WO2010067062A1 - Cathéters - Google Patents

Cathéters Download PDF

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Publication number
WO2010067062A1
WO2010067062A1 PCT/GB2009/002843 GB2009002843W WO2010067062A1 WO 2010067062 A1 WO2010067062 A1 WO 2010067062A1 GB 2009002843 W GB2009002843 W GB 2009002843W WO 2010067062 A1 WO2010067062 A1 WO 2010067062A1
Authority
WO
WIPO (PCT)
Prior art keywords
tubing
vessel
catheter
helical
flow
Prior art date
Application number
PCT/GB2009/002843
Other languages
English (en)
Inventor
Gianfilippo Coppola
Original Assignee
Imperial Innovations Limited
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 Imperial Innovations Limited filed Critical Imperial Innovations Limited
Publication of WO2010067062A1 publication Critical patent/WO2010067062A1/fr

Links

Classifications

    • 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
    • A61M25/0043—Catheters; Hollow probes characterised by structural features
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M25/003—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves
    • A61M2025/0031—Multi-lumen catheters with stationary elements characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves characterized by lumina for withdrawing or delivering, i.e. used for extracorporeal circuit treatment
    • 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
    • A61M25/0021—Catheters; Hollow probes characterised by the form of the tubing
    • A61M25/0023—Catheters; Hollow probes characterised by the form of the tubing by the form of the lumen, e.g. cross-section, variable diameter
    • A61M25/0026—Multi-lumen catheters with stationary elements
    • A61M2025/0039—Multi-lumen catheters with stationary elements characterized by lumina being arranged coaxially

