EP1094757A1

EP1094757A1 - Apparatus for dispensing and setting i-shaped surgical staplers

Info

Publication number: EP1094757A1
Application number: EP00917128A
Authority: EP
Inventors: François Régis ORY; Michel Therin
Original assignee: Sofradim Production SAS
Current assignee: Sofradim Production SAS
Priority date: 1999-05-05
Filing date: 2000-04-05
Publication date: 2001-05-02
Also published as: AU3824300A; FR2793132A1; FR2793132B1; WO2000067644A1; JP2002543866A

Abstract

The invention concerns an apparatus comprising a handle body (A) equipped with control means and a connection piece (35) whereon is directly mounted and removably fixed an elongated element (B), for storing, dispensing and setting staples (1). The invention is characterised in that the elongated element (B) comprises a slide (6) linked to a control rod (22) capable of being actuated by first control means (40), said slide (6) comprising: projecting from its front end, a hollow needle (8) with a longitudinal slot, whereof the rear end is juxtaposed to a receiving chamber (9) of the head (T) of the first stapler (1a); opposite said receiving chamber (9), the rear end of a magazine (16) storing a plurality of staples (1); and in the extension of the hollow body (8) and the receiving chamber (9) for the staple head, a longitudinal channel (12) for a plunger (13) capable of being actuated by second control means (45); said plunger being arranged such that, when the slide (6) is in quiescent position, its free end is in said receiving chamber, and counters the reception of a staple head and that, when the slide has been moved by the first control means (22) to cause the needle (8) to project outside the elongated element and to be engaged in the tissues to be assembled, said plunger end is outside the receiving chamber (9) and can, after a staple head has been received in said chamber (9) and the second means (46) have been actuated, push said head (T) into the needle (8) channel.

Description

APPARATUS FOR DISTRIBUTING AND LAYING "I" SURGICAL FASTENERS

The invention relates to an apparatus for distributing and placing surgical "I" fasteners which can, for example, be used to fix parietal and visceral reinforcements.

It aims more specifically to replace the permanent metal fasteners and staples with plastic fasteners, for example, in absorbable material, having a temporary function, in relation to the time of the reinforcement tissue rehab, while providing an anchoring excluding risk of nervous pinching.

Already known in the textile industry a plastic fastener having the general shape of an "F, that is to say composed of a head, a connecting filament, and a foot. clip is distributed and put in place by means of a pistol-shaped device, the barrel of which is extended by a hollow needle and the body of which is provided with a manual actuation control. a label on a garment, the needle is engaged transversely in these elements, by manual insertion, then the actuation of the manual control causes, by the displacement of a pusher disposed in the longitudinal axis of the needle channel:

- the removal of a fastener forming part of a fastener bar, waiting in a store;

- displacement of the head of the fastener in the axial channel of the hollow needle;

- the crossing of the plies by the head of the fastener circulating in the needle; - then, as soon as the connecting filament comes into contact with the plies, its drawdown against the head and its engagement in the plies with the rest of the head, until the head is completely disposed on the other side of the plies to assemble.

At the end of actuation, a means, for example a spring, recalls the plunger and the needle is withdrawn manually. Under the action of the elasticity of the material constituting the fastener, the head thereof returns to its initial position and returns substantially perpendicular to the connecting filament, ensuring the anchoring of the fastener on the rear face of the sheets. . These are then trapped between the head and the foot of the fastener which also extends transversely, but on the front face of the sheets. It has been envisaged to transpose this type of fastener to ensure surgical ligatures by making the fastener in plastic material and, in particular, in bioresorbable material, and in distributing it by means of an equivalent distributor. It was then revealed drawbacks arising from the space generated by the strip of fasteners projecting from the dispenser's nose, and from those inherent in compliance with surgical specifications and, in particular, sterilization. This is the case for the devices described in US-A-4,448,196 and WO98 / 51179.

The object of the present invention is to provide a dispensing device overcoming these drawbacks. This dispensing device comprises a handle body equipped with manual control means and a nozzle on which is attached and removably fixed a elongated element for storage and distribution of fasteners.

According to the invention, the elongated element contains, near its free end, a slide linked, on the one hand, to a control rod actuable by first control means, between a rest position and a working position , and, on the other hand, to return means in the rest position, said slide comprising:

- projecting from its anterior end, a hollow, longitudinally split needle, the posterior end of which is juxtaposed with a chamber for receiving the head of the first attachment;

- facing said chamber, the anterior end of a storage warehouse with several fasteners;

- And in the extension of the hollow needle and the receiving chamber of the attachment head, a longitudinal channel for a pusher actuable by second control means; said pusher being arranged so that, when the slider is in the rest position, its free end is in the aforementioned receiving chamber and is opposed to the reception of a fastening head and that, when the slider has been moved by the first control means to project the needle out of the elongated element and engage it in the tissues, said end of the pusher is outside this chamber and can, after reception of the attachment head in this chamber and actuation of the second control means, push this head into the needle channel.

