MX368461B

Surgical fasteners having articulating joints and deflectable tips.

Abstract

A surgical fastener for securing a prosthetic device to a tissue includes a first leg having a proximal end, a distal end, a first insertion tip at the distal end and a first articulating joint that separates said first leg into a proximal segment and a distal segment that is deviable in relation to the proximal segment, and a second leg that includes a proximal end, a distal end and a second insertion tip at the distal end, and a second articulating joint that separates said second leg into a proximal segment and a distal segment that is deflectable in relation to the proximal segment; a bridge connects the proximal ends of the first and second legs to form a closed end of the surgical fastener; After implantation in the tissue, the insertion tips are deviable away from the vessels and nerves to minimize injury to the vessels and nerves, and to minimize patient discomfort and pain.

MX368461B, drawing sheet 1 — Sheet 1 of 50

Term

7.4 yearsleft in the term

Expires 20 February 2034.

19 claims: 3 independent, 16 dependent

1
5 1. Una grapa quirúrgica que comprende:una primera pata que induye un extremo próxima!, un extremo distal, una primera punta de inserción en eí extremo distai de ia primera pata, la punta de inserción teniendo una longitud, y una primera junta de articulación que separa la primera pata en un segmento proximal y un segmento distal que se puede desviar con relación al segmento proximal de la primera pata, en donde la primera 10 pata tiene una pared externa y una primera guía de alineamiento que se extiende a lo largo de la pared externa de la primera pata;una segunda pata que induye un extremo proximal, un extremo distal, una segunda punta de inserción en el extremo distal de la segunda pata, la segunda punta de inserción teniendo una longitud y una segunda junta de articulación que separa la segunda pata 15 en un segmento proximal y un segmento distal que se puede desviar con relación al segmento proximal de la segunda pata, en donde la segunda pata tiene una pared externa que da la espalda a la pared externa de la primera pata y una segunda guía de alineamiento que se extiende a lo largo de la pared externa de la segunda pata;ias primera y segunda patas se extienden a lo largo de ejes longitudinales 20 respectivos, en donde la mayoría de la longitud de la primera y segunda puntas de inserción son asimétricas y se bifurcan hacia fuera con relación a los ejes longitudinales respectivos de las primera y segunda patas en ambos estados desviado y sin desviar;un puente que conecta los extremos proximales de las primera y la segunda patas para formar un extremo cerrado de la grapa quirúrgica. 25
2
La grapa quirúrgica de conformidad con la reivindicación 1, caracterizada además porque la primera punta de inserción tiene un primer punto distal en un extremo más distal de la primera pata y la segunda punta de inserción tiene un segundo punto distal en un extremo más dista! de la segunda pata.
3
La grapa quirúrgica de conformidad con la reivindicación 2, caracterizada 30 además porque la distancia entre los primer y segundo puntos distales es mayor que la distancia entre las paredes externas de las primera y segunda patas que se dan la espalda una de la otra en direcciones opuestas.
4
La grapa quirúrgica de conformidad con la reivindicación 2, caracterizada además porque la primera punta de inserción comprende un extremo próxima! que incluye una 35 primera superficie de apoyo de la herramienta de inserción que está más cerca del extremo distal de la primera pata que del extremo proximal de la primera pata, y !a segunda punta de inserción comprende un extremo proximal que incluye una segunda superficie de apoyo de la herramienta de inserción que está más cerca del extremo distal de la segunda pata que del extremo proximal de la segunda pata.
5
La grapa quirúrgica de conformidad con la reivindicación 4, caracterizada además porque la primera junta de articulación se ubica entre la primera superficie de apoyo de la herramienta de inserción y el extremo proximal de la primera pata, y la segunda junta de articulación se ubica entré la segunda superficie de apoyo de la herramienta de inserción y el extremo proximal de la segunda pata.
6
La grapa quirúrgica de conformidad con la reivindicación 4, caracterizada además porque la primera junta de articulación se ubica entre la primera superficie de apoyo de la herramienta de inserción y el primer punto distal en el extremo más distal de la primera pata, y la segunda junta de articulación se ubica entre la segunda superficie de apoyo de la herramienta de inserción y el segundo punto distal en el extremo más distal de la segunda pata.
7
La grapa quirúrgica de conformidad con la reivindicación 4, caracterizada además porque !a primera superficie de apoyo de la herramienta de inserción se orienta hada ei extremo proximal de la primera pata, y la segunda superficie de apoyo de la herramienta de inserción se orienta hacia el extremo proximal de ia segunda pata.
8
La grapa quirúrgica de conformidad con la reivindicación 4, caracterizada además porque la primera guia de alineamiento que se extiende entre el extremo proximal de la primera pata y la primera superficie de apoyo de la herramienta de inserción, y la segunda guía de alineamiento que se extiende entre el extremo proximal de la segunda pata y la segunda superficie de apoyo de la herramienta de inserción.
9
La grapa quirúrgica de conformidad con la reivindicación 8, caracterizada además porque la primera guía de alineamiento en la primera pata tiene un extremo distal que termina y se alinea, sustancialmente, con ia primera superficie de apoyo de la herramienta de inserción, y la segunda guía de alineamiento en la segunda pata tiene un extremo dístal que termina y se alinea, sustancialmente, con la segunda superficie de apoyo de la herramienta de inserción.
10
La grapa quirúrgica de conformidad con la reivindicación 8, caracterizada además porque la primera guía de alineamiento se extiende a través de ia primera junta de articulación y la segunda guía de alineamiento se extiende a través de la segunda junta de articulación.
11
La grapa quirúrgica de conformidad con la reivindicación 1, caracterizada además porque la primera pata comprende una primera lengüeta que sobresale hacia el extremo proximal de ia primera pata y la segunda pata comprende una segunda lengüeta que sobresale hacia el extremo proximal de la segunda pata, y en donde la primera y la segunda lengüetas se proyectan alejándose entre sí.
12
La grapa quirúrgica de conformidad con la reivindicación 1, caracterizada además porque comprende adicionalmente un elemento tensor que se extiende entre los extremos proximales de la primera y segunda patas y se separa desde un lado distal del puente.
13
Una grapa quirúrgica para el anclaje de dispositivos médicos al tejido que comprende:una primera pata que tiene un extremo proximal, un extremo dístal, una pared externa, una primera guía de alineamiento que se extiende a lo largo de la pared externa entre los extremos proximal y dístal de la primera pata, y una primera punta de inserción en el extremo distal de la primera pata, la primera punta de inserción teniendo una longitud;una segunda pata que tiene un extremo proximal, un extremo dista!, una pared externa que mira al sentido contrario de la pared externa de la primera pata, una segunda guía de alineamiento que se extiende a lo Sargo de la pared externa de la segunda pata entre los extremos proximal y dístal de la segunda pata, y una segunda punta de inserción en el extremo distal de la segunda pata, la segunda punta de inserción teniendo una longitud;al menos una de las patas tiene una junta de articulación ubicada entre los extremos proximal y dista! de esta que permite que la punta de inserción asociada con al menos una de las patas se desvíe con relación al extremo proximal de esta;la primera y segunda patas se extienden a lo largo de respectivos ejes longitudinales, en donde la mayoría de la longitud de la primera y segunda puntas de inserción son asimétricas y se bifurcan hacia fuera con relación a los ejes longitudinales respectivos de las primera y segunda patas en ambos estados desviado y sin desviar;y un puente que conecta los extremos proximales de las primera y segunda patas para formar un extremo cerrado de la grapa quirúrgica.
14
La grapa quirúrgica de conformidad con la reivindicación 13, caracterizada además porque comprende adícionalmente:una primera junta de articulación ubicada entre los extremos proximal y distai de la primera pata que separa la primera pata en un segmento proximal y un segmento distal que se desvía con relación al segmento proximal;y una segunda junta de articulación ubicada entre los extremos proximal y distal de la segunda pata que separa la segunda pata en un segmento proximal y un segmento distal que se puede desviar con relación al segmento proximal.
15
La grapa quirúrgica de conformidad con la reivindicación 14, caracterizada además porque comprende adicionalmente:la primera punta de inserción que incluye un extremo proximal que tiene una primera superficie de apoyo de la herramienta de inserción y un extremo distal que incluye un primer punto dístal, en donde la primera junta de articulación se ubica entre la primera superficie de apoyo de la herramienta de Inserción y el primer punto distal;y la segunda punta de inserción que incluye un extremo proximal que incluye una segunda superficie de apoyo de la herramienta de inserción y un extremo dista! que incluye un segundo punto distal, en donde ia segunda junta de articulación se ubica entre la segunda superficie de apoyo de la herramienta de inserción y el segundo punto distai,
16
La grapa quirúrgica de conformidad con la reivindicación 15, caracterizada además porque comprende adidonalmente:la primera pata que tiene una primera lengüeta que se proyecta hacia el extremo proximal de la primera pata, en donde el primer punto dista! se puede desviar con relación a la primera lengüeta medíante la primera junta de articulación;y la segunda pata que tiene una segunda lengüeta que se proyecta alejándose de la primera lengüeta y hacia el extremo proximal de la segunda pata, en donde la segunda punta distal se puede desviar con relación a ia segunda lengüeta mediante la segunda junta de articulación,
17
La grapa quirúrgica de conformidad con la reivindicación 14, caracterizada además porque la primera junta de articulación comprende una sección de diámetro transversal reducida de la primera pata, y la segunda junta de articulación comprende una sección de diámetro transversal reducida de la segunda pata.
18
Una grapa quirúrgica para el anclaje de dispositivos médicos al tejido que comprende:una primera pata que incluye un extremo proximal, un extremo dista!, una pared externa que se extiende entre los extremos proximal y distal, una primera guía de alineamiento que te extiende a lo largo de la pared externa de la primera pata, una primera punta de inserción en el extremo distal de la primera pata, la primera punta de inserción teniendo una longitud, y una primera Junta de articulación que permite que la primera punta de inserción se desvíe con relación al extremo próxima! de la primera pata;una segunda pata que tiene un extremo proximal, un extremo dista!, una segunda punta de inserción en el extremo distal de la segunda pata, la segunda punta de inserción teniendo una iongitud, una pared externa que se extiende entre ios extremos proximal y dista! que da ía espalda a la pared externa de ía primera pata, una segunda guia de alineamiento que se extiende a lo largo de la pared exterior de la segunda pata, y una segunda junta de articulación que permite a la segunda punta de inserción desviarse con relación al extremo próxima! de ía segunda pata;ia primera y segunda pata se extienden a lo largo de respectivos ejes longitudinales, en donde la mayoría de la longitud de las primera y segunda puntas de inserción son asimétricas y se bifurcan hacia fuera con relación a los ejes longitudinales respectivos de ias primera y segunda patas en ambos estados desviado y sin desviar;y 5 un puente que conecta los extremos proxímates de las primera y la segunda patas para formar un extremo cerrado de la grapa quirúrgica.
19
19, La grapa quirúrgica de conformidad con la reivindicación 18, caracterizada además porque ia primera punta de inserción tiene una primera superficie de apoyo de la herramienta de inserción que tiene una forma curva y la segunda punta de inserción tiene una 10 segunda superficie de apoyo de la herramienta de inserción que tiene ona forma curva, y en donde cada una de la primera y segunda puntas de inserción tienen un punto de perforación distal que define un extremo más distal de la punta de inserción, y en donde la distancia entre ios puntos de perforación distales es mayor que la distancia entre las paredes externas de la primera y segunda patas respectivas que se dan la espalda una de la otra en direcciones opuestas.

Independent claims19

326 paragraphs in 3 sections, as filed

SURGICAL STAPLES WITH JOINT JOINTS AND DEVIABLE POINTS CROSSED REFERENCE WITH RELATED REQUESTS

This application is a partial continuation of US Patent Application No. 12 / 464,143, filed on May 12, 2009, the description of which is incorporated herein by reference.

Field of the Invention

The present invention generally relates to surgical staples and, more specifically, relates to applicator instruments, systems, and methods for applying surgical staples.

Background of the Invention

Hernia is a condition where a small loop of the intestine protrudes through a weak point or defect within the wall of a patient's abdominal muscle or groin. This condition is common in humans, particularly men. Hernias of this type can be a consequence of a congenital defect with which the patient is born or they can be due to exertion or to lifting heavy objects. Lifting heavy objects has been known to create a great deal of tension in the abdominal wall and can cause a rupture or tear in a weak spot in the abdominal muscles to create the defect or opening. In either case, the patient may be left with an unsightly lump of intestinal tissue protruding through the defect, which can result in pain, reduced lifting capacity, and in some cases, strangulation of the intestines or possibly other complications. if the blood flow is cut off in the prominent tissue.

A common solution to the problem described above 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 needed due to the network of blood vessels and nerves that exist in the area of a typical defect, requiring a surgeon to perform hernia repair with great skill and care. Within this area can be found vascular structures such as gastric blood vessels, external iliac blood vessels, and lower epigastric blood vessels, as well as reproductive blood vessels, such as the vas deferens that extends through the inguinal floor.

Once the surgeon is familiar with a patient's anatomy, the surgeon carefully places the viscera back into the patient's abdomen through the defect. Repair of the defect may involve closing the defect with sutures or staples, but generally involves placing a surgical prosthesis, such as a mesh patch, over the open defect and fitting the mesh patch to the abdominal wall or groin floor with conventional suture threads or surgical staples. The mesh patch acts as a barrier and prevents expulsion of the intestine through the defect. Suturing the mesh patch to the inguinal floor can be very suitable for open procedures but can be much more difficult and time consuming with endoscopic procedures. With the adoption of endoscopic surgery, endoscopic surgical instruments can be used to apply surgical staples. However, inguinal floor tissue can present special difficulties for the surgeon when a needle or staple is used to penetrate structures, such as Cooper's ligament.

There are currently a wide variety of surgical instruments and staples available for the surgeon to use in an endoscopic or open procedure to attach the mesh patch to the groin floor. One of the first types of endoscopic surgical instruments used is a surgical stapler. A plurality or stack of these non-formed staples can generally be contained within a staple cartridge in series and can be sequentially driven or supplied into the instrument by a spring mechanism. A secondary valve or supply mechanism can be used to separate the most distal staple from the stack, to keep the remainder of the stack charged in the spring, and can be used to supply the most distal staples into the staple forming mechanism. . Delivery mechanisms of this type are found in United States Patent Nos. 5,470,010 and 5,582,616 issued to Rothfuss et al.

Another instrument for attaching the mesh to the hernia uses a helical wire staple that resembles a small section of the spring. Multiple staples of helical wire can be stored in series within the 5mm shank and can be spirally rotated or rotated within the tissue. A loading spring can be used to deflect or supply the plurality of helical staples distally within the stem. A protrusion extends into the stem to avoid possible ejection of the staple stack by the load bearing and may allow a rotating staple to pass through. Instruments and staples of this type are found in United States Patent Nos. 5,582,616 and 5,810,882 issued to Bolduc et al., And in U.S. Patent No. 5,830,221 issued to Stein et al.

Since the aforementioned surgical instruments can be used for hernia restraint applications, they use a spring mechanism to supply a plurality of staples through the surgical instrument. Spring mechanisms typically use a long flexible coil spring to push a stack of staples through a guide or tread into the stem of the surgical instrument. These types of delivery mechanisms can generally be simple and reliable, but may require an additional secondary valve mechanism or protrusion to separate and supply a staple from the stack.

Other surgical staples can be used to secure the mesh to the hernia, but either a single-charge rechargeable instrument or a rotary magazine with a small number of staples capacity is used. This type of surgical fixation instrument can be found in US Patent Nos. 5,203,864 and 5,290,297, both awarded to Edward Phillips. These instruments have not been accepted by the surgical community, possibly due to their single charge capacity and the large size of the rotary magazine that could limit the use of the instrument only for an open procedure.

Since all of the above surgical instruments can be used for hernia restraint applications, they use either a spring mechanism to supply a plurality of staples by means of the surgical instrument or a rotary magazine rather than a delivery mechanism. There may be other types of surgical staples available, such as surgical staples, and they can use delivery mechanisms that do not require the use of a spring to deliver the fasteners distally. An alternate delivery mechanism is described in United States Patent Nos. 5,601,573; 5,833,700; and 5,921,997 issued to Fogelberg et al. Fogelberg et al. References describe a fastener applicator having a delivery mechanism that uses an alternating supply bar to supply a stack of fasteners in series. A supply shoe can be operably hooked and moved with the distally moving supply bar and can be hooked to slide down the proximally moving supply bar. Therefore, the supply shoe can command or push the stack of fasteners stacked distally with the supply bar moving distally and held fixed relative to the supply bar moving proximally. In addition, a valve mechanism may be required to separate the most distal clip from the stack and hold the stack fixed as the most distal clip can be applied to the blood vessel. Although the Fogelberg et al. References describe an alternating delivery mechanism with a single alternating element, they do not explain the use of the fastener applicator in fixation of the mesh in the hernia, nor do they explain the individual activation or delivery of each fastener by means of a mobile member.

Another staple delivery mechanism that uses alternation is that described in US Patent No. 4,325,376 to Klieman et al. A fastener applicator is disclosed which stores a plurality of fasteners in series within a fastener magazine. The fasteners are located in a stack where the most proximal fastener can be pushed or delivered distally by means of a ratchet that can be driven or distally ordered by an alternating member or ratchet blade with each activation of the instrument. As the pawl orders distally, you can push the stacked fasteners distally. Furthermore, a secondary valve mechanism can be described. Therefore, the Klieman et al. Delivery mechanism teaches the use of a single alternating element and ratchet to push or supply the distally stacked fasteners and may require a secondary valve mechanism to supply the most distal fastener.

United States Patent No. 3,740,994 issued to DeCarlo Jr. describes a new alternating supply mechanism that can order a plurality of clips or fasteners and can prepare them for discharge by alternating one of a pair of opposing leaf spring units. The staples reside in series within a guide channel with a fixed leaf spring unit extending in the plane of the guide channel. An alternating leaf spring unit can extend in the opposite direction into the fixed leaf spring unit. As the alternating leaf spring unit moves distally, each of the unit's individual leaf springs can engage a staple and move it distally. The distally moving staples deflect the individual leaf springs from the fixed leaf spring unit and the deflected leaf springs can return to the non-deviated position after the clip has passed. As the movable leaf spring unit moves proximally, the leaf springs of the fixed leaf spring unit keep the staples fixed and prevent them from moving proximally. A guide channel and secondary valve mechanism can be provided to separate a single staple from the stack for formation, and the staple stack can be held fixed while forming the single fastener.

Furthermore, similar delivery mechanisms are described in United States Patent No. 4,478,220 issued to DiGiovanni et al. And U.S. Patent No. 4,471,780 to Rothfuss and others. Both related patents describe an alternate delivery mechanism that uses a fixed member and an alternate member to supply or order a plurality of fasteners distally. The angled flexible fingers can be hingedly attached to the alternating member and operatively engaged with the fasteners when moved distally and slidably with the fasteners when moved proximally. The angled flexible fingers within the stationary member deviate out of the way as the fasteners move distally and are lifted to stop proximal motion of the fastener after the fastener passes. In addition, a secondary valve mechanism is described.

United States Patent Application Publication No. 2002/0068947, the disclosure of which is incorporated herein by reference, discloses a device for administering a plurality of individual surgical staples. In one embodiment, the delivery device includes a drive mechanism with distal and proximal ends. The drive mechanism has a movable member and an opposite fixed member, whereby the movable member can be moved proximally and distally with respect to the delivery device. The movable member has a sharp distal end to pierce tissue. The device includes at least one surgical staple disposed between the first element and the second members. The at least one surgical staple has a proximal end and a distal end. The device further has an actuator having at least two sequential positions. A first position to move the movable member distally and pierce the tissue and a second position to move the movable member proximally to apply the distal end of the clip.

Tacks to fix the meshes used in laparoscopy have generally been made of metal, such as stainless steel, nitinol or titanium. Metal studs were necessary to provide sufficient holding strength, penetration of various prosthetic meshes, and to facilitate fabrication. Until recently, there were no absorbable tacks available on the market, and surgeons were only able to use absorbable sutures to provide a means of fixation that did not permanently remain in the body. However, the use of suture threads is extremely difficult for the laparoscopic procedure, so they are generally not used unless the repair is performed openly. With surgical trends that tend to apply more minimally invasive techniques with minimal foreign body buildup, an absorbable tack with a minimal profile that can be applied laparoscopically is needed.

