Multi-anchor delivery system and method

Abstract

A multiple-anchor delivery system comprising: a sheath having a passage extending therethrough; a pusher element having a distal end positioned within the passage, the pusher element sized and shaped to be displaced through the passage; a first anchor disposed within the sheath, a portion of the first anchor distal to the pusher element; and a second anchor disposed within the passage proximal to the first anchor, the second anchor sized and shaped to be displaced along the passage. The pusher element is sized and shaped to be displaced proximally to a position proximal to at least a distal portion of the second anchor. The pusher element is sized and shaped to be displaced distally by a second displacement length at least as long as the distance between the proximal end of the second anchor and the distal end of the sheath, the second displacement length being long enough to deploy the second anchor.

Description

[Technical field]

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority to U.S. Provisional Patent Application No. 62 / 591,132 to Alfia et al., filed November 27, 2017, the contents of which are incorporated by reference in their entirety herein.

[0002] The present invention relates generally to soft tissue repair systems, such as multiple anchor delivery systems. [Background technology]

[0003] Various surgical procedures are known to be performed to repair deformed or torn soft tissue, such as the meniscus, by means of suturing. There is a particular need for a system that allows for the delivery of several anchors during a single procedure.

[0004] U.S. Patent Nos. 8,888,798 and 9,357,994 to Smith & Nephew, Inc. each disclose a tissue repair device in which "advancing a knob can cause an actuator to engage a first anchor, which can then be advanced."

[0005] Smith & Nephew Incorporated's U.S. Patent Nos. 9,498,203 and 9,549,725 each disclose a tissue repair device that includes a "spring-loaded pusher" configured "for movement of a flexible member to secure tissue."

[0006] U.S. Patent No. 9,622,736 discloses a tissue repair device including "first and second tubular anchors having corresponding longitudinal passages. The tissue repair device includes corresponding first and second inserters. Each inserter has a shaft with a distal portion received in the longitudinal passage of the corresponding tubular anchor. A flexible strand connects the first and second anchors" (abstract).

[0007] Additional anchor repair devices are disclosed in U.S. Patent No. 5,954,747; U.S. Patent No. 6,306,156; U.S. Patent No. 5,980,558; U.S. Patent No. 5,993,459; U.S. Patent No. 6,146,407; U.S. Patent No. 6,595,911; U.S. Patent Application No. 2003 / 0167072; U.S. Patent Application No. 2008 / 0167660; U.S. Patent No. 9,249,266; U.S. Patent No. 9,173,645; U.S. Patent No. 5,236,445; No. 4,899,743; U.S. Patent No. 4,946,468; U.S. Patent No. 4,968,315; U.S. Patent No. 5,002,550; U.S. Patent No. 5,041,129; U.S. Patent No. 5,123,914; U.S. Patent No. 5,258,016; U.S. Patent No. 5,372,604; U.S. Patent No. 5,403,348; U.S. Patent No. 5,417,712; U.S. Patent No. 5,417,691; U.S. Patent No. 5,626,614; U.S. Patent No. 5,718,717; U.S. Patent No. 5,954,747; U.S. Patent No. 6,554,852; U.S. Patent No. 6,511,498; U.S. Patent No. 5,403,348; U.S. Patent No. 7,857,830; U.S. Patent No. 7,905,903; U.S. Patent No. 7,601,165; U.S. Patent No. No. 8,128,658; U.S. Patent No. 7,959,650; U.S. Patent No. 8,771,314; U.S. Patent No. 8,298,262; U.S. Patent No. 8,221,454; U.S. Patent Application No. 2014 / 0039552; U.S. Patent No. 8,652,172; U.S. Patent No. 8,828,053; U.S. Patent No. 9,463,011; and U.S. Patent No. 9,622,738. Summary of the Invention

[0008] The present invention seeks to provide an improved multiple anchor delivery system.

[0009] Thus, in accordance with some embodiments of the present invention, there is provided a multiple-anchor delivery system including a drive unit, a hollow needle extending distally from the drive unit, a pusher element operatively coupled to the drive unit and extending within the hollow needle distally from the hollow needle, a first solid anchor disposed within the hollow needle distal to the pusher element, and a second tubular anchor threaded onto the pusher element.

[0010] Preferably, at least one of the first and second anchors is bioabsorbable. More preferably, the drive unit includes a linearly displaceable trigger button. More preferably, the trigger button is configured to interact with a pinion. The pinion is configured for interaction with a rack to linearly displace the pusher element within the hollow needle. Preferably, the pusher element includes a release mechanism for releasing the second anchor during retraction of the pusher element. Optionally, instead of a linearly displaceable trigger button, the drive unit may be actuated by a rotatable roller configured to interact with the rack.

[0011] According to some embodiments of the invention, a method of delivering a plurality of anchors into tissue of a patient includes delivering a hollow needle into the tissue; displacing a trigger button in a first direction to deploy a first anchor into the tissue; displacing the trigger button in a second direction opposite the first direction to load a second anchor; and displacing the trigger button in the first direction to deploy the second anchor.

[0012] Preferably, the trigger button is displaced proximally to deploy at least one of the first and second anchors. More preferably, the trigger button is displaced distally to load the second anchor. Even more preferably, a tactile indication for anchor deployment or for anchor loading is provided to a user during displacement of the trigger button.

[0013] According to some embodiments of the invention, a catheter includes a sheath having a proximal end and a distal end and having a passage extending therethrough; a pusher element having at least a distal end positioned within the passage, the pusher element sized and shaped to be displaced through the passage; a first anchor disposed within the sheath, at least a portion of the first anchor disposed distally relative to the pusher element; and a second anchor disposed within the sheath proximally relative to the first anchor, the second anchor being sized and shaped to be displaced within the passage and displaced along the passage, the pusher element sized and shaped to be displaced in a proximal direction to a position proximal to at least a distal portion of the second anchor, the pusher element sized and shaped to be displaced in a distal direction, the displacement of the pusher element having a second displacement length at least as long as a distance between a proximal end of the second anchor and a distal end of the sheath, the second displacement length being sufficient to deploy the second anchor.

[0014] According to some embodiments of the invention, the second anchor axially overlaps the pusher element.

[0015] According to some embodiments of the invention, the second anchor is tubular.

[0016] According to some embodiments of the invention, the pusher element is sized and shaped to be displaced distally into contact with the first anchor, the displacement having a first displacement length sufficient to deploy the first anchor.

[0017] According to some embodiments of the invention, the system further includes a barrier that narrows the passageway, the barrier preventing proximal displacement of the second anchor.

[0018] According to some embodiments of the invention, the second anchor is mounted on the pusher element.

[0019] According to some embodiments of the present invention, the distal end of the pusher element includes an enlarged tip.

[0020] According to some embodiments of the invention, the pusher element extends through an interior of the second anchor.

[0021] According to some embodiments of the invention, the second anchor is laterally compressible.

[0022] According to some embodiments of the invention, the second anchor is laterally compressible and the pusher element is proximally displaceable to a position proximal to the second anchor.

[0023] According to some embodiments of the invention, the first anchor includes a blind bore at its proximal end and the distal end of the pusher element is sized and shaped to fit into the blind bore.

[0024] According to some embodiments of the invention, a distal end of the pusher element includes a retaining portion for temporarily retaining a second anchor thereon.

[0025] According to some embodiments of the invention, the retaining portion is a recess for retaining a second anchor.

[0026] According to some embodiments of the present invention, the pusher element comprises a compressible distal portion.

[0027] According to some embodiments of the invention, the first anchor is tubular.

[0028] According to some embodiments of the invention, at least one of the first and second anchors is provided with a channel along at least a portion of its length, the channel having a passage sized to allow a suture portion to pass therethrough.

[0029] According to some embodiments of the invention, the sheath comprises a hollow needle.

[0030] According to some embodiments of the present invention, the sheath has a lateral opening at its distal end that is large enough to allow the passage of at least two suture elements.

[0031] According to some embodiments of the invention, the sheath has a lateral opening at its distal end and the second anchor is positioned proximal to the lateral opening prior to deployment of the second anchor.

[0032] According to some embodiments of the invention, the sheath has a sharpened tip at its distal end.

[0033] According to some embodiments of the present invention, the distal end of the sheath is curved.

[0034] According to some embodiments of the invention, the system further includes an actuator mechanically coupled to the pusher element, where movement of the actuator affects a linear displacement of the pusher element along the pathway.

[0035] According to some embodiments of the invention, the system further includes a drive unit for displacing the pusher element through the passageway, the actuator being mechanically coupled to the drive unit.

[0036] According to some embodiments of the invention, a displacement of the actuator in a first direction affects, via the drive unit, a displacement of the pusher element in a second direction opposite to the first direction.

[0037] According to some embodiments of the invention, the first direction is one of a proximal direction and a distal direction.

[0038] According to some embodiments of the invention, the system further includes a housing for housing the pusher element and at least a proximal portion of the sheath, the housing having a semicircular portion at its distal end and a suture holder having a semicircular arm at its proximal end, the arm and housing portion together forming a passage sized for passage of the suture.

[0039] According to some embodiments of the invention, the system further comprises a locking element for preventing proximal displacement of the pusher element.

[0040] According to an embodiment of the invention, the system further comprises a drive unit for displacing the pusher element through the passageway, the locking element obstructing a movement path of the drive unit.

[0041] According to some embodiments of the invention, the first and second anchors are completely contained within the sheath prior to their deployment.

[0042] According to an aspect of some embodiments of the invention, there is provided a multiple-anchor delivery system comprising: a sheath having a proximal end and a distal end and having a passage extending therethrough; first and second pusher elements disposed within the sheath, each pusher element having at least a distal end positioned within the passage, the distal end of each pusher element sized and shaped to be displaced through the passage; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally relative to the first pusher element; and a second anchor disposed within the sheath proximally relative to the first anchor, wherein the first pusher element is displaceable in a distal direction into contact with the first anchor, the displacement having a displacement length sufficient to deploy the first anchor, and the second pusher element is displaceable in a distal direction into contact with the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.

[0043] In accordance with an aspect of some embodiments of the invention, there is provided a multiple-anchor delivery system comprising a sheath having a proximal end and a distal end and having a passage extending therethrough; a pusher element having at least a distal end positioned within the passage, the distal end of the pusher element sized and shaped to be displaced along the passage; a first anchor disposed within the sheath, at least a portion of the rigid first anchor positioned distally relative to the pusher element; and a second anchor disposed within the sheath proximally relative to the first anchor and mounted on the pusher element.

[0044] According to some embodiments of the invention, the second anchor is tubular.

[0045] According to some embodiments of the invention, a distal end of the pusher element includes a retaining portion for temporarily retaining a second anchor thereon.

[0046] According to some embodiments of the invention, the pusher element extends through an interior of the tubular second anchor.

[0047] According to aspects of some embodiments of the invention, there is provided a method of transferring multiple anchors into tissue of a patient including: advancing a sheath such that a distal end of the sheath penetrates the tissue; displacing an actuator proximally to deploy a first anchor from the sheath and through the tissue; displacing the actuator distally to position a proximal end of a pusher element at least partially proximally relative to a second anchor; and displacing the actuator proximally to engage and deploy the second anchor from the sheath.

[0048] According to some embodiments of the invention, the first anchor is provided with a suture portion, which is deployed from the sheath and through tissue upon deployment of the first anchor.

[0049] According to an aspect of some embodiments of the invention, there is provided a method of operating a device for deploying multiple anchors comprising: a first displacement of a pusher element in a distal direction through a sheath; engagement of the pusher element with a first anchor located in the sheath, the first displacement having a first displacement length sufficient to deploy the first anchor from the sheath; a displacement of the pusher element in a proximal direction through the sheath to a proximal position relative to a second anchor; a second displacement of the pusher element in the distal direction through the sheath; and engagement of the pusher element with the second anchor during the second displacement, the second displacement having a second displacement length sufficient to deploy the second anchor from the sheath.

