Devices, systems, and methods for deploying anchors to a predetermined depth in tissue - Patents.com

Abstract

Devices, systems, and methods for delivery and deployment of an implantable device. The implantable device may be an anchor. The device includes an anchor garage configured to deliver the anchor to a target site therein and an atraumatic shield movable relative to the anchor garage. A biasing element biases the atraumatic shield into position relative to the anchor garage. In some embodiments, the distal end of the anchor garage is a sharp, tissue-penetrating end, and the atraumatic shield is biased distally over such sharp end. A limit stop may be provided to limit the extent to which the anchor garage extends distally, thereby limiting the depth of tissue penetration by the anchor garage and deployment of the anchor. An indicator may be positioned and / or configured to provide an indication of the relative positions of the anchor garage and the atraumatic shield.

Description

[Technical Field]

[0001] The present disclosure relates generally to the field of implantable medical devices. Specifically, the present disclosure relates to devices, systems, and methods for implanting devices, such as anchor devices, into tissue. Even more specifically, the present disclosure relates to devices, systems, and methods for delivering and deploying devices, such as anchors, into tissue to a predetermined implantation depth. [Background technology]

[0002] Various medical procedures involve anchoring devices or systems to tissue. For example, cardiac repair procedures involving repair of heart valve leaflets involve anchoring chordae tendineae, which extend at one end from the heart valve leaflets to cardiac tissue. More specifically, artificial chordae tendineae may be attached from the heart valve leaflets to cardiac tissue, such as papillary muscle tissue, or to the heart wall. A common technical challenge associated with such procedures is the potential for anchor detachment, which can sometimes occur shortly after delivery. One suspected cause of such anchor detachment is myocardial necrosis. A need remains for fixation of devices relative to the implantation site in a manner that resists detachment of the device from the implantation site. Summary of the Invention

[0003] This Summary is provided to introduce a selection of concepts in a simplified form that are further described below in the Detailed Description. This summary is not intended to necessarily identify key features or essential features of the claimed subject matter, nor is it intended as an aid in determining the scope of the claimed subject matter. Those skilled in the art will appreciate that each of the various aspects and features of the present disclosure, whether or not described in this Summary, can be used advantageously in some instances separately, or in other instances in combination with other aspects and features of the present disclosure. No limitation on the scope of the claimed subject matter is intended by either the inclusion or non-inclusion of any element, component, etc. in this Summary.

[0004] In accordance with various principles of the present disclosure, an anchor delivery and deployment device includes an anchor garage configured to deliver an anchor therein, an atraumatic shield movable relative to the anchor garage, and a biasing element configured to bias the atraumatic shield into position relative to the anchor garage.

[0005] Optionally, the anchor delivery and deployment device includes an indicator of the relative position of the anchor garage and the atraumatic shield. In some embodiments, the indicator is a visual indicator. In some embodiments, the indicator includes at least one radiopaque marker. In some embodiments, the indicator generates a signal indicative of the relative position of the anchor garage and the atraumatic shield. In some embodiments, the indicator indicates when the anchor delivery and deployment device has contacted tissue.

[0006] Additionally or optionally, the anchor delivery and deployment device includes a limit stop positioned to limit relative movement between the anchor garage and the atraumatic shield, hi some embodiments, the limit stop is positioned and configured to limit proximal retraction of the atraumatic shield relative to the anchor garage.

[0007] In some embodiments, the distal end of the anchor garage is sharpened to penetrate tissue, and a biasing element biases the atraumatic shield onto the distal end of the anchor garage, hi some embodiments, a limit stop is positioned to control advancement of the sharp distal end of the anchor garage from the atraumatic shield.

[0008] In some embodiments, the biasing element includes a plurality of elongated beams proximal to the atraumatic shield, the plurality of elongated beams being biased into an elongated configuration along the anchor garage to bias the atraumatic shield distal to the anchor garage. In some embodiments, the beams are formed from a wall of the anchor garage.

[0009] In accordance with various principles of the present disclosure, an anchor delivery and deployment system includes an anchor, an anchor garage configured to deliver the anchor therein, an atraumatic shield movable relative to the anchor garage, and a biasing element configured to bias the atraumatic shield into position relative to the anchor garage.

[0010] Optionally, the anchor delivery and deployment system includes a tubular delivery element configured to transluminally deliver the anchor, anchor garage, and atraumatic shield through the patient's body to the target site.

[0011] Optionally, the anchor delivery and deployment system includes an indicator configured to indicate the relative position of the anchor garage and the atraumatic shield. Optionally, the anchor delivery and deployment system includes a limit stop positioned to limit relative movement of the atraumatic shield with respect to the anchor garage.

[0012] In accordance with various principles of the present disclosure, a method of delivering and deploying an anchor to a target site within a patient's body includes delivering an anchor within an anchor garage to the target site, contacting an atraumatic shield positioned relative to the anchor garage with tissue at the target site to retract the atraumatic shield proximally relative to the anchor garage, deploying the anchor at the target site, retracting the anchor garage proximally from the target site to enable a biasing element to bias the atraumatic shield distally relative to the anchor garage, and retracting the anchor garage and the atraumatic shield from the target site.

[0013] The method optionally further includes causing indicators positioned relative to the atraumatic shield and the anchor garage to indicate the relative positions of the atraumatic shield and the anchor garage.

[0014] The method optionally further includes advancing the anchor garage and the atraumatic shield distally relative to the tissue, such that the atraumatic shield is retracted proximally relative to the anchor garage until the atraumatic shield encounters a limit stop preventing further proximal movement.

[0015] The method optionally further includes allowing the biasing element to bias the atraumatic shield distally against the anchor garage, the biasing element returning the biasing element to a configuration in which the anchor garage, the atraumatic shield, and the biasing element can be retracted within the delivery device for withdrawal from the patient.