Definitions

  • the invention relates to catheters.
  • Haemodialysis involves removing blood from the patient, passing it through a dialyser where toxins and water are removed by membrane diffusion, and then returning the processed blood back to the patient.
  • This treatment requires vascular access and a preferred way of achieving such access is to surgically modify the patient's blood vessels to create an arteriovenous fistula. This involves joining an artery and a vein to form the fistula and then waiting a period of time, typically a small number of months, for the fistula to mature. After maturation has taken place, the fistula is available for dialysis and this is accomplished by inserting two needles through the skin and into the fistula, one for withdrawing blood and the other for returning the dialysed blood to the patient.
  • a common form of vascular access involves the use of percutaneous catheter assemblies.
  • a catheter is inserted through the skin and into a major vein, such as the femoral, subclavian or jugular vein.
  • the distal end of the catheter is passed along the vein to a suitable site such as the superior vena cava.
  • the catheter usually is in the form of a single assembly having a suction or aspiration line with an inlet and a return line with an outlet. The assembly is left in the body after its surgical deployment, ready to be used in a haemodialysis session.
  • a problem with the use of percutaneous catheter assemblies is that they are subject to infection and stenosis problems.
  • One response to the stenosis is to remove the catheter assembly and start again. However, at that point the tissue which has formed around the catheter assembly can inhibit removal.
  • a catheter for insertion in a vessel of the human or animal body comprising tubing defining a flow lumen, the tubing having an outer surface portion which extends longitudinally and helically so as to induce swirl flow in a vessel externally of the tubing when in use in the vessel.
  • a catheter When such a catheter is in use in a vessel it can induce or enhance swirling flow in the vessel, externally (shell side) of the tubing, and so inhibit the occurrence of thrombosis. This may be of benefit when the catheter is in place for long periods of time.
  • One use of such a catheter is in a line used for dialysis, for example for end stage renal failure patients in whom it is not feasible to construct arteriovenous fistulae, or for patients awaiting maturation of a fistula.
  • Other illustrations would be in the treatment of patients requiring intravenous drips and patients with temporary renal shutdown.
  • the tubing and the flow lumen defined thereby extend longitudinally and helically.
  • the locus of centroids of the tubing is a line which follows a helical path in the longitudinal direction (the centroid being the centre point of the cross-section of the tubing at any location along its length).
  • This helical path is referred to in this specification as the "helical centreline”.
  • the tubing extending longitudinally and helically in these preferred embodiments, its outer surface forms the outer surface portion which will induce the desired swirl flow.
  • the geometry of the helical centreline may be defined in terms of its amplitude and its helix angle. In this specification the amplitude of the helix refers to the extent of displacement from a mean position to a lateral extreme.
  • the amplitude is one half of the full lateral width of the helical centreline.
  • the helical tubing can be regarded as occupying an imaginary envelope which extends longitudinally and has a width equal to the swept width of the helical tubing.
  • the tubing and the flow lumen defined thereby extend longitudinally and helically and the helical tubing forms an imaginary envelope which extends longitudinally and has a width equal to the swept width of the helical tubing.
  • the envelope may be regarded as having a central longitudinal axis, referred to also as an axis of helical rotation. Where the axis of helical rotation is straight then the envelope occupied by the helical tubing will be generally cylindrical.
  • Catheter tubing typically has an external diameter smaller than the internal diameter of the vessel into which it is to be inserted.
  • the external diameter of the helical tubing of the present invention is preferably smaller than the internal diameter of the vessel for which it is intended. This ensures that the flow external of the tubing in the vessel is not blocked.
  • the preferred helical tubing when in a vessel engages with the inner wall of the vessel.
  • the helical tubing effectively forms a helical rib projecting radially inwardly from the vessel wall and tending to promote swirl flow in the region of the vessel wall at least.
  • the engagement of the helical tubing with the inner wall of the vessel can be achieved by over sizing the helical tubing relative to the inner diameter of the vessel.
  • the envelope which it occupies has a width greater than that of the internal diameter of the vessel.
  • a catheter having a helical tubing with an envelope having a diameter greater than the internal diameter of the vessel may be selected.
  • a range of different catheters may be provided for appropriate uses.
  • the tubing By making the tubing from a resilient material, such as plastics, the tubing can adopt the required smaller envelope width in vivo as compared to its width ex vivo.
  • the resilience of the tubing can ensure the engagement between the tubing and the vessel wall, so that the tubing is centred in the vessel.
  • the external surface area of the tubing should not be too large as a larger external surface area creates more opportunity for thrombosis to develop.
  • Tubing of larger cross sectional areas will also tend to reduce the cross section of the vessel available for flow externally of the tubing, and so may lead to an undesirable level of pressure drop caused by the presence of the catheter.
  • the external diameter of the tubing is less than or equal to half of the width of the envelope.
  • a smaller external diameter of the helical tubing means that it will have a greater helical amplitude.
  • the amplitude of the helical centreline of the tubing is greater than one quarter of the width of the envelope defined by the swept width of the tubing. This means, in most cases, and in the case of a tubing and a vessel with circular cross- sections, that there is a "line of sight" along the centre of the vessel, unimpeded by the tubing. In other words the helical tubing rotates around a "virtual" core. This is like the configuration of a corkscrew.
  • the amplitude is greater than 0.3 of the width swept by the helical tubing (the width of the envelope) when ex vivo.
  • the ratio of the amplitude of the helical tubing to the width of the envelope ex vivo is greater than 0.3.
  • the ratio may be greater than 0.4, 0.5, 0.6, 0.7, 0.8, 0.9, 1, 1.1, 1.2, 1.3, 1.4, 1.5, 1.6, 1.7, 1.8, 1.9, 2.0, 2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8, 2.9 or 3.0.
  • flow in the lumen of the vessel at its centre will tend not to be significantly influenced by the helical tubing at the radial periphery of the vessel lumen. The flow will be most influenced, however ⁇ in the important region near to the inner wall of the vessel where it is expected that the promotion of swirl flow will reduce any tendency to flow stagnation.
