The present invention generally relates to securing implants to tissue, and more specifically relates to systems, devices and methods that utilize surgical fasteners for securing implants to tissue.
Hernia is a condition where a small loop of bowel or intestine protrudes through a weak place or defect within the abdominal muscle wall or groin of a patient. This condition commonly occurs in humans, particularly males. Hernias of this type may result from a congenital defect whereby the patient is born with this problem, or may be caused by straining or lifting heavy objects. Heavy lifting may be known to create a large amount of stress upon the abdominal wall and can cause a rupture or tearing at a weak point of the abdominal muscle to create the defect or opening. In any case, the patient may be left with an unsightly bulge of intestinal tissue protruding through the defect, which may result in pain, reduced lifting abilities, and in some cases, impaction of the bowel, or possibly other complications if the flow of blood is cut off to the protruding tissue.
A common solution to the above-described problem may be surgery. During a surgical procedure, the defect is accessed and carefully examined, either through an open incision or endoscopically through an access port such as a trocar. In either case, careful examination is required due to the network of vessels and nerves which exist in the area of a typical defect, which requires a surgeon to conduct a hernia repair with great skill and caution. Within this area can be found vascular structures such as gastric vessels, the external iliac vessels, and the inferior epigastric vessels, as well as reproductive vessels such as the vas deferens extending through the inguinal floor.
Once the surgeon is familiar with the anatomy of a patient, the surgeon carefully places the viscera back into the patient's abdomen through the defect. Repairing the defect can involve closure of the defect with sutures or fasteners but generally involves placing a surgical prosthetic such as a mesh patch over the open defect, and attaching the mesh patch to the abdominal wall or inguinal floor using a conventional suture or surgical fasteners. The mesh patch acts as a barrier and prevents expulsion of bowel through the defect. Suturing of the mesh patch to the inguinal floor can be well suited to open procedures but can be much more difficult and time consuming with endoscopic procedures. With the adoption of endoscopic surgery, endoscopic surgical instruments that apply surgical fasteners can be used. However, the tissue of the inguinal floor may offer special challenges to the surgeon when a needle or fastener is used to penetrate structures such as Cooper's ligament.
At present, there are a variety of surgical instruments and fasteners available for the surgeon to use in an endoscopic or open procedure to attach the mesh patch to the inguinal floor. One of the earliest types of endoscopic surgical instruments used is a surgical stapler. A plurality or stack of these unformed staples may be generally contained within a stapling cartridge in a serial fashion, and may be sequentially advanced or fed within the instrument by a spring mechanism. A secondary valving or feeding mechanism may be employed to separate the distal most staple from the stack, to hold the remainder of the spring loaded stack, and may be used to feed the distal most staples into the staple forming mechanism. Feeding mechanisms of this type are found in U.S. Pat. No. 5,470,010 to Rothfuss et al., and in U.S. Pat. No. 5,582,616, also to Rothfuss et al.
Another hernia mesh attachment instrument uses a helical wire fastener that resembles a small section of spring. Multiple helical wire fasteners may be stored serially within the 5 mm shaft, and may be corkscrewed or rotated into tissue. A load spring may be used to bias or feed the plurality of helical fasteners distally within the shaft. A protrusion extends into the shaft to possibly prevent the ejection of the stack of fasteners by the load spring and may permit passage of a rotating fastener. Instruments and fasteners of these types are found in U.S. Pat. No. 5,582,616 to Bolduc et al., U.S. Pat. No. 5,810,882 to Bolduc et al., and in U.S. Pat. No. 5,830,221 to Stein et al.
Whereas the above surgical instruments may be used for hernia fastening applications, they use a spring mechanism to feed a plurality of fasteners through the surgical instrument. Spring mechanisms typically use a long soft coil spring to push a stack of fasteners through a guide or track within the shaft of the surgical instrument. These types of feeding mechanisms may be generally simple and reliable, but may require an additional secondary valving mechanism or protrusion to separate and feed one fastener from the stack.
