SURGICAL STAPLE HAVING TWO MOVABLE ARMS CONNECTED BY A TRANSVERSE CONNECTION AREA

Abstract

A surgical staple has two movable arms connected by a transverse connection area. Each one of the arms has a pinching area and a fastening end and the transverse connection area is deformable to allow the movable arms to be moved together by bending around the axis of the transverse connection area.

Claims

1. A surgical staple comprising two movable arms connected by a transverse connection area, each of said arms having a gripping area and an attachment end, and said transverse connection area being deformable so as to enable said movable arms to be brought together by folding about an axis of said transverse connection area.

2. A surgical staple according to claim 1, wherein said attachment ends are pointed so as to allow superficial penetration in the tissues to be brought together.

3. A surgical staple according to claim 1, wherein each of said attachment gripping areas has a flat, and said two gripping surfaces of said flats are semi-cylindrical.

4. A surgical staple according to claim 1, wherein said arms are arched.

5. A surgical staple according to claim 1, wherein said two arms are aligned before positioning and connected by a transverse connection area in a general form of a C, symmetrical with respect to a midplane of said staple.

6. A surgical staple according to claim 5, wherein said transverse connection area has, on either side of said midplane, an arched portion extending over an angle of between 70 and 85 extended by a second arched portion with an angle of curvature in the opposite direction extending over approximately 180, said arched portion being itself extended by a third portion perpendicular, before deformation, to a symmetry plane, said third portion having a bifurcation extended by a hook forming said gripping area on the one hand and by a second hook forming an attachment area, said two hooks being curved towards an inside of said staple.

7. A surgical staple according to claim 4, wherein said transverse connection area has a semi-tubular form and in that said arms are movable, by deformation of said transverse connection area, between a rest position in which they are coplanar and opposed symmetrically with respect to a midplane passing through an axis of said semi-tubular transverse area, and a position in which they are folded towards each other.

8. A surgical staple according to claim 7, wherein each of said arms has a pointed attachment end forming a pointed hook extending in front of a plane comprising the arm and said axis of said semi-tubular transverse area.

9. A surgical staple according to claim 8, wherein a tangent of said pointed attachment end forms an angle of between 0 and 70 with respect to a normal to a plane comprising said arm and said axis of said transverse area.

10. A surgical staple according claim 1, wherein each of said arms has a shoulder defining a gripping surface configured so that said gripping surfaces come into contact with external surfaces of a tissue area to be fixed, when said staple is closed.

11. A surgical staple according to claim 10, wherein said shoulder is formed by an elastically deformable arched lug, one end of which is connected to one of said arms and the other end forming said gripping surface.

12. A surgical staple according to claim 1, wherein each of said arms has a forked end, formed by an attachment end and a curved lug having a gripping surface, said arms being able to move, by deformation of said transverse connection area, between a rest position in which they are substantially aligned and opposed symmetrically with respect to a midplane passing through an axis of a semi-tubular transverse area, and a position in which they are folded towards each other.

13. A surgical staple according to claim 10, wherein a the distance between pointed ends is greater than a distance between said gripping surfaces when said staple is closed.

14. A surgical staple according to claim 10, wherein a the distance between pointed ends is less than a distance between said gripping surfaces when said staple is closed.

15. An applicator for a surgical staple, said applicator comprising at least one tubular element with a cross section corresponding substantially to a transverse envelope of said surgical staple, a movable member having a means of temporary cooperation with coupled to a transverse connection area of said staple in order to move said staple relative to said tubular element, and means for deforming said legs of said staple an interaction between said cooperation means and said transverse connection area is achieved on the internal surface of the transverse connection area, and said deformation of said staple is achieved by an interaction between said external surface of said legs and a front end of said tubular element.

16. An applicator for a surgical staple according to claim 15, wherein said staple is placed in a longitudinal position in a tubular extension and articulated so as to tilt when extracted out of this tubular extension.

17. An applicator for a surgical staple according to claim 15, wherein said staple is placed in a transverse position and driven by a lug secured to a rod movable longitudinally against the front surface of a tubular sleeve.

18. A method for manufacturing a staple, the method comprising cutting two movable arms of said staple connected by a transverse connection area from a metal sheet, each of said arms having a gripping area and an attachment end, said transverse connection area being deformable so as to enable said movable arms to be brought together by folding about an axis of said transverse connection area.

19. A method for manufacturing a staple according to claim 18, wherein said cutting is carried out with a tool inclined constantly during the cutting path, with an angle of between 10 and 55.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0019] The invention will be understood better from a reading of the following description, referring to the accompanying drawings corresponding to non-limitative example embodiments, where:

[0020] FIG. 1 shows a perspective view of a staple according to a first variant embodiment of the invention;

[0021] FIG. 2 shows a plan view of this staple in the open position;

[0022] FIG. 3 shows a plan view of this staple in the closed position;

[0023] FIG. 4 shows a perspective view of a staple according to a second variant embodiment of the invention;

[0024] FIG. 5 shows a plan view of the staple in the closed position;

[0025] FIG. 6 shows a perspective view of a staple according to a third variant embodiment of the invention;

[0026] FIG. 7 shows a plan view of the staple in the open position;

[0027] FIG. 8 shows a plan view of a fourth variant of a staple in the open position;

[0028] FIGS. 9 and 10 show views of an example of a staple applicator respectively during the phase of introducing the endoscope during the stapling phase;

[0029] FIG. 11 shows a view of a second example of a staple applicator; and

[0030] FIGS. 12 to 14 show views of another overall staple/applicator example.

