US20170035433A1

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

Info

Publication number: US20170035433A1
Application number: US14/819,724
Authority: US
Inventors: Thomas J. Forbes
Original assignee: Individual
Current assignee: Individual
Priority date: 2015-08-06
Filing date: 2015-08-06
Publication date: 2017-02-09
Also published as: US11109868B2; WO2017023606A1; US10143478B2; US20190069901A1; US20170035434A1

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 of FIG. 1.

FIG. 3 is a view of an anchor of the anchoring system and method of claim 1, wherein the anchor comprises anchor tines.

FIG. 3A is an end-view of the anchor of FIG. 3, wherein anchor tines are in a contracted first position.

FIG. 3B is an end-view of the anchor of FIG. 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 of FIG. 1, wherein the anchor comprises a coil-wire.

FIG. 4A is an end-view of the anchor of FIG. 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 of FIG. 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 of FIG. 1, wherein the anchor and the occluder device are advanced into the LAA.

FIG. 6 is a view of the anchoring system and method of FIG. 5, wherein the anchor is advanced through the LAA wall.

FIG. 7 is a view of the anchoring system and method of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 10, wherein the inner dilator and anchor catheter penetrate the LAA wall.

FIG. 12 is a view the anchoring system and method of FIG. 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 of FIG. 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 of FIG. 13, wherein the anchor is in a contracted first position.

FIG. 13B is a side-view of the anchor of FIG. 13, wherein the anchor is in a deployed second position.

FIG. 14 is a view of the anchoring system and method of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 20, wherein the anchor is in a contracted first position.