[0016] These and other features and advantages of the present disclosure will become readily apparent from the following detailed description, and the scope of the claimed invention is set forth in the appended claims. Although the following disclosure is presented in terms of aspects or embodiments, it should be understood that each aspect may be claimed separately or in combination with aspects and features of that embodiment or any other embodiment. [Brief explanation of the drawings]

[0017] Non-limiting embodiments of the present disclosure are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The accompanying drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the drawing figures may vary. For example, it is contemplated that a device may be enlarged so that details are discernible, but may also be reduced in size to fit within the working channel of, for example, a delivery catheter or endoscope. In the figures, identical, nearly identical, or equivalent elements are typically labeled with the same reference numerals, and similar elements are typically labeled with similar reference numerals that differ in increments of 100, and redundant description is omitted. For clarity and conciseness, not every element is labeled in every figure, nor is every element of each embodiment shown unless an example is necessary to enable those skilled in the art to understand the disclosure.

[0018] The detailed description will be better understood in conjunction with the accompanying drawings, in which like reference numerals represent like elements, as follows: FIG. 1 is a perspective view of an example anchor delivery and deployment device and system formed in accordance with various principles of the present disclosure shown in a schematic illustration of a heart for deployment in cardiac tissue.

[0019] FIG. 2 is a perspective view of the anchor delivery and deployment device and system shown in FIG. 1, with the anchor delivery and deployment device shown in a delivery configuration. FIG. 3 is a perspective view similar to FIG. 2, but with the anchor delivery and deployment device in a deployed configuration.

[0020] FIG. 4A is an elevational view of the anchor delivery and deployment device shown in FIG. 1, etc., delivering the anchor device to a tissue wall. FIG. 4B shows an elevational view similar to FIG. 4A, but after the anchoring device has been deployed and the anchoring device and deployment device have been withdrawn from the tissue wall.

[0021] FIG. 5 is a perspective view of another example anchor delivery and deployment device and system formed in accordance with various principles of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0022] The following detailed description should be read with reference to the drawings illustrating exemplary embodiments. It will be understood that the present disclosure is not limited to the particular embodiments described, as such may vary. All devices, systems, and methods discussed herein are examples of devices and / or systems and / or methods implemented in accordance with one or more principles of the present disclosure. Each example embodiment is provided for illustrative purposes and is merely an example, not the only way, to implement these principles. Thus, references to elements, structures, or features in the drawings should be properly recognized as references to example embodiments of the present disclosure and should not be understood as limiting to the particular element, structure, or feature shown. Other examples of ways to implement the disclosed principles will occur to those skilled in the art upon reading this disclosure. Indeed, it will be apparent to those skilled in the art that various modifications and variations can be made in the present disclosure without departing from the scope or spirit of the present subject matter. For example, features illustrated or described as part of one embodiment can be used with other embodiments to yield yet another embodiment. Accordingly, the present subject matter is intended to cover modifications and variations within the scope of the appended claims and their equivalents.

[0023] It will be understood that the present disclosure is described in various levels of detail herein. In some instances, details that are not necessary for those skilled in the art to understand the present disclosure or that would make other details difficult to perceive may be omitted. The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting beyond the scope of the appended claims. Unless otherwise defined, technical terms used herein should be understood as commonly understood by one of ordinary skill in the art to which the present disclosure belongs. All of the devices and / or methods disclosed and claimed herein can be made and executed without undue experimentation in light of the present disclosure.

[0024] As used herein, "proximal" refers to a direction or location closest to a user (e.g., a medical professional or practitioner or clinician or technician or operator or physician, such terms are used interchangeably herein without limitation and include an automated controller system or other method) when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery) and / or when closest to a delivery device, and "distal" refers to a direction or location furthest from a user when using the device (e.g., when introducing the device into a patient or during implantation, positioning, or delivery) and / or when closest to a delivery device. "Longitudinal" means extending along the longer or greater dimension of an element. A "longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight or does not necessarily maintain a fixed configuration when the element bends or flexes, and "axial" refers generally along the longitudinal axis. However, it will be understood that references to axial or longitudinal movement with respect to the above-described systems or their elements need not be strictly limited to axial and / or longitudinal movement along the longitudinal or central axis of the referenced elements. "Center" means at least approximately bisecting the center point and / or being approximately equidistant from the periphery or boundary, and "central axis," with respect to an opening, means a line at least approximately bisecting the center point of the opening and extending longitudinally along the length of the opening when the opening comprises, for example, a tubular element, channel, cavity, or bore. As used herein, "lumen" or "channel" or "bore" or "passage" is not limited to a circular cross-section. As used herein, the "free end" of an element is the terminus beyond which such element does not extend. It will be understood that terms such as "at," "on," "adjacent to," or "along" may be used interchangeably herein without limitation, unless otherwise specified, and are intended to generally indicate relative spatial relationships, rather than precisely defined locations. Finally, reference to "at" a location or region is intended to include at and / or around (e.g., along, adjacent, etc.) such location or region.

[0025] In accordance with various principles of the present disclosure, an implantable device, such as an anchor device, is deployed deep enough within tissue so as to be firmly anchored thereto and resist dislodging therefrom. The term anchor is used for convenience and may be used interchangeably herein with terms such as anchor component, anchor device, anchor element, anchor mechanism, anchor component, anchor device, anchor element, anchor mechanism, etc., it being understood that such terms are known in the art to refer to structures configured to hold other objects in place. For convenience, and without any intention of limitation, it will be referred to herein simply as an anchor. It will be understood that references to anchors herein, including in the appended claims, are for convenience and may encompass other implanted medical devices unless expressly indicated otherwise. It will further be understood that terms such as implant (and other grammatical forms) may be used interchangeably herein with terms (and grammatical forms thereof) such as affix, anchor, attach, associate, couple, engage, embed, hold, maintain, grasp, secure, etc., without any intention of limitation.

