Search Images Maps Play YouTube News Gmail Drive More »
Sign in
Screen reader users: click this link for accessible mode. Accessible mode has the same essential features but works better with your reader.

Patents

  1. Advanced Patent Search
Publication numberUS20070265642 A1
Publication typeApplication
Application numberUS 11/796,937
Publication date15 Nov 2007
Filing date30 Apr 2007
Priority date14 Jan 2002
Also published asCA2471871A1, EP1471835A2, EP1471835A4, US7220265, US20030144694, WO2003059152A2, WO2003059152A3
Publication number11796937, 796937, US 2007/0265642 A1, US 2007/265642 A1, US 20070265642 A1, US 20070265642A1, US 2007265642 A1, US 2007265642A1, US-A1-20070265642, US-A1-2007265642, US2007/0265642A1, US2007/265642A1, US20070265642 A1, US20070265642A1, US2007265642 A1, US2007265642A1
InventorsAndrzej Chanduszko, Steven Opolski, Carol Devellian
Original AssigneeNmt Medical, Inc.
Export CitationBiBTeX, EndNote, RefMan
External Links: USPTO, USPTO Assignment, Espacenet
Patent foramen ovale (PFO) closure method and device
US 20070265642 A1
Abstract
The present invention provides methods and devices for closing two overlapping layers of tissue in a mammalian heart, for example a patent foramen ovale (PFO). The closure devices may take a number of different forms and may be retrievable. In some embodiments, a device is sized and shaped to extend from septum secundum, into the left atrium, through septum primum, and into the right atrium, such that the first and second ends cooperate to provide a compressive force to the overlapping layers of tissue. In some embodiments, the closure devices may be delivered with a catheter capable of puncturing mammalian tissue.
Images(11)
Previous page
Next page
Claims(19)
1. A device for closing two overlapping layers of septum primum and septum secundum dividing a left atrium and a right atrium in a mammalian heart, said device having first and second ends, wherein said device is sized and shaped to extend from septum secundum, into the left atrium, through septum primum, and into the right atrium, said first and second ends cooperating to provide a compressive force to the overlapping layers of tissue.
2. The device of claim 1, wherein said first end is embedded in, and does not extend through, septum secundum.
3. The device of claim 2, wherein said first end is formed into a coil, hook, corkscrew, or other anchor.
4. The device of claim 1, wherein said first end includes a material selected from the group consisting of bioresorbable materials, noble metals, shape memory materials, metals, polymeric materials, and swellable foams.
5. The device of claim 4, wherein said shape memory material includes nitinol.
6. The device of claim 1, wherein said first end includes a septal puncture needle capable of puncturing mammalian tissue.
7. The device of claim 1, further comprising a catheter containing said device in an elongated, low-profile form, said first end being expandable to form an anchor and said second end being adjustable to alter a compressive force applied to the overlapping layers of tissue.
8. The device of claim 1, wherein said device is sized and shaped to further extend to septum secundum in the right atrium.
9. The device of claim 8, wherein said device includes a ring with a gap terminating in first and second opposed, pointed ends for puncturing mammalian tissue.
10. The device of claim 9, wherein said device includes a material selected from the group consisting of flexible polymers, bioabsorbable materials, spring metals, and shape memory materials.
11. The device of claim 10, wherein said device includes nitinol.
12. The device of claim 9, wherein said device consists essentially of a monolithic partial ring.
13. The device of claim 9, wherein said device includes a gap slightly smaller than the thickness of the overlapping layers of tissue to which it is connected.
14. The device of claim 9, wherein said device includes a gap slightly smaller than the thickness of septum secundum.
15. The device of claim 9, wherein said first and second ends overlap each other.
16. The device of claim 1, wherein said device includes a partial ring with first and second ends and at least one fold therebetween.
17. The device of claim 16, wherein said at least one fold cooperates with said first and second ends to apply a compressive force to said overlapping layers of tissue.
18. The device of claim 16, wherein said device consists essentially of a monolithic partial ring.
19. The device of claim 1, wherein said device is sized and shaped to further contact the surfaces of septum primum exposed in both the left and right atria.
Description
    CROSS-REFERENCE TO RELATED APPLICATIONS
  • [0001]
    This Application is a Divisional of U.S. patent application Ser. No. 10/341,802, entitled Patent Foramen Ovale (PFO) Closure Method and Device, filed Jan. 14, 2003, and incorporated herein by this reference.
  • FIELD OF THE INVENTION
  • [0002]
    The invention relates to occlusion devices and methods for the closure of physical anomalies, like septal apertures, such as patent foramen ovale and other septal and vascular defects.
  • BACKGROUND OF THE INVENTION
  • [0003]
    A patent foramen ovale (PFO) as shown in FIG. 1, is a persistent, one-way, usually flap-like opening in the wall between the right atrium 10 and left atrium 12 of the heart. Since left atrial (LA) pressure is normally higher than right atrial (RA) pressure, the flap typically stays closed. Under certain conditions, however, RA pressure can exceed LA pressure creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation. In utero, the foramen ovale serves 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 primum 14 and septum secundum 16. However, a PFO has been shown to persist in a number of adults.
  • [0004]
    The cause of ischemic stroke remains cryptogenic (of unknown origin) in approximately 40% of cases. Especially in young patients, paradoxical embolism via a PFO is considered in the diagnosis. While there is currently no proof for 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 good evidence that patients with PFO and paradoxical embolism are at increased risk for future, recurrent cerebrovascular events.