Despite the progress mentioned above, the need for further improvements persists. In particular, there is still a need for surgical staples that have a minimal profile, that can be applied laparoscopically, and surgical staples that are absorbable.

BRIEF DESCRIPTION OF THE INVENTION

In one embodiment, a surgical staple includes a first leg having a proximal end, a distal end, a first insertion tip at the distal end of the first leg, and a first hinge joint that separates the first leg into a proximal segment and a distal segment that can deviate relative to the proximal segment of the first leg, and a second leg that has a proximal end, a distal end, a second insertion tip at the distal end of the second leg, and a second hinge joint that separates the second leg into a proximal segment and a distal segment that can deviate from the proximal segment of the second leg. In one embodiment, the first insertion tip has a first distal point at a more distal end of the first leg, and the second insertion point has a second distal point at a more distal end of the second leg. In one embodiment, a bridge preferably connects the proximal ends of the first and second legs to form a closed end of the surgical clip.

As used in this description, the term joint joint is intended to mean a functional zone that is capable of articulating or translating and that is intended to aarcate the rotation of one segment relative to another segment, compression of one leg and / or lengthening of a leg. In one embodiment, providing a surgical staple having a leg with a hinge joint means that a distal leg segment is capable of rotating 360 ° relative to the proximal leg segment, that the distal leg segment is capable of deviate in any lateral direction relative to the proximal leg segment, that the distal segment may compress to the proximal leg segment along the longitudinal axis of the leg, and that the leg can be lengthened whereby the proximal and distal segments of the leg are separated from each other along the longitudinal axis of the leg. In one embodiment, the articulation joint itself may be compressed between the proximal and distal segments of the leg. In one embodiment, the articulation joint can be stretched to allow leg lengthening. In one embodiment, the proximal segment, the articulation joint, and the distal segment are made of the same material, such as a biocompatible polymer material.

In one embodiment, the first insertion tip has a proximal end that includes a first surface for seating the insertion tool that is closer to the distal end of the first leg than the proximal end of the first leg, and the second insertion tip has a proximal end that includes a second surface for seating the insertion tool that is closer to the distal end of the second leg than to the proximal end of the second leg. In one embodiment, the first joint joint is preferably located between the first bearing surface of the insertion tool and the proximal end of the first leg, and the second joint joint is preferably located between the second joint surface. support of the insertion tool and the proximal end of the second leg.

In one embodiment, the first joint joint is located between the first bearing surface of the insertion tool and the first distal point at the most distal end of the first leg, and the second joint joint is located between the second joint surface. support of the insertion tool and the second distal point at the most distal end of the second leg.

In one embodiment, the first leg has a first alignment guide extending between the proximal end of the first leg and the first surface to seat the insertion tool, and the second leg has a second alignment guide extending between the proximal end of the second leg and the second surface to seat the insertion tool. In one embodiment, the first alignment guide on the first leg has a distal end terminating in and substantially aligned with the first bearing surface of the insertion tool, and the second alignment guide on the second leg has a distal end ending at and substantially aligned with the second bearing surface of the insertion tool. In one embodiment, the first alignment guide extends through the first link joint and the second alignment guide extends through the second link joint.

In one embodiment, a surgical clip includes a tensioning element between the proximal ends of the first and second legs and is detached from a distal side of the bridge. The tensioning element preferably applies tension to a prosthetic device if a gap remains between the bridge and the prosthetic device after the surgical clip is inserted into the tissue.

In one embodiment, a surgical staple for attaching medical devices to tissue preferably includes a first leg having a proximal end, a distal end, a first alignment guide 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 alignment guide extending between the proximal and distal ends of the second leg, and a second insertion tip at the distal end of the second leg. At least one of the legs preferably has a hinge joint located between the proximal and distal ends thereof which allows the insertion tip associated with at least one of the legs to deviate relative to the proximal end thereof. A bridge preferably connects the proximal ends of the first and second legs to form a closed end of the surgical clip.

In one embodiment, a first hinge joint is located between the proximal and distal ends of the first leg to separate the first leg into a proximal segment and a distal segment that deviates from the proximal segment. In one embodiment, a second joint joint is located between the proximal and distal ends of the second leg to separate the second leg into a proximal segment and a distal segment that deviates relative to the proximal segment.

In one embodiment, the first insertion tip preferably includes a proximal end that has a first bearing surface of the insertion tool and a distal end that includes a first distal point, whereby the first articulation joint is located between the first bearing surface of the insertion tool and the first distal point. In one embodiment, the second insertion tip preferably includes a proximal end that includes a second bearing surface of the insertion tool and a distal end that includes a second distal point, whereby the second joint joint is located between the second bearing surface of the insertion tool and the second distal point.

In one embodiment, the first leg preferably has a first tab projecting toward the proximal end of the first leg, whereby the first distal point of the first insertion tip is deviated from the first tab by the first articulation joint. In one embodiment, the second leg preferably has a second tab projecting away from the first tab and toward the proximal end of the second leg, whereby the second distal tip is deflected relative to the second tab by the second articulation joint.

In one embodiment, the first link joint comprises a reduced cross section diameter of the first leg, and the second link joint comprises a reduced cross section diameter of the second leg.

In one embodiment, a surgical staple for attaching medical devices to tissue preferably has a first leg with a proximal end, a distal end, a first insertion tip at the distal end of the first leg, and a first joint joint that allows the first insertion tip to deviate relative to the proximal end of the first leg, and a second leg having a proximal end, a distal end, a second insertion tip at the distal end of the second leg, and a second hinge joint that allows the second insertion tip to deviate relative to the proximal end of the second leg. Preferably, a bridge connects the proximal ends of the first and second legs to form a closed end of the surgical clip. In one embodiment, the first insertion tip preferably has a first insertion tool bearing surface with a curved shape and the second insertion tip has a second insertion tool bearing surface with a curved shape, for so each of the first and second insertion tips has a distal piercing point that defines a more distal end of the insertion tip. In one embodiment, the distance between the distal piercing points is greater than the distance between the outer walls of the first and second legs that are oriented in the opposite direction from each other.

In one embodiment, the present invention describes an applicator instrument and methods for consistently applying surgical staples. In one embodiment the applicator instrument is used to hold a prosthetic device, such as a surgical mesh, in place on the tissue. In one embodiment the applicator instrument includes a mechanism for placing a surgical staple in-line with a trigger rod. The applicator instrument preferably includes a firing system that initially advances the activation rod toward the surgical clip with a first speed. In one embodiment, the trigger system can store energy if the trigger rod is advanced or directed toward the surgical clip. It is desirable for the trigger system to engage the surgical clip with the trigger rod while holding the surgical clip in a fixed position. The trigger system preferably releases the stored energy to drive the trigger rod at a second speed that is greater than the first speed to apply the surgical clip to the tissue. In one embodiment, a surgical clip is delivered during one cycle of the trigger system. It is possible to supply a plurality of surgical clips to secure a prosthesis, such as a surgical mesh, to the tissue.

In one embodiment an applicator instrument for supplying surgical staples preferably includes a housing and an elongated stem extending from the housing having a proximal end attached to the housing and a distal end far therefrom. It is preferred that the applicator instrument include a trigger system to deliver surgical staples from the distal end of the elongated stem. The firing system preferably includes a firing rod disposed on the elongated shaft and preferably has a firing cycle with a first stage to drive the firing rod toward the distal end of the elongated shaft at a first speed ratio and a second stage to drive the firing rod toward the distal end of the elongated stem at a second speed ratio greater than the first speed ratio.

In one embodiment, a distal end of the trigger rod includes an insert fork. The applicator instrument is adapted to slowly direct the insertion fork toward an initial surgical staple followed by rapid firing of the surgical staple through the prosthetic device and into the tissue. The prior art devices rapidly advance a push element in a single motion through a staple in a hammer-like manner while continuing to drive the staple into the tissue or engage the staple at the same speed to slowly propel the staple into the tissue. The first type of prior art device is limited in its ability to securely engage the staple to ensure proper insertion of the staple into tissue. The first prior art device such as hammer may further damage the surgical clip due to impact force or may require the use of a massive clip adapted to withstand impact forces. The second type of prior art device does not advance the staple fast enough to prevent tissue folding and allow adequate tissue penetration. These two prior art approaches do not lend themselves to consistent and repeatable penetration of the staple into tissue. In one embodiment, the present invention overcomes these limitations by slowly directing an insertion fork toward an initial surgical clip to ensure proper engagement of the insertion fork with the surgical clip. After proper engagement, the present invention further provides rapid firing of the surgical clip through a prosthetic device and into the tissue. As a result, each surgical staple is preferably inserted in the same manner regardless of the speed at which the user pulls the trigger.

In one embodiment, the distal end of the firing rod engages with at least one of the surgical clips during the first stage of the firing cycle, and the distal end of the firing rod supplies at least one of the surgical clips from the distal end of the elongated stem during the second stage of the firing cycle. The firing system may include an energy storage element, such as a firing spring attached to the firing rod, whereby the firing system is adapted to store energy in the firing spring prior to the second stage of firing cycle and transfers the stored energy from the firing spring to the firing rod during the second stage of the firing cycle. In certain embodiments, the energy storage element may further include a pneumatic device, a hydraulic device, and / or a compressed gas device.

In one embodiment, the applicator instrument includes an actuator movable between a first position and a second position to activate the trigger system. The actuator can be a squeeze trigger that activates the trigger system. In one embodiment, the trigger spring is compressed at least partially before the first stage of the trigger cycle and the trigger rod advances distally at a rate proportional to the movement of the actuator during the first stage of the trigger cycle. The trigger spring is preferably compressed to store energy therein as the actuator moves from the first position to the second position. The energy stored in the trigger spring is released during the second stage of the trigger cycle to rapidly propel the trigger rod toward the distal end of the elongated stem. Although many of the embodiments described in the present invention relate to a trigger spring, it is contemplated that it is possible to use other energy storage devices such as those described above and still fall within the scope of the present invention.

In one embodiment, the firing system preferably includes a release latch that prevents the firing rod from moving toward the distal end of the elongated stem after the first stage of the firing cycle and before the second stage of the firing cycle. Shooting. At a preferred stage of the firing cycle, and preferably after energy is stored in the firing system, the release latch preferably releases the firing rod to move distally.

In one embodiment the applicator instrument may include an impeller attached to the actuator and extending through the elongated stem to drive the surgical staples toward the distal end of the elongated stem. The impeller is preferably adapted to move toward the distal end of the elongated stem as the actuator moves from the first position to the second position. The impeller is preferably adapted to move toward the proximal end of the stem as the actuator moves from the second position to the first position. Preferably, the driver includes a plurality of driver projections projecting toward the distal end of the driver and each is adapted to engage one of the surgical clips to drive the surgical clips to the distal end of the elongated stem.

In one embodiment, the surgical clips are arranged within the elongated shaft to be driven toward the distal end of the elongated shaft by the driver. In one embodiment, the most distal surgical staple is engaged by the stacking unit to align the most distal surgical staple with the distal end of the trigger rod. In one embodiment, the distal end of the trigger rod includes an insertion fork having spaced teeth adapted to engage the most distal surgical clip.

In one embodiment, a surgical staple includes a first leg having a distal end with a first insertion tip, a proximal end, and a first surface for seating the insertion tool adjacent the first insertion tip. The surgical staple includes a second leg having a distal end with a second insertion tip, a proximal end, and a second surface for seating the insertion tool adjacent the second insertion tip. Preferably, the surgical staple further includes a bridge connecting the proximal ends of the first leg and the second leg for the formation of a closed proximal end of the surgical staple. In one embodiment, the teeth of an insertion fork can preferably be accommodated against the surfaces of the first and second positioning surfaces of the surgical clip insertion instrument to apply an insertion force with the surgical clip in place. closer to the distal end of the surgical clip than to the proximal end of the surgical clip.

In one embodiment, an applicator instrument may include a locking system attached to the trigger system to prevent operation of the trigger system after all surgical clips have been delivered. In one embodiment, the locking system secures an actuator or trigger in a closed position after all surgical clips have been delivered.

In one embodiment, an applicator instrument for supplying the surgical staples includes a housing having a handle section and a trigger, as well as an elongated stem for supplying the surgical staples. The elongated stem includes a proximal end attached to the housing and a distal end away from it. The elongated stem may include a surgical staple supply conduit extending therethrough to distribute or supply the surgical staples from the distal end of the elongated stem. The applicator instrument preferably includes a trigger operable trigger system, whereby the trigger system includes a trigger rod and an energy storage unit attached to the trigger rod. In one embodiment, the firing system preferably has a firing cycle that includes a first stage to move the firing rod toward the distal end of the elongated stem at a first rate and a second stage to transfer power from the storage unit of energy to the firing rod to drive the firing rod toward the distal end of the elongated stem at a second speed that is greater than the first speed. In one embodiment, energy can be stored in the energy storage unit during the initial steering stage when the trigger rod is moved forward at the first speed.

In one embodiment, the applicator instrument may include a stacking unit arranged within the elongated stem to align the surgical staples with a distal end of the trigger rod. The surgical clips preferably advance through an elongated conduit in the elongated shaft and to the distal end of the elongated shaft. The applicator instrument may include an impeller attached to the trigger system to progressively propel the surgical clips to the distal end of the elongated stem each time the trigger is depressed. In one embodiment, the trigger rod preferably moves distally as the trigger is depressed from an open position to a closed position and the trigger rod moves proximally as the trigger returns from the position. closed to the open position.

In one embodiment, a method of supplying surgical staples includes providing an applicator instrument having a housing, an elongated stem protruding from the housing, and a firing system including a firing rod to supply the surgical staples from a distal end of the stem. elongate. The method preferably includes aligning a first surgical clip with a distal end of the trigger rod, propelling the distal end of the trigger rod toward the first surgical clip at a first speed to engage the surgical clip after the advancement step of the firing rod and while preventing the firing rod from moving towards the distal end of the elongated rod, storing energy in the firing system. The method preferably includes releasing the firing rod for distal movement and transferring the stored energy to the firing rod to drive the firing rod distally at a second speed that is greater than the first speed in order to deliver the first surgical or initial staple from the distal end of the elongated stem.

In one embodiment, the trigger system preferably includes a compressible trigger spring attached to the trigger rod and an actuator attached to the trigger spring to selectively compress the trigger spring to store energy in the trigger system. In one embodiment, the energy to drive the trip rod is stored in a spring. In one embodiment, the spring is a trigger spring, preferably preloaded or precompressed prior to activation of the applicator instrument.

In one embodiment, the applicator instrument includes a locking mechanism to prevent operation of the applicator instrument when there are no longer any surgical clips available (eg, if all surgical clips have already been supplied). In one embodiment, the locking mechanism preferably secures the trigger in a closed position when the device is empty. The locking mechanism may further include a mechanical or electronic counter showing how many surgical clips have been supplied and / or how many surgical clips are available.

In one embodiment, the distal end of the applicator instrument, such as the distal end of the elongated stem, includes one or more orientation marks. The distal end of the elongated stem may further include one or more properties on the distal tip to aid in orientation of the device and / or to capture one or more strands of the mesh. In one embodiment, the applicator instrument includes one or more protuberances to capture one or more strands of the mesh.

In one embodiment, a surgical staple includes a first leg having a distal end, a proximal end, and a first insertion tip at the distal end of the first leg. The surgical staple preferably includes a second leg having a distal end, a proximal end, and a second insertion tip at the distal end of the second leg. Preferably, a bridge connects the proximal ends of the first and second legs to form a closed end of the surgical clip. The first insertion tip preferably includes a first surface for placement of the insertion instrument and the second insertion tip preferably includes a second surface for seating the insertion tool.

In one embodiment, the first and second legs extend along the respective longitudinal axes and the Insertion tips, first and second, are biased or angled outward relative to the respective longitudinal axes of the first and second legs. Accordingly, in one embodiment, the space between the insertion tips is greater than the space between the first and second legs, which can improve the capture of strands or fibers between the legs. In one embodiment, at least one of the first or second insertion tips includes a blunt distal piercing point. In one embodiment, both insertion tips, first and second, include blunt distal drill points.

In one embodiment, the first insertion tip includes a proximal end of the first insertion instrument placement surface and the second insertion tip includes a proximal end that includes the second surface for seating the insertion tool. In one embodiment, the first surface for seating the insertion tool is closer to the distal end of the first leg than the proximal end of the first leg, and the second surface for seating the insertion tool is closer to the distal end of the second leg leg than the proximal end of the second leg. The first and second surfaces for seating the insertion tool are preferably oriented toward the proximal ends of the respective first and second legs and are adapted to engage the distal end of an insertion tool, such as the distal ends of the teeth of an insert fork.

In one embodiment, the first surface for seating the insertion tool includes an opening facing the proximal end of the first leg and the second surface for seating the insertion tool includes a second opening facing the proximal end of the second leg. The openings in the surfaces for seating the insertion tool may be blind openings that close at one end (eg, at the distal end). In one embodiment, the first surface for seating the insertion tool includes a first opening that extends completely through the first insertion tip and the second surface for seating the insertion tool includes a second opening that extends completely through the second insertion tip.

In one embodiment, the first leg of a surgical staple preferably includes a first alignment guide extending between the proximal end of the first leg and the first surface to seat the insertion tool, and the second leg preferably includes a second alignment guide extending between the proximal end of the second leg and the second surface to seat the insertion tool. The first alignment guide for the first leg is preferably in substantial alignment with the first surface for seating the insertion tool, and the second alignment guide for the second leg is preferably in substantial alignment with the second surface to seat the insertion tool. The first and second alignment guides may include grooves that extend between the distal and proximal ends of the legs, ribs that extend between the distal and proximal ends of the legs, or a combination of grooves and ribs.

In one embodiment, the first and second insertion tips have distal ends that alternate with each other, which can reduce the amount of force required to anchor the surgical clip to tissue. In one embodiment, the bridge adjacent the proximal end of the surgical clip defines a third surface for seating the insertion tool that engages a surface on an insertion tool.

In one embodiment, the first leg of a surgical staple includes a first tab protruding toward the proximal end of the first leg, and the second leg of the surgical staple includes a second tab protruding toward the proximal end of the second leg, and the first and second tabs are sandwiched together. In one embodiment, the first and second tabs of the first and second legs, respectively, protrude outward in the opposite direction from each other. In another embodiment, the first and second tabs of the first and second legs, respectively, protrude inward toward each other.

In one embodiment, a surgical staple for anchoring prosthetic devices to tissue includes a first leg having a distal end, a proximal end, a first alignment guide extending between the distal and proximal ends of the first leg, and a first insertion tip at the distal end of the first leg. The surgical staple preferably includes a second leg having a distal end, a proximal end, a second alignment guide extending between the distal and proximal ends of the second leg, and a second insertion tip at the distal end of the second leg. The surgical clip preferably includes a bridge connecting the proximal ends of the first and second legs to form a closed end of the surgical clip.

In one embodiment, the first insertion tip has a proximal end with a first surface for seating the insertion tool and the second insertion tip has a proximal end with a second surface for seating the insertion tool. The first and second surfaces for seating the insertion tool may include convex surfaces facing the proximal ends of the first and second legs, concave surfaces facing the proximal ends of the first and second legs, openings facing the proximal ends of the first and second legs, Blind vias oriented toward the proximal ends of the first and second legs and / or openings that extend through the first and second insertion tips.

In one embodiment, the first and second alignment guides are selected from the group of alignment guides that includes grooves that extend between the distal and proximal ends of the legs and ribs that extend between the distal and proximal ends of the legs. The first and second alignment guides are practically aligned with the first and second surfaces to seat the insertion tool, respectively. In one embodiment, the first and second tool seating surfaces are preferably closer to the distal end of the surgical clip than to the proximal end of the surgical clip.

In one embodiment, an applicator instrument for supplying surgical staples includes a housing and an elongated stem extending from the housing; the elongated stem has a proximal end, a distal end, and a longitudinal axis extending between the distal and proximal ends. The applicator instrument preferably includes a trigger rod disposed within the elongated stem and being movable within a foreground between a retracted position and an extended position. The elongated stem preferably includes an impeller disposed within the elongated stem and which is movable within the background between a retracted position and an extended position. The applicator instrument preferably includes a stacking unit adjacent the distal end of the elongated stem that is adapted to align the surgical staples with a distal end of the trigger rod. The stacking unit is preferably kept below the second plane by means of the impeller when the impeller is in the extended position and the stacking unit is preferably adapted to move in at least partial alignment with the distal end of the the firing rod when the impeller moves forward or is in its retracted position.

