Devices, systems, and methods for deploying anchors to defined depth in tissue

Abstract

Devices, systems, and methods for delivering and deploying implantable devices are disclosed. The implantable device may be an anchor. The apparatus includes an anchor cartridge configured to deliver the anchor therein to a target site; and a non-invasive shield movable in relation to the anchor cartridge. A biasing element biases the non-invasive shield into a position associated with the anchor cartridge. In some embodiments, the distal end of the anchor cartridge is a sharp tissue penetrating end, and the non-invasive shield is distally biased over such sharp end. Limiting stoppers may be provided to limit the extent to which the anchor cartridge extends distally, thereby limiting tissue penetration by the anchor cartridge and the depth of deployment of the anchors. An indicator may be positioned and / or configured to provide an indication of the relative position of the anchor cartridge and the non-invasive shield.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims the benefit of priority to U.S. Provisional Application No. 63 / 424,373, filed on November 10, 2023, the entire disclosure of which is incorporated herein by reference for all purposes. Technical Field

[0002] The present invention generally relates to the field of implantable medical devices. In particular, the present invention relates to devices, systems, and methods for implanting devices, such as anchor devices, into tissue. More particularly, the present invention relates to medical devices, systems, and methods for delivering and deploying devices, such as anchors, to a desired implantation depth in tissue. Background Art

[0003] Various medical procedures involve anchoring a device or system to tissue. For example, cardiac repair surgery involving the repair of a heart valve leaflet includes anchoring chordae tendineae extending at one end from the heart leaflet to cardiac tissue. More particularly, artificial chordae tendineae may be coupled from the heart valve leaflet to cardiac tissue, such as papillary muscle tissue or to the heart wall. A common technical challenge of such surgeries is the potential for displacement of the anchor, which can sometimes occur shortly after delivery. One suspected cause of such anchor displacement is myocardial necrosis. There remains a need for securing devices relative to the implant site in a manner that resists displacement of the device from the implant site. Summary of the Invention

[0004] This disclosure is provided to introduce a series of concepts in a simplified form, which will be further described in the following detailed description. This disclosure is not intended to necessarily identify the key features or essential features of the claimed subject matter, nor is it intended to help determine the scope of the claimed subject matter. It will be understood by those skilled in the art that various aspects and features of the present invention may be advantageously used alone in some cases, or in other cases in combination with other aspects and features of the present invention, whether or not described in this disclosure. The inclusion or exclusion of elements, components, etc. in this disclosure is not intended to limit the scope of the claimed subject matter.

[0005] According to various principles of the present invention, an anchor delivery and deployment device includes: an anchor cartridge configured to deliver an anchor therein; a non-invasive shield movable relative to the anchor cartridge; and a biasing element configured to bias the non-invasive shield into a position relative to the anchor cartridge.

[0006] Optionally, the anchor delivery and deployment device includes an indicator of the relative position of the anchor cartridge and the non-invasive 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 indicating the relative position of the anchor cartridge and the non-invasive shield. In some embodiments, the indicator indicates that the anchor delivery and deployment device has contacted tissue.

[0007] Additionally or alternatively, the anchor delivery and deployment device includes a limit stop positioned to limit relative movement between the non-invasive shield and the anchor cartridge. In some embodiments, the limit stop is positioned and configured to limit proximal retraction of the non-invasive shield relative to the anchor cartridge.

[0008] In some embodiments, the distal end of the anchor cartridge is sharp to penetrate tissue, and the biasing element biases the non-invasive shield against the distal end of the anchor cartridge. In some embodiments, the limit stop is positioned to limit the sharp distal end of the anchor cartridge from being pushed out of the non-invasive shield.

[0009] In some embodiments, the biasing element comprises a plurality of elongated beams located proximal to the non-invasive shield and biased along the anchor cartridge into an elongated configuration to bias the non-invasive shield toward the distal end of the anchor cartridge. In some embodiments, the beams are formed by a wall of the anchor cartridge.

[0010] According to various principles of the present invention, an anchor delivery and deployment system includes: an anchor; an anchor cartridge configured to deliver the anchor therein; a non-invasive shield movable relative to the anchor cartridge; and a biasing element configured to bias the non-invasive shield into a position relative to the anchor cartridge.

[0011] Optionally, the anchor delivery and deployment system includes a tubular delivery element configured to transluminally deliver the anchor, anchor cartridge, and non-invasive shield through the patient's body to the target site.

[0012] Optionally, the anchor delivery and deployment system includes an indicator configured to indicate the relative position of the anchor cartridge and the non-invasive shield.

[0013] Optionally, the anchor delivery and deployment device includes a positive stop positioned to limit relative movement of the atraumatic shield with respect to the anchor cartridge.

[0014] According to various principles of the present invention, a method for delivering and deploying an anchor to a target site within a patient's body includes: delivering the anchor to the target site within an anchor cartridge; contacting a non-invasive shield positioned relative to the anchor cartridge with tissue at the target site to retract the non-invasive shield proximally relative to the anchor cartridge; deploying the anchor into the target site; retracting the anchor cartridge proximally from the target site to allow a biasing element to bias the non-invasive shield distally relative to the anchor cartridge; and retracting the anchor cartridge and the non-invasive shield from the target site.

[0015] The method optionally further includes causing an indicator positioned relative to the non-invasive shield and the anchor cartridge to indicate the relative positions of the non-invasive shield and the anchor cartridge.

[0016] The method optionally further includes advancing the anchor cartridge and the non-invasive shield distally against the tissue to retract the non-invasive shield proximally relative to the anchor cartridge until the non-invasive shield is prevented from further proximal movement by encountering a limit stop.

[0017] The method optionally further includes allowing the biasing element to bias the non-invasive shield distally relative to the anchor cartridge and returning the biasing element to a configuration in which the anchor cartridge, non-invasive shield, and biasing element can be retracted into the delivery device for withdrawal from the patient.

