# Patent

## Title
Lock bar spring and clip for implant deployment device

## Abstract

A system for closing an aperture in a biological tissue includes an implant deployment device having a frame arm, a clip connected to the frame arm, and a lock bar including a protrusion. The protrusion extends away from the frame arm and is configured for selectively holding the clip in an open position or a closed position. A surgical implant is releasably attached to the frame arm. The clip retains the surgical implant in contact with the frame arm when the clip is in the closed position and the clip allows the surgical implant to be separated from the frame arm when the clip is in the open position.

## Background
CROSS-REFERENCE TO RELATED APPLICATIONS
The present application is a continuation-in-part of U.S. patent application Ser. No. 12/891,962, filed on Sep. 28, 2010, now U.S. Pat. No. 8,758,373, which is a continuation-in-part of U.S. patent application Ser. No. 12/834,456, filed Jul. 12, 2010, now U.S. Pat. No. 8,753,359, which is a continuation-in-part of PCT international patent application number PCT/IL2009/000188, filed Feb. 18, 2009, which claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/029,386, filed Feb. 18, 2008. The present application also claims the benefit of and priority to U.S. provisional patent application Ser. No. 61/302,186, filed Feb. 8, 2010. The contents of each of these prior applications are incorporated by reference herein in their entirety.


FIELD OF THE INVENTION
This invention generally relates to a device and method for reversibly coupling an implant to an implant deployment device.
BACKGROUND
An object of the present invention is to provide an apparatus and a method for performing corrective surgery on internal wounds such as a hernia where invasion of the patient's body tissues is minimized and resultant trauma is reduced.
A hernia is a protrusion of a tissue, structure, or part of an organ through the muscular tissue or the membrane by which it is normally contained. In other words, a hernia is a defect in the abdominal wall through which a portion of the intra-abdominal contents can protrude. This often causes discomfort and an unsightly, visible bulge in the abdomen. When such a hernia defect occurs in the abdominal region, conventional corrective surgery has required opening the abdominal cavity by surgical incision through the major abdominal muscles. While this technique provides for effective corrective surgery of the hernia defect, it has the disadvantage of requiring a hospital stay of as much as a week, during which pain is frequently intense, and it requires an extended period of recuperation. After the conventional surgery, patients frequently cannot return to a full range of activity and work schedule for a month or more. Accordingly, medical science has sought alternative techniques that are less traumatic to the patient and provide for more rapid recovery.
Laparoscopy is the science of introducing a viewing instrument through a port into a patient's body, typically the abdominal cavity, to view its contents. This technique has been used for diagnostic purposes for more than 75 years. Operative laparoscopy is performed through tiny openings in the abdominal wall called ports. In most surgical techniques, several ports, frequently three to six, are used. Through one port is inserted the viewing device, which conventionally comprises a fiber optic rod or bundle having a video camera affixed to the outer end to receive and display images from inside the body. The various surgical instruments are inserted through other ports to do the surgery that normally would be performed through an open incision through the abdominal wall. Because the laparoscopic surgical techniques require only very small holes through the abdominal wall or other portions of the body, a patient undergoing such surgery may frequently leave the hospital within one day after the surgery and resume a full range of normal activities within a few days thereafter.
In repairing hernia the physician needs to first deploy the implant and then attach the implant to the tissue.
There are many patents and patent applications relating to attaching a prosthesis implant to a tissue via tacks. Each patent and patent application describes a different attachment mechanism via different anchoring means (see for example U.S. Pat. No. 6,447,524). Traditional anchors used in surgery include clips, staples, or sutures, and may also be referred to as tissue anchors. These devices are usually made of a biocompatible material (or are coated with a biocompatible material), so that they can be safely implanted into the body.
Most tissue anchors secure the tissue by impaling it with one or more posts or legs that are bent or crimped to lock the tissue into position. Thus, most traditional anchors are rigid or are inflexibly attached to the tissue. For example PCT No. WO 07/021834 describes an anchor having two curved legs that cross in a single turning direction to form a loop. Those two curved legs are adapted to penetrate tissue in a curved pathway. U.S. Pat. No. 4,485,816 describes surgical staple made of shape memory alloy. The staple is placed in contact of the tissue and then heated. The heating causes the staple to change its shape thus, penetrating the tissue.
U.S. Pat. No. 6,893,452 describes a tissue attachment device that facilitates wound healing by holding soft tissue together under improved distribution of tension and with minimal disruption of the wound interface and its nutrient supplies.
U.S. Pat. No. 6,517,584 describes a hernia implant which includes at least one anchoring device made of shape memory material. The anchoring devices are initially secured to the prosthesis by being interlaced through a web mesh constituting the prosthesis. The attachment is obtained by altering the attachment element's shape from rectilinear to a loop shape due to heat induced shape memory effect.
Yet other patent literature relates to devices for endoscopic application of surgical staples adapted to attach surgical mesh to a body tissue.
An example of such a teaching is to be found in U.S. Pat. No. 5,364,004; U.S. Pat. No. 5,662,662; U.S. Pat. No. 5,634,584; U.S. Pat. No. 5,560,224; U.S. Pat. No. 5,588,581; and in U.S. Pat. No. 5,626,587.
There are a few patent and patent applications teaching the deployment of implants. For example U.S. Pat. No. 5,836,961 which relates to an apparatus used for developing an anatomic space for laparoscopic hernia repair and an implant for use therewith. The apparatus of U.S. Pat. No. 5,836,961 comprises a tubular introducer member having a bore extending therethrough. A tunneling shaft is slidably mounted in the bore and has proximal and distal extremities including a bullet-shaped tip. A rounded tunneling member is mounted on the distal extremity of the tunneling shaft. The apparatus comprises an inflatable balloon. Means is provided on the balloon for removably securing the balloon to the tunneling shaft. Means is also provided for forming a balloon inflation lumen for inflating the balloon. The balloon is wrapped on the tunneling shaft. A sleeve substantially encloses the balloon and is carried by the tunneling shaft. The sleeve is provided with a weakened region extending longitudinally thereof, permitting the sleeve to be removed whereby the balloon can be unwrapped and inflated so that it lies generally in a plane. The balloon as it is being inflated creates forces generally perpendicular to the plane of the balloon to cause pulling apart of the tissue along a natural plane to provide the anatomic space.
More patent literature can be found in PCT No. WO 08/065653 which relates to a device especially adapted to deploy an implant within a body cavity. The device is an elongate open-bored applicator and comprises (a) at least one inflatable contour-balloon, (b) at least one inflatable dissection balloon. The inflatable contour-balloon and the inflatable dissection balloon are adjustable and located at the distal portion. The elongate open-bored applicator additionally comprises (c) at least one actuating means located at the proximal portion. The actuating means is in communication with the inflatable contour-balloon and the inflatable dissection balloon. The actuating means is adapted to provide the inflatable contour-balloon and the inflatable dissection balloon with independent activation and/or de-activation.