The applicator instrument preferably includes a plurality of surgical staples disposed within the elongated stem and the driver is adapted to move the surgical clips one position toward the distal end of the elongated stem each time the driver is moved from the retracted position to the position extended. In one embodiment, the plurality of surgical staples preferably includes an initial surgical staple adjacent the distal end of the elongated stem and a series of follow-up surgical staples between the initial surgical staple and the proximal end of the elongated stem.

In one embodiment, the impeller includes a plurality of impeller protrusions, whereby each of the impeller protrusions is preferably adapted to engage one of the surgical clips to propel the surgical clips toward the distal end of the custom elongated stem that the impeller moves from the retracted position to the extended position. In one embodiment, the propeller protrusions protrude toward the distal end of the elongated stem. In one embodiment, the impeller can be moved to the extended position to bring the initial surgical clip into contact with the stacking unit.

In one embodiment, an elongated stem floor includes a plurality of anti-recoil projections, wherein the anti-recoil projections are adapted to prevent surgical clips on the elongated stem from moving toward the proximal end of the elongated stem. In one embodiment, the impeller anti-kick projections protrude toward the distal end of the elongated stem.

In one embodiment, the driver brings the initial surgical clip into contact with the stacking unit, and the stacking unit is adapted to lift the initial surgical clip to substantially align it with the distal end of the trigger rod as the driver returns to the retracted position.

In one embodiment, the elongated stem includes at least one guide surface adapted to engage and / or contact the trigger rod to guide distal and proximal movement of the trigger rod. In one embodiment, the at least one guide surface includes a pair of opposing guide tabs adapted to join the opposite sides of the trigger rod to guide distal and proximal movement of the trigger rod.

In one embodiment, the distal end of the trigger rod includes an insertion tool, such as an insertion fork, having a first tooth with a distal end adapted to engage the first surface to seat the insertion tool, and a second tooth having a distal end adapted to engage the second surface to seat the insertion tool. In one embodiment, the surgical staple bridge has a proximal face defining a third surface to seat the insertion tool, and the insertion tool induces a distal surface that extends between the proximal ends of the first and second teeth adapted to engage the third surface to seat the insertion tool.

In one embodiment, an applicator instrument for supplying surgical staples induces a housing, an elongated stem extending from the housing; the elongated stem includes a proximal end and a distal end far therefrom, and a plurality of surgical clips arranged within the elongated stem to be dispensed from the distal end of the elongated stem. The applicator instrument preferably induces an impeller disposed within the elongated stem that moves between the proximal and distal ends of the elongated stem; the impeller is adapted to change the surgical clips a position closer to the distal end of the elongated stem each time the impeller is moved distally. The applicator instrument preferably includes a trigger rod disposed within the elongated stem and covering the impeller; The firing rod can be moved between the proximal and distal ends of the elongated stem. The applicator instrument preferably includes a stacking unit adjacent the distal end of the elongated stem adapted to receive the main surgical clip from the impeller as the impeller moves distally and to change the initial surgical clip received in alignment substantial with a distal end of the trigger rod when the impeller is moved proximally.

In one embodiment, the distal end of the trigger rod is adapted to move distally at a first speed ratio to engage the initial surgical clip, and then move distally at a second speed ratio that is faster than the first speed ratio to deliver the initial surgical clip from the distal end of the elongated stem.

In one embodiment, the first leg of the surgical clip includes a first alignment guide extending between the proximal end of the first leg and the first surface to seat the insertion tool, and the second leg of the surgical clip includes a second alignment guide extending between the proximal end of the second leg and the second surface to seat the insertion tool. The first alignment guide of the first leg is preferably substantially aligned with the first surface to seat the insertion tool, and the second alignment guide on the second leg is preferably substantially aligned with the second surface to seat the insertion tool. insertion tool. In one embodiment, the first alignment guide includes a first slot that extends between the distal and proximal ends of the first leg, and the second alignment guide includes a second slot that extends between the distal and proximal ends of the second leg. , whereby the first and second teeth at the distal end of the trigger rod have opposite internal surfaces with opposite ribs adapted to engage the first and second grooves of the first and second legs, respectively, to engage the surgical clip with the insertion tool.

In one embodiment, a method of supplying the surgical clip includes providing an applicator instrument having a housing and an elongated stem extending from the housing; the elongated stem includes a proximal end and a distal end far therefrom and provides surgical clips on the elongated stem for dispensing one at a time from the distal end of the elongated stem. The method preferably includes propelling the surgical clips within a close-up toward the distal end of the elongated stem. After the main surgical staple is driven to a site adjacent to the distal end of the elongated stem, the initial surgical staple is preferably changed from the foreground to a second plane where the initial surgical staple is substantially aligned with a distal end of a firing rod. The trigger rod is then preferably moved distally to engage the initial surgical clip with the trigger rod and deliver the initial surgical clip from the distal end of the elongated stem.

In one embodiment, the method includes loading the surgical staples onto the elongated stem. In one modality, The step of moving the firing rod distally includes a first stage of distal movement during which the firing rod moves distally at a first speed ratio to engage the initial surgical clip and a second stage of distal movement that follows the first stage of distal movement during which the firing rod is moved distally at a second speed ratio to deliver the initial surgical clip from the distal end of the elongated stem, where the second speed ratio is greater than the first speed ratio.

In one embodiment, after the advance stage, and while limiting the firing rod to move to the distal end of the elongated rod, energy is stored in the firing system. The trigger rod can then be left free or released so that it can move in the distal direction and the stored energy can be transferred to the trigger rod by driving the trigger rod distally at the second speed that is greater than the first speed to deliver the first surgical clip from the distal end of the elongated stem.

In one embodiment, the trigger system includes an energy storage element, such as a compressible trigger spring attached to the trigger rod, and an actuator attached to the trigger spring to selectively compress the trigger spring to store energy in the firing system.

In one embodiment, a method of attaching a prosthesis to tissue includes providing an applicator instrument for supplying surgical staples having a housing, an elongated stem extending from the housing; the elongated stem has a proximal end attached to the housing and a remote distal end, and a trigger system for supplying surgical staples from the distal end of the elongated stem. The firing system preferably includes a firing rod disposed on the elongated stem; The firing system has a firing cycle with a first stage to propel the firing rod toward the distal end of the elongated stem at a first speed ratio and a second stage to propel the firing rod toward the distal end of the elongated stem to a second speed ratio that is greater than the first speed ratio. The method preferably includes placing a prosthesis, such as a surgical mesh, on a tissue and actuating the applicator instrument to deliver at least one of the surgical clips from the distal end of the elongated stem to fix the prosthesis to the tissue. In one embodiment, a wide variety of surgical staples can be supplied to secure the prosthesis to tissue.

In one embodiment, a trigger system for an applicator instrument adapted to supply surgical staples includes a housing, an elongated stem extending from the housing, a trigger rod disposed within the elongated stem, the trigger rod release latch can be engaged with the firing rod to prevent distal movement of the firing rod during at least one stage of a firing cycle, a housing mounted trigger and a trigger spring having a first end connected to the trigger rod and a second end adapted to be sequentially engaged or disengaged from the trigger during the trigger cycle. In one embodiment, the trigger cycle preferably includes an initial stage in which the trigger opens and disengages from the trigger spring, and the trigger spring is at least partially compressed, and a steering stage during which The firing rod is released and disengaged from the firing rod to allow distal movement of the firing rod. The trigger can preferably be compressed a first distance to engage the trigger with the trigger spring to move the at least one partially compressed trigger spring distally, which in turn moves the trigger rod distally to a first speed ratio proportional to the movement of the trigger. In one embodiment, an energy storage element, such as a pneumatic or hydraulic device, can be used in place of or in combination with the trigger spring.

In one embodiment, the firing cycle includes, after the steering stage, an energy storage stage in which the firing rod release latch engages the firing rod to prevent distal movement of the firing rod , and the trigger moves, in addition, to a second distance to further compress and store energy in the trigger spring. The firing cycle preferably includes a firing stage where the firing rod release latch disengages from the firing rod to release the firing rod to move freely to the distal end of the elongated stem and the firing spring transfers the energy stored there to the trigger rod to rapidly propel the trigger rod toward the distal end of the elongated stem at a second speed ratio that is greater than the first speed ratio and that the trigger movement.

In one embodiment, the firing cycle includes a decoupling stage during which the trigger can further be compressed by a third distance to disengage the trigger from the firing spring so that the firing rod is free to move toward the proximal end of the elongated stem.

In one embodiment, the firing system includes an impeller disposed within the elongated stem and moving proximally and distally along the elongated stem. The firing cycle, after the firing step, preferably includes a step of advancing the surgical clip during which the trigger can be further compressed a fourth distance to move the impeller toward the distal end of the elongated stem to move the surgical staples towards the distal end of the elongated stem.

In one embodiment, the firing cycle after the surgical staple advance stage preferably includes a retraction stage during which the trigger moves from a compressed position to the open position of the initial stage to move the impeller in a proximal direction.

In one embodiment, the trigger system preferably includes a spring compartment arranged within the housing and engageable with a proximal end of the trigger spring. The spring compartment is preferably adapted to move proximally and distally along the longitudinal axes defined by the elongated stem. In one embodiment, during the energy storage step, the trigger engages with the spring compartment to move the spring compartment distally, which, in turn, further compresses the trigger spring.

In one embodiment, the trigger system includes a primary latch coupled with the trigger. The primary latch is preferably adapted to engage the trigger with the spring compartment during the steering, energy storage, and firing stages, and disengage the trigger from the spring compartment during the decoupling, clip advance stages. surgical and retraction. In one embodiment, at the start of the firing step, the spring compartment contacts the released firing rod to disengage the released firing rod from the firing rod so that the firing rod can move distally.

In one embodiment, a firing system for a surgical stapler instrument includes a housing and an elongated stem extending from the housing. The firing system preferably includes a firing rod disposed within the elongated stem and moving proximally and distally along a longitudinal axis, a firing spring compartment disposed within the housing that is adapted to move in proximal and distal direction along the longitudinal axis, and a trigger spring having a distal end connected to the trigger rod and a proximal end engaging with the trigger spring compartment. The trigger system preferably includes a trigger mounted on the housing to drive the trigger system, wherein the trigger includes a primary latch to sequentially engage and disengage the trigger from the trigger spring compartment during a trigger cycle.

In one embodiment, the trigger cycle preferably includes an initial stage in which the trigger is open, the trigger is decoupled from the trigger spring compartment, and the trigger spring is at least partially compressed. The trigger system preferably includes a steering stage in which the trigger rod is free to move distally and the trigger can be compressed a first distance to engage the trigger with the trigger spring compartment to move the spring firing at least partially compressed distally, which in turn moves the trigger rod distally to the first speed ratio that is proportional to the trigger motion. In one embodiment, the compression level of the trigger spring is maintained unchanged during the steering stage. In one embodiment, the trigger spring can be compressed during the steering stage.

In one embodiment, after the steering stage, the trigger cycle includes an energy storage stage, in which the trigger can further compress a second distance to further compress and / or store energy in the spring firing, while the released firing rod engages the firing rod to prevent distal movement of the firing rod.

The firing cycle, after the energy storage step, preferably includes a firing stage in which the released firing rod is disengaged from the firing rod so that the firing rod is free to move towards the distal end of the elongated stem and the firing spring transfers the energy stored there to the firing rod to rapidly propel the firing rod toward the distal end of the elongated stem at a second speed ratio greater than the first speed ratio.

The firing cycle, after the firing step, preferably includes a decoupling stage during which the trigger can be further compressed by a third distance to decouple the trigger from the firing spring and the firing rod so that said firing rod can be moved proximally.

In one embodiment, the firing system includes an impeller disposed within the elongated stem. The impeller is preferably movable between the proximal and distal ends of the elongated shaft to move the surgical staples toward the distal end of the elongated shaft. The firing cycle, after the firing step, may include a surgical clamp advance stage during which the trigger can be further compressed a fourth distance to move the impeller toward the distal end of the elongated stem which, at in turn, moves the surgical staples toward the distal end of the elongated stem.

In one embodiment, the firing system preferably includes a spring compartment disposed within the housing. The spring compartment is preferably adapted to move proximally and distally along the longitudinal axis. The spring compartment preferably engages the trigger spring, and during the energy storage step the trigger engages with the spring compartment to move the spring compartment distally which, in turn, compresses the trigger spring . The trigger system may further include a primary safety coupled with the trigger. The primary latch is preferably adapted to engage the trigger with the spring compartment during the steering, energy storage, and firing stages, and disengage the trigger from the spring compartment during the decoupling, clip advance stages. surgical and retraction.

In one embodiment, a method of supplying surgical staples from an applicator instrument includes providing a housing, an elongated stem extending from the housing, a firing rod disposed within the proximal and distally movable elongated stem for supplying surgical staples from the distal end. of the elongated stem, a trigger to operate the applicator instrument and an energy storage element arranged between the trigger and the trigger rod. The method preferably includes compressing the trigger to direct the trigger rod toward the distal end of the elongated stem at a first speed ratio and, after directing the trigger rod, preventing the trigger rod from moving distally while compressing, in addition, the trigger for energy storage in the energy storage element. The method preferably includes releasing the trigger rod for distal movement and transferring the energy stored in the energy storage element to the trigger rod to move the trigger rod to the distal end of the elongated stem at a second ratio of speed that is greater than the first speed ratio. In one embodiment, during the steering step, the trigger rod is moved distally at a first speed ratio proportional to the trigger movement.

In one embodiment, the energy storage element is a trigger spring disposed between the trigger and the trigger rod. In one embodiment, the trigger spring is compressed at least partially before directing the trigger rod toward the distal end of the elongated stem, and the trigger spring has a degree of compression that does not change during the steering step. As mentioned in the present description, the energy storage element may further include a pneumatic device, a hydraulic device, a compressed gas device, or combinations thereof.

In one embodiment, the method includes providing a plurality of surgical staples within the elongated stem and providing an impeller disposed within the elongated stem. The impeller is preferably attached to the trigger and is adapted to move toward the distal end of the elongated stem when the trigger is compressed and moves toward the proximal end of the elongated stem when the trigger is open. The method preferably includes compressing the trigger to move the impeller toward the distal end of the elongated stem, whereby the impeller moving distally displaces each of the surgical clips a position closer to the distal end of the elongated stem. In one mode, the trigger may not return to the open position until it has been fully depressed to the closed position.

The applicator instrument can have various lengths and diameters. Short lengths may be appropriate for open surgical procedures. In one embodiment, the stem diameter of the applicator instrument is preferably between about 3-10 mm and, more preferably, between about 3-5 mm. In one embodiment, the applicator instrument includes more than one surgical staple and can be loaded, precisely, with a plurality of staples such as 10, 25,100, or more surgical staples. In one embodiment, the applicator instrument can be preloaded with 10 surgical staples for open procedures. In one embodiment, the applicator instrument can be preloaded with 30 surgical staples for standard laparoscopic procedures. In one embodiment, the surgical staples can be housed in cartridges for easy loading and / or refilling.

In certain embodiments, the applicator instrument may include a support suturing device as part of the handle or a device / handle that provides a skin adhesive, such as the tissue adhesive marketed under the trademark Dermabond ™, used to close wounds. of the trocar.

In one embodiment, a surgical staple preferably has a very small profile, can be semi-rigid, and fully reabsorbed. The resorbable nature of the surgical staple preferably reduces chronic pain due to permanent fixation. Additionally, the low profile of the surgical staple reduces viscera adhesions. As experts in the field know well, it is very common to observe adhesions caused by permanent tacks during reoperations.

In one embodiment, a surgical staple provides two fixation points with a connecting posterior span extending between the two fixation points to distribute the retention forces to the tissue over a larger area. The span between the two attachment points makes it possible to spread the tacks across the edge of a mesh, minimizing exposure of tissue to the ends of the mesh that could cause tissue irritation.

In one embodiment, an applicator instrument applies one or more surgical staples to the soft tissue. Surgical staples provide a fixation to the low-profile soft tissue of prosthetic materials in the human body. In one embodiment, the applicator instrument allows tension-free laparoscopic repair with the use of a mesh. In one modality, a prosthetic mesh is placed over an abdominal defect and attached to the tissue with surgical staples, either permanent or resorbable. In one embodiment, the surgical staples are made of relatively soft materials, such as plastic or absorbable polymers.

The present invention provides several benefits. In one embodiment, the male features of a surgical clip are coupled with the female features in an inserter device, which reduces the cost to mold the surgical clips. In one embodiment, the pins or teeth of an insertion device provide stiffness during insertion of the surgical staple and leave less mass absorbed in the tissues compared to stud systems and methods that do not use pins or insertion teeth to stiffen .

In one embodiment, the surgical staples have rounded proximal ends. Specifically, each surgical staple has a posterior bridge or span that connects to the proximal end of the rounded surgical staple and produces a very low profile after insertion into tissue. The low profile, small diameter design of the surgical staple results in a surgical staple that looks like a stitch once the surgical staple is implanted. Furthermore, the low profile preferably reduces the possibility of adhesion formation on the body.

In one embodiment, the surgical clips have insert holes or recesses that form in the proximal portion of each insertion tip of the surgical clips. The insert holes or recesses are preferably directly over the center of each insert tip. As a result, the insert holes or recesses are substantially aligned with the insert tip to prevent the tip from flexing and to direct the insert forces directly behind each of the penetrating insert tips.

In prior art staples having a single head, the single head may pass through the large pores of the prosthetic mesh. In one embodiment, the surgical staples of the present invention have a posterior span or connecting bridge between two insertion tips. The posterior stretch or connecting bridge makes the surgical clip more compatible for use with large pore surgical prosthetic meshes.

In one embodiment, the surgical staples have blind holes filled with inserters, probes, or metal teeth during application. Metal inserters preferably provide stiffness to the surgical clip during insertion, allowing the surgical clip itself to be made of a softer material, such as an absorbable polymer. In another embodiment, rigid inserters, probes, or teeth support the tips and / or legs of the surgical staple during anchoring in the tissue.

In one embodiment, the surgical staples have introducer channels that align with knockouts or surfaces to seat the tools. The introducer channels are axially open on at least one side, causing less material to be used to form the surgical staples, which provides a space for the growing tissue to maximize the clamping force.

In one embodiment, the surgical staples have angled tips that preferably reduce the necessary penetration force by staggering the peak forces encountered during insertion. In one embodiment, the surgical staples have stepped tabs that improve anchoring in the tissue by requiring greater forces to remove them.

In one embodiment, the surgical staples have tabs arranged out of plane of each other, which increases the force necessary to remove the surgical staples. In one embodiment, the surgical staples have insertion tips with perforations extending from one side to the other. The perforations are preferably adapted to receive one or more needles for needle assisted insertion.

In one embodiment, the surgical staples have one or more tabs with continuous hinge properties. Continuous hinges allow the tabs to easily collapse during insertion but increase outward during attempts to remove surgical staples.

In one embodiment, the pointed insertion tips of the surgical staples are cut or have defined cut points that allow the insertion tips to be cut during insertion to improve the ability of the surgical staples to penetrate difficult materials, such as dual mesh GORE®. Insert tips that have cut or carved compound angles can also be used to allow for stronger but shorter tip designs.

In one embodiment, the surgical clips may have tapered insert tips that create a perforation rather than a cut; therefore, they improve the holding force. Although the present invention is not limited by any particular theory of operation, it is believed that the tapered insertion tips produce only a single stress concentration point, whereby the section of the surgical clip that follows should expand the hole radially . This is believed to make it more difficult for the remainder of the surgical clip to pass through the hole, but may potentially increase retention forces by making the hole tighter.

In one embodiment, a surgical staple includes a pair of separate insertion points that have tabs facing inward. The inwardly facing tabs preferably protect the tabs from external forces and make surgical clips easier to supply multiplely without damaging the tabs. These modalities can have straight side walls and posterior sections that allow the surgical clips to remain properly aligned within the laparoscopic tube.

In one embodiment, the surgical staples can incorporate active agents, such as antimicrobial and non-stick materials. In one embodiment, the surgical clips can incorporate radio-opacity to allow the surgical clips to be visible on X-ray imaging equipment.

