US20080039743A1 - Methods for determining characteristics of an internal tissue opening - Google Patents

Abstract

A medical system for treating an internal tissue opening can include a closure device and associated delivery device. The closure device can include a multi-cellular body portion operatively associated with a first anchor and a second anchor. The delivery device can include an actuating assembly configured to partially deploy the closure device by a first movement, and deploy a second portion of the closure device by a second movement. The delivery device can also include a release assembly to selectively release or disconnect the closure device from the delivery device. A method of measuring a characteristic of a PFO or verifying placement of the closure device can include positioning the closure device in the PFO and utilizing two or more indicators to determine a characteristic of the PFO, such as tunnel width, or estimating placement of the closure device.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims the benefit of U.S. Provisional Application No. 60/821,947, filed Aug. 9, 2006, U.S. Provisional Application No. 60/821,949, filed Aug. 9, 2006, U.S. Provisional Application No. 60/829,507, filed Oct. 13, 2006, U.S. Provisional Application No. 60/866,047, filed Nov. 15, 2006, and U.S. Provisional Application No. 60/942,625, filed Jun. 7, 2007, the contents of each of which are hereby incorporated by reference in their entirety. This application relates to U.S. patent application Ser. No. ______, filed Aug. 8, 2007, titled DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.1), U.S. patent application Ser. No. ______, filed Aug. 8, 2007, titled DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.2), U.S. patent application Ser. No. ______, filed Aug. 8, 2007, titled DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.3), U.S. patent application Ser. No. ______, filed Aug. 8, 2007, titled SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.4), U.S. patent application Ser. No. ______, filed Aug. 8, 2007, titled SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.5), and U.S. patent application Ser. No. ______, filed Aug. 8, 2007, titled METHODS, SYSTEMS AND DEVICES FOR REDUCING THE SIZE OF AN INTERNAL TISSUE OPENING (Attorney Docket No. 16348.27.7), the contents of each of which are hereby incorporated by reference in their entirety.
BACKGROUND OF THE INVENTION
• 1. The Field of the Invention
• The present invention relates generally to medical devices and methods of use for treating an internal tissue structure. More particularly, the present invention relates to medical devices, systems, and methods for reducing the size of an internal tissue opening.
• 2. The Relevant Technology
• Physical malformations or defects that are present at birth can be detrimental and even lethal when left uncorrected. A PFO is an example of a cardiac birth defect that can be problematic and even result in death when combined with other factors such as blood clots or other congenital heart defects. A PFO occurs when an opening between the upper two chambers of the heart fail to close after birth.
• Some of the problems associated with a PFO can occur when a blood clot travels from the right to the left atria of the heart through the PFO, and lodges in an artery that feeds blood to the brain. A blood clot in the left atrium can be passed through the aorta and travel to the brain or other organs, and cause embolization, stroke, or a heart attack. A PFO can be treated by being closed by a surgical procedure. Additionally, other similar defects (e.g. septal or otherwise) where some tissue needs to be closed in order to function properly can include the general categories of atrial-septal defects (“ASDs”), ventricular-septal defects (“VSD's”) and patent ductus arteriosus (“PDA”), and the like.
• FIGS. 1A-1C depict various views of a heart having a PFO. Theheart10 is shown in a cross-section view inFIG. 1A. In anormal heart10, theright atrium30 receives systemic venous blood from thesuperior vena cava15 and theinferior vena cava25, and then delivers the blood via thetricuspid valve35 to theright ventricle60. However, in the depicted heart10 a septal defect, which is shown as aPFO50, is present betweenright atrium30 andleft atrium40.
• The PFO50 is depicted as an open flap on the septum between the heart'sright atrium30 andleft atrium40. In anormal heart10, theleft atrium40 receives oxygenated blood from the lungs viapulmonary artery75, and then delivers the blood to theleft ventricle80 via themitral valve45. In aheart10 having aPFO50 some systemic venous blood can also pass from theright atrium30 through thePFO50 and mixes with the oxygenated blood inleft atrium40, and then is routed to the body fromleft ventricle80 viaaorta85.
• During fetal development of theheart10, theinterventricular septum70 divides theright ventricle60 andleft ventricle80. In contrast, the atrium is only partially partitioned into right and left chambers during normal fetal development, which results in a foramen ovale fluidly connecting the right and left atrial chambers. As shown inFIG. 1B, when the septum primum52 incompletely fuses with the septum secundum54 of the atrial wall, the result can be atunnel58 depicted as aPFO50.
• FIG. 1C provides a view of the crescent-shaped, overhanging configuration of the septum secundum54 from within theright atrium30 in aheart10 having aPFO50. The septum secundum54 is defined by itsinferior aspect55, corresponding with the solid line inFIG. 1C, and itssuperior aspect53 represented by the phantom line, which is its attachment location to theseptum primum52. The septum secundum54 and septum primum52 blend together at the ends of the septum secundum54. Theanterior end56aandposterior end56pare referred to herein as “merger points” for the septum secundum54 and septum primum52. The length of the overhang of the septum secundum54, which is the distance betweensuperior aspect53 andinferior aspect55, increases towards the center portion of the septum secundum as shown.
• Thetunnel58 between theright atrium30 andleft atrium40 is defined by portions of theseptum primum52 and septum secundum54 between themerger points56aand56pwhich have failed to fuse. Thetunnel58 is often at the apex of the septum secundum54 as shown. When viewed withinright atrium30, the portion of the septum secundum54 to the left oftunnel58, which is referred to herein as theposterior portion57pof the septum secundum, is longer than the portion of the septum secundum54 to the right oftunnel58, which is referred to herein as theanterior portion57aof the septum secundum54. In addition to being typically longer, theposterior portion57palso typically has a more gradual taper than theanterior portion57aas shown. Theanterior pocket59ais the area defined by the overhang of theanterior portion57aof the septum secundum54 and theseptum primum52, and it extends from theanterior merger point56atoward thetunnel58. Similarly, theposterior pocket59pis the area defined by the overhang of theposterior portion57pof septum secundum54 and theseptum primum52, and it extends from theposterior merger point56ptoward thetunnel58.
• Conventional treatments for PFO, and other related conditions have generally involved invasive surgery, which also presents a risks to a patient. Although there are some less invasive treatments for PFO, such treatments have been less efficient at closing the PFO opening than techniques involving invasive surgery.
BRIEF SUMMARY OF THE INVENTION
• The invention relates to a medical system, devices and methods of use for reducing the size of an internal tissue opening, such as a Patent Foramen Ovale (“PFO”). In one embodiment of the invention, the medical system can include a closure device and an associated delivery device. The medical system can be configured to enable a practitioner to selectively position and deploy the closure device in an internal tissue opening to approximate, or in other words bring together the tissue of the opening.
• According to one embodiment of the invention, the closure device can include a multi-cellular body portion operatively associated with a first anchor and a second anchor. The multi-cellular body portion can be configured to enable the closure device to collapse into a relatively narrow non-deployed orientation and expand into a deployed or expanded orientation without plastic deformation or failure of the closure device. The first and second anchors can be configured to engage at least a portion of a wall of the internal tissue opening and/or tissue, such as tunnel tissue, of the opening. In one embodiment of the invention, the closure device can be a non-tubular, substantially flat stent.
• In one embodiment of the invention the closure device can include an ingrowth material to facilitate tissue growth. The closure device can also include one or more indicators to facilitate the estimation of the position and/or orientation of the closure device with respect to the internal tissue opening.
• In accordance with the present invention, the delivery device can include a delivery assembly, an actuating assembly, and a release assembly operatively associated with a handle body. In one embodiment of the invention, the delivery assembly facilitates selective delivery of the closure device from the delivery device, and is operatively associated with the actuating assembly and the release assembly. The actuating assembly interacts with the handle body to selectively deploy the closure device from the delivery assembly. In one embodiment of the invention, the actuating assembly can be configured to deploy at least a portion of the closure device by a first movement and deploy a second portion of the closure device by a second movement. The release assembly can be linked to the handle body to facilitate detachment of the closure device from the delivery device.
• In one embodiment, the closure device is linked to the delivery device by one or more tethers and one or more wires, the tethers being coupled to the handle body and the wires being coupled to a biasing member of the release assembly. The tethers can be configured to receive a portion of the closure device therein to facilitate securement of the closure device to the delivery device. The wires can be detachably coupled to the closure device to enable selective detachment of the closure device from the delivery device by movement of the biasing member.
• These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.
BRIEF DESCRIPTION OF THE DRAWINGS
• To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:
• FIGS. 1A-1C illustrate exemplary views of a heart having a Patent Foramen Ovale;
• FIG. 2 illustrates a perspective view of an embodiment of a medical system according to the present invention;
• FIG. 3A illustrates an embodiment of a closure device according to the present invention;
• FIG. 3B illustrates an embodiment of a closure device in a non-deployed orientation according to the present invention;
• FIG. 3C illustrates a cut-out view of a portion of a closure device according to the present invention;
• FIG. 4 illustrates an embodiment of a delivery device according to the present invention;
• FIGS. 5A-5C illustrate cross-sectional views of a delivery device according to the present invention;
• FIG. 6 illustrates an exploded view of a delivery device according to the present invention;