Although all the above described patents and patent applications demonstrate attachment means or deployment means, none of the literature found relates to a reversible connection device which enable a reversible coupling between the implant and the implant deployment device.
Thus, there is still a long felt need for a device that will enable a reversible connection between the implant and the implant deployment device.
SUMMARY
It is one object of the present invention to provide an active reversible connection mechanism adapted to provide a reversible attachment between a prosthetic implant and an implant deployment device, wherein said attachment can be actively reversed without requiring any application of force on said implant.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said active reversible connection mechanism comprising at least one clip, hinge-like coupled to said implant deployment device, adapted to attach said implant to said implant deployment device: Said clip is characterized by having at least three configurations: (i) a horizontal configuration in which said clip is substantially horizontal with respect to said implant deployment device; (ii) a vertical configuration in which said clip is substantially vertical with respect to said implant deployment device; and, (iii) a free motion configuration in which said clip is free to rotate; such that (i) when said clip is in said horizontal configuration said attachment between said implant and said implant deployment device is obtained; (ii) when said clip is in said free motion configuration said detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, additionally comprising at least one locking bar characterized by at least two configurations: (i) lock configuration in which said lock bar maintains said clip in said horizontal configuration; and, (ii) free configuration in which said locking bar enables said clip a free movement.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said active reversible connection additionally comprising at least one detachment actuator adapted to reversibly transform said locking bar from said lock configuration to said free configuration.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said attachment between said implant and said implant deployment device is obtained once said locking bar is in its said lock configuration and said at least one clip is in said horizontal configuration such that the same at least partially penetrates said implant.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said detachment is achieved by transforming said locking bar from said lock configuration to said free configuration via said at least one detachment actuator.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said detachment actuator comprises a wire; further wherein said wire is attached to said lock bar.
It is another object of the present invention to provide the active reversible connection mechanism as defined above, wherein said transformation of said clip from said vertical configuration into their said horizontal configuration is performed manually by the physician or by the aid of a dedicated device.
It is another object of the present invention to provide a method for attaching a prosthetic implant to an implant deployment device. The method comprising steps selected, inter alia, from:
a. obtaining an active reversible connection mechanism adapted to provide a reversible attachment between said prosthetic implant and said implant deployment device; wherein said attachment can be actively reversed without requiring any application of force on said implant; said active reversible connection comprising
i. at least one clip, hinge-like coupled to said implant deployment device, adapted to attach said implant to said implant deployment device: Said clip is characterized by having at least three configurations: (i) horizontal configuration in which said clip is substantially horizontal with respect to said implant deployment device; (ii) a vertical configuration in which said clip is substantially vertical with respect to said implant deployment device; and, (iii) a free motion configuration in which said clip is free to rotate;
ii. at least one locking bar characterized by at least two configurations: (i) lock configuration in which said lock bar maintains said clip in said horizontal configuration; and, (ii) free configuration in which said locking bar enables said clip a free movement; and,
b. providing said clips in said vertical configuration;
c. providing said locking bar in said lock configuration;
d. threading said implant through said clip;
e. transforming said clip into its said horizontal configuration thereby providing said attachment between said implant and said implant deployment device;
It is another object of the present invention to provide the method as defined above, additionally comprising the step of providing said active reversible connection with at least one detachment actuator.
It is another object of the present invention to provide the method as defined above, additionally comprising the step of reversibly transforming said locking bar from said lock configuration to said free configuration via said detachment actuator; thereby enabling free rotation of said clip such that detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide the method as defined above, additionally comprising the step of introducing said implant deployment device into a body cavity.
It is another object of the present invention to provide the method as defined above, additionally comprising the step of detaching said implant from said implant deployment device.
It is another object of the present invention to provide the method as defined above, wherein said detachment additionally comprising the steps of reversibly transforming said locking bar from said lock configuration to said free configuration via said detachment actuator; thereby enabling said clip to rotate freely such that said detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide a hernia kit useful in minimal invasive hernia surgery, comprising:
a. an implant;
b. an implant deployment device, adapted to deploy said implant within the abdominal cavity; and,
c. an active reversible connection mechanism for reversible attaching said implant to said implant deployment device;
wherein attachment can be actively reversed without requiring any application of force on said implant.
It is another object of the present invention to provide the hernia kit as defined above, wherein said active reversible connection mechanism comprising:
a. at least one clip, hinge-like coupled to said implant deployment device, adapted to attach said implant to said implant deployment device: Said clip is characterized by having at least three configurations: (i) horizontal configuration in which said clip is substantially horizontal with respect to said implant deployment device; (ii) a vertical configuration in which said clip is substantially vertical with respect to said implant deployment device; and, (iii) a free motion configuration in which said clip is free to rotate; such that (i) when said clip is in said horizontal configuration said attachment between said implant and said implant deployment device is obtained; (ii) when said clip is in said free motion configuration said detachment between said implant and said implant deployment device is obtained.
It is another object of the present invention to provide the hernia kit as defined above, additionally comprising at least one locking bar characterized by at least two configurations: (i) lock configuration in which said lock bar maintains said clip in said horizontal configuration; and, (ii) free configuration in which said locking bar enables said clip a free movement.