In one embodiment, grooves are formed on the outer side of each leg of the surgical staple, and an insert fork has a mating channel through each of the grooves. The ends of each fork tooth sit on recesses or seating surfaces that form at the insertion points of the surgical clip. This aforementioned design transfers the complexity of fabricating the recesses of the legs of the surgical staple to the teeth of the insertion tool. This property is especially important because the applicator instrument will preferably supply multiple surgical staples (as opposed to just an insertion fork).

In one embodiment, an insertion tool includes a bridge that extends between the proximal ends of the fork teeth. The shape of the bridge in the insertion tool can be practically conformed to the proximal face of the bridge at the proximal end of the surgical clip. In one embodiment, the insertion fork is designed such that the bridge element of the insertion fork contacts the proximal end of the surgical clips at or just before; the distal ends of each fork are seated or mated with the seating surfaces formed at the insertion points of the surgical clip. In one embodiment, the bridge of the insert fork may include a softer elastomeric material (depending on the durometer of the rest of the insert fork) to reduce the dimensional accuracy required to ensure contact of the bridge and distal ends of the fork with the surgical staple at about the same time. This configuration preferably allows the force behind the surgical clip to be directed so that it is distributed over a larger surface area of the surgical clip to reduce the pressure generated between the insertion tool and the surgical clip.

These and other preferred embodiments of the invention will be described in detail below.

BRIEF DESCRIPTION OF THE FIGURES

Figure 1A shows a perspective view of an applicator instrument for supplying surgical staples in accordance with an embodiment of the present invention.

Figure IB shows a left side view of the applicator instrument shown in Figure 1A.

Figure 1C shows a right side view of the applicator instrument shown in Figure 1A.

Figure 2 shows a sectional view of a proximal end of the applicator instrument shown in Figures 1A to 1C, in accordance with an embodiment of the present invention.

Figure 3A shows a diagrammatic perspective view of a distal end of the applicator instrument shown in Figures 1A to 1C, in accordance with an embodiment of the present invention.

Figure 3B shows a diagrammatic left side view of the distal end of the applicator instrument shown in Figure 3A.

Figures 4A to 4E show a stacked sheet unit for the applicator instrument shown in Figures 1A to 1C, in accordance with one embodiment of the present invention.

Figure 5A shows a perspective view of a distal end of an applicator instrument for supplying surgical staples, in accordance with an embodiment of the present invention.

Figure 5B shows a side view of the distal end of the applicator instrument shown in Figure 5A.

Figure 5C shows a top plan view of the distal end of the applicator instrument shown in Figures 5A and 5B.

Figure 6 shows a perspective view of a distant end! of an applicator instrument, in accordance with an embodiment of the present invention.

Figure 7A shows a distal end of an applicator instrument that includes an external tube, in accordance with an embodiment of the present invention.

Figure 7B shows the distal end of the applicator instrument of Figure 7A without the outer tube.

Figure 8A shows a perspective view of a surgical staple, in accordance with an embodiment of the present invention.

Figure 8B shows a front view of the surgical clip shown in Figure 8A.

Figure 8C shows a left side view of the surgical clip shown in Figure 8A including an insertion tip.

Figure 8C-1 shows an enlarged view of the insertion tip shown in Figure 8C.

Figure 8D shows a right side view of the surgical staple shown in Figure 8A.

Figure 8E shows a view of the distal end of the surgical staple shown in Figure 8A.

Figure 8F shows a view of the proximal end of the surgical staple shown in Figure 8A.

Figure 8G shows a cross sectional view of one of the legs of the surgical clip shown in Figure 8F.

Figure 9A shows a perspective view of an insertion fork aligned with a surgical clip, in accordance with an embodiment of the present invention.

Figure 9B shows a top plan view of the insertion fork and surgical clip shown in Figure 9A.

Figure 10A shows a distal end of an applicator instrument for supplying surgical staples, in accordance with an embodiment of the present invention.

Figure 10B shows a side view of the distal end of the applicator instrument shown in Figure 10A.

Figure 10C shows a top plan view of the distal end of the applicator instrument shown in Figures 10A and 10B.

Figures HA to 11N show a cross sectional view of a proximal end of an applicator instrument during the stages of a firing cycle, in accordance with an embodiment of the present invention.

Figures 11A-1 through 11N-1 show a sectional side view of a distal end of an applicator instrument during the stages of a firing cycle shown in Figures HA through 11N, respectively.

Figures 12A through 12E show a method of using an applicator instrument to deliver surgical staples to secure a prosthetic device to tissue, in accordance with an embodiment of the present invention.

Figure 13A shows a perspective view of a locking system for an applicator instrument, in accordance with an embodiment of the present invention.

Figure 13B shows a side view of the locking system shown in Figure 13A.

Figures 14A to 14E show a top plan view of the locking system of Figures 13A and 13B, in accordance with an embodiment of the present invention.

Figures 15A to 15E show other perspective views of the locking system shown in Figures 13A to 13B and 14A to 14E, in accordance with an embodiment of the present invention.

Figures 16A through 16B show a surgical staple, in accordance with an embodiment of the present invention.

Figures 17A-17C show a method of supplying a surgical staple with the use of an insertion tool, in accordance with an embodiment of the present invention.

Figures 18A to 18B show a surgical staple, in accordance with an embodiment of the present invention.

Figures 19A through 19C show a distal end of an insertion tool for implanting the surgical staple of Figures 18A through 18B, in accordance with one embodiment of the present invention.

Figures 20A to 20C show a method of implanting the surgical staple of Figures 18A to 18B with the use of the insertion tool of Figures 19A to 19C, in accordance with one embodiment of the present invention.

Figure 20B-1 shows an enlarged view of the surgical clip and the distal end of the insertion tool shown in Figure 20B.

Figures 21A to 21B show a surgical staple, in accordance with an embodiment of the present invention.

Figures 22A to 22C show an insertion tool for implanting the surgical staple of Figures 21A to 21B, in accordance with an embodiment of the present invention.

Figure 23 shows a perspective view of a surgical staple having tabs out of plane, in accordance with an embodiment of the present invention.

Figure 24 shows a surgical staple, in accordance with an embodiment of the present invention.

Figure 25A shows a perspective view of a surgical staple, in accordance with an embodiment of the present invention.

Figure 25B shows an insertion tool for applying the surgical staple of Figure 25A, in accordance with an embodiment of the present invention.

Figure 26 shows a front view of a surgical staple, in accordance with an embodiment of the present invention.

Figure 27 shows a distal end of an applicator instrument for supplying surgical staples, in accordance with an embodiment of the present invention.

Figures 28A and 28B show a method of using the applicator instrument shown in Figure 27 to deliver a surgical staple, in accordance with one embodiment.

Figure 29 shows a distal end of an applicator instrument for supplying surgical staples, in accordance with an embodiment of the present invention.

Figures 30A to 30D show a surgical staple having articulation joints, in accordance with an embodiment of the present invention.

Figures 31A to 31D show a surgical staple having articulation joints, in accordance with another embodiment of the present invention.

Figures 32A to 32D show a surgical staple having articulation joints, in accordance with yet another embodiment of the present invention.

Figure 33 shows a surgical staple having articulation joints, in accordance with another embodiment of the present invention.

Figure 34 shows a surgical staple having a tensioning element, in accordance with an embodiment of the present invention.

Figure 35 shows a surgical staple having a tensioning element, in accordance with another embodiment of the present invention.

DETAILED DESCRIPTION OF THE INVENTION

Referring to Figures 1A through 1C, in one embodiment, an applicator instrument 100 for supplying surgical staples has a proximal end 102 and a distal end 104. Applicator instrument 100 includes a housing 106 containing a firing system for applying the staples surgical Housing 106 has a left cover 108 and a right cover 110. The left and right covers 108, 110 have lower ends that form a handle 112. Applicator instrument 100 preferably includes a trigger 114 that can be squeezed to deliver surgical staples from distal end 104 of the instrument. In one embodiment, the applicator instrument 100 is capable of a plurality of surgical staples, whereby a single surgical staple is supplied from the distal end 104 of the applicator instrument each time trigger 114 is depressed. In one embodiment, the applicator instrument is capable of a plurality of surgical staples advanced to the distal end of outer tube 116 each time trigger 114 is depressed. The surgical clips preferably advance one position each time the trigger is depressed.

In one embodiment, applicator instrument 100 preferably includes an elongated outer stem or tube 116 having a proximal end 118 coupled with a distal end of housing 106 and a distal end 120 adapted to supply the surgical staples. The most distal end of the elongated outer tube 116 preferably has an end cap 122 secured thereto. The applicator instrument preferably has a longitudinal axis called AA that extends between the proximal and distal ends 102, 104 thereof. The outer tube 116 preferably extends over the longitudinal axis AA.

Referring to Figure 1A, in one embodiment, housing 106 may include an opening for lockout indicator 124 that provides visual access to the lockout indicator. In one embodiment, the applicator instrument initially supports a plurality of surgical staples that are supplied from the distal end 120 of the outer tube 116. The lock indicator preferably moves to a lock position that occurs after all surgical clips have been delivered. The opening of the lock indicator 124 can provide an indication of how many surgical clips have been supplied, how many surgical clips remain on the applicator instrument and / or when the blocking condition has been reached.

Referring to Figure 2, in one embodiment, housing 106 preferably contains a trigger system for supplying one or more surgical clips from the distal end of the instrument. As will be described in greater detail below, many of the firing system components move along the longitudinal axis AA, between the proximal and distal ends of the instrument. The components generally move toward the distal end 104 when the trigger 114 is pulled or pressed and in the opposite direction to move toward the proximal end when the trigger is opened.

In Figure 2, the left cover 108 (Fig. IA) of housing 106 has been removed to reveal at least some of the components of the firing system. In one embodiment, the trigger system includes trigger 114 having a trigger gear 126 coupled thereto. Trigger gear 126 preferably includes a trigger return projection 128 adapted to travel along a guide path for trigger 129. Trigger return projection 128 is preferably attached to an upper end of trigger return spring 130. In one embodiment, trigger return spring 130 is stretched when trigger 114 is pressed to store energy in the spring trigger return. When the trigger is free to return to the open position, the trigger return spring 130 preferably pulls the trigger return projection 128 toward the initial position shown in Figure 2. The firing system preferably includes a damping element of the trigger 132 coupled with the return projection of the trigger 128 for a damping movement of the trigger 114 as it approaches the ends of the guide path for the trigger 129. The damping element The trigger 132 may be made of a deformable material, such as a polymer or rubber.

Trigger gear 126 includes trigger gear teeth 134 adapted to engage a first group of teeth (not shown) that are located on a drive gear 136. Drive gear 136 includes a second group of teeth 138 adapted to engage with teeth 140 at the bottom of a bar 142. Drive gear 136 is driven by trigger gear 126. When trigger 114 is depressed, trigger gear 126 rotates drive gear 136 counterclockwise. When trigger 114 opens, trigger gear 126 rotates drive gear 136 clockwise.

In one embodiment, the firing system includes a bar 142 adapted to move distally and proximally on the longitudinal axis AA of the applicator instrument. In one embodiment, bar 142 is directly coupled to trigger 114 via trigger gear 126 and drive gear 136. When the trigger 114 is depressed to the closed trigger position, the trigger gear 126 and the drive gear 136 move the bar 142 distally (counterclockwise in Figure 2). As trigger 114 returns to the trigger open position, trigger gear 126 and drive gear 136 move bar 142 proximally (clockwise in Figure 2).

In one embodiment, the trigger system preferably includes a pawl 144 with a projection of pawl 145 that engages the teeth at the bottom of bar 142. The pawl is preferably coupled with a torsion spring. Ratchet 146. As will be described in greater detail below, during at least one stage of a trigger cycle, pawl 144 constrains bar 142 to change direction until trigger 114 is fully closed or fully open. In one embodiment, when trigger 114 is pulled, bar 142 is required to move distally beyond projection 145 on pawl 144 before the bar can change directions and move proximally.

The firing system preferably includes a main latch 150 projecting from a distal end of bar 142. Main latch 150 connects to bar 142 and moves simultaneously in distal and proximal directions with the bar. In one embodiment, main latch 150 is adapted to move on a main latch rail 152 formed in housing 106 to systemically engage and disengage bar 142 from another component of the firing system, as will be described in greater detail below. In one embodiment, as bar 142 moves distally, main latch 150 preferably moves over main latch rail 152. As the bar 142 moves proximally the main latch 150 preferably moves under the rail of the main latch 152.

The firing system preferably includes a computer 154 that is adapted to move distally and proximally on the longitudinal axis AA of the applicator instrument. Computer 154 includes a lower slot 156 in communication with a protrusion 158 extending from one side of bar 142, hereinafter referred to as bar protrusion 158. Bar protrusion 158 is adapted to slide into the slot lower 156 of computer 154. In one embodiment, when the protrusion of the bar 158 reaches a distal end 160 of the lower slot 156 of the computer, the projection of the bar 158 prompts the computer 154 to move towards the distal end of the applicator instrument 100. The computer 154 includes a top slot 162 coupled with a lock indicator system, as will be described in greater detail below.

In one embodiment, computer 154 is directly coupled to a driver 166 that is adapted to drive surgical staples toward the distal end of the applicator instrument. When computer 154 is moved in the distal direction, the impeller 166 is moved simultaneously with the computer to the distal end of the applicator instrument. When the computer is moved proximally, the impeller 166 moves simultaneously with the computer to the proximal end of the applicator instrument. In one embodiment, the impeller 166 is adapted to move the surgical clips toward the distal end of the applicator instrument so that the surgical clips can be delivered from the distal end of the instrument. In one embodiment, the surgical staples advance one position each time the impeller is moved proximally.

In one embodiment, the firing system preferably includes a spring compartment 170 that is selectively coupled with bar 142 by means of main latch 150. The spring compartment is preferably adapted to move distally and proximally thereto. along the longitudinal axis designated AA. In one embodiment, when the main latch 150 is coupled with the spring compartment, the bar and the spring compartment move, preferably, simultaneously with each other as a unit. When the main latch 150 is disengaged from the spring compartment 170, the bar 142 and the spring compartment move preferably independently of each other.

In one embodiment, the trigger system further preferably includes a trigger spring 172 positioned within spring compartment 170. Trigger spring 172, precompressed within the spring compartment, preferably has a distal end coupled to a trigger rod 174 and a proximal end that attaches to a proximal end wall 171 of the spring compartment. In one embodiment, the proximal end of firing rod 174 preferably has a cruciform junction 176 connected to the distal end of firing spring 172. One or more dampers of firing rod 178 may be connected to cruciform junction 176 to cushion the movement of the firing rod 174 when it reaches the distal and / or proximal ends of its travel.

In one embodiment, the firing system includes a firing spring release latch 180 that limits distal movement of the firing rod. During one stage of a firing cycle, the firing spring release latch limits movement in the distal direction of the firing rod while energy is stored in firing spring 172. During a later stage of the firing cycle, the firing spring release latch releases firing rod 174 to move distally. As will be described in greater detail below, in one embodiment, the trigger latch 180 is preferably attached to an outer surface of the spring compartment 170. The outer surface of the spring compartment preferably pushes the firing latch into a released position to release firing rod 174 for movement in the distal direction.

In one embodiment, the firing system preferably includes a firing rod return spring 184 that attaches to spring compartment 170 to return spring compartment 170, the proximal starting position shown in Figure 2. When spring compartment 170 is moved distally (counterclockwise), energy is stored in the return spring of trigger rod 184. The energy is then transferred to move the spring compartment proximally. At this stage, the trigger rod can be moved proximally with the spring compartment. The firing system further preferably includes one or more damping springs 186 which are connected to engage one or more components of the firing system to dampen the movement of the components within the range limits of the paths. The damper springs minimize, preferably, noise, vibration, violent movements, etc. during firing cycles.

Referring to Figure 3A, in one embodiment, a distal end 104 of applicator instrument 100 is adapted to deliver surgical staples 232. The outer tube (Fig. IA) shown in Figure 3A, which normally surrounds the components, is It has been removed to more clearly show the internal components. In the particular embodiment shown in Figure 3A, the internal components of the distal end 104 of the applicator instrument 100 have been enlarged to more clearly show the parts and operation of the applicator instrument.

Referring to Figure 3A, in one embodiment, the applicator instrument 100 includes a die cover 200 having one or more protrusions for the die cover springs 202 throughout its length. The die cover 200 preferably includes one or more cutouts of the die cover unit 204 in its side walls to facilitate the unit of the applied instrument. Die cover 200 preferably includes a pair of alignment guides 206 that are adapted to direct movement in the distal and proximal direction of the trigger rod, as will be described in greater detail below.

The applicator instrument further preferably includes a recoil die 208 which is assembled to the die cover 200. The recoil die 208 includes side walls having protrusions of unit 210 protruding therefrom. The protrusions of the unit 210 are adapted to align with the cutouts of the unit 204 in the die cover 200 to facilitate proper alignment and assembly of the die cover with the backstop die. The anti-reverse die 208 preferably includes anti-reverse projections 212 along its entire length. The anti-reverse projections project preferably toward the distal end of the applicator instrument and allow the surgical clips to move in one direction, specifically in the distal direction. The anti-reverse projections 212 preferably prevent the surgical clips from moving toward the proximal end of the applicator instrument.

Referring to Figure 3A, the anti-recoil die 208 preferably includes an opening in the mounting blade 214 that is located at a distal end of the anti-recoil die 208, and an opening 216 proximal to the opening in the mounting sheet 214 is preferably used to secure a stacked sheet unit to the anti-recoil die 208, as will be described in greater detail below.

The applicator instrument preferably includes the firing rod 174 having an insertion yoke 220 at a distal end thereof. Insertion fork 220 has a proximal end 222 attached to a distal end of the main section of the firing rod 174 and a distal end 224 adapted to engage the surgical staples. The distal end of the applicator instrument further preferably includes the stacked blade unit which includes a mounting blade holder 226 and a mounting blade 228. The proximal ends of the respective mounting blade holder 226 and the Mounts 228 are aligned with opening 216 of recoil die 208.

The applicator instrument further preferably includes the impeller 166, which is adapted to advance surgical staples toward the distal end of the instrument. The impeller preferably has impeller protrusions 230 adapted to engage the surgical clips to drive the surgical clips toward the distal end of the applicator instrument. In one embodiment, impeller 166 advances the surgical clip one position toward the distal end of the applicator instrument each time the trigger is depressed to the closed position.

Figure 3B shows an enlarged side view of the distal end 104 of the applicator instrument 100. The die cover 200 is adapted to assemble with the opposite anti-recoil die 208. The recesses of the unit 204 of the die cover 200 are preferably aligned. with cutouts in unit 210 in backstop die 208. The firing rod 174, including the insert fork 220, the impeller 166, the mounting sheet holder 226 and the mounting sheet spring 228 are preferably at least partially disposed between the die cover 200 and the anti-recoil die 208. After the components shown in Figure 3B have been assembled, the components are preferably arranged within the outer tube 116 shown in Figures IA to 1C. In one embodiment, the end cap 122 is preferably assembled with the most distal ends of the outer tube 116, the die cover 200, and the anti-recoil die 208. In one embodiment, the projections for the springs of the die cover 202 exert pressure preferably against the inner surface of the outer tube to minimize movement of the inner components within the outer tube.

Referring to Figure 3B, in one embodiment, the impeller 166 includes a series of projections of the impeller 230 protruding below the impeller. The projections of the impeller 230 preferably project towards the distal end of the impeller 166. The projections of the impeller 230 preferably engage the surgical clips 232 arranged within the outer tube to drive the surgical clips towards the distal end of the applicator instrument . In one embodiment, a plurality of surgical staples 232A-232D are provided, preferably, within the applicator instrument. Each time the trigger is squeezed, the projections on the impeller 230 drive surgical staples 232A-232D toward the distal end of the instrument to dispense them from the distal end of the instrument. When a follow-up surgical staple (for example, the staple called 232B) advances enough to become an initial surgical staple (for example, the final staple called 232A), it advances to make contact with mounting sheet 228, which is adapted to move the initial surgical staple 232A to align with the teeth of the distal end of insertion fork 220.

Referring to Figures 4A through 4E, in one embodiment, the applicator instrument includes the stacked sheet unit that is adjacent to the distal end of the recoil die.