  • the helix angle should not be too large as this may create an obstruction to flow near the vessel inner wall and have the opposite of the desired effect.
  • the helix angle is preferably less than or equal to 65° (measured with respect to the axis of helical rotation), more preferably less than or equal to 55°, 45°, 35°,
  • helix angle is less than 20° or less than 15°. If the swept width of the helical tubing ex vivo is greater than its swept width when in vivo, as discussed above, then there will be a reduction in the helix angle when the tubing is placed in a vessel as the tubing tends to be straightened out when it is laterally constrained. Thus the helix angle ex vivo will be chosen to be slightly larger than the requirement when in vivo.
  • the helical tubing may have a distal end portion which is positioned radially inwardly of the imaginary envelope.
  • the helical tubing engages with the inner wall of the vessel. Then, if the distal end portion is positioned radially inwardly of the imaginary envelope, it will tend to be positioned at a radial spacing from the inner wall. This has the advantage of avoiding problems with clogging with the end region of the tubing, where it typically has an opening communicating the flow lumen of the tubing with the vessel.
  • the distal end portion of the tubing does not lie on the vessel wall, there is a reduced risk of flow stagnation around the opening or of clotting or tissue ingrowth in the opening. This may lead to an increased useful life of the catheter.
  • the radial spacing of the distal end portion of the catheter from the inner wall of the vessel may also facilitate removal of the catheter when required, as this end portion will normally not be adhered to the vessel inner surface by tissue, clotting or other material.
  • the helical amplitude of the tubing decreases towards the distal end thereof.
  • the helical tubing When the helical tubing is in use and engages with the inner wall of the vessel, if the helical amplitude decreases towards the distal end, that end will tend to be positioned at a radial spacing from the inner wall. If the helical amplitude decreases towards zero, the end of the tubing will tend to adopt a generally central position in the vessel.
  • a reducing helical amplitude is one way of achieving a position of the catheter distal end portion at a radially inward spacing from the vessel inner wall.
  • the side portion of the tubing which when inserted in the vessel faces radially outwardly with respect to the vessel is fenestrated or porous.
  • Such holes or pores can provide a flow through the radially outer part of the tubing and this may inhibit the development of an adherent coating on this side portion which would otherwise cause the tubing to stick to the vessel wall.
  • a catheter is easier to remove.
  • the tubing is arranged so that a flow lumen feeding flow to the vessel, rather than a flow lumen for aspiration, has the radially outwardly facing portion which is fenestrated or porous, hi these embodiments, the flow will be outward, from the flow lumen of the tubing to the vessel, via the pores or holes, and so benefit the aim of reducing a tendency for the tubing to stick to the vessel wall.
  • the tubing may be made from non-porous material with holes formed in the radially outwardly facing side portion. It may be made from a combination of a porous material and a non-porous material. In certain preferred embodiments, the tubing is made from a porous material and has a non-porous layer on a side which when in use in the vessel faces radially inwardly with respect to the vessel.
  • the preferred tubing is formed to extend longitudinally and helically, it will be known in advance of insertion in a vessel which portions will face radially outwardly with respect to the vessel, and which portions will face radially inwardly.
  • the tubing may have a single flow lumen, for example if it is to be used as an intravenous drip, or it may define a plurality of flow lumens.
  • catheters used for dialysis treatment have two flow lumens, one for suction from the vessel and one for return to the vessel.
  • the tubing has a plurality of flow lumens, for example two flow lumens.
  • each flow lumen has an opening for communication with the vessel and the openings of the respective lumens are axially separated. At least in the case of a catheter used for dialysis, axial separation is generally desirable to avoid blood which has been dialysed being immediately returned to the dialyser unit.
  • Plural flow lumens may be defined by respective tubes. Such tubes may be joined together by a longitudinally extending seam and/or they may be contained in a sheath. In one example, a pair of flow lumens of generally circular cross-section are arranged side by side, whereby the tubing has a figure of "8" cross-sectional shape. This arrangement may be formed by a pair of tubes joined along a longitudinally extending seam, or by two tubes held together in a sheath.
  • An alternative construction may involve a pair of generally "D" shaped flow lumens which, in cross section, are joined along the straight portions of the "D".
  • the tubing may have a generally circular cross-sectional shape, with the circle being divided into two generally semi-circular flow lumens.
  • the respective flow lumens may have distal end parts which extend bundled together.
  • the distal end parts may form the distal end portion of the helical tubing which is positioned radially inwardly of the imaginary envelope.
  • the distal end parts of the respective flow lumens may extend bundled together as the helical amplitude of the tubing decreases towards the distal end thereof.
  • the tubing has a helical centreline.
  • the helical centreline of the tubing will correspond to the helical centreline of the flow lumen, hi the case of tubing having plural flow lumens, then the helical centreline will normally follow a different path from the helical centrelines of the respective flow lumens (unless the flow lumens are formed co-axially, i.e. with a central inner tube concentric with an outer tube).
  • the path of the helical centreline will be determined by the locus of the centroids of the tubing as a whole, rather than by the centroids of individual flow lumens.
  • the feature of the outer surface portion of the tubing extending longitudinally and helically so as to induce swirl flow in a vessel may be achieved by the helical outer surface portion protruding radially outwardly from circumferentially adjacent portions of the tubing.
  • the tubing may comprise one or more helically extending ribs.
  • the tubing itself may for example be cylindrical (rather than helical) with at least one external helical rib.
  • this arrangement leads to a larger external surface area of the tubing, with a possible increased risk of thrombosis. It is therefore preferred that the tubing as a whole (and the flow lumen defined internally thereof) extends longitudinally and helically, i.e. so as to form helical tubing.
  • the catheter may comprise conventional non-helical tubing in addition to the tubing which induces swirl flow. It may for example have helical tubing at a downstream location and non-helical tubing upstream thereof. For example where the tubing is expected to pass through a patient's skin it may be non-helical, whilst where it is expected to lie in a vessel then it may be helical.