FIG. 21B is a side-view of the anchor of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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 of FIG. 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, an anchoring system 10 for implanting and retrieving an occluder device within a LAA. The anchoring system 10 may comprise a pericardial catheter 14, wherein the pericardial catheter 14 may be a single or double-lumen pericardial catheter. The anchoring system 10 may further comprise an outer sheath 16 and an inner sheath 18. 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-lumen pericardial catheter 14 may be configured to fit a delivery wire 20 and/or a buddy wire 22, also standardly used in the industry. A diameter of the delivery wire 20 may range between approximately 0.025-0.052 inches and a diameter of the buddy wire 22 may range between approximately 0.008 0.025 inches.
Further illustrated in FIG. 1, the outer sheath 16 may be inserted into LAA 24 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 the LAA 24 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath 16 within the LAA 24 and allow for better imaging of the LAA 24 by an interventional cardiologist. The pericardial catheter 14 may be advanced through the outer sheath 16, wherein the pericardial catheter 14 penetrates LAA wall 26 and enters pericardial space 28. Specifically, the pericardial catheter 14 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26. Thus, the pericardial catheter 14 creates a small hole 30 through the LAA wall 26 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of bleeding and fluid accumulating within the pericardial space 28 via the small hole 30. While the pericardial catheter 14 remains inside the pericardial space 28 via the small hole 30, the delivery wire 20 and/or the buddy wire 22 may be advanced through the pericardial catheter 14, wherein the delivery wire 20 and/or the buddy wire 22 enter the pericardial space 28. The buddy wire 22 remains inside the pericardial space 28 and is a safety feature in case of emergencies. The buddy wire 22 allows a interventional cardiologist to advance another catheter through the LAA wall 26 and place a plug within the small hole 30 if a malfunction is observed with the anchor 32 or the occluder device 36. The pericardial catheter 14 may then be removed from the outer sheath 16, leaving the delivery wire 20 and/or the buddy wire 22 inside the pericardial space 28 via the small hole 30 in the LAA wall 26.
Illustrated in FIG. 2, the anchoring system 10 of the present invention further comprises an anchor 32, an occluder device 36, and a connector 38. It is contemplated that the anchoring system 10 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 in FIG. 2, the occluder device 36 is connected to the anchor 32 via the connector 38. The connector 38 may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or other materials standardly used in the industry. The connector 38 may be square, flat, rectangular, round, spherical, coiled, ovular, a combination thereof, or any other shape. The connector 38 may be approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It is intended that the connector 38 provide flexibility between the anchor 32 and the occluder device 36. This flexibility may be achieved via an articulating joint, such as a ball-and-socket joint 44, shown in FIG. 2. The ball-and-socket joint 44 of FIG. 2 is illustrated for example purposes only. It is not intended that the connector 38 of the present invention be limited to a ball-and-socket joint 44. 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 the connector 38 provide flexibility between the occluder device 36 and the anchor 32 to allow for multiple insertion sites within the LAA 24, thus, ensuring the occluder device 36 is properly positioned within the LAA 24 once deployed. Furthermore, the connector 38 may allow an interventional cardiologist via a cable (not shown) to conveniently attach the occluder device 36 to the anchor 32, release the occluder device 36 from the anchor 32, and reattach the occluder device 36 to the anchor 32 without damaging the occluder device 36.
Illustrated in FIG. 3, the anchor 32 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The length of the anchor 32 may be approximately 1-10 mm, wherein the width of the anchor 32 may be approximately 1-20 mm. The anchor 32 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 32 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 in FIG. 3, the anchor 32 may comprise a plurality of self-expanding anchor tines 39, wherein the plurality may comprise 2-10 tines. The anchor tines 39 may be approximately 5-20 mm in length and approximately 0.01-1.5 mm in width. The anchor tines 39 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 tines 39 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The anchor tines 39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the anchor tines 39 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, the anchor 32 of the present invention may comprise a self-expanding coil-wire 40 instead of the anchor tines 39 as illustrated in FIG. 4. The coil-wire 40 may be approximately 5-25 mm in length and 0.01-1.5 mm in width. The coil-wire 40 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-wire 40 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The coil-wire 40 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the coil-wire 40 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.
The anchor 32 may have a contracted first position (FIGS. 3A, 4A) and a deployed second position (FIGS. 3B, 4B). When the anchor tines 39 are utilized, the anchor tines 39 may expand outwards a distance of approximately 2-20 mm in diameter in the deployed second position (FIG. 3B). Alternatively when the coil-wire 40 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-wire 40 may have any shape compatible with the LAA 24.
Illustrated in FIG. 5, the inner sheath 18 is advanced up to and adjacent the LAA wall 26. The anchor 32, the connector 38, and the occluder device 36 are next advanced through the inner sheath 18 using the delivery wire 20, wherein the anchor 32 resides adjacent the small hole 30 in the LAA wall 26.
Illustrated in FIG. 6, the anchor 32, the connector 38, and the occluder device 36 are further advanced through the inner sheath 18 using the delivery wire 20, wherein the anchor 32 penetrates the LAA wall 26 via the small hole 30 and extends into the pericardial space 28. Specifically, the anchor 32 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26. Once inside the pericardial space 28, the anchor 32 self-expands from the contracted first position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B, 4B).
Illustrated in FIG. 7, the inner sheath 18 is retracted inside the outer sheath 16 after the anchor 32 has been implanted in the LAA wall 26. This effectively releases the occluder device 36 into the LAA 24. The expanded anchor 32 in the deployed second position (FIGS. 3B, 4B) covers a large surface area and therefore retains the occluder device 36 in an implanted position within the LAA 24. Moreover, by anchoring the occluder device 36 via the anchor 32 through all three layers of the LAA wall 26—instead of merely latching onto the thin endocardium layer—the anchoring system 10 of the present invention lowers the risk of embolization.
FIGS. 8-9 illustrate the anchoring system 10 of the present invention if problems arise after deployment of the occluder device 36. For instance, it may be determined that the occluder device 36 is not placed in an optimal location of the LAA 24 after deployment to achieve maximum occlusion. The anchoring system 10 of the present invention offers two solutions to overcome these problems.
The first solution is illustrated in FIG. 8, wherein an interventional cardiologist may use a cable (not shown) to detach 42 the occluder device 36 from the anchor 32 via connector 38. The occluder device 36 is then retrieved inside the inner sheath 18 via the cable. The anchor 32 is expendable and may be left implanted in the LAA wall 26 where it causes no harm to the patient. A new anchor 32 is then connected to the occluder device 36 via the connector 38, and the anchoring steps repeated until optimal placement of the occluder device 36 within the LAA 24 is achieved.
The second solution is illustrated in FIG. 9, wherein the occluder device 36 is retrieved inside the inner sheath 18 via a cable (not shown). The inner sheath 18 is then advanced to envelope the anchor 32 and press up against the LAA wall 26. While the inner sheath 18 is pressed up against the LAA wall 26, the anchor 32 is pulled back through the LAA wall 26, into the LAA 24, and retrieved 46 inside the inner sheath 18 via the cable. The anchor 32 is designed to retract from the deployed second position (FIGS. 3B, 4B) into the contracted first position (FIGS. 3A, 4A) without tearing or ripping the LAA wall 26 as the anchor 32 is retrieved inside the inner sheath 18. Thus, the anchoring system 10 of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device 36 into the LAA 24 using anchor 32, safely retrieve the occluder device 36 and anchor 32 if initial placement was improper or if complications arise, and then reuse and re-implant the occluder device 36 and anchor 32 in an optimal location of the LAA 24. Ultimately after optimal placement of the occluder device within the LAA is achieved, the delivery wire 20 and buddy wire 22 are removed from the LAA via the outer 16 sheath. The outer sheath 16 may be subsequently removed from the LAA 24 via the left atrium proper of the heart.
In another aspect of the present invention, an anchor 32 is provided for anchoring an occluder device 36 within the LAA 24. As illustrated in FIG. 3, the anchor 32 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The length of the anchor 32 may be approximately 1-10 mm, wherein the width of the anchor 32 may be approximately 1-20 mm. The anchor 32 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 32 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 in FIG. 2, the anchor 32 is further configured to connect to an occluder device 36 via a connector 38. The connector 38 may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or other materials standardly used in the industry. The connector 38 may be square, flat, rectangular, round, spherical, coiled, ovular, a combination thereof, or any other shape. The connector 38 may be approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It is intended that the connector 38 provide flexibility between the anchor 32 and the occluder device 36. This flexibility may be achieved via an articulating joint, such as a ball-and-socket joint 44, shown in FIG. 2. The ball-and-socket joint 44 of FIG. 2 is illustrated for example purposes only. It is not intended that the connector 38 of the present invention be limited to a ball-and-socket joint 44. 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 the connector 38 provide flexibility between the occluder device 36 and the anchor 32 to allow for multiple insertion sites within the LAA 24, thus, ensuring the occluder device 36 is properly positioned within the LAA 24 once deployed. Furthermore, the connector 38 may allow an interventional cardiologist via a cable (not shown) to conveniently attach the occluder device 36 to the anchor 32, release the occluder device 36 from the anchor 32, and reattach the occluder device 36 to the anchor 32 without damaging the occluder device 36.
Further illustrated in FIG. 3, the anchor 32 may comprise a plurality of self-expanding anchor tines 39, wherein the plurality may comprise 2-10 tines. The anchor tines 39 may be approximately 5-20 mm in length and approximately 0.01-1.5 mm in width. The anchor tines 39 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 tines 39 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The anchor tines 39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the anchor tines 39 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, the anchor 32 of the present invention may comprise a self-expanding coil-wire 40 instead of the anchor tines 39 as illustrated in FIG. 4. The coil-wire 40 may be approximately 5-25 mm in length and 0.01-1.5 mm in width. The coil-wire 40 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-wire 40 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The coil-wire 40 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the coil-wire 40 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.
The anchor 32 may have a contracted first position (FIGS. 3A, 4A) and a deployed second position (FIGS. 3B, 4B). When the anchor tines 39 are utilized, the anchor tines 39 may expand outwards a distance of approximately 2-20 mm in diameter in the deployed second position (FIG. 3B). Alternatively when the coil-wire 40 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-wire 40 may have any shape compatible with the LAA 24.