• FIG. 7 illustrates an embodiment of a coupling system according to the present invention;
• FIG. 8A illustrates an embodiment of a closure device being partially deployed in an internal tissue opening;
• FIG. 8B illustrates an embodiment of a delivery device in an orientation corresponding to the partially deployed closure device ofFIG. 8A;
• FIG. 9 illustrates an embodiment of a partially deployed closure device according to the present invention;
• FIG. 10A illustrates an embodiment of a closure device positioned in an internal tissue opening;
• FIG. 10B illustrates an embodiment of a delivery device in an orientation corresponding to the deployed and detached closure device ofFIG. 10A;
• FIG. 11A illustrates an embodiment of a closure device having an ingrowth material according to the present invention; and
• FIG. 11B illustrates a side view of the closure device ofFIG. 11A.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• The present invention extends to medical systems, methods, and apparatus for reducing the size of an internal tissue opening. By way of explanation, the devices disclosed herein can be used to treat a variety of internal tissue openings, such as a left atrial appendage, paravalvular leaks, PDA's, and VSD's, for example. Although, for purposes of simplicity, frequent reference is made herein to reducing the size of or closing an opening in heart tissue known as Patent Foramen Ovale (“PFO”). Accordingly, it will be understood that references to PFO openings are not limiting of the invention.
• In the following description, numerous specific details are set forth to assist in providing an understanding of the present invention. In other instances, aspects of delivery and/or closure devices, or medical devices in general have not been described in particular detail in order to avoid unnecessarily obscuring the present invention. In addition, it is understood that the drawings are diagrammatic and schematic representations of certain embodiments of the invention, and are not limiting of the present invention, nor are they necessarily drawn to scale.
Introduction ofMedical System100
• FIG. 2 is a perspective view of amedical system100 configured to facilitate closure of an internal tissue opening according to one embodiment of the present invention. In the illustrated embodiment, themedical system100 comprises aclosure device200 adapted to reduce the size of the internal tissue opening, and adelivery device300 adapted to facilitate placement and deployment of theclosure device200 with respect to the internal tissue opening. Themedical system100 of the present invention can provide benefits. For example, themedical system100 can be configured to be used with different sizes, shapes and types of internal tissue openings. Furthermore, themedical system100 can provide various safety measures to increase the safety and effectiveness of positioning theclosure device200. In addition, themedical system100 can be configured to provide distributed lateral force to tissue of the internal tissue opening.
• In the illustrated embodiment,delivery device300 comprises ahandle body302, anactuating assembly320 operatively associated withhandle body302, arelease assembly340 operatively associated with thehandle body302 and adelivery assembly360 operatively associated with theactuating assembly320, therelease assembly340 and thehandle body302. Handlebody302 can be configured to provide a gripping surface for a user. Handlebody302 can be used to positionclosure device200, as well as facilitate deployment of theclosure device200 from thedelivery assembly360.Actuating assembly320 can be moved with respect to handlebody302 to selectively deploy portions of theclosure device200 from thedelivery assembly360, as will be discussed more fully herein below.
• Release assembly340 can be operatively associated with thehandle body302 to enable selective detachment ofclosure device200 from thedelivery assembly360.Delivery assembly360 can houseclosure device200 in a non-deployed or constrained orientation, such as illustrated inFIG. 3B for example, and facilitate deployment ofclosure device200.Delivery assembly360 can include one ormore tethers364 linked to theclosure device200 to facilitate selective detachment of theclosure device200 from thedelivery device300.
Closure Device200
• With reference toFIG. 3A, theclosure device200 is illustrated in a fully deployed, expanded, relaxed or non-constrained orientation. According to one embodiment of the invention, theclosure device200 can be configured to reduce the size of an internal tissue opening so as to close the internal tissue opening. In one embodiment, theclosure device200 can reduce the size of an internal tissue opening by approximating, or in other words bringing together tissue of the internal tissue opening, such as tunnel tissue in a PFO. Theclosure device200 can approximate tissue by applying lateral force to tissue of the internal tissue opening, as will be discussed more fully herein after. Also, theclosure device200 can be configured to enable a user to estimate the position and/or orientation of theclosure device200 with respect to an internal tissue opening, during and after positioning of theclosure device200 in the internal tissue opening.
• According to one embodiment of the invention, theclosure device200 can be a non-tubular stent. Theclosure device200 can be configured to assume a substantially flat configuration, or in other words be configured to be substantially planar, such as illustrated inFIGS. 3A and 11B for example. Furthermore, theclosure device200 can be configured to resist movement out of plane, such asplane260 ofFIG. 11B. However, theclosure device200 may bend out of plane when positioned in a tissue opening.
• Theclosure device200 according to one embodiment of the invention has many advantages. For example, theclosure device200 can be configured to be reliable and compliant. The configuration of theclosure device200 can enable theclosure device200 to be movable between a non-deployed orientation and a deployed orientation without causing failure or plastic deformation of theclosure device200. Theclosure device200 can be used to close various types, shapes and sizes of internal tissue openings. Furthermore, theclosure device200 can accommodate for a range of PFO tunnel lengths, for example. Also, theclosure device200 can be partially or fully deployed from or received back into thedelivery device300.Closure device200 can be configured to substantially conform to the size and shape of a tissue opening. For example, the undulations on the distal and proximal anchors can enable the anchors to substantially, or to a certain degree, conform to the anatomy of a tissue opening.
• Generally, theclosure device200 can have a substantially flat aspect having a length and height greater than its depth or depth thickness. For example, in one embodiment, theclosure device200 has an overall length of 22 mm, a height of 7.5 mm and a depth thickness of 0.4 mm. According to one embodiment of the present invention, when theclosure device200 is in the relaxed or completely expanded orientation, as illustrated inFIG. 3A, the distance between the opposing ends of theproximal anchor218 can be about 22 mm, the distance between the mostproximal attachment member240 of thebody portion202 and the mostdistal indicator220 of thebody portion202 can be about 7.5 mm, and the depth thickness, designated as DT inFIG. 11B, of theclosure device200 can be about 0.4 mm.
• Furthermore, the majority of segments comprising theclosure device200 can have a thickness or width that is substantially less than the depth thickness of the segments. Theclosure device200 can resist out of plane movement due to the size and configuration of the segments. For example, theclosure device200 can be configured to assume a substantially flat configuration in a first plane. The configuration of the segments, for example the segments having a certain depth thickness, can facilitate theclosure device200 resisting movement out of the first plane in a manner similar to an I beam resisting bending in the direction of the web of the beam. The first plane can beplane260 as illustrated inFIG. 11B.
• Also, theclosure device200, according to one embodiment of the invention, can have a unitary construction. For example, theclosure device200 can be cut from a single piece of material, such as cut by a laser, thereby removing the need to assemble or join different segments together. A unitary construction can provide advantages, such as ease of manufacturing and reliability. For example, assembly is not required for a closure device having a unitary construction. Also, a closure device having a unitary construction may not include distinct elements or segments which require joining by joints, thereby reducing a likelihood of failure. Theclosure device200 can be made from a super-elastic material, such as a super-elastic metal or a super-elastic polymer. Furthermore, theclosure device200 can be made from NiTiNol, stainless steel alloys, magnesium alloys, and polymers including bio-resorbable polymers.
• In some embodiments according to the present invention, the closure device can be formed by utilizing a pressurized stream of water, such as a water jet, to remove material from a piece of material to form the closure device. Furthermore, it is contemplated that the closure device can be formed by utilizing one or more of the following: die casting, chemical etching, photolithography, electrical discharge machining, or other manufacturing techniques. It is contemplated that the closure device can be formed through use of a mill or some other type of device adapted to remove material to form a desired shape.
• It will be appreciated by one of ordinary skill in the art in view of the disclosure provided herein that theclosure device200 can comprise multiple segments joined together by a known joining process, such as by an adhesive, by interference fits, crimping, by fasteners, or a weld, or some combination thereof. For example, in one embodiment, the closure device can include multiple segments joined together by various welds to form a closure device according to the present invention. In other embodiments, the segments can be joined together by a plurality of means, such as by the combination of welding, fasteners, and/or adhesives. The segments can be a wire or multiple joined or rolled wires crimped together or joined by a joining process to form theclosure device200.
• In the illustrated embodiment, theclosure device200 includes abody portion202, afirst anchor204 operatively associated with thebody portion202 and asecond anchor206 operatively associated with thebody portion202. Thebody portion202 can be configured to facilitate application of lateral force against tissue of an internal tissue opening. Also, thebody portion202 can be configured to enable theclosure device200 be movable between a non-deployed and deployed orientation. For example, theclosure device200 can be configured to be self-expanding from the constrained or non-deployed orientation, as illustrated inFIG. 3B for example, to the relaxed orientation, as illustrated inFIG. 3A. In other words, theclosure device200 can have a preferential orientation, such that movement of theclosure device200 from a first orientation to a second orientation can create internal stresses in theclosure device200. These internal stresses can serve to bias theclosure device200 to the first orientation. For example, in one embodiment, theclosure device200 can have a preferential orientation of the relaxed or fully deployed orientation as illustrated inFIG. 3A. In this embodiment, movement of theclosure device200 to a constrained orientation, such as illustrated inFIG. 3B for example, can create internal stresses in theclosure device200, thereby creating in the closure device200 a bias to return to the relaxed orientation.
