WO2015118433A1

WO2015118433A1 - A pneumatic prosthetic positioner for videolaparoscopic laparoplasty

Info

Publication number: WO2015118433A1
Application number: PCT/IB2015/050714
Authority: WO
Inventors: Antonio DARECCHIO
Original assignee: Darecchio Antonio
Priority date: 2014-02-10
Filing date: 2015-01-30
Publication date: 2015-08-13

Abstract

A surgical prosthetic positioner for videolaparoscopic laparoplasty is characterised in that it comprises an inflatable chamber (2) made of a material suitable for surgical use for positioning and supporting a prosthesis (mesh (8)) outside thereof, the chamber (2) being such as to have, when in operation and inflated, a surface extension that occupies all a peritoneal or abdominal cavity in which it is inserted, becoming adapted to a shape of the cavity and taking on a shape of the cavity with an intimate and complete surface contact in each recess, the active external surface of the chamber (2) being greater than the surface extension of the prosthesis (8). The chamber (2) is made of a material that is such as to enable, from inside the chamber (2), a view in transparency of the surrounding abdominal structure and the prosthesis to be positioned and supported.

Description

DESCRIPTION

A Pneumatic Prosthetic Positioner for Videolaparoscopic

Laparoplasty

Technical field

The present invention relates to a surgical instrument and in particular a pneumatic prosthetic positioner for videolaparoscopic laparoplasty.

Background art

With particular reference to repair of hernias of abdominal walls and abdominal wall defects at a surgical wound site, surgical practice includes, in general terms, positioning of a prosthesis of dedicated material and variable dimensions with the aim of reinforcing the abdominal wall and reestablishing the integrity thereof.

During the surgical operation surgical trocars can be used, i.e. tubular instruments through which dedicated instruments are inserted inside body cavities, including CO₂ for inflating.

In recent years a further technique has been frequently used which includes positioning suitable prostheses introduced into the peritoneal cavity via laparoscopy, thus avoiding more invasive dissections.

The hernia content is reduced in the surgical operation, up to obtaining a hernia opening that is clear and any further viscero-parietal and viscerovisceral adherences are lysed. A dedicated prosthesis is introduced into the abdominal cavity (various types exist made of different materials and having different characteristics).

The prosthesis (mesh) is fixed using mechanical means (the only presently-available means) such as Protack ® titanium spirals or Absorbatack ® self-tapping and absorbable screws, anchors or the like. However, said mechanical means are often a cause of early complications (bleeding or iatrogenic lesions) and late complications (chronic pain and adherence syndromes).

US 5,865,728 discloses an inflatable device for creating a surgical operating space inside the human body. This device comprises a main non-elastic envelope constituted by a polyhedral structure realized by a joining of flat or curved pieces of plastic film. The main envelope comprises an inflatable chamber and a second envelope is applied thereon so as to form additional chambers which give rise to a cage structure.

The above-described document is however aimed at creating work-space inside the inflatable chamber, but has a shape and cage-structure of its own which cannot make the prosthesis (mesh) adhere intimately and completely to the parietal peritoneum and therefore is not suitable for the aims of the present invention as specified in the following.

In substance it is a sort of basket with a netted frame having windows which cannot imitate the internal abdominal walls and has simply the functions of a primordial divaricator.

US 2012/0016369 A1 relates to a method and apparatus for treating vertebral fractures, i.e. it relates to a sector of surgery that is very distant in terms of type of problem with respect to the sector of abdominal videolaparoscopic surgery.

In fact, in the treatment of vertebral fractures the spaces are much smaller, there are no soft tissues, the pressures are very high and there is no prosthesis or mesh to be applied. This is the classic kyphoplasty technique in which a chamber is inflated at high pressure in the spongey tissue of the vertebra in order to create space in the vertebral body and not to position a prosthesis/mesh.

US 2003/0236544 A1 discloses a method and an inflatable chamber for separating layers of tissue with the aim of creating a cavity in which to operate, which requires use of high pressures and is not suitable for positioning and sustaining prostheses outside the inflatable chamber, and is typically used for treatment of inguinal hernias.

