Subcutaneous suturing device for closing abdominal wall port of a patient

DESCRIPTION

INSTRUMENT ALLOWING TO CLOSE AN OPENING IN THE ABDOMINAL WALL OF A PATIENT THROUGH SUBCUTANEOUS SUTURE

The present invention relates to an instrument for subcutaneously closing a hole in the abdominal wall of a patient.

When surgery is performed by laparoscopy, the patient's abdomen is inflated with gas and the surgeon operates through trocars.

A trocar is a cylindrical device that crosses the abdominal wall of the patient and through which the instrument (s) enabling the surgical intervention to be introduced.

For placement of these cylindrical trocars, which may have a diameter of between 5 and 15 mm, a skin incision must be made and the trocar inserted into the abdomen through the tip containing tip and protective elements. At the end of the surgery, the trocar is removed and the hole through which it was introduced, with a length of about 12 mm, must be closed again for good healing. In the case of passing holes for trocars exceeding 10 mm in length, they must be closed by suturing the subcutaneous plane, ie the aponevrose and muscle, which corresponds to the rigid rigid part. To date, such holes have been closed by means of a suture at the level of superficial or deep aponevrosis, depending on the thickness of the patients' abdominal walls. The main difficulty in performing this type of suture is to move away from the most superficial part of the skin and look for the muscle plane and aponevrosis, which corresponds to the most rigid tissue on which the suture is to be made, which is tied. from the outside to the inside. Surgeons often have difficulty closing deep tissue composed of aponevrosis and sometimes this tissue is not closed again. In addition, certain complications such as non-healing and non-closure of the deep hole may arise, which may cause events. Another complication that may arise concerns the incarceration of intra-abdominal elements such as the small intestine inside this hole, with the risk of causing intestinal occlusions or other digestive complications.

US 5 320 632 describes a surgical instrument with the characteristics set forth in the preamble of claim 1.

According to this known instrument, the needle support element is composed of two parts which can be spaced apart on either side of the cannula end under the action of the plunger and meeting the spring return force. extending transversely through the cannula and whose two ends are joined respectively to the two needle supporting parts.

The present invention aims to solve the above problems by proposing an instrument for effectively closing a hole in the abdominal wall of a patient in order to obtain a good healing of said hole.

For this purpose, the invention proposes an instrument composed of the characteristics set forth in the characterizing part of claim 1.

Preferably, the plunger is a central rigid sliding rod guided in the extraction device, the lower end of which is attached to the needle support member, the upper end portion passing through an upper cannula closing transverse wall, the stem being possible. be axially fixed to the cannula by means of a locking device which can be manually unlocked so as to exert an axial force of retraction of the needles on the cannula on the support element, to allow it to be inserted into the hole, after which the operator can unlock the locking device to move the stem in a direction that extends the support member and the needle outlet out of the cannula.

The extraction device is composed of a cylindrical sliding upper part in the cannula, a smaller diameter cylindrical lower end portion into which the lower end portion of the rod is slidably mounted and a joint intermediate portion made up especially of two. oblique walls that converge to the lower end, each having a longitudinal window which allows, with the extraction device in the low position, the corresponding needle passage to its projecting position out of the cannula, each window terminating above the lower part of the extraction device in two V-shaped flanges to which the hooked end of the needle can be attached when the extraction device is moved towards the upper part of the cannula.

The extraction device further comprises two diametrically opposed external gripping jaws, joined to the upper part of this element and projecting radially through two longitudinal cannula sidewall windows, situated over the needle passageways, and a pre-spring is mounted. tensioned between the extraction device and the cannula in order to return the extraction device to its low position.

The needles are curved and are respectively in two planes parallel to the longitudinal intermediate plane of the cannula, disposed on both sides of this intermediate plane at the same distance from it so as to allow the needles to occupy their retracted position by crossing each other. on the end portion of the cannula.

The needles are removably mounted at their opposite ends to the hooked ends on two bases of circular, triangular or other cross-section and joined to the ends of the support member, the axis of each base being angled with respect to the base. support plane of the corresponding end of the support member to facilitate extraction of the needles during upward movement of the extraction device in the cannula.

The needles are introduced into the abdominal wall and, once placed in the projecting position relative to the cannula under the same wall, exert traction on the cannula, which makes them penetrate the wall and then exert an effort towards the plunger. retract the needles towards the cannula and penetrate the needles into the orifice and cannula through two diametrically opposed windows.

The two planes containing the two needles are on either side of the piston rod.

