US20080097523A1 - Surgical helical fastener with applicator - Google Patents

Abstract

A helical fastener having a high retentive surface area is provided and has a first end for enhancing penetration into tissue and a second end comprising a coil sectioning a diameter of the fastener for receiving longitudinal and rotational forces. The helical fasteners are attached to body tissue by a fastener applicator having a proximal portion comprising a handle and an actuator and an elongate distal portion for housing a plurality of fasteners. A transferring action of the actuator provides longitudinal and rotational movement of the fasteners out of the distal portion and into body tissue.

Description

BACKGROUND OF THE INVENTION
• This invention relates to surgical fasteners and their associated applicators, and more particularly, surgically fastening material to tissue.
• Fasteners have been used surgically to eliminate the need for suturing, which is both time consuming and inconvenient. In many applications the surgeon can use a stapler apparatus, i.e., a fastener implanting device loaded with surgical fasteners to accomplish in a few seconds what would have taken many minutes to perform by suturing. This reduces blood loss and trauma to the patient.
• Conventional surgical fasteners have been in the form of ordinary metal staples, which are bent by the delivery apparatus to hook together body tissue. Typically, conventional staples comprise a pair of legs joined together at one end by a crown. The crown may be a straight member connecting the legs or may form an apex. Moreover, the legs may extend substantially perpendicular from the crown or at some angle therefrom. Irrespective of the particular configuration, however, conventional staples are designed so that they may be deformed to hold body tissue.
• Accordingly, the stapler applicators have conventionally embodied structure functioning to project the conventional staple into tissue as well as to deform the staple so that it is retained against the tissue. Generally speaking, typical applicators include an anvil cooperating with means to eject the conventional staple from the applicator. In some applications, access to the body tissue from two opposite directions is available and the anvil can operate to deform the legs of the staple after they have passed through the body tissue. In applications where access to the tissue is from only one direction, the anvil may deform the crown of the conventional staple so that its legs will project into the body tissue in a fashion so as to hold the staple against the tissue.
• Since conventional staples require deformation and must cooperate with applicators having an anvil or other means to deform the staples, conventional applicators typically comprise complex structures and can be prohibitively expensive. Conventional applicators must embody structure functioning to not only eject the fasteners but to do so in a manner so that the fastener deforms properly and timely.
• In some applications, conventional applicators must be equipped with structure functioning to move the anvil into and out of position so that when the fastener is ejected from the applicator, the anvil is properly positioned and once fastener deformation is complete, moves out of position, thereby allowing the process to be repeated. Moreover, the anvil must be formed into a proper configuration so that fastener deformation can be repeated accurately. Further, the force between the fastener and the anvil must be controlled so that repeated deformation is accomplished. The objectives of many inventions in this field have been to accomplish these goals by the simple manipulation of a single lever. It is to be appreciated, therefore, that the fastener applicators have become complex and expensive instruments.
• Two part fasteners have also been conventionally utilized, where a barbed staple is used in conjunction with a retaining piece to hold the staple in place. Typically, the two part staple comprises a crown or backspan and two barbed prongs which are engaged and locked into a separate retainer piece. In use, the staple is pressed into the body tissue so that the barbs penetrate the tissue and emerge from the other side where they are then locked into the retainer piece. Retainers prevent the staple from working loose from the tissue. The two piece fasteners cannot be unlocked and are not removable.
• Like other conventional applications, however, the two piece fasteners require the staple delivery apparatus to have access to both sides of the tissue. Thus, as with the other conventional applications, two piece fasteners are limited since they cannot be used where access to tissue is from one direction only.
• In those situations where access to body tissues is limited to one direction, as in grafting procedures, deformable surgical fasteners have been conventionally employed. As mentioned previously, however, the applicators commonly used in these situations embody an anvil cooperating with a fastener to deform it and consequently, tend to be of a complex design.