• In the illustrated embodiment,body portion202 includes one or more cells208 defined by a plurality of segments210. Thebody portion202 can include one or more apertures. In one embodiment, an aperture is defined by the cell208, or in other words by the plurality of segments210. In one embodiment, segment210 can be a strut or a body support segment. Cells208 can be distinct, or can be at least partially defined by a common segment. For example,cell208A, as the distal most cell, andcell208C, as the proximal most cell ofbody portion202, are distinct and defined by distinct segments210 with respect to each other. However,cell208B is partially defined by asegment210C which also defines a portion ofcell208A. Similarly,cell208B is partially defined by asegment210G which also partially definescell208C. Likewise,cell208D shares asegment210D withcell208A and shares asegment210H withcell208C.
• Segments210 can be shaped and configured to have a substantially uniform stress at any given point along a certain length, when the segment210 is deflected. For example,segment210A can include afirst portion230 having a width or thickness greater than asecond portion232, wherein the width or thickness decreases from thefirst portion230 to thesecond portion232, or in other words is tapered, in a manner which provides for substantially uniform stress levels along the certain length. In other embodiments, segments can have a substantially constant width along their length.
• FIG. 3C is a cut-out view of a portion of theclosure device200, including thefirst portion230 and thesecond portion232 ofsegment210A. In the illustrated embodiment, the width or thickness of thesegment210A varies along the portion of thesegment210A from the location wheresegment210A extends from theportion254 which joinssegment210A tosegment210C to theintermediate portion234. As theclosure device200 moves between an expanded or otherwise related orientation and a constrained or otherwise collapsed orientation, the segments210 are deflected, with the highest levels of stress in the segment210 being concentrated at the joiningportion254 and decreasing towards theintermediate portion234. The segments210 can be configured in a manner so as to have a substantially equal stress level along the length of the segment210 between the joiningportion254 and theintermediate portion234. The uniform stress level can be accomplished by having the width of the segment210 vary from thefirst portion230 to thesecond portion232 in a calculated manner. In one embodiment, the width of thefirst portion230 of the segment can be about 0.1 mm and the taper to a width of about 0.05 mm at thesecond portion232 of the segment.
• In other embodiments, the uniform stress level can be accomplished by utilizing a gradient of material having varying properties. In other embodiments, the segment210 can have varying widths along its length and comprise a gradient of material sufficient to achieve a substantially uniform stress level between thefirst portion230 and thesecond portion232 of the segment. In the illustrated embodiment, the first portion is adjacent the joiningportion254 and the second portion is adjacent theintermediate portion234. In yet additional embodiments, the joints of the interconnecting segments can include a biasing member, such as a spring, thereby enabling the segments to move relative to each other to collapse or expand theclosure device200. Furthermore, the biasing member of the joint can cause the segments to have a preferential orientation with respect to each other.
• With continued reference toFIG. 3A, segments210 can also be configured to have a rectangular cross-section. In other embodiments, segments210 can have an oval shaped cross section. In yet another embodiment, sections210 can have a round or rounded cross section. Furthermore, in one embodiment, the ratio, or aspect ratio, of the thickness or width to the depth thickness of the first andsecond portions230,232 can range between at least about 1:2 to about 1:20. In one embodiment, the aspect ratio of the width to the depth thickness of thefirst portion230 can be at least 1:2 and the ratio of the width to the depth thickness of thesecond portion232 can be at least 1:4. In an alternative embodiment, the aspect ratio of thefirst portion230 can be about 1:4 and the aspect ratio of thesecond portion232 can be about 1:8. In this manner, theclosure device200 can substantially resist out of plane movement, while allowing in-plane movement during reorientation of various portions of theclosure device200.
• Segments210 can be configured to be compliant. Compliancy of segments210 can enable cells208, and thus thebody portion202, to be oriented in various orientations. For example,body portion202 can be oriented, or in other words moved, between a non-deployed orientation, such as illustrated inFIG. 3B, and a fully deployed orientation, such as illustrated inFIG. 3A. The compliancy of segments210 can facilitate the accommodation by theclosure device200 of a variety of types, shapes and sizes of internal tissue openings. For example, the size and configuration of the first andsecond anchors204,206 and thebody portion202 can enable theclosure device200 to accommodate varying sizes, shapes and types of internal tissue openings. In one implementation, thefirst anchor204 can engage wall tissue of an internal tissue opening and thesecond anchor206 can engage only the tunnel tissue of the internal tissue opening to approximate tissue. In an alternative implementation where the internal tissue opening has a shorter tunnel length, thesecond anchor206 can engage the tunnel tissue and an opposing wall of the internal tissue opening to approximate tissue.
• Segments210 can include anintermediate portion234 configured to facilitate securement of ingrowth materials to theclosure device200, or can be used as anindicator220 to facilitate estimation of the position of theclosure device200 with respect to an internal tissue opening. Furthermore,intermediate portion234 can be configured to facilitate measuring of a characteristic of an internal tissue opening. In one embodiment,intermediate portion234 can include one or more apertures. The apertures can be configured to receive a securing element, such as a thread, therethrough to facilitate securing an ingrowth material to theclosure device200.Intermediate portion234 can be configured to be stiffer or more rigid thanfirst portion230,second portion232, or both. A stifferintermediate portion234 can increase the reliability of segments210.
• In another embodiment, theintermediate portion234 can include anindicator220, such as a dense metallic rivet or concentration of dense material, for use in estimating the orientation and/or position of theclosure device200. Understanding of the orientation and/or position of theclosure device200 can facilitate estimating a physical characteristic of an internal tissue opening and/or the relative position of theclosure device200 with respect to the internal tissue opening. For example, if the distance between theindicators220 is known, a practitioner can estimate a physical characteristic, such as the opening or tunnel width, by determining the new distance between theindicators220 when theclosure device200 is positioned in the tissue opening. Similarly,indicators220 can be positioned on the first andsecond anchors04,206. Theindicators220 can be configured and arranged on theclosure device200 such that when thefirst anchor204 is deployed theindicators220 are substantially aligned. In this manner, a practitioner can estimate whether thefirst anchor204 has fully deployed.
• In some cases, it may be difficult to view theclosure device200 in the event theclosure device200 is at a skewed angle with respect to the viewing plane, such as a fluoroscope. When theclosure device200 is skewed in this manner, it can be difficult to determine accurately the distance of interest. However, when various distances between indicators is known, a user can use the known distances to calculate the distances of interest by using geometry.
• In one embodiment, segments210 along a similar or common lateral plane can have substantially equal lengths. Substantially equal lengths of segments210 in this manner can enablebody portion202 to be moved between the non-deployed and deployed orientation without failure of the segments210. For example, in one embodiment,segments210A and210B have substantially the same length,segments210E,210C,210D, and210K have substantially the same length,segments210F,210G,210H and210L have substantially the same length, andsegments210I and210J have substantially the same length. In this configuration,body portion202 can be collapsed or oriented into the non-deployed orientation, as illustrated inFIG. 3B, without causing damage to thebody portion202 of closure device.
• Theclosure device200 can be configured to have a preferential orientation of the fully deployed orientation as illustrated inFIG. 3A. As theclosure device200 is deployed from thedelivery device300, the configuration ofclosure device200 can cause theclosure device200 to preferentially move toward the fully deployed orientation. Thus, as theclosure device200 is deployed in an internal tissue opening, the preferential orientation of theclosure device200 can cause theclosure device200 to apply lateral force to the tissue of the internal tissue opening. In other words, thebody portion202,first anchor204 and thesecond anchor206 are deflected by an applied force in order to reorient theclosure device200 from the fully deployed orientation to a non-deployed orientation, for example. In this manner, theclosure device200, because of the deflection of thebody portion202,first anchor204 and thesecond anchor206, will have tendency to return to the fully deployed orientation. When theclosure device200 is positioned in an internal tissue opening, the deflectedbody portion202,first anchor204 and thesecond anchor206 can have a tendency to apply a lateral force to tissue of the opening as theclosure device200 attempts to return to the fully deployed orientation.
• Body portion202 can be operatively associated with thefirst anchor204 and thesecond anchor206. First andsecond anchors204,206 can be configured to move between a deployed and non-deployed orientation. First andsecond anchors204,206 can be configured to apply lateral force to tissue of an internal tissue opening, and to engage and/or contact a portion of wall tissue and/or tunnel tissue of an internal tissue opening. In one embodiment, thefirst anchor204 can be a left atrial anchor, and thesecond anchor206 can be a right atrial anchor.
