US20070167981A1 - Catch members for occluder devices - Google Patents

Abstract

Devices and techniques for modifying and maintaining a configuration of an occlusion device for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale (PFO), and other septal and vascular defects are described. The devices and techniques relate particularly to, but are not limited to, modifying and maintaining a configuration of a PFO occluder made from a polymer tube. The proximal portion of a catch member may be provided with one or more protrusions, or arms, or bump or other raised element for securing the occluder in a partial or fully deployed configuration, either temporarily or permanently.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This Application claims the benefit of priority to U.S. Provisional Application Ser. No. 60/753,681, filed Dec. 22, 2005, the disclosure of which is incorporated by reference herein.
FIELD OF THE INVENTION
• This invention relates generally to occlusion devices for the closure of physical anomalies, such as an atrial septal defect, a patent foramen ovale, and other septal and vascular defects. The invention also relates to mechanisms for deploying such devices and securing them in the deployed position.
BACKGROUND OF THE INVENTION
• A patent foramen ovale (PFO), illustrated inFIG. 1, is a persistent, one-way, usually flap-like opening in the wall between theright atrium11 andleft atrium13 of theheart10. Because left atrial (LA) pressure is normally higher than right atrial (RA) pressure, the flap usually stays closed. Under certain conditions, however, right atrial pressure can exceed left atrial pressure, creating the possibility that blood could pass from the right atrium11 to theleft atrium13 and blood clots could enter the systemic circulation. It is desirable that this circumstance be eliminated.
• The foramen ovale serves a desired purpose when a fetus is gestating. Because blood is oxygenated through the umbilical cord, and not through the developing lungs, the circulatory system of the fetal heart allows the blood to flow through the foramen ovale as a physiologic conduit for right-to-left shunting. After birth, with the establishment of pulmonary circulation, the increased left atrial blood flow and pressure results in functional closure of the foramen ovale. This functional closure is subsequently followed by anatomical closure of the two over-lapping layers of tissue:septum primum14 and septum secundum16. However, a PFO has been shown to persist in a number of adults.
• The presence of a PFO is generally considered to have no therapeutic consequence in otherwise healthy adults. Paradoxical embolism via a PFO is considered in the diagnosis for patients who have suffered a stroke or transient ischemic attack (TIA) in the presence of a PFO and without another identified cause of ischemic stroke. While there is currently no definitive proof of a cause-effect relationship, many studies have confirmed a strong association between the presence of a PFO and the risk for paradoxical embolism or stroke. In addition, there is significant evidence that patients with a PFO who have had a cerebral vascular event are at increased risk for future, recurrent cerebrovascular events.
• Accordingly, patients at such an increased risk are considered for prophylactic medical therapy to reduce the risk of a recurrent embolic event. These patients are commonly treated with oral anticoagulants, which potentially have adverse side effects, such as hemorrhaging, hematoma, and interactions with a variety of other drugs. The use of these drugs can alter a person's recovery and necessitate adjustments in a person's daily living pattern.
• In certain cases, such as when anticoagulation is contraindicated, surgery may be necessary or desirable to close a PFO. The surgery would typically include suturing a PFO closed by attaching septum secundum to septum primum. This sutured attachment can be accomplished using either an interrupted or a continuous stitch and is a common way a surgeon shuts a PFO under direct visualization.
• Umbrella devices and a variety of other similar mechanical closure devices, developed initially for percutaneous closure of atrial septal defects (ASDs), have been used in some instances to close PFOs. These devices potentially allow patients to avoid the side effects often associated with anticoagulation therapies and the risks of invasive surgery. However, umbrella devices and the like that are designed for ASDs are not optimally suited for use as PFO closure devices.
• Currently available septal closure devices present drawbacks, including technically complex implantation procedures. Additionally, there are significant complications due to thrombus, fractures of the components, conduction system disturbances, perforations of heart tissue, and residual leaks. Many devices have high septal profile and include large masses of foreign material, which may lead to unfavorable body adaptation of a device. Given that ASD devices are designed to occlude holes, many lack anatomic conformability to the flap-like anatomy of PFOs. Thus, when inserting an ASD device to close a PFO, the narrow opening and the thin flap may form impediments to proper deployment. Even if an occlusive seal is formed, the device may be deployed in the heart on an angle, leaving some components insecurely seated against the septum and, thereby, risking thrombus formation due to hemodynamic disturbances. Finally, some septal closure devices are complex to manufacture, which may result in inconsistent product performance.
• Various designs have disclosed septal closure devices made from a tube. These devices generally have a low septal profile in a delivery configuration, and a high septal profile in a deployed configuration. Upon deployment, these devices seal a septal defect. The unique design of these tube-made devices, however, requires an additional catch mechanism to catch the devices in their deployed configurations.
• Various catch member designs have been proposed to catch the tube-made septal closure devices in the deployed configuration, temporary and permanently. Making such catch members capable of forming a temporary lock during partial deployment and a more secure permanent lock after full deployment has proved challenging. Some designs are not sufficiently reliable and other designs cannot be manufactured effectively. Finally, some designs, while workable on paper, do not perform satisfactorily in the human body.
• The septal closure devices and techniques disclosed herein are designed to address these and other deficiencies of prior art design and techniques for delivering and retrieving such devices.
BRIEF SUMMARY OF THE INVENTION
• In some aspects, the present invention includes several delivery devices and techniques for delivering an implant into a desired location within the body. This delivery technique relates particularly to, but is not limited to, a septal occluder made from a polymer tube. These delivery techniques, in addition to use with septal occluders, can be applied to other medical devices, such as other expandable devices constructed to be delivered in a reduced profile configuration to an expanded profile or delivered configuration.
• Catch members may be used to deploy and keep the device in place. According to some embodiments, the catch member maintains a reduced axial length of the device when the device is in the deployed configuration. Also, varied constructions could be used to maintain the axial dimension of the device, such as different locking mechanisms. Preferably, the catch member secures both sides of the device in the reduced profile configuration with a single element. Generally, during the delivery stage, the catch member has a smaller diameter at its proximal end compared to the diameter of the proximal end of the occluder. This configuration allows the proximal end of the occluder to slide over the proximal end of the catch member during deployment sequence. This may be achieved by compression of the proximal end of the catch member, by expansion of the proximal end of the occluder, or a combination of both. In a catching configuration, the catch member generally has a greater diameter at its proximal end compared to the diameter of the proximal end of the occluder, which keeps the occluder in its deployed configuration.
• In various embodiments, the catching configuration can be temporary or permanent. A temporary catch configuration generally allows for the catch member to release, while a permanent catch configuration generally is not designed for release. Some embodiments have a temporary catch configuration, which allows for confirmation of proper deployment, and a permanent catch configuration, that is engaged when proper deployment is confirmed.