• Some advancements have been made in this area so that applicators functioning to attach grafts to tissue, for instance, are not required to embody an anvil and may, therefore, have a more simple design. In particular, it has been suggested in the art to employ fasteners with barbs, thereby eliminating the need for deforming the fastener. These fasteners are limited, however, since the path created in the graft and tissue by the barbs as the fastener is pressed into the graft and tissue may allow the fastener to loosen its grip or to entirely back out of engagement. Moreover, due to their sole reliance upon barbs to retain tissue, the barb fasteners are further limited in that they may not have a great enough retentive surface area for securely holding tissue in place.
• To circumvent or overcome the problems and limitations associated with conventional fasteners and applicators, a simple applicator that dispenses a surgical fastener having high surface area for retentive contact with tissue and that can be delivered into body tissue from one direction may be employed. The present invention embodies these characteristics.
SUMMARY OF THE INVENTION
• The invention includes a surgical fastener and an applicator used in delivering the fastener into body tissue. The fastener and applicator of the present invention may be used in a number of medical procedures 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 a patient's body.
• The preferred embodiment of the surgical fastener of the present invention is formed into the configuration of a continuous helical coil. The continuous helical coil is longitudinally collapsible and expandable. At the distal end of the helical fastener is a point for enhancing penetration into tissue. The proximal end of the helical fastener has a T-bar which sections the diameter of the fastener, thereby providing a surface for receiving and transmitting longitudinal and rotational forces so that the fastener may be driven into tissue by a corkscrew action. The pitch and length of the helical fastener may vary upon the application as can its diameter and configuration of the most proximal and distal coils comprising the fastener. Additionally, the material selection and fastener stiffness may be selected with a particular application in mind.
• In another embodiment of the surgical fastener, the fastener comprises a double continuous helical coil that is also longitudinally collapsible and expandable and may embody various configurations depending upon the application. Moreover, the distal end of the double helical fastener comprises two points for enhancing penetration into tissue and its proximal end comprises a connector bar which connects the two helixes as well as sections the diameter of the double helical fastener. In yet another embodiment, the surgical fastener further comprises a pivot post extending through the center of the fastener and operating to provide the fastener with a stable pivot. In any of the embodiments, one or more barbs may be employed near the point to enhance anchoring characteristics.
• A preferred embodiment of the fastener applicator of the present invention includes a proximal portion and a distal portion. The proximal portion is preferably fabricated to be a “reusable” component and the distal portion a “disposable” component. Alternatively, both the distal and proximal portion can be made disposable. The distal portion is elongate and embodies an outer tube housing an inner rotator, a lock clip/indicator and a load spring. The proximal portion includes a handle. In the preferred embodiment of the distal portion, a thread form comprising an interlock spring is provided within the outer tube. The rotator includes a structure running longitudinally along its length that functions to receive the T-bar or connector bar of the fastener and in this way, the rotator may hold a plurality of fasteners. The load spring applies a force against the lock clip/indicator operating to bias the plurality of springs distally within the outer tube and towards the nose piece. The thread form functions to engage the coils of the helical fasteners and when rotating the rotator, a fastener is driven from the distal end of the applicator. In other embodiments of the applicator, the distal end has various other structures functioning to engage the coils of the fastener and to drive them from the distal end of the applicator. In one other embodiment, the distal end comprises a nose piece protrusion for engaging the fastener.
• In order to cause the rotator to rotate, the proximal portion of the applicator has a handle and an actuator cooperating with the rotator. In a preferred embodiment, the proximal portion of the applicator embodies a lever pivotally attached about a midpoint to the handle. A first end of the lever is configured to be gripped by hand and a second end is adapted to engage a nut driver. The nut driver travels along a helical lead screw which is connected to the rotator. When the lever is squeezed by hand the nut driver travels along the lead screw causing it to rotate, and through the connection of the lead screw to the rotator, the action of the lead screw causes the rotator to rotate.
• Further, the lever comprises a midsection extension. Pivotally attached to the midsection extension of the lever is a spring loaded pawl adapted to releasably engage gear teeth formed in the interior of the handle. The spring loaded pawl prohibits the lever from backstroking until it has been completely depressed. Upon complete depression of the lever, the pawl clears the gear teeth and the spring, biasing the pawl, rotates the pawl away from the teeth, thereby allowing the lever to return to its undepressed condition.