[0026] To control the depth to which the anchor is deployed (e.g., to ensure sufficient grip with the tissue and, optionally, to limit excessive depth of insertion so that the device does not completely penetrate the tissue wall to be anchored), the anchor delivery and deployment device is configured to facilitate deployment of the anchor to a predetermined depth. The delivery device may be configured in accordance with various principles of the present disclosure to puncture at a predetermined depth before deploying the anchor. The device may further be configured to indicate that a specified insertion depth has been achieved and that the anchor may then be deployed. For example, it may be desirable to insert the anchor deep into tissue where necrosis is less likely to occur. Furthermore, the fixation features on the anchor may be optimized to obtain a retention force that is independent of insertion depth. For example, the width, thickness, number, spread, etc. of the anchor's claws may be adjusted to achieve a desired retention force against the tissue.

[0027] More specifically, according to various principles of the present disclosure, an anchor delivery and deployment device includes an anchor garage having an internal lumen into which the anchor is delivered and from which the anchor is deployed. The anchor garage, as referred to herein, is typically a tubular element having a lumen sized, shaped, configured, and / or dimensioned to accommodate the anchor therein, thereby allowing the anchor garage, along with the anchor therein, to be delivered to a target site within a patient's body. The distal end of the anchor garage may have a sharp needle tip (e.g., configured to penetrate tissue) or may be blunt. Further, according to various principles of the present disclosure, an atraumatic shield is movably attached to the anchor garage to indicate and / or control the depth of insertion of the anchor into tissue. The shield may be spring-loaded to extend over the distal end of the anchor garage. However, when the anchor delivery and deployment device engages tissue at the deployment site, the atraumatic shield retracts proximally relative to the distal end of the anchor garage (e.g., against a spring biasing force). If the distal end of the anchor garage is sharp, the atraumatic shield may retract to shield the sharp end of the anchor garage before allowing the anchor garage to be advanced into tissue at the anchor deployment site. The anchor delivery and deployment device may include a limit stop for the atraumatic shield. When the atraumatic shield reaches the limit stop, the anchor garage is properly positioned to achieve the desired deployment of the anchor. For example, the limit stop functions to limit the extent to which the distal end of the anchor garage can extend beyond the atraumatic shield into tissue. The anchor delivery and deployment device may include any of a variety of indicators that allow the medical professional deploying the anchor to determine that tissue has been engaged by the anchor delivery and deployment device and / or that the desired insertion depth has been achieved. For example, the limit stop may serve as an indicator to provide confidence that the anchor is properly deployed within the tissue, such as that the distal end of the anchor garage has sufficiently engaged the tissue to achieve full deployment of the anchor at a desired depth within the tissue.Other indicators may be positioned and / or configured to provide an indication of the relative position of the anchor garage and the atraumatic shield. Additionally or alternatively, the indicator may generate a signal indicative of the relative position of the anchor garage and the atraumatic shield. If the distal end of the anchor garage is relatively blunt and not configured to penetrate tissue at the target site, an indication that the anchor delivery and deployment device has engaged tissue, such as to a desired extent, may allow a medical professional to deploy the anchor from the anchor garage once adequate tissue contact is achieved, thereby enhancing deployment of the anchor within the tissue (e.g., ensuring solid fixation of the anchor with the tissue). As will be appreciated, anchor delivery, deployment, and engagement may be facilitated by use of known medical visualization techniques, such as fluoroscopy, ultrasound, intracardiac ultrasound, etc. The indicator may be configured to be imaged or otherwise sensed using such techniques or other techniques known to those skilled in the art, and the present disclosure is not limited in this respect.

[0028] Example embodiments of the devices described herein provide for, but are not limited to, fixation of various devices, systems, or tools to anatomical structures, such as the heart. One example of a procedure that may utilize the devices, systems, and methods of the present disclosure is the treatment of heart disease. More specifically, the devices, systems, and methods described herein may be used in conjunction with devices or systems for repositioning, repairing, and / or replacing one or more of a valve's leaflets and / or chordae tendineae to treat heart disease. The repositioning, repairing, and / or replacing one or more of a valve's leaflets and / or chordae tendineae may include one or more devices secured to one or more heart valve leaflets and cardiac tissue, such as papillary muscle tissue. Leaflet clips may be attached to the heart valve leaflets, and artificial chordae tendineae may extend from the leaflet clips and be secured to the heart, such as cardiac tissue, such as papillary muscle tissue, using anchors.

[0029] The anchor may include a plurality of tissue-engaging claws configured to pierce the tissue to which the anchor is to be secured. According to various principles of the present disclosure, the anchor is delivered in a delivery configuration within an anchor garage provided with an atraumatic shield as described above. The delivery configuration may be a compact, or compressed, configuration. The anchor is moved out of the anchor garage and shifted to a deployed configuration. The deployed configuration may be an open, or expanded, configuration having an outer dimension larger than the outer dimension of the anchor when in the delivery configuration and larger than the inner diameter of the anchor garage.

[0030] The anchor's claws can be biased to a delivery configuration (and held in place within the delivery configuration) and delivered to a deployment site within the anchor garage. The claws can be biased to extend to a deployed configuration, such as a curved or arcuate configuration, when extending from the anchor garage to secure against tissue at the deployment site. For example, the claws can be biased to extend to a deployed, expanded configuration, with the claws' neutral configuration being the claws' neutral configuration. The anchor garage can constrain or hold the anchor's claws in a compact configuration to fit within the anchor garage's inner diameter. In some embodiments, the anchor's claws are extended or extended in the compact configuration to extend along the longitudinal axis of the anchor garage. An actuator, such as a pusher rod, can be used to move the anchor from the anchor garage and deploy it into body tissue. When the anchor is no longer within the anchor delivery and deployment device, the anchor's claws can move to an open configuration, such as an expanded configuration. When the claws are spring-biased into the deployed configuration, it is important that the distal tips of the claws be advanced into the tissue so that the claws expand while in the tissue at the deployment site, rather than expanding outside of the tissue. The distal ends of the anchor claws may be configured to pierce and penetrate the tissue and expand into the deployed configuration to become anchored within the body tissue.

