The present invention generally relates to soft tissue repair systems, for example, multiple anchor delivery systems.
It is known that various surgical procedures are performed in order to repair a deformed or torn soft tissue, such as meniscus, by means of suturing. There is a particular need for systems enabling delivery of several anchors during a single procedure.
U.S. Pat. Nos. 8,888,798 and 9,357,994, both to Smith & Nephew, Inc., each discloses a tissue repair device “wherein advance of the knob allows for engagement of the actuator with the first anchor and subsequent advancement of the first anchor.”
U.S. Pat. Nos. 9,498,203 and 9,549,725 to Smith & Nephew each disclose a tissue repair device including “a spring-loaded pusher” configured “for delivery of a flexible member to secure the tissue.”
U.S. Pat. No. 9,622,736 discloses a tissue repair device that “includes 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 couples the first and second anchors” (abstract).
Additional anchor repair devices are disclosed in U.S. Pat. Nos. 5,954,747; 6,306,156; 5,980,558; 5,993,459; 6,146,407; 6,595,911; 2003/0167072; US 2008/0167660; U.S. Pat. Nos. 9,249,266; 9,173,645; 5,236,445; 4,899,743; 4,946,468; 4,968,315; 5,002,550; 5,041,129; 5,123,914; 5,258,016; 5,372,604; 5,403,348; 5,417,712; 5,417,691; 5,626,614; 5,718,717; 5,954,747; 6,554,852; 6,511,498; 5,403,348; 7,857,830; 7,905,903; 7,601,165; 8,128,658; 7,959,650; 8,771,314; 8,298,262; 8,221,454; US 2014/0039552; U.S. Pat. Nos. 8,652,172; 8,828,053; 9,463,011; and 9,622,738.
The present invention seeks to provide an improved multiple anchor delivery system.
There is thus provided in accordance with some embodiments of the present invention a multiple anchor delivery system, including a driving unit and a hollow needle extending distally therefrom; a pusher element operatively coupled with the driving unit and extending distally therefrom within the hollow needle; a first solid anchor disposed within the hollow needle, distally with respect to the pusher element; and a second tubular anchor being threaded onto the pusher element.
Preferably, at least one of the first and second anchors is bio-absorbable. Further preferably, the driving unit includes a linearly displaceable trigger button. Still further preferably, the trigger button is configured for interaction with a pinion. The pinion is configured for interaction with a rack, which linearly displaces the pusher element within the hollow needle. Preferably, the pusher element includes a releasing feature for releasing the second anchor during retraction of the pusher element. Optionally, instead of a linearly displaceable trigger button, the driving unit may be actuated by a rotatable roller configured for interaction with a rack.
In accordance with some embodiments of the present invention, a method of delivering multiple anchors into a tissue of a patient, including delivering a hollow needle into a 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, which is opposite to the first direction, to load the second anchor; and displacing the trigger button in the first direction to deploy the second anchor.
Preferably, the trigger button is displaced proximally to deploy at least one of the first and the second anchor. Further preferably, the trigger button is displaced distally to load the second anchor. Still further preferably, a tactile indication for deployment of the anchor or for loading of the anchor is provided to a user during displacement of the trigger button.
According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; a pusher element having at least a distal end positioned within the passageway, the pusher element distal end sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the pusher element; and a second anchor disposed within the sheath, proximally with respect to the first anchor, the second anchor disposed within the passageway and, the second anchor sized and shaped to be displaced along the passageway; 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; and the pusher element sized and shaped to be displaced in the distal direction, the displacement of the pusher element having a second displacement length at least as long as the distance between the proximal end of the second anchor and the sheath distal end, the second displacement length sufficient to deploy the second anchor.
According to some embodiments of the invention, the second anchor overlaps axially with the pusher element.
According to some embodiments of the invention, the second anchor is tubular.
According to some embodiments of the invention, the pusher element sized and shaped to be displaced in a distal direction, into contact with the first anchor, the displacement having a first displacement length sufficient to deploy the first anchor.
According to some embodiments of the invention, the system further includes a barrier that narrows the passageway, the barrier obstructing a proximal displacement of the second anchor.
According to some embodiments of the invention, the second anchor is mounted on the pusher element.
According to some embodiments of the invention, the pusher element distal end includes a widened tip.
According to some embodiments of the invention, the pusher element extends through an interior of the second anchor.
According to some embodiments of the invention, the second anchor is compressible in a lateral direction.
According to some embodiments of the invention, the second anchor is compressible in a lateral direction, the pusher element displaceable in a proximal direction to a position proximal to the second anchor.
According to some embodiments of the invention, the first anchor includes a blind bore at its proximal end, the pusher element distal end sized and shaped to fit into the blind bore.
According to some embodiments of the invention, the pusher element distal end includes a retaining portion for temporarily retaining the second anchor thereon.
According to some embodiments of the invention, the retaining portion is a recess for retaining a second anchor.
According to some embodiments of the invention, the pusher element is provided with a compressible distal portion.
According to some embodiments of the invention, the first anchor is tubular.
According to some embodiments of the invention, at least one of the first and second anchor is provided with a channel along at least a portion of its length, the channel having a passageway sized for passage of a suture portion therethrough.
According to some embodiments of the invention, the sheath includes a hollow needle.
According to some embodiments of the invention, the sheath has a lateral opening at the distal end thereof, the opening large enough to for at least two suture elements to pass therethrough.
According to some embodiments of the invention, the sheath has a lateral opening at the distal end thereof, the second anchor positioned proximal to the lateral opening prior to deployment of the second anchor.
According to some embodiments of the invention, the sheath has a sharpened tip at its distal end.
According to some embodiments of the invention, the sheath distal end is curved.
According to some embodiments of the invention, the system further includes an actuator mechanically coupled to the pusher element, movement of the actuator affecting linear displacement of the pusher element along the passageway.
According to some embodiments of the invention, the system further includes a driving unit for displacing the pusher element through the passageway, wherein the actuator is mechanically coupled with the driving unit.
According to some embodiments of the invention, displacement of the actuator in a first direction affects via the driving unit the displacement of the pusher element in a second direction, the second direction opposite to the first direction.
According to some embodiments of the invention, the first direction is one of a proximal direction and a distal direction.
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 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 passageway sized for passage therethrough of a suture.
