Patent Grant
8795329
The invention generally relates to devices and related methods for treating intracardiac defects. More particularly the invention relates to devices for treating intracardiac defects with an energy source.
The human heart is divided into four compartments or chambers. The left and right atria are located in the upper portion of the heart and the left and right ventricles are located in the lower portion of the heart. The left and right atria are separated from each other by a muscular wall, the intra-atrial septum, while the ventricles are separated by the intraventricular septum.
Either congenitally or by acquisition, abnormal openings, holes, or shunts can occur between the chambers of the heart or the great vessels, causing blood to flow therethrough. Such deformities are usually congenital and originate during fetal life when the heart forms from a folded tube into a four chambered, two unit system. The deformities result from the incomplete formation of the septum, or muscular wall, between the chambers of the heart and can cause significant problems. Ultimately, the deformities add strain on the heart, which may result in heart failure if they are not corrected.
One such deformity or defect, a patent foramen ovale, is a persistent, one-way, usually flap-like opening in the wall between the right atrium and left atrium of the heart. Since left atrial pressure is normally higher than right atrial pressure, the flap typically stays closed. Under certain conditions, however, right atrial pressure exceeds left atrial pressure, creating the possibility for right to left shunting that can allow blood clots to enter the systemic circulation. This is particularly worrisome to patients who are prone to forming venous thrombus, such as those with deep vein thrombosis or clotting abnormalities.
Nonsurgical (i.e., percutaneous) closure of a patent foramen ovale, as well as similar intracardiac defects such as an atrial septal defect, a ventricular septal defect, and ablation of the left atrial appendage, is possible using a variety of mechanical closure devices that are implanted into the anatomical site requiring treatment.
However, there are potential drawbacks to using a mechanical closure alone for the treatment of intracardiac defect. For example, some mechanical closures are prone to weakening and breakage. In addition, poor tissue ingrowth or improper positioning of the mechanical closure may lead to continued shunting of blood across the defect. Therefore, given the potential disadvantages of mechanical closures, there is a need in the art for correcting intracardiac defects by utilizing alternate methods. For example, tissue welding may be useful in correcting such defects. Tissue welding, a procedure wherein energy is applied to tissues to join them has been used to correct defects in the arteries, veins, bowel and nerves. Therefore, there is a need in the art for devices applying this technology to correct intracardiac defects.
The present invention provides systems and methods for treating an intracardiac defect through the delivery of energy. In one aspect, the system includes a device for delivering an energy delivery element to the site of the intracardiac defect. The energy delivery element delivers energy to the intracardiac defect. After delivery of energy, the energy delivery element is either left in place or removed from the site and the intracardiac defect is allowed to heal.
In one embodiment, the invention includes a removable device for occluding a patent foramen ovale (PFO). The removable device includes a sheath having a lumen, a proximal end and a distal end; an elongated member; and an energy delivery element. One of the sheath and the elongated member is axially movable relative to the other. The energy delivery element includes at least one coil having an electrode for delivering RF energy. The at least one coil includes at least a first loop and a second loop wherein the first loop has a diameter differing from the second loop. The energy delivery element is coupled to the elongated member to facilitate deployment and removal of said energy delivery element at the PFO. The energy delivery element is also operatively joined to an energy source.
In another embodiment, the invention includes a device for occluding a patent foramen ovale in patient including a sheath, an elongated member and an energy delivery element. The sheath includes a lumen, and at least one of the sheath and the elongated member is axially moveable relative to the other. The energy delivery element includes a first braided portion and a second braided portion separated by a non-braided portion. The energy delivery element is coupled to the elongated member to facilitate deployment and removal of the energy delivery element at the PFO.
In a further embodiment, the invention includes a medical device for occluding the tunnel of a patent foramen ovale in a patient including a sheath, an elongated member, and an energy delivery element including a plug. The sheath includes a lumen and one of the sheath and the elongated member is axially moveable relative to the other. The plug includes animal tissue and is joined to the elongated member. The plug also includes a core member sized and shaped to substantially fill the tunnel of the PFO.
In yet another embodiment, the invention includes a removable device for occluding a patent foramen ovale including a sheath, an elongated member and an energy delivery element. The sheath includes a lumen and one of the sheath and the elongated member is axially moveable relative to the other. The energy delivery element is coupled to the elongate member to facilitate deployment and removal of the energy delivery element at the PFO. The energy delivery element includes at least one curvilinear member with a releasable coating for bonding to the tissues of the PFO.