• In another embodiment of the proximal portion of the applicator, the lever is pivotally attached at a first end to the handle, the second end being adapted to engage the nut driver. Further, rather than embodying a spring loaded pawl, this alternate embodiment of the proximal portion includes a clutch assembly or releasable connection between the lead screw and rotator and cooperating means to prohibit the lever from backstroking until it has been completely depressed.
• Other features and advantages of the present invention will become apparent from the following detailed description, taken in conjunction with the accompanying drawings, which illustrate, by way of example, the principals of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 depicts a perspective view of a fastener of the present invention, illustrating a side view of a helical fastener.
• FIG. 1A depicts another perspective view of the fastener of the present invention, illustrating an end view of the helical fastener.
• FIG. 1B depicts a schematic view of a fastener of the present invention, illustrating a substantially collapsed helical fastener with a relatively small gap that has been partially inserted into tissue.
• FIG. 1C depicts a schematic view of a fastener of the present invention, illustrating the helical fastener depicted inFIG. 1B completely inserted into tissue.
• FIG. 1D depicts a schematic view of a fastener of the present invention, illustrating a substantially collapsed helical fastener with a relatively large gap that has been partially inserted into the tissue.
• FIG. 1E depicts a schematic view of a fastener of the present invention, illustrating the helical fastener depicted inFIG. 1D completely inserted into tissue.
• FIG. 1F depicts a perspective view of another embodiment of the present invention, illustrating an end view of the helical fastener.
• FIG. 2 depicts a perspective view of another embodiment of the present invention, illustrating a double helical fastener.
• FIG. 2A is a front view of the double helical fastener ofFIG. 2.
• FIG. 2B is side view of the double helical fastener ofFIG. 2.
• FIG. 2C is a top view of the double helical fastener ofFIG. 2.
• FIG. 3 is a perspective view of yet another embodiment of the present invention, illustrating another design of a double helical fastener.
• FIG. 3A is a front view of the double helical fastener ofFIG. 3.
• FIG. 3B is a side view of the double helical fastener ofFIG. 3.
• FIG. 3C is a top view of the double helical fastener ofFIG. 3.
• FIG. 4 is a perspective view of the present invention, illustrating a helical fastener with a central post.
• FIG. 5 depicts a schematic cross-sectional view of an applicator of the present invention, illustrating a side view of the applicator.
• FIG. 6 is a schematic cross-sectional side view of a terminal end of the applicator.
• FIG. 6A is a schematic cross-sectional end view of a terminal end of the applicator.
• FIG. 7 is a schematic cross-sectional view of the terminal end of the applicator, illustrating the preferred embodiment of the terminal end.
• FIG. 7A is a schematic cross-sectional end view of the preferred embodiment of the terminal end of the application shown inFIG. 7.
• FIG. 8 is a schematic cross-sectional view of the terminal end of the applicator, illustrating another embodiment of the terminal end.
• FIG. 8A is a schematic cross-sectional end view of the embodiment of the terminal end of the applicator shown inFIG. 8.
• FIG. 9 is a schematic cross-sectional view of the terminal end of the applicator, illustrating yet another embodiment of the terminal end.
• FIG. 9A is a schematic cross-sectional end view of the embodiment of the terminal end of the applicator shown inFIG. 9.
• FIG. 10 is a schematic cross-sectional view of the terminal end of the applicator, illustrating still yet another embodiment of the terminal end.
• FIG. 10A is a schematic cross-sectional end view of the embodiment of the terminal end of the applicator shown inFIG. 10.
• FIG. 11 is a schematic cross-sectional view of the terminal end of the applicator, illustrating another embodiment of the terminal end.
• FIG. 11A is a schematic cross-sectional end view of the embodiment of the terminal end of the applicator shown inFIG. 11.
• FIG. 12 is a schematic cross-sectional view of the terminal end of the applicator, illustrating a further embodiment of the terminal end.
• FIG. 12A is a schematic cross-sectional end view of the embodiment of the terminal end of the applicator shown inFIG. 12.
• FIG. 13 is a schematic cross-sectional view of the terminal end of the applicator, illustrating a still further embodiment of the terminal end.
• FIG. 14 is a schematic cross-sectional view of the terminal end of the applicator, illustrating still yet another embodiment of the terminal end.
• FIG. 15. is a schematic cross-sectional view of another applicator of the present invention, illustrating a side view of the applicator.
• FIG. 16 is a schematic partial cross-sectional view of a releasable connection between the lead screw and rotator.