WO201 1 /128622 A1 discloses a surgical device and method for creating a working space inside the human or animal body. Surgical operations occur inside the inflatable chamber and with drawbacks alike those of US 5,865,728.

None of the above-cited documents shows instruments suitable for internally complementing the shape of the abdominal wall and exerting a substantially uniform pressure over all the extension thereof.

They are in fact instruments which once inflated and in place assume a shape of their own (and not that of the surrounding environment).

Disclosure of the invention

The aim of the present invention is to obviate the above-cited drawbacks, providing a surgical instrument and a method for performing laparoscopic operations for treatment of hernias and abdominal wall defects which prevent chronic post-operative pains and the other complications as mentioned above.

A further aim is to enable this to be achieved in an extremely simple and economical way.

These aims are fully attained by the pneumatic prosthetic positioner for videolaparoscopic laparoplasty of the present invention, which is characterised by what is contained in the claims reported below and in particular in that the positioner comprises an inflatable chamber made of extensible or non-extensible material, so as to have, during operation and once inflated, a surface extension which occupies all the abdominal cavity and adapts to the shape of said cavity and takes on the shape of said cavity with an intimate and complete surface contact in each recess, substantially forming a mould of the internal abdominal wall and the surface of the viscera, the active external surface of the inflatable chamber being greater than the surface extension of the prosthesis (mesh), which said inflatable chamber positions and sustains uniformly, outside thereof, during the step of application by gluing. The chamber is made of a material which is such as to enable, from inside thereof, a vision in transparency of the surrounding abdominal structure and of the prosthesis to be positioned and supported.

The chamber is made of a non-extensible material, or of an extensible material: in a case in which it is made of a non-extensible material, it has a greater volume in an inflated configuration than a volume of the abdominal cavity in which it is destined to operate.

The inflatable chamber is preferably realised by superposing two medical polyethylene sheets welded to one another along the perimeter.

In an embodiment the positioner comprises a plurality of angular elements externally heat-welded to the inflatable chamber to which the prosthesis or mesh is anchored by surgical sutures.

The chamber, once introduced into the abdominal chamber of a patient, is inflated with the aim of maintaining the prosthesis correctly positioned and supported during the gluing of the prosthesis to the abdominal wall.

The positioner preferably comprises a tap or valve for regulating inflow of a gaseous fluid into the inflatable chamber, and also preferably comprises a gasket or a check valve so as to prevent the air or gas from exiting through an opening in which optical viewing means are insertable.

The use of the surgical prosthetic positioner for videolaparoscopic laparoplasty, following a reduction of the hernia content and adhesiolysis, includes steps of:

- introducing a prosthesis for videolaparoscopic laparoplasty (mesh) and suspending and centring on drawing wires transfixed through the abdominal wall to centre a wall defect.

- introducing the prosthetic positioner comprising an inflatable chamber, possibly associated to a trocar or to a tube introducer cut longitudinally.

- feeding gas and inflating the chamber so that the mesh can uniformly support the mesh and enable intimate adherence to the abdominal wall, adapting to any irregularities thereon.

- gluing the prosthesis to the abdominal wall.

- deflating the chamber and extracting the chamber. The use of the surgical prosthetic positioner for videolaparoscopic laparoplasty, following a reduction of the hernia content and adhesiolysis, can include steps of:

- introducing a plurality of needle cannulas perimetral to a defect in the abdominal wall and with a sufficient overlap, transfixed to the abdominal wall, then removing the metal core of said needle cannulas; the needle cannulas are introduced at the points where a prosthesis, i.e. a mesh, is to be applied/fixed.

- introducing prostheses for videolaparoscopic laparoplasty (mesh) and suspending and centring on drawing wires transfixed through the abdominal wall to centre the defect in the wall.

- introducing a prosthetic positioner comprising an inflatable chamber, adequately folded, opening out the inflatable chamber and correctly arranging thereof in the abdominal cavity, possibly using reference markers present on the chamber;

- removing a pointed metal core of the needle cannulas.

- feeding gaseous fluid and inflating the inflatable chamber such that all the elements go into abutment and the mesh intimately adheres to the abdominal wall, adapting to any irregularities thereof.

