WO2002009593A1

WO2002009593A1 - Suture reinforcing device

Info

Publication number: WO2002009593A1
Application number: PCT/FR2000/002182
Authority: WO
Inventors: Philippe Maingault
Original assignee: Les Laboratoires Brothier
Priority date: 2000-07-28
Filing date: 2000-07-28
Publication date: 2002-02-07
Also published as: AU2000270100A1

Abstract

The invention concerns a device comprising a polysaccharide material fabric, at least partly coated with a polymer-based hydrophilic and water soluble material, designed to provide water tightness and shape to the fabric. The fabric and the alginate coating material can be respectively calcium alginate and alginate. The invention is very applicable to suture reinforcements, in the field of thoracic surgery.

Description

SUTURE REINFORCEMENT DEVICE

In surgery, and in particular in thoracic surgery, it is advisable, after certain operations such as a partial resection of an organ or an eventration, to suture the severed tissues using staples or wires, for example.

A suture staples, to use this example, takes place using a gripper stapler _^ ^'having two branches, one with charging function of staples and the other acting as an anvil. To suture the two lips of a wound, for example, one takes the two lips between the two branches of the forceps and then activates the latter, thereby causing a row of staples closing the wound to be laid. With the staples used, which are generally metallic, there is a significant risk of tissue rupture. To overcome this drawback, it is known to use suture reinforcement devices. There are mainly two types.

The first type of suture reinforcement devices consist of collagen films. They are absorbable and promote wound healing. However, collagen poses viral safety problems and its use is currently prohibited by certain legislations. In addition, collagen-based devices are difficult to shape, so that they can only be used in sheets which must be tied to the branches of the stapling pliers, prior to the installation of the staples.

The second type of suture reinforcement devices consist of PTFE (polytetrafluoroethylene) sheaths. It is an inert thermoplastic material, easy to shape. The PTFE sheaths therefore thread easily on the branches of the stapling pliers. However, these sheaths have several drawbacks. On the one hand, they are not absorbable and, like any prosthesis, are subject to bacterial contamination. On the other hand, the tissue perforations created by the staples let blood and air pass, which can prove to be annoying, in the case of a pulmonary resection in particular. Finally, PTFE has no biological activity and therefore does not promote wound healing. However, suture reinforcement devices should, in addition to good mechanical strength, have an effective action to promote hemostasis, stopping the passage of air (aerostasis) and scarring.

The present invention provides a generally more satisfactory suture reinforcement device than those of the prior art.

To this end, the invention relates to a suture reinforcement device comprising a fabric of polysaccharide-based material and means for sealing the tissue.

Advantageously, means are provided for shaping the fabric.

Thanks to this, the device can be easily shaped into a sheath, for example, to be fitted onto a branch of stapler pliers of suture.

In a particular embodiment, the means for sealing the fabric are arranged to make the fabric waterproof in a liquid medium.

Thanks to this, the tissue becomes tight in contact with blood.

Advantageously, the fabric is coated at least partially with a hydrophilic material intended to seal the fabric.

Advantageously also, the fabric coating material is water-soluble.

On contact with blood, the coating material liquefies and becomes charged with biological fluid. Thus, thanks to molecular mobility and swelling by absorption of biological fluid, the coating material completely covers the tissue and, if necessary, envelops the staples. It closes.! thus all the interstices of the fabric and the perforations of the staples. After its placement on the sutured tissue, the device becomes completely waterproof, and thus fully plays its aerostatic and hemostatic role.

In another embodiment, the means for sealing the fabric comprise a waterproof material completely covering the fabric. Advantageously, the fabric is coated at least partially with a material based on a polymer intended to seal and shape the fabric.

The coating material therefore plays a dual role. On the one hand, it contributes to making the device waterproof and, on the other hand, it gives it sufficient mechanical strength for its shaping.

Advantageously, the polymer comprises a polysaccharide, without excluding a protein.

Preferably, the polymer comprises at least one of the elements of the group comprising alginate and hyaluronic acid.

More preferably, the fabric is made of an alginate-based material.

The fabric may consist of a knitted fabric or a woven tablecloth.

