Apparatus for surgical fastening

ES 2 355 852 T3

DESCRIPTION

Surgical fixation device

The invention relates to a surgical fastener.

Surgical fasteners are widely used in different medical procedures. For example, staples, sutures, clamps, and other fasteners are commonly used in laparoscopic and open surgical operations to secure two or more pieces of tissue, prosthesis, or other material together. The fixation elements can make it possible to obtain a permanent connection between two parts, such as between a bone and a nonabsorbable prosthesis, or they can allow to obtain a more provisional fixation, such as between a mesh prosthesis and a muscle or other tissue to allow tissue growth or other healing procedures more securely fix the mesh relative to the tissue.

For example, Jervis patent publication US 2004/0049227 describes a helical fixation element and applicator for fixing a prosthesis to tissue, e.g. For example, to fix a mesh prosthesis in a hernia repair operation. The applicator described in Jervis can apply one or more fasteners having the shape of a helical wire coil by means of a rotating element that rotates and discharges the fasteners from a distal end of the applicator. In one embodiment, a fixed stabilizer rod located in an inner portion of the coil fasteners has a thread shape that attaches to the fasteners and supplies the fasteners as they rotate.

In the patent publication US 2004/0204723, by Kayan, and in the patent publication US 2005/0171562 (on which the two-part structure of the attached claim 1 is based), by Criscuolo, among others, other fixation elements used to fix a mesh in a surgical operation, such as a hernia repair. In Kayan and Criscuolo, the fasteners include a thread form and a head with a screw-shaped structure. It is also stated that these fasteners are made of an absorbable material. Therefore, the fasteners can degrade and be absorbed by the body after the surgical operation is completed.

A surgical fixation element according to the invention is characterized in that the through hole includes a threaded part and the head part includes at least one actuating element adapted to be attached to a actuating device to rotate the cylinder part within a tissue. In one embodiment, the through hole may have an unthreaded portion located at a proximal end of the through hole. The threaded portion may be located at a distal end of the through hole and the unthreaded portion may extend approximately half the length of the through hole.

In one embodiment, the at least one actuator may include opposing flats on sides of the head portion.

The distal end of the cylinder part can be arranged at least partially in a plane transverse to the longitudinal axis. The head part may have a maximum width that is larger than the maximum width of the cylinder part. The through hole can extend along the longitudinal axis through the head part and the cylinder part. In one embodiment, the distal end of the barrel portion may have a face that is at an angle to the longitudinal axis.

Opposite sides of the head portion may have curved depressions adapted to join a rotatable member to rotate the fastener about the longitudinal axis during application.

These and other aspects of the invention will be apparent from the following description and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

Aspects of the invention will now be described, with reference to illustrative embodiments, in which equivalent reference numerals refer to equivalent elements, and in which:

FIG. 1 is a perspective view of a fastener applicator for applying a fastener according to the invention;

FIG. 2 is an end view of the distal end of the applicator of Fig. 1;

ES 2 355 852 T3 FIGS. 3-5 show a cross-sectional view of the distal end of the applicator at various stages of the application of a fastener;

FIG. 6 shows a side view of a fixing element according to aspects of the invention;

FIG. 7 shows a bottom perspective view of the fixing element of Fig. 6;

FIG. 8 shows a top perspective view of the fixing element of Fig. 6;

FIG. 9 shows a top view of the fixing element of Fig. 6;

FIG. 10 shows a cross-sectional view of the fixing element of Fig. 6;

FIG. 11 shows a cross-sectional view from the left side of the handle portion of the fastener applicator; and FIG. 12 shows a cross-sectional view from the right side of the handle portion of the fastener applicator.

DETAILED DESCRIPTION

It will be understood that aspects of the invention are described herein with reference to the figures, which show illustrative embodiments according to aspects of the invention. The illustrative embodiments described herein are not intended to necessarily show all aspects of the invention, but rather serve to describe a few illustrative embodiments. Therefore, aspects of the invention are not intended to be construed as limiting in light of illustrative embodiments. Furthermore, it will be understood that it is possible to use the aspects of the invention independently or in combination with other aspects of the invention.

