Subcutaneous suturing device for closing abdominal wall port of a patient

The present invention relates to an instrument for closing by subcutaneous suture a hole made in the abdominal wall of a patient.

Where surgery is performed laparoscopically, the patient's abdomen is inflated with gas and the surgeon operates through trocars.

A trocar is a cylindrical device which passes through the patient's abdominal wall and through which are introduced the one or more instruments to perform the surgery.

To implement these cylindrical trocars, which may have a diameter of 5 to 15 mm, it is necessary to make a skin incision and the trocar is inserted into the abdomen through its end provided with a tip and protection means . At the end of surgery, the trocar is removed and the orifice through which it was introduced, having a length of about 12 mm, must be closed for proper healing. For trocars passing holes having a length greater than 10 mm, it is necessary to perform closure by suturing subcutaneous plane, that is to say of the fascia and muscle which is the part resistant rigid. Heretofore, such openings were closed by placing a stitch at the superficial or deep fascia according to the thickness of the abdominal wall of patients. The major difficulty to achieve such a stitch is to remove the skin, the most superficial part, and pick-muscle and fascia which is the most rigid fabric which must put the stitch which will be established from the outside to the inside. Surgeons often have difficulty closing the deep tissue and the fascia that is sometimes this fabric is not closed. Furthermore, certain complications may follow, such as non-healing and non-closure of the deep hole, which may cause hernias. Another complication may arise regarding the incarceration of intra-abdominal elements such as for example the small intestine within this hole with may cause bowel obstruction or other digestive complications.

<patcit id="pcit0001" dnum="US5320632A"><text>US 5320632</text></patcit> discloses a surgical instrument having the features of the preamble of claim 1.

According to this known instrument, the needle support member consists of two parts which can be moved apart from each other on either side of the end of the cannula under the piston action and the against the return force of a spring extending transversely through the cannula and whose two ends are connected respectively to the two portions of needle holder.

The present invention aims to solve the above problems by providing an instrument to effectively close an orifice in the abdominal wall of a patient to allow proper healing of this hole.

To this end, the invention provides an instrument comprising the features stated in the characterizing part of claim 1.

Preferably, the plunger is a central rigid sliding rod guided in the extraction means and whose lower end is connected to the needle support member and the upper end portion through an upper transverse wall for closure of the cannula, the rod being axially retained in the cannula by means of a manually releasable locking so as to exert on the support member an axial force retraction of the needles in the cannula to allow introduction thereof into the hole, the operator can then unlock the locking means for moving the rod in a direction causing the deployment of the support member and the outlet of the needles of the cannula.

The extracting means comprises a cylindrical upper part sliding in the cannula, a lower cylindrical end portion of smaller diameter in which is slidably mounted the lower end portion of the rod and an intermediate connecting portion consisting especially two oblique walls converging towards the lower end portion and each including a longitudinal window allowing, in low position of the extraction means, the passage of the corresponding needle to its extended position projecting from the cannula, each window terminating above the lower part of the extraction medium by two edges V-shaped in which can engage the hook-shaped end of the needle during the displacement of the extraction means towards the top of the cannula.

The extraction means further comprises two external lugs diametrically opposed gripping integral with the upper part of this means in radially projecting respectively through two longitudinal windows in the side wall of the cannula located above passage windows needle and a spring is mounted prestressed between the extraction means and the cannula to return the extraction means to its lower position.

The needles are curved and situated respectively in two planes parallel to the longitudinal median plane of the cannula disposed on either side of said midplane equidistant from the latter so as to allow the needles to occupy their retracted position in crossing each other in the end portion of the cannula.

The needles are mounted detachably at their opposite ends to those hook-shaped respectively in two bases with a circular cross section, triangular, or other, and secured to the ends of the support member, the axis of each base being inclined relative to the corresponding end support plane of the support member to facilitate extraction of the needles during the ascent of the extraction means in the cannula.

The needles are inserted into the abdominal wall, once occupying their position output of the cannula below this wall, by pulling on the cannula to make them penetrate into the wall and then by exerting on the piston a force in a direction for retracting the needles towards the cannula and smooth due ends thereof into the hole and into the cannula through the two diametrically opposed windows thereof.

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

According to one embodiment, the support member is constituted by a flexible blade carrying at its ends the two needles and maintained in the lower portion of the cannula perpendicular to the longitudinal median plane of the latter by two pairs of parallel support shafts to the blade, disposed on either side of the transverse median plane of the blade symmetrically thereto and integral with the body of the cannula perpendicular to its longitudinal median plane, both pins of each pair being located on either side of the adjacent blade thereof to change by bending the blade radius of curvature by sliding it between the support pins under the action of the piston rod, whose lower end is integral with the geometrical center of the blade, and move to the center down or up the cannula to extend or retract, and later partially return the needles or cannula.