According to some embodiments of the invention, the system further comprises a locking element for preventing the proximal displacement of the pusher element.
According to some embodiments of the invention, the system further comprises: a driving unit for displacing the pusher element through the passageway; wherein the locking element obstructs a path of movement of the driving unit.
According to some embodiments of the invention, the first and second anchors are entirely housed within the sheath prior to their deployment.
According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; first and second pusher elements disposed inside the sheath, each pusher element having at least a distal end positioned within the passageway, the distal end of each the pusher element sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, at least a portion of the first anchor positioned distally with respect to the first pusher element; a second anchor disposed within the sheath, proximally with respect to the first anchor; the first pusher element displaceable in a distal direction, into contact with the first anchor, the displacement having a displacement length sufficient to deploy the first anchor; the second pusher element displaceable in a distal direction, into contact with the second anchor, the displacement having a displacement length sufficient to deploy the second anchor.
According to an aspect of some embodiments of the present invention there is provided a multiple anchor delivery system, comprising: a sheath having a proximal end and a distal end and having a passageway extending therethrough; a pusher element having at least a distal end positioned within the passageway, the pusher element distal end sized and shaped to be displaced through the passageway; a first anchor disposed within the sheath, at least a portion of the first solid anchor positioned distally with respect to the pusher element; and a second anchor disposed within the sheath, proximally with respect to the first anchor, the second anchor mounted on the pusher element.
According to some embodiments of the invention, the second anchor is tubular.
According to some embodiments of the invention, the pusher element distal end includes a retaining portion for temporarily retaining the second anchor thereon.
According to some embodiments of the invention, the pusher element extends through an interior of the second tubular anchor.
According to an aspect of some embodiments of the present invention there is provided a method of delivering multiple anchors into a tissue of a patient, comprising: delivering a sheath through a tissue such that a sheath distal end penetrates the tissue; displacing an actuator in a proximal direction to deploy a first anchor out of the sheath and through the tissue; displacing the actuator in a distal direction to position a proximal end of a pusher element at least partly proximally to the second anchor; and displacing the actuator in the proximal direction to engage the second anchor and to deploy the second anchor out of the sheath.
According to some embodiments of the invention, wherein the first anchor is provided with a suture portion, the suture portion deployed out of the sheath and through the tissue with deployment of the first anchor.
According to an aspect of some embodiments of the present invention there is provided a method of operation of a device for deployment of multiple anchors, comprising: first displacement of a pusher element through a sheath in a distal direction; 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 out of the sheath; displacement of the pusher element through the sheath in a proximal direction, to a position proximal to a second anchor; second displacement of the pusher element through the sheath in the distal direction; 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 out of the sheath.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
The present invention, in some embodiments thereof, relates to a soft tissue repair system, and, more particularly, but not exclusively, to a multiple anchor delivery system.
A multiple anchor delivery system and method is disclosed herein, which is particularly useful for repairing soft tissue, such as meniscus for example, but not limited to this particular surgical procedure. An aspect of some embodiments of the invention relates to deploying multiple anchors using a sheath. In some embodiments of the invention, two anchors are deployed from the sheath, sequentially, by a single pusher element, with one anchor being in contact with the pusher element and a second anchor being loaded into the sheath and located to a side of the pusher element. Optionally, the second anchor is mounted on and/or around the pusher element.
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 so that subsequent distal advancement of the pusher element will deploy the second anchor from the sheath.
In some embodiments of the invention, when the pusher element is retracted in a proximal direction, the second anchor is pulled back with the pusher element until the second anchor encounters an interfering geometry and is prevented from further retraction. In this way the pusher element is moved distally relative to the second anchor.
Exemplary embodiments of the invention comprise a system and method for deploying multiple anchors through a tissue of a patient. The system and method may be utilized, for example, in the repair of torn meniscus tissue, by deploying first and second anchors through the torn tissue portions and optionally tightening the anchors against the tissue portions, thereby potentially holding the separated tissue portions together so that they may mend together. According to some embodiments, the system includes a device including a sheath having a passageway extending therethrough. A pusher element is positioned in the passageway and displaceable relative to the sheath, in a distal direction and a proximal direction.
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 are sized and shaped to be positioned entirely within the passageway of a sheath, the first anchor positioned distally relative to the pusher element and the second anchor positioned proximally relative to the first anchor. Optionally, the first and second anchors are housed entirely within the sheath prior to deployment of the anchors.
A length of suture material may extend through the first and second anchors, forming a small loop and a large loop extending between the anchors. The small loop may extend from approximately the distal end of the first anchor to approximately the proximal end of the second anchor, and the free end may extend from approximately the proximal end of the first anchor, proximally through the device.
An aspect of some embodiments of the invention relates to deploying multiple anchors utilizing a sheath provided with a lateral opening such as, for example, a slot, at its distal end portion, the slot being wide enough for the small and large suture loops to pass therethrough. Optionally, the second anchor is positioned proximal to the lateral opening prior to deployment of the second anchor.
The device may include a tubular suture holder for retaining the suture material within a limited distance from the needle, thereby potentially preventing tangling of the suture material when the anchors are moved through the passageway.
According to some embodiments of the invention, the pusher element may be displaceable by linear displacement of a driving mechanism. The driving mechanism may be displaced by linear displacement of an actuator in the form of a trigger button. Alternatively, in some embodiments, the driving mechanism may be displaceable by rotation of a roller.
The actuator is movable in a distal direction and a proximal direction, the actuator coupled to the driving mechanism which is coupled to the pusher element. The coupling is arranged so that movement of the actuator in a distal direction results in displacement of the driving mechanism in a proximal direction, and that movement of the actuator in a proximal direction results in displacement of the driving mechanism in a distal direction.
The sheath may be inserted through a tissue such as, for example, a torn meniscus. The sheath should be inserted through the tissue such that the sheath distal end exits the tissue before deployment of the anchors is performed.
Once in position through the tissue, the device may be actuated by moving the actuator in a proximal direction, the pusher element is displaceable in a distal direction through the sheath so that it contacts the first anchor, the amount of displacement of the pusher element sufficient to deploy the first anchor from the sheath.
A barrier is positioned within the passageway at a location proximal to the second anchor, the barrier optionally in the form of a narrowing of the passageway so that it interferes with 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 location of the second anchor relative to the barrier and the direction of movement of the pusher element.
