NZ578314A

NZ578314A - Tube for enteral nutrition

Info

Publication number: NZ578314A
Application number: NZ578314A
Authority: NZ
Inventors: Reinhold Wolkenstorfer; Thomas Horbach
Original assignee: Nutricia Nv
Priority date: 2006-12-11
Filing date: 2007-12-05
Publication date: 2012-03-30
Also published as: EP1935355A1; RU2009125467A; EP2099370A2; EP1935355B1; RU2463009C2; AU2007331740B2; WO2008071330A3; WO2008071330A2; PL2099370T3; PL1935355T3; AU2007331740A1; EP2099370B1

Abstract

Disclosed is a tube for percutaneous endoscopic gastrostomy, said tube having at least on or in surface regions of the tube an antiseptically or antimicrobially acting compound that releases metal ions or colloidal metal wherein said compound is in the form of nanoparticles.

Description

RECEIVED at IPONZon Ifi.lnlv 7011 C:\NRPortbl\DCC\TXB\3621239 1. DOC-13/07/20U INTELLECTUAL PROPERTY OFFICE OF N.Z.

JUL 2011 -i- rfcfived Tube for enteral nutrition The invention relates to a tube for enteral feeding, in particular a PEG tube (PEG = percutaneous endoscopic gastrostomy).

Percutaneous endoscopic gastrostomy is the application of a feeding probe into 5 the stomach, through the abdominal wall, with the aid of an endoscope. A gastroscope is routinely used for this purpose, i.e. a flexible optical instrument comprising a lens and an eyepiece or an electronic image transmission device. A PEG tube (also termed PEG probe) is used for enteral feeding, i.e. feeding directly via the stomach/intestinal tract. A liquid, or food in liquid or thin-paste form, can 10 be administered via the PEG tube.

The PEG tube is one of the most frequently employed means for long-term enteral feeding of patients who, owing to particular illnesses, are no longer able to take in sufficient food orally.

The positioning of a PEG tube is usually effected with the aid of the so-termed 15 filament pull-through method. In this method, the physician pushes a gastroscope into the stomach via the mouth and the oesophagus. Air is blown into the stomach, causing it to distend, such that it is more easily examined. A hollow needle is then inserted through the abdominal wall, under endoscopic control, into the stomach through the abdominal wall. The hollow needle contains an inserted 2 o small plastic tube. The hollow needle is then removed and a filament is introduced into the stomach through the small plastic tube that remains. This filament can then be gripped by means of a pincer, which the physician has introduced via the gastroscope. The filament, pincer and gastroscope are then drawn out via the oesophagus and the mouth. The PEG tube can then be connected to the end of 2 5 the filament protruding from the mouth and, by pulling on the other end of the filament, the probe is brought into the stomach via the mouth and oesophagus, and drawn partially through the abdominal wall. Plates on the PEG tube position it in relation to at IPON7 on Ifi.lnlv 90 INTELLECTUAL PROPERTY OFFICE OF N.Z.

JUL 2011 RECEIVED 07-09-'09 09:57 FROM- T-341 P008/020 F-773 the abdominal wall and the stomach. The protruding end of the PEG tube can then be connected to means for supplying food.

Although percutaneous endoscopic gastrostomy has become established to a large 5 extent, nevertheless for a long time there has continued to be a considerab/e risk of infection, which can extend into the two-digit percentage range. Thus, a percentage rate of 5 -15 % is still being reported in the year 2000 for peristaltic infection alone (C.H. User, DMW125, 805). In particular, necrosis and mycosis occur.

Various attempts to prevent infections caused by PEG tubes are known in the prior art. Thus, surfaces that are as smooth as possible are used on the PEG tube, as are hydrophilic surfaces, as well as hydrogels, heparin and heparioid. Monoclonal antibodies are also used in the case of catheters. There are studies relating to the prevention of infections by means of antibiotics in the case of PEG.

However, antibiotics also have disadvantages; in particular, the antimicrobial effect can decline after just 24 hours, and the effect is not locally limited. In addition, the application spectrum is limited and the patient can develop resistance. Antibiotics are also disadvantageous in terms of cost.