[0018] These and other features and advantages of the present invention will become apparent from the following detailed description, and the scope of the invention as claimed is set forth in the appended claims. Although the following disclosure is presented in terms of various aspects or embodiments, it should be understood that individual aspects may be claimed alone or in combination with various aspects and features of that or any other embodiment. BRIEF DESCRIPTION OF THE DRAWINGS

[0019] Non-limiting embodiments of the present invention are described by way of example with reference to the accompanying drawings, which are schematic and not intended to be drawn to scale. The drawings are provided for illustrative purposes only, and the dimensions, positions, order, and relative sizes reflected in the figures in the drawings may vary. For example, the device can be enlarged so that details are discernible, but is intended to be reduced with respect to, for example, fitting within a delivery catheter or working channel of an endoscope. In the drawings, identical or nearly identical or equivalent elements are generally indicated by the same drawing, and similar elements are generally designated by similar reference numerals that differ in increments of 100, with redundant descriptions omitted. For clarity and simplicity, not every element is labeled in every figure, and not every element of each embodiment shown is necessary to allow a person of ordinary skill in the art to understand the present invention.

[0020] The detailed description will be better understood with reference to the accompanying drawings, in which like reference characters represent like elements, as follows:

[0021] Figure 1 shows a perspective view of an example of an embodiment of an anchor delivery and deployment device and system formed in accordance with various principles of the present invention shown with a schematic representation of a heart for deployment in cardiac tissue;

[0022] Figure 2 Shown as Figure 1 a perspective view of the anchor delivery and deployment device and system shown, wherein the anchor delivery and deployment device is shown in a delivery configuration;

[0023] Figure 3 Shows something like Figure 2 , but with the anchor delivery and deployment device in a deployed configuration;

[0024] Figure 4A Shown as Figure 1 An elevational view of the anchor delivery and deployment device is shown delivering the anchor device into a tissue wall;

[0025] Figure 4B Shows something like Figure 4A but after the anchor device has been deployed and the anchor delivery and deployment device has been withdrawn from the tissue wall;

[0026] Figure 5 A perspective view of another example of an embodiment of an anchor delivery and deployment device and system formed according to various principles of the present invention is shown. DETAILED DESCRIPTION

[0027] The following detailed description should be read with reference to the accompanying drawings, which depict illustrative embodiments. It should be understood that the present invention is not limited to the specific embodiments described and is therefore subject to variation. 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 invention. Each example of the embodiments is provided by way of explanation and is not the only way to implement these principles, but rather merely an example. Therefore, references to elements, structures, or features in the accompanying drawings must be understood as references to examples of embodiments of the present invention and should not be construed as limiting the present invention to the specific elements, structures, or features 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 invention 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 another embodiment to produce a further embodiment. Therefore, the present subject matter is intended to cover such modifications and variations within the scope of the appended claims and their equivalents.

[0028] It should be understood that the present invention is set forth in various levels of detail in this application. In some cases, details that are not necessary for a person of ordinary skill in the art to understand the present invention, or details that make other details difficult to perceive, may have been omitted. The terms used herein are used only to describe specific embodiments and are not intended to be limiting beyond the scope of the appended claims. Unless otherwise specified, the technical terms used herein are to be understood as commonly understood by a person of ordinary skill in the art to which the present invention belongs. According to the present invention, all devices and / or methods disclosed and claimed herein can be made and performed without undue experimentation.

[0029] As used herein, "proximal" refers to the direction or position closest to a user (a medical professional or practitioner or clinician or technician or operator or physician, etc., such terms are used interchangeably herein and are not intended to be limiting, and include automated controller systems or others), such as when the device is being used (e.g., when the device is introduced into a patient, or during implantation, positioning, or delivery) and / or closest to a delivery device, and "distal" refers to the direction or position farthest from a user, such as when the device is being used (e.g., when the device is introduced into a patient, or during implantation, positioning, or delivery) and / or closest to a delivery device. "Longitudinal" means extending along the longer or larger dimension of an element. "Longitudinal axis" extends along the longitudinal extent of an element, but is not necessarily straight and does not necessarily maintain a fixed configuration if the element flexes or bends, and "axial" generally refers to along the longitudinal axis. However, it should be understood that references to axial or longitudinal movement with respect to the above-described systems or elements thereof are not necessarily limited to axial and / or longitudinal movement along the longitudinal axis or central axis of the referenced element. "Center" means at least generally bisecting a center point and / or being generally equidistant from a periphery or boundary, and "central axis" means a line, relative to an opening, that at least generally bisects the center point of an opening, which extends longitudinally along the length of the opening when the opening comprises, for example, a tubular element, a passage, a cavity or a hole. As used herein, a "cavity" or "passageway" or "hole" or "passageway" is not limited to a circular cross-section. As used herein, the "free end" of an element is the terminal end beyond which such element does not extend. It should be understood that unless otherwise indicated, terms such as, at or on or adjacent to or along an end are used interchangeably herein, are not intended to be limiting, and are intended to indicate a generally relative spatial relationship, rather than a position to be limited to a precisely defined limit. Finally, reference to "at" a position or location is intended to include at and / or near such position or location (e.g., along or adjacent to, etc.).

[0030] According to various principles of the present invention, implantable devices, such as anchor devices, are deployed deeply into tissue to securely anchor thereto and resist displacement therefrom. It should be understood that the term anchor is used for convenience and can be used interchangeably herein with terms such as anchor components, anchor devices, anchor elements, anchor mechanisms, anchoring components, anchoring devices, anchoring elements, anchoring mechanisms, etc., which are known in the art to represent structures configured to hold another object in place. For convenience and not intended to be limiting, reference is made herein to anchors. It should be understood that references to anchors herein, included in the claims, are used for convenience and can encompass other medical devices to be implanted, unless otherwise expressly indicated. It should also be understood that terms such as implants (and their other grammatical forms) can be used interchangeably herein with terms (and their grammatical forms), such as attachment, anchoring, attachment, association, connection, engagement, embedding, gripping, holding, grasping, fixing, etc., and are not intended to be limiting.