  • [0005]
    The presence of a PFO has no therapeutic consequence in otherwise healthy adults. In contrast, patients suffering a stroke or transient ischemic attack (TIA) in the presence of a PFO and without another cause of ischemic stroke are considered for prophylactic medical therapy to reduce the risk of a recurrent embolic event. These patients are commonly treated with oral anticoagulants, which have the potential for adverse side effects, such as hemorrhaging, hematoma, and interactions with a variety of other drugs.
  • [0006]
    In certain cases, such as when anticoagulation is contraindicated, surgery may be used to close the PFO. To suture a PFO closed requires attachment of septum secundum to septum primum with either an interrupted or a continuous stitch, which is the common way a surgeon shuts the PFO under direct visualization.
  • [0007]
    Nonsurgical closure of PFOs has become possible with the advent of umbrella devices and a variety of other similar mechanical closure designs, developed initially for percutaneous closure of atrial septal defects (ASD). These devices allow patients to avoid the potential side effects often associated with anticoagulation therapies.
  • [0008]
    Currently available designs of septal closure devices, however, present such drawbacks as technical complexity of implantation procedure, high complication rates (thrombus, fractures, conduction system disturbances, perforations, residual leaks), high septal profile, large masses of foreign material, and lack of anatomic conformability especially to the PFO flap-like anatomy, as most were originally designed to close ASD's, which are true holes. Additionally, some septal closure devices are complex to manufacture, which can result in lack of consistency in product performance.
  • SUMMARY OF THE INVENTION
  • [0009]
    In one aspect, the present invention provides a method of closing two overlapping layers of tissue in a mammalian heart, e.g., a patent foramen ovale (PFO), using a closure device that applies a compressive force to at least one of the layers of tissue. The closure device may be retrievable, such that it may be removed after a period of time sufficient to allow the overlapping layers of tissue to fuse together. If necessary to sufficiently close the length of the layers of tissue, multiple closure devices may be administered. The closure devices may be delivered with a catheter capable of puncturing mammalian tissue in at least one location.
  • [0010]
    The closure device of the present invention may take a number of different forms. For example, the closure device may have first and second ends, both of which may be capable of puncturing mammalian tissue. The device may be a structure such as a ring with a gap, a folded ring, at least one grappling hook member joined to at least one curved arm by a joinder member, opposed grappling hook members joined by a central connecting member, a grappling hook member and a central connecting member, or a closure device anchor joined to a structure of sufficient diameter to hold the device in place against the overlapping layers of tissue. In some embodiments of the present invention, the closure device is sized and shaped such that it extends from septum secundum in the left atrium, into the left atrium, through septum primum, into the right atrium, and to septum secundum in the right atrium. Some retrievable devices include elongate tethers to facilitate their removal. Each of these devices has certain advantages, and one skilled in the art will be capable of selecting the device appropriate for a given application.
  • [0011]
    The ends of the closure device may also take a number of different forms. For example, at least one end may form a disc or a closure device anchor, such as a coil, hook, or corkscrew. These end structures help to maintain the device in place. One of the ends, for example the second end, may take the form of a knot or a structure similarly capable of holding the device in place and applying a sufficient compressive force to the overlapping layers of tissue. In some embodiments, the end structure may be adjusted to alter the compressive force applied to the overlapping layers of tissue. As previously mentioned, either or both of the first and second ends may be capable of puncturing mammalian tissue. In some embodiments, the first end of the device is a septal puncture needle.
  • [0012]
    The closure device may be formed of any of several materials, such as flexible polymer materials, bioabsorbable materials, shape memory materials, metals, noble metals, or swellable foams. In particular embodiments, the device includes nitinol. Some of the devices are formed from a single piece of material, while others are formed from multiple pieces of material joined together.
  • [0013]
    Some closure devices according to the present invention are intended to puncture septum primum upon insertion into the heart. For example, such a device may be inserted into the right atrium of the heart and puncture septum primum to enter the left atrium of the heart. At this point, the first end of the device may simply be deployed into the left atrium, or the first end of the device may be deployed into the left atrium and at least partially puncture septum secundum. In those embodiments where the first end of the device at least partially punctures septum secundum, the first end may be embedded in septum secundum or may completely puncture septum secundum such that the first end extends into the right atrium. The second end of the device may then be positioned against septum secundum in the right atrium, thereby providing a compressive force to the septal tissues. In other embodiments, the second end is also positioned in the left atrium while another portion of the device, such as a fold, is positioned in the right atrium, thereby compressing the septal tissues between the device.
  • [0014]
    Alternatively, some closure devices according to the present invention are intended to be inserted between the overlapping layers of tissue, e.g. through the PFO tunnel, to enter the left atrium. In these embodiments, the first end of the device is then deployed in the left atrium and the second end of the device is deployed in the right atrium, thereby providing a compressive force to the septal tissue. As discussed above, at least one of the ends of the device may partially puncture septum secundum.
  • [0015]
    These and other features will become readily apparent from the following detailed description wherein embodiments of the invention are shown and described by way of illustration.