In another aspect, the invention provides a method for occluding a PFO using energy. For example, in one embodiment, a method for occluding a PFO includes passing a device through a PFO tunnel into a left atrium of a patient's heart. The device includes a sheath having a proximal end, a distal end, and a lumen; an elongated member; an energy delivering element including an occlusion shell; and an attachment device for attaching the elongated member to the energy delivery element. The elongated member and the sheath are axially moveable relative to the other. The energy delivery element includes an occluding member having at least one occlusion shell. The occluding member is deployed on the left atrial side of the PFO by retracting the sheath. Energy is applied to the PFO via the energy delivery element. The occluder is detached from the elongated member and the elongated member is then removed from the PFO.
In the drawings, like reference characters generally refer to the same part throughout the different views. Also, the drawings are not necessarily to scale, emphasis instead generally being placed upon illustrating the principles of the invention.
The present invention relates to a system for the repair of intracardiac defects, such as, for example, a patent foramen ovale, an atrial septal defect, a ventricular septal defect, and for obliteration of a left atrial appendage. The invention includes a system capable of delivering energy to an intracardiac defect, such as a patent foramen ovale. An energy delivery element is placed at the location of the intracardiac defect by a delivery catheter, and once appropriately positioned, the energy delivery element delivers energy from an energy source that welds tissues of the defect together, occluding any openings. The term “weld” as it is used throughout this application means sealing together either completely or substantially. The energy delivery element can be removed in its entirety after delivery of energy or alternatively, a portion or portions of the energy delivery element can be permanently implanted in the area of the defect after delivery of energy. Welding of the tissues can occur after the energy delivery element is removed, or while the energy delivery element is positioned in the intracardiac defect.
Delivery System
In another embodiment, the system 18 further includes an energy source 26. The energy source 26 can provide one or more of any number of energy types including, but not limited to microwave energy, infrared energy, visible light waves, ultraviolet rays, x-rays, gamma rays, cosmic rays, acoustic energy, thermal energy, or radio frequency energy. In a preferred embodiment, the energy source 26 provides radio frequency energy (RF) for the system 18. For example, the energy source 26 is connected directly to the energy delivery element 22, in one embodiment, while in another embodiment, it is connected to the delivery catheter 28 or a component of the delivery catheter 28 to which the energy delivery element 22 is connected. Alternate modes of coupling the energy source 26 to the energy delivery element 22 will be obvious to one of skill in the art and are within the scope of the invention.
Referring again to
With continued reference to
In one embodiment, the energy delivery element 22 is permanently connected to the cable 24 at the distal end 21 of the energy delivery element 22. For example, the distal end of the cable 24 is connected to the distal end 21 of the energy delivery element 22. In another embodiment, the energy delivery element 22 is permanently connected to the cable 24 at the proximal end 34 of the energy delivery element 22. For example, the distal end of the cable 24 is connected to the proximal end 34 of the energy delivery element 22.
In another embodiment, the energy delivery element 22 is releasably connected to the cable 24 at the proximal end 34 of the energy delivery element 22 by a releasable attachment (not shown), while in another embodiment, the energy delivery element 22 is releasably connected to the cable 24 at the distal end 21 of the energy delivery element 22 by a releasable attachment (not shown). Examples of releasable attachments suitable for connecting the energy delivery element 22 to the cable 24 include, but are not limited to, for example, ball-rod connections, ball-claw connections, threaded connections, looped connections, magnetic connections, male-female connections, adhesive connections, clamped connections, and hook-eye connections.
Referring still to
In a further embodiment, the energy delivery element 22 is releasably connected to the cable 24 and the releasable attachment point 36 is insulated. For example, in one embodiment a non-conductive insulating material is provided in the form of a coating, a temporary sleeve, a permanent sleeve, or an extrusion on or surrounding the releasable attachment 36 at and/or around the connection point 36. Likewise, other portions of the system 18 that contact the blood should be appropriately insulated with a non-conductive material. Those portions of the system 18 that are insulated can be insulated by a temporary or permanent non-conductive coating or sleeve. Examples of non-conductive materials that may be used for these purposes include one or more polymers.
With continued reference to
The delivery sheath 20 is attached to a wire or cable or rod (not shown) to permit movement of the delivery sheath in the proximal 30 and distal 32 directions. For example, in one embodiment the proximal end of the delivery sheath 20 is attached to a wire or cable or rod (not shown) that is coaxial with or parallel to cable 24. In another embodiment, the distal end 30 of the delivery sheath 20 is attached to a wire or cable or rod coaxial with or parallel to cable 24. In one embodiment, the wire, cable or rod attached to the delivery sheath 20 is operatively connected to an actuating member (not shown). An operator moves the sheath 20 proximally or distally by moving the actuating member proximally or distally, respectively, according to one embodiment of the invention.
