Fascial traction apparatus for the surgery of large hernia defects

Abstract

A fascial traction device (1) for procedures for the treatment of large hernias, which comprises: - a support vertical upright (2), lockable in fixed way to an operating table (B); - a transverse operating bar (4) bearing a plate (5) for securing surgical sutures for tensioning the fascial tissue; - means (6) for connecting the transverse bar (4) to the longitudinal upright (2), allowing the bar (4) to slide and vary its inclination (α), wherein the overall arrangement is such that, in use, the traction tension applied on the fascial tissue by means of the sutures can be adjusted by translating and / or rotating the transverse bar (4) with respect to the upright (2).

Description

[0001] FASCIAL TRACTION APPARATUS FOR THE SURGERY OF LARGE HERNIA DEFECTS

[0002] DESCRIPTION

[0003] Technical field of the invention

[0004] The present invention relates to the field of the medical-surgical apparatuses and, more specifically, to the traction devices used for the intraoperative closure of a body wall, in particular the abdominal wall in case of surgery of large ventral hernias.

[0005] State of art

[0006] One of the most critical aspects of the surgery of ventral hernias, in particular those having large sizes, is the subsequent reconstruction of the abdominal wall. In fact, once the median line of such wall has been opened, the anterolateral muscles retract quickly and it becomes difficult to bring closer again the boundaries of the fascia that has been severed, that is of the fibrous- connective tissue layer covering the muscles. In other situations, even part of the fascia is removed by making still more difficult to bring closer again the boundaries of the fascia.

[0007] Therefore, the most challenging step in repairing large hernias is indeed the fact of closing the median line of the fascia, that is restoring the abdominal wall in the most anatomical, or at least physiological, possible way.

[0008] In relatively recent times some traction devices have been introduced which apply a tension on the fascial tissue, during the procedure, with the purpose of stimulating a lengthening thereof which allows the subsequent recomposition by suturing.

[0009] Such fascial traction concept was introduced in 2017 (see for example: D. Eucker et al, “Abdominal Wall Expanding System Obviates the Need for Lateral Release in Giant Incisional Hernia and Laparostoma" , Surgical Innovation 1-7, https: / / doi.Org / 10.1177 / 1553350617718, Sage 2017).

[0010] The different types of known devices exert traction in different directions. In particular, both tractions “horizontally”, that is almost parallel to the operating table, and “vertically”, that is almost orthogonal to the operating table, were described.

[0011] It has to be specified that the fascial tissue subjected to traction behaves mechanically by giving a partially elastic and partially plastic response. In particular, at first the tissue opposes the tension, but within few minutes it tends to deform plastically, by lengthening. For this reason, the procedure provides after few minutes different traction phases, allowing to obtain a sequence of tissue deformations, the sum thereof is sufficient to implement the closure.

[0012] The horizontal traction is preferred, since it leads to the approximation of the edges of the fascial tissue, by making the suture implementation simpler. The vertical traction is more effective in obtaining the wished deformation entity, since the fascial tissue does not interact with the underlying tissues on which part of the tension could be discharged, by making it less effective in the fascia deformation.

[0013] However, the known devices are configured so as substantially to clutter to a substantial extent the operating space, by limiting the surgeon’s freedom of action.

[0014] Moreover, at time of the final suture such known devices have to be removed. Consequently, between the disengagement of the fascia and the suture a technical time elapses which in fact can determine a new retraction of the tissue and then an at least partial nullifying of the preceding fractional action.

[0015] Still, the known devices often result to be not very manoeuvrable and versatile in the operating environment, by increasing the surgeon’s level of engagement and then the stress on her / him.

[0016] Summary of the invention

[0017] The technical problem placed and solved by the present invention then is to provide a traction apparatus allowing to obviate the drawbacks mentioned above with reference to the known art.

[0018] Such problem is solved by a device according to claim 1 and by an apparatus according to claim 14.

[0019] Preferred features of the present invention are set forth in the depending claims. The invention provides a mechanical traction apparatus devised to ease a controlled and symmetrical approach, which applies an oblique tension to the tissue edges, in particular in the ventral hernias having large sizes. The apparatus allows to exert a traction at first in direction close to “vertical”, to maximise the produced deformation and to modify such direction, in a second phase, in direction closer to “horizontal” so as to ease closing the abdomen.

