102  can have a unidirectional configuration. The marker  102  can be configured in the shape of an arrow. All or subsets of the markers  102  on a wire body  104  can be aligned, for example all of the unidirectionally configured markers  102  can be oriented in the same longitudinal or radial direction (e.g., distally, proximally) along the wire body  104 . 
         [0069]      FIG. 20  illustrates that the markers  102  can have alphanumeric characters. The alphanumeric characters can increase in value (e.g., 1, 2, 3, or A, B, C, or I, II, III) incrementally along the length and/or radius of the wire. The markers  102  can include unit values (e.g., mm, in.) 
         [0070]      FIG. 21  illustrates that the markers  102  can be configured as a cylinder (e.g., disc), ring (e.g., toroid, band), partial cylinder, partial ring, or combinations thereof.  FIG. 22  illustrates that the markers  102  can be integrated with the measuring wire  100 .  FIG. 23  illustrates that the markers  102  can be wires or threads. The markers  102  can extend along the length and/or radius of the wire body  104 . 
         [0071]      FIG. 24  illustrates that the wire body  104  can have one or more hinges  106 . The hinges  106  can be configured to allow bending or other distortion of the wire body  104 . The hinges  106  can be a change in material and/or a configuration. The hinge  106  can be configured by material absent from a side of the wire body  104 . For example, the hinge  106  can be an angled cut (i.e., the angled cut is not necessarily cut. The angled cut can be cut, crimped, molded, etched, or combinations thereof) in the side of the wire body  104 . The hinge  106  can have a stop to limit the bending of the measuring wire  100 . For example, for an angle cut hinge  106 , the stop can be the side of the hinge  106 . The hinge  106  can have a hinge angle  62 . The hinge angle  62  can correlate to the maximum angle of bending. The hinge angle  62  can be, as described elsewhere herein, or from about 1° to about 179°, more narrowly from about 15° to about 90°, yet more narrowly from about 20° to about 60°, for example about 45°. 
         [0072]      FIG. 25  illustrates that the hinge  106  can be a round cut. For example, the hinge  106  can be circular (e.g., semi-circular), oval, or combinations thereof.  FIG. 26  illustrates that the hinge  106  can be a rectangular cut. For example, the hinge  106  can be rectangular (e.g., square). The hinge  106  can be any combination of the aforementioned configurations. The hinges  106  with various configurations can be on the same wire body  104 . The hinges  106  can be on various sides of, or otherwise distributed at various angles around, the measuring wire  100 . 
         [0073]      FIGS. 27 through 29  illustrate that the wire body  104  can be hollow. The measuring wire  100  can have one or more wire conduits  114  on the radial interior of the wire body  104 . The measuring wire  100  can have one or more wire conduit ports  110  in fluid communication with the one or more wire conduits  114  and the radial exterior of the measuring wire  100 . The wire conduit ports  110  can regulate release of material inside of the wire conduits  114 . For example, the wire conduit ports  110  (or wire conduits  114  themselves) can have and/or be filled and/or covered by an osmotic material, such as a matrix or film. The wire conduit ports  110  can all be on the same side of the measuring wire  100 . The wire conduit ports  110  can be on various sides of, or otherwise distributed at various angles around, the measuring wire  100 . 
         [0074]      FIG. 30  illustrates that a wire assembly  118  can have a measuring wire  100  connected to one or more other elements. The first measuring wire  100   a  can be connected to the second measuring wire  100   b  at a distal collar  122  and/or a proximal collar  124 . The first measuring wire  100   a  can be attached to and/or integral with the distal collar  122  and/or proximal collar  124 . The second measuring wire  100   b  can be attached to and/or integral with the distal collar  122  and/or proximal collar  124 . The wire assembly  118  can be made by being pressed, molded or cut from a tube, for example laser cut from a Nitinol tube. The collars can be cylindrical, have a rectangular, square, triangular, pentagonal, octagonal, oval cross section, or combinations thereof with respect to a longitudinal axis  16 . 