• FIG. 16A is schematic representation of a distal end of the lead screw, illustrating an end view of the lead screw.
• FIG. 16B is a schematic representation of the distal end of the lead screw, illustrating a side view of the lead screw depicted inFIG. 16.
• FIG. 16C is a schematic representation of the proximal end of the rotator, illustrating a side view of the rotator.
• FIG. 16D is a schematic representation of the proximal end of the rotator, illustrating an end view of the rotator depicted inFIG. 16B.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
• As is shown in the drawings, which are included for purposes of illustration and not by way of limitation, the invention is embodied in a continuous helical fastener and an applicator therefor. 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. Some conventional fasteners require deformation to hold tissue and are consequently limited since they require complex applicators to attach them into tissue. Other conventional fasteners lack high retentive surface area for securely holding tissue. Still other fastener/applicator systems require access to tissue from two directions in order to accomplish attaching a fastener to tissue. Thus, the helical fastener and applicator of the present invention provides a superior means to attach fasteners to tissue.
• One embodiment of the present invention (FIGS. 1, 1A and5) is embodied in ahelical fastener10 which is attached to tissue by employing anovel applicator12 which rotates thefastener10 into tissue. The dimensions and physical characteristics of thehelical fastener10 are selected to insure a secure attachment of thefastener10 to tissue. Similarly, the dimensions and physical characteristics of theapplicator12 utilized to dispense thefasteners10 into tissue are dependent upon the application.
• In a preferred embodiment, thefastener10 is formed into the configuration of a continuous helix and may have adepth16, adiameter18 and apitch20 determined by the application. The continuous helix may be longitudinally collapsible and expandable. The cross-sectional profile of the continuous helix is substantially circular in the preferred embodiment but can be square, rectangular or triangular. In a particular application such as mesh anchoring for hernia repair, the pre-formed pitch can be 0.050 inches. However, the pre-formed pitch can vary from 0 to a maximum of approximately 3.0 times the coil diameter. In other embodiments, it is contemplated that thepitch20 vary along the length of thefastener10 so as to optimize the retaining force of thefastener10. Moreover, since the continuous helical coil is preferably longitudinally collapsible and expandable, upon insertion into tissue, thefinal pitch31 may be less than or greater than the pre-formed pitch. If the coil is made of rigid construction, as is also contemplated, pitch would be made substantially fixed. The diameter in the preferred embodiment may be 5 mm; however, designs ranging from 1 mm and up are contemplated. In practice, thedepth16 of thefastener10 must be selected so that the extent of fastener penetration into tissue is sufficient to hold thefastener10 in place.
• Moreover,distal end22 of thefastener10 is to be configured such that agap23 exists between the most distal coil27 (or first coil) of thefastener10 and its adjacent coil. As may be appreciated from the preferred embodiment ofFIGS. 1B through 1E, as thefastener10 is pressed againsttissue25, all of the coils substantially collapse except the mostdistal coil27, leaving thegap23 to determine the path thefastener10 takes as it is rotated into thetissue25 and more importantly, the extent ofpenetration29 into thetissue25 andfinal pitch31 of thefastener10 in tissue. AlthoughFIG. 1B shows substantially all of the coils being collapsed, it is to be appreciated that, depending upon the applicator utilized to implant thefastener10, fewer coils than all of the coils may be collapsed at any one time. It remains, however, that since thefastener10 is longitudinally collapsible and expandable, it is thegap23 that generally determinesfinal pitch31. Accordingly, the magnitude of thegap23 can be varied, depending upon the application, to achieve the desiredfinal pitch31 andpenetration29 in tissue. Thus, the greater thegap23, upon insertion of thefastener10 in tissue, the greater thepenetration29 andfinal pitch31 of thefastener10 in tissue.
• In the preferred embodiment, thedistal end22 of thehelical fastener10 terminates with apoint24. Thepoint24 may be sharp or blunt depending upon the tissue to which thefastener10 will be affixed. Additionally, one or more barbs or a sharp point projecting in reverse direction to point24 (not shown) can be added tofastener10near point24 to enhance anchoring characteristics of the fastener. Aproximal end26 of thehelical fastener10 may comprise structure functioning to receive and transmit applied longitudinal forces. In the preferred embodiment, the most proximal coil is formed into a T-bar33 that perpendicularly sections thediameter18 of thefastener10. In alternate embodiments, it is also contemplated that the most proximal coil section thediameter18 non-perpendicularly or be formed into a spiral35 existing in a single plane (SeeFIG. 1F).
