EP4398861A1 - Cathéter pour alimentation percutanée - Google Patents

Cathéter pour alimentation percutanée

Info

Publication number
EP4398861A1
EP4398861A1 EP22773152.8A EP22773152A EP4398861A1 EP 4398861 A1 EP4398861 A1 EP 4398861A1 EP 22773152 A EP22773152 A EP 22773152A EP 4398861 A1 EP4398861 A1 EP 4398861A1
Authority
EP
European Patent Office
Prior art keywords
catheter
tube
section
retaining structure
stretchable section
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
EP22773152.8A
Other languages
German (de)
English (en)
Inventor
Steffen BAUMGART
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Fresenius Kabi Deutschland GmbH
Original Assignee
Fresenius Kabi Deutschland GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Fresenius Kabi Deutschland GmbH filed Critical Fresenius Kabi Deutschland GmbH
Publication of EP4398861A1 publication Critical patent/EP4398861A1/fr
Pending legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0015Gastrostomy feeding-tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J15/00Feeding-tubes for therapeutic purposes
    • A61J15/0026Parts, details or accessories for feeding-tubes
    • A61J15/003Means for fixing the tube inside the body, e.g. balloons, retaining means
    • A61J15/0034Retainers adjacent to a body opening to prevent that the tube slips through, e.g. bolsters