         [0075]      FIG. 31  illustrates that a wire sub-assembly  120  can have a first measuring wire  100   a  connected to one or more other elements. The first measuring wire  100   a  can be connected to a distal collar  122  and/or a proximal collar  124 . The first measuring wire  100   a  can be attached to and/or integral with the distal collar  122  and/or proximal collar  124 . The wire sub-assembly  120  can be made by being pressed, molded, or cut from a tube, for example laser cut from a Nitinol tube. 
         [0076]      FIG. 32  illustrates that the wire assembly  118  can have a first wire sub-assembly  134  and a second wire sub-assembly  136 . The first wire sub-assembly  134  and the second wire sub-assembly  136  can be integral and/or attached or separate. The first wire sub assembly can be positioned 180° opposite to the positioning of the second wire sub-assembly  136 , with respect to a longitudinal axis  16  of the wire assembly  118 . 
         [0077]      FIG. 33  illustrates that the wire assembly  118  can have a first measuring wire  100   a  that can have one or more hinges  106 . For example, the first measuring wire  100   a  can have a wire distal hinge  144  and/or a wire proximal hinge  142 . The wire distal hinge  144  can be at the connection between the first measuring wire  100   a  and the first wire distal collar  126 . The wire proximal hinge  142  can be at the connection between the first measuring wire  100   a  and the first wire proximal collar  128 . The wire distal hinge  144  and the wire proximal hinge  142  can be configured to bend or otherwise rotate the first measuring wire  100   a  radially outward from the central longitudinal axis  16  of the wire sub-assembly  120  when the measurement tool  2  is in a radially expanded configuration. 
         [0078]    The wire can have a wire first hinge  138  and/or a wire second hinge  140 . The wire first and/or second hinges can be on the first measuring wire  100   a,  for example, between the wire distal hinge  144  and the wire proximal hinge  142 . The wire first hinge  138  and/or the wire second hinge  140  can be configured to bend or otherwise rotate the first measuring wire  100   a  radially inward from the central longitudinal axis  16  of the wire sub-assembly  120  when the measurement tool  2  is in a radially expanded configuration. 
         [0079]      FIG. 34  illustrates that the wire assembly  118  can have wire distal hinges  144 , and/or wire proximal hinges  142 , and/or wire first hinges  138 , and/or wire second hinges  140  on the first measuring wire  100   a  and/or the second measuring wire  100   b.    
         [0080]      FIG. 35  illustrates that the measurement tool  2  can have a wire assembly  118  connected to the catheter  26 . The wire assembly  118  can be integrated and/or attached to the catheter  26 . For example, the proximal collar  124  and/or distal collar  122  can be integral with and/or fixably and/or slidably attached to the catheter  26 . For example, the distal collar  122  can be slidably attached to the catheter  26  near or on the tip  12  and/or the proximal collar  124  can be fixedly attached to the catheter  26 . 
         [0081]    The wire assembly  118  can have a retraction leader  148 . The retraction leader  148  can be integral with or attached to the distal collar  122 . The retraction leader  148  can be rigid and/or flexible. The retraction leader  148  can be radially external to the catheter  26  and/or the retraction leader  148  can be slidably attached to a retraction leader conduit  146  or channel inside of the catheter  26 . The retraction leader conduit  146  or channel can be partially or completely open to the radial outside of the catheter  26 . For example, the retraction leader conduit  146  can be open to the radial outside of the catheter  26  for all or part of the retraction leader conduit&#39;s  146  length distal to the proximal conduit. 