  • BRIEF DESCRIPTION OF THE DRAWINGS
  • [0016]
    FIG. 1 is a diagrammatic sectional view of a Patent Foramen Ovale (PFO);
  • [0017]
    FIG. 2 is a view in side elevation of the PFO closure device with mechanical anchors of the present invention;
  • [0018]
    FIGS. 3 a, 3 b and 3 c illustrate the steps in the deployment of the PFO closure device of FIG. 2;
  • [0019]
    FIG. 4 is a view in side elevation of a second embodiment of the PFO closure device with mechanical anchors of the present invention;
  • [0020]
    FIGS. 5 a, 5 b and 5 c illustrate the steps in the deployment of the PFO closure device of FIG. 4;
  • [0021]
    FIG. 6 is a view in side elevation of a catheter and septal puncture needle used to pierce septum primum;
  • [0022]
    FIG. 7 is a view in side elevation of a needle anchor for PFO closure;
  • [0023]
    FIG. 8 is a view in side elevation of a suture and anchor used for PFO closure;
  • [0024]
    FIG. 9 is a diagram of multiple anchor placement for PFO closure;
  • [0025]
    FIGS. 10 a, 10 b and 10 c illustrate the steps in the deployment of a rivet and suture type of PFO closure device;
  • [0026]
    FIGS. 11 a, 11 b, 11 c and lid illustrate the steps in the deployment of a removable PFO closure device;
  • [0027]
    FIGS. 12 a, 12 b and 12 c illustrate the steps in the deployment of a multiple hook PFO closure device;
  • [0028]
    FIG. 13 is a view in side elevation of an alternative structure of the second embodiment of the PFO closure device with mechanical anchors of the present invention;
  • [0029]
    FIG. 14 is a view in side elevation of an alternative structure of the second embodiment of the PFO closure device with mechanical anchors of the present invention; and
  • [0030]
    FIGS. 15 a, 15 b, and 15 c are an end face view from the right atrium, an end face view from the left atrium, and a side elevation view, respectively, of the deployed alternative structure of the second embodiment of the PFO closure device with mechanical anchors of the present invention.
  • DETAILED DESCRIPTION
  • [0031]
    Referring to FIGS. 2 and 3, a PFO closure device with mechanical anchors indicated generally at 18 includes opposed grappling hook members 20 and 22 connected by a central connecting member 24. When the PFO closure device 18 is deployed, the grappling hook members 20 and 22 each include two or more curved hooks. In FIGS. 2 and 3, three curved hooks 26, 28 and 30 form the grappling hook member 20 and three curved hooks 32, 34 and 36 form the grappling hook member 22. As shown in FIG. 2, the grappling hooks 26, 28, 30, 32, 34, and 36 extend radially from the central connecting member 24. The grappling hooks of grappling hook members 20 and 22 have the same geometry but are rotated such that each grappling hook of grappling hook member 20 is situated precisely between two opposed grappling hooks of grappling hook member 22. The angle between any two grappling hooks of grappling hook members 20 and 22 may be determined by the formula 360/(number of hooks per grappling hook member). To fit within a catheter, these hooks may all be straightened outwardly and compressed to lie along the longitudinal axis of the central connecting member 24. In this form, the PFO closure device extends longitudinally within a catheter 38.
  • [0032]
    To deploy the PFO closure device 18, the catheter 38 is inserted from the right atrium 10 through the PFO tunnel, i.e. between septum primum 14 and septum secundum 16, into the left atrium 12. As shown in FIG. 3 a, the grappling hook member 20 is deployed into the left atrium. Next, as shown in FIG. 3b, the catheter 38 is drawn back into the right atrium and the grappling hooks 26, 28 and 30 are drawn back and embedded in the left sides of septum primum and septum secundum. The central connecting member 24 extends at an angle through the PFO tunnel permitting septum primum and septum secundum to be drawn to the closed position and secured by the grappling hooks 26, 28 and 30. Finally, as shown in FIG. 3 c, the catheter 38 is drawn back to permit the grappling hook member 22 to deploy, and grappling hooks 32, 34 and 36 pierce the right side of septum primum and septum secundum.
  • [0033]
    The grappling hook members 20 and 22 may be formed of flexible, spring-like, bioabsorbable polymer material so as to permit movement from the compressed straight shape to the curved hook shapes following deployment from the catheter 38. The central connecting member 24 may also be formed of bioabsorbable material, such as an absorbable suture material, so the device will ultimately leave no foreign substance in either atrium. Alternatively, the grappling hook members 20 and 22 may be formed of spring metal or of a shape memory material, such as nitinol. When the PFO closure device is not formed of bioabsorbable material, it is possible to form the device with only the grappling hook member 20 and a central connecting member 24 so that the device is repositionable and retrievable. When the device is made of a bioabsorbable material or is not intended to be retrievable, the ends of grappling hooks 26, 28, 30, 32, 34 and 36 may further include a barb to maintain the device in the septal tissue. In some embodiments, the grappling hook members 20 and 22 serve as tissue scaffolds, and are covered with a vascular material, such as polyester, biological tissue, bioresorbable polymer, or spongy polymeric material.
  • [0034]
    As shown in FIG. 3, the closure device will conform, at least to some extent, to the septal tissue that it compresses. The extent of this conformance depends upon the material from which the device was formed: a device formed of a spring metal or shape memory material will conform to the surrounding septal tissue to a lesser extent than one formed of a flexible, bioabsorbable polymer material.