Definitions

  • the invention relates to a catheter for percutaneous feeding according to the preamble of claim 1.
  • Percutaneous feeding in particular percutaneous endoscopic gastrostomy (PEG) is an endoscopic medical procedure in which a tube is inserted into a patient's lumen, particularly the stomach, through the abdominal wall. PEG may be used for feeding when oral intake is not adequate. Thus, although nutrition is not provided via the mouth, the natural digestion process is maintained.
  • PEG percutaneous endoscopic gastrostomy
  • the tube usually provides a certain amount of flexibility to allow movements of the patient.
  • the distance of the outer member and the inner member i.e., the length of the tube portion therebetween, has to be adjusted relatively precisely to the anatomy of the patient, and is fixed after adjustment. If the distance is set too small, a relatively large pressure is exerted on the skin and inner lumen wall. This may lead to irritation or even damaged tissue in this area. On the other hand, if the distance is set too large, there is a risk of leakage at the stoma. Therefore, the application of such catheters generally relies on the experience of a health care professional.
  • an inflatable balloon may be used instead of, e.g., a plate as inner member.
  • US 5,860,952 A describes a corporeal access tube assembly and method with a balloon. In many cases, variations of the anatomy of different patients can be compensated by inflating such a balloon. However, balloon catheters generally need to be checked for leak-tightness regularly, what might again be too difficult for the patient.
  • the tube comprises a stretchable section that can be arranged to be (or is arranged) between the outer member and the inner member, the stretchable section being stretchable in length, wherein a retaining structure is provided limiting the length, e.g., defining a maximum length, of the stretchable section.
  • the catheter tube is allowed to stretch (at the stretchable section) for a specific length (i.e. , until the maximum length), defined by the retaining structure, with relatively low force and without a risk of breaking.
  • Exceeding the length limitation activates the retaining structure thus preventing additional elongation (and a possible breakage). This does not require additional steps performed by the user. Too long elongation by the user, e.g., during placement, will be prevented by the retaining structure.
  • the catheter offers a wide window in which the user can fix the catheter length without a negative impact on the tissue and use of the catheter. This allows an intuitive placement and adjustment of the catheter. Thus, the usability of the catheter can be strongly improved.
  • the comfort for a patient might be increased, because after being successfully placed, the catheter tube with its stretchable section, can be suitable to compensate for patients movements.
  • the stretchable section may connect a first adjacent section with a second adjacent section of the catheter, particularly in a fluid-tight manner. That is, the stretchable section may be arranged between two other portions of the catheter. This allows a simple manufacturing of the catheter.
  • the stretchable section may fully encompass a section of a duct defined by the tube.
  • the stretchable section and one or both of the adjacent sections may be formed in one piece.
  • the stretchable section is fixedly connected with both of the adjacent sections.
  • the retaining structure may connect the first adjacent section with the second adjacent section. This allows a simple construction.
  • the retaining structure is fixedly connected with both of the adjacent sections.
  • the retaining structure and one or both of the adjacent sections may be formed in one piece.
  • the retaining structure may fully encompass a section of a duct defined by the tube.
  • first adjacent section is a part of the tube and/or the second adjacent section is a part of the tube or the second adjacent section is a section of the inner member.
  • the inner member may be a plate.
  • the material of the stretchable section has a larger elasticity than the material of the adjacent sections.
  • the material of the stretchable section may have a larger elastic modulus, e.g., Young’s modulus, than the material of the adjacent sections.
  • the material of the stretchable section may have a larger elasticity than the material of the retaining structure.
  • the material of the stretchable section may have a larger elastic modulus, e.g., Young’s modulus, than the material of the retaining structure.
  • the stretchable section may have a smaller thickness than the adjacent sections and/or than the retaining structure.
  • the stretchable section and one or both of the adjacent sections may be made of the same type of material, e.g., a polyurethane (Pll), particularly a thermoplastic polyurethane (TPU), or a silicone, or of the same material, e.g., the same Pll, TPU or silicone. In that way the manufacturing can be simplified.
  • the retaining structure may be made of the same type of material, e.g., a polyurethane (PU), particularly a thermoplastic polyurethane (TPU), or a silicone, or of the same material, e.g., the same PU, TPU or silicone and/or have a larger thickness than the stretchable section and/or the adjacent sections.
  • PU polyurethane
  • TPU thermoplastic polyurethane
  • silicone silicone
  • the manufacturing can be further simplified.
  • the retaining structure is bent, alternating or wavy or has a spiral form when no external force is applied on the stretchable section and/or straightened when the stretchable section is stretched. This allows to use thin materials with high tensile stiffness for the retaining structure which do not interfere with the inner duct of the tube or with outer tissue.
  • the retaining structure may be arranged inside an inner volume of the tube, so that it does not contact tissue outside of the tube. Alternatively, it is arranged at an outside of the tube (and/or of the stretchable section).
  • the retaining structure is surrounded by the stretchable section at least along a part of its length.