Other surgical fasteners may be used for hernia mesh attachment but utilize either a reloadable single shot instrument or a rotary magazine that holds a small number of fasteners. These types of surgical fastening instruments can be found in U.S. Pat. No. 5,203,864 and U.S. Pat. No. 5,290,297, both to Edward Phillips. These instruments have not gained acceptance by the surgical community, possibly due to their single shot capabilities and the large size of the rotary magazine, which can restrict such an instrument to an open procedure.
Whereas all the above surgical instruments may be used for hernia fastening applications, they either use a spring mechanism to feed the plurality of fasteners through the surgical instrument, or a rotary magazine in lieu of a feeding mechanism. Other types of surgical fasteners may be available, such as surgical clips, and they can utilize feeding mechanisms that do not require the use of a spring to feed the clips distally. A reciprocating feeding mechanism is described in U.S. Pat. Nos. 5,601,573; 5,833,700; and U.S. Pat. No. 5,921,997 to Fogelberg et al. The Fogelberg et al. references teach a clip applier with a feeding mechanism that utilizes a reciprocating feed bar to feed a serial stack of clips. A feeder shoe may operably engage with and move with the distally moving feed bar and may slidingly engage with the proximally moving feed bar. Thus, the feeder shoe may index or push the stack of clips distally with the distally moving feed bar and remains stationary relative to the proximally moving feed bar. A valving mechanism may be also required to separate the distal-most clip from the stack and to hold the stack stationary as the distal most clip may be applied onto a vessel. Whereas the Fogelberg et al. references teach a reciprocating feeding mechanism with a single reciprocating member, they do not teach the use of the clip applier in the attachment of hernia mesh, nor do they teach the individual driving or feeding of each clip by a moving member.
Another fastener feeding mechanism that uses reciprocation is that disclosed in U.S. Pat. No. 4,325,376 to Klieman et al. A clip applier that stores a plurality of clips in a serial fashion within a clip magazine is disclosed. The clips are in a stack wherein the proximal most clip may be pushed or fed distally by a pawl that may be ratcheted or indexed distally by a reciprocating member or ratchet blade with each actuation of the instrument. As the pawl indexes distally, it can push the stack of clips distally. A secondary valving mechanism may be also described. Thus, the feeding mechanism of Klieman et al. teaches the use a single reciprocating member and pawl to push or feed the stack of clips distally, and may require a secondary valving mechanism to feed the distal most clip.
U.S. Pat. No. 3,740,994 to DeCarlo Jr. describes a novel reciprocating feeding mechanism that may index a plurality of staples or clips, and may ready them for discharge by reciprocating one of a pair of opposing leaf spring assemblies. The staples reside serially within a guide rail with a fixed leaf spring assembly extending into the plane of the guide rail. A reciprocating leaf spring assembly may opposedly extend inwardly towards the fixed leaf spring assembly. As the reciprocating leaf spring assembly moves distally, each of individual leaf springs of the assembly may engage a staple and move it distally. The distally moving staples deflect the local individual leaf springs of the fixed leaf spring assembly, and the deflected leaf springs may return to the un-deflected position after passage of the staple. As the moving leaf spring assembly moves proximally, the leaf springs of the fixed leaf spring assembly hold the staples stationary and prevent proximal movement thereof. A secondary guide rail and valving mechanism may be provided to separate a single staple from the stack for forming and can hold the stack of staples stationary as the single clip is formed.
Additionally, similar feeding mechanisms are disclosed in U.S. Pat. No. 4,478,220 to DiGiovanni et al. and U.S. Pat. No. 4,471,780 to Menges et al. Both of these related patents teach a reciprocating feeding mechanism that uses one fixed member and one reciprocating member to feed or index a plurality of clips distally. Angled flexible fingers may be hingedly attached to the reciprocating member and operatively engage the clips when moving distally, and slidingly engage with the clips when moving proximally. The angled flexible fingers within the fixed member deflect out of the way when the clips move distally and spring up to stop proximal movement of the clip after the clip has passed. A secondary valving mechanism is also disclosed.
