Source: http://www.patentsencyclopedia.com/app/20100022948
Timestamp: 2017-09-22 22:04:51
Document Index: 77434729

Matched Legal Cases: ['art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1', 'art 1']

Steerable Catheter and Dilator and System and Method for Implanting a Heart Implant - Patent application
Patent application title: Steerable Catheter and Dilator and System and Method for Implanting a Heart Implant
Inventors: Jonathan E. Wilson (Amesbury, MA, US) Jonathan E. Wilson (Amesbury, MA, US) Robert J. St. John (Mansfield, MA, US) Eric W. Conley (South Berwick, ME, US)
Patent application number: 20100022948
Steerable Catheter and Dilator and System and Method for Implanting a Heart Implant - Patent application <?php require_once('/home/patents/php/mtc.config.php'); require_once('/home/patents/php/mtc.class.php'); $MTC = new MTC(); $MTC->init(); ?>
Inventors: Jonathan E. Wilson Robert J. St. John Eric W. Conley
1. A catheter configured to extend through a transseptal puncture site, a left atrium, and into a left ventricle, said catheter comprising:a shaft defining at least one lumen configured to receive at least one of an implant and/or a dilator;a first steerable actuator coupled to said shaft at a position on said shaft substantially corresponding to said transseptal puncture site when a distal end of said shaft is disposed within said left ventricle; anda handle assembly coupled to a proximal end of said shaft, said handle assembly comprising a first actuator coupled to said first steerable actuator, said first actuator configured to apply a force to said first steerable actuator to deflect said shaft about a region proximate to said first steerable actuator.
[0001]The present application is a continuation-in-part of U.S. patent application Ser. No. 12/209,686 filed Sep. 12, 2008, which claims the benefit of U.S. Provisional Application Ser. No. 61/061,343, filed Jun. 13, 2008, both of which are hereby incorporated fully by reference.
[0017]FIG. 11 illustrates a perspective view of an embodiment of a dilator advanced to the left atrium consistent with the present disclosure;
[0018]FIG. 12 illustrates a perspective view of one embodiment of a dilator consistent with the present disclosure;
[0019]FIG. 13A illustrates a perspective view of an embodiment of a dilator consistent with the present disclosure;
[0020]FIG. 13B illustrates a close-up of one embodiment of the tip of the dilator shown in FIG. 13A consistent with the present disclosure;
[0021]FIG. 14A illustrates a perspective view of a yet another embodiment of a dilator consistent with the present disclosure;
[0022]FIG. 14B illustrates a perspective view of one embodiment of the dilator shown in a deflected or retracted position consistent with the present disclosure;
[0023]FIG. 14C illustrates a perspective view of one embodiment of the dilator shown in an inflated or expanded position consistent with the present disclosure;
[0024]FIG. 15 illustrates a perspective view of a dilator in the inflated or expanded position located in the left atrium consistent with the present disclosure;
[0025]FIG. 16 illustrates a perspective view of a dilator in the inflated or expanded position located in the left atrium prior to passing through the mitral valve consistent with the present disclosure;
[0026]FIG. 17 illustrates a perspective view of a dilator located in the left ventricle consistent with the present disclosure;
[0027]FIG. 18 illustrates a perspective view of an embodiment of a steerable catheter advanced over the dilator in the left ventricle consistent with the present disclosure;
[0028]FIG. 19 illustrates a perspective view of one embodiment of a steerable catheter consistent with the present disclosure;
[0029]FIGS. 20A-D illustrate various views of another embodiment of a steerable catheter consistent with the present disclosure;
[0030]FIG. 21 illustrates a perspective view of an embodiment of a steerable catheter in a non-deflected position consistent with the present disclosure;
[0031]FIG. 22 illustrates a perspective view of an embodiment of a steerable catheter with the distal tip in a deflected position consistent with the present disclosure;
[0032]FIG. 23 illustrates a perspective view of an embodiment of a steerable catheter with the proximal tip in a deflected position consistent with the present disclosure;
[0033]FIG. 24 illustrates a perspective view of an embodiment of a steerable catheter with the distal tip and the proximal tip in a deflected position consistent with the present disclosure;
[0034]FIG. 25 illustrates a perspective view of an embodiment of a steerable catheter advanced in the left ventricle with an implant loaded consistent with the present disclosure;
[0035]FIG. 26 illustrates a perspective view of an embodiment of a steerable catheter being aimed or aligned with the implant site consistent with the present disclosure;
[0036]FIG. 27 illustrates a perspective view of an embodiment of a steerable catheter advanced to the implant site consistent with the present disclosure; and
[0037]FIGS. 28-30 illustrate one embodiment of a withdrawal sequence for a steerable catheter consistent with the present disclosure.
[0038]The present disclosure relates to a system and method of implanting a heart implant. For example, the system and method according to one embodiment of the present disclosure may be used to implant a heart valve implant which may suitably be used in connection with the treatment, diagnostics and/or correction of a dysfunctional or inoperative heart valve. One suitable implementation for a heart valve implant consistent with the present disclosure is the treatment of mitral valve regurgitation. For the ease of explanation, the heart valve implant herein is described in terms of a mitral valve implant, such as may be used in treating mitral valve regurgitation as described in U.S. patent No. application Ser. No. 11/258,828 filed Oct. 26, 2005 and U.S. patent application Ser. No. 12/209,686 filed Sep. 12, 2008, both of which are fully incorporated herein by reference. However, a heart valve implant consistent with the present disclosure may be employed for treating, diagnosing and/or correcting other dysfunctional or inoperative heart valves. The present disclosure should not, therefore, be construed as being limited to use as a mitral valve implant. In addition, the system and method according to the present disclosure may be used to implant heart implants configured to be used in connection with the treatment, diagnostics and/or correction of other heart conditions. For example, and without limitation, the system and method consistent with the present disclosure may be used to implant a regurgitation implant configured to induce a controlled regurgitation in a heart valve (such as, but not limited to, a mitral heart valve), for example, in a manner that is generally consistent with advanced disease of the heart. The regurgitation implant may include a regurgitation implant as described in U.S. patent No. Ser. No. 11/940,724 filed Nov. 15, 2007 and U.S. patent application Ser. No. 12/209,686 filed Sep. 12, 2008, both of which are fully incorporated herein by reference.
