Minimally invasive occlusion device and method

Abstract

A minimally invasive occlusion device is disclosed. The minimally invasive occlusion device includes a first link having a first end and a second end, and a second link having a first end and a second end. The first end of the second link is coupled to the first end of the first link by a compensating coupler. Another minimally invasive occlusion device may include a shaft coupled to a delivery frame or articulating cradle. A method of tissue occlusion is also disclosed. The method includes positioning a first link of the occlusion device laterally at a tissue base, positioning a second link of the occlusion device opposite the tissue base and substantially parallel to the first link, and securing the first and second links to completely occlude the tissue base.

Description

[Technical Field]

[0001] The present invention relates to devices used for occlusion of anatomical structures, and more particularly to minimally invasive surgical devices used for occlusion of anatomical structures such as the left atrial appendage. [Background technology]

[0002] Atrial fibrillation (AF) is a common cardiac arrhythmia affecting millions of people. It is associated with ischemic stroke and increases the risk of stroke by as much as fivefold in patients with AF. AF leads to insufficient atrial contractions, reduced endurance, and an irregular heart rate. Inadequate blood flow within the left atrium leads to hypercoagulability, increasing the risk of thrombus formation. Left atrial appendage thrombosis and embolism are recognized as the primary mechanism of AF-associated stroke. This stroke mechanism may be correlated with reduced LAA flow velocity, thrombus formation, hypertension, and aortic atherosclerosis.

[0003] Left atrial appendage (LAA) 3-6 cm 2 It is an accessory chamber of the heart that extends into the left atrium and fills and empties in response to the action of both the ventricles and atria.Various morphologies of the left atrial appendage with respect to shape, volume, length, and width, specifically, a greater volume, depth, and number of lobes in the LAA, may be associated with the potential for thrombus formation.

[0004] Pharmacological anticoagulation, particularly with warfarin, is now recognized as a highly effective treatment for the medical management of patients with atrial fibrillation. While highly effective, warfarin use has a narrow therapeutic window and is associated with potential risks of major bleeding and pharmacological contraindications. When these risks or other barriers to anticoagulation outweigh the risk of stroke associated with atrial fibrillation, removal or isolation of the LAA represents an attractive alternative approach for preventing embolic events.

[0005] It is relatively straightforward to isolate the LAA from communication with the left atrium during other cardiac procedures. The LAA can be surgically occluded by ligation, plication, or sectioning. This procedure can be routinely performed on patients as an adjunct to heart valve surgery. Transvenous occlusion of the LAA is also a known approach to preventing embolism in patients with AF, utilizing catheter deployment of an implantable device to seal the ostium of the LAA. Percutaneous LAA occlusion is another known approach to occlude the LAA from blood flow and prevent thrombus formation and subsequent thromboembolic complications. Advantages of percutaneous LAA occlusion techniques include a less invasive procedure, faster recovery compared with surgical ligation, and a reduced risk of potential bleeding in the absence of anticoagulation. However, occlusion of the LAA remains challenging. Newer approaches to LAA occlusion are being developed but may be more complex and may increase the risk of LAA damage, incomplete occlusion, and device dislodgement.

[0006] Therefore, it would be desirable to have a reliable device and associated method for occluding the left atrial appendage. Ideally, such a device and method would be minimally invasive, yet deliverable via sternotomy, right lateral thoracotomy, or subxiphoid access. Furthermore, an occlusion device would be desirable that offers high efficacy with respect to a high probability of successful long-term occlusion, ease of use, and improved adaptation to individual anatomical variations, as well as the ability to reposition the device if initial delivery or placement is improper. Faster, more reliable cardiac surgery offers additional benefits, such as reduced fatigue for the surgical team and more efficient use of critical resources. Rapid cardiac surgery can also improve patient recovery. Summary of the Invention

[0007] A minimally invasive occlusion device is disclosed that includes a first link having a first end and a second end, and a second link having a first end and a second end, the first end of the second link being coupled to the first end of the first link by a compensating coupler.

[0008] Another minimally invasive occlusion device is disclosed. The minimally invasive occlusion device may include a delivery device. The minimally invasive occlusion device may include a delivery frame. The minimally invasive occlusion device may include a shaft and an articulating cradle coupled to the shaft. The minimally invasive occlusion delivery device may include a shaft, a first jaw coupled to the shaft, and a second jaw coupled to the shaft.

[0009] A method of tissue closure is disclosed that includes the steps of positioning a first link of a closure device laterally at a tissue base, positioning a second link of the closure device substantially parallel to the first link on an opposite side of the tissue base, and securing the first and second links to completely occlude the tissue base. [Brief explanation of the drawings]

[0010] [Figure 1A] FIG. 1 is a top, front left perspective view of one embodiment of a minimally invasive occlusion device. [Figure 1B] FIG. 2 is a perspective view of the minimally invasive occlusion device as viewed from above and from the right rear side.

[0011] [Figure 2A] 2 is a perspective view of an upper movable link of the minimally invasive occlusion device of FIG. 1. [Figure 2B] FIG.

[0012] [Figure 3A] FIG. 2C is a front view of the upper movable link of FIGS. 2A and 2B. [Figure 3B] FIG. [Figure 3C] FIG. [Figure 3D] FIG. [Figure 3E] FIG. [Figure 3F] FIG.

[0013] [Figure 4A] FIG. 2 is a perspective view of a lower tether link of the minimally invasive occlusion device of FIG. 1. [Figure 4B] FIG.

[0014] [Figure 5A] FIG. 4C is a front view of the lower mooring link of FIGS. 4A and 4B. [Figure 5B] FIG. [Figure 5C] FIG. [Figure 5D] FIG. [Figure 5E] FIG. [Figure 5F] FIG.

[0015] [Figure 6A] FIG. 2 is a front view of a delivery frame of the minimally invasive occlusion device of FIG. 1. [Figure 6B] FIG.

[0016] [Figure 7A] FIG. 2 is a rear view of the minimally invasive occlusion device of FIG. 1, illustrating the passage paths of various filaments. [Figure 7B] FIG. 2 is a front view of the minimally invasive occlusion device, showing the passage paths of various filaments. [Figure 7C] FIG. 2 is a front view of the minimally invasive occlusion device, showing the passage paths of various filaments.

[0017] [Figure 8A] 2A-2C are perspective views showing steps in a surgical sequence illustrating the use of the minimally invasive occlusion device of FIG. 1. [Figure 8B] 10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8C] 10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8D]10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8E] 10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8F] 10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8G] 10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8H] 10A and 10B are perspective views showing steps in the surgical sequence. [Figure 8J] 10A and 10B are perspective views showing steps in the surgical sequence.

[0018] [Figure 9] FIG. 10 is a perspective view of another embodiment of a minimally invasive occlusion device.

[0019] [Figure 10A] 10A-10C are perspective views of alternative embodiments of links for use in minimally invasive occlusion devices. [Figure 10B] 10A-10C are perspective views of alternative embodiments of links for use in minimally invasive occlusion devices.

[0020] [Figure 11] FIG. 10 is a top, front left perspective view of an alternative embodiment of a delivery device for a minimally invasive occlusion device.

