US20170035433A1 - Left atrial appendage occluder device anchoring system, anchor, and method of attachment - Google Patents

Abstract

The present invention relates in general to anchoring systems for occluder devices, and more specifically, to an anchoring system and method for implanting an occluder device within a left atrial appendage (“LAA”) of the heart. The anchoring system is configured so that an anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of an LAA wall. The purpose of the present invention is to provide an occluder device anchor that has a low risk of embolization and/or causing injury to neighboring valve structures. An additional purpose of the present invention is to provide an anchoring system and method for implanting an occluder device within the LAA that allows for the occluder device to be retrievable after initial placement, reusable, and repositionable for an optimal final placement within the LAA.

Description

FIELD OF THE INVENTION
• The present invention relates in general to an anchoring system and method of attaching and retrieving an occluder device in the left atrial appendage of the heart. The purpose of the invention is to provide an anchoring system and method of attaching and retrieving an occluder device that ensures optimal placement within the left atrial appendage of the heart. A further purpose of the present invention is to provide an anchor for an occluder device that has a low risk of embolization.
BACKGROUND OF THE INVENTION
• Approximately 7 million Americans have what is known as non-valvular atrial fibrillation involving complications with the left atrial appendage of the heart (hereinafter, “LAA”). The LAA is a small, windsock shaped sac in the muscle wall of the left atrium. Though uncertain as to what function the LAA performs, if anything, what is certain is that in patients with non-valvular atrial fibrillation, 90% of the thrombus formation occurs in the body of the LAA. In normal conditions, electrical impulses that control a heartbeat travel in an orderly fashion throughout the heart. These electrical impulses cause the heart to contract wherein blood in the left atrium and LAA is driven into the left ventricle with each heartbeat. However, in patients with atrial fibrillation the electrical impulses are fast and chaotic, wherein many impulses begin at the same time and spread throughout the atria. For instance, a healthy atria contracts 60-80 times per minute, while a fibrillating atria quivers at 300-400 times per minute. Problems arise when the electrical impulses do not allow the atria enough time to fully contract and efficiently displace blood into the left ventricle from the left atrium and LAA. Consequently, blood pools and collects in the LAA due to inefficient contraction of the atria and the LAA's sac-like physiological structure, causing blood clots. Strokes may ultimately occur in patients when the blood clots are pumped out of the heart and embolize to the brain. Notably, individuals with atrial fibrillation are five to seven times more likely to have a stroke than the general population.
• Treatment of atrial fibrillation typically involves oral anticoagulant therapy. Patient's taking blood thinners have noted a reduction in the risk of stroke by 65% as compared to patients without medication. The oral anticoagulant warfarin (COUMADIN®) has been traditionally utilized to minimize thrombus formation in patients with atrial fibrillation. Due to the requirement of frequent blood draws to monitor a patient's anticoagulation status, frequent interactions of the medication with either dietary changes or with other medications, and the high risk of encountering serious bleeding events, Coumadin has recently fallen into disfavor in the medical community. Newer medications including dabigatran (PRADAXA®) and rivaroxaban (XARELTO®) are also being utilized. The advantage of these newer medications are that they have less interaction with dietary changes and do not require blood draws to monitor a patient's anticoagulation status. However, these medications continue to encounter serious gastrointestinal bleeding events, are not reversible, and are extremely expensive.
• Patients who cannot tolerate anticoagulants, or are not eligible for anticoagulant treatment due to pregnancy or other medical reasons, may elect to undertake various procedures to seal off or remove the LAA. One particular procedure, known as LAA occlusion, involves implanting a device into the heart that closes the LAA. Currently, there are several different occluder devices on the market or in current testing, including the WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and the AMULET™. In each of these devices, the major technical difficulty encountered is to get the device to reliably fix itself within the LAA without embolizing or migrating out of the LAA into the systemic circulation. The reason for this is multifactorial, although primarily being related to the LAA coming in many different sizes and configurations. Some sizes and configurations of the LAA are more amenable to device closure, whereas in others, device closure can be extremely difficult—if not impossible—to safely place an occluder device within the LAA.
• The heart is comprised of three layers: (1) an inner endocardium layer; (2) a middle myocardium layer; and (3) an outer epicardium layer. The endocardium is a fragile, thin layer of tissue that lines the heart's chambers and valves. The myocardium is the thickest layer of the heart and is comprised of muscle tissue. The epicardium is a thin layer of visceral tissue. Between the heart and mediastinal space is the pericardium. The pericardium is a visceral layer of endothelium. The pericardial space lies in between the heart's epicardial surface and the pericardium. The pericardial space is filled with clear fluid that minimizes friction between the heart and other structures within the chest wall.
• Current LAA occluder devices such as the WATCHMAN® and AMPLATZER™ have barbs on the outer edge of the device that latch on circumferentially to the endocardium layer of the LAA. Using barbs to fix the occluder device onto the endocardium layer of the LAA has significant disadvantages. For example, successfully “latching” an occluder device onto the endocardial layer of the LAA may be extremely difficult and time consuming for the interventional cardiologist. Problems are compounded if initial placement of the occluder device within the LAA is less than ideal, as the occluder device cannot be fully retrieved back within the delivery system without permanently damaging the retention barbs and/or the endocardium layer. Moreover, if the occluder device embolizes out of the LAA, irreparable damage to neighboring structures such as the mitral and/or aortic valves of the heart may occur in part, due to the presence of the barbs on the occluder device. Retrieval of an embolized occluder device is further complicated by the presence of the retention barbs.
• Therefore, what is needed is an anchoring system and method for implanting an occluder device in the LAA that would allow for complete retraction and removal of the occluder device without permanently damaging the device. What is also needed is an anchoring system and method for implanting an occluder device in the LAA that provides a low risk of embolization and/or causing injury to neighboring valve structures. What is further needed is an anchoring system and method for implanting an occluder device that allows the occluder device to be positioned in multiple locations within the LAA, being able to be used in all types of LAA anatomy, and still result in optimal final placement of the occluder device within the LAA.
BRIEF SUMMARY OF THE INVENTION
• Therefore, it is a principal object, feature, and/or advantage of the present invention to overcome the aforementioned deficiencies in the art and provide an anchoring system and method for implanting and retrieving an occluder device in the LAA.
• A further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting and retrieving an occluder device in the LAA that may be used with a diverse range of LAA occluder devices.
• Another object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting and recapturing an occluder device in the LAA that minimizes the risk of the occluder device embolizing or migrating following release of the occluder device into the LAA.
• Yet another object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that allows an interventional cardiologist to anchor the occluder device in multiple locations within the LAA.
• A still further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that allows the occluder device to be retrieved and adjusted within the LAA to achieve an optimal final position.
• Another object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that causes minimal or no bleeding into the pericardial space upon anchoring.
• A further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that is easy to implant and retrieve by an interventional cardiologist.
• A still further object, feature, and/or advantage of the present invention is to provide an anchoring system and method for implanting an occluder device in the LAA that allows the occluder device to be retrieved and adjusted by a interventional cardiologist within the LAA without damaging the occluder device.
• These and/or other objects, features, and/or advantages of the present invention will be apparent to those skilled in the art. The present invention is not to be limited to or by these objects, features, and advantages. No single aspect need provide each and every object, feature, or advantage.
• According to one aspect of the present invention, an anchoring system for implanting and retrieving an occluder device into a LAA comprises an outer sheath and a pericardial catheter. The pericardial catheter may be advanced through the outer sheath into the LAA, wherein the pericardial catheter penetrates a wall of the LAA and enters the pericardial space creating a small hole. A buddy wire and/or a delivery wire are advanced through the pericardial catheter to enter the pericardial space. The anchoring system of the present invention further comprises an anchor, an occluder device, and a flexible connector. The occluder device may be attached to the anchor via the connector. After the pericardial catheter is removed from the outer sheath, the anchor, the connector, and the occluder device are advanced through the outer sheath. The anchor is further advanced to penetrate the LAA wall via the small hole and extend into the pericardial space. Specifically, the anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall. Once inside the pericardial space, the anchor self-expands to implant the base in the LAA wall. The anchor is further configured to prevent the occluder device from being pushed through the small hole into the pericardial space. The outer sheath releases the occluder device into the LAA, wherein it is held in position by the anchor. By mooring the occluder device through all three layers of the LAA wall via the anchor, the risk of embolization is reduced. Another aspect of the present invention includes a method of implanting and retrieving an occluder device into a LAA using the anchoring system described above.
• According to a further aspect of the present invention, an anchoring system for implanting and retrieving an occluder device into a LAA comprises an outer sheath, a pericardial catheter, an occluder device, and an anchor. The pericardial catheter may be advanced through the outer sheath into the LAA, wherein the pericardial catheter penetrates a wall of the LAA and enters the pericardial space creating a small hole. The anchor may comprise a sheave shape with a first half and a second half connected by a shaft. The anchor may further comprise a contracted first position and a deployed second position. After the pericardial catheter is removed from the outer sheath, the occluder device, anchor catheter, and anchor are advanced through the outer sheath using the delivery wire, wherein the anchor is in the contracted first position. The anchor catheter is further advanced to penetrate the LAA wall via the small hole and extend into the pericardial space. Specifically, the anchor catheter delivers the anchor, wherein the first half of the anchor remains inside the LAA and the shaft portion and the second half of the anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall. Once inside the pericardial space, the second half of the anchor self-expands to the deployed second position within the pericardial space to implant the anchor in the LAA wall. The first half of the anchor remaining within the LAA also self-expands to the deployed second position, pinning the occluder device against the wall of the LAA. The outer sheath releases the occluder device into the LAA, wherein it is held in position by the anchor. By mooring the occluder device through all three layers of the LAA wall via the anchor, the risk of embolization is reduced. Another aspect of the present invention, a method of implanting and retrieving an occluder device into a LAA is provided. Another aspect of the present invention includes a method of implanting and retrieving an occluder device into a LAA using the anchoring system described above.
• According to yet a further aspect of the present invention, an anchoring system for implanting and retrieving an occluder device into a LAA comprises an outer sheath, a pericardial catheter, an occluder device, and an anchor. The pericardial catheter may be advanced through the outer sheath into the LAA, wherein the pericardial catheter penetrates a wall of the LAA and enters the pericardial space creating a small hole. A buddy wire and/or a delivery wire are advanced through the pericardial catheter to enter the pericardial space. After the pericardial catheter is removed from the outer sheath, an anchor catheter, the occluder device, and the anchor are then advanced through the outer sheath using the delivery wire. While in a straight-coil configuration, the anchor penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall to extend into the pericardial space. When the delivery wire is retrieved, the anchor self-expands into a two-disc shape, wherein a first coil resides within the LAA and a second coil resides within the pericardial space. The outer sheath releases the occluder device into the LAA, wherein it is pinned against the LAA wall by the anchor. By mooring the occluder device through all three layers of the LAA wall via the anchor, the risk of embolization is reduced. Another aspect of the present invention includes a method of implanting and retrieving an occluder device into a LAA using the anchoring system described above.
• Different aspects may meet different objects of the invention. Other objectives and advantages of this invention will be more apparent in the following detailed description taken in conjunction with the figures. The present invention is not to be limited by or to these objects, aspects, or figures.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIGS. 1-26 represent examples of the anchoring system, anchor, and method of the present invention.
• FIG. 1 is a view of an outer sheath and pericardial catheter of an anchoring system of the present invention and method for implanting and retrieving an occluder device within a LAA.
• FIG. 2 is a view of an anchor, connector, and occluder device of the anchoring system and method ofFIG. 1.
• FIG. 3 is a view of an anchor of the anchoring system and method of claim1, wherein the anchor comprises anchor tines.
• FIG. 3A is an end-view of the anchor ofFIG. 3, wherein anchor tines are in a contracted first position.
• FIG. 3B is an end-view of the anchor ofFIG. 3, wherein the anchor tines are in a deployed second position.
