SURGICAL FASTENER AND APPARATUS

Abstract

A surgical fastener having a first part and a second part, each of the first and second parts comprising a clamping bar and a centrally-positioned perpendicular bracing bar extending therefrom, the clamping bar and bracing bar together defining a T-shape, wherein the surgical fastener further comprises at least one bracing element connecting the bracing bar of each of the first and second parts. A surgical apparatus for the application of a fastener to tissue comprising a handle assembly, a shaft extending distally from the handle assembly, a drive assembly, an articulation assembly and a jaw assembly mounted adjacent a distal end of the shaft comprising fixed support jaw and a clamping jaw, at least one of the jaws comprises a rotatable fastener support defining a T-shaped recess therein for receiving a surgical fastener, wherein the articulation assembly is operable to rotate the fastener support and the drive assembly is operable by the handle assembly to move the clamping jaw in and out of a closed configuration with respect to the support jaw.

Claims

1. A surgical fastener having a first part and a second part, each of the first and second parts comprising a clamping bar and a centrally-positioned perpendicular bracing bar extending therefrom, the clamping bar being elongate relative to the bracing bar; the clamping bar and bracing bar together defining a T-shape, wherein the surgical fastener further comprises at least one bracing element connecting the bracing bar of each of the first and second parts and wherein the surgical fastener is, as a whole, elongate.

2. The surgical fastener of claim 1, wherein first and second parts are substantially identical.

3. The surgical fastener of claim 1 or claim 2, wherein there is a plurality of bracings bars associated with each clamping bar, preferably wherein there are three bracing bars evenly spaced along each clamping bar of either or both the first and second parts and more preferably a bracing element connecting the bracing bars of the first and second parts.

4. The surgical fastener of any preceding claim, wherein the at least one bracing element is curved.

5. The surgical fastener of any preceding claim, wherein the bracing element comprises a plurality of elements to create a multi-part bracing element.

6. The surgical fastener of any preceding claim, wherein the bracing bar is made of a material which has a greater rigidity relative to material used for forming the at least one bracing element.

7. The surgical fastener of any preceding claim, wherein the surgical fastener further comprises a reinforcement feature, preferably wherein the reinforcement feature is a reinforcement or stiffening flange

8. The surgical fastener of any preceding claim wherein the tissue contacting edges of elongate bar, bracing bar and/or reinforcement feature are curved and/or blunt.

9. The surgical fastener of any preceding claim wherein, the bracing bar comprises a mating element for operatively engaging with a corresponding element on a fastener applicator.

10. A kit comprising a plurality of the surgical fastener as defined by one or more of the preceding claims.

11. A surgical apparatus for the application of a fastener to tissue comprising: a handle assembly; a shaft extending distally from the handle assembly; a drive assembly; an articulation assembly; and a jaw assembly mounted adjacent a distal end of the shaft comprising fixed support jaw and a clamping jaw, at least one of the jaws comprises a rotatable fastener support defining a T-shaped recess therein for receiving a surgical fastener, wherein the articulation assembly is operable to rotate the fastener support and the drive assembly is operable by the handle assembly to move the clamping jaw in and out of a closed configuration with respect to the support jaw.

12. The surgical apparatus of claim 11, wherein the fastener support(s) is generally annular, preferably with one flattened edge.

13. The surgical apparatus of claim 11 or 12, wherein both the support arm and clamping arm comprise a rotatable fastener support defining a T-shaped recess therein for receiving a surgical fastener.

14. The surgical apparatus of claims 11 to 13 wherein, the articulation assembly comprises a pulley system including a groove formed in the one or more fastener supports and corresponding antagonistic tendons operatively associated with the handle assembly via the shaft, preferably wherein the groove is annular and/or the pulley system is spring is loaded to retain tension in tendons.

15. The surgical apparatus of any preceding claim, wherein the handle assembly comprises a thumb wheel, dial, button or interface for operating the articulation assembly.

16. A surgical apparatus for the application of a fastener to tissue comprising: a handle assembly; a shaft extending distally from the handle assembly; a drive assembly; an articulation assembly; and a jaw assembly mounted adjacent a distal end of the shaft comprising fixed support jaw and a clamping jaw, at least one of the jaws comprising a fastener engaging member for rotating the fastener wherein the articulation assembly is operable to rotate the fastener and the drive assembly is operable to move the clamping jaw in and out of a closed configuration with respect to the support jaw.

