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WO2007126380A1 - Catheter de microdialyse equipe de moyens de fixation - Google Patents

Catheter de microdialyse equipe de moyens de fixation Download PDF

Info

Publication number
WO2007126380A1
WO2007126380A1 PCT/SE2007/050282 SE2007050282W WO2007126380A1 WO 2007126380 A1 WO2007126380 A1 WO 2007126380A1 SE 2007050282 W SE2007050282 W SE 2007050282W WO 2007126380 A1 WO2007126380 A1 WO 2007126380A1
Authority
WO
WIPO (PCT)
Prior art keywords
catheter
outer tube
mounting
suture
distal end
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.)
Ceased
Application number
PCT/SE2007/050282
Other languages
English (en)
Inventor
Stefan Lindgren
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.)
BURMAN SVEN
CMA Microdialysis AB
Original Assignee
BURMAN SVEN
CMA Microdialysis 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
Priority claimed from SE0600972A external-priority patent/SE0600972L/xx
Application filed by BURMAN SVEN, CMA Microdialysis AB filed Critical BURMAN SVEN
Publication of WO2007126380A1 publication Critical patent/WO2007126380A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00—Instruments for taking body samples for diagnostic purposes; Other methods or instruments for diagnosis, e.g. for vaccination diagnosis, sex determination or ovulation-period determination; Throat striking implements
    • A61B10/0045—Devices for taking samples of body liquids
    • A61B2010/008—Interstitial fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/34—Trocars; Puncturing needles
    • A61B2017/348—Means for supporting the trocar against the body or retaining the trocar inside the body
    • A61B2017/3482—Means for supporting the trocar against the body or retaining the trocar inside the body inside
    • A61B2017/3484—Anchoring means, e.g. spreading-out umbrella-like structure
    • A61B2017/3488—Fixation to inner organ or inner body tissue

