FR2481594A1 - PERFECTED PLASTIC SURGICAL STAPLE - Google Patents

Abstract

MONOBLOCK SURGICAL STAPLE IN MOLDED PLASTIC MATERIAL, WITH AUTOMATIC LOCKING. THIS STAPLE 10 HAS TWO POINTED, OPPOSITE, HINGED BRANCHES AT THE OPPOSITE ENDS OF A CENTRAL BEAM 11 WHICH HAS ON ITS SIDE WALLS, NEAR THESE ENDS, CAM SURFACES 13. EACH BRANCH HAS TWO ARMS BODIES 17 CAM FOLLOWERS WHICH, WHEN THE CLIP IS CLOSED BY SWIVELING THE 90 BRANCHES, MOVE ON THE CAM SURFACES AND CROSS THEM TO LOCK INTO SUPPORT AGAINST THE CENTRAL BEAM END. THESE STAPLES, WHICH CAN BE USED AS TISSUE FIXING DEVICES DURING SURGICAL OPERATIONS, MAY BE EXTRUDED OR MOLDED INTO A BIOCOMPATIBLE, ABSORBABLE OR NON-ABSORBABLE PLASTIC MATERIAL.

Description

248-1594

-1-:

  The present invention relates to staples

rurgical. In recent years, the use of surgical staples has become very widespread as an alternative to the use of sutures to close the skin incisions, fascia and

  internal organs. The staples present, in some

taine applications, an advantage over sutures because of the speed and ease with which they can be placed. In addition, we designed and produced special stapling instruments that lay a whole row

  or a circle of staples in a single operation to sim-

  plan and accelerate the surgical method even more

  gicale. The surgical staples currently in use are made of tantalum or stainless steel wire with sufficient tensile strength and flexural modulus to ensure that the stapled post will remain closed. Although it has long been recognized that it would be desirable to use fabricated staples

in plastics or polymers, the realization

  sation of such staples has proven difficult due to the inherent elasticity of such materials. Staples made of plastic compositions

  known and having the same configuration as a metal clip

  lique do not have sufficient mechanical strength and flexural modulus to remain closed after being laid. A solution for using materials

  plastics in surgical stapling methods a.

  consisted of using cooperating mechanical means to block the clip in its installed configuration. The patent

from USA NO 2,881,762 proposed the use of a circlip

  ring type of open ring whose ends are

  designed for piercing fabrics, overlapping and being

  -2- rust so as to form a closed ring passing through the tissue, similar to a knotted sutjire. More recently, the use of a two-piece staple has been suggested in US Patent No. 4,060,089, according to which a fixing bar provided with teeth pierces the tissues while a cooperating retaining bar clamps the teeth of the side

opposite of tissues. The application of this device is li-

limited to cases where you can have access to both

  sides of the fabrics, and it is necessary to use an ou-

  til special to apply the device.

  One of the aims of the present invention is to produce a plastic surgical clip which functions in a manner analogous to that of a metal clip, that is to say a device in one piece which is placed at from one side of the tissue. Another object of the present invention is to produce a staple

made of plastic which can be laid with an instru-

classic design. Yet another object of the present invention is to produce staples in material

  plastic made of biologically ab-

  sorbable as well as in conventional non-absorbent polymers

  bables. These objects, as well as other objects of the invention,

will appear on reading the description which follows

  and examining the appended claims.

In accordance with the present invention, there is provided a one-piece clip, molded from plastic,

  self-locking, which includes a central beam

trale provided with L-shaped staple branches extending outwards and downwards fixed at each of its ends by hinges coming from molding. The central beam has on its side walls flared cam surfaces at each of its ends and each branch has an elastic arm which extends above the cam surface of the central beam and ends -3-

  by an inward-facing cam follower.

  The clip is closed by rotating the

staple branches around the hinges, -the elastic arms-

  that rotate and are pushed aside when the organs follow

cam actuators move on the cam surfaces until the cam follower members have passed the end of the central beam after which the

  arms close and bear against the extremi-

  tees of the aforementioned beam to lock the branches

  in their pivoted position.