- possibly supplying surgical adhesive through the needle cannulas, drop by drop, by means of small pre-filled and pre-dosed syringes, at the fixing point of the prostheses.

- gluing the prosthesis to the abdominal wall.

- removing the needle cannulas.

- deflating the chamber and extracting thereof.

In a case of use of the tube introducer, the mouth of the inflatable chamber is enveloped about a rigid collar also inserted in the tube introducer. The function of the tube introducer is to contain the chamber, folded on itself, at the moment of insertion in the body; then it is made to slide out manually, leaving the chamber inserted (deflated) and a sleeve is applied on the collar projecting out of the patient's body (human or animal). Brief description of drawings

These and other characteristics will more fully emerge from the following description of a preferred embodiment, illustrated by way of non-limiting example only in the accompanying tables of drawings, in which:

- figure 1 illustrates the inflatable chamber in plan view and laid out with the positioner;

- figures 2, 3, and 4 illustrate the chamber during operation, respectively rolled, laid out, uninflated and inflated, during various steps of the surgical operation;

- figure 5 and 6 respectively illustrate the positioning of a prosthesis in a case of median and subcostal abdominal wall defects;

- figure 7 shows a tube introducer for housing the inflatable chamber, in a perspective view;

- figure 8 schematically illustrates the inflatable chamber rolled up and folded, which is destined to be contained in the tube of figure 7;

- figure 9 shows a vertical section of the tube with the folded-up inflatable chamber positioned inside thereof;

- figures 10 and 1 1 illustrate, respectively in a perspective view and in a vertical section, a sleeve destined to envelop the mouth of the inflatable chamber.

Detailed description of preferred embodiments of the invention

With reference to the figures, 1 denotes in its entirety a prosthetic positioner comprising an inflatable chamber 2 which, in a deflated configuration, is appropriately folded and rolled (figure 9) and preferably housed in a tube introducer 3.

The inflatable chamber 2, in the form of a membrane or slim and transparent film, is preferably made of polyethylene, by superposing and welding of two sheets of medical polyethylene.

In this case, which is illustrated, the chamber is non-extensible, but in a variant embodiment, not illustrated, it can be made of an extensible material such as for example polyurethane. In the illustrated embodiment, the chamber 2 is provided with a cord or appendage 4 which is welded (preferably by heat-welding) to a rigid collar 5, preferably made of a plastic material, or the chamber 2 can be anchored directly to the distal end of the collar 5 without any need of a true and proper appendage 4.

The chamber can have, in opened-out configuration, the appearance of figure 1 with a tapered portion 2a (destined for the funnel pelvis) and a further portion 2b, or can be elliptical or symmetrical with respect to the entry appendage.

In particular, in the preferred embodiment illustrated in figures from 7 to 1 1 , the chamber 2 can be initially contained in a novel way in the tube 3 made of a plastic material cut longitudinally and with walls thereof that can partly elastically overlap. The mouth of the chamber 2 is wound about the rigid collar 5.

The chamber 2 in the deflated configuration is folded, rolling the two portions or half-parts 2a, 2b on themselves, one in a clockwise direction and the other in an anticlockwise direction, up to flanking them longitudinally to one another at the longitudinal cut of the tube introducer. In a preferred operating mode, after the tube introducer with the inflatable chamber has been inserted in the abdomen, the tube introducer is entirely removed outside the inflatable chamber and of the collar 5, which are instead maintained in position (it is sufficient to use a finger to retain the collar 5 pushed towards the abdomen while the other hand grips the collar 3 and deinserts it outside); then a sleeve 6 is applied to the collar 5 complete with a valve 13 through which a suitable gas or gaseous mixture is blown so as to distend and inflate the chamber 2 inside the abdominal cavity. The collar 5 removably inserts in the sleeve 6. Figure 9 shows the special rolled enveloping of the two half-parts of the chamber 2 inside the tube introducer 3.

It is however possible to maintain the tube introducer inserted in the abdomen, and in this case the gas introduced into the chamber 2 causes automatic exit from the longitudinal cut/slit of the introducer which elastically opens out during the exit of the chamber.