• FIG. 4 is a view of an anchor of the anchoring system and method ofFIG. 1, wherein the anchor comprises a coil-wire.
• FIG. 4A is an end-view of the anchor ofFIG. 4, wherein a coil-wire is in a contracted first position constrained within an inner sheath.
• FIG. 4B is an end-view of the anchor ofFIG. 4, wherein the coil-wire is in a deployed second position within the pericardial space.
• FIG. 5 is a view of the anchoring system and method ofFIG. 1, wherein the anchor and the occluder device are advanced into the LAA.
• FIG. 6 is a view of the anchoring system and method ofFIG. 5, wherein the anchor is advanced through the LAA wall.
• FIG. 7 is a view of the anchoring system and method ofFIG. 6, wherein the occluder device is released from the inner sheath and positioned within the LAA.
• FIG. 8 is a view of the anchoring system and method ofFIG. 7, wherein the occluder device is retrieved inside the inner sheath and the anchor is left implanted in the LAA wall, sealing up the small hole created by the pericardial catheter.
• FIG. 9 is a view of the anchoring system and method ofFIG. 8, wherein the anchor is retracted from the LAA wall and the anchor and the occluder device are retrieved inside the inner sheath.
• FIG. 10 is a view of an outer sheath and a pericardial catheter of another aspect of an anchoring system of the present invention and method for implanting and retrieving an occluder device within a LAA.
• FIG. 11 is a view of an outer sheath, anchor catheter, and inner dilator of the anchoring system and method ofFIG. 10, wherein the inner dilator and anchor catheter penetrate the LAA wall.
• FIG. 12 is a view the anchoring system and method ofFIG. 10, wherein an occluder device and an anchor are advanced through the outer sheath and anchor catheter, respectively.
• FIG. 13 is a frontal-side view of the anchor of the anchoring system and method ofFIG. 10, wherein the anchor comprises a sheave shape with a first half, a second half, and a shaft connecting the two halves.
• FIG. 13A is a side-view of the anchor ofFIG. 13, wherein the anchor is in a contracted first position.
• FIG. 13B is a side-view of the anchor ofFIG. 13, wherein the anchor is in a deployed second position.
• FIG. 14 is a view of the anchoring system and method ofFIG. 1, wherein the second half of the anchor is deployed in the pericardial space.
• FIG. 15 is a view of the anchoring system and method ofFIG. 1, wherein the first half of the anchor is partially deployed in the occluder device.
• FIG. 16 is a view of the anchoring system and method ofFIG. 1, wherein the occluder device is released from the outer sheath and the second half of the anchor fully deployed to pin the occluder device against the LAA wall.
• FIG. 17 is a view of the anchoring system and method ofFIG. 1 if problems arise after deployment of the occluder device, wherein the occluder device is retracted inside the outer sheath and the first half of the anchor is retracted inside the anchor catheter.
• FIG. 18 is a view of the anchoring system and method ofFIG. 1 if problems arise after deployment of the occluder device, wherein the anchor is left implanted in the LAA wall.
• FIG. 19 is a view of an outer sheath and pericardial catheter of another aspect of an anchoring system of the present invention and method for implanting and retrieving an occluder device within a LAA.
• FIG. 20 is a view the anchoring system and method ofFIG. 19, wherein an occluder device is advanced through the outer sheath and an anchor is advanced through the anchor catheter.
• FIG. 21A is a side-view of the anchor ofFIG. 20, wherein the anchor is in a contracted first position.
• FIG. 21B is a side-view of the anchor ofFIG. 20, wherein the anchor is in a deployed second position comprising a double-coiled shape with a first half, a second half, and a shaft connecting the two halves.
• FIG. 22 is a view of the anchoring system and method ofFIG. 19, wherein the second half of the anchor is deployed in the pericardial space.
• FIG. 23 is a view of the anchoring system and method ofFIG. 19, wherein the first half of the anchor is partially deployed in the occluder device.
• FIG. 24 is a view of the anchoring system and method ofFIG. 19, wherein the occluder device is released from the outer sheath and the first half of the anchor is fully deployed to pin the occluder device against the LAA wall.
• FIG. 25 is a view of the anchoring system and method ofFIG. 19 if problems arise after deployment of the occluder device, wherein the occluder device is retracted inside the outer sheath and the first half of the anchor is retracted inside the anchor catheter.
• FIG. 26 is a view of the anchoring system and method ofFIG. 19 if problems arise after deployment of the occluder device, wherein the anchor is left implanted in the LAA wall.
DETAILED DESCRIPTION OF THE INVENTION
• FIG. 1 illustrates one aspect of the present invention, ananchoring system10 for implanting and retrieving an occluder device within a LAA. The anchoringsystem10 may comprise apericardial catheter14, wherein thepericardial catheter14 may be a single or double-lumen pericardial catheter. The anchoringsystem10 may further comprise anouter sheath16 and aninner sheath18. A balloon-occlusion catheter may also be utilized by the present invention. However, it is intended that other catheters standard in the industry may also be utilized. The single or double-lumenpericardial catheter14 may be configured to fit adelivery wire20 and/or abuddy wire22, also standardly used in the industry. A diameter of thedelivery wire20 may range between approximately 0.025-0.052 inches and a diameter of thebuddy wire22 may range between approximately 0.008 0.025 inches.
• Further illustrated inFIG. 1, theouter sheath16 may be inserted intoLAA24 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude theLAA24 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of theouter sheath16 within theLAA24 and allow for better imaging of theLAA24 by an interventional cardiologist. Thepericardial catheter14 may be advanced through theouter sheath16, wherein thepericardial catheter14penetrates LAA wall26 and enterspericardial space28. Specifically, thepericardial catheter14 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26. Thus, thepericardial catheter14 creates asmall hole30 through theLAA wall26 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of bleeding and fluid accumulating within thepericardial space28 via thesmall hole30. While thepericardial catheter14 remains inside thepericardial space28 via thesmall hole30, thedelivery wire20 and/or thebuddy wire22 may be advanced through thepericardial catheter14, wherein thedelivery wire20 and/or thebuddy wire22 enter thepericardial space28. Thebuddy wire22 remains inside thepericardial space28 and is a safety feature in case of emergencies. Thebuddy wire22 allows a interventional cardiologist to advance another catheter through theLAA wall26 and place a plug within thesmall hole30 if a malfunction is observed with theanchor32 or theoccluder device36. Thepericardial catheter14 may then be removed from theouter sheath16, leaving thedelivery wire20 and/or thebuddy wire22 inside thepericardial space28 via thesmall hole30 in theLAA wall26.
• Illustrated inFIG. 2, the anchoringsystem10 of the present invention further comprises ananchor32, anoccluder device36, and aconnector38. It is contemplated that theanchoring system10 of the present invention may be used with a diverse range of LAA occluder devices such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples of occluder devices that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™.
• Further illustrated inFIG. 2, theoccluder device36 is connected to theanchor32 via theconnector38. Theconnector38 may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or other materials standardly used in the industry. Theconnector38 may be square, flat, rectangular, round, spherical, coiled, ovular, a combination thereof, or any other shape. Theconnector38 may be approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It is intended that theconnector38 provide flexibility between theanchor32 and theoccluder device36. This flexibility may be achieved via an articulating joint, such as a ball-and-socket joint44, shown inFIG. 2. The ball-and-socket joint44 ofFIG. 2 is illustrated for example purposes only. It is not intended that theconnector38 of the present invention be limited to a ball-and-socket joint44. Rather, it is intended that other articulating connectors standardly used in the industry may also be utilized, such as hinge joints, pivot joints, ellipsoid joints, gliding joints, saddle joints, and others. It is important that theconnector38 provide flexibility between theoccluder device36 and theanchor32 to allow for multiple insertion sites within theLAA24, thus, ensuring theoccluder device36 is properly positioned within theLAA24 once deployed. Furthermore, theconnector38 may allow an interventional cardiologist via a cable (not shown) to conveniently attach theoccluder device36 to theanchor32, release theoccluder device36 from theanchor32, and reattach theoccluder device36 to theanchor32 without damaging theoccluder device36.
• Illustrated inFIG. 3, theanchor32 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The length of theanchor32 may be approximately 1-10 mm, wherein the width of theanchor32 may be approximately 1-20 mm. Theanchor32 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor32 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Further illustrated inFIG. 3, theanchor32 may comprise a plurality of self-expandinganchor tines39, wherein the plurality may comprise 2-10 tines. The anchor tines39 may be approximately 5-20 mm in length and approximately 0.01-1.5 mm in width. The anchor tines39 may be circular in cross-section, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The anchor tines39 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The anchor tines39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that theanchor tines39 may comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Alternatively, theanchor32 of the present invention may comprise a self-expanding coil-wire40 instead of theanchor tines39 as illustrated inFIG. 4. The coil-wire40 may be approximately 5-25 mm in length and 0.01-1.5 mm in width. The coil-wire40 may be circular in cross-section, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The coil-wire40 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The coil-wire40 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the coil-wire40 may comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Theanchor32 may have a contracted first position (FIGS. 3A, 4A) and a deployed second position (FIGS. 3B, 4B). When theanchor tines39 are utilized, theanchor tines39 may expand outwards a distance of approximately 2-20 mm in diameter in the deployed second position (FIG. 3B). Alternatively when the coil-wire40 is utilized, the coil-wire may have a circular diameter of 0.01-1.5 mm in the contracted first position (FIG. 4A), and may have a circular diameter of approximately 5-20 mm in the deployed second position (FIG. 4B). However, it is contemplated that the diameter of the contracted first position and deployed second position of the coil-wire40 may have any shape compatible with theLAA24.
• Illustrated inFIG. 5, theinner sheath18 is advanced up to and adjacent theLAA wall26. Theanchor32, theconnector38, and theoccluder device36 are next advanced through theinner sheath18 using thedelivery wire20, wherein theanchor32 resides adjacent thesmall hole30 in theLAA wall26.
• Illustrated inFIG. 6, theanchor32, theconnector38, and theoccluder device36 are further advanced through theinner sheath18 using thedelivery wire20, wherein theanchor32 penetrates theLAA wall26 via thesmall hole30 and extends into thepericardial space28. Specifically, theanchor32 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26. Once inside thepericardial space28, theanchor32 self-expands from the contracted first position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B, 4B).
• Illustrated inFIG. 7, theinner sheath18 is retracted inside theouter sheath16 after theanchor32 has been implanted in theLAA wall26. This effectively releases theoccluder device36 into theLAA24. The expandedanchor32 in the deployed second position (FIGS. 3B, 4B) covers a large surface area and therefore retains theoccluder device36 in an implanted position within theLAA24. Moreover, by anchoring theoccluder device36 via theanchor32 through all three layers of theLAA wall26—instead of merely latching onto the thin endocardium layer—theanchoring system10 of the present invention lowers the risk of embolization.
• FIGS. 8-9 illustrate theanchoring system10 of the present invention if problems arise after deployment of theoccluder device36. For instance, it may be determined that theoccluder device36 is not placed in an optimal location of theLAA24 after deployment to achieve maximum occlusion. The anchoringsystem10 of the present invention offers two solutions to overcome these problems.
• The first solution is illustrated inFIG. 8, wherein an interventional cardiologist may use a cable (not shown) to detach42 theoccluder device36 from theanchor32 viaconnector38. Theoccluder device36 is then retrieved inside theinner sheath18 via the cable. Theanchor32 is expendable and may be left implanted in theLAA wall26 where it causes no harm to the patient. Anew anchor32 is then connected to theoccluder device36 via theconnector38, and the anchoring steps repeated until optimal placement of theoccluder device36 within theLAA24 is achieved.
• The second solution is illustrated inFIG. 9, wherein theoccluder device36 is retrieved inside theinner sheath18 via a cable (not shown). Theinner sheath18 is then advanced to envelope theanchor32 and press up against theLAA wall26. While theinner sheath18 is pressed up against theLAA wall26, theanchor32 is pulled back through theLAA wall26, into theLAA24, and retrieved46 inside theinner sheath18 via the cable. Theanchor32 is designed to retract from the deployed second position (FIGS. 3B, 4B) into the contracted first position (FIGS. 3A, 4A) without tearing or ripping theLAA wall26 as theanchor32 is retrieved inside theinner sheath18. Thus, the anchoringsystem10 of the present invention allows an interventional cardiologist to quickly and cost-effectively implant theoccluder device36 into theLAA24 usinganchor32, safely retrieve theoccluder device36 andanchor32 if initial placement was improper or if complications arise, and then reuse and re-implant theoccluder device36 andanchor32 in an optimal location of theLAA24. Ultimately after optimal placement of the occluder device within the LAA is achieved, thedelivery wire20 andbuddy wire22 are removed from the LAA via the outer16 sheath. Theouter sheath16 may be subsequently removed from theLAA24 via the left atrium proper of the heart.