[0039]According to one embodiment, a heart implant consistent with the present disclosure may comprise a heart valve implant configured to interact with at least a portion of an existing heart valve to prevent and/or reduce regurgitation. For example, at least a portion of one or more cusps of the heart valve may interact with, engage, and/or seal against at least a portion of the heart valve implant when the heart valve is in a closed condition. The interaction, engagement and/or sealing between at least a portion of at least one cusp and at least a portion of the heart valve implant may reduce and/or eliminate regurgitation in a heart valve, for example, providing insufficient sealing, including only a single cusp, e.g., following removal of a diseased and/or damaged cusp, and/or having a ruptured cordae. A heart valve implant consistent with the present disclosure may be used in connection with various additional and/or alternative defects and/or deficiencies.
[0040]For the ease of explanation, one embodiment of the system and method consistent with the present disclosure is described in terms of a system and method for implanting a mitral valve implant, such as may be used in treating mitral valve regurgitation. By way of an overview, the system and method may generally comprise placing a guide wire into the left ventricle and advancing a mitral valve implant through a delivery catheter and into the left ventricle. For example, a guide wire may be initially placed into the left atrium of the heart, for example, by way of transseptal puncture of the heart from the right atrium through the fossa ovalis into the left atrium. A dilator may then be advanced along the guide wire to the left atrium and may be passed through the mitral valve into the left ventricle. The dilator may include a balloon which may be inflated to facilitate passing the dilator through the mitral valve without damaging the mitral valve or becoming entangled in the mitral valve. A steerable catheter may then be advanced along the dilator into the left ventrical. The steerable catheter may be positioned within the left ventrical to the approximate location in which the implant will be secured. The implant may then be advanced through the steerable catheter and secured to the native cardiac tissue.
[0041]Referring now to FIG. 1, a cross-sectional schematic view of a portion of a four chamber heart 1 is illustrated. The outflow tracts of the right and left ventricles 2, 3 are not shown in order to better illustrate the septum 4 between the right and left atria 5, 6. As shown, the inferior vena cava (IVC) 7 and superior vena cava (SVC) 8 communicate with the right atrium 5 which is separated from the left atrium 6 by the intra-atrial septum 4. While not a limitation of the present disclosure, it is may be advantageous to make the transseptal puncture 13 through the fossa ovalis 9 since the fossa ovalis 9 is thinnest portion of the intra-atrial septum 4.
[0042]According to one embodiment consistent with the present disclosure, a guide wire 10 may be advanced up the IVC 7 and into the right atrium 5. The guide wire 10 may include any guide wire configured to be advanced up the IVC 7 and into the right atrium 5. Consistent with one embodiment, the guide wire 10 may be the same as the delivery guide wire discussed herein; however, the guide wire 10 may also be separate and distinct from the delivery guide wire. Without limitation, access to the right atrium 5 may be accomplished by way of the Seldinger wire technique. For example, the right femoral vein (not shown) may be accessed with a hollow needle (not shown) and a guide wire 10 may be inserted. The needle may be removed and a dilator 16 may be inserted over the guide wire 10. The sheath 18 of a catheter 20 (such as, but not limited to, a Mullins catheter or the like) having a pre-bent region 21 proximate the distal tip 23 of the catheter 20 may be inserted over the dilator 16. The sheath 18, dilator 16, catheter 20 and guide wire 10 may then be advanced up the IVC 7 through the opening 22 into the right atrium 5 as generally illustrated in FIG. 1.
[0043]With the sheath 18, dilator 16, catheter 20 and guide wire 10 in the right atrium 5, access to the left atrium 6 may be achieved by transseptal puncture 13 from the right atrium 5 through the intra-atrial septum 4. For example, at least a portion of the guide wire 10 may be advanced out of the distal tip 23 of the dilator 16, sheath 18 and/or catheter 20 as generally shown in FIG. 2. According to an embodiment, the guide wire 10 may be at least partially advanced into the SVC 8 as generally illustrated in FIG. 2 and the distal tip 23 of the catheter 20 may then be at least partially advanced along the guide wire 10 into the SVC 8 as generally illustrated in FIG. 3. Because the SVC 8 is a thin-walled vein, it may be advantageous to place the guide wire 10 in the SVC 8 and then advance the catheter 20 along the guide wire 10 since the spring-tipped atraumatic guide wire 10 reduces the potential for damaging the SVC 8 compared to the catheter 20 and dilator 16.
[0044]With the distal tip 23 at least partially received in the SVC 8, the guide wire 10 may be retracted into the dilator 16 and the catheter 20 may be retracted (i.e., pulled downward) such that the pre-bent portion 21 of the sheath 18 facilitates guiding the distal tip 23 to the fossa ovalis 9 as generally illustrated in FIG. 4. For example, using one or more visualization techniques (such as, but not limited to, intracardiac echo (ICE), fluoroscopy, and the like), the sheath 18 may be retracted proximally, dragging the distal tip 23 along the intra-atrial septum 4 until the distal tip 23 is positioned proximate to the fossa ovalis 9. Optionally, the position of the sheath 18 relative to the fossa ovalis 9 may be confirmed by gently pushing the sheath 18 distally against the intra-atrial septum 4 to "tent" the fossa ovalis 9 as generally illustrated in FIG. 5. The "tenting" of the fossa ovalis 9 may be seen on ICE, fluoroscopy or the like.