The staple is placed in the tissue using

a conventional stapling mechanism that includes an anvil

  me and a formatting matrix. The anvil supports the-

central beam while the shaping matrix acts on each of the branches, causing them to pivot around the hinges, While the clip closes, the branches pierce the fabrics and form a boot-like configuration enclosing a segment of the fabrics, staple tips approaching each other inside

fabrics.

  The clip can be machined or molded from a material

any suitable polymer and, in particular, in com-

biologically absorbable or nonabsorbable positions.

The preferred absorbable materials are, in particular, polymers of lactide and glycolide. Preferred nonabsorbable materials are, in particular, nylon and polypropylene.

  Other features of the invention appear

  will read the following description and

examining the appended drawings in which - FIG. 1 is a perspective view of a surgical clip according to the present invention, - FIG. 2 is a plan view from above of the clip of FIG. 1,

  - Figure 3 is a side elevational view, -

-4- with partial section, of the clip of Figure 1, - Figure 4 is a sectional view along line 4-4 of Figure 2, - Figure 5 is a sectional view along line 5-5 of Figure 2, - Figure 6 is a view which shows the clip of Figure 1 in the arrangement it occupies with respect to the shaping anvil, to the shaping matrix and to the incision which must be closed, - Figure 7 is a view similar to that of Figure 6 which shows the clip during its shaping, - Figure 8 is a similar view which shows the clip completely shaping and closing the incision,

- Figure 9 is a view similar to that of.

Figure 5, showing the incision after the shaping tool has been removed, - Figure 10 is a perspective view showing

the clip of Figure 1 in its fully closed position

  mée et locked, - Figure 11 is a perspective view which shows an incision suitably closed by a series of staples according to the invention, - Figure 12 is a perspective view which shows a series of staples of the type shown in the figure 1 carried by a longitudinal bar in order to be

  used in a repeating stapler.

In Figures 1 to 3 to which reference will be made, - there is shown a clip 10 according to the present invention

  which comprises a central beam 11 and branches of agra-

fe-12 which are joined to their base by hinges 14.

The central beam 11 has flared side walls

which form inclined cam surfaces 13 and plates

  cam head 15 at each of their ends. Arms 16 extending from the articulated end of each staple branch, these arms 16 extending above the cam surfaces 13 and ending in members 17 cam followers oriented towards the inside. The distal ends of the branches 12 are sharp to form points 19 for piercing the tissues. The base of the beam optionally has a notch or recess, as shown, to form an anvil guide,

as more fully described below.

  The cam follower members 17 have a bevelled surface 18, as shown in FIG. 4, for

  form an inclined cam surface to come to rest

  against the cam surfaces of the central beam. Figure 4 is a sectional view along line 4-4 of the

figure 2.

  Figure 5 is a sectional view along line 5-5 of Figure 2 and shows the relative dimensions of the central beam and arms 16. The beam 11 preferably has a height / width ratio of at least

  about 1.5 to provide the desired structural rigidity.

The successive steps of fitting the clip 10 in order to bring the tissues closer to an incision made in the skin have been shown in FIGS. 6 to 9. The clip is closed using a conventional setting tool.

forms staples, which includes an anvil 21 and a ma-

trice 22 in the shape of a stirrup, shown partly on the

Figures 6 to 9.

As shown in FIG. 6 which will now be referred to, the clip 10 is positioned in the shaping tool by suitable means of

-30 way that the central beam 11 is supported by the anvil

  me 21 and that the ends of the matrix 22 are in

  stop against the staple branches 12. The anvil 21 comprises

te a central part forming a shoulder which is des-

tiné to engage in the recess 20 of the beam 11 and -6- which ensures that the clip is centered on the front anvil

the closure. We place the shaping tool and the

  fe directly above the incision 24 formed in the

fabrics 25. Since the staple branches extend

  tooth above the level of the anvil, the branches are brought to establish an initial contact with the tissues and

  may penetrate slightly into the tissue when the

The shaping til is positioned over the incision.