DETAILED DESCRIPTION

Detailed Description of a First Example Embodiment of a Staple

[0031] FIGS. 1 to 3 show views of a first example embodiment of a staple according to the invention. The staple has, in front view, a roughly semi-annular or horseshoe form. In the example described, the staple is formed by cutting steel or titanium but may also be formed by shaping a metal wire or biodegradable material. In this preferred example, the material is rigid and deformable with low elasticity and without shape memory, so as to preserve the shape imposed during deformation for bringing together the arms.

[0032] It has two arched arms (1, 2) extending symmetrically with respect to a midplane (3) passing through the middle of a connection portion (3). The middle portion (3) designates simply the part lying between the two arms (1, 2). There is no separation between this area referred to as the connection portion (3) and the arms (1, 2) in the example described. However, in other embodiments, it can be envisaged providing an area (3) connected to the arms (1, 2) by hinges or folding lines.

[0033] This middle portion (3) has a semi-tubular shape and is produced by rearward deformation of the material with a cylindrical die. The semi-tubular form of the middle portion (3) allows positioning of a guide member provided at the end of an endoscope instrument, in order to facilitate manipulation of the staple at the time of its fitting. Each of the two arms (1, 2) has a pointed end (11, 21) in the form of a hook, extending in front of the transverse plane (12, 22) containing the corresponding arm (1, 2).

[0034] The tangent (13, 23) to the pointed end (11, 21) forms, with respect to the normal (14, 24) to the transverse plane (12, 22), an angle greater than 0 and less than 90, and preferably between 5 and 50. This pointed end makes it possible to hook onto the tissues in the vicinity of the area where the staple is placed, and to exert a lateral traction to bring them together before stapling. When the angle formed by the tangent is large, dragging the tissues without perforating them is favoured. If the angle is smaller, penetration of the pointed end into the tissues is favoured.

[0035] The two arms (1, 2) also each carry a hook (15, 25) projected in front of the transverse plane (12, 22), and positioned closer to the pointed end (11, 21) than the transverse connection area (3). The pointed attachment end (11, 21) and the hook (15, 25) can be produced so as to form a split end of the arm (1, 2), one of the tongues of this split end forming the attachment point (11, 21) and the other forming the hook (15, 25).

[0036] In the example described, the uncoiled length of the attachment point (11, 21) is substantially equal to the uncoiled length of the hook (15, 25). This hook (15, 25) has a gripping surface (16, 26) parallel to the transverse plane (12, 22). This gripping surface (16, 26) will come to bear on either side of the tissues at the time of stapling, to ensure holding thereof without perforating same.

[0037] The functioning of the staple is as follows: the staple is positioned against the two lips to be stapled with an applicator. The staple is in the open position and the two pointed ends (11, 21) fit flush with the tissues on either side of the separation line of the two lips. These pointed ends (11, 21) slightly penetrate the tissues and hook onto them in order to bring them together when the staple starts to be closed by an instrument folding the two arms (1, 2) with respect to the median axis passing through the tubular part of the transverse area (3). The pointed ends (11, 21) then make a sweeping movement in an arc of a circle, which brings the tissues at the edge of the lips between the two arms, between the two hooks (15, 25). When the two arms are folded against each other, the gripping surfaces (16, 26) hold the edges of the lips in position.

[0038] The functioning is as follows. The staple is in the open position before use, that is to say the arms are separated from each other. They may, in some embodiments, be aligned with each other so as to facilitate the introduction of the staple into the endoscope tube with a small cross section.

[0039] When the pointed ends (11, 21) come into contact with the tissue lips to be brought together, they penetrate the tissues very superficially, to form two anchoring points. When a force is applied to deform the staple and to bring the two arms (1, 2) together, these anchorings make it possible to drag the tissue lips in order to bring them together and to make the edges of the lips enter the opening form between the two arms (1, 2) of the staple. These edges are brought into the midplane of the staple and come into contact with the non-pointed semi-tubular surface (25, 26) of the two hooks (15, 25), which do not penetrate the tissues but exert a pressure in opposite directions and grip the tissues. When the arms (1, 2) are folded in a substantially parallel position with respect to each other, the gripping surfaces of the tissues are substantially parallel and exert a pressure perpendicular to the surface of the tissues, which holds the two edges of the tissues against each other.

Detailed Description of a Second Example Embodiment of a Staple

[0040] FIGS. 4 and 5 show another variant embodiment where the arms (1, 2) form a V, the opening of which decreases on opening. It can be produced by folding a metal rod in order to form two arched arms (1, 2) each terminating in a forked end defining an attachment end (11, 21) and a hook (15, 25) for gripping the tissues when the staple is closed.