In order to deploy the energy delivery element 22 positioned inside the lumen 16 of catheter 28, in one embodiment, an operator positions the distal end 30 of the delivery catheter 28 appropriately in the intracardiac defect 14, and then retracts the delivery catheter 28 proximally, deploying the energy delivery element 22 at the site of an intracardiac defect 14. In an alternate embodiment, the operator advances the cable 24 beyond the distal end 30 of the delivery sheath 20, and deploys the energy delivery element 22. Optionally, the energy delivery element 22 may be recaptured by the sheath 20 and removed after delivery of energy to the intracardiac defect 14. In another embodiment, the energy delivery element 22 may be recaptured by the delivery catheter 28. Optionally, if the energy delivery element 22 is permanently placed in the intracardiac defect 14, the energy delivery element 22 is released from the cable 24 by releasing the releasable attachment 36 at the attachment point after delivery of energy to the intracardiac defect 14. While the aforementioned embodiments of the delivery system 18 are useful for delivering the energy delivery element 22 to an intracardiac defect, any suitable delivery system known to one of skill in the art may be utilized.
Energy Delivery Element
A coil 47, according to the invention, comprises at least one loop 21, but may comprise a plurality of loops. A loop 21 is a full turn of the coil 47. For example, in one embodiment, the coil 47 of the energy delivery element 22 comprises at least one spiral loop 21, i.e., a full turn of a continuous curve traced by a point moving around a fixed point in the same plane while steadily increasing or diminishing its distance from the fixed point (like a watch spring). In another embodiment, the coil 47 of the energy delivery element 22 comprises at least one helical loop 21, i.e., a full turn of a continuous curve traced by a point moving around a fixed point along an axis (like a cork screw). The diameter of the helical loops 21 of the coil 47, may increase, decrease or stay the same along the axis of the coil 47. In another embodiment, the energy delivery element 22 has two loops, while in a further embodiment, the energy delivery element 22 has 3, 4, 5, 6, 7, 8, 9, 10 or more loops. In addition, the coil 47 is a right hand coil in one embodiment, while it is a left hand coil in a second embodiment. In a further embodiment, the coil 47 contains at least one right-handed loop 21 and at least one left-handed loop 21.
With continued reference to
In one embodiment, the central post 29 is releasably joined to the coil 47 at either one or both of the proximal end 9 and distal end 5 of the central post 29 by a releasable attachment (not shown).
With continued reference to
In order to deploy the energy delivery element 22, the energy delivery element 22 must be released from the confines of the delivery catheter 28. In one embodiment, for example, the delivery catheter 28 is retracted proximally to expose the energy delivery element 22. In another embodiment, the energy delivery element 22 is advanced beyond the distal end 30 of the catheter 28 to deploy the energy delivery element 22. In another embodiment, the operator retracts the catheter 28 and any delivery sheath (not shown) to reveal the central post 29 and coil 47 of the energy delivery element 22.
To deploy the energy delivery element 22, in one embodiment the operator moves the push rod 33 distally causing the loops 21 of the energy delivery element 22 expand at the intracardiac defect 14. In an alternative embodiment, the push rod 33 remains stationary while the operator retracts the central post 29 proximally, also causing the loops 21 of the energy delivery element 22 to expand. For example, in one embodiment, in a deployed state, at least one loop 21 of the coil 47 of the energy delivery element 22 has a diameter that is larger than the diameter of the at least one loop 21 in an undeployed state. In yet another embodiment, in a deployed state the length of the axis of coil 47 from the proximal end 27 to the distal end 25 is decreased as compared to the length of the axis of the coil 47 in an undeployed state.
In one embodiment, the loops 21 of the energy delivery element 22 are deployed in the left atrium 6 and right atrium 12. In another embodiment, the loops 21 of the energy delivery element 22 are deployed only in the left atrium 6.
After energy is delivered to the patent foramen ovale 14, including the septum primum 8, the septum secundum 10, or both, in one embodiment, the operator moves the push rod 33 proximally to collapse the loops 21 of the of the energy delivery element 22 to their original size, for removal from the intracardiac defect 23. In an alternate embodiment, the operator moves the central post 29 distally while keeping the push rod 33 stationary to collapse the loops 21 of the energy delivery element 22.
With continued reference to
In a further embodiment, the system 18 includes a pull wire (not shown) and a push rod 33. The push rod 33, in one embodiment, is coaxial with the pull wire, while in another embodiment, the push rod 33 is parallel with the pull wire. In a further embodiment, the push rod 33 is attached to the proximal end of the energy delivery element 22 while the pull wire is attached to the distal end of the energy delivery element.