According to another embodiment, the support member is constituted by two pivoting arms mounted on a common central axis integral with the cannula body in the lower part thereof and extending perpendicularly to the longitudinal median plane of the cannula, the opposite ends of the two arms carrying the needle and the piston controls the simultaneous pivoting of the two arms by moving it downwards or upwards to extend or retract the needles to or within the cannula by means of two traction arms connected firstly to one another at the lower end of the piston rod by a pivot articulation integral with the plunger parallel to the pivoting axis of the needle support arm and the other to their opposite ends in an articulated manner to the two support arms respectively, in the vicinity of the needles.

The stem of the locking means to its deployment position of the support member comprises two diametrically opposite lugs integral with the upper part of the rod projecting radially therefrom and bearing under or on the transverse wall closing the cannula following that the support member is constituted by the flexible strip or the two pivoting arms, said wall having a slot defined on either side of the central orifice passage of the rod and allowing passage the two pins through it by rotation of the upper part of the stem relative to its lower portion to unlock the rod and move it axially in the cannula.

The invention will be better understood and other objects, features, details and advantages thereof will appear more clearly in the explanatory description which will follow with reference to the accompanying schematic drawings given solely as an example illustrating two modes embodiment of the invention and in which:<ul><li>the <figref idrefs="f0001">figure 1</figref> is an exploded perspective view of the instrument of the invention inserted through an abdominal wall of a patient;</li><li>the <figref idrefs="f0002 f0003 f0004 f0005 f0006 f0007 f0008">Figures 2-8</figref> represent the instrument of <figref idrefs="f0001">figure 1</figref> in different operating phases for closing by subcutaneous suture a hole made in the patient's abdominal wall;</li><li>the <figref idrefs="f0009">9</figref> shows another embodiment of the support member of the needle forming part of the closure tool of the orifice and being in its extended position;</li><li>the <figref idrefs="f0009">Figure 10</figref> is a view of the support member of the <figref idrefs="f0009">9</figref> in deployed position; and</li><li>the <figref idrefs="f0009">11</figref> is a top view according to the arrow XI of <figref idrefs="f0009">9</figref>.</li></ul>

Referring to <figref idrefs="f0001 f0002 f0003 f0004 f0005 f0006 f0007 f0008">Figures 1 to 8</figref>The instrument of the invention is intended to allow the subcutaneous suture closure with a hole 1 performed through an abdominal wall 2 of a patient for the passage of a trocar having previously used for surgery by laparoscopy.

The instrument comprises a rigid cylindrical cannula 3, for example of metal, which can be partially introduced into the opening 1 immediately after removal of the trocar once the surgery is completed, that is to say at a time when the patient's abdomen is always inflated by a suitable gas.

The <figref idrefs="f0001">figure 1</figref> represents the instrument to its initial insertion position through the orifice 1 of the abdominal wall 2 and on which the lower end portion 4 of the instrument is located in the abdomen below the wall 2.

The instrument further comprises a central piston 5 in the form of rigid cylindrical rod extending coaxially in the cannula 3 and manually operable from the outside of the cannula 3 by means of an external handle 6 for axially guided manner slide relative to the cannula 3 as will be seen later.

The instrument further comprises two needles 7 removably fixed to the diametrically opposite ends of a support member 8 consisting of a flexible blade supported in the lower end portion 4 of the cannula 3. For this purpose, the flexible strip 8 is maintained in the portion 4 perpendicular to the longitudinal median plane of the cannula 3 by two pairs of support shafts 9 parallel to the blade 8 and disposed on either side of the transverse median plane of this blade symmetrically to this plane. The support pins 9 are secured to the body of the lower part 4 of the cannula 3 perpendicularly to the longitudinal median plane of the cannula and the two axes 9 of each pair are located on either side of the blade 8 in the immediate vicinity thereof being offset with respect to one another along the blade 8.