[0031] Examples of devices, systems, and methods in which embodiments of the present disclosure may be implemented include, but are not limited to, U.S. Patent Application Publication No. US2021 / 0000597, published January 7, 2021, entitled "Devices, Systems, and Methods For Adjustably Tensioning An Artificial Chordae Tendinae Between a Leaflet and Papillary Muscle or Heart Wall," U.S. Patent Application Publication No. US2021 / 0000598, published January 7, 2021, entitled "Devices, Systems, and Methods For Anchoring An Artificial Chordae Tendinae To A Papillary Muscle or Heart Wall," and U.S. Patent Application Publication No. US2021 / 0000599, published March 31, 2022, entitled "Devices, Systems, and Methods For Adjustably Tensioning Artificial Chordae Tendinae Intracardiac." and US Patent Application Publication No. US2023 / 0123832, entitled "Devices, Systems, and Methods for Clamping an Artificial Chordae Tendinae To Cardiac Tissue," published on March 2, 2023, each of which is incorporated herein by reference in its entirety for all purposes.The device examples described therein may be modified to incorporate one or more embodiments or features of the present disclosure.

[0032] Example embodiments of the devices described herein may provide fixation for other devices, systems, or tools to an anatomical structure, such as the heart. It will be understood that the devices and systems described herein may be used in conjunction with the devices or systems disclosed in the above-referenced applications incorporated herein, or may be used in conjunction with other devices and systems, such as those described herein.

[0033] While the accompanying drawings illustrate ventricular and mitral valve repair, it will be understood that the principles of the present disclosure are applicable to other cardiac structures, including, but not limited to, the tricuspid valve. Additionally, while the present disclosure illustrates repair of valve leaflets and fixation of artificial chordae to papillary muscles, the principles of the present disclosure are applicable to devices other than the anchors shown, procedures other than valve leaflet repair (whether or not related to fixation of artificial chordae to cardiac tissue), and non-cardiac procedures.

[0034] Various embodiments of devices, systems, and methods for delivering and deploying implantable devices, such as anchors, are described with reference to examples shown in the accompanying drawings. References herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more particular features, structures, concepts, and / or characteristics in accordance with the principles of the present disclosure may be included in connection with an embodiment. However, such references do not necessarily imply that all embodiments include the particular feature, structure, concept, and / or characteristic, or that an embodiment includes all features, structures, concepts, and / or characteristics. Some embodiments may include one or more such features, structures, concepts, and / or characteristics in various combinations thereof. It should be understood that one or more of the features, structures, concepts, and / or characteristics described with reference to one embodiment may be combined with one or more of the features, structures, concepts, and / or characteristics of any other embodiment provided herein. That is, any features, structures, concepts, and characteristics described herein may be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present disclosure. Furthermore, references in various places herein to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., do not necessarily all refer to the same embodiment, and separate or alternative embodiments do not necessarily mutually exclude other embodiments. Furthermore, it is to be understood that various features, structures, concepts, and / or properties of the disclosed embodiments are independent and distinct from one another and can be used or exist individually or in various combinations with one another to create alternative embodiments that are considered part of this disclosure. Accordingly, the present disclosure is not limited to only the embodiments specifically described herein, as it would be prohibitively cumbersome to describe all of the many possible combinations and subcombinations of features, structures, concepts, and / or properties. Furthermore, the example embodiments disclosed herein are not intended to limit the broader aspects of the present disclosure.It should be understood that the various dimensions provided herein are examples, and that one of ordinary skill in the art can readily determine appropriate ranges of standard deviation and acceptable variation therefrom that are encompassed by the present disclosure and any claims associated therewith. The following description is merely illustrative of embodiments and is not intended as limiting the broader aspects of the present disclosure.

[0035] It will be understood that common features are identified by common reference elements, and for brevity and convenience, without intending to be limiting, descriptions of common features generally will not be repeated. For clarity, not all components having the same reference number are numbered. Furthermore, groups of similar elements may be indicated by numbers and letters, and reference may generally be made to such elements as one or a group by the number alone (without including the letter associated with each similar element). In the following description, it will be understood that similar elements or components among various illustrated embodiments having reference numbers greater than 100 will generally be designated by the same reference number incremented by a multiple of 100, and redundant descriptions will generally be omitted for brevity. Furthermore, specific features in one embodiment may be used across different embodiments and will not necessarily be individually labeled when appearing in different embodiments.

[0036] Referring to the drawings, an anchor delivery and deployment system 100 formed in accordance with various principles of the present disclosure is shown in FIG. 1 and positioned to deploy an anchor within a cardiac wall. Anchor delivery and deployment system 100 includes anchor delivery and deployment device 110 and anchor 120. Anchor delivery and deployment device 110 includes anchor garage 130 configured for delivery and deployment of anchor 120. Anchor garage 130 may alternatively be referred to herein, without limitation, as a delivery housing, sheath, or the like. Anchor 120 is delivered within anchor garage 130 in a generally unexpanded delivery configuration, as can be understood with reference to FIGS. 2 and 3. In the example embodiment shown in FIG. 2, anchor garage 130 has a sharp distal tip 131 configured to penetrate tissue at target site TS and facilitate deployment of anchor 120, as will be described in further detail below with reference to FIGS. 4A and 4B. Alternatively, the distal tip of the anchor garage may be blunt, as illustrated in FIG. 5, as described in more detail below.

