1. Technical Field
This application generally relates to surgical fasteners and their associated applicators, and more particularly, to surgical fasteners and related applicators for surgically fastening material onto tissue, such as for a hernia repair using mesh.
2. Background of Related Art
Surgical fasteners are used to eliminate the need for suturing, which is often time consuming and inconvenient. Surgical fasteners accomplish in seconds what would have taken many minutes to accomplish by suturing, thus reducing operating time and trauma to the patient. In hernia repair procedures, for example, the weakened area of the abdominal wall may be reinforced with a synthetic mesh. In such an instance, a surgical fastener in the form of an helical fastener may be used, in lieu of, or in addition to, a surgical suture to fix the position of the mesh. may form an apex.
Helical fasteners rotated into tissue are will known in the surgical art. Such fasteners have a threadform in the shape of a helical coil or thread and may have a central reinforcing shaft or a head. Torque may be applied to the faster at the head or by torque transmitting features located either on the outside radial surface of the fastener or head or the inside surface of the fastener in the instance of a cannulated fastener.
In view of the foregoing it can be appreciated that a need exists for improved surgical fasteners and related instruments for their application.
The present disclosure is directed to a surgical fastener for delivery into body tissue during a surgical procedure. The surgical fastener includes a helical fastener having a proximal end and a distal end. The threadform of the helical fastener may be a coil or thread having a cross-section with at least three sides and preferably five sides. Throughout this specification, aspects of a first embodiment discussed as a coil may be extended to a second embodiment having a thread and vice versa.
A first helical coil section is located at the distal end. A tapered point extends from the first helical coil. A central passage that passes through the center of the fastener has a non-circular shape. The central passage defines a longitudinal axis. The continuous helical coil has a profile transverse to the longitudinal axis. The profile is non-circular and may be tri-lobal. A tail is located at the proximal end of the continuous helical coil. The tail may incorporate a feature to entrap and restrain the mesh against tissue.
The non-circular central passage may have a shape in the form of either a D, oval, elliptical, square, triangular, or another polygonal shape.
The head includes an angle Θ as defined by a leading face of the head and a proximal surface of the cross-section. The leading face of the fastener has a triangular shape. The angle Θ is greater than 50°. The tail includes an angle Φ as defined by a trailing face of the tail and a proximal surface of the cross-section. The angle Φ is greater than 110°.
The cross-section has at least a top side and a bottom side that are substantially parallel. The cross-section has a perpendicular side that is substantially perpendicular to the parallel first and bottom sides. The cross-section has a leading side that forms an angle Ω with the longitudinal axis and a trailing side that forms angle Σ with the longitudinal axis. Both angle Ω and angle Σ are internal angles formed by the triangle defined by the leading side, the trailing side, and the longitudinal axis. The angle Ω is typically less than the angle Σ, although the possible ranges of angles Ω and Σ may overlap. Angle Σ may approach 90°, allowing for a small molding draft angle.
The accompanying drawings, which are incorporated in and form part of the specification, illustrate the present disclosure when viewed with reference to the description, wherein:
Other features of the present disclosure will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principles of the present disclosure.
Embodiments of the presently disclosed fastener and fastener application for delivering the fastener into body tissue during a surgical procedure are described in detail with reference to the drawings, in which like reference numerals designate identical or corresponding elements in each of the several views. As used herein, the term “distal” refers to that portion of the surgical suture instrument, or component thereof, farther from the user while the term “proximal” refers to that portion of that portion of the surgical stapler or component thereof, closer to the user.
As is shown in the drawings, which are included for purposes of illustration and not by way of limitation, a continuous helical fastener and an applicator therefore are disclosed. The helical fastener has a high retentive surface area and the applicator has a simple design and functions to dispense the helical fasteners, without substantially deforming the fasteners, into body tissue, access to which is from one direction only.
Referring now to the drawings, wherein like reference numerals identify identical or similar structural elements of the subject device throughout the several views, there is illustrated in
The fastener 10 is formed into the configuration of a continuous helix and, as seen in
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The cross-section helical coil 40 has a leading surface 52 that forms an angle Ω with the longitudinal axis “x” and a trailing surface 54 that forms angle Σ with the longitudinal “X” axis. Both angle Ω and angle Σ are internal angles formed by the triangle defined by the leading surface 52, the trailing surface 54, and the longitudinal “X” axis. The angle Ω is less than the angle Σ. The angle Ω is about 60° and the angle Σ is about 85°, but can approach 90° with allowance for a molding draft angle.
Leading surface 52 and trailing surface 54 meet in a tapered point consisting of leading tip surface 52′ and trailing tip surface 54′. Leading tip surface 52′ is the outer most extension of leading surface 52, and trailing tip surface 54′ is the outer most extension of the trailing surface 54. Leading tip surface 52′ and trailing tip surface 54′ form respective angles Ω′ and angle Σ′ with the longitudinal “X” axis. Angles Ω′ and angle Σ′ are respectively less than angles Ω and angle Σ.