The invention will be better understood using the following description of the suture reinforcement device of the invention, according to two particular embodiments, with reference to the appended drawing in which:

- Figure 1 shows a diagram of a suture stapler and two suture reinforcement devices, according to one of the embodiments;

FIGS. 2 to 8 represent the successive stages in the manufacture of one of the suturing devices of FIG. 1 and

- Figure 9 shows the successive stages of manufacture of the suturing device, according to the other embodiment.

The suture reinforcement devices 1, 2, shown in FIG. 1, each consist of a knitted sheath, in other words in mesh fabric, in jersey, intended to be fitted onto a branch 4, 5 of a stapling pliers. suture 3, in this case the forceps sold under the reference MULTIFIRE GIA 80 by the company Auto Suture.

The suture stapler forceps 3 comprises two branches 4, 5, one 4 acting as a staple loader and the other 5 acting as an anvil. The two branches 4, 5 here have a generally parallelepiped shape. To suture two sectioned parts, after having fitted the devices 1 and 2 respectively on the charger branch 4 and on the anvil branch 5 of the clamp 3, the two parts are taken sectioned between the two branches 4, 5 of the clamp 3 and the latter is actuated, thereby placing a row of staples connecting the two parts.

The fabric of each suture reinforcement device 1 (2) is made of calcium alginate and partially coated with a polymer-based coating material, in this case alginate.

The coating alginate is waterproof, water-soluble and hydrophilic. Thanks to these properties, when the device 1 (2) is in a liquid medium, and in particular in contact with the blood, the coating alginate is intended to soften and to absorb biological liquid, by swelling, which in turn allows it to spread over the entire surface of the fabric and completely cover it, thus ensuring the air and liquid tightness of the device 1 (2).

In addition, the coating alginate gives the fabric a certain rigidity, allowing it to be shaped. The device 1 (2) is here in the form of a sheath of parallelepiped shape, complementary to that of the branch 4 (5) of the suture clip 3 on which it is intended to be fitted.

The coating alginate thus plays a double role. On the one hand, it is intended to ensure the tightness of the device 1 (2) and, on the other hand, it allows it to be shaped as a parallelepiped sheath.

The method of manufacturing the device 1, intended to be fitted onto the charger branch of the clamp 3, will now be described.

To manufacture the device 1, a linear knitting loom is used which is supplied with calcium alginate fibers. Using this loom, a tubular knitted fabric 6 is made of jersey (Figure 2). The diameter of the knit is such that its perimeter, in cross section, is substantially equal to that of the branch 4 of the suture clip 3 on which the device 1 is intended to be fitted. In this case, for the device 1, intended to be fitted on the charger branch 4, the diameter of the sheath must be equal to 15 mm. For device 2, intended to be fitted on the anvil branch 5, the diameter of the sheath should be equal to 13 mm.

The knitted fabric 6 is put on a shape 7, as shown in FIGS. 3 and 4. The shape is made of non-stick material, in this case of material of the registered trademark teflon, and reproduces the shape of the branch 4 of pliers suture 3, on which the device 1 is intended to be fitted. Then immerse the form 7 dressed with the knitted fabric 6, in a bath 8 containing a 3% aqueous solution of alginate ester, in order to coat the knitted fabric 6 (FIG. 5).

The form 7, dressed in the knitted fabric 6, is then removed from the bath 8, by an upward drive movement, and the knitted fabric 6 is scraped, using flexible scrapers 9 (FIG. 6). The excess coating alginate solution is thus eliminated, so that the coating material only partially covers the knitted fabric 6.

In a drying oven here at 45 ° C (Figure 7), the partially coated knitted fabric 6 is dried with hot air, which stiffens as it dries. The knit 6 thus takes the form of a parallelepiped sheath, having a certain rigidity, of shape complementary to that of the branch 1 of the suture clip 3 on which the device 1 is intended to be fitted. This sheath constitutes the device 1.

Finally, the device 1 is removed from the form 7, by pushing it using stops 10 (FIG. 8).

The method of manufacturing the device 2, intended to be fitted onto the anvil branch of the clamp 3, is analogous to the method which has just been described.

The use of suture reinforcement devices 1, 2 will now be explained, in a particular example consisting in suturing the two lips of a wound.