• In another aspect of the present invention, ananchor32 is provided for anchoring anoccluder device36 within theLAA24. As illustrated inFIG. 3, theanchor32 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The length of theanchor32 may be approximately 1-10 mm, wherein the width of theanchor32 may be approximately 1-20 mm. Theanchor32 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor32 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Illustrated inFIG. 2, theanchor32 is further configured to connect to anoccluder device36 via aconnector38. Theconnector38 may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or other materials standardly used in the industry. Theconnector38 may be square, flat, rectangular, round, spherical, coiled, ovular, a combination thereof, or any other shape. Theconnector38 may be approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It is intended that theconnector38 provide flexibility between theanchor32 and theoccluder device36. This flexibility may be achieved via an articulating joint, such as a ball-and-socket joint44, shown inFIG. 2. The ball-and-socket joint44 ofFIG. 2 is illustrated for example purposes only. It is not intended that theconnector38 of the present invention be limited to a ball-and-socket joint44. Rather, it is intended that other articulating connectors standardly used in the industry may also be utilized, such as hinge joints, pivot joints, ellipsoid joints, gliding joints, saddle joints, and others. It is important that theconnector38 provide flexibility between theoccluder device36 and theanchor32 to allow for multiple insertion sites within theLAA24, thus, ensuring theoccluder device36 is properly positioned within theLAA24 once deployed. Furthermore, theconnector38 may allow an interventional cardiologist via a cable (not shown) to conveniently attach theoccluder device36 to theanchor32, release theoccluder device36 from theanchor32, and reattach theoccluder device36 to theanchor32 without damaging theoccluder device36.
• Further illustrated inFIG. 3, theanchor32 may comprise a plurality of self-expandinganchor tines39, wherein the plurality may comprise 2-10 tines. The anchor tines39 may be approximately 5-20 mm in length and approximately 0.01-1.5 mm in width. The anchor tines39 may be circular in cross-section, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The anchor tines39 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The anchor tines39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that theanchor tines39 may comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Alternatively, theanchor32 of the present invention may comprise a self-expanding coil-wire40 instead of theanchor tines39 as illustrated inFIG. 4. The coil-wire40 may be approximately 5-25 mm in length and 0.01-1.5 mm in width. The coil-wire40 may be circular in cross-section, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The coil-wire40 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The coil-wire40 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the coil-wire40 may comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Theanchor32 may have a contracted first position (FIGS. 3A, 4A) and a deployed second position (FIGS. 3B, 4B). When theanchor tines39 are utilized, theanchor tines39 may expand outwards a distance of approximately 2-20 mm in diameter in the deployed second position (FIG. 3B). Alternatively when the coil-wire40 is utilized, the coil-wire may have a circular diameter of 0.01-1.5 mm in the contracted first position (FIG. 4A), and may have a circular diameter of approximately 5-20 mm in the deployed second position (FIG. 4B). However, it is contemplated that the diameter of the contracted first position and deployed second position of the coil-wire40 may have any shape compatible with theLAA24.
• Illustrated inFIG. 6, theanchor32 is configured to penetrate theLAA wall26 via a pre-madesmall hole30 through the LAA wall. Specifically, theanchor32 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26. Theanchor32 extends into thepericardial space28, wherein theanchor32 self-expands from the contracted first position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B, 4B). The expandedanchor32 in the deployed second position (FIGS. 3B, 4B) covers a large surface area and therefore retains theoccluder device36 in an implanted position within theLAA24. Moreover, by anchoring theoccluder device36 via theanchor32 through all three layers of theLAA wall26—instead of merely latching onto the thin endocardium layer—theanchor32 of the present invention lowers the risk of embolization.
• In yet another aspect of the present invention, a method of implanting and retrieving an occluder device within a LAA is illustrated inFIG. 1. The method of the present invention comprises providing ananchoring system10. The anchoringsystem10 comprises apericardial catheter14, wherein thepericardial catheter14 may be a single or double-lumen pericardial catheter. The anchoringsystem10 may further comprise anouter sheath16 and aninner sheath18. A balloon-occlusion catheter may also be utilized in the present invention. However, it is intended that other catheters standard in the industry may also be utilized. Thepericardial catheter14 may be configured to fit adelivery wire20 and/or abuddy wire22, also standardly used in the industry. A diameter of thedelivery wire20 may range between approximately 0.025-0.052 inches and a diameter of thebuddy wire22 may range between approximately 0.008-0.025 inches.
• Further illustrated inFIG. 1, the method of the present invention comprises inserting theouter sheath16 intoLAA24 via the left atrium proper of the heart. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude theLAA24 from the left atrium proper. Next, thepericardial catheter14 may be advanced through theouter sheath16, wherein thepericardial catheter14penetrates LAA wall26 and enterspericardial space28. Specifically, thepericardial catheter14 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26. Thus, thepericardial catheter14 creates asmall hole30 through theLAA wall26 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within thepericardial space28 via thesmall hole30. While thepericardial catheter14 remains inside thepericardial space28 via thesmall hole30, thedelivery wire20 and thebuddy wire22 may be advanced through thepericardial catheter14, wherein thedelivery wire20 and thebuddy wire22 enter thepericardial space28. Thebuddy wire22 remains inside thepericardial space28 and is a safety feature in case of emergencies. Thebuddy wire22 allows an interventional cardiologist to advance another catheter through theLAA wall26 and place a plug within thesmall hole30 if a malfunction is observed with theanchor32 or theoccluder device36. Thepericardial catheter14 may then be removed from theouter sheath16, leaving thedelivery wire20 and thebuddy wire22 inside thepericardial space28 via thesmall hole30 in theLAA wall26.
• Illustrated inFIG. 2, the method of the present invention further comprises providing ananchor32, anoccluder device36, and aconnector38. It is contemplated that the method of the present invention may be used with a diverse range of LAA occluder devices such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples of occluder devices that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™.
• Further illustrated inFIG. 2, the method of the present invention comprises connecting theoccluder device36 to theanchor32 via theconnector38. Theconnector38 may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or other materials standardly used in the industry. Theconnector38 may be square, flat, rectangular, round, spherical, coiled, ovular, a combination thereof, or any other shape. Theconnector38 may be approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It is intended that theconnector38 provide flexibility between theanchor32 and theoccluder device36. This flexibility may be achieved via an articulating joint, such as a ball-and-socket joint44, shown inFIG. 2. The ball-and-socket joint44 ofFIG. 2 is illustrated for example purposes only. It is not intended that theconnector38 of the present invention be limited to a ball-and-socket joint44. Rather, it is intended that other articulating connectors standardly used in the industry may also be utilized, such as hinge joints, pivot joints, ellipsoid joints, gliding joints, saddle joints, and others. It is important that theconnector38 provide flexibility between theoccluder device36 and theanchor32 to allow for multiple insertion sites within theLAA24, thus, ensuring theoccluder device36 is properly positioned within theLAA24 once deployed. Furthermore, theconnector38 may allow an interventional cardiologist via a cable (not shown) to conveniently attach theoccluder device36 to theanchor32, release theoccluder device36 from theanchor32, and reattach theoccluder device36 to theanchor32 without damaging theoccluder device36.
• Illustrated inFIG. 3, theanchor32 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The length of theanchor32 may be approximately 1-10 mm, wherein the width of theanchor32 may be approximately 1-20 mm. Theanchor32 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor32 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Further illustrated inFIG. 3, theanchor32 may comprise a plurality of self-expandinganchor tines39, wherein the plurality may comprise 2-10 tines. The anchor tines39 may be approximately 5-20 mm in length and approximately 0.01-1.5 mm in width. The anchor tines39 may be circular in cross-section, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The anchor tines39 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The anchor tines39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that theanchor tines39 may comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Alternatively, theanchor32 of the present invention may comprise a self-expanding coil-wire40 instead of theanchor tines39 as illustrated inFIG. 4. The coil-wire40 may be approximately 5-25 mm in length and 0.01-1.5 mm in width. The coil-wire40 may be circular in cross-section, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. The coil-wire40 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The coil-wire40 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the coil-wire40 may comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals.
• Theanchor32 may have a contracted first position (FIGS. 3A, 4A) and a deployed second position (FIGS. 3B, 4B). When theanchor tines39 are utilized, theanchor tines39 may expand outwards a distance of approximately 2-20 mm in diameter in the deployed second position (FIG. 3B). Alternatively when the coil-wire40 is utilized, the coil-wire may have a circular diameter of 0.01-1.5 mm in the contracted first position (FIG. 4A), and may have a circular diameter of approximately 5-20 mm in the deployed second position (FIG. 4B). However, it is contemplated that the diameter of the contracted first position and deployed second position of the coil-wire40 may have any shape compatible with theLAA24.
• Illustrated inFIG. 5, the method of the present invention further comprises advancing theinner sheath18 up to and adjacent theLAA wall26. Theanchor32, theconnector38, and theoccluder device36 are next advanced through theinner sheath18 using thedelivery wire20, wherein theanchor32 resides adjacent thesmall hole30 in theLAA wall26.
• Illustrated inFIG. 6, the method of the present invention comprises further advancing theanchor32, theanchor tines39, theconnector38, and theoccluder device36 through theinner sheath18 using thedelivery wire20, wherein theanchor32 penetrates theLAA wall26 via thesmall hole30 and extends into thepericardial space28. Specifically, theanchor32 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26. Once inside thepericardial space28, theanchor32 self-expands from the contracted first position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B, 4B).
• Illustrated inFIG. 7, the method of the present invention further comprises retracting theinner sheath18 inside theouter sheath16 after theanchor32 has been implanted in theLAA wall26. This effectively releases theoccluder device36 into theLAA24. The expandedanchor32 in the deployed second position (FIGS. 3B, 4B) covers a large surface area and therefore retains theoccluder device36 in an implanted position within theLAA24. Moreover, by anchoring theoccluder device36 via theanchor32 through all three layers of theLAA wall26—instead of merely latching onto the thin endocardium layer—theanchoring system10 of the present invention lowers the risk of embolization.
• FIGS. 8-9 illustrate the method of the present invention, further comprising making a determination whether a problem has arisen after deployment of theoccluder device36. For example, it may be determined that theoccluder device36 is not placed in an optimal location of theLAA24 after deployment to achieve maximum occlusion. The method of the present invention offers two alternative solutions to overcome these problems.
• The first solution is illustrated inFIG. 8, wherein an interventional cardiologist may use a cable (not shown) to detach42 theoccluder device36 from theanchor32 viaconnector38. Theoccluder device36 is then retrieved inside theinner sheath18 via the cable. Theanchor32 is expendable and may be left implanted in theLAA wall26 where it causes no harm to the patient. Anew anchor32 is then connected to theoccluder device36 via theconnector38, and the anchoring steps repeated until optimal placement of theoccluder device36 within theLAA24 is achieved.
• The second solution is illustrated inFIG. 9, wherein theoccluder device36 is retrieved inside theinner sheath18 via a cable (not shown). Theinner sheath18 is then advanced to envelope theanchor32 and press up against theLAA wall26. While theinner sheath18 is pressed up against theLAA wall26, theanchor32 is pulled back through theLAA wall26, into theLAA24, and retrieved46 inside theinner sheath18 via the cable. Theanchor32 is designed to retract from the deployed second position (FIGS. 3B, 4B) into the contracted first position (FIGS. 3A, 4A) without tearing or ripping theLAA wall26 as theanchor32 is retrieved inside theinner sheath18. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant theoccluder device36 into theLAA24 usinganchor32, safely retrieve theoccluder device36 andanchor32 if initial placement was improper or if complications arise, and then reuse and re-implant thesame occluder device36 andanchor32 in an optimal location of theLAA24. Ultimately after optimal placement of the occluder device within the LAA is achieved, thedelivery wire20 andbuddy wire22 are removed from the LAA via theouter sheath16. Theouter sheath16 may be subsequently removed from theLAA24 via the left atrium proper of the heart.
• FIG. 10 illustrates a further aspect of the present invention, ananchoring system50 for implanting and retrieving an occluder device within a LAA. The anchoringsystem50 may comprise apericardial catheter54, wherein thepericardial catheter54 may be a single or double-lumen pericardial catheter. The anchoringsystem50 may further comprise anouter sheath56. A balloon-occlusion catheter may also be utilized by the present invention. However, it is intended that other catheters standard in the industry may also be utilized. Thepericardial catheter54 may be configured to fit adelivery wire60 and/or abuddy wire62, also standardly used in the industry. A diameter of thedelivery wire60 may range between approximately 0.025-0.052 inches and a diameter of thebuddy wire62 may range between approximately 0.008-0.025 inches.
• Further illustrated inFIG. 10, theouter sheath56 may be inserted intoLAA64 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude theLAA64 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of theouter sheath56 within theLAA64 and allow for better imaging of theLAA64 by an interventional cardiologist. Thepericardial catheter54 may be advanced through theouter sheath56 to theLAA wall66. Thebuddy wire62 is next advanced through thepericardial catheter54 and theadjacent LAA wall66, wherein thebuddy wire62 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26 to extend into thepericardial space68. Thepericardial catheter54 is next advanced over thebuddy wire62 and through theLAA wall66, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66 to extend into thepericardial space68. Thus, thepericardial catheter54 creates asmall hole70 through theLAA wall66 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within thepericardial space68 via thesmall hole70. While thepericardial catheter54 remains inside thepericardial space68 via thesmall hole70, thedelivery wire60 may then be advanced through thepericardial catheter54, wherein thedelivery wire60 enters thepericardial space68. Thepericardial catheter54 may then be removed from theouter sheath56, leaving thedelivery wire60 and thebuddy wire62 inside thepericardial space68 via thesmall hole70 in theLAA wall66.