208. Referring to FIG. 4A, in one embodiment, the anti-recoil die 208 includes the anti-recoil protrusions 212 projecting toward the distal end of the anti-recoil die 208. The anti-recoil die 208 includes the mounting sheet opening 214 which is preferably disposed between the anti-reverse end projection 212A and the distal end of the anti-reverse die 208. The anti-recoil die 208 further preferably includes the opening 216 proximal to the opening of the mounting sheet 214. The opening is preferably adapted to align with a proximal end of the mounting sheet holder 226 and the mounting sheet 228.

Referring to Figure 4A, as mentioned above, the stacked sheet unit preferably includes mounting sheet holder 226 and mounting sheet 228. The mounting sheet holder 226 has an opening 227 in a proximal end thereof, which is preferably aligned with opening 216 of anti-recoil die 208. Mounting blade 228 preferably includes a distal end having a protrusion of mounting blade 229 and a proximal end including an opening 231 that is adapted to align with opening 216 of the anti-recoil die and opening 227 in the holder of the mounting sheet. Mounting blade 228 also includes a backstop protrusion of mounting blade 233 protruding toward the distal end of mounting blade 228.

Figures 4B to 4E show how the mounting sheet holder 226 and mounting sheet 228 are assembled with the anti-recoil die 208. As shown in Figures 4B and 4C, in one embodiment, the mounting blade 228 is positioned on the mounting blade holder 226 and the proximal ends of the assembled components are passed through the opening in the mounting blade. Mount 214 so that openings 227, 231 are aligned with opening 216 of anti-recoil die 208 at the proximal ends of mounting blade holder 226 and mounting blade 228.

Referring to Figures 4D and 4E, the proximal ends of mounting blade 228 and mounting blade holder 226 lie below a lower surface of anti-recoil die 208 and are permanently connected to the lower surface of die backstop. The connection can be made through the use of a fastener, such as a screw, or other well-known connection methods, such as welding. As shown in Figures 4D and 4E, the distal ends of the mounting blade 228 and the mounting blade holder 226 extend through the opening in the mounting blade 214, and the protrusion of the mounting blade 229 protrudes normally above the recoil die 208.

Although the present invention is not limited by any particular theory of operation, it is believed that the stacked blade unit provides a spring-like device at the distal end of the recoil die to drive and / or move an initial surgical staple to align with the teeth in the distal end of the insertion fork. The stacked blade unit can be deflected downward by means of the distal ends of the driver and insertion fork when the components extend toward the distal end of the applicator instrument. When the insert fork and driver are retracted proximally to the stacked sheet unit, however, the stacked sheet unit is preferably directed upward to the position shown in Figures 4B to 4E. As the stacked sheet unit is directed upward, an initial surgical staple positioned on top of the stacked sheet unit aligns with the distal end of the insertion fork. In one embodiment, the mounting blade protrusion 229 and the backstop protrusion of the mounting blade 233 stabilize the initial surgical clip and hold the final surgical clip in position while advancing the insertion fork to secure the initial surgical clip.

Referring to Figures 5A through 5C, in one embodiment, the die cover 200 is assembled with the anti-recoil die 208. The die cover 200 includes at least one assembly slot 204 that is aligned with at least one protrusion of the anti-recoil die unit 210 208 to ensure proper alignment of the dies 200, 208 with each other. The more distal ends of the die cover 200 and the anti-recoil die 208 are held together, preferably, by the end cap 122. In one embodiment, the die cover has projections for die cover springs 202 that preferably engage an inner surface of the outer tube (not shown) to improve the stability of the applicator instrument and prevent the cover of the die and anti-recoil die move relative to outer tube. In one embodiment, the end cap 122 and the more distal ends of the die cover and the recoil die have one or more tongue and groove structures for assembling the end cap 122 with the cover and the recoil die 200, 208.

Referring to Figure 6, in one embodiment, the most distal ends of die cover 200 and anti-recoil die 208 are held together by end cap 122. In one embodiment, die cover 200 may include a pair of flanges. guide 206 preferably forming the side walls of insertion fork 220 when the trigger rod is moved distally and proximally. In one embodiment, guide tabs 206 preferably guide the distal and proximal movement of insert fork 220 to ensure proper alignment of the teeth of the insert fork with the final surgical staple 232A. Applicator instrument 100 preferably includes the stacked sheet unit that includes mounting sheet holder 226 and mounting sheet 228. As previously discussed, the proximal ends of the mounting blade holder 226 and mounting blade 228 are preferably coupled with the anti-recoil die 208. In one embodiment, the impeller 166 is preferably positioned between the blade unit stacked and insert fork 220. The impeller 166 includes projections of the impeller 230 that engage the surgical clips 232 to propel the surgical clips to the distal end 104 of the applicator instrument 100. Each time the impeller is moved distally, the propeller projections are preferably advanced , the surgical clips one position toward the distal end of the applicator instrument.

Referring to Figure 7A, in one embodiment, outer tube 116 is positioned around die cover 200 and anti-recoil die 208. In Figure 7A, outer tube 116 is transparent such that the die cover and the anti-recoil die are visible. End cap 122 is secured on the distal end of outer tube 116 and includes unit flanges disposed between outer tube 116 and the die cover and anti-recoil die. End cap 122 is preferably attached to die cover 200 and anti-recoil die 208 to provide stability at the distal end of applicator instrument 100. In one embodiment, end cap 122 preferably includes grooves 242 formed in one end face. distal to this. Slits 242 are adapted to engage surfaces (eg, mesh) so as to prevent the distal end of the applicator instrument from slipping or moving relative to opposite surfaces. Grooves 242 can further be used to align the distal end of the applicator instrument as a prosthetic device, such as a prosthetic mesh. In one embodiment, the slits can be used to align the distal end of the applicator instrument with one or more strands in a prosthetic device.

FIG. 7B shows the distal end of the applicator instrument of FIG. 7A without outer tube 240. End cap 122 includes a flange at the apex of unit 244 that attaches to die cover 200 and a flange at the top. bottom of unit 246 that attaches to recoil die 208. The tabs on the cusp and on the bottom of the unit 244, 246 preferably hold together the most distal ends of the die cover and the anti-recoil die to stabilize the distal end of the applicator instrument. The inner face of end cap 122 preferably includes a pair of side projections on unit 248A, 248B that are disposed between the die cover and the anti-recoil die. The lateral protrusions of the 248A, 248B unit can also improve the stability of the distal end of the applicator instrument.

Referring to Figures 8A through 8F, in one embodiment the applicator instrument dispenses surgical staples from a distal end thereof. Referring to Figures 8A and 8B, in one embodiment a surgical staple 232 preferably includes a distal end 250 and a proximal end 252. Surgical staple 232 preferably includes a first portion 254 having a first tip 256 at a distal end of a first leg and a second leg 258 having a second tip 260 at a distal end of the second leg. In one embodiment, the cross-sectional dimension of each first and second leg decreases as it moves from the proximal ends to the distal ends of the legs. Surgical clip 232 preferably includes a bridge 262 adjacent proximal end 252 of surgical clip connecting the proximal ends of the first and second legs 254, 258. In one embodiment the bridge can be positioned between the proximal and distal ends of the surgical staple as long as the first and second legs are interconnected. Surgical clip 232 preferably includes at least a first tab 264 protruding rearwardly from first tip 256 and at least a second tab 266 protruding rearwardly from second tip 260. Although only one tab is shown at each Leg, other surgical staples may have multiple tabs on each leg or tip. The first and second tips 256, 260 may be conical in shape. The respective tips may have sharp edges or they may be more obtuse.

In one embodiment the first and second tips 256, 260 have distal biased drill tips or insert tips that are biased with respect to the longitudinal axes of the first and second legs respectively 254, 258. In one embodiment, the distal drill tips they are biased outward relative to the longitudinal axes of the first and second legs. In one embodiment, the distance between the tips is greater than the distance between the legs to increase the probability that the fibers of a prosthetic device will be caught between the legs. In one embodiment, the first and second tips 256, 260 have blunt distal drill tips. Blunt tips allow the surgical stapler to penetrate tissue while minimizing unwanted penetration into an operator's hand.

Referring to Figure 8B, in one embodiment, bridge 262 preferably includes a concave inner surface 268 facing the distal end 250 of surgical stapler 232 and a convex outer surface 270 facing proximal end 252 of surgical stapler . The first leg 254 has an outer wall that has a first groove 272 that extends along a longitudinal axis At of the first leg. Second leg 258 includes an outer wall having a second groove 274 that extends along longitudinal axis A2 of the second leg. In one embodiment, the distance Di between the drill points at the distal ends of the first and second points 256, 260 is preferably greater than the distance D2 between the opposite surfaces of the first and second legs 254, 256. The greater relative distance between the distal drill tips of the first and second tips 256, 260 preferably ensures that the surgical stapler will hold strands of a porous prosthetic device, such I pull the strands of a surgical mesh. In one embodiment, the outwardly biased distal drill tips provide an increased ability to hold surgical mesh fibers, where the mesh fibers are separated from one another without the need to increase the distance between each leg.

Referring to Figure 8C, in one embodiment, the first leg 254 has a first slot 272 that extends along the longitudinal axis Ai of the first leg. When viewed from the side shown in Figure 8C, the first slot 272 preferably substantially aligns with a point distal of the first drill tip 256.

Figure 8C-1 shows an enlarged view of the first drill or insertion tip 256 that includes a blunt drill point 257. In one embodiment, the blunt drill point 257 allows the distal end of the surgical clip to penetrate tissue into the while minimizing unwanted penetration into an operator's hand.

Referring to Figure 8D, in one embodiment, the second leg 25 8 has the second slot 274 that extends along the longitudinal axis A2 of the second leg 258. When viewed from the side shown in Figure 8D, the second groove 274 is aligned, substantially with a distal point of the second tip 260.

Referring to Figure 8E, in one embodiment, the first and second piercing tips 256, 260 are preferably biased outwardly from a center of the surgical staple 232. In one embodiment, the first and second piercing tips 256, 260 they are preferably asymmetric and are configured to extend outward from the center of surgical clip 232.

Referring to Figure 8F, in one embodiment, the rear face of a first insertion tip 256 includes a first bearing surface 280 adapted to receive a distal end of a first tooth of an insertion fork. The rear face of second tip 260 preferably includes a second bearing surface 282 adapted to receive a distal end of a second tooth of the insert fork. In one embodiment, the convex bearing surfaces 280, 282 are preferably substantially aligned with the distal drill bits of the first and second drill bits 256, 260. The distal ends of the insertion fork teeth may have surfaces accommodating support surfaces 280, 282.

Referring to Figure 8G, in one embodiment, the first leg 254 has an inner face that is rounded and an outer face that is square. Although the present invention is not limited by any particular theory of operation, it is believed that such a structure preferably increases the strength of the surgical clip with increasing sectional modulus. Providing legs having a cross section with a rounded inner surface and a square outer surface further preferably increases the force required to remove the surgical staple from the tissue.

In one embodiment, the surgical clip can be made of absorbable and / or non-absorbable materials. Preferred absorptive materials include PDS, PDS / lactide-glycolide combinations, PLA, etc. In one embodiment, each surgical staple is made to fit within a 5mm OD tube (typically, the size of a trocar cannula). The surgical staple is manufactured by molding; however, with minor modifications, other processes such as casting, die-cutting, and turning can be used. In one embodiment, the surgical staples can be extruded into a general configuration and subsequently formed.

Referring to Figures 9A and 9B, in one embodiment, surgical clip 232 is aligned with insertion fork 220 at the distal end of the trigger rod to be dispensed from the distal end of the applicator instrument. Insertion fork 220 includes a proximal end 222 adapted to connect with a distal end of a main section of a firing rod (not shown) and a distal end 224 adapted to engage one or more surfaces of surgical staple 232. In one embodiment, distal end 224 of insertion fork 220 includes a first tooth 290 having a first internal rib 292 formed therein and a second tooth 294 having a second internal rib 296 formed therein. In one embodiment, the internal ribs 292, 296 preferably oppose each other and extend along axes that are parallel to the longitudinal axis AA of the applicator instrument. During operation, the opposed internal ribs 292, 296 of the first and second teeth 290, 294 are preferably adapted to slide over the grooves 272, 274 of the first and second legs 254, 258 of the surgical clip. The engagement of the internal ribs 292, 296 with the grooves 272, 274 preferably aligns the element of the surgical clip 232 with the distal end 224 of the insertion fork 220 and stabilizes the surgical clip during implantation into the tissue. In one embodiment, the most distal tips of the first and second teeth 290, 294 are advanced until they engage with the convex bearing surfaces 280, 282 that are provided on the distal surfaces of the first and second tips 256, 260.

Although the present invention is not limited by any particular theory of operation, it is believed that providing an insertion fork with grooved teeth that engage the rods of the external surfaces of the legs of a surgical staple will improve stability and control of the surgical stapler by dispensing the surgical staple from the distal end of the applicator instrument. Furthermore, the insertion force is applied near the distal end of the surgical clip and not only on the proximal end of the surgical clip as in the case of prior art systems. This feature (i.e. applying insertion force on the surgical clip near the distal end of the clip) could allow the use of smaller and / or lower profile surgical clips.

Referring to Figure 10A, in one embodiment, the stacked blade unit includes a mounting blade holder 226 and a mounting blade 228 adapted to lift an initial surgical staple 232A to align with the teeth of the distal end 224 of the insertion fork 220. Mounting sheet 228 preferably includes a protrusion of mounting sheet 229 that can engage the inner surface of bridge 262 of surgical clip 232. The legs of the legs of the surgical clip are preferably aligned with the opposite internal ribs 292, 296 on the opposite teeth 290, 294 of the insertion fork 220.

Referring to Figure 10B, in one embodiment, mounting sheet 228 aligns rods 272, 274 of surgical staple 232 with internal ribs of teeth 290,

294 of insertion fork 220. The protrusion of mounting sheet 229 is preferably attached to bridge 262 of surgical clip 232 to stabilize surgical clip 232 while teeth 290, 294 slide on rods 272, 274.

Figure 10C shows a top plan view of the applicator instrument with the internal rib 292 of the first tooth 290 aligned with the first rod 272 of the first leg 254 of the surgical clip 232 and the internal rib 296 of the second tooth 294 aligned with the second rod 274 of the second leg 258 of the surgical staple. When the surgical staple is held still by mounting blade 228, the firing rod, including insertion fork 220, is advanced toward the surgical staple until the most distal ends of teeth 290, 294 engage the surfaces Support convex located behind the first and second points 256, 260. After teeth 290, 294 engage with convex bearing surfaces, insert fork 220 is ready to advance further toward the distal end of the applicator instrument to deliver surgical staple 232 from the applicator instrument.

Figures HA to UN show the triggering system of the applicator instrument during various stages of a triggering cycle. Figures 11A-1 to 11N-1 show the distal end of the applicator instrument during the same steps as shown in respective Figures HA to UN. For example, Figure HA shows the trigger system at the start of a trigger cycle with trigger 114 fully open and trigger rod 174 fully retracted. Figure 11A-1 shows the distal end of the applicator instrument at the same stage as shown in Figure HA. Figures 11B to 11N and Figures 11B-1 to 11N-1 follow the same pattern.

Referring to Figure 11A, in one embodiment, in a first stage of a firing cycle, trigger 114 is fully open and the projection of trigger gear 128 is at the lower end of firing guide 129. Bar 142, Computer 154, impeller 166, spring compartment 170, and trigger rod 174 are fully retracted toward the proximal end of the applicator instrument. In the first stage of the trigger cycle shown in Figure 11A, the main latch 150 is in a neutral position and is decoupled from the spring compartment 170. The trigger spring 172 is positioned between a proximal end of the spring compartment 170 and the cruciform coupling 176 of the proximal end of the firing rod 174. The trigger spring 172 extending between the spring compartment 170 and the trigger rod 174 is preferably precompressed so that there is an initial distal (counterclockwise) force on the trigger rod 174. The trigger rod 174 and impeller 166 project from a distal end of housing 106 and extend toward a distal end of applicator instrument 100.

Figure 11A-1 shows distal end 104 of applicator instrument 100 in the first stage of the firing cycle shown in Figure 11A. The outer tube, die cover, and anti-recoil die have been removed from the illustration to more clearly show the other internal components located at the distal end of the applicator instrument. Referring to Figure HA-I, mounting sheet holder 226 and mounting sheet 228 preferably support the initial surgical clip 232A so that rods 272, 274 of the outer walls of the surgical clip are aligned with the internal ribs formed at moments 290, 294 at the distal end 224 of insertion fork 220. The protrusion of the mounting blade 129 preferably stabilizes the initial surgical staple 232A from further distal movements. Follow-up surgical staples 232B, 232C, 232D are positioned behind the initial surgical staple 232A. Although only other surgical staples 232A-232D are shown in Figure 11A-1, the applicator instrument may carry additional surgical staples, for example 10, 25, 100, or more surgical staples. Impeller 166 includes projections of impeller 230 that are adapted to push respective surgical staples 232B-232D toward the stacked blade unit at distal end 104 of applicator instrument 100. Each time impeller 166 is moved to the left, the staples Surgical steps advance one position toward distal end 104 of applicator instrument 100.

Figure 11B shows a later stage of the firing cycle during which the teeth on the distal end of the insertion fork are directed to engage the leg grooves of the initial surgical clip. During this stage of the firing cycle, trigger 114 is partially squeezed to handle 112 to move trigger gear 126 and projection of trigger gear 128 toward the upper end of trigger guide 129. When trigger 114 is pulled, trigger return spring 130 connected to the projection of trigger gear 128 is stretched to store potential energy in the spring. When the trigger gear 126 is moved up, counterclockwise, the teeth of the trigger gear 126 rotate the drive gear 136 counterclockwise. The second set of gear teeth 138 on the periphery of drive gear 136 mates with teeth 140 which extend along the underside of bar 142 to move bar 142 toward the distal end of the applicator instrument (toward the left). As bar 142 moves toward the distal end of the applicator instrument, the main latch 150 slides on the top surface of the main latch rail 152 to engage the bar with the spring compartment. Because the trigger spring 172 is pre-compressed within the spring compartment, the trigger rod is moved in the distal direction when the bar, the spring compartment and the trigger rod are moved in the distal direction as a unit. At this stage, the trigger rod moves distally at a speed that is proportional to the trigger movement.

Referring to Figure 11B, bar 142 is adapted to slide within housing 106 in distal and proximal directions along the longitudinal axis of the designated applicator instrument AA. As the bar 142 moves distally, the projection on the bar 158 slides in a distal direction toward the distal end 160 of the lower slot 156 of the computer 154. As will be described in greater detail below, when the shoulder of the bar 158 is spliced with the distal end 160 of the lower slot 156 of the computer 154, the shoulder of the bar 158 will drive the computer 154 to move in the distal direction.

Figure 11B-1 shows the distal end 104 of the applicator instrument 100 during the firing cycle stage shown in Figure 11B. The 290,294 at the distal end 224 of the insertion fork 220 are directed to engage the legs of the initial surgical staple 232A. Insertion fork 220 preferably moves distally at a speed that is proportional to the speed at which the trigger is depressed. The protrusion of the mounting sheet 229 and the mounting sheet 228 preferably stabilize the initial surgical clip 232A while the fork teeth 290, 294 are directed to engage with the grooves of the initial surgical clip. The protrusion of mounting sheet 229 can be attached to the inner surface of the outer tube to provide stability.

Figure 11C shows the firing system after the insertion fork has been directed toward the legs of the surgical clip. In Figure 11C, the distal end of the trigger system is on the right and the proximal end of the trigger system is on the left. About the same time or after the insertion fork has been directed distally to engage the initial surgical clip, a trigger spring latch 180 engages with the cruciform end 176 of the trigger rod 174. When engaged, the latch of the firing spring 180 prevents further distal movement of the firing rod 174. Up to this point in time, the trigger rod has moved as a unit with spring compartment 170, due to preload on the trigger spring within the spring compartment. Once the trigger spring latch 180 engages the cruciform end 176, the trigger rod cannot continue to move in the distal direction. As a user continues to press the trigger 114, the trigger rod 174 can no longer move distally and the trigger spring compresses.