         [0082]      FIG. 36  illustrates that the first wire sub-assembly  134  and the second wire sub-assembly  136  can be integral with and/or attached to the catheter  26 . The first wire sub-assembly  134  can be proximal, distal, or overlapping with the longitudinal position of the second wire sub-assembly  136  on the catheter  26 . The second wire distal collar  130  can be distal and/or proximal to the first wire distal collar  126 . The second wire proximal collar  132  and be distal and/or proximal to the first wire proximal collar  128 . The first wire distal collar  126  can be attached to or integral with a first retraction leader  148 . The second wire distal collar  130  can be attached to or integral with a second retraction leader  148 . 
         [0083]      FIG. 37  illustrates that the measurement tool  2  can have a catheter sheath  152 . The catheter sheath  152  can be slidably attached to the catheter  26 . In an undeployed configuration, the catheter sheath  152  can be radially outside and longitudinally overlapping the wire assembly  118 . The catheter sheath  152  can be sufficiently rigid to retain the wire assembly  118  in a radially contracted configuration. The catheter sheath  152  can have, for example at a distal end of the catheter sheath  152 , a catheter sheath port  150  through which the catheter  26  and other elements (e.g., the wire assembly and measuring wires), can exit and enter the catheter sheath  152 . 
         [0084]    Any or all elements of the measurement tool  2  and/or other devices or apparatuses described herein can be made from, for example, a single or multiple stainless steel alloys, nickel titanium alloys (e.g., Nitinol), cobalt-chrome alloys (e.g., ELGILOY® from Elgin Specialty Metals, Elgin, Ill.; CONICHROME® from Carpenter Metals Corp., Wyomissing, Pa.), nickel-cobalt alloys (e.g., MP35N® from Magellan Industrial Trading Company, Inc., Westport, Conn.), molybdenum alloys (e.g., molybdenum TZM alloy, for example as disclosed in International Pub. No. WO 03/082363 A2, published 9 Oct. 2003, which is herein incorporated by reference in its entirety), tungsten-rhenium alloys, for example, as disclosed in International Pub. No. WO 03/082363, polymers such as polyethylene teraphathalate (PET), polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, aromatic polyesters, such as liquid crystal polymers (e.g., Vectran, from Kuraray Co., Ltd., Tokyo, Japan), ultra high molecular weight polyethylene (i.e., extended chain, high-modulus or high-performance polyethylene) fiber and/or yarn (e.g., SPECTRA® Fiber and SPECTRA® Guard, from Honeywell International, Inc., Morris Township, N.J., or DYNEEMA® from Royal DSM N.V., Heerlen, the Netherlands), polytetrafluoroethylene (PTFE), expanded PTFE (ePTFE), polyether ketone (PEK), polyether ether ketone (PEEK), poly ether ketone ketone (PEKK) (also poly aryl ether ketone ketone), nylon, polyether-block co-polyamide polymers (e.g., PEBAX® from ATOFINA, Paris, France), aliphatic polyether polyurethanes (e.g., TECOFLEX® from Thermedics Polymer Products, Wilmington, Mass.), polyvinyl chloride (PVC), polyurethane, thermoplastic, fluorinated ethylene propylene (FEP), absorbable or resorbable polymers such as polyglycolic acid (PGA), poly-L-glycolic acid (PLGA), polylactic acid (PLA), poly-L-lactic acid (PLLA), polycaprolactone (PCL), polyethyl acrylate (PEA), polydioxanone (PDS), and pseudo-polyamino tyrosine-based acids, extruded collagen, silicone, zinc, echogenic, radioactive, radiopaque materials, a biomaterial (e.g., cadaver tissue 154, collagen, allograft, autograft, xenograft, bone cement, morselized bone, osteogenic powder, beads of bone) any of the other materials listed herein or combinations thereof. Examples of radiopaque materials are barium sulfate, zinc oxide, titanium, stainless steel, nickel-titanium alloys, tantalum and gold. 