To deploy the energy delivery element 22, in one embodiment the operator retracts the pull wire proximally causing the loops 21 of the energy delivery element 22 to expand at the intracardiac defect 14. In another embodiment, the operator moves the push rod 33 distally and the pull wire proximally causing the loops 21 of the energy delivery element 22 to expand at the intracardiac defect 14. In a further embodiment, the operator twists the push rod 33 to the right or to the left (depending on whether the coil 47 has right hand or left hand loops, respectively) while moving the push rod 33 distally along the cable 24, to improve the extension of the loops 21 of the energy delivery element 22, i.e., to increase the diameter of the loops 21 of the coil 47. In yet another embodiment, the operator twists the push rod 33 while moving the push rod 33 distally and twists the pull wire as it moves proximally along the cable 24 to improve the extension of the loops 21.
After energy is delivered to the patent foramen ovale 14, including the septum primum 8, the septum secundum 10, or both, in one embodiment, the operator moves the push rod 33 proximally, and if necessary, moves the central post 29 distally to collapse the loops 21 of the energy delivering elements 22 to their original size, for removal from the intracardiac defect 23.
After energy is delivered to the patent foramen ovale 14, including the septum primum 8, the septum secundum 10, or both, according to one embodiment, the operator moves the pull wire distally to elongate the loops 21 to their original size prior to deployment. In another embodiment, the operator moves the push rod 33 proximally and the pull wire distally to elongate the loops 21 of the of the energy delivering element 22 to their original size, for removal from the intracardiac defect 23.
According to an illustrative embodiment of the invention,
For example, in on embodiment, deploying the energy delivery element 22 includes the step of removing the energy delivery element 22 from the confines of the delivery sheath 20. In one embodiment, for example, the sheath 20 is retracted proximally to expose the energy delivery element 22, while in another embodiment, the energy delivery element 22 is advanced distally beyond the distal end 30 of the sheath 20.
In another embodiment, deployment of the energy delivery element 22 includes the step of disconnecting the proximal end of coil 47 of the energy delivery element 22 from the attachment point 36, causing the loop or loops 21 to unfurl and expand on both the left atrial 6 and right atrial 12 sides of the patent foramen ovale 14. Once deployed, the loops 21 on both the left atrial 6 and right atrial 12 sides of the tunnel 23 of the patent foramen ovale 14 appose the septum secundum 10 and the septum primum 8 allowing them to weld to one another upon application of energy to this anatomical site through the energy delivery element 22 as shown in
Alternately, in another embodiment, the loops 21 of the energy delivery element 22 are deployed only on the left atrial side 6 of the patent foramen ovale 14. With the energy delivery element 22 deployed at the patent foramen ovale 14, energy is applied through the energy delivery element 22 to the septum primum 8 and septum secundum 10. The energy delivery element 22 is optionally removed by retracting the cable 24. The cable 24 is attached to the distal end of the central post 29. The central post 29 remains attached to energy delivery element 22 at least the distal end point 25.
As shown in
Referring now to
Referring to
With continued reference to
In a further embodiment, the proximal end of the proximal coil 47a connects at connection point 36 to a push rod 33 which optionally twists axially, while the distal end of the distal coil 47b connects at connection point 36′ to a pull back wire or rod 43 which also optionally twists axially. In one embodiment, the connection 36 between the push rod 33 and the proximal coil 47a is fixed, while in another embodiment the connection 36 is releasable. For example, in one embodiment, the push rod 33 engages a ball on the proximal end 27 of coil 47a to allow the push rod 33 to actuate movement of the coil 47a. In another embodiment, the connection 36′ between the distal coil 47b and the pull back rod or wire 43 is fixed, while in another embodiment, the connection 36′ is releasable. For example, in one embodiment, the pull back rod or wire 43 engages a ball on the distal end of coil 47b to actuate movement of the coil 47b.
In one embodiment, the push rod 33 and pull back rod 43 are parallel to one another. In another embodiment, the push rod 33 and pull rod 43 are coaxial with one another. In a further embodiment, the push rod 33 and pull back rod 43 are parallel to the cable 24, and may alternatively be coaxial with the cable 24. According to one embodiment of the invention, movement of the push rod 33 distally elongates and deploys the loops 21 of the proximal coil 47a, while movement of the pull wire proximally 27 elongates and deploys the loops 21 of the distal coil 47b. For example, in one embodiment, at least one loop 21 of each of coil 47a and 47b has a first smaller diameter prior to deployment and a second larger diameter after deployment.