It is another object of the present invention to provide the hernia kit as defined above, wherein said active reversible connection additionally comprising at least one detachment actuator adapted to reversibly transform said locking bar from said lock configuration to said free configuration.
It is another object of the present invention to provide the hernia kit as defined above, wherein said attachment between said implant and said implant deployment device is obtained once said locking bar is in its said lock configuration and said at least one clip is in said horizontal configuration such that the same at least partially penetrates said implant.
It is another object of the present invention to provide the hernia kit as defined above, wherein said detachment is achieved by transforming said locking bar from said lock configuration to said free configuration via said at least one detachment actuator.
It is still an object of the present invention to provide the hernia kit as defined above, wherein said detachment actuator comprises a wire; further wherein said wire is attached to said lock bar.
It is an object of the present invention to provide the hernia kit as defined above, wherein said transformation of said clip from said vertical configuration into their said horizontal configuration is performed manually by the physician or by the aid of a dedicated device.
At least one aspect of this disclosure includes a system for closing an aperture in a biological tissue, the system including a proximal portion adapted to remain outside a patient body, a distal portion adapted to be inserted into a patient body, the distal portion including at least one frame arm, at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the frame arm, and a lock bar including at least one protrusion, the at least one protrusion extending away from the at least one frame arm, wherein the at least one protrusion is configured to selectively hold the at least one clip in at least one of an open position or a closed position.
In at least one aspect of the present disclosure, the at least one protrusion selectively engages the at least one clip to lock the at least one clip in a closed position by inhibiting movement or rotation of the at least one clip when the lock bar is in a locked position, and wherein the lock bar allows the at least one clip to move or rotate to an open position when the lock bar is in an unlocked position.
In at least one aspect of the present disclosure, the at least one protrusion selectively engages the at least one clip to lock the at least one clip in an initial open position by inhibiting movement or rotation of the at least one clip when the lock bar is in a locked position, wherein the at least one protrusion is shaped to allow the at least one clip to deflect the at least one protrusion inwardly towards the frame arm, thereby allowing the at least one clip to rotate over the at least one protrusion from the initial open position to a closed position.
In at least one aspect of the present disclosure, the force applied against the protrusion as the clip rotates from the open position to the closed position is greater than a spring constant of the at least one protrusion. Thus, the protrusion deflects inwards as the clip rotates past the protrusion.
In at least one aspect of the present disclosure, a lock bar for a system for closing an aperture in a biological tissue includes a body portion and at least one protrusion, the at least one protrusion extending away from the at least one frame arm, wherein the at least one protrusion is configured to selectively hold the at least one clip in at least one of an open position or a closed position.
In at least one aspect of the present disclosure, the lock bar includes two protrusions configured in a mirror-like arrangement to operate with a pair of clips.
In at least one aspect of the present disclosure, the at least one protrusion selectively engages the at least one clip to lock the at least one clip in an initial open position by inhibiting movement or rotation of the at least one clip when the lock bar is in a locked position, wherein the at least one protrusion is shaped to allow the at least one clip to deflect the at least one protrusion inwardly towards the frame arm, thereby allowing the at least one clip to rotate over the at least one protrusion from the initial open position to a closed position.
In at least one aspect of the present disclosure, the lock bar is formed from nitinol.
In at least one aspect of the present disclosure, a method includes providing a system for closing an aperture in a biological tissue, the system including a proximal portion adapted to remain outside a patient body, a distal portion adapted to be inserted into a patient body, the distal portion including at least one frame arm, at least one clip connected to the at least one frame arm and configured to releasably retain a surgical implant to the frame arm, and a lock bar including at least one protrusion, the at least one protrusion extending away from the at least one frame arm, wherein the at least one protrusion is configured to selectively hold the at least one clip in at least one of an open position or a closed position, and releasably attaching the surgical implant to the at least one clip.
In at least one aspect of the present disclosure, the at least one protrusion selectively engages the at least one clip to lock the at least one clip in a closed position by inhibiting movement or rotation of the at least one clip when the lock bar is in a locked position, and wherein the lock bar allows the at least one clip to move or rotate to an open position when the lock bar is in an unlocked position.
In at least one aspect of the present disclosure, the at least one protrusion selectively engages the at least one clip to lock the at least one clip in an initial open position by inhibiting movement or rotation of the at least one clip when the lock bar is in a locked position, wherein the at least one protrusion is shaped to allow the at least one clip to deflect the at least one protrusion inwardly towards the frame arm, thereby allowing the at least one clip to rotate over the at least one protrusion from the initial open position to a closed position.
In at least one aspect of the present disclosure, the force applied against the protrusion as the clip rotates from the open position to the closed position is greater than a spring constant of the at least one protrusion. Thus, the protrusion deflects inwards as the clip rotates past the protrusion.
In at least one aspect of the present disclosure, the system is provided in the initial open position for facilitating installation of an implant.
In at least one aspect of the present disclosure, the method further includes moving the clips from the initial open position to the closed position after attaching an implant to the clips.
In at least one aspect of the present disclosure, the method further includes inserting the system into a patient body after moving the clips from the initial open position to a closed position.
In at least one aspect of the present disclosure, the method further includes moving the lock bar to an unlocked position after inserting the system into a patient body.
In at least one aspect of the present disclosure, the method further includes moving the clips to an open position after moving the lock bar to an unlocked position.
In at least one aspect of the present disclosure, the method further includes releasing the implant from the clips at a target site inside a patient body.
In at least one aspect of the present disclosure, the method further includes allowing the clips to return to the closed position after the releasing step.
In at least one aspect of the present disclosure, the method further includes removing the system from the patient body after the allowing step.