         [0085]    Any or all elements of the measurement tool  2  and/or other devices or apparatuses described herein, can be, have, and/or be completely or partially coated with agents and/or a matrix a matrix for cell ingrowth or used with a fabric, for example a covering (not shown) that acts as a matrix for cell ingrowth. The matrix and/or fabric can be, for example, polyester (e.g., DACRON® from E. I. Du Pont de Nemours and Company, Wilmington, Del.), polypropylene, PTFE, ePTFE, nylon, extruded collagen, silicone or combinations thereof. 
         [0086]    The measurement tool  2  and/or elements of the measurement tool  2  and/or other devices or apparatuses described herein and/or the fabric can be filled, coated, layered and/or otherwise made with and/or from cements, fillers, glues, and/or an agent delivery matrix known to one having ordinary skill in the art and/or a therapeutic and/or diagnostic agent. Any of these cements and/or fillers and/or glues can be osteogenic and osteoinductive growth factors. 
         [0087]    Examples of such cements and/or fillers includes bone chips, demineralized bone matrix (DBM), calcium sulfate, coralline hydroxyapatite, biocoral, tricalcium phosphate, calcium phosphate, polymethyl methacrylate (PMMA), biodegradable ceramics, bioactive glasses, hyaluronic acid, lactoferrin, bone morphogenic proteins (BMPs) such as recombinant human bone morphogenetic proteins (rhBMPs), other materials described herein, or combinations thereof. 
         [0088]    The agents within these matrices can include any agent disclosed herein or combinations thereof, including radioactive materials; radiopaque materials; cytogenic agents; cytotoxic agents; cytostatic agents; thrombogenic agents, for example polyurethane, cellulose acetate polymer mixed with bismuth trioxide, and ethylene vinyl alcohol; lubricious, hydrophilic materials; phosphor cholene; anti-inflammatory agents, for example non-steroidal anti-inflammatories (NSAIDs) such as cyclooxygenase-1 (COX-1) inhibitors (e.g., acetylsalicylic acid, for example ASPIRIN® from Bayer AG, Leverkusen, Germany; ibuprofen, for example ADVIL® from Wyeth, Collegeville, Pa.; indomethacin; mefenamic acid), COX-2 inhibitors (e.g., VIOXX® from Merck &amp; Co., Inc., Whitehouse Station, N.J.; CELEBREX® from Pharmacia Corp., Peapack, N.J.; COX-1 inhibitors); immunosuppressive agents, for example Sirolimus (RAPAMUNE®, from Wyeth, Collegeville, Pa.), or matrix metalloproteinase (MMP) inhibitors (e.g., tetracycline and tetracycline derivatives) that act early within the pathways of an inflammatory response. Examples of other agents are provided in Walton et al, Inhibition of Prostoglandin E 2  Synthesis in Abdominal Aortic Aneurysms,  Circulation,  Jul. 6, 1999, 48-54; Tambiah et al, Provocation of Experimental Aortic Inflammation Mediators and Chlamydia Pneumoniae,  Brit. J. Surgery  88 (7), 935-940; Franklin et al, Uptake of Tetracycline by Aortic Aneurysm Wall and Its Effect on Inflammation and Proteolysis,  Brit. J. Surgery  86 (6), 771-775; Xu et al, Sp1 Increases Expression of Cyclooxygenase-2 in Hypoxic Vascular Endothelium,  J. Biological Chemistry  275 (32) 24583-24589; and Pyo et al, Targeted Gene Disruption of Matrix Metalloproteinase-9 (Gelatinase B) Suppresses Development of Experimental Abdominal Aortic Aneurysms,  J. Clinical Investigation  105 (11), 1641-1649 which are all incorporated by reference in their entireties. 
       Methods of Use 
       [0089]      FIG. 38   a  illustrates a section of tissue  154  that can have a tunnel defect  156  passing through the tissue  154 . The tunnel defect  156  can be substantially perpendicular to the face of the tissue  154 . For example, the tunnel defect  156  can be an atrial septal defect (ASD).  FIG. 38   b  illustrates that the tunnel defect  156  can be at a steep angle or substantially parallel to the face of the tissue  154 . For example, the tunnel defect  156  can be a patent foramen ovale (PFO). 