[0031] In order to control the deployment depth of the anchor (e.g., to ensure sufficient engagement with the tissue, and optionally to limit excessive depth of insertion, such as to avoid completely piercing the tissue wall to which the device is anchored), the anchor delivery and deployment device is configured to facilitate deployment of the anchor to a specified depth. The delivery device can be configured according to various principles of the present invention to pierce the tissue to a specified depth before deploying the anchor. The device can also be configured to indicate that a specified insertion depth has been reached so that the anchor can be deployed subsequently. For example, it may be desirable to insert the anchor deeply into tissue where necrosis is unlikely to occur. In addition, the fixing features on the anchor can be optimized for retention force independent of the insertion depth. For example, the width, thickness, number, degree of expansion, etc. of the claws of the anchor can be adjusted to achieve a desired retention force relative to the tissue.

[0032] More particularly, according to various principles of the present invention, an anchor delivery and deployment device includes an anchor cartridge having an inner cavity in which the anchor is delivered and from which the anchor is deployed. As referred to herein, the anchor cartridge is typically a tubular element having a cavity sized, shaped, formed, and / or dimensioned to accommodate the anchor therein so that the anchor cartridge having the anchor therein can be delivered to a target site within the patient's body. The distal end of the anchor cartridge can have a sharp needle tip (e.g., configured to penetrate tissue) or can be blunt. In addition, according to various principles of the present invention, a non-invasive shield is movably mounted relative to the anchor cartridge to indicate and / or control the insertion depth of the anchor into the tissue. The shield can be spring-biased to extend over the distal end of the anchor cartridge. However, when the anchor delivery and deployment device engages tissue at the deployment site, the non-invasive shield retracts proximally relative to the distal end of the anchor cartridge (e.g., overcoming the spring biasing force). If the distal end of the anchor cartridge is sharp, the non-invasive shield can shield the sharp end of the anchor cartridge before retracting and allowing the anchor cartridge to be advanced into the tissue at the deployment site for anchoring. The anchor delivery and deployment device can include a limit stop for the non-invasive shield. Once the non-invasive shield reaches the limit stop, the anchor cartridge is properly positioned to achieve the desired deployment of the anchor. In some cases, the limit stop is used to limit the extent to which the distal end of the anchor cartridge can extend beyond the non-invasive shield and into the tissue. The anchor delivery and deployment device can include any of a variety of indicators that allow the medical professional deploying the anchor to determine that the anchor delivery and deployment device has engaged the tissue and / or has reached the desired insertion depth. For example, the limit stop can serve as an indicator that the distal end of the anchor cartridge is fully engaged with the tissue, providing confidence that the anchor will be properly deployed into the tissue, such as achieving full deployment of the anchor at the desired depth within the tissue. Other indicators can be positioned and / or configured to provide an indication of the relative position of the anchor cartridge and the non-invasive shield. Additionally or alternatively, the indicator can generate a signal indicating the relative position of the anchor cartridge and the non-invasive shield. In the event that the distal end of the anchor cartridge is relatively blunt and not configured to pierce tissue at the target site, indicating that the anchor delivery and deployment device has engaged the tissue, such as to a desired degree, allows the medical professional to deploy the anchor from the anchor cartridge once appropriate tissue contact has been achieved, thereby enhancing the deployment of the anchor into the tissue (e.g., ensuring a secure fixation of the anchor to the tissue). As will be understood, the delivery, deployment, and engagement of the anchor can be facilitated by the use of known medical visualization techniques, such as fluoroscopy, ultrasound, intracardiac echography, etc. The indicator can be configured to be imaged or otherwise sensed using such techniques or other techniques known to those of ordinary skill in the art, and the invention is not limited in this respect.

[0033] Examples of embodiments of the devices described herein provide various devices, systems, or tools for anchoring relative to anatomical structures, such as, but not limited to, the heart. One example of a procedure that may utilize the devices, systems, and methods of the present invention is the treatment of heart disease. More particularly, the devices, systems, and methods described herein can be used in conjunction with a device or system for repositioning, repairing, and / or replacing one or more leaflets and / or chordae of a valve to treat heart disease. The repositioning, repair, and / or replacement of one or more leaflets and / or chordae of a valve can include one or more devices to secure to one or more leaflets of a heart valve, as well as to cardiac tissue, such as papillary muscle tissue. A leaflet clip can be attached to a heart valve leaflet, and artificial chordae extend from it and are anchored relative to the heart with an anchor, such as to cardiac tissue, such as papillary muscle tissue.

[0034] The anchor may include a plurality of tissue engaging claws configured to pierce the tissue to which the anchor is to be anchored. According to various principles of the present invention, the anchor is delivered in a delivery configuration in an anchor cartridge provided with an atraumatic shield (as described above). The delivery configuration may be a compact or compressed configuration. The anchor is removed from the anchor cartridge and transitioned to a deployed configuration. The deployed configuration may be an open or expanded configuration having outer dimensions that are larger than the outer dimensions of the anchor in the delivery configuration and larger than the inner diameter of the anchor cartridge.

[0035] The anchor claws can be biased into (and held in place) a transport configuration for transport to a deployment site within the anchor magazine. When extending from the anchor magazine to anchor relative to the tissue at the deployment site, the claws can be biased to extend into a deployed configuration, such as a curved or arched configuration. For example, the claws can be biased to extend into an expanded configuration for deployment, which is the neutral configuration of the claws. The anchor magazine can constrain or hold the anchor claws in a compact configuration to fit within the inner diameter of the anchor magazine. In some embodiments, the claws of the anchor extend or elongate in the compact configuration to extend along the longitudinal axis of the anchor magazine. An actuator, such as a push rod, can be used to move the anchor out of the anchor magazine for deployment in body tissue. Once the anchor is no longer within the anchor delivery and deployment device, the claws of the anchor can be moved to an open configuration, such as an expanded configuration. If the claws are spring-biased into the deployment configuration, it is important to advance the distal tip of the claws into the tissue so that the claws expand when they are within the tissue at the deployment site, rather than expanding outside the tissue. The distal ends of the anchor jaws can be configured to pierce and penetrate tissue and to expand into a deployed configuration that is secured within body tissue.