[0045]With the distal tip 23 proximate and/or contacting the fossa ovalis 9, the guide wire 10 may be removed from the catheter 20 and a transseptal needle 26 may be advanced through the catheter 20 towards the distal end 23 of the catheter 20 as generally shown in FIG. 6. The position of the catheter 20 may optionally be confirmed (for example, but not limited to, by "tenting") and the transseptal needle 26 may be advanced out of the distal tip 23 to form a puncture 28 through the fossa ovalis 9 and into the left atrium 6. The sheath 16, dilator 28 and catheter 20 may than be advanced through the puncture 28 of the fossa ovalis 9 and into the left atrium 6 as generally shown in FIG. 7. Once the sheath 16, dilator 28 and catheter 20 are through the fossa ovalis 9, the needle 26 may be removed from the catheter 20 as generally shown in FIG. 8.
[0046]With the catheter 20 in the left atrium 6, a delivery guide wire 30 may be advanced through the catheter 20 until at least a portion of the distal tip 32 of the delivery guide wire 30 extends from the distal tip 23 of the catheter 20 and into the left atrium 6 as generally illustrated in FIG. 9. Once the distal tip 32 of the delivery guide wire 30 is disposed in the left atrium 6, the dilator 16 and the sheath 18 may be removed, leaving just the delivery guide wire 30 in the left atrium 6 as generally illustrated in FIG. 10.
[0047]The delivery guide wire 30 may be used as a guide for advancing other devices into the heart 1, and ultimately, into the left ventricle 3. Accordingly to at least one embodiment, the delivery guide wire 30 may be sufficiently stiff to resist undesirable bending and/or kinking and to resist undesirable movement of the distal tip 32. For example, the delivery guide wire 30 may comprise a stiff, 0.018'' diameter guide wire having a stiffness of approximately 19,900,000 psi. The stiffness of the delivery guide wire 30 was determined as follows.
[0048]When a force is applied to a long thin column, there is no movement of the column until a minimum critical buckling force is achieved, Pcr, then further buckling occurs, though the force does not increase. For a long column of uniform cross-section and length 1, which buckles under a critical force, Pcr, the following formula applies:
P cr = n π 2 EI L 2 ##EQU00001## [0049]Where: [0050]n=a constant that is equal to 4 if both ends of the column are clamped and cannot move or rotate. [0051]E=Modulus of elasticity of the material (psi) [0052]I=Moment of inertia (in4)For a circular cross-section the moment of inertia is:
[0052] I = π d 4 64 ##EQU00002##
[0053]Based on the above, an 8 cm section of the delivery guide wire 30 was tested and a buckling force of 0.41 lbs. was determined. Therefore,
[0054]According to at least one other embodiment, the delivery guide wire 30 may include a typical 0.018'' guide wire (for example a 0.018'' angled standard exchange guide wire made by Merit Medical Systems of South Jordan, Utah, Model H20STDA18260EX which was determined to have a stiffness of approximately 1,360,000 psi based on the same methodology). In either embodiment, the delivery guide wire 30 may have a diameter greater than or less than 0.018''.
[0055]Turning now to FIG. 11, a dilator 34 may be advanced over the delivery guide wire 30 into the left atrium 6. The dilator 34 may be configured to pass through the mitral valve 61 into the left ventricle 3 without damaging the mitral valve 61 or becoming entangled in the mitral valve 61 (for example, the cusps 66, the chordae and/or papillary muscles 68 of the mitral valve 61). According to at least one embodiment, the dilator 34 of the present disclosure may be used to eliminate the rail as disclosed in U.S. patent application Ser. No. 12/209,686 filed Sep. 12, 2008. However, it may be appreciated that the system and method disclosed in the present disclosure (and in particular the dilator 34) is not inconsistent with the system and method in U.S. patent application Ser. No. 12/209,686, and as such, the system and method disclosed in the present disclosure (including the dilator 34) may be used in conjunction with the system and method in U.S. patent application Ser. No. 12/209,686.
[0056]One embodiment of a dilator 34a consistent with the present disclosure is generally illustrated in FIG. 12. The dilator 34a may include define at least one lumen 94 configured to receive at least a portion of the delivery guide wire 30. For example, the lumen 94 may have an internal diameter of approximately 0.038''. The dilator 34a may also comprise a shaft 96 including a tapered tip region 98. The shaft 96 may comprise a plurality of segments or portions having different stiffness or hardness to produce the desired overall curvature. The shaft 96 may be formed from one or more suitable polymers such as, but not limited to, a polyether block amide. The shaft 96 may have a constant inner and/or outer diameter and may be made from different materials to provide the various stiffness or hardness. Alternatively, or in addition, the shaft 96 may have different inner and/or outer diameters and may be made from one or more materials. For example, the various stiffness or hardness of the shaft 96 may be provided by varying the thickness of the shaft 96 at the different segments or portions. The different hardness of the segments may provide differing degrees of bending stiffness to the dilator 34a which may facilitate advancing the dilator 34a into and/or out of the left ventricle 3.
[0057]As shown, the dilator 34a may comprise four different segments 97a, 97b, 97c and 97d. The first segment 97a may be disposed proximate the distal end region 98. The first segment 97a may optionally include the tapered distal tip 98 and may have a length of approximately 6 inches. The tapered distal tip 98 may be provided to facilitate advancing the tip 98 into the percutaneous puncture site in the groin as the dilator 34a is introduced over the delivery guide wire 30.
[0058]According to at least one embodiment, the first segment 97a may be formed of PEBAX® 3533 having a durometer of 35 D. The second segment 97b may be adjacent to the first segment 97a and may have a length of approximately 1.5 inches. According to at least one embodiment, the second segment 97b may be formed of PEBAX® 2533 having a durometer of 25 D. The third segment 97c may be adjacent to the second segment 97b and may have a length of approximately 2 inches. According to at least one embodiment, the third segment 97c may be formed of PEBAX® 3533 having a durometer of 35 D. The forth segment 97d may be adjacent to the third segment 97c and may have a length of approximately 42.5 inches. According to at least one embodiment, the forth segment 97d may be formed of PEBAX® 7233 having a durometer of 72 D.