• Illustrated inFIG. 11, the anchoringsystem50 of the present invention further comprises ananchor catheter58 and an inner dilator86, wherein the inner dilator86 includes a pointeddistal end88. The inner dilator86 may be configured to encompass thedelivery wire60, wherein thedelivery wire60 may traverse through an inner lumen of the inner dilator86. Theanchor catheter58 and the inner dilator86 may be advanced through theouter sheath56 to theLAA wall66 adjacent thesmall hole70. Particularly, thedelivery wire60 may traverse through the anchor catheter52 and the inner dilator86. Thebuddy wire62 may reside outside theanchor catheter58 and yet inside theouter sheath56. Using the pointeddistal end88 of the inner dilator86, the inner dilator86 and the anchor catheter52 may be further advanced through thesmall hole70 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66. Thus, the pointeddistal end88 of the inner dilator86, along with a distal end of the anchor catheter52, extends into thepericardial space68. The inner dilator86 may be subsequently removed from theanchor catheter58, wherein the distal end of theanchor catheter58 remains extending into thepericardial space68.
• Illustrated inFIG. 12, the anchoringsystem50 of the present invention further comprises anoccluder device80 and anoccluder cable84. It is contemplated that theanchoring system50 of the present invention may be used with a diverse range ofLAA occluder devices80 such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples ofoccluder devices80 that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, theoccluder device80 may have a distal end with a hole approximately 1-5 mm in diameter. As shown inFIG. 12, theoccluder cable84 may be a hollow coaxial cable standardly used in the industry. Theoccluder cable84 may be attached to theoccluder device80, wherein theoccluder cable84 may be used for deploying and retrieving theoccluder device80 within theLAA64. Theoccluder device80 and theoccluder cable84 may encompass theanchor catheter58, wherein theanchor catheter58 may traverse through an inner lumen of theoccluder device80 and an inner lumen of theoccluder cable84. Theoccluder device80 may reside between theanchor catheter58 and theouter sheath56.
• As further shown inFIG. 12, the anchoringcatheter58 may comprise ananchor72 and ananchor cable82. Theanchor cable82 may be attached to theanchor72, wherein theanchor cable82 may be used for deploying theanchor72 within theLAA wall66. Theanchor cable82 may be a hollow coaxial cable standardly used in the industry. Theanchor cable82 andanchor72 may encompass thedelivery wire60, wherein thedelivery wire60 may traverse through an inner lumen of theanchor72 and an inner lumen of theanchor cable82. Thedelivery wire60 may be used to navigate theanchoring system50 through theLAA64. Alternatively, theanchor72 andanchor cable82 may be advanced through theanchor catheter58 into thepericardial space68 without using thedelivery wire60. Thebuddy wire62 may remain inside thepericardial space68 and is a safety feature in case of emergencies. Thebuddy wire62 allows an interventional cardiologist to advance another catheter through theLAA wall66 and place a plug within thesmall hole70 if a malfunction is observed with theanchor72 or theoccluder device80.
• Illustrated inFIG. 13, theanchor72 may be shaped like a sheave, comprising afirst half74, asecond half76, and ashaft78 connecting thefirst half74 to thesecond half76, although it is contemplated that other anchor shapes may also be utilized in the present invention. Theanchor72 may be comprised of wire, wherein thefirst half74 andsecond half76 of theanchor72 comprise wire mesh, further wherein theshaft78 may comprise a single wire connecting the first half75 wire mesh and thesecond half76 wire mesh. Theanchor72 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape, and may be comprised of single or multiple wires. Theanchor72 may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. Theanchor72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor72 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. Theanchor72 may have a lumen wherein thedelivery wire60 traverses therein, alternatively, theanchor72 may not have a lumen. Theanchor72 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
• Illustrated inFIGS. 13A-B, theanchor72 may have a contracted first position (FIG. 13A) and a deployed second position (FIG. 13B). In the contracted first position (FIG. 13A), thefirst half74,second half76, andshaft78 of theanchor72 have a diameter of approximately 1-5 mm and a length of approximately 5-55 mm. In the deployed second position (FIG. 13B), thefirst half74 andsecond half76 of theanchor72 may expand outwards a distance of approximately 5-25 mm in diameter, wherein theshaft78 remains approximately 1-5 mm in diameter. Theanchor72 may self-expand from the contracted first position (FIG. 13A) to the deployed second position (FIG. 13B).
• Illustrated inFIG. 14, theanchor72 in the contracted first position (FIG. 13A) may be advanced through theanchor catheter58 using theanchor cable82 and thedelivery wire60, wherein theanchor72 extends into thepericardial space68. Theanchor catheter58 may then be retracted, allowing thesecond half76 of theanchor72 to self-expand from the contracted first position to the deployed second position within thepericardial space68. While thesecond half76 of theanchor72 is in the deployed second position, theshaft78 and thefirst half74 of theanchor72 remain temporarily inside theanchor catheter58.
• Illustrated inFIG. 15, theanchor catheter58 may be further retracted, allowing thefirst half74 of theanchor72 to self-expand from the contracted first position to a partially deployed second position within theoccluder device80, wherein theoccluder device80 remains inside theouter sheath56. Theshaft78 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66. Thesecond half76 of theanchor72 remains in the deployed second position within thepericardial space68, wherein thefirst half74 of theanchor72 is in the partially deployed second position within theoccluder device80. Alternatively, theanchor72 andoccluder device80 may be integral, wherein theoccluder device80 may be a coil occluder device. Thus, theintegral anchor72 andoccluder device80 may be advanced together through theanchor catheter58, wherein theanchor72 is implanted in theLAA wall66 using thesystem50 of the present invention described above.
• Illustrated inFIG. 16, theouter sheath56 may be retracted to allow theoccluder device80 to expand inside theLAA64. Moreover, retracting theouter sheath56 allows thefirst half74 of theanchor72 to fully expand into the deployed second position within theoccluder device80. Thus, theshaft78 of theanchor72 may extend through the hole in the distal end of theoccluder device80, wherein the distal end of theoccluder device80 pinches down on theshaft78. Furthermore, the first half of theanchor74 in the deployed second position may pin theoccluder device80 against theLAA wall66, wherein theanchor72 effectively moors theoccluder device80 inside theLAA64. At this time the expandedanchor72 in the deployed second position covers a large surface area and therefore retains theoccluder device80 in an implanted position within theLAA64. Moreover, by anchoring theoccluder device80 via theanchor72 through all three layers of theLAA wall66—instead of merely latching onto the thin endocardium layer—theanchoring system50 of the present invention lowers the risk of embolization. Here, theanchor cable82 remains attached to theanchor72 and theoccluder cable84 remains attached to theoccluder device80 in case problems arise after deployment of theoccluder device80. If no problems arise and it is determined that theoccluder device80 is in an optimal location of theLAA64, theoccluder cable84 may be detached from theoccluder device80 and removed from theLAA64. Furthermore, theanchor cable82 may be detached from theanchor72 and removed from theLAA64. Thebuddy wire62 anddelivery wire60 may also be withdrawn from theLAA64, leaving theoccluder device80 anchored securely in theLAA64 by the anchoringsystem50 of the present invention.
• FIG. 17 illustrates theanchoring system50 of the present invention if problems arise after deployment of theoccluder device80. For instance, it may be determined that theoccluder device80 is not placed in an optimal location of theLAA64 after deployment to achieve maximum occlusion. In this situation—prior to release of theoccluder cable84 from theoccluder device80 and theanchor cable82 from theanchor72—theouter sheath56 may be advanced over theoccluder device80 to theLAA wall66, wherein theoccluder device80 is retracted inside theouter sheath56 using theoccluder cable82. Theanchor catheter58 may then be advanced to theLAA wall66, wherein thefirst half74 of theanchor72 is retracted inside theanchor catheter58 using theanchor cable82. Thus, using theanchor cable82, thefirst half74 of theanchor72 retracts from the deployed second position to the contracted first position to fit inside theanchor catheter58. Theouter sheath56 containing theoccluder device80 may then be removed from theLAA64, or theoccluder device80 may be re-deployed in a more optimal location of theLAA64. If theoccluder device80 is removed from theLAA64, theanchor catheter58 may be retrieved thereafter, allowing thefirst half74 of theanchor72 to expand from the contracted first position to the deployed second position within theLAA64. Thus, the deployedanchor72 remains inside theLAA64 and allows for occlusion of thesmall hole70 that was created by thepericardial catheter54 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66.
• Illustrated inFIG. 18, if optimal placement of theoccluder device80 was not achieved theanchor72 may be released from theanchor cable82 and deployed alone within theLAA wall66 to plug thesmall hole70 and prevent fluids from entering thepericardial space68. Thedelivery wire60 andbuddy wire62 may be subsequently removed from theLAA64. This allows for anew anchor72 to be placed within theLAA wall66 using theanchoring system50 cited above for achieving optimal placement of theoccluder device80 within theLAA64. On the other hand, if theanchor72 is initially placed in an optimal location within theLAA wall66 but there are problems with theoccluder device80, a second occluder device may be advanced over theinner sheath58 and deployed within theLAA64 using theanchoring system50 cited above. Thus, the anchoringsystem50 of the present invention allows an interventional cardiologist to quickly and cost-effectively implant theoccluder device80 into theLAA64 usinganchor72, safely retrieve or re-deploy theoccluder device80 if initial placement was improper or if complications arise, with an option to re-implant a new occluder device and new anchor in an optimal location of theLAA24. After optimal placement of theoccluder device80 within theLAA64 is achieved, thedelivery wire60 andbuddy wire62 may be removed from theLAA64.
• In another aspect of the present invention, ananchor72 is provided for anchoring anoccluder device80 within aLAA64. As illustrated inFIG. 13, theanchor72 may be shaped like a sheave, comprising afirst half74, asecond half76, and ashaft78 connecting thefirst half74 to thesecond half76, although it is contemplated that other anchor shapes may also be utilized in the present invention. Theanchor72 may be comprised of wire, wherein thefirst half74 andsecond half76 of theanchor72 comprise wire mesh, further wherein theshaft78 may comprise a single wire connecting the first half75 wire mesh and thesecond half76 wire mesh. Theanchor72 may further be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape, and may be comprised of single or multiple wires. Theanchor72 may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. Theanchor72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor72 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. Theanchor72 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
• Illustrated inFIGS. 13A-B, theanchor72 may have a contracted first position (FIG. 13A) and a deployed second position (FIG. 13B). In the contracted first position (FIG. 13A), thefirst half74,second half76, andshaft78 of theanchor72 have a diameter of approximately 1-5 mm and a length of approximately 5-55 mm. In the deployed second position (FIG. 13B), thefirst half74 andsecond half76 of theanchor72 may expand outwards a distance of approximately 5-25 mm in diameter, wherein theshaft78 remains approximately 1-5 mm in diameter. Theanchor72 may self-expand from the contracted first position (FIG. 13A) to the deployed second position (FIG. 13B).
• It is contemplated that theanchor72 of the present invention may be used with a diverse range ofLAA occluder devices80 such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples ofoccluder devices80 that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, theoccluder device80 may have a distal end with a hole approximately 1-5 mm in diameter.
• Illustrated inFIG. 14, theanchor72 in the contracted first position (FIG. 13A) may be advanced through ananchor catheter58 using ananchor cable82 and adelivery wire60, wherein theanchor72 extends intopericardial space68. Theanchor catheter58 may then be retracted, allowing thesecond half76 of theanchor72 to self-expand from the contracted first position to the deployed second position within thepericardial space68. While thesecond half76 of theanchor72 is in the deployed second position, theshaft72 and thefirst half74 of theanchor72 remain temporarily inside theanchor catheter58.
• Illustrated inFIG. 15, theanchor catheter58 may be further retracted, allowing thefirst half74 of theanchor72 to self-expand from the contracted first position to a partially deployed second position within theoccluder device80, wherein theoccluder device80 remains inside theouter sheath56. Theshaft78 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26. Thesecond half76 of theanchor72 remains in the deployed second position within thepericardial space68, wherein thefirst half74 of theanchor72 is in the partially deployed second position within theoccluder device80. Alternatively, theanchor72 andoccluder device80 may be integral, wherein theoccluder device80 may be a coil occluder device. Thus, theintegral anchor72 andoccluder device80 may be advanced together through theanchor catheter58, wherein theanchor72 is implanted in theLAA wall26 using thesystem50 of the present invention described above.
• Illustrated inFIG. 16, theouter sheath56 may be retracted to allow theoccluder device80 to expand inside theLAA64. Moreover, retracting theouter sheath56 allows thefirst half74 of theanchor72 to fully expand into the deployed second position within theoccluder device80. Thus, theshaft78 of theanchor72 may extend through the hole in the distal end of theoccluder device80, wherein the distal end of theoccluder device80 pinches down on theshaft78. Furthermore, the first half of theanchor74 in the deployed second position may pin theoccluder device80 against theLAA wall66, wherein theanchor72 effectively moors theoccluder device80 inside theLAA64. At this time the expandedanchor72 in the deployed second position covers a large surface area and therefore retains theoccluder device80 in an implanted position within theLAA64. Moreover, by anchoring theoccluder device80 via theanchor72 through all three layers of theLAA wall66—instead of merely latching onto the thin endocardium layer—theanchoring system50 of the present invention lowers the risk of embolization. Here, theanchor cable82 remains attached to theanchor72 and anoccluder cable84 remains attached to theoccluder device80 in case problems arise after deployment of theoccluder device80. If no problems arise and it is determined that theoccluder device80 is in an optimal location of theLAA64, theoccluder cable84 may be detached from theoccluder device80 and removed from theLAA64. Furthermore, theanchor cable82 may be detached from theanchor72 and removed from theLAA64. Thedelivery wire60 and/or abuddy wire62 may also be withdrawn from theLAA64, leaving theoccluder device80 anchored securely in theLAA64 by theanchor72 of the present invention.