[0036] Examples of devices, systems, and methods that may be used to implement embodiments of the present invention include, but are not limited to, U.S. Patent Application Publication US2021 / 0000597, published on January 7, 2021, entitled Devices, Systems, and Methods for Adjustably Tensioning Artificial Chordae Tendinae Between Leaflets and Papillary Muscles or Heart Wall; U.S. Patent Application Publication US2021 / 0000598, published on January 7, 2021, entitled Devices, Systems, and Methods for Anchoring Artificial Chordae Tendinae to Papillary Muscles or Heart Wall; and U.S. Patent Application Publication US2021 / 0000599, published on January 7, 2021, entitled Devices, Systems, and Methods for Adjustably Tensioning Artificial Chordae Tendinae in Heart. Those described in U.S. Patent Application Publication No. US2022 / 0096235, entitled "Device, System, and Method for Anchoring an Artificial Key to Cardiac Tissue," published on March 2, 2023; U.S. Patent Application Publication No. US2023 / 0062599, entitled "Device, System, and Method for Anchoring an Artificial Key to Cardiac Tissue," published on March 2, 2023; and U.S. Patent Application Publication No. US2023 / 0123832, entitled "Device, System, and Method for Clamping a Heart Valve Leaflet," published on April 20, 2023, the entire contents of each of which are incorporated herein by reference and for all purposes. The examples of the devices described herein may be modified to incorporate embodiments or one or more features of the present invention.

[0037] Examples of embodiments of the devices described herein can provide anchoring of various devices, systems, or tools relative to anatomical structures, such as the heart. It should be understood that the devices and systems described herein can be used with devices or systems disclosed in the above-referenced applications incorporated herein, or can be used with other devices and systems, such as those described herein.

[0038] It should be understood that while the figures illustrate ventricular and mitral valve repair, the principles of the present invention are applicable to other cardiac structures, including but not limited to the tricuspid valve. Furthermore, while the present invention illustrates leaflet repair and anchoring of artificial chordae to papillary muscles, the principles of the present invention are applicable to devices other than the illustrated anchors, to procedures other than leaflet repair (whether or not involving anchoring of artificial chordae to cardiac tissue), and to procedures other than cardiac surgery.

[0039] Various embodiments of devices, systems, and methods for delivering and deploying implantable devices, such as anchors, will now be described with reference to the examples illustrated in the accompanying drawings. References throughout this specification to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., indicate that one or more specific features, structures, concepts, and / or characteristics according to the principles of the present invention may be included in conjunction with that embodiment. However, such references do not necessarily imply that all embodiments include a particular feature, structure, concept, and / or characteristic, or that one 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 can be combined with one or more of the features, structures, concepts, and / or characteristics of any of the other embodiments provided herein. That is, any of the features, structures, concepts, and / or characteristics described herein can be mixed and matched to create hybrid embodiments, and such hybrid embodiments are within the scope of the present invention. Furthermore, references throughout this specification to "one embodiment," "an embodiment," "some embodiments," "other embodiments," etc., do not necessarily refer to the same embodiment, nor are they necessarily separate or alternative embodiments that are mutually exclusive of other embodiments. It should also be understood that the various features, structures, concepts and / or characteristics of the disclosed embodiments are independent and separable from each other and can be used or presented individually or in various combinations with each other to create alternative embodiments that are considered to be part of the present invention. Therefore, the present invention is not limited to the embodiments specifically described herein, as describing all possible combinations and sub-combinations of features, structures, concepts and / or characteristics would be too cumbersome, and the examples of the embodiments disclosed herein are not intended to limit the broader aspects of the present invention. It should be understood that the various dimensions provided herein are examples, and that one of ordinary skill in the art can readily determine the appropriate range of standard deviations and acceptable variations covered by the present invention and any claims associated therewith. The following description is merely an illustrative example of an embodiment and is not intended to limit the broader aspects of the present invention.

[0040] It should be understood that common features are identified by common reference elements, and for the sake of brevity and convenience and not intended to be limiting, the description of common features is usually not repeated. For the sake of clarity, not all parts with the same reference numerals are numbered. In addition, a group of similar elements can be indicated by numbers and letters, and usually only a number can be used to refer to an element or such an element or such an element as a group (excluding the letters associated with each similar element). It should be understood that in the following description, similar elements or parts with reference numerals greater than 100 in the various illustrated embodiments are generally indicated by multiples of 100 with the same reference numerals, and for the sake of brevity, redundant descriptions are usually omitted. In addition, some features in one embodiment can be used across different embodiments and do not need to be individually marked when appearing in different embodiments.

[0041] Turning now to the accompanying drawings, Figure 1 1 and 2. Anchor delivery and deployment system 100 formed in accordance with various principles of the present invention is shown in FIG. 1 and is positioned to deploy an anchor into a heart wall. Anchor delivery and deployment system 100 includes an anchor delivery and deployment apparatus 110 and an anchor 120. Anchor delivery and deployment apparatus 110 includes an anchor cartridge 130 configured to deliver and deploy anchor 120. Anchor cartridge 130 may be alternatively referred to herein as a delivery housing, sheath, etc., without limitation. As shown in FIG. Figure 2 and Figure 3 It will be appreciated that the anchor 120 is delivered within the anchor cartridge 130 in a substantially unexpanded delivery configuration. Figure 2 In the example of the embodiment shown, the anchor cartridge 130 has a sharp distal tip 131 that is configured to penetrate tissue at the target site TS to facilitate deployment of the anchor 120, as described below with reference to FIG. Figure 4A and Figure 4B Alternatively, the distal tip of the anchor cartridge may be blunt, such as Figure 5 as shown, as discussed in more detail below.