Commonly assigned U.S. Patent Application Publication No. 2002/0068947, the disclosure of which is hereby incorporated by reference herein, teaches a device for delivering a plurality of individual surgical fasteners. In one embodiment, the delivery device includes a drive mechanism having distal and proximal ends. The drive mechanism has a moving member and a fixed opposing member, whereby the moving member is moveable proximally and distally with respect to the delivery device. The moving member has a sharpened distal end for piercing tissue. The device includes at least one surgical fastener located between the first and the second members. Each of the at least one surgical fasteners has a proximal end and a distal end. The device also has an actuator having at least two sequential positions. A first position for moving the moving member distally and piercing tissue, and a second position for moving the moving member proximally, thereby deploying the distal end of the fastener.
Tacks for fixing meshes used laparoscopically have generally been made of metal, such as stainless steel, nitinol, or titanium. The metal tacks were necessary to provide for sufficient holding strength, penetration of various prosthetic meshes, and for ease of manufacture. Until recently, there were no absorbable tacks available on the market, and surgeons could only use absorbable sutures in order to provide a fixation means that did not permanently stay in the body. However, using sutures is exceedingly difficult for laparoscopic procedure, and so they are generally not used unless the repair is done in an open fashion. With surgical trends leading to more minimally invasive techniques with minimum foreign body accumulation, an absorbable tack with minimum profile that can be applied laparoscopically is needed.
In spite of the above advances, there remains a need for applicator systems for fixing implants using surgical fasteners whereby the surgical fasteners 1) have a minimum profile, 2) may be applied laparoscopically, and 3) are absorbable. There also remains a need for applicator systems for surgical fasteners that are economical, that use cartridges pre-loaded with surgical fasteners having 1) different sizes, 2) different material compositions, 3) different quantities, and 4) that provide surgical fasteners having curved legs to enable shallower implant fixation. Moreover, there remains a need for applicator systems for surgical fasteners that 1) provide the user with a one-to-one tactile feel when inserting a surgical fastener into tissue, 2) provide the user with manual control over the amount of insertion force, 3) enable the user to push the surgical fastener further into tissue, if desired, and 4) provide the user with a broad range of mechanical fixation capabilities that are similar to those available when using sutures.
In one embodiment, an applicator system for inserting surgical fasteners preferably includes a manually controlled insertion tool having a distal end with an insertion fork that is adapted to slide over the legs of a surgical fastener for loading the surgical fastener onto the insertion fork. The loaded insertion fork is then utilized for inserting the surgical fastener into tissue for securing an implant, such as a mesh implant, to the tissue.
In one embodiment, the applicator system preferably includes one or more cartridges, each of which have a plurality of surgical fasteners pre-loaded therein. In one embodiment, the cartridges have a plurality of elongated slots and a single surgical fastener accessible through each elongated slot. The surgical fasteners are preferably removable from the cartridge for being inserted into tissue for securing an implant, such as a surgical mesh, to the tissue. In one embodiment, in order to remove a surgical fastener from the cartridge, an insertion fork is inserted into one of the elongated slots for loading one of the surgical fasteners onto the insertion fork. After loading the surgical fastener onto the insertion fork, the insertion fork may be removed from the elongated slot and transferred to a surgical site for being manually inserted into tissue by the insertion fork.