• In the illustrated embodiment, thefirst anchor204 can include afirst anchor segment212 and an opposingsecond anchor segment214. Likewise, thesecond anchor206 can include afirst anchor member216 and an opposingsecond anchor member218. Thefirst anchor segment212 can be configured to move relative to thesecond anchor segment214. Likewise, thefirst anchor member216 can be configured to move relative to thesecond anchor member218. In this manner, theclosure device200 can accommodate for a variety of types, shapes and sizes of internal tissue openings. Thefirst anchor segment212 and thesecond anchor segment214 can be configured to be substantially similar in size, shape and configuration. As such, reference to the configuration and/or function of one of the first or second anchor segments can apply to the other anchor segment. In one embodiment of the invention, thefirst anchor204 and/or thesecond anchor206 can include one or more undulations. The undulations can facilitate reorienting or movement of the anchors with respect to thebody portion202, for example, from a deployed to a non-deployed configuration. Furthermore, the undulations can facilitate the anchor substantially conforming to the anatomy of the tissue opening.
• Thefirst anchor segment212 can include adistal end224 and aproximal end226. Thefirst anchor segment212 can be defined by various segments and can include reinforcedsegments228 and one or moreengaging members222. For example, in the illustrated embodiment, thefirst anchor segment212 is at least partially defined bysegment210K ofcell208D. The engagingmembers222 can be microposts or tines configured to contact and/or engage tissue. The engagingmembers222 can include a sharp tip or can be blunt. The engagingmembers222 can be configured to provide a degree of surface texture in order to increase engagement of thefirst anchor204 with tissue.
• Thefirst anchor segment212 can be configured to be moved between a non-deployed orientation, as illustrated inFIG. 3B, and a fully deployed orientation, as illustrated inFIG. 3A. Thefirst anchor segment212 can be configured such that the distance from theproximal end226 to thedistal end224 of the segment which includes the engagingmembers222 is substantially equal to the distance from theproximal end226 to thedistal end224 of the segment which includes the reinforcedsegments228 andsegment210K. Thesecond anchor segment214 can be configured similar to thefirst anchor segment212.
• First anchor segment212 can be configured to define a closed periphery. For example,first anchor segment212 can include the reinforcedsegment228 extending from thebody portion202 to the segment having the engagingmembers222 which is connected tosegments210K,210L to define a closed periphery withsegment210K. Furthermore, two reinforcedsegments228 can extend from the joiningportion254 of thebody portion202 and join together near thedistal end224 of thefirst anchor204. As such, there are multiple anchor portions extending from thebody portion202. In this manner, anchors of the present invention are reinforced to provide greater rigidity and strength to facilitate stabilization and maintenance of theclosure device200 within a tissue structure.
• First anchor member216 can include adistal end236 and aproximal end238. Thefirst anchor member216 can be defined by various segments and can include one or moreengaging members222. For example, in the illustrated embodiment, thefirst anchor member216 is at least partially defined bysegment210L ofcell208D. The engagingmembers222 can be microposts or tines configured to contact and/or engage tissue. The engagingmembers222 can include a sharp tip or can be blunt. The engagingmembers222 can be configured to provide a degree of surface texture to increase engagement of thesecond anchor206 with tissue.
• It will be understood by one of ordinary skill in the art in view of the disclosure provided herein that the engagingmembers222 can vary in size and shape, and can be positioned at various locations on theclosure device200. In alternative embodiments, one or more engaging members can extend out of plane of the closure device so as to contact tissue which is perpendicular, for example, to the substantially flat plane, such asplane260 ofFIG. 11B, of theclosure device200.
• Thefirst anchor member216 can be configured to be moved between a non-deployed orientation, as illustrated inFIG. 3B, and a fully deployed orientation, as illustrated inFIG. 3A. Thefirst anchor member216 can be configured such that the distance from theproximal end238 to thedistal end236 of the segment which includes the engagingmembers222 is substantially equal to the distance from theproximal end238 to thedistal end236 of the segment which includessegment210L. In this manner,first anchor member216 can be detachably coupled to thedelivery device300 when in a non-deployed orientation inside thedelivery device300 as illustrated inFIG. 3B. Thesecond anchor member218 can be configured similar to thefirst anchor member216.
• Thefirst anchor segment212 can also include afirst portion256 and asecond portion258 configured to facilitate engagement of the internal tissue opening. For example,first anchor segment212 can be configured to include one or more undulations causing thefirst portion256 to be positioned in close proximity withsecond portion258. In this manner, as tissue is positioned between the first andsecond portions256,258, the configuration of thefirst anchor segment212 can engage, or to some degree, pinch the tissue therebetween to facilitate maintenance of the position of theclosure device200 with respect to the tissue opening.
• Theclosure device200 can also includeattachment members240 for use in detachably linking theclosure device200 to thedelivery device300, as will be discussed more fully herein after. Theattachment members240 can include anaperture242 for use in facilitating the linking of theclosure device200 to thedelivery device300.
• FIG. 3B illustrates theclosure device200 in a non-deployed or constrained orientation. The configuration of thebody portion202, and the first andsecond anchors204,206 enables theclosure device200 be reoriented from the fully deployed and preferential orientation, as illustrated inFIG. 3A, to the non-deployed or collapsed orientation as illustrated. In the collapsed or non-deployed orientation, thefirst anchor204 extends distally and thesecond anchor206 extends proximally, with theattachment members240 being the proximal most portions of thesecond anchor206 and thebody portion202.
• In the illustrated embodiment, theclosure device200 is positioned inside of adelivery portion366 of thedelivery device300. The configuration of theclosure device200 can cause portions of the closure device to apply force to the wall of thedelivery portion366 due to the preferential orientation of theclosure device200. Theclosure device200 is configured to be received into and deployable from thedelivery portion366.
Delivery Device300
• FIG. 4 illustrates one embodiment of thedelivery device300. In the illustrated embodiment, thedelivery assembly360 includes acatheter362 having adelivery portion366, and a plurality oftethers364 at least partially housed by thecatheter362. Thetethers364 can be configured to facilitate selective detachment of theclosure device200 from thedelivery device300. Thedelivery portion366 can be configured to receive theclosure device200 therein. Thecatheter362 can be coupled to theactuating assembly320, such that movement of theactuating assembly320 can cause movement of thecatheter362.
• In the illustrated embodiment, theactuating assembly320 includes afirst member322 operatively associated with thehandle body302, asecond member324 operatively associated with thefirst member322 and thehandle body302, and aknob338 linked to thefirst member322. Theactuating assembly320 can be utilized by a user to selectively deploy theclosure device200 from thecatheter362.
• Thehandle body302 can includeindicia304 to enable a user to estimate the degree of deployment of theclosure device200 from thedelivery device300, as well as predict detachment of theclosure device200 from thedelivery device300. For example,indicia304 can include deployment indicia306 and release indicia308. Deployment indicia306 can be utilized to enable a user to estimate the degree of deployment of theclosure device200 from thecatheter362, and the release indicia308 can be utilized to predict the detachment of theclosure device200 from thedelivery device300. Thehandle body302 can also include arelease pin groove310. Therelease pin groove310 can be operatively associated with therelease assembly340 to facilitate the selective detachment of theclosure device200 from thetethers364.
• According to one embodiment of the invention, therelease assembly340 can include a biasingmember342 operatively associated with thehandle body302 to facilitate detachment of theclosure device200. Arelease knob346 can be provided to manipulate the position of biasingmember342 in order to release or detach theclosure device200. In one embodiment, therelease knob346 is coupled to the biasingmember342, such that movement of therelease knob346 can cause movement of the biasingmember342. The biasingmember342 can include arelease pin344 configured to be received in, influenced by and movable in therelease pin groove310. In this manner,release pin groove310 can restrict, and thereby influence the movement of the biasingmember342 with respect to thehandle body302.
• The biasingmember342 is configured to interact with thehandle body302 such that when therelease pin344 is positioned in a terminating portion of therelease pin groove310, as illustrated inFIG. 4, the biasingmember342 is biased in the proximal direction with respect to thehandle body302. In this manner, therelease pin344 can be moved from the terminating portion of therelease pin groove310, as illustrated inFIG. 4, to the opposing terminating portion of therelease pin groove310 adjacent the release indicia308B by applying force to the biasingmember342 through therelease knob346 in the distal direction, rotating therelease knob346 and then moving therelease knob346 in the proximal direction to release theclosure device200, as illustrated inFIG. 10B.
• FIG. 5A is a cross-sectional view of the distal end of thecatheter362. In the illustrated embodiment, thecatheter362 includes adelivery portion366 for use in positioning thecatheter362. Thecatheter362 can be made from a resilient material having sufficient axial stiffness to allow a practitioner to position thecatheter362 with respect to an internal tissue opening, and sufficient rotational stiffness to allow a practitioner to rotate thecatheter362 by rotating thehandle body302.
• In one embodiment, thecatheter362 comprises a braided polyimide. In other embodiments, thecatheter362 can be made from a material having a sufficient axial stiffness, such as a braid reinforced polymer, axially reinforced polymer, metal reinforced polymer, carbon reinforced polymer, or some other type of axially stiff material. Thedelivery portion366 can be made from a thermoplastic elastomer, such as PEBAX®. In other embodiments, the delivery portion ortip portion366 can be made from a material having sufficient flexible properties, such as a polymeric material. In other embodiments, thedelivery portion366 can include a combination of materials, such as metallic materials and polymeric materials.