[0021] [Figure 12] FIG. 12 is an exploded view showing assembly of the distal tip of the delivery device of FIG. 11.

[0022] [Figure 13A] FIG. 12 is a side view illustrating the operating principle of the delivery device of FIG. 11. [Figure 13B] FIG. 2 is a side view illustrating the operating principle of the delivery device.

[0023] [Figure 14A] FIG. 10 is a top, front left perspective view of an alternative embodiment of a distal tip of a delivery device for a minimally invasive occlusion device. [Figure 14B]FIG. 10 is a perspective view of the distal tip of the delivery device from below and from the left front side.

[0024] [Figure 15A] 14C is an exploded view showing the assembly process of the distal tip of the delivery device of FIG. 14A and FIG. 14B. [Figure 15B] FIG. [Figure 15C] FIG.

[0025] [Figure 16A] FIG. 14C is a side view illustrating the operating principle of the distal tip of the delivery device of FIGS. 14A and 14B. [Figure 16B] FIG. 2 is a side view illustrating the operating principle of the distal tip. [Figure 16C] FIG. 2 is a side view illustrating the operating principle of the distal tip.

[0026] It will be understood that for clarity, and where considered appropriate, reference numerals have been repeated among the figures to indicate corresponding features, and that the various components of the drawings have not necessarily been drawn to scale in order to better illustrate the features.

[0027] 1A and 1B are top, left, front, and top, right, rear perspective views, respectively, of an embodiment of a minimally invasive occlusion device. FIG. 1A is a top, left, front, and top, right, front perspective view of an embodiment of a minimally invasive occlusion device 10. The minimally invasive occlusion device 10 includes a delivery frame 12 molded from a plastic, transparent material. The delivery frame 12 defines a half cover or holder 24 that releasably holds a first movable link 26, a first filament channel 20, and a second filament channel 22. A second anchoring link 28 is also held to the frame by sutures but is not visible in this view (discussed below). The first, second, and third filament lumens 14, 16, and 18 are also held within the delivery frame 12 of the minimally invasive occlusion device 10. First filament channel 20 and second filament channel 22 are defined by delivery frame 12 and are configured to hold and guide a filament (or suture, or wire) through delivery frame 12, movable link 26, and tether link 28 until minimally invasive occlusion device 10 is deployed. FIG. 1B is a top, rear, right perspective view of the minimally invasive occlusion device embodiment of FIG. 1A. The delivery frame of minimally invasive occlusion device 10 defines a third filament channel 30. This third filament channel 30 is configured to hold and guide a filament (or suture, or wire) through delivery frame 12 and around tether link 28 until minimally invasive occlusion device 10 is deployed.

[0028] Although an embodiment of the minimally invasive occlusion device 10 is shown in FIGS. 1A and 1B, alternative embodiments of the minimally invasive occlusion device can have different sizes to accommodate the normal variations in left atrial appendage size for different patients. The delivery frame (also called a delivery card) is shown in FIGS. 1A and 1B as being substantially triangular in shape. Alternative embodiments of the minimally invasive occlusion device 10 may have different shapes, such as a square, rectangular, trapezoidal, or combinations thereof. Furthermore, although embodiments of the minimally invasive occlusion device have a delivery frame molded from a translucent plastic material to enable or improve visualization through the frame during the minimally invasive occlusion procedure, alternative embodiments may have a delivery frame made from materials such as stainless steel or other metals, or may have a delivery frame molded from a plastic composite or other plastic material. Furthermore, translucent plastic includes transparent materials, partially transparent plastics, and dyed or colored plastics. Suitable frame materials may include polycarbonate, polymethyl methacrylate, acrylic, polyethylene terephthalate (PET), amorphous copolyester (PETG), polyvinyl chloride (PVC), liquid silicone rubber (LSR), cyclic olefin copolymer, polyethylene (PE), and combinations thereof. Sutures are also referred to as tension members, tension filaments, wires, etc. It should be understood that the term "suture" as used herein is intended to encompass threads, cables, wires, filaments, strands, lines, yarns, gut, or similar structures, whether natural and / or synthetic, and whether in monofilament, composite filament, or multifilament (whether braided, woven, twisted, or otherwise) form. Equivalents, substitutions, combinations, and interchangeability of such materials and structures are also possible.

[0029] 2A and 2B are perspective views of an upper movable link of the minimally invasive occlusion device of FIG. 1. FIG. 2A is a perspective view from below of the first upper movable link of the minimally invasive occlusion device of FIG. 1. The movable link 26 is a single, integral link defining a cap 40 at one end and a chamfered cap 44 at the other end, with the caps 40, 44 connected by a beam 32. The cap 40 defines two filament apertures 52. The chamfered cap 44 defines a beveled surface 46 and two filament apertures 48. Adjacent to the cap 40 is a circumferential recess 42, and adjacent to the chamfered cap 44 is a circumferential recess 50. The two circumferential recesses 42, 50 are configured to hold and guide an anchoring filament (or anchoring suture), but are not shown in this view (as described below). The beam 32 has beam recesses 33 on both sides and a filament channel 34. The filament channel 34 has a branch 36 adjacent to the circumferential recess 42 adjacent to the cap 40 and a branch 38 adjacent to the circumferential recess 50 adjacent to the chamfered cap 44. The filament channel 34 is configured to hold and guide one or more sutures or filaments along the length of the movable link 26, leading from two filament apertures 52 through the branch 36, the filament channel 34, the branch 38, and to the filament aperture 48. The branches 36, 38 at either end of the movable link 26 are configured to facilitate free longitudinal movement of two separate filaments throughout the movable link 26. Although there may be contact between the two separate filaments threaded through the filament channel 34 of the movable link 26, the flared configuration of the branches 36, 38 toward the caps 40, 44 limits entanglement and frictional adhesion between the two filaments and allows multiple filaments (or sutures) to slide longitudinally within the channel 34 while the occlusion device and its movable link 26 and anchoring link 28 are positioned, adjusted, and tightened.

[0030] FIG. 2B is a top perspective view of the first upper movable link of FIG. 2A. FIG. 2B illustrates the respective locations of filament aperture 52 in cap 40 and filament aperture 48 in chamfered cap 44, as well as additional features of movable link 26 when viewed from above. The top surface of movable link 26 defines a central recess 54, several ridges 56 on either side of central recess 54, and several interrupted recesses 58 perpendicular to central recess 54 and ridges 56. These features combine to form gripping surfaces, thereby establishing interlocking surfaces of movable link 26 that mate with similar features on the top surface of the lower tether link. While the link shown in FIGS. 2A and 2B is substantially cylindrical, other embodiments of the link may be more or less rounded, rectangular, tubular, or flat relative to the embodiment shown in this figure. 3A, 3B, 3C, 3D, 3E, and 3F are front, left, right, back, top, and bottom views, respectively, of the upper movable link of FIGS. 2A and 2B. Alternate embodiments of the upper movable link may have alternative lengths to accommodate anatomical variations or other sizes associated with the left atrial appendage or other anatomical structures.