[0059]It should be understood that the various lengths and hardness described above for the segments 97a-97d may be adjusted or changed depending upon the circumstances of its intended use. For example, patients with larger and/or smaller hearts may require one or more of the segments to be harder or softer. An important aspect of the segments 97a-97d is that the softest segment is the second segment 97b. Also, the second segment 97b is disposed approximately 6 inches from the tapered distal tip 98. As will be explained herein, the location of the second segment 97b may generally correspond to the of the transseptal puncture site 13 where the curvature of the dilator 34a may be greatest.
[0060]Turning now to FIGS. 13A and 13B, another embodiment of a dilator 34b consistent with the present disclosure is generally illustrated. The dilator 34 may include a deflectable tip 98a configured to allow the user to bend the distal region 109 of the dilator 34b. The deflectable tip 98a may facilitate advancement of the dilator 34b through the mitral valve 61 may allowing the user to generally aim the tip 98 towards the mitral valve 61. According to at least one embodiment, the dilator 34b may include a handle assembly 102 coupled to a proximal end 104 of the shaft 96a. The shaft 96a may include a plurality of segments, for example, the segments 97a-97d described above. One or more deflecting wires 106 may be coupled to the distal end region 109 of the shaft 96a, for example, as generally illustrated in FIG. 13B. The defecting wire 106 may optionally be disposed in a second lumen 113 disposed along the length of the shaft 96a. Additional defecting wires 106 (not shown) may be provided in one or more additional lumens.
[0061]The defecting wire 106 may be coupled to the handle assembly 102 such that the distal tip 98a may be bent as desired. According to one embodiment, the handle assembly 102 may include at least one knob, slider or the like 115 coupled to the defecting wire 106 such that actuation of the knob 115 may result in movement of the distal tip 98a. For example, the knob 115 may be coupled to the defecting wire 106 and may pull the defecting wire 106 generally towards the handle assembly 102 causing the distal tip 98a to bend to one side.
[0062]The handle assembly 102 may also optionally include one or more valves or fittings. For example, the handle assembly 102 may include a fitting 111 (such as, but not limited to, a Luer lock fitting or the like) configured to allow the lumen 97 to be flushed. The handle assembly 102 may also optionally include a valve 112 (such as, but not limited to, a hemostasis valve) configured to seal with the delivery guide wire 30 (not shown).
[0063]The lumen 97 may have various diameters along the length of the shaft 96a. For example, the lumen 97 may have a smaller diameter proximate the distal tip 98a compared to the remainder of the shaft 96a. The lumen 97 proximate the tip 98a may be slightly larger than the diameter of the delivery guide wire 30 (for example, but not limited to, slightly larger than 0.018'') such that the dilator 34a tracks well over the delivery guide wire 30. The remainder of the lumen 97 may have a larger diameter configured to reduce drag as the dilator 34a is advanced over the delivery guide wire 30.
[0064]Turning now to FIGS. 14A-14C, yet another embodiment of a dilator 34c consistent with the present disclosure is generally illustrated. The dilator 34c may comprise an expandable device 114 (such as, but not limited to a balloon or the like) configured to facilitate advancement of the dilator 34c through the mitral valve 61 without damaging the mitral valve 61 or becoming entangled in the mitral valve 61 (for example, the cusps 66, the chordae and/or papillary muscles 68 of the mitral valve 61). The expanding portion 114 may be disposed proximate the distal end region 109 of the shaft 96b, for example, substantially adjacent to the tapered tip 98a. The expanding portion 114 may be fluidly coupled to an expanding medium such as, but not limited to, a gas and/or liquid which may expand and/or enlarge the expanding portion 114 from the deflated or retracted position as generally illustrated in FIG. 14B to the inflated or expanded position as generally illustrated in FIG. 14A. According to at least one embodiment, the expanding medium may include carbon dioxide CO2 gas and/or saline. Optionally, contrast media may be introduced into the expanding portion 114 to allow the expanding portion 114 to be more easily visually located using fluoroscopy or the like. The contrast media may coat the inside surface of the expanding portion 114.
[0065]The expanding medium may be introduced through a fitting 111. According to at least one embodiment, the expanding medium may be coupled to the expanding portion 114 by way of the lumen 116a as generally illustrated in FIG. 14C. As may be appreciated, the delivery guide wire 30 may be received in the lumen 97 when the dilator 34c is expanded. The expanding medium may be coupled to the expanding portion 114 by way of a separate passageway (i.e., a passageway different from the lumen 97 configured to receive the delivery guide wire 30). This passageway may be the same lumen as the steering wire 106 is housed in, provided there is enough room for the expansion medium to pass around the steering wire.
[0066]The expanding portion 114 may include a resiliently expandable/collapsible material such as, but not limited to, silicone, Yulex® or the like which may be selectively collapsed and/or expanded. The expanding portion 114 may be bonded to the shaft 96b of the dilator 34c and may include one or more passageways, aperture or lumen 116 fluidly coupled to the lumen 97 to allow the expansion medium to expand/collapse the expanding portion 114. The diameter of the expanding portion 114 should be small enough in the first or retracted/collapsed position to be advanced over the delivery guide wire 30 to the left atrium 6 and large enough when in the second or expanded/inflated position to be advanced through the cusps 66 and chordae 68 of the mitral valve 61 to reduce the potential of damaging the heart 1 and/or getting entangled within the mitral valve 61. For example, the shaft 97 may have an outer diameter of approximately 0.062'' (e.g., a 5 Fr) and a length of approximately 110 cm or greater. The expanding portion 114 may diameter of approximately 0.100'' in the first position and a diameter of approximately 15 mm to approximately 20 mm cm in the second position with a length of approximately 8 to approximately 10 mm.