The devices 1 and 2 are put on beforehand on the charger branch 4 and on the anvil branch 5 of the forceps 3. The two lips of the wound are taken between the two arms 4, 5 of the forceps 3 and then the latter is actuated. ci by causing a row of staples closing the wound to be placed. The reinforcing devices 1, 2 are thus stapled against the wound, on either side of it, and strengthen it during healing. Then the branches 4, 5 are removed from the devices 1, 2, by cutting the latter lengthwise, in the part opposite that stapled to the fabrics.

The alginate, present in the fabric and in the coating material, has intrinsic properties which are particularly advantageous for sutures. On the one hand, it facilitates tissue healing, by activation of the cells involved in this phenomenon. On the other hand, it gives the devices good mechanical resistance to reinforce the sutured wound during healing. It is also hemostatic and absorbable.

On contact with the blood, the coating alginate softens and becomes charged with biological fluid, so that it spreads over the entire surface of the tissue of the device and envelops the staples, thus closing all the interstices of the tissue and the perforations created by staples. Thanks to this, the devices 1, 2 become waterproof and therefore prevent the passage of biological liquids and air through the interstices of the tissue and the perforations of the staples. The devices 1, 2 thus fully play their hemostatic and aerostatic role.

In another embodiment, instead of being in a sheath, the device consists of a flat compress 18, of rectangular shape.

The method of manufacturing the device 18 will now be described, with reference to FIG. 9.

We take a linear knitting loom 11 which is supplied with calcium alginate fibers. With the help of this loom, a flat strip 12 of jersey knit is made, here of a width equal to five centimeters, and the knitted strip 12 is wound around a roller.

The knitted strip 12 is unwound and immersed in a bath 13 containing a 3% aqueous solution of alginate ester in order to coat the knitted fabric 12. Then the coated knitted strip 12 is taken out of the bath 13 and it is passed between two cold calender rollers 14, 15. This eliminates the excess coating alginate solution, so that the knitted fabric 12 is only partially covered with the d-based coating material. alginate.

The knitting is then passed through a hot air oven 16, here 45 ° C, ^'in order to dry and so stiffen.

At the exit of the oven 16, using a cutting device 17, the knitting strip 12 is cut, lengthwise, in order to obtain a plurality of suture reinforcement pads 18, here format 5cmX5cm. Instead of being made of calcium alginate, the fabric of the suture reinforcement device could be of any other material based on alginate and more generally based on polysaccharide.

The coating material could more generally be based on a polymer intended to ensure the sealing and the shaping of the device. The polymer could comprise alginate, hyaluronic acid, or more generally a polysaccharide.

The fabric could be completely covered with a waterproof coating material such as a material based on alginate or hyaluronic acid, or any other waterproof polymer.

Instead of being in jersey, the knitting could be in any other type of mesh. Finally, the fabric could be a woven tablecloth.

It will be noted that the tissue of the suture reinforcement device which has just been described constitutes an excellent support for cell culture, thanks to its hydrophilicity and to its mechanical resistance.

Claims

1 - Suture reinforcement device comprising a fabric of polysaccharide-based material and means for sealing the tissue.

2- Device according to claim 1, wherein there is provided means for shaping the fabric.

3- Device according to one of claims 1 and 2, wherein the means for sealing the fabric are arranged to make the fabric waterproof in liquid medium.

4- Device according to one of claims 1 to 3, wherein the fabric is coated at least partially with a hydrophilic material intended to ensure the tightness of the fabric.

5- Device according to one of claims 1 to 4, wherein the fabric coating material is water soluble.

6- Device according to one of claims 1 and 2, wherein the means for sealing the fabric comprises a layer of waterproof material completely covering the fabric.

l Device according to one of claims 1 to 6, wherein the fabric is coated at least partially with a polymer-based material intended to ensure the sealing and shaping of the fabric.

8- Device according to claim 7, wherein the polymer comprises a polysaccharide.

9- Device according to one of claims 7 and 8, wherein the polymer comprises at least one of the elements of the group comprising alginate and hyaluronic acid.

10- Device according to one of claims 1 to 9, wherein the fabric is a knitted fabric.

11 - Device according to one of claims 1 to 9, wherein the fabric is a woven web. 12- Device according to one of claims 1 to 11, wherein the. fabric is made of alginate material.

13- Device according to one of claims 1 to 12, wherein the fabric is shaped sheath.

14- Use of the device according to one of claims 1 to 13, as a cell culture support.