• In yet another aspect of the present invention, a method of implanting and retrieving an occluder device within a LAA is illustrated inFIG. 10. The method of the present invention comprises providing ananchoring system50. The anchoringsystem50 may comprise apericardial catheter54, wherein thepericardial catheter54 may be a single or double-lumen pericardial catheter. The anchoringsystem50 may further comprise anouter sheath56. A balloon-occlusion catheter may also be utilized by the present invention. However, it is intended that other catheters standard in the industry may also be utilized. Thepericardial catheter54 may be configured to fit adelivery wire60 and/or abuddy wire62, also standardly used in the industry. A diameter of thedelivery wire60 may range between approximately 0.025-0.052 inches and a diameter of thebuddy wire62 may range between approximately 0.008-0.025 inches.
• Further illustrated inFIG. 10, the method of the present invention further comprises inserting theouter sheath56 into theLAA64 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude theLAA64 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of theouter sheath56 within theLAA64 and allow for better imaging of theLAA64 by an interventional cardiologist. Thepericardial catheter54 may be advanced through theouter sheath56 to theLAA wall66. Thebuddy wire62 is next advanced through thepericardial catheter54 and theadjacent LAA wall66, wherein thebuddy wire62 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall26 to extend into thepericardial space68. Thepericardial catheter54 is advanced over thebuddy wire62 and through theLAA wall66, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66 to extend into thepericardial space68. Thus, thepericardial catheter54 creates asmall hole70 through theLAA wall66 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within thepericardial space68 via thesmall hole70. While thepericardial catheter54 remains inside thepericardial space68 via thesmall hole70, thedelivery wire60 may then be advanced through thepericardial catheter54, wherein thedelivery wire60 enters thepericardial space68. Thepericardial catheter54 may then be removed from theouter sheath56, leaving thedelivery wire60 and thebuddy wire62 inside thepericardial space68 via thesmall hole70 in theLAA wall66.
• Illustrated inFIG. 11, the method of the present invention further comprises providing ananchor catheter58 and an inner dilator86, wherein the inner dilator86 includes a pointeddistal end88. The inner dilator86 may be configured to encompass thedelivery wire60, wherein thedelivery wire60 may traverse through an inner lumen of the inner dilator86. Theanchor catheter58 and the inner dilator86 may be advanced through theouter sheath56 to theLAA wall66 adjacent thesmall hole70. Particularly, thedelivery wire60 may traverse through the anchor catheter52 and the inner dilator86. Thebuddy wire62 may reside outside theanchor catheter58 and yet inside theouter sheath56. Using the pointeddistal end88 of the inner dilator86, the inner dilator86 and the anchor catheter52 may be further advanced through thesmall hole70 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66. Thus, the pointeddistal end88 of the inner dilator86, along with a distal end of the anchor catheter52, extends into thepericardial space68. The inner dilator86 may be subsequently removed from theanchor catheter58, wherein the distal end of theanchor catheter58 remains extending into thepericardial space68.
• Illustrated inFIG. 12, the method of the present invention further comprises providing anoccluder device80 and anoccluder cable84. It is contemplated that the method of the present invention may be used with a diverse range ofLAA occluder devices80 such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples ofoccluder devices80 that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, theoccluder device80 may have a distal end with a hole approximately 1-5 mm in diameter. As shown inFIG. 12, theoccluder cable84 may be a hollow coaxial cable standardly used in the industry. Theoccluder cable84 may be attached to theoccluder device80, wherein theoccluder cable84 may be used for deploying and retrieving theoccluder device80 within theLAA64. Theoccluder device80 and theoccluder cable84 may encompass theanchor catheter58, wherein theanchor catheter58 may traverse through an inner lumen of theoccluder device80 and an inner lumen of theoccluder cable84. Theoccluder device80 may reside between theanchor catheter58 and theouter sheath56.
• As further shown inFIG. 12, the method of the present invention further comprises providing ananchor72 and ananchor cable82, wherein theanchor72 andanchor cable82 are inserted in theanchor catheter58. Theanchor cable82 may be attached to theanchor72, wherein theanchor cable82 may be used for deploying theanchor72 within theLAA wall66. Theanchor cable82 may be a hollow coaxial cable standardly used in the industry. Theanchor cable82 andanchor72 may encompass thedelivery wire60, wherein thedelivery wire60 may traverse through an inner lumen of theanchor72 and an inner lumen of theanchor cable82. Thedelivery wire60 may be used to navigate theanchoring system50 through theLAA64. Alternatively, theanchor72 andanchor cable82 may be advanced through theanchor catheter58 into thepericardial space68 without using thedelivery wire60. Thebuddy wire62 may remain inside thepericardial space68 and is a safety feature in case of emergencies. Thebuddy wire62 allows an interventional cardiologist to advance another catheter through theLAA wall66 and place a plug within thesmall hole70 if a malfunction is observed with theanchor72 or theoccluder device80.
• Illustrated inFIG. 13, theanchor72 may be shaped like a sheave, comprising afirst half74, asecond half76, and ashaft78 connecting thefirst half74 to thesecond half76, although it is contemplated that other anchor shapes may also be utilized in the present invention. Theanchor72 may be comprised of wire, wherein thefirst half74 andsecond half76 of theanchor72 comprise wire mesh, further wherein theshaft78 may comprise a single wire connecting the first half75 wire mesh and thesecond half76 wire mesh. Theanchor72 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape, and may be comprised of single or multiple wires. Theanchor72 may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. Theanchor72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor72 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. Theanchor72 may have a lumen wherein thedelivery wire60 traverses therein, alternatively, theanchor72 may not have a lumen. Theanchor72 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
• Illustrated inFIGS. 13A-B, theanchor72 may have a contracted first position (FIG. 13A) and a deployed second position (FIG. 13B). In the contracted first position (FIG. 13A), thefirst half74,second half76, andshaft78 of theanchor72 have a diameter of approximately 1-5 mm and a length of approximately 5-55 mm. In the deployed second position (FIG. 13B), thefirst half74 andsecond half76 of theanchor72 may expand outwards a distance of approximately 5-25 mm in diameter, wherein theshaft78 remains approximately 1-5 mm in diameter. Theanchor72 may self-expand from the contracted first position (FIG. 13A) to the deployed second position (FIG. 13B).
• Illustrated inFIG. 14, the method of the present invention comprises advancing theanchor72 in the contracted first position (FIG. 13A) through theanchor catheter58 using theanchor cable82 and thedelivery wire60, wherein theanchor72 extends into thepericardial space68. Theanchor catheter58 may then be retracted, allowing thesecond half76 of theanchor72 to self-expand from the contracted first position to the deployed second position within thepericardial space68. While thesecond half76 of theanchor72 is in the deployed second position, theshaft78 and thefirst half74 of theanchor72 remain temporarily inside theanchor catheter58.
• Illustrated inFIG. 15, the method of the present invention further comprises retracting theanchor catheter58, allowing thefirst half74 of theanchor72 to self-expand from the contracted first position to a partially deployed second position within theoccluder device80, wherein theoccluder device80 remains inside theouter sheath56. Theshaft78 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66. Thesecond half76 of theanchor72 remains in the deployed second position within thepericardial space68, wherein thefirst half74 of theanchor72 is in the partially deployed second position within theoccluder device80. Alternatively, theanchor72 andoccluder device80 may be integral, wherein theoccluder device80 may be a coil occluder device. Thus, theintegral anchor72 andoccluder device80 may be advanced together through theanchor catheter58, wherein theanchor72 is implanted in theLAA wall66 using thesystem50 of the present invention described above.
• Illustrated inFIG. 16, the method of the present invention comprises retracting theouter sheath56 to allow theoccluder device80 to expand inside theLAA64. Moreover, retracting theouter sheath56 allows thefirst half74 of theanchor72 to fully expand into the deployed second position within theoccluder device80. Thus, theshaft78 of theanchor72 may extend through the hole in the distal end of theoccluder device80, wherein the distal end of theoccluder device80 pinches down on theshaft78. Furthermore, the first half of theanchor74 in the deployed second position may pin theoccluder device80 against theLAA wall66, wherein theanchor72 effectively moors theoccluder device80 inside theLAA64. At this time the expandedanchor72 in the deployed second position covers a large surface area and therefore retains theoccluder device80 in an implanted position within theLAA64. Moreover, by anchoring theoccluder device80 via theanchor72 through all three layers of theLAA wall66—instead of merely latching onto the thin endocardium layer—the method of the present invention lowers the risk of embolization. Here, theanchor cable82 remains attached to theanchor72 and theoccluder cable84 remains attached to theoccluder device80 in case problems arise after deployment of theoccluder device80. If no problems arise and it is determined that theoccluder device80 is in an optimal location of theLAA64, theoccluder cable84 may be detached from theoccluder device80 and removed from theLAA64. Furthermore, theanchor cable82 may be detached from theanchor72 and removed from theLAA64. Thebuddy wire62 anddelivery wire60 may also be withdrawn from theLAA64, leaving theoccluder device80 anchored securely in theLAA64 by the method of the present invention.
• FIG. 17 illustrates the method of the present invention if problems arise after deployment of theoccluder device80. For instance, the method comprises making a determination that theoccluder device80 is not placed in an optimal location of theLAA64 after deployment to achieve maximum occlusion. In this situation—prior to release of theoccluder cable84 from theoccluder device80 and theanchor cable82 from theanchor72—theouter sheath56 may be advanced over theoccluder device80 to theLAA wall66, wherein theoccluder device80 is retracted inside theouter sheath56 using theoccluder cable82. Theanchor catheter58 may then be advanced to theLAA wall66, wherein thefirst half74 of theanchor72 is retracted inside theanchor catheter58 using theanchor cable82. Thus, using theanchor cable82, thefirst half74 of theanchor72 retracts from the deployed second position to the contracted first position to fit inside theanchor catheter58. Theouter sheath56 containing theoccluder device80 may then be removed from theLAA64, or theoccluder device80 may be re-deployed in a more optimal location of theLAA64. If theoccluder device80 is removed from theLAA64, theanchor catheter58 may be retrieved thereafter, allowing thefirst half74 of theanchor72 to expand from the contracted first position to the deployed second position within theLAA64. Thus, the deployedanchor72 remains inside theLAA64 and allows for occlusion of thesmall hole70 that was created by thepericardial catheter54 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall66.
• Illustrated inFIG. 18, if a determination is made that optimal placement of theanchor72 was not achieved, theanchor72 may be released from theanchor cable82 and deployed alone within theLAA wall66 to plug thesmall hole70 and prevent fluids from entering thepericardial space68. Thedelivery wire60 andbuddy wire62 may be subsequently removed from theLAA64. This allows for anew anchor72 to be placed within theLAA wall66 using the method cited above for achieving optimal placement of theoccluder device80 within theLAA64. On the other hand, if a determination is made that theanchor72 is initially placed in an optimal location within theLAA wall66 but there are problems with theoccluder device80, a second occluder device may be advanced over theinner sheath58 and deployed within theLAA64 using the method cited above. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant theoccluder device80 into theLAA64 usinganchor72, safely retrieve or re-deploy theoccluder device80 if initial placement was improper or if complications arise, with an option to re-implant a new occluder device and new anchor in an optimal location of theLAA24. After optimal placement of theoccluder device80 within theLAA64 is achieved, thedelivery wire60 andbuddy wire62 may be removed from theLAA64.
• FIG. 19 illustrates yet a further aspect of the present invention, ananchoring system90 for implanting and retrieving an occluder device within a LAA. The anchoringsystem90 may comprise apericardial catheter94, wherein thepericardial catheter94 may be a single or double-lumen pericardial catheter. The anchoringsystem90 may further comprise anouter sheath96 and aninner sheath98. A balloon-occlusion catheter may also be utilized by the present invention. However, it is intended that other catheters standard in the industry may also be utilized. Thepericardial catheter94 may be configured to fit adelivery wire100 and/or abuddy wire102, also standardly used in the industry. A diameter of thedelivery wire100 may range between approximately 0.025-0.052 inches and a diameter of thebuddy wire102 may range between approximately 0.008-0.025 inches.
• Further shown inFIG. 19, theouter sheath96 may be inserted intoLAA104 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure to aLAA wall106. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude theLAA104 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of theouter sheath96 within theLAA104 and allow for better imaging of theLAA104 by an interventional cardiologist. Thepericardial catheter94 may be advanced through theouter sheath96 to theLAA wall106. Thebuddy wire102 is next advanced through thepericardial catheter94 and theadjacent LAA wall106, wherein thebuddy wire102 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend into thepericardial space108. Thepericardial catheter94 is next advanced over thebuddy wire104 and through theLAA wall106, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend into thepericardial space108. Thus, thepericardial catheter94 creates asmall hole110 through theLAA wall106 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within thepericardial space108 via thesmall hole110. While thepericardial catheter94 remains inside thepericardial space108 via thesmall hole110, thedelivery wire100 may then be advanced through thepericardial catheter94, wherein thedelivery wire100 enters thepericardial space108. Thepericardial catheter94 may then be removed from theouter sheath96, leaving thedelivery wire100 and thebuddy wire102 inside thepericardial space108 via thesmall hole110 in theLAA wall106.