BRIEF DESCRIPTION OF THE DRAWINGS
The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:
FIG. 1A illustrates an example of an implant deployment device which comprises said active reversible connection mechanism;
FIGS. 2A-2D illustrate the internal operation of said active reversible connection mechanism;
FIGS. 3A-3E illustrate a method of using said active reversible connection mechanism for providing said reversible connection between said implant and said implant deployment device;
FIG. 4A-4H illustrate an embodiment of a stapling apparatus adapted for providing a reversible connection by the active reversible connection mechanism;
FIG. 5 illustrates an embodiment of a staple return spring;
FIG. 6 is a side perspective view of a lock bar in accordance with the present disclosure;
FIG. 7A is a side perspective view of an embodiment of a clip locking system in a closed and unlocked position in accordance with the present disclosure;
FIG. 7B is a side perspective view of FIG. 7A showing the clip locking system in an open and locked position in accordance with the present disclosure;
FIG. 7C is a side perspective view of the embodiment of FIG. 7A showing the clip locking system in a closed and locked position in accordance with the present disclosure;
FIG. 8A is a side view of an embodiment of a clip locking system in an open and unlocked position prior to attaching an implant in accordance with the present disclosure;
FIG. 8B is a side view of the embodiment of FIG. 8A in an open and unlocked position having an implant attached thereto in accordance with the present disclosure; and
FIG. 8C is a side view of the embodiment of FIG. 8A in a closed and locked position with the implant attached thereto in accordance with the present disclosure.