In one embodiment, the applicator system disclosed herein incorporates one or more features disclosed in commonly assigned U.S. Patent Appln. Publication Nos. US 2010/0292715, US 2010/0292712, US 2010/0292710, US 2010/0292713, and US 2011/079627, U.S. patent application Ser. No. 13/470,022, filed May 11, 2012, entitled “APPLICATOR INSTRUMENTS FOR DISPENSING SURGICAL FASTENERS DURING OPEN REPAIR PROCEDURES”, U.S. patent application Ser. No. 13/470,065, filed on May 11, 2012, entitled “APPLICATOR INSTRUMENTS HAVING DISTAL END CAPS FOR FACILITATING THE ACCURATE PLACEMENT OF SURGICAL FASTENERS DURING OPEN REPAIR PROCEDURES”, and U.S. patent application Ser. No. 13/791,950, filed Mar. 9, 2013, entitled “SURGICAL FASTENERS HAVING ARTICULATING JOINTS AND DEFLECTABLE TIPS,” the disclosures of which are hereby incorporated by reference herein.
In contrast to mesh fixation systems having gun-like insertion tools that automatically dispense a fastener each time a trigger is pulled, the present application discloses a versatile manual system that enables an insertion fork to be manually engaged for handling only one surgical fastener at a time.
The manual system disclosed herein provides a number of benefits. In one embodiment, the insertion tool provides the user with a one-to-one tactile feel when manually inserting a surgical fastener into tissue.
In one embodiment, because the applicator system is manual and not automatic, the insertion tool enables a user to manually control and adjust the amount of insertion force used when inserting a surgical fastener into tissue.
In one embodiment, the manual system enables a user to push a surgical fastener further into tissue, if desired.
The present application also preferably provides more versatility over the types of surgical fasteners that may be inserted into the tissue. For example, the size, configuration and type of surgical fastener can be easily changed during a surgical procedure. This is an advantage over automatic applicator guns that only dispense one type of surgical fastener.
In one embodiment, the insertion tool may include a stored energy element that provides a level of insertion force when using the insertion fork to insert a surgical fastener in tissue. In one embodiment, the insertion tool uses only manual energy provided by the user. In one embodiment, the insertion tool combines the manual energy provided by the user with the energy from the stored energy element to provide insertion force for inserting a surgical fastener in tissue.
In one embodiment, the insertion tool preferably includes a safety release element that prevents the use of excessive insertion force when inserting a surgical fastener into tissue. In one embodiment, the safety release element may be coupled with the elongated shaft 46 or the insertion fork 52 to prevent the use of excessive force during insertion of a surgical fastener. In one embodiment, the shaft 46 or the insertion fork 50 will collapse upon reaching a pre-set or pre-determined level of force. In one embodiment, the safety release element may include a spring that is tripped when a pre-set level of force is reached to prevent over insertion of a surgical fastener, or the use of excessive insertion force.
In one embodiment, a single cartridge may be loaded with surgical fasteners having different sizes and/or properties. In one embodiment, multiple cartridges may be used whereby each cartridge is loaded with surgical fastener having a particular size and/or property.
In one embodiment, one or more cartridges may be loaded with surgical fasteners made of different materials, such as a first cartridge loaded with surgical fasteners that are absorbable, a second cartridge loaded with surgical fasteners that are non-absorbable, a third cartridge loaded with surgical fasteners having straight legs, and a fourth cartridge loaded with surgical fasteners having curved legs.
In one embodiment, surgical fasteners having different sizes, shapes, configurations, flexibility, materials, and other properties may be contained within a single cartridge. In one embodiment, a plurality of cartridges may be provided, whereby each cartridge contains a plurality of surgical fasteners having the same properties, e.g., size, shape, configuration, flexibility, materials, etc. In one embodiment, the cartridges and/or the surgical fasteners may be color coded or have indicia provided thereon to indicate the properties of the surgical fasteners contained within the cartridges.
In one embodiment, the cartridges may be held by hand. In one embodiment, the cartridges are secured upon a support base, such as a metal LC-800 base.
In one embodiment, an insertion tool having an insertion fork may be utilized in conjunction with a needle driver having opposing clamping jaws that hold the insertion tool.
In one embodiment, an insertion tool may have a shaft with a distal end that includes an insertion fork. The shaft of the insertion tool may be straight, curved, or angled. In one embodiment, the shaft of the insertion tool is curved to mimic the configuration of a suture needle.