A fastener application system for applying a fastener according to the invention may include a plurality of fastener elements each including a cylinder portion with an external thread and a through hole extending through the portion of the fastener. cylinder, p. eg, along the longitudinal axis of the cylinder. Each of the fastening elements may include a head portion that may be wider than the cylinder portion and / or the external thread of the cylinder. The fasteners may be arranged along a mandrel which has a threaded portion and extends through the through hole of the fasteners. At least a part of the through hole of each fastener may have an internally threaded part that is attached to the threaded part of the mandrel. A rotatable element, such as a tube extending over the fasteners, can be attached to the fasteners and rotate them, thereby displacing the fasteners along the mandrel. That is, the mandrel can be fixed and the rotatable fastening elements can advance along the mandrel thanks to the connection between the internal threaded part of the fastening elements and the threaded part of the mandrel.

The fastening system can be used to apply the fasteners to a specific tissue or other material, e.g. For example, to attach a mesh to muscle tissue in a hernia repair operation. To apply a fastener, first, it is possible to position a leading or distal end of the mandrel next to a specific material. In an illustrative embodiment, it is possible to insert the mandrel into the specific material, e.g. For example, it is possible to insert a pointed end of the mandrel into the specific material. The rotatable element can rotate at least one fastener located closest to the distal end of the mandrel, advancing the fastener distally along the mandrel and into the specific material. It is also possible to rotate other fasteners on the mandrel to supply the fasteners toward the distal end of the mandrel while engaging the most distally positioned fastener. While the most distally positioned fixation element rotates, the external thread of the fixation element barrel can bond with the specific material (e.g. mesh, tissue and / or others) and insert the fixation element into the material. A head arranged on the fastener can facilitate seating of the fastener on the surface of the material, facilitate the clamping of two or more materials together, and / or prevent excessive insertion of the fastener into the material.

FIG. 1 shows a fastener applicator 100 and associated fasteners in an illustrative embodiment. The applicator 100 includes a handle 1 and a shaft 2 that extends distally from the handle 1. The shaft 2 houses a rotatable element 3 and a plurality of fixation elements 4 arranged on a mandrel 5. A trigger or other actuator 6 located on the handle 1 can be actuated by a user to cause the rotating element 3 to rotate at least one clamping element 4 located in the most distal position with respect to the mandrel 5, thereby making a thread

ES 2 355 852 T3 internal of the clamping element 4 is joined to the threads of the mandrel 5 and displaces the clamping element 4 distally with respect to the mandrel 5. The actuation of the actuator 6 can also serve to move the mandrel 5 distally with respect to the rotary element 3 and / or axis 2, eg. eg, such that a pointed end of mandrel 5 protrudes from the distal end of shaft 2. Once the fastening element 4 located in the most distal position has been applied, the mandrel 5 can move back into the shaft

2.