• Concerning the material of thehelical fastener10, it is contemplated in the preferred embodiment that the fastener be made from semi-stiff implantable wire, such as titanium, wound into a helical shape. In alternate embodiments, thehelical fastener10 may comprise plastic or absorbable materials. Examples of materials that can be used in constructing thehelical fastener10 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.
• In another embodiment of the surgical fastener, thefastener110 is formed into the configuration of a double helix (SeeFIGS. 2-2C). By embodying a double helix, thefastener110 has increased retentive strength as well as means to balance thefastener110 as it is pressed into tissue. As with thehelical fastener10, the configuration of the doublehelical fastener110, i.e., the pre-formed pitch and diameter, may be varied for a particular application and a barb may be employed to enhance anchoring in tissue. Moreover, the materials contemplated are the same as those for the helical fasteners. Further, the doublehelical fastener110 is also longitudinally collapsible and expandable and its final pitch is dependent upon thegap112 existing between the mostdistal coils114,115 of thefastener110 and their adjacent coils.
• Regarding the proximal118 and distal120 ends of the doublehelical fastener110, they comprise structure to drive the fastener into tissue as well as tissue piercing structures. Theproximal end118 has aconnector bar122 sectioning the diameter of the fastener that connects one helical coil to another and functions to receive and transmit longitudinal forces. Thedistal end120 terminates with twopoints124,125 for piercing and facilitating the implantation of thefastener110 into tissue.
• As may be appreciated by comparingFIGS. 2-2D withFIGS. 3-3D, it is contemplated that the doublehelical fastener110 have a full turn design (FIG. 22D) as well as a half turn design (FIGS. 3-3D). It is to be understood, however, that the designs having more than one turn and having other increments of turns are contemplated. It is the applicator that will determine the required number of turns for aspecific fastener110.
• In yet another embodiment of the surgical fastener, as shown inFIG. 4, the doublehelical fastener110 is provided with apivot post130 having a pointedterminal end132. Thepivot post130 of this embodiment operates to provide thefastener110 with a stabilizing element so that, as thefastener110 is being turned, the helical coils cooperatively enter the tissue.
• The applicator12 (FIG. 5) comprises aproximal portion28 having ahandle30 and anactuator32 and a cooperating elongated distal portion orcannula34 housing a plurality of fasteners. In general, through the manipulation of theactuator32, the fasteners are ejected, one by one, out of adistal portion34 and into body tissue. Theapplicator12, hereinafter described in more detail, is equally proficient in driving each of the embodiments of fasteners set forth above into tissue.
• In more detail (SeeFIGS. 6 and 6A), thedistal portion34 comprises anouter tube36 housing arotator38, a lock/clip indicator40 and aload spring42. Extending longitudinally along therotator38 is agroove44 which operates to receive the most proximal coil sectioning the fastener. AlthoughFIG. 6 shows only a single fastener (having a single helical design) retained by therotator38, it is to be appreciated that therotator38 may receive a plurality of fasteners (having a single or double helical design), wherein each fastener has its last coil positioned within therotator groove44. Moreover, although not depicted inFIG. 3, it is also contemplated that rather than embodying a groove, therotator38 has a cross-sectional profile approximately a “D”, wherein the flat portion operates to engage the coil sectioning the fasteners. Irrespective of the configuration of the rotator, however, the rotator is to embody structure functioning to engage a plurality of fasteners and to facilitate turning them into tissue.
• It is also to be appreciated thatload spring42 applies a force through thelock clip indicator40 to bias the plurality of fasteners distally. The lock clip/indicator40 may comprise a simple washer sized and shaped to engage the fasteners androtator38 as well as to receive forces from theload spring42. Additionally, lock/clip indicator40 serves as a jam stop to prevent further actuation byrotator38 upon discharge of all fasteners by mating with, or abutting against, structure comprising theterminal end50 and preventing further rotation. Lock/indicator40 can be made of a color (or shape) to serve as an empty indicator notifying the user that no more fasteners are available. Other embodiments of theindicator40 may be utilized as long as they function to transmit forces to bias the fasteners distally. Theload spring42 is to be retained within theouter tube36 and to have physical characteristics such that sufficient forces may be applied through afront end43 to a last remaining fastener contained within theapplicator12. A back end (not shown) of theload spring42 may be placed against any stationery structure within theouter tube36, thereby providing a foundation against which thespring42 may be compressed. In a preferred embodiment, theload spring42 extends substantially the length of thedistal portion34.