The lower end of the piston rod 5 is secured by any suitable means such as fixing screws, the geometric center of the support plate 8 so that an upward movement of the cannula 3 of the rod 5 causes an elastic deformation of the blade 8 by sliding it between the pairs of support shafts 9 to exit the opposite end portions of the blade 8 through two diametrically opposite longitudinal rectangular windows 10 respectively carried out through the side wall of the body of the lower end portion 4 of the cannula 3, so that the two needles 7 do completely projecting outside of the end portion 4 as shown in <figref idrefs="f0002">2</figref>. A downward movement of the piston rod 5 from its position shown in<figref idrefs="f0002">2</figref> causes blade bending deformation 8 towards the lower end of the cannula 3 and the sliding of the blade 8 between the two pairs of support shafts 9 which deform the blade 8 so that its end portions able to again enter the end portion 4 of the cannula 3 through the two windows 10 as shown in <figref idrefs="f0007">7</figref>.

The piston rod 5 is locked in its initial position shown in <figref idrefs="f0001">figure 1</figref> by a releasable locking means manually and consists of two pins 11 secured to the rod 5 in the upper part 5a thereof protruding therefrom and diametrically opposed. The two lugs 11 can occupy a position transverse to a slot 12 made through the circular wall 13 closing the upper end of the cannula 3 and in which are supported the two lugs 11 under the action of the spring force of reaction exerted by the blade 8 of the shaft 5. the upper portion 5a of the rod 5 can be rotated using the handle 6 relative to the lower part 5b thereof of about 90 ° to bring the two studs 11 in vertical alignment with the slot 12 to unlock the rod 5 of the cannula 3 and allow to exert traction on the rod 5 causing the movement of the blade 8 in a direction causing the needle 7 out of the end portion 4 through the two windows 10. As apparent in particular from the<figref idrefs="f0004">4</figref>, The upper part 5a of the rod 5 has at its end a circular head 5a1 of smaller diameter engaged in a form conjugated 5b1 counterbore formed at the end of the lower part 5b of the rod 5 opposite the blade 8, so as to allow a rotation of the upper portion 5a relative to the bottom portion 5b of the rod 5. the head 5a1 may be formed by a screw head, the threaded part is secured by screwing into the lower end of the portion 5a of the rod 5 coaxially therewith.

Needles 7 are each mounted at the corresponding end of the blade 8 in a base 14 secured to the end of the blade 8 and having a cross section which may be circular, triangular, or other. The axis of each base 14 is inclined relative to the corresponding end support plane of the blade 8 to facilitate the extraction of the needle 7 as will be seen later. Alternatively, always for easy removal of each needle 7, each base 14 may have its axis perpendicular to the corresponding end plane of the blade 8, but have a free end face inclined relative to the end plane so that the tip of the needle 7 engaging the base 14 has a shoulder portion resting on the inclined face.

Needles 7 are identical, curved and directed towards each other, being located respectively in two planes parallel to the longitudinal median plane of the cannula 3, arranged on either side of this plane substantially equidistant from celui- below, these two parallel planes being further located on either side of the piston rod 5 so as to enable the needle 7 to occupy their initial retracted position, folding in the end portion 4 of the cannula 3. the needles 7 are located above the blade 8 by considering the <figref idrefs="f0002">2</figref>. Each needle 7 terminates in a pointed portion shaped hook 7a.

The instrument also comprises means 15 for extracting the needles 7 slidably mounted in the cannula 3 concentrically to the rod 5 and being operable from outside to move it from a lower position in the end portion 4 of the cannula 3, as shown in <figref idrefs="f0001 f0002 f0003 f0004">Figures 1 to 4</figref>, To a high position in the upper part of the cannula 3 shown in <figref idrefs="f0008">8</figref> to grip simultaneously, during this movement, the two needles 7 previously introduced in the abdominal wall 2 penetrating obliquely towards one another in the hole 1 and the cannula 3 through the longitudinal windows 10 and extract the needles 7 of the flexible strip 8 to route upwardly into the cannula 3.

The extracting means 15 thus comprises an upper cylindrical portion 16 slidable along the corresponding inner side surface of the cannula 3, a portion of lower cylindrical end 17 of smaller diameter in which is slidably mounted the lower part 5b of the rod 5, and an intermediate connecting portion consisting of two opposing walls 18 located 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 converging towards the lower end portion 17. Each wall 18 has a longitudinal window 19 allowing the passage of the corresponding needle 7 and ending above the bottom 17 of the extraction means 15, 19a by two shaped edges V in the bottom of which can engage the hook-shaped end 7a of the needle 7 during the displacement of the extraction means 15 to the top of the cannula 3. because the needles 7 are offset from the longitudinal center plane of the cannula 3, the windows 19 are also listed.

To permit rotation of the upper part 5a of the rod 5 in relation to its lower part 5b during the unlocking operation of the rod 5 of the cannula 3 from its initial position shown in <figref idrefs="f0001">figure 1</figref>The lower part 5b may be grooved by committing to slide in the splined bore corresponding to the lower part 17 of extraction means 15. However, this provision is not mandatory, because the group consisting of the end of the rod 5, the blade 8 and the pins 9 keeps rotating the lower part 5b of the rod 5 with respect to the cannula.

