WO2011080785A1

WO2011080785A1 - Biocompatible adhesive material, adhesive surgical prosthesis, and related kit

Info

Publication number: WO2011080785A1
Application number: PCT/IT2010/000376
Authority: WO
Inventors: Massimo Chiaretti; Giovanna Angela Carru; Alessandra Cucina
Original assignee: Universita' Degli Studi Di Roma "La Sapienza"
Priority date: 2009-12-28
Filing date: 2010-08-26
Publication date: 2011-07-07
Also published as: ITRM20090685A1; IT1397273B1

Abstract

The present invention concerns a biocompatible adhesive material comprising or consisting of at least one sheet of carbon nanotubes, or buckypaper. The present invention further concerns an adhesive surgical prosthesis (10; 20), comprising a layer (12; 21) of surgical prosthesis having two surfaces, characterised in that it is provided on one of said two surfaces with one or more elements (11; 22, 23) of such biocompatible adhesive material. The present invention still concerns the uses of the biocompatible adhesive material for the preparation of implantable elements for supporting biological tissues, for the preparation of topic carrier of one or more substances and/or one or more compositions, for the preparation of elements for fixing surgical devices, and for the preparation of adhesive surgical prostheses (10; 20). The present invention furthermore concerns a kit for the preparation of at least one adhesive surgical prosthesis (10; 20).

Description

BIOCOMPATIBLE ADHESIVE MATERIAL,

ADHESIVE SURGICAL PROSTHESIS, AND RELATED KIT

The present invention concerns a biocompatible adhesive material, that is fixable to biological tissues, both animal and human ones, in a simple, atraumatic, atoxic, non-mutagenic, versatile, effective, reliable, safe for patients and inexpensive to manufacture, allowing to speed up the related surgical procedure, avoiding to place the living tissues under traction.

The present invention further concerns the use of the biocompatible adhesive material, a surgical prosthesis made through such biocompatible adhesive material, and a kit for the preparation of such an adhesive surgical prosthesis.

In the following of the description, reference will be made to the biocompatible adhesive material when used:

- as element supporting biological tissues,

- as topic carrier of substances and/or compositions, preliminarily functionalised, e.g., with chemical groups and/or metals and/or pharmacological substances and/or analgesics and/or disinfectants and/or antibiotics and/or pharmacological molecules,

- as element for fixing surgical devices, such as for instance biosensors, catheters, tubes, in vivo, and

- as component for fixing a prosthesis net as surgical prosthesis.

However, it must be understood that the biocompatible adhesive material may be used as element supporting biological tissues, and/or as carrier of any type of substance and/or composition, and/or as element for fixing any surgical device, and/or as component for fixing any surgical prosthesis selected from the group comprising, besides the net, also a foil, a tissue, a nonwoven fabric, a film, a cellular film and a membrane, without so departing from the scope of protection of the present invention.

In many surgical interventions, e.g. of hernioplasty, it is necessary to fix prosthesis (usually made of polypropylene and/or polyethylene and/or either foamed or non foamed polytetrafluoroethylene or PTFE), in particular prosthesis net, on biological living tissues. By way of example, but not by way of limitation, such interventions comprise plastic surgery of inguinal hernia, plastic surgery of incisional hernia, anchoring of ptosic bladder, surgical treatment of prolapse of the pelvic floor, surgical treatment of traumatic rupture of the diaphragm, and plastic surgery of umbilical hernia.

Moreover, in almost all surgical interventions, it is further necessary to carry out a fixing of catheters, tubes and venous/arterial access devices, such as the so-called portacaths.

Presently, fixing of prosthesis nets on biological tissues occurs through use of biological glues and/or use of suture threads.

However, both such techniques suffer from some drawbacks, also rather dangerous for patient's health.

In fact, in case of use of biological glues, there exists a risk related to the possibility that the biological materials used in glue components transmit infectious disease not yet known and hence not diagnosable. Also, such biological glues have high costs.

In case of use of suture threads, sutures may cause trapping of nerve ends which remain strangulated in the suture knot, generating chronic neuralgia difficult to treat, causing chronic-terebrating and disabling pain and great discomfort for patients. Moreover, execution of sutures significantly lengthens time of surgical interventions.

In this context, the solution proposed according to the present invention is introduced, allowing to overcome the aforementioned problems.