After the first anchor has been deployed, the pusher element is displaceable through the passageway in a proximal direction to a position proximal to at least a portion of the second anchor. As the pusher element moves proximally, the second anchor may be prevented from also moving proximally once it contacts the barrier in the passageway.
The needle may be removed from the tissue and reinserted through the tissue at another location where it is desired to deploy the second anchor. When the device is actuated by again moving the actuator in a proximal direction, the pusher element is then displaceable distally through the sheath so that is contacts the second anchor, the amount of displacement of the pusher element sufficient to deploy the second anchor from the sheath.
After the second anchor has been deployed, the suture loops may be tightened, to tighten the anchors against the tissue. The anchors in position may hold the torn tissue portions together so that they may heal.
An aspect of some embodiments of the invention relates to deploying first and second anchors from a sheath, where the first anchor may be solid and the second anchor may be hollow. A pusher element may be displaced proximally and distally within the sheath, the pusher element being insertable through the second anchor. After deployment of the first anchor, the proximal displacement of the pusher element is effective to move the pusher element to a position proximal to the second anchor, wherein the second anchor is effectively loaded and ready for deployment. Upon subsequent distal displacement of the pusher element, the pusher element distal end contacts a proximal portion of the second anchor and deploys the second anchor out of the sheath. Optionally, the pusher element has a distal end wider than the second anchor proximal end, the pusher element distal end optionally being compressed when the when inserted through the second anchor. Optionally, the second anchor has a compressible portion which is decompressed upon retraction of the pusher element to a location proximal to the second anchor.
An aspect of some embodiments of the invention relates to deploying first and second anchors from a sheath, where the second anchor may be solid, and is optionally compressible. Optionally, the second anchor is laterally compressible. The second anchor may be compressed by the pusher element such that it is positioned alongside the pusher element. Upon retraction of the pusher element, 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, when decompressed, has an external diameter equal to or greater than the inner diameter of the sheath. In some embodiments, at least one of the first and second anchors may be hollow at least along a portion of its length, the anchor radially compressed by the sheath until deployed out of the sheath by the pusher element.
An aspect of some embodiments of the invention relates to a system and method for deploying first and second anchors, where the pusher element includes a recess for retaining the second anchor. Optionally, the recess may be a notch sized and shaped to temporarily contain the second anchor. Optionally, the second anchor may be positioned within the recess such that the second anchor is at least mostly surrounded by the pusher element. Optionally, the second anchor may be positioned within the recess such that the second anchor 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.
An aspect of some embodiments of the invention relates to deploying multiple anchors, the first and second anchors deployed by respective pusher elements, the pusher elements optionally working in parallel within a single sheath.
In accordance with some embodiments, the system may be provided with an actuator which is displaceable proximally to deploy the first anchor. Optionally, the actuator may be a trigger button which may be linearly displaceable. Alternatively, the actuator may be a roller which may be rotatable. In embodiments there is the potential advantage that a finger of a user moves in a first direction and the anchor is deployed in the second direction opposite to the first direction. For example, a user may actuate a device by a movement of a trigger button in a proximal direction, which results in deployment of an anchor in a distal direction out of the sheath.
In embodiments, the system may be provided with a locking mechanism which prevents inadvertent or premature deployment of the anchors.
An aspect of some embodiments of the invention relates to deploying multiple anchors using a sheath including an opening such as, for example, a slot, at a distal portion thereof. Suture portions provided on or through the anchors may be allowed to extend out of the opening, thereby potentially preventing tangling of the suture portions. Optionally, at least a portion of the second anchor is disposed proximal to the opening. Optionally, the entire length of the second anchor is disposed proximal to the opening.
Before explaining 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 the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
A system and/or method in accordance with some embodiments of the present invention can provide one or more of a number of potential advantages not realized by the prior art. For example, the provision of a trigger button/roller, for example, as discussed herein may provide easy, one-handed actuation of the system by 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 can allow a user to have control over the deployment of the anchors which is not possible in some prior art devices such as, for example devices wherein deployment of the anchors is by a spring-loaded mechanism.
Additionally, the provision of a system wherein finger movement of the user in a first direction results in displacement of the pusher element in a second direction, together with the provision of a safety latch/lock for example, as described herein, may prevent premature/inadvertent deployment of anchor(s).
Further, the ergonomic shape of the handle can allow the needle to be more easily maneuverable through the tissue, which may result in more accurate positioning of the anchors after deployment. Also, the ergonomic shape and operation of the handle and actuating mechanism, in the form of a trigger button or roller, together with engageable pusher driving unit results in less pressure required to deploy the anchors as compared with prior art devices.
Yet further, the provision of a slot in the needle through which the loops extend may allow for easier deployment of the anchors, as the loops/sutures may not interfere with movement of the anchors through the passageway, and the provision of a slot through which the loops extend may prevent tangling of suture material as the anchors are deployed from the needle.
Yet further, as in any device to be inserted into the human body, there is a limited amount of space within which to work. Having a pusher element inserted through the second anchor may save space within the device.
Yet further, provision of a bobbin on which suture material is wound may prevent tangling of the suture material within the housing.
These and other potential advantages may be apparent to persons skilled in the art.
These and other aspects of some embodiments of the invention are described herein, with reference to the accompanying drawings.
Reference is now made to
A system for delivery of multiple anchors in accordance with some embodiment is shown in
It is seen in
The handle mechanism 102 has a housing 110, which is optionally made from plastic by injection molding. The housing 110 defines a handle which may be grippable by a user and is configured to contain the mechanism responsible for delivery of anchors through the needle assembly 104.
It is particularly seen in
The pinion 118 also interacts with a rack 120. The rack 120 optionally has a first wall, which optionally includes a plurality of indents 122, for interaction with an optional leaf spring 124. The rack 120 further has a second wall, which is configured for slidable mounting of a support element 126 thereon. The rack 120 optionally has a projection 127 that is configured for fixed connection to a pusher element 130, which is configured to displace the anchors throughout the needle assembly 104. It is appreciated that the pusher element 130 is optionally solid and optionally made of stainless steel. Optionally, the pusher element 130 is not solid and may be optionally made of other material(s).
It is seen that the rack 120 is optionally disposed in parallel and may be spaced from elongated toothed portion 116 of trigger button 112.