This device is therefore composed of a handle body on which is attached a elongated element which can have all the guarantees of asepsis and contain a quantity of fasteners sufficient for a standard operation, this elongate element being systematically replaced with each new operation. The arrangement of the fastener storage store in the elongated element does not increase the overall size of the device and makes it possible to guarantee the sterilization of the fasteners. The external diameter of the elongated element is constant over the entire length and compatible with its use in laparoscopy. When this device is used, the actuation of the first control means causes the longitudinal displacement of the slide and, therefore, of the needle which leaves the free end of the elongate element and can pass through the human tissue to be assembled. This movement also releases the reception chamber from the head of the first fastener and thus allows this head to come into the dispensing position. The actuation of the second control means causes, under the action of the pusher, the displacement of the head of the fastener in the hollow and split needle and, consequently, the transfer of this head beyond the human tissues in front to be assembled. At the end of the movement, return means return the pusher and the magazine to the initial rest position, that is to say retracts the needle in the elongated element by bringing the slide into the position where its distribution chamber is closed by the end of the pusher which opposes the positioning of the head of the next fastener.

It appears from the above that it is the displacement of the slide forming a storage magazine which makes it possible, in combination with the pusher, to ensure the distribution one by one of each of the fasteners contained in the magazine.

Advantageously, the front end of the fastener storage magazine comprises, facing the slide receiving chamber and in the longitudinal trajectory of the head of the first fastener, a ramp tending to drive said head transversely into the chamber reception. This arrangement facilitates the transfer of the attachment head from the storage magazine to the receiving chamber juxtaposed with the hollow needle.

In a preferred embodiment, the slide comprises, facing a release chamber formed in front of the front end of the magazine and in the path of the attachment feet, an inclined ramp tending to move the foot of the first fastener during the longitudinal displacement of the latter.

Thanks to this arrangement, when the attachment foot leaves the end of the elongated element it is not parallel to the longitudinal axis of this element, it does not risk bracing against the first fabric since due to this transverse inclination it naturally tends to tilt against the first fabric to be assembled. In one embodiment of the invention, the first control means comprise an “L” lever, articulated near its elbow on the handle body, said lever comprising a large branch, bearing on the end of the slide control rod, and a small branch directed towards the end piece of the body, while the second control means comprise a handle, of general "L" shape, articulated near its elbow in the handle body on an axis distinct from that of the articulation of the aforementioned lever, said handle comprising:

- On the one hand, a small branch substantially parallel to that of the aforementioned lever to which it is connected by a tension spring, said spring forming a rod for controlling the pivoting of this lever in a first phase of exit of the needle from the elongated element;

- And secondly, a large branch substantially parallel to that of the lever and having a suitable ramp, in a second phase of distribution and installation of a fastener, to come into abutment against a member secured to the fastener pusher. Thus, by a single movement on the articulated handle, the operator successively actuates the first control means moving the slide and the hollow needle and freeing the receiving chamber, then the second control means moving the pusher and ensuring the installation of the attached.

Other characteristics and advantages will emerge from the description which follows with reference to the appended schematic drawing showing by way of example an embodiment of this distribution and fastening device.

Figure 1 is a side elevational view of the device when the elongate member is assembled to the handle body.

Figure 2 is a partial exploded perspective view with partial section of the free end of the elongated element showing the slide and the various control means, distribution and installation.

Figure 3 is a longitudinal sectional view showing on an enlarged scale and schematically the different functional elements of the device.

Figures 4, 5 and 6 are views in longitudinal section of the handle body and its connecting means with the elongated element when the handle is respectively in the rest position, in the actuation position of the first control means and in position actuation of the control member of the pusher.

Figure 7 is a longitudinal sectional view showing on a larger scale the tip of the handle body and the rear end of the filiform element with its connecting means on the tip. Figure 8 is a longitudinal sectional view of the elongate element according to VIII respectively. VIII of figure 1.

Figure 9 is a longitudinal sectional view along IX .IX of Figure 8 showing more particularly the storage store of fasteners. Figures 10 to 13 are sectional views along XX of Figure 8 when the device is respectively resting on two assembled fabrics after movement of the needle, during the distribution of a fastener and at the end of distribution after the return slide and pusher to their starting position.