Illustrated in FIG. 6, the anchor 32 is configured to penetrate the LAA wall 26 via a pre-made small hole 30 through the LAA wall. Specifically, the anchor 32 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26. The anchor 32 extends into the pericardial space 28, wherein the anchor 32 self-expands from the contracted first position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B, 4B). The expanded anchor 32 in the deployed second position (FIGS. 3B, 4B) covers a large surface area and therefore retains the occluder device 36 in an implanted position within the LAA 24. Moreover, by anchoring the occluder device 36 via the anchor 32 through all three layers of the LAA wall 26—instead of merely latching onto the thin endocardium layer—the anchor 32 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 in FIG. 1. The method of the present invention comprises providing an anchoring system 10. The anchoring system 10 comprises a pericardial catheter 14, wherein the pericardial catheter 14 may be a single or double-lumen pericardial catheter. The anchoring system 10 may further comprise an outer sheath 16 and an inner sheath 18. 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. The pericardial catheter 14 may be configured to fit a delivery wire 20 and/or a buddy wire 22, also standardly used in the industry. A diameter of the delivery wire 20 may range between approximately 0.025-0.052 inches and a diameter of the buddy wire 22 may range between approximately 0.008-0.025 inches.
Further illustrated in FIG. 1, the method of the present invention comprises inserting the outer sheath 16 into LAA 24 via the left atrium proper of the heart. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude the LAA 24 from the left atrium proper. Next, the pericardial catheter 14 may be advanced through the outer sheath 16, wherein the pericardial catheter 14 penetrates LAA wall 26 and enters pericardial space 28. Specifically, the pericardial catheter 14 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26. Thus, the pericardial catheter 14 creates a small hole 30 through the LAA wall 26 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within the pericardial space 28 via the small hole 30. While the pericardial catheter 14 remains inside the pericardial space 28 via the small hole 30, the delivery wire 20 and the buddy wire 22 may be advanced through the pericardial catheter 14, wherein the delivery wire 20 and the buddy wire 22 enter the pericardial space 28. The buddy wire 22 remains inside the pericardial space 28 and is a safety feature in case of emergencies. The buddy wire 22 allows an interventional cardiologist to advance another catheter through the LAA wall 26 and place a plug within the small hole 30 if a malfunction is observed with the anchor 32 or the occluder device 36. The pericardial catheter 14 may then be removed from the outer sheath 16, leaving the delivery wire 20 and the buddy wire 22 inside the pericardial space 28 via the small hole 30 in the LAA wall 26.
Illustrated in FIG. 2, the method of the present invention further comprises providing an anchor 32, an occluder device 36, and a connector 38. 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 in FIG. 2, the method of the present invention comprises connecting the occluder device 36 to the anchor 32 via the connector 38. The connector 38 may be comprised of stainless steel, platinum, Nitinol, Elgiloy, or other materials standardly used in the industry. The connector 38 may be square, flat, rectangular, round, spherical, coiled, ovular, a combination thereof, or any other shape. The connector 38 may be approximately 0.5 mm-10 mm in length and approximately 0.5 mm-10 mm in width. It is intended that the connector 38 provide flexibility between the anchor 32 and the occluder device 36. This flexibility may be achieved via an articulating joint, such as a ball-and-socket joint 44, shown in FIG. 2. The ball-and-socket joint 44 of FIG. 2 is illustrated for example purposes only. It is not intended that the connector 38 of the present invention be limited to a ball-and-socket joint 44. 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 the connector 38 provide flexibility between the occluder device 36 and the anchor 32 to allow for multiple insertion sites within the LAA 24, thus, ensuring the occluder device 36 is properly positioned within the LAA 24 once deployed. Furthermore, the connector 38 may allow an interventional cardiologist via a cable (not shown) to conveniently attach the occluder device 36 to the anchor 32, release the occluder device 36 from the anchor 32, and reattach the occluder device 36 to the anchor 32 without damaging the occluder device 36.
Illustrated in FIG. 3, the anchor 32 may be comprised of a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The length of the anchor 32 may be approximately 1-10 mm, wherein the width of the anchor 32 may be approximately 1-20 mm. The anchor 32 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 32 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 in FIG. 3, the anchor 32 may comprise a plurality of self-expanding anchor tines 39, wherein the plurality may comprise 2-10 tines. The anchor tines 39 may be approximately 5-20 mm in length and approximately 0.01-1.5 mm in width. The anchor tines 39 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 tines 39 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The anchor tines 39 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the anchor tines 39 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, the anchor 32 of the present invention may comprise a self-expanding coil-wire 40 instead of the anchor tines 39 as illustrated in FIG. 4. The coil-wire 40 may be approximately 5-25 mm in length and 0.01-1.5 mm in width. The coil-wire 40 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-wire 40 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment. The coil-wire 40 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. It is also contemplated that the coil-wire 40 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.
The anchor 32 may have a contracted first position (FIGS. 3A, 4A) and a deployed second position (FIGS. 3B, 4B). When the anchor tines 39 are utilized, the anchor tines 39 may expand outwards a distance of approximately 2-20 mm in diameter in the deployed second position (FIG. 3B). Alternatively when the coil-wire 40 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-wire 40 may have any shape compatible with the LAA 24.
Illustrated in FIG. 5, the method of the present invention further comprises advancing the inner sheath 18 up to and adjacent the LAA wall 26. The anchor 32, the connector 38, and the occluder device 36 are next advanced through the inner sheath 18 using the delivery wire 20, wherein the anchor 32 resides adjacent the small hole 30 in the LAA wall 26.
Illustrated in FIG. 6, the method of the present invention comprises further advancing the anchor 32, the anchor tines 39, the connector 38, and the occluder device 36 through the inner sheath 18 using the delivery wire 20, wherein the anchor 32 penetrates the LAA wall 26 via the small hole 30 and extends into the pericardial space 28. Specifically, the anchor 32 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26. Once inside the pericardial space 28, the anchor 32 self-expands from the contracted first position (FIGS. 3A, 4A) to the deployed second position (FIGS. 3B, 4B).
Illustrated in FIG. 7, the method of the present invention further comprises retracting the inner sheath 18 inside the outer sheath 16 after the anchor 32 has been implanted in the LAA wall 26. This effectively releases the occluder device 36 into the LAA 24. The expanded anchor 32 in the deployed second position (FIGS. 3B, 4B) covers a large surface area and therefore retains the occluder device 36 in an implanted position within the LAA 24. Moreover, by anchoring the occluder device 36 via the anchor 32 through all three layers of the LAA wall 26—instead of merely latching onto the thin endocardium layer—the anchoring system 10 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 the occluder device 36. For example, it may be determined that the occluder device 36 is not placed in an optimal location of the LAA 24 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 in FIG. 8, wherein an interventional cardiologist may use a cable (not shown) to detach 42 the occluder device 36 from the anchor 32 via connector 38. The occluder device 36 is then retrieved inside the inner sheath 18 via the cable. The anchor 32 is expendable and may be left implanted in the LAA wall 26 where it causes no harm to the patient. A new anchor 32 is then connected to the occluder device 36 via the connector 38, and the anchoring steps repeated until optimal placement of the occluder device 36 within the LAA 24 is achieved.
The second solution is illustrated in FIG. 9, wherein the occluder device 36 is retrieved inside the inner sheath 18 via a cable (not shown). The inner sheath 18 is then advanced to envelope the anchor 32 and press up against the LAA wall 26. While the inner sheath 18 is pressed up against the LAA wall 26, the anchor 32 is pulled back through the LAA wall 26, into the LAA 24, and retrieved 46 inside the inner sheath 18 via the cable. The anchor 32 is designed to retract from the deployed second position (FIGS. 3B, 4B) into the contracted first position (FIGS. 3A, 4A) without tearing or ripping the LAA wall 26 as the anchor 32 is retrieved inside the inner sheath 18. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device 36 into the LAA 24 using anchor 32, safely retrieve the occluder device 36 and anchor 32 if initial placement was improper or if complications arise, and then reuse and re-implant the same occluder device 36 and anchor 32 in an optimal location of the LAA 24. Ultimately after optimal placement of the occluder device within the LAA is achieved, the delivery wire 20 and buddy wire 22 are removed from the LAA via the outer sheath 16. The outer sheath 16 may be subsequently removed from the LAA 24 via the left atrium proper of the heart.
FIG. 10 illustrates a further aspect of the present invention, an anchoring system 50 for implanting and retrieving an occluder device within a LAA. The anchoring system 50 may comprise a pericardial catheter 54, wherein the pericardial catheter 54 may be a single or double-lumen pericardial catheter. The anchoring system 50 may further comprise an outer sheath 56. 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 pericardial catheter 54 may be configured to fit a delivery wire 60 and/or a buddy wire 62, also standardly used in the industry. A diameter of the delivery wire 60 may range between approximately 0.025-0.052 inches and a diameter of the buddy wire 62 may range between approximately 0.008-0.025 inches.
Further illustrated in FIG. 10, the outer sheath 56 may be inserted into LAA 64 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 the LAA 64 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath 56 within the LAA 64 and allow for better imaging of the LAA 64 by an interventional cardiologist. The pericardial catheter 54 may be advanced through the outer sheath 56 to the LAA wall 66. The buddy wire 62 is next advanced through the pericardial catheter 54 and the adjacent LAA wall 66, wherein the buddy wire 62 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26 to extend into the pericardial space 68. The pericardial catheter 54 is next advanced over the buddy wire 62 and through the LAA wall 66, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66 to extend into the pericardial space 68. Thus, the pericardial catheter 54 creates a small hole 70 through the LAA wall 66 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within the pericardial space 68 via the small hole 70. While the pericardial catheter 54 remains inside the pericardial space 68 via the small hole 70, the delivery wire 60 may then be advanced through the pericardial catheter 54, wherein the delivery wire 60 enters the pericardial space 68. The pericardial catheter 54 may then be removed from the outer sheath 56, leaving the delivery wire 60 and the buddy wire 62 inside the pericardial space 68 via the small hole 70 in the LAA wall 66.