In one embodiment, because the insertion tool is held manually by a user, the insertion tool provides the user with more flexibility that enables mechanical fixation of the surgical fastener in a manner that is closer to that found when using sutures and suture needles.
In one embodiment, the insertion tools disclosed herein may be used for inserting surgical fasteners during open procedures such as open inguinal procedures, open ventral fixation procedures, and laparoscopic procedures.
In one embodiment, the length and geometry of the insertion tools may be modified to accommodate different surgical procedures.
In one embodiment, the surgical fasteners may have first and second legs having distal ends with respective insertion tips. In one embodiment, the legs may be curved for shallower implant fixation procedures.
In one embodiment, an insertion tool having an insertion fork may include a luer type connector connected to a proximal end of the insertion fork.
In one embodiment, the manual applicator system disclosed herein eliminates the need for more expensive, disposable gun-like applicator instruments that are used only once and then disposed.
In contrast to disposable gun-like applicator instruments that have a single type of fastener, the cartridge system disclosed herein provides more flexibility with respect to 1) using different sized surgical fasteners, 2) using surgical fasteners made of different materials, 3) having access to cartridges having different quantities of surgical fasteners, and 4) having different sized straps within a single cartridge.
The present invention provides many of the benefits found in gun-like applicator instruments without the cost of a pre-loaded device. Rather than requiring a complicated device and its components to be revised for each strap configuration, the present invention is able to easily accommodate different surgical fastener configurations and sizes by providing a simple cartridge system.
The manual insertion system disclosed herein provides a number of advantages over gun-like applicator systems that dispense a fastener each time a trigger is pulled. In one embodiment, the manually controlled insertion tool provides a user with a one-to-one tactile feel when inserting a surgical fastener into tissue. In one embodiment, the manually controlled insertion tool enables a user to manually control the amount of insertion force used to insert a surgical fastener into tissue. In one embodiment, the manually controlled system enables the user to push a surgical fastener further into tissue, if desired.
In one embodiment, an applicator system for implant fixation enables surgical fasteners to be inserted into tissue manually. In one embodiment, an applicator system uses a standard needle driver that holds an insertion tool with an insertion fork between the clamping jaws of the needle driver.
In one embodiment, the applicator system includes an insertion tool that is pen-like with either a disposable or a re-usable handles. In one embodiment, single-use insertion forks are attached to an end of the handles.
In one embodiment, the surgical fasteners are held in the cartridge via the geometry of the surgical fastener or by annealing the surgical fastener. In one embodiment, the cartridge includes a flexible element that retains the surgical fasteners in the cartridge until an insertion fork is inserted into the cartridge to compress the flexible element for releasing a single surgical fastener.
In one embodiment, an applicator system includes an insertion tool that has either a straight, curved, or angled insertion fork. In one embodiment, the insertion tool preferably has a curved shaft that mimics the shape of a curved suture needle.
In one embodiment, the length and geometry of the insertion tool may be modified to accommodate different surgical procedures and different body locations.
In one embodiment, an insertion tool preferably includes a protective outer sheath that covers the insertion fork during advancement to a surgical site, and that is retracted relative to the insertion fork to expose the insertion fork and enable the insertion fork to be utilized for inserting a surgical fastener into tissue.
In one embodiment, an applicator system preferably includes a base that holds one or more cartridges atop the base using tongue and groove features found on the base and the cartridges.
In one embodiment, a surgical fastener preferably includes a first leg including a proximal end, a distal end, and a first insertion tip at the distal end of the first leg, a second leg including a proximal end, a distal end, and a second insertion tip at the distal end of the second leg, and a bridge connecting the proximal ends of the first and second legs for forming a closed end of the surgical fastener.
In one embodiment, the first and second legs are curved between the bridge and the first and second insertion tips at the distal ends of the respective first and second legs. In one embodiment, the first leg includes a first rib extending along a length of the first leg, and the second leg includes a second rib extending along a length of the second leg, whereby the first and second ribs have curves that mirror the curvature of the first and second legs.