The chamber 2, in the inflated working configuration, originally has a surface extension which occupies all the peritoneal or abdominal cavity and has an active surface (i.e. the surface acting on a prosthesis to be applied) which is greater with respect to the surface extension of the prosthesis (mesh 8) to be positioned and applied.

Where the chamber 2 is made of a non-extensible material, in the inflated configuration it has a surface or a volume that are greater than those of the abdominal cavity in which it is destined to operate. In this way it creates a "neo pneumoperitoneum", and harnesses the pneumoperitoneum.

The chamber 2 is further made of a light-transparent material, or in any case such as to enable vision in transparency, from inside thereof, of the surrounding abdominal structure and the prosthesis to be applied. The chamber 2 can be not completely transparent due to the presence for example of some identifying scripts.

The novel surgical method using the positioner 1 with the chamber 2 includes following steps.

- reducing the hernia content and adhesiolysis according to techniques already in use.

- introducing a plurality of needle cannulas 10 perimetral to a defect in the abdominal wall and with a sufficient overlap, transfixed to the abdominal wall, then removing the metal core of said needle cannula; the needle cannulas 10 are introduced at the points where a prosthesis, i.e. a mesh 8 is to be applied/fixed.

- introducing prostheses for videolaparoscopic laparoplasty (mesh 8) for example by means of trocars and suspending and centring on drawing wires 9 transfixed through the abdominal wall to centre the defect in the wall; the mesh remains suspended unanchored in the abdomen as illustrated in figure 3. - removing a pointed metal core of the needle cannulas.

- introducing the pneumatic positioner comprising the folded chamber 2, opening out and inflating of the chamber and correct arrangement thereof in the inflated configuration in the abdominal cavity using any eventual reference markers present on the chamber, under video control. In the variant with the extensible chamber the opening-out step is not necessary.

- inflation of the chamber 2 is achieved by feeding gas (for example CO₂) or a gaseous mixture, for example through the sleeve 6 such that all the elements move into an abutment position and the mesh intimately adheres to the abdominal wall, adapting to any eventual irregularities of the wall shape.

supplying surgical adhesive through the needle cannulas, drop by drop, by means of pre-filled and pre-dosed small syringes.

In substance, the 30-40 titanium coils are originally replaced by a plurality of needle cannulas through which a surgical adhesive is brought to the fixing points of the mesh, which is thus originally glued (preferably with cyanoacrylate-based adhesive) to the parietal peritoneum. Over time the mesh is integrated by biological phenomena.

The chamber 2 serves especially for the tens of seconds or so required for the action of the glue to take hold, and, thanks to the fact that it moulds the shape of the surrounding environment, exerts a uniform pressure over all the surface of the mesh, facilitating a perfect adhesion and subsequent gluing to the wall. The chamber therefore does not have a predetermined shape of its own, but time-by-time takes on the shape of the cavity in which it is inserted, by adhering to the cavity walls.

- Removal of the needle cannulas.

- Deflation of the chamber 2 and extraction thereof.

As soon as self-adhesive meshes are available for videolaparoscopic laparoplasty, neither glue nor needle cannulas will be required, as only the action of the pneumatic positioner, i.e. the chamber 2, will be required. Viewing means 12 with fibre optics (only schematically illustrated) are inserted through the sleeve 6 and the collar 5 (the collar 5 penetrates partially inside the patient's body).

Two lateral trocars or use tools are denoted in figures 5 and 6 by reference numeral 1 1 , which trocars act laterally with respect to the central zone where the tube positioner 1 is introduced.

The inventor is aware of the existence in the medical sector of devices comprising balloons, such as for example Spacemaker ® or mechanical Accumesh ® by Covidien. They are however used for different pathologies and for different aims from those of the present invention. They are in fact balloons inserted in the properitoneal space of the lower quadrants of the abdominal wall for creating a dissection, i.e. for separating the properitoneal space from the retromuscular space in the operation known as TEP (totally-extra peritoneal laparascopic technique for inguinal hernia repair).

On the contrary, in the present invention, the inflatable chamber 2 is absolutely not used for creating space or for forming a cavity, but is originally introduced in a cavity (already existing) with the aim of maintaining a prosthesis (mesh 8) correctly positioned and supported during the step of gluing/fixing thereof to the abdominal walls.