• In the preferred embodiment (FIGS. 7 and 7A), theouter tube36 is configured with athread form201 comprising aninterlock spring203 fixedly retained within theouter tube36 and extending substantially the length thereof. Theinterlock spring203 may be fixedly retained within theouter tube36 by ensuring a tight interference between the parts or the interlock spring may be spot welded or equivalently bonded within the outer tube. Thethread form201 operates to guide the fasteners through thedistal portion34 and to eject them from theapplicator12.
• In another embodiment of the applicator12 (FIGS. 8 and 8A), attached at aterminal end46 of thedistal portion34 may be anose piece48. Thenose piece48 may further comprise aprotrusion50 extending perpendicularly and towards a longitudinal axis52 of thedistal portion34. Thisnose piece protrusion50 also functions to engage the surgical fasteners and to force them from theterminal end46 of thedistal portion34 as well as engaging lock/clip indicator40 as described above.
• In other embodiments of theapplicator12, the distal portion embodies other structure or thread forms functioning to engage the surgical fasteners and guide them out of the applicator and into tissue (SeeFIGS. 9-14). InFIGS. 9 and 9A, theouter tube36 is rolled at itsterminal end46 and a 180 DEG portion of the rolled terminal end is cut away. The remaining rolled portion engages the fastener while the portion cut away provides an exit for the fasteners. The embodiment depicted inFIGS. 10 and 10A is similar to that ofFIGS. 9 and 9A, the difference being that instead of removing a portion of the rolledterminal end46, it is stamped or deformed to thereby provide an exit.FIGS. 11 and 11A show yet another embodiment, wherein two longitudinally spaced apart stabilizingpoints301,302 are formed 180 DEG from each other within the outer tube. These stabilizing points also operate to engage the fastener and guide it into tissue. Turning toFIGS. 12, 12A,13 and14, they each comprise aterminal end46 formed with threads which operate to engage and eject a fastener. InFIGS. 12 and 12A are depicted threads machined or formed solely within the inside of the outer tube.FIG. 13 shows an internally threaded sleeve attached to the outside of theterminal end46 of theouter tube36.FIG. 14 illustrates anapplicator12 provided with aterminal end46 deformed so as to have internal and external threaded structures. Irrespective of the design chosen for the terminal end of the applicator, however, each of the designs are effective with a relatively small overall outer diameter, i.e., on the order of 5 mm.
• In order to eject surgical fasteners from thedistal portion34, the actuator32 functions to turn therotator38. As the rotator turns, thedistal end22 of a fastener is threaded out of theterminal end46 of the applicator12 (seeFIG. 5).
• In the preferred embodiment of theproximal portion28 of the applicator12 (SeeFIG. 5), alever54 is pivotally connected about amidpoint56 to thehandle30. Afirst end58 of thelever54 is to be configured for gripping by hand. Asecond end60 of the lever is to be adapted to pivotally engage anut driver62.
• Thenut driver62 of theapplicator12 travels upon a highhelix lead screw64 which is rotatably mounted within theproximal portion28. In the preferred embodiment, a longitudinal axis of the highhelix lead screw64 is coaxial with the longitudinal axis52 extending through thedistal portion34 of theapplicator12. Upon manipulation of thelever54, thenut driver62 travels along thelead screw64 causing it to rotate through a connection of thelead screw64 to therotator38, the action of the lead screw causes the rotator to rotate. Thelead screw64 may be connected to therotator38 by any conventional means. For instance, thelead screw64 can have an internal bore receiving and engaging an end of therotator38. Further, the length of travel of thenut driver62 along thelead screw64 is chosen such that it causes the rotator to rotate a predetermined number of times so that a singlehelical fastener10 is ejected from theapplicator12.
• Additionally, in the preferred embodiment, the lever further comprises amidsection extension66. Pivotally attached to themidsection extension66 of thelever54 is contemplated to be a spring loadedpawl68 adapted to releasably engage gear teeth70 formed in the interior of thehandle30. Spring loadedpawl68 is configured to prohibit thelever54 from backstroking until it has been completely depressed. Upon complete depression of thelever54, thepawl68 clears the gear teeth70 and the spring biasing thepawl68 rotates thepawl68 away from the teeth70, thereby allowing thelever54 to return to its undepressed condition.
• In operation, upon complete depression of thelever54, thenut driver62 travels a pre-determined distance along thelead screw64, causing therotator38 to rotate a pre-determined number of revolutions corresponding to a number of turns of a particularhelical fastener10. As therotator38 rotates, the fasteners retained by the rotator also rotate and the coils of the most distal fastener are threaded out of theterminal end46 of theapplicator12 and into tissue. Moreover, where thelever54 is only partially depressed, the spring loadedpawl68 operates to hold thelever54 stationery and will continue to function to hold thelever54 stationery until thelever54 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 theapplicator12 and pressed into body tissue at a time.
