Classifications

• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/068—Surgical staplers, e.g. containing multiple staples or clamps
  • A61B17/0682—Surgical staplers, e.g. containing multiple staples or clamps for applying U-shaped staples or clamps, e.g. without a forming anvil
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/11—Surgical instruments, devices or methods, e.g. tourniquets for performing anastomosis; Buttons for anastomosis
  • A61B17/115—Staplers for performing anastomosis in a single operation
  • A61B17/1152—Staplers for performing anastomosis in a single operation applying the staples on the outside of the lumen
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
  • A61B17/064—Surgical staples, i.e. penetrating the tissue
  • A61B2017/0641—Surgical staples, i.e. penetrating the tissue having at least three legs as part of one single body

Definitions

• the suturing of the blood vessels is most often performed by using needles and non-absorbable threads.
• This technique is satisfactory in the majority of cases but mainly for vascular surgery of the large vessels, that is to say whose diameter is greater than 3mm.
• the technique is fast and reliable.
• Vascular anastomoses by Nakayama rings or coupler cannot be used for vessels less than one millimeter and only for end-to-end anastomoses. They are practically unusable for end-to-side anastomoses.
• the anastomosis of the laser must be associated with the placement of at least three points per conventional wire, which decreases the interest.
• Anastomosis with biological glue has the same drawbacks, the tensile force being insufficient to keep the two ends in contact and the use of associated points is also essential.
• the invention proposes a new process allowing 2 speed, simplicity and reliability of execution of these vascular micro-anastomoses, not having the constraints and imperfections of the previous methods as well as a clamp for its implementation, method and clamp distinguished by the characteristics enu erated in the claims independent 1 and 2.
• Particular embodiments are described and claimed in claims 3 to 8 as well as in the description which follows.
• the subject of the invention is a method of micro-anastomosis of vessels, in particular blood vessels, characterized in that two ends of vessels to be connected are applied end to end and that the walls placed end to end of the vessels are connected in several places. by crimping metal micro-staples.
• the invention also relates to a device for implementing the method according to claim 1, characterized in that it comprises a housing provided with a clamp for gripping and crimping the staples, by the fact that this housing contains a mechanism for crimping staples by actuation on the clamp comprising an accessible control member, from the outside of the housing; a clip loader and a mechanism for transferring a clip from the charger between the tongs of the clamp also controlled by a member accessible from outside the housing.
• FIG. 1 is a general perspective view of the clamp according to the invention.
• FIG. 2 illustrates on a larger scale the beaks of the clamp holding a staple to ask.
• FIG. 3a illustrates on a larger scale a clip.
• FIG. 3b illustrates a detail of a tip of the clip illustrated in Figure 3.
• Figures 7, 8, 10 are sectional views along a plane perpendicular to the plane of symmetry of the clamp corresponding to the views of Figures 4, 5, 6 respectively.
• FIG. 9 is a partial section of the clamp similar to Figures 4 to 6 and illustrating on a larger scale the mechanism for loading the clamp with a staple.
• FIG. 11 illustrates the horizontally movable part of a mechanism for placing a new clip in the branches of the clamp.
• - Figure 12 is a cross section of the clamp.
• FIG. 13 to 15 schematically illustrate the installation of a clip using the pliers.
• FIG. 16 and 17 illustrate a mechanism for pre-adjusting the crimping of the clip.
• FIG. 18 to 27 illustrate a staple loader mechanism and the loader loading mode.
• This new process calls for the use of metal micro-staples allowing micro-anastomoses for vessels from 3 to 0.5mm in diameter. These staples have a configuration perfectly suited to the anastomosis of these micro-vessels.
• the clamp Two possible executions of the clip are also shown in Figure 3.
• the clamp, its operation and use are described below.
• the invention includes a new method of anastomosis, a staple designed to be able to remain in the human organism and adapted as regards its forms and its execution, the needs for storage on chargers as well as the requirements for handling and crimping by the mechanisms of a clamp specially studied for the installation of this clip, the clamp also forming part of this invention. Easily usable under a microscope, the forceps are fitted with an interchangeable charger comprising several staples.