  • [0035]
    FIG. 4 shows a second embodiment of a PFO closure device with mechanical anchors indicated generally at 40. This device, when deployed, forms a ring hook design that terminates in two opposed, pointed ends 42 and 44. The device may be straightened to pass through a catheter 38. To deploy the device as shown in FIGS. 5 a, 5 b and 5 c, the catheter is caused to pierce septum primum 14 and enter the left atrium where the pointed end 42 is deployed. Then, as shown in FIG. 5 b, the catheter is drawn back through septum primum to draw the device through septum primum and embed the pointed end 42 in the left side of septum secundum. Finally, as shown in FIG. 5 c, the catheter is withdrawn to fully deploy the PFO closure device and the pointed end 44 is embedded in the right side of septum secundum to compress septum primum and septum secundum together. As shown in FIGS. 4 and 5, the ring PFO closure device 40, when deployed, may include a gap that is slightly smaller than the thickness of septum secundum into which it is embedded. In some embodiments, the opposed ends 42 and 44 of the deployed PFO closure device 40 contact each other or overlap.
  • [0036]
    As shown in FIGS. 13 and 14, closure device 40 may take alternative forms. For example, closure devices 90 and 100 are formed as partial rings terminating in two pointed ends 92 and 94 or 102 and 104 and having at least one fold therebetween. Closure devices 90 and 100 are deployed in a manner similar to that described above and shown in FIG. 5. When deployed, the pointed ends 92 and 94 or 102 and 104 puncture the surface of septum secundum exposed in the left atrium and at least one of the folds contacts the surface of septum secundum exposed in the right atrium (FIGS. 15 a and 15 b). Septum primum and septum secundum are thus compressed between the pointed ends and at least one of the folds of the device (FIG. 15 c).
  • [0037]
    Multiple PFO closure devices 40, 90 or 100 can be inserted until the physician is satisfied with the resultant PFO closure. Again, the PFO closure devices may be formed of flexible, bioabsorbable polymer material, spring metal, other spring-like non-bioabsorbable material, or shape memory material. The choice of material will affect the degree to which the device conforms to the surrounding septal tissue. As shown in FIGS. 4, 13, and 14, the PFO closure device may be a monolithic structure.
  • [0038]
    A PFO may also be closed with one or more sutures. As used in the art and indicated in the Figures, “suture” refers to a single connection used to hold two pieces of material or tissue together and need not be a continuous stitch. However, to suture a PFO closed has conventionally required the attachment of septum secundum to septum primum with a continuous stitch. This need for a continuous stitch can be eliminated by implanting sutures across the PFO using implantable suture anchors. As shown in FIGS. 6 and 7, a catheter 46 is used to puncture septum primum and then septum secundum. In the case of septum primum, the puncture creates a hole through which the catheter can pass; in the case of septum secundum, the puncture may be a depression that does not pass through septum secundum. A single puncture may be made in septum secundum as shown in FIGS. 6-8, or, as subsequently described and shown in FIG. 9, multiple punctures may be made. These punctures are made using a sharp pointed needle tip 48. Following puncture to a desired depth, the catheter 46 surrounding the needle 48 is withdrawn and the needle component returns (most likely via shape memory) to its predetermined anchor-shape.
  • [0039]
    The anchors are most likely fabricated from a shape memory alloy, such as nitinol, although they could be made from a flexible, bioabsorbable polymer or a noble metal, each having their own advantage—no long term implant issues with bioabsorbable anchors and excellent radiopacity with anchors fabricated from a noble metal, such as platinum-iridium. The remainder of the suture may be formed of any suitable material, including wire, polymeric materials, and bioabsorbable materials.
  • [0040]
    The suturing method includes using a standard septal puncture technique to locate and puncture septum primum. Following this, several approaches exist. One would be that the septal puncture needle would be withdrawn from the catheter and the suturing system then delivered through the catheter (the septal needle catheter would maintain position across septum primum during the exchange). Alternatively, a wire could be placed through the septal needle catheter to maintain position and the suture system could be delivered over the wire, or the septal puncture needle could become part of the suture system. Following delivery of the suture system, the proximal end of the suture may then be tied off so as to secure the system in place and keep the PFO closed. As described below for the rivet design suture system and shown in FIG. 10 c, the proximal end of the suture may be formed into a knot, i.e. the end of the suture may be formed into a structure having a diameter larger than that of the catheter used to puncture septum primum so as to ensure that the suture system remains in place. Other suitable structures for the proximal end of the suture include, but are not limited to, coils, spirals, and other adjustable mechanisms. This structure should apply sufficient compression to hold septum primum and septum secundum together. The structure may be adjustable, such that the level of compression may be altered as necessary. Multiple sutures may be inserted until the physician is satisfied with the PFO closure.
  • [0041]
    In FIG. 8, a suture 50 is delivered through the septal needle catheter following the removal of the needle. A suture catheter 52 enters the left atrium through the septal needle catheter, is pulled back against septum secundum, setting the needle tip(s) 54 deep within it or through it, if it is thin enough. The tip could be either radiopaque, echogenic, or both, to be visible by x-ray (fluoroscopy) and/or cardiac echo. Once proper position is determined, the constricting system (a hypotube or a series of con-axial hypotubes in the embodiment where multiple needles are simultaneously delivered) is withdrawn, allowing the suture anchor 56 to form into a pre-determined shape tissue anchor, most likely via shape memory properties. The anchor 56 on the end of the suture 50 has been embedded in septum secundum and expands to anchor the suture, which passes through septum primum once the suture catheter is removed. The anchor shape can be one of many different options, including but not limited to a coil, hook, corkscrew, or grappling hook.