[0042] According to various principles of the present invention, a non-invasive shield 140 is movably positioned relative to the distal tip 131 of the anchor cartridge 130. The non-invasive shield 140 is configured to move proximally relative to the anchor cartridge 130, such as when contacting tissue at the target site TS. In some embodiments, the non-invasive shield 140 covers the distal tip 131 of the anchor cartridge 130 during delivery and can be retracted proximally to expose the distal tip 131 of the anchor cartridge 130, such as when the anchor 120 is to be deployed from the anchor cartridge 130. Movement of the non-invasive shield 140 can provide confirmation that the anchor delivery and deployment device 110 is in contact with tissue and / or can ensure engagement of the anchor 120 with the tissue to ensure complete and full deployment of the anchor 120 (e.g., confirming / ensuring that all of its prongs are deployed in the tissue) and / or can ensure a desired penetration and deployment depth of the anchor 120, and can provide various other benefits, such as described in more detail below.

[0043] The non-invasive shield 140 may be biased distally toward the distal end 131 of the anchor cartridge 130 by a biasing element 150. The biasing element 150 maintains the non-invasive shield 140 in a distal position adjacent to (eg, covering) the distal end 131 of the anchor cartridge 130, such as Figure 1 and Figure 2 The biasing element 150 can move (eg, contract or bend or bow or otherwise change shape) to allow the non-invasive shield 140 to retract proximally relative to the anchor cartridge 130, such as Figure 3 As shown. For example, application of a force to the distal end 141 of the non-invasive shield 140 and / or the distal end 141 of the non-invasive shield 140 encountering another object, such as a tissue wall (e.g., at the target site TS) may cause the biasing element 150 to allow the non-invasive shield 140 to be retracted. The biasing element 150 can be configured to return the non-invasive shield 140 to the distal position when the force on the non-invasive shield 140 or the obstruction associated with the non-invasive shield 140 is removed. For example, in some cases, it may be desirable to retract the anchor delivery and deployment device 110 into the tubular element 160, in which the anchor delivery and deployment device 110 can be delivered transluminally within the patient's body to the target site TS (such as Figure 1 ). The tubular member 160 may be a delivery shaft or another device such as Figure 1 A leaflet clip delivery device 162 is shown that delivers and deploys a leaflet clip 164 onto a heart valve leaflet with artificial chords 166 extending therefrom to anchors 120 within anchor cartridge 130. In such instances, it may be desirable for the biasing element 150 to return to a configuration that allows the anchor delivery and deployment device 110 to be retracted into a tubular element, such as one or more tubular elements into which the anchor delivery and deployment device 110 has been delivered to the target site TS.

[0044] exist Figure 2 In the example of the embodiment shown, the biasing element 150 includes one or more resilient beams 152. The beams 152 maintain the non-invasive shield 140 in a distal position adjacent to (eg, covering) the distal end 131 of the anchor cartridge 130, such as Figure 1 and Figure 2 As shown. The distal end 151 of the beam engages or contacts the non-invasive shield 140, and the proximal end 153 of the beam 152 engages or contacts the anchor cartridge 130. For example, the distal end 151 and / or the proximal end 153 can be coupled to and / or fixed relative to the non-invasive shield 140 and the anchor cartridge 130, respectively. It should be understood that terms such as engaging, contacting, coupling, fixing, etc. and their other grammatical forms can be used interchangeably herein and are not intended to be limiting unless expressly stated. In some embodiments, the beam 152 is integrally formed with the anchor cartridge 130, such as by cutting (e.g., laser cutting) from a wall of the anchor cartridge 130. The distal end 151 of the beam 152 can be separated from the anchor cartridge 130 and attached to the non-invasive shield 140 (in any desired manner known to those of ordinary skill in the art, such as welding, soldering, brazing, or mechanical coupling, such as an interference fit). In some embodiments, the beam 152 is formed separately from the anchor cartridge 130 and optionally fits on a wall of the anchor cartridge 130 or within a cutout in a wall of the anchor cartridge 130. The distal end 151 of the beam can be attached to the non-invasive shield 140 in the manner described above. The proximal end 153 can be attached to the anchor cartridge 130 in a manner similar to the attachment of the proximal end 153 to the non-invasive shield 140. Alternatively, the ends 151, 153 can be retained relative to the anchor cartridge 130 and / or non-invasive shield 140 using a friction fit or interference fit or other mechanical coupling, such as is known to those of ordinary skill in the art.

[0045] like Figure 2 and Figure 3 The spring beams 152 of the exemplary embodiment of the biasing element 150 shown can bend, bend, bow, etc. to allow the non-invasive shield 140 to be retracted proximally relative to the anchor cartridge 130, such as Figure 3 As shown. For example, application of a force to the distal end 141 of the non-invasive shield 140 and / or the distal end 141 of the non-invasive 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. to allow retraction of the non-invasive shield 140. It should be understood that terms such as flex, bend, bow, shrink, deform, deflect, etc., including other grammatical forms thereof, may be used interchangeably herein and are not intended to be limiting. The beam 152 may be formed of a shape memory material (such as, but not limited to, a titanium alloy such as Nitinol or stainless steel) to bias the beam 152 in a selected configuration. For example, the shape memory of the beam 152 may cause the beam 152 to return to a neutral, resting position, such as when the force on the non-invasive shield 140 or an obstruction associated with the non-invasive shield 140 is removed. Figure 1 The beams 152 can be configured to return the non-invasive shield 140 to a distal position when a force on or obstruction relative to the non-invasive shield 140 is removed. The shape memory of the beams 152 can maintain the non-invasive shield 140 in a distal position, which can be the same as or close to the initial delivery position (before proximal retraction). When the anchor delivery and deployment device 110 is retracted into a tubular element (such as the shaft 160 into which the anchor delivery and deployment device 110 was delivered) after the anchor 120 has been deployed, the biasing element 150 can return the beams 152 to (or close to) the initial delivery position prior to the deployment of the anchor 120 for reinstallation into the tubular delivery element. It should be understood that the flexibility of the beams 152 can be adjusted or otherwise tailored to suit the specific use, environment, etc. of the biasing element 150, such as to adjust or achieve a desired degree of retraction of the non-invasive shield 140.