[0050] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which the present invention pertains.Although methods and materials similar or equivalent to those described herein can be used in carrying out or testing embodiments of the present invention, exemplary methods and / or materials are described below.In case of conflict, the patent specification, including definitions, shall prevail.In addition, the materials, methods, and examples are illustrative only and are not necessarily intended to be limiting. [Brief description of the drawings]

[0051] Some embodiments of the present invention are described herein, by way of example only, with reference to the accompanying drawings. Referring now specifically to the drawings, it is emphasized that the particulars shown are by way of example and for the purpose of illustrative discussion of the embodiments of the present invention. In this regard, the description with reference to the drawings will make apparent to those skilled in the art how the embodiments of the present invention may be practiced. [Figure 1] 1A-1C are simplified cross-sectional views of an exemplary multi-anchor delivery system and a close-up of its distal end, shown in an initial operational orientation, according to some embodiments of the present invention. [Diagram 2]1A-1C are simplified cross-sectional views of a multiple-anchor delivery system and a close-up of its distal end, shown in a first anchor deployment operational orientation, according to some embodiments of the present invention. [Diagram 3] 1A-1C are simplified cross-sectional views of a multiple-anchor delivery system and a close-up of its distal end, shown in a retracting operating orientation, according to some embodiments of the present invention. [Figure 4] 1A-1C are simplified cross-sectional views of a multiple anchor delivery system and a close-up of its distal end shown in a deployment operational orientation of a second anchor, according to some embodiments of the present invention. [Diagram 5] 1 is a perspective view of an exemplary multiple anchor delivery system, according to some embodiments of the present invention. [Figure 6] FIG. 6 is an exploded view of the device shown in FIG. 5 according to some embodiments of the present invention. [Figure 7] 7A-7E are corresponding left side, left perspective, right side, bottom, and end views of the right half of an exemplary housing of the device shown in FIG. 6, according to some embodiments of the present invention. [Figure 8] 8A-E are corresponding perspective, top, side, bottom, and front views of an exemplary rack, according to some embodiments of the present invention. [Figure 9] FIG. 9A is a perspective view of an exemplary roller according to some embodiments of the present invention, and FIGS. 9B-C are side views of an exemplary roller according to alternative embodiments of the present invention. [Figure 10] 10A-D show corresponding perspective, top, side, and end views of an exemplary bobbin, according to some embodiments of the present invention. [Figure 11] 11A-D show corresponding perspective, front, side, and top views of an exemplary locking element, according to some embodiments of the present invention. [Figure 12] 12A-E show corresponding perspective, side, top, end, and cross-sectional views of an exemplary needle length delimiter, according to some embodiments of the present invention. [Figure 13]Figure 13A is a perspective view of an exemplary sheath, according to some embodiments of the present invention, and Figure 13D shows a close-up view of its distal end, and Figures 13B-C are corresponding cross-sectional and top views of the sheath shown in Figure 13A, according to some embodiments of the present invention. [Figure 14] FIG. 14A is a side view of an exemplary pusher element, and FIG. 14B shows an enlarged view of a distal portion thereof, according to some embodiments of the present invention. [Figure 15] 15A-C are corresponding perspective, side, and top views of an exemplary suture holder, according to some embodiments of the present invention, and FIGS. 15D-E are corresponding side and top views of an exemplary cannula, according to some embodiments of the present invention. [Figure 16] 16A-C are corresponding perspective, cross-sectional, and top views of exemplary first and second anchors having sutures disposed therethrough, according to some embodiments of the present invention. [Figure 17] 17A-D are a side cross-sectional view with an enlarged view of a portion of an exemplary system, an enlarged view of a distal portion of the system, a top view of the system, and a side view of the system, according to some embodiments of the present invention. [Figure 18] 18A-D are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 17A with an enlarged view of the distal portion of the system shown in FIG. 18B after inserting its distal end into tissue, in accordance with some embodiments of the present invention. [Figure 19-1] 19A-B are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 18A with an enlarged view of a distal portion of the system shown in FIG. 19B after deployment of a first anchor through tissue, according to some embodiments of the present invention. [Figure 19-2] 19C-D are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 18A with an enlarged view of a distal portion of the system shown in FIG. 19B after deployment of a first anchor through tissue, according to some embodiments of the present invention. [Figure 19-3]19E-F are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 19A with an enlarged view of the distal portion of the system shown in FIG. 19F after retraction of the pusher element, according to some embodiments of the present invention. [Figure 19-4] 19G-H are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 19A with an enlarged view of the distal portion of the system shown in FIG. 19F after retraction of the pusher element, according to some embodiments of the present invention. [Figure 20-1] 20A-B are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 19E with an enlarged view of a distal portion of the system after the device has been withdrawn from the tissue, according to some embodiments of the present invention. [Figure 20-2] 20C-D are a side cross-sectional view, a top view, and a side view of the system shown in FIG. 19E with an enlarged view of a distal portion of the system after the device has been withdrawn from the tissue, according to some embodiments of the present invention. [Figure 20-3] 20E-G are a side cross-sectional view of the system shown in FIG. 19E, a close-up view of a distal portion of the system shown in FIG. 19F, and a top view of the system, according to some embodiments of the present invention. [Figure 21] 21A-D are a side cross-sectional view, a top view, and a side view of the system shown in 20A with an enlarged view of a distal portion of the system after deployment of a second anchor through tissue, according to some embodiments of the present invention. [Figure 22] 22A-C are side cross-sectional views of the system shown in FIG. 21A with an enlarged view of a distal portion of the system after the distal end of the device has been withdrawn from the tissue, according to some embodiments of the present invention. [Figure 23-1]23A-B are corresponding front and side views of an exemplary anchor after attachment to tissue, prior to cinching of the suture material, according to some embodiments of the present invention. FIG. 23C is a corresponding side view of the anchor shown in FIG. 23A after cinching of the small suture loop, according to some embodiments of the present invention. [Figure 23-2] Figure 23D is a corresponding front view of the anchor shown in Figure 23A after cinching a small suture loop, and Figures 23E-G are corresponding side, rear, and perspective views of the anchor shown in Figure 23D after cinching a large suture loop, according to some embodiments of the present invention. [Figure 24] 1A-1C are schematic diagrams of an exemplary method of delivering multiple anchors into tissue of a patient, according to some embodiments of the present invention. [Diagram 25] 1A-1C are schematic diagrams of an exemplary method of operation of a device for deploying multiple anchors, according to some embodiments of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0052] The present invention, in some embodiments thereof, relates to soft tissue repair systems and, more particularly but not exclusively, to multiple anchor delivery systems.

[0053] Disclosed herein is a multiple anchor delivery system and method that is particularly useful for repairing soft tissues such as the meniscus, but is not limited to this particular surgical procedure. One aspect of some embodiments of the present invention relates to deploying multiple anchors using a sheath. In some embodiments of the present invention, two anchors are sequentially deployed from a sheath by a single pusher element, with one anchor contacting the pusher element and a second anchor loaded into the sheath and positioned to the side of the pusher element. Optionally, the second anchor is mounted on and / or around the pusher element.

[0054] In some embodiments of the invention, retraction of the pusher element after deployment of the first anchor repositions the second anchor relative to the pusher element such that subsequent distal advancement of the pusher element deploys the second anchor from the sheath.

[0055] In some embodiments of the invention, as the pusher element is retracted proximally, the second anchor is retracted with the pusher element until the second anchor encounters an interfering feature preventing further retraction. In this manner, the pusher element is moved distally relative to the second anchor.

[0056] Exemplary embodiments of the present invention include systems and methods for deploying multiple anchors through a patient's tissue. The systems and methods are utilized, for example, in repairing torn meniscus tissue, by deploying first and second anchors through a torn tissue portion and optionally clamping the anchors against the tissue portion, thereby potentially holding the separated tissue portions together so that they may be repaired together. According to some embodiments, the system comprises a device including a sheath having a passage extending therethrough. A pusher element is disposed within the passage and is displaceable distally and proximally relative to the sheath.

[0057] An aspect of some embodiments of the invention relates to deploying first and second implants in the form of anchors from a sheath, the first and second anchors being sized and shaped to be positioned entirely within a passageway of the sheath, the first anchor being positioned distally relative to the pusher element and the second anchor being positioned proximally relative to the first anchor. Optionally, the first and second anchors are fully contained within the sheath prior to deployment of the anchors.

[0058] A length of suture material may extend through the first and second anchors to form a small loop and a large loop extending between the anchors. The small loop can extend from approximately the distal end of the first anchor to approximately the proximal end of the second anchor, and the free end can extend proximally through the device from approximately the proximal end of the first anchor.

[0059] An aspect of some embodiments of the invention relates to deploying multiple anchors utilizing a sheath with a lateral opening, e.g., a slot, at a distal end portion thereof, the slot being wide enough to allow a small suture loop and a large suture loop to pass therethrough. Optionally, a second anchor is positioned proximal to the lateral opening prior to deployment of the second anchor.

[0060] The device may include a tubular suture holder for holding the suture material within a limited distance from the needle, thereby potentially preventing entanglement of the suture material as the anchor moves through the passageway.

[0061] According to some embodiments of the invention, the pusher element may be displaceable by linear displacement of a drive mechanism. The drive mechanism may be displaceable by linear displacement of an actuator in the form of a trigger button. Alternatively, in some embodiments, the drive mechanism may be displaceable by rotation of a roller.

[0062] The actuator is movable in a distal and proximal direction and is coupled to a drive mechanism that is coupled to the pusher element, the coupling being arranged such that distal movement of the actuator results in proximal displacement of the drive mechanism and proximal movement of the actuator results in distal displacement of the drive mechanism.

[0063] The sheath may be inserted through tissue, such as a torn meniscus, for example. The sheath should be inserted through the tissue such that the distal end of the sheath exits the tissue before deployment of the anchors occurs.

[0064] Once in place through the tissue, the device is actuated by moving the actuator proximally, displacable the pusher element distally through the sheath such that the pusher element contacts the first anchor, and the amount of displacement of the pusher element is sufficient to deploy the first anchor from the sheath.

[0065] A barrier is disposed within the passageway proximal to the second anchor, the barrier optionally being in the form of a constriction of the passageway to prevent proximal displacement of the second anchor. The position of the second anchor within the sheath may or may not be affected by distal or proximal movement of the pusher, depending on the position of the second anchor relative to the barrier and the direction of movement of the pusher element.

[0066] After the first anchor is deployed, the pusher element is displaceable proximally through the passage to a location proximal to at least a portion of the second anchor. As the pusher element moves proximally, the second anchor can also be prevented from moving proximally upon contacting a barrier in the passage.

[0067] The needle may be removed from the tissue and reinserted through the tissue at another location where it is desired to deploy a second anchor. When the device is actuated by again moving the actuator in a proximal direction, the pusher element can then be displaced distally through the sheath into contact with the second anchor, the amount of displacement of the pusher element being sufficient to deploy the second anchor from the sheath.

[0068] After the second anchor is deployed, the suture loop is tightened to clamp the anchor against the tissue. The anchor in place can hold the torn tissue sections together so that the torn tissue sections can heal.

[0069] An aspect of some embodiments of the invention relates to deploying a first and a second anchor from a sheath, where the first anchor may be solid and the second anchor may be hollow. A pusher element is displaced proximally and distally within the sheath, where the pusher element is insertable through the second anchor. After deployment of the first anchor, proximal displacement of the pusher element is effective to move the pusher element to a proximal position of the second anchor, where the second anchor is effectively loaded and ready for deployment. Upon subsequent distal displacement of the pusher element, a distal end of the pusher element contacts a proximal portion of the second anchor, deploying the second anchor from the sheath. The pusher element optionally has a distal end that is wider than a proximal end of the second anchor, where the distal end of the pusher element is optionally compressed when inserted through the second anchor. The second anchor optionally has a compressible portion that is decompressed upon retraction of the pusher element to a position proximal to the second anchor.

[0070] An aspect of some embodiments of the invention relates to deploying a first and second anchor from a sheath, where the second anchor may be solid and optionally compressible. Optionally, the second anchor is laterally compressible. The second anchor may be compressed by the pusher element to be disposed along the pusher element. When the pusher element is retracted, the pusher element may slide past the second anchor to position the second anchor distally relative to the pusher element. The second anchor may then be deployed by distal displacement of the pusher element. Optionally, the second anchor is compressible and has an outer diameter equal to or greater than the inner diameter of the sheath when depressurized. In some embodiments, at least one of the first and second anchors may be hollow along at least a portion of its length, where the anchor is radially compressed by the sheath until deployed from the sheath by the pusher element.