  • [0042]
    In those cases where a true puncture through septum secundum can be made, an anchor can be placed entirely in the right atrium, leaving nothing but suture in the left atrium. These anchors may be short strips or cylindrical rods made from a metallic or polymeric material that is biostable or bioabsorbable, or a piece of swellable foam, such as Ivalon.
  • [0043]
    In another embodiment, the septal needle catheter crosses septum secundum in multiple locations simultaneously. In this embodiment, the final result, as seen from the left atrium in an end face view of septum primum and septum secundum, would be as shown in FIG. 9, where a plurality of spaced anchors 58 engage septum secundum.
  • [0044]
    A rivet design suture system 60 is shown in FIGS. 10 a, 10 b and 10 c. Here a suture 62 and anchor 64 are contained within a catheter 66, which pierces both septum secundum and septum primum. The anchor 64, which is formed of a firm material, such as a metal disc, a small hook (such as the shape memory hooks previously described), or a piece of bio-absorbable polymer, is then deployed into the left atrium, and the suture 62 and catheter 66 are then pulled back as shown in FIG. 10 b to compress the two septa together. The suture 62 can then be knotted with knot 68, as shown in FIG. 10 c, to secure the system 60 in place to keep the PFO closed, i.e. the end of the suture may be formed into a structure having a diameter larger than that of the catheter used to puncture septum primum so as to ensure that the suture system remains in place. Other suitable structures for the second end of the suture include, but are not limited to, coils, spirals, other adjustable mechanisms. As shown in FIG. 10 c, this structure should apply sufficient compression to hold septum primum and septum secundum together. The structure may be adjustable, such that the level of compression may be altered as necessary. Multiple rivet systems can be inserted until a physician is satisfied with the PFO closure.
  • [0045]
    The PFO closure device of the present invention may be formed in a manner to facilitate removal once septum primum and septum secundum are fused. An exemplary removable PFO closure device 70 is deployed in the manner illustrated by FIGS. 11 a-11 d. The PFO closure device 70 may be delivered by a delivery catheter or sheath 72 and includes a grappling hook member 74 joined to a curved arm 76 by an enlarged tip joinder member 78. At least one of the grappling hook member and curved arm of the PFO closure device may be curved relative to the other. An elongate tether 80 is connected to the tip joinder member 78 and extends back through the catheter 72. The tether 80 can be coated to minimize trauma to the veins.
  • [0046]
    To deploy the removable PFO closure device 70 according to one embodiment of the invention, the grappling hook member 74 is passed through septum primum 14 (FIG. 11 b), and the grappling hook, when free of the catheter, curves in a manner convex relative to the surface of septum secundum and penetrates septum secundum 16 (FIG. 11 c). Then, the grappling hook is drawn back toward the catheter by the tether 80 to apply tension to the tissue causing septum secundum to be drawn into contact with septum primum. Then the curved arm 76 is deployed (FIG. 11 d) and curves in a manner concave relative to septum secundum so as to engage septum secundum as the catheter is drawn back. The compressive force applied by the grappling hook and the curved arm hold septum primum and septum secundum tightly together. The grappling hook 74 and curved arm 76 are preferably formed of shape memory material, such as nitinol, so that they respond to body temperature when deployed from the catheter 72 to form the shape shown in FIG. 11 d.
  • [0047]
    Once the PFO closure device 70 is in place, the catheter 72 is withdrawn and the free end of the tether 80 is attached to a button subcutaneously and allowed to remain in place for a period of time sufficient to allow the two septa to fuse together. Then the device is pulled through septum primum and into a recovery sheath by means of the tether 80 and removed.
  • [0048]
    The PFO closure device 70 can be deployed as shown in FIG. 11 without the tether 80 to provide a free standing device with the grappling hook 74 and arm 76 being formed to press the two septa 14 and 16 together. The device may later be removed by a removal device, which grabs the joinder member 78 and draws the device through septum primum 14 and into a removal sheath.
  • [0049]
    Instead of a single opposed grappling hook 74 and curved arm 76, the PFO closure device can include a plurality of opposed grappling hooks and curved arms radially extending in a spaced relationship from the joinder member 78. Such a device 82 is shown in FIG. 12. Here, the PFO closure device includes a plurality of grappling hooks 84 and a plurality of opposed curved arms 86 which are enclosed in a delivery catheter 72. A small hole 88 is created in septum primum 14 to permit insertion of the catheter into the left atrium and the grappling hooks 84 are deployed as shown in FIG. 12 a. Then, the delivery catheter is drawn back to engage the hooks with both septum secundum and septum primum as shown in FIG. 12 b. Next, as shown in FIG. 12 c, the catheter is drawn away to release the curved arms 86, which engage the two septa in opposed relationship to the grappling hooks 84. The device may have many, e.g. eight, opposed grappling hooks and curved arms. As in the case of the PFO closure device 70, the device 82 may be removed by grasping the tip joinder member 78.