• In certain embodiments, a permanent catch configuration can, for example, have a greater diameter at the proximal end of the catch member than a temporary catch configuration. A temporary catch configuration is generally preferred during evaluation and repositioning of a device, such as an occluder, while a permanent catch configuration is generally preferred once the device is deployed.
• According to at least some embodiments, the catch member is formed from a tube. According to some embodiments, the tube includes a material selected from the group consisting of metals, shape memory materials, alloys, polymers, bioabsorbable polymers, and combinations thereof. In particular embodiments, the tube includes a shape memory polymer. In particular embodiments, the tube includes nitinol. In some embodiments, the tube is formed by rolling a flat piece of material into a tubular form. According to some embodiments, the catch member is formed by cutting the tube. The catch member is placed in its deployment configuration by fixing the axial length of the device, for example by preventing the proximal end of the device from sliding over the proximal catch element.
• In some embodiments, the catch member uses a partially cut tube, with an axis of the proximal portion of the tube at an angle with respect to the axis of the distal side of the tube. A portion of the proximal side of the tube catches the proximal end of the device and keeps it in a deployed position.
• In some embodiments, the catch member uses a series of protrusions at its proximal end. Once the protrusions are released, for example by removing the delivery wire, the protrusions project radially outward from the proximal side of the tube and keep the device in its locked position by preventing the proximal end of the device from sliding over the protrusions. In various embodiments, the protrusions are biased towards the proximal or the distal end of the catch member. In some embodiments, they may be twisted relative to the axis of the catch member.
• In certain embodiments, the catch member may include a bump and pre-curved tabs at its proximal side. The bump is interrupted by a largely planar lumen slicing through the proximal side of the catch member. The lumen allows compression of the catch member with the delivery wire attached to provide a temporary catch configuration. In some embodiments, after the delivery wire is removed, the tabs automatically slide into the lumen to prevent or reduce compressibility of the catch member, thus providing a permanent catch configuration.
• In a further aspect, the catch member may include a delivery wire and a catch tube that is threadedly secured to the delivery wire at two different locations. Each threaded connection has different pitches. Twisting of the delivery wire with respect to the catch tube creates a temporary or permanent catch depending on the selected design criteria. This system is especially adapted to construction with malleable materials. In another aspect, the protrusions can be threaded with different pitches to allow for modulation of the protrusion configuration by twisting the delivery wire.
• These and other aspects and embodiments of the disclosure are illustrated and described below.
BRIEF DESCRIPTION OF THE DRAWINGS
• In the Drawings:
• FIG. 1 is a schematic representation of a human heart including various septal defects;
• FIG. 2 shows an occluder and a catch member according to one embodiment of the disclosure;
• FIG. 3 illustrates an occluder and a catch member during the initial stage of deployment according to one embodiment of the invention;
• FIG. 4 illustrates an occluder and a catch member with the distal side of the occluder in its deployed configuration according to one embodiment of the invention;
• FIG. 5 illustrates an occluder and a catch member in a deployed configuration according to one embodiment of the invention;
• FIG. 6 is a view of cuts made during manufacture of a catch member according to one embodiment of the invention;
• FIG. 7 is a view of a catch member according to one embodiment of the invention;
• FIG. 8 is a cross-sectional view of the catch member along lines8-8 inFIG. 7 according to one embodiment of the invention;
• FIG. 9 is an exploded cross-sectional side view of the catch member along lines9-9 inFIG. 8 according to one embodiment of the invention;
• FIG. 10 is a cross-sectional side view of one step in a deployment sequence according to one embodiment of the invention;
• FIG. 11 is a cross-sectional side view of one step in a deployment sequence according to one embodiment of the invention;
• FIG. 12A is a cross-sectional side view of a deployed occluder and a catch member according to one embodiment of the invention;
• FIG. 12B is a cross-sectional side view of a deployed occluder and a catch member according to one embodiment of the invention;
• FIG. 13 is an axial cross-sectional drawing of an occluder and a catch member, in a delivery configuration, according to one embodiment of the invention;
• FIGS. 14-17 are cross-sectional side views of various steps in a deployment sequence according to one embodiment of the invention;
• FIGS. 18-22 are cross-sectional side views of various steps in a retrieval sequence according to one embodiment of the invention;
• FIG. 23 is a cross-sectional side view of a detachment step according to one embodiment of the invention;
• FIG. 24 is an exploded view of an embodiment of the distal portion of the catch member according to one aspect of the invention;
• FIG. 25 is a view of the cut(s) made during the manufacture of a catch member according to one embodiment of the invention;
• FIG. 26 is a cross-sectional view of a step in the manufacture of the catch member according to one embodiment of the invention;
• FIG. 27 is an exploded cross-sectional view of the catch member according to one embodiment of the invention;
• FIG. 28 is an exploded cross-sectional side view of the catch member along lines28-28 inFIG. 27 according to one embodiment of the invention;
• FIGS. 29-30 are cross-sectional side views of various steps in the deployment sequence according to one embodiment of the invention;
• FIG. 31 is a cross-sectional side view of the delivery system during the detachment process according to one embodiment of the invention;
• FIG. 32 is a view of cuts made during manufacture of a catch member according to one embodiment of the invention;
• FIG. 33 is a view of a step in the manufacture of a catch member according to one embodiment of the invention;
• FIG. 34 is an expanded cross-sectional side view of the catch member according to one embodiment of the invention;
• FIG. 35 is an exploded cross-sectional side view of the catch member along lines35-35 inFIG. 34 according to one embodiment of the invention;
• FIGS. 36-37 are cross-sectional side views of various steps in the deployment sequence according to one embodiment of the invention;
• FIG. 38 is a cross-sectional side view of the delivery system during the detachment process according to one embodiment of the invention;
• FIG. 39 is a view of a catch member according to one embodiment of the invention;
• FIG. 40 is a view of a catch member according to one embodiment of the invention;
• FIG. 41 is a view of cuts made during manufacture of a catch member according to one embodiment of the invention;
• FIG. 42 is a view of a catch member according to one embodiment of the invention;
• FIG. 43A illustrates an embodiment of the proximal catch element in a starting configuration according to one aspect of the invention;
• FIG. 43B illustrates an embodiment of the proximal catch element in a temporary catch configuration according to one aspect of the invention;
• FIG. 44 illustrates an embodiment of the proximal catch element in a permanent catch configuration according to one aspect of the invention;
• FIG. 45A illustrates a step in the manufacture of the catch member according to one embodiment of the invention;
• FIGS. 45B, 45D,45F and45H illustrate an embodiment of the catch member in a permanent catch configuration according to one aspect of the invention; and
• FIGS. 45C, 45E,45G and45I illustrate an embodiment of the catch member in a temporary catch configuration according to one aspect of the invention.
DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS
