EP0288539A1 - Catheter et procede pour l'aspiration, la perfusion et la stimulation intestinales et utilisation dudit catheter dans le diagnostic de maladies/allergies intestinales - Google Patents

Catheter et procede pour l'aspiration, la perfusion et la stimulation intestinales et utilisation dudit catheter dans le diagnostic de maladies/allergies intestinales

Info

Publication number
EP0288539A1
EP0288539A1 EP19870907542 EP87907542A EP0288539A1 EP 0288539 A1 EP0288539 A1 EP 0288539A1 EP 19870907542 EP19870907542 EP 19870907542 EP 87907542 A EP87907542 A EP 87907542A EP 0288539 A1 EP0288539 A1 EP 0288539A1
Authority
EP
European Patent Office
Prior art keywords
catheter
intestinal
segment
intestine
lumens
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.)
Withdrawn
Application number
EP19870907542
Other languages
German (de)
English (en)
Inventor
designation of the inventor has not yet been filed The
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.)
Pfizer Health AB
Original Assignee
Pharmacia AB
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 Pharmacia AB filed Critical Pharmacia AB
Publication of EP0288539A1 publication Critical patent/EP0288539A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02—Instruments for taking cell samples or for biopsy
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/0105—Steering means as part of the catheter or advancing means; Markers for positioning
    • A61M25/0108—Steering means as part of the catheter or advancing means; Markers for positioning using radio-opaque or ultrasound markers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1011—Multiple balloon catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1052—Balloon catheters with special features or adapted for special applications for temporarily occluding a vessel for isolating a sector