  • the retaining structure connects both adjacent sections in a fluid-tight manner. This allows to ensure the function of the catheter even if the stretchable section is damaged.
  • the retaining structure may be embedded in material of the stretchable section.
  • the retaining structure may be surrounded by and/or in contact with material of the stretchable section over the majority or all of its (inner and outer) surface. This allows to avoid contact of the retaining structure with tissue and contents of the inner volume of the tube.
  • the stretchable section can have an inner wall surrounded by an outer wall of the stretchable section, together defining a chamber therebetween.
  • the retaining structure is arranged in the chamber. This also allows to avoid contact of the retaining structure with tissue and contents of the inner volume of the tube.
  • the chamber may be annular.
  • the inner member e.g., plate
  • the outer member may comprise a plate with a guide for the tube and a lock movably mounted on the plate for selectively locking the tube with respect to the plate.
  • the stretchable section and the retaining structure together form a polymer nanocomposite having switchable mechanical properties and comprising the stretchable section in the form of a matrix polymer and the retaining structure in the form of a nanoparticle network, wherein the nanoparticle network is formed by a formation of a substantially three-dimensional network of nanoparticles which are incorporated in the matrix polymer and interact with each other and/or with the matrix polymer, wherein the polymer nanocomposite in a first switching state comprises a first stiffness characterized by a first tensile storage modulus, e.g., greater than 6 GPa, in a second switching state comprises a second stiffness characterized by a second tensile storage modulus, e.g., of less than 1 GPa, and is switchable between the first switching state and the second switching state by exposing the polymer nanocomposite to a stimulus that influences interactions among the nanoparticles and/or between the nanoparticles and the matrix polymer.
  • the stimulus may be for example
  • Fig. 1 shows a schematic view of a patient, a catheter for percutaneous feeding being placed on the patient;
  • Fig. 2 shows a schematic view of the catheter of Fig. 1 ;
  • Figs. 3A and 3B show schematic views of the catheter of Fig. 1 during adjustment on the patient;
  • Figs. 4 to 7 show schematic views of various embodiments of the catheter of
  • Figs. 8A and 8B show details of a polymer nanocomposite.
  • Fig. 1 shows a general scenario of a patient P being subjected to a gastro-intestinal feeding.
  • a PEG catheter 1 is placed on the patient P, entering into the patient P through a stoma S.
  • a container 2 encloses food and/or medicine for administration to the patient P and is in fluid connection with a tube 10 of the catheter 1.
  • Fig. 2 shows the catheter 1 in more detail.
  • the catheter 1 comprises a tube 10 having an opening 105 to be arranged in the stomach of the patient P. At the other end, a lid allows to close the tube.
  • an inner member 12 in the shape of an inner plate is fixedly connected with the tube 10.
  • the inner member 12 is circular in this example.
  • the inner member 12 is adapted to rest against an inner gastric wall of the patient P to protect the catheter 1 against accidental removal.
  • the catheter 1 comprises an outer member
  • the outer member 11 comprises a plate 110 with a guide 111 for the tube 10. Further, the outer member 11 comprises a lock 112. In an unlocked state of the lock 112 the tube 10 can be displaced with respect to the plate 110, guided by the guide 111. When the lock 112 is in a locked state, the tube 10 is fixed relative to the plate 110. By this, the correct position of the outer member 11 on the tube 10 may be adjusted. This procedure will now be described with reference to Figs. 3A and 3B.
  • the tube 10 has been arranged to extend through a stoma S into the stomach M of the patient P.
  • the outer member 11 is placed on the skin A of the outer abdominal wall.
  • the tube 10 is received in the guide 111 of the outer member 11 .
  • the lock 112 is open, so the user can adjust the distance d between the outer member 11 and the inner member 12.
  • Fig. 3B illustrates the adjusted state of the catheter 1.
  • the lock 112 is in the locked state and fixes the position of the outer member 11 on the tube 10.
  • the catheter 1 is secured to the patient P in order to avoid, for example, an accidental removal or displacement of the catheter 1.
  • the inner member 12 rests against the inner gastric wall G in the stomach M.
  • a small force is applied on the gastric wall G and skin A to ensure a secure fit and to prevent liquids from entering the Stoma S outside the tube 10. This force is, however, small enough to avoid an irritation or even damage of the abdominal wall.
  • a retaining structure 13A-13D is provided limiting the length (more specifically, defining a maximum length) of the stretchable section 100A-100D, as will be described with reference to Figs. 4 to 7 below.
  • Fig. 4 shows the end part of the tube 10 with the opening 105. At or close to the end opening
  • the stretchable section 100A is located between a first adjacent section 101 and a second adjacent section 102 of the tube 10.
  • the first adjacent section 101 corresponds to the part of the tube 10 from the stretchable section 100A until the outer end of the tube 10.
  • the second adjacent section 102 corresponds to the part of the tube 10 from the stretchable section 100A until the inner end (with the opening 105 and the inner member 12) of the tube 10.
  • the length of the second adjacent section 102 is such that the stretchable section 100A is arranged in the stoma S in an applied state of the catheter 1 .
  • the second adjacent section 102 may be very short.
  • the inner member 12 may optionally serve as the second adjacent section or part.
  • the stretchable section 100A of Fig. 4 has (at least substantially) the same cross section as the adjacent sections 101 , 102.
  • the stretchable section 100A has the (at least substantially) same inner diameter, outer diameter and wall thickness as the adjacent sections 101 , 102.