• Aspects of the present invention provide devices, delivery/retrieval systems and techniques for delivering such devices intended to occlude an aperture within body tissue. In particular, and as described in detail below, the described occluder may be used for closing an ASD, VSD or PFO in the atrial septum of a heart. Although the embodiments are described with reference to an ASD, VSD or PFO, one skilled in the art will recognize that the device and methods of the present invention may be used to treat other anatomical conditions. As such, the invention should not be considered limited in applicability to any particular anatomical condition. In addition, the systems and methods for delivery and retrieval, and for catching a device in a deployed state, that are aspects of the present invention may also be used in connection with other types of devices besides an occluder, in particular, devices having tubular profiles.
• FIG. 1 illustrates ahuman heart10, having aright atrium11 and aleft atrium13 and including variousanatomical apertures18aand18b. Theatrial septum12 includes septum primum14 andseptum secundum16. The anatomy of theseptum12 varies widely within the population. In some people, septum primum14 extends to and overlaps withseptum secundum16. The septum primum14 may be quite thin. When the anatomical apertures18ais present, blood could travel through the anatomical aperture18abetween septum primum14 and septum secundum16 (referred to as “the PFO tunnel”). Additionally, or alternatively, the presence of an ASD could permit blood to travel through an aperture in the septal tissue, such as through theanatomical aperture18b.
• this application, “distal” refers to the direction away from a catheter insertion location and “proximal” refers to the direction nearer the insertion location. Additionally, the term “delivery configuration” refers to the configuration of a device, such as an occluder, when it has a reduced profile in a delivery sheath or catheter. The term “deployed configuration” refers to the configuration of the device, such as an occluder, when it has deployed from the catheter, such as at the desired implantation location.
• FIGS. 2-5 illustrate an exemplary occluder with which systems and techniques disclosed herein may be used. Acatch member50 contains aproximal catch element52 and a distal catch element, such as aflange54, and is designed to be disposed at the distal end oftube25 ofoccluder70.Occluder70, for example, can be formed by cutting a series of slits ontube25. As shown inFIGS. 3-5,distal petals32 are produced by cuttingslits31 in the upper portion oftube25 according to the cutting pattern shown inFIG. 2. As shown inFIG. 3, the distal portion of thetube25 is cut in half to formhalf sections91aand91b. Thehalf sections91aand91bare further cut to a proximal distance fromdistal tip39 intoquarter sections92a,93a,92b, and93b. The cuts are discontinued andquarter sections92aand92bform half section94aatdistal tip39, andquarter sections93aand93bform half section94batdistal tip39. Upon application of force F_dtodistal tip39, struts defined byslits31 bow and twist outward to formdistal petals32 indistal side30, as shown inFIGS. 4-5. The movement of the struts during deployment is such that the struts rotate in an orthogonal plane relative to the axis of the device.Central tube22 may be constrained during the application of force F_d, or any combination of forces sufficient to reduce the axial length of thetube25 may be applied. One end of each ofdistal petals32 originates fromcentral tube22, while the other end originates from distal tip39 (FIGS. 3-4).Proximal petals42 may be formed inproximal side40, as shown inFIGS. 3-5, makingslits41 betweencentral tube22 andproximal tip44, using the same cutting pattern described above.
• The tube(s)25 formingoccluder70 may be formed from a biocompatible metal or polymer. In at least some embodiments,occluder70 is formed of a bioabsorbable polymer, or a shape memory polymer. Shape memory polymers can be advantageous so that the structure of the device assists in pressing the PFO tunnel closed. In other embodiments,occluder70 is formed of a biocompatible metal, such as a shape memory alloy (e.g., nitinol). The thermal shape memory and/or superelastic properties of shape memory polymers and alloys permitoccluder70 to resume and maintain its intended shape in vivo despite being distorted during the delivery process. Alternatively, or additionally,occluder70 may be formed of a bioabsorbable metal, such as iron, magnesium, or combinations of these and similar materials. Exemplary bioabsorbable polymers include polyhydroxyalkanoate compositions, for example poly-4-hydroxybutyrate (P4HB) compositions, disclosed in U.S. Pat. No. 6,610,764, entitled Polyhydroxyalkanoate Compositions Having Controlled Degradation Rate and U.S. Pat. No. 6,548,569, entitled Medical Devices and Applications of polyhydroxyalkanoate Polymers, both of which are incorporated by reference in their entirety.
• The cross-sectional shape oftube25 may be circular or polygonal, for example square, pr hexagonal. Theslits31 and41 may be disposed on the face of the polygon (i.e., the flat part) or on the intersection of the faces.
• The tube can be injection molded, extruded, or constructed of a sheet of material and rolled into a tube. The sheet of material could be a single ply sheet or multiple ply. The slits that form the struts could be cut or stamped into the sheet prior to rolling the sheet into a tube to connect the ends to form an enclosed cross section. Various geometrical cross sections are possible including circular, square, hexagonal and octagonal and the joint could be at the vertex or along the flat of a wall if the cross section is of a particular geometry. Various attachment techniques could be used to join the ends of the sheet to form a tube, including welding, heat adhesives, non-heat adhesives and other joining techniques suitable for in-vivo application.
• The petal configuration is the deployed configuration.Occluder70 can be secured in the petal configuration by a catch member that holds the ends of thetube25 together, certain embodiments of which are described below. Use of the terms distal and proximal sides orportions30 and40, respectively, include the petals that are formed on the distal and proximal sides.
• The embodiment described in conjunction withFIGS. 2-5 has similarities to the devices disclosed in U.S. patent application Ser. No. 10/890,784, entitled Tubular Patent Foramen Ovale (PFO) Closure Device with Locking Mechanism, filed on Jul. 14, 2004; U.S. patent application Ser. No. 11/070,027, entitled Delivery/Recovery System for Clover Leaf Septal Occluder, filed on Mar. 2, 2005; U.S. patent application Ser. No. 11/235,661, entitled Occluder Device Double Securement System for Delivery/Recovery of Such Occluder Device, filed Sep. 16, 2005; U.S. patent application Ser. No. 11/384,635, filed Mar. 20, 2006, entitled Catch Member for PFO Occluder; U.S. patent application Ser. No. 60/662,990, filed Mar. 18, 2004, entitled Suture Delivery/Recovery System for PFO Occluder with Catch System; and U.S. patent application Ser. No. 11/395,718, entitled Tubular Patent Foramen Ovale (PFO) Closure Device with Catch System, filed Mar. 31, 2006; all of which have the same assignee as the present application, and are incorporated by reference in their entirety. These incorporated documents describe how a device can be formed by making cuts or slits in a tube and compressing the ends, and how to deliver such a device. Embodiments of the catch members described herein are not restricted to the particular embodiment of occluder shown inFIGS. 2-5 and may be used with a number of devices and, in particular, may be used in conjunction with various devices described in the aforementioned patent applications.
• In one alternate embodiment of an occluder, one end of each of distal petals originates from a central tube, while the other end originates from the distal end. Upon application of a force to the distal end to reduce the axial length, extended segments defined by slits in the tube bow and twist outward to form the distal petals in the distal side of the occluder. The movement of the segments during deployment is such that the segments rotate in an orthogonal plane relative to the axis of the device. The central tube may be constrained during the application of force, or any combination of forces sufficient to reduce the axial length of the tube may be applied. This embodiment is illustrated, for example, inFIGS. 2E-2H of U.S. patent application Ser. No. 11/395,718, which has been incorporated by reference above.