• In the preferred embodiment, theproximal portion28 is fabricated to have a reusable handle that can be re-sterilized, and the distal portion is made disposable. Thus, upon discharge of all thefasteners10 fromdistal portion34, the distal portion would be discarded and replaced. The handle could be reused up to a limited number of procedures.
• In another embodiment of theproximal portion328, of the applicator312 (FIG. 15), alever354 is pivotally connected at afirst end355 to thehandle330 and biased to its undepressed position by aspring357. Themid-section358 of the lower354 is configured for gripping by hand. Asecond end360 of the lever is to be adapted to pivotally engage anut drive362.
• Thenut driver362 of theapplicator312 travels along a high helixlead screw364 which is rotatably mounted within theproximal portion328. Upon manipulation of thelever354, the nut driver travels along thelead screw364 causing it to rotate and, through a clutch assembly or a releasable connection of thelead screw364 to therotator38, the action of the lead screw causes the rotator to rotate.
• Further, thelever354, has amid-section extension366 that cooperates with a spring biasedlatch pawl mechanism368 fixed to the handle adapted to releasably engageteeth370 formed on themid-section extension366. The spring biased latch pawl is configured to prohibit thelever354 from backstroking until it has been completely depressed. Upon complete depression of thelever354, thelatch pawl368 clears themid-section teeth370 and the springbiased latch pawl368 rotates away from the teeth, thereby allowing thelever354 to return to its undepressed condition.
• As stated, there is a releasable connection between thelead screw364 and the rotator. The releasable connection provides the applicator with means to disengage the distal portion of the applicator from the proximal portion. In this way, the proximal portion can be re-used with various different designs of the proximal portion. Further, while thelever354 is being depressed, the clutch assembly or releasable connection functions to transfer the rotation of thelead screw364 to therotator38, thereby causing the rotator to rotate. Additionally, upon complete depression of the lever, the clutch assembly operates to allow relative motion of thelead screw364 and the rotator.
• One such releasable connection contemplated is a conventional ratchet mechanism. As shown inFIGS. 16-16D, thedistal end370 of thelead screw364 has a connectingsurface372 equipped withleaf springs374,376 each having an engagingface377 and aninternal bore378 existing coaxially with a longitudinal axis of the lead screw. Theproximal end380 of therotator38 has a cooperating connectingsurface382 havingridges384 for releasable engagement with theleaf springs374,376 and anextension386 adapted to fit within the internal bore of the lead screw connecting surface. As may be appreciated from the FIGS., as the lead screw turns so that theridges384 contact the engaging faces377 of theleaf springs374,376, the rotation of thelead screw364 will cause therotator38 to likewise rotate. Where the lead screw is turned in the opposite direction, theridges384 will not engage the engaging face of the leaf springs and the motion of thelead screw384 will not be transferred to therotator38.
• In this embodiment, upon complete depression of thelever354, thenut driver362 travels a pre-determined distance along thelead screw364, causing therotator38 to rotate a pre-determined number of revolutions. As therotator38 rotates, the fasteners retained by the rotator also rotate and the coils of the most distal fasteners are threaded out of the applicator and into the tissue. At this point, thelatch pawl mechanism368 disengages from theteeth370 and thelever354 is returned to its undepressed position byspring357. As with the previous embodiment of theproximal portion28, the proximal portion of this embodiment functions to allow only a single fastener to be completely ejected from the applicator and be pressed into body tissue at a time.
• In other embodiments, means to cause the rotator to rotate may comprise a single knob connected to a rotator which can be turned by hand. Additionally, the revolving means may include a rack and gear structure or a set of beveled gears. Further, instead of comprising a groove, the rotator may be internally threaded, wherein the threaded portions function to house as well as advance thehelical fasteners10. Irrespective of the means or structure employed, however, it is contemplated that the number of revolutions of the rotator be set to a pre-determined parameter so that the delivery of helical fasteners to tissue may be controlled.
• From the foregoing, it will be appreciated that the helical fastener in applicator of the present invention 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 invention 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 invention 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 invention.
• Thus, it should be understood that various changes in form, detail and application of the present invention may be made without departing from the spirit and scope of this invention.