With continued reference to
With reference to
Prior to deployment, the loops 21 of the energy delivery element 22 are maintained in a collapsed state inside the delivery catheter 28. To deploy the energy delivery element 22, the operator introduces the delivery catheter 28 into the left atrium 6 through the tunnel 23 of the patent foramen ovale 14 and deploys the locator 40. In one embodiment, the operator deploys the locator on the left atrial side 6 by retracting the delivery catheter 28, and if necessary, any delivery sheath 20 enclosing the locator 40. In another embodiment, the operator deploys the locator 40 by pushing the locator 40 portion of the energy delivery element 22 distally beyond the distal end of the delivery catheter 28 and if necessary, any portion of a delivery sheath 20 housing the locator 40. The remaining loops 21 of the energy delivery element 22 not comprising the locator remain inside the delivery catheter 28 in a collapsed state until their subsequent deployment.
To deploy loops 21 not comprising the locator 40, the operator moves the delivery catheter proximally so that the locator 40 abuts the septal wall of the left atrium 12. Next, the operator then retracts the delivery catheter 28 and any delivery sheath 20 housing the loops 21 to expose the remaining loops 21 in the tunnel 23. In an alternate embodiment, the locator 40 and the loops 21 of the energy delivery element 22 are exposed in the left atrium 6 and then moved into the tunnel 23 after deployment.
The locator 40 of the energy delivery element 22 apposes the septum primum 8 and septum secundum 10 to improve closure of the defect 14 by abutting the left atrial septal wall. After the locator 40 and loops 21 of the energy delivery element 22 are appropriately positioned, energy is delivered to the defect. In one embodiment the locator 40 is insulated, while in another embodiment, the locator 40 transfers energy to the septum primum 8 and septum secundum 10. Once energy has been delivered, the energy delivery element 22 is recaptured by the delivery catheter 28 and removed from the patent foramen ovale 14. The septum primum 8 and septum secundum 10 then weld together.
While
In one embodiment, the implant 50 is an adhesive member, e.g., a plug of adhesive that adheres to septum primum 8 and septum secundum 10 to improve tissue apposition and closure of the patent foramen ovale 14. In another embodiment, the implant 50 includes one or more of a polymer, a bioabsorbable material, a growth stimulating material, or a metal with a low melting point. In a further embodiment, the implant 50 includes an animal tissue, for example, such as intestinal submucosa, urinary bladder basement membrane or collagen. According to the invention, an implant coating or sleeve 50 as described herein can be placed on any of the embodiments of energy delivery elements 22 described in this application.
The implant 50, according to one embodiment, adheres to the septum primum 8 and septum secundum 10 and is released from the energy delivery element 22 when the energy delivery element 22 is retracted after energy is applied to the intracardiac defect 14. In one embodiment, the plug is sized and shaped to substantially fill the patent foramen ovale 14. According to one embodiment, the implant 50 expands to fill the patent foramen ovale 14 upon application of energy.
With continued reference to
In order to deploy the energy delivery element 22, for example, shown in
As shown in
In order to deploy the energy delivery element 22, an operator introduces the delivery catheter 28 into the left atrium 6 and retracts the delivery catheter proximally to allow coil 47a of the first energy delivery element 22 to deploy in the left atrium 6. The catheter 28 is then further retracted into the right atrium 12 to allow coil 47b of the second energy delivery element 22 to deploy in the right atrium 12. According to the invention, in one embodiment, the energy delivery element 22 is maintained in an uncoiled state within the delivery catheter 28 and when deployed from the delivery catheter 28, the energy delivery element 22 forms a coiled state. After deployment of the energy delivering element 22, energy is applied to the septum primum 8, septum secundum 10, and the tunnel 23, and the energy delivery element 22 is subsequently removed by recapture into the delivery catheter 28.
In another embodiment of a method for delivering the device of
Next, the delivery catheter 28 is retracted into the right atrium 12 and the loops 21 of the second coil 47b of the energy delivery element 22 are deployed in the right atrium 12. In one embodiment, the loops 21 on the right atrial side 12 of the defect 14 appose the right atrial side of the septum primum 8 and septum secundum 10. Energy is delivered to the septum primum 8 and the septum secundum 10 via the energy delivery element 22, and the energy delivery element 22 is then recaptured by the catheter 28, with the portion of the energy delivery element 22 on the left atrial side 6 passing through the hole 59 in the septum primum 8. In another embodiment, the catheter 28 is instead introduced into the left atrial space 6 via a trans-septal puncture of the septum secundum 10.