  The clip is closed and the edges of the incision are tightened by lowering the matrix 22 beyond the anvil 21, as shown in Figures 7 and 8. In step - of Figure 7, while the staple begins to close, the branches 12 penetrate the skin in a tissue gathering arc and the arms 16 pivot towards the

high while the cam follower members 17 move

cent against the cam surfaces 13 of the beam 11. The bevelled surface 18 of the cam follower members has the

same tilt angle as the corresponding cam surface

laying and it facilitates the passage of the arms during this movement. When the arms 16 pivot upwards, the

arms facing each other that extend from each branch

che are separated from each other by the action of the cams.

  When the degree of pivoting has exceeded about 90, the cam follower members move on the cam plates 15 and cross the end of the beam 11, after which the arms suddenly resume the initial spacing relationship and the cam follower members bear against the end surface of the beam 11, as more particularly shown in 3.0 figure 10. The clip is then firmly locked

in its closed position. Once the staple is

rusty, the matrix 22 is lifted and the shaping tool is removed, leaving the staple securely fixed in the tissue across the incision with the -7-

  edges of the incision suitably turned over as shown

  felt in Figure 9. Figure i1 shows an inci-

complete zion suitably closed by means of a series

  of staples according to the present invention.

'' Cam plates 15 are optional but are preferably used to give edges

  end walls of the beam a mass and a resistance

appropriate and to eliminate the risk that the end wall will yield under stress once the arms

have been hung in the locked position.

  For similar considerations, bevel 18 of the

  cam follower ganes do not extend to the base of the

arm 16 in order to guarantee the structural integrity of the

cam follower gane.

  As shown and as described above, the

  external parts of the staple may have, overall

  ble, a rectangular configuration while the seg-

  The tissue piercing elements preferably have a sec-

  circular transverse tion to facilitate penetration

  tion and minimize tissue trauma.

  The staples of the present invention can be molded as a series of staples joined between

them by a longitudinal link bar, as re-

shown in Figure 12. The longitudi-

  nale 26 allows you to load a series of staples into an ins-

do it with the staples-repeating which also includes

In addition to the matrix and the laying anvil,

  above, a knife to separate the staples from the link bar as the staples are

  moved to the installation position in the instrument.

  ment also preferably comprises means for collecting the pieces of sectioned connecting bar in order to prevent their accidental loss in the location of the incision,

In Figure 12, the staples have been shown

  widely spaced tees on the long link bar

  for the clarity of the illustration while in practice

  ticks the staples would be closely spaced from each other. Other methods can also be used to form a series of staples joined together, such as, for example, that of molding a

  series of staples whose adjacent arms are glued together

  ble at one or more locations. Individual staples can be separated from such a molded assembly - without having

  to worry about picking up pieces of connecting bar

its severed.

Although the staple of the present invention has been described and shown in its application to closure

  from an incision formed in the skin, one can also use

  read this clip to close an incision formed in an aponeurosis or in internal organs. Since the staple is designed to be used with staple laying tools of a conventional design, the use of

the staple in repeatedly stapled instruments

  ted by cartridges or in instruments which place a series of staples along a straight line or a circle at the

by means of a single trigger operation between equal-

ment in the context of the present invention. He's good -

  understood that it may be necessary to make certain modifications to existing stapling instruments so that they can physically receive the staples of the present invention but the provision of such modifications falls entirely within the scope of current skills

manufacturers of surgical instruments.

You can build the staples of this in-

vention in sizes that match the sizes of conventional metal staples. In a staple of

medium size, the central beam can have a long

  -9- length between approximately 2.5 and 6 mm while the

  L-shaped staple branches and arms that pro- vide them

  are skirted in a proportioned way,

as shown, for example, in Figure 1.

The staples can be made using any suitable plastic forming technique including extrusion and injection molding according to the staple model and the composition of the material which may be any of various known polymeric compositions as being biocompatible

in surgical applications. Nylon, poly-

propylene, polyester and polysulfone are examples of the materials that can be used to make nonabsorbable staples. Homopolymers and copolymers of lactide, glycolide, and pdioxanone are examples of the materials that can be used to make staples for internal applications. Other polymeric compositions are known to those skilled in the art and can be used

  in the context of the present invention.