  • the stretchable section 100A has a smaller modulus of elasticity in tension than the adjacent sections 101 , 102, e.g., the modulus of elasticity of the stretchable section 100A may amount to 60% or less, 50% or less, or 40% or less, of the modulus of elasticity of the adjacent portions 101 , 102.
  • the stretchable section 100A of this example is made of a different, softer, material than the adjacent sections.
  • the material of the stretchable section 100A may be structurally weakened.
  • the same tensile force leads to a substantially larger prolongation (with respect to the same initial lengths) of the stretchable section 100A compared to the adjacent portions 101 , 102, e.g., by a factor of 2, by a factor of 3, by a factor of 4 or even more.
  • the stretchable section 100A can be stretched in length with little forces.
  • the stretchable section 100A may create a nearly constant minimal force between the outer member 11 and the inner member 12. This allows the user a wide range of possible adequate positions of the outer member 11 along the tube 10.
  • the tube 10 is provided with a retaining structure 13A.
  • the retaining structure 13A is arranged inside the tube 10. It has a smaller outer diameter than the stretchable section 100A and the adjacent sections 101 , 102.
  • the retaining structure 13A describes a duct.
  • the retaining structure 13A has a larger wall thickness than the stretchable section 100A, but alternatively it can also have the same or even a smaller wall thickness.
  • the retaining structure 13A has the same wall thickness as the first and/or second adjacent sections 101 , 102. Along the length of its duct, the retaining structure 13A is centrally bent inwards.
  • the stretchable section 100A is made of the same material as the adjacent sections 101 , 102.
  • the retaining structure 13A is fixed to the first adjacent section 101 with one end and fixed to the second adjacent section 102 with the opposing end, e.g., with an adhesive bond.
  • the first and second adjacent sections 101 , 102 and the retaining structure 13A are made in one piece.
  • the retaining structure 13A when a tensile force stretches the stretchable section 100A, the retaining structure 13A is straightened. As soon as it is straight, it effectively blocks a further stretching. Thereby, the retaining structure 13A defines a maximum length of the stretchable section
  • a stretchable section 100B and a retaining structure 13B is embedded into the material of the stretchable section 100B.
  • the stretchable section 100B is made of a material with a smaller modulus of elasticity in tension than the adjacent sections 101 , 102 and/or weakened. It has the same material thickness as the adjacent sections 101 , 102.
  • the retaining structure 13B has the shape of a hose and has a high strength against tensile forces.
  • the retaining structure 13B comprises a metal, such as iron or titan.
  • the retaining structure 13B may be made of a foil and/or of steel.
  • the retaining structure 13B may comprise wires.
  • the retaining structure 13B In a state without external forces acting on the catheter 1 , the retaining structure 13B has a wavy form. Thus, stretching the stretchable section 100B straightens the retaining structure 13B. As soon as the retaining structure 13B is straight, it blocks against a further stretching of the stretchable section
  • the stretchable section 100C comprises an inner wall 103 which is surrounded by an outer wall 104. Between the inner wall 103 and the outer wall 104, a chamber C is formed.
  • the chamber C has an annual shape.
  • the chamber C may be filled with a fluid, e.g., with air.
  • Inside the chamber C the retaining structure 13C is arranged.
  • the retaining structure 13C is configured as the retaining structure 13B of Fig. 5 with the difference that it is not embedded in the material of the stretchable section 100C.
  • each of the inner and outer walls 103, 104 of the stretchable section 100C has a (much) smaller wall thickness compared to the adjacent sections 101 , 102. Therefore, the stretchable section 100C may even be made of the same material as the adjacent sections 101 , 102.
  • the stretchable section 100D also has a thinner wall thickness than the adjacent sections 101 , 102. It is made of a softer material than the adjacent sections 101 , 102.
  • the materials of the stretchable section 100D and of the adjacent sections may be different, but belonging to the same group of materials, e.g., Pll, TPU or silicone. This allows to easily fix these sections to one another.
  • the retaining structure 13D (and this may also be provided for the other examples described above).
  • the retaining structure is configured as in Fig. 6, with the difference that it is not arranged inside a chamber between two walls but forms an inner surface of the duct of the tube 10.
  • a polymer nanocomposite 14 comprises a matrix polymer 140.
  • the matrix polymer 140 in a preferred embodiment, comprises a - preferably highly - polar polymer capable of forming non-covalent interactions, in particular hydrogen bonds, with the nanoparticles.
  • the matrix polymer 140 is PVOH.
  • the polymer nanocomposite 14 further comprises a nanoparticle, particularly a nanofiber network formed by a substantially three-dimensional network of nanofibers 141 , in the particular embodiment described herein tunicate nanowhiskers (TNWs) or cotton nanowhiskers (CNWs).
  • the matrix polymer comprises crystalline regions 142 and amorphous regions 143.
  • the matrix polymer 140 in this case PVOH, is capable of forming hydrogen bonds with the nanofibers 141 (cellulose nanowhiskers NWs, in this case tunicate nanowhiskers TNWs or cotton nanowhiskers CNWs).
  • the tube 10 in accordance with any embodiment described herein may comprise (or consist of) the polymer nanocomposite 14.
  • one or both of the adjacent sections 101 , 102 may be formed by the polymer nanocomposite 14.
  • the stretchable section 100A-100D may be formed by the polymer nanocomposite 14.
  • the retaining structure 13A-13D may be formed by the polymer nanocomposite 14.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Materials For Medical Uses (AREA)