Illustrated in FIG. 11, the anchoring system 50 of the present invention further comprises an anchor catheter 58 and an inner dilator 86, wherein the inner dilator 86 includes a pointed distal end 88. The inner dilator 86 may be configured to encompass the delivery wire 60, wherein the delivery wire 60 may traverse through an inner lumen of the inner dilator 86. The anchor catheter 58 and the inner dilator 86 may be advanced through the outer sheath 56 to the LAA wall 66 adjacent the small hole 70. Particularly, the delivery wire 60 may traverse through the anchor catheter 52 and the inner dilator 86. The buddy wire 62 may reside outside the anchor catheter 58 and yet inside the outer sheath 56. Using the pointed distal end 88 of the inner dilator 86, the inner dilator 86 and the anchor catheter 52 may be further advanced through the small hole 70 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66. Thus, the pointed distal end 88 of the inner dilator 86, along with a distal end of the anchor catheter 52, extends into the pericardial space 68. The inner dilator 86 may be subsequently removed from the anchor catheter 58, wherein the distal end of the anchor catheter 58 remains extending into the pericardial space 68.
Illustrated in FIG. 12, the anchoring system 50 of the present invention further comprises an occluder device 80 and an occluder cable 84. It is contemplated that the anchoring system 50 of the present invention may be used with a diverse range of LAA occluder devices 80 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 80 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, the occluder device 80 may have a distal end with a hole approximately 1-5 mm in diameter. As shown in FIG. 12, the occluder cable 84 may be a hollow coaxial cable standardly used in the industry. The occluder cable 84 may be attached to the occluder device 80, wherein the occluder cable 84 may be used for deploying and retrieving the occluder device 80 within the LAA 64. The occluder device 80 and the occluder cable 84 may encompass the anchor catheter 58, wherein the anchor catheter 58 may traverse through an inner lumen of the occluder device 80 and an inner lumen of the occluder cable 84. The occluder device 80 may reside between the anchor catheter 58 and the outer sheath 56.
As further shown in FIG. 12, the anchoring catheter 58 may comprise an anchor 72 and an anchor cable 82. The anchor cable 82 may be attached to the anchor 72, wherein the anchor cable 82 may be used for deploying the anchor 72 within the LAA wall 66. The anchor cable 82 may be a hollow coaxial cable standardly used in the industry. The anchor cable 82 and anchor 72 may encompass the delivery wire 60, wherein the delivery wire 60 may traverse through an inner lumen of the anchor 72 and an inner lumen of the anchor cable 82. The delivery wire 60 may be used to navigate the anchoring system 50 through the LAA 64. Alternatively, the anchor 72 and anchor cable 82 may be advanced through the anchor catheter 58 into the pericardial space 68 without using the delivery wire 60. The buddy wire 62 may remain inside the pericardial space 68 and is a safety feature in case of emergencies. The buddy wire 62 allows an interventional cardiologist to advance another catheter through the LAA wall 66 and place a plug within the small hole 70 if a malfunction is observed with the anchor 72 or the occluder device 80.
Illustrated in FIG. 13, the anchor 72 may be shaped like a sheave, comprising a first half 74, a second half 76, and a shaft 78 connecting the first half 74 to the second half 76, although it is contemplated that other anchor shapes may also be utilized in the present invention. The anchor 72 may be comprised of wire, wherein the first half 74 and second half 76 of the anchor 72 comprise wire mesh, further wherein the shaft 78 may comprise a single wire connecting the first half 75 wire mesh and the second half 76 wire mesh. The anchor 72 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. The anchor 72 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. The anchor 72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 72 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. The anchor 72 may have a lumen wherein the delivery wire 60 traverses therein, alternatively, the anchor 72 may not have a lumen. The anchor 72 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
Illustrated in FIGS. 13A-B, the anchor 72 may have a contracted first position (FIG. 13A) and a deployed second position (FIG. 13B). In the contracted first position (FIG. 13A), the first half 74, second half 76, and shaft 78 of the anchor 72 have a diameter of approximately 1-5 mm and a length of approximately 5-55 mm. In the deployed second position (FIG. 13B), the first half 74 and second half 76 of the anchor 72 may expand outwards a distance of approximately 5-25 mm in diameter, wherein the shaft 78 remains approximately 1-5 mm in diameter. The anchor 72 may self-expand from the contracted first position (FIG. 13A) to the deployed second position (FIG. 13B).
Illustrated in FIG. 14, the anchor 72 in the contracted first position (FIG. 13A) may be advanced through the anchor catheter 58 using the anchor cable 82 and the delivery wire 60, wherein the anchor 72 extends into the pericardial space 68. The anchor catheter 58 may then be retracted, allowing the second half 76 of the anchor 72 to self-expand from the contracted first position to the deployed second position within the pericardial space 68. While the second half 76 of the anchor 72 is in the deployed second position, the shaft 78 and the first half 74 of the anchor 72 remain temporarily inside the anchor catheter 58.
Illustrated in FIG. 15, the anchor catheter 58 may be further retracted, allowing the first half 74 of the anchor 72 to self-expand from the contracted first position to a partially deployed second position within the occluder device 80, wherein the occluder device 80 remains inside the outer sheath 56. The shaft 78 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66. The second half 76 of the anchor 72 remains in the deployed second position within the pericardial space 68, wherein the first half 74 of the anchor 72 is in the partially deployed second position within the occluder device 80. Alternatively, the anchor 72 and occluder device 80 may be integral, wherein the occluder device 80 may be a coil occluder device. Thus, the integral anchor 72 and occluder device 80 may be advanced together through the anchor catheter 58, wherein the anchor 72 is implanted in the LAA wall 66 using the system 50 of the present invention described above.
Illustrated in FIG. 16, the outer sheath 56 may be retracted to allow the occluder device 80 to expand inside the LAA 64. Moreover, retracting the outer sheath 56 allows the first half 74 of the anchor 72 to fully expand into the deployed second position within the occluder device 80. Thus, the shaft 78 of the anchor 72 may extend through the hole in the distal end of the occluder device 80, wherein the distal end of the occluder device 80 pinches down on the shaft 78. Furthermore, the first half of the anchor 74 in the deployed second position may pin the occluder device 80 against the LAA wall 66, wherein the anchor 72 effectively moors the occluder device 80 inside the LAA 64. At this time the expanded anchor 72 in the deployed second position covers a large surface area and therefore retains the occluder device 80 in an implanted position within the LAA 64. Moreover, by anchoring the occluder device 80 via the anchor 72 through all three layers of the LAA wall 66—instead of merely latching onto the thin endocardium layer—the anchoring system 50 of the present invention lowers the risk of embolization. Here, the anchor cable 82 remains attached to the anchor 72 and the occluder cable 84 remains attached to the occluder device 80 in case problems arise after deployment of the occluder device 80. If no problems arise and it is determined that the occluder device 80 is in an optimal location of the LAA 64, the occluder cable 84 may be detached from the occluder device 80 and removed from the LAA 64. Furthermore, the anchor cable 82 may be detached from the anchor 72 and removed from the LAA 64. The buddy wire 62 and delivery wire 60 may also be withdrawn from the LAA 64, leaving the occluder device 80 anchored securely in the LAA 64 by the anchoring system 50 of the present invention.
FIG. 17 illustrates the anchoring system 50 of the present invention if problems arise after deployment of the occluder device 80. For instance, it may be determined that the occluder device 80 is not placed in an optimal location of the LAA 64 after deployment to achieve maximum occlusion. In this situation—prior to release of the occluder cable 84 from the occluder device 80 and the anchor cable 82 from the anchor 72—the outer sheath 56 may be advanced over the occluder device 80 to the LAA wall 66, wherein the occluder device 80 is retracted inside the outer sheath 56 using the occluder cable 82. The anchor catheter 58 may then be advanced to the LAA wall 66, wherein the first half 74 of the anchor 72 is retracted inside the anchor catheter 58 using the anchor cable 82. Thus, using the anchor cable 82, the first half 74 of the anchor 72 retracts from the deployed second position to the contracted first position to fit inside the anchor catheter 58. The outer sheath 56 containing the occluder device 80 may then be removed from the LAA 64, or the occluder device 80 may be re-deployed in a more optimal location of the LAA 64. If the occluder device 80 is removed from the LAA 64, the anchor catheter 58 may be retrieved thereafter, allowing the first half 74 of the anchor 72 to expand from the contracted first position to the deployed second position within the LAA 64. Thus, the deployed anchor 72 remains inside the LAA 64 and allows for occlusion of the small hole 70 that was created by the pericardial catheter 54 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66.
Illustrated in FIG. 18, if optimal placement of the occluder device 80 was not achieved the anchor 72 may be released from the anchor cable 82 and deployed alone within the LAA wall 66 to plug the small hole 70 and prevent fluids from entering the pericardial space 68. The delivery wire 60 and buddy wire 62 may be subsequently removed from the LAA 64. This allows for a new anchor 72 to be placed within the LAA wall 66 using the anchoring system 50 cited above for achieving optimal placement of the occluder device 80 within the LAA 64. On the other hand, if the anchor 72 is initially placed in an optimal location within the LAA wall 66 but there are problems with the occluder device 80, a second occluder device may be advanced over the inner sheath 58 and deployed within the LAA 64 using the anchoring system 50 cited above. Thus, the anchoring system 50 of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device 80 into the LAA 64 using anchor 72, safely retrieve or re-deploy the occluder device 80 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 the LAA 24. After optimal placement of the occluder device 80 within the LAA 64 is achieved, the delivery wire 60 and buddy wire 62 may be removed from the LAA 64.
In another aspect of the present invention, an anchor 72 is provided for anchoring an occluder device 80 within a LAA 64. As illustrated in FIG. 13, the anchor 72 may be shaped like a sheave, comprising a first half 74, a second half 76, and a shaft 78 connecting the first half 74 to the second half 76, although it is contemplated that other anchor shapes may also be utilized in the present invention. The anchor 72 may be comprised of wire, wherein the first half 74 and second half 76 of the anchor 72 comprise wire mesh, further wherein the shaft 78 may comprise a single wire connecting the first half 75 wire mesh and the second half 76 wire mesh. The anchor 72 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. The anchor 72 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. The anchor 72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 72 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. The anchor 72 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
Illustrated in FIGS. 13A-B, the anchor 72 may have a contracted first position (FIG. 13A) and a deployed second position (FIG. 13B). In the contracted first position (FIG. 13A), the first half 74, second half 76, and shaft 78 of the anchor 72 have a diameter of approximately 1-5 mm and a length of approximately 5-55 mm. In the deployed second position (FIG. 13B), the first half 74 and second half 76 of the anchor 72 may expand outwards a distance of approximately 5-25 mm in diameter, wherein the shaft 78 remains approximately 1-5 mm in diameter. The anchor 72 may self-expand from the contracted first position (FIG. 13A) to the deployed second position (FIG. 13B).
It is contemplated that the anchor 72 of the present invention may be used with a diverse range of LAA occluder devices 80 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 80 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, the occluder device 80 may have a distal end with a hole approximately 1-5 mm in diameter.