US 2004/0220534 A1 describes, in particular, a stomach probe having a wall made of a hydrophobic polymer, there being applied to an outer surface of the wall a hydrophilic polymer having an antimicrobial compound consisting of a phosphorus-based glass in which a metal, in particular silver ions, is dispersed. Such a teaching 25 does not constitute subject-matter of the present invention.

US 6,060,000 describes, in particular, catheters with the use of oligodynamic iontophoresis. For the purpose of achieving an antibacterial effect, silver ions are delivered into the surrounding fluid with the aid of an electric potential. The wall of 30 the catheter includes delimited regions, fbr example in the form of elongate strips, which contain electrodes for the purpose of generating the said electric potential.

RECEIVED at IPONZ on 24 January 2012 C:\NRPortbl\DCC\TXB\4104363_l.DOC - 19/1/12 WO 95/04564 describes an enteral feeding probe having an outer surface coated with Parylene.

US 2001/0051669 A1 describes medical equipment such as, in particular, catheters or the like, having a slip layer to reduce friction.

The invention seeks to provide a tube for enteral feeding in which the risk of infection is reduced by simple means.

For this purpose, the invention provides a tube having an antiseptic and/or antimicrobial compound, which is applied to or introduced into at least selected surface regions of the tube.

According to the invention, there is provided a tube for percutaneous endoscopic gastrostomy, said tube having at least on or in surface regions of the tube an antiseptically or antimicrobially acting compound that releases metal ions or colloidal metal wherein said compound is in the form of nanoparticles.

In one embodiment of the invention, the tube has a coating comprising Parylene 15 or Polyparylene. The antiseptically or antimicrobially acting compound may be mixed into the coating or be in a layer of material applied to the coating.

In one embodiment the compound is distributed homogeneously in the material of the tube, over its thickness.

In one embodiment the compound is diffusibly distributed in the material of the 20 tube.

Metal salts, such as silver salts, that release metal ions (silver ions) are particularly suitable as a compound for this purpose. Compounds that release colloidal silver can also be used.

RECEIVED at IPONZ on 24 January 2012 C:\NRPortbl\DCC\TXB\4104363_l.DOC - 19/1/12 According to a preferred development of the invention, the compound that releases the metal ions or colloidal metal is in the form of so-termed nanoparticles, i.e. particles having dimensions in the nano range.

Embodiments of the invention have the following advantages, in particular: a 5 very broadband antimicrobial spectrum; a high level of activity against organisms and variants in very small colonies; a long-lasting activity over weeks, months or even years; no induction of resistance; no stimulation of risk of thrombosis or cytotoxicity; no alteration of the material properties of the tube plastic; in addition, low cost.

According to a preferred development, the tube is not fully provided with antiseptic and/or antimicrobial substance in all regions, but only in partial regions. These partial regions of the tube preferably extend in striate form, in particular in the longitudinal direction of the tube, such that simple production, by means of extrusion methods, is rendered possible. A preferred development 15 makes provision whereby the striate surface regions have a zigzag form or waved form. A uniform delivery and distribution of the metal ions is thereby promoted. Striate regions comprising the antimicrobial compound and having a width that varies over the longitudinal extent or, also, that are arranged helically, can also be provided for this purpose.

In order to enhance the possibilities for inspection, the tube can be designed, preferably, to have, in part, transparent regions that extend in the longitudinal direction, for example in that its plastic material is transparent.

As noted above, an embodiment of the invention provides for a Parylene coating on the surface of the tube. This Parylene coating can be provided on the outer 25 surface and/or the inner surface of the tube. An anti-crustation layer can also be provided, in addition to or as an alternative to the Parylene coating.

RECEIVED at IPONZ on 24 January 2012 C:\NRPortbl\DCC\TXB\4104363_l.DOC - 19/1/12 A further preferred development of the invention provides for a tube made, for example, of polyurethane or silicone, which is provided with a Parylene coating on the outer surface and/or the inner surface, a further coating, of a material that releases metal ions, being applied over the Parylene coating. The metal ions 5 can be, for example, silver ions or titanium ions. A further coating, which releases colloidal silver, can also be provided.