Definitions

  • the present invention generally relates to a catheter according to the preamble of claim 1 , and especially to a microdialysis catheter, more specifically for use for diagnostic or testing purposes. It may be used in the body or an organ in order to perform various analyses of e.g. interstitial fluids etc. and the catheter may be temporarily fixated in place and thereafter withdrawn.
  • catheter should be interpreted also as probe.
  • Perfusion liquid is the liquid used in the microdialysis, which is allowed to enter the probe and there take up substances from the surrounding tissue through a membrane.
  • the perfusion liquid becomes the dialysate after the dialysis.
  • shaft should be understood as being one or more concentric tubes arranged in the catheter.
  • the inlet and outlet of the catheter as described may in case of a reversed flow be used as outlet and inlet, respectively.
  • Microdialysis is used to monitor interstitial fluids and blood in various body organs.
  • the technique relies on the passage of a perfusion liquid through the catheter and the collection of the resulting dialysate, which is the result of the microdialysis having taken place through the membrane during the passage of the perfusion liquid through the catheter.
  • Microdialysis provides a method for in vivo sampling, during which little or no fluid is removed from or introduced into the system. It involves having the catheter located at a site for measurements, the catheter exhibiting a dialysis membrane at that site, thereafter continuously/discontinuously perfusing the interior of the membrane with a solution similar in composition to the body fluid at that site.
  • the dialysate containing substances which during the dialysis have diffused through the membrane, may easily be collected and analyzed.
  • the perfusion liquid on entering the catheter may also contain substances which are supplied to the body/organ.
  • the substance may e.g. be a pharmaceutical preparation, an isotope, or a substrate for an enzymatic reaction in the liver.
  • Microdialysis probes are by nature fragile and very small, which requires great care in inserting and withdrawing the probe from the tissue in which it is used. Probes are often made in the form of an inner and an outer tube, where the outer tube exhibits a membrane and the dialysate and the perfusate, is entering and exiting the tube at one end, and the other end of the tubes are fused or plugged.
  • the rigid or flexible type cannula probe have, even though their geometries differ, relatively large diameters at the junction of their inlet and outlet tubing since they enter and exit a body at the same point. This type of probe is usually partly entered into brain tissue or some other tissue from the outside of the body, i. e.
  • the liquid cross will be outside the tissue to be measured on, and thus has a limited available depth depending on the length of the probe, where the dialysis is to take place.
  • This design also has limitations in the attachment and insertion of the probe to/in soft and/or moving tissue, e.g. skin, heart, liver, eye, and tumor in that the catheter should be fixated in place. The problem is discussed below in connection with a prior art catheter shown in Fig. 1
  • Fig. 1 is shown a microdialysis catheter according to the prior art.
  • Inlet and outlet ducts for perfusion liquid and dialysate 101 and 102 are shown entering a mounting 103, also described as a liquid cross.
  • the mounting exhibits a grove 108, which is intended to use in combination with a suture 109 in order to fixate the catheter in the tissue of organ.
  • the catheter further comprises an inner tube 104 arranged to reach essentially to the distal end 107 of the catheter. Concentrically with the inner tube
  • outer tube 105 having a dialysis membrane 106, the membrane is preferably placed adjacent to the distal end 107 of the catheter.
  • the dialysis membrane is fastened to the outer tube
  • the suture 109 fixated in the grove 108 is used to fasten the suture in a suitable ligament or the like.
  • the suture is preferably of a reabsorb- able type. The man skilled in the art would know how to perform this.
  • the catheter may then by pulling be loosened from the ligament and the withdrawal may be started.
  • withdrawal has two moments which still present a problem, one when the liquid cross is withdrawn and the other is that the withdrawal itself puts compressive forces from tissue and tensile forces from pulling, etc. on the liquid-containing parts of the catheter i.e. the outer tube 105 and the inner tube 104. These forces are concentrated to the outer tube 105 and may propagate to the glued joint between the outer tube 105 and the membrane 106 and damage the same.
  • microdialysis probes are described in SE-C-434 214, US,A,5,735,832 and US,A,5,741,284. Further patents representing various devices for microdialysis are e.g. US 4,694832, US 5,106365, and US 6929618.
  • the invention relates to a catheter adapted to be attached to organs or tissue, said catheter having an inlet and an outlet for perfusion liquid and dialysate, respectively, which at the proximal end of the catheter are joined in a mounting, an inner tube and a concentrically arranged outer tube operatively coupled to the mounting, said inner tube and outer tube extending to the distal end of the catheter, said outer tube having a membrane arranged in surface of the outer tube adjacent to the distal end of the catheter said catheter further having an outer shaft arranged concentrically with the outer tube, and means for fixation of the catheter comprising at least one suture attached to the mounting, so as to pass between outer tube and the outer shaft.