[0046] According to various principles of the present invention, and as described above, the distal end 141 of the non-invasive shield 140 can be blunt, curved, rounded, or otherwise configured to present a non-invasive surface for contacting tissue in a non-invasive manner. The size, shape, form, and dimensions of the blunt distal end 141 of the non-invasive shield 140 can be configured to facilitate pushing the non-invasive shield 140 against cardiac tissue without also pushing the distal end 141 of the non-invasive shield 140 into the cardiac tissue. For example, the distal end 141 of the non-invasive shield 140 can be rounded or curved inward (presenting a convex curved outer surface) or otherwise formed to be sufficiently blunt so as not to damage the tissue against which the anchor cartridge 140 pushes. For example, and without limitation, the edge of the distal end 141 of the non-invasive shield 140 can be curved at a radius of approximately 0.0275 inches (0.6985 mm). Pressing the distal end 141 of the non-invasive shield 140 against tissue can cause the non-invasive shield 140 to retract proximally (e.g., if the distal end 131 of the anchor cartridge 130 is proximal to the distal end 141 of the non-invasive shield 140). Such retraction can provide an indication of one or more conditions of interest to a medical professional. For example, proximal retraction of the non-invasive shield 140 can be used to indicate the position of the anchor delivery and deployment device 110 and / or to control and / or limit advancement of the anchor cartridge 130 and / or anchors 120 into tissue, as will be described with reference to FIG. Figure 4A and Figure 4B Examples of the embodiments shown and Figure 5 The embodiments shown are explained by way of example.

[0047] exist Figure 4A and Figure 4B In the example of the embodiment shown, such as Figure 2 and Figure 3The anchor delivery and deployment device 110 is shown being advanced into contact with the tissue wall TW at the target site TS. When the anchor delivery and deployment device 110 is advanced distally, the blunt distal end 141 of the non-invasive shield 140 is not advanced distally, but is retracted proximally relative to the anchor cartridge 130 and against the biasing force of the biasing element 150. The anchor delivery and deployment device 110 is provided with one or more indicators that are configured to provide information about the non-invasive shield 140 and / or the anchor cartridge 130 and / or their relative positions to a medical professional operating the anchor delivery and deployment system 100. Such information is useful in determining that the anchor delivery and deployment device 110 is in contact with the tissue at the target site TS so that the anchor 120 can be securely deployed to the tissue at the target site TS.

[0048] In some embodiments, at least a portion of the non-invasive shield 140 and / or anchor cartridge 130 is formed from a material that can be imaged using any of a variety of imaging systems (such as fluoroscopy and / or ultrasound and / or echocardiography), allowing a medical professional operating the anchor delivery and deployment system 100 to see when the non-invasive shield 140 is proximally retracted. This material can serve as an indicator. In some embodiments, the indicator is a limited area of ​​the non-invasive shield 140 and / or anchor cartridge 130 that is configured to enable the medical professional to visualize the movement of the non-invasive shield 140 and, optionally, the relative position of the non-invasive shield 140 and anchor cartridge 130. In some embodiments, the non-invasive shield 140 includes an indicator 142 in the form of one or more visual markers, such as radiopaque markers, bands, or radiopaque filler material, and the anchor cartridge 130 includes corresponding, generally similarly formed, indicators 132a, 132b. In some embodiments, the visual markers may be provided only on the anchor cartridge 130, such that when the non-invasive shield 140 is moved proximally, the non-invasive shield 140 covers or obscures the visual markers on the anchor cartridge 130. A medical professional can then determine the position of the non-invasive shield 140 relative to the anchor cartridge 130, such as if all visual markers are obscured or a certain number of visual markers (e.g., two-thirds of the markers) are obscured. The position of the indicator 142 on the non-invasive shield 140 relative to the indicators 132a, 132b on the anchor cartridge 130 can be viewed by various suitable imaging systems to provide the medical professional with information regarding the position, morphology, status, etc. of the anchor delivery and deployment device 110, such as information related to the target site TS. The relative position of the anchor cartridge 130 and the non-invasive shield 140 can be used to indicate the distal end 131 of the anchor cartridge 130 in a manner that ensures the anchor 120 contained therein engages the tissue in a manner that allows for desired deployment. The relative positions of the anchor cartridge 130 and the non-invasive shield 140 can indicate that the anchor 120 has been inserted with sufficient force / depth even for blunt systems (e.g., if the distal end 131 of the anchor cartridge 130 is blunt, as discussed in more detail below). For example, sufficient force can be achieved when the entire distal end 131 of the anchor cartridge 130 is in contact with the tissue wall. Optionally, an indicator can be provided on the anchor cartridge 130 and / or the non-invasive shield 140 that signals (audio, visual, etc.) when the non-invasive shield 140 has been retracted distally a selected distance. Such an indicator can be activated when elements of the non-invasive shield 140 and the anchor cartridge 130 meet in a manner known to those skilled in the art. For example, electrical sensors can be provided on the non-invasive shield 140 and the anchor cartridge 130 to generate a signal (audio or visual, such as an illuminated LED) when the non-invasive shield 140 is fully retracted.