Illustrated in FIG. 14, the anchor 72 in the contracted first position (FIG. 13A) may be advanced through an anchor catheter 58 using an anchor cable 82 and a delivery wire 60, wherein the anchor 72 extends into pericardial space 68. The anchor catheter 58 may then be retracted, allowing the second half 76 of the anchor 72 to self-expand from the contracted first position to the deployed second position within the pericardial space 68. While the second half 76 of the anchor 72 is in the deployed second position, the shaft 72 and the first half 74 of the anchor 72 remain temporarily inside the anchor catheter 58.
Illustrated in FIG. 15, the anchor catheter 58 may be further retracted, allowing the first half 74 of the anchor 72 to self-expand from the contracted first position to a partially deployed second position within the occluder device 80, wherein the occluder device 80 remains inside the outer sheath 56. The shaft 78 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26. The second half 76 of the anchor 72 remains in the deployed second position within the pericardial space 68, wherein the first half 74 of the anchor 72 is in the partially deployed second position within the occluder device 80. Alternatively, the anchor 72 and occluder device 80 may be integral, wherein the occluder device 80 may be a coil occluder device. Thus, the integral anchor 72 and occluder device 80 may be advanced together through the anchor catheter 58, wherein the anchor 72 is implanted in the LAA wall 26 using the system 50 of the present invention described above.
Illustrated in FIG. 16, the outer sheath 56 may be retracted to allow the occluder device 80 to expand inside the LAA 64. Moreover, retracting the outer sheath 56 allows the first half 74 of the anchor 72 to fully expand into the deployed second position within the occluder device 80. Thus, the shaft 78 of the anchor 72 may extend through the hole in the distal end of the occluder device 80, wherein the distal end of the occluder device 80 pinches down on the shaft 78. Furthermore, the first half of the anchor 74 in the deployed second position may pin the occluder device 80 against the LAA wall 66, wherein the anchor 72 effectively moors the occluder device 80 inside the LAA 64. At this time the expanded anchor 72 in the deployed second position covers a large surface area and therefore retains the occluder device 80 in an implanted position within the LAA 64. Moreover, by anchoring the occluder device 80 via the anchor 72 through all three layers of the LAA wall 66—instead of merely latching onto the thin endocardium layer—the anchoring system 50 of the present invention lowers the risk of embolization. Here, the anchor cable 82 remains attached to the anchor 72 and an occluder cable 84 remains attached to the occluder device 80 in case problems arise after deployment of the occluder device 80. If no problems arise and it is determined that the occluder device 80 is in an optimal location of the LAA 64, the occluder cable 84 may be detached from the occluder device 80 and removed from the LAA 64. Furthermore, the anchor cable 82 may be detached from the anchor 72 and removed from the LAA 64. The delivery wire 60 and/or a buddy wire 62 may also be withdrawn from the LAA 64, leaving the occluder device 80 anchored securely in the LAA 64 by the anchor 72 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 in FIG. 10. The method of the present invention comprises providing an anchoring system 50. The anchoring system 50 may comprise a pericardial catheter 54, wherein the pericardial catheter 54 may be a single or double-lumen pericardial catheter. The anchoring system 50 may further comprise an outer sheath 56. 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 pericardial catheter 54 may be configured to fit a delivery wire 60 and/or a buddy wire 62, also standardly used in the industry. A diameter of the delivery wire 60 may range between approximately 0.025-0.052 inches and a diameter of the buddy wire 62 may range between approximately 0.008-0.025 inches.
Further illustrated in FIG. 10, the method of the present invention further comprises inserting the outer sheath 56 into the LAA 64 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 the LAA 64 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath 56 within the LAA 64 and allow for better imaging of the LAA 64 by an interventional cardiologist. The pericardial catheter 54 may be advanced through the outer sheath 56 to the LAA wall 66. The buddy wire 62 is next advanced through the pericardial catheter 54 and the adjacent LAA wall 66, wherein the buddy wire 62 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 26 to extend into the pericardial space 68. The pericardial catheter 54 is advanced over the buddy wire 62 and through the LAA wall 66, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66 to extend into the pericardial space 68. Thus, the pericardial catheter 54 creates a small hole 70 through the LAA wall 66 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within the pericardial space 68 via the small hole 70. While the pericardial catheter 54 remains inside the pericardial space 68 via the small hole 70, the delivery wire 60 may then be advanced through the pericardial catheter 54, wherein the delivery wire 60 enters the pericardial space 68. The pericardial catheter 54 may then be removed from the outer sheath 56, leaving the delivery wire 60 and the buddy wire 62 inside the pericardial space 68 via the small hole 70 in the LAA wall 66.
Illustrated in FIG. 11, the method of the present invention further comprises providing an anchor catheter 58 and an inner dilator 86, wherein the inner dilator 86 includes a pointed distal end 88. The inner dilator 86 may be configured to encompass the delivery wire 60, wherein the delivery wire 60 may traverse through an inner lumen of the inner dilator 86. The anchor catheter 58 and the inner dilator 86 may be advanced through the outer sheath 56 to the LAA wall 66 adjacent the small hole 70. Particularly, the delivery wire 60 may traverse through the anchor catheter 52 and the inner dilator 86. The buddy wire 62 may reside outside the anchor catheter 58 and yet inside the outer sheath 56. Using the pointed distal end 88 of the inner dilator 86, the inner dilator 86 and the anchor catheter 52 may be further advanced through the small hole 70 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66. Thus, the pointed distal end 88 of the inner dilator 86, along with a distal end of the anchor catheter 52, extends into the pericardial space 68. The inner dilator 86 may be subsequently removed from the anchor catheter 58, wherein the distal end of the anchor catheter 58 remains extending into the pericardial space 68.
Illustrated in FIG. 12, the method of the present invention further comprises providing an occluder device 80 and an occluder cable 84. It is contemplated that the method of the present invention may be used with a diverse range of LAA occluder devices 80 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 80 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, the occluder device 80 may have a distal end with a hole approximately 1-5 mm in diameter. As shown in FIG. 12, the occluder cable 84 may be a hollow coaxial cable standardly used in the industry. The occluder cable 84 may be attached to the occluder device 80, wherein the occluder cable 84 may be used for deploying and retrieving the occluder device 80 within the LAA 64. The occluder device 80 and the occluder cable 84 may encompass the anchor catheter 58, wherein the anchor catheter 58 may traverse through an inner lumen of the occluder device 80 and an inner lumen of the occluder cable 84. The occluder device 80 may reside between the anchor catheter 58 and the outer sheath 56.
As further shown in FIG. 12, the method of the present invention further comprises providing an anchor 72 and an anchor cable 82, wherein the anchor 72 and anchor cable 82 are inserted in the anchor catheter 58. The anchor cable 82 may be attached to the anchor 72, wherein the anchor cable 82 may be used for deploying the anchor 72 within the LAA wall 66. The anchor cable 82 may be a hollow coaxial cable standardly used in the industry. The anchor cable 82 and anchor 72 may encompass the delivery wire 60, wherein the delivery wire 60 may traverse through an inner lumen of the anchor 72 and an inner lumen of the anchor cable 82. The delivery wire 60 may be used to navigate the anchoring system 50 through the LAA 64. Alternatively, the anchor 72 and anchor cable 82 may be advanced through the anchor catheter 58 into the pericardial space 68 without using the delivery wire 60. The buddy wire 62 may remain inside the pericardial space 68 and is a safety feature in case of emergencies. The buddy wire 62 allows an interventional cardiologist to advance another catheter through the LAA wall 66 and place a plug within the small hole 70 if a malfunction is observed with the anchor 72 or the occluder device 80.
Illustrated in FIG. 13, the anchor 72 may be shaped like a sheave, comprising a first half 74, a second half 76, and a shaft 78 connecting the first half 74 to the second half 76, although it is contemplated that other anchor shapes may also be utilized in the present invention. The anchor 72 may be comprised of wire, wherein the first half 74 and second half 76 of the anchor 72 comprise wire mesh, further wherein the shaft 78 may comprise a single wire connecting the first half 75 wire mesh and the second half 76 wire mesh. The anchor 72 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. The anchor 72 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. The anchor 72 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 72 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. The anchor 72 may have a lumen wherein the delivery wire 60 traverses therein, alternatively, the anchor 72 may not have a lumen. The anchor 72 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
Illustrated in FIGS. 13A-B, the anchor 72 may have a contracted first position (FIG. 13A) and a deployed second position (FIG. 13B). In the contracted first position (FIG. 13A), the first half 74, second half 76, and shaft 78 of the anchor 72 have a diameter of approximately 1-5 mm and a length of approximately 5-55 mm. In the deployed second position (FIG. 13B), the first half 74 and second half 76 of the anchor 72 may expand outwards a distance of approximately 5-25 mm in diameter, wherein the shaft 78 remains approximately 1-5 mm in diameter. The anchor 72 may self-expand from the contracted first position (FIG. 13A) to the deployed second position (FIG. 13B).
Illustrated in FIG. 14, the method of the present invention comprises advancing the anchor 72 in the contracted first position (FIG. 13A) through the anchor catheter 58 using the anchor cable 82 and the delivery wire 60, wherein the anchor 72 extends into the pericardial space 68. The anchor catheter 58 may then be retracted, allowing the second half 76 of the anchor 72 to self-expand from the contracted first position to the deployed second position within the pericardial space 68. While the second half 76 of the anchor 72 is in the deployed second position, the shaft 78 and the first half 74 of the anchor 72 remain temporarily inside the anchor catheter 58.
Illustrated in FIG. 15, the method of the present invention further comprises retracting the anchor catheter 58, allowing the first half 74 of the anchor 72 to self-expand from the contracted first position to a partially deployed second position within the occluder device 80, wherein the occluder device 80 remains inside the outer sheath 56. The shaft 78 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66. The second half 76 of the anchor 72 remains in the deployed second position within the pericardial space 68, wherein the first half 74 of the anchor 72 is in the partially deployed second position within the occluder device 80. Alternatively, the anchor 72 and occluder device 80 may be integral, wherein the occluder device 80 may be a coil occluder device. Thus, the integral anchor 72 and occluder device 80 may be advanced together through the anchor catheter 58, wherein the anchor 72 is implanted in the LAA wall 66 using the system 50 of the present invention described above.