• a new staple can be replaced in cells provided at the end of the branches of the clamp by a simple and rapid manipulation of a button placed at the rear of the clamp.
• the exchange of the chargers is done using a special pin screwing into the charger and avoiding having to handle the charger with the fingers, thus preserving its sterile state.
• the crimping of the staples can be preset by means of a special button placed on the top of the clamp.
• the crimping thus adjusted is independent of the movement and the pressure that the operator exerts with his index finger on the lever provided for crimping, at the upper front part of the pliers.
• the operator causes the branches of the forceps to move apart, which move away from the staple set in the tissues, and allow the forceps to be removed without risk of tearing off the staple.
• the staple is gripped in cells adapted to its shape and provided at the end of the branches of the clamp and can be easily approached from its point of application thanks to the great length of these branches. Its attachment in the tissues is easy for an average operator. The crimping itself is very fast and takes only a few seconds. The speed and security of the staple installation are important factors in this kind of intervention.
• the internal mechanisms of the clamp can easily be removed by hand, by unscrewing a nut on the back of the clamp and pulling the terminal button. They are easily disassembled by hand to allow cleaning and complete sterilization.
• the pliers can be reused at will.
• Three sizes of staples can be used with the same pliers; just change the branches of the pliers, which is done by hand.
• Three models of magazines are provided, corresponding to each size of clip; they are also interchangeable.
• Sterilization can be done at high temperature or gamma rays.
• the pliers can be used without modification by a left-handed person or a right-handed.
• the forceps are in the form of a rectilinear body, the handle 1 (fig. 1) being able to be grasped by the operator in the same way as a pen.
• On either side of the handle 1 are grooved portions 2 which facilitate gripping of the clamp.
• Movable branches 3 protrude from the handle at the front of the clamp. They make it possible to hold at their ends a micro-clip (fig. 2 and 3), which can thus be approached to the parts to be sutured in a restricted operating field.
• the micro-clip 4 (fig.
• 3) is characterized by a C shape which can vary a little with each size of clip, and broken down into a central part 4a and two branches 5. It is constituted, for example, by a flat ribbon of rectangular section.
• Each end of the staples of the staple has a pair of claws 6 whose dimensions are very precise despite the very small dimensions of the staple (for example: 0.4mm wide for 0.1mm thick; the crimped staple falling within a circle of about 1mm in diameter).
• the claws can be double, as for version 6, or single, as for version 7 (fig. 3), which is a possible execution for the smallest executions of micro-staples (eg 0.08mm of thickness for 0.25mm section width).
• the tips of the claws are truncated by inclined planes 8 (fig. 3) in order to eliminate a claw end which is too sharp, too fragile and which would be too sharp.
• buttons 9 (fig. 1). It is used to control the refilling of a new clip in the ends of the branches 3.
• a nut 10 retains a bottom 11 closing the handle (fig. 4).
• This bottom has a bayonet locking system in which the pins 12 of the button 9 are housed (fig. 4).
• This bayonet closure keeps a plate 13 in place by pressing the button 9 exerted on the rod 14, integral with the plate 13 (fig. 4).
• mechanisms which have the following functions:
• the plate 13 supports the clamp system, ie its two branches 3 and the mechanism which controls the supply of the clamps with staples (fig. 4, 5, 6, 7, 8, 9, 10).
• the parts 22, 23, 24 are integral with the two tie rods 25.
• the sockets 26 and the part 27 are sliding on the tie rods 25.
• the sockets 26 serve to support the two springs 27a and are pressed against the part 28 of the body 29 (fig. 4, 12).
• the springs 30 push the part 27 against the sockets 26.
• an oscillating lever 31 Under 'of the plate 13 is an oscillating lever 31, receiver in its front portion 31a of a loader 32 carrying a series of staples 33, and in its middle portion, a staple pusher 34 (fig. 4, 5, 6, 7, 8, 9, 10). Controlled by the cam 35 of the part 36, the lever 31 brings the magazine and the series of staples which it carries in the position where the supply of a new staple can be made (fig. 5, 6). The lever 31 and the pusher 34 oscillate around the axis 37, fixed in the lower part of the handle 1 (fig. 4, 5, 6, 12).
• the mechanisms B, C, E, are mounted on the body 29 (fig. 4, 5, 6, 12), outside the handle, then the assembly is inserted in the central bore of the handle 1 (fig 12) by its rear opening.