Non-absorbable staples can be used, for example

for example, polypropylene or nylon, in applica-

  internal tions in cases where absorption is not an important factor. In case such staples are

  used in external application, they can be removed easily

  LEMENT after the wound has healed sufficiently, simply by inserting a suitable tool under the central beam and pushing the branches of the clip - back to their original position which has been shown in Figure 1. During this removal, the elastic arms of the staple branches twist until the cam follower members have been pushed past the end of the central beam, allowing the staple branches to pivot around their point -10-

of articulation - and return to their original position.

The foregoing description and the figures of

attached drawings relate to an embodiment

preferred particular of the present invention and many

Many variations of this embodiment which will come to mind of those skilled in the art are within the general scope of the present invention. For example, in addition to the eligible variants mentioned above, there

it will become clear that the details of the cams of the branches

  staple pins and locking means can vary within very large proportions. Each staple branch

  may, for example, use only one extended arm

  and only one cam follower or another

staple branch cam and other locking means

  The appropriate age can be used. In still more

very embodiments, the central beam and the branches

  staple pins can be molded as individual pieces and assembled by means of hinge pins passing through the arms of the staple branches and entering the side wall in the vicinity of the end of the central beam. These and other construction variants are contemplated by the present invention

and fall within its scope.

-11-

Claims (26)