17. The surgical apparatus of claim 16, wherein at least one jaw comprises a fastener support for releasably securing a surgical fastener thereto.

18. A surgical apparatus for the application of a fastener to tissue comprising: a handle assembly; a shaft extending distally from the handle assembly; a drive assembly; and a jaw assembly mounted adjacent a distal end of the shaft comprising fixed support jaw and a clamping jaw, at least one of the jaws comprising fastener support defining a T-shaped recess therein for receiving a surgical fastener therein, wherein the drive assembly is operable by the handle assembly to move the clamping jaw in and out of a closed configuration with respect to the support jaw.

Description

BRIEF DESCRIPTION

[0048] Various features, embodiments and examples of the presently disclosed surgical fastener and fastener applying apparatus will now be described herein with reference to the accompanying figures wherein:

[0049] FIG. 1a is a perspective view of an unclamped ductile fastener of the prior art;

[0050] FIG. 1b is a perspective view of a clamped ductile fastener of the prior art;

[0051] FIG. 2 is a perspective view of a surgical fastener applier of the prior art;

[0052] FIG. 3a is a is a top view of one embodiment of the T-shaped fastener of the invention;

[0053] FIG. 3b shows side views of one embodiment of the T-shaped fastener of the invention;

[0054] FIG. 3c is a perspective view of alternative embodiments of the T-shaped fastener of the invention;

[0055] FIG. 3d is a perspective view of yet further alternative embodiments of the T-shaped fastener of the invention;

[0056] FIG. 4 is a view of the T-shaped fastener having been pressed out during manufacture and prior to final formation for use;

[0057] FIG. 5 is a perspective view of a further embodiment in which the T-shaped fastener of the invention which has a multi-bracing;

[0058] FIG. 6 is a perspective view of a further embodiment of the T-shaped fastener of the invention;

[0059] FIG. 7 is a perspective view of yet a further embodiment of the T-shaped fastener of the invention;

[0060] FIG. 8 provides perspective views of a distal end of an embodiment surgical fastener applier in use;

[0061] FIG. 9 provides perspective views of the jaw assembly of the surgical apparatus of FIG. 8;

[0062] FIG. 10 provides a side view of the jaw assembly of the surgical apparatus of FIG. 8;

[0063] FIG. 11 provides a top view of part of the internal articulation assembly according to an embodiment of the surgical fastener applier;

[0064] FIG. 12 provides a side view of a surgical fastener applier according to an embodiment of invention;

[0065] FIG. 13 provides internal side and perspective views of the components of a handle assembly of the surgical fastener applier in accordance with an embodiment of the invention;

[0066] FIG. 14 provides an internal perspective view of the handle assembly and articulation mechanism assembly of the surgical fastener as shown in FIG. 13.

DETAILED DESCRIPTION

[0067] As used herein, the term proximal refers to the end of the apparatus or feature which is closer to the user or clinician and the term distal refers to the end of the apparatus which is further away from the user.

[0068] FIG. 1a is a perspective view of a plurality of unclamped ductile fasteners of the prior art. Such fasteners generally each comprise a single U-shaped body, which extends either side of the tissue to be clamped. As can be seen in perspective view FIG. 1b, the fasteners of the prior art are in a clamped configuration wherein an uneven pressure is provided along the upper and lower surfaces of the staple line, creating a dimpling effect and resulting in pockets through which blood may leak.

[0069] FIG. 2 is a perspective view of a surgical fastener applier of the prior art comprising a proximal handle, shaft and clamping end effector at a distal end of the shaft, the end effector comprising jaws for receiving and clamping a clip, wherein the jaws are operably linked to the handle. The user operates the handle to drive the jaws together moving the legs of the clip toward one another into a closed configuration around the tissue. The whole shaft may be rotated by the user by twisting a standard annular grip which surrounds the shaft adjacent the handle.

[0070] Embodiments of the surgical fastener and surgical fastener applying apparatus in accordance with the present invention will now be described in detail with reference to the drawings.

[0071] Referring now to FIGS. 3a, 3b and 3c and 3d, a surgical fastener or clip 1 generally has a first part 2 and a second part 3, each of the first and second parts comprising an elongate clamping bar 4, which may be a flattened plank. In the same plane, for each clamping bar there extends a bracing bar 5, 5a, 5b, which extends perpendicularly to the elongate clamping bar and is typically centrally positioned along its length.