Definitions

  • This invention relates generally to catheters and more particularly to a catheter for intestinal aspiration, perfusion and provocation of a segment of the intestine, and also to a novel method in which the catheter is used for the diagnosis of intestinal diseases/allergy, based on assays of aspirated cells, mucus and intestinal fluid with and without a provocation method.
  • the catheter according to the invention is constructed in such a way that it combines minimal discomfort and minimal risk for the patient, with high frequency of successful insertions, quantitative yield and improved sensi ⁇ tivity in the diagnostic procedure.
  • the diagnostic methods which are available today for the investigation of suspected intestinal diseases are non ⁇ specific and not very sensitive.
  • An example of a situation where improved diagnostic performance would be desirable is for the investigation of abdominal symptoms related to intolerance to foodstuffs.
  • a method to characterize the importance of the intestine for allergic manifestations in other organs e.g. in the air ways (asthma, rhinitis) or in the skin (eczema, dermatitis herpetiformis, urticaria and other skin diseases of allergic genesis).
  • inflammatory processes in the small intestine could be of importance for the development and clinical outcome in some rheumatic joint diseases.
  • Salazopyrin E ⁇ a drug mainly used in the treatment of chronic inflammatory bowel diseases, (Crohn's disease and ulcerative colitis), emphasizes the importance of the intestine for the development of joint diseases. Many patients with inflammatory bowel disease will be subject to surgery several times during their lifetime. The routine methods available today for assessing inflammatory changes in the small intestine are unsatisfactory. Thus, there is a great need for improved diagnostic procedures to decide when surgical treatment is necessary. Celiac disease (hyper- sensitivity to gluten) is a relatively common disease in the intestine. It is, however, not uncommon that the final diagnosis is delayed.
  • the immune system of the intestine is quantitatively the largest immunological component in the human body and there is an increasing interest to characterize its role in different diseases. Thus, there is a growing need for methods enabling direct studies of the local immune system in the small bowel.
  • Diagnostic methods available at present for investigations of the above mentioned diseases comprise X-ray examinations (with or without the use of contrast medium), biopsy of the small intestine with histopathological evaluation, chemical analysis- of faeces (excrement), faecal cultures and microscopic assay of faeces.
  • exclusion diet which often means spending weeks in hospital.
  • the patient is initially on a basic diet and different foodstuff components are supplemented in a stepwise fashion until a clinical reaction occurs.
  • US-4 368 739 relates to a catheter intended for the smal l intestine, but this catheter is inserted in connection with surgery, when the patient is under anaesthes ia and the abdominal wall is opened. Moreover, the inflated balloons are only Intended for moving the catheter in the intestine by ways of manipulation. Thus , it cannot be used to establish a 'physiological' segment.
  • one object of the present invention is to provide a catheter for advanced diagnostic purposes which can be successfully inserted into the small intestine (jejunum/ileum) of unanaesthetized patients with a minimum of risk or discomfort.
  • Another object of the present invention is to provide a method for diagnosing and characterizing diseases particularly in the small intestine. This method also provides the opportunity to study the response of the intestine to different types of provocations, performed locally in a chosen segment of the intestine. The method can be used as an out-patient procedure. Analyses of one or more of the components of the intestinal content such as cells, mucus and fluid will probably generate novel and important information about the physiology and pathophysiology of the intestine.
  • a catheter according to the invention satisfies the following crucial requirements: a) the patient is submitted to a minimum of discomfort, b) the catheter is designed according to anatomical principles in order to minimize the risk for the pat ient . Thu s , there i s no ri sk of p enetration o f the intestinal wall. Also, the test s egment can be shut off securely between the two balloons, preventing exposure outside the test segment. Moreover, the insertion procedure with the catheter is rapid, to minimize radiation exposure from X-ray, c) there are separate lumens for in- and outflow of perfusion fluid, so that contamination is avoided and a continuous perfusion generating quantitative information is guaranteed.
  • the patient Due to the construction of the catheter, the patient is exposed to a minimal risk during - allergen provocation because the method invo lves 1 ) low concentrations of allergen, 2 ) local exposure of only a few percent of the whole small intestine and 3 ) only for a short time (the provocation fluid can be evacuated at any time) .
  • the idea behind the present invention is thus to offer a c athete r sy s tem and a method fo r d iagnos is o f d i s ease processes in the small intestine.
  • the catheter system requires :
  • this intestinal segment can be isolated from the rest of the intestine between two inflatable balloons.
  • the number of different lumens must be such that it is pos s ible to continuous ly guarantee, with the aid of several marker substances, that there is no contamination worth mentioning from the intestinal portions outside the segment.
  • a perfusion system of the above type which is practical and clinically useful, and which, as far as can be foreseen, fulfils the safety requirements for the patient during the investigation, is obtained with a catheter and a method according to the characterizing part of claim 1 and claim 8, respectively.
  • Fig. 1 is a schematic view of the catheter according to the present invention
  • Fig. 2 is a cross-sectional view of the catheter
  • Fig. 3 shows the position of the catheter when it has been brought into position in the small intestine, and also a small catheter for draining the stomach, and
  • Fig. 4 is a schematic view of the proximal end of the catheter.
  • Fig. 1 shows a catheter (1) mainly comprising a tube (2) of PVC, alternatively polyurethane or a similar material, having a length of 175-550 cm.
  • a typical catheter for jejunum is 175-180 cm in length and has a diameter of 4-7 mm.
  • a typical jejunal catheter for adults has a diameter between 4,5 and 5,5 mm.
  • the cross-section of the tube is seen in Fig. 2. It has two larger central lumens (3 and 4) extending in parallel and occupying a major part of the volume of the tube. In the perifery of the catheter there are four smaller lumens (5, 6, 7 and 8).
  • a tube of this kind can be produced by injection moulding in a manner known per se.
  • On the tube there are at least two inflatable balloons (9 and 10) preferably of silicon, latex or polyurethane. These balloons are spaced from each other with an internal distance of approx. 10 cm. This distance has been found to give an optimal intestinal surface for the perfusion. A longer distance between the balloons has been found to impede drainage from the segment because some of the holes in the segment therebetween will be 'plugged' by the intestinal wall.
  • the pressure in the balloons should be well under the normal diastolic blood pressure (70-80 mm Hg) to avoid pressure damages on the intestinal wall.
  • the catheter With a balloon pressure as low as used in the present invention, the catheter can be in its position for several days without risking any damage on the intestinal wall of the patient. Filled with approx. 40 ml air the balloons will obtain a diameter of 3-4 cm.
  • the distal balloon (9) is placed at a distance not less than 10 cm from the tip of the catheter, because otherwise the tip will not be sufficiently flexible, and this in turn will make the insertion . of the catheter more difficult.
  • a stiffening metal wire (12) is located in one of the central lumens (4).
  • the wire is preferrably coated with a plastics material, e.g. Teflon*.