[0020] The apparatus allows to control the traction in a standardized process, by reducing to the minimum the risk of lacerations or overextension injuries and allowing an optimum surgical closing of the hernial defect. In particular, the apparatus allows to reduce gradually the defect without generating an excessive tension on the surrounding tissues, until the opposing tissue edges are brought closer, allowing to perform a closing suture without tension of the hernial effect.

[0021] The apparatus of the invention results to be extremely effective and versatile, easy to handle and with minimum overall dimensions of the operating space.

[0022] Advantageously, the overall structure of the apparatus is robust, reliable and sterilizable.

[0023] The apparatus can be configured for different surgical procedures, with the possibility of adapting to different widths of the operating table and hernia sizes.

[0024] According to a preferred embodiment, the fascial traction apparatus comprises, for each incision side, a vertical support, for example in form of bar or upright, firmly fixable on a respective side of the operating table. Each vertical support is connected to an oblique transverse bar, preferably so as to allow both a longitudinal, that is vertical, sliding, of the bar along the support and a change in its inclination.

[0025] At the bar end a suture retaining element is applied, for example in form of perforated plate preferably orthogonal to the bar itself. Such element fixes, for example by knotting, the end of sutures applied to the hernia counterlateral edges.

[0026] Other advantages, features and use modes of the present invention will result evident from the following detailed description of some embodiments, shown by way of example and not for limiting purposes. Brief description of figures

[0027] The figures of the enclosed drawings will be referred to, wherein:

[0028] ■ Figure 1 shows a front view of a preferred embodiment of the fascial traction apparatus according to the present invention;

[0029] ■ Figure 2 shows a top perspective view of the apparatus of Figure 1 ;

[0030] ■ Figure 3 relates to a first configuration of an embodiment variant of the apparatus of Figure 1 during a set-up preliminary phase, showing a front schematic view thereof highlighting some exemplifying sizes;

[0031] ■ Figure 4 relates to a second configuration of the apparatus of Figure 3 during an intermediate phase of intensive traction, showing a front schematic view thereof highlighting some exemplifying sizes;

[0032] ■ Figure 5 relates to a third configuration of the apparatus of Figure 3 during a terminal phase of consolidation traction, showing a front schematic view thereof highlighting some exemplifying sizes;

[0033] ■ Figure 6 shows a perspective view of a preferred embodiment of some components of the traction apparatus of Figure 1 .

[0034] Detailed description of preferred embodiments

[0035] Various embodiments and variants of the invention will be described hereinafter, and this with reference to the above-mentioned figures.

[0036] Analogous components are designated in the different figures with the same numeral reference.

[0037] In the following detailed description, additional embodiments and variants with respect to embodiments and variants already treated in the same description will be illustrated limitedly to the differences with what already illustrated.

[0038] Moreover, the different embodiments and variants described hereinafter are likely to be used in combination.

[0039] By firstly referring to Figures 1 and 2, a traction apparatus according to a preferred embodiment of the invention is designated as a whole with 100. The apparatus is configured to be used in surgical procedures, in particular for treating large hernias. The apparatus then is shown in association with an operating table B, or with analogous structure, on which a patient body is supposed to be laid. The operating environment, or space, in which the surgeon operates is designated with 0.

[0040] The apparatus 100 comprises a pair of fascial traction devices, 1 and T, respectively, configured to be arranged on opposite sides of the table B and facing the operating space 0.

[0041] The two devices 1 and T, in the present example, are identical and arranged specularly. Therefore, only the device 1 will be generally described hereinafter 1.

[0042] The device 1 first of all comprises a support longitudinal upright 2, configured to be arranged, in use, substantially vertically. Such vertical direction, then, in this arrangement corresponds to the prevailing development longitudinal direction L of the upright 2. The latter can have, for example, generally cylindrical transverse section.

[0043] The upright 2 is lockable on the operating table B or on a similar structure. In the present example, movable locking means 3 is provided, for example in form of jaws. Such locking means is known on itself in the art and common also to devices of different type, therefore one will not further dwell upon their description.

[0044] The upright 2, moreover, has a telescopic construction, exemplified with the numeral reference 20, so as to have adjustable length (that is overall longitudinal extension).