[0072] From a top view in FIG. 3a it can be clearly seen that clamping bar 4 and bracing bar 5 together define a distinctive T-shape.

[0073] It can be seen in FIGS. 3a-d that the fastener further comprises at least one bracing element 6 which joins the first and second parts 2, 3 of the fastener via their respective ends of the bracing bars 5a, 5b. In particular, the bracing element 6 of the fastener may be integrally moulded to form a humped curve defining multi-section element, as shown in FIGS. 3b, c and d.

[0074] The construction of the fastener functioning as a T-shaped clamp is fundamental to providing balanced distribution of pressure on to the tissue when clamping the tissue during surgery. It also enables clamping over a sufficiently large surface area to reduce the likelihood that the fastener will move or slip in a lateral or longitudinal direction along the tissue. Further, in embodiments where the fastener has identical first and second parts 2 and 3 this further ensures an even distribution of pressure when clamping tissue there between.

[0075] Further, by virtue of first and second parts having an elongate clamping bar 4 a longer portion of tissue extending along the staple line can be clamped with even pressure, minimising the number of fasteners required and shortening the time needed to effectively minimise bleeding at the staple line.

[0076] As can be seen in FIGS. 3a, c and d the external edges 7 of the elongate members of both first and second parts 2, 3 are either curved and/or blunt to ensure the risk of perforation of the tissue is minimised when the fastener is clamped. Furthermore, for the same reason, the internal edges 7a either side of the bracing bars 5a and 5b joining the internal edge 7a of the clamping bar 4 of first and second parts 2, 3 may also be curved and or smooth.

[0077] The clamping bar may be sized such that the particular fastener is useful for certain surgical applications. FIG. 3c shows alternative fasteners in which the width of the clamping bar and/or bracing bar is increased or reduced in accordance with such applications.

[0078] It is not essential that the clamping bar is elongate. Where the clamping bar is not elongate it is preferred that the size of the clamping bar is defined by the maximum width of the applicator by which it is inserted and deployed; such an example is described in use with one form of the apparatus further below. Essentially, a constant and balanced pressure can be obtained when the fastener of this definition clamps a section of tissue together. A non-elongate embodiment is shown in FIG. 3d as compared to elongate examples wherein the clamping bar is elongate and the length of the overall fastener has been increased. Additionally the depth or thickness of the whole fastener may be increased dependent of the particular surgical application (also shown in FIG. 3d). An embodiment with increased thickness permits the fastener to be further shaped during construction to remove any sharp edges its final form, preventing completely the possibility of sharp edges contacting the tissue surface during use.

[0079] FIG. 5 shows a further example of the invention in which each fastener has three bracing elements 6a, 6b, 6c, wherein first and second parts 2, 3 each have a clamping bar 4 with three corresponding bracing bars 8a, 5a, 9a and 8b, 5b, 9b, respectively. This arrangement of multiple bracings allows for a greater degree of clamping force to be exerted evenly across the tissue and would further prevent the fastener from slipping and occurrence of leakage along the staple line.

[0080] In an alternative embodiment of the fastener, such as the arrangement shown in FIG. 6, there may be a recess 10a, 10b machined in to the bracing bar of one or both of the first and second parts 2, 3.

[0081] One recess 10b assists the fastener to be releasably retained in the jaw of a fastener applying apparatus during loading and transfer of the fastener to the surgical site, for example, by engaging with a corresponding retaining feature positioned in the jaw. The other recess 10a may assist rotation of the fastener by, for example, co-operating with or engaging a corresponding mating feature positioned in a jaw of the fastener applying apparatus which is operable to rotate the fastener.

[0082] Embodiments of the invention may comprise one or both recesses. The fastener may be easily released at the surgical site since the clamping action by the fastener applying apparatus compresses the first and second parts together, thereby moving one or both recesses out of registration with the retaining feature or mating feature on the respective jaws of the apparatus.

[0083] FIG. 7 shows a perspective view of a clamped and unclamped embodiment of the fastener of the invention with, for example, the recesses described above in FIG. 4. In addition the fastener may further comprise reinforcement flanges or stiffening ledges or the like 11a, 11b, formed from the outer edge of the respective clamping bars 4 and running the length of the clamping bar.