The rotating element 3 may have any suitable shape to rotate the fixing elements 4 with respect to the mandrel 5. In this embodiment, the rotating element 3 is tubular in shape with an approximately oval cross section, as can be seen in FIG. 2. The flat surfaces 31 of the rotating element 3 can be joined to the corresponding surfaces of the fixing elements 4, eg. eg, the flat lateral surfaces of the heads of the fixing elements 4, while allowing the fixing elements 4 to move axially along the mandrel 5 with respect to the rotating element 3. The circular parts of the rotating element 3 they may be in tight contact with the inner surface of the shaft 2, e.g. eg, to help prevent rotating element 3 from shaking on axis 2 during rotation. However, it will be understood that the rotating element 3 may have any suitable arrangement. For example, the rotating element 3 may have a hexagonal, square, star-shaped or other cross-section for attachment to corresponding surfaces of the fixing elements 4. Additionally or alternatively, the rotating element 3 may have one or more ribs, curves, tabs, grooves or other elements that are attached to the fixing elements 4 to make them rotate. In other embodiments, the rotating element 3 need not have a tube-like structure, and it can be attached to the fixing elements in other ways. For example, the rotating element 3 may have one or more teeth extending longitudinally through the axis 2 and through corresponding holes or slots in the fixing elements 4. The rotation of the teeth around the mandrel 5 allows the fixing elements 4 to be rotated for their application. In another arrangement, the rotary member 3 may include a transmission that extends along one side of the axis 2. The transmission can partially extend into the interior space of the shaft 2 to come into contact with the fixing elements 4. The rotation of the transmission allows the fasteners (which may have complementary transmission teeth formed on their heads for attachment to the transmission) to rotate to engage the fasteners as described above. In other arrangements, the rotary element 3 can rotate only the fixation element 4 located in the most distal position and the rear fixation elements can be supplied forward by other means, such as a spring. For example, the mandrel 5 may include only a threaded portion near a distal end of the shaft. Other proximal parts of the mandrel 5 may have a smooth cylindrical surface or other arrangement that does not join the fasteners 4.

FIGS. 3-5 show a fastener being applied by the applicator 100 of FIG. 1. In FIG. 3, a user can position the distal end of the shaft 2 against a specific material, such as a mesh prosthesis 81 placed in a muscle tissue 82. At this time, the mandrel 5 and the fixation element 4 located in the most distal position they may be located within the axis 2 (although in other embodiments the mandrel 5 and / or the fastener 4 may be outside of it). Actuation of applicator 100 may initially extend mandrel 5 out of the distal end of shaft 2, such that mandrel 5 penetrates mesh 81 and / or tissue 82. In this embodiment, mandrel 5 has a sharp point to assist to pierce the specific material, although other arrangements are possible, such as an auger-shaped element, a conical tip, a blunt end, or other elements at the distal end of the mandrel. Alternatively, the mandrel 5 may not penetrate the specific material, but only press against the material or be positioned adjacent to the material, e.g. eg, in embodiments where the mandrel 5 does not extend distally from axis 2. Also in this embodiment, the mandrel 5 extends into the specific material without rotating, although in some embodiments the mandrel 5 may rotate while piercing the material specific, p. For example, to facilitate entry into the material. During the distal extension of the mandrel 5, the rotary element 3 can remain fixed, so that the fixation elements 4, which are attached to the threads of the mandrel 5, slide distally with the mandrel 5 with respect to the rotary element 3 while the mandrel 5 is extended. (It will be understood that the exit of the mandrel 5 from the distal end of the shaft 2 may occur by proximally retracting the distal end of the shaft 2 and / or the rotary element 3, e.g., when the distal end of the shaft is pressed against the shaft. material, in addition to, or instead of, distally displacing the mandrel 5).

With the mandrel 5 extended into the material, as shown in FIG. 4, the rotary element 3 can rotate around the mandrel 5. This causes the clamping elements 4 to rotate relative to the mandrel 5 (which remains rotatably fixed) and distally travels along the threads of the mandrel. When the distal tip of the fixation element 4 located in the most distal position leaves the axis 2, the fixation element 4 penetrates the mesh 81 and the tissue 82. In addition to the connection by

ES 2 355 852 T3 screwing between the fixation element 4 and the mandrel 5, which forces the fixation element 4 to move distally when the rotating element 3 rotates, the external thread of the fixation element 4 can join the mesh 81 and the tissue 82 and assist in inserting the fastener into the material. With proper rotation of the fastener 4, the fastener 4 is fully inserted into the material, as shown in FIG. 5. In this embodiment, a proximal part of the through hole of the fixing elements 4 is not attached to the threaded part of the mandrel 5, e.g. For example, only the distal portion of the through hole is internally threaded, with the proximal portion having a smooth cylindrical shape or other configuration that does not engage the threads of the mandrel. Accordingly, the fixing element 4 can be separated from the mandrel 5, and the mandrel 5, the rotating element 3 and the shaft 2 can be separated from the tack to apply the fixing element 4 from the applicator 100. The mandrel 5 can back into axis 2, to the position shown in FIG. 3, ready to apply the next applicator fastener 100.