The extracting means 15 further comprises two diametrically opposed gripping external lugs 20 integral with the cylindrical upper portion 16 projecting radially through each of two longitudinal windows 21 of the side wall of the cannula 3 and are located au above the windows 10 for passage of needles 7.

The extracting means 15 is returned to its low position in the cannula 3 by a helical compression spring 22 mounted prestressed between the upper closing wall 13 of the cannula 3 and an inner transverse wall 23 of the extraction means 15 located in the cylindrical upper portion 16 thereof. The wall 23 has a circular central opening 24 through which the rod 5.

A suture 25 has its two free ends respectively integral with the two needles 7 opposite their hook-shaped ends 7a and has a length sufficient to form a loop 25a located, from the introduction of the instrument in the abdominal wall 2, on the outside thereof and maintained outside to withdrawal of the instrument of the wall 2. Each end of the wire 25 may be attached to the corresponding metal needle 7 by crimping.

The lower part 4 of the cannula 3 has an enlarged end in which lie the axes 9 of the blade support 8 so as to be atraumatic.

The operation of the instrument is already apparent from the description that was made above and will now be explained.

In the initial conditions of use of the instrument, the extracting means 15 is in its lower position in the cannula 3 by the return spring 22 and two lugs 20 bearing respectively on the two lower edges of the two windows 21 of the cannula 3, and the rod 15 is locked at its lowermost position in the cannula 3 so as to exert on the blade 8 a holding pressure of the ends of the blade 8 and the two needle 7 within the part end 4 of the cannula 3, as shown in <figref idrefs="f0001">figure 1</figref>.

The instrument is then introduced into the port 1 through the wall 2 until the lower end portion 4 is located in the abdomen below the wall 2. This maneuver is performed immediately after the extraction of the trocar used before to the surgery laparoscopically with the abdomen kept inflated by the gas to prevent damage to internal organs. Upon insertion of the instrument through the abdominal wall 2, the surgeon will take care to keep the loop 25a of the wire 25 outside the patient's body with the end portions of the wire passing through the port 1 and respectively passing through both windows 10 of the end portion 4.

Then, the stem 5 is unlocked from the cannula 3 by turning the upper portion 5a by means of the handle 6 until the two lugs 11 come in vertical alignment with the lumen 12 and the surgeon then pulls on the rod 5 to move upwards of the cannula 3 the geometric center of the blade 8 and, by sliding it between the two pairs of support shafts 9, tilting the two ends of the blade 8 and the two needles 7 by removing them from each other to the position shown in <figref idrefs="f0002">2</figref> in which the two needles 7 are located just below the inner surface of the abdominal wall 2. Thus, the two needles 7 have moved in their respective planes parallel to their crossed position on either side of the rod 5 shown in <figref idrefs="f0001">figure 1</figref> to their position shown in <figref idrefs="f0002">2</figref> passing through the windows 19 of the extraction means 15 and the windows 10 of the end portion 4 of the cannula 3.

From the position shown in <figref idrefs="f0002">2</figref>, The surgeon exerts on the instrument a tensile force upwards to introduce the needle 7 in a thickness portion of the apanévrose of the abdominal wall 2 as shown in <figref idrefs="f0003">3</figref>.

Then, the surgeon pushes the rod 5 again into the cannula 3 so that the lower end of the rod 5 folds by bending the blade 8 which slides between the two pairs of pins 9 and needles 7 pass completely through the part of the thickness of the 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 means 15 as shown in <figref idrefs="f0004">4</figref>.

The surgeon then moves to the top of the cannula 3 the extracting means 15 using the two outer lugs 20 until the lugs 20 abut on the respective upper edges of the two windows 21 of the cannula 3 as shown in <figref idrefs="f0005">5</figref>. This figure shows that during the upward movement of the extraction means 15, the lower edges of the V-shaped two windows 19 have seized the hook-shaped ends 7a of the needle 7 to disengage from their respective bases 14 with the end portions of the wire 25 being pulled by the needles in the cannula 3 through the two windows 10. the<figref idrefs="f0005">5</figref> also shows that the two bases 14 lie substantially just below the abdominal wall 2.