Abstract

Cathéter (1) pour l'alimentation percutanée comprenant un tube (10) pour s'étendre à travers une stomie (S) d'un patient (P) ; un élément externe (11) fixé ou pouvant être fixé sur le tube (10) pour reposer contre la peau (A) du patient (P) ; et un élément interne (12) fixé ou pouvant être fixé sur le tube (10) pour reposer contre une paroi de lumière (G) du patient interne (P). Il est prévu que le tube (10) comprenne une section étirable (100A-100D) pouvant être disposée entre l'élément externe (11) et l'élément interne (12) étirable en longueur, une structure de retenue (13A-13D) étant prévue pour limiter la longueur de la section étirable (100A-100D).
EP22773152.8A 2021-09-07 2022-09-01 Cathéter pour alimentation percutanée Pending EP4398861A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP21195320 2021-09-07
PCT/EP2022/074328 WO2023036682A1 (fr) 2021-09-07 2022-09-01 Cathéter pour alimentation percutanée

Publications (1)

Publication Number Publication Date
EP4398861A1 true EP4398861A1 (fr) 2024-07-17

Family

ID=77666250

Family Applications (1)

Application Number Title Priority Date Filing Date
EP22773152.8A Pending EP4398861A1 (fr) 2021-09-07 2022-09-01 Cathéter pour alimentation percutanée

Country Status (2)

Country Link
EP (1) EP4398861A1 (fr)
WO (1) WO2023036682A1 (fr)

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8500364D0 (en) * 1985-01-08 1985-02-13 Haberman M N Self-sealing catheter
US4861334A (en) * 1988-06-24 1989-08-29 Nawaz Arain Self-retaining gastrostomy tube
DE4236210C1 (de) * 1992-10-27 1994-04-14 Olympus Optical Europ Schlauchförmiges Implantat zur Verwendung bei der perkutanen Nahrungszufuhr
US5860952A (en) 1996-01-11 1999-01-19 C. R. Bard, Inc. Corporeal access tube assembly and method
WO2014040885A2 (fr) 2012-09-14 2014-03-20 Fresenius Kabi Deutschland Gmbh Nanocomposite de polymère ayant des propriétés mécaniques commutables
WO2014040886A1 (fr) 2012-09-14 2014-03-20 Fresenius Kabi Deutschland Gmbh Dispositif d'injection médical
WO2016103268A1 (fr) 2014-12-23 2016-06-30 Fidmi Medical Ltd. Dispositifs et procédés pour gastronomie endoscopique percutanée et autres interventions de stomie

Also Published As

Publication number Publication date
WO2023036682A1 (fr) 2023-03-16

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