The present disclosure relates generally to medical devices that are used in the human body. In particular, the present disclosure is directed to embodiments of an occlusion device that reduce the risk of peri-device leak. More specifically, the present disclosure is directed to an occlusion device with improved fabric patch placement and securement. The embodiments and methods disclosed herein enable increased occlusion after the occlusion device with the fabric patch has been deployed at the target site.
An occluder is a medical device used to treat (e.g., occlude) tissue at a target site within the human body, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, a lumen, or the like. For example, an occluder may be used in Left Atrial Appendage (LAA) closures. LAAs are common heart defects in which there is a sac in the muscle wall of the left atrium. When a patient experiences atrial fibrillation (AFib), a blood clot may be formed in the LAA which may become dislodged and enter the blood stream. By occluding the LAA, the release of blood clots from the LAA may be significantly reduced, if not eliminated. Various techniques have been developed to occlude the LAA.
In the case of some known medical devices, a lobed portion of the device sits in a body of the LAA, and a disc portion is engaged with an opening of the LAA. In some known medical devices, a fabric patch is coupled only to a proximal surface of the lobe portion to assist with occlusion of blood flow into the body of the LAA and provide a sealing effect when the lobe portion is fully seated within the body of the LAA. However, the lobe portion of the device may become dislodged or disengaged from the LAA, such that part of the lobe portion is positioned outside of the LAA. In such cases, the sealing effect of the fabric patch is reduced, which may lead to peri-device leakage.
In other known medical devices, the fabric patch is incorporated into the disc portion of the device and is coupled only to the proximal surface of the disc portion. When the medical device is deployed at a target site, tension is exerted between the lobe portion and the disc portion, to pull the distal surface of the disc portion towards the lobe portion (e.g., away from the proximal surface of the disc portion). This tension may cause deformation of the disc portion, such that the edges of the fabric patch are pulled away from the LAA opening, which may lead to peri-device leakage.
It would be advantageous to provide an improved occlusion device that reduces the risk of peri-device leakage.
The present disclosure is directed to a medical device. The medical device includes a proximal end and a distal end. The proximal end includes a disc and the distal end includes a lobe. The disc and lobe are connected by a connecting member. The disc includes a proximal surface and a distal surface. The lobe includes a proximal surface, a distal surface, and a side surface extending between and connecting the proximal surface and distal surface of the lobe. The medical device also includes a fabric patch. The fabric patch is coupled to the proximal surface of at least one of the disc or the lobe and to at least one additional surface of the at least one of the disc or the lobe.
The present disclosure is also directed to a delivery system for delivering a medical device to a target site. The delivery system includes a medical device including a proximal end and a distal end. The proximal end includes a disc and the distal end includes a lobe. The disc and lobe are connected by a connecting member. The disc includes a proximal surface and a distal surface. The lobe includes a proximal surface, a distal surface, and a side surface extending between and connecting the proximal surface and distal surface of the lobe. The medical device also includes a fabric patch. The fabric patch is coupled to the proximal surface of at least one of the disc or the lobe and to at least one additional surface of the at least one of the disc or the lobe. The delivery system also includes a delivery device coupled to the medical device, the delivery device including a catheter and a delivery cable, wherein the medical device is coupled to the delivery cable, and wherein the delivery cable is configured to be advanced through the catheter to deploy the medical device at the target site.
The present disclosure is further directed to a method for closing a Left Atrial Appendage (LAA). The method includes providing a medical device including a proximal end and a distal end. The proximal end includes a disc and the distal end includes a lobe. The disc and lobe are connected by a connecting member. The disc includes a proximal surface and a distal surface. The lobe includes a proximal surface, a distal surface, and a side surface extending between and connecting the proximal surface and distal surface of the lobe. The medical device also includes a fabric patch. The fabric patch is coupled to the proximal surface of at least one of the disc or the lobe and to at least one additional surface of the at least one of the disc or the lobe. The method includes advancing the medical device to the LAA using a delivery system including a catheter and a delivery cable, positioning the medical device relative to the LAA to occlude blood flow to and from the LAA, and de-coupling the medical device from the delivery cable to deploy the medical device.