It is therefore an object of the present invention to develop a technique that is simple, low cost, biocompatible, fast, atoxic and comfortable for the patient that allows in a simple, versatile, effective, reliable, lasting, safe for patients and economically sustainable for health facilities to fix topic carriers of substances and/or compositions, prostheses and surgical devices to biological tissues, both animal and human ones, allowing to speed up the related surgical procedure.

It is specific subject matter of this invention a biocompatible adhesive material comprising or consisting of at least one sheet of carbon nanotubes, or buckypaper, having two faces.

Always according to the invention, said at least one buckypaper may be functionalised with one or more substances and/or one or more compositions, preferably selected from the group comprising chemical groups, metals, pharmacological substances, analgesics, disinfectants, antibiotics, and pharmacological molecules.

Still according to the invention, at least one of said two faces of said at least one buckypaper may be coated with a removable protective film, preferably of polyethylene.

Furthermore according to the invention, the biocompatible adhesive material may be wrapped in a protective envelope.

It is also specific subject matter of this invention an adhesive surgical prosthesis, comprising a layer of surgical prosthesis having two surfaces, characterised in that it is provided on one of said two surfaces with one or more elements of such biocompatible adhesive material.

Always according to the invention, said one or more elements may be placed along an external perimeter of the layer of surgical prosthesis and/or along a central area of the layer of surgical prosthesis.

Still according to the invention, the layer of surgical prosthesis may be selected from the group comprising a net, a foil, a tissue, a nonwoven fabric, a film, a cellular film and a membrane, the layer of surgical prosthesis being preferably either in reabsorbable material, more preferably selected from the group comprising polypropylene, polyethylene, polyester or either foamed or non foamed PTFE, or in non reabsorbable material.

Furthermore according to the invention, the adhesive surgical prosthesis may be wrapped in a protective envelope.

It is still specific subject matter of this invention the use of said biocompatible adhesive material for the preparation of implantable elements for supporting biological tissues.

It is always specific subject matter of this invention the use of said biocompatible adhesive material for the preparation of topic carrier of one or more substances and/or one or more compositions.

It is still specific subject matter of this invention the use of said biocompatible adhesive material for the preparation of elements for fixing surgical devices, preferably selected from the group comprising biosensors, catheters, and tubes, on biological tissue.

It is always specific subject matter of this invention the use of said biocompatible adhesive material for the preparation of adhesive surgical prostheses as previously described.

It is further specific subject matter of this invention a kit for the preparation of at least one adhesive surgical prosthesis as previously described, comprising at least one layer of surgical prosthesis and at least one sheet of carbon nanotubes or buckypaper.

Always according to the invention, the kit may further comprise at least one sheet of polyethylene.

The advantages offered by the biocompatible adhesive material according to the invention are numerous and significant.

First of all, it is extremely versatile, being usable as element supporting biological tissues, and/or as carrier of any type of substance and/or composition, and/or as element for fixing any surgical device, and/or as component for fixing any surgical prosthesis, allowing innovative prostheses to be made.

Moreover, the bioco mpatible adhesive material according to the invention is sterilisable, workable with scissors, soft, flexible, non reabsorbable, immediately active with no latency time, atoxic, non- mutagenic and, firmly adhering to the biological tissues, it perfectly replaces suture knots (eliminating the risk of trapping nerve ends which could cause long-lasting neuralgia to the patient, difficult to treat), and it does not use biological glues (which could transmit presently unknown diseases). In this regard, the biocompatible adhesive material according to the invention is 100 times more adhesive than the best types of implantable adhesive prosthesis tissue presently in use, such as the Parietene Progrip® manufactured by the French company Sofradim Production. Still, the biocompatible adhesive material according to the invention is usable in any type of intervention in general surgery and specialised surgery, such as for instance in surgery of inguinal hernia, of incisional hernia, for urinary incontinence, for traumatic injuries of the diaphragm, with both laparoscopic and laparotomic techniques, in cardiac surgery, in ophthalmology, in otolaryngology, in haematology, in neurosurgery, in orthopedic surgery, in gynaecology, in urology, in vascular surgery, in thoracic surgery, and also in surgery in the veterinary field.