[0045] The device 1 then comprises a transverse operating bar 4, assembled on the upright 2 by connecting means designated as a whole with 6. The latter is configured so as to allow the bar 4 to slide on the upright 2 so as to be able to translate along the longitudinal extension thereof, according to a movement direction exemplified with the arrow L in Figure 1. Preferably, the means 6 is configured to allow the longitudinal position of the transverse bar 4 on the longitudinal upright 2 to be shifted by about 10-50 cm.

[0046] With also reference to Figure 6, the height of the bar 4 with respect to the operating space 0 can be locked by a handle 62, or a component with analogous function, of the connecting means 6.

[0047] The means 6 is also configured to allow a variation, in particular an adjustment, in the inclination a of the bar 4 with respect to the upright 2, according to a rotation motion exemplified with an arrow R in Figure 1. Also in this case, the motion for varying the inclination can be controlled and managed by the same handle 62 or a different component. Preferably, such inclination a can vary in an interval of about 20-60 degrees circa.

[0048] Preferably, the connecting means 6 also comprise a mechanism configured to vary the relative position of the transverse bar 4 with respect to the longitudinal upright 2, by retracting or advancing the bar 4 with respect to the operating space 0, according to a motion in a direction exemplified with T in Figure 1 .

[0049] Such mechanism can include a gear wheel-rack coupling, wherein the rack profile is obtained directly on a segment of the bar 4 and wherein a complementary gear is provided on, or actuated by, a lever, or crank, 61. In embodiment variants, the same mechanism can even allow said variation in the inclination a.

[0050] At or near its own distal end with respect to the upright 2 facing the operating space 0, the bar 4 has a plate 5 for securing surgical suture threads, or sutures. The latter are represented, schematically, in the subsequent Figures 3 to 5 and herein designated with c. Such sutures are intended to hook, at its own distal end with respect to the plate 5, a fascial tissue to traction. In particular, the plate 5 has a plurality of seats 51 , for example in form of slots or holes, each one configured to lock the end of one or more sutures, for example by knotting the latter on the structure of the plate 5. Advantageously, such seats 51 are arranged aligned according to a prevailing extension direction M of the plate 5. Such direction is preferably orthogonal to the extension direction E of the bar 4, that is to the traction direction.

[0051] The inclination of the plate 5 with respect to the bar 4 can be adjustable by means 50 of type known in itself, for example a ball joint provided with securing mechanism.

[0052] Moreover, in some embodiments even the length of of the bar 4, according to the extension direction exemplified with an arrow E in Figure 1 , can result to be adjustable, for example by means of a telescopic construction.

[0053] Advantageously, the upright 2 and / or the bar 4 can be made of metal, for example of steel. Moreover, one or both of them can have position markers along its own extension, for example every 5 cm or every 10 cm.

[0054] The operation of the device 1 , T, and then of the apparatus 100, will be now described with reference to Figures 3 to 5, showing schematically an embodiment variant of the devices 1 , T similar to the one described sofar. Each device can incorporate, in the shown variant, a dynamometer 8, or other means for measuring or transducing the applied traction force. Such force, in the prevailing extension direction E of the bar 4, is exemplified with an arrow F in Figures 4 and 5.

[0055] The overall arrangement is such that, in use, on one edge of fascial tissue S, S’ one applies a tension adjustable by a vertical translation, a rotation and / or a modification of the transverse position of the bar 4 with respect to the longitudinal upright 2. Such traction is exerted by sutures c, c’ interposed between the plate 5, 5’ and the respective edge of tissue S, S’.

[0056] Figure 3 relates to an initial phase for setting-up the apparatus 100. In the considered example, the bar 4, 4’ of the device 1 , T, hooks a respective edge of fascial tissue S, S’, according to a crossed arrangement in which each bar 4, 4’ is connected to the edge S, S’ opposite thereto. The arrangement defines, in the shown view and for each device 1 , T, a right triangle, wherein:

[0057] - the hypotenuse, having length h, is defined between the point of the bar 4, 4’ connecting to the respective upright 2, 2’ and the point wherein the respective suture c, c’ engages the respective edge of tissue S, S’; such hypotenuse then corresponds to the traction direction along the bar 4, 4’;

[0058] - a first horizontal cathetus, having length I2, is defined as the transverse distance between the point for hooking the edge of tissue S, S’ and the upright 2, 2’;

[0059] - a second vertical cathetus, having length I3, is defined as the longitudinal distance between the point of the bar 4, 4’ for connecting to the respective upright 2, 2’ and the intersection of the second cathetus with the upright itself.