Illustrated in FIG. 16, the method of the present invention comprises retracting the outer sheath 56 to allow the occluder device 80 to expand inside the LAA 64. Moreover, retracting the outer sheath 56 allows the first half 74 of the anchor 72 to fully expand into the deployed second position within the occluder device 80. Thus, the shaft 78 of the anchor 72 may extend through the hole in the distal end of the occluder device 80, wherein the distal end of the occluder device 80 pinches down on the shaft 78. Furthermore, the first half of the anchor 74 in the deployed second position may pin the occluder device 80 against the LAA wall 66, wherein the anchor 72 effectively moors the occluder device 80 inside the LAA 64. At this time the expanded anchor 72 in the deployed second position covers a large surface area and therefore retains the occluder device 80 in an implanted position within the LAA 64. Moreover, by anchoring the occluder device 80 via the anchor 72 through all three layers of the LAA wall 66—instead of merely latching onto the thin endocardium layer—the method of the present invention lowers the risk of embolization. Here, the anchor cable 82 remains attached to the anchor 72 and the occluder cable 84 remains attached to the occluder device 80 in case problems arise after deployment of the occluder device 80. If no problems arise and it is determined that the occluder device 80 is in an optimal location of the LAA 64, the occluder cable 84 may be detached from the occluder device 80 and removed from the LAA 64. Furthermore, the anchor cable 82 may be detached from the anchor 72 and removed from the LAA 64. The buddy wire 62 and delivery wire 60 may also be withdrawn from the LAA 64, leaving the occluder device 80 anchored securely in the LAA 64 by the method of the present invention.
FIG. 17 illustrates the method of the present invention if problems arise after deployment of the occluder device 80. For instance, the method comprises making a determination that the occluder device 80 is not placed in an optimal location of the LAA 64 after deployment to achieve maximum occlusion. In this situation—prior to release of the occluder cable 84 from the occluder device 80 and the anchor cable 82 from the anchor 72—the outer sheath 56 may be advanced over the occluder device 80 to the LAA wall 66, wherein the occluder device 80 is retracted inside the outer sheath 56 using the occluder cable 82. The anchor catheter 58 may then be advanced to the LAA wall 66, wherein the first half 74 of the anchor 72 is retracted inside the anchor catheter 58 using the anchor cable 82. Thus, using the anchor cable 82, the first half 74 of the anchor 72 retracts from the deployed second position to the contracted first position to fit inside the anchor catheter 58. The outer sheath 56 containing the occluder device 80 may then be removed from the LAA 64, or the occluder device 80 may be re-deployed in a more optimal location of the LAA 64. If the occluder device 80 is removed from the LAA 64, the anchor catheter 58 may be retrieved thereafter, allowing the first half 74 of the anchor 72 to expand from the contracted first position to the deployed second position within the LAA 64. Thus, the deployed anchor 72 remains inside the LAA 64 and allows for occlusion of the small hole 70 that was created by the pericardial catheter 54 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 66.
Illustrated in FIG. 18, if a determination is made that optimal placement of the anchor 72 was not achieved, the anchor 72 may be released from the anchor cable 82 and deployed alone within the LAA wall 66 to plug the small hole 70 and prevent fluids from entering the pericardial space 68. The delivery wire 60 and buddy wire 62 may be subsequently removed from the LAA 64. This allows for a new anchor 72 to be placed within the LAA wall 66 using the method cited above for achieving optimal placement of the occluder device 80 within the LAA 64. On the other hand, if a determination is made that the anchor 72 is initially placed in an optimal location within the LAA wall 66 but there are problems with the occluder device 80, a second occluder device may be advanced over the inner sheath 58 and deployed within the LAA 64 using the method cited above. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device 80 into the LAA 64 using anchor 72, safely retrieve or re-deploy the occluder device 80 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 the LAA 24. After optimal placement of the occluder device 80 within the LAA 64 is achieved, the delivery wire 60 and buddy wire 62 may be removed from the LAA 64.
FIG. 19 illustrates yet a further aspect of the present invention, an anchoring system 90 for implanting and retrieving an occluder device within a LAA. The anchoring system 90 may comprise a pericardial catheter 94, wherein the pericardial catheter 94 may be a single or double-lumen pericardial catheter. The anchoring system 90 may further comprise an outer sheath 96 and an inner sheath 98. 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 pericardial catheter 94 may be configured to fit a delivery wire 100 and/or a buddy wire 102, also standardly used in the industry. A diameter of the delivery wire 100 may range between approximately 0.025-0.052 inches and a diameter of the buddy wire 102 may range between approximately 0.008-0.025 inches.
Further shown in FIG. 19, the outer sheath 96 may be inserted into LAA 104 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure to a LAA wall 106. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude the LAA 104 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath 96 within the LAA 104 and allow for better imaging of the LAA 104 by an interventional cardiologist. The pericardial catheter 94 may be advanced through the outer sheath 96 to the LAA wall 106. The buddy wire 102 is next advanced through the pericardial catheter 94 and the adjacent LAA wall 106, wherein the buddy wire 102 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into the pericardial space 108. The pericardial catheter 94 is next advanced over the buddy wire 104 and through the LAA wall 106, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into the pericardial space 108. Thus, the pericardial catheter 94 creates a small hole 110 through the LAA wall 106 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within the pericardial space 108 via the small hole 110. While the pericardial catheter 94 remains inside the pericardial space 108 via the small hole 110, the delivery wire 100 may then be advanced through the pericardial catheter 94, wherein the delivery wire 100 enters the pericardial space 108. The pericardial catheter 94 may then be removed from the outer sheath 96, leaving the delivery wire 100 and the buddy wire 102 inside the pericardial space 108 via the small hole 110 in the LAA wall 106.
Illustrated in FIG. 20, the anchoring system 90 of the present invention further comprises an occluder device 120 and an occluder cable 124. It is contemplated that the anchoring system 90 of the present invention may be used with a diverse range of LAA occluder devices 120 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 120 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, the occluder device 120 may have a distal end with a hole approximately 1-5 mm in diameter.
As shown in FIG. 20, the occluder cable 124 may be a hollow coaxial cable standardly used in the industry. The occluder cable 124 may be attached to the occluder device 120, wherein the occluder cable 124 may be used for deploying and retrieving the occluder device 120 within the LAA 104. The occluder device 120 and the occluder cable 124 may encompass the inner sheath 98, wherein the inner sheath 98 may traverse through an inner lumen of the occluder device 120 and an inner lumen of the occluder cable 124. The occluder device 120 may reside between the inner sheath 98 and the outer sheath 96.
As further shown in FIG. 20, the inner sheath 98 may be advanced through the outer sheath 96 to the LAA wall 106 adjacent the small hole 110. Particularly, the delivery wire 100 may traverse through the inner sheath 98, the occluder device 120, and the occluder cable 124. The buddy wire 102 may reside outside the inner sheath 98 and yet inside the outer sheath 96.
As also shown in FIG. 20, the inner sheath 98 may comprise an anchor 112 and an anchor cable 122. The anchor cable 122 may be attached to the anchor 112, wherein the anchor cable 122 may be used for deploying the anchor 112 within the LAA wall 106. The anchor cable 122 may be a hollow coaxial cable standardly used in the industry. The anchor cable 122 and anchor 112 may encompass the delivery wire 100, wherein the delivery wire 100 may traverse through an inner lumen of the anchor 112 and an inner lumen of the anchor cable 122. The delivery wire 100 may be used to navigate the anchoring system 90 through the LAA 104. Alternatively, the anchor 112 and anchor cable 122 may be advanced through the inner sheath 98 into the pericardial space 108 without using the delivery wire 100. The buddy wire 102 may remain inside the pericardial space 108 and is a safety feature in case of emergencies. The buddy wire 102 allows an interventional cardiologist to advance another catheter through the LAA wall 106 and place a plug within the small hole 110 if a malfunction is observed with the anchor 112 or the occluder device 120.
Illustrated in FIGS. 21A and 21B, the anchor 112 may have an elongate contracted first position (FIG. 21A) (e.g., straight—coil) when the delivery wire 100 is traversing the inner lumen of the anchor 112, and a deployed second position (FIG. 21B) (e.g., double-coil) when the delivery wire 100 has been removed from the inner lumen of the anchor 112. The delivery wire 100 when inside the inner lumen of the anchor 112 straightens the anchor 112 from its natural coiled state (deployed second position) into the elongated straight-coil (contracted first position). In the contracted first position (FIG. 21A), the anchor 112 has a diameter of approximately 0.5-2 mm and a length of approximately 2-40 mm. In the deployed second position (FIG. 21B), the anchor 112 may comprise a first coil 114, a second coil 116, wherein the first coil 114 and second coil 116 are connected together by a shaft 118. In the deployed second position (FIG. 21B), the first coil 114 and second coil 116 expand outwards a distance of approximately 5-15 mm in diameter, the shaft 118 remains approximately 0.5-2 mm in diameter, wherein the total length of the anchor 112 is approximately 1-10 mm. The anchor 112 may self-expand from the contracted first position (FIG. 21A) to the deployed second position (FIG. 21B).
Illustrated in FIG. 21B, the first coil 114 and second coil 116 of the anchor 112 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 coils 114, 116 may comprise a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The anchor 112 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. The anchor 112 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 112 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. The anchor 112 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
Illustrated in FIG. 22, the anchor 112 in the contracted first position (FIG. 21A) may be advanced through the inner sheath 98 using the anchor cable 122 and the delivery wire 100, wherein the anchor 112 is further advanced through the small hole 110 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into the pericardial space 68. The delivery wire 100 may then be retracted, allowing the second coil 116 of the anchor 112 to self-expand from the contracted first position to the deployed second position within the pericardial space 108. While the second coil 116 of the anchor 112 is in the deployed second position, the shaft 118 and the first coil 114 of the anchor 112 remain temporarily in the contracted first position.
Illustrated in FIG. 23, the inner sheath 98 adjacent the LAA wall 106 may be retracted along with the delivery wire 100, allowing the first coil 114 of the anchor 112 to self-expand from the contracted first position to a partially deployed second position within the occluder device 120. The occluder device 120 remains inside the outer sheath 96 adjacent the LAA wall 106. The shaft 118 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106. The second coil 116 of the anchor 112 remains in the deployed second position within the pericardial space 108, wherein the first coil 114 of the anchor 112 is in the partially deployed second position within the occluder device 120. Alternatively, the anchor 112 and occluder device 120 may be integral, wherein the occluder device 120 may be a coil occluder device. Thus, the integral anchor 112 and occluder device 120 may be advanced together through the inner sheath 98, wherein the anchor 112 is implanted in the LAA wall 106 using the system 90 of the present invention described above.