It is seen in
A support hub 131 is optionally formed within housing 110 of handle mechanism 102.
A needle depth limiter 132 is optionally connected to the support hub 131. The needle depth limiter 132 optionally includes a hub portion 134, which is rigidly coupled to the housing 110 and an elongated hollow cannula 136, extending along longitudinal axis 109.
It is further seen in
The needle assembly 104 includes a hollow needle 150, having a proximal end 152 and a distal sharpened end 154. The hollow needle 150 also defines an inner surface 156 and an interior volume 158. It is appreciated that the hollow needle 150 is optionally made of stainless steel.
It is seen particularly in the enlargement view of
An anchor stopper 160 is optionally located within the interior volume 158 of needle 150, at the proximal portion of the needle 150 and optionally defines a distally facing surface 162.
It is a particular feature of some embodiments of the present invention that a first anchor 170 is optionally solid and is disposed within the interior volume 158 of needle 150 distally to the pusher 130. The first anchor 170 has a proximal end 172 and a distal end 174, and it is seen that proximal end 172 may abut the distally facing end surface 159 of the pusher 130 in this initial operative orientation. It is noted that the first anchor is optionally soft, made of Polyethylene or Polypropylene. It is appreciated that alternatively, the anchor can be rigid. It is additionally noted that the first anchor 170 may be bio-absorbable.
It is a further particular feature of some embodiments of the present invention that a second anchor 180 is disposed proximally with respect to the first anchor 170 and the second anchor is optionally tubular, defining an inner surface 182. It is noted that the second anchor is optionally soft, made of Polyethylene or Polypropylene. It is appreciated that alternatively, the anchor can be rigid. It is additionally noted that the second anchor 180 may be bio-absorbable.
The second anchor 180 is threaded over the pusher 130, so that the inner surface 182 of the second anchor engages the 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 in the vicinity or abuts the distally facing surface 162 of the anchor stopper 160. The distal end 186 of the second anchor 180 is disposed distally 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 proximally to the proximal end 172 of the first anchor 170, for example, as shown in
It is seen that the distal end of elongated hollow cannula 136 of the needle depth limiter 132 is disposed proximally of the distal sharpened end 154 of the hollow needle 150. Since the outer diameter of the cannula 136 is substantially larger than the outer diameter of the hollow needle 150, the penetration depth of the needle 150 into the tissue of the patient is limited to the extent to which the needle projects distally with respect to the distal end of cannula 136.
It is seen in
It is a particular feature of some embodiments of the present invention that actuation of the trigger button 112 optionally affects displacement of the pusher 130 in the following manner: The user places his finger on gripping portion 114 and displaces the trigger button 112 proximally, thereby elongated toothed portion 116 of the trigger button 112 activates pinion 118, which in turn displaces the rack 120 distally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 is thereby also displaced distally.
During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is positioned in a different one of its operative orientations.
It is a further particular feature of some embodiments of the present invention that in this initial operative orientation the safety latch 140 is supported against the shoulder formed by projection 119 of the trigger button 112, which prevents distal displacement of the trigger button 112. This is a safety feature intended to prevent inadvertent deployment of anchor from the system 100. In this initial operative orientation, the trigger button 112 can only be displaced in a proximal direction, which is not intuitive for the user.
It is seen in
Reference is now made to
It is seen in
The user displaced the trigger button 112 proximally, thereby elongated toothed portion 116 of the trigger button 112 activated pinion 118, which in turn displaced the rack 120 distally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 was thereby also displaced distally.
During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is now positioned in the proximal position.
It is a further particular feature of some embodiments of the present invention that in this first anchor deployment operative orientation, the safety latch 140 disengaged from the shoulder formed by projection 119 of the trigger button 112, thus no longer preventing distal displacement of the trigger button 112. In this first anchor deployment operative orientation, the trigger button 112 can be displaced both in proximal and in distal directions.
It is seen in
Reference is now made to
It is seen in
The user displaced the trigger button 112 distally, thereby elongated toothed portion 116 of the trigger button 112 activated pinion 118, which in turn displaced the rack 120 proximally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 was thereby also retracted proximally.
During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is now positioned in the distal position. Alternatively, in some embodiments, proximal movement of the rack 120 from the position in
It is a further particular feature of some embodiments of the present invention that in this retraction operative orientation, the safety latch 140 remains disengaged from the shoulder formed by projection 119 of the trigger button 112, thus no longer preventing distal displacement of the trigger button 112.
It is seen in
It is a particular feature of some embodiments of the present invention that during proximal retraction of the pusher 130, the second anchor 180 is released from the pusher 130 and is not mounted over the pusher 130 anymore, rather the proximal end 184 of the second anchor 180 abuts and is supported against distally facing surface 162 of the anchor stopper 160 in this retraction operative orientation, thus preventing proximal displacement of the second anchor 180.
It is seen in
In this retraction operative orientation, the pusher 130 is ready for deploying the second anchor 180 in a manner similar to the deployment of the first anchor 170.
It is noted that an additional element may be formed on the distal end of pusher 130, such as, for example, a hook, to ascertain release of the second anchor 180 off the outer surface of the pusher 130 and loading thereof for deployment into the tissue of the patient.
Reference is now made to
It is seen in
The user displaced the trigger button 112 proximally, thereby elongated toothed portion 116 of the trigger button 112 activated pinion 118, which in turn displaced the rack 120 distally due to the interaction between the rack 120 and the pinion 118. Since the pusher 130 is connected to rack 120, the pusher 130 was thereby also displaced distally.
During displacement of the rack 120, the leaf spring 124 is being positioned within a subsequent one of the indents 122, thereby potentially providing tactile indication to the user, indicating that the trigger button 112 is now positioned in the proximal position. Alternatively, in some embodiments, proximal movement of the rack 120 from the position in
The safety latch 140 remains disengaged from the shoulder formed by projection 119 of the trigger button 112, thus permitting displacement of the trigger button 112 in both proximal and distal directions.
It is seen in
It is a particular feature of some embodiments of the present invention that the method of delivering multiple anchors into the tissue of the patient optionally includes delivery of the system 100 into the desired surgical location, displacement of a trigger button 112 in a first direction to deploy the first anchor 170, thereafter displacement of the trigger button 112 in a second direction, which is opposite to the first direction, to load the second anchor 180; and thereafter another displacement of the trigger button 112 in the first direction to deploy the second anchor 180. In some embodiments, the first direction is a proximal direction and the second direction is a distal direction.