[0071] An aspect of some embodiments of the invention relates to a system and method for deploying a first and a second anchor, where the pusher element includes a recess for holding the second anchor. Optionally, the recess may be a notch sized and shaped to temporarily accommodate the second anchor. Optionally, the second anchor may be positioned within the recess such that it is at least mostly surrounded by the pusher element. Optionally, the second anchor may be positioned within the recess such that it is surrounded on at least three sides by the pusher element. After deployment of the first anchor, the pusher element is retracted, which is effective to position the second anchor distally relative to the pusher element. The second anchor may then be deployed by distal displacement of the pusher element.

[0072] An aspect of some embodiments of the invention relates to deploying multiple anchors, where first and second anchors are deployed by respective pusher elements, optionally operating in parallel within a single sheath.

[0073] According to some embodiments, the system can include an actuator displaceable in a proximal direction to deploy a first anchor. Optionally, the actuator can be a trigger button, which can be linearly displaceable. Alternatively, the actuator can be a roller, which can be rotatable. In embodiments, there is a potential advantage that the user's finger moves in a first direction and the anchor is deployed in a second direction opposite the first direction. For example, the user can actuate the device by movement of a trigger button in a proximal direction, which results in deployment of the anchor in a distal direction out of the sheath.

[0074] In some embodiments, the system can include a locking mechanism to prevent inadvertent or premature deployment of the anchors.

[0075] An aspect of some embodiments of the invention relates to deploying multiple anchors using a sheath that includes an opening, e.g., a slot, at its distal portion. Suture portions provided on or through the anchors can extend out of the opening, thereby potentially preventing entanglement of the suture portions. Optionally, at least a portion of a second anchor is disposed proximal to the opening. Optionally, the entire length of the second anchor is disposed proximal to the opening.

[0076] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of components and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.

[0077] Potential benefits Systems and / or methods according to some embodiments of the present invention may provide one or more of several potential advantages not realized by the prior art. For example, as discussed herein, the provision of a trigger button / roller may provide easy one-handed actuation of the system with simple mechanical components. In addition, the amount of force required to be exerted on the trigger button / roller is substantially the same as the amount of force with which each anchor is deployed. This allows the user to control the deployment of the anchors, which is not possible with some prior art devices, such as devices where the deployment of the anchors is by a spring-loaded mechanism.

[0078] Additionally, providing a system where movement of a user's finger in a first direction results in displacement of a pusher element in a second direction, along with providing a safety latch / lock, for example, as described herein, can prevent premature / inadvertent deployment of the anchor.

[0079] Additionally, the ergonomic shape of the handle allows the needle to be more easily maneuverable through tissue, which can result in more accurate positioning of the anchor after deployment. Also, the ergonomic shape and operation of the handle and actuation mechanism in the form of a trigger button or roller, along with an engagable pusher drive unit, require less pressure to deploy the anchor as compared to prior art devices.

[0080] Additionally, having a slot in the needle through which the loop extends can facilitate deployment of the anchor as the loop / suture does not impede movement of the anchor through the passageway, and having a slot through which the loop extends can prevent tangling of the suture material as the anchor is deployed from the needle.

[0081] Additionally, as with any device that is inserted into the human body, there is a limited amount of space to operate within. Having a pusher element that is inserted through the second anchor can conserve space within the device.

[0082] Additionally, by providing a bobbin about which the suture material is wound, entanglement of the suture material within the housing can be prevented.

[0083] These and other potential advantages will be apparent to those of skill in the art.

[0084] These and other aspects of several embodiments of the invention are described herein with reference to the accompanying drawings.

[0085] Reference is now made to FIG. 1, which is a simplified cross-sectional view of a multiple anchor delivery system with an enlarged view of its distal end shown in an initial actuated orientation.

[0086] A system for delivery of multiple anchors, according to some embodiments, is shown in Figures 1-4. The system shown includes a passage therethrough, a pusher element displaceable within the passage, and a sheath having first and second anchors displaceable by the pusher element along the passage and deployable from the passage.

[0087] 1 , a multiple anchor delivery system according to some embodiments can be seen to optionally include a handle mechanism 102 and a delivery assembly, which in the illustrated embodiment is a needle assembly 104 connected to the handle mechanism 102. The needle assembly 104 has a distal end 106 and a proximal end 108 connected to the handle mechanism 102. The handle mechanism 102 and the needle assembly 104 are optionally disposed along a common longitudinal axis 109.

[0088] Handle mechanism 102 has a housing 110, which is optionally made from plastic by injection molding. Housing 110 defines a handle that may be graspable by a user and is configured to contain mechanisms responsible for transporting an anchor through needle assembly 104.

[0089] 1, according to the embodiment shown, trigger button 112 resides partially within housing 110, while trigger button 112 can be seen to have a gripping portion 114 for use with a user's finger and an elongated toothed portion 116 for interacting with pinion 118. Optionally, a distally extending protrusion 119 defining a shoulder may be formed on the distal end of toothed portion 116. Alternatively, in some embodiments, a proximally extending protrusion defining a shoulder may be formed on the distal end of toothed portion 116.

[0090] The pinion 118 also interacts with a rack 120. The rack 120 optionally has a first wall, optionally including a plurality of recesses 122, for interacting with an optional leaf spring 124. The rack 120 further has a second wall, which is configured to slidably mount a support element 126 thereon. The rack 120 optionally has a protrusion 127 configured to fixedly connect to a pusher element 130 configured to displace an anchor across the needle assembly 104. It is understood that the pusher element 130 is optionally solid, and optionally made of stainless steel. Optionally, the pusher element 130 is not solid, and can optionally be made of other materials.

[0091] It will be appreciated that the rack 120 may optionally be disposed parallel to and spaced apart from the elongated toothed portion 116 of the trigger button 112 .

[0092] In FIG. 1, it can be seen that the support element 126 is optionally slidably coupled to a pusher element 130 .

[0093] The support hub 131 is optionally formed within the housing 110 of the handle mechanism 102 .

[0094] Needle depth limiter 132 is optionally connected to support hub 131. Needle depth limiter 132 optionally includes a hub portion 134 rigidly coupled to housing 110 and an elongated hollow cannula 136 extending along longitudinal axis 109.

[0095] 1 further shows that an optional flexible safety latch 140 is coupled to and extends proximate to the support hub 131. In this initial operative orientation, it can be seen that the safety latch 140 optionally rests against a shoulder formed by the projection 119.

[0096] The needle assembly 104 includes a hollow needle 150 having a proximal end 152 and a distal sharp end 154. The hollow needle 150 also defines an interior surface 156 and an interior volume 158. It is understood that the hollow needle 150 is optionally made from stainless steel.

[0097] 1, it can be seen that pusher 130 is positioned within an interior volume 158 of needle 150 and extends distally from proximal end 152 toward distal end 154 of needle 150. Pusher 130 optionally defines a distally facing end surface 159.

[0098] An anchor stopper 160 is optionally disposed within the interior volume 158 of the needle 150 at a proximal portion of the needle 150 and optionally defines a distally-facing surface 162 .

[0099] A particular feature of some embodiments of the present invention is that the first anchor 170 is optionally solid and disposed within the interior volume 158 of the needle 150 distally relative to the pusher 130. It is seen that the first anchor 170 has a proximal end 172 and a distal end 174, the proximal end 172 being able to abut the distally facing end surface 159 of the pusher 130 in this initial actuation orientation. It is noted that the first anchor is optionally soft, made of polyethylene or polypropylene. It is understood that alternatively the anchor may be rigid. It is further noted that the first anchor 170 may be bioabsorbable.

[0100] A further particular feature of some embodiments of the present invention is that a second anchor 180 is disposed proximally relative to the first anchor 170, the second anchor being optionally tubular and defining an inner surface 182. It is noted that the second anchor is optionally soft, made of polyethylene or polypropylene. It is understood that alternatively, the anchor may be rigid. It is further noted that the second anchor 180 may be bioabsorbable.

[0101] The second anchor 180 is threaded over the pusher 130 such that an inner surface 182 of the second anchor engages an outer surface of the pusher 130. The second anchor 180 has a proximal end 184 and a distal end 186. The proximal end 184 of the second anchor 180 is optionally disposed near or abuts the distally-facing surface 162 of the anchor stop 160. The distal end 186 of the second anchor 180 is disposed distally relative to the proximal end 172 of the first anchor 170. Alternatively, in some embodiments, the distal end 186 of the second anchor 180 is disposed proximal to the proximal end 172 of the first anchor 170, for example, as shown in FIG. 1 .

[0102] It can be seen that the distal end of elongated hollow cannula 136 of needle depth limiter 132 is disposed proximal to the distal sharp end 154 of hollow needle 150. Because the outer diameter of cannula 136 is substantially larger than the outer diameter of hollow needle 150, the penetration depth of needle 150 into the patient's tissue is limited to the extent that the needle protrudes distally relative to the distal end of cannula 136.

[0103] 1, in this initial operating orientation, the trigger button 112 is disposed in a middle position in which the rack 120 is also disposed in a middle position in which the leaf spring 124 is seated within one of the recesses 122 formed in the rack 120.

[0104] A particular feature of some embodiments of the present invention is that actuation of trigger button 112 optionally affects the displacement of pusher 130 in the following manner: a user places a finger on gripping portion 114 and displaces trigger button 112 proximally, causing elongated toothed portion 116 of trigger button 112 to actuate pinion 118, which displaces rack 120 distally due to the interaction of rack 120 with pinion 118. Because pusher 130 is connected to rack 120, pusher 130 is also displaced distally.

[0105] During displacement of the rack 120, the leaf spring 124 is positioned within a subsequent one of the recesses 122, thereby potentially providing a tactile indication to the user that the trigger button 112 is positioned in a different one of its operating orientations.

[0106] A further special feature of some embodiments of the present invention is that in this initial operating orientation, safety latch 140 rests against a shoulder formed by protrusion 119 of trigger button 112, preventing distal displacement of trigger button 112. This is a safety feature intended to prevent inadvertent deployment of anchors from system 100. In this initial operating orientation, trigger button 112 can only be displaced in a proximal direction, which is not intuitive to a user.

[0107] 1 , in this initial operating orientation, first anchor 170 is optionally disposed near distal sharp end 154 of hollow needle 150, while proximal end 172 of first anchor 170 optionally abuts distally-facing end face 159 of pusher 130. Second anchor 180 is spaced proximally from first anchor 170 in this initial operating orientation and is threaded over an outer surface of pusher 130. Proximal end 184 of second anchor 180 is optionally spaced slightly distally from distally-facing surface 162 of anchor stopper 160.

[0108] Reference is now made to FIG. 2, which is a simplified cross-sectional view of multiple anchor delivery system 100 with an enlarged view of its distal end shown in a first anchor deployment operational orientation.

[0109] 2, in this first anchor deployment orientation, it can be seen that the trigger button 112 is disposed in a proximal position, while the rack 120 is disposed in a distal position and the leaf spring 124 is seated in another one of the recesses 122 formed in the rack 120.

[0110] The user displaces trigger button 112 proximally, thereby actuating elongated toothed portion 116 of trigger button 112 to actuate pinion 118, which in turn displaces rack 120 distally due to interaction between rack 120 and pinion 118. Because pusher 130 is connected to rack 120, pusher 130 is also displaced distally thereby.

[0111] During displacement of the rack 120, the leaf spring 124 is positioned within a subsequent one of the recesses 122, thereby potentially providing a tactile indication to the user that the trigger button 112 is now positioned in the proximal position.

[0112] A further special feature of some embodiments of the present invention is that in this first anchor deployment operating orientation, the safety latch 140 disengages from the shoulder formed by the protrusion 119 of the trigger button 112 and therefore no longer impedes distal displacement of the trigger button 112. In this first anchor deployment operating orientation, the trigger button 112 can be displaced in both the proximal and distal directions.

[0113] 2, in this first anchor deployment operational orientation, the first anchor 170 is optionally disposed distally relative to the distal sharp end 154 of the hollow needle 150, while the proximal end 172 of the first anchor 170 optionally abuts the distally-facing end surface 159 of the pusher 130. The first anchor 170 is now deployed from the interior volume 158 of the hollow needle 150 into the patient's tissue. The second anchor 180 is, in this first anchor deployment operational orientation, spaced proximally from the first anchor 170 and still threaded over the outer surface of the pusher 130. The proximal end 184 of the second anchor 180 is optionally spaced distally from the distally-facing surface 162 of the anchor stopper 160 than in the initial operational orientation.