As shown in
In a further embodiment, in addition to an energy delivery element 22 including a hook-like electrode 63 as shown in
After the hook-like electrode 63 of the energy delivery element 22 is deployed in the left atrium 6, the operator further retracts the delivery catheter 28 proximally into the right atrium 12 to deploy the second energy delivery element on the right atrial side 12 of the patent foramen ovale 14. In one embodiment, the second energy delivery element is continuous with the first energy delivery element 22, while in another embodiment, the second energy delivery element is a separate body from the first energy delivery element 22. With the second energy delivery element apposing the septum primum 8 and septum secundum 10 on the right atrial side 12 and the hook-like electrode 63 of the first energy delivery element 22 apposing the left atrial side 6 of the septum primum 8 against the septum secundum 19, the operator activates the energy source 26, delivering energy to the patent foramen ovale 14. The operator then removes the energy delivery elements 22 by retracting them into the delivery catheter 28.
While the energy delivery element 22 of
As shown in
Similar to the multi-hook energy delivery elements of
An intracardiac occluder 66 has one occlusion shell 62 in one embodiment, while in another embodiment, the intracardiac occluder 66 has two or more occlusion shells 62a, 62b (collectively 62). For example, the framework 71 extending on a first side of the central hub 68 is a first occlusion shell 62a, while the framework 71 extending on an opposite second side of the central hub 68 is a second occlusion shell 62b. Alternatively, attached to the strut frameworks 71 are patches 65a, 65b (collectively 65) which, when the occluder 66 is deployed, cover and occlude the patent foramen ovale 14.
As shown in
As shown in
As shown in
Alternatively, in another embodiment, the occluder 66 has two occlusion shells 62, as discussed below in relation to
In one embodiment, the occlusion shell 62 is an embodiment described in U.S. Pat. No. 5,425,744, the entire disclosure of which is incorporated by reference herein. In another embodiment, the occlusion shell 62 is an embodiment described in U.S. Pat. No. 5,451,235, the entire disclosure of which is incorporated by reference herein. In yet another embodiment, the occlusion shell 62 is an embodiment described in U.S. Pat. No. 5,709,707, the entire disclosure of which is incorporated by reference herein.
In one embodiment, the occlusion shell 62 assists in the apposition of the septum primum 8 and the septum secundum 10. In another embodiment, the occlusion shell 62 may also act as an electrode for the delivery of energy to the septum primum 8 and the septum secundum 10 of the patent foramen ovale 14. After the energy delivery element 22 and the occlusion shell 62 are appropriately positioned, energy is delivered to the septum primum 8 and septum secundum 10, and the tunnel 23 of the patent foramen ovale 14, welding the septum primum 8 and the septum secundum 10 together. In one embodiment, the energy delivery element 22 and occlusion shell or shells 62 are then removed and the intracardiac defect is allowed to heal. In another embodiment, the hook-like electrodes 63 are removed, while the occlusion shell or shells 62 remain implanted at the site of the patent foramen ovale 14.
The occluder 66 is connected permanently to the distal end 27 of the cable 24 in one embodiment, while in another embodiment, the occluder 66 is connected releasably to the distal end 27 of the cable 24. For example, in one embodiment, the occluder 66 is attached to the cable 24 via an attachment device. A non-exhaustive list of attachment devices include a ball-rod connection, a ball-socket connection, a ball-claw connection, a threaded connection, a looped connection, a magnetic connection, a male-female connection, an adhesive connection, a clamped connection, and a hook-eye connection. In a further embodiment, the attachment device is insulated, for example by a coating or sleeve of non-conductive material.
In one embodiment, at least one of the occlusion shells 62 includes a plurality of struts 71 which radiate from the central hub 68, with each strut including one flexural point (not shown) about which the strut may flex. In a further embodiment, a first strut 71 from a first occlusion shell 62a is connected with a first strut of a second occlusion shell 62b via a centering mechanism. In another embodiment, a first strut 71 of a first occlusion shell 62a is connected to a first strut 71 of a second occlusion shell 62b, and a second strut 71 of a first occlusion shell 62a is connected to a second strut 71 of a second occlusion shell 62b. For example, in one embodiment the connection is formed by an elastomeric material.
The strut framework 71 of one or more occlusion shells 62 is covered with a biocompatible or bioabsorbable patch 65a, 65b (collectively 65), as disclosed in U.S. Pat. No. 5,425,744. Other types of occlusion shells, e.g., those disclosed in U.S. Pat. No. 5,425,744, 5,451,235, or 5,709,707 may also be used. In one embodiment, the patch 65 includes a conductive material such as metal, for example, a metal mesh, or a conductive polymer to enhance the delivery of energy to the intracardiac defect. In a further embodiment, the patch 65 includes one or both of an adhesive or growth stimulating substance that is deposited on the septum primum 8 and septum secundum 10 of the patent foramen ovale 14 to enhance defect closure. In a further embodiment, the patch 65 includes a biological material such as collagen or submucosa.