It is noted that the trigger button 112 described with reference to
It is appreciated that the system 100 provides an indication to the user that the second anchor 180 is loaded and ready to be deployed.
It is appreciated that alternatively the system 100 can deploy the first anchor 100 and thereafter during retraction of the pusher, the second anchor 180 that was initially disposed out of the interior volume 158 of the needle 150 is loaded onto the 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 most proximal position.
Further alternatively, both first anchor 170 and second anchor 180 may be loaded together in parallel, and each of the anchors is optionally covered by a resilient cover. Both anchors are loaded together into a single hollow needle 150 and a driving assembly having a first pusher that deploys the first anchor 170 and a second pusher that deploys the second anchor 180.
It is noted that the system 100 is optionally configured to be disposable. After use, the device may be disposed of in a disposal container approved by the local authority.
It is noted that the trigger button 112 described with reference to
With reference to
With additional reference to
In accordance with some embodiments, some of the components shown in
Optionally, in some embodiments, the bobbin 300 may be replaced by another mechanism for storing the length of suture that extends from the first anchor into the handle. Optionally, there is no mechanism for storing the length of suture, and the length of suture may be stored inside the housing 210 or at least partly extends outside the housing.
In the embodiment shown, sheath 250 may be configured as a hollow needle having a circular cross-section. Needle 250 has a proximal end 252 and a distal end 254 and may be fabricated of, for example stainless steel of grade SS304, although other materials are possible. Needle 250 may have a length in the range of, for example, 176.3-176.7 mm; an outer diameter in the range of, for example, 1.8-2.55 mm; and an inner diameter in the range of, for example, 1.15-1.5 mm.
The 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 needle distal end 254, may have a lateral opening formed therein, such as, for example, slot 155, optionally opposite the side having the sharpened tip 253. Slot may have a length in the range of, for example, 29-30 mm and a width in the range of, for example, 0.8-0.9 mm.
Slot 255 is optionally large enough to accommodate the passage therethrough of suture loops 288a-b and suture free end 288c, for example, as discussed further herein, for example with regard to
While, in the embodiment shown, needle 250 is shown as having a straight configuration, it is to be understood that, optionally and alternately, the needle distal end 254 may be curved, as known in the art. Needle 250 may have a curvature having a radius of curvature in the range of, for example, 99-100 mm; for a length in the range of, for example, 20-22 mm; and a height in the range of, for example, 2-3 mm.
Optionally, the needle may be bendable, for example, which may prevent damage to tissue. Optionally, the needle may have more than one curve and/or curve in more than one plane. It will be appreciated by person skilled in the art that if the needle is curved the pusher element is optionally thick enough and flexible enough to avoid buckling as it is displaced along the curved needle.
A pusher tip 322 may be provided at the pusher proximal end 324, the tip 322 optionally being compressible. Optionally, pusher element 230 has a widened portion 323 at tip 322. Optionally, widened portion 323 may be compressible. The pusher element is optionally flexible enough to be resistant to buckling and to be able to transfer a force required to overcome friction between each of the anchors 270/280 and an inner surface 256 of the needle 250. Optionally, the needle inner surface 256 is coated to reduce such friction.
According to some embodiments, the pusher element may be provided with an indentation or notch for retaining therein a second anchor. Optionally, the pusher element distal end and/or the second anchor may be compressible. When the pusher element is retracted, for example, as discussed herein with regard to
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 when deploying the first anchor. When the pusher element is retracted it may release the second anchor from the needle recess, by no longer blocking it from decompressing into the needle lumen, thereby potentially allowing the second anchor to be positioned for subsequent deployment.
Each of first anchor 270 and second 280 may be fabricated from 8-16 braided or woven strands of USP 4-0 or 2-0 Fiber Wire™, although other materials and/or sizes may be usable such as, for example, ultra-high molecular weight polyethylene (UHMWP), polyester polypropylene, or silicone elastomer coating, optionally dyed using D&C Blue No. 6, D&C Green No. 6, and/or Logwood Black dyes, as known in the art.
Optionally, either or both of anchors 270 and 280 may include a silicone elastomer coating. Each of anchors 270 and 280 has a length in the range of, for example, 11-13 mm; and an outer diameter in the range of, for example, 1.2-1.4 mm. Second anchor 280 may have an inner diameter in the range of, for example, 0.65-0.86 mm. A length 288 of suture material may extend through the anchors, optionally having a small portion 288a forming a small loop between first anchor proximal end 272 and second anchor distal end 286, a large portion 288b forming a large loop between the first anchor distal end 274 and the second anchor proximal end 284, and a free end 388c extending proximally from the first anchor proximal end. The length 288 of suture material may be formed of, for example, 2-0 Fiber Wire™, although other materials may optionally be used. Optionally, the length of the small portion 288a of suture material is 50 mm, the length of the large portion 288b of suture material is 220 mm, and the length of the suture free end 288c is 300 mm, although other lengths may be used.
One or both of first anchor 270 and second anchor 280 are optionally soft and/or flexible enough so as not to cause damage to tissue or vessels in the vicinity of 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 may be bio-absorbable, optionally maintaining mechanical strength of the anchor or anchors until tissue 206 is healed such as, for example, 1-3 months.
For example, as discussed herein, in accordance with some embodiments, optionally, the first anchor may be a solid anchor optionally having a blind bore at a proximal end thereof, into which a pusher element distal end may be inserted prior to deployment of the first anchor. In this embodiment, the pusher element distal end may not contact the first anchor proximal end, as in the embodiment shown in
In accordance with a further alternative embodiment, the first anchor 270 may be hollow, and the pusher element may be disposed proximal relative to the first anchor, the pusher element configured to contact the first anchor proximal end, to deploy the firs anchor. Optionally or additionally, the pusher element may be disposed partly within the interior of the first hollow anchor, the pusher element having a distal end configured to engage the inner surface of the first anchor, thereby potentially deploying the first anchor when the pusher element is moved distally.
In some embodiments of the invention, second anchor 188 may optionally be replaced with a solid anchor which is optionally compressible, for example, as discussed herein with regard to
In some embodiments, the anchors are provided with suture portions which allow tightening of the anchors against the tissue after deployment of the anchors. Optionally, suture material is threaded at least partly through the interior of second anchor 280. Optionally, suture material may be threaded at least partly through the material of first anchor 270 and/or the material of the second anchor 280.