• the body 29 is then locked in place by the bottom 11 and the nut 10 screwed onto the body 29.
• the body 29 has grooves 43 in which the plate 13 slides, controlled by the rod 14 and the button 9 that the operator manipulates to reload the clamp (fig. 7, 8, 10, 12).
• the two arms 3 of the pliers protrude at the front of the handle through an opening provided for this purpose.
• the plot of the relative movement 49 shows that the inclined planes 47a of the part 47 firstly cause the pivots 45 to move apart in the first part of the movement, and bring the front ends of the branches 3 closer together, the latter pivoting around their axes 50 housed in the plate 13 (fig. 7, 14, 16).
• the position of the front ends of the branches 3 is then that of FIG. 14, thus showing that the crimping of the clip 4 was carried out by this movement.
• Continuing the relative path 49 we then see a median zone where the pivots do not move, followed by a final zone where the relative displacement 49 causes the pivots 45 to come together by the action of the faces 48 of the part 17 in their oblique part (fig. 16).
• the front ends of the branches 3 are then separated, their situation corresponds to FIG. 15.
• the two branches 3 being distant from the clip 4, the operator can bring the clamp back without touching or tearing off .. the clip he has just placed, maintaining the pressure he exerts with his index finger on the lever 16. After which, he can release the pressure of his index finger. We can immediately proceed with the installation of a new clip in the branches of the clamp.
• FIG. 17 A device shown in FIG. 17 is provided for this purpose.
• the part 47 mounted on the part 17 can slide vertically along the arrow 51 (fig. 16), guided by the cylinder 52.
• a spring 53 tends to spread the part 47 of part 17 (fig. 17).
• the pin 54 limits this spacing.
• the part 47 is therefore pressed against the button 55 by the spring 53.
• the button 55 housed in the handle 1 (fig. 1) is locked by a security screw 56 (fig. 1, 16, 17). When the screw 56 is released, the button 55 can be turned according to arrow 57 or vice versa.
• the helical groove 58 then varies the vertical position of the button 55 and of the part 47 relative to the part 17 by bringing it closer or away from it.
• the inclined planes 59 of the part 47 will then modify the relative path 49, forcing the pivots 45 to deviate more or less depending on the vertical position of the part 47.
• This variable spacing allows variable crimping of the clip 4 by the front ends of the branches 3 closing more or less. The operator can therefore choose for himself the crimping of the clip by manipulating the button 55, by rotation. Then he will lock the security screw 56. All the staples he will install will then be crimped in the same way.
• the part 36 slides backwards on the plate 13 by compressing the springs 30 and 72 (fig. 6, 10).
• the cam 35 of the part 36 pushes the cam 69 of the part 34 even further down (fig. 6).
• the lever 31, stopped by the part 66, can no longer move, but the part 34 can still, by compressing the spring 70 even more.
• the front arm of the part 34, carrying the spring leaf 73 moves and the blade presses under the washer 74 forming part of the magazine 32 (fig. 6).
• the facets 75 of these branches at the rear of these, had encountered the cams 38, which had caused the front ends of the branches to spread apart. 3 (fig. 7, 8). This had left at the level of these branches, a free space where could be placed the pivot 67 and the charger with its series of staples 33, as described above.
• the clips, the profile 76 and the pivot 67 are dimensioned in such a way that the clips exert a slight tightening on these parts.
• the staples can slide along these profiles.
• the thrust exerted under the washer 74 by the leaf spring 73 therefore causes the entire stack to rise along the profile 76 and a clip 4 engages on the pivot 67, the height of which is equal to the width of a single clip .
• a single clip will therefore be placed on this pivot 67 (fig. 5, 6, 9, 19).
• the rearward pull exerted on the button 9 is then released and the button 9, the rod 14 and the part 36 are pushed forward by the springs 30 and 72 (fig. 6, 10).
• the washer 74 is provided with a circular spring 77, engaged in a groove formed in the washer 74, as shown in FIGS. 8 and 18.
• This small spring pretended so that its ends exert pressure on either side of the profile 76, serves as a rein for the washer 74 (fig. 18): it keeps it in the position where it has been pushed. the leaf spring 73.
• the two spring ends 77 engage in the bore 78, thus blocking the washer 74 on the profile 76. This avoids losing the washer 74 inside of the clamp (fig 18).
• the pivot 67 has a profile as shown in Figures 18 and 19, having clearances 67a which allow the branches 3 of the clamp to close on it by wrapping the clip by the cells 42 provided in these branches.