In one embodiment, each of the first and second legs desirably includes an inner wall, an outer wall facing away from the inner wall, a top surface extending between the inner and outer walls, and a bottom surface extending between the inner and outer walls and facing away from the top surface. In one embodiment, the top surfaces of the respective first and second legs face in the same direction and define concavely curved surfaces. In one embodiment, the bottom surfaces of the respective first and second legs face in the same direction, which is opposite the top surfaces of the first and second legs, and define convexly curved surfaces.
In one embodiment, a surgical fastener for anchoring medical devices to tissue preferably includes a first leg having a proximal end, a distal end, a first rib projecting from an outer wall of the first leg and extending between the proximal and distal ends of the first leg, and a first insertion tip at the distal end of the first leg, and a second leg having a proximal end, a distal end, a second rib projecting from an outer wall of the second leg and extending between the proximal and distal ends of the second leg, and a second insertion tip at the distal end of the second leg. In one embodiment, a bridge connects the proximal ends of the first and second legs for forming a closed end of the surgical fastener. In one embodiment, the first and second legs are curved between the bridge and the respective first and second insertion tips at the distal ends of the legs, and the first and second ribs have curves that mirror the curvature of the first and second legs.
In one embodiment, the first and second legs extend along respective longitudinal axes, and the first and second insertion tips are asymmetrical and skewed outwardly relative to the respective longitudinal axes of the first and second legs.
In one embodiment, a surgical fastener for anchoring medical devices to tissue preferably includes a first leg having a proximal end, a distal end, a first rib extending between the proximal and distal ends of the first leg, and a first insertion tip at the distal end of the first leg, and a second leg having a proximal end, a distal end, a second rib extending between the proximal and distal ends of the second leg, and a second insertion tip at the distal end of the second leg. In one embodiment, a bridge connects the proximal ends of the first and second legs for forming a closed end of the surgical fastener.
In one embodiment, the first and second legs are curved between the bridge and the respective first and second insertion tips at the distal ends of the legs. In one embodiment, the first and second ribs having curves that mirror the curvature of the first and second legs.
In one embodiment, each of the first and second insertion tips have a distal piercing point that defines a distal-most end of the insertion tip. In one embodiment, the distal piercing points are located outside the respective first and second legs.
In one embodiment, the first and second legs extend along respective longitudinal axes, and the first and second insertion tips are asymmetrical and skewed outwardly relative to the respective longitudinal axes of the first and second legs.
In one embodiment, each of the first and second legs preferably has an inner wall, an outer wall facing away from the inner wall, a top surface extending between the inner and outer walls, and a bottom surface extending between the inner and outer walls and facing away from the top surface, whereby the inner walls of the respective first and second legs oppose one another. In one embodiment, the outer walls of the respective first and second legs face away from one another in opposite directions. In one embodiment, the top surfaces of the respective first and second legs face in the same direction and define concave curved surfaces. In one embodiment, the bottom surfaces of the respective first and second legs face in the same direction and define convexly curved surfaces that face away from and in an opposite direction from the concave curved surfaces.
These and other preferred embodiments of the present invention will be described in more detail below.
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In one embodiment, the applicator system 40 includes one or more cartridges 54 that are mounted atop a support base 56 that holds the cartridges. In one embodiment, each cartridge 54 includes a plurality of slots 58 that are accessible at a top surface of the cartridge 54. A single surgical fastener 60 is disposed within each of the slots 58. In one embodiment, each of the cartridges 54 contains a plurality of surgical fasteners 60. The surgical fasteners in one cartridge may have the same properties (e.g., the same size), or the surgical fasteners in one cartridge may be divided into different sections having different properties (e.g., small, medium, and large sizes). In one embodiment, all of the surgical fasteners in a first cartridge may have a first property (e.g., small size), and all of the surgical fasteners in a second cartridge may have a second property (e.g., large size).