[0060] In this configuration, preferably the inclination a assumes a first value comprised in an interval of about 30-40 degrees, advantageously about 35-36 degrees. Preferably, the above-mentioned lengths can vary in the following respective intervals: / ?=about 40-50 cm, preferably about 46 cm; / 2=about 25-35 cm, preferably about 29 cm; / 3=about 35-45 cm, preferably about 40 cm.

[0061] Preferably, the value of traction force F is substantially equal to zero in this arrangement.

[0062] Figure 4 shows a subsequent, second configuration, consequent to the application of a progressive traction, in particular for an elongation of about 1 cm per edge S, S’ every two minutes, to cover an elongation defect of 14 cm in eight tractions and 16 minutes. Such elongation is obtained by modifying the inclination a of each bar 4, 4’.

[0063] In this configuration, preferably the inclination a assumes a second value comprised in an interval of about 20-30 degrees, advantageously about 26-27 degrees. Preferably, the above-mentioned lengths can vary in the following respective intervals: / ?=about 35-45 cm, preferably about 39 cm; / 2=about 20-25 cm, preferably about 22 cm; / 3=about 35-45 cm, preferably about 40 cm.

[0064] Preferably, the value of traction force F is comprised in an interval of about 15- 25 N at the end of the traction, preferably about 19-20 N.

[0065] In this configuration a traction with a prevailing component in vertical direction and, generally, parallel to the longitudinal extension of the uprights 2 is exerted.

[0066] Figure 5 shows a subsequent, third configuration, wherein the traction direction is brought as close as possible to the horizontal. In this configuration, preferably the inclination a assumes a third value comprised in an interval of about 50-60 degrees, advantageously about 56-57 degrees. Preferably, the above- mentioned lengths can vary in the following respective intervals: h= about 35-45 cm, preferably about 39 cm; = about 20-25 cm, preferably about 22 cm; / 3=about 10-20 cm, preferably about 15 cm.

[0067] Preferably, the value of traction force F is comprised in an interval of about IQ- 20 N at the end of the traction, preferably about 15-16 N.

[0068] Therefore, preferably in this third configuration the length h remains unchanged with respect to the second configuration.

[0069] * * *

[0070] By pure way of example, a type of treatment, which can be performed with the above-described apparatus, is illustrated hereinafter.

[0071] The treatment consists of three phases: (a) the patient pre-enabling before the procedure, (b) the hernia manipulation surgery and (c) the application of the traction apparatus.

[0072] (a) Pre-enabling

[0073] The pre-enabling is performed by applying botulinum toxin A as coadjuvant through the toxin infiltration in the abdominal wall. It was suggested for the preoperating use in patients with hernias having sizes larger than 10 cm and it is administered by injections in the abdominal wall.

[0074] The number of used units of botulinum toxin A and the specific dosage can vary, but generally three to five injections per side of the abdominal wall and per muscle (external oblique, internal oblique and transverse abdominal) plane are administered. The application is ideal four to six weeks before the surgical procedure.

[0075] The surgical technique is the retromuscular repair or so-called open Rives- Stoppa technique. The following phases are provided.

[0076] ■ Skin incision and dissection of the hernia sac: a skin incision is made in the involved abdominal region, the hernia sac is sectioned by the subcutaneous cellular tissue and by the aponeurotic edges of the defect, by opening it or not depending on the cases.

[0077] ■ Retromuscular access: by accessing through the incision, one reaches the space between the rectus abdominis muscles and posterior aponeurosis. The defect is closed on the rear plane with the posterior aponeurosis or with the sac itself, if necessary.

[0078] ■ Positioning of the mesh: an intermediate molecular weight macroporous polypropylene mesh is positioned in the retromuscular space. The mesh is adjusted so as to cover completely the space selected between the muscular bellies and the posterior aponeurosis and to reinforce the abdominal wall.