[0031] 4A and 4B are perspective views of a lower anchoring link of the minimally invasive occlusion device of FIG. 1. FIG. 4A is a perspective view from below of a second lower anchoring link of the minimally invasive occlusion device of FIG. 1. The anchoring link 28 is a single, integral link defining a cap 68 at one end and a chamfered cap 72 at the other end, with the caps 68, 72 connected by a beam 60. The cap 68 defines two filament apertures 80. The chamfered cap 72 defines a beveled surface 74 and two filament apertures 76. Adjacent to the cap 68 is a circumferential recess 70, and adjacent to the chamfered cap 72 is a circumferential recess 78. The two circumferential recesses 70, 78 are configured to hold and guide an anchoring filament (or anchoring suture), but are not shown in this view (as will be described later). On either side of the beam 60 are beam recesses 61 and filament channels 62. The filament channel 62 has a bifurcation 64 adjacent a circumferential recess 70 adjacent a cap 68 and a bifurcation 66 adjacent a circumferential recess 78 adjacent a chamfered cap 72. The filament channel 62 is configured to hold and guide one or more sutures or filaments along the length of the anchor link 28, leading from two filament apertures 80 through the bifurcation 64, the filament channel 62, the bifurcation 66, and back to the filament aperture 76. The bifurcation 64, 66 at each end of the anchor link 28 is configured to facilitate free movement of two separate filaments longitudinally throughout the anchor link 28. Although there may be contact between the two separate filaments threaded through the filament channel 62 of the anchoring link 28, the flared configuration of the branches 64, 66 toward the caps 68, 72 limits entanglement and frictional adhesion between the two filaments and allows multiple filaments (or sutures) within the channel 62 to slide longitudinally while the occlusion device and its movable link 26 and anchoring link 28 are positioned, adjusted, and tightened.

[0032] Figure 4B is a top perspective view of the second lower tether link of Figure 4A. Figure 4B shows the respective locations of the filament aperture 80 in cap 68 and the filament aperture 76 in chamfered cap 72, as well as additional features of the tether link 28 when viewed from above. The top surface of the tether link 28 defines a central protrusion 84, several ridges 86 on either side of the central protrusion 84, and several interrupted recesses 88 perpendicular to the central protrusion 84 and the ridges 86. These features form gripping surfaces, and thus establish mating surfaces of the tether link 28, that mate with similar features on the top surface of the upper movable link. While the link shown in Figures 4A and 4B is substantially cylindrical, other embodiments of the link may be more or less rounded, rectangular, tubular, or flat relative to the embodiment shown in this figure. Figures 5A, 5B, 5C, 5D, 5E, and 5F are front, left, right, back, top, and bottom views, respectively, of the lower tether link of Figures 4A and 4B. Alternate embodiments of the tether link may have alternative lengths to accommodate anatomical variations or other sizes associated with the left atrial appendage or other anatomical structures.

[0033] The combination of the first movable link, the second anchoring link, and the structure of the first and second links (each having a longitudinal filament channel) allows for a compensating coupler in the occlusion device of the present disclosure. The compensating coupler can connect or join the first and second links at either end, or, as in the illustrated embodiment, at both ends. In this embodiment, the filament or suture, combined with the internal filament channel and filament aperture structure at either end of each of the first and second links, creates the compensating coupler. While this compensating coupler is not a hinge or pivotable structure defined within the occlusion member, the structure formed by the two links can operate similarly to a hinge when the chamfered ends of the first and second links are clamped (or pulled) together by the filament (or suture) threaded through each of the first and second links.

[0034] Known hinged or spring-type occlusion devices may not adequately compensate for the varying pressure gradients applied to the tissue as the sides of the occlusion device close, starting from the hinge side and working toward the end. Other known occlusion devices may close from the end toward the hinge side, compressing the tissue. Others close in parallel with a fixed spring or rigid fixed tension member that forces two beams or links to close together, completing the occlusion of the tissue.

[0035] The disclosed embodiments have two independent beams secured at one or both ends by a compensating coupler (a variable-length, elastic, or flexible coupler, connecting means, or joint), allowing the beams to occlude the longer outer base of the left atrial appendage or other tissue surface with a substantially parallel closure plane rather than a triangular closure point with an increasingly acute angle at one end. In contrast to other devices that force parallel closure planes with a spring or other rigid tensioning member, the disclosed occlusion device provides a more consistent closure while tension is applied manually. The first or second link can rotate around anatomical variations in the morphology of the left atrial appendage or other structure. An advantage of the disclosed occlusion device is that it can provide a more consistent closure pressure along the length of the base of the left atrial appendage or other anatomical feature. Free-moving filaments in the upper and lower links provide operator-controllable levels of tension and slack to the occlusion when the occlusion device is tightened (tensioned). Because the closure mechanism operates simultaneously at both ends, the parallel beams are pulled together with the same force. However, the occlusion device is not strictly limited to parallel closure, nor is it limited to hinge-like, increasingly acute closure. A suture running through both beams allows for a dual-compensating coupler joint that manually applies approximately equal force to the tissue along the length of the link or beam for closure. Encapsulation of the entire base of the left atrial appendage is ensured by a combination of clamping force and ligation at the ends with filaments or sutures. Other materials, such as elastic or partially elastic filaments, can also be used.

[0036] 6A and 6B are front and rear views, respectively, of a delivery frame of an invasive occlusion device. FIG. 6A is a front view of the delivery frame 12 of the minimally invasive occlusion device 10 of FIG. 1. The delivery frame 12 defines a first protrusion 90. The first protrusion 90 further defines a first lumen recess 94 and a second lumen recess 98. The first lumen recess 94 is a partially cylindrical recess suitable for releasably retaining a tube or lumen. The first lumen recess 94 is bordered by two clips 96. The clips 96 are configured to partially surround a tube inserted into the first lumen recess 94 and prevent the inserted tube or lumen from prematurely dislodging. The second lumen recess 98 is also a partially cylindrical recess suitable for releasably retaining a tube or lumen. The second lumen recess 98 is bordered by two clips 100. These clips 100 are configured to partially surround an inserted tube and prevent unintentional or premature dislodgement of the inserted tube or lumen. Both the first lumen recess 94 and the second lumen recess 98 are in communication with the first filament channel 20 and the second filament channel 22. The first filament channel 20 branches off from the first lumen recess 94, its course including a first bend 102 and a second bend 104, and descends toward the triangular side 12A of the delivery frame 12, which holds the movable link 26. In addition to the half cover (or holder) 24 on the side 12A of the delivery frame 12, there is a movable link protrusion 140. This movable link protrusion 140 interfaces with the beam recess 33, thereby positioning the first movable link 26 (which was previously described with reference to FIG. 2A ) on the delivery frame 12. The first filament channel 20 is bordered by several filament clips 96A, 96B. These filament clips 96A, 96B help guide and retain the filament threaded within the first filament channel 20.