According to one embodiment, the support element is composed of a flexible blade that supports the two needles at their ends and is held at the bottom of the cannula, perpendicular to the longitudinal intermediate plane of the latter, by two pairs of axes of parallel to the blade, disposed on either side of the transverse median plane of the blade, symmetrically therein, and joined to the cannula body perpendicular to its longitudinal intermediate plane, the two axes of each pair being on each side of the blade immediately adjacent thereto in order to flexibly modify the radius of curvature of the blade by sliding the blade between the bearing axes under the action of the piston rod whose end The lower part is attached to the geometric center of the blade, and to move this center up or down the cannula for the purpose of withdrawing, re-introducing and then partially inserting the needles into the cannula.

According to another embodiment, the support member is comprised of two arms mounted to oscillate about a common central axis attached to the cannula body at the bottom of the cannula and extending perpendicular to the longitudinal intermediate plane of the cannula. whereas the opposite ends of the two arms support the needles and the plunger controls the simultaneous oscillation of the two arms, moving them down or up to retract or reinsert the needles into the cannula through two pull arms joined together at the lower end of the piston rod by a pivot shaft attached to the piston parallel to the shaft oscillating the needle support arms and, on the other hand, at their opposite ends pivotally with respect to the two support arms adjacent the needles.

The stem locking device, in its bending position of the support member, contains two diametrically opposed protrusions attached to the top of the stem, projecting radially outwardly and abutting above or below the transverse wall. cannula closure, depending on whether the support element is made up of the flexible blade or the two swing arms, wherein this wall has a defined oblong hole on either side of the central rod through hole, allowing the two protrusions to pass through it by rotating the top of the rod relative to the bottom to unlock the rod and displace it. axially in the cannula.

For a better understanding of the invention and other purposes, features, details and advantages thereof, an explanatory description is given below with reference to the accompanying schematic drawings, which are merely exemplary and illustrative of two embodiments of the invention, and in which: :

Figure 1 is an exploded perspective view of the instrument according to the invention introduced through the abdominal wall of a patient;

Figures 2 to 8 represent the instrument of Figure 1 at different stages of operation for subcutaneously closing a hole in the abdominal wall of the patient;

Figure 9 is a further embodiment of the needle support member integrated in the hole closure instrument in its extended position;

Figure 10 is a view of the support element of Figure 9 in the retracted position; and

Figure 11 is a top view according to the arrow XI of Figure 9.

Referring to Figures 1 to 8, the instrument according to the invention is intended to allow subcutaneous closure of a hole 1 through the abdominal wall 2 of a patient for passage of a trocar previously used in a laparoscopic surgical procedure .

The instrument contains a rigid cylindrical cannula 3, for example made of metal, which can be partially inserted into hole 1 immediately after the trocar has been collected and after the surgical procedure is completed, ie at a time when the patient's abdomen is still inflated with a gas suitable for that purpose.

Figure 1 represents the instrument in its initial position of introduction through the hole 1 of the abdominal wall 2 and in which the lower end portion 4 of the instrument is located in the abdomen under the wall 2.

The instrument further includes a rigid cylindrical rod-shaped central piston 5 extending into the cannula 3 and which can be manually actuated from the outside of the cannula 3 via an external gripping handle 6 which slides it axially and guided regarding the cannula as will be described below.

The instrument also contains two needles 7 removably attached to the diametrically opposite ends of a support member 8 consisting of a flexible blade resting on the lower end portion 4 of the cannula 3. For this purpose the flexible blade 8 is held in part 4 perpendicular to the longitudinal intermediate plane of the cannula 3 by two pairs of bearing shafts 9 parallel to the blade 8 and disposed on either side of the transverse intermediate plane of the blade, symmetrically to this plane. . The support axes 9 are joined to the lower body 4 of the cannula 3, perpendicular to the longitudinal intermediate plane of the cannula, the two axes 9 being

<td>of each pair</td><td>situated in</td><td>both</td><td>the sides of the blade</td><td> 8,</td>

<td>immediately</td><td>adjacent to</td><td>same</td><td>, apart from each other</td><td>to</td>

<td>length of</td><td>blade 8.</td><td></td><td></td><td></td>

<td>The edge</td><td>bottom of</td><td>stem</td><td>of plunger 5 is joined</td><td>per</td>

<td colspan="2">any suitable element</td><td>, per</td><td>example a screw</td><td>in</td>

attachment to the geometric center of the support blade 8 so that an upward displacement of the cannula 3 of the rod 5 causes an elastic deformation of the blade 8 by sliding the latter between the pairs of support shafts 9 to displace the portions of opposite ends of the blade 8 through, respectively, two rectangular longitudinal windows 10 diametrically opposed and arranged through the sidewall of the body of the lower end portion 4 of the cannula 3, so that the two needles 7 protrude completely out of the end portion 4 as shown in figure 2. A downward displacement of the plunger rod 5 from its position shown in figure 2 causes bending deformation of the blade 8 towards the lower end of the cannula 3 and the slide 8 of the blade between the two pairs of bearing shafts 9, which deform the blade 8 so that its end portions can re-enter the end portion 4 of the cannula 3 through the two windows 10 as shown in figure 7.