[0079] (c) Traction and closure of the defect

[0080] Six parallel sutures are applied, along the lateral edges of the defect (three per edge), which will be knotted to the counterlateral plate of the fascial traction device. The system applies the traction until closing the defect, at this point the defect edges are sutured together with a continuous suture.

[0081] The sutures are arranged through the herniated tissue, so that three sutures are positioned at each end of the hernia defect. These sutures are knotted to the plates, which are connected to the traction mechanism of the bar.

[0082] The procedure can even be performed laparoscopically or endoscopically (eTEP). In this case minimally invasive incisions are performed and one accesses to the retromuscular space endoscopically. The sutures to apply the fascial traction are applied percutaneously.

[0083] The present invention has been sofar described with reference to preferred embodiments. It is to be meant that other embodiments belonging to the same inventive core may exist, as defined by the protective scope of the herebelow reported claims.

Claims

CLAIMS1. A fascial traction device (1 , T) for use in surgical procedures, in particular for the treatment of a hernia, which device (1 ) comprises:- a longitudinal support upright (2), lockable on an operating table (B) or on a similar structure and configured to be arranged, in use, substantially vertical;- a transverse operating bar (4), bearing means (5, 51 ) for securing surgical sutures for tensioning a fascial tissue (S);- means (6) for connecting said transverse bar (4) to said longitudinal upright (2), suitable for enabling said bar (4) to slide along the longitudinal extension (L) of said upright (2) and also to vary its inclination (a) with respect to said upright (2), wherein the overall arrangement is such that, in use, to the fascial tissue a tension of direction is applied, selectable by a translation and / or a rotation of said transverse bar (4) with respect to said longitudinal upright (2).

2. The device (1 ) according to claim 1 , wherein said longitudinal upright (2) comprises means (3) for the detachable locking on an operating table (B) or on a similar structure, for example in the form of jaws.

3. The device (1 ) according to claim 1 or 2, wherein said longitudinal upright (2) has a telescopic construction, so as to have adjustable length.

4. The device (1 ) according to any one of the preceding claims, wherein said means for securing surgical sutures comprises a plate (5) mounted at one end of said transverse bar (4).

5. The device (1 ) according to the preceding claim, wherein said plate (5) has a plurality of suture insertion seats (51 ).

6. The device (1 ) according to claim 4 or 5, wherein said plate (5) has an adjustable inclination (50) with respect to said transverse bar (4).

7. The device (1 ) according to any one of the preceding claims, wherein said connecting means (6) comprises a mechanism configured to vary the relative position of the transverse bar (4) with respect to the longitudinal upright (2), by retracting or advancing (T) said transverse bar (4) with respect to an operating space (0).

8. The device (1 ) according to the preceding claim, wherein said mechanism comprises a gear wheel-rack coupling.

9. The device (1 ) according to any one of the preceding claims, wherein said connecting means (6) is configured to vary the inclination (a) of said bar (4) withrespect to said upright (2) so as to obtain a first configuration suitable for the application of a tension with a prevailing component in a direction substantially parallel to the longitudinal extension of said upright (2), in particular substantially vertical, and a second configuration suitable for the application of a tension with a prevailing component in a direction substantially orthogonal to the longitudinal extension of said upright (2), in particular a substantially horizontal direction.

10. The device (1 ) according to any one of the preceding claims, wherein said connecting means (6) is configured to vary the inclination (a) of said bar (4) with respect to said upright (2) in an interval of about 20-60 degrees, preferably by allowing said bar (4) to assume a first inclination included in an interval of about 30-40 degrees, a second inclination included in an interval of about 20-30 degrees and / or a third inclination included in an interval of about 50-60 degrees.

11. The device (1 ) according to any one of the preceding claims, wherein said connecting means (6) is configured to move the longitudinal position of said bar (4) on said upright (2) to be shifted by about 10-50 cm.

12. The device (1 ) according to any one of the preceding claims, which is configured to apply a tension according to the direction of said transverse bar (4) included in an interval of about 10-25 N, preferably about 15-20 N.

13. The device (1 ) according to any one of the preceding claims, comprising means (8) for measuring the tension applied by means of said transverse bar (4), in particular a dynamometer.

14. An apparatus (100) comprising a pair of traction devices (1 , T), each one according to any one of the preceding claims and configured to be arranged with respective transverse bars from opposing and facing sides in a same operating space (O).

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