Figure 11C-1 shows the distal end 104 of the applicator instrument 100 during the step shown in Figure 11C. After the distal end of the insertion fork 220 has been advanced against the initial surgical clip 232A, the trigger spring lock 180 prevents further movements in the distal direction of the trigger rod 174. Therefore, after directing the distal end of the insertion fork into contact with the initial surgical clip, and until the applicator instrument triggers the surgical clip from the distal end, the trigger rod has no further distal movement when The trigger is continued to be pulled into the fully closed position to store potential energy in the trigger spring.

Figure 11D shows a sectional view of a portion of the firing system during the same stage of the firing cycle as shown in Figure 11C. The firing system includes firing rod 174, cruciform structure 176 at the proximal end of firing rod 174, firing spring 172, and spring compartment 170 containing firing spring 172. In Figure 11D the distal end of the applicator instrument is to the left and the proximal end of the applicator instrument is to the right. As shown in Figure 11D, when the trigger is pulled the spring compartment 172 is propelled toward the distal end of the applicator instrument by the main latch (not shown). The distal movement of the spring compartment 170 compresses the trigger spring 172 between the cruciform structure 176 at the proximal end of the trigger rod 174 and the proximal end of the spring compartment 170. As mentioned earlier, during this stage, the Firing rod 174 can no longer be moved distally by limiting the safety of firing spring 180 that is attached to cruciform structure 176 of firing rod 174. Figure 11D-1 shows the distal end 104 of the applicator instrument during the step shown in Figure 11D. As previously mentioned, although the teeth of the insertion fork 220 have been directed around the sides of the initial surgical clip 232A, the trigger spring lock prevents further distal movement of the trigger rod 174 and the clevis insertion 220.

Figure HE shows the firing system during a later stage of the firing cycle. The user preferably continues to press the trigger 114 into the closed position. During this stage, bar 142 is moved more distally until protrusion of bar 158 joins distal end 160 of lower slot 156 of computer 154. Once the protrusion of the bar 158 contacts the distal end 160 of the lower slot 156, the additional distal movement of the bar 142 drives the computer 154 in a distal direction which, in turn, drives the impeller 166 to move distally to advance the surgical staples. The computer and the drive preferably move as one unit.

As the user continues to press the trigger 114, the bar 142 continues to move distally, encompassing the spring compartment 170 in a distal direction by connecting the main latch 150 with the spring compartment 170. The trigger rod 174 is held back so there is no more distal movement through the trigger rod lock (Figure 11D). As the spring compartment 170 moves in the distal direction, more energy is stored in the trigger spring 172 positioned within the spring compartment. Because it was compressed, the trigger spring is shorter compared to its original length with its right side facing inward on the proximal end of spring compartment 170. As the spring compartment 170 moves distally (counterclockwise), the return spring of the spring compartment 184 is compressed. In one embodiment, a flange extending from the spring compartment 170 is attached to the spring compartment return 184 to store energy in the spring return spring.

Figure 11E-1 shows the distal end 104 of applicator instrument 100 during the step shown in Figure HE. As computer 154 (Figure HE) moves distally via the projection on bar 158, computer 154 drives impeller 166 to move it in a distal direction, which advances the follow-up surgical staples 232B, 232C, and 232D towards the distal end of the applicator instrument. There is no further distal movement of the initial surgical staple 232A at this stage.

Figure 11F shows a sectional view of the firing system at a later stage of the firing cycle that occurs just prior to releasing firing rod 174. In one embodiment, spring compartment 170 includes a firing spring release ramp 175 that protruding from a surface of this. The trigger spring release ramp 175 is preferably aligned with the trigger spring release latch 180. As spring compartment 170 moves toward the distal end of the applicator instrument (counterclockwise), ramp 175 is attached to trigger spring release latch 180 to disengage release latch 180 from cruciform end 176 at the proximal end of the firing rod 174. Once the release latch disengages from the cruciform end 176 of the firing rod, the firing rod 174 is free to move distally. At that time, the energy stored in the trigger spring 172 is released to the trigger rod 174.

Figure 11F-1 shows the distal end 104 of the applicator instrument 100 during the firing cycle stage shown in Figure 11F. During this stage, the trigger spring release latch 180 is almost released from engagement with the cruciform end 176 of the trigger rod. Impeller 166 has been moved distally to advance follow-up surgical staples 232B-232D toward distal end 104 of applicator instrument 100.

Figure 11G shows a later stage of the firing cycle during which the firing rod is released to rapidly advance the insertion fork toward the distal end of the applicator instrument. During this stage, the trigger spring release ramp 175 pushes the trigger spring release latch 180 away from engagement with the cruciform structure 176. Release rod 174, free for distal movement, is rapidly advanced toward the distal end of the applicator instrument by means of release spring 172. Release spring 172 moves release rod 174 distally until the shock absorbing pad of the Firing rod 178 is attached to a PT stop wall in the housing. The trigger pad of the trigger rod 178 can be compressed slightly until the positive stop 179 in the cruciform structure 176 reaches the stop wall PT to stop any further distal movement of the trigger rod. Although the present invention is not limited by any particular theory of operation, it is believed that the firing rod cushion pad 176 prolongs the period of time to decelerate the firing rod 174 to stop the firing rod for a longer period of time. dragged on. The extension of the deceleration period of the trigger rod preferably reduces the impact force transmitted to the user and, furthermore, preferably reduces noise.

Figure 11G-1 shows the distal end 104 of the applicator instrument during the firing cycle stage shown in Figure 11G. The trigger spring has advanced the trigger rod 174 and insertion fork 220 rapidly in the distal (counterclockwise) direction. Initial surgical staple 232A is loaded from distal end 104 of applicator instrument 100 to secure a prosthetic device (eg, a mesh) to the tissue. As shown in Figure 11G-1, in a more distal position, the distal end 224 of insertion fork 220 has advanced beyond the distal end of end cap 122.

Referring to Figures 11G and 11G-1, the engagement of the positive stop 179 with the PT stop wall (Figure 11G) limits the further distal movement of the insert fork 220. Therefore, the combination of the shock absorber pad of Trigger rod 178, positive stop 179 and stop wall PT limit the maximum ejection of the initial surgical clip 232A and insertion fork from the applicator instrument. Excessive ejection of a surgical clip and / or insertion fork from a distal end of an applicator instrument has been observed to damage the prosthetic device or injure tissue. In one embodiment, during the firing cycle stage shown in Figures 11G and 11G-1, the follow-up surgical staples 232B-232D are not moved distally.

Referring to Figure 11H, in one embodiment, after delivery of the final surgical staple 232A, the firing cycle is not complete and the trigger cannot return to the fully open position shown in Figure HA. In one embodiment, during this stage of the firing cycle, trigger 114 must be further depressed to advance bar 142 further toward the distal end of the applicator instrument. In one embodiment, the pawl 144 that attaches to the teeth at the bottom of the bar 142 prevents the bar 142 from changing direction to move proximally until the projection 145 on the pawl 144 clears the proximal end of the bar 142. If an operator stops the trigger by pulling it before projection 145 on pawl 144 clears the proximal end of bar 142, trigger 114 freezes in position and does not return to the fully open position. Therefore, an operator must continue to pull the trigger, which continues the movement of the bar toward the distal end of the applicator instrument. As bar 142 continues to move distally, the projection on bar 158 moves computer 154 distally, resulting in distal movement of impeller 166 to drive surgical staples. When the computer is moved in the distal direction, the upper slot 162 of the computer 154 is further preferably attached to a tab 163 on the lockout counter 164 to at least partially rotate a lockout indicator, as will be described in detail below. continuation.

Referring to Figure 11H, as bar 142 moves in the distal direction, the main lock 150 approaches a distal opening in the main lock track 152. Once the main lock 150 reaches the distal opening of the main latch track 152, the main latch 150 is free to allow the bar 142 to disengage from the spring compartment 170. After decoupling, spring compartment 170 is free to independently move the bar. In one embodiment, the decoupled spring compartment moves toward the proximal end of the applicator instrument due to the forces provided by the return spring of spring compartment 184.

Figure 11H-1 shows distal end 104 of applicator instrument 100 during the firing cycle stage shown in Figure 11H. Insertion fork 220 can no longer move distally due to the stop wall PT on the handle that attaches to the positive stop at the cruciform end of the trigger rod. However, the additional distal movement of bar 142 continues the movement of computer 154 counterclockwise which, in turn, moves impeller 166 in a distal direction to advance follow-up surgical staples 232B, 232C and 232D toward the distal end 104 of applicator instrument 100.

Figure 111 shows the main lock 150 after it has reached the distal opening in the main lock rail 152. Once the main lock 150 reaches the distal opening, the main lock 150 is free to allow the bar 152 to disengage. of the spring compartment 170. Once the main latch 150 disengages the bar 142 from the spring chamber 170, the spring chamber 170 and the bar 152 move independently of each other. Referring to Figure 111, as mentioned above, bar 152 cannot move proximally until projection 145 on ratchet 146 clears the right end of bar 152.

Figure 111-1 shows the distal end 104 of the applicator instrument 100 after decoupling the main latch 150 from the spring compartment 170. As the trigger compresses, the driver 166 moves distally to drive the surgical clips 232B, 232C and 232D in a distal direction.

Referring to Figure 11J, as trigger 114 compresses, bar 142 advances computer 154 distally. Further distal movement of computer 154 moves impeller 166 distally and moves tab 163 on lockout counter 164 distally. The tab 163 of the lockout counter 164 is preferably attached by friction to the top slot 162 of the computer 154. Figure 11J-1 shows the distal end 104 of the applicator instrument 100 during the firing cycle stage shown in Figure 11J.

Referring to Figure 11K, in one embodiment, after disengaging the main latch 150 from the spring compartment, the spring return from the spring compartment 184 drives the spring compartment 170 to move it proximally. As spring compartment 170 moves to the right, spring compartment 170 pulls trigger rod 174 toward the proximal end of applicator instrument 100. Therefore, spring compartment 170 and trigger rod 174 move as a unit toward the proximal end of the applicator instrument while bar 142 continues to move toward the distal end of the instrument under the force of trigger 114. In one embodiment , the protrusion of the bar 158 continues the movement of the computer 154 distally to compress the damper spring 186. In one embodiment, damper spring 186 preferably gradually reduces user compression of the trigger when computer 154 pushes it.

Figure 11K-1 shows the distal end 104 of the applicator instrument 100 during the step shown in Figure 11K. After the primary latch releases the spring compartment from the bar, the spring compartment moves to the right to retract trigger rod 174 and insert fork 220. As shown in Figure 11K-1, the initial surgical staple 232A remains implanted in the tissue, while teeth 290, 294 have been removed from grooves 272, 274 in the initial surgical staple.

Referring to Figure 11L, once trigger 114 is fully compressed, the right end of bar 142 clears pawl 144. As a result, bar 142 is now free to move in a proximal direction. When the trigger 114 is fully depressed, the projection on the bar 158 preferably drives the computer 154 to a more distal position. In turn, the top slot 162 of the computer has preferably advanced the lockout counter 164 one half of a cycle. With the trigger in the fully compressed position, the trigger damping pad 132 is attached to a stop wall of the trigger guide 129 to dampen the deceleration of the trigger.

Figure 11L-1 shows the distal end 104 of the applicator instrument 100 during the firing cycle stage shown in Figure 11L. The distal movement of the computer produces the distal movement of the impeller 166. In one embodiment, when the trigger is depressed to the fully closed position, the second surgical staple 232B is advanced to the position of the initial surgical staple, the third surgical staple 232C is advanced to the first follow-up position and the fourth staple Surgical 232D is advanced to the second follow-up position. At the firing cycle stage shown in Figure 11L-1, the extended insert fork 220 and the extended impeller 166 deflect mounting sheet 228 downward. When the trigger begins to move to the open, uncompressed position , the driver 166 and the insertion fork 220 retract, allowing the mounting sheet 228 to move the initial surgical clip 232B into alignment with the teeth of the insertion fork.

Referring to Figure 11M, in one embodiment, when trigger 114 rotates back to the open, uncompressed position, bar 142 moves in a proximal direction. At this stage the pawl 144 prevents the bar 142 from changing direction until the bar reaches a fully retracted position. As the bar 142 moves proximally, the main latch 150 moves under the rail of the main latch 152.

Figure 11M-1 shows distal end 104 of applicator instrument 100 during the firing cycle stage shown in Figure 11M. The new final surgical staple 232B is located under the extended impeller 166 and partially extended insertion fork 220. The extended impeller and extender insertion fork keep mounting sheet 228 and mounting sheet holder 226 offset in one down position. Mounting sheet 228 cannot pass into a vertical position due to blockage by impeller 166 and insert fork 220.

Referring to Figure A, in one embodiment, the spring return of spring compartment 184 returns spring compartment 170 to its initial proximal position. In turn, proximal movement of spring compartment 150 retracts trigger rod 174 and insertion fork at the distal end of the applicator instrument. When the trigger is moved to the fully open position, bar 142 further reaches the most proximal position. As bar 142 reaches the proximal end of its reach, main latch 150 is propelled upward by means of a main latch ramp 155 adjacent a proximal end of housing 106. With bar 142 in a retracted position, the Ratchet 144 moves to a neutral position under bar 142. At this stage bar 142 is free to move distally and ratchet 144 does not limit its distal movement.

Figure 11N-1 shows the distal end 104 of the applicator instrument during the final stage of the firing cycle shown in Figure 11N. As shown in Figure 11N-1, the impeller 166 and insert fork 220 fully retract; therefore, they allow mounting sheet 228 to deflect upward to align initial surgical staple 232B with teeth of insertion fork 220.

In one embodiment, the applicator instrument of the present invention can be used to repair a defect, such as an inguinal hernia, that is located in the inguinal tissue, such as the inguinal floor. Generally, an inguinal hernia can be accessed through the iliac muscle. As can be seen, there is a network of vessels and nerves in the area of a typical inguinal hernia that requires a surgeon to perform hernia repair with great skill and care. For example, in the aponeurosis of the transverse abdomen, an internal ring allows the gastric vessels and vas deferens to expand over an edge of the inguinal ligament. A femoral canal is located near the Cooper's ligament and contains external iliac vessels and inferior epigastric vessels.

In many cases, the edge of the inguinal ligament and Cooper's ligament function as anatomical landmarks and support structures to support surgical staples, such as those mentioned above. Surgeons commonly call the area containing the external iliac vessels and the vas deferens Doom triangle. Therefore, care must be taken when dissecting, suturing, or clamping within this area.

A mesh or prosthetic patch can be placed over an inguinal hernia. The mesh patch can have the desired configuration, structure or material. In one embodiment, the mesh patch may be made of PROLENE ™ (a known polymer made of fibers) and may preferably be configured as mesh.

The mesh patch can be placed over the inguinal hernia to provide a sufficient barrier to the internal viscera (not shown) of the abdomen that in any other way tends to protrude through the inguinal hernia and causes the patient a lot of pain and discomfort. After placing the mesh patch on the groin floor, the mesh patch is ready to attach to the groin floor.

Referring to Figures 12A through 12D, in one embodiment, a distal end 104 of an applicator instrument 100 is placed over a prosthetic device 270 to secure a prosthetic device, such as a mesh patch, to tissue T. The prosthetic device may be a surgical mesh that has 272 strands running through it. The tips of each surgical staple are preferably separated from each other to increase the chances that the surgical staple will adhere to at least one of the 272 strands. The distal end 104 of instrument 100 preferably includes an end cap 122 having grooves 242 that facilitate grasping the instrument in place on prosthetic device 270.

Referring to Figure 12A, applicator instrument 100 preferably includes an outer tube 116 around a die cover 200 and an anti-recoil die 208. End cap 122 engages with outer tube 116, die cover 200, and the anti-recoil die 208. The die cover preferably has one or more projections for die cover springs 202 to press against the inner surface of outer tube 116 to produce a snug fit between inner dies 200, 208 and outer tube 116. The Applicator instrument includes insertion fork 220 having teeth protruding from the distal end thereof. One of the teeth 294 has an internal rib 296 that extends over the longitudinal axis AA of the applicator instrument to engage a rod in one leg of the surgical clip. The applicator instrument includes the stacked sheet unit that includes mounting sheet holder 226 and mounting sheet 228 for holding surgical clips in alignment with teeth 294 of insertion fork 220.

The impeller 166 is preferably arranged between the insert fork and the anti-recoil die. Impeller 166 includes drive protrusions 230 to drive surgical clips toward the distal end of the applicator instrument. The anti-recoil die has anti-recoil protrusions 212 that prevent the surgical clips from moving proximally.

In Figure 12A, the trigger system is positioned in a first stage of a trigger cycle. The insertion fork 220 and the impeller 166 retract and the stacked blade unit maintains the initial surgical staple 232A in alignment with the at least one tip 294 of the insertion fork 220.

Figure 12B shows a later stage of the firing cycle when the at least single tip 294 of the insertion fork has been distally directed to engage the grooves in the initial surgical staple 232A. During steering, insert fork 220 moves distally in a ratio proportional to the ratio at which the trigger is depressed. During steering, the protrusion of the mounting blade 229 and the mounting blade 228 stabilize and prevent the final surgical clip 232A from moving distally.

In Figure 12C, after storing the potential energy in the trigger spring, trigger rod 174 is released to supply the initial surgical clip 232A from applicator instrument 100. The trigger rod drives insertion fork 220, which at in turn, it drives the initial surgical staple 232A through the prosthetic device to implant the tips of the surgical staple into T tissue to attach the prosthetic device to T tissue. During implantation into the tissue, the teeth of the insertion fork preferably support the initial surgical staple 232A to prevent the initial surgical staple from bending or twisting. As insertion fork 220 and trigger rod 174 direct initial surgical clip 232A into the prosthetic device and T-tissue, follow-up surgical clip 232B is preferably held fixed.

Referring to FIG. 12D, in one embodiment, during a later stage of the firing cycle, the trigger is further pulled to advance the impeller 166 toward the distal end of the applicator instrument 100. The drive nose 230 on the impeller 166 engages preferably to the follow-up surgical staple 232B to move the follow-up surgical staple 232B distally. During this stage, the trigger rod is disengaged from the bar so that insertion fork 220 is free to retract and disengage from the supplied surgical clip 232A.

Referring to Figure 12E, when the trigger is fully closed, the follow-up surgical clip 232B has been advanced to a stacking position by means of the impeller 166. The stacked sheet unit cannot move the second surgical staple 232B in alignment with the teeth at the end of the insertion fork 220 because said movement was blocked by the extended impeller 166 and the at least the only insertion fork partially extended 220.

During a later stage not shown in Figure 12E, the trigger returns to the open position and the driver and insertion fork are moved proximally to the positions shown in Figure 12A. When the impeller 166 and insertion fork 220 are retracted to the initial position shown in Figure 12A, the stacked blade unit is free to move the second surgical staple 232B in alignment with the at least one tooth 294 of the insertion fork 220. The applicator instrument is now ready to begin a second firing cycle during which the second surgical staple 232B is supplied from the applicator instrument for implantation into prosthetic device 270 and tissue T.

In one embodiment, the applicator instrument includes a locking indicator system that locks the applicator instrument to prevent application of the surgical clips after all surgical clips have been delivered. Referring to Figure 13A, in one embodiment the lockout indicator system preferably includes a lockout counter 364 having a lockout counter overhang 365. The blocking counter preferably moves distally and proximally on the longitudinal axis AA of the applicator instrument. The protrusion of the lock counter 365 is preferably aligned with the upper slot 362 of the computer 354 such that the upper slot 362 has the ability to slide over the protrusion of the lock counter 365. In one embodiment, the protrusion of the lockout counter 365 has an external dimension adapted to the path within the upper slot 362 of computer 154; however, preferably, frictional contact exists between the lock counter protrusion 365 and the top slot 362 as the lock counter protrusion moves through the top slot 362.

In one embodiment, when the trigger of the applicator instrument is pulled, the bar moves in the distal direction which, in turn, moves the computer 354 distally (to the left). Referring to Figure 13B, when computer 354 is moved in the distal direction, top slot 362 of computer 354 slides over the protrusion of lockout counter 365 of lockout counter 364. The frictional engagement between the top slot 362 and the protrusion of the lockout counter 365 moves the lockout counter 364 distally which, in turn, rotates the lockout indicator 375 in a counter-clockwise direction.