[0037] In accordance with various principles of the present disclosure, atraumatic shield 140 is movably positioned relative to distal tip 131 of anchor garage 130. Atraumatic shield 140 is configured to move proximally relative to anchor garage 130, such as upon contact with tissue at target site TS. In some embodiments, atraumatic shield 140 covers distal tip 131 of anchor garage 130 during delivery and is retractable proximally to expose distal tip 131 of anchor garage 130, such as when anchor 120 is deployed from anchor garage 130. Movement of atraumatic shield 140 may provide confirmation of contact between anchor delivery and deployment device 110 and tissue, and / or may ensure engagement of anchor 120 with tissue to ensure full and complete deployment of anchor 120 (e.g., confirming / ensuring that all claws of anchor 120 are deployed within tissue), and / or may ensure a desired depth of penetration and deployment of anchor 120, and may provide various other benefits as described in further detail below.

[0038] The atraumatic shield 140 may be biased distally toward the distal end 131 of the anchor garage 130 by a biasing element 150. The biasing element 150 holds the atraumatic shield 140 in a distal position adjacent to (e.g., over) the distal end 131 of the anchor garage 130, as shown in FIGS. 1 and 2. The biasing element 150 may move (e.g., contract, bend, bow, or otherwise change configuration) to enable proximal retraction of the atraumatic shield 140 relative to the anchor garage 130, as shown in FIG. 3. For example, the biasing element 150 may enable retraction of the atraumatic shield 140 by applying a force to the distal end 141 of the atraumatic shield 140 and / or by the distal end 141 of the atraumatic shield 140 encountering another object, such as a tissue wall (e.g., at the target site TS). Biasing element 150 may be configured to return atraumatic shield 140 to a distal position when a force or obstruction against atraumatic shield 140 is removed. For example, in some instances, it may be desirable to retract anchor delivery and deployment device 110 into tubing element 160 through which anchor delivery and deployment device 110 can be delivered transluminally within a patient to a target site TS (as shown in FIG. 1 ). Tubing element 160 may be a delivery shaft or other device, such as leaflet clip delivery device 162 as shown in FIG. 1 (which delivers and deploys leaflet clips 164 onto the cardiac valve leaflets with artificial chordae tendineae 166 extending from leaflet clip 164 to anchors 120 within anchor garage 130). In such cases, it may be desirable for biasing element 150 to return to a configuration that allows anchor delivery and deployment device 110 to be retracted into a tubing element, such as one or more tubing elements that anchor delivery and deployment device 110 was delivered to the target site TS.

[0039] In the example embodiment shown in FIG. 2 , biasing element 150 includes one or more resilient beams 152. Beam 152 holds atraumatic shield 140 in a distal position adjacent to (e.g., over) distal end 131 of anchor garage 130, as shown in FIGS. 1 and 2 . Distal end 151 of beam 152 engages or contacts atraumatic shield 140, and proximal end 153 of beam 152 engages or contacts anchor garage 130. For example, distal end 151 and / or proximal end 153 may be coupled and / or secured to atraumatic shield 140 and anchor garage 130, respectively. It will be understood that terms such as engage, contact, coupled, secured, and other grammatical forms thereof may be used interchangeably herein without any limitation unless expressly indicated. In some embodiments, beam 152 is formed integrally with anchor garage 130, such as by being cut (e.g., laser cut) from the wall of anchor garage 130. Distal end 151 of beam 152 may be separate from anchor garage 130 and attached to atraumatic shield 140 (in any desired manner known to those skilled in the art, such as by welding, soldering, brazing, or a mechanical connection such as an interference fit). In some embodiments, beam 152 is formed separately from anchor garage 130 and optionally fitted onto the wall of anchor garage 130 or into a notch in the wall of anchor garage 130. Distal end 151 of beam may be attached to atraumatic shield 140 in the manner described above. Proximal end 153 may be attached to anchor garage 130 in a manner similar to how proximal end 153 is attached to atraumatic shield 140. Alternatively, ends 151, 153 may be held to anchor garage 130 and / or atraumatic shield 140 by a friction fit or interference fit or other mechanical connection as known to those skilled in the art.

[0040] 2 and 3 may flex, bend, or bow to permit proximal retraction of the atraumatic shield 140 relative to the anchor garage 130, as shown in FIG. 3. For example, application of a force to the distal end 141 of the atraumatic shield 140 and / or the distal end 141 of the atraumatic shield 140 encountering another object, such as a tissue wall (e.g., at the target site TS), may cause the beam 152 to flex, bend, bow, etc., permitting retraction of the atraumatic shield 140. It will be understood that terms such as flex, bend, bow, contract, deform, deflect, etc., including other grammatical forms, may be used interchangeably herein without limitation. The beams 152 may be formed from a shape memory material (e.g., without limitation, a titanium alloy such as Nitinol, or stainless steel, etc.) to bias the beams 152 into a selected configuration. For example, the shape memory of the beams 152 may return the beams 152 to a neutral, resting position, such as the generally extended position shown in FIG. 1, when a force or obstruction on the atraumatic shield 140 is removed. The beams 152 may be configured to return the atraumatic shield 140 to a distal position when a force or obstruction on the atraumatic shield 140 is removed. The shape memory of the beams 152 may hold the atraumatic shield 140 in a distal position that is the same as or close to its initial delivery position (before being retracted proximally). In instances where anchor delivery and deployment device 110 is retracted within a tubular element (such as shaft 160 through which anchor delivery and deployment device 110 was delivered) upon deployment of anchor 120, biasing element 150 may return beam 152 to (or near) the initial delivery position prior to deployment of anchor 120 so that it fits back within the tubular delivery element. It will be appreciated that the flexibility of beam 152 may be adjusted or otherwise tailored to suit a particular use, environment, etc. of biasing element 150, such as to adjust or achieve a desired degree of retraction of atraumatic shield 140.