The piston rod 5 is locked in its initial position shown in Figure 1 by a manually unlockable locking device, composed of two protrusions 11 attached to the rod 5 in respective upper part 5a, which project from it and are diametrically opposite. The two protrusions 11 may occupy a position transverse to an opening 12 made through the circular closure wall 13 of the upper end of the cannula 3 and under which the two protrusions 11 are supported under the action of the elastic reaction force exerted by the blade 8. the rod 5. The upper part 5a of the rod 5 can be rotated with the help of the handle 6 relative to the lower part 5b thereof by about 90 ° in order to place the two protrusions 11 perpendicularly to the opening 12 to unlock the rod 5 of the cannula 3 and allowing the traction to be exerted on the rod 5, causing the blade 8 to move in a direction that exits the needles 7 of the end part 4 through the two windows 10. As can be seen especially from FIG. 4, the upper part 5a of the rod 5 has at its end a circular head 5al of lower diameter fixed in a reciprocating recess 5bl existing at the lower end 5b of the rod 5 opposite the blade. 8 to allow rotation of the upper part 5a relative to the lower part 5b of the rod 5. The head 5al may be composed of a screw head whose threaded part is locked by bolting to the lower end of the rod part 5a coaxially to the latter.

Each needle 7 is mounted on the corresponding end of the blade 8, on a base 14 joined to the end of the blade 8 and provided with a cross-section which may be circular, triangular or otherwise. The axis of each base 14 is angled relative to the support plane of the corresponding end of blade 8 to facilitate extraction of needle 7 as will be described below. Alternatively, and to further facilitate the extraction of each needle 7, each base 14 may have an axis perpendicular to the corresponding end plane of blade 8, but have a free end face inclined relative to this end plane so wherein the end of the needle 7 engaging the base 14 has a guard portion that rests on said angled face.

The needles 7 are identical, curved and facing each other and are respectively in two planes parallel to the longitudinal intermediate plane of the cannula 3, disposed on both sides of this plane at substantially equal distance from it, these two planes being equally parallel on both sides of the plunger rod 5 so as to allow the needles 7 to occupy their retracted initial position, intersecting at the end portion 4 of the cannula 3. According to the illustration in Figure 2, the needles 7 are above the blade 8. The needles 7 terminate in a pointed hook 7a.

The instrument further includes a needle extraction device 15 slidably mounted to the cannula 3, concentrically to the rod 5, which can be maneuvered from the outside to move it from a low position on the end portion 4 of the cannula 3, as shown. 1 to 4, to an elevated position at the top of the cannula 3, shown in figure 8, so as to simultaneously lock during this displacement; the two needles 7 previously inserted into the abdominal wall 2, obliquely penetrating each other into the hole 1 and the cannula 3 through the longitudinal windows 10 and extracting the needles 7 from the flexible blade 8 to push them upwards into the cannula 3.

Thus, the extraction device 15 is composed of a cylindrical upper portion 16 which can slide along the corresponding inner lateral surface of the cannula 3, a smaller diameter cylindrical lower end portion 17 into which the lower portion is slidably mounted. lower part 5b of the rod 5, and a connecting intermediate portion consisting of two opposite walls 18 situated on either side of the rod 5, each wall 18 having a straight portion 18a parallel to the rod 5 and an oblique portion 18b that converges to the lower end portion 17. Each wall 18 has a longitudinal window 19 allowing the corresponding needle 7 to pass through and terminating above the lower part 17 of the extraction device 15 in two V-shaped edges 19a at the bottom of which the end can be engaged. hook 7a of needle 7 during movement of the extraction device 15 to the top of the cannula 3. Like needles 7, windows 19 are also spaced from the longitudinal intermediate plane of cannula 3.