The surgeon then pushes the instrument to move the lower end portion 4 of the cannula to a distance from the abdominal wall 2 (<figref idrefs="f0006">6</figref>) And allow, by thrust on the piston rod 5, the folding of the leaf spring 8 until the end portions thereof fall again, without the needles, in the end portion 4 as shown in <figref idrefs="f0007">7</figref>. The surgeon manipulates the handle 6 to rotate the upper part 5a of the rod 5 in relation to its lower part 5b and bring the two lugs 11 in the locking position of the shaft 5 below the upper closure wall of the cannula 3.

Finally, the instrument is completely removed from port 1 as shown in <figref idrefs="f0008">8</figref> and the wire 25 secured needles 7 is pulled in order to continue to pass through the thickness of the abdominal wall 2 following the same path as the needles 7 until the loop 25a is located substantially at the bottom of the port 1 at the inside of the abdominal wall 2. the surgeon then only has to cut both end portions of the wire 25 and manually perform a node with both strands of the wire for positioning and close the walls vis-a-vis the orifice 1 comprising apanévrose and the deep muscular plane, with the tension of the thread loop below the wall 2.

The <figref idrefs="f0009">Figures 9 to 11</figref> show another embodiment of the needles 7 of the support member may be used instead of that constituted by the flexible blade 8 of the first embodiment.

According to this second embodiment, the support member is constituted by two arms 26 pivotally mounted on a common central axis 27 integral with the body of the cannula in the lower part 4 thereof and extending perpendicularly to the longitudinal median plane of the cannula. The axis 27 may be fixed by its ends force-fitted respectively in two opposite coaxial holes made in the side wall of the end portion 4 of the cannula 3 and the two arms 26 are pivoted on the axis 27 to the a hinge joint 28.

The two arms 26 comprise integral with their opposite ends, the two sockets 14 in which are removably mounted two needles 7. To enable both base plates 14 to be located in two planes spaced from one another and parallel to longitudinal median plane of the cannula 3, the two arms 26 have, as seen from above, an elongated S-shaped configuration with the curved branches are situated on either side of the axis 27 with the two collars located on a diagonal passing through the geometric center of the axis 27.

The piston rod 5, identical to the rod 5 of the first embodiment, controls the simultaneous pivoting of the two arms 26 by means of two traction arms 29 connected firstly to one another in the lower end of the rod 5 by a hinge pin 30 integral with the rod parallel to the pivot axis 27 and secondly at their opposite ends in an articulated manner respectively to the two support arms 26, in the vicinity of the bases 14 support needles 7.

When the instrument is inserted through the abdominal wall 2, the two arms 26 are in their position shown in <figref idrefs="f0009">Figure 10</figref> on which the two arms are raised above the hinge pin 27 in defining an acute angle for accommodating the end portions of arms 26 and their associated needles 7 in the lower end portion 4 of the cannula 3 .

To deploy the two arms 26 to their open position projecting through the windows 10 of the lower part 4 of the cannula 3, the surgeon pushes down the cannula of the piston rod 5 so that the two pulling arms 29 do rotate the two arms 26 about the axis 27 separating them from one another to the position at which the pins 7 are located below the wall 2 as shown in <figref idrefs="f0002">2</figref>.

Otherwise, the operating principle of the instrument provided with the support member according to the second embodiment is identical to that described previously with reference to the first embodiment, except that it is necessary to exert a thrust force on the piston rod 5 to deploy the needles to their projecting position outside of the cannula 3 and pull the rod 5 to collapse again by bringing the one of the other two arms 26 and the housing, without the needles, in the end portion 4 of the cannula 3 before complete removal of the instrument of the orifice 1. the other difference relative to the first embodiment is that the locking of the rod 5 to the particular position housing arm 26 and needle 7 in the end portion 4 before insertion of the cannula into the wall 2 takes place by bringing the two locking lugs 11 of the upper closure wall of the cannula 3 transverse to the light 12 and, to facilitate the deployment of the two arms 26 to their position shown in <figref idrefs="f0009">9</figref>, It is possible to provide a coiled torsion spring on the pivot pin 27 and acting on the two arms 26 a resilient force tending to separate them from each other and maintain their deployed position.

The instrument according to the invention allows to effectively close the trocar passage opening and suturing the muscle and fascia of the abdominal wall of a patient.

By way of indication, the instrument may have a length of about 20 cm with a maximum external diameter of 12 mm at its enlarged portion, the diameter of the cannula to its two-thirds of its length can be 10 mm . In position projecting from the flexible strip 8 or the arm 26 for supporting the needle 7, the ends thereof may extend beyond the lower end portion 4 of the cannula 3 of 5 mm to 7 mm on either side of celle- this. Of course, these dimensions are given by way of non-limiting example.