• Thedelivery portion366 can define alumen368 to facilitate placement of thecatheter362. For example, a guidewire can be received in thelumen368 to guide thecatheter362 to a desired location. In this manner, theclosure device200 can be located proximate to the internal tissue opening in a quick and efficient manner. Furthermore, thedelivery portion366 can be shaped, such as including a bend, in order to facilitate placement of thedelivery portion366 through a PFO, for example. In one embodiment of the invention, thecatheter362 can be considered a rapid exchange catheter wherein the delivery ortip portion366 enables a guidewire to be linked to thecatheter362 in a quick and efficient manner for placement of thecatheter362.
• Thecatheter362 anddelivery portion366 can be configured to at least partially housetethers364 in a lumen which is distinct and separate fromlumen368. For example,lumen368 can be in a spaced apart, non-coaxial arrangement from the lumen which houses tethers364, such that a guidewire can be received throughlumen368 without being introduced into the lumen or space in which thetethers364 are housed. In this manner, a user can introduce a guidewire into thelumen368 at the distal end of thecatheter362, rather than the lumen which at least partially houses thetethers364 which would require the guidewire to be introduced into the lumen at the proximal end of thecatheter362. In alternative embodiments, thelumen368 configured to receive the guidewire therein can be positioned inside the lumen which houses thetethers364. In this embodiment,lumen368 would include an opening and an exit at the distal end of thecatheter362 in order to facilitate the quick placement of a guidewire through thelumen368.
• In one embodiment,catheter362 can include a rounded cross-section and thedelivery portion366 can include a rectangular cross-section. The rectangular cross-section of thedelivery portion366 can facilitate proper deployment of theclosure device200 from thedelivery device300, as well as facilitate theclosure device200 being reintroduced back into thedelivery portion366. The rectangular cross-section of thedelivery portion366 can be sized to orient thetethers364 next to each other in a linear fashion. In this manner, the likelihood that thetethers364 cross each other upon reintroduction of theclosure device200 into thedelivery portion366 can be reduced.
• In one embodiment of the invention, tethers364 includes three tethers364A-C, eachtether364 being sized and configured to attach to and/or accommodate therein anattachment member240 of theclosure device200. One example of a tether is a line or hollow tube coupled to thehandle body302. Thetether364 can comprise a flexible, hollow shaft having sufficient stiffness such that as actuatingassembly320 moves thecatheter362 proximally with respect to thehandle body302, theclosure device200 is forced out of thedelivery portion366. Likewise, thetether364 can be configured to pull theclosure device200 back into thedelivery portion366 as theactuating assembly320 is moved distally with respect to thehandle body302.
• In one embodiment, thetether364 can be a coil of stainless steel covered by a heatshrunk tubing to give the coil a degree of tensile strength and rigidity. In an alternative embodiment, thetether364 can be a polymeric tube. In yet an additional embodiment, thetether364 can be a combination of polymeric materials and metallic materials. In some embodiments, an additional heatshrunk tubing covers a proximal segment of the three tethers364A-C. The heatshrunk covering can increase the column strength of thetether364, which can enable thetethers364 to assist with deployment and reintroduction of theclosure device200 from and into thedelivery portion366. Thetethers364 can have a distal tip configured to correspond to the shape and size of theattachment members240 of the closure device, such that theattachment member240 can be received into the distal tip of thetether364, as illustrated inFIG. 7.
• Tethers364 can be made from a material having sufficient flexibility to substantially prevent distortion or otherwise influence the orientation of theclosure device200 when the closure device is deployed from thecatheter362, yet have sufficient axial strength to facilitate deployment of theclosure device200 when thecatheter362 is moved proximally with respect to theclosure device200. Thetethers364 can have a lumen extending therethrough of sufficient size and configuration to enable a plurality ofwires378 to be housed and movable therein.
• FIGS. 5B-5C are cross-sectional views illustrating thedelivery assembly360 in association with theactuating assembly320. However, for simplicity,FIG. 5B does not include the biasingmember342 and associatedrelease knob346, andFIG. 5C illustrates details about the interaction between thedelivery assembly360 and theactuating assembly320 without illustrating thefirst member322 and details about thehandle body302 and thesecond member324. In the illustrated embodiment, the proximal end of thecatheter362 is coupled to the distal end of thesecond member324. In this manner, movement of thesecond member324 can cause a corresponding movement in thecatheter362. For example, as thesecond member324 moves proximally with respect to thehandle body302, so also does thecatheter362 move proximally with respect to thehandle body302.
• According to one embodiment of the invention, thetethers364 can extend from thedelivery portion366, through thecatheter362 and thesecond member324 and are coupled to thehandle body302. Thetethers364 can be coupled to thehandle body302 by, for example, anintermediate member376. Thetethers364 can be covered with a first andsecond housing370,372 to provide a degree of rigidity to the portions of thetethers364 located inside of thehandle body302 and thesecond member324. For example, in one embodiment, thefirst housing370 comprises a rigid, hollow, metal rod configured to house the three tethers364A-C therein. Thefirst housing370 can extend from theintermediate member376, which facilitates securement of thetethers364 to thehandle body302, and terminate at some point beyond thehandle body302.
• In the illustrated embodiment, thesecond housing372 can extend from the distal end of thefirst housing370 and extend into thecatheter362. Thesecond housing372 can comprise a resilient material configured to resist axial stretching while allowing a degree of bending. In one embodiment, thesecond housing372 comprises a coil of metal, such as stainless steel, configured to resist axial stretching, yet allow a degree of bending. Thesecond housing372 can allow a practitioner to bend a portion of thecatheter362, if needed, in order to manipulatedelivery device300 for placement of theclosure device200. Aseal374 can be provided between thefirst housing372 and thesecond member324 in order to reduce or substantially prevent bodily fluid, which may have entered thecatheter362, from entering thehandle body302 or otherwise inappropriately being expelled from thedelivery device300.
• In the illustrated embodiment, thesecond member324 can comprise an elongate shaft defining anaxial lumen348 and alumen350 in fluid communication therewith.Lumen350 can be configured to couple to a medical device for removal of fluid from thedelivery device300. Theaxial lumen348 can be sized to accommodate and allow movement of thetethers362, thefirst housing370 and thesecond housing372 therein. Thesecond member324 can include aguide326. Theguide326 can be configured to cooperate with afirst pin352 and asecond pin354 to influence movement of thesecond member324 with respect to thehandle body302, as will be discussed more fully herein below.
• In the illustrated embodiment, thefirst member322 comprises a hollow elongate tube sized and configured to enable thesecond member324 to be received into and moveable within thefirst member322. Thefirst member322 can be operatively associated with thehandle body302 and thesecond member324 to facilitate deployment of theclosure device200. For example, thefirst member322 is linked to thehandle body302 by athird pin356. Thethird pin356 is received in aguide358 of thefirst member322. Theguide358 is configured to interact with thethird pin356 in order to influence the movement of thefirst member322 with respect to thehandle body302.
• Thefirst pin352 can link thefirst member322 to thesecond member324. When thefirst pin352 links thefirst member322 to thesecond member324, thesecond pin354 links thehandle body302 to thesecond member324, and thethird pin356 links thehandle body302 to thesecond member322, movement of thefirst member322 can selectively deploy theclosure device200 from thedelivery portion366.
• With reference to FIGS.5A-C and6, the association between thefirst member322, thesecond member324, thehandle body302 and the biasingmember342 will be discussed.FIG. 6 is an exploded view of theactuating assembly320 and therelease assembly340. In the illustrated embodiment, thesecond member324 is received into thefirst member322, and thefirst member322 is received into theknob338 and thehandle body302, as illustrated inFIGS. 4 and 5B-5C.
• According to one embodiment of the invention, thesecond member324 can include aguide326 having a first portion326aand a second portion326b, which guide326 can be defined by a slot formed on the outer surface of thesecond member324. In the illustrated embodiment, the first portion326ais straight and extends along at least a portion of the length of thefirst member324 and joins with the second portion326bof theguide326. The second portion326bcan include a helical groove or slot that begins with and is contiguous with the first portion326aand extends distally therefrom.
• Theguide326 of thesecond member324 is configured to interact with thehandle body302 and thefirst member322 to selectively retract thecatheter362 in order to deploy theclosure device200. For example, the first portion326aof theguide326 is configured to interact with thesecond pin354, which is secured into thehandle body302 by means of threads and extend into the first portion326aof theguide326. In this manner, thesecond member324 can move laterally with respect to thehandle body302. Thus, rotation of thehandle body302 can translate to rotation of thesecond member324, and thus, thecatheter362 and thedelivery portion366.
• The second portion326bof theguide326 is configured to interact with thefirst pin352, which is secured to thefirst member322 by means of threads and extends into the second portion326bof theguide326. In this manner, as thefirst member322 is rotated, thefirst pin352 will interact with the second portion326bto move thesecond member324 in the proximal direction. As thesecond member324 is moved in the proximal direction with respect to thehandle body302, thecatheter362 moves proximally with respect to thehandle body302 thereby exposing or deploying theclosure device200 from thedelivery portion366.
• In the illustrated embodiment, thefirst member322 can include aguide358 defined by a slot or groove formed in the outer surface of thefirst member322. In the illustrated embodiment, theguide358 can include a first portion358aconnected to a second portion358b. The first portion358aofguide358 can be straight and extend along at least a portion of the length of thefirst member322, and then join and be contiguous with the second portion358b. The second portion358bof theguide358 can be a helical groove that wraps around at least a portion of the outer surface of thefirst member322 and extends along at least a portion of the length of thefirst member322.