         [0090]      FIG. 39  illustrates that the tunnel defect  156  can have a defect front face  162  and a defect back face (not shown). A defect front lip  160  can be defined by the perimeter of the defect front face  162 . A defect back lip  158  can be defined by the perimeter of the defect back face. The tunnel defect  156  can have a defect height  164 , a defect depth  166  and a defect width  168 . 
         [0091]      FIG. 40  illustrates that a guidewire  170  can be deployed through the tunnel defect  156 . The guidewire  170  can be passed through the guide lumen  4  in the measurement tool  2 . The measurement tool  2  can be in a radially contracted (as shown) or radially expanded configuration. The measurement tool  2  can be translated, as shown by arrow, along the guidewire  170 . The measurement tool  2  can be translated to the tunnel defect  156  with or without the use of the guidewire  170 . 
         [0092]      FIG. 41  illustrates that the measurement tool  2  can be translated into the tunnel defect  156 . The guidewire  170  can be left in place or removed. The location of the measurement tool  2  can be monitored by dead reckoning, and/or imaging, and/or tracking along the length of the guidewire  170 . The measurement tool  2  can be positioned so that the tunnel defect  156  is located adjacent to the catheter porous section  20 . The measurement tool  2  can be positioned so that the tunnel defect  156  is located substantially between the most distal wire distal anchor  14  and the most proximal wire proximal sheath. 
         [0093]      FIG. 42  illustrates that the measurement tool  2  can be radially expanded. The measuring wires  100  in the wire radially constrained section  10  can be distally longitudinally translated, as shown by arrow  54 . The measuring wires  100  can translate radially (i.e., away from the longitudinal axis  16 ), as shown by arrows  52 . The measuring wires  100  can radially distend the tunnel defect  156 , for example causing the tunnel defect  156  to widen (shown by arrows similar to arrows  52 ) and shorten or otherwise contract in height, as shown by arrows  172 . The measuring wires  100  can radially distend the tunnel defect  156 , for example, until the tunnel defect  156  will no longer distend without structurally damaging the tunnel defect  156 . 
         [0094]      FIG. 43  illustrates that the measuring wires  100  can be radially translated beyond the extent that the tunnel defect  156  can be distended without structural damage. The measuring wires  100  can deform around the front and back defect lips. Portions of the measuring wires  100  can configure into wire overdeployment sections  176  proximal and distal to the tunnel defect  156 . The wire overdeployment sections  176 , or markers  102  thereon, can be imaged, for example using x-rays (e.g., radiography, fluoroscopy), ultrasound, or magnetic resonance imaging (MRI). The wire overdeployment sections  176  can illustrate the defect width  168  (i.e., the length between the wire deployment sections) when the defect is in a fully distended configuration. 
         [0095]      FIG. 44  illustrates that the measurement tool  2  can have no catheter porous section  20 , for example, when the measurement tool  2  is used for the measurement method as shown in  FIG. 43 . The methods of use shown in  FIGS. 43 and 44  can, for example, measure the defect depth  166  and/or the defect height  164 . 
         [0096]      FIG. 45  illustrates that contrast fluid or particles can be deployed into the fluid lumen  36  of the catheter  26 , for example, when tunnel defect  156  is in a fully distended configuration. The contrast fluid can be radiopaque, echogenic, visible contrast (e.g., dyes, inks), any other material disclosed herein, or combinations thereof. The fluid pressure of the contrast fluid or particles can be increased. The contrast fluid or particles can emit, as shown by arrows  180 , through the catheter porous section  20 . The contrast fluid or particles outside of the catheter  26  can configure into a marker cloud  178 . The marker cloud  178  can move into position around the tissue  154 . The marker cloud  178  can illustrate the defect dimensions (i.e., visible with imaging systems known to those having ordinary skill in the art, including x-ray, CAT, MRI, fiber optic camera, ultrasound/sonogram) when the defect is in a fully distended configuration. 