In order to allow the upper part 5a of the rod 5 to be rotated relative to its lower part 5b during the cannula 3 rod release operation 5 from its initial position shown in figure 1, the lower part 5b may be splined by engaging sliding shape in the corresponding splined milling of the lower part 17 of the extraction device 15. However, this arrangement is not mandatory since the rod end assembly 5, the blade 8 and the axes 9 keep the lower part 5b of the rod 5 rotating relative to the cannula.

The extraction device 15 further comprises two diametrically opposed outer gripping jaws 20, joined to the cylindrical upper part 16 and projecting radially through two longitudinal windows 21 of the cannula side wall 3, which are above the passing windows 10 Needles 7.

The extraction device 15 is pulled to its lower position in the cannula 3 by a compression coil spring 22 pre-tensioned between the upper closing wall 13 of the cannula 3 and an internal transverse wall 23 of the extraction device 15, located in the cylindrical upper part 16 thereof. Wall 23 has a circular central hole 24 through which rod 5 passes.

A suture 25 is joined by the two free ends to the two needles 7 opposite the respective hooked ends 7a and of sufficient length to constitute a loop 25a situated, since the introduction of the instrument on the abdominal wall 2, on the outside. it is held outside until the instrument is retracted from wall 2. Each end of the wire 25 may be fixed to the corresponding metal needle 7 by crimping.

The lower part 4 of the cannula 3 has a bulging end where the blade support axes 9 are located so as not to cause injury.

The operation of the instrument can now be understood from the foregoing description and is explained below.

In the initial conditions of use of the instrument, the extraction device 15 occupies its lower position in the cannula 3 by the return spring 22 and the two jaws 20, respectively supported on the two lower edges of the two windows 21 of the cannula 3, and the stem 15 is locked at its lowest position in cannula 3 so as to exert pressure on blade 8 to maintain the ends of blade 8 and the two needles 7 within end portion 4 of cannula 3, as shown in figure 1.

The instrument is then inserted into hole 1 through wall 2 until the lower extremity part 4 is located in the abdomen under wall 2. This maneuver is performed immediately after the trocar used previously for laparoscopic surgery with the abdomen was extracted. still inflated by gas to prevent injury to the internal organs. When the instrument is introduced through the abdominal wall 2, the surgeon must be careful to maintain the loop 25a of the wire 25 outside the patient's body by passing the wire end portions into hole 1 and through each of the two windows. 10 of end portion 4.

Then the stem 5 is unlocked from the cannula 3 by rotating the upper part 5a with the aid of the handle 6 until the two protrusions 11 are perpendicular to the opening 12 and the surgeon begins to pull on the stem 5 to move to the upper part. from the cannula 3 the geometric center of the blade 8 and, by sliding it between the two pairs of bearing shafts 9, swing the two ends of the blade 8 and the two needles 7, away from each other until they reach the position shown in figure 2, in which the two needles 7 are just below the inner face of the abdominal wall 2. Thus, the two needles 7 are offset in their parallel planes in a crossed position from both sides of the rod 5, shown in figure 1, to the position shown in figure 2, passing through the windows 19 of the extraction device 15 and the windows 10 of the end portion 4 of the cannula 3.

From the position shown in figure 2, the surgeon exerts an upward pulling force on the instrument to introduce the needles 7 into a thick part of the abdominal wall aponevrose 2, as shown in figure 3.

The surgeon then compresses the rod 5 into the cannula 3 so that the lower end of the rod 5 bends by bending the blade 8, which slides between the two pairs of shafts 9 and the needles 7 completely cross the thickness of the rod. abdominal wall 2 to engage the cannula 3 through the windows 10 of the end portion 4 of the cannula 3 and the windows 19 of the extraction device 15 as shown in figure 4.

The surgeon then moves the extraction device 15 to the upper part of the cannula 3 with the help of the two outer jaws 20 until the jaws 20 are aligned with the corresponding upper edges of the two windows 21 of the cannula 3, as shown in Figure 5. This figure shows that, while moving to the upper part of the extraction device 15, the lower V-shaped edges of the two windows 19 grasped the hooked ends 7a of the needles 7 to release them from their bases 14, with the end portions of the thread 25 pulled by the needles in the cannula 3 through the two windows 10. Figure 5 also shows that the two bases 14 are just under the abdominal wall 2.

The surgeon then pushes the instrument to place the lower end portion 4 of the cannula at a certain distance from the abdominal wall 2 (Figure 6) and to allow, under pressure on the plunger rod 5, the curvature of the flexible blade 8 to respective end portions re-enter the end portions 4 without needles as shown in Figure 7. The surgeon maneuvers the handle 6 to rotate the upper part 5a of the rod 5 relative to its lower part 5b and place the two protrusions 11 in lock position of the rod 5 below the upper cannula closure wall 3.