• As described previously, thethird pin356, which is secured to thehandle body302 by means of threads, can extend into theguide358 in order to influence movement of thefirst member322 with respect to thehandle body302. For example, as thethird pin356 is positioned in the most proximal portion of the first portion358a, theclosure device200 is completely received into and enclosed by thedelivery portion366. As thefirst member322 is moved in the proximal direction as illustrated by the arrow inFIG. 4, thethird pin356 moves in the first portion358aof theguide358 to deploy thefirst anchor204 of theclosure device200 from thedelivery portion366.
• The length of the first portion358acan correspond with the distance that thefirst member322, and thus thecatheter362, must move in order to deploy thefirst anchor204 of theclosure device200 from thedelivery portion366. For example, a practitioner can move theknob338, which is coupled to thefirst member322, in the proximal direction. Movement of theknob338 in the proximal direction can cause thethird pin356 to move linearly in the first portion358aof theguide358. In this manner, thesecond member324 can move correspondingly with thefirst member322 because of thefirst pin352, which links thefirst member322 to thesecond member324. As thethird pin356 is positioned in the location of theguide358 where the first portion358ameets with the second portion358b, thefirst member322 can be rotated in order to selectively deploy the remaining portions of theclosure device200 from thedelivery portion366 of thedelivery device300.
• As thefirst member322 is rotated, thethird pin356 is positioned in the second portion358bto influence movement of thefirst member322 with respect to thehandle body302, and thefirst pin352, which is coupled to thefirst member322, interacts with the second portion326bof theguide326 to move thesecond member324 in the proximal direction with respect to thehandle body302. Movement of thesecond member324 in the proximal direction in this manner can cause further deployment of theclosure device200 from thedelivery portion366. As will be appreciated, theknob338 can be coupled to thefirst member322 to facilitate and enable movement of thefirst member322 with respect to thehandle body302.
• The dual movement required to deploy theclosure device200 can provide some efficiency and safety advantages. For example, a practitioner can move theknob338 in a first direction (i.e., proximally in a linear fashion) to deploy thefirst anchor204 from thedelivery portion366. Thereafter, the practitioner can move thehandle body302 to position thefirst anchor204 against the wall tissue of an internal tissue opening, such as against the left atrial wall of a heart, for example. Once thefirst anchor204 is positioned against the wall, the practitioner can move theknob338 in a second direction (i.e., rotate the knob) to further deploy theclosure device200 from thedelivery portion366. The dual movement enables a user to predict the deployment of theclosure device200 to reduce the risk of premature deployment of the closure device.
• It will be understood by one of ordinary skill in the art in view of the disclosure provided herein that other means of controlling movement of one member with respect to the other, such as the first member with respect to the second member, can be utilized without departing from the scope and spirit of the invention. For example, a structure configured to substantially restrict or control movement of the first element with respect to the second element and/or handle body can be utilized. In one embodiment, the structure can include a cam and a follower. In an alternative embodiment, the structure can include a slider.
• Therelease assembly340 can be configured to be received in the proximal end of thehandle body302. Therelease assembly340 can be configured to provide additional safety features for the practitioner and patient by reducing the risk of premature detachment of theclosure device200 before it is positioned appropriately in an internal tissue opening. For example, a practitioner using themedical system100 of the present invention can manipulate theactuating assembly320 to deploy theclosure device200 for positioning in an internal tissue opening. In order to deploy a first portion of theclosure device200, a user can move theknob338, and thus thefirst member322, in the proximal direction with a first movement, which is a linear movement, then deploy the remaining portions of theclosure device200 by a rotational movement. Once theclosure device200 is deployed, the practitioner can be required to move their hands in order to utilize therelease assembly340 to release theclosure device200 from thedelivery device300.
• In the illustrated embodiment therelease assembly340 can include arelease knob346 coupled to a biasingmember342, which is received into the proximal end of thehandle body302. The biasingmember342 can be configured to include a plurality ofslots318 configured and arranged to act similar to a spring. Theslots318 can be configured and arranged in the biasingmember342 to enable at least a portion of the biasingmember342 to be compressed. Compression of the biasingmember342 can cause therelease pin344 to move toward the distal end of the biasingmember342.
• The biasingmember342 can be configured such that when biasingmember342 is positioned in thehandle body302, the biasingmember342 naturally tends to maintain its position with therelease pin344 in therelease pin groove310 as illustrated inFIG. 4. As force is applied to therelease knob346 in the distal direction (i.e., compress the biasing member342), therelease pin344 can be moved out of a terminating portion of therelease pin groove310 and rotated and moved into a proximal terminating portion of therelease pin groove310 to release theclosure device200 from thedelivery device300.
• Theclosure device200 is released from thedelivery device300 by moving a plurality ofwires378 which are housed by atether364 and coupled to the biasingmember342. Illustrated inFIG. 7 is a cross-sectional view ofattachment member240 of theclosure device200 received into atether364 and coupled by first and second wires378a,378b. In the illustrated embodiment, a second wire378bcan extend through and out of thetether364 and form a loop. The loop can extend through anaperture242 of theattachment member240 of theclosure device200. With the loop of second wire378bpositioned through theaperture242 of theattachment member240, a first wire378a, which extends through and out of thetether364, can extend through the loop of the second wire378bto form a locking feature. When the first wire378aextends sufficiently through the loop of the second wire378b, theclosure device200 can remain coupled to thedelivery device300 until the first wire378ais pulled through the loop of the second wire378b, and the second wire378bis pulled out of theaperture242 of theattachment member240.
• The first wire378aand the second wire378bcan be attached at their proximal ends to the biasingmember342. In this manner, movement of the biasingmember342 in the proximal direction can cause movement of thewires378 also in the proximal direction. In one embodiment, thewires378 can be coupled to the biasingmember342 such that movement of the biasingmember342 will cause the first wire378ato move a distance sufficient to be removed from the loop of second wire378bbefore the second wire378bis moved by the biasingmember342. Thewire378 can comprise a metallic wire, such as a NiTiNol wire. Thewire378 can also include a stainless steel wire or some other type of metal or stiff polymer. Thewires378 can be made from a material having a sufficient tensile strength to secure theclosure device200 to thetethers364 without causing thewires378 to fail or substantially deform. In one embodiment of the invention, thewire378B can include a stainless steal wire andwire378A can include a NiTiNol wire.
• Other types and configurations of biasing members can be utilized without departing from the scope and spirit of the invention. For example, in one embodiment, the release assembly can include a rotating member coupled to the securing elements. In this embodiment, rotation of the rotating member can cause the securing elements to wind around the rotating member thereby causing the distal ends of the securing elements to move proximally with respect to the handle body.
• The method of use of themedical system100 will now be described with reference to a particular internal tissue opening, namely a PFO.FIG. 8aillustrates the positioning of thecatheter362 through thetunnel58 of a PFO with thefirst anchor204 of theclosure device200 deployed. Themedical system100 is utilized to close an internal tissue opening by positioning thecatheter362 through an internal tissue opening and moving thefirst member322 by a first movement (i.e., linearly) in the proximal direction to deploy thefirst anchor204 of theclosure device200. After thefirst anchor204 of theclosure device200 is deployed, thedelivery device300 can be moved in the proximal direction in order to seat thefirst anchor204 against the wall of the tissue opening or otherwise engage the wall of the internal tissue opening, as illustrated inFIG. 9. This can be done by moving thehandle body302 in the proximal direction.
• After thefirst anchor204 has been positioned against the wall of the internal tissue opening, theknob338, and thus thefirst member322, can moved by a second movement, or in other words, rotated to deploy additional portions of theclosure device200 as illustrated inFIG. 9. After theclosure device200 has been fully deployed and conforms to the anatomy of the internal tissue opening, therelease assembly340 can be actuated to selectively detach thedelivery device300 from theclosure device200 as illustrated inFIGS. 10aand10b.
• Therelease assembly340 can be actuated by moving the biasingmember342 distally with respect to thehandle body302, then rotating the biasing member with respect to thehandle body302, and then moved proximally with respect to thehandle body302. In this manner,closure device200 substantially conforms to the anatomy of the internal tissue opening. As noted previously, the configuration of theclosure device200 is such that when positioned in the internal tissue opening as illustrated, the members of theclosure device200 apply lateral force to the tissue of the internal tissue opening, such as thetunnel58 of the PFO, to approximate tissue of the PFO for closure.
• FIG. 11A illustrates one embodiment of aclosure device200 that can include amember250, such as an ingrowth material. Themember250 can be configured to induce tissue growth. Themember250 can be fixed to theclosure device200 by means of a securing element, such as athread252. For example, thethread252 can extend through themember250 and through the apertures in theintermediate portions234 in order to secure themember250 to theclosure device200. In other embodiments, themember250 can be secured to theclosure device220 by a known securing means, such as by an adhesive, a heat weld, or some other known or hereafter developed means for securement.