  • [0050]
    The device 82 may be permanently deployed by inserting the catheter through the PFO channel between septum secundum and septum primum into the left atrium to deploy the grappling hooks 84. Then, the catheter is withdrawn back through the PFO channel to release the curved arms 86.
  • [0051]
    Having described embodiments of the present invention, it should be apparent that the invention is capable of other and different embodiments and may be modified in various respects, all without departing from the scope of the invention as defined by the appended claims. Accordingly, the foregoing drawings and description are to be regarded as illustrative in nature and not in a restrictive or limiting sense.
Patent Citations
Cited PatentFiling datePublication dateApplicantTitle
US3874388 *12 Feb 19731 Apr 1975Ochsner Med Found AltonShunt defect closure system
US3875648 *4 Apr 19738 Apr 1975Dennison Mfg CoFastener attachment apparatus and method
US4006747 *23 Apr 19758 Feb 1977Ethicon, Inc.Surgical method
US4007743 *20 Oct 197515 Feb 1977American Hospital Supply CorporationOpening mechanism for umbrella-like intravascular shunt defect closure device
US4149327 *11 Jul 197717 Apr 1979Jura Elektroapparate-Fabriken L. Henzirohs A.G.Steam iron
US4425908 *22 Oct 198117 Jan 1984Beth Israel HospitalBlood clot filter
US4738666 *28 Jan 198719 Apr 1988Genus Catheter Technologies, Inc.Variable diameter catheter
US4802478 *31 Aug 19847 Feb 1989Minnesota Mining And Manufacturing CompanyMedical staple and removal method
US4902508 *11 Jul 198820 Feb 1990Purdue Research FoundationTissue graft composition
US4915107 *27 Feb 198910 Apr 1990Harley International Medical Ltd.Automatic instrument for purse-string sutures for surgical use
US4917089 *29 Aug 198817 Apr 1990Sideris Eleftherios BButtoned device for the transvenous occlusion of intracardiac defects
US5078736 *4 May 19907 Jan 1992Interventional Thermodynamics, Inc.Method and apparatus for maintaining patency in the body passages
US5106913 *16 Mar 199021 Apr 1992Sumitomo Chemical Company, LimitedRubber composition
US5108420 *1 Feb 199128 Apr 1992Temple UniversityAperture occlusion device
US5176659 *28 Feb 19915 Jan 1993Mario ManciniExpandable intravenous catheter and method of using
US5192301 *3 Sep 19919 Mar 1993Nippon Zeon Co., Ltd.Closing plug of a defect for medical use and a closing plug device utilizing it
US5275826 *13 Nov 19924 Jan 1994Purdue Research FoundationFluidized intestinal submucosa and its use as an injectable tissue graft
US5282827 *5 Mar 19921 Feb 1994Kensey Nash CorporationHemostatic puncture closure system and method of use
US5284488 *23 Dec 19928 Feb 1994Sideris Eleftherios BAdjustable devices for the occlusion of cardiac defects
US5304184 *19 Oct 199219 Apr 1994Indiana University FoundationApparatus and method for positive closure of an internal tissue membrane opening
US5486193 *1 May 199523 Jan 1996C. R. Bard, Inc.System for the percutaneous transluminal front-end loading delivery of a prosthetic occluder
US5507811 *15 Nov 199416 Apr 1996Nissho CorporationProsthetic device for atrial septal defect repair
US5601571 *22 May 199511 Feb 1997Moss; GeraldSurgical fastener implantation device
US5603703 *28 Apr 199518 Feb 1997Medtronic, Inc.Selectively aspirating stylet
US5618311 *28 Sep 19948 Apr 1997Gryskiewicz; Joseph M.Surgical subcuticular fastener system
US5620461 *5 Jan 199515 Apr 1997Muijs Van De Moer; Wouter M.Sealing device
US5649977 *22 Sep 199422 Jul 1997Advanced Cardiovascular Systems, Inc.Metal reinforced polymer stent
US5709707 *19 Nov 199620 Jan 1998Children's Medical Center CorporationSelf-centering umbrella-type septal closure device
US5713864 *11 Apr 19953 Feb 1998Sims Level 1, Inc.Integral conductive polymer resistance heated tubing
US5717259 *11 Jan 199610 Feb 1998Schexnayder; J. RodneyElectromagnetic machine
US5720754 *28 Apr 199524 Feb 1998Medtronic, Inc.Device or apparatus for manipulating matter
US5725552 *14 May 199610 Mar 1998Aga Medical CorporationPercutaneous catheter directed intravascular occlusion devices
US5733294 *28 Feb 199631 Mar 1998B. Braun Medical, Inc.Self expanding cardiovascular occlusion device, method of using and method of making the same
US5733337 *7 Apr 199531 Mar 1998Organogenesis, Inc.Tissue repair fabric
US5741297 *28 Aug 199621 Apr 1998Simon; MorrisDaisy occluder and method for septal defect repair
US5855614 *7 May 19965 Jan 1999Heartport, Inc.Method and apparatus for thoracoscopic intracardiac procedures
US5861003 *23 Oct 199619 Jan 1999The Cleveland Clinic FoundationApparatus and method for occluding a defect or aperture within body surface