[0114] Reference is now made to FIG. 3, which is a simplified cross-sectional view of multiple anchor delivery system 100 with an enlarged view of its distal end shown in a retraction orientation.

[0115] 3, in this retracted orientation, the trigger button 112 is disposed in a distal position. In this position, the rack 120 is disposed in a proximal position, with the leaf spring 124 seated within yet another one of the recesses 122 formed in the rack 120.

[0116] The user displaces trigger button 112 distally, causing elongated toothed portion 116 of trigger button 112 to actuate pinion 118, which in turn displaces rack 120 proximally due to interaction between rack 120 and pinion 118. Because pusher 130 is connected to rack 120, pusher 130 is also retracted proximally.

[0117] During displacement of the rack 120, the leaf spring 124 is positioned within a subsequent one of the recesses 122, thereby potentially providing a tactile indication to the user that the trigger button 112 is now positioned in a distal position. Alternatively, in some embodiments, proximal movement of the rack 120 from the position of FIG. 2 to the position of FIG. 3 results in the leaf spring being repositioned from being within the rightmost recess 122 (FIG. 2) to being within the leftmost recess 122 (FIG. 3).

[0118] A further special feature of some embodiments of the present invention is that in this retracted orientation, the safety latch 140 remains disengaged from the shoulder formed by the protrusion 119 of the trigger button 112 and therefore no longer impedes distal displacement of the trigger button 112.

[0119] As shown in FIG. 3, in this retraction orientation, the first anchor 170 remains deployed outside of the hollow needle 150.

[0120] A particular feature of some embodiments of the present invention is that during proximal retraction of pusher 130, second anchor 180 is released from pusher 130 and is no longer attached across pusher 130, but rather, proximal end 184 of second anchor 180 abuts and is supported against distally-facing surface 162 of anchor stop 160 in this retraction orientation, thus preventing proximal displacement of second anchor 180.

[0121] In FIG. 3, it can be seen that distally-facing end face 159 of pusher 130 is spaced proximally from proximal end 184 of second anchor 180 .

[0122] In this retracting orientation, pusher 130 is ready to deploy second anchor 180 in a manner similar to the deployment of first anchor 170.

[0123] It should be noted that additional elements, such as, for example, hooks, may be formed on the distal end of pusher 130 to confirm the release of second anchor 180 from the outer surface of pusher 130 and its loading for deployment into the patient's tissue.

[0124] Reference is now made to FIG. 4, which is a simplified cross-sectional view of multiple anchor delivery system 100 shown in a second anchor deployment operational orientation and an enlarged view of its distal end.

[0125] 4, in this second anchor deployment orientation, the trigger button 112 is again seen to be disposed in a proximal position, similar to the position shown in FIG 2. In this position, the rack 120 is disposed in a distal position, with the leaf spring 124 seated in another one of the recesses 122 formed in the rack 120.

[0126] A user displaces trigger button 112 proximally, causing elongated toothed portion 116 of trigger button 112 to actuate pinion 118, which in turn displaces rack 120 distally due to interaction between rack 120 and pinion 118. Because pusher 130 is connected to rack 120, pusher 130 is also displaced distally thereby.

[0127] During displacement of the rack 120, the leaf spring 124 is positioned within a subsequent one of the recesses 122, thereby potentially providing a tactile indication to the user that the trigger button 112 is now positioned in the proximal position.

[0128] Alternatively, in some embodiments, proximal movement of the rack 120 from the position of FIG. 3 to the position of FIG. 4 causes the leaf spring to be repositioned from within the leftmost recess 122 (FIG. 3) into the rightmost recess 122 (FIG. 4).

[0129] The safety latch 140 remains disengaged from the shoulder formed by the protrusion 119 of the trigger button 112, thus allowing the trigger button 112 to be displaced both proximally and distally.

[0130] 4, in this second anchor deployment operating orientation, second anchor 180 is pushed distally due to distal displacement of pusher 130 and engagement of distally-facing end face 159 of pusher 130 with proximal end 184 of second anchor 180. Second anchor 180 is now positioned distally relative to distal sharp end 154 of hollow needle 150 and is deployed from interior volume 158 of hollow needle 150 and into the patient's tissue.

[0131] A particular feature of some embodiments of the present invention is that a method of transferring multiple anchors into patient tissue optionally includes transferring system 100 to a desired surgical location, displacing trigger button 112 in a first direction to deploy a first anchor 170, followed by displacing trigger button 112 in a second direction opposite the first direction to load a second anchor 180, followed by another displacement of trigger button 112 in the first direction to deploy second anchor 180. In some embodiments, the first direction is a proximal direction and the second direction is a distal direction.

[0132] It should be noted that while the trigger button 112 described with reference to Figures 1-4 is linearly displaced, other types of trigger buttons can be used such that they can alternatively be rotated to advance or retract the pusher, thereby optionally affecting deployment of the anchors. Exemplary rotation triggers are further described herein with reference to Figures 5-23E.

[0133] System 100 may indicate to the user that second anchor 180 is loaded and ready to be deployed.

[0134] Alternatively, it is understood that system 100 can deploy first anchor 100, after which second anchor 180, initially positioned from interior volume 158 of needle 150 during retraction of the pusher, is loaded into pusher 130 and is now ready for deployment. For example, needle 250 may include a recess on its inner surface, and second anchor 280 may be pushed into the recess before or after pusher element 230 is retracted to its proximal-most position.

[0135] Further alternatively, both first anchor 170 and second anchor 180 may be loaded together in parallel, each of the anchors optionally covered by an elastic cover, and both anchors are loaded together into a single hollow needle 150 and a drive assembly having a first pusher that deploys first anchor 170 and a second pusher that deploys second anchor 180.

[0136] It should be noted that system 100 is optionally configured to be disposable. After use, the device may be disposed of in a municipally approved waste container.

[0137] It is noted that the trigger button 112 described with reference to Figures 1-4 is linearly displaced. However, another type of trigger button can be used, for example a roller 212 that can be rotated to advance or retract the pusher, thereby optionally affecting deployment of the anchor. An exemplary rotation trigger is further described herein with reference to Figures 5-23E.

[0138] Some exemplary embodiments 5, an exemplary multiple anchor delivery system 200 is shown in accordance with some embodiments of the present invention. The system includes a multiple anchor delivery device 204, which includes a handle 202, a cannula 236, and a sheath 250.

[0139] 6, an exploded view of the system 200 shown in FIG. 5 is shown in which some aspects of some components of the system can be more clearly seen. The handle 202 is shown having a housing 210 having a proximal end 213 and a distal end 215, the housing 210 including a right housing portion 210R and a left housing portion 210L. Components at least partially contained within the housing 210 include the roller 212, the rack 220, the bobbin 300, and the locking element 342. Also shown are the sheath 250, the pusher element 230, the optional suture holder 240, the cannula 236, and the delimiter 232, all of which are discussed further herein with respect to FIGS. 17A-22C.

[0140] 6 may be omitted or replaced by other components. For example, the suture holder 240 may be omitted and / or the rollers 212 and / or the rack 220 may be replaced with other components that are coupled together to drive the pusher element distally and proximally through the sheath.

[0141] Optionally, in some embodiments, the bobbin 300 may be replaced by another mechanism for storing the length of suture extending from the first anchor into the handle. Optionally, there is no mechanism for storing a length of suture, and the length of suture may be stored inside the housing 210 or may extend at least partially outside the housing.

[0142] 13A-D show an exemplary sheath 250 according to an embodiment of the present invention. It will be understood by those skilled in the art that "sheath" may be used as a general term to refer to an elongated component having a hollow lumen, e.g., a lumen having a circular or oval cross-section. The term "needle" is used generally to describe a component that is inserted into the human body. Thus, "needle" may include a "sheath" or other tube, and may optionally include a sharpened end, e.g., as discussed herein.

[0143] In the illustrated embodiment, the sheath 250 can be configured as a hollow needle having a circular cross section. The needle 250 has a proximal end 252 and a distal end 254 and can be made from stainless steel, for example, grade SS304, although other materials are possible. The needle 250 can have a length, for example, in the range of 176.3-176.7 mm; an outer diameter, for example, in the range of 1.8-2.55 mm; and an inner diameter, for example, in the range of 1.15-1.5 mm.

[0144] Distal end 254 is optionally provided with a sharpened tip 253 configured to penetrate tissue, such as, for example, a hypodermic needle. A portion of needle 250 adjacent distal end 254 may have a lateral opening formed therein, such as, for example, slot 255, optionally opposite the side having sharpened tip 253. The slot may have a length, for example, in the range of 29-30 mm, and a width, for example, in the range of 0.8-0.9 mm.

[0145] Slot 255 is optionally large enough to accommodate passage of suture loops 288a-b and free end 288c of the suture, e.g., as discussed further herein with respect to Figures, e.g., in connection with Figures 16a-c. Optionally, distal end 254 of needle 250 is provided with laser markings, e.g., of a type known in the art, which may be used as a reference to indicate the depth of insertion of needle 250 into tissue. Near the proximal end of the needle, a pair of recesses 257 may be provided. These and / or other optional features of the needle are discussed further herein.

[0146] In the illustrated embodiment, needle 250 is shown as having a straight configuration, however, it should be understood that needle distal end 254 may optionally and alternatively be curved as is known in the art. Needle 250 may have a curvature having a radius of curvature, e.g., in the range of 99-100 mm; a length, e.g., in the range of 20-22 mm; and a height, e.g., in the range of 2-3 mm.

[0147] Optionally, the needle is bendable, for example, which can prevent damage to tissue. Optionally, the needle can have two or more curves and / or curves in two or more planes. Those skilled in the art will appreciate that if the needle is curved, the pusher element optionally has sufficient thickness and flexibility to avoid buckling when displaced along the curved needle.

[0148] 14A-B show an exemplary pusher element 230 according to some embodiments of the present invention. The pusher element 230 may be generally configured as an elongated rod 320 having a proximal end 324 and a distal end 326. The pusher element 230 may have a length, for example, in the range of 197-197.2 mm, and an outer diameter, for example, in the range of 1.1-1.2 mm. The pusher element 230 is optionally made of stainless steel, for example, SS302 grade. However, other configurations and other materials for manufacturing the pusher element 230 are also contemplated. Optionally, the pusher element 230 has a circular cross-section, although other configurations, such as, for example, an elliptical shape, are also contemplated.

[0149] A pusher tip 322 may be provided at pusher proximal end 324, where tip 322 is optionally compressible. Optionally, pusher element 230 has an extension portion 323 at tip 322. Optionally, extension portion 323 may be compressible. The pusher element is optionally sufficiently flexible to resist buckling and to be able to transmit the force necessary to overcome friction between each of anchors 270 / 280 and inner surface 256 of needle 250. Optionally, inner surface 256 of needle is coated to reduce such friction.

[0150] According to some embodiments, the pusher element may be provided with a recess or notch for holding the second anchor therein. Optionally, the distal end of the pusher element and / or the second anchor may be compressible. As the pusher element is retracted, the second anchor is prevented from moving proximally by a barrier disposed in the passageway, e.g., a constriction of the passageway and / or a structural component that impedes proximal movement of the second anchor within the passageway, as discussed herein, for example with respect to FIG. 20A. As the pusher element is retracted, a portion of the pusher element distal to the recess slides over the second anchor such that the second anchor can be released from the recess of the pusher element. As a result, the distal end of the pusher element is proximal to the proximal end of the second anchor. The compressed distal end of the pusher element and / or the second anchor can then be decompressed such that the pusher element is wide enough to push the second anchor out of the needle, as discussed below, for example.

[0151] According to some embodiments, the sheath may be provided with a recess or notch for the second anchor, and the pusher element may slide past the second anchor as the first anchor is deployed. When the pusher element is retracted, it may release the second anchor from the recess in the needle by no longer blocking reduced pressure into the needle lumen, thereby potentially allowing the second anchor to be positioned for subsequent deployment.