Corresponding reference characters indicate corresponding parts throughout the several views of the drawings. It is understood that that figures are not necessarily to scale.
The present disclosure relates generally to medical devices that are used in the human body. Specifically, the present disclosure provides medical devices, such as occlusion devices, including a distal lobe, a proximal disc, and a fabric patch that extends beyond the proximal surface and is coupled to the lobe and/or the disc.
Accordingly, the occlusion devices of the present disclosure facilitate improved fabric patch configuration, placement, and securement, which enable enhanced sealing between the medical device and patient's vascular system. Therefore, peri-device leakage around the medical device may be reduced or eliminated.
The disclosed embodiments may lead to more consistent and improved patient outcomes. It is contemplated, however, that the described features and methods of the present disclosure as described herein may be incorporated into any number of systems as would be appreciated by one of ordinary skill in the art based on the disclosure herein.
Although the exemplary embodiment of the medical device is described as treating a target site including a left atrial appendage (LAA), it is understood that the use of the term “target site” is not meant to be limiting, as the medical device may be configured to treat any target site, such as an abnormality, a vessel, an organ, an opening, a chamber, a channel, a hole, a cavity, or the like, located anywhere in the body. The term “vascular abnormality,” as used herein is not meant to be limiting, as the medical device may be configured to bridge or otherwise support a variety of vascular abnormalities. For example, the vascular abnormality could be any abnormality that affects the shape of the native lumen, such as an atrial septal defect, an LAA, a lesion, a vessel dissection, or a tumor. Embodiments of the medical device may be useful, for example, for occluding an LAA, patent foreman ovalis (PFO), atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosus (PDA), as noted above. Furthermore, the term “lumen” is also not meant to be limiting, as the vascular abnormality may reside in a variety of locations within the vasculature, such as a vessel, an artery, a vein, a passageway, an organ, a cavity, or the like. As used herein, the term “proximal” refers to a part of the medical device or the delivery device that is closest to the operator, and the term “distal” refers to a part of the medical device or the delivery device that is farther from the operator at any given time as the medical device is being delivered through the delivery device. In addition, the terms “deployed” and “implanted” may be used interchangeably herein.
Some embodiments of the present disclosure provide an improved percutaneous catheter directed intravascular occlusion device for use in the vasculature in patients' bodies, such as blood vessels, channels, lumens, a hole through tissue, cavities, and the like, such as a left atrial appendage. Other physiologic conditions in the body occur where it is also desirous to occlude a vessel or other passageway to prevent blood flow into or therethrough. These device embodiments may be used anywhere in the vasculature where the anatomical conditions are appropriate for the design.
The medical device may include one or more layers of occlusive material, wherein each layer may be comprised of any material that is configured to substantially preclude or occlude the flow of blood so as to facilitate thrombosis. As used herein, “substantially preclude or occlude flow” shall mean, functionally, that blood flow may occur for a short time, but that the body's clotting mechanism or protein or other body deposits on the occlusive material results in occlusion or flow stoppage after this initial period.
The present disclosure now will be described more fully hereinafter with reference to the accompanying drawings, in which some, but not all embodiments of the disclosure are shown. Indeed, this disclosure may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout.
The present disclosure is directed to various embodiments of medical devices including fabric patches that are additions and/or alternatives to conventional fabric patches included in known medical devices, to resolve the above-described potential disadvantages of known medical devices. The fabric patches of the present disclosure may be coupled to the proximal surface of at least one of the disc or the lobe and to at least one additional aspect or surface of the at least one of the disc or the lobe, providing increased coverage of the medical device by the fabric patch and enhanced sealing between the medical device and the patient's vascular system.
Turning now to
In the particular embodiment of
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In the embodiment of
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Medical device 110 as shown in
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Medical device 110 as shown in
Fabric patch 132 may be comprised of any suitable material that allows for fabric patch 132 to provide a sealing effect to medical device 110. Examples of suitable material may include but are not limited to polyester and polyethylene.