DETAIL DESCRIPTION OF THE SPECIFIC EMBODIMENTS
The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications of the present disclosure should be apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide means and method for creating a reversible and active connection between an implant and an implant deployment device.
The present invention provides an active reversible connection mechanism between a prosthetic implant and an implant deployment device wherein said connection can be performed during a surgery at a standard surgery room by the medical staff
Furthermore, the present invention provides means so as to enable the surgeon to actively eliminate said attachment once detachment between said implant deployment device and said implant is necessary.
It should be emphasized that some of the major advantages of the present invention, with respect to the prior art, is to provide a fast and intuitive method for creating a reliable connection between an implant and an implant deployment device in the surgery room. Embodiments of an implant include, but are not limited to, a surgical patch, a surgical mesh, or other biocompatible implants usable in repairing a defect in body tissue.
In addition, the present invention provides means to actively disconnect said implant from said implant deployment device, when said disconnection is desired without the need to exert large forces on said implant and/or said tissue.
The term “Hernia” refers hereinafter for umbilical hernia, hiatal hernia, ventral hernia, postoperative hernia, epigastric hernia, spiegelian hernia, inguinal hernia and femoral hernia, generally any abdominal wall related hernia.
The term “hinge” or “hinge-like connection” refers hereinafter as to a type of bearing that connects two solid objects, typically allowing only a limited angle of rotation between them. Two objects connected by an ideal hinge rotate relative to each other about a fixed axis of rotation (the geometrical axis of the hinge). Hinges may be made of flexible material or of moving components.
The term “hinge like connection” can refer to a standard hinge or to a living hinge (i.e., a thin flexible hinge (flexure bearing) made from plastic that joins two rigid parts together while allowing them to bend along the line of the hinge).
The term “controlled deployment” refers hereinafter to an implant deployment which is continuous. Thus, deployment using the presently disclosed implant deployment device is variable amongst a number of deployment levels between a fully opened position and a fully closed position rather than a binary arrangement that does not include any intermediate positions or levels between fully opened and fully closed. This is in contrast to some conventional deployment systems in which the deployment of the implant relies upon the elasticity of a loop member surrounding the implant such that the implant can be either fully folded or fully unfolded. No intermediate stages are enabled. In the present invention, there can be several deployment stages.
The term “bidirectional” or “fully reversible deployment” refers hereinafter to the deployment of the implant, which according to the present invention, is fully reversible. In other words, the implant deployment is bidirectional, i.e., the implant can be fully folded (i.e., deployed within the body) and then, if the surgeon desires, the implant can be fully unfolded simply by the reconfiguration of the flexible arms from the initial stage to the final stage and vice versa.
The term “minimally invasive surgery” refers hereinafter to procedures that avoid open invasive surgery in favor of closed or local surgery with fewer traumas. Furthermore, the term refers to a procedure that is carried out by entering the body through the skin or through a body cavity or anatomical opening, but with the smallest damage possible.
The term “articulation” refers hereinafter to a joint or juncture between two segments of the device. The articulating means of the present invention provides the ability to better adjust the device to the curvature of the treated tissue.
The term “orientation” refers hereinafter to the rotation of the mesh within the abdominal cavity so as to fit to the hernia. Usually the mesh is not symmetric in shape (e.g., rectangular or elliptical)—therefore it has different directions. By rotating the mesh within the abdominal cavity—one can decide which direction is turned where.
The term “adjusting” refers hereinafter to rolling, folding, and winding of the implant, thus preparing and enabling the insertion of said implant into the abdominal cavity.
The term “active reversible connection” refers hereinafter to a coupling between the implant and the implant deployment device implant deployment device in which the coupling/decoupling between the implant and the implant deployment device is enabled by an act performed by the user (namely the physician). Once said user performed said act, said coupling/decoupling is canceled.
According to the present invention the coupling/decoupling is obtained actively via the aid of dedicated clips which are characterized by at least two configurations:
(a) substantially horizontal/parallel configuration (in which an attachment between the implant and the implant deployment device is provided);
(b) substantially vertical configuration; and,
(c) a configuration in which the clips are free to rotate.
Before explaining the figures, it should be understood that the invention is not limited in its application to the details of construction and the arrangement of the components set forth in the following description or illustrated in the drawings. The invention can be carried out in various ways.
Reference is now being made to FIG. 1A illustrates an example of an implant deployment device 100 which comprises said active reversible connection mechanism.
Implant deployment device 100 is defined hereinafter as a surgical device which can introduce a implant into a body cavity of a patient; implant deployment device 100 can deploy said implant such that it is at least partially spared inside the body cavity; alternatively implant deployment device 100 can only introduce said implant into the body cavity without performing any deployment.
In general, implant deployment device 100 comprises at least two portions: a distal portion 101 and a proximal portion 102. The proximal portion is adapted to remain outside the body, adjacently to the user and the distal portion 101 is adapted to be inserted into the body.
The distal portion comprises at least one frame arm 104 to which the implant is attached. Each frame arm 104 comprises said active reversible connection mechanism which provides reversible attachment between each frame arm 104 and the implant 106 such that said implant can be rolled/folded on said distal portion 101, and inserted into the patient's body cavity through a laparoscopic cannula or a small incision.
It should be noted that the term reversible refers hereinafter to the ability to both attach the implant to the implant deployment device and to decouple the same from the implant deployment device.
Said active reversible connection mechanism comprises at least one clip 107. Said clip is coupled to said frame arm 104 by hinge tab 132. Said active reversible connection is covered by cover 131 which is attached to the frame arm 104. Cover 131 comprises at least one hinge tab 132 which is adapted to hold said clip 107 attached to frame arm 104 an to serve as a hinge allowing free rotation of said clip 107. Said hinge tab 132 is inserted through hinge hole 133, located at clip 107 and through hole 134, located at frame arm 104.
Reference is now being made to FIGS. 2A-2D which illustrate the internal operation of said active reversible connection mechanism. For the purpose of illustration only, cover 131 is removed from these drawings.
A locking bar 203 is located inside groove 204 at frame arm 104. Said locking bar 203 can move linearly inside said groove 204 and comprises at least one groove 205. Said locking bar 203 is characterized by at least two positions: free position, in which each of said groove/s 205 is substantially located below said clip 107 (see FIGS. 2C and 2D), and lock position, in which said groove 205 is located away from said clip 107 (see FIGS. 2A and 2B).
In the lock position of the locking bar 203, the clip 107 are substantially perpendicular to the frame arm 104; and in free position of the locking bar 203, the clip 107 are free to rotate (hence, as will be discussed hereinafter a detachment is enabled).