[0037] The second filament channel 22 branches primarily from the second lumen recess 98, its course including a first bend 106 and a second bend 108, down toward the side 12C of the triangular delivery frame 12, around a third bend 110, and toward the side 12B of the delivery frame 12. The frame side 12B defines a tether link protrusion 138 that interfaces with the beam recess 61 to position the second tether link 28 (which was previously described with reference to FIG. 4A ) on the delivery frame 12. The second filament channel 22 is bordered by several filament clips 100A, 100B. These filament clips 100A, 100B help guide and retain the filament threaded within the second filament channel 22. One end of frame side 12B (the end adjacent corner 120 between frame sides 12A and 12B) has two holes 112, 114. The other end of frame side 12B (the end adjacent corner 122 between frame sides 12B and 12C) has two additional holes 116, 118. The three sides 12A, 12B, 12C of triangular delivery frame 12 define opening 12D.

[0038] FIG. 6B is a rear view of the delivery frame 12 of the minimally invasive occlusion device 10 of FIG. 1. The first protrusion 90 and second protrusion 92 of the delivery frame 12 are shown from the back side of the delivery frame 12. The second protrusion 92 defines a third lumen recess 124. The third lumen recess 124 is a partially cylindrical recess suitable for releasably retaining a tube or lumen. The third lumen recess 124 is bordered by two clips 126. The clips 126 are configured to partially surround a tube inserted into the third lumen recess 124 and prevent the inserted tube or lumen from unintentionally or prematurely dislodging the inserted tube or lumen. The third lumen recess 124 is in communication with the third filament channel 30. The third filament channel 30 branches from the third lumen recess 124, and its course includes a first bend 128 and a second bend 132, descending toward the side 12C of the triangular delivery frame 12. The third filament channel 30 defines a first escape passage 130 and a second escape passage 134, respectively, before and after the second bend 132 at the corner 122 between the frame sides 12C and 12B. The first escape passage 130 and the second escape passage 134 provide an increased area within the third filament channel 30, thereby allowing additional space for the filament disposed within the third filament channel 30 and an increased radius for tightening around the second bend 132. The third filament channel 30 terminates in branches 136A and 136B, which communicate with the holes 116 and 118, respectively. The locations of holes 112, 114 near the opposite corner 120 are also shown in Figure 6B. The use and purpose of holes 112, 114, 116, 118 and third filament channel 30 will be discussed below.

[0039] 7A, 7B, and 7C are back, front, and front views, respectively, of the minimally invasive occlusion device of FIG. 1 , illustrating the paths of various filaments. FIG. 7A illustrates the paths of the filaments that hold the tether link 28 to the frame side 12B of the triangular delivery frame 12. The third filament lumen 18 is positioned within the third lumen recess 124 (not visible in this view) and is held in place within the third lumen recess 124 by two clips 126. The ripcord suture 142 exits the third filament lumen 18, courses around the first bend 128 of the third filament channel 30, down along the frame side 12C, around the second bend 132, along the bifurcation 136A, and into the additional hole 116. The ripcord suture 142 then courses around the circumferential recess 78 in the cap 72 of the tether link 28, returns through the hole 118, and follows the frame side 12B of the triangular delivery frame 12. As ripcord suture 142 is threaded along frame side 12B toward corner 120, it enters hole 114 and loops around circumferential recess 70 in cap 68 of anchor link 28. Ripcord suture 142 then loops back through hole 112, along frame side 12B, into bifurcation 136A, back around second bend 132 of third filament channel 30, around first bend 128, and back into third filament lumen 18.

[0040] FIG. 7B illustrates the filament threading path for the first suture (or first filament) used in the operation of the minimally invasive occlusion device of FIG. 1A. The first filament lumen 14 is positioned within the first lumen recess 94 of the first projection 90 and is held in place by two clips 96. The first suture 144 exits the first filament lumen 14, enters the first filament channel 20, passes around the second bend 104 of the first filament channel 20, and is threaded through one of the two filament apertures 52 in the cap 40 of the movable link 26. The suture passes through the internal channel of the first movable link 26, exits the filament aperture 48 in the chamfered cap 44, and enters directly into the filament aperture 76 in the chamfered cap 72 of the anchoring link 28. The suture passes through the internal channel of the anchoring link 28 and exits through the filament aperture 80 in the cap 68 at the end of the anchoring link 28. The first suture 144 then passes around the third bend 110 of the second filament channel 22, under the filament clip 100B, around the second bend 108 of the second filament channel 22, under the filament clip 100A, under the filament clip 96A, and finally back into the first filament lumen 14.

[0041] FIG. 7C shows the filament passage path for the second suture (or second filament) used in the operation of the minimally invasive occlusion device of FIG. 1A. The second filament lumen 16 is disposed within the second lumen recess 98 of the first protrusion 90 and is held in place by two clips 100. The second suture 146 exits the second filament lumen 16, enters the first filament channel 20, passes around the first bend 106 of the first filament channel 20, then passes through the second bend 104 of the first filament channel 20, passes under clip 96B, and enters one of the two filament apertures 52 of the cap 40 of the first movable link 26. The suture passes through the internal channel of the first movable link 26, exits through another filament aperture 48 of the chamfered cap 44, and enters directly into another filament aperture 76 of the chamfered cap 72 of the tethering link 28. The suture passes through the internal channel of the tethering link 28 and exits through one of the filament apertures 80 of the cap 68 at the end of the tethering link 28. The second suture 146 then passes around the third bend 110 of the second filament channel 22, passes under filament clip 100B, along the frame side 12C, around the second bend 108 of the second filament channel 22, passes under filament clip 100A, passes under filament clip 100A, and finally returns into the second filament lumen 16.

[0042] Figures 8A-8H and 8J are a series of perspective views showing a surgical sequence demonstrating the use of the minimally invasive occlusion device of FIG. 1. Note that FIG. 8I has been skipped to avoid confusion with the number 81. FIG. 8A is a schematic view of the heart 148, showing some of the features and anatomical components of the heart 148 associated with the left atrial appendage 166 (LAA) and the base 168 of the left atrial appendage 166. The relative positions of the superior vena cava 150, aorta 152, pulmonary trunk 164, and pulmonary veins 162 are shown in FIG. 8A. The positions of the right atrium 154, right ventricle 156, left ventricle 158, and left atrium 160 are also shown. In a surgical setting, the beating or non-beating heart 148 can be exposed or accessed by a median sternotomy or a unilateral sternotomy, and the surgeon accesses the surgical site from the right side of the patient.

[0043] FIG. 8B illustrates the placement of the minimally invasive occlusion device 10. The frame side 12B of the delivery frame 12 is positioned at its base 168 on the side of the left atrial appendage 166, avoiding contact with the pulmonary trunk 164 and pulmonary veins 162. The first, second, and third filament lumens 14, 16, and 18 are shown in cross section in this illustration, with the lumens 14, 16, and 18 (or tubes) extending generally posteriorly outside the surgical site. With the aid of a grasper 170, the left atrial appendage 166 is pulled through the opening 12D of the delivery frame 12 of the minimally invasive occlusion device 10. Using the grasper or fingers, the main body of the LAA 166 is retracted through the opening 12D of the delivery frame 12, while avoiding squeezing potential blood clots or wall deposits from the LAA 166 pocket. During this procedure, the surgeon must also avoid encircling or clamping the circumflex artery or coronary venous structures. Figure 8C illustrates the tether link 28 positioned parallel to the long axis or base 168 of the LAA 166, with the first and second filament lumens 14, 16 each released from the lumen recesses of the delivery frame 12 of the minimally invasive occlusion device 10. The ends of the first and second sutures 144, 146 emerge from the ends of the first and second filament lumens 14, 16, respectively. These sutures 144, 146 can be secured outside the patient's body using clamps, suture locking devices, or other means known to those skilled in the art.