Figures 14A to 14E show a lock indicator system in accordance with an embodiment of the invention. The components around the lock indicator system were discarded to simplify the description of the modality. Referring to Figure 14A, the lock indicator system preferably includes the lock counter 364 having the protrusion of the lock counter 365. Lockout counter 364 includes a first tooth 380 adjacent a proximal end of the lockout counter and a second tooth 382 adjacent to the direction of the lockout counter. As mentioned in the present description, the lockout counter 364 is adapted to move distally and proximally on the longitudinal axis AA of the applicator instrument.

The lock indicator system includes a lock indicator 375 having a leading edge 384 with an alignment notch 386 and a lock notch 388. The alignment notch 386 is preferably used to properly align the lock indicator 375 during initial unit of the lock indicator system. Lock notch 388 provides a larger opening in leading edge 384 that allows the locking pin to drop to lock the firing system.

In one embodiment, the lock indicator system includes a lock pin 390 having a lock tab 392 that attaches to the leading edge 384 of the lock indicator and a lock pin spring 394 that drives the lock pin 390 into a downward direction once lock tab 392 aligns with lock slot 388.

Referring to Figure 14B, when computer 354 is moved to the distal end of the applicator instrument (counterclockwise in Figure 14B), top slot 362 moves the protrusion of lockout counter 365 distally which, in turn, moves lock counter 364 distally. As the lockout counter 364 moves distally, the first tooth 380 adjacent the proximal end of the lockout counter 364 engages with the teeth at the bottom of the lockout indicator 375. Engaging the first tooth 380 of the lockout counter 364 with the teeth at the bottom of the lockout indicator 375 rotates the lockout indicator in a counter-clockwise direction called Rp As the lockout indicator 375 rotates in a counterclockwise, the lock tab 392 slides over the leading edge 384 of the lock counter 375. As long as the locking tab 292 is in contact with the leading edge 384, the locking pin cannot fall.

Referring to Figure 14C, computer 354 continues to move distally until the trigger is fully compressed. When computer 354 is moved to its most distal position, top slot 362 continues to drive the lock counter protrusion to move distally. When computer 354 has advanced to the most distal position (Figure 14C), computer 154 can move in a proximal (right) direction as the trigger is opened. When computer 354 is moved proximally, the computer, in turn, will move lockout counter 364 in a proximal direction such that the second tooth 382 in the lockout counter engages the teeth at the bottom of the lock 375. The second tooth 382 on the lock counter further rotates, preferably, the lock counter 375 in a counter-clockwise direction called Rj.

In one embodiment, a full firing acid causes the lockout counter 364 to move distally, and then proximally. As the lockout counter moves distally to its most distal position, the lockout counter 364 rotates the lockout indicator 375 by approximately one additional 1/58 rotation. As the lockout counter 364 moves to its most proximal position, the lockout counter rotates the lockout indicator 375 again in approximately 1/58 rotation. Therefore, each complete firing cycle causes the 375 Lock Indicator to rotate in approximately 1/29 rotation. Eventually, the lock indicator 375 will rotate fully so that the lock tab 392 aligns with the lock slot 388 formed in the leading edge 384 of the lock indicator. In other embodiments, the lock indicator may rotate more or less than the example below.

Figure 14D shows the blocking indicator system immediately before the firing system locks to stop firing. A locked state can occur after all surgical staples have been supplied. In Figure 14D, the lock indicator 375 has rotated such that the lock tab 394 is adjacent to one edge of the lock slot 388.

Referring to Figure 14E, in one embodiment, when computer 354 is moved proximally to the end of a trigger squeeze, lockout counter 364 rotates lockout indicator 375 in a counter-clockwise direction so that lock tab 392 aligns with lock slot 388. Once lock tab 392 aligns with lock slot 388, lock pin 390 falls into the lock slot to lock the firing system. Locking pin spring 394 can drive locking pin 390 to fall.

Referring to Figure 15A, in one embodiment, after all surgical clips have been supplied, the lock indicator 375 has rotated such that the lock tab 392 is aligned with the lock slot 388. At this stage the spring of the lock pin 394 drops lock pin 390 so that a latch 396 at a lower end of lock pin 390 aligns with a flange 345 on bar 342.

Referring to FIG. 15B, in one embodiment, during the next firing cycle, bar 342 is moved in the distal direction so that bar tab 345 engages with the proximal end of latch 396 of locking pin 390. . Referring to Figure 15C, in one embodiment, as the bar is moved distally, the bar tab 345 causes latch 396 at the lower end of locking pin 390 to move upward as the Bar 342 continues its movement in a distal direction.

Referring to Figure 15D, in one embodiment, during a later stage, the tab on bar 345 is moved distally to latch 396. In Figure 15E, latch 396 causes bar 342 to no longer move in a proximal direction. . At this stage the trigger is preferably fully closed and is prevented from returning to the trigger open position by engagement of latch 396 with bar tab 345.

Referring to Figure 16A, in one embodiment, a surgical staple 432 has a distal end 450 and a proximal end 452. Surgical staple 432 includes a first leg 454 that has a first tip 456 adjacent to distal end 450. Surgical staple it preferably includes a second leg 458 having a second tip 460 adjacent to the distal end 450. Proximal end 452 of surgical staple 432 includes a bridge 462 connecting the first and second legs 454, 458, respectively. The bridge may include a concave inner surface 465 and a convex outer surface 467.

With reference to Figures 16A and 16B, the first leg 454 preferably terminates in a first blind path 480 and the second leg 458 obviously terminates in a second blind path 482. The respective blind pathways 480, 482 may be formed in the Tip tracking surfaces and are preferably located directly over the center of each tip 456, 460. Preferably, the blind vias 480, 482 are practically aligned with the distal points of the tips to prevent the tips from flexing and / or to direct insertion forces directly behind each penetrating distal point.

Referring to Figures 17A through 17C, in one embodiment a surgical staple 532 includes grooves 572 pressed into the outer surfaces of the first and second legs 554, 558, respectively. Surgical clip 532 is applied by means of an insert fork 520 having a distal end 524 with a first tooth 590 and a second tooth 594. The first tooth 590 includes an internal rib 592 that slides on the first rod 572. Second tooth 594 preferably includes a second internal rib 596 adapted to slide over a second slot (not shown) in second leg 558.

Figure 17B shows the first and second teeth 590, 594, respectively, of insert fork 520 which slides over the grooves in the first and second legs of surgical clip 532. Figure 17C shows teeth 590, 594 fully seated on the first and second legs 554, 558, respectively, of surgical clip 532. Insertion fork 520 preferably provides rigidity to surgical clip 532 during implantation of the surgical clip into tissue. In one embodiment, the distal ends of the first and second teeth 590, 594 are preferably axially aligned with the first and second tips 556, 560 at the distal end of the surgical clip. The insertion force is preferably transmitted to the surgical staple 532 by means of the distal ends of the teeth 590, 594 and by a concave seat 525 of the insertion fork 520.

Referring to Figures 18A and 18B, in one embodiment a surgical staple 632 includes a first leg 654 having a first tip 656 and a second leg 658 having a second tip 660. The first leg 654 includes a first rib 672 which is it extends from a proximal end 652 to a distal end 650 of surgical clip 632. Second leg 658 has a second rib 674 that is formed in the same manner as first rib 672. As shown in Figure 18B, the first pointed tip 656 is sandwiched from the second pointed tip 660. The sandwiched tips preferably reduce the penetration force by sandwiching the peak forces encountered during insertion. The surgical staple further preferably includes at least one tab 664 on the first leg 672 sandwiched from the at least one tab 666 on the second leg 674.

Referring to Figures 19A through 19C, in one embodiment, the surgical staple 632 of Figures 18A and 18B is implanted with the use of an insertion tool 620 having intercalated tips 690A, 690B. The surgical staple preferably includes blind vias 680, 682 that are aligned with the pointed tips 656, 660. Inserted tips 690A, 690B of insertion tool 620 can be inserted into blind vias 680, 682 located behind the tips pointy 656,660. The teeth provide support for the surgical staple as the staple implants and provide an insertion force that is applied to the distal surgical staple up to the proximal end of the surgical staple.

Figures 20A to 20C show surgical clip 632 of Figures 18A to 18B that is implanted with the use of insertion tool 620 of Figures 19A to 19C. Referring to Figure 20A, in one embodiment, a distal end of an applicator instrument rests on a prosthetic device 670 overlying the T-tissue. Insertion tool 620 is advanced to the distal end of applicator instrument 600 so that first and second pointed tips 656, 660 are adjacent to the prosthetic device. As shown in Figure 20A, the second pointed tip 660 engages the prosthetic device before the first pointed tip 656; thus, peak forces encountered during implantation are interspersed. Figures 20B and 20B1 show the pointed tips 656, 660 of surgical clip 632 which are pressed through the prosthetic device and into the tissue. Overlapping teeth 690A, 690B at the distal ends of insertion tool 620 support the pointed tips 656, 660 of the surgical staple and extend, preferably, through the prosthetic device and into tissue during staple insertion surgical. Figure 20C shows the surgical staple 632 in place to hold the prosthetic device 670 to the T-tissue after retracting the insertion tool. Bridge 662 of the surgical clip preferably covers one or more strands of the prosthetic device to capture the strands between the first and second legs 654, 658.

Referring to Figures 21A and 21B, in one embodiment a surgical staple 732 includes inwardly facing tabs 764, 766. Referring to Figure 21B, in one embodiment, the tabs are preferably interspersed from the distal end of the surgical staple. After implantation, inwardly facing tabs 764, 766 preferably squeeze the tissue within the legs to increase the pulling force. The surgical clip preferably includes a bridge 762 that has a practically flat internal surface that allows greater capture of the prosthetic device and more aids in aligning the surgical clip as it is advanced toward the distal end of an insertion tube .

Although the present invention is not limited by any particular theory of operation, inwardly facing tabs are believed to provide a greater point-to-point distance for a specific surgical element width to reduce the chance that the surgical clip will not capture a strand upon anchoring large open pore meshes. The inwardly facing tabs allow the outer surfaces of the legs 754, 758 to be straight to facilitate delivery of the surgical staple into a tube.

Referring to Figures 21A and 21B, in one embodiment, legs 754, 758 of surgical clip 732 have opposite internal ribs 772, 774. Ribs 1T¿, 774 are preferably accessible at the proximal end of the surgical clip and adjacent to bridge 762 of the surgical clip. The internal ribs formed on the first and second legs 754, 758 preferably guide the teeth in an insertion tool to the blind vias at the distal ends of the legs 754, 758. Tapered tips 756, 760 are believed to increase the penetration force compared to the carved tips, and that the conical tips can also increase the extraction force by not cutting a path, rather stretching the hole created by the conical tips. Figures 22A to 22C show an insertion tool 720 having distal teeth 790A, 790B that can be advanced on the internal ribs 772, 774. The distal ends of the teeth are preferably joined against the blind ways 680, 682 which end adjacent to tips 756, 760.

Referring to Figure 23, in one embodiment, a surgical staple 832 has tabs 864, 866 that are set out of plane. The out-of-plane tabs preferably improve the retention force after implantation into tissues. Referring to Figure 24, in one embodiment a surgical staple 932 is pinless and is preferably pushed from a proximal end during placement in a prosthetic device, mesh, or tissue.

Referring to Figures 25A and 258, in one embodiment, a surgical staple 1032 is placed with the use of the needle assisted insert. Surgical staple 1032 has flanged tips 1056, 1060 that have perforations. In one embodiment, the surgical staple 1032 is made of a relatively soft material, but can also be inserted by means of hard prosthetic devices, meshes, and tissue with the use of a needle assisted insertion tool 1020 having needle points 1090A, 1090B that can be passed through the holes in tips 1056, 1060.

Referring to Figure 26, in one embodiment, a surgical staple 1132 has unidirectional tabs. Each of the tabs 1164, 1166 preferably has a notch 1165, 1167 which allows the tabs to flex inwardly during insertion and outwardly during retraction to make it difficult to remove the tabs from prosthetic devices, mesh, and / or tissue during retraction of the surgical staple.

Referring to Figure 27, in one embodiment, an applicator instrument 1200 has an alignment notch 1225 at a distal end 1204 thereof. As shown in Figures 28A and 28B, in one embodiment, alignment notch 1225 preferably facilitates alignment of the instrument on strand 1270 of a prosthetic device to ensure that the strand is captured between legs 1254, 1258 of the surgical staple 1232 when placed from the applicator instrument.

Referring to Figure 29, in one embodiment, an applicator instrument 1200 has an outer tube 1216 that has one or more alignment references 1290 that extend away from the distal end 1204 and across the entire outer surface of the outer tube 1216. The reference Alignment 1290 preferably extends over the longitudinal axis AA of the instrument to provide an alignment reference to align the instrument on a strand 1270 of a prosthetic device.

Referring to Figures 30A through 30B, in one embodiment, a surgical staple 1332 preferably includes a distal end 1350 and a proximal end 1352. Surgical staple 1332 preferably includes a first portion 1354 having a first insertion tip 1356 with a distal point 1357, provided at a distal end of the first leg and a second leg 1358 having a second insertion tip 1361, with a distal point 1361, provided at a distal end of the second leg. The respective distal tips 1357, 1361 may have sharp edges or may be more obtuse. In one embodiment the first and second tips 1356, 1360 have blunt distal drill tips 1357, 1361, respectively. The blunt tips allow the surgical stapler to penetrate tissue while minimizing unwanted penetration into the hand of an operator, such as a surgeon.

In one embodiment, surgical clip 1332 preferably includes a bridge 1362 adjacent proximal end 1352 of surgical clip connecting proximal ends of the first and second legs 1354, 1358. Surgical clip 1332 preferably includes, therefore, minus a first tab 1364 protruding rearwardly from first tip 1356 and at least a second tab 1366 protruding rearwardly from second tip 1360. Although only one tab is shown for each leg, other surgical staples may have multiple tabs on each leg or insertion tip. In one embodiment, the first and second tips 1356, 1360 may be tapered.

In one embodiment the first and second tips 1356, 1360 are biased outward with respect to the longitudinal axes of the first and second legs respectively 1354, 1358. In one embodiment, the first and second insert tips 1356, 1360 are biased, preferably , out from a center of surgical staple 1332. In one embodiment, the first and second insertion tips 1356, 1360 are preferably asymmetric and are configured to extend outward from the center of surgical clip 1332.

In one embodiment the distance between the distal pierce points 1357,1361 of the more distal ends of the respective first and second points 1356, 1360 is preferably greater than the distance between the opposite surfaces of the first and second legs 1354, 1356. The greater relative distance between the distal drill tips of the first and second tips 1356, 1360 preferably ensures that the surgical stapler will hold more strands of a porous prosthetic device, such as the strands of a surgical mesh. In one embodiment, the outwardly biased distal tips provide an increased ability to hold surgical mesh fibers, where the mesh fibers are separated from one another without the need to increase the distance between each leg.

In one embodiment, bridge 1362 preferably includes a concave inner surface 1368 facing the distal end 1350 of the surgical stapler 1332 and a convex outer surface 1370 facing the proximal end 1352 of the surgical stapler. In one embodiment, the first leg 1354 has an external wall having a first rod 1372 that extends along a longitudinal axis of the first leg. In one embodiment, the first slot 1372 is in substantial alignment with the distal point 1357 of the first insertion tip 1356. In one embodiment, the second leg 1358 includes a side wall having a second slot 1374 that extends along the longitudinal axis of the second leg. In one embodiment, the second slot 1374 preferably aligns with the distal point 1361 of the second insertion tip 1360.

In one embodiment, the proximal face of the first insertion tip 1356 includes a first bearing surface of the insertion tool 1380 adapted to receive a distal end of a first tooth of an insertion fork. The proximal face of the second insertion tip 1360 preferably includes a second bearing surface of the insertion tool 1382 adapted to receive a distal end of a second tooth of the insertion fork. In one embodiment, the convex bearing surfaces of the insertion tool 1380, 1382 align substantially preferably with the distal drill tips 1357, 1361 of the first and second insertion tips 1356, 1360. The distal ends of the Teeth of the insert fork may have surfaces (eg, concave) that accommodate the bearing surfaces of the insert tool 1380, 1382.

In one embodiment, the first leg 1354 of the surgical staple 1332 has a first hinge joint 1384 that divides the first leg into a proximal segment 1386 and a distal segment 1388 that includes the first insertion tip 1356, the first distal point 1357, the first tab 1364, and the first bearing surface of the insertion tool 1380. The first link joint 1384 preferably allows distal segment 1388 of first leg 1354 to deviate relative to proximal segment 1386 of first leg. In one embodiment, the proximal segment 1386 of the first leg, the first hinge joint 1384, and the distal segment 1388 of the first leg are all made of the same material, such as a polymer material.

In one embodiment, the second leg 1358 of the surgical staple 1332 has a second hinge joint 1390 that divides the second leg into a proximal segment 1392 and a distal segment 1394 that includes the second insertion tip 1360, the second distal point 1361, the second tab 1366, and the second bearing surface of the insertion tool 1382. The second hinge joint 1390 preferably allows the distal segment 1394 of the second leg 1358 to deviate relative to the proximal segment 1392 of the second leg. In one embodiment, the proximal segment 1392 of the second leg, the second hinge joint 1390, and the distal segment 1394 of the second leg are all made of the same material, such as a polymer material.

It has been observed that placing surgical staples (eg, staples, tacks, etc.) in tissue to secure an implant (eg, a surgical mesh) to the tissue can result in patient pain and / or discomfort due to the main points of the staples that impact the vessels or nerves that are present in the tissue. Thus, there is a need for improved surgical clips that minimize the likelihood that the main tips will impact vessels and / or nerves. Although the present invention is not limited by any particular theory of operation, it is believed that providing the articulation joints 1384,1390 in the respective first and second legs of a surgical clip will allow the distal segments 1388, 1394 of the legs to insert tips 1356, 1360, respectively, are offset, if necessary, to limit the impact of insert tips on vessels and / or nerves that are present in tissue. In other words, if the insert tips 1356, 1360 are held against the vessels and / or ribs, the articulation joints 1384, 1390 allow the respective insert tips 1356,1360 to deflect away from the vessels and / or ribs to reduce the level of impact and minimize the patient's pain and / or discomfort.

In one embodiment, only one of the legs of the surgical staple can have a joint. In one embodiment, one or more of the legs of the surgical clip may have one or more articulation joints. In one embodiment, the articulation joint may be an omnidirectional joint that allows the insertion tip to deviate in all directions relative to the proximal leg segment.

In one embodiment, the surgical staple 1332 can be made of absorbable and / or non-absorbable materials. Preferred absorbable materials include PDS, PDS / lactidaglycolide combinations, PLA, etc. In one embodiment, each surgical staple is sized to fit within a 5mm OD tube (typically, the size of a trocar cannula). In one embodiment, the surgical staple is manufactured by molding; however, with minor modifications, other processes such as casting, die-cutting, and turning can be used. In one embodiment, the surgical staples can be extruded into a general configuration and subsequently formed.

Referring to Figure 30C, in one embodiment, an insertion fork 1396 is used to insert surgical clip 1332 into the tissue. Insertion fork 1396 is preferably supplied at a distal end of a trigger row of the applicator instrument described in the present disclosure. In one embodiment, insertion fork 1396 has a distal end engaged to accommodate one or more surfaces of surgical clip 1332. In one embodiment, the distal end of insertion fork 1396 includes a first tooth 1398A having a first internal rib formed therein and a second tooth 1398B having a second internal rib formed therein. As described above, in operation, the opposing internal ribs of the first and second teeth 1398A, 1398B are preferably adapted to slide over the grooves 1372, 1374 (Figure 30A) provided on the first and second legs 1354, 1358 of the surgical staple. The engagement of the internal ribs with the grooves preferably aligns the element of surgical clip 1332 with the distal end of insertion fork 1396 and stabilizes the surgical clip during implantation into tissue. In one embodiment, the most distal tips of the first and second teeth 1398A, 1398B are advanced until they engage with the insert tool bearing surfaces 1380, 1382 provided at the distal ends of the first and second tips of insert 1356, 1360.

Although the present invention is not limited by any particular theory of operation, it is believed that providing an insert fork 1396 with grooved teeth that engage the rods of the external surfaces of the legs of a surgical staple will improve the stability and control of the surgical stapler by dispensing the surgical staple from the distal end of the applicator instrument. Furthermore, the insertion force is applied near the distal end of the surgical clip and not only on the proximal end of the surgical clip as in the prior art systems. This feature (i.e. applying insertion force on the surgical clip near the distal end of the clip) could allow the use of smaller and / or lower profile surgical clips.