A disconnection wire 206 is attached to said locking bar 203. Said wire 206 can be pulled proximally to the proximal portion 102 and is adapted to transform said locking bar 203 from its said lock position into its said free position.
According to this embodiment, each clip 107 comprises at least 3 sections: protruding portion (PP) 201 adapted to protrude through said implant during said connection process, hinge hole 133, and locking tab 202 which is tilted toward frame arm 104.
Each of said clip 107 is characterized by at least two configurations: horizontal/parallel configuration in which said clip 107 is substantially horizontal and parallel to said frame arm 104 (FIGS. 2B, 2C) and vertical configuration in which said clip 107 is substantially vertical with respect to said frame arm 104 (FIGS. 2A and 2D).
At least one holding hole 207 is located at said locking bar 203 and is adapted to hold said clip 107 in its vertical configuration.
At least one niche 208 in located at frame arm 104 adapted to accommodate said locking tab 202 of said clip 107 while the clip 107 is in its said horizontal/parallel configuration.
Reference is now being made to FIGS. 3A-3D illustrating a method of using said active reversible connection mechanism in order to provide said reversible connection between said implant and said implant deployment device 100. Again, for the purpose of illustration only, cover 131 was removed from these drawings.
FIG. 3A illustrates the initial state of said active reversible connection mechanism in which all of said clip 107 are in their vertical configuration and said locking bar 203 is positioned in said lock position.
As can be seen in the figure, said locking tab 202 of each said clip 107 is located inside said holding hole 207, therefore each clip 107 is held in its said vertical configuration and can penetrate a implant 210 whilst the last is mounted on top of said implant deployment device (see FIG. 3B).
Once said implant is mounted, each of said clip 107 is transformed from said vertical configuration into their said horizontal configuration (see FIG. 3C).
Said transformation can be achieved either manually (i.e., the physician will manually rotate the clips 107 thereby transforming them from said vertical configuration into their said horizontal configuration) or by the aid of a dedicated device.
Once said clip 107 is transformed to its horizontal configuration while said locking bar is in its said lock position, said locking tab 202 is urged into niche 208. Since the locking tab 202 is titled inwardly, if said clip 107 is pulled upwardly in this state, the locking tab 202 is stopped by the upper edge of said locking bar 203, therefore, the rotation back to said vertical configuration of said clip 107 is limited by said locking bar 203 and said clips 107 are locked in said horizontal configuration, holding said implant attached to said frame arm 104.
It should be pointed out that it is a unidirectional mechanism. In other words, if one tries to force clips 107 to its vertical configuration, locking tabs 202 will bump into locking bar 203.
By further pulling said locking bar 203 towards the proximal portion the clips 107 are unlocked and can be rotated be back to its vertical configuration (see FIGS. 3D and 3E).
Once detachment between said implant 210 and said implant deployment device in desired, locking bar 203 is pulled backward by wire 206, changing the position of said locking bar form its said lock position into its said free position (see FIG. 3D). In said free position of the locking bar 203, the clips 107 are free to rotate (hence, as will be discussed hereinafter, a detachment between the implant deployment device and the implant is enabled).
Once locking bar 203 is positioned in said free position, said groove's 205 is located below said clips 107, therefore said locking bar 202 is no longer limiting the movement of said clips 107 enabling their free movement. In this state, detachment can be obtained by simply pulling said frame arm 104 away from said implant; as a result, said clips 107 rotate back into their said vertical configuration and are released from said implant (see FIG. 2E).
Reference is now made to FIG. 4A-4H, which illustrate an embodiment of a stapling apparatus 400 adapted for providing said reversible connection by said active reversible connection mechanism. Said stapling apparatus 400 comprises a frame 401 which holds the distal portion 101 of an implant deployment device 100. Four staplers 403 are connected to the frame 401 at each cornet by four separate hinges (either standard or living hinges). Each said stapler 403 is adapted to push down the implant 210 through a pair of clip 107 and to transform said clips 107 from a vertical position into a horizontal position (thus providing said reversible connection). Stapling presses 404 are located at the end of each stapler inside groove 405 and adapted to push clip 107 into horizontal position. Each pair of staplers 403 is connected via bridge 407 in order to prevent lateral movement of said staplers 403 during the stapling process. A snap groove 406 is located at the center of the frame 401 and adapted to reversibly hold said implant deployment device 100 attached to stapling apparatus 400 until said reversible attachment is obtained.
Each pair of clip 107 is held in a vertical position by clip holder 402. Each said clip holder 402 is adapted to hold a pair of clip 107 in vertical position in order to allow its insertion through the implant 210 during the stapling process. In addition, clip holder 402 is adapted the hold the clips vertical during shipment in order to allow stapling in the operation room without the need of any preparation. As illustrated in FIGS. 4B-4C, each clip holder 402 comprises two grooves 408 which hold the clip 107 in a vertical position. Once stapling process is performed and the surgeon is lowering the stapler 403 toward the implant, each clip holder 402 is pushed down and as a result it is also moving laterally. In this state, since the clip 107 are extracted from groves 408, their transformation from vertical into horizontal position is enabled; said lateral movement of said clip holder 402 is obtained as bulge 409 at clip holder 402 is sliding along bulge 410 at the stapling frame 401 during the down movement of clip holder 402.
FIGS. 4D-4G illustrate the process of connecting the implant 210 to one pair of clip. At the initial stage (FIG. 4D), the clips are held vertically by clip holder 402. Next, an implant 210 is places on top of the stapling apparatus (FIG. 4E); the stapler 403 is then lowered toward the implant 210 by the surgeon (or other member of the medical staff); as a result the two clip 107 are penetrating through implant 210 and into groove 405 (FIG. 4F). During the initial penetration, clip 107 is held by clip holder 402, thus premature transformation from vertical into horizontal position is prevented. Once the clip 107 are completely inserted into said implant 210, clip holder 402 is positioned laterally relative to the clip 107 (as also described is FIGS. 4B-4C); at this stage the surgeon push on stapler press 404 and lower it toward clip 107 (FIG. 4G), as a result clip 107 position is transformed form vertical position into horizontal position. Since the said lock bar 203 is located at its said lock position, once clip 107 are substantially horizontal position, they are locked in this stage, thus providing said reversible connection between implant 210 and implant deployment device 100. Once said connection is obtain with all clip 107, implant deployment device is removed from SA 400.
FIG. 4H illustrates the configuration of stapling apparatus 400 during shipment. In order to reduce package volume during shipment and to keep the device ready for stapling, at least one, preferably two, packaging caps 411 are utilized. Said caps 411 are reversibly attached to the frame 401, and adapted to retain stapler 403 in a substantially horizontal position during device shipment. In addition, said caps 411 also prevent down movement of stapler press 404, prevent lateral movement of clip holder 402 and prevent non-deliberate extraction of implant deployment device 100 from frame 401.
Once the device in removed from its packaging during the surgery, said pack caps 411 are removed by the medical staff in order to allow stapling of the implant 210 to the implant deployment device 100. Once the caps 411 are removed, the staplers 403 springs into horizontal position allowing the placement of implant 210 onto the stapling apparatus 400 and implant deployment device 100.