Figure 14 is a front view of a clip distributable by the device. Figure 15 is an enlarged scale view in section along XV-XV of

Figure 1.

This device is intended to distribute and install staples 1, having, as shown in Figure 14, the shape of a "I" lying and composed of a head "T" of a foot "P" and a filament of link "F". Depending on the applications, such staples are made of biocompatible material, absorbable or not.

This device essentially consists of a handle body "A" and a elongated element "B". This elongated element is generally independent of the body A. The connection between the two elements will be defined later with reference to FIG. 7. In known manner, the handle body “A” contains control means while the elongated element “ B ”contains means for storing the fasteners and means for distributing and laying the latter.

There will first be a description of the elongated element “B”, of its means of connection to the body “A”, of the handle and then of the control means. The elongated element “B” is composed of a tubular body generally designated by 2 and itself formed by two or four semi-cylindrical shells 2a, 2b, 2c, 2d linked edge to edge and butt to butt by welding ultrasonic. As shown in FIG. 15, the body 2 of the tubular element delimits a cylindrical housing 3 in which protrude longitudinal ribs 4 cooperating with grooves 5 formed longitudinally and on the sides of a slide generally designated by 6. The elongate element “B” is internally reinforced by rings of material, the most anterior of which 7a in FIG. 10, form of end of return stroke stop for the slide 6, while that 7b in FIG. 3 serves to support means of recall. For manufacturing reasons, the cylindrical slide 6 is itself produced in two parts 6a and 6b which are assembled according to one of their diametrical median planes by ultrasonic welding or by bonding.

As shown in more detail in Figure 2, the part 6a of the slide 6 is integral with a needle 8, hollow and split longitudinally, projecting from the anterior end of this slide. The rear end of the needle 8 is juxtaposed with a receiving chamber 9 of the head "T" of the first fastener to be dispensed.

In the embodiment shown, the receiving chamber 9 has locally a guide cone 10 formed in a front part 9a of larger diameter. This chamber 9 communicates with a channel 12 for guiding a cylindrical plunger 13. In the rear part of the slide 6 the channel 12 is formed partly in this slide and partly in an attached wall 14 fitting into a housing 15 of part 6a. The other part 6b of the slider 6 comprises, near its front end, the end of a storage magazine 16 bordered by longitudinal channels 16T and 16P respectively, heads "T" and feet "P" of the fasteners arranged in this store. At the front end of the magazine the guide groove 16T gives way to a ramp 17 which is arranged opposite the receiving chamber 9 of the other part 6a of the slide and in the trajectory of the head “T »Of the first attachment, for, during the movement of this first attachment la, communicate to its head« T »a transverse translational movement in the direction of the receiving chamber 9.

In front of the magazine, the front end of the part 6b of the slide comprises a clearance housing 18 which faces a ramp 19 arranged on the other part 6a and in the path of the foot “P” of the first attach it.

In Figure 2, the reference numeral 20 designates a thrust blade pressing the fasteners 1 towards the front end of the magazine 16 under the action of spring means which will be described later. As shown schematically in Figures 8 and 10, when the slide 6 is in the rest position inside the body 2 of the element "B", it is returned to abutment against the ring 7a so that the needle digs 8 is fully retracted inside the front end of the elongated element and the receiving chamber 9 is obscured by the front end of the pusher 13. This return to the rest position of the slide 6 is provided by a rod control 22 whose hook-shaped front end 22a is coupled to the end rear of said slide, while its rear end 22b protrudes from the rear end of the elongated element "B" to penetrate the handle body "A", opposite the control means. A spring 23 (FIG. 3), one end of which is linked to the body 2 of the elongated element "B" and the other end linked to the rod 22 ensures the return to the rest position of the slide.

The cylindrical pusher 13 is connected, by its rear end, to the front end of a tube 24 slidably mounted in the body of the elongated element “B” and itself serving as a guide element for the control rod 22. As shown diagrammatically in FIG. 3, the guidance of the tube 24 is ensured, among other things, by the various rings 7 internally reinforcing the body 2 of the elongate element and in particular by the ring 7b. This tube 24 also protrudes from the rear end of the body of the elongate element “B” to also penetrate the handle body “A. Its rear end is linked, for example by welding or crimping, to a piston 25. A helical compression spring 26 is interposed between the head of the piston 25 and the ring 7b to constantly exert on the tube 24, and consequently on the pusher 13, a longitudinal restoring force in the direction of arrow 31.