US5865791 *23 Jun 19972 Feb 1999E.P. Technologies Inc.Atrial appendage stasis reduction procedure and devices
US5879366 *20 Dec 19969 Mar 1999W.L. Gore & Associates, Inc.Self-expanding defect closure device and method of making and using
US5893856 *12 Jun 199613 Apr 1999Mitek Surgical Products, Inc.Apparatus and method for binding a first layer of material to a second layer of material
US6010517 *8 Apr 19974 Jan 2000Baccaro; Jorge AlbertoDevice for occluding abnormal vessel communications
US6019753 *9 Nov 19981 Feb 2000Smiths Industries Public Limited CompanyCatheter assemblies and inner cannulae
US6024756 *22 Dec 199815 Feb 2000Scimed Life Systems, Inc.Method of reversibly closing a septal defect
US6027519 *9 Dec 199822 Feb 2000Stanford; Ulf HarryCatheter with expandable multiband segment
US6030007 *7 Jul 199729 Feb 2000Hughes Electronics CorporationContinually adjustable nonreturn knot
US6168588 *22 Sep 19992 Jan 2001Medi-Dyne Inc.Overlapping welds for catheter constructions
US6171329 *28 Aug 19989 Jan 2001Gore Enterprise Holdings, Inc.Self-expanding defect closure device and method of making and using
US6174322 *31 Jul 199816 Jan 2001Cardia, Inc.Occlusion device for the closure of a physical anomaly such as a vascular aperture or an aperture in a septum
US6174330 *1 Aug 199716 Jan 2001Schneider (Usa) IncBioabsorbable marker having radiopaque constituents
US6183443 *26 Oct 19986 Feb 2001Scimed Life Systems, Inc.Expandable introducer sheath
US6187039 *10 Dec 199713 Feb 2001Purdue Research FoundationTubular submucosal graft constructs
US6190353 *11 Oct 199620 Feb 2001Transvascular, Inc.Methods and apparatus for bypassing arterial obstructions and/or performing other transvascular procedures
US6190357 *21 Apr 199820 Feb 2001Cardiothoracic Systems, Inc.Expandable cannula for performing cardiopulmonary bypass and method for using same
US6199262 *26 Feb 199913 Mar 2001Medtronic, Inc.Method of making a guiding catheter
US6206895 *6 Oct 199927 Mar 2001Scion Cardio-Vascular, Inc.Suture with toggle and delivery system
US6206907 *7 May 199927 Mar 2001Cardia, Inc.Occlusion device with stranded wire support arms
US6214029 *26 Apr 200010 Apr 2001Microvena CorporationSeptal defect occluder
US6217590 *15 Jul 199917 Apr 2001Scion International, Inc.Surgical instrument for applying multiple staples and cutting blood vessels and organic structures and method therefor
US6221092 *30 Mar 199924 Apr 2001Nissho CorporationClosure device for transcatheter operations and catheter assembly therefor
US6334872 *7 Jul 19971 Jan 2002Organogenesis Inc.Method for treating diseased or damaged organs
US6342064 *22 Dec 199929 Jan 2002Nipro CorporationClosure device for transcatheter operation and catheter assembly therefor
US6344048 *28 Apr 19995 Feb 2002Scimed Life Systems, Inc.Removable occlusion system for aneurysm neck
US6344049 *12 Sep 20005 Feb 2002Scion Cardio-Vascular, Inc.Filter for embolic material mounted on expandable frame and associated deployment system
US6346074 *12 Jun 199612 Feb 2002Heartport, Inc.Devices for less invasive intracardiac interventions
US6348041 *29 Mar 200019 Feb 2002Cook IncorporatedGuidewire
US6352552 *2 May 20005 Mar 2002Scion Cardio-Vascular, Inc.Stent
US6355052 *4 Feb 199712 Mar 2002Pfm Produkte Fur Die Medizin AktiengesellschaftDevice for closure of body defect openings
US6356782 *2 Apr 199912 Mar 2002Vivant Medical, Inc.Subcutaneous cavity marking device and method
US6358238 *2 Sep 199919 Mar 2002Scimed Life Systems, Inc.Expandable micro-catheter
US6508828 *3 Nov 200021 Jan 2003Radi Medical Systems AbSealing device and wound closure device
US6514515 *3 Mar 20004 Feb 2003Tepha, Inc.Bioabsorbable, biocompatible polymers for tissue engineering
US6689589 *9 Nov 200110 Feb 2004Metabolix, Inc.Biological systems for manufacture of polyhydroxyalkanoate polymers containing 4-hydroxyacids
US6712804 *13 Jul 200130 Mar 2004Ev3 Sunnyvale, Inc.Method of closing an opening in a wall of the heart
US6712836 *12 May 200030 Mar 2004St. Jude Medical Atg, Inc.Apparatus and methods for closing septal defects and occluding blood flow
US6838493 *26 Feb 20024 Jan 2005Metabolix, Inc.Medical devices and applications of polyhydroxyalkanoate polymers
US6867247 *1 May 200215 Mar 2005Metabolix, Inc.Medical devices and applications of polyhydroxyalkanoate polymers
US6867248 *28 Mar 200315 Mar 2005Metabolix, Inc.Polyhydroxyalkanoate compositions having controlled degradation rates
US6867249 *12 Dec 200215 Mar 2005Kin Man Amazon LeeLightweight and porous construction materials containing rubber
US20020010481 *20 Dec 200024 Jan 2002Swaminathan JayaramanOcclusive coil manufacture and delivery
US20020019648 *18 Apr 200114 Feb 2002Dan AkerfeldtIntra-arterial occluder