[0041] In accordance with various principles of the present invention, as described above, the distal end 141 of the atraumatic shield 140 may be blunt, curved, rounded, or otherwise configured to provide an atraumatic surface for contacting tissue in an atraumatic material. The blunt distal end 141 of the atraumatic shield 140 may be sized, shaped, configured, and dimensioned to facilitate pressing the atraumatic shield 140 against cardiac tissue without pressing the distal end 141 of the atraumatic shield 140 into the cardiac tissue. For example, the distal end 141 of the atraumatic shield 140 may be inwardly rounded or curved (to present a convexly curved outer surface), or otherwise formed to be sufficiently blunt so as not to injure the tissue against which the atraumatic shield 140 is pressed. For example, without limitation, the edge of distal end 141 of atraumatic shield 140 may be curved with a radius of approximately 0.0275 inches (0.6985 mm). Pressing distal end 141 of atraumatic shield 140 against tissue may cause atraumatic shield 140 to retract proximally (e.g., when distal end 131 of anchor garage 130 is proximal to distal end 141 of atraumatic shield 140). Such retraction may provide a medical professional with an indication of one or more conditions of interest to the medical professional. For example, proximal retraction of atraumatic shield 140 may be used to indicate the position of anchor delivery and deployment device 110 and / or to control and / or limit the advancement of anchor garage 130 and / or anchor 120 into tissue, as described with reference to the example embodiment shown in FIGS. 4A and 4B and the example embodiment shown in FIG. 5.

[0042] 4A and 4B, anchor delivery and deployment device 110, such as that illustrated in FIGS. 2 and 3, is advanced until it contacts tissue wall TW at target site TS. As anchor delivery and deployment device 110 is advanced distally, blunt distal end 141 of atraumatic shield 140 does not advance distally but instead is retracted proximally relative to anchor garage 130 and against the biasing force of biasing element 150. Anchor delivery and deployment device 110 includes one or more indicators configured to provide information regarding atraumatic shield 140 and / or anchor garage 130 and / or their relative positions to the medical professional operating anchor delivery and deployment system 100. Such information is useful for determining when anchor delivery and deployment device 110 has contacted tissue at target site TS so that anchor 120 can be reliably deployed within tissue at target site TS.

[0043] In some embodiments, at least a portion of atraumatic shield 140 and / or anchor garage 130 is formed of a material that is imageable with any of a variety of imaging systems, such as fluoroscopy and / or ultrasound and / or intracardiac echocardiography, so that a medical professional operating anchor delivery and deployment system 100 can see atraumatic shield 140 as it is retracted proximally. Such a material can function as an indicator. In some embodiments, the indicator is a limited extent of atraumatic shield 140 and / or anchor garage 130 configured to allow a medical professional to see at least the movement of atraumatic shield 140 and optionally also the relative position of atraumatic shield 140 and anchor garage 130. In some embodiments, atraumatic shield 140 includes indicators 142 in the form of one or more visualization markers, such as radiopaque markers, bands, or radiopaque filler material, and anchor garage 130 includes corresponding, typically similarly formed, indicators 132a, 132b. In some embodiments, visualization markers may be provided only on anchor garage 130 such that atraumatic shield 140 covers or masks the visualization markers on anchor garage 130 as atraumatic shield 140 moves proximally. A medical professional may then be able to determine the position of atraumatic shield 140 relative to anchor garage 130 when all visualization markers are masked, when a certain number of visualization markers (e.g., 2 / 3 of the markers) are masked, etc. The position of indicators 142 on atraumatic shield 140 relative to indicators 132 a, 132 b on anchor garage 130 can be viewed using any of a variety of suitable imaging systems to provide a medical professional with information regarding the position, configuration, status, etc. of anchor delivery and deployment device 110 relative to target site TS, etc. The relative positions of anchor garage 130 and atraumatic shield 140 can help indicate that distal end 131 of anchor garage 130 is engaged with tissue to ensure the desired deployment of anchor 120 housed therein.The relative positions of anchor garage 130 and atraumatic shield 140 can indicate that sufficient insertion force / depth of anchor 120 exists, even in a blunt system (e.g., when distal end 131 of anchor garage 130 is blunt, as described in further detail below). For example, sufficient force can be achieved when the entire distal end 131 of anchor garage 130 is in contact with the tissue wall. Optionally, indicators can be provided on anchor garage 130 and / or atraumatic shield 140 that emit a signal (audio, visual, etc.) when atraumatic shield 140 has been retracted distally a selected distance. Such indicators can be activated when elements of atraumatic shield 140 and anchor garage 130 come into contact, in a manner known to those skilled in the art. For example, electrical sensors can be provided on atraumatic shield 140 and anchor garage 130 to generate a signal (audio or visual, such as illuminating an LED) when atraumatic shield 140 is fully retracted.