• The transformable design ofoccluder70 enablesoccluder70 to be delivered in a low profile, tubular form and to be converted readily, i.e., by reducing the axial length, in place to the high-profile deployed configuration. Moreover, the conversion can readily be effected by forcingdistal tip39 andproximal tip44 together. For example,distal side30 andproximal side40 ofoccluder70 may be deployed in separate steps, or bothdistal side30 andproximal side40 ofoccluder70 may be exposed (e.g., out of the delivery catheter) prior to engaging the catch member and deployed together as the catch member is engaged.
• Occluder70 may be prepared for delivery to anaperture18aor18bin any one of several ways.Slits31 and41 may be cut such thattube25 bends into its intended configuration following deployment in vivo. Specifically, slits31 and41 may be cut to producestruts32 and42 of a thickness that facilitates the bending and formation ofloops32 and42 upon the application of forces F_dand/or F_pduring deployment. SeeFIGS. 3 and 4. Alternatively and/or additionally, atube25 formed of a shape memory material may be preformed into its intended configuration ex vivo so that it will recover its preformed shape once deployed in vivo. According to at least some embodiments, this preforming technique produces more reliable deployment and bending ofoccluder70 in vivo. An intermediate approach may also be used:tube25 may be only slightly preformed ex vivo such that it is predisposed to bend into its intended shape in vivo upon application of forces F_dand F_p.
• An embodiment of the catch member according to one aspect of the invention is illustrated inFIGS. 6-9.FIGS. 6 and 7 illustrate aspects of the manufacture of thecatch member100. Specifically, slits103 (which include atransverse slit103aandaxial slits103b) are cut into theproximal side106 of thecatch tube102 to createarms104, each arm having adistal surface104a. Twoarms104 are illustrated. Of course, any number greater than one is possible. The geometrical constraints of the tube and manufacturing constraints of the slits would allow for up to 8 arms.Catch tube102 is illustrated with a threadedportion117, which is used to secure the delivery wire to the catch member, acentral lumen112 into which the delivery wire is adapted to go and adistal catch element110 at thedistal side108 of the tube that serves to hold the distal end of the catch member to the occluder. The threadedportion117 can be located at theproximal side106 or thedistal side108 of thecatch tube102. By pushingarms104 towards theproximal side106 of the tube,arms104 can be conditioned into a bent configuration as illustrated onFIG. 7.FIG. 8 illustrates the axial view of thearms104 along lines8-8 inFIG. 7. The conditioning process may include and can be enhanced by an annealing process, which can provide additional shape stability to thearms104. After the conditioning process,arms104 expand beyond the outside diameter of thecatch tube102. An expanded cross-sectional view ofarms104 in the bent configuration along lines9-9 inFIG. 8 is shown inFIG. 9.FIG. 9 illustratesrecess118 created by the conditioning ofarms104 into the bent configuration. The arms can also be called “tabs”, “stays”, “holders”, or any other suitable word or phrase. Referring toFIGS. 2-5, thedistal side108 of the catch tube may be ultrasonically welded tooccluder70, or some other fixing agent, such as glue, can be used. Also referring toFIGS. 2-5, thecatch tube102 is slidably disposed within thecentral tube22 ofoccluder70, and therefore,central tube22 is able to slide against thecatch tube102 during the deployment and retrieval ofoccluder70.
• FIGS. 10 and 11 illustrate steps in the deployment of the catching mechanism according to one embodiment of the disclosure.Occluder70 is introduced to anaperture18aor18bby adelivery sheath154 in its delivery configuration. Thedelivery catheter152 is positioned within thedelivery sheath154 with minimal clearance between them. The distal end of thedelivery catheter152 includes a threadedportion153. In one embodiment, the threadedportion153 is connected with the threadedportion150 of theproximal tip44 of the occluder. Thedistal tip39 of the occluder is threadably connected to thedelivery wire156 at the threadedportion117 of thecatch tube102. As shown inFIG. 10, the delivery wire has arecess157, illustrated as a narrowing in the circumference, into which thearms104 are rested, in unlocked position, during the delivery process. Therecess157 can vary in size and in some designs may be optional. As discussed above, the threadedportion117 can be located at theproximal side106 or at thedistal side108 of thecatch tube102.
• Referring toFIG. 10, thedistal side30 ofoccluder70 is exposed by withdrawingdelivery sheath152 proximally while holdingdelivery catheter154 anddelivery wire156 stable. Thedistal side30 ofoccluder70 is deployed by advancingdelivery catheter154 distally to reduce the axial length between thecentral tube22 and thedistal tip39 ofoccluder70, while holdingdelivery sheath152 anddelivery wire156 in place. Alternatively, thedistal side30 ofoccluder70 is deployed by withdrawingdelivery wire156 proximally to reduce the axial length between thecentral tube22 and thedistal tip39 ofoccluder70, while holdingdelivery sheath152 anddelivery catheter154 in place. Still referring toFIG. 10, theproximal side40 ofoccluder70 is exposed by further withdrawingdelivery sheath152 proximally while holdingdelivery catheter154 anddelivery wire156 in place. Theproximal side40 ofoccluder70 is deployed by advancingdelivery catheter154 distally to reduce the axial length between thecentral tube22 and theproximal tip44 ofoccluder70, while holdingdelivery sheath152 anddelivery wire156 in place. Alternatively,proximal side40 ofoccluder70 is deployed by withdrawingdelivery wire156 proximally to reduce the axial length between thecentral tube22 and theproximal tip44 of theoccluder70, while holdingdelivery sheath152 anddelivery catheter154 in place. Referring toFIG. 11,occluder70 is locked in its deployed configuration as theproximal tip44 is advanced beyondarms104. In this embodiment,arms104 are partially activated, i.e. released into the temporary catch configuration illustrated inFIG. 11, whensurface156aof thedelivery wire156 collides with thedistal surface104aofarms104.Occluder70 is then released by unscrewing the threadedportion153 of thedelivery catheter152 from the threadedportion150, and unscrewing the threadedportion117 of thecatch tube102 from thedelivery wire156. Withdrawal ofdelivery catheter152releases arms104 into a permanent catch configuration illustrated inFIGS. 7-9.
• FIG. 12A illustrates an alternative embodiment of the catch member after thedelivery wire156 has been unscrewed and withdrawn. InFIG. 12A, the embodiment of the proximal catch member hasstraight arms180 withtips182 exerting force against theproximal edge151 of the threadedportion150. As illustrated, the outer rim of the proximal edge touchestips182.
• FIG. 12B illustrates an alternative embodiment of the catch member after thedelivery wire156 has been unscrewed and withdrawn. InFIG. 12B, the embodiment of the proximal catch member has V-shapedarms200 withtips202 restraining movement of theproximal surface151aof theproximal edge151 of the occluder to prevent the occluder from expanding axially into its delivery configuration. While the embodiments ofFIG. 12A and 12B are illustrated with the threadedportion117 at the distal side ofarms104, the threaded potion can also be located at the proximal side ofarms104.
• FIG. 13 illustrates the initial step for a typical delivery sequence in accordance with one aspect of the disclosure.Occluder224 and catchmember222 are secured to thedelivery catheter152 and to thedelivery wire156, respectively. The threaded portion of thedelivery catheter153 is screwed onto the male threadedportion150 ofoccluder224. The threaded portion of thedelivery wire156 is screwed onto the female threadedportion117 of thecatch member222. Of course, the male and female threads can be reversed if desired. The distal end of thedelivery sheath154 with theenclosed occluder224 is inserted through the aperture to be occluded, such as theanatomical aperture18aor18bofFIG. 1, to approximately the midpoint of theoccluder224.
• Referring now toFIG. 14, thedistal side30 ofoccluder224 is deployed on the distal side of the aperture in theleft atrium13. Thedistal portion30 is deployed by first retracting thedelivery sheath154 to expose thedistal portion30 ofoccluder224. Force F₂is simultaneously applied to thedelivery catheter152 anddelivery wire156 to holdoccluder224 stationary. Referring now toFIG. 15, the axial length ofoccluder224 is then reduced by applying pulling force F₁on thedelivery wire156 with sufficient force to causearms104 of thecatch member222 to be pulled through thecentral tube22 ofoccluder224 and thedistal portion30 ofoccluder224 to compress and thedistal petals32 to form. Thecentral tube22 ofoccluder224 catches on thecatch member222. This holds thedistal petals32 in place while the remainder of the deployment sequence is carried out.