  • Teflon* a plastics material
  • This wire is used during the insertion (see Fig. 3) to give the catheter increased rigidity. This enables easier insertion of the catheter through the stomach and past the pylorus (13). After passing the pylorus the wire is pulled back a little bit making the tip (11) of the catheter easily flexible again so that it can follow the contour of the intestine.
  • the wire can be completely pulled out; the catheter "migrates by itself” due to the contractions of the intestine.
  • the tip (11) of the catheter there are 15-20 cylindrical weights (14) of e.g. tungsten with a diameter of 3 mm and a length of 5 mm. 15 mm from the tip of the catheter there is a plastic plug (16) separating the three most distally positioned tungsten weights.
  • a physiological perfusion fluid is added to the closed space (segment) between the balloons through one of the larger central lumens (3).
  • the fluid enters the segment through a centrally located hole (17) and is drained through the other central lumen (4) through several holes (18) placed over the whole length of the segment.
  • the use of different lumens for in- and outflow of the perfusion fluid guarantees that there is no contamination in the lumens.
  • One of the central lumens (3) is closed with a plastic plug (15) distally of the hole (17), to avoid a 'sump effect' in the tip.
  • the other central lumen (4) extends all the way to the weight (14), enabling the wire (12) to be inserted as far distally as possible.
  • the lumens (6 and 7) are intended for air supply for the purpose of inflating the balloons (9 ' and 10).
  • the lumens (5 and 8) are used for marker solutions, different for different groups of patients. The solutions can be directed out of the catheter through the holes (19 and 20) on each side of the segment. This is extremely important to guarantee that no leakage worth mentioning occurs past the balloons.
  • lumens (5 and 8) and holes (19 and 20) can be used for drainage.
  • the jejunal catheter according to the invention can be formed with several lumens and balloons. Thereby several separate segments of the intestine can be provided simultaneously for very sofisticated studies of processes in the intestine.
  • Fig. 4 shows that the proximal connections for the lumens are provided with self-sealing connections (22) for instance of Luer-type and with pressure balloons (23) for the lumens leading to the inflatable bal loons . Also , it is pos sible to provide the air lumens with a pressure guard system for registration of the pressure in the balloons.
  • the catheter is inserted through the patients mouth, which can be done with the patient unanaesthetized (in some cases light spraying of the pharynx with a local anaesthetic will be necessary or at least make the insertion more comfortable). Thanks to the small diameter of the catheter it is very easy to insert (swallow) the catheter through the oesephagus and down into the stomach; this is preferably done by the patient himself/herself.
  • the wire positioned in the catheter gives the catheter such a rigidity, and the tungsten plates give the tip such a weight, that it is very easy to insert the catheter through the stomach and past the pylorus into the intestine.
  • the catheter When the catheter has been brought into the desired position in the small intestine this is controlled by X-ray. Thereafter the upper balloon is inflated and the downstream portion of the intestine is perfused a while to irrigate intestinal content e.g. food, bile or pancreatic enzymes out of the intended portion for the segment. This balloon will also block the entry of bile and pancreatic enzymes into the perfusion segment. Thereafter the lower balloon is inflated so that a delimited and biologically closed space is obtained. As used here, biologically closed of course does not mean that the space is hermetically sealed, this only involves a geometric delimitation of a segment of the intestine under physiological conditions.
  • the segmental perfusion according to the invention offers a method for extremely sensitive and specific biological assays of the intestinal content. Also, it enables that e.g. drugs which can be dangerous when the whole surface of the intestine is exposed can be added locally in the intestine. This also enables that the perfusion fluid can be provided with components or substances which protect cells, mucus or biological subs tances from being destroyed or inactivated. This will increase the yield of the analytes and the accuracy of the analys is .
  • This physiologically clos ed segment also enables a system which is simpler and safer for the patient and which will ' improve diagnostic possibilities as exemplified by the following diagnostic procedures:
  • the component suspected to cause the allergic reaction is introduced in different concentrations (provocation) into the closed and perfused segment of the small intestine.
  • provocation When the component has been in contact with the small intestine for a predetermined time the segment is irrigated through lumens 3 and 4.
  • the irrigation fluid is thereafter analysed with respect to its contents of substances , which in case of allergic-inflammatory response from the cells of the small intestine exist in increased concentrations in the irrigation fluid.
  • the procedure involves : a/ time limited exposure of allergen, b/ local exposure of al lergen to a very small part of the intestine, c/ increased sensitivity in the assay systems of the perfusion liquid, and d/ lower concentrations of allergen.
  • a positive response of such a provocation is local and asymptomatic contrary to the pres ently avai lab le method which entai ls general exposure of the intestine and is intended to provoke symptoms.
  • the method according to the pres ent invention provides reproducible results at very low allergen concentrations .
  • a 1000- 10000 fold dilution of the normally exi sting dose of allergen In e. g. foodstuff gives a reliable response of the sma ll intestine.
  • An example of a substance which we have analysed after provocation with an allergen is histamine.
  • An increase in histamine concentration in the irrigation fluid is an apparent feature in cases of provocation with subs tances against which the patient is allergic.
  • Hyaluronan is another interesting analyte. Specific antibodies may be investigated.
  • the marker solutions can contain either colouring agents or radioactive markers. In case of radioactive markers they could be attached to large sugar molecules, which makes it impossible for the human body to absorbe them.
  • the aforementioned objects have been obtained with the present invention. Thanks to the construction of the catheter according to the present invention it can be inserted with a minimum of discomfort for the patient.
  • the insertion of the catheter is performed through the mouth and can be done by the patient himself/herself.
  • the catheter is constructed in such a way that the risks connected with catheters according to prior art are essentially avoided.
  • the catheter according to the present invention is stable and soft, so that the intestinal wall of the patient will not be damaged, but not so soft that it bends. Thanks to the unique channel system of the catheter it can be guaranteed that perfusion fluid does not leak outside the specific delimited intestinal segment or that the perfusion fluid is contaminated with intestinal contents from outside the perfused segment.
  • the X-ray dosis the patient is exposed to during investigation using the catheter is very low due to the fact that the catheter according to the present invention has such a length and construction that it can be inserted very fast into a desired position in the small intestine.
  • the jejunal catheter according to the invention provides an opportunity for clinical research and routine diagnosis concerning diseases related to the small intestine. This opportunity to accurately diagnose and treat intestinal diseases has not previously existed.
  • Another useful application of the catheter is in the study of gastro-intestinal physiology and pharmacology.
  • quantitative information e.g. regarding flow rates and composition of bile and pancreatic.fluid.
  • quantitative information e.g. regarding dose-response relationship