In one embodiment, the base 56 and the cartridges 54 may have tongue and groove features that are used for securing the cartridges atop the base 56. In one embodiment, the tongue and groove features are used for releasably securing the cartridges to the base, and for mixing and matching cartridges having surgical fasteners with different properties. The cartridges may be slid over a top surface of the base using the tongue and groove features, which then hold the cartridges in place atop the base.
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In one embodiment, the first and second insertion tips 68, 72 are preferably skewed with respect to longitudinal axes of the respective first and second legs 66, 70. In one embodiment, the insertion tips are skewed outwardly with respect to the longitudinal axes of the first and second legs.
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In one embodiment, the surgical fastener may be made of absorbable and/or non-absorbable materials. Preferred absorbable materials include PDS, PDS/lactide-glycolide blends, PLA, etc. In one embodiment, each surgical fastener is sized to fit inside of a 5 mm outer diameter tube (typically trocar cannula dimension). The surgical fastener is fabricated by molding, however, with small modifications, other processes such as casting, stamping, and machining may be used. In one embodiment, the surgical fasteners may be extruded into a general shape, and then formed.
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Although the present invention is not limited by any particular theory of operation, it is believed that providing an insertion fork with grooved tines that engage ribs on outer surfaces of the legs of a surgical fastener will enhance stability and control of the surgical fastener when dispensing the surgical fastener from the distal end of the applicator instrument. In addition, the insertion force is provided closer to the distal end of the surgical fastener and not only at the proximal end of the surgical fastener as is the case with prior art systems. This feature (i.e. providing insertion force on the surgical fastener near the leading end of the fastener) may enable smaller and/or lower profile surgical fasteners to be used. The insertion fork also provides additional insertion force where the fork engages the bridge of the surgical fastener at the trailing end of the fastener.
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In one embodiment, only one of the first and second ribs 82′, 84′ may have a narrower proximal section and a wider distal section. In one embodiment, both the first and second legs have respective first and second ribs with narrower proximal sections and wider distal sections. In
The insertion forks and surgical fasteners disclosed herein may be incorporated into a wide variety of surgical fastener insertion tools having various features. The applicator instruments may be stand-alone tools or may be combined with other well-known surgical tools.
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In one embodiment, the insertion tool 140 preferably includes an insertion fork 152 secured to the distal end 149 of the body 145. The insertion fork 152 preferably extends laterally relative to the longitudinal axis A1 of the body 145. The insertion fork 152 includes a first tine 198 and a second tine 202 that oppose one another and that are adapted for securing a surgical fastener 60 therebetween. The insertion fork 152 may have one or more of the features disclosed in the embodiment shown in
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Although the present invention is not limited by any particular theory of operation, it is believed that the embodiments shown in
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The insertion tool 240 includes the insertion fork 252 having a first tine 298 and a second tine 302 opposing the first tine. The insertion fork 252 may have one or more of the features disclosed in the embodiment shown in
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Once the surgical fastener 60 is loaded onto the fork 252, the elongated shaft 242 of the insertion tool 240 is clamped between the jaws 167, 169, with the insertion fork 252 extending in a generally perpendicular orientation relative to the longitudinal axis A1 of the needle driver 165. The tines 298, 302 of the insertion fork 252 are advanced into tissue for inserting the surgical fastener 60 into the tissue. The curved elongated shaft 242 of the insertion tool 240 mimics the look, feel, and operational characteristics of a curved suture needle.
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In one embodiment, the insertion fork 452 extends along an axis A5 that is perpendicular to the longitudinal axis A1 of the handle 442. In one embodiment, the insertion fork 452 may extend along an axis that forms an acute or obtuse angle with the longitudinal axis of the handle 442.
In one embodiment, the insertion fork 452 is permanently secured to the distal end 450 of the handle 442. In one embodiment, the tines 498, 452 at the distal end of the fork 452 are inserted into a slot of a cartridge to engage a single surgical fastener between the opposing tines 498, 452. The handle 442 is grasped by surgical personnel and the use of the insertion tool 440 mimics that of a suture needle for inserting the surgical fastener (not shown) into tissue.