[0067]The dilator 34c may optionally include a deflectable tip 98a configured to allow the user to bend the distal region 109 of the dilator 34b as generally described herein. The dilator 34c may also optionally include one or more radiopaque markers 118a-118n, for example, disposed about the distal end region 109. The position markers 118a-118n may be spaced evenly along the shaft 97 (such as, but not limited to, approximately 2 cm intervals from the distal tip 98a) and may be used to verify the position of the dilator 34c and/or for sizing the implant to be delivered.
[0068]While various embodiments of the dilator 34 consistent with the present disclosure have been described herein, it should be understood that one or more features of any of the various embodiments may be combined with any other embodiment. The dilator 34 consistent with he present disclosure may have an overall length (i.e., from the distal tip 98 to the handle assembly 102 of approximately 145 cm or less. However, the length and/or the diameter of the dilator 34 may depend upon the introduction site as well as the intended patient's physiology.
[0069]Turning now to FIG. 15, the dilator 34 may be advanced over the delivery guide wire 30 proximate to the tip 32 of the delivery guide wire 30. The tip 32 may still extend beyond the tip 98 of the dilator 34 to protect the atrial wall from perforation. According to one embodiment, the expanding portion 114 may be expanded as generally illustrated. The dilator 34 may aimed generally towards the mitral valve 61 as generally illustrated in FIG. 16. For example, the tip 98 may be bent or curved by actuating one or more knobs or the like (not shown) to move one or more deflecting wires as discussed herein. The tip 32 of the delivery guide wire 30 may optionally be retracted into the lumen 97 of the dilator 34 to increase the flexibility of the distal tip region 109. The curvature of the dilator 34 may be confirmed using fluoroscopic and/or echo guidance techniques or the like. For example, the contrast media and/or the radiopaque markers may be used.
[0070]Turning now to FIG. 17, with the dilator 34 aimed at the mitral valve 61 and the expanding portion 114 inflated, the distal end region 109 of the dilator 34 may be advanced through the mitral valve 61. It should be understood that the dilator 34 may be advanced through the mitral valve without either the deflectable tip 98 and/or the expandable portion 114; however, the use of one or more of the deflectable tip 98 and/or the expandable portion 114 may reduce the potential of damaging the heart 1 and/or getting entangled within the mitral valve 61. The second segment 97b of the shaft 96 may generally correspond to the location of the bend or curve of the dilator 34 proximate the transseptal puncture site 13. As may be appreciated, the necessary curvature of the dilator 34 between the transseptal puncture site 13 and the left ventricle 3 is relatively sharp.
[0071]The tip 32 of the delivery guide wire 30 may be still located inside the lumen 97 of the dilator 34 back in the left atrium 6 generally where it was located in FIG. 16. The dilator 34 may not yet be aimed or directed at the intended implantation site at this point. Instead, it is only important that the distal end region 109 of the dilator 34 is through the mitral valve 61 without damaging and/or entangling the cusps 66 and the chordae/papillary muscles 68.
[0072]Turning now to FIG. 18, the expandable portion 114 may be retracted/deflated and a steerable catheter 200 may be advanced over the dilator 34 into the left ventricle 3 proximate to the distal end region 109 of the dilator 34. The steerable catheter 200 may define at least one lumen 202 configured receive the dilator 34 as generally illustrated. The lumen 202 may also be configured to receive an implant (not shown) such as, but not limited to, a mitral valve implant as generally disclosed in U.S. patent No. Ser. No. 11/940,724 filed Nov. 15, 2007 and U.S. patent application Ser. No. 12/209,686 filed Sep. 12, 2008, both of which are fully incorporated herein by reference. The steerable catheter 200 may also be configured to be selectively curved or bent to facilitate aiming of the distal tip 204 for securing the implant and/or facilitate removal of the steerable catheter 200.
[0073]One embodiment of a steerable catheter 200a is generally illustrated in FIG. 19. The steerable catheter 200a may include shaft 206 defining at least one lumen 202. The lumen 202 may be configured to receive the dilator 34 and/or an implant (not shown). The shaft 206 may also include a plurality of segments or portions 208a-208n having different hardness or stiffness to produce the desired overall curvature. The shaft 206 may be formed from one or more suitable polymers such as, but not limited to, a polyether block amide. The shaft 206 may have a constant inner and/or outer diameter and may be made from different materials to provide the various stiffness or hardness. Alternatively, or in addition, the shaft 206 may have different inner and/or outer diameters and may be made from one or more materials. For example, the various stiffness or hardness of the shaft 206 may be provided by varying the thickness of the shaft 206 at the different segments or portions. The different hardness of the segments may provide differing degrees of bending stiffness to the steerable catheter 200a which may facilitate advancing the steerable catheter 200a into and/or out of the left ventricle 3 as well as aiming or alignment of the steerable catheter 200a.
[0074]As shown, the steerable catheter 200a may comprise three different segments 208a, 208b and 208n. The first segment 208a may be disposed proximate the distal tip 204. The first segment 208a may optionally include the tapered tip 209 and may have a length of approximately 8 inches. The tapered tip 209 may be provided to facilitate advancing the steerable catheter 200a into the percutaneous puncture site in the groin and over the dilator 34.
[0075]According to at least one embodiment, the first segment 208a may be formed of PEBAX® 2533 having a durometer of 25 D and may have a length of approximately 4 to 6 inches. The second segment 208b may be adjacent to the first segment 208a and may have a length of approximately 2.5 inches. According to at least one embodiment, the second segment 208b may be formed of PEBAX® 4033 having a durometer of 40 D. The third segment 208n may be adjacent to the second segment 208b and may have a length sufficiently long to extend beyond the access incision. According to at least one embodiment, the third segment 208n may be formed of PEBAX® 7233 having a durometer of 72 D.