• Themember250 and thethread252 can include a bio-resorbable material, such as polylactide or polyglycolide or collagen. Themember250 can be sized and configured to enable theclosure device200 to be deployed from and received into thedelivery portion366 of thedelivery device300. Furthermore, themember250 can be configured to interact with tissue of the internal tissue opening to stimulate growth of tissue for closure of the internal tissue opening. For example, themember250 can interact with thetunnel tissue58 of a PFO in order to stimulate growth of tissue in thePFO tunnel58.
• Themember250 can be any suitable material which can or tends to promote tissue growth. Examples of such material can include a polymeric material, or a woven material, such as a woven metallic or biological material. In one embodiment, themember250 can be a piece of foam. In alternative embodiments, themember250 can be a piece of yarn, fabric or string, or some combination thereof. Other tissue growth promoting members can include a coating disposed on theclosure device200. In other embodiments, themember250 can be a piece of foam, braided material such as a piece of yarn or string, or fabric which has a coating disposed thereon.
• Themember250 can include materials such as a piece of polyurethane or some other biocompatible polymer, including bio-resorbable polymers. Themember250 can also include Dacron or polymeric threaded material which have been woven or knitted, or formed into compressed, non-woven fabrics. Themember250 can also include a metallic material, such as a NiTiNol, stainless steal or some other biocompatible alloy or bio-resorbable metal, such as magnesium alloy, or some combination thereof. In one embodiment, themember250 comprises a metallic wire.
• FIG. 11B illustrates a side view of theclosure device200, and illustrates one example of the closure device having a substantially flat configuration. In the illustrated embodiment, theclosure device200 can include a depth or depth thickness designated as DT, and aplane260 extending perpendicular into and out of the plane of the page. In this embodiment, themember250 can extend beyond at least afirst edge262 of theclosure device200. Furthermore, themember250 can extend beyond both thefirst edge262 and asecond edge264 of theclosure device200. In this manner,member250 can contact tissue adjacent theclosure device200 to promote tissue growth in the tissue opening.
• Themember250 can be sized and configured to extend beyond at least thefirst edge262 of the closure device200 a sufficient distance to contact tissue of the tissue opening. In one embodiment, themember250 can extend beyond at least the first edge262 a sufficient distance to contact tissue adjacent thefirst edge262, thereby causing the end of themember250 which is in contact with the tissue to deflect or bend. In this manner, more surface area of themember250 can be in contact with tissue to thereby facilitate an increase in tissue growth. In other embodiments, themember250 can extend beyond both thefirst edge262 and the second edge264 a sufficient distance to cause both ends of themember250 to bend, which can result in more surface area contacting the tissue. In one embodiment, themember250 can extend between at least 0.5 mm and 5 mm beyond thefirst edge262. In another embodiment, themember250 can extend between at least 0.5 mm and 5 mm beyond thefirst edge262, and can extend between at least 0.5 mm and 5 mm beyond thesecond edge264. Furthermore, themember250 can have a thickness of between at least 0.25 mm and 2 mm.
• In addition, in some embodiments themember250 can be configured to decrease the size of a remaining void in the tissue opening after theclosure device200 has been positioned in the tissue opening.Member250 extending beyond thefirst edge262 of theclosure device200 is an example of themember250 extending substantially out of plane of the substantially flat configuration.
• The present invention can also include the following methods, systems and devices.
• A medical device comprising: a body portion comprising two or more cells, said body portion being movable between a deployed and non-deployed orientation; and at least one anchor linked to said body portion, said at least one anchor being adapted to reduce proximal movement of the medical device when the medical device is positioned in an internal tissue opening.
• A medical device comprising: a multi-cellular structure adapted to selectively expand and contract between a deployed and non-deployed orientation; a first anchor operatively associated with said multi-cellular structure, said first anchor being adapted to selectively engage at least a portion of a wall of an internal tissue opening; and a second anchor operatively associated with said multi-cellular structure, said second anchor being adapted to engage at least a portion of at least another portion of the wall of the tissue opening.
• A method for closing a Patent Foramen Ovale, comprising the steps of: positioning at least a portion of a medical device into a left atrium of a heart, said medical device comprising a first anchor, a multi-cellular structure linked to said first anchor, and a second anchor linked to said multi-cellular structure, said first anchor, said multi-cellular structure and said second anchor being adapted to selectively move between a non-deployed and deployed orientation; locating at least a portion of said first anchor against at least a portion of a left atrial wall of the heart; and locating at least a portion of said second anchor against at least a portion of at least one of a tunnel of the Patent Foramen Ovale or a right atrial wall of the heart.
• A medical device for approximating tissue of an internal tissue opening together, the medical device comprising: a body portion comprising two or more cells, said body portion being adapted to apply lateral force to tissue of an internal tissue opening; and at least one anchor operatively associated with said body portion.
• A medical device for approximating tissue of an internal tissue opening together, the medical device comprising: a multi-cellular structure adapted to selectively expand and contract between a deployed and non-deployed orientation, said multi-cellular structure configured to preferentially expand; and at least one anchor operatively associated with said multi-cellular structure, said at least one anchor being adapted to move between a deployed and non-deployed orientation, at least a portion of said at least one anchor being adapted to apply lateral force to at least a portion of tissue of an internal tissue opening when said first anchor is deployed.
• A method for reducing the size of an internal tissue opening, comprising the steps of: positioning at least a portion of a medical device through an internal tissue opening, said medical device comprising a multi-cellular structure and at least a first anchor associated with said multi-cellular structure, said at least one anchor and said multi-cellular structure being adapted to selectively move between a non-deployed and deployed orientation; and applying lateral force to tissue of the internal tissue opening by at least partially deploying said at least one anchor.
• A medical device comprising: two or more cells forming a body portion, said body portion being adapted to move between a collapsed and expanded orientation to apply lateral force to tissue of an internal tissue opening; and at least one anchor linked to said body portion, said at least one anchor being adapted to extend distally when said at least one anchor is collapsed and extend laterally when said at least one anchor is moved from a collapsed to an expanded orientation.
• A method for deploying a closure device, the method comprising the steps of deploying a left anchor of a closure device from a delivery device, said delivery device comprising an actuating assembly operatively associated with a handle body, said left anchor being adapted to deploy by linearly moving at least a portion of said actuating assembly with respect to said handle body; and deploying a second anchor of said closure device from said delivery device by rotating at least a portion of said actuating assembly with respect to said handle body.
• A delivery device for an internal tissue opening closure device, the delivery device comprising: a handle body including first and second guide members; a first member operatively associated with said handle body, at least a portion of said first member defining a guide, said first guide member cooperating with said guide to influence movement of said first member with respect to said handle body, said first member including a guide structure; and a second member operatively associated with said first member, at least a portion of said second member defining a second guide, said guide structure cooperating with said second guide to influence the movement of said second member with respect to said first member, and said second guide member cooperating with said second guide to influence the movement of said second member with respect to said handle body.
• A delivery device for an internal tissue opening closure device, the delivery device comprising: a handle body; a first pin coupled to said handle body; a second pin coupled to said handle body; a first cam adapted to be at least partially received into and movable with respect to at least a portion of said handle body, said first cam including a slot formed on an external surface of said first cam, said slot including a first portion and a second portion, said first portion of said slot extending along at least a portion of the length of said first cam, said second portion of said slot extending at least partially around said first cam, said first pin received in said slot; a third pin coupled to said first cam; and a second cam adapted to be at least partially received into and movable with respect to at least a portion of said first cam, said second cam including a first and second slot formed on an external surface of said second cam, said first slot of said second cam extending at least partially around said second cam and said second slot of said second cam extending along at least a portion of the length of said second cam, said third pin received in said first slot of said second cam and said second pin received in said second slot of said second cam.
• A medical device for closing an internal tissue opening, the medical device comprising: a multi-cellular structure configured to assume a substantially flat configuration; at least one anchor operatively associated with said multi-cellular structure, said at least one anchor comprising a plurality of segments at least partially defining a closed periphery.
• A medical device for closing an internal tissue opening, the medical device comprising: a multi-cellular structure adapted to be moveable between a first orientation and a second orientation; at least one anchor operably associated with said multi-cellular structure; and a tissue growth member associated with said multi-cellular structure, said tissue growth member being adapted to enhance tissue growth in the internal tissue opening.
• The present invention may be embodied in other specific forms without departing from its spirit or essential characteristics. The described embodiments are to be considered in all respects only as illustrative and not restrictive. The scope of the invention is, therefore, indicated by the appended claims rather than by the foregoing description. All changes which come within the meaning and range of equivalency of the claims are to be embraced within their scope.