• Illustrated inFIG. 20, the anchoringsystem90 of the present invention further comprises anoccluder device120 and anoccluder cable124. It is contemplated that theanchoring system90 of the present invention may be used with a diverse range ofLAA occluder devices120 such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples ofoccluder devices120 that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, theoccluder device120 may have a distal end with a hole approximately 1-5 mm in diameter.
• As shown inFIG. 20, theoccluder cable124 may be a hollow coaxial cable standardly used in the industry. Theoccluder cable124 may be attached to theoccluder device120, wherein theoccluder cable124 may be used for deploying and retrieving theoccluder device120 within theLAA104. Theoccluder device120 and theoccluder cable124 may encompass theinner sheath98, wherein theinner sheath98 may traverse through an inner lumen of theoccluder device120 and an inner lumen of theoccluder cable124. Theoccluder device120 may reside between theinner sheath98 and theouter sheath96.
• As further shown inFIG. 20, theinner sheath98 may be advanced through theouter sheath96 to theLAA wall106 adjacent thesmall hole110. Particularly, thedelivery wire100 may traverse through theinner sheath98, theoccluder device120, and theoccluder cable124. Thebuddy wire102 may reside outside theinner sheath98 and yet inside theouter sheath96.
• As also shown inFIG. 20, theinner sheath98 may comprise ananchor112 and ananchor cable122. Theanchor cable122 may be attached to theanchor112, wherein theanchor cable122 may be used for deploying theanchor112 within theLAA wall106. Theanchor cable122 may be a hollow coaxial cable standardly used in the industry. Theanchor cable122 andanchor112 may encompass thedelivery wire100, wherein thedelivery wire100 may traverse through an inner lumen of theanchor112 and an inner lumen of theanchor cable122. Thedelivery wire100 may be used to navigate theanchoring system90 through theLAA104. Alternatively, theanchor112 andanchor cable122 may be advanced through theinner sheath98 into thepericardial space108 without using thedelivery wire100. Thebuddy wire102 may remain inside thepericardial space108 and is a safety feature in case of emergencies. Thebuddy wire102 allows an interventional cardiologist to advance another catheter through theLAA wall106 and place a plug within thesmall hole110 if a malfunction is observed with theanchor112 or theoccluder device120.
• Illustrated inFIGS. 21A and 21B, theanchor112 may have an elongate contracted first position (FIG. 21A) (e.g., straight—coil) when thedelivery wire100 is traversing the inner lumen of theanchor112, and a deployed second position (FIG. 21B) (e.g., double-coil) when thedelivery wire100 has been removed from the inner lumen of theanchor112. Thedelivery wire100 when inside the inner lumen of theanchor112 straightens theanchor112 from its natural coiled state (deployed second position) into the elongated straight-coil (contracted first position). In the contracted first position (FIG. 21A), theanchor112 has a diameter of approximately 0.5-2 mm and a length of approximately 2-40 mm. In the deployed second position (FIG. 21B), theanchor112 may comprise afirst coil114, asecond coil116, wherein thefirst coil114 andsecond coil116 are connected together by ashaft118. In the deployed second position (FIG. 21B), thefirst coil114 andsecond coil116 expand outwards a distance of approximately 5-15 mm in diameter, theshaft118 remains approximately 0.5-2 mm in diameter, wherein the total length of theanchor112 is approximately 1-10 mm. Theanchor112 may self-expand from the contracted first position (FIG. 21A) to the deployed second position (FIG. 21B).
• Illustrated inFIG. 21B, thefirst coil114 andsecond coil116 of theanchor112 may be shaped like circular disks, although it is contemplated that other anchor shapes may also be utilized in the present invention. For instance, the anchor coils114,116 may comprise a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. Theanchor112 may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. Theanchor112 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor112 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. Theanchor112 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
• Illustrated inFIG. 22, theanchor112 in the contracted first position (FIG. 21A) may be advanced through theinner sheath98 using theanchor cable122 and thedelivery wire100, wherein theanchor112 is further advanced through thesmall hole110 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend into thepericardial space68. Thedelivery wire100 may then be retracted, allowing thesecond coil116 of theanchor112 to self-expand from the contracted first position to the deployed second position within thepericardial space108. While thesecond coil116 of theanchor112 is in the deployed second position, theshaft118 and thefirst coil114 of theanchor112 remain temporarily in the contracted first position.
• Illustrated inFIG. 23, theinner sheath98 adjacent theLAA wall106 may be retracted along with thedelivery wire100, allowing thefirst coil114 of theanchor112 to self-expand from the contracted first position to a partially deployed second position within theoccluder device120. Theoccluder device120 remains inside theouter sheath96 adjacent theLAA wall106. Theshaft118 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106. Thesecond coil116 of theanchor112 remains in the deployed second position within thepericardial space108, wherein thefirst coil114 of theanchor112 is in the partially deployed second position within theoccluder device120. Alternatively, theanchor112 andoccluder device120 may be integral, wherein theoccluder device120 may be a coil occluder device. Thus, theintegral anchor112 andoccluder device120 may be advanced together through theinner sheath98, wherein theanchor112 is implanted in theLAA wall106 using thesystem90 of the present invention described above.
• Illustrated inFIG. 24, theouter sheath96 may be retracted to allow theoccluder device120 to expand inside theLAA104. Moreover, retracting theouter sheath96 allows thefirst coil114 of theanchor112 to fully expand into the deployed second position within theoccluder device120. Thus, theshaft118 of theanchor112 may extend through the hole in the distal end of theoccluder device120, wherein the distal end of theoccluder device120 pinches down on theshaft118. Furthermore, thefirst coil114 of theanchor112 in the deployed second position may pin theoccluder device120 against theLAA wall106, wherein theanchor112 effectively moors theoccluder device120 inside theLAA104. At this time the expandedanchor112 in the deployed second position covers a large surface area and therefore retains theoccluder device120 in an implanted position within theLAA104. Moreover, by anchoring theoccluder device120 via theanchor112 through all three layers of theLAA wall106—instead of merely latching onto the thin endocardium layer—theanchoring system90 of the present invention lowers the risk of embolization. Thesecond coil116 located within thepericardial space108 may unwind in a clockwise fashion, while thefirst coil114 located in theLAA104 may unwind in an reverse-clockwise fashion. Thus, there would be counter-forces acting on the coils, wherein thesecond coil116 exerts proximal traction and thefirst coil114 exerts distal traction against opposite sides of theLAA wall106. Such counter-forces discourage theanchor112 from unraveling while in the deployed second position within theLAA wall106.
• Theanchor cable122 remains attached to theanchor112 and theoccluder cable124 remains attached to theoccluder device120 in case problems arise after deployment of theoccluder device120. If no problems arise and it is determined that theoccluder device120 is in an optimal location of theLAA104, theoccluder cable124 may be detached from theoccluder device120 and removed from theLAA104. Furthermore, theanchor cable122 may be detached from theanchor112 and removed from theLAA104. Thebuddy wire102 anddelivery wire100 may also be withdrawn from theLAA106, leaving theoccluder device120 anchored securely in theLAA104 by the anchoringsystem90 of the present invention.
• FIG. 25 illustrates theanchoring system90 of the present invention if problems arise after deployment of theoccluder device120. For instance, it may be determined that theoccluder device120 is not placed in an optimal location of theLAA104 after deployment to achieve maximum occlusion. In this situation—prior to release of theoccluder cable124 from theoccluder device120 and theanchor cable122 from theanchor112—theouter sheath96 may be advanced over theoccluder device120, wherein theoccluder device120 is retracted inside theouter sheath96 using theoccluder cable124. Thedelivery wire100 may be further advanced through theanchor cable112 andfirst coil114 of theanchor112, wherein thefirst coil114 retracts from the deployed second position to the contracted first position and may be retrieved inside theinner sheath98. Theouter sheath96 containing theoccluder device120 may then be removed from theLAA104, or theoccluder device120 may be re-deployed in a more optimal location of theLAA104. If theoccluder device120 is removed from theLAA104, thedelivery wire100 may be retrieved thereafter, allowing thefirst coil114 of theanchor112 to re-expand from the contracted first position to the deployed second position within theLAA104. Thus, the deployedanchor112 remains inside theLAA104 and allows for occlusion of thesmall hole110 that was created by thepericardial catheter94 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106.
• Illustrated inFIG. 26, if optimal placement of theoccluder device120 was not achieved theanchor112 may be released from theanchor cable122 and deployed alone within theLAA wall106. This allows for anew anchor112 to be placed within theLAA wall106 using theanchoring system90 cited above for achieving optimal placement of theoccluder device120 within theLAA104. On the other hand, if theanchor112 is initially placed in an optimal location within theLAA wall106 but there are problems with theoccluder device120, a second occluder device may be advanced using theinner sheath98 and deployed within theLAA104 using theanchoring system90 cited above. Thus, the anchoringsystem90 of the present invention allows an interventional cardiologist to quickly and cost-effectively implant theoccluder device120 into theLAA104 usinganchor112, safely retrieve or re-deploy theoccluder device120 if initial placement was improper or if complications arise, with an option to re-implant a new occluder device and new anchor in an optimal location of theLAA104. After optimal placement of theoccluder device120 within theLAA104 is achieved, thedelivery wire100 and thebuddy wire102 may be removed from theLAA104.
• In another aspect of the present invention, ananchor112 is provided for anchoring anoccluder device120 within aLAA104. As illustrated inFIGS. 21A and 21B, theanchor112 may have an elongate contracted first position (FIG. 21A) (e.g., straight—coil) when adelivery wire100 is traversing an inner lumen of theanchor112, and a deployed second position (FIG. 21B) (e.g., double-coil) when thedelivery wire100 has been removed from the inner lumen of theanchor112. Thedelivery wire100 when inside the inner lumen of theanchor112 straightens theanchor112 from its natural coiled state (deployed second position) into the elongated straight-coil (contracted first position). In the contracted first position (FIG. 21A), theanchor112 has a diameter of approximately 0.5-2 mm and a length of approximately 2-40 mm. In the deployed second position (FIG. 21B), theanchor112 may comprise afirst coil114, asecond coil116, wherein thefirst coil114 andsecond coil116 are connected together by ashaft118. In the deployed second position (FIG. 21B), thefirst coil114 andsecond coil116 expand outwards a distance of approximately 5-15 mm in diameter, theshaft118 remains approximately 0.5-2 mm in diameter, wherein the total length of theanchor112 is approximately 1-10 mm. Theanchor112 may self-expand from the contracted first position (FIG. 21A) to the deployed second position (FIG. 21B).
• Illustrated inFIG. 21B, thefirst coil114 andsecond coil116 of theanchor112 may be shaped like circular disks, although it is contemplated that other anchor shapes may also be utilized in the present invention. For instance, the anchor coils114,116 may comprise a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. Theanchor112 may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. Theanchor112 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor112 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. Theanchor112 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
• It is contemplated that theanchor112 of the present invention may be used with a diverse range ofLAA occluder devices120 such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples ofoccluder devices120 that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, theoccluder device120 may have a distal end with a hole approximately 1-5 mm in diameter.
• Illustrated inFIG. 22, theanchor112 in the contracted first position (FIG. 21A) may be advanced through aninner sheath98 using ananchor cable122 and thedelivery wire100, wherein theanchor112 is further advanced through asmall hole110 in anLAA wall106 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend intopericardial space68. Thedelivery wire100 may then be retracted, allowing thesecond coil116 of theanchor112 to self-expand from the contracted first position to the deployed second position within thepericardial space108. While thesecond coil116 of theanchor112 is in the deployed second position, theshaft118 and thefirst coil114 of theanchor112 remain temporarily in the contracted first position.
• Illustrated inFIG. 23, theinner sheath98 adjacent theLAA wall106 may be retracted along with thedelivery wire100, allowing thefirst coil114 of theanchor112 to self-expand from the contracted first position to a partially deployed second position within theoccluder device120. Theoccluder device120 remains inside anouter sheath96 adjacent theLAA wall106. Theshaft118 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106. Thesecond coil116 of theanchor112 remains in the deployed second position within thepericardial space108, wherein thefirst coil114 of theanchor112 is in the partially deployed second position within theoccluder device120. Alternatively, theanchor112 andoccluder device120 may be integral, wherein theoccluder device120 may be a coil occluder device. Thus, theintegral anchor112 andoccluder device120 may be advanced together through theinner sheath98, wherein theanchor112 is implanted in theLAA wall106 using thesystem90 of the present invention described above.