[0076]It should be understood that the various lengths and hardness described above for the segments 208a-208n may be adjusted or changed depending upon the circumstances of its intended use. For example, patients with larger and/or smaller hearts may require one or more of the segments to be longer or short. An important aspect of the segments 208a-208n is that the softest segment is the first segment 208a. Also, the second segment 208b is disposed approximately 4 to 6 inches from the distal tip 209. As will be explained herein, the length of the first segment 208a may generally correspond to the length between the transseptal puncture site 13 and the implantation site (e.g., the apex) in the left ventricle 3 where the curvature of the steerable catheter 200a may be greatest.
[0077]The steerable catheter 200a may also include a first steering device 210. The first steering device 210 may include a pull ring or the like which may be disposed about 1.5-4 inches from the distal end of the tip 209. The exact length of the first steering device 210 from the tip 209 may depend on the size of the patient's heart which may vary quite a bit depending on, among other things, the degree of regurgitation. For example, patients with functional mitral regurgitation often have dilated cardiomyopathy (enlarged left ventricle). According to at least one embodiment, the first steering device 210 may be located 2 inches from the tip 209.
[0078]The steerable catheter 200a may optionally include at least a second steering device 212. The second steering device 212 may include a pull ring or the like which may be disposed proximate to the distal end of the tip 209. The second or more steering devices 212 may be provided to facilitate curving or bending of the steerable catheter 200a. The first and second steerable devices 210, 212 may be configured to reduce drag during withdrawal and may also facilitate alignment or aiming of the tip 209 within the left ventricle 3. The first and second steerable devices 210, 212 may also facilitate advancement of the steerable catheter 200a over the dilator 34, through the transseptal puncture site 13, and through the left atrium 6 and down into the left ventricle 3.
[0079]The first and/or second steerable devices 210, 212 may be coupled to a handle assembly 214 which may be disposed about a proximal end 216 of the shaft 206. The handle assembly 214 may include one or more fittings and/or valves. For example, the handle assembly 214 may include a valve 215 (for example, but not limited to, a hemostasis valve or the like) and/or a fitting 217 (for example, but not limited to, a luer lock fitting or the like). The handle assembly 214 may also include one or more actuation devices 218a-218n (such as, but not limited to, knobs, sliders, or the like) coupled to the first and second steerable devices 210, 212. The actuation devices 218a-n may be configured to place the first and second steerable devices 210, 212 under tension, therefore causing the shaft 206 to deflect (e.g., curve or bend). For example, the steerable catheter 200b may include actuation devices 218a-n coupled to the first and/or second steerable devices 210, 212 by way of one or more wires or the like 220 disposed along at least a portion of the shaft 206 as generally illustrated in FIGS. 20A-20D.
[0080]By way of example, the actuation devices 218a-n may be slide distally and/or proximally within the handle assembly 214 to increase or decrease the tension placed on the wires 220. The tension in the wires 220 may asymmetrically urge/pull the first and/or second steerable devices 210, 212 (e.g., the first and/or second pull rings) to one side causing the shaft 206 to defect or curve where the wires 220 are coupled to the first and/or second steerable devices 210, 212.
[0081]Turning now specifically to FIGS. 20C-20D, the shaft 206 may optionally include an inner layer 230 configured to provide a substantially seamless inner surface of the lumen 202. The inner layer 230 may also be configured to reduce and/or minimize surface friction. According to at least one embodiment, the inner layer 230 may include PTFE or the like. The shaft 206 may also include another layer 232 configured to provide the desired stiffness. For example, the layer 232 may include Pebax® or the like.
[0082]Optionally, the shaft 206 may include three or more sections configured to provide kink resistance, pushability, and/or flexibility. For example, the shaft 206 may include a reinforced section 234 disposed between the first steering device 210 and the second steering device 212. The reinforced section 234 may be configured to provide increased flexibility, which may facilitate navigating the shaft 206 to the left ventricle 3 and configured to provide increased kink resistance. According to at least one embodiment, the reinforced section 234 may be spiral reinforced and may have a length of 1-3 inches.
[0083]The shaft 206 may also optionally include spiral reinforced section 236 (as generally illustrated in FIGS. 19 and 20C). The spiral reinforced section 236 may extend from the first steering device 210 towards the handle assembly 214 for about 7.5 inches. The spiral reinforced section 236 may be configured to provide kink resistance when deflecting the shaft 206 using the first and/or second steerable devices 210, 212. As may be appreciated, a kink in the shaft 206 may reduce the ability of the user to locate the distal tip 209 within the left ventricle 3 and may also increase the force needed to push the implant through the lumen 202 during deployment.
[0084]The shaft 206 may also optionally include a braided reinforced section 238. The braided reinforced section 238 may extend from the proximal end of the spiral reinforced section 236 to the handle assembly 214. The braided reinforced section 238 may be configured to increase the pushability and torsional strength of the shaft 206 while reducing and/or minimizing kinking. Increasing the pushability and torsional strength and preventing kinking may be important since the length of the shaft 206 from the groin (where the steerable catheter 204 may be introduced) to the left ventricle 3 may be fairly long and involve tortuous anatomy.