US20020022859 *26 Jul 200121 Feb 2002Michael HogendijkCatheter having radially expandable main body
US20020022860 *17 Aug 200121 Feb 2002Borillo Thomas E.Expandable implant devices for filtering blood flow from atrial appendages
US20020026208 *7 Dec 200028 Feb 2002Medical Technology Group, Inc.Apparatus and methods for delivering a closure device
US20020029048 *31 Aug 20017 Mar 2002Arnold MillerEndovascular fastener and grafting apparatus and method
US20020032459 *21 Nov 200114 Mar 2002Danforth Biomedical, Inc.Radially-expandable tubular elements for use in the construction of medical devices
US20020032462 *10 Jun 199914 Mar 2002Russell A. HouserThermal securing anastomosis systems
US20020034259 *5 Feb 200121 Mar 2002Katsuyuki TadaTransmitter for automatically changing transmission data type within specified band
US20020035374 *21 Sep 200121 Mar 2002Borillo Thomas E.Apparatus for implanting devices in atrial appendages
US20030004533 *6 May 20022 Jan 2003Concentric MedicalBioactive polymer vaso-occlusive device
US20030023266 *19 Jul 200230 Jan 2003Borillo Thomas E.Individually customized atrial appendage implant device
US20030028213 *30 Jul 20026 Feb 2003Microvena CorporationTissue opening occluder
US20030045893 *6 Sep 20016 Mar 2003Integrated Vascular Systems, Inc.Clip apparatus for closing septal defects and methods of use
US20030050665 *7 Sep 200113 Mar 2003Integrated Vascular Systems, Inc.Needle apparatus for closing septal defects and methods for using such apparatus
US20030055455 *20 Sep 200120 Mar 2003Scimed Life Systems, Inc.Method and apparatus for treating septal defects
US20030057156 *8 Mar 200227 Mar 2003Dean PetersonAtrial filter implants
US20030059640 *2 Aug 200227 Mar 2003Denes MartonHigh strength vacuum deposited nitinol alloy films and method of making same
US20040044361 *28 Apr 20034 Mar 2004Frazier Andrew G.C.Detachable atrial appendage occlusion balloon
US20050025809 *8 Jul 20043 Feb 2005Tepha, Inc.Poly-4-hydroxybutyrate matrices for sustained drug delivery
US20050043759 *14 Jul 200424 Feb 2005Nmt Medical, Inc.Tubular patent foramen ovale (PFO) closure device with catch system
US20070010851 *31 Mar 200611 Jan 2007Chanduszko Andrzej JTubular patent foramen ovale (PFO) closure device with catch system
WO2000007506A2 *3 Aug 199917 Feb 2000Anson Medical Ltd.Devices and methods for the repair of arteries
Referenced by
Citing PatentFiling datePublication dateApplicantTitle
US802953416 Mar 20094 Oct 2011Cook Medical Technologies LlcClosure device with string retractable umbrella
US827748230 Aug 20112 Oct 2012Cook Medical Technologies LlcClosure device with string retractable umbrella and method for closing a body opening with the same
US836993016 Jun 20105 Feb 2013MRI Interventions, Inc.MRI-guided devices and MRI-guided interventional systems that can track and generate dynamic visualizations of the devices in near real time
US839653216 Jun 201012 Mar 2013MRI Interventions, Inc.MRI-guided devices and MRI-guided interventional systems that can track and generate dynamic visualizations of the devices in near real time
US876843321 Dec 20121 Jul 2014MRI Interventions, Inc.MRI-guided devices and MRI-guided interventional systems that can track and generate dynamic visualizations of the devices in near real time
US882513324 Jan 20132 Sep 2014MRI Interventions, Inc.MRI-guided catheters
US888628810 Jan 201311 Nov 2014MRI Interventions, Inc.MRI-guided devices and MRI-guided interventional systems that can track and generate dynamic visualizations of the devices in near real time
US92592908 Jun 201016 Feb 2016MRI Interventions, Inc.MRI-guided surgical systems with proximity alerts
US93752187 Oct 201328 Jun 2016Datascope Corp.Systems and methods of tissue closure
US94397358 Jun 201013 Sep 2016MRI Interventions, Inc.MRI-guided interventional systems that can track and generate dynamic visualizations of flexible intrabody devices in near real time
US20100234878 *16 Mar 200916 Sep 2010Cook IncorporatedClosure device with string retractable umbrella
Classifications
U.S. Classification606/151
International ClassificationA61B17/08, A61B17/00, A61F2/02, A61B, A61B17/068, A61B17/064
Cooperative ClassificationA61B2017/00579, A61B2017/00592, A61B2017/00867, A61B17/0644, A61B2017/00615, A61B2017/00575, A61B17/068, A61B17/0057
European ClassificationA61B17/064D, A61B17/00P
Legal Events
DateCodeEventDescription
20 Jun 2011ASAssignment
Owner name: W.L. GORE & ASSOCIATES, INC., ARIZONA
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:NMT MEDICAL, INC. (BY AND THROUGH JOSEPH F. FINN, JR., ASASSIGNEE FOR THE BENEFIT OF CREDITORS OF NMT MEDICAL, INC.);REEL/FRAME:026503/0273
Effective date: 20110616