• the facets 75 of the branches 3 are then no longer supported on the cams 38 (FIG. 9) and the branches 3, pushed back by the springs 81 move apart and assume the position of FIG. 10.
• the front ends of the branches 3 then have grip the clip 4 placed on the pivot 67 and the clip is now housed in the cells 42 (fig. 8, 10, 18, 19).
• the part 36 and its heel 63 allow the spring 27a to push the part 22 back into its initial position according to FIG. 4.
• This return causes the part 66 to rise in its housing 66a, by the action of the slope 64 on the pins 82 (fig. 4).
• the pivot 67 rises with the part 66 and the clip sliding on its profile, remains retained by the cells 42 (fig. 8, 10, 19).
• the cams 38 then returned to their initial places, pushed back by the springs 38a, because the fingers 41 which held them in the high position also moved forward with the part 36.
• the magazine 32 has a profile 76 on which a washer 74 is threaded.
• a stack of staples is placed above the washer 74.
• a clips 83 sliding on the upper part of the magazine 32, prevents with its tongue 84, that the stacked clips do not escape from the profile 76 ( Figures 18, 21, 22, 23, 26, 27).
• the clip 83 is placed so that its tongue 84 covers the top of the profile 76 (fig. 20, 21, 22).
• the washer 74 abuts, in the opposite direction, on a pin 85 (fig. 18, 20, 21). We cannot therefore lose staples, these being stopped by the tongue 84 and the washer 74.
• the charger 32 is placed, for its manipulation and transport, on a base 86, for example of plastic material, and covered by a cover which can also be of the same material and also transparent. What constitutes its packaging.
• the base and the cover hold together, for example, by a clamp 88 provided at their junction.
• the charger, furnished with its staples, is placed in this packaging after cleaning, for example with ultrasound.
• the cover is put in place and the assembly can be easily sterilized with gamma rays, for example. It is also possible to constitute packages of several chargers in a larger packaging.
• the operator uses a spindle 90 (fig. 23) which he screws into a thread 91 (fig.
• the pins 89 (fig. 22) hold the clips 83 and cause it to slide along the magazine 32 to the position where its tongue 84 has released the top of the stack of staples 33, allowing the rise of this stack along the profile 76, when pushed by the washer 74 and the leaf spring 73, during the recharging movement (fig. 25).
• the spring 94 is bent downwards (fig. 25) and lets pass the charger 32 which will abut against the pin 95.
• the operator unscrews the spindle 90 while maintaining a slight pressure against the magazine, allowing the spring 94 to take its initial place and to retain the magazine 32 by its vertical face (fig. 25).
• the cover 92 With the spindle removed, the cover 92 is returned to its place and the clamp is ready to operate.
• the charger is held rigorously in place by the forms 96, the pin 95 and the heel of the spring 94 (fig. 23, 25, 27).
• the clip 83 slides along the loader 32 and its tongue 84 comes again to cover the top of the stacking of staples 33. This avoids losing staples if there are still some left on profile 76 of the charger.
• the withdrawal movement of the charger itself is stopped by the pins 97 abutting the end of the recess 98 (fig. 24, 26).
• the operator then releases the magazine according to arrow 99 (fig. 23), using the spindle 90 and takes the magazine out of the clamp. If there are still staples remaining on the charger, it puts it back on its base 86, removes the pin 90 by unscrewing it, and covers the base with the cover 87.
• the assembly can be re-sterilized if necessary.
• the part 100 is a cover which closes the underside of the handle; it is retained by a dovetail assembly sliding along the handle and is removable if necessary (fig. 1, 4, 12).

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• Health & Medical Sciences (AREA)
• Life Sciences & Earth Sciences (AREA)
• Surgery (AREA)
• Heart & Thoracic Surgery (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
• Medical Informatics (AREA)
• Molecular Biology (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Surgical Instruments (AREA)

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• 1993
  • 1993-03-18 FR FR9303337A patent/FR2702647B1/fr not_active Expired - Fee Related
• 1994
  • 1994-03-18 HU HU9403608A patent/HUT69016A/hu unknown
  • 1994-03-18 JP JP6520723A patent/JPH07509391A/ja active Pending
  • 1994-03-18 US US08/343,424 patent/US5702048A/en not_active Expired - Fee Related
  • 1994-03-18 EP EP94910440A patent/EP0645983A1/fr not_active Withdrawn
  • 1994-03-18 WO PCT/FR1994/000302 patent/WO1994021181A1/fr not_active Application Discontinuation
  • 1994-12-16 RU RU94046363/14A patent/RU94046363A/ru unknown

Non-Patent Citations (1)

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