In order to allow tight spreading of the implant 210 during surgery, said stapling process is preformed while implant deployment device 100 is not completely opened; as a result, once implant deployment device is completely opened inside the abdominal cavity, it is stretched beyond its original dimension (as was during stapling) therefore tight spreading is obtained.
Reference is now being made to FIG. 5 which illustrates an embodiment of a staple return spring 500. In general, staple return spring 500 is needed in order to return clip 107 into horizontal position immediate after detachment from the implant 210; this is necessary in order prevent damage to internal organs by the sharp tip of clip 107 and in order to prevent clip 107 from being caught at the trocar or at the tissue during device extraction.
Referring to FIG. 6, another embodiment of a lock bar 203a for use with an implant deployment device 100 is illustrated. As shown lock bar 203a includes protrusions 601, 603 formed from or attached to lock bar 203a that extend at least partially away from the lock bar 203a in a lateral direction that is away from the frame arm 104. Each protrusion 601, 603 may be a tab of material that is cut out of the lock bar 203a and bent outwardly to create a ramp-like cammed shaped as shown in FIG. 6. Each protrusion 601, 603 may also be a separate piece permanently or releasably attached to the lock bar 203a. 
Each protrusion 601, 603 acts to block rotation of clips 700 when the lock bar 203a is moved to a locked position beneath the clips 700 as shown in FIG. 7C and discussed further below. Also, each protrusion 601, 603 allows for the clips 700 to be assembled in an open position and selectively held in the open position to facilitate attachment of a surgical implant 210 over the clips 700 (FIG. 8B) and against the frame arm 104. Each clip 700 includes a hook 703, a hinge hole 711, a body portion 705, and a locking portion 707. Each clip 700 is rotatably coupled to the frame arm 104 at hinge hole 711. The locking portion 707 is a substantially flat planar surface. Additionally, each clip 700 can be used in any location on the frame arm 104 since the clips 700 are interchangeable with each other. By providing interchangeable clips 700, manufacturing costs are reduced and production of the implant deployment device 100 is simplified.
As herein described with respect to this and future embodiments, an open position is any position where the hooks 703 as herein described are not in contact with or are in close proximity to the frame arm 104, and a closed position is where the hooks 703 are in contact with or are in close proximity to the frame arm 104 to clamp a desired implant. The lock bar 203a may be made from any suitable rigid or semi-rigid material, including, but not limited to nitinol. Referring to FIGS. 7A-7C, the lock bar 203a is shown disposed on a frame arm 104 with the clips 700. As shown in specifically in FIG. 7A, the lock bar 203a is positioned distally in an unlocked position such that protrusions 601, 603 of the lock bar 203a do not engage the locking portions 707 of either clip 700, thereby allowing the clips 700 to be selectively rotated between an open position (FIG. 7B) and a closed position (FIG. 7A). With the lock bar 203a in the unlocked position, the staple return spring 500 urges the clips 700 towards the closed position. The clips 700 are rotatable to the open position as shown in FIG. 7B, which allows the clinician to attach the surgical implant 210 (FIG. 3A) to the frame arm 104 by passing the surgical implant 210 over the hooks 703 of the clips 700. This is the default configuration for the implant deployment device 100 since it allows the clinician to attach the surgical implant 210 to the implant deployment device 100 since the clips 700 are maintained in the open position due to the interaction between the clips 700 and the lock bar 203a in the locked position (FIG. 7B). Once the surgical implant 210 is abutting the frame arm 104, the clips 700 are rotated to the closed position over the protrusions 601, 603 of the lock bar 203a as shown in FIG. 7C. As shown in specifically in FIG. 7C, when the lock bar 203a is in a locked position, the protrusions 601, 603 block each clip 700 from rotating to an open position due to the engagement between top surfaces of the protrusions 601, 603 and the locking portions 707 of each clip 700.
Also shown in FIGS. 7A-7C is the staple return spring 500, as described above, that biases the clips 700 towards a closed position such that when the clips 700 are raised to an open position (FIG. 7B) and the lock bar 203a is in the unlocked position, the staple return spring 500 urges the clips 700 downwards towards a closed position (FIGS. 7A and 7C).
Referring to FIGS. 8A-8C, an implant 210 is shown being attached to clips 700 of the implant deployment device 100. As shown in FIGS. 8A and 8B, the clips 700 are in an initial open position. Due to the cammed surfaces of the protrusions 601, 603, the clips 700 are inhibited from rotating out of the open position. As described above, the protrusions 601, 603 have a cammed shape to allow clips 700 for slidably rotating over the cammed portion of protrusions 601, 603, pushing the protrusions 601, 603 inwardly towards the frame arm 104 to a flexed position. The clips 700 may be rotated out of the open position by the user pressing downwards on the clips 700 either manually or with an instrument (not shown). After rotating the clips 700 over the protrusions 601, 603, the protrusions 601, 603 return to their normal outward configuration and thereafter block the clips 700 from rotating out of the closed position when the lock bar 203a is in the locked position, because top surfaces of the protrusions 601, 603 engage the locking portions 707 of the clips 700 as shown in FIG. 8C. To reset the clips 700 to the initial open position (FIG. 8A), the lock bar 203a is moved to the unlocked position and the clips 700 are rotated to the open position (FIG. 8A).
Utilizing one or more embodiments of the clip and lock bar systems as herein disclosed results in positive engagement between each clip 700 and the lock bar 203a such that the clips 700 are maintained in a closed position (FIGS. 7C & 8C) and securely retain the implant 210 against the frame arm 104 (FIG. 8C). The clips 700 may be initially locked in an open position (FIGS. 8A and 8B) allowing a clinician to position the surgical implant 210 (e.g. a mesh) to the frame arm 104 by passing the surgical implant 210 over the clips 700. After the surgical implant 210 has been attached to the frame arm 104, the user may rotate the clips 700 past the protrusions 601, 603, thereby transitioning the clips 700 to the closed position. With the clips 700 in a closed position, the clips 700 secure the surgical implant 210 against the frame arm 104. When deployment is desired, the clinician places the surgical implant 210 at a desired location in a surgical site and affixes the surgical implant 210 to tissue. Subsequently, the clinician activates a release button (not shown) on the implant deployment device 100, which transitions the lock bar 203a from the locked position (FIG. 7C) to the unlocked position (FIG. 7A). With the lock bar 203a in the unlocked position, the clinician moves the implant deployment device 100 away from the surgical implant 210 that is affixed to tissue. Since the lock bar 203a is in the unlocked position, the clips 700 rotate to the open position as the implant deployment device 100 is moved away from the attached surgical implant 210. Once the implant deployment device 100 is separated from the attached surgical implant 210, the spring member 500 urges the clips 700 towards the closed position. Once the clips 700 are in the closed position, the clinician removes the implant deployment device 100 from the surgical site.
INCORPORATION BY REFERENCE
References and citations to other documents, such as patents, patent applications, patent publications, journals, books, papers, web contents, have been made throughout this disclosure. All such documents are hereby incorporated herein by reference in their entirety for all purposes.
EQUIVALENTS
The invention may be embodied in other specific forms without departing from the spirit or essential characteristics thereof. The foregoing embodiments are therefore to be considered in all respects illustrative rather than limiting on the invention described herein. Scope of the invention is thus indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency of the claims are therefore intended to be embraced therein.