[0152] 16A-C show an exemplary first anchor 270 having a proximal end 272 and a distal end 274, and an exemplary second anchor 280 having a proximal end 284 and a distal end 286. In the illustrated embodiment, the first anchor 270 is generally cylindrical and may be solid, while the second anchor 280 is generally cylindrical and may be hollow, for example, having an interior 281 bounded by an inner surface 282 of the second anchor 280. However, one of ordinary skill in the art will appreciate that, optionally, the anchors can have other configurations, for example, as discussed herein.

[0153] Each of the first anchor 270 and the second anchor 280 may be manufactured from 8-16 braided or woven strands of USP 4-0 or 2-0 fiber wire®, although other materials and / or sizes may be used, such as ultra-high molecular weight polyethylene (UHMWP), polyester polypropylene, or silicone elastomer coatings, optionally dyed using, for example, D&C Blue No. 6, D&C Green No. 6, and / or Logwood Black dyes, as known in the art.

[0154] Optionally, one or both of the anchors 270 and 280 may include a silicone elastomer coating. Each of the anchors 270 and 280 may have a length, for example, in the range of 11-13 mm, and an outer diameter, for example, in the range of 1.2-1.4 mm. The second anchor 280 may have an inner diameter, for example, in the range of 0.65-0.86 mm. A length of suture material 288 may extend through the anchors, and optionally has a small portion 288a that forms a small loop between the proximal end 272 of the first anchor and the distal end 286 of the second anchor, a larger portion 288b that forms a larger loop between the distal end 274 of the first anchor and the proximal end 284 of the second anchor, and a free end 288c that extends proximally from the proximal end of the first anchor. The length of suture material 288 may be formed of, for example, 2-0 fiber wire®, although other materials may optionally be used. Optionally, the small portion of suture material 288a is 50 mm long, the large portion of suture material 288b is 220 mm long, and the free end 288c of the suture is 300 mm long, although other lengths may be used.

[0155] One or both of first anchor 270 and second anchor 280 are optionally sufficiently soft and / or flexible so as not to cause damage to tissue or blood vessels near the implant. Optionally, either or both of first anchor 270 and second anchor 280 may be rigid. Optionally, either or both of first anchor 270 and second anchor 280 are bioabsorbable, optionally maintaining the mechanical strength of the anchor or anchors until tissue 206 has healed (e.g., 1-3 months).

[0156] For example, as discussed herein, according to some embodiments, optionally the first anchor may be a solid anchor having a blind hole at its proximal end into which the distal end of the pusher element may be inserted prior to deployment of the first anchor. In this embodiment, the distal end of the pusher element may not contact the proximal end of the first anchor as in the embodiment shown in FIG. 18A, but instead, the distal end of the pusher element may contact an end face of the blind hole in the first anchor.

[0157] According to a further alternative embodiment, first anchor 270 may be hollow and a pusher element may be disposed proximally relative to the first anchor, with the pusher element configured to contact a proximal end of the first anchor to deploy the first anchor. Optionally, or additionally, the pusher element may be disposed partially within an interior of the first hollow anchor, with the pusher element having a distal end configured to engage an inner surface of the first anchor, thereby potentially deploying the first anchor when the pusher element is moved distally.

[0158] In some embodiments of the invention, second anchor 188 may optionally be replaced with a compressible solid anchor, for example, as discussed herein with respect to Figures 16A-C.

[0159] In some embodiments, the anchor comprises a suture portion that allows the anchor to be fastened to tissue after deployment of the anchor. Optionally, the suture material is threaded at least partially through the interior of the second anchor 280. Optionally, the suture material may be threaded at least partially through the material of the first anchor 270 and / or the material of the second anchor 280.

[0160] Optionally, each of the first anchor 270 and the second anchor 280 can have a collar or channel (not shown) extending along an outer surface of the anchor, the channel configured to retain a portion of the suture material 288 therein. The anchors 270 and 280 can be positioned within the needle 250 such that the suture portions 288a-b and the free ends 288c of the sutures and / or the channel protrude from the needle slot 255.

[0161] It should be noted that, depending on the shape of the bore through hollow anchor 280 and the shape of the opening of the second anchor into the bore, second anchor 280 may be sufficiently flexible and distal end 324 of pusher element 230 may be sufficiently narrow to allow the pusher element to pass through interior 281 of second anchor 280. Additionally, distal end 324 of pusher element 230 may be sufficiently wide such that the pusher element pushes the second anchor distally after retracting from second anchor 280, as will be further described below.

[0162] 8A-E, a rack 220 is shown according to some embodiments of the present invention. For example, as will be further discussed with respect to the operation of system 200, rack 220 may be coupled to rollers to displace pusher element 230 through needle passageway 264. Rack 220 has a proximal end 224 and a distal end 226. An upper surface 221 of rack 220 may be provided with a plurality of evenly spaced teeth 225 extending along the length of the rack. In the illustrated embodiment, rack 220 is provided with two rows of teeth, however, as will be appreciated by one of ordinary skill in the art, optionally rack 220 may have a single row of teeth extending along at least a portion of its length.

[0163] According to some embodiments, the lower surface 223 of the rack 220 may include a recess near the proximal end 224 of the rack having distal and proximal surfaces 228a-b. The rack 220 may also include flexible strips 229 that appear as curved portions protruding from the sides of the rack. At the center of each strip 229 is a v-shaped protrusion 229a that extends away from the rack 220. The rack 220 may include a number of supports 218a-d extending from the sides of the rack 220, with supports 218a-b located at the distal end of the rack and supports 218c-d located near the proximal end of the rack. One or more of these elements may be described in more detail herein.

[0164] 9A-C, a number of exemplary rollers 212a-c are shown, according to some embodiments of the present invention. The rollers 212 are manually movable components that may be coupled to a rack 220 such that movement of the rollers actuates the rack to displace proximally or distally within the housing, for example, as discussed further with respect to the operation of the device. Each roller 212a-c may be of a generally circular configuration with a circular bore 381 disposed at its center. Each roller 212a-c optionally includes an actuating portion 380 on approximately half of its respective circumference 383a-c, the actuating portion 380 being defined by a number of optionally equally spaced teeth 382. The rollers 212a-c may also include respective gripping portions 384a-c on approximately the remaining half of the roller's circumference. In some embodiments (FIGS. 9A-B), the gripping portions 384a-b may include a number of evenly spaced teeth 386a-b similar to the teeth of the actuating portion 382. However, gripping portion 384c may alternatively include fewer teeth, such as, for example, only three teeth 386c (FIG. 9C) optionally evenly spaced along gripping portion 384. Note that working portion teeth 382 are optionally configured to be engagable with corresponding teeth 225 of rack 220 (FIG. 8A).

[0165] Roller 212c may optionally be provided with a peg 392 that protrudes from a surface 391 of rollers 212a-c, which may be used to position the roller within the housing.

[0166] Rollers 212a-c may optionally be provided with position markings 390a-c to indicate the rotational position of the rollers to a user. For example, as shown in FIG. 9B, roller 212b may have position markings "1", "2", and "3". Optionally, rollers 212a-c may be provided with markings 390D-NR to indicate, for example, their respective deployed, neutral, and retracted positions, or any other markings to indicate the position of the rollers to a user. Optionally, electronic circuitry may be provided to indicate the current position of roller 212 to a user.

[0167] 15D-E, an exemplary cannula 236 is shown according to some embodiments of the present invention. Cannula 236 may be manufactured from PTFE and has a length, for example, in the range of 135-137 mm; an outer diameter, for example, in the range of 3.5-3.6 mm; and an inner diameter, for example, in the range of 3.3-3.4 mm.

[0168] A cannula 236 is disposed over the needle, if present, and over the suture holder. The distal end 235 of the cannula can be moved relative to the distal end 254 of the needle to adjust the length of the needle extending from the cannula, as will be described further herein with respect to delimiter 360. Note that the inner diameter of the cannula 236 must be larger than the outer diameter of the needle 250 so that the needle 250 can be inserted into the cannula 236, and, if necessary, have the suture holder 240 between the inner surface of the cannula and the outer surface of the needle.

[0169] 15A-C show an exemplary suture holder 240, according to some embodiments of the present invention. The suture holder 240 is optionally utilized to hold the suture loops 288a-b adjacent to the needle 250, allowing the anchors to be displaced inside the needle 250, optionally preventing entanglement of the suture material. After the anchors 270 and 280 (FIGS. 16A-C) are inserted into the needle 250 and the suture loops 288a-b extend through the slots 255, the suture holder 240 can be placed over the needle to hold the suture therein. Optionally, the suture holder 240 can be omitted from the system 200.

[0170] Suture holder 240 is configured as a generally cylindrical tube having a distal end 242 and a proximal end 244. Suture holder 240 may be made from PTFE and may have a length, for example, in the range of 130-132 mm; an inner diameter, for example, in the range of 2.6-2.8 mm; and an outer diameter, for example, in the range of 3.0-3.2 mm; with the cut-out portion extending 5-6 mm from the proximal end 244 of the suture holder.

[0171] At its proximal end 244, the suture holder has a notched portion such that the proximal end comprises a semicircular arm 243 having a horizontal edge 245. Edge 245 intersects with vertical edge 241 at a right angle. Suture holder 240 is discussed further herein with respect to assembly of the components of system 200.

[0172] It should be noted that the inner diameter of the suture holder 240 must be larger than the outer diameter of the needle 250 so that the needle 250 can be inserted into the cannula 236. Additionally, the inner diameter of the suture holder must be large enough so that there is sufficient space between the inner surface of the suture holder and the outer surface of the needle for the presence of the suture loops 288a-b. With reference to FIGS. 11A-D, an exemplary locking element 342 is shown that may be provided as part of an optional locking mechanism 340 according to an embodiment of the present invention, which will be discussed further herein. The locking element 342 may have a generally circular body 343 having a generally circular opening 344. A locking bar 346 configured as a long arm and a short arm 348 may extend from the circular body 343. A peg 350 may protrude from a surface of the locking bar 346, which is formed during the manufacture of the locking element 324. The locking element 342 is further described herein with respect to FIGS. 17A-22C.

[0173] 12A-E show an exemplary needle length delimiter 360 according to an embodiment of the present invention. The delimiter 360 may include a hub 362 and a circular collar 364. A pair of arms 361 extend from the hub 362 away from the collar 364. A slider 366 may extend proximally from the hub 362, the slider having an index peg 368 thereon. The delimiter 360 is further described herein with respect to assembly of the system 200. The delimiter 360 may be manufactured from any suitable material, such as, for example, polytetrafluoroethylene (PTFE). Optionally, the delimiter 360 may be omitted from the system 200.

[0174] 10A-D show an exemplary bobbin 300, according to some embodiments of the present invention. The bobbin 300 optionally includes a spool 302 bounded on either side by flanges 304. A bore 306 may extend through the spool 302. The spool 302 is provided with a rod 308 that extends through the spool. The rod optionally includes grooves 310 on both ends thereof. The bobbin is discussed further herein with respect to assembly of the system 200.

[0175] 7A-E, further details of an exemplary right half portion 210R of housing 210 are shown, according to some embodiments of the present invention. Housing 210 may be manufactured from acrylonitrile butadiene styrene (ABS), although other materials are possible.

[0176] The inner wall 290 of the right housing portion 210R may be provided with a pair of parallel flanges, an upper flange 292a and a lower flange 292b, with projections 296a and 296b therebetween. The first recess 222a may be formed between the flanges 292a and 292b proximal to the projection 296a, the second recess 222b may be formed between the flanges 292a and 292b between the projections 296a and 296b, and the third recess 222c may be formed between the flanges 292a and 292b distal to the projection 296b. The inner wall 290 of the right housing portion 210R may also be provided with a roller mounting peg 299, locking element stops 295a and 295c, a bobbin holder 298, stops 293a-b, and a locking element peg 294. Note that stop 295a is configured as a curved portion that protrudes from the inner wall 290 of the housing, with a small knob 295b at its upper end. Near the distal end 215 of the housing, a clamp bar 297 may be provided. These elements are described further herein with respect to the assembly and operation of system 200.

[0177] Those skilled in the art will appreciate that, optionally, the left housing portion (not shown) can be formed similarly to the right housing portion 210R, but with the components laterally reversed. The left and right housing portions 210L-R may be configured to snap-fit ​​together or otherwise joined, for example, by gluing or screwing together, to form the housing 210, as known in the art.