Preferably, Parylene C and/or Parylene N is/are used. It has been found that, for the application intended here, Parylene C has a particularly good chemical resistance and a slight antibacterial effect. Parylene N, on the other hand, is 10 distinguished by a particular slipperiness. Also suitable is a mix of Parylene C and Parylene N.

In the case of all the exemplary embodiments described here, the layer thickness of the optional Parylene coating can preferably be in the pm range, in particular in the range from 0.2 to 10 pm, particularly preferably in the range 15 from 1 to 5 pm.

In this case, a further coating, of a material that releases Ag-ions or Ti-ions or colloidal silver, can be additionally applied to the Parylene coating already mentioned above. This applies both to the outer coating of the tube and to its inner coating. Techniques for applying such coatings are known as such from 20 other fields, for example from the general technique of metal coatings.

The concentration and/or layer thickness of the antiseptically or antimicrobially acting substances that release metal ions or colloidal silver is/are preferably to be so dimensioned that they are active, in particular, in the first 20 days of the application, for as long as the risk of infection exists.

The tubes described here are preferably composed of polyurethane or silicone. Multilayer tubes can also be provided, for example two-layer tubes having a somewhat thinner outer layer, in which or on which the antiseptically or RECEIVED at IPONZ on 24 January 2012 C:\NRPortbl\DCC\TXB\4104363_l.DOC - 19/1/12 antimicrobially acting substances are arranged, while a preferably somewhat thicker inner tube layer can be free from same. Such a multilayer tube structure can be produced easily by the extrusion method. The layer arrangement can also be the inverse of that described above.

The invention also teaches generally the use of ionized titanium, i.e. a compound that releases titanium in ionic form, as an antiseptically or antimicrobially acting substance that releases metal ions. This use relates, in particular, to PEG tubes.

An exemplary embodiment of the invention is explained more fully in the 10 following with reference to the non-limiting drawing.

Figures 1, 2 and 3 each show, schematically, a portion of a PEG tube. Figure 4 shows a section through an exemplary embodiment of a tube for enteral feeding.

In the figures, components that correspond to one another or have a similar function are denoted by the same references.

Figures 1, 2 and 3 shows a short portion of a PEG tube 10 made of PU. Silver nanoparticles 14 have been introduced into selected regions 12 of the tube. The regions 20 therebetween are free from such particles.

The regions 12 provided with the nanoparticles containing silver extend from the outer surface 16 of the tube 10 to the inner surface 18.

The concentration of nanoparticles containing silver is such that they continually deliver antibacterially acting silver ions over relatively long periods of time, in particular periods of many days, weeks or months.

Figure 1 shows an arrangement of the regions 12 having the added antibacterial compound, which extend helically (in the form of a helical line) around the 25 longitudinal axis of the tube 10. .07-09-'09 09:58 FROM- T-341 P013/020 F-773 According to Figure 2, the regions 12 having the added antibacterial compound extend in the longitudinal direction of the tube and have a zigzag form or waved form.

According to Figure 3, the corresponding regions 12 are so configured that their width varies in the longitudinal direction of the tube.

The representations are schematic. In reality, the regions having the added antibacterial substance are geometrically so configured that the active metal ions are 10 delivered, to a very large degree, homogeneously by the tube, i.e. the regions carrying the compound are located so close to one another that no gaps remain in respect of the antimicrobial action.

The tube 10 is provided with a coating that prevents the penetration of a polyvidon-is iodine complex agent and/or the penetration of disinfectants into the tube material. Parylene, in particular, is suitable for this coating.

Preferably by means of a coextrusion method, the inner surface 18 of the tube is provided with a layer that is resistant to cytostatics, such that the tube retains its 20 mechanical properties. Parylene, in particular, offers protection against cytostatics.

In particular, Parylene or Polyparylene (trade name) is suitable as a coating material for the tube. Parylene is a polymer from the poly-p-xylylene families.

Rgure 4 shows a section through an exemplary embodiment of a tube 10 for enteral feeding, in particular for PEG. A tube 10a made of polyurethane or silicone constitutes the supporting structure of the tube. Applied to the tube 10a, radially outwards, there is a layer 22 of Parylene, in particular Parylene C or Parylene N or a mix of Parylene C and Parylene N. Applied over the layer 22 there is a further layer 30 24, of an antimicrobially acting material that releases metal ions, the metal ions preferably being silver ions or titanium ions. A colloidal silver, or another RECEIVED at IPONZ on 15 July 2011 C:\NRPortbl\DCC\TXB\3621239_l.DOC-13/07/2011 antimicrobially acting layer that releases colloidal metal, can also be applied instead of the layer 24 or in addition thereto.