Optionally, each of a first anchor 270 and a second anchor 280 may have a collar or channel (not shown), extending alongside an outer surface of the anchor, the channel configured for retaining therein a portion of suture material 288. The anchors 270 and 280 may be positioned within the needle 250 such that the suture portions 288a-b and suture free end 288c and/or the channels protrude out of the needle slot 255.
It should be noted that, depending on the shape of the bore through the hollow anchor 280 and the shape of an opening into the bore of the second anchor, the second anchor 280 may be flexible enough and the distal end 324 of pusher element 230 may be narrow enough so that the pusher element may pass through the interior 281 of the second anchor 280. In addition, distal end 324 of the pusher element 230 may be wide enough so that, after retraction out of the second anchor 280, the pusher element will push the second anchor distally. This is discussed further below.
Referring to
According to some embodiments, a lower surface 223 of rack 220 may be provided with a recess 228 having distal and proximal surfaces 228a-b, near the rack proximal end 224. The rack 220 may also be provided with flexible strips 229 which appear as curved portions protruding from the sides of the rack. The middle of each strip 229 has a v-shaped projection 229a extending away from the rack 220. The rack 220 may include a plurality of support portions 218a-d extending out of the sides of the rack 220, where support portions 218a-b are positioned at the rack distal end and support portions 218c-d are positioned near the rack proximal end. One or more of these elements may be described in more detail herein.
With reference to
A roller 212c may optionally be provided with a peg 392 projecting out of the surface 391 of the roller 212a-c, which may be used for positioning the roller within the housing.
A roller 212a-c may optionally be provided with position markings 390a-c for indicating to a user the rotational position of the roller. For example, as shown in
With reference to
Cannula 236 is positioned over the needle and over the suture holder, if it is present. The cannula distal end 235 may be moved relative to the needle distal end 254, to adjust the length of the needle that extends out of the cannula. This is discussed further herein with regard to delimiter 360. It should be noted that the inner diameter of the cannula 236 must be larger than the outer diameter of the needle 250, such that the needle 250 may be inserted into the cannula 236, optionally with a suture holder 240 in between the cannula inner surface and the needle outer surface.
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 fabricated of PTFE and has a length in the range of, for example, 130-132 mm; an inner diameter in the range of, for example, 2.6-.2.8 mm; and an outer diameter in the range of, for example, 3.0-3.2 mm; with a cutaway portion extending 5-6 mm from the suture holder proximal end 244.
At its proximal end 244, suture holder has a cutaway portion such that the proximal end is provided with a semicircular arm 243 having a horizontal edge 245. Edge 245 intersects a vertical edge 241 at a right angle. The suture holder 240 will be discussed further herein with regard to assembly of components of the system 200.
It should be noted that the inner diameter of the suture holder 240 must be larger than the outer diameter of the needle 250, such that the needle 250 may be inserted into the cannula 236. In addition, the inner diameter of the suture holder should be large enough so that there is enough room in between the inner surface of the suture holder and the outer surface of the needle for the presence of suture loops 288a-b. With reference to
With further reference to
The inner wall 290 of right housing portion 210R may be provided with a pair of parallel flanges, an upper flange 292a and a lower flange 292b, between which there may be situated projections 296a and 296b. A first recess 222a may be formed between flanges 292a and 292b, proximal to projection 296a; a second recess 222b may be formed between flanges 292a and 292b, between projections 296a and 296b; and a third recess 222c may be formed between flanges 292a and 292b, distal to projection 296b. Also on the inner wall 290 of right housing portion 210R there may be provided a roller mounting peg 299, locking element stops 295a and 295c, a bobbin holder 298, stops 293a-b, and a locking element peg 294. It may be noted that stop 295a is configured as a curved portion projecting out of housing inner wall 290, the curved portion having a small knob 295b at its upper end. Near the housing distal end 215 there may be provided clamping bars 297. These elements will be discussed further herein with regard to assembly and operation of system 200.
It will be appreciated by persons skilled in the art that, optionally, a left housing portion (not shown) may be formed similar to housing portion 210R, but with components in a laterally reversed configuration. The left and right housing portions 210L-R may be configured to be snap fitted together, or to be otherwise joined, for example, by being glued or screwed together, as known in the art, to form a housing 210.
The housing 210 may be fabricated from any suitable material such as, for example, plastic, optionally by injection molding. The housing 210 may be configured to partly contain a mechanism responsible for delivery of anchors through a tissue, for example, as discussed herein with regard to assembly and operation of system 200.
In accordance with some embodiments, system 200 may be assembled as follows: First the proximal end 326 of pusher element 230 may be inserted through the distal end 286 of hollow anchor 280. It may be noted that the inner surface 282 of the second anchor 280 may or may not engage an outer surface of the pusher element 230.
The pusher element proximal end 326 may then be inserted through the distal end 254 of a needle 250 until it extends out of the needle proximal end 252, and the hollow anchor may be positioned within the needle 250, optionally with suture loops 288a-b positioned outside the needle slot 255. Then the first anchor may be inserted into the needle distal end 286, optionally with the suture loops 288a-b positioned outside the needle slot 255, and the suture free end 288c optionally extending proximally within the needle. Optionally, the small and large suture loops 288a-b may be adjusted such that they have the desired measurements, for example, as discussed herein with regard to
The pusher element proximal end 326 may then be inserted into bore 227 in rack 220 and attached thereto, for example, by a set screw, making sure that the needle is positioned with the slot on the same side as the teeth 225 of the rack 220.
Needle proximal end 252 may be inserted into the distal end 242 of a suture holder 240, and the suture holder may be passed over the needle, optionally until almost all of the needle slot 255 extends past the suture holder distal end 242. Optionally, approximately 2-3 mm of the needle slot 255 is covered by the suture holder 240.
A locking element 342 may be positioned relative to rack 220 such that the locking bar 346 is disposed within the recess 228 in rack 220. Then the rack and locking element are positioned within a half portion of a housing 210, e.g., right housing portion 210R, with rack support portions 218b and 218d disposed in 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 with cannula positioned within housing hub 231.