Illustrated in FIG. 24, the outer sheath 96 may be retracted to allow the occluder device 120 to expand inside the LAA 104. Moreover, retracting the outer sheath 96 allows the first coil 114 of the anchor 112 to fully expand into the deployed second position within the occluder device 120. Thus, the shaft 118 of the anchor 112 may extend through the hole in the distal end of the occluder device 120, wherein the distal end of the occluder device 120 pinches down on the shaft 118. Furthermore, the first coil 114 of the anchor 112 in the deployed second position may pin the occluder device 120 against the LAA wall 106, wherein the anchor 112 effectively moors the occluder device 120 inside the LAA 104. At this time the expanded anchor 112 in the deployed second position covers a large surface area and therefore retains the occluder device 120 in an implanted position within the LAA 104. Moreover, by anchoring the occluder device 120 via the anchor 112 through all three layers of the LAA wall 106—instead of merely latching onto the thin endocardium layer—the anchoring system 90 of the present invention lowers the risk of embolization. The second coil 116 located within the pericardial space 108 may unwind in a clockwise fashion, while the first coil 114 located in the LAA 104 may unwind in an reverse-clockwise fashion. Thus, there would be counter-forces acting on the coils, wherein the second coil 116 exerts proximal traction and the first coil 114 exerts distal traction against opposite sides of the LAA wall 106. Such counter-forces discourage the anchor 112 from unraveling while in the deployed second position within the LAA wall 106.
The anchor cable 122 remains attached to the anchor 112 and the occluder cable 124 remains attached to the occluder device 120 in case problems arise after deployment of the occluder device 120. If no problems arise and it is determined that the occluder device 120 is in an optimal location of the LAA 104, the occluder cable 124 may be detached from the occluder device 120 and removed from the LAA 104. Furthermore, the anchor cable 122 may be detached from the anchor 112 and removed from the LAA 104. The buddy wire 102 and delivery wire 100 may also be withdrawn from the LAA 106, leaving the occluder device 120 anchored securely in the LAA 104 by the anchoring system 90 of the present invention.
FIG. 25 illustrates the anchoring system 90 of the present invention if problems arise after deployment of the occluder device 120. For instance, it may be determined that the occluder device 120 is not placed in an optimal location of the LAA 104 after deployment to achieve maximum occlusion. In this situation—prior to release of the occluder cable 124 from the occluder device 120 and the anchor cable 122 from the anchor 112—the outer sheath 96 may be advanced over the occluder device 120, wherein the occluder device 120 is retracted inside the outer sheath 96 using the occluder cable 124. The delivery wire 100 may be further advanced through the anchor cable 112 and first coil 114 of the anchor 112, wherein the first coil 114 retracts from the deployed second position to the contracted first position and may be retrieved inside the inner sheath 98. The outer sheath 96 containing the occluder device 120 may then be removed from the LAA 104, or the occluder device 120 may be re-deployed in a more optimal location of the LAA 104. If the occluder device 120 is removed from the LAA 104, the delivery wire 100 may be retrieved thereafter, allowing the first coil 114 of the anchor 112 to re-expand from the contracted first position to the deployed second position within the LAA 104. Thus, the deployed anchor 112 remains inside the LAA 104 and allows for occlusion of the small hole 110 that was created by the pericardial catheter 94 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106.
Illustrated in FIG. 26, if optimal placement of the occluder device 120 was not achieved the anchor 112 may be released from the anchor cable 122 and deployed alone within the LAA wall 106. This allows for a new anchor 112 to be placed within the LAA wall 106 using the anchoring system 90 cited above for achieving optimal placement of the occluder device 120 within the LAA 104. On the other hand, if the anchor 112 is initially placed in an optimal location within the LAA wall 106 but there are problems with the occluder device 120, a second occluder device may be advanced using the inner sheath 98 and deployed within the LAA 104 using the anchoring system 90 cited above. Thus, the anchoring system 90 of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device 120 into the LAA 104 using anchor 112, safely retrieve or re-deploy the occluder device 120 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 the LAA 104. After optimal placement of the occluder device 120 within the LAA 104 is achieved, the delivery wire 100 and the buddy wire 102 may be removed from the LAA 104.
In another aspect of the present invention, an anchor 112 is provided for anchoring an occluder device 120 within a LAA 104. As illustrated in FIGS. 21A and 21B, the anchor 112 may have an elongate contracted first position (FIG. 21A) (e.g., straight—coil) when a delivery wire 100 is traversing an inner lumen of the anchor 112, and a deployed second position (FIG. 21B) (e.g., double-coil) when the delivery wire 100 has been removed from the inner lumen of the anchor 112. The delivery wire 100 when inside the inner lumen of the anchor 112 straightens the anchor 112 from its natural coiled state (deployed second position) into the elongated straight-coil (contracted first position). In the contracted first position (FIG. 21A), the anchor 112 has a diameter of approximately 0.5-2 mm and a length of approximately 2-40 mm. In the deployed second position (FIG. 21B), the anchor 112 may comprise a first coil 114, a second coil 116, wherein the first coil 114 and second coil 116 are connected together by a shaft 118. In the deployed second position (FIG. 21B), the first coil 114 and second coil 116 expand outwards a distance of approximately 5-15 mm in diameter, the shaft 118 remains approximately 0.5-2 mm in diameter, wherein the total length of the anchor 112 is approximately 1-10 mm. The anchor 112 may self-expand from the contracted first position (FIG. 21A) to the deployed second position (FIG. 21B).
Illustrated in FIG. 21B, the first coil 114 and second coil 116 of the anchor 112 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 coils 114, 116 may comprise a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The anchor 112 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. The anchor 112 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 112 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. The anchor 112 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
It is contemplated that the anchor 112 of the present invention may be used with a diverse range of LAA occluder devices 120 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 120 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, the occluder device 120 may have a distal end with a hole approximately 1-5 mm in diameter.
Illustrated in FIG. 22, the anchor 112 in the contracted first position (FIG. 21A) may be advanced through an inner sheath 98 using an anchor cable 122 and the delivery wire 100, wherein the anchor 112 is further advanced through a small hole 110 in an LAA wall 106 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into pericardial space 68. The delivery wire 100 may then be retracted, allowing the second coil 116 of the anchor 112 to self-expand from the contracted first position to the deployed second position within the pericardial space 108. While the second coil 116 of the anchor 112 is in the deployed second position, the shaft 118 and the first coil 114 of the anchor 112 remain temporarily in the contracted first position.
Illustrated in FIG. 23, the inner sheath 98 adjacent the LAA wall 106 may be retracted along with the delivery wire 100, allowing the first coil 114 of the anchor 112 to self-expand from the contracted first position to a partially deployed second position within the occluder device 120. The occluder device 120 remains inside an outer sheath 96 adjacent the LAA wall 106. The shaft 118 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106. The second coil 116 of the anchor 112 remains in the deployed second position within the pericardial space 108, wherein the first coil 114 of the anchor 112 is in the partially deployed second position within the occluder device 120. Alternatively, the anchor 112 and occluder device 120 may be integral, wherein the occluder device 120 may be a coil occluder device. Thus, the integral anchor 112 and occluder device 120 may be advanced together through the inner sheath 98, wherein the anchor 112 is implanted in the LAA wall 106 using the system 90 of the present invention described above.
Illustrated in FIG. 24, the outer sheath 96 may be retracted to allow the occluder device 120 to expand inside the LAA 104. Moreover, retracting the outer sheath 96 allows the first coil 114 of the anchor 112 to fully expand into the deployed second position within the occluder device 120. Thus, the shaft 118 of the anchor 112 may extend through the hole in the distal end of the occluder device 120, wherein the distal end of the occluder device 120 pinches down on the shaft 118. Furthermore, the first coil 114 of the anchor 112 in the deployed second position may pin the occluder device 120 against the LAA wall 106, wherein the anchor 112 effectively moors the occluder device 120 inside the LAA 104. At this time the expanded anchor 112 in the deployed second position covers a large surface area and therefore retains the occluder device 120 in an implanted position within the LAA 104. Moreover, by anchoring the occluder device 120 via the anchor 112 through all three layers of the LAA wall 106—instead of merely latching onto the thin endocardium layer—the anchoring system 90 of the present invention lowers the risk of embolization. The second coil 116 located within the pericardial space 108 may unwind in a clockwise fashion, while the first coil 114 located in the LAA 104 may unwind in an reverse-clockwise fashion. Thus, there would be counter-forces acting on the coils, wherein the second coil 116 exerts proximal traction and the first coil 114 exerts distal traction against opposite sides of the LAA wall 106. Such counter-forces discourage the anchor 112 from unraveling while in the deployed second position within the LAA wall 106.
The anchor cable 122 remains attached to the anchor 112 and an occluder cable 124 remains attached to the occluder device 120 in case problems arise after deployment of the occluder device 120. If no problems arise and it is determined that the occluder device 120 is in an optimal location of the LAA 104, the occluder cable 124 may be detached from the occluder device 120 and removed from the LAA 104. Furthermore, the anchor cable 122 may be detached from the anchor 112 and removed from the LAA 104. The delivery wire 100 and/or a buddy wire 102 may also be withdrawn from the LAA 106, leaving the occluder device 120 anchored securely in the LAA 104 by the anchoring system 90 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 in FIG. 19. The method of the present invention comprises providing an anchoring system 90. The anchoring system 90 may comprise a pericardial catheter 94, wherein the pericardial catheter 94 may be a single or double-lumen pericardial catheter. The anchoring system 90 may further comprise an outer sheath 96 and an inner sheath 98. 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 pericardial catheter 94 may be configured to fit a delivery wire 100 and/or a buddy wire 102, also standardly used in the industry. A diameter of the delivery wire 100 may range between approximately 0.025-0.052 inches and a diameter of the buddy wire 102 may range between approximately 0.008-0.025 inches.
Further shown in FIG. 19, the method of the present invention further comprises inserting the outer sheath 96 into LAA 104 via the left atrium proper of the heart by crossing the atrial septum using a transeptal procedure to the LAA wall 106. If a balloon-occlusion catheter has been utilized, the balloon occlusion may be expanded to occlude the LAA 104 from the left atrium proper. Expanding the balloon occlusion may improve stabilization of the outer sheath 96 within the LAA 104 and allow for better imaging of the LAA 104 by an interventional cardiologist. The pericardial catheter 94 may be advanced through the outer sheath 96 to the LAA wall 106. The buddy wire 102 is next advanced through the pericardial catheter 94 and the adjacent LAA wall 106, wherein the buddy wire 102 penetrates the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into the pericardial space 108. The pericardial catheter 94 is next advanced over the buddy wire 104 and through the LAA wall 106, penetrating the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into the pericardial space 108. Thus, the pericardial catheter 94 creates a small hole 110 through the LAA wall 106 of the heart. If utilized, the expanded balloon occlusion of the balloon-occlusion catheter decreases the likelihood of fluid accumulating within the pericardial space 108 via the small hole 110. While the pericardial catheter 94 remains inside the pericardial space 108 via the small hole 110, the delivery wire 100 may then be advanced through the pericardial catheter 94, wherein the delivery wire 100 enters the pericardial space 108. The pericardial catheter 94 may then be removed from the outer sheath 96, leaving the delivery wire 100 and the buddy wire 102 inside the pericardial space 108 via the small hole 110 in the LAA wall 106.