• Illustrated inFIG. 24, theouter sheath96 may be retracted to allow theoccluder device120 to expand inside theLAA104. Moreover, retracting theouter sheath96 allows thefirst coil114 of theanchor112 to fully expand into the deployed second position within theoccluder device120. Thus, theshaft118 of theanchor112 may extend through the hole in the distal end of theoccluder device120, wherein the distal end of theoccluder device120 pinches down on theshaft118. Furthermore, thefirst coil114 of theanchor112 in the deployed second position may pin theoccluder device120 against theLAA wall106, wherein theanchor112 effectively moors theoccluder device120 inside theLAA104. At this time the expandedanchor112 in the deployed second position covers a large surface area and therefore retains theoccluder device120 in an implanted position within theLAA104. Moreover, by anchoring theoccluder device120 via theanchor112 through all three layers of theLAA wall106—instead of merely latching onto the thin endocardium layer—theanchoring system90 of the present invention lowers the risk of embolization. Thesecond coil116 located within thepericardial space108 may unwind in a clockwise fashion, while thefirst coil114 located in theLAA104 may unwind in an reverse-clockwise fashion. Thus, there would be counter-forces acting on the coils, wherein thesecond coil116 exerts proximal traction and thefirst coil114 exerts distal traction against opposite sides of theLAA wall106. Such counter-forces discourage theanchor112 from unraveling while in the deployed second position within theLAA wall106.
• Theanchor cable122 remains attached to theanchor112 and anoccluder cable124 remains attached to theoccluder device120 in case problems arise after deployment of theoccluder device120. If no problems arise and it is determined that theoccluder device120 is in an optimal location of theLAA104, theoccluder cable124 may be detached from theoccluder device120 and removed from theLAA104. Furthermore, theanchor cable122 may be detached from theanchor112 and removed from theLAA104. Thedelivery wire100 and/or abuddy wire102 may also be withdrawn from theLAA106, leaving theoccluder device120 anchored securely in theLAA104 by the anchoringsystem90 of the present invention.
• In yet another aspect of the present invention, a method of implanting and retrieving an occluder device within a LAA is illustrated inFIG. 19. The method of the present invention comprises providing ananchoring system90. The anchoringsystem90 may comprise apericardial catheter94, wherein thepericardial catheter94 may be a single or double-lumen pericardial catheter. The anchoringsystem90 may further comprise anouter sheath96 and aninner sheath98. A balloon-occlusion catheter may also be utilized by the present invention. However, it is intended that other catheters standard in the industry may also be utilized. Thepericardial catheter94 may be configured to fit adelivery wire100 and/or abuddy wire102, also standardly used in the industry. A diameter of thedelivery wire100 may range between approximately 0.025-0.052 inches and a diameter of thebuddy wire102 may range between approximately 0.008-0.025 inches.
• Further shown inFIG. 19, the method of the present invention further comprises inserting theouter sheath96 intoLAA104 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure to theLAA wall106. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude theLAA104 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of theouter sheath96 within theLAA104 and allow for better imaging of theLAA104 by an interventional cardiologist. Thepericardial catheter94 may be advanced through theouter sheath96 to theLAA wall106. Thebuddy wire102 is next advanced through thepericardial catheter94 and theadjacent LAA wall106, wherein thebuddy wire102 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend into thepericardial space108. Thepericardial catheter94 is next advanced over thebuddy wire104 and through theLAA wall106, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend into thepericardial space108. Thus, thepericardial catheter94 creates asmall hole110 through theLAA wall106 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within thepericardial space108 via thesmall hole110. While thepericardial catheter94 remains inside thepericardial space108 via thesmall hole110, thedelivery wire100 may then be advanced through thepericardial catheter94, wherein thedelivery wire100 enters thepericardial space108. Thepericardial catheter94 may then be removed from theouter sheath96, leaving thedelivery wire100 and thebuddy wire102 inside thepericardial space108 via thesmall hole110 in theLAA wall106.
• Illustrated inFIG. 20, the method of the present invention further comprises providing anoccluder device120 and anoccluder cable124. It is contemplated that the method of the present invention may be used with a diverse range ofLAA occluder devices120 such as coil implants, foam plugs, expandable frames, combinations thereof, and other occluder devices currently used in the industry and/or to be developed in the future. Specific examples ofoccluder devices120 that may be used by the present invention include, but are not limited to, WATCHMAN®, ATRICLIP®, PLAATO LAA Occlusion System®, AMPLATZER™, and AMULET™. In the present invention, theoccluder device120 may have a distal end with a hole approximately 1-5 mm in diameter.
• As shown inFIG. 20, theoccluder cable124 may be a hollow coaxial cable standardly used in the industry. Theoccluder cable124 may be attached to theoccluder device120, wherein theoccluder cable124 may be used for deploying and retrieving theoccluder device120 within theLAA104. Theoccluder device120 and theoccluder cable124 may encompass theinner sheath98, wherein theinner sheath98 may traverse through an inner lumen of theoccluder device120 and an inner lumen of theoccluder cable124. Theoccluder device120 may reside between theinner sheath98 and theouter sheath96.
• As further shown inFIG. 20, the method of the present invention comprises advancing theinner sheath98 through theouter sheath96 to theLAA wall106 adjacent thesmall hole110. Particularly, thedelivery wire100 may traverse through theinner sheath98, theoccluder device120, and theoccluder cable124. Thebuddy wire102 may reside outside theinner sheath98 and yet inside theouter sheath96.
• Also shown inFIG. 20, the method of the present invention further comprises providing ananchor112 and ananchor cable122. Theanchor cable122 may be attached to theanchor112, wherein theanchor cable122 may be used for deploying theanchor112 within theLAA wall106. Theanchor cable122 may be a hollow coaxial cable standardly used in the industry. Theanchor cable122 andanchor112 may encompass thedelivery wire100, wherein thedelivery wire100 may traverse through an inner lumen of theanchor112 and an inner lumen of theanchor cable122. Thedelivery wire100 may be used to navigate theanchoring system90 through theLAA104. Alternatively, theanchor112 andanchor cable122 may be advanced through theinner sheath98 into thepericardial space108 without using thedelivery wire100. Thebuddy wire102 may remain inside thepericardial space108 and is a safety feature in case of emergencies. Thebuddy wire102 allows an interventional cardiologist to advance another catheter through theLAA wall106 and place a plug within thesmall hole110 if a malfunction is observed with theanchor112 or theoccluder device120.
• Illustrated inFIGS. 21A and 21B, theanchor112 may have an elongate contracted first position (FIG. 21A) (e.g., straight—coil) when thedelivery wire100 is traversing the inner lumen of theanchor112, and a deployed second position (FIG. 21B) (e.g., double-coil) when thedelivery wire100 has been removed from the inner lumen of theanchor112. Thedelivery wire100 when inside the inner lumen of theanchor112 straightens theanchor112 from its natural coiled state (deployed second position) into the elongated straight-coil (contracted first position). In the contracted first position (FIG. 21A), theanchor112 has a diameter of approximately 0.5-2 mm and a length of approximately 2-40 mm. In the deployed second position (FIG. 21B), theanchor112 may comprise afirst coil114, asecond coil116, wherein thefirst coil114 andsecond coil116 are connected together by ashaft118. In the deployed second position (FIG. 21B), thefirst coil114 andsecond coil116 expand outwards a distance of approximately 5-15 mm in diameter, theshaft118 remains approximately 0.5-2 mm in diameter, wherein the total length of theanchor112 is approximately 1-10 mm. Theanchor112 may self-expand from the contracted first position (FIG. 21A) to the deployed second position (FIG. 21B).
• Illustrated inFIG. 21B, thefirst coil114 andsecond coil116 of theanchor112 may be shaped like circular disks, although it is contemplated that other anchor shapes may also be utilized in the method of the present invention. For instance, the anchor coils114,116 may comprise a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. Theanchor112 may be circular in diameter, however, it is contemplated that other cross-sectional shapes may also be utilized, including but not limited to, square, rectangular, triangular, pentagonal, and octagonal depending on the manufacturing technique. Theanchor112 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. Theanchor112 may also comprise antibiotics, drugs that prevent the LAA pericardium wall from bleeding, ePTFE, any variety of materials which facilitate cellular in-growth, hydrogel, anticoagulants, fibrin hairs and/or other pharmaceuticals. Theanchor112 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
• Illustrated inFIG. 22, the method of the present invention comprises advancing theanchor112 in the contracted first position (FIG. 21A) through theinner sheath98 using theanchor cable122 and thedelivery wire100, wherein theanchor112 is further advanced through thesmall hole110 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106 to extend into thepericardial space68. Thedelivery wire100 may then be retracted, allowing thesecond coil116 of theanchor112 to self-expand from the contracted first position to the deployed second position within thepericardial space108. While thesecond coil116 of theanchor112 is in the deployed second position, theshaft118 and thefirst coil114 of theanchor112 remain temporarily in the contracted first position.
• Illustrated inFIG. 23, the method of the present invention comprises retracting theinner sheath98 adjacent theLAA wall106, along with thedelivery wire100, to allow thefirst coil114 of theanchor112 to self-expand from the contracted first position to a partially deployed second position within theoccluder device120. Theoccluder device120 remains inside theouter sheath96 adjacent theLAA wall106. Theshaft118 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106. Thesecond coil116 of theanchor112 remains in the deployed second position within thepericardial space108, wherein thefirst coil114 of theanchor112 is in the partially deployed second position within theoccluder device120. Alternatively, theanchor112 andoccluder device120 may be integral, wherein theoccluder device120 may be a coil occluder device. Thus, theintegral anchor112 andoccluder device120 may be advanced together through theinner sheath98, wherein theanchor112 is implanted in theLAA wall106 using thesystem90 of the present invention described above.
• Illustrated inFIG. 24, the method of the present invention comprises retracting theouter sheath96 to allow theoccluder device120 to expand inside theLAA104. Moreover, retracting theouter sheath96 allows thefirst coil114 of theanchor112 to fully expand into the deployed second position within theoccluder device120. Thus, theshaft118 of theanchor112 may extend through the hole in the distal end of theoccluder device120, wherein the distal end of theoccluder device120 pinches down on theshaft118. Furthermore, thefirst coil114 of theanchor112 in the deployed second position may pin theoccluder device120 against theLAA wall106, wherein theanchor112 effectively moors theoccluder device120 inside theLAA104. At this time the expandedanchor112 in the deployed second position covers a large surface area and therefore retains theoccluder device120 in an implanted position within theLAA104. Moreover, by anchoring theoccluder device120 via theanchor112 through all three layers of theLAA wall106—instead of merely latching onto the thin endocardium layer—the method of the present invention lowers the risk of embolization. Thesecond coil116 located within thepericardial space108 may unwind in a clockwise fashion, while thefirst coil114 located in theLAA104 may unwind in an reverse-clockwise fashion. Thus, there would be counter-forces acting on the coils, wherein thesecond coil116 exerts proximal traction and thefirst coil114 exerts distal traction against opposite sides of theLAA wall106. Such counter-forces discourage theanchor112 from unraveling while in the deployed second position within theLAA wall106.
• Theanchor cable122 remains attached to theanchor112 and theoccluder cable124 remains attached to theoccluder device120 in case problems arise after deployment of theoccluder device120. If no problems arise and a determination is made that theoccluder device120 is in an optimal location of theLAA104, theoccluder cable124 may be detached from theoccluder device120 and removed from theLAA104. Furthermore, theanchor cable122 may be detached from theanchor112 and removed from theLAA104. Thebuddy wire102 anddelivery wire100 may also be withdrawn from theLAA106, leaving theoccluder device120 anchored securely in theLAA104 by the method of the present invention.
• FIG. 25 illustrates the method of the present invention if problems arise after deployment of theoccluder device120. For instance, the method comprises making a determination that theoccluder device120 is not placed in an optimal location of theLAA104 after deployment to achieve maximum occlusion. In this situation—prior to release of theoccluder cable124 from theoccluder device120 and theanchor cable122 from theanchor112—theouter sheath96 may be advanced over theoccluder device120, wherein theoccluder device120 is retracted inside theouter sheath96 using theoccluder cable124. Thedelivery wire100 may be further advanced through theanchor cable112 andfirst coil114 of theanchor112, wherein thefirst coil114 retracts from the deployed second position to the contracted first position and may be retrieved inside theinner sheath98. Theouter sheath96 containing theoccluder device120 may then be removed from theLAA104, or theoccluder device120 may be re-deployed in a more optimal location of theLAA104. If theoccluder device120 is removed from theLAA104, thedelivery wire100 may be retrieved thereafter, allowing thefirst coil114 of theanchor112 to re-expand from the contracted first position to the deployed second position within theLAA104. Thus, the deployedanchor112 remains inside theLAA104 and allows for occlusion of thesmall hole110 that was created by thepericardial catheter94 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of theLAA wall106.
• Illustrated inFIG. 26, if a determination is made that optimal placement of theanchor112 was not achieved, theanchor112 may be released from theanchor cable122 and deployed alone within theLAA wall106. This allows for anew anchor112 to be placed within theLAA wall106 using the method cited above for achieving optimal placement of theoccluder device120 within theLAA104. On the other hand, if theanchor112 is initially placed in an optimal location within theLAA wall106 but there are problems with theoccluder device120, a second occluder device may be advanced using theinner sheath98 and deployed within theLAA104 using the method cited above. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant theoccluder device120 into theLAA104 usinganchor112, safely retrieve or re-deploy theoccluder device120 if initial placement was improper or if complications arise, with an option to re-implant a new occluder device and new anchor in an optimal location of theLAA104. After optimal placement of theoccluder device120 within theLAA104 is achieved, thedelivery wire100 and thebuddy wire102 may be removed from theLAA104.