  • the mounting of the catheter according of the invention is the liquid cross.
  • the mounting exhibits fastening means for attaching the at least one suture to the same.
  • the outer shaft adjacent its distal end comprises fixating means for fixating the suture to the distal end of the outer shaft.
  • microdialysis probe which is may be inserted both into more deeply located organs or in generally deeply located places for microdialysis, where the common type of catheter will be difficult to attach and remain attached during the microdialysis procedure.
  • the catheter should then so constructed as to allow complete removal with ease.
  • To be able to leave the microdialysis catheter in the liver after operation allows for early detection of complications in the transplant and will allow the surgeon to re-operate and thus increases the chance to save the liver from complications such as thrombosis, cholangitis etc.
  • the catheter may just as well be used before removal of the liver from the donator and also while waiting for the transplantation.
  • the catheter may of course also be used in any other appropriate location as the liver is only used for exemplary purposes in this description.
  • the catheter should thus be removable fastened to the organ or tissue in which the catheter is placed.
  • the catheter according to the invention is therefore supplied with a suture which is used for suturing the catheter to e.g. the falciform ligament at the liver.
  • the invention is described as having one suture, however, the catheter could be provided with more than one suture.
  • a problem is how to attach the suture to the catheter safely.
  • the suture needs to be attached such that there is no risk of leaving any part of the catheter in the wound
  • the mounting exhibits fastening means for attaching the at least one suture (209;309;409) to the same.
  • the outer shaft adjacent its distal end comprises fixating means for fixating the suture to the distal end of the outer shaft.
  • a gold thread is arranged within the inner tube (204;304;404) at the distal end (207; 307; 407) of the inner tube in order to make the catheter observable using X-ray etc.
  • Fig. 1 shows a catheter according to prior art
  • Fig. 2 shows a first embodiment of the catheter according to the invention.
  • Fig. 3 shows a second embodiment of the catheter according to the invention.
  • Fig. 4 shows a third embodiment of the catheter according to the invention.
  • FIG. 2 is shown a microdialysis catheter according to one embodiment of the invention.
  • Inlet and outlet ducts for perfusion liquid and dialysate 201 and 202 are shown entering a mounting 203, which may be identical to that which is termed a liquid cross.
  • the catheter further comprises an inner tube 204 arranged to reach essentially to the distal end 207 of the catheter. Concentrically with the inner tube 204 and outside the same an outer tube 205 is arranged.
  • the outer tube 205 having a dialysis membrane 206, and the membrane is preferably placed adjacent to the distal end 207 of the catheter.
  • Indicated at the 211 is the abdominal wall through which the liquid bearing parts at a later stage will have to be withdrawn through. It should be noted that in this embodiment the liquid cross 203 will remain outside the abdominal wall 211 making for an easier removal of the catheter.
  • a suture 209 is used also here in order to fixate the catheter in the measurement location.
  • the suture is not fastened into a circumferential grove in the liquid cross as in the known art but fasten/fixated 208 in the liquid cross in such a manner that it will be protected. The withdrawal will thus not put the same compressive forces from tissue and tensile forces from pulling, etc. on the liquid-containing parts of the catheter i.e. the outer tube 205 and the inner tube 204.
  • This is avoided according to the invention by arranging an outer shaft 210 concentrically with, and outside the outer tube 205.
  • the suture 209 is fixated in a fastening means 208 in the liquid cross/mounting 203 at a location between the outer tube 205 and the outer shaft 210, thereby protecting the outer tube 205, the inner tube 204 and the membrane from tensile and compressive forces as they will be taken up by the outer shaft 210.
  • Exemplary measurements for a microdialysis catheter may be summarized as follows.
  • FIG. 3 and 4 Further embodiments according to the invention are shown in Fig. 3 and 4 in which the catheter essentially only differs in how the suture is fixed to the catheter. Like reference numbers in Fig. 2, Fig. 3, and Fig. 4 denote the same details.
  • Fig 3 is shown that the suture which is fixated in the mounting 303 by a fastening means 308 also is fixated at 313 by threading the suture through a hole in the wall of the outer shaft 310 creating a loop in the suture on exiting the interspace between the outer shaft 310 and the outer tube 305. The pulling and tensile forces will then essentially be taken up by the outer shaft while the rest of the catheter is protected.
  • Fig 4 the suture which is fixated in the mounting 403 by a fastening means 408 also is fixated at 413 by a fixating means e.g. application of glue or the like 413 to the outer shaft 410. It is, however, important that the glue does not attach to the outer tube 405 as that would destroy the effect. The pulling forces will then essentially be taken up by the outer shaft while the rest of the catheter is protected.
  • a fixating means e.g. application of glue or the like 413 to the outer shaft 410.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pathology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)