The fasteners 4 used with the applicator 100 may have any suitable arrangement, as will be understood by those skilled in the art. FIGS. 6-10 show various views of a fastener 4 in an illustrative embodiment. FIG. 6 shows a side view of the fixing element 4, which has a head 41, an external helical thread 42 and a cylinder part 43. Head 41 can be of any suitable size and / or shape and, in this embodiment, has a relatively flat distal face adjacent to thread 42 and a rounded proximal face. External thread 42 may have a diameter d that is similar in size to head 41 in the view shown in FIG. 6. External thread 42 may comprise approximately 3½ turns around cylinder portion 43, although in other embodiments thread 42 may comprise fewer or more turns. External thread 42 may also taper near the distal end of barrel portion 43. This taper can help the fastener to penetrate a specific material, such as mesh 81. In this embodiment, the thread 42 does not taper at the proximal end of the barrel portion 43, but rather maintains a relatively constant diameter. to a point where thread 42 meets head 41. In other embodiments, thread 42 can taper, e.g. eg, until reaching zero height, at the head 41 or before reaching it. The fact that the thread 42 extends to the head 41 can help to allow the fastener 4 to be removed from a material, such as mesh 81, simply by rotating the fastener 4 in the reverse direction. On the other hand, it is possible that such a thread arrangement allows the fastener 4 to be "pushed in excessively" and pass through a mesh 81 or other material to an undesired depth. The fact of having a free space between the most proximal end of the thread 42 and the head 41 can facilitate the arrest of the introduction of the fixation element in the surface of a material and can also cause some materials, such as a mesh 81 , are trapped between thread 42 and head 41. Other variations on external thread 42 are possible, such as different thread pitches, variable thread pitch, different thread face angles (front or back faces), different thread tip shapes (pointed, flat , as shown, rounded, etc.), two or more threads, etc. In external thread 42, the most distal portion of thread 42 may also extend forward relative to cylinder portion 43, e.g. eg, by forming an auger, hook or tooth part that can facilitate the introduction of the fixing element 4 into a material. In summary, it is possible to use any suitable external thread arrangement 42 in some aspects of the invention.

In one aspect of the invention, the cylinder portion may have a sloping elliptical front face 431 or leading edge. For example, as shown in FIG. 6, the barrel portion 43 may have a sloped distal end. If the cylinder part 43 has a cylindrical or conical shape, the sloping distal end may be an elliptical leading edge present on the cylinder part 43. This arrangement can facilitate the penetration of the fastener 4 into a material, e.g. eg, because only a leading portion of the distal end of cylinder portion 43 penetrates the material first, opening the way for the rear of the distal end. Other arrangements are possible for the distal end of the tack, including a "fish mouth" type element, in which the distal end of the barrel portion 43 has a "V" shaped notch. Alternatively, the distal end of the barrel portion 43 may have a sharp leading edge to facilitate penetration into the material.

FIGS. 7 and 8 show upper and lower perspective views of the fixing element 4. In this embodiment, the head 41 of the fastener 4 includes opposite flat side surfaces 411 that meet the flat surfaces 31 of the rotatable member 3. In addition, the thread 42 includes a flat portion 421 that can come into contact with the surfaces 31. of the rotating element 3, p. eg, to help stabilize the fixing element 4 on the rotating element 3. The flat portion 421 can also help to maximize the height of the thread 42, while keeping the diameter d of the thread 42 less than the distance between the side surfaces 411 of the head 41, e.g. eg, to allow fastener 4 to fit within rotatable member 3. Head 41 may also include curved depressions 412 on opposite sides of head 41. These curved depressions 412 can