  1. A self-locking surgical clip   material, characterized in that it comprises: - a central beam (11); and - two staple branches (12) extending across shot from each end of the beam; the staple branches being joined to the central beam by articulation means (14) arranged so as to allow the staple branches to rotate relative to the central beam; - staple branches ending in tissue piercing segments (19) which come approxi-   matively in end-to-end alignment when the staple branches are pivoted relative to the central part; and   cam means (13, 15 16, 17), cooperating   rants, arranged respectively on the central beam and on the staple branches and arranged to lock the   staple branches in position with the piercing segments fabrics approximately aligned end to end when the staple branches have been moved in this way in rotation.   2. Clip according to claim 1, characterized in that the central beam (11) has walls opposite ends and in that the articulation means mentioned above (14) include a partition coming from ma-   face extending from each of the end walls tee to the corresponding staple branch (12).   3. Clip according to claim 2, characterized in that the central beam (11) has an upper surface and a base, located opposite, and in that   the aforementioned partition extends from the base.   4. Clip according to claim 1, characterized 2 2481594   -12- in that the central beam has opposite side walls and in that the cam means comprise at least one cam surface (13) formed on a wall   lateral flaring towards each ex- end of the beam. 5. Clip according to claim 4, characterized in that the cam means comprise, in addition,   at least one arm (16) extending from each branch   staple che above a cam surface (13) of a side wall and ending in an inwardly facing cam follower member (17) facing said side wall.   6. Clip according to claim 5, characterized in that the cam follower members (17) comprise a locking surface and are arranged so as to cross the cam surfaces (13, 15) and the ends of the central beam when the staple branches (12)   are moved in rotation relative to the central beam   trale, as a result of which the locking-surface comes- resting against the central beam to lock the   staple branches in their pivoted position.   7. Clip according to claim 5, characterized in that the cam follower members (17) are bevelled so as to have a face (18) inclined at the same angle than the aforementioned cam surfaces (13). 8. Clip according to claim 1, characterized in that the cam means comprise: - two flared cam surfaces (13) formed on   the side walls at each end of the central beam   trale; and - two arms (16) extending from each staple branch (12) above the cam surfaces and ending in a cam follower member (17) arranged   -face to the side wall of the central beam.   -13- 9. Clip according to claim 2, characterized in that the distance between the end walls is   between approximately 2.5 mm and approximately 6 mm.   10. Clip according to claim 1, characterized in that the clip branches (12) are L-shaped and extend horizontally from each end of the central beam. 11. One-piece, locking surgical clip   automatic beam, characterized in that it comprises: - a central beam (11); and   - two L-shaped staple branches (12)   tending from each end of the beam; the central beam being constituted by a rectangular member having an upper surface and a base, opposite end walls and side walls opposite, these side walls comprising at least one overlay flared cam face (13) at each end of the central beam; the staple branches being joined to the end walls by articulation means made of material (14), at one end, and ending, at their other end   mitered, by tissue piercing segments (19) which extend downward at right angles to the base of the central beam;   at least one elastic arm (16) extending through shooting of the articulated end of each staple branch (12) above a cam surface (13) flaring from the central beam; a cam follower member (17) extending through shot from the distal end of the arm and facing the   side wall of the central beam; - the cam follower being arranged to move cooperatively on the surface of cam flared and to pass through the end wall of the   -14- be central when the staple branches are rotated around the articulation means;   elastic arms flexing when their or-   the cam follower moves on the cam surface and until the cam follower has passed the end of the central beam; as a result of which the arms close and come to bear between the ends of the central beam, thus locking the staple branches in their posi- rotated tion. 12. Clip according to claim 11, characterized in that the articulation means (14) each consist of a partition extending from the base of the central beam to the corresponding base of the staple branch.   - 13. Clip according to claim 11, characterized in that the side walls have surfaces of   cam-opposite (13) at each of their opposite ends.   14. Clip according to claim 13, characterized in that each clip branch (12) comprises a pair elastic arms (16) which extend above the overhangs opposite cam faces (13) located at each end of the central beam. -   15. Clip according to claim 11, character- in that the cam follower members (17) are bevelled so as to have an inclined face (18)   at the same angle as the cam surface (13). 16. Clip according to claim 11, character-   in that the cam surface has a cam plate (15) adjacent to the end wall of the beam central (11). 17. Clip according to claim 11, character-   in that the base of the central part (11) is visible dée (in 20). 248 59 4 -15- 18. Clip according to claim 11, character- sée in that the segments (19) for piercing the fabrics of the staple branches (12) have a cross section circular. -   19. A clip according to claim 11, characterized in that the central beam (i1) has a height / width ratio of at least about 1.5., 20. An assembly characterized in that it comprises, -   in combination, a stapling tool having a shaping anvil (21) and a cooperating shaping die (22) and a surgical staple made of material plastic which includes: -   - a central beam (11); and - two staple branches (12) extending from   - from each end of the beam; - the staple branches being joined to the central beam by articulation means (14) arranged so as to allow the staple branches to rotate relative to the central beam;   staple branches ending in seg-   fabric piercing elements (19) which come approxi-   matively in end-to-end alignment when the staple branches are pivoted relative to the central part; and - cam-forming means (13, 15, 16, 17), cooperating rants, arranged respectively on the central beam and on the staple branches and arranged to lock the   staple branches in position with the piercing segments fabrics approximately aligned end to end when the staple branches have thus been moved in rotation; the shaping anvil (21) having a length approximately equal to the width of the central beam; the shaping matrix (2-2) comprising two -16 ends spaced so as to bear against the   staple branches when the central beam is posi- on the anvil, the distance between said ends mites corresponding approximately to the width of the clip after closing; the anvil and the shaping die being arranged so as to close the staple by rotating the staple branches relative to the central beam, after which the cam means lock the staple branches in the closed position with the tissue piercing segments (19) in approximately aligned matively end to end.   21. The assembly of claim 20, character- iized in that the ends (19) of piercing branches staple pins extend beyond the plane of the anvil (21) when the staple is centered on the anvil, before closing.   22. The assembly of claim 20, character- risé in that the central beam (11) comprises over- opposite upper and base faces and in that staple centering guide means are arranged cooperatively on the surface of the base (20) and on the shaping anvil. - 23. Clip according to claim 1, character- in that it is made of an absorbent polymer composition bable.   24. Clip according to claim 23, character-   in that the absorbable polymer composition is a homopolymer or a copolymer of lactide, of glycolide or p-dixanone.   25. Clip according to claim 1, character-   sée in that it is in a nonabsorbable polymer composition. 26. A clip according to claim 25, character-   In that the nonabsorbable polymer composition is   chosen from the group consisting of nylon, polyes-   ter, polypropylene and polysulfone.