[0049] Information from the indicator regarding the relative position of the non-invasive shield and the anchor cartridge extending therethrough may be useful for identifying to a medical practitioner when the anchor delivery and deployment device contacts tissue so that the device can be deployed (e.g., implanted into such tissue). Figure 4A and Figure 4B The anchor delivery and deployment device 110 is shown in contact with the tissue wall TW, and the anchor 120 of the anchor delivery and deployment system 100 can be advanced distally into the tissue wall TW, as shown. Figure 4A In embodiments where the anchor cartridge 130 has a sharp distal end 131, the distal end 131 of the anchor cartridge 130 may also be advanced distally into the target site TS, such as to facilitate deployment of the anchor 120, such as Figure 4A As shown and discussed in more detail below. Figure 5 In the example of the embodiment of the anchor delivery and deployment device 210 shown, the distal end 231 of the anchor cartridge 230 is generally blunt and not configured to penetrate tissue. Figure 5 As shown, the distal end 241 of the non-invasive shield 240 (shown in phantom so that the relative position of the anchor cartridge 230 therein can be viewed) extends distally of the distal end 231 of the anchor cartridge 230. Thus, the non-invasive shield 240 is in contact with the tissue wall (e.g., Figure 4A and Figure 4B As the non-invasive shield 240 contacts the tissue wall (TW) as shown and the anchor delivery and deployment apparatus 210 continues to be advanced distally, the non-invasive shield 240 can be retracted or pushed proximally relative to the anchor cartridge 230, with the non-invasive shield 240 extending relative to (e.g., over) the anchor cartridge 230. The proximal movement of the non-invasive shield 240 relative to the anchor cartridge 230 can continue until the blunt distal end 231 of the anchor cartridge 230 (initially located proximal to the distal end 241 of the non-invasive shield 240 and therefore not contacting the tissue wall) also contacts the tissue wall, at which point the effect of such contact on the non-invasive shield 240 is minimized, if not eliminated. When this position is reached, the medical practitioner can receive a tactile indication (e.g., resistance to further advancement of the anchor delivery and deployment apparatus 210). Additionally or alternatively, any of a variety of indicators can be used, such as those described above with respect to Figure 2 、 Figure 3 、 Figure 4A and Figure 4B The anchor delivery and deployment apparatus 110 shown is described above. For example, indicators that can be imaged by any of a variety of imaging systems can be provided on the non-invasive shield 240 and / or the anchor cartridge 230 so that relative movement therebetween can be observed, including whether a desired relative movement has been achieved (e.g., indicating sufficient contact with tissue to properly, completely, fully, etc. deploy the anchor 220).

[0050] In some embodiments, a limit stop 170 may be provided to limit the proximal retraction of the non-invasive shield 140. The limit stop 170 may also be another indicator that the anchor cartridge 130 is fully extended and / or in full contact with the tissue so that the anchor 120 can be deployed to a desired depth within the tissue. As described above, in some embodiments, such as Figure 4A and Figure 4B As shown, the anchor cartridge 130 of the anchor delivery and deployment device 110 can have a sharp distal end 131 that can be sharp enough to penetrate the tissue wall TW once the non-invasive shield 140 has been sufficiently retracted proximally to expose a sufficient extent of such sharp distal end 131. In such an embodiment, in addition to serving as an indicator that allows a medical practitioner to determine or observe the relative position of the non-invasive shield 140 and the anchor cartridge 130 to determine the proper positioning of the anchor cartridge 130 for deploying the anchor 120, the limit stop 170 can also limit the depth to which the sharp distal end 131 of the anchor cartridge 130 can penetrate the tissue wall TW. The limit stop 170 can be a protrusion (e.g., a detent or weldment) such as Figure 4A Additionally or alternatively, the stop may be formed from a portion of the anchor magazine, such as a stamped lug stop 270, such as Figure 5 As can be appreciated, the positive stops 170, 270 can provide various benefits regardless of whether the distal end of the anchor cartridge is sharp or blunt.

[0051] Once the anchors 120, 220 have been deployed from the anchor cartridges 130, 230, the biasing elements 150, 250 bias the non-invasive shield 140, 240 distally, such as to cover the distal ends 131, 231 of the anchor cartridges 130, 230 and / or to facilitate withdrawal of the anchor delivery and deployment device 110, 220 into a delivery shaft (e.g., a delivery shaft into which the anchor delivery and deployment device 110, 220 has been delivered), such as for withdrawal from a patient. Figure 4B As shown, once the anchor 120 has been deployed in the tissue wall TW, the biasing element 150 can return the atraumatic shield 140 to a position covering the sharp distal end 131 of the anchor cartridge 130 , such as to protect tissue from inadvertent contact with the sharp distal end 131 .

[0052] It should be understood that Figure 5 Other features of the anchor delivery and deployment system 100 of the illustrated anchor delivery and deployment device 210 may be substantially similar to Figures 1 to 3 、 Figure 4A and Figure 4BFor those of you who are familiar with the present invention, for the sake of brevity, reference is made to those figures and the associated descriptions of the elements and features shown therein. For example, the various features of the anchor delivery and deployment devices 110, 220 described above can be arranged and operate in a substantially identical or similar manner. Therefore, for the sake of brevity and convenience, and not intended to be limiting, common elements having common functionality are indicated by the same reference numerals that differ by 100, with reference to the above descriptions of similar elements and operations.

[0053] It should also be understood that all devices and methods discussed herein are examples of devices and / or methods implemented according to one or more principles of the present invention. These examples are not the only way to implement these principles, but are merely examples, and are not intended to limit the broader aspects of the present invention. Therefore, references to elements or structures or features in the accompanying drawings must be understood as references to examples of embodiments of the present invention, and should not be understood as limiting the present invention to the specific elements, structures or features shown. Other examples of ways to implement the disclosed principles will occur to those of ordinary skill in the art when reading this invention.

[0054] It should also be understood that any or all aspects of the above-described delivery and deployment may be performed using available appropriate imaging techniques, such as are known or heretofore known to those of ordinary skill in the art.

[0055] As noted above, while embodiments of the present invention may be described with particular reference to medical devices, systems, and procedures for deploying (e.g., anchoring) devices to tissue associated with the cardiovascular system (e.g., cardiac tissue), it should be understood that such medical devices and methods may also be used to treat tissue of the gastrointestinal system, the abdominal cavity, etc. Those skilled in the art will appreciate that this discussion is merely a description of illustrative examples of embodiments and is not intended to limit the broader aspects of the invention.