Claims (17)

1. (canceled)

2. A surgical fastener comprising:

a continuous double helical coil having a distal end and a proximal end, the distal end terminating with dual points each for piercing tissue;

dual first helical coil sections adjacent the distal end each being associated with one of the dual points and each defining a gap therebetween; and

a connecting bar at the proximal end for engagement with an applicator for inserting the double helical coil into tissue to position.

3. The fastener ofclaim 2, wherein the gap is adapted to determine depth of penetration and pitch of the fastener in tissue and retentive strength of the fastener to tissue.

4. The fastener ofclaim 2, wherein the continuous double helical coil has uniform pitch between coils.

5. The fastener ofclaim 2, wherein the continuous double helical coil has a pitch between coils that can be varied by the applicator.

6. The fastener ofclaim 2, wherein the continuous double helical coil has a pitch that can be increased as the fastener is inserted into tissue.

7. The fastener ofclaim 2, wherein the continuous double helical coil is formed from a resorbable material.

8. The fastener ofclaim 2, wherein the continuous double helical coil is formed from a biocompatible metal.

9. The fastener ofclaim 2, wherein the continuous double helical coil is longitudinally collapsible and expandable.

10. The fastener ofclaim 2, further comprising a pivot post extending from the connecting bar and toward the distal end, the pivot post having a pointed terminal end.

11. A surgical fastener comprising:

a plurality of helical spikes engageable with body tissue, each of the plurality of helical spikes having a helical central axis that forms a helix around the central axis of the surgical fastener, wherein each of the plurality of helical spikes further includes a circular cross-sectional configuration as viewed in a plane extending perpendicular to the helical central axis of each of the helical spikes and having a distal end portion with a tip that penetrates the body tissue as the surgical fastener is rotated relative to the body tissue; and

a connecting member located at a proximal end of the surgical fastener, the connecting member extending transverse to the central axis of the surgical fastener and attached to each of the helical spikes in the plurality of helical spikes, wherein the connecting member is engageable with the body tissue.

12. An applicator for applying fasteners comprising:

an elongate tubular member;

a rotator disposed in the tubular member;

a housing coupled to a proximal end of the tubular member;

a trigger pivotably disposed in the housing;

at least one fastener disposed in the tubular member, the at least one fastener having a helical configuration;

an actuation mechanism disposed in the housing, the actuation mechanism responsive to manipulation of the trigger for rotating the rotator relative to the tubular member and advancing the at least one fastener towards a distal end of the tubular member.

13. The applicator ofclaim 12, wherein at least a portion of the tubular member includes threads for engaging the at least one fastener.

14. The applicator ofclaim 12, further including a load spring for biasing the at least one fastener towards the distal end of the tubular member.

15. The applicator ofclaim 12, wherein the rotator extends substantially the length of the tubular member.

16. The applicator ofclaim 12, further including a lead screw rotatably disposed in the housing and responsive to manipulation of the trigger.

17. The applicator ofclaim 16, wherein the rotator is rotatably coupled to the lead screw.

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