The exemplary embodiment according to Figure 4 can be complemented by the application of an analogous coating on the inner surface 18 of the tube 10a, thus there is applied to the inner surface 18, firstly, a coating (analogous to the layer 22) of Parylene C and/or Parylene N, and then, upon the latter on the inside, a further coating (analogous to the coating 24) of a material that releases metal ions and/or colloidal metal.

In Figure 4, the layer thicknesses are not true to scale; rather, the outer layers 10 are shown as being thicker, for the purpose of simplified representation.

In the description hereinbefore and in the claims and the drawing, tubes for enteral feeding, in particular PEG tubes, are shown in general. All described details, features and measures are suitable and applicable both for application in the case of PEG tubes and, quite generally, for application in the case of 15 tubes for enteral feeding.

The reference in this specification to any prior publication (or information derived from it), or to any matter which is known, is not, and should not be taken as an acknowledgment or admission or any form of suggestion that that prior publication (or information derived from it) or known matter forms part of 20 the common general knowledge in the field of endeavour to which this specification relates.

Throughout this specification and the claims which follow, unless the context requires otherwise, the word "comprise", and variations such as "comprises" and "comprising", will be understood to imply the inclusion of a stated integer 25 or step or group of integers or steps but not the exclusion of any other integer or step or group of integers or steps.

C:\NRPortbl\DCC\TXB\362123 9_1.DOC-13/07/2011 RECEIVED at IPONZ on 15 July 2011

Claims

1. Tube for percutaneous endoscopic gastrostomy, said tube having at least on or in surface regions of the tube an antiseptically or antimicrobially acting compound that releases metal ions or colloidal metal wherein said compound is in the form of nanoparticles.

2. Tube for percutaneous endoscopic gastrostomy according to claim 1, characterized in that the compound is distributed homogeneously in the material of the tube over its thickness.

3. Tube for percutaneous endoscopic gastrostomy according to either of claims 1 or 2, characterized in that the compound is diffusibly distributed in the material of the tube.

4. Tube for percutaneous endoscopic gastrostomy according to any one of the preceding claims, characterized in that the tube has a Parylene coating.

5. Tube for percutaneous endoscopic gastrostomy as claimed in claim 4, wherein the Parylene coating comprises Parylene N and/or Parylene C.

6. Tube for percutaneous endoscopic gastrostomy according to claim 4 or 5, characterized in that an antimicrobially acting compound that releases metal ions is mixed into the Parylene coating, or a layer of a material that releases metal ions is applied to the Parylene coating.

7. Tube for percutaneous endoscopic gastrostomy according to claim 6, wherein the released metal ions are silver ions or titanium ions. RECEIVED at IPONZ on 24 January 2012 C:\NRPortbl\DCC\TXB\4104363_l.DOC - 19/1/12 - 10-

8. Tube for percutaneous endoscopic gastrostomy according to any one of claims 4 to 7, characterized by the Parylene coating being on the outer surface and/or inner surface of the tube.

9. Tube for percutaneous endoscopic gastrostomy according to any one of the preceding claims, characterized in that the surface regions extend in striate form in the longitudinal direction of the tube.

10. Tube for percutaneous endoscopic gastrostomy according to claim 9, characterized in that the striate surface regions have a zigzag form, waved form or helical form.

11. Tube for percutaneous endoscopic gastrostomy according to claim 9 or 10, characterized in that the striate surface regions have a varying width.

12. Tube for percutaneous endoscopic gastrostomy according to any one of the preceding claims, characterized in that the tube is at least partially transparent.

13. Tube for percutaneous endoscopic gastrostomy according to any one of the preceding claims, characterized in that the tube is at least partially opaque.

14. Tube for percutaneous endoscopic gastrostomy according to any one of the preceding claims, made of polyurethane or silicone.

15. Tube according to claim 1 and substantially as hereinbefore described with reference to the drawings.