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Anesthesiology (AREA)
  • Hematology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • External Artificial Organs (AREA)

Abstract

Sont ici décrits un cathéter destiné à l'aspiration, la perfusion et la stimulation intestinales d'un segment ainsi qu'un procédé d'utilisation dudit cathéter à des fins de diagnostic. Ledit cathéter comprend un tube (2) en matériau flexible pourvu d'au moins quatre lumières (3, 4, 5, 6, 7, 8) assurant le transport de fluides d'irrigation, d'air ou d'une solution marqueuse. Ledit tube est en outre pourvu d'orifices (17, 18, 19, 20) qui communiquent avec les lumières et l'espace situé à l'extérieur du cathéter. Celui-ci comprend également au moins deux ballons gonflables (9, 10), grâce auxquels un segment de l'intestin grêle peut être isolé hermétiquement de façon à former un espace de test entre eux. Le cathéter comporte en outre un fil de raidissement (12) et un lest disposé à la pointe (11) du cathéter de façon à en faciliter l'insertion. Ledit cathéter se caractérise par le fait qu'il est conçu de façon à pouvoir être inséré dans l'intestin grêle sans anesthésie et sans acte chirurgical. Ledit procédé se caractérise par sa rapidité et sa sûreté ainsi que par son aptitude à être utilisé pour le diagnostic de maladies intestinales avec une spécificité et une sensibilité qu'il n'a pas été possible d'obtenir auparavant.
EP19870907542 1986-11-11 1987-11-11 Catheter et procede pour l'aspiration, la perfusion et la stimulation intestinales et utilisation dudit catheter dans le diagnostic de maladies/allergies intestinales Withdrawn EP0288539A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SE8604822A SE455368B (sv) 1986-11-11 1986-11-11 Anordning for nedleggning i tunntarmen i och for intestinal aspiration/perfusion
SE8604822 1986-11-11

Publications (1)

Publication Number Publication Date
EP0288539A1 true EP0288539A1 (fr) 1988-11-02

Family

ID=20366253

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19870907542 Withdrawn EP0288539A1 (fr) 1986-11-11 1987-11-11 Catheter et procede pour l'aspiration, la perfusion et la stimulation intestinales et utilisation dudit catheter dans le diagnostic de maladies/allergies intestinales

Country Status (5)

Country Link
EP (1) EP0288539A1 (fr)
JP (1) JPH01502484A (fr)
AU (1) AU8271387A (fr)
SE (1) SE455368B (fr)
WO (1) WO1988003389A1 (fr)

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US7865247B2 (en) 2006-12-18 2011-01-04 Medtronic, Inc. Medical leads with frequency independent magnetic resonance imaging protection
US8768486B2 (en) 2006-12-11 2014-07-01 Medtronic, Inc. Medical leads with frequency independent magnetic resonance imaging protection

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Cited By (2)

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Publication number Priority date Publication date Assignee Title
US8768486B2 (en) 2006-12-11 2014-07-01 Medtronic, Inc. Medical leads with frequency independent magnetic resonance imaging protection
US7865247B2 (en) 2006-12-18 2011-01-04 Medtronic, Inc. Medical leads with frequency independent magnetic resonance imaging protection

Also Published As

Publication number Publication date
SE455368B (sv) 1988-07-11
SE8604822L (sv) 1988-05-12
SE8604822D0 (sv) 1986-11-11
WO1988003389A1 (fr) 1988-05-19
JPH01502484A (ja) 1989-08-31
AU8271387A (en) 1988-06-01

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