Finally, the instrument is fully withdrawn from hole 1, as shown in 8, and the thread 25 attached to the needles 7 is pulled to continue to pass through the thickness of the abdominal wall 2 along the same path as the needles 7, until loop 25a is substantially at the bottom of hole 1, at the level of the inner face of abdominal wall 2. It is then sufficient for the surgeon to sever the two end portions of the wire 25 and manually knot the two ends of the wire to join and close the walls in alignment with hole 1, including the aponevrose and deep muscle plane, with tension of the part of the wire loop under the wall 2.

Figures 9-11 illustrate another embodiment of the needle support element 7 which may be used in place of the support element consisting of the flexible blade 8 of the first embodiment.

According to this second embodiment, the support element is composed of two arms 26 mounted to oscillate about a common central axis 27 joined to the cannula body by the underside 4 of the cannula and extending perpendicular to the plane. longitudinal intermediate of the cannula. 0 The shaft 27 can be fixed by its ends respectively mounted under pressure in two opposite coaxial holes drilled in the side wall of the end portion 4 of the cannula 3, the two arms 26 oscillatingly mounted on the shaft 27 to form a hinge. of articulation 28.

The two arms 26 include, in union with their opposite ends, the two bases 14 on which the two needles 7 are removably mounted. In order to allow the two bases 14 to be situated in the two planes spaced apart and parallel to the longitudinal intermediate plane of the cannula 3, the two arms 26 present, when viewed from the bottom, an elongated S-shaped configuration whose curved branches are of both sides of axis 27 with the two bases arranged diagonally across the geometric center of axis 27.

The piston rod 5, identical to the rod 5 of the first embodiment, controls the simultaneous oscillation of the two arms 26 by two traction arms 29 joined on either side to the lower end of the rod 5 by an axle. 30 is attached to the rod parallel to the oscillating axis 27 and, on the other hand, to their opposite ends pivotally with respect to the two support arms 26, next to the needle support bases 14.

When the instrument is introduced through the abdominal wall 2, the two arms 26 occupy the position illustrated in figure 10, in which the two arms are raised above the pivot axis 27, defining an acute angle to accommodate the end portions of the arms. 26 and the corresponding needles 7 in the lower end portion 4 of the cannula 3.

To extend the two arms 26 in their projected opening position through the windows 10 of the lower part 4 of the cannula 3, the surgeon exerts downward pressure on the piston rod cannula 5 so that the two pulling arms 29 oscillate. the two arms 26 about the axis 27 away from each other until they reach the position where the needles 7 are under the wall 2, as shown in figure 2.

For the rest, the principle of operation of the instrument fitted with the support element according to the second embodiment is identical to that described above with respect to the first embodiment except that it is necessary to exert pressure on the stem of the plunger 5 to bring the needles into the projecting position out of the cannula 3 and pull the rod 5 to bend the two arms 26 closer to each other, and housing them without needles at end portion 4 of cannula 3 prior to complete extraction of the instrument from hole 1. The other difference from the first embodiment is that the release of the rod 5, especially in the housing position of the arms 26 and the needles 7 at the end part 4 prior to the introduction of the cannula into the wall 2, is effected. placing the two locking protrusions 11 on the upper closing wall of the cannula 3 transversely of the opening 12 and, to facilitate the extension of the two arms 26 in the position shown in figure 9, It is possible to place a coiled torsion spring on the oscillating axis 27 and exerting an elastic strain on the two arms 26 which tends to move them apart and to keep them in the stretched position.

The instrument according to the invention effectively closes the trocar passageway and sutures the muscle and aponevrose of a patient's abdominal wall.

By way of indication, the instrument may have a length of about 20 cm, with a maximum external diameter of 12 mm at the level of the bulging part, the diameter of the cannula along its two thirds being 10 mm in length. In the projecting position with respect to the flexible blade 8 or needle support arms 26, their ends may extend beyond the lower end portion 4 of the cannula 3 between 5 mm and 7 mm on either side of it. Of course, these dimensions are merely exemplary and not limiting.

REFERENCES REFERRED TO IN THE DESCRIPTION

The list of documents referred to by the author of this patent application is for the reader's information only and is not part of the European patent document. Notwithstanding its careful preparation, the IEP assumes no responsibility for any errors or omissions.

Patent documents cited in the description • US 5320632 A [0005]