[0056] The above discussion has broad applicability and has been presented for purposes of illustration and description, and is not intended to limit the invention to the forms disclosed herein. It should 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 invention. In particular, it will be apparent to those skilled in the art that the principles of the invention may be implemented in other forms, structures, arrangements, proportions, and with other elements, materials, and components without departing from its concept, spirit, scope, or characteristics. For example, to simplify the invention, various features of the invention may be combined together in one or more aspects, embodiments, or forms. However, it should be understood that various features of certain aspects, embodiments, or forms of the invention may be combined in alternative aspects, embodiments, or forms. Although the invention is presented in the form of embodiments, it should be understood that the various individual features of the subject matter need not all be present in order to achieve at least some of the desired characteristics and / or benefits of the subject matter or such individual features. Those skilled in the art will understand that the invention may be used with numerous modifications or variations to the structures, arrangements, proportions, materials, components, and other features used in the practice of the invention, which modifications or variations are particularly suitable for specific environments and operational requirements without departing from the principles, spirit, or scope of the invention. For example, an element shown as being integrally formed may be composed of multiple parts or elements that are shown as being integrally formed, the operation of an element may be reversed or otherwise varied, and the size or dimensions of an element may vary. Similarly, although operations or actions or procedures are described in a particular order, this should not be understood as requiring such a particular order or that all operations or actions or procedures must be performed to achieve the desired result. Additionally, other embodiments are also within the scope of the following claims. In some cases, the actions recited in the claims may be performed in a different order and still achieve the desired result. Therefore, the presently disclosed embodiments should be considered in all respects to be illustrative and not restrictive, and the scope of the subject matter claimed is indicated by the appended claims and is not limited to the preceding description or the specific embodiments or arrangements described or shown herein. In view of the foregoing, individual features of any embodiment may be used and may be claimed alone or in combination with features of that embodiment or any other embodiment, and the scope of the subject matter is indicated by the appended claims and is not limited to the preceding description.

[0057] In the description above and in the claims below, the following will be understood. As used herein, the phrases "at least one", "one or more", and "and / or" are open-ended expressions that are both conjunctions and non-conjunctions in operation. The terms "one", "an", "the", "first", "second", etc. do not exclude a plurality. For example, the terms "one" or "an" entity as used herein refer to one or more of the entities. Therefore, the terms "one" (or "an"), "one or more", and "at least one" are used interchangeably herein. As used in this specification and the appended claims, the term "or" is generally adopted in the sense of including "and / or" unless the content clearly indicates otherwise. As used herein, the conjunction "and" includes each of the structures, components, features, etc. so connected, unless the context clearly indicates otherwise, and the conjunction "or" includes one or other of the structures, components, features, etc. so connected, individually and in any combination and quantity, unless the context clearly indicates otherwise. All directional references (e.g., proximal, distal, up, down, upward, downward, left, right, lateral, longitudinal, front, back, top, bottom, above, below, vertical, horizontal, radial, axial, clockwise, counterclockwise, and / or the like) are used for identification purposes only to assist the reader in understanding the present invention and / or to distinguish areas of associated elements from one another and do not limit the associated elements, particularly the position, orientation, or use of the present invention. Unless otherwise indicated, connection references (e.g., attach, couple, connect, join, and combine) are to be interpreted broadly and may include intermediate members between a collection of elements and relative movement between elements. In this regard, connection references do not necessarily imply that two elements are directly connected and in a fixed relationship to each other. Identification 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.

[0058] The following claims are hereby incorporated by this reference into the detailed description, with each claim standing on its own as a separate embodiment of the invention. In the claims, the terms "comprises," "comprising," "includes," and "including" do not exclude the presence of other elements, parts, features, groups, regions, integers, steps, operations, etc. Additionally, although individual features may be included in different claims, these features may be advantageously combined, and inclusion in different claims does not mean that a combination of features is not feasible and / or advantageous. Furthermore, singular references do not exclude the plural. Reference signs in the claims are provided merely as an example of clarification and should not be construed as limiting the scope of the claims in any way.

Claims

1. An anchor delivery and deployment device comprising: an anchor cartridge configured to deliver the anchor therein; a non-invasive shield movable relative to the anchor cartridge; as well as A biasing element is configured to bias the non-invasive shield into a position relative to the anchor cartridge.

2. The anchor delivery and deployment device of claim 1, further comprising an indicator of the relative positions of the anchor cartridge and the non-invasive shield.

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

4. An anchor delivery and deployment device according to any one of claims 2 to 3, wherein: The indicator includes at least one radiopaque marker.

5. An anchor delivery and deployment device according to any one of claims 2 to 4, wherein: The indicator generates a signal indicative of the relative positions of the anchor cartridge and the non-invasive shield.

6. An anchor delivery and deployment device according to any one of claims 2 to 5, wherein: The indicator indicates that 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 atraumatic shield and the anchor cartridge.

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

9. An anchor delivery and deployment device according to any one of claims 1 to 8, wherein: The distal end of the anchor cartridge is sharpened to penetrate tissue, and the biasing element biases the atraumatic shield against the distal end of the anchor cartridge.

10. An anchor delivery and deployment device according to any one of claims 1 to 9, wherein: The biasing element includes a plurality of elongated beams located proximal to the non-invasive shield and biased along the anchor cartridge into an elongated configuration to bias the non-invasive shield toward the distal end of the anchor cartridge.

11. The anchor delivery and deployment device of claim 10, wherein: The beams are formed by the walls of the anchor magazine.

12. An anchor delivery and deployment system comprising: anchors; an anchor cartridge configured to deliver the anchor therein; a non-invasive shield movable relative to the anchor cartridge; as well as A biasing element is configured to bias the non-invasive shield into a position relative to the anchor cartridge.

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

14. The anchor delivery and deployment system of any one of claims 12 to 13, further comprising an indicator configured to indicate the relative positions of the anchor cartridge and the non-invasive shield.

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

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