Abstract

La présente invention concerne un cathéter adapté pour être fixé à des organes ou un tissu, ledit cathéter ayant un orifice d'entrée et un orifice de sortie pour un liquide de perfusion et un dialysat, respectivement, lesquels en l'extrémité proximale du cathéter sont réunis dans un montage ; un tube intérieur et un tube extérieur arrangé de manière concentrique couplés de manière fonctionnelle au montage, lesdits tube intérieur et tube extérieur s'étendant vers l'extrémité distale du cathéter, ledit tube intérieur ayant une membrane disposée dans la surface du tube extérieur adjacente à l'extrémité distale du cathéter, ledit cathéter ayant une tige extérieure (210 ; 310 ; 410) arrangée de manière concentrique avec le tube extérieur (205 ; 305 ; 405) et ce moyen de fixation du cathéter comprenant au moins une suture (209 ; 309 ; 409) est fixé au montage (203 ; 303 ; 403), de manière à passer entre le tube extérieur (205 ; 305 ; 405) et la tige extérieure 210; 310; 410).
PCT/SE2007/050282 2006-05-02 2007-04-27 Catheter de microdialyse equipe de moyens de fixation Ceased WO2007126380A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US74617906P 2006-05-02 2006-05-02
SE0600972-4 2006-05-02
US60/746,179 2006-05-02
SE0600972A SE0600972L (fr) 2006-05-02

Publications (1)

Publication Number Publication Date
WO2007126380A1 true WO2007126380A1 (fr) 2007-11-08

Family

ID=38655806

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SE2007/050282 Ceased WO2007126380A1 (fr) 2006-05-02 2007-04-27 Catheter de microdialyse equipe de moyens de fixation

Country Status (1)

Country Link
WO (1) WO2007126380A1 (fr)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100152555A1 (en) * 2008-12-09 2010-06-17 Pernilla Abrahamsson Method and device for microdialysis sampling

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE434214B (sv) * 1982-12-01 1984-07-16 Carl Urban Ungerstedt Dialysprob, avsedd for inforing i biologiska vevnader
US5106365A (en) * 1989-06-16 1992-04-21 Europhor Sa Microdialysis probe
EP0534074A1 (fr) * 1991-09-16 1993-03-31 Institut für Diabetestechnologie gemeinnützige Forschungs- und Entwicklungsgesellschaft mbH Procédé et dispositif pour la mesure de la concentration des éléments constituants dans le fluide du corps
WO1994013195A1 (fr) * 1992-12-15 1994-06-23 Institute Of Neurology Sondes de dialyse
US5735832A (en) * 1994-02-04 1998-04-07 Cma/Microdialysis Holding Ab Reinforced microdialysis probe
US6929618B1 (en) * 1999-07-14 2005-08-16 Cma/Microdialysis Ab Microdialysis probe

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SE434214B (sv) * 1982-12-01 1984-07-16 Carl Urban Ungerstedt Dialysprob, avsedd for inforing i biologiska vevnader
US5106365A (en) * 1989-06-16 1992-04-21 Europhor Sa Microdialysis probe
EP0534074A1 (fr) * 1991-09-16 1993-03-31 Institut für Diabetestechnologie gemeinnützige Forschungs- und Entwicklungsgesellschaft mbH Procédé et dispositif pour la mesure de la concentration des éléments constituants dans le fluide du corps
WO1994013195A1 (fr) * 1992-12-15 1994-06-23 Institute Of Neurology Sondes de dialyse
US5735832A (en) * 1994-02-04 1998-04-07 Cma/Microdialysis Holding Ab Reinforced microdialysis probe
US6929618B1 (en) * 1999-07-14 2005-08-16 Cma/Microdialysis Ab Microdialysis probe

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100152555A1 (en) * 2008-12-09 2010-06-17 Pernilla Abrahamsson Method and device for microdialysis sampling
WO2010068158A1 (fr) * 2008-12-09 2010-06-17 Pernilla Abrahamsson Procede et dispositif d'echantillonnage en microdialyse
US8602990B2 (en) * 2008-12-09 2013-12-10 Md Biomedical Ab Method and device for microdialysis sampling

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