         [0097]    A drug can be deployed from the catheter porous section  20 , for example, similar to the method of deploying the contrast fluid. 
         [0098]      FIG. 46  illustrates that a proximal force, as shown by arrows, can be applied to the distal collar  122 . For example, the retraction leader  148  can be pulled proximally. 
         [0099]      FIG. 47  illustrates that the distal collar  122  can translate proximally, as shown by arrows  52 . The measuring wires  100  can expand radially away from the central longitudinal axis  16  of the measurement tool  2 . The wires can bend radially outward at the wire distal hinge  144  and the wire proximal hinges  142 . The wires can bend radially inward at the wire first hinge  138  and wire second hinge  140 . The wires can also form a curved or splined configuration (e.g., similar to the configuration shown in  FIG. 6 , inter alia) instead of or in addition to the hinges  106 . 
         [0100]    The measuring wires  100  can be resiliently biased to the radially contracted configuration. When the proximal force is no longer applied to the distal collar  122 , the measuring wires  100  can straighten and distally force the distal collar  122  to translate to the position shown in  FIG. 46 . 
         [0101]    The measurement wires can be deformable. The retraction leader  148  can be rigid. For example, to radially contract the measuring wires  100 , the retraction leader  148  can distally force the distal collar  122  to translate to the position shown in  FIG. 46 . The measuring wires  100  can deform to the position shown in  FIG. 46 . 
         [0102]      FIG. 48  illustrates that the wire assembly  118  can be radially constrained by the catheter sheath  152 . The catheter sheath  152  can radially encircle the measuring wires  100  and/or the entire wire assembly  118 . The catheter sheath  152  can longitudinally encompass the measuring wires  100  and/or the entire wire assembly  118 . A distal force, as shown by arrows, can be applied to the catheter sheath  152 . 
         [0103]      FIG. 49  illustrates that the measuring wires  100  can be resiliently biased to radially expand away from the center longitudinal axis  16  of the measurement tool  2 . When the catheter sheath  152  is retracted distal to the measuring wires  100 , the measuring wires  100  can radially expand, as shown by arrows. The distal collar  122  can proximally translate, as shown by arrows. 
         [0104]    The catheter sheath  152  can be rigid. The catheter sheath  152  can be distally translated, for example to radially contract the measuring wires  100 . The catheter sheath  152  can radially contract the measuring wires  100  as the catheter sheath  152  substantially underformably slides distally over the measuring wires  100 . 
         [0105]    A distension device size can be determined as described, supra. The measurement tool  2  can be radially contracted and removed from the tunnel defect  156 , or the coupler  96  and/or the elements of the measurement tool  2  proximal to the coupler  96  can be detached from the remainder of the measurement tool  2  and removed. If the entire measurement tool  2  is removed from the tunnel defect  156 , a distension device can be selected that has a size that substantially matches (e.g., is equivalent when the distension device is in a substantially or completely radially expanded configuration) the size of the distended tunnel defect  156 . The distension device can be deployed to the tunnel defect  156 , for example along the guidewire  170 . The guidewire  170  can be removed. The distension device can be, for example, a filter, stopper, plug, any distending device described in U.S. patent application Ser. No. 10/847,909, filed 19 May 2004; Ser. No. 11/184,069, filed 19 Jul. 2005; and Ser. No. 11/323,640, filed 3 Jan. 2006, all of which are incorporated by reference herein in their entireties, or any combinations thereof. 
         [0106]    Any elements described herein as singular can be pluralized (i.e., anything described as “one” can be more than one). Any species element of a genus element can have the characteristics or elements of any other species element of that genus. The above-described configurations, elements or complete assemblies and methods and their elements for carrying out the invention, and variations of aspects of the invention can be combined and modified with each other in any combination.

Technology Classification (CPC): 0