[0044] Information from the indicator regarding the relative position of the atraumatic shield and the anchor garage extending through the atraumatic shield can be useful to a physician in identifying when anchor delivery and deployment device 110 has contacted tissue and can identify when the device can be deployed (e.g., implanted into such tissue). For example, when anchor delivery and deployment device 110 as shown in FIGS. 4A and 4B contacts tissue wall TW, anchor 120 of anchor delivery and deployment device 110 can be advanced distally into tissue wall TW, as shown in FIG. 4A. In embodiments in which anchor garage 130 has a sharp distal end 131, distal end 131 of anchor garage 130 can also be advanced distally into target site TS to facilitate deployment of anchor 120, as shown in FIG. 4A and discussed in more detail below. However, in the example embodiment of anchor delivery and deployment device 210 shown in FIG. 5, distal end 231 of anchor garage 230 is generally blunt and not configured to penetrate tissue. 5, distal end 241 of atraumatic shield 240 (shown in perspective so that the relative position of anchor garage 230 therein can be seen) extends distally relative to distal end 231 of anchor garage 230. Thus, when atraumatic shield 240 contacts a tissue wall (e.g., tissue wall TW as shown in FIGS. 4A and 4B) and distal advancement of anchor delivery and deployment device 210 continues, atraumatic shield 240 can be retracted or pushed proximally relative to anchor garage 230 through which it extends (e.g., over). Proximal movement of the atraumatic shield 240 relative to the anchor garage 230 may continue until the blunt distal end 231 of the anchor garage 230 (which is initially proximal to the distal end 241 of the atraumatic shield 240 and therefore not in contact with the tissue wall) also contacts the tissue wall, at which point the effect of such contact on the atraumatic shield 240 is minimized, if not eliminated. When such a position is achieved, the physician may receive a tactile indication (e.g., resistance to further advancement of the anchor delivery and deployment device 210).Additionally or alternatively, any of the various indicators may be used, such as those described above for anchor delivery and deployment device 110 illustrated in Figures 2, 3, 4A, and 4B. For example, indicators that can be imaged by any of a variety of imaging systems may be provided on atraumatic shield 240 and / or anchor garage 230, such that the relative motion between atraumatic shield 240 and anchor garage 230 can be observed, including whether the desired relative motion has been achieved (e.g., indicating sufficient contact with tissue for proper, complete, and total deployment of anchor 220).

[0045] In some embodiments, a limit stop 170 may be provided to limit proximal retraction of atraumatic shield 140. Limit stop 170 may be yet another indicator that anchor garage 130 is fully expanded and / or in full contact with tissue so that anchor 120 may be deployed to a desired depth within tissue. As mentioned above, in some embodiments, such as those shown in FIGS. 4A and 4B , anchor garage 130 of anchor delivery and deployment device 110 may have a sharp distal end 131 that may be sharp enough to penetrate tissue wall TW when atraumatic shield 140 is retracted proximally enough to expose a sufficient extent of such sharp distal end 131. In such embodiments, in addition to being an indicator that allows a physician to judge or observe the relative positions of atraumatic shield 140 and anchor garage 130 and determine the appropriate position of anchor garage 130 for deployment of anchor 120, limit stop 170 may limit the depth to which sharp distal end 131 of anchor garage 130 may penetrate tissue wall TW. Limit stop 170 may be a protrusion (e.g., a detent or a weld) as shown in FIG. 4A. Additionally or alternatively, the limit stop may be formed from a portion of the anchor garage, such as from a stamped tab limit stop 270 as shown in FIG. 5. As can be appreciated, limit stops 170, 270 may provide various advantages regardless of whether the distal end of the anchor garage is sharp or blunt.

[0046] Once the anchor 120, 220 is deployed from the anchor garage 130, 230, the biasing element 150, 250 may bias the atraumatic shield 140, 240 distally to cover the distal end 131, 231 of the anchor garage 130, 230 and / or facilitate withdrawal of the anchor delivery and deployment device 110, 220 into the delivery shaft (e.g., the delivery shaft through which the anchor delivery and deployment device 110, 220 was delivered), e.g., to facilitate withdrawal from the patient. For example, as shown in FIG. 4B , once the anchor 120 is deployed within the tissue wall TW, the biasing element 150 may return the atraumatic shield 140 to a position covering the sharp distal end 131 of the anchor garage 130, e.g., to protect tissue from inadvertent contact with the sharp distal end 131.

[0047] It will be understood that other features of anchor delivery and deployment system 100, including anchor delivery and deployment device 210 shown in Figure 5, may be substantially similar to those shown in Figures 1-3, 4A, and 4B, and for brevity, reference may be made to the diagrams and associated descriptions of elements and features shown in those figures. For example, various features of anchor delivery and deployment devices 110, 220 described above may be arranged and operate in substantially the same or similar manner. Thus, for brevity and convenience, and without any intention of limitation, common elements having common functionality will be designated with the same reference character, differing by 100, and reference will be made to the above description of similar elements and operation.

[0048] It will be understood that all devices and methods described herein are examples of devices and / or methods implemented in accordance with one or more principles of the present disclosure. These examples are not the only ways to implement these principles, but are merely examples and are not intended as limitations on the broader aspects of the present disclosure. Accordingly, references to elements or structures or features in the drawings should be understood as references to example embodiments of the present disclosure and should not be understood as limiting the disclosure to the particular elements, structures, or features shown. Other examples of ways of implementing the disclosed principles will occur to those skilled in the art upon reading this disclosure.

[0049] It will be further understood that any or all of the delivery and deployment aspects described above may be performed using any suitable imaging technology available as known or previously known to those skilled in the art.

[0050] As noted above, although embodiments of the present disclosure may be described with specific reference to medical devices, systems, and procedures for deploying (e.g., securing) devices to tissue of the cardiovascular system (e.g., cardiac tissue), it will be understood that such medical devices and methods may be used to treat tissue of the gastrointestinal system, the abdominal cavity, etc. Those skilled in the art will understand that this description is merely a description of illustrative examples of embodiments and is not intended as limiting the broader aspects of the present disclosure.