In some embodiments, at this point the suture holder 240 may be adjusted so that the semicircular arm 243 is positioned inside the right portion of housing collar 231 in housing portion 210R, with the semicircular arm oriented such that it forms a complete circle together with the right portion of collar 231, and with vertical edge 241 of suture holder 240 abutting the edge 233 of housing collar 231. This ensures that the suture free end 288c passes through the circle formed by the semicircular arm 243 and the right portion of housing collar 231, thereby potentially preventing possible accidental closure of the housing portions 210L-R on the suture free end 288c.
The suture free end 288c may be optionally threaded through the bore 306 in bobbin 300 and the suture may be wound around bobbin spool 302, after which bobbin may be positioned in housing portion 210R, with bobbin rod 308 in holder 398 of right housing portion 210R. The portion of suture free end 288c that extends between the cannula proximal end 237 and the spool 302 should be positioned within the housing hub 231. The bobbin may be wound tighter, if desired, optionally by inserting a tool into groove 310 at the end of rod 308.
A roller, such as, for example, roller 212c may be positioned in the right housing portion 210R with opening 381 on the roller mounting peg 299 in right housing portion 210R, with the peg 392 outside the right housing portion 210R, the peg 392 aiding in positioning of the roller relative to the housing portion 210R. In this configuration, the roller operative portion 380 is optionally disposed inside the right housing portion 210R, and the roller gripping portion 384c is optionally disposed outside the right housing portion 210R.
The left housing portion 210L may then be snap fitted onto or otherwise attached to the right housing portion, to form a closed housing 210 with the rack 220, locking element 342, and bobbin 300 inside, and with the roller 212a, partially inside and partially outside of the housing 210. Finally, the needle distal end 254 and cannula distal end 235 may be inserted through the collar 364 of delimiter 360, and delimiter 360 may be advanced over the cannula 236 until the delimiter is seated on the housing hub 231, with delimiter arms 361 inserted into apertures (not shown) in housing 210, and with delimiter indicator peg 368 adjacent markings 232 on the housing 210. Then the cannula 236 may be passed over the needle distal end 254 and over the suture holder 240. Force may be applied to the cannula 236, in a proximal direction, such that the cannula proximal end 237 is inserted into the delimiter collar 364.
It will be appreciated by persons skilled in the art that, optionally, assembly of portions of system 200 may be performed in a different order, with the final assembly being identical to that arrived at according to the assembly procedure indicated above. Optionally, assembly of some of the components such as, for example, the locking element, may be omitted, if desired.
Operation of system 200 will be described with reference to components of the system discussed hereinabove. It may be noted that the system has three operating positions, namely, retracted, neutral, and advanced, and transition between these operating positions is actuated, in the embodiment shown, by rotation of roller 212, for example, as discussed hereinbelow. In the retracted position, pusher element 230 is retracted to its most proximal position within device 204. In the advanced position, pusher element 230 is advanced to its most distal position within device 204, and may, optionally, extend partly 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.
Reference is now made to
As noted above, pusher element 230 may be disposed within needle 250 and pusher element may extend into housing 210 such that pusher element proximal end 326 may be disposed in and retained in bore 227 in the distal end 226 (
Handle 202, pusher element 230, needle 250, and cannula 236 are optionally all arranged along a mutual longitudinal axis 209 (
Delimiter 360 may be positioned on the housing distal end 215 such that delimiter hub 362 (
Distal movement of slider 366 optionally affects a corresponding distal movement of cannula 236 relative to needle 250, thereby potentially possibly extending cannula 236 further over the needle which can result in less of needle distal end 254 extending out of the cannula distal end 235. Similarly, proximal movement of slider 366 optionally affects a corresponding proximal movement of cannula relative to needle 250, thereby possibly partially withdrawing the cannula 236 from over the needle 250 which can result in more of the needle distal end 254 extending out of the cannula distal end 235. It should be noted that the penetration depth of needle 250 into a tissue 206 of a patient is optionally limited to the extent to which the needle projects distally with respect to the distal end 235 of cannula 236, because the cannula optionally has a blunt distal end and does not enter into the tissue.
While, in the embodiment shown, system 200 includes roller 212c, it will be understood by persons skilled in the art that any of the exemplary rollers 112a-c may be utilized in the device discussed herein. However, for the sake of simplicity, the ensuing description refers to the roller by reference no. 112, to gripping portion as 384, and to operative portion as 380.
Roller 212 may be rotatably mounted on roller mounting peg 299 (
It is a particular feature of some embodiments of the present invention that, in the initial operative orientation, locking element 342 may be supported against the rack 220, for example, as discussed hereinbelow, which prevents proximal displacement of the rack 220 and, thereby potentially prevents movement of the roller 212 in a counterclockwise direction (toward the needle distal end 254). This may provide a safety feature which may prevent inadvertent or accidental deployment of anchor 270 or anchor 280 from the system 200. In this initial operative orientation, the roller 212 can optionally only be moved in a clockwise direction (away from the needle distal end 254), which may not be intuitive for the user, thereby potentially preventing inadvertent or accidental premature deployment of anchors 270/280.
The rack 220 may be supported by support portions 218a-d between flanges 292a-b of housing inner wall 290 (
Teeth 225 of rack 220 may be engaged with corresponding teeth 382 of roller 212 such that rotation of roller 212 in a clockwise direction optionally affects movement of rack 220 in a distal direction. Conversely, rotation of roller 212 in a counterclockwise direction optionally affects movement of rack 220 in a proximal direction. It may be noted that, in the initial operative orientation, roller 212 may be in a neutral position, as indicated by marking 390N being visible on roller 212, in
In the initial operative orientation shown, locking bar 346 of locking element 342 has been inserted into recess (
In the embodiment shown, system 200 may be provided with a first solid anchor 270 and a second, hollow anchor 280, the first and second anchors optionally having suture material threaded therethrough, for example, as discussed hereinabove with regard to
According to the embodiment shown, for example, in
It may be noted that
Prior to insertion of the needle distal end 254 through tissue 206, a probe is optionally used, for example, of a type known in the art, optionally to measure the thickness of the tissue through which the needle must penetrate. Slider 366 on the delimiter 360 may be advanced or retracted, as desired, until the indicator peg 368 indicates the length of needle distal end 254 which may be insertable through tissue 206. This causes the cannula 236 to be correspondingly advanced or retracted over the needle 250, so that the length of the needle extending out of the cannula is adjusted according to the thickness of the tissue 206 that was measured, as known in the art.