[0044] 8D shows that the first movable link 26 of the minimally invasive occlusion device 10 has been released from its holder on the delivery frame 12 and rotated approximately 45 degrees to a position substantially parallel to the tether link 28. In this position, the first movable link 26 and the tether link 28 are also substantially parallel to the base 168 of the left atrial appendage 166. The end 144E of the first suture 144 and the end 146E of the second suture 146 are pulled in directions 172 and 174, respectively, to take up slack in the sutures 144, 146. Note that subsequent tightening or tensioning of the sutures 144, 146 is achieved by pulling in the same directions 172, 174. Prior to tightening the sutures 144, 146, the first movable link 26 can be better positioned along the left atrial appendage 166 using fingers, forceps, or graspers while encircling the entire base 168 structure of the left atrial appendage 166 with the first movable link 26, anchoring link 28, and sutures 144, 146. At this point, both sutures 144, 146 can be pulled through their respective lumens 14, 16 (or tubes) to tighten the first movable link 26 and anchoring link 28 around the left atrial appendage 166 and achieve complete occlusion. While tightening one suture should be sufficient to fully close the links 26, 28 together, the use of a second suture not only provides additional security but also provides a second tensioning member for securing the occlusion device in a later step when the occlusion device is finally secured with one or more mechanical fasteners. While the sutures may be tightened at this point, it should be noted that the suture clamps may be reversibly secured to allow for repositioning of the minimally invasive occlusion device 10 if the surgeon determines that repositioning is necessary, for example, through direct visual inspection, instrument visualization, or echosonography. The aforementioned compensating coupler, achieved through the construction of the first movable link 26, the tethering link 28, and the slidable sutures 144, 146 that move freely within the internal filament channels of the first movable link 26 and the tethering link 28, allows the minimally invasive occlusion device 10 to be adjustable when tightening the sutures to accommodate anatomical variations in the left atrial appendage 166 that may exist from patient to patient. This state of the minimally invasive occlusion device 10 is shown enlarged in FIG. 8E.

[0045] Figure 8F is an enlarged view of the surgical site shown in Figures 8A-8E. Once the occlusion device is in place and sufficient tension is applied to the occlusion device, the first filament lumen 14 can be removed, the suture ends are captured within a mechanical fastener device (not shown but known to those skilled in the art), and a first mechanical fastener 176 is applied to the first suture 144, fully securing the minimally invasive occlusion device 10 around the left atrial appendage 166. While the first mechanical fastener 176 is used, a hand-tied knot can also be used, although this is not recommended. Figure 8G is an enlarged view of the surgical site previously shown. Once the first mechanical fastener 176 is applied to the minimally invasive occlusion device 10, the second filament lumen 16 is removed, the ends of the sutures are captured within a mechanical fastening device (not shown but known to those skilled in the art), and a second mechanical fastener 178 is applied to the second suture 146, doubly securing the minimally invasive occlusion device 10 around the left atrial appendage 166. While a second mechanical fastener 178 is used, a hand-tied knot may also be used, although this is not recommended.

[0046] 8H is an enlarged view of the minimally invasive occlusion device 10 after the ripcord suture 142 has been removed by pulling one of its ends 142E in direction 180. The other end passes through a channel within the occlusion device and exits through the third filament lumen 18. With the ripcord suture 142 (or retention suture) removed, it no longer anchors the anchoring link 28 to the frame side 12B of the delivery frame 12. The third filament lumen 18 is then removed from the delivery frame 12 of the minimally invasive occlusion device 10. FIG. 8J illustrates the delivery frame 12 being removed in direction 182 from the left atrial appendage 166 and the surgical site. It should be noted that once the minimally invasive occlusion device 10 is secured to the base 168 of the left atrial appendage 166, the steps shown in Figures 8G, 8H, and 8J may be performed in a different order at the discretion of the surgeon.

[0047] FIG. 9 is a perspective view of another embodiment of a minimally invasive occlusion device. The minimally invasive occlusion device 184 includes a square-shaped delivery frame 186 molded from a plastic, transparent material. The delivery frame 186 defines a half cover or holder 188 that releasably holds the first movable link 26, a first filament channel 200, and a second filament channel 202. The second tether link 28 is also held to the frame 186 by a suture, not visible here. A first filament lumen 194, a second filament lumen 196, and a third filament lumen 198 are also held to the delivery frame 186 of the minimally invasive occlusion device 184. The first filament channel 200 and the second filament channel 202, defined by the delivery frame 186, hold and guide a filament (or suture, or wire) through the delivery frame 186, the movable link 26, and the tether link 28 until the minimally invasive occlusion device 184 is deployed. The delivery frame 186 also defines a third filament channel 204. The third filament channel 204 is also configured to hold and guide a filament (or suture, or wire) through the delivery frame 186 and around the tether link 28 until the minimally invasive occlusion device 10 is deployed. There is also an opening 206 in the delivery frame 186 for retracting the left atrial appendage or other tissue structure through the frame for occlusion. The minimally invasive occlusion device 184 of this embodiment has an arcuate closure guide 208 defined by the frame 186, which serves the purpose of assisting the operator in controlling the closure of the first movable link 26 onto the tether link 28 during use. This operation and deployment of the minimally invasive occlusion device 184 of this embodiment is similar to the previously described embodiments.

[0048] 10A-10B are perspective views of alternative embodiments of links for use in minimally invasive occlusion devices. Another embodiment of a set of links 210 is shown in the closed position in FIG. 10A. The position of the end caps on the first link 212 and the second link 214 is shown. This embodiment is shown with a woven cover 216 encapsulating both links. The woven cover can be constructed from polymer fibers such as polyethylene terephthalate, polyethylene glycol, caprolactone, and the like. The polymer fiber cover can also be in the form of mesh, monofilament, multifilament, braid, and other applicable polymer fibers. These types of covers or sheaths can help improve healing by promoting sealing of the occlusion device and other medical obturators similar to those described herein. FIG. 10B shows another alternative embodiment of a set of links 218 in the closed position. 10B shows the location of first link end cap 220, first link sheath 222, first link chamfered end cap 224, second link end cap 226, second link sheath 228, and second link chamfered end cap 230. Sheaths 222, 228 can be made from a variety of polymeric materials suitable for promoting and assisting healing near the occlusion device, similar to the composition and functionality of the woven covering described in connection with FIG.

[0049] While several embodiments of delivery frames have been described herein, other delivery devices may be used to deliver the links and occlusion devices described herein. For example, the delivery device may include a handle, a shaft, a release mechanism, and various tips useful for introducing the occlusion device. One example of a suitable tip for such a delivery device may include an articulating cradle coupled to the shaft. Another example of a tip for such a delivery device may include a first jaw, a second jaw, and a means for articulating the jaws to effectively and accurately deliver the occlusion device to the intended surgical field.