[0178] Housing 210 may be optionally manufactured from any suitable material, such as, for example, plastic, by injection molding. Housing 210 may be configured, for example, to contain, in part, mechanisms involved in transporting the anchor through tissue, as discussed herein with respect to assembly and operation of system 200.

[0179] Assembling the System Components According to some embodiments, system 200 may be assembled as follows: first, proximal end 326 of pusher element 230 may be inserted through distal end 286 of hollow anchor 280. Note that inner surface 282 of second anchor 280 may or may not engage with the outer surface of pusher element 230.

[0180] The proximal end 326 of the pusher element is then inserted through the distal end 254 of the needle 250 until it extends from the proximal end 252 of the needle, and a hollow anchor may be positioned within the needle 250, optionally with the suture loops 288a-b positioned outside of the needle slot 255. A first anchor may then be inserted into the distal end 286 of the needle, optionally with the suture loops 288a-b positioned outside of the needle slot 255, with the free end 288c of the suture extending proximally within the needle. Optionally, for example, the small and large suture loops 288a-b may be adjusted to have desired measurements, as discussed herein with respect to FIGS. 16A-C. Optionally, as discussed herein, for example, the free end 288c of the suture can be twisted around the large suture loop 288b so that a knot can be formed after deployment of the anchors 270 and 280. Note that in this configuration, the first anchor 270 can be disposed distally relative to the distal end 324 of the pusher element, and the second anchor 280 can be disposed proximal to the proximal end 272 of the first anchor 270.

[0181] The proximal end 326 of the pusher element can then be inserted into the bore 227 of the rack 220 and attached thereto, for example by a set screw, to ensure that the needle is positioned with the slot on the same side of the rack 220 as the teeth 225.

[0182] The proximal end 252 of the needle may be inserted into the distal end 242 of the suture holder 240, and the suture holder may be threaded over the needle, optionally until almost all of the needle slot 255 extends beyond the distal end 242 of the suture holder. Optionally, about 2-3 mm of the needle slot 255 is covered by the suture holder 240.

[0183] Locking element 342 may be positioned relative to rack 220 such that locking bar 346 is disposed within recess 228 of rack 220. The rack and locking element are then positioned within one half of housing 210, such as housing right half 210R, with rack supports 218b and 218d disposed within recesses 222a and 222c, between housing flanges 292a and 292b, with small arm 348 on locking element 342 below stop 295a in housing 210, and the cannula disposed within hub 231 of the housing.

[0184] In some embodiments, at this point, suture holder 240 can be adjusted so that semicircular arm 243 is positioned inside the right portion of housing collar 231 of housing portion 210R and oriented so that the semicircular arm forms a complete circle with the right portion of collar 231, with vertical edge 241 of suture holder 240 abutting edge 233 of housing collar 231. This ensures that free end 288c of the suture passes through the circle formed by semicircular arm 243 and the right portion of housing collar 231, thereby potentially preventing possible accidental closure of housing portions 210L-R over free end 288c of the suture.

[0185] The free end 288c of the suture may optionally be threaded through bore 306 of bobbin 300, the suture may be wound around bobbin spool 302, and the bobbin may then be placed in housing portion 210R with bobbin rod 308 in holder 398 in right housing portion 210R. The portion of the free end 288c of the suture extending between the proximal end 237 of the cannula and the spool 302 should be positioned within housing hub 231. The bobbin can be optionally wound tighter, if necessary, by inserting a tool into groove 310 on the end of rod 308.

[0186] An opening 381 on roller mounting peg 299 in right housing portion 210R allows a roller, such as roller 212c, to be placed in right housing portion 210R with peg 392 on the exterior of right housing portion 210R to aid in positioning the roller relative to housing portion 210R. In this configuration, roller actuating portion 380 is optionally placed on the interior of right housing portion 210R and roller gripping portion 384c is optionally placed on the exterior of right housing portion 210R.

[0187] Next, left housing portion 210L can be snapped or otherwise attached to right housing portion 210 to form closed housing 210 with rack 220, locking element 342, and bobbin 300 on the inside and roller 212a partially inside and partially outside housing 210. Finally, distal end 254 of needle and distal end 235 of cannula are inserted through collar 364 of delimiter 360, and delimiter 360 can be advanced over cannula 236 with delimiter arm 361 inserted into an opening (not shown) in housing 210 and with delimiter indicator peg 368 adjacent marking 232 on housing 210 until the delimiter seats on housing hub 231. Cannula 236 can then be passed over distal end 254 of needle and suture holder 240. A proximal force can be applied to cannula 236 such that proximal end 237 of the cannula is inserted into delimiter collar 364 .

[0188] Those skilled in the art will appreciate that assembly of parts of system 200 can optionally be performed in a different order, with the final assembly being the same as that achieved according to the assembly procedures set forth above. Optionally, assembly of some of the components, such as locking elements, may be omitted.

[0189] System Operation Operation of system 200 will be described with reference to the system components mentioned above. It should be noted that the system has three operating positions, namely retracted, neutral, and advanced, and transitions between these operating positions are actuated in the illustrated embodiment, for example, by rotation of roller 212, as discussed below. In the retracted position, pusher element 230 is retracted to a proximal-most position within device 204. In the advanced position, pusher element 230 is advanced to its distal-most position within device 204, and can optionally extend partially outside the distal end of needle 250 of device 204. In the neutral position, pusher element 230 is disposed halfway between its retracted and advanced positions.

[0190] Reference is now made to FIGS. 17A-D, which illustrate an exemplary multiple anchor delivery system 200 in an initial operational orientation, e.g., prior to deployment of anchors 270 and 280, according to some embodiments of the present invention. As discussed above, system 200 can include a handle 202 having a housing 210. Rack 220 can be positioned within the housing, with supports 218a-d (FIGS. 8A-E) supported between flanges 292a-b (FIGS. 7A-E) within housing 210. In the initial operational orientation, in some embodiments, rack 220 can be disposed in a neutral position, e.g., not advanced distally or retracted, such that projection 229a (FIGS. 8A-D) seats in central recess 222a (e.g., FIG. 7A) of housing 210.

[0191] As described above, pusher element 230 can be disposed within needle 250, and the pusher element can extend into housing 210 such that proximal end 326 of the pusher element is disposed and retained within bore 227 in distal end 226 (FIG. 8A) of rack 220. Needle 250 can be disposed within cannula 236, and proximal end 252 of the needle can be retained within housing 210 by clamp bar 297 (FIG. 7B) of housing 210 at recess 257 on needle 250 (FIGS. 13B-C).

[0192] Handle 202, pusher element 230, needle 250, and cannula 236 are optionally all disposed along a mutual longitudinal axis 209 (FIG. 17D).

[0193] The delimiter 360 may be disposed on the distal end 215 of the housing such that the delimiter hub 362 (FIG. 12A) seats on the housing hub 231 (FIG. 7A) and the cannula 236 is retained within a collar 364 of the needle delimiter 360. The delimiter slider 366 may be positioned adjacent to markings 232 on the housing 210 that may indicate the distance that the needle 250 protrudes from the cannula 236.

[0194] Distal movement of slider 366 optionally affects corresponding distal movement of cannula 236 relative to needle 250, which may cause cannula 236 to extend further over the needle, such that needle distal end 254 extends less from cannula distal end 235. Similarly, proximal movement of slider 366 optionally affects corresponding proximal movement of cannula relative to needle 250, which may cause cannula 236 to be partially withdrawn from over needle 250, such that more of needle distal end 254 may extend from cannula distal end 235. Note that the penetration depth of needle 250 into patient tissue 206 is optionally limited to the extent that the needle protrudes distally relative to cannula 236 distal end 235. This is optionally because the cannula has a blunt distal end and does not penetrate the tissue.

[0195] In the illustrated embodiment, system 200 includes roller 212c, although one of ordinary skill in the art will appreciate that any of the exemplary rollers 112a-c may be utilized in the devices discussed herein. However, for simplicity, in the following description, the roller will be designated by reference numeral 112, the gripping portion will be designated by 384, and the actuation portion will be designated by 380.

[0196] The roller 212 may be rotatably mounted on a roller mounting peg 299 (FIG. 7B) such that the roller 212 resides partially within the housing 210 and extends from an opening 211 in the housing 210. The roller 212 has a gripping portion 384 that is contacted by a user's fingers and an actuation portion 380 for interacting with the teeth 225 of the rack 220, as described above.

[0197] A particular feature of some embodiments of the invention is that in an initial operational orientation, a locking element 342 may be supported against rack 220, for example, as discussed below, which prevents proximal displacement of rack 220, and thereby potentially prevents displacement of roller 212 in a counterclockwise direction (toward distal end 254 of the needle). This can provide a safety feature that may prevent inadvertent or accidental deployment of anchor 270 or anchor 280 from system 200. In this initial operational orientation, roller 212 can optionally only move in a clockwise direction (away from distal end 254 of the needle), which may not be intuitive to a user, thereby potentially preventing inadvertent or accidental premature deployment of anchor 270 / 280.

[0198] The rack 220 is supported by supports 218a-d between flanges 292a-b (FIGS. 7A-B) of the housing inner wall 290, such that the rack 220 can slide along the lower flange 292b. Flexible strips 229 extend from the sides of the rack 220, as described above with respect to FIGS. 8A-D, such that a v-shaped projection 229a of the rack can project into any one of the recesses 222a-c of each housing portion 210L-R. In the configuration shown in FIG. 17A, the rack 220 can be positioned such that the projections 229a project into the recesses 222b on either side of the housing 220.

[0199] Teeth 225 of rack 220 can engage corresponding teeth 382 of roller 212 such that rotation of roller 212 in a clockwise direction affects movement of rack 220 in a distal direction. Conversely, counterclockwise rotation of roller 212 optionally affects movement of rack 220 in a proximal direction. Note that in the initial operating orientation, roller 212 may be in a neutral position, as indicated by mark 390N visible on roller 212 in FIG. 17D .

[0200] In the initial operational orientation shown, locking bar 346 of locking element 342 is inserted into a recess in rack 220 (FIG. 8D) and body 343 of locking element 342 is mounted on peg 294 (FIG. 7A) of housing 210 such that locking bar 346 extends vertically upward from body 343 and abuts surface 228b of recess 228 in rack 220. In the initial operational orientation shown, small arm 348 of locking element 342 is positioned below stop 295a (FIG. 7B) of housing 210.

[0201] In the illustrated embodiment, the system 200 may be provided with a first solid anchor 270 and a second hollow anchor 280, which may optionally be threaded through the suture material, as described above with respect to, for example, FIGS. 16A-C. In the illustrated initial operating orientation, the first anchor 270 may be positioned distal to the pusher element 230 within the needle 250, optionally adjacent the distal end 254 of the needle, and the second anchor 280 may be mounted on the pusher element. In the illustrated embodiment, the pusher element 230 extends through the second anchor 280. However, other embodiments are contemplated, such as, for example, c-shaped anchors, solid anchors, or other configurations, as discussed herein and understood by those skilled in the art. Optionally, the first anchor 270 may abut the distal end 324 of the pusher 230.

[0202] For example, according to the embodiment shown in FIG. 17B, the suture portions 288a-b may extend out from the anchors 270 and 280 through the needle slot 255. Note that the provision of the slot 255 allowing the suture portions 288a-b to extend out of the needle may prevent the loops 288a-b from impeding the movement of the anchors 270 and 280 through the needle. The free end 288c of the suture may extend proximally from the proximal end 272 of the first anchor 270 along the needle 250, inside the optional suture holder 240, and through the hub 231 of the housing 210. In embodiments in which the suture holder 240 is omitted, the free end 288c of the suture may extend proximally along the needle, inside the cannula 236, and through the housing hub 231. In the illustrated initial operating orientation, the free end 288c of the suture is threaded through bore 306 of the bobbin 300 (FIGS. 10A-D) and wound around the bobbin spool 302 before the bobbin 300 is attached to the housing 210, for example, as discussed herein with respect to FIGS. 7A-B. It will be understood by those skilled in the art that the free end 288c of the suture may alternatively be contained within the housing 210 without being wound around the bobbin 300, may be stored on another component within or outside the housing, or may extend at least partially outside the housing.