  • the tubing may be made from material typically used to manufacture the tubing of catheters, for example plastics or metals.
  • Helical tubing may be manufactured by winding the tubing around a mandrel, hi the case of tubing made of plastics, the tubing may be heat set in the helical condition when on a mandrel and then the mandrel removed. It may be desirable to use a member internally of the tubing so as to prevent the flow lumen from being flattened when the tubing is deformed into the helical configuration.
  • a preferred embodiment of the catheter may be inserted in a patient as follows.
  • a vessel such as a blood vessel is punctured by a needle, a guide wire is inserted into the vessel via the bore of the needle, the needle is withdrawn, and the helical tubing is placed over the guide wire and advanced so that its front end extends into the vessel and its rear end is external of the patient.
  • the guide wire is withdrawn leaving the catheter in place.
  • helical tubing it will tend to be straightened out by the guide wire, with a reduction in helical amplitude and an increase in pitch, but the tubing material will be such that it returns to a helical shape after the guide wire is withdrawn.
  • the use of conventional biocompatible plastics material with resilient elastic properties can achieve the desired effect. Other methods of deployment of the catheter may of course be used.
  • Figure 1 is a side view of helical tubing forming part of a catheter.
  • Figure 2 is a cross-section of the helical tubing of Figure 1, to an enlarged scale;
  • Figure 3 shows the downstream end of a catheter in a vessel
  • Figure 4 shows an end elevation of the downstream end of the catheter of
  • Figure 5 is an enlarged view of the tip of the catheter of Figure 3;
  • Figure 6 is a cross-section on the lines VI - VI of Figure 3.
  • Figure 7 is a cross-section similar to that of Figure 2 but showing helical tubing of another embodiment in a vessel.
  • the helical tubing 2 shown in Figures 1 and 2 has a pair of tubes 4 and 5, one located inside the other.
  • an inner tube 4 is located inside an outer tube 5.
  • the outer surface 7 of the tubing is therefore formed by the outer surface of the outer tube 5.
  • the tubing 2 is coiled into a helix of constant amplitude A (as measured from mean to extreme), constant pitch P, constant helix angle ⁇ and swept width W.
  • the tubing 2 is contained in an imaginary envelope 8 which extends longitudinally and has a width equal to the swept width W of the tubing 2.
  • the envelope 8 may be regarded as having a central longitudinal axis 10, which may also be referred to as an axis of helical rotation.
  • the illustrated helical tubing has a straight longitudinal axis 10, but it will be appreciated that in alternative designs the longitudinal axis may be curved.
  • the helical tubing has a centreline 12 which follows a helical path about the central longitudinal axis 10.
  • FIGS 3, 4 and 6 show the catheter 1 in a blood vessel 14.
  • the blood vessel has an inner wall 18 which defines the vessel flow lumen 19.
  • the inner wall 18 is engaged by an engagement portion 20 of the outer surface 7 of the tubing 2 along a helical engagement region.
  • the outer surface engagement portion 20 is that part of the surface of the tubing which faces radially outwardly with respect to the vessel. Alternatively, it can be considered as facing radially outwardly with respect to the central longitudinal axis 10, i.e. the axis of helical rotation.
  • the tubing forms a helical rib following the inside surface of the vessel 14 so as to create rotating flow in the region of the vessel inner wall 18.
  • the direction of blood flow is shown by an arrow 24.
  • Figure 6 is a cross-sectional view of the catheter in a vessel.
  • the inner tube 4 can be seen inside the outer tube 5 where the section is taken, and the outer surface 7 of the tubing 2 is then seen in elevation.
  • the engagement portion 20 of the outer surface 7 of the tubing 2 engages the vessel inner wall 18 along the helical engagement region.
  • the tube 4 of the tubing 2 is intended as an aspirating tube, for aspirating blood from the patient and passing it to a dialyser unit (not shown).
  • the tube 4 has an inlet opening 26.
  • Tube 5 is intended as a return tube, to return dialysed blood to the vessel and has an outlet opening 28.
  • the outlet opening 28 is downstream of the inlet opening 26 in order to avoid or minimise recirculation of dialysed blood back to the dialyser unit.
  • This arrangement is shown in Figure 3 and further details are shown in the enlarged view of Figure 5.
  • Inner tube 4 passes through an opening 11 in the wall of outer tube 5 in a sealed manner.
  • the outer tube 5 could be the aspirating tube and the inner tube 4 the return tube, and in these arrangements the inner tube would preferably extend so that its opening communicating to the vessel lumen 19 is downstream of the opening of the outer tube with respect to the flow in the vessel.
  • Alternative tubing configurations are of course possible within the scope of the invention.
  • the aspirating tube and the return tube may be two tubes placed side by side, so that the cross-section is generally that of the number "8".
  • Another example may have tubing of a generally circular cross-sectional shape, with the circle being partitioned into two generally "D" shaped flow passages. More than two flow lumens may be provided in certain embodiments.
  • Tubing which comprises only a single flow lumen may be provided as part of a catheter for uses other than haemodialysis.
  • the helical tubing has a downstream end portion 3 where its helical amplitude A reduces. This is shown in the right hand part of Figure 3 and in Figure 4.
  • the amplitude Al identified at the left of Figure 3 is equal to the full amplitude A of the tubing in the vessel.
  • Amplitude A2 which is closer to the distal tip, is smaller than amplitude A. This ensures that the inlet 26 and outlet 28 are radially inwardly spaced from the inner wall 18 of the vessel. This arrangement advantageously avoids these openings becoming blocked by clots or just through contact with the inner wall.
  • the helical nature of the tubing 2 enables it to adopt a predetermined position in the vessel, in the sense that it engages the vessel inner wall along a helical engagement region, whilst permitting the inlet and outlet openings to be radially inwardly spaced from the wall.
  • the engagement portion 20 of the outer surface 7 of the tubing 2 may be fenestrated or porous so that a flow may pass through the tubing wall.
  • the wall being fenestrated or porous in this region, where it engages with the inner wall 18 of the vessel, the flow can reduce a tendency for thrombosis at the contact area.
  • FIG. 7 an embodiment of helical tubing 2 is shown where the outer tube 5 is entirely formed of porous material which is then provided with a non-porous coating 32 over part of its periphery, thereby creating a porous engagement portion 20 at its radially outer region.
  • the tube functioning as the return tube which is in the radially outermost position, although the aspiration tube may alternatively be in the radially outermost position.
  • it is not important whether one lumen or the other is in a radially outermost position compared to the other.