Claims (20)

What is claimed is:

1. An anchoring system for implanting an occluder device within a left atrial appendage (LAA) of a heart, comprising:

an outer sheath;

a pericardial catheter;

an occluder device for a LAA;

an anchor;

a contracted first position of the anchor;

a deployed second position of the anchor;

the outer sheath inserted into the LAA through a left atrium proper of the heart;

the pericardial catheter advanced through the outer sheath into the LAA;

the pericardial catheter perforates an inner endocardium layer, middle myocardium layer, and outer epicardium layer of an LAA wall of the heart;

the pericardial catheter creates a small hole through the LAA wall into a pericardial space;

a delivery wire and/or a buddy wire advanced through the pericardial catheter into the pericardial space of the heart through the small hole;

the pericardial catheter removed from the LAA through the outer sheath;

the occluder device and the anchor advanced into the LAA using the delivery wire, wherein the anchor is in the contracted first position;

the anchor in the contracted first position is advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall using the delivery wire;

the anchor in the contracted first position is advanced into the pericardial space through the small hole in the LAA wall using the delivery wire;

the anchor is expanded in the pericardial space from the contracted first position to the deployed second position; and

the occluder device is released from the outer sheath to occlude the LAA;

wherein the anchor moors the occluder device to the LAA wall.

2. The anchoring system ofclaim 1, further comprising:

the occluder device is detached from the anchor;

the anchor is left implanted in the LAA wall of the LAA;

the occluder device is retrieved;

a new anchor is inserted into the LAA;

the new anchor is implanted at another location in the LAA wall, wherein the new anchor is advanced through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall;

the occluder device is released from the outer sheath to occlude the LAA; and

wherein the occluder device is moored to the LAA wall via the new anchor.

3. The anchoring system ofclaim 1, further comprising:

the occluder device is detached from the anchor;

the anchor is left implanted in the LAA wall of the LAA;

the occluder device is retrieved;

a new occluder device is inserted into the LAA via the outer sheath;

the new occluder device is attached to the anchor implanted in the LAA wall of the LAA;

the new occluder device is released from the outer sheath to occlude the LAA; and

wherein the occluder device is moored to the LAA wall via the new anchor.

4. The anchoring system ofclaim 1, wherein the anchor has a diameter of approximately 1-5 mm in the contracted first position and a diameter of approximately 2-20 mm in the deployed second position.

5. The anchoring system ofclaim 1, wherein the anchor is self-expanding.

6. The anchoring system ofclaim 1, wherein the anchor comprises a sheave shape.

7. The anchoring system ofclaim 6, wherein the anchor comprises a first half and a second half, wherein the first half is connected to the second half by a shaft.

8. The anchoring system ofclaim 7, wherein the first half is inside the LAA, the second half is inside the pericardial space, and the shaft is through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall to moor the occluder device within the LAA.

9. The anchoring system ofclaim 8, wherein the anchor comprises a coil.

10. The anchoring system ofclaim 9, wherein the anchor comprises a first coil and a second coil, wherein the first coil is connected to the second coil by a shaft.

11. The anchoring system ofclaim 10, wherein the first coil is inside the LAA, the second coil is inside the pericardial space, and the shaft is through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall to moor the occluder device within the LAA.

12. An anchor for implanting an occluder device within a left atrial appendage (LAA) of a heart, comprising:

an anchor comprising a contracted first position and a deployed second position;

wherein the anchor penetrates an inner endocardium layer, a middle myocardium layer, and an outer epicardium layer of a LAA wall;

wherein a portion of the anchor self-expands from a contracted first position to a deployed second position within a pericardial space of the heart;

wherein the occluder device is moored to the LAA wall via the anchor.

13. The anchor ofclaim 12, further comprising:

wherein the occluder device may be detached from the anchor;

wherein the anchor remains implanted through the LAA wall without harming the patient.

14. The anchor ofclaim 12, further comprising:

wherein the anchor retracts from the deployed second position to the contracted first position;

wherein the anchor re-penetrates at a different location of the LAA wall the inner endocardium layer, the middle myocardium layer, and the outer epicardium layer of the LAA wall;

wherein a portion of the anchor self-expands from a contracted first position to a deployed second position within the pericardial space of the heart; and

wherein the occluder device is moored to the LAA wall via the anchor at a new location.

15. The anchor system ofclaim 12, wherein the anchor has a diameter of approximately 1-5 mm in the contracted first position and a diameter of approximately 2-20 mm in the deployed second position.

16. The anchoring system ofclaim 15, wherein the anchor comprises a sheave shape.

17. The anchoring system ofclaim 15, wherein the anchor comprises a coil.

18. A method of anchoring an occluder device within a left atrial appendage (LAA) of a heart, comprising:

providing an anchoring system for implanting the occluder device within the LAA, wherein the anchoring system comprises:

a) an outer sheath;

b) a pericardial catheter;

c) an occluder device for a LAA;

d) an anchor;

e) a plurality of self-expanding anchor tines or a sheave shape or a coil;

f) a contracted first position of the anchor; and

g) a deployed second position of the anchor;

inserting the outer sheath into the LAA through a left atrium proper of the heart;

advancing the pericardial catheter through the outer sheath into the LAA;

perforating an inner endocardium layer, a middle myocardium layer, and an outer epicardium layer of an LAA wall of the heart using the pericardial catheter;

creating a small hole through the LAA wall into a pericardial space using the pericardial catheter;

advancing a delivery wire and/or a buddy wire through the pericardial catheter into the pericardial space of the heart through the small hole;

removing the pericardial catheter from the LAA through the outer sheath;

advancing the occluder device and anchor into the LAA using the delivery wire, wherein the anchor is in the contracted first position;

advancing the anchor in the contracted first position through the inner endocardium layer, the middle myocardium layer, and the outer epicardium layer of the LAA wall using the delivery wire;

further advancing the anchor in the contracted first position into the pericardial space through the small hole in the LAA wall using the delivery wire;

expanding the anchor from the contracted first position to the deployed second position; and

releasing the occluder device from the outer sheath to occlude the LAA;

wherein the occluder device is moored to the LAA wall via the anchor.

19. The method ofclaim 18, further comprising:

detaching the occluder device from the anchor;

leaving the anchor implanted in the LAA wall of the LAA;

retrieving the occluder device inside the outer sheath;

inserting a new occluder device in the outer sheath;

implanting the new occluder device in the LAA using the anchor;

releasing the occluder device from the outer sheath to occlude the LAA; and

removing the delivery wire, buddy wire, and outer sheath from the LAA.

20. The method ofclaim 18, further comprising:

retrieving the occluder device inside the outer sheath;

removing the anchor from the LAA wall, wherein the anchor retracts from the deployed second position to the contracted first position;

advancing the anchor through the inner endocardium layer, the middle myocardium layer, and the outer epicardium layer at a different location of the LAA wall; and

releasing the occluder device from the outer sheath to occlude the LAA.

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