Illustrated in FIG. 20, the method of the present invention further comprises providing an occluder device 120 and an occluder cable 124. It is contemplated that the method of the present invention may be used with a diverse range of LAA occluder devices 120 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 120 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, the occluder device 120 may have a distal end with a hole approximately 1-5 mm in diameter.
As shown in FIG. 20, the occluder cable 124 may be a hollow coaxial cable standardly used in the industry. The occluder cable 124 may be attached to the occluder device 120, wherein the occluder cable 124 may be used for deploying and retrieving the occluder device 120 within the LAA 104. The occluder device 120 and the occluder cable 124 may encompass the inner sheath 98, wherein the inner sheath 98 may traverse through an inner lumen of the occluder device 120 and an inner lumen of the occluder cable 124. The occluder device 120 may reside between the inner sheath 98 and the outer sheath 96.
As further shown in FIG. 20, the method of the present invention comprises advancing the inner sheath 98 through the outer sheath 96 to the LAA wall 106 adjacent the small hole 110. Particularly, the delivery wire 100 may traverse through the inner sheath 98, the occluder device 120, and the occluder cable 124. The buddy wire 102 may reside outside the inner sheath 98 and yet inside the outer sheath 96.
Also shown in FIG. 20, the method of the present invention further comprises providing an anchor 112 and an anchor cable 122. The anchor cable 122 may be attached to the anchor 112, wherein the anchor cable 122 may be used for deploying the anchor 112 within the LAA wall 106. The anchor cable 122 may be a hollow coaxial cable standardly used in the industry. The anchor cable 122 and anchor 112 may encompass the delivery wire 100, wherein the delivery wire 100 may traverse through an inner lumen of the anchor 112 and an inner lumen of the anchor cable 122. The delivery wire 100 may be used to navigate the anchoring system 90 through the LAA 104. Alternatively, the anchor 112 and anchor cable 122 may be advanced through the inner sheath 98 into the pericardial space 108 without using the delivery wire 100. The buddy wire 102 may remain inside the pericardial space 108 and is a safety feature in case of emergencies. The buddy wire 102 allows an interventional cardiologist to advance another catheter through the LAA wall 106 and place a plug within the small hole 110 if a malfunction is observed with the anchor 112 or the occluder device 120.
Illustrated in FIGS. 21A and 21B, the anchor 112 may have an elongate contracted first position (FIG. 21A) (e.g., straight—coil) when the delivery wire 100 is traversing the inner lumen of the anchor 112, and a deployed second position (FIG. 21B) (e.g., double-coil) when the delivery wire 100 has been removed from the inner lumen of the anchor 112. The delivery wire 100 when inside the inner lumen of the anchor 112 straightens the anchor 112 from its natural coiled state (deployed second position) into the elongated straight-coil (contracted first position). In the contracted first position (FIG. 21A), the anchor 112 has a diameter of approximately 0.5-2 mm and a length of approximately 2-40 mm. In the deployed second position (FIG. 21B), the anchor 112 may comprise a first coil 114, a second coil 116, wherein the first coil 114 and second coil 116 are connected together by a shaft 118. In the deployed second position (FIG. 21B), the first coil 114 and second coil 116 expand outwards a distance of approximately 5-15 mm in diameter, the shaft 118 remains approximately 0.5-2 mm in diameter, wherein the total length of the anchor 112 is approximately 1-10 mm. The anchor 112 may self-expand from the contracted first position (FIG. 21A) to the deployed second position (FIG. 21B).
Illustrated in FIG. 21B, the first coil 114 and second coil 116 of the anchor 112 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 coils 114, 116 may comprise a square, rectangle, flat, sphere, circle, oval, pentagon, octagon, or any other shape. The anchor 112 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. The anchor 112 may be comprised of stainless steel, platinum, Nitinol, Elgiloy or other materials standardly used in the industry. The anchor 112 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. The anchor 112 may further include barbs, points, bristles, spurs, screws, hooks, pins, sutures, adhesives, pledgets, or other means of attachment.
Illustrated in FIG. 22, the method of the present invention comprises advancing the anchor 112 in the contracted first position (FIG. 21A) through the inner sheath 98 using the anchor cable 122 and the delivery wire 100, wherein the anchor 112 is further advanced through the small hole 110 to penetrate the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106 to extend into the pericardial space 68. The delivery wire 100 may then be retracted, allowing the second coil 116 of the anchor 112 to self-expand from the contracted first position to the deployed second position within the pericardial space 108. While the second coil 116 of the anchor 112 is in the deployed second position, the shaft 118 and the first coil 114 of the anchor 112 remain temporarily in the contracted first position.
Illustrated in FIG. 23, the method of the present invention comprises retracting the inner sheath 98 adjacent the LAA wall 106, along with the delivery wire 100, to allow the first coil 114 of the anchor 112 to self-expand from the contracted first position to a partially deployed second position within the occluder device 120. The occluder device 120 remains inside the outer sheath 96 adjacent the LAA wall 106. The shaft 118 resides inside the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106. The second coil 116 of the anchor 112 remains in the deployed second position within the pericardial space 108, wherein the first coil 114 of the anchor 112 is in the partially deployed second position within the occluder device 120. Alternatively, the anchor 112 and occluder device 120 may be integral, wherein the occluder device 120 may be a coil occluder device. Thus, the integral anchor 112 and occluder device 120 may be advanced together through the inner sheath 98, wherein the anchor 112 is implanted in the LAA wall 106 using the system 90 of the present invention described above.
Illustrated in FIG. 24, the method of the present invention comprises retracting the outer sheath 96 to allow the occluder device 120 to expand inside the LAA 104. Moreover, retracting the outer sheath 96 allows the first coil 114 of the anchor 112 to fully expand into the deployed second position within the occluder device 120. Thus, the shaft 118 of the anchor 112 may extend through the hole in the distal end of the occluder device 120, wherein the distal end of the occluder device 120 pinches down on the shaft 118. Furthermore, the first coil 114 of the anchor 112 in the deployed second position may pin the occluder device 120 against the LAA wall 106, wherein the anchor 112 effectively moors the occluder device 120 inside the LAA 104. At this time the expanded anchor 112 in the deployed second position covers a large surface area and therefore retains the occluder device 120 in an implanted position within the LAA 104. Moreover, by anchoring the occluder device 120 via the anchor 112 through all three layers of the LAA wall 106—instead of merely latching onto the thin endocardium layer—the method of the present invention lowers the risk of embolization. The second coil 116 located within the pericardial space 108 may unwind in a clockwise fashion, while the first coil 114 located in the LAA 104 may unwind in an reverse-clockwise fashion. Thus, there would be counter-forces acting on the coils, wherein the second coil 116 exerts proximal traction and the first coil 114 exerts distal traction against opposite sides of the LAA wall 106. Such counter-forces discourage the anchor 112 from unraveling while in the deployed second position within the LAA wall 106.
The anchor cable 122 remains attached to the anchor 112 and the occluder cable 124 remains attached to the occluder device 120 in case problems arise after deployment of the occluder device 120. If no problems arise and a determination is made that the occluder device 120 is in an optimal location of the LAA 104, the occluder cable 124 may be detached from the occluder device 120 and removed from the LAA 104. Furthermore, the anchor cable 122 may be detached from the anchor 112 and removed from the LAA 104. The buddy wire 102 and delivery wire 100 may also be withdrawn from the LAA 106, leaving the occluder device 120 anchored securely in the LAA 104 by the method of the present invention.
FIG. 25 illustrates the method of the present invention if problems arise after deployment of the occluder device 120. For instance, the method comprises making a determination that the occluder device 120 is not placed in an optimal location of the LAA 104 after deployment to achieve maximum occlusion. In this situation—prior to release of the occluder cable 124 from the occluder device 120 and the anchor cable 122 from the anchor 112—the outer sheath 96 may be advanced over the occluder device 120, wherein the occluder device 120 is retracted inside the outer sheath 96 using the occluder cable 124. The delivery wire 100 may be further advanced through the anchor cable 112 and first coil 114 of the anchor 112, wherein the first coil 114 retracts from the deployed second position to the contracted first position and may be retrieved inside the inner sheath 98. The outer sheath 96 containing the occluder device 120 may then be removed from the LAA 104, or the occluder device 120 may be re-deployed in a more optimal location of the LAA 104. If the occluder device 120 is removed from the LAA 104, the delivery wire 100 may be retrieved thereafter, allowing the first coil 114 of the anchor 112 to re-expand from the contracted first position to the deployed second position within the LAA 104. Thus, the deployed anchor 112 remains inside the LAA 104 and allows for occlusion of the small hole 110 that was created by the pericardial catheter 94 through the inner endocardium layer, middle myocardium layer, and outer epicardium layer of the LAA wall 106.
Illustrated in FIG. 26, if a determination is made that optimal placement of the anchor 112 was not achieved, the anchor 112 may be released from the anchor cable 122 and deployed alone within the LAA wall 106. This allows for a new anchor 112 to be placed within the LAA wall 106 using the method cited above for achieving optimal placement of the occluder device 120 within the LAA 104. On the other hand, if the anchor 112 is initially placed in an optimal location within the LAA wall 106 but there are problems with the occluder device 120, a second occluder device may be advanced using the inner sheath 98 and deployed within the LAA 104 using the method cited above. Thus, the method of the present invention allows an interventional cardiologist to quickly and cost-effectively implant the occluder device 120 into the LAA 104 using anchor 112, safely retrieve or re-deploy the occluder device 120 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 the LAA 104. After optimal placement of the occluder device 120 within the LAA 104 is achieved, the delivery wire 100 and the buddy wire 102 may be removed from the LAA 104.

Claims

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 of claim 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 of claim 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 of claim 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 of claim 1, wherein the anchor is self-expanding.

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

7. The anchoring system of claim 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 of claim 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 of claim 8, wherein the anchor comprises a coil.

10. The anchoring system of claim 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 of claim 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 of claim 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 of claim 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 of claim 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 of claim 15, wherein the anchor comprises a sheave shape.

17. The anchoring system of claim 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 of claim 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 of claim 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.