ES 2 355 852 T3 facilitate correct alignment of a plurality of fastener elements 4 when mounting fastener elements 4 for loading into a system 100. The depressions 412 may have the same size and / or shape, or may be different to aid to ensure that all fasteners 4 loaded into a system are similarly aligned. The alignment of the fixing elements 4 can be important, for example, when the fixing elements 4 have a non-symmetrical shape, e.g. eg, when they include a sloped distal face as shown in FIG. 6. The depressions 412 may also serve to reduce the contact surface between the fixing elements 4 and the rotating element 3, thereby potentially reducing friction that would resist sliding movement of the fixing elements 4 on the rotating element 3. The FIG. 9 shows a top view of the fixing element 4, in addition to the curved depressions 412 and the side surfaces 411.

In another aspect of the invention, the fasteners may have a through hole 44 that extends through the cylinder portion 43 and the head 41. The through hole 44 may extend along a longitudinal axis of the portion 43 cylinder and, as can be seen in FIG. 9, forms a passage through the fixing element 4. In one aspect of the invention, a through hole portion 44 may have an internally threaded portion 441, e.g. eg, in a distal portion of through hole 44, as shown in the cross-sectional view of the fastener of FIG. 10. A proximal portion 442 of the through hole may have a larger diameter than threaded portion 441, e.g. eg, so that proximal portion 442 does not bond with mandrel 5. Proximal portion 442 can be of any shape or size, eg. For example, it may have a smooth cylindrical shaped hole. By arranging the through hole 44 so that only a distal portion of the fixation element 4 is attached to the mandrel 5, the fixation element 4 can more easily be separated from the mandrel 5 during application. However, the through hole 44 may be threaded along its entire length, or it may be threaded only at the proximal end. In this case, if desired, the mandrel 5 may not be threaded at its distal end. The pitch of the internally threaded portion 441 may be the same, longer, or shorter than the pitch of the external thread 42. In this illustrative embodiment, the pitch of the internally threaded portion 441 is shorter than the pitch of the thread. external thread 42, p. For example, to facilitate the separation of the fixing elements 4 from the mandrel 5 during their application. That is, the longer thread pitch of the external thread 42 can help to extract the fixing element 4 from the mandrel 5 when the fixing element 4 is inserted into a material.

The fastener may be made of any suitable biocompatible material, such as an absorbable material (eg, PLA or others), a nonabsorbable metal or plastic (eg, titanium), or any other material or combination of materials. Furthermore, the fixing elements 4 can be made in any suitable size, eg. e.g. with a length of approximately 6.35 mm (¼ inch) and a diameter of approximately 3.17 mm (1/8 inch), with a through hole diameter of approximately 0.79 mm (1/32 inch) .

Applicator 100 can apply fasteners 4 using a manually operated mechanism, a motorized mechanism, or a combination of manual and motorized. FIGS. 11 and 12 show left and right side views, respectively, of a manually actuated mechanism for the applicator 100 of FIG. 1. In this illustrative embodiment, the handle 1 includes a trigger 6 having two operable trigger levers 61 and 62 that both pivot about a trigger pivot point 63. The outer trigger lever 61 is accessible and held by the user, while the inner trigger lever 62 is housed within the outer trigger lever 61. Both trigger levers 61 and 62 are forced to a home position, shown in FIG. 11, by a spring 64 or other suitable elastic element. The outer trigger lever 61 includes a chuck drive rack 611 having teeth that mesh with a chuck drive pinion 11. Accordingly, when the outer trigger lever 61 is moved towards the handle 1, the chuck drive rack 611 rotates the chuck drive pinion 11 (counterclockwise, as shown in FIG. 11 ). This rotates a chuck drive cam 111 which is attached to pinion 11 and is attached to a shaft 121 of a chuck slide 12. When the outer trigger lever 61 is in the home position, a notch 112 of the chuck drive cam 111 is attached to the shaft 121, allowing the chuck slide 12 to move proximally (to the right in FIG. 11) being diverted by a spring 13. However, when the outer trigger lever 61 is squeezed and the chuck drive cam 111 rotates, the cam 111 pushes the shaft 121 distally, causing the chuck slide 12 to move distally against the bias of the spring 13. Due to As the mandrel slide 12 is connected to the mandrel 5, the mandrel 5 moves distally with the mandrel slide 12. Chuck slide 12 only moves distally until notch 112 has passed shaft 121. Then the chuck slide 12 and chuck 5 remain fixed.