• Referring now toFIG. 16, theproximal side40 ofoccluder224 is deployed on the proximal side of the aperture in theright atrium11. Theproximal portion40 is deployed by first retracting thedelivery sheath154 to expose theproximal portion40 ofoccluder224. Theproximal petals42 are then formed by simultaneously advancing thedelivery catheter152 by applying force F₂and retracting thedelivery wire156 by applying force F₁to maintain the position ofoccluder224. Eventually, theproximal tip44 ofoccluder224 is pushed overarms104 of thecatch member222 andoccluder224 is caught on thedistal surface104aofarms104. After thedelivery catheter152 is detached fromoccluder224, the resulting configuration is illustrated inFIG. 17
• Occluder224 can now be evaluated for proper deployment at the desired location, for example by fluoroscopy or any other suitable technique with thedelivery system220, includingdelivery sheath154,delivery catheter152, anddelivery wire156 attached or partially detached. Thedelivery system220 can be partially detached by releasing the securement system provided by the threaded connection to the proximal tip of the occluder. As shown inFIG. 17, according to one preferred embodiment, to evaluate the proper deployment of the occluder, if desired, thedelivery sheath154 can be further retracted and thedelivery catheter152 can be detached fromoccluder224. Thedelivery catheter152 can be detached by applying torque to unscrew thedelivery catheter152 from the proximal threadedportion150 ofoccluder224 and retracting thedelivery catheter152. Thedelivery wire156 continues to secureoccluder224, as illustrated inFIG. 17. This affords the clinician a substantially unobstructed view of the occluder delivery site in order to evaluate the placement ofoccluder224. In addition, the more flexible distal portions of thedelivery catheter152 and thedelivery wire156 allow the distal end of thedelivery system220 and the deployed occluder to be re-positioned so that the view is not obstructed. The positioning ofoccluder224 can be evaluated using fluoroscopy or other appropriate techniques.
• If the delivery or deployment is not satisfactory, while thedelivery wire156 continues to secureoccluder224, then the occluder can be retrieved or repositioned in the sequence shown inFIGS. 18-22.
• As illustrated inFIG. 18, ifdelivery catheter152 has been detached, it is reattached by advancing the threadedportion153 of thedelivery catheter152 toward the threadedportion150 ofoccluder224 and applying torque until thedelivery catheter152 is threaded onto the threadedportion150 ofoccluder224, as illustrated inFIG. 18.
• Referring now toFIG. 19, thedelivery sheath154 is pushed towardsoccluder224. Then force F₃is applied to thedelivery catheter152 to pull theproximal portion40 ofoccluder224 over thearms104 of thecatch member222. Referring toFIG. 20, as thedelivery sheath154 is advanced distally to cover theproximal portion40 ofoccluder224, the axial length ofoccluder224 is increased, theproximal petals42 are unformed and theproximal portion40 ofoccluder224 returns to its tubular profile. Referring toFIG. 21, force F₅is applied to thedelivery sheath154 to advance it over theproximal portion40 ofoccluder224 and retain theproximal portion40 ofoccluder224 in the low-profile configuration. Also, force F₆is applied to thedelivery wire156 in order to release thedistal portion30 ofoccluder224 and further increase the axial length ofoccluder224.
• Referring now toFIG. 22, thedistal portion30 ofoccluder224 is fully extended back into its low-profile configuration and forces F₇and F₈are applied to thedelivery sheath154 and thedelivery catheter152 in order to retrieveoccluder224 back intodelivery sheath154.
• FIG. 23 illustrates the detachment of thedelivery wire156 from thecatch member222 when an occluder is fully deployed and its position is satisfactory. The threaded portion of thedelivery wire156 is unscrewed from the threadedportion117 of the catch member and thedelivery wire156 is then retracted into thedelivery catheter152. Thedelivery wire156, thedelivery catheter152 and thedelivery sheath154 are then removed from theheart10 by application of force F₉.
• FIG. 24 illustrates an embodiment of the distal end of thecatch member222, in which thedistal tip39 of the occluder is welded to thecatch tube102 using ultrasonic energy, heat, adhesive, or a solvent. Alternatively, both thecatch member222 and thecatch tube102 can be made of one piece. The threadedportion117 may be disposed anywhere along the axis of the catch tube. In a preferred form, the threadedportion117 may be immediately distal toarms104, not illustrated inFIG. 24.
• Another embodiment of the catch member according to the disclosure is illustrated inFIGS. 25-28.FIGS. 25 and 26 illustrate exemplary steps in the manufacture of acatch member300 by cutting aslit303 into theproximal side306 of thecatch tube302 to create a transverse, angled cut. The cut can be made at different angles with respect to the axis of thecatch tube302. In a preferred form, the cut can be at approximately 45 degrees.Catch tube302 is illustrated with acentral lumen312 and a threadedportion317 at thedistal side308 of the tube. The threadedportion317 may be at any location on the catch tube. In one embodiment, a distal catch element is attached to thedistal end308 of the catch member via ultrasonic welding, heat welding, solvent bonding, or adhesive. In another embodiment, thedistal side308 of thecatch tube302 is directly attached to thedistal end39 of the occluder via ultrasonic welding, heat welding, solvent bonding, or adhesive as shown, for example, inFIG. 24.
• By conditioning the axis of theproximal side306 to be at an angle, for example at a right angle, with respect to the axis of thedistal side308, theproximal side306 can be conditioned into a bent configuration, for example by annealing. An example of a step in this process is illustrated onFIG. 26, where an annealing wire316 is used to hold theproximal side306 and thedistal side308 in a non-parallel configuration to create anopening318.FIG. 27 illustrates an exploded cross-sectional view of thecatch member300 in a bent configuration. The axes of theproximal side306 anddistal side308 of thecatch tube302 are shown at approximately a right angle, although smaller and larger angles are also encompassed by this disclosure.FIG. 28 illustrates a view of theproximal side306 along lines28-28 inFIG. 27, with the catchingsurface304aof the catchingtip304ashown.
• FIGS. 29 and 30 illustrate steps of the deployment sequence of the occluder according to one embodiment of the disclosure. Referring toFIG. 29, in one embodiment, the threadedportion153 of thedelivery catheter152 is connected with the threadedportion150 of theproximal tip44 of the occluder. Thedistal tip39 of the occluder is threadably connected to thedelivery wire156 at the threadedportion317 of thecatch tube302. With theproximal side306 and thedistal side308 of thecatch tube302 axially aligned and thedelivery wire156 held in place,delivery sheath154 is withdrawn proximally to expose thedistal side30 of the occluder,delivery catheter152 is pushed towards thedistal tip39 of the occluder to deploy thedistal side30. Referring now toFIG. 30, theproximal side40 of the occluder is exposed by further withdrawingdelivery sheath154 proximally while holdingdelivery catheter152 anddelivery wire156 in place. Theproximal side40 of the occluder is deployed by advancingdelivery catheter152 distally. Alternatively,proximal side40 of the occluder is deployed by withdrawingdelivery wire156 proximally.
• Referring toFIG. 31, upon full deployment of the occluder and upon satisfaction with its position, the occluder is released by unscrewing thedelivery catheter152 from the threadedportion150 of the occluder, next unscrewing thedelivery wire156 from the threadedportion317 of thecatch tube302, and finally withdrawingdelivery catheter152,delivery sheath154, anddelivery wire156 proximally. Once thedelivery wire156 is unscrewed from the threadedportion317 and withdrawn, theproximal side306 of thecatch tube302 and the catchingtip304 are released into the bent configuration, which secures the occluder in the deployed configuration.