In another embodiment, the arms or struts 71 of the occlusion shell 62 include a coil, such as for example, a helically curved strut or a spiral strut 71. According to one embodiment, the occlusion shell 62 has any number of arms or struts 71.
In order to deliver the energy delivery element 22 including the occluder 66 to the patent foramen ovale 14, the catheter 28 is inserted into the left atrium 6 through the tunnel 23 of the patent foramen ovale 14. As shown in
In one embodiment, the occlusion shell 62 assists in apposing the septum primum 8 and the septum secundum 10. In another embodiment, the occlusion shells 62a, 62b act as electrodes for the delivery of energy to the septum primum 8 and the septum secundum 10 of the patent foramen ovale 14. After energy is delivery to the septum primum 8, the septum secundum 10, and the tunnel 13 of the patent foramen ovale 14, the septum primum 8 and the septum secundum 10 weld together, according to one embodiment of the invention. In a further embodiment, any hook-like electrode 63 is removed from the patent foramen ovale 14, while the occlusion shell or shells 62 remain implanted at the site of the patent foramen ovale 14.
As shown in
With continued reference to
In order to deploy the energy delivery element 22 at the site of the patent foramen ovale 14, the operator introduces the catheter 80 housing the vacuum force containing element 79 and the energy delivery element 22 into the left atrium 6. As shown in
The vacuum force is strong enough to remove any debris from the area and causes the septum primum 8 and septum secundum 10 to come together, closing the tunnel 23. The energy delivery element 22 delivers energy to the patent foramen ovale 14 at any point before, during or after the application of the vacuum force. In one embodiment, once the energy has been delivered and the vacuum force applied, both the vacuum force containing element 79 and the occlusion shells 62 are retracted from the patent foramen ovale 14. In another embodiment, the vacuum force containing element 79 is removed and the occlusion shells 62 of the occluder 66 remain permanently implanted at the site of the patent foramen ovale 14.
The braided energy delivery element 22, according to one embodiment of the invention, is connected at its proximal section to cable 24. Cable 24 is connected to an actuating mechanism (not shown). In order to move the braided energy delivery element 22, an operator moves the actuating member proximally to move the energy delivery element 22 proximally, while the operator moves the actuating member distally to move the energy delivery element 22 distally.
In a further embodiment, the distal 85, middle 83 and proximal 81 sections of the braided energy delivery device 22 are composed of a braided material, such as a woven, plaited, or mesh fabric. According to one embodiment, the mesh may be made of any suitable metal such as, but not limited to, stainless steel or a shape memory alloy such as nitinol. Alternatively, the mesh may be made of a conductive polymer or other conductive material that can be woven into a mesh-like structure. For example, the distal 81, middle 83, and proximal 85 sections in one embodiment are composed of one contiguous piece of wire mesh.
In another embodiment, the braided energy delivery element 22 comprises a distal section 81, a middle section 83, and a proximal section 85 wherein each section is a separate component joined together, for example by a joining piece such as a hinge (not shown). In yet another embodiment, the joining piece, such as a hinge, is activated by energy causing the distal 85 and proximal 81 sections of braided material to clamp the septum primum 8 and septum secundum 10, apposing those tissues.
In another embodiment, one or more of the proximal 81, distal 85 and middle 83 sections may include one or more non-braided portions. For example, the proximal section 81 and the distal section 85 of the energy delivery element in one embodiment are composed of a braided material, while the middle section 83 is made of a solid piece of metal or other conductive material. In an alternate embodiment, the proximal and distal sections 81, 85 are composed of a braided material, while the middle section 83 includes a braided portion and a non-braided portion, i.e., a solid piece of metal.
In a further embodiment, the braided energy delivery element or at least one or more of the proximal 81, distal 85, or middle section 83 is coated with one or more of an adhesive, a bioabsorbable material, a metal of low melting point, a polymer, or a growth stimulating substance. The coating is released from the energy delivery element 22 and deposited at the patent foramen ovale before, during or after application of the energy to assist in the closure of the patent foramen ovale 14.
The braided energy delivery element 22 is delivered to the patent foramen ovale 14 via a catheter 28 which maintains the energy delivery element 22 in a compressed configuration until the operator retracts the catheter 28 proximally to deploy the energy delivery element 22. As shown in
Another advantage of using a braided energy delivery element 22 includes the ability to deliver energy over the entire element 22 or to only deliver energy to one or more specific sites on the braid 22. For example,
In another embodiment, (not shown) energy is delivered along one or more linear pathways of the braided energy delivery element 22. Alternatively, energy may be delivered along a broken pathway of the braided energy delivery element 22. In another embodiment, energy can be delivered in geometric pattern such as a circular, square shaped or oval shaped pathway; however, any suitable geometric pathway may be used. In another embodiment, portions of the braided energy delivery element 22 are insulated with a sleeve or coating of a non-conductive material to facilitate the concentration of energy delivery at a point location, or along a linear, geometric or broken pathway.