[0084] Reinforcement of the clamping bar may assist in preventing potential deformation to the peripheral or far ends of the clamping bars of the fastener after clamping. The flanges 11a, 11b extend in opposing directions each perpendicular to their respective clamping bars. The flanges may be formed integrally with the clamping bars each forming a smooth curved surface area together with the clamping bars such that no edges of the clamping bars dig in to tissue when pressure is applied as they are clamped together. In particular, the edges of elongate bars, bracing bars and/or reinforcement features are curved and/or blunt. It is important that no feature of the fastener inherently or otherwise promotes ripping or cutting of the tissue or puts greater pressure on any part of the tissue which may result in tearing or otherwise cause bleeding.

[0085] Further as can be seen labelled in the clamped orientation of the fastener, additionally or alternatively to the reinforcement feature, there may include a groove 12 etched between the flanges and the clamping bars allowing the load applied to the fastener to be concentrated to an area which promotes desirable bending of the fastener with reduced force.

[0086] These reinforcement features allow the fastener to be clamped and retained on the tissue in a more reliable manner than achieved by conventional fasteners; the fastener deforms in a controlled manner and ensures that the fastener remains parallel with the staple line of the tissue while it is under load and deforms there around.

[0087] The additional reinforcement features of this example may be provided with or without recesses in preferred embodiments.

[0088] The parts of the fastener described herein above are typically formed integrally i.e. formed as a whole. The fastener of the invention may be manufactured by forming a shape as disclosed in any of the herein described figures.

[0089] Accordingly, the fastener may first be stamped, forged, moulded, or machined into a first desired shape, for example as shown in FIG. 4, from a ductile material or metal, such as Titanium, for example, ASTM F67 grade 1. The material must be able to deform without returning to its original shape or fracturing under pressure. However, the fastener may be formed from other materials suitable for use in surgery such as alloys, steel, metal, other grades of titanium, or other biocompatible or suitable implantable material.

[0090] Different parts of the fastener may be made from different materials to impart certain characteristics to the fastener. For example, the bracing bar can be made of a material which has a greater rigidity relative to metal used for forming the bracing element. This allows the fastener to deform in a more predictable and reliable manner.

[0091] To form the fastener into a shape ready for loading, the fastener is treated in accordance with typical annealing methods known in the art. The fastener may be heated in a vacuum. Thereafter, once the fastener is bent or folded into its form it may be cooled slowly, in accordance with typical techniques known in the art. Such steps may be varied in accordance with known heat treatment and cooling processes in order to stress relieve and change the fastener hardness and strength of the final fastener.

[0092] Variations of the presently disclosed fastener shapes are possible and within the scope of the present disclosure provided the major features of the invention are present, as defined by the claims.

[0093] Description of loading and applying various fasteners using different versions of apparatus, as required, will now be described below;

[0094] FIG. 8 shows the distal end portion of the apparatus of the invention for applying T-shaped fasteners.

[0095] The apparatus comprises general features typically well known in the art including a proximal end portion (not shown) comprising a handle assembly with a grip and a lever operable to close jaws of the apparatus. The apparatus further comprises an outer body and longitudinal axis defined there along (not shown). The outer body is an elongated shaft which extends between the proximal end and the distal end of the apparatus and includes an axial passage there between. The shaft and handle may be made from a variety of rigid biocompatible materials, such as stainless steel, a plastic such as acrylonitrile-butadiene-styrene (ABS), a polycarbonate material or any other biocompatible material capable of the requirements described herein. In a preferred embodiment, the shaft is rigid; however it may also be made from a semi-compliant or flexible material to allow some flexibility along the axis. The shaft is tubular and has a relatively small outer diameter for insertion into and through a trocar cannula or other small incision. The outer diameter of the shaft is limited in size by the inner diameter of the trocar through which it must pass to access the surgical site.

[0096] The distal end of the apparatus comprises a two jaw assembly mounted adjacent a distal end of the shaft comprising fixed support jaw and a clamping jaw 14a, 14b. A drive assembly is operable by the handle assembly to move the clamping jaw in and out of a closed configuration with respect to the support jaw by methods known well to those skilled in the art. This is typically achieved through an elastically deflecting clamping jaw and an inclined plane mechanism. The elastically deflecting clamping jaw has an inclined feature 30 so that when a sliding component 32 traverses across, a force is imparted perpendicular to the plane, so as to cause deflection of the cantilevered jaw 14b.

[0097] Any other mechanical means of rotating the clip in the jaw would have to compensate for the deflection of the jaw in a dual clamping jaw; hence, it is practical to have a fixed jaw and a moving/clamping jaw.