In one embodiment, medical device 110 (e.g., disc 116, lobe 118, connecting member 120) is formed from a shape-memory material. One particular shape memory material that may be used is Nitinol. Nitinol alloys are highly elastic and are said to be “superelastic,” or “pseudoelastic.” This elasticity may allow medical device 110 to be resilient and return to a preset, expanded configuration for deployment following passage in a distorted form through delivery catheter 104. Further examples of materials and manufacturing methods for medical devices with shape memory properties are provided in U.S. Publication No. 2007/0265656 titled “Multi-layer Braided Structures for Occluding Vascular Defects” and filed on Jun. 21, 2007, which is incorporated by reference herein in its entirety. In one exemplary embodiment, medical device 110 (e.g., disc 116, lobe 118, connecting member 120) is formed from a braided shaped-memory material (e.g., a braided nitinol fabric or other mesh material, such as PE, PET, Si, PLLA, PLGA, P1A, PLLA-PLC, etc.), to provide an occlusive effect. Moreover, the braided mesh fabric material enables medical device 110 to be selectively transitioned from an expanded configuration to a collapsed configuration for delivery (e.g., through delivery catheter), and return to the expanded configuration upon deployment at the target site.
It is also understood that medical device may be formed from various materials other than Nitinol that have elastic properties, such as stainless steel, trade named alloys such as Elgiloy®, or Hastalloy, Phynox®, MP35N, CoCrMo alloys, metal, polymers, or a mixture of metal(s) and polymer(s). Suitable polymers may include PET (Dacron™), polyester, polypropylene, polyethylene, HDPE, Pebax™, nylon, polyurethane, silicone, PTFE, polyolefins and ePTFE. Additionally, it is contemplated that the medical device may comprise any material that has the desired elastic properties to ensure that the device may be deployed, function as an occluder, and be recaptured in a manner disclosed within this application.
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Method 800 also includes advancing 804 the medical device to the LAA using a delivery system including a catheter and a delivery cable, positioning 806 the medical device relative to the LAA to occlude blood flow to and from the LAA, and de-coupling 808 the medical device from the delivery cable to deploy the medical device.
Method 800 may include additional, alternative, and/or fewer steps, including those described herein. For example, in some embodiments, positioning 806 the medical device relative to the LAA includes placing the lobe of the medical device within the body of the LAA and the disc outside of the LAA to abut the adjacent wall surrounding the opening of the LAA.
Additionally, de-coupling 808 the medical device from the delivery cable includes medical device transitioning from the constricted configuration adopted for delivery from a catheter to the preset expanded configuration.
While embodiments of the present disclosure have been described, it should be understood that various changes, adaptations and modifications may be made therein without departing from the spirit of the disclosure and the scope of the appended claims. Further, all directional references (e.g., upper, lower, upward, downward, left, right, leftward, rightward, top, bottom, above, below, vertical, horizontal, clockwise, and counterclockwise) are only used for identification purposes to aid the reader's understanding of the present disclosure, and do not create limitations, particularly as to the position, orientation, or use of the disclosure. It is intended that all matter contained in the above description or shown in the accompanying drawings shall be interpreted as illustrative only and not limiting. Changes in detail or structure may be made without departing from the spirit of the disclosure as defined in the appended claims.
Many modifications and other embodiments of the disclosure set forth herein will come to mind to one skilled in the art to which this disclosure pertains having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the disclosure is not to be limited to the specific embodiments described and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
Any patent, publication, or other disclosure material, in whole or in part, that is said to be incorporated by reference herein is incorporated herein only to the extent that the incorporated materials does not conflict with existing definitions, statements, or other disclosure material set forth in this disclosure. As such, and to the extent necessary, the disclosure as explicitly set forth herein supersedes any conflicting material incorporated herein by reference. Any material, or portion thereof, that is said to be incorporated by reference herein, but which conflicts with existing definitions, statements, or other disclosure material set forth herein will only be incorporated to the extent that no conflict arises between that incorporated material and the existing disclosure material.
This application claims the benefit of priority to U.S. Prov. Pat. App. No. 63/143,062 filed Jan. 29, 2021, which is incorporated by reference herein in its entirety.
Number | Date | Country | |
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63143062 | Jan 2021 | US |