[0203] 17B shows the distal end 242 of the suture holder 240 in a position proximal to the distal end 235 of the cannula. The suture holder 240 can hold the loops 288a-b and a portion of the free end 288c of the suture adjacent the needle 250 within the suture holder. Optionally, in some embodiments, the suture holder 240 can have a length that is long enough such that its distal end 242 is closer to or generally flush with the distal end 235 of the cannula than as configured in FIG. 17B, thereby potentially holding a greater portion of the loops 288a-b and the free end 288c.

[0204] Prior to inserting needle distal end 254 through tissue 206, a probe, for example of a type known in the art, is optionally used to measure the thickness of tissue that the needle must penetrate. Slider 366 on delimiter 360 may be advanced or retracted, as desired, until indicator peg 368 indicates the length of needle distal end 254 that may be insertable through tissue 206. This causes cannula 236 to be correspondingly advanced or retracted over needle 250 such that the length of needle extending from the cannula is adjusted according to the measured thickness of tissue 206, as known in the art.

[0205] 18A-D, the distal end 254 of the needle can be inserted through the tissue 206, optionally with the aid of the sharpened tip 253 (FIG. 18C) of the needle 250. Due to the presence of the cannula 236, only the portion of the needle 250 protruding from the distal end 235 of the cannula may be inserted through the tissue 206, with the needle being inserted through the tissue 206 until the cannula 236 abuts the surface of the tissue 206.

[0206] Optionally, anchor 270 can close the distal tip 253 of the needle and the opening of needle slot 255 so that tissue does not collect in the opening. Optionally, first anchor 270 includes a beveled distal end having a shape corresponding to the shape of distal tip 253 of the needle.

[0207] Note that in this position, the first anchor 270 can be positioned at least partially through the tissue 206, however, the first anchor can optionally not yet be deployed from the needle 250 and still be positioned within the needle 250.

[0208] 19A-D, it is noted that according to some embodiments, the components of system 200 are designed to provide the system with the desired aspects described herein. For example, to rotate the roller, a user must displace gripping portion 384 a sufficient distance to cause rotational movement of the roller in the desired direction and to the desired degree of rotation, and move rack 220 in the desired direction and the desired distance. This latter movement also requires that protrusion 229a (FIGS. 8A-D) on rack 220 be moved over protrusions 296a and / or 296b (FIG. 7A) in housing 210.

[0209] Note that the amount of force required to rotate roller 212 in a clockwise direction from the neutral position (FIG. 17D) is optionally the same as the amount of force required to rotate roller 212 in a counterclockwise direction from the neutral position. Alternatively, if desired, the amount of force required to rotate roller 212 in a clockwise direction (to deploy anchor 270) can be greater than the amount of force required to rotate roller 212 in a counterclockwise direction (to retract pusher element 230), or vice versa.

[0210] Deployment of first anchor 270 may be actuated by rotating roller 212 in a clockwise direction from a neutral position (FIG. 18D), where markings 390N are visible on roller 212, to a deployed position (FIG. 19D), where markings 390D are visible on roller 212. This clockwise rotation of roller 212 optionally affects distal movement of rack 220, for example, by engagement of roller teeth 382 (FIGS. 9A-C) with teeth 225 (FIG. 8A) on rack 220, as discussed herein. This distal movement of rack 220 is accompanied by a corresponding distal movement of pusher element 230 attached to distal end 226 of the rack. As the rack 220 advances distally, the pusher element 230 is advanced distally to the distal end 254 of the adjacent needle, optionally past the distal end of the needle, pushing the first anchor 270 out of the needle 250 and through the tissue 206, as shown in FIGS. 19A-D.

[0211] Note that during deployment of the first anchor 270 , the proximal end 272 of the first anchor is distal to the second anchor 280 .

[0212] As mentioned above, clockwise rotation of roller 212 can optionally affect a corresponding movement of rack 220 in the distal direction. As rack 220 moves distally from the position shown in FIG. 18A to the position shown in FIG. 19A, supports 218a-d (FIGS. 8A-E) slide distally along housing flanges 292a-b (FIGS. 7A-B). Distal movement of rack 220 is sufficient to move v-shaped protrusion 229a on rack 220 from recess 222b, over protrusion 296, and into recess 222a on inner wall 290 of housing portions 210L-R. Additionally, movement of protrusion 229a over protrusion 296a can optionally cause an audible indication, such as, for example, a click, and / or a tactile indication, which informs the user that the first anchor has been deployed. Optionally and / or alternatively, electronic circuitry may be provided to indicate to a user that first anchor 270 has been deployed.

[0213] 19A-22C, the first and second anchors 270 / 280 are shown as straight elements for illustrative purposes only. Optionally, one of ordinary skill in the art will appreciate that once deployed, each of the anchors 270 / 280 may have a different configuration, e.g., curved, depending on the stiffness of the anchor and the amount of force applied to the anchor by the suture portions 288a-c extending through tissue 206.

[0214] As described above, as roller 212 rotates in a clockwise direction, rack 220 begins to move distally, for example from the position shown in FIG. 18A to the position shown in FIG. 19A. At the same time, locking element 342 begins to rotate in a counterclockwise direction as locking bar 346 is pushed out by surface 228b (FIG. 8D) of rack 220 as the rack moves distally. At the same time, minor arm 348 of locking element 342 begins to slide along stop 295a (FIG. 7B) in housing 210. As rack 220 continues to move distally, locking element 342 continues to rotate and minor arm 348 continues to slide along stop 295a as locking bar 364 moves down surface 228a of rack 220 and toward the opening of recess 228. When the rack 220 has moved distally enough so that the locking bar 364 is adjacent the opening of the recess 228, the small arm 348 abuts the knob 295b at the end of the stop 295a. Further movement of the rack 220 further compresses the locking bar 364 until it exits the recess 228. Optionally, at the same time, the small arm 348 is pushed over the knob 295b, producing a slight clicking noise. This slight clicking noise should not be confused with the clicking noise caused by the movement of the protrusion 229a of the rack over the protrusion 296a in the housing 210, as described above. The small arm 348 is now positioned between the knob 295b and the stop 295c and is therefore prevented from moving further. At this point, the locking element is disengaged from the rack 220. From this point on, the locking element 342 remains in this position regardless of the position of the rack 220.

[0215] 19D, distal end 226 of rack 220 abuts stop 293a on housing 210, preventing roller 212 from rotating further in the clockwise direction. Since rack 220 cannot move any further distally, teeth 225 of rack 220 engage teeth 382 of roller 212, preventing roller 212 from rotating further in the clockwise direction.

[0216] 19B , anchor stopper 260 can be disposed within interior volume 258 of needle 250, optionally at a proximal portion of needle 250. Anchor stopper 260 defines a distally-facing surface 262. Anchor stopper 260 defines a barrier within needle 250 where passageway 264 is narrowed, thereby potentially preventing possible proximal movement of second anchor 280 within the passageway. Proximal end 284 of second anchor 280 is optionally disposed near or abuts distally-facing surface 262 of anchor stopper 260. Alternatively, proximal end 284 of second anchor 280 is spaced slightly distally from distally-facing surface 262 of anchor stopper 260.

[0217] After deployment of first anchor 270, proximal end 284 of second anchor 280 is optionally spaced more distally from distally-facing surface 262 of anchor stopper 260 than in the initial operating orientation ( FIG. 17B ) because it was displaced distally by distal movement of the pusher element as the first anchor was deployed.

[0218] 19E-H, system 200 is shown in a retraction orientation. Roller 212 has been rotated counterclockwise from the position shown in FIG. 19D to the position shown in FIG. 19H, where markings 390R are visible on roller 212. This counterclockwise rotation of roller 212 optionally affects proximal movement of rack 220, for example, due to engagement of roller teeth 382 with teeth 225 on the rack, as discussed herein with reference to FIGS. 9A-C. This proximal movement of rack 220 is optionally accompanied by a corresponding proximal movement of pusher element 230 attached to distal end 226 of rack. As rack 220 moves proximally, pusher element 230 is retracted into needle 250.

[0219] Note that even when pusher element 230 is in its most retracted position, proximal end 326 of the pusher element remains within housing 210. Optionally, or alternatively, pusher element 230 may extend proximally from the housing, for example, up to or more than 5 cm.

[0220] As discussed above, counterclockwise rotation of roller 212 optionally affects corresponding movement of rack 220 in the proximal direction. As rack 220 moves proximally from the position shown in FIG. 19A to the position shown in FIG. 19E, supports 218a-d (FIGS. 8A-E) slide proximally along housing flanges 292a-b (FIGS. 7A-B). Proximal movement of rack 220 may be sufficient to move v-shaped protrusion 229a on rack 220 from recess 222a, over protrusions 296a and 296b, and into recess 222c on inner wall 290 of housing portions 210L-R. Additionally, movement of prongs 229a over prongs 296a and 296b can optionally trigger an audible and / or tactile indication, such as a single or double click sound, that pusher element 230 is retracted and second anchor 280 is primed, notifying the user that it is ready for deployment. Optionally and / or alternatively, electronic circuitry may be provided to indicate to the user that pusher element 230 has been retracted.

[0221] A further particular feature of some embodiments of the present invention is that in this retraction orientation, locking element 342 remains disengaged from rack 220 and may prevent further advancement of pusher element 230 or further rotation in a counterclockwise direction as proximal end 224 abuts stop 293b provided on housing 210. Because rack 220 cannot move further proximally, engagement of teeth 225 of rack 220 with teeth 382 of roller 212 optionally prevents roller 212 from further rotation in a counterclockwise direction.

[0222] In this retraction orientation, first anchor 270 remains deployed outside of needle 250, as shown in FIG. 19F.

[0223] A particular feature of some embodiments of the invention is that, while pusher 230 is being retracted proximally from the position of Figures 19A-B to the position of Figures 20A-B, second anchor 280 may be released from pusher 230 into interior volume 258 of needle 250, optionally into suture holder 240, and may no longer be mounted on pusher 230. Rather, proximal end 284 of second anchor 280 optionally abuts and / or is optionally supported by distally facing surface 262 of anchor stopper 260 in this retracting orientation, thus preventing second anchor 280 from being displaced proximally beyond anchor stopper 260.

[0224] In FIG. 19F, it is shown that the distal end 324 of the pusher 230 can now be spaced proximally from the proximal end 284 of the second anchor 280 .

[0225] 20A-D, the system 200 is shown still in the retracted orientation after the needle 250 has been withdrawn from the tissue 206. The roller 212 is still in the position shown in FIG 20E, in which the markings 390R on the roller 212 may be visible.

[0226] As shown in Figures 20A-B, when a first anchor 270 is deployed outside the needle 250 and a second anchor 280 remains inside the needle, suture portions 288a-c extend from anchor 270, on one side of tissue 206, through the tissue, and to anchor 280, which is still inside the needle 250 (Figure 20B).

[0227] For example, as discussed above with respect to Figures 19E-20D, it should be noted that after the first anchor 270 is deployed, the pusher element 230 is retracted, followed by withdrawal of the needle from the tissue 206. Alternatively, the order of these operations can be reversed, such that the first needle 250 is withdrawn from the tissue 206, and then the pusher element 230 is retracted.

[0228] Optionally, it may be desirable to use an anchor configuration known in the art as a "vertical mattress" to implant the second anchor 280 in the same location on the tissue 206. In this case, the needle 250 may be reinserted into the tissue 206 in the same location where it was inserted for deployment of the first anchor 270. Alternatively, it may be desirable to use an anchor configuration known in the art as a "horizontal mattress" to implant the second anchor 280 in a different location than where the first anchor 270 was deployed. In this case, the needle 250 may be inserted into the tissue 206 in a different location than where it was inserted for deployment of the first anchor 270. According to an embodiment described below with reference to FIGS. 20E-22C, the first and second anchors 270 and 280 are deployed in a horizontal mattress configuration.

[0229] 20E-G, when it is desired to deploy a second anchor 280 through tissue 206, needle 250 is again inserted through tissue 206. System 200 is still shown in a retracted orientation. Note that roller markings 390R (FIG. 20D) may still be shown on roller 212 to indicate that pusher element 230 has been retracted.