## Claims

1. A surgical instrument comprising:
a proximal portion;
a distal portion including a frame arm;
a clip rotatably coupled to the frame arm and configured to releasably retain a surgical implant to the frame arm; and
a monolithic lock bar including a body and a protrusion, the protrusion extending laterally offset from the body and the frame arm, wherein the protrusion is configured for selectively holding the clip in a predetermined position, wherein the protrusion is shaped to allow the clip to deflect the protrusion inwardly towards the body and towards the frame arm, thereby allowing the clip to rotate over the protrusion from an open position to a closed position.

2. The surgical instrument of claim 1, wherein the protrusion selectively engages the clip to lock the clip in the closed position by inhibiting rotation of the clip when the lock bar is in a locked position and the lock bar allows the clip to rotate to the open position when the lock bar is in an unlocked position.

3. The surgical instrument of claim 1, further including first and second clips rotatably coupled to the frame arm, the first clip having the same configuration as the second clip such that the first and second clips are interchangeable.

4. The surgical instrument of claim 3, wherein the lock bar includes first and second protrusions.

5. The surgical instrument of claim 4, wherein the first and second protrusions engage the first and second clips respectively for maintaining the first and second clips in a predetermined position.

6. The surgical instrument of claim 1, wherein the lock bar is repositionable along a longitudinal axis of the frame arm.

7. A surgical instrument comprising:
a handle;
a shaft extending from the handle;
a frame arm located at a distal end of the shaft;
a clip rotatably coupled to the frame arm, the clip repositionable between an open position and a closed position, the clip configured to releasably retain a surgical implant to the frame arm; and
means for retaining the clip in a predetermined position, wherein the means for retaining the clip is translatable along a longitudinal axis of the frame arm between an unlocked position in which the clip is freely rotatable between the open and closed positions and a locked position in which the clip is rotatable from the open position to the closed position and inhibited from rotating from the closed position to the open position by engagement of the clip and the means for retaining the clips in a predetermined position.

8. The surgical instrument of claim 7, wherein the means for retaining the clip is configured to deflect inwardly when urged by the clip, thereby allowing the clip to rotate.

9. The surgical instrument of claim 7, wherein the means for retaining the clip comprises a lock bar having a laterally extending protrusion.

10. The surgical instrument of claim 9, wherein engagement of the clip and the protrusion inhibits the clip from rotating out of the closed position.

11. The surgical instrument of claim 9, wherein deflection of the protrusion allows the clip to rotate from the open position to the closed position.

12. The surgical instrument of claim 9, wherein the surgical instrument further includes a second clip and the lock bar includes a second protrusion.

13. The surgical instrument of claim 7, wherein the means for retaining the clip engages the clip when the means for retaining the clip is in the locked position.