[0085]Turning now to FIGS. 21-24, the effects of actuating the first and/or second steerable devices 210, 212 on the shaft 206 are generally illustrated. For example, FIG. 21 generally illustrates one embodiment of a steerable catheter 202a in which the shaft 206 is unbiased. FIG. 22 generally illustrates deflection of the distal region 240. For example, a user may actuate the second actuation device 218n (for example, but not limited to, by sliding the second actuation device 218n generally in the direction of arrow A) causing the second steerable device 212 to deflect the shaft 206 in a region 240 proximate the second steerable device 212. As may be seen, the second steerable device 212 may cause the shaft 206 to deflect and/or bend in a region 240 between the second steerable device 212 and the handle assembly 214. According to at least one embodiment, the second steerable device 212 may generally cause the shaft 206 to deflect and/or bend in a region 240 between the second steerable device 212 and the first steerable device 210. The second steerable device 212 may generally cause the shaft 206 to deflect and/or bend up to approximately 180 degrees, though angles of curvature greater than 180 degrees are also possible depending on flexibility of the shaft 206 as well as the effects of the shaft 206 needing to bend passively to accommodate the patient's anatomy. The radius of the curvature may be 1.0 inches to 2.0 inches, for example, 1.25 inches to 1.75 inches.
[0086]FIG. 23 generally illustrates deflection of the proximal region 242. For example, a user may actuate the first actuation device 218a (for example, but not limited to, by sliding the first actuation device 218a generally in the direction of arrow B) causing the first steerable device 210 to deflect the shaft 206 in a region 242 proximate the first steerable device 210. As may be seen, the first steerable device 210 may cause the shaft 206 to deflect and/or bend in a region 242 between the first steerable device 210 and the handle assembly 214. According to at least one embodiment, the first steerable device 210 may generally cause the shaft 206 to deflect and/or bend up to approximately 180 degrees, though angles of curvature greater than 180 degrees are also possible depending on flexibility of the shaft 206 as well as the effects of the shaft 206 needing to bend passively to accommodate the patient's anatomy. The radius of the curvature may be 1.0 inches to 2.0 inches, for example, 1.25 inches to 1.75 inches.
[0087]Turning now to FIG. 24, one embodiment generally illustrating the deflecting of both the first and second steering actuators 210, 210 is shown. The first and second steerable devices 210, 212 may generally cause the shaft 206 to deflect and/or bend up to approximately 180 degrees, though angles of curvature greater than 180 degrees are also possible depending on flexibility of the shaft 206 as well as the effects of the shaft 206 needing to bend passively to accommodate the patient's anatomy. The radius of the curvature may be 1.0 inches to 2.0 inches, for example, 1.25 inches to 1.75 inches, however, the exact range of the radius may depend upon the location of the first and second steerable devices 210, 212 as well as the flexibility of the regions 240, 242.
[0088]Turning now to FIG. 25, the dilator 34 has been removed from the steerable catheter 200 and the implant (not shown) may be advanced through the lumen 202 proximate to the distal end 219. By actuating the first steerable actuator 210, the user may aim and/or align the distal end segment and/or distal tip 219 of the steerable catheter 200 to the desired location within the left ventricle 3 where it is desired to anchor or secure the implant by deflecting the shaft 206 in the region 242 as generally illustrated by the arrows in FIG. 26 representing the deflection of the steerable catheter 200. Fluoroscopic and/or echo guidance may be used to facilitate aiming of the steerable catheter 200 within the left ventricle 3.
[0089]As may be appreciated, the location of the first steerable actuator 210 and the region 242 along the shaft 206 may generally correspond to the position of the shaft 206 within the left atrium 6 and/or the left ventricle 3 proximate to the mitral valve 61. Ideally, the proximal ring 210 would reside somewhere between the annulus of the valve and the valve leaflets. This would provide for the distal section 234 to be pointed relatively straight at the desired anchor location. The differing lengths of the first section 234 may compensate for the variations in the patients' valve to apex length, although anchoring directly in the apex may not always be the desired location. In FIG. 26 the illustrated bend in the catheter may be closer to the valve.
[0090]Turning now to FIG. 27, once the steerable catheter 200 has been positioned to the desired location within the left ventricle 3 (for example, but not limited to, the apex 36), the implant 110 may be anchored and/or secured to the native tissue. According to one embodiment, the implant 110 may include a shaft 120 coupled to a spacer 122 and an anchoring device 124 as generally illustrated in FIG. 27 and described in U.S. patent No. Ser. No. 11/940,724 filed Nov. 15, 2007 and U.S. patent application Ser. No. 12/209,686 filed Sep. 12, 2008, both of which are fully incorporated herein by reference. However, the implant 110 may include any other device configured to be received within the lumen 202 of the delivery catheter and/or delivered to the heart 1.
[0091]The implant 110 may optionally be advanced through the lumen 202 of steerable catheter 200 using a pusher 280 or the like. Securing the implant 110 to the tissue may depend upon the specifics of the design of the implant 110. For example, the implant 110 may be secured to the tissue using one or more screws (for example, but not limited to, helical screws or the like), tines, and/or sutures (such as, but not limited to, one or more sutures formed, at least in part, of a shape memory alloy).
[0092]Once the implant 110 has been secured to the tissue, the steerable catheter 200 may be removed from the left ventricle 3 and ultimately from the heart 1 and the patient's body. According to one embodiment, the steerable catheter 200 may be removed by urging the steerable catheter 200 proximally (i.e., away from the left ventricle 3). The first steering actuator 210 may be used to minimize the force applied against the implant 110 by the steerable catheter 200 as the implant 110 exits the lumen 202 of the steerable catheter 200. If the force applied to the implant 110 by the steerable catheter 200 as the implant 110 exits the lumen 202 of the steerable catheter 200 is too great, damage may occur to the heart 1 proximate to the implant site and/or the implant 110 may be accidentally pulled out and/or disconnected from the tissue.