During initial movement of the outer trigger lever 61 from the home position, the inner trigger lever 62 remains stationary. However, as the outer trigger lever 61 continues to be squeezed, the outer trigger lever 61 contacts the inner trigger lever 62 so that 6

ES 2 355 852 T3 the inner trigger lever 62 also rotates about the trigger pivot point 63. The inner trigger lever 62 includes a rotary element drive rack 622 that meshes with a rotary element drive pinion 14 (see FIG. 12). Therefore, the displacement of the inner trigger lever 62 causes the rotation of the rotating element drive pinion 14 and an associated bevel gear 141, which meshes with a complementary bevel gear of a clutch.

fifteen. Consequently, the rotation of the rotating element drive pinion 14 causes the bevel gear 141 to rotate the clutch 15 (eg, clockwise, looking from the handle 1 towards the shaft

2). The clutch 15 is connected to the rotating element 3 and therefore turning the clutch 15 in a clockwise direction causes the rotating element 3 to also rotate in a clockwise direction. Further squeezing of the trigger levers 61 and 62 rotates the rotary element 3 and causes a fixing element 4 to be applied as described above. A pawl 16 is arranged to engage with the chuck drive rack 611 such that, when rotation of the fastener is initiated (i.e., once the outer trigger 61 contacts the inner trigger 62 and the clutch 15 rotates rotating element 3), trigger levers 61 and 62 cannot return to the starting position of FIG. 11 until the trigger levers 61 and 62 are released fully. By fully releasing trigger levers 61, 62, pawl 16 can release chuck drive rack 611, allowing chuck drive rack 611 and trigger levers 61 and 62 to return to the home position. . The return movement of the trigger levers 61 and 62 can cause the chuck drive pinion 11 and the rotary element drive pinion 14 to be reversely driven. Consequently, notch 112 reattaches to shaft 121, causing mandrel slide 12 and mandrel 5 to be displaced proximally by spring 13. Although bevel gear 141 may reverse rotate during trigger return, clutch 15 can prevent the rotating element 3 from rotating. In this way, the rotating element 3 remains fixed during the return of the trigger.

The application of the fastening element 4 located in the most distal position can occur during the travel of the trigger levers 61 and 62, that is, before the trigger levers 61 and 62 are fully depressed and the pawl 16 clears the lever. chuck drive rack 611. This arrangement can make it possible to ensure that the fixing element 4 is separated from the mandrel 5 before the rotation of the rotary element 3 stops and the mandrel 5 retracts. For example, the fixing element 4 may be arranged to separate from the mandrel 5 after the rotating element 3 makes three turns. However, the rotating member 3 may be arranged to rotate 3½ turns before stopping. After the rotary member 3 stops rotating, the pawl 16 may be arranged so that the trigger levers 61 and 62 need to be tightened further before the pawl 16 releases the rack 611. During this movement of the trigger levers 61 and 62, it is possible to perform other functions, such as actuation of a counter to indicate that a fastener has been applied. In one embodiment, it is possible to arrange on the handle 1 a screen showing the applied fasteners and / or the remaining fasteners, e.g. eg on an LCD or LED screen.

Therefore, having described various aspects of at least one embodiment of this invention, it will be understood that it will be apparent to those skilled in the art to carry out various alterations, modifications and improvements within the scope of the invention, defined in the following claims .