Claims (20)

1. A method for measuring characteristics of a tissue structure, comprising the steps of:

positioning at least a portion of a medical device in the tissue structure, said medical device comprising a multi-cellular structure, at least one anchor linked to said multi-cellular structure, and two or more indicators; and

measuring a physical characteristic of the tissue structure utilizing said two or more indicators of said medical device.

2. A method as recited inclaim 1, wherein said measuring a physical characteristic comprises determining the distance between two of said two or more indicators.

3. A method as recited inclaim 1, wherein said positioning comprises moving a delivery device linked to said medical device.

4. A method as recited inclaim 1, wherein said physical characteristic comprises the width of a tunnel of a PFO.

5. A method as recited inclaim 1, wherein said medical device comprises a PFO closure device.

6. A method as recited inclaim 1, wherein at least one of said two or more indicators comprises a dense material associated with said medical device.

7. A method as recited inclaim 1, wherein at least one of said two or more indicators comprises a radiopaque material.

8. A method for measuring the tunnel width of a Patent Foramen Ovale, comprising the steps of:

locating at least a portion of a medical device in a tunnel of the Patent Foramen Ovale of a heart, said medical device comprising a multi-cellular body portion, a first anchor linked to said multi-cellular body structure and a second anchor linked to said multi-cellular body structure;

positioning said first anchor against a left atrial wall of the heart;

deploying said second anchor; and

measuring the tunnel width of at least a portion of the tunnel of the Patent Foramen Ovale utilizing at least one of said first anchor, said second anchor or said multi-cellular body portion.

9. A method as recited inclaim 8, wherein said locating comprises inserting at least a portion of a delivery device into the heart.

10. A method as recited inclaim 8, wherein said positioning comprises moving a delivery device in a distal direction.

11. A method as recited inclaim 8, wherein said positioning comprises moving a handle body of a delivery device.

12. A method as recited inclaim 8, wherein said deploying said second anchor comprises rotating an actuating assembly of a delivery device.

13. A method as recited inclaim 8, further comprising deploying said first anchor in the left atrium of the heart.

14. A method as recited inclaim 8, wherein said measuring comprises measuring a distance between two or more indicators positioned on said medical device.

15. A method for verifying the placement of a medical device, comprising the steps of:

deploying at least a portion of a first anchor of a medical device in the left atrium of a heart, said medical device comprising a multi-cellular structure operatively associated with said first anchor, a second anchor operatively associated with said multi-cellular structure, and two or more indicators;

deploying at least a portion of said second anchor in at least one of a tunnel of a Patent Foramen Ovale or the right atrium of the heart; and

estimating placement of said medical device with respect to the Patent Foramen Ovale utilizing said two or more indicators.

16. A medical device as recited inclaim 15, wherein said first anchor is deployed by a first movement of an actuating assembly of a delivery device.

17. A medical device as recited inclaim 15, wherein said second anchor is deployed by a second movement of the actuating assembly of a delivery device.

18. A medical device as recited inclaim 15, wherein said two or more indicators are positioned on said first anchor.

19. A medical device as recited inclaim 15, wherein said two or more indicators are positioned on said multi-cellular structure.

20. A medical device as recited inclaim 15, wherein said estimating comprises determining the relative positions of said two or more indicators after said second anchor is deployed.

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