• FIG. 31 illustrates a deployed occluder after thedelivery wire156 has been detached from the occluder. In this embodiment,surface150arests against the proximal side of thecatch tube306 and/or the catchingsurface304ato maintain the occluder in a deployed configuration.
• Another embodiment of a catch member according to the disclosure is illustrated inFIGS. 32-35.FIGS. 32 and 33 illustrate steps in the manufacture of thecatch member400 by cuttingslits403 into theproximal side406 of thecatch tube402.Catch tube402 is illustrated with acentral lumen412, a threadedportion417, astopper element414 and adistal catch element410. In one embodiment, thedistal catch element410 is attached to thedistal end39 of the occluder via ultrasonic welding, heat welding, solvent bonding, or adhesive as shown. In another embodiment, thedistal side408 of thecatch tube402 is directly attached to thedistal end39 of the occluder via ultrasonic welding, heat welding, solvent bonding, or adhesive as shown, for example, inFIG. 24. As illustrated inFIG. 33, thecatch member400 is conditioned to a deployed configuration by, for example, annealing withprotrusions404 formed. This can be done by applying forces F_mto reduce the axial length of thecatch tube402 while annealing thecatch tube402, which results in formation ofprotrusions404. While four protrusions are illustrated, more or fewer protrusions can be made and employed from thecatch tube402. InFIGS. 33-35, thecatch member400 is illustrated in a deployed configuration withprotrusions404 formed. InFIG. 32, thecatch member400 is in its delivery configuration with no protrusions formed as shown.
• FIG. 34 illustrates a more detailed cross-sectional view ofprotrusions404 and thestopper element414. Thestopper element414 is firmly attached to thetube402, and may contain one or more holes to connect the proximal lumen412ato thedistal lumen412b. The stopper element is used to provide a stop for the delivery wire when being screwed in.FIG. 35 illustrates a view along lines35-35 ofFIG. 33. While the number ofprotrusions404 illustrated inFIGS. 33-35 is four, a number greater or lesser than four is also encompassed by this disclosure.
• FIGS. 36 and 37 illustrate steps of the deployment sequence of the occluder according to one embodiment of the disclosure. Referring toFIG. 36, the threadedportion153 of thedelivery catheter152 is connected to the threadedportion150 of theproximal tip44 of the occluder. Thedistal tip39 of the occluder is threadably connected to thedelivery wire156 at the threadedportion417 of thecatch tube402. Thecatch member400 is converted into a delivery configuration by screwing thedelivery wire156 into the threadedportion417. As the delivery wire travels toward thedistal side408 of thecatch tube402, it hits thestopper element414. Further screwing elongatesprotrusions404 and converts thecatch member400 into its delivery configuration, as illustrated inFIGS. 36 and 37. Referring toFIG. 36, with thedelivery wire156 held in place, thedelivery sheath154 is withdrawn proximally to expose thedistal side30 of the occluder and thedelivery catheter152 is pushed towards thedistal tip39 of the occluder to deploy thedistal side30 of the occluder. Referring now toFIG. 37, theproximal side40 of the occluder is exposed by further withdrawing thedelivery sheath154 proximally, while holding thedelivery catheter152 and thedelivery wire156 in place. Theproximal side40 of the occluder is deployed by advancing thedelivery catheter152 distally. Alternatively, theproximal side40 of the occluder is deployed by withdrawing thedelivery wire156 proximally.
• Referring toFIG. 38, upon full deployment of the occluder and satisfaction with its position, the occluder is released by unscrewing thedelivery catheter152 from the threadedportion150 of the occluder, then unscrewing thedelivery wire156 from the threadedportion417 of thecatch tube402, and finally withdrawing thedelivery catheter152,delivery sheath154, anddelivery wire156 proximally. Once thedelivery wire156 is unscrewed from the threadedportion417 and withdrawn, thecatch member400 is released into its deployed configuration withprotrusions404 formed.
• The components of alternate embodiments of thecatch member400 described supra are described in connection withFIGS. 39-42.
• FIG. 39 illustrates thecatch member400 withprotrusions444 in the deployed configuration biased towards thedistal side408 of thecatch tube402. This biasing can be achieved by modification of the manufacturing process, a step of which is illustrated inFIG. 33.FIG. 40 illustrates thecatch member400 withprotrusions454 in the deployed configuration biased towards theproximal side406 of thecatch tube402. This biasing can be achieved by modification of the manufacturing process, a step of which is illustrated inFIG. 33. In particular, annealing can be used to create alternate shapes.
• FIG. 41 illustrates yet another alternative embodiment of thecatch member400. In this embodiment, slits463 are cut at an angle θ with respect to the axis of thecatch tube402. When forces are applied to compress theproximal side406 and thedistal side408 of thecatch tube402, as illustrated for example inFIG. 33, theproximal side406 will twist with respect to thedistal side408, which will result inprotrusions464 having a twisted shape as illustrated inFIG. 42.
• FIGS. 43A, 43B and44 illustrate another embodiment of the invention. In this embodiment, acatch system600 includes a temporary and a permanent catch that are achieved by abump601 on the proximal portion of a catch system, for example a catch tube by the use of two threads of different pitches. During manufacture of the catch system,bump601 is formed on the proximal side of the tube by a material processing technique such as annealing. The use of two different pitches allows the catch member to be elongated in a delivery (reduced profile) configuration when a delivery wire is attached to the catch member. As the delivery wire is unscrewed from the catch member, the bump re-forms to provide a catch.
• FIG. 43A illustrates a cross-section of the proximal portion of the catch member during the deployment stage. The proximal end of the catch member, proximal to bump601, rests on the proximal section of thedelivery wire604. Aproximal section605 of thedelivery wire604 has a larger diameter than the distal section of thedelivery wire606. The difference in diameters can be smaller or larger than the difference illustrated inFIGS. 43A, 43B and44. In one embodiment, diameters of the proximal section of thedelivery wire604 and the distal section of thedelivery wire606 may be nearly identical.
• Still referring toFIG. 43A, a delivery wire has a smaller diameter at itsdistal section606 and a larger diameter at itsproximal section604. The difference in diameters can be smaller or larger than the difference illustrated inFIGS. 43A, 43B, and44. The proximal side of thedelivery wire604 has athread614 and the distal side of thedelivery wire606 has athread616. Theproximal end602 of thecatch member600 has amatching thread612 tothread614 of the same pitch. Thedistal end603 of the catch member has amatching thread613 tothread616 of the same pitch.Thread614 has a larger pitch thanthread616, by at least 0.01 of an inch.
• During the occluder delivery process, thedelivery wire605 is advanced distally by threadably connecting threadedportion613 of thedelivery wire605 and the threadedportion616 of thecatch member600, and threadedportion614 of thedelivery wire605 and the threadedportion612 of thecatch member600. Because threadedportions613 and616 have a smaller pitch than threadedportions612 and614, this results in theproximal end602 advancing in the direction, indicated by arrow A relative to thedelivery wire605, faster than thedistal end603. Bump601 of thecatch member600 is therefore elongated, and thecatch member600 is reduced to its delivery profile. The resultant configuration is illustrated inFIG. 43B.
• FIG. 43B illustrates the catch member in the delivery stage of the deployment process. In this delivery configuration,bump601 is reduced to a lower-profile configuration, allowing for a device, such as an occluder, to slide more easily overbump601. In this configuration, with thedelivery wire605 still attached, thecatch member600 could temporarily catch the occluder during its deployment with its proximal section of larger diameter. This may be useful during deployment, retrieval, repositioning or evaluation of deployment of an occluder. Once this is satisfactory, thedelivery wire605 can be removed by withdrawing it proximally. Removal of thedelivery wire605 results in theproximal end602 moving in direction B faster than thedistal end603, creating the high-profile configuration ofbump601 as illustrated inFIG. 44. Generally, it may be desirable that this be accomplished in 1-10 turns, more preferably within 3-5 turns. Examples of suitable pitches include 0.011 inch pitch for threadedportion613 of thecatch member600 and threadedportion616 of the threadedwire605, and 0.030 inch pitch for threadedportion612 of thecatch member600 and threadedportion614 of the threadedwire605, or 0.011 inch pitch for threadedportion613 of thecatch member600 and threadedportion616 of the threadedwire605, and 0.025 inch pitch for threadedportion612 of thecatch member600 and threadedportion614 of the threadedwire605.