Finally and as shown in FIG. 3, the thrust blade 20 of the magazine 16 is connected, by a rod 28, to a ring 29 slidingly mounted inside the body 2 and on the tube 24. This ring is permanently subjected to the thrust of a compression spring 30 interposed between it and the partition 7b. This spring exerts on it a restoring force in the direction of arrow 32.

As shown in Figure 7, the rear end of the body 2 of the elongated element "B" is designed to engage in a tip 33, forming part of the handle body. This handle body, which is produced in two symmetrical parts assembled by rivets or screws 34, has on its end piece 33 a collar 35 and a groove 36. The first is intended to cooperate with stop means carried by a ring 37 which can slide on the rear end of the body 2 and the second with notches 38 formed at the end of elastic tongues 39, carried by this ring.

When the rear end of the element “B” is engaged in the end piece 33, its connection is ensured by displacement of the ring 37 in the direction of the end piece until the notches 38 lock in the groove 36 The front edge 36a of the groove 36 is slightly sloping so as to ensure the attachment while allowing the notches to be unlocked by a longitudinal tensile force. on the ring 37 for the replacement of the elongate element “B” used by another sterile element.

The various means which have just been described cooperate with control means which are 2 in number and which in this embodiment are manually actuated, as shown in FIGS. 4 to 6. The first control means, which are intended to actuate the rod 13 causing the displacement of the slide 6, comprise a lever 40 in the form of "L". This lever is articulated near its elbow on an axis 42 journalled in the two elements of the handle body

"AT". The large branch 41 of this lever comprises, near its free end, a cavity 43 by the bottom of which it bears on the head 22b of the rod 22, head which engages in this cavity during introduction of element B in the end piece 33.

The small branch 44 of the lever 40 is turned towards the front, that is to say substantially towards the end piece 33.

The second control means comprise a handle 45 having a side view of a general "L" shape, that is to say comprising a large branch

46 disposed substantially parallel to that 41 of the lever 40 and a small branch

47 disposed substantially parallel to that 44 of the lever 40. This handle is articulated on a transverse axis 48, distinct from the axis 42 of the lever. The small branch 47 is connected, by a tension spring 49, to the small branch 44 of the lever. In the rest position and as shown in FIG. 4, a bent return 44a of the small branch 44 comes to bear against the end of the small branch 47 of the handle. The large branch 46 of the handle 45 comprises, facing the piston 25, a ramp 50 which, at rest, is distant from this piston.

When the handle body “A” has received a elongated element “B”, the magazine 16 of which contains, as shown in FIG. 9, at least ten fasteners 1, the anterior end of the elongated element “A” is brought close to the fabrics 60 and 61 to be assembled, as shown in FIG. 10.

By pressing the handle 45, then in the position shown in Figure 4, the operator rotates it in the direction of the arrow 62 in Figure 5. This results in pivoting the small branch 47, which by the spring 49, in turn causes the pivoting of the lever 40. The large branch 41 of this lever then moves, in the direction of the arrow 53 of FIGS. 5 and 10, the head 22b of the rod 22 and, consequently, the slide 6. The latter thus passes from its rest position (FIG. 10) to its working position (FIGS. 11 and 12) in which the needle 8 projects from the end of the elongated element B and passes through the fabrics 60 and 61. Due to this displacement of the slide 6, not accompanied by a displacement of the pusher 13, the receiving chamber 9 is released from the end of the pusher and can thus receive the head "T" of the first fastener contained in the magazine.

This transverse displacement of the head “T” of the fastener la is effected by the combination of the longitudinal thrust SI of the blade 20 and of the part of the ramp 17 generating a component St visible in FIG. 8.

As soon as the head "T" is thus positioned, that is to say practically instantaneously, the pushing force on the handle 45 brings the ramp 50 of the latter in contact with the piston 25 and causes the longitudinal displacement of this piston in the direction of the arrow 63 Figures 6 and 12. Through the tube 24, this movement is transmitted to the pusher 13 whose end not only comes into the receiving chamber 9 but continues in the internal channel of the needle 8 for pushing the head "T" in this needle and beyond it, through the fabrics 60, 61 to be assembled. During this ejection movement of the head "T", the foot "P" comes into contact with the ramp 19, arranged under the needle, and inclined transversely. This has the effect of avoiding that its end arches on the fabrics as shown in FIG. 12 by hampering the crossing of these fabrics by the head T. In fact, this transverse inclination allows the foot to come to be disposed substantially parallel against the anterior part of the tissue, allowing the connecting filament to follow the movement of the head without difficulty. As soon as the operator releases the handle 45, the pusher 13 is returned to its starting and rest position by the spring 26, while the slider 6 and the needle 8 are returned to their starting position by the spring 23. These actions being simultaneous, the pusher 13 remains in the reception chamber 9 and prohibits that the head of the second fastener 1b can engage in this chamber thereby guaranteeing the proper functioning of this device. After use and in a preferred embodiment, the elongated element

"B" and its connection ring 37 are discarded, while the housing body "A" is sent to sterilization. In another embodiment, the assembly is disposable.