The chamber 2 is further inflated preferably with CO₂ at low pressures (using the traditional laparoscopic inflation system), while in the case of devices for inguinal hernia it is normally inflated with air at high pressure with a manual pump.

In a variant embodiment, not illustrated, the prosthesis might be prefixed to the chamber 2. In this case, angular retaining elements might be prefixed to the chamber 2, to which angular elements the mesh is fixed, preferably with surgical sutures. In this case the inflation of the chamber 2 causes automatic opening-out of the mesh.

It is however stressed that the main function of the chamber 2 is to create a perfect and uniform adhesion of the mesh to the abdominal wall during the step of fixing the mesh.

According to what is illustrated, the sleeve 6 comprises the tap or valve 13 for regulating inflow of gas into the chamber 2, as well as a gasket or a check valve 14 for preventing the air or gas from exiting through an opening in which the viewing means 12 can be inserted.

The tap 13 and the gasket or valve 14 can be made of a plastic material and can be applied directly to the end of the chamber 2 (by means of the sleeve 6), and constitute together therewith the surgical positioner, without any need to use any trocars for inserting the chamber 2 into the abdominal cavity.

In substance the chamber 2 can be anchored directly to the tap or valve 13, or to a simplified connecting element, for example the collar 5, then can be inserted in the sleeve 6 provided with the tap 13 and check valve 14 on an opening 7 through which the viewing means 12 can be inserted. The novel neo-pneumoperitoneum concept includes the positioning and non-traumatic fixing of the prosthetic mesh in laparoscopic repair of abdominal wall defects.

The pneumoperitoneum is harnessed and transformed into a surgical instrument.

The present invention, which can be applied to human patients and also to animals, enables a novel laparoscopic surgery of the abdominal walls in which:

- the positioning of the prosthetic mesh is done with a contact of all the surface with the parietal peritoneum due to a uniform pressure exerted by the inflatable chamber 2;

- there is a non-traumatic fixing of the mesh with different types of possible surgical adhesives;

- the intestine is maintained in conditions of absolute safety during the whole procedure.

All of the above is made possible by the use of the positioner of the present invention which supports the prosthetic mesh outside thereof, adapting to the shape of the surrounding abdominal cavity and taking on the shape of said cavity with an intimate surface contact complete in every recess, substantially forming a mould for the internal abdominal wall and the surface of the viscera.

Differently from what is shown with regard to the prior art:

- the present positioner is not used for creating space in which to operate, but for positioning and supporting a prosthesis outside;

- the chamber, once in position and inflated, does not have a shape of its own but adapts and assumes the shape of the surrounding environment; - the chamber 2 is inflated at low pressure, comprised between about 10 and 20 immHg (corresponding to about 13 - 27 millibar) and preferably about 14 - 16 immHg (i.e. about 19 - 21 millibar).

Claims

1 . A surgical prosthetic positioner for videolaparoscopic laparoplasty, characterised in that it comprises an inflatable chamber (2) made of a material suitable for surgical use for positioning and supporting a prosthesis (mesh (8)) outside thereof, the chamber (2) being such as to have, when in operation and inflated, a surface extension that occupies all of a peritoneal or abdominal cavity in which it is inserted, becoming adapted to a shape of said cavity and taking on a shape of said cavity with an intimate and complete surface contact in each recess, substantially forming a mould of the internal abdominal wall and the surface of the viscera,

the active external surface of the chamber (2) being greater than the surface extension of the prosthesis (8),

and in that the chamber (2) is made of a material that is such as to enable, from inside the chamber (2), a view in transparency of the surrounding abdominal structure and the prosthesis to be positioned and supported.

2. The positioner according to claim 1 , wherein the chamber (2) is made of a non-extensible material.

3. The positioner according to claim 1 , wherein the chamber (2) is made of an extensible material.

4. The positioner according to claim 1 , wherein the chamber (2) is realised by a superposing of two sheets of medical polyethylene welded to one another along the perimeter.

5. The positioner according to claim 1 , wherein the chamber (2) has a tapered portion (2a).

6. The positioner according to claim 1 , comprising a plurality of angular elements heat-welded outside the chamber (2) to which the prosthesis or mesh (8) is anchored by means of surgical sutures.