The biocompatible adhesive material according to the invention allows the proper and long-lasting positioning of prostheses made with all the other non bioadhesive materials, thus allowing to speed up surgical procedure, shortening the time of occupancy of operating room and hence obtaining an economic and management saving, and allowing, with the same time length condition, to make a larger number of surgical interventions per operating session.

The significant reduction of the duration of the surgical intervention allow to extend such interventions also to patients with critical cardiological and/or pneumological conditions who otherwise could not be subject to operation.

Furthermore, the surgical prosthesis according to the invention offers numerous direct and indirect economic advantages. First of all, it is less expensive than biological glues. Moreover, by shortening the time of occupancy of operating room, it allows to cut down the related management costs: with the same working hours, it is possible to make a larger number of interventions. Still, by eliminating risks related to the use of biological glues and/or the use of suture threads, it allows to cut down the expenses due to the high costs of treatment of complications.

The present invention will be now described, by way of illustration and not by way of limitation, according to its preferred embodiments, by particularly referring to the Figures of the enclosed drawings, in which:

Figure 1 shows a first embodiment of an adhesive surgical prosthesis according to the invention; and

Figure 2 shows a second embodiment of an adhesive surgical prosthesis 10 according to the invention.

In the Figures, identical reference numbers are used for alike elements.

The surgical prosthesis according to the invention exploits the so- called "gecko effect" of the sheets of carbon nanotubes known with the term of "buckypaper". Such sheets are made through thin film deposition of carbon nanotubes, both Single Wall Carbon NanoTubes, or SWCNT, and Multi Wall Carbon NanoTubes, or MWCNT. The buckypaper appears as a blackish material, of consistency as that of the cellulose paper, flexible, very lightweight and of thickness of the order of micrometers. The buckypaper comprises a rough and opaque face and an opposed smooth, shiny and bright face.

The inventors have discovered that adhesivity of such buckypapers is also present in biological context (property of bioadhesivity). In particular, carbon nanotubes have these bioadhesivity property both on the rough and opaque face and on the smooth, shiny and bright face, although in a different manner: the former is intensely bioadhesive, while the latter has 20% of bioadhesivity as measured on the former. Moreover, when soaked with interstitial fluid, the buckypaper gets very soft and flexible and hence it adapts to the biological surfaces onto which is applied.

The inventors have developed a number of applications of the buckypaper in surgical field.

First of all, the buckypaper may be used as such as element for supporting biological tissues even for wide surgical surfaces. In this case, the buckypaper appears as a material workable with scissors. It is advantageously wrapped in a pre-sterilised package, that must be sterilely opened and the material is preferably shaped ad hoc with scissors, either wetted in saline solution and placed in the chosen location or applied dry.

Moreover, the buckypaper may be also used as topic carrier of substances and/or compositions. To this end, it may be functionalised, either before being applied or after having been applied, e.g. with chemical groups and/or metals and/or pharmacological substances and/or analgesics and/or disinfectants and/or antibiotics and/or pharmacological molecules. Such substances and/or compositions are advantageously dissolved in solution and hence deposited on the buckypaper by filtration/aspiration on filter paper.

Both in the case where the buckypaper is used as supporting element and in the case where it is used as topic carrier of substances and/or compositions, one or both of its two faces may advantageously be protected by a film removable before application. In this regard, it is useful but not indispensable to apply at least on the rough face of the buckypaper an "insulating" film (e.g. of polyethylene) for allowing the correction of possible positioning errors (e.g. in laparotomic surgery).

Both in the case where the buckypaper is used as supporting element and in the case where it is used as topic carrier of substances and/or compositions, the operator (i.e., the surgeon) may suitably shape, preferably with scissors, a sheet of buckypaper, suitably modelling it on the basis of the patient's specific anatomical size. Alternatively, in the sterile envelope containing one or more sheets of buckypaper at least one sheet of polyethylene (e.g. having size of 10x20 cm) is advantageously present that may serve as model for exactly cutting the necessary outline to apply to the patient, and after the model has been shaped, the latter is applied on a sheet of buckypaper obtaining a supporting element or a topic carrier of precise shape and size that may be applied to the patient, without undergoing the risk of having to then remove it and to further trim it because of a possible imprecision of the not measured cutting that is executed, consequently reducing the bioadhesive capability of the buckypaper.