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In one embodiment, the elongated shaft 1246 and the insertion fork 1252 are telescopically received within the elongated conduit 1249 of the outer sheath 1247 so that the insertion fork 1252 may be selectively moved between the retracted position shown in
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In one embodiment, the elongated shaft 1346 desirably extends along a zig-zag or multiple curved path to enable the fork 1352 to reach specific anatomical areas of the body. In the particular embodiment shown in
Using cartridges for holding a plurality of surgical fasteners was disclosed above in
In one embodiment, the cartridge 1454 desirably includes a first sidewall 1455, a second sidewall 1465 and a center wall 1475 that extends between the first and second sidewalls 1455, 1465. An elongated slot 1458 extends between the upper ends of the first and second sidewalls 1455, 1465 to provide access to each surgical fastener 60. In one embodiment, the cartridge 1454 preferably has a plurality of elongated slots 1458 extending along the length of the cartridge, with each elongated slot being associated with one of the plurality of surgical fasteners loaded into the cartridge.
In one embodiment, the inner face of the first sidewall 1455 desirably includes a ledge 1457 that is adapted to engage the first barb 74 of the surgical fastener 60. The inner face of the second sidewall 1454 desirably includes a second ledge 1467 that is adapted to engage the second barb 76 of the surgical fastener 60. The first and second ledges 1457, 1467 preferably hold the surgical fastener 60 in place within the cartridge until the surgical fastener is to be removed from the cartridge.
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In one embodiment, the cartridge 1754 preferably includes a top plate 1785 having a plurality of elongated slots 1758 formed therein. Each of the elongated slots 1758 preferably provides access to a single surgical fastener 60 (
In one embodiment, the cartridge 1754 preferably includes a first side channel 1759 that extends along the length of the first lateral sidewall 1755 of the cartridge, and between the first lateral edge of the top plate 1785 and the first rail 1797 of the bottom plate 1795. The cartridge also preferably includes a second side channel 1769 that extends along the length of the second lateral sidewall 1769, and between the second lateral edge of the top plate 1785 and the second bottom rail 1799 of the bottom plate 1795.
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The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description or the claims. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). Similarly, the words “include”, “including”, and “includes” mean including but not limited to. To facilitate understanding, like reference numerals have been used, where possible, to designate like elements common to the figures.
While the foregoing is directed to embodiments of the present invention, other and further embodiments of the invention may be devised without departing from the basic scope thereof, which is only limited by the scope of the claims that follow. For example, the present invention contemplates that any of the features shown in any of the embodiments described herein, or incorporated by reference herein, may be incorporated with any of the features shown in any of the other embodiments described herein, or incorporated by reference herein, and still fall within the scope of the present invention.
The present patent application is a continuation of U.S. patent application Ser. No. 14/177,894, filed Feb. 11, 2014, which claims benefit of U.S. Provisional Application No. 61/784,497, filed Mar. 4, 2013, entitled “APPLICATOR SYSTEMS FOR SURGICAL FASTENERS,” and is related to commonly assigned U.S. Pat. Nos. 8,579,920 and 8,518,055, and U.S. Patent Appln. Publication Nos. US 2010/0292715 (now U.S. Pat. No. 8,894,669), US 2010/0292710 (now U.S. Pat. No. 8,728,098), US 2010/0292713 (now U.S. Pat. No. 8,728,099), US 2011/0079627 (now U.S. Pat. No. 8,920,439), US 2013/0304091 (now U.S. Pat. No. 9,364,228), and US 2013/0218177 (now U.S. Pat. No. 9,055,945), the disclosures of which are hereby incorporated by reference herein.
Number | Date | Country | |
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61784497 | Mar 2013 | US |
Number | Date | Country | |
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Parent | 14177894 | Feb 2014 | US |
Child | 16049871 | US |