7. The positioner according to claim 1 , wherein a tube introducer (3) cut longitudinally, with edges possibly overlapping, houses the chamber (2) with the tube (3) being free to coaxially deinsert with respect to the chamber (2) so as to enable opening out and inflating the chamber (2).

8. The positioner according to claim 1 , wherein a tube introducer (3) cut longitudinally with edges possible superposed houses the chamber (2), enabling a progressive and automatic exit of the chamber from the longitudinal cut during an inflating stage of the chamber (2).

9. The positioner according to claim 1 , wherein a mouth of the chamber (2) is wound about a rigid collar (5).

10. The positioner according to claim 2, wherein the chamber (2) is made of a non-extensible material, and in the inflated configuration thereof has a surface or a volume that are greater than the abdominal cavity in which it is destined to work, so as to adapt to the shape of said cavity, taking on the shape with an intimate and complete surface contact in each recess which substantially forms a mould of the internal abdominal wall and of the surface of the viscera.

1 1 . The positioner according to claim 9, wherein the collar (5) is removably inserted in a sleeve (6) provided with a tap or valve (13) for regulating the inflow of the gas into the chamber (2).

12. The positioner according to claim 1 , comprising a tap or valve (13) for regulating the inflow of air or gas into the chamber (2), and a gasket or a check valve (14) so as to prevent a gaseous fluid from exiting through the opening (7) in which optical viewing means (12) are insertable.

13. The positioner according to claim 1 , further comprising a tube introducer (3) of a prosthetic mesh (8), said tube introducer (3) being made of a plastic material and defining a longitudinal cut over a whole length thereof.

14. A use method of a surgical prosthetic positioner for videolaparoscopic laparoplasty, characterised in that following a reduction of hernia content and adhesiolysis, includes steps of:

- introducing a prosthesis for videolaparoscopic laparoplasty (mesh 8) and suspending and centring on drawing wires (9) transfixed through the abdominal wall to centre a wall defect. - introducing the prosthetic positioner (1 ) comprising an inflatable chamber (2);

- feeding gas and inflating of the chamber (2) so that the mesh intimately adheres to the abdominal wall, adapting to any irregularities thereon;

- gluing the prosthesis to the abdominal wall;

- deflating the chamber (2) and extraction thereof.

15. A use method of a surgical prosthetic positioner for videolaparoscopic laparoplasty, characterised in that following a reduction of the hernia content and adhesiolysis, it includes steps of:

- introducing a plurality of needle cannulas (10) perimetral to a defect in the abdominal wall and with a sufficient overlap, transfixed to the abdominal wall, then removing the metal core of said needle cannulas; the needle cannulas (10) are introduced at the points where a prosthesis, i.e. a mesh (8), is to be applied/fixed;

- introducing prostheses for videolaparoscopic laparoplasty (mesh 8) and suspending and centring on drawing wires (9) transfixed through the abdominal wall to centre the defect in the wall;

- introducing a prosthetic positioner (1 ) comprising an inflatable chamber (2), and a correct arranging thereof in the abdominal cavity, using reference markers that may be present on the chamber;

- removing a pointed metal core of the needle cannulas (10);

- feeding gas and inflating the chamber (2) such that all the elements go into abutment and the mesh intimately adheres to the abdominal wall, adapting to any irregularities thereof;

- possibly supplying surgical adhesive through the needle cannulas, drop by drop, by means of pre-filled and pre-dosed small syringes, at the fixing point of the prostheses;

- gluing the prosthesis to the abdominal wall;

- removing the needle cannulas (10); - deflating the chamber (2) and extracting it.

16. The method according to claim 15, wherein the chamber (2), introduced into the abdominal cavity of a person or an animal, is inflated with an aim of maintaining the prosthesis correctly positioned during the gluing of the prosthesis to the abdominal wall, exerting a uniform pressure on all the surface of the prosthesis (8).

17. The positioner according to claim 1 , wherein the chamber (2) in the deflated configuration is folded, rolling two half-parts or portions (2a, 2b) on themselves, one in a clockwise direction and the other in an anticlockwise direction, up to bringing them mutually longitudinally side-by- side.