[0050] 11 is a top, left, front perspective view of an alternative embodiment of a delivery device for a minimally invasive occlusion device. The delivery device 232 (or introducer) includes a housing 234, a handle 236, and an actuator lever 238 at its proximal end 232P. The delivery device 232 (or introducer) also includes a rotating adapter 240, a first articulation knob 242, and a second articulation knob 244. The rotating adapter 240 rotates the entire distal end 232D of the delivery device 232 about the axis of a shaft 250. The shaft 250 is coupled to the housing 234 at the end of the second articulation knob 244. The rotating adapter 240 and the first articulation knob 242 and second articulation knob 244 are attached to the housing 234 using a retainer 246. The retainer 246 can be secured to the shaft 250 by adhesive, welding, or other means known to those skilled in the art. The shaft also includes a suture lock mount 248. The suture lock mount 248 is configured to hold two side suture locks 254, 258 and two top suture locks 260, 262. The suture locks 254, 258, 260, 262 are configured to hold and releasably lock a suture threaded therethrough. One suture lock 254 is visible with a pull tab 256. This pull tab 256 may be attached to the proximal end of a suture and is used to pull the suture proximally during a procedure using such suture lock 254. While only one pull tab 256 is visible in this view, in alternative embodiments, it may or may not be part of each of the suture locks 254, 258, 260, 262. A suture tube 270, 268, 264, 266 protrudes from each suture lock 254, 258, 260, 262, respectively. The suture tubes 270, 268, 264, 266 hold sutures or other suitable filaments therein and aid in organizing the sutures during minimally invasive surgical procedures associated with the delivery device 232. Along the shaft 250 is a suture tube guide 252, which defines a number of notches 272 around its circumference.These notches 272 releasably retain several suture tubes 270, 268, 264, 266 proximal to the shaft 250 prior to use of the delivery device 232. Additionally, toward the distal end 232D of the delivery device 232 is a first articulation joint 276. The first articulation joint 276 is movable in a first plane of articulation 278 by actuation of the first articulation knob 242. A second shaft 274 is connected to the first articulation joint 276. A second articulation joint 280 is connected to the second shaft 274. The second articulation joint 280 is movable in a second plane of articulation 282 by actuation of the second articulation knob 244. The second articulation joint 280 is defined by a distal housing 314. The distal housing 314 further defines opposite side suture tube guides 284 and two upper suture tube guides 288. These suture tube guides 284, 286, 288 releasably hold the suture tubes proximal to the distal housing 314, where the sutures exit the suture tubes 270, 268, 264, 266. Also attached to the distal housing 314 are two articulating jaws: a first jaw 290 that holds a first link 296, and a second jaw 292 that holds a second link 298. At the ends of the first and second jaws 290, 292 are suture targets 300. The suture targets 300 define first and second suture grooves 302, 304. These grooves hold the sutures in place until the delivery device 232 is used. Two sutures (not visible in this view) are held in upper suture locks 260, 262 within suture tubes 264, 268, respectively, and exit the suture tubes 264, 268, connecting a first link 296 to the first jaw 290 and a second link 298 to the second jaw 292.

[0051] Two sutures (not visible in this view) are held within suture tubes 270, 266 and side suture locks 254, 258, respectively, and are threaded out of the suture tubes 270, 266, through first and second links 296, 298, and then through suture target 300. The threading and installation of the links 296, 298 of this delivery device 232 into the left atrial appendage for occlusion is similar to the threading process described in the previous embodiments described herein. The delivery device 232 is used to introduce the links 296, 298 around the base of the left atrial appendage, rather than the card or frame delivery devices previously described. The elongated, articulating jaw embodiment of the left atrial appendage occlusion delivery device 232 allows for less invasive introduction into spaces other than a full sternotomy (e.g., a subxiphoid approach or a right lateral mini-thoracotomy). Note that the delivery device 232 is configured so that the links 296, 298 are loaded into the jaws 290, 292 in a facing, closed position relative to one another. During deployment and use of the delivery device 232, the links 296, 298 first open and then rotate toward one another, narrowing the angle between them until they provide resistance in closure around tissue, such as the left atrial appendage. At this point, the links may be released from the jaws 290, 292, and a compensating coupler mechanism allows the folded or joined portions of the two links 296, 298 to accommodate various anatomical variations and sizes of the tissue structure to be occluded. This feature provides a closure around the left atrial appendage or other tissue structure such that the two links 296, 298 are parallel, nearly parallel, or substantially parallel when tightened with a filament or suture independently of the delivery device 232.

[0052] Figure 12 is an exploded view illustrating the distal assembly of the delivery device of Figure 11. At the end of shaft 250 and first articulation joint 276 is second shaft 274. Second shaft 274 has a hinge 316 at its end defining two axles 318 and a distally projecting second articulation control rod 324. A pusher rod 376 also projects distally. A distal housing cover 294 is disposed on axle 318 along axis 322. Distal housing cover 294 defines an internal recess 320 configured to receive a pusher 326. The pusher 326 is disposed on pusher rod 376 along axis 330 and is slidable distally and proximally within recess 320 in distal housing cover 294. First jaw 290 defines a jaw hinge 336 having a slot 334 and a pivot hole 348. First jaw 290 is disposed within pusher 326 along axis 359. First jaw 290 also defines a jaw recess 350, a jaw end 354, and a suture recess 356 in jaw end 354. Second jaw 292 defines a jaw hinge 344 having a slot 342 and a pivot hole 346. Second jaw 292 is disposed within pusher 326 along axis 358. Second jaw 292 also defines a jaw recess 352, a jaw end 360, and a suture recess 362 in jaw end 360. Once the pusher 326 is placed on the pusher rod 376 and the jaws 209, 292 are positioned within the pusher 326, a pin 328 is positioned through a top hole 340 defined in the pusher 326, through a slot 342 in the second jaw 292, and through a slot 334 in the first jaw 290 to secure the pin 328 to the end of the pusher rod 376. The jaws 290, 292 are assembled by placing the pivot pin 332 through the hole 346 in the second jaw 292 and through the hole 348 in the first jaw 290. The distal housing 314 is then attached to the axle 318 of the hinge 316 and the distal housing cover 294, thereby capturing the pusher 326, pin 332, jaw hinge 344, and jaw hinge 336 within the distal housing.As the pusher rod 376 moves proximally by squeezing the delivery device's actuation lever, the jaws 290, 292 move from the open position to the closed position, as will be described in more detail below. The sheath 368 is attached to the first link 296 by inserting the first link 296 into the center 372 of the sheath 368 along axis 364. The sheath 370 is attached to the second link 298 by inserting the second link 298 into the center 374 of the sheath 370 along axis 366. The link 296 is positioned in the jaw recess 350 of the first jaw 290 along axis 365, and the link 298 is positioned in the jaw recess 352 of the second jaw 292 along axis 367, completing the assembly of the delivery device. The links 296, 298 are then secured to the jaws 290, 292 using the sutures described above.