Furthermore, the buckypaper may be used as component for fixing surgical prostheses, such as nets, foils, tissues, nonwoven fabrics, films, cellular films and membranes, to biological living tissues, both animal and human ones.

By way of example, and not by way of limitation, it may be observed in Figure 1 a first embodiment of an adhesive surgical prosthesis 10 according to the invention, consisting in a layer 12 of prosthesis net (e.g. of polypropylene) for the treatment of inguinal hernia, shaped in a conventional way, provided on one of the two surfaces of a plurality of elements 11 of buckypaper preferably placed along the external perimeter of the layer 12 of the prosthesis net. In particular, the number of the elements 11 may vary depending on the extent of the surgical surface, e.g. they could be more numerous than what shown in Figure 1 in case of a prosthesis for obese macrosoma and less numerous in case of a prosthesis for young and slim patient. In this regard, the shape of the elements 11 may vary; by way of example, and not by way of limitation, the elements 11 may be shaped as squares or rectangles. Also the size of the elements 11 may vary depending on the prosthesis surface to implant (i.e. on the area and shape of the layer 12 of prosthesis net).

The elements 11 may be advantageously applied with either glue or direct hot deposition, or with any other possible either sterile or non sterile industrial technique, on the related surface of the layer 12 of prosthesis net to implant. The adhesive surgical prosthesis 10 of Figure 1 may be both made by the surgeon during the intervention and preliminarily made in laboratory. In the latter case, once the elements 11 have been applied, the adhesive surgical prosthesis 10 is advantageously subjected to a sterilisation with gas, ethylene oxide or in autoclave, and finally to a suitable packaging, on the basis of the surgical and technological needs and satisfying relevant regulations.

Figure 2 shows a second embodiment of an adhesive surgical prosthesis 20 according to the invention, consisting in a layer 21 of prosthesis net for abdominoplasty for abdominal incisional hernia, shaped in a conventional way. The layer 21 may be either in non reabsorbable material, e.g. polypropylene, polyethylene, polyester or either foamed or non foamed PTFE, or in reabsorbable material, e.g. decellularised porcine tissue. In particular, the layer 21 may be also pre-shaped and the surgeon may select it within a set of layers of increasing size provided within sterile containers. The layer 21 is provided on one of the two surfaces with a first plurality of elements 22 of buckypaper placed along the external perimeter of the layer 21 of the prosthesis net and with a second plurality of elements 23 of buckypaper placed along the central area of the layer 21 of the prosthesis net, so as to make the layer 21 uniformly adhere to the underlying biological support. In particular, the elements 22 and 23 make the layer 21 bioadhesive on all the deep surface in contact with the peritoneal plane or with the fascial plane of the rear vaginae of recta sutured on the midline, as in the plastic surgical intervention of the Rives abdominal wall, towards the patient's abdominal cavity. Also in this case, the number, shape and size of the elements 22 and 23 may vary depending on the area and shape of the layer 21 of prosthesis net to implant.

In case of small prosthesis surfaces to implant (such as for instance in case of plastic intervention of inguinal hernia), the elements of buckypaper are preferably placed along the external perimeter of the surgical prosthesis.

In case of large prosthesis surfaces to implant (such as for instance in case of abdominal incisional hernias, epigastric hernias and diastasis of rectus muscles), the elements of buckypaper are preferably placed on several concentric lines following the outline of the prosthesis layer. In case of hernia prosthesis, such concentric lines of elements of buckypaper allow to prevent the sliding of the viscera and to form a wide support around the hernia portal. Preferably, one or more elements of buckypaper may be placed along a central line of the deep (internal) face of the surgical prosthesis.

Also in the case where prostheses are made, the exposed faces (usually the rough faces) of the elements of buckypaper may be advantageously protected by a removable film, also for allowing the prostheses to be rolled up on themselves as cylinders, so as to be capable to be introduced within the patient's body through trocar (e.g. in laparoscopic surgery of incisional hernias). Preferably, the rough face of the elements of buckypaper, used for making prostheses to employ in laparoscopic surgery, is provided with an "insulating" film (e.g. of polyethylene) for avoiding that the elements adhere to tissues not in the due location and hence allowing the correction of possible positioning errors with no need for detaching and repositioning the prosthesis with prolongation of the surgical time.