[0230] Reference is now made to Figures 21A-D, which illustrate the operational deployment orientation of the second anchor, according to some embodiments. In this configuration, deployment of the second anchor 280 is actuated by rotating the roller 212 in a clockwise direction from a retracted position (Figure 20D), where marking 390R is visible on the roller 212, to a deployed position, where marking 390D is visible on the roller 212, as shown in Figure 21D.

[0231] Clockwise rotation of roller 212 optionally affects distal movement of rack 220 due to engagement of roller teeth 382 with teeth 225 on rack 220, for example, as discussed herein with respect to FIGS. 9A-C. This distal movement of rack 220 is accompanied by corresponding distal movement of pusher element 230 attached to distal end 226 of rack. As rack 220 advances distally, pusher element 230 advances distally adjacent distal end 254 of needle 250, which can push second anchor 280 out of needle 250. Second anchor 280 deployed through tissue 206 can be seen, for example, in FIGS. 21A-D. As discussed above, with respect to deployment of first anchor 270, movement of components within device 204 can trigger an audible indication, such as, for example, a double click sound, and / or a tactile indication, which informs the user that second anchor 280 has been deployed. Optionally and / or alternatively, electronic circuitry may be provided to indicate to a user that the second anchor 280 has been deployed. A further special feature of some embodiments of the present invention is that in this second anchor deployment operational orientation, the locking element 342 remains disengaged from the rack 220. However, further clockwise rotation of the roller 212 may be prevented from the roller position shown in FIG. 21D, e.g., as described in detail herein with respect to FIGs. 19A-D.

[0232] 21D , in this second anchor deployment operating orientation, it can be seen that second anchor 280 has optionally been pushed distally due to distal displacement of pusher 230 and engagement of distal end 324 of pusher 230 with proximal end 284 of second anchor 280. Second anchor 280 may now be disposed distally relative to distal end 254 of needle 250 and may be deployed from interior volume 258 of needle 250 and through tissue 206 of the patient.

[0233] 18A-19H and 21A-D, optionally, distal end 254 of needle 250 can be inserted through tissue 206 to exit the tissue at least a large enough distance so that the entire length of anchors 270 and 280 are deployed through the tissue. Optionally, and alternatively, if only distal tip 253 of needle 250 penetrates tissue 206 and a portion of distal end 254 of the needle is still within the tissue, anchors 270 / 280 do not exit the tissue completely.

[0234] 22A-C, system 200 according to some embodiments of the present invention is shown after second anchor 280 is deployed (FIGS. 21A-D) and after device 204 is moved away from tissue 206, thereby withdrawing needle 250 from the tissue, as seen most clearly in FIG. 22B.

[0235] It should be noted that in this configuration, the suture portions 288a-c attached to the first and second anchors can be released from the device and extend proximally through the tissue 206. Although the suture portions 288a-c are shown as single lines in FIG. 22B, those skilled in the art will understand that the reference numerals 288a-c in this figure represent a small loop 288a, a large loop 288b, and a free end 288c of the suture. For example, the suture material may optionally be tightened to secure the first and second anchors 270 / 280 to the tissue, and thereby potentially the tissue anchor portions together, as described in more detail below with reference to FIGS. 23A-G.

[0236] 23A-G, there is shown the fastening of first anchor 270 and second anchor 280 to tissue 206 after deployment of the anchors from device 204. Anchors 207 and 280 are shown in FIGURES 23A-B loosely held in position adjacent one side of tissue 206, with the suture material including small and large loops 288a-b and free suture end 288c on the opposite side of the tissue.

[0237] In the illustrated embodiment, anchors 270 and 280 are shown optionally as generally U-shaped, although the anchors may alternatively be shown as straight or slightly C-curved, respectively, depending, for example, on the stiffness of the anchors and how tightly they are pulled by the suture material.

[0238] To secure anchors 270 and 280 firmly against tissue 206, long suture portion 288b can be pulled. This shortens small loop 288a, causing each of the anchors to assume a narrow U-shape and clamp against tissue 206, as shown in FIGS. 23C-D. Free end 288c of the suture can then be pulled by the user. This shortens large loop 288b, as shown in FIGS. 23E-G. Because free end 288c of the suture is pre-twisted around large loop 288b, pulling this free end creates a knot in the suture material as large loop 288b becomes smaller. Excess suture length can then be cut off, optionally using a cutting device, such as that described in U.S. Pat. No. 6,866,673.

[0239] According to an alternative embodiment, both the first and second anchors may be loaded together in parallel into the sheath, and each of the anchors may optionally be covered by an elastic cover. Both anchors may be loaded together into a single needle, and a drive assembly may be provided having a first rack coupled to a first pusher that deploys the first anchor 270, and a second rack coupled to a second pusher that deploys the second anchor 280. Optionally, when the first rack is advanced distally to deploy the first anchor, the second rack is in a lag mode. Optionally, when the first rack is retracted, the second rack is advanced distally to deploy the second anchor.

[0240] Additionally, according to another alternative embodiment, the system may include more than two anchors. For example, a single solid anchor deployable may be provided, as described above with respect to Figures 19A-D, and two or more tubular anchors may be provided that are attached to and deployable by the pusher element. Optionally, two or more tubular anchors may be deployed at the same distal displacement of the pusher element, depending on how far the pusher element is retracted.

[0241] Optionally, the anchors according to any of the described embodiments may or may not be attached by suture material. Note that system 200 may be configured to be disposable.

[0242] Method of the invention 24, a method 500 of transferring multiple anchors into tissue of a patient is shown in accordance with certain features of some embodiments of the present invention. At 502, a sheath may be transferred through tissue, the sheath being, for example, a hollow needle, optionally having a sharp tip, as discussed herein. At 504, an actuator may be displaced proximally to deploy a first anchor. For example, as discussed herein, the actuator displacement may be, for example, a linear displacement of a trigger or a rotational movement of a roller. Thereafter, at 506, the actuator may be displaced distally to load a second anchor, followed by another displacement of the roller in the proximal direction at 508 to deploy the second anchor 280.

[0243] 25, a particular feature of some embodiments of the present invention is that a method 600 of operation of a device for transferring multiple anchors into a patient's tissue optionally includes proximal displacement of an actuator to displace a pusher distally through a sheath at 602. For example, as discussed herein, the displacement of the actuator may be, for example, a linear displacement of a trigger or a rotational movement of a roller. At the same time, at 604, the pusher is displaced distally an amount sufficient to deploy the first anchor from the sheath. Then, at 606, distal displacement of the actuator moves the pusher proximally, thereby loading the second anchor. Then, at 608, displacement of the roller in the proximal direction moves the pusher distally through the sheath. At the same time, at 610, the pusher is displaced distally an amount sufficient to deploy the second anchor 280 from the sheath.

[0244] It should be noted that the device may be operated outside the body, for example according to the operations set forth above, and / or may be operated when not during a medical procedure, for example during testing of the device.

[0245] It is anticipated that many related anchor systems will be developed during the life of the patent from this application, and the scope of the term anchor is intended to include a priori all such new technologies.

[0246] As used herein, the term "about" refers to ±10%.

[0247] The terms "comprises," "comprising," "includes," "including," "having," and combinations thereof mean "including, but not limited to."

[0248] The word "consisting of" means "including and limited to."

[0249] The term "consisting essentially of" means that a composition, method, or structure may contain additional components, steps, and / or moieties, but only if the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0250] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, the term "a compound" or "at least one compound" can include a plurality of compounds, including mixtures thereof.

[0251] Throughout this application, various embodiments of the present invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the present invention. Thus, the description of a range should be considered as specifically disclosing all possible subranges as well as individual numerical values ​​within that range. For example, the description of a range such as 1-6 should be considered as having specifically disclosed subranges such as 1-3, 1-4, 1-5, 2-4, 2-6, 3-6, and individual numbers within that range such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0252] Whenever a numerical range is given herein, it is meant to include any recited numbers (fractional or integer) within the given range. The phrases "ranging between" a first given number and a second given number, and "ranging from" a first given number "to" a second given number are used interchangeably herein and are meant to include the first and second given numbers, and all decimals and integers therebetween.

[0253] It will be understood that particular features of the invention that are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, for brevity, various features of the invention that are described in the context of a single embodiment may also be provided separately or in any suitable subcombination or as appropriate with any other described embodiment of the invention. Particular features described in the context of various embodiments are not to be regarded as essential features of those embodiments, unless the embodiment is inoperable without those elements.

[0254] While the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, the present invention is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0255] All publications, patents, and patent applications mentioned in this specification are incorporated herein by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated herein by reference. Furthermore, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.

Claims

1. a sheath having a proximal end and a distal end and having a passageway extending therethrough, the distal end of the sheath configured to penetrate tissue into which the first anchor and the second anchor are deployed; a pusher element having at least a distal end positioned within the passageway, the distal end of the pusher element sized and shaped to be displaced through the passageway; the first anchor is disposed within the sheath, the first anchor having a proximally-facing end surface, the proximally-facing end surface of the first anchor being disposed distally relative to the pusher element; the second anchor is disposed completely within the sheath prior to its deployment, proximally relative to the first anchor, the second anchor being disposed within the passageway and mounted on the pusher element and sized and shaped to be displaced along the passageway and released from the pusher during proximal retraction of the pusher; both the first anchor and the second anchor are configured to be deployed by the one pusher element; the pusher element is sized and shaped to be displaced in a distal direction, the pusher element configured to abut the proximally-facing end surface of the first anchor, the distal displacement of the pusher element having a first displacement length sufficient to deploy the first anchor; the pusher element is sized and shaped to be displaced proximally to a position proximal to at least a distal portion of the second anchor; the displacement of the pusher element has a second displacement length that is a length in a distal displacement, the second displacement length being at least as long as a distance between the proximal end of the second anchor and the distal end of the sheath and sufficient to deploy the second anchor.

2. the second anchor is tubular, and the system further includes a barrier narrowing the passage, the barrier preventing proximal displacement of the second anchor. The system of claim 1 .

3. the second anchor is laterally compressible and the pusher element is proximally displaceable to a position proximal to the second anchor.

3. A system according to claim 1 or 2.

4. the first anchor includes a blind bore at a proximal end thereof, and the distal end of the pusher element is sized and shaped to fit into the blind bore. A system according to any one of claims 1 to 3.

5. a distal end of the pusher element includes a retaining portion for temporarily retaining the second anchor thereon, the retaining portion being a recess for retaining the second anchor; A system according to any one of claims 1 to 4.

6. the pusher element comprises a compressible distal portion; A system according to any one of claims 1 to 5.

7. and a locking element for preventing proximal displacement of the pusher element. A system according to any one of claims 1 to 6.

8. and a drive unit for displacing the pusher element through the passage, the locking element obstructing a path of travel of the drive unit. The system of claim 7.

9. The sheath has a lateral opening at its distal end, the opening being large enough to allow at least two suture elements to pass therethrough. A system according to any one of claims 1 to 8.

10. the sheath having a lateral opening at a distal end thereof, the second anchor being positioned proximal to the lateral opening prior to deployment of the second anchor. A system according to any one of claims 1 to 9.

11. The first anchor is made of UHMWP (ultra-high molecular weight polyethylene); A system according to any one of claims 1 to 10.

12. the first anchor is a solid anchor. A system according to any one of claims 1 to 11.

13. an actuator mechanically coupled to the pusher element, movement of the actuator affecting a linear displacement of the pusher element along the passage; a drive unit for displacing the pusher element through the passage, the actuator mechanically coupled to the drive unit; a displacement of the actuator in a distal direction affects the displacement of the pusher element in a proximal direction via the drive unit; A system according to any one of claims 1 to 12.

14. and a housing for receiving the pusher element and at least a proximal portion of the sheath, the housing having a semicircular portion at a distal end thereof and a suture holder having a semicircular arm at a proximal end thereof, the arm and the housing portion together forming a passage sized for passage of a suture. A system according to any one of claims 1 to 13.

15. the sheath including a recess adjacent the passageway; prior to the proximal displacement of the pusher element, the pusher element is configured to interfere with positioning of the second anchor in the passage; the second anchor has a proximal end, the second anchor sized and shaped to be displaced along the passage; the proximal displacement of the pusher element prevents the interference of the pusher element with the positioning of the second anchor in the passageway. The system of claim 1 .

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