[0053] 13A and 13B are side views illustrating the operating principle of the delivery device of FIG. 11. In a minimally invasive surgical procedure for occluding the left atrial appendage, a delivery device 232 is used to deliver an occlusion structure to the base of the left atrial appendage (LAA). With the surgeon positioned on the patient's right side, the left atrial appendage is exposed using a beating or stopped heart and subxiphoid access to the great vessels. The target 300 is removed, and the retained suture loop is passed around the left atrial appendage with the aid of a grasper or other surgical instrument capable of holding or grasping the left atrial appendage. The delivery device 232 is passed along the suture loop toward the left atrial appendage using a Seldinger-like technique. Near the LAA, the suture is unlocked and the jaws open. The suture loop, threaded through both links 296, 298 of the delivery device 232, is passed over and around the base of the LAA. If the LAA ostium is eccentric or oval, the rotating adapter 240 and the first and second articulation knobs 242 and 244 are used to position both links 296 and 298 parallel to the long axis of the LAA ostium. The actuator lever 238 is pulled in the direction 378 toward the handle 236 of the delivery device 232, avoiding contact between the flat surfaces of both links 296 and 298, which are perpendicular and adjacent to the superior LAA / LA boundary, and the pulmonary artery and pulmonary veins. The first jaw 290 and the right second jaw 292 are closed around the base of the left atrial appendage, avoiding squeezing any potential clots or their wall attachments from the LAA pocket. Additional care must be taken to avoid encircling or clamping the circumflex artery or coronary venous structures. Figure 13B shows the orientation and appearance of the delivery device 232 when in the closed position. With both links 296, 298 approximately aligned around the ostium and flush against the edges of the LAA, one of the upper suture locks 260, 262 is tightened to tighten the sutures and secure the links in place. The second of the two upper suture locks 260, 262 is then tightened to tighten the sutures and double-secure the links 296, 298. Proper placement of the links is verified by visual and / or video inspection and echosonography. Once the links are positioned, titanium fasteners are placed on each of the sutures holding the links 296, 298 in place. Alternatively, hand-tied knots or other fastening means may be used.Next, the two remaining sutures anchoring links 296, 298 to delivery device jaws 290, 292 are removed. Finally, delivery device 232 is removed from the surgical field. While the general steps for use of delivery device 232 in Figure 11 have been described, they may be performed in a different order depending on the surgeon's preference or the conditions of the surgical field.

[0054] Figures 14A and 14B show top and bottom left front perspective views, respectively, of an alternative embodiment of a distal tip of a delivery device for a minimally invasive occlusion device. Figures 14A and 14B show an introducer device having an introducer sheath distal tip 380 for introducing or delivering an occlusion device for the left atrial appendage. A second articulation joint 382 of an instrument similar to delivery device 232 shown and described in Figures 11-13B is shown. Connected to second articulation joint 382 is a cradle 384 for holding first link 390, which is covered by sheath 392. Cradle 384 further defines several suture apertures 394, 396, 398, and 400, configured to pass sutures through the apertures for anchoring and securing first link 390 to cradle 384. A deployment cap 386 is positioned toward the distal end 380D of the introducer sheath distal tip 380. The deployment cap 386 defines a hook 388. The cylindrical deployment cap 386 is sometimes referred to as a sheath or cylindrical cap. The deployment cap 386 is positioned to cover the second link (not visible in this view) and a portion of the first link 390. FIG. 14B is a bottom, front, left perspective view of the introducer sheath distal tip 380 of FIG. 14A, showing the deployment cap's suture aperture 446. The suture aperture is configured to pass a suture through the suture aperture for securing the deployment cap to the introducer sheath distal tip 380. A cradle stop 385 is defined in the cradle 384 to limit the insertion depth of the deployment cap 386 over the first link 390.

[0055] Figures 15A-15C are exploded views illustrating assembly of the distal tip of the delivery device of Figures 14A and 14B. Figure 15A illustrates the insertion of the second movable link 406 into the sheath 408 along the axis 410. Figure 15B illustrates the insertion of the first tether link 390 into the sheath 392 along the axis 404. Figure 15C illustrates the remaining assembly steps of the distal tip of the delivery device of Figures 14A and 14B. A first articulation joint 414 is coupled to the shaft 416, a second shaft 418 is coupled to the first articulation joint 414, and a hinge 420 is coupled to the second shaft 418. The hinge 420 further defines two axle portions 422 and has a barrel 430 protruding from its end. The housing cover 424 further defines a bore 432. The housing cover 424 is attached to the axle portions 422 along the axis 428. Cradle 384 further defines housing portion 442, post 434, hole 436, slot 438, and recess 440. The cradle is attached to shaft portion 422 along axis 428, with recess 440 mating with shaft portion 422, post 434 mating with hole 432 in housing cover 424, and slot 438 mating with hinge 420. Next, first link 390 with sheath 392 is positioned on cradle 384 along axis 412, and movable link 406 with sheath 408 is positioned end-to-end with first link 390 along axis 412. Finally, deployment cap 386 is positioned on the ends of movable link 406 and first link 390 along axis 412. Although not shown in this view, the first link 390 is connected to the cradle 384 by a filament or suture, and the deployment cap 386 is also connected to the cradle 384 by a filament or suture. Note that the introducer sheath distal tip 380 is configured so that the links 390, 406 are loaded end-to-end into the cradle 384 and are in a straight or 180 degree position relative to each other. As the introducer sheath distal tip 380 is deployed and used, the links 390, 406 rotate toward each other, narrowing the angle between the links 390, 406 until resistance is encountered in closing around tissue, such as the left atrial appendage.The compensating coupler mechanism then allows the folding or joining of the two links 390, 406 to accommodate various anatomical variations and sizes of the tissue structure to be occluded. This feature provides a parallel, near-parallel, or substantially parallel closure of the two links 390, 406 around the left atrial appendage or other tissue structure when tightened by a filament or suture, independent of the introducer sheath distal tip 380.

[0056] Figures 16A-16C are side views illustrating the operating principle of the distal tip of the delivery device of Figures 14A and 14B. While shown without the presence of living tissue, the procedure is similar to that previously described with respect to Figures 8A-8H and 8J. In minimally invasive surgery for occlusion of the left atrial appendage, the introducer sheath distal tip 380 is used to deliver the occlusion device to the base of the left atrial appendage (LAA) while at the distal end of the minimally invasive surgical device. In a procedure using a right lateral mini-thoracotomy, access to the beating or stopped heart and great vessels is gained, and the left atrial appendage is exposed via the transverse sinus. A grasper or other appropriate surgical instrument is used to hold the LAA and facilitate occlusion with the introducer sheath distal tip 380. The introducer sheath distal tip 380 is passed over the base of the LAA while the LAA is grasped or held in place. A second grasper can be placed below the LAA to grasp the hook 388 of the fixed introducer sheath distal tip 380. There are two suture locks (not shown in this view) that hold the deployment cap 386 to the end of the introducer sheath distal tip 380 by threading the suture through the suture aperture 446 in the deployment cap. The suture locks are unlocked to release the deployment cap 386, which is then slid, along with the captured suture, in direction 444 toward the distal end 380D of the introducer sheath distal tip 380, axially away from the movable link 406. See FIG. 16A. The deployment cap 386, along with the captured suture, is removed from the surgical field. The captured suture (whose other end is threaded through the anchoring link 390 and the movable link 406) is released from the suture aperture 446 in the deployment cap 386.