Still, the buckypaper may be used as element for fixing surgical devices in vivo, such as for instance biosensors, catheters, tubes. By way of example, and not by way of limitation, in case of fixing of intracardiac catheters, the buckypaper is extracted from a protection sheathing the same until it reaches the implant-anchorage location, by using an introducer element that, introduced into a channel parallel to the catheter, allows the buckypaper to exit in proximity to the catheter tip and to adhere to the tissue fixing the same catheter tip in the correct location.

The inventors further have made a kit for the preparation of an adhesive surgical prosthesis according to the invention including at least one layer of surgical prosthesis selected from the group comprising a net, a foil, a tissue, a nonwoven fabric, a film, a cellular film and a membrane, and at least one sheet of buckypaper, the faces of which are preferably protected by a removable film before application. Thus, the user, usually a surgeon, may make an adhesive surgical prosthesis by suitably shaping, preferably by cutting, a layer of surgical prosthesis and by cutting the sheet of buckypaper obtaining from the same elements which he may place on one of the surfaces of the thus shaped prosthesis. The kit may further comprise, alternatively or in combination with the sheet of buckypaper, a plurality of already cut elements of buckypaper. Still, the kit may further advantageously comprise at least one sheet of polyethylene (e.g. having size of 10x20 cm) that may serve as a model as illustrated before.

The preferred embodiments have been above described and some modifications of this invention have been suggested, but it should be understood that those skilled in the art can make variations and changes, without so departing from the related scope of protection, as defined by the following claims.

Claims

1. Biocompatible adhesive material comprising or consisting of at least one sheet of carbon nanotubes, or buckypaper, having two faces.

2. Biocompatible adhesive material according to claim 1, characterised in that said at least one buckypaper is functionalised with one or more substances and/or one or more compositions, preferably selected from the group comprising chemical groups, metals, pharmacological substances, analgesics, disinfectants, antibiotics, and pharmacological molecules.

3. Biocompatible adhesive material according to claim 1 or 2, characterised in that at least one of said two faces of said at least one buckypaper is coated with a removable protective film, preferably of polyethylene.

4. Biocompatible adhesive material according to any one of the preceding claims, characterised in that it is wrapped in a protective envelope.

5. Adhesive surgical prosthesis (10; 20), comprising a layer (12; 21) of surgical prosthesis having two surfaces, characterised in that it is provided on one of said two surfaces with one or more elements (11 ; 22, 23) of biocompatible adhesive material according to any one of claims 1 to 3.

6. Adhesive surgical prosthesis (10; 20) according to claim 5, characterised in that said one or more elements (11; 22) are placed along an external perimeter of the layer (12; 21) of surgical prosthesis and/or along a central area of the layer (21) of surgical prosthesis.

7. Adhesive surgical prosthesis (10; 20) according to claim 5 or 6, characterised in that the layer (12; 21) of surgical prosthesis is selected from the group comprising a net, a foil, a tissue, a nonwoven fabric, a film, a cellular film and a membrane, the layer (12; 21) of surgical prosthesis being preferably either in reabsorbable material, more preferably selected from the group comprising polypropylene, polyethylene, polyester or either foamed or non foamed PTFE, or in non reabsorbable material.

8. Adhesive surgical prosthesis (10; 20) according to any one of claims 5 to 7, characterised in that is wrapped in a protective envelope.

9. Use of the biocompatible adhesive material according to any one of claims 1 to 4 for the preparation of implantable elements for supporting biological tissues.

0. Use of the biocompatible adhesive material according to claim 2 or to any one of claims 3 and 4, when depending on claim 2, for the preparation of topic carriers of one or more substances and/or one or more compositions.

1 1. Use of the biocompatible adhesive material according to any one of claims 1 to 4 for the preparation of elements for fixing surgical devices, preferably selected from the group comprising biosensors, catheters, and tubes, on biological tissue.

12. Use of the biocompatible adhesive material according to any one of claims 1 to 4 for the preparation of adhesive surgical prostheses (10; 20) as defined according to any one of claims 5 to 8.

13. Kit for the preparation of at least one adhesive surgical prosthesis (10; 20) as defined according to any one of claims 5 to 8, comprising at least one layer (12; 21) of surgical prosthesis and at least one sheet of carbon nanotubes or buckypaper.

14. Kit according to claim 13, characterised in that it further comprises at least one sheet of polyethylene.