[0093]According to one embodiment, the force applied to the implant 110 by the steerable catheter 200 as the implant 110 exits the lumen 202 of the steerable catheter 200 may be further reduced with the aid of the second or more steerable actuators 212. For example, turning to FIGS. 28-30, one embodiment generally illustrating the deflection withdrawal sequence of a steerable catheter 200 having at least a first and a second steerable actuator 210, 212 is shown. FIG. 28 generally illustrates one embodiment of the steerable catheter 200. The implant 110 (not shown) has been secured to the tissue. The second steerable actuator 212 is illustrated in the "straight" position (i.e., the second steerable actuator 212 is not urging the shaft 206 of the steerable catheter 200). The region 240 between the second steerable actuator 212 and the first steerable actuator 210 (for example, but not limited, the distal most 3 inches of the shaft 206) is over the implant 110 from the apex 36 of the left ventricle 3 up to the mitral valve 61. The first steerable actuator 210 is in the bent or curved position to deflect the shaft 206 in order to accommodate the curve or bend from the mitral valve 60, through the transseptal puncture site 13, and into the right atrium 5.
[0094]As the steerable catheter 200 is withdrawn from the left ventricle 3, the region 240 of the steerable catheter 200 may start to encounter the curvature in the left atrium 6 between the mitral valve 61 and the transseptal puncture site 13. In order to accommodate this curvature, the second actuation device 212 may be actuated to deflect the region 240 of the shaft 206 of the steerable catheter 200 as generally illustrated in FIG. 29. Deflecting the region 240 of the shaft 206 may reduce drag of the steerable catheter 200 on the implant 110 and may also reduce the likelihood of dislodging the implant 110 from the tissue. While deflecting the region 240, the user may also un-bend the region 242 of the shaft 206 as the region 242 is moving through the transseptal puncture site 13 and into a region of reduced curvature. As the steerable catheter 200 is further removed, the second actuation device 212 may be un-bent to un-bend the region 240 of the shaft 206 as it moves through the transseptal puncture site 13 as generally illustrated in FIG. 30. At this point, both regions 240, 242 of the shaft 206 may be somewhat curved passively by the anatomy alone.
[0095]Accordingly, the present disclosure may include a steerable catheter including a first steerable actuator disposed 1.5-4 inches from the distal tip of the shaft. The first steerable actuator may include, but is not limited to, a pull ring or the like. The steerable catheter having a first steerable actuator may facilitate aiming or positioning the tip of the steerable catheter to the desired location within the left ventricle. The first steerable actuator may also reduce the force exerted on the implant by the shaft when removing steerable catheter from the left ventricle and may also reduce damage to the heart by allowing the shaft to better conform to the geometries of the pathway.
[0096]The steerable catheter may optionally include at least a second steerable actuator in addition to the first steerable actuator. The second steerable actuator may include, but is not limited to, a pull ring or the like which may be positioned proximate to the distal tip of the shaft. The second steerable actuator may further reduce the force exerted on the implant by the shaft when removing steerable catheter from the left ventricle and may also reduce damage to the heart by allowing the shaft to better conform to the geometries of the pathway. The first and/or second steerable actuators may also facilitate advancing the steerable catheter over a dilator through the tortuous pathway of the transseptal route to the left ventricle.
[0097]The present disclosure may also include a dilator having a plurality of segments having different hardness or stiffness. The different segments may improve the ability of the steerable catheter to be inserted over the dilator through the tortuous pathway of the transseptal route to the left ventricle. According to at least one embodiment, the dilator may include four segments wherein the softest segment is located approximately 6 inches from the distal tip.
[0098]The dilator may optionally include an expandable device (such as, but not limited to, a balloon or the like) disposed proximate the distal tip. The expandable device may facilitate advancing the dilator through the mitral valve without damaging the mitral valve (for example, damaging and/or becoming entangled in the cusps and/or papillary muscles). The dilator may also optionally include a deflectable tip. The deflectable tip may improve the general control of the dilator as it is advanced over a guide wire the transseptal route to the left atrium. The deflectable tip may also allow the expandable device to be aimed towards the mitral valve, further facilitating the advancement to the dilator through the mitral valve.
[0099]An implant consistent with the present disclosure may also comprise other embodiments, for example, but not limited to, one or more of the implants as described in U.S. patent No. application Ser. No.: 11/258,828 filed Oct. 26, 2005 and entitled HEART VALVE IMPLANT; 11/940,724 filed on Nov. 15, 2007 and entitled HEART REGURGITATION METHOD AND APPARATUS; 11/748,121 filed on May 14, 2007 and entitled BALLOON MITRAL SPACER; 11/748,138 filed on May 14, 2007 and entitled SOLID CONSTRUCT MITRAL SPACER; 11/940,674 filed on Nov. 15, 2007 and entitled MITRAL SPACER; 11/748,147 filed on May 14, 2007 and entitled SAFETY FOR MITRAL VALVE PLUG; and 11/940,694 filed on Nov. 15, 2007 and entitled IMPLANT DELIVERY SYSTEM AND METHOD, all of which are fully incorporated herein by reference.
[0100]The steerable catheter and/or dilator disclosed herein may be used to deliver an implant. As described above, a heart valve implant consistent with the present disclosure may be used in the treatment mitral valve regurgitation. However, the heart valve implant as well as its associated methods may also suitably be employed in other applications, e.g., as an implant associated with one of the other valves of the heart, etc. The present disclosure should not, therefore, be construed as being limited to use for reducing and/or preventing regurgitation of the mitral valve.
[0101]As mentioned above, the present disclosure is not intended to be limited to an apparatus, system or method which must satisfy one or more of any stated or implied object or feature of the present disclosure and should not be limited to the preferred, exemplary, or primary embodiment(s) described herein. The foregoing description of the present disclosure has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. Obvious modifications or variations are possible in light of the above teachings. The embodiments were chosen and described to provide the best illustration of the principles of the present disclosure and its practical application to thereby enable one of ordinary skill in the art to utilize the present disclosure in various embodiments and with various modifications as is suited to the particular use contemplated. All such modifications and variations are within the scope of the present disclosure when interpreted in accordance with breadth to which it is fairly, legally and equitably entitled.
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