Referring to Figure 30C, when the applicator instrument is triggered, insertion fork 1396 advances distally to drive insertion tips 1356, 1360 of surgical clip 1332 into tissue. When pushed into the tissue, the first and second legs 1354, 1358 of the surgical clip remain rigid due to the teeth 1398A, 1398B of the insert fork 1396, and due to the compressive forces provided by the insert fork at the insertion tips 1356, 1360 of the legs.

Referring to Figure 30D, in one embodiment, after the surgical clip has been inserted into the tissue and the insertion fork is retracted, the distal segments 1388, 1394 of the first and second legs 1354, 1358 are flexible and capable deviate in the presence of articulation joints 1384, 1390 in the legs. Joint joints 1384, 1390 allow distal segments 1388, 1394 of the legs and insertion tips 1356, 1360 associated with the distal segments to be deflected, if necessary, to limit the impact on the vessels and / or nerves that are present in the tissue, which will minimize the patient's pain and / or discomfort. In one embodiment, the spring-like properties present in the distal segments 1388, 1394 of the first and second legs 1354, 1358 can allow the surgical clip to automatically adjust for different tissue thicknesses. In one embodiment, as the insert tips 1356, 1360 are deflected, the insert tips move from the first undisturbed positions designated 1356A, 1360A to the second offset positions designated 1356B, 1360B, and the tabs 1364, 1366 become they move with the first and second insertion tips 1356, 1360 offset from the first designated non-offset position 1364A, 1366A to the second designated offset position 1364B, 1366B.

Referring to Figures 31A and 31B, in one embodiment, a surgical staple 1432 has a first leg 1454 with a slot 1472 and a first joint 1484 dividing the first leg into a proximal segment 1486 and a distal segment 1488. The The distal segment of the first leg includes a first insertion tip 1456 having a first distal point 1457. Surgical clip 1432 has a second leg 1458 with a slot 1474 and a second joint 1490 that divides the second leg into a proximal segment 1492 and a distal segment 1494. The distal segment of the second leg includes a second insertion tip 1460 it has a second distal point 1461.

In one embodiment, the first and second link joints 1484, 1490 define thinner sections of the respective first and second legs that provide flexibility between the proximal segments and the distal segments of each of the first and second legs. The first and second joint joints 1484, 1490 can be created during the formation of the first and second legs, such as during a molding or forming process, or can be formed by removing material from the first and second legs to create the joint joints 1484, 1490. In the embodiment shown in Figures 31A and 31B, the first and second joint joints 1484, 1490 have C-shaped cross sections that face each other.

The first link joint 1484 preferably allows distal segment 1488 and first insertion tip 1456 of first leg 1454 to deviate relative to proximal segment 1486 of first leg. In one embodiment, the proximal segment 1486 of the first leg, the first hinge joint 1484, and the distal segment 1488 of the first leg are all made of the same material, such as a polymer material.

The second link joint 1490 preferably allows the distal segment 1494 of the second leg 1458 and the second insertion tip 1360 to deviate relative to the proximal segment 1492 of the second leg. In one embodiment, the proximal segment 1486 of the second leg, the second hinge joint 1484, and the distal segment 1488 of the second leg are all made of the same material, such as a polymer material.

Referring to Figure 31C, in one embodiment, an insertion fork 1496 is used to insert surgical clip 1432 into the tissue. In one embodiment, the distal end of insertion fork 1496 includes a first tooth 1498A having a first internal rib formed therein and a second tooth B having a second internal rib formed therein. As described above, in operation, the opposing inner ribs of the first and second teeth 1498A, 1498B are preferably adapted to slide over the grooves 1472, 1474 (Figure 31A) provided on the first and second legs 1354, 1358 of the surgical staple. The engagement of the inner ribs with the grooves preferably aligns surgical clip 1432 with the distal end of insertion fork 1496 and stabilizes the surgical clip during implantation into tissue. In one embodiment, the more proximal tips of the first and second teeth 1498A, 1498B are advanced until they engage with the insert tool bearing surfaces 1480, 1482 provided at the proximal ends of the first and second tips of respective insert 1456, 1460.

Referring to Figure 31C, when the applicator instrument is triggered, insertion fork 1496 advances distally to drive insertion tips 1456, 1460 of surgical clip 1432 into tissue. When driven into the tissue, the first and second legs 1454, 1458 of the surgical clip remain rigid due to the teeth 1498A, 1498B of the insert fork 1496, and due to the compressive forces provided by the insert fork on the first and second insertion tips 1456,1460 of the first and second legs 1454,1458, respectively.

Referring to Figure 31D, in one embodiment, after the surgical clip has been inserted into the tissue and the insertion fork is retracted, the distal segments 1488, 1494 of the respective first and second legs are flexible due to the presence of the articulation joints 1484, 1490 on the legs. Joint joints 1484, 1490 allow the distal segments 1488, 1494 of the legs and insertion tips 1456, 1460 associated with the distal segments to be deflected, if necessary, to limit the impact on the vessels and / or nerves that are present in the tissue, which will minimize the patient's pain and / or discomfort. In one embodiment, the spring-like properties present in the distal segments 1488, 1494 of the first and second legs 1454, 1458 can allow the surgical clip to automatically adjust for different tissue thicknesses. In one embodiment, as the insert tips 1456, 1460 are deviated, the insert tips move from the first undirected positions 1456A, 1460A to the second deviated positions designated 1456B, 1460B, and the tabs 1464, 1466 move with the first and second insertion tips 1456, 1460 as they deviate from the first undirected positions 1464A, 1466A to the second deviated positions 1464B, 1466B.

Referring to Figures 32A and 32B, in one embodiment, a surgical staple 1532 preferably includes a distal end 1550 and a proximal end 1552. Surgical staple 1532 preferably includes a first leg 1554 having a first insertion tip 1556 provided at a distal end of the first leg and a second leg 1558 having a second insertion tip 1560 provided at a distal end of the second leg. Surgical clip 1532 preferably includes a bridge 1562 adjacent proximal end 1552 of surgical clip connecting proximal ends of first and second leg 1554, 1558. Surgical clip 1532 preferably includes at least a first tab 1564 projecting rearwardly from the first insertion tip 1556 and at least one second tab 1566 projecting rearwardly from the second insertion tip 1560.

In one embodiment, the first and second insertion tips 1556, 1560 are biased outwardly relative to the respective longitudinal axes of the first and second legs 1554, 1558. In one embodiment, the first and second insertion tips 1556, 1560 they have distal points 1557, 1561, respectively. Distal points 1557, 1561 can be sharp, obtuse, or blunt. In one embodiment, distal points 1557, 1561 are blunt to allow surgical clip 1532 to penetrate tissue while minimizing the possibility of unwanted penetration into the hand of an operator, such as a surgeon.

In one embodiment, the first leg 1554 has a first slot 1572 that extends along the longitudinal axis of the first leg. In one embodiment, the first slot 1572 is preferably in substantial alignment with the distal point 1557 of the first insertion tip 1556.

In one embodiment, the second leg 1558 has the second groove 1574 which extends along the longitudinal axis of the second leg 1558. In one embodiment, the second groove 1574 is preferably in substantial alignment with the distal point 1561 of the second insertion tip 1560.

In one embodiment, the first and second insertion tips 1556, 1560 are preferably biased outwardly from a center of the surgical clip 1532. In one embodiment, the first and second insertion tips 1556, 1560 are preferably asymmetric and are configured to extend outward from the center of surgical staple 1532.

In one embodiment, the proximal face of the first insertion tip 1556 includes a first bearing surface of the insertion tool 1580 adapted to receive a distal end of a first tooth of an insertion fork. The proximal face of the second tip of »

Insertion 1560 preferably includes a second bearing surface of insertion tool 1582 adapted to receive a distal end of a second tooth of the insertion fork. In one embodiment, the convex bearing surfaces 1580, 1582 are substantially preferably aligned with the distal tips 1557, 1561 of the respective first and second insertion tips 1556, 1560. In one embodiment, the distal ends of the teeth of an insert fork may have surfaces (eg, concave surfaces) that accommodate the respective concave bearing surfaces of the insert tool 1580,1582.

In one embodiment, the first insertion tip 1556 has a first articulation joint 1584 incorporated therein which is located between the first bearing surface of the insertion tool 1580 and the distal point 1557. The first articulation joint 1584 preferably allows , that the distal point 1557 of the first insertion tip 1556 deviates and / or flex relative to the remaining portion of the first leg 1554 that is proximal to the first joint 1584.

In one embodiment, the second insertion tip 1560 has a second articulation joint 1590 which is located between the second bearing surface of the insertion tool 1582 and the second distal point 1561. The second articulation joint 1590 preferably allows the second distal point 1561 of the second insertion tip 1560 deviates and / or flexes relative to the remaining portion of the second leg 1558 that is proximal to the second articulation joint 1590.

Referring to Figures 32A and 32C, in one embodiment, when the insertion tips are driven into the tissue by the insertion fork (not shown), the insertion tips and respective joint joints associated therewith are compressed to form solid structures that do not deflect or flex during insertion, due in part to the compression forces provided by the teeth of the insert fork (eg, see Figure 31C). Figure 32C shows the second insertion tip 1560 and the second distal point 1561 when driven into the tissue by an insertion fork. The second insertion tip

1560 and the associated second joint joints 1590 compress together to form a solid structure that does not deflect or flex during insertion into the tissue.

Referring to Figure 32D, in one embodiment, after the surgical staple 1532 has been inserted into the tissue and the insertion fork is retracted, the distal points 1557,

1561 of the respective first and second insertion tips 1556, 1560 are flexible due to the presence of the articulation joints 1584, 1590 at the respective insertion tips. Joint Joints 1584, 1590 allow distal tips 1557, 1561 to be deflected, if necessary, to limit the impact on the vessels and / or nerves that are present in the tissue, which will minimize patient pain and / or discomfort . In one embodiment, the spring-like properties present in distal tips 1557, 1561 can allow surgical clip 1532 to automatically adjust to different tissue thicknesses. In one embodiment, as the distal tips 1457, 1461 deviate in response to the impact of the vessels and / or nerves, the distal tips move from the first non-deviated positions designated 1457A, 146IA to the second deviated positions designated 1357B, 1361B, while tabs 1364, 1366 associated with the distal tips remain fixed in the tissue and do not move.

Referring to Figure 33, in one embodiment, a surgical staple 1632 may have a first leg 1654 with a first articulation joint 1684 and a second leg 1658 with a second articulation joint 1690. The surgical staple is generally similar in structure to the surgical staple shown and described above in Figures 31A to 31D. However, in the embodiment of Figure 33, the first and second joint joints 1684, 1690 are rotated approximately 90 ° relative to the orientation of the joint joints shown in the embodiment of Figures 31A to 31D. In one embodiment, the orientation and / or location of the articulation joints on the first and second legs can be modified so as to drive the deviation of the insertion tips in certain directions, to modify the deviation range of the legs and / or to modify the flexibility of the legs.

Referring to Figure 34, in one embodiment, a surgical staple 1732 has a first leg 1754, a second leg 1758, and a bridge 1762 that extends between the proximal ends of the first and second legs. In one embodiment, surgical clip 1732 preferably includes a tensioning element 1800 that is distal to bridge 1762 and that extends between the internal faces of the first and second legs 1754, 1758. In one embodiment, tensioning element 1800 includes a tension plate 1802 and a compressible spring 1804 that connects tension plate 1802 with bridge 1762. In one embodiment, tensioning element 1800 allows surgical clip 1732 to be used effectively. in fabrics that have various thicknesses by maintaining tension through tension plate 1802. In one embodiment, after the surgical clip 1732 is inserted into the tissue to secure a prosthetic device (eg, surgical mesh) to the tissue, if a gap remains between the bridge 1762 of the surgical clip and the prosthetic device, the tensioning member 1800 It fills the gap and provides tension on the prosthetic device and the outer surface of the tissue to effectively secure the prosthetic device to the tissue.

Referring to Figure 35, in one embodiment, a surgical staple 1832 has a first leg 1854, a second leg 1858, and a bridge 1862 that extends between the proximal ends of the first and second legs. In one embodiment, surgical clip 1832 preferably includes a tensioning band 1900 that is distal to bridge 1862 and that extends between the proximal faces of the first and second legs 1854, 1858. In one embodiment, the tensioning band 1900 has an arc shape with a convex surface facing the distal end 1850 of the surgical staple 1832. In one embodiment, the tensioning band 1900 allows the surgical staple 1832 to be used effectively in the fabrics that have various thicknesses by maintaining tension on the fabric through the 1900 tensioning band. In one embodiment, after inserting surgical staple 1832 into tissue to secure a prosthetic device (eg, surgical mesh) to tissue, if a gap remains between bridge 1862 and the prosthetic device, tension band 1900 fills the gap and it provides tension on the prosthetic device and the external surface of the tissue to effectively secure the prosthetic device to the tissue.

The titles used in the present description were used only for the purpose of organizing the text and are not intended to limit the scope of the description or the claims. As used in the present application, the word can is used in a permissive sense (that is, it has the potential for), and not in a mandatory sense (that is, it must). In the same way, the 10 words include, including and includes mean that they include but merely by way of illustration and not limitation. For ease of understanding, numerals have been used as a reference, where possible to designate similar elements common to the figures.

While the foregoing is directed to embodiments of the present invention, other additional embodiments of the invention may be devised without departing from the basic scope of the invention. As such, the scope of the present invention is limited only as set forth in the appended claims.

Contents3

172 members in 17 offices

This recordMember, by publication datePriority claim7 more offices are in the list below

Priority claims9

Priority claims
Document	Office	Kind	Date
13791950	United States of America	–	2013-03-09
201313791950	United States of America	A	2013-03-09
201313791950	United States of America	A	2013-03-09
2014017245	United States of America	W	2014-02-20
2014017245	United States of America	W	2014-02-20
13791950	–	–	–
PCTUS2014017245	–	–	–
US201313791950	–	–	–
WO2014US17245	–	–	–

Members172

Family members, oldest first
Document	Office	Kind
CA2761617A1	Canada	A1	2010-11-18
CA2761706A1	Canada	A1	2010-11-18
CA2761868A1	Canada	A1	2010-11-18
US2010292710A1	United States of America	A1	2010-11-18
US2010292712A1	United States of America	A1	2010-11-18
US2010292713A1	United States of America	A1	2010-11-18
US2010292715A1	United States of America	A1	2010-11-18
WO2010132280A1	World Intellectual Property Organization (WIPO)	A1	2010-11-18
WO2010132281A1	World Intellectual Property Organization (WIPO)	A1	2010-11-18
WO2010132282A1	World Intellectual Property Organization (WIPO)	A1	2010-11-18
US2011079627A1	United States of America	A1	2011-04-07
CA2760104A1	Canada	A1	2011-11-07
AU2010247959A1	Australia	A1	2011-12-08
AU2010247960A1	Australia	A1	2011-12-08
AU2010247961A1	Australia	A1	2011-12-08
WO2011155918A1	World Intellectual Property Organization (WIPO)	A1	2011-12-15
AU2010353301A1	Australia	A1	2012-01-19
IL216262D0	Israel	D0	2012-01-31
IL216270D0	Israel	D0	2012-01-31
IL216271D0	Israel	D0	2012-01-31
IL216272D0	Israel	D0	2012-03-01
KR20120018788A	Republic of Korea	A	2012-03-05
KR20120018789A	Republic of Korea	A	2012-03-05
MX2011012125A	Mexico	A	2012-03-07
MX2011012127A	Mexico	A	2012-03-07
MX2011012128A	Mexico	A	2012-03-14
EP2429413A1	European Patent Office (EPO)	A1	2012-03-21
EP2429414A1	European Patent Office (EPO)	A1	2012-03-21
EP2429417A1	European Patent Office (EPO)	A1	2012-03-21
EP2429419A1	European Patent Office (EPO)	A1	2012-03-21
KR20120028911A	Republic of Korea	A	2012-03-23
KR20120032478A	Republic of Korea	A	2012-04-05
CN102458266A	China	A	2012-05-16
CN102458267A	China	A	2012-05-16
CN102458268A	China	A	2012-05-16
WO2012064692A2	World Intellectual Property Organization (WIPO)	A2	2012-05-18
WO2012071150A2	World Intellectual Property Organization (WIPO)	A2	2012-05-31
MX2011012126A	Mexico	A	2012-06-04
WO2012071150A3	World Intellectual Property Organization (WIPO)	A3	2012-07-19
TW201233670A	Taiwan Province of China	A	2012-08-16
JP2012526615A	Japan	A	2012-11-01
JP2012526616A	Japan	A	2012-11-01
JP2012526617A	Japan	A	2012-11-01
JP2012526644A	Japan	A	2012-11-01
CN102802542A	China	A	2012-11-28
AU2013202209A1	Australia	A1	2013-05-02
WO2012064692A3	World Intellectual Property Organization (WIPO)	A3	2013-05-10
AU2011326107A1	Australia	A1	2013-05-30
RU2011150231A	Russian Federation	A	2013-06-20
RU2011150238A	Russian Federation	A	2013-06-20
RU2011150240A	Russian Federation	A	2013-06-20
RU2011150260A	Russian Federation	A	2013-06-20
EP2429417B1	European Patent Office (EPO)	B1	2013-06-26
DK2429417T3	Denmark	T3	2013-07-08
EP2626015A2	European Patent Office (EPO)	A2	2013-08-14
US2013218177A1	United States of America	A1	2013-08-22
EP2637575A2	European Patent Office (EPO)	A2	2013-09-18
AU350998S	Australia	S	2013-09-25
CN103338712A	China	A	2013-10-02
EP2643285A2	European Patent Office (EPO)	A2	2013-10-02
ES2427340T3	Spain	T3	2013-10-30
US8579920B2	United States of America	B2	2013-11-12
PL2429417T3	Poland	T3	2013-11-29
KR20130140091A	Republic of Korea	A	2013-12-23
CN103476738A	China	A	2013-12-25
USD698021S	United States of America	S	2014-01-21
US2014051884A1	United States of America	A1	2014-02-20
EP2626015A3	European Patent Office (EPO)	A3	2014-02-26
CA152526S	Canada	S	2014-04-14
US8728098B2	United States of America	B2	2014-05-20
US8728099B2	United States of America	B2	2014-05-20
AU2010247960B2	Australia	B2	2014-09-04
JP5602842B2	Japan	B2	2014-10-08
JP5602843B2	Japan	B2	2014-10-08
JP5602844B2	Japan	B2	2014-10-08
CA2903753A1	Canada	A1	2014-10-09
WO2014163814A1	World Intellectual Property Organization (WIPO)	A1	2014-10-09
SA111320934B1	Saudi Arabia	B1	2014-10-16
SA3676B1	Saudi Arabia	B1	2014-10-16
AU2010353301B2	Australia	B2	2014-10-30
AU2013202209B2	Australia	B2	2014-10-30
RU2532934C2	Russian Federation	C2	2014-11-20
RU2532936C2	Russian Federation	C2	2014-11-20
US8894669B2	United States of America	B2	2014-11-25
RU2013126592A	Russian Federation	A	2014-12-20
US2014379001A1	United States of America	A1	2014-12-25
US8920439B2	United States of America	B2	2014-12-30
RU2013128562A	Russian Federation	A	2015-01-10
CN102458266B	China	B	2015-01-14
AU2010247959B2	Australia	B2	2015-01-22
AU2010247961B2	Australia	B2	2015-01-22
CN102458268B	China	B	2015-01-28
RU2544224C2	Russian Federation	C2	2015-03-10
EP2643285A4	European Patent Office (EPO)	A4	2015-03-18
US2015080919A1	United States of America	A1	2015-03-19
IL216272A	Israel	A	2015-04-30
RU2551934C2	Russian Federation	C2	2015-06-10
US9055945B2	United States of America	B2	2015-06-16
JP5734967B2	Japan	B2	2015-06-17
AU2011326107B2	Australia	B2	2015-08-06

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	Event	Code
2019-10-03	Grant or registrationFG	FG
2017-05-15	Transfer or rightsGB	GB
2017-05-15	Change of company name or juridical statusHC	HC