Detailed Description of a Third Example Embodiment of a Staple

[0041] FIGS. 6 and 7 show another variant embodiment where the arms (1, 2) carry a plurality of hooks (15, 17; 25, 27) each having a gripping surface (16, 18; 26, 28). This solution makes it possible to increase the gripping surface of the tissues.

Detailed Description of a Fourth Example Embodiment of a Staple

[0042] FIG. 8 shows another variant embodiment of a staple cut from a metal sheet by laser cutting or water-jet cutting. The direction of cut is either perpendicular to the plane of the metal sheet or inclined by an angle of between 10 and 55 that is constant throughout the path of the cutting, in order to form a staple having inclined faces facilitating loading onto the applicator. The staple has a constant thickness and a configuration having two arms (1, 2) extending on either side of a curved area, each arm (1, 2) having a first claw respectively (11, 21) and a hook respectively (15, 25).

Detailed Description of a First Example of an Applicator

[0043] FIGS. 9 and 10 present a first example of an endoscope applicator, for a staple corresponding to the second example embodiment. In the position of introduction of the endoscope, the staple is oriented longitudinally, so that the two arms (1, 2) are aligned with the axis of the tubular end of the endoscope. The semicircular segment (3) extended on either side by the arms (1, 2) is positioned around a cylindrical lug (30) carried by a longitudinally movable rod (31) that is actuated by an external control member. When the staple is positioned, the operator pushes the rod (31) in order to make the whole of the staple emerge from the tubular sleeve (32) provided at the end of the endoscope. The following step consists of withdrawing the movable rod (31), which causes the tilting of the staple, the back of which comes into contact with the front surface of the tubular sleeve (32). The staple then comes to be positioned transversely, after having tilted at 90, and the two arms (1, 2) come into contact with the front surface of the sleeve (32), as shown in FIG. 9. When traction is continued to be exerted on the control member of the rod (31), the deformation of the staple and the bringing together of the two arms (1, 2) are caused, and consequently the attachment of the tissues by the pointed ends (11, 21), and then gripping thereof by the hooks (15, 25).

Detailed Description of a Second Example of an Applicator

[0044] FIG. 11 shows another example embodiment of an applicator according to the invention. In this example, the staples are positioned transversely, the tubular part of the central area (3) being placed at the rear of a lug (30) supported by a transversely movable rod (31) that is actuated by an operator using an external manipulation member.

[0045] When the operator withdraws the rod (31) towards the rear, the lug (30) drives the staple until the rear surfaces of the arms (31, 32) come into contact with the front end of the tubular sleeve (32) provided at the end of the endoscope. This front end has two flats (35, 36) providing the wedging of the arms (1, 2) of the staple. By continuing the traction force, the staple is deformed and the two arms (1, 2) move closer together, which causes the attachment of the tissues by the claws (11, 21), and then the gripping of the tissues between the two hooks (15, 25).

Description of Another Staple/Applicator Assembly

[0046] The staple has two arms (1, 2) that are aligned before positioning. The staple has, between these two arms (1, 2), a transverse connection area (3). This transverse connection area (3) is in the general form of a C, symmetrical with respect to the midplane (4) of the staple. This transverse connection area (3) has, on either side of the midplane, an arched portion (51) extending over an angle of preferably between 70 and 85 extended by a second arched portion (52) with an angle of curvature in the opposite direction extending over approximately 180. This second arched portion (52) is itself extended by a third portion (53) perpendicular, before deformation, to the symmetry plane (4). This third portion (53) has a bifurcation (54) extended by a hook forming the gripping area (15, 25) on the one hand and by a second hook, the two hooks being curved towards the inside of the staple.

[0047] The transverse connection area (3) has notches (55, 56) partially enclosing the opening, so as to allow the engagement of a deformable hook (60) provided at the end of the applicator rod (61). To allow introduction into an endoscope tube (62), the staple is placed longitudinally, in an open position in which the two arms are aligned, one of the arms (2) being applied against the rod (61) and the other arm (1) being opposed, in line with the rod (61).

[0048] The applicator makes it possible to bring the staple to the positioning point. The rod (61) is then pushed in order to make the staple emerge from the end of the endoscope tube, which causes the tilting of the staple. By next withdrawing the rod (61), the hook (60) drives the transverse connection area (3) in the end piece of the endoscope tube (62), until the rear surface of the arms (2, 3), at the second section (52), comes to be locked against the front edge (63) of the end of the endoscope tube (62).

[0049] In continuing the traction on the rod (61), the second portion (52) deforms, which causes the ends of the arms to come together, and in particular the two hooks forming respectively the attachment areas (11) and the gripping areas (15, 25). When the staple is closed, the hook is unhooked, increasing the traction on the rod, which deforms the hook, which opens and disengages from the transverse connection area (3) of the staple. The invention relates to staples, and in particular staples having before use the form illustrated by FIG. 12, of applicators for endoscopic insertion and stapling, as well as systems comprising an applicator and suitable staples.