Abstract

La présente invention concerne un cathéter destiné à être inséré dans un vaisseau du corps humain ou animal, le cathéter comprenant une tubulure définissant une lumière d’écoulement, la tubulure ayant une partie de surface extérieure qui s’étend longitudinalement et en hélice de manière à induire un écoulement en tourbillon dans un vaisseau à l’extérieur de la tubulure lors de son utilisation dans le vaisseau.
PCT/GB2009/002843 2008-12-08 2009-12-08 Cathéters WO2010067062A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0822357A GB0822357D0 (en) 2008-12-08 2008-12-08 Spiral catheter
GB0822357.0 2008-12-08

Publications (1)

Publication Number Publication Date
WO2010067062A1 true WO2010067062A1 (fr) 2010-06-17

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Application Number Title Priority Date Filing Date
PCT/GB2009/002843 WO2010067062A1 (fr) 2008-12-08 2009-12-08 Cathéters

Country Status (2)

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GB (1) GB0822357D0 (fr)
WO (1) WO2010067062A1 (fr)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0386408A1 (fr) * 1989-03-09 1990-09-12 B. Braun Melsungen AG Cathéter
WO1996013295A1 (fr) * 1994-10-20 1996-05-09 Micro Therapeutics, Inc. Dispositif de perfusion preforme
US5873865A (en) * 1997-02-07 1999-02-23 Eclipse Surgical Technologies, Inc. Spiral catheter with multiple guide holes
US20030144623A1 (en) * 2002-01-29 2003-07-31 Heath Kevin R. Occlusion-resistant catheter

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0386408A1 (fr) * 1989-03-09 1990-09-12 B. Braun Melsungen AG Cathéter
WO1996013295A1 (fr) * 1994-10-20 1996-05-09 Micro Therapeutics, Inc. Dispositif de perfusion preforme
US5873865A (en) * 1997-02-07 1999-02-23 Eclipse Surgical Technologies, Inc. Spiral catheter with multiple guide holes
US20030144623A1 (en) * 2002-01-29 2003-07-31 Heath Kevin R. Occlusion-resistant catheter

Also Published As

Publication number Publication date
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