With reference to
Optionally, anchor 270 may close off the opening at the needle distal tip 253 and needle slot 255, so that tissue does not collect in the openings. Optionally, first anchor 270 includes an inclined distal end having a configuration that corresponds to that of the needle distal tip 253.
It should be noted that, in this position, although the first anchor 270 may be disposed at least partly through tissue 206, the first anchor has optionally not yet been deployed from the needle 250 and may be still positioned within the needle 250.
Referring now to
It may be noted that the amount of force required to rotate the roller 212 in a clockwise direction, from the neutral position (
Deployment of first anchor 270 may be actuated by rotation of the roller 212 in a clockwise direction, from a neutral position, in which marking 390N may be visible on roller 212 (
It may be noted that, during deployment of the first anchor 270, the proximal end 272 of the first anchor is at a location distal to the second anchor 280.
As noted above, clockwise rotation of roller 212 can optionally affect a corresponding movement of the rack 220 in a distal direction. As the rack 220 moves distally, from the position shown in
It may be noted that, while in the embodiment shown in
As noted above, as the roller 212 is rotated in a clockwise direction, the rack 220 begins to move distally, e.g., from the position shown in
It may be noted that, once the roller 212 has been rotated clockwise, to the position shown in
With particular reference to
After deployment of the first anchor 270, the proximal end 284 of the second anchor 280 is optionally more distally spaced apart from distally facing surface 262 of the anchor stopper 260 than in the initial operative orientation (
Reference is now made to
It should be noted that, even in the most retracted position of the pusher element 230, the pusher element proximal end 326 remains within the housing 210. Optionally and alternatively, pusher element 230 may extend proximally out of the housing, for example, up to 5 cm or more than 5 cm.
As noted above, counterclockwise rotation of roller 212 optionally affects a corresponding movement of the rack 220 in a proximal direction. As the rack 220 moves proximally, from the position shown in
It is a further particular feature of some embodiments of the present invention that in this retraction operative orientation, the locking element 342 remains disengaged from the rack 220, and does not prevent further advancement or retraction of the pusher element 230. However, roller 212 may be prevented from rotating further in a counterclockwise direction due to the proximal end 224 of rack 220 abutting a stop 293b provided on housing 210. As rack 220 cannot move further proximally, this optionally prevents further rotation of roller 212 in a counterclockwise direction, due to the engagement of teeth 225 of the rack 220 with teeth 382 of the roller 212.
It is seen in
It is a particular feature of some embodiments of the present invention that, during proximal retraction of the pusher 230, from the position in
It is seen in
With reference to
It is seen in
It should be noted that, for example, as described above with regard to
Optionally, it may be desired to implant second anchor 280 at the same location on tissue 206, using an anchor configuration known in the art as a “vertical mattress.” In this case, needle 250 may be reinserted into tissue 206 at the same location as that at which it was inserted for deployment of first anchor 270. Alternatively, it may be desired to implant second anchor 280 at a different location from that at which first anchor 270 was deployed, using an anchor configuration known in the art as “horizontal mattress.” In this case, needle 250 may be inserted into tissue 206 at a different location from that at which it was inserted for deployment of first anchor 270. According to the embodiment described below with reference to
With reference to
Reference is now made to
Clockwise rotation of the roller 212 optionally affected distal movement of the rack 220, due to the engagement of roller teeth 382 with teeth 225 on rack 220, for example, as discussed herein with regard to
As noted above, with regard to deployment of first anchor 270, movement of components within device 204 may optionally cause an audible indication such as, for example, a double clicking sound, and/or a tactile indication, which informs a user that the second anchor 280 has been deployed. Optionally and/or alternatively, an electronic circuit may be provided to indicate to the user that the second anchor 280 has been deployed. It is a further particular feature of some embodiments of the present invention that in this second anchor deployment operative orientation, the locking element 342 remains disengaged from the rack 220. However, from the position of roller shown in
It is seen in
With regard to
With reference to
It should be noted that, in this configuration, the suture portions 288a-c which are attached to the first and second anchors, have been released from the device and may extend through tissue 206 to its proximal side. Although suture portions 288a-c appear in
With reference to
While in the embodiment shown, anchors 270 and 280 optionally appear as being generally u-shaped, alternatively, the anchors may each appear as straight or slightly curved into a c-shape, depending, for example, on the rigidity of the anchors and how tightly the anchors are pulled by the suture material.
In order to tightly fasten the anchors 270 and 280 against tissue 206, the long suture portion 288b may be pulled. This shortens the small loop 288a, which causes each of the anchors to assume a narrow u-shape and to be tightened against tissue 206, as shown in
In accordance with an alternative embodiment, both a first anchor and a second anchor may be loaded together in parallel into a sheath, and each of the anchors may be optionally covered by a resilient cover. Both anchors may be loaded together into a single needle and a driving 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.
Yet further, in accordance with another alternative embodiment, the system may include more than two anchors. For example, there may be provided a single solid anchor, deployable, for example, as described above with regard to
Optionally, the anchors in accordance with any of the described embodiments may or may not be attached by suture material. It is noted that the system 200 may be configured to be disposable.
With reference to
With reference to
It should be noted that the device may be operated outside the body, for example, in accordance with the actions indicated above, and/or not during a medical procedure, such as, for example, during testing of the device.
It is expected that during the life of a patent maturing from this application many relevant anchoring systems will be developed and the scope of the term anchor is intended to include all such new technologies a priori.
As used herein the term “about” refers to ±10%.
The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”.
The term “consisting of” means “including and limited to”.
The term “consisting essentially of” means that the composition, method or structure may include additional ingredients, steps and/or parts, but only if the additional ingredients, steps and/or parts do not materially alter the basic and novel characteristics of the claimed composition, method or structure.
As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.
Throughout this application, various embodiments of this 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 invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
Although 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, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall 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.
This application claims priority from U.S. Provisional Patent Application No. 62/591,132 to Alfia et al., filed on Nov. 27, 2017, the contents of which are hereby incorporated herein by reference in their entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/IL2018/051298 | 10/27/2018 | WO | 00 |
Number | Date | Country | |
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62591132 | Nov 2017 | US |