[0057] The flat surface of the tether link 390 is positioned perpendicular to and adjacent to the base of the left atrial appendage, avoiding contact with the pulmonary artery and left superior pulmonary vein. Figures 16A-16C are side views illustrating the operating principle of the distal tip of the delivery device of Figures 14A-14B. While shown without live tissue, the procedure is similar to that previously described. In minimally invasive surgery for left atrial appendage occlusion, the introducer sheath distal tip 380 is used to deliver the occlusion device to the base of the left atrial appendage (LAA) while at the distal end of the minimally invasive surgical device. In a procedure using a right lateral mini-thoracotomy, access to the beating or stopped heart and great vessels is gained, and the left atrial appendage is exposed via the transverse sinus. A grasper or other appropriate surgical instrument is used to hold the LAA and facilitate occlusion with the introducer sheath distal tip 380. The introducer sheath distal tip 380 is passed over the base of the LAA while the LAA is grasped or held in place. A second grasper can be positioned below the LAA to grasp the hook 388 of the fixed introducer sheath distal tip 380. There are two suture locks (not shown in this view) that hold the deployment cap 386 to the end of the introducer sheath distal tip 380 by threading a suture through the deployment cap's suture aperture 446. The suture locks are unlocked to release the deployment cap 386, which is then slid axially away from the movable link 406 in direction 444 toward the distal end 380D of the introducer sheath distal tip 380, along with the captured suture. See FIG. 16A. The deployment cap 386, along with the captured suture, is removed from the surgical field. The captured suture (whose other end is threaded through the anchoring link 390 and the movable link 406) is released from the suture aperture 446 of the deployment cap 386.

[0058] If an eccentric or oval ostium is present, use the adjustment option to position the tethering link 390 parallel to the long axis of the left atrial appendage ostium. The mobile link 406 is tensioned and positioned under the grasper on the opposite side of the LAA. Using a second grasper, the mobile link 406 is positioned opposite the tethering link 390 and carried around the LAA in direction 448, avoiding squeezing potential clots or wall deposits from the LAA 166 pocket. The placement of the tethering link 390 and mobile link 406 is shown in Figure 16B. It is important to avoid encircling or clamping the circumflex artery or coronary venous structures during this step of the procedure. Once both links 390, 406 are approximately aligned around the perimeter of the left atrial appendage ostium and flush against the edge of the LAA, one of the sutures threaded through the links 390, 406 is tightened to secure the links in place. The second suture is then tightened to double-secure the links 390, 406 together, as shown in FIG. 16C. Proper placement of the links is verified by visual and / or video inspection and echosonography. At this point, if repositioning is necessary, the sutures can be loosened and the links 390, 406 can be repositioned to the desired location. Once positioned, titanium fasteners are placed on each of the sutures to hold the links 390, 406 in place. Alternatively, hand-tied knots or other fastening means may be used. The remaining sutures anchoring the anchoring link 390 to the cradle 384 are then removed. Finally, the introducer sheath distal tip 380 is removed from the surgical field in direction 450, as shown in FIG. 16C. The general steps for using a delivery device with an introducer sheath distal tip 380 are similar to those shown in FIGS. 14A and 14B, but may be performed in a different order depending on the surgeon's preference or the circumstances of the surgical field.

[0059] Various advantages of minimally invasive occlusion devices and related methods have been discussed above. The embodiments discussed herein are described by way of example. Those skilled in the art will appreciate that the foregoing detailed disclosure is intended to be presented by way of example only, and not by way of limitation. Although not expressly described herein, various changes, improvements, and modifications will occur and will occur to those skilled in the art. These changes, improvements, and modifications are intended to be suggested by this disclosure and are within the spirit and scope of the invention as defined by the appended claims. The drawings included in this disclosure are not necessarily drawn to scale. Furthermore, the listed order of process elements or sequences, or the use of numbers, letters, or other elements, is not intended to limit the claims to any order, unless specified in the claims. Therefore, it is intended that this invention be limited only by the claims and the equivalents thereof.

Claims

1. an occlusion device for occluding the left atrial appendage of a patient; and a delivery device; The occlusion device comprises: an elongated first link having a first end and a second end; an elongated second link having a first end and a second end; Equipped with the delivery device comprises a rigid frame having a receiving opening for receiving at least a portion of a patient's left atrial appendage, the receiving opening having first, second, and third edges that form a triangular shape, the first link of the occlusion device being removably coupled to a first portion of the frame parallel to the first edge of the receiving opening, and the second link of the occlusion device being removably coupled to a second portion of the frame parallel to the second edge of the receiving opening; When the first and second links are coupled to the frame, the first end of the first link and the first end of the second link are disposed adjacent to each other, the first link and the second link each having a longitudinally extending filament channel; the first end and the second end of the first link have first and second apertures, respectively, that communicate with the filament channel of the first link; the first end and the second end of the second link have third and fourth apertures, respectively, that communicate with the filament channel of the second link; the closure device further comprises a filament, the filament being arranged to slidably pass through the second aperture, the filament channel, and the first aperture in the first link, in sequence, and to slidably pass through the third aperture, the filament channel, and the fourth aperture in the second link, in sequence; the first end of the first link and the first end of the second link are connected by the filament; The filament between the first end of the first link and the first end of the second link is provided as a variable length compensating coupler.

2. A minimally invasive surgical assembly as described in claim 1, wherein the first link is detachably connected to the first portion of the frame by a half cover or holder, and the second link is detachably connected to the second portion of the frame by a mooring filament.

3. The frame has a first filament channel and a second filament channel; one end of the first filament channel communicates with the second aperture of the first link when the first link is detachably coupled to the first portion of the frame; one end of the second filament channel communicates with the fourth aperture of the second link when the second link is detachably coupled to the second portion of the frame; a portion of the filament is releasably and slidably inserted through the first filament channel and led out of the frame, and another portion of the filament is releasably and slidably inserted through the second filament channel and led out of the frame; The minimally invasive surgical assembly of claim 1 , wherein the one portion and the other portion of the guided filament are threaded through a common lumen.

4. Further comprising a mooring filament, First and second holes are formed in one end of the second portion of the frame, and third and fourth holes are formed in the other end of the second portion, the mooring filament has two portions extending along the second portion and reciprocating between the one end and the other end, a portion inserted through the first and second holes, and a portion inserted through the third and fourth holes; 2. The minimally invasive surgical assembly of claim 1, wherein the anchoring filament holds the first end of the second link between the first and second holes and holds the second end of the second link between the third and fourth holes.

5. A minimally invasive surgical assembly as described in claim 4, wherein the frame has a third filament channel through which the tethering filament is releasably and slidably inserted.

6. The minimally invasive surgical assembly of claim 1 , wherein the first link and the second link each have opposing interlocking surfaces.

7. The minimally invasive surgical assembly of claim 1 , wherein the frame is constructed from a transparent or transparent material.

Images