As shown in
In a further embodiment, the plug 90 expands to occlude the tunnel 23 when energy is applied. As shown in
In one embodiment, the plug 90 includes a bioabsorbable material such as tissue, preferably human tissue. In another embodiment, the plug 90 includes a polymer that upon application of energy, expands to fill the defect. In yet another embodiment, the plug 90 includes a shape memory alloy material that expands upon application of energy, and the plug 90, itself, acts as an energy delivery element 22. For example, in one embodiment, the shape memory alloy is nitinol. In a further embodiment, a plug 90 including a shape memory alloy delivers energy to a point or points on the plug 90, along one or more linear pathways, or to the entire plug 90.
In a further embodiment the plug 90 is permanently implanted into the tunnel 23 of the patent foramen ovale 14, while in another embodiment, the plug 90 is removable.
In a further embodiment, the plug 90 is encompassed by a sleeve or coating. For example, the sleeve or coating may include an adhesive, a bioabsorbable material, a polymer, a growth promoting substance, collagen, or a metal with a low melting point. According to one embodiment of the invention, the sleeve or coating is deposited in the patent foramen ovale 14 along with plug 90.
As shown in
The plug 90 is introduced into the tunnel 23 of a patent foramen ovale 14, along with an intracardiac occluder 66, according to methods previously described herein. In one embodiment, the plug 90 is coaxial with the middle section 93 of the occluder 66, while in another embodiment, the plug 90 is adjacent to the middle section 93 of the occluder 66. In one embodiment, the occluder 66 includes two occlusion shells 62 with the proximal occlusion shell 62a being deployed in the right atrium 12 and the distal occlusion shell 62b being deployed in the left atrium 6 according to methods previously disclosed herein. The occluder 66 may be of any suitable geometry, such as, but not limited to a spiral shaped occluder, an umbrella shaped occluder, a petal shaped occluder, or a flat monolithic body, or any other type of occluder, e.g., those disclosed in U.S. Pat. No. 5,425,744, 5,451,235, or 5,709,707. In one embodiment, the occluder 66 is a bioabsorbable occluder.
All the embodiments of energy delivery elements 22 described herein can include a coating or sleeve on the energy delivery element 22 which bonds to the septum primum 8 and septum secundum 10 of the patent foramen ovale 14. The sleeve or coating may be made from one or more bioresorbable materials, adhesives, polymers, or metals, and maybe include growth stimulating substances. According to one embodiment, when the energy delivery element 22 is withdrawn from the patent foramen ovale 14, the coating or sleeve remains at the site of the defect 14, improving closure of the tunnel 23.
Furthermore, the invention described herein contemplates that all embodiments of the energy delivery elements 22 disclosed herein can be delivered to the site of an intracardiac defect 14 such as a patent foramen ovale 14 in conjunction with a vacuum catheter system 80 as described herein.
In addition, all energy delivery elements 22 disclosed herein, can be made of a shape memory alloy, such as nitinol. Because shape memory properties of a metal are activated by changes in temperature of the metal, the various energy delivery elements 22 described herein can thus be designed to provide a temporary clamping force on the septum primum 8 and septum secundum 10 when energy is applied.
Moreover, because applying energy causes coagulation of the tissue, all energy delivery elements 22 disclosed herein can be coated with a non-stick surface such as polytetrafluoroethylene (PTFE) to ease removal of the energy delivery element 22 from the patent foramen ovale 14.
In addition, any of the embodiments herein are useful for closing any intracardiac defect, such as an atrial septal defect, a ventricular septal defect, and for obliteration of a left atrial appendage.
Variations, modifications, and other implementations of what is described herein will occur to those of ordinary skill in the art without departing from the spirit and scope of the invention as claimed. Accordingly, the invention is to be defined not by the preceding illustrative description alone, but by the spirit and scope of the following claims.
This application is a divisional application of U.S. patent application Ser. No. 11/516,145, filed on Sep. 6, 2006, which claims priority to and the benefit of U.S. Provisional Patent Application Ser. No. 60/714,332, filed on Sep. 6, 2005. The entire contents of each of the above applications are incorporated by reference herein.
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| Number | Date | Country | |
|---|---|---|---|
| 20100312236 A1 | Dec 2010 | US |
| Number | Date | Country | |
|---|---|---|---|
| 60714332 | Sep 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 11516145 | Sep 2006 | US |
| Child | 12856654 | US |