In an alternative embodiment, not shown, the control means arranged in the handle body "A" are replaced by pneumatic means with manual release by push buttons or drawers.

Claims

1 / Apparatus for dispensing and fitting surgical fasteners comprising a handle body (A) equipped with control means and a nozzle (33) on which a elongated storage element (B) is attached and removably fixed , distribution and installation of fasteners (1) characterized in that the elongated element (B) contains, near its free end, a slide (6) linked, on the one hand, to a control rod (22 ) actuable by first control means (40), between a rest position and a working position, and, on the other hand, by means (23) for returning to the rest position, said slide comprising:

- projecting from its anterior end, a needle (8), hollow and longitudinally split, the posterior end of which is juxtaposed with a chamber (9) for receiving the head (T) of the first fastener (la);

- facing said receiving chamber (9), the front end of a store (16) for storing several fasteners;

- And in the extension of the hollow needle (8) and the receiving chamber (9) of the attachment head, a longitudinal channel (12) for a pusher (13) actuable by second control means (45 ); said pusher (13) being arranged so that, when the slide (6) is in the rest position, its free end is in the aforementioned receiving chamber (9) and opposes the reception of the head (T) of the first attachment (la) and that, when the slide (6) has been moved by the first control means (22) to project the needle (8) out of the elongated element (B) and for the engage in the fabrics to be joined, said end of the pusher (13) is outside this chamber (9) and can, after reception of the head (T) of the first fastener (la) in this chamber and actuation of the second control means , push this head into the needle channel (8).

2 / dispensing device according to claim 1, characterized in that, the first control means comprise a lever (40) in "L", articulated near its elbow on the handle body (A), said lever comprising a large branch (42), bearing on the end (22b) of the control rod (22) of the slide (6), and a small branch (44) directed substantially towards the end piece (33) of the body, while the second control means comprise a handle (45), generally in an "L" shape, articulated near its elbow in the handle body (A) on an axis (48) distinct from that (42) of the articulation of the lever (40) mentioned above, said handle (45) comprising: - On the one hand, a small branch (47), substantially parallel to that (44) of the aforementioned lever to which it is connected by a tension spring (49), said spring forming a rod for controlling the pivoting of this lever, in a first phase of exit of the needle (8) from the elongate element (B); - And secondly, a large branch (46) substantially parallel to that (42) of the lever (40) and having a ramp (50) suitable, in a second phase of distribution and installation of a fastener (1) , to come into abutment against a member (25) integral with the pusher (13).

3 / dispensing device according to claim 2, characterized in that the member (25) integral with the pusher (13) is constituted by a piston mounted to slide in the rear end of the elongated element (B), said piston being permanently subjected to return means (26) projecting from this end and being linked to the rear end of a tube (24), guided in translation in the elongated element (B) and whose front end is linked to the pusher (13). 4 / dispensing device according to claim 1, characterized in that the front end of the store (16) for storage of the fasteners comprises, facing the receiving chamber (9) formed in the slide and in the longitudinal trajectory of the head (T) of the first attachment (la), a ramp (17) tending to drive said head transversely into the receiving chamber (9). 5 / dispensing device according to claim 1, characterized in that the slide (6) comprises, facing a release chamber (18) formed in front of the front end (6b) of the magazine (6) and in the path of the attachment feet (P), an inclined ramp (19) tending to transversely move the foot (P) of the first attachment (T) during the longitudinal movement of the latter. 6 / A dispensing device according to claim 1, characterized in that the fastener storage magazine comprises means for guiding a push blade pressing the fasteners towards the anterior end of the magazine, said blade being linked to a ring mounted sliding inside the elongated element and permanently subjected to the action of a return spring interposed between it and an internal partition of the elongated element. II Dispensing apparatus according to claim 1, characterized in that the slide (6), of generally cylindrical shape, is composed of two parts (6a, 6b) which assemble along a longitudinal and vertical median plane, namely, a part (6b) containing the magazine (16) for storing the fasteners and a pushing blade (20) pressing the fasteners (1) towards the anterior end of the magazine and a part (6a), integral with the hollow needle ( 8), carrying the receiving chamber (9) of the head of the first attachment and the longitudinal channel (12) for the pusher (3).