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It is contemplated that the fastener be made from a metal, a plastic, or an absorbable material. Examples of materials that can be used in constructing the helical fastener 10 include titanium, titanium alloys, stainless steel, nickel, chrome alloys and any other biocompatible implantable metals. Other options for materials are liquid crystal polymers, HDPE, polyglycolic acid, and polyglycolid hydroxgacetic acid. Further, it may also be desirable to coat the fastener, or a portion thereof, with a biocompatible lubricious material that provides for easier delivery of the fastener into tissue. Various combinations of materials, such as polymer alloys and or coatings are contemplated.
With reference to
With continued reference to
The distal portion 134 includes an outer tube 136 housing a drive rod 138. It is to be appreciated that the drive rod 138 may receive a single fastener or a plurality of fasteners.
Turning to
In order to eject surgical fasteners from the distal portion 134, the actuator 132 functions to turn the drive rod 138. As the rotator turns, the distal end 21 of a fastener is threaded out of the threads 148 of the applicator 100.
A lever 154 is pivotally connected about a midpoint 156 to the handle 130. A first end 158 of the lever 154 is to be configured for gripping by hand. A second end 160 of the lever is to be adapted to pivotally engage a nut driver 162.
The nut driver 162 of the applicator 100 travels upon a high helix lead screw 164, which is rotatably mounted within the proximal portion 128. As shown, a longitudinal axis of the high helix lead screw 164 is coaxial with the longitudinal axis “x” extending through the distal portion 134 of the applicator 100. Upon manipulation of the lever 154, the nut driver 162 travels along the lead screw 164 causing it to rotate through a connection of the lead screw 164 to the drive rod 138. The action of the lead screw 164 causes the rotator to rotate. The lead screw 164 may be connected to the drive rod 138 by any conventional means. For instance, the lead screw 164 can have an internal bore receiving and engaging an end of the drive rod 138. Further, the length of travel of the nut driver 162 along the lead screw 164 is chosen such that it causes the rotator to rotate a predetermined number of times so that a single helical fastener 10 is ejected from the applicator 100.
Additionally, as shown, the lever further comprises a midsection extension 166. Pivotally attached to the midsection extension 166 of the lever 154 is contemplated to be a spring loaded pawl 168 adapted to releasably engage gear teeth 170 formed in the interior of the handle 130. Spring loaded pawl 168 is configured to prohibit the lever 154 from backstroking until it has been completely depressed. Upon complete depression of the lever 154, the pawl 168 clears the gear teeth 170 and the spring biasing the pawl 168 rotates the pawl 168 away from the teeth 170, thereby allowing the lever 154 to return to its undepressed condition.
In operation, upon complete depression of the lever 154, the nut driver 162 travels a pre-determined distance along the lead screw 164, causing the drive rod 138 to rotate a pre-determined number of revolutions corresponding to a number of turns of a particular helical fastener 10. As the drive rod 138 rotates, the fasteners 10 retained by the rotator also rotate and the coils of the most distal fastener 10 are threaded out of the terminal end 146 of the applicator 100 and into tissue. Moreover, where the lever 154 is only partially depressed, the spring loaded pawl 168 operates to hold the lever 154 stationery and will continue to function to hold the lever 154 stationery until the lever 154 has been completely depressed. In this way, the delivery of fasteners into body tissue is controlled so that only a single fastener may be completely ejected out of the applicator 100 and pressed into body tissue at a time.
As shown, the proximal portion 128 is fabricated to have a reusable handle that can be re-sterilized, and the distal portion is made disposable. Thus, upon discharge of all the fasteners 10 from distal portion 134, the distal portion would be discarded and replaced. The handle could be reused up to a limited number of procedures.
With reference to
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From the foregoing, it will be appreciated that the helical fastener in applicator of the present disclosure functions to securely attach a fastener with high retentive surface area to tissue from one direction through the utilization of an applicator having a simple design. It is also to be appreciated that the present disclosure may be utilized in a number of applications including ligating tissue, hernia mesh repair, bladder neck suspension, and in conjunction with implant drug delivery systems or procedures involving positioning of surgical or implantable devices in patient.
While several particular forms of the disclosure have been illustrated and described, it will also be apparent that various modifications can be made without departing from the spirit and scope of the disclosure.
Thus, it should be understood that various changes in form, detail and application of the present disclosure may be made without departing from the spirit and scope of this disclosure.
The present application claims the benefit of and priority to U.S. Provisional Application Ser. No. 61/348,356, filed on May 26, 2010, the entire contents of which are incorporated herein by reference.
Number | Date | Country | |
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61348356 | May 2010 | US |