• FIG. 44 illustrates the catch member once the delivery wire has been detached and removed, creating a permanent catch for the occluder at its deployed configuration. As a result of the pressure onbump601, exerted by the proximal end of the occluder to be caught,proximal end602 of thecatch member600 may constrict, for example atthreads612, and create a permanent catch. Alternatively, the material may provide sufficient stability to allow the bump to maintain the device in the delivered configuration.
• Materials suitable for use with this embodiment include materials that are able to be easily deformed, for example metals, alloys, polymers, or combinations of these and similar materials. Examples include, but are not limited to, bioabsorbable polymers such as polyhydroxyalkanoate compositions such as poly-4-hydroxybutyrate, bioabsorbable metals such as iron and magnesium.
• FIG. 45A illustrates a step in the manufacture of the catch member according to one aspect of the disclosure.Catch tube502 is illustrated withlumen503,steps510,tabs514 andlumens505, located at theproximal side506 of the catch member.Tabs514 andsteps510 can be made of the same piece of material ascatch tube502, or they can be separate pieces made from the same, or different material. The vertical spacing betweensteps510 is equal or slightly larger than the height oftabs514 to allowtabs514 to slide betweensteps510 without leaving more than a minimal clearance betweensteps510 andtabs514. Bump504 (e.g. as shown inFIG. 45B) can be created, for example by compressing the proximal anddistal ends506 and508, respectively, of the catch tube during annealing, similar to a scheme illustrated inFIG. 33.
• FIG. 45B illustrates an embodiment of the catch member in a permanent catch configuration.Bump504 has an outside diameter D₁, which is larger than diameter oftube502. Alternate bump configurations, including, but not limited to arms, barbs or other protrusions, are also encompassed by this disclosure.Tabs514 are preformed, for example by annealing, into a curvilinear shape (although other suitable shapes also possible), such that when the catch member is not in contact with any other object (such as a delivery wire or an occluder),tabs510 slide betweensteps510 throughlumen505, so thattab tips515 protrude intolumen503. One function oftab tips515 protruding into the lumen is to prevent thebump504 from being compressed. This configuration can provide a permanent catch. This configuration is further illustrated inFIG. 45D, which is a view alonglines45D-45D inFIG. 45B. Another view of the same configuration is illustrated inFIG. 45F, which is a view alonglines45F-45F inFIG. 45D.FIG. 45H is a view along lines45G-45G inFIG. 45D.FIG. 45H illustrates howtabs514 prevent compression of the proximal side of thecatch member506 by sliding betweensteps510. Therefore, application of pressure onbump504 does not result in a substantively compressed configuration, also referred to as the temporary catch configuration, illustrated inFIGS. 45C, 45E,45G and45I.
• A temporary catch configuration may be desired during deployment, retrieval, repositioning or evaluation of deployment of a device, such as an occluder. As illustrated inFIG. 45C, the proximal end of thecatch member506 can be compressed in a direction that reduces the volume oflumen503. The vertical dimension oflumens505 is larger than the height oftabs514, to allow for compression oflumens505 when tabs514 (or tab tips515) occupylumens505 as illustrated. This compressed configuration enables a device, or a portion of a device, such as a proximal portion of anoccluder520 with an inner diameter D₄, to reversibly slide overbump504 by exerting enough force onbump504 to compress theproximal side506 of the catch member. In the compressed configuration,bump504 has an outer diameter D₂, which is smaller than diameter D₁(illustrated inFIG. 45B). A temporary catch configuration generally requires that the distal end of the delivery wire (not shown) occupies the distal portion oflumen503.
• FIG. 45E is a view alonglines45E-45E inFIG. 45C, which further illustrates the temporary catch configuration.Delivery wire516 is attached to the catch member and occupies a portion oflumen503.Tab tips515 rub against thedelivery wire516 and are pushed out oflumen503 as illustrated. The curvilinear shape oftabs514 results intabs514 curving around the outside ofsteps510, allowing the proximal side of thecatch member506 to be compressed so thatbump504 has outside diameter D₂. This configuration is further illustrated inFIG. 45G, which is a view along lines45G-45G inFIG. 45E.FIG. 45I illustrates howtabs514 allow compression of the proximal side of thecatch member506 by being positioned outside ofsteps510. Therefore application of pressure onbump504 will result in a compressed configuration.
• In embodiments of the invention, including the embodiments specifically illustrated and described herein, the catching configuration can be temporary or permanent. A temporary catch configuration generally allows for the catch member to release, while a permanent catch configuration generally is not designed for release. Certain embodiments have both a temporary catch configuration, which allows for confirmation of proper deployment, and a permanent catch configuration, that is engaged when proper deployment is confirmed. A permanent catch configuration can, for example, have a greater diameter at the proximal end of the catch member than a temporary catch configuration and may be engaged only after the device has been properly positioned. A temporary catch configuration is generally preferred during evaluation and repositioning of a device, such as an occluder, while a permanent catch configuration is generally preferred once the device is deployed.
• The embodiments and techniques described here are described preferably for use with a device made of a polymer and formed from a single tube, such that the tube is a single monolithic material. The catch mechanism can be all or partly monolithic or integral with the tubular structure, or there can be an absence of any type of bonding or rigid connection to the rest of the tubular structure, in which case there may be some spring force or other force that holds the locking mechanism in place. While the device is thus shown as being substantially formed from a single tubular body, the catch mechanism as described in the embodiments above could be used with other types of devices, including those formed from many pieces, and including devices formed from other materials, including metals, polymers, stainless steel or nitinol.
• The term “bioabsorbable,” as used in the description above, is also understood to mean “bioresorbable.”
• While the description above refers to wires, and while the term “wire” might convey a more rigid piece than a string, a suture or a filament, all these terms are essentially interchangeable, and further include embodiments in which the wire, string, suture or filament is a hollow tube or conduit to allow another wire, as needed, to pass through its longitudinal axis. Each wire, string, suture and filament can be composed of one or more wires, strings, sutures and filaments.
• In cases in which the device is made of a polymer, it can be desirable to add an additive or coating to the material to make it radiopaque to make it more visible in a wider variety of imaging techniques.
• It will be appreciated that while a particular sequence of steps has been shown and described for purposes of explanation, the sequence may be varied in certain respects, or the steps may be combined, while still obtaining the desired deployment or in some cases to effect deployment in a particular way. For example, the delivery sheath may be advanced or retracted at varying times and in varying degrees, the proximal and distal portions of the occluder may be deployed into the petal configuration in a different sequence, etc. In addition, the steps could be automated.