[0051] The foregoing description has broad applicability and is presented for purposes of illustration and description, and is not intended to limit the disclosure to the form disclosed herein. It will be understood that various additions, modifications, and substitutions may be made to the embodiments disclosed herein without departing from the concept, spirit, and scope of the present disclosure. In particular, it will be apparent to those skilled in the art that the principles of the present disclosure may be embodied in other forms, structures, arrangements, proportions, and using other elements, materials, and components without departing from the concept, spirit, scope, or characteristics thereof. For example, various features of the present disclosure are grouped together in one or more aspects, embodiments, or configurations for the purpose of streamlining the disclosure. However, it should be understood that various features of a particular aspect, embodiment, or configuration of the present disclosure may be combined into alternative aspects, embodiments, or configurations. While the present disclosure is presented in terms of embodiments, it should be understood that various individual features of the present subject matter need not all be present to achieve at least some of the desired properties and / or advantages of the present subject matter, or such individual features. Those skilled in the art will understand that the present disclosure can be used with many modifications or variations in the structure, arrangement, proportions, materials, components, and the like used in implementing the disclosure. These modifications or variations are specifically adapted to particular environments and operating requirements, and do not depart from the principles, spirit, or scope of the present disclosure. For example, elements shown as integrally formed may be constructed from multiple pieces, or elements shown as multiple pieces may be integrally formed, operations of elements may be reversed or otherwise varied, and sizes or dimensions of elements may be varied. Similarly, although operations or actions or steps are described in a particular order, this should not be construed as requiring such a specific order to achieve desired results, or that all operations or actions or steps should be performed. Furthermore, other implementations are within the scope of the following claims. In some cases, the actions recited in the claims can be performed in a different order and still achieve desired results.The presently disclosed embodiments are therefore to be considered in all respects as illustrative and not restrictive, and the scope of claimed subject matter is indicated by the appended claims and is not limited to the foregoing description or the specific embodiments or arrangements described or illustrated herein.

[0052] In the foregoing description and in the claims that follow, it will be understood that: As used herein, the phrases "at least one," "one or more," and "and / or" are open-ended expressions that are both conjunctive and disjunctive in operation. For example, terms such as "a," "an," "the," "first," "second," etc. do not preclude a plurality. For example, the terms "a" or "one" entity, as used herein, refer to one or more of that entity. Thus, the terms "a" (or "one"), "one or more," and "at least one" may be used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally used in its sense including "and / or" unless the content clearly dictates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly dictates otherwise, and the conjunction "or" includes one or more of the structures, components, features, etc. so connected, alone and in any combination and number, unless the context clearly dictates otherwise. All directional references (e.g., proximal, distal, top, bottom, upward, downward, left, right, lateral, longitudinal, front, rear, top, bottom, upper, lower, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used solely for identification purposes to aid the reader's understanding of this disclosure and / or serve to distinguish regions of related elements from one another, and do not limit the elements, particularly with respect to position, orientation, or use of this disclosure. References to connections (e.g., attached, coupled, connected, engaged, joined, etc.) should be construed broadly and may include intermediate members between and relative movement between groups of elements, unless otherwise indicated. Thus, connective references do not necessarily imply that two elements are directly connected and in fixed relationship to each other. Distinguishing references (e.g., primary, secondary, first, second, third, fourth, etc.) are not intended to imply importance or priority, but are used to distinguish one feature from another.

[0053] The following claims are incorporated into the Detailed Description herein by this reference, with each claim standing on its own as a separate embodiment of the present disclosure. In the claims, the terms "comprises," "comprising," "includes," and "comprising" do not exclude the presence of other elements, components, features, groups, regions, integers, steps, operations, etc. In addition, although individual features may be included in different claims, these may in some cases be advantageously combined, and their inclusion in different claims does not imply that a combination of features is not feasible and / or advantageous. In addition, a reference to the singular does not exclude a plurality. Reference signs in the claims are provided merely as a clarifying example and should not be construed as limiting the scope of the claims in any way.

Claims

1. 1. An anchor delivery and deployment device comprising: an anchor garage configured to deliver an anchor therein; an atraumatic shield movable relative to the anchor garage; a biasing element configured to bias the atraumatic shield into position relative to the anchor garage; 1. An anchor delivery and deployment device comprising:

2. 10. The anchor delivery and deployment device of claim 1, further comprising an indicator of the relative position of the anchor garage and the atraumatic shield.

3. The anchor delivery and deployment device of claim 2 , wherein the indicator is a visual indicator.

4. The anchor delivery and deployment device of claim 2 or 3, wherein the indicator comprises at least one radiopaque marker.

5. The anchor delivery and deployment device of any one of claims 2 to 4, wherein the indicator generates a signal indicative of the relative position of the anchor garage and the atraumatic shield.

6. The anchor delivery and deployment device of any one of claims 2 to 5, wherein the indicator indicates when the anchor delivery and deployment device has contacted tissue.

7. The anchor delivery and deployment device of any one of claims 1 to 6, further comprising a limit stop positioned to limit relative movement between the anchor garage and the atraumatic shield.

8. 8. The anchor delivery and deployment device of claim 7, wherein the limit stop is positioned and configured to limit proximal retraction of the atraumatic shield relative to the anchor garage.

9. 9. The anchor delivery and deployment device of claim 1, wherein a distal end of the anchor garage is sharp to penetrate tissue, and the biasing element biases the atraumatic shield onto the distal end of the anchor garage.

10. 10. The anchor delivery and deployment device of claim 1, wherein the biasing element includes a plurality of elongated beams proximal to the atraumatic shield, the plurality of elongated beams being biased into an elongated configuration along the anchor garage to bias the atraumatic shield distal to the anchor garage.

11. 11. The anchor delivery and deployment device of claim 10, wherein the beam is formed from a wall of the anchor garage.

12. 1. An anchor delivery and deployment system comprising: Anka and an anchor garage configured to deliver the anchor therein; an atraumatic shield movable relative to the anchor garage; a biasing element configured to bias the atraumatic shield into position relative to the anchor garage; 1. An anchor delivery and deployment system comprising:

13. 13. The anchor delivery and deployment system of claim 12, further comprising a tubular delivery element configured to transluminally deliver the anchor, the anchor garage, and the atraumatic shield through a patient's body to a target site.

14. 14. The anchor delivery and deployment system of claim 12 or 13, further comprising an indicator configured to indicate the relative position of the anchor garage and the atraumatic shield.

15. The anchor delivery and deployment system of any one of claims 12 to 14, further comprising a limit stop positioned to limit relative movement of the atraumatic shield with respect to the anchor garage.

Images