[0098] In the example, the fixed jaw further includes a rotatable fastener support 15a comprising a T-shaped recess 16 for receiving a fastener 1 having a corresponding configuration therein. Each fastener support is generally annular in shape but may have one flattened side 15s to facilitate its enclosure within the assembly as a whole and support and manoeuvre the fastener more securely.

[0099] In FIG. 8 the apparatus is shown in a non-rotated position in which an elongate T-shaped fastener has been inserted into the T-shaped recess 16 of the fastener support 15a and orientated longitudinally therewith.

[0100] As can be seen in FIG. 9, the rotatable fastener support may further comprise an annular groove 17.

[0101] The apparatus also comprises an articulation assembly which includes a pulley system comprising antagonistic tendon 18 arranged about the annular groove 17 of a pulley 33 associated with the rotatable fastener support. The articulation assembly operates to rotate the fastener support as shown in FIG. 11.

[0102] The antagonistic tendon may be attached to an actuating mechanism using any of a variety of methods available and known to those of skill in the art. As an example, the proximal end of a tendon may be attached to the actuating mechanism which in turn is operably linked by manipulating a thumb wheel 40 as shown in FIGS. 11-14. Alternatively, this could be any rotatable feature such as dial, button or the like on the handle assembly which is operable to move antagonistic tendons 18 and rotate the fastener support

[0103] In FIGS. 11-14 the fastener support is rotated by an antagonistic tendon system whereby the tendons 18 are terminated at the pulley through a ferrule or using a grub screw or a plastically deformable feature that grips the tendon to prevent slippage when tension is applied, and thus apply torque to the pulley. The tendons may run through a low friction sleeve 45, such as in a Bowden cable arrangement, or be passed through a low friction bearing surface within the shaft of the instrument.

[0104] In an alternative design, there is only a single pull tendon and a spring is used to return the pulley to the 0 position. However, other methods may be used to articulate the fastener support in order to rotate the fastener from an orientation in which it is longitudinally aligned with apparatus to a second orientation where it has been rotated from 10 to approximately 90 degrees.

[0105] Once the fastener support and thus fastener within has been rotated by the desired amount a drive assembly is operable by the handle assembly to move the clamping jaw in and out of a closed configuration with respect to the support jaw by methods known well to those skilled in the art.

[0106] FIG. 12 shows an embodiment of the apparatus utilised to retain, insert, rotate and clamp a fastener in vivo. The apparatus comprises general features typically well known in the art for clamping a fastener including a proximal end portion comprising a handle assembly with a grip 50 and a lever 52 operable to close jaws of the apparatus. The apparatus further comprises an outer body and longitudinal axis defined there along. The outer body is an elongated shaft 19 which extends between the proximal end and the distal end of the apparatus and includes an axial passage there between. The shaft is tubular and has a relatively small outer diameter for insertion into and through a trocar cannula or other small incision. The outer diameter of the shaft is limited in size by the inner diameter of the trocar through which it must pass to access the surgical site. The whole shaft may also be rotated by the user by twisting a standard annular grip which surrounds the shaft adjacent the handle.

[0107] As shown in FIGS. 13 and 14 the proximal end of the apparatus comprises a trigger or lever linkage 55 to translate movement when the user pulls the lever towards the grip 50 in order to drive the clamping jaw towards the fixed jaw. The drive assembly may further include a return springe 57 to urge the lever back to its original position after being operated by the user.

[0108] In some embodiments, where the T-shaped fastener is not elongate (e.g. see the smallest of fasteners in FIG. 3d), a rotation mechanism is unnecessary and therefore the invention extends to embodiments in which no articulation mechanism for rotation is required.

[0109] However, in preferred embodiments an elongate T-shaped fastener of the invention is utilised with said apparatus and therefore an embodiment of the apparatus which may easily insert the elongate fastener and has the function to rotate said fastener once in vivo has multiple benefits in surgery, as explained previously.

[0110] In other embodiments, instead of a T-shaped recess and rotatable support, the fixed jaw has a fastener engaging member for rotating the fastener wherein the articulation assembly is operable to rotate the fastener via the engaging member (and the drive assembly is operable to move the clamping jaw in and out of a closed configuration with respect to the support jaw). It is envisaged that such an embodiment would be utilised with a fastener as shown, for example, in FIG. 6 or 7 where the fastener has a corresponding means, such as a recess, to engage, at least temporarily with the surgical applier.