Claims (25)

1. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

a proximal side and a distal side;

an occluder portion movable between the first and second configurations; and,

a catch system for holding the medical device in the second configuration including a catch member with at least one arm disposed near the proximal end of the catch member, such that during deployment, the proximal end of the catch member is adapted to pass through an inner passageway of the occluder while the arm is depressed and to secure the device in the second configuration when the arm protrudes outside an outer diameter of the catch member.

2. The device ofclaim 1, wherein the arm is formed by cutting two parallel axial slits and one transverse slit into the catch member.

3. The device ofclaim 2, wherein the arm includes a bend and the bend causes the device to be secured in the second configuration.

4. The device ofclaim 3, wherein the arm is pre-conditioned in a bent position.

5. The device ofclaim 4, wherein the arm is pre-conditioned by annealing.

6. The device ofclaim 2, wherein the tip of the arm secures the device in the second configuration.

7. The device ofclaim 6, wherein the arm is straight.

8. The device ofclaim 6, wherein the arm is bent.

9. The device ofclaim 6, wherein the arm is bent into a V-shape.

10. The device ofclaim 2, wherein the catch system provides a permanent catch.

11. The device ofclaim 10, wherein the catch system further provides a temporary catch for use during deployment of the device.

12. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

a proximal side and a distal side;

an occluder portion movable between the first and second configurations; and, a catch system for holding the medical device in the second configuration including a catch member formed from a tube having a transverse, angled slit in the proximal side, such that during deployment, the proximal end of the catch member is adapted to pass through an inner passageway of the occluder while the tube is straight and to secure the device in the second configuration when the tube is bent at the cut.

13. The device ofclaim 12, wherein the slit is angled about 45 degrees from a longitudinal axis of the catch member.

14. The device ofclaim 12, wherein the catch member has a first axis and the proximal portion of the catch member when bent at the cut has a second axis at an angle to the first axis, and wherein the second axis is at an angle of approximately 90 degrees from the first axis.

15. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

a proximal side and a distal side;

an occluder portion movable between the first and second configurations; and,

a catch system for holding the medical device in the second configuration including a catch member with two matched transverse slits in the proximal side such that during deployment, the proximal end of the catch member is adapted to pass through an inner passageway of the occluder and to secure the device in the second configuration when the portion defined by the two slits forms a protrusion.

16. The device ofclaim 15, wherein the protrusion is defined by reducing the axial length of the catch member and annealing.

17. The device ofclaim 15, further comprising an inner threaded portion for receiving a delivery wire and a stopper element disposed inside the tube for stopping the delivery wire when being screwed into the inner threaded portion.

18. The device ofclaim 15, wherein the protrusion is biased in the proximal direction.

19. The device ofclaim 15, wherein the protrusion is biased in the distal direction.

20. The device ofclaim 15, wherein the slits are angled relative to a longitudinal axis of the catch member.

21. The device ofclaim 15, wherein the protrusion is twisted relative to the longitudinal axis of the catch member.

22. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

a proximal side and a distal side;

an occluder portion movable between the first and second configurations; and,

a catch system for holding the medical device in the second configuration including a catch member having a first outer diameter closer to the proximal end and having a second outer diameter further from the proximal end that is smaller than the first outer diameter, such that during deployment, the proximal end of the catch member is adapted to pass through an inner passageway of the occluder and to secure the device in the second configuration when a proximal end of the device catches on the first outer diameter.

23. The device ofclaim 22, wherein the catch member includes threads with two different pitches and the second outer diameter corresponds to threads with a first pitch.

24. The device ofclaim 22, further comprising a bump around the circumference of the catch member, wherein the first outer diameter corresponds to a diameter of the bump.

25. A collapsible medical device for occluding an aperture in a body, the medical device having a first configuration with a reduced profile and a second configuration with an expanded profile, the medical device being adapted to be delivered through a delivery system into a desired delivery location, the medical device comprising:

a proximal side and a distal side;

an occluder portion movable between the first and second configurations; and,

a catch system for holding the medical device in the second configuration including a generally tubular catch member with a proximal portion and a proximal end, having a raised portion around its outer circumference on the proximal portion, tabs axially extending toward the raised portion, and a planar lumen intersecting the proximal end of the catch member, such that during deployment, the proximal end of the catch member is adapted to pass through an inner passageway of the occluder and to temporarily secure the device in an intermediate configuration by compression of the lumen and to secure the device in the second configuration when a proximal end of the device engages the raised portion, the engagement with the raised portion being secured by the tabs.

Images